INOmax DS Pocket Guide Rev 02 Aug 2014

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 0DQXDOLVWKHVRXUFHIRUVSHFL¿FXSGDWHG LQIRUPDWLRQUHJDUGLQJZDUQLQJVFDXWLRQV FKHFNOLVWVGLDJUDPVDQGRULQVWUXFWLRQV contained in this guide.

Part No. 20540 Rev-02 2014-08

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©2014 Ikaria, Inc. INOMAX®, INOmax DSIR®, INOblender®, INOcal®, INOmeter® and INOvent® are registered trademarks of INO Therapeutics LLC. 3

Part No. 20540 Rev-02 2014-08

Contents Automated Pre-Use Checkout ...5 Integrated Pneumatic Backup INOMAX Delivery ...8 Transport Regulator/Cap Assembly ...10 Oxygen Dilution Chart ...14 INOMAX Cylinder 88-size Duration Chart ...15 INOMAX Cylinder D-size Duration Chart...16 Connection to Various Breathing Systems ...17 Acutronics Medical Systems AG Fabian +nCPAP Evolution ... 18 Acutronics Medical Systems AG Fabian HFO ... 19 A-Plus Medical Babi-Plus Bubble CPAP... 20 Bagging Systems While Using the Injector Module ...22 Bunnell Life Pulse High Frequency Ventilator Circuit ...24 Connecting INOmax DSIR Sample Tee to the Bunnell Life Pulse Circuit ...28 Connecting INOmax DSIR Injector Module to the Bunnell Life Pulse Circuit ...28 Circle Anesthesia System ...29  'UlJHU%DEORJ91,Q¿QLW$FXWH&DUH6VWHPDQG+HLQHQ Löwenstein Leoni-plus Ventilator ...30  )LVKHU 3DNHO+HDOWKFDUH%XEEOH&3$3 ...31  )LVKHU 3DNHO+HDOWKFDUH,QIDQW&LUFXLW1DVDO&DQQXOD ...32  )LVKHU 3DNHO+HDOWKFDUH2SWLÀRZ%UHDWKLQJ&LUFXLW ...33 Hamilton Arabella Nasal CPAP ...34 ICU Ventilator Circuit ...35 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit ...36 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit ...38 SLE Life Support SLE5000...39 Spontaneous Breathing Patient on a Mask Circuit ...40 Spontaneous Breathing Patient on a Nasal Cannula ...41  7HOHÀH[0HGLFDO&RPIRUW)OR+XPLGL¿FDWLRQ6VWHP...42 Transport Ventilator Circuit ...43 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  )LVKHU 3DNHO+HDOWKFDUH1HRSXII5HVXVFLWDWRU ...51 Changing INOMAX Cylinders ...52 High Calibration Connection Diagrams ...56 INOmax DSIR Disposable Adapters ...58 Part No. 20540 Rev-02 2014-08

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Pre-Use Checkout

Automated Pre-Use Checkout 1. Turn INOmax DSIR ON, verify speaker function. Note: A low range calibration automatically starts following the self test. A Pre-Use wizard will be displayed on the main screen, which will provide step-by-step instructions to complete the automated Pre-Use procedure.

- Pressing the NEXT button initiates the Pre-Use wizard. - Pressing the CANCEL button exits the Pre-Use wizard. If you cancel the pre-use wizard, the manual pre-use checkout procedure can be found on the INOmax DSIR Plus Pre-Use card, or in the INOmax DSIR Operation Manual, section 9/Appendix. The Pre-Use wizard can also be initiated by entering the menu screen and selecting the Pre-Use Checkout button. 5

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Pre-Use Checkout

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Pre-Use Checkout (Intentionally left blank)

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Part No. 20540 Rev-02 2014-08

Integrated Pneumatic Backup INOMAX Delivery Note: Use the integrated pneumatic backup function only for a short time, until a replacement delivery system can be obtained. The INOblender can also be used as a backup. If the main delivery system fails, the INOmax DSIR has an integrated pneumatic backup delivery function that allows the patient to remain connected to the ventilator. Backup NO delivery does not rely on the operation of the main system. The INOmax DSIR backup function: · Uses a pneumatic on/off switch and a restrictor built into the delivery side of the system. Â3URYLGHVD¿[HGÀRZRI,120$; P/PLQ LQWRWKH LQMHFWRUPRGXOH7KLV¿[HGÀRZSURYLGHVSSPRI12 ZKHQDGGHGWRDFRQWLQXRXVYHQWLODWRUJDVÀRZRI/PLQ WARNING: When using the integrated pneumatic backup with EUHDWKLQJFLUFXLWJDVÀRZVRI/PLQWKHGHOLYHUHG12 dose will be approximately 40 ppm. Breathing circuit JDVÀRZVOHVVWKDQ/PLQZLOOGHOLYHUDQ12GRVH greater than 40 ppm. The table below indicates the nominal concentrations GHOLYHUHGIRUGLIIHUHQWYHQWLODWRUJDVÀRZV 9HQWLODWRU*DV )ORZ /PLQ





