CareFusion Infant Flow LP SiPAP Page 96 Service Manual Download

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Infant Flow

LP SiPAP Model M675

675-120 Rev. G

Term

Meaning

apnea

/ T

LBR

Apnea Interval (non-US labeling) or Low Breath Rate (LBR)
monitor alarm time (US-labeling); both in seconds
This mnemonic may also be associated with an alarm icon



-High

Machine breath inspiration time (seconds)

Treatment

Application of NCPAP, BiPhasic, BiPhasic Tr, with or without
breath monitoring, to the patient

US labeling

Labeling using English text in place of symbols and/or icons

Summary of Contents for Infant Flow LP SiPAP

Page 1: ...Infant Flow LP SiPAP and SiPAP Model M675 Service manual ...

Page 2: ... only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement 2008 2011 CareFusion Corporation or one of its subsidiaries All rights reserved Infant Flow is a registered trademark of CareFusion Corporation or one of its subsidiaries All other trademarks are property of their respective owners USA CareFusion 22745 Savi Ranch Parkway Yorba Linda C...

Page 3: ...ages 56 and 57 Replaced the warning on page 61 Changed the Fitting procedure on pages 64 68 and 75 Changed step 6 on page 65 Added Addendum A Oxygen Leak Test Changed Transducer Assy To Transducer Interface on page 88 May 2005 D Revised per ECO 60329 Update address contact info Update battery remove install procedure Added note for fuel cell disposal Update check valve assembly remove install proc...

Page 4: ...nder Check Valves and Filter Annually from table 7 Added and two screws on the case bottom Added and document L2879 Replaced Ti symbol with T High symbol Changed PL5 to PL2 Replaced Figure 3 Replaced Figure 4 and 5 Changed value doesn t to value on the external oxygen analyzer doesn t Changed 467352 to 68289 changed 777245 to 52700A removed items 677 005A 675 311 S117635 467461 467460 Removed item...

Page 5: ... based upon a claim for breach of warranty other than the purchase price of any defective product covered hereunder The Company warranties as herein and above set forth shall not be enlarged diminished or affected by and no obligation or liability shall arise or grow out of the rendering of technical advice or service by the Company or its agents in connection with the Buyer s order of the product...

Page 6: ...tice x Chapter 1 Product Description 1 Chapter 2 Product Specifications 3 Modes 3 Controls 3 Monitors 3 Alarms 4 Pneumatic Supply 4 Electrical Supply 4 Atmospheric Environmental 5 Physical 5 Chapter 3 Warnings and Cautions 7 Terms 7 Warnings 7 Cautions 9 Chapter 4 System Construction 11 Touch Screen 15 Alarm Conditions 17 Diagnostic Screen 17 Chapter 5 Theory of Operation 19 Gas Flow 19 Electronic...

Page 7: ... Frequencies 55 PM Procedure 55 Tools Required 55 Cleaning 56 General 56 Removal and Fitting of Case 59 Removal and Fitting of Battery 60 Removal and Fitting of Oxygen Filter 61 Removal and Fitting of Fuel Cell Filter Restrictor 62 Removal and Fitting of the Oxygen Sensor 63 Removal and Fitting of Blender and Components 64 Removal and Fitting of Water Trap Filter 68 Removal of the Pilot Drive Chec...

Page 8: ...s manual This device is also designed and manufactured to comply with the following standards Safety UL 60601 1 2003 Medical Electrical Equipment Part 1 General Requirements for Safety CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety including C22 2 No 601 1S1 94 IEC601 1 Amendment 1 1991 Supplement No 1 94 to CAN CSA 22 2 No 601 1 M90 With regards to ...

Page 9: ...roughly understand the contents of this manual before using or maintaining the equipment This manual is intended for use by a competent fully qualified Service Engineer It includes a description of the unit and how it works It also contains operating and diagnostic procedures and maintenance instructions For usage of associated equipment refer to the Manufacturer s literature Regulatory Notice Fed...

Page 10: ...3 42 EEC Annex II excluding section 4 Safety EN 60601 1 EN 794 1 EMC EN 60601 1 2 2001 Conformity Assessment MDD Annex II Quality System ISO 13485 EU Notified Body BSI Reg No 0086 Device Classification IIb EU Notified Body BSI Reg No 0086 Trade names Infant Flow LP SiPAP Manufactured by CareFusion 22745 Savi Ranch Parkway Yorba Linda CA 92887 USA If you have a question regarding the Declaration of...

