AeroNOx 2.0 Operators Manual Rev A

Page 1

AeroNOx 2.0

™

Portable Nitric Oxide

Titration & Monitoring System

Operator’s Manual

Page 2

Po

ortable Nitrric Oxiide

Titratio

T

on & Monito

M

oring S

System

Operator’s M

Manual









Ph

hone: (51

12) 873-00

033

Fa

ax: (512) 873-9090

0

E-M

Mail: salles@int-b

bio.com

We

ebsite: http://www

h

w.int-bio..com



Ma

ailing add

dress:

Intternational Biome

edical

82

206 Cross

s Park Dr.

r.

Au

ustin, TX 78754

US

SA



Au

uthorized

d represen

ntative in

n Europe for Regu

ulatory Afffairs:

Em

mergo Eu

urope

Prrinsesseg

gracht 20

25

514 AP

Th

he Hague,, The Nettherlands

s

Page 3

This page intentionally left blank.

Page 5

TABLE OF CONTENTS

6.

7.

8.

9.

10.

5.2. Gas Supply .................................................................................................................... 58

5.3. Troubleshooting Guide ................................................................................................ 59

CALIBRATION .......................................................................................................................... 66

6.1. Low Range (ZERO) Calibration (Daily) ........................................................................ 66

6.2. O2 High Range Calibration (WEEKLY) ........................................................................ 67

6.3. NO High Range Calibration (WEEKLY) ....................................................................... 69

6.4. NO2 High Range Calibration (WEEKLY) ...................................................................... 71

MAINTENANCE ........................................................................................................................ 74

7.1. User Maintenance Schedule ........................................................................................ 74

7.2. Cleaning the AeroNOx 2.0 ......................................................................................... 74

7.3. Preventive Maintenance ............................................................................................... 75

7.4. Return Merchandise Authorization ............................................................................. 75

7.5. Replacing NO, NO2, and O2 Sensors ........................................................................... 76

7.6. Battery Replacement .................................................................................................... 79

7.7. Replacing the Seal on the AeroNOx 2.0 Regulators ............................................... 80

7.8. Parts and Accessories ................................................................................................. 81

7.9. Mounting Options ......................................................................................................... 81

7.10. Disposal ......................................................................................................................... 82

WARRANTY.............................................................................................................................. 83

PRODUCT SPECIFICATIONS .................................................................................................. 85

9.1. Ventilator Compatibility................................................................................................ 85

9.2. Measurement Range and Accuracy ............................................................................ 85

9.3. Backup Delivery Regulator .......................................................................................... 85

9.4. INOstat Bagger .............................................................................................................. 85

9.5. AeroNOx 2.0 Delivery Regulator ............................................................................... 86

9.6. AeroNOx 2.0 Physical Specifications ....................................................................... 86

9.7. AeroNOx 2.0 Environmental Specifications ............................................................ 86

9.8. AeroNOx 2.0 Electrical Specifications ..................................................................... 87

9.9. Sensor Specifications .................................................................................................. 87

9.10. EMC Compliance........................................................................................................... 87

9.11. Essential Performance ................................................................................................. 90

APPENDIX ................................................................................................................................ 91

10.1. NO2 Sensor Datasheet .................................................................................................. 91

10.2. NO Sensor Datasheet ................................................................................................... 93

10.3. Oxygen Sensor Datasheet ........................................................................................... 95

10.4. Competency Based Performance Check-off Tool ...................................................... 96

Part No. 715-0086, Rev. A

-2-

Page 6

1.

GENERAL INFORMATION

1.1.

Introduction

This manual describes the theory of operation, frequently used features, safety

considerations, specifications, and maintenance for the AeroNOx 2.0 nitric oxide (NO)

delivery system. Each AeroNOx 2.0 provides the basic equipment required for NO

delivery and accessories are available to accommodate specific installations.

The AeroNOx 2.0 system includes an integrated nitric oxide gas delivery system and

nitric oxide (NO), nitrogen dioxide (NO2), and oxygen (O2) analyzer. The AeroNOx 2.0

is a stand-alone, lightweight, portable unit designed to continuously monitor NO, NO2,

and O2 concentrations in a breathing circuit.

The AeroNOx 2.0 system is specifically designed for the delivery and monitoring of

gaseous nitric oxide (NO) in parts per million (ppm) concentrations.

The AeroNOx 2.0 is designed for use within a hospital or during patient transfer via

rescue vehicle, fixed wing aircraft, or helicopter.

1.2.

