International Biomedical AeroNOx Operating Manual

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

AeroNOx

Portable Nitric Oxide

Titration & Monitoring System



Where “NO Man

” has gone before.....

Operating Manual

0086



AeroNOx

Portable Nitric Oxide

Titration & Monitoring System

Operating Manual



Phone: (512) 873-0033



Toll Free: 1-800-433-5615



Fax: (512) 873-9090



E-Mail: sales@int-bio.com



Website: http://www.int-bio.com



Mailing address:

International Biomedical 8508 Cross Park Dr. Austin, TX 78754 USA



Authorized representative in Europe for Regulatory Affairs:

Emergo Europe Molenstraat 15 2513 BH The Hague, The Netherlands

Document No. 715-7000 Revision E Page 1 of 63

0086

Document No. 715-7000 Revision E Page 2 of 63

AeroNOx

Table of Contents

SECTION I - IMPORTANT INFORMATION ABOUT NITRIC OXIDE DELIVERY........................ 5

SECTION II - UNPACKING AND SET-UP INSTRUCTIONS .......................................................6

AeroNOx Transport P/N 731-9148..............................................................................................7

AeroNOx Bedside ..................................................................................................................... 15

AeroNOx

SECTION III - DEVICE DESCRIPTION...................................................................................... 23

General .......................................................................................................................................23

Recommended Use ....................................................................................................................23

Back-Up System .........................................................................................................................25

Titration Delivery System ............................................................................................................28

NO / NO

Electrochemical Sensors ............................................................................................................30

Analysis ......................................................................................................................................30

Alarms.........................................................................................................................................31

“Safety” Shut Off ......................................................................................................................... 31

Front Panel .................................................................................................................................32

Gas Connections ........................................................................................................................33

Quick Connect Gas Fittings ........................................................................................................33

Luer Lock Connections ...............................................................................................................34

Battery ........................................................................................................................................35

Universal Power Supply..............................................................................................................37

SECTION IV - SPECIFICATIONS .............................................................................................. 38

Functional Performance..............................................................................................................38

Physical Specifications ...............................................................................................................41

Safety..........................................................................................................................................41

SECTION V - CALIBRATION..................................................................................................... 42

AeroNOx



Portable Cylinder Cart and Platform.......................................................................... 21

and O2 Sampling.........................................................................................................29



Calibration Procedure ...............................................................................................43

SECTION VI - NITRIC OXIDE DELIVERY .................................................................................45

Inspiratory Limb NO Titration in Constant Flow Ventilators.........................................................45

Precautions for Inspiratory Limb NO Titration ............................................................................. 45

Ventilators Safe for Use with the AeroNOx...............................................................................45

Nitric Oxide Concentration Profiles .............................................................................................46

SECTION VII - CALCULATIONS & TROUBLESHOOTING ...................................................... 47

Calculations for Nitric Oxide Delivery.......................................................................................... 47

What is the diluted FiO

? ............................................................................................................ 49

Oxygen Index Calculation ...........................................................................................................49

Calculation of Cylinder Duration .................................................................................................51

How much calibration gas do I need?.........................................................................................52



AeroNOx

Document No. 715-7000 Revision E Page 3 of 63

Troubleshooting Guide..............................................................................................53

AeroNOx

Table of Contents

SECTION VIII - CLEANING & MAINTENANCE......................................................................... 57

Cleaning......................................................................................................................................57

Repairs and Replacement ..........................................................................................................57

Customer Service .......................................................................................................................57

Instructions for Disposal..............................................................................................................58

SECTION IX - WARRANTY .......................................................................................................59

SECTION X - COMPETENCY BASED PERFORMANCE CHECK-OFF TOOL......................... 61

Routine (Weekly) AeroNOx Calibration ....................................................................................62

AeroNOx Portable & Bedside Set-Up ....................................................................................... 63

Document No. 715-7000 Revision E Page 4 of 63

SECTION I - IMPORTANT INFORMATION ABOUT

NITRIC OXIDE DELIVERY

ATTENTION!

 AeroNOx Nitric Oxide Titration & Monitoring System delivers nitric oxide gas and

measures nitric oxide and nitrogen dioxide gas concentrations in parts per million (ppm).

 “Caution: U. S. Federal and Canadian law restricts this device to sale by or on the order

of a physician or other licensed medical practitioner. Outside Canada and the U. S., check with local laws for applicable restrictions.”

 “Persons using this device should be trained and experienced in the use of this device to

assure effective administration of nitric oxide, and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide, or other reaction products.”

 “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 does not scavenge the exhaust gas, and that this gas is vented from the underside of the AeroNOx, 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.”

WARNING

The use of oxygen increases the danger of fire. Auxiliary equipment producing sparks should

not be placed near the AeroNOx. Small quantities such as ether or alcohol left near the

AeroNOx can cause fire.

Classification

According to the standard EN60601-1 of the International Electrotechnical Commission, Medical electrical equipment, Part 1: General requirements for safety, the AeroNOx is classified as follows:

 Class I / Internally Powered, according to the type of protection against electric

shock.

 Ordinary, according to the degree of protection against harmful ingress of water.

 Continuous operation for the mode of operation.

Document No. 715-7000 Revision E Page 5 of 63

SECTION II - UNPACKING AND SET-UP INSTRUCTIONS

Verify that the shipping carton (s) contain one of the following groups of equipment. Complete descriptions of these groupings can be found in this section.

1. AeroNOx

Nitric Oxide Titration & Monitoring System

2. AeroNOx

Nitric Oxide Titration & Monitoring System



Transport, P/N 731-9148



Bedside Option

Document No. 715-7000 Revision E Page 6 of 63

The AeroNOx Transport P/N 731-9148

Nitric Oxide Titration & Monitoring System

Component Part Number Quantity

AeroNOx

SS Hose with Quick Connect (3 ft.) 731-9371 1

AeroNOx Operating Manual

AeroNOx Technical Manual

12 V Universal Power Supply 293-0040 1

Medical Grade Power Cord 711-0179 1

SS NO Transport Delivery Regulators, CGA 626 731-9142 2

AeroNOx “NO WORRIES” Connector Sample Pak

AeroNOx Calibration Circuit

Single Calibration Screwdriver 416-0010 1

731-9138 1

715-7000 1

715-7001 1

731-9373 1

415-0000 1

The AeroNOx must be used with calibration gas and accessories specified by the manufacturer.

Symbols

The following symbols appear in the AeroNOx documentation and labels. These internationally recognized symbols are defined by the International Electrotechnical Commission, IEC 417A and IEC 878 or by the Institute of Electrical and Electronics Engineers, 315(a).

Direct current

Positive to center pin, Negative to outer ring of connection

Recycle or dispose of properly, contains sealed lead batteries

Attention, consult accompanying documents

Document No. 715-7000 Revision E Page 7 of 63

The AeroNOx Transport P/N 731-9148

Nitric Oxide Titration & Monitoring System

Prepare the AeroNOx Transport Nitric Oxide

Titration & Monitoring System

for initial operation as follows:

1. Unpack the AeroNOx and inspect for damage.

2. Install battery as per SECTION III, “Battery”.

3. Unpack 12 V universal power supply (P/N 293-0040) and Medical Grade Power Cord (P/N 711-0179). Plug in AeroNOx and charge for ~ 24 hrs.

4. Calibrate AeroNOx. (See SECTION V.)

5. Attach CGA 626 regulators to the transport tanks as per “Purge procedures to follow when changing tanks and/or regulators” in this section.

6. Connect selected regulator outlet to the AeroNOx gas inlet using the stainless steel hose with quick connect adapters.

7. Turn on nitric oxide gas supply.



8. Attach the delivery line from the AeroNOx delivery line (P/N 415-0001) found in the AeroNOx

Bagger (See Diagram # 2) or the AeroNOx



“NO WORRIES” connector sample pak to the female luer connector marked “NITRIC OXIDE DELIVERY OUTLET” on the AeroNOx. Tee the other end of the delivery line into the patient breathing circuit at least 30 - 40 cm upstream of the sampling site (see Diagram # 1).

9. Attach the “NO WORRIES” sample line (P/N 415-0004) to the male luer connector marked “ANALYSIS SAMPLE INLET” on the AeroNOx.

10. Select the appropriate sample gas connector from your “NO WORRIES” connector sample pak and attach it to the free end of the sample line. *NB if attaching the sample line to the bagger, skip this step.

11. Connect the sample gas connector to the patient breathing circuit. The connector should be placed in the inspiratory limb, just prior to the patient wye connection (refer to Diagram # 1).

Connect the sample line to the sampling port on the bagger (see Diagram # 2).

12. “Flush” your system according to “Suggested flush procedure for the delivery portion of



the AeroNOx

system”, or according to the instructions for the AeroNOx Bagger.

13. You are now ready to deliver NO gas and sample mixed inspired gases.

CAUTION! Never turn on the NO delivery gas without first turning on the ventilator or bagger flow. Failure to do this will result in undiluted delivery gas entering the sampling chamber and exposing the sensors to levels of NO and/or NO

which may damage the

sensors.

CAUTION! NO2 gas may have collected in the AeroNOx delivery circuitry. Prior to delivering gas to the patient, “flush” your delivery system with fresh NO delivery gas. This should be repeated every time you begin NO gas administration. Analyze the gas for high NO

levels prior to

patient connection.

Document No. 715-7000 Revision E Page 8 of 63

Suggested “flush” procedure for the delivery portion of the AeroNOx system:

1. Set up the AeroNOx for delivery as outlined in “AeroNOx Transport Nitric Oxide Titration & Monitoring System for initial operation”.

2. Hook up the ventilator to a test lung (patient should be manually ventilated during this procedure and the ventilator parameters should be set to the patient’s pre-NO gas settings).

3. Inactivate the “Safety Shut Off” system by simultaneously depressing the NO and NO2 alarm silence buttons for 5 seconds or until the display reads “SAFETY OFF”. For more information on the “Safety Shut Off” system, see “Safety Shut Off” in SECTION III.

4. Turn on the NO gas flow to 2 lpm by turning the knob on the precision metering valve in a counter-clockwise direction. This knob is located in the bottom right hand quadrant of the front panel of the AeroNOx below the LCD flow display. Allow the gas to flow into the ventilator circuit.

5. As soon as the NO2 value has dropped to a stable level, allow the gas to run for an additional 3 seconds and then adjust the NO flow to the desired level (see SECTION VII Calculations for NO Delivery to determine flow required for desired NO concentration).

6. Re-activate the “Safety Shut Off” system by simultaneously depressing the NO and NO2 alarm silence buttons for at least 5 seconds or until the display reads “SAFETY ON”.

7. Once the desired NO concentration has been reached, ensure that NO2 level is acceptable for patient administration. Below you will find a table which will give you the approximate NO2 values you can expect for a given NO concentration and ventilator flow at an FiO2 of 1.0.

Minute Volume / Ventilator Flow

[NO] 5 10 15 20

5 ppm 10 ppm 20 ppm 40 ppm 80 ppm

0.5 0.1 0.1 0.1

0.5 0.2 0.2 0.1

0.5 0.3 0.2 0.2

0.8 0.6 0.4 0.4

2.0 1.5 1.2 1.1

NO2 in PPM

The table above is for reference only.

