Datex-Ohmeda INOvent User and maintenance manual
INOvent delivery system
Operation and Maintenance Manual
CGA Variant
User Responsibility
This Product will perform in conformity with the description thereof contained in
this operating manual and accompanying labels and/or inserts, when
assembled, operated, maintained, and repaired in accordance with the
instructions provided. This Product must be checked periodically. A defective
Product should not be used. Parts that are broken, missing plainly worn,
distorted, or contaminated should be replaced immediately. Should repair or
replacement become necessary, Datex-Ohmeda recommends that a telephonic
or written request for service advice be made to the nearest Datex-Ohmeda
Field Service Support center. This Product or any of its parts should not be
repaired other than in accordance with written instructions provided by DatexOhmeda and by Datex-Ohmeda trained personnel. The Product must not be
altered without the prior written approval of Datex-Ohmeda’s Quality Assurance
Department. The user of this Product shall have the sole responsibility for any
malfunction which results from improper use, faulty maintenance, improper
repair, damage, or alteration by anyone other than Datex-Ohmeda.
w WARNING U.S. Federal and Canadian law restrict this device to sale by or on the or-
der of a licensed medical practitioner. Outside the U.S.A. and Canada,
check local laws for any restriction that may apply.
Inhaled Nitric Oxide mixtures must be handled and stored in compliance
with federal, state and local regulations.
Datex-Ohmeda products have unit serial numbers with coded logic which
indicates a product group code, the year of manufacture and a sequential unit
number for identification.
A 12345
AAA
This alpha character indicates the year of product
manufacture and when the serial number was
assigned; “B” = 1998, “C” = 1999, “D” = 2000, etc.
“I” and “O” are not used.
02/08/00 1605-0014-000
Contents
1/Introduction
2/General Information
3/Setup
Definitions and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Symbols used in this manual or on the system . . . . . . . . . . . .1-4
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Configuration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Main component views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Display and user controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Theory of operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
NO Flow from the cylinder to the patient
breathing circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Effect of inserting the INOvent into a
breathing circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
NO delivery system connections . . . . . . . . . . . . . . . . . . . . . . .3-2
Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
System connections . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Electrical connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Cylinder concentration . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Hourmeter display. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
To set the alarm loudness. . . . . . . . . . . . . . . . . . . . . . .3-10
To set the display brightness . . . . . . . . . . . . . . . . . . . .3-11
4/Calibration
1605-0014-000 02/08/00 i
Calibration information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
NO, NO
NO, NO
And O
2
calibration (daily, room air) . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
And O
2
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Sensor low range
2
Sensor high range calibration . . . . . . . . . . . .4-5
2
INOvent delivery system
5/Pre-Use
Procedures
6/Operation
1. Initial connections and leak test . . . . . . . . . . . . . . . . . . . . . 5-2
2. System purge and performance test . . . . . . . . . . . . . . . . . 5-3
3. Manual NO delivery system purge and performance test . 5-5
Before operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Connection to an ICU ventilator circuit . . . . . . . . . . . . . 6-4
Connection to a high frequency oscillatory
ventilator circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Connection to a circle anesthesia system . . . . . . . . . . 6-11
Connection to a transport ventilator circuit . . . . . . . . . 6-14
Connection to bagging systems . . . . . . . . . . . . . . . . . 6-16
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Setting or changing the delivered NO concentration. . 6-23
During operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Pausing NO flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Changing NO therapy cylinders and purging the
regulator assembly. . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
7/Alarms
8/Manual NO delivery
system
9/Troubleshooting
Electronic delivery shutdown. . . . . . . . . . . . . . . . . . . . 6-28
Monitoring the environment. . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
General alarm information . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
High, medium and low priority alarms . . . . . . . . . . . . . 7-2
Alarm silencing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Changing the alarm settings . . . . . . . . . . . . . . . . . . . . . 7-4
Alarm adjustment range . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Alarm adjustment procedure . . . . . . . . . . . . . . . . . . . . . 7-5
Clearing resolved alarm messages . . . . . . . . . . . . . . . . 7-7
Alarm message table. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Manual NO delivery system description . . . . . . . . . . . . . . . . . 8-2