Intended Use

The AeroNOx 2.0 is intended to provide a constant controlled concentration of nitric

oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the

inspiratory limb of a mechanical ventilator that operates using a continuous constant flow

of fresh gas into the inspiratory limb of the ventilator. The AeroNOx 2.0 is also

intended to be used with a flow inflating manual ventilator (an AeroNOx 2.0 accessory),

by introducing controlled flows of nitric oxide into the fresh gas flow to the manual

ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen

concentrations in the breathing gas.

The AeroNOx 2.0 is intended to be used within a hospital or during air or ground

transport outside the hospital.

1.3.

1.4.

Medical Indication

Nitric oxide therapy is intended to treat late pre-term neonates ( 34 weeks gestation,

< 14 days of age) diagnosed with Persistent Pulmonary Hypertension of the Newborn

(PPHN) described as:

a.

A failure to achieve transition to air breathing due to a lung parenchymal disease

such as meconium aspiration syndrome, pneumonia, or infant respiratory distress

b.

Idiopathic PPHN in which the lung parenchyma is normal but the pulmonary

vasculature has been remodeled

c.

Documentation of pulmonary hypertension by a pediatric cardiologist

Contraindication

The only contraindication for inhaled nitric oxide therapy is neonates dependent on rightto-left shunting of blood. Always refer to the inhaled Nitric Oxide Gas prescribing

information sheet.

Part No. 715-0086, Rev. A

-3-

Page 7

1.5.

Safety Sum

mmary

The AeroN

NOx 2.0 is

s intended for

f use onlyy by qualifie

ed clinicians, under the

e direction of

a qualified physician. All person

nnel operatiing the systtem should

d be thoroug

ghly familiar

ating instruc

ctions, warn

nings, and ccautions co

ontained in this manua

al. The

with opera

AeroNOx 2.0

2

should

d be verifie

ed according

g to the pro

ocedures in

n this manua

al before

putting into

o operation. If the unitt fails any p

portion of th

he checkout procedure

e, it must be

e

removed frrom service

e and repaired.

1.6.

Classificattion

According to the stan

ndard EN60

0601-1 of th

he Internatio

onal Electro

otechnical C

Commission,

Medical ellectrical equ

uipment, Pa

art 1: Gene

eral requirem

ments for safety, the A

AeroNOx 2.0

is classified as follows:

1.7.



Class II / Intern

nally Powered, accord

ding to the ttype of prottection against electric

c

sho

ock



IP33, accordin

ng to the de

egree of pro

otection aga

ainst harmfu

ul ingress o

of water and

d

solid objects



Con

ntinuous op

peration for the mode o

of operation

n

Important Safety Con

nsiderations

s

Safety con

ncerns or ad

dditional pe

ertinent info

ormation will be displayyed using w

warnings,

cautions, and

a notes, having the following s ignificance:

A

Alerts to p

potential se

erious inju

ury,

a

adverse ev

vent, or sa

afety hazarrd.

A

Alerts to the possibilityy of minor iinjury or

damage to the equipm

d

ment.

Provides additional information to

o clarify

S:

NOTES

a point in th

he manual.

Th

he principal WARNING

G and CAUTION notices to be ob

bserved in u

use of this d

device are brought

tog

gether here

e for empha

asis.

Usse of the Ae

eroNOx 2.0

0 is contra

aindicated fo

or patients with conge

enital heart disease on

n right-to-lefft

sh

hunt, congenital anoma

alies, or con

ngestive he

eart failure.

Do

o not use th

he AeroNOx

x 2.0 in ox

xygen rich environmen

nts.

If a

an alarm oc

ccurs, safeg

guard patie

ent before trroubleshoo

oting or repa

air procedures.

Usse only pha

armaceutica

al grade NO

O.

Parrt No. 715-008

86, Rev. A

-4-

Page 8

The AeroNOx 2.0 must be used in accordance with indications, usage, contraindications, warnings,

and cautions described in this manual.

The use of devices which radiate high intensity electrical fields may affect the operation of the

AeroNOx 2.0. Constant assessment of the patient and all life support equipment is mandatory

whenever interfering devices are operating on or near patient.

When using the AeroNOx 2.0 adjacent to or stacked with other equipment, observe the operation of

the AeroNOx 2.0 and the other equipment to ensure normal operation.

Portable RF communications equipment (including peripherals such as antenna cables and external

antennas) should be used no closer than 30 cm to any part of the AeroNOx 2.0 and associated

cables. Otherwise, degradation of the performance of this equipment could occur.

Do not use the AeroNOx 2.0 with helium/oxygen mixtures. The AeroNOx 2.0 is only intended to

deliver NO in conjunction with oxygen/air mixtures.

Anytime a new NO gas cylinder and regulator is used, the user must purge to prevent inadvertent

delivery of NO2 to the patient.

