C-Aire NewLife Elite User manual

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NewLife Family Technical Manual MN240-1

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Table of Contents
Section 1.0
Introduction
1.1 Important Notice and Symbol Explanations 5
1.2 Equipment Provider Responsibility 12
1.3 Functional Specifications 13
Section 2.0
Operation Check and
Oxygen Concentration Test
2.1 Description of Operation 17
2.2 Operation Check 17
2.3 Alarm System 18
2.3.1 Start Up Test 19
2.3.2 Power Failure Alarm Test 19
2.3.3 General Malfunction Alarm Test 19
2.3.4 Low O2Alarm Test 19
2.3.5 Oxygen Concentration Test and Specifications 20
Section 3.0
Patient Instructions
3.1 Instructions 21
3.2 Routine Maintenance by the Patient 21
3.2.1 Cleaning the Air Intake
Gross Particle Filter 21
Section 4.0
Provider Instructions
4.1 Instructions 22
4.1.1 Air Intake Gross Particle Filter/GPF 22
4.1.2 Product Filter 22
4.1.3 Recording Maintenance 23
4.2 Preparing for New Patient Use/Method of 23
Cleaning and Infection Control

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Section 5.0
Main Components 5.1 Components 24
5.2 Cabinet Removal 24
5.2.1 Removing Side Panel(s) 24
5.2.2 Removing Back Panel 24
5.2.3 Removing Lower Front Panel 24
5.2.4 Removing Control Panel 24
5.2.5 Superstructure 24
5.2.6 Caster Replacement 24
5.3 Compressor 25
5.3.1 Compressor Replacement 26
5.3.2 Capacitor Replacement 26
5.4 Solenoid Valves 27
5.4.1 Feed/Waste Valve Replacement 27
5.4.2 Solenoid Valve Coil Replacement 28
5.5 Sieve Beds 29
5.5.1 Sieve Bed Replacement 29
5.6 Cabinet Fan 30
5.6.1 Cabinet Fan Replacement 30
5.7 Circuit Board 31
5.7.1 Circuit Board Replacement 31
5.8 Product Tank Replacement 32
5.9 Product Regulator Check and Setting 33
5.9.1 Setting Product Regulator for Normal Operation 33
5.9.2 Product Regulator Cleaning or 34
Rebuilding
5.10 Circuit Breaker Replacement 35
5.11 ON/OFF Power Switch Replacement 35
5.12 Buzzer Replacement 35

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5.13 Hour Meter Replacement 36
5.14 Flowmeter Replacement 36
5.15 Power Cord Replacement 37
5.16 Oxygen Monitor Circuit Board Replacement 37
Section 6.0
Troubleshooting
6.1 Operating Pressure Test 38
6.1.1 High Operating Pressure 38
6.1.2 Low Operating Pressure 39
6.2 General Troubleshooting 39
6.3 Troubleshooting Chart 40
6.4 Tool Kit and Pressure Test Gauge 43
Section 7.0
EMC TESTING
7.1 EMC Testing 44

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1.0 Introduction
1.1 Important Notice and Symbol Explanations
As you read the manual, pay special attention to the WARNING, CAUTION, and NOTE
messages. They identify safety guidelines or other important information as follows:
Describes a hazard or unsafe practice that can result in severe bodily injury or
death.
Describes a hazard or unsafe practice that can result in minor bodily injury or
property damage.
Provides information important enough to emphasize or repeat.
Symbols are frequently used on equipment in preference to words with the intention of
lessening any possibility of misunderstanding caused by language differences. Symbols
can also permit easier comprehension of a concept within a restricted space.
The following table is a list of symbols and definitions that may be used with the NewLife
Oxygen Concentrator. These symbols are referenced from the appropriate International
Electro-technical Commission (IEC) standards:

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1.2 Equipment Provider Responsibility
All Equipment Providers of the NewLife®Oxygen Concentrator must assume
responsibilities for handling, operational check-out, patient instruction, and oxygen
concentration checks. These responsibilities are outlined below and throughout this
manual.
As an Equipment Provider, you must do all of the following:
▪Inspect the condition of each NewLife unit immediately upon delivery to your
business location. Note any sign of damage on the delivery receipt, and report it
directly to both the, freight company and CAIRE, Inc. immediately.
▪Check the operation of each NewLife before delivery to a patient. Confirm the
oxygen concentration level is within specifications.
▪Deliver NewLife units only to patients authorized by a licensed health care provider
or physician’s prescription. The NewLife must not be used as a life-supporting
device. A backup supply of oxygen must be available.
▪Instruct users how to use the NewLife in conjunction with the User Manual.
▪Instruct users to notify their licensed health care provider/physician if they
experience any signs of discomfort.
▪Instruct each user how to perform routine maintenance of the air intake gross
particle filter (Refer to Section 3.2.1.)
▪Be available to provide service to each user at any time.
▪Maintain the NewLife in accordance with Section 4.0.
▪Establish and implement a protocol to check oxygen concentration.
▪Repair components and replace parts only as outlined in this manual. Use only
CAIRE parts for replacement in NewLife Oxygen Concentrators.
This unit is not a life-support device. Geriatric, pediatric, or any other
patient unable to communicate discomfort while using this oxygen
concentrator may require additional monitoring. Patients with hearing
and/or sight impairments may need assistance with monitoring the
alarms.
This device supplies high-concentration oxygen that promotes rapid
burning. Do not allow smoking or open flames within the same room of
(1) this device, or (2) any oxygen-carrying accessory. Failure to observe
this warning can result in severe fire, property damage, and/or cause
physical injury or death.
Use no oil, grease, or petroleum-based or other flammable products on
or near nasal end of cannula or on the unit. Oxygen accelerates the
combustion of flammable substances.

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1.3 Product Specifications
5 Liter Concentrators
8 Liter Concentrators
10 Liter Concentrators
Oxygen Concentration:
(1)
1-3 LPM: 95.5% - 92.0%
4 LPM: 92% ± 3%
5 LPM: 90% ± 3%
2-7 LPM: 92% ± 3%
8 LPM: 90% ± 3%
2-9 LPM: 92% ± 3%
10 LPM: 90% ± 3%
Physical Characteristics
Height: 72.4 cm (28.5 in.)
Width: 40.0 cm (15.7 in.)
Depth: 36.8 cm (14.5 in.)
Weight: 24.5 kg (54.0 lb.)
Height: 69.9 cm (27.5 in.)
Width: 41.9 cm (16.5 in.)
Depth: 36.8 cm (14.5 in.)
Weight: 24.5 kg (54.0 lb.)
Shipping Weight: 28.1 kg
(62.0 lb.)
Height: 69.9 cm (27.5 in.)
Width: 41.9 cm (16.5 in.)
Depth: 36.8 cm (14.5 in.)
Weight: 26.3 kg (58.0 lb.)
Shipping Weight: 29.9 kg (66.0
lb.)
Electrical Power:
350 Watts –5 LPM model
Two-prong polarized plug
Double insulated cabinet
North American Models:
120 VAC, 60 Hz, 4.0 amps
Export Models:
230 VAC, 50 Hz, 2.0 amps
230 VAC, 60 Hz, 2.0 amps
Double-insulated cabinet
410 watts –8 LPM model
Two-prong polarized plug
Double insulated cabinet
North American Models:
120 VAC, 60 Hz, 4.0 amps
Export Models:
230 VAC, 50 Hz, 2.0 amps
230 VAC, 60 Hz, 2.0 amps
600 Watts –10 LPM model
Two-prong polarized plug
Double insulated cabinet
North American Models:
120 VAC, 60 Hz, 6.0 amps
Export Models:
230 VAC, 50 Hz, 3.0 amps
Alarms:
Power Failure
General Malfunction
Low oxygen concentration (with Oxygen Monitor option)
Temperature: (2)
Operational: 41°F to 104°
(5°C to 40°C)
Storage: -4°F to 140°F
(-20°C to 60°C)
15-95% Humidity
Operational: 41°F to 104°F
(5°C to 40°C)
Storage: -4°F to 140°F
(-20°C to 60°C)
15-95% Humidity
Operational: 41°F to 104°F
(5°C to 40°C)
Storage: -4°F to 140°F
(-20°C to 60°C)
15-95% Humidity

