Operation Manual - INOMAX

1 Part No. 20003 Rev - 01 Part No. 20717 Rev-012014-07 Operation Manual (800 ppm INOMAX (nitric oxide) for inhalation)Series 3 softwarePart No. 20717 Rev-012014-07 User ResponsibilityThis Product will perform in conformity with the description contained in this operating Manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked prior to use following the Pre-Use Checkout procedure described in section two.

2 A defective Product should not be used. Parts that are broken, missing, visibly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, the manufacturer recommends that a telephone request for service advice be made to the local distributor. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer or local distributor. The Product must not be altered.

3 The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Mallinckrodt : Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the and Canada, check local laws for any restrictions that may apply. Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local products have unit serial numbers with coded logic which indicate the year of manufacture and a sequential unit number for license is conveyed, either expressed or implied, with the purchase or usage hereof under any patent or patent application covering this product.

4 See Patents and any respective foreign equivalents Source SoftwareA CD-ROM is available upon request containing the full source code to the open source software used within this of this software are copyright 1996-2002 The FreeType Project ( ). All rights fonts Baekmuk Batang, Baekmuk Dotum, Baekmuk Gulim, and Baekmuk Headline are registered trademarks owned by Kim , 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.

5 2016 MallinckrodtImportant:Before using the INOMAX DSIR, read through this through the manuals for the ventilator, humidifier and any other accessory items used. Follow the Manual instructions and obey the Warnings and this Manual readily available to answer 20051234 The first four numeric digits indicate the year of product manufacture, and the next four digits are the sequential unit number 10007 INOMAX DSIR part numberPart No. 20717 Rev-012014-07iContents1/ General Information ..1-1 Indications for 1-1 Introduction to this Manual .

6 1-2 INOmeter Operation ..1-18 Theory of Operation ..1-22 Environmental Effects ..1-262/ 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 ..2-7 Performance Test ..2-8 INOblender Test ..2-9 Depressurizing the Regulator Supply Line ..2-103/ Patient Application ..3-1 INOblender Operation ..3-4 INOblender Used as a Stand-Alone Device ..3-5 INOblender use with the NeoPuff ..3-6 Integrated Pneumatic Backup NO Delivery.

7 3-7 Changing INOMAX Cylinders and Purging the Regulator Assembly ..3-10 Oxygen Dilution Chart ..3-13 Duration Chart INOMAX Cylinder 88-Size ..3-14 Duration Chart INOMAX Cylinder D-Size ..3-15 Monitoring the Environment ..3-19 Entering Patient Information ..3-20 Connection to Various Breathing Systems ..3-24 Acutronics Medical Systems AG Fabian +nCPAP Evolution ..3-25 Acutronics Medical Systems AG Fabian HFO ..3-26A-Plus Medical Babi-Plus Bubble CPAP Circuit ..3-27 Bagging Systems While Using the Injector Module.

8 3-28 Bunnell Life Pulse High Frequency Ventilator Circuit ..3-32 Connecting INOMAX DSIR Sample Tee to the Bunnell Life Pulse Circuit ..3-33 Connecting INOMAX DSIR Injector Module to the Bunnell Life Pulse Circuit ..3-33 Circle Anesthesia System ..3-34Dr ger Babylog VN500/Infinity Acute Care System and Heinen & L wenstein Leoni-plus Ventilator ..3-36 Fisher & Paykel Healthcare Bubble CPAP ..3-37 Fisher & Paykel Healthcare Infant Circuit Nasal Cannula ..3-38 Fisher & Paykel Healthcare Optiflow Breathing Circuit.

9 3-39 Hamilton Arabella Nasal CPAP ..3-40 ICU Ventilator Circuit ..3-41 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit ..3-42 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit . 3-43 SLE Life Support SLE5000 ..3-44 Spontaneous Breathing Patient on a Mask Circuit ..3-45 Spontaneous Breathing Patient on a Nasal Cannula ..3-46 Teleflex Medical Comfort Flo Humidification System ..3-47 Vapotherm 2000i ..3-48 Vapotherm Precision Flow.

10 3-49 Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System ..3-50 Viasys Infant Flow SiPAP ..3-52 Part No. 20717 Rev-012014-07ii4/ Transport ..4-1 Transport Options ..4-1A. Intrahospital transport (within the hospital) when moving the INOMAX DSIR as a unit (cart and cylinders) ..4-1B. Intrahospital transport (within the hospital) when removing the INOMAX DSIR and INOblender from the cart..4-2C. When using the INOblender as a stand-alone device..4-6 INOblender Test Using the INOMAX DSIR to Analyze Output.