VisionAire
and
VisionAire™3
Oxygen Concentrator
Patient Manual
™
2
[Read the Important Safety Rules section before operating this equipment.]
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 EQUIPMEN; OTHER INJURY
OR DAMAGE COULD OCCUR.
Smoking while using oxygen is the number one cause of
fire, injury, and death. You must follow these safety
warnings:
Do not allow smoking, candles, or open flames within the
same room of the device or the oxygen-carrying accessories.
Smoking while wearing an oxygen cannula can cause facial
burns and possibly result in death.
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.
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.
“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.
Federal (USA) law restricts this device to sale or rental by
order of a physician or other licensed health care provider.
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[Read the Important Safety Rules section before operating this equipment.]
Table of Contents:
Important Safety Rules Page 1-4
Section 1 Introduction Page 6
Why Your Physician Prescribed Oxygen Page 6
What is an Oxygen Concentrator? Page 6
Operator Profile Page 7
Section 2 Concentrator Components Page 8
2.1 Front of Concentrator Page 8-9
2.2 Back of Concentrator Page 10
2.3 Humidifier Bottle Page 11
2.4 Accessories Page 11
2.5 Materials in direct or indirect
contact with the patient Page 12
2.6 Safety Features Page 12
Section 3 How to Operate Your Oxygen Concentrator Page 13
3.1 Humidifier Bottle Connection Page 13
3.2 Cannula Connection Page 13
3.3 Starting the Concentrator Page 13
3.4 Turning the Concentrator Off Page 14
Section 4 Care and Cleaning Page 15
4.1 Humidifier Bottle Page 15
4.2 Outside Cabinet Page 15
Section 5 Troubleshooting Page 16-17
Section 6 Product Specifications Page 18-21
Section 7 Symbols/Abbreviations Page 22
Section 8 Conformity with EN 60-601 (§§ 6.8.2 b): Page 24
Classification
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
ii
[Read the Important Safety Rules section before operating this equipment.]
Important Safety Rules
Carefully review and familiarize yourself with the following important safety information
about the VisionAire™ 2 and VisionAire™ 3 Oxygen Concentrator.
“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.
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.
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.
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.
Use no oil, grease, or petroleum-based or other flammable products with the
oxygen-carrying accessories or the Oxygen Concentrator. Only water based,
oxygen compatible lotions or salves should be used. Oxygen accelerates the
combustion of flammable substances.
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 impairments may
need assistance with monitoring the alarms.
If you feel discomfort or are experiencing a medical emergency, seek medical
assistance immediately.
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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.
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.
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.
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.
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.
No modification of this equipment is permitted.
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.
Use only electrical voltage as specified on the specification label affixed to the
device.
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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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.
Federal (USA) law restricts this device to sale or rental by order of a physician
or other licensed health care provider.
Do not position the unit so that it is difficult to access the power cord.
The concentrator should be located as to avoid smoke, pollutants or fumes.
Ensure concentrator is operated in an upright position.
Always place oxygen supply tubing and power cords in a manner that prevents
a trip hazard.
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.
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.
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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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.
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.
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.
If the audio alarm is weak or does not sound at all, consult your Equipment
Provider immediately.
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.
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 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.
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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.
To Equipment Provider: The following oxygen administration accessories
are recommended for use with the Oxygen Concentrator
• Humidifier Bottle: Part No. HU003-1
• Nasal Cannula with 7 feet (2.1 m) of tubing: Part No. CU002-1
The Manufacturer does not recommend the sterilization of this equipment.
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.
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 five minutes.
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.
To prevent a void warranty, follow all manufacturers’ instructions.
Do not attempt any maintenance other than the possible solutions listed within
the manual.
Portable and mobile RF communications equipment can effect medical
electrical equipment.
There is never a danger of depleting the oxygen in a room when you use your
Oxygen Concentrator unit.
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1.0 Introduction
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
significant number of these patients can benefit 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 flow sufficient 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 flow rate.
What is an Oxygen Concentrator?
