INOmax DS ir Plus Operational Manual Rev 03 July 2015

User Responsibility This Product will perform in conformity with the description contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked prior to use following the Pre-Use Checkout procedure described in section two. A defective Product should not be used. Parts that are broken, missing, visibly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, the manufacturer recommends that a telephone request for service advice be made to the local distributor. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer or local distributor. The Product must not be altered.

The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than INO Therapeutics LLC. Caution: U.S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A. and Canada, check local laws for any restrictions that may apply. Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local regulations. INO Therapeutics LLC products have unit serial numbers with coded logic which indicate the year of manufacture and a sequential unit number for identification.

Important: Before using the INOmax DSIR, Plus read through this manual. Read through the manuals for the ventilator, humidifier and any other accessory items used. Follow the manual instructions and obey the Warnings and Cautions. Keep this manual readily available to answer questions.

SN 20151234 Ref 10023 Ref 10085 Ref 10086

The first four numeric digits indicate the year of product manufacture, and the next 4 digits are the sequential unit number produced. INOmax DSIR, 800 ppm, English - Australia INOmax DSIR, 400 ppm, English - Europe INOmax DSIR, 800 ppm, English - Europe

Open Source Software A CD-ROM is available upon request containing the full source code to the open source software used within this product. Portions of this software are copyright © 1996-2002 The FreeType Project (www.freetype.org). All rights reserved. Korean fonts Baekmuk Batang, Baekmuk Dotum, Baekmuk Gulim, and Baekmuk Headline are registered trademarks owned by Kim Jeong-Hwan. ©2015 INO Therapeutics LLC INOMAX®, INOmax DSIR® Plus, INOmax® DS, INOmeter®, INOblender®, INOcal® and INOmax Total Care® are registered trademarks of INO Therapeutics LLC and their respective owners. INO Therapeutics LLC is a wholly-owned subsidiary of a Mallinckrodt company. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. ©2015 Mallinckrodt. No license is conveyed, either expressed or implied, with the purchase or usage hereof under any patent or patent application covering this product, including but not limited to U.S. Patent 5,485,827, 5,873,359, 5,558,083 and any respective foreign equivalents thereof.

Part No. 20573 Rev-03 2015-07

Contents

1/ G eneral Information ... 1-1 Indications for Use... 1-1 Introduction to this Manual ... 1-2 INOmeter Operation ... 1-18 Theory of Operation ... 1-22 Environmental Effects ... 1-26 2 / Automated P re-Use Checkout ... 2 -1 Initial connections ... 2-2 High Pressure Leak Test and Automated Purge ... 2-5 Integrated Pneumatic Backup INOMAX Delivery Test ... 2-7 Performance Test ... 2-8 INOblender Test ... 2-9 Depressurizing the Regulator Supply Line ... 2-10 3/ P atient Application ... 3-1 INOblender Operation ... 3-4 Integrated Pneumatic Backup NO Delivery ... 3-5 Changing INOMAX Cylinders and Purging the Regulator Assembly ... 3-8 Oxygen Dilution Chart ...3-11 Duration Chart INOMAX Cylinder Luxfer 10L-Size ... 3-12 Duration Chart INOMAX Cylinder Luxfer 2L-Size ... 3-13 Duration Chart INOMAX Cylinder 88-Size ... 3-14 Duration Chart INOMAX Cylinder D-Size ... 3-15 Monitoring the Environment ... 3-19 Entering Patient Information ... 3-20 Connection to V arious Breathing Systems ... 3-24 Acutronic Medical Systems AG F abian + nCPAP Evolution ... 3-24 Acutronic Medical Systems AG F abian HF O... 3-25 A-Plus Medical Babi-Plus Bubble CPAP Circuit ... 3-26 Bagging Systems While Using the Inj ector Module... 3-27 Bunnell Life Pulse High F requency V entilator Circuit ... 3-30 Connecting INOmax DSIR Plus Sample Tee to the Bunnell Life Pulse Circuit ... 3-31 Connecting INOmax DSIR Plus Inj ector Module to the Bunnell Life Pulse Circuit ... 3-31 CareF usion Infant F low CPAP System; Cardinal Airlife nCPAP System ... 3-32 CareF usion Infant F low SiPAP ... 3-33 Circle Anesthesia System... 3-36 r ger abylog 500 Infinity Acute are ystem and einen wenstein Leoni-plus V entilator ... 3-38 Fisher Paykel ealthcare ubble PAP ... 3-39 Fisher Paykel ealthcare Infant ircuit asal annula ... 3-40 Fisher Paykel ealthcare pti ow reathing ircuit ... 3-41 Hamilton Arabella Nasal CPAP ... 3-42 ICU V entilator Circuit ... 3-43 INOblender use with the NeoPuff ... 3-44 Sensormedics 3100A/B High F requency Oscillatory V entilator with a F iltered Circuit ... 3-45 Sensormedics 3100A/B High F requency Oscillatory V entilator with a Rigid or F lexible Circuit . 3-46 SLE Life Support SLE5000 ... 3-47 Spontaneously Breathing Patient on a Mask Circuit ... 3-48 Spontaneously Breathing Patient on a Nasal Cannula ... 3-49 Tele e edical omfort Flo umidification ystem ... 3-50 V apotherm 2000i ... 3-51 V apotherm Precision F low... 3-52

