Cardinal Health AirLife nCPAP User manual

AirLife®nCPAP System
Hardware Service Manual
Driver Model 006900
Firmware Version 2.02
Cardinal Health
McGaw Park, I 60085 USA
Distributed in Canada by
Source Medical Corporation
Mississauga, Ontario T5 1C2
36-5777

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 2 of 81
Table of Contents
1. PRODUCT DESCRIPTION ............................................................................................................................4
2. PRODUCT SPECIFICATIONS.......................................................................................................................5
2.1 MODES OF OPERATION ...............................................................................................................................................5
2.2 PNEUMATIC SUPPLY ...................................................................................................................................................5
2.3 CPAP PRESSURE CONTROL /MONITORING ................................................................................................................5
2.4 OXYGEN CONTROL /MONITOR...................................................................................................................................5
2.5 FLOW MONITORING....................................................................................................................................................5
2.6 POWER SUPPLY...........................................................................................................................................................6
2.7 CONNECTIONS FOR ACCESSORIES...............................................................................................................................6
2.8 WEIGHT ......................................................................................................................................................................6
2.9 DIMENSIONS ...............................................................................................................................................................6
2.10 PRESSURE RELIEF .......................................................................................................................................................7
2.11 FLOW LIMIT................................................................................................................................................................7
2.12 IEC 60601-1 CLASSIFICATION....................................................................................................................................7
2.13 STORAGE AND OPERATING CONDITIONS ....................................................................................................................7
3. DRIVER FEATURE DIAGRAMS ...................................................................................................................8
FIGURE 1: FRONT PANEL FEATURES........................................................................................................................................8
FIGURE 2: REAR PANEL FEATURES..........................................................................................................................................9
FIGURE 3: UNDERSIDE FEATURES............................................................................................................................................9
FIGURE 4: SPLASH SCREEN....................................................................................................................................................10
FIGURE 5: ICON LEGEND .......................................................................................................................................................10
4. ALARM SYSTEM .........................................................................................................................................11
4.1 NON-LATCHING AND LATCHING ALARM SIGNALS ...................................................................................................11
4.2 ALARM SITUATIONS .................................................................................................................................................11
4.2.1 Supply Gas Pressure Alarm .............................................................................................................11
4.2.2 High Pressure Alarm.........................................................................................................................11
4.2.3 Elevated Pressure Alarm ..................................................................................................................12
4.2.4 Low Pressure Alarm .........................................................................................................................12
4.2.5 Disconnect Alarm..............................................................................................................................12
4.2.6 Leak Alarm........................................................................................................................................12
4.2.7 Low Flow Alarm ................................................................................................................................12
4.2.8 Oxygen Concentration Alarms..........................................................................................................13
4.2.9 Battery Alarms ..................................................................................................................................13
4.2.10 Oxygen Calibration Alarm.................................................................................................................13
4.2.11 Software Fault...................................................................................................................................13
4.2.12 Flow/Pressure Sensor ......................................................................................................................13
5. WARNINGS AND CAUTIONS SUMMARY .................................................................................................14
6. APPROVED ACCESSORIES LIST .............................................................................................................20
7. DRIVER SET-UP, OPERATION, AND BASIC INSPECTION .....................................................................21
7.1 MOUNTING BRACKET AND CLAMP ASSEMBLY .........................................................................................................21
7.2 ATTACH DRIVER TO STAND......................................................................................................................................21
7.3 INSPECT AIR FILTER .................................................................................................................................................22
7.4 CONNECT HOSES &POWER ......................................................................................................................................22
7.5 INTERACTION WITH DISPLAY SETTINGS....................................................................................................................23
7.5.1 Control Knob Operation ....................................................................................................................23
7.5.2 Standby Mode...................................................................................................................................24
7.5.3 Air or Oxygen Only Mode .................................................................................................................24
7.5.4 Trending............................................................................................................................................25
7.5.5 System Operation .............................................................................................................................25

