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Part No. 20732  Rev-02

2014-02

3

Cautions and Warnings

WARNINGS:

• The purge procedure must be followed 

to help ensure NO

2

 is purged from the 

pressure regulator, INOblender and hoses 

before the manual resuscitator bag or nasal 

cannula is connected to the patient. The 

manual bag should be squeezed repeatedly 

during use to avoid NO

2

 building up in the 

bag. If the bag is not squeezed repeatedly 

while delivering INOMAX the bag should 

be removed from the patient and the purge 

procedure performed before continuing. 

•  The INOblender should only be used 

in accordance with the indications, 

usage, contraindications, warnings and 

precautions described in the INOMAX drug 

package insert and labeling. Refer to this 

material prior to use.

•  Persons using this device should be trained 

on and experienced in the use of this 

device to assure effective administration of 

INOMAX and to avoid injury to the patient 

or others resulting from inhalation of 

excess INOMAX, nitrogen dioxide or other 

reaction products.

•  The National Institute for Occupational 

Safety and Health (NIOSH) in the U.S. has 

a recommended time-weighted (8 hours) 

average concentration of 25 ppm for NO 

and a limit of 1 ppm for NO

2

. Persons using 

the INOblender who may be particularly 

sensitive to NO or NO

2

, 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 that this is vented at the resuscitator 

bag. Ambient concentrations of NO or 

NO

2

 are expected to be less than 0.2 ppm 

when using the INOblender, see Section 1 

Environmental Effects.

Cautions:

•  Outside the U.S. and Canada, check local 

laws for any restrictions that may apply.

 

U.S. federal law and Canadian law restrict this 

device to sale by or on the order of a licensed 

medical practitioner.

•  Proper use of this product depends on careful 

reading and understanding of labeling and 

instructions.

•  To help ensure proper operation of this 

product, complete the pre-use checkout prior 

to each use.

•  When not in use, the O

2

 flow meter and the 

INOMAX cylinder valve should be turned off.

•  When cleaning, do not submerge in liquid.
•  Do not autoclave.
•  Refer to the manufacturer’s procedures for 

using the resuscitation bag.

 WARNING:

Warnings tell you about dangerous conditions 

that can cause injury to the operator or the 

patient if you do not obey all of the instructions 

in this manual. 

 Caution:

Cautions tell you about how to properly use 

the equipment and conditions that could cause 

damage to the equipment. 
Read and obey all warnings and cautions.

Note:

Notes provide clarification or supplemental information.

Blue arrow denotes required user action.

Содержание INOblender 10026

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

Страница 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...

Страница 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...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 14: ...Part No 20732 Rev 02 2014 02 8 Intentionally left blank...

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

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

Страница 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...

Страница 18: ...Part No 20732 Rev 02 2014 02 10 Intentionally left blank...

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

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

Страница 21: ...Part No 20732 Rev 02 2014 02 11 Intentionally left blank...

Страница 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...

Страница 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...

Страница 24: ...Part No 20732 Rev 02 2014 02 14 Intentionally left blank...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 32: ...Part No 20732 Rev 02 2014 02 20 Intentionally left blank...

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

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

Страница 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...

Страница 36: ...Part No 20732 Rev 02 2014 02 22 Intentionally left blank...

Страница 37: ...17 Part No 20732 Rev 02 2014 02 23 Intentionally left blank...

Страница 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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