Manual NO delivery system connections . . . . . . . . . . . . . . . . 8-3
Manual NO delivery system operation . . . . . . . . . . . . . . . . . . 8-4
Troubleshooting procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
If the system fails to operate properly . . . . . . . . . . . . . 9-2
ii
02/08/00 1605-0014-000
Troubleshooting guide index . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Troubleshooting guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
If the problem can’t be corrected using the
above suggestions. . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
If the INOvent delivery system must be returned
for servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
10/Maintenance
User maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . .10-2
INOvent delivery system cleaning. . . . . . . . . . . . . . . . . . . . . .10-4
Injector Module sterilizing and disinfecting . . . . . . . . . . . . . . .10-5
Autoclave sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
High level disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
Patient Circuit Adapters & Sample Line . . . . . . . . . . . . . . . . .10-6
Monthly System Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
1. Initial connections leak tests . . . . . . . . . . . . . . . . . . .10-7
2. Purge and system alarms tests. . . . . . . . . . . . . . . .10-10
3. Calibration and monitoring alarms . . . . . . . . . . . . .10-12
4. INOvent delivery system performance . . . . . . . . . .10-14
5. Manual NO delivery system purge and
performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-15
Emptying the Fluid Trap Bottle . . . . . . . . . . . . . . . . . . . . . . .10-17
Replacing the Fluid Trap Filter Cartridge . . . . . . . . . . . . . . .10-18
Replacing the NO
Replacing the NO Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . .10-20
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . .10-19
2
Replacing the O
Cleaning or replacing the Cooling Fan Filter. . . . . . . . . . . . .10-23
Fuse replacement and line voltage selection . . . . . . . . . . . .10-24
Replacing the high pressure hose CGA626 connector tip . .10-26
11/Parts and
Accessories
12/Appendix A -
Specifications
1605-0014-000 02/08/00 iii
Standard accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2
Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2
Replaceable parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3
Functional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2
Ventilator compatibility . . . . . . . . . . . . . . . . . . . . . . . . .12-2
Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . .10-22
2
INOvent delivery system
Injector Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Manual NO delivery system . . . . . . . . . . . . . . . . . . . . 12-3
NO delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Maximum NO delivery . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Gas monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Calibration Gas cylinders . . . . . . . . . . . . . . . . . . . . . . 12-5
Calibration Gas regulator . . . . . . . . . . . . . . . . . . . . . . 12-5
NO Delivery shutdown. . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
13/Appendix B -
Cylinder Information
14/Appendix C - Pre-
Use Procedures Card
15/Appendix D -
Transport INOvent
delivery system
Preparing the NO therapy gas cylinder for use . . . . . . . . . . 13-2
Replacing the NO therapy gas cylinder . . . . . . . . . . . . . . . . 13-3
NO therapy gas cylinder leak check . . . . . . . . . . . . . . . . . . . 13-4
Cylinder information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2
Battery operation information . . . . . . . . . . . . . . . . . . . 15-2
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-4
Regulator connection diagrams. . . . . . . . . . . . . . . . . . 15-4
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-5
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6
User maintenance schedule . . . . . . . . . . . . . . . . . . . . 15-6
Replaceable parts and accessories . . . . . . . . . . . . . . . . . . . 15-7
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-8
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-8
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-8
iv
02/08/00 1605-0014-000
16/Appendix E -
Optional Mounting
17/Appendix F -
Alternate Cylinder
Concentrations
Warranty
Cart mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-2
Shelf or table mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-4
Optional Cylinder Mount Regulator and
Hose assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-4
In ’Section 3/Setup’ of this manual . . . . . . . . . . . . . . . . . . . . .17-2
Cylinder concentration . . . . . . . . . . . . . . . . . . . . . . . . .17-2
In ’Section 5/Pre-Use Procedures’ of this manual . . . . . . . . .17-3
2. System purge and performance test. . . . . . . . . . . . 17- 3
3. Manual NO delivery system purge and
performance test. . . . . . . . . . . . . . . . . . . . . . . . . . . .17-3
In ’Section 10/Maintenance’ of this manual . . . . . . . . . . . . . .17-4
Monthly System Checkout . . . . . . . . . . . . . . . . . . . . . .17-4
4. INOvent delivery system performance . . . . . . . . . . .17-4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . W-1
1605-0014-000 02/08/00 v
INOvent delivery system
Notes:
vi
02/08/00 1605-0014-000
Introduction
1
ww
ww
WARNING If an alarm occurs, safeguard the patient first before
In this section
troubleshooting or repair procedures.
