Cardinal Health Infant Flow SiPAP Operator's Manual
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Cardinal Health Infant Flow SiPAP Operator's Manual

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Operator's Manual
®
Infant Flow
SiPAP™
© Copyright 2009 Cardinal Health, Inc.
675-101-101
Revision H

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Summary of Contents for Cardinal Health Infant Flow SiPAP

  • Page 1 Operator’s Manual ® Infant Flow SiPAP™ © Copyright 2009 Cardinal Health, Inc. 675-101-101 Revision H...
  • Page 2 ® Infant Flow SiPAP™ Revision History Date Revision Pages Changes September 2003 675-101(3) Release August 2004 Release manual in VIASYS Respiratory Care template using VIASYS Respiratory Care nomenclature. Revise part number list in Appendix B approved accessories. November 2004 Revised contact/ordering information. Ch 4.
  • Page 3 “or 60 psi” to clarify 4 bar. ® Added the parts list for both Infant Flow Products and AirLife Products. Added reference to Cardinal Health contact information on page v. Added reference to AirLife Infant nCPAP System accessories. Added a warning about using an external oxygen monitor.
  • Page 4 ® Infant Flow SiPAP™ external oxygen monitor must be used. Added a Note regarding the 2 Flow Meter being used for manual breath delivery; Added hyphen in “T-High”. 28, 41, 48, 51 Clarified the “Mode Select Screen” Added “Directions for using the AirLife Infant nCPAP System.

  • Page 5: Contact And Ordering Information

    Operator’s Manual Contact and Ordering Information Authorized European Representative Cardinal Health Cardinal Health Germany 234 GmbH Respiratory Technologies Leibnizstrasse 7 1100 Bird Center Drive 97204 Hoechberg Palm Springs, California 92262-8099 Germany Telephone: 800.231.2466 Telephone: +49.931.4972.0 +1.714.283.2228 Fax: +49.931.4972.423 Fax: +1.714.283.8493 cardinalhealth.com/viasys...

  • Page 6: Warranty

    One (1) year from date of shipment. The liability of Cardinal Health (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 during the warranty period;...

  • Page 7: Table Of Contents

    Operator’s Manual Contents Revision History ..................ii Contact and Ordering Information............v Warranty....................vi Contents ....................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 .......
  • Page 8 viii ® Infant Flow SiPAP™ 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 –...

  • Page 9: Notices

    Trademark Notice ® Infant Flow and SiPAP™ are trademarks of the Cardinal Health group of companies in the United States and some other countries. All other brand names and product names mentioned in this manual are trademarks, registered trademarks, or trade names of their respective holders.
  • Page 10 ® Infant Flow SiPAP™ EMC 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.
  • Page 11 Trade names: ® Infant Flow SiPAP™ Manufactured by: Cardinal Health Respiratory Technologies 1100 Bird Center Drive Palm Springs, CA 92262, USA If you have a question regarding the Declaration of Conformity for this product, please contact Cardinal Health. 675-101-101 Revision H...
  • Page 12 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 13: Chapter 1 - Product Description

    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 Cardinal Health. These accessories include circuits and generators, prong and mask patient interfaces and bonnets.

  • Page 14: Table 1 - Functions And Accessories

    ® Infant Flow SiPAP™ 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 –...

  • Page 15: Chapter 2 - Product Specifications

    Operator’s Manual 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 •...
  • Page 16 ® Infant Flow SiPAP™ Alarms • High airway pressure – 3 cmH O above measured airway pressure • Airway over-pressure limit alarm • maximum 11 cmH O in NCPAP and time triggered BiPhasic mode • maximum 15 cmH O in patient triggered BiPhasic tr mode •...
  • Page 17 Operator’s Manual Atmospheric & 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 •...
  • Page 18 ® Infant Flow SiPAP™ Part No. Description ® Infant Flow Products 777085-102 Legacy Generators - only (box of 20) D1420/100 Silencer (box of 20) F&P 730 11541-101 Patient Circuit Assembly (box of 20) 11541-102 Patient Circuit Assembly w/Generator (box of 20) 773386-101 Patient Circuit (box of 20) 773386-102...

