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Page 1

VisionAire 2 & 3

User Manual

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2 — MN165-1 M

Sym-

bol

Denition Symbol Denition

Read user manual before operation. See user manual for instructions.

ON (power switch on)

No Smoking Icon: Do not smoke near unit.

OFF (power switch off)

Warnings and Cautions

No serviceable parts inside. Do not open cover.

Type BF equipment (degree of protection against electric shock)

Class II equipment

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

Safety agency for CAN/CSA C22.2 No. 601.1 M90 for medical electrical equipment

Keep unit and accessories dry Use no oil or grease.

Consult the accompanying documents

This symbol is to remind the equipment owners to return it to a recycling facility at the end of its life, per Waste Electrical and Electronic Equipment (WEEE) Directive. Proper disposal of waste of electrical and electronic equipment required.

Oxygen outlet connection to the cannula

Do not expose to open ames

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

Date of Manufacture Name and address of manufacturer

Serial number

Authorized representative in the European Community

Catalog number

User Controls & System Status Indicators

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VisionAire 2 & 3 User Manual — 3

Contents

User Controls & System Status Indicators ................................................................................. 2

Indications for Use ............................................................................................................................ 4

Contraindications for Use ...............................................................................................................4

Safety Guidelines ............................................................................................................................... 4

Introduction ........................................................................................................................................ 8

Concentrator Components ............................................................................................................ 9

Operating Instructions ..................................................................................................................12

Care and Cleaning ...........................................................................................................................13

Troubleshooting ..............................................................................................................................14

Product Specications ...................................................................................................................15

Disposal...............................................................................................................................................19

English: A multilingual version of the manual is available through your equipment provider. Español: Una versión multilingüe del manual está disponible a través de su proveedor de equipo. Français: Une version multilingue du manuel est disponible par l’intermédiaire de votre fournisseur de

matériel. Deutsche: Eine mehrsprachige Version des Handbuchs ist in Ihrer Geräte-Anbieter

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Important!

Safety Instructions are dened as follows:

Indications for Use

Contraindications for Use

Safety Guidelines

WARNING: IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT CAUSE SERIOUS INJURY.

CAUTION: Important information for preventing damage to the VisionAire.

Note: Information needing special attention.

WARNING: IT IS VERY IMPORTANT TO SELECT ONLY THE PRESCRIBED LEVEL OF OXYGEN. DO NOT CHANGE THE FLOW SELECTION UNLESS

YOU HAVE BEEN DIRECTED TO DO SO BY A LICENSED CLINICIAN. THE PORTABLE OXYGEN CONCENTRA TOR MAY BE USED DURING SLEEP UNDER THE RECOMMEN DATION OF A QUALIFIED CLINICIAN.

WARNING: FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE OR RENTAL BY ORDER OF A PHYSICIAN OR OTHER LICENSED HEALTH CARE PROVIDER.

WARNING: THIS UNIT IS NOT TO BE USED FOR LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR ANY OTHER PATIENT UNABLE TO COMMUNICATE DISCOMFORT WHILE USING THIS DEVICE MAY REQUIRE ADDITIONAL MONITORING. PATIENTS WITH HEARING AND/OR SIGHT IMPAIRMENTS MAY NEED ASSISTANCE WITH MONITORING ALARMS.

WARNING: NO MODIFICATION OF THIS EQUIP MENT IS PERMITTED

WARNING: IN CERTAIN CIRCUMSTANCES, THE

USE OF NONPRESCRIBED OXYGEN CAN BE

HAZARDOUS. THIS DEVICE SHOULD ONLY BE

USED WHEN PRESCRIBED BY A PHYSICIAN. WARNING: NOT FOR USE IN THE PRESENCE OF FLAMMABLE

ANESTHETICS. WARNING: AS WITH ANY ELECTRICALLY POWERED DEVICE,

THE USER MAY EXPERIENCE PERIODS OF NONOPERATION AS A RESULT OF ELECTRICAL POWER INTERRUPTION, OR THE NEED TO HAVE THE VISIONAIRE SERVICED BY A QUAL IFIED TECHNICIAN. THE VISIONAIRE IS NOT APPROPRIATE FOR ANY PATIENT WHO WOULD EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE RESULT OF SUCH TEMPO RARY INTERRUPTION.

WARNING: SMOKING WHILE USING OXYGEN IS THE NUMBER ONE CAUSE OF FIRE, INJURY, AND DEATH. YOU MUST FOLLOW THESE SAFETY WARNINGS:

WARNING: DO NOT ALLOW SMOKING, CANDLES, OR OPEN FLAMES WITHIN THE SAME ROOM OF THE DEVICE OR THE OXYGENCARRYING ACCESSORIES.

WARNING: SMOKING WHILE WEARING AN OXYGEN CAN NULA CAN CAUSE FACIAL BURNS AND POSSIBLY RESULT IN DEATH.

WARNING: REMOVING THE CANNULA AND PLACING IT ON CLOTHING, BEDDING, SOFAS, OR OTHER CUSHION MATERIAL WILL CAUSE A FLASH FIRE WHEN EXPOSED TO A CIGARETTE, HEAT SOURCE, SPARK OR OPEN FLAME.

