INOvent Operation and Maintenance Manual

User Responsibilty 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 Datex-Ohmeda 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 order 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. AAA A 12345 This alpha character indicates the year of product manufacture and when the serial number was assigned; “C” = 1999, “D” = 2000, “E” = 2001, etc. “I” and “O” are not used. © 2001 Datex-Ohmeda Inc No license is conveyed, either expressed or implied, with the purchase hereof under U.S. Patent 5,485,827 and U.S. Patent 5,427,729 and their foreign equivalents. U.S. Patent 5,558,083. Foreign equivalents pending.

Table of Contents

1 Introduction

Important... 1-2 Definitions and abbreviations... 1-3 Symbols used in the manual or on the system... 1-4

2 General Information

Overview... 2-2 Configuration options... 2-3 Main component views... 2-4 Display and user controls... 2-7 Theory of operation... 2-10 INO Flow from the cylinder to the patient breathing circuit... 2-10 Effect of inserting the INOvent into a breathing circuit... 2-12

3 Setup

INOvent delivery system connections... 3-2 Mounting... 3-2 System connections... 3-2 Manual NO delivery system connections... 3-8 Electrical connections... 3-9 Setup menu... 3-12 Cylinder concentration... 3-12 Hourmeter display... 3-12 To set the alarm loudness... 3-12 To set the display brightness... 3-13

4 Calibration

Calibration information... 4-2 NO, NO2 And O2 Sensor low range calibration (daily, room air)... 4-2 NO, NO2 And O2 Sensor high range calibration... 4-5

5 Pre-Use Procedures

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

6 Operation

Before operation... 6-3 Connection to an ICU ventilator circuit... 6-4

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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...6-26 Pausing NO flow...6-26 Changing NO therapy cylinder and purging the regulator assembly . .6-27 Electronic delivery shutdown...6-30

7 Alarms

General alarm information...7-2 High, medium and low priority alarms...7-2 Alarm silencing...7-3 Changing the alarm settings...7-5 Alarm adjustment ranges...7-6 Alarm adjustment procedure...7-6 Viewing and clearing resolved alarm messages...7-8 Alarm message table...7-10

8 Manual NO delivery system

Manual NO delivery system description...8-2 Manual NO delivery system operation...8-3

9 Troubleshooting

Troubleshooting procedure...9-2 If the system fails to operate properly...9-2 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

ii

User maintenance schedule...10-2

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INOvent delivery system cleaning... 10-4 Injector Module sterilizing and disinfecting... 10-5 Autoclave sterilizing... 10-5 High level disinfecting... 10-5 Monthly System Checkout... 10-7 1. Initial connections leak tests... 10-7 2. Purge and system alarms tests... 10-9 3. Calibration and monitoring alarms...10-10 4. INOvent delivery system performance...10-12 5. Manual NO delivery system purge and performance...10-13 Emptying the Fluid Trap Bottle...10-15 Replacing the Fluid Trap Filter Cartridge...10-16 Replacing the NO2 Sensor...10-17 Replacing the NO Sensor...10-18 Replacing the O2 Sensor...10-20 Cleaning or replacing the Cooling Fan Filter...10-21 Fuse replacement and line voltage selection...10-22 System identification...10-22 High pressure hose connector...10-24 CGA-type connector...10-24 ISO-type connector...10-25 BS 341 14 connector...10-26

11 Parts and Accessories

Standard accessories... 11-2 Optional accessories... 11-2 Replaceable parts... 11-3 Calibration parts... 11-4

12 Appendix A - Specifications

Functional... 12-2 Ventilator compatibility... 12-2 Adult Ventilators... 12-2 Anesthesia Ventilators... 12-2 Neonatal Ventilators... 12-3

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High Frequency Oscillatory Ventilators...12-3 Transport Ventilators...12-3 Manual Resuscitator Breathing Systems...12-3 Manual NO delivery system...12-3 Injector Module...12-3 NO delivery...12-4 Maximum NO delivery...12-4 Gas monitoring...12-6 Calibration Gas cylinders...12-6 Calibration Gas regulator...12-6 NO Delivery shutdown...12-6 Physical...12-7 Dimensions...12-7 Cylinder dimensions to fit on the cart...12-7 Vibration Isolator for Transport...12-7 Environmental...12-8 Electrical...12-8 Third-Party Primary Regulators... 12-10

13 Appendix B - Cylinder Information

Warnings...13-2 Preparing the NO therapy gas cylinder for use...13-3 Replacing the NO therapy gas cylinder...13-3 NO therapy gas cylinder leak check...13-5 Cylinder information...13-6

14 Appendix C - Pre-Use Procedures Card

...14-1

15 Appendix D - Transport INOvent delivery system and Extended Battery Life Option

Description...15-2 Battery operation information...15-2 Setup...15-4 Operation...15-5 Maintenance...15-6

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Table of Contents

User maintenance schedule... 15-6 Optional regulator connection diagrams... 15-7 Replaceable parts and accessories... 15-8 Specifications... 15-9 Dimensions... 15-9 Electrical... 15-9

16 Appendix E - Optional Mounting

Cart mount... 16-2 Cylinder restraint mounting bracket... 16-4 Shelf or table mount... 16-5 Optional Cylinder Mount Regulator and Hose assembly... 16-5 Optional Low Pressure Hose assembly withQuick-Connectors... 16-5

Index

...I-1

Warranty

...W-1

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Notes:

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1 Introduction

w WARNING

If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures. Use only pharmaceutical grade NO/N2.

