Freestyle MN126-1 User manual

F r eeS t yle
™
P or table
Oxygen C onc en tra t or
Service M anual

Expedited Product Warranty Check service is available at 800-482-2473
Air Travel with FreeStyle
FreeStyle is approved for use on-board commercial aircraft per an addendum to FAA SFAR
106.

MN126-1 Rev. E

Table of Contents
Section 1.0
I n troduction
Section 2.0
Operation Check and
1.1 E quipmen t Provider R esponsibilit y 1-1
1.2 I mpor tan t Notice and Symbol Explanations 1-2
1.3 Definitions of Symbols 1-3
1.4 FreeStyle Specifications 1-4
1.5 FreeStyle Classifications 1-5
T est of Oxygen C onc en tration
2.1
Description of Oper a tion
2-1
2.2
Operation Check
2-1
2.3
Alarm S y stem
2-2
2.3.1
S tar t -up
2-2
2.3.2
Battery S ta tus
2-2
2.3.3
L o w Ba tt er y
2-2
2.3.4
Discharged Ba tt er y
2-2
2.3.5
Battery Char g ing
2-3
2.3.6
Battery Fully Char ged
2-4
2.3.7
Cannula Disc onnec t
2-4
2.3.8
Performance W ar ning
2-4
2.3.9
FreeStyle Capacity Ex c eeded
2-4
2.3.10
General M alfunc tion
2-4
Section 3.0
Patient I nstructions
2.4 Oxygen C onc en tr a tion T est and Specification 2-5
3.1 General I nstructions 3-1
3.1.1 Connecting t o E x t e r n a l Power 3-1
3.1.2 Optional AirBelt Battery 3-1
3.2 R outine Maintenance by the Patient 3-4
i –table of contents

Section 4.0
E quipmen t P r o vider
M ain t enanc e
3.2.1 Cleaning the Air I n take
GrossParticle Filter 3-4
3.2.2 Alarm/Service I ndica t or 3-5
3.2.3 Nasal Cannula 3-5
3.2.4 Usage During Sleep 3-5
4.1 No Scheduled Maintenance 4-1
4.1.1 Air I n take / GrossParticle Filter
4-1
4.1.2 Product Filter R eplac emen t
4-1
4.1.3 Compressor Servicing
4-2
4.1.4 R ec or ding M ain t enanc e
4-2
4.2
I nf ection C on tr ol
4-2
4.3
Cleaning and Preparing for New Patient Use
4-2
Section 5.0
Service
5.1
C omponents
5-1
5.2
Housing R emo v al
5-2
5.2.1 R emo ving Front Cover
5-2
5.2.2 R emo ving Back Cover
5-2
5.3
I n t er nal Battery R eplac emen t
5-3
5.4
PSA R emo v al
5-4
5.5
Compressor R eplac emen t
5-10
5.5.1 Compressor Assembly R emo v al
5-10
5.5.2 Compressor Assembly I nstalla tion
5-12
5.6
Product Manifold R eplac emen t
5-13
5.7
Solenoid V alv e R eplac emen t
5-14
5.8
Adsorbent B ed R eplac emen t
5-15
5.9
Feed/Waste Manifold R eplac emen t
5-17
5.10
Measuring System P r essur e
5-18
5.11
Hour Meter F unc tionalit y
5-19
5.11.1 Ic ons
5-19
5.11.2 P o w er
5-19
5.11.3 Service LED
5-19
5.11.4 T oggle/R eset S wit ch
5-20
5.12
Hour Meter R eplac emen t
5-20
ii –table of contents

iii –table of contents
iii –table of contents
5.13 Circuit B oar d R eplac emen t 5-21
5.14 Motor Controller B oar d R eplac emen t 5-25
5.15 Control/KeyPanel R eplac emen t 5-27
5.16 Fan R eplac emen t 5-31
Section 6.0
Typical Pressure Profiles
6.1 Pressure Profile Quadrant 6-1
Section 7.0
T r oubleshooting
7.1 General T r oubleshooting 7-1
7.2 T r oubleshooting Chart 7-2
Section 8.0
R ec ommended Tools
8.1 Tools for FreeStyle Service and Maintenance 8-1