WARNING: IF YOU SMOKE, YOU MUST ALWAYS FOLLOW THESE 3 IMPORTANT STEPS FIRST: TURN OFF THE OXYGEN CONCENTRATOR, TAKE OFF THE CANNULA, AND LEAVE THE ROOM WHERE THIS DEVICE IS LOCATED.

Note: Portable and mobile RF communications equipment can eect medical electrical equipment.

CAUTION: Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider.

WARNING: THIS DEVICE SUPPLIES HIGHCON CENTRATION 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 AC CESSORY. FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE, PROPERTY DAMAGE AND / OR CAUSE PHYSICAL INJURY OR DEATH.

WARNING: DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE GASES. THIS CAN RESULT IN RAPID BURNING CAUSING PROPERTY DAMAGE, BODILY INJURIES OR DEATH.

WARNING: DO NOT LEAVE A NASAL CANNULA ON CLOTH ING, BED COVERINGS OR CHAIR CUSHIONS. IF THE UNIT IS TURNED ON BUT NOT IN USE, THE OXYGEN WILL MAKE THE MATERIAL FLAMMABLE. SET THE I/0 POWER SWITCH TO THE 0 OFF POSITION WHEN THE OXYGEN CONCENTRATOR IS NOT IN USE.

WARNING: USE NO OIL, GREASE, OR PETROLEUMBASED OR OTHER FLAMMABLE PRODUCTS WITH THE OXY GENCARRYING ACCESSORIES OR THE OXYGEN CON CENTRATOR. ONLY WATER BASED, OXYGEN COMPATIBLE LOTIONS OR SALVES SHOULD BE USED. OXYGEN ACCELER ATES THE COMBUSTION OF FLAMMABLE SUBSTANCES.

WARNING: CLEAN THE CABINET, CONTROL PANEL, AND POWER CORD ONLY WITH A MILD HOUSEHOLD CLEANER APPLIED WITH A DAMP CLOTH NOT WET OR SPONGE, AND THEN WIPE ALL SURFACES DRY. DO NOT ALLOW ANY LIQUID TO GET INSIDE THE DEVICE.

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VisionAire 2 & 3 User Manual — 5

CAUTION: In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the Troubleshooting section in this manual. If you cannot

resolve the problem, consult your Equipment Provider. CAUTION: To prevent a void warranty, follow all manufac-

turers’ instructions.

WARNING: SMOKING WHILE USING OXYGEN IS THE NUMBER ONE CAUSE OF FIRE INJURIES AND RELATED DEATHS. YOU MUST FOLLOW THESE SAFETY WARNINGS:

WARNING: DO NOT ALLOW SMOKING, CANDLES, OR OPEN FLAMES IN THE SAME ROOM WITH THE DEVICE OR THE OXYGENCARRYING ACCESSORIES.

WARNING: SMOKING WHILE WEARING AN OXYGEN CAN NULA MAY CAUSE FACIAL BURNS AND POSSIBLY DEATH.

WARNING: IF YOU SMOKE, THESE 3 STEPS MAY SAVE YOUR LIFE: TURN OFF THE OXYGEN CONCENTRATOR, TAKE OFF THE CANNULA, AND LEAVE THE ROOM WHERE THIS DEVICE IS LOCATED.

WARNING: “NO SMOKING  OXYGEN IN USE” SIGNS MUST BE PROMINENTLY DISPLAYED IN THE HOME, OR WHERE OX YGEN IS IN USE. PATIENTS AND THEIR CAREGIVERS MUST BE INFORMED ABOUT THE DANGERS OF SMOKING IN THE PRESENCE OF, OR WHILE USING, MEDICAL OXYGEN.

WARNING: DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE GASES. THIS CAN RESULT IN RAPID BURNING CAUSING PROPERTY DAMAGE, BODILY INJURIES OR DEATH.

WARNING: REMOVING THE CANNULA AND PUTTING IT ON CLOTHING, BEDDING, SOFAS, OR OTHER CUSHION MATERIAL WILL CAUSE A FLASH FIRE WHEN EXPOSED TO A CIGARETTE, HEAT SOURCE, OR FLAME.

WARNING: DO NOT LEAVE A NASAL CANNULA ON OR UNDER CLOTHING, BED COVERINGS OR CHAIR CUSHIONS. IF THE UNIT IS TURNED ON BUT NOT IN USE, THE OXYGEN WILL MAKE THE MATERIAL FLAMMABLE. SET THE OXYGEN CONCENTRATOR TO THE 0 OFF POSITION WHEN THE OXYGEN CONCENTRATOR IS NOT IN USE.

WARNING: DO NOT ATTEMPT ANY MAINTE NANCE OTHER THAN THE POSSIBLE SOLU TIONS LISTED WITHIN THIS MANUAL. DO NOT

REMOVE COVERS, ONLY YOUR EQUIPMENT PROVIDER OR A QUALIFIED SERVICE TECHNICIAN SHOULD REMOVE THE COVERS OR SERVICE THIS DEVICE.

