AirSep MN138-1 H User Manual

MN138-1 Rev H

02/14

Oxygen Concentrator
Service Manual

For VisionAire, VisionAire 2 & VisionAire 3 Models

AirSep Corporation · 401 Creekside Drive · Buffalo, NY 14228-2085 USA

Telephone: [phone] · 24-Hour Fax: [phone] · www.airsep.com

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____________________________________________________________________________________

Expedited Product Warranty Check service is always at your fingertips with AirSep:

http://www.airsep.com/medical/equipmentproviders.html

OR

In the US or Canada,

dial 866-873-9277

AirSep® is a registered trademark of AirSep Corporation.

•

VisionAire™ 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 5

Section 2.0

Operation Check
and Oxygen
Concentration Test

2.1 Description of Operation 6

2.2 Operation Check 6

2.3 Alarm System 6

2.3.1 Start Up 7

2.3.2 Power Failure Alarm Test 7

2.3.3 No Flow Alarm Test 7

2.4 Oxygen Concentration Test and Specification 7

Section 3.0

General Instructions

3.1 Instructions 8

3.2 Patient, Provider, and Routine Maintenance 9

3.2.1 Product Filter – No Maintenance Required 9

3.2.2 Preparing for New Patient Use/Method 9
of Cleaning and Infection Control

Section 4.0

Main Components

4.1 Components 10

4.2 Cabinet Removal 10

4.2.1 Removing Front Panel 10

4.2.2 Removing Back Panel 10

4.3 Compressor 10

4.3.1 Compressor Replacement 11

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4.3.2 Capacitor Replacement 12

4.4 Solenoid Valves 12

4.4.1 Valve Manifold Replacement 12

4.4.2 Solenoid Valve Coil Replacement 14

4.5 Sieve Beds 14

4.5.1 Sieve Bed Replacement 14

4.6 Cabinet Fan 15

4.6.1 Cabinet Fan Replacement 15

4.7 Circuit Board 16

4.7.1 Circuit Board Replacement 17

4.8 Product Regulator Check and Setting 18

4.8.1 Setting Product regulator for Normal 18
Operation

4.8.2 Product Regulator Lockout 18

4.8.3 Back Pressure Correction 19

4.8.4 Product Regulator Cleaning or Rebuilding 19

4.9 Circuit Breaker Replacement 20

4.10 l/0 Power Switch Replacement 20

4.11 Hour Meter Replacement 21

4.12 Flow Meter Replacement 21

4.13 Power Cord Replacement 22

4.14 Oxygen Monitor Circuit Board Replacement 23

4.15 Mixing Tank Replacement 23

4.16 Exhaust Muffler Replacement 23

4.17 Caster Replacement 24

4.18 Roller Base Replacement 25

4.19 Air Outlet Option (if equipped) 25

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Section 5.0

Troubleshooting

5.1 Operation Pressure Test 26

5.1.1 High Operating Pressure 26

5.1.2 Low Operating Pressure 26

5.2 General Troubleshooting 27

5.3 Troubleshooting Chart 28

5.4 Tool Kit and Pressure Test Gauge 31

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Appendix

Exploded Drawings

Wiring Diagram - VisionAire A

Wiring Diagram – VisionAire 2, VisionAire 3 B

Valve Wire Harness – WH105-1 C

Main Assembly D

Center Section Assembly E

Compressor Enclosure Assembly F

Compressor Assembly G

Valve Manifold Assembly H

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1.0 Introduction

1.1 Equipment Provider Responsibility

All Equipment Providers of the VisionAire™ 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 VisionAire 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 VisionAire unit before delivery to a patient. Confirm the

oxygen concentration level is within specifications as referred to in Section 2.4. (Test the
power disconnect alarm as described in Section 2.3 of this manual.)

! Deliver VisionAire units only to patients authorized by a licensed health care provider or

physician’s prescription. The VisionAire oxygen concentrator must not be used as a life­supporting device. A backup supply of oxygen must be available.

! Instruct patients how to use VisionAire in conjunction with the Patient Manual.
! Instruct patients to notify their licensed health care provider/physician if they experience

any signs of discomfort.

! Be available to provide service to each patient at any time.
! Establish and implement a protocol to check oxygen concentration.

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 VisionAire unit. Oxygen accelerates the
combustion of flammable substances.

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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/Abbreviations

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 AirSep’s
VisionAire Oxygen Concentrators. These symbols are referenced from the appropriate
International Electro-technical Commission (IEC) standards:

Symbol

Description

Symbol Description

ON (power switch on)
OFF (power switch off)

No smoking

Do not disassemble

Type B equipment

Consult instructions for use

Warning – Describes a hazard or

unsafe practice that if not avoided
can result in severe bodily injury,
death or property damage

Class II Device

Caution – Describes a hazard or

unsafe practice that if not avoided
can result in minor bodily injury or
property damage

Complies with the 93/42/EEC directive
drawn up by the approved organization
No. 0459

Note – Provides information
important enough to emphasize
or repeat

Safety agency for CAN/CSA C22.2 No.

601.1 M90 for medical electrical
equipment

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Symbol

Description

Symbol Description

Consult the accompanying
documents

Keep unit and accessories dry
Use no oil or grease

Proper disposal of waste of electrical
and electronic equipment required

Oxygen outlet connection to the
cannula

Do not expose to open flames

Caution: Federal law (USA)
restricts this for sale or rental by
or on the order of a physician or
licensed health care provider.

Keep in the vertical position
Fragile – handle with care

Oxygen concentration warning LED

See Instructions

Method disposing of waste: All waste from the VisionAire (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 is 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.