FreeStyle Service Manual MN126-1 E
1-1
1.0 Introduction
1.1 Equipment Provider Responsibility
All EquipmentProvidersof the FreeStyle™PortableOxygen Concentrator must
assume responsibilities for handling, operationalcheck-out,patient instruction,and
maintenance. These responsibilities are outlined below and throughoutthis manual.
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.
As an Equipment Provider, you must do all of the following:
■Inspect the condition of each FreeStyle unit immediately upon
delivery to your business location. Note any sign of damage,
external or internal, on the delivery receipt, and report it
directly to both the freight company and AirSep Corporation
immediately.
■Check the operation of each FreeStyle unit before delivery to a
patient. Always operate the unit for a minimum of 10 minutes,
and check that the oxygen concentration level is within
specifications, as described in Section 5 of this manual.
■ Deliver FreeStyle units only to patients authorized by a physician’s
prescription. FreeStyle must not be used as a life-supporting
device.
■Instruct patients how to use FreeStyle in conjunction with the
Patient Manual.
■Instruct patients to notify their physicians and/or Equipment
Providers if they experience any signs of discomfort.
■Instruct each patient to perform routine maintenance of the air intake gross
Filter. (Refer to Section 3.2.)
■Be available to service each patient at any time.
■Maintain FreeStyle in accordance with Section 4.0.
■Repair components and replace parts only as outlined in this
manual. Use only AirSep parts for replacement in FreeStyle Oxygen
Concentrators.

FreeStyle Service Manual MN126-1 E
1-2
1.2 Important Notice and Symbol Explanations
As you review both the FreeStyle Patient Manual and this FreeStyle Service
Manual, pay special attention to the WARNING, CAUTION, and NOTE messages.
They identify safety guidelines or other important information as follows:
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 deaths. 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.
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
“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.

FreeStyle Service Manual MN126-1 E
1-3
1.3 Definitions of 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.
RTCA DO160 Section 21
Category M Compliant. FAA
SFAR 106 requirement
Safety agency for CAN/CSA C22.2 No.
601.1 M90 for medical electrical
equipment
Symbol
Description
Symbol
Description
ON (power switch on)
OFF (power switch off)
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 if not avoided can result in
minor bodily injury or property damage
Safety agency for CAN/CSA C22.2 No.
601.1 M90 for medical electrical
equipment
Note –Provides information important
enough to emphasize or repeat
Keep unit and accessories dry
Consult the accompanying
documents
Proper disposal of waste of electrical and
electronic equipment required
Use no oil or grease
Do not disassemble
No smoking
Consult instructions for use
Type BF equipment
Do not expose to open flames
Oxygen outlet connection to the
cannula
Do not block fan
Caution: Federal law (USA) restricts
this for sale or rental by or on the order
of a physician or licensed health care
provider.

FreeStyle Service Manual MN126-1 E
1-4
1.4 FreeStyle Specifications
Max Operational
Altitude:
up to 12,000 ft (3,657.6 m) (483mmHg) Higher altitudes may affect
performance
* Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70oF (21
o
C)
*Operating unit outside of normal operational temperature range can affect performance.
Oxygen Concentration:*
1-3 pulse settings; equivalent to a continuous flow of
90% +5.5/-3% Oxygen Concentration
Dimensions:
8.6 in. high x 6.1 in. wide x 3.6 in. deep
(21.8 cm high x 15.5 cm wide x 9.1 cm deep)
Weight:
4.4 lb (2.0 kg); 1.8 lb (.8 kg) optional Airbelt
Universal Power Supply:
AC Power Supply: 100 –240 VAC (1.0 amp at 120 VAC)
DC Power Supply: 11-16 VDC (6.0 amps max. at 13.5 VDC
nominal)
FreeStyle unit: 28 W nominal at 3 setting
Battery duration:
3 setting - 2 hours; 2 setting - 2.5 hours; 1 setting - 3.5 hours
Optional AirBelt when combined with the internal battery:
3 setting - 5 hours; 2 setting - 6 hours; 1 setting -10 hours
Battery charge time:
3.5 hours; optional AirBelt: 3 hours
Warm-up time:
2 minutes
Battery cycle life:
Approximately 300 cycles, then 80% capacity or below
Audible alarms and
pulse visual indicators:
Start-up –audible and visual (GREEN indicator light); Pulse
flow –visual (GREEN light); Battery condition –battery
level (GREEN indicator lights); Cannula disconnect- audible
and visual (RED alarm light); System overdraw –
audible and visual (RED warning and alarm lights); High and
low pressure –audible and visual (RED alarm light);
Service required: visual (YELLOW alarm light)
Sound:
38 dBA at 1 Setting: 41 dBA at 2 setting: 44 dBA at 3 setting
Temperature range
intended for use:
Operational temperature: 41oF to 104oF (5oC to 40
o
C)
Storage temperature: -4oF to 140oF (-20oC to 60
o
C)

