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Mallinckrodt INOMAX DSir Plus, Operation Manual

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Mallinckrodt INOMAX DSir Plus Operation Manual Download Page 1

Part No. 20003  Rev - 01

Part No. 20717  Rev-01

2014-07

Operation Manual

(800 ppm INOMAX® (nitric oxide) for inhalation)

Series 3 software

Summary of Contents for INOMAX DSir Plus

Page 1: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 Operation Manual 800 ppm INOMAX nitric oxide for inhalation Series 3 software...

Page 2: ...ixtures must be handled and stored in compliance with federal state and local regulations These products have unit serial numbers with coded logic which indicate the year of manufacture and a sequenti...

Page 3: ...abian HFO 3 26 A Plus Medical Babi Plus Bubble CPAP Circuit 3 27 Bagging Systems While Using the Injector Module 3 28 Bunnell Life Pulse High Frequency Ventilator Circuit 3 32 Connecting INOmax DSIR S...

Page 4: ...Limb Transport Ventilator Circuit 4 16 Connection to a Single Limb Transport Ventilator Circuit 4 17 Cylinder Leak Check 4 19 5 Alarms 5 1 Alarm History 5 3 Alarm Help 5 5 6 Calibration 6 1 Low Calib...

Page 5: ...p The valve and protection cap should operate by hand Never let oil grease or other combustible come in contact with a cylinder or valve Never remove or deface cylinder labeling or markings Never modi...

Page 6: ...isolation issues could exist Adherence to the above provides compliance to clause 20 3 Value of test Voltage in edition 2 and clause s 8 5 4 Working Voltage and Clause 8 8 3 Dielectric Strength in ed...

Page 7: ...removed from the patient and the bag purge procedure performed before continuing The INOblender should be upright when setting the oxygen flowrate for accurate setting Do not use pneumatically powere...

Page 8: ...ax DSIR is not intended to be used in other patient populations Transport If the INOmax DSIR or INOblender is to be used in a transport vehicle they should be affixed to the transport mounting post pa...

Page 9: ...n 480 mL to prevent elevated NO2 values When handling any component of the patient circuit that comes in contact with patient s fluids wear personal protective equipment PPE Patient disconnect and hig...

Page 10: ...Part No 20717 Rev 01 2014 07 viii Intentionally left blank...

Page 11: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 1 General Information General Information...

Page 12: ...Part No 20717 Rev 01 2014 07 1 General Information General Information...

Page 13: ...us integrated monitoring of inspired O2 NO2 and NO and a comprehensive alarm system The INOmax DSIR incorporates a battery that provides up to six hours of uninterrupted INOMAX delivery in the absence...

Page 14: ...DSIR Allows manual ventilation of the patient providing uninterrupted delivery of INOMAX INOMAX Nitric oxide for inhalation INOmeter Counter mounted on a cylinder that records the amount of time the I...

Page 15: ...ol Wheel 7 Injector Module Tubing Outlet 8 Injector Module Cable Inlet 9 Water Trap Bottle 10 Purge Port 11 INOMAX Gas Inlets 12 Blender Gas Outlet 13 Ethernet Port 14 Infrared Connector 15 USB Port 1...

Page 16: ...max DSIR 2 INOmax DSIR 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 Cy...

Page 17: ...Part No 20717 Rev 01 2014 07 1 5 Intentionally left blank...

Page 18: ...level Recent Alarms Screen second level Menu Screen second level Patient Information Screen second level Navigating the Menu Screen see page 1 8 Note The specific level is identified by the highlighte...

Page 19: ...Part No 20717 Rev 01 2014 07 1 7 Menu Screen second level Low Calibration Screen Settings Screen Pre Use Wizard Alarm History Screen High Calibration Screen Automated Purge Screen...

Page 20: ...Press the Settings button 6 to view circuit flow and calculated delivery graphs change display brightness change alarm volume change time zone and view software revision see Figure 1 6 1 2 4 1 Alarm S...

Page 21: ...represents the circuit flow range where the INOmax DSIR system is rated to deliver NO from 1 80 ppm see maximum NO delivery graph page 1 25 Display graphic areas in yellow represents where some inaccu...

Page 22: ...button during editing will stop the change and return the parameter to its original value similar to the escape key on a computer The touch screen buttons and control wheel are used to Set the concent...

Page 23: ...he user is facing the INOmax DSIR Cylinder icons are not visible and the NO delivery setpoint button will remain inactive until the INOmax DSIR recognizes an INOMAX cylinder Caution High frequency and...

Page 24: ...the control wheel clockwise or counterclockwise to adjust the value Dose settings Displayed dose settings are 1 5 10 20 40 60 and 80 ppm Each click on the control knob corresponds to a known change in...

Page 25: ...e the NO alarm setting high and low will automatically be set for the first setting only Any other changes will require the high and low alarm settings to be adjusted Also a two minute lockout period...

