Mallinckrodt INOMAX DSir Plus Operation Manual
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Mallinckrodt INOMAX DSir Plus Operation Manual

800 ppm inomax (nitric oxide) for inhalation series 3 software
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Operation Manual
(800 ppm INOMAX® (nitric oxide) for inhalation)
Series 3 software
Part No. 20003 Rev - 01
Part No. 20717 Rev-01
2014-07

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  • Page 1 Operation Manual (800 ppm INOMAX® (nitric oxide) for inhalation) Series 3 software Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 2 Korean fonts Baekmuk Batang, Baekmuk Dotum, Baekmuk Gulim, and Baekmuk Headline are registered trademarks owned by Kim Jeong-Hwan. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademark of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owner. ©2016 Mallinckrodt No license is conveyed, either expressed or implied, with the purchase or usage hereof under any patent or patent application covering this product.

  • Page 3: Table Of Contents

    Contents 1/ General 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 Pre-Use Checkout ......................2-1 Initial connections ........................... 2-2 High Pressure Leak Test and Automated Purge ................2-5 Integrated Pneumatic Backup INOMAX Delivery Test ..............
  • Page 4 4/ Transport ............................4-1 Transport Options .......................... 4-1 A. Intrahospital transport (within the hospital) when moving the INOmax DS as a unit (cart and cylinders) ................4-1 B. Intrahospital transport (within the hospital) when removing the INOmax DS and INOblender from the cart.
  • Page 5 Warnings tell the user about dangerous conditions that can cause injury to WARNING: the operator or the patient if you do not obey all of the instructions in this manual. Cautions tell the user about how to properly use the equipment and conditions Caution: that could cause damage to the equipment.
  • Page 6 WARNING: High Frequency Oscillatory and Jet Ventilator Circuits • Some high frequency ventilator circuits require a one-way valve to prevent high NO delivery. • Place the Bunnell Life Pulse in Standby prior to suctioning the patient to avoid NO delivery transiently exceeding the set dose by up to 30 ppm. Press ENTER to reestablish ventilation as soon as the catheter is removed from the airway.
  • Page 7 WARNING: Manually Bagging a Patient with an Injector Module continued • To minimize the delivered concentration of NO , the following steps should be taken for use with the manual resuscitator bags: - Concentrations greater than 20 ppm NO should not be used because of excessive NO generation.
  • Page 8 WARNING: Use Outside of Product Labeling • The INOmax DS 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. •...
  • Page 9 WARNING: Ventilators and Breathing Devices • The INOmax DS subtracts gas from the breathing circuit via the gas sampling system at 230 mL per minute which can cause the ventilator to auto-trigger. Adjusting the flow sensitivity may be necessary. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DS to the breathing circuit.
  • Page 10 (Intentionally left blank) viii Part No. 20717 Rev-01 2014-07...

  • Page 11: 1/ General Information

    1/ General Information Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 12 1/ General Information Part No. 20717 Rev-01 2014-07...

  • Page 13: Indications For Use

    1/ General Information Indications for Use • The INOmax DS (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.

  • Page 14: Introduction To This Manual

    Introduction to this Manual Definitions and abbreviations Term Definition % v/v % volume/volume Breathing circuit Part of ventilator or breathing system that connects to the INOmax DS ® Breathing system Non-invasive breathing devices. Control wheel Rotary control used to change and confirm settings. Cylinder Aluminum cylinder containing INOMAX therapy gas.
  • Page 15 1. Sample Line Inlet 17. Water Trap Bottle 9. Water Trap Bottle 2. Main Power Indicator 18. Sample Gas Outlet Port 10. Purge Port 3. Display Screen 19. Clamp Assembly 11. INOMAX Gas Inlets 20. Electrical Cord Inlet 4. Alarm Speaker (under front label) 12.
  • Page 16 1. INOmax DS 2. INOmax DS Mounting Post 3. Clamp Assembly 4. INOMAX Regulator (2) 5. INOblender 6. Small Part Bin 7. INOmeter 8. INOMAX Cylinder 9. Cylinder Holding Bracket 10. Cylinder Mounting Strap 11. Oxygen Cylinder Bracket 12. Caster Lock Lever 13.
  • Page 17 (Intentionally left blank) Part No. 20717 Rev-01 2014-07...

  • Page 18: Navigating The Display Screens

    Navigating the Display Screens 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) Recent Alarms Screen Patient Information Screen Menu Screen (second level) (second level) (second level)
  • Page 19 Menu Screen (second level) Low Calibration Screen Settings Screen Pre-Use Wizard Alarm History Screen High Calibration Screen Automated Purge Screen Part No. 20717 Rev-01 2014-07...
  • Page 20 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 ). 1.
  • Page 21 Settings Screen (third level) • The circuit flow graph, combined with calculated delivery graph, is a user level tool to ascertain NO delivery system limitations in the context of mechanical ventilation. • The circuit flow rate graph displays the real time peak and average flow rate in the breathing circuit over a 10 second time period, as measured by the injector module.
  • Page 22 Display and user controls The INOmax DS 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 DS ”...
  • Page 23 Main Screen Cylinder icons are not visible and the NO delivery setpoint button will remain inactive until the INOmax DS recognizes an INOMAX cylinder. High frequency and/or high intensity light Caution: emission, in the area of the INOmeter, may interfere with communication between the INOmax DS and the INOmeter on the INOMAX cylinder (see page 1-15).
  • Page 24 Setting and making changes on the INOmax DS Dose settings Dose Setting Range Dose Change Per Click Displayed dose settings are 1, 5, 10, 20, 40, 60 and < 1 ppm 0.1 ppm 80 ppm. Each click on the control knob corresponds 1 to 40 ppm 1 ppm to a known change in dose.
  • Page 25 3. CONFIRM the selection by pressing the control wheel or the button associated with the desired function again. • After confirming a desired Note: dose, the NO alarm setting (high and low) will automatically be set for the first setting only. •...
  • Page 26 Settings Screen Adjustments Access the settings screen (third menu level). Display Brightness setting 1. Push the display brightness button on the touch screen. 2. Turn the control wheel to indicate the display brightness level desired. Choices range from one (darkest) to 10 (brightest). 3.
  • Page 27 Infrared Communication between the INOMAX Cylinders and the INOmax DS Loss of communication between the INOmax DS and the INOmeter for more WARNING: than one hour will result in interruption of INOMAX delivery. The INOmax DS has an interface using infrared (IR) technology which allows the INOmax DS communicate with the INOmeter (which is mounted to each INOMAX cylinder).
  • Page 28 External Light Interference High frequency and/or high intensity light emission, in the area of the INOmeter, may interfere Caution: with communication between the INOmax DS and the INOmeter on the INOMAX cylinder. If there is interference with the INOmax DS /INOmeter communication, the cylinder icon on the user screen will not be displayed and a “Cylinder Not Detected”...
  • Page 29 Loading INOMAX Cylinders Onto the INOmax DS Cart Check the INOMAX gas cylinders for the correct product identity labels, cylinder concentration Note: and expiration date. Loading the first Loading a second INOMAX cylinder INOMAX cylinder onto on the cart will the cart will result result in a cylinder...