Use only pharmaceutical grade NO/N
Definitions and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols used in this manual or on the system . . . . . . . . . . . . 1-4
.
2
1605-0014-000 02/08/00
1-1
INOvent delivery system
Important
Before using the INOvent delivery system, read through this manual
and the related manuals provided. Read through the manuals for the
ventilator, humidifier and any other accessory items used. Follow the
manual instructions and obey Warnings and Cautions.
Know the proper setup and operation of the ventilator and the
humidifier you are using.
Know the proper information provided in this Operation and
Maintenance manual before operating the INOvent delivery system.
Keep this manual readily available to answer questions.
Read through each step or procedure to understand it before doing it.
All specifications in this manual are nominal.
Read the User Responsibility statement on the inside front cover of
this manual; it describes what the user must do to maintain this
product.
w
WARNING The INOvent delivery system must only be used in accordance
with the indications, usage, contraindications, warnings and
precautions described in the nitric oxide drug package inserts
and labeling. Drug package inserts and labeling are packaged
with each drug cylinder. Refer to this material prior to use.
The use of devices which radiate high-intensity electrical fields
may affect the operation of the delivery system. Do not drape the
leads of these devices across the delivery system. Constant
surveillance of all monitoring and life support equipment is
mandatory whenever interfering devices are in operation on or
near a patient.
1-2
02/08/00 1605-0014-000
Definitions and abbreviations
% v/v: % volume/volume
Button: A pushbutton control used to select a function.
Control wheel: Rotary control used to change and confirm
Display: The electronic information panel on the front of
HFOV: High frequency oscillating ventilator.
Menu: A list of available choices for an operation.
Introduction
settings or actions.
the delivery system.
Menu area: Area in the display where choice selections are
shown.
Message area: Area in the display where information is shown.
N
: Nitrogen.
2
NO: Nitric oxide.
NO
: Nitrogen dioxide.
2
NO/N
: Nitric oxide (NO) and nitrogen (N
2
) gas mixture.
2
Numeric area: Area in the display where values and settings
are shown.
: Oxygen.
O
2
Pop-up box: Menu or message which appears on the display.
1605-0014-000 02/08/00
Resolved alarm: An alarm whose cause has been corrected.
Set NO: The concentration of NO delivered by the
system as set by the user.
1-3
INOvent delivery system
Symbols used in the manual or on the system
WARNINGS and CAUTIONS tell you about dangerous conditions that
can occur if you do not obey all of the instructions in this manual.
Warnings tell you about a condition that can cause injury to the
operator or the patient.
Cautions tell you about a condition that can cause damage to the
equipment. Read and obey all warnings and cautions.
Other symbols replace words on the equipment or in this manual.
These symbols include:
On (power.)
ø
Off.
O
Standby.
o
Alternating current.
∏
Protective earth ground.
x
Earth ground.
y
Alarm Silence.
Equipotential.
Y
Plus, positive polarity.
+
Ê
π
≈
Ù
REF
SN
This way up.
Dangerous voltage.
