Datex-Ohmeda INOvent User and maintenance manual

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INOvent delivery system

Operation and Maintenance Manual

CGA Variant

Page 2

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

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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

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Calibration information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

NO, NO

And O

calibration (daily, room air) . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

And O

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Sensor low range

Sensor high range calibration . . . . . . . . . . . .4-5

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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

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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

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

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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

02/08/00 1605-0014-000

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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

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INOvent delivery system

Notes:

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Introduction

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

1605-0014-000 02/08/00

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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.

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

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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.

: Nitrogen.

NO: Nitric oxide.

: Nitrogen dioxide.

NO/N

: Nitric oxide (NO) and nitrogen (N

) gas mixture.

Numeric area: Area in the display where values and settings

are shown.

: Oxygen.

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

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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.)

Off.

Standby.

Alternating current.

∏

Protective earth ground.

Earth ground.

Alarm Silence.

Equipotential.

Plus, positive polarity.

≈

REF

This way up.

Dangerous voltage.

Input.

Output.

Stock number.

Serial number.

Sample gas outlet.

Sensor connector.

Manual delivery system.

NO/O

1-4

Minus, negative polarity.

Sensor.

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Movement in one direction.

NO Sensor.

Introduction

134°C Autoclavable.

Not autoclavable.

Type B equipment.

Type BF equipment.

Warning and Caution symbol.

Attention, consult accompanying documents, IEC 601-1.

Sensor.

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

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INOvent delivery system

Notes:

1-6

02/08/00 1605-0014-000

Page 15

2/General Information

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

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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

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

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Page 17

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

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INOvent delivery system

Main component views

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

AA.69.034

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2/General Information

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

7 8

AA.69.147

Figure 2-2 • INOvent delivery system, rear view

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INOvent delivery system

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

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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,

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.

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INOvent delivery system

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

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

2-8 02/08/00 1605-0014-000

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.

Page 23

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

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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Page 25

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

Pump

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

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,

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

sample system.

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2/General Information

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

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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

.) Thus, the oxygen concentration in

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2/General Information

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

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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2/General Information

The INOvent delivery system will deliver a maximum concentration of 80 ppm (using 800 ppm cylinder concentration) up to an inspiratory flow rate of 55 L/min. As inspiratory ventilator flows increase, the maximum deliverable NO concentration decreases gradually until the inspiratory flow rate reaches 120 L/min. The maximum deliverable NO concentration at 120 L/min (using 800 ppm cylinder concentration) is 40 ppm. The NO flow rate for a constant inspiratory flow rate can be calculated from the following formula:

(NO ) x (Fresh gas flow rate)

set

(Cylinder concentration) - (NO )

set

When intermittent inspiratory flow rates are used, peak ventilator flows may be attained which exceed the INOvent flow rate specification of 120 L/min. Peak inspiratory flow rates are transient and extremely short in duration. As a result, the portion of the breath which is not matched by the INOvent delivery system is extremely small and virtually negligible with respect to the entire range of the breath.

200 40 60 80 100 120

1. Maximum deliverable NO concentration (ppm)

2. Constant inspiratory ﬂowrate (L/min)

AA.69.193

Figure 2-7 • Maximum deliverable NO concentration vs. constant

Inspiratory flow rate

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INOvent delivery system

Notes:

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Page 33

3/Setup

In this section This section provides connection information for the INOvent delivery system.

INOvent 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

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INOvent delivery system

INOvent delivery system connections

See ﬁgures 2-1 or 2-2 if you need to identify additional parts.

Mounting

Refer to the following mounting instructions:

• when first using the system or

• when installing a replacement system.

Cart mounting If the optional transport cart is used, the INOvent delivery system

must be properly mounted and secured to the cart before making system connections. See ﬁgure 3-1.

1. Place the INOvent delivery system on the cart top shelf with the four mounting feet inserted into the four mounting slots.

• Make sure the INOvent delivery system is pushed to the back and is against the shelf backstop.

2. Tighten the mounting screw at the back of the cart top shelf to attach the INOvent delivery system.

1. System mounting feet (4)

2. Cart top shelf

3. Mounting slots on cart top shelf (4)

4. Shelf backstop

5. Mounting screw

Figure 3-1 • Cart mounting

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AA.69.034

AA.69.037

Page 35

3/Setup

Shelf or table mounting Place the INOvent delivery system on the shelf or table where it will

be used.

• Allow safe and convenient routing for nitric oxide and therapy gas hoses.

System connections

Important To remove this type of hose connector, pull the widest part of the

connection away from the back of the system until the hose connection releases. You can then pull the hose connector out.

1. Remove all protective caps from the connectors and ports on the INOvent delivery system.

See figure 3-2.

2. Connect the low pressure NO/N

hose from the regulator to the

back of the INOvent delivery system by inserting until the red sleeve pops into place.

AA.69.147

5 6

1. Regulated low pressure NO/N

hose connectors (2)

2. Cylinder gauge boot (2)

3. Regulator low pressure NO/N

hoses (2)

4. Regulator high pressure hoses (2)

5. Gas cylinder (2)

6. Dovetail rail (2)

Figure 3-2 • System connections

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AA.69.037

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INOvent delivery system

wwwwCAUTION Make sure the cart is stable after the accessories are attached.

3. Check the therapy gas cylinders for the correct product identity labels and NO concentration. The NO concentration must match that shown in the Setup menu for Cylinder Concentration. For additional cylinder information see section 13/Appendix B Cylinder Information.

4. If necessary, attach the cylinder gauge boots to the gauges on the front of the cart by pressing the boots into the gauge openings. Gauge boots are shown in figure 3-2.

5. If a cart is used, lock accessory supports into the dovetail rail before attaching accessories. Place heavier accessories near the base of the cart.

• Make sure that any load is evenly distributed to help maximize stability when the system is moved.

6. Place the cart where it will be used and push down on the wheel locks with your foot to lock the casters. To unlock a caster, push down on the opposite end of the wheel lock.

wwwwCAUTION Do not lean on, or lean anything against, the cart.

7. Connect and tighten the fittings on the high pressure hose from the regulator to the NO therapy gas supplies. Refer to figure 3-3.

a. Make sure the hose tip or seal is in place and not damaged

when connecting to the cylinders.

b. Note: over-tightening a fitting can reduce the useful life of the tip.

• Section 13/Appendix B - Cylinder Information has information on cylinders and leak checks.

1. High pressure hose fitting (CGA type)

2. High pressure hose fitting tip

3. High pressure hose from the regulator

4. Therapy gas cylinder

AA.69.132, AA.69.141

Figure 3-3 • Cylinder connections

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3/Setup

8. Make sure two NO gas cylinders, with more than 200 psi in each cylinder, are available.

9. Empty and clean the fluid trap bottle (figure 3-4) before each patient and whenever the trap is more than half full. See “Emptying the Fluid Trap” in section 6/Maintenance.

10.Connect the inspiratory gas sample line (figure 3-4) to the inspiratory gas sample line connector.

AA.69.034

1. Fluid trap bottle

2. Inspiratory gas sample line connector

Figure 3-4 • Fluid trap bottle and inspiratory gas sample line connector

11.Check that the three sensors (NO, NO

and O2) are installed on the

back of the INOvent delivery system. The O2 sensor has a short cable which must be plugged into the sensor and into the back of the system. See section 9/Maintenance for sensor installation information.

1. NO sensor sensor

2. NO

sensor

3. O

4. Short cable for O2 sensor

AA.69.147

Figure 3-5 • Sensor items

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INOvent delivery system

12.Connect either end of the Injector Module electrical cable to the

Injector Module as shown in figure 3-6.

• Align the connector before pushing the connector firmly into place.

• A keyway is identified by a red dot on both the connector and the Injector Module.

13.Connect the NO/N

Injector Tube to the Injector Module. See figure

3-6.

Important To remove this type of electrical connector, the knurled sleeve on the

connector must be pulled outward before removing the connector from the Injector Module or the front panel.

1. Electrical cable to the delivery system

2. NO/N

Injector Tube to the delivery system

Figure 3-6 • Injector Module connections

14.Connect the other end of the Injector Module electrical cable to the front of the INOvent delivery system.

• A keyway is identified by a red dot on the connector and on the front panel.

15. Connect the other end of the NO/N

Injector Tube to the front of the

INOvent delivery system.

AA.69.024

16.Tie the NO/N

Injector Tube to the Injector Module electrical cable

using hose clips as shown in figure 3-7.