If the AeroNOx 2.0 is not going to be used within 10 minutes, depressurize the regulator supply line.

If the AeroNOx 2.0 is pressurized and not used within 10 minutes, repeat the purge procedure.

If the AeroNOx 2.0 is not depressurized and not used within 12 hours, repeat the pre-use procedure.

A backup NO delivery system must always be available in the event the primary system should fail.

Set AeroNOx 2.0 alarm thresholds for the current patient conditions to monitor any inadvertent

changes in treatment. For alarm information, see Section 4., ALARMS.

Be certain all lines and cables are organized to prevent damage or occlusion.

Use only parts, accessories, transducers, and cables designated by International Biomedical for use

with the AeroNOx 2.0. Cables and accessories other than those supplied by International

Biomedical may result in unacceptable operation of the AeroNOx 2.0 and will void the equipment

warranty.

The AeroNOx 2.0 samples gas at a rate of 220 mL/min; this can affect the sensitivity of flow triggered

synchronized breath of some ventilators. The trigger sensitivity, if equipped, should be checked after

connecting AeroNOx 2.0 to the breathing circuit.

Do not change NO, NO2, or O2 sensors while in use.

Do not attempt to maintain, diagnose, or repair the AeroNOx 2.0 while delivering NO to a patient.

No modification of the AeroNOx 2.0 is allowed.

Improper sensor or battery replacement will result in a non-functional or inaccurate device.

Sample/Delivery accessories are single patient use only. DO NOT re-use.

Part No. 715-0086, Rev. A

-5-

Page 9

Im

mproper maiintenance or

o replacem

ment of sens

sors may p

pose a safetty risk to the patient. M

Maintenanc

ce

sh

hould be performed by qualified service pers

sonnel per tthe instructions.

Pe

erform cylin

nder connec

ction and pu

urge proced

dures in we

ell-ventilated areas to prevent ina

advertent

exxposure to nitric

n

oxide or nitrogen dioxide ga

as. Follow yyour facilityy’s safety prrocedures ffor handling

g

me

edical gas cylinders.

c

Ovverexposure to NO or NO2 can le

ead to physiiological efffects such a

as hypoxia which are not apparent

to the operato

or.

Th

he IP33 rating applies when the AeroNOx

A

2.0 is on ba

attery powe

er with the D

DC Input ja

ack properly

y

se

ealed.

aution: U. S.

S Federal and

a Canadian law res

stricts this d

device to sa

ale by or on the order o

of a physician

Ca

or other licensed medica

al practition

ner. Outside Canada a

and the U. S., check w

with local la

aws for

ap

pplicable res

strictions.

When using the

t AeroNO

Ox 2.0 Bagger or INO

Ostat Bagge

er, oxygen and NO mix in the resservoir bag. If

no

ot actively bagging

b

patient, turn NO

N flow off to

t prevent fformation o

of NO2. Flussh the bagg

ger for 20

se

econds befo

ore and afte

er use to co

ompletely re

emove NO a

and NO2.

Co

oncentration

ns of NO2 in the reserv

voir bag ma

ay exceed 1 ppm. Larrge tidal vo

olumes mayy expose

pa

atients to NO

O2 in the re

eservoir bag

g. If any intterruption o

occurs durin

ng patient b

bagging, syystem shoulld

be

e flushed for 20 second

ds.

When using the

t AeroNO

Ox 2.0 Bagger or INO

Ostat Bagge

er, short du

uration, rapid fluctuatio

ons in

de

elivered gas

s concentra

ation including NO2 is possible.

p

T

Therefore, the AeroNO

Ox 2.0 Bag

gger and

INOstat Bagg

ger are designed for sh

hort term us

se only.

Do

o not use AeroNOx

A

2.0

0 Bagger or INOstat Bagger to deliver con

ncentration in excess o

of 20 ppm.

Th

he generatio

on of NO2 increases ra

apidly abov

ve this conccentration.

Do

o not alter the length of

o the INOsttat Bagger gas supplyy tubing as tthis may ca

ause genera

ation of

exxcessive lev

vels of NO2.

Do

o not substiitute AeroN

NOx 2.0 Bagger or IN

NOstat Bagg

ger compon

nents. The

e Bagger Syystems hav

ve

be

een designe

ed and teste

ed for patie

ent safety with

w the com

mponents in

ncluded.

Th

he AeroNOx

x 2.0 Bag

gger and INOstat Bagg

ger are intended to con

nnect direcctly to the pa

atient’s

en

ndotracheal tube. Do not

n insert any

a addition

nal tubing between the

e Bagger an

nd the endo

otracheal tu

ube.

Th

he AeroNOx

x 2.0 Bag

gger and INOstat Bagg

ger are sing

gle patient u

use. Do no

ot reprocesss.