Page 26: ...icate the display brightness level desired Choices range from one darkest to 10 brightest 3 Push the control wheel to confirm the selection 4 When finished with the menu screen push the return to prev...

Page 27: ...cone projecting towards the floor see dotted lines in Figure 1 7 The specifications of the IR beam call for it to have a range of 20 cm 7 9 in Based on these specifications it sould not affect other d...

Page 28: ...in the vicinity of the INOmax DSIR cart could affect INOmeter communications If external light interference occurs we recommend taking the following actions Move the interfering light source Move the...

Page 29: ...layed on the screen Loading a second INOMAX cylinder onto the cart will result in a second cylinder icon displayed on the screen 1 2 1 2 3 4 3 4 Note Check the INOMAX gas cylinders for the correct pro...

Page 30: ...linders and with the INOvent INOmax DS and INOmax DSIR delivery systems When used with INOmax DSIR two way infrared IR communication occurs between the INOmax DSIR and the INOmeter The INOmeter commun...

Page 31: ...the iButton and press upward into socket to attach lock see Figure 1 11 Figure 1 11 iButton Close Cylinder valve to Replace Lock Figure 1 10 6 When the INOmeter is turned OFF cylinder closed the disp...

Page 32: ...e as green see Figure 1 14 Figure 1 14 Note When two INOMAX cylinders are loaded onto the cart and if both cylinder images do not appear on user screen check to see if IR or light interference is susp...

Page 33: ...ry LOT Lot Number Low Cal Low Range Calibration Main Power Connected MAX Maximum NO Backup OFF NO Backup ON NO Gas Inlet NO Gas Outlet Not Autoclavable On Peak Flow Rate Pneumatic Inlet Pneumatic Outl...

Page 34: ...INOMAX into the ventilator circuit via the injector module where it mixes with the breathing circuit gas flow to achieve the set dose This allows the INOmax DSIR to deliver a constant dose of INOMAX r...

Page 35: ...Part No 20717 Rev 01 2014 07 1 23 Figure 1 15 Schematic Diagram of INOmax DSIR Figure 1 16 INOMAX injection method provides a constant NO concentration 4 1 8 2 5 7 6 7a 7b 7c 3...

Page 36: ...ute Volume Cylinder Concentration INOMAX Dose Additional INOMAX volume added per minute Minute Volume When using volume ventilation with the INOmax DSIR the measured tidal volume delivered to the pati...

Page 37: ...ed 120 L min may be achieved Peak inspiratory flow rates are transient and extremely short in duration As a result the portion of the breath which is not matched by the INOmax DSIR is extremely small...

Page 38: ...s et al Ref 2 The NO and NO2 concentrations were measured using a chemiluminescence analyzer when 100 ppm of NO at 8 L min was delivered into a room with no scavenging being used The maximum NO and NO...

Page 39: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 2 Automated Pre Use Checkout Automated Pre Use Checkout...

Page 40: ...Part No 20717 Rev 01 2014 07 2 Automated Pre Use Checkout Automated Pre Use Checkout...

Page 41: ...ation automatically starts following the INOmax DSIR self test A Pre Use wizard will be displayed on the main screen which will provide step by step instructions to complete the pre use procedure Self...

Page 42: ...erting the connector see inset detail Connect one end of the INOMAX injector tube to the injector module and the other end into the front panel of the INOmax DSIR Check cables and hoses for signs of w...

Page 43: ...INOMAX drug cylinders onto cart and check for correct product identity labels cylinder concentration 800 ppm and expiration date Note For the CGA type INOMAX regulator connector ensure the white plas...

Page 44: ...e or cylinder oxygen hose to O2 inlet fitting on back of INOblender Note 50 psig nominal 7 Connect the Infrared cable from the INOmax DSIR cart or transport regulator cap assembly PN 10022 CGA to the...

Page 45: ...nance Cylinder Leak Check 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 an...

Page 46: ...ibration is still running after the automated purge completes wait for low calibration to complete Note Perform auto purge with device plugged in Failure to do so may result in the procedure not compl...

Page 47: ...1 in Figure 2 1 Figure 2 1 1 O2 Flowmeter Connected to wall tank 2 Injector Module Electrical Cable 3 NO N2 Injector Tube 4 Patient Gas Sample Line with Nafion 5 O2 Tubing 6 15M x 4 5 mm Adapter 7 22...

Page 48: ...AX dose is automatically set to zero Set Dose 40 ppm Acceptable O2 Value 95 3 Acceptable NO2 Value 1 5 ppm Acceptable NO Value 35 45 ppm Performance Test Note If a monitored value is outside the range...

Page 49: ...to stabilize and then verify acceptable NO value on the INOmax DSIR 5 Turn the dose and oxygen flow to zero Remove the pre use set up from the INOblender Acceptable NO Value 32 48 ppm 4 1 2 3 5 5 2 3...

