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BleaseSirius

Anesthesia Systems
User Manual
BleaseSirius User Manual 073-0212-00/REV. 1B
2 BleaseSirius User Manual
BleaseSirius

User
Manual
MODIFICATIONS LABEL

ECO A ECO B ECO C ECO D ECO E

PR023470 PR023930
ECO F ECO G ECO H ECO I ECO J

Spacelabs Healthcare Ltd.


(Anesthesia Delivery and Ventilation Division)
1 Harforde Court John Tate Road Hertford
SG13 7NW United Kingdom
Tel: +44 (0)1992 507700
Fax: +44 (0)1992 501213
e-mail (enquiries): advsales@spacelabs.com
e-mail (technical): advsupport@spacelabs.com
www.spacelabshealthcare.com Part Number: 073-0212-00
Rev. B/ December 2010
This User Manual applies to the following software versions:
Front Panel Software V10.05 or later
Control Board Software V9.61 or later
(See section 2.2.27.9 for instructions on how to access information on which software version
currently running on the ventilator).

BleaseSirius User Manual 3


Preface

4 BleaseSirius User Manual


Preface

Section 1 BLEASESIRIUS ANESTHETIC MACHINE


Section 2 700/900 SERIES VENTILATORS
Section 3 CAS I & II ABSORBER
Section 4 NOTICES AND IMPORTANT INFORMATION

IMPORTANT
The user must be familiar with the machine and its various functions
before using it on a patient.

Federal law restricts this device for sale by or on the order of a


physician.

Incorrect use of the equipment described herein may result in injury to


the patient. Read this manual before operating the machine. You must be
familiar with the machine and its functions before using it on a patient.

Be sure to pay special attention to warnings, cautions and notes within


the manual. A full list of these can be found in Section 4 of this manual.

Warning Notices

Warning notices denote a potential hazard to the health and safety


of users and/or patients. These notices clearly state the nature of the
respective hazard and the means by which it can be avoided.
Warning notices appear in full in the preliminary pages and are repeated
at their points of application in the manual.

Caution Notices

Cautionary notices denote a potential hazard to the physical integrity


of equipment/software but NOT a danger to personnel. These notices
clearly state the nature of the hazard and the means by which it can be
avoided.

Notes
This symbol signifies relevant or helpful information.

BleaseSirius User Manual 5


Preface

Notes

6 BleaseSirius User Manual


Contents
How to Use This Manual ............................................................................ 19

Section 1 - BleaseSirius System ............................................................... 21


1.1 Introduction .....................................................................................................25
1.2 Description ......................................................................................................27
1.2.1 General ....................................................................................................27
1.2.2 The Frame ...............................................................................................31
1.2.3 Pneumatic Assembly ...............................................................................31
1.2.4 The Monitor Shelf ....................................................................................31
1.3 Specification ....................................................................................................32
1.3.1 Physical ...................................................................................................32
1.3.1.1 Machine Dimensions ..................................................................32
1.3.1.3 Monitor Shelf Dimensions ..........................................................32
1.3.2 Maximum Loading ......................................................................32
1.3.3 Pneumatics .............................................................................................33
1.3.3.1 Gas-Specific Color Specifications ..............................................33
1.3.3.2 Electrical Cable Color Specifications .........................................33
1.3.3.3 Miscellaneous ............................................................................33
1.3.3.4 Common Gas Outlet ..................................................................33
1.3.4 Technical/Performance Specifications .....................................................34
1.3.4.1 Controls ......................................................................................34
1.3.4.2 Ventilator ....................................................................................34
1.3.4.3 Alarms/Indicators .......................................................................35
1.3.4.4 Regulator Safety Valve Settings.................................................35
1.3.4.5 Electrical Specifications .............................................................35
1.3.4.6 Gas Flows ..................................................................................36
1.3.4.7 Environmental Conditions ..........................................................36
1.3.5 Ancillary and Optional Features...............................................................37
1.3.5.1 Vaporizers ..................................................................................39
1.4 Installation .......................................................................................................40
1.4.1 Install the Cylinders .................................................................................40
1.4.1.1 Install the Large Cylinders (Optional) .........................................42
1.4.2 Connect the Pipelines ..............................................................................43
1.4.3 Connect the Oxygen Transducer ............................................................43
1.4.3.1 Guidelines for Handling the Oxygen Sensor ..............................45
1.4.4 Install the Selectatec Vaporizers..............................................................45

BleaseSirius User Manual 7


Contents
1.4.5 Install the CAS Absorber..........................................................................49
1.4.6 Install the Extended Work Surface (Optional)..........................................50
1.4.7 Patient Airway Flow Sensor .....................................................................51
1.4.7.1 Filter ...........................................................................................52
1.4.8 Suction Controller ....................................................................................54
1.4.8.1 Fitting the Suction Controller .....................................................54
1.4.8.2 Suction Controller Features .......................................................55
1.4.8.3 Testing the Suction System ........................................................55
1.4.8.4 Cleaning .....................................................................................55
1.4.9 Installing Ancillary Equipment (optional) ..................................................55
1.4.10 Ventilators ................................................................................................58
1.4.11 Post-Installation Check ............................................................................58
1.5 Theory of Operation ........................................................................................58
1.5.1 C.G.O. Pressure Relief Valve ..................................................................61
1.5.2 Oxygen System and Oxygen Failure Warning Device .............................64
1.5.3 Nitrous Oxide System (Optional) .............................................................66
1.5.4 Medical Air System (Optional) ................................................................67
1.5.5 Controls ...................................................................................................68
1.5.5.1 On/Off Switch .............................................................................68
1.5.5.2 Flow Controls .............................................................................68
1.5.5.3 Auxiliary Flowmeter ....................................................................71
1.5.5.4 Oxygen Flush, O2 + Button ........................................................71
1.5.5.5 Hypoxic Guard ..........................................................................71
1.5.5.6 Vaporizers ..................................................................................72
1.5.5.7 Brake Pedal................................................................................72
1.5.5.8 Drawers ......................................................................................73
1.5.5.9 Flowmeter Backlight and Da-lites...............................................73
1.5.5.10 Maneuvering the Machine ..........................................................74
1.6 User Maintenance Schedule ...........................................................................75
1.7 Pre-Use Checks.......................................................................................75
1.7.1 Gas Supply Hoses and Probes Check ....................................................75
1.7.2 Cylinder and Pipeline Supplies Check .....................................................76
1.7.3 Flowblock Assemblies Check ..................................................................76
1.7.4 Oxygen Failure Warning System Check .................................................76
1.7.5 Leak Test -Vaporizers ..............................................................................77

8 BleaseSirius User Manual


Contents

1.7.6 C.G.O. Safety Valve.................................................................................78


1.7.7 A. C.G.O. Safety Valve (if installed) .........................................................78
1.7.8 General ....................................................................................................78
1.8 Full System Test ..............................................................................................79
1.8.1 Leak Test .................................................................................................79
1.8.2 On/Off Switch and Warning System Checks ...........................................80
1.8.3 Mechanical Hypoxic Guard Test ..............................................................81
1.8.4 Oxygen Flush Tap Test ............................................................................81
1.8.5 Auxiliary Outlet Test .................................................................................81
1.8.6 HP Outlet Test (if installed) ......................................................................81
1.8.7 Ventilator Test ..........................................................................................82
1.9 Cleaning ..........................................................................................................82
1.10 Sterilization......................................................................................................82

Section 2 700/900 Series Ventilators ....................................................... 83


2.1 Description of the Ventilator ............................................................................85
2.1.1 Overview .................................................................................................85
2.1.2 Features...................................................................................................86
2.2.2.1 Controls and Indicators ................................................. 86
2.2.2.2 Microprocessor Control ............................................................86
2.2.2.3 Dual Mode Ventilation ..............................................................86
2.2.2.4 Pressure Limit Control ..............................................................86
2.2.2.5 Built-in Ventilator Pre-use Test ...................................................86
2.2.2.6 Comprehensive Pressure Monitoring and Alarms .....................86
2.1.2.7 Waveforms and Spirometry ......................................................87
2.1.2.8 Battery Back Up .......................................................................87
2.1.3 Operating Modes .....................................................................................88
2.1.3.1 Volume Control...........................................................................89
2.1.3.2 Precision Pressure Control ........................................................89
2.1.3.3 SIMV-PC + PSV and SIMV-VC + PSV Modes ...........................90
2.1.3.4 Inspiratory Pause .......................................................................91
2.1.3.5 Sigh ............................................................................................91
2.1.3.6 Advanced Pressure Support .....................................................92
2.1.4 Principles of Operation ..........................................................................93
2.1.5 Parameters .............................................................................................95
2.1.5.1 PEEP..........................................................................................95

BleaseSirius User Manual 9


Contents

2.1.5.3 Support Pressure .......................................................................96


2.1.5.4 Fresh Gas Compensation ..........................................................96
2.2.5.5 Oxygen .......................................................................................96
2.1.5.6 Tidal Volume ..............................................................................96
2.1.5.7 Minute Volume ...........................................................................97
2.1.5.8 Expired Tidal volume ..................................................................97
2.1.5.9 BPM (Frequency Control) ..........................................................97
2.1.5.10 I:E Ratio .....................................................................................97
2.1.5.11 Pressure Limit ............................................................................97
2.1.5.12 Pressure Control/ Ptot ................................................................97
2.1.5.13 Peak Pressure............................................................................97
2.1.5.14 Mean Pressure ...........................................................................97
2.1.5.15 Plateau Pressure (Pplat) ............................................................97
2.1.5.16 Compliance ................................................................................97
2.1.5.17 Volume Measurement ................................................................98
2.1.5.18 Oxygen Measurement ................................................................98
2.1.6 User Interface ..........................................................................................99
2.1.6.1 Front Panel.................................................................................99
2.1.6.2 Normal Screen .........................................................................100
2.1.6.3 Activity Display Area.................................................................100
2.1.6.4 Alarms Display Area .................................................................101
2.1.6.5 Measurements Display Area ....................................................101
2.1.6.6 Parameter Display Area ...........................................................101
2.1.6.6 Trak Wheel & Touch Screen .................................................102
2.1.7 Battery Status LEDs ..............................................................................104
2.1.8 Menu Tree ............................................................................................105
2.1.8.1 Setup Menu ...............................................................................105
2.1.8.2 Defaults Menu..........................................................................106
2.1.8.3 Alarm Setup ...........................................................................106
2.2 Using the Ventilator .......................................................................................107
2.2.1 Power On the Ventilator .........................................................................107
2.2.2 Start the Ventilator .................................................................................107
2.2.3 Stop the Ventilator .................................................................................108
2.2.5 End of Case ...........................................................................................108
2.2.6 Power Off the Ventilator .........................................................................108

10 BleaseSirius User Manual


Contents

2.2.8 Pre-Use Test Error Messages...............................................................113


2.2.9 Absorber Not Installed ...........................................................................116
2.2.10 Fresh Gas ..............................................................................................116
2.2.11 Standby/Bag Modes ..............................................................................117
2.2.12 I:E Setting ..............................................................................................119
2.2.13 Oxygen Calibration ................................................................................120
2.2.13.1 O2 Calibration with A.C.G.O. System .......................................121
2.2.14 The Measurements Menu.....................................................................122
2.2.15 Adult and Pediatric Modes .....................................................................123
2.2.16 Auxilliary Common Gas Outlet (A.C.G.O.) Option .................................123
2.2.17 Types of Flow Sensors ..........................................................................124
2.2.18 Sensor Placement .................................................................................125
2.2.18 The Waveform Select Menu ..................................................................128
2.2.19 Save a Spirometry Loop ........................................................................128
2.2.19.1 Recall a Spirometry Loop .........................................................129
2.2.19.2 Example Spirometry Loops ......................................................130
2.2.20 Airway Pressure Waveform ...................................................................132
2.2.20.1 Airway Flow Waveform ............................................................132
2.2.21 Ventilation Mode Menu .........................................................................133
2.2.21.1 Pause .......................................................................................133
2.2.21.2 Pause + Sigh settings ..............................................................134
2.2.21.3 Cardiac Bypass ........................................................................134
2.2.22 Setting Parameters ................................................................................134
2.2.23 Alarms....................................................................................................134
2.2.23.1 Alarms Summary......................................................................136
2.2.23.2 Pre-set Alarms..........................................................................137
2.2.24 User Defined Alarms ..............................................................................141
2.2.24.1 Apnea Alarm.............................................................................141
2.2.24.2 Low Oxygen Alarm ...................................................................141
2.2.24.3 High Oxygen Alarm ..................................................................141
2.2.24.4 High BPM Alarm .......................................................................141
2.2.24.5 Pressure Limit Alarm ................................................................141
2.2.24.6 Low BPM Alarm........................................................................142
2.2.24.7 MV High Alarm .........................................................................142
2.2.24.8 MV Low Alarm ..........................................................................142
2.2.24.9 Pressure Low Alarm .................................................................142
BleaseSirius User Manual 11
Contents

2.2.25 Auto Alarms ...........................................................................................143


2.2.26 The Alarms Setup Menu ........................................................................144
2.2.26.1 Set the Alarms ..........................................................................144
2.2.26.2 Alarm Mute ...............................................................................145
2.2.26.3 Set the Apnea Time Alarm .......................................................145
2.2.26.4 Selecting/Deselecting PAW <-10cmH2O ..................................146
2.2.27 The Defaults Menu ................................................................................146
2.2.27.1 Save Hospital Default Settings.................................................147
2.2.27.2 Save and Recall Settings .........................................................147
2.2.27.3 Change Names ........................................................................148
2.2.27.4 Save Current Settings ..............................................................149
2.2.27.5 Recall Settings .........................................................................149
2.2.27.6 Changing/Entering New Password ..........................................149
2.2.27.7 Configuration ...........................................................................150
2.2.27.8 Service Mode ...........................................................................150
2.2.27.9 System Information ..................................................................150
2.2.27.10 System Audit Trail ..................................................................151
2.3 Installation .....................................................................................................152
2.3.1 Pre-Use Checks...................................................................................154
2.3.2 Discharged Battery ................................................................................156
2.3.3 Installing the Adult Bellows ....................................................................158
2.3.4 Pre-use Test...........................................................................................159
2.3.4.1 Fresh Gas ................................................................................159
2.3.4.2 Compliance Test.......................................................................159
2.4 Routine User Maintenance............................................................................161
2.4.1 Monthly Check .......................................................................................161
2.4.1.1 Control Unit ..............................................................................161
2.4.2 Six-Month Check ...................................................................................161
2.4.2.1 Bellows .....................................................................................161
2.4.3 Other Maintenance ...............................................................................161
2.4.4 Cleaning and Sterilization .....................................................................162
2.4.4.1 Ventilator Surfaces ...................................................................162
2.4.4.2 Patient Flow Sensor and Tubing ..............................................162
2.4.4.3 Bellows .....................................................................................164
2.4.4.4 Pop-off Valve Seat ...................................................................164

12 BleaseSirius User Manual


Contents

2.4.5 Methods of Sterilization .........................................................................165


2.5 Troubleshooting.............................................................................................166
2.6 Performance Data .........................................................................................168
2.6.1 Notes on Performance Data ..................................................................168
2.6.2 Factory Default Settings ...........................................................169
2.6.2.4 SIMV PC+ PSV Defaults at Startup .........................................170
2.7 Associated Equipment and Accessories .......................................................172
2.8 External Communication Specification..........................................................173
2.8.1 Data Transmission Settings ...................................................................173
2.8.2 Protocol..................................................................................................173
2.8.3 Pin Connections.....................................................................................174
2.8.4 Set Messages ........................................................................................174
2.8.5 Breathing Modes....................................................................................174
2.8.6 Breathing Control ...................................................................................175
2.8.7 Measured Value Messages ...................................................................175
2.8.8 Event Message ......................................................................................177
2.8.9 User/System Settings ..............................................................................177
2.8.10 User Alarm Limits ..................................................................................178
2.8.11 Waveform Information............................................................................178
2.10 Error Codes ...................................................................................................181

Section 3 CAS I/II Absorber .................................................................... 183


3.1 Description ....................................................................................................186
3.1.1 Introduction ............................................................................................186
3.1.2 Principles of Operation ..........................................................................187
3.1.2.1 Spontaneous Breathing............................................................187
3.1.2.2 CO2 Bypass (not available in US) ............................................187
3.1.2.3 Scavenging ..............................................................................187
3.1.2.4 Absorbent .................................................................................187
3.2 Installation .....................................................................................................189
3.2.1 Install the Absorber on the Machine ......................................................189
3.2.2 Fill the Soda Lime Canister(s) ...............................................................189
3.2.2.1 For Disposable Soda Lime Canister(s) ....................................191
3.2.2.2 For Reusable Soda Lime Canister(s) .......................................191
3.2.3 Bag Arm Link Pipe .................................................................................192

BleaseSirius User Manual 13


Contents

3.2.4 Attach the Breathing Circuit Tubing .......................................................193


3.2.5 Pre-Use Checks.....................................................................................194
3.2.5.1 Compliance Test ......................................................................195
3.2.5.2 Spontaneous Breathing Setup .................................................195
3.3 Absorber Maintenance ..................................................................................196
3.3.1 Change the Canister Soda Lime............................................................196
3.3.1.1 Replace the Reusable Canister Soda Lime .............................196
3.3.1.2 Absorbent Capacity of Canister Soda Lime .............................197
3.3.1.3 When to Replace the Soda Lime .............................................197
3.3.1.4Change a Disposable Canister ..............................................................199
3.3.1.5 Storage of Soda Lime ..............................................................200
3.3.2 Cleaning and Sterilization ......................................................................200
3.3.3 Routine Maintenance Checks ................................................................202
3.4 Spare Parts and Accessories ........................................................................204
3.5 Manometer ....................................................................................................205
3.5.1 Install the Manometer ............................................................................205
3.5.2 Remove the Manometer ........................................................................205
3.6 Oxygen Sensor .............................................................................................205
3.7 Absorber Technical Data ...............................................................................206
3.7.1 Dimensions ...................................................................................................206
3.7.2 Performance ..........................................................................................206
3.7.2.1 Performance as defined in EN 740:1999 E. .............................206

Section 4 Notices & Important Information............................................ 207


4.1 Product Improvement ....................................................................................209
4.2 Responsibilities of the User...........................................................................209
4.3 Responsibilities of the Manufacturer .............................................................209
4.4 Disclaimer .....................................................................................................210
4.5 Technology Disclaimer / Tamper Proof Seal .................................................210
4.6 Note to Service Personnel ............................................................................210
4.7 Copyright .......................................................................................................211
4.8 CE Marking ...................................................................................................211
4.9 Trademarks and Acknowledgements ............................................................212
4.10 Hazard Notices.............................................................................................213
Appendix 1: EMC Tests for IEC 60601-1-2 Compliance ..........................................246

14 BleaseSirius User Manual


List Of Figures

Figure 1 - BleaseSirius Anesthetic Machine ...............................................................28


Figure 2 - Back of BleaseSirius ..................................................................................30
Figure 3 - Electrical Labeling ......................................................................................36
Figure 4a - Installing the Cylinders .............................................................................41
Figure 4b - Installing Large Cylinders.........................................................................41
Figure 5 - Connect the Oxygen Sensor ......................................................................44
Figure 6 - CAS Absorber and Components ................................................................48
Figure 7 - CAS Absorber Mounting Brackets .............................................................49
Figure 8 - Extended Work Surface Open ..................................................................50
Figure 9 - Extended Work Surface Operation ............................................................50
Figure 10 - Extended Work Surface Closed .............................................................50
Figure 11 - Patient Airway Flow Sensor .....................................................................51
Figure 12a - Filter Set Up ...........................................................................................53
Figure 12b - Filter Set Up ...........................................................................................53
Figure 13 - Suction Controller ....................................................................................54
Figure 14 - BleaseSirius Anesthetic Machine Components .......................................56
Figure 15 - Pneumatic Circuit for the Mechanical Flowmeter.....................................62
Figure 16 - Mechanical Flowmeter .............................................................................68
Figure 17 - Electronic Flowmeter, 3 Gas Option ........................................................69
Figure 18- Gas Consumption Data, System Information Screen ...............................70
Figure 19 - Select Backlight Screens .........................................................................73
Figure 20 - System Handle Locations ........................................................................74
Figure 21 - 900 Series Ventilator ................................................................................85
Figure 22 - Low Battery Indicator ...............................................................................87
Figure 23- Volume & Precision Pressure Control Mode Waveforms ..........................89
Figure 24 - Inspiratory Pause Waveform ....................................................................91
Figure 25 - Pressure/Flow/Volume Waveform ............................................................92
Figure 26 - Pneumatic System ...................................................................................94
Figure 27 - PEEP Waveform ......................................................................................95
Figure 28 - Ventilator Front Panel ..............................................................................99
Figure 29 - Normal Run Screen ...............................................................................100
Figure 30 - Home Key ..............................................................................................100
Figure 31 - Activity Display Area...............................................................................100
Figure 32 - Parameter Display Area .........................................................................102
Figure 33 - Setup Menu Tree ...................................................................................105

BleaseSirius User Manual 15


List Of Figures

Figure 34 - Defaults Menu Tree................................................................................106


Figure 35 - Alarm Setup Menu Tree ........................................................................106
Figure 36 - Bag/Vent Switch - Vent ..........................................................................107
Figure 37 - Bag/Vent Switch - Bag ...........................................................................108
Figure 38 - End of Case Options ..............................................................................108
Figure 39 - Pre-use Opening Screen at Power-On ..................................................109
Figure 40 - Verification Screen if you choose to skip the Compliance Check ..........109
Figure 41 - Start Screen for the Pre-Use Tests ........................................................109
Figure 42 - Pre-use Occlusion Tests Screens ..........................................................110
Figure 43 - Leak Test Screens .................................................................................110
Figure 44 - Perform System Check Screen.............................................................. 111
Figure 45 - System Test Confirmation Screen .......................................................... 111
Figure 46 - System Test Screens ............................................................................. 111
Figure 47 - Compliance Check Passed Message ....................................................112
Figure 48 - Pre-use Test Error Message (01) ...........................................................113
Figure 49 - Pre-use Test Error Message (02) ...........................................................113
Figure 50 - Pre-use Test Error Message (03) ...........................................................113
Figure 51 - Pre-use Test Error Message (04) ...........................................................114
Figure 52 - Pre-use Test Error Message (05) ...........................................................114
Figure 53 - Pre-use Test Error Message (06) ...........................................................114
Figure 54 - Pre-use Test Error Message (07) ...........................................................115
Figure 55 -Pre-use Test Error Message (08) ............................................................115
Figure 56 - Absorber Not Fitted Message ................................................................116
Figure 57 - Set Absorber Message...........................................................................116
Figure 58 - Absorber Switch Set to VENT ................................................................117
Figure 59 - Absorber Switch Set to BAG ..................................................................117
Figure 60 - Standby Screen .....................................................................................118
Figure 61 - Fresh Gas Too High Screen (01) ...........................................................118
Figure 62 - Fresh Gas Too High Screen (02) ...........................................................118
Figure 63 - Fresh Gas Too High (03) ........................................................................119
Figure 64 - Fresh Gas Too High (04) ........................................................................119
Figure 65 - Fresh Gas Too High (05) ........................................................................119
Figure 66- A.C.G.O Screen ......................................................................................121
Figure 67 - Oxygen Screen ......................................................................................121
Figure 68 - Setup Menu............................................................................................122

16 BleaseSirius User Manual


List Of Figures
Figure 69 - Configuration Menu................................................................................122
Figure 70 - Measurements Menu .............................................................................122
Figure 71 - Adult & Pediatric Menu...........................................................................123
Figure 72 - A.C.G.O Port and SwitchLocations ........................................................123
Figure 73 - A.C.G.O Warning ...................................................................................123
Figure 74 - Adult Flow Sensor (L) and Pediatric Flow Sensor (R) ...........................124
Figure 75 - Standby Mode ........................................................................................125
Figure 76 - Sensor Placement Screen .....................................................................125
Figure 77 - Airway Sensor Placement - Sensor at Patient and Sensor at Absorber 127
Figure 78 - Waveform Select Options ......................................................................128
Figure 79 - Airway Pressure Bar ..............................................................................128
Figure 80 - Store Loop .............................................................................................128
Figure 81 - Current Loop & Saved Loop Display......................................................129
Figure 82 - Store Loop Options ................................................................................129
Figure 83 - PEEP Loop ............................................................................................130
Figure 84- Spontaneous Breathing Loop .................................................................130
Figure 85 - Bronchospasm Loop ..............................................................................130
Figure 86 - Kinked Tube Loop ..................................................................................130
Figure 87 - Patient Breathing with Vent (e.g. Lack of relaxation) Loop ....................130
Figure 88 - Cuff or Laryngeal mask Leak Loop and Kinked Tracheal Tube Loop ....130
Figure 89 - Intro-abdominal CO2 Insufflation Loop ..................................................131
Figure 90 - Pneumothorax Occurs Loop ..................................................................131
Figure 91- PEEP Treatment Loop ............................................................................131
Figure 92 - Zero Baseline .........................................................................................132
Figure 93 - Expired Flow from and Inspired Flow to Patient ....................................132
Figure 94 - Ventilation Mode Menu ..........................................................................133
Figure 95 - Change Ventilation Mode Prompts ........................................................133
Figure 96 - Pause Options .......................................................................................133
Figure 97 - Alarm Screen .........................................................................................135
Figure 98 - Auto Set Alarm Buttons ..........................................................................143
Figure 99 - Alarms Limits Options ............................................................................144
Figure 100 - Mute Time Options ...............................................................................145
Figure 101 - Setting Apnea Time ..............................................................................145
Figure 102 - PAW <-10cmH2O Option ......................................................................146
Figure 103 - Defaults Menu ......................................................................................146

BleaseSirius User Manual 17


List Of Figures
Figure 104 - Change Names Screen........................................................................148
Figure 105 - Save Current Settings Menu ................................................................149
Figure 106 - Change Password Option Selected .....................................................149
Figure 108 - Example System Information Screen, Page 1 .....................................150
Figure 107 - Configuration Menu..............................................................................150
Figure 109 - Installing the Bellows ...........................................................................157
Figure 110 - Compliance Prompt ..............................................................................159
Figure 111 - Removing the Pop-off Valve .................................................................163
Figure 112 - CAS I and CAS II Absorber Components.............................................185
Figure 113 - Absorber Flow Circuit ...........................................................................188
Figure 114 - Install the Absorber .............................................................................189
Figure 115 - Amsorb Seal .........................................................................................190
Figure 116 - Canister Seal Orientation Icon .............................................................191
Figure 117 - Center Seal Icon ..................................................................................191
Figure 118 - Absorber Upper Seal ............................................................................192
Figure 119 - Bag Arm Link Pipe ................................................................................192
Figure 120 - Connect the Breathing Circuit Tubing ..................................................193
Figure 121 - Large Upper Seal .................................................................................198
Figure 122 - Canister Seal Orientation Icon .............................................................198
Figure 123- Center Seal Icon ...................................................................................198
Figure 124 - Reinstall the APL Valve Past Two Notches ..........................................202
Figure 125 - Non-MRI Manometer ...........................................................................205

18 BleaseSirius User Manual


BleaseSirius
How to Use This Manual

This manual is designed as a guide for learning to operate the BleaseSirius


Anesthesia System, and also as a reference tool to use once you are familiar
with the system.

This manual has four sections: the first contains information about the
BleaseSirius Anesthesia Machine, the second describes the 700/900 Series
Ventilator, third discusses the CAS Absorber, and fourth lists Notices and
Important User Information.

BleaseSirius User Manual 19


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20 BleaseSirius User Manual


Section 1
BleaseSirius

BleaseSirius User Manual 21


Section 1 - BleaseSirius Anesthetic Machine

Symbols and Abbreviations Used


APL Airway Pressure Limiting IEC symbol for alternating current

Confers approval under the European


A.C.G.O Auxiliary Common Gas Outlet Medical Device Directive and the notified
body number
bpm BPM Breaths per minute End of Case

CAS Circle Absorber System Oxygen Flush

C.G.O Common Gas Outlet Pipeline


Gauge pressure expressed in centi-
cmH2O Cylinder
metres of water

CO2 Carbon Dioxide Bag

CPAP Continuous Positive Airway Pressure Canister unlocked

ECG Electrocardiogram Canister locked

Canister
Electrostatic Discharge/Electrostatic- Canister seal
Sensitive Devices Canister
ESD
hectoPascal. Gauge pressure ex- Federal law restricts this device for sale
hPa by or on the order of a physician.
pressed in hectopascals.

PEEP Positive and expiratory pressure Latex free material is used

I:E Ratio A ratio of inspiratory to expiratory time Exhaust

Caution: Attention, see instructions


Dangerous voltage
for use
IEC symbol denoting type B applied
Manufacturer
part
When this label is present, the machine
WARNING: There is danger of person- is fitted with isolation transformers that
al injury to the user or patient isolate the auxiliary socket outlets from
the machines mains supply
This symbol indicates that electrical
Further relevant or helpful information and electronic equipment waste must
not be disposed as unsorted municipal
waste and must be collected separately.
Turn the control on the direction of the Please contact an authorised representa-
thickening line to increase the setting tive of the manufacturer for information
and vice versa. concerning the decommissioning of your
equipment

Power Off This label identifies a socket that is


switched on an off with the main On/Off
Power On switch.

22 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

Vent Date of Manufacture

l/m lpm Litres per minute LED Light Emitting Diode

ml Millilitres PSV Pressure Support Ventilation

mV Millivolts TV Tidal Volume

N2 O Nitrous Oxide psig Pounds per square inch gauge

Pedi Sensor Pediatric Sensor


Spirometry/Sensor
Pplat Plateau Pressure

O2 Oxygen l or L Liters

psi Pounds per Square Inch LCD Liquid Crystal Display

Manometer Serial number

Alarm Alarm Muted

Caution Oxygen sensor port

Absorber Bypass Absorber ON

This way up Ptot Total Pressure Set including PEEP

Synchronised Intermittent Mandatory Synchronised Intermittent Mandatory


SIMV-VC + SIMV-PC +
Ventilation-Volume Control + Pres- Ventilation-Pressure Control + Pres-
PSV PSV
sure Support Ventilation sure Support Ventilation

EFM Electronic Flowmeter EFM Total Failure Alert

BleaseSirius User Manual 23


Notes

24 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.1 Introduction

This manual describes the different components of the BleaseSirius Anesthetic


Machine. It also provides instructions explaining how to install, set up, operate
and maintain this machine.

For safety reasons, be sure to read the Warnings and Cautions in Section 4 of
this manual and any that appear throughout.

Before you set up or operate this machine, familiarize yourself with the
BleaseSirius Anesthesia System by reading through this entire manual and the
machines associated documentation. Also read the manuals for any optional
monitors and accessories that are installed in the system.

Any adaptation, modification or procedure not recommended by Spacelabs


Healthcare or their agents may affect any warranty relating to the machine.

Requests for advice, assistance or servicing facilities should be addressed to


Spacelabs Healthcare or an authorized Spacelabs Healthcare agent.

Read the Responsibilities of the User and Responsibilities of the Manufacturer


statements listed in Section 4 of this manual. These statements assign
responsibility in case of a functional defect.

Keep this manual with the system as a reference for any questions that
arise about the systems operation, maintenance or, if necessary, repair.

All pictures shown in this manual are of the BleaseSirius machine.


Note that not all options available for the BleaseSirius are shown in this
manual.

The BleaseSirius is latex free. Note that any replacement parts must not
contain latex.

BleaseSirius User Manual 25


Section 1 - BleaseSirius Anesthetic Machine

Electrostatic Sensitive Devices

All ESD must be stored in approved conductive packaging, DIP tubes, shipping
bags, foam or tote bins.

All persons handling ESD must be properly grounded via a 1mW resistive
grounded wrist strap.

Cover all ESD bench tops with grounded conductive mats and connect all work
surfaces and equipment to earth ground.

Transport all assemblies containing ESD in a conductive bag or container.

Do not use cellophane adhesive tape to wrap DIP (dual in-line package) tubes
together.

DO NOT handle ESD by their pins or mix them with other routine electronic
parts.

Never place ESD on ungrounded surfaces or leave them unattended in an open


area.

Avoid contact with cellophane wrappers, synthetic (non-conductive)


carpeting, warm or cool air blasts, styrofoam coffee cups, etc when
working with ESD.

Use only properly designed heat lamps, heat chambers and/or antistatic
quick-chill sprays during troubleshooting or stress testing procedures.

In particular electronic assemblies in the BleaseSirius range of machines


are easily damaged by ESD and require special handling.

26 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.2 Description
1.2.1 General
The BleaseSirius anesthesia machines contain all the pneumatic circuitry,
controls, monitoring, ancillaries and storage required to control, distribute and
mix medical gases and anesthetic agents in order to deliver them to a patient
system. Figure 1 on the next page identifies the major system components.

The BleaseSirius anesthetic machine is designed to comply with the following:

ASTM F-1850
UL 60601-1
ISO 5358, IEC 60601-1
IEC 60601-2-13
BS EN 740 and other International Standards.

The references made to sterilization within this manual do not indicate that the
anesthesia machine and its components are sterile as supplied or are required
to be sterile for their operation.

The following equipment is mandatory. Please refer to the appropriate


user manuals for instructions on using the blood oxygen monitor,
CO2 alarm, blood pressure alarm, ECG alarm and anesthesia agent
concentration.

This machine is to be equipped with an anesthetic gas scavenging


transfer and receiving system, complying with ISO 8835-3 or applicable
local standard before being put into service.

If the integrated oxygen monitor is not installed, an oxygen monitor


complying with ISO 7767 shall be used when the anesthetic machine is
used.

A CO2 monitor complying with ISO 9918 shall be used when the
anesthetic machine is in use.

Adult breathing circuits with the anesthetic machines shall comply with
ISO 8835-2.

BleaseSirius User Manual 27


Section 1 - BleaseSirius Anesthetic Machine

T
S
A

R B

Q C

O
N G
H

L I

J
K

Figure 1 - BleaseSirius Anesthetic Machine

28 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

Figure 1 Key
A Monitor Shelf
B Ventilator
C Vaporizer
D Cylinder/Pipeline Gauges
E Pneumatic Unit - (behind gauge panel)
F Handle
G Oxygen Flush
H Common Gas Outlet (or option A.C.G.O.)
I Drawer
J Frame
K Brake Pedal
L A.G.S.S.
M Absorber
N Bag Arm Link Pipe
O Adjustable Bag Arm
P Suction Controller
Q Main On/Off Switch
R Flow Control Valves with Hypoxic Guard
S Mechanical Flowblock Assembly (pictured) or
(or optional Electronic Flowmeter)
T Auxiliary Flowmeter

BleaseSirius User Manual 29


Section 1 - BleaseSirius Anesthetic Machine

C
E

Figure 2 - Back of BleaseSirius

Figure 2 Key
A Electrical Socket Bank
B Electrical On/Off Switch
C Pipeline Inlets
D Circuit Breakers
E Cylinder Yokes
F Cable and Pipeline Strap Fixing

30 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.2.2 The Frame


The steel frame is covered by moldings with a painted finish. It is supported
on a cast aluminum base with four castors, with a brake pedal at the bottom of
the trolley.

1.2.3 Pneumatic Assembly


The frame contains the pneumatic assembly. The pneumatic unit contains
the gas supply inputs, the pneumatics that regulate the supply pressures to a
usable pressure, the oxygen failure alarm and its logic circuitry, the common
gas outlet, the user controls and the pneumatic power outlets. Above the work
surface are the cylinder contents and pipeline pressure gauges, flow control
valves, hypoxic guard and flowblock assemblies, the vaporizer back bar and
the uprights, which support the monitor shelf.

1.2.4 The Monitor Shelf


The monitor shelf (A in Figure 1), is mounted on top of the machine. Loading
on this shelf should not exceed 25 kg/55.1 lbs.

In the U.S.A., use a cord fitted with a NEMA 5-15 hospital grade plug to
connect the BleaseSirius to the mains power supply.

Connection of equipment to the auxiliary mains socket outlets may


increase leakage currents to values exceeding the allowable limits.