Th

he INOstat Kit is intend

ded for use if the prima

ary NO deliivery device

e (AeroNOxx 2.0) fails. The

INOstat Kit is

s not intended as a prim

mary NO de

elivery device.

Th

he back-up delivery reg

gulator in th

he INOstat Kit is prese

et with a 0.2

25 L/min flo

ow. It is inte

ended to be

e

ussed only witth the INOs

stat Bagger.. Do not us

se this regu

ulator for an

ny other app

plication.

Parrt No. 715-008

86, Rev. A

-6-

Page 10

Persons using the AeroNOx 2.0 should be trained and experienced in the use of this device to

assure effective administration of NO, and to avoid injury to the patient or to others resulting from

inhalation of excess NO, NO2, or other reaction products. Not for use by patients.

Persons using this device who may be particularly sensitive to nitric oxide or nitrogen dioxide, or who

may be exposed to these gases for prolonged periods as a result of the use of this device, should be

aware that the AeroNOx 2.0 does not scavenge the exhaust gas, and that this gas is vented from the

underside of the AeroNOx 2.0, or through the side vent in the event that the bottom port is occluded.

Ambient concentrations of nitric oxide or nitrogen dioxide expected to result from the use of this device

are less than 50 ppb.

Only use International Biomedical approved batteries for AeroNOx 2.0.

Even when the external power supply is not connected, the battery provides a bias charge to the NO,

NO2, and O2 cells to keep sensors in a ready state. The power drawn from biasing the sensors will

deplete a new fully charged battery in approximately one week. Because of this, it is recommended

the external power supply of the AeroNOx 2.0 remain plugged in at all times to maintain battery

charge.

Disconnect the battery or leave charging when not in use for extended periods of time.

Allowing the battery to fully discharge repeatedly will reduce the overall number of cycles in the life of

the battery.

Attempting to run the AeroNOx 2.0 for longer than five hours on battery only could result in an

interruption of nitric oxide therapy.

The specified power supply is defined as part of the ME Equipment. Use only the International

Biomedical approved universal power supply for AeroNOx 2.0.

No other devices are known to cause potential interference with the AeroNOx 2.0. If interference

occurs, discontinue use of the AeroNOx 2.0 and use the INOstat Bagger.

Never turn on the NO delivery gas without first turning on the ventilator or bagger flow. Failure to do

this will result in undiluted gas delivery entering the sampling chamber and exposing the sensors to

levels of NO and /or NO2 which may damage the sensors.

NO2 gas may have collected in the AeroNOx 2.0 delivery or ventilator circuit during setup. Run

ventilator and AeroNOx 2.0 on a test lung 30 seconds prior to patient connection to ensure analyzed

levels of NO2 and NO are appropriate.

Only use the NO Worries Sample line with filter and Nafion tubing when operating the AeroNOx 2.0.

Failure to do so may result in the egress of moisture which can impair function as well as damage

internal components.

NO flow must be continually evaluated during nitric oxide administration to ensure accurate dosing.

NO cannot be administered during the calibration process.

Do not sterilize or disinfect with power connected.

Part No. 715-0086, Rev. A

-7-

Page 11

Allow unit to dry thoroughly before use. Immediate use after exposure to excessive cleaning agents

such as Isopropyl Alcohol can affect sensor performance.

Do not push on LCD display.

The VESA 75 mount is required for mounting during transport.

Should there be a sudden need to change therapy tanks; a second tank should always be purged and

ready for immediate use. Perform the purge procedure immediately upon installation of a new

regulator.

The flush procedure must be performed each time NO therapy is started. This includes initial therapy

starts, tank changes, and re-starting therapy after NO has been off.

Powering the unit off will shut off the delivery gas flow. Gas flow is terminated when the unit is

powered off, whether intentionally, or during a complete loss of power.

DO NOT exceed 2.00 LPM as displayed on the AeroNOx 2.0 flow display. Displayed values in

excess of 2.00 LPM are not accurate. If the flow on the AeroNOx 2.0 flow meter is set at a value

greater than 2.00 LPM, the delivered flow will be higher than the displayed flow value.

The NO2 sensor may easily be damaged by inadvertent high levels of NO2. Use Nitrogen or air to

flush the system after high levels of NO (> 100 ppm) or NO2 (> 20 ppm) have been introduced to the

sensor.

Setting alarm limits to extreme values can render the alarm system useless.

After storage at the extremes of the allowable temperature range, it is recommended that the AeroNOx

2.0 be given at least an hour at room temperature before use.

NOTES:

The Low Cal does not require calibration gases.

Connections to various ventilators are unique to each manufacturer as well as their corresponding

disposable circuits.