WARNING: ONLY ACCESSORIES RECOMMENDED BY THE MANUFACTURER. USE OF ANY OTHER MAY BE HAZARDOUS, CAUSE SERIOUS DAMAGE TO YOUR OXYGEN CONCENTRATOR AND WILL VOID THE WARRANTY .

CAUTION: Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard.

WARNING: THE MANUFACTURER RECOM

MENDS AN ALTERNATE SOURCE OF SUPPLE

MENTAL OXYGEN IN THE EVENT OF A POWER

OUTAGE, ALARM CONDITION, OR MECHANI CAL FAILURE. CONSULT YOUR PHYSICIAN OR EQUIPMENT PROVIDER FOR THE TYPE OF RESERVE SYSTEM REQUIRED.

WARNING: DO NOT ALLOW EITHER THE AIR INTAKE OR THE AIR OUTLET VENTS TO BECOME BLOCKED. DO NOT DROP OR INSERT ANY OBJECTS INTO ANY OPENINGS ON THE DEVICE. THIS CAN CAUSE THE OXYGEN CONCENTRA TOR TO OVERHEAT AND IMPAIR PERFORMANCE.

WARNING: ELECTRICAL SHOCK HAZARD. TURN OFF THE UNIT AND 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.

WARNING: CARE SHOULD BE TAKEN TO PREVENT THE OXYGEN CONCENTRATOR FROM GETTING WET OR ALLOWING FLUIDS TO ENTER THE UNIT. THIS CAN CAUSE THE UNIT TO MALFUNCTION OR SHUT DOWN, AND CAUSE AN INCREASED RISK FOR ELECTRICAL SHOCK OR BURNS.

WARNING: DO NOT USE LIQUID DIRECTLY ON THE UNIT. A LIST OF UNDESIRABLE CHEMICAL AGENTS INCLUDES BUT IS NOT LIMITED TO THE FOLLOWING: ALCOHOL AND ALCOHOLBASED PRODUCTS, CONCENTRATED CHLORINEBASED PRODUCTS ETHYLENE CHLORIDE, AND OILBASED PRODUCTS PINESOL®, LESTOIL®. THESE ARE NOT TO BE USED TO CLEAN THE PLASTIC HOUSING ON THE OXYGEN CONCENTRATOR, AS THEY CAN DAMAGE THE UNIT’S PLASTIC.

WARNING: THE OXYGEN CONCENTRATOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF AD

JACENT OR STACKED USE IS UNAVOIDABLE, THE DEVICE SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION.

WARNING: NO MODIFICATION OF THIS EQUIPMENT IS PERMITTED.

WARNING: USE OF CABLES AND ADAPTERS OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF CABLES AND ADAPTERS SOLD BY THE MANUFACTURER OF THE MEDICAL ELECTRICAL EQUIPMENT AS REPLACEMENT PARTS FOR INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OF DECREASED IMMUNITY OF THE OXYGEN CONCENTRATOR.

WARNING: USE ONLY ELECTRICAL VOLTAGE AS SPECIFIED ON THE SPECIFICATION LABEL AFFIXED TO THE DEVICE.

WARNING: 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.

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CAUTION: Do not position the unit so that it is dicult to access the power cord.

CAUTION: The concentrator should be located as to avoid smoke, pollutants or fumes.

CAUTION: Ensure concentrator is operated in an upright position.

CAUTION: Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard.

CAUTION: Position the unit away from curtains or drapes, hot air registers or heaters. Be certain to place the unit on a at surface and make sure all sides are at least 1 foot (30 cm) away from a wall or other obstruction. Do not place the unit in a conned area. Choose a dust and smoke free-location away from direct sunlight. Do not operate the unit outdoors unless the unit is plugged into a Ground Fault Circuit Interrupter (GFCI) protected outlet.

CAUTION: Do not operate this unit in a restricted or conned space where ventilation can be limited. This can cause the device to overheat and aect performance.

CAUTION: Do not allow either the air intake or the air outlet vents to be blocked. DO NOT drop or insert any object into any openings on the device. This can cause the Oxygen Concentrator to overheat and impair performance.

CAUTION: The Manufacturer recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure. Consult your physician or Equipment Provider for the type of reserve system required.

CAUTION: It is very important to select only the prescribed level of oxygen. Do not change the ow selection unless you have been directed to do so by a licensed clinician.

CAUTION: The Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician.

CAUTION: Operating or storing the Oxygen Concentrator outside of its normal operating temperature range can impair the performance of the unit. Refer to the specication section of this manual for storage and operating temperature limits.

CAUTION: In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the troubleshooting section of this manual. If you cannot resolve the problem, consult your Equipment Provider.

CAUTION: If the audio alarm is weak or does not sound at all, consult your Equipment Provider immediately.

CAUTION: For units equipped with the oxygen monitor option - Contact your Equipment Provider immediately if the amber OXYGEN MONITOR light remains on for more than 15 minutes and/or the audio alarm activates.

CAUTION: If the humidier bottle tubing is not properly connected to the humidier bottle tting or to the oxygen outlet, an oxygen leak can occur.