Input.
Output.
Stock number.
Serial number.
Sample gas outlet.
Sensor connector.
O
2
Manual delivery system.
NO/O
2
1-4
Minus, negative polarity.
-
NO
Sensor.
2
02/08/00 1605-0014-000
Movement in one direction.
N
NO Sensor.
Introduction
134°C Autoclavable.
Not autoclavable.
Í
Type B equipment.
m
Type BF equipment.
µ
Warning and Caution symbol.
w
wW
Attention, consult accompanying
documents, IEC 601-1.
Sensor.
O
2
Product “Use by” information (indicating
warranty expiration date as YYYY-MM).
Replace fuse only as marked.
Indicates operating-on-battery.
European Union Representative
A system with this mark agrees with the
European Council Directive (93/42/EEC)
XXXX
for Medical Devices when it is used as
specified in the Operation and
Maintenance Manual. The xxxx is the
certification number of the Notified Body
used by Datex-Ohmeda’s Quality
Systems.
1605-0014-000 02/08/00
1-5
INOvent delivery system
Notes:
1-6
02/08/00 1605-0014-000
2/General Information
2
In this section
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Configuration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Main component views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Display and user controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Theory of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
NO Flow from the cylinder to the patient breathing
circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Effect of inserting the INOvent into a breathing
circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
1605-0014-000 02/08/00
2-1
INOvent delivery system
Overview
• The INOvent delivery system delivers nitric oxide therapy gas into
the inspiratory limb of the patient breathing circuit in a way that
provides a constant concentration of NO, as set by the user, to the
patient throughout the inspired breath.
• The INOvent delivery system uses a specially designed Injector
Module which enables the tracking of ventilator waveforms and the
delivery of a synchronized and proportional dose of NO.
• The INOvent delivery system may be used with most ventilators.
• The INOvent delivery system provides continuous on-line integrated
monitoring of delivered O
, NO
, and NO, and a comprehensive
2
2
alarm system.
• The interactive control panel and display provide a simple-tounderstand interface for operation of the INOvent delivery system.
• The battery system provides up to 30 minutes of uninterrupted nitric
oxide delivery in the absence of an external power source.
• The INOvent delivery system provides an integrated Manual NO
delivery system for administration of a fixed concentration of NO/O
therapy with a resuscitator bag.
2
2-2
02/08/00 1605-0014-000
Configuration Options
The INOvent delivery system is available in two configuration options:
• Shelf or table option and
• Mounted on a transport cart which holds two NO therapy gas
cylinders.
The options let you choose the setup which meets the needs of the
work environment.
2/General Information
1605-0014-000 02/08/00 2-3
INOvent delivery system
Main component views
8
7
6
5
1
2
1. Display and operating panel
2. Manual NO Delivery System Activity Indicator
3. NO/N2 Injector Tube connector
4. Injector Module Electrical Cable connector
5. Fluid Trap Bottle
6. Inspiratory Gas Sample Line connector
7. Inspiratory Gas Sample Line
8. Fluid Trap Filter Cartridge
Figure 2-1 • INOvent delivery system, front view
34
AA.69.034
2-4 02/08/00 1605-0014-000
2/General Information
1
2
3
4
15
14
13
12
11
10
1. NO Sensor
2. NO2 Sensor
3. Nurse Call connector
4. Serial Port connector
5. Power Entry Module
6. Power Cord connector
7. External Ground connection point
8. ON/STANDBY switch
9. Cooling Fan and Filter
10. O2 Sensor
11. Sample gas outlet
12. Regulator Low Pressure Hose with Quick Connector (2)
13. NO/N2 Input Hose Connector (2)
14. Resuscitator Bag O2 Tube connector
15. Connector to the O2 Flowmeter
5
6
7
8
9
AA.69.147
Figure 2-2 • INOvent delivery system, rear view
1605-0014-000 02/08/00 2-5
INOvent delivery system
4
1
23
1. NO/N2 injector tube connection to the INOvent delivery system
2. Inspiratory limb breathing circuit connection; to humidifier
3. Inspiratory limb breathing circuit connection; from ventilator
4. Electrical cable connection to the INOvent delivery system
Figure 2-3 • Injector Module, side view
AA.69.266
2-6 02/08/00 1605-0014-000
Display and user controls
The INOvent delivery system display and control panel has a control
wheel, buttons, and an easy-to-view electroluminescent display. All
the INOvent delivery system controls and monitoring are in one place
which reduces the need for extensive visual scanning.
