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Mallinckrodt INOmax DSIR Pocket Manual

Delivery system
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(Delivery System)
Pocket Guide
Pre-Use Procedure
Backup INOMAX
Delivery
®
Transport Regulator/Cap Assembly
Oxygen Dilution Chart
INOMAX Cylinder Duration Chart
Circuit Connection Diagrams
Changing INOMAX Cylinders
High Calibration Connection Diagrams
INOmax DS
Disposable Adapters
IR
For 24 Hour Assistance
Call 1-877-566-9466
Part No. 20728 Rev-01
2012-09

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Summary of Contents for Mallinckrodt INOmax DSIR

  • Page 1 (Delivery System) Pocket Guide Pre-Use Procedure Backup INOMAX Delivery ® Transport Regulator/Cap Assembly Oxygen Dilution Chart INOMAX Cylinder Duration Chart Circuit Connection Diagrams Changing INOMAX Cylinders High Calibration Connection Diagrams INOmax DS Disposable Adapters For 24 Hour Assistance Call 1-877-566-9466 Part No.
  • Page 2 IMPORTANT: This guide is provided as a convenience and for general information only. Do not use this product without clearly and thoroughly understanding the most recent revision of the INOmax DS Operation Manual. The Operation ® Manual is the source for specific, updated information regarding warnings, cautions, checklists, diagrams, and/or instructions contained in this guide.
  • Page 3 – Raised silver data port on the side of the INOmeter. Symbols Infrared Input/Output 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 Part No. 20728 Rev-01 2012-09...

  • Page 4: Table Of Contents

    Contents Pre-Use Checkout ..................5 Backup INOMAX Delivery ...............12 Transport Regulator/Cap Assembly ............14 Oxygen Dilution Chart ................18 INOMAX Cylinder 88-size Duration Chart ..........19 INOMAX Cylinder D-size Duration Chart..........20 Connection to Various Breathing Systems ..........22 A-Plus Medical Babi-Plus Bubble CPAP ........... 23 Bagging Systems While Using the Injector Module ......24 Bunnell Life Pulse High Frequency Ventilator Circuit ......28 Connecting INOmax DS...

  • Page 5: Pre-Use Checkout

    Pre-Use Checkout Pre-Use Checkout Outline Initial Connections High Pressure Leak Test Low Range Calibration Purge and Alarm Verification Backup INOMAX Delivery Test INOmax DS Performance Test INOblender Test Part No. 20728 Rev-01 2012-09...
  • Page 6 Pre-Use Checkout A. Initial Connections 1. Check white plastic tip. 2. Connect high pressure regulator. Part No. 20728 Rev-01 2012-09...
  • Page 7 Pre-Use Checkout 3. Connect the INOMAX regulator hose to one of the INOMAX inlets 4. Connect the INOblender inlet hose to the INOmax DS blender outlet 5. Connect the infrared cable to the back of the INOmax DS 6. Connect the oxygen hose to the INOblender oxygen inlet 7.
  • Page 8 Pre-Use Checkout B. Perform High Pressure Leak Test (Open/Close INOMAX cylinder valve) Wait 30 seconds and ensure no pressure drop. Note: Make sure INOmax backup and INOblender are OFF. C. Perform Low Range Calibration (second menu level) Note: Once the calibration is completed (bars turn green and single tone sounds) press the menu button twice to return to the main screen.
  • Page 9 Pre-Use Checkout 1. O Flowmeter (Connected to wall/tank) 6. 300mm of 22mm Hose 2. O Tubing 7. Gas Sample Tee 3. 15M x 4.5mm Adapter 8. Patient Gas Sample Line 4. 22M / 15F x 22M / 15F Adapter with Nafion 5.
  • Page 10 Pre-Use Checkout E. Perform Backup INOMAX Delivery Test 1. Turn backup delivery ON. 2. Verify “Backup ON” alarm activates. 3. Verify values. NO = 14-26 ppm = <1.0 ppm 4. Turn backup delivery OFF. F. Complete INOmax DS Performance Test 1.
  • Page 11 Pre-Use Checkout G. Perform INOblender Test Note: Ensure INOblender inlet hose is connected to the back of and the quick-connect cover is in place. the INOmax DS 1. Remove the Pre-Use set- up oxygen tubing from the oxygen flowmeter and connect it to the front of the INOblender.