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 3 of 81
8. ROUTINE CLEANING & SET-UP................................................................................................................26
8.1 BATTERY ..................................................................................................................................................................26
8.2 UNIT INSPECTION AND CLEANING ............................................................................................................................27
8.3 DISPOSAL .................................................................................................................................................................28
9. DRIVER MAINTENANCE SCHEDULE........................................................................................................29
10. RECOMMENDED TOOLS AND TORQUE SPECIFICATIONS...................................................................30
11. PREVENTIVE MAINTENANCE– EXTERNALLY ACCESSIBLE................................................................31
11.1 MOUNTING BRACKET AND CLAMP ASSEMBLY .........................................................................................................32
11.2 AIR FILTRATION MAINTENANCE ..............................................................................................................................33
11.3 AIR AND OXYGEN INLET SCREEN REPLACEMENT.....................................................................................................34
11.4 OXYGEN BLEED FLOW MEASUREMENT....................................................................................................................35
11.5 FUSE REPLACEMENT.................................................................................................................................................35
12. PREVENTIVE MAINTENANCE– INTERNALLY ACCESSIBLE.................................................................36
12.1 REMOVE THE TOP CASE FROM THE BOTTOM CASE...................................................................................................37
12.2 REPLACE THE OXYGEN SENSOR FILTERS..................................................................................................................38
12.3 REMOVE THE FRONT PANEL ASSEMBLY ...................................................................................................................39
12.4 REMOVE THE BATTERY ASSEMBLY ..........................................................................................................................41
12.5 REMOVE THE MANIFOLD ASSEMBLY........................................................................................................................43
12.6 REMOVE THE DIVIDER/OXYGEN SENSOR ASSEMBLY ...............................................................................................45
12.7 REMOVE THE OUTLET FITTING ASSEMBLY...............................................................................................................47
12.8 REMOVE THE CONTROL KNOB/SELECTOR SWITCH...................................................................................................48
12.9 REPLACE THE MAIN BOARD (PCA-01)/ CONTRAST ADJUSTMENT ...........................................................................49
12.10 REPLACE THE BOTTOM CASE ...................................................................................................................................51
13. REASSEMBLING THE NCPAP DRIVER ....................................................................................................52
13.1 ASSEMBLE THE CONTROL KNOB/SELECTOR SWITCH ...............................................................................................52
13.2 INSTALL THE OXYGEN BLEED FITTING .....................................................................................................................52
13.3 INSTALL BATTERY ASSEMBLY .................................................................................................................................52
13.4 INSTALL THE OUTLET FITTING ASSEMBLY ...............................................................................................................53
13.5 INSTALL THE DIVIDER/OXYGEN SENSOR ASSEMBLY................................................................................................54
13.6 INSTALL THE MANIFOLD ASSEMBLY ........................................................................................................................55
13.7 INSTALL POWER CABLE ASSEMBLY .........................................................................................................................57
13.8 INSTALL THE FRONT PANEL ASSEMBLY ...................................................................................................................58
13.9 INSTALL THE TOP CASE ............................................................................................................................................60
13.10 CHARGING THE BATTERY AFTER MAINTENANCE .....................................................................................................61
13.11 DISPOSAL RECOMMENDATIONS ................................................................................................................................61
14 COMPREHENSIVE PERFORMANCE TEST...............................................................................................62
14.1 COMPREHENSIVE PERFORMANCE TEST.....................................................................................................................62
14.2 PERFORMANCE TEST DATA SHEET ...........................................................................................................................68
15. TROUBLESHOOTING .................................................................................................................................70
15.1 Alarm Details and Actions .......................................................................................................................70
15.2 Warning Screens .....................................................................................................................................72
16. PNEUMATIC DIAGRAM ..............................................................................................................................76
18. MRI NOTICE.................................................................................................................................................80
19. WARRANTY INFORMATION ......................................................................................................................81
DISCLAIMER .............................................................................................................................................................81
20. TECHNICAL SERVICE……………………………………………………………………………...………………81

