CAIRE VisionAire 5, VisionAire Series User Manual

VisionAire

TM

Family

VisionAire Family

User Controls & System Status Indicators

ISO 7000; Graphical symbols for use on
equipment—Index and synopsis

Read user’s manual before operation.
Reg. # 1641

Keep away from rain, keep dry. Reg.
# 0626

Name and address of manufacturer.
Reg. # 3082

Caution, consult accompanying docu­ments. Reg. # 0434A

Catalog Number. Reg. # 2493

Serial Number. Reg. # 2498

This way up. Reg. # 0623

Fragile, handle with care. Reg. #
0621

ISO 7010: Graphical symbols—Safety colors
and safety signs—Registered safety signs

The instruction manual must be read.
Reg. # M002

Keep away from open ame, re,

sparks. Open ignition source and
smoking prohibited. Reg. # P003

Do not smoke near unit or while
operating unit. Reg. # P002

Type BF applied part (degree of
protection against electric shock).
Reg. # 5333

Warning. Reg. # W001

Council Directive 93/42/EEC; concerning
medical devices

Authorized representative in the
European Community
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices. It bears
the CE marking as shown.

Internal Symbols

Keep away from ammable materials,

oil and grease.

Safety agency for CAN/CSA
C22.2 No. 60601-1-14 for medical

electrical equipment. Certied for

both the U.S. and Canadian markets,
to the applicable U.S. and Canadian
standards.

Do not disassemble.

When present on the device alarm
panel indicates external power inter­ruption has been detected.

2018 Labeling: When present on the
device alarm panel indicates low ox­ygen concentration in device output.

ON (power switch on)

OFF (power switch off)

Date of Manufacture

Class II equipment

21 CFR 801.15: Code of Federal Regulations
Title 21

Federal law restricts this device to
sale by or on the order of a physician.

IEC 60601-1: Medical electrical equipment Part
1 General requirements for basic safety and
essential performance

Drip Proof Equipment - IP21

2 - ENG PN MN238-C4 A | User Manual

VisionAire Family

Council Directive 2012/19/EU: waste electrical
and electronic equipment (WEEE)

WEEE

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.
Our products will comply with the
restriction of Hazardous Substances
(RoHS) directive. They will not con­tain more than trace amounts of lead
or other hazardous material content.

This product may be covered by one or more pat­ents, US and international. Please visit our website
below for the listing of applicable patents. Pat.:
patents.gtls.io.

AirSep® VisionAire® Oxygen
Concentrator

This User Manual will acquaint you with CAIRE’s
VisionAire Oxygen Concentrator. 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.

What is the Oxygen
Concentrator

The air we breathe contains approximately 21%
oxygen, 78% nitrogen, and 1% other gasses. In the
VisionAire oxygen concentrator, room air is drawn
into the machine through the air intakes. It then
passes through an adsorbent material called molec­ular sieve. This material separates the oxygen from
the nitrogen and allows only the oxygen to pass

through. The result is a ow of high-concentration

oxygen delivered to the user.

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

PN MN238-C4 A | User Manual ENG - 3

VisionAire Family

Why Your Physician
Prescribed Oxygen

Many people suffer from a variety of heart, lung,

and other respiratory diseases. A signicant number
of these people can benet from supplemental

oxygen therapy at home, when traveling, or while
participating in daily activities away from home.

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 prescribed a

ow or setting to address your particular respiratory

condition.

Although oxygen is a non-addictive drug, unautho­rized oxygen therapy can be dangerous. You must
seek medical advice before you use this oxygen
concentrator. The Equipment Provider who supplies
your oxygen equipment will demonstrate how to set

the prescribed ow rate.

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

Operator Profile

Concentrators are intended to supply supplemental
oxygen to users suffering from discomfort due to

ailments which effect the efciency of one’s lungs

to transfer oxygen in the air to their bloodstream.
Stationary oxygen concentrators (SOCs) do not
store or contain oxygen. They do not need to be re-

lled, and can recharge anywhere AC or DC power.

Oxygen concentrator use requires a physician’s
prescription and is not intended for life support use.

Although oxygen therapy can be prescribed for
users of all ages, the typical oxygen therapy user
is older than 65 years of age and suffers from a
variety of respiratory diseases, including Chronic
Obstructive Pulmonary Disorder (COPD). Users
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, users
are advised to contact their healthcare provider.
Users 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.

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.

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

4 - ENG PN MN238-C4 A | User Manual

Safety Features

The following information will acquaint you with
safety features of the VisionAire Oxygen Concen­trator. Make sure you read and understand all the
information contained in this manual before you
operate your unit. Should you have any questions,
your Equipment Provider will be happy to answer
them for you.

Device warning label and alarm display.

• Compressor Motor: A pressure relief valve is

tted to the compressor outlet and is calibrated to

280 kPa (40 psig). Thermal safety is ensured by
a thermostat situated in the stator winding of the
compressor (135°C / 275 °F).

• General Malfunction: If any of the conditions
listed below occurs, the general malfunction light

) will illuminate and an audible intermittent

(
alarm will activate.

This includes:

• Obstruction to the ow of oxygen such as a

pinch or kink in the delivery cannula, trig­gered by high product tank pressure

• High device product tank pressure condition
of greater than 33psig (±1)

• Low device product tank pressure condition
of less than 5psig (±1)

• High device temperature of greater than
135°C (275 °F), triggered by low product
tank pressure if the thermal switch located
within the compressor trips (shutting down
the compressor)

VisionAire Family

• Oxygen Monitor: The oxygen monitor detects
any drop in concentration below 82%. If this oc­curs the low oxygen concentration warning light
( ) will illuminate. If the low O2 condition
persists, an audible intermittent alarm will also
activate in addition to the alarm light.

• Power Failure: In the event the unit is operating
and a loss of power occurs, the power warning
light (
intermittent alarm will activate. See label image.

• Product Filter: ≥ 10 μm lter

) will illuminate and an audible

PN MN238-C4 A | User Manual ENG - 5

VisionAire Family

Unpacking Your VisionAire

Verify that all of the components listed are included
in the package. If any items are missing, contact
your oxygen provider immediately.