Page 50: ...t any time within the next 12 hours If the regulator supply line is not depressurized the INOmax DSIR must be used within 10 minutes after completing pre use checkout procedure To depressurize the INO...

Page 51: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 3 Patient Application Patient Application...

Page 52: ...Part No 20717 Rev 01 2014 07 3 Patient Application Patient Application...

Page 53: ...se Outside of Product Labeling The INOmax DSIR must only be used in accordance with the indications usage contraindications warnings and precautions described in the INOMAX nitric oxide drug package i...

Page 54: ...ilator flow Note Connections to various ventilators are unique to each manufacturer as well as their corresponding disposable circuits Adapter diagrams can be found on page 7 13 Connect the INOmax DSI...

Page 55: ...INOmax DSIR rotate the control wheel to set the NO dose 7 Confirm the change by pressing the Control wheel or dose button on the screen 8 Set the user adjustable alarm settings on the INOmax DSIR and...

Page 56: ...ess of 80 ppm The user adjusted dose setting on the INOblender will not correlate with or have an effect on the actual delivered dose In addition the INOblender flowmeter is not back pressure compensa...

Page 57: ...OMAX cylinder supplies just the INOblender see Figure 3 4 Figure 3 3 Figure 3 4 1 Disconnect INOMAX regulator hose from back of INOmax DSIR 2 Disconnect INOblender hose from back of INOmax DSIR 3 Conn...

Page 58: ...h the NeoPuff 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 INOblende...

Page 59: ...dose is calculated by using the circuit flow measured by the injector module see Figure 3 6 The estimated NO dose table is also displayed on the main screen Note If the injector module is not function...

Page 60: ...fferent ventilator gas flows Ventilator Gas Flow L min 5 7 5 10 15 20 NO Concentration ppm 40 27 20 13 10 INOMAX cylinder conc x 0 25 L min ventilator flow delivered dose When the backup switch is tur...

Page 61: ...ent without first contacting the manufacturer Never use an adaptor to connect a cylinder to the system Never use equipment not designed to use INOMAX mixtures Never attempt to repair a leak on a cylin...

Page 62: ...2 Open and then close the valve on the new INOMAX cylinder Check for adequate cylinder pressure Monitor pressure gauge for 30 seconds for any signs of leakage If there is a decrease check for leaks ar...

Page 63: ...lator pressure gauge reads zero this purges any NO2 that has accumulated in the hose and regulator 4 Connect the hose to the back NO N2 inlet of the INOmax DSIR When having difficulty connecting the I...

Page 64: ...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 DSI...

Page 65: ...nitric oxide for inhalation Illustrative Only Please note The calculations on this chart have been determined based on an 800 ppm cylinder of INOMAX nitric oxide for Inhalation This chart is represen...

Page 66: ...otal continuous flow cylinder conversion factor 14 2 liters per bar and 0 98 liters per psig INOMAX flow Desired dose total ventilator flow Cylinder concentration desired dose Cylinder volume Cylinder...

Page 67: ...ontinuous flow cylinder conversion factor 2 6 liters per bar and 0 18 liters per psig INOMAX flow Desired dose total ventilator flow Cylinder concentration desired dose Cylinder volume Cylinder conver...

Page 68: ...mpty and clean the water trap bottle before each patient use and empty whenever the trap is more than half full Empty the water trap bottle routinely Allowing it to fill and overflow may cause system...

Page 69: ...battery will run the INOmax DSIR for up to six hours in optimal conditions Battery life can be extended by keeping the display brightness and the audio alarm volume to the minimum Display brightness a...

Page 70: ...hobic disk filter with luer connections must be placed between the sample line and sample tee see Figure 3 10 Note The disk filter is to be used in conjunction with the INOmax DSIR water separator car...

Page 71: ...d read the NO and NO2 readings 4 After environmental monitoring remove the Luer fitting cap on the sample tee and reconnect the sample line 1 Disconnect the sample line connector from the sample tee 2...

Page 72: ...r screen see Figure 3 13 allows a unique alphanumeric patient identifier to be entered that contains six to eight characters note spaces will be accepted 1 Press the Enter Patient Identifier button to...

Page 73: ...he CONFIRM button will illuminate when six characters have been entered 1 2 1 2 Figure 3 13 Press the Select Patient Type button and rotate the control wheel to select either neonate pediatric or adul...

Page 74: ...3 15 Figure 3 16 Press the CONFIRM button to enter the patient details selected see Figure 3 16 Figure 3 17 Prior to confirming the gestational age and birth weight digits can be changed either by pr...

Page 75: ...he 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 pat...

Page 76: ...ith the indications usage contraindications warnings and precautions described in the INOMAX nitric oxide drug package inserts and labeling Caution The INOmax DSIR is designed to function in the param...

Page 77: ...on 3 Injector Module Electrical Cable 4 INOmax DSIR 5 NO N2 Injector Tube 6 Connecting Tube 15 inches 7 Injector Module 8 22F X 15M Adapter 9 Humidifier 10 Inspiratory Breathing Circuit Hose 11 Gas Sa...

