(Delivery System)
`
`Operation Manual
`(800 ppm INOMAX® (nitric oxide) for inhalation)
`
`Part No. 20003 Rev - 01
`
`INO THERAPEUTICS EXHIBIT 2002
`Praxair Distribution v. INO Therapeutics
`IPR2015-00891
`
`

`
`(Delivery System)
`
`Operation Manual
`(800 ppm INOMAX® (nitric oxide) for inhalation)
`
`Part No. 20003 Rev - 01
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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.
`
`replacement become
`repair or
`Should such
`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
`
`10007
`
`The first four numeric digits indicate the year of product manufacture, and
`the next 4 digits are the sequential unit number produced.
`
`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.
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`Contents
`1. General Information ..............................................................................................................1
`
`
`Introduction to this Manual................................................................................................2
`
` Theory of Operation ........................................................................................................14
`
` Environmental Effects .....................................................................................................18
`
`2. Setup
`
` ..............................................................................................................................19
`
`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
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`Information
`
`General
`
`(Delivery System)
`
`1/ General Information
`
`Part No. 20003 Rev - 01
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`(Delivery System)
`
`Information
`
`General
`
`1/ General Information
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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.
`
`• 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.
`
` 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:
`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.
`
`1
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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
`
`1
`
`2
`
`3
`
`4
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`9
`
`10
`
`22
`
`8
`
`7
`
`6
`
`5
`
`21
`
`20
`
`19
`
`18
`
`17
`
`1. Sample Line Inlet
`2. Main Power Indicator
`3. Display Screen
`4. Alarm Speaker (under front label)
`5. Backup Switch
`6. Control Wheel
`7.
`Injector Module Tubing Outlet
`
`Figure 1-1 INOmax DSIR® Front View
`
`Injector Module Cable Inlet
`8.
`9. Water Trap Bottle
`10. Purge Port
`11. INOMAX Gas Inlets
`12. Blender Gas Outlet
`13. Ethernet Port
`14. Infrared Connector
`
`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
`
`Part No. 20010 Rev-05
`2012-03
`
`2
`
`

`
`1
`
`2
`
`5
`
`7
`
`8
`
`3
`
`4
`
`6
`
`9
`
`® Mounting Post
`INOmax DSIR
`1.
`INOMAX® Regulator (2)
`2.
`3. Small Part Bin
`4.
`INOMAX Cylinder
`5. Cylinder Holding Bracket
`6. Cylinder Mounting Strap
`7. Oxygen Cylinder Bracket
`8. Caster Lock Lever
`9. Caster (4)
`
`Figure 1-3 INOmax DSIR and Cart
`
`3
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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)
`
`Part No. 20010 Rev-05
`2012-03
`
`4
`
`

`
`1
`
`2
`
`3
`
`4
`
`5
`
`19
`
`18
`
`17
`
`16
`
`15
`
`14
`
`13
`
`12
`
`11
`
`10
`
`9
`
`1. Alarm Silence Button
`2. Upper Alarm Limit Button
`3. Lower Alarm Limit Button
`4. Monitored Value
`5. Menu Button
`6. Text Message Area
`
`7. Monitor Area
`8. Graphical Area
`9. Patient Information Button
`10. Sample Line Icon
`11. Water Trap Icon
`12. Inspiratory Limb Icon
`
`Figure 1-4 Main Display Screen
`
`1
`
`2
`
`3
`
`4
`
`6
`
`7
`
`8
`
`5
`
`6
`
`8
`
`7
`9
`10
`1. Software Revision Field
`6. Calibration Due Dates
`2. Display Brightness Button
`7. NO Calibration Button
`3. Alarm Volume Button
`8. NO2 Calibration Button
`4. Return to Previous Level Button
`9. Oxygen Calibration Button
`5. Monitor Area
`10. Room Air Calibration Button
`Figure 1-5 Menu Screen (second level)
`
`Main Display Screen
`• On the Main Screen
`
`the user can view alarm
` messages, monitored
` values and graphical
`
`information.
`
`• By pressing the “Menu
` Button” on the touch
` screen (top right hand
` corner), the user can
` access the Menu Screen
`
`(see Figure 1-5).
`
`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
`
`Menu Screen (second level)
`• 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.
`
`
`• It also lets the user select
` different calibration options
`
`(third level) which will be
` covered in Section
` 7/ Calibration.
`
`5
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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 three-
`step 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.
`
`Dose Setting Range Dose Change Per Click
`< 1 ppm
`0.1 ppm
`1 to 40 ppm
`1 ppm
`40 to 80 ppm
`2 ppm
`
`Part No. 20010 Rev-05
`2012-03
`
`6
`
`

