INOmaxDS IR MRI Operation Manual Rev 01 Aug 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 MRI, 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.

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Keep this manual readily available to answer questions.

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The first four numeric digits indicate the year of product manufacture, and the next four digits are the sequential unit number produced.

Ref 10074

INOmax DSIR Plus MRI, 800 ppm, English

Ref 10077

INOblender, 800 ppm

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 MRI, INOmax® DS, INOmeter®, INOblender®, INOcal®, INOmax Total Care® and INOvent® 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.

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Contents 1/ General Information... 1-1 Indications for Use... 1-1 Introduction to this Manual... 1-2 INOmax DSIR Plus MRI Cart Operation... 1-4 GaussAlert™ (gauss alarm)... 1-8 INOmeter Operation... 1-22 Theory of Operation... 1-26 Environmental Effects... 1-30 2/ Automated Pre-Use Checkout... 2-1 Initial connections... 2-3 High Pressure Leak Test and Automated Purge... 2-6 Integrated Pneumatic Backup INOMAX Delivery Test... 2-8 Performance Test... 2-9 INOblender Test... 2-10 Depressurizing the Regulator Supply Line...2-11 3/ Patient Application... 3-1 Using the INOmax DSIR Plus MRI in the MR Scanner Room... 3-2 Transferring to and from the MR scanner room... 3-2 INOblender Operation... 3-6 Integrated Pnuematic Backup NO Delivery... 3-7 Changing INOMAX Cylinders and Purging the Regulator Assembly... 3-10 Oxygen Dilution Chart... 3-13 Duration Chart INOMAX Cylinder 88-Size... 3-14 Entering Patient Information... 3-18 Connection to Various Breathing Systems... 3-22 Spontaneously Breathing Patient on a Nasal Cannula... 3-23 MR Conditional Ventilator Circuit ... 3-24 4/ Alarms and Troubleshooting... 4-1 Alarm Help... 4-12 Alarm History... 4-15 GaussAlert™ Alarm... 4-17 5/ Calibration... 5-1 Low-Range Calibration... 5-2 Oxygen Sensor High Calibration... 5-4 NO Sensor High Calibration... 5-7 NO2 Sensor High Calibration...5-11

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6/ Maintenance... 6-1 User Maintenance Schedule... 6-1 Testing the GaussAlert Function... 6-2 Cleaning the INOmax DSIR Plus MRI... 6-3 Replacing the O2, NO and NO2 Sensors... 6-7 Replacing the Water Separator Cartridge... 6-9 Cylinder Leak Check... 6-10 Preventative Maintenance...6-11 Parts and Accessories... 6-12 7/ Product Specifications... 7-1 MR Signal-to-Noise Ratio and Artifact Dimension Analysis... 7-4 Electromagnetic Compatibility Information... 7-5 RS 232 Data Output... 7-9 8/ Appendix... 8-1 Manual Pre-Use Checkout... 8-1 Additional Dose Setting Information... 8-4 Bypassing the INOmax DSIR Plus MRI and Connecting the INOblender Directly to the INOMAX Regulator... 8-5

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WARNING: Caution:

Warnings 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.

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

Note:

Notes provide clarification or supplemental information.

Blue arrow denotes required user action.

WARNING: Integrated Pneumatic Backup

• The 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. • The integrated pneumatic backup delivers a variable concentration of NO to the patient depending on the ventilator flow being used. • When using the integrated pneumatic backup with breathing circuit gas flows of 5 L/min, the delivered NO dose will be approximately 40 ppm. Breathing circuit gas flows less than 5 L/min will deliver an NO dose greater than 40 ppm.

Changing Cylinders • Only use manufacturer supplied drug cylinders, regulators and adapters (see Changing INOMAX Cylinders and Purging the Regulator Assembly, Section 3/ Patient Application). • Cylinders should be stored between 59-86 degrees F (15-30 degrees C). • Always secure a cylinder when not using it. • Never lift a cylinder by its valve. • Never drop a cylinder. • Never use a hammer, pry or wedge to loosen a valve or protection cap. The valve and protection cap should be operated by hand. • Never let oil, grease or other combustibles come in contact with a cylinder or valve. • Never remove or deface cylinder labeling or markings. • Never attempt to repair a leaking cylinder valve or its safety relief device. • Never operate equipment that is leaking. • Never ship a leaking cylinder. • Never store cylinders: - where damage can result from the elements, such as standing water or temperatures over 125 degrees F (52 degrees C). - where they can contact corrosive substances. - where they can be cut or abraded by an object. - next to a walkway, elevator or platform edge.