AVERTISSEMENT: CET APPAREIL PRODUIT DE L’OXYGÈNE À CONCENTRATION ÉLEVÉE, FAVORISANT UNE COMBUSTION RAPIDE. NE

PAS PERMET TRE DE FUMER OU DES FLAMMES NUES DANS LA MÊME CHAMBRE: 1 CET APPAREIL OU 2 TOUT ACCESSOIRE CONTENANT DE L’OXYGÈNE. NE PAS UTILISER DE PRODUITS À BASE D’HUILE, DE GRAISSE OU DE PÉTROLE SUR OU À PROXIMITÉ DE L’UNITÉ. DÉCONNECTER LE CORDON D’ALIMENTATION DE LA PRISE ÉLECTRIQUE AVANT DE NETTOYER OU DE FAIRE L’ENTRETIEN DE L’UNITÉ.

AVERTISSEMENT: RISQUE DE CHOC ÉLECTRIQUE. NE PAS ENLEVER LES COUVERCLES LORSQUE L’UNITÉ EST BRANCHÉE. SEULS VOTRE FOURNISSEUR D’ÉQUIPEMENT OU UN TECHNICIEN DE SERVICE QUALIFIÉ DEVRAIT ENLEVER LES COUVERCLES OU FAIRE L’ENTRETIEN DE L’UNITÉ.

WARNING: THE OXYGEN CONCENTRATOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF AD

JACENT OR STACKED USE IS UNAVOIDABLE, THE DEVICE SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION.

WARNING: NO MODIFICATION OF THIS EQUIPMENT IS PERMITTED.

WARNING: USE ONLY ELECTRICAL VOLTAGE AS SPECIFIED ON THE SPECIFICATION LABEL AFFIXED TO THE DEVICE.

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VisionAire 2 & 3 User Manual — 7

Note: Cannula must be non-kinking, which can be used for a total length of 25 ft. (7.6 m) max.

Note: Ensure the cannula is fully inserted and secure. You should hear or feel oxygen ow to the prongs of the nasal cannula. If oxygen does not seem to ow, rst verify that the owmeter ball is registering a ow. Then, place the tip of the cannula into a glass of water; if bubbles come out of the cannula, oxygen is owing. If bubbles do not appear, refer to the troubleshooting section of this manual.

Note: Always follow the cannula manufacturer’s instructions for proper use. Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider. Additional supplies are available from your Equipment Provider.

Note: The use of some oxygen administration accessories not specied for use with this oxygen concentrator may impair its performance. Recommended accessories are referenced within this manual.

Note: To Equipment Provider: The following ox ygen administration accessories are recommended for use with the Oxygen Concentrator

• Humidier Bottle: Part No. HU003-1

• Nasal Cannula with 7 feet (2.1 m) of tubing: Part No. CU002-1

• OxySafe Kit: Part No. 20629671

Note: The Manufacturer does not recommend the sterilization of this equipment.

Note: If the unit has not been used for an extended time period, it needs to operate for a minimum of several minutes before power failure alarm can become activated.

Note: For units equipped with the oxygen monitor option When you turn the unit on, it’s normal for the amber OXYGEN MONITOR light to turn on and remain on for up to ve minutes.

Note: The concentrator releases warm air out the bottom of the unit which can permanently discolor temperature sensitive ooring surfaces such as vinyl. The concentrator should not be used over ooring that is sensitive to heat staining. The Manufacturer is not responsible for ooring that becomes discolored.

Note: To prevent a void warranty, follow all manufacturers’ instructions.

Note: Do not attempt any maintenance other than the possible solutions listed within the manual.

Note: Portable and mobile RF communications equipment can eect medical electrical equipment.

Note: There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit.

Note: AirSep oers the OxySafe as an optional accessory. This is intended to be used in conjunction with the Visionaire 2/3 concentrator. For customers in regions requiring compliance to EN ISO 8359:1996-Ammendment1:2012, this accessory will meet this need.

The OxySafe is a thermal fuse to stop the ow of gas in the event that the downstream cannula or oxygen tubing is ignited and burns to the OxySafe. It is placed in-line with the nasal cannula or oxygen tubing between the patient and the oxygen outlet of the Visionaire 2/3.

For proper use of the OxySafe, always refer to the manufacturer’s instructions (included with each OxySafe kit).

AirSep oers an OxySafe kit that includes OxySafe with 2” of tubing to connect to the oxygen outlet; PN 20629671

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Introduction

Operator Prole:

AirSep’s Stationary Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which affect the

efciency of ones lungs to transfer the oxygen in air to their bloodstream. Users can benet from

supplemental oxygen therapy for respiratory care at home, in the hospital, or at a medical facility. Oxygen Concentrator use requires a physician’s prescription, and are not intended for life support use.

Although Oxygen therapy can be prescribed for patients of all ages the typical oxygen therapy patient is older than 65 years of age and suffers from chronic obstructive pulmonary disease (COPD). Patients typically have good cognitive abilities and must be able to communicate discomfort. If the user is unable to communicate discomfort, or unable to read and understand the concentrator labeling and instructions for use, then use is recommended only under the supervision of one who can. If any discomfort is felt while using the concentrator, patients are advised to contact their healthcare provider. Patients are also advised to have back-up oxygen available (i.e. cylinder oxygen) in the event of a power outage or concentrator failure. There are no other unique skills or user abilities required for concentrator use.