1. Injector Module Electrical Cable

2. Hose Clip

3. NO/N

Injector Tube

Figure 3-7 • Hose clip connection

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AA.69.034

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3/Setup

Note: The Injector Module is inserted later into the inspiratory limb to measure the ventilator ﬂow rate and inject the therapy gas.

Figure 3-8 shows a typical system connection diagram.

54321

15 14 13 12 11 10 9

1. Patient wye

2. Ventilator

3. Ventilator Expiratory port

4. Ventilator Inspiratory port

5. Patient gas sample line input connection

6. INOvent delivery system

7. NO/N

Injector Tube front panel connection

8. Injector Module Cable front panel connection

9. Injector Module Electrical Cable connection

10.NO/N2 Injector Tube connection

11.Humidifier inlet

12.Humidifier

13.Humidifier outlet

14.Patient Gas sample line connection

15.Sample Tee

AA.69.017

Figure 3-8 • Typical system connection diagram (ICU ventilator)

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INOvent delivery system

Electrical connections

1. If you are using a nurse call system, refer to your nurse call system operation manual for the proper connection procedure. Connection is to the Nurse Call connector on the back of the INOvent delivery system.

• See section 12/Appendix A - Specifications for Nurse Call connector information.

wwwwCAUTION The correct AC line voltage for your local area must appear in the Power

Entry Module window on the back.

2. Check that the correct AC line voltage appears in the Power Entry Module window on the back: 100V, 120V, 220V or 240V, whichever is appropriate for your local voltage.

• If the voltage shown is not correct, see “Fuse Replacement and Line Voltage Selection” in section 10/Maintenance to set the voltage selection to the correct local voltage.

1. Power Entry Module window

Figure 3-9 • Power Entry Module window

3. Connect the power cord to the INOvent delivery system (see figure 3-10) and tighten the power cord clamp screws using a #1 Phillips screwdriver.

AA.69.267

1. Power cord clamp screws

2. Power cord

Figure 3-10 • Power cord and clamp

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3/Setup

4. Connect the INOvent delivery system power cord to an emergencypower-backed hospital-grade outlet.

• The front panel green Mains Power light must light to indicate that line voltage is present.

• The power cord must always be connected to an electrical outlet to maintain a full battery charge.

5. Switch the ON/STANDBY control to ON. (The system may take a minute before operation.)

• The Power-ON display (figure 3-11) appears during self-tests followed by a typical display as shown in figure 3-12.

Figure 3-11 • Power-ON display

Figure 3-12 • Typical display

SCR_1.tif

510k_2.tif

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INOvent delivery system

Setup menu

The Setup menu lets you change alarm volume and display brightness. You can view, but not change, the software revision, NO cylinder concentration conﬁguration and hourmeter.

Push the Setup button to see the Setup menu (shown in ﬁgure 3-13).

Cylinder

concentration

Hourmeter display

To set the alarm

loudness

The INOvent delivery system is factory-set for an 800 ppm cylinder concentration. This set concentration is indicated in the Setup menu. Alternate cylinder concentrations may be available by a special request to Datex-Ohmeda. See 17/Appendix F.

When connecting an NO cylinder to the INOvent delivery system, always check to see it is the same concentration for which the system is conﬁgured as appears in the setup menu.

The Power-ON display (ﬁgure 3-11) and the Setup menu (ﬁgure 3-13) provide an hourmeter indication which can be used for maintenance and service purposes. The hourmeter counts the hours when the ON/ STANDBY switch is in the ON position.

1. Push the Setup button to see the Setup menu.

2. Turn the control wheel to highlight the Alarm Loudness value (shown in figure 3-13.)

Figure 3-13 • Setup menu - Alarm Loudness level highlighted

3. Push the control wheel to confirm the Alarm Loudness level selection. Figure 3-14 shows the same level in a selection box after pushing the control wheel.

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510k_9.tif

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3/Setup

510k_10.tif

To set the display

brightness

Figure 3-14 • Select menu - Alarm Loudness level selected for

adjustment

4. Turn the control wheel to indicate the loudness level you want. Choices range from 1 (softest) to 5 (loudest.)

5. Push the control wheel to confirm your selection.

6. If you are finished with the Setup menu, turn the control wheel to select Exit to Normal Display.

• If you want to set the display brightness, continue with step 2 of “To set the display brightness.”

7. Push the control wheel to exit.

1. Push the Setup button.

2. Turn the control wheel to highlight the Display Brightness level on the Setup menu.

3. Push the control wheel to confirm the display brightness level for change.

4. Turn the control wheel to show the level you want. Choices range from 1 (darkest) to 10 (brightest.)

5. Push the control wheel to confirm your selection.

6. If you are finished with the Setup menu, turn the control wheel to select Exit to Normal Display. Push the control wheel to exit.

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INOvent delivery system

Notes:

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Page 45

4/Calibration

In this section This section describes how to calibrate the NO, NO

calibration is needed. For example:

• after replacing a sensor,

• during Pre-Use Procedures,

• Monthly System Checkout or

• when messages ask you to do so (i.e., “Calibration Due”.)

Calibration information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

NO, NO

(daily, room air). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

NO, NO

and O2 Sensor low range calibration

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

and O2 Sensor high range calibration . . . . . . . . . . . .4-5

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

and O2 sensors when

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INOvent delivery system

Calibration information

wwwwCAUTION Calibrate only with the correct calibration gas.

Make sure that the calibration gas expiration date is still

valid.

Calibrate the sensors in the environment in which they will

be used: for example, in the ICU.

NO therapy can be administered during the sensor calibration process but inspired gases are not monitored and gas monitoring alarms are disabled.

The ventilator settings must not be changed during sensor calibration or an alarm condition may occur.

You calibrate the low ranges of the three sensors at the same time using room air.

The high ranges must be calibrated using their respective NO and NO

calibration gases and O2 using a medical grade 100% O2 from a

wall or cylinder source.

The calibration process can be stopped at anytime by pushing the control wheel to cancel an operation or to exit to a normal display. Also, calibration can be stopped by selecting another control button (for example, Pause Flow.)

If calibrations fail, see the 9/Troubleshooting section in this manual.

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4/Calibration

NO, NO2 and O2 Sensor low range calibration (daily,

room air)

Procedure

Use the Calibration menus to calibrate the low range of the three gas sensors (NO, NO2 and O2) at the same time using room air; the calibration may take up to ﬁve minutes.

NO, NO2 and O2 room air levels are displayed during low range calibration and trend toward 0 ppm, 0 ppm and 21% respectively.

1. From a normal display with the INOvent delivery system operating, push the Calibration button to reach the first Calibration menu. It shows the Low Range (room air) “NO, NO highlighted (figure 4-1).

and O2” option

Figure 4-1 • Calibration menu - low range sensor calibration option

2. Push the control wheel to start the low range calibration. All three sensors calibrate automatically at the same time. The display in figure 4-2 appears during the calibration. Calibration may take a few minutes.

• The sample line does not have to be disconnected to do this step. The system draws in room air from within the system enclosure through an NO/NO

highlighted

scrubber.

510k_11scr_12

Figure 4-2 • Calibration menu - low range sensor calibration in

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INOvent delivery system

3. When the calibration is successful, the display in figure 4-3 appears.

• If calibration is unsuccessful for any of the sensors, an appropriate message as in figure 4-4 is displayed. In this case follow the instructions on the display.

• You may turn the control wheel to “Exit to Normal Display” or continue on to “High range calibration (calibration gas.)”

510k_13510k_14

Figure 4-3 • Calibration menu - low range calibration completed

Figure 4-4 • Calibration menu - NO low range calibration failed

4. To continue on to “High range calibration (calibration gas),” turn the control wheel to select “Go to Calibration of Sensors.”

5. Push the control wheel to accept “Go to Calibration of Sensors” and continue with the following steps.

4-4 02/08/00 1605-0014-000

Page 49

NO, NO2 and O2 Sensor high range calibration

wwwwCAUTION Never connect the sample line directly to a high pressure source. This

could damage the sampling system.

4/Calibration

Procedure

Use the Calibration menus to calibrate the high range of the NO, NO and O2 sensors.

Procedures for high range calibration of the three sensors are essentially the same as for the low range, but a different calibration gas is used for each sensor. Calibration must be done individually:

• NO and NO

each with their respective NO and NO2 calibration

gases,

•O

with a medical grade 100% O2 from a wall or cylinder source.

Note: Contact the drug supplier for NO and NO

calibration gases.