  • Page 12: Backup Inomax Delivery

    Backup INOMAX Delivery WARNING: When the backup NO delivery mode is used, a flow of at least 5.0 L/min should be present in the ventilator circuit to avoid INOMAX concentrations greater than 40 ppm. The backup is intended for short term use when the electronic delivery system fails until a replacement NO delivery can be brought to the bedside.
  • Page 13 Backup INOMAX Delivery The backup delivery provides a fixed flow of 250 mL/min of INOMAX directly into the ventilator circuit through the Injector Module. Backup NO delivery is completely pneumatic and is not reliant on the operation of the main system. Backup delivery mode OFF. Backup delivery mode ON (with a Low Priority alarm). Part No.

  • Page 14: Transport Regulator/Cap Assembly

    Transport Regulator/ Cap Assembly Transport Regulator/Cap Assembly WARNING: • A new INOMAX cylinder and regulator must be purged before use to ensure the patient does not receive greater than 1.0 ppm 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 15 Transport Regulator/ Cap Assembly Step Two Connect the INOMAX regulator hose to one of the INOMAX inlets on the back of the INOmax (see Figure 3). Figure 3 Step Three Connect the Infrared cable from the Transport Regulator/Cap Assembly to the back of the INOmax (see Figure 4).
  • Page 16 Transport Regulator/ Cap Assembly Step Four Place the Cap Assembly over the INOmeter (see Figure 5). Note: Be sure to align the keyway inside the Cap Assembly with the iButton on the INOmeter (see Figure 5 and 6). iButton The electrical cord exits the cap directly above the...

  • Page 17: Additional Information

    Transport Regulator/ Cap Assembly Final Set-up Diagram The following diagram and photo illustrates all of the components connected. Additional Information Communication will take place between the INOmax DS and the INOmeter after the boot up phase of the INOmax DS is complete.

  • Page 18: 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 19: Inomax Cylinder 88-Size Duration Chart

    Duration Chart (88-size) INOMAX Cylinder 88-Size For an 88-Size 800 ppm Cylinder Concentration* (Illustrative Only) FLOW L/min L/min L/min L/min 43.3 21.7 10.8 Days Days Days Days 21.5 10.7 Days Days Days Days 10.6 Days Days Days Hours Days Days Hours Hours Days...

  • Page 20: Inomax Cylinder D-Size Duration Chart

    Duration Chart (D-size) INOMAX Cylinder D-Size For a D-Size 800 ppm Cylinder Concentration* (Illustrative Only) FLOW L/min L/min L/min L/min Days Days Hours Hours Days Hours Hours Hours Hours Hours Hours Hours Hours Hours Hours Hours Hours Hours Hours Hour Typically used in transport This chart is representative of a range of doses available on the INOmax DS...
  • Page 21 Duration Chart (D-size) (Intentionally left blank) Part No. 20728 Rev-01 2012-09...

  • Page 22: Connection To Various Breathing Systems

    Circuit Connection Diagrams Proper use of these products depends on careful reading and understanding of labeling and instructions. Please refer to the INOmax DS and INOblender operation manuals for guidance. Also refer to the specific breathing device operation manual or instructions for use. INOmax DS Warnings: • INOmax DS subtracts gas from the breathing circuit via the gas sampling system at 230 mL per minute;...

  • Page 23: A-Plus Medical Babi-Plus Bubble Cpap

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

  • Page 24: Bagging Systems While Using The Injector Module

    Circuit Connection Diagrams Connection to Bagging Systems While Using the Injector Module WARNING: To minimize the delivered concentration of NO2, the following steps should be taken for use with the manual resuscitator bags: • Use the smallest bag adequate to deliver the desired tidal volume.
  • Page 25 Circuit Connection Diagrams 1. O Flowmeter (wall outlet or cylinder) 2. O Tubing 3. 15M X 4.5mm Adapter 4. 22M/15F X 22M/15F Adapter 5. Injector Module 6. 15M X 4.5mm Adapter 7. O Tubing 8. O Tubing Sample Tee 9. Patient Gas Sample Line with Nafion 10.
  • Page 26 • The monitoring system within the INOmax DSIR will not detect generation of within the hyperinflation bag or self-inflating bag devices and the alarms...
  • Page 27 Circuit Connection Diagrams Connection to Bagging Systems While Using the Injector Module 1. O Flowmeter 7. Hyper-Inflation Bag 2. Injector Module Electrical Cable 8. Pressure Gauge 3. NO/N Injector Tube 9. 15M X 4.5mm Adapter 4. Patient Gas Sample Line with 10.

