INOmaxDS IR Pocket Guide Rev 02 Sept 2012

IMPORTANT: This guide is provided as a convenience and for general information only. Do not use this product without clearly and thoroughly understanding the most recent revision of the INOmax DSIR® Operation Manual. The Operation Manual is the source for specific, updated information regarding warnings, cautions, checklists, diagrams, and/or instructions contained in this guide.

Overview

INOmax DSIR The INOmax DSIR has an interface using infrared (IR) technology which will allow the INOmax DSIR to communicate with the INOmeter® (which is mounted to each INOMAX® cylinder). The INOmax DSIR cart (PN 10018) has a cover with an infrared transceiver mounted directly above each INOMAX cylinder. When INOMAX cylinders are loaded, communication will take place between the INOmax DSIR and the INOmeter after the boot up phase of the INOmax DSIR is complete. A cylinder icon will be displayed on the main screen when an INOMAX cylinder is recognized by the INOmax DSIR.

INOmax DSIR Transport Regulator/Cap Assembly This assembly is used during medical transport to provide pressurized INOMAX to the INOmax DSIR as well as communicate INOMAX use information via Infrared transceivers between the INOmax DSIR (PN 10007) and the INOmeter. The transport cap assembly provides Infrared technology molded in the cap. This allows the INOmax DSIR to communicate via Infrared with the INOmeter, which is mounted to each INOMAX cylinder.

Part No. 20131 Rev-02 2012-09

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Definitions INOmeter - The factory installed INOmeter is designed for use with INOMAX cylinders only. This time-metric device records the amount of time the cylinder valve is opened. iButton – Raised silver data port on the side of the INOmeter.

Symbols Infrared Input/Output

©2012 Ikaria, Inc. INOMAX®, INOmax DSIR®, INOblender®, INOcal®, INOmeter® and INOvent® are registered trademarks of INO Therapeutics LLC.

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Part No. 20131 Rev-02 2012-09

Contents Pre-Use Checkout...5 Backup INOMAX Delivery...12 Transport Regulator/Cap Assembly...14 Oxygen Dilution Chart...18 INOMAX Cylinder 88-size Duration Chart...19 INOMAX Cylinder D-size Duration Chart...20 Connection to Various Breathing Systems...22 A-Plus Medical Babi-Plus Bubble CPAP... 23 Bagging Systems While Using the Injector Module...24 Bunnell Life Pulse High Frequency Ventilator Circuit...28 Connecting INOmax DSIR Sample Tee to the Bunnell Life Pulse Circuit...30 Connecting INOmax DSIR Injector Module to the Bunnell Life Pulse Circuit...30 Circle Anesthesia System...31 Fisher & Paykel Healthcare Bubble CPAP...32 Fisher & Paykel Healthcare Infant Circuit Nasal Cannula...33 Fisher & Paykel Healthcare Optiflow Breathing Circuit...34 Hamilton Arabella Nasal CPAP...35 ICU Ventilator Circuit...36 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit...37 .. Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit...38 Spontaneous Breathing Patient on a Mask Circuit...39 Spontaneous Breathing Patient on a Nasal Cannula...40 Teleflex Medical Comfort Flo Humidification System...41 Transport Ventilator Circuit...42 Vapotherm 2000i...46 Vapotherm Precision Flow...47 Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System... 48 Viasys Infant Flow SiPAP...49 INOblender Circuit Connection...50 Fisher & Paykel Healthcare Neopuff Resuscitator...51 Changing INOMAX Cylinders...52 High Calibration Connection Diagrams...56 INOmax DSIR Disposable Adapters...58 Part No. 20131 Rev-02 2012-09

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Pre-Use Checkout

Pre-Use Checkout Outline A.

Initial Connections

B.

High Pressure Leak Test

C.

Low Range Calibration

D.

Purge and Alarm Verification

E.

Backup INOMAX Delivery Test

F.

INOmax DSIR Performance Test

G.

INOblender Test

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Part No. 20131 Rev-02 2012-09

Pre-Use Checkout

A. Initial Connections 1. Check white plastic tip.

2. Connect high pressure regulator.

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6

Pre-Use Checkout 3. Connect the INOMAX regulator hose to one of the INOMAX inlets 4. Connect the INOblender inlet hose to the INOmax DSIR blender outlet 5. Connect the infrared cable to the back of the INOmax DSIR 6. Connect the oxygen hose to the INOblender oxygen inlet 7. Ensure the water separator cartridge/water trap bottle/ sample line and injector module are all in place 8. Turn INOmax DSIR ON, verify speaker function. 3

7

4 5

7

8 6

7 7

Part No. 20131 Rev-02 2012-09

Pre-Use Checkout

B. Perform High Pressure Leak Test (Open/Close INOMAX cylinder valve) Wait 30 seconds and ensure no pressure drop. Note: Make sure INOmax DSIR backup and INOblender are OFF.

C. Perform Low Range Calibration (second menu level)

Note: Once the calibration is completed (bars turn green and single tone sounds) press the menu button twice to return to the main screen. Part No. 20131 Rev-02 2012-09

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Pre-Use Checkout

1 10

2 1. 2. 3. 4. 5.