Page 11: ...ries include circuits and generators prong and mask patient interfaces and bonnets Infant Flow LP SiPAP and SiPAP Features The expanded capabilities of the Infant Flow LP SiPAP and SiPAP Plus and Comprehensive configurations allow for applications to a broader range of patients who may otherwise not be candidates for non invasive respiratory support NCPAP Allows for continuous positive airway pres...

Page 12: ...s and Accessories Functions Accessories Plus Comprehensive NCPAP NCPAP with breath rate monitoring and alarm BiPhasic BiPhasic with breath rate monitoring and alarm BiPhasic tr Internal Battery Manual Breath Apnea Back up rate Screen lock Prioritization of alarms Comprehensive configuration not available for sale in the United States CAUTION The Infant Flow LP SiPAP and SiPAP systems have been des...

Page 13: ...h 0 1 3 0 seconds Rate R 1 120 Comprehensive only The comprehensive configuration is not available for sale in the United States Rate R 1 54 Plus only Apnea Interval Tapnea 10 30 seconds 5 second intervals Comp only Apnea Interval TLBR 10 30 seconds 5 second intervals Plus only NCPAP Pres Low flowmeter 0 15LPM accuracy 15 of selected output NCPAP Pres High flowmeter 0 5LPM accuracy 15 of selected ...

Page 14: ...rm Low or Flat battery charge level Alarm volume electronic alarms 70 dBa at 1 meter Pneumatic Supply Patient Gas Outlet 15 mm standard taper fitting Patient Pressure Input 4 5 mm Luer taper fitting Gas Supply Nominal 4 bar or 60 psi clean dry medical air and oxygen Range 2 8 to 6 bar 40 to 90 psi maximum differential pressure 2 bar 30 psi Manometer Range 0 to 20 cmH2O accuracy 2 of span Gas Conne...

Page 15: ...ronmental Temperature Range Operating 5 40 C Storage 0 50 C Relative Humidity Operating 0 90 non condensing Storage 0 90 non condensing Physical Dimensions driver only W x H x D 26 x38 x 23 5 cm 10 25 x15 x 9 25 in Weight driver only 8 8 kg 19 5 lb ...

Page 16: ...6 Infant Flow LP SiPAP Model M675 675 120 Rev G Infant Flow LP SiPAP and SiPAP Model M675 ...

Page 17: ...r other equipment NOTES identify supplemental information to help you better understand how the ventilator works Warnings Whenever a patient is attached to respiratory care equipment constant attendance is required by qualified personnel The use of an alarm or monitoring system does not give absolute assurance of warning for every malfunction that may occur in the system In addition some problems ...

Page 18: ...es are restrained to avoid hazard of toppling This equipment is not suitable for use in the presence of a flammable anesthetic mixture The NCPAP Pres High flowmeter must be adjusted to zero when not required for the patient Under extreme conditions minimum supply pressure and maximum gas demand including auxiliary output output flow rates and delivered pressure may be reduced Only use the supplied...

Page 19: ...e verify that this equipment has been authorized for use by a qualified person The Infant Flow LP SiPAP and SiPAP systems have been designed and tested as complete systems using Infant Flow SiPAP accessories Only accessories approved for use should be used If in doubt please contact your local CareFusion representative Where the integrity of the external protective earth conductor is in doubt the ...

Page 20: ...10 Infant Flow LP SiPAP Model M675 675 120 Rev G Infant Flow LP SiPAP and SiPAP Model M675 ...

Page 21: ...e or function If the AC power supply fails or is disconnected the IFSD automatically switches to battery power and gives an audio and visual alarm The IFSD is enclosed in a case with Operator controls and input connectors on the front and rear panel The front panel is shown in Figure 1 The back panel is shown in Figure 2 The case incorporates non slip feet for table top use or must be fitted to a ...

Page 22: ...e provides an auxiliary gas outlet optional and provides switched Biphasic flow The main components are an air oxygen blender a flow manifold a vent valve an exhaust manifold with alarm whistle NCPAP Pres low and NCPAP Pres high flowmeters and a valve sensor PCB The inlet gas connections are on an interchangeable inlet block to allow for different gas fittings The exhaust manifold discharges gas t...

Page 23: ... read the gas module sensors The main components are a power supply unit a rechargeable battery a main processor PCB LED PCB Valve Sensor PCB and a LCD screen touch screen The LCD screen includes a back light which is always on when the IFSD is powered The touch screen displays information and receives inputs from the Operator via the touch screen keyboard Figure 2 IFSD Back Panel Leak Test Port ...

