INOmax DS Pocket Guide Rev 03

IMPORTANT: This guide is provided as a convenience and for general information only. Never use this product without clearly and thoroughly understanding the most recent revision of the INOmax® DS Operation Manual. The Operation Manual is the source for specific, updated information regarding warnings, cautions, checklists, diagrams, and/or instructions contained in this guide.

Contents Pre-Use Procedure...3-9 Backup INOmax® Delivery... 10-11 Oxygen Dilution Chart... 12 INOmax Cylinder Duration Chart...13-14 Circuit Connection Diagrams...15-28 ICU Ventilator Circuit... 15 Transport Ventilator Circuits...16-17 High Frequency Oscillatory Ventilator Circuits...18-19 Bunnell Life Pulse High Frequency Ventilator...20-21 Circle Anesthesia System with Ventilator... 22 Viasys Infant Flow SiPAP... 23 Viasys Infant Flow CPAP System... 24 Hamilton Arabella Nasal CPAP... 25 Vapotherm 2000i... 26 Spontaneous Breathing Mask Circuit... 27 Nasal Cannula... 28 Changing INOmax Cylinders...30-31 High Calibration Connection Diagrams...32-33 INOmax DS Disposable Adapters...34-35 Part No. 20009 Rev-03

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Pre-Use Procedure

Pre-Use Procedure 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® DS Performance Test G. INOblender® Test

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Part No. 20009 Rev-03

Pre-Use Procedure

A. Initial Connections 1. Check white plastic tip.

2. Connect high pressure regulator.

Part No. 20009 Rev-03

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Pre-Use Procedure 3. INOmax® IN. 4. Oxygen into blender (50 psi). 5. INOmax OUT to INOblender®. 6. Water separator cartridge/ sample line/Injector Module. 7. Turn INOmax® DS ON, verify speaker function.

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Part No. 20009 Rev-03

Pre-Use Procedure

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

C. Perform Low Range Calibration (second menu level)

Note: Once the calibration is completed (bars turn green) press the menu button twice to return to the main screen. Part No. 20009 Rev-03

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Pre-Use Procedure

D. Perform Purge and Alarm Verification 1

2 1. 2. 3. 4. 5.

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3

4

5

9

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7

6

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

6. 300mm of 22mm Hose 7. Gas Sample Tee 8. Patient Gas Sample Line 9. NO/N2 Injector Tube 10. Injector Module Electrical Cable

(Assemble connectors and tubing as shown) 1. Ensure cylinder valve is closed. 2. Set O2 Flowmeter to 10 L/min. 3. Set INOmax® dose to 40 ppm. 4. Purge is complete when “Low NO/N2 Pressure” alarm activates. 5. Open cylinder valve. 6. Turn INOmax dose to zero. 7

Part No. 20009 Rev-03

Pre-Use Procedure

E. Perform Backup INOmax® Delivery Test 1. Turn backup delivery ON.

2. V  erify “Backup ON” alarm activates.

3. Verify values.

INOmax Dose = 14-26 ppm NO2 = <1.0 ppm

4. Turn backup delivery OFF.

F. Complete INOmax® DS Performance Test Set INOmax Dose

40 ppm

1. Ensure oxygen flow of 10 L/min.

Acceptable INOmax Value

35-45 ppm

2. Set INOmax® dose to 40 ppm.

Acceptable NO2 Value <1.5 ppm FiO2

Part No. 20009 Rev-03

95% ±3%

3. Verify values. 4. Turn the INOmax dose to zero.

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Pre-Use Procedure

G. Perform INOblender® Test Note: Ensure INOblender inlet hose is connected to the back of the INOmax® DS and the quick-connect cover is in place (see insert). 40 ppm

10 L/min

Acceptable INOmax® Value

32 - 48 ppm

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

The INOmax DS is now ready to connect to the patient. WARNING: If not starting therapy within 10 minutes, depressurize the INOmax regulator.

End of Pre-Use Procedure 9

Part No. 20009 Rev-03

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 80 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

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Part No. 20009 Rev-03

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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. 11

Part No. 20009 Rev-03

Oxygen Dilution Chart

For delivery with 800 ppm cylinder of INOmax® (nitric oxide) for inhalation.

Set FiO2 INOmax Dose

.21

.40

.60

.80

1.00

5

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® DS and doses higher than 20ppm are not intended as the recommended therapeutic dose. All numbers have been rounded to the nearest hundredth.

Part No. 20009 Rev-03

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Duration Chart (88-size)

INOmax® Cylinder 88-Size For an 88-Size 800 ppm Cylinder Concentration* FLOW

INOmax Dose

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® DS and doses higher than 20 ppm are not intended as the recommended therapeutic dose. * All calculations are based on a full cylinder (2000 psig, 1963 liters “88”) changed at 200 psig. Based on total continuous flow. (psi conversion factor = 0.98) • INOmax flow = [Desired dose X total ventilator flow] / Cylinder concentration - desired dose • Cylinder volume = Cylinder conversion factor X cylinder 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). 13

Part No. 20009 Rev-03

Duration Chart (D-size)

INOmax® Cylinder D-Size For a D-Size 800 ppm Cylinder Concentration*

FLOW

INOmax Dose

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® DS and doses higher than 20 ppm are not intended as the recommended therapeutic dose. * All calculations are based on a full cylinder (2000 psig, 353 liters “D”) changed at 200 psig. Based on total continuous flow. (psi conversion factor = 0.17) • INOmax flow = [Desired dose X total ventilator flow] / Cylinder concentration - desired dose • Cylinder volume = Cylinder conversion factor X cylinder 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. 20009 Rev-03

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Circuit Connection Diagrams

ICU Ventilator Circuit 1

3

2

4

5

6

7 8

15

14

13

11 10 9

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1. 2. 3. 4. 5. 6. 7. 8.