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 4 of 81
M
MM
M AINTENANCE
AINTENANCE AINTENANCE
AINTENANCE &
&&
& R
RR
R EPAIR
EPAIREPAIR
EPAIR
This manual includes procedures used when repairing or replacing parts and components of the
AirLife®nCPAP System Driver, Catalog Number 006900, not covered by warranty and is intended
for use by a competent, fully qualified Service Engineer or Technician.
Note:
Always disconnect the machine from facility power, oxygen and
medical air before performing any maintenance procedures.
1. PRODUCT DESCRIPTION
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), or those recovering from RDS under the supervision of qualified personnel
(e.g., respiratory therapist or nurse). The driver operates on medical grade 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 AirLife®nCPAP System Driver incorporates an electronic gas blender using solenoid valves
and servo-controlled flow to maintain a user-set CPAP pressure and FiO2. The user interface
displays oxygen concentration, CPAP level, flow rate, trending, power, and alarm conditions. The
device utilizes both audible and visual indicators for alarm conditions, including text on the LCD
display to help the clinician interpret and correct alarm conditions.
The AirLife®nCPAP System Driver utilizes a long-life ultrasonic oxygen sensor and automatically
performs a two-point oxygen sensor calibration each time the instrument is powered on. The
device automatically performs routine Oxygen Sensor Drift Checks/Calibrations during operation
at 20 minutes, 40 minutes, and every 12 hours thereafter after power up.
The device requires both medical air and oxygen in order to pass the Power-On Self Test and
enter Patient Treatment Mode (the main screen). Due to the nature of the electronic pressure
control and gas blending, the device only delivers gas while it is powered on. When turned off, no
gas flow exits the Patient Circuit Connection or Oxygen Sensor Bleed Port.
The AirLife®nCPAP System Driver is part of a larger system that includes an nCPAP generator,
fixation device, and patient interface (prongs and/or masks). This system has been designed and
tested with Approved Accessories (see Table of Contents) and will perform optimally when used
with accessories provided by Cardinal Health, Inc.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician
or licensed practitioner.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 5 of 81
2. PRODUCT SPECIFICATIONS
2.1 Modes of Operation
Non-Invasive nasal Continuous Positive Airway Pressure (nCPAP)
2.2 Pneumatic Supply
Required Supply Gases: Clean, dry, medical air and oxygen using standard DISS fittings
regulated between 41 – 66 psig (nominal 50 psig). External pressure regulators must be used
if source pressures exceed 66 psig.
WARNING
Water, excessive water vapor, or debris in the air or oxygen supply gases
may cause the driver to malfunction.
The gas blender and monitoring system are designed for medical grade air
and oxygen only. Do not modify the inlets to accommodate other gas
sources.
2.3 CPAP Pressure Control / Monitoring
Pressure Control Range: 2 – 10 cm H2O
Monitor Range: 1 – 11 cm H2O, accuracy ±1 cm H2O. Pressure is displayed as <1 or >11
when outside this range.
2.4 Oxygen Control / Monitor
Display Range: 21% – 100% O2
Alarm Monitoring Range: 17% – 104% O2
Tolerance ±3% of full scale
Sensor Type: Long Life Ultrasonic
Note:
Driver must be used in combination with external monitoring of patient. Per AARC
Clinical Practice Guidelines for the application of CPAP therapy to neonates,
monitoring includes periodic blood gas value sampling, continuous noninvasive
blood gas values via transcutaneous O2and CO2monitors, continuous noninvasive
SaO2values by pulse oximetry, as well as continuous electrocardiogram and
respiratory rate measures.
2.5 Flow Monitoring
Range: 0 – 15 lpm, accuracy ±10% of Full Scale