This Patient Manual will acquaint you with AirSep’s VisionAire 2 and VisionAire 3 Oxygen Concentrators. Make sure you read and understand all of the information contained in this guide before operating your concentrator. Should you have any questions, your Equipment Provider will be happy to answer them for you.

Why Your Physician Prescribed Oxygen

Many people today suffer from a variety of heart,

lung, and other respiratory diseases. A signicant number of these patients can benet from

supplemental oxygen therapy for respiratory care at home, in the hospital, or at a medical facility.

Oxygen is a gas that makes up 21% of the room air we breathe. Our bodies depend on a steady supply to function properly. Your physician has prescribed supplemental oxygen therapy because your body is not able to get enough oxygen from room air. Oxygen is a non-addictive drug, and your physician prescribed

a ow sufcient to improve your condition.

Please keep in mind that unauthorized oxygen therapy can be dangerous. You must seek medical advice before you use this unit. The Equipment Provider who supplies your oxygen equipment will demonstrate how

to set the prescribed ow rate.

What is an Oxygen Concentrator?

Oxygen concentrators were introduced in the mid1970s and have become the most convenient, reliable source of supplemental oxygen available today. Without an oxygen concentrator, the average patient would require a delivery of 12 bottles/cylinders of oxygen each month. Your oxygen concentrator produces all the oxygen you need, with no deliveries required.

The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gases. In the VisionAire 2 or VisionAire 3 unit, room air passes through a regenerative adsorbent material called molecular sieve. This material separates the oxygen from the nitrogen and other gases. The result is a constant supply of high concentration supplemental oxygen that is delivered to the patient.

Note: There is never a danger of depleting the oxygen in a room when you use your VisionAire 2 or VisionAire 3 unit.

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VisionAire 2 & 3 User Manual — 9

Concentrator Components

Review the gures below and become familiar with

the important parts of your VisionAire 2 or VisionAire 3 Oxygen Concentrator.

Front of Concentrator

Specication Label

Caster(s)

Circuit Breaker Reset Button

Side Handle(s)

Hour Meter

Top Handle

Low Oxygen Concentration Indicator (optional – mandated for EU and specic countries)

Flowmeter Adjustment Knob

Oxygen Outlet

ON/OFF (I/0) Power Switch

Operating Instructions Label

Top and Side Handles: Enables convenience in carrying the unit.

On/Off (I/0) Power Switch: Starts and stops the operation of the unit.

Oxygen Outlet: Provides connection for a humidier

(if required) or cannula.

Circuit Breaker Reset Button: Resets the unit after electrical overload shutdown.

Flowmeter Adjustment Knob: Controls the oxygen

ow rate in liters per minute (LPM).

Low Oxygen Concentration Indicator (optional –

mandated for EU and specic countries): When

equipped with an Oxygen Monitor – a warning LED (amber) is activated on the front panel (see ‘Safety Features’ for details).

Hour Meter: Records the concentrator’s cumulative hours of operation.

Operating Instructions Label: Directs usage of the unit.

Casters: Four casters enable unit to be easily moved, as needed.

Specication Label: Displays electrical specications

and serial number.

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Back of Concentrator

Humidier Bottle Recess

Power Cord

Power Cord: Allows connection of the unit to an electrical outlet.

Humidier Bottle Recess: Area to place the optional humidier bottle.

Humidier Bottle (optional)

Humidier Bottle Fitting

Humidier Bottle

Humidier Bottle (optional): Humidies the oxygen

before it reaches the patient.

Humidier Bottle Oxygen Outlet: Connection for

oxygen tubing/cannula.

Humidier Bottle Oxygen Outlet

Humidier Bottle Tubing

Oxygen Tubing/Cannula

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VisionAire 2 & 3 User Manual — 11

Accessories

Recommended for use with VisionAire 2 and VisionAire 3.

The use of certain administration accessories which

are not specied for use with this concentrator may

reduce performance and void the manufacturer’s warranty.

Item PN

Humidier Bottle HU003-1

Cannula, 25 feet (7.6 m) CU002-4

Cannula, 7 feet (2.1 m) CU002-1

Humidier Bottle Tubing TU176-160

Humidier Bottle Fitting F0655-1

Oxygen Tubing, 25 feet (7.6 m)

CU004-3

Tubing/Cannula Connector CU009-1

OxySafe Kit 20629671

Materials in direct or indirect contact with patient

Item Material

Concentrator Cabinet (all parts)

NOVA PS6201 Super High Impact Polystyrene

Gas Outlet, Nozzle

Aluminum, Black Anodized

On / Off Switch DuPont FR50 Hour Meter Acrylonitrile Butadiene Styrene

(ABS) Plastic & Acrylic Flowmeter ABS (STAT-TECH AS1000) Gas Outlet Brass Circuit Breaker Button - Melamine or Urea