  • Page 30: Inometer Operation

    INOmeter Operation • Removal of the INOmeter from the cylinder must be performed by authorized personnel. Do not dispose of the INOmeter. • INOmeter battery replacement is only to be performed by authorized personnel. • The INOmeter replaces the standard rubberized cylinder valve handle on the INOMAX cylinders and is used to open and close the cylinder valve.
  • Page 31 3. Press lock downward to remove from the INOmeter (see Figure 1-10). 4. The cylinder must be closed to reinsert the lock. Align directly across from the iButton and press upward into socket to attach lock Figure 1-10 (see Figure 1-11). •...
  • Page 32 When the cylinder valve is open and delivery is normal, the main screen shows the handle as green (see Figure 1-14). When two INOMAX cylinders are Note: loaded onto the cart and if both cylinder images do not appear on user screen, check to see if IR or light interference is suspected (see page 5-9 for troubleshooting).
  • Page 33 Symbols used in this manual or on the system Symbols replace words on the equipment and/or in this manual. These symbols include: Alarm Silence NO Gas Inlet Attention, consult accompanying NO Gas Outlet documents! 134˚C Autoclavable Not Autoclavable Average Flow Rate CE European Representative Peak Flow Rate CE Mark...

  • Page 34: Theory Of Operation

    Theory of Operation The INOmax DS provides a constant dose of 6. An internal flow sensor verifies the INOMAX INOMAX into the inspiratory limb of the ventilator flow from the proportioning valve, providing circuit. The INOmax DS uses a “dual-channel” design feedback to adjust the flow real time.
  • Page 35 Figure 1-15 Schematic Diagram of INOmax DS Figure 1-16 INOMAX injection method provides a constant NO concentration 1-23 Part No. 20717 Rev-01 2014-07...
  • Page 36 Effect of the INOmax DS in a ventilator circuit There are two main effects of connecting and using Minute Volume the INOmax DS in a ventilator breathing circuit. When using volume ventilation with the INOmax DS the measured tidal volume delivered to the patient 1.The INOmax DS adds NO/N gas to the...
  • Page 37 Circle Anesthesia Ventilator Systems The use of the INOmax DS with circle anesthesia When intermittent inspiratory flow rates are used, ventilator systems (which use volume ventilation peak ventilator flows which exceed 120 L/min causes small changes in the delivered minute may be achieved.

  • Page 38: Environmental Effects

    Environmental Effects Both these methods show that the exposure levels The National Institute for Occupational Safety and are significantly less than the levels recommended Health (NIOSH) have recommended exposure by NIOSH. limits as follows (Ref. 1). If the location for using NO has uncertain ventilation then the location should be evaluated for time-weighted (8 hours) average NO and NO...

  • Page 39: 2/ Automated Pre-Use Checkout

    2/ Automated Pre-Use Checkout Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 40 2/ Automated Pre-Use Checkout Part No. 20717 Rev-01 2014-07...
  • Page 41 Self Test Screen Turn ON INOmax DS An INOmax DS splash screen will appear once the device is turned ON followed by a Mallinckrodt test screen (confirm that the speaker sounds). • Low calibration automatically starts Note: following the INOmax DS self test.

  • Page 42: Initial Connections

    Initial connections 1. Confirm the water trap bottle and water separator cartridge are in place Connect the patient gas sample line with Nafion to the sample line inlet port on the front of the INOmax DS Check cables and hoses for signs of wear and damage.
  • Page 43 3. Connect the INOmax DS power cord to an emergency-power-backed hospital-grade outlet. The power cord must always be connected to an electrical outlet to maintain a full battery charge. Verify the main power supply indicator light is illuminated (green) . This indicates that the power cord is plugged into an electrical outlet.
  • Page 44 6. If using the INOblender with the INOmax DS , connect the INOblender inlet hose to the INOmax DS INOblender outlet and slide the quick-connect cover into place . Connect oxygen supply (wall source or cylinder oxygen, ) hose to O inlet fitting on back of INOblender .

  • Page 45: High Pressure Leak Test And Automated Purge

    High Pressure Leak Test and Automated Purge If you cancel the pre-use wizard or are unable to complete an automated purge, complete the high pressure leak test, manual purge and alarm verification starting on page 9-5. • A new INOMAX cylinder and regulator must be purged before use to ensure the WARNING: patient does not receive an excess level of NO •...
  • Page 46 5. Low Cylinder Pressure alarm may activate following purge sequence. Perform auto-purge with device plugged Note: in. Failure to do so may result in the procedure not completing. If this occurs, complete a manual purge (see page 9-6, Manual Purge). 6.

  • Page 47: Integrated Pneumatic Backup Inomax Delivery Test

    Integrated Pneumatic Backup INOMAX Delivery Test 1. Assemble pre-use set-up connectors and tubing (press SHOW DIAGRAM button if needed). Set the oxygen flowmeter to 10 L/min. (#1 in Figure 2-1). 1. O Flowmeter (Connected to wall/tank) 2. Injector Module Electrical Cable 3.

  • Page 48: Performance Test

    2. Turn the integrated backup INOMAX delivery to ON (250 mL/min.). Verify "Backup ON" alarm occurs. 3. Allow monitored values to stabilize (may take up to 3 minutes). Verify the NO and NO readings are within the following ranges: NO = 14-26 ppm ≤...

  • Page 49: Inoblender Test

    INOblender Test 1. Turn O flowmeter OFF and remove pre- use oxygen tubing from O flowmeter and connect to front of INOblender. 2. Remove the injector module from the pre-use set-up and reconnect the 40 ppm adapters. 3. On the INOblender, set the INOMAX dose to 40 ppm and INOblender flowmeter to 10 L/min.

  • Page 50: Depressurizing The Regulator Supply Line

    Depressurizing the Regulator Supply Line Depressurizing the regulator supply line removes the buildup of NO and allows the use of the INOmax DS ® at any time within the next 12 hours. If the regulator supply line is not depressurized, the INOmax DS must be used within 10 minutes after completing pre-use checkout procedure.

  • Page 51: 3/ Patient Application

    3/ Patient Application Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 52 3/ Patient Application Part No. 20717 Rev-01 2014-07...
  • Page 53 3/ Patient Application Before Operation Complete the initial connections and Pre-Use Checkout procedure as described in the previous sections before connecting the INOmax DS into the patient’s breathing circuit. (See the ventilator/breathing device manual for its setup and operation) • Set the INOmax DS alarm thresholds for the current patient conditions to WARNING: monitor any inadvertent changes in treatment.
  • Page 54 Connection to the ventilator breathing circuit The INOmax DS subtracts gas from the breathing circuit via the gas sampling WARNING: system at 230 mL per minute which can cause the ventilator to auto-trigger. Adjusting the flow sensitivity may be necessary. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DS to the breathing circuit.
  • Page 55 5. On the injector module, note the airflow direction arrow (Fig. 3-2, B). Flow from the ventilator must pass through the injector module in the direction of the arrow. 6. Select the dose button on the screen. On the INOmax DS , rotate the control wheel to set the NO dose.

  • Page 56: Inoblender Operation

    INOblender Operation Important: Read the INOblender Operation Manual PN 20732 before using the INOblender. Follow instructions and obey all Warnings and Cautions. • The purge procedure must be followed to help ensure NO is purged from the WARNING: system before the manual resuscitator bag is connected to the patient. •...

