CareFusion Infant Flow SiPAP Operator'S Manual Download Page 73

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Appendix D Fault Management

675–101–101 Rev. P

E## Fault condition

Consequence

Clas-

sification

Software

Response

Corrective

Action Required

E10 Non-volatile

memory fault

Unable to

retrieve/set unit

configuration and

calibration data

Unusable

User lockout:

Error "E##"

prompt

Service: Fix or

replace PCB

E11 Calibration data

lost

Sensor readings

invalid

Unusable

User lockout:

Error "E##"

prompt

Service: Low

level calibration

, Pressure

and Flow)

E12

Configuration DIP

settings and/or

PT PRESENT

different to non-

volatile

configuration

record

Possible

incomplete unit

set-up performed

Unusable

User lockout:

Error "E##"

prompt

Service: Perform

set-up procedure

E20

Charged battery

voltage too low

(<11V) when

under test load

Battery capacity

low

No backup

Battery fault icon

flashes and "E##"

alarm

Service: Fix

Battery or

charger

E21

External supply

voltage too low

(<14V) to charge

battery (battery

flat)

Battery will not

charge

No backup

Battery low alarm

continues even

through external

power applied -

"E##" alarm

User: Plug in

correct external

supply

Service: Fix PSU

circuits

E22 Analogue supply

rails out of limits

Unreliable sensor

readings

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

circuits

E23

Valve driver

supply rails out of

limits

Valve operations

unreliable

Unusable

User lockout:

Error "E##"

prompt

Service: Fix valve

supply rail

E24

Hardware 'safe-

start' watchdog

disabled

Valves disabled

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

reset/safe-start

circuits

E30

Pressure sensor

fault (ADC hits

rail)

Pressure sensor

readings invalid

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

sensor/circuits

E31

Zero valve not

connected (via

sense)

Pressure sensor

readings

unreliable

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

valve/circuits

E32

Zero valve

activation fault

(via sense)

Pressure sensor

readings

unreliable

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

valve/circuits

E33

Unable to auto-

zero pressure

sensor

Pressure sensor

readings

unreliable

Unusable

User lockout:

Error "E##"

prompt

Service: Fix

valve/sensor/circ

uits

E41

Dump valve not

connected (via

sense)

No over pressure

protection

Restricted Restricted mode:

Error "E##" alarm

Service: Fix

valve/circuits

E42

Dump valve

activation fault

(via sense)

No over pressure

protection

Restricted Restricted mode:

Error "E##" alarm

Service: Fix

valve/circuits

Summary of Contents for Infant Flow SiPAP

Page 1: ...Infant Flow SiPAP Operator s Manual ...

Page 2: ...s only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement 2009 2013 CareFusion Corporation or one of its subsidiaries All rights reserved CareFusion the CareFusion logo and Infant Flow are trademarks of CareFusion Corporation or one of its subsidiaries All other trademarks are the property of their respective owners CareFusion 22745 Savi Ra...

Page 3: ...g back pressure Added a Note regarding the Hudson RCI Humidification System Added the sentence Ensure there is a minimum 8 LPM set on the NCPAP PRES Low Flow meter to the first paragraph under Two Point O2 Sensor Calibration Changed step 8 regarding the nCPAP pressure Changed the second and third paragraphs under Changing a Control Added Setting a Manual Breath Added a note regarding the enabling ...

Page 4: ...ent concerning a depleted or damaged internal oxygen cell Added a warning about using an external oxygen monitor Added content to explain fault code E5X Replaced key with button clarified oxygen alarm by adding the audible added clarification of the internal monitoring being disabled and that an external oxygen monitor must be used Added a Note regarding the 2 nd Flow Meter being used for manual b...

Page 5: ...e name Infant Flow Updated the address information to include symbols In the Flow Pressure Relationship section added the Flow pressure nomogram for the Infant Flow LP generator In the Leak Test procedure step 4 added for the Infant Flow LP generator adjust the flow meter to 9 L M In the Alarms Test section in the Alarm Test Initial Settings table added Infant Flow LP 9L min for delivery of 5 cmH2...

Page 6: ...sed 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 products f...

Page 7: ...Chapter 3 Summary of Warnings and Cautions 7 Chapter 4 Unpacking and Setup 11 Chapter 5 Operation 23 Chapter 6 Operating Modes 35 Chapter 7 Alarms and Indicators 37 Chapter 8 Maintenance and Cleaning 43 Chapter 9 Explanation of Symbols 45 Appendix A Product Configurations 49 Appendix B Pneumatic Diagram 51 Appendix C Alarm Troubleshooting 53 Appendix D Fault Management 57 Glossary 63 Index 65 ...