Factors such as the accuracy of the ventilator flow, percent error in delivery apparatus, and human error, may all affect the actual delivered patient dose. The calculated NO flow should be compared with the analyzed NO dose to confirm accurate NO dosing. Should the actual NO flow differ from the calculated NO flow by more than 10% beyond published specifications, the cause must be determined and corrected immediately. If the cause can not be immediately determined, ensure patient safety and contact International Biomedical at 1-800-433-5615 for further assistance.

8. Connect the patient to the ventilator and monitor according to study and/or institution protocol.

CAUTION! The flush procedure must be performed each time NO therapy is started. This includes initial therapy starts, tank changes, and restarting therapy after trials off NO.

Document No. 715-7000 Revision E Page 9 of 63

Purge Procedures to follow when changing tanks and/or regulators.

Important!

Purge Procedure Required before Use 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.

Warning: Perform cylinder connection and purge procedures in well-ventilated areas to prevent inadvertent exposure to nitric oxide or nitrogen dioxide gas. Follow your facility’s safety procedures for handling medical gas cylinders.

Purge Procedures for use with Medical Gas Regulators:

1. Connect cylinder to a matching CGA nitric oxide or nitrogen dioxide regulator only.

2. Open, then immediately close the cylinder valve.

3. Release (bleed) all of the gas from the regulator.

4. Repeat steps 2 and 3 four more times for a total of five purge cycles.

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

6. Repeat the purge procedure any time a regulator is reattached.

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 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 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 line must also be purged prior to connection to the AeroNOx.

CAUTION! 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.

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.

Document No. 715-7000 Revision E Page 10 of 63

The following purge procedure must be followed any time a regulator is installed on a tank of gas. It should be done immediately after connecting a regulator to a tank to avoid contaminating a tank of gas with the air trapped in the dead space of the regulator in the event someone turns on and leaves on the valve on the tank.

1. Install and tighten the regulator onto the tank.

2. Insert the quick-connect on one end of the stainless steel hose into the quick-connect fitting on the regulator. Leave the other end of the stainless steel hose free.

3. Crack open and immediately close the tank valve.

4. Gently press the center tip of the quick-connect on the free end of the stainless steel hose against a clean hard surface and allow the pressure to bleed to zero. A small amount of high concentration delivery gas will be released at 50 psig. Keep the hose away from patients and clinicians in order to avoid exposure to the gas.

5. Repeat Step 3 and Step 4 above five times (five complete purge cycles).

6. Connect equipment and open the tank valve as needed.

Any time a regulator is installed onto a cylinder and before each patient use, the AeroNOx system should be purged. - NO EXCEPTIONS!!

AeroNOx Bagger: Instructions for use with the AeroNOx (See Diagram # 2.)

CAUTION!

 Oxygen and Nitric Oxide mix in the reservoir bag and stagnant flow will cause NO2 to be

formed. Turn off NO flow when not actively bagging patient. Flush the bagger with oxygen for a least 20 seconds to completely remove NO and NO2 before and after patient use.

 Concentrations of nitrogen dioxide in the reservoir bag may exceed 1 ppm. Large tidal

volumes may expose patients to the nitrogen dioxide in the reservoir bag.

 Flush the bagger with oxygen for at least 20 seconds to completely remove NO and NO

after any

interruption in active patient bagging.

 The AeroNOx may not be able to detect rapid, short acting fluctuations in the

concentration of the delivered gas, including nitrogen dioxide. For this reason, the AeroNOx Bagger is designed for short-term use only.

 If a patient requires nitric oxide concentrations other than 20 ppm, a separate system

capable of providing the required concentration must be available. DO NOT USE THE AERONOX BAGGER TO DELIVER CONCENTRATIONS IN EXCESS OF 20 PPM! The generation of nitrogen dioxide increases rapidly above this concentration.

 Do not alter the length of the Bagger Gas Supply Tubing as this may cause generation of

excessive levels of nitrogen dioxide.

Document No. 715-7000 Revision E Page 11 of 63

 Do not substitute AeroNOx Bagger components! The AeroNOx Bagger has been

designed and tested for patient safety with the components included in the current configuration.

 The AeroNOx Bagger is designed for use only with the AeroNOx Delivery System. Do

not attempt to use the AeroNOx with any other manual resuscitator. Do not attempt to use the AeroNOx Bagger with any other delivery system.

 A backup system must always be available in the event that the primary system should

fail. For instructions for use of a Back-Up System in the event of a failure of the AeroNOx system, please see SECTION III, Back-Up system.

 The AeroNOx Bagger is intended to be connected directly to the patient’s endotracheal

tube. Do not insert any additional tubing between the AeroNOx Bagger and the endotracheal tube.

 The AeroNOx Bagger is for single patient use only. Do not reprocess.

 Persons using this device should be trained and experienced in the use of this device to

assure affective administration of nitric oxide, and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide, or other reaction products.

 Persons using this device who may be particularly sensitive to nitric oxide, 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 gases exiting the AeroNOx Bagger are not scavenged.

1. Connect the large end of the bagger gas supply tubing to an oxygen source. Ensure that the small end of this tubing is connected to the NO / O2 gas inlet port on the bagger.

2. Connect AeroNOx Bagger gas delivery line to the AeroNOx delivery gas port.

3. Connect male end of the sample line (P/N 415-0004) to the sampling port on the bagger



gas supply tubing and the female end to the AeroNOx

sampling port.

4. Set O seconds to flush out any residual NO or NO

flow on the O2 flow meter to exactly 10 LPM. Let the oxygen run for at least 20

left in the AeroNOx Bagger.

5. Turn on NO delivery gas source to 0.25 LPM. If you have correctly set your O exactly 10 LPM, the delivered NO concentration will be ~20 ppm and delivered NO

flow at

values should not exceed 0.2 ppm. Do not exceed 20 ppm during manual ventilation!

6. Connect test lung and set overflow valve to desired positive end expiratory pressure (PEEP).

Document No. 715-7000 Revision E Page 12 of 63

7. Continue to run the AeroNOx Bagger with the test lung until the analyzed NO and NO values stabilize. This will prevent high doses of NO

, which can form in the bagger and

delivery line, from being delivered to your patient. The NO2 sensor in the AeroNOx Bagger may not react quickly enough to detect NO2 boluses. If you do not have time to use a test lung, in an emergency situation for example, you must still flush the

bagger with fresh gas for at least 20 seconds prior to patient connection!

8. Analyze NO and NO

concentration prior to patient administration.

9. Flush bagger with O

formation.

after each patient use to flush out residual NO and prevent

AeroNOx Bagger Specifications:

O2 Gas Flow

NO Gas Flow

Delivered [NO]

NO2 Generated

Reservoir Volume

Bagger Dimensions

Tidal Volume

Maximum 0.2 ppm @ 20 ppm Delivered [NO]

12” from Reservoir Bag to Patient Connection, ½” I. D.

Maximum 0.5 L (500 cc)

10 LPM

0.25 LPM ~ 20 ppm

0.5 L

Maximum 100 bpm at Pressures 18/5 (pip/peep)

Breath Rate

Maximum 50 bpm at Pressures 40/5

(Pressures Listed in cmH2O)

I:E Ratio

Variable

Diagram # 1

 NO Titration with a Transport Ventilator

Document No. 715-7000 Revision E Page 13 of 63

Diagram # 2 NO Titration with AeroNOx Bagger

Document No. 715-7000 Revision E Page 14 of 63

The AeroNOx Bedside

Nitric Oxide Titration & Monitoring System

Component Part Number Quantity

AeroNOx

AeroNOx Operating Manual

AeroNOx Technical Manual

AeroNOx Cart including Stand, Platform, Basket, & Power Bar

AeroNOx Mounting Block

731-9138 1

715-7000 1

715-7001 1

12 V Universal Power Supply 293-0040 1

SS Hose with Quick Connect Fittings 731-9371 1

Medical Grade Power Cord 711-0179 1

CGA 626 NO Delivery Regulators 731-9142 2

AeroNOx “NO WORRIES” Connector Sample Pak

AeroNOx Calibration Circuit

731-9373 1

415-0000 1

Single Calibration Screwdriver 416-0010 1

Recommended Bedside Gases: (Not Included)

Concentration: 800 ppm NO in balance N2 of pharmaceutical

grade gas

Size: 38” (1 meter) height by 7” (18 cm) diameter

The AeroNOx must be used with calibration gas and accessories specified by the manufacturer.

Document No. 715-7000 Revision E Page 15 of 63

The AeroNOx Bedside Set-Up

Prepare the AeroNOx Bedside Nitric Oxide Titration & Monitoring System

for initial operation as follows:

1. Unpack the AeroNOx



and inspect for damage.

2. Install battery as per SECTION III, “Battery”.

3. Secure the therapeutic tanks to the AeroNOx cart.

4. Unpack 12 V universal power supply (P/N 293-0040) and Medical Grade Power Cord (P/N 711-0179). Plug in AeroNOx and charge for ~ 24 hrs.



5. Calibrate AeroNOx Gas specified by the manufacturer and the instructions found in

using the Calibration Kit (P/N 731-9145) NO and NO2 Calibration

SECTION V of this manual.

6. Attach CGA 626 regulators (P/N 731-7142) to delivery gas cylinders as per “Purge procedures to follow when changing tanks and/or regulators” in this section.

7. Connect selected regulator outlet to the AeroNOx gas inlet using the stainless steel hose with quick connect adapters.

8. Turn on nitric oxide gas supply.

9. Attach the AeroNOx delivery line (P/N 415-0001) found in the AeroNOx “NO WORRIES” connector sample pak to the female luer connector marked “NITRIC OXIDE DELIVERY OUTLET” on the AeroNOx. Tee the other end of the delivery line into the patient breathing circuit at least 30 - 40 cm upstream of the sampling site. Attach the “NO WORRIES” sample line (P/N 415-0004) to the male luer connector marked “ANALYSIS SAMPLE INLET” on the AeroNOx.

10. Select the appropriate sample gas connector from your “NO WORRIES” connector sample pak and attach it to the free end of the sample line.

11. Connect the sample gas connector to the patient breathing circuit. The connector should be placed in the inspiratory limb, just prior to the patient wye connection (refer to Diagram # 3).

12. “Flush” your system according to “Suggested “flush” procedure for the delivery portion of the AeroNOx system”.

13. You are now ready to deliver NO gas and sample mixed inspired gases.

which may damage the sensors.

CAUTION!

gas may have collected in the AeroNOx delivery circuitry. Prior

to delivering gas to the patient, “flush” your delivery system with fresh NO delivery gas. This should be repeated every time you begin NO gas administration. Analyze the gas for high NO

levels prior to

patient connection.

Document No. 715-7000 Revision E Page 16 of 63

Suggested “flush” procedure for the delivery portion of the AeroNOx system:

1. Set up the AeroNOx for delivery as outlined in “AeroNOx Bedside Set-Up”.

2. Hook up the ventilator to a test lung (patient should be manually ventilated during this procedure and the ventilator parameters should be set to the patient’s pre-NO gas settings).

