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Infant Flow SiPAP Operator Manual

1. vii List of Figures viii List of Tables viii Notices ix Chapter 1 Product Description 1 Chapter 2 Product Specifications 3 Chapter 3 Summary of Warnings and Cautions 7 Chapter 4 Unpacking amp Setup 11 Chapter 5 Operation 23 Chapter 6 Operating Modes 33 Chapter 7 Alarms and Indicators 35 Chapter 8 Maintenance amp Cleaning 41 Chapter 9 Explanation of Symbols
2. 24 Figure 8 Set Up Screen 27 Figure 9 Alarm set confirm Screen 28 Figure 10 Mode Select Screen 29 Figure 11 Parameter Adjust Screens 29 Figure 12 Main Screen 30 Figure 13 Monitored Parameters Screen 30 Figure 14 NCPAP 33 Figure 15 BiPhasic 33 Figure 16 BiPhasic tr 34 Figure 17 Flat Battery screen 37 List of Tables Table 1 Functions and Accessories 2 Table 2 Soft key operation 25 Table 3 Parameter Default Value
3. 27 Table 4 Alarm Symbols and Indicators 38 Table 5 Equipment Symbols 43 Table 6 Button Symbols 45 Table 7 Non US Configuration Parameters 49 Table 8 US Configuration Parameters 49 Table 9 Alarm Troubleshooting 53 Table 10 Fault Classification 57 Table 11 Fault Recovery 58 Infant Flow SiPAP ix 675 101 101 Rev M Notices E MC Notice This equipment radiates and is susceptible to radio frequency energy If not installed and used in accordance with the instructions in this manual electromagnetic interference may result The equipment has been tested and found to comply with the limits set forth in BS EN60601 1 2 for Medical Electrical Equipment Part 1 2 General requirements for safety collateral standard Electromagnetic compatibility requirements and tests These limits provide reasonable protection against electromagnetic interferen
4. 43 Appendix A Product Configurations 49 Appendix B Pneumatic Diagram 51 Appendix C Alarm Troubleshooting 53 Appendix D Fault Management 57 Glossary 63 Index 65 viii Infant Flow SiPAP 675 101 101 Rev M List of Figures Figure 1 Stand unpacking and assembly 11 Figure 2 Stand and Driver assembly 12 Figure 3 Driver assembled with patient circuit and humidifier 13 Figure 4 Attaching the Abdominal Respiratory Sensor 14 Figure 5 Flow Pressure Nomogram 15 Figure 6 Front Panel 23 Figure 7 Rear Panel
5. 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___________________________________________________________ 22 Chapter 4 Unpacking amp Setup 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 23 675 101 101 Rev M Chapter 5 Operation Front Panel Indicators and Controls The front panel consists of a LCD touch screen display with key pad separate flow meter controls for adjustment of NCPAP 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 6 Front Panel 24 Chapter 5 Operation 675 101 101 Rev M Rear Panel Figure 7 Rear Panel Chapter 5 Operation 25 675 101 101 Rev M Table 2 Soft key operation Description Example A button which is enabled A button which is inhibited due to non availability of the designated feature or pending acknowledgement of an active alarm condition A selected mode or control pe
6. Refer to Service Technician Software fault High Cannot be reset See description of error code displayed Refer to Service Technician Software not running with unit connected to power High Cannot be reset See description of error code displayed Refer to Service Technician BiPhasic tr mode not currently available in the United States 56 Appendix C Alarm Troubleshooting 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 57 675 101 101 Rev M Appendix D Fault Management The general philosophy when handling a software detectable fault condition is to still allow a basic level of treatment to be applied to the patient with over pressure protection oxygen alarms and apnea monitoring where possible but inhibiting the higher level features of the unit such as BiPhasic modes Fault classification Each fault condition is classified according to the severity ratings where means not available under software control means available under software control and means may or may not be available depending on other severity rating 3 and 4 conditions which may occur individually or simultaneously Table 10 Fault Classification Severity Classification Impact On Unit Functionality Reporting Mechanism Measurements Control Modes and Features O2 CmH2O NCPAP apnea Biphasic tr biphasic 1 major Un usable
7. 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 is restricted to NCPAP modes only Where applicable error codes listed on mode selection screen Status bar mode alternates with worst error code 3 Un trigger able Patient trigger functions not available NCPAP and BiPhasic with breath monitoruing on and BiPhasic tr Where applicable error codes listed on mode selection screen Status bar mode alternates with worst error code 4a minor No backup Unit will not operate on battery when the external power is removed Battery status appears as if flat battery 58 Appendix D Fault Management 675 101 101 Rev M Severity Classification Impact On Unit Functionality Reporting Mechanism Measurements Control Modes and Features O2 CmH2O NCPAP apnea Biphasic tr biphasic 4b minor Spurious Spurious software exception trapped Software restarts and status bar extended mode alternates with worst error code 5 minor Spurious Non fatal error trapped High priority alarm status bar extended mode a
8. 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 O2 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 lt 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 lt 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 disabl
9. 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 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 Comparing Synchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal Continuous Positive Airway Pressure as Modes of Extubation Khalaf Nabeel M Brodsky Nancy Hurley John Bhandari Vineet PEDIATRICS 108 1 13 17 2001 3 Efficacy of Nasal Intermittent Positive Pressure Ventilation in Treating Apnea of Prematurity Lin Chyi Her MD Wang Shan Tair PhD Lin Yuh Jyh MD Yeh Tsu Fuh MD Pediatric Pulmonolgy 26 5 349 53 1996 Infant Flow SiPAP 3 675 101 101 Rev M 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 Comprehensive models only Controls Time H
10. Do not attach Generator to the patient until User Verification and initial set up into NCPAP mode is complete CAUTION Although failure of any of the above tests will not prevent the ventilator from functioning it should be checked to make sure it is operating correctly before use on a patient Power on Check This test is run automatically on power up of the driver and automatically performs the following checks Flash ROM Hardware Inputs Outputs 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 After two seconds the screen changes to Power Up Check Screen During the Power Up check Screen image shown in negative Warning bar comes on for one second Transducer Assembly LED comes on for one second Audible alarm sounds for one second Dump valve is tested Pressure is set to zero Chapter 4 Unpacking amp Setup 17 675 101 101 Rev M After two seconds screen changes to Set Up Screen Alarm limits are disabled and a flashing question mark appears under the NCPAP Pres Low flow meter screen ind
11. Infant Flow SiPAP Operator s manual ii Infant Flow SiPAP 675 101 101 Rev M This document is protected by United States and International Copyright laws This document may not be copied reproduced translated stored in a retrieval system transmitted in any form or reduced to any electronic medium or machine readable form in whole or in part without the written permission of CareFusion Information in this document is subject to change without notice This document is for informational purposes only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement 2009 2011 CareFusion Corporation or one of its subsidiaries All rights reserved Infant Flow is a registered trademark and SiPAP is a trademark of CareFusion Corporation or one of its subsidiaries All other trademarks are the property of their respective owners USA CareFusion 22745 Savi Ranch Parkway Yorba Linda California 92887 4668 Authorized European Representative CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg Germany 800 231 2466 tel 1 714 283 2228 tel 1 714 283 8493 fax 49 931 4972 0 tel 49 931 4972 423 fax carefusion com Literature number 675 101 101 Revision M Infant Flow SiPAP iii 675 101 101 Rev M R evis ion His tory Date Revision Changes September 2003 675 101 3 Release August 2004 D Release manual in VIASYS Res