1. To calibrate the NO or NO2 sensor high range: connect the calibration gas for the sensor you are calibrating as shown in figure 4-5. When calibrating NO, connect NO calibration gas; when calibrating NO

, connect NO2 calibration gas. Then, go to step 3.

1. Calibration gas cylinder pressure gauge

2. Sample Line

3. One-way valve

4. Vent to atmosphere or scavenge - Do not occlude

5. Cylinder ON/OFF control

6. NO or NO

Figure 4-5 • Connection diagram for NO and NO

1605-0014-000 02/08/00 4-5

calibration gas cylinder

calibration

high range

AA.69.110

Page 50

INOvent delivery system

2. To calibrate the O2 sensor high range, connect the O2 calibration gas as shown in figure 4-6. Then, go to step 3.

O2 to the

123

100% O

Flowmeter Sample Tee

Sample System

To the

Atmosphere

AA.69.260

1. 100% O

2. Flowmeter

3. Sample Tee

4. O2 to the Sample System

5. INOvent delivery system Sample Line

6. To the atmosphere

Figure 4-6 • Connection diagram for O

high range calibration

3. On the Calibration menu) turn the control wheel to highlight the NO,

or O2 selection of “High Range (cal. gas).” Example shown in

figure 4-7.

Figure 4-7 • Calibration menu - high range NO sensor calibration

option highlighted

4. Make sure that the calibration gas cylinder ON/OFF control is turned OFF.

5. Attach the system sample line to the calibration gas source.

6. Turn the calibration gas source ON.

4-6 02/08/00 1605-0014-000

scr_11b

Page 51

4/Calibration

7. Push the control wheel to start the high range calibration of the selected sensor. A display similar to figure 4-8 appears.

8. Follow the instructions given on the display. These instructions are shown here:

• 1. Flow NO [NO

or 100% O2] calibration gas into the sample line.

• 2. Wait for “Measured NO, NO2 or 100% O2” to stabilize.

(Note: The “Measured” value is the monitored value of the calibration gas during sampling. This value updates continuously during the calibration process. After the “Measured” value has stabilized, push the control wheel.)

• 3. Set “Calibration XX” to cal. gas value.

(Select “Calibration XX.” Then, turn the control wheel to set the value to that marked on the calibration gas cylinder label [or 100% for 4-8 shows the “Calibration NO” value set to match a calibration gas cylinder label value of 45 ppm.) Then, push the control wheel to enter. “In Progress...” will be shown on the Calibration NO line as in figure 4-9.

.] Figure

510k_15510k_16

Figure 4-8 • High range calibration menu example - Calibration NO

adjusted to 45 ppm

Figure 4-9 • High range calibration menu example - Calibration NO “In

Progress” highlighted

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INOvent delivery system

9. If the high range calibration fails, follow the instructions given on the display (shown in figure 4-10).

510k_17

Figure 4-10 • High range calibration menu example - NO high range

calibration failed

10.When the current sensor calibration is finished, select “Go to Calibration of Sensors” and push the control wheel.

11.When the “Calibration of Sensors” display appears, select the next sensor for calibration.

If you are ﬁnished with all three sensor calibrations:

12.Select “Exit to Normal Display” and push the control wheel.

13.Turn the calibration gas cylinder ON/OFF control to OFF.

14.Reconnect the sample line to the breathing circuit.

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Page 53

5/Pre-Use Procedures

Important The Pre-Use Procedures consist of three tests

which must be done before delivering NO therapy to a patient:

1. Initial connections and leak test.

2. System purge and performance test.

3. Manual NO delivery system purge and performance test.

These Pre-Use Procedures are for 800 ppm concentration conﬁgurations only.

In this section 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

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INOvent delivery system

1. Initial connections and leak test

1. If necessary, connect the INOvent delivery system as described in section 3/Setup.

2. Check the cables and hoses for signs of wear or damage and replace as needed.

3. Turn the INOvent delivery system ON and confirm that the buzzer and the speaker sound. Wait for the start-up routine to finish. (The Power-ON display appears during self-tests followed by a normal display.)

4. Confirm from your records that a Monthly System Checkout has been done in the last month. If it hasn’t, do a Monthly System Checkout. See section 10/Maintenance.

5. Do a system high pressure leak test.

a. With the INOvent delivery system ON, turn each cylinder valve

ON then OFF. Check for adequate cylinder pressures. Wait for 30 seconds and check for pressure decrease.

b. If there is any decrease, make sure that the auxiliary oxygen

flowmeter to the Manual NO System is not turned on and check for leaks around the hose connections using soapy water.

c. Check for leaks at the NO cylinder valve outlet connection using

soapy water.

Note: The pressure drop leak test will not detect leaks at the cylinder valve outlet connection because of the check valve in the regulator hose. See 13/ Appendix B - Cylinder Information if you suspect a leak.

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Page 55

2. System purge and performance test

5/Pre-Use Procedures

wwwwWARNING Make sure a purge has been completed within five minutes before the

start of NO therapy. If not, repeat the performance test as described here, making sure the NO

is less than the value listed for the cylinder

concentration being used.

1. Connect the Injector Module to an O

auxiliary flowmeter using O2

tubing, a 4.5 mm to 15 mm adapter and a breathing circuit adapter to condition the flow before the Injector Module. See figure 5-1.

2. Connect a sample tee to the outlet of the injector module with 300 mm of 22 mm hose to ensure gas mixing prior to gas sampling (see figure 5-1.) Attach a sampling line from the sample tee to the sample connector on the front panel.

910

34 5 6 7

Flowmeter

AA.69.032

2O2 Tubing 3 15M x 4.5 mm Adapter 4 22M / 15F x 22M / 15F Adapter 5 Injector Module 6 300 mm of 22 mm hose 7 Sample Tee 8 Inspiratory Gas Sample Line 9 NO/N

Injector Tube

10 Injector Module Electrical Cable

Figure 5-1 • Circuit connections for purge and performance test

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INOvent delivery system

3. Do a low range calibration of the NO, NO2 and O2 monitors. (See section 4/Calibration.)

4. Make sure both NO cylinders are turned off after being turned on.

5. Set the oxygen flow to 15 L/min and the Set NO concentration to its maximum setting.

6. Make sure both cylinder high pressure gauges go to zero to purge both high pressure circuits.

7. Check that the NO NO

monitor is functional and

value is higher than 0.2 ppm to verify that the

8. Make sure these two alarms occur:

• Low NO/N2 Pressure”

• Delivery Failure”

(This may take a few minutes depending on the cylinder pressures at the start of the test.)

9. When the alarms have occurred, turn on the NO cylinder with which you intend to start therapy. Leave the other cylinder turned off.

10.Set the O2 flow on the auxiliary flowmeter to 15 L/min and the Set NO to 40 ppm.

a. Wait for 3 minutes or until the monitor readings are stable.

b. Make sure that the O

, NO2 and NO readings are within the

acceptable ranges given below.

Note: These acceptable readings include the errors of the NO delivery system and the NO therapy gas.

O2 %v/v

(±3 %v/v)

NO2 ppm

(max)

NO ppm

(min/max)

Set NO = 40 ppm: 95 1.5 32/48

11.Do the monitor high range calibrations if required.

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Page 57

5/Pre-Use Procedures

3. Manual NO delivery system purge and performance test

wwwwWARNING The Manual NO delivery system must be set up and available at all times.

The Manual NO delivery system must be configured as shown in figure 8-2.

Do not connect an O the rear of the INOvent delivery system.

wwwwCAUTION Supplemental O

delivery system is in use.

1. Connect the Manual NO delivery system as described in section 3/ Setup.

2. Disconnect the resuscitator bag. Connect the 22 mm / 15 mm sample tee (with the sample line connected) to the oxygen tubing using a 15M x 4.5 mm adapter. See figure 5-2.

supply, wall or cylinder, directly to the O2 inlet on

should only be turned on and used when the manual

}

98 7

1 Inspiratory Gas Sample Line 2 Oxygen tubing (user supplied) 3 NO/O 4O 5O 6 Pressure Compensated O

7 NO/N 8 15M x 4.5 mm Adapter 9 Sample Tee

outlet

inlet

supply hose from the O2 flowmeter

flowmeter (user supplied), shown set to OFF

(no float activity)

input hoses from the regulators

Figure 5-2 • Sample tee connection to the Manual NO delivery system

1605-0014-000 02/08/00 5-5

AA.69.160

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INOvent delivery system

3. Flow 15 L/min of O2 from the auxiliary O2 flowmeter into the Manual delivery system and make sure the float moves to the middle of the NO Flow Indicator Window.