Connection of the equipment to the socket outlets will increase leakage


currents. It is the users responsibility to ensure compliance to IEC 60601-
1-1 (collateral standard for electrical medical systems). In the USA,
equipment connected to the socket outlets must comply with UL 60601-1
and the total sum of the system leakage current shall not exceed 300
micro amps. It is the USERs responsibility to ensure compliance with the
above standard and that the leakage current limits are not exceeded.

BleaseSirius User Manual 31


Section 1 - BleaseSirius Anesthetic Machine

1.3 Specification
1.3.1 Physical
1.3.1.1 Machine Dimensions
Height Maximum Width Depth Average Weight
1486 mm/58.5 inches 705 mm/27.7 inches 747 mm/29 inches 110 kg/242.5 lbs

1.3.1.2 Work Surface Dimensions


Height Area
854 mm/33.6 inches 98612.2 mm2/152.8 in2

1.3.1.3 Monitor Shelf Dimensions


Height Area
1486 mm/58.5 inches 175,833 mm2/272.54 in2

1.3.2 Maximum Loading


Area Maximum Weight
Monitor shelf 25 kg/55.1 lbs, evenly distributed
Work surface 25 kg/55.1 lbs, evenly distributed
Bottom Shelf 8 kg/17.6 lbs, evenly distributed
Drawers 5 kg/11.0 lbs, evenly distributed
Extended Work Surface 15 kg/33.0 lbs, evenly distributed
(intermittent or occasional loading only)

Gross loading = 250 kg/551.1 lbs

Connect this equipment only to gas pipeline supply lines that are fitted
with pressure relief valves that limit the supply pressure to less than 700
kPa/max, (101.5 psi/max).

Secure any equipment placed on shelves.


Overloading may cause damage to the shelves or cause instability.

32 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.3.3 Pneumatics
1.3.3.1 Gas-Specific Color Specifications
Gas Color (ISO Countries) Color (ANSI Countries)
Oxygen White Green
Nitrous Oxide Blue Blue
Medical Air Black Yellow

1.3.3.2 Electrical Cable Color Specifications


Cable Color (230V Machines) Color (110V Machines)
Neutral Blue White
Live Brown Black
Earth Yellow/Green Green

1.3.3.3 Miscellaneous
Item Maximum
Number of Gases 3
Number of Cylinders 4
Number of Pipelines 3
Number of Gauges 7
Cylinder Size E

1.3.3.4 Common Gas Outlet


The common gas outlet is located on the front of the machine below the work
surface. It will accept a 22 mm female or a 15 mm male taper coupling.

BleaseSirius User Manual 33


Section 1 - BleaseSirius Anesthetic Machine

1.3.4 Technical/Performance Specifications


1.3.4.1 Controls

Mechanical Flow Meter Specification


Oxygen Flow 150 20 ml/m to 10 l/m
Simplex/Cascade
Nitrous Oxide Flow 0 ml/m to 12 l/m Simplex/Cascade
Medical Air Flow 0 ml/m to 15 l/m
Flowblock Assembly Accuracy 5% measured value at 20C and
101.3 kPa/14.6 psi

Control Specification
Oxygen Flush Non-locking 45 to 55 l/m for inlet pres-
sures 45 psi to 60 psi
Vaporizers Accepts Selectatec
Hypoxic Gases Minimum 21% oxygen/nitrous oxide
mixture allowed

If you have the Electronic Flowmeter, see Section 1.5.5.2.2 in this manual
for the technical specifications for that option.

1.3.4.2 Ventilator
Depending on the system configuration, a 700- or 900-series ventilator is inte-
grated into the BleaseSirius.

The units of pressure measurement are cmH2O or hPa.

The BleaseSirius machine is not suitable for use in an MRI environment.

34 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.3.4.3 Alarms/Indicators
Oxygen Failure Audible alarm for minimum of 8 secs, when oxygen
pressure falls below 225 kPa/32.6 psi.

1.3.4.4 Regulator Safety Valve Settings


Cylinder Regulator 310.3kPa/45psi
Cylinder Regulator Relief Valve 500kPa/72.5psi
Machine Gas Piping Design Rating 700kPa/max. 101.5psi
Secondary Hypoxic Regulators 25-32psi O2
25-35psi N2O } 0.5Lpm flow

Common Gas Outlet Relief Valve 27.6-34.5kPa/3-4psi

1.3.4.5 Electrical Specifications


Voltage 110 V 230 V
Frequency 60 Hz 50 Hz
Power 1.2 kVa 1.0 kVa

The auxiliary sockets are numbered 1 through 4, from top to bottom and
are rated as shown in the following tables. If the machine has the switching
sockets option, sockets 3 and 4 will switch On and Off when the Main system
On/Off (Figure 1, P) is switched On and Off, not the electrical On/Off switch
(Figure 3, B).
Electrical labeling is shown on the next page.
230V 110V
Socket Outlet Rating Breaker Fuse Socket Outlet Rating Breaker Fuse
1 2A 3A 4A 1-4 2A 3A 4A
2-4 1A 2A 3.15A

Connection of the equipment to the socket outlets will increase leakage


currents. It is the users responsibility to ensure compliance to IEC
60601-1-1 (collateral standard for electrical medical systems). In the USA,
equipment connected to the socket outlets must comply with UL 60601-
1 and the total sum of the system leakage current shall not exceed 300
micro amps. It is the USERs responsibility to ensure compliance with
the above standard and that the leakage current limits are not exceeded.

BleaseSirius User Manual 35


Section 1 - BleaseSirius Anesthetic Machine

1.3.4.5.1 Electrical Labeling


A

B Figure 3 Key
A Switched Outlet Label
B Isolation Transformer
Label

Figure 3 - Electrical
Labeling

The units use semiconductor devices which are susceptible to damage


by overloading, reversed polarity, electrostatic discharge and excessive
heat or radiation. Avoid hazards such as reversal of batteries, prolonged
soldering, strong RF fields, or other forms of radiation, use of insulation
testers or accidentally applied short circuits. Even the leakage current
from an unearthed soldering iron may cause trouble.

1.3.4.6 Gas Flows


O2, MED AIR, N2O Pipeline Nominal pressure 400 kPa/58.0 psi,
minimum 275 kPa/39.8 psi, maximum
482 kPa/69.9 psi
Auxiliary Pneumatic Outlets MED AIR or O2 - 400 kPa/58.0 psi at zero
flow. 80 l/m max. flow
Auxiliary Oxygen Outlet 0-15 lpm

1.3.4.7 Environmental Conditions


Operating Temperature 5C to 40C (41F to104F)
Oxygen cell operates to specification 10C to
40C (50F to 104F)
Storage Temperature -20C-60C (-4F-140F) with oxygen cell
removed
0C-50C (32F-122F) with oxygen cell in
place
Humidity 15-95% Non-condensing

36 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.3.5 Ancillary and Optional Features


Standard Features
Integrated 700/900 Series Ventilator
2-Position Selectatec Backbar
Simplex Single Tube Mechanical Flowmeter (O2), with Backlighting
O2 Pipeline Inlet Fitting
Integrated Suction Regulator
CO2 Circle Absorber, without CO2 Bypass, Double or Single Canister
Overhead Monitoring Shelf with Strap
Up to 7 Gauges for Cylinders and Pipelines
Common Gas Outlet
Vaporizer Illuminated Da-Lites
Work Surface Illumination Light
Right & Left GCX Rail
Side Mounted Grab Rails
Emergency O2 Flush
Single Integrated Footbrake
Work Surface Mat
4 x Electrical Sockets
2 x Female V Brackets
Adult Patient Y Circuit (Disposable)
BleaseSirius User Manual

BleaseSirius User Manual 37


Section 1 - BleaseSirius Anesthetic Machine

Required Features

Air and/or N2O pipeline fittings (Note: If the system has the electronic
flowmeter, it can have 2-gas fittings, O2 and Air)
Anesthetic Gas Scavenging System
Drawer Options
Market Specific Localization

Optional Features

Electronic Flowmeter (EFM)


Cascade Flowmeter (unless EFM is specified)
Up to 4 Cylinder Yokes
Air or O2 High Pressure Outlet
Folding Side Shelf
CO2 Bypass
Absorber Bag Arm
Auxiliary O2 Flowmeter
Auxiliary Common Gas Outlet
Electrical Isolation Transformer
Switched Electrical Outlets
Gas Supply Hoses
Vaporizers
Suction Jars
Circuits, Masks, Connectors
Large Cylinder Kit
Pendant Mount

38 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.3.5.1 Vaporizers

Datum Vaporizers with Standard Fillers Part Number


Selectatec Mounting
Halothane calibrated to 5% v/v 13022218
Enflurane calibrated to 5% v/v 13032218
Isoflurane calibrated to 5% v/v 13012218
Sevoflurane calibrated to +8% v/v 13062218

Datum Vaporizers Key-Fill Selectatec Part Number


Mounting
Halothane calibrated to 5% v/v 13022118
Enflurane calibrated to 5% v/v 13032118
Isoflurane calibrated to 5% v/v 13012118
Sevoflurane calibrated to +8% v/v 13062118

BleaseSirius User Manual 39


Section 1 - BleaseSirius Anesthetic Machine

1.4 Installation
Upon delivery, inspect the system and its accessories for any damage that
may have occurred during shipment. If you find any damage, immediately
notify the transportation company and file a damage claim. Save the original
shipping container, packaging, materials and any manuals or instructions.

Many of the installation steps given in the following sections are performed
by a Spacelabs Healthcare service representative. However, you may need
to disconenct/reconnect certain components during use, maintenance or
sterilization. Always verify that the system is properly setup any time you
disconnect, then reconnect components.

1.4.1 Install the Cylinders


Refer to Figure 4a as you perform the following steps.
1. Unpack the cylinders from the shipping container.
2. On the back of the machine, open a yoke by turning the bridge piece
counter-clockwise.
3. Ensure that the cylinder gasket is installed on the cylinder/yoke connector
and is clean and undamaged.
4. When fitting a new cylinder, ensure that its seal and cap are undamaged.
5. Remove the seal and cap from the cylinder and discard.
6. Using a non-ratchet cylinder key, open the cylinder. As soon as gas issues
from the cylinder, close the cylinder again.
The cylinder should be primed, as described in step 6, to ensure that
no foreign material enters the yoke when the cylinder is opened on a
machine.

7. Verify that the pin indexing on the cylinder valve corresponds to that in the
cylinder yoke on the machine.
8. Align the cylinder connection with the corresponding connection in the
cylinder yoke. Position the valve in the opening in the yoke.
Do not leave gas cylinder valves open if the pipeline supply is in use and
the system master switch is turned ON. Pressures from both supplies
may become equal and, if simultaneously used, cylinder supplies could
become depleted, leaving an insufficient reserve supply in case of
pipeline failure.

40 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

Figure 4a Key
A Cylinder
B Yoke
C Locking Handle
D Bridge

Figure 4a - Installing the Cylinders

Figure 4b Key
A Inlets
B Securing Straps
C Securing Chains
D Large Cylinder Tray

Figure 4b - Installing Large Cylinders

BleaseSirius User Manual 41


Section 1 - BleaseSirius Anesthetic Machine

9. Align the yokes connector and pins with the corresponding holes in the
cylinder valve, then push the cylinder into the opening of the yoke so that
the connector is fully engaged.
10. While supporting the cylinder from underneath, close the cylinder yoke. by
turning the bridge clockwise until its cutout is fully engaged in the coupling
on the yoke body.
11. Secure the cylinder by turning the T-screw clockwise so that the screw
engages with the location in the cylinder valve. Tighten the screw until the
cylinder is firmly secured against the connecting face of the yoke.
12. Repeat steps 1 through 10 to install the remaining cylinder(s) on the
machine.
Always keep the cylinder valves shut when not in use to prevent leakage
from the cylinder valve gland nut.

Do not use wrenches on the yoke bridge T-screw to avoid stripping the
threads. Use only one cylinder gasket per yoke. Using more than one
gasket could cause cylinder gas leakage.

1.4.1.1 Install the Large Cylinders (Optional)


It is important to follow guidelines with regard to handling of large cylinders
as per local/regional regulations. Refer to Figure 4b as you install the large
cylinders.
1. With cylinder resting on platform at rear of machine, attach chain and
secure at the side. Clip straps together and pull to ensure that it is secure.
2. Make sure appropriate regulator has been installed and tested as per
manufacturers guidelines.
3. Connect appropriate hoses to secondary gas inlets.
4. If you have the optional vaporizer parking block, install it on the rail on the
left side of the back of the machine.

The input to the machine pipelines should be regulated to 275-482 kPa


(40-70 psi). To ensure the cylinder supply is only used as a backup,
regulate the pressure to a lower pressure than primary pipeline.

When maneuvering machine with large cylinders attached, remove any


items from the monitor shelf and/or the vaporizer parking block.

42 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.4.2 Connect the Pipelines


1. Remove and discard the protective caps from the pipeline inlets.
2. Ensure that each pipeline (O2, N2O, MED AIR and scavenging and
suction) is coupled to the appropriate inlet by noting which gas is marked
on the inlet.
The pipeline connections are not interchangeable, as they are fitted with
gas-specific male NIST connectors (male DISS on U.S. machines, female
DISS on Canadian machines and SIS on Australian machines).
3. Align the pipelines probe with the corresponding inlet coupling.
4. Push the probe into the coupling until the threaded section engages with
the thread on the connector.
5. Secure the connector by rotating the locking ring fully clockwise (gas inlet
fitting should be attached securely to ensure it is leak tight).
6. Repeat for all the required pipeline supplies.
7. Plug the pipelines into suitable outlet points.

1.4.3 Connect the Oxygen Transducer


Refer to Figure 5 as you connect the oxygen sensor to the machine.
1. Connect one end of the curly oxygen sensor cable to the back of the
oxygen sensor.
2. Connect the other end of the curly oxygen sensor cable to the pneumatic
unit under the workspace on the left side of the machine. This connector
is labelled

3. Plug the oxygen sensor into the socket on the front of the absorber.

The oxygen monitor requires at least 10 minutes to stabilize after it has


been turned on. The transducer should always remain plugged into the
machine to ensure that it is ready for use.

The oxygen sensor measures the concentration of oxygen in the patient


circuit.

BleaseSirius User Manual 43


Section 1 - BleaseSirius Anesthetic Machine

Step 1 Step 2

Step 3

Figure 5 - Connect the Oxygen Sensor

44 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.4.3.1 Guidelines for Handling the Oxygen Sensor


1. Do not expose the sensor to gas samples at a temperature that exceeds
the limits listed in section 1.3.4.7.
2. In general, there are no altitude restrictions for sensor installation.
However, for optimal performance and life characteristics, it is
recommended that the sensor be mounted with the sensing surface
oriented in a horizontal position. Normally, it will be inserted in the
absorber.
3. Take precautions to prevent condensation forming on the sensor surface.
4. Do not subject the sensor to excessive shock or vibration. In general, do
not expose the sensor to shock greater than 2.7G.

Never disassemble or modify the oxygen sensor.

1.4.4 Install the Selectatec Vaporizers


You can fit a maximum of two vaporizers to the BleaseSirius backbar manifold.

1. Remove the protective caps from the inlet ports on the vaporizer. Discard
the caps.
2. Check that the O rings on the connectors on the backbar manifold are
present and undamaged (replace the O rings, if necessary).
3. Ensure that there is no foreign matter present on the mainfold and
vaporizer connectors.
4. Turn the vaporizer locking lever fully counter-clockwise.
5. Turn the vaporizer concentration setting control fully clockwise to off.
6. Position the vaporizer on to the backbar manifold so the manifold ports
align with the vaporizer ports.
7. Push the vaporizer down on to the backbar manifold and secure in
position by turning the locking lever fully clockwise.

Refer to the vaporizer operating manual for filling and operating


instructions.

8. Perform the Leak Test (refer to Section 1.9.1 Leak Test).

BleaseSirius User Manual 45


Section 1 - BleaseSirius Anesthetic Machine

Vaporizer Warnings

Refer to the vaporizer operating manual before use, for filling, operating and
service instructions. The manual also contains information concerning the
extent to which the delivered vapor concentration is affected by changes in
ambient temperature and pressure, and accuracy and calibration details, which
should be understood before use. Vaporizers should not be used when set
between the OFF position (or the ZERO position, if this is also the OFF position)
and the first graduation mark.

Do not use any vaporizer that is visibly misaligned on the manifold or that, when
it is locked, can be lifted off the manifold. Incorrect mounting may result in
incorrect delivery of gases.

A vaporizer is calibrated and labeled for one agent only. Do not fill with anything
other than the designated agent. If a vaporizer is filled with the wrong agent,
draining will not eliminate the agent, because the wick will have absorbed some
of the agent. The wick must be thoroughly cleaned and dried by approved
technical engineers.

The vaporizers must be completely upright for the sight glass to properly
indicate agent levels.

Never oil or grease any oxygen equipment unless the lubricant is made
and approved for this type of service. In general, oils and greases oxidize
readily, and - in the presence of oxygen - will burn violently. Fomblin is the
recommended oxygen service lubricant.

After performing any maintenance or repair procedure, always verify proper


operation of the system before returning to use.

Use cleaning solution sparingly. Do not saturate the system components.


Excessive solution can damage internal devices.

Following ethylene oxide sterilization, quarantine the vaporizer(s) in a well


ventilated area to allow dissipation of absorbed ethylene oxide gas. In some
cases, aeration periods of seven days or more may be required. Aeration time
can be decreased when special aeration devices are used. Follow the sterilizer
manufacturers recommendations for aeration periods required.

46 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

Maintain sufficient fresh gas flow when using sevoflurane.

To remove a vaporizer from the backbar:

1. Position the vaporizer control dial to Off.


2. Turn the vaporizer locking lever fully counter-clockwise to release the
vaporizer.
3. Carefully lift the vaporizer straight up and off the manifold.

BleaseSirius User Manual 47


Section 1 - BleaseSirius Anesthetic Machine

N
L A M O

K
J

I B
C
H
G D
F E

Figure 6 Key
A APL Valve
B Bypass Switch (optional) (not available in the
USA)
C Expiratory Non-return Valve
D Canister
E Bag Arm Link Pipe [Bag Port] (Optional)
F Patient Expiratory Connector (22 mm male and
15 mm female taper)
G Oxygen Sensor Port and Oxygen Sensor Port
Blanking Plug
H Patient Inspiratory Connector (22mm/0.8 male
and 15mm/0.5 female taper)
I Bag Arm and Port (optional)
J Inspiratory Non-return Valve
K Bag/Vent Switch
L Manometer Gauge
M Fresh Gas Port
N APL Exhaust Port
O Vent Port
Figure 6 - CAS Absorber and Components

48 BleaseSirius User Manual


Section 1 - BleaseSirius Anesthetic Machine

1.4.5 Install the CAS Absorber


The absorber is supported on a two-prong assembly,
which is mounted on the left side of the machine.

1. Align the mounting holes on the back of the


absorber with the horizontal prongs on the left side
of the BleaseSirius (Figure 7).
2. Slide the absorber into place. You will hear a click
when the absorber is properly seated.
Figure 7 - CAS Absorber
3. Attach a patient breathing bag to the absorber. Mounting Brackets

BleaseSirius User Manual 49


Section 1 - BleaseSirius Anesthetic Machine

1.4.6 Install the Extended Work Surface (Optional)


The extended work surface for the BleaseSirius is must be installed on site by
a qualified Technical Engineer.
Only qualified Technical Engineers are authorized to fit the extended
work surface assembly.

To open the extended work surface:


1. Lift the work surface so that it is just above normal
horizontal position.
2. You will hear a click that indicates the mechanism
has locked in place (Figure 8).

To close the extended work surface: Figure 8 - Extended Work


Surface Open
1. Lift the work surface slightly upward.
2. Place your hands as shown in Figure 9 and
squeeze to release the locking mechanism.
3. Gently lower the surface into place. The extended
work surface is shown in the closed position in
Figure 10.
Figure 9 - Extended Work
Surface Operation

Figure 10 - Extended
Work Surface Closed

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1.4.7 Patient Airway Flow Sensor


The adult sensor is shown in the following sections for instructional
purposes. The Pedi Sensor is set up in the same manner
Flow Sensor Tubing
Sample tube can be retained
with patient airway flow sensor
connection part.

Patient Airway Flow Sensor

White Cap

Gas Monitor Sample Line

Figure 11 - Patient Airway Flow Sensor

Remove the white cap from side of patient sensor and screw the luer
connection onto the end of the gas sample line.

The pedi sensor does not have a capnography port. It is recommended


that you connect your CO2 analyzer via the HMEF or a separate
connector.

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Section 1 - BleaseSirius Anesthetic Machine

If the gas sample line is not in use, then replace white cap. The Pedi
Sensor does not have a gas sampling port.

The machine is to be equipped with an anesthetic gas scavenging


system, complying with ISO 8835-3 or applicable local standard before
being put into service.

The patient airway flow sensor must be correctly installed at either the
distal location in the patient systems expiratory limb or the proximal end
of the Y connector. If the sensor is installed incorrectly, volume data will
be inaccurate and associated alarms, including the low minute volume
alarm will not function properly.

Position the patient airway flow sensor tubing with care. If the tubing
is pinched or cut, the ventilators volume monitoring may not function
properly.

Check the flow sensor tubing regularly for trapped water, as it could
affect ventilator readings.

1.4.7.1 Filter
A patient filter is recommended, but not essential since all parts of the
patient circuit may be sterilized.

Incorrect and correct ways of setting up the breathing circuit with filter
are shown in Figures 12a and 12b on the next page. Ensure that the
sensor is not contaminated by moisture and the patient circuit does not
produce a jetting effect onto sensor.

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Pic. 1: This setup is


INCORRECT. The small Sensor
diameter tubing of the patient
circuit can cause jetting to front
port of the flow sensor. This will To patient
lead to exceptionally high VTE To absorber
HME Filter
readings. Pic.1

Sensor HME Filter


Pic. 2: This setup is correct,
but could be improved by
expanding the extension tube
as shown in Pic. 3. To absorber To patient

Pic.2

Figure 12a - Filter Set Up

Sensor
PREFERRED ways of connecting the HME Filter
patient circuits are shown below (Pics 3,
To absorber
4, 5 and 6).

Pic.3 To patient

Pic.4 Pic.6

Pic.5

Figure 12b - Filter Set Up

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Section 1 - BleaseSirius Anesthetic Machine

1.4.8 Suction Controller Mode Switch

1.4.8.1 Fitting the Suction Controller


The suction system consists of a suction controller and a
receiver jar. The suction controller is built into the trolley on
the upper left corner of the machine, behind the bellows.
The receiver jar is mounted on the left hand wall and fits
into a bracket (straight bracket for USA, V bracket for all
other countries) on the lower left side.
1. Using a high vacuum type, plug the controller vacuum
connection (situated on the lower rear left hand corner
of the trolley) into a suitable vacuum source.
2. Align the receiver jar mounting with the bracket and
push the receiver jar downwards so that the jar is fully Figure 13 - Suction
engaged into bracket. Controller
3. Connect the pipe and online filter to the receiver jar.
Note that there is no locking or securing mechanism for the suction controller.
FEATURE MODE HIGH VAC.
Selector Switch FULL YES
Modes Available REG YES
OFF YES
Regulated Vacuum REG Maximum Available
Range (+/- 10mmHg) FULL Maximum Available
Maximum Flow REG 80 LPM**
Regulator Only
(Nominal)
Safety Relief Valves REG None
Source Vacuum Range 12 to 30inHg (305 to 762mmHg)
Unit Calibrated at 18inHg Vacuum Source
Overall Dimensions 174mm/6.8 High x 67mm/2.6 Wide x 152mm/5.9 Deep
Weight 1.3lbs. (0.59 kg)
Vacuum Gauge:
Range 0 to 760mmHg (Increments of 25mmHg) 0 to 101kPa/14.6psi (increments of
5kPa/0.7psi)
Size 2 in Diameter Gauge Face
Type Diaphragm
Materials of Construction:
Case High Impact Polycarbonate
Knobs Soft Thermo Plastic Rubber Outer Shell Molded on Thermoplastic body

Internal Parts Brass, Stainless Steel and Plated Steel


Operating Temperatures 5oC to 32oC
Operating Humidity 25% to 95% RH non-condensing

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1.4.8.2 Suction Controller Features


**Maximum flow is affected by vacuum source and fittings.

1.4.8.3 Testing the Suction System


After installing the suction system, perform a simple adjustment and test:
In the Continuous Mode:
1. Turn the Mode switch to REG.
2. Occlude the hose attached to the patient connection of the collection
bottle.
3. Wait for the vacuum reading on the gauge to rise and stabilize, then
adjust the High Flow dial to the maximum desired level.
4. Remove the occlusion.
In the Full Mode:
1. Turn the Mode switch to FULL.
2. Occlude the hose connected to the output port of the regulator and verify
that the gauge reads full available vacuum.
3. Remove the occlusion.
4. Verify that the high flow suction exists.

1.4.8.4 Cleaning
Follow the directions given on the receiver jar to clean it.

1.4.9 Installing Ancillary Equipment (optional)


Ancillary equipment which may need pneumatic power or an oxygen
supply (ventilators, saws, etc) should have their supply hoses plugged into
the pneumatic outlets at the back of the machine. All machines have high
pressure oxygen power outlet. One optional additional pneumatic power outlet
is available for either MED AIR or oxygen. This outlet is located on the right
side of the machine, above the side rail.
The Oxygen/MED AIR power outlets are not switched on or off by the
machines On/Off switch.
The equipment hose should be either a DISS nut (ANSI machines) or
a mini-Schrader probe (ISO). The mini-Schrader probe port is self-locking and
will hold the equipment probe in position.

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T A

B
S
R
Q C

P
D

F
O
G
N H

M I

Figure 14 - BleaseSirius Anesthetic Machine Components

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Figure 14 Key
A Monitor Shelf
B Ventilator
C Vaporizer
D Cylinder/Pipeline Gauges
E Pneumatic Unit - (behind gauge panel)
F Handle
G Oxygen Flush
H Common Gas Outlet (or option A.C.G.O)
I Drawer
J Frame
K Brake Pedal
L A.G.S.S.
M Absorber
N Bag Arm Link Pipe
O Adjustable Bag Arm
P Suction Controller
Q Main On/Off Switch
R Flow Control Valves with Hypoxic Guard
S Mechanical Flowblock Assembly(or optional
Electronic Flowmeter, if installed)
T Auxiliary Flowmeter

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1.4.10 Ventilators
See Section 2: 700/900 Series Ventilators in this manual for information on
your ventilator.

1.4.11 Post-Installation Check


When the system has been installed, perform the full system check. See
Section 1.9 Full System Test for details.

1.5 Theory of Operation


Upon receipt of new machines, you should sterilize/clean all
components of the BleaseSirius anesthesia machine before use.

Refer to Figure 14 on page 56 as you read this section.


The gas supply inputs consist of the pipeline inlets and cylinder yokes, that
couple and secure the gas cylinders to the machine, and its pneumatics. All
the gas input connections are gas-specific, the cylinder yokes are pin-indexed
and the pipeline inlets are non-interchangeable screw threads (NIST or DISS
on USA-specification machines).

The pneumatics that regulate the gas supply pressures consist of high
pressure regulators to reduce the cylinder gas pressures and non-return
valves to ensure that gases do not flow from one inlet to another. Each
cylinder yoke and pipeline inlet has an associated pressure gauge located at
the rear of the work surface. The cylinder-contents gauges are mounted on
the right side and the pipeline pressure gauges on the left side. The sequence
of the cylinder gauges is the same as that of the cylinder yokes.

The regulated gases are coupled to their flow control valves (R in Figure 14)
via the oxygen failure warning device.

The oxygen failure warning device monitors the pressure of the oxygen supply.
If the oxygen supply pressure falls below (225kPa/32.6psi), nitrous oxide is cut
off and the pneumatic audible alarm are activated.
If the oxygen supply fails, the nitrous oxide shuts off and an Oxygen
Failure Alarm sounds. The ventilator is also supplied with MED AIR
as an emergency driving gas. Restoration of the oxygen supply will
automatically return gases to their default settings.

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The gases flow from the pneumatic valves through the flow control valves and
their flowblock assemblies. Each gas has an associated flow control valve
and flowblock assembly. Turn the flow control valve dials counter-clockwise to
increase the gas flow and clockwise to reduce it.

The equipment must be periodically checked and maintained to ensure


proper operation.

The mechanical flow tubes are illuminated using a diffused back-lighting


system. The back light default setting is ON. You can turn the backlight
OFF in the Ventilator Software. (See Section 1.5.5.9 for instructions.)) In
addition to the back light, there is a work surface light. These lights are linked.
Turning off the backlight will also turn off the work surface light.

If you have the electronic flow meter (EFM) option, the backlight feature is not
available. For the EFM, the work surface light is always on.

All the gases can be turned off by turning the dials fully clockwise, except for
the oxygen control which has a minimum (basal) flow of 150 ml/min 20 ml/
min to 170 ml/min and the O2 flowmeter. To turn off the oxygen, the On/Off
switch (P) at the front of the machine must be used.

The valves are independent of each other except for the mechanical hypoxic
guard which links the oxygen and nitrous oxide flow controls together such
that the ratio of oxygen to nitrous oxide is not less than 25%.

Gases flow from the flow control valves to the vaporizers (if installed) at C
and then to the common gas outlet (H) located on the front edge of the work
surface. The common gas outlet is a male 22mm/15mm female taper.

The oxygen flush control (G) is located on the front of the work surface and
connects the regulated or pipeline oxygen supply directly to the common gas
outlet when it is operated. The control is pressed in to supply oxygen. The
oxygen flush is non-locking.

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The On/Off switch (P) is located on the front of the flowblock assembly and is
used to turn all the gases of the machine on or off (except the supply to the
oxygen flush control and the oxygen/air power outlet). The switch is turned
clockwise to turn the machine on and counter-clockwise to turn it off.

To minimize the possibility of exhausting the oxygen supply cylinders


and reduce unecessary waste, it is recommended that you switch off the
machine when it is not in use.

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1.5.1 C.G.O. Pressure Relief Valve


The machine is equipped with various pressure limiting devices to protect both
the patient and the user.

The C.G.O. is set between 3 and 4 psi/27.6 to 34.5 kPa.


The patient drive pressure is 75 cmH2O 2 cmH2O.
The individual gas cylinder regulators are set at 500 kPa/72.5 psi.

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Figure 15 - Pneumatic Circuit for the Mechanical Flowmeter

Figure 15 Key
A Air Pipeline
B Air Cylinder Yoke
C N2O Pipeline
D N2O Cylinder Yoke
E O2 Pipeline
F O2 Cylinder Yoke
G O2 Failure Alarm Valve
H Reservoir
I O2 Failure Whistle

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Figure 15 Key
J Air Takeover Valve
K N2O Cutoff Valve
L O2 Failure Alarm Switch
M On/Off Switch
N Vent Supply
O Air Secondary Regulator
P N2O Secondary Regulator
Q Oxygen Secondary Regulator
R Oxygen Flush
S Air Flowmeter or Air Flow Sensor (on
EFM)
T N2O Flowmeter or N2O Flow Sensor
(on EFM)
U Hypoxic Protection Link System
V Oxygen Flowmeter or Oxygen Flow
Sensor (on EFM)
W Vaporizer Backbar
X C.G.O. or A.C.G.O.
Y Relief Valve
Z Fresh Gas Flow Sensor
AA Absorber/A.C.G.O. Switch
AB Fresh Gas to Absorber
AC O2 High Pressure Outlet
AD Air High Pressure Outlet
AE Auxiliary O2 Supply

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1.5.2 Oxygen System and Oxygen Failure Warning


Device
The BleaseSirius machines are fitted with a pneumatic circuit (See Figure 15).

Oxygen is conducted from each oxygen yoke block (F), if installed, to the
appropriate high pressure oxygen regulator input and cylinder contents gauge
which indicates the cylinder pressure.

The regulator reduces and regulates the pressure to a nominal


(310.3kPa/45psi). The outlet of each regulator is coupled by a non-return
valve to a common oxygen supply line. The cylinder regulator pressure is
deliberately set low to give preference to the pipeline supply.

Oxygen may also be conducted from the oxygen pipeline input (E) to its
pipeline pressure gauge, which indicates the pipeline pressure, and through a
non-return valve to the common oxygen supply line.

The common oxygen supply line is connected directly to the input of the On/
Off switch (M), the oxygen flush control (R), and the input of the oxygen high
pressure outlets I, and some of the control valve pilots.
The output of the On/Off switch (M) is connected to:
the input of the oxygen failure warning device (I)
the input to the secondary oxygen regulator Q for the mechanical
hypoxic guard
Each of the gases except oxygen and MED AIR have their outputs controlled
by a cutout valve. The purpose of the cutout valves is to shut the gases off if
the oxygen supply pressure falls below 225kPa/32.6psi. In such an event MED
AIR, if requested, will automatically be supplied to the ventilator and is also
supplied to the MED AIR flowmeter.

The cutoff system also activates the oxygen failure warning device (I), which
produces a warning signal in the form of a whistle when the oxygen supply
pressure falls below 225kPa/32.6psi. It has its own reservoir (H) to ensure
that the warning signal lasts for at least 8 seconds. An alarm also sounds on
the ventilator.

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When the On/Off switch (M) is turned On, oxygen is supplied to the oxygen
flow control (via the secondary regulator (Q), the reservoir (H) and control
inputs of the other gases cutouts. An alarm sounds on the ventilator.

When the switch is turned Off the oxygen no longer reaches the oxygen flow
control or the signal inputs of the cutouts and they switch off, thus cutting off
all the gases from the flowblock assembly.

The oxygen flow control adjusts the flow of oxygen into the gas mixing section
of the machine. The flow of oxygen is measured by the mechanical flow tube
or the electronic flow sensor (EFM) that is mounted directly above the oxygen
flow control.
The oxygen passes from the flow tube or flow sensor into an oxygen-
preferential mixing chamber where it mixes with the other gases and then
to the vaporizer backbar or manifold assembly. It then passes through the
vaporizer (W) where it picks up anesthetic vapor and passes to the common
gas outlet (X) of the machine via a non-return valve.

The non-return valve prevents the oxygen flush control from pressurizing the
vaporizers when it is operated, as both the output of the oxygen flush control
and the vaporizers are connected to the common/auxiliary common gas outlet.

There is a relief valve (Y), which will open to atmosphere if the gas pressure at
the outlet reaches approximately 27.6-34.5kPa/3-4psi (as a result of the outlet
being blocked or some fault in the patient system). The entrainment valve,
where installed, will open to atmosphere if the gas pressure at the outlet falls
to less than -4cmH2O as a result of a patient attempting to breathe when the
supply of gas to the auxiliary common gas outlet is insufficient.

The system will also give an alarm on the ventilator if oxygen fails.

Do not use the anesthesia system if the hypoxic guard control system
does not operate within permitted ranges. Using an incorrectly
operating control system may result in incorrect gas mixtures and injury
to the patient.

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1.5.3 Nitrous Oxide System (Optional)


If your machine has the electronic flow meter, air is the madatory second
gas. Nitrous oxide is optional.

Nitrous oxide is conducted from each nitrous oxide yoke block (D) to the
appropriate high-pressure nitrous oxide regulator input and cylinder contents
gauge which indicates the cylinder pressure.
The regulator reduces and regulates the pressure to a nominal
310.3kPa/45psi. The outlet of each regulator is coupled by a non-return valve
to a common nitrous oxide supply line. The cylinder regulator pressure is
deliberately set low to give preference to the pipeline supply.

Nitrous oxide may also be conducted from the nitrous oxide pipeline input
(C) to a pipeline pressure gauge which indicates the pipeline pressure and
through a non-return valve to the common nitrous oxide supply line.

The common nitrous oxide supply line is connected to the input of the nitrous
oxide cutout . The output of the nitrous oxide cutout is connected to the
input of the secondary nitrous oxide regulator (P), onto the nitrous oxide flow
control, (T).

When the On/Off switch is turned On the oxygen pressure at the control input
of the nitrous oxide cutout valve causes it to open and allow nitrous oxide to
reach the nitrous oxide flow control. If the On/Off switch is in the Off position or
the oxygen supply pressure has fallen to less than 225kPa/32.6psi, the nitrous
oxide cutout will shut, thus cutting off the flow of nitrous oxide.