When AeroNOx 2.0 is connected to a ventilator and patient is breathing spontaneously, a slight

change in NO ppm (< 10%) may be noted.

When performing high range calibration, make sure to select the correct calibration gas and confirm

expiration date before using.

Never connect calibration circuit to a pressure source > 50 cm H2O; this could damage the sampling

system.

Protective cover not shown in many images throughout this manual should be used at all times to

provide extra impact resistance if dropped.

AeroNOx 2.0 is shipped with battery uninstalled. Follow installation procedure in Section 7.

Part No. 715-0086, Rev. A

-8-

Page 12

Do not mount or position the AeroNOx 2.0 such that the rear power connection, exhaust ports, or the

NO inlet are blocked.

The recommended storage temperature limits are within operational temperature limits to preserve

sensor life. No specific time to cool or warm from storage temperature extremes is indicated. Before

normal use, a pre-check must be performed to allow sensors to stabilize.

Use the tethered rubber plug to seal the DC input jack from the environment when not in use.

Part No. 715-0086, Rev. A

-9-

Page 13

1.8.

Symbols

The follow

wing symbols appear in

n the AeroN

NOx 2.0 d

documentation and lab

bels.

“ON”//”OFF” Pow

wer (Hold fo

or ~3

Seco

onds to turn off)

S

Soft Key (3))

Silence Alarm Button

B

D

Date of Man

nufacture

Dim Backlight

B

Button

B

M

Manufacture

er contact

in

nformation

Back

k Button

G

General Wa

arning,

C

Caution, Rissk of Dange

er

NO Sample

S

Inle

et

D

Do not disca

ard in trash

NO/N

N2 Delivery Outlet

U

Use indicate

ed power

supply only

Nitric

c Oxide Flow

w Control

(Incre

easing flow

w counter clo

ockwise)

E

Exhaust Do Not Block

ATTE

ENTION: Observe precautions

for ha

andling elec

ctrostatic se

ensitive

devic

ces.

U

Use only the

e specified

re

eplacement battery.

sult Instructions For Us

se

Cons

N

NO/N2 Supp

ply Gas Input

Operrating press

sure limits

O

Operating te

emperature

limits

(Blue

B

Background

d)

Parrt No. 715-008

86, Rev. A

Type BF Applied Pa

art

Class II Equipment

Device serial

s

numb

ber

Prescriptiion use only

y

- 10 -

Page 14

Device part numbe

er

Decrea

ase Value

Confirmation

Set Low A

Alarm Limitt

Se

elect High/L

Low Alarm Limits

Set High Alarm Limit

Increa

ase Value

A

AC Power P

Plugged in and

a

Cha

arging

Ala

arm Tempo

orarily Silenced for

Approximat

A

tely 60 Sec

conds

Scree

en Lock

Batte

ery Level

Full / Low

Screen Un

nlock (Hold to

unlock)

Ho

old Button Timer

T

(Moving Pie

Chart)

C

Lock Prohibited with

h

unacknowlledged alarrm

Nitric

c Oxide Co

oncentration

n in Parts

Perr Million

Percen

nt Oxygen

Nitro

ogen Dioxid

de Concenttration in

Parts Per Million

Zero Calibrration Scree

en

Sofft Key

Sett NO=0, NO

O2=0, and %O

% 2=21

Soft Key (Hold to ze

ero)

High Calibrration Scree

en

Sofft Key

Parrt No. 715-008

86, Rev. A

- 11 -

Page 15

1.9.

Abbreviations

ABBREVIATION

AC

CISPR

cm

DC

ESD

FiO2

FSO

ft.

HFOV

IB

in

L/min

mA

mbar

mL/min

mm

mmHg

N2

NO

NO2

O2

PM

ppb

ppm

psi

psig

PTFE

RH

RF

V

VESA

Part No. 715-0086, Rev. A

DEFINITION

Alternating Current

International Special Committee on Radio Interference

Centimeters

Direct Current

Electrostatic Discharge

Fraction of Inspired Oxygen

Full Scale Output

Feet

High Frequency Oscillatory Ventilation

International Biomedical

Inches

Liters per Minute

Milliamps

Millibars

Milliliters per Minute

Millimeters

Millimeters of Mercury

Nitrogen Gas

Nitric Oxide Gas

Nitrogen Dioxide Gas

Oxygen Gas

Preventative Maintenance

Parts per Billion

Parts per Million

Pounds per Square Inch

Pounds per Square Inch Gauge

Polytetrafluoroethylene

Relative Humidity

Radio Frequency

Volts

Video Electronics Standards Association

- 12 -

Page 16

1.10. Regulators

s

Delivery, calibration,

c

and backup

p regulatorss are supplied with gauges displa

aying press

sure

in psig. Th

he sealing tips

t

are a wear

w

item th

hat require replacemen

nt periodica

ally or if

damaged. Note these tips are specific

s

to th

he bottle co

onnection tyype and mu

ust be

replaced accordingly

a

as shown in

i the table

e below. Se

ection 7., M

MAINTENAN

NCE contains

more information on replacemen

r

nt tips.