Page 78: ...bian HFO Ventilator 2 Patient Gas Sample Line with Nafion 3 Injector Module Electrical Cable 4 INOmax DSIR 5 NO N2 Injector Tube 6 Injector Module 7 T Connector Assembly 7209 e 8 Connecting Tube 15 in...

Page 79: ...perature Probe 6 90 Degree Sample Port Adapter 7 Nasal Prongs 8 Babi Plus Bubble PAP Valve 9 Tee Adapter 10 Breathing Circuit 11 Humidifier 12 NO N2 Injector Tube 13 Injector Module Electrical Cable 1...

Page 80: ...l for inhalation of excessive concentrations of NO2 and the difficulty in monitoring the peak inhaled NO2 concentrations ventilation with a hyperinflation bag or self inflating bag is intended only fo...

Page 81: ...tion 0 5L Neonatal 5403 Nellcor Puritan Bennett Self inflating 1 76 L Adult 655005 Nellcor Puritan Bennett Self inflating 0 52 L Infant 616416 Caution New O2 tubing must be used each time for optimal...

Page 82: ...suscitator 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 Use the highes...

Page 83: ...Part No 20717 Rev 01 2014 07 3 31 Intentionally left blank...

Page 84: ...up 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 Bunnell Life Pulse in standby prior to suctioning th...

Page 85: ...Vent 4 15M X 4 5 mm I D Adapter 5 22M 15F X 22M 15F Adapter 1 2 4 5 6 Injector Module 7 15M X 4 5 mm I D Adapter 8 Three cm Piece of Green Gas Out Tube 9 One Way Valve 10 Green Gas Out Tube to Humidi...

Page 86: ...ess than the same Set NO value at 100 O2 For example at a Set NO value of 20 ppm measured NO will be approximately 18 ppm Similarly the effect of two percent v v Isoflurane will result in a high measu...

Page 87: ...ent Gas Sample Line Input Connection 3 INOmax DSIR 4 Bellows Assembly 5 Ventilator 6 Ventilator Drive Gas 7 Absorber Expiratory Port 8 Absorber Inspiratory Port 9 Absorber 10 Injector Module a Injecto...

Page 88: ...el Connection 8 Injector Module Electrical Cable Front Panel Connection 9 Injector Module 10 One Way Valve 11 Humidifier Inlet 12 Humidifier 13 Humidifier Outlet 14 Patient Gas Sample Line with Nafion...

Page 89: ...Infant Interface 9 Bubble CPAP Generator 10 F P Inline Infant Nebulizer Kit RT010 Adapter 11 Breathing Circuit 12 Humidifier 13 NO N2 Injector Tube 14 Injector Module Electrical Cable 15 INOmax DSIR...

Page 90: ...bing 5 22F X 15M Adapter 6 Injector Module 7 Pressure Relief Manifold 8 22M 15F X 22M 15F Adapter 9 Injector Module Electrical Cable 10 NO N2 Injector Tube 11 Humidifier 12 Breathing Circuit 13 Temper...

Page 91: ...jector Module Electrical Cable 7 NO N2 Injector Tube 8 22F X 15M Adapter 9 Humidifier 10 Breathing Circuit 11 Temperature Probe 12 Gas Sample Tee 12 14 11 15 2 1 7 5 4 6 3 8 9 10 16 17 13 Figure 3 31...

Page 92: ...1 Arabella 2 Patient Gas Sample Line with Nafion 3 INOmax DSIR 4 NO N2 Injector Tube 5 Injector Module Electrical Cable 6 Injector Module 7 22F X 15M Adapter 8 Humidifier 9 Heated Delivery Circuit 10...

Page 93: ...rt 6 Patient Gas Sample Line Input Connection 7 INOmax DSIR 8 NO N2 Injector Tube Front Panel Connection 9 Injector Module Electrical Cable Front Panel Connection 1 3 7 11 9 12 13 4 5 6 8 15 16 17 2 1...

Page 94: ...ction 6 INOmax DSIR 1 2 4 6 7 NO N2 Injector Tube 8 8 mm Tubing X 15M Adapter 9 One Way Valve 10 Paw Limit Valve Control 11 Filter 12 Humidifier Inlet 9 10 11 12 15 11 13 17 18 14 5 7 16 3 8 13 Humidi...

Page 95: ...tilator 2 Ventilator Outlet 3 Injector Module 4 INOmax DSIR 5 NO N2 Injector Tube Connection 6 Injector Module Electrical Cable Connection 7 One Way Valve 1 2 3 4 8 22 mm ID X 22 mm ID Cuff Adapter 9...

Page 96: ...ectrical Cable 7 Injector Module 8 22F X 15M Adapter 9 Humidifier 10 Inspiratory Breathing Circuit Hose 11 Expiratory Breathing Circuit Hose 12 Gas Sample Tee Figure 3 36 Example SLE Life Support SLE5...

