AirSep MN123-1 F User Manual
Patient Manual
FreeStyle™ Portable
Oxygen Concentrator
260 Creekside Drive
Buffalo, NY 14228-2085 USA
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.
Smoking while using oxygen is the number one cause of fire injuries and related
deaths. You must follow these safety warnings:
Do not allow smoking, candles, or open flames in the same room with 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 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.
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.
“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.
TABLE OF CONTENTS
AirSep® FreeStyle™ Portable
Oxygen Concentrator
AirSep’s FreeStyle™ Portable
Oxygen Concentrator 1
Symbols 1-2
Why Your Physician Prescribed Oxygen 2
What is the FreeStyle Portable
Oxygen Concentrator? 3
Operator Profile 3
FreeStyle for Airline Travel – FAA-Approved 4
Important Safety Rules 5-10
Getting Started with Your
FreeStyle Portable Oxygen Concentrator 11-12
Battery Charging 13-14
Nasal Cannula 15
FreeStyle Unit Components 16
Operating Instructions 17-18
Power Supplies 19-23
Filters 24
Setting of the Flow Selector 25
TABLE OF CONTENTS
AirSep® FreeStyle™ Portable
Oxygen Concentrator
Cabinet 29
Filter 30
Carrying Bag 31
Alarm/Service Indicator 31
Alarm/Light Indicators 26-27
How to Respond to FreeStyle’s Alarm/Light
Indicators 28
Cleaning, Care, and Proper Maintenance 29
FreeStyle Accessories 32
Materials in direct or indirect contact with the patient 33
Reserve Oxygen Supply 33
Troubleshooting 33-35
FreeStyle Specifications 36-39
Classification 40
AirSep’s FreeStyle™ Portable Oxygen Concentrator
This Patient Manual will acquaint you with AirSep’s FreeStyle™ Portable Oxygen Concentrator (POC). Make sure you read and
understand all the information contained in this manual before you operate your FreeStyle unit. Should you have any questions, your
Equipment Provider will be happy to answer them for you.
Symbols
Symbols are frequently used on equipment and/or the manual in preference to words with the intention of decreasing the
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 used with the FreeStyle Portable Oxygen Concentrator.
Symbol Description
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 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
Symbol
Description
Class II Equipment, double insulated
Complies with the 93/42/EEC
directive drawn up by the approved
organization No. 0459
See Instructions
Keep unit and accessories dry
Proper disposal of waste of electrical
and electronic equipment required
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Symbol Description Symbol Description
RTCA/DO-160 Section 21
Category M Compliant
No Smoking
Type BF Equipment
RTCA DO160 Section 21 Category
M Compliant. FAA SFAR 106
requirement
This side up
Fragile – handle with care
Manufacturer
Authorized Representative in the
European Community
Catalog number
Do not disassemble
Consult instructions for use
Safety agency for CAN/CSA C22.2
No. 60601-1-08 M90 for medical
electrical equipment
Safety agency for CAN/CSA C22.2
No. 601.1 M90 for medical electrical
equipment
FAA Approved – POC
Do not expose to open flames
Serial Number
Date of Manufacture
Why Your Physician Prescribed Oxygen
Many people suffer from a variety of heart, lung, and other respiratory diseases. A significant number of these patients can benefit
from supplemental oxygen therapy at home, when traveling, or while participating in daily activities away from hom e.
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 flow 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 flow rate.
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What is the FreeStyle Portable Oxygen Concentrator?
Oxygen concentrators were introduced in the mid-1970’s and has become the most convenient, reliable source of supplemental oxygen
available today. Oxygen concentrators are the most cost-effective, efficient, and safest alternative to using high-pressure oxygen
cylinders or liquid oxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottle deliveries required.
The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gases. In the FreeStyle unit, room air passes
through a regenerative, adsorbent material called “molecular sieve.” This material separates the oxygen from the nitrogen. The result is
a flow of high-concentration oxygen delivered to the patient.
FreeStyle combines advanced oxygen concentrator technology along with oxygen conserving technology for the world’s smallest and
lightest portable oxygen concentrator at just 4.4 lb (2 kg). The FreeStyle efficiently produces its own oxygen, and quickly delivers it as
a pulse of oxygen when you breathe at the very beginning of your inhalation. This eliminates the waste associated with a continuous
flow oxygen device that flows oxygen while you are exhaling. This pulsing of the oxygen is equivalent to continuous flow. FreeStyle
produces the equivalent of up to 3 LPM (liters per minute) in a lightweight package that can be easily carried and used away from the
home.
FreeStyle operates from four different power sources. (Refer to the Power Supplies section of this manual.)