12. Setup 675 101 101 Rev M Perform the Alarms Test on the Infant Flow SiPAP using the following steps and the initial settings provided 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 patient Verify that the low airway pressure alarm activates Restore the patient interface occlusion and press the Alarm Mute Silence button for 3 seconds to reset the alarms 4 High airway pressure alarm Adjust the NCPAP Pres Low flow meter to 11 L min Verify that the high airway pressure alarm activates Return the NCPAP Pres Low flow meter to 8 L min and press the Alarm Mute Silence button for 3 seconds to reset the alarms 5 High O2 Alarm Adjust the O2 control to 35 Verify that the High O2 alarm activates Return the O2 control setting to 30 Reset alarms by pressing the Alarm Mute Reset 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 ou
13. with a green check mark before other screens can be entered 2 Alarm set confirm Screen Figure 9 Alarm set confirm Screen Touch the NCPAP button or the Alarm Mute Reset button for 3 seconds to set the alarms and to move to the next screen If either button is not touched within 2 minutes the alarm limits will be set automatically 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 Chapter 5 Operation 29 675 101 101 Rev M Figure 10 Mode Select Screen 3 Mode Select Screen Here the operator can select the desired mode of operation Once selected the operator has the ability to adjust the screen controls for the mode selected Only the relevant controls available for the selected mode are visible To make a change to a control touch the control Both the control and its associated numeric display highlight and the adjust buttons appear Press up or down buttons 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
14. Flow SiPAP 675 101 101 Rev M R egulatory 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 cause cross contamination Clas s ification Type of Equipment Medical Equipment Class 1 and internally powered IPX1 Protected and uses type BF applied parts Equipment is not suitable for use in presence of flammable anesthetics 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 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 Infant Flow SiPAP 1 675 101 101 Rev M Chapter 1 Product Description Infant Flow SiPAP provides a non invasive form of respiratory support designed for infants in hospital environments such as Neonatal and Pediatric Intensive Care Units It can also be used when transporting these patients within the hospital environment Infant Flow SiPAP is currently available in a Plus or Comprehensive configuration The Plus configuration provides NCPAP
15. Respiratory Sensor 1 Connect the Transducer Assembly to the front panel of the driver Fig 3 2 Connect Abdominal Respiratory Sensor to the Transducer interface 3 Apply gentle compression to sensor Verify function with illumination of LED on transducer interface 4 Apply sensor with suitable tape Fig 4 a Pressure line perpendicular to tape b Sensor between umbilicus and xiphisternum c Placement on the side of the abdomen may be necessary 5 Verify correct placement a Observe spontaneous breathing b Transducer LED illuminates on expiration Front panel Transducer LED illuminates on inspiration Chapter 4 Unpacking amp Setup 15 675 101 101 Rev M Flow Pressure Relationship The Infant Flow SiPAP is subject to a direct relationship between the controlled enriched gas flow and airway pressure A nomogram illustrating the relationship between constant airway pressure and 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 Flow Pressure Nomogram for reference only to show typical flow pressure relationships This is not meant to establish actual product performance 16 Chapter 4 Unpacking amp Setup 675 101 101 Rev M User Verification Test WARNING
16. and time triggered BiPhasic modes with and without breath rate monitoring The Comprehensive configuration offers these features plus a patient triggered BiPhasic mode with apnea backup breaths The Infant Flow SiPAP comes standard in all configurations with an LCD touch screen display pressure time waveform graphics integrated patient monitoring alarms for high and low pressure and FiO2 and up to 2 hours of backup battery power As a result of the unique patented design the Infant Flow or AirLifeTM Infant nCPAP System Generator has been proven to provide the most stable CPAP at the lowest work of breathing for patients compared to other devices 1 The outstanding performance of the Infant Flow Generator is irrespective of patient demand or expiratory flows This system has been designed and tested to perform optimally when used only with accessories available from CareFusion These accessories include circuits and generators prong and mask patient interfaces and bonnets Infant Flow SiPAP Features The expanded capabilities of the Infant Flow SiPAP Plus and Comprehensive configurations allow for applications to broader range of patients who may otherwise not be candidates for non invasive respiratory support from NCPAP alone 2 3 NCPAP continuous positive airway pressure based on clinician set pressure Breath rate monitoring alarm can be activated in this mode BiPhasic time triggered pressure assists are
17. 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 be cancelled to alert the operator of the new alarm condition Resetting alarms Press the Alarm Mute Reset button for 3 seconds to clear resolved and LOW Priority alarms and to reset alarm limits i e after a control setting change Where the alarm cause remains the appropriate alarm will immediately reoccur Audible alarm priority High Priority a series of 10 tones 2 groups of 3 tones followed by a pause and 2 more tones every 10 seconds Medium Priority three audible tones every 15 seconds Low Priority two audible tones every 30 seconds 36 Chapter 7 Alarms and Indicators 675 101 101 Rev M Alarm Types The following alarm systems are provided with the Infant Flow SiPAP Electronic alarms are set after 2 minutes of operation without operator intervention although the operator can manually set or reset them if required Refer to Appendix C for information on troubleshooting alarms Supply Gases Failure If the differential pressure between the two inlet gases falls outside of the limit of 30 PSI 2 0 bar or one gas fails completely an alarm will sound and
18. pressure levels This mode currently not available in the United States BiPhasic tr Apnea BiPhasic tr with Low Breath Rate monitoring non US labeling This mode currently not available in the United States NCPAP Nasally applied CPAP NCPAP LBR 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 monitor alarm time US labeling both in seconds This mnemonic may also be associated with an alarm icon T High Length of time in seconds for a sigh or manual breath Time High US labeling Labeling using English text in place of symbols and or icons Non US labeling Labeling using non linguistic symbols in place of English text wherever possible PEEP Positive End Expiratory Pressure PIP Peak Inspiratory Pressure Pres Low Adjustable lower baseline pressure level control in BiPhasic and BiPhasic tr modes Pres High Adjustable upper pressure level control in BiPhasic and BiPhasic tr modes 64 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 65 675 101 101 Rev M Index A Absominal Respirato
19. then pressing the control again to confirm the change Figure 11 Parameter Adjust Screens 30 Chapter 5 Operation 675 101 101 Rev M 5 Main screen The Main Screen provides the operator with displays of current mode of operation alarm status battery charge status monitored parameters and a pressure time graphic display Active controls are available for adjustment in this screen Figure 12 Main Screen 6 Monitored Parameter Screen This screen is accessed by pressing 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 13 Monitored Parameters Screen Chapter 5 Operation 31 675 101 101 Rev M Step by Step Fixation for Infant Flow System Generators Following this fixation technique closely helps to ensure Enhanced stability of the Generator Minimal disturbance to the infant WARNING Do not attach Generator to the patient until User Verification and initial set up into NCPAP mode is complete Patient Interfaces from CareFusion accommodate a wide range of patients Application of an incorrectly sized prong mask or bonnet will affect stability of the generator The clinician may consider alternating the use of prong and mask interfaces at set intervals for a singl
