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Enterprise

User Manual
Version 1.5 (EN)
Copyright notice
Copyright © 2012 Fysicon B.V. and/or one of its subsidiaries.
All Rights Reserved.
Use of this documentation and related software is governed by a license agreement. This
documentation and related software contain confidential, proprietary and trade secret information
of Fysicon and are protected under Dutch and international copyright and other intellectual property
laws. Use, disclosure, reproduction, modification, distribution, or storage in a retrieval system in any
form or by any means is prohibited without the prior express written permission of Fysicon. This
documentation and related software are subject to change without notice.

Publication date
December 2012

Product and version


QynetiQ™Enterprise Version 1.6

Corporate addresses

Fysicon BV
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands
Tel: +31 412 653333
Fax: +31 412 653330
email: info@fysicon.com

0044
Fysicon BV
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands

2 QynetiQ™ Enterprise – User Manual (Version 1.5)


Reader comments
Any comments or suggestions regarding this publication are welcomed and should be forwarded to
Fysicon BV
att. Quality Management
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands

QynetiQ™ Enterprise – User Manual (Version 1.5) 3


Table of Contents
1. General information about QynetiQ™ patient care monitors ................................................... 10
1.1 Intended use of patient care monitors ....................................................................................... 10

1.2 QynetiQ™ Product line ................................................................................................................ 11

2. QynetiQ™Enterprise ............................................................................................................... 12
2.1 Display of “Live” signals ............................................................................................................... 13

2.2 Parameter modules ..................................................................................................................... 14

2.3 Power Unit and connection parts ............................................................................................... 15

2.4 Front-end Connections ................................................................................................................ 16

2.5 Data presentation on the monitor’s screen ................................................................................ 17

3. Operating the system ............................................................................................................. 20


3.1 Power-on and Log-In ................................................................................................................... 20

3.2 Safety of monitor’s usage ............................................................................................................ 20

3.3 General information concerning safety usage of the monitor.................................................... 21

3.4 Warnings and cautions concerning operation of monitors ........................................................ 21

3.5 Manufacturer’s responsibility ..................................................................................................... 22

3.6 User’s responsibility .................................................................................................................... 22

3.7 Required power supply conditions.............................................................................................. 23

3.8 Monitor’s labeling ....................................................................................................................... 24

4. Setting up the System ............................................................................................................. 26


4.1 Setting the monitor’s work parameters ...................................................................................... 26

4.2 Basic rules of appropriate patient monitoring ............................................................................ 27

5. Creating patients and procedures............................................................................................ 29


5.1 Creating a new patient ................................................................................................................ 29

5.2 Opening an existing patient and create a new procedure .......................................................... 30

5.3 Opening an existing patient and an existing procedure ............................................................. 31

5.4 Monitoring the patient ................................................................................................................ 32

6. Procedure Control .................................................................................................................. 33


6.1 ECG Module ................................................................................................................................. 34

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6.1.1 Module description .............................................................................................................. 34

6.1.2 Using the ECG module .......................................................................................................... 34

6.1.3 ECG module settings ............................................................................................................ 35

6.1.4 ECG module messages.......................................................................................................... 37

6.1.5 Maintenance and cleaning ................................................................................................... 37

6.1.6. Accessories and ordering information ................................................................................ 37

6.2 Arrhythmia analysis ..................................................................................................................... 38

6.2.1 Module description .............................................................................................................. 38

6.2.2 Arrhythmia module alerts .................................................................................................... 39

6.2.3 Maintenance and cleaning ................................................................................................... 40

6.2.4 Accessories and ordering information ................................................................................. 40

6.3 IBP Module .................................................................................................................................. 40

6.3.1 Module description .............................................................................................................. 40

6.3.2 Using IBP module ................................................................................................................. 40

6.3.2.1 Step 1 – filling IBP sensor with saline ............................................................................ 41


6.3.2.2 Step 2 – filling IBP sample line with saline .................................................................... 42
6.3.2.3 Step 3 – preparing the IBP sensor for measurement .................................................... 42
6.3.3 IBP module settings .............................................................................................................. 43

6.3.4 IBP module messages ........................................................................................................... 45

6.3.5 Maintenance and cleaning ................................................................................................... 45

6.3.6 Accessories and ordering information ................................................................................. 45

6.4 Condition settings........................................................................................................................ 46

6.5 Presets ......................................................................................................................................... 46

6.6 Timers .......................................................................................................................................... 47

6.7 Alerts ........................................................................................................................................... 47

6.8 Respiration .................................................................................................................................. 49

6.8.1 Module description .............................................................................................................. 49

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6.8.2 Using respiration module ..................................................................................................... 49

6.8.3 Respiration module settings................................................................................................. 49

6.8.4 Respiration module messages .............................................................................................. 50

6.8.5 Maintenance and cleaning ................................................................................................... 50

6.8.6 Accessories and ordering information ................................................................................. 50

6.9 Pulse Oximetry module – SpO2 ................................................................................................... 51

6.9.1 Module description .............................................................................................................. 51

6.9.2 Using the SpO2 module......................................................................................................... 51

6.9.3 SpO2 module settings ........................................................................................................... 53

6.9.4 SpO2 module messages ........................................................................................................ 54

6.9.5 Maintenance and cleaning ................................................................................................... 54

6.9.5.1 Reusable finger sensor and extension cable ................................................................. 54


6.9.5.2 Reusable “Y” sensor ...................................................................................................... 55
6.9.5.3 Ear clip for the reusable “Y” sensor............................................................................... 55
6.9.5.4 Adhesive tapes .............................................................................................................. 56
6.9.6 Accessories and ordering information ................................................................................. 56

6.10 Temperature module ................................................................................................................ 57

6.10.1 Module description ............................................................................................................ 57

6.10.2 Using the temperature module .......................................................................................... 57

6.10.2.1 Types of temperature probes – Skin Probes ............................................................... 57


6.10.2.2 Types of temperature probes - Central probes........................................................... 58
6.10.3 Temperature module settings ............................................................................................ 59

6.10.4 Temperature module messages ......................................................................................... 59

6.10.5 Maintenance and cleaning ................................................................................................. 60

6.10.6 Accessories and ordering information ............................................................................... 60

6.11 Non-invasive blood pressure module – NIBP ............................................................................ 61

6.11.1 Module description ............................................................................................................ 61

6.11.2 Using the NIBP module....................................................................................................... 61

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6.11.2.1 “On demand” measurement ....................................................................................... 62
6.11.3 NIBP module settings ......................................................................................................... 63

6.11.4 NIBP module messages ...................................................................................................... 63

6.11.5 Maintenance and cleaning ................................................................................................. 64

6.11.6 Accessories and ordering information ............................................................................... 65

6.12 Cardiac Output module – CO..................................................................................................... 65

6.12.1 Module description ............................................................................................................ 65

6.12.2 Using the Cardiac Output module – CO ............................................................................. 67

6.12.2.1 Preparation for Cardiac Output measurement ........................................................... 67


6.12.2.2 Cardiac output measurement ..................................................................................... 68
6.12.2.3 The Computation Constant (CC).................................................................................. 70
6.12.3 CO module messages ......................................................................................................... 70

6.12.4 CO module alarms .............................................................................................................. 71

6.12.5 Cleaning and disinfecting accessories ................................................................................ 71

6.12.5.1 CO cable and reference probe .................................................................................... 71


6.12.5.2 Disposing Swan-Ganz catheters: ................................................................................. 71
6.12.6 Accessories and ordering information ............................................................................... 72

6.13 Vitals .......................................................................................................................................... 73

6.14 Samples ..................................................................................................................................... 74

6.15 ST analysis.................................................................................................................................. 88

6.15.1 Module description ............................................................................................................ 88

6.15.2 Using ST analysis................................................................................................................. 88

6.15.3 ST analysis module settings ................................................................................................ 89

6.15.4 ST analysis module messages ............................................................................................. 89

6.15.5 Maintenance and cleaning ................................................................................................. 90

6.15.6 Accessories and ordering information ............................................................................... 90

6.16 FFR ............................................................................................................................................. 90

6.16.1 Module description ............................................................................................................ 90

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6.16.2 Using the FFR module......................................................................................................... 90

6.16.2.1 Preparing the module.................................................................................................. 90


6.16.2.2 Manual FFR measurement .......................................................................................... 91
6.16.2.3 Automatic FFR measurement ...................................................................................... 92
6.16.2.4 QynetiQ™ Toolbar ....................................................................................................... 92
6.16.2.5 FFR through the full disclosure.................................................................................... 92
6.16.3 Reviewing FFR results ......................................................................................................... 93

6.17 Generating a report ................................................................................................................... 93

7. Sample review ........................................................................................................................ 94


7.1 Viewing the samples you created ............................................................................................... 95

7.1.1 Open a sample ...................................................................................................................... 95

7.1.2Opening the settings menu ................................................................................................... 95

7.1.2.1 ECG settings ................................................................................................................... 97


7.1.2.2 IBP settings .................................................................................................................... 98
7.1.2.3 SpO2 and respiration settings ....................................................................................... 98
7.1.2.4 Other settings ................................................................................................................ 99
7.1.2.5 Toolbox .......................................................................................................................... 99
8. Full disclosure........................................................................................................................101
8.1 Full disclosure settings menu .................................................................................................... 101

8.1.2 Making samples from the full disclosure ........................................................................... 102

9. Alarms...................................................................................................................................104
9.1 ALARM PRIORITY TABLE part 1 .................................................................................................. 105

9.2ALARM PRIORITY TABLE part 2................................................................................................... 106

9.3 Medical alarms .......................................................................................................................... 107

9.4 Medical alarms – setting the alert limits ................................................................................... 107

9.5 Technical alarms ........................................................................................................................ 110

9.6 Alarm status .............................................................................................................................. 111

10. Keyboard shortcuts ..............................................................................................................112


11. Monitor shutdown...............................................................................................................113
12. Cleaning and maintenance ...................................................................................................114
13. Recycling information, WEEE ................................................................................................115

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14. Technical information ..........................................................................................................116
14.1 QynetiQ™Enterprise ................................................................................................................ 116

14.2 12 Lead ECG Module ............................................................................................................... 116

14.3 7 Lead ECG Module ................................................................................................................. 117

14.4 NIBP Module............................................................................................................................ 118

14.5 SpO2 Module............................................................................................................................ 118

14.6 IBP Module .............................................................................................................................. 118

14.7 Temperature Module .............................................................................................................. 118

14.8 Cardiac Output (CO) Module ................................................................................................... 119

14.9 CO2 Module ............................................................................................................................. 119

15. Authorized service ...............................................................................................................120


16. Reader Comment Form ........................................................................................................121
17. Contact information.............................................................................................................122

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1. General information about QynetiQ™ patient care monitors
This chapter is an introduction to the usage of the QynetiQ™ patient care & haemodynamic monitors
and includes information concerning:

 housing of the monitors and sockets available for the user to connect probes, cables and to
control the monitors,
 way of controlling basic parts of monitors,
 information about safe monitors usage,
 installation and preparation monitors to work,
 essential actions of monitors’ operation,
 general rules of monitors’ maintenance.

1.1 Intended use of patient care monitors


The monitors of the QynetiQ™ product line enable monitoring and supervision of:

 patient’s physiological parameters, important for the patient’s life and a treatment process,
 characteristic parameters of the patient’s treatment process, important for the process
controlling.

The monitors of the QynetiQ™ product line include stationary and remote monitors, used as bedside
monitors.

The QynetiQ™Advanced and the QynetiQ™Care monitor are intended to be used inside buildings in
care units at the patient bedside, a diagnostic stand or in a catheterization room. The QynetiQ™
Enterprise is intended to be used in a cardiac catheterization room, as it incorporates also extensive
reporting tools. The QynetiQ™ Enterprise system can be integrated with FlexPAXS®, this
configuration is called; The QynetiQ™ Cardio Vascular Information System.

The QynetiQ™ Monitors are modular. A type and number of monitored parameters may be
configured according to user’s requirements. A list of available monitoring modules includes:

 electrocardiogram – from limb and pre-cordial leads with possibility of ECG analysis,
 respiration – using reographic method,
 blood pressure – using invasive method,
 arterial blood pressure – using non-invasive method,
 oximetry – using photometric method,
 carbon dioxide concentration –inspired and expired air using mainstream and side stream
method,
 temperature – monitored in chosen points of patient’s body with a possibility of measuring a
difference between temperatures,
 cardiac output – using the thermo dilution method.

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The monitors of the QynetiQ™ product line are intended to perform patient monitoring in various
medical conditions:

 in ICU, also specialist e.g. cardiologic and pediatric wards,


 in pre- and post-operation wards,
 in operating rooms,
 in (cardiac) catheterization labs,
 in neonatal wards,
 in emergency wards.

The monitors assure during supervision of patient vital signs:


 alarm signaling in case of threatening situations, when alarm limits of monitored parameters
have been exceeded or in situations of technical problems with monitors,
 storage and archiving of monitored parameters’ values and their trends presentation,
 network data transfer,
 printouts of stored waveforms and information,
 storage and archiving the patients’ data.

The QynetiQ™ product line is a state-of-the-art solution for your monitoring requirements.

1.2 QynetiQ™ Product line


The QynetiQ™ product line includes state-of-the-art monitoring devices, which allow both a flexible
and complex usage at individual diagnostic stands but also organizing patient supervision network in
ICUs, recovery areas, operating rooms, catheter labs, etc.

This product line consists of stationary monitors, which may work with various parameters
configurations, what allows patient monitoring during complex procedures and at the hospital ward.

The QynetiQ™ product line includes the following devices:

 QynetiQ™ Care

 QynetiQ™ Advanced

 QynetiQ™ Advanced+

 QynetiQ™ Enterprise

Thanks to the newest construction and the technology, the QynetiQ™ product line has a compact
and light structure, which allows an easy installation at a hospital bedside, a diagnostic stand, an
operating table or in a cardiac catheter lab. The housing of all monitors is made of materials, which
ensure safety during their usage and easy to maintain and to clean.

The QynetiQ™ Enterprise system can be integrated with FlexPAXS®, this configuration is called; The
QynetiQ™ Cardio Vascular Information System.

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2. QynetiQ™Enterprise
The QynetiQ™Enterprise system is a modularfront-endwith a separated isolated power supply. The
Front-end can be mounted app. 25 meters from the Power-Unit and app. 25 meters from the
Touchscreen, which is used to operate the system.(Fig.2.01).

Fig. 2.01

A QynetiQ™Enterprise System consists of three parts:

 The Display’s – High resolution LCD TFT screens, which are able to present waveforms,
digital values of all measured parameters, reports, etc.
 The Front-end – This Front-end has a universal cavity with a special shape, which facilitates
placing up to 7 parametermodules in the right position. The modules can be easily removed
from the monitor by the user and placed in one of the other modular monitors of the
QynetiQ™ product line. The modules are automatically identified by the monitor’s software
and the monitor automatically configures itself for work with a newly inserted module.
 A Power Unit – The Power Unit is situated in the machine room of a catheter lab, and is the
power source of the Front-end and the monitor(s). It incorporates an Isolated Power supply.

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All cabling is redirected to the Power Unit in the machine room. The touch screen is mounted in the
monitor boom of the X-ray system or on a wall-mount in the catheter lab.

CAUTION!
To remove any of the modules; Press the button, located at the bottom of every module (Fig. 2.02),
and gently pull the module towards yourself in order to remove the module from the
QynetiQ™Front-end’s cavity.Gently insert the module into the QynetiQ™Front-end’s cavity and
press the module, so it is connected to a socket placed on the back wall of the cavity, in order to
start the module to work.

Module release button Blocking column

Communication and
power connector

Parameter socket

Fig. 2.02

2.1 Display of “Live” signals


Thanks to color displays, the QynetiQ™Enterprisesystem is able to present information about
monitored patients in a clear and easy way to understand. The information is presented as waveform
as well as numerical in the control room as well as in the lab.

It is possible to display up to 18 waveforms together with digital values. Two examples are shown on
the next page; 12 Lead ECG together with the numerical values of IBP, SpO2 and NiBP (figure 2.03),
and a standard setup in a cardiac catheterization lab; 3 Lead ECG with 2 IBP Channels, SpO2 and
Respiration and of course the numerical with digital values of other parameters (sample figure 2.04).

QynetiQ™ Enterprise – User Manual (Version 1.5) 13


Fig. 2.03 Fig. 2.04

The QynetiQ™Enterprise system is standard equipped with 19” color LCD TFTscreens, which is
prepared for safe usage by a special insulation of the power supply.

CAUTION:
Only a special bracket delivered by the manufacturer may be used for the installation of the Front-
end on tableside.
The displays of the QynetiQ™Enterprise system must be powered only from the Power Unit. It is
not allowed to supply the power to the display of the stationary monitors from a different source.

2.2 Parameter modules

CAUTION:
It is up to the end-used which parameters modules will be installed. This must be defined before
the monitor is ordered. Additional modules can be re-ordered at any time.

The QynetiQ™Enterprise system has easy to remove, independent parameter modules in the shape
of rectangular cubes. Every module is placed in a separate plastic housing, which may be moved to
another QynetiQ™ monitor. An input socket for connecting the sensors and cables is placed on the
front panel of every measuring module.

The following parameter modules are currently available:


 ECG and respiration module - ECG/RESP
 non-invasive blood pressure module - NIBP
 puls oximetry module - SpO2
 invasive blood pressure module - IBP1, IBP2, IBP3 en IBP4
 temperature module - T1, T2
 carbon dioxide module - CO2
 cardiac output module - CO
 thermal printer module - Recorder

14 QynetiQ™ Enterprise – User Manual (Version 1.5)


The Front-end of a QynetiQ™Enterprise, with a sample set of parameter modulesis presented in
figure 2.05.

