INOmax DSIR 3.0 SW CE Operation Manual (English)

Operation Manual(English)Series 3 softwarePartNo.No.2000320573 RevRev-03Part- 012015-07

User ResponsibilityThis Product will perform in conformity with thedescription contained in this operating manualand accompanying labels and/or inserts, whenassembled, operated, maintained and repairedin accordance with the instructions provided. ThisProduct must be checked prior to use following thePre-Use Checkout procedure described in sectiontwo. A defective Product should not be used. Partsthat are broken, missing, visibly worn, distorted orcontaminated should be replaced immediately.Should such repair or replacement becomenecessary, the manufacturer recommends that atelephone request for service advice be made tothe local distributor. This Product or any of its partsshould not be repaired other than in accordance withwritten instructions provided by the manufacturer orlocal distributor. The Product must not be altered.The user of this Product shall have the soleresponsibility for any malfunction which results fromimproper use, faulty maintenance, improper repair,damage, or alteration by anyone other than INOTherapeutics LLC.Caution: U.S. Federal and Canadian law restrictthis device to sale by or on the order of a licensedmedical practitioner. Outside the U.S.A. andCanada, check local laws for any restrictionsthat may apply.Inhaled Nitric Oxide mixtures must be handledand stored in compliance with federal, state andlocal regulations.INO Therapeutics LLC products have unit serialnumbers with coded logic which indicate the yearof manufacture and a sequential unit number foridentification.Important:Before using the INOmax DSIR, Plus read through this manual.Read through the manuals for the ventilator, humidifier and any other accessory items used. Follow the manualinstructions and obey the Warnings and Cautions.Keep this manual readily available to answer questions.SN 20151234Ref 10023Ref 10085Ref 10086The first four numeric digits indicate the year of product manufacture,and the next 4 digits are the sequential unit number produced.INOmax DSIR, 800 ppm, English - AustraliaINOmax DSIR, 400 ppm, English - EuropeINOmax DSIR, 800 ppm, English - EuropeOpen Source SoftwareA CD-ROM is available upon request containing the full source code to the open source software used within this product.Portions of this software are copyright 1996-2002 The FreeType Project (www.freetype.org). All rights reserved.Korean fonts Baekmuk Batang, Baekmuk Dotum, Baekmuk Gulim, and Baekmuk Headline are registered trademarks owned by Kim Jeong-Hwan. 2015 INO Therapeutics LLCINOMAX , INOmax DSIR Plus, INOmax DS, INOmeter , INOblender , INOcal and INOmax Total Care are registered trademarks ofINO Therapeutics LLC and their respective owners. INO Therapeutics LLC is a wholly-owned subsidiary of a Mallinckrodt company.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. 2015 Mallinckrodt.No license is conveyed, either expressed or implied, with the purchase or usage hereof under any patent or patent application covering thisproduct, including but not limited to U.S. Patent 5,485,827, 5,873,359, 5,558,083 and any respective foreign equivalents thereof.Part No. 20573 Rev-032015-07

