INOmax DS ir Operation Manual Rev -05 March 2012

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 3, and periodically as required. A defective Product should not be used. Parts that are broken, missing, visably worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, INO Therapeutics LLC d/b/a Ikaria® recommends that a telephone request for service advice be made to the nearest Field Technical Service Support Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ikaria. The Product must not be altered without the

prior written approval of Ikaria Quality Assurance Department. 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 Ikaria. 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. Ikaria products have unit serial numbers with coded logic which indicates the year of manufacture and a sequential unit number for identification.

20051234

The first four numeric digits indicate the year of product manufacture, and the next 4 digits are the sequential unit number produced.

10007

INOmax DSIR® part number

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.

©2012 Ikaria, Inc. INOMAX®, INOmax DSIR®, INOblender®, INOcal® and INOvent® are registered trademarks of INO Therapeutics, LLC. No license is conveyed, either expressed or implied, with the purchase hereof under U.S. Patent 5,485,827 and U.S. Patent 5,427,729 and their foreign equivalents. U.S. Patent 5,558,083 and foreign equivalents.

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Contents 1. General Information... 1 Introduction to this Manual... 2 Theory of Operation... 14 Environmental Effects... 18 2. Setup

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3. Pre-Use Checkout... 21 4. Patient Application... 29 INOblender® Operation... 31 Backup NO Delivery... 32 Transport Regulator/Cap Assembly Application... 33 Changing INOMAX® Cylinders and Purging the Regulatory Assembly... 37 Oxygen Dilution Chart... 39 Duration Chart INOMAX Cylinder 88-Size... 40 Duration Chart INOMAX Cylinder D-Size... 41 Monitoring the Environment... 45 Entering Patient Information... 46 Connection to Various Breathing Systems... 48 Bagging Systems While Using the Injector Module... 49 Bunnell Life Pulse High Frequency Ventilator Circuit... 52 Connecting INOmax DSIR® Sample Tee to the Bunnell Life Pulse Circuit... 53 Connecting INOmax DSIR Injector Module to the Bunnell Life Pulse Circuit... 53 Circle Anesthesia System... 54 Fisher/Paykel Healthcare Bubble CPAP... 56 Hamilton Arabella Nasal CPAP... 57 ICU Ventilator Circuit... 58 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit... 59. Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit... 60 Spontaneous Breathing Patient on a Mask Circuit... 61 Spontaneous Breathing Patient on a Nasal Cannula... 62 Teleflex Medical Comfort Flo Humidification System... 63 Transport Ventilator Circuit... 64 Vapotherm 2000i... 66 Vapotherm Precision Flow... 67 Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System... 68 Viasys Infant Flow SiPAP... 70 INOmax DSIR Patient Circuit Disposables... 72

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5. Alarms ... 73 6. Troubleshooting... 77 7. Calibration... 85 Low Range Calibration... 86 Oxygen Sensor High Range Calibration... 88 NO Sensor High Range Calibration... 90 NO2 Sensor High Range Calibration... 93 8. Maintenance... 97 Cleaning... 98 Replacing the O2, NO, and NO2 Sensors... 101 Replacing the H2O Separator Cartridge & INOMAX® Reg. Tip... 103 Cylinder Leak Check... 104 INOblender® Used as a Stand-Alone Device... 105 Preventative Maintenance... 106 Parts and Accessories... 107 9.

Product Specifications... 109

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General Information

(Delivery System)

1/ General Information

Part No. 20003 Rev - 01

Part No. 20010 Rev-05 2012-03

General Information

(Delivery System)

1/ General Information

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1/ General Information • The INOmax DSIR® (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 injector 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 INOmax DSIR provides continuous integrated monitoring of inspired O2, NO2 , and NO and a comprehensive alarm system.

WARNING: Warnings tell you 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.

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

Note:

• The INOmax DSIR incorporates a battery that provides up to 6 hours of uninterrupted INOMAX delivery in the absence of an external power source. • The INOmax DSIR includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup. • The target population is controlled by the drug labeling for INOMAX and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Important: Before using the INOmax DSIR, 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. Read the User Responsibility statement on the inside front cover of this manual; it describes what the user must do to maintain proper use and functioning of this product.