  • Page 57: Inoblender Used As A Stand-Alone Device

    INOblender Used as a Stand-Alone Device This section explains how to use the INOblender as a stand-alone device. Typically the INOblender receives INOMAX from the INOmax DS (INOMAX cylinder supplies both devices; see Figure 3-3). Figure 3-3 As a stand-alone device INOMAX cylinder supplies just the INOblender.

  • Page 58: Inoblender Use With The Neopuff

    INOblender use with the NeoPuff 1. Oxygen Source 6. Humidified Resuscitation System Circuit 2. Neopuff 7. Humidifier 3. T-Piece Circuit (with Duckbill Port) 8. Oxygen Tubing 4. Patient Connection 9. INOblender 5. Temperature Probe 10. INOMAX Inlet Figure 3-5 Part No. 20717 Rev-01 2014-07...

  • Page 59: Integrated Pneumatic Backup No Delivery

    Integrated Pneumatic Backup NO Delivery • When using the integrated pneumatic backup with breathing circuit gas flows of WARNING: 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. •...
  • Page 60 This table indicates nominal NO concentrations delivered for different ventilator gas flows. Ventilator Gas Flow (L/min) NO Concentration (ppm) INOMAX cylinder conc. x 0.25 L/min / ventilator flow = delivered dose • When the backup switch is turned OFF, the dose and alarm settings will return to the previous values (see Figure 3-7).
  • Page 61 Cylinder Information • Always secure a cylinder when not using it. WARNING: • Never lift a cylinder by its valve or valve protection cap or by using a chain, sling or magnet. • Never drop a cylinder. • Never use a hammer, pry or wedge to loosen a valve or protection cap. The valve and protection cap should operate by hand.

  • Page 62: Changing Inomax Cylinders And Purging The Regulator Assembly

    Changing INOMAX Cylinders and Purging the Regulator Assembly Caution: Replace an INOMAX cylinder when its pressure is less than 200 psig. 1. Check the INOMAX drug cylinders for the correct product identity, cylinder concentration, and expiration date. Verify cylinder has at least 500 psig (replace if 200 psig or less), and tighten the fitting to the INOMAX cylinder, attach a second INOmax DS...
  • Page 63 3. Insert the NO/N quick-connect fitting into the purge port on the back of the INOmax DS and firmly push until the regulator pressure gauge reads zero (this purges any NO that has accumulated in the hose and regulator). A new INOMAX cylinder and WARNING: regulator must be purged before use to ensure the...
  • Page 64 5. Open the cylinder valve on the new cylinder (this may activate the “Two Cylinders Open” alarm until the empty cylinder valve is closed). When using the transport regulator/ Caution: cap assembly (PN 10022) ensure the cap is fully seated and in place on the INOmeter and the infrared cable is connected and latched to the infrared connector port on...

  • Page 65: Oxygen Dilution Chart

    Oxygen Dilution Chart For delivery with 800 ppm cylinder of INOMAX (nitric oxide) for inhalation (Illustrative Only) Set FiO 1.00 0.21 0.40 0.59 0.79 0.99 0.20 0.39 0.59 0.78 0.98 0.20 0.38 0.57 0.76 0.95 0.19 0.36 0.54 0.72 0.90 Actual FiO Caution FiO less than 21%...

  • Page 66: Duration Chart Inomax Cylinder 88-Size

    Duration Chart INOMAX Cylinder 88-Size For an 88-Size 800 ppm Cylinder Concentration* (Illustrative Only) FLOW 5 L/min 10 L/min 20 L/min 40 L/min 39 Days 19.5 Days 9.8 Days 4.9 Days 19.4 Days 9.7 Days 4.8 Days 2.4 Days 9.6 Days 4.8 Days 2.4 Days 1.2 Days...

  • Page 67: Duration Chart Inomax Cylinder D-Size

    Duration Chart INOMAX Cylinder D-Size For an D-Size 800 ppm Cylinder Concentration* (typically used in transport) (Illustrative Only) FLOW 5 L/min 10 L/min 20 L/min 40 L/min 7.0 Days 3.5 Days 1.8 Days 21 Hours 3.5 Days 1.7 Days 21 Hours 10.5 Hours 1.7 Days 20.7 Hours 10.3 Hours 5.2 Hours 20 Hours...
  • Page 68 Emptying the Water Trap Bottle When handling any component of the patient circuit that comes in contact with WARNING: patient’s fluids wear protective safety equipment. The water trap bottle (see Figure 3-8) collects fluids separated from the patient gas sample. •...
  • Page 69 Running on Battery When running on battery with a circuit Note: flow greater than 20 L/min. and a set dose of 80 ppm, the delivered NO (measured NO value) may be less than the set dose. • When operating on the battery, a battery icon is displayed on the screen along with the message “Running on Battery”...
  • Page 70 Inspired Gas Sampling During Aerosol Delivery Caution: Pneumatic nebulizers will dilute the delivered INOMAX dose. • To avoid a “Sample Line/Filter Block” alarm condition, place the medication nebulizer downstream of the sample tee on the inspiratory limb to avoid over saturation of the water separator cartridge or contamination of the sample system (see Figure 3-9).

  • Page 71: Monitoring The Environment

    Monitoring the Environment The INOmax DS monitoring system can measure the environmental levels of NO and NO 1. Disconnect the sample line connector from the sample tee. 2. Cap the Luer fitting on the sample tee. Patient circuit pressure and WARNING: gas loss will result if cap is not placed (secured).

  • Page 72: Entering Patient Information

    Entering Patient Information The following are instructions of how to use the patient identifier screen. Note: • Any identifier entered will be linked with each INOMAX cylinder used during treatment. A patient identifier and patient details can be entered at any time during the treatment of a patient by pressing the patient information button in the right-lower corner of the main screen.
  • Page 73 Pressing the keys on the keyboard allows the user to enter a sequential alphanumeric identifier. Prior to confirming the identifier, digits can be changed either by pressing the backspace button or pressing the digit that has been entered and typing over it. The CONFIRM button will illuminate when six characters have been entered.
  • Page 74 Press the Select Diagnosis button and rotate the control wheel to select the patient diagnosis. Press the control wheel or button to confirm. Figure 3-15 Press the CONFIRM button to enter the patient details selected (see Figure 3-16). Figure 3-16 Prior to confirming the gestational age and birth weight, digits can be changed either by pressing the backspace button...
  • Page 75 Once the CONFIRM button has been Note: pressed, the patient details are stored (see Figure 3-18) and the identifier remains unchangeable until therapy is ended by turning the device to Standby (OFF). To access patient identifier information, press the patient information button on the main screen. Press the EXIT button to return to the main screen.

  • Page 76: Connection To Various Breathing Systems

    Connection to Various Breathing Systems • The INOmax DS should not be used with the BiPap Vision sytem or other WARNING: single-lumen breathing systems with bidirectional flow, as over-dose of INOMAX (nitric oxide) and interruption of drug delivery to the patient may occur. •...

  • Page 77: Acutronics Medical Systems Ag Fabian +Ncpap Evolution

    Acutronics Medical Systems AG Fabian +nCPAP Evolution Note: Validated for use outside of the United States. 1. Fabian+ nCPAP Evolution 8. 22F X 15M Adapter 2. Patient Gas Sample Line with Nafion 9. Humidifier 3. Injector Module Electrical Cable 10. Inspiratory Breathing Circuit Hose 4.