10



20

NO Concentration SSP

40

27

20

13

10

,120$;FOLQGHUFRQF;/PLQYHQWLODWRUÀRZ HVWLPDWHGGRVH Part No. 20540 Rev-02 2014-08

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Integrated Pneumatic Backup INOMAX Delivery The main screen: · Indicates that backup delivery is on and that the set dose is turned off. · Displays the estimated dose that the patient should be UHFHLYLQJEDVHGRQWKHYHQWLODWRUÀRZ · Displays the NO concentration table Note: If the injector module is not functioning, the estimated backup dose graphic will be inactive.

%DFNXSGHOLYHUPRGH21 ZLWKD/RZ3ULRULWDODUP 

Backup delivery mode OFF. 9

Part No. 20540 Rev-02 2014-08

7UDQVSRUW5HJXODWRU Cap Assembly

7UDQVSRUW5HJXODWRU&DS$VVHPEO WARNING: ‡$QHZ,120$;FOLQGHUDQGUHJXODWRUPXVWEHSXUJHG before use to ensure the patient does not receive an excess level of NO2. ‡/RVVRIFRPPXQLFDWLRQEHWZHHQWKH,12PD['6IR 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 500 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 WKH¿WWLQJWRWKH INOMAX cylinder (see Figure 1). Figure 1 Part No. 20540 Rev-02 2014-08

Figure 2 10

7UDQVSRUW5HJXODWRU 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 11

Part No. 20540 Rev-02 2014-08

7UDQVSRUW5HJXODWRU 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).

&/26( Figure 7 Part No. 20540 Rev-02 2014-08

Figure 8 12

23(1

7UDQVSRUW5HJXODWRU 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 13

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Oxygen Dilution Chart For delivery with 800 ppm cylinder of ,120$; QLWULFR[LGH IRULQKDODWLRQ ,OOXVWUDWLYH2QO

INOMAX Dose

Set FiO2

10

.21

.40

.60

.80

1.00

0.21

0.40



0.79

0.99

20

!

0.20

0.39



0.78

0.98

40

!

0.20

0.38



0.76



80

!

0.19

0.36



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 VL]H

INOMAX Cylinder 88-Size For an 88-Size 800 ppm Cylinder Concentration* ,OOXVWUDWLYH2QO

,120$;'RVH SSP

)/2: /PLQ

/PLQ

/PLQ

/PLQ

5

39 Days

19.5 Days

9.8 Days

4.9 Days

10

19.4 Days

9.7 Days

4.8 Days

2.4 Days

20

9.6 Days

4.8 Days

2.4 Days

1.2 Days

40

4.7 Days

2.3 Days

1.2 Days

14 Hours

80

2.2 Days

1.1 Days

13.3 Hours 6.6 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 in the table above are based on a full cylinder, 138 bar (2000 psig), 1963 liter “88” cylinder, with a cylinder change at 14 bar (200 psig). The ¿JXUHVDUHFDOFXODWHGEDVHGRQDWRWDOFRQWLQXRXVEUHDWKLQJFLUFXLWJDVÀRZDQG a cylinder conversion factor of 14.2 liters per bar/0.98 liters per psig. ‡,120$;ÀRZ >'HVLUHGGRVHîWRWDOYHQWLODWRUÀRZ@·>&OLQGHUFRQFHQWUDWLRQ GHVLUHGGRVH@ ‡&OLQGHUYROXPH &OLQGHUFRQYHUVLRQIDFWRUîFOLQGHUSUHVVXUH EDUSVLJ ‡&OLQGHUGXUDWLRQ KRXUV   &OLQGHUYROXPH·,120$;ÀRZUDWH · Calculations are considered estimates and may vary under clinical circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466).

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Part No. 20540 Rev-02 2014-08