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4 / T ransport ... 4 -1 Transport Options ... 4-1 A. Intrahospital transport ( within the hospital) when moving the INOmax DSIR Plus as a unit ( cart and cylinders) ... 4-1 B. Intrahospital transport ( within the hospital) when removing the INOmax DSIR Plus and INOblender from the cart. ... 4-2 C. When using the INOblender as a stand-alone device. ... 4-6 INOblender Test Using the INOmax DSIR Plus to Analyze Output ... 4-8 INOblender Test... 4-9 INOblender Stand-Alone Pre-use Checkout ... 4-10 D. InterHospital Transport ( Between Hospitals) when using a separate INOmax DSIR Plus and INOblender for transport ...4-11 Duration Chart INOMAX Cylinder Luxfer 2L-Size ... 4-12 Duration Chart INOMAX Cylinder D-Size ... 4-13 Transport Regulator/Cap Assembly Application ... 4-14 Changing INOMAX Cylinders ... 4-17 Connection to a Dual-Limb Transport V entilator Circuit ... 4-20 Connection to a Single-Limb Transport V entilator Circuit ... 4-21 Cylinder Leak Check ... 4-23 5/ Alarms and T roubleshooting ... 5-1 Alarm Help...5-11 Alarm History ... 5-14 6/ Calibration ... 6-1 Low Calibration... 6-2 Oxygen Sensor High Calibration ... 6-4 NO Sensor High Calibration ... 6-7 NO2 Sensor High Calibration...6-11 7 / Maintenance ... 7 -1 Cleaning the INOmax DSIR Plus ... 7-2 Replacing the Water Separator Cartridge ... 7-8 Replacing the CGA 626 tip on the INOMAX regulator ... 7-8 Replacing the -ring on the I 51 5 I A regulator fitting ... 7-9 Cylinder Leak Check ... 7-10 Preventative Maintenance ...7-11 Parts and Accessories ... 7-12 / Product Speci cations... 8-1 V entilator Compatibility ... 8-2 RS 232 Data Output ... 8-8 Electromagnetic Compatibility Information ... 8-10 9/ Appendix ... 9-1 Manual Pre-Use Checkout ... 9-1

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arnings tell the user about dangerous conditions that can cause injury to the operator or the patient if you do not obey all of the instructions in this manual.

W AR NING : Caution:

Cautions tell the user about how to properly use the equipment and conditions that could cause damage to the equipment. Read and obey all warnings and cautions.

Note:

otes provide clarification or supplemental information.

Blue arrow denotes required user action.

W AR NING :

Changing Cylinders • Only use manufacturer supplied drug cylinders, regulators and adapters (see hanging INOM ylinders and Purging the egulator ssembly, Section / P atient Application) .

High Frequency Oscillatory and Jet Ventilator Circuits • Some high fre uency ventilator circuits re uire a one way valve to prevent high NO delivery. • Place the unnell ife Pulse in Standby prior to suctioning the patient to avoid NO delivery transiently exceeding the set dose by up to 0 ppm for 00 ppm cylinders. Press N to reestablish ventilation as soon as the catheter is removed from the airway. his will limit the extent of over delivery above the NO set dose. • Do not use dose settings above 40 ppm when using the FO option with the cutronic Fabian FO ventilator. idirectional ow through the Injector Module may cause over delivery which can lead to measured NO values greater than 100 ppm.

Integrated Pneumatic Backup •

he integrated pneumatic backup is intended for short term use when the electronic delivery system fails until a replacement NO delivery device can be brought to the bedside. • he integrated pneumatic backup delivers a variable concentration of NO to the patient depending on the ventilator ow being used. • hen using the integrated pneumatic backup with breathing circuit gas ows of 5 /min, the delivered NO dose will be approximately 40 ppm ( 00 ppm cylinder) or 0 ppm (400 ppm cylinder). reathing circuit gas ows less than 5 /min will deliver an NO dose greater than 40 ppm ( 00 ppm cylinder) or 0 ppm (400 ppm cylinder). • he integrated pneumatic backup ( 50 m /min.) should not be used with the unnell ife Pulse as ventilator ow rates can be very low at times, creating a potential delivered NO dose greater than 0 ppm.