Fig. 2.05

WARNING!
The modules may be freely installed depending on the user’s requirements. Except of the ECG
module which needs to be installed in the first slot.
The system accepts up to 2 IBP modules, with a maximum of 4 IBP channels.

2.3 Power Unit and connection parts


The QynetiQ™Enterprise system is powered from the QynetiQ™ Power Unit. The green led situated
in the lower right corner of the monitor’s front panel is lighted, when the monitor is connected to the
mains and the main power supply switch is switched on (Figure 2.06).

Fig. 2.06

The following connections are situated on the back panel of the QynetiQ™Power Unit (Fig. 2.07):

 mains power supply cord socket (230V, 50 Hz),


 isolated power supply outlets (230V, 50 Hz),
 on/off switch,
 power supply outlet for QynetiQ™ Front-end (20V),
 potential grounding (earth reference),
 label Power Unit

QynetiQ™ Enterprise – User Manual (Version 1.5) 15


4

2
3
1 5

1. Hospital Mains input, 230V 4. On/Off switch


2. Power outlet, 230V 5 x 5. Power outlet to Front-End, 20V
3. Earth reference point

Fig.207

2.4 Front-end Connections


The Front-end of the QynetiQ™ Enterprise has Isolated Outputs for ECG and Trigger signal. The
parameter modules are as mentioned before exchangeable with the modules from the QynteiQ™
Advanced and Care monitors. The following connections are situated on the back panel of the
QynetiQ™Front-end (Fig. 2.08):

1. Power button 10. PS2 Connection (Not used)


2. Fuse 11. Video out live data
3. Power connector (20V) 12. Analog ECG out
4. Video in for VGA extender 13. Analog ECG out
5. UTP VGA extender out to USB hub (control room) 14. ECG Trigger out
6. UTP VGA extender to Live monitor in the Monitor 15. ECG Trigger out
Suspension of the X-Ray system 16. Calibration switch touchscreen
7. USB (for Firmware upgrades) 17. Reset switch (not used)
8. RS232 for Touchscreen(Not used) 18. Earth point
9. UTP LAN for Network connection to CPU 19. UTP LAN (not used)

Fig. 208

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power supply cord socket (20V) – to be powered by the Power Unit,
 UTP VGA extender connections
 VGA cable sockets for Back-up loop of the Life signals,
 Analog ECG signal and Triggeroutputs (isolated)
 touch screen socket, Ethernet network,
 potential grounding (earth reference),
 monitor label.
 Touch screen calibration button
 CPU reset button
 USB connection (For service purposes Only!)

WARNING!
A short main power failure may turn the monitor off and when the main power is present again,
the QynetiQ™Enterprise application will starts up again and after a few second the vital signs will
be monitored again (screen setup is a default configuration).It is highly recommended to use an
UPS (uninterruptible Power Supply), in case of often, short power failures.
The PC-unit which takes care of reporting calculations and the storage of samples will be up and
running within a couple of minutes.

2.5 Data presentation on the monitor’s screen


All information presented by the QynetiQ™Enterprise system, which concerns the patient’s
parameters, operating, maintenance messages, will be displayed on the color screen of the monitor.

A sample screen of the monitor is shown at figure 2.09.

Fig. 2.09

The monitor presents the information in several ways;


 dynamic waveforms:
 curves of the monitored parameters,
 trends of the monitored parameters.
 digital values:
 temporary or average values of the monitored parameters,

QynetiQ™ Enterprise – User Manual (Version 1.5) 17


 values of alerts limits concerning the monitored parameters,
 values of inserted and derived patient’s biological parameters.
 graphical items:
 windows concerning measuring modules,
 windows signaling special states of monitoring e.g. alerts.
 text messages:
 messages concerning characteristic features of the patient’s biological parameters,
 messages concerning a monitoring process,
 messages concerning a state of the monitor work and its accessories.

Information presented on the monitor display is divided into three groups:


 Information identifying patient monitoring process:
 patient data,
 data, which identify a monitoring process: date and time.
 Information concerning the maintenance of the monitor:
 menus,
 information concerning a way of presenting the waveforms on the screen,
 messages concerning monitoring process.
 Information gathered, presented and controlled during patient monitoring process:
 dynamic waveforms of monitored patient vital signs,
 trend graphs of changes in time of the monitored signals,
 digital values of characteristic features of monitored parameters,
 digital values of derived and analyzed monitored signals,
 digital values of alarms used for supervision of monitored parameters.

The screen is divided into three areas:


 Upper toolbar (Fig. 2.10)where the following function fields are placed:
 patient name, ID and date of Birth;
 the alarm mode;
 alarms and maintenance messages or the information about all alarms disabling;
 time.

Fig. 2.10

 The central area (Fig. 2.11) is intended to presentation of waveforms and digital values of
monitored parameters. Including:
 dynamic waveforms presented in a form of graphical curves displayed from the left to the
right side of the screen,
 measuring modules windows present digital values of specific parameters of the monitored
patient’s biological parameters,

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 sample window to present all measured samples (incl. Cardiac Output). This window will
disappear when CO is measured, as the CO window will be situated at the sample window.

Fig. 2.11

 Lower toolbar,
- waveform sweep speed;
- comment bar

WARNING!
Visual information is presented also outside the monitor’s display in a form of LED indicators,
which shows states of monitor’s work.
 “~” green light indicator – informs about connecting the monitor to the mains.
 “I” green light indicator– informs about switching the monitor on (the screen should start
displaying the first screen after about 20 seconds after the lamp starts to shine).

QynetiQ™ Enterprise – User Manual (Version 1.5) 19


3. Operating the system
3.1 Power-on and Log-In
To power-up the QynetiQ™ Enterprise it is necessary to switch the Power Unit on first, as this will
provide the mains to the PC-Unit, and secondly the PC-Unit.

The Vital signs monitoring will start almost immediately and the PC Unit is ready when it prompt to
fill in the Username and Password (fig. 3.1).

Fig. 3.1

After three attempts, the account will be blocked and you need to contact the system administrator.

3.2 Safety of monitor’s usage


The monitors manufactured by Fysicon are intended to operate constantly if conditions of a proper
maintenance and technical control suggestions are fulfilled. The manufacturer or authorized service
partner checks the monitors and it functions at least once per year.

A precise technical control and the exchange of parts that concern the safety of monitor and/or it
usage must be made, if the monitors are used longer than 10 years.

This chapter includes general information crucial for the safety usage of QynetiQ™Enterprise
monitors.

Additionally, notices, special symbols placed at the housing of the monitor and warnings important
for safe usage and operation of the monitor are described in this chapter.

20 QynetiQ™ Enterprise – User Manual (Version 1.5)


3.3 General information concerning safety usage of the monitor

CAUTION:
Disposable parts must not be used twice and should be disposed according to the local regulations.
Only accessories manufactured or recommended by Fysicon must be used in order to ensure
patient’s safety.
The monitor is a device, which may be used only for monitoring of one patient at the time.

WARNING!
The user responsible for monitor’s maintenance should perform a procedure, which checks
the correctness of the monitor’s functionality by checking the messages and statuses displayed on
the screen, once per week. The monitor’s equipment, extension cables, leadwires and probes
should be also inspected.
It is necessary to perform a temporary manufacturer’s check-up of all important monitor’s
functions at least once per year or more frequently, whenever functionality of the monitor is
questionable.

WARNING!
The user must inform manufacturer or manufacturer’s representative in case of any medical
incident:
Manufacturer: Fysicon
Hoogheuvelstraat 114,
5349 BA Oss, the Netherlands
phone: +31 412 65 33 33
fax: +31 412 65 33 30
e-mail: support@fysicon.com

3.4 Warnings and cautions concerning operation of monitors

 Familiarize with the safety recommendations concerning the power supply and safety of
usage of other devices, in case of connecting them to the QynetiQEnterprise monitor, to
ensure safety of the monitors’ functionality.
 Place the cables in a distance from the patient’s neck to prevent patient’s strangulation.
 Make sure that the conductor parts of the electrodes and other conductors do not touch
other conductors including grounding connection.
 The monitor must be immediately disconnected from the patient and the mains in case of
pouring a liquid on the monitor. The person responsible for monitor’s maintenance must
check if the monitor did not become damaged before it is turned on again.
 The user must pay special attention to using monitor in the presence of flammable
anesthetic gases.
 Special attention for safety of a patient should be paid during defibrillation. The monitor is
technically protected against the defibrillator impulse. A defibrillator is a serious danger for
QynetiQ™ Enterprise – User Manual (Version 1.5) 21
the patient as well as the user because of the high voltage (up to 5 kV) needed for the
defibrillation. The defibrillator paddles should not be placed on top of ECG electrodes and/or
leadwires.
 The monitor is protected against defibrillator shocks and high frequency disturbances.
 Only cables recommended by Fysicon must be used in order to ensure safety during the
defibrillation.
 Do not touch the monitor during the defibrillation, because it may cause a serious injury.
 The monitor is protected against pacemakers and ICD’s.
 The monitor’s housing must not be opened. The monitor must not be repaired by the user in
case of its improper work, because the user may be exposed to an electrical shock.
 It is not necessary to shut down the monitor during a position change of a parameter module
of the QynetiQEnterprise system or moving a module to or from another QynetiQ Care,
Advanced or Enterprise monitor. The monitor is protected against unstable states caused by
inserting and removing the modules from the monitor.
 In case of falling down or applying a mechanical shock to the monitor, it is necessary to
perform safety and functionality tests. The tests should be done by a manufacturer’s service
representative
 The improper room ventilation, where the monitor works, may cause the monitor’s failure
and make the monitoring difficult. Do not place any objects at the monitor, which would
cause worsening of the heat exchange.

CAUTION:
The manufacturer is not responsible for any damage of the monitor caused by improper room
ventilation, improper or a damaged power supply and or a faulty installation performed by any
other than the manufacturer or its local representative.

3.5 Manufacturer’s responsibility


The manufacturer is responsible for safety and the reliability of the monitor when:

 Installation, check-ups, modification, upgrading or repairs of the monitor are performed by


Fysicon’s specialists,
 Electrical installation fulfills the requirements concerning safety class I and grounding
connection is properly connected to a central grounding system,
 The monitor is used according to its intended use and the user’s manual.

3.6 User’s responsibility

 The monitor must be used by qualified and trained medical personnel only,

22 QynetiQ™ Enterprise – User Manual (Version 1.5)


 The user takes responsibility for the compliance to this user’s manual instructions,
 Proper hygienic conditions must be ensured for the service-engineers, in case of servicing the
monitorat the user’s premises,
 The monitor and the accessories must be decontaminated in case they need to be send in for
repair, in order not to threat the forwarder and the service engineer’s health,
 The monitor must be packed in the original box when it is sent in for service; this box will
protect the monitor during transportation. Warranty claims will not be granted when the
monitor arrives, without proper packaging.

3.7 Required power supply conditions

WARNING!
The institution is responsible for the technical condition/installation of the 230 VAC mains circuit.
It is necessary to submit a statement, which concerns compliance of the mains circuit with Class I of
safety regulations, before the installation of the monitor.
The power circuit, which the monitor is connected to, should be checked at least once a year and a
proper written document as prove should be included into the building documentation.

 The monitor must be powered from 230 VAC  10%.


 The monitor may be installed in medical rooms equipped with a separated power network
with over-current protection. However the neutral wire and the grounding wire must be
separated.
 Protection grounding must be made either separately or commonly with grounding of the
neutral wire in the transformer, which powers the building. The protection grounding of
the medical room must be connected in electrically reliable, mechanically durable and
resistant to corrosion way with the protection grounding electrode.
 The monitor may be installed in medical rooms intended for intensive supervision, where a
temperatureis within a range of 10 - 40°C and humidity is not higher than 80%.
 The air in a room, where the monitor is installed, should be free of toxic gasses, vapor and
dust. Concentrationof flammable gasses should not exceed values, which could cause an
explosion, because the monitor is nota spark-safe device.
 Do not install any containers with liquid in a close distance (over, under or near) the monitor
to avoida possibility of accidental pouring liquid at, on or inside the monitor.

QynetiQ™ Enterprise – User Manual (Version 1.5) 23


3.8 Monitor’s labeling

The user’s manual must be read, before operating the monitor.

CF class device, defibrillator impulse protected. Devices of this class


are intended to using with applications, which have a direct wire
connectionto patient’s heart.

BF class device, defibrillator impulse protected. Device of BF class


is intended to using for outside or inside patient’s body except a
direct wire connection to patient’s heart. BF class means, that the
device has isolated components (F).

Caution, dangerous voltage.

BF class device. Device of BF class is intended to using outside or


inside patient’s body except a direct wire connection to patient’s
heart. BF class means, that the device has isolated components (F).

Monitor’s label (example Front-end)

Max. 50W Label concerning a maximum power consumption of the device


connected to a socket marked with this label.

Screen blanking button.


WYG.
Optional button, used for service purposes only.

Simulation screen button.


SYM.
Optional button, used for service purposes only.

24 QynetiQ™ Enterprise – User Manual (Version 1.5)


Touch screen calibration button.
KAL.
Button may be used by a user in case of touch screen operation
problems for touch screen calibration.

~ If the green lamp shines over this informs that the QynetiQ™Power
Unit monitor is connected to Mains (230VAC)

I If the green LED is lighted, theQynetiQ™Enterprise monitor is


working.

QynetiQ™ Enterprise – User Manual (Version 1.5) 25


4. Setting up the System

 The system must be installed and fixed securely by using the provide brackets in a secure and
reliable way. The provided wall-bracket protects the system from accidentally falling down.
 Connection to a 3-wired 230 VAC power network should be made under supervision of the
qualified personnel.

CAUTION!
Plug the power supply cord of the Power Unit into the 230 VAC wall socket (with protection of a
grounding connection) and switch the power on using the switch placed at the back of the
QynetiQ™Front-end, the PC-Unit and on the Power Unit (Fig. 2.07 en Fig. 2.08).

 Turn on the monitor with an on/off switch (Fig.2.08). The Live- screen should start displaying
after around a couple of second after switching the monitor on.
 Plug the cables and probes into the monitor’s sockets.
 Check the functional correctness of every measuring circuit and read the messages displayed on
the monitor screen.

4.1 Setting the monitor’s work parameters


Patient monitoring should be started by connecting all necessary at the moment cables and probes
to a patient. It is possible to connect the following items to the fully equipped monitor:
 10 Lead, 3 Lead or 5 Lead ECG cable,
 Non-invasive blood pressure cuff of an appropriate size,
 Finger or “Y” SpO2 probe,
 CO2 probe or a sampling line for a CO2 module,
 Central or skin temperature probe,
 Invasive blood pressure sensor together with a sampling line,
 Swan-Ganz catheter with a reference temperature sensor,
 Anesthetic gas probe.

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4.2 Basic rules of appropriate patient monitoring
There are some basic rules which need to be obeyed in order to ease the medical staffs’ work before
monitoring of a new patient will begin.

As far as the QynetiQ™Enterprise monitor is concerned, all necessary parameter modules should be
installed in the front panel cavity before the start of monitoring a patient.

 Only good quality ECG electrodes should be used for ECG monitoring
 Usage time of the disposable ECG electrodes is limited and should not exceed 24 hours.
 Electrode gel should be wet, not dry, what means that the electrode is still proper to use
 Metal electrode contacts should be made of a good material. They should “shine”, because it
means that they are good quality electrodes. It guarantees low impedance between an electrode
and a cable clip for the ECG signal.
 Electrodes must be adhered on a clean patient’s skin (skin must not be cleaned with a high
percentage alcohol, because it may cause drying out of the skin and makes the contact between
the ECG electrode worse).
 If the amplitude of the ECG signal is very low (less than 0.5 mV), it is recommended to rub the
skin with a special dedicated for this action, rough material, or lotion or changing the placement
of an electrode.
 Electrodes must not be applied to a hairy chest of a patient. Hair should be removed before
placing the electrodes on the patient skin.
 ECG signal amplitude must be higher than 5 mm for the sensitivity 10 mm/mV.
 If the patient’s respiration is monitored, red and yellow electrodes should be adhered as far from
each otheras possible (even under patient’s armpits, if the respiration amplitude is low). The user
may also change pairsof electrodes (used for respiration measurement).
 NIBP cuff must be placed tightly on a patient arm (so only two fingers may be shoved in with
difficulty between the cuff and the arm). Check also the marks on the cuff, to determine the
correct cuff-size.
 NIBP measurement may be not comfortable for a patient because of a compressing the arm.
That is why frequency of the measurements should be selected individually for a patient and
according to necessary medical requirements.
 NIBP cuff’s hose, which connects the monitor with a cuff, may not be bend across all its length.
Pay attention to it especially, when a patient’s arm is bend.
 The NIBP cuff should not be placed at the patient’s are where some constant injections are done.
 If the NIBP cuff is placed on the same patient arm as the SpO2 probe, then a temporarily weak
pulse waveform and lower oxygen saturation may be observed at the monitor’s screen.
 NIBP measurement must not be started, if the cuff is not placed on a patient arm because the
cuff may become damaged. This situation may occur, if the automatic measuring mode is active.
When the automatic mode is not longer required, it should be disabled. The cuff should be taken
off, rollup, and tighten with the Velcro.

QynetiQ™ Enterprise – User Manual (Version 1.5) 27


 Type and size of SpO2 probe should be chosen individually for every patient and intended placing
of the probe.
 SpO2 probe must not be placed on a nail polished finger.
 Priority should be given to an extremity free of an arterial catheter, blood pressure cuff or
intravascular infusion line, while selecting a SpO2 site.
 Do not wide open the rear tabs of the probe very hard, because its flexibility may be affected,
what may cause damaging of the probe.