  • Page 28: Bunnell Life Pulse High Frequency Ventilator Circuit

    Circuit Connection Diagrams Connection to a Bunnell Life Pulse High Frequency Ventilator Circuit WARNING: • The INOmax DS backup mode (250 mL/min.) should not be used with the Bunnell Life Pulse as ventilator flow rates are normally below the recommended ventilator flows. •...
  • Page 29 Circuit Connection Diagrams Connection to a Bunnell Life Pulse High Frequency Ventilator Circuit (cont.) 1. INOmax DS 6. Life Port Adapter 2. Bunnell Life Pulse 7. Endotracheal Tube 3. Humidifier 8. Sample Tee 4. Humidifier 9. Patient Box 5. Conventional Ventilator 10.

  • Page 30: Pulse Circuit

    Circuit Connection Diagrams Connecting INOmax DS Sample Tee to the Bunnell Life Pulse Circuit 1. From Patient Box 3. Insert Sample Tee 2. Cut Green tube at midpoint (approximately 6 in. from the Life Port Adapter) 4. Life Port Adapter Connecting INOmax DS Injector Module to the Bunnell Life Pulse Circuit...

  • Page 31: Circle Anesthesia System

    Circuit Connection Diagrams Connection to a Circle Anesthesia System 1. Patient Gas Sample Line with 8. Absorber Inspiratory Port Nafion 9. Absorber 2. Patient Gas Sample Line 10. Injector Module Input Connection a. Injector Module Input End 3. INOmax DS b.

  • Page 32: Fisher & Paykel Healthcare Bubble Cpap

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

  • Page 33: Fisher & Paykel Healthcare Infant Circuit Nasal Cannula

    Circuit Connection Diagrams Connection to the Fisher & Paykel Infant Circuit Nasal Cannula 9. Injector Module Electrical Cable 1. Patient Gas Sample Line with Nafion 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 34: Fisher & Paykel Healthcare Optiflow Breathing Circuit

    Circuit Connection Diagrams Connection to the Fisher & Paykel Optiflow Breathing Circuit 1. Patient Gas Sample Line with Nafion 10. Breathing Circuit 2. INOmax DS 11. Temperature Probe 12. Gas Sample Tee 3. Oxygen Source 4. Breathing Circuit Hose 13. 22M/15F X 22M/15F Adapter 5. Injector Module 14.

  • Page 35: Hamilton Arabella Nasal Cpap

    Circuit Connection Diagrams Connection to the Hamilton Arabella Nasal CPAP 1. Arabella 7. 22F X 15M Adapter 8. Humidifier 2. Patient Gas Sample Line with Nafion 3. INOmax DS 9. Heated Delivery Circuit 4. NO/N Injector Tube 10. Universal Generator 5. Injector Module Electrical Cable 11.

  • Page 36: Icu Ventilator Circuit

    Circuit Connection Diagrams ICU Ventilator Circuit 1. Patient Wye 2. Ventilator 3. Ventilator Expiratory Port 4. Ventilator Inspiratory Port 5. Patient Gas Sample Line Input Connection 6. INOmax DS 7. NO/N Injector Tube Front Panel Connection a. Injector Module 8. Injector Module Electrical Cable Front b.

  • Page 37: Sensormedics 3100A/B High Frequency Oscillatory Ventilator With A Filtered Circuit

    Circuit Connection Diagrams Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit a. Injector Module b. 22F Inlet c. 22M / 15F Outlet 10. Paw Limit Valve Control 1. Sensormedics 3100A/B Ventilator 11. Filter 2. Ventilator Outlet 12. Humidifier Inlet 3.

