Mallinckrodt INOmax DSIR Pocket Manual

Mallinckrodt INOmax DSIR Pocket Manual

Delivery system, series 3 software
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(Delivery System)
Pocket Guide
Series 3 software
Automated Pre-Use Procedure
Integrated Pneumatic 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. 20751 Rev-01
2014-08

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Summary of Contents for Mallinckrodt INOmax DSIR

  • Page 1 (Delivery System) Pocket Guide Series 3 software Automated Pre-Use Procedure Integrated Pneumatic 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 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. 20751 Rev-01 2014-08...
  • Page 4: Table Of Contents

    Contents Automated Pre-Use Checkout ..............5 Integrated Pneumatic Backup INOMAX Delivery .........8 Transport Regulator/Cap Assembly ............10 Oxygen Dilution Chart ................14 INOMAX Cylinder 88-size Duration Chart ..........15 INOMAX Cylinder D-size Duration Chart............16 Connection to Various Breathing Systems ..........17 Acutronics Medical Systems AG Fabian +nCPAP Evolution ....18 Acutronics Medical Systems AG Fabian HFO ........
  • Page 5: Automated Pre-Use Checkout

    Pre-Use Checkout Automated Pre-Use Checkout 1. Turn INOmax DS ON, verify speaker function. Note: A low range calibration automatically starts following the self test. A Pre-Use wizard will be displayed on the main screen, which will provide step-by-step instructions to complete the automated Pre-Use procedure.
  • Page 6 Pre-Use Checkout Part No. 20751 Rev-01 2014-08...
  • Page 7 Pre-Use Checkout (Intentionally left blank) Part No. 20751 Rev-01 2014-08...
  • Page 8: Integrated Pneumatic Backup Inomax Delivery

    Integrated Pneumatic Backup INOMAX Delivery Note: Use the integrated pneumatic backup function only for a short time, until a replacement delivery system can be obtained. The INOblender can also be used as a backup. If the main delivery system fails, the INOmax DS has an integrated pneumatic backup delivery function that allows the patient to remain connected to the ventilator.
  • Page 9 Integrated Pneumatic Backup INOMAX Delivery The main screen: · Indicates that backup delivery is on and that the set dose is turned off. · Displays the estimated dose that the patient should be receiving, based on the ventilator flow. · Displays the NO concentration table Note: If the injector module is not functioning, the estimated backup dose graphic will be inactive.
  • Page 10: 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 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 11 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 12 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 13 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 14: 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 15: 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 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...
  • Page 16: Inomax Cylinder D-Size Duration Chart

    Duration Chart (D-size) INOMAX Cylinder D-Size 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 10 Hours 5 Hours 2.5 Hours...
  • Page 17: 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 18: Acutronics Medical Systems Ag Fabian +Ncpap Evolution

    Circuit Connection Diagrams Acutronics Medical Systems AG Fabian +nCPAP Evolution (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 19: Acutronics Medical Systems Ag Fabian Hfo

    Circuit Connection Diagrams Acutronics Medical Systems AG Fabian HFO (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 4.
  • Page 20: A-Plus Medical Babi-Plus Bubble Cpap

    Circuit Connection Diagrams A-Plus Medical Babi-Plus Bubble CPAP 1. Oxygen Source 9. Tee Adapter 2. Oxygen Tubing 10. Breathing Circuit 3. Pressure Relief Manifold 11. Humidifier 4. Injector Module 12. NO/N Injector Tube 5. Temperature Probe 13. Injector Module Electrical Cable 6.
  • Page 21 Circuit Connection Diagrams (Intentionally left blank) Part No. 20751 Rev-01 2014-08...
  • Page 22: Bagging Systems While Using The Injector Module

    Circuit Connection Diagrams 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 23 Circuit Connection Diagrams 1. O 2 Flowmeter (wall outlet or cylinder) 2. O 2 Tubing 3. 15M X 4.5 mm Adapter 4. 22M/15F X 22M/15F Adapter 5. Injector Module 6. 15M X 4.5 mm Adapter 7. O 2 Tubing 8. O 2 Tubing Sample Tee 9. Patient Gas Sample Line with Nafion 10.
  • Page 24 • 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 25 Circuit Connection Diagrams Bagging Systems While Using the Injector Module 1. O Flowmeter 8. Pressure Gauge 2. Injector Module Electrical Cable 9. 15M X 4.5mm Adapter 3. NO/N Injector Tube 10. Injector Module 4. Patient Gas Sample Line with Nafion 11. 22M/15F X 22M/15F Adapter 5.
  • Page 26: Bunnell Life Pulse High Frequency Ventilator Circuit

    Circuit Connection Diagrams 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. • Place the Life Pulse in Standby prior to suctioning the patient to avoid NO delivery transiently exceeding the set dose by up to 30 ppm.
  • Page 27 Circuit Connection Diagrams Bunnell Life Pulse High Frequency Ventilator Circuit (cont.) 1. INOmax DS 8. Sample Tee 2. Bunnell Life Pulse 9. Patient Box 3. Humidifier 10. One-Way Valve 4. Humidifier 11. Injector Module 5. Conventional Ventilator 12. NO/N Injector Tube 6.
  • Page 28: Connecting Inomax Ds

    Circuit Connection Diagrams 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 29: Circle Anesthesia System

    Circuit Connection Diagrams 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. Injector Module Output End 4.
  • Page 30: Dräger Babylog Vn500/Infinity Acute Care System And Heinen & Löwenstein Leoni-Plus Ventilator