The buttons and control wheel on the INOvent delivery system
control panel perform an assortment of functions and access various
features.
The steps for performing any operation, or accessing any function, on
the INOvent delivery system require the same interaction with the
control panel, namely:
1. Select (press) a button associated with the desired function or
operation,
2. Rotate the control wheel to select a menu item or value,
3. Confirm the selection by pressing either the control wheel or the
function button.
2/General Information
The control panel display, buttons and control wheel are used to:
• Set the concentration of delivered NO,
• Adjust alarms,
• Pause NO delivery,
• Silence alarms,
• Review alarm history,
• Define setup options,
• Calibrate the monitors.
A single tone indicates:
• Your choice of an action with a button or the control wheel,
• An invalid action with a button or the control wheel or
• A message box appearance on the display.
In normal operation, a typical display presents these major sources of
information:
• The Set NO value,
• The measured values of three inspired gases O
• Alarm information.
, NO2 and NO,
2
Menus guide you through the steps needed to deliver NO. Display
and user controls are also discussed in the sections of this manual
where system operations are explained.
1605-0014-000 02/08/00 2-7
INOvent delivery system
23
1
45
6
7
14
13
12
11
10
9
8
16
1. Alarm Silence button
2. Alarm Silenced Countdown Timer
3. Alarm message area
4. Alarm History indication are
5. Alarm History button
6. NO Bargraph
7. Control Wheel
8. Set NO button
9. Pause Flow button
10. Inspired NO Measured Value
11. Calibration button
12. Inspired NO2 Measured Value
13. Setup button
14. Inspired O2 Measured Value
15. Alarms button
16. Mains Power light
Figure 2-4 • User controls and indicators on the front
15
AA.69.034
Following are brief descriptions of display and user controls shown in
figure 2-4. See the other areas in the manual for more information.
1. Alarm Silence
button
2. Alarm Silenced
Countdown Timer
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Pushing the Alarm Silence button silences an audible alarm and
starts the alarm silence countdown timer in the upper left location of
figure 2-4 (item 2). The counter shows the remaining silence time. A
new alarm will sound even if the Alarm Silence function has
previously been activated.
The Alarm Silenced Countdown Timer shows a silenced bell and the
remaining silence time when the Alarm Silence button is pushed. The
timer counts down from 120 seconds to zero for high and medium
priority alarms.
2/General Information
3. Alarm message area The highest priority most recent alarm message appears in the top
part of this alarm message area first. On high priority alarms, the
elapsed-time counter counts up. Alarm messages are also
accompanied by audio signals. Refer to section 7/Alarms for
additional information on alarms.
4. Alarm History
indication area
This normally blank area displays “Alarm History” if there are resolved
alarms. See section 7/Alarms for information on resolved alarms.
5. Alarm History button Pushing the Alarm History button shows the Alarm History menu
listing the resolved alarms. There is an option to clear the displayed
resolved alarms.
6. NO Bargraph The NO Bargraph shows the Set NO value in ppm.
7. Control Wheel The Control Wheel’s function is defined by the information on the
display. When a menu is displayed, turning the wheel in either
direction selects a choice or adjusts device settings on the menu.
Pressing the wheel then selects the current menu item or confirms the
adjusted setting.