  • Page 19: Chapter 3 - Summary Of Warnings And Cautions

    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 Cardinal Health (see page v). Terms WARNINGS identify conditions or practices that could result in serious adverse reactions or potential safety hazards.
  • Page 20 ® Infant Flow SiPAP™ • 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.
  • Page 21 ® Electric shock hazard – Do not remove any of the Infant Flow SiPAP™ covers or panels. Refer all servicing to an authorized Cardinal Health 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.
  • Page 22 Following each alarm verification test, ensure that control settings and alarm limits are reset as instructed before proceeding to the next test. Notes • Cardinal Health cannot ensure product performance as stated in this manual with the use of Non-Cardinal Health accessories. 675-101-101 Revision H...

  • Page 23: Chapter 4 - Unpacking & Setup

    Operator’s Manual Chapter 4 - Unpacking & Setup Assembly and physical setup Figure 1 – Stand unpacking and assembly 675-101-101 Revision H...

  • Page 24: Figure 2 - Stand And Driver Assembly

    ® Infant Flow SiPAP™ Figure 2 – Stand and Driver assembly 675-101-101 Revision H...

  • Page 25: Figure 3 - Driver Assembled With Patient Circuit And /Humidifier

    Operator’s Manual 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. 675-101-101 Revision H...

  • Page 26: Figure 4 - Attaching The Abdominal Respiratory Sensor

    ® Infant Flow SiPAP™ 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 SiPAP , it is recommended that the standard compliance column be used.

  • Page 27: Figure 5 - Flow Pressure Nomogram

    Operator’s Manual 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 cmH Note Individual devices have a tolerance of up to ±...
  • Page 28 ® Infant Flow SiPAP™ User Verification Test WARNING 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.
  • Page 29 Operator’s Manual 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 indicator. Two Point O 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.
  • Page 30 ® Infant Flow SiPAP™ Leak Test Have the patient circuit and generator assembled as shown in Fig 3. Connect the patient interface (prong or mask) to the generator (see Chapter 5, Step by Step Fixation) and occlude the opening to the patient. If not powered up already, switch on the power to the driver.
  • Page 31 Operator’s Manual 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.
  • Page 32 ® Infant Flow SiPAP™ Perform the Alarms Test on the Infant Flow® SiPAP™ using the following steps and the initial settings provided above. Make appropriate connections for air and O gas supply. Connect power cord to appropriate AC outlet. Attach patient circuit, generator and patient interface (mask or prong) as shown in Figure 3.
  • Page 33 Operator’s Manual ® Infant Flow SiPAP™ User Verification Test Checklist Driver Serial Number:_____________________ Test Date:_________________ TEST PASS FAIL Automated Tests Power On Check Manual Tests Two Point O Sensor Calibration Patient Circuit Leak test Manual Alarms Checks Low Airway Pressure Alarm High Airway Pressure Alarm High O Alarm...
  • Page 34 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 35: Chapter 5 - Operation

    Operator’s Manual 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 %O blender control.

  • Page 36: Figure 7 - Rear Panel

    ® Infant Flow SiPAP™ Rear Panel Figure 7 – Rear Panel 675-101-101 Revision H...

  • Page 37: Table 2 - Soft-Key Operation

    Operator’s Manual 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 pending confirmation is visually highlighted and intermittently flashes between yellow and white text.
  • Page 38 ® Infant Flow SiPAP™ 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.

  • Page 39: Figure 8 - Set Up Screen

    Operator’s Manual Table 3 – Parameter Default Value Mode NCPAP NCPAP + rate BiPhasic BiPhasic + rate BiPhasic tr monitoring monitoring Parameter T-High Default for NCPAP apply Default for BiPhasic apply Default for BiPhasic tr Rate Default for BiPhasic apply Default for BiPhasic tr This setting applies to all modes: system-wide default applies to all modes...