    Circuit Connection Diagrams Dräger Babylog VN500/Infinity Acute Care System and Heinen & Löwenstein Leoni-plus Ventilator (validated for use outside of the United States) 1. Patient wye 9. Injector Module 2. Dräger Babylog VN500 / Leoni-plus Ventilator 10. One-Way Valve 3. Ventilator Expiratory Port 11. Humidifier Inlet 4.
  • Page 31: Fisher & Paykel Healthcare Bubble Cpap

    Circuit Connection Diagrams Fisher & Paykel Bubble CPAP 1. Oxygen Source 10. F/P Inline Infant Nebulizer Kit 2. Oxygen Tubing (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 32: Fisher & Paykel Healthcare Infant Circuit Nasal Cannula

    Circuit Connection Diagrams Fisher & Paykel 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 33: Fisher & Paykel Healthcare Optiflow Breathing Circuit

    Circuit Connection Diagrams Fisher & Paykel Optiflow Breathing Circuit 1. Patient Gas Sample Line with Nafion 10. Breathing Circuit 2. INOmax DS 11. Temperature Probe 3. Oxygen Source 12. Gas Sample Tee 4. Breathing Circuit Hose 13. 22M/15F X 22M/15F Adapter 5. Injector Module 14. 22 mm ID X 22 mm ID Cuff Adapter 6.
  • Page 34: Hamilton Arabella Nasal Cpap

    Circuit Connection Diagrams Hamilton Arabella Nasal CPAP 1. Arabella 8. Humidifier 2. Patient Gas Sample Line with Nafion 9. Heated Delivery Circuit 3. INOmax DS 10. Temperature Probe 11. Universal Generator 4. NO/N Injector Tube 5. Injector Module Electrical Cable 12. Arabella Sample Tee 6. Injector Module 13.
  • Page 35: Icu Ventilator Circuit

    Circuit Connection Diagrams ICU Ventilator Circuit 1. Patient Wye 2. Patient Gas Sample Line with Nafion 3. Ventilator 4. Ventilator Expiratory Port 5. Ventilator Inspiratory Port 6. Patient Gas Sample Line Input Connection 7. INOmax DS 8. NO/N Injector Tube Front Panel Connection a. Injector Module 9.
  • Page 36: 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 Part No. 20751 Rev-01 2014-08...
  • Page 37 Circuit Connection Diagrams 10. Paw Limit Valve Control 1. Sensormedics 3100A/B Ventilator 11. Filter 2. Ventilator Outlet 12. Humidifier Inlet 3. 22M Adapter 13. Humidifier Outlet 4. Injector Module 14. Bias Flow Tube 5. Injector Module Electrical Cable 15. Patient Gas Sample Line with Nafion Connection 16. 90 Degree Sample Port Adapter 6.
  • 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: Sle Life Support Sle5000

    Circuit Connection Diagrams SLE Life Support SLE5000 Note: • Validated for use outside of the United States. • 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. 22F X 15M Adapter 3.
  • Page 40: Spontaneous Breathing Patient On A Mask Circuit

    Circuit Connection Diagrams Spontaneous Breathing Patient on a Mask Circuit 1. O Tubing 10. One-Way Valve 2. 15M X 4.5 mm Adapter 11. Sealed Face Mask 3. 22M/15F X 22M/15F Adapter 12. One-Way Valve 4. Breathing Circuit Tee 13. Patient Gas Sample Line with Nafion 5.
  • Page 41: Spontaneous Breathing Patient On A Nasal Cannula

    Circuit Connection Diagrams 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. 1.
  • Page 42: Teleflex Medical Comfort Flo Humidification System

    Circuit Connection Diagrams Teleflex Medical Comfort Flo Humidification System 10. Temperature Probe Connector 1. Patient Gas Sample Line with Nafion 11. Second Temperature Probe Connector 2. INOmax DS 12. Comfort Flo Cannula 3. Injector Module 13. Injector Module Electrical Cable 4. System Pressure Relief Valve 14.
  • Page 43: 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 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 Linewith 10. NO/N Injector Tube Nafion 11.
  • Page 45 Circuit Connection Diagrams (Intentionally left blank) Part No. 20751 Rev-01 2014-08...
  • Page 46: Vapotherm 2000I

    Circuit Connection Diagrams 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. 22M/15F x 22M/15F Adapter 6.
  • 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 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 9. 22F X 15M Adapter 3. Infant Flow System 4. Infant Flow Generator 10. Injector Module 5. Sample Tee 11.
  • Page 49: Viasys Infant Flow Sipap

    Circuit Connection Diagrams 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.
  • 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 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 Oxygen Source INOMAX Inlet 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.
  • 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 an excess level 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. 20751 Rev-01 2014-08...
  • 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. 20751 Rev-01 2014-08...
  • Page 56: High Calibration Connection Diagrams

    High Calibration Connection Diagrams Connection Diagram for NO and NO High Range Calibration INOmax DS 6a. If the pressure is in the red or black 1. Cylinder Cap zone (0-25 psig) select another INOcal 2. Regulator Seal cylinder. 3. Regulator 7.
  • Page 57 High Calibration Connection Diagrams Calibration Setup 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. 20751 Rev-01 2014-08...
  • 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. 20751 Rev-01 2014-08...
  • Page 60 Mallinckrodt Manufacturing LLC 6603 Femrite Drive, Madison, WI 53718-6801 USA 1-877-566-9466 Part No. 20751 Rev-01 2014-08...

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