Air Life ® 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

Table of Contents

Table Caption: This table of contents outlines the specifications, operational instructions, maintenance procedures, and supplementary information for a product, likely a medical device given the inclusion of IEC 60601-1 classification and sections on gas supply and oxygen control. It details product features, setup, usage scenarios, troubleshooting, and appendices covering accessories, electromagnetic compatibility, and warranty.

Product Description

The Air Life ® 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). The driver operates on hospital or tank air, and oxygen. The device has an internal battery and can be used for intra-hospital transport, but is not intended for use in ambulances or aircraft.

The Air Life ® nCPAP 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 long-life 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 powered on. The driver is part of a larger system that includes an nCPAP generator, fixation device, and patient interface (prongs and/or masks).

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 cmH2O <1 or >11 when outside this range.

Monitor Range: 1-11 cmH2O, accuracy ±1 cmH2O. Pressure is displayed as

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).

Weight

Approx. 15 pounds

Dimensions

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

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

Electroni