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iVent101 / ClevAir
Technical Reference Manual
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Released
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Owner’s Record
The model number and serial number of your iVent101 are on the rear panel of your ventilator. Record the serial number in the
space provided below to have this information should you need to call for service or support.
Model Number:
Serial Number:
Important
The information contained in this Technical Reference manual pertains only to those
models of products which are marketed by VersaMed as of the effective date of this
manual or the latest revision thereof. This Technical Reference manual was prepared for
exclusive use by VersaMed service personnel in light of their training and experience as
well as the availability to them of parts, proper tools and test equipment. Consequently,
VersaMed provides this Technical Reference manual to its customers purely as a
business convenience and for the customer's general information only without warranty
of the results with respect to any application of such information. Furthermore, because
of the wide variety of circumstances under which maintenance and repair activities may
be performed and the unique nature of each individual's own experience, capacity, and
qualifications, the fact that customer has received such information from VersaMed
does not imply in anyway that VersaMed deems said individual to be qualified to
perform any such maintenance or repair service. Moreover, it should not be assumed
that every acceptable test and safety procedure or method, precaution, tool, equipment
or device is referred to within, or that abnormal or unusual circumstances, may not
warrant or suggest different or additional procedures or requirements.
This manual is subject to periodic review, update and revision. Customers are cautioned
to obtain and consult the latest revision before undertaking any service of the
equipment. Comments and suggestions on this manual are invited from our customers.
Send your comments and suggestions to the Manager of Technical Communications,
Datex-Ohmeda, ohmeda Drive, PO Box 7550, Madison, Wisconsin 53707
CAUTION
Servicing of this product in accordance with this Technical Reference manual should
never be undertaken in the absence of proper tools, test equipment and the most
recent revision to this service manual which is clearly and thoroughly understood.
Technical Competence
The procedures described in this Technical Reference manual should be performed by
trained and authorized personnel only. Maintenance should only be undertaken by
competent individuals who have a general knowledge of and experience with devices of
this nature. No repairs should ever be undertaken or attempted by anyone not having
such qualifications.
VersaMed strongly recommends using only genuine replacement parts, manufactured
or sold by VersaMed for all repair parts replacements.
Read completely through each step in every procedure before starting the procedure;
any exceptions may result in a failure to properly and safely complete the attempted
procedure.
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Obelis S.A.
Av. de Tervuren 34, bte 44
B-1040 Brussels
Belgium
Tel: +32-2-732-59.54
Fax: +32-2-732-60.03
Manufacture Address
VersaMed Medical Systems
P.O.B. 5011, Ornat Bldg.
Hasharon Ind. Park,
Kadima 60920
Israel
Table of Contents
Table of Illustrations
Figure 1.1: The iVent101/ ClevAir (front view) 4
Figure 1.2: The iVent101/ ClevAir (rear view) 6
Figure 2.1: The power cord connected to the ventilator 22
Figure 2.2: The power cord wrapped around the handlers 23
Figure 2.3: Two limb patient circuit connected 25
Figure 2.4: One limb connection 26
Figure 2.5: Air Inlet filter 27
Figure 2.6: Low Flow O2 connector 28
Figure 2.7: Low Flow O2 connector with locking nut 28
Figure 2.8: The O2 Connector Inlet on the ventilator 28
Figure 2.9: Oxygen tubing with the connector 29
Figure 2.10: Oxygen tubing with fasten connectors 29
Figure 2.11: ClevAir Splash screen 30
Figure 2.12: iVent101 splash screen 30
Figure 2.13: Main screen 31
Figure 3.1: Pneumatic schematic diagram of two limb configuration 36
Figure 3.2: Pneumatic schematic diagram of one limb configuration 37
Figure 3.3: Pneumatic module 39
Figure 3.4: Proportional Outlet Valve (POV) 40
Figure 3.5: Inspiratory flow sensor 43
Figure 3.6: Two limb configuration – exhalation Block 45
Figure 3.7: One limb configuration – exhalation block 45
Figure 3.8: Internal exhalation valve 46
Figure 3.9: Electronic system block diagram 49
Figure 3.10: Integrated battery 51
Figure 3.11: Gas gauge interface PCB 52
Figure 3.12: Backup battery 52
Figure 3.13: Main PCB 53
Figure 4.1: The Information screen 57
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Figure 11.7. Tube Compliance Calibration Screen (One limb configuration) 216
Figure 11.8: Tube Resistance Calibration Screen (Two limb configuration) 216
Figure 11.9. Tube Resistance Calibration Screen (One limb configuration) 217
List of Tables
Table 1-1: Front panel components 5
Table 1-2: Back Panel Components 6
Table 1-3: Indicators Lights 14
Table 1-4: Upper panel symbols 15
Table 1-5: Lower panel symbols 16
Table 1-6: Back panel labeling 16
Table 1-7: Filter side icons 17
Table 1-8: Nameplate icons 18
Table 2-1: Power source icons 21
Table 6-1: Calibration Troubleshooting 123
Table 8-1: Service Notices Numbers 135
Table 8-2: System Alarms 139
Table 8-3: General Error 143
Table 9-1: Cleaning and Routine Planned Maintenance (performed by the operator)147
Table 9-2: Planned Maintenance 148
Table 10-1: Service tooling and materials 158
Table 10-2: Pneumatic unit rev. 2 tubing table 181
Table 10-3: Verification tests for new parts 197
Table 11-1: Ventilator’s System 199
Table 11-2: Main Assemblies 201
Table 11-3: Spare Parts 202
Table 11-4: Accessories 206
Table 11-5: Maintenance Kits 207
Table 11-6: iVent Software 208
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Introduction
Section 1: Introduction
The information in this manual refers both the ivent101 by
VersaMed, and ClevAir by MPV TRUMA
The information in this manual describes the service, maintenance
and test procedures for the iVent101/ ClevAir ventilator system. It is
intended to assist in maintaining the optimal functional operation
and safety of the device.
This technical reference manual should only be used by authorized
VersaMed or MPV certified technicians. Should you require further
information on becoming a VersaMed or MPV certified technician,
please contact your local VersaMed or MPV representative.
The information in this manual is not intended as a sole source of
reference and has been intended for use in conjunction with the
iVent101/ ClevAir Operators Manual. Both manuals should be
referenced when performing any maintenance to the system.
The contents of this document are not binding. If any significant
difference is found between the product and this document, please
contact VersaMed for further information. Some earlier hardware or
software versions may not be fully supported by this manual.
VersaMed reserves the right to modify the product without
amending this document or advising the user.
Introduction
Introduction
1 Exhalation exhaust
2 Proximal pressure connector
(one limb configuration only)
3 Exhalation valve connector
(one limb configuration only)
4 Inspiratory port
5 LCD touch screen
6 Activity LED
7 Battery LED
8 Alarm LED
9 Expiratory port (Two limb configuration only)
10 Air inlet filter
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9 8 7 6 5 4 3
2
10
1
11
12
14
13
Figure 1.2: The iVent101/ ClevAir (rear view)
Table 1-2: Back Panel Components
1 O2 inlet connector
2 External DC connector
3 On/ Off button
4 Remote alarm connector
5 MMC/SD memory card slot (future)
6 SpO2 connector (future)
7 LAN connector (future)
8 USB connector
9 Fuse
10 RS232 connector and cover
11 AC connector
12 AC cable strain relief
13 Power pack mounting screws
14 Power pack
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Introduction
1.4. Cautions and Warnings
Warnings and cautions appear in bold, with a sign.
VersaMed and MPV TRUMA cannot be held responsible for incidents caused
by this device unless the installation, maintenance or modification are
made by an authorized and trained person (in particular, training for
handling of products sensitive to electro-static discharge must include a
section on the use of ESD protected devices), using original spare parts and
respecting quality assurance and traceability rules approved by VersaMed
or MPV TRUMA.
The iVent101/ ClevAir should be used with a bacteria filter to protect the
patient
Take special care to ensure that liquids do not spill or seep into the
ventilator. Clean the exterior with a damp cloth only.
Close the oxygen valve on the flow meter prior to disconnecting the oxygen
from the iVent101/ ClevAir ventilator.
Do not cover the iVent101/ ClevAir ventilator while it is in use. Make sure
that the unit is positioned so that its inlet ports are open to freely
circulating air.
During infant ventilation with a high sensitivity, false triggers may occur in
certain clinical conditions. In this case, it is recommended to decrease the
sensitivity (to set its number higher).
Introduction
The iVent101/ ClevAir ventilator shall not be used with flammable agents
and flammable anesthetics.