  • Page 78: Acutronics Medical Systems Ag Fabian Hfo

    Acutronics Medical Systems AG Fabian HFO Note: Validated for use outside of the United States. 1. Fabian HFO Ventilator 9. 22F X 15M Adapter 2. Patient Gas Sample Line with Nafion 10. Humidifier 3. Injector Module Electrical Cable 11. Inspiratory Breathing Circuit Hose 12.

  • Page 79: A-Plus Medical Babi-Plus Bubble Cpap Circuit

    A-Plus Medical Babi-Plus Bubble CPAP Circuit 1. Oxygen Source 9. Tee Adapter 2. Oxygen Tubing 10. Breathing Circuit 11. Humidifier 3. Pressure Relief Manifold 4. Injector Module 12. NO/N Injector Tube 5. Temperature Probe 13. Injector Module Electrical Cable 6. 90 Degree Sample Port Adapter 14.

  • Page 80: Bagging Systems While Using The Injector Module

    Bagging Systems While Using the Injector Module • The hyperinflation bag will, under some conditions, contain NO in excess of WARNING: one ppm. Use of large tidal volume breaths may expose the patients to the NO present in the bag for part of the breath. In general, if the inspiratory flow rate induced by the manual ventilation does not exceed the fresh gas flow rate, the patient should not be exposed to the concentrations of NO present in the...
  • Page 81 Bagging Systems While Using the Injector Module Caution: New O tubing must be used each time for optimal fit on the 4.5 mm adapter. 8. O Tubing Sample Tee 1. O Flowmeter (wall outlet or cylinder) 9. Patient Gas Sample Line with Nafion 2.
  • Page 82 To minimize the delivered concentration of NO , the following steps should be taken WARNING: for use with the manual resuscitator bags: • Use the smallest bag adequate to deliver the desired tidal volume. • Oxygen tubing lengths greater than 72 inches should not be used (between the injector module and the bag).
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  • Page 84: Bunnell Life Pulse High Frequency Ventilator Circuit

    Bunnell Life Pulse High Frequency Ventilator Circuit • The integrated pneumatic backup (250 mL/min.) should not be used with the WARNING: Bunnell Life Pulse as ventilator flow rates are normally below the recommended ventilator flows. • Place the Bunnell Life Pulse in standby prior to suctioning the patient to avoid NO delivery transiently exceeding the set dose by up to 30 ppm.

  • Page 85: Connecting Inomax Ds Ir Sample Tee To The Bunnell Life Pulse Circuit

    Connecting INOmax DS Sample Tee to the Bunnell Life Pulse Circuit 1. From Patient Box 2. Cut Green tube at midpoint (approximately six inches from the Life Port Adapter) 3. Patient Gas Sample Line with Nafion 4. Insert Sample Tee 5.

  • Page 86: Circle Anesthesia System

    Circle Anesthesia System • Avoid recirculation of gases. Undesired recirculation of gases will occur if fresh WARNING: gas flows are less than the patient minute volume and may result in: - Higher NO levels due to the limited ability of the carbon dioxide absorbent to remove NO - Higher NO concentrations than those set due to NO recirculated through the absorber.
  • Page 87 Circle Anesthesia System 10 10a 1. Patient Gas Sample Line with Nafion 9. Absorber 2. Patient Gas Sample Line Input Connection 10. Injector Module 3. INOmax DS a. Injector Module Input End 4. Bellows Assembly b. Injector Module Output End 5.

  • Page 88: Dräger Babylog Vn500/Infinity Acute Care System And Heinen & Löwenstein Leoni-Plus Ventilator

    Dräger Babylog VN500/Infinity Acute Care System and Heinen & Löwenstein Leoni-plus Ventilator WARNING: Omission of the one-way valve may result in high NO delivery. • Validated for use outside of the United States. Note: • Use a one-way valve (Part Number- 1605-3139-000) when ventilating during the HFOV mode. 1.

  • Page 89: Fisher & Paykel Healthcare Bubble Cpap

    Fisher & Paykel Healthcare Bubble CPAP 1. Oxygen Source 9. Bubble CPAP Generator 2. Oxygen Tubing 10. F/P Inline Infant Nebulizer Kit (RT010) Adapter 3. Bubble CPAP Pressure Manifold 11. Breathing Circuit 4. 22F X 15M Adapter 12. Humidifier 5. 22M/15F X 22M/15F Adapter 13.

  • Page 90: Fisher & Paykel Healthcare Infant Circuit Nasal Cannula

    Fisher & Paykel Healthcare Infant Circuit Nasal Cannula 1. Patient Gas Sample Line with Nafion 9. Injector Module Electrical Cable 2. INOmax DS 10. NO/N Injector Tube 3. Oxygen Source 11. Humidifier 4. Oxygen Tubing 12. Breathing Circuit 5. 22F X 15M Adapter 13.

  • Page 91: Fisher & Paykel Healthcare Optiflow Breathing Circuit

    Fisher & Paykel Healthcare Optiflow Breathing Circuit 13. 22M/15F X 22M/15F Adapter 1. Patient Gas Sample Line with Nafion 7. NO/N Injector Tube 14. 22 mm ID X 22 mm ID Cuff Adapter 8. 22F X 15M Adapter 2. INOmax DS 15.

  • Page 92: Hamilton Arabella Nasal Cpap

    Hamilton Arabella Nasal CPAP 1. Arabella 8. Humidifier 9. Heated Delivery Circuit 2. Patient Gas Sample Line with Nafion 3. INOmax DS 10. Temperature Probe 4. NO/N Injector Tube 11. Universal Generator 5. Injector Module Electrical Cable 12. Arabella Sample Tee 6.

  • Page 93: Icu Ventilator Circuit

    ICU Ventilator Circuit 1. Patient Wye 10. 22M/15F X 22M/15F Adapter 2. Patient Gas Sample Line with Nafion 11. Injector Module Electrical Cable Connection 3. Ventilator 12. Injector Module NO/N Injector Tube Connection 4. Ventilator Expiratory Port 13. 22F X 15M Adapter 5.

  • Page 94: Sensormedics 3100A/B High Frequency Oscillatory Ventilator With A Filtered Circuit

    Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit WARNING: Omission of the one-way valve may result in high NO delivery. Caution: Use only parts provided in disposable package #50250, and tightly secure all connections. 1. Sensormedics 3100A/B Ventilator 7.

  • Page 95: Sensormedics 3100A/B High Frequency Oscillatory Ventilator With A Rigid Or Flexible Circuit

    Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit WARNING: Omission of the one-way valve may result in high NO delivery. 8. 22 mm ID X 22 mm ID Cuff Adapter 1. Sensormedics 3100A/B Ventilator 9. Humidifier Inlet 2.

  • Page 96: Sle Life Support Sle5000

    SLE Life Support SLE5000 • Validated for use outside of the United States. Note: • A one-way valve is not required for use during high frequency ventilation mode. 1. Patient Wye 7. Injector Module 2. Patient Gas Sample Line with Nafion 8.

  • Page 97: Spontaneous Breathing Patient On A Mask Circuit

    Spontaneous Breathing Patient on a Mask Circuit 1. O Tubing 10. One-Way Valve 11. Sealed Face Mask 2. 15M X 4.5 mm Adapter 3. 22M/15F X 22M/15F Adapter 12. One-Way Valve 4. Breathing Circuit Tee 13. Patient Gas Sample Line with Nafion 5.