3. Inactivate the “Safety Shut Off” System by simultaneously depressing the NO and NO2 alarm silence buttons for 5 seconds or until the display reads “SAFETY OFF”. For more information on the “Safety Shut Off” system, see “Safety Shut Off” in SECTION III.

6. Re-activate the “Safety Shut Off” system by simultaneously depressing the NO and NO2 alarm silence buttons for at least 5 seconds or until the display reads “SAFETY ON”.

7. Once the desired NO concentration has been reached, ensure that NO2 level is acceptable for patient administration. Following, you will find a table which will give you the approximate NO2 values for a given NO concentration and ventilator flow at an FiO2 of

1.0.

Minute Volume / Ventilator Flow

[NO] 5 10 15 20

5 ppm 10 ppm 20 ppm 40 ppm 80 ppm

0.5 0.1 0.1 0.1

0.5 0.2 0.2 0.1

0.5 0.3 0.2 0.2

0.8 0.6 0.4 0.4

2.0 1.5 1.2 1.1

NO2 in PPM

The table above is for reference only.

Factors such as the accuracy of the ventilator flow, percent error in delivery apparatus,



human error, and accuracy of calibration of the AeroNOx

may all affect the actual delivered patient dose. The calculated NO flow should be compared with the analyzed NO dose to confirm accurate NO dosing. Should the actual NO flow differ from the calculated NO flow by more than 10% beyond published specifications, the cause must be determined and corrected immediately. If the cause can not be immediately determined, ensure patient safety and contact International Biomedical at 1-800-4335615 for further assistance.

8. Connect the patient to the ventilator and monitor according to study and/or institution protocol.

CAUTION! The flush procedure must be performed each time NO therapy is started. This includes initial therapy starts, tank changes, and restarting therapy after trials off NO.

Document No. 715-7000 Revision E Page 17 of 63

Diagram # 3 AeroNOx Bedside Set-Up

The Sensormedics 3100A or 3100B

To set up the AeroNOx for use with the 3100A & 3100B, tee in the AeroNOx Delivery Line (P/N 415-0001) immediately post humidifier. To connect the “NO WORRIES” sample line, you will require the 3100A / 3100B sample port adapter (P/N 415-0009). The port can be placed in one of three positions. All three positions are labeled as “temperature probe ports” in the 3100A / 3100B literature. The “set back” temperature port is pictured in Figure 1 and Figure 2. The proximal temperature port is pictured in Figure 3. The third port (not shown) is the second proximal temperature probe port located next to the “dump valve” on the inspired limb of the flexible circuit.

Document No. 715-7000 Revision E Page 18 of 63

Sampling Ports for the Sensormedics 3100A / 3100B:

Figure 1 The “Set Back” Temperature Probe Port

Figure 2 The “Set Back” Temperature Probe Port

Document No. 715-7000 Revision E Page 19 of 63

Figure 3 The Proximal Temperature Probe Port

Document No. 715-7000 Revision E Page 20 of 63

AeroNOx

Portable Cylinder Cart and Platform

Initial Set-Up: See package insert for complete instructions.

 Tools Required: Allen key (supplied)

1. Remove screws (Item 11) from base pole.

2. Lift support wheel (Item 9) so hole locations in base pole and support wheel pole (Item 7 & 9) are aligned.

3. Insert screw (Item 11) and tighten securely into base pole.

4. Attach basket assembly to tank bracket via the four button head 10-32  5/16 screws (Item 22) provided.

 The AeroNOx Cart is a strong six-wheeled cart with two locking wheels. It can hold two

2040 L Aluminum cylinders which are ~ 38” (1 meter) in height and ~ 7” (18 cm) in diameter.

 Beneath the basket holder is a medical grade 120 V power bar with a 3 prong plug and

four power outlets.

 The AeroNOx platform has a handle to allow movement of the cart, and a hook designed

to mount to the bed’s foot or headboard which allows the cart, cylinders, and AeroNOx system to be transported with the patient within the hospital. (See Diagram # 5.)

 The AeroNOx unit is attached to the cart platform by a metal block which fits into a ½”

hole in the black platform. The AeroNOx aluminum sliding bracket, allowing secure bedside use and quick disconnect capabilities.

(See Diagram # 4.)

Document No. 715-7000 Revision E Page 21 of 63

Description



unit is secured onto the mounting block by an



Diagram # 4

Room to Room Transport with the AeroNOx & Cart

The AeroNOx bedside system and tanks can be moved short distances with the patient by hooking the black platform onto the bed’s foot or head board, and raising the bed slightly, so as to partially un-weight the wheels.

Diagram # 5

AeroNOx & Cart (tanks not shown for clarity) ready to attach to the bed in the lowered position.

AeroNOx and Cart partially lifted by raising the bed when the cart is attached to the bed rail.

CAUTION!



A fully loaded AeroNOx

system with tanks weighs over 150 lbs (~ 68 kgs). Do not use the bed to lift the system completely off of the floor due to risk of serious injury to the patient, clinicians, or damage to the bed.

Stability & Safety:

The cart and monitor platform are designed to be stable when a NO cylinder is strapped to the cart. The unit occupies minimal floor area at the bedside, and can be placed behind or beside the mechanical ventilator.

CAUTION! Support the cart when changing out tanks at the bedside.

Document No. 715-7000 Revision E Page 22 of 63

SECTION III - DEVICE DESCRIPTION

General

The AeroNOx (NO), nitrogen dioxide (NO2) and oxygen (O2) analyzer. The AeroNOx is a stand-alone, lightweight, portable unit designed to continuously monitor NO, NO2, and O2 concentrations in a breathing circuit. The AeroNOx system is specifically designed for the delivery and monitoring of gaseous nitric oxide (NO) in parts per million (ppm) concentrations. The construction materials are compatible with NO and will not contaminate the gas stream.



system includes an integrated nitric oxide gas delivery system and nitric oxide

Recommended Use:

The AeroNOx Portable Nitric Oxide Titration & Monitoring System is designed for use with continuous flow systems as either a:

 Primary nitric oxide delivery system  Transport system  Backup delivery system in case of emergency  The AeroNOx has been tested for use with the AeroNOx Bagger, the Bird VIP (in

continuous flow modes only), the Sechrist 100IVB, the SensorMedics 3100A & 3100B, the Infant Star 100 Neonatal Ventilator, the MVP-10 Ventilator, the CV2i Ventilator, and the Percussionaire Bronchotron Ventilator.

 The AeroNOx is not MRI compatible.

Document No. 715-7000 Revision E Page 23 of 63

Diagram # 6 The INOstat Flow Inflating Bagger:

Use as a back-up system (independent of the AeroNOx system).

Document No. 715-7000 Revision E Page 24 of 63

Back-Up System:

An alternate means of delivering nitric oxide to your patient must be available should your primary system fail. For this reason International Biomedical has an available back-up system, the INOstat Kit (P/N 731-9147), for use in the event that your AeroNOx system should fail. This system consists of a flow inflating bagger, and a specially designed regulator with a preset NO delivery flow of 0.25 LPM.

Check INOstat Kit or other back up system for the AeroNOx for

functionality on initial set up and periodically during use.

To ensure that the back up system to the AeroNOx is always ready for emergency use, the functionality of the system should be confirmed on initial set up and periodically during use.

To check the functionality for INOstat Kit baggers, follow the instructions provided in the package inserts. These instructions read:

Set Up:

1. Connect the large end of the bagger gas supply tubing to an oxygen source. Ensure that the small end of this tubing is connected to the NO/O

2. Connect the back up delivery regulator (P/N 731-9143) to the INOstat NO gas delivery line.

3. Ensure that the sampling port on the bagger gas supply tubing is capped.

4. Place the system in a place that is readily accessible in the event of an emergency.

CAUTION! Confirm that the system is functional and delivering 20 ppm on initial set up by connecting the sampling system of the AeroNOx periodically.



to the port that is normally kept capped on the bagger. Recheck functionality

CAUTION!

 Oxygen and Nitric Oxide mix in the reservoir bag and stagnant flow will cause NO2 to be

formed. Turn off NO flow when not actively bagging patient. Flush the bagger with oxygen for at least 20 seconds to completely remove NO and NO2 before and after patient use.

 Concentrations of nitrogen dioxide in the reservoir bag may exceed 1 ppm. Large tidal

volumes may expose patients to the nitrogen dioxide in the reservoir bag.

 Flush the bagger with oxygen for at least 20 seconds to completely remove NO and NO

after any

interruption in active patient bagging.

 Rapid, short acting fluctuations in the concentration of the delivered gas, including

nitrogen dioxide are possible. For this reason, the INOstat Bagger is designed for short-term use only.

gas inlet port on the bagger.

Document No. 715-7000 Revision E Page 25 of 63

 If a patient requires nitric oxide concentrations other than 20 ppm, a separate system

capable of providing the required concentration must be available. DO NOT USE THE INOSTAT BAGGER TO DELIVER CONCENTRATIONS IN EXCESS OF 20 PPM! The generation of nitrogen dioxide increases rapidly above this concentration.

 Do not alter the length of the Bagger Gas Supply Tubing as this may cause generation of

excessive levels of nitrogen dioxide.

 Do not substitute INOstat Bagger components! The INOstat Bagger has been

designed and tested for patient safety with the components included in the current configuration.

 A backup system must always be available in the event that the primary system should

fail.

 The INOstat Bagger is intended to be connected directly to the patient’s endotracheal

tube. Do not insert any additional tubing between the INOstat Bagger and the endotracheal tube.

 The INOstat Bagger is for single patient use only. Do not reprocess.

 The INOstat Kit is for use only in the event of primary nitric oxide delivery device

(AeroNOx) failure and is not intended for use as a primary system.

 The Back-Up delivery regulator in the INOstat Kit has a preset flow and is for use only

with the INOstat Bagger. Do not attempt to use this regulator as a delivery regulator for any other application.

 Persons using this device should be trained and experienced in the use of this device to

assure affective administration of nitric oxide, and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide, or other reaction products.

 Persons using this device who may be particularly sensitive to nitric oxide, 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 gases exiting the AeroNOx

Bagger are not scavenged.

When used according to the instructions in this manual, the INOstat Kit will deliver a fixed concentration of 20 ppm NO ( 4 ppm). For this reason, the INOstat Kit should be used only during periods when the AeroNOx



has failed or cannot be used for other unanticipated

reasons, unless the patient is known to have no adverse effects at 20 ppm.

Document No. 715-7000 Revision E Page 26 of 63

INOstat Kit: Instructions for Use

Your back-up system should be set up and ready for use at all times during inhaled nitric oxide therapy. Clinicians should familiarize themselves with the use of the INOstat Kit. The adjustable overflow valve in the flow inflating manual resuscitator (Bagger) will help to control the amount of PEEP delivered. It is adjusted by turning the valve to adjust the size of the opening to atmosphere.

Set-Up:

1. Connect the large end of the bagger gas supply tubing to an oxygen source. Ensure that the small end of this tubing is connected to the NO/O2 gas inlet port on the bagger.