4. Wait for the gas to flow through the oxygen tubing. Make sure that the NO reading is 20 ± 8 ppm and the NO2 reading is less than 1.0 ppm. If the NO2 reading is greater than 1.0, continue flowing gas until the limit is reached.

Note: These acceptable readings include the errors of the NO delivery system and the NO therapy gas.

5. Reduce the O2 flow to 1 L/min and make sure that the float drops to the bottom of the NO Flow Indicator.

6. Set the O

4.5 mm adapter from the oxygen tubing.

7. Reconnect the resuscitator bag to the oxygen tubing.

flow to zero and disconnect the sample tee and 15M x

- End of the Pre-Use Procedures -

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Page 59

6/Operation

wwwwWARNING Use only “Latex-Free” breathing circuits and ventilators when using the

INOvent delivery system.

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.

Make sure a purge has been completed within ﬁve minutes before the start of NO therapy. If not, repeat the performance test as described in section 5/Pre-Use Procedures making sure the NO listed for the cylinder concentration being used.

Set the INOvent delivery system alarm thresholds for the current patient conditions to monitor any inadvertent changes in treatment. For alarm information, see section 7/Alarms.

Be certain all cables and hoses are positioned to help prevent damaging or occluding them.

Patient disconnect and high pressure alarms are required for the ventilator.

is less than the value

wwwwCAUTION Use distilled water in the humidifier to prevent the formation of bases or

acids.

In this section This section 6 provides information for connecting and operating the INOvent

delivery system in patient breathing circuits

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

Electronic delivery shutdown . . . . . . . . . . . . . . . . . . . . . . . 6-28

Monitoring the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29

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Page 60

6-2

INOvent delivery system

Before operation

1. Before operating the INOvent delivery system in the ventilator patient breathing circuit, make sure the Pre-Use Procedures of section 5 have been completed. The procedures include:

• Initial connections and leak test.

• System purge and performance test.

• Manual NO delivery purge and performance test.

2. Make sure the NO therapy gas cylinder pressure gauge shows an adequate cylinder supply pressure.The cylinder must be replaced when its pressure is less than 200 psig.

• To change the cylinder, see “Changing the NO therapy cylinder and purging the regulator assembly” at the end of this section.

3. Setup the ventilator. See the ventilator manual for its setup and operation.

4. Do a breathing circuit test as described in the ventilator’s operation manual.

5. Empty and clean the fluid trap. See section 10/Maintenance for the procedure.

AA.69.121

AA.69.034

6-2

Connect the INOvent delivery system to the patient circuit. Use one of the following the connection diagrams for the patient breathing circuit you are using and follow the steps shown.

02/08/00 1605-0014-000

Page 61

6/Operation

Connection diagrams in this section include the following:

ICU ventilator circuit:

Figure 6-1 System connection diagram, ICU ventilator circuit

Figure 6-2 • Adult circuit connection diagram

Figure 6-3 • Neonatal circuit connection diagram

Figure 6-4 • Pediatric circuit connection diagram

Connection to a high frequency oscillatory ventilator circuit:

Figure 6-5 System connection diagram, high frequency oscillatory

ventilator circuit

Connection to a circle anesthesia system:

Figure 6-6 System connection diagram, anesthesia system with

ventilator

Connection to a transport ventilator circuit:

Figure 6-7 System connection diagram for a transport ventilator

circuit

6-3

1605-0014-000 02/08/00

Connection to bagging systems:

Figure 6-8 • System connection diagram for a hyper-inflation

bag

Figure 6-9 • System connection diagram for a self-filling

resuscitator bag

Figure 6-10 • System connection diagram for a spontaneous

breathing circuit

6-3

Page 62

6-4

INOvent delivery system

Connection to an ICU

ventilator circuit

WARNING

CAUTION

The INOvent delivery system subtracts gas from the breathing circuit via

Note the airﬂow direction arrow on the Injector Module: ﬂow out of the

the gas sampling system; this can effect the sensitivity of a ﬂow triggered synchronized breath mode of some ventilators. The trigger sensitivity of the ventilator should be checked after connecting the INOvent delivery system to the breathing circuit

The humidiﬁer chamber volume should not be more than 480 mL to help prevent elevated NO

ventilator must be through the Injector Module in the direction of the arrow on the module.

values.

The Injector Module should only be used in the dry part of the breathing circuit to make sure ﬂow measurement is correct.

To condition ventilator ﬂow and make sure ﬂow measurements are accurate, connect the Injector Module to the humidiﬁer chamber; then, connect to the ventilator inspiratory port using breathing circuit tubing. This can also be done by placing a breathing circuit ﬁlter between the Injector Module and the ventilator.

To avoid medications interfering with the gas monitoring system, administer surfactants or other medications only on the patient side of the sample tee.

Procedure:

• When connecting breathing tubing, make sure it is long enough for any required equipment movement.

• Make sure that the system is not wheeled over tubing connected to a patient or to the equipment.

Refer to the connection diagrams in ﬁgures 6-1 through 6-4 for the following steps.

6-4

1. Connect a breathing hose from the ventilator inspiratory port to the

Injector Module

2. Connect a breathing hose or adapter from the output end of the

Injector Module to the humidifier inlet port.

3. Connect a breathing hose from the humidifier outlet port to a

sample tee.

input end using the appropriate adapters.

02/08/00 1605-0014-000

Page 63

6/Operation

54321

15 14 13 12 11 10 9

Note: The above connection diagram is also printed on the left side of the INOvent delivery system.

AA.69.017

AA.69.266

6-5

a. Injector Module b. Input end c. Output end

1. Patient wye

2. Ventilator

3. Ventilator Expiratory port

4. Ventilator Inspiratory port

5. Patient Gas sample line input connection

6. INOvent delivery system

7. NO/N

Injector Tube front panel connection

8. Injector Module Electrical Cable front panel connection

9. Injector Module Electrical Cable connection

10.Injector Module NO/N

Injector Tube connection

11.Humidifier inlet

12.Humidifier

13.Humidifier outlet

14.Patient Gas sample line connection

15.Sample Tee

Figure 6-1 •

System connection diagram, ICU ventilator

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6-5

Page 64

INOvent delivery system

4. Connect a breathing hose from the sample tee to the patient wye.

Important This breathing hose between the sample tee and the

patient wye should be between 6 and 12 inches (150 to 300 mm) long: greater than 6 inches to minimize the sampling of mixed inspired/expired concentrations, less than 12 inches to help ensure correct patient NO

measurement.

6-6

5. Connect the gas sample line from the “Sample Inlet” port on the

front of the fluid trap to the sample tee. Make sure the sample port at the T-piece is pointing upward to help avoid fluid accumulation in the sample line.

6. Connect a breathing hose from the ventilator expiratory port to the

expiratory limb of the patient wye.

7. The trigger sensitivity of the ventilator should be checked after

connecting the INOvent delivery system to the breathing circuit.

8. Proceed to “Operation” - “Setting the delivered NO concentration.”

AA.69.281

6-6

1. To INOvent delivery system

Figure 6-2 •

Adult circuit connection diagram

02/08/00 1605-0014-000

Page 65

6/Operation

AA.69.280

6-7

1. To INOvent delivery system

Figure 6-3 •

Neonatal circuit connection diagram

AA.69.282

1605-0014-000 02/08/00

1. To INOvent delivery system

Figure 6-4 •

Pediatric circuit connection diagram

6-7

Page 66

6-8

INOvent delivery system

Connection to a

high frequency

oscillatory

ventilator circuit

WARNING

CAUTION

Omission of the one-way valve may result in high NO delivery.

Note the airflow direction arrow on the one-way valve. The flow out of the Injector Module must be through the one-way valve in the direction of the arrow on the valve.

Note the airflow direction arrow on the Injector Module; the flow

out of the ventilator must be through the Injector Module in the direction of the arrow on the module.

The Injector Module should only be used in the dry part of the breathing circuit to make sure flow measurement is correct.

To avoid medications interfering with the gas monitoring system, administer surfactants or other medications only on the patient side of the sample tee.

• When connecting breathing tubing, make sure it is long enough for any required equipment movement.

• Make sure that the system is not wheeled over tubing connected to a patient or to the equipment.

Procedure:

Refer to the connection diagram in ﬁgure 6-5 for the following steps.

1. Connect tubing from the ventilator outlet to the INOvent delivery

system Injector Module input end using the appropriate adapters

2. Connect the output end of the Injector Module to the input end of a

one-way valve.

Important: Note the airflow direction arrow on the one-way

valve. The flow out of the Injector Module must be through the one-way valve in the direction of the arrow on the valve.