WARNING!
All used disposable or reusable accessories must be original and recommended by the Fysicon,
because usage of not original parts may cause incorrect measurements and damage of the
measuring module.

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5. Creating patients and procedures

In the following chapters we will refer to a control screen and a live screen:

Control screen: The screen on which you will control the system, fill in your report, create
samples etc.
Live screen: The screen on which you will see your waveforms live (as ECG, IBP, SpO2
etc). This is the same screen as you will find in the monitoring boom in the
cathlab.

5.1 Creating a new patient

Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password

Create a new patient

Fig. 5.1

3. In this phase (fig. 5.1) it is impossible to create a new patient: the “new patient” button is not
available
4. Fill in: bb. Press enter or click the search button. No results will show
5. The “new patient” button is now available. Click the “new patient” button
6. Fill in the new patientdemographics

Create a new procedure

Fig. 5.2

7. Press the “angio” button in the button bar or choose it from the “Procedures All” list (by
clicking on the Procedures All button)(Fig 5.2)
8. Choose “new procedure”. Click yes when asked: Are you sure to save your changes?

QynetiQ™ Enterprise – User Manual (Version 1.5) 29


9. QynetiQ™ will start displaying messages:
 Procedure is starting…
 Procedure in progress…
10. Open the “Procedure (2)” tab (below the button bar). Fill in size and weight of the patient.
BMI and BSA will be calculated now
11. Open the Monitoring tab which you will find under the button “Next” (right top corner of
your screen, below the yellow close button). From here you can do yourhemodynamic
activities. See chapter 6. Procedure control
12. Close the application by clicking the yellow “close” button in the top right corner of your
screen

5.2 Opening an existing patient and create a new procedure

Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password

Open an existing patient

Fig. 5.3

3. Fill in (a part of) the last name of the patient you created before (fig. 5.3). Press enter or click
“search”
4. Double click to open the patient

Creating a new procedure


5. Choose the procedure you want to add to this patient in your button bar or in the
“Procedures All” list (by clicking on the Procedures All button)
6. QynetiQ™ will start displaying messages:
 Procedure is starting…
 Procedure in progress…
7. Open the “Procedure (2)” tab (below the button bar). Fill in size and weight of your patient
(table 1). BMI and BSA will be calculated
8. Open the QynetiQ tab which you will find under the button “Next” (right top corner of your
screen, below the yellow close button). From here you can do your hemodynamic activities.
See chapter 6. Procedure control
9. Close the application by clicking the yellow “close” button in the top right corner of your
screen

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5.3 Opening an existing patient and an existing procedure

Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password

Open an existing patient

Fig 5.4

3. Fill in (a part of) the last name of the patient you created before (fig. 5.4). Press enter or click
“search”
4. Double click to open the patient

Open an existing procedure

Fig. 5.5

5. Click the procedure you want to open in the hospitalizations & procedures list (fig 5.5).
6. QynetiQ™ will start displaying messages:
 Procedure is starting…
 Procedure in progress…
7. Open the QynetiQ™ tab which you will find under the button “Next” (right top corner of your
screen, below the yellow close button). From here you can view the samples and the full
disclosure of this procedure. See chapter 7. Sample review and 8. Full disclosure.
8. Close the application by clicking the yellow “close” button in the top right corner of your
screen.

QynetiQ™ Enterprise – User Manual (Version 1.5) 31


5.4 Monitoring the patient
You will find the monitoring tab in the tab list or in the ‘Next’ menu (fig 5.6). This depends on the
amount of tabs that are activated.

Fig5.6

In the monitoring page you can:

 Control your procedure during an active procedure (6. Procedure control)


 Review your samples during an active procedure or during a review of a previous performed
procedure (7. Sample review)
 View the full disclosure of an active procedure or during a review of a previous performed
procedure (8. Full disclosure)

32 QynetiQ™ Enterprise – User Manual (Version 1.5)


6. Procedure Control
During an active procedure the procedure control page will show automatically when you opened
the monitoring tab. If not, you can switch tabs by clicking them. When a page is opened, the name of
the tab will become blue:

Fig 6.1

Unfolding boxes

In the procedure control page you will see several boxes (Fig 6.1). By default only a few boxes are
opened/unfolded. In this case the ECG box, the IBP box and the condition boxes are unfolded by
default.

To unfold each box; press the arrows on the right top corner of the box. The box will then unfold. (fig
6.2)

Fig. 6.2

QynetiQ™ Enterprise – User Manual (Version 1.5) 33


6.1 ECG Module

6.1.1 Module description


A patient is connected to the monitor through a 3 or 5 core ECG cable. The module’s input circuit is
galvanic insulated from the rest of the monitor to ensure a good protection for the user and the
patient. Depending on requirements, the ECG module ensures monitoring of 12 leads I, II, III, aVR,
aVL, aVF and V1 – V6. The user may monitor a single lead and also simultaneously 3, 6 or 7 leads.
Monitoring of 1, 3 or 6 leads is possible, while using the 3 core cable. Monitoring of 1, 3, 6 or 7 leads
simultaneously is possible, while using the 5 core cable. The calculation of a heart rate is based on
the ECG signal. The heart rate value is displayed in the ECG window on the right side of the ECG
waveform.

6.1.2 Using the ECG module


In order to start ECG monitoring the user should:
1. Plug the ECG cable into the socket with an ECG or ECG/RESP label in the monitor.
2. Connect ECG cable endings to disposable, good quality electrodes.
3. Stick ECG electrodes on the cleaned patient’s skin. The electrodes should be placed on a
patient in accordance to the pictures below:

Connection of a 3-lead ECG cable Connection of the 10-lead ECG cable

Fig. 6.3 Fig. 6.4

 red electrode at position − R  red electrode at position − R


 yellow electrode at position − L  yellow electrode at position − L
 green electrode at position −F  green electrode at position −F
 black electrode at position −N
 white electrode at position − 1-6

34 QynetiQ™ Enterprise – User Manual (Version 1.5)


ATTENTION:
To ensure good quality and proper patient ECG monitoring, it is necessary to connect the
electrodes in accordance with the pictures and description above.
The electrodes must be adhered on the clean patient’s skin (the patient’s skin cannot be cleaned
with a high percentage alcohol solution because it may causes bad contacts of electrodes).
Electrodes must not be adhered on a hairy breast. Hair must be removed from places of electrodes
adhering.
Gel in electrodes should be “wet”, what means that they are good quality. The “spongy“ gel means
that the electrodes quality is low or the electrodes pack was opened for a long time (the opened
pack of the electrodes should be used in 2–3 weeks).
The electrodes’ clips should be “shining” – it means that they are of a good quality and ensure
good contact between the electrode and the ends of the ECG cable.
If the Amplitude of the ECG signal is very low (less than 0.5 mV), it Is recommended to rub the skin
with a special dedicated to this action rough material or a scrub gel.

WARNING!
It is recommended, that the signal on the monitor’s screen should have no less than 5 mm of
height (for the sensitivity 10 mm/mV) with the clearly visible QRS complex. If the amplitude of the
patient’s ECG signal is low, the placing of the ECG electrodes should be changed into order to
assure the higher amplitude.

The ECG cable must not hang out of the bed because the cable may become damaged.
If one set of disposable electrodes are used over 24 hours, the ECG signal can be incorrect.
The ECG cable should not beplaced next to the patient’s head because it may cause patient’s
strangulation.
If the user encounters problems with ECG monitoring (e.g. problems with Heart Rate calculation),
it is recommended to change the ECG averaging mode to “Short”.

6.1.3 ECG module settings


The user may set several options in the menu of the parameter.

Change your ECG channels

By selecting and deselecting them. When an ECG channel has a blue


edge around it;the lead is shown on the live screen.

Change the position of each lead


By moving them up and down using the arrows;

Fig. 6.5

QynetiQ™ Enterprise – User Manual (Version 1.5) 35


Change the HR Lead
By selecting the lead from the dropdown list, QynetiQ™ will
automatically recognize if a 5 or 10 leads module is inserted. It is
possible to choose basic as well as precordial leads with a 5 lead
cable. Default setting is Lead II.

Change the source of the QRS beep


By selecting the source from the dropdown list:

Fig. 6.7

Fig. 6.6
Averaging:
Choosing “Long”, “Medium” or “Short” averaging mode for HR calculation. Default setting: Medium.

Change the colors or thickness of the grid and the waves


This can be achieved by choosing a color/thickness from the dropdown lists.

Change the sound volume of QRS and Pacer beeps


This is possible by sliding the volume bars from left to right (left is silent, right is loudest):

Fig. 6.8

Change the pacer settings


With the pacer settings you can change the reference lead (which is default lead II). And you are able
to switch the pacemaker detection off (Filter on/off).

Fig. 6.9

WARNING!
If the user encounters problems with ECG monitoring (e.g. problems with Heart Rate calculation),
it is recommended to change the ECG averaging mode to “Short”.

36 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.1.4 ECG module messages
The following messages can be displayed at the monitor’s screen during the ECG monitoring:
ECG module init in Displayed only, when connection with the ECG module is being
progress initialized. It disappearsa few seconds after the main monitor’s screen is
displayed. If the message is displayedfor a longer time, it means the
module could be broken or damaged. In this situation, please contact
Fysicon Support.

ECG cable unplugged Displayed, when the ECG cable is not connected to the monitor.

Bad contact of Displayed, when the electrode is disconnected from a patient or a cable
or the high level of interferences is present.

No ECG module Displayed, when the module is not connected to the monitor.

No communication to Displayed, if the monitor cannot communicate with the module after it
was initialized.

Filter This message informs that filters are disabled.

6.1.5 Maintenance and cleaning


The ECG cable and its endings should be maintained by removing contamination using a soft cloth
moistened in water with soap. Use chemical disinfectants containing ethanol (70 % - 80 %), propanol
(70 % - 80 %) or aldehydes (2 % - 4 %).

WARNING!

Do not immerse the ECG plugs and/or cable in any liquid.

The ECG cable must not be exposed to ultraviolet radiation.

The cable should be inspected, if it is clean and has no mechanical defects, before using it.

All disposables must not be reused.

6.1.6. Accessories and ordering information


Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

QynetiQ™ Enterprise – User Manual (Version 1.5) 37


ATTENTION:
The serial number of the monitor and module should be included in your request.

Below mentioned you will find the available cables and lead wires. The items marked with an asterisk
* are supplied with the ECG module.

014240140* ECG 10-lead D-Trunk cable (without leadwires)

SPKL1099003* Radio translucent leadwireset 10 pieces 48”

6.2 Arrhythmia analysis


6.2.1 Module description
The QynetiQ™ monitors use built-in software, which enables real time analysis of more than ten
different types of arrhythmias. This analysis algorithm is based on very precise defining of QRS
complexes (sensitivity of QRS detection over 99.5%) and analysis of the ECG signal in a way, which
enables dividing the QRS complexes into normal, ventricular and supraventricular complexes.

In the next step the algorithm of the arrhythmia analysis makes the qualification to one of the
following types of arrhythmia:

Asystole lack of QRS complex for time longer than 3.5 seconds

Pause lack of QRS complex for time longer than 2.5 seconds

VF/VT Ventricular Fibrillation (VF) or Ventricular tachycardia (VT), ventricular rhythm, HR


over 130 bpm (the HR limit for VF/VT detection can be changed by the user in the
arrhythmia analysis Menu)

Bradycardia decreasing of the HR value to less than 40 bpm (this limit can be changed in the
arrhythmia analysis Menu)

STach increasing of the HR value over 130 bpm

Bigeminy detection of at least three following QRS complexes in a sequence: normal-


ventricular

Trigeminy detection of at least three following QRS complexes in a sequence normal-


normal-ventricular

VPC Run detection of 2 to 5 following ventricular complexes

38 QynetiQ™ Enterprise – User Manual (Version 1.5)


R on T early ventricular complex overlapped the T wave

VPC ventricular complex or premature ventricular complex

APC premature supraventricular complex

Atr. Fibr. Atrial fibrillation

Mis. Beat Missed QRS complex (beat)

WARNING!
The arrhythmia analysis is turned off after switching the monitor off. It can be turned on again after
switching the monitor on in the arrhythmia analysis Menu.

After enabling the arrhythmia analysis, a screen which is divided into more than ten horizontal
channels is displayed. Every channel is reserved for one type of arrhythmia. When arrhythmia is
detected by the algorithm, a small vertical line is displayed. Every type of arrhythmia has reserved its
own type of color.

The ECG signal is analyzed using one or two leads.

WARNING!
Correct analysis’ results depend on proper supervision of correct and not disturbed ECG signal
monitoring. Controlling of electrodes’ contacts is very important. It is recommended to use only
disposable electrodes as for Holter monitoring. If electrodes are inaccurately or improperly adhered,
increasing of interferences is signaled. A level of interferences (called “Signal noise”) is available at
the second channel from the bottom, above the “Irregular HR” channel. If the interferences value
exceeds 20 %, it means that analysis results could not be appropriate, because interference disturbs
the ECG signal very much.In this situation, checking of electrodes’ adhering and placing of the ECG
cable endings is recommended. Fixing of the ECG cables endings could be made using an adhesive
tape about 5 cm away from the electrodes.

6.2.2 Arrhythmia module alerts


During arrhythmia monitoring the alerts can initialized by the following types of arrhythmia:
Asystole, Pause, VF/VT, Bradycardia. These alerts have the highest (first) priority.

Alarms are presented in red colors at the upper toolbar and are labeled as follows: Alert “Asy” for
Asystole, “Pau” for Pauze, VF/VT or “Brd” for Bradycardia. In order to acknowledge one of the above
alerts, the user should press the blinking red field and the acoustic and visual signalization should be
stopped.

WARNING!

Icon informs about disabling the arrhythmia alerts and it is displayed in the left upper corner
of the screen.
QynetiQ™ Enterprise – User Manual (Version 1.5) 39
6.2.3 Maintenance and cleaning
The information about maintenance and cleaning of accessories used for the arrhythmia analysis is
described in 6.1.5 concerning the ECG module.

6.2.4 Accessories and ordering information


Accessories used for arrhythmia monitoring are the same as used for the ECG module. See 6.1.6

6.3 IBP Module


6.3.1 Module description
The QynetiQ™ monitor family enables invasive measurement of blood pressure using disposable and
reusable sensors. Depending on user’s requirements, one or two IBP channels are available. Two IBP
monitoring channels give a possibility of simultaneous IBP monitoring in two different places for
example in the brachial artery and pulmonary artery.
The measurement is made by connection of the chosen blood vessel with the sensor’s membrane.

Changes of pressure in the measuring place are transformed by an electronic system and then
displayed on the monitor’s screen as a dynamic pressure waveform in a scale chosen by the user.
Digital values, which describe three kinds of pressure: systolic, diastolic and average, are displayed in
the IBP window.

The measuring system enables monitoring of the high pressure e.g. arterial and the low pressure e.g.
a blocked pulmonary artery. Thebandwidth of the measuring system enables also precise monitoring
of shape changes of a pressure waveform. Thanks to very precise measuring sensors, it is possible to
obtain very accurate pressure values and true shapes of monitored waveforms.

6.3.2 Using IBP module


In order to start invasive blood pressure monitoring the user should:
1. Plug the red connector of the IBP extension cable to the socket labeled IBP in the monitor.
2. Connect the disposable IBP transducer to the IBP extension cable.

CAUTION:
The IBP cable connector is mechanically coded what prevents connecting the cable into other than
IBP socket. Pay attention not to connect or disconnect the cable using too much force because the
cable may become damaged.

3. Fix the IBP transducer to a tripod or stand at height, which corresponds to the place of the
IBP measurement at patient (e.g. right atrium).
4. Set the range of the displayed IBP waveform to maximum at the Menu IBP.
5. Connect the IBP transducer to one end of the sample line and saline to the second.
40 QynetiQ™ Enterprise – User Manual (Version 1.5)
6. Fix the saline container at the tripod or stand so a pressure, which allow filling in the
measuring circuit, will be present.
7. Connection of the IBP sensor to the patient should be performed in three steps.
Step 1 – filling the IBP sensor with the saline (Fig. C1.35).
Step 2 – filling the IBP sample line with the saline (Fig. C1.36).
Step 3 – preparation of the IBP sensor to the measurement (See 6.3.2.3).
8. Set the alert limits for the measured parameters.
9. Set the name of the IBP channel, which corresponds to the place of measurement.
10. Set the type of the averaging of the IBP values.
11. Optionally allow displaying the mean IBP value IMP at the field of the IBP digital values.
12. Optionally allow displaying pulse rate IPR derived from the IBP waveform.

WARNING!
The measuring system should be cleaned with a blood anti-coagulation agent, if the invasive blood
pressure is monitored for a long time. A frequency of periodic cleaning may be chosen by a doctor,
according to his practice. It should be done at least once for 2 hours of the IBP monitoring.
Special attention should be paid to the tightness of the measuring circuit because leakage will affect
the accuracy of the measurement.
Every two or three hours the tightness of the measuring should be checked, and zeroing of the
measuring circuit should be performed if necessary.

6.3.2.1 Step 1 – filling IBP sensor with saline


A. Set the long arm of the valve in the position 1 shown at figure6.10 so the saline will be able
move to the sensor’s outlet.
B. Press the tabs of the IBP sensor so the saline will fill the measuring chamber of the sensor.

WARNING!
There must not be air bubbles in the sensor’s chamber because it will cause inaccuracy in the
measured pressure values.

