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The Cardinal AirLife nCPAP System 6900, released in 2006 by Cardinal Health, helps infants breathe easier and develop healthier lungs. Driver Model: 006900.

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[flag|biomed]

== Background and Identification ==

Located in Dublin, Ohio, Cardinal Health, Inc. is a global company serving the health-care industry with a wide range of products. Cardinal Health products can be found in most hospitals across the US.

The AirLife® nCPAP System Driver provides continuous positive airway pressure (CPAP) for use in hospitals to treat spontaneously breathing newborns and infants with Respiratory Distress Syndrome (RDS). The driver operates on hospital or tank air, and oxygen. The system driver incorporates an electronic blender using solenoid valves and servo-controlled flow to maintain a user-set pressure and FiO2. The system also utilizes a durable oxygen sensor. The user interface displays oxygen concentration, CPAP level, flow rate, trending, and power and alarm conditions. The oxygen sensor automatically calibrates every time the instrument is turned on. The driver is part of a larger system that includes an nCPAP generator, fixation device, and patient interface (prongs and/or masks).

The machine features a large, high-contrast LCD screen that provides vital operating information such as pressure, flow, FIO2 and battery life. It also utilizes an internal rechargeable battery that allows the system to operate up to four hours on a charge. The device is essentially portable with its four hour charge, 15 pound weight, and compact dimensions of 8 ½ x 8 ½ x 6 ½ inches, however, it is not cleared to be used in ambulances or airplanes.

The system driver has been recalled by the FDA twice, both in 2007 and 2008.  In 2007, it was reported  under isolated conditions, the device may experience issues with O2 calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.  Whereas in 2008 it was reported that there were significant oxygen fluctuations occurring.  The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min. For more information regarding these recalls visit the links to the FDA reports at the bottom of the page.

== Technical Specifications ==

***Weight:*** Approx. 15 pounds

***Dimensions:*** 8 ½ x 8 ½ x 6 ½ inches (excluding gas inlets, patient outlets, and mounting brackets)

***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 cmH2O Monitor Range: 1–11 cmH2O, accuracy ±1 cmH2O. Pressure is displayed as <1 or >11 when outside this range.

 ***Oxygen Control / Monitor Control/Display Range:*** 21%–100% O2, accuracy ±3 percentage points Monitor Range: 17%–104%O2, accuracy ±3 percentage points

 ***Sensor Type:*** Long Life Ultrasonic (5+ years)

 ***Flow Monitoring Range:*** 0–15 LPM, accuracy ±10%

***Power Supply:*** 15 V DC, 3.3 A from included AC adapter (GlobTek, Inc. Model number GTM21097-5015) or an internal 12 V sealed lead/acid battery. The battery has a life of four (4) hours from a full charge (up to 16 hours required for recharge).

***Pressure Relief:*** (2 systems) Automatic electronic valve system preset to vent to ambient air when a High Pressure alarm occurs  Mechanical internal relief valve preset to vent at 3 ±0.15 psig (211 ±11 cmH2O)

***Flow Limit:*** Electronic flow limit to prevent the delivery flow from exceeding 3 LPM over Target Flow or 15 LPM.

***Alarm System:*** 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.

·         Supply Gas Pressure Alarm

·         High Pressure Alarm

·         Elevated Pressure Alarm

·         Low Pressure Alarm

·         Disconnect Alarm

·         Leak Alarm

·         Low Flow Alarm

·         Oxygen Concentration Alarms

·         Battery Alarms

·         Oxygen Calibration Alarm

·         Software Fault

·         Flow / Pressure Sensor

***IEC 60601-1 Classification:*** Internally Powered Equipment, Type BF, IPX 1 This equipment is rated for Continuous Operation.

== Additional Information ==

[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52879|2007 FDA System Driver Recal]l

[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67152|2008 FDA System Driver Recall]

[https://cardinalhealth.mediaroom.com/newsreleasearchive?item=122436|Cardinal Health Press Release]

[https://cardinalhealth.mediaroom.com/index.php|Cardinal Health Website]

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Cardinal AirLife nCPAP System 6900 Operations Manual.pdf

Cardinal AirLife nCPAP System 6900 Hardware Service Manual.pdf

Tsonga

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