Patient Wye Ventilator a Ventilator Expiratory Port Ventilator Inspiratory Port Patient Gas Sample Line Input Connection b INOmax® DS NO/N2 Injector Tube Front Panel Connection Injector Module Electrical Cable Front Panel Connection 9. Injector Module Electrical Cable Connection 10. Injector Module NO/N2 Injector Tube Connection 11. Humidifier Inlet 12. Humidifier 13. Humidifier Outlet 14. Patient Gas Sample Line 15. Gas Sample Tee 15

c

a. Injector Module b. 22F Inlet c. 22M / 15F Outlet

Part No. 20009 Rev-03

Circuit Connection Diagrams

Transport Ventilator Diagram 5

6

4 3 2 1

7 8

9 10 13

12

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1. Patient Wye 2. Expiratory Breathing Circuit Hose 3. Patient Gas Sample Line 4. Ventilator Expiratory Valve 5. Ventilator 6. INOmax® DS 7. Ventilator Inspiratory Port 8. 22M/15F X 22M/15F Adapter 9. Injector Module Electrical Cable 10. NO/N2 Injector Tube 11. Injector Module 12. Inspiratory Breathing Circuit Hose 13. Gas Sample Tee

Figure 1-1 Universal Mounting Post

WARNING: If the INOmax DS is to be used in a transport vehicle, it should be affixed to the transport mounting post (part number 10009), see Figure 1-1. Part No. 20009 Rev-03

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Circuit Connection Diagrams

Single-Limb Transport Ventilator Diagram 1

2

3

4

5

6

7 8

9 10 13

12

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1. PEEP Valve 2. Patient Wye 3. Circuit Hose 4. Patient Gas Sample Line 5. Ventilator 6. INOmax® DS 7. Ventilator Inspiratory Port 8. 22M/15F X 22M/15F Adapter 9. Injector Module Electrical Cable 10. NO/N2 Injector Tube 11. Injector Module 12. Inspiratory Breathing Circuit Hose 13. Gas Sample Tee

Figure 1-1 Universal Mounting Post

WARNING: If the INOmax DS is to be used in a transport vehicle, it should be affixed to the transport mounting post (part number 10009), see Figure 1-1. 17

Part No. 20009 Rev-03

Circuit Connection Diagrams

Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit 1

2

3 4

5 6

7 11

8

a c

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a. Injector Module b. 22F Inlet c. 22M / 15F Outlet

10 1. 2. 3. 4. 5. 6.

b

Sensormedics 3100A/B Ventilator Ventilator Outlet Injector Module INOmax® DS NO/N2 Injector Tube Connection Injector Module Electrical Cable Connection

7. One-Way Valve 8. Humidifier Inlet 9. Humidifier Outlet 10. Patient Gas Sample Line Connection 11. Bias Flow Tube

WARNING: Omission of the one-way valve may result in high NO delivery. Part No. 20009 Rev-03

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Circuit Connection Diagrams

Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit 1

3

2

4 5

6

7

15 14 9

8 9 10

a c b

13 12 1. 2. 3. 4. 5. 6. 7. 8.

a. Injector Module b. 22F Inlet c. 22M / 15F Outlet

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Sensormedics 3100A/B Ventilator Ventilator Outlet Injector Module Injector Module Electrical Cable Connection INOmax® DS NO/N2 Injector Tube One-Way Valve Paw Limit Valve Control

9. Filter 10. Humidifier Inlet 11. Humidifier Outlet 12. Bias Flow Tube 13. Patient Gas Sample Line Connection 14. Dump Valve Control 15. Paw Control Valve

WARNING: Omission of the one-way valve may result in high NO delivery. 19

Part No. 20009 Rev-03

Circuit Connection Diagrams

Connection to a Bunnell Life Pulse High Frequency Ventilator Circuit Caution: A one-way valve should be placed between the injector module and the humidifier chamber to prevent water from backing up into the injector module if the Life Pulse is either put into Standby or cycled OFF. Caution: There are higher pressures in the breathing circuit than normal; use only parts provided in disposable package #50046 and tightly secure all connections. 1

2

4

3

5

See Figure 1-3 See Figure 1-2

6 10 9 1. 2. 3. 4.

INOmax DS Bunnell Life Pulse Humidifier Humidifier

8

7

®

5. 6. 7.

Conventional Ventilator Life Port Adapter Endotracheal Tube

8. Sample Tee 9. Patient Box 10. Injector Module

WARNING: The INOmax® DS backup mode (250 mL/min.) should not be used with the Bunnell Life Pulse as ventilator flow rates are normally below the recommended ventilator flows. Part No. 20009 Rev-03

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