AirSep FreeStyle User manual

Patient Manual
AirSep Corporation
401 Creekside Drive
Buffalo, New York 14228 USA
Tel: [phone]
Fax: [phone]
0459

FreeStyle™ EN
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 MAY RESULT.
Smoking while using oxygen is the number one cause of fire
injuries and related d
eaths. You must follow these safety
warnings:
Do not allow smoking, candles, or open flames in the same room
with the device or within 5 feet (1.52 meters) of the oxygen-
carrying accessories.
Smoking while wearing an oxygen cannula may cause facial burns
and possibly death.
Removing the cannula and putting it on bedding, sofas, or other
cushion material will cause a flash fire when exposed to a
cigarette, heat source, or flame.
If you smoke, these 3 steps may save your life:
turn off the oxygen concentrator, take off the cannula, and leave
the room where this device is located.
“No Smoking – Oxygen in Use” signs must be prominently
displayed in the home, or where the oxygen concentrator is in
use. Patients and their caregivers must be informed about the
dangers of smoking in the presence of, or while using, medical
oxygen.

EN FreeStyle™
TABLE OF CONTENTS
AirSep® FreeStyle™ Portable
Oxygen Concentrator
AirSep’s FreeStyle™ Portable Oxygen Concentrator EN1
Symbols EN1-2
Why Your Physician Prescribed Oxygen EN2-3
What is the FreeStyle Portable Oxygen Concentrator? EN3
Operator Profile EN4
FreeStyle for Airline Travel – FAA-Approved EN4
Important Safety Rules EN5-11
Important Safety Rules for Optional AirBelt EN12
Getting Started with Your FreeStyle Portable
Oxygen Concentrator EN13-15
Battery Charging EN15-17
Nasal Cannula EN17-18
FreeStyle Unit Components EN18-19
Operating Instructions EN20-21
Power Supplies EN21-22
FreeStyle™ Universal AC/DC Power Supply
(Instructions for use) EN22-27
Filters EN27-28
Setting of the Flow Selector EN28-29
Alarm/Light Indicators EN29-31
How to Respond to FreeStyle’s Alarm/Light Indicators EN31-32
Cleaning, Care, and Proper Maintenance EN33-35
Cabinet EN33
Filter EN34
Carrying Bag EN35
Alarm/Service Indicator EN35
FreeStyle Accessories EN36-37
Materials in direct or indirect contact with the patient EN38
Reserve Oxygen Supply EN38
Troubleshooting EN38-41
FreeStyle Specifications EN42-45
Classification EN46
Limited Warranty EN47

FreeStyle™ EN
AirSep®Corporation EN-1
MN131-1 rev. B - 02/13
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
Symbol
Description
Warning – Describes
a hazard or unsafe
practice that if not
avoided can result in
severe bodily injury,
death or property
damage
Class II Equipment,
double insulated
Caution – Describes a
hazard or unsafe
practice that can
result in minor bodily
injury or property
damage
Complies with the
93/42/EEC directive
drawn up by the
approved
organization No.
0459
Note – Provides
information important
enough to emphasize
or repeat
See Instructions
Consult the
accompanying
documents
Keep unit and
accessories dry

EN FreeStyle™
EN-2 AirSep®Corporation
MN131-1 rev. B - 02/13
Use no oil or grease
Proper disposal of
waste of electrical
and electronic
equipment required
No Smoking
Do not disassemble
Type BF Equipment
Consult instructions
for use
RTCA/DO-160 Section 21
Category M Compliant
RTCA DO160 Section
21 Category M
Compliant. FAA
SFAR 106
requirement
Safety agency for
CAN/CSA C22.2 No.
60601-1-08 M90 for
medical electrical
equipment
This side up
Safety agency for
CAN/CSA C22.2 No.
601.1 M90 for
medical electrical
equipment
Fragile – handle with
care
FAA Approved –
POC
Do not expose to
open flames
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 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 flow
or setting to address your particular respiratory condition.

FreeStyle™ EN
AirSep®Corporation EN-3
MN131-1 rev. B - 02/13
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.
It is very important to select the prescribed level of oxygen flow.
Do not increase or decrease the flow until you first consult your
physician.
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.)
The FreeStyle Portable Oxygen Concentrator may be used during
sleep under the recommendation of a qualified clinician.