FreeStyle Service Manual MN126-1 E
1-5
1.5 FreeStyle Classifications
Classification
Type of protection against electric shock:
Class II Protection from electric shock is achieved by double insulation.
Degree of protection against electric shock:
Type BFEquipment providing a particular degree of protection against electric shock regarding
1) allowable leakage current;
2) reliability of protective earth connection (if present).
Not intended for direct cardiac application.
Independent testing for Medical Electrical Equipment Standard.
Tested to be in compliance with:
IEC 60601-1 Medical Electrical Equipment –Part 1: General Requirements for Safety
Tested to be in compliance with applicable requirements of the Standard,
CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment –Part 1: General
Requirements for Safety
Protection against potential electromagnetic or other interference between the equipment and other
devices: Devicewithaccessoriestested to be in compliance with
EN 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety-Collateral
Standard: Electrical Compatibility - Requirements and Tests
RTCA / DO160 Airborne Equipment, Sec. 21, Emission of Radio Frequency Energy
CISPR 11 / EN 55011, Class B Group 1, “Industrial, Scientific, and Medical (ISM) Equipment”
FCC Part 15, Subpart B –Class B Unintentional Radiators
Method of cleaning and infection control allowed:
Please refer to the “Cleaning, Care, and Proper Maintenance” section of this FreeStyle
Service Manual.
Degree of safety of application in the presence of flammableanesthetic gases:
Equipment not suitable for such application.
Mode of operation:
Continuous duty.

FreeStyle Service Manual MN126-1 E
2-1
2.0 Operation Check and Test of Oxygen Concentration
2.1 Description of Operation
Air enters the FreeStyle Oxygen Concentrator through an external air intake /
gross particle filter. This filtered air enters the compressor via a suction intake
muffler that quiets the compressor’s suction sound. Pressurized air then exits
the compressor and passes through a heat exchanger to reduce the
temperature.
Next, a two-way solenoid feed valve directs the air into one of two sieve beds
that contain molecular sieve. The unique property of molecular sieve enables
it to physically attract (adsorb) nitrogen when air passes through this material,
thereby separating the nitrogen from the oxygen in ambient air.
There are two sieve beds: While one produces high-concentration oxygen, the
other is purged of the nitrogen it adsorbed (collected) while it made oxygen.
Oxygen exits the product tank after first passing through the integrated
product filter.
In addition to the molecular sieve beds that allow oxygen to be separated from
air, FreeStyle contains an Oxygen Conserving Device (OCD) valve that
controls delivery of high-concentration oxygen to the patient at the point in
the breathing cycle when the patient starts to inhale.
FreeStyle delivers a gas consisting of 90% (+5.5/-3% )oxygen at pulse flow
rates from approximately 1–3 LPM equivalency.
2.2 Operation Check
AirSep tests every FreeStyle Oxygen Concentrator thoroughly after
manufacture. You must perform the following test to ensure that no damage
occurred in shipping or handling.
1. Connect the power cord of the unit, and turn the unit on by pressing
flow setting [-2]. Check to see that the following sequence occurs:
a. A brief, continuous alarm sounds to indicate that FreeStyle has been turned on.
b. The compressor runs.
c. After a 10 second start up is complete.
d. Exhaust air flows from the unit.
2. Perform an oxygen concentration test, as described in Section 2.4.