• Stationary Oxygen Concentrator

Getting to Know Your VisionAire Oxygen Concentrator

First, become familiar with the important parts of
your VisionAire Oxygen Concentrator.

A. On/Off (I/0) Power Switch: Starts and stops the

operation of the unit.

B. Circuit Breaker Reset Button: Resets the unit

after electrical overload shutdown

C. Hour Meter: Records the unit’s total hours of

operation.

D. Flowmeter/Adjustment Knob: Controls and

indicates the oxygen ow rate in liters per minute

(lpm).

E. Oxygen Outlet: Provides connection for a

humidier (if required) or cannula.

F. Top and Side Handles: Enables convenience in

carrying the unit.
G. Warning and Alarms Label
H. Specication Label: Displays electrical speci-

cations and serial number.
I. Power Cord: Allows connection of unit into

electrical outlet.
J. Casters: Four casters enable unit to be easily

moved, as needed.

K. Humidier Bottle Recess: Area to place the

optional humidier bottle.
L. Humidier Bottle (optional)
M. Humidier Bottle Oxygen Outlet: Connection

for oxygen tubing/cannula.

N. Humidier Bottle Oxygen Outlet
O. Humidier Bottle Tubing
P. Humidier Bottle Fitting

Q. Oxygen Tubing / Cannula

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.

6 - ENG PN MN238-C4 A | User Manual

VisionAire Family

F

E

C

L

F

D

B

K

A

G

G

J

Figure 1a

I

N

M

H

O

Figure 1b

P

Q

PN MN238-C4 A | User Manual ENG - 7

VisionAire Family

Important!

Safety Instructions are defined as
follows:

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

CAUTION: Important information for
preventing damage to the VisionAire
Family.

Note: Information needing special attention.

Indications for Use

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.

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 USER UNABLE TO COMMUNICATE
DISCOMFORT WHILE USING THIS DEVICE MAY
REQUIRE ADDITIONAL MONITORING. USERS
WITH HEARING AND/OR SIGHT IMPAIRMENT(S)
MAY NEED ASSISTANCE WITH MONITORING
ALARMS. IF YOU FEEL DISCOMFORT OR ARE
EXPERIENCING A MEDICAL EMERGENCY, SEEK
MEDICAL ASSISTANCE IMMEDIATELY.

Contraindications for Use

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 OXYGEN CONCENTRATOR
SERVICED BY A QUALIFIED TECHNICIAN. THE
OXYGEN CONCENTRATOR IS NOT APPROPRIATE
FOR ANY USER WHO WOULD EXPERIENCE AD­VERSE HEALTH CONSEQUENCES AS THE RESULT
OF SUCH TEMPORARY INTERRUPTION.

Safety Guidelines

WARNING: CAREFULLY REVIEW AND
FAMILIARIZE YOURSELF WITH THE
FOLLOWING IMPORTANT SAFETY IN­FORMATION ABOUT THE VISIONAIRE
INTENSITY OXYGEN CONCENTRATOR.

WARNING: DO NOT OPERATE THIS EQUIPMENT
WITHOUT FIRST READING AND UNDERSTAND­ING THIS MANUAL. IF YOU ARE UNABLE TO UN­DERSTAND THE WARNINGS AND INSTRUCTIONS,
CONTACT YOUR EQUIPMENT PROVIDER BEFORE
ATTEMPTING TO USE THIS EQUIPMENT; OTHER­WISE INJURY OR DAMAGE COULD OCCUR.

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 CANNULA 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.

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VisionAire Family

WARNING: IF YOU SMOKE, YOU MUST
ALWAYS FOLLOW THESE THREE (3) IM­PORTANT STEPS FIRST: 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 OXYGEN IS IN USE.
USERS AND THEIR CAREGIVERS MUST BE IN­FORMED ABOUT THE DANGERS OF SMOKING IN
THE PRESENCE OF, OR WHILE USING, MEDICAL
OXYGEN.

WARNING: 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-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.

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 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 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 OXYGEN-CARRYING ACCESSO­RIES OR THE OXYGEN CONCENTRATOR. OXYGEN
ACCELERATES THE COMBUSTION OF FLAMMA­BLE SUBSTANCES. ONLY WATER BASED, OXYGEN
COMPATIBLE LOTIONS OR SALVES SHOULD BE
USED.

WARNING: DO NOT LUBRICATE FITTINGS, CON­NECTIONS, TUBING, OR OTHER ACCESSORIES OF
THE OXYGEN CONCENTRATOR TO AVOID THE
RISK OF FIRE AND BURNS.

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 OIL­BASED 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: 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.

WARNING: THE OXYGEN CONCENTRATOR
SHOULD NOT BE USED ADJACENT TO OR
STACKED WITH OTHER EQUIPMENT. IF ADJACENT
OR STACKED USE IS UNAVOIDABLE, THE DEVICE
SHOULD BE OBSERVED TO VERIFY NORMAL
OPERATION.

WARNING: ALWAYS PLACE OXYGEN SUPPLY
TUBING AND POWER CORDS IN A MANNER
THAT PREVENTS TRIP HAZARD OR POSSIBLE
ACCIDENTAL STRANGULATION.

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.

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VisionAire Family

WARNING: ENVIRONMENTAL CONDI­TIONS CAN AFFECT PERFORMANCE OF
DEVICE. LOCATE IN CLEAN, PEST-FREE
ENVIRONMENT.

WARNING: DEVICE SHOULD ONLY BE OPERAT­ED BY END USERS, TRAINED CARE-GIVERS OR
TRAINED TECHNICIANS. CHILDREN SHOULD NOT
OPERATE DEVICE.

WARNING: TO ENSURE RECEIVING THE
THERAPEUTIC AMOUNT OF OXYGEN DELIVERY
ACCORDING TO YOUR MEDICAL CONDITION THE
VISIONAIRE MUST BE USED WITH THE SPECIFIC
COMBINATION OF PARTS AND ACCESSORIES
THAT ARE IN LINE WITH THE SPECIFICATION
OF THE CONCENTRATOR MANUFACTURER AND
THAT WERE USED WHILE YOUR SETTINGS WERE
DETERMINED.