EN FreeStyle™
EN-4 AirSep®Corporation
MN131-1 rev. B - 02/13
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-home 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.
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.

FreeStyle™ EN
AirSep®Corporation EN-5
MN131-1 rev. B - 02/13
----[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.
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.
If you feel discomfort or are experiencing a medical emergency,
seek medical assistance immediately.
Do not heat above 140°F (60°C)
This unit is not to be used for life support. Geriatric, pediatric, or
any other patients unable to communicate discomfort while using
this unit may require additional monitoring. Patients with hearing
and/or sight impairment(s) may need assistance with monitoring
alarms
Use no oil, grease, or petroleum-based or other flammable
products with the oxygen-carrying accessories or the FreeStyle
unit. Only water based, oxygen compatible lotions or salves
should be used. Oxygen accelerates the combustion of
flammable substances.

EN FreeStyle™
EN-6 AirSep®Corporation
MN131-1 rev. B - 02/13
The incorrect use of the FreeStyle battery can cause the battery
to get hot, ignite, and may 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.
While using the FreeStyle outdoors with the Universal AC/DC
power supply, connect the power supply into a Ground Fault
Interrupted (GFI) outlet only.
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 FreeStyle.
No modification of this equipment is allowed.
The FreeStyle 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.
Electrical shock hazard. Disconnect the power cord from the
electrical outlet before you clean the unit to prevent accidental
electrical shock hazard. Only your Equipment Provider or a
qualified service technician should remove the covers or service
the unit.
Care should be taken to prevent FreeStyle from getting wet or
allowing water to enter the unit. This can cause the unit to
malfunction or shut down.

FreeStyle™ EN
AirSep®Corporation EN-7
MN131-1 rev. B - 02/13
Federal (USA) law restricts this device to sale or rental by order
of a physician or other licensed health care provider
In the event of an alarm or you observe that FreeStyle is not
working properly; consult the Troubleshooting section in this
manual. If you cannot resolve the problem, consult your
Equipment Provider.
The FreeStyle Portable Oxygen Concentrator may be used during
sleep under the recommendation of a qualified clinician.
Operating the FreeStyle unit 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.)
Do not allow either the air intake or the air outlet vents to become
blocked. This can cause the FreeStyle unit to overheat and affect
performance.
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 FreeStyle unit to overheat and affect performance.
When using FreeStyle in an automobile, boat, or on other DC
sources with the Universal AC/DC power supply, make sure that
the vehicle is started and running before connecting the
FreeStyle unit. If the Universal AC/DC power supply does not
illuminate and requires resetting, disconnect the power supply
from the DC outlet, restart your vehicle, and then reconnect your
power supply into the DC outlet. Failure to follow these
instructions can result in the power supply not supplying power to
FreeStyle.

EN FreeStyle™
EN-8 AirSep®Corporation
MN131-1 rev. B - 02/13
When the automobile in which you are using the FreeStyle unit is
turned off, disconnect and remove the unit from the automobile
with you. Do not store FreeStyle in a very hot automobile or in
other similar, high-or low-temperature environments. Operating or
storing the unit outside the normal temperature range can affect
the performance of the FreeStyle. (Refer to the Specifications
section in this manual.)
If the FreeStyle 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.)
It is very important to select only the prescribed level of oxygen.
Change the pulse flow selection only under the guidance of your
physician.
Replace the disposable cannula as recommended by the
manufacturer or your equipment provider. Additional supplies are
available from your Equipment Provider.
Do not position the Concentrator so that it is difficult to access the
power cord.
The concentrator should be located as to avoid pollutants or
fumes.
Do not position the Concentrator so that it is difficult to access the
power cord.