2. Connect the back-up delivery regulator (P/N 731-9143) to the INOstat NO gas delivery line.

3. Ensure that the sampling port on the bagger gas supply tubing is capped.

4. Place the system in a place that is readily accessible in the event of an emergency.

Using the Bagger:

1. Start the oxygen flow at exactly 10 LPM.

2. Open up the valve on the back-up delivery gas cylinder. NO flow is preset at 0.25 LPM.

3. Allow 20 seconds for the combined gas supply to flow freely from the bagger. This will flush out any residual NO2 that may have formed in the bagger or delivery system since the bagger was last used.

4. Begin manually ventilating your patient. If you have properly set the O2 flow at exactly 10 LPM, the delivered NO dose will be ~ 20 ppm.

5. Once you are finished using the bagger, turn off the NO gas flow and run O2 through the bagger (for at least 60 seconds) to flush out any residual NO or NO2.

INOstat Bagger Specifications:

O2 Gas Flow

NO Gas Flow

Delivered [NO]

NO2 Generated

Reservoir Volume

Bagger Dimensions

Tidal Volume

Maximum 0.2 ppm @ 20 ppm Delivered [NO]

12” from Reservoir Bag to Patient Connection, ½” I. D.

Maximum 0.5 L (500 cc)

10 LPM

0.25 LPM ~ 20 ppm

0.5 L

Maximum 100 bpm at Pressures 18/5 (pip/peep)

Breath Rate

Maximum 50 bpm at Pressures 40/5

(Pressures Listed in cmH2O)

I:E Ratio

Variable

Document No. 715-7000 Revision E Page 27 of 63

Titration Delivery System

Nitric oxide gas is regulated to 50 psig by a CGA 626 nitric oxide regulator. It is then delivered via stainless steel high pressure hose to the AeroNOx unit. (See Diagram # 7.) A precision metering valve (controlled by the operator on the front panel) regulates the NO gas flow to the patient circuit.

CAUTION! 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.

The NO gas flow is measured by a mass flow meter before it is delivered via the “NO WORRIES” delivery line (P/N 415-0001) into the breathing circuit. The mass flow meter’s range is from 0 - 2 LPM in 10 mL/min (0.01 LPM) increments.

CAUTION! DO NOT exceed 2.00 LPM as displayed on the AeroNOx flow meter digital display. Displayed values in excess of 2.00 LPM are not accurate. If the flow on the AeroNOx flow meter is set at a value greater than 2.00 LPM, the delivered flow will be higher than the displayed flow value.

The suggested titration point is in the inspiratory circuit at least 30 - 40 cm upstream of the sampling site. The high concentration source gas (~800 ppm NO, balance N2) is diluted in the breathing circuit’s air / oxygen mixture to the desired dosage.

This distance is required to ensure complete mixing of the nitric oxide with the carrier gas. Distances greater than 30 - 40 cm may increase the amount of NO2 generated.

The initial nitric oxide flow rate required to get a desired [NO] can be estimated from the following dilution formula. For more information, see Troubleshooting.

NO Flow (LPM) =

Vent Flow (LPM)  [NO] Desired

Source [NO] in Tank

SECTION VII, Calculations and

Document No. 715-7000 Revision E Page 28 of 63

NO / NO2 and O2 Sampling

The AeroNOx system continuously draws a mixed gas sample @ ~ 150 mL/min from the breathing circuit at a point in the inspiratory circuit nearest the patient connection. (See Diagram # 7.) The sample is drawn through a Nafion gas drying element, which removes water vapor only, using a patented electrically charged membrane. The dry sample gas is then drawn through a 5 micron hydrophobic filter into the device and into the sensor housing where gas analysis of NO (ppm), NO2 (ppm) and O2 (%) takes place.

CAUTION! Do not use the AeroNOx without the “NO WORRIES” sample line (P/N 415-0004) which includes both the Nafion filter for removing condensing humidity from the sample gas. Failure to do so may impair the function of the AeroNOx as well as decrease the life of the internal components. WARRANTY MAY NOT BE HONORED FOR DAMAGE CAUSED IN THIS MANNER!

Diagram # 7 AeroNOx: Gas Supply, NO Delivery, and Gas Sampling



tubing and the hydrophobic

Document No. 715-7000 Revision E Page 29 of 63

Sensors

The AeroNOx is supplied with one nitric oxide sensor and one nitrogen dioxide sensor in the delivery & analysis module. AeroNOx sensors are designed to provide trouble-free use for about twelve (12) months. Lifetime of the AeroNOx sensor will depend entirely on the concentration of NO or NO2 being analyzed. The normal lifetime is about 1000 hours of continuous use when exposed to 100 ppm NO and 10 ppm NO2 respectively.

The AeroNOx sensors must have a bias voltage going to them at all times. The battery must be charged in order to maintain this “bias voltage”. The AeroNOx maintains this voltage even when the power button is in the “off” position. This means that the battery is being drained even when the unit is powered off. For this reason, it is recommended that the AeroNOx be plugged in whenever possible to avoid the possibility of draining the battery to the point where it can no longer maintain the “bias voltage” necessary to keep the sensors in a ready state.

Unbiased sensors will need up to 48 hours to fully bias. This applies to the installation of new sensors as well as to sensors which have lost their bias due to a loss of battery power. Unbiased sensors will read a value greater than zero when exposed to room air. This value will continue to drop as the sensor biases. Once the value has dropped to zero, the AeroNOx must be re-calibrated prior to use.

CAUTION! 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.

CAUTION! Condensing humidity will impair the function of the AeroNOx sensors. Use only “NO WORRIES” sampling line (P/N 415-0004) which utilizes Nafion tubing to prevent condensing humidity from reaching the sensors. In the unlikely event that the sensor(s) gets wet, turn the unit on and



sample dry room air to allow the AeroNOx module to dry out.

Once dry, the AeroNOx

delivery & analysis



sensors will function

normally.

Analysis

Electrochemical sensors in the AeroNOx measure NO and NO2 concentrations in parts per million (ppm). NO values are displayed to the nearest ppm while NO2 values are displayed to the nearest tenth (0.1) parts per million. The electrochemical sensors operate by allowing NO and NO2 molecules to diffuse across a membrane located on the top of the sensor. Once inside the cell, these molecules react in an electrolyte solution augmenting an electrical current between an anode and a cathode. The augmented current is proportional to the NO or the NO2 concentration. The AeroNOx



also samples oxygen % for added safety.

Document No. 715-7000 Revision E Page 30 of 63

Alarms

The AeroNOx unit has adjustable alarm limits for NO & NO2. Audible and visual alarms are activated at the value that is set by the user, with the exception of the NO2 high alarm setting which can manually be adjusted to 99 ppm, but has a factory set default alarm of 11 ppm should the user set the alarm at 11 or higher. By carefully choosing alarm limits, any deviations in NO or NO2 concentrations will be known as soon as possible.

CAUTION! There are no alarms for the oxygen analysis portion of the AeroNOx. An auxiliary oxygen analyzer, such as the MiniOX 3000 by MSA, with audible and visual alarms must be used in conjunction with the AeroNOx.

Safety Shut Off

For patient safety, the AeroNOx has incorporated a “safety” shut-off system for the delivery of NO gas. The system is designed to avoid inadvertent high doses of NO being delivered to the patient by terminating the flow of NO gas to the delivery line. The system is activated when the NO dose analyzed is 5 ppm above that which has been set as the high NO alarm (or 100 ppm whichever is the lesser value) and 1 ppm above that set for the high NO2 alarm (or 12 ppm whichever is the lesser value). The system is designed to restore the flow of gas to the delivery line once the analyzed NO and/or NO2 values drop back to below the 5 ppm above and 1 ppm above alarm values. The default setting for this alarm is “activated”, that is, no action is required by the user to enable the safety system. To verify that the system is activated, simultaneously depress the NO and NO2 alarm silence buttons. The display will read “SAFETY ON”. Do not

depress the alarm silence buttons for more than 4 seconds as this will disable the “safety” shut-off system!

Should the “safety” shut-off system be triggered, (that is, an alarm condition has occurred) there will be an audible as well as a visual alarm, and the display will alternately read “NITRIC OFF” and the sensor data.

Your patient will not receive any NO gas from the AeroNOx condition!

It is recommended that you manually ventilate your patient with a system such as the INOstat Kit, capable of delivering a safe and known concentration of NO to your patient, while you troubleshoot the system to determine why the “safety” shut-off system was triggered. For information on the INOstat Kit back-up delivery system, see SECTION III, Back-Up System.

To override the system, simultaneously depress the alarm silence buttons for 5 seconds. The display will read “SAFETY ON” until 5 seconds have elapsed at which time it will read “SAFETY OFF”. At this point, the “safety” shut-off system has been inactivated. During the time that this system remains inactivated, the display will alternately display the “SAFETY OFF” message and the sensor data. To restore the “safety” shut-off to the activated mode, you may either simultaneously depress the alarm silence buttons for 5 seconds, or you may power the machine off and then back on again.



system during this

Document No. 715-7000 Revision E Page 31 of 63

Diagram # 8 AeroNOx Front Panel

AeroNOx Front Panel

CONTROL FUNCTION

1. Display of NO & NO2 in ppm

2. “Zero” NO & NO2

3. Power

4. LITE

5. HIGH / LOW Adjustable Alarm Settings

6. Alarm Silence

7. Cal. NO & Cal. NO2 Calibration Pots

8. Oxygen %

9. O2 Cal. Pot.

10. NO Flow Meter

11. NO Flow Control

12. Check Sample Line

Back-lit, digital liquid crystal display of NO and NO2 ppm, calibration status and battery condition. (See “Battery” SECTION III.) A “plug” character in the display indicates that the wall power is connected and that the unit is charging. Automatically zeros the corresponding NO or NO2 sensor. Displays “DONE!” on the LCD when zeroed. Turns on / off power, except that which is necessary to maintain the sensor in a state of readiness. Illuminates a back light for the LCD when depressed. Adjustable thumb-wheel alarm settings for high alarms (NO & NO2) and low alarms (NO). Silences audible alarms for one minute. Turning these potentiometers adjusts the digital display to calibrate the analyzer against a known reference NO and NO

gas source.

Oxygen sensor with LED display High point 100% calibration Mass flow meter with 3.5 digit LED display, range 0 - 2 LPM in 10 mL/min (0.01 LPM) increments Precision metering valve Illuminates when sample line becomes occluded

Document No. 715-7000 Revision E Page 32 of 63

Diagram # 9

1. Quick Connect Gas Inlet Female high pressure gas inlet, receives male connector on SS hose from delivery regulator

2. Sample Gas Inlet Male luer connector. Hydrophobic filter from sample line (P/N 415-0004) attaches here

3. Delivery Gas Outlet Female luer connector. Delivery line (P/N 415-0001) attaches here

CAUTION! Luer fittings are common to both the AeroNOx and to most intravenous systems. Careful attention must be paid when connecting and disconnecting luer connections to avoid inadvertent administration of NO gas into a patient I. V. system.

Quick Connect Gas Fittings

The AeroNOx was designed with quick connect gas fittings for quick and easy connection from the AeroNOx empty to a full cylinder, or when switching from a bedside to a transport cylinder and vice versa.

To connect the fittings, insert the male quick connect on the SS hose into the female quick connect located on the AeroNOx unit and on the delivery regulators and push them together until an audible “click” is heard and the two connections stay together.