Oxygen concentrators were introduced in the mid-1970s 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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Operator Profile:
AirSep’s Stationary Concentrators are intended to supply supplemental Oxygen to users
suffering from discomfort due to ailments which affect the efficiency of ones lungs to
transfer the oxygen in air to their bloodstream. Users can benefit 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.
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Top Handle
EU and specific countries)
Hour Meter
Adjustment
Knob
Side Handle(s)
2.0 Concentrator Components
Review the figures below and become familiar with the important parts of your
VisionAire 2 or VisionAire 3 Oxygen Concentrator.
2.1 Front of Concentrator
Oxygen Outlet
Flowmeter
Low Oxygen
Concentration
Indicator
(optional – mandated for
Circuit Breaker
Reset Button
ON/OFF (I/0)
Power Switch
Operating
Instructions
Label
Figure 1
Caster(s)
Specification
Label
Figure 1a
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Ø Top and Side Handles:
o Enables convenience in carrying the unit.
Ø On/Off (I/0) Power Switch:
o Starts and stops the operation of the unit.
Ø Oxygen Outlet
o Provides connection for a humidifier (if required) or cannula.
Ø Circuit Breaker Reset Button:
o Resets the unit after electrical overload shutdown
Ø Flowmeter Adjustment Knob:
o Controls the oxygen flow rate in liters per minute (LPM).
Ø Low Oxygen Concentration Indicator (optional – mandated for EU and specific countries)
o When equipped with an Oxygen Monitor – a warning LED (amber) is activated
on the front panel (see Section 2.6 ‘ Safety Features’ for details)
Ø Hour Meter:
o Records the concentrator’s cumulative hours of operation.
Ø Operating Instructions Label:
o Directs usage of the unit.
Ø Casters:
o Four casters enable unit to be easily moved, as needed.
Ø Specification Label:
o Displays electrical specifications and serial number.
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2.2 Back of Concentrator
Humidifier
Bottle Recess
Power Cord
Figure 2
Ø Power Cord:
o Allows connection of the unit to an electrical outlet.
Ø Humidifier Bottle Recess:
o Area to place the optional humidifier bottle.
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2.3 Humidifier Bottle (optional)
Humidifier
Bottle Tubing
Ø Humidifier Bottle (optional):
o Humidifies the oxygen before it reaches the patient.
Ø Humidifier Bottle Oxygen Outlet:
o Connection for oxygen tubing/cannula.
2.4 Accessories:
Recommended for use with VisionAire 2 and VisionAire 3.
The use of certain administration accessories which are not specified for use with
this concentrator may reduce performance and void the manufacturer’s warranty.
Ø Humidifier Bottle
o AirSep part number – HU003-1
o
Ø Cannula, 25 feet (7.6 m)
o AirSep part number – CU002-4
o
Ø Humidifier Bottle Tubing
o AirSep part number – TU176-160
o
Ø Humidifier Bottle Fitting
o AirSep part number – F0655-1
o
Ø Oxygen Tubing, 25 feet (7.6 m)
o AirSep part number – CU004-3
Ø Tubing/Cannula Connector
o AirSep part number – CU009-1
Humidifier Bottle
Fitting
Humidifier Bottle
Oxygen Outlet
Humidifier
Bottle
Figure 3
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2.5 Materials in direct or indirect contact with the patient
o Concentrator Cabinet (all parts) …………… NOVA PS6201 Super High Impact Polystyrene
o Gas Outlet, Nozzle ………………………. Aluminum, Black Anodized
o On / Off Switch ……………………….. DuPont FR50
o Hour Meter …………………………......... Acrylonitrile Butadiene Styrene (ABS) Plastic &
Acrylic
o Flowmeter ……………………………….. ABS (STAT-TECH AS1000)
o Gas outlet ……………………………........ Brass
o Circuit Breaker …………………………... Button - Melamine or Urea Formaldehyde,
Mounting Bushing – Polyamide 66 (Nylon)
o Unit Labels ………………………………. Lexan
o Power Cord……………………………….. Polyvinyl Chloride (PVC), Metal
o Cord Strain relief ………………………… Nylon
o Cord Wrap ……………………………….. Velcro
o Dust Filter ………………………………... Polyester
o Humidifier Strap ……………………......... Yarn, Rubber
o Humidifier Bottle ………………………... Top – Acrylonitrile Butadiene Styrene (ABS)
………………………… Bottle – Polypropylene (PP), Diffuser -Polyvinyl
Chloride (PVC)
o Cannula (Tubing)………………………… Polyvinyl Chloride (PVC),
2.6 Safety Features:
Ø Compressor Motor: Thermal safety is ensured by a thermostat situated in
the stator winding (135°C/ 275 °F). A safety relief valve is fitted to the
compressor outlet and is calibrated to 280 kPa (40 psig).