6-8

3. Connect the output end of the one-way valve to the humidifier inlet

port.

4. Connect tubing from the humidifier outlet port to the bias flow tube

on the high frequency oscillating ventilator.

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Page 67

6/Operation

5. Connect the gas sample line from the “Sample Inlet” port on the front of the INOvent delivery system fluid trap to a sampling tee on the Flexible Breathing Circuit of the high frequency oscillating ventilator.

1234

Tubing

Sensor Medics 3100A Ventilator

6-9

5 6

One way

Tubing

valve

Humidifier

1. High Frequency Oscillatory Ventilator

2. Ventilator outlet

3. Injector Module

4. INOvent delivery system

5. NO/N

Injector Tube connection

6. Injector Module Electrical Cable connection

7. One-way valve

8. Humidiﬁer inlet

9. Patient gas sample line connection

10. Humidiﬁer outlet

11. Bias Flow Tube

AA.69.126

AA.69.266

a. Injector Module b. Input end c. Output end

Figure 6-5 •

System connection diagram, high frequency oscillatory

ventilator

1605-0014-000 02/08/00

6-9

Page 68

6-10

INOvent delivery system

Notes:

6-10

02/08/00 1605-0014-000

Page 69

Connection to a circle

anesthesia system

WARNING

Avoid recirculation of gases. Undesired recirculation of gases will occur

if fresh gas ﬂows are less than the patient minute volume and may result in:

Use only Sodasorb in combination with Isoflurane or Desflurane. Other

anesthetic agents and CO reactive by-products.

6/Operation

• Higher NO absorbent to remove NO

• Higher NO concentrations than those set due to NO recirculated through the absorber.

• Reduction in O gas for nitric oxide and will be present in the re-circulated gases.

levels due to the limited ability of the carbon dioxide

concentration because nitrogen is the balance

absorbents have not been evaluated for

6-11

CAUTION

Note the airﬂow direction arrow on the Injector Module: the ﬂow out of

the absorber must be through the Injector Module in the direction of the arrow on the module.

O will also affect the Set NO versus the measured NO value. For a 50%

O, 50% O

7% indicated less than the same Set NO value at 100% O

composition, the measured NO value will be approximately

. For example,

at a Set NO value of 20 ppm, measured NO will be approximately 18 ppm.

Similarly, the effect of 2%v/v Isoﬂuorane will result in a high measured NO value of approximately 3% indicated for the same Set NO value at 100% O

Sudden changes in anesthetic agent concentration may cause brief transient changes in the measured NO and NO

values.

Procedure:

• When connecting breathing tubing, make sure it is long enough for any required equipment movement.

• Make sure that the system is not wheeled over tubing connected to a patient or to the equipment.

1605-0014-000 02/08/00

6-11

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INOvent delivery system

Refer to the System connection diagram in ﬁgure 6-6 for the following steps.

6-12

1. Connect the Injector Module’s

connects to the inspiratory limb of the breathing circuit.

input end to the absorber port which

Note: For OR ventilator systems with inspiratory flow measurement at the inspiratory port of the absorber, place the Injector Module upstream of the inspiratory flow sensor.

2. Connect an inspiratory breathing hose from the output end of the

Injector Module to a sample tee.

3. Connect an inspiratory breathing hose from the output end of the

Injector Module to a sample tee.

4. Connect an inspiratory limb breathing hose from the sample tee to

the patient wye:

Important This breathing hose between the sample

tee and the patient Y should be between 6 and 12 inches (150 to 300 mm) long: greater than 6 inches to minimize the sampling of mixed inspired/expired concentrations and less than 12 inches to help ensure correct patient NO

measurement.

6-12

5. Connect the gas sample line from the “Sample Inlet” port on the front

of the fluid trap to the sample tee. Make sure the sample port at the T-piece is pointing upward to help avoid fluid accumulation in the sample line.

6. Connect a breathing hose from the patient wye the absorber port

which connects to the expiratory limb of the breathing circuit.

Note: With a circle anesthesia breathing circuit, the INOvent delivery system will perform as specified in the technical specifications with fresh gas flow rates equal to or more than the patient minute ventilation.

7. Proceed to “Operation” - “Setting the delivered NO concentration.”

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Page 71

6/Operation

12 34 567

6-13

11a

11b121314

a. Injector Module b. Input end c. Output end

1 Patient wye 2 Patient Gas sample line 3 Patient Gas sample line connection (“Sample Inlet” port) 4 INOvent delivery system 5 Bellows assembly 6 Ventilator drive gas 7 Ventilator (rear view) 8 Absorber 9 Absorber expiratory port 10 Absorber Inspiratory port 11 Injector Module

a. Injector Module input end

b. Injector Module output end 12 Hose 13 22M / 15F x 22M / 15F Adapter 14 Sample Tee

AA.69.191

AA.69.266

Figure 6-6 •

System connection diagram, anesthesia system with

ventilator

1605-0014-000 02/08/00

6-13

Page 72

INOvent delivery system

Connection to a

transport ventilator

circuit

WARNING If the INOvent delivery system is to be mounted in a transportation

vehicle, it must be equipped with four (4) vibration isolation devices positioned near the feet of the device. See Appendix A for validated vibration isolators.

6-14

Connection to a BIO-MED MVP-10 or an Infrasonics Infant Star 100 ventilator is shown in ﬁgure 6-7.

When operating on the battery, keeping the display brightness and the audio alarm loudness to the minimum needed will help prolong battery charge life.

Display brightness and alarm loudness can be changed if desired by pushing the Setup key to display the Setup menu.

Note: The display brightness automatically dims to the lowest setting (1) when running on battery.

If a humidiﬁer is not being used in the breathing circuit, a “Dry Sample Gas” alarm may occur. This alarm occurs if the sample gas has less than 15% relative humidity.

The design of the gas sampling system allows its use without humidiﬁcation under certain conditions.

• When the ambient humidity is greater than approximately 45% RH, the sample gas is humidified as it flows through the INOvent delivery system and probably will not display the alarm message.

• Short term use of the INOvent delivery system with the “Dry Sample Gas” alarm present should not affect the O sensors.

, NO and NO2

6-14

Long-term use with the alarm present can reduce the life of all the sensors and may result in slightly lower NO readings.

After connection as shown in the ﬁgure for the conﬁguration you are using, proceed to “Setting the delivered NO concentration.”

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Page 73

6/Operation

6-15

AA.69.167

AA.69.266

910

a. Injector Module b. Input end c. Output end

1 Patient wye 2 Expiratory Breathing Circuit Hose 3 Patient Gas sample line 4 Ventilator Expiratory Valve 5 Ventilator 6 INOvent delivery system 7 Ventilator Inspiratory port 8 22M / 15F x 22M / 15F Adapter 9 Injector Module Electrical Cable 10 NO/N

Injector Tube

11 Injector Module 12 Inspiratory Breathing Circuit Hose 13 Sample Tee

Figure 6-7 • System connection diagram for a transport ventilator circuit

1605-0014-000 02/08/00 6-15

Page 74

INOvent delivery system

Connection to

bagging systems

circuit

The INOvent delivery system can be used with self-inﬂating and hyper-inﬂation manual resuscitator bagging systems and with spontaneous breathing circuits.

6-16

wwwwWARNING The hyperinﬂation bag will, under some conditions, contain NO2 in

excess of 1 ppm. Use of large tidal volume breaths may expose the patients to the NO

present in the bag, for part of the breath. In general,

if the inspiratory ﬂow rate induced by the manual ventilation does not exceed the fresh gas ﬂow rate, the patient should not be exposed to the concentrations of NO

Adult and infant hyperinﬂation bags generate more NO

present in the hyperinﬂation bag.

when used at

lower minute ventilation. If use of the bag is interrupted (for example to adjust the tracheal tube), before resuming ventilation of the patient the user should squeeze the bag several time to empty residual gas from the bag.

Because of the potential for inhalation of excessive concentrations of

, and the difﬁculty in monitoring the peak inhaled NO2

concentrations, ventilation with a hyperinﬂation bag or self-inﬂating bag is intended only for short term use.

The Datex-Ohmeda monitors within the INOvent will not detect generation of NO devices, and the alarms for excessive NO

within the hyperinﬂation bag or self-inﬂating bag

cannot warn of NO2 produced

within the manual bag system.