20. 5 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 40 61 to 87 PSI Maximum differential pressure 29 PSI Manometer Range 0 to 20 cmH2O accuracy 2 of span Gas Connections Standard DISS NIST or Air Liquide connectors Electrical Supply Input Voltage 100 230 VAC Input Frequency 50 60 Hz Power Consumption 50 VA maximum Fuse Rating For 220 V nominal operation T Type 2 5 A at 250 V Device Housing Protection rating level IPX1 Battery Working Time 2 hours from fully charged state Battery Charging Time max 16 hours Chapter 2 Product Specifications 5 675 101 101 Rev M Atmospheric amp Environmental Temperature Range Operating 5 40 C Storage 20 50 C Relative Humidity Operating 0 95 non condensing Storage 0 95 non condensing Physical Dimensions Driver only W x H x D 26 x38 x 23 5 cm W x H x D 10 25 x15 x 9 25 in Weight Driver only 8 8 kg 19 5 lb Accessories Silencer Bacterial Filter The additional resistance of the 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 6 Chapter 2 Product Specifications 675 101 101 Rev M Infant Fl
21. all modes User Interface Display Screen Displays 1 Set Up Screen The Set Up screen prompts the user to confirm settings for base line pressure level NCPAP Pres Low O2 upper level pressure Pres High controls and confirmation of connection of the Transducer Interface XDCR to the driver Figure 8 Set Up Screen Adjust the NCPAP Pres Low flow meter counter clockwise to increase the control to the required flow rate and clockwise to decrease the flow Touch the associated flashing icon to confirm The icon changes to a check mark and the next button flashes Set the O2 as prescribed Touch the associated 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 28 Chapter 5 Operation 675 101 101 Rev M If breath rate monitoring is desired attach the Transducer Interface and the abdominal sensor Refer to Chapter 4 for instructions on application of the Abdominal Respiratory Sensor Touch the flashing button to confirm If an alarm is activated as a result of any of the settings the button displays a flashing X Alarm conditions must be cleared and all settings must be confirmed
22. and alarms disable Chapter 9 Explanation of Symbols 47 675 101 101 Rev M 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 48 Chapter 9 Explanation of Symbols 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 49 675 101 101 Rev M Appendix A Product Configurations Non US Configuration Parameters Table 7 Non 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 Pres High flow rate 0 5 15 L min N A BiPhasic BiPhasic tr on time T High 0 1 3 0 0 005 seconds 3 sec BiPhasic rate R mandatory rate 1 120 0 5 bpm 30 bpm BiPhasic tr backup rate Rb apnea backup rate 1 120 0 5 bpm 10 bpm Apnea timeout Tapnea 10 30 1 seconds 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 8 US Configuration Parameters Parameter Min Max Accuracy Units Default Set Oxygen concentration O2 21 100 3 N A NCPAP Pre
23. apter 7 Alarms and Indicators 37 675 101 101 Rev M Flat Battery If the battery charge is too low to reliably power the analogue and valve driver circuits the unit enters a safe flat battery screen until it is either switched off or plugged into a suitable external power source The screen display will go completely blank when the battery charge is too low to power it While sufficient power is available audible and visual indication of the high priority alarm is maintained Figure 17 Flat Battery screen Operation without Electrical 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 failure then a non mutable HIGH priority alarm is activated with the error code displayed in flashing RED text in the upper right hand of the display screen alternating with any currently displayed mode information Refer to Appendix D for a listing of error codes Remove driver from service and refer to a qualified service technician 38 Chapter 7 Alarms and Indicators 675 101 101 Rev M Alarm Symbols and Indicators The following displays are shown within the graphica
24. arm Refer to Service Engineer Low battery voltage lt 11 10 V for 5 seconds Medium Battery disconnected Battery failing to hold charge Push Alarm Mute button for 3 seconds to silence alarm Connect AC power AC power disconnected High AC power disconnected Push Alarm Mute button for 3 seconds to silence alarm Reconnect the AC power High NCPAP Pres Low CPAP gt 3 cmH2O above set for 15 seconds High NCPAP Pres Low setting change Circuit disconnect reconnect Push Alarm Mute button for 3 seconds to silence and reset alarm limits Reset alarm limits after setting change and patient circuit disconnect reconnect Low NCPAP Pres Low CPAP lt 2 cmH2O below set for 15 seconds or lt 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 circuit disconnect reconnect Check for leaks in patient circuit High BiPhasic or BiPhasic tr pressure MAP gt 3 cmH2O above set for 15 seconds High Pres High setting change Circuit disconnect reconnect Push Alarm Mute button for 3 seconds to silence and reset alarm limits Reset alarm limits after setting change and patient circuit disco
25. ate and detection of apneic episodes as well as an appropriate monitor for continuous SaO2 monitoring If the Infant Flow SiPAP driver is shelf mounted ensure that the driver is stable and that all circuit tubing hoses and cables are restrained to avoid hazard of toppling Check that the water trap is empty before use and empty it frequently during use Do not block or restrict the exhaust port located on the instrument back panel Equipment malfunction may result Chapter 3 Summary of Warnings and Cautions 9 675 101 101 Rev M Do not use the equipment without the expiratory tubing connected to the generator Only use the supplied AC cable to connect to the power supply The Transducer LED indicator on the front panel of the driver only signifies connection to the driver It does not indicate connection to or proper positioning of the Abdominal Respiratory Sensor Do not overload the pole and stand Oxygen vigorously accelerates combustion To avoid explosion hazard do not use any instrument or other equipment that may have been exposed to oil or grease contamination When a low gas supply alarm occurs the oxygen concentration delivered to the patient will differ from that set on the O2 control A source gas failure will change the FiO2 and may result in patient injury The functioning of this equipment may be adversely affected by the operation of other
26. ays as tabulated in appendix D and a high priority alarm is indicated visually and audibly To enable continued operation the internal oxygen monitoring may be disabled by pressing and holding the alarm mute reset button for 3 seconds This disables the internal oxygen monitor and alarms and clears the alarm condition The E5X code remains to indicate that the oxygen monitor is inoperative An external oxygen monitor must be used 18 Chapter 4 Unpacking amp Setup 675 101 101 Rev M Leak Test 1 Have the patient circuit and generator assembled as shown in Fig 3 2 Connect the patient interface prong or mask to the generator see Chapter 5 Step by Step Fixation and occlude the opening to the patient 3 If not powered up already switch on the power to the driver 4 Adjust the NCPAP Pres Low flow meter to 8 L min Verify that the measured pressure is 5 1 cmH2O Touch the associated flashing screen icon to confirm 5 Adjust O2 control as 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 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 8 The dis
27. ce when operated in the intended use environments e g hospitals described in this 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 Electrical Safety Class 1 equipment Contains type BF patient applied parts Continuous Operation MR I 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 Intended Us e Notice The Infant Flow SiPAP consisting of a Driver and Generator plus NCPAP Prongs and Masks is intended for the provision of Bi Level CPAP SiPAP to produce a sigh The system is for use in Hospitals Hospital Type facilities and intra Hospital transport environments and is indicated for the treatment of Newborn and Infant patients The Infant Flow SiPAP should only be operated by properly trained clinical personnel under the direction of a physician x Infant