  • Page 98: Spontaneous Breathing Patient On A Nasal Cannula

    Spontaneous Breathing Patient on a Nasal Cannula The INOmax DS can be used with nasal cannula to deliver INOMAX concentrations from 5-80 ppm and an oxygen flow rate as low as two L/min. Conditioning of the oxygen flow prior to delivery through the injector module will help ensure the most accurate flow measurement.

  • Page 99: Teleflex Medical Comfort Flo Humidification System

    Teleflex Medical Comfort Flo Humidification System 7. Temperature Probe (Short Cable) 13. Injector Module Electrical Cable 1. Patient Gas Sample Line with Nafion 8. Angled 22 mm Connector 14. NO/N Injector Tube 2. INOmax DS 9. Patient Circuit 15. 22F X 15M Adapter 3.

  • Page 100: Vapotherm 2000I

    Vapotherm 2000i • The INOmax adds NO/N gas flow to the breathing circuit flow in proportion to the NO setting (up to 10% at 80 ppm) and subtracts gas from the breathing circuit via gas sampling at a nominal flow rate of 0.23 L/min. •...

  • Page 101: Vapotherm Precision Flow

    Vapotherm Precision Flow • The INOmax DS adds NO/N gas flow to the breathing circuit flow in proportion to the NO setting (up to 10% at 80 ppm) and subtracts gas from the breathing circuit via gas sampling at a nominal flow rate of 0.23 L/min.

  • Page 102: Viasys Infant Flow Cpap System; Cardinal Airlife Ncpap System

    Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System 1. INOmax DS 7. Patient Gas Sample Line with Nafion 2. Heated Delivery Circuit 8. Humidifier 3. Infant Flow System 9. 22F X 15M Adapter 4. Infant Flow Generator 10. Injector Module 5.
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  • Page 104: Viasys Infant Flow Sipap

    Viasys Infant Flow SiPAP • The INOmax DS adds NO/N gas flow to the breathing circuit flow in proportion to the NO setting (up to 10% at 80 ppm) and subtracts gas from the breathing circuit via gas sampling at a nominal flow rate of 0.23 L/min.
  • Page 105 Viasys Infant Flow SiPAP 8. Heated Delivery Circuit 1. INOmax DS 9. Humidifier 2. Abdominal Respiratory Sensor 10. 22F X 15M Adapter 3. Transducer Interface 11. Injector Module 4. Infant Flow SiPAP 12. Injector Module Electrical Cable 5. Infant Flow Generator 13.
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  • Page 107: 4/ Transport

    4/ Transport Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 108 4/ Transport Part No. 20717 Rev-01 2014-07...

  • Page 109: Transport Options

    4/ Transport • It is recommended that a second (backup) transport regulator cap assembly is available Caution: during all transports. • It is recommended that a second (backup) cylinder of INOMAX is available during all transports. Transport Options A. When moving the INOmax DS as a unit (cart and cylinders), (see Section A below).

  • Page 110: Intrahospital Transport (Within The Hospital) When Removing The Inomax Ds Ir And Inoblender From The Cart

    B. Intrahospital transport (within the hospital) when removing the INOmax DS and INOblender from the cart. Check the INOMAX drug cylinders for the correct product identity, cylinder concentration, and expiration date. 1. Connect the high pressure transport regulator/cap assembly to the INOMAX transport cylinder, and tighten the fitting to the INOMAX cylinder.
  • Page 111 7. Open INOMAX transport cylinder valve. 8a. Immediately remove “88” INOMAX cylinder regulator hose, and close cylinder valve. 8b. Depressurize the "88" INOMAX cylinder regulator hose by pressing in the purge port. 9a. Disconnect the cart infrared (IR) cable. 9b. Connect the IR cable from the transport regulator cap assembly to the back of the INOmax DS IR Cable to the...
  • Page 112 10. Loosen clamp assembly knob on the back of the INOmax DS and remove the INOmax DS from the cart. 11. Loosen clamp assembly knob on the back of the INOblender and remove the INOblender from the cart. 12. Place both devices on the transport device and secure. 13.
  • Page 113 Once the devices are secure on the cart: 17a. Open/close “88” INOMAX cylinder, then depressurize the regulator hose by pressing the regulator hose into the purge port. 17b. Open the "88" INOMAX cylinder valve and insert the regulator hose into available INOMAX gas inlet.

  • Page 114: When Using The Inoblender As A Stand-Alone Device

    C. When using the INOblender as a stand-alone device. Read the INOblender Operation Manual PN 20732 before using the INOblender. Important: Follow instructions and obey all Warnings and Cautions. Typically the INOblender receives INOMAX from the INOmax DS (INOMAX cylinder supplies both devices;...
  • Page 115 4. Verify INOMAX cylinder valve is open. 5. Verify cylinder has at least 500 psig (replace if 200 psig or less)." Adjust Settings 6. Turn the INOblender setting dial to the desired concentration (5 to 80 ppm for an 800 ppm cylinder). 7.

  • Page 116: Inoblender Test Using The Inomax Ds Ir To Analyze Output

    INOblender Test Using the INOmax DS to Analyze Output • The purge procedure must be followed to help ensure NO is purged from the WARNING: system before the manual resuscitator bag is connected to the patient. • The manual bag should be squeezed repeatedly during use to avoid NO building up in the bag.
  • Page 117 • Confirm INOblender inlet hose is Note: connected to the INOMAX regulator hose and the Quick-Connect cover is in place. • Confirm 50 psig oxygen supply hose is connected to O inlet fitting on back of INOblender. 40 ppm 10 L/min 1.

  • Page 118: Inoblender Stand-Alone Pre-Use Checkout

    INOblender Stand-Alone Pre-use Checkout Caution: To help ensure proper operation, complete the pre-use checkout prior to each use. High-Pressure Leak Test 1. Make sure NO dose setting dial is turned to zero and flow meter is OFF. 2. Open and then close the INOMAX cylinder valve.

  • Page 119: Interhospital Transport (Between Hospitals) When Using A Separate Inomax Ds Ir And

    D. InterHospital Transport (Between Hospitals) when using a separate INOmax DS and INOblender for transport • If the INOmax DS or INOblender is to be used in a transport vehicle, they WARNING: should be affixed to the transport mounting post (part number 10009) which is part of the transport mounting bracket assembly (part number 50041).

  • Page 120: Duration Chart

    Duration Chart INOMAX Cylinder D-Size For an D-Size 800 ppm Cylinder Concentration* (typically used in transport) (Illustrative Only) FLOW 5 L/min 10 L/min 20 L/min 40 L/min 7.0 Days 3.5 Days 1.8 Days 21 Hours 3.5 Days 1.7 Days 21 Hours 10.5 Hours 1.7 Days 20.7 Hours 10.3 Hours 5.2 Hours 20 Hours...

  • Page 121: Transport Regulator/Cap Assembly Application

    Transport Regulator/Cap Assembly Application Before leaving the bedside (intrahospital transport) or hospital (interhospital transport), check Note: the INOMAX cylinder for the correct product identity labels, cylinder concentration and expiration date. Verify cylinder has at least 500 psig (replace if 200 psig or less), and tighten the fitting to the INOMAX cylinder.
  • Page 122 3. Connect the infrared cable from the transport regulator/cap assembly to the back of the INOmax DS (see Figure 4-4). Notice that the connector clicks to indicate Note: that it is latched in place. Do not attempt to connect the transport regulator cap assembly electrical plug to the INOblender outlet port.
  • Page 123 Final Set-up Diagram The following diagram (see Figure 4-9) and photo illustrates all of the components connected. Figure 4-9 Communication will take place between the INOmax DS and the INOmeter after the boot up phase of the INOmax DS is complete. Loss of communication WARNING: between the INOmax DS...