Page 8: ...re 5 Flow pressure nomogram for 675 CFG XXX when used with the Infant Flow variable flow generator 15 Figure 6 Flow pressure nomogram for 675 CFG XXX when used with the Infant Flow LP or AirLife variable flow generator 16 Figure 7 Front Panel 23 Figure 8 Rear Panel 24 Figure 9 Setup Screen 28 Figure 10 Alarm set confirm Screen 29 Figure 11 Mode Select Screen 29 Figure 15 NCPAP 35 Figure 16 BiPhasi...

Page 9: ...nual 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 EN ISO 21647 Electri...

Page 10: ...x Infant Flow SiPAP 675 101 101 Rev P Electromagnetic Environment Specifications ...

Page 11: ...Infant Flow SiPAP xi 675 101 101 Rev P ...

Page 12: ...port environments and is indicated for the treatment of newborn and infant patients The Infant Flow SiPAP driver should only be operated by properly trained clinical personnel under the direction of a physician Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician Reuse of single patient use accessories may degrade the performance of the product or ca...

Page 13: ...the following Technical Standards to which Conformity is declared EN60601 1 and EN60601 1 2 EN 10993 EN 14971 EU Notified Body BSI Reg No 0086 Trade names Infant Flow SiPAP Manufactured by CareFusion 22745 Savi Ranch Parkway Yorba Linda CA 92887 4668 If you have a question regarding the Declaration of Conformity for this product please contact CareFusion ...

Page 14: ...xiv Infant Flow SiPAP 675 101 101 Rev P Infant Flow SiPAP ...

Page 15: ...nd tested to perform optimally when used only with accessories available from CareFusion These accessories include the variable flow generator single limb breathing circuit nasal prongs nasal masks and fixation device either bonnet or headgear Infant Flow SiPAP Features The expanded capabilities of the Infant Flow SiPAP Plus and Comprehensive configurations allow for applications to broader range ...

Page 16: ... 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 1 Decreased imposed work with a new nasal continuous positive airway pressure device Klausner James F PhD Lee Amy Hutchison Alastair A FRACP Pediatric Pulmonology 22 188 194 1996 2 A Prospective Randomized Controlled Trial...

Page 17: ...hensive models only Controls Time High T High 0 1 3 0 seconds Rate R 1 120 Non U S Configuration Parameters 1 54 U S Configuration Parameters Apnea Interval Tapnea 10 30 seconds 5 second intervals Non U S Configuration Parameters TLBR 10 30 seconds 5 second intervals U S Configuration Parameters NCPAP Pres Low flow meter 0 15 L min accuracy 15 of selected output Pres High flow meter 0 5 L min accu...

Page 18: ...attery Input gases failure 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 4 8 to 6 bar 40 6 to 87 PSI Maximum differential pressure 2 bar 30 psi Manometer Range 0 to 20 cmH2O accuracy 2 of span Gas Connections ...

Page 19: ...D1420 100 Silencer Bacterial Filter and adaptor is less than 0 56 cmH2O at 15 LPM and less than 0 40 cmH2O at 5 LPM SiPAP Gas Monitor Total system response time 8 61 seconds Drift No drift after six hours of operation Cyclical pressure Up to 10 Kpa 100 cmH2O has no effect on the gas monitor accuracy Accuracy of the oxygen reading at 30 40 and 60 No drift when cycling the ventilator With non divert...

Page 20: ...6 Chapter 2 Product Specifications 675 101 101 Rev P Infant Flow SiPAP ...

Page 21: ... or practices that could result in damage to the driver or other equipment NOTES identify supplemental information to help you better understand how the driver works Warnings Infant Flow SiPAP driver is intended for use by a trained practitioner under the direct supervision of a qualified physician When the Infant Flow SiPAP driver is connected to a patient a trained health care professional shoul...

Page 22: ...tions may require immediate attention Nasal CPAP therapy in general can cause nasal irritation septal distortion skin irritation and pressure necrosis Adherence to the recommended usage instructions for the Infant Flow nCPAP System and AirLife Infant nCPAP System may reduce the incidence of these complications It is strongly recommended that regular monitoring for gastric distention be carried out...