28. delivered based on clinician set Time High rate and pressure criteria Breath rate monitoring alarm can be activated in this mode BiPhasic tr patient triggered pressure assists delivered based on clinician set Time High and pressure criteria Breath rate monitoring alarm and Apnea backup breaths are automatically active in this mode Patented Infant Flow or AirLifeTM Infant nCPAP System Generator The Infant Flow Generator is a fluidic device for the generation of consistent infant nasal CPAP with a low work of breathing compared to other devices 1 Fully integrated alarm package Supply gases failure High Patient Pressure Low patient pressure high and low delivered Oxygen concentration change from AC to DC power source low and flat battery charge status and Low breath rate apnea alarm Battery Backup Up to 2 hours of battery backup allows for intra hospital transport Clear indicators are provided for power supply in use AC or DC and battery charge level 2 Chapter 1 Product Description 675 101 101 Rev M 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 access to controls Table 1 Functions and Accessories Functions amp Accessories Plus Comprehensive NCPAP NCPAP with breath rate monitoring and alarm
29. dicates the equipment is suitable for alternating current Symbol 5007 IEC 60417 Symbol 01 01 IEC 60878 Indicates ON Power Symbol 5008 IEC 60417 Symbol 01 02 IEC 60878 Indicates OFF Power MDD Directive 93 42 EEC CE Mark CareFusion Symbol This symbol indicates an INTERNAL BATTERY FUSE 44 Chapter 9 Explanation of Symbols 675 101 101 Rev M Symbol Source Compliance Meaning ISO 7000 2004 2616 Electrical AC inlet ISO 15223 2000 3 11 EN 980 2003 5 7 3 Operating temperature range of unit 2 5A T 250 V 101010 N A Fuse holder and fuse rating XDCR CareFusion Symbol Transducer Assembly IEC 60878 1988 01 41 ISO 7000 2004 2301 Warning Bell 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 2003 4 2 Single Use Only Do NOT Re use Chapter 9 Explanation of Symbols 45 675 101 101 Rev M Symbol Source Compliance Meaning ISO 15223 2000 3 8 Keep Dry ISO 15223 2000 3 8 Keep Away from Heat Symbols used on buttons The following symbols ar
30. e recalibrated by user bad offset or high gain Possible fuel cell electronic blender or gas supply fault No oxygen monitor High priority alarm Error E prompt User Check gas supplies Service Fix sensor circuits blender E52 Oxygen sensor calibrates but the fuel cell is worn out low gain Oxygen sensor readings unreliable No oxygen monitor High priority alarm Error E prompt User Check gas supplies Service Replace sensor E53 Oxygen sensor too noisy to calibrate calibration timeout Oxygen sensor readings unreliable No oxygen monitor High priority alarm Error E prompt User Check gas supplies Service Fix sensor circuits blender E54 Oxygen calibration may be invalid O2 reading below 17 or above 104 detected Oxygen sensor readings unreliable 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 BiPhasic valve activation fault via sense BiPhasic modes unusable Restricted Restricted mode Error E alarm Service Fix valv
31. e circuits PT transducer disconnected Apnea and or patient trigger unusable interrup ted Un triggerable NCPAP and BiPhasic modes with breath monitoring on inhibited or low breath rate alarm given if treatment started User Reconnect PT transducer E70 PT module fault PTRDY or CAN bus failure Apnea and patient trigger unusable Un triggerable Reduced functionality E alarm Service Fix PT circuits E71 No breath signal from PT module although CAN data does not report Apnea Patient may be in apnea but PT module dysfunctional Untriggera ble Reduced functionality E alarm Service Fix PT circuits E72 No trigger signal from PT module BiPhasic tr mode inoperable Untriggera ble Reduced functionality E alarm Service Fix PT circuits Appendix D Fault Management 61 675 101 101 Rev M E Fault condition Consequence Clas sification Software Response Corrective Action Required E9 0 Spurious software interrupt XTAL fails stack overflow underflo w CPU Class B exception Software interrupted and restarts possibly during treatment Spurious Hardware reinitialized disabled with alarm bar lit and beeper sounding to identify root cause Software Fix persistent exceptions E90 Abnormal hardware software or watchdog reset Software restarts possibly during treatment Spurious Software
32. e patient in order to change pressure points on the infant s face and reduce the risk of skin breakdown 1 Measure for prong mask size using the nose guide Connect the interface to the generator 2 Measure for bonnet size from the middle of the forehead to the nape of the neck and then back to the middle forehead DO NOT use a head circumference 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 neck Switch on the power to the driver and complete Set Up Screen steps to enter NCPAP mode with the prescribed settings for the current patient 5 Lift the Generator from the top of the bonnet and bring towards the nose Gently insert the nasal prongs mask into position while supporting the Generator Secure the generator straps horizontally across the infant s cheeks Do not over tighten 6 Secure all three tubes from the Generator with the central Velcro strip Split the inspiratory and pressure lines and secure with secondary Velcro strips Tie the open end of the bonnet if desired 7 Final check Nose in neutral position eyes visible ears not folded Desired upper and low
33. e regarding the 2nd Flow Meter being used for manual breath delivery Added hyphen in T High Clarified the Mode Select Screen Added Directions for using the AirLifeTM Infant nCPAP System Changed 1 cmH2O to 1 5 cmH2O Corrected low battery voltage level from 10 to 11 10 Added or trained biomedical engineer Added a table entry for the oxygen monitor and alarms disable Changed 1 cmH2O to 1 5 cmH2O corrected low battery voltage level from 10 to 11 10 Updated Table 10 Updated Table 11 Clarified the meaning of T High February 2010 J Revised to comply with the revised Medical Device Directive 2007 42 EC Infant Flow SiPAP v 675 101 101 Rev M Date Revision Changes March 2010 K Rebranded the manual to the CareFusion style Updated the part number table January 2011 L Changed the logo and company references to VIASYS January 2011 M Changed the logo and company references to CareFusion vi Infant Flow SiPAP 675 101 101 Rev M Warranty Infant Flow SiPAPTM 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 The liability of CareFusion Corporation referred to as the Company under this warranty is limited to replacing repairing or issuing credit at the discretion of the Company for parts that become defective or fail to meet published specifications durin
34. e 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 non US configuration displays right hand column Table 6 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 timeout Adjust BiPhasic BiPhasic tr on time and NCPAP manual breath function 46 Chapter 9 Explanation of Symbols 675 101 101 Rev M Symbol Description Decrease Increase currently selected parameter Go to mode select screen Nasal CPAP mode 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 BiPhasic cycle at current settings for T High Pres High and O2 One 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
35. ed 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 60 Appendix D Fault Management 675 101 101 Rev M E Fault condition Consequence Clas sification Software Response Corrective Action Required E50 Oxygen sensor fault ADC hits rail Oxygen sensor readings invalid No oxygen monitor High priority alarm Error E prompt Service Fix sensor circuits E51 Oxygen sensor can not b
