Service Manual ® Infant Flow SiPAP Model M675 © Copyright 2005, VIASYS Healthcare Respiratory Care 675-120 Revision D May 2005
675-120 Infant Flow® SiPAP Revision D May 2005
Service Manual Revision History Date Revision Pages Changes September 2003 675-120(1) All Release November 2004 B All Release manual in VIASYS Healthcare template using VIASYS Healthcare Respiratory Care nomenclature. December 2004 C Title page, 19, 30, 39, 45, 50, 56, 57, 61, 62, 64, 65, 68, 69, 73, 75, 81–83, 86, 87, 88 May 2005 D Revised per EO 27980. Removed the picture from the title page. Deleted the ESD warning from page 19.
Infant Flow® SiPAP Contact and Ordering Information United States, Latin America, Asia Pacific: Sales, Service and Clinical Support: VIASYS Healthcare Respiratory Care 22745 Savi Ranch Parkway Yorba Linda, CA 92887 Phone: (714) 283-8444 (800) 381-3552 Fax: (714) 283-8493 www.VIASYShc.com United Kingdom: Sales, Service and Clinical Support: VIASYS Healthcare 3 Welton Rd.
Service Manual Warranty The Infant Flow® SiPAP is warranted to be free from defects in material and workmanship and to meet the published specifications for One (1) year from date of shipment.
Infant Flow® SiPAP Contents Revision History.................................................................................... 3 Contact and Ordering Information ...................................................... 4 Warranty ................................................................................................ 5 Limitation of Liabilities ................................................................................................... 5 Contents .........................................
Service Manual Preparing and Connecting the Equipment................................................................... 36 Setting Up the Equipment............................................................................................ 40 Setting the NCPAP Parameters................................................................................... 41 Setting the BiPhasic Parameters .................................................................................
Infant Flow® SiPAP Notices Copyright Notice Copyright © 2004 VIASYS Healthcare, Respiratory Care, California. This work is protected under Title 17 of the U.S. Code and is the sole property of the Company. No part of this document may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specifically permitted under U.S. Copyright law, without the prior written consent of the Company.
Service Manual With regards to Electrical Safety: Class 1 equipment Contains type BF patient applied parts Continuous Operation MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate this device in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the device.
Infant Flow® SiPAP Declaration of Conformity Notice This medical equipment complies with the Medical Device Directive, 93/42/EEC, and the following Technical Standards, to which Conformity is declared: Council Directive(s): MDD 93/42/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.
Service Manual 675-120 Revision D May 2005
Infant Flow® SiPAP Chapter 1 - Product Description The Infant Flow® SiPAP is a non-invasive form of respiratory support designed for use in hospital environments such as Neonatal and Pediatric Intensive Care Units. It can also be used when transporting patients within the hospital environment. The Infant Flow® SiPAP is currently available in a Plus or Comprehensive configuration. The Plus configuration provides NCPAP and time triggered, BiPhasic modes with and without breath rate monitoring.
Service Manual Screen Lock - After 120 seconds of no screen inputs, the screen changes to the Locked Screen to prevent inadvertent changes. Upon activation of a high priority alarm the screen changes to an unlocked state to allow for immediate interventions as required.
Infant Flow® SiPAP Chapter 2 - Product Specifications Modes • NCPAP • NCPAP with breath rate monitoring and low rate alarm • BiPhasic (time triggered) • BiPhasic (time triggered) with breath rate monitoring and low rate alarm • BiPhasic tr (patient triggered ) with breath rate monitoring, low breath rate alarm, and apnea back up Controls • Inspiratory Time (Ti) – 0.1-3.
