INOblender Operation and Maintenance Manual

INOblender Operation and Maintenance Manual
Operation and Maintenance Manual
(English)
Part No. 20003 Rev - 01
Part No. 20181 Rev-04
2014-02
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 prior to use following the
Pre-Use Checkout procedure described in section
3. A defective Product should not be used. Parts
that are broken, missing, visibly worn, distorted or
contaminated should be replaced immediately.
Should such repair or replacement become
necessary, the manufacturer recommends that a
telephone request for service advice be made to
the local distributor. This Product or any of its parts
should not be repaired other than in accordance with
written instructions provided by the manufacturer or
local distributor. The Product must not be altered.
The user of this Product shall have the sole
responsibility for any malfunction which results from
BL 20051234
10026
10004
10021
10070
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 indicate the year of manufacture and a
sequential unit number for identification.
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.
INOblender (DISS, 800 ppm, English)
INOblender (DISS, 800 ppm, English)
INOblender (NIST, 400 ppm, English)
INOblender (NIST, 800 ppm, English)
©2014 Ikaria, Inc.
INOMAX®, INOmax DSIR®, and INOblender® are registered trademarks of INO Therapeutics LLC and their respective owners. INO Therapeutics LLC
is a wholly-owned subsidiary of Ikaria, Inc.
Part No. 20181 Rev-04
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Contents
1. General Information.............................................................................................................. 3
Introduction........................................................................................................................ 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....................................................................................................... 18.
Parts and Accessories..................................................................................................... 19
6.
Specifications..................................................................................................................... 21
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General
Information
1/ General Information
Part No. 20003 Rev - 01
Part No. 20181 Rev-04
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General
Information
1/ General Information
Part No. 20181 Rev-04
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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 repeatedly
during use to avoid NO2 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.
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.
• 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.
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.
• 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 NO2. Persons using
the INOblender who may be particularly
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 that this is vented at the resuscitator
bag. Ambient concentrations of NO or
NO2 are expected to be less than 0.2 ppm
when using the INOblender, see Section 1
Environmental Effects.
• 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 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.
3
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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.
Symbols used in this manual or on the system
Symbols replace words on the equipment and/or in this manual. These symbols include:
Attention, consult accompanying
documents!
Pneumatic Outlet
Rx ONLY
Authorized Representative in the
European Community
Prescription use only
Pressure
Catalog Number
Date of Manufacture
Product packaging is able to be
recycled
Fragile, handle with care
Protect from heat and radioactive sources
SN
Keep Dry
Storage Temperature Limitation
Manufacturer
Storage Humidity Limitation
NO or O2 Gas Inlet
This product is in compliance with the
European Council Directive 93/42/EEC
and its amendments concerning medical
devices
NO Gas Outlet
Pneumatic Inlet
Part No. 20181 Rev-04
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Serial Number
4
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
5
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Environmental Effects
The National Institute for Occupational Safety and
Health (NIOSH) has recommended exposure limits
as follows (ref 1).
Both methods show that the exposure levels are
significantly less than the levels recommended
by NIOSH.
NO
time-weighted (8 hours) average concentration limit of 25 ppm
NO2
ceiling limit of 1 ppm.
If the location for using NO has uncertain ventilation,
then the location should be evaluated for NO and
NO2 build up prior to use.
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.
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
Ref. 2
Room ventilation 2,700 L/min
at 6 room
changes / hr
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
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 used. The maximum NO and NO2
concentrations measured over a one-hour period
were 0.12 ppm of NO and 0.03 ppm of NO2.
Part No. 20181 Rev-04
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6
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.
Setup
2/ Setup
Part No. 20003 Rev - 01
Part No. 20181 Rev-04
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Setup
2/ Setup
Part No. 20181 Rev-04
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Setup
Check the INOMAX gas cylinder for the correct
product identity labels, cylinder concentration
(800 or 400 ppm) and expiration date. Ensure the
INOMAX gas cylinder has > 14 bar (200 psig).
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 16).
•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 17).
1
3
1. Connect a high-pressure regulator to an INOMAX cylinder and hand tighten the fitting to the INOMAX cylinder.
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: 3.5 bar (50 psig) nominal
To oxygen source
1
2
1. Make sure the NO dose setting dial is turned to zero.
2. Attach a manual resuscitation bag to the INOblender outlet fitting.
The INOblender is now set up. Proceed to Section 3/Pre-use Checkout.
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Pre-Use
Checkout
3/ Pre-Use Checkout
Part No. 20003 Rev - 01
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Pre-Use
Checkout
3/ Pre-Use Checkout
Part No. 20181 Rev-04
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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
High-Pressure Leak Test
1.Make sure NO dose setting dial is turned to zero
and flow meter is OFF.