WARNING: USE OF THIS DEVICE AT AN ALTITUDE,
TEMPERATURE, OR RELATIVE HUMIDITY OUT­SIDE OF THE SPECIFIED VALUES LISTED IN THIS
MANUAL CAN ADVERSELY AFFECT THE FLOW­RATE AND THE OXYGEN CONCENTRATION, AND
CONSEQUENTLY THE QUALITY OF THE THERAPY.

WARNING: THE USE OF SOME OXYGEN ADMIN­ISTRATION ACCESSORIES NOT SPECIFIED FOR
USE WITH THIS OXYGEN CONCENTRATOR MAY
IMPAIR ITS PERFORMANCE. RECOMMENDED
ACCESSORIES ARE REFERENCED WITHIN THIS
MANUAL.

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.

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

CAUTION: Do not position the unit so that it is
difficult 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 flat 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 confined 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 confined space where ventilation can be
limited. This can cause the device to overheat
and affect 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.

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VisionAire Family

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
flow 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 specification 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: If the humidifier bottle tubing is not
properly connected to the humidifier bottle
fitting or to the oxygen outlet, an oxygen leak
can occur.

CAUTION: Normally, you should not need to ad­just the flowmeter on your unit. If you turn the
flowmeter adjustment knob clockwise, you will
decrease and can shut off the flow of oxygen
from your unit. For your convenience, the flow­meter is marked in ½ LPM increments. For units
equipped with the 2 LPM flowmeter option, the
flowmeter is marked in 1/8 LPM increments for
flow settings up to 2 LPM.

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

Ensure the cannula is fully inserted and secure. You
should hear or feel oxygen flow to the prongs of
the nasal cannula. If oxygen does not seem to flow,
first verify that the flow meter ball is registering
a flow. Then, place the tip of the cannula into a
glass of water; if bubbles come out of the cannula,
oxygen is flowing. 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 VisionAire Oxygen Concentrator must be
operated for at least five minutes at 2 LPM before
using the unit.

The VisionAire is appropriate for usage by two
users, provided the combined flow is a minimum of
2 LPM and does not exceed the maximum capacity
of the concentrator.

To Equipment Provider: The following oxygen ad­ministration accessories are recommended for use
with the VisionAire Oxygen Concentrator:

• Humidifier Bottle: Part No. HU003-1

• Nasal Cannula with 7 feet (2.1 m) of tubing (6
LPM max): 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

period of time, it needs to operate for several
minutes before power failure alarm can become
activated.

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

PN MN238-C4 A | User Manual ENG - 11

VisionAire Family

Note: Portable and mobile radio frequency (RF)
communications equipment can effect medical
electrical equipment.

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

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

• Nasal Cannula with 7 feet (2.1 m) of tubing:
CU002-1

• For any additional recommended accessories,
please see the Accessories Catalog (PN ML­LOX0010) available on www.CAIREmedical.com.

A firebreak is required for use with any cannula.

• CAIRE offers the OxySafe™. This is intended to be
used in conjunction with the oxygen concentrator.
The OxySafe™ is a thermal fuse to stop the flow 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.
For proper use of the OxySafe, always refer to the
manufacturer’s instructions (included with each
OxySafe kit).
CAIRE offers an OxySafe™ kit that includes a
cannula headpiece, OxySafe™, and 7’ tubing: PN

20629671.

WARNING: 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’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.

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.

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VisionAire Family

Specifications

VisionAire

Flow Rates* 1 LPM – 5 LPM

±10% of indicated setting, or 200 mL, whichever is greater*

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)
Sound Pressure Level 45 dBa (1 to 5 LPM)
Power Consumption 290 Watts
O2 Concentration 90% (+ 5.5% / - 3%)
Electrical Requirements 115 VAC / 60 Hz, 3.0A

230VAC /50 Hz, 1.5A
230VAC / 60 Hz, 1.5A

Operating Environment* 5° C to 40° C (41° F to 104° F ) at altitudes from up to 10,000 ft (3048

Altitude -1250 to 10,000 ft (-381 to 3048 m) (tested to 700 – 1060 hPa)
Storage Environment -25° C - 70° C (-13°F - 158°F)

* Based on an atmospheric pressure range of 700 hPa to 1060 hPa at 70°F (21°C)

m) above sea level. 15 - 95% relative humidity (non-condensing)

The expected service life of the equipment is a minimum of ve years.

See Technical Manual (PN MN138-1) for Sound Power Level.

WARNING: USE OF THIS DEVICE AT AN ALTITUDE, TEMPERATURE, OR RELATIVE HUMIDITY
OUTSIDE OF THE SPECIFIED VALUES LISTED IN THIS MANUAL CAN ADVERSELY AFFECT THE
FLOWRATE AND THE OXYGEN CONCENTRATION, AND CONSEQUENTLY THE QUALITY OF THE
THERAPY.

WARNING: USE OF THIS DEVICE AT AN ALTITUDE ABOVE 10,000 FT (3048 M) OR OUTSIDE A TEM­PERATURE OF 5° C TO 40° C (41° F TO 104° F ) OR A RELATIVE HUMIDITY ABOVE 95% IS EXPECTED
TO ADVERSELY AFFECT THE FLOWRATE AND THE PERCENTAGE OF OXYGEN AND CONSEQUENTLY THE
QUALITY OF THE THERAPY .

PN MN238-C4 A | User Manual ENG - 13

VisionAire Family

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 flooring surfaces such as
vinyl. The concentrator should not be used over
flooring that is sensitive to heat staining. The
Manufacturer is not responsible for flooring that
becomes discolored.

Humidifier Bottle (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 humidier bottle from the humidi­er bottle recess.

2. Open the humidier bottle. If you have a pre­lled bottle, do not perform this step. Proceed to

step 5.

3. Fill the humidier bottle with cool or cold water
(distilled water is preferred) to the ll line indi-

cated on the bottle. DO NOT OVERFILL.

4. Re-connect the top cover to the humidier bot­tle.

5. Place the humidier bottle in the humidier

bottle recess on the back of the concentrator

and connect the humidier bottle tubing to the
oxygen outlet and the humidier bottle tting.

CAUTION: If the humidifier bottle
tubing is not properly connected to
the humidifier bottle fitting 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.