Only medically pure oxygen should be used for operation of the device.
Anesthetics and potentially explosive gasses may not be used.
To avoid any potential fire hazard, keep all matches, lighted cigarettes
and other sources of ignition away from the device.
If you notice that the iVent101/ ClevAir is damaged in any way, its life
supporting function can no longer be guaranteed. Stop ventilation with
the defective device immediately and use an alternate form of
ventilation.
Introduction
When opening the iVent101/ ClevAir for service always exercise
appropriate ESD (electrostatic discharge) precautions. Refer to section
10.1.5: Electro-Static Discharge (ESD) Control.
1
IP 31 refers to (3) protection against tools, thick wires etc. greater than 2.5 mm (1) Degree of fluid
ingress protection provided by the enclosure (drip-proof).
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Introduction
*The iVent101/ ClevAir with the Two limb configuration complies
with the requirements of ISO 10651-2: 2004.
** The iVent101/ ClevAir with the One limb configuration complies
with the requirements of ISO 10651-6: 2004.
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Activity Green
Battery Yellow: Charging
Yellow blinking: slow charge or the battery in cool-
down mode
Blue: In conjunction with the battery status
indicators (see Understanding the Power Sources,
page 20) indicates charging completion.
Alarm Red
Introduction
On/Off Light
Introduction
1.8.4. Nameplate
The nameplate is attached underneath the ventilator and contains
the following symbols and information:
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Ventilator Name
Ivent101 or ClevAir
Manufacturer:
VersaMed or
MPV TRUMA
Date of manufacturing
Barcode
S/N
Read this book prior to
use.
CSA/UL
CE Mark
2
IP 31 refers to (3) protection against tools, thick wires etc. greater than 2.5 mm (1) Degree of fluid
ingress protection provided by the enclosure (drip-proof).
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Introduction
After powering up the ventilator for the first time charge the ventilator
3. Plug the other end of the cord into a wall outlet. The Battery Charging
LED should light up.
The battery is charged only if the integrated battery is
connected, the ventilator is plugged into external power source,
and the yellow LED is light. If the ventilator is plugged in and the
Battery Charging LED is not lit, verify the connection to both the
ventilator and the electrical outlet.
Blinking yellow light indicates that the ventilator is in slow
charge mode, due to high ambient or battery temperatures. If
the light blinks in standard ambient temperatures (less than
30°C) when the battery is cool, it may indicate a battery or
charger malfunction.
Note: If the light continues to blink for more than 3 hours in standard
ambient temperature (less than 30ºC) the battery may have
been heated by the ventilator operation. Replace the battery
and let it cool for two hours before attempting to recharge
again.
For a list of possible Battery charging LED, refer to section 1.7:
Lights.
Note: While operating, keep the ventilator plugged in whenever
possible.
Note: When not connected, wrap the power cord around the
battery screws on the back panel, as shown in Figure 2.2.
Note: When the ventilator is not in use for over a month it is
recommended to disconnect the battery and store it separately from
the device.
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Disposable one limb and two limb patient circuits are intended for a
single patient use only.
Reusable one limb and two limb patient circuits should be handled
according to their manufacturer’s specifications.
The patient circuit has to be inspected every day to:
Make sure there are no cracks or holes in the hose.
Be certain that all the connections are secure and free from leaks.
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When the patient circuit type is changed (from an adult circuit to a pediatric
and vice versa), patient circuit compensation must be performed prior to
using the new patient circuit.
Before connecting the patient to the ventilator with a new patient circuit,
you must perform a complete Ventilation Circuit Test. To perform the test,
refer to section 5.1: Patient Tube Testing Procedure.
Note: The air inlet filter must be replaced for every 1 month of
operation.
Verify that the air inlet filter is firmly attached by turning all the way
clockwise.
To replace the Air Inlet filter refer to section 10.3.1: Inlet Filter
Replacement.
Figure 2.6: Low Flow O2 connector Figure 2.7: Low Flow O2 connector with
locking nut
Verify that oxygen source is closed and that there is no pressure in the
tube prior to connecting the oxygen tubing to the ventilator.
Theory of Operation
Theory of Operation
Theory of Operation
Flow Sensor
Sample Lines
Flow Sensor &
Check Valve
Turbine
Proportional
Assembly
Outlet Valve
High Pressure
Box
Pneumatic
Enclosure
As shown in Figure 3.4, the POV acts as a flapper or gate valve, operating
between two outlet ports. The main outlet port opens into the high
pressure box and onward to the patient system. The second outlet port
opens the high pressure box allowing it to vent into the pneumatic
enclosure.
The position of the valve can be adjusted using a high reliability stepper
motor. The effective range of movement that the valve goes through is
approximately 90 degrees, and with an actuation speed, from fully open
to closed, of approximately 50ms.
In the open position the valve allows almost unrestricted flow to pass
from the turbine to the high-pressure box. In the fully closed position
the turbine flow is fully restricted, and the pressure within the high-
pressure box is release to the PU ambient through the bypass port.
The proportional outlet valve design also incorporates an optical sensor.
An interrupter is mounted to the shaft of the motor matching the size
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Theory of Operation
and position of the valve’s flapper. The optical sensor is used during the
POV calibration to confirm the extent of the flapper’s movement, and
during operation as a basis for controlling the flapper’s movement and
position.
Theory of Operation
One Way
Valve
Strut Area
Theory of Operation
Theory of Operation
3.2.13. Oxygen Supply
The iVent101/ ClevAir can be configured to enable supplemental oxygen
to be introduced to the gas destined for the patient. The system requires
oxygen from a regulated low pressure source such as flow meter or
oxygen concentrator. The oxygen flow is introduced through the
connector on the rear panel of the device (refer to
Figure 1.2) and feeds directly into the pneumatic module enclosure,
which serves as an oxygen reservoir. Accumulated oxygen is then drawn
by inspiratory pneumatics and on to the patient circuit.
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Theory of Operation
If the On/ Off switch is pressed for a prolonged period (more than 25
seconds), the system shuts down immediately. This facilitates an
emergency shutdown in the event there is no response from the touch
screen.
Theory of Operation
Integrated batteries and gas gauges are replaced as single field replacement
units, independent replacement should not be attempted.
Note: The maximum run time listed is based on a new fully charged
battery, in optimal condition and running under nominal ventilation
settings.
Figure 3.11: Gas gauge interface PCB Figure 3.12: Backup battery
Theory of Operation
3.3.8. Main PCB
The Main PCB provides the vast majority of the functions fundamental
to the operation of the device. The following primary system functions
are performed by the Main PCB:
Ventilation control and GUI: OMAP
HW control: FPGA
Power Management System
Watchdog
ADC (Analog Digital Converter)
Flow and Pressure Transducers
External Interfaces
Theory of Operation
1. Tap the Information ( ) button, located on the lower left side of the
screen.
2. Tap the left and right icons to change the brightness level. The slider
displays the brightness level accordingly.
3. Tap Accept all to save the settings and close the screen.
You can enable the flip screen option to allow viewing the iVent screen even
when the iVent is placed on the rear panel.
To enable Flip screen option
1. In the General Configuration screen tap enable and verify the green
indicator moved to enable
2. Tap Accept all to save the settings and close the screen
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2. Tap the up or down arrows on each slider to change the sound level. The
slider displays the changed sound level accordingly.
3. Tap Accept to save the settings and close the screen.
Note: setting the button Volume to zero will mute the buttons sound
completely.
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2. Tap the up and down arrows to change the screen lock time. The slider
displays the changed time accordingly.
Select the Disable Auto Lock to enable or disable the screen lock (works
as a toggle). When the box is selected the automatic activation of the lock
screen is disabled.
If you enabled the screen lock the screen saver options are displayed.
Note: the screen-saver options are not available when the Auto Lock is
disabled.
3. Select the Enable Screen Saver box to enable or disable the screen-saver
(works as a toggle). When the box is selected the screen saver is
enabled.
4. Tap the relevant screen saver option you want: Dim or Screen Off.
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2. Tap the up or down arrows of the settings that you want to change: Year,
Month, Day, Hour, or Minute.
Note: When changing the date, it may be possible to select a non-valid
date (such as 31-Feb). The ventilator, however, will not accept it, and the
date will remain the same.
3. Verify that the date and time you have inserted are the correct ones.
4. Verify that the green indicator is lit under the desired date format
5. Tap Accept all to save the settings and close the screen.
6. Examine the time and date display at lower right side of the Main screen
to verify that the date and time have been changed and that they are
correct.