C. Release the tabs after the measuring changer is fully filled with the saline and perform
zeroing of the IBP channel the sensor is connected to. Zeroing can be performed after going
into the IBP Menu, choosing “Zeroing” button and pressing “Channel 1 zeroing” or “Channel
2 zeroing” depending of the currently used channel.

QynetiQ™ Enterprise – User Manual (Version 1.5) 41


POSITION 1 POSITION 2
Long arm of Tabs
sensors valve

Fig 6.10 Fig 6.11

D. Press the tabs of the IBP sensor so the saline will fill the measuring chamber of the sensor.

WARNING!
There must not be air bubbles in the sensor’s chamber because it will cause inaccuracy in the
measured pressure values.
E. Release the tabs after the measuring changer is fully filled with the saline and perform
zeroing of the IBP channel the sensor is connected to. Zeroing can be performed after going
into the IBP Menu, choosing “Zeroing” button and pressing “Channel 1 zeroing” or “Channel
2 zeroing” depending of the currently used channel.

WARNING!
Zeroing can be performed only when the valve arm is in position 1.

6.3.2.2 Step 2 – filling IBP sample line with saline


A. Close the connection of the sensor membrane with the sensor’s outlet by a quick turn
(about 180)of the long armof the valve into position 2 shown at figure 6.11.
B. Fill in the sample line from the patient side completely with saline (e.g. using the syringe put
the saline liquid with the blood anti-coagulation agent). Suck out the air so the measuring
part of the system is filled with the liquid without any air bubbles.

CAUTION:
There must not be air bubbles in the sample line and the sensor’s inlet because it will cause
inaccuracy in the measured pressure values.

6.3.2.3 Step 3 – preparing the IBP sensor for measurement


A. Set long arm of the valve in position 3 as show at figure 6.12. The user may perform the
invasive pressure measurement in this position of the valve.
B. Set the range of the displayed pressure waveform adequately to measured pressure values.

42 QynetiQ™ Enterprise – User Manual (Version 1.5)


POSITION 3

Fig. 6.12

6.3.3 IBP module settings


The user may set several options in the menu of the parameter.

Fig. 6.13

Select/deselect IBP channels


By selecting/deselecting the IBP box. When a box has a blue edge, it means that that IBP channel is
selected and shown on the live screen:

Fig. 6.14

Change the label of an IBP channel


By choosing the correct label from the dropdown list:

Fig. 6.15
A label can also be changed afterwards in the sample review page (see chapter 5.4.2 Sample review)

Change the color of an IBP channel


By choosing the correct color from the dropdown list:

Change the position of an IBP channel


By moving them up and down using the arrows:

Fig. 6.16

QynetiQ™ Enterprise – User Manual (Version 1.5) 43


Activate or turn of the display of a heart on the live screen
By selecting the heart or deselecting it (click on the heart).
When the heart box has a blue edge, it means that the heart is activated and shown on the live
screen. The heart is not active by default.

Zeroing the IBP channels


One by one by clicking on the channel box or all the channels at once by clicking the ‘all’ box:

Fig. 6.17

On top of the QynetiQ™ control screen you will find the QynetiQ™ toolbar, by clicking on the QynetiQ
button you can select the Zero All option as well.

Fig. 6.17a

Fig. 6.17b

Change the IBP grid color


Open more IBP settings by clicking the arrow on the bottom of the box:

Fig. 6.18

From here you can change the grid color and thickness by choosing the color and thickness from the
dropdown list. You can also add grid subscales by choosing the desired subscale from the dropdown
list.

When you select ‘Description’, the IBP labels will show on the live screen as well as the scale
numbers. When the box has a blue edge, it means that the description is on.

44 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.3.4 IBP module messages
The following messages can be displayed at the monitor’s screen during the IBP monitoring:
IBP module init Displayed after switching on the monitor, when a connection with the
IBP module and a system is being started. Usually the message
disappears a few seconds after a mainscreen displaying. If the
message is displayed for a longer time and does not disappear,the
module could become damaged and the manufacturer’s service
should be contacted.

IBP sensor unplugged Displayed, when the IBP sensor is not connected to the IBP extension
cable or if theIBP extension cable is not connected to the monitor.

No IBP module Displayed, when the IBP module is not connected to the monitor.

Channel 1 (or 2) zeroing Displayed while zeroing each of the IBP channels.

No communication to IBP Displayed when there is no communication to the IBP module after
module the module initialization.

6.3.5 Maintenance and cleaning


The IBP extension cable should be maintained by removing contamination using a soft cloth
moistened in water with soap.
Use chemical disinfectant solutions containing ethanol (70% - 80%), propanol (70% - 80%) or
aldehydes (2% - 4%).

CAUTION:
Do not immerse the IBP extension cable plugs and/or cable in any liquid.
The IBP extension cable must not be exposed to ultraviolet radiation.
The cable should be inspected, if it is clean and do not have any mechanical defects, before using it.
All disposables must not be reused.

6.3.6 Accessories and ordering information


Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

ATTENTION:
The serial number of the monitor should be included in the order.

Below mentioned you will find the available cables. The items marked with an asterisk * are supplied
with the IBP module.

014240401 * IBP Cable to Becton Dickinson

QynetiQ™ Enterprise – User Manual (Version 1.5) 45


014240402 IBP Cable to Medex

014240403 IBP Cable to Namic

014240404 IBP Cable to Utah Medical, ADI

014240405 IBP Cable to Edwards Life-Sciences

6.4 Condition settings

Fig. 6.19

Change the condition of the patient


From here you can change the condition of the patient during the procedure. Default condition is
‘Rest’. You can change it in (for example) Pre PCI, Post PCI or medication study

6.5 Presets

Fig. 6.20

Predefined preset
Here you can switch to a predefined preset by choosing the preset from the dropdown list, for
example ‘CoronaryAngiogram_2IBP’. In this list you will find predefined system presets and presets
you created.

Making your own preset


Open more IBP settings by clicking the arrow on the bottom of the box:

Fig. 6.21

If you have set your ECG settings and IBP settings and you would like to have these settings saved as
a preset, you can give in a name and click ‘Save user preset’. The preset is now saved and you can
pick the preset from the dropdown list anytime.

46 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.6 Timers

Fig. 6.22
It is possible to set one single timer or two timers at once. There can be chosen for one or two count
up timer(s) or one or two countdown timer(s) or one count down timer and one count up timer.

Timer 1 is default a countdown timer and Timer 2 is default a count up timer. (The on button behind
‘count up’ has a blue edge)

Set the countdown timer


Click the Timer 1 button. The timer is now visible on the live screen. You can choose a name for the
timer in the ‘Name’ dropdown list and set the time for the timer.

Set the count up timer


Click the Timer 2 button. The timer is now visible on the live screen. You can choose a name for the
timer in the ‘Name’ dropdown list and set the time for the timer.

If you press the ‘on’ button behind count up (for both timers) you can change from count up to count
down and vice versa.

6.7 Alerts

Fig. 6.23

Change the alert mode


In the Alert Mode dropdown list you will find several alert modes. With the reset button you reset
the alarm. With the sliders you can change the alert disable time, the alert sound volume and the
inop sound volume. In the following table you will find the different alert modes:

QynetiQ™ Enterprise – User Manual (Version 1.5) 47


Icon on live
Alert Mode:
screen:

Active: All alarms enabled.

Still: Acoustic signaling of the alarms disabled.

Suspended: All alarms temporarily disabled.

Disabled: All alarms completely disabled. Additionallya blinking red


field, with a text “Alerts off”is displayed at the upper toolbar.
For more information about alerts, see chapter 6 Alarms.

48 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.8 Respiration

6.8.1 Module description


Respiration monitoring uses an impedance method. It means that the changes in patient’s breast
impedance are measured during breathing.

The input circuit of the respiration path – similarly as in the ECG path – is galvanic insulated from the
rest of the device to ensure a full protection for the patient and the user. The same electrodes are
used as during the ECG monitoring. Changes of the breast impedance between two electrodes are
presented in form of a waveform on the monitor’s screen. One of two pairs of electrodes is used for
the respiration detection:
 RA (red) with LA (yellow),
 RA (red) with LL (green).

Respiration rate is derived by the analysis of the respiration waveform. One of the most important
parameters, besides respiration rate monitoring, especially during neonatal monitoring, is apnea
supervision. Delay time before Apnea alarm initialization may be set in the respiration menu
depending on requirements for the patient.

6.8.2 Using respiration module


All the rules described in the chapter concerning ECG monitoring must be also obeyed during
respiration monitoring. However, because of the fact that the respiration monitoring is very specific,
the user should especially pay attention to a place of adhering the red and the yellow electrodes.

WARNING!
The red-yellow pair of electrodes should be adhered at the furthest distance from each other.
It is recommended to set highest possible respiration signal amplitude on the monitor’s screen.
If the respiration signal amplitude is low even after setting the highest amplitude, the user should
try changing the pair of electrodes from the standard red-yellow (RA-LA) to red-green (RA-LL) pair
in the respiration Menu.
In case of a very low signal’s amplitude, the electrodes should be adhered even under the patient’s
armpits.

6.8.3 Respiration module settings


The user may set several options in the menu of the parameter.

Fig. 6.24

QynetiQ™ Enterprise – User Manual (Version 1.5) 49


Change sensitivity of the respiration
Choose the sensitivity from the dropdown list

Change the electrode


Changing a pair of electrodes used during respiration monitoring. Available pairs: RA-LA or RA-LL.
Default pair: RA-LA.

6.8.4 Respiration module messages


The following messages can be displayed at the monitor’s screen during the respiration monitoring:
Respiration module init in Displayed when connection with the ECG module is being initialized.
progress It disappears a few seconds after the main monitor’s screen is
displayed. If the message is still displayed, it means the module could
be broken or damaged. In this situation please contact Fysicon
Support.

ECG cable unplugged Displayed when the ECG cable is not connected to the monitor.

No contact of electrodes Displayed when a disposable electrode is disconnected, the ECG cable
and/or leads are damaged.

Bad contact of electrodes Displayed when an electrode or electrodes is either not adhered
properlyor has a badcontact with the patient’s chest.

No respiration module Displayed when the ECG module is not connected to the monitor.
No communication to Displayed when there is no communication to the ECG module after
respiration module the moduleinitialization.

Respiration module off Displayed, when the respiration analysis is disabled.

6.8.5 Maintenance and cleaning


The information about maintenance and cleaning of accessories used for the respiration monitoring
is described in the point 6.1.5 concerning the ECG module.

6.8.6 Accessories and ordering information


Accessories used for respiration monitoring are the same as used for the ECG module. See 6.1.6.

50 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.9 Pulse Oximetry module – SpO2

6.9.1 Module description


The pulse oximetry module measures the content of the oxygen in the blood. It is an optical method
of measurement using the sensor, which is placed e.g. on the patient finger.

To ensure protection, the measuring system of the pulse oximeter is galvanic insulated from the
patients and the user.

The pulse oximetry module ensures the continuous measurement and supervision of the oxygen
content in the arterial blood. It also ensures the continuous monitoring of the peripheral pulse rate.
The measurement is based on monitoring of the light (660 nm and 940 nm) transmission through the
vascularized tissue (e.g. the finger) and deriving the light absorption, what informs about SpO2 value.

The known phenomenon of changing of the blood color together with changing of the oxygen
content in the blood is used during the measurement of the blood oxygenation. The sensor placed
e.g. on the finger (transmitter) transmits the light beam to the receiver through the finger. The signal
detected in the receiver is analyzed by the electronic system and the algorithm calculates the oxygen
saturation.

6.9.2 Using the SpO2 module


In order to start SpO2 monitoring the user should:
1. Choose a type of sensor which will be used for the SpO2measurement. There are two basic
types of the reusable sensors: finger sensor (Fig. 6.25) and “Y” type sensor (Fig. 6.26).

Fig. 6.25 Fig. 6.26

2. Place the sensor in the chosen for measurement site e.g. at patient’s finger (Fig. 6.27) or at
patient’s ear in position a) or b) (Fig. 6.28).

QynetiQ™ Enterprise – User Manual (Version 1.5) 51


Fig. 6.27 Fig. 6.28

WARNING!
Place the sensor in a position, which will assure that the sensor windows are against each other,
while a patient’s tissue is being tested and secure its position.
The sensor should be place in a way, which will not worsen the blood circulation because it will
cause incorrect measurement of SpO2 and pulse rate.
Reusable sensors may be used on the same site for maximum 4 hours, provided the site is
inspected routinely to ensure skin integrity and correct positioning. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change
the sensor site more frequently with some patients.

3. Connect the sensor to the extension cable and then the extension cable plug to the SpO2
socket in the monitor.
4. Pulse waveform the SpO2 value and pulse rate value will be displayed at the monitor’s screen
within a few seconds.

WARNING!
If a message “Pulse detection” is displayed at the monitor’s screen for a long time, it is suggested to
change the sensor’s site.

5. Set the alert limits for the SpO2 and Pulse rate.
6. Set the averaging time for SpO2 measurement.

CAUTION:
Failure to apply the sensor properly may cause incorrect measurements. Any pressure that limitsthe
blood flow in the extremities testing causes that the measurements are wrong.
If an NIBP cuff is placed at the same extremity as the pulse oximetry sensor, then during the NIBP
measurement there can be a temporary pause in the SpO2 measurement. The pulse oximeter will
measure the oxygen saturation again when the cuff pressure falls below the diastolic pressure.
In order to start the SpO2measurement as soon as possible, place the sensor at the patient before
connecting the sensor into the monitor’s SpO2socket.
Using the sensor in the presence of bright lights may result in inaccurate measurements. In such
cases, cover the sensor site with an opaque material.
Reusable sensors must be moved to a new site at least every 4 hours. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change
the sensor site more frequently with some patients. If skin integrity changes, move the sensor to
52 QynetiQ™ Enterprise – User Manual (Version 1.5)
another site.
Use only that wraps designed for use with this sensor. Do not use tape. Use of additional tape or
various other types of wraps can cause skin damage.
Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream, may
lead to inaccurate measurements.
It is recommended to use “Y” sensors for neonates monitoring. Special wraps and tapes allow quick
and reliable fixing at the patient’s body.
Excessive motion may compromise performance. In such cases, try to keep the patient still, or
change the sensor site to one with less motion.
When the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead
to inaccurate saturation measurements.
As with all medical equipment, carefully route cables to reduce the possibility of patient
entanglement or strangulation.
Do not use the sensor or other oximetry sensors during MRI scanning. Conducted current may cause
burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of
oximetry measurements.
Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
If the pulse oximetry sensor is not used for monitoring but the monitor is switched on, it is suggested
to unplug it from the monitor’s socket because it will extend the life of the sensor.

It is recommended to place the “Y” sensors as shown at the figure Fig. 6.29.

Fig. 6.29

It is recommended to fix the yoke part of the “Y” sensor using an adhesive tape, so the sensor’s
endings or not stretched or moved during the monitoring, because it will cause problem with
continuous oxygen saturation measurement and a message “Pulse detection” may be displayed
frequently.

6.9.3 SpO2 module settings


The user may set several options in the menu of the parameter.

Fig. 6.30

QynetiQ™ Enterprise – User Manual (Version 1.5) 53


Averaging
This functionality enables the user to changethe method of averaging the measured values. Available
setting: long and normal. Default setting: Normal.

Enabling SpO2 waveform


Press the heart to enable SpO2

6.9.4 SpO2 module messages


The following messages can be displayed at the monitor’s screen during the SpO2 monitoring:
SpO2 module init in Displayed when connection with the SpO2 module is being initialized. It
progress disappears a few seconds after the main monitor’s screen is displayed.
If the message is still displayed, it means the module could
be broken or damaged. In this situation please contact Fysicon
Support.

SpO2 probe unplugged Displayed when the SpO2 sensor is not connected to the monitor.

Probe of patient Displayed when the sensor is not placed on the measuring site or it has
partly slipped off.

Searching for pulse Displayed directly after placing the sensor on the measuring site or
whenbiginterferences are present.

Selftest error Displayed when the sensor is damaged. Please contact the Fysicon
Support.

No SpO2 module Displayed when the module is not connected to the monitor

No communication to SpO2 Displayed when there is no communication to SpO2 module after the
module module initialization.

6.9.5 Maintenance and cleaning

CAUTION:
All disposables must not be reused.

6.9.5.1 Reusable finger sensor and extension cable


The finger sensor may be surface-cleaned by wiping it with a solution such as 70 % isopropyl alcohol.
If low—level disinfection is required, use a 1:10 bleach solution. Do not use undiluted bleach (5%-
5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because
permanent damage to the sensor could occur.

CAUTION:

54 QynetiQ™ Enterprise – User Manual (Version 1.5)


Do not expose connector pins to cleaning solution as this may damaged the sensor.

To clean or disinfect the sensor the use should:

1. Saturate a clean, dry gauze pad with cleaning solution. Wipe all surfaces of the sensor and
cable with this gauze pad.
2. Saturate other clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the
sensor with this gauze pad.
3. Dry the sensor and cable by wiping all surfaces with a clean, dry gauze pad.

CAUTION:
Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization will damage the sensor.

6.9.5.2 Reusable “Y” sensor


To clean or disinfect the sensor using the recommended soak method:

1. Place the sensor in the cleaning solution, such that the sensor head(s) and desired length of
cable are completely immersed.

CAUTION:
Do not immerse the connector end of the cable as this may damaged the sensor.

2. Dislodge air bubbles by gently shaking the sensor and cable.


3. Soak the sensor and the cable for 10 minutes.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room temperature sterile or distilled water for 10 minutes.
6. Remove from the water.
7. Dry the sensor and cable by wiping all surfaces with clean, dry gauze.