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

Ensure the cannula is fully inserted and secure. You
should hear or feel oxygen flow to the prongs of
the nasal cannula. If oxygen does not seem to flow,
first verify that the flowmeter ball is registering
a flow. Then, place the tip of the cannula into a
glass of water; if bubbles come out of the cannula,
oxygen is flowing. If bubbles do not appear, refer to
the troubleshooting section of this manual.

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.

Starting the Concentrator

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

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.

14 - ENG PN MN238-C4 A | User Manual

VisionAire Family

CAUTION: Position the unit away from
curtains or drapes, hot air registers or
heaters. Be certain to place the unit
on a flat 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 confined 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 confined space where ventilation can be
limited. This can cause the device to overheat
and affect 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

CAUTION: Oxygen Concentrator to overheat
and impair performance.

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 ow of supplemental oxygen, turn the
owmeter adjustment knob left or right until the
ball inside the owmeter centers on the ow line

number prescribed by your physician. To view

the owmeter 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.

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
flow 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: Ensure concentrator is operated in an
upright position.

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).

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.

Turning the Concentrator Off

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

PN MN238-C4 A | User Manual ENG - 15

VisionAire Family

Cleaning, Care, and Proper Maintenance

Cabinet

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 OIL, GREASE, OR
PETROLEUM-BASED OR OTHER FLAMMABLE
PRODUCTS WITH THE OXYGEN-CARRYING
ACCESSORIES OR THE OXYGEN CONCENTRATOR.
OXYGEN ACCELERATES THE COMBUSTION OF
FLAMMABLE SUBSTANCES.

WARNING: USE ONLY WATER-BASED LOTIONS
OR SALVES THAT ARE OXYGEN COMPATIBLE
PRIOR TO AND DURING THERAPY. NEVER USE
PETROLEUM OR OIL-BASED LOTIONS OR SALVES
TO AVOID THE RISK OF FIRE AND 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 OIL­BASED 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. 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.

WARNING: CLEAN THE CABINET, CONTROL
PANEL, AND POWER CORD ONLY WITH A MILD
HOUSEHOLD CLEANER APPLIED WITH A DAMP
(NOT WET) CLOTH OR SPONGE, AND THEN
WIPE ALL SURFACES DRY. DO NOT ALLOW ANY
LIQUID TO GET INSIDE THE CONCENTRATOR. PAY
SPECIAL ATTENTION TO THE OXYGEN OUTLET
FOR THE CANNULA CONNECTION TO MAKE
SURE IT REMAINS FREE OF DUST, WATER, AND
PARTICLES.

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 Manufacturer does not recommend the
sterilization of this equipment.

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 liquid to get inside the device. Device cabinet
should be cleaned at a minimum between users.

Humidifier 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 instruc-

tions included with the humidier bottle.

16 - ENG PN MN238-C4 A | User Manual

Alarm Conditions

All alarms are low priority alarms.

Alarm Indicates Action

General malfunction

yellow light
and intermittent
audible alarm

Oxygen monitor
yellow light

and intermittent
audible alarm

Power failure yellow

light
and intermittent
audible alarm

high product tank
pressure

OR
low product tank pressure
OR
high device temperature

low oxygen concentration Contact equipment provider for service.

power failure Ensure device is plugged into a known, working outlet.

Ensure flowmeter is open to minimum flow rate or high­er. Ensure cannula is not kinked or obstructed. Remove
any devices connected downstream of the outlet of the
device. Ensure device has at least 12" of clearance on
all sides and intakes are not obstructed. Ensure external
gross particle intake filter is clean and not clogged. En­sure unit is within operating temperature range. If issue
persists, contact equipment provider for service.

Ensure breaker switch is pushed in. If issue persists
contact equipment provider for service.

VisionAire Family

PN MN238-C4 A | User Manual ENG - 17

VisionAire Family

Troubleshooting

If your VisionAire Oxygen Concentrator fails to operate properly, refer to the chart on the following pages
for possible causes and solutions and, if needed, consult your Equipment Provider.

If you cannot get the unit to operate, connect your nasal cannula, face mask, or other accessories to a
reserve supplemental oxygen supply.

Note: Do not attempt any maintenance other than the possible solutions listed within this manual. Mainte­nance is the responsibility of the provider and will be tracked by the provider.

Note: To prevent a void warranty, follow all manufacturers’ instructions.
Note: If the unit has not been used for an extended time period, it needs to operate for a minimum of 15

minutes before power failure alarm can become activated.

Problem Probable Cause Solution

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

Limited oxygen flow. Dirty or obstructed humidifi-

Condensation collects in the
oxygen tubing when you
use the humidifier bottle.

Intermittent alarm sounds. See ‘Safety Features’ section

Power cord not connected
into electrical outlet.

No power at electrical outlet. Check power source, wall switch, fuse, or

Oxygen concentrator circuit
breaker is activated.

er bottle.

Defective nasal cannula,
face mask, catheter, and/
or oxygen delivery tube, or
other accessory.

Cannula tubing loose. Check cannula tubing connection at control

Unit not properly venti­lated. Elevated operating
temperature.

for a description of auditory
indicators.

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

circuit breaker in-house.
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.

Remove the humidifier bottle from the oxygen
outlet. If flow is restored, clean or replace with
a new humidifier bottle.

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

panel.
Make sure unit is positioned away from

curtains or drapes, hot air registers, heaters,
and fireplaces. Be certain to place the unit so
all sides are at least 12 inches (30.5 cm) away
from a wall or other obstruction. Do not place
the unit in a confined area.

Refill humidifier bottle with COLD water.
DO NOT OVERFILL. Allow oxygen tubing to dry

out, or replace with new tubing.
Set I/0 power switch to 0 position, use your

reserve oxygen supply and consult your Equip­ment Provider immediately.

18 - ENG PN MN238-C4 A | User Manual

VisionAire Family

Problem Probable Cause Solution

Oxygen monitor light
remains lit (yellow).

All other problems. Set I/0 power switch to the 0 position, use

Accessories

Oxygen concentration is ≤
82%.

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

your reserve oxygen supply and consult your
Equipment Provider immediately.