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2. Tap the box to select or clear it (works as a toggle). When the box is
selected the O2 functionality is enabled.
3. Tap Accept to save the settings and close the screen.
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3
Not applicable for units with SW version prior to 2.0
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3. Tap, hold and slide from left to right the slider on the bottom
(Three dots mark the slider start position)
4. Completing the slide will enable the Clinical View option
Note: Not applicable for units with SW prior to 2.0
4. Tap Update.
The ventilator locates the software installer within the USB flash
drive and starts the update.
The update process may take up to 15 minutes during which time
the device should be left undisturbed. During the update procedure
the device displays a blank screen for a period of time.
Note: SW versions > 1.2.3 will display progress bar during
installation
During the update, the device emits a continuous beep from the
buzzers, which is normal part of the process.
Note: when the process is complete, no confirmation box is displayed
and you are returned to the Main screen.
Note: If after the 15 minutes the device fails to reboot and operate as
normal remove the USB flash drive, reboot and verify that the device
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2. Tap the check box which reflects the ventilator’s hardware setup, either
One Limb or Two Limbs.
3. Tap Accept. The patient configuration is changed accordingly.
4. Tap Restart. After a few seconds the GUI is restarted with the configured
language.
If you tap Cancel, next time the GUI is restarted it will start with
the language you have selected during the Set language process.
2. Tap the reset button in order to reset the Therapy Time counter
5. Tap Restart. The iVent101 will restart with the new Language Package.
6. Remove the USB flash drive from the USB port.
The device verifies that a USB flash drive is connected. It creates a new
folder ‘101DataStorage’ and copies the files into it.
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Required Equipment:
One Limb or Two limb patient circuit according to the configuration.
22mm sealing cap
Test Procedure:
1. Ensure that device is powered up and in Standby mode.
2. Connect a patient circuit to the Inspiratory and Expiratory ports
accordingly (refer to Figure 1.1).
3. From the Main screen tap the (Patient Tube Testing) button.
The Patient Tube Testing screen is displayed.
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Testing Procedures
6. The iVent closes the POV and activates the Hold solenoid.
7. The iVent reopens the POV.
The following criteria are checked:
i. If the inspiratory flow sensor reading is less than 1000ml/s the
Patient Tube
Testing pass
Patient Tube Testing fails.
Criteria ii. In Two limb configuration if the exhalation flow sensors
reading is less than 1000 ml/s the Patient Tube Testing fails.
8. The iVent will attempt to perform calibration of the compliance
(ml/cmH2O) and the resistance (cmH2O/lpm) of the patient tubing
system. Doing it by ventilate 10 times, and measures the tube
compliance.
9. When the test ends a message appears on the lower left side of the
screen: “Test passed successfully.”
10. Tap Save, and remove the 22mm sealing cap from the patient wye.
If, after doing all the above, the Patient Tube Testing fails:
1. Replace the patient circuit and repeat the test.
2. Replace the exhalation valve and repeat the test.
3. If fails: perform a Ventilator Ventilation Tests, refer to section 5.2:
Ventilator Verification below.
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Testing Procedures
4. From the Clinical view tap Menu – Services – Expert Services (refer to
section 4.4.2)
5. In the Expert Services screen, tap VVT.
The VVT screen is displayed, as shown in Figure 5.3 below:
Note: Make sure sensors calibration has pass successfully prior to the
Pneumatic Unit test.
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Testing Procedures
5.2.4.1. Pressure Test
The VVT pressure test verifies systematically the operation of the
following ventilator components:
Proportional Outlet Valve (POV)
Blower Motor
Blower pressure sensor
Patient pressure sensor
Exhalation valve
The test procedure takes approximately 15 seconds to complete.
Test Procedure:
1. From the Pneumatic Unit screen tap the arrow near the Pressure Test.
The Pressure Test VVT screen is displayed.
Pressure Test 8. Blower pressure test – the measured pressure should be within
pass criteria + 5cmH20 of the target pressure.
If the measured pressure falls outside this range the test fails.
9. Patient pressure test – the measured pressure should be within
+ 5cmH20 of the target pressure.
If the measured pressure falls outside this range (+ 5cmH20) the
test fails.
10. Exhalation test – the ventilator performs Easy Exhale.
If the measured patient pressure is found to be greater than 70% of
the target pressure the test fails.
Test Procedure:
The Flow test screen is displayed automatically when the Pressure test is
completed.
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Testing Procedures
1. The Flow Test screen displays instruction on how to configure the device
and test equipment.
2. When performing the Flow test with Two limb configuration, connect the
TSI to the expiratory port. Ensure that the flow arrow on the TSI is
oriented correctly using the extension tube.
When performing the flow test with One limb configuration, connect
the TSI to the inspiratory port using the extension tube. Ensure that
the flow arrow on the TSI is oriented correctly.
3. Connected the expiratory limb to the TSI outlet.
4. Connect the TSI power supply to the flow meter and connect it to the
mains supply.
5. Connect the serial cable from the TSI to the ventilator USB port using
appropriate USB adaptor.
6. Seal the patient wye with 22mm sealing cup.
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Testing Procedures
Test Procedure:
The Leak Test VVT screen is displayed automatically when the flow test
is completed.
1. The Leak Test screen displays instruction on how to configure the device
and test equipment.
Leak Test 2. Disconnect the TSI from the test setup and set aside.
Procedure
3. Connect the appropriate type of tubing system to the device.
4. Connect an Rp 20 resistor and 2L test lung to the wye.
5. Tap Start when the test lung is connected.
6. The ventilator delivers flow to the patient system and energizes the hold
pump and solenoid to seal the exhalation valve.
7. The Ventilator closes the POV and monitors the patient pressure and
inspiratory and expiratory flow sensors.
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Leak test If a negative flow is detected by the inspiratory flow sensor the test
pass fails, indicating a leak through the check valve.
criteria
If the flow is detected by the expiratory flow sensor the test fails,
indicating a leak through the exhalation valve or problem in the hold
circuit.
8. When the test is completed, the VVT results for the Pneumatic Unit are
displayed on the right panel of the screen.
If the Pneumatic unit VVT fails:
TEST FAILED DESCRIPTION TROUBLESHOOTING
1. Make sure all tubes and TSI are
intact and well connected as
describe in the instructions.
2. Make sure the tube type that
connected to the device is
compatible with the tube
configuration settings in
Technical Config screen
1. Patient tube is not connected
(1 Limb / 2 Limbs).
properly.
3. Perform sensors calibration
2. Incorrect tube type.
(section 6.5.2) and then Perform
3. Inner tubes to the pressure VVT again.
sensors are not connected
4. If the test fails, run Factory
properly.
Pressure calibration – PU Devices (section
test 4. Blower pressure sensor is 6.4.4), and perform VVT again.
malfunctioning.
5. Replace the technician
5. Patient pressure sensor is exhalation valve (section 10.3.2).
malfunctioning.
6. If the test fails open the machine
6. POV is stuck. and verify that all tubes to the
7. Turbine is malfunctioning. pressure sensors are not kinked
and well connected and in the
correct place.
7. Replace the main PCB (section
10.3.12).
8. Replace the Pneumatic unit
(section 10.3.13).
Testing Procedures
TEST FAILED DESCRIPTION TROUBLESHOOTING
1. Make sure that tubes and TSI are
intact and well connected as
describe in the instructions.
2. Make sure the tube type that
connected to the machine is
compatible with the tube
configuration settings in
Technical Config screen
(1 Limb / 2 Limbs).
1. Patient tube is not connected 3. Replace the technician
properly. exhalation valve (section 10.3.2).
2. Incorrect tube type. 4. Perform sensors calibration
(section 6.5.2), and then perform
3. Occluded exhalation valve. VVT again.
4. Inner tubes to the flow sensors 5. If the test fails, run Factory
Flow are not connected properly.
calibration – PU Devices (section
Test 5. Inhale flow sensor is 6.4.4), and then perform VVT
malfunctioning. again.
6. Exhale flow sensor is 6. If the test fails open the device
malfunctioning. and verify that all tubes to the
flow sensors are not kinked and
well-connected and in the
correct place.
7. Replace the Pump/Solenoid
harness (section 10.3.18).
8. Replace the main PCB (section
10.3.12).
9. Replace the Pneumatic unit
(section 10.3.13).
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Testing Procedures
Test Procedure:
1. On the VVT screen tap the arrow near Power.
The AC power Connected Test screen is displayed.
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2. Tap Start.