The nitrous oxide flow control adjusts the flow of nitrous oxide into the gas
mixing section of the machine. The value of the nitrous oxide flow is measured
by using a flow tube/flow sensor (EFM) mounted directly above the nitrous
oxide flow control.

The action of the mechanical hypoxic guard (U) is to provide a mechanism


such that the oxygen and nitrous oxide flow controls are linked together (by a
system of gear wheels), so that the ratio of oxygen to nitrous oxide is greater
than 25%.

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The nitrous oxide passes from the flow tube/flow sensor into a mixing chamber
where it mixes with the other gases, and then to the vaporizer backbar or
manifold assembly. It then passes through the vaporizer (Y) where it picks up
an anesthetic vapor and passes to the common gas outlet (X) of the machine
via a non-return valve.

1.5.4 Medical Air System (Optional)


If your machine has the electronic flow meter, air is the madatory second
gas. Nitrous oxide is optional.

Medical air is conducted from the pipeline system input (A) to a pipeline
pressure gauge, which indicates the pipeline pressure via a non-return valve
to the O2 failure MED AIR switching device. The output of the non-return valve
is also conducted to the auxiliary MED AIR output, if required.

A MED AIR cylinder yoke option is available and the connection is similar to
other gases, i.e. Yoke/Regulator/NRV, etc. In the event of an Oxygen supply
failure, MED AIR is supplied to the ventilator and the MED AIR switch is
overridden, thereby supplying MED AIR to the breathing system via the MED
AIR flowtube.

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1.5.5 Controls
1.5.5.1 On/Off Switch
The On/Off switch is located on the front of the machine below the flowmeters.
It must be in the On position for oxygen to flow through the machine.
Since the machine has a hypoxic guard installed, the On/Off switch must
be turned to the Off position to reduce oxygen flow to zero. The O2 flow
control valve can only reduce the flow to 150ml/min 20ml/min.
Excessive force on the O2 or N2O control valves may damage the
hypoxic guard mechanism.
The On/Off switch also activates the O2 failure warning system. You may hear
a brief warning whistle when the switch is activated.

1.5.5.2 Flow Controls


Two types of flow meters are available for the BleaseSisius: mechanical
(standard) or electronic (optional).

1.5.5.2.1 Mechanical Flowmeter


The standard mechanical flowmeter consists of a
single flow tube with a rotating float and a dial for each
gas. A cascade-style flowmeter option is also available
for the BleaseSirius. The cascade style has a small
low-flow and a larger high-flow tube for each gas. The
flow valves control the actual gas flow and are color-
coded for each gas according to ANSI or ISO color
specifications. The gas flow in L/min is identified at
the top of the rotating float in the flow tube.

You turn the valves counter-clockwise to increase flow


and clockwise to decrease flow. For cascade-style flow
tubes, the gases pass through the low flow tube first,
and then through the high flow tube. Therefore, gas
flows below 1 L/min are read on the low flow tube and Figure 16 - Mechanical
those above 1 L/min are read on the high flow tube. Flowmeter

A hypoxic guard is installed in the flowblock, so the O2 flow cannot be reduced


to zero using the flow control dial. The minimum basal flow is 150ml/min
20ml/min.

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Always check that the gas flows are off or at a low flow before turning
on the machine to prevent damaging the hypoxic guard.
Excessive force applied to the control valves may damage the hypoxic
guard. To reduce the oxygen flow to zero, turn the machine On/Off
switch to OFF.
The oxygen control valve is always located on the extreme left of the flowblock
assembly housing on ISO-specification machines and on the extreme right on
ANSI-specification machines.

An auxiliary oxygen flowmeter with a barbed fitting is available to provide flow of


up to 80 lpm max up to max 400kPa/58.0psi at 0 flow.

1.5.5.2.2 Electronic Flowmeter Option


The electronic flowmeter (EFM) option provides a
digital representation of gas flow for each flow sensor
and rotating float. EFM includes flow control valves that
are color-coded and arranged according to ISO or ANSI
specifications. You use these valves to control the gas
flow.

The actual gas flow in L/min is identified at the top of


the rotating float in the digital flow sensor and on a
digital readout under each flowtube. Total gas flow is
shown in the flow sensor on the right side of the EFM.
In the event of a screen failure, the total flow sensor will
display the total fresh gas being delivered to the breath-
ing system.
Figure 17 - Electronic
Flowmeter, 3 Gas Option
Turn the valves counter-clockwise to increase gas flow
and clockwise to decrease gas flow. The oxygen con-
trol valve is always on the extreme left of the flowblock
assembly housing on ISO-specification machines and on the extreme right on
ANSI-specification machines.
The EFM powers on when the system powers on. The Spacelabs Healthcare
logo is displayed during boot-up.
If you see the warning triangle on the EFM screen at any time, do not
use the machine. Contact your local Spacelabs Healthcare service
representative or Spacelabs Global Technical Support as soon as
possible.

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EFM Data Output


The EFM is connected to the ventilator.
During a case, the O2, Air and N2O con-
sumption is displayed in liters on Page 2
of the System Information screen. All flow
data is transferred to the ventilator for fur-
ther review or export to the hospital infor-
mation system via the RS232.

Figure 18- Gas Consumption Data,


System Information Screen
Accuracy of EFM Flow Measurements
Gas Flow Measurement Accuracy
O2* 10%-100% Full Scale (1.5 - 15 L/min): better than 10% of
reading or 150 ml/min when < 10% of full scale.
N2O* 10%-100% Full Scale (1.5 - 12 L/min): better than 10% of
reading or 150 ml/min when < 10% of full scale.
AIR* 10%-100% Full Scale (1.5 - 15 L/min): better than 10% of
reading or 150 ml/min when < 10% of full scale.
Total Gas Flow** better than 10% of reading at 5, 10, and 15 L/min
* Accuracy referenced to operation at 21C (70F) and 1013 mbar.
**Accuracy measured with O2 at 21C (70F) and 1013 mbar.

EFM-Specific Alarms
If you see the warning triangle on the EFM screen at any time, do not
use the machine. Contact your local Spacelabs Healthcare service
representative or Spacelabs Global Technical Support as soon as
possible.

One priority alarm is associated with the EFM - Check Total Flow. This alarm
is displayed on the Ventilator screen during one of three conditions:

1. when the fresh gas oxygen flow is below 100 ml/min.


2. if a gas flow is absent (indicated by a dashed line)
3. if the ventilator receives no flow data from the EFM for more than 90
seconds.

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1.5.5.3 Auxiliary Flowmeter


A built-in auxiliary oxygen flowmeter provides an independent O2 supply to the
mechanical flowmeter (or EFM, if installed).

1.5.5.4 Oxygen Flush, O2 + Button


The oxygen flush button (O2+) is located on the front of the machine below the
work surface. Press the button to supply 100% oxygen to the common gas
outlet at a flow rate of between 45 l/m and 50 l/m.
The control is non-locking.

1.5.5.5 Hypoxic Guard


The Mechanical Hypoxic Guard is a non-adjustable device that prevents
the oxygen concentration delivered in an oxygen/nitrous oxide mixture from
falling below 25%, if there is an adequate supply of oxygen on the anesthesia
machine.

The Hypoxic Guard consists of regulated supplies of oxygen and nitrous


oxide, their flow control valves and their associated flowblock assemblies.
The oxygen flow control valve and the nitrous oxide flow control valve are
linked together by a gear mechanism that automatically opens the oxygen
flow control valve or closes the nitrous oxide flow control valve should the
adjustment of either by the user be likely to cause the percentage of oxygen in
the resulting mixture to be less than 25%.

The gear mechanism allows the control valves to be independently adjusted


if the percentage of oxygen in the mixture is greater than 25%. To ensure that
the minimum percentage of oxygen is achieved at low gas flows, the oxygen
control valve cannot reduce the flow of oxygen below 150ml/min 20ml/min.
The oxygen and nitrous oxide flow control valves and their linking gears are
incorporated in a flowmeter assembly/flow control unit assembly.

The other gases controlled by the flowmeter assembly/flow control assembly


are not affected by the hypoxic guard.

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Excessive force applied to the flow control valves may damage the
hypoxic guard. To reduce the oxygen flow to zero, turn the machine On/
Off switch to OFF.

25% O2 is the minimum nominal mixture. The tolerance is 21-30%


throughout the range, except where N2O is set to 10.0 lpm when it is 21-
35%.
The hypoxic guard control system only ensures that oxygen - nitrous
mixtures will have a minimum oxygen concentration. HYPOXIC
MIXTURES MAY BE DELIVERED IF GASES OTHER THAN OXYGEN,
NITROUS OXIDE OR MED AIR ARE USED, OR WHEN OPERATING AT
LOW OXYGEN FLOW RATES.

1.5.5.6 Vaporizers
The level of anesthetic gas vapor is selected using the control dial on the
vaporizer unit. See the Vaporizer User Manual for more information before
use.
Maintain sufficient fresh gas flow when using sevoflurane.
The performance of the anesthesia machine and the vaporizers
may be degraded if the two are mismatched. Refer to the vaporizer
manufacturers instruction manual before use.

1.5.5.7 Brake Pedal


The brake pedal enables the user to lock the front trolley wheels in place,
preventing movement.

To lock the brake:


Depress the front part of the pedal toward the floor. When you hear
the click, then the brake is locked. The pedal sits at a 45 angle when
locked.

To unlock the brake:


Place your foot flat onto the back part of the pedal and depress firmly
downwards. You will hear a click sound as the brake is released. The
pedal is flat and horizontal when it is unlocked.

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1.5.5.8 Drawers
The BleaseSirius is fitted with either 1,2 or 3 drawers, depending on the
system configuration. The drawer(s) slide open and closed .

To lock the drawers:


Insert the key into the lock located on the right side of the drawer.
Turn key clockwise and then remove the key to lock the drawer.

To unlock the drawers:


Insert the key and turn it counter-clockwise to open the drawer.

1.5.5.9 Flowmeter Backlight and Da-lites


The flowmeter backlight and Da-lites lights are the work surface lights. They
switch on and off simultaneously. On the right side of the work surface lights,
there is an auxilliary work surface light. This light is always on when the
flowmeter backlight is on or, if you have the electronic flowmeter (EFM). The
flowmeter backlight is not available if your system has the EFM.
Function of the flowmeter backlight is to illuminate readings on the fresh
gas flowmeter tubes. If you have the mechanical flowmeter, you can
disable this feature in the ventilator software. Note that if you have the
EFM, the backlight option is not available.
The Da-Lites are activated by motion sensor when
you use the vaporizers. They remain lit until you
move your hands away from the vaporizers.

To turn on or off the backlight/Da-lites (work


surface light):
1. Select Setup on the Home screen.
2. Select Configuration.
3. Select Backlight.
4. Check the Backlight box to turn it on
5. Uncheck the Backlight box to turn it off.
6. Select Return until you see the Normal screen.

Figure 19 - Select Backlight Screens

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Section 1 - BleaseSirius Anesthetic Machine

1.5.5.10 Maneuvering the Machine


When maneuvering the anesthesia machine, ensure that the brake pedal
is released. Always use the system handles to move the machine.

Left Side Handle

Right Side Handle

Figure 20 - System Handle Locations

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Section 1 - BleaseSirius Anesthetic Machine

1.6 User Maintenance Schedule


Refer to the recommendations of your local professional association
regarding maintenance checklists. Instructions for maintaining the
BleaseSirius machine are provided by Spacelabs Healthcare in Sections
1.7 through 1.10.
During certain maintenance or sterilization procedures, system
components may be disconnected. Always confirm that your system is
setup properly anytime you disconnect system components.

Maintenance Recommended Frequency See Section(s)


Pre-Use Check* Daily 1.7 and 2.3.1
Full System Check Daily 1.8 and 2.3.4
Cleaning Daily 1.9 and 2.4.4
Sterilization After use or per hospital 1.10 and 2.4.4
infection control policy
Service by a qualified Annually Contact your local
technical engineer Spacelabs Healthcare rep-
resentative to schedule an
appointment.

*At the end of the Pre-use Check, you have the option to perform a
full system test. Although it is not necessary to perform each time the
machine is turned on, you should perform a full system test daily.

1.7 Pre-Use Checks


Perform the following Pre-Use Checks daily.

1.7.1 Gas Supply Hoses and Probes Check


1. Switch the machine off, if necessary.
2. Inspect the gas supply hoses and probes for damage, particularly at the
hose connections.
3. Inspect the rubber and plastic ancillaries for signs of swelling, cracking,
splitting or tackiness. Replace faulty components, as necessary.

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Section 1 - BleaseSirius Anesthetic Machine

1.7.2 Cylinder and Pipeline Supplies Check


1. Check that all the cylinders are securely and correctly mounted in their
yokes.
2. Disconnect all the pipeline supplies and turn off all gas cylinders.
3. Turn on each cylinder in turn and check that its contents gauge registers
an adequate supply of gas.
4. Turn off each cylinder in turn and check that there is no observable
change in the gauge reading over one minute.
5. Reconnect the pipeline supplies and check that their respective pressure
gauges indicate the hospital pipeline pressure.

1.7.3 Flowblock Assemblies Check


1. Turn all the flow control valves fully clockwise and check that no gas
flows show on the flowblock assemblies. If the electronic flowmeter (EFM)
is installed, total flow is not displayed on the total flowmeter when the
system is off.
2. Switch on the machine.
3. Check that no gas flows are registered on any of the flowblock, except
for the oxygen flowblock assembly. This assembly should register flow of
150ml/min 20ml/min. If the system has EFM, wait until the unit powers
up and the flowtubes are displayed, then check the O2 flow.
4. Adjust the flow of all gases through their full range and check for erratic
float movement.

1.7.4 Oxygen Failure Warning System Check


1. Shut off the oxygen cylinders and pipeline. The other gas supplies should
remain on and the flow control set to deliver > 1 l/m.
The ventilator alarm sounds if oxygen fails. If the system has EFM, the
Check Total Flows message is displayed on the ventilator screen.

Prior to connecting the machine to the patient carry out the pre-use check
to verify correct alarm operation. To verify the O2 alarm, set the flowmeters
to give a concentration of 50% oxygen. Using the controls on the oxygen
monitor panel, set the low oxygen level to 60% and verify the oxygen low
alarm operates. Set the high oxygen alarm level to 40% and verify that the
oxygen high alarm operates.

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Section 1 - BleaseSirius Anesthetic Machine

2. Check the following:


a. As the remaining oxygen is depleted, the oxygen failure warning
whistle is activated for at least 8 seconds;
b. The gas flows through the flowblock assemblies are all stopped,
except MED AIR.
3. Restore the oxygen supply and check that the gas flows through the
flowblock assemblies are restored.
4. Turn the nitrous oxide flow control counter-clockwise until a flow of
10 l/m is indicated on the nitrous oxide flowblock assembly. Check that
the indicated flow through the oxygen flowblock assembly is 2.6 to 4.9 l/m.
5. Turn the oxygen flow control clockwise until a flow of 1.5 l/m is indicated.
6. Check that the nitrous oxide flowblock assembly is indicating 5.6 l/m to
3.5 l/m.

1.7.5 Leak Test -Vaporizers


1. Check that each vaporizer for the required volatile agents is installed
correctly to the machine, that the backbar lock is fully engaged and that
the control dial(s) rotate through their full range. Turn off the vaporizer.
2. When charging each vaporizer, ensure that the correct anesthetic agent is
used and that the filling port is tightly closed.
3. Set a suitable flow of oxygen (6 to 8 l/m), turn the vaporizer off and
temporarily occlude the common gas outlet. There should be no leak from
any of the vaporizer fittings and the oxygen flowtube float should dip.
4. Repeat this test with each vaporizer turned on. There should be no liquid
leak from the filling port.
5. Turn off each vaporizer and the oxygen flowblock assembly control dial.

Any vaporizer installed on the anesthetic machine shall comply with ISO
8835-4. Additionally, while the vaporizer is in use, an anesthetic agent
monitor complying with ISO 11196 must be used.

When using external patient circuits, there is possible risk of high


pressure.

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Section 1 - BleaseSirius Anesthetic Machine

1.7.6 C.G.O. Safety Valve


1. Occlude the C.G.O. outlet.
2. Push the flush tap.
3. Listen for an audible sound indicating the valve is functioning.

1.7.7 A. C.G.O. Safety Valve (if installed)


1. Occlude the A.C.G.O. outlet.
2. Push the flush tap.
3. Listen for an audible sound indicating the valve is functioning.

1.7.8 General
1. Confirm correct operation of vaporizers, APL valve, ventilator, scavenging
and absorbers according to the instructions given in their respective
manuals.
2. Check that:
a. The absorbent is fresh.
b. The vaporizers are not empty.
c. The breathing system is gas tight by performing the ventilator pre-
use tests.
d. All alarms are working.
Always perform the ventilator pre-use test procedures for volume
sensing functions after cleaning or replacing the volume sensor and/or
reconnecting any components of the breathing system before use.

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Section 1 - BleaseSirius Anesthetic Machine

1.8 Full System Test


1.8.1 Leak Test
1. Ensure that:
Only one cylinder of each gas is installed securely and correctly to the
machine, if the system has cylinder(s) installed.
No pipelines are connected to the machine.
The cylinder is closed (turned off).
All the flowblock assembly controls are turned fully clockwise.
No equipment is plugged into the pneumatic power outlets;
The machine is switched off.
The oxygen transducer is connected and in room air.
2. Open the cylinder and check that its gauge indicates the cylinder
pressure. Note the correspondence between the cylinders and their
gauges.
3. Close the cylinder and check that the pressure indication on its gauge
does not decrease. If any cylinder gauge indication decreases by more
than half a division in three minutes, an unacceptable leak exists. If the
leak persists after ensuring that the cylinder is correctly installed, the
machine should be referred to the Technical Support Department.
4. Remove the cylinder and repeat the above procedure for each cylinder
yoke in turn.
5. Remove the cylinder from the machine.
6. Attach each pipeline in turn and check that each pipeline supply pressure
gauge is indicating the correct pressure.
7. With at least one source of each gas connected, turn on the machine.
Increase the flow control of each gas to the maximum flow (fully counter-
clockwise). Check that each gas registers a flow on the appropriate flow
tube (or sensor for EFM) and discharges throughn the fresh gas outlet.
Reduce the flows to the minimum, then turn off the machine off.

Leaking gases and vapors (downstream of the flow control valves and
oxygen flush valve) may deprive the patient of metabolic gases and
anesthetic agent may pollute the atmosphere. Tests that detect leaks
must be performed frequently. If detected, the leak must be rectified.

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Section 1 - BleaseSirius Anesthetic Machine

1.8.2 On/Off Switch and Warning System Checks


1. Switch on the machine .
2. If the oxygen supply failure alarm operates for more than a few seconds,
check that oxygen supply cylinders or pipeline are correctly installed and
are at the correct pressure.
3. The machine is fitted with a mechanical hypoxic guard. Check that there
is a standing flow of 150ml/min 20ml/min through the oxygen flowblock
assembly, with the oxygen flow control valve turned fully clockwise.
4. Increase the oxygen flow to approximately 4 l/m.
5. Turn all the flow control valves counter-clockwise so that the flow
indicated by each flow tube or flow sensor assembly is 1 l/m.
6. Simulate an oxygen supply failure by shutting off or disconnecting the
oxygen supply cylinder(s) or pipeline(s).
7. Check that the oxygen failure warning device is activated after the
pressure of the oxygen remaining in the machine has fallen. Verify that:
its whistle sounds for at least 8 seconds.
all the other gases on the machine are shut off with the exception of
MED AIR, if installed (i.e., the readings on the flowblock assemblies
indicate zero).
8. Reconnect the oxygen supply and check that:
the oxygen failure alarm is cancelled.
the gas flows through the flowblock assemblies are restored.
9. Disconnect or shut off the nitrous oxide supply (cylinder and/or pipeline)
and check that:
the flow indicated in the nitrous oxide flowblock assembly reduces to
zero.
the flows indicated on the other flowblock assemblies remain unaltered.
10. Reconnect or turn on the nitrous oxide supply.
11. Repeat 9 and 10 for all the other gas supplies on the machine.

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1.8.3 Mechanical Hypoxic Guard Test


The machine has a mechanical hypoxic guard installed. Test its function as
follows.
1. Turn the oxygen and nitrous oxide flow control valves fully clockwise.
2. Check that the oxygen flow indicated on the oxygen flowblock assembly
is 150ml/min 20ml/min and that no flow is indicated on the nitrous oxide
flowblock assembly.
3. Increase the nitrous oxide flow (turn the valve counter-clockwise) to 10
l/m and check that the oxygen flowblock assembly indicates an oxygen
flow of 2.6 to 4.9 l/m.
4. Turn the oxygen flow control valve counter-clockwise until an oxygen flow
of 6 l/m is indicated.
5. Check that the indicated nitrous oxide flow remains between 9.5 and 10
l/m.
6. Gradually reduce the oxygen flow and check that the nitrous oxide flow
has begun to decrease when the oxygen flow decreases below 2.8 l/m.
7. Turn the oxygen flow control valve clockwise until a flow of 1.5 l/m is
reached. Check that the nitrous oxide flowblock assembly is reading 5.6
to 3.5 l/m.
8. Turn the nitrous oxide control valve fully clockwise.
9. Ensure all the flow control valves are turned fully clockwise and then
switch the machine off.

1.8.4 Oxygen Flush Tap Test


With only oxygen connected to the machine, verify that the oxygen flush
discharges gas through the common gas outlet.

1.8.5 Auxiliary Outlet Test


1. Depending on the configuration of the auxiliary outlet (Oxygen or MED
AIR), attach the appropriate gas to the machine.
2. Verify that gas flows from the outlet port when a probe is connected.

1.8.6 HP Outlet Test (if installed)


1. Depending on the configuration of the HP outlet (Oxygen or MED AIR),
attach the appropriate gas to the machine.
2. Verify that gas flows from the HP outlet when a probe is connected.

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Section 1 - BleaseSirius Anesthetic Machine

1.8.7 Ventilator Test


1. Connect oxygen supply to the machine and check that ventilator is
functioning. See Section 2.2.7 Pre-use Testing in this manual for
instructions on compliance and system testing of the ventilator. These
tests should be performed daily.
2. Connect MED AIR and disconnect the oxygen supply and confirm that the
ventilator is still functioning.
3. Switch off the mains electrical supply and confirm that the ventilator is still
functioning. Check that the mains failure alarm activates. Verify battery
status (See Section 2.1.7 in this manual).

1.9 Cleaning
Stainless steel, painted and anodized aluminum components and surfaces
should be cleaned with a damp cloth and a mild soap. Do not use abrasive
cleaners. Clear plastic areas (the flowblock assembly cover or gauge faces)
should be cleaned with a damp, soft clean cloth and dried immediately with a
dry cloth to prevent spotting.

Some anesthetic agents may adversely affect the paint work. Any
spillage should be removed immediately.

Use cleaning solution sparingly. Do not saturate system components.


Excessive solution can damage internal devices.

Rubber and plastic parts of the machine can be cleaned with a mild
detergent and a soft cloth.

1.10 Sterilization
Patient flow sensor, tubing and breathing circuits and the bellows may require
sterilization. Please refer to the respective manufacturers manuals and current
hospital policy for more information.
Following ethylene oxide sterilization, quarantine the equipment in a well
ventilated area to allow dissipation of absorbed ethylene oxide gas. In
some cases, aeration periods of seven days or more may be required.
Aeration time can be decreased when special aeration devices are used.
Follow the sterilizer manufacturers recommendations for required
aeration time.

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Section 2
700/900 Series
Ventilators

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Section 2 - 700/900 Series Ventilators

Identify Your Ventilator


Use the table below to identify your ventilator model, then refer to relevant
sections of the manual.

700 Series 900 Series


Model Number 720 730 750 950 970 990
Screen Size 8.4 8.4 8.4 8.4 8.4 8.4
Display Mono Mono Mono Color Color Color
Interface Touch & Touch & Touch & Touch & Touch & Touch &
Trak Trak Trak Trak Trak Trak
Tidal Volume
Compensation
Configurable preset or
measured compliance
Vent Mode
Volume Control
Pressure Control
SIMV-VC/SIMV-PC + PSV *
Precision Pressure
Support
Vent Monitoring
Oxygen
Exhaled Volume
Monitoring
Airway Pressure
Pressure Waveform
Flow Waveform
Spirometry Loops
Data Output
* The 730 Ventilator only supports SIMV-VC+PSV mode. The Pressure Control modes are not
available on this model.

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Section 2 - 700/900 Series Ventilators

2.1 Description of the Ventilator


2.1.1 Overview

The Blease700/900 series ventilator is an advanced, microprocessor-control-


led, pneumatically driven ventilator, which has been designed specifically for the
mechanical ventilation of adult and pediatric patients under general anesthesia.

The control unit houses the electronic and pneumatic control systems. It sets
the desired ventilatory parameters and generates alarm, warning and status
messages. The control unit also calculates and implements the functions nec-
essary to drive the bellows pneumatically.

The bellows assembly consists of a base and a bellows housing.

The Blease700/900 series ventilator is designed for use with a circle-type ab-
sorber and is ideally suited to both low-flow and high-flow applications. The
patient flow sensor(s) and its associated tubing are an important part of the
ventilator. This gives the ventilator the inspired and expired flow and patient
airway pressure measurements. The ventilator may also be used with either a
Bain-type coaxial circuit or a Jackson-Rees/Ayres T-piece type pediatric circuit
by using an adaptor.

Variations are based on the drive gas used (MED AIR or oxygen) and the drive
gas connector type (depending on the eventual country of use).

See Section 2.7 Associated Equipment and Accessories for ordering


information for the various types.

Figure 21 - 900 Series Ventilator

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Section 2 - 700/900 Series Ventilators

2.1.2 Features
The features available for your ventilator depend on the operating mode.

2.2.2.1 Controls and Indicators


The operating parameters of the ventilator are set by using a combination of
touch screen and Trak Wheel. Parameter values are shown on the touch
screen.
2.2.2.2 Microprocessor Control
The built-in microprocessor control system makes it easy to upgrade and
customize the unit.
2.2.2.3 Dual Mode Ventilation
The ventilator can be used as either a flow generator or a pressure generator
and, in both cases, it is time cycled. Therefore, ventilation can be tailored to meet
all patient requirements as each mode has an adult and pediatric application. In
addition to this feature, the ventilator can be triggered by patient flow.
2.2.2.4 Pressure Limit Control
This feature prevents barotrauma and gives maximum safety by ensuring
accurate, safe ventilation to a pre-set pressure limit.
2.2.2.5 Built-in Ventilator Pre-use Test
A ventilator Pre-use Test System ensures accurate ventilator delivery irrespective
of system back-pressure.
2.2.2.6 Comprehensive Pressure Monitoring and Alarms
Selectable functions allow Airway, Peak and Mean Pressure monitoring
spirometry. High and low airway flow and Apnea alarms are present. A range of
measurements, such as O2 level, Plateau Pressure, Fresh Gas and Inspiratory
Volume, are provided.

Alarms activate to warn of possible disconnection, circuit leakage and un-


achieved set volumes. The alarms are audible and visible. When activated, the
alarms are listed on the display.

The mains and battery alarms also have light emitting diode (LED) indication.

Do not block the drive gas exhaust. Blocking the drive gas
exhaust may impede ventilator function.

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Section 2 - 700/900 Series Ventilators

2.1.2.7 Waveforms and Spirometry


The 700/900 series ventilator offers a simple, accurate and user-selectable
display of set and monitored tidal volumes. The user also has a choice of one
of the following on-screen waveforms:
1. Airway Pressure
2. Pressure/Volume
3. Flow/Volume
4. Airway Flow

Not all waveforms are available on certain models.

2.1.2.8 Battery Back Up


The internal battery is automatically charged when the ventilator is connected
to the mains electrical supply. If the ventilator is in the ON position and the
mains electrical power fails, the battery provides continued operation of the
ventilator for a minimum of 30 minutes, if it is fully charged. Typical operating
time is a minimum of 60 minutes. A discharged battery takes approximately 8
hours to fully charge.

2.1.2.8.1 Low Battery Indicator


The mains fail alarm will be activated and a battery symbol will appear in the
alarms panel. Symbol indicates how much charge is left in the battery.

Figure 22 - Low Battery Indicator

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Section 2 - 700/900 Series Ventilators

2.1.3 Operating Modes


Some features are only available in certain models.

There are five mechanical ventilation modes:


Volume Control
Precision Pressure Control
Advanced Pressure Support
SIMV-VC + PSV
SIMV-PC + PSV

The differences between the two patient modes, Adult and Pediatric, are:
The ventilator sustained pressure requires a greater pressure
movement in adult mode to avoid being activated.

Setting alarms and limits are, in general, optimized for lower


pressures and volumes to be used in pediatric mode.
The Pedi Sensor can only be used in the Pediatric patient mode.

Short inspiratory times may result in inconsistent breath delivery. Avoid


control combinations which may produce very short inspiratory times
(<150 ms).

Pressure limiting is a safety feature. It should not be used for any other
purpose, such as creation of micro-breaths or emulation of specialized
high frequency/low volume ventilation systems, otherwise injury to the
patient may result.

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Section 2 - 700/900 Series Ventilators

2.1.3.1 Volume Control


Volume Control Ventilation is a time-cycled mode that delivers a set volume
into the circuit within a set time. The Blease700/900 series ventilator ensures
that the delivered volume is independent of any compression losses in the
absorber, bellows and associated tubing. Changes to fresh gas do not cause
a permanent change to the delivered volume, the ventilator automatically re-
adjusts the delivered tidal volume within the next few breaths.

When the tidal volume limit is reached, the ventilator immediately cycles into
expiration.

2.1.3.2 Precision Pressure Control


Precision Pressure Control Ventilation is a time-cycled mode where the venti-
lator maintains the set inspiration pressure for the inspiratory period. The user
sets the required pressure.

The ventilator delivers volume until the set pressure limit is reached, then
it maintains the pressure until the end of the inspiratory time. The effect of
Volume and Pressure modes on the pressure and flow waveforms is shown
below:

Volume Control Mode Precision Pressure Control Mode


(PCV)

Figure 23- Volume & Precision Pressure Control Mode Waveforms

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Section 2 - 700/900 Series Ventilators

2.1.3.3 SIMV-PC + PSV and SIMV-VC + PSV Modes


SIMV-PC+PSV and SIMV-VC+PSV are extensions of the PSV mode that al-
low the patient to take breaths on demand with optional pressure support, but
includes some mandatory breaths. The mandatory breaths can be delivered
by either volume (SIMV-VC mode) or pressure (SIMV-PC mode). For Pressure
Support, the user must set a Trigger threshold and Support Pressure. Volume/
Pressure and a breath rate must also be set.

To prevent hyperventilation, any changes in the breathing rate are only al-
lowed to take place over a number of breaths. If the patient fails to make any
effort to breathe, the SIMV function automatically defaults to the ventilation
function, identical to Volume Control Mode/Pressure Control Mode at the set
SIMV rate.

The SIMV modes use a flow trigger to sense the patients attempt to
breathe. Therefore, SIMV modes cannot work with the patient sensor
placed at the absorber.

2.1.3.3.1 SIMV Interlock


A software interlock ensures that, when the ventilator is switched to an SIMV
mode, realistic inspired times are set so that patient breathing continues in as
normal a manner as possible.

When the software switches to an SIMV mode, the rules are as follows:

1. Continue with the I:E ratio that was already set. If this ratio is possible,
then the breathing pattern should remain unchanged.

2. If, however, this switch puts the inspired time at greater than 2 seconds
in adult or greater than 1 second in pediatric, then you should limit the
inspired time to that figure.

When actually in an SIMV mode:

1. When increasing the BPM, limit the highest BPM value to a point where
the I:E ratio becomes 2:1.
2. When increasing Inspired Time, limit the Inspired Time to a point where
the I:E ratio becomes 2:1.

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Section 2 - 700/900 Series Ventilators

2.1.3.4 Inspiratory Pause


When pause is activated, a percentage of the inspiratory time is used as a
plateau prior to the start of the expiratory phase. The I:E ratio is maintained
irrespective of the duration of the pause. The Pause feature is found under the
Mode Selection menu and is also available in the Volume Control and SIMV-
VC+PSV (Volume) modes. Inspiratory Pause is user selectable from 0 to 50%.
.

Figure 24 - Inspiratory Pause Waveform

2.1.3.5 Sigh
When Sigh is activated, the delivered tidal volume in Volume Control Mode
is increased by the set percentage of the duration of one breath at the set
frequency. The default percentage is 10% and default frequency is once every
tenth breath.

The fresh gas flow compensation will continue to function during a set
pause period.

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Section 2 - 700/900 Series Ventilators

2.1.3.6 Advanced Pressure Support


In Advanced Pressure Support mode, the patient controls when the ventilator
starts to deliver and when the ventilator cycles into expiration.

The start in inspiration is set by the flow trigger. After the patient has made an
attempt to breathe that exceeds the set flow trigger, the ventilator delivers at
the support pressure, until the flow is reduced to 25% of the peak flow. The
ventilator then goes into expiration.

In Pressure mode, bpm, tidal volume and I:E ratio are all monitored values.
The user must set two parameters:
the Trigger Threshold (1 L/min to 15 L/min),
the Support Pressure which is referenced to the PEEP level
(3 to 20cmH2O).

Figure 25 - Pressure/Flow/Volume Waveform

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Section 2 - 700/900 Series Ventilators

2.1.4 Principles of Operation


For active inspiration, the flow control valve is opened to provide a specific gas
flow into the bellows assembly. Simultaneously, the expiratory solenoid closes
and pressure is generated in the bellows assembly, producing an inspiratory
flow to the patient.

The flow and pressure are measured and monitored by the microprocessor
feedback system.

Expiration occurs when the flow control valve is closed and the expiratory
solenoid opens and releases the gas from the bellows assembly.

In the Pressure Control Mode, the set pressure is achieved during inspiration
and maintained at that level by allowing a controlled bypass through the ex-
piratory valve. This allows the required pressure level to be maintained while
compensating for any fresh gas flow into the patient circuit.

For expiration, the expiratory solenoid is opened, which releases the gas from
the bellows assembly.

During all modes of ventilation, an autozero is periodically applied to the flow


sensors just prior to a breath being delivered. At this point, there is no flow
through the sensors. This ensures that the measured values are maintained
as accurately as possible, regardless of environmental variations.

A safety valve is present in the drive pressure exhaust. Its function is to


protect the patient against pressures exceeding 75cmH2O 2cmH2O by
relieving the drive pressure on the bellows.

NEEP is not supported by this machine, but patient generated pressures


may be measured to - 10cmH2O, at which point an alarm will sound.

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Section 2 - 700/900 Series Ventilators

Figure 26 - Pneumatic System

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Section 2 - 700/900 Series Ventilators

2.1.5 Parameters
The following parameters can be set and/or monitored when the ventilator is in
operation.

2.1.5.1 PEEP
The Blease 700/900 series ventilator
continuously monitors and displays
the Positive End Expiratory Pressure
(PEEP). By default, a PEEP of 2 to
4cmH2O is introduced to the circuit,
caused by the bellows assembly,
which is shown as OFF, but a meas-
urement may still be displayed. A
PEEP value between 3 and 20cmH2O
can be set from the panel, with an
automatic PEEP HIGH alarm at Figure 27 - PEEP Waveform
10cmH2O above set PEEP.

For best operation of the PEEP function, avoid the use of high fresh gas
flows.

A minimum difference of 8cmH2O in adult mode and 5cmH2O in pediatric


mode is enforced between the set PEEP level and the pressure controls
shown below.

MODE PRESSURE CONTROL


Volume Control Pressure Limit
Precision Pressure Control Set Pressure
Pressure Support Support Pressure
SIMV-PC + PSV Support Pressure + Set Pressure
SIMV-VC + PSV Support Pressure + Set Volume

When the user changes a value such that it does not comply with the required
difference, the box surrounding the feature being adjusted and the value of the
feature causing limiting to be enforced is highlighted in red. The value being
adjusted could either be the PEEP level or the relevant pressure control.
The user can:
Accept the value being adjusted, in which case it will be set to the
nearest acceptable value.
BleaseSirius User Manual 95
Section 2 - 700/900 Series Ventilators

Adjust the value to a non-conflicting value.