  • Page 40: Figure 9 - Alarm Set/Confirm Screen

    ® Infant Flow SiPAP™ 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”.

  • Page 41: Figure 10 - Mode Select Screen

    Operator’s Manual Figure 10 – Mode Select Screen 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.

  • Page 42: Figure 12 - Main Screen

    ® Infant Flow SiPAP™ Figure 12 – Main Screen 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.
  • Page 43 Do not attach Generator to the patient until User Verification and initial set up into NCPAP mode is complete. Patient Interfaces from Cardinal Health accommodate a wide range of patients. Application of an incorrectly sized prong, mask or bonnet will affect stability of the generator.
  • Page 44 Please refer to P/N 36-5569 included in the AirLife Infant nCPAP Fixation Device for the Directions for Use. WARNING! Cardinal Health consumables are specifically designed to be used with Infant ® ® Flow Drivers and are the only consumables validated for use with Infant Flow devices.

  • Page 45: Chapter 6 - Operating Modes

    Operator’s Manual 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).
  • Page 46 ® Infant Flow SiPAP™ 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.

  • Page 47: Chapter 7 - Alarms And Indicators

    Operator’s Manual 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.
  • Page 48 ® Infant Flow SiPAP™ 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.

  • Page 49: Figure 17 - Flat Battery Screen

    Operator’s Manual 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.

  • Page 50: Table 4 - Alarm Symbols And Indicators

    ® Infant Flow SiPAP™ Alarm Symbols and Indicators The following displays are shown 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 4 – Alarm Symbols and Indicators Indicator Meaning Battery status/charge level;...
  • Page 51 Operator’s Manual 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;...
  • Page 52 ® Infant Flow SiPAP™ 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.

  • Page 53: Chapter 8 - Maintenance & Cleaning

    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 Cardinal Health 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.
  • Page 54 ® Infant Flow SiPAP™ 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 battery (refer to the Service Manual or your Service Technician).

  • Page 55: Chapter 9 - Explanation Of Symbols

    Symbol #5007 IEC 60417 Indicates ON (Power) Symbol #01-01 IEC 60878 Symbol #5008 IEC 60417 Indicates OFF (Power) Symbol #01-02 IEC 60878 MDD Directive CE Mark 93/42/EEC Cardinal Health This symbol indicates an INTERNAL BATTERY FUSE Symbol 675-101-101 Revision H...
  • Page 56 ISO 15223:2000 (3.11) Operating temperature range of unit EN 980:2003 (5.7.3) 2.5A/T 250 V Fuse holder and fuse rating 101010 Transducer Assembly Cardinal Health Symbol XDCR IEC 60878:1988 Warning Bell (01-41) ISO 7000:2004 (2301) Type BF patient applied part IEC 60878:1988...

  • Page 57: Table 6 - Button Symbols

    Operator’s Manual Source / Meaning Symbol Compliance Keep Dry ISO 15223:2000 (3.8) Keep Away from Heat ISO 15223:2000 (3.8) Symbols used on buttons The following symbols are used to label user input areas within the graphical display. As needed displays in this table are shown separately as Domestic US configuration displays (left-hand column) and non-US configuration displays (right-hand column).
  • Page 58 ® Infant Flow SiPAP™ 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.
  • Page 59 Operator’s Manual Note Provision of labeling in this manual for any function should not be taken as evidence that the function is available. For example parameter R relates to BiPhasic tr* mode, not currently approved for use in the US. 675-101-101 Revision H...
  • Page 60 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 61: Appendix A - Product Configurations

    Operator’s Manual Appendix A - Product Configurations Non-US Configuration Parameters Table 7 – Non-US Configuration Parameters Parameter Accuracy Units Default ±3 Set Oxygen concentration, %O ±15% NCPAP / Pres Low flow rate L/min ± 15% Pres High flow rate L/min ±...
  • Page 62 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 63: Appendix B - Pneumatic Diagram

    Operator’s Manual Appendix B - Pneumatic Diagram 675-101-101 Revision H...
  • Page 64 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 65: Appendix C - Alarm Troubleshooting

    Operator’s Manual Appendix C - Alarm Troubleshooting Table 9 – Alarm Troubleshooting Alarm Priority Possible Cause Actions • O • Restore FiO < 18% High calibration level to above the required. minimum limit • Press Alarm Reset for 3 seconds. •...

  • Page 66: Figure 14 - Ncpap

    ® Infant Flow SiPAP™ Alarm Priority Possible Cause Actions • Battery • Push Alarm Mute button for 3 Battery fault High (Cannot be reset) disconnected seconds to silence alarm • Battery failing to • Refer to Service Engineer. hold charge •...
  • Page 67 Operator’s Manual Alarm Priority Possible Cause Actions • Rr = 0 for > low • Push Alarm Mute button once to Low breath High rate • Plus: audible / breath (apnea) silence alarm interval timeout • Restore patient breathing. visual alarms only •...
  • Page 68 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 69: Appendix D - Fault Management

    Operator’s Manual 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).

  • Page 70: Table 11 - Fault Recovery

    ® Infant Flow SiPAP™ Control Modes and Measurements Features Impact On Unit Reporting Functionality Mechanism Software restarts, Spurious and status bar software Spurious extended mode exception (minor) alternates with trapped worst error code High-priority alarm; status bar Non-fatal error Spurious extended mode trapped (minor)
  • Page 71 Operator’s Manual Clas- Software Corrective Fault condition Consequence sification Response Action Required Unable to User lockout: Non-volatile retrieve/set unit Service: Fix or Unusable Error "E##" memory fault configuration and replace PCB prompt calibration data Service: Low User lockout: Calibration data Sensor readings level calibration Unusable...
  • Page 72 ® Infant Flow SiPAP™ Clas- Software Corrective Fault condition Consequence sification Response Action Required Oxygen sensor High priority Oxygen sensor No oxygen Service: Fix fault (ADC hits alarm; Error readings invalid monitor sensor/circuits. rail) "E##" prompt Oxygen sensor User: Check gas Possible fuel cell, can not be High priority...
  • Page 73 Operator’s Manual Clas- Software Corrective Fault condition Consequence sification Response Action Required Spurious Hardware software reinitialized Software interrupt, XTAL (disabled) with Software: Fix interrupted and fails, stack Spurious alarm bar lit and persistent restarts (possibly overflow/underflo beeper sounding exceptions during treatment) w, CPU Class B to identify root exception...
  • Page 74 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 75: Glossary

    Operator’s Manual Glossary Term Meaning Apnea Temporary inability to breathe. Low Breath Rate Breaths per minute (applies to each of spontaneous, triggered and mandatory) CPAP Continuous Positive Airway Pressure Patient attachment for delivering CPAP, used with nasal prongs or Generator mask Time triggered, time cycled pressure assists at two separate pressures BiPhasic...
  • Page 76 ® Infant Flow SiPAP™ ® Infant Flow SiPAP™ 675-101-101 Revision H...

  • Page 77: Index

    Operator’s Manual Index features, 1 fixation, 31 Flat Battery alarm, 37 Absominal Respiratory Sensor, 14 front panel, 23 Accessories, 2 Fully integrated alarm package, 1 airway pressure, 15 alarm priority, 35 Alarm set/confirm Screen, 28 Alarm Symbols, 38 gas flow, 15 alarms, 4 Alarms, 35 Alarms Test, 19...
  • Page 78 ® Infant Flow SiPAP™ silence active alarms, 35 Silencer / Bacterial Filter, 5 Parameter Adjust Screen, 29 Soft-key operation, 25 parameter default values, 26 specifications, 3 ® Patented Infant Flow Generator, 1 Storage, 42 patient circuit, 13 Supply Gases Failure alarm, 36 physical specifications, 5 symbols, 43 Pneumatic Diagram, 51...

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