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 6 of 81
2.6 Power Supply
Required Power Supply: 15 V DC, 3.3 A, AC adapter (Included, GlobTek, Inc. Model number
GTM21097-5015) or an internal 12 V sealed lead/acid battery (included).
The battery has a working time of four (4) hours from a full charge. Battery charging is active
when the driver is connected to an AC outlet regardless of whether the driver is turned on or
off. The battery requires up to 16 hours of charging to ensure a full charge.
While in operation using battery mode, the battery voltage is monitored and displayed as a
percentage of the 4-hour battery life in increments of 25%. Low battery alarms occur at
approximately 24 minutes of operation remaining (Medium Priority alarm) and at approximately
12 minutes of operation remaining (High Priority alarm).
CAUTION
The correct AC adapter must be used with the driver. Use of an incorrect
AC adapter can damage the internal circuits of the driver.
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 Immunity of the AirLife®nCPAP System Driver.
2.7 Connections for Accessories
Patient Circuit Connection: Standard 15mm Conical/Tapered ID fitting
Proximal Pressure Port: 4.5 mm Luer Compatible ID fitting
2.8 Weight
Approximately 15 pounds
2.9 Dimensions
8-1/2 x 8-1/2 x 6-1/2 inches (excluding gas inlets, patient outlets, and mounting brackets)

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 7 of 81
2.10 Pressure Relief
The Driver is equipped with two pressure relief systems. Both systems are self-resetting if the
high pressure condition is resolved.
Electronic — An automatic vent valve system preset to vent to ambient air when a High
Pressure alarm (patient pressure) occurs.
Mechanical — An internal relief valve is preset to vent if circuit drive pressure exceeds 211
±11 cm H2O (3 ± 5% psig).
2.11 Flow Limit
The Driver includes an electronic flow limit to prevent the delivery flow from exceeding 3 lpm
over Target Flow, or 15 lpm, whichever is lower. The Target flow may be increased by the
operator to compensate for larger leaks. The Driver has a High Priority Low Flow Limit alarm
that activates if the measured flow rate is < 3 lpm.
2.12 IEC 60601-1 Classification
Internally Powered Equipment, Type BF, IPX 1. This equipment is rated for continuous
operation. This equipment is not suitable for use in the presence of flammable anesthetics.
CAUTION
Although this device meets the requirements of current EMC/RFI legislation,
this does not guarantee immunity from all sources of radiated energy. Some
mobile telephones and other products containing radio transmitting
components may cause a malfunction of the device and should not be used in
the vicinity of the device.
2.13 Storage and Operating Conditions
Safe for storage at -20°C to +60°C
Relative humidity of 15% to 95% non-condensing
Atmospheric pressure 0.6 to 1.4 Bar.
Operating environment temperature is +5°C to +40°C
Keep dry and do not expose to direct sunlight
This product meets the EMC requirements of IEC60601-1
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.
DO NOT STERILIZE OR REUSE

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 8 of 81
3. DRIVER FEATURE DIAGRAMS
Figure 1: Front Panel Features
Item Description
1 Protective housing
2 Pressure LED Bar Graph (Indicates instantaneous patient pressure)
3 Pressure Display (Indicates average patient pressure)
4 Message Bar
5 FiO2Display
6 Alarm Priority LEDs (Fault LED on top; Warning LED on bottom)
7 Alarm Mute LEDs
8 Alarm Mute/Reset Button
(Press & Release for Mute/Reset or to clear a latched alarm; Press
& hold for Standby Mode)
9 Power LEDs
10 Power Status
11 Control Knob (Turn to scroll; Push and release to accept)
12 Trend Selection
13 Flow Display
14 Proximal Pressure Port- Standard 4.5mm Luer compatible ID
15 Patient Circuit Connection- Standard 15mm ID, conical
1
2
3 4 5 6
7
10
11
12131415
9
8

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 9 of 81
Figure 2: Rear Panel Features
Figure 3: Underside Features
Item Description
1 Power Connection
2 Fuse (Fast acting; 3.0 Amp; 250 Volt; size: 5 x 20
mm)
3 Power Switch
(Switch does not disconnect driver from main
power supply)
4 Medical Oxygen Inlet
5 Medical Air Inlet
6 Serial Number
7 Nationally Recognized Testing Laboratory (NRTL)
Classification
Item Description
1 Water Trap and Air Filter
2 Oxygen Sensor Bleed Port (do not block)
3 Ventilation / Drainage Holes (do not block)
1 2 3
4
5
7
6
123
(6 places)