For proper performance and safety, use only these
listed accessories supplied by CAIRE through
your oxygen provider. Use of accessories not listed
below could adversely affect the performance and/
or safety of the concentrator.

VisionAire Family Standard Accessories

Humidifier Bottle
(6–15 LPM)

Cannula, 25 feet
(7.6 m) (6 LPM max)

Humidifier Bottle
Tubing

Humidifier Bottle
Fitting

Part Number – HU003-1

Part Number – CU002-4

Part Number – TU255-1

Part Number – F0655-1

Oxygen Tubing, 25
feet

Tubing/Cannula
Connector

OxySafe Kit (Flow 25
LPM max. Pressure
87 PSIG max.)

Note: Additional options may be available for coun­try-specific power cords where noted above. Contact
CAIRE or your oxygen provider if alternate options
are needed for order.

Part Number – CU004-3

Part Number – CU009-1

Part Number – 20629671

PN MN238-C4 A | User Manual ENG - 19

VisionAire Family

Pd 2.1

Pd 2.1

Pd 2.1

EMC Testing

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

Guidance and Manufacturer’s Declaration —Electromagnetic Emissions

The VisionAire is intended for use in the electromagnetic environment specified below. The customer or the
user of the VisionAire should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions
CISPR 11

RF emissions
CISPR 11
Harmonic emissions

IEC 61000-3-2
Voltage fluctuations/

flicker emissions
IEC 61000-3-3

Group 1

Class B

Complies

Complies

Recommended separation distances between portable and mobile RF
communications equipment and the VisionAire Units

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

Rated maximum
output power of

transmitter

from 150 kHz to 80 MHz

Separation distance according to frequency of transmitter

The VisionAire 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.

The VisionAire 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.

m

from 80 MHz to 800 MHz

from 800 MHz to 2,5 GHz

W

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 affected by absorption

and reflection from structures, objects and people.

20 - ENG PN MN238-C4 A | User Manual

VisionAire Family

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The VisionAire is intended for use in the electromagnetic environment specified below. The customer or the
user of the VisionAire should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment –

Electromagnetic
environment –
guidance

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4

Surge
IEC 61000-4-5

±2 kV for power supply
lines

±1 kV for input/output
lines

±1 kV line(s) to line(s)

±2 kV line(s) to earth

<5 % U

T

(>95 % dip in U

T

for 0,5 cycle

±2 kV for power
supply lines

N/A

±1 kV line(s) to
line(s)

±2 kV line(s) to earth
<5 % U

(>95 % dip in U

)

for 0,5 cycle

T

guidance

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

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

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

)

T

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

40 % U

T

(60 % dip in U
for 5 cycles

70 % U

T

(30 % dip in U
for 25 cycles

<5 % U

T

(>95 % dip in U
for 5 sec

)

T

)

T

T

)

40 % U
(60 % dip in U
for 5 cycles

70 % U
(30 % dip in U
for 25 cycles

<5 % U
(>95 % dip in U
for 5 sec

Power frequency
magnetic field IEC

3 A / m 3 A / m

61000-4-8

NOTE U

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

T

T

Mains power quality should be that of

)

a typical commercial or hospital envi-

T

ronment. If the user of the VisionAire
requires continued operation during

T

T

power mains interruptions, it is recom­mended that the VisionAire is powered
from an uninterruptible power supply

)

T

(UPS).

)

T

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

PN MN238-C4 A | User Manual ENG - 21

VisionAire Family

Pd 2.1

Pd 2.1

Pd 2.1

Guidance and Manufacturer’s Declaration–Electromagnetic Immunity

The VisionAire is intended for use in the electromagnetic environment specified below. The customer or the user
of the VisionAire should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment –

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

guidance

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

= 80 MHz to 800 MHz

= 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 fixed 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 affected by absorption

and reflection from structures, objects and people.

a

Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field 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.

b

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

22 - ENG PN MN238-C4 A | User Manual

VisionAire Family

Method of Disposal

Disposal of Waste

All waste from CAIRE’s VisionAire Oxygen Con­centrator must be disposed using the appropriate

methods specied by local authorities

Disposal of Device

In order to preserve the environment, the concentra­tor must be disposed using the appropriate methods

specied by local authorities.

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 BF Equipment providing a particular
degree of protection against electric
shock 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 – IP21
Protection against ingress of solid foreign
objects greater than 12.5 mm diameter.
Equipment provided with an enclosure
preventing 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 Maintenance section in the
VisionAire Service Manuals.

Degree of safety of application in the presence of

ammable anesthetic gases:

Equipment not suited for such application.

Mode of operation:
Continuous duty.

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 manufacturer does not recommend the
sterilization of this equipment.

PN MN238-C4 A | User Manual ENG - 23

VisionAire Family

Commandes d’utilisation et indicateurs d’état du système

ISO 7000 : symboles graphiques à utiliser sur
l’équipement – index et sommaire

Lire le manuel d’utilisation avant la
mise en marche. Reg. # 1641

Maintenir à l’abri de l’humidité et au
sec. Reg. # 0626

Nom et adresse du fabricant.
Reg. # 3082

Attention, consulter la documentation

ISO 7010 : symboles graphiques – couleurs de
sécurité et étiquettes de sécurité – étiquettes de
sécurité enregistrées

Directive du Conseil européen 93/42/CEE relative
aux dispositifs médicaux

fournie. Reg. # 0434A

Référence catalogue. Reg. # 2493

Numéro de série. Reg. # 2498

Haut. Reg. # 0623

Fragile, manipuler avec soin.
Reg. # 0621

Le manuel d’instruction doit être lu.
Reg. # M002

Tenir à l’écart des ammes nues, du feu,

des étincelles. Source d’incendie ouverte
interdite et interdiction de fumer.
Reg. # P003

Ne pas fumer à proximité de l’appareil
ou pendant son fonctionnement.
Reg. # P002

Pièce appliquée de type BF (degré de
protection contre les chocs électriques).
Reg. # 5333

Avertissement. Reg. # W001

Représentant agréé au sein de l’Union
européenne
Cet appareil est conforme aux exigences
de la Directive 93/42/CEE relative
aux dispositifs médicaux. Il porte le
marquage CE, comme illustré.