FreeStyle™ EN
AirSep®Corporation EN-9
MN131-1 rev. B - 02/13
Portable and mobile RF communications equipment can effect
medical electrical equipment.
Ensure the cannula is fully inserted and secure. This ensures that
the FreeStyle unit can properly detect inspiration for oxygen
delivery.
Storing your FreeStyle for extended periods of time at high
temperatures or with a fully charged or completely discharged
battery can degrade its overall battery life.
Depending upon the temperature of the FreeStyle battery, 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.
The FreeStyle battery does not need to be fully discharged before
recharging. It is recommended to charge the FreeStyle battery
after each use.
Charging 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.
Cannula tubing must be non-kinking, which can be used for a total
length of up to 25 ft (7.6 m) maximum.

EN FreeStyle™
EN-10 AirSep®Corporation
MN131-1 rev. B - 02/13
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.
If the internal battery fully depletes and the FreeStyle unit shuts
down, the unit cannot be restarted with the AirBelt. Should this
occur, connect your FreeStyle to its Universal AC/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.
If the FreeStyle power supply remains connected when the battery
is fully charged, the four LEDs will turn off within approximately 1
hour.
It may be necessary to initially connect the Universal AC/DC
FreeStyle power supply to the FreeStyle unit before the unit will
operate for the first time on battery power. Your Equipment
Provider may have already performed this step for you.
Use only AirSep Part No. FI144-1 for air intake filter for this unit.
Do not operate FreeStyle without the air intake filter in place. If a
second filter is provided, insert the “replacement” filter before you
clean the dirty filter.
AirSep does not recommend the sterilization of this
equipment.

FreeStyle™ EN
AirSep®Corporation EN-11
MN131-1 rev. B - 02/13
Do not attempt any maintenance other than the possible solutions
listed within this manual.
The lithium ion rechargeable battery that is used in the FreeStyle
unit does not need to be fully depleted before recharging. It is
recommended to charge the battery regardless of the battery’s
capacity level after use.
The battery will charge when the unit is off as well as while the unit
is running off the Universal AC/DC power supply.
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 (23 °C) +/- 2°C.
“No Smoking – Oxygen in Use” signs must be prominently
displayed in the home, or where the oxygen concentrator is in use.
Patients and their caregivers must be informed about the dangers
of smoking in the presence of, or while using, medical oxygen.

EN FreeStyle™
EN-12 AirSep®Corporation
MN131-1 rev. B - 02/13
Important Safety Rules for Optional AirBelt
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.
Replace safety cap on AirBelt cord when not in use.
Do not attempt to charge the optional AirBelt with the FreeStyle
Universal AC/DC power supply, or AirBelt can be damaged.
Use only the AirBelt power supply provided to charge AirBelt.
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.
AirBelt does not need to be fully discharged before recharging.
It is recommended to charge AirBelt 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 (23 °C) +/- 2°C.

FreeStyle™ EN
AirSep®Corporation EN-13
MN131-1 rev. B - 02/13
[Read the Important Safety Rules section before operating this equipment.]
Getting Started with Your FreeStyle Portable Oxygen
Concentrator
The FreeStyle packaging contains the following items, as shown in Figures 1-3.
If any are missing, contact your Equipment Provider.
• FreeStyle Portable Oxygen Concentrator with carrying case.
• Patient manual (not shown)
• Universal AC/DC power supply (100-240 volts, 50/60 Hz) with power
cord.
• DC Power Cable
Figure 2: FreeStyle Universal AC/DC Power
Supply/Power Cord
Figure 1: FreeStyle Unit
Figure 3: FreeStyle DC Power
Optionally, you may also have an AirBelt for extended battery duration.
That packaging contains the following, as shown in Figure 4:
• AirBelt battery belt
• Universal AC/DC power supply (100-240 Volt, 50/60 Hz) with power
cord

EN FreeStyle™
EN-14 AirSep®Corporation
MN131-1 rev. B - 02/13
The incorrect use of the AirBelt can cause the battery to get hot,
ignite, and may 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.
All AirBelt Warnings, Cautions and Notes should be read first before
proceeding with your equipment.
See pg 9, “Important Safety Rules for Optional AirBelt”.
Other optional accessories include a harness to easily convert the FreeStyle
carrying bag to a backpack (part number MI284-1), as shown in Figure 5. The
FreeStyle can also be worn on the waist if desired by feeding the AirBelt or other
belt you are wearing through the loops on the FreeStyle carrying case. (See
Figure 6.) The optional accessories bag (part number MI320-1) enables even
more convenient travel when transporting all power accessories and optional
AirBelts and/or the harness for use at your intended destination.
Figure 4: AirBelt and Universal AC/DC
Power Supply/Power Cord
Figure 5: FreeStyle
unit worn backpack
style
Figure 6:
FreeStyle unit
worn on the waist
Replace safety cap on AirBelt cord when not in use.