If the user does not make the change before end of time allowed for
adjustment, the value will set to the nearest acceptable value.

2.1.5.2 Trigger
The level of negative flow caused by the patients attempt to breathe before
the ventilator initiates flow to assist the patient with the spontaneous breath.
Range: 1 L/min to 15L/min all modes (SIMV + PSV and Pressure Support).

2.1.5.3 Support Pressure


Breathing circuit pressure level for assistance with patients spontaneous
breath.
Range: 5cmH2O to 30cmH2O SIMV-PC + PSV and Precision Pressure Sup-
port modes (PEEP referenced).

2.1.5.4 Fresh Gas Compensation


0 l/m to 30 l/m of fresh gas can be compensated for and displayed on screen.

2.2.5.5 Oxygen
A fuel cell sensor can be connected to allow monitoring of 0% to 110% O2,
with alarms of 18% to 110%. The sensor can be calibrated.

If you remove the Oxygen parameter from the Measurements area on


the Normal screen, the pre-defined O2 concentration alarms remain
active. If you will use an alternate O2 monitoring device, you can disable
O2 monitoring and alarms via a password protected area in the Service
Mode. Contact your local Spacelabs representative for more information.

If the O2 measurement displays a dashed line in the Measurements area


and the O2 alarm setting reads Disabled, O2 monitoring is disabled.
You enable O2 monitoring via a password protected area in the Service
Mode. Contact your local Spacelabs representative for more information.

2.1.5.6 Tidal Volume


Volume to be delivered by the ventilator in each breath.
Range: 20ml to 1500ml all modes.

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Section 2 - 700/900 Series Ventilators

2.1.5.7 Minute Volume


Measured volume delivered by the ventilator per minute.
Range: 0.3L/m to 25L/m all modes.

2.1.5.8 Expired Tidal volume


Expired tidal volume is measured by the sensor in the breathing circuit, in
either mechanical ventilator or spontaneous breathing mode. The measured
value is displayed in the tidal volume window.

2.1.5.9 BPM (Frequency Control)


The mechanical frequency of the ventilator in breaths per minute (BPM).
Range: 2bpm to 99bpm all modes.

2.1.5.10 I:E Ratio


The ratio of the inspiratory time to the expiratory time.
Range: 2.0:1 to 1:5.0 all modes in steps of 0.1.

2.1.5.11 Pressure Limit


The breathing system maximum pressure limit.
Range: 10cmH2O to 50cmH2O Pediatric.
10cmH2O to 70cmH2O Adult.

2.1.5.12 Pressure Control/ Ptot


Available in SIMV-PC+PSV mode only.
Range: 10 cmH2O to 50 cmH2O

2.1.5.13 Peak Pressure


Range: 0cmH2O to 100cmH2O.

2.1.5.14 Mean Pressure


Range: 0cmH2O to 100cmH2O.

2.1.5.15 Plateau Pressure (Pplat)


Range: 0cmH2O to 100cmH2O.

2.1.5.16 Compliance
System compliance in ml/ cmH2O.
Patient compliance in ml/ cmH2O.

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2.1.5.17 Volume Measurement


Accuracy of Delivered Gas at = 10% or 10ml from 50ml to 1 liter, which ever is
25oC 101.3kPa/14.6psi the greater.
(volume mode)

Volume Monitoring Accuracy = 10% or 10ml, which ever is the greater.

Controlled Patient Pressure = 10% or 2cmH2O, which ever is the greater.


Monitored Patient Pressure = 5% or 1cmH2O, which ever is the greater.
Delivered PEEP = 1.5cmH2O from 4 to 20cmH2O, which ever is
the greater.
Fresh Gas Flow = 10% or 0.2L from 0.3L to 15 liters, which ever
is the greater.

2.1.5.18 Oxygen Measurement


Oxygen Concentration accuracy = 3%.
Drift < 1% over 8 hours at constant temperature.
Response time < 30 seconds for 90% change.

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2.1.6 User Interface


2.1.6.1 Front Panel
The front panel of the 700/900 series ventilator has the following controls and
indicators:

3
Figure 28 - Ventilator Front Panel

Figure 28 Key
1 LCD Touch Screen (Blease700 is
monochrome, Blease900 is color.)
2 Battery-Status LED
3 Trak Wheel

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2.1.6.2 Normal Screen


The Normal screen is divided into four display areas: Activity, Alarms,
Measurements and Parameters.
1
4

Figure 29 Key
1 Alarms List
3
2 Parameters
2 3 Measurements
4 Activity

Figure 29 - Normal Run Screen

2.1.6.2.1 Home Key


Pressing the Home Key (when shown) returns you to the
Normal screen. The Home Key is not shown in all menu
options, only when appropriate. Figure 30 - Home
Key
2.1.6.3 Activity Display Area
The activity area includes a graphical display updated in real time to show the
breathing cycle. The graph is auto-scaled to fit on the y-axis and to show three
cycles on the x-axis.

3
1

2
Figure 31 Key
1 Waveform Display
2 Peak Marker
3 Status Line

Figure 31 - Activity Display Area

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Below the waveform, the status line shows:


The current ventilator mode (Volume Control, Precision Pressure Control,
Pressure Support or SIMV + PSV)
Adult or Pediatric mode
Pause (when selected)
Sigh (when selected)

2.1.6.4 Alarms Display Area


The alarm display lists any active alarms, with the most recent at the top of
the list. The alarm settings for the current mode of operation are shown at the
bottom of the alarm display area.

High level alarms are displayed as a red banner and white text in the
alarm list.

Medium level alarms are displayed in a yellow banner and white text in
the alarm list.

Low level alarms are only displayed in yellow text in the alarm list.

2.1.6.5 Measurements Display Area


The measurements display area is a series of five windows that each displays
a user-selected measurement to be monitored.The measurements are
selected on the Setup>Configuration>Measurements menu.

2.1.6.6 Parameter Display Area


The parameters display consists of a series of windows that each displays a
parameter that has been selected for monitoring, or an operating level that has
been set for the current function.

If a parameter has a pre-set level, as well as a monitored value, the pre-set


level is indicated at the bottom left of the parameter window and the monitored
value is shown in the larger font to the right of the window.

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Figure 32 Key
3
1 Monitored Value
1
2 2 Pre-Set Level
3 Parameter
Figure 32 - Parameter Display Area

Periodically check that VTE measurements (1) match expected delivery


(2).

2.1.6.6 Trak Wheel & Touch Screen


The Trak Wheel is a dial that allows you to move the highlight bar left or right
across the screen to select options displayed on the screen. You can also use
the Trak Wheel to scroll through and select settings.

The Touch Screen allows you to select options and confirm settings by tapping
the screen. You can use a combination of both touchscreen and Trak Wheel
controls to select and change parameters.

2.1.6.6.1 Using the Trak Wheel


2.1.6.6.1.1 To Select a Parameter
1. Turn the Trak Wheel to highlight the desired parameter on the screen.
2. Press the Trak Wheel to select the parameter.

The selection is cancelled if the Trak Wheel is not moved for


approximately 5 seconds.

2.1.6.6.1.2 To Change a Parameter Setting


1. When a parameter is selected, turn the Trak Wheel clockwise to increase
the numerical value or counter-clockwise to decrease the value.
2. Press the Trak Wheel when the desired value is displayed to confirm the
setting.

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2.1.6.6.1.3 To Select a Menu Option


1. Open the appropriate menu.
2. Turn the Trak Wheel to highlight a menu option. If a menu option is
displayed in white, you cannot select it in the current operating mode.
3. Press the Trak Wheel to confirm your selection.
4.
2.1.6.6.1.4 To Define Parameters from the Normal Screen
1. Turn the Trak Wheel until the desired parameter is highlighted.
2. Press the Trak Wheel to activate that parameter.
3. Turn the Trak Wheel until the desired setting is displayed.
4. Press the Trak Wheel again to confirm the new setting.

2.1.6.6.2 Using the Touchscreen


Use your fingertip to activate the touchscreen. Do not use pens or
pencils or any other sharp instruments to touch the screen as these
items will damage the screen.

2.1.6.6.2.1 To Select a Parameter


1. Touch the box for the parameter you want to change. The up and down
arrow buttons and the Confirm button are now active.

2.1.6.6.2.2 To Change Parameter Setting on a Menu


1. Touch the Setup or Alarm Setup button
2. Touch the desired option.
3. Touch the desired parameter to display your settings options.
4. Touch the desired setting.
5. Touch Return until the Normal screen is displayed.

If you do not touch the Confirm button, the original value will be
restored. If you do not make a selection within 30 seconds, the menu will
timeout and the original value will be restored.

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2.1.6.6.2.3 To Select a Menu Option


1. Open the appropriate menu.
2. Touch the desired menu option to highlight it. If a menu option is displayed
in white, you cannot select it in the current operating mode.
3. Touch Confirm to activate your selection.

2.1.6.6.2.4 To Change a Parameter on the Normal Screen


1. Touch the desired parameter to highlight it on the screen.
2. Touch the up/down arrow buttons to display the desired setting.
3. Touch Confirm to accept the new setting.

2.1.7 Battery Status LEDs

Icon Color Function


Mains Failure - the mains power supply has
RED failed and the ventilator is running on its internal
battery.
Battery Low - the battery is running low and the
AMBER mains supply should be connected to recharge
the battery immediately.
Mains power supply is available.
The battery charging circuit is active.
GREEN
This indicator glows green whenever mains
power is connected to the ventilator

The green light shows whenever the charge unit is active and should not
be interpreted as a direct indication of battery status.

Additional battery status information (Volts) may be obtained from the


System Information screens - See section 2.2.27.9.

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2.1.8 Menu Tree


2.1.8.1 Setup Menu Figure 33 - Setup Menu Tree

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2.1.8.2 Defaults Menu

Figure 34 - Defaults Menu Tree

2.1.8.3 Alarm Setup

Figure 35 - Alarm Setup Menu Tree

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2.2 Using the Ventilator


This section describes how to:
start/stop the ventilator.
perform pre-use testing.
select the ventilator operating mode and functions.
set the ventilator operating parameters.

Short inspiratory times (<150ms) may result in inconsistent breath


delivery. Avoid control combinations which may produce very short
inspiratory times (<150ms).

Pressure limiting is a safety feature and is also used in the adult and
pediatric mode to provide ventilation (Precision Pressure Control).
Do not use this feature for any other purpose, such as creation of
micro-breaths or emulation of specialized high frequency/low volume
ventilation systems. Otherwise, injury to the patient may result.

Patient circuit disconnection is a hazard to the patient. Take extreme care to


prevent such an occurrence.

Monitored values require a few minutes to stabilize after the initial ventilator
activation. The ventilator and set values will function correctly.

2.2.1 Power On the Ventilator


To power on the ventilator, turn on the system power. The ventilator screen
displays the pre-use test option. After you select to perform the tests or bypass
them, the ventilator powers up in Standby mode, with monitoring in standby.

2.2.2 Start the Ventilator


To start the ventilator, turn the BAG/VENT switch on the
absorber to VENT.

Figure 36 - Bag/
Vent Switch - Vent

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2.2.3 Stop the Ventilator


To stop the ventilator, turn the BAG/VENT switch on the
absorber to BAG.

2.2.4 Activate and Monitor Alarms


Figure 37 - Bag/
The ventilator monitoring alarms are activated with the
Vent Switch - Bag
detection of 3 breaths.

2.2.5 End of Case


Turn the BAG/VENT switch to BAG on the absorber,
then select the End of Case button. The End of Case
options shown on the screen (Figure 38). Select the
desired option to continue. The case timer stops.

2.2.6 Power Off the Ventilator Figure 38 - End of Case


To power off the ventilator, turn off the system power Options
switch. The ventilator shuts down. If you accidentally
cycle the On/Off power switch, there is an 8-second delay before power shuts
down. If you do wish to power down, do nothing during this 8 seconds or touxh
the ventilator screen to confirm the power down.

2.2.7 Pre-use Testing


Please read the following instructions in conjunction with the information
on Compliance compensation contained in the Installation section 2.3.4.2
of this manual.
Refer to recommendations of your local professional association
regarding checklists for pre-use testing of ventilators.

At the end of the Pre-use check, you are given the option to do a full
system test. Although not necessary to do each time the machine is
turned on, you should perform the full System Test daily.

The patient airway flow sensor must be installed the patient breathing
circuit (see section 2.2.17 for positioning) and the associated sensor
tubing must not be trapped, kinked, split or damaged in any way to
ensure correct performance.

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After the ventilator powers on, you will see


the startup screen. This screen lists the
model number of your ventilator and the op-
tion to perform or skip the Pre-Use Test for
Compliance Compensation (Figure 39).

Figure 39 - Pre-use Opening Screen


at Power-On

If you select No to skip the Pre-Use


Compliance test, you will see a confirmation
screen (Figure 40).

Figure 40 - Verification Screen if you


choose to skip the Compliance Check

If you select Yes to perform the Pre-Use


Compliance test, you will see the Start
screen for the test (Figure 41). Follow the
instructions on the screen to perform the
Pre-Use Compliance test.

After you have set the Bag/Vent switch to


Vent, you will see 1 of 2 screens, depend- Figure 41 - Start Screen for the
Pre-Use Tests
ing on how the gas analyzer is set-up by the
service engineer during system installation.
Shown at the top of the next page, the left
screen is displayed if the analyzer is scav-
enged. The right screen is displayed if the
analyzer exhaust is returned to the circle.

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Figure 42 - Pre-use Occlusion Tests Screens

The on-screen instructions prepare for performing three ventilator tests.


PEEP Valve Calibration
Calculation of system dead space (Compliance)
Leak Test

Figure 43 - Leak Test Screens

Having measured the dead space at the start, the leak test displays the upper
left screen and concludes with the upper right screen after 20 seconds. Next,
set the Absorber to Bag to complete the Compliance Test.

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.2.2.7.1 System Check


After the leak check is completed, you are asked to
perform the system check (Figure 44). The system
check verifies all areas of the breathing system that
were not tested during the leak or compliance check,
such as the APL valve.
Figure 44 - Perform System
If you select NO to skip the system check, you will
Check Screen
see the confirmation message (Figure 45). Select
Perform the System Check to carry out the test or
select Exit Checks to skip the System Test.

If you select YES to perform the System Test, you


will see the first of three instruction screens shown
below. Follow the instructions displayed on each
screen to perform the System Test. Set the controls
as instructed and carry out the manual test as in-
structed making the necessary observations that all Figure 45 - System Test
Confirmation Screen
components are working correctly. Select Confirm
when you have completed each set of instructions.

Figure 46 - System Test Screens

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After you have verified that the manual system works, you can test the ventila-
tor in the Adult mode using an Adult flow sensor at nominal settings of:
TV 500mL
12 BPM
I:E 1:2.0

Or, you can test the ventilator in the Pediatric mode with the pedi sensor using
the default settings:
TV 150mL
15 BPM
I:E 1:2.0

To test the ventilator:

1. Set up the system for the type of sensor/patient mode you will test.
2. Connect a breathing bag or a test lung to the breathing circuit.
3. Press the Trak Wheel when ready.
4. Set the Bag/Vent switch to Vent.
5. Ensure that the Bag and Bellows are full.
6. Observe the displayed wave form and expired volume are consistent with
the expected result. Other tests can be carried out at the users discretion.

When this test is completed satisfactorily,


you will see the message Compliance
Check Passed: <Date> <Time> above the
Activity area on the Standby screen. For
System Check information, see Page 2 of
the System Information (on the Setup >
Configuration menu).The system is ready
for use.

Figure 47 - Compliance Check


Passed Message

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2.2.8 Pre-Use Test Error Messages


If errors are encountered during the Pre-Use Test, one of the following eight
error messages will be displayed. These messages indicate what may have
caused the error and suggest a possible solution.

Error 01
The patient pressure is too high (>4cmH2O)
to begin the test.

Figure 48 - Pre-use Test Error


Message (01)

Error 02
If the absorber is not set to Vent when
starting the test, the system reminds you
(Figure 49).

Figure 49 - Pre-use Test Error


Message (02)

Error 03
The Fresh Gas is too High. Reduce the
fresh gas flow and restart the system test.

Figure 50 - Pre-use Test Error Message (03)

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Error 04
The absorber is not installed correctly. Pull
the absorber forward a few centimeters.
Check that no materials are between the
absorber and main frame. Push absorber
firmly back in position. You will hear a click
when it is engaged.

Figure 51 - Pre-use Test Error


Message (04)

Error 05
The gas supply pressure is too low.
Check the pipeline/cylinder gauges for
the correct gas supply.

Figure 52 - Pre-use Test Error


Message (05)

Error 06
The bellows are empty. Fill the bellows
and select Confirm to continue.

Figure 53 - Pre-use Test Error


Message (06)

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Error 07
If the system has a leak that is too large or
if the circuit is not occluded correctly, the
test will fail at this point.

This error can be caused by fitting


a Re-Breathing bag to the Y
connector instead of occluding the Figure 54 - Pre-use Test Error
circuit on the plug provided on the Message (07)
absorber.

Error 08
If a leak is detected, the causes listed on the
screen are possible places to check. Note that
these are not the only possibilities. Small holes
in the sensor tubing and cracks in breathing
circuits may also cause leaks.
Figure 55 -Pre-use Test Error
Message (08)

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2.2.9 Absorber Not Installed


If the absorber is not correctly installed
(pushed back securely towards the bellows),
an error message (Figure 56) is displayed
and the ventilator switches to Standby mode.

If you see this message,


1. Pull the absorber forward.
2. Check that there are no materials
trapped between the absorber and the
main body of the system. Figure 56 - Absorber Not Fitted
Message
3. Push the absorber fully back so it is
snug against the system. You will hear a
click when the absorber is engaged.
4. After the absorber is correctly installed,
set the absorber to Bag when you see
the Set Absorber message.The Normal
screen is displayed.

Figure 57 - Set Absorber Message

2.2.10 Fresh Gas


Fresh Gas Flow Compensation has several effects on the operation of the
ventilator. In normal conditions, the volume added to each breath due to
fresh gas flow / time is deducted from the driving gas volume that is used to
compress the bellows. This gives a volume at the Y piece that is constant.

In some situations when the normal correction cannot be completed, the


ventilator alarms. The screen displays a message instructing you how to
proceed when correction cannot be made by reducing drive gas.

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2.2.11 Standby/Bag Modes

Turn the absorber switch to VENT


to start the Ventilation mode. The
screen displays VENTILATION.

Figure 58 - Absorber Switch Set to VENT

Turn the absorber switch to BAG to


activate the Bag mode. The screen
displays BAG.

Figure 59 - Absorber Switch Set to BAG

After three breaths are detected, the ventilator switches from Standby to Bag
Mode. When a breathing pattern is identified, the Apnea detector activates and
will detect a failure to breathe after the user-defined period (Apnea Alarm set-
ting). When the ventilator detects that a patient is breathing spontaneously, the
ventilator switches from STANDBY mode to Bag mode and BAG is displayed
on the screen. In this condition, all relevant alarms are active. The alarms not
in use at this time are:
Pressure Low
MV Low

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When the absorber switch is set to VENT, the


screen displays VENTILATION and the ventila-
tor operates in the selected mode.
While the ventilator is in BAG mode, all
monitoring is still active and alarms are active
with the following exceptions:
The PEEP Error alarm is not active in the
BAG mode.
Figure 60 - Standby Screen
The Pressure High alarm is only active in
the BAG mode.
If an alarm is active in STANDBY, the audio alarm will become active
immediately upon entering BAG mode.
The MV alarm is active after the ventilator enters the BAG mode and
retains settings from previous ventilation. If the MV alarm is triggered,
you can select AUTOSET to reset alarms limits.
The BPM alarm (in BAG mode) will only become active after the
AUTOSET button is pressed. It will not be active before this time.
To cancel these alarms and return to Standby
mode, press the End of Case button on the
screen, then select an option.

The following is a summary of the alarm


messages under various conditions.

If the tidal volumes are at mid to high levels, the


Fresh Gas Too High message is displayed. Figure 61 - Fresh Gas Too High
To correct this alarm, you can change either Screen (01)
the I:E ratio or fresh gas setting. The I:E ratio is
highlighted in red (see Figure 61). A message
to reduce the fresh gas is displayed in the alarm
panel (in Figure 61, the suggested value is 15
lpm).

If the tidal volumes are low (>1.7 L/min), the


allowable fresh gas flow will be low, and where
the suggested calculated fresh gas flow is more
than 3 lpm, the alarm section displays Reduce Figure 62 - Fresh Gas Too High
Screen (02)
Fresh Gas.

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In some cases, at high fresh gas flow, the


calculated I:E would be outside the allowed I:E
range. For example, the maximum I:E value
allowed on the ventilator is 1:5.0. If the calculated
I:E should be set to 1:7 (which is outside the
allowed range), then your only option is to reduce
the fresh gas flow. Thus, the I:E will NOT be
forced red, and will be left at the set value. Figure 63 - Fresh Gas Too
High (03)
2.2.12 I:E Setting
In the case where the I:E is forced to a value
displayed in red, select I:E ratio button, the
suggested value, rather than the previously
set value will be displayed. By confirming the
suggested value, the I:E ratio will be changed to
allow the required level of fresh gas to be used.

Figure 64 - Fresh Gas Too


High (04)
If nothing happens during the first 12 seconds
of the alarm, the suggested I:E value will be
implemented. The alarm will continue to sound.

Figure 65 - Fresh Gas Too


High (05)

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2.2.13 Oxygen Calibration


The Oxygen Calibration option allows you to adjust the displayed oxygen con-
centration to match the concentration measured by the probe. Normally, this
concentration is 100% pure oxygen.

Oxygen Calibration is only possible if the ventilator is in the Standby


mode and a probe is connected.

1. Verify that Oxygen is selected as monitored parameter.


2. Select the Setup button, then select Oxygen Calibration.
3. Expose the probe to 100% pure oxygen flow or 21% room air.
4. Adjust the displayed value to 100% or 21% (as applicable). Turn the Trak
Wheel, then press it to confirm the setting.
5. Press the Trak Wheel again to start the calibration. This process takes
approximately one minute. Progress time is displayed on the screen.
6. When the calibration process is complete, return to the main screen.
7. Stop the flow of pure oxygen and expose the probe to room air for a few
minutes. The oxygen concentration should nominally read 20.9+/-0.5%.
To prevent inaccurate calibration, the ventilator will check to ensure
the correct percentage of oxygen is present for the selected calibration
point.

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2.2.13.1 O2 Calibration with A.C.G.O. System


The oxygen calibration allows adjustment of the displayed oxygen
concentration to match the concentration measured by the probe. This
concentration is normally 100% oxygen.

Calibration is only possible if the Oxygen Percentage Parameter is


selected and a probe is connected.

1. Verify that O2% is selected as a monitored


parameter in the CGO position.
2. Switch to A.C.G.O modem. You will see the
screen shown in Figure 66.
3. Place the O2 probe in the blue T piece and
attach to A.C.G.O.
4. Set the flowmeter to a flow of 2-3 Lpm O2. Figure 66- A.C.G.O Screen
5. Select Setup, then select Oxygen Calibration.
6. Select 100% to start the calibration (Figure 67).
This procedure takes 60 seconds. Progress
time is displayed on screen.
7. Once calibration is complete the system will
return to the main A.C.G.O screen.
8. Turn down O2 flow to basal.
9. Remove O2 probe and T piece from A.C.G.O. Figure 67 - Oxygen Screen
10. Replace the O2 probe into the absorber and set
the A.C.G.O/C.G.O switch to C.G.O position, if
ventilation is required.

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2.2.14 The Measurements Menu

The Measurements Selection menu allows the operator to assign parameters


to any of the monitored parameter buttons.

The features available depend on the operating mode.

To select measurements for monitoring:

1. Select Setup on the Normal screen.


2. Select Configuration on the Setup menu.
3. Select Measurements on the Configuration
menu. The Measurements menu is displayed.
4. Highlight a measurement listed on the menu,
for example, highlight Fresh Gas. Figure 68 - Setup Menu
5. Press the Trak Wheel. The left button on
Parameters row is highlighted.
6. Highlight the button where you want to display
the parameter value.
7. Press the Trak Wheel to assign the
measurement (e.g. Fresh Gas) to the
highlighted button. Continue to select Figure 69 - Configuration Menu
parameters until you have displayed
the ones you want to monitor. You follow
the same process to remove a parameter
from a button.
8. Select Return to close Measurements
Selection Menu.
9. Select Return to close the Configuration Figure 70 - Measurements Menu
menu and display the normal screen.

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2.2.15 Adult and Pediatric Modes


There are two methods of patient mode selection
with the ventilator in BAG or Standby mode.

1. To select either Adult or Pediatric mode as the


patient mode at startup, press the Defaults
button. Select Adult or Pediatric from the Figure 71 - Adult & Pediatric
Patient Mode Menu. Menu

-or-
2. Press on the Adult/Pediatric button on the main screen to change the
current patient mode.
In either case, select the mode, then confirm the choice by pressing Return.

Ensure that you select the correct Patient Mode for the flow sensor type
(Adult or Pediatric) you will use to ventilate the patient.

The Patient Mode can only be changed while the ventilator is in BAG or
Standby mode, not in Run mode.

2.2.16 Auxilliary Common Gas Outlet (A.C.G.O.) Option

Figure 72 - A.C.G.O Port and Switch-


Locations Figure 73 - A.C.G.O Warning

The ventilator displays the warning A.C.G.O. while the auxiliary


common gas outlet is in use. If the A.C.G.O. switch is activated during
ventilation, the ventilator will continue for about 10 seconds before
switching over. If the ventilator is in Standby mode, the switch over is
immediate. To reactivate the ventilator, turn off A.C.G.O., switch to Bag
mode, then back to Vent mode.

100% oxygen calibration is NOT available when in A.C.G.O. mode (see


Section 2.2.13).

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2.2.17 Types of Flow Sensors


Two flow sensors are available for use with the 700/900 Series Ventilators:
Adult Flow Sensor (PN10110090)
Pediatric Flow Sensor (PN 376-0561-00)

Figure 74 - Adult Flow Sensor (L) and Pediatric Flow Sensor (R)

For reference purposes in this guide, the word Sensor refers to the
adult flow sensor. Pedi Sensor refers to the pediatric flow sensor.

Use the adult flow sensor for TV over 300ml or in cases when you choose
to place the sensor at the absorber. When setting a tidal volume of less than
200 ml on the ventilator in Volume Control or SIMV-VC + PSV modes and the
patient type is adult, the patient type and sensor type boxes will be highlighted
amber on the screen (color systems only) when ventilation is on. It is strongly
recommended that the pediatric patient type along with the proper sensor
selection be made on the ventilator in this setting range.

Use the Pedi Sensor for TV less than 300 ml, where dead space or sensor
placement is a concern and when peak flow rates are below 30 lpm. This sen-
sor can only be used at the patient wye-piece.

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2.2.18 Sensor Placement


The Adult Sensor can be placed at two locations in the circuit at the patient
or at the absorber expiratory port. The Pedi-Sensor can only be used at the
patient wye and when the ventilator is in the Pediatric mode.

The sensor measures inspired and expired flow into and from patient, it
also measures pressure in patient airway.

1. Place the ventilator in Bag mode or Standby.


To place the ventilator in Bag mode, turn
absorber switch to Bag.
To place the ventilator in Standby mode,
place the absorber in Bag mode, then
press End Of Case on the screen.
Figure 75 - Standby Mode
Choose one of the options to place
ventilator into Standby mode.

2. Press the Sensor button located below the Alarm panel on the screen.

You can only change the sensor placement in Standby mode, not in Run
mode.

3. Select Sensor At Patient or Sensor At


Absorber for an Adult patient. Select Pedi
Sensor At Patient for a Pediatric patient.
Press the Trak Wheel to confirm your selection.

Ensure that you select the correct Sensor


Figure 76 - Sensor
Placement setting for the flow sensor type
(Adult or Pediatric) you will use to ventilate Placement Screen
the patient.

4. Turn the absorber switch to VENT to start the ventilator. When the adult
sensor is at the absorber expiratory port, the ventilator can only be run in
Volume Control and Pressure Control modes.

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Placing the sensor at the absorber has several implications for ventilator
operation.

There is no inspired volume measurement box. If this was previously


selected as a feature when the sensor is chosen to be at absorber, the box
is forced off the screen. The Inspired Volume feature is grayed out and
inaccessible.

The user cannot select to view spirometry graphs. Waveform Select is


grayed out and inaccessible in the menu. If the graph was previously
set to Flow/Pressure or Flow/Volume when Sensor at Absorber is
chosen, the graph must be pressure.

If the absorber position is changed and it is required that this change is


permanent, the user must either save current settings or save the hospital
default settings.

When the sensor placement is at the absorber. tidal volume may appear
higher than expected due to the effect of compressible volume in the
patient circuit.

5. When switching to the Vent mode from Standby, a sensor position check
is performed. If the sensor is not in the position that has been selected,
the message check sensors position (either at patient or at absorber) is
displayed.

The Pedi Sensor allows the use of supportive ventilation modes,


including SIMV-PC + PSV with certain models. The Pedi Sensor must be
placed at the patient wye piece.

When setting up the breathing circuit with a patient filter, ensure that
the sensor is not contaminated by moisture and that the patient circuit
doesnt produce a jetting effect on the sensor(s).

Position the patient airway flow sensor tubing with care. If the tubing
is pinched or cut, the ventilators volume monitoring may not function
properly.

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At Patient At Absorber

Figure 77 - Airway Sensor Placement - Sensor at Patient and Sensor at Absorber

The patient airway flow sensor must be correctly installed at either the
distal location in the patient systems expiratory limb or the proximal
end of the Y connector. If the sensor is installed incorrectly or the
sensor placement selection is incorrect, volume data will be inaccurate
and associated alarms, including the low minute volume alarm will not
function properly.

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2.2.18 The Waveform Select Menu


From the Waveform Select option, you
can view one of two Spirometry loops
(Pressure/Volume or Flow/Volume), an
Airway Pressure waveform or an Airway
Flow waveform. To select a waveform
display:
1. Select Setup.
Figure 78 - Waveform Select Options
2. Select Waveform Select.
3. Select the desired waveform display
using the Trak Wheel, then select Return.
In all modes, the airway pressure bar is shown on the left side of the trace
area. This bar shows the real time airway pressure. The peak value of the last
breath is also displayed.

Previous Peak

Real Time Pressure Level

Figure 79 - Airway Pressure Bar

2.2.19 Save a Spirometry Loop


After you select a spirometry waveform, the Store Loop option is displayed.

Figure 80 - Store Loop

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Figure 81 - Current Loop & Saved Loop Display

When you are satisfied that the patient is in a stable pre-operative condition,
you can save the next loop to be displayed.
1. Highlight the Store Loop button (Figure 80).
2. Select Confirm. A Saving message is displayed. The next loop will be
saved and identified by the time it was saved. This waveform is displayed
in red on the waveform area. You can save up to six loops, depending on
the ventilator model.
There may be a slight delay while the loop is saved. Do not select
Confirm again, during this delay.

2.2.19.1 Recall a Spirometry Loop


You can recall any stored loop by the time it was saved.
1. Highlight the Store Loop button.
2. Use the Trak Wheel or the up/down arrow buttons to scroll through the
saved loops, by the time saved.
3. Select Confirm to recall the loop.
4. Turn off the recalled loop by displaying Off on the Store Loop button.

Step 1: Highlight
Store Loop Step 2: Select a
button Loop by saved
time

Step 4: Turn
Off Saved Loop
Display

Figure 82 - Store Loop Options

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2.2.19.2 Example Spirometry Loops


2.2.19.2.1 Pressure/Volume Loops

Figure 83 - PEEP Loop Figure 84- Spontaneous Breathing Loop

Figure 85 - Bronchospasm
Loop

Figure 87 - Patient Breathing with Vent


Figure 86 - Kinked Tube (e.g. Lack of relaxation) Loop
Loop

2.2.19.2.2 Flow/Volume Loops

Figure 88 - Cuff or Laryngeal mask Leak Loop and Kinked Tracheal Tube Loop

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2.2.19.2.3 Pneumothorax during Laparoscopy - Diagnosis


& Treatment
Case Evolution
I. Intra-abdominal CO2 Insufflation
- Compliance drops
- Pplat increases
- ETCO2 increases sharply

Figure 89 - Intro-abdominal CO2 Insuffla-


tion Loop

II. Pneumothorax Occurs


- Compliance drops further
- Pplat increases further
- ETC02 increases more sharply
* (The occurrence of pneumothorax was
confirmed through fluoroscopy)

Figure 90 - Pneumothorax Occurs Loop

III. Treatment with PEEP


- Compliance improves
- Pplat decreases gradually
- ETC02 decreases

IV. Deflation of the abdomen

Figure 91- PEEP Treatment Loop

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2.2.20 Airway Pressure Waveform


The airway pressure waveform autoscales so that the amplitude is 80% of the
available height. The high marker is a number representing the upper limit of
the waveform. The zero baseline is a dotted line. When the pressure is greater
than or equal to zero, the waveform is blue and when it is less than zero, it is
green.
High Marker

Zero Baseline

Figure 92 - Zero Baseline

2.2.20.1 Airway Flow Waveform


The airway flow waveform autoscales so that the amplitude is 80% of the
available height. The pressure bar is still shown. The zero baseline is a dotted
line. Inspired flow to the patient is green and expired flow from the patient is
blue.

Expired Flow from


Patient Zero Baseline

Inspired Flow to
Patient

Figure 93 - Expired Flow from and Inspired Flow to Patient

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2.2.21 Ventilation Mode Menu


Refer to Section 2.1.3 for descriptions of the
available ventilation modes. Each mode enables/
disables options in the right column on the Mode
menu. The available options are displayed in black.

To select a ventilation mode:


Figure 94 - Ventilation Mode
1. Select the Mode button on the Normal screen
Menu
or the Mode option on the Setup menu.
2. Select the desired ventilation mode. A checkmark in the box next to the
mode name indicates that it is selected.
3. Select Return to display the Normal screen.
If no selection is made, after approximately 30 seconds the display
automatically returns to the main screen.

If you change a ventilation mode while the ventilator is operating (in VENT
mode), a prompt asks you to confirm or adjust the main parameter for the new
mode.

Figure 95 - Change Ventilation Mode Prompts

Select Accept or Cancel to confirm or bypass the suggested setting. You can
also change the setting using the Trak Wheel.
2.2.21.1 Pause
Pause is available in the Volume Control and SIMV-VC + PSV ventilation
modes. To select a percent pause:
1. Select Pause on the Mode menu.
2. Select the percent pause.
3. Press Return to confirm your selection.
4. Press Return again to display the Normal
Figure 96 - Pause Options
screen.
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You must select a Pause setting to display the Plateau Pressure


measurment.

2.2.21.2 Pause + Sigh settings


You can change the ventilation mode, where pause + sigh are not relevant (for
example, to Pressure Control), then upon returning to the Volume Control or
SIMV-VC + PSV mode, the previous pause or sigh setting will be active.

Compliance Measurement is displayed only in Volume Control, SIMV-PC+PSV


and SIMV-VC+PSV modes.

2.2.21.3 Cardiac Bypass


This selection represents the same standby function as End of Case, except
the case timer does not stop and measurement of flow in the patient circuit
does not bring the ventilator back out of standby.

To exit Cardiac Bypass, turn the absorber switch to VENT or deselect Cardiac
Bypass on the Ventilation Mode menu.

2.2.22 Setting Parameters


To set or change a parameter:
1. On the Normal Run screen, turn the Trak Wheel to highlight the desired
parameter, then press the wheel. The selected parameter is highlighted.
2. Turn the Trak Wheel clockwise to increase the parameter value or
counterclockwise to decrease it. The value will not increase above the
high pre-set limit or decrease below the low pre-set limit.
3. When the required value is displayed, press the Trak Wheel to confirm
your choice.

2.2.23 Alarms
The 700/900 series ventilator contains a number of pre-set and user-defined
alarms for patient and ventilator monitoring.

An audible alarm indicates an abnormal condition that may result in


injury to the patient or damage to the equipment. Always investigate the
cause of an alarm and take necessary measures to resolve the alarm
condition.