8. Set NO button Pushing the Set NO button allows adjustment of the Set NO bargraph.
9. Pause Flow button Pushing the Pause Flow button displays the “Pause Flow” message
box but does not pause the NO flow. To pause NO flow, you must
push the Pause Flow button a second time.
10. Inspired NO
Measured Value
The measured value of inspired NO (in ppm) is displayed in large
numbers. Low and high alarm settings for inspired NO appear below
these numbers.
11. Calibration button Pushing the Calibration button displays the menu for calibrating the
high and low range of the sensors. Refer to section 4/Calibration for
information on calibration.
12. Inspired NO
Measured Value
The measured value of inspired NO2 in ppm is displayed in large
2
numbers. The high alarm setting for inspired NO2 appears below
these numbers.
13. Setup button Pushing the Setup button displays the Setup menu for setting the
alarm volume and display brightness or returning to the normal
display. See section 3/Setup and Calibration for additional
information.
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INOvent delivery system
14. Inspired O2 Measured
Value
The inspired O2 measured value in % is displayed in large numbers.
The low and high alarm settings for inspired O2 appear below these
numbers.
15. Alarms button Pushing the Alarms button displays the menu for setting the user-
adjustable alarm limits. High limits can be set for O2, NO2 and NO.
Low limits can be set for O2 and NO. See section 7/Alarms for
additional information on alarms.
16. Mains Power light When the green Mains Power light is on, the system is connected to a
functioning mains power outlet.
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2
Theory of Operation
I
S
The INOvent delivery system delivers nitric oxide therapy gas into the
inspiratory limb of the patient breathing circuit in a way that provides a
constant concentration of NO to the patient throughout the inspired
breath.
The INOvent delivery system uses a specially designed Injector
Module which enables the tracking of ventilator waveforms and the
delivery of a synchronized and proportional dose of NO.
2/General Information
NO Flow from the
Cylinder to the
Patient Breathing
Circuit
nspired Gas
ample Port
Cells
Sample
O2
Pump
NO
2
NO
Monitoring
and
Alarm Board
Controls and Display
Cylinder
Controller
Board
High Pressure
Regulator
Pressure
Switch
Quick Connectors
Low Pressure
Regulator
Shut Off Valve
Flow
Controllers
AA.69.121
Injector
Module
Nitric Oxide
Sample Gas
Electronic
Figure 2-5 • NO Flow from the cylinder to the patient breathing circuit
See figure 2-5.
Nitric oxide therapy gas is stored as a gas mixture (Nitric Oxide [NO]
and Nitrogen [N2] balance gas) in an aluminum cylinder at a maximum
pressure of 2200 psi. When the cylinder valve is opened, nitric oxide
therapy gas is regulated down by a high pressure NO regulator.
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INOvent delivery system
The regulator has a safety relief valve which opens if the regulator
malfunctions. The regulator also has a supply pressure gauge which
indicates the pressure in the cylinder.
Regulator and gauge location varies with the INOvent delivery system
configuration option chosen. Each INOvent delivery system has two
sets of regulators and gauges.
The nitric oxide therapy gas enters the INOvent delivery system
through the NO/N
input hose connectors (quick-connects.) When the
2
gas enters the INOvent delivery system, a pressure switch monitors if
adequate pressure is available.
A low pressure regulator reduces the pressure to a nominal 26 psi.
The output of this regulator supplies a shut-off valve where it waits for
a delivery demand from the user.
When the shut-off valve is opened, NO flows through one of two flow
controllers: a high flow or a low flow controller. The high and low flow
controllers ensure accurate delivery of nitric oxide therapy gas over a
wide range of ventilator flow rates and desired NO concentrations.
Nitric oxide therapy gas is introduced into the inspiratory limb of the
breathing circuit through the INOvent Injector Module. The Injector
Module must be between the ventilator and the humidifier chamber.
Nitrogen dioxide (NO
), an unwanted by-product of mixing NO and O2,
2
is reduced by injecting the nitric oxide therapy gas downstream of the
ventilator.