Symboles internes

Tenir éloigné des matériaux, huiles et

graisses inammables.

Agence de sécurité pour CAN/
CSA C22.2 no 60601-1-14 pour les

appareils électromédicaux. Certié

pour les marchés des États-Unis et du
Canada, conformément aux normes des
États-Unis et du Canada en vigueur.

Ne pas démonter.

Si présent sur le panneau d’alarme de
l’appareil, indique qu’une interruption
de l’alimentation externe a été détectée.

Étiquetage 2018 : si présent sur le
panneau d’alarme de l’appareil,
indique une faible concentration
d’oxygène dans la sortie de l’appareil.

ON (mise en marche de l’interrupteur)

ON (mise en arrêt de l’interrupteur)

Date de fabrication

Équipement de Classe II

21 CFR 801.15 : Code de la réglementation
fédérale, chapitre 21

La loi fédérale restreint cet appareil à
la vente par, ou sur ordonnance d’un
médecin.

CEI 60601-1 : Appareil électro-médical –
Partie 1 – Règles générales de sécurité de base et
performances essentielles.

Équipement protégé contre les gouttes
d’eau - IP21

24 - FRE PN MN238-C4 A | Manuel d’utilisation

VisionAire Family

Directive du Conseil européen 2012/19/UE :
déchets d’équipements électriques et
électroniques (DEEE)

DEEE

Ce symbole a pour objet d’inciter
le propriétaire de l’équipement à le
retourner à un centre de recyclage à la

n de son cycle de vie, conformément

à la directive relative aux déchets
d’équipements électriques et
électroniques (DEEE).
Nos produits sont conformes à
la Directive sur la limitation des
substances dangereuses (RoHS). Ils ne
contiendront pas plus qu’une quantité

inme de plomb ou d’autres substances

dangereuses.

Ce produit peut être protégé par un ou plusieurs
brevets, américains ou internationaux. Consultez notre
site Web ci-dessous pour voir la liste des brevets.
Brev. : patents.gtls.io.

Concentrateur d’oxygène
AirSep® VisionAire

Ce manuel d’utilisation a pour objet de vous
familiariser avec votre concentrateur d’oxygène
VisionAire de CAIRE. Assurez-vous d’avoir lu et
compris toutes les informations incluses dans ce
guide avant d’utiliser votre concentrateur. Pour toute
question, contactez le fournisseur de l’appareil.

®

Qu’est-ce que le concentrateur
d’oxygène ?

L’air que nous respirons contient environ 21 %
d’oxygène, 78 % d’azote et 1 % d’autres gaz. Avec le
concentrateur d’oxygène VisionAire, l’air de la pièce
est aspiré dans la machine par les admissions d’air.
Il passe ensuite au travers d’un matériau absorbant
appelé tamis moléculaire, qui sépare l’oxygène de
l’azote et capture ce dernier pour laisser uniquement
passer l’oxygène. Le résultat ? Un débit d’une forte
concentration d’oxygène transmis à l’utilisateur.

Remarque : l’utilisation du concentrateur d’oxygène ne
risque en aucun cas d’épuiser tout l’oxygène de la pièce.

PN MN238-C4 A | Manuel d’utilisation 25 - FRE

VisionAire Family

Pourquoi votre médecin vous
prescrit-il de l’oxygène ?

Nombre d’individus souffrent de différentes maladies
cardiaques, pulmonaires ou encore respiratoires.

La majorité d’entre eux peuvent bénécier d’une

oxygénothérapie complémentaire à la maison,
lorsqu’ils voyagent, ou même lorsqu’ils participent à
des activités à l’extérieur.

L’oxygène est un gaz qui constitue 21 % de l’air que
nous respirons. Pour fonctionner correctement, notre
corps a besoin d’un apport régulier. Votre médecin

vous a recommandé un débit ou un réglage à dénir
an de traiter votre affection respiratoire.

Bien que l’oxygène ne constitue en aucun cas
une drogue provoquant un état de dépendance,
une oxygénothérapie non autorisée peut s’avérer
dangereuse. N’oubliez pas de demander conseil à votre
médecin avant d’utiliser ce concentrateur d’oxygène.
Le fournisseur de cet appareil vous montrera comment
régler le débit prescrit.

AVERTISSEMENT : DES INDICATIONS
« INTERDICTION DE FUMER ­UTILISATION D’OXYGÈNE » DOIVENT
ÊTRE AFFICHÉES DE FAÇON BIEN VISIBLE
À VOTRE DOMICILE OU DANS TOUT
LIEU OÙ DE L’OXYGÈNE EST UTILISÉ.
LES UTILISATEURS ET LE PERSONNEL
SOIGNANT DOIVENT ÊTRE INFORMÉS
DES DANGERS LIÉS AU FAIT DE
FUMER EN PRÉSENCE OU PENDANT
L’UTILISATION D’OXYGÈNE MÉDICAL.

Profil de l’utilisateur

Les concentrateurs visent à fournir un apport
d’oxygène supplémentaire aux utilisateurs pris d’un
malaise découlant d’une maladie qui réduit la capacité
des poumons à distribuer l’oxygène contenu dans
l’air dans la circulation sanguine. Les concentrateurs
d’oxygène stationnaires (COS) ne contiennent pas
d’oxygène. Ils ne doivent donc pas être remplis et
peuvent être rechargés partout où une alimentation CA
ou CC est disponible. L’usage d’un concentrateur
requiert une prescription médicale et n’est pas destiné

à des ns de réanimation.

Bien qu’une oxygénothérapie puisse être prescrite aux
utilisateurs de tout âge, les patients sont généralement
âgés de plus de 65 ans et souffrent de différentes
pathologies respiratoires, notamment la maladie
pulmonaire obstructive chronique (MPOC). En règle
générale, les utilisateurs sont dotés de capacités

intellectuelles sufsantes pour exprimer leur malaise.