Page 97: ...ector Module 7 Breathing Circuit Hose 8 Gas Sample Tee 9 22M 15F X 22M 15F Adapter 10 One Way Valve 11 Sealed Face Mask 12 One Way Valve 13 Patient Gas Sample Line with Nafion 14 NO N2 Injector Tube 1...

Page 98: ...prior to delivery through the injector module will help ensure the most accurate flow measurement Conditioning can be achieved by adding 300 mm of 22 mm hose between the oxygen tubing and the Injecto...

Page 99: ...Patient Circuit 10 Temperature Probe Connector 11 Second Temperature Probe Connector 12 Comfort Flo Cannula 10 17 14 3 1 2 11 18 9 12 Figure 3 39 Example Teleflex Comfort Flo Patient Circuit Diagram...

Page 100: ...Patient Gas Sample Line with Nafion 15 NO N2 Injector Tube 16 Injector Module Electrical Cable 10 1 14 12 9 8 15 16 11 7 6 5 4 3 2 13 The INOmax DSIR adds NO N2 gas flow to the breathing circuit flow...

Page 101: ...on Flow 4 8 The INOmax DSIR adds NO N2 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 nomi...

Page 102: ...Flow CPAP System Circuit Diagram 1 INOmax DSIR 2 Heated Delivery Circuit 3 Infant Flow System 4 Infant Flow Generator 5 Sample Tee 6 Temperature Probe 7 Patient Gas Sample Line with Nafion 8 Humidifi...

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Page 104: ...established by specific flow settings See table below The maximum flow error is approximately 11 at two L min which is within the accuracy of the flow meter specification 15 It is recommended that af...

Page 105: ...bdominal Respiratory Sensor 3 Transducer Interface 4 Infant Flow SiPAP 5 Infant Flow Generator 6 Sample Tee 7 Temperature Probe 8 Heated Delivery Circuit 9 Humidifier 10 22F X 15M Adapter 11 Injector...

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Page 107: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 4 Transport Transport...

Page 108: ...Part No 20717 Rev 01 2014 07 4 Transport Transport...

Page 109: ...ough drug to last through the transport including unexpected delays Bring additional cylinders as appropriate 2 Connect the INOblender oxygen hose to a 50 psig portable oxygen source 3 Manually ventil...

Page 110: ...cylinder 2 Place the cap assembly over the INOmeter 3 Open then close the INOMAX transport cylinder valve Note Be sure to align the key way inside the Cap Assembly with the ibutton on the INOmeter 1 3...

Page 111: ...egulator 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 tra...

Page 112: ...13 Connect the INOblender inlet hose to the INOmax DSIR INOblender outlet and slide the quick connect cover into place Upon return 14 Return the INOblender to the cart and secure the clamp assembly 1...

Page 113: ...AX cylinder valve and insert the regulator hose into available INOMAX gas inlet 17c Close transport cylinder valve and remove the regulator hose from the INOMAX gas inlet and depressurize the regulato...

Page 114: ...nnect INOblender hose from back of INOmax DSIR 3 Connect INOMAX regulator hose to INOblender inlet hose Typically the INOblender receives INOMAX from the INOmax DSIR INOMAX cylinder supplies both devi...

Page 115: ...0 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 Turn the O2 flowmeter to the desired flow rate 5 to 14 L min 8 Sque...

Page 116: ...INOblender will not correlate with or have an effect on the actual delivered dose In addition the INOblender flowmeter is not back pressure compensated and will display a lower flow rate than actual...

Page 117: ...the INOblender set the INOMAX dose to 40 ppm and O2 flow to 10 L min 4 Verify NO value on the INOmax DSIR 5 Turn the dose and oxygen flow to zero 6 Remove the Pre Use set up from the INOblender Accept...

Page 118: ...high pressure leak test successful proceed to Delivery Confirmation and Purge 5 If observed pressure decrease continues see Section 7 Maintenance Cylinder Leak Check 6 If leak cannot be traced replac...

Page 119: ...values are out of range during the pre use checkout 2 Bring appropriate backup equipment in case of a malfunction during the transport see caution above Items recommended for interhospital transport...

Page 120: ...tinuous flow cylinder conversion factor 2 6 liters per bar and 0 18 liters per psig INOMAX flow Desired dose X total ventilator flow Cylinder concentration desired dose Cylinder volume Cylinder conver...

Page 121: ...ure 4 3 Note Before leaving the bedside intrahospital transport or hospital interhospital transport check the INOMAX cylinder for the correct product identity labels cylinder concentration and expirat...

Page 122: ...igure 4 7 and 4 8 Note Notice that the connector clicks to indicate that it is latched in place Do not attempt to connect the transport regulator cap assembly electrical plug to the INOblender outlet...

Page 123: ...r the boot up phase of the INOmax DSIR is complete WARNING Loss of communication between the INOmax DSIR and the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery N...