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W AR NING :

Maintenance •

andle and dispose of sensors according to facility biohazard policies. Do not incinerate. • se only S cables that are shielded (see Section / Speci cations for more detail) . • If the injector module has been used in the wet/humidi ed part of the breathing circuit, it should be sterilized between each patient use.

Manually Bagging a Patient with an Injector Module •

he hyperin ation bag will, under some conditions, contain NO2 in excess of one ppm. se of large tidal volume breaths may expose the patients to the NO2 present in the bag for part of the breath. In general, if the inspiratory ow rate induced by the manual ventilation does not exceed the fresh gas ow rate, the patient should not be exposed to the concentrations of NO2 present in the hyperin ation bag. • dult and infant hyperin ation bags generate more NO2 when used at lower minute ventilation. If use of the bag is interrupted (for example to adjust the tracheal tube), before resuming ventilation of the patient, the user should s ueeze the bag several times to empty residual gas from the bag. • ecause of the potential for inhalation of excessive concentrations of NO2 , and the dif culty in monitoring the peak inhaled NO2 concentrations, ventilation with a hyperin ation bag or self in ating bag is intended only for short term use. • he monitoring system within the INOmax DSIR P lus will not detect generation of NO2 within the hyperin ation bag or self in ating bag devices and the alarms for excessive NO2 cannot warn of NO2 produced within the manual bag system. • o minimize the delivered concentration of NO2 , the following steps should be taken for use with the manual resuscitator bags oncentrations greater than 0 ppm NO should not be used because of excessive NO2 generation. se the smallest bag ade uate to deliver the desired tidal volume. Oxygen tubing lengths greater than inches should not be used (between the injector module and the bag). se the highest fresh gas ow rate (up to 15 /min) that is practical. se the lowest practical inspired oxygen concentration. fter starting fresh gas ow, s ueeze the bag several times to empty residual gas in the bag prior to using the system to ventilate a patient.

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W AR NING :

Manually Bagging a Patient with the INOblender •

he purge procedure must be followed to help ensure NO2 is purged from the system before the manual resuscitator bag is connected to the patient. • he manual bag should be s ueezed repeatedly during use to avoid NO2 building up in the bag. • If the bag is not s ueezed repeatedly while delivering INOM , the bag should be removed from the patient and the bag purge procedure performed before continuing. • he INOblender should be upright when setting the oxygen owrate for accurate setting. • Do not use pneumatically powered nebulizers with the INOblender. his will result in signi cant over delivery of INOM in excess of 0 parts per million (ppm) with 00 ppm cylinders and 40 parts per million with 400 ppm cylinders. he INOblender outlet pressure has been validated for use up to 400 millibar (5. psig) pressure. he amount of back pressure generated by pneumatic nebulizers is signi cantly greater 1.4 to .0 bar ( 0 0 psig) and will result in over delivery of INOM in excess of 0 ppm. he user adjusted dose setting on the INOblender will not correlate with, or have an effect on the actual delivered dose. In addition, the INOblender owmeter is not back pressure compensated and will display a lower ow rate than actual when pressure is applied to the outlet.

Purging the INOmax DSIR Plus •

ll INOmax DSIR Plus devices must be purged before use to ensure the patient does not receive an excess level of NO2 . • If the INOmax DSIR P lus is not going to be used on a patient within 10 minutes, depressurize the regulator supply line. • If the INOmax DSIR Plus is not used and is pressurized for more than 10 minutes, repeat automated or manual purge procedure. • If the INOmax DSIR Plus is depressurized and not used within 1 hours, repeat pre use procedure.

Transport • If the INOmax DSIR Plus or INOblender is to be used in a transport vehicle, they should be af xed to the transport mounting post, which is part of the transport mounting bracket assembly (part number 50041). • he transport mounting post and/or the transport mounting bracket assembly should be secured to the transport isolette/transport gurney in a manner which will secure the INOmax DSIR Plus/INOblender. • Only use one length of extension hose (part number 10014) between devices to minimize the risk of NO2 formation within the hose.

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W AR NING :

Troubleshooting or Calibrating • If an alarm occurs, safeguard the patient rst before troubleshooting or repair procedures. • se caution when troubleshooting the INOmax DSIR Plus delivery system while in use for a patient. •

brupt discontinuation of INOM may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., ebound Pulmonary ypertension Syndrome. o avoid abrupt discontinuation, utilize the INOblender or integrated pneumatic backup if necessary. If ebound Pulmonary ypertension occurs, reinstate INOM therapy immediately (See the INOM prescribing Information for further details.)