FreeStyle™ EN
AirSep®Corporation EN-15
MN131-1 rev. B - 02/13
Before operating FreeStyle for the first time, familiarize yourself with the major
components. These are illustrated in the figures on the following pages and
discussed later in the manual.
Battery Charging
Check to make sure your unit’s battery is fully charged before venturing out with
FreeStyle for the first time or upon subsequent use. To check the level of charge
of the internal battery, press the BATT button on FreeStyle’s keypad. The battery
gauge/indicator(s) LEDs above the BATT button illuminate to indicate the level of
internal battery charge (25-100%). Note: The internal battery is charging
whenever the unit is operating on AC or DC power. To charge FreeStyle’s
internal battery, simply connect its Universal AC/DC power supply into the unit’s
power connection inlet (as shown in Figure 7). Be certain to first properly align
the power cord to this inlet. To do this, take note of the “D”-shaped plug of both
the power cord connector and the FreeStyle’s inlet connection. These must be
properly aligned and when removing the power cord, the release button must be
pressed to remove it from the FreeStyle unit. This ensures that neither the unit
nor the power accessories are damaged.
Optional AirBelt
The optional AirBelt, which can increase FreeStyle’s total battery duration up to 10
hours, requires approximately 3 hours to completely charge when the external battery
is fully depleted. To recharge AirBelt, connect its own AC power supply to the end of
AirBelt’s power cord (as shown in Figure 8), and the other end of the power supply
into a proper AC power outlet. A separate battery gauge/indicator for checking the
level of charge on the AirBelt’s battery is located on this accessory’s cord and
functions exactly like the internal battery’s indicator on the keypad.
Depending upon the temperature of the FreeStyle battery, 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.
FreeStyle unit’s
Power Inlet
Press to remove
power cord.

EN FreeStyle™
EN-16 AirSep®Corporation
MN131-1 rev. B - 02/13
The FreeStyle battery does not need to be fully discharged before
recharging. It is recommended to charge the FreeStyle battery
after each use.
Charging 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.
Figure 7: Internal Battery Charging
Figure 8: AirBelt Battery Charging
AirBelt does not need to be fully discharged before recharging. It is
recommended to charge it after each use.
• The FreeStyle’s internal battery will completely recharge from its fully
depleted state in approximately 3 ½ hours, whether or not the unit is in use
on Universal AC/DC power.
• While charging a fully discharged battery, initially the 25% LED will start
blinking rapidly for a few minutes, then start to blink at a slower rate every
(1/2 second).
• The LED will continue to blink until 25% capacity is reached. The LED will
then turn solid.
• Each of the four LEDs, 25% -100%, will blink as stated above, then turn solid
when they reach their capacity.
• When all LEDs illuminate solid, the battery is fully charged and the LEDs will
remain solid for a period of time, then all four LEDs will turn off.

FreeStyle™ EN
AirSep®Corporation EN-17
MN131-1 rev. B - 02/13
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 (23° C) +/- 2°C.
---- [Read the Important Safety Rules section before
operating this equipment.]----
Nasal Cannula
A nasal cannula and tubing are used to deliver oxygen from the FreeStyle unit to
the user. The tubing is connected to the unit’s oxygen outlet (See Figure 9).
Figure 9: Connecting Cannula to FreeStyle’s Oxygen Outlet
AirSep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No.
CU002-1. Other lengths of tubing up to 25 ft (7.6 m) maximum, including nasal
cannula, may be used.
Replace the disposable cannula periodically following normal
usage. Additional supplies are available from your Equipment
Provider.
Cannula tubing must be non-kinking, which can be used for a
total length of up to 25 ft (7.6 m) maximum.