3. The system runs two tests. .
The first test examines the AC power supply output, and fails if:
AC power is not available at the mains outlet
AC power does not reach the iVent101 due to malfunctioning
mains cable.
AC power does not reach the power supply due to
malfunctioning internal wiring or burnt fuse.
The output of the AC to DC power supply is not within the
AC power required range due to malfunctioning power supply or
test pass
criteria overload.
4. For the second test, the system disables all power sources except AC
power, and turns the turbine motor to full power.
The test fails if:
The output of the AC to DC power supply is not within the required
range when fully loaded by the turbine.
Note: Since all other power sources are disabled, failure in this test will
cause the iVent101 to enter backup mode (touch screen turns off, a
continuous beep sounds) until power becomes available again.
Test Procedure
The External Connected VVT Test screen is displayed automatically
when the AC connected test is completed.
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Testing Procedures
1. Disconnect AC power.
2. Follow the onscreen instructions: connect an external DC source to the
iVent101.
3. Tap Start.
4. With AC unavailable, the iVent101/ ClevAir switches to external DC as
power source, and verifies the external DC is connected and within the
specified voltage range.
External The first test fails if:
battery
connected External DC power is not connected.
pass criteria
The External DC voltage is not between 19-33V.
5. For the second test the iVent101/ ClevAir disables the internal battery,
and turns the motor to full power.
The test fails if:
External DC voltage is not between 19-33V when loaded by
the turbine.
Test Procedure
The External Battery Disconnect Test VVT screen is displayed
automatically when the external battery test is completed.
1. Before starting this test, make sure a sufficiently charged internal battery
is inserted to the iVent101.
2. Follow the on screen instructions: connect the AC mains power and
disconnect the external source.
3. Tap Start.
4. The iVent101/ ClevAir disables the AC power.
With External DC disconnected, the system switches to the internal
battery. The test fails if the internal battery does not engage.
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Testing Procedures
Test Procedure
1. Before starting this test, make sure a sufficiently charged internal battery
is inserted to the iVent101.
2. Follow the onscreen instructions: disconnect the AC power cable from
the ventilator.
3. Tap Start.
4. The iVent101/ ClevAir verifies that the AC power is disconnected, and
disables the external DC rail.
With External AC disconnected and external DC disabled, the
system switches to the internal battery. The test fails if the internal
battery does not engage.
Note: Since all other power sources are disabled or disconnected, failure
in this test may cause the iVent101 to enter backup mode (touch screen
turns off, a continuous beep sounds) until power becomes available
again.
Test Procedure:
1. The Internal connected test VVT screen is displayed automatically when
the AC disconnected test is completed.
Test Procedure
The Charger Test VVT screen is displayed automatically when internal
connected test is completed.
Released
Testing Procedures
Test procedure:
1. On the VVT screen tap the arrow near Sound Devices.
The Codec Test screen is displayed,
2. Tap Start
3. A Sound is generated and confirmation box will appear, press Yes
if the sound is audible , fails if:
o The speaker is not connected to the main board
o The speaker is defected
4. The Piezo Test screen is displayed,
5. Tap Start
6. A Sound is generated and confirmation box will appear press Yes
if the sound is audible , fails if:
o The buzzer is defected.
Released
Testing Procedures
o Malfunction within the Main Board,
7. The HW WD Buzzer test VVT screen is displayed,
8. Tap Start
9. A Sound is generated and confirmation box will appear press Yes
if the sound is audible , fails if:
o The buzzer is defected.
o Malfunction within the Main Board,
2. Tap Start
3. The Alarm LED will blink in Red color and confirmation box will
appear, press Yes if the blinking LED is visible, fails if:
o LED Flat connector is not connected or defected
o Touch Cable is not connected or defected
o Malfunction within the Main Board
Testing Procedures
If the Power VVT fails:
TEST FAILED DESCRIPTION TROUBLESHOOTING
Testing Procedures
Use the items that are in the Technician Kit for performing the test procedures
in this section, You MUST use the exhalation valve included in the kit.
Calibration Procedures
Calibration Procedure
1. Review the patient configuration setting (One or Two limb) and ensure
that that the appropriate hardware configuration is in use.
2. From the Calibration screen tap Sensors. The Sensors Calibrations screen
is displayed.
3. In Two limb configuration connect the TSI to the expiratory port using the
extension tube. Ensure that the flow arrow on the TSI is oriented
correctly.
Released
Calibration Procedures
Sensors Calibration – In One limb configuration, connect the TSI to the inspiratory port
Continues using the extension tube. Ensure that the flow arrow in the TSI is
oriented correctly.
It is recommended to connect a HME filter before the TSI when it
used in the calibration procedures.
4. Connect the TSI power supply to the flow meter and connect it to the
mains supply.
5. Connect the serial cable from the TSI to the ventilator USB port on the
ventilator rear panel using appropriate USB adaptor (refer to
Figure 1.2).
Sensors Calibration – 6. Connect the appropriate patient tubing and seal it with 22mm sealing
Continues
cap.
7. When all the equipment is set, tap Start to commence the calibration
procedure.
8. The procedure now runs automatically performing a calibration for each
of the flow and pressure transducers in use with the current
configuration.
This procedure takes approximately 40 seconds to complete.
9. On completion the Save box is displayed.
Calibration Procedure
1. From the Factory Calibration screen tap PU Devices. The first calibration
screen, the Turbine Factory Calibration screen is displayed.
Calibration Procedures
6.4.3. POV Factory Calibration
During Outlet Valve calibration the software will calibrate the device’s
proportional outlet valve (POV) assembly.
Note: If the unit is under one-limb configuration, use the 80mm silicone
tube attached to the technician kit as a jumper between the proximal
pressure line and the exhalation valve port as shown in Figure 6.4
Calibration Procedure
1. The POV Factory Calibration screen appears automatically when the
Turbine Factory calibration is completed.
Calibration Procedure
1. The PU Resistance Factory Calibration screen appears automatically
when the POV Factory calibration is completed.
2. Follow the onscreen instructions: connect a Two limb patient circuit, and
verify that the Wye is open, without a sealing cap, resistor, or Test lung.
3. When the equipment is set, tap Start to commence the calibration
process.
4. The procedure now runs automatically performing a resistance
calibration for the complete pneumatic system.
The procedure takes approximately 40 seconds to complete.
5. On completion the Save box is displayed, as shown in Figure 6.3.
6. Tap Save to save the calibration results.
7. The calibration status is displayed on the Calibration screen
Released
Calibration Procedures
6.5. Service Calibration Procedures
The service calibration procedures are part of the device maintenance.
These procedures include:
Sensors Calibration, refer to section 6.5.2, below.
Circuit Compensation, refer to section Error! Reference source not
found..
O2 Calibration, refer to section 6.5.3.
Calibration Procedure
1. Review the patient configuration setting (One or Two limb) and ensure
that that the appropriate hardware configuration is in use.
2. From the Calibration screen tap Sensors. The Sensors Calibrations screen
is displayed.
Released
Calibration Procedures
11. The calibration status is displayed on the Calibration screen.
6.5.3. O2 Calibration
During O2 calibration the software attempts to perform calibration of
the device’s internal FiO2 sensor against the maximum (100%) and
minimum (21%) oxygen levels. During normal operation the data is used
to ensure the accuracy of the FiO2 monitoring.
In addition to the intervals mentioned in section 6.5.1, the O2 calibration
should be performed after enabling the O2 sensor and when the FiO2
reading or alarms suggest that it may be necessary.
To perform the O2 Calibration in full only the patient circuit tubing
system, an oxygen flow (>99% purity) of 8 lpm (+1 lpm) and a low flow
O2 connector are required.
Calibration Procedure:
1. Review the device and ensure that the O2 sensor is installed and enabled.
You can enable the O2 sensor through the General Configuration screen.
2. From the Calibration screen select O2.
The O2 100% Service Calibration screen is displayed.
3. Follow the onscreen instructions: seal the patient outlet with a 22mm
sealing cap.
4. Connect a low pressure oxygen source to the O2 inlet connector on the
O2 100% device’s rear panel (see
Calibration Figure 1.2).
5. Set the O2 flow meter to deliver a flow of 8 lpm (+ 1 lpm).
6. Tap Start.
The flow meter flushed the pneumatic system with O2. The system
calibrates the O2 sensor against the 100% O2 reference.
This procedure takes 120 seconds (2 minutes) to complete.
Calibration Procedures
7. Turn off and disconnect the low pressure oxygen source from the
device’s rear panel.
8. Tap Start.
The device is flushed with ambient air (21% O2) to remove the O2.