Operator Profile:
AirSep’s Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which
effect the efficiency of ones lungs to transfer the oxygen in air to their bloodstream. POC’s provide the convenience of using a
non-delivery POC system rather than delivery system (O2 tank) which makes the user relatively self-sufficient in terms of in-ho me use,
ambulation (both within and outside of the home) mobility and overall lifestyle. Oxygen Concentrator use requires a physician’s
prescription, and is 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 Disorder (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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FreeStyle for Airline Travel – FAA-Approved
FreeStyle has received the US Federal Aviation Administration’s (FAA) acceptance for onboard in-flight use by oxygen
passengers on commercial airlines via a 2006 amendment to SFAR 106.
In addition, as of May 13, 2009, a new Department of Transporation (DOT)/FAA ruling has determined that US-based carriers,
as well as international flights with origination or destination in the US, must allow passengers with FAA-approved portable
oxygen concentrators to use them on board, and in flight, as medically necessary. Check directly with the individual airlines
with which you would like to travel for up-to-date information on their specific POC policies.
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[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 portable FreeStyle 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 allo w 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 combusti on 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 impairment(s) may need assistance with
monitoring alarms.
Pulse Dose Node settings must be determined for each patient individually for their needs at rest, during exercise, and when
traveling.
If you feel discomfort or are experiencing a medical emergency, seek medical assistance immediately.
Electrical shock hazard. Turn OFF the unit and disconnect the power cord from the electrical 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 and the battery from getting wet or allowing fluids to enter the unit.
This can cause a malfunction or shut down, and cause an increased risk for electrical shock or burns
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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 chlorin e -based products (ethylene chloride), and oil- based products (Pine-Sol®,
Lestoil®). These are NOT to be used to clean the plastic housing on 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 (not wet) cloth or
sponge, and then wipe all surfaces dry. Do not allow any liquid to get inside the device. Pay special attention to the oxygen
outlet for the cannula connection to make sure it remains free of dust, water, and particles.
While using the portable Oxygen Concentrator outdoors with the AC power supply, connect the power supply into a Ground
Fault Interrupted (GFI) outlet only.
Always disconnect AC Power Supply from the wall before disconnecting the AC Power Supply from the oxygen concentrator.
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 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.
Operating outside of the operational specifications can limit the concentrator's ability to meet Oxygen Concentration
specification. Refer to the specifications section of this manual for storage and operating temperature limits.
The incorrect use of the battery can cause the battery to get hot, ignite, and may cause serious injury. Be sure not to pierce,
strike, step on, drop the battery, or otherwise subject the battery to strong impacts or shocks. The use of a damaged battery
may cause personal injury. DO NOT expose the battery to fire or dispose of in a fire. This may cause the battery to explode
and cause potential injury.
DO NOT short-circuit the battery’s metal contacts with metallic objects, such as keys or coins. This may cause sparks or
excessive heat to be generated.
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Contraindications for Use: In certain circumstances, the use of non-prescribed oxygen can be hazardous. This device should
only be used when prescribed by a physician.
NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANETHETICS.
As with any electrically powered device, the user may experience periods of non-operation as a results 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 patient who would experience adverse health consequences as the result of such temporary interruption.
Properly secure, belt or otherwise restrain the oxygen concentrator when in a vehicle during transport to prevent damage or
injury.
If the oxygen concentrator has been dropped, damaged, or exposed to water, please contact your home care provider for
inspection or possible repair of the device. Do not use the oxygen concentrator if it has a damaged power co rd or plug.
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’éq uipement
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 Concentrator so that it is difficult to access the power cord.
The concentrator should be located as to avoid smoke, pollutants or fumes.
Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard.
Do not operate unit in a restricted or confined space (i.e., a small case or handbag) where ventilation can be limited. This can
cause the Oxygen Concentrator to overheat and impair performance.
Do not allow either the air intake or the air outlet vents to become blocked. DO NOT drop or insert any objects into any
openings on the device. This can cause the Oxygen Concentrator to overheat and impair performance.
When using the Oxygen Concentrator in an automobile, boat, or on other DC sources with the DC power supply, make sure
that the vehicle is started and running before connecting the Oxygen Concentrator. If the DC power supply does not illuminate
and requires resetting, disconnect the DC power supply from the DC outlet, restart your vehicle, and then reconnect your DC
power supply into the DC outlet. Failure to follow these instructions can result in the power supply not supplying power to the
Oxygen Concentrator.
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When the automobile in which you are using the Oxygen Concentrator unit is turned off, disconnect and remove the device
from the automobile. Do not store the Oxygen Concentrator in a very hot or cold automobile or in other similar, high-or lowtemperature environments.
DO NOT leave the Oxygen Concentrator or the Power Supply plugged into the vehicle if the ignition is in the OFF position.
Doing so may drain the vehicle’s battery.
The Manufacturer recommends an alternate source of supplement al 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 portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician.