Page 24: ...14 Infant Flow LP SiPAP Model M675 675 120 Rev G Figure 3 IFSD Internal Components ...

Page 25: ...s to instruct the microprocessor how to control the unit and to interact with the Operator Touch Screen The touch screen provides the Operator with a series of screens with icons to enable settings calibration and fault diagnosis The Start Up Screen is shown in Figure 4 The display includes a status bar which incorporates a battery status mode indicator alarm button and patient trigger indicator T...

Page 26: ...ring an alarm condition Mode Indicator The Mode Indicator shows four question marks when in Start up or Adjust and changes to show the applicable mode in use e g NCPAP Figure 4 Touch Screen Display Start Up Patient Trigger Indicator Plus and Comprehensive Models The Patient Trigger indicator changes to when the transducer interface is connected and ready to be connected to the patient and indicate...

Page 27: ... two different intermittent tones medium or high level medium level sounds beep beep beep every 15 seconds and high level sounds beep beep beep beep beep every 10 seconds a visual Warning Bar which flashes red continuously flashes intermittently or comes on continuously an Alarm Button on the touch screen status bar which flashes continuously Other indications are given to indicate the status of t...

Page 28: ...d 5 which indicates Triggered BiPhasic is enabled 1 or disabled 2 APB 1 or 0 controlled by DIP 2 which indicates that Apnea BiPhasic is enabled 1 or disabled 0 The remaining symbols provide the default and ranges for inspiratory time and breath rate controlled by DIP 1 LCD The LCD box shows the ambient light sensor voltage AMB the back light level BLL and if the backlight is operative BLF 1 for fa...

Page 29: ...xygen analyzer utilizes a galvanic fuel cell to measure and display the measured delivered oxygen concentration A vent valve on the exhaust manifold incorporates a solenoid operated pilot valve and a large orifice spool valve The vent valve is normally held in the open position by a spring to vent high flow rates with low pressure drops so that the patient pressure is minimal The electrically actu...

Page 30: ...20 Infant Flow LP SiPAP Model M675 675 120 Rev G Figure 6 IFSD Gas Flow Schematic ...

Page 31: ... High Flowmeter when not delivering to the patient flows through a restrictor to exhaust allowing the flowmeter to be adjusted without delivering gas to the patient The flow rate is shown on the gauge on the flowmeter When the flowmeter control knob is turned fully clockwise the flow of gas is turned off The flow is directed to the patient via a high speed selector valve which operates when reques...

Page 32: ...ine whether the valve is connected or short circuited Current to the valve sensor PCB is limited via the fuses below a 10 VA limit to ensure safety in a possible oxygen enriched environment The patient trigger PCB interfaces with the main processor PCB via a 20 way head Communication between the two PCB s is via a CAN bus The main processor PCB also supplies 5 V power to this PCB and monitors othe...

Page 33: ...Service Manual 23 675 120 Rev G Electrical Layout Figure 8 shows the electrical wiring and PCB connector layout Figure 8 IFSD Electrical Wiring Diagram ...

Page 34: ...nality FiO2 CmH2O NCPAP NCPAP Apnea BiPhasic Apnea BiPhasic Tr Fault lockout screen shows error code s Unit inoperable by software operable in unpowered ti X X X X X X Error code s shown on mode selection screen Status bar mode alternates Unit restricted to NCPAP and NCPAP Apnea modes X X Error code s shown on mode selection screen Status bar mode lt t Patient trigger NCPAP Apnea BiPhasic Apnea an...

Page 35: ...pply cable to a suitable power supply outlet The green power light will come on regardless of the position of the power switch 3 Connect the patient circuit to the IFSD as required Figure 9 shows a typical configuration the actual configuration may vary dependent on the type of ancillary equipment used and the clinical needs prescribed for the patient For functional test purposes the Generator nas...

Page 36: ... Model M675 675 120 Rev G Figure 9 Patient Connections WARNING Check that the water trap is empty before use and empty it frequently during use Infant Flow LP Generator or Generator Infant Flow LP SiPAP Driver or SiPAP Driver ...

Page 37: ...provide superior NCPAP The IFSD is subject to a direct relationship between controlled enriched gas flow and NCPAP pressure Nomograms illustrating the relationship between constant airway pressure and flow settings are shown in Figure 10 and Figure 11 Example 8 LPM gas flow provides 5 cm H2O NCPAP Verify the type of IFSD you are using LP SiPAP or 675 CFG XXX to determine which nomogram to use Note...