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Product Specifications Continued
Relief Pressure
45 PSIG (310 kPa) @ Compressor
O2Monitor
Yellow caution light Range: Below 82% (+ 3%) O2
Audible Alarm: After several minutes below specified Range
Max Pressure = 60 PSIG (414kPa)
Operating temperature Range: -31°F to 158°F (-35°C to 70°C)
Operational Humidity: 0 to 100%
Altitude
Tested all models at -381 m to 3,048 m (-1,250 ft to 10,000 ft) (700-1060hPa)
(87% O2for the Elite)
(85% for Intensity 10)
Sound Pressure Level
Elite:
EUT: 53 dB(A) (Max 60 dB(A) allowed)
Chamber Background Noise: 30dB(A) Max
Intensity:
EUT: Under 60 dB(A)
Chamber Background Noise: 30dB(A) Max
Sound Power Level
Elite: 60.2 dB(A)
Intensity 8: No data
Intensity 10: 69 dB(A)
Fire Prevention System
Read warnings and cautions on flammable cleaning solvents, grease, oil and “NO” smoking at the
beginning of this manual.
There are three legs of the thermal event triangle: Fuel, Oxidizer and Ignition source. Two of the
three are present: Cotton fiber, skin lotion, facial hair and some plastics are hydrocarbon by
nature. Oxygen of 90% level runs through the plastic tubing to cannula. Therefore, DO NOT
allow sparking, flame from a lighter or match or other elevated temperatures beyond operational
range to reduce risk of thermal event.
To further improve safety, install OxySafe Kit Part No. 20628667 and 20628668.
Fire Prevention
O2level inside Concentrator at or below 25% and in combination with highest safety test
temperature poses no threat to any thermal event.
Further protection is double insulation of internal wiring and sufficient electrical safety testing to
ensure equipment shutdown in overheat

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Product Specifications Continued
5 Liter
Concentrators
8 Liter
Concentrators
10 Liter Concentrators
Excessive
Temperatures –Outlet
(2)
Maximum O2Outlet Temperature Rise
+ 3 OC (5.4 OF)
Maximum O2Outlet Temperature Rise
+ 4.5 OC (8.1OF)
Flow Rate Range
1% maximum difference in flow rate of
allowable ± 10%
Within ± 10% of allowable flow rate
O2Concentration
at Extreme Voltage
Conditions
Voltage Extreme
% Volume
132 V
94.6
103 V
94.0
253 V
91.0
195 V
90.0
Voltage Extreme
% Volume
132 V
88.0 to 91.0
103 V
87.5 to 90.5
253 V
88.0 to 91.0
195 V
87.1 to 90.0
Mean O2
Concentration
Voltage
Extreme
Mean O2
% Individual
Deviation from Mean
(± 3% allowable)
132 V
94.6
0.6
103 V
94.0
0.6
253 V
91.0
0.6
195 V
90.0
1.4
Voltage
Extreme
% Individual
Deviation from Mean
(± 3% allowable)
132 V
0.6
103 V
0.6
253 V
0.6
195 V
1.4
Mean Flow Rate
Voltage
Extreme
Mean
Flow
% Individual
Deviation from Mean
(± 10% allowable)
132 V
4.87
0.8
103 V
5.11
0.8
253 V
4.99
1.4
195 V
5.00
1.4
Voltage
Extreme
% Individual
Deviation from Mean
(± 10% allowable)
132 V
1.8
103 V
3.7
253 V
0.6
195 V
0.4