Contents1/ G eneral Information . 1-1Indications for Use. 1-1Introduction to this Manual . 1-2INOmeter Operation . 1-18Theory of Operation . 1-22Environmental Effects . 1-262 / Automated P re-Use Checkout . 2 -1Initial connections . 2-2High Pressure Leak Test and Automated Purge . 2-5Integrated Pneumatic Backup INOMAX Delivery Test . 2-7Performance Test . 2-8INOblender Test . 2-9Depressurizing the Regulator Supply Line . 2-103/ P atient Application . 3-1INOblender Operation . 3-4Integrated Pneumatic Backup NO Delivery . 3-5Changing INOMAX Cylinders and Purging the Regulator Assembly . 3-8Oxygen Dilution Chart .3-11Duration Chart INOMAX Cylinder Luxfer 10L-Size . 3-12Duration Chart INOMAX Cylinder Luxfer 2L-Size . 3-13Duration Chart INOMAX Cylinder 88-Size . 3-14Duration Chart INOMAX Cylinder D-Size . 3-15Monitoring the Environment . 3-19Entering Patient Information . 3-20Connection to V arious Breathing Systems . 3-24Acutronic Medical Systems AG F abian nCPAP Evolution . 3-24Acutronic Medical Systems AG F abian HF O. 3-25A-Plus Medical Babi-Plus Bubble CPAP Circuit . 3-26Bagging Systems While Using the Inj ector Module. 3-27Bunnell Life Pulse High F requency V entilator Circuit . 3-30Connecting INOmax DSIR Plus Sample Tee to the Bunnell Life Pulse Circuit . 3-31Connecting INOmax DSIR Plus Inj ector Module to the Bunnell Life Pulse Circuit . 3-31CareF usion Infant F low CPAP System; Cardinal Airlife nCPAP System . 3-32CareF usion Infant F low SiPAP . 3-33Circle Anesthesia System. 3-36r ger abylog500 Infinity Acute are ystem and einenwensteinLeoni-plus V entilator . 3-38Fisher Paykel ealthcare ubble PAP . 3-39Fisher Paykel ealthcare Infant ircuit asal annula . 3-40Fisher Paykel ealthcare pti ow reathing ircuit . 3-41Hamilton Arabella Nasal CPAP . 3-42ICU V entilator Circuit . 3-43INOblender use with the NeoPuff . 3-44Sensormedics 3100A/B High F requency Oscillatory V entilator with a F iltered Circuit . 3-45Sensormedics 3100A/B High F requency Oscillatory V entilator with a Rigid or F lexible Circuit . 3-46SLE Life Support SLE5000 . 3-47Spontaneously Breathing Patient on a Mask Circuit . 3-48Spontaneously Breathing Patient on a Nasal Cannula . 3-49Tele eedical omfort Flo umidification ystem . 3-50V apotherm 2000i . 3-51V apotherm Precision F low. 3-52Part No. 20573 Rev-032015-07i

4 / T ransport . 4 -1Transport Options . 4-1A. Intrahospital transport ( within the hospital) when moving theINOmax DSIR Plus as a unit ( cart and cylinders) . 4-1B. Intrahospital transport ( within the hospital) when removing the INOmax DSIR Plus andINOblender from the cart. . 4-2C. When using the INOblender as a stand-alone device. . 4-6INOblender Test Using the INOmax DSIR Plus to Analyze Output . 4-8INOblender Test. 4-9INOblender Stand-Alone Pre-use Checkout . 4-10D. InterHospital Transport ( Between Hospitals) when using a separate INOmax DSIR Plus andINOblender for transport .4-11Duration Chart INOMAX Cylinder Luxfer 2L-Size . 4-12Duration Chart INOMAX Cylinder D-Size . 4-13Transport Regulator/Cap Assembly Application . 4-14Changing INOMAX Cylinders . 4-17Connection to a Dual-Limb Transport V entilator Circuit . 4-20Connection to a Single-Limb Transport V entilator Circuit . 4-21Cylinder Leak Check . 4-235/ Alarms and T roubleshooting . 5-1Alarm Help.5-11Alarm History . 5-146/ Calibration . 6-1Low Calibration. 6-2Oxygen Sensor High Calibration . 6-4NO Sensor High Calibration . 6-7NO2 Sensor High Calibration.6-117 / Maintenance . 7 -1Cleaning the INOmax DSIR Plus . 7-2Replacing the Water Separator Cartridge . 7-8Replacing the CGA 626 tip on the INOMAX regulator . 7-8Replacing the -ring on the I51 5 IA regulator fitting . 7-9Cylinder Leak Check . 7-10Preventative Maintenance .7-11Parts and Accessories . 7-12/ Product Speci cations. 8-1V entilator Compatibility . 8-2RS 232 Data Output . 8-8Electromagnetic Compatibility Information . 8-109/ Appendix . 9-1Manual Pre-Use Checkout . 9-1iiPart No. 20573 Rev-032015-07