O2 21%
The system calibrates the O2 sensor against 21% O2 reference.
Calibration
This procedure takes 90 seconds (1.5 minutes) to complete.
On completion the Save box is displayed, as shown in Figure 6.3.
9. Tap Save to save the calibration results.
10. The calibration status is displayed on the Calibration screen.
Released
Calibration Procedures
2. Tap Start.
3. The progress of the battery charging and discharging will be displayed
during the calibration process.
4. You will be informed when the calibration is successfully completed.
Battery Calibration completed screen is displayed
5. Touch the sign appears on the top left corner. It will change its location
four times more, keep following it and press on it whenever it appears.
The last press will restart the iVent101 automatically.
6. Remove the USB flash drive from the USP port as soon as it performs
restart. You will identify the restart by the Splash screen, which will be
displayed.
Released
Calibration Procedures
Performance Verification
Performance Verification
4. Use the alarm silence button as required during the performance
verification procedures to mute any alarms should they occur.
5. Except for use of the silence button, do not alter the control settings
during these procedures unless specifically instructed to do so.
6. If necessary refer to Section 10: Service and Repair for repair information,
and to Section 11: SPARE PARTS to identify repair parts. When repairs
are complete repeat the tests in full.
7.3.1.3. Calibration
Perform Sensors Calibration as described in section 6.5.2, and Circuit
Compensation (applicable for SW version prior to 2.0) as described in
section Error! Reference source not found..
7.3.1.7. O2 System
Only if the O2 system is used you need to perform this test.
The purpose of this test is to verify the accuracy of the oxygen
percentage measurements. This accuracy of the oxygen measurement
should be + 3% absolute up to 30% FiO2, + 7% absolute between 30 -
60% FiO2.
1. Set parameters according to table below:
Patient Ventilation Rate Vt. Peep P. Sensitivity High Compliance Resistance
Type Mode Limit PIP (on TTL) (on TTL)
Alarm
Adult SIMV Vctrl 12 500 5 60 2 60 0.02 20
2. Connect the ventilator to the oxygen supply through flow meter
3. Connect an external oxygen analyzer to the ventilator inlet.
4. Start ventilation and adjust oxygen flow to 2 L/min
5. Wait for 2 minutes.
6. Record FiO2 measured by iVent-101 and external oxygen analyzer.
7. Repeat the test for the oxygen flow 4 L/min. Record the results of the
measurements.
Released
Performance Verification
8. Disable the O2 sensor: Menu>General Config>Enable O2, unmark,
Press Accept).
Test Procedure
1. Connect the ventilator to AC power and oxygen supply.
2. Power up the device and switch to clinical view.
3. Connect an Rp20 Resistor and 2L Test Lung to the wye connector.
4. Tap Menu – New Patient, and accept the default ventilation settings for
adult patient type.
5. Tap the (OVT) button and perform an OVT to verify the integrity
of the patient circuit.
6. When the OVT complete tap Start on the main screen to commence
ventilation.
Patient Disconnect:
1. Disconnect the Rp20 restrictor and the Test Lung from the patient circuit.
Verify that the Patient Disconnect alarm is activated.
4. Reconnect the Rp20 restrictor and Test Lung to the patient circuit. Verify
that the Patient Disconnect alarm stops automatically.
AC Disconnect:
1. Disconnect the AC cable from the ventilator. Verify that AC Disconnect
alarm is activated.
2. Reconnect the AC cable to the ventilator. Verify that the AC Disconnect
alarm stops automatically.
Low Minute Volume:
Released
1. From the Main screen record the measured value for the Low Minute
Volume (M.vol).
2. Tap Settings – Alarms to open the Alarm Settings screen. Set the MV
alarm lower setting to a value above the measured value.
3. Tap Accept twice to close the Alarms Settings and Settings screen. Verify
that Low Minute Volume is activated one minute after Accept was
tapped.
4. Close the Alarm popup window and restore the alarm setting to its
default value. Verify that the alarm stops automatically after four
consecutive breaths.
High Pressure:
1. From the Main menu screen record the measure value for PIP.
2. Tap Setting – Alarms to open the Alarm Settings screen. Set the PIP
alarm high setting to a value below the measured value.
3. Tap Accept twice to close the Alarms Settings and Settings screen. Verify
that PIP alarm is activated five seconds after Accept was tapped.
4. Close the Alarm popup window and restore the alarm setting to its
default value. Verify that the alarm stops automatically after one breath.
Released
Performance Verification
Low FiO2:
1. Connect the flow meter of the concentrator to the O2 connector on the
ventilator back panel (refer to section 2.4: Connecting the Ventilator to
an Oxygen Source).
2. On the concentrator adjust the flow to 5L per minute (refer to the
manufacturer’s instructions if needed). Wait a few seconds until the FiO2
value stabilizes.
3. From the Main screen record the measured value for the O2.
4. Tap Setting – Alarms to open the Alarm Settings screen. Set the FiO2
alarm low settings to value above the measured value.
5. Tap Accept twice to close the Alarms Settings and Settings screen. Verify
that Low FiO2 alarm is activated one minute after Accept is tapped.
6. Close the Alarm popup window and restore the alarm setting to its
default value. Verify that the alarm stops automatically after four
breaths.
Apnea:
1. Tap Settings, and set the Rate to 2bpm.
2. Tap Accept. Verify that Apnea alarm is activated 20 seconds after Accept
is tapped, and the iVent101/ ClevAir switches to Apnea backup
ventilation.
3. Wait one minute and then squeeze the Test Lung three times to simulate
two subsequent patient initiated breaths. Verify that the Apnea alarm
stops and that the previous parameters are automatically restored.
4. Restore the Rate setting to its default value.
Released
Troubleshooting
Section 8: Troubleshooting
This section details how to troubleshoot common problems and error
codes that may be encountered while operating the iVent101/ ClevAir
ventilator system.
8.1.2. Diagnostics
1. Read the content of the logs, focusing on the time of the reported event:
a. If no laptop PC is available, use the iVent101 internal log viewer
(Menu – Log Book).
b. If a laptop PC is available, use the Log Translator to read all the
alarms logs.
2. Record occurrences of alarms – type of alarms, timing, repetition,
frequency, and specific numbers in specific log entries that may assist you
in diagnosing the problem.
3. Refer to the following sections within this troubleshooting section to
analyze the problem.
Troubleshooting
Troubleshooting
Troubleshooting
Troubleshooting
Troubleshooting
3. Touch panel
malfunction
4. Main board.
1. Check the Internal connections.
Blank screen after 1. Internal cable
switch on connections 2. Replace the top panel (section 10.3.8).
3. Replace Main PCB (section 10.3.12).
2. Touch panel
malfunction
3. Main board.
Leak reading with no 1. Patient circuit 1. Check the patient’s status and well-being. If
apparent reason connections ventilation is determined to be sufficient no
further action may be required.
2. Exhalation valve
positioning 2. Check the patient circuit for leaks, and
correct if found.
3. Erroneous leak
detection affected 3. See troubleshooting for “High leak from
by O2 exhalation valve”
4. If the leak reading disappears when
ventilating for some time without O2, and
ventilation is determined to be sufficient no
further action may be required even when
ventilating with O2 again.
4. If the problem persists and you experience
degradation of ventilation, provide
alternative means of ventilation and
contact qualified service personnel
Service notice alarm Restart following a 1. Make sure power sources are operational,
with code number 713 momentary loss of have at least one of them external (AC or
appears following a power external DC)
power loss condition
2. Restart the ventilator
Released
Troubleshooting
Planned Maintenance
Note: Dispose of all parts removed from the device according to your institution’s
protocol. Follow all local, state, and federal regulations with respect to
environmental protection, especially when disposing of the electronic device or
parts of it (for example, oxygen cell, batteries).
Planned Maintenance
Planned Maintenance
2. Perform the 12 months procedures as describe in section 9.2.2 above.
To prevent electric shock hazards always ensure that all electrical power has
been removed from the device prior to commencing service. This requires
that not only mains power be removed but also the device’s internal
Released
To prevent possible personal injury, always ensure that the high pressure
oxygen source has been disconnected.
10.1.3. Cleaning
If required, follow the general cleaning guidelines described in this
section when cleaning the ventilator during servicing. Procedures for the
periodic cleaning and sterilization of the ventilator and its accessories
are described in the iVent101 ventilator Operator Manual. Specific
procedures for periodic cleaning and inspection done during the
ventilators preventive maintenance are provided in Section 9: Planned
Maintenance.