Ø Power Failure : In the event the unit is operating and a loss of power occurs,
an audible single - pulse intermittent alarm will activate.
Ø 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.
Ø 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.
Ø Low Pressure: An audible 3- pulse intermittent alarm will activate if the
device pressure reduces to ≤ 35 kPa (5 psig (± 1 psig)).
Ø No Flow Warning : An obstruction to the flow of oxygen, such as a pinch or
kink in the delivery cannula, will activate an audible 6- pulse intermittent
alarm.
Ø Product Filter: ≥ 10 micron
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The concentrator releases warm air out the bottom of the unit which can
discolored.
3.0 How To Operate Your Oxygen Concentrator
Review the following information before you operate your oxygen concentrator.
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
3.1 Humidifier Bottle Connection
(Optional)
If additional humidification is required with your oxygen therapy, perform the
following steps each time you fill or clean the humidifier, 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.
If the humidifier bottle tubing is not properly connected to the humidifier
bottle fitting or to the oxygen outlet, an oxygen leak can occur.
3.2 Cannula Connection
Connect the tubing and cannula to the unit’s oxygen outlet, or to the optional
humidifier’s oxygen outlet.
3.3 Starting the Concentrator
“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.
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.
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 (GFCI) protected outlet.
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It is very important to select only the prescribed level of oxygen
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.
Optimal oxygen concentration is obtained within 10 minutes after the device is
switched on (90% of the concentration is obtained after approximately 5
minutes).
. Do not
change the flow selection unless you have been directed to do so by a licensed
clinician.
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.
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.
Ensure concentrator is operated in an upright position.
3.4 Turning the Concentrator Off
• Set the I/0 power switch to the “0” position to turn off the unit.
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Electrical shock hazard
4.0 Care and Cleaning
from the electric outlet before you clean the unit to prevent accidental electrical
shock and burn hazard. Only your Equipment Provider or a qualified
service technician should remove the covers or service the unit.
Care should be taken to prevent the 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.
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 unit, 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 or sponge, and then wipe all surfaces dry.
Do not allow any liquid to get inside the device.
. Turn Off the unit and disconnect the power cord
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.
To prevent a voided AirSep warranty, follow all manufacturers’ instructions.
AirSep does not recommend the sterilization of this equipment.
4.1 Humidifier Bottle (optional)
• Check water level daily and add water as needed
• To clean and disinfect the humidifier, follow your Equipment Provider’s
instructions, or the instructions included with the humidifier bottle.
4.2 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.
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.
5.0 Troubleshooting
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.
Do not attempt any maintenance other than the possible solutions
listed within the manual
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
Unit does not
operate. Power
failure condition
causes an
alarm to sound.
The power cord is not
connected to the electrical
outlet.
No power at the electrical
outlet.
Circuit breaker on
concentrator unit is
activated.
Limited or no
oxygen flow.
Dirty or obstructed
humidifier bottle, or leak
present.
Defective nasal cannula,
or other oxygen
accessories, i.e. oxygen
tubing.
Cannula tubing loose
Solution
Check power cord at the electrical
outlet for a proper connection.
Check power source, wall switch, inhouse fuse or circuit breaker.
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, and if
flow is restored, clean or replace the
humidifier bottle.
Remove and check accessories for
kinks or obstructions. Replace if
needed.
Check cannula tubing
connection at control panel.
