AirSep MN134-1 B User Manual
NewLife® Intensity 10
Oxygen Concentrator
Service Manual
AirSep Corporation • 401 Creekside Drive • Buffalo, NY 14228-2085 USA
Telephone: (716) 691-0202 • 24-Hour Fax: (716) 691-4141 • www.airsep.com
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Expedited Product Warranty Check service is always at your fingertips with AirSep:
http://www.airsep.com/Support/Warranty_Information.aspx
OR
In the US or Canada,
dial 866-873-9277
AirSep® is a registered trademark of AirSep Corporation.
•
NewLife® is a trademark of AirSep Corporation.
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Table of Contents
Section 1.0
Introduction
1.1 Equipment Provider Responsibility 1
1.2 Important Notice and Symbol Explanations 2
1.3 Functional Specifications 4
Section 2.0
Operation Check and
Oxygen Concentration Test
2.1 Description of Operation 5
2.2 Operation Check 5
2.3 Alarm System 5
2.3.1 Start Up/Battery Test 6
2.3.2 Power Failure Alarm Test 6
2.4 Oxygen Concentration Test and Specification 6
Section 3.0
Patient Instructions
3.1 Instructions 7
3.2 Routine Maintenance by the Patient 7
3.2.1 Cleaning the Air Intake
Gross Particle Filter 7
3.2.2 Checking the Alarm System Battery 7
Section 4.0
Provider Instructions
4.1 Instructions 8
4.1.1 Air Intake Gross Particle Filter/GPF 8
4.1.2 Felt Filter Replacement 8
4.1.3 Product Filter 8
4.1.4 Battery Replacement 8
4.1.5 Recording Maintenance 9
4.2 Preparing for New Patient Use/Method of 9
Cleaning and Infection Control
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Section 5.0
Main Components
5.1 Components 10
5.2 Cabinet Removal 10
5.2.1 Removing Side Panel(s) 10
5.2.2 Removing Back Panel 10
5.2.3 Removing Lower Front Panel 10
5.2.4 Removing Control Panel 10
5.2.5 Superstructure 10
5.2.6 Caster Replacement 10
5.3 Compressor 11
5.3.1 Compressor Replacement 11
5.3.2 Capacitor Replacement 12
5.4 Solenoid Valves 12
5.4.1 Feed/Waste Valve Replacement 12
5.4.2 Solenoid Valve Coil Replacement 12
5.5 Sieve Beds 13
5.5.1 Sieve Bed Replacement 13
5.6 Cabinet Fan 14
5.6.1 Cabinet Fan Replacement 14
5.7 Circuit Board 14
5.7.1 Circuit Board Replacement 15
5.8 Product Tank Replacement 15
5.9 Product Regulator Check and Setting 16
5.9.1 Setting Product Regulator for Normal Operation 16
5.9.2 Product Regulator Cleaning or 17
Rebuilding
5.10 Circuit Breaker Replacement 17
5.11 I/0 Power Switch Replacement 17
5.12 Buzzer Replacement 18
5.13 Hour Meter Replacement 18
5.14 Flowmeter Replacement 18
5.15 Power Cord Replacement 18
5.16 Oxygen Monitor Circuit Board Replacement 19
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Section 6.0
Troubleshooting
6.1 Operating Pressure Test 20
6.1.1 High Operating Pressure 20
6.1.2 Low Operating Pressure 20
6.2 General Troubleshooting 21
6.3 Troubleshooting Chart 22
6.4 Tool Kit and Pressure Test Gauge 25
Appendix
Exploded Drawings
Wiring Diagram – Intensity 10 120V A
Wiring Diagram – Intensity 10 220/240V B
Control Panel Assembly C
Main Structure Assembly D
Base and Cabinet Components E
Product Tank/Regulator Assembly F
Valve Block Assembly G
Compressor Assembly H
Sieve Bed Assembly I
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1.0 Introduction
1.1 Equipment Provider Responsibility
All Equipment Providers of the NewLife® Intensity 10 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 Intensity 10 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 AirSep Corporation immediately.
! Check the operation of each NewLife Intensity 10 before delivery to a patient.
Confirm the oxygen concentration level is within specifications, as referred to in
Section 2.4. (Test the battery and power disconnect alarm, as described in Section
2.3 of this manual.)
! Deliver NewLife Intensity 10 units only to patients authorized by a licensed health
care provider or physician’s prescription. The NewLife Intensity 10 must not be
used as a life-supporting device. A backup supply of oxygen must be available.
! Instruct patients how to use the NewLife Intensity 10 in conjunction with the Patient
Manual.
! Instruct patients to notify their licensed health care provider/physician if they
experience any signs of discomfort.