  • Page 38: Sensormedics 3100A/B High Frequency Oscillatory Ventilator With A Rigid Or Flexible Circuit

    Circuit Connection Diagrams Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit a. Injector Module b. 22F Inlet c. 22M / 15F Outlet 9. Humidifier Inlet 1. Sensormedics 3100A/B Ventilator 10. Humidifier Outlet 2. Ventilator Outlet 11. Patient Gas Sample 3.

  • Page 39: Spontaneous Breathing Patient On A Mask Circuit

    Circuit Connection Diagrams Connection to Spontaneous Breathing Patient on a Mask Circuit 1. O Tubing 9. 22M/15F X 22M/15F Adapter 10. One-Way Valve 2. 15M X 4.5mm Adapter 3. 22M/15F X 22M/15F Adapter 11. Sealed Face Mask 4. Breathing Circuit Tee 12.

  • Page 40: Spontaneous Breathing Patient On A Nasal Cannula

    Circuit Connection Diagrams Connection to 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 2 L/min. WARNING: Do not use the INOmax DS backup mode with flow rates less than 5 L/min.

  • Page 41: Teleflex Medical Comfort Flo Humidification System

    Circuit Connection Diagrams Connection to the Teleflex Medical Comfort Flo Humidification System 10. Temperature Probe Connector 11. Second Temperature Probe Connector 12. Comfort Flo Cannula 13. Injector Module Electrical Cable 14. NO/N Injector Tube 15. ConchaTherm Heated Humidifier 5. Air/Oxygen Blender or 1.

  • Page 42: Transport Ventilator Circuit

    Circuit Connection Diagrams Transport Ventilator Diagram 1. Patient Wye 7. Ventilator Inspiratory Port 2. Expiratory Breathing Circuit Hose 8. 22M/15F X 22M/15F Adapter 3. Patient Gas Sample Line with 9. Injector Module Electrical Cable Nafion 10. NO/N Injector Tube 4. Ventilator Expiratory Valve 11.
  • Page 43 Circuit Connection Diagrams WARNING: If the INOmax DS is to be used in a transport vehicle, it should be affixed to the transport mounting post part number 10009 (see Figure 10). Figure 10 Figure 11 Caution: When using the Transport Regulator/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 the back of the INOmax DS...
  • Page 44 Circuit Connection Diagrams Single-Limb Transport Ventilator Diagram 1. PEEP/Exhalation Valve 7. Ventilator Inspiratory Port 2. Patient Wye 8. 22M/15F X 22M/15F Adapter 3. Circuit Hose 9. Injector Module Electrical Cable 4. Patient Gas Sample Line 10. NO/N Injector Tube with Nafion 11.
  • Page 45 Circuit Connection Diagrams WARNING: If the INOmax DS is to be used in a transport vehicle, it should be affixed to the transport mounting post part number 10009 (see Figure 10). Figure 10 Figure 11 Caution: When using the Transport Regulator/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 the back of the INOmax DS...

  • Page 46: 10. Vapotherm 2000I

    Circuit Connection Diagrams Connection to the Vapotherm 2000i 1. INOmax DS 9. 15M x 4.5mm Adapter 10. Vapotherm 2000i 2. O Flowmeter 3. O Tubing 11. Patient Delivery Tube 4. 15M x 4.5mm Adapter 12. O Tubing Sample Tee 13. Patient Cannula 5.

  • Page 47: Vapotherm Precision Flow

    • Follow all manufacturer instructions for connection to the Vapotherm Precision Flow. 1. Patient Gas Sample Line with Nafion 2. INOmax DSIR 3. Precision Flow Unit 4. Injector Module 5. Patient Delivery Tube 6. Oxygen Tubing Sample Tee 7. Patient Cannula 8.

  • Page 48: Viasys Infant Flow Cpap System; Cardinal Airlife Ncpap System

    Circuit Connection Diagrams Connection to the Viasys Infant Flow CPAP System; Cardinal AirLife nCPAP System 1. INOmax DS 7. Patient Gas Sample Line 2. Heated Delivery Circuit with Nafion 8. Humidifier 3. Infant Flow System; Cardinal AirLife nCPAP System 9. 22F X 15M Adapter 4.