The high and low pressure alarms are important for patient safety.

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When an alarm is activated:


an audible warning sounds.
a flashing message appears in the alarm activity area of the display.
the alarm is added to the list of active alarms in the alarm area on the
screen.

Alarm Activity
Alarm Message Area

Alarms & Settings

Figure 97 - Alarm Screen

The active alarm is listed in the alarm activity area for a minimum of 30 sec-
onds. If the alarm condition is resolved during this time, the alarm is automati-
cally cleared from the list. If more than one alarm is activated, each new alarm
is added to the top of the list.

If an alarm activates while a menu is displayed on the screen, the alarm


will sound, but the alarm message is not displayed on the menu screen.
Return to the Normal screen to view the alarm message and resolve the
alarm condition.

If an alarm condition cannot be resolved, do not use the system.

Check alarms periodically at clinically suitable intervals. If the audible


alarm or visual indicator of any alarm function fails to activate during
any alarm condition, or fails to reset after the alarm has been cleared,
contact Spacelabs Global Technical Support for assistance.

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2.2.23.1 Alarms Summary


The available alarms are summarized in the table below. Each alarm is described in detail later in
this section.
Priority level, 1=Hi, 2=Med, 3=Low Alarm sound pressure range >65dB(A) <90dB(A)
ALARM RANGE/SETTING PRIORITY

Absorber Not Fitted Pre-set 1

Cal Error Pre-set 1

Comms Err. Pre-set. Internal communications error. 1

Low Supply Gas Pressure Pre-set. 35 0.5psig. 1

O2 Sensor Error* Pre-set 1

Pressure High* Pre-set. 10cmH2O to 70cmH2O. 1

Sustained Pressure* Pre-set. Less than 5cmH2O (adult) or 3cmH2O in (pediatric) change in pressure 1
per breath.

Vent Inoperative* Pre-set. System Failed. 1

Check Total Flow Pre-set (EFM only). 2

Fresh Gas Too High Pre-set. 2

O2 Supply Fail Pre-set. 2

PAW <-10cmH2O* Pre-set. 2

Battery Low pre-set. <15 minutes battery life remaining. Also visually as a decaying battery 2
symbol.

Mains Fail Pre-set. Mains electrical supply failure. 2

Setting Error Pre-set. Ventilatory parameter set out of range. 2

Fan Fail* Pre-set. 3

PEEP Error* Pre-set. 3

Sensor Error* Pre-set. 3

Sensor Not Detected* Pre-set. 3

Under Pressure* Pre-set. 3

Apnea* (Default) 30 seconds User Defined 15-60secs. 1

Low Oxygen User defined. 18% to 109%. 1

Press Limit User defined. 1

BPM High* User defined. 1BPM to 99BPM. 2

High Oxygen User defined. 19% to 110% 2

BPM Low* User defined. 0BPM to 98BPM. 2

Minute Vol. High* User defined. 1 l/m to 25 l/m adult. 1 l/m to 25 l/m pediatric. 2

Minute Vol. Low* User defined. 0 l/m to 24 l/m adult. 0 l/m to 24 l/m pediatric. 2

Pressure Low* User defined. 5cmH2O to 50cmH2O. 1

Do not set alarms to extreme values because those settings can cause the alarm
system to operate incorrectly.
Alarms marked with a (*) are inhibited for 20secs, when the ventilator mode is
changed. Refer to Alarms Summary.

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2.2.23.2 Pre-set Alarms


The following alarms are set at the factory.

2.2.23.2.1 Absorber Not Fitted Alarm


This alarm activates if the absorber is not correctly mounted to the system.
When this alarm activiates, ventilation stops. See Section 2.2.9 for more
information.

2.2.23.2.2 Cal Error Alarm


This alarm activates if the system cannot access the calibration files and can
not retained the data from a calibration sequence. In the rare occurrence that
this error happens in the field, the user should perform a calibration, which
should re-store the data, and clear the error. If the error does not clear, the
user should contact Spacelabs Technical Support.

2.2.23.2.3 Comms Fail Alarm


This alarm activates if there is an internal communications error between the
control and the monitoring systems.

2.2.23.2.4 Low Supply Gas Pressure Alarm


This alarm activates when the gas supply pressure falls below the pressure re-
quired for correct ventilator operation. As a safety precaution while this alarm
is active, the ventilator flow delivery system is prevented from trying to com-
pensate for the lack of supply gas by opening the flow control valves further.
This stops the large surge of flow that may otherwise occur if the supply gas is
suddenly re-applied, particularly when a bottled supply is changed.

If the supply gas pressure is reduced, the patient minute volume may be
reduced and injury to the patient could result. Do not use the ventilator
if the supply pressure cannot be maintained.

2.2.23.2.5 O2 Sensor Error Alarm


This alarm activates if the sensor is unplugged or faulty.

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2.2.23.2.6 Pressure High Alarm


In the Pressure Control mode, the high pressure alarm is 25% above the set
pressure. In Volume Control mode, SIMV-VC+PSV and Pressure Support
modes, the pressure high alarm limit is set via pressure limit setting on the
main screen. It is activated if one of the following conditions occurs:
The patient breathing system pressure rises significantly above that set
limit.
The patient breathing system pressure has not fallen after a pressure-
terminated breath has cycled into expiration.
Pressure cycling occurs in adult ventilation mode. (The pressure limit is
set and reached during volume ventilation.)

Due to the connection with the pressure limit control, it is possible


with some patients that the alarm may occasionally be activated when
pressure limiting at low pressures in pediatric mode.
The alarm is automatically cleared when the pressure falls.

2.2.23.2.7 Sustained Pressure Alarm


This alarm activates if the patient breathing system pressure does not go
through a pre-set absolute pressure change as a breath is delivered [Less
than 5cmH2O (adult) or 3cmH2O (pediatric) change in pressure per breath.].
Two failed breaths activate the alarm; two good breaths clear it. The pressure
changes must be in a positive and negative direction for each breath, and
therefore the alarm will be activated if there is a build-up of pressure.

2.2.23.2.8 Vent Inoperative Alarm


This alarm activates if an internal fault is detected.
The Vent Inoperative alarm indicates that the ventilator cannot provide
ventilation functions. Do not use the ventilator on a patient while this
alarm is activated.

Do not set alarms to extreme values that can cause the alarm system to
function incorrectly.

If the Vent Inoperative alarm occurs, contact a qualified technical


engineer.

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2.2.23.2.9 Check Total Flow Alarm (EFM only)


This alarm for the optional electronic flow meter activates in one of three in-
stances during ventilation:
1. if the EFM displays a gas flow as a dashed line.
2. if flow data from the EFM is not received by the ventilator for more than
45 seconds.
3. if the O2 fresh gas flow from the EFM is less than 100%.

This alarm is only active on systems that have the EFM installed.

2.2.23.2.10 Fresh Gas Too High Alarm


This alarm activates in two ways:
1. During compliance compensation, if fresh gas goes above basal flow.
2. During ventilation, if fresh gas is more than 65% of required tidal volume.

2.2.23.2.11 O2 Supply Fail


This alarm activates if the oxygen supply has failed. The ventilator will be
running on air takeover, if the air supply is available.

The system will also sound an alarm on the ventilator if the oxygen fails.

2.2.23.2.12 PAW <-10cmH2O


This alarm activates if the patient pressure is lower than 10cmH2O (sub-
atmospheric). You can disable this alarm on the Alarm Setup menu.

2.2.23.2.13 Power Fail and Battery Low Alarms


These alarms are indicated by a change in color of the LED adjacent to
the display. Under normal conditions the LED will be GREEN.

A few seconds after mains failure occurs, the Power Fail indicator is RED. If
the condition persists for more than one minute, the alarm is activated and the
LED remains RED.

To conserve power, the display is switched off while the Power Fail alarm is
activated. To restore power to the display, press a key or turn the Trak Wheel.
The ventilator continues to function normally, powered by its internal battery
for a minimum of 30 minutes. Typical operating time is a minimum of 60
minutes.

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When the internal battery charge is nearly exhausted and has less than
15 minutes of running capacity left, the Battery Low alarm is activated and the
Battery Low indicator flashes RED.

This is an estimated time. Actual time may be more or less than 15


minutes.

When mains power is restored, the Battery Low indicator may remain lit, as
the battery recharges. If the Battery Low indicator illuminates without a mains
failure, there may be a battery or charging fault. The ventilator will then have
no battery backup and must not be used until the fault has been repaired.

2.2.23.2.14 Setting Error Alarm


The setting error alarm is activated under the following conditions, where the
ventilator performance limits are exceeded:

The ventilator settings (BPM, I:E, TV) require a flow greater than 100
Ipm or less than 1.5 Ipm.
The internal feedback systems cannot accurately provide the values set.
If extreme control settings are used, the resulting combination of
patient compliance and resistance may cause the ventilator to exceed
its specification, as the ventilator feedback systems attempt to
compensate, but do not quite reach the selected settings.

2.2.23.2.15 Fan Fail


This alarm activates if there is a failure of the fan that is inside the ventilator.

2.2.23.2.16 PEEP Alarm


This alarm activates if the measured PEEP is more than 25% above the set
value, or above 5cmH2O, if PEEP is not set.

2.2.23.2.17 Sensor Error


This alarm is activated when pressures measured from the airway flow sensor
do not correspond to readings measured internally. Generally caused by
disconnected or blocked spirometry tubing.

2.2.23.2.18 Sensor Not Detected


This alarm is activated if there is no positive or negative flow detected from the
patient flow sensor.

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2.2.23.2.19 Under Pressure Alarm (PCV mode only)


This alarm is activated when the peak pressure is less than 80% of the set
pressure and greater than the lower pressure limit.

2.2.24 User Defined Alarms

2.2.24.1 Apnea Alarm


After an initial breath has been detected, the alarm is activated if the ventilator
ceases to record a tidal volume for the set apnea time (set under alarms
menu). This is the case when the system is selected to either BAG or VENT.

If apnea is registered for approximately 5 minutes while in BAG mode


and no flow is detected, the machine will automatically go into STANDBY.

2.2.24.2 Low Oxygen Alarm


Range: 18 % to 109 %
This alarm is activated when the monitored oxygen level falls below the set
level. You can disable this alarm. Contact Spacelabs Healthcare Technical
Support or your local Spacelabs representative for more information.

2.2.24.3 High Oxygen Alarm


Range: 19 % to 110 %
This alarm is activated when the monitored oxygen level rises above the set
level. You can disable this alarm. Contact Spacelabs Healthcare Technical
Support or your local Spacelabs representative for more information.

2.2.24.4 High BPM Alarm


Range: 1BPM to 99BPM
This alarm is activated when the monitored BPM exceeds the set level.

2.2.24.5 Pressure Limit Alarm


This alarm is activated when measured airway pressure is higher than
the pressure limit control. If pressure limit is changed to a lower value the
pressure limit and high pressure alarms are inhibited for 40secs.

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2.2.24.6 Low BPM Alarm


Range: 0BPM to 98BPM
This alarm is activated when the monitored BPM falls below the set level.

2.2.24.7 MV High Alarm


Range: 2 Ipm to 25 Ipm adult mode.
Range: 1 lpm to 25 lpm pediatric mode.
This alarm is activated when the monitored expired volume exceeds the
set limit. When the expired volume falls below the alarm limit, the alarm
immediately clears.

2.2.24.8 MV Low Alarm


Range: 0 Ipm to 24 lpm adult mode.
Range: 0 lpm to 24 lpm pediatric mode.
This alarm is activated when the monitored expired volume falls below the set
limit.

2.2.24.9 Pressure Low Alarm


The alarm is automatically cleared on the second breath that exceeds the
alarm limit, if it occurs within 20 seconds. The pressure low alarm is activated
if the pressure falls below the set PEEP + 5cmH2O for more than 20secs.

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2.2.25 Auto Alarms


You can choose to automatically set the alarm parameters at
any time while the ventilator is running. Select the AUTO SET
button when OFF is displayed on the button. The ventilator
requires parameters to stabilize, before the alarms can be set.
The set values are 25% of the current monitored value.
Except in the following cases:

Pressure where the minimum value is always 5cmH2O.


Oxygen where the minimum value is 18%.

If you change any of the user selectable parameters or


change the ventilator mode, the set alarms function will Figure 98 - Auto Set
be cancelled. The alarms are returned to the values Alarm Buttons
previously defined. When this occurs, the ventilator beeps
and a message is displayed on screen.

If you open the Set Alarms Menu while the auto alarms are set, the
previous alarm values are restored without warning.

The user can restore the previous set of alarm limits at any time by either
selecting Off in the auto box, or going into the Alarm Limits Menu and
making no changes.

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2.2.26 The Alarms Setup Menu


2.2.26.1 Set the Alarms
On the Alarms Setup Menu, you define the high and low ranges for the alarms
appropriate to the mode of operation and the patient.

High and low alarms are linked, so that a low alarm value greater than a
high alarm value cannot be set.

1. Select Alarm Setup button on the Normal screen.


2. Select Alarm Limits.
3. Select the alarm limit value you want to change and confirm your
selection. Values displayed in white text cannot be changed

Only those alarms that are relevant to the current operating mode are
displayed.

Figure 99 - Alarms Limits Options

4. Press the up/down arrows or turn the Trak Wheel clockwise to increase or
counterclockwise to decrease the value.
5. When the desired value is displayed, press the Trak Wheel or press
Confirm to select the value.
6. Select Return to close the screen and return to the alarm options.

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2.2.26.2 Alarm Mute


You can mute alarms for up to a maximum of 2 minutes by pressing the Mute
button.

2.2.26.2.1 Set the Alarm Mute


Time
1. Select the Alarm Setup button.
2. Select Mute Time.
3. Select the desired amount of time to mute
the alarms. A checkmark in the box next
to an option indicates that it is selected.
4. Select Return to close the menu.

Do not use the ventilator if the alarm


mute button will not silence alarms.

Figure 100 - Mute Time Options

2.2.26.3 Set the Apnea Time Alarm


1. Select the Alarm Setup button.
2. Select Apnea Time.
3. Select the desired amount of time to
trigger the Apnea alarm. A checkmark in
the box next to an option indicates that it
is selected.
4. Select Return to close the menu.

Figure 101 - Setting Apnea Time

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2.2.26.4 Selecting/Deselecting PAW <-10cmH2O

1. Select the Alarm Setup button.


2. Select PAW <-10cmH2O.
3. Select or deselect PAW <-10cmH2O. A
cross in the check box indicates that it is
selected.
4. Select Return to close the menu.

Figure 102 - PAW <-10cmH2O Option

2.2.27 The Defaults Menu

From the Defaults menu, you can:


save the current settings for later
reuse.
set hospital defaults.
select previously stored settings.
change setting names.
Figure 103 - Defaults Menu

Settings and Hospital Defaults can be stored in Adult and Pediatric


patient modes under the same name. Before you select Settings or the
Defaults, select the correct patient mode (Adult or Pediatric).

Certain options on the Defaults Menu are password protected. Contact


Spacelabs Healthcare Technical Support or your local Spacelabs
representative for more information, if needed.

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2.2.27.1 Save Hospital Default Settings


This menu option allows you to the change the default start up settings
as Hospital Default Settings. This option is password protected. Contact
Spacelabs Healthcare Technical Support or your local Spacelabs
representative for more information.
To change the Default Settings:

1. Select the Defaults button.


2. Select Save Hospital Defaults.
3. Enter the password one letter at a time using the Trak Wheel. Turn the
Trak Wheel clockwise to move through the alphabet from A to Z and
then through the numbers 1 to 0. To insert a space, use the under-score
character ( _ ). Press the Trak Wheel to enter the character and advance
to the next space.
4. When you have entered the complete password, press the Trak Wheel to
store the current ventilator parameter settings as the hospital default or
start-up settings.

2.2.27.2 Save and Recall Settings


You can save and recall up to seven adult and pediatric ventilator settings
configurations, including all user-settable parameters and alarm limits.

You can store parameter settings in Adult and Pediatric patient modes
under the same name. Before you select Settings or the Defaults, select
the correct patient mode (Adult or Pediatric).

When recalling previously saved settings, verify that the selected


settings and alarm limits are clinically appropriate for use.

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2.2.27.3 Change Names

You must define at least one user name before you can save settings.

1. Select the Defaults button.


2. Select Change Names.

Figure 104 - Change Names Screen

3. Highlight a blank line or a settings name by turning the Trak Wheel.


4. Press the Trak Wheel to highlight the first space or character which is
displayed in Red.
5. Turn the Trak Wheel clockwise to move through the alphabet from A to
Z and then through the numbers 1 to 0. To insert a space use the under-
score character ( _ ).
6. Press the Trak Wheel when the desired character is displayed to enter the
character and move the cursor on to the next space or letter.
If you enter the wrong character and have already pressed the Trak
Wheel, you must start over with step 1. You cannot go back to change
the character.

7. Repeat steps 5 and 6 until the settings name is complete. You must enter
a total of 10 characters or spacesto complete the name. Press the Trak
wheel at the 10th character to save the name.
8. Repeat steps 3-7 to enter more names for the settings or to change a
name previously entered.
9. Select Return to display the Default Menu.

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2.2.27.4 Save Current Settings


1. Select the Default button.
2. Select Save Current Settings.
3. Highlight a settings name on the
screen.
4. Press the Trak Wheel to initiate the
save. A message is displayed stating
the setting (Adult or Pediactric) and the
saved name.
5. Select Return to display the Defaults Figure 105 - Save Current Settings
menu. Menu

2.2.27.5 Recall Settings


1. Select the Default button.
2. Using the Trak Wheel, select Recall Settings
3. Highlight a settings name on the screen.
4. Press the Trak Wheel to recall the settings. A message ise displayed
listing the mode (Adult or Pediatric) and the recalled settings name.
5. Select Return to display the Defaults menu.

After you recall settings, verify that the settings displayed on the screen
are correct.

2.2.27.6 Changing/Entering New Password


1. Select the Default button.
2. Select Save Hospital Defaults.
3. Select Change Password. Enter old
password and Confirm your entry.
4. At the prompt, enter the new password
and reenter it at the prompt, then
Confirm.
Figure 106 - Change Password
5. The new password is saved. Option Selected

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2.2.27.7 Configuration
When you select Configuration, the following menu is displayed:

Figure 107 - Configuration Menu

If you have the optional Electronic Flowmeter (EFM) installed, the


Backlight is not available.

2.2.27.8 Service Mode


The Service Mode options allow qualified technical engineers to access
certain setup and configuration modes, that are used after installation, compo-
nent repair / replacement and system validation. These options are password
protected. Contact Spacelabs Healthcare Technical Support or your local
Spacelabs representative for more information.

2.2.27.9 System Information


This two-page list shows details about
the ventilator status. Page 2 displays O2,
N20 and Air consumption information
for the case, if the system has the EFM.
To display page 1 and 2 of the System
Information:
Figure 108 - Example System
1. Select Setup. Information Screen, Page 1
2. Select Configuration.
3. Select System Information.
4. Touch the screen to display the second page.
5. Touch the Home button to return to the Run/Standby screen.

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2.2.27.10 System Audit Trail


This function is password protected. To access system audit
information, contact your local Spacelabs Healthcare representative.

The system audit function stores events about the machine and the ventilator,
including:

When unit was powered ON/OFF.


When unit was last re-programmed.
When the Ventilator mode was changed.
Pre-use system check information.
The Compliance value used for a new test, or recalled from the last test.
Recording of any pre-use attempts that failed.
The Bag/Vent switch position.
Start of case/End of case with case time.
Any ventilator settings change.
Any new alarm that has been generated.

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2.3 Installation

Cautions

An explosion hazard could occur if this equipment is used with flammable


anesthetic agents such as ether or cyclopropane. To avoid the risk of
explosion, use this equipment only with anesthetic agents that comply with the
requirements on non-flammable anesthetic agents in the IEC standard 60601-2-
13 Particular Requirements for the Safety of Anesthetic Machines.

Use of a driving gas other than oxygen or MED AIR may damage the ventilator
and will cause inaccurate operation, resulting in potential injury to the patient.
Do not use any other driving gas.

The performance of this equipment may be adversely affected by extremes of


temperature. The equipment should not be used if the ambient temperature is
below 10oC (50oF) or above 40oC (104oF).

The use of antistatic or electrically conductive breathing tubes and high


frequency electric surgery equipment may cause burns and is therefore not
recommended in any application of this machine. The ventilator is not suitable
for use with flammable anesthetic agents such as ether and cyclopropane and
therefore the use of antistatic breathing tubes and face masks is in any case
unnecessary.

This equipment may be damaged if the gas supply pressure is too high.
The ventilator must only be connected to gas pipeline supply lines that are
installed with pressure relief valves that limit the supply pressure to less than
700kPa/101.5psi.

The ventilator may be adversely affected by the operation of equipment such


as high frequency surgical (diathermy) equipment, defibrillators or short-wave
therapy equipment in the vicinity.

Connection of equipment to the auxiliary mains socket outlets may increase


leakage currents to values exceeding the allowable limits.

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Cautions Continued.

Connection of the equipment to the socket outlets will increase leakage currents.
It is the users responsibility to ensure compliance to IEC 60601-1-1 (collateral
standard for electrical medical systems). In the USA, equipment connected to
the socket outlets must comply with UL 60601-1 and the total sum of the system
leakage current shall not exceed 300 micro amps. It is the USERs responsibility
to ensure compliance with the above standard and that the leakage current limits
are not exceeded.

When using external patient circuits, there is a possible risk of high pressure.

To preserve battery life, never store the ventilator with its battery discharged. Do
not store or use the ventilator in close proximity to heat sources of any kind.

In the event of a mains electrical power failure when the ventilator is running
from its internal battery, do not remove the mains plug from the mains supply
as this would prevent the immediate resumption of normal operation when the
mains power is restored.

Excessive electronic noise caused by poorly regulated devices may interfere


with the proper functioning of the ventilator. To avoid this, do not connect the
ventilator to the same mains supply outlet as electrically noisy equipment
such as electrocautery units. Do not use a mains extension lead to connect
the ventilator to the mains electrical supply. Normal operation of all equipment
should be verified in your configuration before clinical use. If interference
is encountered, ensure all equipment is connected following manufacturers
recommendations.

The driving gas is discharged through the port on the rear panel of the
ventilator. This port must be completely free of any obstruction and
should have nothing connected to it. The exhaust gas is oxygen or MED
AIR and does not contaminate the environment.

A negative or positive pressure applied to the EXHAUST port of the bellows


assembly results in positive pressure in the patient breathing system. The
scavenging system must therefore not generate more than 5cmH2O of positive or
negative pressure when connected to the ventilator.

The use of an AGSS to EN 740 1999 is recommended. Do not connect a PEEP


valve to the EXHAUST port of the bellows base. This will increase the pressure
inside the bellows and cause it to detach from the base, resulting in a serious
malfunction. Any problem arising from an improperly functioning scavenging
system is solely the responsibility of the user.

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2.3.1 Pre-Use Checks


Prior to connecting the ventilator to a patient, run the unit to verify that it is
functioning correctly. Before using the ventilator, check that all connections are
correct and that there are no leaks.

1. Switch on the mains power supply.


2. Check that the audible alarm sounds at switch on.
3. Select and carry out the procedure for pre-use tests. This will perform the
compliance test and leak test the system.
4. Follow the on screen instructions.

Other alarms may also be activated, i.e., the sustained pressure.

Prior to connecting the machine to a patient carry out the pre-use


check to verify correct alarm operation. To verify the O2 alarm, set the
flowmeters to give a concentration of 50% oxygen. Using the controls on
the oxygen monitor panel, set the low oxygen level to 60%

Injury to the patient may result if a faulty ventilator is used. If the


ventilator should malfunction, do not use it. Refer to the Troubleshooting
section in this manual for help. If the malfunction cannot be rectified,
contact an authorized Spacelabs Healthcare technical engineer for
assistance or return the ventilator to your local representative.

If a ventilator alarm condition is ignored, injury to the patient may result.


Always check the alarms before connecting the ventilator to a patient.
If the audible alarm or the visual indicator of any alarm function fails to
activate during an alarm condition, or fails to reset after the alarm has
been cleared, do not use the ventilator. Contact an authorized Spacelabs
Healthcare technical engineer for assistance.

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Pre-Use Cautions

The oxygen monitor needs at least 10 minutes to stabilize after it has been
turned on. The oxygen sensor should always remain plugged into the machine to
ensure that it is ready to use.

Do not disassemble or modify the patient flow sensor.

If the gas sample line is not in use on the adult flow sensor, then replace white
cap on the port. The Pedi Sensor does not have a gas sample port.

The adult patient flow sensor must be correctly installed at either the distal
location in the patient systems expiratory limb or the proximal end of the wye
piece. The Pedi Sensor can only be installed at the patient wye piece. If the
sensor is installed incorrectly, volume data will be inaccurate and associated
alarms, including the low minute volume alarm will not function properly.

Position the patient airway flow sensor tubing with care. If the tubing is pinched
or cut, the ventilators volume monitoring may not function properly.

Upon receipt of new machines, you should sterilize/clean all parts of the machine
before use.

Periodically check and maintain the equipment to ensure proper operation.

Prior to connecting the machine to the patient, carry out the pre-use check to
verify correct alarm operation. To verify the O2 alarm, set the flow meters to
give a concentration of 50% oxygen. Using the controls on the oxygen monitor
panel, set the low oxygen level to 60% and verify the oxygen low alarm operates.
Set the high oxygen alarm level to 40% and verify that the oxygen high alarm
operates.

Always perform the pre-use check procedures for volume sensing functions
after cleaning or replacing the volume sensor.

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2.3.2 Discharged Battery


If the internal battery is fully discharged, the power failure alarm will not func-
tion. Charging the battery for 2 hours from a discharged state will allow a
minimum of 2 minutes of continuous audible alarm. The audible alarm should
be verified before returning the unit to service.

A discharged battery takes approximately 8 hours to fully charge. A fully


charged battery in serviceable condition will run the ventilator for a minimum of
30 minutes. Typical operating time is a minimum of 60 minutes.

To preserve battery life, never store the ventilator with its battery
discharged. Do not store or use the ventilator in close proximity to heat
sources of any kind.

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Exchanging Bellows Units

Figure 109 - Installing the Bellows

A Adult Bellows Housing


B Adult Bellows

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2.3.3 Installing the Adult Bellows

1. Remove the bellows housing by twisting it gently counterclockwise until


the bayonet tabs are free, then lift the housing from the base.
2. Mount the bellows.
3. Push the bellows housing down over the bellows, then twist it gently
clockwise to engage the bayonet tabs.

At pressures above 10cmH2O differential positive pressure, the bellows


may be dislodged from the mounting ring, resulting in a dangerous
malfunction of the ventilator. Do not exceed the stated pressure.

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2.3.4 Pre-use Test


2.3.4.1 Fresh Gas
Fresh gas (FG) flow adds to the delivered Tidal Volume (TV) during the
inspiratory period. To compensate, the delivered volume must be reduced.
The formula for this reduction is:

For example let

Therefore

2.3.4.2 Compliance Test


Compression of gas in the dead space within the breathing system reduces
the tidal volume delivered to the patient. In an ideal ventilator, the Set TV
would be the volume of gas that is delivered to the patients lungs. This cannot
be achieved because the anatomy of the patient is unknown. However, the Set
TV can be accurately delivered from the catheter mount, thus reducing Set TV
errors to a minimum.
To calculate the effect of breathing system compliance on the delivered
TV, it is necessary to measure the capacity or compliance (Cs) of the
system. This can only be done as part of a pre-use check procedure.

1. Switch the unit ON. The compliance prompt is


displayed.
The patient airway flow sensor head must
be in the patient circuit to perform the
compliance compensation test.

2. Select Yes at the Compliance prompt and


follow the instructions on screen. Figure 110 - Compliance
Prompt

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The ventilator delivers a breath of known volume to the breathing circuit,


records the pressure (cmH2O) achieved and verifies that a leak is not present.

3. The dead space is calculated as follows:

This value is retained in memory until the ventilator is switched off or retested.

4. When the ventilator is set to use on a patient and when the ventilation
is stable, the total compliance of system and patient (Ct) is measured.
The TV can then be increased to compensate for the volume lost due to
compression within the breathing system. The increase in tidal volume is
calculated by the following formula:

For example:
A system test measurement at a TV of 200ml provided a pressure rise of
25cmH2O.

Running the ventilator on a patient with a set 500ml TV provided a peak pres-
sure of 20cmH2O.

To calculate the increase in TV:

The 735ml is the actual ventilator output into the breathing circuit to provide
500ml at the catheter mount. The value must be recalculated every time
volume-controlled ventilation starts.

Use the same length of patient circuit that you will use on the patient to
calculate TV.

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2.4 Routine User Maintenance

Lethal voltages are present within this equipment when it is connected


to the mains electrical supply. Do not remove any of the ventilator covers
or panels. Refer all repairs and servicing to an authorized Spacelabs
Healthcare technical engineer.

2.4.1 Monthly Check


2.4.1.1 Control Unit
1. Connect the mains electrical power.
2. Turn the ventilator ON.
3. Disconnect the mains supply and verify that the MAINS FAIL alarm
activates.
4. Reconnect the mains electrical power and verify that the alarm resets.
5. Disconnect the O2 and MED AIR hose and turn off the O2 cylinder. The
SUPP GAS LOW alarm should activate.

Injury to the patient may result if you use a faulty ventilator. If there
is any ventilator malfunction, do not use the ventilator. Refer to the
Troubleshooting section for help. If the malfunction cannot be rectified,
contact an authorized Spacelabs Healthcare technical engineer or return
the ventilator to your local distributor.

2.4.2 Six-Month Check


2.4.2.1 Bellows
Each time the bellows assemblies are opened for cleaning, carefully inspect
all visible parts and replace any damaged components. Bellows material dete-
riorates with age and use, and should be examined every six months.

2.4.3 Other Maintenance


Occasionally, maintenance may be required on items that are not covered by
periodic routine maintenance tasks.

It is recommended that annual maintenance checks are performed by an


authorized technical engineer.

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2.4.4 Cleaning and Sterilization


Ingress of liquid into the control unit may damage the unit or injure
personnel. Ensure that no liquid enters the control unit, and always
disconnect the unit from the mains electrical supply before cleaning.
Do not clean the LCD screen with liquid.
Use only a dry, soft, lint-free cloth to clean the ventilator.

2.4.4.1 Ventilator Surfaces


Clean the outside surfaces of the ventilator by wiping them with a damp cloth
soaked in a mild detergent solution. Ensure that all residues are removed after
cleaning by wiping with a soft, dry, lint-free cloth. Never use abrasive cleaning
materials, particularly on the screen.

The ventilator surfaces are not scratch-resistant. Do not use abrasive


cleaning agents or you may damage the surfaces.

2.4.4.2 Patient Flow Sensor and Tubing


You can hand or machine wash the adult Flow Sensor and the Pedi Sensor.
Disinfect the flow sensors with a suitable antiseptic agent. Steam autoclav-
ing must not exceed 134oC. Both types of flow sensors can be sterilized with
ethylene oxide.
If autoclaving the sensor, follow autoclave manufacturers directions.
Temperature are not to exceed 134oC.
The blanking cap on the adult patient flow sensor is NOT autoclavable.

2.4.4.2.1 Sensor Tubing


Tubing may be cleaned with warm water and a mild soap solution (do not use
synthetic detergents or soaps). Rinse thoroughly in warm water followed by
distilled or filtered water.
You can sterilize tubing using the following methods:
1. Gas sterilization with Ethylene oxide, 54oC max. Follow by quarantine in a
well ventilated area to allow dissipation of residual absorbed gas.
2. Steam autoclaving at 134oC max.
Following cleaning and sterilization of patient airway flow sensor and
flow sensor tubing, ensure that no liquid is present in the tubes. Perform
Pre-use check.

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Figure 111 - Removing the Pop-off Valve

Figure 111 Key


A Bellows Housing E Bellows Base
B Bellows F Fixing Screws
C Pop-off Valve G O-ring
D Valve seat

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2.4.4.3 Bellows
Only the bellows base and the parts inside the bellows require
sterilization.
To avoid damage to the equipment:
Peak sterilization temperature must not exceed 134C.
Do not sterilize the control unit.
Gas sterilization should be followed by quarantine in a well-
ventilated area to allow dissipation of residual absorbed gas.
Follow the sterilization agent manufacturers instructions.
Pop-off valve must be autoclaved separately.

Perform the Pre-use Check procedures after cleaning and sterilizing the
bellows.
Unlike the current adult bellows cover, you cannot autoclave the
pediatric bellows cover. The pediatric bellows cover should never need
to be disinfected. However, if required, you can disinfect the pediatric
bellows cover using non-alcoholic surgical wipes. It is also possible
to gas sterilize (Ethylene Oxide, 54oC) and cold sterilize (Sporicidin,
Sonacide) the pediatric bellows. Do not use alcohol or chlorine-based
cleaning agents to disinfect the pediatric bellows cover.

Refer to Figure 111 as you perform the following steps.


1. Pull the absorber forward to disconnect the bellows base.
2. Loosen the two thumb screws retaining the bellows base and remove the
bellows base and housing from the control unit.
3. Remove the pop-off valve by unscrewing the three thumb screws, clean
and sterilize them separately.
4. Perform sterilization as specified in the table on the next page.

2.4.4.4 Pop-off Valve Seat


Refer to Figure 111 as you perform the following steps.
1. Remove the bellows housing and bellows.
2. Loosen the black thumbscrews and remove the pop-off valve.
3. Clean the valve seat carefully using a soft, lint-free cloth.
4. There is an O-ring (G) located in the bellows base (E), which provides
a seal with the pop-off valve. After cleaning, check that the O-ring is in
place, as the ventilator cannot function correctly without it.

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When refitting pop-off valve, ensure that thumb screws are evenly
tightened, finger tight only.

If the valve seat is damaged, the pop-off valve will leak and may cause
serious malfunction. Take care not to damage the precision-molded
surface of the valve seat while cleaning. Never use a hard object or
abrasive detergent. Use only a soft, lint-free cloth.

2.4.5 Methods of Sterilization


ITEM METHOD
Bellows Gas1, liquid2, autoclave3
O-ring Gas1, liquid2, autoclave3
Bellows Housing Gas1, liquid2, autoclave3
Bellows Base Gas1, liquid2, autoclave3
Pop-off Valve Gas1, liquid2, autoclave3
Control unit Do not sterilize
Patient Airway Flow Sensor Gas1, autoclave 134oC max
N.B The white plastic blank is not autoclavable.

Notes:
1. Ethylene oxide, 54C max.
2. e.g. Sporicidin, Sonacide.
3. Steam autoclave, 134C max.

Sterilize the bellows assembly periodically to minimize the risk of cross


infecting patients. Use a sterilization schedule that complies with your
institutions infection control and risk management policy. Only use
Spacelabs Healthcare-approved sterilization methods

If any foreign materials or liquids are trapped in the driving gas circuit,
or the pop off valve or the bellows base that could impair the valves
operation. Do not use the bellows assembly if you suspect that materials
are trapped. Have the assembly repaired by a qualified technical
engineer.

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2.5 Troubleshooting
The table below describes faults, probable causes and recommended corrective ac-
tions. If a fault persists, do not use the ventilator. Contact your Spacelabs Healthcare
service representative for assistance.
FAULT CAUSE ACTION
MAINS FAIL Power cable not connected. Connect power cable.
alarm activated
when ventilator Defective mains supply. Check supply.
switched on. Blown Fuse(s). Replace fuses.
Bellows cannot Breathing system hose Check hose. Replace the
be filled or disconnected or leaking. hose, if damaged.
collapses.
Broken bellows base. Replace bellows base.
Defective or detached Check bellows. Replace, if
bellows. damaged.
Damaged pop-off valve. Replace pop-off valve.

Missing or defective O-ring. Fit or replace O-ring.


Check patient connections.
Bellows Breathing system leak. Replace hose.
progressively
deflates, Open or defective pop-off Replace pop-off valve.
valve.
despite normal
fresh gas flow. Damaged pop-off valve Replace pop-off valve seat.
seat.
Replace O-ring.
Damaged bellows base
O-ring.
Replace bellows base.
Damaged bellows base. Check Patient connections.
Tidal volume Missing pop-off valve seat Fit O-ring.
incorrect or O-ring.
Use of incorrect flow sensor
inconsistent. or damaged or occluded
Partially detached or
defective bellows. flow sensor
Incorrect sensor selection
Damaged pop-off valve disc Check bellows. Replace if
or seat. damaged.