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WARNING:

Maintenance • Handle and dispose of sensors according to facility biohazard policies. Do not incinerate. • If the MR injector module has been used in the wet/humidified part of the breathing circuit, it should be sterilized between each patient use. • Do not use the RS 232 data output while in the MR scanner room. • Use only RS 232 cables that are shielded (see Section 7/ Product Specifications for more detail). • Keep the test magnet tool away from pacemakers, ICDs and other implanted medical devices.

Manually Bagging a Patient with a MR Injector Module • Do not place the injector module in-line with a manual resuscitation bag.

Manually Bagging a Patient with the INOblender

• The purge procedure must be followed to help ensure NO2 is purged from the system before the manual resuscitator bag is connected to the patient. • The manual bag should be squeezed repeatedly during use to avoid NO2 building up in the bag. • If the bag is not squeezed repeatedly while delivering INOMAX, the bag should be removed from the patient and the bag purge procedure performed before continuing. • The INOblender should be upright when setting the oxygen flowrate for accurate setting. • Do not use pneumatically powered nebulizers with the INOblender. This will result in significant over delivery of INOMAX in excess of 80 parts per million (ppm). - The INOblender outlet pressure has been validated for use up to 400 millibar (5.8 psig) pressure. The amount of back-pressure generated by pneumatic nebulizers is significantly greater (20-30 psig) and will result in over delivery of INOMAX in excess of 80 ppm. The user adjusted dose setting on the INOblender will not correlate with, or have an effect on the actual delivered dose. - In addition, the INOblender flowmeter is not back-pressure compensated and will display a lower flow rate than actual when pressure is applied to the outlet.

Purging the INOmax DSIR Plus MRI

• All INOmax DSIR Plus MRI devices must be purged before use to ensure the patient does not receive an excess level of NO2. • If the INOmax DSIR Plus MRI is not going to be used on a patient within 10 minutes, depressurize the regulator supply line. • If the INOmax DSIR Plus MRI is not used and is pressurized for more than 10 minutes, repeat automated or manual purge procedure. • If the INOmax DSIR Plus MRI is depressurized and not used within 12 hours, repeat pre-use procedure.

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WARNING:

Troubleshooting or Calibrating • If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures. • Abrupt discontinuation of INOMAX may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. To avoid abrupt discontinuation, utilize the INOblender or integrated pneumatic backup if necessary. If Rebound Pulmonary Hypertension occurs, reinstate INOMAX therapy immediately. (See the INOMAX prescribing Information for further details). • If the high NO2 alarm activates, the delivery system should be assessed for proper setup while maintaining INOMAX delivery. Adjust INOMAX and/or FiO2 as appropriate. (See INOMAX Prescribing Information for further details on the effects of Nitrogen Dioxide, NO2). If unable to determine the cause of the increased NO2 levels, call technical support and do not discontinue therapy. • Use caution when troubleshooting the INOmax DSIR Plus MRI while in use for a patient. When possible, replace the unit in question and perform troubleshooting procedure once the unit is removed from the MR scanner room. • Do not perform a high calibration procedure in the MR scanner room. Calibration equipment is a potential projectile hazard. • Do not remove rear sensor cover in the MR scanner room due to potential projectile hazard. • Do not change any sensor while delivering NO to a patient. • Loss of communication between the INOmax DSIR Plus MRI and the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery.

Use in a MR Environment

• A strong magnetic field such as that from an MRI system can affect the ability of the INOmeter to detect if the cylinder valve is open. This can cause a “Cylinder Valve Closed” alarm to occur when the cylinder valve is actually open. If this alarm occurs, reposition/rotate the INOmax DSIR Plus MRI cart outside the 100 Gauss area to reduce the magnetic interference in the area of the INOmeter until the cylinder handle graphic on the display turns green. This will resolve the “Cylinder Valve Closed” alarm. Typically the required INOmax DSIR Plus MRI cart location adjustment is less than 6 inches (15 cm) / 90 degrees. Note that Interruption of INOMAX therapy will occur one hour from point when the “Cylinder Valve Closed” alarm is activated if the alarm is not resolved. • Only use a size “88” (1,963 liters) cylinder that is marked “MR Conditional. Keep cylinder at 100 gauss or less.” with the INOmax DSIR Plus MRI while in the scanner room. Use of any other cylinder may create a projectile hazard. • The INOmax DSIR Plus MRI is classified as MR Conditional with MR scanners of 1.5 or 3.0 Tesla strength ONLY in areas where the field strength is less than 100 gauss. • This device contains ferromagnetic components and hence will experience strong attraction close to the magnet. It should be operated at a fringe field of less than 100 gauss. • Do not exceed 100 gauss; system operation may be impacted. Confirm cart auto-brake function. Optionally connect tether. • Verify at least one gauss alarm is functioning properly prior to use. • Do not use the INOmax DSIR Plus MRI if neither gauss alarm is functional.