Notes provide clarification or supplemental information.

Blue arrow denotes required user action.

WARNING: • If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures. • Use only pharmaceutical grade NO/N2. • The INOmax DSIR 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. • The use of devices which radiate high intensity electrical fields may affect the operation of the INOmax DSIR. Constant surveillance of all monitoring and life support equipment is mandatory whenever interfering devices are in operation on or near a patient. • INO Therapeutics does not recommend that the INOmax DSIR be utilized with helium/ oxygen mixtures in any situation. The INOmax DSIR is intended to deliver INOMAX therapy gas only in conjunction with the delivery of air and oxygen. • Do not connect items, which are not specified as part of the system.

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Introduction to this Manual Definitions and abbreviations % v/v

% volume/volume

Control wheel

Rotary control used to change and confirm settings

Display

The electronic information panel on the front of the delivery system

HFOV

High frequency oscillating ventilator

Menu

A list of available choices for an operation

N2

Nitrogen

NO

INOMAX® (nitric oxide) for inhalation

NO2

Nitrogen dioxide

NO/N2

Nitric oxide (NO) and nitrogen (N2) gas mixture

O2

Oxygen

ppm

Parts Per Million

Resolved alarm

An alarm condition that has been corrected

Set NO

The dose of INOMAX set by the user

Touch screen

A display screen sensitive to touch used to select a function

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

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Sample Line Inlet Main Power Indicator Display Screen Alarm Speaker (under front label) Backup Switch Control Wheel Injector Module Tubing Outlet

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8. Injector Module Cable Inlet 9. Water Trap Bottle 10. Purge Port 11. INOMAX Gas Inlets 12. Blender Gas Outlet 13. Ethernet Port 14. Infrared Connector

Figure 1-1 INOmax DSIR® Front View

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15. USB Port 16. Water Separator Cartridge 17. Water Trap Bottle 18. Sample Gas Outlet Port 19. Power Cord Inlet 20. Ground 21. ON/Standby Switch 22. RS232 Port

Figure 1-2 INOmax DSIR Rear View

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1. 2. 3. 4. 5. 6. 7. 8. 9.

INOmax DSIR® Mounting Post INOMAX® Regulator (2) Small Part Bin INOMAX Cylinder Cylinder Holding Bracket Cylinder Mounting Strap Oxygen Cylinder Bracket Caster Lock Lever Caster (4)

Figure 1-3 INOmax DSIR and Cart

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Navigating the Display Screens There are five screens that can be displayed on the INOmax DSIR®. Note:

The specific level is identified by the highlighted card on the Menu Button. The red arrows indicate going back to a previous screen. Main Screen (first level)

Alarm History Screen (second level)

Patient Information Screen

Menu Screen (second level)

Calibration Screen (third level)

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Main Display Screen • On the Main Screen the user can view alarm messages, monitored values and graphical information.

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• By pressing the “Menu Button” on the touch screen (top right hand corner), the user can access the Menu Screen (see Figure 1-5).

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

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Alarm Silence Button Upper Alarm Limit Button Lower Alarm Limit Button Monitored Value Menu Button Text Message Area

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

13. Injector Module Icon 14. Delivery Line Icon 15. Backup Line Icon 16. Backup Switch Icon 17. Delivery Setpoint Display 18. NO Delivery Setpoint Button 19. Cylinder Icon

Figure 1-4 Main Display Screen 1

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Menu Screen (second level)

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• On the Menu Screen the user can change the alarm volume and the display brightness and view the software version. • To review the Alarm History Screen (second level), refer to Section 5/ Alarms.

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10 1. 2. 3. 4. 5.

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Software Revision Field Display Brightness Button Alarm Volume Button Return to Previous Level Button Monitor Area

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• It also lets the user select different calibration options (third level) which will be covered in Section 7/ Calibration.