FreeStyle Service Manual MN126-1 E
2-2 2
22
2.3 Alarm System
An audible alarm sounds if FreeStyle has a low battery, senses no
inspiration, or if performance is outside specifications. If an alarm sounds,
observe which lights are on. The visual and audible alarm conditions are
explained in detail below.
2.3.1 Start-Up
A one-second, audible alarm sounds to indicate start-up. FreeStyle begins to
operate when the alarm stops.
2.3.2 Battery Status
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 from 25-100% to indicate the level (capacity) of the internal
battery. At less than 25% capacity, the 25% LED blinks.
2.3.3 Low Battery
As the battery power approaches a low level, a ½ second beep is emitted every
five seconds, and a yellow LED on the battery gauge / indicator(s) will blink
for a ½-second every five seconds. When this occurs, the patient is instructed
to connect the FreeStyle UniversalAC or/ DC power supply or change to
another source of oxygen. The low battery alarm will continue for
approximately 2 minutes before FreeStyle stops operating.
2.3.4 Discharged Battery
When the battery is discharged, the unit shuts down. Before this occurs, a ½
second beep sounds every ½ second and the yellow battery LED blinks at the
same rate until any one of the 1-3 settings on the keypad are pressed. After the
alarm is turned off, connect the FreeStyle unit to its Universal AC or / DC
power supply or change to another source of oxygen immediately. When the
FreeStyle unit is connected to the Universal AC or / DC power supply,
FreeStyle operates and the internal battery recharges simultaneously.

FreeStyle Service Manual MN126-1 E
2-3
2.3.5 Battery Charging
To check the level of charge of the battery, press the BATT button on the keypad. The
battery gauge/indicator(s) illuminate to indicate the level of battery charge (25-100%).
To charge the FreeStyle’s internal battery:
Connect its Universal AC or / DC (auto) power supply into the
unit’s power receptacle located on the right side of the FreeStyle
unit, and the other end to its proper AC or DC power outlet.
The FreeStyle internal battery will completely charge from a fully
depleted state in approximately 3½ hours.
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 (½ second).
 The LED will continue toblink until a 25% capacityis 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.
 Once all LEDs illuminate solid, the battery is fully charged and the
LEDs will remain on solid for approximately 1 ½ hours, then all
four LEDs will turn off.
If the UniversalAC / DC power supply is not connected, the LEDs will turn of within
5 seconds.
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 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 AC or 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).

FreeStyle Service Manual MN126-1 E
2-4 2
22
2.3.6 Battery Fully Charged
When FreeStyle is connected to an AC or DC outlet and is either in operation or is off, the
green 100% battery gauge/indicators displays to indicate that the battery is fully charged.
2.3.7 Cannula Disconnect (No inspiration detected)
When FreeStyle is operating and does not sense breathing within 15
minutes, a red light will illuminate with a constant audible alarm. If this occurs, the
patient should be instructed to check the connection from the cannula to the FreeStyle
unit, make sure that the nasal cannula is positioned properly on the face, and ensure that
you are breathing through your nose. (Your physician may recommend the use of a chin
strap if needed.) If the alarm continues to sound,the patient should change to an alternate
source of oxygen and contact the Equipment Provider.
2.3.8 Performance Warning
If the user’s breathing rate causes the Freestyle unit’s capacity to be exceeded. The
amount of oxygen that FreeStyle supplies is dependent on the flow control switch setting
and the breathing rate. If the breathing rate is too fast for the flow selector setting, the
capacity of FreeStyle can be exceeded. The patient should reduce activity or consider
locating another source of oxygen.
2.3.9 FreeStyle Capacity Exceeded
When the patient’s breathing rate has caused the capacity of FreeStyle to be exceeded, a
1/2-second alarm sounds every 1/2 second, and the red alarm/ service light flashes. When
this occurs, oxygen concentration is outside specifications. The patient should reduce
activity or change to another source of oxygen and contact the Equipment Provider.
2.3.10 General Malfunction
If a general malfunction of the FreeStyle unit occurs, a 1/2 second alarm sounds every 1/2
second, and the red ALARM light turns on. When this occurs, oxygen concentration is
outside specifications. The patient should change to another source of oxygen and contact
the Equipment Provider.