3

4

9

5

8

7

6

O2 Flowmeter (Connected to wall/tank) O2 Tubing 15M x 4.5mm Adapter 22M / 15F x 22M / 15F Adapter Injector Module

6. 7. 8.

300mm of 22mm Hose Gas Sample Tee Patient Gas Sample Line with Nafion 9. NO/N2 Injector Tube 10. Injector Module Electrical Cable

(Assemble connectors and tubing as shown)

D. Perform Purge and Alarm Verification 1.

Ensure cylinder valve is closed.

2.

Set O2 flowmeter to 10 L/min.

3.

Purge INOmax DSIR. a. Set INOMAX dose to 40 ppm b. “Cylinder Valve Closed” alarm will occur c. Cylinder gauge pressure should drop to 0 psig d. Purge is complete when “Low NO/N2 Pressure” alarm activates

4.

Open cylinder valve.

5.

Turn INOMAX dose to zero (note: The “Set Dose is Zero, Close Cylinder Valve” indicator will appear). 9

Part No. 20131 Rev-02 2012-09

Pre-Use Checkout

E. Perform Backup INOMAX Delivery Test 1. Turn backup delivery ON. 2. V  erify “Backup ON” alarm activates. 3. Verify values. NO = 14-26 ppm NO2 = <1.0 ppm

4. Turn backup delivery OFF.

F. Complete INOmax DSIR Performance Test Set Dose

40 ppm

1. Ensure oxygen flow of 10 L/min.

Acceptable NO Value

35-45 ppm

2. Set INOMAX dose to 40 ppm and allow values to stabilize.

Acceptable NO2 Value <1.5 ppm FiO2

Part No. 20131 Rev-02 2012-09

95% ±3%

3. Verify values (see table). 4. Turn the INOMAX dose to zero. 10

Pre-Use Checkout

G. Perform INOblender Test Note: Ensure INOblender inlet hose is connected to the back of the INOmax DSIR and the quick-connect cover is in place. 1. Remove the Pre-Use setup oxygen tubing from the oxygen flowmeter and connect it to the front of the INOblender. 2. Remove the Injector Module from the Pre-Use set-up and reconnect adapters.

2

4

40 ppm 3

5 3. On the INOblender, set INOMAX dose to 40 ppm and O2 flow to 10 L/min. 4. Verify values on the INOmax DSIR. 5. Turn the dose and flow to zero and remove the Pre-Use set-up from the INOblender.

3 10 L/min 5 1

2

Acceptable NO Value

32 - 48 ppm

The INOmax DSIR is now ready to connect to the patient. • Set the INOMAX dose to be delivered to the patient. • Set the appropriate alarm settings on the INOmax DSIR and breathing device.

WARNING: If not starting therapy within 10 minutes, depressurize the INOMAX regulator.

End of Pre-Use Checkout 11

Part No. 20131 Rev-02 2012-09

Backup INOMAX Delivery

WARNING: When the backup NO delivery mode is used, a flow of at least 5.0 L/min should be present in the ventilator circuit to avoid INOMAX concentrations greater than 40 ppm. The backup is intended for short term use when the electronic delivery system fails until a replacement NO delivery can be brought to the bedside. If the backup is on, along with the main delivery system an INOMAX value greater than set will be delivered (a high priority alarm will be present). The backup mode delivers a variable concentration of NO to the patient depending on the ventilator flow being used. See table below for details. The table below indicates the nominal concentrations delivered for different ventilator gas flows.

Ventilator/Gas Flow (L/min)

5

7.5

10

15

20

NO Concentration (ppm)

40

27

20

13

10

INOMAX cylinder conc. X 0.25 L/min / ventilator flow = delivered dose

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Backup INOMAX Delivery The backup delivery provides a fixed flow of 250 mL/min of INOMAX directly into the ventilator circuit through the Injector Module. Backup NO delivery is completely pneumatic and is not reliant on the operation of the main system.

Backup delivery mode OFF.

Backup delivery mode ON (with a Low Priority alarm). 13

Part No. 20131 Rev-02 2012-09

Transport Regulator/ Cap Assembly

Transport Regulator/Cap Assembly WARNING: • A new INOMAX cylinder and regulator must be purged before use to ensure the patient does not receive greater than 1.0 ppm of NO2. • Loss of communication between the INOmax DSIR and the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery. Caution: When using the Transport Regulator/Cap Assembly (PN 10022) ensure the cap is in place on the cylinder and the infrared cable is connected to the infrared connector port on the back of the INOmax DSIR. Note: Check the INOMAX cylinder for the correct product identity labels, cylinder concentration and expiration date. Ensure the INOMAX gas cylinder has more than 200 psig.

Step One Note: Ensure the white plastic tip is in place on the regulator connector and not chipped or cracked (see Figure 2). Connect a high pressure regulator to an INOMAX cylinder and tighten the fitting to the INOMAX cylinder (see Figure 1). Figure 1 Part No. 20131 Rev-02 2012-09

Figure 2 14

Transport Regulator/ Cap Assembly Step Two Connect the INOMAX regulator hose to one of the INOMAX inlets on the back of the INOmax DSIR (see Figure 3).