Delivery

(CGA 626)

731-914

42

Calibration

C

(CGA 625)

731-914

41

Backup

(CGA 626)

731-914

43

Replacement

Parts

Parrt No. 715-008

86, Rev. A

Se

eal Nipple (CG

GA 626)

731-937

74

GA 625)

Se

eal Nipple (CG

731-937

75

- 13 -

Page 17

1.11. Unpacking

Verify that the shipping carton contains the following equipment.

Component

Part Number

Quantity

AeroNOx 2.0

731-0426

1

AeroNOx 2.0 NO supply Hose, 6’

Battery Assembly (SLA or LiFePO4)

738-1862

1

888-0115 or 888-0013

1

AeroNOx 2.0 Multilanguage Documentation CD

717-0004

1

AeroNOx 2.0 Operator’s Manual

Delivery Regulator with CGA 626 Fitting

715-0086

1

731-9142

2

Power Supply Assembly, 9V, Locking, AeroNOx 2.0

Power Cord, NEMA 1-15P to IEC60320 C7, 6ft

738-1964

1

738-1916

1

AeroNOx 2.0 Service Manual

715-0088

1

AeroNOx 2.0 Sample/Delivery Kit

738-1853

1

AeroNOx 2.0 TXP HFV Sample/Delivery Kit

738-1854

1

AeroNOx 2.0 Test Circuit

738-1889

1

AeroNOx 2.0 Calibration Circuit*

738-1850

1

AeroNOx 2.0 Transport Mount, Adapter Block

731-0330

1

Power Cord, CEE 7/16 to C7, 2m, AeroNOx 2.0

738-1963

1

*Calibration requires a calibration regulator. An INOstat Backup Bagger kit is also required in

the event of AeroNOx 2.0 failure during use. If your hospital does not have each of these,

they must be purchased as separate items shown below. The same regulator may be used

for NO and NO2, but a purge procedure must be completed each time it is attached to a new

bottle of gas.

Component

Calibration Regulator with CGA 625 Fitting

INOstat Kit

Part Number

731-9141

731-9147

Quantity

1

1

1.12. Initial Setup

a.

Unpack the AeroNOx 2.0 and inspect for damage.

b.

Install battery as per Section 7., MAINTENANCE, “Battery Replacement”. The

AeroNOx 2.0 was shipped with an uninstalled battery for safety. The SLA and

LiFePO4 batteries are not interchangeable.

c.

Unpack 9 VDC power supply (P/N 738-1964) and Power Cord (P/N 738-1916 or

738-1963). Plug in AeroNOx 2.0 and charge for 48-72 hrs.

d.

Calibrate the AeroNOx 2.0. (See Section 6., CALIBRATION.)

e.

Perform Section 2., PRE-USE CHECKOUT/ALARM VERIFICATION, before

administering therapy to a patient.

f.

Install AeroNOx 2.0 per the appropriate situation described in Section 3.,

PATIENT OPERATIONS.

Part No. 715-0086, Rev. A

- 14 -

Page 18

1.13. Purge Procedure

Please follow purge instructions below to ensure gas purity. Failure to follow these

instructions may introduce potentially harmful contaminants into the patient’s breathing

gas or may affect the monitoring analyzer’s accuracy by introduction of contaminants into

the calibration gas.

Any time a regulator is installed on a tank or cylinder of compressed gas, certain

precautions must be followed. This is to prevent contamination of the gas in the tank and

in the system by air that is trapped in the dead space of the regulator, hose, and fittings.

To eliminate the possibility of the oxygen in this air reacting with the nitric oxide to form

nitrogen dioxide in the system, the regulator, hose, and fittings must be purged before

use. The valve on the tank must not be opened and left open until the regulator is

purged. The stainless steel hose must also be purged prior to connection to the

AeroNOx 2.0.

1.13.1. Purge Procedures for use with Medical Gas Regulators:

a.

Connect cylinder to a matching CGA 626 nitric oxide or nitrogen dioxide

regulator only.

b.

Connect stainless steel hose to quick disconnect.

c.

Open, then immediately close the cylinder valve pressurizing the hose.

d.

Purge (bleed) all of the gas from the regulator and hose with the purge

pin on the AeroNOx 2.0.

e.