Page 38: ...P SiPAP Individual devices have a tolerance of up to 15 percent from that illustrated in the nomogram and in particular at pressures below 2cmH2O Flow Pressure Nomogram for reference only to show typical flow pressure relationships This is not meant to establish actual product performance ...

Page 39: ...ng bar goes off and the screen changes to the Power Up Screen After two seconds the screen changes to the Power Up Check Screen During the power up checks the screen image is shown in negative the warning bar comes on for one second the Apnea light comes on for one second the audible alarm sounds for one second the dump valve is tested the pressure is set to zero After two seconds the screen chang...

Page 40: ...dicators Test and calibration of pressure sensor Test of dump valve The unit carries out a full functional check during this time If unsuccessful the screen remains darkened and the warning bar remains on In this case check for the following Power Supply not connected Battery voltage low If the checks are successful the screen changes to Power Up Screen After two seconds the screen changes to Powe...

Page 41: ... O2 button This will disable oxygen monitoring and the audible oxygen alarms until the device is powered off Whenever the device is operating with oxygen monitor and alarms disabled a fault code E55 displays and measured FiO2 displays as dashes WARNING When the Infant Flow LP SiPAP system unit or SiPAP system unit part number 675 CFG xxx is connected to a patient and the internal oxygen monitor is...

Page 42: ...prescribed for the current patient Verify that the blender setting and the measured oxygen value are within 3 Touch the associated flashing screen icon to confirm 6 Adjust the Pres High Flowmeter as prescribed for the current patient Touch the associated flashing screen icon to confirm 7 If desired connect the Transducer Interface to the front panel of the driver if breath monitoring is required d...

Page 43: ...ed above 1 Make appropriate connections for air and O2 gas supply Connect power cord to appropriate AC outlet Attach patient circuit generator and patient interface mask or prong as shown in Figure 3 Occlude the opening to the patient 2 Power up the driver and allow Power On Check to complete 3 Low airway pressure alarm From NCPAP operating mode with alarms set remove occlusion from opening to pat...

Page 44: ... Alarm Mute Silence button for three seconds to reset the alarms Note If staff is using a transducer P N 677 002 for Apnea Monitoring proceed to step 9 If staff is not using a transducer mark N A on checkout sheet and testing is finished 9 Low Breath Rate Apnea Alarm Attach the transducer and abdominal sensor to the unit Set Mode to BiPhasic Apnea LBR U S Configuration or Biphasic LBR rate 30 Bpm ...

Page 45: ...ests Power On Check Manual Tests Two Point O2 Sensor Calibration Patient Circuit Leak test Manual Alarms Checks Low Airway Pressure Alarm High Airway Pressure Alarm High O2 Alarm Low O2 Alarm Loss AC Alarm High Circuit Pressure Alarm Low Breath Rate Apnea Alarm Signature of tester _______________________________________________ Title___________________________________________________________ ...

Page 46: ...ctivated the button displays a flashing cross The alarm condition must be cleared before the setting is confirmed refer to Table 1 WARNING The indicates a connection between the transducer interface and the unit It does not indicate correct positioning of the abdominal respiratory sensor Note All triggered modes NCPAP Apnea BiPhasic Apnea BiPhasic Tr are automatically confirmed with a if the patie...

Page 47: ...nds to unlock the key pad The display returns to the Mode Selection Screen Note If a high priority alarm occurs the keypad automatically unlocks Setting the NCPAP Parameters For NCPAP Apnea function the transducer interface and the abdominal respiratory sensor must be connected From the Mode Select Screen touch the NCPAP Apnea button The screen changes to the Parameter Set Up Screen and shows The ...

Page 48: ...rface is connected to the unit is displayed and BiPhasic Apnea monitoring mode is enabled In addition to the above parameters the screen shows The detected breath bar graph The detected breath rate Rsp The delay time for the alarm to come on Tapnea Push the individual buttons to select between the parameters T High Rate and Tapnea Use the buttons to set the parameter for T High Rate and Tapnea Not...

Page 49: ...creen Note If a high priority alarm occurs the keypad automatically unlocks Setting the Triggered BiPhasic Parameters From the Mode Select Screen touch the BiPhasic Tr button Note The transducer interface must be connected to enter this mode The screen changes to the Parameter Set Up Screen and shows The patient s respiration rate Rsp The NCPAP Pres high inspiration time T High The NCPAP Pres high...