36. equipment nearby such as high frequency surgical diathermy equipment defibrillators short wave therapy equipment walkie talkies or cellular phones Due to possible explosion hazard the Infant Flow SiPAP should not be used in the presence of flammable anesthetics Electric shock hazard Do not remove any of the Infant Flow SiPAP covers or panels Refer all servicing to an authorized 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 cord into a properly wired receptacle use only the power cord supplied with the ventilator and make sure the power cord is in good condition The Infant Flow SiPAP is designed to ensure that the user and patient are not exposed to excessive leakage current per applicable standards However this cannot be guaranteed when external devices are attached to the driver In order to prevent the risk of excessive enclosure leakage current from external equipment attached to the driver isolation of the protective earth paths must be provided to ensure proper connection This isolation should ensure that the cable shields are is
37. er pressure levels and FiO2 are delivered Infant settles quickly after fixation 32 Chapter 5 Operation 675 101 101 Rev M Every hour Repeat checks listed above in Final Check Every 3 4 hours Loosen the generator straps and release the tubes from the central Velcro strip The nasal area can be cleaned with warm sterile water Do not apply creams or ointments Ensure that Nasal prongs mask is not occluded with mucus water droplets Patient prongs mask and bonnet continue to fit appropriately Re apply the generator as described above Directions for using the AirLife Infant nCPAP System Please refer to P N 36 5569 included in the AirLifeTM Infant nCPAP Fixation Device for the Directions for Use WARNING CareFusion consumables are specifically designed to be used with Infant Flow Drivers and are the only consumables validated for use with Infant Flow devices Infant Flow SiPAP 33 675 101 101 Rev M Chapter 6 Operating Modes NCPAP The Nasal CPAP mode can be enabled to have breath rate monitoring displayed NCPAP Apnea Mode or NCAP LBR Mode or the system can operate without having the breath rate monitoring 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 14 NCPAP BiPhasic Allows for time triggered pressure assists w
38. g the warranty period the Company will not be liable under this warranty unless A the Company is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications B the defective unit or part is returned to the Company transportation charges prepaid by Buyer C the defective unit or part is received by the Company for adjustment no later than four weeks following the last day of the warranty period and D the Company s examination of such unit or part shall disclose to its satisfaction that such defects or failures have not been caused by misuse neglect improper installation unauthorized repair alteration or accident Any authorization of the Company for repair or alteration by the Buyer must be in writing to prevent voiding the warranty In no event shall the Company be liable to the Buyer for loss of profits loss of use consequential damage or damages of any kind 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 products furnished hereunder Limitation of Liabilities This warranty does not cover normal maintenance such as cleaning adjustment or
39. icator Two Point O2 Sensor Calibration Enter the Calibration Screen from the Set Up Screen by pressing the calibration button on the lower right hand corner of the touch screen Ensure there is a minimum 8 LPM set on the NCPAP PRES Low Flow meter In addition ensure there is a minimum of 3 LPM set on the NCPAP High Flow meter Adjust the O2 control to 21 Allow the O2 display to stabilize Confirm the calibration by touching the associated flashing button Adjust the O2 control to 100 Allow the O2 display to stabilize Confirm by touching the associated flashing button Return to the Start up Screen by pressing the Exit button Note If O2 calibration fails a red X is shown Refer to the Service Manual If the internal oxygen cell is depleted or damaged it may not be possible to calibrate the O2 sensor 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 E5x displays and measured FiO2 displays as dashes WARNING When the Infant Flow SiPAPTM unit is connected to a patient and the internal oxygen monitor is disabled the Infant Flow SiPAPTM unit must be used with an external oxygen monitor If calibration is attempted and fails or if the oxygen cell fails while the device is in normal use a Fault Code E5X displ
40. igh 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 accuracy 15 of selected output Manual Breath X 1 O2 21 100 Monitors CPAP PEEP MAP PIP O2 I E ratio Spontaneous rate Rsp Battery charge level 4 Chapter 2 Product Specifications 675 101 101 Rev M Alarms High airway pressure 3 cmH2O above measured airway pressure Airway over pressure limit alarm maximum 11 cmH2O in NCPAP and time triggered BiPhasic mode maximum 15 cmH2O in patient triggered BiPhasic tr mode Low airway pressure 2 cmH2O below measured airway pressure or 1 5 cmH2O if otherwise would be zero High and Low delivered Oxygen concentration 5 of setting Minimum and maximum delivered FiO2 is 18 and 104 respectively Low breath rate alarm Low battery charge level Flat battery Input gases failure Alarm volume electronic alarms 70 dBa at 1 meter Pneumatic Supply Patient Gas Outlet 1
41. ith or without breath rate monitoring and adjustable low breath rate alarm delivered based on clinician set Time High T High criteria rate and pressure settings Figure 15 BiPhasic 34 Chapter 6 Operating Modes 675 101 101 Rev M BiPhasic tr Allows for patient triggered 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 16 BiPhasic tr This mode available in Comprehensive configurations only Infant Flow SiPAP 35 675 101 101 Rev M Chapter 7 Alarms and Indicators Audible and visual indications are given to alert the Operator to specified conditions that affect operation The electronic alarm limits are automatically set after two minutes without the necessity of Operator inputs Alarms can be manually set at any time if required i e after settings change or patient disconnect reconnect by pressing the Alarm Mute Reset button for 3 seconds Alarm Priority On activation of a MEDIUM or HIGH priority alarm a locked screen will automatically revert to the unlocked display The alarm status indicator flashes intermittently based on the current highest alarm priority Distinct audible alarms represent a HIGH MEDIUM or LOW priority alarm Measured parameters and alarm limits associated with a high
42. l display As needed displays in this table are shown separately as Domestic US configuration displays left hand column and non US configuration displays right hand column Table 4 Alarm Symbols and Indicators Indicator Meaning Battery status charge level Green indicates full charge red indicates charge lt 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 checks that the Pres High flow meter should be set as desired and pressure verified Indication during pre use checks and or calibration that O2 should be set and verified Chapter 7 Alarms and Indicators 39 675 101 101 Rev M Indicator Meaning Indication during pre use checks that operator should attach the respiratory sensor cross indicates that transducer assembly is not connected Indication during pre use checks that the operator should attach the respiratory sensor indicates that transducer assembly is connected 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 ala
43. lternates with worst error code 6 minor No oxygen monitor Oxygen monitor and alarm functions are not available High priority alarm may be cleared by operator reset status bar extended mode alternates with error code Fault recovery action If a detectable fault condition occurs either before treatment begins or while being applied the software will respond in the following way Table 11 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 Reload software Battery too flat lt 6 5V to operate LCD analogue and valve driver circuits no external power No user interface display Unusable Hardware held in reset condition with alarm bar lit status LED off until external power applied User Plug in external power Battery too flat lt 10 25V to operate analogue and valve driver circuits but sufficient for LCD driver no external power Sensor readings invalid Unusable User lockout Plug in external power prompt User Plug in external power Appendix D Fault Management 59 675 101 101 Rev M E Fault condition Consequence Clas sification