6. Calibration Due Dates 7. NO Calibration Button 8. NO2 Calibration Button 9. Oxygen Calibration Button 10. Room Air Calibration Button

Figure 1-5 Menu Screen (second level)

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Display and user controls The INOmax DSIR® has a color touch screen display and a control wheel for adjusting and entering user settings. The buttons on the touch screen and the control wheel perform a variety of functions using a threestep procedure (see “Setting and making changes on the INOmax DSIR”). Note: • If a button has been selected and no activity has been sensed within 20 seconds, the display will return to its previous condition. If a button is de-emphasized (grayed out), it is not accessible. • Position delivery system so user screen is unobstructed and the speaker is not covered.

When a value is being changed, pressing the "Cancel Active Status" button during editing will stop the change and return the parameter to its original value (similar to the escape key on a computer).

Dose settings Displayed dose settings are 1, 5, 10, 20, 40, 60 and 80 ppm. Each click on the control knob corresponds to a known change in dose. The incremental dose per click corresponds to a value dependent upon the dose range in which the change is made, as illustrated in the table at right.

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Dose Setting Range Dose Change Per Click < 1 ppm 0.1 ppm 1 to 40 ppm 1 ppm 40 to 80 ppm 2 ppm

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Setting and making changes on the INOmax DSIR® The touch screen buttons and control wheel are used to: • Set the concentration of delivered NO • Adjust alarm limits • Silence alarms • Calibrate the sensors • Review alarm history • Define setup options • Enter patient identifier 1. SELECT (press) a button on the touch screen associated with the desired function. (an audible beep will sound when a button is selected, and the button will be displayed in inverse video)

2. ROTATE the control wheel clockwise or counterclockwise to adjust the value.

3. CONFIRM the selection by pressing the control wheel or the button associated with the desired function again. Note:

After confirming a desired dose, the NO alarm setting (high and low) will automatically be set for the first setting only. Any other changes will require the high and low alarm settings to be adjusted. Also, a two minute lockout period will prevent monitoring alarms from occurring while measured values stabilize.

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Settings Access the menu screen (second menu level). Alarm Volume setting 1. Push the alarm volume button on the touch screen. 2. Turn the control wheel to indicate the volume level you want. Choices range from 1 (softest) to 5 (loudest). 3. Push the control wheel to confirm your selection. 4. If you are finished with the Menu Screen push the return to previous level button on the touch screen.

Display Brightness setting 1. Push the display brightness button on the touch screen. 2. Turn the control wheel to indicate the display brightness level you want. Choices range from 1 (darkest) to 10 (brightest). 3. Push the control wheel to confirm your selection. 4. If you are finished with the Menu Screen, push the return to previous level button on the touch screen.

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Infrared Communication between the INOMAX® Cylinders and the 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 checks the INOMAX cylinder for the correct expiration date and cylinder concentration. The INOmax DSIR also transmits a confirmed patient identifier to the INOmeter on any open INOMAX cylinder. The INOmax DSIR cart (PN 10018) has a cover ( 1 ) 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 ( 2 ) (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 (see “Loading INOMAX Cylinders onto the INOmax DSIR Cart”, page 11).

IR Communication Interference The INOmax DSIR transceiver is located under the cart cover and should be protected from outside IR sources. The INOmax DSIR cart was designed to protect the INOmeter from external light/IR energy sources. The INOmax DSIR transceiver transmits via a 30 degree transmission cone projecting towards the floor (see dotted lines in Figure 1-6). The specifications of the IR beam call for it to have a range of 20 cm (7.9 in), so based on these specifications it would not affect other devices in the vicinity of the INOmax DSIR. The INOmeter uses a lower energy source which results in a lower IR beam range than the INOmax DSIR cart. The INOmeter does not transmit IR signals unless it mounted on the INOmax DSIR cart. If there is interference with the INOmax DSIR/INOmeter communication, the cylinder icon on the user screen will not be displayed and a “Cylinder Not Detected” alarm will activate. If IR communication interference occurs, we recommend you take the following actions: • Move the external IR source • Move the INOmax DSIR cart to reduce the external IR source in the area of the INOmeter • Shield the INOmeter from the suspect IR source If the actions listed above do not remedy this issue, the Transport Regulator/Cap Assembly could be utilized.