Duration Chart 'VL]H

INOMAX Cylinder D-Size

,120$;'RVH SSP

)/2: 5 L/min

10 L/min

20 L/min

40 L/min

5

7.0 Days

3.5 Days

1.8 Days

21 Hours

10

3.5 Days

1.7 Days

21 Hours

10.5 Hours

20

1.7 Days

20.7 Hours 10.3 Hours 5.2 Hours

40

20 Hours

10 Hours

5 Hours

2.5 Hours

80

9.5 Hours

4.8 Hours

2.4 Hours

1.2 Hours

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 in the table above are based on a full cylinder, 138 bar (2000 psig), 353 liter “D” cylinder, with a cylinder change at 14 bar (200 psig). The ¿JXUHVDUHFDOFXODWHGEDVHGRQDWRWDOFRQWLQXRXVEUHDWKLQJFLUFXLWJDVÀRZ and a cylinder conversion factor of 2.6 liters per bar/0.18 liters per psig. ‡,120$;ÀRZ >'HVLUHGGRVHîWRWDOYHQWLODWRUÀRZ@·>&OLQGHUFRQFHQWUDWLRQ GHVLUHGGRVH@ ‡&OLQGHUYROXPH &OLQGHUFRQYHUVLRQIDFWRUîFOLQGHUSUHVVXUH EDUSVLJ ‡&OLQGHUGXUDWLRQ KRXUV   &OLQGHUYROXPH·,120$;ÀRZUDWH · Calculations are considered estimates and may vary under clinical circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466).

Part No. 20540 Rev-02 2014-08

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Circuit Connection Diagrams Proper use of these products depends on careful reading and understanding of labeling and instructions. Please refer to the INOmax DSIR and INOblender operation manuals for guidance. Also UHIHUWRWKHVSHFL¿FEUHDWKLQJGHYLFHRSHUDWLRQPDQXDORULQVWUXFWLRQV for use.

INOmax DSIR Warnings: ‡ ,12PD['6IR subtracts gas from the breathing circuit via the JDVVDPSOLQJVVWHPDWP/SHUPLQXWHWKLVFDQDIIHFWWKH VHQVLWLYLWRIDÀRZWULJJHUHGVQFKURQL]HGEUHDWKPRGHRI some ventilators. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DSIR to the breathing circuit. ‡ 3DWLHQWGLVFRQQHFWDQGKLJKSUHVVXUHDODUPVDUHUHTXLUHGIRU the ventilator.

INOmax DSIR Cautions: ‡ ,QVHUWWKH,QMHFWRU0RGXOHRQWKHGUVLGHRIWKHEUHDWKLQJFLUFXLW SULRUWRWKHKXPLGL¿HU WKLVZLOOHQVXUHFRUUHFWÀRZPHDVXUHPHQW  ‡ $YRLGPHGLFDWLRQVLQWHUIHULQJZLWKWKHJDVPRQLWRULQJVVWHP administer any aerosolized medications distal to the sampling tee.

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Part No. 20540 Rev-02 2014-08

Circuit Connection Diagrams

Acutronics Medical Systems AG Fabian Q&3$3(YROXWLRQ YDOLGDWHGIRUXVHRXWVLGH RIWKH8QLWHG6WDWHV 1

4

3

2



14 6

13 12

7

11 1.  3. 4. 5. 6. 7.

10

9

Fabian+ nCPAP Evolution 3DWLHQW*DV6DPSOH/LQHZLWK1D¿RQ Injector Module Electrical Cable INOmax DSIR NO/N2 Injector Tube Connecting Tube (15 inches) Injector Module

Part No. 20540 Rev-02 2014-08

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8

8. 22F X 15M Adapter  +XPLGL¿HU 10. Inspiratory Breathing Circuit Hose 11. Gas Sample Tee 12. Patient Wye 13. Proximal Pressure Tube 14. Expiratory Breathing Circuit Hose

Circuit Connection Diagrams

Acutronics Medical Systems AG Fabian HFO YDOLGDWHGIRUXVHRXWVLGHRIWKH8QLWHG6WDWHV 1

3

2

4



6 7

 14

8 13

9

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

11

10

Fabian HFO Ventilator 3DWLHQW*DV6DPSOH/LQHZLWK1D¿RQ Injector Module Electrical Cable INOmax DSIR NO/N2 Injector Tube Injector Module T-Connector Assembly, #7209.e Connecting Tube (15 inches)

9. 22F X 15M Adapter  +XPLGL¿HU 11. Inspiratory Breathing Circuit Hose 12. Gas Sample Tee 13. Patient Wye 14. Proximal Pressure Tube 15. Expiratory Breathing Circuit Hose 19

Part No. 20540 Rev-02 2014-08

Circuit Connection Diagrams

A-Plus Medical Babi-Plus Bubble CPAP



1

14

2

13

12

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



3 4

11

10

8

7

9. Tee Adapter 10. Breathing Circuit  +XPLGL¿HU 12. NO/N2 Injector Tube 13. Injector Module Electrical Cable 14. INOmax DSIR  3DWLHQW*DV6DPSOH/LQHZLWK1D¿RQ

Oxygen Source Oxygen Tubing Pressure Relief Manifold Injector Module Temperature Probe 90 Degree Sample Port Adapter Nasal Prongs Babi Plus Bubble PAP Valve

Part No. 20540 Rev-02 2014-08

9

6

20