INOblender Operation and Maintenance Manual Rev 01

User Responsibility This Product will perform in conformity with the description 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 such repair or replacement become necessary, INO Therapeutics LLC d/b/a Ikaria® recommends that a telephone request for service advice be made to the nearest Field Technical Service Support Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ikaria. The Product must not be altered without the prior written approval of Ikaria 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 Ikaria. Outside the U. S. A. and Canada, check local laws for any restrictions that may apply. Caution: U. S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local regulations. Ikaria products have unit serial numbers with coded logic which indicates the year of manufacture and a sequential unit number for identification.

BL 20051234

The first two digits indicate the product, the next four numeric digits indicate the year of manufacture, and the next four digits are the sequential unit number produced that year.

10026

INOblender® part number

©2010 Ikaria, Inc. INOMAX®, INOmax® DSIR, INOblender®, INOcal® and INOvent® are registered trademarks of INO Therapeutics, LLC. 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 and foreign equivalents.

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Contents 1.

General Information ... 1 Introduction ... 2 Definitions and Abbreviations ... 2 Theory of Operation ... 3 Environmental Effects ... 4

2.

Setup ... 5

3.

Pre-Use Checkout ... 7

4.

Operation ... 9

5.

Maintenance ... 11 Replacing Regulator Tips... 12 Parts and Accessories ... 14

6.

Specifications... 15 Warranty ... 17

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Cautions and Warnings WARNING:

WARNINGS:

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.

• The purge procedure must be followed to help ensure NO2 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 continuously during use to avoid NO2 building up in the bag. If the bag is not squeezed continuously while delivering INOMAX® the bag should be removed from the patient and the purge procedure performed before continuing.

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.

Cautions:

• 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.

• Outside the U.S. A 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.

• Persons using this device should be trained 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.

• Proper use of this product depends on careful reading and understanding of labeling and instructions.

• The National Institute for Occupational Safety and Health (NIOSH) has a recommended time-weighted (8 hours) average concentration of 25 ppm for INOMAX and a limit of 1 ppm for NO2. Persons using the INOblender who may be particularly sensitive to INOMAX 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 that this is vented at the resuscitator bag. Ambient concentrations of INOMAX or NO2 are expected to be less than 0.2 ppm when using the INOblender, see Section 1 Environment Effects.

• To help ensure proper operation of this product, complete the pre-use checkout prior to each use. • When not in use, the O2 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. When finished, turn the INOMAX cylinder off and continue to flow O2 until the NO pressure gauge reads zero, then turn the O2 flow off and the NO dial to zero ppm.

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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 N2

Nitrogen

NO

INOMAX (nitric oxide) for inhalation

NO2

Nitrogen dioxide

NO/N2

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

O2

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.

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Theory of Operation 1. The INOblender® connects to a 3-5 Bar (45-75 psig) oxygen supply. The oxygen flow is then controlled by an integrated oxygen flow meter (2-14 lpm). There is a fixed restrictor in the oxygen flow path which creates a pressure proportional to the oxygen flow rate. 2. The 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 restrictor and the INOblender setting. • The balance regulator maintains a constant INOMAX dose for varying oxygen flow rates. 3. The flows of O2 and INOMAX are mixed prior to exiting the INOblender outlet.

INOblender Schematic Diagram INOMAX Regulator

INOMAX Cylinder

Oxygen Source Balance Regulator

Dose Knob

Fixed Laminar Restrictor

INOMAX and O2 Outlet

INOMAX Oxygen Oxygen/INOMAX

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Environmental Effects The National Institute for Occupational Safety and Health (NIOSH) have recommended exposure limits as follows (ref 1). NO

time-weighted (8 hours) average concentration limit of 25 ppm

NO2

ceiling limit of 1 ppm.

with no scavenging being used. The maximum INOMAX and NO2 concentrations measured over a one hour period were 0.12 ppm of INOMAX and 0.03 ppm of NO2. Both methods show that the exposure levels are significantly less than the levels recommended by NIOSH. If the location for using INOMAX has uncertain ventilation then the location should be evaluated for INOMAX and NO2 build up prior to use.

The environmental build up of nitric oxide in a well ventilated ICU room can be evaluated using the following calculation. Room size

10 ft square (approx. 3 meters)

Room volume of air

27,000 L

Room ventilation at 6 room changes / hr

2,700 L/min

Ref. 1 Centers for Disease Control, Atlanta, GA 30333 USA. NIOSH Recommendations for Occupational Safety and Health Standards 1988. August 26, 1988 / vol. 37 /No. 9.

Ref. 2 Hess et al, Use of Inhaled Nitric Oxide in patients with Acute Respiratory Distress Syndrome, Respiratory Care, 1996, vol. 41, No 5, pg. 424-446.

NO flow into room 14 L/min at 80 ppm Average room concentration of NO

80 x 14 / 2,700 = 0.4 ppm of NO

This theoretic calculation can be supplemented by measurements as performed by Hess et al. The INOMAX® and NO2 concentrations were measured using a chemiluminescence analyzer when 100 ppm of INOMAX at 8 L/min was delivered into a room

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Setup

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Setup

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Setup Check the INOMAX® cylinder for the correct identity label and the correct concentration (800 ppm or 400 ppm).

Note: • For the CGA type INOMAX regulator connector, ensure the white plastic tip is not chipped or cracked. Remove and replace as necessary. (see Replacing the tip on the INOMAX regulator, Page 12). • For the ISO type regulator connector, check that the O-ring is present and is not damaged (see Replacing the tip on the INOMAX regulator, Page 13).

1. Connect the INOMAX regulator to the cylinder.

1 3

2. Connect the INOMAX regulator hose to the INOblender® inlet hose using the quick connect fittings.

2

3. Connect the oxygen supply to the O2 inlet fitting. (see part list for correct oxygen hose) Note: 50 psig (nominal) To oxygen source

1

1. Make sure the NO dose setting dial is turned to zero. 2. Attach a manual resuscitation bag to the INOblender outlet fitting.

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The INOblender is now set up. Proceed to section 3 Pre-use Checkout.

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Pre-Use Checkout

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Pre-use Checkout Caution: To help ensure proper operation, complete the pre-use checkout prior to each use. Set-up the INOblender® as described in section 2 Setup

Perform leak test:

1

1. Open and then close the INOMAX® cylinder valve.

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2. Pressure gauge should indicate at least 200 psig. Note:

Pressure should not decrease in a 30 second period. If pressure does decrease, check for leaks using soapy water at the blender NO inlet fitting; tighten if needed. If leak cannot be traced, replace the INOblender.

Perform delivery confirmation and purge: 2 1

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 INOblender flow meter to 10 L/min to begin purge. 3. Ensure the pressure gauge decreases approximately 200 psig in 10 seconds (+ 2 sec.).

3

Note:

If the pressure does not decrease, then the blender is not delivering NO and the blender should be replaced.

4. Continue “purging” until pressure gauge reads zero.

4

The INOblender is now ready for use. Proceed to section 4 Operation.

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