Formaldehyde, Mounting Bushing

– Polyamide 66 (Nylon) Unit Labels Lexan Power Cord Polyvinyl Chloride (PVC), Metal Cord Strain Relief

Nylon

Cord Wrap Velcro Dust Filter Polyester

Humidier Strap Yarn, Rubber Humidier

Bottle

Top – Acrylonitrile Butadiene

Styrene (ABS)

Bottle – Polypropylene (PP)

Diffuser -Polyvinyl Chloride

(PVC) Cannula (Tubing)

Polyvinyl Chloride (PVC)

Safety Features

Part Safety Feature

Compressor Motor

Thermal safety is ensured by a thermostat situated in the stator winding (135°C/ 275 °F). A

safety relief valve is tted to the

compressor outlet and is calibrated to 280 kPa (40 psig).

Power Failure

In the event the unit is operating and a loss of power occurs, an audible single - pulse intermittent alarm will activate.

Oxygen Monitor

The oxygen monitor detects any drop in concentration below 82% (±3%) and activates a visual alarm (amber LED indicator on front panel). If the concentration continues to operate below 82%, an audible 2-pulse intermittent alarm will also activate.

Hi Pressure An over-pressure safety feature

prevents potential damage to device components at a pressure of 207 kPa (30 psig (± 2 psig). An audible 4-pulse intermittent alarm will activate.

Low Pressure

An audible 3-pulse intermittent alarm will activate if the device

pressure reduces to ≤ 35 kPa (5 psig

(± 1 psig).

No Flow Warning

An obstruction to the ow of

oxygen, such as a pinch or kink in the delivery cannula, will activate an audible 6- pulse intermittent alarm.

Product Filter

≥ 10 micron

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Operating Instructions

Review the following information before you operate your oxygen concentrator.

Note: The concentrator releases warm air out the bottom of the unit which can permanently discolor temperature sensitive ooring surfaces such as vinyl. The concentrator should not be used over ooring that is sensitive to heat staining. The manufacturer is not responsible for ooring that becomes discolored.

Humidier Bottle Connection (Optional)

If additional humidication is required with your

oxygen therapy, perform the following steps each time

you ll or clean the humidier, which may have been

initially set up for your use.

1. Remove the humidifier bottle from the humidifier bottle recess.

2. Open the humidifier bottle. If you have a pre-filled bottle, do not perform this step. Proceed to step 5.

3. Fill the humidifier bottle with cool or cold water (distilled water is preferred) to the fill line indicated on the bottle. DO NOT OVERFILL.

4. Re-connect the top cover to the humidifier bottle.

5. Place the humidifier bottle in the humidifier bottle recess on the back of the concentrator and connect the humidifier bottle tubing to the oxygen outlet and the humidifier bottle fitting.

CAUTION: If the humidier bottle tubing is not properly connected to the humidier bottle tting or to the oxygen outlet, an oxygen leak can occur.

Cannula Connection

Connect the tubing and cannula to the unit’s oxygen

outlet, or to the optional humidier’s oxygen outlet.

Starting the Concentrator

WARNING: “NO SMOKING  OXYGEN IN USE” SIGNS MUST BE PROMINENTLY DISPLAYED IN THE HOME, OR WHERE OXYGEN IS IN USE.

PATIENTS AND THEIR CAREGIVERS MUST BE INFORMED ABOUT THE DANGERS OF SMOKING IN THE PRESENCE OF, OR WHILE USING, MEDICAL OXYGEN.

CAUTION: Position the unit away from curtains or drapes, hot air registers or heaters. Be certain

to place the unit on a at surface and make sure all sides are at least 1 foot (30 cm) away from a wall or other obstruction. Do not place the unit in a conned area. Choose a dust and smoke free-location away from direct sunlight. Do not operate the unit outdoors unless the unit is plugged into a Ground Fault Interrupter (GFI) protected outlet.

1. Locate the unit near the electrical outlet in the room where you spend most of your time.

2. Insert the power cord plug into the electrical outlet.

3. Set the I/0 power switch to the “I” position to turn the unit on. An audible alarm will loudly sound for approximately 5 seconds.

4. The low oxygen concentration indicator remains on for a few minutes and until the oxygen concentration reaches minimum concentration requirements, (only pertains to unit equipped with an Oxygen Monitor)

5. To set the flow of supplemental oxygen, turn the flowmeter adjustment knob left or right until the ball inside the flowmeter centers on the flow line number prescribed by your physician. To view the flowmeter at the proper angle, note that the back line and the front number line must give appearance of one line.

6. The concentrator is now ready for use.

Note: Optimal oxygen concentration is obtained within 10 minutes after the device is switched on (90% of the concentration is obtained after approximately 5 minutes).

Page 13

VisionAire 2 & 3 User Manual — 13

CAUTION: It is very important to select only the prescribed level of oxygen. Do not change the ow selection unless you have been directed to do so by a licensed clinician.

Normally, you should not need to adjust the owmeter on your unit. If you turn the owmeter adjustment

knob clockwise, you will decrease and can shut off the

ow of oxygen from your unit.

CAUTION: Ensure concentrator is operated in an upright position.