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WARNING: Use in a MR Environment continued

• The gauss alarm will sound if the INOmax DSIR Plus MRI system is too close to the MR scanner. If alarm sounds, move system away from the MR scanner until the gauss alarm stops sounding. • Always verify that the INOmax DSIR Plus MRI auto-brake is engaged after positioning in the MR scanner room. • Always verify that the INOmax DSIR Plus MRI and INOblender are securely attached to the cart. • Never attach an oxygen cylinder to the INOmax DSIR Plus MRI cart. • Arrange power cord, MR patient gas sample line, MR injector tubing and MR injector module cable to avoid entanglement, strangulation and/or a trip hazard. • If the cart fails to move when the brake handle is pulled, or moves when the brake handle is not pulled, do not use the INOmax DSIR Plus MRI and contact your local representative.

Use Outside of Product Labeling • The INOmax DSIR Plus MRI must only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOMAX (nitric oxide) drug package inserts and labeling. Refer to this material prior to use. • Outside of the United States, use of the INOmax DSIR Plus MRI is limited to the use in accordance with INOMAX nitric oxide for inhalation prescribing information as established with the national health authority. • Helium/oxygen mixtures should not be used with the INOmax DSIR Plus MRI. • The use of devices which radiate high-intensity electrical fields may affect the operation of the INOmax DSIR Plus MRI. Constant surveillance of all monitoring and life support equipment is mandatory whenever interfering devices are in operation on or near a patient. • The target patient population is controlled by the drug labeling for INOMAX and is currently neonates. The INOmax DSIR Plus MRI is not intended to be used in other patient populations.

Ventilators and Breathing Devices • The INOmax DSIR Plus MRI subtracts gas from the breathing circuit via the gas sampling system at 230 mL per minute which can cause the ventilator to autotrigger. Adjusting the flow sensitivity may be necessary. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DSIR Plus MRI to the breathing circuit. • Set the INOmax DSIR Plus MRI alarm thresholds for the current patient conditions to monitor any inadvertent changes in treatment. • Be certain all cables and hoses are positioned to help prevent damaging or occluding them. • The use of pediatric and neonatal ventilator settings with adult size breathing circuits can result in higher levels of NO2. Always use the size of breathing circuit that is appropriate for the patient. • The humidifier chamber volume should not be more than 480 mL to minimize elevated NO2 values. • The patient gas sample tee must have the INOmax DSIR Plus MRI sample line attached or be capped off to avoid loss of ventilator circuit pressure. • Only use parts/accessories designated for use with this system.

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General Information

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1/ General Information Indications for Use

The INOmax DSIR® Plus MRI delivery system is indicated for delivery of 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. The INOmax DSIR Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling. The INOmax DSIR Plus MRI is indicated for continuous integrated monitoring of inspired O2, NO2, and NO. The INOmax DSIR Plus MRI is considered MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. The target patient population is controlled by the drug labeling for INOMAX and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.

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1-1

Introduction to this Manual Definitions and abbreviations % v/v

% volume/volume.

Auto-brake

The mechanism which stops the INOmax DSIR Plus MRI cart from rolling.

Auto-brake release

The yellow handle on the front of the INOmax DSIR Plus MRI cart that, when engaged, allows the cart to roll.

Breathing circuit

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

Breathing system

Non-invasive breathing devices.

Control wheel

Rotary control used to change and confirm settings.

Cylinder

Aluminum cylinder containing INOMAX therapy gas.

INOblender

®

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

INOMAX

NO (nitric oxide) for inhalation. Provided as a gas mixture of NO/N2 in an aluminum cylinder at a concentration of 800 ppm. Drug is administered by the INOmax DSIR Plus MRI.

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 communicates with the INOmeter mounted on each cylinder.

MRI

Magnetic Resonance Imaging.

MR Conditional

An item that has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use.

MR exclusion zone

Area in the MR scanner room where the magnetic field is greater than 100 gauss.

MR scanner

The MR device for diagnostic imaging.

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 MRI pre-use checkout.

psig

Pounds per square inch gauge.

MR scanner bore

The MR scanner opening.

MR scanner room

The room where the MR scanner is located.

Set NO

The dose of INOMAX set by the user.

Tether attachment point

A metal loop on the INOmax DSIR Plus MRI cart, where the user may fasten a tether to a secured point in the MR scanner room.