Document No. 715-7000 Revision E Page 33 of 63



to the delivery gas regulators. This can be utilized either when changing from an

CAUTION! Ensure the regulator is purged prior to connection to the patient circuit. See “Purge procedures to follow when changing tanks and/or regulators” in SECTION II.

To disconnect, pull the sleeve on the female connector toward the male connector. The quick connects will release from each other with very little effort.

THE NIPPLE SEAL SHOWN IN THE PHOTO BELOW MAY LEAK IF NOT SECURELY FITTED TO THE NIPPLE.

TO ENSURE AN ADEQUATE SEAL BETWEEN THE TANK VALVE AND THE REGULATOR, HAND TIGHTEN THE NIPPLE SEAL UNTIL IT IS FULLY SEATED. DO NOT OVERTIGHTEN.

Luer Lock Connections

The sample gas inlet and the delivery gas outlet are equipped with luer connectors. These connectors are very common in the hospital environment because of the quick way that air tight connections can be made. These are the same connections found on I. V. tubing.

To attach the sample line (P/N 415-0004) to the sample gas inlet, simply fit the female luer on the hydrophobic filter on the sample line to the male luer located below and to the left of the handle on the AeroNOx and turn the hydrophobic filter in a clockwise direction until a firm connection is established. To remove, turn the hydrophobic filter in a counterclockwise direction, then gently pull the sample line free.

To attach the delivery line to the AeroNOx, fit the male end of the delivery line onto the female luer located below and to the right of the handle on the AeroNOx direction until a firm connection is established. To remove, turn the male fitting in a counterclockwise direction.

CAUTION! Do not use the AeroNOx without the “NO WORRIES” sample line (P/N 415-0004) which includes both the Nafion



tubing and the hydrophobic filter for removing condensing humidity from the sample gas. Failure to do so may impair the function of the AeroNOx as well as decrease the life of the internal components. WARRANTY MAY NOT BE HONORED FOR DAMAGE CAUSED IN THIS MANNER!



and turn in a clockwise

Document No. 715-7000 Revision E Page 34 of 63

Battery

The AeroNOx is supplied with a rechargeable 6 volt sealed lead acid battery. The unit is shipped with the battery disconnected to prevent the battery from fully discharging during shipping. To re-connect the battery, remove the battery compartment panel on the back of the AeroNOx. Connect the cable on the battery to the cable in the compartment. The expected life of the battery is approximately one (1) year. Battery life varies considerably depending on the amount of clinical use while the unit is unplugged.

The amount of charge that the battery holds is indicated by the letter “B” on the left hand side of the display. This character will appear as soon as the unit is disconnected from the power supply. As the charge that the battery holds increases, the letter “B” fills in until it resembles a solid “B”. There are six levels of charge indicated by how much of the “B” is filled in. When the power supply is connected to the AeroNOx, a character that resembles a power plug appears in place of the “B”. This character indicates that the unit is plugged in and is charging.

If “LOW BATTERY” Alarm Occurs:

 An audible alarm as well as a visual “LOW BATTERY” message will appear alternately

with the sensor data when the battery no longer carries enough charge to reliably operate the electronics. This message will remain on the screen for approximately 4 minutes, depending on the condition of the battery. If the unit remains disconnected from the power supply, the screen will begin to alternately display the messages “CONNECT CHARGER”, “DATA INVALID”, and “NITRIC OFF” until the display fades out for lack of power. GAS FLOW TO YOUR PATIENT WILL BE DISCONTINUED AT THIS TIME! Gas flow to your patient is always terminated once the unit is powered off, intentionally or non-intentionally.

Should you completely lose battery function to the AeroNOx:

 Plug in the 12 V universal power supply and allow the internal charging circuit to recharge

the battery.

 After the battery is recharged ~ 24 hours, recalibrate the sensors using the procedure in

SECTION V of this manual.

Battery Maintenance & Storage:

 The battery discharges even when the monitor is turned off. For this reason, the

AeroNOx battery discharge.

 Should the AeroNOx

plugged in, the battery should be disconnected to prevent the battery from fully discharging.

 A fully discharged battery requires ~ 30 minutes to become functional and ~ 24 hrs to fully

recharge.



should be kept plugged in whenever possible in order to prevent complete



need to be stored for periods greater than one week without being

Document No. 715-7000 Revision E Page 35 of 63

Once the battery has discharged below a certain voltage, bias to the sensors is lost. An unbiased sensor can take up to 48 hours to become functional again. Unbiased sensors will read a value greater than zero when exposed to room air. This value will continue to drop as the sensor biases. Once the value has dropped to zero, the AeroNOx must be re-calibrated prior to use.

CAUTION! Use only P/N 888-0115 as the battery source for the AeroNOx.

CAUTION! Disconnect the battery when the unit is not in use for extended periods of time or if the system must remain unplugged for extended periods of time.

CAUTION! Attempting to run the AeroNOx for longer than five hours on battery only could result in an interruption of Nitric Oxide Therapy.

Document No. 715-7000 Revision E Page 36 of 63

Universal Power Supply

The universal power supply accepts a 100 - 240 V A/C ~ 50 - 60 Hz input, and supplies a +12 V D/C @ 3.3 A max. output.

For the AeroNOx, the universal power supply is both a voltage source for the internal charging circuit and an A/C power supply. It will simultaneously power the analyzer and charge the internal battery. The internal charging circuit is self-regulating and will sense the condition of the battery, charging and not charging as required.  It is recommended that the power supply be used whenever possible, to ensure the

battery is kept fully charged.

 The analyzer is powered by the internal battery at all times. The plugging in or

unplugging of the external power supply from either end will have no effect on the analyzer operation or battery life.

CAUTION! Use only the universal power supply (P/N 293-0040) as a power supply to the AeroNOx.

Document No. 715-7000 Revision E Page 37 of 63

SECTION IV - SPECIFICATIONS

NOTE: Standard conditions referred to throughout the specifications consist of the

following:

Temperature (transport & storage) - 20 C to + 40 C Operating temperature + 5 C to + 40 C Altitude up to 3800 meters or 12,000 ft. Relative Humidity 0 - 93% non-condensing

Functional Performance

Measurement range

 0 to 100 ppm nitric oxide  0 to 12 ppm nitrogen dioxide  5 to 100 % oxygen

Meter Resolution

 1.0 ppm nitric oxide  0.1 ppm nitrogen dioxide  0.1% oxygen

Sensor Accuracy

  1 ppm nitric oxide   0.1 ppm nitrogen dioxide   2% oxygen1

Sensor Response Time

 90% response to a change in [NO] in < 20 sec.  90% response to a change in [NO2] in < 30 sec.  95% response to a change in O2 (FiO2) in < 30sec.

Sensor Stability

<2% signal loss per month

Device Accuracy

  2 ppm nitric oxide   2 ppm nitrogen dioxide   3% oxygen

At the altitude at which it is calibrated, see next page for Effect of Altitude on the AeroNOx.

Device accuracy is affected by the ventilator that is attached.

Document No. 715-7000 Revision E Page 38 of 63

Effect of Altitude on the AeroNOx

Effect of Altitude on AeroNOx Oxygen Sensor

Test Conditions: PIP: 30 cmH2O, PEEP: 5 cmH2O, Ti: 0.3 seconds, RR: 60,

Flow: 10 LPM FiO2: 1.0, NO: 20 ppm, ASCENDING

120

96.5 (0.3)

100

91.6 (0.4)

Mean (SD)

Oxygen (%)

n=5

88.3 (0.3)

76.1 (0.6)

65.7 (0.60

82.0 (0.3)

70.7 (0.6)

2200 3000 4000 6000 8000 10,000 12,000

Altitude (feet above sea level)

NO and NO2 Sensors

The AeroNOx NO and NO2 sensors are not pressure dependent and are thus unaffected by altitude changes during transport.

Oxygen Sensor



The oxygen sensor in the AeroNOx

is affected by altitude (partial pressure) changes. The above graph shows a predictable linear slope for the first 4000 feet and then a nominal change between 4000 and 12,000 feet. As altitude increases, the oxygen percentage display will decrease to reflect the change in partial pressure at the corresponding change in altitude. The following formula can be used to calculate the predicted change in oxygen percentage at a specific altitude.

NOTE

: Remember to first determine the effect of the NO delivery on the oxygen

percentage as shown in SECTION VII, Calculations and Troubleshooting.

Document No. 715-7000 Revision E Page 39 of 63

Step 1 - Calculate predicted change in oxygen percentage by multiplying the anticipated altitude reading by - 4.71  10-3. Use this factor between sea level and 4000 feet. If the flying altitude will be greater than 4000 feet above sea level, then use - 2.56  10-3 factor. For example:

If the reading on the AeroNOx is 60% at an altitude of 2000 feet above sea level, then to calculate what the oxygen will be reading at a flying altitude of 8,000 feet above sea level you would calculate as follows:

Calculated difference in Oxygen reading = (-2.56  10-3) New altitude

= (-2.56  10-3) 8,000 = -20.5%

New Oxygen reading = Current reading - Calculated difference in Oxygen reading

= 60% - 20.5% = 39.5%

Flow Meter Display

The flow meter display will be affected nominally with a change in the altitude. However, the delivered and displayed NO will not change. The average change with flow meter displayed for

0.56 LPM at 2000 feet above sea level read 0.53 (SD=0.02) at 12,000 feet above sea level.

Alarms

 Manually adjusted thumb wheel switches with 1 ppm resolution  NO: Low adjustable from 0 - 99, high adjustable from 0 - 99. Audible and visual alarm

when actual value is at set alarm value

 NO2: High audible and visual alarm when actual value is at set alarm value. Factory

default setting for high NO2 alarm is 11 ppm when thumb wheels are adjusted to 11 ppm or higher (thumb wheels adjustable to 99 ppm).

 Depressing the alarm silence button will deactivate the audible alarm, but not the visual

alarm, for one minute. If the alarm condition corrects itself, the audible and visual alarm will deactivate. If the actual NO/NO2 value reenters the alarm condition, the audible and visual alarms will be activated, even if one minute has not elapsed since the alarm silence button was pushed.

Sample Gas Flow

 150 cc/min  15%  sampled gas is vented to the room through a vent located on the right-hand side of the



AeroNOx

Sample Inlet Pressure

 Cyclic pressure up to 80 cmH2O (Ti = 3.0 sec. and 6.6 cycles per minute)

Expected Life of Life-Limited Components under conditions of typical clinical usage:

 NO Sensor ...................................min. 2000 hours

 NO2 Sensor ..................................min. 2000 hours

 Oxygen Cell .................................min. 2000 hours

 Sample Pump...............................min. 2000 hours

Document No. 715-7000 Revision E Page 40 of 63

Physical Specifications

25.4  30.5  12.7 cm

Dimensions (H  W  D)

10  12  5 inches Weight (AeroNOx only) NO Flow Meter:

Range Display Resolution Accuracy (Including Linearity)

~ 11 lb. (~ 4.8 kg.)

0 - 2 LPM

10 cc

 5% F. S. Precision Metering Valve ~ 12 turns to fully open Gas Supply Recommend NO @ 800 ppm N2 Gas Fittings CGA 626, Quick Connect & Luer

Power Supply

Battery Life

Internal 6 V sealed lead acid battery

charged by Universal power supply

Fully charged will last at least 5 hours

Battery life ~ 1 year

Safety

 EMC: Compliance with EN60601-1-2  Flammable anesthetics: Not for use in the presence of flammable anesthetics  Regulatory Approvals: CSA, ETL, CE  Specifications are subject to change without notice.