Page 124: ...2 Expiratory Breathing Circuit Hose 3 Patient Gas Sample Line with Nafion 4 Ventilator Expiratory Valve 5 Ventilator 6 INOmax DSIR 7 Ventilator Inspiratory Port 1 2 9 8 10 11 3 4 5 7 12 13 6 8 22M 15F...

Page 125: ...tor Diagram 1 PEEP Valve 2 Patient Wye 3 Circuit Hose 4 Patient Gas Sample Line with Nafion 5 Ventilator 6 INOmax DSIR 7 Ventilator Inspiratory Port 1 2 9 8 10 11 3 4 5 7 12 13 6 8 22M 15F X 22M 15F A...

Page 126: ...see Figure 4 13 Note The universal mounting post has a machined recess with an integrated cap to prevent twisting or accidental release of the device if the mounting clamp assembly becomes loose Cauti...

Page 127: ...e detected 1 A leak detected at points 1 and 2 may be corrected by tightening the INOMAX regulator hand wheel a If cylinder valve is open close cylinder valve relieve regulator pressure by purging tig...

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Page 129: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 5 Alarms Alarms...

Page 130: ...Part No 20717 Rev 01 2014 07 5 Alarms Alarms...

Page 131: ...quency Description Comment High Priority 400 Hz 10 pulse group Repeats after 10 sec if not silenced Low Priority 400 Hz 1 pulse Repeats after 40 sec if not silenced The following table provides the au...

Page 132: ...ytime the Monitor Alarm Delay Active indicator is displayed This delay only effects the monitor alarms all other alarms remain active The Monitor Alarm Delay Active indicator will be displayed for two...

Page 133: ...t have occurred Note Alarm history dates and times are displayed per user set off set time see Time Adjust setting page 1 14 Alarm conditions lasting less than one second may not display in the alarm...

Page 134: ...priority alarm and a red dot signifies a high priority alarm The duration of an alarm is truncated to the second or minute label displayed in the format xx label where xx and label are as defined in...

Page 135: ...or module Injector module cable Remove and discard Patient gas sample line NO N2 injector tube 2 Pack the INOmax DSIR and the accessories as requested by Customer Care Use the original or service loan...

Page 136: ...Support Alarm Help Continuous Audible Tone Alarm Possible Cause Recommended Action Continuous Audible Tone A component within the INOmax DSIR has failed 1 If the INOblender is available manually venti...

Page 137: ...ample line may be disconnected 1 Check circuit for correct setup 2 Confirm water trap bottle water separator cartridge and patient gas sample line are in place e The NO calibration may have drifted 1...

Page 138: ...2 alarm setting may be inappropriately set Confirm high O2 alarm limit is set appropriately b The patient breathing circuit setup may be incorrect Check circuit for correct setup c The O2 calibration...

Page 139: ...cylinder on cart d Transport Cap not connected to the INOmeter If utilizing a transport regulator cap assembly 1 Connect transport regulator cap assembly cable to infrared connector on back of INOmax...

Page 140: ...f the back up INOMAX delivery options 2 Turn INOmax DSIR to standby then restart 3 Once device is ready to restart therapy 4 Turn integrated back up off if used and then set the INOMAX dose 5 Confirm...

Page 141: ...s from point when cylinder valve is opened a INOMAX cylinder is the wrong concentration 1 Close mismatched cylinder valve 2 Remove wrong concentration INOMAX cylinder from INOmax DSIR cart 3 Connect a...

Page 142: ...ons can be performed while delivering INOMAX to the patient a Cylinder valve is closed Confirm INOMAX cylinder valve is fully open b The NO cylinder supply may be low If INOMAX regulator gauge reads l...

Page 143: ...Sensor Delivery of INOMAX continues during this alarm a NO calibration may have drifted 1 Perform low calibration 2 Perform high NO calibration b There is a leak around the sensors Confirm the O ring...

Page 144: ...o communicate correctly or is reporting a fault 1 Confirm patient gas sample line is not occluded 2 Confirm water trap bottle and water separator cartridge are in place 3 Change patient gas sample lin...

Page 145: ...y but the message remains in the alarm message box Remove water trap bottle and clean optical sensor level indicator with an alcohol swab Contact Technical Support 25 Low Calibration Failed All of the...

Page 146: ...user action required c Following completion of an auto purge Monitor alarms for O2 NO2 and NO will be inactive anytime the Monitor Alarm Delay Active indicator is displayed This delay only affects the...

Page 147: ...5 Shield the INOmeter from the suspect light source b IR cable is not connected to the back of the INOmax DSIR Verify the IR cable is connected to the back of the INOmax DSIR c Integrated pneumatic b...

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Page 149: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 6 Calibration Calibration...

Page 150: ...Part No 20717 Rev 01 2014 07 6 Calibration Calibration...

Page 151: ...ess the menu button on the main screen to enter the menu screen second menu level Calibration Area The lower part of the screen displays the low calibration Low Cal and high calibration High Cal butto...