Turning the Concentrator O

Set the I/0 power switch to the “0” position to turn off the unit.

WARNING: ELECTRICAL SHOCK HAZARD. TURN OFF THE UNIT AND 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.

WARNING: CLEAN THE CABINET, CONTROL PANEL, AND POWER CORD ONLY WITH A MILD HOUSEHOLD CLEANER APPLIED WITH A DAMP CLOTH OR SPONGE, AND THEN WIPE ALL SURFACES DRY. DO NOT ALLOW ANY LIQUID TO GET INSIDE THE DEVICE.

Note: To prevent a voided AirSep warranty, follow all manufacturers’ instructions.

Note: AirSep does not recommend the sterilization of this equipment.

Humidier Bottle (optional)

Check water level daily and add water as needed

To clean and disinfect the humidier, follow your

Equipment Provider’s instructions, or the instructions

included with the humidier bottle.

Outside Cabinet

Use a mild household cleaner applied with a damp cloth or sponge to clean the exterior of the concentrator, and then wipe all surfaces dry. Do not allow any liquids to enter the concentrator.

Care and Cleaning

Page 14

14 — MN165-1 M

If your concentrator fails to operate properly, consult your Equipment Provider, and refer to the troubleshooting

chart on the following pages for probable causes and solutions.

Note: Do not attempt any maintenance other than the possible solutions listed within the manual Note: If the unit has not been used for an extended time period, it needs to operate for several minutes before power failure alarm

can become activated.

Problem Probable Cause Solution

Unit does not operate. Power failure condition causes an alarm to sound.

The power cord is not connected to the electrical outlet.

Check power cord at the electrical outlet for a proper connection.

No power at the electrical outlet.

Check power source, wall switch, in-house fuse or circuit breaker.

Circuit breaker on concentrator unit is activated.

Press (do not hold in) the circuit breaker reset button in the front of the unit.

If the circuit breaker trips again or the alarm continues to sound after the unit is turned on, contact your Equipment Provider.

Limited or no

oxygen ow.

Dirty or obstructed

humidier bottle, or leak

present.

Remove the humidier bottle, and if ow is restored, clean or replace the humidier bottle.

Defective nasal cannula, or other oxygen accessories, i.e. oxygen tubing.

Remove and check accessories for kinks or obstructions. Replace if needed.

Cannula tubing loose. Check cannula tubing connection at control panel.

Condensation collects in the oxygen tubing when you use

a humidier

bottle

Unit not properly ventilated. Elevated operating temperatures.

Make sure unit is positioned away from curtains or drapes, hot air registers or heaters. Be certain to place the unit so all sides are at least 1 foot (30 cm) away from a wall or other

obstruction. Do not place the unit in a conned area. Rell humidier bottle with COLD water.

DO NOT OVERFILL. Allow oxygen tubing to dry out, or replace with new tubing.

Intermittent alarm sounds at one second intervals.

See “Safety Features” for a description of auditory indicators.

Set I/0 power switch to 0 position, use your reserve oxygen supply (if provided), and consult your Equipment Provider immediately.

Oxygen Concentration Indicator remains lit (amber)

Oxygen concentration is ≤

82% (±3%).

Set I/0 power switch to the 0 position, use your reserve oxygen supply (if provided), and consult your Equipment Provider immediately.

All other problems.

Set I/0 power switch to the 0 position, use your reserve oxygen supply (if provided), and consult your Equipment Provider immediately.

Troubleshooting

Page 15

VisionAire 2 & 3 User Manual — 15

For correct use of the device refer to the following chart. The chart provides important information about the recommended operating environments, or operating conditions.

Specications

Flow

Specications

(1)

1/2 lpm – 3 lpm 1/8 lpm – 2 lpm

Oxygen

Concentration

(2)

90% (+ 5.5% / - 3%)

Electrical

Requirements

115 VAC / 60 Hz, 3.0 A 230 VAC / 50 Hz, 1.5 A 230 VAC/ 60 Hz, 1.0 A

Power

Consumption

VisionAire 2 = 200 Watts (+/- 10%) VisionAire 3 = 200 Watts (+/- 10%)

Sound 45 dba anechoic

Dimensions 14.1 in. W x 11.5 in. D x 20.8 in. H

(35.8 cm W x 29.2 cm D x 52.8 cm H)

Weight 30 lbs (13.6 kg)

Electrical Shock

Protection

Class II, Type BF

Environmental

Limit

Conditions

(3)

Operating conditions: 5°C to 40°C (41°F to 104°F) at altitudes up to 10,000 ft. (523 mmHg) above sea level.

Storage: -20°C to 60°C (-4°F to 140°F) Relative Humidity: up to 95% RH

non-condensing

(1) ±10% of indicated setting, or 200 mL, whichever is greater (2) Performance based at 21°C (70°F) at nominal operating pressure range: 0-7 kPa (0-1 psig back pressure). Maximum outlet pressure : 55 kPa. ( 7.98 psig) (3) Operating outside of these operational specications can limit the concentrators ability to meet Oxygen Concentration specication at higher liter ow rates.