Replace pop-off valve disc


or seat.

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FAULT CAUSE ACTION


Irregular rate when Defective mains supply Change mains supply
electrocautery is outlet. outlet.
used.
Defective Check and repair
electrocautery. electrocautery.
PRESSURE LOW Disconnected or kinked Reconnect tube or
alarm activated but pressure pick-up tubing. remove kink.
ventilation normal.
Replace tube, if
damaged.
Tidal volume not Pressure limit set too Change pressure limit.
delivered and low.
PRESSURE CYCLING Remove obstructions.
Obstructions in
alarm activated. breathing system or
bellows drive gas.
SUPP GAS LOW alarm Incorrect drive gas Check drive gas supply
blinks on each breath. supply pressure. pressure.

Kinked or obstructed Reconnect hose or


drive gas supply hose. remove kink.

Replace hose, if
damaged.
Unwanted PEEP and Defective or poorly Adjust or exchange
overfull bellows. regulated scavenging scavenging system.
system.
Remove obstruction.
Partially obstructed
exhaust.

High Gas Flow.


BATT LOW alarm Defective or discharged Change battery.
activated. battery.
Replace, if defective.

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2.6 Performance Data


CONTROL/PARAMETER RANGE/VALUE
Input Voltage 100-240VAC
Frequency 50/60Hz
Current 500mA max.
Power Consumption 50VA
Input Supply Gas 40psig to 101psig at 120 lpm
Adult Bellows Size 1600ml
Adult Minute Volume 0.3 lpm to 25 lpm
Adult Tidal Volume 20ml to 1500ml
Pediatric Minute Volume 0.3 lpm to 25 lpm
Pediatric Tidal Volume 20ml to 1500ml
Rate 2bpm to 99bpm
I:E Ratio 2.0:1 to 1:5.0
Pressure Limit Control:
Adult 10cmH2O to 70cmH2O
Pediatric 10cmH2O to 50cmH2O
Maximum Working Pressure Range 5cmH2) to 70cmH2O
Altitude (self-compensating) 0 to 3,000m
Compliance (see note) Calibrated as maximum % of set
Adult volume
PEEP 3cmH2O to 20cmH2O

2.6.1 Notes on Performance Data

Both adult and pediatric compliance are increased by approximately


0.6ml/cmH2O when the ventilator bellows is separated from the control unit by
1.5m of 22mm tubing. This would be the case when the ventilator is installed
as part of a BleaseSirius Anesthesia work station where the bellows is behind
the absorber.

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2.6.2 Factory Default Settings


The tables below show the default settings at start-up. These settings were
defined at the factory. You can change these settings to suit your preferences
using the Save Hospital Defaults option on the Defaults Menu.

2.6.2.1 Volume Control Defaults at Startup


VOL RATE I:E PRESSURE MINUTE PRESS
(ML) (BPM) LIMIT VOL ALARM ALARM
(cmH2O) LO/HI LO/HI
ADULT 500 12 1:2.0 50 1/25 5/50
PEDIATRIC 150 15 1:2.0 30 1/25 5/30

2.6.2.2 Pressure Control Ventilation Defaults at Startup

VENT PRESS RATE PRESS ALARM MINUTE VOL


(cmH2O) BPM LO/HI ALARM
LO/HI
ADULT 15 12 5/18 1/25
PEDIATRIC 15 15 5/18 1/25

RATE MINUTE PRESSURE TRIGGER SUPPORT PRESSURE


ALARM VOL ALARM LIMIT
LO/HI ALARM LO/HI
LO/HI
ADULT 2/99 1/25 5/50 5 10 50
PEDIATRIC 2/99 1/25 5/30 5 10 30

2.6.2.3 SIMV VC+ PSV Defaults at Startup


SUPPORT Trig PRESS RATE MINUTE PRESS BPM VOL PEEP I-TIME
PRESS LIMIT ALARM VOL ALARM
(cmH2O) (cmH2O) LO/HI ALARM LO/HI
LO/HI

ADULT 10 5 50 2/99 1/25 5/50 12 500 OFF 1.7

PEDIATRIC 10 5 30 2/99 1/25 5/30 15 150 OFF 1.0

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2.6.2.4 SIMV PC+ PSV Defaults at Startup


SUPPORT Trig Ptot RATE MINUTE VOL PRESS BPM PEEP I-TIME
PRESS ALARM ALARM ALARM
(cmH2O) LO/HI LO/HI LO/HI

ADULT 10 5 15 2/99 1/25 5/18 12 OFF 1.7

PEDIATRIC 10 5 15 2/99 1/25 5/18 15 OFF 1.0

2.6.2.5 Pressure Support Defaults at Startup


PRESSURE FLOW SUPPORT PEEP
LIMIT TRIGGER PRESSURE
(cmH2O) (cmH2O)
ADULT 50 5 l/m 10cmH2O 0
PEDIATRIC 30 5 l/m 10cmH2O 0

2.6.2.6 Fixed Features


COMPLIANCE FRESH PEEP OXYGEN
GAS
VOLUME Meas/Set Meas
CONTROL
PRESSURE Meas/Set Meas
SUPPORT
SIMV-VC + PSV Meas/Set Meas
SIMV-PC + PSV Meas/Set Meas
PRESSURE Meas/Set Meas
CONTROL

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2.6.2.7 Mode Dependant Features


SIGH PAUSE PRESSURE PRESSURE BPM VOL/ I:E PRESSURE
SUPPORT SUPPORT FLOW LIMIT
TRIGGER PRESSURE

VOLUME Set Meas/Set Set Pressure


CONTROL Limit
PRESSURE ALWAYS ALWAYS Meas Meas Meas Pressure
SUPPORT Limit
SIMV-VC + ALWAYS ALWAYS Meas Meas/Set Meas Pressure
PSV /Set /Set Limit
SIMV-PC + ALWAYS ALWAYS Meas Meas Ptot
PSV /Set /Set
PRESSURE Set INSPIRED Set Set
CONTROL FLOW Pressure

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2.7 Associated Equipment and Accessories


Part Number Description
142UM000 BleaseSirius User Manual
140UM000 700/900 Ventilator User Manual
10110026 Adult Bellows Assembly Complete PEEP
10110016 Bellows Base Assembly
83034 Adult Bellows Only
83035 Adult Bellows Cover Only
80200026 Mains Cable UK 5m
80200027 Cordset Connector Lock UK
80200028 Mains Cable US 5m
80200029 Cordset Connector Lock US
80200063 Cordset Connector Hospital Grade
81027 Corrugated Hose (17mm/0.6 x 200mm/7.8)
ST2101 Corrugated Tubing 42 (22mm)
1070002 High Pressure Pipeline O2 NIST to mini Schrder
10700003 High Pressure Pipeline O2 NIST to mini Schrder UK
81014 High Pressure Pipeline O2 DISS to DISS US
940603 High Pressure Pipeline air DISS to UK Probe
S10638 Luer Female to Male Adaptor
S10639 Luer Male to Male Adaptor
10110102 BleaseSirius Patient Airway Flow Sensor Tubing Assembly (3m/9.8ft)
10110103 BleaseSirius Patient Airway Flow Sensor Tubing Assembly (6m/19.6ft)
12500014 Pop Off Valve Assembly
70300001 O2 Sensor

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2.8 External Communication Specification

2.8.1 Data Transmission Settings


RS232 Setup
Data Bits 8
Stop Bits 1
Parity None
Baud Rate 19200

Hardware handshaking not used.

2.8.2 Protocol

All messages will be standard ASCII


All messages from the ventilator will be prefixed with [
All messages will be delimited by a \r
All messages will be continuously re-transmitted.
There will be 4 basic message types as listed below. These messages
will be prefixed with the leading character to aid parsing.

Message Function
Set User set value
Measured Monitored measured value
Event Monitor events
Alarm Alarm status and message

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Section 2 - 700/900 Series Ventilators

2.8.3 Pin Connections


9-way D-socket 9-way D plug
Connections for external data monitoring Connections for manufacturers
diagnostics
Pin 1 not connected Pin 1 Reserved for manufacturers use
Pin 2 RXD: data input Pin 2 Reserved for manufacturers use
Pin 3 TXD: data output Pin 3 Reserved for manufacturers use
Pin 4 reserved Pin 4 Reserved for manufacturers use
Pin 5 GROUND Pin 5 RXD: data input
Pin 6 reserved Pin 6 Reserved for manufacturers use
Pin 7 reserved Pin 7 GROUND
Pin 8 reserved Pin 8 Reserved for manufacturers use
Pin 9 Not connected Pin 9 TXD: data output

2.8.4 Set Messages

[SBxx\r Set breaths/minute. xx = 2 digit bpm value


[SITxxx\r Set inpiratory time(hundredths of secs) xxx = 3 digit time value
[SIFxxx\r Set inpiratory flow (deciliters/minute) xxx = 3 digit time value
[SVxxx\r Set tidal volume. xxx = 3 digit value in centiliters
[SLxx\r Set pressure limit. xx = 2 digit value in cmH2O
[SRxx\r Set I/E ratio. xx = 2 digit value * 10
[SPExx\r Set PEEP value. xx = 2 digit value in cmH20
[SMON\r Set mute on
[SMOFF\r Set mute off
[[SCCxxx\r Compliance compensation mLiters/cmH2O Set to 0 if no compensation

2.8.5 Breathing Modes

[SCMV\r Continuous Mandatory Ventilation


[SSIMV\r Synchronized Intermittent Mandatory Ventilation
[SSPONT\r Spontaneous Ventilation (ASB mode)
[SPCV\r Precision Pressure Controlled Ventilation
[SSIMVPCV\r Synchronized intermittent mandatory ventilation pressure control ventilation
[SVMA\r Set Vent Mode Adult
[SVMP\r Set Vent Mode Pediatric

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The following strings are only sent when the ventilator is in Vent mode
and the user chooses a new ventilation mode, then confirms that
selection. This command is concatenation of other set strings, with an
additive and an xor checksum as follows:-

In this document the string is split up for clarity, in reality all strings are
sent together

[SBCF&mmmm , where mmmm=&SIMV, &SPONT, &PCV, &SIMVPCV or &CMV


&B%02.0f,set_bpm
&V%03.0f,set_tidal_volume*100
&R%02.0f,set_itoe*10
&L%02.0f,set_pressure_limit
&PE%02.0f,set_peep
&PT%02d,set_trigger_integer
&PS%02d,set_support_integer
&IT%03.0f,set_inspiratory_secs*100.0F
&IF%03d,0,inspiratory flow no longer used, so zero sent
&SON or &SOFFfor sigh on or off
&P%02d\r,pause_percentage or &POFF
&SF%03d, sigh_freq
&SV%02d, sigh_percent
Single byte (two char ) hex additive checksum of all previous bytes
Single byte (two char ) hex xor (exclusive or)checksum of all previous bytes

2.8.6 Breathing Control

[SSON\r Set sigh on


[SSOFF\r Set sigh off
[SPxx\r Pause on for % xx of inspired
[SPOFF\r Pause off
[SPTxx\r Set pressure trigger level xx = cmH2O
[SPSxx\r Set pressure support level xx = cmH2O

2.8.7 Measured Value Messages

[MBxx\r Measured breaths/minute. xx = 2 digit bpm value


[MTVxxx\r Measured Expired tidal volume. xxx = 3 digit value in centiliters
[MIVxxx\r Measured Inspired tidal volume. xxx = 3 digit value in centiliters

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Section 2 - 700/900 Series Ventilators

[MMVxxxr Measured minute volume. xxxx = 3 digit value in deciliters

[MPPxxx \r Measured breath pressure peak xxx=3 digit value in cmH2O*10

[MPMxxx\r Measured breath pressure min. xxx= 3 digit value in cmH20*10 (if
less than zero is DISABLED)
[MOxxxx\r Measured oxygen % concentration xxxx=4 digit value * 0.1%
[MIExx\r Measured I:E ratio xx= 2 digit value *0.1
[MFGxxx\r Measured fresh gas flow. The measured
fresh gas flow is from EFM unless the
EFM is not installed or has an error in
which case the internal flow sensor is used. xxx=deciliters/minute
[MFGVddd\r Measured fresh gas volume during
inspiratory, in mL, sent on a timed
basis while running.
[MMVIxxx\r Measured minute volume inspired. xxx = 3 digit value in deciliters
[MPLxxx\r Measured breath pressure plateau. xxx= 3 digit value in cmH20*10
[MPL---\r Measured breath pressure plateau invalid
[MFGOddd\r Oxygen fresh gas flow message ddd=decimal value of gas flow
in dL/min
[MFGO-\r Oxygen fresh gas flow invalid
[MFGNddd\r Nitrogen fresh gas flow message ddd=decimal value of gas flow i
n dL/min
[MFGN-\r Nitrogen fresh gas flow invalid
[MFGAddd\r Air fresh gas flow message ddd=decimal value of gas flow
in dL/min
[MFGA-\r Air fresh gas flow invalid
[MFGTOddd\r Oxygen gas consumption message ddd=decimal value of gas flow in dL
[MFGTO-\r Oxygen gas consumption invalid
[MFGTNddd\r Nitrogen gas consumption message ddd=decimal value of gas flow in dL
[MFGTN-\r Nitrogen gas consumption invalid
[MFGTAddd\r Air gas consumption message ddd=decimal value of gas flow in dL
[MFGTA-\r Air gas consumption invalid
[MGNinO_2ddd\r Inspired oxygen volume ddd=decimal value in volume * 10
[MGNinN_2Oddd\r Inspired nitrogen ddd=decimal value in mmhG * 10
[MGNinAGTddd\r Inspired agent ddd=decimal value in mmhG * 10
[MGNIMCO_2ddd\r Inspired minimum CO2 ddd=decimal value in mmhG * 10
[MGNetO_2ddd\r End tidal oxygen volume ddd=decimal value in volume * 10
[MGNetN_2Oddd\r End tidal nitrogen ddd=decimal value in mmhG * 10
[MGNetAGTddd\r End tidal agent ddd=decimal value in mmhG * 10

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Section 2 - 700/900 Series Ventilators

[MGNetCO_2ddd\r End tidal minimum CO2 ddd=decimal value in mmhG * 10


[MGNdO_2ddd\r Delta O2 Inspired volume ddd=decimal value of inspired-
expired O2 *10
[MFPSTddd\r Front Panel status ddd=front panel status bits
[MFPSTxxxxxxxx\r 3 2 BIT long (bits yet to be added)
Bit 0 1=Absorber Not Fitted
Bit 1 1=CGO Detected and switched

The cgo bit is set at the point of switching into cgo mode. In ventilation mode this
will be 10 seconds after the switch is first switched.

Bit 2 1=Front Panel Eeprom Failure


Bit 3 1=Fan Fail Enabled and Alarming

2.8.8 Event Message

[ESVCCC,FFF\r Ascii software version strings where CCC is the control system
software version number,FFF the front panel software version number.
[MXSNddddddd\r 7 digit serial number
[MXMSMAO\r Current mode is adult running
[MXMSMAS\r Current mode is adult standby
[MXMSMPO\r Current mode is pediatric running
[MXMSMPS\r Current mode is pediatric standby
[MXSMPWD\r Unit is entering 10 second power down phase
[EIOxxx\r Control inoperative xxx three digit code

2.8.9 User/System Settings

[USPP\r Sensor position at patient


[USPA\r Sensor position at absorber
[UAPxxx\r Set apnea time xxx=decimal seconds
[UABx\r Switching absorber x=1 if detected, 0 if not detected

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Section 2 - 700/900 Series Ventilators

2.8.10 User Alarm Limits

[UALBLxx\r BPM Low Limit (2-99)


[UALBHxx\r BPM High Limit (2-99)
[UALPLxx\r Pressure Low Limit (4-70) cms H2O
[UALPHxx\r Pressure High Limit (4-70) cms H2O
[UALVLxx\r Minute Volume Low Limit (1-25) Litres
[UALVHxx\r Minute Volume High Limit (1-25) Litres
[UALOLxxx\r Oxygen Concentration Low Limit(18-110) %
[UALOHxxx\r Oxygen Concentration High Limit(18-110) %

2.8.11 Waveform Information

[WFFFF,PPPP\r Waveform information. Where FFFF is a four digit flow value in deciliters per
minute and PPPP is a four digit pressure value in cms H2O *10

If negative, FFFF or PPPP will be preceded by a minus sign.


In the case of flow, negative means inspired period, i.e., flow is towards
the patient.

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Section 2 - 700/900 Series Ventilators
2.9 Alarm Messages
The alarm status will be sent every 4 secs unless an event had occurred which requires the alarm
status to be updated. The string sent will be as follows:
[MALMxxxxxxxx\r Front Panel Alarm status xxxxxxxx= 8 digit hex code as below.
BIT ALARM RANGE/SETTING DESCRIPTION
0 Apnea Pre-set. 30 seconds (default). User Defined 15-60secs.
1 Cycling Alarm Pre-set. Less than 5cmH2O (adult) or 3cmH2O in (pediatric) change pres-
sure per breath.
2 Pressure Low User defined. 4cmH2O to 50cmH2O.
3 Low Supply Gas Pressure Pre-set. 35 0.5psig.
4 Setting Error Pre-set. Ventilatory parameter set out of range.
5 Power Fail Pre-set. Mains electrical supply failure.
6 Battery Low Pre-set. <15 minutes battery life remaining.
7 No Charge Pre-set. Mains supply ON, battery not charging.
8 Comms Fail Pre-set. Internal communications error.
9 Pressure High User defined. 0cmH2O to 70cmH2O.
10 MV High User defined. 1 l/m to 25 l/m.
11 MV Low User defined. 1 l/m to 25 l/m.
12 High BPM User defined. 2BPM to 99BPM.
13 Low BPM User defined. 2BPM to 98BPM.
14 High Oxygen User defined. 18% to 100%.
15 Low Oxygen User defined. 18% to 100%.
16 PEEP Error Pre-set.
17 Under Pressure Pre-set.
18 Vent Inoperative Pre-set. System Failed.
19 Press Limit High User defined.
20 Fresh Gas Flow Too High Pre-set.
21 Sensor Error Pre-set.
22 Oxygen Sensor Error When oxygen reading is on-screen, but oxygen sensor is not fitted.
23 Absorber Not Fitted Absorber not fitted when that feature is selected on the vent.
24 Alt CGO Alarm Alarm occurs whilst switching to CGO, only whilst ventilating. The alarm is
active for 10 seconds before the switch into ACGO mode prompts the user to
possibly switch back.
25 Sub Atmospheric Alarm Pressure has been below -10cmsH2O for 1 second.
26 Fan Fail If enabled in the system, is active when the hardware detects a fan failure.

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Section 2 - 700/900 Series Ventilators

BIT ALARM RANGE/SETTING DESCRIPTION


27 Oxygen Supply Fail Supply to the oxygen sensor has failed.
28 Cal Error Eeprom failure, or lack of calibration has meant that the calibration data is not
correctly set.
29 Check Total Flow Displayed during a case if:

any flow from the EFM indicates an error.

flow data has not been received from the Front Panel for greater than
90 seconds
the FgO2 indicated from the EFM is less than 100 ml/min.
30-31 Not Used Note: The relevant bits are set if an alarm has occurred. Unused bits should never
be set.

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Section 2 - 700/900 Series Ventilators

2.10 Error Codes


Error Error Name Description Error Error Name Description
Code Code

1 E_PIO_PORTA N/A 29 E_ADC_ Drive


DPRESZERO_LOW pressure
2 E_PIO_PORTB N/A zero is too
low
3 E_ADC_VOLSET_UNDER 6X00 only
30 E_ADC_ Drive
4 E_ADC_VOLSET_OVER 6X00 only
DPRESZERO_HIGH pressure is
5 E_ADC_BPMSET_UNDER 6X00 only too high

6 E_ADC_BPMSET_OVER 6X00 only 31 E_ADC_5VANEG The -5V


supply
7 E_ADC_IERATIOSET_UNDER 6X00 only is out of
8 E_ADC_IERATIOSET_OVER 6X00 only specification

9 E_ADC_PRESLIMSET_UNDER 6X00 only 32 E_ADC_5VA The 5V


Analog
10 E_ADC_PRESLIMSET_OVER 6X00 only supply
is out of
11 E_ADC_PRESLOLIM_UNDER 6X00 only specification
12 E_ADC_PRESLOLIM_OVER 6X00 only 33 E_ADC_5VMAG 6x00 only
13 E_ADC_PRESHILIM_UNDER 6X00 only 34 E_ADC_5VALARM The 5V
14 E_ADC_PRESHILIM_OVER 6X00 only Alarm
supply
15 E_ADC_COMPOT_UNDER N/A is out of
specification
16 E_ADC_COMPOT_OVER N/A
35 E_ADC_5VD The 5V
17 E_ADC_DEVLINK_3_5 N/A
Digital
18 E_ADC_DEVLINK_6_8 N/A supply
is out of
19 E_ADC_DEVLINK_9_11 N/A specification
20 E_ADC_FLOWZERO_LOW Flow zero is too low 36 E_ADC_6V The 6V
supply
21 E_ADC_FLOWZERO_HIGH Flow zero is too high
is out of
22 E_ADC_INTREF N/A specification

23 E_ADC_TEST0 Internal i/o test line 37 E_TEST_LINK The 8 way


0 failed test link
headrer is
24 E_ADC_TEST1 Internal i/o test line incorrect
1 failed
99 E_MEM_UNPROTECT N/A
25 E_ADC_TEST2 Internal i/o test line
2 failed 100 E_COM0_IBUF_FULL N/A

26 E_ADC_TEST3 Internal i/o test line 101 E_COM0_DEV_ERR N/A


3 failed
102 E_COM1_IBUF_FULL N/A
27 E_ADC_PPRESZERO_LOW Patient pressure
103 E_COM1_DEV_ERR N/A
zero is too low
104 E_PARAM_CHKSUM
28 E_ADC_PPRESZERO_HIGH Patient pressure
zero is too high 105 E_PROG_CHKSUM N/A
106 E_RAM_READ_WRITE N/A

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Section 2 - 700/900 Series Ventilators

Notes:

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Section 3
CAS I/II Absorber

BleaseSirius User Manual 183


Section 3 - CAS I & CAS II Absorbers

Read this Section before operating the Absorber.

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Section 3 - CAS I & CAS II Absorbers

M N O
L A
L
K
J

I B
C
H
G D
F
E

Figure 112 Key


A APL Valve
B Bypass Switch (optional), not available in the USA
C Expiratory Non-return Valve
D Canister
E Bag Arm Link Pipe (Bag Port)
F Patient Expiratory Connector (22mm male and
15mm female taper)
G Oxygen Sensor Port & Oxygen Sensor Port
Blanking Plug
H Patient Inspiratory Connector (22mm male and
15mm female taper)
I Bag Arm & Port (optional)
J Inspiratory Non-return Valve
K Bag/Vent Switch
L Manometer Gauge
M Fresh Gas Port
N APL Exhaust Port
O Vent Port
Figure 112 - CAS I and CAS II Absorber Components

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Section 3 - CAS I & CAS II Absorbers

3.1 Description
3.1.1 Introduction
Please refer to Figure 112 on the previous page as you read this section.

Two models of the CAS Absorber are available - CAS I and CAS II. The CAS
I model houses one soda lime canister, while the CAS II model houses two
canisters.

All of the plastic moldings are made from fully autoclavable polymers.

An Airway Pressure Limiting [APL] valve (A) sets the ventilating pressure
during manual operation mode. The APL valve incorporates a 65 cmH2O
safety valve.

The optional Bypass Valve (B) allows gas flow to completely bypass the ab-
sorbent. This valve can be used to allow a build-up of CO2 or enable canister
removal/replacement without disconnecting the breathing circuit.

The Bag/Vent switch (K) allows the ventilator or bag to be connected to the
absorber at the same time. Use the selector switch to choose the desired
mode of ventilation.

Optional accessories available for the absorber include the detachable


manometer (-10 cmH2O to 100 cmH2O).

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Section 3 - CAS I & CAS II Absorbers

3.1.2 Principles of Operation


Please refer to Figure 113 on the next page as you read this section.

3.1.2.1 Spontaneous Breathing


When used with spontaneously breathing patients, the required gas flow is set
and continuously tops off the bag. When the patient breathes in, gas is drawn
through the inspiratory non-return valve (B) from the bag via the canisters (F)
containing soda lime.

Upon exhalation, the gas flows through the expiratory non-return valve (E),
some gas is blown through the APL valve (G), which should be set to balance
the fresh gas flow, while the bulk is returned to the bag via the bag port (N).

3.1.2.2 CO2 Bypass (not available in US)


The CO2 Bypass valve (I) allows gas to be delivered to the patient without
passing through the canister(s), so that CO2 levels can be increased or the
canister(s) can be replaced while the absorber remains in use.

3.1.2.3 Scavenging
The APL valve (G) has a 30 mm taper port for removing exhaust gases.

3.1.2.4 Absorbent
Gas flows down the center through the soda lime canister(s) and then up be-
tween the outer and inner canisters.

Under some conditions, this gas flow will cause condensation on the
inside of the outer canister. This condensation is normal and does not
interfere with its normal function.

Normally, soda lime contains an indicator that changes color when the soda
lime is exhausted. When the color change reaches the top of the lower
canister on a CAS II Absorber, you should replace its contents and switch the
positions of the two canisters. Also, if the CO2 monitor registers a rise in the
inspired CO2 level, you should check the absorbent to determine if it needs to
be replaced. For a CAS I Absorber, the contents of the single canister should
simply be replaced. Alternatively, you may use disposable canisters.

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Section 3 - CAS I & CAS II Absorbers

Figure 113 - Absorber Flow Circuit

Figure 113 Key


A Manometer
B Inspiratory Non-return Valve
C Patient Inspiratory Connector
D Patient Expiratory Connecto
E Expiratory Non-return Valve
F Canister(s)
G APL Valve
H Oxygen Sensor Port
I Absorber CO2 Bypass Valve (not
available in USA)
J APL Exhaust Port
K Fresh Gas Port
L Bag/Vent Valve
M Ventilatory Port
N Bag Port

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Section 3 - CAS I & CAS II Absorbers

3.2 Installation
The absorber is supported on two shafts which are integral to the machine. A
ventilator bellows is mounted behind the absorber and all connections be-
tween the two are made when the absorber is docked into position.

Use the absorber only in the upright position. Use in any other
orientation may affect the gas flow or damage the absorber.

3.2.1 Install the Absorber on the Machine


1. Align the mounting holes on the side of the bellows base onto the support
shafts on the left side of the machine.

2. Attach the ventilator bellows to the machine bracket arm with the
fasteners provided.

3. Align the holes on the rear of the absorber main


plate with the horizontal shafts on the end of the
bracket arm (Figure 114). Slide the absorber into
place until the security catch engages on the
mounting shaft.

3.2.2 Fill the Soda Lime Canister(s)


The outer canister of the CAS I Absorber holds a
single reusable canister. The outer canister of the Figure 114 - Install the
CAS II Absorber holds two reusable canisters. The Absorber
reusable soda lime canister(s) is installed in the outer
canister when the absorber is shipped. Before using the absorber, you need to
fill the inner canister(s) with soda lime. If you prefer, you can use a disposable
soda lime canister(s) with the CAS I/II Absorber.

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Section 3 - CAS I & CAS II Absorbers

Soda Lime is caustic. Observe the manufacturers instructions for


correct handling and storage. When handling soda lime, always wear
suitable eye, face and hand protection since crushed soda lime can
degrade to a fine dust which may be harmful by inhalation. To minimize
the levels of soda lime dust, ensure that the soda lime is not crushed
and that you clean the absorbers and breathing circuits regularly. To
prevent injury to the patient, always protect the patients face using a
face mask.
Always fill the reusable canisters to the recommended level. Under-
filling the soda lime canister(s) can lead to inefficient CO2 absorption,
while overfilling can result in poor canister sealing.

The condensate in the bottom of the outer canister is caustic. Drain it


periodically. Accidental splashes should be rinsed immediately with
water.

After an absorber canister has been filled/refilled with soda lime, verify
that the upper seal has been properly replaced. This seal is located
above the upper soda lime canister attached to the molding within
the body of the absorber. Always ensure that all seals are correctly
replaced when re-assembling the absorber to prevent leaks.

Perform all leak tests after installing or refilling the canister(s).

If you will use disposable canister(s), the following types have been
tested with CAS I/II Absorbers. These disposable canisters seal
correctly and are approved for use with Spacelabs Healthcare
Anesthesia equipment. Note that checking for a correct seal with any
manufacturers disposable canisters is the responsibility of the user.
Contact Spacelabs Healthcare Technical Support for more information.

The approved disposable canisters are:

Intersurgical The Drum


GE MediSorb Pre-packed
cartridge disposable.
Allied Healthcare Carbolime.
Armstrong MedicalAmsorb Figure 115 - Amsorb Seal
(Figure 115) [always remove the
seal installed on the top of the Amsorb canister].

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Section 3 - CAS I & CAS II Absorbers

3.2.2.1 For Disposable Soda Lime Canister(s)


1. Remove the outer canister from the absorber. Using both hands, grasp
the outer canister and turn it clockwise until it is released.

2. Set the canister on a clean work surface.

3. Remove the inner canister(s). If you have two inner canisters, remove the
center seal.
4. Remove any protective wrapping from the disposable canister(s).
Keep the canister upright at all times to prevent spills. Be sure to wear
protective gear when handling soda lime.
5. Insert one disposable soda lime canister in the outer canister.

6. If you have the CAS II Absorber, place the center seal


on top of the inner canister. Orient the seal so the tabs
are on the bottom (Figure 116). The double arrow icon
on the side of the seal (Figure 117) should point up.
Place the second disposable canister on top of the
seal. Figure 116 - Canister
Seal Orientation Icon
7. Reattach the outer canister to the absorber. Lock it
in place by turning it fully counterclockwise.

8. Store the reusable canisters in a safe place for possible


future use.
Figure 117 - Center Seal Icon

3.2.2.2 For Reusable Soda Lime Canister(s)


The CAS I/II reusable canister has a capacity of approximately 1 kg/2.2lbs of
soda lime.
1. Wear protective eye, face and hand protection for this procedure. You will
be handling caustic substances.

2. Remove the outer canister from the absorber. Using both hands, grasp
the outer canister and turn it clockwise until it is released.

3. Set the canister on a clean work surface.

4. Remove the inner canister(s). If you have two inner canisters, remove
the center seal.

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Section 3 - CAS I & CAS II Absorbers

5. Fill the inner canister(s) with fresh soda lime just below the top of the
canister.

When filling a canister, pour the soda lime carefully and steadily. Gently
tap the sides to settle the granules and carry on filling until the canister is
almost full. Do not tap the canister violently as this action creates dust.

6. Insert one filled soda lime canister in the outer canister.

7. If you have the CAS II Absorber, place the center seal on top of the inner
canister. Orient the seal so the tabs are on the bottom (Figure 116). The
double arrow icon on the side of the seal (Figure 117) should point up.
Place the second disposable canister on top of the seal.

8. Check that the upper seal on the absorber is in place and seated
securely (Figure 118).

9. Reattach the outer canister to the


absorber. Lock it in place by turning it fully
counterclockwise.

10. Verify that the canister is properly seated on


the absorber.

3.2.3 Bag Arm Link Pipe


If you have the bag arm option and the pipe Figure 118 - Absorber Upper Seal
has been removed, connect the bag arm
link pipe to the absorber as shown in Figure
119. Ensure that the pipe is in place before use.

Under some conditions during use, condensa-


tion may collect in the bag arm link pipe. It is
recommended that you periodically drain the
pipe by removing one end and draining any
liquid. You may need to use a suction catheter
to remove liquid from this area. (Dispose of the
catheter tip after use).

Figure 119 - Bag Arm Link Pipe

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Section 3 - CAS I & CAS II Absorbers

3.2.4 Attach the Breathing Circuit Tubing


Attach the patient breathing circuit tubing (A) and the bag tubing (D) as shown
in Figure 120 below.

Figure 120 - Connect the Breathing Circuit Tubing

Figure 120 Key


A Patient End, Breathing
Circuit Tubing
B Inspiratory Connector
C Expiratory Connector
D Bag Tubing
E Vent Port
F APL Exhaust Port
G Fresh Gas Port

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Section 3 - CAS I & CAS II Absorbers

3.2.5 Pre-Use Checks

Injury to the patient may result if you use a faulty absorber. If the
absorber malfunctions, or if the absorber does not pass all pre-use
tests, do not use the absorber. Injury to the patient may result. Contact
an authorized technical engineer or return the unit to your local
distributor.

Before you use the absorber, always perform the following inspections and
tests.
1. Carefully inspect the absorber for damage.
2. Verify that the absorbent canisters are installed. Verify that all canister
seals are present and are correctly installed.

3. Remove the two non-return valve covers and check that both the
inspiratory and expiratory valve discs are clean and free to operate.
Check the valve seats for chips, damage, etc. Replace the discs and
covers, if necessary.
4. If installed, check that the bypass switch is in the ABSORBER ON
position.
5. Verify that the oxygen sensor port either has an oxygen sensor installed
or that the oxygen sensor port blanking plug is installed.

6. Ensure that all absorber tubing is correctly and securely installed.


7. Perform the steps given in the System Check section in the ventilator user
manual.

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Section 3 - CAS I & CAS II Absorbers

3.2.5.1 Compliance Test

To perform this test, follow the steps given in Section 2.3.4.2 in the
Ventilator section of this manual.

3.2.5.2 Spontaneous Breathing Setup

If the APL valve is not in the OPEN position, it will not operate until
the pressure reaches approximately 65 cm H2O. To allow Spontaneous
breathing, set the APL valve to OPEN.

1. Open the APL valve as required.

2. Fit a bag to the bag port.

3. Set the Bag/Vent switch to Bag.

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Section 3 - CAS I & CAS II Absorbers
3.3 Absorber Maintenance
Hand tools are not required to perform routine maintenance of the CAS
I/II Absorbers.

3.3.1 Change the Canister Soda Lime


3.3.1.1 Replace the Reusable Canister Soda Lime

Soda Lime is caustic. Observe the manufacturers


instructions for correct handling and storage. When handling soda lime,
always wear suitable eye, face and hand protection as crushed soda
lime can degrade to a fine dust which may be harmful by inhalation.
To minimize the levels of soda lime dust, ensure that the soda lime is
not crushed and that you clean the absorbers and breathing circuits
regularly. To prevent injury to the patient, always protect the patients
face using a face mask.

Under-filling the soda lime canister(s) can lead to inefficient CO2


absorption, while overfilling can result in poor canister sealing. Always
fill the reusable canisters only to recommended level.

The condensate in the bottom of the outer canister is caustic. Drain it


periodically. Accidental splashes should be rinsed immediately with
water.
After an absorber canister has been filled/refilled with soda lime, there
have been instances where the upper seal has not been replaced
which results in a leak. This seal is located above the upper soda
lime canister attached to the molding within the body of the absorber.
Please ensure all seals are correctly replaced when re-assembling the
absorber.

Always perform the Leak Test after changing the soda lime.

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3.3.1.2 Absorbent Capacity of Canister Soda Lime


The absorbent capacity of a canister of soda lime depends on the soda lime
performance, but also on other factors, including:
the gas flow rate
the size of the patient and their respiratory and metabolic rate
the design and packing of the absorber and breathing circuit
the handling and condition of the soda lime.
For example, it is estimated that the soda lime will absorb approximately 140
liters of carbon dioxide per kg/lbs, which equals 24 hours per kg/lbs for an av-
erage patient producing 200 cm3 of carbon dioxide per minute, using a fresh
gas flow rate of 1.0 l per minute (assuming 50% rebreathing).

Desiccated (dehydrated) absorbent material may produce dangerous


chemical reactions when exposed to inhalation anesthetics. Take
adequate precautions to ensure that the absorbent material does not
dry out. Always turn off all gasses when finished using the system.