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Problem Probable Cause Solution
Condensation
collects in the
oxygen tubing
when you use
a humidifier bottle
Intermittent alarm
sounds at one
second intervals.
All other problems.
Oxygen
Concentration
Indicator remains
lit (amber)
Unit not properly
ventilated.
Elevated operating
temperatures.
See section 2.6
‘Safety Features’ for
a description of
auditory indicators.
Oxygen
concentration is
≤ 82% (±3%).
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 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 (if provided), and
consult your Equipment Provider
immediately.
Set I/0 power switch to the 0 position, use
your reserve oxygen supply (if provided),
and consult your Equipment Provider
immediately.
Set I/0 power switch to the 0 position, use
your reserve oxygen supply (if provided),
and consult your Equipment Provider
immediately.
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7 kPa
6.0 PRODUCT SPECIFICATIONS
VisionAire™ 2 and VisionAire™3
Flow Specifications
(1)
±10% of indicated setting, or 200 mL, whichever is greater
½ lpm – 3 lpm
⅛ lpm – 2 lpm
(1)
Oxygen Concentration
(1)
90% (+ 5.5% / - 3%)
Electrical Requirements
115 VAC / 60 Hz, 3.0 A
230 VAC / 50 Hz, 1.5 A
230 VAC/ 60 Hz, 1.5 A
Power Consumption
VisionAire 2 = 200 Watts (+/- 10%)
VisionAire 3 = 175 Watts (+/- 10%)
Sound
40 dba
Dimensions
Weight
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)
30 lbs (13.6 kg)
Electrical Shock
Protection
Class II, Type B
Operating conditions: 5 oC to 40 oC (41 oF to 105 oF ) at
Environmental Limit
Conditions
(1) Performance based at 21°C (70°F) at nominal operating pressure range: 0-
(0-1 psig backpressure). Maximum outlet pressure : 55 kPa. ( 7.98 psig)
(2) Operating outside of these operational specifications can limit the concentrators ability
to meet Oxygen Concentration specification at higher liter flow rates.
(2)
altitudes up to 10,000 ft.(523mmHg) above sea level.
Storage: -20 oC - 60 oC (-4°F - 140°F)
Relative Humidity: up to 95% RH non - condensing
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MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
“Specifications continued”
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
The unit is intended for use in the electromagnetic environment specified below. The customer or the user of the unit should assure that it is used
in such an environment.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
manufacturer’s
IEC 60601
test level
6 kV contact
±
8 kV air
±
declaration ± electromagnetic
Compliance level
6 kV contact
±
8 kV air
±
immunity
Electromagnetic environment ±
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30 %.
guidance
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power.
IEC 61000-4-11
Power frequency
magnetic field
IEC 61000-4-8
2 kV for power
±
supply lines
1 kV for input/output
±
lines
1 kV line to
±
2 kV line to earth
±
<5 %
U
T
(>95 % dip in
for 0,5 cycle
40 %
U
T
(60 % dip in
for 5 cycles
70 %
U
T
(30 % dip in
for 25 cycles
<5 %
U
T
(>95 % dip in
for 5s
3 A/m
line
U
U
2 kV for power
±
supply lines
Not Applicable
1 kV line to
±
U
)
T
)
T
)
T
U
)
T
2 kV line to earth
±
<5 %
(>95 % dip in
for 0,5 cycle
40 %
(60 % dip in
for 5 cycles
70 %
(30 % dip in
for 25 cycles
<5 %
(>95 % dip in
for 5 s
3 A/m
line
U
T
U
)
T
U
T
U
)
T
U
T
U
)
T
U
T
U
)
T
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.
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
(UPS) or a battery.
Power frequency magnetic fields 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.
T
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MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
Guidance and
The unit is intended for use in the electromagnetic environment specified below. The customer or the user of the unit should assure that it is used in
such an electromagnetic environment.