`
`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.
`
`7
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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.
`
`Part No. 20010 Rev-05
`2012-03
`
`8
`
`

`
`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 ( ) with an infrared transceiver mounted
`1
`directly above each INOMAX cylinder. When INOMAX cylinders are loaded, communication
`will take place between the INOmax DSIR and the INOmeter ( ) (after the boot up phase of
`2
`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.
`
`9
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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.
`
`1
`
`2
`
`Figure 1-6
`
`Part No. 20010 Rev-05
`2012-03
`
`10
`
`

`
`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.
`
`2
`
`4
`
`1
`
`3
`
`Loading a second
`INOMAX cylinder onto
`the cart will result
`in a second cylinder
`icon displayed on the
`screen .
`
`3 4
`
`Loading the first
`INOMAX cylinder
`on the cart will
`result in a cylinder
`icon displayed on
`the screen .
`
`1 2
`
`11
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`(Intentionally left blank)
`
`Part No. 20010 Rev-05
`2012-03
`
`12
`
`

`
`Symbols used in this manual or on the system
`
`Symbols replace words on the equipment and/or in
`this manual. These symbols include:
`
`NO Gas Inlet
`
`NO Gas Outlet
`
`On
`
`Purge Location
`
`Sample Gas Inlet Port
`
`Sample Gas Outlet Port
`
`
`
`
`
`
`
`
`
`
`
`
`
`Attention, consult accompanying
`documents!
`
`Alarm Silence
`
`Equipotential Stud
`
`Ethernet Port
`
`Fuse Rating
`
`Infrared Input/Output
`
`Injector Module
`
` SN
`
`Serial Number
`
`Low Range Calibration
`
`
`
`Standby
`
`Main Power Connected
`
` REF
`
`Stock Number
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Low Cal
`
`
`
`Type B Electrical Equipment
`
`USB Port
`
`
`
`
`
`
`
`NO Backup OFF
`
`
`NO Backup ON
`
`
`
`
`
`
`
`
`
`Water Separator Cartridge
`
`13
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`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 dual-
`channel 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).
`
`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.
`
`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
`
`14
`
`INOMAX regardless of the ventilator flow pattern
`or breath rate (see Figure 1-8).
`
`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.
`
`• 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.
`
`

`
`Regulator
`
`Infrared
`
`®
`INOMAX
`Cylinder
`800 ppm
`
`DSIR Link CPU
`
`Monitor
`CPU
`
`Sample Gas Outlet Port
`
`F
`
`F
`
`NO
`Backup
`ON/OFF
`
`Restrictor
`
`Sensors
`
`O
`
`2
`
`NO
`
`NO
`
`2
`
`Sample Flow
`Sensor
`
`Sample Pump
`
`Zero Valve
`
`Water Trap
`
`Ventilator
`
`Sample
`Line
`
`Patient
`
`Expiratory Limb
`
`Breathing Circuit
`
`Sample Tee
`
`Inspiratory Limb
`
`Delivery
`CPU
`Pressure
`Switch
`
`Pressure
`Shut off valve
`
`Proportional
`Valve
`
`INOMAX Flow
`Sensor
`
`Injector
`Tubing
`
`Injector
`Module
`Cable
`
`Figure 1-7 Schematic Diagram of INOmax DSIR®
`
`Delivered Nitric Oxide (NO)
`Concentration using INOmax DSIR
`Delivery System
`
`Ventilator Flow
`
`Injector
`Module
`
`INOMAX
`
`Sample Gas
`
`Electronic
`
`Humidifier
`
`Figure 1-8 INOMAX injection method provides a constant NO concentration
`
`Time
`
`15
`
`Part No. 20010 Rev-05
`2012-03
`
`