Product Specifications

Page 16

16 — MN165-1 M

Medical equipment needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in this section.

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The unit is intended for use in the electromagnetic environment specied below. The customer or the user of the unit should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance

level

Electromagnetic environment – guidance

IEC 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

N/A

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV line(s) to line(s)

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT ) for 0,5 cycle

40 % UT (60 % dip in UT ) for 5 cycles

70 % UT (30 % dip in UT ) for 25 cycles

<5 % UT (>95 % dip in UT ) for 5 sec

<5 % UT (>95 % dip

in UT ) for 0,5 cycle

40 % UT (60 % dip in

UT ) for 5 cycles

70 % UT (30 % dip in

UT ) for 25 cycles

<5 % UT (>95 % dip

in UT ) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the unit requires continued operation during power mains interruptions, it is recommended that the unit be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8

3 A / m 3 A / m

Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE U

is the A.C. mains voltage prior to application of the test level.

Page 17

VisionAire 2 & 3 User Manual — 17

Guidance and Manufacturer’s Declaration–Electromagnetic Immunity

The unit is intended for use in the electromagnetic environment specied below. The customer or the user of the unit should assure that it is used in such an environment.

Immunity test IEC 60601 test

level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80

MHz

3 V/m 80 MHz to 2,5

GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the VisionAire, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Pd 2.1

= 80 MHz to 800 MHz

Pd 2.1

= 800 MHz to 2,5 GHz

Where P is the maximum output power rating of the transmitter in watts (W ) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and

reection from structures, objects and people.

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the VisionAire is used exceeds the applicable RF compliance level above, the VisionAire should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VisionAire.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Page 18

18 — MN165-1 M

Recommended separation distances

between portable and mobile RF communications equipment and the unit

The unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the unit as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

Pd 2.1

80 MHz to 800 MHz

Pd 2.1

800 MHz to 2,5 GHz

Pd 2.1

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and

reection from structures, objects and people.

Guidance and Manufacturer’s Declaration —Electromagnetic Emissions

The unit is intended for use in the electromagnetic environment specied below. The customer or the user of the unit should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions CISPR 11

Group 1

The unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage uctuations/ icker emissions IEC 61000-3-3

Complies

Page 19

VisionAire 2 & 3 User Manual — 19

Method of disposing of waste: All waste from AirSep’s VisionAire 2 and VisionAire 3 Oxygen Concentrator must be disposed of using the

appropriate methods specied by local authorities.

Method for disposing of the device: In order to preserve the environment, the concentrator must be

disposed of using the appropriate methods specied

by local authorities.

AVERTISSEMENT: CET APPAREIL PRODUIT DE L’OXYGÈNE À CONCENTRATION ÉLEVÉE, FAVORISANT UNE COMBUSTION RAPIDE.

NE PAS PERMETTRE DE FUMER OU DES FLAMMES NUES DANS LA MÊME CHAMBRE: 1 CET APPAREIL OU 2 TOUT ACCESSOIRE CONTENANT DE L’OX YGÈNE. NE PAS UTILISER DE PRODUITS À BASE D’HUILE, DE GRAISSE OU DE PÉTROLE SUR OU À PROXIMITÉ DE L’UNITÉ. DÉCONNECTER LE CORDON D’ALIMENTATION DE LA PRISE ÉLECTRIQUE AVANT DE NETTOYER OU DE FAIRE L’ENTRETIEN DE L’UNITÉ.

Disposal

Conformity with EN 60-601 (§ 6.8.2 b) / Classication:

“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, tting, extensions, adjustments, modications 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 specications,

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 MDD (93/42/ EEC:2007/47/EC) Annex I European directive but its operation may be affected by other devices being used close by, such as diathermy and high frequency

electro-surgical equipment, debrillators, 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

specied by the EN 60601-1-2 standard.

Classication

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 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.

Method of cleaning and infection control allowed:

Please refer to your Equipment Provider and the VisionAire Service Manual.

Degree of safety of application in the presence of ammable gases:

Equipment not suitable for such application.

Mode of operation:

Continuous duty.

Page 20

As of the date of this publication, VisionAire, AirSep and their related logos

(as applicable) are trademarks registered by CAIRE Inc.

Lysol

is a registered trademark of Reckitt Benckiser, UK.

OxySafe

is a registered trademark of Applied Home Healthcare Equipment.

Pine-Sol

and Lestoil® are registered trademarks of The Clorox Company.

CAIRE Inc.

2200 Airport Industrial Dr., Ste. 500

Ball Ground, GA 30107

1-800-482-2473

Worldwide: www.chartindustries.com/Respiratory-Healthcare

Medical Product Services GmbH

Borngasse 20

35619 Braunfels, Germany

[email protected]

Worldwide: www.chartindustries.com/Respiratory-Healthcare

|MN165-1_MN~

MN165-1_M

Copyright © 2016 Chart Industries. CAIRE Inc. reserves the right to discontinue its products, or change the prices, materials, equipment, quality, descriptions, specications and/or processes to its products at any time without prior notice and with no further obligation or consequence. All rights not expressly stated herein are reserved by us, as applicable.