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 10 of 81
Figure 4: Splash Screen
(Displayed only at Startup)
Example Screen
Figure 5: Icon Legend

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 11 of 81
4. ALARM SYSTEM
Alarms are delayed for 120 seconds after entering Patient Treatment Mode (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.
WARNING
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.
4.1 Non-Latching and Latching Alarm Signals
If all High Priority alarm conditions return to normal, the audible alarm turns off, the Red Fault
LED switches from flashing to steady lit and the Message Bar continues to display the alarm
condition(s). Pressing the Alarm Mute/Reset button turns off the Red Fault LED and clears the
Message Bar.
If all Medium or Low Priority alarm conditions return to normal, the audible alarm and Yellow
Warning LED clear automatically, and the Message Bar no longer displays the alarm
condition(s) and returns to display “System Active” to indicate normal operation.
4.2 Alarm Situations
The following describes the alarm situations that may occur during operation:
4.2.1 Supply Gas Pressure Alarm
An audible and visual High Priority 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. The
alarm message will indicate the specific gas source that is out of specification. If a single
gas source goes out of range during operation, then only the remaining gas source will be
available (air or oxygen) and FiO2blending will become inoperable. The user will be able to
select either ‘Air Only’ or ‘Oxygen Only’ to allow the unit to operate in single-gas source
mode and mute the FiO2alarms while the problem is corrected. The system will
automatically return to normal operation (blending to the original FiO2setting) when the
problem is corrected and the source pressures are returned to within the specified range.
There is a 1-second delay for this alarm.
4.2.2 High Pressure Alarm
An audible and visual High Priority High Pressure alarm has dual limits. The first limit will
activate the alarm when the monitored pressure is greater than or equal to 12 cm H2O for
two (2) seconds. The second limit will activate the alarm immediately when the monitored
pressure is greater than or equal to 18 cm H2O. This alarm automatically activates the
electronic pressure relief solenoid and closes the patient delivery solenoid, which instantly
reduces the pressure in the patient circuit to zero. Approximately every three (3) seconds,
the system will reinstate flow. If the alarm condition has cleared, the unit will operate