Repeat steps c. and d. four more times for a total of five purge cycles.

f.

Leave the regulator installed until it is time to change to a new cylinder.

g.

Repeat the purge procedure any time a regulator is reattached.

Although the dead space volume in the regulator and hose assembly is physically small,

if it had been exposed to room air for a period of time it will contain sufficient oxygen to

convert a significant amount of nitric oxide to nitrogen dioxide.

Part No. 715-0086, Rev. A

- 15 -

Page 19

1.14. Front Pane

el

1

Samp

ple Line Inle

et

Sample

S

Line

e Filter Plug

gs Into Quicck Disconn

nect

2

Deliverry Line Outllet

Delivery Line Fitting

g

3

NO Flow Control

Setss NO Flow tto Delivery Outlet

4

Power

P

Turns Po

ower On/Offf

5

Maiin Screen

Displays Measured and Alarm Parameterrs

6

Alarm Silence Ke

ey

Sile nces Alarm

m For One M

Minute

7

Ba

acklight

Dim

ms Backligh

ht to 50% Normal

8

Back

Returns to previous scrreen

9

So

oft Keys

Variable Functtion Keys C

Correspond to Screen Menu

10

Charging Indicato

or

Green L

LED illumina

ates when p

plugged-in

11

Protective Coverr

Re

emovable im

mpact prote

ection

Parrt No. 715-008

86, Rev. A

- 16 -

Page 20

1.15. Rear Pane

el

1

NO/N2 Gas

s Inlet

Q

Quick Conn

nect for NO

O Gas Delive

ery

2

Purge Pin

P

Purge Pin

n for NO Delivery Line

e

3

Sen

nsor Housin

ng Cover

Houses NO

O, NO2, and

d O2 Senso

ors

4

Samp

ple Gas Exh

haust Ports

Gas Esccape for Inte

ernal Pump

p

5

Dove

etail Mountin

ng Bracket

6

Batttery Housin

ng Cover

Mou

unts AeroN

NOx 2.0 on Pole or H

Handle

Houses 6 volt B

Battery

7

Powerr Supply LE

ED Indicator

Indiccates if Unitt is Conneccted to A/C Power

8

Powe

er Supply Cord

C

Outlet

Pow

wer Supplyy Connectio

on w/Dust C

Cover

9

VESA 75

5 Mount (4  M4 Screw

ws)

Handle

e

75 mm  7

75 mm Mou

unting Patte

ern

Inttegrated Ha

andle

10

Parrt No. 715-008

86, Rev. A

- 17 -

Page 21

1.16. Navigating

g Display Sc

creens

There are two screen

ns that can be displaye

ed on the A

AeroNOx 2.0

0 NO deliivery system

m.

Main display screen and

a Calibra

ation screen

n.

1.16.1. Main Display Screen

On the main screen the

e operator ccan monitorr values and

d alarm me

essages.

1

Upper A

Alarm Limit

2

Lower A

Alarm Limit

3

Measurred Value

4

NO Flow R

Rate Displa

ay

5

Battery

B

Life or A/C Pow

wer

6

Alarm Settings

7

Messa

age Area

8

Screen L

Lock Statuss

Parrt No. 715-008

86, Rev. A

- 18 -

Page 22

1.16.2. Ca

alibration Mode Disp

play Screen

n

During the firrst five seco

onds of start-up, user has the option of ente

ering the

ca

alibration display scree

en. The ca

alibration sccreen lets th

he user sele

ect different

ca

alibration op

ptions whic

ch will be co

overed in Section 6.

1

NO Meassured Value

e

2

NO2 Meassured Value

e

3

O2 Meassured Value

e

4

Ro

oom Air Ca

alibration (Z

Zero)

5

NO

O, NO2, O2 Calibration

C

w

with Known

n Calibrated

d Gas

Parrt No. 715-008

86, Rev. A

- 19 -

Page 23

1.17. Universal Power Sup

pply

Desc

cription

The un

niversal pow

wer supply is

s both a

voltage

e source forr internal charging

and an

n AC power supply.

Illu

ustration

The intternal charg

ging circuit will

w

sense battery type

e and condittion and

adjust the charge as necessa

ary.

Even when

w

the ex

xternal powe

er

supply

y is not conn

nected, the battery

b

provide

es a bias ch

harge to the NO,

NO2, and

a O2 cells to keep sen

nsors in

a ready

y state. The

e power dra

awn

from biasing the sensors

s

will deplete

a new fully charge

ed battery in

n

approx

ximately one

e week. Because

of this, it is recommended the

e

externa

al power supply of the

AeroNOx 2.0 rem

main plugge

ed in at

es to mainta

ain battery charge.

c

all time

Conne

ect power su

upply to AerroNOx

2.0 by

b inserting power plug into the

DC jac

ck on the ba

ack side and

d

screwing the locking ring onto

o the

jack. A green LED

D light on th

he back

and the

e front indic

cates that the power

is supp

plied to the AeroNOx

A

2..0.