  • Page 49: Viasys Infant Flow Sipap

    Circuit Connection Diagrams Connection to the Viasys Infant Flow SiPAP 1. INOmax DS 8. Heated Delivery Circuit 2. Abdominal Respiratory Sensor 9. Humidifier 3. Transducer Interface 10. 22F X 15M Adapter 4. Infant Flow SiPAP 11. Injector Module 5. Infant Flow Generator 12.

  • Page 50: Inoblender Circuit Connection

    INOblender Circuit Connection Diagram INOblender Warnings: • The purge procedure must be followed to help ensure NO purged from the pressure regulator, INOblender and hoses before the manual resuscitator bag or nasal cannula is connected to the patient. The manual bag should be squeezed continuously during use to avoid NO building up in the bag.

  • Page 51: Fisher & Paykel Healthcare Neopuff Resuscitator

    INOblender Circuit Connection Diagram INOblender Connection to the Fisher & Paykel Neopuff Resuscitator 1. Oxygen Source 2. Neopuff 3. T-Piece Circuit (with Duckbill Port) 4. Patient Connection 5. Temperature Probe 6. Humidified Resuscitation System Circuit 7. Humidifier 8. Oxygen Tubing 9. INOblender 10. INOMAX Inlet Part No.

  • Page 52: Changing Inomax Cylinders

    Changing INOMAX Cylinders Changing INOMAX Cylinders WARNING: • A new INOMAX cylinder and regulator must be purged before use to ensure the patient does not receive greater than 1.0 ppm of NO • Loss of communication between the INOmax DS the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery.
  • Page 53 Changing INOMAX Cylinders B. Perform high pressure leak test. C. Purge the high pressure hose. D. Connect the pressure hose. Part No. 20728 Rev-01 2012-09...
  • Page 54 Changing INOMAX Cylinders Changing INOMAX Cylinders (cont.) E. Open the cylinder valve (this may activate the “Two Cylinders Open” alarm until the empty cylinder valve is closed). Note: If using the INOmax DS Transport Regulator/Cap Assembly, transfer the cap from the exhausted INOMAX cylinder to the new INOMAX cylinder at this time;...
  • Page 55 Changing INOMAX Cylinders (Intentionally left blank) Part No. 20728 Rev-01 2012-09...

  • Page 56: High Calibration Connection Diagrams

    High Calibration Connection Diagrams Connection Diagram for NO and NO High Range Calibration 1. Calibration Gas Cylinder Pressure Gauge 2. Sample Line Connection 3. One-way Valve 4. Vent to Atmosphere or Scavenge - Do Not Occlude 5. Cylinder ON/OFF Control 6.
  • Page 57 High Calibration Connection Diagrams Connection Diagram for O High Range Calibration 1. 100% O Source 2. O Tubing 3. 15M x 4.5mm I.D. Adapter 4. Gas Sample Tee 5. Patient Gas Sample Line with Nafion Part No. 20728 Rev-01 2012-09...

  • Page 58: Inomax Ds Ir Disposable Adapters

    INOmax DS Disposable Adapters INOmax DS Patient Circuit Disposables (Note: Graphics not actual size) Adapter, Adapter, 22F X 15M 15M Fits 4.5mm ID Tubing Adapter, 22M/15F X 22M/15F Adapter, Cuff, 22mm ID X 22mm ID Adapter, Gas Sample Tee Adapter, 90 degree Sample Port Bunnell Life Pulse Disposable Disk Filter, 0.5 micron Adapters Convenience Pack...
  • Page 59 INOmax DS Disposable Adapters One-way Valve, 22F X 22M Patient Gas Sample Line with Nafion Pediatric Extension, Sample Tee, O Tubing 15 mm (6 inches) Sensormedics 3100A/B Water Separator Cartridge Filtered Circuit Disposable Adapters Convenience Pack Part No. 20728 Rev-01 2012-09...
  • Page 60 Mallinckrodt Manufacturing LLC 6603 Femrite Drive, Madison, WI 53718-6801 USA 877-566-9466 Part No. 20728 Rev-01 2012-09...

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