`
`Effect of the INOmax DSIR® in a ventilator circuit
`Minute Volume
`There are two main effects of connecting and using
`the INOmax DSIR in a ventilator breathing circuit.
`When using volume ventilation with the INOmax DSIR,
`the measured tidal volume delivered to the patient
`• First, the INOmax DSIR adds NO/N2 gas to the
`shows small changes depending on the NO setting
` breathing circuit in proportion to the NO setting
`being used due to the addition and subtraction of
` and the ventilator flowrate. For example, at an 80
`gases by the delivery system. Some minor ventilator
` ppm NO setting (the maximum NO setting with
`adjustments to the minute volume may be required.
` an 800 ppm NO cylinder concentration) the
`The net result of the INOmax DSIR on the delivered
` INOmax DSIR adds 10% more gas to that delivered
`minute ventilation can be calculated as follows:
` by the ventilator, 5% more for a 40 ppm setting, etc.
`If the patient’s minute ventilation is 10 L/min
`• Second, the INOmax DSIR subtracts gas from the
` (500 cc X 20 breaths/min)
` breathing circuit via the gas sampling system at a
` nominal flow rate of 0.23 L/min.
`The additional minute volume due to the INOMAX
`can be calculated as follows:
`These two effects of adding and subtracting gas
`from the ventilator breathing circuit have the
`following effects:
`Oxygen Dilution
`The INOmax DSIR adds gas to the breathing circuit
`in proportion to the NO setting as described above.
`The NO/N2 mixture added to the ventilator gas
`dilutes the oxygen in proportion to the set INOMAX®
`dose. At an INOMAX dose setting of 80 ppm with a
`cylinder concentration of 800 ppm NO, the added
`gas is 10%. Thus, the O2 concentration is reduced by
`10% of its original value. For example, if the original
`O2 concentration is 50% v/v, then the value after
`injection, at the 80 ppm setting, should be 45% v/v.
`
`INOMAX dose x Minute Volume
`Cylinder Concentration -- INOMAX Dose = Additional INOMAX volume
`added per minute
`For a dose of 20 ppm the additional volume would be
` (20 X 10 / 800 – 20) = 0.25 L/min
`To calculate the net change in minute volume:
` 0.25 L/min INOMAX added - 0.23 L/min removed
`
` (sample system) = 0.02 L/min (net change)
`This formula may be used when calculating the
`changes to continuous flow on continuous flow
`ventilators as well (using the continuous flow in
`place of minute ventilation).
`Trigger Sensitivity
`The addition and subtraction of gases by the
`INOmax DSIR may affect the trigger sensitivity of
`the ventilator when using synchronized modes of
`ventilation. This may cause the ventilator to auto-
`trigger in ventilators which have flow trigger modes,
`especially where the trigger flow is set to less than
`1 L/min. The trigger sensitivity of the ventilator
`should be checked after connecting the
`INOmax DSIR delivery system.
`
`INOMAX Dose (ppm)
`80
`40
`20
`
`Oxygen Dilution % v/v
`10
`5
`2.5
`
`Part No. 20010 Rev-05
`2012-03
`
`16
`
`

`
`Circle Anesthesia Ventilator Systems
`
`The effect of the INOmax DSIR® on circle anesthesia
`ventilator systems (which use volume ventilation)
`is to cause small changes in the delivered minute
`volume as noted previously (see Minute Volume).
`Recirculation of INOMAX® in circle breathing systems
`should be avoided. The gas in the ventilator bellows
`may also contain undesirable levels of NO2 which
`may not be removed by the C