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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 is 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:

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 General Instructions section in the VisionAire 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: 1-5 liters per minute at 90% +5.5/-3%

1-3 liters per minute at 90% +5.5/-3% (VisionAire 3)
⅛-2 liters per minute at 90% +5.5/-3% (VisionAire 2)
(Based on 70°F [21°C] at sea level)

Accuracy: ± 10% of indicated flow setting, or ± 200 ml, 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: 20.8 in. high, 14.1 in. wide, 11.5 in. deep

(52.8 cm high, 35.8 cm wide, 29.2 cm deep)

Weight: 30 lb; shipping weight – 37 lb

(13.6 kg; shipping weight – 16.7 kg)

Electrical (+/- 10%):

115VAC, 60 Hz, 3 amps, 290 watts

115VAC, 60 Hz, 3 amps, 190 watts (VisionAire 3)
115VAC, 60 Hz, 3 amps, 200 watts (VisionAire 2)
220-240 VAC, 50 Hz, 1.5 amps, 290 watts
220 VAC, 60 Hz, 1.5 amps, 290 watts
230 VAC, 50 Hz, 1.5 amps, 180 watts (VisionAire 2)
230 VAC, 50 Hz, 1.5 amps, 175 watts (VisionAire 3)

Alarms: Power Failure

Low Oxygen Concentration (with optional Oxygen Monitor)

Low Pressure

High Pressure
High Temperature
No Flow

Electrical Shock Class II, Type B
Protection:

Operating Temperature 41 to 105°F (5 to 40°C)
Range:

Storage Temperature -4 to 140°F (-20 to 60°C)
Range:

Humidity: 15 – 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 VisionAire Oxygen Concentrator. For overall, sound efficiency, before air
enters the compressor, it passes through the unit’s intake muffler. Pressurized air then exits the
compressor and moves to the valve manifold. The valve manifold incorporates the use of five
two-way solenoid valves which control the flow of air and oxygen in and out of the molecular
sieve beds. The unique property of molecular sieve enables it to physically attract (adsorb)
nitrogen when air passes through this material, thus producing high concentration 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, flow meter, and finally exits the unit. The
VisionAire unit delivers up to 95.5% oxygen at the prescribed flow rate.

2.2 Operation Check

AirSep tests every VisionAire 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. Plug in the power cord of the unit, 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 four seconds. See the

troubleshooting chart in Section 5.0 of this manual if the unit’s alarm does
anything other than sound for four seconds.

b. The compressor runs and flow is indicated in flow meter.
c. OPTIONAL: The Oxygen Monitor’s amber light will remain on for four

minutes upon startup regardless of unit’s concentration. After four
minutes, the light will go out if the concentration level has reached
minimum concentration requirements.

d. Perform an oxygen concentration test, as described in Section 2.4.

2.3 Alarm System

The VisionAire Oxygen Concentrator is equipped with an alarm system, which sounds an

intermittent alarm when a power failure or other alarm condition occurs.

The intermittent alarm sounds are displayed in the following table:

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VisionAire Intermittent Alarm Indicators

Condition

No
Power

Low O2

Low
Pressure

High
Pressure

High
Temperature

No
Flow

Audible
Alarm

One beep

Two
beeps

Three
beeps

Four
beeps

Five
beeps

Six
beeps

If the high pressure alarm is activated, the compressor and valves will shut down, and the
audible four–beep alarm will continue. This alarm remains on until you set the I/0 power switch
to the “0” position.
Refer to Section 5.0 for alarm identifications, and a list of probable alarm causes.

2.3.1 Start Up

Each time the VisionAire unit is turned on, an alarm should sound for approximately four
seconds.

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 audible one-beep alarm.

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 No Flow Alarm Test

To test the no flow alarm, place thumb over oxygen outlet to completely block flow for
approximately 10-15 seconds. The flow meter ball should drop to zero and the 6-beep alarm
should be activated. (Note: not all units were originally manufactured with a no flow alarm.
Units equipped with main circuit boards prior to rev. R will not have this feature.)

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.

Do not measure oxygen concentration output after the product stream passes
through a humidifier bottle, or erroneous readings will result.

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3.0 General Instructions

3.1 Instructions

It is important that patients thoroughly understand how to operate the AirSep VisionAire unit.
This enables proper treatment as prescribed by a qualified, 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.

Smoking while using oxygen is the number one cause of fire, injury, and death.
You must follow these safety warnings:

Do not allow smoking, candles, or open flames within the same room of the device
or oxygen-carrying accessories.

Smoking while wearing an oxygen cannula may result in facial burns and possibly
death.

Removing the cannula and placing it on surfaces such as bedding, sofas, or other
cushion material will cause a flash fire when exposed to a cigarette, heat source, or
flame.

If you smoke, you must follow these 3 life-saving steps: turn off the oxygen
concentrator, take off the cannula, and leave the room where this device is located.

“No Smoking – Oxygen in Use” signs must be prominently displayed in the home
or where the oxygen concentrator is in use. Patient and their caregivers must be
informed about the dangers of smoking in the present of, or while using, medical
oxygen

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.

Electrical shock hazard. Disconnect the power cord from the electric outlet before
you clean the unit to prevent accidental electrical shock and burn hazard. Only your
Equipment Provider or a qualified service technician should remove the covers or
service the unit.

Care should be taken to prevent the VisionAire from getting wet or allowing any
liquid to enter the unit. This can cause the unit to malfunction or shut down, and
cause an increased risk for electrical shock or burns.