AeroNOx 2.0 Operators Manual Rev A

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

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TABLE OF CONTENTS 1.

2. 3.

4.

5.

GENERAL INFORMATION ... 3 1.1. Introduction ... 3 1.2. Intended Use ... 3 1.3. Medical Indication ... 3 1.4. Contraindication ... 3 1.5. Safety Summary ... 4 1.6. Classification ... 4 1.7. Important Safety Considerations... 4 1.8. Symbols ... 10 1.9. Abbreviations ... 12 1.10. Regulators ... 13 1.11. Unpacking ... 14 1.12. Initial Setup ... 14 1.13. Purge Procedure ... 15 1.14. Front Panel ... 16 1.15. Rear Panel ... 17 1.16. Navigating Display Screens ... 18 1.17. Universal Power Supply ... 20 1.18. Theory of Operation... 21 1.19. Environmental Effects ... 23 PRE-USE CHECKOUT/ALARM VERIFICATION ... 25 PATIENT OPERATIONS... 38 3.1. Before Operation... 38 3.2. Connection to Ventilator Circuit (General) ... 38 3.3. INOstat Bagger backup NO Delivery System ... 38 3.4. INOstat Kit Pre-Use Checkout ... 39 3.5. INOstat Kit Instructions for Use... 42 3.6. Connection to Various Breathing Systems ... 43 3.7. Connection DIAGRAM - ICU Ventilator Circuit ... 44 3.8. Connection DIAGRAM - Transport Ventilator Circuit ... 46 3.9. Connection Diagram - High Frequency TXP-2D Phasitron ... 48 3.10. Connection Diagram - AeroNOx 2.0 Bagger ... 49 ALARMS ... 50 4.1. General Alarm Information ... 50 4.2. Priority Alarms ... 50 4.3. Alarm Silencing ... 50 4.4. User Adjustable Monitor Alarms ... 51 4.5. Safety Shut Off ... 52 4.6. Alarm Table ... 53 CALCULATIONS & TROUBLESHOOTING ... 55 5.1. Calculations for Nitric Oxide Delivery ... 55

Part No. 715-0086, Rev. A

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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

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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

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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

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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

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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

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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

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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

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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

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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 -

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

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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

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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

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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

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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

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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

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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

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