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

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Figure 1-1 INOmax DSIR Plus MRI Front View

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1. Sample Line Inlet 2. Main Power Indicator 3. Display Screen 4. Alarm Speaker (under front label) 5. Integrated Pneumatic Backup Switch 6. Control Wheel 7. MR Injector Module Tubing Outlet 8. MR Injector Module Cable Inlet 9. Water Bottle 10. Purge Port 11. INOMAX Gas Inlets 12. INOblender Gas Outlet 13. Ethernet Port 14. Infrared Connector 15. USB Port (disabled) 16. Water Separator Cartridge 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

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Figure 1-2 INOmax DSIR Plus MRI Rear View

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INOmax DSIR Plus MRI Cart Operation WARNING:

Note:

• Always verify that the INOmax DSIR Plus MRI auto-brake is engaged after positioning in the MR scanner room. • Always verify that the INOmax DSIR Plus MRI and INOblender are securely attached to the cart. • Verify at least one gauss alarm is functioning properly prior to use. Do not use the INOmax DSIR Plus MRI if neither gauss alarm is functional. • The gauss alarm will sound if the INOmax DSIR Plus MRI system is too close to the MR scanner. If alarm sounds, move system away from the MR scanner until the gauss alarm stops sounding. • If the cart fails to move when the brake handle is pulled or moves when the brake handle is not pulled, do not use the INOmax DSIR Plus MRI and contact your local representative.

• The INOmax DSIR Plus MRI cart provides an auto-brake to prevent inadvertent movement of the cart when in the scanner room. • To move the INOmax DSIR Plus MRI cart, pull up on the auto-brake handle, toward the cart handle. • Two gauss alarms are attached to the cart and will sound if the cart is moved too close to the scanner bore. • The tether attachment point allows for a facility supplied cable to be secured to the cart as a redundant means to limit the distance the cart can move.

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Pull the auto-brake handle up, toward the INOmax DSIR Plus cart handle, to disengage the auto-brakes. 2

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INOmax DSIR Plus MRI INOblender Gauss Alarm (2) (see page 1-8) Auto-brake Handle (see page 1-6) Cylinder Mounting Strap INOMAX Cylinder (2) Auto-brake Caster (2)

Figure 1-3 INOmax DSIR Plus MRI and Cart Front View

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Auto-brake Handle Gauss Alarm (2) Auto-brake Caster (2) INOmax DSIR Plus MRI Mounting Bolt INOblender MR Mounting Bolt Tether Attachment Point DM.P.0002

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Figure 1-4 INOmax DSIR Plus MRI and Cart Side View

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WARNING:

Always verify that the INOmax DSIR Plus MRI and INOblender are securely attached to the cart.

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Figure 1-5 INOmax DSIR Plus MRI and Cart

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INOmax DSIR Plus MRI Mounting Assembly INOMAX Regulator (2) INOmeter Gauss Alarm (2) (see page 1-8) INOMAX Cylinder (2) Tether Attachment Point

Figure 1-6 INOmax DSIR Plus MRI and Cart Rear View

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GaussAlert™ (gauss alarm) WARNING:

Verify at least one gauss alarm is functioning properly prior to use. Do not use the INOmax DSIR Plus MRI if neither gauss alarm is functional.

GaussAlert Features: The GaussAlert is designed to help keep the INOmax DSIR Plus MRI outside of the MR exclusion zone. The GaussAlert is programmed to alarm when the preset magnetic field strength is exceeded. It produces a distinct audio alarm when the INOmax DSIR Plus MRI is placed too close to the MR scanner bore. • When the equipment to which GaussAlert is attached is exposed to a magnetic field strength greater than GaussAlert’s set alarm threshold (100 gauss), a loud and piercing whoop tone will sound continuously as long as the unit remains in the exclusion zone. • The alarm will cease when the INOmax DSIR Plus MRI is moved away from the scanner bore to a location where the magnetic field strength is less than the alarm trip point (100 gauss). Additional Information: • The GaussAlert functionality should be checked monthly (see Section 6/Maintenance). • Mallinckrodt will provide all maintenance for the GaussAlert.

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1. Battery Indicator 2. Alarm Volume Adjustment 3. GaussAlert Side Bracket

Figure 1-7 GaussAlert Front View

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Figure 1-8 GaussAlert Side View

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Note:

The specific level is identified by the highlighted card on the Menu Button.

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Navigating the Display Screens

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Main Screen (first level)

Menu Screen (second level)

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Patient Information Screen (second level)

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Recent Alarms Screen (second level)

Navigating the Menu Screen (see page 1-11)

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