IMMUNITY test
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
manufacturer’s
IEC 60601 TEST
LEVEL
declaration ± electromagnetic
Compliance
level
3 Vrms
3 V/m
Electromagnetic environment ± guidance
Portable and mobile RF communications equipment should be used no closer
to any part of the unit including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
D= 1.2 x √P
D= 1.2 x √P from 80MHz to 800MHz
D= 2.3 x √P from 800MHz to 2.5GHz
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 meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site surveya should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following
symbol:
immunity
b
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 unit used exceeds the applicable RF compliance level above, the unit should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the unit.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
20
MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
Recommended separation distances
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
W
Separation distance according to frequency of transmitter
(m)
from 150kHz to 80MHz
d= 1.2 x √P
from 80MHz to 800MHz
d= 1.2 x √P
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 meters (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.
between
from 800MHz to 2.5GHz
d= 2.3 x √P
Guidance and
The unit is intended for use in the electromagnetic environment specified below. The customer or the user of the unit should assure that it is used
in
such an
environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
manufacturer’s
Compliance
Group 1
Class B
Class A
Complies
declaration - electromagnetic
Electromagnetic Environment guidance
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.
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.
emissions
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MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
Symbol
Description
Symbol
Description
7.0 Symbols/Abbreviations
Symbols are frequently used on equipment in preference to words with the intention of
lessening any possibility of misunderstanding caused by language differences. Symbols
can also permit easier comprehension of a concept within a restricted space.
The following table is a list of symbols and definitions that may be used with AirSep’s
VisionAire 2 and VisionAire 3 Oxygen Concentrators. These symbols are referenced
from the appropriate International Electro-technical Commission (IEC) standards:
ON (power switch on)
No smoking
Type B equipment
Warning – Describes a hazard or
unsafe practice that if not avoided
can result in severe bodily injury,
death or property damage
Caution – Describes a hazard or
unsafe practice that if not avoided
can result in minor bodily injury or
property damage
Note – Provides information
important enough to emphasize
or repeat
Consult the accompanying
documents
Use no oil or grease
Oxygen outlet connection to the
OFF (power switch off)
Do not disassemble
Consult instructions for use
Class II Device
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
Proper disposal of waste of electrical and
electronic equipment required
Do not expose to open flames
cannula
Caution: Federal law (USA)
restricts this for sale or rental by
or on the order of a physician or
licensed health care provider.
Fragile – handle with care
Keep in the vertical position
Oxygen concentration warning LED
See Instructions
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MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
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.
Method for disposing of the device: In order to preserve the environment, the
concentrator must be disposed of using the appropriate methods.
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.
23
MN165-1 Rev G
[Read the Important Safety Rules section before operating this equipment.]
8.0 Conformity with EN 60-601 (§§ 6.8.2 b) / Classification:
“The manufacturer, assembler, installer or importer are not considered to be responsible themselves for the
consequences on the safety, reliability and characteristics of a device unless:
- The assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons
authorized by the party in question,
- The electrical installation of the corresponding premises complies with IEC regulations.
- The device is used in accordance with the instructions for use. “If the replacement parts used for the
periodic servicing by an approved technician do not comply with the manufacturer’s specifications, the
latter is absolved from all responsibility in the event of an accident. Do not open the device while in
operation: risk of electrical shock. This device complies with the requirements of the
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,
defibrillators, short wave therapy equipment, mobile telephones, CB and other portable devices, microwave
ovens, induction plates or even remote control toys and more generally electromagnetic interferences which
exceed the levels specified by the EN 60601-1-2 standard.
Classification
Type of protection against electric shock:
Class II Protection from electric shock is achieved by DOUBLE INSULATION.
Protective earthing or reliance upon installation conditions are not required.
Degree of protection against electric shock:
Type B Equipment providing a particular degree of protection against electric shock, particularly
regarding:
1) Allowable leakage current;
2) Reliability of protective earth connection (if present).
Not intended for direct cardiac application.
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 flammable gases:
Equipment not suitable for such application.
Mode of operation: Continuous duty.
For European Representative:
Gavin Ayling
9 Bungham Lane
Penkridge Stafford
Staffordshire ST19 5NH England
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MN165-1 Rev G
Manufactured by:
AirSep Corporation
Buffalo, NY 14228-2085 USA
|MN165-1_GÆ~
MN165-1 Rev G
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