3.3.1.3 When to Replace the Soda Lime


For the CAS I Absorber: Replace the soda lime when the color change reach-
es the top of the canister or when inspired CO2 is noted on the CO2 monitor.

For the CAS II Absorber: Replace the soda lime when the color change
reaches the top of the lower canister or when inspired CO2 is noted on the CO2
monitor. Replace its contents and switch the positions of the two canisters.

To replace the soda lime:


1. Wear protective eye, face and hand protection for this procedure. You will
be handling caustic substances.

2. Remove the outer canister from the absorber. Using both hands, grasp
the outer canister and turn it clockwise until it is released.

3. Keeping the canister upright at all times, set the canister on an


appropriate work surface.

4. Carefully remove the inner canister(s).

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Section 3 - CAS I & CAS II Absorbers

5. Discard any condensate in the outer canister according to the policies of


your facility.

6. Carefully empty the inner canister(s) by pouring the used soda lime out of
the hole at the top of the canister. Discard the soda lime according to the
policies of your facility.

7. Check that the bottom of the inner canister(s) and the central seal (for the
CAS II Absorber) are free from soda lime dust. Clean, if necessary.

8. Check that the large upper seal around the


molding (Figure 121), on the underside of the
absorber, is free from soda lime dust. Remove
the seal to clean, if necessary. Check that the
seal is firmly in place. The absorber cannot
function correctly without it.

9. Carefully fill the inner canister(s) with soda lime


to just below the top of the canister.
Figure 121 - Large Upper
10. Carefully insert the soda lime canister into the
Seal
outer canister.

11. If you have the CAS II Absorber, place the center


seal on top of the inner canister. Position the seal so
the tabs are on the bottom (Figure 122). The double
arrow icon on the side of the seal (Figure 123) should
point up. Place the second soda lime canister on top
of the seal.
Figure 122 - Canister Seal
12. Reattach the outer canister to the Orientation Icon
absorber. Lock it in place by turning it fully
counterclockwise.

13. Verify that the canister is properly seated on the absorber.

Figure 123- Center Seal


Icon

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3.3.1.4 Change a Disposable Canister


Always use a disposable soda lime canister that has been approved for use
on a Spacelabs Anesthesia machine. See Section 3.2 for a list of approved
disposable canisters.

1. Wear protective eye, face and hand protection for this procedure. You will
be handling caustic substances.

2. Remove the outer canister from the absorber. Using both hands, grasp
the outer canister and turn it clockwise until it is released.

3. Set the canister on a clean work surface.

4. Remove the inner canister(s). If you have two inner canisters, remove the
center seal.

5. Remove any protective wrapping from the disposable canister(s). Keep


the canister upright at all times to prevent spills.

6. Insert one filled disposable soda lime canister in the outer canister.

7. If you have the CAS II Absorber, place the center seal on top of the
inner canister. Orient the seal so the tabs are on the bottom. The double
arrow icon on the side of the seal (Figure 123) should point up. Place the
second disposable canister on top of the seal.

8. Check that the large upper seal around the molding (Figure 121), on the
underside of the absorber, is free from soda lime dust. Remove the seal
to clean, if necessary. Check that the seal is firmly in place. The absorber
cannot function correctly without it.

9. Reattach the outer canister to the absorber. Lock it in place by turning it


fully counterclockwise.

10. Verify that the canister is properly seated on the absorber.

11. Perform the Leak Test.

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Section 3 - CAS I & CAS II Absorbers

3.3.1.5 Storage of Soda Lime


Soda lime is supplied in plastic or foil laminated air tight containers. It must
remain sealed and stored in a clean dry environment, at an even temperature
between 0C/32F and 35C/95F. Efficiency and service life are reduced
when stored at higher temperatures.

Considerations for Soda Lime Storage


Do not:
store in direct sunlight.
store in contact with or close to incompatible chemicals or acids.
partially or totally immerse in water.
store in atmospheres with abnormal concentrations of carbon dioxide,
hydrogen sulphide or other acidic gases.

3.3.2 Cleaning and Sterilization


Clean the absorber as required.

The condensate in the bottom of the outer canister is caustic. Drain it


periodically. Rinse accidental splashes immediately with water.

Do not use caustic substances such as trichlorethylene for cleaning the


absorber as it may damage the surfaces.

Do not autoclave the manometer.

Other than stated, the components and materials of the absorber are
compatible with autoclaving and Ethylene Oxide sterilization processes.

1. Wear appropriate eye, hand and face protection when cleaning the
absorber. You will be handling caustic substances.

2. Remove the outer canister from the absorber. Using both hands, grasp
the outer canister and turn it clockwise until it is released.

3. Remove the inner canister(s) and dispose of the contents (reusable


canister) or the disposable canister(s). Dispose of any condensate from
the bottom of the outer canister.

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Section 3 - CAS I & CAS II Absorbers

4. Remove the large upper seal around the absorber molding (Figure 10) on
the underside of the absorber.

5. Remove the Manometer, if installed. See the Manometer section in


Section 3.5 for instructions.

6. Remove the non-return valves by turning counter-clockwise to disengage


the bayonet fitting and then lifting out. Remove the valve discs.

7. Remove the APL valve. Lift up the spring-loaded APL cover stop, then
turn the cover counterclockwise to disengage the bayonet fitting and lift
out. Remove the valve disc.

8. If installed, set the Bypass valve to Absorber On.

9. If bag arm option is installed, remove bag and bag arm link pipe.

10. If connected, remove O2 Probe. It cannot be cleaned or sterilized.

11. Wash all components in hot water. Check each component and the
seals for any small particles of soda lime, which can destroy the
integrity of valves and seals. Remove any accumulated soda lime.

12. Pack all components that can be sterilized separately in the autoclave for
sterilization at 134C max.

Autoclave the canisters and separate plastic parts in an upright position


and away from other components.

13. After sterilization, re-install the components in the order removed.

O2 Probe (if connected).


Bag Arm option (if installed).
APL Valve. Keeping the APL valve upright, lift up the spring-loaded APL
cover stop, then align the scallop-shaped cutout on the APL valve with
the cover stop. Turn the APL valve clockwise past two notches to secure
it properly to the absorber (Figure 124 on the next page). Release the
cover stop.

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Section 3 - CAS I & CAS II Absorbers

Figure 124 - Reinstall the APL Valve Past


Two Notches

Non-Return Valves. Replace the valve discs. Insert a valve on the


absorber then turn it clockwise to engage the bayonet fitting. Repeat
with the other valve.
Manometer (if installed). See the Manometer section 3.5.
14. Check that the large seal around the black interface molding, on the
underside of the absorber, is free from soda lime dust. Reinstall the seal
on the absorber, gently pushing it in place, then verify that the seal is
firmly in place.

15. Refill the soda lime canister(s) as instructed earlier in this chapter and
insert it in the outer canister. Reattach the outer canister to the absorber.
Lock it in place by turning it fully counterclockwise.

16. Perform the pre-use checks. See Section 3.2.5 for instructions.

3.3.3 Routine Maintenance Checks


3.3.3.1 Replace the Non-return Valve Discs
1. Remove a non-return valve disc by turning the cover counter-clockwise
to disengage the bayonet fitting and then lifting out.

2. Remove the valve disc and replace with a new one.

3. Replace the cover by turning it clockwise.

4. Repeat steps 1-3 to replace the other non-return valve disc, if needed.

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Section 3 - CAS I & CAS II Absorbers

3.3.3.2 Annual Maintenance


Hand tools are not required to perform routine maintenance of the CAS
I/II Absorbers. Never use tools in the active area of an MRI scanner.

The absorber service kit contains the items listed in the table below. Be sure to
order the correct kit for the CAS absorber installed on your machine.

CAS I Service Kit, PN 12200218


CAS II Service Kit, PN 12200219
To obtain a service kit, contact Spacelabs Healthcare Technical Support or
your local Spacelabs representative.

Part Description Quantity Part Number


Large Seal for Outer Canister 1 SI0821
Fresh Gas Hose 1 12200421
Manometer O-ring 1 51150045
O2 Port Blanking Plug O-ring 1 12200547
NRV Cover O-ring 3 12200548
Upper Seal 1 12200557
Central Seal (CAS II Only) 1 12200556

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Section 3 - CAS I & CAS II Absorbers

3.4 Spare Parts and Accessories


This section describes optional accessories available for use with the CAS I
and CAS II Absorbers. For further details, contact Spacelabs Healthcare Tech-
nical Support or your local Spacelabs representative.

Part Description Part Number


CAS I Absorber with CO2 Bypass (not available in US) 12200901
CAS I Absorber without CO2 Bypass (not available in US) 12200903
CAS II Absorber with CO2 Bypass 12200900
CAS II Absorber without CO2 Bypass 12200902
Manometer -10cmH2O to 100cmH2O 54300047
Mounting Bracket Assembly for BleaseSirius Trolley 12200518/517
Absorber detachables:
Patient Circuit Assembly M1050-4
2-Liter Bag ST2111
Corrugated Hose 42 ST2101
Fresh Gas Hose with 22mm/0.8 connector 630105
Re-usable Soda Lime Canister 12200221
O Ring SI0820
Soda Lime Canister Central Seal (for use on CA 2kg) 12200556
Upper Seal 12200557
Soda Lime Twinpack Cartons:
9kg/19.8lbs carton ST7782
20kg/44.0lbs drum ST7783
50kg/110.2lbs drum ST7784
Non-return Valve Cover 12200025
Non-return Valve Disc 12200162
22mm/0.8 Adaptor with Recess ST4718

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Section 3 - CAS I & CAS II Absorbers

3.5 Manometer

Non-MRI Manometer -10 cmH2O to 100 cmH2O, White


Part Number: 54300047

The manometer provides pressure measurement in


the range -10 cmH2O to 100 cmH2O. The manom-
eter uses a quick-release connector that allows easy
removal before sterilization of the absorber. The con-
nector also allows rotation of the manometer through
360 about the connector to any convenient viewing
position. Figure 125 - Non-MRI
Manometer
3.5.1 Install the Manometer
1. Insert the manometer stem into the labelled connector.

2. Gently push the manometer until it snaps in place.

3.5.2 Remove the Manometer


1. Hold the manometer with one hand. With the other hand, push the tab on
the front of the connector towards the back of the absorber.

2. Lift the manometer out of the connector.

Always remove the manometer before you sterilize the absorber.

3.6 Oxygen Sensor


The oxygen sensor port is located in the front of the absorber (See Figure
112-G). If you do not use a sensor, insert a blanking plug in the port.

When not in use, the blanking plug should be parked in the recess located in
the underside of the absorbers lower, (interface) molding, at the front right
hand corner.

The oxygen sensor measures the concentration of oxygen on the patient


circuit.

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Section 3 - CAS I & CAS II Absorbers

3.7 Absorber Technical Data

3.7.1 Dimensions
Dimension 2kg/4.4lbs 1kg/2.2lbs
Height (excluding manometer) 340mm/13.3 244mm/9.6
Width 184mm/7.2 184mm/7.2
Depth 320mm/12.5 320mm/12.5
Weight
Full 7.1kg/15.6lbs 6.0kg/13.2lbs

Empty 5.1kg/11.2lbs 5.0kg/11.0lbs

3.7.2 Performance

Parameter Performance Reference


Leakage Absorbing 15ml/min As per GG.11

Bypass >5ml/min
Expiratory Resistance Absorbing 1.8cmH2O As per GG.6

Bypass 2.1cmH2O
Inspiratory Resistance Absorbing -3.9cmH2O As per GG.7

Bypass -2.2cmH2O

3.7.2.1 Performance as defined in EN 740:1999 E.

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Section 4
Notices &
Important
Information

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Section 4 - Notices & Important Information

Notes

208 BleaseSirius User Manual


Section 4 - Notices & Important Information

4.1 Product Improvement


Spacelabs Healthcare has a policy of continued product improvement and
therefore reserves the right to make changes which may affect the information
contained in the manual without giving prior notice.

4.2 Responsibilities of the User


The BleaseSirius conforms with the specifications and operating procedures
described in this manual and on any accompanying notices and labels only
if it has been installed, used and maintained in accordance with the instruc-
tions. The safe function of the ventilator can only be guaranteed if it is regu-
larly checked and serviced at or in excess of the standards specified in this
manual.
If the ventilator is suspected of being worn, defective or otherwise unfit for use,
it should under no circumstances be used.
Broken, worn, missing or contaminated component must be replaced im-
mediately; contact Spacelabs Healthcare Technical Support or your local
Spacelabs representative.

4.3 Responsibilities of the Manufacturer


The manufacturer accepts responsibility for the effects on safety, reliability and
performance of the equipment only if:

assembly operations, extensions, adjustments, modifications and


repairs are carried out by persons with written authorization from the
manufacturer.
the equipment is used in accordance with the instructions for use.
the electrical installation of the relevant room complies with the
Regulations for the Electrical Equipment of Buildings.

If during the warranty period the equipment is serviced by an


unauthorized party, the warranty will be void.

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Section 4 - Notices & Important Information

4.4 Disclaimer
Opening of the control unit by unauthorized personnel automatically voids all
warranties and specifications. The prevention of tampering is solely the users
responsibility; the manufacturer assumes no liability for any malfunction or
failure of the ventilator if the control unit is opened.

4.5 Technology Disclaimer / Tamper Proof Seal


Unauthorized removal of or damage to seal will invalidate product warranty
and could affect accuracy and performance of this product.

In the interest of both patient and user safety no unauthorized calibration or


access to technical techniques and practices including calibration information
of this product will be issued.

The technical performance and characteristics of this product belong to


Spacelabs Healthcare. Under no circumstances will those details be issued to
non-Spacelabs Healthcare personnel.

Technical data, calibration co-efficients and all intellectual property rights of


this product remain the property of Spacelabs Healthcare. To ensure correct
functioning, the equipment must be serviced at regular intervals.

4.6 Note to Service Personnel


The BleaseSirius and integrated equipment must only be serviced by Qualified
Technical Engineers.

The contents of this manual are not binding. If any significant difference
is found between the product and this manual, please notify Spacelabs
Healthcare.

To ensure correct functioning, the equipment must be serviced at regular


intervals.

Spacelabs Healthcare recommends that the machine should be serviced


annually. Qualified Technical Engineers and genuine spare parts should be
used for all servicing and repairs. Spacelabs Healthcare will not otherwise
assume responsibility for the materials used, the work performed or any
possible consequences of the same.

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Section 4 - Notices & Important Information

For all communication with Spacelabs Healthcare, quote the model and
serial number of the equipment, with the approximate date of purchase. If the
equipment is being returned for repair, indicate the nature of the fault or the
work you require to be carried out.

Contact your local dealer:

Spacelabs Healthcare Inc. (Company Headquarters)


5150 220th Ave. SE
Issaquah, WA 98029 USA

Tel: +1 425-657-7200 North America: +1 800-522-7025


Fax: +1 425-657-7212

Spacelabs Healthcare Ltd.


(Anesthesia Delivery and Ventilation Division)
1 Harforde Court
John Tate Road, Hertford
SG13 7NW United Kingdom

Tel: +44 (0)1992 507700


Fax: +44 (0)1992 501213

e-mail (enquiries): advsales@spacelabs.com


e-mail (technical): advsupport@spacelabs.com
www.spacelabshealthcare.com

4.7 Copyright
2010, Spacelabs Healthcare Limited,
Anesthesia Delivery and Ventilation Division
All rights reserved. The information contained in this publication may not be
used for any other purpose than that for which it was originally intended.
This publication may not be reproduced in part or in whole without the written
consent of Spacelabs Healthcare.

4.8 CE Marking

The product is labeled with the CE mark and notified body number.

BleaseSirius User Manual 211


Section 4 - Notices & Important Information

4.9 Trademarks and Acknowledgements


The following trademarks and acknowledgements may appear in Spacelabs
Healthcare Manuals.

is the trademark of Abbott Laboratories.

Da-LitesTM is a trademark of Spacelabs Healthcare Ltd.


Datum is a trademark of Spacelabs Healthcare Ltd.
Dowty is a trademark of Dowty Seals Limited.
Draeger is a trademark of Draegerwerk AG Germany.
Dzus is a trademark of Dzus Fasteners Limited.
Fomblin is a registered trademark of Rocol Limited.
BleaseSirius is a trademark of Spacelabs Healthcare Ltd.
Legrand is registered trademark of Legrand Electric Limited.
Loctite is a registered trademark of Loctite Corporation USA.
Megger is a trademark of AVO Megger Instruments Ltd.
Plug-in is a registered trademark of Draegerwerk DAG Germany.
Quik-Fil is a trademark of Abbott Laboratories.
Rigel is a trademark of Seaward Electronics Ltd.
Scotchbrite is a registered trademark of 3M.
SELECTATEC is a registered trademark of Ohmeda/BOC UK Ltd.
Snoop is a registered trademark of the Nupro Company Ohio USA.
Trak Wheel is a trademark of Spacelabs Healthcare Ltd.

212 BleaseSirius User Manual


Section 4 - Notices & Important Information

4.10 Hazard Notices


This handbook contains important hazard information. You must read this
hazard information before using the BleaseSirius Anesthetic Machine.

Warning Notices

Warning notices denote a potential hazard to the health and safety of


users and/or patients. These notices clearly state the nature of the
respective hazard and the means by which it can be avoided.

Warning notices appear in full in the preliminary pages and are


repeated at their points of application in the manual.

Caution Notices

Cautionary notices denote a potential hazard to the physical integrity


of equipment/software but NOT a danger to personnel. These notices
clearly state the nature of the hazard and the means by which it can
be avoided.

Note
The Note symbol identifies relevant or helpful information

BleaseSirius User Manual 213


Section 4 - Notices & Important Information

*Statements are made to comply with the requirements of IEC 60601-1


and IEC 60601-2-13. IEC 60601-1 classification;
Class I equipment
Type B applied part
Not for use with flammable anesthetic
Continuous operation.

BleaseSirius Warnings

USE OF EQUIPMENT
Incorrect use of the equipment described herein may result in injury to the
patient. Read this manual before operating the machine. You must be familiar
with the machine and its functions before using it on a patient.
Be sure to pay special attention to warnings, cautions and notes within the
manual. A full list of these can be found in Section 4 of this manual.

*LATEX FREE NOTICE*


The BleaseSirius is latex free, note that any replacement parts must not use
latex.

ELECTROSTATIC SENSITIVE DEVICES


All ESD must be stored in approved conductive packaging, `tubes, shipping
bags, foam or tote bins.
All persons handling ESD must be properly grounded via a 1mW resistive
grounded wrist strap.
Cover all ESD bench tops with grounded conductive mats and connect all
work surfaces and equipment to earth ground.
Transport all assemblies containing ESD in a conductive bag or container.
Do not use cellophane adhesive tape to wrap DIP (dual in-line package) tubes
together. DO NOT handle ESD by their pins or mix them with other routine
electronic parts.
Never place ESD on ungrounded surfaces or leave them unattended in an
open area.
Avoid cellophane wrappers, synthetic (non-conductive) carpeting, warm or
cool air blasts, styrofoam coffee cups, etc when working with ESD.
Use only properly designed heat lamps, heat chambers and/or antistatic
quick-chill sprays during troubleshooting or stress testing procedures.

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Section 4 - Notices & Important Information

*MANDATORY EQUIPMENT*
The following equipment is mandatory, please refer to the relevant user
manuals for instructions in usage; blood oxygen monitor, CO2 alarm, blood
pressure alarm, ECG alarm, anesthesia agent concentration.

*SCAVENGING*
This machine is to be equipped with an anesthetic gas scavenging transfer
and receiving system, complying with ISO 8835-3 or applicable local standard
before being put into service.

*OXYGEN MONITOR*
If the integrated oxygen monitor is not installed, an oxygen monitor complying
with ISO 7767 shall be used when the anesthetic machine is used.

*CO2 MONITOR*
A CO2 monitor complying with ISO 9918 shall be used when the anesthetic
machine is in use.

BREATHING CIRCUIT
Adult breathing circuits with the anesthetic machines shall comply with ISO
8835-2.

*LEAKAGE CURRENTS*
Connection of equipment to the auxiliary mains socket outlets may increase
leakage currents to values exceeding the allowable limits.

Connection of the equipment to the socket outlets will increase leakage


currents. It is the users responsibility to ensure compliance to IEC 60601-1-1
(collateral standard for electrical medical systems). In the USA, equipment
connected to the socket outlets must comply with UL 60601-1 and the total
sum of the system leakage current shall not exceed 300 micro amps. It is the
USERs responsibility to ensure compliance with the above standard and that
the leakage current limits are not exceeded.

*GAS SUPPLY PRESSURE*


This equipment must only be connected to gas pipeline supply lines that are
installed with pressure relief valves that limit the supply pressure to less than
700kPa/max, (101.5psi/max).

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Section 4 - Notices & Important Information

*MRI ENVIRONMENTS*
The BleaseSirius machine and its absorber are not suitable for use in a MRI
environment.

LEAKAGE CURRENTS
Connection of the equipment to the socket outlets will increase leakage
currents. It is the users responsibility to ensure compliance to IEC 60601-1-1
(collateral standard for electrical medical systems). In the USA, equipment
connected to the socket outlets must comply with UL 60601-1 and the total
sum of the system leakage current shall not exceed 300 micro amps. It is the
USERs responsibility to ensure compliance with the above standard and that
the leakage current limits are not exceeded.

SEMICONDUCTOR DEVICES
The units use semiconductor devices which are susceptible to damage by
overloading, reversed polarity, electrostatic discharge and excessive heat or
radiation. Avoid hazards such as reversal of batteries, prolonged soldering,
strong RF fields, or other forms of radiation, use of insulation testers or
accidentally applied short circuits. Even the leakage current from an unearthed
soldering iron may cause trouble.

CYLINDERS
The cylinder should be cracked to ensure that no foreign material enters the
yoke when the cylinder is opened on a machine.

YOKES
To avoid stripping threads, do not use wrenches on the yoke bridge T screw.
Use only one cylinder gasket per yoke. Using more than one gasket could
cause cylinder gas leakage.

MANEUVERING MACHINE
When maneuvering machine with large cylinders attached, do not have either
the top monitor shelf or the vaporizer parking block loaded.

PIPELINE CONNECTIONS
The pipeline connections are not interchangeable, as they are installed with
gas-specific male NIST connectors (DISS on USA-specification machines).

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Section 4 - Notices & Important Information

OXYGEN MONITOR STABILIZATION


The oxygen monitor will need at least 10 minutes to stabilize after it has been
turned on. The transducer should always remain plugged into the machine to
ensure that it is ready for use.

SENSOR
Do not attempt to disassemble or modify the sensor.

VAPORIZER OPERATION
Refer to the vaporizer operating manual, before use, for filling, operating
and service instructions. The manual also contains information concerning
the extent to which the delivered vapor concentration is affected by changes
in ambient temperature and pressure, and accuracy and calibration details,
which should be understood before use. Vaporizers should not be used when
set between the OFF position (or the ZERO position if this is also the OFF
position) and the first graduation mark.

Do not use any vaporizer that is visibly misaligned on the manifold or that,
when it is locked, can be lifted off the manifold. Incorrect mounting may result
in incorrect delivery of gases.

A vaporizer is calibrated and labeled for one agent only. Do not fill with
anything other than the designated agent.

If a vaporizer is filled with the wrong agent, draining will not eliminate the
agent, because the wick will have absorbed some of the agent. The wick
must be thoroughly cleaned and dried by approved technical engineers. The
vaporizers must be completely upright for the sight glass to properly indicate
agent levels.

Never oil or grease any oxygen equipment unless the lubricant is made
and approved for this type of service. In general, oils and greases oxidize
readily, and - in the presence of oxygen - will burn violently. Fomblin is the
recommended oxygen service lubricant.

After performing any maintenance or repair procedure, always verify proper


operation of the system before returning to use.

Use cleaning solution sparingly. Do not saturate system components.


Excessive solution can damage internal devices.

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Section 4 - Notices & Important Information

VAPORIZER STERILIZATION
Following ethylene oxide sterilization, quarantine the equipment in a well
ventilated area to allow dissipation of absorbed ethylene oxide gas. In some
cases, aeration periods of seven days or more may be required. Aeration
time can be decreased when special aeration devices are used. Follow the
sterilizer manufacturers recommendations for aeration periods required.

WORK SURFACE FITTING


Only Qualified Technical Engineers are authorized to fit the extended work
surface assembly.

SAMPLE LINE
If a gas sample line is not in use, then replace white cap on the adult flow
sensor.

AGSS
The machine is to be equipped with an anesthetic gas scavenging system,
complying with ISO 8835-3 or applicable local standard before being put into
service.

PATIENT AIRWAY FLOW SENSOR


The patient airway flow sensor must be correctly installed at either the distal
location in the patient systems expiratory limb or the proximal end of the Y
connector. If the sensor is installed incorrectly, volume data will be inaccurate
and associated alarms, including the low minute volume alarm will not function
properly.

Position the patient airway flow sensor tubing with care. If the tubing is
pinched or cut, the ventilators volume monitoring may not function properly.

SUCTION CONTROLLER
Note there is no locking or securing mechanism.

ON/OFF SWITCH
Note the Oxygen/MED AIR power outlets are not switched on or off by the
machines On/Off switch.

STERILIZATION
Upon receipt of new machines, it is advisable to sterilize/clean all parts of the
BleaseSirius anesthesia machine before use.

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Section 4 - Notices & Important Information

*CHECKING OF EQUIPMENT*
The equipment must be periodically checked and maintained to ensure proper
operation.

CYLINDERS
In order to minimize the possibility of running the oxygen supply cylinders
down it is recommended that the machine be switched off when it is not in use.

HYPOXIC GUARD
Do not use the anesthesia system if the hypoxic guard control system does
not operate within permitted ranges. Using an incorrectly operating control
system may result in incorrect gas mixtures and injury to the patient.

As the machine has a hypoxic guard installed, the On/Off switch must be
turned to the Off position to reduce oxygen flow to zero. The O2 flow control
dial can only reduce the flow to 150ml/min 20ml/min.

Excessive force on the O2 or N2O control dials may damage the hypoxic guard
mechanism.

Excessive force will damage the hypoxic guard.

O2 FLUSH CONTROL
The O2 Flush control is non-locking.

EXCESSIVE FORCE
Excessive force applied to the control dials may damage the hypoxic guard.
To reduce the oxygen flow to zero, turn the On/Off switch to the OFF position.

GAS MIXTURES
25% is the minimum nominal mixture. The tolerance is 25-30% throughout the
range, except where N2O is set to 10.0 lpm when it is 25-35%.

The hypoxic guard control system only ensures that oxygen - nitrous mixtures
will have a minimum oxygen concentration. HYPOXIC MIXTURES MAY BE
DELIVERED IF GASES OTHER THAN OXYGEN, NITROUS OXIDE OR MED
AIR ARE USED, OR WHEN OPERATING AT LOW OXYGEN FLOW RATES.

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FRESH GAS FLOW


Maintain sufficient fresh gas flow when using Sevoflurane.

*COMPATBILITY*
The performance of the anesthetic machines and vaporizers may be degraded
if the two are mismatched. Refer to the vaporizer manufacturers instruction
manual before use.

CLEANING
Some anesthetic agents may adversely affect the paintwork. Any spillage
should be removed immediately.
Rubber and plastic parts of the machine can be cleaned with a mild detergent
and a soft cloth.

*ALARM PRE-USE CHECKS*


Prior to connecting the machine to the patient carry out the pre-use check to
verify correct alarm operation. To verify the O2 alarm, set the flowmeters to
give a concentration of 50% oxygen. Using the controls on the oxygen monitor
panel, set the low oxygen level to 60% and verify the oxygen low alarm
operates. Set the high oxygen alarm level to 40% and verify that the oxygen
high alarm operates.

*VAPORIZER COMPLIANCE*
Any vaporizer installed on the anesthetic machine shall comply with ISO
8835-4. Additionally while the vaporizer is in use an anesthetic agent monitor
complying with ISO 11196 is to be used.

VOLUME SENSING PRE-USE CHECK


Always perform the pre-use check procedures for volume sensing functions
after cleaning or replacing the volume sensor.

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BleaseSirius Cautions

SALE OF DEVICE
Federal law restricts this device to sale by or on the order of a physician.

SECURE SHELVING
Secure any equipment placed on shelves.

OVERLOADING
Overloading may cause damage to the shelves or cause instability.

GAS CYLINDER VALVES


Do not leave gas cylinder valves open if the pipeline supply is in use and
the system master switch is turned ON. Pressures from both supplies may
become equal and, if simultaneously used, cylinder supplies could become
depleted, leaving an insufficient reserve supply in case of pipeline failure.

PIPELINES
The input to the machine pipelines should be regulated to 275-482kPa (40-
70psi). To ensure the cylinder supply is only used as a backup, the pressure
should be regulated to a lower pressure than primary pipeline.

FRESH GAS FLOW


Maintain sufficient fresh gas flow when using Sevoflurane.

FLOW SENSOR TUBING


Check flow sensor tubing regularly for trapped water as it could affect
ventilator readings.

DAMAGE TO INTERNAL COMPONENTS


Excessive penetration of fixing screws into the ventilator may damage internal
components. Ensure that the screws do not penetrate more than 7mm/0.2
into the ventilator.

MANEUVERING ANESTHETIC MACHINE


When maneuvering the anesthetic machine, ensure brake pedal is released
and that you only use the following identified handles.

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HIGH PRESSURE
When using external patient circuits, there is possible risk of high pressure.

LEAKING GASES
Leaking gases and vapors (downstream of the flow control valves and oxygen
flush valve) may deprive the patient of metabolic gases and anesthetic agent
may pollute the atmosphere. Tests that detect leaks must be preformed
frequently. If detected, leakage must be reduced to an acceptable level.

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BleaseSirius Notes
USER RESPONSIBILITY
The user must be familiar with the machine and its various functions before
using it on a patient.

USER RESPONSIBILITY
Keep this manual with the system to refer to and to answer any questions that
arise about the systems operation, maintenance or, if necessary, repair.
All pictures shown in this manual are of the BleaseSirius machine.

ESD
Electronic assemblies in the BleaseSirius range of machines are easily
damaged by ESD and require special handling.

MAINS SUPPLY
In US markets a cord fitted with a NEMA 5-15 hospital grade plug should be
used to connect the BleaseSirius to the mains supply.

GROSS LOADING
Gross loading = 250kg/551.1lbs

PRESSURE MEASUREMENT
The units of pressure measurement can be expressed in either cmH2O or hPa.

CYLINDERS
To prevent leakage from the cylinder valve gland nut, keep the cylinder valves
shut when not in use.

OXYGEN SENSOR
The oxygen sensor measures the concentration of oxygen in the patient
circuit.

VAPORIZER MANUAL
Refer to the vaporizer operating manual for filling and operating instructions.

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BREATHING CIRCUIT WITH FILTER


Incorrect and correct ways of setting up breathing circuit with filter. Care must
be taken to ensure that the sensor is not contaminated by moisture and the
patient circuit doesnt produce jetting effect onto sensor.

OXYGEN FAILURE ALARM


If the oxygen supply fails the nitrous oxide will shut off and an Oxygen Failure
Alarm will sound. The ventilator will also be supplied with MED AIR as an
emergency driving gas. Restoration of the oxygen supply will automatically
return gases to their defaults.

The system will also give an alarm on the ventilator if oxygen fails.

OUTLETS
An additional auxiliary MED AIR or oxygen outlet with a barbed fitting is
available to provide flow of up to 80 lpm max up to max 400kPa/58.0psi at 0
flow.

FLOWMETER BACKLIGHT
Function of the flowmeter backlight is to illuminate readings on the mechanical
fresh gas flowmeter tubes. It is possible to disable this feature in the software.
The backlight is not available if your system has the electronic flowmeter
(EFM).

FULL SYSTEM TEST


At the end of the Pre-use check, you are given the option to perform a full
system test. Although not necessary to do each time the machine is turned on,
we recommend it be done once a month.

OXYGEN FAIL ALARM


The system will also give an alarm on the ventilator if oxygen fails.

CHECKLISTS
We recommend that you refer to recommendations of your local professional
association regarding checklists, Spacelabs Healthcare instructions are
provided in section 1.9.

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Ventilator Warnings

DRIVE GAS EXHAUST


Do not block the drive gas exhaust, because this may lead to the ventilator not
functioning correctly.

SHORT INSPIRATORY TIMES


Short inspiratory times may result in inconsistent breath delivery. Avoid control
combinations which may produce very short inspiratory times (<150ms).

PRESSURE LIMITING
Pressure limiting is a safety feature and is also used in adult and pediatric
mode to provide ventilation (Precision Pressure Control). It should not be
used for any other purpose, such as creation of micro-breaths or emulation of
specialized high frequency/low volume ventilation systems, otherwise injury to
the patient may result.

SIMV MODES
The SIMV modes use a flow trigger to sense the patient attempt to breath.
Therefore, the SIMV modes will not work with patient sensor placed at the
absorber.

VTE MEASUREMENTS
Periodically check that VTE measurements match expected delivery.

INSPIRATORY TIMES
Short inspiratory times may result in inconsistent breath delivery. Avoid control
combinations which may produce very short inspiratory times (<150ms).

PRESSURE LIMITING
Pressure limiting is a safety feature and is also used in adult and pediatric
mode to provide ventilation (Precision Pressure Control). It should not be
used for any other purpose, such as creation of micro-breaths or emulation of
specialized high frequency/low volume ventilation systems, otherwise injury to
the patient may result.

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PATIENT CIRCUIT DISCONNECTION


Patient circuit disconnection is a hazard to the patient. Take extreme care to
prevent such an occurrence.

Monitored values require a few minutes to stabilize after initial activation. The
ventilator and set values will function correctly.

SENSOR TUBING
The patient airway flow sensor must be in the patient breathing circuit (see
section 2.2.18 for positioning) and the associated sensor tubing must not
be trapped, kinked, split or damaged in any way in order to ensure correct
performance.

A.C.G.O. WARNING
The ventilator displays the warning A.C.G.O. while the auxiliary common gas
outlet is in use. If the A.C.G.O. switch is activated during ventilation, the ven-
tilator will continue for about 10 seconds before switching over. To reactivate
the ventilator, switch to Bag mode, then back to Vent mode.

AUDIBLE ALARM
An audible alarm indicates an anomalous condition that may result in damage
to the equipment or injury to the patient. The cause of each alarm should
be investigated and any necessary measures taken to remove the alarm
condition.
The pressure high and pressure low alarms are important for patient care.
If an alarm condition cannot be resolved, do not use the system.

REDUCED MINUTE VOLUME


If the supply gas pressure is reduced, the patient minute volume may be
reduced and injury to the patient could result. Do not use the ventilator if the
supply pressure cannot be maintained.

VENT INOPERATIVE ALARM


The Vent Inoperative alarm indicates that the ventilator cannot provide
ventilation functions. Under no circumstances should the ventilator be used on
a patient while this alarm is activate.
If a Vent Inoperative alarm occurs, contact Spacelabs Healthcare Global
Technical Support or your local Spacelabs representative.

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ALARM SETTING
Alarms should not be set to extreme values that can cause the alarm system
to function improperly.

ALARM MUTE
Do not attempt to use the ventilator if the alarm mute button does not silence
alarms.

RECALLING SETTINGS
When recalling previously saved settings, always ensure that the settings and
alarm limits are clinically appropriate for use.

OXYGEN SENSOR
The oxygen monitor requires at least 10 minutes to stabilize after it has been
turned on. The transducer should always remain plugged into the machine to
ensure that it is ready to use.

The equipment must be periodically checked and maintained to ensure proper


operation.

Prior to connecting the machine to the patient, carry out the pre-use check to
verify correct alarm operation. To verify the O2 alarm, set the flow meters to
give a concentration of 50% oxygen. Using the controls on the oxygen monitor
panel, set the low oxygen level to 60% and verify the oxygen low alarm
operates. Set the high oxygen alarm level to 40% and verify that the oxygen
high alarm operates.

Always perform the pre-use check procedures for volume sensing functions
after cleaning or replacing the volume sensor.

OXYGEN MONITORING
If you remove the Oxygen parameter from the Measurements area on the
Normal screen, the pre-defined O2 concentration alarms remain active. If you
will use an alternate O2 monitoring device, you can disable O2 monitoring and
alarms via a password protected area in the Service Mode. Contact your local
Spacelabs representative for more information.