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Product Specifications Continued
5 Liter Concentrators
8 Liter Concentrators
10 Liter Concentrators
Backpressure
Effect Test
Flow
Applied Pressure *
5.00 LPM
@ 0 PSIG (0 kPA)
4.75 LPM
@ 1 PSIG (7 kPA)
Flow
Applied Pressure *
8.00 LPM
@ 0 PSIG (0 kPA)
7.86 LPM
@ 1 PSIG (7 kPA)
Flow
Applied Pressure *
10.00 LPM
@ 0 PSIG (0 kPA)
9.65 LPM
@ 1 PSIG (7 kPA)
Outlet
Pressure Test
Actual
Pressure
Max Allowable
Limit
7.3 PSIG
(50.3 kPA)
8.8 PSIG
(60.7 kPA)
Actual
Pressure
Max Allowable
Limit
21.9 PSIG
(151 kPA)
22.0 PSIG
(151.7 kPA)
Actual
Pressure
Max Allowable
Limit
21.9 PSIG
(151 kPA)
22.0 PSIG
(151.7 kPA)
(1) Based on 21oC (70°F) at a nominal operating pressure range of 0-7 kPa (0-1 PSIG back pressure)
and 14.7 PSI (101 kPa).
(2) Operating outside of these operational specifications can affect performance.
Accuracy: ±10% of indicated flow setting or ±200 mL, whichever is greater. Based on an atmospheric
pressure range of 700 kPa to 1060 kPa at 70°F (21°C).

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2.0 Operational Check and Oxygen Concentration Test
2.1 Description of Operation
Air is drawn into the NewLife Oxygen Concentrator through an external air intake gross
particulate filter. Before this air enters the compressor, it passes through the unit’s suction
resonator which, quiets the compressor’s suction sound. Pressurized air then exits the
compressor and passes through a heat exchanger. The heat exchanger reduces the
temperature of the compressed air. Next, a two-way solenoid feed valve directs the air into
one of two sieve beds that contain molecular sieve. The unique property of molecular
sieve enables it to physically attract (adsorb) nitrogen when air passes through this
material, thus producing high concentrated oxygen.
There are two sieve beds: while one produces high concentration oxygen, the other is
purged of the nitrogen it adsorbed (collected) during this pressure swing adsorption (PSA)
cycle. Each adsorber produces oxygen and delivers it to the product tank. Oxygen exits
the product tank through a pressure regulator, flow control valve, and flowmeter.
2.2 Operation Check
CAIRE tests every NewLife Oxygen Concentrator thoroughly after
manufacture. You must perform the following test to ensure that no damage occurred in
shipping or handling.
Do not use extension cords with this unit or connect too many plugs
into the same electrical outlet. The use of extension cords could
adversely affect the performance of the device. Too many plugs into
one outlet can result in an overload to the electrical panel, causing the
breaker/fuse to activate or fire if the breaker or fuse fails to operate.
1. Open and inspect all cartons (that contain units) upon delivery. Unpack the unit
and remove it from the carton. Inspect the unit itself for damage. If the exterior of
a unit’s carton is damaged, or the unit itself is damaged, note it on the freight bill
signed by the driver.
2. Connect unit to power and set the ON/OFF power switch to the ON position. Check
to see that the following occurs:
a. An alarm that sounds for approximately one second with all display
lights illuminated. See the troubleshooting chart in Section 6.3 of
this manual if the unit’s alarm does not sound or display illuminates.
b. The compressor runs and flow is indicated in flowmeter.
c. The Oxygen Monitor’s amber light remains on until the oxygen
concentration reaches 82% (+ 3%) (approximately two minutes).
Perform an oxygen concentration test, as described in Section 2.3.5.