If the Oxygen Concentrator has been stored for an extended period of time outside its normal operating temperature range , the
unit should be allowed to return to normal operating temperature before being turned on. (Refer to the Specifications section in
this manual.)
Operating or storing the Oxygen Concentrator outside of its normal operating temperature range can affect performance and
decrease battery run time and/or increase battery charge time. Refer to the Specifications section in this manual for storage
and operating temperature limits.
For oxygen concentrators equipped with batteries: Store in a cool and dry location to help ensure the longevity of your battery.
Storing your Oxygen Concentrator for extended periods of time at high temperatures or with a fully charged or completely
discharged battery can degrade its overall battery life. Do not attempt to open the battery; there are no serviceable parts inside
the battery. Keep batteries away from children.
ONLY USE the Manufacturer’s provided batteries. For proper battery disposal, contact your Equipment Provider or your local
government agency for disposal requirements.
In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the Troubleshooting section
in this manual. If you cannot resolve the problem, consult your Equipment Provider.
Do not attempt any maintenance other than the possible solutions listed within this manual. DO NOT remove covers, only your
Equipment Provider or a qualified service technician should remove the covers or service this device.
The US Department of Transportation (DOT) and United Nations (UN) Regulations require the removal of the battery from the
device for all international airline travel when the oxygen concentrator is checked as luggage. When shipping the oxygen
concentrator, the battery must also be removed from the device and packaged properly.
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Ensure the cannula is fully inserted and secure. This ensures that the Oxygen Concentrator can properly detect inspiration for
oxygen delivery. During inhalation, you should hear or feel oxygen flow to the prongs of the nasal cannula.
Always follow the cannula manufacturer’s instructions for proper use. Repla ce th e disposable cannula as recommended by the
cannula manufacturer or your Equipment Provider. Additional supplies are available from your Equipment Provider.
Charging of the battery may take several minutes after connecting the power to initiate, depending on the battery’s internal
operating temperature. This is a normal condition and is intended for safe battery charging. This circumstance is more likely
when the battery has been fully discharged.
If the device power supply remains connected when the battery is fully charged, the four LEDs will turn off within approximately
1 hour.
For oxygen concentrators equipped with batteries:
The Oxygen Concentrator battery does not need to be fully discharged before recharging. It is recommended to charge the
Oxygen Concentrator battery after each use.
Lithium batteries may permanently lose capacity when exposed to extremely hot temperatures with the batteries fully charged
or completely depleted. For extended storage, it is recommended that batteries be charged 25 to 50% and remain within a
temperature range of 73°F ± 35°F (23°C ± 2°C).
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:
Nasal Cannula with 7 feet (2.1 m) of tubing: Part No. CU002-1
Use only the manufacturer’s replacement air intake filter: Part No. FI144-1
OxySafe Kit Part No. 20629671
Do not operate the Oxygen Concentrator without the air intake filter in place. If a second filter is provided, insert the
“replacement” filter before you clean the dirty filter. Clean the dirty filter in a warm soap and water solution then dry thoroughly
prior to use.
The Manufacturer does not recommend the sterilization of this equipment.
To prevent a void warranty, follow all manufacturers’ instructions.
Portable and mobile RF communications equipment can effect medical electrica l equipment.
There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit.
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AirSep offers the OxySafe as an optional accessory. This is intended to be used in conjunction with the FreeStyle
concentrator. For customers in regions requiring compliance to EN ISO 8359:1996-Ammendment1:201 2, this accessory will
meet this need.
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).
AirSep offers an OxySafe kit that includes OxySafe with 2” of tubing to connect to the oxygen outlet; PN 20629671
Important Safety Rules for Optional AirBelt
For oxygen concentrators equipped with the optional Airbelt :
1. The incorrect use of AirBelt can cause the battery to get hot, ignite, and can cause serious injury. Be sure
not to pierce, strike, step on, or drop the battery, or otherwise subject the battery to strong impacts or
shocks.
For oxygen concentrators equipped with batteries:
2. Replace safety cap on AirBelt cord when not in use.
1. When connected to AC or DC power, the unit’s battery charges until it reaches full capacity, either while
the unit is operating or turned off.
2. If the internal battery fully depletes and the Oxygen Concentrator shuts down, the unit cannot be restarted
with the optional AirBelt. Should this occur, connect your Oxygen Concentrator to its AC or DC power
supply for a short period of time in order to provide sufficient internal battery power to start the unit.
AirBelt can then be connected to provide additional run time.
For oxygen concentrators equipped with the optional Airbelt:
1. The AirBelt does not need to be fully discharged before recharging. It is recommended to charge it after
each use.
2. Depending upon the temperature of the AirBelt, it can take several minutes for the charging cycle to start
after connecting to power. This is a normal condition and is intended for safe charging.
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