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Part No. 20732  Rev-02

2014-02

4

Pneumatic Outlet

Rx ONLY

Prescription use only

Pressure

Product packaging is able to be

 

recycled

Protect from heat and radioactive sources

SN

Serial Number

Storage Temperature Limitation

Storage Humidity Limitation

This product is in compliance with the 

European Council Directive 93/42/EEC 

and its amendments concerning medical 

devices

Attention, consult accompanying 

documents!

Authorized Representative in the 

European Community

Catalog Number

Date of Manufacture

Fragile, handle with care

Keep Dry

Manufacturer

NO or O

2

 Gas Inlet

NO Gas Outlet

Pneumatic Inlet

Introduction

The INOblender allows users to select a concentration of INOMAX, (nitric oxide in a balance of nitrogen), to 

be mixed into a user set flow of oxygen which is delivered to a patient. The intended use for the INOblender 

is as a back up to a primary INOMAX delivery system; or for short term attended use when a primary delivery 

device cannot practicably be used. This intended use includes applications within a medical facility and 

transport outside of a medical facility. The INOblender is not intended for use as a primary INOMAX delivery 

system for long term use.

Definitions and abbreviations

N

2

Nitrogen

NO

INOMAX (nitric oxide) for inhalation

NO

2

Nitrogen dioxide

NO/N

2

Nitric oxide (NO) and nitrogen (N

2

) gas mixture

O

2

Oxygen

ppm

Parts Per Million

Set NO

The dose of INOMAX set by the user

v/v

Volume to volume

Note: This manual shows the Set NO displays associated with the 0-80 ppm range.

Symbols used in this manual or on the system

Symbols replace words on the equipment and/or in this manual. These symbols include:

Summary of Contents for INOblender 10026

Page 1: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 Operation and Maintenance Manual English...

Page 2: ...e faulty maintenance improper repair damage or alteration by anyone other than Mallinckrodt Representatives Outside the U S A and Canada check local laws for any restrictions that may apply Caution U...

Page 3: ...roduction 4 Definitions and Abbreviations 4 Theory of Operation 5 Environmental Effects 6 2 Setup 7 3 Pre Use Checkout 9 4 Operation 12 5 Maintenance 15 Replacing Regulator Tips 16 Cylinder Leak Check...

Page 4: ...Part No 20732 Rev 02 2014 02 2 Intentionally left blank...

Page 5: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 1 General Information General Information...

Page 6: ...Part No 20732 Rev 02 2014 02 1 General Information General Information...

Page 7: ...y sensitive to NO or NO2 or who may be exposed to these agents for prolonged periods as a result of the use of this device should be aware that the INOblender does not scavenge the exhaust drug and th...

Page 8: ...to be mixed into a user set flow of oxygen which is delivered to a patient The intended use for the INOblender is as a back up to a primary INOMAX delivery system or for short term attended use when a...

Page 9: ...INOblender is also connected to a 2 bar 30 psig INOMAX 800 ppm or 400 ppm supply The INOMAX flow is controlled by a balance regulator in proportion to the oxygen pressure caused by the fixed restrict...

Page 10: ...easurements as performed by Hess et al The NO and NO2 concentrations were measured using a chemiluminescence analyzer when 100 ppm of NO at 8 L min was delivered into a room with no scavenging being u...

Page 11: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 2 Setup Setup...

Page 12: ...Part No 20732 Rev 02 2014 02 2 Setup Setup...

Page 13: ...pply to the O2 inlet fitting see part list for correct oxygen hose Note 3 5 bar 50 psig nominal 1 Make sure the NO dose setting dial is turned to zero 2 Attach a manual resuscitation bag to the INOble...

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Page 15: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 3 Pre Use Checkout Pre Use Checkout...

Page 16: ...Part No 20732 Rev 02 2014 02 3 Pre Use Checkout Pre Use Checkout...

Page 17: ...nnot be traced replace the INOblender Delivery Confirmation and Purge 1 Set the INOblender to 40 ppm when using an 800 ppm cylinder 20 ppm when using a 400 ppm cylinder 2 Set the oxygen flow on the IN...

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Page 19: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 4 Operation Operation...

Page 20: ...Part No 20732 Rev 02 2014 02 4 Operation Operation...

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Page 22: ...must be followed to help ensure NO2 is purged from the system before the manual resuscitator bag is connected to the patient The manual bag should be squeezed repeatedly during use to avoid NO2 from...

Page 23: ...1 Turn the INOblender setting dial to the desired concentration 5 to 80 ppm for an 800 ppm cylinder and 2 5 to 40 ppm for a 400 ppm cylinder 2 Turn the O2 flowmeter to the desired flow rate 5 to 14 L...

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Page 25: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 5 Maintenance Maintenance...

Page 26: ...Part No 20732 Rev 02 2014 02 5 Maintenance Maintenance...

Page 27: ...by Metrex Diisobutylphenooxyethoxyethyl dimethyl benzyl ammonium chloride 0 28 Isopropyl alcohol 17 2 Inert ingredients 82 52 Caution Apply cleaning agent to a cloth before application do not spray c...

Page 28: ...SO see Figure 5 2 by pulling on the tip a and turning it counterclockwise b see Figure 5 1 3 Ensure the threads are clean on the regulator tip if required use a lint free cloth 4 Install the new tip F...

Page 29: ...the O ring as they may damage the metal gland and cause a leak O ring Gland Replacing the O ring on the ISO 5145 INOMAX regulator fitting Note Depressurize the INOMAX regulator by using the purge port...

Page 30: ...tightening the INOMAX regulator hand wheel a If cylinder valve is open close cylinder valve and tighten INOMAX regulator hand wheel b Open cylinder valve and reapply soapy water to points 1 and 2 c If...

Page 31: ...1 INOMAX Regulator CGA 626 10006 INOMAX Regulator ISO 5145 10020 INOMAX Regulator Extension Hose 10014 Operation and Maintenance Manual 20732 O ring ISO 5145 INOMAX Regulator 80470 Tip CGA 626 INOMAX...

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Page 33: ...Part No 20003 Rev 01 Part No 20732 Rev 02 2014 02 6 Product Specifications...

Page 34: ...Part No 20732 Rev 02 2014 02 6 Product Specifications...

Page 35: ...ting and Storage Conditions Operating Temperature 10 to 40 C Operating Humidity 15 to 95 non condensing Operating Barometric Pressure 57 to 110 kPa Storage Temperature 40 to 70 C Storage Humidity 15 t...

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Page 38: ...565 Europe European Authorized Representative MDSS GmbH Schiffgraben 41 30175 Hannover Germany Part No 20732 Rev 02 2014 02 Manufacturer North America Mallinckrodt Manufacturing LLC 6603 Femrite Driv...

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