Document No. 715-7000 Revision E Page 41 of 63

SECTION V - CALIBRATION

Calibration of the AeroNOx NO / NO2 / O2 Analyzer

The AeroNOx must be used with calibration gas and accessories specified by the manufacturer.

Diagram # 10 AeroNOx Calibration Circuit (P/N 415-0000)

Document No. 715-7000 Revision E Page 42 of 63

AeroNOx Calibration Procedure:

1. Turn Power on.

2. Use only the calibration circuit supplied, P/N 415-0000. Failure to use the supplied

calibration circuit may result in damage to the AeroNOx or inaccurate calibration results.

OXYGEN SENSOR CALIBRATION

3. Connect the nipple end of the calibration circuit to oxygen tubing.

4. Run wall O

5. Connect the luer connector of the calibration circuit to the sample inlet of the AeroNOx.

6. Allow the O2 reading to stabilize for 2 - 4 minutes. Calibrate oxygen sensor @ 100% by

adjusting the calibration potentiometer using the calibration screwdriver (P/N 416-0010) provided. ** When using the oxygen analyzer to analyze oxygen concentrations

below 30%, the oxygen analyzer should be re-calibrated to 21% oxygen to improve the accuracy in the lower range.

The NO and NO2 cells can be zeroed in oxygen or in room air. You may choose to leave the oxygen running during the zero procedure.

7. NO Zero Procedure: Zero the NO sensor by depressing and holding the NO zero button down. The words ZERO NO appear on the screen. The sensor is zeroed when the word DONE! appears.

8. NO2 Zero Procedure: Zero the NO2 sensor by depressing and holding the NO2 zero button down. The words ZERO NO2 appear on the screen. The sensor is zeroed when the word DONE! appears.

9. Disconnect calibration circuit from the AeroNOx.

10. Disconnect the O2 and attach NO2 calibration gas to the calibration circuit.

11. Turn on the calibration gas flow by opening the valve located on the calibration gas cylinder. The calibration regulators (P/N 731-9141) are factory set to deliver 0.5 LPM. If you are not using these regulators, be sure to adjust the calibration gas flow to 0.5 LPM.

12. Connect calibration circuit to the AeroNOx

13. Allow the NO2 reading to stabilize for 2 - 4 minutes, or until the reading has not changed for at least 30 seconds. Adjust the NO2 potentiometer on the front panel with the calibration screwdriver (clockwise to increase, counterclockwise to decrease) until the display matches the chemist’s reported “ACTUAL” NO

14. Disconnect the NO LPM (or allow room air to be drawn in to the analysis sample inlet) until both sensors read zero.

through the cal. circuit @ 0.5 LPM.

ZERO BOTH NO & NO2 SENSORS

CALIBRATE NO2 SENSOR



as in Step 5.

PURGE NO / NO2 SENSORS

calibration gas, and run oxygen through the calibration circuit @ 0.5

reading on the gas cylinder label.

Document No. 715-7000 Revision E Page 43 of 63

CALIBRATE NO SENSOR

15. Disconnect calibration circuit from the AeroNOx.

16. Disconnect the O2 and attach NO calibration gas to the calibration circuit.

17. Turn on the calibration gas flow by opening the valve located on the calibration gas cylinder. The calibration regulators (P/N 731-9141) are factory set to deliver 0.5 LPM. If you are not using these regulators, be sure to adjust the calibration gas flow to 0.5 LPM.

18. Connect calibration circuit to the AeroNOx as in Step 5.

19. Allow the NO reading to stabilize for 2 - 4 minutes, or until the reading has not changed for at least 30 seconds. Adjust the NO potentiometer on the front panel with the calibration screwdriver (clockwise to increase, counterclockwise to decrease) until the display matches the chemist’s reported “ACTUAL” NO reading on the gas cylinder label.

20. Disconnect the calibration circuit and allow room air to be sampled into the AeroNOx until the NO and NO2 displays return to zero and the Oxygen sensor reads 21%. This is to flush out any calibration gas remaining in the AeroNOx sampling circuit after calibration. This step will help ensure the longevity of the AeroNOx sensors.

READY TO GO

The AeroNOx is calibrated and ready for use.

Important Reminders

1. The AeroNOx has been designed and tested for use with calibration gases specified by the manufacturer. International Biomedical can not guarantee the accuracy of the AeroNOx when calibration gases other than specified gases are used.

2. Use only the calibration circuit provided to avoid damage to the AeroNOx or inaccurate calibration results.

3. Zero NO & NO2 sensors daily & calibrate weekly when in use.

4. The AeroNOx holds its calibration even when the unit has been powered off. This allows for the unit to be calibrated and then stored until it is needed. There is no need to recalibrate the AeroNOx unless a period of one week or greater has elapsed since the last calibration.

Helpful Hint:



It is a good practice to calibrate the AeroNOx

weekly even when not in

use. This ensures that the AeroNOx is always ready for use.

Document No. 715-7000 Revision E Page 44 of 63

SECTION VI - NITRIC OXIDE DELIVERY

The AeroNOx Nitric Oxide Titration & Monitoring System was designed to deliver a continuous flow of NO gas into the patient’s bulk gas flow.

Inspiratory Limb NO Titration in Constant Flow Ventilators or Other Respiratory Gas

Administration Systems

This technique is modeled after the system tested by Betit and colleagues published in Respiratory Care July 1995 Vol 40 No. 7 p 706-715. With constant flow ventilators, stability of the [NO] is assured because both the NO gas and the gas flow from the ventilator are fixed (constant).

Precautions for Inspiratory Limb NO Titration

1. Carefully select “tight” NO & NO2 alarms on the NO / NO2 analyzer.

2. Where applicable, ensure that the minute ventilation supplied by the ventilator or by other respiratory gas administration systems is consistent. Carefully select “tight” minute volume alarms. This is critical.

3. Titrate the desired NO dose before you attach the system to the patient, using a test lung with both the ventilator & NO delivery system running for approximately 1 minute prior to patient connection.

4. Ensure that the dose measured by the AeroNOx is the actual desired nitric oxide concentration and that NO2 values are acceptable. For acceptable limits, see the “NO2 in ppm” table in SECTION VII.

Ventilators Safe for Use with the AeroNOx

In general, any ventilator which functions as a true continuous flow ventilator may be used with the AeroNOx. Some ventilators have modes labeled “continuous flow” but may not function as true continuous flow ventilators. Please consult the manufacturer of the ventilator you intend to use with the AeroNOx to determine if, and in what modes, your ventilator will operate as a continuous flow ventilator.

CAUTION! The AeroNOx only! Check with your ventilator manufacturer to determine the flow characteristics of the ventilator you wish to use.

The following ventilators have been tested for use with the AeroNOx:

1. Sechrist 100IVB in all modes

2. Bird VIP in conjunction with the Infant Flow Sensor in the following time cycled modes: a) Assist Control b) SIMV c) CPAP

3. Infant Star 100 Neonatal Ventilator

4. SensorMedics 3100A & 3100B

5. BioMed Devices MVP-10 Ventilator

6. BioMed Devices CV2i Ventilator

7. Percussionaire Bronchotron Ventilator



is designed to be used with continuous flow ventilators

Document No. 715-7000 Revision E Page 45 of 63

(

)

Nitric Oxide Concentration Profiles

The following graph represents the concentrations of nitric oxide representative of the delivered concentration to the patient throughout the respiratory cycle when using the INOstat Bagger.

INOstat™ Manual Bag Resuscitator

(Target 20 ppm)

Rate = 10 -150+ bpm PIP/PEEP = 20/4; Mean = 20.13 ppm; SD=0.29

25 20

NO (ppm)

Pressure

NO (ppm) &

Pressure (cmH

(cmH2O)

0 20406080

Time (s)

The graph below represents the concentration of nitric oxide representative of the delivered concentration to the patient during mechanical ventilation with each ventilator tested for use with the AeroNOx.

Nitric Oxide Concentration

Ventilator Pressure

Concentration

Nitric Oxide

Document No. 715-7000 Revision E Page 46 of 63

NO = 20  1 ppm

Ventilator Pressure

PIP/PEEP = 24/4 cmH2O

Time

SECTION VII - CALCULATIONS & TROUBLESHOOTING

1. CALCULATIONS FOR NITRIC OXIDE DELIVERY

 Where to start?

How to estimate initial NO flow

 What is the diluted FiO

Estimating your FiO

after dilution with NO gas

 How are we doing?

Oxygen Index Calculation

2. CYLINDER DURATION NOMOGRAMS

 How long will this tank last?

3. AERONOX TROUBLESHOOTING GUIDE

 When all else fails, read the manual...

CALCULATIONS FOR NITRIC OXIDE DELIVERY

Where to start?

 It is imperative that you determine what NO flow to set, and what the NO flow reading

should be during NO administration for the desired dose.

 To determine the initial Nitric Oxide (NO) flow rate, given your NO source gas

concentration, [NO], ventilator minute ventilation & desired NO dose, use the formula below.

 To determine NO flow for use with the AeroNOx Bagger or other respiratory gas

administration systems, substitute O

Initial NO Flow (LPM) =

Example:

 Minute volume, or ventilator flow = 10 LPM.  Nitric oxide source tank = 800 ppm  You want to deliver 25 ppm to your patient.

Initial NO Flow (LPM) =

10 LPM  25 ppm Desired [NO]

800 ppm Tank [NO]

flow for ventilator flow in the equation below.

Vent Flow (LPM)  Desired [NO] ppm

Source Tank [NO] ppm

250

800

= 0.31 LPM

Document No. 715-7000 Revision E Page 47 of 63

 Set 800 ppm NO source gas flow @ 0.31 LPM to get ~ 25 ppm NO diluted in 10 LPM

fresh gas flow.

The chart below was developed using the previous calculations. You may use it as a starting point for setting your NO flow rate. Please note that these are reference points only. The

actual dose delivered must be measured by the analysis portion of the AeroNOx.

Minute Volume / Ventilator / Bagger Flow

[NO] 5 10 15 20

5 ppm 10 ppm 20 ppm 40 ppm 80 ppm

0.03 0.06 0.09 0.13

0.06 0.13 0.19 0.25

0.13 0.25 0.38 0.50

0.25 0.50 0.75 1.00

0.50 1.00 1.50 2.00

NO Flow in LPM

The following table represents the average NO2 value measured at an FiO2 of 1.0 during testing with the ventilators listed in this manual. Use it as a reference for what NO

values you can

expect when delivering the NO concentrations listed in the column on the left.

Minute Volume / Ventilator Flow

[NO] 5 10 15 20

5 ppm 10 ppm 20 ppm 40 ppm 80 ppm

0.5 0.1 0.1 0.1

0.5 0.2 0.2 0.1

0.5 0.3 0.2 0.2

0.8 0.6 0.4 0.4

2.0 1.5 1.2 1.1

NO2 in ppm

The tables above are for reference only. Factors such as the accuracy of the ventilator flow, percent error in delivery apparatus, and human error, may all affect the actual delivered patient dose. The calculated NO flow should be compared with the analyzed NO dose to confirm accurate NO dosing. Should the actual NO flow differ from the calculated NO flow by more than 10% beyond published specifications, the cause must be determined and corrected immediately. If the cause can not be immediately determined, ensure patient safety and contact International Biomedical at 1-800-433-5615 for further assistance.