Service Manual Alarms • High airway pressure – 3 cmH20 above measured airway pressure • High circuit pressure – maximum 11 cmH20 in time triggered Biphasic mode • High circuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr* mode • Low airway pressure – 2 cmH20 below measured airway pressure or 1 cmH20 if otherwise would be zero • High and Low delivered Oxygen concentration +5% of setting • Low breath rate alarm • Low or Flat battery charge level • Input gases failure • Al
Infant Flow® SiPAP Atmospheric & Environmental • Temperature Range-Operating: 5 – 40° C • Storage: 0 - 50° C • Relative Humidity -Operating: 0 – 90% non-condensing • Storage: 0 – 90% non-condensing Physical 675-120 • 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.
Service Manual 675-120 Revision D May 2005
Infant Flow® SiPAP Chapter 3: Summary of Warnings and Cautions Please review the following safety information prior to operating the Infant Flow® SiPAP. Attempting to operate this equipment without fully understanding its features and functions may result in unsafe operating conditions. Warnings and Cautions, which are general to the use of the device under all circumstances, are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful.
Service Manual 675-120 • When filling a humidifier, do not move the stand. Moving or transporting the stand while refilling may cause the stand and equipment to over balance. • Do not use conductive patient circuits with the Infant Flow SiPAP Driver. • Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and pressure necrosis. Observe the usage guidelines to minimize these complications. • This device exhausts O2 during normal operation.
Infant Flow® SiPAP Cautions 675-120 • Federal Law (USA) restricts this device to sale by or on the order of a physician. • The precision gas blender in this product may become non-functional or damaged if used without the protective water trap and filters provided. • The power switch on this unit does not isolate the external power supply. Disconnect the power supply cable to ensure complete isolation. • Before use, verify that this equipment has been authorized for use by a qualified person.
Service Manual 675-120 Revision D May 2005
Infant Flow® SiPAP Chapter 4: System Construction CAUTION Where the integrity of the external protective earth conductor is in doubt the equipment shall be powered by its internal power source (battery). The IFSD is AC powered with an integral rechargeable DC battery that provides power for up to two hours without any interruption of performance 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.
Service Manual Figure 1 - IFSD Front Panel Gas Module The function of the gas module is to take air and oxygen, blend them into the required mixture and deliver this mixture to the patient at the prescribed flow rate. The gas module also measures the oxygen concentration, measures the patient pressure, provides an auxiliary gas outlet (optional) and provides switched Biphasic flow.
Infant Flow® SiPAP Electronics Module The function of the electronics module is to power the unit either by AC mains supply or DC emergency battery supply, to control the gas module and 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.
Service Manual Figure 3 -IFSD Internal Components 675-120 Revision D May 2005
Infant Flow® SiPAP Front Panel Module The function of the front panel module is to house the gas and electrical connections to the patient, Operator controls and indicators. The module consists of a front panel plate, the touch screen with key pad, flowmeters and FiO2 control, patient connectors and indicators and an ambient light sensor. The backlight on the touch screen is decreased if the ambient light sensor detects a low ambient light level and increased if it detects a high ambient light level.
Service Manual alarm condition, the button is solid yellow with an audible alarm. If any alarm condition resets itself, the yellow alarm bar remains to alert the clinician of a previous problem. Caution/Information The Caution/Information icon alerts the Operator to read this manual. It flashes during 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).
Infant Flow® SiPAP • an audible Whistle which sounds a constant tone when the gas imbalance limits are exceeded. • an audible Alarm which sounds a constant tone or 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.
Service Manual Table 2 - Diagnostics Screen Boxes Box DIPS CONTRAST INDICATOR CALIBRATION INDICATOR Description The DIPS box shows the position of the DIP switches on the main processor PCB. Position 1 is on and O is off. The contrast indicator box is for use in the factory for setting the screen contrast. The calibration indicator box shows successfully completed and a The following display boxes show when if the calibration fails.
Infant Flow® SiPAP Chapter 5 - Operation Gas Flow With the oxygen and air connections connected and the power switched on, oxygen and air at 386 kPa (56 psig) flows to the blender. The air passes through a water trap with an integral filter where any moisture in the air is removed. Oxygen and air are filtered before entering a non-return valve in the blender. The blender mixes the oxygen and air in the proportion set by the position of the FiO2 control valve. The blender supplies blended gas between 2.