FreeStyle Service Manual MN126-1 E
2-5
2.4 Oxygen Concentration Test and Specification
To ensure that FreeStyle’s oxygen output is within specification, you must
perform an oxygen concentration test. Test the unit upon delivery to a patient
and at periodic intervals. Equipment Providers, based upon their own expertise
and documentation, may establish and implement their own protocol to check
oxygen concentration.
1. Connect the FreeStyle Oxygen Concentrator using an AirSep-supplied
Universal AC or / DC power supply only (AirSep Part No. PW017-1) to a
100-240 volt, 50/60 Hz electrical outlet.
2. Turn unit on by pressing setting 2 on keypad.
3. Simultaneously press and hold settings 1 and 3 for 10 seconds. After 10
seconds, the alarm will sound and the LEDs above each flow setting will
illuminate verifying auto pulse mode.
Control Panel
Flow Settings 1 - 3
Figure 2.1
4. Allow unit to warm –up for 5 minutes before recording oxygen
concentration.
5. Connect a calibrated oxygen analyzer to the oxygen outlet and record the
unit’s concentration, a 12” tube is recommended. The specification in test
mode is 87% or higher.
Note Previous AC to DC power AirSep P/N PW010-1 can be used as well.

FreeStyle Service Manual MN126-1 E
3-1
3.0 Patient Instructions
3.1 General Instructions
It is important that patients thoroughly understand how to operate AirSep’s FreeStyle unit.
This enables proper treatment as prescribed by a qualified, licensed physician. You must
explain that the purpose of this therapy is to alleviate symptoms. If patients experience
any discomfort or if the unit alarms, they must notify their Equipment Provider and/or
physician immediately.
You, as the Equipment Provider, are responsible to ensure that each patient receives the
FreeStyle Patient Manual. Explain each step in the operation of the unit to the patient with
reference to the patient manual.
3.1.1 Connecting to External Power
When connecting the Universal AC / DC power supply to the FreeStyle unit, 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
aligned, and the button on the power cord must be pressed in for removal. This ensures
that neither the unit nor the power accessories are damaged.
FreeStyle unit’s
power inlet Press to remove
power cord.
“D”-shaped power cord plug
connects to the FreeStyle unit’s
“D”-shaped power inlet. Figure 3.1
3.1.2 Optional AirBelt™ Battery
Instruct patients that connecting an optional AirBelt to the unit by inserting
the power into the unit’s power inlet provides additional total run time, per the
specifications. Note that the unit battery must still have a charge remaining before the
external AirBelt is connected. The patient should be advised to not fully deplete the unit
battery as a small amount of power is needed to engage the AirBelt.

FreeStyle Service Manual MN126-1 E
3-2
To charge the AirBelt battery:
1) Release safetycap from end of the AirBelt cord.
2) Connect the AC/DC power supply (included with the AirBelt Accessory kit) to the end of AirBelts
power cord as shown in Figure 12.
3) Connect the AirBelt power supply to an AC electrical outlet to recharge.
Replace safety cap on AirBelt cord when not in use.
Do not attempt to charge the optional AirBelt with the any other power supply or the AirBelt can
be damaged. Use only the AirBelt power supply provided to charge AirBelt.
The FreeStyle AirBelt will completely recharge from its fully depleted state in approximately 3 ½ hours.
While charging a fully discharged battery, 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 the battery reaches
it’s 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.
The incorrect use of AirBelt can cause it 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.
Figure 3.2: AirBelt Battery Charging set up
F
i
g
u
r
e
4
AirBelt
PW009-2
AC/DC Power
Supply
F
i
g
u
r
e
4
AC/DC Power Supply
PW009-2 AC/DC Power Supply
F
i
g
u
r
e
4
Connecting the AirBelt cord to the power supply cord
PW009-2 AC/DC Power Supply
Figu
re 4