CAUTION! NO flow must be continually evaluated during Nitric Oxide administration to ensure accurate dosing!

Document No. 715-7000 Revision E Page 48 of 63

What is the diluted FiO2?

Estimating your FiO2 after dilution with NO gas, given your NO flow setting, and total ventilator gas flow

Estimated FiO2 =

Initial FiO2 - (NO Flow / Total Flow O2 + Total NO Flow)  100

Example:

 Initial FiO2 = 1.0 (100%)  NO flow = 0.31 LPM (800 ppm gas, bal Nitrogen)  Ventilator flow = 10 LPM  Total flow = 10.31 LPM

Estimated FiO2 = 1 - (0.31 / 10.31 LPM) = 0.97

Estimated % O2 = 1 - (0.31 / 10.31 LPM)  100 = 97%

 When delivering ~ 25 ppm NO (~ 0.31 LPM) in ~ 10 LPM of 100% oxygen, you can

expect the % O2 to be diluted by ~ 3%.

 In this case, the maximum FiO2 you can expect is ~ 0.97.

How are we doing?

Oxygen Index Calculation:

Oxygen Index (OI) = Paw  FiO2  100 / PaO2, (mmHg)

Interpretation: Most centers interpret less than 15 as good.

 Mean airway pressure in cmH  Fraction of inspired oxygen = FiO  Arterial oxygen tension in mmHg = PaO2

Example: Pre Nitric Oxide Data

 FiO2 = 1.0 (100%)  PaO2 = 65 mmHg  Paw (Mean Airway Pressure) = 15 cmH

Oxygen Index (OI) = 15  1  100 / 65 = 23

O = Paw

Document No. 715-7000 Revision E Page 49 of 63

Post Nitric Oxide Data

 FiO2 = 0.55 (55%)  PaO2 = 75 mmHg  Paw = 12 mmHg

Oxygen Index (OI) = 12  0.55  100 / 75 = 8.8

In this example, OI improved markedly (23 to 8.8) after inhaled nitric oxide administration.

Document No. 715-7000 Revision E Page 50 of 63

Calculation of Cylinder Duration

How long will this tank last?

 The volume of gas in your cylinder(s) is a function of the filling pressure and the capacity

(size) of the cylinder. For compressed gases, this relationship is linear and can be expressed as a tank factor which is equal to cylinder volume / pressure expressed in LPM.

GAS SUPPLY

E. g. Large NO Cylinders

 Capacity (L): 2040  Maximum Pressure (full): 2000 psig

Tank Factor =

The amount of therapeutic gas remaining in a cylinder can be estimated in minutes or hours, provided that three things are known:

1. Tank Factor

2. Tank Pressure

3. Flow Rate

Cylinder Duration (Minutes) =

The two following nomograms can be used to estimate cylinder duration.

CYLINDER DURATION Below you will find an example of how to determine cylinder duration based on the following:

 Rounded down to the nearest quarter hour  Based on set flow rate and tank pressure  Time listed is time to run the cylinder dry (cylinders should be

changed out at 250 psig)

E. g. #1 - Cylinder Duration for a Cylinder with 2040 L @ 2000 psig

 Tank Factor = 2040 L Cylinder @ 2000 psig = 1.02 L/psig

2040 L

2000 psig

= 1.02 L/psig

Cylinder Pressure (psig)  Factor (L/psig)

Flow Rate (LPM)

Document No. 715-7000 Revision E Page 51 of 63

Flow Rate (LPM)

Pressure .125 .25 .5 .75 1.0 1.5

2000 1500 1000

500 250

272 136 68 45.25 34 22.5 204 102 51 34 25.5 17 136 69 34 22.5 17 11.25

68 34 17 11.25 8.5 5.5 34 17 8.5 5.5 4.25 2.75

Time in Hours

How much calibration gas do I need?

Calibration gas regulators have a preset flow of 0.5 LPM. Since sensor stabilization usually takes ~ 2 - 4 minutes, one sensor calibration should take ~ 2 - 4 minutes and use ~ 2 L of calibration gas.

Document No. 715-7000 Revision E Page 52 of 63

AERONOX TROUBLESHOOTING GUIDE

FRONT PANEL - OPERATIONAL MESSAGES

Alarm Silence NO Alarm Silence NO2

ZERO NO

ZERO NO2

ZERO NO & ZERO NO PRESSED TOGETHER

Visual LED

BUTTON

PRESSED

Silences audible alarm for 1 minute Silences audible alarm for 1 minute Sets calibration baseline for selected sensor Sets calibration baseline for selected sensor

Displays the total time in hours that both sensors have been in service

Alerts user that the sample line has become obstructed

PURPOSE MESSAGE

ALARM SILENCE

Visual alarm persists until rectified

ALARM SILENCE

Visual alarm persists until rectified

CAL NO, after 5 seconds, DONE!

CAL NO2, after 5 seconds, DONE!

SENSOR TIME

, after 5 seconds, time in hours that both sensors have been in service

SAMPLE OBSTRUCTION

Document No. 715-7000 Revision E Page 53 of 63

ERROR / WARNING MESSAGES

MESSAGE DESCRIPTION ACTION

“LOW

BATTERY”

alternating

with sensor

data

“NO ZERO

FAILURE”

“NO2 ZERO

FAILURE”

“ROM

FAILURE”

“CHECK

SAMPLE

LINE”

Battery voltage < minimum operating voltage

Zero baseline calibration has been corrupted. Zero baseline calibration has been corrupted. Data stored in read only memory has been corrupted or damaged.

Sample line has become occluded, pump may have shut down.

Try to recharge the battery as outlined in SECTION III, Battery. If the battery still does not function, either the charger or battery must be inspected by a biomedical engineer. Power unit off and then back on. Calibrate as per SECTION V. Power unit off and then back on. Calibrate as per SECTION V. Return to International Biomedical for repair. Check sample line for occlusion. Remove occlusion. Power unit off for 3 - 5 seconds, then power back on. This will re-set pump flow. To re-enable the “safety” shut-off,

“SAFETY

OFF”

alternately

displayed with

sensor data

“Safety” shut-off system has been disabled.

a) simultaneously depress the NO and NO2 alarm silence buttons for 5 seconds until the display reads “SAFETY ON” or b) power the unit off, then back on again.

NO gas flow to your patient has

Manually ventilate your patient with a bagger capable of delivering a safe and known concentration of NO gas to the patient. Determine the cause of the alarm. Do not resume NO administration with the AeroNOx until it is safe to do so.

“NITRIC OFF”

alternately

displayed with

sensor data

been discontinued because NO analysis indicated NO delivery levels in excess of 5 ppm above the set “Hi” alarm limit or 100 ppm whichever is the less value or NO2 levels 1 ppm above the set “Hi” alarm limit or 12 ppm whichever is the less value.

“DATA

INVALID”

alternately

displayed with

“CONNECT

The battery voltage has dropped below a point where data can be accurately displayed.

Connect the AeroNOx supply and plug into a wall outlet.

CHARGER”



to the power

Document No. 715-7000 Revision E Page 54 of 63

COMMON PROBLEMS ENCOUNTERED

SYMPTOM CAUSE ACTION

1. Possible system leaks

Sensors are slow to calibrate or will not calibrate

NO / NO2 values drift during calibration, will not hold cal. values

NO / NO2 values drift during clinical use

Screen remains blank when unit is powered up. Pump will not run when unit is powered on.

“AERONOX” is displayed even when the unit is powered off

CAUTION! Disconnect the battery when the unit is not in use for extended periods of time or if the system must remain unplugged for extended periods of time.

2. Sensors may need replacing. Please refer to the section on Sensors for sensor life.

3. Calibration gas may have expired.

1. Sensors may need replacing. Please refer to the section on Sensors for sensor life.

2. Sensors may need additional time to be biased

1. Sensors may need replacing. Please refer to the section on Sensors for sensor life.

2. Sensors may need additional time to be biased.

3. Incomplete gas mixing in your patient circuit may be occurring.

1. Internal battery has become discharged.

2. Internal battery requires replacement.

1. Battery is not fully charged.

2. Internal battery requires replacement.

1. Ensure O oxygen during O during NO or NO If not, check for external leaks. Send to Biomedical engineering for internal system leak check.

2. Have Biomedical engineering change sensors.

3. Check “Analysis date” on cal. gas label.

1. Have Biomedical Engineering replace sensor(s).

2. Allow 24 - 48 hours for sensors to bias. Calibrate as per SECTION V.

1. Have Biomedical Engineering replace sensor(s).

2. Allow 24 - 48 hours for sensors to bias. Calibrate as per SECTION V.

3. Refer to SECTION VI, Nitric Oxide Delivery Techniques.

1. Plug “Universal Power Supply” into the AeroNOx for at least 30 min.

2. Have Biomedical Engineering replace the battery.

1. Plug “Universal Power Supply” into the AeroNOx for at least 30 min.

2. Have Biomedical Engineering replace the battery.

analyzer reads 100%

sampling and 0%

cal. gas sampling.



and allow to charge



and allow to charge

Document No. 715-7000 Revision E Page 55 of 63

SYMPTOM CAUSE ACTION

NO screen displays “1600” and/or NO

screen

displays “21”

NO2 screen displays 21 and will not change

Either or both screens display a (-) hash mark

NO / NO2 values drop suddenly after water has entered the AeroNOx



sampling block

NO sensor will not return to zero

1. Bias voltage to the sensors has been lost.

1. NO

sensor has been

exposed to NO

values in

excess of 21 ppm.

1. Sensors have drifted below zero.

1. Water is preventing the sampling gas from reaching the sensor membrane.

1. Sensor has been exposed to high levels of NO (>100 ppm).

1. Recharge or replace battery and allow 24 - 48 hours for the sensors to re-bias.

1. Allow room air or oxygen to be aspirated into the AeroNOx sampling block until NO returns to zero. Calibrate the NO



value

channel. Exposure to high levels of NO

will decrease the sensor’s life.

1. Zero sensors as outlined in the calibration procedure (SECTION V).

1. Run room air or oxygen through the AeroNOx



to dry out the sampling

chamber. Calibrate the analyzer as in SECTION V prior to putting the AeroNOx



back into clinical use.

Use sample line P/N 415-0004 to prevent water from entering the AeroNOx



1. Run room air or oxygen through the analysis port until the value returns to zero. The length of time this will take will depend on how much NO the sensor was exposed to and for how long. Exposing the sensors to high levels of NO will decrease the sensor’s life.

Document No. 715-7000 Revision E Page 56 of 63

SECTION VIII - CLEANING & MAINTENANCE

CLEANING

1. Clean the AeroNOx cable assembly surfaces by wiping them with a cloth moistened with a mild detergent or bactericidal agent. Avoid using alcohol on the liquid crystal display.

Caution!  DO NOT sterilize the AeroNOx

sterilization techniques.