Dans le cas contraire, ou lorsque l’utilisateur est
incapable de lire et de comprendre les étiquettes
apposées sur le concentrateur ou encore le mode
d’emploi, le concentrateur peut uniquement être
utilisé sous la supervision d’une personne compétente.
Si une gêne est ressentie pendant l’utilisation du
concentrateur, il est conseillé aux utilisateurs de
contacter leur prestataire de soins. Il est également
recommandé aux utilisateurs d’être équipés d’un
apport d’oxygène de secours, tel qu’une bouteille
d’oxygène, dans le cas d’une coupure électrique
ou d’une panne du concentrateur. L’utilisation
du concentrateur n’exige aucune compétence ni
connaissance particulière.

MISE EN GARDE : le fabricant
recommande de disposer d’une autre
source d’alimentation en oxygène
en cas de coupure de courant, de
déclenchement d’alarme de l’appareil
ou de panne mécanique. Consultez
votre médecin ou votre fournisseur
agréé au sujet du type de système de
réserve à utiliser.

Il est très important de sélectionner le débit
d’oxygène qui vous a été prescrit. Ne modifiez pas
le réglage de débit sans sans avis médical.

Le concentrateur d’oxygène peut être utilisé
pendant le sommeil du patient sous la
recommandation d’un clinicien agréé.

26 - FRE PN MN238-C4 A | Manuel d’utilisation

Dispositifs de sécurité

Les informations suivantes ont pour objet de vous
familiariser avec les dispositifs de sécurité du
concentrateur d’oxygène VisionAire. Assurez-vous
d’avoir lu et compris toutes les informations incluses
dans ce manuel avant d’utiliser votre appareil. Pour
toute question, contactez le fournisseur de l’appareil.

Étiquette d’avertissement de l’appareil et voyant d’alarme.

• Moteur du compresseur : la sortie du compresseur
dispose d’une soupape de décompression calibrée à
280 kPa (40 psig). La sécurité thermique est assurée
par un thermostat situé dans le bobinage du stator du
compresseur (135 °C / 275 °F).

• Dysfonctionnement général : si l’une des conditions
indiquées ci-dessous se produit, le témoin de
dysfonctionnement général (
alarme sonore intermittente s’activera.

Cela comprend :

• une obstruction du débit d’oxygène comme
un pincement ou un pli dans la canule de
distribution, déclenchée par une pression élevée
dans le réservoir de produit ;

• condition de pression élevée dans le réservoir
de produit de l’appareil supérieure à 227 Kpa
(33 psig) (±1) ;

• condition de pression faible dans le réservoir
de produit de l’appareil inférieure à 34 Kpa
(5 psig) (±1) ;

• température élevée de l’appareil supérieure
à 135° C (275° F), déclenchée par une
pression faible dans le réservoir de produit
si l’interrupteur thermique situé dans le
compresseur se déclenche (coupant ainsi le
compresseur).

) s’allumera et une

VisionAire Family

• Moniteur d’oxygène : le moniteur d’oxygène détecte
toute chute de concentration en dessous de 82 %. Si
cela se produit le témoin d’avertissement de faible
concentration d’oxygène (
condition de faible concentration en O2 persiste, une
alarme sonore intermittente s’activera également, en
plus du témoin.

• Panne d’alimentation : dans le cas où une panne de
courant se produit alors que l’appareil est en marche,
le témoin d’avertissement d’alimentation (
s’allumera et une alarme sonore intermittente
s’activera. Voir l’illustration de l’étiquette.

• Filtre de produit : ltre de ≥ 10 μm

) s’allumera. Si la

)

PN MN238-C4 A | Manuel d’utilisation 27 - FRE

VisionAire Family

Déballage de votre VisionAire

Vériez que tous les composants indiqués sont inclus

dans l’emballage. En l’absence d’un composant,
contactez immédiatement votre fournisseur d’oxygène.

• Concentrateur d’oxygène stationnaire

Premier contact avec votre concentrateur d’oxygène VisionAire

Tout d’abord, familiarisez-vous avec les parties
importantes de votre concentrateur d’oxygène
VisionAire.

A. Interrupteur marche/arrêt (I/0) : démarre et arrête

l’appareil.

B. Bouton de réinitialisation du disjoncteur :

réinitialise l’appareil après un arrêt en cas de
surcharge électrique

C. Compteur horaire : enregistre le nombre total

d’heures de fonctionnement de l’appareil.

Débitmètre/Bouton de réglage : contrôle et indique le

débit d’oxygène en litres par minute (l/m).

E. Sortie d’oxygène : permet un raccordement pour un

humidicateur (si nécessaire) ou une canule.

F. Poignées supérieures et latérales : permet un

transport pratique de l’appareil.
G. Étiquette d’avertissement et d’alarmes
H. Étiquette des caractéristiques techniques : indique

les caractéristiques électriques et le numéro de série.
I. Cordon d’alimentation : permet le raccordement de

l’appareil à une prise secteur.
J. Roulettes : quatre roulettes permettent de déplacer

facilement l’appareil, au besoin.

K. Logement du acon de l’humidicateur : zone où

poser le acon de l’humidicateur en option.
L. Flacon de l’humidicateur (en option)
M. Sortie d’oxygène du acon de l’humidicateur :

raccordement pour la tubulure/canule d’oxygène.

N. Sortie d’oxygène du acon de l’humidicateur
O. Tubulure du acon de l’humidicateur
P. Raccord du acon de l’humidicateur

Q. Tubulure / canule d’oxygène

AVERTISSEMENT : N’UTILISEZ PAS
DE RALLONGE ÉLECTRIQUE AVEC
CET APPAREIL ET VEILLEZ À NE PAS
BRANCHER UN TROP GRAND NOMBRE
D’APPAREILS SUR LA MÊME PRISE
SECTEUR. L’UTILISATION D’UNE
RALLONGE RISQUE D’AFFECTER LES
PERFORMANCES DE L’APPAREIL. DE
PLUS, SI VOUS EFFECTUEZ TROP DE
BRANCHEMENTS SUR UNE MÊME PRISE,
VOUS RISQUEZ DE PROVOQUER UNE
SURCHARGE DU TABLEAU ÉLECTRIQUE
ET DE DÉCLENCHER LE DISJONCTEUR
OU DE PROVOQUER UN INCENDIE SI
CELUI-CI NE FONCTIONNE PAS.