CAUTION:
Using excessive force when removing the disposable wrap may damage the sensor.

6.9.5.3 Ear clip for the reusable “Y” sensor

CAUTION:
In order to avoid damaging the “Y” sensor, remove the sensor before cleaning both parts.

In order to remove the “Y” sensor from the clip, press rear tabs of the clip and delicately slide out the
sensor heads. Do not pull the head cable while removing the head from the clip.
The clip should be cleaned after its every usage.
In order to clean the clip, it should be wiped and immersed (for 10 minutes) in is isopropyl alcohol
(70%). If the clip is immersed, then it should be washed with water and dry it out before the next
usage.
QynetiQ™ Enterprise – User Manual (Version 1.5) 55
CAUTION:
Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization will damage the sensor.

Fig. 6.31

The sensor should be inspected before its every usage.

The clip should be disposed in case the force of the clip’s spring is lowered because it will cause
movingthe “Y” sensor in the place of measurement. This may affect performance or accuracy.

6.9.5.4 Adhesive tapes


Adhesive tapes used for fixing the “Y” sensor on the patient body should be treated as disposables
and disposed in accordance with the local regulations.

6.9.6 Accessories and ordering information


Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

ATTENTION:
The serial number of the monitor and module should be included in your request.

Below mentioned you will find the available cables, probes and accessories. The items marked with
an asterisk * are supplied with the SpO2 module.

014240200* SpO2 extension cable - Nellcor

014240201* Nellcor SpO2 reusable finger sensor

014240202 Nellcor SpO2 reusable “Y” sensor

014240203 Nellcor Ear clip for “Y” sensor

014240204 Posey wrap (band) for “Y” sensor

56 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.10 Temperature module

6.10.1 Module description


The module measures temperature using a thermistor probe placed on the patient’s skin or in the
patient’s cavity. The module’s input circuits are galvanic insulated from the rest of the monitor to
ensure a proper protection for the user and the patient. The very accurate measuring system,
together with the very accurate probes, ensures the measurement resolution of 0.1C. Temperature
may be measured simultaneously in two different sites with ability to derive the differences in
temperatures. The measurement could be made on the patient’s skin and in patient’s cavity.

Measuring values are displayed as digital values and trends, similarly to the other parameters.

6.10.2 Using the temperature module


The monitor allows measuring of temperature using one or two skin probes
or central probes.

In order to start temperature monitoring the user should:


1. Plug the temperature probe connector to a monitor’s socket labeled T1 (or T2).
2. Place the probe in or at the patient (e.g. as shown at figure 6.32).
3. Fix the probe and the probe’s cable with an adhesive tape (e.g. as shown at figure 6.32).

WARNING!
The measured temperature values are stabilized within about 3 minutes.
The probe must not press the blood vessel.
Use only water-based crèmes for introduction a central probe.
Introduction of the probe may induce nose bleeding.
Use disposable protective sheets during rectal applications.
Different parts of the body may differ significantly in temperature. Monitoring temperature from
two different sites, e.g. esophagus and extremity, provides indirect information on the blood flow.

1. Set alarm limits for the monitored parameters.


2. Set a temperature channel name.
3. Optionally allow displaying difference temperature ΔT between T1 and T2.

6.10.2.1 Types of temperature probes – Skin Probes


Skin probes should be installed on the patient’s skin, and fixed to a finger or toes using an adhesive
tape. The adhesive tape should be adhered to the contact site and additionally in a small distance
from this site, what will ensure more precise adhesiveness of the probe to the patient’s skin.
Make sure that a proper contact between the probe and the skin is ensured because it affects the
accuracy of the measurement. The temperature measurement values stabilize after approximately 3
minutes.

QynetiQ™ Enterprise – User Manual (Version 1.5) 57


Fig. 6.32

6.10.2.2 Types of temperature probes - Central probes


Central Probes are used in e.g. the esophagus, the nasopharynx or the anus. Water based creams
should be used for inserting the probes. Additionally the probe should be fixed to the patient’s skin a
few centimeters from the inserting point. This ensures a steady position of the probe.

Fig. 6.33

The measurement in the esophagus should be made below the forth esophagus’ part.

Esophagus Nasopharynx
Fig. 6.34

The measurement in the anus should be made, when the measuring probe’s end passes the
sphincter. We recommend using the disposable protection covers PC1 (Fig. 6.35)

Fig. 6.35

58 QynetiQ™ Enterprise – User Manual (Version 1.5)


WARNING!
Central probe should be disinfected immediately after using.
Central probe must be inspected for any mechanical damages before every usage.

6.10.3 Temperature module settings


The user may set several options in the menu of the parameter.

Fig. 6.36

Switch place where the temperature is taken


For each channel (1 and 2) you can set where the temperature is measured. Choose the correct place
from the dropdown list

Switch on/off the display of the delta temperature


When you select the button ‘on’, de delta temperature will be shown on the live screen. When the
box has a blue edge, it means that de delta temperature will be shown

6.10.4 Temperature module messages


The following messages can be displayed at the monitor’s screen during the temperature monitoring:
Temp module init in Displayed after switching on the monitor, when a connection with the
progress Temp module and a system is being started. Usually the message
disappears a few seconds after a mainscreen displaying. If the
message is displayed for a longer time and does not disappear,the
module could become damaged and Fysicon Support should be
contacted.

Temperature sensor Displayed, when the temperature sensor is not connected to the
unplugged monitor.

No temperature module Displayed, when the temperature module is not connected to the
monitor.

No communication to Displayed when there is no communication to the IBP module after


temperature module the module initialization.

QynetiQ™ Enterprise – User Manual (Version 1.5) 59


6.10.5 Maintenance and cleaning
Remove adhesive tape, use cleaning benzene to remove rests of adhesive. Clean with a cloth
dampened with soap water.
CAUTION:
Do not immerse connector in a cleaning solution.
Do not use harmed or defective probes.
All disposables must not be reused.

Use ethanol and isopropyl alcohol 70% for disinfection.

6.10.6 Accessories and ordering information


Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

ATTENTION:
The serial number of the monitor should be included in the order.

Below mentioned you will find the available probes and accessories. The items marked with an
asterisk * are supplied with the Temp module.

014240501 Central temperature probe – Adults

014240502 Central temperature probe – Children

014240503 Central temperature probe – Neonates

014240510 * Skin temperature probe – Adults

014240511 Skin temperature probe – Children

014240512 Skin temperature probe – Neonates

014240504 Disposable protective sheets (box 100 pcs)

60 QynetiQ™ Enterprise – User Manual (Version 1.5)


6.11 Non-invasive blood pressure module – NIBP

6.11.1 Module description


The NIBP module measures the blood pressure using oscillometric method. It means that the
changes of the pulsating pressure amplitude are measured in the cuff placed on the patient’s arm.
The measurement is made when the cuff is filled with the air until it reaches the pressure
comparable to the patient’s systolic pressure.

The measurement may be initialized manually or automatically in differentiated intervals between


measurements (range: 1 – 480 minutes). The cuff is filled with the air by the internal compressor. In
order to reduce difficulties of this method (often pressing of the patient’s arm) the managing
software of the module, automatically adapts parameters of the measurement to the patient’s
characteristic by an initial analysis of the pressure, the heart rate and the amplitude of the dynamic
pressure signal.

The measurement is made during deflation of the air from a cuff, after it is filled with the air to the
pressure that exceeds the systolic pressure for about 30 mm Hg. If the algorithm could not measure
the blood pressure, then a new measurement is initiated with new initial parameters (e.g. upper
pressure is set to a higher value). The values of the systolic, diastolic and average pressure are
displayed in the NIBP window after the measurement is accomplished. The module managing
software has a built-in protection against damaging including overpressure protection: > 300 mmHg
– for adults and > 150 mmHg – for neonates.

6.11.2 Using the NIBP module

WARNING!
The patient should be relaxed and calm before performing a NIBP measurement. Even a small effort
(making a few steps) or a situation, when patient is upset may cause increasing of the patient’s
pressure.

In order to start non-invasive blood pressure monitoring the user should:


1. The patient should be informed about difficulties concerning arm pressing by the air pumped
into the cuff.
2. The arm should not be moved during the measurement.

CAUTION:
The cuff’s size should be appropriately chosen according to the size of the patient’s arm. Using
an improper size of the cuff may cause incorrect measurement.
3. Place the NIBP cuff at the patient forearm in a position shown at figure 6.37 so an arrow
drawn at the cuff is directed to the artery. The cuff should be placed about 2 cm about the
arm.
4. The arm should not be moved during the measurement.

QynetiQ™ Enterprise – User Manual (Version 1.5) 61


Fig. 6.37

5. Connect the air hose of the cuff with the NIBP extension hose and then the extension hose
with the monitor’s socket marked with “NIBP” label. The connections are made by quick-
connectors which enable quick and reliable pneumatic connections and easy disconnection.
6. Choose a working modus (adults or neonates), set a proper pressure level for the first
measurement and set required alert limits.
7. Optionally set the automatic NIBP measurement. It allows automatic initialization of
measurement after a specific time interval.

CAUTION:
The incorrectly installed cuff on the patient’s arm may be a source of improper results of the
patient’s blood pressure measurement.
Make sure that the hose between the monitor and the cuff is not bent.
The cuff must be wrapped after finishing the automatic measurement because the cuff may
become thorn apart, if the compressor is started.

6.11.2.1 “On demand” measurement


Choose a configuration of the screen with displayed values of SP systolic pressure, DP diastolic
pressure and optionally MAP average pressure. Press “START NIBP” button in the toolbar to start the
compressor and filling the cuff with the air.

“NIBP measurement” text and the current value of the air pressure in the cuff is displayed in an NIBP
window. An initial analysis of parameters is made during filling the cuff with the air in order to define
the initial conditions for the measuring algorithm. When the pressure reaches a required level, the
compressor stops working and a procedure of the pressure detection is started. The pressure in the
cuff will be deflated in steps.

If the systolic pressure is not detected (e.g. the upper cuff pressure was too low or a dynamic
pressure signal is too weak) the measurement will be repeated with the higher initial pressure (about
30 mmHg higher) or with a more amplified dynamic pressure signal.

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However, if the module detects the systolic pressure, it measures the mean and diastolic pressure
andthen the cuff is deflated. The measured digital values of the pressure (systolic, diastolic and
optionally mean) will be displayed in the NIBP window.

If the “Stop NIBP” button is pressed during the measurement, the measurement will be terminated.

6.11.3 NIBP module settings


The user may set several options in the menu of the parameter.

Fig. 6.38

Start an NIBP measurement manually


Click the square NIBP button to start a NIBP measurement

Display the mean of NIBP


Turning the mean pressure displaying on or off. Default value: Off

Mode select
Choosing the working mode depending on a monitored patient
(Adult or neonates).

6.11.4 NIBP module messages


The following messages can be displayed at the monitor’s screen during the NIBP monitoring:
NiBP module init in progress Displayed when connection with the NiBP module is being
initialized. It disappears a few seconds after the main monitor’s
screen is displayed. If the message is still displayed, it means the
module couldbe broken or damaged. In this situation please
contact Fysicon Support.

NiBP measurement Displayed during the NiBP measurement.

NiBP measurement break Displayed when the NiBP measurement is terminated using the
“Stop NiBP” button in the lower toolbar.

No cuff Displayed during the NiBP measurement, while the cuff is not
connected to the module.

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Air leak Displayed is there is an air leak detected in the measuring system
(e,g, in the cuff, the hose or the pressure valve in the module).

Kinked hose Displayed when the module detects an incorrect air flow in the
hose between the patient’s cuff and the monitor.

No communication to NiBP Displayed when there is no communication to NiBP module after


module the moduleinitialization.
Cuff positioning error Displayed when the cuff is installed not tight enough on the
patient’s arm.

Overpressure Displayed when the overpressure safety limits are exceeded.

Out of range Displayed when the patient’s pressure is out of the measuring
range of the NIBPmodule.

Excessive motion Displayed when a big disturbance is presented during the


measurement, what makesimpossible to measure the pressure (e.g.
arm motions, repeated cuff hose tightening,leaning on or moving
the hand with the cuff installed or arrhythmia disturbances).

Measurement time-out Displayed when the measurement is not accomplished during a


time determinedby the producer (usually the measurement lasts
about 40 seconds).

NiBP module failure Displayed when the NIBP module does not responds to monitor’s
commands.

No NiBP module Displayed when the module is not connected to the monitor.

No communication to NiBP Displayed when there is no communication to NIBP module after the module
module

6.11.5 Maintenance and cleaning


For normal cleaning use a mild detergent/dilute bleach solution (1-2%), wipe the cuff with the
cleaning solution and wipe a cloth moistened in water and dry.

For disinfecting use a solution, such as Enzol, Cideyzene, Cidex, Sporicidin, Isopropyl alcohol (70%),
Ethanol (70%), wipe or spray the BP cuff and allow standing for approximately one minute. Than
wipe a cloth moistened in water and dry.

CAUTION:
If the blood pressure cuff has been grossly contaminated with blood or other bodily fluids, it should
be discarded.
If the cuff is submerged in the cleaning or disinfecting solution, the fittings should be capped to
prevent the liquid from getting inside the cuff.
The liquid should not come into the pumping circuit because it may cause damaging of the module.
All disposable or single patient use cuffs should not be reused.

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6.11.6 Accessories and ordering information
Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

Below mentioned you will find the available cuffs and accessories. The items marked with an asterisk
* are supplied with the NiBP module.

014240301 Disposable Cuff 2 (4-8cm) - Neonates

014240302 Disposable Cuff 3 (6-11cm) - Neonates

014240303 Disposable Cuff 4 (7-13cm) - Neonates

014240304 Disposable Cuff 5 (8-15cm) - Neonates

014240305 Reusable Cuff XS (12-19cm) - Children

014240306 Reusable Cuff S (17-25cm) - Children

014240307 * Reusable Cuff M (26-35cm) - Adults

014240308 Reusable Cuff L (31-40cm) - Adults

014240300 * NIBP extension hose, 250 cm

6.12 Cardiac Output module – CO


6.12.1 Module description
The Cardiac Output (CO) is a basic hemodynamic parameter, which mentions the heart sufficiency by
determining the blood volume, which the heart pumps during one minute of its work. The COmodule
is designed for measuring and monitoring the cardiac output mean value, determined by averaging
the series of invasive right ventricle output measurements. The thermo dilution method is utilized for
the CO measurement.

The CO measurement is realized using the time analysis of the thermal indicator concentration
changes in circulating blood. The measuring method of the module is based on impulse injection of
specified volume of injection solution (3 or 5 or 10 cc saline with determined temperature) through
Swan-Ganz catheter directly into the right atria and the analysis of the temperature changes in the
pulmonary artery (PA) trunk recorded with the thermistor of the same Swan-Ganz catheter. The
value of each individual CO measurement in the session is calculated basing on areaof surface under
the curve of recorded temporary temperature changes.

QynetiQ™ Enterprise – User Manual (Version 1.5) 65


CAUTION:
The accuracy of individual CO measurement strongly depends on accuracy of measuring and
application of injection solution volume as well as correct temperature of this solution and its
measurement.

QynetiQ™ Monitors allow an indirect measurement of a temperature of the injections solution in a


additional non-sterile container by an elastic temperature probe. This container contains a solution
of the same composition and temperature as a solution used for injections through the Swan-Ganz
catheter.

CAUTION:
Injection solution, which will be injected to Swan-Ganz catheter, must be sterile. That is why it is
not acceptable to introduce non-sterile elastic temperature probe to a container with a sterile
injection solution which is used for injections through the Swan-Ganz catheter.

In clinical practice the CO, the parameter used for patient’s hemodynamic status examination, is
calculated as a mean value of a few individual measurements collected in one session. The
measurements in a single session typically are performed directly one after another. The CO module
allows CO calculating as the mean value in the session of from 1 up to 6 individual measurements. It
is possible to edit each individual measurement in the session by marking doubtful measurements
and making new measurements instead of the marked ones. The maximum session capacity is 6
individual CO measurements. If the number of individual measurements is prolonged and exceeds 6
measurements, each new measurement will replace the oldest one or a marked as doubtful one.
Such a replacement needs to be confirmed by the user.

The CO value in resting conditions at healthy man hearts in within a range from 4 to 8 l/min and it is
strongly dependent from patient's body weight and height. Therefore the more significant usage has
a calculation of the standardized cardiac output, related to patient's body surface area (BSA), and
called the Cardiac Index (CI). The QynetiQ™ monitors realize the automatic CI calculation by dividing
the CO value by BSA. The only condition necessary for that is that the patient's and height and weight
were earlier introduced in the patient's data screen. The monitors present both results
simultaneously as standard: the pure CO value as well as standardized CI index.

The average value of CO and CI appointed in session along with results of individual measurements in
the session could be recorded in memory the monitor for a trend analysis of parameters changes.
These values could to be also utilizing for computation of the hemodynamic calculations of patient
circulation system by Hemodynamic Calculations software. The Hemodynamic Calculation software is
a data acquisition tool offered as option in the monitor.

In case of temporary break of measuring session and exit from CO module screen, the module allows
continuation of the broken session. It is the user’s responsibility to verify the examination conditions
(the patient hemodynamic status, injection solution temperature, etc.) and make the decision either
the broken session could be continued or the next session with new measurements should be started
from the beginning.

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6.12.2 Using the Cardiac Output module – CO

CAUTION:
The usage of the Swan-Ganz thermo dilution catheters recommended by the monitor’s
manufacturer is crucial for proper CO module work and accurate cardiac output estimation.

6.12.2.1 Preparation for Cardiac Output measurement


In order to prepare the module to work the user should:
1. Connect the CO module interface cable to the socket, marked with a CO label, at the front
panel of the monitor.
2. Connect injection solution temperature probe with socket in external port of CO module
interface cable.