 DO NOT clean any parts with acetone or other strong solvents.  DO NOT immerse or allow water or any other liquid to enter the

AeroNOx

REPAIRS AND REPLACEMENT

All routine maintenance, repairs, and replacement of standard parts should be conducted according to procedures outlined in the Technical manual. For all clinical or technical issues not addressed in the manual, please contact International Biomedical directly at:

CUSTOMER SERVICE

Should you need clinical or technical information, please feel free to contact International Biomedical. To help us to help you, please have the following information available:

 A complete description of the problem / observation  Model #  Serial #  Your Institution address  Your fax #

The above information is necessary to determine warranty status as well as to gather the information necessary for us to fill out a Return Merchandise Authorization (RMA) should you need to send anything back for repair. Any equipment sent to International Biomedical without an RMA will not be accepted for delivery. Do not ship any products to International Biomedical without first obtaining an RMA.



system with mild detergent. Clean the AeroNOx analyzer and



analyzer by steam autoclave or gas



analyzer or housing.

In North America, Call Toll Free: 1-800-433-5615 Internationally, Call 1-512-873-0033 FAX: 512-873-9090

Document No. 715-7000 Revision E Page 57 of 63

INSTRUCTIONS FOR DISPOSAL

To dispose of the AeroNOx:

1. Remove the battery and dispose of it in accordance with local regulations, or recycle it by calling the toll free number listed on the battery.

2. The remainder of the AeroNOx can be disposed of as per your hospital’s policy for nonhazardous materials, or it may be returned to International Biomedical for disposal.

Document No. 715-7000 Revision E Page 58 of 63

SECTION IX - WARRANTY

Subject to the exceptions* and upon the conditions* stated below, International Biomedical warrants that the products sold under this sales order shall be free from defects in workmanship and materials for one year after delivery of the products to the original Buyer by International Biomedical, and if any such products should prove to be defective within such one year period International Biomedical agrees, at its option, (i) to correct by repair or at International Biomedical’s election, by replacement with equivalent product any such defective product, provided that investigation and factory inspection discloses that such defect developed under normal and proper use (ii) to refund the purchase price.

The exceptions* and conditions* mentioned above are as follows:

a) Exchange, and/or factory repaired components are warranted for ninety (90) days from

ship date, from factory.

b) Upgraded parts are warranted for 6 (six) months from ship date from factory.

c) Electrochemical sensors are warranted for 6 (six) months from ship date to the original

buyer.

d) Components or accessories manufactured by International Biomedical which by their

nature are not intended to and will not function for one year are warranted only to give reasonable service: what constitutes reasonable shall be determined solely by International Biomedical. A complete list of such components and accessories is maintained at the factory.

e) International Biomedical makes no warranty with respect to components or accessories

not manufactured by it in the event of defect in any such component or accessory. International Biomedical will give reasonable assistance to the Buyer in obtaining from the respective manufacturer whatever adjustment is authorized by the manufacturer’s own warranty.

f) Any International Biomedical product claimed to be defective must, if required by

International Biomedical, be returned to the factory, transportation charges prepaid, and will be returned to Buyer with transportation charges collect unless the product is found to be defective due to workmanship or materials, in which case International Biomedical will pay all transportation charges, subject to receipt of original shipping invoices. The customer will be responsible for duty, taxes, border charges, or claims resulting from but not limited to the improper processing of customs documents. Any damage incurred during transit from the Buyer to International Biomedical due to poor or insufficient packaging will be the responsibility of the Buyer.

g) If the product is a disposable or the like, it is warranted only to conform to the quantity

and content and for the period stated on the label at the time of delivery.

h) International Biomedical may from time to time provide a special printed warranty with

respect to a certain product, and where applicable, such warranty shall be deemed incorporated herein by reference.

Document No. 715-7000 Revision E Page 59 of 63

i) International Biomedical shall be released from all obligations under all warranties, either

expressed or implied, if any product covered hereby is repaired or modified by persons other than its own authorized service personnel unless such repair by others is made with the written consent of International Biomedical.

IT IS EXPRESSLY AGREED THAT THE ABOVE WARRANTY SHALL BE IN LIEU OF ALL WARRANTIES OF FITNESS AND OF THE WARRANTY OF MERCHANTABILITY AND THAT INTERNATIONAL BIOMEDICAL SHALL HAVE NO LIABILITY FOR SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND OR FORM ANY CAUSE WHATSOEVER ARISING OUT OF THE MANUFACTURE, USE, INABILITY TO USE, SALE, HANDLING, REPAIR, MAINTENANCE, OR REPLACEMENT OF ANY OF THE PRODUCTS SOLD UNDER THIS SALES ORDER.

Representations and warranties made by any person, including dealers and representatives of International Biomedical, which are inconsistent or in conflict with the terms of this warranty, shall not be binding upon International Biomedical unless reduced to writing and approved by an expressly authorized officer of International Biomedical.

International Biomedical

8508 Cross Park Drive

Austin, Texas 78754

USA

Telephone: 1-512-873-0033

FAX: 1-512-873-9090

Toll Free: 1-800-433-5615

E-Mail: sales@int-bio.com

Website: int-bio.com

Document No. 715-7000 Revision E Page 60 of 63

SECTION X - COMPETENCY BASED PERFORMANCE CHECK-OFF TOOL

Introduction

In order to ensure patient safety, safe operation of clinical equipment is a necessity. Each employer is encouraged to have documented proof of employee competency in the operation of clinical equipment. For this purpose, International Biomedical has made available this competency based performance check-off.

This clinical check-off is based on criterion-referenced performance. Employee performance is measured against pre-established standards of behavior. These behaviors are called critical elements. Critical elements are single, discrete, observable behaviors that are mandatory for meeting the standards of acceptability. Since competency in equipment operations is required, all critical elements must be performed as specified in order to pass. 100% accuracy is recommended for completion of the clinical performance check-off.

Employees are strongly encouraged to review the Operating manual for the AeroNOx Nitric Oxide Titration & Monitoring System in order to familiarize themselves with the equipment functions, and to practice performing these functions independently as per the competency based check-off prior to the actual check-off by a clinician. During the actual check-off, the clinician is to merely observe the employee perform the required functions as per the check-off without offering assistance. As each function is performed, and if the criterion for performing the specified critical element is met, the clinician can tick off that item in the “criterion met” column. It may be necessary to provide teaching sessions or supervised practice sessions to staff prior to the clinical competency based check-off.

The following two competency based check-off tools are designed for:

1) Routine (Weekly) AeroNOx Calibration

2) AeroNOx bedside or portable NO titration & analysis with a portable ventilator.

Document No. 715-7000 Revision E Page 61 of 63

AeroNOx



1) Routine (Weekly) AeroNOx

Calibration

COMPETENCY BASED PERFORMANCE CHECK-OFF #1 of 2

Employee Name: Date of Check-Off: Supervised by:

1. Turn Power on. Use only the calibration circuit supplied (P/N 415-0000).

2. Connect the barbed fitting to standard oxygen tubing.

3. Run wall O2 through the cal. circuit @ 0.5 LPM.

4. Connect the luer connector of the calibration circuit to the sample inlet of the AeroNOx.

5. Allow the O2 reading to stabilize for 2 - 4 minutes. Calibrate oxygen sensor @ 100% by using the

calibration screwdriver to adjust the calibration potentiometer.

ZERO BOTH NO & NO2 SENSORS

6. Zero the NO sensor by depressing and holding the NO zero button down. ZERO NO appears on the

screen. The sensor is zeroed when the word DONE! appears.

7. Zero the NO2 sensor by depressing and holding the NO2 zero button down. ZERO NO2 appears on

the screen. The sensor is zeroed when the word DONE! Appears.

CALIBRATE NO2 SENSOR

8. Disconnect calibration circuit from the AeroNOx.

9. Disconnect the O2 and attach NO2 calibration gas to the calibration circuit.

10. Connect the calibration circuit to the AeroNOx as in Step 4.

11. Run the NO2 cal. gas @ 0.5 LPM. Re-attach calibration circuit as in Step 5. Allow the NO2 reading

to stabilize for 2 - 4 minutes. Adjust the NO screwdriver until the reading matches the chemist’s reported NO calibration gas tank.

PURGE NO / NO2 SENSORS Check

12. Disconnect the NO2 calibration gas, and run oxygen through the calibration circuit @ 0.5 LPM until

both sensors read zero.

CALIBRATE NO SENSOR

13. Disconnect the calibration circuit from the AeroNOx.

14. Disconnect the O2 and attach NO calibration gas, run the NO cal gas @ 0.5 LPM. Re-attach the

calibration circuit as in Step 4. Allow the NO reading to stabilize for 2 - 4 minutes. Adjust the NO potentiometer on the front panel with the calibration screwdriver until the reading matches the chemist’s reported NO concentration on the NO calibration gas tank.

15. Disconnect the calibration circuit and allow room air to be sampled into the AeroNOx until the NO

and NO gas remaining in the AeroNOx longevity of the AeroNOx

The AeroNOx is calibrated and ready for use.

displays return to zero and the Oxygen sensor reads 21%. This will flush out any calibration



sampling circuit after calibration. This step will help ensure the



sensors.

potentiometer on the front panel with the calibration

READY TO GO

concentration on the NO2

NAME: , employee # has successfully completed the AeroNOx Calibration competency.

Date: Signature:

Check

Done

Document No. 715-7000 Revision E Page 62 of 63

2) AeroNOx Portable & Bedside Set-Up

COMPETENCY BASED PERFORMANCE CHECK-OFF #2 of 2

Employee Name: Date of Check-Off: Supervised by:

CRITICAL ELEMENTS Check

1. Completed Calibration check off

2. AeroNOx SET-UP: TRANSPORT or BEDSIDE

Attach regulators to 800 ppm NO tanks

3. SOURCE GAS:

Attach high pressure quick connect from regulator(s) to AeroNOx

4. DELIVERY:

Attach delivery tubing (P/N 415-0001) from AeroNOx the sampling site.

5. SAMPLING:

Attach AeroNOx connection.

6. Double check [NO] of the cylinder & record = ppm

7. Double check NO tank pressure = psig

8. Calculate initial NO flow to achieve the desired [NO] (see SECTION V).

9. Ventilator flow / gas flow = LPM

10. Tank [NO] =

11. Desired [NO] = ppm

12. Calculated Initial NO flow =

13. Calculate maximal FiO2 (see SECTION VII).

Maximum FiO

14. Perform flush procedure.

15. Set NO flow @ the initial flow rate you calculated (# 12).

16. After readings stabilize, record the following from the AeroNOx

 Record [NO]  Record [NO  Record % O

17. Calculate the cylinder NO duration in hours & minutes (see SECTION VII).

This will last



luer sample line from AeroNOx to inspiratory limb / bagger near patient

ppm

LPM

ppm

] ppm

ppm

L tank of NO gas @ psig

Hrs Min @ LPM.



to pt. circuit at least 30 - 40 cm upstream from



NAME:

, employee # has successfully

completed the AeroNOx Portable & Bedside Set-Up competency.

Date: Signature:

Document No. 715-7000 Revision E Page 63 of 63

International Biomedical AeroNOx Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual