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Summary of Contents for Cardinal Health AirLife 006900
- Page 1 ® AirLife nCPAP System Operator’s & Routine Maintenance Manual Driver Model 006900 Firmware Version 2.02 Latex Free Cardinal Health McGaw Park, IL 60085 USA 36-5031 Rev D Distributed in Canada by Source Medical Corporation Mississauga, Ontario L4Z 4B9...
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Page 3: Table Of Contents
Table of Contents Product Description...............2 Product Specification ............3 Gas Supply ...................... 3 Pressure Control / Monitoring ................3 Oxygen Control / Monitor................. 3 Flow Monitoring ....................3 Power Supply ....................3 Weight ......................3 Dimensions...................... 3 Pressure Relief ....................3 Flow Limit ...................... -
Page 4: Product Description
Product Description ® The AirLife nCPAP System Driver is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat spontaneously breathing newborns and infants with Respiratory Distress Syndrome (RDS), or are recovering from RDS under the supervision of qualified personnel (e.g., respiratory therapist or nurse). -
Page 5: Product Specification
Product Specification Gas Supply 41–66 psig (nominal 50 psig) clean, dry, medical air and oxygen. External pressure regulators should be used if source pressures exceed 66 psig. Pressure Control / Monitoring Control Range: 2–10 cmH Monitor Range: 1–11 cmH O, accuracy ±1 cmH O. - Page 6 Supply Gas Pressure Alarm: An audible and visual Source Pressure alarm will activate if the inlet pressure of one, or both, of the gas sources are outside of the specified gas supply range. There is a 1 second delay for this alarm.
- Page 7 Disconnect Alarm: An audible and visual ‘Disconnect’ alarm is preset to detect a pressure line or patient interface that has come loose or that is disconnected. The alarm is set to activate according to the following list: Flow (LPM) CPAP (cmH ≥...
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Page 8: Iec 60601-1 Classification
Oxygen Calibration Alarm: An audible and visual Oxygen Calibration alarm will indicate if an oxygen sensor has failed to calibrate. If this alarm occurs, remove patient and cycle the power for re-calibration or remove the driver from service. While the alarm is active, the driver provides CPAP and , however, the FiO may not be accurate. -
Page 9: Driver Feature Diagram - Front Panel
Driver Feature Diagrams Figure 1: Front Panel Features Item Description Pressure LED Bar Graph (Indicates instantaneous patient pressure) Pressure Display (Indicates average patient pressure) Message Bar Display Alarm Priority LEDs and Alarm Mute Alarm Mute/Reset Button (Press & Release for Mute/Reset; Press & Hold for Standby Mode) Power Status Interface Control Knob Trend Selection... -
Page 10: Driver Feature Diagram - Back Panel
1 2 3 Figure 2: Back Panel Features Item Description Power Connection Fuse Power Switch (Switch does not disconnect driver from main power supply) Oxygen Inlet Water Trap and Air Filter (behind Air Inlet; not visible in this view) Medical Air Inlet Nationally Recognized Testing Laboratory (NRTL) Classification Serial Number ®... -
Page 11: Warnings And Cautions Summary
Warnings and Cautions Summary ® The AirLife nCPAP System Driver is intended to be operated only by qualified personnel under the direction of a physician. The operator is responsible for reading and thoroughly understanding the provided product documentation. Definitions to be considered throughout the document: Warning: Used when the operator or the patient have the possibility of being injured. - Page 12 Warning: There is always a risk when using oxygen that the O level in the arterial plasma will reach an unacceptable level. This driver should always be used in conjunction with a pulse oximeter to monitor patient status. Oxygen toxicity can be a concern with this device for the intended population if it is used for more than a few hours.
- Page 13 Caution: The driver will be damaged if any part of it is immersed in liquid or gas, or steam sterilized. Note: Alarms are delayed for 120 seconds after entering the main screen in order to allow time for patient setup. If the patient setup takes longer than 120 seconds, the alarms can be muted for an additional 120 seconds by pressing the alarm mute/reset button or the system can be placed into Standby Mode.
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Page 14: Operating Instructions
Operating Instructions ® The AirLife nCPAP System is designed to provide an airway pressure that ® is practically constant. The AirLife generator utilizes vortice technology to help reduce the patient’s imposed Work of Breathing. The Driver automatically adjusts the gas flow rate to deliver the set CPAP level and compensate for minor leaks in the system. - Page 15 Note: To enhance patient safety and comfort, use only with heated humidifiers and heated wire circuits. The recommended delivery is 37 °C, 100% RH. Visually inspect the inlet air filter and water trap, located on the back of the driver. See Figure 4. If the filter is dirty or wet, it must be cleaned or replaced.
- Page 16 Medical Air Oxygen Inlet Inlet Figure 5: Air and Oxygen Connectors on Driver • Plug the external power source into the power connector on the back of the driver and an AC outlet. See Figure 6. Power Connector Figure 6: AC Power Connector on Driver Warning: When driver is connected to power source, keep cords clear of walkways to avoid possible cord entanglement and strangulation.
- Page 17 Figure 7: Illuminated LEDs Note: Class 1 LED product. Verify that the following default values are indicated on the main screen: • CPAP Set: 5 cmH • Set: 21% O • Flow Rate Target: 8 LPM • Battery charging (lightning bolt in battery icon) Note: Alarms are delayed for 120 seconds after entering the main screen in order to allow time for patient setup.
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Page 18: Interface Control Knob Operation
Interaction with Display Settings ® Control of the various AirLife nCPAP Driver features is accomplished through the use of the Interface Control Knob. Figure 9: Interface Control Knob Interface Control Knob Operation To adjust the %O , CPAP, or Flow Target values, follow these steps. Rotate the knob to move the highlight cursor to the different sections of the screen. -
Page 19: Standby Mode
Figure 11: Parameter Change Screen When the desired value is displayed in the Message Bar, press the knob and release to activate the new set value. The value will set only on the release, not the press, of the knob. The change will automatically be canceled after ten (10) seconds of inactivity and the previous setting will remain unchanged. -
Page 20: Air Or Oxygen Only Mode
Mute/Reset button or the system will automatically exit the mode and resume normal operation after 20 minutes. While in Standby Mode the system will operate normally with all audible alarms muted, with the exception of High Pressure and Low Flow. To indicate that the system is in Standby Mode, the Message Bar will display “Standby Mode”... - Page 21 Figure 12: Trending Display on Screen To access the Trend screen: Rotate the interface control knob until the ‘Trend’ feature is highlighted. Press and release the knob to activate the Trend screen. Rotate the knob to select the desired Trending time: 4, 8, 12, or 24 hours.
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Page 22: System Operaton
System Operation Follow manufacturer's recommended instructions when setting up a patient with the fixation device, generator and patient interface. Once the patient has been properly set-up, set the prescribed values for the CPAP level and FiO . Connect the pressure line and the drive line of the circuit to the driver. -
Page 23: Final Checks And Routine Inspection
Warning: Use this product only as directed in the product literature to reduce the possibility of nasal and skin irritation, and necrosis. Warning: There is always a risk when using oxygen that the O level in the arterial plasma will reach an unacceptable level. -
Page 24: Icon Legend
12. If running in battery mode, ensure that the battery is sufficiently charged. Icon Legend Figure 14, below, describes the meanings of the different icons that may appear on the driver display. Figure 14: Icon Legend ® AirLife nCPAP Operator’s Manual... -
Page 25: Alarm Details And Actions
Alarm Details and Actions Alarm Priority Indication Suggested Action Elevated Pressure Medium • Audible alarm • Check the exhaust tube (2cm H O over Set • Yellow flashing LED for occlusions or Value) • Message Bar restrictions Low Pressure Medium •... - Page 26 Alarm Priority Indication Suggested Action Leak Medium • Audible alarm • Check for leaks or (3 LPM over the • Yellow flashing LED disconnections in the Target Flow rate • Message Bar tubes and circuit, or in the or a Flow Rate nasal prongs and mask of >15 LPM) •...
- Page 27 Alarm Priority Indication Suggested Action Air Pressure Low High • Audible alarm • Correct air supply • Red Flashing LED pressure • Message Bar • Select ‘Oxygen Only’ mode • Follow on-screen directions Air Pressure High High • Audible alarm •...
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Page 28: Cleaning And Routine Maintenance
Cleaning and Routine Maintenance Routine maintenance and cleaning should be performed every six (6) months or if a driver fails the Driver Setup procedure. However, maintenance can be performed as often as desired. A unit that fails must be removed from service for a complete service or calibration inspection. - Page 29 Unplug the external power source, verify a single audible alarm burst sounds and the interface indicates the driver is operating on battery power. Indication on the display includes the green LED and Plug icon ceasing to illuminate and bars appearing in the battery to indicate the level of available battery life.
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Page 30: Disposal
Disposal Patient accessories, including the generator, fixation device, prongs, masks, breathing circuit, and humidification chamber, should be disposed of by incineration in order to reduce the risk of contamination. Warning: The patient accessories for use with the AirLife® nCPAP Driver are for single patient use only. Disposable accessories include generators, fixation device, prongs, masks, heated wire breathing circuits, and humidification chambers. -
Page 31: Appendix A: Approved Accessories
Appendix A: Approved Accessories Component Company Catalog Numbers Disposable Accessories Cardinal Health RC51-12002 EME/Viasys CC8112E Delivery Circuit Hamilton 33078 Fisher and Paykel RT132 Cardinal Health 006905 Generator Set (Nasal Prongs are included EME/Viasys D350T/R, D350T with the Generator Set) Hamilton... -
Page 32: Appendix B: Electromagnetic Compatibility
Appendix B: Electromagnetic Compatibility The following information is directed by the Standard IEC 60601-1-2:2001 for Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. ® Warning: The use of any power cords with the AirLife nCPAP System Driver other than those supplied with the driver may result in increased emissions and/or decreased ®... - Page 33 Table 3: Guidance and Manufacturer's Declaration—Electromagnetic Immunity ® The AirLife nCPAP System Driver is intended for use in the electromagnetic environment ® specified below. The customer or user of the AirLife nCPAP System Driver should assure that it is used in such an environment. IEC 60601-1-2 Compliance Electromagnetic...
- Page 34 Table 4: Guidance and Manufacturer's Declaration—Electromagnetic Immunity ® The AirLife nCPAP System Driver is intended for use in the electromagnetic environment ® specified below. The customer or user of the AirLife nCPAP System Driver should assure that it is used in such an environment. IEC 60601-1-2 Compliance Electromagnetic Environment—...
- Page 35 NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
- Page 36 Table 5: Recommended separation distances between portable and mobile RF ® communications equipment and the AirLife nCPAP System Driver ® The AirLife nCPAP System Driver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. ®...
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Page 37: Appendix C: Warranty Information
Cardinal Health will not accept any liability for any injury or damage to persons or property resulting from a breach of these conditions.
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