Service Manual Figure 6 - IFSD Gas Flow Schematic The patient pressure is shown on the touch screen and is monitored by a pressure sensor which sends the signal to the main processor. A zeroing valve automatically checks the pressure readings against atmospheric pressure to ensure accuracy of the patient pressure readings. A mechanical pop-off valve is factory set to limit the delivered pressure to a safe level sufficient to achieve the maximum required patient pressure at the generator.
Infant Flow® SiPAP WARNING The NCPAP Pres high must be adjusted to zero when not required for the patient. Triggered BiPhasic For BiPhasic Tr, a micro controller provides reliable indications of breaths derived from the patient abdominal respiratory sensor. It sends signals to operate the NCPAP Pres high valve to provide a timed sigh. WARNING Under extreme conditions (minimum supply pressure and maximum gas demand, including auxiliary output) output flow rates may reduce.
Service Manual Figure 7 - IFSD Electronic Enclosure Electrical Layout Figure 8 shows the electrical wiring and PCB connector layout.
Infant Flow® SiPAP Fault Management When a software detectable fault condition occurs, the unit still allows a basic level of treatment to the patient. Table 4 shows the fault conditions and the level of control available. Table 4 - Faults, Available Modes and Control Functions Measurements Alarm Fault lockout screen shows error code(s). Error code(s) shown on mode selection screen. Status bar mode alternates with Error code(s) shown on mode selection screen.
Service Manual 675-120 Revision D May 2005
Service Manual Chapter 6 - Operation The operating procedures below show the procedures for all models. Reference should only be made to the procedures for the model in use. Read the Warnings and Cautions at the beginning of this manual before you start the procedures. Preparing and Connecting the Equipment WARNING Ensure the whistle sounds during gas connection, if not the device may be faulty and should not be used.
Service Manual Figure 9 - Patient Connections WARNING Check that the water trap is empty before use and empty it frequently during use.
Infant Flow® SiPAP 5 Make sure that the water trap is empty. If necessary, empty any water from the trap (refer to Chapter 3, Maintenance). 6 Gas Flow Pressure Setting The IFSD provides a virtually constant airway pressure irrespective of patient demand or expiratory flows via the specially designed generator and nasal prongs. This is the reason for the IFSDs ability to provided superior NCPAP. The IFSD is subject to a direct relationship between controlled enriched gas flow and NCPAP pressure.
Service Manual Switching On the IFSD WARNING Do not attach the Generator to the patient until the initial set up is complete. Put the power switch on the back panel to the • the warning bar comes on • the green power light remains on • the audible alarm sounds position. The unit carries out a full functional check. If the checks are not successful (program memory fault, power supply not connected or emergency battery voltage low), the screen remains black and the warning bar stays on.
Infant Flow® SiPAP Setting Up the Equipment The procedures show the screen set up for all modes. If a mode is not applicable to the model in use, go to the next applicable step. Adjust the NCPAP Pres low flowmeter to indicate the required flow rate. When done, touch the flashing button to confirm the initial setting The button icon changes to a and the next button starts flashing. Set the FiO2 and NCPAP Pres high flow as appropriate, touching the confirm each time.
Service Manual When the alarm limits have been set, the screen changes to the Mode Selection Screen and defaults to the nCPAP mode. • the alarm limits are set Touch NCPAP, NCPAP+Apnea, BiPhasic, BiPhasic+Apnea, or BiPhasic Tr to enter the Parameter Set up Screen for each mode. Note When the Mode Selection screen is showing, NCPAP treatment will always be delivered. After two minutes if the Operator has not made any inputs, the screen changes to the Locked Screen.