Page 50: ...n alarm condition occurs If this occurs the button cannot be operated until the alarm condition has been cleared or silenced using the alarm button After two minutes if the Operator has not made any inputs the screen changes to the Locked Screen The key pad is locked The display remains as shown for patient monitoring Touch the button to unlock the key pad The display returns to the BiPhasic Tr Ad...

Page 51: ...te If the calibration procedure fails a red is shown in the applicable button Re calibrate and if necessary replace the O2 fuel cell Giving a Manual Timed Sigh In the Mode Select or Adjust screens of NCPAP Apnea BiPhasic Apnea or BiPhasic Tr touch the button to give the patient a manual timed sigh Operation Without Electrical Power The IFSD can be used without mains or battery power To use the IFS...

Page 52: ... software and prevents the unit from operating correctly the screen changes to the Fault Lockout Screen All functions and controllable inputs are disabled but the unit can still be used without electrical power The related fault code numbers are shown on the screen The alarm bar comes on and the predominant fault code number is shown in the status bar If an error code is shown refer to the Service...

Page 53: ...ighted Alarm Button flashes Dump valve actuated for three seconds to stop flow to patient and repeated until flow returns to normal Reduce pressure to below the high pressure limit then push the Alarm Button for three seconds High oxygen concentration 5 FiO2 above set point at time alarm is set for 15 seconds or 104 FiO2 for 15 seconds Set automatically on entering NCPAP mode for the first time af...

Page 54: ...AP mode for the first time after start up or by pushing the alarm button for three seconds at any time Intermittent high level Audible Alarm Warning Bar flashes Pressure display flashes Digital pressure high limit is highlighted Alarm Button flashes Push the Alarm Button once to stop the audible alarm for 30 seconds Alarm Button flashes digital pressure high limit stays highlighted Warning Bar sti...

Page 55: ...essure display flashes Digital high MAP pressure limit is highlighted Alarm Button flashes Push the Alarm Button once to stop the Audible Alarm for 30 seconds Alarm Button flashes digital high MAP pressure limit stays highlighted Warning Bar still flashes Push the Alarm Button for three seconds to reset the limit alarms clear Low battery charge 40 Automatic Battery status indicator changes from gr...

Page 56: ...nce to stop the audible alarm The Warning Bar stops flashing and the battery status indicator is displayed Reconnect the external power Software fault Automatic Intermittent high level Audible Alarm Warning Bar flashes intermittently Screen displays flashing fault code E number Cannot be reset Refer to Service Engineer Software not running with unit connected to power Automatic Constant Audible Al...

Page 57: ...le sigh is given In BiPhasic Tr Mode backup sighs at the set rate are given Alarm Button flashes The timer is reset and the applicable sigh function is repeated until breathing restoration is detected or the Operator intervenes Push the Alarm Button once to stop the Audible Alarm for 30 seconds Alarm Button flashes breath rate icon and digital display still flashes Warning Bar still flashes in BiP...

Page 58: ...t circuit and connect the circuit to the unit and the occlude prongs Adjust the nCPAP Flowmeter until pressure reads 10 cm H2O 0 2 cm H2Oon the external pressure gauge and touch the second key to calibrate at 10 cm H2O To return to the Diagnostics Menu Screen touch the button Press to carry out an oxygen calibration The diagnostic main screen stays the same and the key pad at the bottom of the scr...

Page 59: ...ive action has been taken to clear all faults press the button Table 6 Error Codes Error Code Fault Condition Consequence Software Response Corrective Action Program memory checksum error Unusable Software corrupt execution inhibited Hardware held in permanent reset condition with Warning Bar on Reload software Battery too discharged 6 5 V to operate LCD analogue and valve driver circuits no exter...

Page 60: ...d if required Put the unit into diagnostics mode clear the E12 error then return to normal mode E20 Charged battery voltage too low 11 V when under test load No backup battery capacity low Battery fault icon flashes and Error number alarm prompt Replace the battery E21 External supply voltage too low 14 V to charge battery battery flat No backup battery will not charge Battery low alarm continues ...

Page 61: ...or PCB and re calibrate O2 and pressure sensors E32 Zero valve activation fault via sense Unusable pressure sensor readings unreliable User lockout Error number prompt Replace the Valve Sensor PCB and re calibrate O2 and pressure sensors E33 Unable to auto zero pressure sensor Unusable pressure sensor readings unreliable User lockout Error number prompt Replace the Valve Sensor PCB and re calibrat...