44. lubrication and updating of equipment parts This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured by the Company or authorized for use in writing by the Company or if the equipment is not maintained in accordance with the prescribed schedule of maintenance The warranty stated above shall extend for a period of One 1 year from date of shipment with the following exceptions 1 Components for monitoring of physical variables such as temperature pressure or flow are warranted for ninety 90 days from date of receipt 2 Elastomeric components and other parts or components subject to deterioration over which the Company has no control are warranted for sixty 60 days from date of receipt 3 Internal batteries are warranted for ninety 90 days from the date of receipt The foregoing is in lieu of any warranty expressed or implied including without limitation any warranty of merchantability except as to title and can be amended only in writing by a duly authorized representative of the Company Infant Flow SiPAP vii 675 101 101 Rev M Contents Revision History iii Warranty vi Contents
45. nding confirmation is visually highlighted and intermittently flashes between yellow and white text While a button is pressed the edges are highlighted to provide 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 limit displayed in YELLOW until the alarms are cleared by the operator When parameter adjustments cause a reduction in another parameter to maintain requirements for minimum breath interval the reduced parameter is displayed in RED for 15 seconds Changing a control When a control such as Time High is selected increase and decrease buttons appear The control and the displayed value for the selected parameter are highlighted Use the decrease or increase keys to adjust the parameter You may accept the action by pressing the control button again If no action is taken the new parameter will take effect after 15 seconds In normal treatment screens parameter changes take immediate effect When you change the mode such as NCPAP to BiPhasic press the flashing mode button to accept the change If no screen interactions occur for a period of 120 seconds and there are not acti
46. nnect reconnect BiPhasic or BiPhasic tr mode fails to operate as set High Cannot be silenced See description of error code displayed Revert to nCPAP mode Refer to Service Technician Appendix C Alarm Troubleshooting 55 675 101 101 Rev M Alarm Priority Possible Cause Actions Low breath rate High Plus audible visual alarms only Comprehensive audible visual alarms and backup rate Rr 0 for gt low breath apnea interval timeout Push Alarm Mute button once to silence alarm Restore patient breathing Check placement connection of abdominal Respiratory Sensor Flow meter fault N A No flow indications Flow can t be adjusted Refer to Service Technician Gas Supply failure N A Differential pressure between the two inlet gases falls outside of the limit of 30 PSI 2 0 bar or one gas fails completely Check gas inlet supplies Check inlet water trap Refer blender to service technician Oxygen cell calibration error Oxygen cell incorrectly calibrated damaged or depleted Calibrate or replace oxygen cell Refer to Service Manual Electrical fault AC power LED does not match screen icon Refer to Service Technician Water trap blocked Full or leaking Filter blocked Loss of wall pressure Imbalance in gas supply
47. nt connections or other ports CAUTION Do not immerse any part of the Infant Flow SiPAP driver in water or sterilize it with gas or steam Maintenance No special maintenance 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 combustion To avoid explosion hazard do not use any instrument or other equipment that may have been exposed to oil or grease contamination Calibrate the oxygen analyzer regularly Calibration of the oxygen analyzer must be done with the unit off patient Regularly check and empty the water trap accessed from the rear panel of the driver enclosure Push the button on the bottom of the water trap to release the water into a suitable waste receptacle Disconnect the air and oxygen gas sources when the Infant Flow SiPAP is not in use 42 Chapter 8 Maintenance amp Cleaning 675 101 101 Rev M Storage and Battery Care Store the unit in a clean dry location Make sure that all connections 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 batte
48. olated at the peripheral end of the cable When the Infant Flow SiPAPTM unit is connected to a patient and the internal oxygen monitor is disabled the Infant Flow SiPAPTM unit must be used with an external oxygen monitor 10 Chapter 3 Summary of Warnings and Cautions 675 101 101 Rev M Cautions Before use verify that this equipment has been authorized for use by qualified technical service personnel Ensure that the voltage and installed fuses are set to match the voltage of the wall outlet or damage may result A battery that is fully drained i e void of any charge may cause damage to the driver and should be replaced All accessory equipment that is connected to the driver should comply with CSA IEC601 ETL Although failure of any of the above tests will not prevent the ventilator from functioning it should be checked to make sure it is operating correctly before use on a patient The Infant Flow SiPAP has been designed and tested using only CareFusion accessories Only accessories 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 driver or pour cleaning liquids over or into the driver Following each alarm ve
49. ow SiPAP Infant Flow SiPAP 7 675 101 101 Rev M 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 Notes are also located throughout the manual to provide additional information related to specific features If you have a question regarding the installation set up operation or maintenance of the device contact CareFusion see page v Terms WARNINGS identify conditions or practices that could result in serious adverse reactions or potential safety hazards CAUTIONS identify conditions 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 is intended for use by a trained practitioner under the direct supervision of a qualified physician When the Infant Flow SiPAP is connected to a patient a trained health care professional should be in attendance at all times to react to an alarm or other indications of a
50. piratory Care template using VIASYS Respiratory Care nomenclature Revise part number list in Appendix B approved accessories November 2004 E Revised contact ordering information Ch 4 Sec 5 b revised transducer LED illumination conditions Appendix A corrected units from Pm to bpm Appendix E added dimension ranges to bonnet sizes Appendix E Was 467350 Transducer Assembly Is 677 002 Transducer Interface March 2005 F Updated the contact information Updated the Declaration of Conformity Notice May 2006 G Updated the company name Updated the Contact and Ordering Information Update the figures Added a Caution regarding 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 of manual breath or back up apnea breath Added a warning concerning infant flow consumables Added the statement Disconnect the air and oxygen gas sources when the Infant Flow SiPAP is not in use Removed Appendix E February 2009 H Changed Ti to T High and Inspiratory Time to Time High Replaced reference to VIASYS Respiratory Care accessories with refe
51. play screen changes to the Alarm Set Confirm Screen Press the NCPAP button or Alarm Mute Reset button to set alarms and begin monitoring 9 Monitored parameter for CPAP should be 4 5 cmH2O If not check circuit for leaks or blockages including the humidification system 10 Remove the occlusion to the patient interface The monitored CPAP display should be 0 2 cmH2O If not check that the interface is not still occluded Chapter 4 Unpacking amp Setup 19 675 101 101 Rev M Alarms Test WARNING Prior to patient application ensure that all User Verification testing and calibration procedures are successfully completed User Verification testing and calibration procedures must be done off patient NOTE Following each alarm verification 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 gt 30 psig 2 1 bar O2 Supply Pressure gt 30 psig 2 1 bar Patient Circuit Infant Flow or AirLifeTM Infant nCPAP System Patient Circuit Generator Infant Flow or AirLifeTM Infant nCPAP System Generator NCPAP Pres Low flow meter 8 L min for delivery of 5 cmH2O O2 30 Pres High flow meter 3 L min Mode NCPAP For Step 9 Use the settings provided below Rate 30 bpm T High 0 3 sec Tapnea Non U S Configuration TLBR U S Configuration 20 sec 20 Chapter 4 Unpacking amp