Lever
handle
Lever
handle
8. Allow the O2 sensor to sit in room air for a minimum of 20 minutes prior
to attempting to calibrate it.
9. Install the replacement O2 sensor (or cork) taking care not to damage the
thread of the mating parts or the o-ring. Screw the replacement sensor in
place by hand tightly.
10. Carefully reconnect the O2 sensor harness (if applicable) and re-install
the O2 sensor cover piece using the hardware removed earlier.
Ground
cable Backlight
inverter
cable
Touch
cable
Display
flat cable
Mounting
screws
Mounting
screws
3. Place the device back onto its lower enclosure and remove the screw (M3
x 8mm) retaining the main enclosure at the exhalation housing.
4. Lift the main enclosure up and away from the device, and while doing so,
reach inside and disconnect the cooling fan harness.
Released
Fans connector
J23
Screws Position
4. Carefully remove the fans from the bracket and connect the
replacement fans.
5. Secure the fans assembly back into position using three screws that
were removed earlier.
6. Secure the main enclosure back in place as described is section
10.3.10.
7. Secure the top enclosure back in place as described in section 10.3.8.
Ground
Gas Gauge
cable Power Speaker
supply cable
Pump/Solenoid
cable cable
Backup battery
Motor cable
POV cable cable
O2 sensor
PU cable
Counter
cable
Ground
Not applicable
for all versions
4. On the upper side of the Main PCB, disconnect the sensor tubing from
the inspiration differential transducer.
On the lower side of the Main PCB, disconnect the sensor tubing from
the exhalation differential transducer, blower pressure transducer,
patient pressure transducer and inlet pressure transducer (and Exhale
pressure sensor in the old PU version). Refer to Figure 10.16 below.
Released
Low
High
Blower
pressure tube
Patient Low
High
pressure tube
5. Carefully remove the four screws securing the Main PCB position using a
2.5mm hex key, M3 x 6
6. Carefully lift the Main PCB free of the device and set it aside into
appropriate ESD packaging.
Note: Pay special attention to the supporting bracket not to harm the
patient pressure sensor
7. Take the replacement PCB, inspecting it first to ensure that ESD
packaging is fully intact.
8. Remove the replacement PCB from the ESD packaging and inspect it for
any signs of damage.
9. Set the replacement PCB in place and fasten it using the four screws
removed earlier.
10. Reassembly the PCB by reconnecting the sensor tubing, the blower
pressure transducer, the patient pressure transducer, and the inlet
pressure transducer (and Exhale pressure sensor in the old PU version).
Refer to Figure 10.16 above.
Released
11. Reconnect all of the electrical harnesses to the upper side of the PCB and
the grounds cables to the left (Not applicable for all HW versions) and
right side of the PCB. Refer to Figure 10.15 above.
Note: Take care not to place undue stress on the PCB when reattaching
the electrical connections.
12. Secure the main enclosure back in place as described is section 10.3.10.
13. Secure the top enclosure back in place as described in section 10.3.8.
O2
sample HPB Pressure
tube port
Hold Solenoid O2
sample
tube
Exhaust tube
O2 inlet tube
O2 sample
tube O2 sample
tube
Exhaust tube
15. Place back the main PCB and reconnect its tubing as
described in section 10.3.12.
16. Secure the main enclosure back in place as described is
section10.3.10.
17. Secure the top enclosure back in place as describes in
section 10.3.8.
If you have the second revision pneumatic assembly installed:
18. Disconnect the following tubing from the base enclosure:
box pressure line (circle 9), O2 inlet tube (circle 1), O2
sample tubes (two tubes, circles 6 and 7) and exhaust line
(circle 4). Refer to Figure 10.21 and Table 10-2: Pneumatic
unit rev. 2 tubing table below.
Released
10 9 7
1
2 3 4 5
6 7 8
19. Set the device back onto the rear of its lower enclosure.
20. Unscrew the four screws securing the pneumatic unit to
the lower enclosure, using a 10mm open-ended wrench.
21. Loosen the Main PCB mounting bracket to the left side by
slightly loose the self-tapping bolts in the base, to lift the
pneumatic unit.
22. Carefully lift the pneumatic unit up and free of the lower
enclosure taking care not to stress or damage the Main
PCB mounting lugs, and set the pneumatic unit aside.
23. Remove the replacement pneumatic unit from its
packaging and inspect it for any signs of damage.
24. Set the replacement pneumatic unit back into the lower
enclosure and screw it in position with the four screws
removed earlier with a torque of 1 Nm.
25. Tight the Main PCB mounting bracket
26. Re-establish the following tubing connections to the
pneumatic unit: box pressure line (circle 9), O2 inlet tube
(circle 1), O2 sample tubes (two tubes, circles 6 and 7) and
exhaust line (circle 4). Refer to Refer to Figure 10.21 and
Released
O2 Sample
HPB Pressure port tube
Exhaust tube
O2 Sample
tube
Plastic housing
27. Place back the main PCB and reconnect its tubing as
described in section 10.3.12.
28. Secure the main enclosure back in place as described is
section10.3.10.
29. Secure the top enclosure back in place as describes in
section 10.3.8.
Note: In case of old exhalation valve base, the solenoid will be attached to
the PU using the plastic housing.
With new exhalation valve base, use the designated location
Released
Backup
Battery
Connector J19
Back-up
Battery
6. Carefully install the replacement item on the Main PCB while handling as
little as possible.
7. Secure the main enclosure back in place as described in section 10.3.10.
8. Secure the top enclosure back in place as described in section 10.3.8.
9. Start the machine by pressing On/off switch. Wait until GUI startup.
10. Set correct date and time (refer to section 4.2.2).
11. Reboot the machine by pressing On/off switch for off and immediately,
after machine go down, press On/off switch for on the machine. Wait
until GUI startup.
12. Examine the time and date display at lower right side of the Main screen
to verify that the date and time have not changed to previous time.
Solenoid locking
latch
Pump
Power Supply
Power Supply
Mounting Screws
13. Remove the 3 counter sunk screws from inside the battery enclosure
using a small Philips screwdriver.
14. Carefully remove the power supply module and harness from the base.
15. Remove the replacement base assembly from its packaging, and inspect it
for any signs of damage.
16. Set the power supply in position in the new base and fasten it in place by
screwing the screws removed earlier.
17. Reconnect the Power supply harness the base.
Released
Formex box
Power Supply
Harness
Power Supply
Figure 10.29: Power supply location
18. Fix Formex cover box (as open sheet) in place on the base top using the
adhesive areas.
19. Reassemble the back panel assembly, Refer to section 10.3.20.
20. Reconnect the AC power entry harness.
21. Put back the pneumatic unit in place and assemble, Refer to section
10.3.11 on page 176.
22. Put back the main PCB and reconnect its tubing as described in section
10.3.11, on page 172.
23. Secure the main enclosure back in place as described in section 10.3.10,
on page 170.
24. Secure the top enclosure in place as described in section 10.3.8, on page
168.
25. Reinstall the power pack into place as described in section 10.3.6, on page
166.
Released
Note: Two revisions of the exhalation valve base are available in the field they
can be distinguishing according to the physical dimensions:
5. Put back the main PCB and reconnect its tubing as described in section
10.3.12.