To minimize the delivered concentration of NO

, the following steps

should be taken for use with the manual resuscitator bags:

a. Concentrations of greater than 20 ppm NO should not be

used due to excessive NO

generation.

b. Use the smallest bag adequate to deliver the desired tidal

volume.

c. Inspiratory tubing lengths greater than 72 inches should

not be used.

d. Use the highest fresh gas flow rated (up to 15 L/min) that is

practical.

e. Use the lowest practical inspired oxygen concentration.

f. After starting fresh gas flow, squeeze the bag several times

to empty residual gas in the bag prior to using the system to ventilate a patient.

Testing has only been conducted using specific hyperinflation and self-

inflating bag systems. See Appendix A for validated manual resuscitator breathing systems.

6-16 02/08/00 1605-0014-000

Page 75

Procedure:

6/Operation

wwwwCAUTION New O

tubing must be used each time for optimal ﬁt on 4.5 mm adapter.

If a humidiﬁer is not being used in the breathing circuit, a “Dry Sample Gas” alarm may occur.

This alarm occurs if the sample gas has less than 15% relative humidity. The design of the gas sampling system allows its use without humidiﬁcation under certain conditions.

• When the ambient humidity is greater than approximately 45% RH, the sample gas is humidified as it flows through the INOvent delivery system and probably will not display the alarm message.

• Short term use of the INOvent delivery system with the “Dry Sample Gas” alarm present should not affect the O

, NO and NO2

sensors. Long-term use with the alarm present can reduce the life of all the sensors and may result in slightly lower NO readings.

Note the values shown in Tables 6-1 and 6-2.

Bagging system connections are shown in:

6-17

• Figure 6-8 for a hyper-inflation bag,

• Figure 6-9 for a self-filling resuscitator bag,

• Figure 6-10 for a spontaneous breathing circuit.

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INOvent delivery system

6-18

wwwwWARNING The values of NO

tracheal tube under the speciﬁc test conditions. Use of lower fresh gas ﬂows than shown in the tabulated information will increase the

concentration of NO

Table 6-1 • Neonatal

Hyperinﬂation Manual

Resuscitator Breathing Circuit

Table

Set

NO(ppm)

10 0.4 0.2 150 20 8

10 0.1 0.1 150 40 15

10 0.1 0.1 50 80 8

10 0.1 0.1 50 40 15

20 0.4 0.2 150 20 8

20 0.1 0.4 150 40 15

tracheal tube (ppm)

in the following table are the values expected in the

in the inhaled gas.

The following table shows the maximum measured NO

values in the

inspiratory limb and at the rear of the breathing bag after ﬁve minutes of bagging. Carrier gas = 100% oxygen, I:E = 1:2.

measured at

NO2 measured

in bag (ppm)

Vt(mL)

Rate

(bpm)

Flow Rate

(L/min)

20 0.1 0.4 50 20 8

20 0.1 0.3 50 40 15

WARNING Concentrations greater than 20 ppm NO should not be used

because of excessive NO

generation.

40 0.3 1.3 50 20 8

40 0.2 1.4 50 40 15

40 0.6 0.3 150 20 8

40 0.2 1.5 150 40 15

80 0.8 5.2 50 20 8

80 0.8 4.1 50 40 15

80 1.0 3.6 150 20 8

80 0.8 5.4 150 40 15

6-18 02/08/00 1605-0014-000

Page 77

6/Operation

wwwwWARNING The values of NO

tracheal tube under the speciﬁc test conditions. Use of lower fresh gas ﬂows than shown in the tabulated information will increase the

concentration of NO

Table 6-2 • Adult

Hyperinﬂation Manual

Resuscitator Breathing Circuit

Table

Set

NO(ppm)

10 0.2 0.2 700 20 5

10 0.0 0.1 500 40 15

10 0.0 0.1 300 20 5

10 0.0 0.1 200 40 15

20 0.5 0.6 700 20 5

20 0.1 0.4 500 40 15

tracheal tube (ppm)

in the following table are the values expected in the

in the inhaled gas.

The following table shows the maximum measured NO

values in the

inspiratory limb and at the rear of the breathing bag after ﬁve minutes of bagging. Carrier gas = 100% oxygen, I:E = 1:2.

measured at

NO2 measured

in bag (ppm)

Vt(mL)

Rate

(bpm)

Flow Rate

(L/min)

6-19

20 0.1 0.4 300 20 5

20 0.1 0.4 200 40 15

WARNING Concentrations greater than 20 ppm NO should not be used

because of excessive NO

generation.

40 0.3 2.1 300 20 5

40 0.4 2.3 200 30 15

40 0.9 1.9 700 20 5

40 0.4 2.4 500 30 15

80 1.2 9.0 300 20 5

80 1.4 9.0 200 30 15

80 2.8 8.8 700 20 5

80 1.5 9.1 500 30 15

1605-0014-000 02/08/00 6-19

Page 78

6-20

INOvent delivery system

123 456

78910111213

Flowmeter

AA.69.166

2 Injector Module Electrical Cable 3 NO/N2 Injector Tube 4O2 Tubing 5O2 Tubing Sample Tee 6 Patient Gas sample line 7 Hyper-Inflation Bag 8 Pressure Gauge 9 15M x 4.5 mm Adapter for the output end of the Injector Module 10 Injector Module 11 22M / 15F x 22M / 15F Adapter for the input end of the Injector

Module

12 15M x 4.5 mm Adapter

Tubing

13 O

Figure 6-8 • System connection diagram for a hyper-inflation bag

6-20 02/08/00 1605-0014-000

Page 79

6/Operation

6-21

AA.69.165

1O2 Flowmeter 2O2 Tubing 3 15M x 4.5 mm Adapter 4 22M / 15F x 22M / 15F Adapter for the input end of the Injector

Module 5 Injector Module 6 15M x 4.5 mm Adapter for the output end of the Injector Module 7O

Tubing

8O2 Tubing Sample Tee 9 Patient Gas sample line 10 Resuscitator bag with O2 reservoir 11 NO/N2 Injector Tube 12 Injector Module Electrical Cable

Figure 6-9 • System connection diagram for a self-filling resuscitator

bag

1605-0014-000 02/08/00 6-21

Page 80

6-22

INOvent delivery system

13141516

AA.69.164

1234 5 6 7 8 91011 12

Tubing

2 15M x 4.5 mm Adapter 3 22M / 15F x 22M / 15F Adapter 4 Breathing Circuit Tee 5 Breathing Circuit Bag 6 Injector Module 7 Breathing Circuit Hose 8 Sample Tee 9 22M / 15F x 22M / 15F Adapter 10 One-way valve 11 Sealed Face Mask 12 One-way valve 13 Patient Gas Sample Line 14 NO/N

Injector Tube

15 Injector Module Electrical Cable 16 O2 Flowmeter

AA.69.164

Figure 6-10 • System connection diagram for a spontaneous breathing

circuit

6-22 02/08/00 1605-0014-000

Page 81

Operation

6/Operation

Setting or changing

the delivered NO

concentration

After connecting the INOvent delivery system to the patient circuit, turn the INOvent delivery system ON.

• Turning the system on delivers nitric oxide concentration when there is flow in the patient circuit.

• Figure 6-11 shows a normal state display with the Set NO bargraph at off after the startup tests are completed.

6-23

510k_3.tif510k_4.tif

Figure 6-11 • Set NO display - Set NO is 0.0 ppm (OFF)

To set or change the NO concentration delivered:

1. Push the Set NO button.

• The bargraph border now flashes

• The bargraph top now becomes a moveable double line indicating the current concentration setting.

2. Turn the control wheel clockwise to increase the NO concentration or counterclockwise to decrease the concentration. Figure 6-12 shows the concentration line set at 20 ppm.

Figure 6-12 • Set NO display - NO setpoint is a double line

1605-0014-000 02/08/00 6-23

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6-24

INOvent delivery system

3. Push either the Set NO button or the control wheel to confirm the newly-entered concentration.

• If you don’t push the button or the wheel within five seconds, a reminder message, shown in figure 6-13, appears to prompt you to do so. A highlight box around the display flashes.

• If you don’t respond to the message within 15 seconds, the system defaults to its previous NO setting.

510k_5.tif510k_6.tif

Figure 6-13 • Set NO display - confirm new NO setpoint reminder

message

• Figure 6-14 shows the NO concentration set to 20 ppm after the Set NO button or the control wheel is pressed. The system is now set to deliver the new concentration.

Figure 6-14 • Set NO display - normal state, NO bargraph showing 20

ppm setting

4. After the monitored values have stabilized, you can set or change the user-adjustable alarms. (See section 7/Alarms for changing the alarm settings.)