The po

ower supply

y is a non-ME

Equipm

ment element of the Ae

eroNOx

2.0 ME

M System. The power supply

has an

n IP rating of IP22. When not

connec

cted, use the tethered rubber

r

plug to

o seal the DC

C input jack

k from

the env

vironment to

o maintain the

t IP33

rating of

o the ME Equipment.

E

A low battery alarrm will alertt the

user when

w

there are

a approximately

15 min

nutes remaining. (See

e

Section 4., ALAR

RMS.)

Parrt No. 715-008

86, Rev. A

- 20 -

Page 24

Powe

er

State

e

OFF

OFF

ON

ON

ON

PO

OWER STAT

TES

LCD

Green LED

D

Indicator

Lights

LCD

D

DISPLAY

Extternal

Su

upply

Batte

ery

Stattus

Life

OFF

F

PLUG

GGED-IN

OFF

ON

CHARG

GING

IND

DEFINITE

OFF

F

UNPL

LUGGED

OFF

OFF

MAINTA

AINING

SENS

SOR

BIA

AS

~1 WEEK

ON

PLUG

GGED-IN

ON

CHARG

GING

IND

DEFINITE

ON

UNPL

LUGGED

OFF

SYST

TEM

RUNN

NING

~5 HOURS

???

PLUG

GGED-IN

ON

NO

OT

INSTAL

LLED!

INVALID!

IN

NSTALL

BA

ATTERY

???

1.18. Theory of Operation

The AeroN

NOx 2.0 NO

N delivery system pro

ovides a co

onstant dosse of NO ga

as into the

inspiratory

y limb of the

e ventilator circuit. The

e AeroNOxx 2.0 utilizzes a bi-logic design to

o

ensure saffe delivery of

o NO to the patient. F

First, a NO delivery logic system precisely

measures flow of NO to the venttilator circuit to mainta

ain an accurate NO levvel. Second

d,

a separate

e gas monittoring syste

em uses NO

O, NO2, and

d O2 sensorrs to continuously

measure and

a display concentrattions. The dual logic a

approach a

allows indep

pendent

delivery off NO and monitoring.

m

The dual lo

ogic also alllows the mo

onitoring syystem to sh

hut

down Aero

oNOx 2.0 delivery if it detects a fault in the

e delivery syystem (See

e Below). The

T

set-up deliivery and monitoring

m

is

s performed

d by a train

ned clinician

n.

1.

The

e cylinder re

egulator is attached

a

to

o the AeroN

NOx 2.0 viia stainlesss steel tubin

ng

to th

he NO/N2 quick

q

discon

nnect locate

ed on the b

back of the device.

2.

NO gas enters

s the back of

o the AeroN

NOx 2.0 tthen throug

gh a safety shut-off vallve

which is open during norm

mal operatio

on.

3.

A delivery line is placed in

n the inspirratory limb o

of the ventilator circuitt, between the

t

outllet and hum

midifier (if ap

pplicable). Based on the ventilattor flow, NO

O gas

con

ncentration, and desire

ed dose, the

e operator a

adjusts NO

O flow to rea

ach prescrib

bed

dos

se.

Parrt No. 715-008

86, Rev. A

- 21 -

Page 25

4.

5.

NO Gas Monitoring

-

 displays vvalues for N

NO and NO

O2 in parts p

per million

The AerroNOx 2.0

(ppm) and

a %O2. A sample lin

ne is placed

d in the insp

piratory limb of the

ventilato

or circuit at least 30 cm

m (12 in) do

ownstream of the delivvery line.

Sample

e gas is with

hdrawn from

m the breatthing circuitt and goes tthrough

Nafion dryer tubin

ng, a hydro

ophobic sma

all particle ffilter, a sam

mple pump,

and fina

ally through

h the gas m onitoring se

ensors.

-

The pum

mp ensures

s a sample gas flow ra

ate is mainttained to the

e monitorin

ng

sensors

s.

-

Gas mo

onitoring se

ensors are e

electrochem

mical; they a

are specificc to each ga

as

and pro

ovide an ele

ectronic sign

nal that when properlyy calibrated

d correlates to

the concentration of

o the gas p

present.

e operator should

s

face

e the AeroN

NOx 2.0 sccreen, mon

nitoring its sstatus during

The

norm

mal use.

Parrt No. 715-008

86, Rev. A

- 22 -