Page 23: ...zed CareFusion service technician or factory trained technician see Service Manual P N 675 120 A protective ground connection by way of the grounding conductor in the power cord is essential for safe operation Upon loss of protective earth ground all conductive parts including knobs and controls that may appear to be insulated can render an electrical shock To avoid electrical shock plug the power...

Page 24: ...essories approved for use by CareFusion should be used If in doubt please contact your local sales representative Employ safe lifting procedures when assembling the unit Do not sterilize the driver The internal components are not compatible with sterilization techniques Do not submerge the SiPAP driver spray the driver with liquid or pour cleaning liquids over or into the driver Following each ala...

Page 25: ...Infant Flow SiPAP 11 675 101 101 Rev P Chapter 4 Unpacking and Setup Assembly and physical setup Figure 1 Stand unpacking and assembly Optional Accessory ...

Page 26: ...12 Chapter 4 Unpacking and Setup 675 101 101 Rev P Figure 2 Stand and Driver assembly Infant Flow SiPAP Driver Optional Accessory ...

Page 27: ...Chapter 4 Unpacking and Setup 13 675 101 101 Rev P Attaching a patient circuit Figure 3 Driver assembled with patient circuit and humidifier Infant Flow SiPAP Driver Optional Accessory ...

Page 28: ...low SiPAP driver it is recommended that the standard compliance column be used Attaching the Abdominal Respiratory Sensor Figure 4 Attaching the Abdominal Respiratory Sensor 1 Connect the Transducer Assembly to the front panel of the driver Figure 3 2 Connect Abdominal Respiratory Sensor to the Transducer interface 3 Apply gentle compression to sensor Verify function with illumination of LED on tr...

Page 29: ...nd flow settings is shown in Figure 5 For example 8 L min gas flow provides approximately 5 cmH2O Note Individual devices have a tolerance of up to 10 from that illustrated in the nomogram and in particular at pressures below 2 cmH2O Figure 5 Flow pressure nomogram for 675 CFG XXX when used with the Infant Flow variable flow generator Flow Pressure Nomogram for reference only to show typical flow ...

Page 30: ... Flow LP or AirLife variable flow generator 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 31: ...puts Audible and visual alarms indicators 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 During the ...

Page 32: ...or The internal oxygen monitor may be disabled using the Disable 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 SiPAP unit is connected to a patient and the internal oxygen m...

Page 33: ...ender setting and the measured oxygen value are within 3 Touch the associated flashing screen icon to confirm 6 Adjust the Pres High flow meter as prescribed for the current patient Touch the associated flashing screen icon to confirm 7 Connect the Transducer Interface to the front panel of the driver if breath monitoring is desired in treatment Touch the associated flashing screen icon to confirm...

Page 34: ...ification test ensure that control settings and alarm limits are reset as instructed before proceeding to the next test Alarm Test Initial Settings Air Supply Pressure 30 psig 2 1 bar O2 Supply Pressure 30 psig 2 1 bar Patient Circuit Infant Flow or AirLife Infant nCPAP System Patient Circuit Generator Infant Flow or AirLife Infant nCPAP System Generator NCPAP Pres Low flow meter Infant Flow 8 L m...

Page 35: ...set button for 3 seconds 6 Low O2 Alarm Adjust the O2 control to 25 Verify that the Low O2 alarm activates Return the O2 control setting to 30 Reset alarms by pressing the Alarm Mute Reset button for 3 seconds 7 Loss AC Alarm Disconnect the AC power cord from the wall outlet Verify that the Loss AC alarm activates Reconnect the AC power cord Clear the alarm by pressing the Alarm Mute Reset button ...

Page 36: ...d Tests 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 37: ...AP Pres Low and Pres High and a O2 blender control Patient circuit connections are located along the bottom panel LEDs along the top of the front panel indicate power on connection to wall AC active alarms and Transducer Interface connection to the driver An ambient light sensor is located under the front panel to adjust the backlight of the screen display in high and low light environments Figure...

Page 38: ...24 Chapter 5 Operation 675 101 101 Rev P Rear Panel Figure 8 Rear Panel ...

Page 39: ...a pressed appearance When there is an active alarm associated with a measured value the measured value concerned is displayed with RED FLASHING text The associated limit value if any is displayed in RED When an alarm that is associated with a measured value is resolved the device remains in a LOW priority alarm state with the measured value displayed in YELLOW FLASHING text and the associated limi...