arnings tell the user about dangerous conditions that can cause injury to theoperator or the patient if you do not obey all of the instructions in this manual.W AR NING :Caution:Cautions tell the user about how to properly use the equipment and conditions that couldcause damage to the equipment.Read and obey all warnings and cautions.Note:otes provide clarification or supplemental information.Blue arrow denotes required user action.W AR NING :Changing Cylinders Only use manufacturer supplied drug cylinders, regulators and adapters (seehanging INOMylinders and Purging the egulator ssembly, Section /P atient Application) .High Frequency Oscillatory and Jet Ventilator Circuits Some high fre uency ventilator circuits re uire a one way valve to prevent highNO delivery. Place the unnell ife Pulse in Standby prior to suctioning the patient to avoid NOdelivery transiently exceeding the set dose by up to 0 ppm for 00 ppm cylinders.Press Nto reestablish ventilation as soon as the catheter is removed fromthe airway. his will limit the extent of over delivery above the NO set dose. Do not use dose settings above 40 ppm when using the FO option with thecutronic Fabian FO ventilator. idirectional ow through the Injector Modulemay cause over delivery which can lead to measured NO values greater than100 ppm.Integrated Pneumatic Backup he integrated pneumatic backup is intended for short term use when theelectronic delivery system fails until a replacement NO delivery device can bebrought to the bedside. he integrated pneumatic backup delivers a variable concentration of NO to thepatient depending on the ventilator ow being used. hen using the integrated pneumatic backup with breathing circuit gas ows of5 /min, the delivered NO dose will be approximately 40 ppm ( 00 ppm cylinder)or 0 ppm (400 ppm cylinder). reathing circuit gas ows less than 5 /min willdeliver an NO dose greater than 40 ppm ( 00 ppm cylinder) or 0 ppm (400 ppmcylinder). he integrated pneumatic backup ( 50 m /min.) should not be used with theunnell ife Pulse as ventilator ow rates can be very low at times, creating apotential delivered NO dose greater than 0 ppm.Part No. 20573 Rev-032015-07iii

W AR NING :Maintenance andle and dispose of sensors according to facility biohazard policies. Do notincinerate. se only Scables that are shielded (see Section / Speci cations for moredetail) . If the injector module has been used in the wet/humidi ed part of the breathingcircuit, it should be sterilized between each patient use.Manually Bagging a Patient with an Injector Module ivhe hyperin ation bag will, under some conditions, contain NO2 in excess ofone ppm. se of large tidal volume breaths may expose the patients to the NO2present in the bag for part of the breath. In general, if the inspiratory ow rateinduced by the manual ventilation does not exceed the fresh gas ow rate,the patient should not be exposed to the concentrations of NO2 present in thehyperin ation bag.dult and infant hyperin ation bags generate more NO2 when used at lowerminute ventilation. If use of the bag is interrupted (for example to adjust thetracheal tube), before resuming ventilation of the patient, the user should s ueezethe bag several times to empty residual gas from the bag.ecause of the potential for inhalation of excessive concentrations of NO2 , andthe dif culty in monitoring the peak inhaled NO2 concentrations, ventilation witha hyperin ation bag or self in ating bag is intended only for short term use.he monitoring system within the INOmax DSIR P lus will not detect generation ofNO2 within the hyperin ation bag or self in ating bag devices and the alarms forexcessive NO2 cannot warn of NO2 produced within the manual bag system.o minimize the delivered concentration of NO2 , the following steps should betaken for use with the manual resuscitator bagsoncentrations greater than 0 ppm NO should not be used because ofexcessive NO2 generation.se the smallest bag ade uate to deliver the desired tidal volume.Oxygen tubing lengths greater thaninches should not be used (between theinjector module and the bag).se the highest fresh gas ow rate (up to 15 /min) that is practical.se the lowest practical inspired oxygen concentration.fter starting fresh gas ow, s ueeze the bag several times to empty residualgas in the bag prior to using the system to ventilate a patient.Part No. 20573 Rev-032015-07

W AR NING :Manually Bagging a Patient with the INOblender he purge procedure must be followed to help ensure NO2 is purged from thesystem before the manual resuscitator bag is connected to the patient.he manual bag should be s ueezed repeatedly during use to avoid NO2 buildingup in the bag.If the bag is not s ueezed repeatedly while delivering INOM

Part No. 20003 Rev - 01Part No. 20573 Re