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 12 of 81
normally. If the alarm condition still exists, the ‘High Pressure’ alarm will cycle through the
3-second loop.
4.2.3 Elevated Pressure Alarm
An audible and visual Medium Priority Elevated Pressure alarm is preset for a CPAP
pressure that is 2 cm H2O above the Set CPAP level. There is a 5-second delay for this
alarm.
4.2.4 Low Pressure Alarm
An audible and visual Medium Priority Low Pressure alarm is preset for a CPAP pressure
that is 2 cm H2O below the Set CPAP level. There is a 14-second delay for this alarm.
4.2.5 Disconnect Alarm
An audible and visual Medium Priority 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
when both conditions are met according to the following chart:
Measured
Flow
(lpm)
Measured
CPAP
(cm H2O)
≥0
≤1
≥6
≤2
≥9
≤3
≥12
≤4
≥14
≤5
While the alarm is active, the patient flow will remain within ±2 lpm of Target Flow. There is
a 5-second delay for this alarm.
For example: if the measured flow rate is ≥6 lpm AND the CPAP Level is ≤2 cm H2O for a
period of five (5) seconds, a Medium Priority alarm will activate.
4.2.6 Leak Alarm
An audible and visual Medium Priority Leak alarm is preset for a flow rate that is 3 lpm
above the Target Flow rate or for a flow that is greater than 15 lpm. There is a 5-second
delay for this alarm.
4.2.7 Low Flow Alarm
An audible and visual High Priority Low Flow alarm is preset for flow rates at or below 3
lpm. There is a 10-second delay for this alarm.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 13 of 81
4.2.8 Oxygen Concentration Alarms
The oxygen concentration is allowed to operate within a ±3 %O2 range without alarming.
A Medium Priority alarm will activate whenever the product of the variance outside of the
FiO2 range and the duration (in seconds) of the variance exceeds 20.
A High Priority alarm will activate whenever the product of the variance outside of the FiO2
range and the duration (in seconds) of the variance exceeds 30.
For example: if the Set %O2 is 30% and the reading is 35% for a period of ten (10)
seconds, a Medium Priority alarm will activate. In this case the reading is 2 percentage
points outside of the ±3 percentage point range. If the Set %O2 is 30% and the reading is
35% for a period of 15 seconds, a High Priority alarm will activate.
4.2.9 Battery Alarms
An audible and visual Low Battery alarm has dual limits. The first limit will activate the
Medium Priority alarm when the battery falls below 10% remaining (approx. 24 minutes of
battery power remaining). The second limit will activate the High Priority alarm when the
battery falls below 5% remaining (approx. 12 minutes of battery power remaining). There is
a 2-second delay for this alarm. An audible and visual Battery Charge Fail alarm will
indicate if the battery is not charging properly. The system verifies proper charging at start
up and routinely during operation. There is a 5-second delay for this alarm.
4.2.10 Oxygen Calibration Alarm
An audible and visual High Priority Oxygen Calibration alarm will indicate if an error occurs
during the Oxygen Sensor calibration. A Warning Screen will appear indicating that an
error occurred during the Oxygen Sensor Calibration and informing the user to either
remove the patient from the device and cycle power or remove the device from service.
While the alarm is active, the driver provides CPAP and FiO2; however, the FiO2 may not
be accurate. The system calibrates the Oxygen Sensor during the Power-On Self Test and
routinely during operation. There is no delay for this alarm.
4.2.11 Software Fault
An audible and visual High Priority Software Fault alarm will indicate if a software fault is
detected. The system will display a fault code, which should be recorded. If the fault is
non-fatal, the alarm can be cleared and the system will return to normal operation. If the
fault is fatal, the driver will need to be removed from service as soon as possible. There is
no delay for this alarm.
4.2.12 Flow/Pressure Sensor
An audible and visual Sensor Calibration alarm will indicate if either the flow or pressure
sensor has failed the calibration during the Power-On Self Test. A Warning Screen will
appear indicating which sensor has failed to calibrate and informing the user to remove the
device from service.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 14 of 81
5. 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.
Caution: Used when the driver or accessories used with the driver have the possibility of
being damaged.
Note: Used for statements that could allow for more efficient or convenient operation or
service of the equipment.
The following are warnings, cautions, and notes that will appear within this document. Please
become familiar with their content.
WARNING
Water, excessive water vapor, or debris in the air or oxygen supply gases
may cause the driver to malfunction.
The gas blender and monitoring system are designed for medical grade air
and oxygen only. Do not modify the inlets to accommodate other gas
sources.
WARNING
The driver should only be used after qualified personnel or a technician
has authorized it for use.
WARNING
Oxygen vigorously accelerates combustion. To avoid an explosion hazard,
do not use any instrument or piece of equipment that may have been
exposed to oil or grease contamination.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 15 of 81
WARNING
To avoid the risk of fire or explosion, use this device in well-ventilated
areas away from flammable anesthetics.
WARNING
When driver is connected to power source, keep cords clear of walkways