Page 62: ...lender gas supplies or circuits E52 Oxygen sensor calibrates but the fuel cell is worn out low gain No oxygen monitor oxygen sensor readings unreliable E52 displayed high priority alarm Replace the O2 fuel cell and re calibrate the O2 sensor E53 Oxygen sensor too noisy to calibrate calibration timeout No oxygen monitor oxygen sensor readings unreliable E53 displayed high priority alarm Replace the...

Page 63: ...t report Apnea Untriggerable Patient may be in Apnea but PT module may be dysfunctional Reduced functionality Error number alarm prompt Contact CareFusion technical support E72 No trigger signal from PT module in BiPhasic Tr mode Untriggerable No BiPhasic Tr treatment given to patient Reduced functionality Error number alarm prompt Contact CareFusion technical support E90 Spurious software interru...

Page 64: ...ev G Error Code Fault Condition Consequence Software Response Corrective Action E99 Unknown error detected Unusable software unreliable User lockout Error number prompt Contact CareFusion technical support Generated as a consequence of the fault ...

Page 65: ...nual PM Kit and blender overhaul Annual PM Kit and Low Flow MicroBlender Overhaul Kit P N 10003 required 3 Five Year PM Placement Five Year PM Kit P N 777242 103 Contents include annual PM kit and Valve Sensor PCB PM Procedure 1 Replacement of designated parts 2 User Verification Test UVT 3 Oxygen Leak Test Tools Required 1 Phillips Screwdriver 2 Phillips Screwdriver Flathead Screwdriver Pliers Ci...

Page 66: ...ior of the case for damage and dirt If necessary clean the unit 2 Check the water trap on the back panel If water is visible in the water trap push the button on the bottom of the water trap to release the water 3 Technical Assistance can be obtained from the offices listed at the beginning of this manual 4 Store the unit in a clean dry location Make sure that the connections and ports are suitabl...

Page 67: ...umber Components Removal Directions Page Number 777244 Battery 60 06804 Oxygen Filter 61 465474 Banjo Screw O Ring 61 672 024 SA 465474 465457 Fuel Cell Filter Restrictor and O rings 62 68289 O2 Sensor 63 465476 O Ring on Front Panel 64 65 Steps 1 12 467269 Water Trap Filter 68 675 230 Pilot Drive Check Valves 68 467542 Case Bleed Filtered Restrictor 69 11507 Muffler Filter 70 ...

Page 68: ...tion Page Number 11329 or 11798 Blender 64 67 10003 Low Flow MicroBlender Overhaul Kit L1130 Low Flow MicroBlender Service Manual 777242 101 Annual PM Kit See Table 7 Table 9 shows the fiver year PM components and page number references Table 9 Five Year PM Components Part Number Component Removal Direction Page Number 777242 101 Annual PM Kit See Table 7 52700A Valve Sensor PCB 70 ...

Page 69: ...in frame making sure that all wires and tubing are secure and cannot be trapped by the case 2 Install the ten screws 1 on the rear panel and tighten 3 Carry out an Oxygen Leak check see Appendix A on page 75 and functional check of the IFSD Note An Oxygen Leak test must be done after every service that requires removal of the case to ensure no buildup of oxygen is present within the case Figure 12...

Page 70: ...the battery 5 Disconnect the positive and negative leads from the battery Make note of where each lead goes Note Exhausted batteries and oxygen fuel cells both contain lead and must be disposed of according to local regulations Fitting 1 Feed the battery lead through the frame to plug PL3 on the Main Processor PCB 2 Reconnect positive and negative leads to battery CAUTION Verify that the leads are...

Page 71: ...ure 14 Removal 1 Remove the banjo screw 1 on the end of the air oxygen mounting block 2 2 Remove the filter 3 3 Remove and discard the O ring 4 Fitting 1 Install a new O ring P N 465476 4 on the banjo screw 1 2 Install a new filter P N 467464 3 in the air oxygen mounting block and install the banjo screw 1 3 Tighten the banjo screw 1 Figure 14 Oxygen Filter Removal Fitting ...

Page 72: ...ixer block 2 Remove the filter restrictor 3 Remove and discard the O ring 4 and the O ring 5 from the oxygen filter screw 1 Fitting Install a new O ring P N 465474 5 on the oxygen filter screw 1 Install a new O ring P N 465457 4 and the filter restrictor P N 672 024 SA 3 into the flow mixer block 2 Install the oxygen filter screw 1 and tighten Figure 15 Oxygen Filter Restrictor Removal Fitting ...