52. problem Always have an alternate means of ventilation available whenever the Infant Flow SiPAP is in use Do not attach the Generator to the patient until User Verification and initial set up into NCPAP mode is complete Water in the air supply can cause malfunction of this equipment The operator should not touch the electrical connectors of the Infant Flow SIPAP or its accessories and the patient simultaneously An audible alarm indicates an anomalous condition and should never go unheeded 8 Chapter 3 Summary of Warnings and Cautions 675 101 101 Rev M Anti static or electrically conductive hoses or tubing should not be used within the patient circuit If a mechanical or electrical problem is recognized while operating the Infant Flow SiPAP it must be removed from use and referred to qualified service personnel for servicing Using inoperative equipment may result in patient injury Prior to patient application ensure that all User Verification testing and calibration procedures are successfully completed User Verification testing and calibration procedures must be done off patient The indicates a connection between the Transducer Assembly and the driver It does not indicate attachment or correct positioning of the Abdominal Respiratory Sensor Under certain conditions minimum supply pressure and maximum gas demand including auxiliary output o
53. rence to Cardinal Health accessories Added TM superscript to SiPAP Added reference to AirLifeTM Infant nCPAP System Generator Removed inspiratory time or inspiration time Replaced Inspiratory Time Time High with Time High iv Infant Flow SiPAP 675 101 101 Rev M Date Revision Changes Thigh Changed 1 cmH2O to 1 5 cmH2O Added or 60 psi to clarify 4 bar Added the parts list for both Infant Flow Products and AirLifeTM Products Added reference to Cardinal Health contact information on page v Added reference to AirLifeTM Infant nCPAP System accessories Added a warning about using an external oxygen monitor Added reference to factory trained technician and Service Manual P N 675 120 Added registered symbol superscript to Infant Flow Updated CAUTION label from Back pressure from the humidifier chamber to some auto feed water bags may occur To Back pressure from some auto feed humidifier chambers may cause the water bags to fill with air Replaced Figure 5 Add content 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 Not
54. 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 consequence of the problem Biphasic tr mode not currently available in the United States Fault code display screen The fault lockout screen shall incorporate item ref as appropriate to build and shall display a list of all active fault codes Faults not resulting in user lockout shall result in indication on the status bar 62 Appendix D Fault Management 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 63 675 101 101 Rev M Glossary Term Meaning Apnea Temporary inability to breathe LBR Low Breath Rate Bpm Breaths per minute applies to each of spontaneous triggered and mandatory CPAP Continuous Positive Airway Pressure Generator Patient attachment for delivering CPAP used with nasal prongs or mask BiPhasic Time triggered time cycled pressure assists at two separate pressures levels BiPhasic LBR BiPhasic with Low Breath Rate monitoring US labeling BiPhasic tr Patient triggered time cycled pressure assists at two separate
55. rification test ensure that control settings and alarm limits are reset as instructed before proceeding to the next test Notes CareFusion cannot ensure product performance as stated in this manual with the use of Non CareFusion accessories Infant Flow SiPAP 11 675 101 101 Rev M Chapter 4 Unpacking amp Setup Assembly and physical setup Figure 1 Stand unpacking and assembly Optional Accessory 12 Chapter 4 Unpacking amp Setup 675 101 101 Rev M Figure 2 Stand and Driver assembly Optional Accessory Infant Flow SiPAP Driver Chapter 4 Unpacking amp Setup 13 675 101 101 Rev M Attaching a patient circuit Figure 3 Driver assembled with patient circuit and humidifier Note We recommend between 96 8 F 36 C and 98 6 F 37 C but never higher than 98 6 F 37 C for inspired gases Optional Accessory Infant Flow SiPAP Driver 14 Chapter 4 Unpacking amp Setup 675 101 101 Rev M CAUTION Back pressure from some auto feed humidifier chambers may cause the water bags to fill with air Ensure that the humidifier chambers are adequately filled according to the manufacturer s instructions Note When the Hudson RCI Humidification System is being used with Infant Flow SiPAPTM it is recommended that the standard compliance column be used Attaching the Abdominal Respiratory Sensor Figure 4 Attaching the Abdominal
56. rms 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 parameter Rate BiPhasic modes only mandatory rate Set parameter RB BiPhasic tr mode only backup rate Set parameter low breath rate or apnea alarm timeout 40 Chapter 7 Alarms and Indicators 675 101 101 Rev M Indicator Meaning Display of measured airway pressure graph With breath monitoring active spontaneous breaths are 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 Infant Flow SiPAP 41 675 101 101 Rev M Chapter 8 Maintenance amp Cleaning Cleaning Examine the exterior of the case and the stand for damage and dirt If necessary clean the unit and stand If damage to either is apparent always seek qualified Technical advice Clean the exterior surfaces of the driver Transducer Assembly and stand with a mild soap or liquid disinfectant solution Do not use cleaning agents that contain abrasives Make sure that cleaning agents do not enter the driver through patie
57. ry 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 Infant Flow SiPAP 43 675 101 101 Rev M Chapter 9 Explanation of Symbols Equipment Symbols The following symbols may be referenced on the Infant Flow SiPAP driver or in accompanying documentation Table 5 Equipment Symbols Symbol Source Compliance Meaning Symbol 03 02 IEC 60878 Indicates ATTENTION consult ACCOMPANYING DOCUMENTS Symbol 5016 IEC 60417 This symbol indicates a FUSE 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 necessarily being the earth ground potential e g for local bonding Symbol 5333 IEC 60417 Symbol 02 03 IEC 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 Symbol 5032 IEC 60417 Symbol 01 14 IEC 30878 This symbol is located on the rating plate It in
58. ry Sensor 14 Accessories 2 airway pressure 15 alarm priority 35 Alarm set confirm Screen 28 Alarm Symbols 38 alarms 4 Alarms 35 Alarms Test 19 assembly 11 B Battery Backup 1 Battery Care 42 BiPhasic 1 33 BiPhasic tr 1 34 button symbols 45 C calibration O2 sensor 17 cautions 7 Circuit Occlusion Alarm 20 classification x Cleaning 41 configuration Comprehensive 1 Plus 1 Configurations 49 control buttons 25 controls 3 D decrease buttons 26 E electrical supply 4 electromagnetic components ix EMC ix environmental requirements 5 Error code indication alarm 37 F fault lockout screen 61 faults 57 features 1 fixation 31 Flat Battery alarm 37 front panel 23 Fully integrated alarm package 1 G gas flow 15 H High Airway Pressure alarm 36 High and Low O2 alarm 36 High Patient Circuit Pressure alarm 36 I incompatible control settings 26 increase buttons 26 Indicators and Controls 23 intended use ix L Leak Test 18 Low Airway Pressure alarm 36 Low Battery Charge alarm 36 Low Battery Voltage alarm 36 M Main Screen 30 Maintenance 41 manual breath setting 26 Mode Confirm Screen 29 modes 3 Monitored Parameter Screen 30 monitors 3 MRI ix N NCPAP 1 33 notes 7 O O2 sensor calibration 17 Operating Modes 33 Operation without Electrical Power alarm 37 66 Index 675 101 101 Rev M P Parameter Adj