! Instruct each patient how to perform routine maintenance of the air intake gross
particle filter and how to check the alarm system battery. (Refer to Section 3.2.)
! Be available to provide service to each patient at any time.
! Maintain the NewLife Intensity 10 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
AirSep parts for replacement in NewLife Intensity 10 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 Intensity 10 unit. Oxygen
accelerates the combustion of flammable substances.
1/
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1.2 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
Intensity 10 Oxygen Concentrator. These symbols are referenced from the appropriate
International Electrotechnical Commission (IEC) standards:
Symbol
Description
Symbol
Description
On (power switched on)
Do not disassemble
Off (power switched off)
Consult instructions for use
Type B device
Keep in vertical position
Class II device
Fragile – handle with care
Do not smoke
Oxygen concentration warning
LED
Complies with the 93/42/EEC
directive drawn up by the
approved organization n˚ 0459
Caution: US federal law restricts
this device for sale or rental by or
on order of a licensed healthcare
provider
Do not expose to open flames
Gas outlet, connection to the
circuit
Do not grease
WEEE Directive
Consult the accompanying
documents
Keep unit and accessories dry
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Method for disposing of waste: All waste from the NewLife Intensity 10 (patient circuit,
etc.) must be disposed of using appropriate methods.
Method for disposing of the device: In order to preserve the environment, the
concentrator must only be disposed of using the appropriate methods.
Conformity with EN 60-601 (§ 6.8.2 b):
“The manufacturer, assembler, installer or importer are not considered to be responsible
themselves for the consequences on the safety, reliability and characteristics of a device
unless:
- The assembly, fitting, extensions, adjustments, modifications, or repairs have been
performed by persons authorized by the party in question.
- The electrical installation of the corresponding premises complies with IEC regulations.
- The device is used in accordance with the instructions for use.” If the replacement parts
used for the periodic servicing by an approved technician do not comply with the
manufacturer’s specifications, the latter is absolved from all responsibility in the event of
an accident. Do not open the device while in operation: risk of electrical shock. This
device complies with the requirements of the 93/42/EEC European directive but its
operation may be affected by other devices being used close by, such as diathermy and
high frequency electro-surgical equipment, defibrillators, short wave therapy equipment,
mobile telephones, CB and other portable devices, microwave ovens, induction plates or
even remote control toys, and more generally electromagnetic interferences, which exceed
the levels specified by the EN 60601-1-2 standard.
Classification
Type of protection against electric shock:
Class II Protection from electric shock is achieved by DOUBLE INSULATION.
Protective earthing or reliance upon installation conditions are not required.
Degree of protection against electric shock:
Type B Equipment providing a particular degree of protection against electric
shock, particularly regarding:
1) allowable leakage current;
2) reliability of protective earth connection (if present).
Not intended for direct cardiac application.
Degree of protection against harmful ingress of water:
Drip-proof equipment – IPX1.
Equipment provided with an enclosure preventing entry of such an amount
of falling liquid as might interfere with the satisfactory and safe operation
of the equipment.
Method of cleaning and infection control allowed:
Please refer to the Maintenance section in the NewLife Intensity 10 Service
Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suitable for such application.
Mode of operation: Continuous duty.
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1.3 Functional Specifications
Oxygen Concentration: 2-9 LPM: 92% +3.5/-3%
10 LPM: 90% +5.5/-3%
(Based on 70°F [21°C] at sea level)
Accuracy: Flowmeter ± 10% or ± 200ml of indicated flow, whichever is
greater.
Response Time: Allow 5 minutes to attain maximum oxygen concentration.
Positioning: Operate the unit in an upright position, maintaining at least
12 inches (30.5cm) of open space on all sides for ventilation.
Dimensions: 27.5 in. high x 16.5 in. wide x 14.5 in. deep
(69.9 cm high x 41.9 cm wide x 36.8 cm deep)
Weight: 58 lb; shipping weight – 65 lb
(26.3 kg; shipping weight – 29.5 kg)
Electrical: 120 VAC, 60 Hz, 6.0 amps, 590 watts
220-240 VAC, 50 Hz, 3.0 amps, 590 watts
Two-prong polarized plug
Double-insulated cabinet
Alarms: Power Failure
Low Oxygen Concentration (with optional Oxygen Monitor)
Low Pressure
High Pressure
High Temperature
Battery Test
Operating Temperature 41°F to 104°F (5°C to 40°C) for 120 VAC 60 Hz models
Range: 41°F to 95°F (5°C to 35°C) for 220-240 VAC 50 Hz models
Storage Temperature -4°F to 140°F (-20°C to 60°C)
Range:
Humidity: Up to 95% (non-condensing)
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2.0 Operational Check and Oxygen Concentration Test
2.1 Description of Operation
Air is drawn into the NewLife Intensity 10 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. The
NewLife Intensity 10 unit delivers up to 95.5% oxygen at flow rates from 2-10 lpm.
