AirSep Visionaire Bedienungsanleitung

MN138-1 Rev J

Oxygen Concentrator

Service Manual

For VisionAire, VisionAire 2 & VisionAire 3 Models

ii MN138-1 Rev J

____________________________________________________________________________________

Expedited Product Warranty Check service is available at 800-482-2473

iii MN138-1 Rev J

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

iv MN138-1 Rev J

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

v MN138-1 Rev J

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

MN138-1 Rev J

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 life-

supporting 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.

MN138-1 Rev J

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 BF 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

Safety agency for CAN/CSA C22.2 No.

601.1 M90 for medical electrical

equipment

Note –Provides information

important enough to emphasize

or repeat

See Instructions

MN138-1 Rev J

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

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.

MN138-1 Rev J

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 BF 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.

MN138-1 Rev J

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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