59. s Low flow rate 0 15 15 L min N A Pres High flow rate 0 5 15 L min N A BiPhasic on time T High 0 1 3 0 0 005 seconds 1 0 sec BiPhasic rate R Mandatory rate 1 54 0 5 bpm 10 bpm Low Breath Rate timeout TLBR 10 30 1 Seconds 20 sec Note In US configurations T High automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 1 0 seconds 50 Appendix A Product Configurations 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 51 675 101 101 Rev M Appendix B Pneumatic Diagram 52 Appendix B Pneumatic Diagram 675 101 101 Rev M Infant Flow SiPAP Infant Flow SiPAP 53 675 101 101 Rev M Appendix C Alarm Troubleshooting Table 9 Alarm Troubleshooting Alarm Priority Possible Cause Actions O2 lt 18 High O2 calibration required Restore FiO2 level to above the minimum limit Press Alarm Reset for 3 seconds Recalibrate O2 as soon as practicable O2 gt 104 High O2 calibration required Restore FiO2 level to below the maximum limit Press Alarm Reset for 3 seconds Recalibrate O2 as soon as practicable High O2 gt 5 above setting for 15 seconds High Blender setting changed Supply gas failure Water trap overflow Press Alarm Mute to silence the alarm Correct delivered o
60. the gas at the higher pressure only will be delivered to the patient High Airway Pressure A HIGH priority audible and visual high pressure alarm activates when pressure reaches 3 cmH2O above the measured airway pressure Airway Over Pressure Limit Alarm A HIGH priority audible and visual high pressure alarm activates at 11 cmH2O during NCAP and 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 pressure or at 1 5 cmH2O if this would otherwise be less than zero High and Low O2 HIGH priority audible and visual alarms are provided at 5 of the measured FiO2 with an upper maximum limit of 104 and a lower minimum limit of 18 A low hazard warning occurs at 18 Oxygen or below Low Battery Charge If the battery charge falls below 40 the battery charge indicator changes from green to red as a warning indicator In this instance plug the driver into an approved AC power source Low Battery Voltage If the battery voltage falls to lt 11 10 V for 5 seconds a MEDIUM priority audible and visual alarm is activated In this instance plug the driver into an approved AC power source Ch
61. tlet Verify that the Loss AC alarm activates Reconnect the AC power cord Clear the alarm by pressing the Alarm Mute Reset button 8 High Circuit Pressure Alarm Increase nCPAP pressure to 11 1 cmH2O by increasing the NCPAP PRES Low Flow meter Verify that the High Circuit pressure alarm activates Return NCPAP PRES Low Flow meter to 8 LPM and press the Alarm Mute Silence button for three seconds to reset the alarms 9 Low Breath Rate Apnea Alarm Select and confirm BiPhasic Apnea LBR U S configuration Using the abdominal sensor manually tap the abdominal sensor to simulate a spontaneous breath rate The default mandatory breath rate should be left alone No alarms should be present Change the mandatory rate control setting to 1 bpm and stop tapping the abdominal sensor Verify that the Low Breath rate alarm activates after the default interval of 20 seconds Resume simulating spontaneous breath rate turn the rate control to the default setting and clear the alarm by pressing the Alarm Mute Reset button for 3 seconds Note a transducer must be connected to perform the alarm check Chapter 4 Unpacking amp Setup 21 675 101 101 Rev M Infant Flow SiPAP User Verification Test Checklist Driver Serial Number _____________________ Test Date _________________ TEST PASS FAIL Automated Tests Power On Check Manual Tests Two Point O2 Sensor Calibration Patient Circuit Leak test Manual Alarms Checks
62. to 29 then T High shall reduce automatically to 1 9s If R is then immediately reduced to 28 the previous setting for T High shall be restored Parameter default value on change of mode Some controls are active in more than one operating mode In these instances there is a separate default value for operating modes as illustrated with the following table Settings that are changed by the operator in one specific mode will be maintained if the mode is changed to another mode within the same mode group All defaults shall revert to factory default on power cycling or software restart Setting a Manual Breath The manual breath function 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 Chapter 5 Operation 27 675 101 101 Rev M Table 3 Parameter Default Value Mode Parameter NCPAP NCPAP rate monitoring BiPhasic BiPhasic rate monitoring BiPhasic tr T High Default for NCPAP apply Default for BiPhasic apply Default for BiPhasic tr Rate Default for BiPhasic apply Rb Default for BiPhasic tr Tapnea TLBR This setting applies to all modes system wide default applies to
63. ust Screen 29 parameter default values 26 Patented Infant Flow Generator 1 patient circuit 13 physical specifications 5 Pneumatic Diagram 51 pneumatic supply 4 power on check 16 R radio frequency energy ix Rear Panel 24 reset alarm limits 35 S safety information 7 Screen Displays 27 Screen Lock 2 Set Up screen 27 silence active alarms 35 Silencer Bacterial Filter 5 Soft key operation 25 specifications 3 Storage 42 Supply Gases Failure alarm 36 symbols 43 T Troubleshooting 53 U User Interface 27 User Verification Test 16 User Verification Test Checklist 21 W warnings 7 warranty vi
64. utput flow rates and therefore pressure delivered to the generator may be reduced The Pres High flow meter must be adjusted to zero when not required for the patient 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 alarm conditions may require immediate attention Nasal CPAP treatment in general can cause nasal irritation septal distortion skin irritation and pressure necrosis Adherence to the recommended usage instructions for the Infant Flow SiPAP and AirLifeTM Infant nCPAP System accessories may reduce the incidence of these complications It is strongly recommended that regular monitoring for gastric distention be carried out for patients receiving non invasive ventilatory support Refer to your facility s policy and procedure for further guidance This device exhausts O2 during normal operation Oxygen vigorously accelerates combustion To avoid fire hazard do not place flammable materials or sources of heat close to the exhaust The Abdominal Respiratory Sensor is used only to enable features associated with certain modes from the Infant Flow SiPAP When using the Abdominal Respiratory Sensor always use an additional external device for monitoring of the respiratory r
65. ve alarms then the screen goes to a locked state to prevent inadvertent entries To unlock the screen press the screen lock button In the case of a high priority alarm the screen immediately unlocks to allow access to controls CAUTION When changing a control use only your finger Damage to the touch screen could result if a pen or similar item is used to make changes 26 Chapter 5 Operation 675 101 101 Rev M 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 calculated values such as I E ratio dependent on a control setting change will change with acceptance of the parameter change Incompatible Control Settings When a change to one control requires a change to a separate control to avoid an incompatible control setting the required change is made automatically by the driver software If the adjusted control setting is restored prior to 15 seconds elapsed time or prior to pressing any other control then the required change action is reversed For example in BiPhasic mode with T High 2 0 as R is increased above 28 b min the constraint on minimum T Low can be met only through a reduction in T High If R is increased
66. xygen concentration Press Alarm Reset for 3 seconds to set new limits Low O2 gt 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 gt 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 flow rate to achieve pressure below high pressure limit Press Alarm reset for 3 seconds to set new limits Over pressure gt 15 cmH2O in BiPhasic tr mode High Flow rate set too high Occlusion of exhalation limb Blocked silencer bacteria filter Check exhaust tube filter Reduce flow rate to achieve pressure below high pressure limit Press Alarm reset for 3 seconds to set new limits Low battery charge lt 40 Warning indication Battery status indicator changes from green to red Connect external power 54 Appendix C Alarm Troubleshooting 675 101 101 Rev M Alarm Priority Possible Cause Actions Battery fault High Cannot be reset Battery disconnected Battery failing to hold charge Push Alarm Mute button for 3 seconds to silence al

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