Note: NO delivery dilutes the therapy gas O

concentration up to

10% depending upon the Set NO concentration.

The system is now ready for use. The new NO concentration is delivered when there is ﬂow in the patient circuit.

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Page 83

During operation

Pausing NO flow

wwwwWARNING Do not pause ﬂow more than two times consecutively to avoid elevated

values when NO delivery is resumed.

The Low NO alarm is disabled while NO ﬂow is paused.

Nitric oxide ﬂow can be paused for two-minute periods.

To pause nitric oxide ﬂow during operation:

1. Press the Pause Flow button to display the Pause Flow confirmation message box shown in figure 6-15.

6/Operation

6-25

Figure 6-15 • Pause Flow confirmation message box

2. Then:

• Press the Pause Flow button a second time to pause the nitric oxide flow. The FLOW PAUSED message box appears with a two-minute countdown timer as shown in figure 6-16.

or:

• Press the Control Wheel to remove the Pause Flow confirmation message box. The Pause Flow confirmation message box disappears after 15 seconds if no action is taken.

1605-0014-000 02/08/00 6-25

510k_18.tif

Page 84

INOvent delivery system

510k_19.tif

6-26

Changing the NO

therapy cylinder and

purging the regulator

assembly

wwwwWARNING You MUST purge the regulator assembly IMMEDIATELY BEFORE using a

new NO cylinder to make sure the patient continues to receive the correct NO concentration and does not receive greater than 3.0 ppm of NO

Important Replace an NO therapy gas cylinder when its pressure is less than 200 psig.

Figure 6-16 • FLOW PAUSED message box

Once nitric oxide ﬂow is paused, it will resume:

• if the Resume Flow button is pressed or

• after two minutes have passed.

When the nitric oxide ﬂow is resumed, the FLOW PAUSED message is removed.

The regulator assembly must be purged immediately before using a new NO therapy gas cylinder. A small purge manifold allows you to purge the regulator assembly. The manifold is located either between the regulators on the transport cart or attached to the wall mount regulator inlet ﬁtting.

To purge the regulator assembly immediately before using a new NO therapy gas cylinder do the following.

1. Determine which regulator assembly is not being used and requires purging. The cylinder valve should be closed on this regulator assembly that is not being used.

6-26 02/08/00 1605-0014-000

Page 85

6/Operation

2. On this regulator assembly that requires purging, disconnect the low pressure hose quick-connect fitting from the NO/N rear of the INOvent delivery system (shown in figure 6-17.)

Figure 6-17 • Low pressure hose quick-connect fittings

3. Open the cylinder valve on the new NO therapy gas cylinder.

4. Close the cylinder valve on the new NO therapy gas cylinder.

input on the

AA.69.147

6-27

5. Check for leaks at the cylinder valve outlet connection of the new therapy cylinder using soapy water (see 13/Appendix B.)

6. Insert the low pressure hose quick-connect fitting into the purge manifold. See figure 6-18.

1 Purge manifold 2 Low Pressure Hose Quick-Connect Fitting

Figure 6-18 • Inserting the low pressure hose quick-connect fitting into

the purge manifold

7. Firmly push and hold the quick-connect fitting in place while the pressure drops to zero on the regulator gauge.

8. After the pressure drops to zero (approximately 15 seconds), reconnect the low pressure hose quick-connect fitting to the NO/N2 input on the rear of the INOvent delivery system.

AA.69.152

1605-0014-000 02/08/00 6-27

Page 86

6-28

INOvent delivery system

To use the new cylinder:

1. Open the cylinder valve on the new cylinder.

2. Close the cylinder valve on the empty cylinder and label appropriately.

3. Replace the empty NO therapy gas cylinder (see 13/Appendix B.) Leave the replacement cylinder valve turned off until needed. The purge procedure will be performed on this cylinder immediately before its use.

Electronic delivery

shutdown

If the electronic NO delivery fails:

• A loud buzzer operates and

• The system stops NO delivery to the patient and

• Displays a message similar to the one in figure 6-19.

Figure 6-19 • System shutdown display

1. Record the service information as requested on the display.

2. Turn the system to STANDBY.

3. Use the Manual NO delivery system which can still be used. If you need to know how to use the manual system, see “Manual NO Delivery System operation” in section 8/Manual NO delivery system.”

6-28 02/08/00 1605-0014-000

SD1

Page 87

Monitoring the environment

You can use the system monitor to measure the environmental levels of NO and NO2. You will need a Luer ﬁtting cap for the patient line sample tee.

1. Disconnect the sample line connector from the sample tee.

Figure 6-20 • Sample line connector at the sample tee

6/Operation

6-29

AA.69.017

2. Cap the Luer fitting on the sample tee to prevent gas loss from the patient circuit.

wwwwWARNING After removing the sample line connector, cap the Luer fitting on the

sample tee to prevent gas loss from the patient circuit.

3. With the sample system turned on, sample the room air with the sample line and read the NO and NO press the Alarm Silence button to turn it off.

4. After environmental monitoring, remove the Luer fitting cap on the sample tee and reconnect the sample line.

readings. If an alarm occurs,

1605-0014-000 02/08/00 6-29

Page 88

6-30

INOvent delivery system

Notes:

6-30 02/08/00 1605-0014-000

Page 89

7/Alarms

In this section 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 ranges. . . . . . . . . . . . . . . . . . . . . . . . 7-5

Alarm adjustment procedure . . . . . . . . . . . . . . . . . . . . . 7-5

Clearing resolved alarm messages . . . . . . . . . . . . . . . . 7-7

Alarm message table . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

1605-0014-000 02/08/00 7-1

Page 90

INOvent delivery system

General alarm information

Note: Refer to the your ventilator manual for information on the Apnea, High Pressure and High Pressure Relief alarms.

An Alarm message table is provided at the end of this section.

7-2

High, medium and

low priority alarms

All alarms have tones and visible messages. You’ll see and hear an alarm when:

• the measured value of a gas exceeds the high or low limits shown in the measured value display area,

• a device alarm condition occurs, such as an expended monitor cell.

A secondary alarm circuit activates when the main alarm circuit fails, providing a continuous, non-silenceable buzzing tone. In this case the system must be turned off.

Alarms have priorities of high, medium and low. Higher priority alarm messages are displayed in the upper left alarm message area ﬁrst.

See ﬁgure 7-1. The most recent high priority alarm message (for example “High NO”) is shown in the top left part of the alarm message area. High priority alarm messages are shown on a

light background.

7-2

Figure 7-1 •

The most recent medium priority alarm message (for example “High O

” in figure 7-2) appears in normal video in the top right or the top left

part of the alarm message area.

High priority alarm message shown in most recent alarm

location (upper left)

02/08/00 1605-0014-000

510k_20

Page 91

7/Alarms

510k_21‘510K_22

7-3

Figure 7-2 •

Medium priority alarm message shown in most recent

alarm location (upper left)

Alarm silencing

The most recent low priority alarm message (for example “Sample Line/Filter Block” in figure 7-3) appears in right part of the alarm message area.

Figure 7-3 •

Push the Alarm Silence button to silence high and medium priority alarms for 120 seconds. Most low priority alarms are permanently silenced.

Low priority alarm message shown in low priority alarm

location

normal video in the bottom

1605-0014-000 02/08/00

Alarm messages, however, remain visible during the alarm silence period as long as the alarm cause is active.

Note: Tone loudness is set through the Setup button menu.

The following table provides alarm tone information.

7-3

Page 92

INOvent delivery system

7-4

Alarm

Priority

High:

Medium:

Low:

Figure 7-4 shows that a High NO alarm message has been silenced. Note the alarm silenced symbol in the top left location indicating a silenced alarm. An alarm silenced countdown timer has counted down from 120 seconds and now indicates 114 seconds remaining of the silence period.

2 1

Tone

Frequency

400 Hz 5-pulse group Repeats after 10

400 Hz 3-pulse group Repeats after 25

400 Hz 1 pulse Repeats after 40

Tone

Description

Comment

seconds if not silenced.

510k_23

Changing the alarm

settings

7-4

1. Countdown timer

2. Alarm silenced symbol

3. High nitric oxide alarm message

Figure 7-4 •

Each alarm setting is displayed below its respective measured gas value. See figure 7-5.

1. Measured gas value

2. Low alarm limit

3. High alarm limit

Figure 7-5 •

Silenced alarm and countdown timer example (upper left

of the display)

Alarm setting displays

02/08/00 1605-0014-000

510k_23

Page 93

7/Alarms

When an alarm occurs for a measured gas concentration, the measured value and the alarm limit setting are displayed on a light background. (See figure 7-6.)