If the O2 measurement displays a dashed line in the Measurements area and


the O2 alarm setting reads Disabled, O2 monitoring is disabled. You enable
O2 monitoring via a password protected area in the Service Mode. Contact
your local Spacelabs representative for more information.

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Section 4 - Notices & Important Information

FLOW SENSOR
Do not attempt to disassemble or modify the sensor. If the sample line on the
sensor is not in use, replace the white blanking cap on the flow sensor.

The patient airway flow sensor must be correctly installed at either the distal
location in the patient systems expiratory limb or the proximal end of the Y
connector. If the sensor is installed incorrectly, volume data will be inaccurate
and associated alarms, including the low minute volume alarm, will not
function properly.

FLOW SENSOR
Position the patient airway flow sensor tubing with care. If the tubing is
pinched or cut, the ventilators volume monitoring may not function properly.
Upon receipt of new machines, sterilize/clean all parts of the machine before
use.

PRE-USE CHECKS
Prior to connecting the machine to a patient carry out the pre-use check to
verify correct alarm operation. To verify the O2 alarm, set the flowmeters to
give a concentration of 50% oxygen. Using the controls on the oxygen monitor
panel, set the low oxygen level to 60%.

BELLOWS PRESSURE
At pressures above 10cmH2O differential positive pressure, the bellows may
be dislodged from the mounting ring, resulting in a dangerous malfunction of
the ventilator. Do not exceed the stated pressure.

ELECTRIC SHOCK HAZARD


Lethal voltages are present within this equipment when it is connected to
the mains electrical supply. Do not remove any of the ventilator covers or
panels. Refer all repairs and servicing to an authorized Spacelabs Healthcare
technical engineer.

VENTILATOR MALFUNCTION
Injury to the patient may result if a faulty ventilator is used. If there is any
malfunction, do not use the ventilator. Refer to the Ventilator Troubleshooting
section for help. If the malfunction cannot be rectified, contact Spacelabs
Healthcare Global Technical Support or your local Spacelabs representative.

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Section 4 - Notices & Important Information

LIQUID INGRESS
Ingress of liquid into the control unit may damage the unit or result in injury to
personnel. Ensure that no liquid enters the control unit, and always disconnect
the unit from the mains electrical supply before cleaning.

LCD SCREEN CLEANING


Do not clean the LCD Screen with liquid.
Use only a dry, soft, lint-free cloth to clean the LCD screen.

CLEANING OF PATIENT AIRWAY FLOW SENSOR AND TUBING


Following cleaning and sterilization of patient airway flow sensor and flow
sensor tubing, ensure that no liquid is present in the tubes. Perform the Pre-
use check.

BELLOWS COVER - PEDIATRIC


Unlike the adult bellows cover, you cannot autoclave the pediatric bellows
cover. The pediatric bellows cover should never need to be disinfected.
However, if required, you can disinfect the pediatric bellows cover using
non-alcohol surgical wipes. You can also gas sterilize the pediatric bellows
(with Ethylene Oxide, 54oC) and cold sterilize (using Sporicidin or Sonacide).
Alcohol or chlorine based cleaning agents must not be used to disinfect the
pediatric bellows cover.

BELLOWS CLEANING
Sterilize the bellows assembly periodically to minimize the risk of cross
infecting patients. Follow a sterilization schedule that complies with your
institutions infection control and risk management policy. Only use Spacelabs
Healthcare approved sterilization methods.

Foreign materials or liquids trapped in the driving gas circuit, the pop off valve
or the bellows base can impair the valve operation. Do not use the bellows
assembly if you suspect that materials are trapped. Have the assembly
repaired by a qualified Spacelabs Healthcare technical engineer.

Perform the Pre-use Check procedures after cleaning and sterilizing the
bellows.

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Section 4 - Notices & Important Information

Ventilator Cautions
BATTERY LIFE
To preserve battery life, never store the ventilator with its battery discharged.
Do not store the ventilator in close proximity to heat sources of any kind.

A.C.G.O.
100% oxygen calibration is NOT available when the machine is in A.C.G.O.
(see section 2.2.13).

SOCKET CONNECTIONS
Connection of equipment to the auxiliary mains socket outlets may increase
leakage currents to values exceeding the allowable limits.
Connection of the equipment to the socket outlets will increase leakage
currents. It is the users responsibility to ensure compliance to IEC 60601-1-1
(collateral standard for electrical medical systems). In the USA, equipment
connected to the socket outlets must comply with UL 60601-1 and the total
sum of the system leakage current shall not exceed 300 micro amps. It is the
USERs responsibility to ensure compliance with the above standard and that
the leakage current limits are not exceeded.

When using external patient circuits, there is a possible risk of high pressure.

RECALL SETTINGS CHECK


Check that the settings on screen are correct after you recall them.

EXPLOSION HAZARD
An explosion hazard could occur if this equipment is used with flammable
anesthetic agents such as ether or cyclopropane. To avoid the risk of
explosion, use this equipment only with anesthetic agents that comply with
the requirements on non-flammable anesthetic agents in the IEC 60601-2-13
Particular Requirements for the Safety of Anesthetic Machines.

DRIVING GAS
Use of a driving gas other than oxygen or MED AIR may damage the ventilator
and will cause inaccurate operation, resulting in potential injury to the patient.
Only use oxygen or MED AIR as the driving gas.

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Section 4 - Notices & Important Information

OPERATING TEMPERATURE
The performance of this equipment may be adversely affected by extremes of
temperature. The equipment should not be used if the ambient temperature is
below 10C (50F) or above 40C (104F).

ANTISTATIC OR ELECTRICALLY CONDUCTIVE BREATHING TUBES


The use of antistatic or electrically conductive breathing tubes and high
frequency electric surgery equipment may cause burns and is therefore not
recommended in any application of this machine.

The ventilator is not suitable for use with flammable anesthetic agents, such
as ether and cyclopropane, and therefore the use of antistatic breathing tubes
and face masks is unnecessary.

This equipment may be damaged if the gas supply pressure is too high.
The ventilator must only be connected to gas pipeline supply lines that are
fitted with pressure relief valves that limit the supply pressure to less than
700kPa/101.5psi.

HIGH FREQUENCY SURGICAL EQUIPMENT


The ventilator may be adversely affected by the operation of equipment, such
as high frequency surgical (diathermy) equipment, defibrillators or short-wave
therapy equipment in the vicinity.

POWER FAILURE
In the event of a mains electrical power failure when the ventilator is running
from its internal battery, do not remove the mains plug from the mains supply
as this would prevent the immediate resumption of normal operation when the
mains power is restored.

ELECTROMAGNETIC INTERFERENCE
Excessive electronic noise caused by poorly regulated devices may interfere
with the proper functioning of the ventilator. To avoid electronic noise, do not
connect the ventilator to the same mains supply outlet as electrically noisy
equipment such as electrocautery units. Do not use a mains extension lead to
connect the ventilator to the mains electrical supply.

Normal operation of all equipment should be verified in your configuration


before clinical use. If interference is encountered, ensure all equipment is
connected following manufacturers recommendations.

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Section 4 - Notices & Important Information

EXHAUST GAS
The driving gas is discharged through the port on the rear panel of the
ventilator. This port must be completely free of any obstruction and should
have nothing connected to it. The exhaust gas is oxygen or MED AIR and
does not contaminate the environment.

BELLOWS EXHAUST
A negative or positive pressure applied to the EXHAUST port of the bellows
assembly results in positive pressure in the patient breathing system. The
scavenging system must therefore not generate more than 5cmH2O of positive
or negative pressure when connected to the ventilator.

The use of an AGSS to EN 740 1999 is recommended. Do not connect a


PEEP valve to the EXHAUST port of the bellows base. This will increase the
pressure inside the bellows and cause it to detach from the base, resulting
in a serious malfunction. Any problem arising from an improperly functioning
scavenging system is solely the responsibility of the user.

Improper connection of equipment or any power sources to the calibration port


may permanently damage the ventilator. Only an approved technical engineer
should connect monitoring equipment to this port. Such equipment must be
Spacelabs Healthcare compatible and meet the regulatory standards of the
countries in which the ventilator is used.

VENTILATOR FAULTS
Injury to the patient may result if a faulty ventilator is used. If there is any
malfunction, do not use the ventilator. Refer to the Troubleshooting section
for help. If the malfunction cannot be rectified, contact Spacelabs Healthcare
Technical Support or your local Spacelabs representative.

ALARM OPERATION
If an alarm condition is ignored, injury to the patient may result. Always check
the alarms before connecting the ventilator to a patient. If the audible alarm
or the visual indicator of any alarm function fails to activate during an alarm
condition, or fails to reset after the alarm has been cleared, do not use the
ventilator. Contact an authorized technical engineer.

CLEANING AGENTS
The ventilator surfaces are not scratch-resistant. Do not use abrasive cleaning
agents that may damage the surfaces.

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Section 4 - Notices & Important Information

AUTOCLAVING SENSOR
If you are autoclaving the sensor, follow autoclave manufacturers directions.
Temperature are not to exceed 134C.

BLANKING CAP
Blanking cap on the patient flow sensor is NOT autoclavable.

STERILIZATION (BELLOWS)
Only the bellows base and the parts inside the bellows require sterilization.
To avoid damage to the equipment:
Peak sterilization temperature must not exceed 134C.
Do not sterilize the control unit.
Gas sterilization should be followed by quarantine in a well-ventilated
area to allow dissipation of residual absorbed gas.
Follow the sterilization agent manufacturers instructions.
Pop-off valve must be autoclaved separately.

VALVE SEAT
If the valve seat is damaged, the pop-off valve will leak and may cause serious
malfunction. Take care not to damage the precision-molded surface of the
valve seat while cleaning. Never use a hard object or abrasive detergent to
clean the valve. Use only a soft, lint-free cloth.

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Section 4 - Notices & Important Information

Ventilator Notes

CALIBRATION PORT
Improper connection of equipment or any power sources to the calibration port
may permanently damage the ventilator. Only an approved technical engineer
should connect monitoring equipment to the recorder output. Such equipment
must be Spacelabs-compatible and meet the regulatory standards of the
countries in which the ventilator is used.

VENTILATOR FEATURES
Some features of the ventilator are only available in certain ventilatory models.

SAFETY VALVE
A safety valve is present in the drive pressure exhaust 75cmH2O. Its function
is to protect the patient against pressures exceeding 75cmH2O 2cmH2O by
relieving the drive pressure on the bellows.

NEEP
NEEP is not supported by this machine, but patient-generated pressures may
be measured to - 10cmH2O at which point an alarm will sound.

TRAK WHEEL AND TOUCHSCREEN USAGE


The selection is cancelled if the Trak Wheel is not moved for approximately 5
seconds.
Be sure to use your fingertip to activate the touchscreen, do not use pens or
pencils or any other sharp instruments as these will damage the touchscreen.
If the confirm button is not pressed the old value will be restored.
Combination of both touchscreen and Trak Wheel can be used.

BATTERY STATUS
Additional battery status information (Volts) may be obtained from the System
Information screens - See Section 2.2.27.9.

PRE-USE TESTING
Please read the following instructions in conjunction with the information on
Compliance compensation contained in the Installation Section 2.3.4.2 of this
manual.

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Section 4 - Notices & Important Information

CHECKLISTS
Refer to recommendations of your local professional association regarding
checklists.

PRE-USE CHECK
At the end of the Pre-use check you can choose to perform a full system test.
Although not necessary to do each time machine is turned on, it should be
done once a month.

PRE-USE TEST
During the pre-use test, the second stage pressure rise has been increased
from 20cmH2O to 40cmH2O.

The on-screen steps are just a set of instructions and not an active test. Set
the controls as instructed and carry out the manual test as instructed making
the necessary observations that all is working as correctly.

CONNECTIONS
A leak detection error can be caused by fitting a Re-Breathing bag to the
Y connector instead of occluding the circuit on the plug provided on the
absorber.

OXYGEN CALIBRATION
O2 Calibration is only possible if the ventilator is in Standby and an O2 probe is
connected.

To prevent inaccurate calibration, the ventilator software verifies that the


correct percentage of oxygen is present for the selected calibration point.

O2 Calibration is only possible if the oxygen percentage parameter is selected


and a probe is connected.

CONFIGURATION
The features available will depend on the operating mode.

PATIENT MODES
The patient mode can only be changed while the ventilator is in BAG or
Standby mode and not in run mode.

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Section 4 - Notices & Important Information

SENSOR
The sensor measures inspired and expired flow into and from patient. It also
measures pressure in patient airway.

SENSOR BUTTON
You can only change the sensor placement location in standby mode and not
in run mode.

PATIENT FILTER
A patient filter is recommended but not essential since all parts in the patient
circuit may be sterilized. (Refer to section 1.4.8.1 for filter placement).
All Y circuit tubing must conform to ASTM F-1205.

MODE SELECTION MENU


If the Trak Wheel is not moved for approximately 30 seconds, the display
automatically returns to the main screen.

Before changing the ventilation mode when the ventilator is in run mode, you
will see a prompt to confirm or adjust the main parameter for that mode.

ALARMS
Check alarms periodically at clinically suitable intervals. If the audible alarm
or visual indicator of any alarm function fails to activate during any alarm
condition, or fails to reset after the alarm has been cleared, refer the unit to an
authorized technical engineer.

ALARMS
In the Alarms Summary (Section 2.2.24.1), alarms marked with a (*) are
inhibited for 20secs, when the ventilator mode is changed.

LOW PRESSURES
Due to the connection with the pressure limit control, it is possible with some
patients that the alarm may occasionally be activated when pressure limiting
at low pressures in the pediatric mode. The alarm is automatically cleared
when the pressure rises.

OXYGEN ALARM
The system will also sound an alarm on the ventilator if the oxygen fails.

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Section 4 - Notices & Important Information

ALARM INDICATORS
Alarms are indicated by a change in color of the LED adjacent to the display.
Under normal conditions the LED will be GREEN.

POWER FAIL AND INTERNAL BATTERY ALARMS


This is an estimated time and should not be relied on.

APNEA ALARM
If apnea is registered at approximately 5mins in BAG mode and there is no
flow detected, the machine will automatically go into STANDBY.

AUTO ALARMS
If the user displays the Set Alarms Menu while the auto alarms are set, the
previous values will be restored without warning.

The user can restore the previous set of alarm limits at any time by either
selecting Off in the auto box, or going into the Alarm Limits Menu and making
no changes.

SETTING ALARMS
High and low alarms are linked intelligently so that a low alarm value greater
than a high alarm value cannot be set.

Only those alarms that are relevant to the current operating mode are
displayed.

DEFAULTS MENU
Settings and hospital defaults can be stored in Adult or Pediatric mode.
Ensure that the Patient Selection Switch is in the required position before
selecting these items.

SAVING AND RECALLING SETTINGS


Two totally different sets of parameters can be set up - one for Adult and one
for Pediatric under each settings name.

CHANGE NAMES
A user name must be entered before any settings can be saved.

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Section 4 - Notices & Important Information

SERVICE MENU
These options are password protected. Contact Spacelabs Healthcare
Technical Support or your local Spacelabs representative for more information.

FRESH GAS CALIBRATION


The CGO of the trolley must be open to atmosphere for the calibration to be
accurate.

SYSTEM AUDIT TRAIL


To access System Audit information, contact your local Spacelabs Healthcare
representative.

PRE-USE CHECKS
Prior to connecting the ventilator to a patient, the unit must be run to verify that
it is functioning correctly. Before using the ventilator, check that all connections
are correct and that there are no leaks.
Other alarms may also be activated, i.e., sustained pressure.

COMPLIANCE
To calculate the effect of breathing system compliance on the delivered TV, it
is necessary to measure the capacity or compliance (Cs) of the system. This
can only be done as part of a pre-use check procedure.

PATIENT AIRWAY FLOW SENSOR


The patient airway flow sensor head must be in the patient circuit to carry out
compliance compensation.

REFITTING POP- OFF VALVE


When refitting pop-off valve, ensure that thumb screws are evenly tightened -
finger tight only.

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Section 4 - Notices & Important Information

Absorber Warnings

ABSORBER ORIENTATION
Use the absorber only in the upright position. Use in any other orientation may
affect the gas flow or damage the absorber.

SODA LIME
Soda Lime is caustic. Observe the manufacturers instructions for correct
handling and storage. When handling soda lime, always wear suitable eye,
face and hand protection, as crushed soda lime can degrade to a fine dust
which may be harmful by inhalation.

To minimize the levels of soda lime dust, ensure that the soda lime is not
crushed and that regular cleaning of the absorbers and breathing circuits is
carried out.

To prevent injury to the patient, always protect the patients face using a
facemask.

FILLING CANISTERS
Under filling of canisters can lead to inefficient CO2 absorption. Overfilling can
result in poor canister sealing. Fill the reusable canisters only to recommended
level.

CONDENSATE
The condensate in the bottom of the canister is caustic. Drain it periodically.
Accidental splashes should be rinsed immediately with water.

REFILLING SODA LIME CANISTER


When refilling the absorber canister with soda lime, there have been instances
when the upper seal has not been replaced resulting in a leak. This seal is
located above the upper soda lime canister attached to the molding within the
body of the absorber. Ensure that all seals are correctly replaced when re-
assembling the absorber.

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Section 4 - Notices & Important Information

DESICCATED ABSORBENT
Desiccated (dehydrated) absorbent material may produce dangerous chemical
reactions when exposed to inhalation anesthetics. Adequate precautions
should be taken to ensure that absorbent does not dry out. Turn off all gasses
when finished using the system.

DISPOSABLE CANISTERS
Amsorb The canister seal must be removed PRIOR to use in a BleaseSirius
Absorber.

ABSORBER MALFUNCTION
Injury to the patient may result if a faulty absorber is used. If there is any
malfunction, or if the absorber does not pass all pre-use tests, do not use
the absorber - injury to the patient may result. Contact Spacelabs Healthcare
Technical Support or your local Spacelabs representative.

SPONTANEOUS BREATHING
If the APL valve is not in the OPEN position, it will not operate until the
pressure reaches approx 65cmH2O. To allow Spontaneous breathing, set the
APL valve to OPEN.

CAUSTIC CONDENSATE
The condensate in the bottom of the outer canister is caustic. Drain it
periodically. Accidental splashes should be rinsed immediately with water.

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Section 4 - Notices & Important Information

Absorber Cautions

CAUSTIC CONDENSATE
The condensate in the bottom of the outer canister is caustic. Drain it
periodically. Accidental splashes should be rinsed immediately with water.

DISPOSABLE CANISTERS
Only the following disposable canisters have been tested and shown to seal
correctly and are therefore approved for use with Spacelabs Healthcare
Anesthesia equipment. Checking for a correct seal with any manufacturers
disposable canisters is the responsibility of the user. Please contact Spacelabs
Healthcare for advice if in any doubt.
Intersurgical The Drum
GE MediSorb Pre-packed cartridge disposable.
Allied Healthcare Carbolime.
Armstrong MedicalAmsorb (canister seal must be removed)

OCCLUDING BREATHING SYSTEM


When occluding the breathing system for test purposes, do not use any object
small enough to slip completely into the system. Objects in the breathing
system can interrupt or disrupt the delivery of breathing system gases,
possibly resulting in injury to the patient. Before using the breathing system on
a patient, always check the breathing system components for foreign objects.

POP-OFF VALVE AND BELLOWS


Take care when filling the bellows for pre-use testing, etc, as over filling via the
flush control will result in the bellows rising rapidly and hitting the top of the
canister. This results in the valve opening fully and the visible swelling of the
bellows, this excess pressure will then take a moment to dissipate through the
revised exhaust path resulting in the valve remaining slightly open, which may
result in the bellows dropping slightly giving the impression of a leak.

Therefore, when filling the bellows, use the flush control to bring the bellows
up to within 25mm/1inch of the top of the canister and then allow the
flowmeter/fresh gas flow to bring the bellows up to its full extent.

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Section 4 - Notices & Important Information

CLEANING
Do not use caustic substances such as trichlorethylene for cleaning the
absorber, as it may damage the surfaces.

STERILIZATION
Do not autoclave the manometer.

MANOMETER
Sterilization will damage the manometer - Remove it before sterilizing the
absorber.

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Section 4 - Notices & Important Information

Absorber Notes

ABSORBER USEAGE
Read Section 3 of this manual before operating the absorber.

CONDENSATE
Gas flows between the inner and outer canisters will, under some conditions,
cause condensation on the inside of the outer canister. This condensation is
normal and does not interfere with normal function of the absorber.

CANISTER ASSEMBLY
When filling a canister, pour the soda lime carefully and steadily. Gently tap
the sides to settle the granules and carry on filling until the canister is almost
full. Do not tap the canister violently because this will create dust.

PRESSURE MEASURING DEVICE


A suitable pressure measuring device is required for the absorber leak test.

LEAK TEST
These instructions assume that you have performed the absorber leak test
immediately prior to this test.

EXTERNAL MONITORING
It is recommended that some external monitoring of O2 , CO2 and anesthetic
agent are used when the absorber is used with a ventilator.

ABSORBER STERILIZATION
Other than stated, the components and materials of the absorber are
compatible with autoclaving and Ethylene Oxide sterilization processes.

AUTOCLAVING
Autoclave the canisters and separate plastic parts in an upright position and
away from other components.

APL ALIGNMENT
Ensure the APL valve remains vertical during re-fitting, by aligning the scallop
in the cover edge with the cover stop before engaging the bayonet fitting.

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Section 4 - Notices & Important Information

OXYGEN SENSOR
The oxygen sensor measures the concentration of oxygen on the patient
circuit.

WARRANTY
During the warranty period, if the equipment is serviced by an unauthorized
party, the warranty will be void.

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Section 4 - Notices & Important Information

Glossary
Term Definition
Apnea Apnea occurs when the patient fails to receive
or perform a breath during a period of 30
seconds or as set.
Compliance Compensation for back pressure.
Pause When Pause is activated, a percentage of the
inspiratory time is used as a plateau before
starting the expiratory phase.
Precision Pressure Control Precision pressure control ventilation
Pressure Support Pressure support ventilation
Sigh If Sigh is selected, the delivered volume
is increased by 10% for every 10th breath
(volume ventilation only).
Volume Control Controlled mandatory ventilation
l

BleaseSirius User Manual 245


Appendix 1: EMC Compliance Tests

Appendix 1: EMC Tests for IEC 60601-1-2 Compliance


The BleaseSirius Anesthetic System is suitable for use in the specified electromagnetic
environment. The user of the BleaseSirius Anesthetic System should assume that it is
used in an electromagnetic environment as described below. Changes or modifications
to this system, not expressly approved by Spacelabs Healthcare, could result in EMC
issues with this system. Contact Spacelabs Healthcare for more information.

The use of mobile phones or RF emitting equipment near the system may cause
adverse operation. Use of electrical equipment near this system may cause
interference. Always monitor system operation before and during use on a
patient.

Emissions
Emissions Test Compliance Electromagnetic Environment Guidance

RF Emissions Group 1 The system uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF Emissions Class A The system is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic Emissions Class A
IES 61000-3-2

Voltage Fluctuations/ Complies


Flicker Emissions
IEC 61000-3-3

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Appendix 1: EMC Compliance Tests

Power Immunity
Immunity IEC 60601-1-2 Compliance Electromagnetic
Test Test Level Level Environment Guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete
Discharge 8 kV air 8 kV air or ceramic tile. If floors are
(ESD) IEC covered with synthetic material,
61000-4-2 the relative humidity should be
at least 30%.
Electrical Fast 2 kV for power 2 kV for power Mains power quality should be
Transient/Burst supply lines, supply lines, that of a typical commercial and/
IEC 61000-4-4 1 kV for input/out- 1 kV for input/out- or hospital environment.
put lines put lines
Surge IEC 1 kV differential 1 kV differential Mains power quality should be
61000-4-5 mode mode that of a typical commercial and/
2 kV common 2 kV common or hospital environment.
mode mode
Voltage Dips, < 5% UT (> 95% dip < 5% UT (> 95% dip Mains power quality should be
Short Inter- that of a typical commercial and/
in UT) for 0.5 cycle in UT) for 0.5 cycle
ruptions and or hospital environment. If the
Voltage Varia- 40% UT (60% dip in 40% UT (60% dip in system user requires continued
tions on Power UT) for 5 cycles UT) for 5 cycles operation during power mains
Supply Input interruptions, it is recommended
Lines IEC 70% UT (30% dip in 70% UT (30% dip in that the system be powered
61000-4-11 UT) for 25 cycles UT) for 25 cycles from an uninterruptible power
< 5% UT (> 95% dip < 5% UT (> 95% dip supply or a battery.
in UT) for 5 sec. in UT) for 5 sec.
Power Fre- 3 A/m 3 A/m Power frequency magnetic fields
quency (50/60 should be at levels characteristic
Hz) Mag- of a typical location in a typical
netic Field IEC commercial or hospital environ-
61000-4-8 3 ment.

Note: UT is the AC mains voltage before application of the test level.

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Appendix 1: EMC Compliance Tests

Radiated Immunity
Immunity IEC 60601-1-2 Compliance Electromagnetic Environment
Test Test Level Level Guidance Recommended
Separation Distance
Portable and mobile RF communications
equipment should be used no closer to
any part of the system, including cables,
than the recommended separation
distance calculated from the equation
appropriate for the frequency of the
transmitter.
Recommended Separation Distance:
Conducted 3 Vrms 10 Vrms (V1) d = (3.5/V1) P
RF IEC 150 kHz to 80 MHz
61000-4-6 A.M. Modulated
with 2Hz at an
80% Depth, 10 Vrms (V2) d = (12/V2) P
outside ISM bandsa

10 Vrms
150 kHz to 80 MHz
A.M. Modulated
with 2Hz at an
80% Depth,
in ISM bands
Radiated RF 10 V/m 10 V/m (E1) d = (12/E1) P (80MHz to 800MHz)
IEC d = (23/E1) P (800MHz to 2.5GHz)
61000-4-6 80 MHz to 2.5 GHz
A.M. Modulated
with 2Hz at an Where P is the maximum output power
80% Depth rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).b
Field strengths from fixed RF transmit-
ters, as determined by an electromag-
netic site survey,c should be less than
the compliance level in each frequency
range.d
Interference may occur in the vicinity
of equipment marked with the following
symbol:

Note 1: At 80 MHz to 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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Appendix 1: EMC Compliance Tests

a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz
to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70
MHz.

b
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that a portable
communications device could cause interference if it is inadvertently brought into patient areas.
For this reason, an additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in these frequency ranges.

c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the system is used exceeds the applicable RF compliance
level above, the system should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the system.

d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

Recommended Separation Distances Between Portable &


Mobile RF Communications Equipment and the BleaseSirius
System
The system is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the system can help pre-
vent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the system as recom-
mended below, according to the maximum power of the communications equipment.

Separation Distances in Meters (m) According to the Frequency of the Transmitter


Rated Maximum 150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
Output Power of MHz MHz MHz GHz
Transmitter Outside ISM In ISM Bands
Watts (W) Bands

d = 0.35/(P) d = 1.2/(P) d = 1.2/(P) d = 2.3/(P)

0.01 0.04 0.12 0.12 0.23


0.1 0.11 0.38 0.38 0.73
1 0.35 1.20 1.20 2.30
10 1.1 3.8 3.8 7.3
100 3.5 12.00 12.00 23.0

BleaseSirius User Manual 249


Appendix 1: EMC Compliance Tests

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

Note 1: At 80 MHz to 800 MHz the separation distance for the higher frequency range applies.

Note 2: The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance
for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equip-
ment could cause interference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

250 BleaseSirius User Manual


Index

Index APL Valve 201


APL Valve Test 195
Apnea Alarm 141
Auto Alarms 143
Auxiliary Flowmeter 71
Symbols Auxiliary Outlet Test 81
700/900 Series Ventilators 83
B
A Bag 117
Abbreviations 22 Bag/Vent switch 186
Absorbent 187 Battery Back Up 87
Absorbent Capacity 197 Battery Status LEDs 104
Absorber 48, 183 Bellows 161, 164
Description 186 Blanking Plug 205
Installation 189 BleaseSirius 21
Introduction 186 Brake Pedal 72
Absorber Not Fitted 116, 137 Breathing Control 175
absorber service kit 203 Breathing modes 174
Accessories 172, 204 Bypass valve 186
A.C.G.O 123
Activity Display Area 100 C
Adult 123 Cal Error 137
Adult Bellows 158 canister 189, 190, 191, 196
Installing 158 Cardiac Bypass 134
Airway Pressure 132 Cautions 152
Airway Pressure Limiting [APL] valve CE Marking 211
186 Center Seal 191
Alarm Messages 179 Certificate of Compliance 4
Alarm Mute 145 C.G.O. Pressure Relief Valve 61
Alarms 35, 86, 134 C.G.O. Safety Valve Check 78
Alarms Display Area 101 Change a Disposable Canister 198
Alarm Setup 106 Change Names 148
Alarm Setup Menu Tree 106 Changing/Entering New Password
Alarms Setup Menu 144 149
Alarms Summary 136 Cleaning 55, 82
Amsorb 190 Cleaning and Sterilization 162
Ancillary Equipment 55 CO2 Bypass 187
Anesthetic Machine Common Gas Outlet 33
Maneuvering 74 Comms Fail 137

BleaseSirius User Manual 251


Index

Compliance 159 Event Message 177


Condensate 196 Examples of Loops 130
Configuration 150 Exchanging Non-return Valve Discs
Controls 34, 68 202
Control Unit 161 Extended Work surface 50
Copyright 211 External Communication
Current Loop 129 Specification 173
Cylinder 76
Cylinders 40 F
Installing 40 Factory Default Settings 169
D Fan Fail 140
Features 55
Da-lites 73 Fill the Inner Canister 189
Data Transmission Settings 173 Filter 52
Defaults Menu 106, 146 Fixed Features 170
Defaults Menu Tree 106 Flowblock Assemblies 76
Description 27, 186 Flowmeter Backlight 73
Dimensions 206 Flow/Volume 130
Discharged Battery 156 Frame 31
Disclaimer 210 Fresh Gas 116, 159
Disposable Canisters 190 Fresh Gas Too High 139
Drawers 73 Front Of Machine 28
Dual Mode Ventilation 86 Front Panel 99
Full System Test 79
E
G
Electrical 35
Electrical Cable Color Specifications Gas-Specific Color Specifications 33
33 General Test 78
Electronic Flowmeter (EFM) 23, 29,
38, 69, 73, 76 H
EMC Tests for IEC 60601-1-2 Compli- Hazard Notices 213
ance 246 High BPM Alarm 141
Environmental 36 Home Key 100
Error Codes 181 Hypoxic Guard 71
ESD 26

252 BleaseSirius User Manual


Index

I N
Identify your Ventilator 84 Nitrous Oxide System 66
I:E Ratio 97 Non-return Valve Discs 202
I:E Setting 119 Normal Screen 100
Indicators 35 Note to Service Personnel 210
inspiratory and expiratory valve discs
194 O
Inspiratory Pause 91 O2 Calibration with A.C.G.O. System
Installation 40, 152, 205 121
Introduction 25 O2 Sensor Error 137
K O2 Supply Fail 139
On/Off Switch 80
Key Fill Vaporizer 39 Operating Modes 88
Operation 58
L Optional Features 37, 38
Leak Test 79 Other Maintenance 161
Low Battery Indicator 87 Outer Canister 191, 192, 198, 199,
Low BPM Alarm 142 202
Low Oxygen Alarm 141 Overview 85
Low Supply Gas Pressure Alarm 137 Oxygen Calibration 120
Oxygen Failure Warning Device 64
M Oxygen Failure Warning System
Check 76
Machine Dimensions 32 Oxygen Flush 71
Maintenance 196 Oxygen Flush Tap Test 81
Manometer 205 Oxygen Probe 44
Maximum Loading 32 Handling 45
Measured Value Messages 175 Oxygen Sensor 205
Measurements Menu 122 oxygen Sensor Port 194
Mechanical Hypoxic Guard Test 81 Oxygen System 64
Medical Air System 67 Oxygen Transducer 43
Menu Tree 105 Connecting 43
Methods of Sterilization 165
Miscellaneous 33
Mode Dependant Features 171
Monitor Shelf 31
Monitor Shelf Dimensions 32
MV High Alarm 142
MV Low Alarm 142

BleaseSirius User Manual 253


Index

P Pressure Support Defaults 170


Pre-Use Check 75, 154, 194
Parameter Display Area 101 Pre-use Test 159
Parameters 95 Pre-use Test Error Messages 113
Patient Airway Flow Sensor 51 Pre-use Testing 108
Patient Airway Flow Sensor Principles of Operation 93, 187
and Tubing 162 Product Improvement 209
Pause 133 Protocol 173
Pause + Sigh settings 134
PAW <-10 cmH2O 139, 146 R
Deselecting 146
Selecting 146 Recalling loops 129
Pediatric mode 123 Recall Previous Settings 149
Pediatric Flow Sensor 124 Regulator Safety Valve Settings 35
PEEP 95 Removal 205
PEEP Alarm 140 Replace the Reusable Canister Soda
Performance 206 Lime 196, 197
Performance Data 168 Responsibilities of the Manufacturer
Physical 32 209
Pin Connections 174 Responsibilities of the User 209
Pipeline 76 Reusable Canister 189, 191
Pneumatic Assembly 31 Routine Maintenance Checks 202
Pneumatic Circuit 62, 69 Routine User Maintenance 161
Pneumatics 33
Pneumatic System 94
S
Pneumothorax during Laparoscopy Save Current Settings 149
131 Save Hospital Defaults 147
Pop-off Valve Seat 164 Saving and Recalling Settings 147
Post-Installation Check 58 Scavenging 187
Power Fail and Battery Low Alarms Selectatec Mounting 39
139 Sensitive 26
Precision Pressure Control 89 Sensor Error 140
Pre-set Alarms 137 Sensor Not Detected 140
Pressure Control Ventilation Defaults Sensor Placement 125
169 Sensor Tubing 162
Pressure High Alarm 138 Service Kit 203
Pressure Limit 97 Set Messages 174
Pressure Low Alarm 142 Setting Alarms 144

254 BleaseSirius User Manual


Index

Setting Error Alarm 140 T


Setting Parameters 134
Setting the Alarm Mute Time 145 Tamper Proof Seal 210
Setting the Apnea Time 145 Technical/Performance Specifications
Setup Menu 105 34
Sigh 91 Technology Disclaimer 210
SIMV Interlock 90 Testing 55
SIMV-PC + PSV 90 Touch Screen 102
SIMV-VC + PSV 90 Setting Parameters 103
Six-Monthly Checks 161 Change Settings 103
Soda Lime 197 Trademarks and Acknowledgements
Soda Lime Canister 189 212
Replenishing 189 Trak Wheel 102
Usage 197 Editing a Parameter 102
Soda Lime Storage 200 Selecting a Menu Item 103
Spare Parts 204 Selecting a Parameter 102
Specification 32 User adjustable parameters 103, 104
Spirometry 87, 128 Trigger 96
Spontaneous Breathing 187 Troubleshooting 166
Spontaneous Breathing Setup 195 Tubing 193
Standby 117
U
Sterilization 201
Suction Controller 54 Under Pressure Alarm (PCV mode
Fitting 54 only) 141
Sustained Pressure Alarm 138 User Defined Alarms 141
Symbols 22 User Interface 99
System Check 111 User Maintenance 75
System Information 150

BleaseSirius User Manual 255


Index

V
Vaporizers 39, 72
Fitting 45
Ventilator 34
Activating and monitoring alarms
108
Description 85
End of Case 108
Features 86
Powering Down 108
Powering Up 107
Starting 107
Stopping 108
Using 107
Ventilators 58
Ventilator Surfaces 162
Ventilator Test 82
Vent Inoperative Alarm 138
Volume Control 89
Volume Control Defaults 169

W
Warning System Checks 80
Waveform Select Menu 128
Weekly Checks 161
When to Replace the Soda Lime 197
Work Surface Dimensions 32

256 BleaseSirius User Manual


Index

BleaseSirius User Manual 257


258 BleaseSirius User Manual