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External Light Interference High frequency and/or high intensity light emission, in the area of the INOmeter, may interfere with communication between the INOmax DSIR® and the INOmeter on the INOMAX cylinder. If there is interference with the INOmax DSIR/INOmeter communication, the cylinder icon on the user screen will not be displayed and a “Cylinder Not Detected” alarm will activate. Test results have demonstrated susceptibility to unintended infrared energy from artificial light sources. Most notably, various compact fluorescent lighting fixtures that focus or reflect light, increasing the light intensity in the vicinity of the INOmax DSIR cart, could affect INOmeter communications. If external light interference occurs, we recommend you take the following actions: • Move the interfering light source • Move the INOmax DSIR cart to reduce the high intensity light in the area of the INOmeter • Shield the INOmeter from the suspect light source If the actions listed above do not remedy this issue, the Transport Regulator/Cap Assembly could be utilized.

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Figure 1-6

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Loading INOMAX® Cylinders onto the INOmax DSIR® Cart Note:

Check the INOMAX gas cylinders for the correct product identity labels, cylinder concentration and expiration date.

Ensure at least one INOMAX gas cylinder (with more than 200 psig) is available. Refer to Section 3 / Pre-Use Checkout prior to use.

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Loading the first INOMAX cylinder on the cart 1 will result in a cylinder icon displayed on the screen 2 .

Loading a second INOMAX cylinder onto the cart 3 will result in a second cylinder icon displayed on the screen 4 .

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Symbols used in this manual or on the system Symbols replace words on the equipment and/or in this manual. These symbols include:

Attention, consult accompanying documents!

NO Gas Inlet

NO Gas Outlet

Alarm Silence

Equipotential Stud

On

Ethernet Port

Purge Location

Fuse Rating

Sample Gas Inlet Port

Infrared Input/Output

Sample Gas Outlet Port

Injector Module

Low Cal

SN

Low Range Calibration

Serial Number

Standby

REF

Main Power Connected

Stock Number

Type B Electrical Equipment

NO Backup OFF

USB Port

NO Backup ON

Water Separator Cartridge

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Theory of Operation The INOmax DSIR® provides a constant dose of INOMAX® into the inspiratory limb of the ventilator circuit. The INOmax DSIR uses a “dual-channel” design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas sensors (NO, NO2, and O2 sensors) and the user interface, including the display and alarms. The dualchannel approach to delivery and monitoring permits INOMAX delivery independent of monitoring. This allows the monitoring system to shutdown INOMAX delivery, if it detects a fault in the delivery system. For example, INOMAX delivery will shut down should the monitored NO concentration become greater than 100 ppm. (See Figure 1-7 for a schematic diagram).

6. A flow sensor inside the INOmax DSIR also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DSIR drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. 7. Gas Monitoring - The INOmax DSIR gas monitoring system provides monitored values for inspired NO, NO2, and O2. The sample gas is withdrawn from the breathing circuit and goes through a water trap, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring sensors. • The zero valve allows the gas sensors to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit.

1. INOMAX drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2000 psig. 2. The cylinder is attached to a high pressure regulator, which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DSIR using one of the two NO/ N2 quick connect inlets on the back of the machine. 3. The INOmax DSIR checks the INOMAX cylinder for the correct expiration date and cylinder concentration.

• The pump and sample flow sensor ensure a sample gas flow rate is maintained to the monitoring sensors. • The gas monitoring sensors are electrochemical; they are specific to each gas and provide an electronic signal which is proportional to the concentration of the gas present. 8. Backup Delivery - If the delivery system does go into shutdown, the INOmax DSIR has an integrated backup function which provides a fixed flow of INOMAX (250 mL/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOMAX will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOMAX delivery. The INOblender® can also be used as a backup.

4. The INOMAX enters the back of the INOmax DSIR, passes through a filter, then a safety shutoff valve, which is open under normal operation. 5. An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOMAX cylinder concentration and set INOMAX dose, the proportional solenoid valve delivers 800 ppm INOMAX into the ventilator circuit via the injector module where it mixes with the breathing circuit gas flow to achieve the set dose. This allows the INOmax DSIR to deliver a constant dose of

Part No. 20010 Rev-05 2012-03

INOMAX regardless of the ventilator flow pattern or breath rate (see Figure 1-8).

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