To CO module

socket
Swan-Ganz catheter
Thermistor connector

Reference
temperature
sensor
connector

Fig. 6.39

3. Connect the connector of Swan-Ganz catheter with the socket of the CO module interface
cable. The thermistor has been already properly introduced into patient vascular system for
the cardiac output examination using thermo dilution technique.

WARNING!
The proper localization of Swan-Ganz catheter thermistor in the trunk of pulmonary artery as well
as setting the outlet of injection port directly in right atria is crucial for accurate cardiac output
estimation.

4. Prepare the sterile injection solution with proper temperature for CO examination and the
additional container with non-sterile solution about identical temperature like sterile
injection solution prepared for examination. The additional container with non-sterile
solution will be used for measurement of reference injection temperature.

WARNING!
The difference between temperatures of injection solution (delivered during examination through
the Swan-Ganz into the right heart) and the reference injection solution (non-sterile in additional

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container)is the reason of fundamental error introducing in CO individual measurement with this
technology.

5. Introduce the external temperature probe, used for measuring the temperature of the
injection solution, properly into the middle of additional container with non-sterile reference
injection solution, and protect its stable position.
6. Go into the Menu CO in order to start managing the CO module.
7. Press “Measurement” button in the CO menu (in the mode dropdown list). See figure6.40
8. If CO measurement has been already performed or has been paused a message asking if the
user wants to start a new session or continue the previous session will be displayed. Choose
the appropriate option.

WARNING!
The continuation of earlier paused session makes the sense only then when the essential change of
conditions of CO examination did not occur - the patient's status, the catheter placement, and
temperatures of both: blood and injection solution.

WARNING!
An improper CC value causes a fundamental error in CO value estimation and consequentially in the
CI value.

9. The new screen will be displayed. Check the indications of the patient's blood temperature -
Tblood (measured by the Swan-Ganz catheter thermistor located in pulmonary artery) as
well as the temperature of injection solution Tinj (measured by the external temperature
probe in container with non-sterile reference injection solution). If temperatures are correct
the user can start the measurement.

6.12.2.2 Cardiac output measurement


1. After performing the actions described in 6.12.2.1 the module is ready for
thenewmeasurement and a message “Ready for new measurement” announcement over the
blood temperature-time axes is displayed.
2. Fill the syringe with the demanded volume of sterilized injection solution.

WARNING!
The temperature of the injection solution that exceeds the proper temperature range for the
chosen computation constant causes the fundamental error in the CO value measurement and
consequentiallyin the CI value.
The difference between temperatures of injection solution (delivered during examination through
the Swan-Ganz into the right heart) and the reference injection solution (non-sterile in additional
container) is the reason of fundamental error introducing in CO individual measurement with this
technology.

3. Connect syringe to the port of Swan-Ganzthermo dilution catheter.


4. Press the”Start CO” button at the screen in order to start the measurement.
5. Open port of Swan-Ganz catheter and inject injection solution with continuous fast pusher
movement after the third short acoustic signal generated by a monitor.
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6. Wait for the measurement completing (about 30 seconds) and read the result.
7. Wait for readiness for next measurement signaled by a message “Ready for new
measurement” displayed over the temperature graph of the previous measurement and
press “Start CO” button in order to start the next measurement.

Fig. 6.40

Change the screen for a cardiac output measurement


In the mode dropdown list you will find three types of screen modes:
 Monitoring:
This is the default monitoring screen
 Measurement:
This mode will change the live screen for making a cardiac output measurement
 Measurement review:
This mode will change the live screen for reviewing the cardiac output measurements that
were made

Select a cardiac output catheter


In the catheter dropdown list you can select the catheter you will be using during your cardiac output
measurement. This list is a predefined list

Start and stop a cardiac output measurement


To start a CO measurement; press ‘Start CO’
To stop/cancel a CO measurement; press ‘Cancel CO’

Select/deselect a CO measurement
When a measurement is performed, the results will show on the live screen and in the table on your
control screen (also in the cardiac output box). Under the column ‘Use’ you can select and deselect
the measurements you want to use. These measurements will be taken into calculations

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6.12.2.3 The Computation Constant (CC)
The Computation Constant is a specific value used for CO calculation. It is related with a type of the
Swan-Ganz Thermodilution catheter as well as temperature and the volume of injection solution
delivered during individual measurement.
WARNING!
In order to properly compute the Cardiac Output value it is necessary to use an appropriate
CC value which depends on type of used catheter and measurement conditions. The improper CC
value causes a fundamental error in CO value estimation and consequentially in the CI value.

CAUTION:
The CC value must be introduced before starting a new measurement session.

It is possible to change the CC value during the currently performed measurement session. However
the user should remember that every CC value is chosen taking into consideration specific condition
of the Cardiac Output measurement (type of Swan-Ganz catheter, volume and temperature of the
injection solution).

That is why changing of the CC value means that the condition of the Cardiac Output measurement
has been changed. In such a situation, the previous measurement in a session will be not correctly
computed comparing to the new measurements that will be performed after changing the CC value.
WARNING!
It is necessary to delete previous measurements, if the CC value has been changed during one
measurement session. Then the user may continue the session.

6.12.3 CO module messages


The following messages can be displayed at the monitor’s screen during the CO monitoring:
CO module init in progress Displayed after switching on the monitor, when a connection with the
CO module and a system is being started. Usually the message
disappears a few seconds after a mainscreen displaying. If the
message is displayed for a longer time and does not disappear,the
module could become damaged and Fysicon Support should be
contacted.

Ready for new The module is ready to begin with the next individual CO
measurement measurement

Inject now The command (followed by a sound signal) for the start of the
injection of the injectate.

Wait The command of suspension of the module until it is ready for


activity.

Wait for new measurement The command of suspension of the module until finishing the
measurement and readiness for the beginning of the next one.

Too late injection The information that the injection of the solution (injectate) has
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begun too late – incorrect measurement.

Too quick curve drop The information about the incorrect shape of the blood temperature
changes during the measurement – incorrect measurement.

Too short measurement The information about too little time of measurement (the changes of
temperature after delivery of the injectate did not reduce within the
measurement time provided for the measurement – incorrect
measurement.

No CO module Displayed when the module is not connected to the monitor.

No communication to CO Displayed when there is no communication to the CO module after


module the module initialization.

6.12.4 CO module alarms

Tblood out of range The patient’s blood temperature is out of the range accepted fro CO
measurement. The accepted range of patient blood temperature
varies from 30oC - 40oC.

Tinj out of range The temperature of the injectate (solution) is out of range accepted
for CO measurement. The accepted range for the injectate varies
from -1oC - +30oC.

CO alert The COI value is out of the accepted range. The borders of alert
available for CO value are varied from 0 – 20 l/min.

CI alert The CI value is out of the accepted range. The borders of alert
available for CI value are varied from 0 – 20 l/min.

6.12.5 Cleaning and disinfecting accessories

6.12.5.1 CO cable and reference probe


Cleaning: The interface cable and plugs should be kept clean using hand-warm soapy water or a
neutral cleaner.

Disinfection:Use chemical disinfectants containing ethanol (70% - 80%), propanol (70% - 80%) or
aldehydes (2% - 4%).

6.12.5.2 Disposing Swan-Ganz catheters:


Used Swan-Ganz catheters should be disposed of in accordance with local regulations for biologically
hazardous materials.

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CAUTION:
Never immerse plugs and/or cables into any liquid.
Never expose cables to strong ultra-violet radiation.
Before using cables and plugs, carefully check that they show no damage or abnormality and that
they are perfectly clean.

6.12.6 Accessories and ordering information


Choosing an improper size of accessories may cause incorrect results of measurements. All necessary
accessoriescan be ordered at Fysicon. Please write the name of the accessory and information about
the intended in case you don’t know the re-order number.

ATTENTION:
The serial number of the monitor should be included in the order.

Below mentioned you will find the available probes and accessories. The items marked with an
asterisk * are supplied with the CO module.

014240600 * CO Y-Cable w. Jackplug (2,5 mtr)

014240601 CO Y-cable

014240602 Long CO cable

9850A Bath Probe assembly

QynetiQ™s CO module will co-operate with all Swan-Ganz catheters dedicated to thermo-dilution
measurements, compatible regarding electric features with catheters AHSC / Baxter (Rth: 14 kΩ ,
sensitivity: 510,52 Ω/ºC);

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6.13 Vitals

Fig. 6.41

Chart vitals (once) manually


To chart vitals (once) manually, press the ‘Manual Snapshot’ button. To include NIBP in this single
chart, press the ‘Include NIBP’ button on the top of the box, before to press ‘Manual Snapshot’.

Set an interval for charting the vital signs


Unfold the vital box by clicking the arrow in the middle. From here you can set the interval for
charting the vital signs (for example every 5 minutes). Click start to start charting in (for example) 5
minutes. A message will be displayed underneath the “Auto vital charting” button with the
approximate time remaining until the next measurement. This message is also displayed on the live
screen. To stop charting at a set interval, press stop.

Include NIBP in the automatic vital charts


By default, NIBP will not be included when the vital signs are charted. If it is wished to include NIBP,
press the ‘Include NIBP’ button on the bottom of the box.

Where to find the vital charts


When the vitals are charted, you will find them in the ‘Event log’ page. This page is located in the
tabs list:

Fig. 6.42

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6.14 Samples
There are two different ways to create a sample, via:
 QynetiQ™ toolbar (always possible)
 The procedure control page (only possible when you are actually in the procedure control
page)

Create a sample
On top of the QynetiQ™ control screen you will find the QynetiQ™ toolbar:

Fig. 6.43
With these buttons you can create a sample (even while you’re filling in a report, because these
buttons are always available). When you press the QynetiQ™ button you will find more sample types:

Fig. 6.44

Choose the type of sample you want to make and then press the button. In the right bottom corner
of your control screen messages will appear:
 Creating a sample…
 Sample created successfully and ready to be viewed

The sample is now created and ready to be viewed in the sample review page (see chapter 7. Sample
review)

Create a sample (from the procedure control page)


It is also possible to create a sample from the procedure control page:

Fig. 6.45

Choose the type of sample you want to make and then press the button. In the right bottom corner
of your control screen messages will appear:
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 Creating a sample…
 Sample created successfully and ready to be viewed

The sample is now created and ready to be viewed in the sample review page (see chapter 7. Sample
review)

Creating a pullback sample


When you want to make a pullback sample, it is necessary to give in some extra information. When
you press pullback, a window will popup:

Fig. 6.46

Select which channel, and the source and destination. When you filled in all three, press OK. The
sample will now be created

Averaged samples
When the user creates a Pullback, Gradient or Merge sample, the medical specialist may find it
necessary to manipulate the average view of the sample for a more accurate calculation of the
gradient and/or valve areas.

In previous versions of our software (v1.5 and earlier), it was only possible to manipulate the full
view of these sample types, because any manipulations in the average view cannot be calculated
back to the original sample values. To make it possible for the user to manipulate the average view
of the samples, changes have been made in the new software version (v1.6) to produce two (2)
separate samples whenever a Pullback, Gradient or Merge sample is created and/or re-analyzed: a
full view sample and an average view sample. The table below lists the types of samples that
represent the full view and average view:

Action Full view sample type Average view sample type


Pullback sample Pullback Superimposed
Gradient sample Gradient Calculated Avg (Gradient)
Merge sample Merge Calculated Avg (Merge)

This document contains information about the changes implemented in the new software version,
and how the changes apply to each different sample type.

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Pullback sample

1. When the user requests a new Pullback sample, the system will produce two (2) samples:

 Full view Pullback sample (named P1); and


 Averaged view Superimposed sample (named P2).

2. When the P1 sample is selected, a full view of the sample is displayed.


3. When the P2 sample is selected, a superimposed view of the sample is displayed.
4. For samples P1 and P2, the “View type” list contains only the entries “Full” and “Superimpose”.

 When the entry “Full” is selected from the list, sample P1 is automatically selected and
displayed.
 When the entry “Superimpose” is selected from the list, sample P2 is automatically selected
and displayed.

5. Please take note of this important point concerning re-analysis of these samples:
Re-analyze automatically updates

Re-analyze does NOT update

x
 When a P1 sample is re-analyzed, a new version of the associated P2 sample is automatically
created. This is important as previous changes in the P2 sample will be overwritten.The user
must be advised to complete all manipulations of the P1 sample before manipulating the P2
sample
 When a P2 sample is re-analyzed, the P1 sample is NOT updated because it is NOT possible to
calculate changes back to the original data.
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6. When viewing a P2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. P1

7. When viewing a P2 sample, only IBP1 and IBP2 channels are visible because the data represents
the superimposed view of a P1 (Pullback) sample.

8. Toolbox features disabled when viewing a P2 sample:

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Feature Comments
Cardiac cycle disable/enable It is not possible to enable/disable cardiac cycles, because the
P2 sample represents the superimposed view of a P1 (Pullback)
sample which is a single cardiac cycle. To enable/disable
cardiac cycles, the user must go to the original full view sample,
i.e. P1
Move single marker No IBP markers are shown, because the P2 sample represents
Move ALL markers the superimposed view of a P1 (Pullback) sample. To move
markers on the IBP wave, the user must go to the original full
view sample, i.e. P1.
Merge samples The merge feature has also been disabled, because it can only
be used to merge samples containing original recorded data. A
P2 sample is a derived sample from the original P1 sample.

9. Toolbox features enabled when viewing a P2 sample:

Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the superimposed
view. During a re-analysis the gradient will be recalculated as
well as the subsequent valve calculations based on the
gradient.Note that it will only be possible to move the second
wave– the first wave must remain fixed, but the second wave
can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Superimposed
(P2) sample – see next point for details

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10. Select/deselect gradient areas:
This is a new toolbox feature that has been implemented for the Superimposed (P2) sample.
Note that this feature is only enabled when there are multiple gradient areas available (i.e. more
than 1).

Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.

Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.

When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.

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Gradient sample

1. When the user requests a new Gradient sample, the system will produce two (2) samples:

 Full view Gradient sample (named G1); and


 Averaged view Gradient sample (named G2).

2. When the G1 sample is selected, a full view of the sample is displayed.


3. When the G2 sample is selected, a calculated average view of the sample is displayed.
4. When viewinga G1 sample, the “View type” list contains the entries “Full”, “Average” and
“Calculated avg”.

When viewing a G2 sample, the “View type” list contains only the entries “Full” and “Calculated
avg”.

 When the entry “Full” is selected from the list, sample G1 is automatically selected and
displayed.
 When the entry “Calculated avg” is selected from the list, sample G2 is automatically
selected and displayed.

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5. Please take note of this important point concerning re-analysis of these samples:
Re-analyze automatically updates

Re-analyze does NOT update

X
 When a G1 sample is re-analyzed, a new version of the associated G2 sample is automatically
created. This is important as previous changes in the G2 sample will be overwritten. The
user must be advised to complete all manipulations of the G1 sample before manipulating
the G2 sample
 When a G2 sample is re-analyzed, the G1 sample is NOT updated because it is NOT possible
to calculate changes back to the original data.

6. When viewing a G2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. G1

7. Toolbox features disabled when viewing a G2 sample:

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Feature Comments
Cardiac cycle disable/enable It is not possible to enable/disable cardiac cycles, because the
G2 sample represents the calculated average view of a G1
(Gradient) sample which is a single cardiac cycle. To
enable/disable cardiac cycles, the user must go to the original
full view sample, i.e. G1
Move single marker No IBP markers are shown, because the G2 sample represents
Move ALL markers the calculated average view of a G1 (Gradient) sample. To
move markers on the IBP wave, the user must go to the original
full view sample, i.e. G1.
Merge samples The merge feature has also been disabled, because it can only
be used to merge samples containing original recorded data. A
G2 sample is a derived sample from the original G1 sample.

8. Toolbox features enabled when viewing a G2 sample:

Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the calculated
average view. During a re-analysis the gradient will be
recalculated as well as the subsequent valve calculations
based on the gradient.Note that it will only be possible to
move the second wave– the first wave must remain fixed, but
the second wave can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Calculated
average (G2) sample – see next point for details

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9. Select/deselect gradient areas:
This is a new toolbox feature that has been implemented for the Calculated average (G2) sample.
Note that this feature is only enabled when there are multiple gradient areas available (i.e. more
than 1).

Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.

Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.

When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.

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Merge sample

1. When the user uses the wizard to create a new Merge sample, the system will produce two (2)
samples:

 Full view Merge sample (named M1); and


 Averaged view Merge sample (named M2).

2. When the M1 sample is selected, a full view of the sample is displayed.


3. When the M2 sample is selected, a calculated average view of the sample is displayed.
4. When viewinga M1 sample, the “View type” list contains the entries “Full”, “Average” and
“Calculated avg”.

When viewing a M2 sample, the “View type” list contains only the entries “Full” and “Calculated
avg”.

 When the entry “Full” is selected from the list, sample M1 is automatically selected and
displayed.
 When the entry “Calculated avg” is selected from the list, sample M2 is automatically
selected and displayed.

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5. Please take note of this important point concerning re-analysis of these samples:
Re-analyze automatically updates

Re-analyze does NOT update

X
 When a M1 sample is re-analyzed, a new version of the associated M2 sample is
automatically created. This is important as previous changes in the M2 sample will be
overwritten. The user must be advised to complete all manipulations of the M1 sample
before manipulating the M2 sample
 When a M2 sample is re-analyzed, the M1 sample is NOT updated because it is NOT possible
to calculate changes back to the original data.