In this section

Important... 1-2 Definitions and abbreviations... 1-3 Symbols used in the manual or on the system... 1-4

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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 and subject to change. Read the User Responsibility statement on the inside front cover of this manual; it describes what the user must do to maintain this product.

w WARNING

The INOvent delivery system must only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the nitric oxide drug package inserts and labeling. Drug package inserts and labeling are packaged with each drug cylinder. Refer to this material prior to use. The use of devices which radiate high-intensity electrical fields may affect the operation of the delivery system. Do not drape the leads of these devices across the delivery system. Constant surveillance of all monitoring and life support equipment is mandatory whenever interfering devices are in operation on or near a patient.

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Definitions and abbreviations

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% v/v:

% volume/volume

Button:

A pushbutton control used to select a function.

Control wheel:

Rotary control used to change and confirm settings or actions.

Display:

The electronic information panel on the front of the delivery system.

HFOV:

High frequency oscillating ventilator.

Menu:

A list of available choices for an operation.

Menu area:

Area in the display where choice selections are shown.

Message area:

Area in the display where information is shown.

N2:

Nitrogen.

NO:

Nitric oxide.

NO2:

Nitrogen dioxide.

NO/N2:

Nitric oxide (NO) and nitrogen (N2) gas mixture.

Numeric area:

Area in the display where values and settings are shown.

O2:

Oxygen.

Pop-up box:

Menu or message which appears on the display.

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1-4

Resolved alarm:

An alarm whose cause has been corrected.

Set NO:

The concentration of NO delivered by the system as set by the user.

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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:

ø On (power.)

Ê This way up.

O Off.

π Dangerous voltage.

o Standby.

≈ Input.

∏ Alternating current.

Ù Output.

x Protective earth ground.

REF Stock number.

y Earth ground.

SN Serial number.

Alarm Silence.

Y Equipotential.

+ Plus, positive polarity.

- Minus, negative polarity.

N Movement in one direction.

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Sample gas outlet.

O2 Sensor connector.

NO/O2 Manual delivery system.

NO2 Sensor.

NO Sensor.

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INOvent delivery system

134°C Autoclavable.

Í Not autoclavable.

O2 Sensor.

Product “Use by” information (indicating warranty expiration date as YYYY-MM).

m Type B equipment.

Replace fuse only as marked.

µ Type BF equipment.

Indicates operating-on-battery.

w Warning and Caution symbol. XXXX

wW Attention, consult accompanying documents, IEC 601-1.

Keep dry.

1-6

European Union Representative

A system with this mark agrees with the XXXX European Council Directive (93/42/EEC) 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.

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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... 2-10 NO Flow from the cylinder to the patient breathing circuit... 2-10 Effect of inserting the INOvent into a breathing circuit... 2-12

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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 O2, NO2, and NO, and a comprehensive alarm system. • The interactive control panel and display provide a simple-to-understand 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 2 therapy with a resuscitator bag.

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2 General Information

Configuration Options The INOvent delivery system is available in two configuration options: • Shelf or table option and • Mounted on a cart which holds two NO therapy gas cylinders.

The options provide the setup which meets the needs of the work environment.

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INOvent delivery system

Main component views 1 8 7 6 5

4 1. 2. 3. 4. 5. 6. 7. 8.

3

AA.69.034

2

Display and operating panel Manual NO Delivery System Activity Indicator NO/N2 Injector Tube connector Injector Module Electrical Cable connector Fluid Trap Bottle Inspiratory Gas Sample Line connector Inspiratory Gas Sample Line Fluid Trap Filter Cartridge

Figure 2-1 • INOvent delivery system, front view

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2 General Information

2

1

3

4

5 6 7

15

8 9

14

13

12

11

10

AA.69.147

16

1. NO Sensor 2. NO2 Sensor 3. Nurse Call connector 4. Serial Port connector 5. Power Entry Module 6. Power Cord Clamp 7. Power Cord connector 8. External Ground connection point 9. ON/STANDBY switch 10. Cooling Fan and Filter 11. O2 Sensor 12. Sample gas outlet 13. Low pressure NO/N2 hose with quick connector (2) 14. Low pressure NO/N2 hose connector (2) 15. Resuscitator Bag O2 Tube connector 16. Connector to the O2 Flowmeter

Figure 2-2 • INOvent delivery system, rear view

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INOvent delivery system

1

3

2 AA.69.266

4

1. 2. 3. 4.

NO/N2 injector tube connection to the INOvent delivery system Inspiratory limb breathing circuit connection; to humidifier Inspiratory limb breathing circuit connection; from ventilator Electrical cable connection to the INOvent delivery system

Figure 2-3 • Injector Module, side view

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