Infant Flow® SiPAP Note If a high priority alarm occurs, the key pad automatically unlocks. To return to the Mode Selection Screen, touch the button. Setting the BiPhasic Parameters For BiPhasic+Apnea function the transducer interface and the abdominal respiratory sensor must be connected. From the Mode Select Screen touch the Biphasic button.
Service Manual Parameters Ti and Rate can now be adjusted. Note The I/E rate changes accordingly. To return to the Mode Selection Screen, touch the button. Note The button is shown with a pink background if an 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.
Infant Flow® SiPAP Confirm the BiPhasic Tr settings by touching the flashing BiPhasic Tr button. When the settings have been accepted, the screen changes to the locked screen and treatment starts. To adjust the parameters, touch the button. The screen changes to the BIPHASIC TR Adjust Screen. Parameters Ti, Rb and Tapnea can now be adjusted. To return to the Mode Selection Screen, touch the button. Note The button is blank if an alarm condition occurs.
Service Manual Touch the button. The screen returns to the Start Up Screen . Note If the calibration procedure fails, a red is shown in the applicable button. Recalibrate 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.
Infant Flow® SiPAP • 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 Manual or contact your Service Engineer to rectify the faults. Over Pressure Indications If an over pressure occurs, the software opens the dump valve to release the pressure.
Service Manual Indications and Actions Method of Resetting or Canceling Set automatically on entering NCPAP 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. O2 digital display flashes. Digital O2 alarm high limit is highlighted. Alarm Button flashes.
Infant Flow® SiPAP Indications and Actions Method of Resetting or Canceling Set automatically on entering NCPAP 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 low limit is highlighted. Alarm Button flashes.
Service Manual Indications and Actions Method of Resetting or Canceling Automatically constantly monitored with the power switch in the on position with no external power connected. Intermittent medium level Audible Alarm. Warning Bar flashes intermittently. Battery status indicator flashes. Unit starts a controlled shut down at a set limit. Push the Alarm Button once to stop the Audible Alarm for three minutes (Alarm Button flashes, battery status indicator stays flashing).
Infant Flow® SiPAP Indications and Actions Method of Resetting or Canceling Automatic Constant Audible Alarm. Warning Bar on. Screen displays flashing fault code (E number). Cannot be reset. Refer to Service Engineer. Blender whistle Water trap blocked, full or leaking; filters blocked; loss of wall pressure; imbalance of wall gas supply. Audible Alarm. Refer to Service Engineer. Oxygen cell calibration error.
Service Manual Indications and Actions Method of Resetting or Canceling Set automatically on entering BiPhasic Tr, NCPAP + Apnea or BiPhasic +Apnea modes if patient trigger is installed and selected. Intermittent high level Audible Alarm. Warning Bar flashes. Breath rate digital display flashes. Breath rate icon flashes. In BiPhasic models with monitored NCPAP + Apnea, a single sigh is given. In BiPhasic Tr Mode backup sighs at the set rate are given. Alarm Button flashes.
Infant Flow® SiPAP Diagnostics Diagnostic mode is accessed by enabling DIP switch 6 and exited by disabling it. Enable DIP switch 6 during Start Up, Adjust or Mode Selection. The screen changes to the Diagnostics Menu Screen (for a description of the displayed information refer to paragraph 1.2.
Service Manual Figure 11 – Security Screen To return to the Diagnostics Menu Screen, touch the Select button. to carry out a valve test The diagnostic main screen stays the same and the key pad layout changes. Touch the first key to test the zero valve, the second key to test the dump valve and the third key to test the PA valve. To return to the Diagnostics Menu Screen, touch the button.
Infant Flow® SiPAP Table 6 - Error Codes Error Code Software Response Corrective Action 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 external power). Unusable - no user interface display. Hardware held in reset condition with Warning Bar (status LED off) on until external power applied. Plug in external power.