6. Secure the main enclosure back in place as described in section 10.3.10.
7. Secure the top enclosure in place as described in section 10.3.8.
8. Reinstall the power pack into place as described in section 10.3.7.
Perfor- Patient
Service PU Power Sensor Factory O2 Touch Alarm
mance Tube OVT
Performed VVT VVT Cal Cal Cal Screen Cal Tests
Tests Comp
Inlet Filter
- -- -- -- -- -- -- -- -- --
Replacement
Exhalation
Valve -- -- -- -- -- -- -- -- --
Replacement
One /Two Limb
changeover
-- -- -- -- -- --
O2 Sensor
Replacement
-- -- -- -- -- -- -- -- --
Mains AC fuse
Replacement
-- -- -- -- -- -- -- -- --
Power Pack
Replacement
-- -- -- -- -- -- -- -- --
Top Panel
Replacement
-- -- -- -- -- -- -- --
Filter Housing
Replacement
-- -- -- -- -- -- -- --
Main Enclosure
Replacement
-- -- -- -- -- -- -- --
Released
Perfor- Patient
Service PU Power Sensor Factory O2 Touch Alarm
mance Tube OVT
Performed VVT VVT Cal Cal Cal Screen Cal Tests
Tests Comp
Fans
Replacement
-- -- -- -- -- -- -- -- --
Main PCB
Replacement
Pneumatic
System --
Replacement
Back-Up Battery
- -- -- -- -- -- --
Replacement
RTC Battery
-- -- -- -- -- --
Replacement
Speaker
- -- -- -- -- -- 1
Replacement
O2 sensor
harness - -- -- -- -- --
Replacement
Pump/Solenoid
harness -- -- -- -- -- --
Replacement
Power supply
Replacement
- --
Back Panel
-- - -- --
Replacement
Base
Replacement
Exhalation valve
base -- -- -- -- -- -- --
Replacement
Spare Parts
2 1
9
10
Spare Parts
Table 11-2: Main Assemblies
Spare Parts
NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
assembly,
ClevAir
- 900BL009-01 M1184159 Back Panel
assembly,
iVent101
4 900HC010-01 N/A Ground cables
kit, ClevAir
- 900BL010-01 M1184161 Ground cables
kit, iVent101
5 504HC055-01 N/A Respiratory Kit,
ClevAir
- 504BL055-01 M1185990 Respiratory Kit,
iVent101
6 900P0106-01 M1184164 2-Liter
Breathing lung,
ClevAir
- 900P0107-01 M1185991 2-Liter
Breathing lung,
iVent101
8 900P0102-01 N/A Machine
Packing kit,
ClevAir
- 900P0103-01 M1184168 Machine
Packing kit,
iVent101
9 900HC011-01 N/A Tubing kit,
ClevAir
- 900BL011-01 M1185992 Tubing kit,
iVent101
10 900HC012-01 N/A Exhalation
valve base kit,
ClevAir
- 900BL012-01 M1185993 Exhalation
valve base kit,
iVent101
Released
Spare Parts
NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
11.2.4. Accessories
Table 11-4: Accessories
Spare Parts
NO. VERSAMED PART NUMBER VERSAMED PART DESCRIPTION
NUMBER
iVent101
2 900HC030-01 N/A Remote Alarm
cable, ClevAir
- 900BL030-01 M1186006 Remote Alarm
cable, iVent101
3 910A0002-01 M1182959 Technician Kit
(w/o TSI)
- 910A0001-01 M1182956 Technician Kit
Spare Parts
Note:
Spare Parts
Spare Parts
Last VVT – Lists the date and time when the VVT procedure was
performed. On the right side the status of the last VVT is displayed:
succeeded or failed.
Last OVT – The last time that OVT procedure was performed. On
the right side the status of the last OVT is displayed: succeeded or
failed.
2.2. Tap the box to select or clear it (works as a toggle). When the box is
selected the O2 functionality is enabled.
2.3. Tap Accept to save the settings and close the screen.
Released
3. Technical Logbook
The Technical Logbook screen displays chronologically details on
technical events which have occurred on the ventilator. The date and
time of the event are displayed on the left side of the screen, and a
description of the event is on the right side.
To open the Technical Logbook:
3.1. On the Services screen tap Technical Logbook. The Technical Event
Log Book is displayed.
Spare Parts
4. Circuit Compensation
During the circuit compensation test the device will attempt to perform
calibration of the compliance (ml/cmH2O) and the resistance
(cmH2O/lpm) of the patient tubing system.
During normal operation these factors are used to correct breath
delivery and the monitoring of the tubing system, thus ensuring
ventilation at the set parameters.
In addition to intervals mentioned in section 6.5.1, the circuit
compensation calibration should be performed any time that the patient
tubing configuration is changed between Two and One limb, or any time
there is a significant change in the tubing type, for example Infant
(10mm tubing) to Adult (22mm tubing), or when the Patient Tube
Testing indicates that it may be necessary.
To perform the circuit compensation test only the desired patient tubing
and the 22mm sealing cap are required
Calibration Procedure
Tube Compliance 1. Review the patient configuration setting (One or Two limb) and ensure
Calibration – Continues that the appropriate hardware configuration is in use.
3. Follow the onscreen instructions: seal the patient circuit with a 22mm
sealing cap.
4. Tap Start. The device tries to ventilate 10 times, and measures the tube
compliance.
Tube Compliance
Calibration This procedure takes approximately 10 seconds to complete.
On completion the Tube resistance Calibration screen is displayed as
shown in Figure 11.8Error! Reference source not found. below.
Spare Parts
5. Follow the onscreen instructions: remove the 22mm sealing cap from the
patient circuit.
6. Tap Start.
This procedure takes approximately 5 seconds to complete.
Tube Resistance
Calibration On completion the Save box is displayed, as shown in Figure 6.3,
7. Tap Save to save the calibration results.
8. The calibration status is displayed on the Calibration screen.
This procedure may take 5 hours for the standard battery or 10 for the
extended battery.
4. Wait until the icon is displayed on power status area at the lower
right side of the screen.
This procedure may take 15 hours for the standard battery or 28 for the
extended battery.
Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).
Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).
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Note: It is highly recommended to run this procedure in a room
temperature of 17-25°C.
When the ventilator is charged in a room temperature. The time may change depending on the battery
capacity and temperature.
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Spare Parts
Intended use
The ivent101 version 2.0 upgrade kit provides informative and complimentary tools that required for the new
version.
Kit Description
Notes:
iVent101 SW 2.0 CD (PN: M1225601) is available for ordering through the normal channels
It is required to perform OVT and VVT after the upgrade is done
After upgrading SW to version 2.0 downgrade is not supported
The upgrade process must performed by qualified Versamed iVent101 technician
To upgrade iVent101 unit:
1. Use the dust cap as cover to the RS-232 port
2. Secure the cover in place using 2 Philips screws as described in the figure below:
2 Philips
Screws
Follow instruction in the Technical reference manual (M1186102) section 4.4.5: Software update.
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d) The use of accessories, transducers and cables other than those specified, with the exception of transducers
and cables sold by the manufacturer of the iVent101 as replacement parts for internal components, may
result in increased emissions or decreased immunity of the iVent101
e) The iVent101 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary, the iVent101 should be observed to verify normal operation in the configuration in which it
will be used.
d) The use of the accessory, transducer or cable with equipment and systems other than those specified may
result in increased emissions or decreased immunity of the iVent101.
Electro-magnetic emissions
The iVent101 is designed to be used in the electro-magnetic environment specified below. The equipment’s
customer or user must ensure that it is used in such an environment.
Emission test Compliance Recommended electro-magnetic environment
RF emissions The iVent101 uses RF energy only for its internal function. Therefore
Group 1 its RF emissions are very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
RF emissions
CISPR 11
Class B The iVent101 is suitable for use in all establishments, including
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Spare Parts
Harmonic domestic establishments and those directly connected to the public low-
emissions Class A voltage power supply network that supplies buildings used for domestic
IEC 61000-3-2 purposes.
Voltage
fluctuations/flicke
Complies
r emissions
IEC 61000-3-3
Electro-magnetic immunity
The iVent101 is designed to be used in the electro-magnetic environment specified below. The equipment’s
customer or user must ensure that it is used in such an environment.
IEC 60601 test Compliance
Immunity test Recommended electro-magnetic environment
level level
Electrostatic The floors should be wood, concrete or ceramic tile. If
± 6 kV contact ± 6 kV contact
discharge (ESD) the floors are covered with synthetic material, the
± 8 kV air ± 8 kV air
IEC 61000-4-2 relative humidity should be at least 30%.
± 2 kV on
± 2 kV on power
Electrical fast power supply
supply lines Mains power quality should be that of a typical
transient/ burst lines
± 1 kV on input / commercial or hospital environment.
IEC 61000-4-4 ± 1 kV on input
output lines
/ output lines
± 1 kV
± 1 kV
differential
Surge differential Mains power quality should be that of a typical
mode
IEC 61000-4-5 mode ± 2 kV commercial or hospital environment.
± 2 kV common
common mode
mode
< 5% UT < 5% UT
(>95% dip in UT) (>95% dip in Mains power quality should be that of a typical
Voltage dips, for 0.5 cycles UT) for 0.5 commercial or hospital environment. If the user of the
short 40% UT cycles 40% UT iVent101 requires continued operation during power
interruptions and (60% dip in UT) (60% dip in UT) mains interruptions, it is recommended that the
voltage for 5 cycles for 5 cycles
variations on 70% UT 70% UT iVent101 be powered from an uninterruptible power
power supply (30% dip in UT) (30% dip in UT) supply or a battery.
input lines for 25 cycles for 25 cycles
IEC 61000-4-11 < 5% UT < 5% UT Note: Voltage reduction didn't influence the iVent101
(>95% dip in UT) (>95% dip in which is always supplied with the back up battery
for 5 s UT) for 5 s
Power frequency
Power frequency magnetic fields should be at levels
(50/60 Hz)
3 A/m 3 A/m characteristic of a typical location in a typical commercial
magnetic field
or hospital environment.