• If the high NO2 alarm activates, the delivery system should be assessed for proper set up while maintaining INOM delivery. djust the dose as described in the INOM Prescribing Information he ffects of Nitrogen Dioxide. If unable to determine the cause of the increased NO2 levels, call ustomer Support, do not discontinue therapy. • Do not change any sensor while delivering NO to a patient. • oss of communication between the INOmax DSIR Plus and the INOM cylinder for more than one hour will result in interruption of INOM delivery.

Use Outside of Product Labeling •

he INOmax DSIR Plus must only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOM (nitric oxide) drug package inserts and labeling. efer to this material prior to use. • elium/oxygen mixtures should not be used with the INOmax DSIR P lus. • he use of devices which radiate high intensity electrical elds may affect the operation of the INOmax DSIR Plus. onstant surveillance of all monitoring and life support e uipment is mandatory whenever interfering devices are in operation on or near a patient. • he approved patient population for the INOmax DSIR Plus, as speci ed in the drug labeling for INOM (nitric oxide) for inhalation, is limited to neonates. he INOmax DSIR P lus is not intended to be used in other patient populations. • Outside of the nited States, use of the INOmax DSIR P lus is limited to the use in accordance with INOM or INO o, nitric oxide for inhalation prescribing information as established with the national health authority.

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W AR NING :

Ventilators and Breathing Devices •

he INOmax DSIR Plus subtracts gas from the breathing circuit via the gas sampling system at 0 m per minute which can cause the ventilator to auto trigger. djusting the ow sensitivity may be necessary. he trigger sensitivity of the ventilator should be checked after connecting the INOmax DSIR P lus to the breathing circuit. • Set the INOmax DSIR P lus alarm thresholds for the current patient conditions to monitor any inadvertent changes in treatment. • e certain all cables and hoses are positioned to help prevent damaging or occluding them. • he use of pediatric and neonatal ventilator settings with adult size breathing circuits can result in higher levels of NO2 . lways use the size of breathing circuit that is appropriate for the patient. • he humidi er chamber volume should not be more than 4 0 m to prevent elevated NO2 values. he INOmax DSIR P lus should not be used with the iPap ision system or other single lumen breathing systems with bidirectional ow, as over dose of INOM (nitric oxide) and interruption of drug delivery to the patient may occur. • he patient gas sample tee must have the INOmax DSIR P lus sample line attached or be capped off to avoid loss of ventilator circuit pressure. • void recirculation of gases. ndesired recirculation of gases will occur if fresh gas ows are less than the patient minute volume. • Only use parts/accessories designated for use with this system.

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General Information

1/ General Information

PartNo. No.20003 20573 Rev Rev-03 Part - 01 2015-07

General Information

1/ General Information

Part No. 20573 Rev-03 2015-07

1/ G eneral Information Indications for Use

® The I ma IR Plus ( delivery system) delivers INOMAX ( nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide ( NO) , as set by the user, to the patient throughout the inspired breath. It uses a specially designed inj ector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The I ma IR Plus provides continuous integrated monitoring of inspired O2, NO2 , and NO and a comprehensive alarm system. The I ma IR Plus incorporates a battery that provides up to six hours of uninterrupted INOMAX delivery in the absence of an external power source. delivery capability that provides a fi ed ow of 250 m min The I ma IR Plus includes a backup of 800 ppm NO which along with user supplied 10 L/min of oxygen provides 20 ppm ( 10 ppm with 400 ppm gas) in the gas ow to a patients breathing circuit. It may also use the I blender for backup. se of the I ma IR Plus is limited to the use in accordance with INOMAX nitric oxide for inhalation prescribing information as approved with the national health authority.

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1-1

Introduction to this Manual De nitions and abbreviations T erm

De nition

%

%

v/v

volume/volume

Breathing circuit

Part of ventilator or breathing system that connects to the INOmax DSIR® Plus.

Breathing system

Non-invasive breathing devices.

Control wheel

Rotary control used to change and confirm settings.

Cylinder

Aluminum cylinder containing INOMAX® therapy gas.

HF OV

High frequency oscillatory ventilation.

INOblender®

Backup to the INOmax DSIR Plus. Allows manual ventilation of the patient, providing uninterrupted delivery of INOMAX.

INOMAX

Nitric oxide for inhalation.

INOmeter®

Counter mounted on a cylinder that records the amount of time the INOMAX cylinder valve is open.