Page 73: ...at the top of the oxygen sensor to remove it The leak compensation tubing 6 can also be disconnected from the elbow to gain access 5 Discard the oxygen sensor 4 and attached O ring Note Exhausted batteries and oxygen sensor both contain lead and must be disposed of according to local regulations Fitting 1 Check the expiration date of the new sensor Remove the O2 Sensor P N 68289 from the sealed pa...

Page 74: ...the case 2 Remove the battery 3 Disconnect the connector SK1 1 on the LED PCB 4 Disconnect the connector PL5 2 on the Main Processor PCB 5 Disconnect the connector at PL2 3 on the Patient Trigger PCB 6 Remove the input connection tube 4 by pulling the elbow off the 1 8 silicone tube taking care not to break the barbs on the elbow Note There are trwo types of blender knobs used on the LP SiPAP P N ...

Page 75: ...emove the Valve Sensor PCB 13 as follows a Disconnect the fuel cell connector SK1 14 at PL1 on the Valve Sensor PCB b Disconnect the dump vent valve connector SK3 15 at PL3 on the Valve Sensor PCB c Remove the five screws 16 d Pull the Valve Sensor PCB 13 downwards and out forward to disconnect the PCB from the D plug PL2 e Disconnect the exhaust tubes from the back of the PCB and the PA flow tube...

Page 76: ...66 Infant Flow LP SiPAP Model M675 675 120 Rev G Figure 17 Blender and Components Removal Fitting ...

Page 77: ...e connector SK3 15 at PL3 on the Valve Sensor PCB 4 Fit the front panel assembly 11 and install the eight screws 10 5 Set the FiO2 collet on the blender to the 21 position Align the control knob 7 so that the pointer is in the 21 position and install the control knob For P N 467472 install the cover 6 6 Install the NCPAP Pres low and NCPAP Pres high flow control knobs 9 on the spindles Using a scr...

Page 78: ...Valves Removal 1 Locate the pilot valve check valve behind the NCPAP flowmeter 2 Cut the cable tie securing the valve to the flowmeter 3 Remove the pilot drive check valve from tubing and discard 4 Locate the pilot drive check valve behind the Pressure High Flowmeter 5 Cut the cable tie securing the valve to the flowmeter 6 Remove the pilot drive check valve from tubing and discard Fitting 1 Insta...

Page 79: ...strictor to sheet metal 2 Note restrictor flow direction then remove the case bleed filtered restrictor 3 from the 4mm tube 3 Discard the case bleed filtered restrictor 3 Fitting 1 Install the new case bleed filtered restrictor P N 467542 3 to the tube in the proper orientation 2 Re secure the restrictor to the sheet metal Figure 18 Water Trap Filter Removal Fitting ...

Page 80: ...k of the PCB and the flow tube and remove the Valve Sensor PCB Fitting 1 Connect the exhaust tubes to back of PCB and PA Flow tube 2 Fit the Valve Sensor PCB 13 into the D plug PL2 3 Fit the five screws 16 4 Connect the fuel cell connector SK 14 at PL1 on the Valve Sensor PCB 5 Connect the dump vent valve connector to SK3 15 at PL3 on the Valve Sensor PCB Removal and Fitting of the Muffler Filter ...

Page 81: ... IEC 30878 The equipment is suitable for alternating current Symbol 5031 IEC 60417 This symbol indicates DIRECT CURRENT DC Symbol 5019 IEC 60417 Symbol 01 20 IEC 60878 This symbol indicates protective EARTH ground Symbol 5021 IEC 60417 Symbol 01 24 IEC 60878 This symbol indicates the EQUIPOTENTIAL connection used to connect various parts of the equipment or of a system to the same potential not ne...

Page 82: ... 60878 This symbol indicates TYPE B equipment which indicates equipment that provides a particular degree of protection against electric shock particularly with regards to allowable leakage current and reliability of the protective earth connection Type BF patient applied part Year of Manufacture Unique Batch Number Identifier Use Before Expiry Date shown Year Month Single Use Only Do NOT Re use K...

Page 83: ...lumn Symbol Description High Priority Alarm Active Medium Priority Alarm Active Low Priority Alarm Active medium and high priority alarms are resolved Alarm does not flash No alarms active or resolved are present Active alarm silenced Adjust BiPhasic rate Adjust BiPhasic Tr backup rate Adjust apnea alarm timeout Adjust low breath rate alarm timeout Adjust BiPhasic BiPhasic Tr on time and NCPAP man...