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
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NOTE 1: At 80 MHz and 800 MHz, the highest frequency interval is applied NOTE 2: This guide is not applicable in
every situation. The issue of electro-magnetic waves is affected by the absorption and the reflection of structures,
objects and people.
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(a) The ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz,
13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz.
(b) Compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are
intended to decrease the likelihood that mobile/portable communication equipment could cause interference if it is
inadvertently brought into patient areas. This is why an additional 10/3 factor is used in calculating the distance of
separation for emitters in these frequency ranges.
(c) Fields from fixed emitters, such as cordless telephone bases, mobile radios, CB radios, AM and FM radio emissions,
TV emissions may not be accurately predicted in theory. In order to evaluate the electro-magnetic environment from
fixed emitters, an electro-magnetic surveillance site must be considered. If the force field measured in the
environment where the iVent101 has to be used, exceeds the above applicable RF levels, the iVent101 must
be watched to check if it is working normally. If abnormal performance is observed, extra measures have to be taken
such as redirecting or moving the iVent101.
(d) Above the 150 kHz to 80 MHz frequency range, force fields should be less than 10 V/m.
NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range is applied.
NOTE 2: ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz,
13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz.
NOTE 3: An additional factor of 10/3 is used in calculating the separation distance for emitters in the 150 kHz and 80
MHz ISM range as well as the frequency range between 80 MHz and 2.5 GHz in order to reduce the probability that
mobile/portable communication equipment causes interference if they are unknowingly taken near the patient.
NOTE 4: This guide is not applicable in every situation. The issue of electro-magnetic waves is affected by the
absorption and the reflection of structures, objects and people.
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Index
O2 sensors......................................62
A
Sound Levels...................................56
AC connected test ..............................92 Configuration Screen
AC Disconnected test..........................96 Lock screen.....................................57
AC Power............................................47 Configuration screens
AC Power Disconnect test...................96 Date ...............................................59
Air Inlet Filter .....................................36 Time ...............................................59
Alarm .................................................56 Cooling Fans .......................................52
Alarm Sound Levels ............................56 Copy Log File ......................................75
Alarms Tests .....................................133
D
B
Date ...................................................59
Back Up Battery........................ 151, 183 Dual limb Patient Circuit.....................23
Backlight Inverter PCB ........................52
E
Backup Battery ...................................49
Battery Enclosure ................................... 36, 169
Backup............................................49 Exhalation Valve ... 41, 43, 151, 161, 164,
Integrated.......................................21 165
Battery Gas Gauge............................ 122 Expert.................................................65
Expert Services...................................63
C
External Dc Power .............................. 47
Calibration External Disconnected Test ................94
factory calibrations .......................105 External Test ......................................93
FiO2..............................................117
F
Outlet valve calibration ................109
pneumatic resistance calibration ..110 Factory Calibrations.......................... 105
Sensors.........................................112 Fan .....................................................52
Service calibration ........................112 Filter
Troubleshooting ........................... 126 Air Inlet ..........................................26
Tube Compensation......................114 Filter...................................................26
Tube resistance ............................ 114 Filter................................................. 148
Turbine calibration .......................107 Filter................................................. 151
CDC Procedure .................................123 Filter................................................. 160
Charge-Discharge-Charge cycle 120, 122 Filter Housing ................................... 171
Charger Test .......................................97 FiO2 ....................................................43
Circuit Compensation .......................114 Flow Sensor........................................41
Cleaning and Routine Planned Flow Test............................................85
Maintenance ................................ 148 G
Configuration screen
Gas Gauge PCB ...................................49
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Indicator Lights...................................52 P
Inlet Filter.............. 26, 36, 148, 151, 160 Patient Circuit.....................................22
Integrated Battery ........................ 21, 48 Dual limb ........................................23
Charge ..........................................123 One limb.........................................24
Interface PCB......................................51 Patient Configuration ......................... 72
L Patient Pressure Transducer...............41
Patient Tubing Test............................. 79
Labels .................................................13 PCB
LCD Touch screen ...............................51 Interface.........................................51
Leak Test ............................................87 Pneumatic Unit............................... 51
LEDs ...................................................52 PCB
Lock screen configuration...................57 Main...............................................50
Log File ...............................................75 PCB
Low Flow O2 connector ......................27 Backlight Inverter ........................... 52
Low Flow O2 connector with locking nut Planned Maintenance
.......................................................28 Every 12 Months .......................... 151
Low Oxygen Supply ............................26 Every 6 Months ............................ 151
M Planned Maintenance ...................... 152
Pneumatic Resistance Calibration..... 110
Main Alarm Speaker ...........................52
Pneumatic System.............................. 32
Main Enclosure.................................172
Pneumatic Unit......................... 152, 177
Main PCB.................................... 50, 174
Pneumatic Unit PCB............................ 51
Manifold.............................................36
Pneumatic Unit Test ........................... 83
MDI ....................................................25
POV ....................................................37
Membrane ................151, 161, 164, 165
Power Pack............................... 151, 168
Memory Card .....................................51
Power Sources....................................19
O Power Supply ................................... 190
O2 Calibration ..................................117 R
O2 Connector
Real Time Clock Battery............ 152, 185
Low Flow O2 connector ..................27
Low Flow O2 connector with locking S
nut..............................................28 Sensors Calibration........................... 112
O2 Sensor.........................................166 Service calibration ............................ 112
O2 sensors
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Index
Service Notice ..................................137 Troubleshooting ............................... 146
Service Notices Numbers..................138 Turbine...............................................37
Service Screen ....................................63 Turbine Calibration........................... 107
Copy Log File ..................................75 Turbine Pressure Transducer..............39
Patient Configuration .....................72 Two Limb...................................... 40, 72
Setup Configuration........................75 U
Software Update ............................70
Technical Info .................................68 Updating the battery gas gauge........ 122
Software Update ................................70 V
Sound Levels
Alarm..............................................56 Ventilation Circuit Test .......................79
Button ............................................56 VVT ....................................................81
Strut ....................................... 39, 40, 41 AC connected test .......................... 92
Symbols..............................................13 AC Disconnected test......................96
AC Power Disconnect test...............96
T Charger Test ...................................97
Technical Info .....................................68 External battery test.......................93
Tests External Disconnected Test ............94
Alarms ..........................................133 Flow Test ........................................85
Time ...................................................59 Leak Test ........................................87
Top Enclosure...................................169 Pneumatic Unit............................... 83
Touch screen ......................................51
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Warranty
This Product is sold by VersaMed under the warranties set forth in the following
paragraphs. Such warranties are extended only with respect to the purchase of this
Product directly from VersaMed or VersaMed’s Authorized Dealers as new merchandise
and are extended to the Buyer thereof, other than for the purpose of resale.
For a period of twelve (12) months from the date of original delivery to Buyer or to
Buyer’s order, but in no event for a period of more than two years from the date of
original delivery by VersaMed to a VersaMed Authorized Dealer, this Product, other
than its expendable parts, is warranted against functional defects in materials and
workmanship and to conform to the description of the Product contained in this
Technical Reference manual and accompanying labels and/or inserts, provided that the
same is properly operated under the conditions of normal use, that regular periodic
maintenance and service is performed and that replacements and repairs are made in
accordance with the instructions provided. This same warranty is made for a period of
thirty (30) days with respect to expendable parts.
The foregoing warranties shall not apply if the Product has been repaired other than by
VersaMed or in accordance with written instructions provided by VersaMed, or altered
by anyone other than VersaMed, or if the Product has been subject to abuse, misuse,
negligence, or accident.
VersaMed’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under
the above warranties is limited to repairing or replacing, free of charge, at VersaMed’s
option, a Product, which is telephonically reported to the nearest VersaMed Customer
Service Center and which, if so advised by VersaMed, is thereafter returned with a
statement of the observed deficiency, not later than seven (7) days after the expiration
date of the applicable warranty, to the VersaMed Customer Service and Distribution
Center during normal business hours, transportation charges prepaid, and which, upon
VersaMed examination, is found not to conform with above warranties. VersaMed shall
not be otherwise liable for any damages including but not limited to incidental damages,
consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. VersaMed makes no warranty of merchantability or fitness for a
particular purpose with respect to the product or parts thereof.
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Index