Service Manual Error Code Software Response Corrective Action Fault Condition Consequence E20 Charged battery voltage too low (<11 V) when under test load. No backup – battery capacity low. E21 External supply voltage too No backup – battery will Battery low alarm Replace the low (<14 V) to charge not charge. continues even PSU module. battery (battery flat). when external power applied. ‘Error number’ alarm prompt. E22 Analog supply rails out of limits.
Error Code Infant Flow® SiPAP Fault Condition Consequence Software Response Corrective Action E32 Zero valve activation fault (via sense). Unusable – pressure sensor readings unreliable. User lockout ‘Error number’ prompt. Replace the pneumatics PCB and recalibrate O2 and pressure sensors. E33 Unable to auto zero pressure sensor. Unusable – pressure sensor readings unreliable. User lockout ‘Error number’ prompt. Replace the pneumatics PCB and recalibrate O2 and pressure sensors.
Service Manual Error Code Fault Condition Consequence Software Response Corrective Action E52 Oxygen sensor calibrates Unusable – oxygen but the fuel cell is worn out sensor readings (low gain). unreliable. User lockout ‘Error number’ prompt. Replace the O2 fuel cell and recalibrate the O2 sensor. E53 Oxygen sensor too noisy to calibrate (calibration timeout). User lockout ‘Error number’ prompt. Replace the O2 fuel cell and recalibrate the O2 sensor.
Error Code Infant Flow® SiPAP Software Response Corrective Action Spurious – software interrupted and restarts (possibly during treatment). Hardware reinitialized (disabled) with alarm bar on and audible alarm sounding to identify root cause. Replace the main control PCB and recalibrate O2 and pressure sensors. Abnormal hardware, software or watchdog reset. Spurious – software restarts possibly during treatment. Software restarts Replace the ‘Error number’ main control alarm prompt.
Service Manual 675-120 Revision D May 2005
Service Manual Chapter 7- Maintenance Cleaning CAUTION Do not immerse any part of the IFSD in water or sterilize it with gas or steam. 1 Clean the exterior surfaces of the IFSD and the transducer interface with a mild soap or liquid disinfectant solution. Do not use cleaning agents that contain abrasives. 2 Make sure that cleaning agents do not enter the unit through patient connection ports. Maintenance WARNING Oxygen vigorously accelerates combustion.
Service Manual 4 Numbers in parenthesis in the Removal/Fitting procedures are the item numbers on the associated figure. 5 Lubricate new O-rings before installation with grease, Krytox 240AC before installation. Maintenance Frequencies Table 7 shows the recommended frequencies for replacement of components.
Infant Flow® SiPAP Removal and Fitting of Case Refer to Figure 12. Removal 1 Remove the ten screws (1) on the rear panel. 2 Pull off the case (2). Fitting 1 Install the case (2) over the main frame, making sure that all wires and pipes 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 - Oxygen Leak Test) and functional check of the IFSD.
Service Manual 2 Disconnect the battery lead connector SK3 (1) (cable 5) from the plug PL3 on the Main Processor PCB. Remove the screw (2) on the rear panel and remove the spacer (3). Note position of cable tie securing battery, then cut and remove cable tie. 3 Pull the battery (4) complete with lead from the compartment. Note The battery is held in position in the compartment by a tab on the frame and secured by cable tie P/N 461964.
Infant Flow® SiPAP Removal and Fitting of Oxygen Filter Note This procedure can be done without removing the case. Refer to Figure 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 (4) on the banjo screw (1). 2 Install a new filter (3) in the air/oxygen mounting block and install the banjo screw (1). 3 Tighten the banjo screw (1).
Service Manual Removal and Fitting of Fuel Cell Filter/Restrictor Refer to Figure 15. Removal 1 Remove the case . 2 Remove the oxygen filter screw (1) from the flow mixer 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 1 Install a new O-ring (5) on the oxygen filter screw (1). Install a new O-ring (4) and the filter/ restrictor (3) into the flow mixer block (2).