2.2 Operation Check
AirSep tests every NewLife Intensity 10 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 I/0 power switch to the “I” position. Check to
see that the following occurs:
a. A continuous alarm sounds for approximately five seconds. See the
troubleshooting chart in Section 6.3 of this manual if the unit’s
alarm does anything other than sound for five seconds.
b. The compressor runs and flow is indicated in flowmeter.
c. OPTIONAL: The Oxygen Monitor’s amber light remains on until
the oxygen concentration reaches 85% ±3% (approximately two
minutes). Perform an oxygen concentration test, as described in
Section 2.4.
2.3 Alarm System
The NewLife Intensity 10 Oxygen Concentrator is equipped with a battery-powered alarm
system, which sounds a continuous and loud alarm when a power failure occurs. It sounds
an intermittent alarm if the high or low pressure indicators are activated or if the optional
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oxygen monitor detects lower than therapeutic levels of oxygen concentration. The alarm
remains on until you correct the alarm condition or you set the I/0 power switch to the “0”
position. Refer to Section 6.0 for a list of probable alarm causes.
2.3.1 Start Up/Battery Test
Each time the NewLife Intensity 10 unit is turned on, an alarm should sound for
approximately five seconds.
The audio alarm must sound for approximately five seconds each time
the unit is turned to the “I” position to indicate the battery is in good
condition.
2.3.2 Power Failure Alarm Test
To test the power failure alarm, disconnect the unit from power, set the l/0 power
switch to the “I” position. This should activate the audio alarm. If it does not, refer
to the troubleshooting chart in Section 6.3 of this manual.
2.4 Oxygen Concentration Test and Specification
To ensure that the unit’s output of oxygen is within specification, you must perform a test
of the oxygen concentration. Test the unit upon delivery to a patient and at periodic
intervals. Equipment Providers need to establish and implement a protocol to check
oxygen concentration.
1. If a humidifier bottle is used, disconnect it.
2. Connect a calibrated oxygen concentration analyzer to the oxygen outlet.
3. Verify that the product flow rate delivered by the unit matches the patient’s
prescription and does not exceed the capacity of the unit.
4. Set the unit’s l/0 power switch to the “I” position. Allow approximately five
minutes for the oxygen concentration to stabilize. Take oxygen concentration
readings and verify levels are within specification at the liter flow being tested.
5. Disconnect the oxygen analyzer, and reconnect the humidifier bottle (if used).
Do not measure oxygen concentration output after the product stream
passes through a humidifier bottle, or erroneous readings will result.
AirSep NewLife Intensity 10 Concentration Specifications
Liter
Flow Oxygen Concentration In Spec
2-9 lpm 92% +3.5/-3% 89% or higher
10 lpm 90% +5.5/-3% 87% or higher
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3.0 Patient Instructions
3.1 Instructions
It is important that patients thoroughly understand how to operate the AirSep NewLife
Intensity 10 unit. This enables proper treatment, as prescribed by a licensed health care
provider/physician. If patients experience any discomfort or the unit alarms, they must
notify their licensed health care provider/physician immediately.
You, as the Equipment Provider, are responsible to see that each patient receives the
Patient Manual. Explain each step in the operation of the unit to the patient in reference to
this manual.
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.
3.2 Routine Maintenance by the Patient
To ensure accurate output and efficient operation of the unit, the patient must perform two
simple routine maintenance tasks:
! Clean the air intake gross particle filter
! Check the alarm system battery
3.2.1 Cleaning the Air Intake Gross Particle Filter
The patient must clean this filter weekly, as described below. The
filter may require daily cleaning if the NewLife Intensity 10 unit
operates in a harsh environment such as a house heated by wood,
kerosene, or oil, or one with excessive cigarette smoke.
1. Remove the dirty air intake gross particle filter from the back of the NewLife
Intensity 10 unit, and install a clean filter, as described above.
2. Wash the dirty filter in warm soapy water, and rinse.
3. Use a soft absorbent towel to remove excess water.
4. Keep the clean, dry filter readily available for next use.
3.2.2 Checking the Alarm System Battery
The alarm system battery is tested each time the l/0 power switch is set to the “l”
position. A continuous alarm sounds for approximately five seconds to indicate a
good battery. If the alarm does anything other than sound for five seconds, instruct
the patient to call the Equipment Provider immediately.
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