6. When viewing a M2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. M1

7. Toolbox features disabled when viewing a M2 sample:

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Feature Comments
Cardiac cycle disable/enable It is not possible to enable/disable cardiac cycles, because the
M2 sample represents the calculated average view of a M1
(Merge) sample which is a single cardiac cycle. To
enable/disable cardiac cycles, the user must go to the original
full view sample, i.e. M1
Move single marker No IBP markers are shown, because the M2 sample represents
Move ALL markers the calculated average view of a M1 (Merge) sample. To move
markers on the IBP wave, the user must go to the original full
view sample, i.e. M1.
Merge samples The merge feature has also been disabled, because it can only
be used to merge samples containing original recorded data. A
M2 sample is a derived sample from the original M1 sample.

8. Toolbox features enabled when viewing a M2 sample:

Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the calculated
average view. During a re-analysis the gradient will be
recalculated as well as the subsequent valve calculations
based on the gradient.Note that it will only be possible to
move the second wave– the first wave must remain fixed, but
the second wave can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Calculated
average (M2) sample – see next point for details

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9. Select/deselect gradient areas:
This is a new toolbox feature that has been implemented for the Calculated average (M2)
sample. Note that this feature is only enabled when there are multiple gradient areas available
(i.e. more than 1).

Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.

Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.

When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.

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6.15 ST analysis
6.15.1 Module description
The QynetiQ™monitorshave the possibility to perform ST parameters measurement for currently
measured ECG leads. Measurements could be made using averaged QRS complexes, which are visible
in the ST measuring window. ST analysis is disabled after switching on the monitor and it should be
enabled in the ECG menu.

Two parameters are measured during the analysis: level, slope and they are labeled as follows:

 STL1, STL2, etc – ST level in channels,


 STS1, STS2, etc – ST slope in channels.

Fig. 6.47 Fig. 6.48

Measurements are made automatically basing on the average QRS complex and chosen measuring
points:

 IZO – isoline level measuring point,


 ST1 – J point of ST slope,
 ST2 – ST level and slope measuring point.
These points are visible as dots on the averaged QRS complex. The measuring points are shown on
the figure 6.47.

6.15.2 Using ST analysis


In order to start ST monitoring the user should:
1. Follow the instructions described in the 6.1.2 “Using the ECG module”.
2. Turn on the ST analysis in the ST Menu.
3. Select in the ST Menu, if the averaged QRS complex should be displayed on the left side of
the wave.
4. In the ST Menu choose the number of leads, and which leads should be analyzed.
5. Check the standard settings of the measuring points. If they are not in a proper position, the
user should change the position using going into the “Measuring points” submenu in ST
Menu. There the averaged QRS complex with the marked measuring points will be displayed
with a possibility to change the IZO, ST1 and ST2 points. Standard distances between the
points are:

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 IZO = R - 80 ms,
 ST1 (J) = R + 40 ms,
 ST2 = R +120 ms.

ATTENTION:
The measuring points' placement depends on the morphology of the ECG waveform. To get the
reliable results the placement should be verified and corrected (if necessary). Every change of the
ECG amplitude begins the formation of a new average QRS complex model.

6. Set the alarm limits: ST level and slope.


7. Choose the correct screen configuration if the used one is not sufficient.

CAUTION:
Note that the measuring points are placed in standard positions but in some Holter systems, placing
of these points is different. In addition, for different ECG signal morphology, measuring points may
be changed and that is why the medical personnel should verify them. Default placing of the
measuring points may be changed in the ST menu.

There is a time required for averaging the QRS complex after enabling the ST analysis. The average
QRS complex is displayed on the left side of the ECG waveform.

Usually the averaging time is 10-20 seconds (depending on a current patient’s heart rate). During
this time, only the QRS complexes of the same class are analyzed in order to prepare an average QRS
complex. This adaptation process is started from the beginning, whenever the amplification of the
ECG waveform is changed.

6.15.3 ST analysis module settings

Fig. 6.49

ST analysis on/off: Turning the arrhythmia analysis module on or off. The


analysis is turned off after switching the monitor. Default setting: Off.

6.15.4 ST analysis module messages


The following messages can be displayed at the monitor’s screen during the ST analysis:
ST analysis init in progress Displayed when connection with the ECG module is being initialized.
It disappears a few seconds after the main monitor’s screen is
displayed. If the message is still displayed, it means the module could
be broken or damaged. In this situation please contact Fysicon
Support.

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ECG cable unplugged Displayed when the ECG cable is not connected to the monitor.

Bad contact of electrodes Displayed when an electrode or electrodes is either not adhered
properlyor has a badcontact with the patient’s chest.

No ST analysis module Displayed when the ECG module is not connected to the monitor.
No communication to Displayed when there is no communication to the ECG module after
ST analysis module the moduleinitialization.

ST analysis off Displayed, when the ST analysis is not enabled.

6.15.5 Maintenance and cleaning


The information about maintenance and cleaning of accessories used for the arrhythmia analysis is
described in 6.1.5 concerning the ECG module.

6.15.6 Accessories and ordering information


Accessories used for arrhythmia monitoring are the same as used for the ECG module. See 6.1.6.

6.16 FFR
6.16.1 Module description
The Fractional Flow Reserve (FFR) module works in conjunction with the IBP module. The FFR module
will calculate the ratio between maximal myocardial flow in a stenotic vessel and maximal myocardial
flow in the same vessel without stenosis. It accomplishes this by using data generated by two IBP
channels.

6.16.2 Using the FFR module

6.16.2.1 Preparing the module


The pressure channel before the stenosis (label Pa) and the pressure channel behind the stenosis
(label Pd) need to be declared in order for the FFR module to work properly. These channels can be
defined in the procedure control tab under the FFR menu.

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Fig. 6.50
The location of the FFR measurement can also be defined, but is not mandatory.
Once the channels are defined, the FFR measurement can be started. This can be done in four
different ways: Manually, automatically, in the full disclosure tab and through the shortcut on the
QynetiQ™ Toolbar.

Fig. 6.51

6.16.2.2 Manual FFR measurement


A manual FFR measurement can be started by pressing the “Start FFR” button in the FFR menu. Both
channels can be zeroed at the same time by pressing the “Zero transducers (all channels)” button if
necessary. A minimum of seven seconds is required for a FFR sample. The actual FFR ratio is
calculated after starting the measurement. The button “FFR sample” also becomes available. This
button triggers the creation of an FFR sample, which can be viewed in the Sample Review tab. The
FFR measurement can be stopped by pressing the “Stop FFR” button.

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Fig. 6.52

6.16.2.3 Automatic FFR measurement


By pressing the “Auto FFR” button in the FFR menu, will analyze a set amount of time (the default is
60 seconds) and will created a FFR sample based on the smallest ratio in that period.

Fig. 6.53

6.16.2.4 QynetiQ™ Toolbar


The QynetiQ shortcut in the QynetiQ™ Toolbar also has the option of triggering the creation of a FFR
sample.

Fig. 6.54

6.16.2.5 FFR through the full disclosure


An FFR sample can be taken through the full disclosure tab in the same way as the other types of
samples. (See chapter 8 for more information)
During an active procedure the FFR sample should be analyzed right away, if the Pa and Pd channels
were defined correctly.

However, if a FFR sample is taken in the full disclosure of a non-active procedure, the initial analysis
of the sample will fail. The sample itself will be created and can be viewed in the sample review tab.
To get a correct analysis the newly created sample will need to be reanalyzed. This is done by
selecting the sample in the sample review tab and opening the settings menu at the left side of the
screen. Select the two appropriate IBP channels and change their labels to Pa and Pd. Now press the
“Reanalyze” button in the quick access toolbar. The new FFR values will be displayed in the sample.

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Fig. 6.55

Fig. 6.56

(More information regarding the sample review tab and the reanalyze function can be found in
chapter 7)

6.16.3 Reviewing FFR results


The FFR results can be reviewed in the sample review tab (See chapter 7).

6.17 Generating a report

Generate a report
When you finished your procedure, it is possible to create a report. To do, choose the type of report
you want to generate and then press that button in the reports toolbar:

Fig. 6.58

In the toolbar there will be a few shortcuts. To see more type of reports, press ‘Report all’. When you
chosen a type of report, that report will be opened in Microsoft Word©.

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7. Sample review

The sample review page can be viewed during an active procedure and when a previous performed
procedure is opened. During a review of a previous performed procedure, the sample review page
will show automatically when you opened the monitoring tab (the procedure control page is then not
available). If not, you can switch tabs by clicking them. When a page is opened, the name of the tab
will become blue:

Fig. 7.01

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7.1 Viewing the samples you created

7.1.1 Open a sample


The samples you created can be found in the thumbnail bar. To open the thumbnail bar, press
‘Thumbnails’:

Fig. 7.02
Select the sample you want to view by clicking on the thumbnail

7.1.2 Opening the settings menu


To open the settings menu of the sample review page, press ‘settings’ (on the left side of the sample
review page, a vertical button). The settings menu will open. The ECG and IBP settings boxes will
open by default.

Fig. 7.03

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Fig. 7.04
In the settings menu you will find:
 Reanalyze function
 Save function
 Undo function
 Delete function
 Print sample function
 Print ECG function

 ECG settings (5.4.2.3)


 IBP settings (5.4.2.4)
 SpO2, Respiration settings (5.4.2.5)
 Other settings (5.4.2.6)
 Toolbox (5.4.2.7)

To open a settings box, press the arrows on the left of the title:

Fig. 7.05

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7.1.2.1 ECG settings

Fig. 7.06
Selecting/deselecting ECG channels
A highlighted button means that that ECG channel is selected and shown on the sample. Click the
button to select a channel. V1 –V6 can get a different name, choose the name from the dropdown
list.

Change the color of the ECG leads


Choose a color from the color dropdown list

Change the style of the ECG display


Choose a style from the style dropdown list

Change the sensitivity of the ECG


Choose the desired sensitivity from the dropdown list

Change the lead from which the heart rate is taken


Select lead I, II or III by checking the box under ‘lead’

Fig. 7.07
When you changed the lead and want to reanalyze the sample, press ‘Reanalyze’ on top of the
settings menu.

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7.1.2.2 IBP settings

Fig. 7.08
Change the label of an IBP channel (pressure wave)
To change the label of an IBP wave, choose the correct label from the dropdown list (under ‘label’)

Select/deselect an IBP channel (pressure wave)


Select or deselect an IBP channel by clicking the channel button

Display mean
To display the mean of a pressure on the sample, select the box under ‘mean’. When you deselect
the box again, the mean will no longer be visible on the sample

Fig. 7.09

Change the upper scale


To change the upper scale of the sample, choose the value from the dropdown list under ‘upper’

Change the color of an IBP channel (pressure wave)


To change the color, pick the color from the dropdown list under ‘color’

7.1.2.3 SpO2 and respiration settings

Fig. 7.10

Select/deselect SpO2 or Respiration


Select or deselect an IBP channel by clicking the channel button

Change the color of the Spo2 or Respiration wave


To change the color, pick the color from the dropdown list under ‘color’
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7.1.2.4 Other settings

Fig. 7.11

Change the sweep speed


Change the sweep speed by selecting the sweep speed from the dropdown list

Add IBP time line


To add IBP time lines, select from the dropdown list:

Fig. 7.12

Change the view type of the sample


It is possible to have a full view of the sample, an average view or a superimpose view. Select to type
of view you want from the dropdown list

7.1.2.5 Toolbox

With these buttons you can:


- Move an ECG wave (up/down)
- Move an IBP wave (left/right)
- Disable/enable a cardiac cycle
- Move a single marker
- Move all markers
- Move pullback segment divider
- Merge samples

If you changed any of the above, it is necessary to reanalyze the sample. To do; press ‘Reanalyze’, on
top of the settings menu.

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Fig. 7.13

You will find the below mentioned options on top of the settings menu:

Reanalyze a sample
Reanalyze a sample by pressing ‘reanalyze’

Save a sample
Save a sample after you changed something by pressing ‘Save sample’

Undo your last change


Undo the last change you made on a sample by pressing ‘Undo last change’

Delete a sample
Delete a sample by selecting the sample and pressing ‘Delete sample’

Print sample
Print the selected sample by pressing ‘Print sample’

Print ECG
Print the ECG by pressing ‘Print ECG’. Then choose the print format:

Fig. 7.14

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8. Full disclosure
The full disclosure page can be viewed during an active procedure and when a previous performed
procedure is opened. To open the full disclosure page, press the tab in the monitoring page.During a
review of a previous performed procedure, the procedure control page is not available.When a page
is opened, the name of the tab will become blue:

Fig. 8.01

8.1 Full disclosure settings menu


To open the settings menu of the full disclosure page, press ‘settings’ (on the left side of the full
disclosure page, a vertical button). The settings menu will open:

Fig. 8.02

Change the displayed channel


To change the channel that is displayed on the full disclosure, choose the channel from the
dropdown list:

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Fig. 8.03
If you changed the channel (to for example IBP1), it is necessary to refresh the full disclosure. A
message will warn you:

Fig. 8.04

Change the size


You can change the size by choosing the size from the dropdown list. You must refresh afterwards

Edit the seconds per line


To change the amount of seconds per line, choose the seconds from the dropdown list. You must
refresh afterwards.

Refresh the full disclosure


To refresh the full disclosure, after you made a change, press the ‘Refresh Full Disclosure’ button

8.1.2 Making samples from the full disclosure

Making a sample from the full disclosure


To make a sample from the full disclosure, select the place where you want to make a sample by
clicking on it. A window will pop up:

Fig. 8.05

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On the button of the green window there are some buttons. Choose the sample you want to make
and click that button (for normal sample, press normal sample etc.) In the right bottom corner of
your control screen messages will appear:

 Creating a sample…
 Sample created successfully and ready to be viewed

The sample is now created and ready to be viewed in the sample review page (see chapter 5.4.2
Sample review)
When you created a sample, the place where you made the sample will be highlighted in blue now.
When you hover over that highlighted area, the sample data will be shown.

Create a pullback sample from the full disclosure


To create a pullback sample from the full disclosure, select the IBP channel on which the catheter
was connected from the channel dropdown list (this will normally be IBP1). Click refresh. Search for
the moment where (for example) the LV wave changed to an AO wave. Click on that segment. A
green pop up window will show (as explaned above). Press ‘Pullback’. A new window will come up:

Fig. 8.06

Select which channel, and the source and destination. When you filled in all three, press OK. The
sample will now be created.

Finding a marker you made during a procedure


When you placed a marker during a procedure, you can find this back in the full disclosure. The
marker will be displayed as a blue arrow.

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9. Alarms
Every monitored parameter (ECG, NIBP, SpO2 etc.) is supervised by a 3-level medical and technical
alarm system:

1-level alarm – alarms with the highest priority, which informs about a necessity of an immediate
action of the medical personnel (blinking red color).
2-level alarm – alarms with the medium priority, which informs about a necessity of a prompt action
of the medical personnel (blinking yellow color).
3-level alarm – alarms with the lowest priority, which informs about events of low importance or
only about patient’s discomfort (cyan color).

Description of all alarm groups are shown in the tables on the next pages.

WARNING!
Acoustic signaling of medical alarms may not be completely silenced in Menu Speaker.
Only Heart rate acoustic signaling may be completely silenced.

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9.1 ALARM PRIORITY TABLE part 1

ECG ST ARRHYTMIA RESP


Parameter Priority Parameter Priority Parameter Priority Parameter Priority

Frequency High STL High Asystole High Rate High

INOP Medium STS High Pause High Apnea High

Cable
Low VF / VT High INOP Medium
Unplugged
No Bad contact of
Low Brady High Medium
Communication Electrodes

No Module Low Sin. Tach High

Bigeminy High

Trigeminy High

VPB Run High

R on T High

VPBs High

SVEs High

AF High

Missing Beat High

Interferences High

Irr. HR High

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9.2ALARM PRIORITY TABLE part 2

TEMP NIBP IBP SpO₂


Parameter Priority Parameter Priority Parameter Priority Parameter Priority

T1 High SP High IBPS High SpO₂ High

T2 High MAP High IBPM High PR High

Probe
∆T High DP High IBPD High Low
Off Patient
Sensor Probe Probe
High Overpressure High Low Medium
Unplugged Unplugged Unplugged
Excessive No No
No Module - Medium Low Low
Motion Communication Communication

No Cuff Medium No Module Low No Module Low

No
Low
Communication

No Module Low

EtCO₂ CO RECORDER BATTERY


Parameter Priority Parameter Priority Parameter Priority Parameter Priority

EtCO₂ High CO High No paper Medium Battery Low Medium

No
inCO₂ High CI High Low
Communication
Respiration Probe
High Low No Module Low
rate Unplugged

Apnea High No Catheter Low

Measurement
Occlusion Medium Session Low
Message
No
No Water Trap Low Low
Communication

Other Error Medium No Module Low

No
Low
Communication

No Module Low

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9.3 Medical alarms
The medical alarms are the 1st level alarms. If exceeding the alarm limits is detected than the
acoustic (a speaker inside the monitor) and visual (a red blinking field at the upper toolbar and a
numerical value of the parameter) alarm is initiated. The abbreviation of the parameter name, which
caused the alarm initiation, is written at the highlighted box (e.g. ECG, Resp, IBP2 SpO2, etc.). An
example is shown at figure 9.01

CAUTION:
TheAlarm signalization described is based on the ECG module. The remaining parameters’ alarms
operate in a similar way. A little bit different operation concerns the arrhythmia analysis where
acoustic and optical signaling of Asystole, Pause, VF/VT and Bradycardia episodes are available.

Fig. 9.01

The user should press the red field ALARM HRat the main screen in order to acknowledge the
handling of the alarm. At this moment the red field and the acoustic signaling will be disabled but
the red HR value of the parameter, will still blink red.