Page 152: ...f the low calibration is canceled after boot up the device will reattempt again every 15 minutes until successful If an automatic low calibration fails it will reattempt the calibration a second time...

Page 153: ...tion If a sensor has failed the display will indicate the failed sensor symbol in the monitoring area of that sensor Press the Alarm Help button for on screen alarm help or see Section 5 Alarms 3 When...

Page 154: ...g 3 15M X 4 5 mm I D Adapter 4 Gas Sample Tee 5 Patient Gas Sample Line with Nafion 1 2 5 3 4 3b 3a 3c Caution When performing a high calibration make sure to select the correct calibration gas and co...

Page 155: ...l 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 Press the CANCEL button to exit th...

Page 156: ...nitoring area of that sensor Repeat calibration press the Alarm Help button for on screen alarm help or see Section 5 Alarms If the calibration was unsuccessful the O2 progress bar will turn red Attem...

Page 157: ...and contaminants 2 Check seal on regulator Verify it is correctly in place and undamaged 3 Attach regulator to cylinder Turn regulator nut counter clockwise to tighten 4 NOTE Tubing adapter will be r...

Page 158: ...u level press the 45 ppm NO button to initiate the NO high calibration 9b 9a 9c Note If the date is flashing on the high calibration screen the calibration is past due 6 Open the INOcal cylinder valve...

Page 159: ...y removed from patient breathing circuit A Monitor Alarm Delay Active indicator will occur anytime the user exits the calibration screen even if a calibration was not initiated All other alarms are st...

Page 160: ...ar will turn red Attempt another calibration 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...

Page 161: ...llowing circumstances The tubing is discolored or stiff There is a crack or break in the tubing Caution When performing a high calibration make sure to select the correct calibration gas and confirm t...

Page 162: ...EXT button 9b To start the high calibration without using the wizard press the START CAL button 9c To exit the NO2 high calibration wizard press the CANCEL button 8 From the high calibration screen th...

Page 163: ...calibration tubing and close the INOcal cylinder valve Note Reconnect patient gas sample line if previously removed from patient breathing circuit A Monitor Alarm Delay Active indicator will occur an...

Page 164: ...on screen alarm help or see Section 5 Alarms When using the high calibration wizard if the BACK button is pressed during the NO2 high calibration process the progress bar will turn yellow signifying a...

Page 165: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 7 Maintenance Maintenance...

Page 166: ...Part No 20717 Rev 01 2014 07 7 Maintenance Maintenance...

Page 167: ...emergency power backed electrical outlet 5 Make sure the connectors hoses and cables are in good condition Monthly 1 Perform a low and a high calibration of NO NO2 and O2 2 Check INOMAX regulators for...

Page 168: ...s 95 157 Caution Do not autoclave or gas sterilize the INOmax DSIR Do not clean with the power connected and the INOmax DSIR turned ON Be sure that the INOmax DSIR is completely dry before using Do no...

Page 169: ...ticide Fungicide and Rodenticide Act FIFRA Use of these products in cleaning disinfection processes have not been validated with the INOmax DSIR Do not use these products to decontaminate the INOmax D...

Page 170: ...ing Do not saturate the INOmeter with excessive solution Liquid may flow into the device and damage internal components Do not use organic petroleum based solvents glass cleaners acetone or other hars...

Page 171: ...evaporate completely before using the injector module Note Do not insert anything into the injector module throat in an effort to remove contamination or to dry If lint fibers remain wrapped around th...

Page 172: ...e see Figure 7 3 To install O2 sensor remove the shorting button and insert the contact end open end with three gold rings into recess until it seats no specific orientation is necessary Note The shor...

Page 173: ...Figure 7 5 NO2 Shorting Wire Replacing the O2 NO and NO2 Sensors cont d Perform a low and high calibration for the sensor before returning the system to use Note Newly Installed Sensor Time to Conditi...

Page 174: ...the sample line occlusion alarm message appears 1 Disconnect the regulator from the INOMAX drug cylinder Replacing the CGA 626 tip on the INOMAX regulator 2 Remove the old CGA 626 tip by pulling on th...

Page 175: ...hould the sleeve be in the forward position the inlet valve will be open and the INOMAX regulator hose will not securely connect to the inlet see Figure 7 9 3 Insert the connector from the regulator h...

Page 176: ...d 1 A leak detected at points 1 and 2 may be corrected by tightening the INOMAX regulator hand wheel a If cylinder valve is open close cylinder valve and tighten INOMAX regulator hand wheel b Open cyl...

Page 177: ...ple system tubing and filters Replace NO2 sensor Preventative Maintenance Equipotential grounding is the bonding of all conductive surfaces in the room together and to earth This can be implemented in...

Page 178: ...150 INOcal Calibration Gas NO2 10 ppm BOM COM 0162 INOcal Regulator Kit 10090 INOmaxDSIR Cart 10018 INOMAX Regulator CGA 626 10006 INOblender Extension Hose 10014 INOMAX Transport Regulator Cap Assemb...