Alarm adjustment

ranges

Alarms Adjustment Step value Default Detection range Priority

High NO (ppm) 1 to 100 * 1 90 * NO > high limit High

Low NO (ppm)

(Can be OFF)

High NO

High O

(Can be OFF)

(ppm) 0 to 5 0.1 3 NO

(% v/v)

1. Measured gas alarming

2. Alarm limit exceeded

Figure 7-6 •

OFF, 0.1 to

Alarm active display

0.1 Off NO < low limit High

9.9*

10 to 100* 1.0

21 to 100 1 100 % O

> high limit High

> high limit Medium

510k_21

7-5

Low O

Alarm adjustment

procedure

1605-0014-000 02/08/00

(% v/v) 18 to 100 1 % 21 % O

* Values shown are for maximum Set NO range of 80 ppm. For other maximum Set NO ranges, the high adjustment range and the default value is 1.5 X maximum NO Set.

A user-adjustable low limit alarm cannot be set above the high limit setting.

1. With the monitor ON and after the monitored values have stabilized, push the Alarms button to show the Alarms menu.

< low limit High

7-5

Page 94

INOvent delivery system

This menu lets you:

7-6

• Set a high limit for measured values of the three gases (O

, NO

and NO.)

• Set a low limit for the measured values of NO and O

• Exit to the normal display.

2. Turn the control wheel to highlight the alarm setpoint to be changed. In figure 7-7, the Low NO alarm setting is highlighted.

Figure 7-7 •

Alarms menu - low NO alarm setting highlighted

3. Push the control wheel to select the highlighted alarm setpoint for change; in figure 7-8 the Low NO setpoint is shown in a selection box.

510k_7.tif510k_8.tif

7-6

Figure 7-8 •

Alarms menu - low NO alarm setting selected for

adjustment

4. Turn the control wheel until the value you wanted is displayed in the selection box.

5. Push the control wheel to confirm your selection. The alarm limit is displayed below its respective measured gas value when the normal display is shown. See figure 7-9.

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Page 95

7/Alarms

510K_22

Clearing

resolved alarm

messages

Figure 7-9 •

6. If you are finished with the Alarms menu, turn the control wheel to select Exit to Normal Display. To adjust another value, continue using the above procedure. Push the control wheel to exit when you are finished.

An “Alarm History” indication in the top right location of the display indicates there are resolved alarms that can be reviewed and cleared.

A resolved alarm is an alarm that occurred but is no longer true: that is, the alarm message came and went. A history of up to the last ten resolved alarm messages is stored for analysis or troubleshooting.

Push the Alarm History button to see the Alarm History menu. The messages are displayed in chronological order, starting with the most recent resolved alarm.

New nitric alarm limit set

7-7

1605-0014-000 02/08/00

Note: The alarm history list is cleared if the INOvent delivery system is turned OFF and then ON.

To clear alarm messages on the resolved alarm history list:

1. Push the Alarm History button to see the Alarm History menu.

• Figure 7-10 shows page 1 of the menu when there are more than five alarm messages.

• Figure 7-11 shows page 2 of the menu used when there are more than five alarm messages.

7-7

Page 96

INOvent delivery system

510k_24.tif

7-8

Figure 7-10 •

Resolved Alarm History menu - six or more resolved

alarms, page 1

Figure 7-11 •

Resolved Alarm History menu - 6 or more resolved

alarms, page 2

2. Turn the control wheel to highlight the message or action wanted.

3. Push the control wheel to complete the action you want or go to the next page. Figure 7-12 shows the menu with all alarm messages removed.

510k_25.tif510k_26.tif

7-8

4. When finished, turn the control wheel to “Exit to Normal Display.” Push the wheel to exit.

Figure 7-12 •

Resolved Alarm History menu - resolved alarms cleared

A list of alarm messages starts on the next page.

02/08/00 1605-0014-000

Page 97

Alarm message table

WARNING

The INOvent delivery system should not be connected to the patient

during troubleshooting or service activities.

When an alarm occurs, check the patient condition and then check the equipment.

Use the table below for information on conditions.The last column references numbers in the Troubleshooting Guide table of section 9/ Troubleshooting.

7/Alarms

7-9

See Troubleshooting

Alarm Priority Conditions

Battery

Inoperable

Low Displayed when running on mains power and

battery not functioning.

Low Battery High Displayed when running on battery and charge is

Guide number:

low.

Low Battery

Charge

Running on

Low Displayed only when running on mains power and

battery charge is low.

Low Displayed only when running on battery. 16

Battery

Set NO Error Low System detects a Set NO communication error. 7

Water Bottle Full Low System detects full water bottle. 18

Sample Line/

Filter Block

Low System failed to clear blockage after 3 purge

routines.

Dry Sample Gas Low Sample gas < 15% relative humidity. 11

Wet Sample

Low Sample gas > 95% relative humidity. 35

Gas

Calibration Due Low Loss of calibration data. 25

Failed NO Cell Low System detects absence or failure of an NO cell. 26

Failed NO

Failed O

Cell Low System detects absence or failure of an NO

Cell Low System detects absence or failure of an O

cell. 27

cell. 28

Weak NO Cell Low Weak NO cell detected during calibration. 29

Weak NO

Weak O

Cell Low Weak NO

Cell Low Weak O

cell detected during calibration. 30

cell detected during calibration. 31

High NO High Measured NO value > User set limit; default: 1.5 x

Bargraphmax*, but not greater than 90 ppm.

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7-9

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INOvent delivery system

7-10

High NO Flow High During calibration, NO ﬂow changed and NO

concentration may exceed 100 ppm or O

dilution

> 20%.

High NO

High Measured NO

value > User set limit; default: 3.0

ppm.

High O

Medium Measured O

value > User set limit; default: 100

Low NO High Measured NO value < User set limit; default: Off. 1, 3

Low NO/N

High NO therapy gas supply pressure < 32 psig. 4

Pressure

Low O

Decreased NO

Flow

Increased NO

Flow

Measured NO <

Set NO

Measured NO >

Set NO

Injector Module

High Measured O

value < User set limit; default: 21 %. 21

Low NO ﬂow < 60% of NO ﬂow when calibration was

initiated.

Low NO ﬂow > 160% of NO ﬂow when calibration was

initiated.

Low NOmeas < 50% of NOset and NOmeas < NOset -

NOoffset.**

Low NOmeas > 150% of NOset and NOmeas > NOset

+ NOoffset.**

High System cannot detect a working Injector Module. 34

Fail

1, 5

1, 6

Delivery Failure High Calculated NO ﬂow is outside acceptable range or

leak rate was unacceptable at Power-ON.

Monitoring

Failure

Low Monitor fails to communicate correctly or reports a

fault.

System Failure Shutdown NOmeas > 2 x Bargraphmax or 100 ppm or other

system failure. *

Service

Low System detects a condition which needs service. 33

Advisory

* Bargraphmax = Maximum value settable on the Set NO

Bargraph.

** NOoffset = 5 ppm when Set NO range = 0 - 20

7 ppm when Set NO range = 0 - 40 10 ppm when Set NO range = 0 - 80.

- End of Alarm message table -

7-10

02/08/00 1605-0014-000

Page 99

8/Manual NO delivery system

In this section Manual NO delivery system description . . . . . . . . . . . . . . . . . 8-2

Manual NO delivery system connections . . . . . . . . . . . . . . . . 8-3

Manual NO delivery system operation . . . . . . . . . . . . . . . . . . 8-4

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INOvent delivery system

Manual NO delivery system description

The Manual NO delivery system permits continued NO delivery if the ventilator or the main INOvent delivery system fails. The manual system is completely pneumatic and is not linked to the primary delivery system.

The Manual NO delivery system is used with a pressure compensated (PC) O (user supplied) to deliver a 20 ppm concentration of NO to the patient with an O2 flowrate of 15 L/min and an 800 ppm NO cylinder.

flowmeter (user supplied) and a manual resuscitator bag

The pressure compensated O function and is used to set the O

flowmeter provides the ON/OFF

flow at 15 L/min. A shutoff valve in

the delivery system prevents NO flow if there is insufficient O2 flow.

When the manual NO delivery system is operating correctly, the float in the NO Flow Indicator Window will be in the position shown in figure 8-1.

NO/O

1. Float

2. NO Flow Indicator Window

69.023

Figure 8-1 • Manual NO delivery system: NO Flow Indicator Window

and Float

8-2 02/08/00 605-0014-000