Page 40: ...result by using your fingernail a pen or similar item to make changes Increase Decrease Buttons Pressing the increase or decrease buttons causes a currently selected control to be changed to the next valid greater or lesser value Each press of the increase or decrease button is accompanied by an audible click If the control limit is reached an audible beep sounds to alert the operator Displays of ...

Page 41: ...ion is available in CPAP Biphasic and Biphasic tr modes For manual breath to be active when the manual button is selected the pre use pressure high check has been completed and the pressure high flow meter is set for preferred manual breath One manual breath is delivered per button press Note The Pressure High Flow Meter must have flow above zero in order to deliver manual breaths Table 2 Paramete...

Page 42: ...ociated flashing button to confirm The icon changes to a check mark and the next button flashes Adjust the Pres High flow meter as desired for delivery of BiPhasic BiPhasic tr or manual breaths using counterclockwise turns to increase and clockwise turns to decrease the flow Touch the associated flashing button to confirm The icon changes to a check mark and the next button flashes If breath rate ...

Page 43: ...omatically When the alarm limits have been set the screen display changes to the Mode Select Screen with the driver operating in NCPAP mode Note Press High Flow meter must be checked through the Start up screen and be set during operation This enables manual breath or back up apnea breath where applicable to be active CAUTION Do not adjust any of the Alarm Limit settings to an extreme value Select...

Page 44: ...ttons to adjust the setting as desired Confirm the change by pressing the control again 4 Parameter Adjust Screen During normal operation active controls for the current operating mode can be adjusted by touching the control using the increase or decrease arrows to make the adjustments and then pressing the control again to confirm the change Figure 12 Parameter Adjust Screens 5 Main screen The Ma...

Page 45: ...essing the change screen button The monitored parameters screen displays measured values and control settings Adjustments to controls active for the currently selected mode are possible from this screen To return to the main screen press the screens button again Figure 14 Monitored Parameters Screen ...

Page 46: ...mference measurement to determine bonnet size 3 Loosely weave Generator straps through the buttonholes Begin from the inside of the colour coded buttonhole Place the Generator on top of the bonnet above the central Velcro strip 4 Place the bonnet onto the infant s head checking that the ears are in a normal position Ensure the bonnet is pulled well down over the ears and down to the nape of the ne...

Page 47: ...r 2 Turn off SIPAP driver If therapy has been discontinued after turning off power 1 Turn the flow rate of the low pressure flow meter and the high pressure flow to zero 2 Disconnect air and oxygen high pressure hoses from wall outlet 3 Remove nCPAP circuit and generator and dispose of per hospital procedure Directions for using the AirLife Infant nCPAP System Please refer to P N 36 5569 included ...

Page 48: ...34 Chapter 5 Operation 675 101 101 Rev P Infant Flow SiPAP ...

Page 49: ...onitoring displayed NCPAP Mode Breath rate monitoring requires the use of the Transducer Assembly part number 677 002 and the Abdominal Respiratory Sensor part number 467349 Figure 15 NCPAP BiPhasic The BiPhasic mode allows for time triggered pressure assists with or without breath rate monitoring and adjustable low breath rate alarm delivered based on clinician set Time High T High criteria rate ...

Page 50: ...d pressure assists with breath rate monitoring enabled adjustable apnea time interval apnea alarm and adjustable apnea back up rate The upper level pressure is delivered based on operator set Time High T High and pressure settings Figure 17 BiPhasic tr This mode available in Comprehensive configurations only ...

Page 51: ... alarm Measured parameters and alarm limits associated with a high or medium priority alarm condition flash RED HIGH priority or YELLOW MEDIUM priority to denote alarm condition and priority Silencing audible alarms Pressing the Alarm Mute Reset button will silence active alarms for up to 30 seconds If a new high priority alarm condition occurs during the alarm silence time period the silence will...

Page 52: ...nd time triggered BiPhasic modes and 15 cmH2O in BiPhasic tr mode Upon activation of this alarm the patient circuit pressure drops to near zero Pressure is restored after 3 seconds and reduces to near zero again should the condition causing the alarm remain Low Airway Pressure A HIGH priority audible and visual low pressure alarm activates if pressures fall to 2 cmH2O below the measured airway pre...

Page 53: ...cal Power No AC or DC power The Infant Flow SiPAP will continue to deliver NCPAP flow only as set from the NCPAP Pres Low flow meter and the set O2 in the event of a total loss of AC and DC power In this mode visual indications and audible alarm warnings are not given except for the supply gases failure alarm Error code indication When a unit error is active and this does not cause complete device...