  • Page 124: Connection To A Dual-Limb Transport Ventilator Circuit

    Connection to a Dual-Limb Transport Ventilator Circuit 1. Patient Wye 8. 22M/15F X 22M/15F Adapter 2. Expiratory Breathing Circuit Hose 9. Injector Module Electrical Cable 3. Patient Gas Sample Line with Nafion 10. NO/N Injector Tube 4. Ventilator Expiratory Valve 11.

  • Page 125: Connection To A Single-Limb Transport Ventilator Circuit

    Connection to a Single-Limb Transport Ventilator Circuit 8. 22M/15F X 22M/15F Adapter 1. PEEP Valve 9. Injector Module Electrical Cable 2. Patient Wye 3. Circuit Hose 10. NO/N Injector Tube 4. Patient Gas Sample Line with Nafion 11. Injector Module 5.
  • Page 126 If the INOmax DS is to be used in a transport vehicle, it should be affixed to the WARNING: transport mounting post (part number 10009), see Figure 4-13. Figure 4-13 Universal Mounting Post The universal mounting post has a machined recess with an integrated cap to prevent twisting or Note: accidental release of the device if the mounting clamp assembly becomes loose.

  • Page 127: Cylinder Leak Check

    Cylinder Leak Check If a leak is suspected during the high pressure leak test, the following steps can be taken to check for leaks (see Figure 4-16 for possible cylinder gas leak locations) in the INOMAX regulator or INOMAX cylinder. 1.
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  • Page 129: 5/ Alarms

    5/ Alarms Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 130 5/ Alarms Part No. 20717 Rev-01 2014-07...
  • Page 131 5/ Alarms • Any alarm setpoint adjustments made will not be maintained when system power is cycled. Caution: • Default values will be used following a complete power loss (no AC main power and depleted battery). General alarm information Alarm silencing A listing of alarm messages is provided at the end of Pushing the Alarm Silence button this section.
  • Page 132 User adjustable monitor alarms Do not set upper and lower alarm limits to extreme values, as this could reduce the Caution: effectiveness of the monitoring alarm system. Monitor alarm delay active indicator Monitor alarms for O , NO , and NO will be inactive anytime the Monitor Alarm Delay Active indicator is displayed.

  • Page 133: Alarm History

    Alarm History When an alarm condition has been resolved, the Recent Alarms button alarm message is no longer displayed on the main screen. The recent alarms can be seen by pressing the Recent Alarms button. Figure 5-3 Recent Alarms Button on the Main Screen The Recent Alarms button is present and displayed as a “double-bell”...
  • Page 134 A complete list of all alarms that have occured since the INOmax DS has been turned ON can be viewed by pressing the ALARM HISTORY button on the menu screen (see figure 5-5). Figure 5-5 Menu Screen Priority A yellow dot signifies a low priority alarm, and a red dot signifies a high priority alarm.

  • Page 135: Alarm Help

    Alarm Help • If an alarm occurs, safeguard the patient first before troubleshooting or repair WARNING: procedures. • Use caution when troubleshooting the INOmax DS while in use for a patient. When possible, replace the unit in question, and perform troubleshooting procedure once the unit is removed from the patient.
  • Page 136 • Abrupt discontinuation of INOMAX may lead to worsening oxygenation and WARNING: 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).
  • Page 137 High Priority Alarms Alarm Possible Cause Recommended Action 2. Low NO alarm All of these actions can be performed while delivering INOMAX to the patient: a. The Low NO alarm setting Confirm low NO alarm limit is set appropriately. may be inappropriately set. b.
  • Page 138 High Priority Alarms Alarm Possible Cause Recommended Action 3. High NO alarm All of these actions can be performed while delivering INOMAX to the patient: a. Incomplete System purge. Verify device has been purged. b.The high NO alarm setting Confirm high NO alarm limit is set may be inappropriately set.
  • Page 139 High Priority Alarms Alarm Possible Cause Recommended Action 6. Cylinder Not Detected Communication between All of these actions can be performed while INOMAX cylinder and delivering INOMAX to the patient: INOmax DS has been lost. “Delivery Stopped” will occur 1 hour from point when communication is lost.
  • Page 140 High Priority Alarms Alarm Possible Cause Recommended Action 8. Delivery Failure a. Over-delivery of INOMAX. INOMAX delivery has been interrupted. Manually ventilate patient with the INOblender - (CALCULATED dose is >200% of set dose) AND (CALCULATED dose is turn integrated pneumatic backup delivery ON >...
  • Page 141 High Priority Alarms Alarm Possible Cause Recommended Action 10. Drug Past Expiry Date If dose is set, “Delivery Stopped” will occur two minutes from point when cylinder valve is opened. a. INOMAX cylinder is 1. Close expired cylinder valve. expired. 2.
  • Page 142 High Priority Alarms Alarm Possible Cause Recommended Action 13. Low Battery Alarm. All of these actions can be performed while delivering INOMAX to the patient: a. Battery is running low. Battery will deplete in approximately 30 minutes or less. Confirm main power supply indicator light is illuminated (green).
  • Page 143 Low Priority Alarms Alarm Possible Cause Recommended Action 16. Backup On All of these actions can be performed while delivering INOMAX to the patient: a. The backup mode has been 1. Correct the reason for initiating integrated turned ON. pneumatic backup delivery. 2.
  • Page 144 Low Priority Alarms Alarm Possible Cause Recommended Action 20. Failed O Sensor Delivery of INOMAX continues during this alarm. a. O calibration may have 1. Perform low calibration. drifted. 2. Perform high O calibration. b. There is a leak around the Confirm the O-rings on the sensor and sensor sensors.
  • Page 145 Low Priority Alarms Alarm Possible Cause Recommended Action 24. Water Trap Bottle Full All of these actions can be performed while delivering INOMAX to the patient: a. The water trap bottle on the Empty water trap bottle. side of the INOmax DS full.
  • Page 146 Indicators Indicator Possible Cause Recommended Action 26. Battery Failure a. Device cannot Contact Technical Support. communicate with battery. 27. Low Calibration a. Low calibration in progress. No user action required. A Low Calibration indicator will display in the alarm area of the screen during the low calibration.
  • Page 147 Indicators Indicator Possible Cause Recommended Action 32. NO Delivery Button Inactive a. Device does not recognize 1. Load INOMAX cylinder on to the cart. an INOMAX cylinder, the 2. Remove any obstruction between the dose knob will be greyed INOmeter and the INOmax DS cart cover.
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  • Page 149: 6/ Calibration

    6/ Calibration Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 150 6/ Calibration Part No. 20717 Rev-01 2014-07...
  • Page 151 6/ Calibration INOMAX can be administered during the sensor calibration process. However, WARNING: inspired gases are not monitored and gas monitoring alarms are disabled. During any calibration process, all other alarms remain active while monitoring alarms are disabled. Note: To access the calibration menu: Press the menu button on the main screen to enter the menu screen (second menu level).