Infant Flow® SiPAP Removal and Fitting of the Fuel Cell Refer to Figure 16. Removal 1 Remove the case. 2 Disconnect the connector SK12 (1) from the top of the fuel cell. 3 If necessary, remove the screw (2) securing the C clip (3) and release the C clip securing the cable (cable 7) and the ferrite. 4 Unscrew the fuel cell (4) from the flow mixer block (5).
Service Manual Figure 16 - Fuel Cell Removal/Fitting Removal and Fitting of Blender and Components Refer to Figure 17. Removal 1 Remove the case. 2 Remove the battery. 3 Disconnect the connector SK1 (1) on the LED PCB. 4 Disconnect the connector SK5 (2) on the Main Processor PCB. 5 Disconnect the connector at PL5 (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.
Infant Flow® SiPAP 13 Remove 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 and the PA flow tube and remove the Valve/Sensor PCB.
Service Manual Figure 17 - Blender and Components Removal/Fitting Fitting 1 Fit new pilot drive check valves as follows: a Fit the seat (28), a duckbill check valve (26), the guide (27), the second duck bill check valve into the cylinder (23). b Hold the nut (25) and tighten the cylinder body (23). c Hold check valve assembly against cable tie mounts behind flow meter and install new cable tie. Repeat for the other check valve assembly.
Infant Flow® SiPAP b Fit the Valve/Sensor PCB (13) to the D plug PL2. c Fit the five screws (16). d Connect the fuel cell connector SK1 (14) at PL1 on the Valve/Sensor PCB. e Connect the dump/vent valve connector SK3 (15) at PL3 on the Valve/Sensor PCB. 5 Fit a new O-ring (12) to the front panel assembly. 6 Fit the front panel assembly (11) and install the eight screws (10). 7 Set the FiO2 collet on the blender to the 21 % position.
Service Manual Removal and Fitting of Case Bleed Filtered Restrictor Refer to Figure 18. Removal 1 Remove the case and loosen the clamp securing the restrictor 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 (3) to the tube in the proper orientation. 2 Re-secure the restrictor to the sheet metal.
Infant Flow® SiPAP Removal and Fitting of PA Solenoid Valve The PA Solenoid Valve is replaced by replacing the Valve/Sensor PCB Removal 1 Remove the case. 2 Remove the Valve/Sensor PCB. Fitting 1 Install the new Valve/Sensor PCB. 2 Carry out an Oxygen Leak check (see Appendix A - Oxygen Leak Test) and functional check of the IFSD and calibrate the fuel cell. Firmware Reload/Upgrade The firmware reload/upgrade uses a Software Download Utility (P/N 675-821) and a download cable (P/N 675-819).
Service Manual 10 Click on the Download button. The download takes approximately 1 minute at 57600 bps. When the download is complete, the audible alarm on the IFSD stops and the unit enters the normal operational mode. 11 Disconnect the Download Cable from plug PL4 on the Main Processor PCB. 12 Refit the case. 13 Carry out a functional check of the IFSD.
Infant Flow® SiPAP Chapter 8 – Explanation of Symbols The following symbols may be referenced on the Infant Flow® SiPAP driver or in accompanying documentation Symbol Source / Compliance Meaning Symbol #03-02 IEC 60878 Indicates ATTENTION, consult ACCOMPANYING DOCUMENTS Symbol #5016 IEC 60417 This symbol indicates a FUSE. VIASYS Healthcare Symbol This symbol indicates an INTERNAL BATTERY FUSE 2.
Service Manual Symbol Source / Compliance Meaning Operating temperature range of unit Warning Bell VIASYS Healthcare Symbol VIASYS Healthcare Symbol Symbol # 5333 IEC 60417 Symbol #02-03 IEC 60878 Respiratory Connection and Indicator 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.