2
3
2.Open and then close the cylinder valve.
3.Pressure gauge should indicate > 14 bar
(200 psig).
4.Monitor pressure gauge for 30 seconds for
any signs of pressure decrease. If no pressure
decrease is observed, high-pressure leak test
successful, proceed to Delivery Confirmation
and Purge.
5.If observed pressure decrease continues, see
Section 5/ Maintenance; Cylinder Leak Check.
6.If leak cannot be traced, replace the INOblender.
Delivery Confirmation and Purge
2
1. Set the INOblender to 40 ppm when using an 800 ppm cylinder (20 ppm when using a 400 ppm cylinder).
1
2. Set the oxygen flow on the INOblender flow meter to 10 L/min to begin purge.
3.Ensure the pressure gauge decreases approximately 14 bar (200 psig) in 10 seconds
(+ 2 sec.).
3
4. Continue purging until pressure gauge
reads zero.
Note:
4
If the pressure does not decrease, then
the INOblender is not delivering NO and
the INOblender should be replaced.
The INOblender is now ready for use. Proceed to Section 4/Operation.
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Operation
4/ Operation
Part No. 20003 Rev - 01
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Operation
4/ Operation
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Operation
WARNINGS:
• The purge procedure 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 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 bag purge procedure performed before continuing. • The INOblender should be upright when setting the oxygen flowrate for accurate setting.
• Do not use pneumatically powered nebulizers with the INOblender. This will result in significant
over delivery of INOMAX (nitric oxide) for inhalation in excess of 80 ppm (40 ppm with a 400 ppm
cylinder).
- The INOblender outlet pressure has been validated for use up to 400 millibar (5.8 psig)
pressure. The amount of back-pressure generated by pneumatic nebulizers is significantly
greater [1.4 - 2.0 bar (20-30 psig)] and will result in over delivery of INOMAX in excess of
80 ppm with an 800 ppm cylinder (40 ppm with a 400 ppm cylinder). The user adjusted dose
setting on the INOblender will not correlate with, or have an effect on, the actual delivered
dose.
- In addition, the INOblender flowmeter is not back-pressure compensated and will display a
lower than actual flow rate when pressure is applied to the outlet.
Cautions: • When not in use, the oxygen flowmeter and the INOMAX cylinder valve should be turned off.
• When the INOblender is used with an oxygen/air blender:
- The specification for INOMAX delivery when using the INOblender with 100% oxygen is +/- 20% of
setting or 2 ppm (whichever is greater). The use of 100% oxygen at 3.4 bar (50 psig) is the labeled
specification for the INOblender.
- A user may determine that some clinical conditions may necessitate the use of an oxygen/air
blender with the INOblender to achieve FiO2 levels less than 100%.
- Using oxygen/air mixtures (21% to 95% v/v) will reduce the delivered NO concentration by up to
10% of setting or 1 ppm (whichever is greater) compared to using 100% oxygen alone, resulting in
a cumulative error up to +/- 30% of setting or 3 ppm (which ever is greater).
• Refer to the manufacturer’s procedures when using the manual resuscitator bag.
• When finished, turn the NO cylinder valve OFF and allow the oxygen to flow until the NO pressure gauge
reads zero, then turn the oxygen flow OFF.
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12
Prior to operation, complete the Pre-Use Checkout in Section 3.
The purge procedure contained in the Pre-use Checkout helps ensure any NO2 is purged from the pressure
regulator, INOblender and hoses before the manual resuscitator bag is connected to the patient.
Note: Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DSIR prior
to removing from the cylinder valve.
1
2
1. Open the INOMAX cylinder valve.
2. Check for supply pressure of > 14 bar
(200 psig).
Adjust Settings
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).
3
2. Turn the O2 flowmeter to the desired flow rate
(5 to 14 L/min).
1
3. Squeeze the manual resuscitator 3-4 times
to purge the NO2 from the system.
2
The INOblender is now ready for patient use.
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14
Maintenance
5/ Maintenance
Part No. 20003 Rev - 01
Part No. 20181 Rev-04
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Maintenance
5/ Maintenance
Part No. 20181 Rev-04
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Maintenance
Cautions:
• When cleaning, do not submerge in liquid.
• Do not autoclave.
Note: The INOblender does not contain any user repairable parts.
Cleaning Procedure
Caution: • Apply cleaning agent to a cloth before application; do not spray cleaning agent directly on the device.
It is important to prevent pooling and direct contact with open connections which can cause damage
over time.