Page 179: ...gree Sample Port Bunnell Life Pulse Disposable Adapters Convenience Pack Disk Filter 0 5 micron Neonatal Tubing 10 mm 2 pieces NO N2 Injector Tube One way Valve 22F X 22M Patient Gas Sample Line Nafio...

Page 180: ...Part No 20717 Rev 01 2014 07 7 14 Intentionally left blank...

Page 181: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 8 Product Specifications Product Specifications...

Page 182: ...Part No 20717 Rev 01 2014 07 8 Product Specifications Product Specifications...

Page 183: ...on is limited to term and near term neonates with hypoxic respiratory failure The INOmax DSIR is not intended to be used in other patient populations Outside of the United States use of the INOmax DSI...

Page 184: ...ger Narcomed 2B eVent Medical Inspiration LS Fisher Paykel Healthcare Bubble CPAP System Fisher Paykel Healthcare Infant Circuit Nasal Cannula Kit Fisher Paykel Healthcare Optiflow Breathing Circuit...

Page 185: ...sal Cannula NA Newport E360 Newport HT50 Newport Wave Pulmonetic Systems LTV 1000 Pulmonetic Systems LTV 1200 Puritan Bennett 7200 Puritan Bennett 840 Respironics Esprit Sechrist IV 100B Sensormedics...

Page 186: ...Adult Transport High Frequency Anesthesia Nasal Continuous Positive Airway Pressure CPAP High Flow Nasal Cannula Acutronics Medical Systems AG Fabian nCPAP Evolution Acutronics Medical Systems AG Fab...

Page 187: ...let 22 mm male and 15 mm female Autoclavability Autoclavable at 134 C for 3 minutes at 27 psig Maximum Pressure Drop 1 5 cmH2O at 60 L min Gas Monitoring Gas Range Resolution Accuracy Nitric Oxide 0 1...

Page 188: ...t is connected Ethernet Port For service only Not for use when patient is connected RS232 Enables serial communications foruse with hospitalelectronic health record EHR system see specifications on pa...

Page 189: ...ed to RS 232 ports that have Four kV input to output isolation Four kV input to mains isolation and an internal reference voltage U as defined in section 20 3 of IEC60601 1 edition two of less than or...

Page 190: ...sion and user generated patient identifier Monitored values Monitored O2 NO2 and NO Settings Dose setpoint Alarm setpoints High O2 low O2 high NO2 high NO and low NO Alarm messages Device status INOMA...

Page 191: ...dance RF emissions CISPR 11 Group 1 The INOmax DSIR system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby...

Page 192: ...line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions a...

Page 193: ...the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The...

Page 194: ...3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of...

Page 195: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 Appendix 9 Appendix...

Page 196: ...Part No 20717 Rev 01 2014 07 Appendix 9 Appendix...

Page 197: ...t The power cord must always be connected to an electrical outlet to maintain a full battery charge 9 Appendix Manual Pre Use Checkout An INOmax DSIR splash screen will appear once the device is turne...

Page 198: ...or module before inserting the connector see inset detail Connect one end of the INOMAX injector tube to the injector module and the other end into the front panel of the INOmax DSIR Check cables and...

Page 199: ...two INOMAX drug cylinders onto cart and check for correct product identity labels cylinder concentration 800 ppm and expiration date 5 Connect an INOMAX regulator to one of the INOMAX cylinders and h...

Page 200: ...If using the INOblender with the INOmax DSIR connect the INOblender inlet hose to the INOmax DSIR INOblender outlet and slide the quick connect cover into place Connect oxygen supply wall source or cy...

Page 201: ...se is observed high pressure leak test is successful If there is an observed pressure decrease see Section 7 Maintenance Cylinder Leak Check High Pressure Leak Test WARNING A new INOMAX cylinder and r...

Page 202: ...X cylinder valve 5 Turn the INOMAX dose to zero The Set Dose is Zero Close Cylinder Valve indicator will appear This indicator will display anytime the set dose is returned to zero however during this...

Page 203: ...Allow 2 3 minutes for monitored values to stabilize If a monitored value is outside the range indicated do a high range calibration for that sensor 1 Verify that the O2 flowmeter is set to 10 L min 2...

Page 204: ...w to 10 L min 4 Verify values on the INOmax DSIR 5 Turn the dose and flow to zero and remove the Pre Use set up from the INOblender Acceptable NO Value 32 48 ppm 4 1 2 3 5 5 2 3 40 ppm INOblender Test...

Page 205: ...Part No 20003 Rev 01 Part No 20717 Rev 01 2014 07 Intentionally left blank...

Page 206: ...Part No 20717 Rev 01 2014 07 Mallinckrodt Manufacturing LLC 6603 Femrite Drive Madison WI 53718 6801 USA 877 566 9466...

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