Infrared ( IR)

Infra-red technology by which the INOmax DSIR Plus communicates with the INOmeter mounted on each cylinder.

N2

Nitrogen.

NO

Nitric oxide.

NO2

Nitrogen dioxide.

O2

Oxygen.

ppm

Parts per million.

Pre-use circuit

Connectors and tubing assembly required for INOmax DSIR Plus for pre-use checkout.

psig

Pounds per square inch gauge.

Set NO

Dose of INOMAX set by the user.

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This manual shows the Set NO displays associated with the 0-80 ppm range.

1 2

3

12

11 4

13

14

15

0

19

16

10

9

2 3

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

7

6

Sample Line Inlet Main Power Indicator Display Screen Alarm Speaker ( under front label) Integrated Pneumatic Backup Switch Control Wheel Inj ector Module Tubing Outlet Inj ector Module Cable Inlet

F igure 1-1 INOmax DSIR Plus F ront V iew

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5

2 2

9. Water Bottle 10. Purge Port 11. INOMAX Gas Inlets 12. INOblender Gas Outlet 13. Ethernet Port 14. Infrared Connector 15. USB Port 16. Water Separator Cartridge

2 1

18

17

17. Water Bottle 18. Sample Gas Outlet Port 19. Clamp Assembly 20. Electrical Cord Inlet 21. Equipotential Terminal 22. ON/Standby Switch 23. RS 232 Port

F igure 1-2 INOmax DSIR Plus Rear V iew

1-3

1 2

3 4

5 6

8 7 9

10

11 12

1. INOmax DSIR Plus 2. INOmax DSIR Plus Mounting Post 3. Clamp Assembly 4. INOMAX Regulator ( 2) 5. Small Part Bin 6. INOmeter 7. INOMAX Cylinder 8. Cylinder Holding Bracket 9. Cylinder Mounting Strap 10. Oxygen Cylinder Bracket 11. Caster Lock Lever 12. Caster ( 4)

F igure 1-3 INOmax DSIR Plus and Cart ( shown with 88-size, 800 ppm cylinders)

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1-5

Navigating the Display Screens

Note:

The specific level is identified by the highlighted card on the The red arrows indicate going back to a previous screen.

ain creen

Recent Alarms Screen ( second level)

enu utton.

(first level)

Patient Information Screen ( second level)

Menu Screen ( second level) Navigating the Menu Screen ( see page 1-8)

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Menu Screen ( second level)

Pre-Use Wizard

Automated Purge Screen

Alarm History Screen

Low Calibration Screen

High Calibration Screen

Settings Screen

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1-7

1 2

3

5 4

6

Main Display Screen n the main screen the user can view alarm messages, monitored values and graphical information. y pressing the enu utton on the touch screen ( top right hand corner) , the user can access the menu screen ( see F igure 1-5 ) .

7

8

19 1. 2. 3. 4. 5. 6.

18

17

16

15

Alarm Silence Button Upper Alarm Limit Button Lower Alarm Limit Button Monitored V alue Menu Button Text Message Area

14

13

12 11

10

9

7. Monitor Area 8. Graphical Area 9. Patient Information Button 10. Sample Line Icon 11. Water Bottle Icon 12. Inspiratory Limb Icon

13. Inj ector Module Icon 14. Delivery Line Icon 15. Integrated Pneumatic Backup Line Icon 16. Integrated Pneumatic Backup Switch Icon 17. Delivery Setpoint Display 18. NO Delivery Setpoint Button 19. Cylinder Icon

F igure 1-4 Main Display Screen 1 2

Menu Screen (second level) n the menu screen the user can access the Pre-Use Checkout ( # 1) and the Auto Purge ( # 2) wizards.

3

Note: 4

5

The Pre-Use Checkout and Auto Purge buttons are inactive ( greyed out) if a dose is set.

To review the complete alarm history, press the Alarm History button ( # 5) , ( refer to Section 5/ Alarms and Troubleshooting) . To initiate a low (room air) or high calibration, press either the Low Cal ( # 9) or High Cal ( # 7) buttons. ( refer to Section 6/ Calibration) .

10 1. 2. 3. 4. 5.

9 8

Pre-Use Checkout Button Auto Purge Button Return to Previous Level Button Monitor Area Alarm History Button

6 7

6. Settings Button 7. High Calibration Button 8. High Calibration Due Date 9. Low Calibration Button 10. Last Low Calibration Date

F igure 1-5 Menu Screen ( second level)

1-8

Press the ettings button ( 6) to view circuit ow and calculated delivery graphs, change display brightness, change alarm volume, change time zone and view software revision ( see F igure 1-6) .

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