Portable Oxygen Concentrator

TABLE OF CONTENTS
General Information ……………………………………………………………………………………………………………………… 4
Introduction to the FreeStyle ………………………………………………………………………………………………………… 5
Introduction to the FreeStyle 5 ……………………………………………………………………………………………………... 7
Operating Specifications ……………………………………………………………………………………………………………..… 9
Alarm Types ………………………………..…………………………………………………………………..…………………………… 10
Classifications …………………………………………………………………………………………………………………………….... 11
Provider Support Policy ……………………………………………………………………………………………………………….. 12
Definition of Symbols ………………………………………………………………………………………………………………….. 13
How the FreeStyle and FreeStyle 5 Work …………………………………………………………………………………….. 14
Flow Rates ……………………………………………………………………………………………………………………………….….. 15
Indications for Use ………………………………………………………………………………………………………………………. 16
Contraindications ………………………………………………………………………………………………………………………… 17
Introduction ………………………………………………………………………………………………………………………………… 18
Pre-Delivery Checklist …………………………………………………………………………………………………………………. 18
Operation Check …………………………………………………………………………………………………………………………. 19
Alarm System ……………………………………………………………………………………………………………………………… 19
Oxygen Concentration Test ………………………………………………………………………………………………………… 21
Safety, Warnings, and Cautions ………………………………………………………………………………………………….. 22
Training the Patient ……………………………………………………………………………………………………………………. 23
Removable Battery Pack …………………………………………………………………………………………………………….. 23
Connecting to External Power ……………………………………………………………………………………………………. 27

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Control Panel Indicators and Alarms ………………………………………………………………………………………….. 39
Selecting the Proper Flow Setting ………………………………………………………………………………………………. 39
Active Lifestyle Training …………………………………………………………………………………………………………….. 39
Routine Maintenance by the Patient …………………………………………………………………………………………. 42
Patient Training Checklist ………………………………………………………………………………………………………….. 45
Equipment Provider Maintenance …………………………………………………………………………………………….. 47
Service ………………………………………………………………………………………………………………………………………. 52
Housing Removal ………………………………………………………………………………………………………………………. 53
PSA Removal …………………………………………………………………………………………………………………………….. 55
Compressor Replacement …………………………………………………………………………………………………………. 61
Product Manifold Replacement ………………………………………………………………………………………………… 63
Solenoid Valve Replacement ………………………………………………………………………………………………….…. 65
Sieve Bed Replacement …………………………………………………………………………………………………………….. 66
Feed/Waste Manifold Replacement ………………………………………………………………………………….………. 69
Measuring the System Pressure ………………………………………………………………………………………………… 71
FreeStyle Hour Meter ……………………………………………………………………………………………………………….. 73
Motor Controller Board Replacement ………………………………………………………………………………………. 75
Circuit Board Replacement ……………………………………………………………………………………………………….. 77
Key Pad Replacement ……………………………………………………………………………………………………………….. 81
Fan Replacement ………………………………………………………………………………………………………………………. 84
Troubleshooting ……………………………………………………………………………………………………………………..... 86
Accessories ………………………………………………………………………………………………………………………………. 90
CAIRE Inc. Contact Information ………………………………………………………………………………………………… 91

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GENERAL INFORMATIONThis technical manual will familiarize you with provider-specific information
regarding the FreeStyle and FreeStyle 5 portable oxygen concentrators.
Instructions in this manual are intended to help ensure that:- Providers are familiar with the FreeStyle and FreeStyle 5 system components
and system principles of operation- Providers are given proper guidance in the use of the FreeStyle and FreeStyle 5
and their accessories that can be conveyed to patients- Providers are made aware of the care, diagnostics, maintenance, and repair of
the FreeStyle and FreeStyle 5 units

Warning and Caution Statements
Safety instructions are defined as follows:
Warning – Important safety information for hazards that mightcause serious injury.

Caution – Important information for preventing damage to the
FreeStyle and FreeStyle 5.
Note – Places emphasis on an operating characteristic or
important consideration.

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INTRODUCTION TO THE FREESTYLE

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HandleOxygenOutletExternal
Power
Input

Air
Outlets
External
Battery
Pack
Air
Intake/Filter
Cover

Figure 1.1: External Components

Pulse
Flow
Indicators

Alarm/Service
Indicator

Battery
ChargeIndicators
Selector
Buttons

Figure 1.2: Control Panel

Rechargeable
Battery
Button

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INTRODUCTION TO THE FREESTYLE 5

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HandleOxygenOutletExternal
Power
Input

Air
Outlets

External
Battery
Pack

Air
Intake/Filter
Cover
Figure 2.1: External Components

Alarm/Service
Indicator

Pulse Flow
Indicators
Battery
ChargeIndicators

Selector
Buttons

Figure 2.2: Control Panel

External
Battery
Button
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FREESTYLE AND FREESTYLE 5 SPECIFICATIONS
Dimensions
Weight (w/ Battery Pack)
Sound Level
Flow Settings
Oxygen Concentration*
AC Power
DC Power
Battery Pack