Page 54: ...status charge level Green indicates full charge red indicates charge 40 External power source not connected Flat battery Battery fault battery unable to hold charge or supply fault Respiratory transducer interface has become detached during breath monitoring Indication during pre use checks that the NCPAP Pres Low flow meter should be set as desired and pressure verified Indication during pre use ...

Page 55: ...Does not verify attachment of sensor to patient Refer to manual Power has failed re connect external power source Display of O2 measured value and associated alarms Display of NCPAP airway pressure measured value and alarms NCPAP modes only Display of mean airway pressure measured value and alarms BiPhasic and BiPhasic tr modes only I E ratio Spontaneous breathing rate Set parameter T High Set par...

Page 56: ...indicated in yellow below delivered airway pressure graph Device fault fault code will be indicated Refer to manual Contact qualified service technician Note Provision of labeling in this manual for any function should not be taken as evidence that the function is available For example parameter RB relates to BiPhasic tr mode not currently approved for use in the US ...

Page 57: ...tenance is required by the operator other than that listed below There are no operator serviceable parts The unit must only be maintained and serviced by an approved service supplier or trained biomedical engineer Only parts approved by CareFusion may be used in this unit Refer to the Service Manual or your Service Supplier for an approved service parts list WARNING Oxygen vigorously accelerates c...

Page 58: ...ections and ports are suitably covered to prevent the ingress of dirt moisture and foreign objects If the unit is not being used for a long period of time remove the battery refer to the Service Manual or your Service Technician Dispose of scrap units in accordance with the local regulations Refer to the Service Manual or your Service Supplier ...

Page 59: ...dicates 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 necessarily being the earth ground potential e g for local bonding Symbol 5032 IEC 60417 Symbol 01 14 IEC 30878 This symbol is located on the rating plate It indicates the equipment is...

Page 60: ...01 41 ISO 7000 2004 2301 Alarm IEC 60878 1988 02 03 Type BF patient applied part Intertek Group ETL Mark and Registration Number ISO 15223 2000 3 13 EN 980 2003 4 4 Year of Manufacture IEC 60878 03 02 Read Accompanying Documents ISO 15223 2000 3 1 4 EN 980 2003 4 4 Unique Batch Number Identifier ISO 15223 2000 3 12 EN 980 2003 4 3 Use Before Expiry Date shown Year Month ISO 15223 2000 3 2 EN 980 2...

Page 61: ...nd non US configuration displays right hand column Table 1 Button Symbols Symbol Description High Priority Alarm Active red flashing Medium Priority Alarm Active yellow flashing Low Priority Alarm Active yellow does not flash No alarms are present green does not flash Active alarm silenced Adjust BiPhasic rate Adjust BiPhasic tr backup rate Adjust apnea alarm timeout Adjust low breath rate alarm t...

Page 62: ...e BiPhasic cycle is delivered regardless of button press duration Toggle between Main Screen and Monitored Parameter Screen Go to user calibration screen Confirm Wait Completed Action has failed Press to un lock keypad Warning message To clear press any of the three icons Oxygen monitor and alarms disable Note Provision of labeling in this manual for any function should not be taken as evidence th...

Page 63: ...20 sec Note BiPhasic tr mode not currently available in the United States In non US configurations T High automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 100 milliseconds US Configuration Parameters Table 3 US Configuration Parameters Parameter Min Max Accuracy Units Default Set Oxygen concentration O2 21 100 3 N A NCPAP Pres Low flow rate 0 15 15 L min N A...

Page 64: ...50 Appendix A Product Configurations 675 101 101 Rev P Infant Flow SiPAP ...

Page 65: ...Infant Flow SiPAP 51 675 101 101 Rev P Appendix B Pneumatic Diagram ...

Page 66: ...52 Appendix B Pneumatic Diagram 675 101 101 Rev P Infant Flow SiPAP ...

Page 67: ...5 below setting for 15 seconds High Blender setting changed Supply gas failure Water trap overflow Press Alarm Mute to silence the alarm Correct delivered oxygen concentration Press Alarm Reset for 3 seconds to set new limits Over pressure 11 cmH2O in NCPAP and BiPhasic modes High Flow rate set too high Occlusion of exhalation limb Blocked silencer bacteria filter Check exhaust tube filter Reduce ...