  • Page 152: Low Calibration

    Low Calibration The low calibration of the monitor sensors uses room air to calibrate all three sensors at the same time. The system automatically draws in room air from an inlet port behind the water trap, not the sample line. A low calibration is completed automatically when the INOmax DS is turned ON and during the following conditions:...
  • Page 153 3. When the low calibration is successful, a single tone will be heard and the main screen will appear. A two minute Monitor Alarm Delay Active indicator will occur, preventing monitoring alarms from occurring while the measured value stabilizes. All system alarms are still active. If the low calibration was unsuccessful, the INOmax DS will automatically attempt another...

  • Page 154: Oxygen Sensor High Calibration

    Oxygen Sensor High Calibration • When performing a high calibration, make sure to select the correct calibration gas and Caution: confirm the expiration date before using. • Never connect the sample line directly to a high pressure gas source (greater than 150 cmH O);...
  • Page 155 4. After reaching step 5 of the calibration wizard, the calibration will take approximately three minutes, during which a progress bar for the O sensor indicates progress. If the CANCEL button is pressed during Note: the high O calibration process, the calibration will be cancelled and the user will be returned to the high calibration screen.
  • Page 156 If the calibration was unsuccessful, the O progress bar will turn red. • Attempt another calibration. To repeat the O high calibration, press Note: the START CAL button at the bottom of the screen. If the O sensor has failed, the display indicates the failed sensor symbol in the monitoring area of that sensor.

  • Page 157: No Sensor High Calibration

    NO Sensor High Calibration • When performing a high calibration, make sure to select the correct calibration gas and Caution: confirm the expiration date before using. • Never connect the sample line directly to a high pressure gas source (greater than 150 cmH O);...
  • Page 158 6. Open the INOcal cylinder valve (turn counter- clockwise) to flow gas. To INOmax DS 6a. If the pressure is in the red or black zone (0- 25 psig) select another INOcal cylinder. 7. Attach tubing kit to patient gas sample line. Cap off sample tee if patient gas sample Note: line is removed from patient breathing...
  • Page 159 After reaching step 7 of the high calibration wizard, the calibration will take approximately three minutes, during which a progress bar for the sensor indicates progress. If the CANCEL button is pressed during Note: the NO high calibration process, the calibration will be cancelled and the user will be returned to the high calibration screen.
  • Page 160 When using the high calibration wizard, if the BACK button is pressed during the NO high calibration process, the progress bar will turn yellow, signifying a cancelled calibration. • Press the NEXT button to start the high calibration wizard. • Press the START CAL button to start the calibration again.

  • Page 161: No 2 Sensor High Calibration

    Sensor High Calibration • When performing a high calibration, make sure to select the correct calibration gas and Caution: confirm the expiration date before using. • Never connect the sample line directly to a high pressure gas source (greater than 150 cmH O);...
  • Page 162 To INOmax DS 6. Open the INOcal cylinder valve (turn counter- clockwise) to flow gas. 6a. If the pressure is in the red or black zone (0- 25 psig) select another INOcal cylinder. 7. Attach tubing kit to patient gas sample line. Cap off sample tee if patient gas sample Note: line is removed from patient breathing...
  • Page 163 After reaching step 7 of the high calibration wizard, the calibration will take approximately three minutes, during which a progress bar for the sensor indicates progress. If the CANCEL button is pressed during Note: the NO high calibration process, the calibration will be cancelled and the user will be returned to the high calibration screen.
  • Page 164 When using the high calibration wizard, if the BACK button is pressed during the NO high calibration process, the progress bar will turn yellow, signifying a cancelled calibration. • Press the NEXT button to start the high calibration wizard. • Press the START CAL button to start the calibration again.

  • Page 165: 7/ Maintenance

    7/ Maintenance Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 166 7/ Maintenance Part No. 20717 Rev-01 2014-07...
  • Page 167 7/ Maintenance • To help prevent fire, use only lubricants approved for O equipment, such as KRYTOX ® Caution: • Do not use lubricants which contain oil or grease, as they burn or explode in high O concentrations. • Do not sterilize or disinfect with the power connected. Note: The INOmax DS does not contain any user repairable parts.

  • Page 168: Cleaning The Inomax Ds

    Cleaning the INOmax DS • Do not autoclave or gas sterilize the INOmax DS Caution: • Do not clean with the power connected and the INOmax DS turned ON. • Be sure that the INOmax DS is completely dry before using. •...
  • Page 169 PDI Super Sani Cloth by PDI n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.25% n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chlorides 0.25% Isopropyl alcohol 55% Inert ingredients 44.50% Sani Cloth HB by PDI n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chlorides 0.07% n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl...
  • Page 170 Cleaning the INOmeter • Apply cleaning agent to a cloth before application; do not spray directly on the INOmeter. Caution: It is important to prevent pooling and direct contact with electrical connections, which can cause damage over time. • Do not autoclave or gas sterilize the INOmeter. •...
  • Page 171 • If lint fibers remain wrapped around the hot wire sensor after drying, do not use the module. Remove it from service and contact Mallinckrodt Technical Support. Patient circuit adapters, patient gas sample line, injector module tubing and water separator Note: cartridge are single-patient use items.
  • Page 172 Replacing the O , NO and NO Sensors • Handle and dispose of sensors according to facility biohazard policies. WARNING: Do not incinerate. • If changing an NO sensor while delivering NO to a patient, install the NO sensor only when the NO high range calibration screen is displayed, otherwise there is a risk that the system will shut down.

  • Page 173: Replacing The O

    Replacing the O , NO and NO Sensors (cont’d) Replace the sensor cover and tighten the two screws clockwise (see Figure 7-4). Note: Newly Installed Sensor Time to Condition Prior to Calibration and NO 40 minutes 5 hours Insufficient conditioning will result in inaccurate gas readings.

  • Page 174: Replacing The Water Separator Cartridge

    Replacing the Water Separator Cartridge When handling any component of the patient circuit that comes in contact with WARNING: patient’s fluids wear protective safety equipment. The disposable water separator cartridge on the rear of the water trap housing protects the monitoring system from moisture and other contaminants.
  • Page 175 Using the INOMAX Gas Inlet Connector Proper use of the INOMAX inlet connectors is essential for safe and effective delivery of INOMAX. Follow the steps below to ensure the regulator hose is attached correctly. 1. Visually inspect the two inlet connectors and the outlet connector for signs of wear or damage. 2.

  • Page 176: Cylinder Leak Check

    Cylinder Leak Check If a leak is suspected during the high pressure leak test (see section 2/ Pre-Use Checkout; High Pressure Leak Test), the following steps can be taken to check for leaks (see Figure 7-10 for possible cylinder gas leak locations) in the INOMAX regulator or INOMAX cylinder.

  • Page 177: Preventative Maintenance

    Preventative Maintenance Mallinckrodt performs the following maintenance task every year: • Replace O and NO sensors. Mallinckrodt performs the following maintenance task every two years: • Check battery. • Check internal tubing. • Replace sample system tubing and filters. • Replace NO sensor.