The Injector Module uses an integrated respiratory flow sensor to
measure ventilator flow rate in the breathing circuit inspiratory limb.
This lets the INOvent delivery system track ventilator waveforms and
inject a synchronized and proportional flow rate of NO. This supplies a
constant concentration to the patient.
The INOvent delivery system “dual-channel” design ensures safe
delivery of nitric oxide therapy gas. One channel has the delivery
components: controller board, flow controllers, and injector module.
The other channel has the monitoring components: monitor and alarm
board, monitor sensors (NO, NO
, and O2 cells) and inspired-gas
2
sample system.
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2/General Information
2
The dual-channel approach to delivery and monitoring permits
delivering NO independent of monitoring if the monitor malfunctions.
The INOvent delivery system also has the safety features of an
integrated system such as automatic shutdown if the NO monitored
value becomes greater than 100 ppm.
When nitric oxide therapy gas delivery is required, the user selects
the desired NO dose level in parts per million (ppm.)
The INOvent delivery system processes both the desired level for NO
delivery as well as the instantaneous patient circuit flow from the
INOvent Injector Module. Using this information, the INOvent delivery
system injects the proportional amount of NO necessary to deliver a
constant concentration throughout the breath.
The INOvent delivery system tracks ventilator waveforms and injects
a synchronized, proportional, flow of NO into the inspiratory limb of
the breathing circuit. This delivers a constant concentration of NO to
the patient, independent of ventilator modes and flow rates as shown
in figure 2-6.
Figure 2-6 • INOvent delivery system injection method: a constant NO
concentration
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AA.69.120
INOvent delivery system
Effect of inserting the
INOvent into a
breathing circuit
There are two main effects of connecting and using the INOvent
delivery system in a ventilator breathing circuit.
First, the INOvent delivery system adds gas to the breathing circuit in
proportion to the NO setting. For example, at an 80 ppm NO setting
(the maximum NO setting with a 800 ppm NO cylinder concentration),
the INOvent delivery system adds 10% more gas to that delivered by
the ventilator, 5% more for a 40 ppm setting, etc.
Second, the INOvent delivery system subtracts gas from the
breathing circuit via the gas sampling system at a nominal flowrate of
230 mL/min.
These two effects of adding and subtracting gas from the ventilator
breathing circuit have the following effects.
Oxygen Dilution The INOvent delivery system adds gas to the breathing circuit in
proportion to the NO setting as described above. The gas being
added by the INOvent delivery system is a mixture of NO with the
Volume Control
Ventilation
balance gas being Nitrogen (N
the breathing circuit gas is reduced because of the NO/N2 injection.
This reduction is proportional to the NO setting. At an NO setting of 80
ppm with a cylinder concentration of 800 ppm NO, the added gas is
10%. Thus, the O
value. For example, if the original O2 concentration was 50% v/v, then
the value after injection, at the 80 ppm setting, is 45% v/v.
When using volume control ventilation with the INOvent delivery
system, the measured tidal volume delivered to the patient shows
small changes depending on the NO setting being used. Some minor
ventilator adjustments may be required to the volume setting to
compensate for this addition and subtraction of gases.
For example, assume a respiratory rate of 20 bpm and a tidal volume
of 500 mL. The reduction in tidal volume due to the sampling system
is 230 / 20 bpm. This is approximately 10 mL per breath. The increase
in tidal volume due to an NO setting of 80 ppm with a cylinder
concentration of 800 ppm is 10% of 500 mL. This is 50 mL per breath.
Thus, the total effect on the delivered tidal volume is between -10 mL
to +40 mL for an NO set range between 0 to 80 ppm.
concentration is reduced by 10% of its original
2
.) Thus, the oxygen concentration in
2
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2/General Information
2
Pressure Control
Ventilation
In pressure control ventilation there are no significant effects of the
INOvent delivery system on the pressures in the breathing circuit and
hence to the tidal volume being delivered to the patient. This is
because the ventilator actively controls the pressure in the breathing
circuit and makes adjustments to compensate for the effect of the
INOvent delivery system.