Page 84: ...reath cycle is delivered regardless of button press duration Toggle between Main Screen and Monitored Parameter Screen Go to user calibration mode screen Confirm Wait Completed Action has failed Press to un lock keypad Warning message To clear press any of the three icons Note Provision of labeling in this manual for any function should not be taken as evidence that the function is available For e...

Page 85: ...en analyzer sampling tube to the driver by replacing the M6 pan screw with an M6 fitting Before operating the driver take an initial O2 concentration reading Plug the fitting 3 Attach circuit and generator with prongs to unit Switch the power on 4 Press the Cal Icon on the touch screen and do a 2 point calibration of the O2 sensor Figure A 1 5 Set the NCPAP Low Pressure Flowmeter to about 8 LPM or...

Page 86: ...soft key button under the right Flowmeter icon The Respiratory Sensor option is not required but to finish select this soft key button 8 Accept the NCPAP settings by selecting the NCPAP soft key O2 should display 100 Figure A 2 Figure A 2 9 The next screen varies but select BiPhasic soft key Figure A 3 Figure A 3 ...

Page 87: ...cting the BiPhasic soft key again Figure A 4 Figure A 4 11 Verify that the measured value on the external oxygen analyzer doesn t exceed 23 FiO2 If so then troubleshoot for an oxygen leak Check all the fittings and connections and repeat the Oxygen Leak Test Figure A 5 Figure A 5 ...

Page 88: ...78 Infant Flow LP SiPAP Model M675 675 120 Rev G Infant Flow LP SiPAP and SiPAP Model M675 ...

Page 89: ...b rate settings to maintain a minimum off time of 100 milliseconds US Configuration Parameters Parameter Min Max Accuracy Units Inspired oxygen fraction FiO2 21 100 3 CPAP flow rate 0 15 15 LPM Bi level additional flow rate 0 5 15 LPM BiPhasic on time T High inspiration time 0 1 3 0 0 005 seconds BiPhasic rate R respiration rate 1 54 0 5 Pm Breath rate timeout 10 30 1 Seconds T High automatically ...

Page 90: ...80 Infant Flow LP SiPAP Model M675 675 120 Rev G Infant Flow LP SiPAP and SiPAP Model M675 ...

Page 91: ...ION PAD 465464 FILTER WATERTRAP 673 051 A WATERTRAP TOOL 465476 O RING PATIENT CONNECTOR 672 024 SA ASSEMBLY FILTER 465457 O RING O2 SCREW FLOWMETER GAS BLOCK 465474 O RING O2 FILTER 68289 FUEL CELL 675 230 PILOT DRIVE DUCKBILL ASSY 467542 CASE BLEED FILTER RESTRICTOR 52700A VALVE SENSOR PCB 467459 FUSE TIME LAG 2 5A 250V 467458 POWER INPUT TWIN FUSE 675 307 AUX FLOW MOUNTING BLOCK 11798 ASSY BLEN...

Page 92: ...2 101 SERVICE KIT Mk3 DRIVER ANNUAL 777242 103 SERVICE KIT Mk3 DRIVER 5 YEAR 777072 101 ASSY O2 AIR FITTINGS MARK III DISS 777072 102 ASSY O2 AIR FITTINGS MARK III NIST 777072 103 ASSY O2 AIR FIT MARKIII FEMALE DISS 777072 103 ASSY O2 AIR FIT MARKIII AIR LIQUIDE 461964 CABLE TIE BATTERY 52000 00239 CABLE TIE CHECK VALVE ASSEMBLY 11431 ASSEMBLY AUXILLIARY FLOWMETER 11329 ASSEMBLY BLENDER MANUFACTUR...

Page 93: ...Service Manual 83 675 120 Rev G Appendix D Pneumatics Assembly ...

Page 94: ...84 Infant Flow LP SiPAP Model M675 675 120 Rev G ...

Page 95: ... time cycled BiPhasic Apnea BiPhasic Ventilation with Apnea monitoring non US labeling BiPhasic LBR BiPhasic with low breath rate monitoring US labeling BiPhasic Tr Triggered BiPhasic Ventilation CPAP with additional pressure pulses patient triggered and time cycled NCPAP Nasally applied CPAP NCPAP LBR NCPAP with Low Breath Rate monitoring US labeling NCPAP Apnea NCPAP with Low Breath Rate monitor...

Page 96: ...BR monitor alarm time US labeling both in seconds This mnemonic may also be associated with an alarm icon T High Machine breath inspiration time seconds Treatment Application of NCPAP BiPhasic BiPhasic Tr with or without breath monitoring to the patient US labeling Labeling using English text in place of symbols and or icons ...

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