Figure 3

Step Three Connect the Infrared cable from the Transport Regulator/Cap Assembly to the back of the INOmax DSIR (see Figure 4).

Figure 4 15

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Transport Regulator/ Cap Assembly Step Four Place the Cap Assembly over the INOmeter (see Figure 5). Note: Be sure to align the keyway inside the Cap Assembly with the iButton on the INOmeter (see Figure 5 and 6). iButton

The electrical cord exits the cap directly above the iButton keyway

Figure 5

Figure 6

Step Five Grasp the Cap Assembly to open cylinder valve (see Figure 7 and 8).

-CLOSE Figure 7 Part No. 20131 Rev-02 2012-09

Figure 8 16

+OPEN

Transport Regulator/ Cap Assembly Final Set-up Diagram The following diagram and photo illustrates all of the components connected.

Additional Information Communication will take place between the INOmax DSIR and the INOmeter after the boot up phase of the INOmax DSIR is complete. Note: Cylinder icons are not visible and the dose control button will remain inactive until the INOmax DSIR recognizes an INOMAX cylinder. Note: When using the Transport Regulator/Cap Assembly only one cylinder will be displayed (see Figure 9).

Proceed with the INOmax DSIR Pre-Use Checkout (see page 6) Figure 9 17

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Oxygen Dilution Chart For delivery with 800 ppm cylinder of INOMAX (nitric oxide) for inhalation. (Illustrative Only)

INOMAX Dose

Set FiO2

10

.21

.40

.60

.80

1.00

0.21

0.40

0.59

0.79

0.99

20

!

0.20

0.39

0.59

0.78

0.98

40

!

0.20

0.38

0.57

0.76

0.95

80

!

0.19

0.36

0.54

0.72

0.90

Actual FiO2

Caution FiO2 less than 21%

Please Note: The calculations on this chart have been determined based on an 800 ppm cylinder of INOMAX (nitric oxide) for inhalation. This chart is representative of a range of doses available on the INOmax DSIR and doses higher than 20 ppm are not intended as the recommended therapeutic dose. Calculations are considered estimates and may vary under clinical conditions. All numbers have been rounded to the nearest hundredth.

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Duration Chart (88-size)

INOMAX Cylinder 88-Size

For an 88-Size 800 ppm Cylinder Concentration* (Illustrative Only)

INOMAX Dose

FLOW 5 L/min

10 L/min

20 L/min

40 L/min

5 ppm

43.3 Days

21.7 Days

10.8 Days

5.4 Days

10 ppm

21.5 Days

10.7 Days

5.4 Days

2.7 Days

20 ppm

10.6 Days

5.3 Days

2.6 Days

31 Hours

40 ppm

5.2 Days

2.6 Days

31 Hours

15 Hours

80 ppm

2.4 Days

29 Hours

14 Hours

7 Hours

This chart is representative of a range of doses available on the INOmax DSIR and doses higher than 20 ppm are not intended as the recommended therapeutic dose. * All calculations for the table above are based on a full cylinder of 2000 psig, 1963 liters “88” cylinder, and also accounting for cylinder change at 200 psig. The figures are calculated on total continuous flow cylinder conversion factor 0.98. • INOMAX flow = [Desired dose X total ventilator flow] / [Cylinder concentration - desired dose] • Cylinder volume = Cylinder conversion factor X cylinder pressure psig • Cylinder duration = Cylinder volume / INOMAX flow rate Calculations are considered estimates and may vary under clinical circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466). 19

Part No. 20131 Rev-02 2012-09

Duration Chart (D-size)

INOMAX Cylinder D-Size

For a D-Size 800 ppm Cylinder Concentration* (Illustrative Only)

INOMAX Dose

FLOW 5 L/min

10 L/min

20 L/min

40 L/min

5 ppm

7.8 Days

3.9 Days

46 Hours

23 Hours

10 ppm

3.9 Days

46 Hours

23 Hours

11 Hours

20 ppm

45 Hours

22 Hours

11 Hours

5 Hours

40 ppm

22 Hours

11 Hours

5 Hours

2 Hours

80 ppm

10 Hours

5 Hours

2 Hours

1 Hour

Typically used in transport

This chart is representative of a range of doses available on the INOmax DSIR and doses higher than 20 ppm are not intended as the recommended therapeutic dose. * All calculations for the table above are based on a full cylinder of 2000 psig, 353 liter “D” cylinder, and also accounting for cylinder change at 200 psig. The figures are calculated on total continuous flow cylinder conversion factor 0.18. • INOMAX flow = [Desired dose X total ventilator flow] / [Cylinder concentration - desired dose] • Cylinder volume = Cylinder conversion factor X cylinder pressure psig • Cylinder duration = Cylinder volume / INOMAX flow rate Calculations are considered estimates and may vary under clinical circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466). Part No. 20131 Rev-02 2012-09

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