- Clean the outer surface of the INOblender with a soft cloth dampened in a mild soap and water solution
(Example: Palmolive Ultra antibacterial, 4 drops per 50 mL of warm water), isopropyl alcohol (70%), or
with one of the following cleaning agents while following the manufacturer’s recommendations.
Cleaning Agent
Active Ingredients
Precise Hospital Foam Cleaner
Disinfectant by Caltech Industries
o-Phenylphenol < 0.37%
Other ingredients 99.63%
Pure Green 24 by Pure Green, LLC
SDC – silver ions 0.003%
Citric acid 4.84%
Other ingredients 95.157%
PDI Super Sani Cloth by PDI
n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.25%
n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium
chlorides 0.25%
Isopropyl alcohol 55%
Inert ingredients 44.50%
Sani Cloth HB by PDI
n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium
chlorides 0.07%
n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.07%
Inert ingredients 99.86%
Asepti-HB by Ecolab Inc.
n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium
chlorides 0.07%
n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.07%
Inert ingredients 99.86%
Cavicide and CaviWipes by Metrex
Diisobutylphenooxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%
Isopropyl alcohol 17.2%
Inert ingredients 82.52%
Bioquell Hydrogen Peroxide Sterilant
Bioquell Hydrogen Peroxide Sterilant and hydrogen peroxide vapor generators are regulated by the US
Environmental Protection Agency (EPA) as pesticide chemicals in accordance with Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Use of these products in cleaning/disinfection processes have not
been validated with the INOblender. Do not use these products to decontaminate the INOblender or any
ancillary products used with the INOblender.
15
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Yearly Calibration
The INOblender calibration should be checked every 12 months using the NO monitor of the primary NO
delivery system. The test points should include all the control settings at oxygen gas flows of 5 and 14 L/min.
If the INOblender is outside of the accuracy specification, it should not be used.
Contact Customer Support at the number on the back cover of this manual for repair.
Replacing the CGA 626 tip on the INOMAX regulator
Note: •Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DSIR prior
to removing from the cylinder valve.
•Check the INOblender and connection hoses for signs of wear and damage.
•For the CGA-type regulator connector, ensure the white plastic tip is not chipped or cracked. Remove
and replace as necessary. (see Figure 5-1).
1.Disconnect the regulator from the INOMAX
gas cylinder.
2.Remove the old CGA 626 tip (for ISO see Figure 5-2) by pulling on the tip (a) and turning
it counterclockwise (b) (see Figure 5-1).
b
3.Ensure the threads are clean on the
regulator tip (if required, use a lint free cloth).
4.Install the new tip:
a
Flex the four prongs by squeezing two prongs
at a time using only your fingers. This will help
start the new tip into the threads. Turn the tip
clockwise when threading the tip. When the
tip is fully inserted, it should turn freely.
Figure 5-1
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16
Replacing the O-ring on the ISO 5145 INOMAX
regulator fitting
Note: •Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DSIR prior
to removing from the cylinder valve.
•Check the INOblender and connection hoses for signs of wear and damage.
•For the ISO-type regulator connector, check that the O-ring is present and is not damaged
(see Figure 5-2).
Note: Depressurize the INOMAX regulator by
using the purge port on the back of the
INOmax DSIR prior to removing from the
cylinder valve.
1. Disconnect the regulator from the INOMAX
therapy gas cylinder.
2. Remove the old ISO O-ring by rolling it off its
groove (see Figure 5-2).
3. Clean the connector tip (if required, use a lint
free cloth).
O-ring
4. Roll the new O-ring into its groove. When
correctly installed, it should not be removable
by turning it.
Gland
Figure 5-2
Caution:
Do not use hard objects to remove the O-ring as they may damage the metal gland and cause a leak.
17
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Cylinder Leak Check
If a leak is suspected during the high-pressure leak test (see Section 3/Pre-Use Checkout; High Pressure
Leak Test), the following steps can be taken to check for leaks (see Figure 5-3 for possible cylinder gas leak
locations) in the INOMAX regulator or INOMAX cylinder.
Note:
Refer to hospital policies and procedures for dealing with leaking gas cylinders. Additional information regarding environmental effects can be found in
the section 1/General Information.
5
4
6
1. Ensure that INOMAX regulator is connected to
cylinder valve outlet (hand-tighten only), that the
cylinder valve is open, and that the cylinder has
more than 14 bar (200 psig).
2. Apply soapy water to points 1, 2, 3, 5 and 6 (see
Figure 5-3); if bubbles form, there is a leak.
3. If there are no bubbles, leak may be inside
INOblender or INOmax DSIR and cannot be
repaired. Replace INOblender or INOmax DSIR
and contact Customer Support.
Recommended actions should a leak be detected:
2
3
1
1.
2.
3.
4.
5.
6.
Cylinder Valve Regulator Connection
INOMAX Regulator Hand Wheel Connection
Regulator End Cap Connection
Tamper Evident Tape
Valve Nut
Safety Pressure Release Device
Figure 5-3
Part No. 20181 Rev-04
2014-02
1. A leak detected at points 1 and 2 (see Figure
5-3) may be corrected by 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 bubbles form, there is a leak.
d. Remove INOMAX regulator and check white
plastic tip on INOMAX regulator for chips or
cracks. Replace if necessary (see replacing
the tip on the INOMAX regulator, page 16).
For the ISO type regulator connector, check
that the O-ring is present and is not damaged.
Replace if necessary (see replacing the
O-ring on the INOMAX regulator, page 17).
Repeat step b (note: If leak remains, replace
INOMAX regulator).
2. If a leak is detected between the regulator body
and regulator end cap (see point 3), replace
INOMAX regulator and contact Customer Support.
3. A leak detected at cylinder valve nut connection
(see point 5) may not be repaired.
Replace INOMAX cylinder and contact Customer Support.
4. A leak detected at safety pressure release device
(see point 6) may not be repaired. Replace
INOMAX cylinder and contact Customer Support.
18
Parts and Accessories
WARNING:
Use only parts/accessories designated for use with this system.
Parts/Accessories
Part Number
Clamp Assembly
10008
Hose Assembly, Oxygen Green, DISS to DISS, 15 Feet
80344
Hose Assembly, Oxygen White, DISS to DISS, 15 Feet
80345
Hose Assembly, Oxygen White, DISS to SIS, 15 Feet
80353
Hose Assembly, Oxygen White, NIST to NIST, 15 Feet
80481
INOMAX Regulator, CGA 626
10006
INOMAX Regulator, ISO 5145
10020
INOMAX Regulator Extension Hose
10014
Operation and Maintenance Manual
20181
O-ring, ISO 5145 INOMAX Regulator
80470
Tip, CGA 626 INOMAX Regulator
1605-3149-000
Transport Mounting Bracket Assembly/Spacer
50041
Operation and Maintenance Manual
Part Number
English
20181
Czech
20308
Danish
20309
Dutch
20310
Finnish
20311
French-EU
20312
French-Canadian
20331
German
20313
Hungarian
20314
Italian
20315
Japanese
20076
Korean
20316
Norwegian
20317
Polish
20318
Portuguese
20319
Spanish-EU
20301
Spanish-LATAM
20305
Swedish
20320
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6/ Product Specifications
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Specifications
INOblender
Ü NO Set Range
5 to 80 ppm (800 ppm cylinder)
2.5 to 40 ppm (400 ppm cylinder)
Setting accuracy
+/- 20 % indicated or 2 ppm, whichever is greater
Gas flow range
5 to 14 L/min of O2
O2 inlet connection
DISS (male), 3.4 bar (50 psig, nominal)
NO/N2 inlet pressure
1.7 to 2.4 bar (25 to 35 psig)
NO inlet Quick disconnect with shut-off (Female)
NO/O2 outlet Barb fitting for oxygen supply tubing
Max. Dimensions
200 mm (W) X 120 mm (H) X 110 mm (D) DISS (clamp included)
200 mm (W) X 120 mm (H) X 131 mm (D) NIST (clamp included)
Max. weight
1.7 kg (clamp included)
Operating 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% to 98% non condensing
Storage Barometric Pressure
57 to 110 kPa
INOMAX Pressure Regulator
Cylinder Valve Connector
CGA 626 or ISO 5145 valve
Inlet Pressure
14 to 155 bar (200 to 2,248 psig)
NO Outlet Pressure
1.7 to 2.4 bar (25 to 35 psig)
Manual Resuscitators
The INOblender is compatible with most types of manual resuscitation bags when used within the specifications of this
device. The INOblender has been validated against the following manual resuscitation bags.*
* Airlife Adult Manual Resuscitator with reservoir tubing
* Allegiance ½ L Pediatric Manual Resuscitator with reservoir tubing
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Manufacturer
North America
INO Therapeutics LLC d/b/a Ikaria, Inc.
Perryville III Corporate Park
53 Frontage Road, Third Floor
Hampton, NJ 08827-9001, USA
1-877-566-9466
www.ikaria.com
Europe
European Authorized Representative
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Part No. 20181 Rev-04
2014-02
Europe
Australia
Australia Representative
Ikaria Australia Pty Ltd.
+61 3 9882 4855
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