Page 68: ...ds to silence and reset alarm limits Reset alarm limits after setting change and patient circuit disconnect reconnect Low NCPAP Pres Low CPAP 2 cmH2O below set for 15 seconds or 1 5 cmH2O at any time High NCPAP Pres Low setting change Circuit disconnect reconnect Circuit leak Push Alarm Mute button for 3 seconds to silence and reset alarm limits Reset alarm limits after setting change and patient ...

Page 69: ...or one gas fails completely Check gas inlet supplies Check inlet water trap Refer blender to service technician Oxygen cell calibration error High Oxygen cell incorrectly calibrated damaged or depleted Calibrate or replace oxygen cell Refer to Service Manual Electrical fault High AC power LED does not match screen icon Refer to Service Technician Water trap blocked High and Blender Alarm Full or l...

Page 70: ...56 Appendix C Alarm Troubleshooting 675 101 101 Rev P Infant Flow SiPAP ...

Page 71: ...lt Classification Severity Classification Impact On Unit Functionality Reporting Mechanism Measurements Control Modes and Features O2 CmH 2 O NCPAP apnea Biphasic tr biphasic 1 major Un usable Unit is inoperable under software control but can still be used in an un powered pneumatic mode A list of error codes are presented to the user via the Fault lockout display 2 Re stricted Unit functionality ...

Page 72: ...ault condition occurs either before treatment begins or while being applied the software will respond in the following way Table 6 Fault Recovery E Fault condition Consequence Clas sification Software Response Corrective Action Required Program memory checksum error Software corrupt execution inhibited Unusable Hardware held in permanent reset condition with alarm bar lit status LED on Service Rel...

Page 73: ...uits E22 Analogue supply rails out of limits Unreliable sensor readings Unusable User lockout Error E prompt Service Fix circuits E23 Valve driver supply rails out of limits Valve operations unreliable Unusable User lockout Error E prompt Service Fix valve supply rail E24 Hardware safe start watchdog disabled Valves disabled Unusable User lockout Error E prompt Service Fix reset safe start circuit...

Page 74: ...nreliable No oxygen monitor High priority alarm Error E prompt User recalibrate the oxygen cell E55 Oxygen sensor disabled by the operator Oxygen sensor readings unreliable No oxygen monitor Error E prompt User re power the device to re enable oxygen monitoring E61 BiPhasic valve not connected via sense BiPhasic modes unusable Restricted Restricted mode Error E alarm Service Fix valve circuits E62...

Page 75: ...t Spurious Software restarts E alarm Software Fix persistent exceptions Service Fix abnormal reset E91 Internal software error detected Software unreliable Unusable User lockout Error E prompt Software Fix software error E99 Unknown error detected Software unreliable Unusable User lockout Error E prompt Software Fix software error 1 Error codes in parentheses brackets are generated as an indirect ...

Page 76: ...62 Appendix D Fault Management 675 101 101 Rev P Infant Flow SiPAP ...

Page 77: ...BR NCPAP with Low Breath Rate monitoring US labeling NCPAP Apnea NCPAP with Low Breath Rate monitoring non US labeling Rate Mandatory rate per minute active in BiPhasic mode RB Backup ventilator rate in BiPhasic mode during apnea alarm per minute non US labeling RSP Patient s spontaneous respiratory rate per minute s sec Seconds Tapnea TLBR Apnea Interval non US labeling or Low Breath Rate LBR mon...

Page 78: ...64 675 101 101 Rev P Infant Flow SiPAP ...

Page 79: ...s ix EMC ix environmental requirements 5 Error code indication alarm 39 F fault lockout screen 61 faults 57 features 1 fixation 32 Flat Battery alarm 39 front panel 23 Fully integrated alarm package 1 G gas flow 15 H High Airway Pressure alarm 38 High and Low O2 alarm 38 High Patient Circuit Pressure alarm 38 I incompatible control settings 26 increase buttons 26 Indicators and Controls 23 intende...

Page 80: ...eck 17 R radio frequency energy ix Rear Panel 24 reset alarm limits 37 S safety information 7 Screen Displays 28 Screen Lock 2 Set Up screen 28 silence active alarms 37 Silencer Bacterial Filter 5 Soft key operation 25 specifications 3 Storage 44 Supply Gases Failure alarm 38 symbols 45 T Troubleshooting 53 U User Interface 28 User Verification Test 17 User Verification Test Checklist 22 W warning...

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