Infant Flow® SiPAP Symbols used on buttons The following symbols are used to label user input areas within the graphical display. As needed displays in this table are shown separately as Domestic US configuration displays (left-hand column) and International configuration displays (right-hand column). 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.
Service Manual Nasal CPAP mode with breath rate monitoring BiPhasic mode BiPhasic mode with breath rate monitoring BiPhasic Tr mode with breath rate monitoring Manual Breath. Single breath cycle at current settings for Ti, NCPAP Pres high and O2 %. One breath 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.
Infant Flow® SiPAP Appendix A - Oxygen Leak Test Oxygen Leak Test This test will check for leaks within the enclosure. Test equipment needed: Calibrated oxygen analyzer 1. Connect the driver to the air and oxygen supplies. Use adaptors to couple to the customer-specified gas block on the driver. 2. Connect the oxygen analyzer sampling tube to the driver by replacing the M6 Pan Screw (Item 31, 675-002) with an M6 fitting.
Service Manual 6. Set the pressure High Flow Meter to about 2 LPM then push its softkey button under the right flowmeter icon. 7. 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 2). Figure 2 9. The next screen varies but select BiPhasic soft key (Figure 3).
Infant Flow® SiPAP 10. Accept the default BiPhasic settings by selecting the BiPhasic soft key again (Figure 4). Figure 4 11. Verify that the measured value 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 5).
Service Manual Appendix B- Product Configurations Non-US Configuration Parameters Parameter Set Oxygen concentration, %O2 Min 21 Max 100 Accuracy ±3 Units % CPAP flow rate 0 15 ±15% L/min Bi-level additional flow rate 0 5 ± 15% L/min BiPhasic on time, Ti (inspiration time) 0.1 3.0 * ± 0.005 seconds BiPhasic rate, R (respiration rate) 1 120 ± 0.5 pm BiPhasic Tr backup rate, Rb (backup respiration rate) Breath rate timeout 1 120 ± 0.
Infant Flow® SiPAP Appendix C - Spare Parts To identify a part referenced in this manual, refer to the associated Figure and Item number in Table 8.
Service Manual Additional Service Parts Part Number Description 467472 BLENDER CONTROL KNOB 467468 CAP, BLENDER CONTROL KNOB 467471 POINTER, BLENDER CONTROL KNOB 467469 FLOWMETER KNOB 467470 CAP, FLOWMETER KNOB 675-308 CASE 467467 FOOT, POLYURETHANE .
Infant Flow® SiPAP Part Number Description 677-002 TRANSDUCER INTERFACE 467349 ABDOMINAL RESP SENSOR 25PK 03895 VALVE CHECK DCKBL BLACK 06804 FILTER NYLON CONE INL 467269 FILTER ELEMENT (WATERTRAP) 777235 POWER SUPPLY MK3 467455 SWITCH COVER 675-256 SWITCH CABLE ASSY S117641 ASSY PCB LED AMBIENT SENSOR 675-310 FRONT PANEL 675-312 CONNECTOR PATIENT INLET 675-316 MK3 TRIGGER LEUR 675-209 O2 SENSOR CABLE 777072-xxx BLOCK, INLET O2/AIR System 777242-101 SERVICE KIT, Mk3 DRIVE
Service Manual 675-120 Revision D May 2005
Infant Flow® SiPAP Glossary Term Meaning Apnea Temporary inability to breathe; monitoring of breathing (non-US labeling) Bpm Breaths per minute (applies to each of spontaneous, triggered and mandatory) Bps Bytes per second cmH2O Centimeters of Water (Pressure) CPAP Continuous Positive Airway Pressure FiO2 Fraction of Inspired Oxygen Generator Patient attachment for delivering CPAP, used with nasal prongs or mask I/E Inspiration/Expiration ratio IFSD Infant Flow SiPAP Driver LBR Low
Service Manual Term Meaning Sigh A single pulse of additional gas flow Tapnea / TLBR 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 Ti 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 675-120 Revision D