  • Page 178: Parts And Accessories

    Parts and Accessories WARNING: Only use parts/accessories designated for use with this system. Parts/Accessories Part Number Calibration Gas Regulator, for NO or NO Calibration Gas 90439 Calibration Tubing Kit 50239 Clamp Assembly 10008 Injector Module 1605-3038-000 Injector Module Cable 90838 INOcal Calibration Gas, NO, 45 ppm BOM-COM-0150 INOcal Calibration Gas, NO...
  • Page 179 Disposables Description Adapter 15M Fits 4.5 mm ID Tubing Adapter, 22F X 15M Adapter, 22M/15F X 22M/15F Adapter, Cuff, 22 mm ID X 22 mm ID Adapter, Gas Sample Tee Adapter, 90 degree Sample Port Bunnell Life Pulse Disposable Adapters Convenience Pack Disk Filter, 0.5 micron Neonatal Tubing, 10 mm (2 pieces)
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  • Page 181: 8/ Product Specifications

    8/ Product Specifications Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 182 8/ Product Specifications Part No. 20717 Rev-01 2014-07...

  • Page 183: Ventilator Compatibility

    8/ Product Specifications • In the United States, the approved patient population for the INOmax DS , as WARNING: specified in the drug labeling for INOMAX (nitric oxide) for inhalation, is limited ® to term and near-term neonates with hypoxic respiratory failure. The INOmax is not intended to be used in other patient populations.
  • Page 184 Ventilators/Breathing Systems validated for use in the United States Nasal Continuous High Flow Pediatric/ High Positive Manufacturer Model Neonatal Transport Anesthesia Nasal Adult Frequency Airway Cannula Pressure (CPAP) Bunnell Life Pulse ● Cardinal AirLife nCPAP System ● Healthcare Carefusion ReVel ●...
  • Page 185 Ventilators/Breathing Systems validated for use in the United States Nasal Continuous High Flow Pediatric/ High Positive Manufacturer Model Neonatal Transport Anesthesia Nasal Adult Frequency Airway Cannula Pressure (CPAP) Infrasonics Infant Star 950 ● Maquet (formerly Servo 300 ● Siemens) Maquet (formerly Servo i ●...
  • Page 186 Ventilators/Breathing Systems validated for use outside the United States Nasal Continuous High Pediatric/ High Positive Flow Manufacturer Model Neonatal Transport Anesthesia Adult Frequency Airway Nasal Pressure Cannula (CPAP) Acutronics Fabian +nCPAP Medical ● Evolution Systems AG Acutronics Medical Fabian HFO ●...
  • Page 187 NO Delivery Set NO Range: 0.1 - 80 ppm ( 800 ppm cylinder ) Set NO Resolution: 0.1 ppm from 0 to 1 ppm 1 ppm from 1 to 40 ppm 2 ppm from 40 to 80 ppm Accuracy @ 20°C: ±...
  • Page 188 Environmental Operating: Transport/Storage: Temperature: 5 to 40°C -20 to + 60°C 15 to 95% RH 15 to 95% RH Humidity: non-condensing non-condensing Ambient 57 to 110 kPa 57 to 110 kPa Pressure: Water Ingress IPX1 Protection: INOMAX Regulator Inlet Pressure: 14 to 155 Bar (200 to 2,248 psig) Outlet Pressure: 1.7 to 2.4 Bar (25 to 35 psig)

  • Page 189: Rs232 Data Output

    RS232 Data Output Enables serial communications for use with hospital electronic health record (EHR) system. Must be connected to the manufacturer-specified third-party hardware (to be determined). • INOmax DS should only be connected to RS-232 ports that have: WARNING: - Four kV input to output isolation - Four kV input to mains isolation and - an internal “reference voltage”...
  • Page 190 Data output includes: • Device information - Model number, device generated identifier, software revision and user generated patient identifier • Monitored values - Monitored O , NO and NO • Settings - Dose setpoint - Alarm setpoints ▪ High O , low O , high NO , high NO and low NO...

  • Page 191: Electromagnetic Compatibility Information

    Electromagnetic Compatibility Information Guidance and Manufacturer’s Declaration – Electromagnetic Emissions INOmax DS system is intended for use in the electromagnetic environment specified below. The user of the INOmax DS system should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment -...
  • Page 192 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity INOmax DS system is intended for use in the electromagnetic environment specified below. The user of the INOmax DS system should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 test level Compliance Level Environment Guidance...
  • Page 193 Guidance and Manufacturer’s declaration - Electromagnetic Immunity INOmax DS system is intended for use in the electromagnetic environment specified below. The user of the INOmax DS system should assure that they are used in such an environment Immunity Test IEC 60601 test level Compliance Electromagnetic environment - guidance level Conducted RF...
  • Page 194 Recommended separation distances between portable and mobile RF communications equipment and the INOmax DS system INOmax DS system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the INOmax DS system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the...

  • Page 195: 9/ Appendix

    9/ Appendix Part No. 20003 Rev - 01 Part No. 20717 Rev-01 2014-07...
  • Page 196 9/ Appendix Part No. 20717 Rev-01 2014-07...

  • Page 197: Manual Pre-Use Checkout

    Self Test Screen Turn ON INOmax DS An INOmax DS splash screen will appear once the device is turned ON followed by a Mallinckrodt test screen (confirm that the speaker sounds). Low calibration automatically starts Note: following the INOmax DS self test.

  • Page 198: Initial Connections

    Initial connections 1. Confirm the water trap bottle and water separator cartridge are in place Connect the patient gas sample line with Nafion to the sample line inlet port on the front of the INOmax DS Check cables and hoses for signs of wear and damage.
  • Page 199 3. Connect the INOmax DS power cord to an emergency-power-backed hospital-grade outlet. The power cord must always be connected to an electrical outlet to maintain a full battery charge. Verify the main power supply indicator light is illuminated (green). This indicates that the power cord is plugged into an electrical outlet.
  • Page 200 6. If using the INOblender with the INOmax DS , connect the INOblender inlet hose to the INOmax DS INOblender outlet and slide the quick-connect cover into place . Connect oxygen supply (wall source or cylinder oxygen, ) hose to O inlet fitting on back of INOblender .

  • Page 201: High Pressure Leak Test

    High Pressure Leak Test • A new INOMAX cylinder and regulator must be purged before use to ensure the WARNING: patient does not receive an excess level of NO • Loss of communication between the INOmax DS and the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery.

  • Page 202: Manual Purge And Alarm Verification

    Manual Purge and Alarm Verification Allow the auto low calibration to complete before Note: completing the manual purge and alarm verification. Assemble connectors and tubing as shown in Figure 9-1 to perform the following three procedures: 1. Verify the INOMAX cylinder valve is closed. 2.

  • Page 203: Integrated Pneumatic Backup Inomax Delivery Test

    Integrated Pneumatic Backup INOMAX Delivery Test 1. Verify that the O flowmeter is set to 10 L/min. 2. Turn the integrated backup INOMAX delivery to ON (250 mL/min.). Verify "Backup ON" alarm occurs. 3. Allow monitored values to stabilize (may take up to 3 minutes) and make sure the NO and readings are within the following ranges: NO = 14-26 ppm...

  • Page 204: Inoblender Test

    INOblender Test • Ensure INOblender inlet hose Note: is connected to the back of the INOmax DS and the Quick-Connect cover is in place. • Ensure oxygen supply hose is connected to O inlet fitting on back of 40 ppm INOblender.
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  • Page 206 Mallinckrodt Manufacturing LLC 6603 Femrite Drive, Madison, WI 53718-6801 USA 877-566-9466 Part No. 20717 Rev-01 2014-07...

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