to avoid possible cord entanglement and strangulation.
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 Immunity of the AirLife®nCPAP System Driver.
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.
DO NOT STERILIZE OR REUSE
WARNING
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.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 16 of 81
WARNING
The power switch does not disconnect the driver from the main power
supply. This can only be accomplished by disconnecting the AC Adapter
from either the driver or the AC outlet.
WARNING
Remove electrical power before servicing the unit. The power switch on
this unit does not isolate the driver from the AC Adaptor; disconnect the
power supply cable to ensure complete isolation.
Disconnect oxygen and medical air.
Eye protection is required when servicing this machine.
WARNING
There is always a risk when using oxygen that the O2 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. Risks include:
•Absorption atelectasis (collapse of lung tissue)
•Hypercapnia (increased carbon dioxide)
•Retrolental hyperplasia (which can cause blindness)
Also, Chemotherapy patients given bleomycin appear to be extremely
sensitive to even relatively low levels of oxygen.
WARNING
Use this product only as directed in the product literature to reduce the
possibility of nasal and skin irritation, and necrosis.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 17 of 81
CAUTION
The correct AC adapter must be used with the driver. Use of an incorrect
AC adapter can damage the internal circuits of the driver.
CAUTION
Although this device meets the requirements of current EMC/RFI
legislation, this does not guarantee immunity from all sources of radiated
energy. Some mobile telephones and other products containing radio
transmitting components may cause a malfunction of the device and
should not be used in the vicinity of the device.
CAUTION
Using the driver without the proper filters can allow dirt or moisture to
enter the system. This will damage the electronic blender, leaving the unit
non-operational.
CAUTION
Ensure that the driver is unplugged from the AC Adaptor and that the
power switch is in the “Off” position before cleaning.
The driver will be damaged if any part of it is immersed in liquid or gas, or
steam sterilized.
Important: Do not spray down the unit with water or cleaning solutions.
CAUTION
This assembly contains electronic components that are ESD sensitive.
ESD control and handling measures should be followed while performing
this process.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 18 of 81
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a
physician or licensed practitioner.
CAUTION
Do not block or occlude flow from exiting the Oxygen Sensor Bleed Port as
this may damage the internal oxygen sensor or create internal leaks.
CAUTION
Any liquid introduced into the gas supplies will cause malfunction of this
driver and the equipment connected to it.
Note:
Always disconnect the machine from facility power, oxygen and medical air
before performing any maintenance procedures.
Note:
To enhance patient safety and comfort, use only with heated humidifiers
and heated wire circuits. The recommended setting is 37 ºC, 100% RH.
Note:
To obtain maximum battery life, it is recommended that the driver remain
connected to an external power source even when it is not in use.
Note:
The driver must have both gases properly connected and within the
specified pressure range in order to pass the initial startup sequence. This
will enable the driver to perform a valid calibration and ensure accurate
FiO2delivery.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 19 of 81
Note:
Class 1 LED product.
Note:
Driver must be used in combination with external monitoring of patient.
Per AARC Clinical Practice Guidelines for the application of CPAP therapy
to neonates, monitoring includes periodic blood gas value sampling,
continuous noninvasive blood gas values via transcutaneous O2and CO2
monitors, continuous noninvasive SaO2values by pulse oximetry, as well
as continuous electrocardiogram and respiratory rate measures.
Note:
Alarms are delayed for 120 seconds after entering Patient Treatment Mode
(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.
Note:
Hospital personnel should keep records of Performance Verification Tests
and Preventative Maintenance, and identify equipment that is authorized for
use.
Note:
In-depth Preventative Maintenance is to be performed by a competent, fully
qualified service technician or engineer. Preventative Maintenance must be
performed at a minimum frequency per the table below.
Note:
Do not replace the Top Case until the Power-On Self Test is complete and
the Patient Treatment Mode Screen (the main screen) appears.

AirLife®nCPAP Driver Service Manual


2008, Cardinal Health Page 20 of 81
6. APPROVED ACCESSORIES LIST
Component Company Catalog Numbers
Disposable Accessories
Cardinal Health RC51-12002
Viasys CC8112E
Hamilton 33078
Delivery Circuit
Fisher and Paykel RT132
Cardinal Health 006905
Viasys
777085-102, 777213,
773386-102
773387-102
11541, 12204,
773388-101, -103
773389-102, -104
Generator Set
(Nasal Prongs are
included with the
Generator Set)
Hamilton 33201
Cardinal Health 006925, 006930,
006935
Nasal Mask
Viasys
777086-101, 777086-
102, 777086-103,
777086-104
Hamilton 37700, 37701, 37702
Reusable Accessories
Heated Humidifier Fisher and Paykel MR730, MR850
Driver Stand w/
extension pole &
basket
006995
Stand Power Strip 006996
Stand Tank Holder
Cardinal Health
006997