28 - FRE PN MN238-C4 A | Manuel d’utilisation

VisionAire Family

F

E

C

L

F

D

B

K

A

G

G

J

Illustration 1a

I

N

M

H

O

Illustration 1 b

P

Q

PN MN238-C4 A | Manuel d’utilisation 29 - FRE

VisionAire Family

Important !

Les instructions de sécurité se définissent
comme indiqué ci-dessous :

AVERTISSEMENT : INFORMATIONS
IMPORTANTES DE SÉCURITÉ RELATIVES
AUX DANGERS POUVANT CAUSER DES
BLESSURES GRAVES.

MISE EN GARDE : informations
importantes pour éviter tout
endommagement de la famille
VisionAire.

Remarque : informations exigeant une attention
particulière.

Indications d’utilisation

Contre-indications d’utilisation

AVERTISSEMENT : DANS CERTAINS CAS,
L’UTILISATION D’OXYGÈNE SANS AVIS
MÉDICAL PEUT S’AVÉRER DANGEREUSE.
CET APPAREIL DOIT ÊTRE UTILISÉ
UNIQUEMENT SUR PRESCRIPTION D’UN
MÉDECIN.

AVERTISSEMENT : NE PAS UTILISER CET APPAREIL
EN PRÉSENCE D’ANESTHÉSIQUES INFLAMMABLES.

AVERTISSEMENT : COMME TOUT DISPOSITIF
ÉLECTRIQUE, CET APPAREIL PEUT NE PAS
FONCTIONNER EN RAISON D’UNE COUPURE DE
COURANT OU NÉCESSITER D’ÊTRE RÉPARÉ PAR
UN TECHNICIEN QUALIFIÉ. LE CONCENTRATEUR
D’OXYGÈNE NE PEUT ÊTRE UTILISÉ POUR LES
UTILISATEURS QUI PRÉSENTERAIENT DES
RÉACTIONS INDÉSIRABLES DÉCOULANT D’UNE
INTERRUPTION TEMPORAIRE DE L’APPAREIL.

AVERTISSEMENT : IL EST TRÈS
IMPORTANT DE SÉLECTIONNER LE DÉBIT
D’OXYGÈNE QUI VOUS A ÉTÉ PRESCRIT.
NE MODIFIEZ PAS LE RÉGLAGE DE DÉBIT
SANS AVIS MÉDICAL.

AVERTISSEMENT : CONFORMÉMENT À LA LOI
FÉDÉRALE DES ÉTATS-UNIS, LA VENTE ET LA
LOCATION DE CET APPAREIL DOIVENT SE FAIRE
SUR ORDONNANCE D’UN MÉDECIN OU D’UN
PRESTATAIRE DE SOINS MUNI D’UNE LICENCE.

AVERTISSEMENT : CET APPAREIL NE DOIT PAS ÊTRE
UTILISÉ À DES FINS DE RÉANIMATION. IL PEUT ÊTRE
NÉCESSAIRE DE SURVEILLER LES UTILISATEURS
DES SERVICES GÉRIATRIQUES, PÉDIATRIQUES OU
TOUT AUTRE TYPE D’UTILISATEUR N’ÉTANT PAS
EN MESURE DE COMMUNIQUER UN MALAISE
LORS DE L’UTILISATION DE L’APPAREIL. LES
UTILISATEURS SOUFFRANT DE DÉFICIENCE
AUDITIVE ET/OU VISUELLE PEUVENT AVOIR
BESOIN D’UNE ASSISTANCE POUR SURVEILLER LES
ALARMES. SI VOUS VOUS SENTEZ MAL À L’AISE
OU EN CAS D’URGENCE MÉDICALE, SOLLICITEZ
IMMÉDIATEMENT UNE ASSISTANCE MÉDICALE.

Consignes de sécurité

AVERTISSEMENT : LISEZ ATTENTIVEMENT
ET FAMILIARISEZ-VOUS AVEC LES
INFORMATIONS DE SÉCURITÉ
IMPORTANTES SUIVANTES AU SUJET
DU CONCENTRATEUR D’OXYGÈNE
VISIONAIRE INTENSITY.

AVERTISSEMENT : LISEZ ET ASSUREZ-VOUS D’AVOIR
COMPRIS LES INFORMATIONS DE CE MANUEL
AVANT D’UTILISER CET APPAREIL. SI VOUS NE
COMPRENEZ PAS LES AVERTISSEMENTS ET LES
INSTRUCTIONS, CONTACTEZ VOTRE FOURNISSEUR
AGRÉÉ AVANT D’ESSAYER D’UTILISER L’APPAREIL
AFIN D’ÉVITER TOUT RISQUE DE BLESSURE OU DE
DÉGÂTS MATÉRIELS.

AVERTISSEMENT : FUMER EN UTILISANT DE
L’OXYGÈNE CONSTITUE LA PREMIÈRE CAUSE DE
BLESSURES ET DE DÉCÈS LIÉS AUX INCENDIES.
VOUS DEVEZ IMPÉRATIVEMENT RESPECTER LES
AVERTISSEMENTS DE SÉCURITÉ SUIVANTS :

AVERTISSEMENT : NE LAISSEZ PERSONNE FUMER
ET N’UTILISEZ PAS DE BOUGIES OU DE FLAMMES
NUES DANS LA MÊME PIÈCE QUE L’APPAREIL OU
QUE LES ACCESSOIRES DE TRANSPORT D’OXYGÈNE.

AVERTISSEMENT : FUMER LORS DU PORT D’UNE
CANULE À OXYGÈNE PEUT PROVOQUER DES
BRÛLURES AU VISAGE OU MÊME LA MORT.

AVERTISSEMENT : LE FAIT DE RETIRER LA CANULE
ET DE LA PLACER SUR UN VÊTEMENT, UN DRAP,
UN SOFA OU TOUTE AUTRE MATIÈRE TEXTILE PEUT
PROVOQUER UN EMBRASEMENT INSTANTANÉ
EN CAS D’EXPOSITION À UNE CIGARETTE, À UNE
SOURCE DE CHALEUR, À UNE ÉTINCELLE OU À UNE
FLAMME NUE.

30 - FRE PN MN238-C4 A | Manuel d’utilisation