WARNING!
In order to acknowledge the handling of the alarm, the user should press the blinking red field at the
upper toolbar, causing the acoustic signaling to be disabled. The red blinking of a value of a
parameter, which initiated the alarm signaling, will be stopped, when a cause of the alarm is
eliminated. If the cause of the alarm is not eliminated during 2 minutes, the acoustic signaling is
activated again.

The similar rules of alarm signaling operation concern the other parameters available in the monitor
accept APNEA detection.

WARNING!
The values of alarm limits set by the user in the patient monitor are restored even after turning the
monitor off.

9.4 Medical alarms – setting the alert limits


Alarm programming may be done by going into the Menu of each module and then pressing “Alerts
limits” button or by the Alerts screen available after pressing “Alerts” button on the low toolbar next
to the “Menu” button.

The alarm screen consists of 2 tabs:

 Alert settings,
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 Alert suspension time.
 A list of available alert limits in the monitor (except Apnea time and arrhythmia levels) is
shown in the first „Alert settings” tab. The user may change the whole list of alarms by
pressing “Select” button. After pressing this button there are 5 standard lists of alert limits
available:
 List configurable by the user (“Set 1”, “Set 2”, “Set 3”),
 Preconfigured factory list of alert limits (“factory”). Cannot be edited,
 Automatic adjusted list of alert limits which are specifically set in accordance with currently
monitored parameters (“automatic”). In order to check the currently monitored parameters
and automatically set the limits the user should press “Set” button, which is available only
for this automatic list.

Every alert limit can be individually edited (except “factory” list) by pressing the field which it
concerns and then the upper or the lower value can be adjusted using “+” and “-” buttons.

After accomplishing the alert’s adjustments and choosing the list which should be currently active,
the user should press “Save” button.

In order to cancel all the changes that were currently made, the user should press “Cancel” button.

The second tab is “Alert suspension time”.

In this tab the user is able to set the time of the alerts suspension. There are two standard options; 1
or 2 minutes.

Alert settings Alert suspension time

Off
upper lower

set 1
Select

Cancel Save

Fig. 9.02

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Abbreviations of parameter’s names are explained in the table below.

Parameter Description Parameter Description


HR Heart rate measured by ECG T1 Temperature – first channel
module
SP Noninvasive systolic pressure T2 Temperature – second channel
measured by NIBP module
MAP Noninvasive mean pressure ΔT1-2 Difference between the first and
measured by NIBP module second temperature channel
DP Noninvasive diastolic pressure inGAS1** Inhaled value of anesthetic agent
measured by NIBP module measured by gas module
SpO2 Oxygen saturation measured by etGAS1** End tidal value of anesthetic agent
pulse oximeter measured by gas module
PR Pulse rate measured by pulse InN2O Inhaled value of N2O measured by
oximeter gas module
etCO2 End tidal CO2 value measured by etN2O End tidal value of N2O measured by
capnography module gas module
inCO2 Inspired CO2 value measured by inO2 Inhaled value of O2 measured by
capnography module gas module
RRCO2 Respiration rate measured by EtO2 End tidal value of O2 measured by
capnography module gas module
RR Respiration rate measured by STL1* ST segment level value calculated
respiration module by ST analysis module
IBP1S* Invasive systolic pressure measured STS1* ST slope value calculated by ST
by invasive blood pressure module analysis module
IBP1M* Invasive mean pressure measured CO Cardiac Output value
by invasive blood pressure module
IBP1D* Invasive diastolic pressure CI Cardiac Index value calculated by
measured by invasive blood Cardiac output module
pressure module
PRIBP1* Pulse rate measured by invasive
blood pressure module

* Parameter with “1” digit can be also present with digit “2” “3” or higher.

** “GAS” label is exchanged by first three letters of a name of a currently chosen anesthetic gas.

If there is no need to monitoring of one or more limits they can be turned off. Press a chosen alert
limit field and then press “Off” button. Chosen limits will not be monitored and numeric limits will be
replaced with dash. If such setting is saved, then an additional icon will be displayed in the alarm
mode field (Fig. 9.03).

Additional icon informing about


turning one or more alerts off

Fig. 9.03

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WARNING!
Automatically adjusted limits should be checked and accepted every time by a patient’s physician.
It is recommended for the user to inspect the proper work of acoustic signaling in regular intervals.
The user should go into the Main menu and choose Speaker menu. Then the “HR beeperloudness”
should be pressed. Using the “+” and “-“ buttons the proper work of the speaker may be inspected

“Apnea time” parameter available in Respiration Menu, CO2 Menu, O2 Menu, Gas Menu is not
present in the list of alerts. In order to change the Apnea time the user should go into one of the
Menus mentioned above. The “Apnea time” can be set between 5 and 60 seconds or apnea
monitoring may be disabled. If Apnea detection is disable then a strikethrough label “APN” is
displayed in a digital values field of the Respiration module.

9.5 Technical alarms


Technical alarms have second and third level of priority.

The second level technical alarm is signaled in an acoustic and optical way, which informs the user
about malfunctioning of a measuring circuit (e.g. an ECG electrode is not adhered to a patient,
patient’s finger has slipped off the SpO2 probe, measuring module became damaged etc.). Optical
signaling is presented as a yellow field at the upper toolbar with a text, which informs the parameter
which caused the alarm initiation (e.g. CO2, what means a failure of CO2 module). The acoustic
signalingof the technical alarm is presentedas a modulated sound.

The loudness of the technical alarm may be adjusted in the Speaker menu available in the Main
menu. Adjusting of the technical alarm loudness may be done after pressing “Alert loudness”.

The technical alarm signaling may be initiated by several reasons, which depend on the monitored
parameter.

The third level technical alarm is signaled in a visual way by displaying a cyan color field at the upper
toolbar with a text, which informs the parameter, which caused the alarm initiation. It is displayed to
inform the user about connecting the probes and cables to the monitor for the parameters installed
in the monitor.

The third level technical alarm is not signaled in an acoustic way.

Figure 9.04 shows a situation, when fields of alarms of the third (first field on the right side), the
second (first field on the left side) and the first priority level are displayed.

Fig. 9.04

WARNING!
Information about possible technical alarms is available in a chapter describing measuring

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modules.
Operation of the technical alarm must be done by acknowledging by the user of the monitor and
may be done by pressing the yellow or cyan field at the upper toolbar. The yellow or cyan field will
disappear and the acoustic signaling (for the second priority level alarm) will be disabled.If the
cause of initiation of the alarm was eliminated then a message on the screen (e.g. bad contact
of electrodes – for the ECG module) will disappear also. However it the cause is not eliminated it
will be displayed constantly.
As far as the CO2 module is concerned, a message “Read messages” may be displayed. In this
situation, the values available after pressing “Status” button in the CO2 menu (e.g. 0x08, 0x04,
0x13)should be written down and passed to the manufacturer service.

9.6 Alarm status


A field (next to a patient’s data field), which informs about a status of the alarms is visible at the
upper toolbar. There may be four statuses, available after pressing the icon, which graphical figures
are shown in a table below:

All alarms enabled.

Acoustic signaling of the alarms disabled.

All alarms temporarily disabled.

All alarms completely disabled. Additionallya blinking red field, with a


text “Alerts off”is displayed at the upper toolbar.

Alarm statuses may be changed by pressing the graphical figure until the sign, which concerns the
required status is displayed.

WARNING!
Disabling of the acoustic signalization of the alarms but especially complete disabling of all alarms
may be dangerous to a patient, because if a medical alarm should be initiated, the user of the
monitor may not be aware of a danger for the patient’s health. That is why these alarm statuses
should be set with full awareness of the medical personnel.
Setting of the alarm limits too wide may be dangerous to the monitored patient.

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10. Keyboard shortcuts
You can access the overview of the keyboard shortcuts by pressing the right mouse button on the
"green Q" in the taskbar and select Keyboard Shortcuts.

Fig. 10.1

The next pop-up will occur.

Fig. 10.2

The key combinations for these shortcuts can be changed in the management console. To do so
please contact the system administrator.

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11. Monitor shutdown

The monitor should be properly shutdown, in order to store data that is gathered in the monitors
operating memory. The user should:
 Press the “Quit” button,
 A question will be displayed in the lower toolbar „Are you sure to quit?”
 Choose the answer “Yes”.

After pressing the “Yes” button, a screen with a message “System is shutting down” will be
displayed. The user must not turn the monitor off in this moment!!! After a few seconds a black
screen with a message “You may turn off the monitor now” will be displayed and the QynetiQ™
Enterprise monitor should be switched off using the mechanical switch placed at the right side of the
monitor looking from the front of the monitor.

Fig. 10.01

WARNING!
The user may cause failures of the monitor, if the monitor is not properly shut down.

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12. Cleaning and maintenance

The monitor should be cleaned, tested and maintained in order to ensure its proper work.

The user should focus on the following matters during testing the monitor:
 Visible mechanical damages. If the mechanical damage will be found by the user, then the
damaged part must be exchanged with a new one. Maintenance and repairs should
performed only by service engineers of Fysicon or its local representative authorized by
Fysicon,
 Cables should be checked, if they are not damaged and plugs should be carefully observed, if
their pins are not broken or bend. Maintenance and repairs should performed only by
service engineers of Fysicon or its local representative authorized by Fysicon,
 Isolation of all cables should be inspected and if a cable’s isolation shield is damaged, the
cable should
be exchanged. The user should contact the Fysicon representative in this matter.

The monitor should be cleaned in regular period of times. The housing of the monitor should be
cleaned with a wet, soft cloth. Use the following liquid for cleaning:
 Water with a small quantity of soap.

The user should clean the monitor in the following order:


 Take off the power supply cord from the mains.
 Use only the cleaning agents recommended by Fysicon.
 Always use a dry cloth to wipe the device after cleaning with the wet cloth.
 Do NOT use any cleaning agents which include wax.
 Do NOT use the following cleaning agents:
- Solvents,
- Acetone,
- Cleaning agents which include alcohol,
- Betadine (Polseptol).

The housing of the monitor’s display may be cleaned and disinfected using the agents and liquids
mentioned above.

The touch screen should be cleaned and disinfected using non aggressive 70% or 90% alcohols.

WARNING!
The monitor’s surface may become mat and even damaged, if the user does not follow the
suggestions mentioned here.
Do not use any disinfecting rays (beams) for disinfection of the patient monitor because the
monitor’s housing may become damaged.

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13. Recycling information, WEEE

The monitor should be recycled at the end of its useful life.

Recycling should be made in accordance with the national and local regulations. Contact Fysicon’s
local representative for assistance.

The monitor should be cleaned and not contaminated before it is recycled.

The battery of the monitor should be disposed in accordance to local regulations concerning
dangerous materials after they are exploited. Batteries should be discharged before its disposing.

All disposable accessories of the monitor should be utilized in accordance with local hospital
regulations.

The package of the monitor should be recycled in accordance with the local regulations.

QynetiQ™ Enterprise – User Manual (Version 1.5) 115


14. Technical information

14.1 QynetiQ™Enterprise

Front-end
- Dimensions: 365 x 145 x 280 mm (without LCD display)
- Weight: 5.7 Kg
- Power supply: 20 V ± 10%
- Power consumption: < 45 VA
- Operating Temperature: 10 o – 40o C / 42 o - 104 o F
- Relative Humidity: < 85 % non condensing
- Safety Class: I, CF
- Safety requirements: MDD 93/42/EEC, EN 60601-1

Power Unit
- Dimensions: 365 x 145 x 280 mm (without LCD display)
- Weight: 11.2 Kg (without LCD display)
- Power supply: 240 V ± 10% 50/60 Hz
- Power consumption: <1100 VA
- Operating Temperature: 10 o – 40o C / 42 o - 104 o F
- Relative Humidity: < 85 % non condensing
- Safety Class: I,
- Safety requirements: MDD 93/42/EEC, EN 60601-1

14.2 12 Lead ECG Module


Fully isolated, defibrillation protected > 5 kV.
- Dimensions: 139 x 96 x 40 mm, weight 325 gram
- Channels: 12
- Leads: I, II, III, aVr, aVl, aVf, C1, C2, C3, C4, C5, C6
- Sensitivity: 2.5, 5, 10, 20, 40 mm/mV
- Sampling frequency: 300 Hz
- CMMR: > 100 dB
- HR measuring range: 15 – 300 bpm
- Filters: Monitoring 0.5 Hz – 40 Hz
Diagnostic 0.05 Hz – 100 Hz
Operation 2 Hz – 25 Hz
- Pacemaker detection: Yes
- Artifact detection: Yes
- Lead Off detection: Yes

Arrhythmia analysis
Based on the QRS Complex
- Sensitivity: 99.5%.
- Arrhythmia’s: Asystole; Pause; VF/VT; Bradycardia; STach; Bigeminy; Trigeminy;
VPC; VPC run; R on T; PSVC; AF and Missed beats.

116 QynetiQ™ Enterprise– User Manual (Version 1.4)


ST Analysis
Based on the average QRS Complex
- ST level: ± 1 mV.
- ST slope: ± 15 mV/s.

Respiration
- Channels: 1
- Measuring method: Impedance
- Sampling frequency: 50 Hz
- Parameters: Respiration rate and Apnea
- Respiration rate: 0 – 150 / min
- Apnea recognition time: 5 – 60 sec

14.3 7 Lead ECG Module


Fully isolated, defibrillation protected > 5 kV.
- Dimensions: 139 x 96 x 40 mm,weight 298 gram
- Channels: 7
- Leads: I, II, III, aVr, aVl, aVf, CX
- Sensitivity: 2.5, 5, 10, 20, 40 mm/mV
- Sampling frequency: 300 Hz
- CMMR: > 100 dB
- HR measuring range: 15 – 300 bpm
- Filters: Monitoring 0.5 Hz – 40 Hz
Diagnostic 0.05 Hz – 100 Hz
Operation 2 Hz – 25 Hz
- Pacemaker detection: Yes
- Artifact detection: Yes
- Lead Off detection: Yes

Arrhythmia analysis
Based on the QRS Complex
- Sensitivity: 99.5%.
- Arrhythmia’s: Asystole; Pause; VF/VT; Bradycardia; STach; Bigeminy; Trigeminy;
VPC; VPC run; R on T; PSVC; AF and Missed beats.

ST Analysis
Based on the average QRS Complex
- ST level: ± 1 mV.
- ST slope: ± 15 mV/s.

Respiration
- Channels: 1
- Measuring method: Impedance
- Sampling frequency: 50 Hz
- Parameters: Respiration rate and Apnea
- Respiration rate: 0 – 150 / min
- Apnea recognition time: 5 – 60 sec

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14.4 NIBP Module
- Dimensions: 139 x 96 x 40 mm, weight 328 gram
- Channels: 1
- Measuring method: CAS MAX, Oscillometric
- Measuring mode: Manual, Auto or STAT
- Parameters: SYS, MEAN, DIA and Pulse rate
- NIBP measuring range: 15 – 260 mm Hg
- PR measuring range: 30 – 240 / min

14.5 SpO2 Module


- Dimensions: 139 x 96 x 40 mm, weight242 gram
- Channels: 1
- Measuring method: Nellcor OximaxTM
- Sampling frequency: 75 Hz
- Parameters: SpO2 and Pulse Rate
- SpO2 measuring range: 0 – 100%
- PR measuring range: 20 – 300 bpm

14.6 IBP Module


- Dimensions: 139 x 96 x 40 mm, weight 305 gram
- Channels: 1, 2 up to 4
- Sampling frequency: 50 Hz
- Sensitivity: 5.0 μV/V/mmHg
- Accuracy: ± 1 mm Hg
- Parameters: SYS, MEAN, DIA and Pulse Rate
- IBP measuring range: -30 – 320 mm Hg
- AUX: 2 Channels, Fully isolated (on the front of the module)

14.7 Temperature Module


- Dimensions: 139 x 96 x 40 mm, weight 276 gram
- Channels: 2
- Sampling frequency: 1 Hz
- Parameters: Temperature
- Measuring range: 0o – 50o C / 32o – 122o F and Δ T
- Resolution: 0.1o C / 0.18o F

118 QynetiQ™ Enterprise– User Manual (Version 1.4)


14.8 Cardiac Output (CO) Module
- Dimensions: 139 x 96 x 40 mm
- Weight: 283 gram
- Channels: 1
- Measuring method: Thermodilution
- Sampling frequency: 50 Hz
- CO measuring range: 0 – 20 l/min
- T measuring range: 30o – 42o C / 86o – 107.6o F (Blood)
0o – 26o C / 32o – 78.8o F (Injectate)

14.9 CO2 Module


- Dimensions: 139 x 96 x 40 mm
- Weight: 270 gram
- Channels: 1
- Measuring method: Respironics™ Mainstream
- Sampling frequency: 100 Hz
- Measuring range: 0 – 100 mm Hg
- Respiration rate: 0 – 150 breaths/min
- Apnea recognition time: 5 – 60 sec

QynetiQ™ Enterprise – User Manual (Version 1.5) 119


15. Authorized service

Manufacturer’s service:

Fysicon B.V.
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands

Tel: + 31 412 65 33 32
Fax: + 31 412 65 33 30
www: www.fysicon.com
@: support@fysicon.com

120 QynetiQ™ Enterprise– User Manual (Version 1.4)


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QynetiQ™ Enterprise – User Manual (Version 1.5) 121


17. Contact information

For more information, please contact:

Fysicon B.V.
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands

Tel: +31 412 653333


Fax: +31 412 653330
www: www.fysicon.com
@: info@fysicon.com

122 QynetiQ™ Enterprise– User Manual (Version 1.4)

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