However, if a ventilator has inspired tidal volume measurement which
is monitored inside the ventilator, this measurement reflects the
change in the ventilator gas flow necessary because of the effect of
the INOvent delivery system.
For example, assuming a respiratory rate of 20 bpm and a tidal
volume of 500 mL, the net effect on the inspired tidal volume is -40 mL
to +10 mL for an NO set range of 0 to 80 ppm.
Trigger Sensitivity The addition and subtraction of gases by the INOvent delivery system
may effect the trigger sensitivity of the ventilator when using
synchronize modes of ventilation.
In ventilators which have flow trigger modes where the trigger flow is
set to less than 1 L/min, this may cause the ventilator to auto-trigger.
The trigger sensitivity of the ventilator should be checked after
connecting the INOvent delivery system.
High Frequency
Oscillatory Ventilator
Circle Anesthesia
Ventilator Systems
The effect of the INOvent delivery system on a High Frequency
Oscillatory Ventilator (HFOV) is minor changes to the bias flow
because of the gas sampling system and the addition of gas flow in
proportion to the NO setting.
For example, with a bias flow of 10 L/min, the reduction in bias flow
due to the sampling system is 0.23 L/min. The increase in bias flow
due to an NO setting of 80 ppm with a cylinder concentration of 800
ppm is 10% of 10 L/min which is 1 L/min. Thus, the bias flow will vary
between 9.77 and 10.77 for an NO set range between 0 to 80 ppm.
The effect of the INOvent delivery system on circle anesthesia
ventilator systems which use volume control ventilation is to cause
small changes in the tidal volume being delivered to the patient
depending on the NO setting being used. Minor changes to the
volume setting on the ventilator may be necessary to compensate for
this addition and subtraction of gases.
For example, assume a respiratory rate of 10 bpm and a tidal volume
of 500 mL.
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INOvent delivery system
The reduction in tidal volume caused by the sampling system is 230 /
10 bpm. This is approximately 20 mL per breath. The increase in tidal
volume caused by an NO setting of 40 ppm with a cylinder
concentration of 800 ppm is 10% of 500 mL. This is 50 mL per breath.
Thus, the total effect on the delivered tidal volume is between -20 mL
to +30 mL for an NO set range between 0 to 80 ppm.
Recirculation of gases in circle breathing systems should be avoided
to ensure that the accumulated gases in the ventilator bellows are not
introduced into the inspiratory limb of the breathing circuit. The gas in
the ventilator bellows may contain undesirable levels of NO
and other
2
reaction products that may not be removed by the absorbent when it
contains appreciable moisture as might occur in typical use.
Recirculation of gases can be avoided by using fresh gas flowrates
equal to a patient’s minute volume. This can be explained as follows.
During the expiratory phase of the breathing cycle, the fresh gas from
the common gas outlet enters the absorber and flows in the reverse
direction displacing some of the expired gas that is present.
During the next inspiratory phase, the accumulated gas in the
ventilator bellows displaces the fresh gas in the absorber, pushing it
into the inspiratory limb where it mixes with the fresh gas from the
common gas outlet and flows to the patient.
As long as the fresh gas flow is equal to or greater than the patient’s
minute volume, there is sufficient fresh gas in the absorber such that
no accumulated gas from the ventilator bellows reaches the
inspiratory limb of the breathing circuit and hence to the patient.
Maximum NO Delivery The INOvent delivery system is limited to a maximum NO flow of 6.2
L/min. This means the maximum deliverable NO concentration will
vary based on the ventilator flow rate.
Figure 2-7 illustrates the maximum deliverable NO concentration
versus constant inspiratory flow rate (for an 800 ppm cylinder
concentration). The graph depicts the decrease in maximum
deliverable concentration by the INOvent delivery system as a
function of constant inspiratory flow rate.
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