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2.3 Safety and Alarm Features and Alarm Test Procedures
The NewLife Oxygen Concentrator is equipped with an audible and visual alarm system.
There are alarms for power failure, general malfunction, and low oxygen concentration.
The alarm will remain on until the alarm condition is corrected, or until the power is
switched off. Refer to Section 6.3 for a list of probable alarm causes.
A pressure relief valve is fitted to the compressor outlet and is calibrated to 280 kPA (40
PSIG). Thermal safety is ensured by a thermostat situated in the stator winding of the
compressor (135°C / 275 °F).
Three LED NewLife Units:
Figure 1: Device warning label and alarm display. Note this is valid for units
manufactured January 1st, 2019 and later.
Oxygen Monitor: In the event the oxygen monitor detects an oxygen concentration below
82% the low oxygen concentration warning light ( ) will illuminate. If the low O2
condition persists an audible intermittent alarm will also activate.
Power Failure: In the event the unit is operating, and a loss of power occurs, the power
warning light ( ) will illuminate and an audible intermittent alarm will activate.
General Malfunction: If any of the conditions listed below occurs, the general
malfunction light ( ) will illuminate and an audible intermittent alarm will activate. This
includes:
•Obstruction to the flow of oxygen such as a pinch or kink in the delivery cannula,
triggered by high product tank pressure **
•High device product tank pressure condition of greater than 33 PSIG (±1)
•Low device product tank pressure condition of less than 5 PSIG (±1)
•High device temperature of greater than 135°C (275 °F), triggered by low product
tank pressure if the thermal switch located within the compressor trips (shutting
down the compressor)
** Note: The indication for a “no flow” condition on the NewLife Elite and Dual Flow
NewLife Intensity 10 models is the flow ball dropping to zero. There is no audible alarm
indication for the “no flow” alarm condition on the NewLife Elite manufactured with 3
LEDs. The Single Flow NewLife Intensity 10 model will display the general malfunction
visual and audible alarm in the event of a “no flow” condition, caused by an obstruction to
the outlet port.
Product Filter: ≥ 10 μm filterOne/Zero LED NewLife nits:

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Device warning label Oxygen Monitor Label
Figure 2: Device warning label and oxygen monitor label. Note this is valid for units
manufactured before January 1st, 2019.
Oxygen Monitor (Oxygen Monitor Unit Only): In the event the oxygen monitor detects
an oxygen concentration below 82%, the oxygen monitor will illuminate. The unit needs
approximately two minutes for warm up.
Battery Test: Each time the NewLife unit is turned on, a five-second audible alarm sounds
to indicate the condition of the battery.
NOTE The audio alarm must sound loudly for approximately five seconds each time the
unit is turned to ON to indicate the battery is in good condition.
Power Failure Alarm Test: To test the power failure alarm, take the following step:
Unplug the unit, and set the ON/ OFF switch to the ON position. This should immediately
activate the audio alarm. If it does not, refer to the troubleshooting chart in Section 6.0 of
this manual.
2.3.1 Start Up
Each time the NewLife unit is turned on, an audible signal should sound.
If the unit has not been used for an extended period of time, it needs to
operate for several minutes to recharge the alarm capacitor.
2.3.2 Power Failure Alarm Test
1. Connect the unit to external power.
2. Set the ON/OFF switch to the “ON” position.

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3. While the machine is still operating, disconnect from external power.
4. Verify that the power loss alarm LED illuminates on the front panel and audible
alarm activates. The audible alarm will beep approximately once every 20
seconds.
If the unit has not been used for an extended period of time, it needs to
operate for several minutes to recharge the power failure alarm.
2.3.3 General Malfunction Alarm Test
1. Disconnect the unit from external power.
2. Disconnect the compressor.
3. Connect unit to power and turn it on.
4. Verify that the general malfunction alarm LED illuminates on the front panel
and audible alarm activates after the warm-up period.
5. Turn off the unit and disconnect it from power.
6. Reconnect compressor.
7. Connect unit to power and turn it on.
8. Verify the alarm ceases once the compressor is re-connected.
2.3.4 Low O2Alarm Test
1. Prior to performing this test procedure, ensure the unit has been turned off for at
least 1 hour.
2. Disconnect the unit from external power.
3. Remove zip tie from inlet side of O2monitor assembly.
4. Disconnect inlet tubing from O2monitor assembly.
5. Connect unit to power and turn it on to the highest flow setting.
6. Verify that O2monitor LED illuminates and audible alarm activates after warm-
up period.
7. Turn off the unit and disconnect it from power.
8. Reconnect tubing and re-install zip tie on the O2monitor.
9. Connect unit to power and turn it on to the highest flow setting.
10. Verify the alarm ceases once the tube is re-attached.