FreeStyle
8.6 in x 6.1 in x 3.6 in(21.8 cm x 15.5 cm x 9.1 cm)
4.9 lbs (2.2 kg)
41 dB(A) at 2 setting
44 dB(A) at setting 3
Pulse Settings 1, 2, 3
90% oxygen +5.5/-3%
100-240 VAC, 50-60 Hz (1.75 ampsmax)
11–16 VDC (8.0 amps max)
Rechargeable, lithium battery

FreeStyle 5
10.7 in x 6.6 in x 4.4 in(27.2 cm x 16.8 cm x 11.2 cm)
6.7 lbs (3.0 kg)
43 dB(A) at setting 2
51 dB(A) at setting 5
Pulse Setting 1, 2, 3, 4, 5
90% oxygen +5.5/-3%
100–240 VAC, 50/60 Hz (2 amps max)

12-24 VDC (15 amps max)
Rechargeable, lithium battery
Setting 1 – 4.25 hours
Setting 2 – 2.5 hours
Setting 3 – 1.75 hours
Setting 4 – 1.5 hours
Setting 5 – 1.25 hrs

Battery Pack Durations

Setting 1 – 6.5 hours
Setting 2 – 3.5 hours
Setting 3 – 3 hours

Warm Up Time

2 minutes

2 minutes

Operating Temperature
Storage Temp. (Unit)

41°F to 104°F (5°C to 40°C)-4°F to 140°F (-20°C to 60°C)
1 month -4°F to +122°F (-20 to +50 C)
3 months -4°F to +104°F (-20 to +40C)
1 year -4°F to +68°F (-20 to +20C)
Up to 12,000 ft (3,657.6 m)<95%, non-condensing

41°F to 104°F (5°C to 40°C)-4°F to 140°F (-20°C to 60°C)
1 month -4°F to +122°F (-20 to +50 C)
3 months -4°F to +104°F (-20 to +40C)
1 year -4°F to +68°F (-20 to +20C)
Up to 12,000 ft (3,657.6 m)<95%, non-condensing)

Storage Temp. (Battery)
Operating Altitude
Operating Humidity* Based on an atmospheric pressure of 14.7 psia (101 kPa) at 70oF (21oC)* Operating unit outside of normal operational temperature range can affect performance.

The battery durations listed above are for new, fully charged batteries.
Battery durations will degrade over time due to environmental operating
conditions, usage, and operational condition of the concentrator.

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FREESTYLE AND FREESTYLE 5 ALARMS
StatusAudible Alarm

Start-Up

NormalOperation

Alarm

Light

Indicates

ActionBrief, continuous
at start–up(Green) pulse;
continuous light

FreeStyle or
FreeStyle 5 has been
turned on

You may begin to operate your
unit.

No

(Green) pulse;

FreeStyle or
FreeStyle 5 isdelivering oxygen asa pulse flow.

Continue using unit normally.

(Red) alarm;
continuous light

No breath detectedby the unit for apredetermined time
period.

Check the cannula connection.
Ensure that you are breathing
through your nose. If thealarm persists, contact yourEquipment provider.

Intermittent:

25% (Yellow)

Beep, beep, beep.

BATT; battery
indicator.

Battery voltage is too
low to operate the
FreeStyle or
FreeStyle 5

Connect the FreeStyle or
FreeStyle 5 unit into a DC
outlet or an AC outlet
immediately.

Rapid intermittent:(Red) alarm;

Beep, beep, beep

intermittent light

Breathing rate isexceeding thecapacity of the
FreeStyle or
FreeStyle 5 unit.

Reduce activity, then if
necessary use another sourceof oxygen as available. Contact
your Equipment Provider.

Rapid intermittent:(Red) alarm;
continuous light

General malfunctionof the FreeStyle or
FreeStyle 5 unit has
occurred.

Turn off the unit. Change toanother source of oxygen, andcontact yourintermittent lightContinuous:
Beep

Alarm

Alarm

Alarm

Beep, beep, beep

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FREESTYLE AND FREESTYLE 5 CLASSIFICATIONSClassification
Type of protection against electric shock:Class II Protection from electric shock is achieved by double insulation.
Degree of protection against electric shock:Type BF Equipment providing a particular degree of protection against electric shock
regarding:1) Allowable leakage current
2) Reliability of protective earth connection (if present).
Not intended for direct cardiac application.
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 andother devices.
Device with accessories tested to be in compliance with:
EN 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for SafetyCollateral 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 allowed:
Please refer to the “Cleaning, Care, and Proper Maintenance” section of this Technical
Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suitable for such application.
Mode of operation:
Continuous duty.
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PROVIDER SUPPORT POLICY
Objective: As a manufacturer our organizational goal is to provide customer support andassistance to the highest level of excellence.

Customers are Providers (which include Dealers, Distributors and Agents).
Support includes, but is not limited to, troubleshooting and Return Material
Authorizations (RMA).
Business Hours: Monday – Friday, 8:30am – 5:00pm EST.

CAIRE can only support customers who are recognized as Providers, Dealers, Distributors
and/or Agents. These partnerships are qualified as having an existing account or are in theprocess of credit application completion. All patient or end-user inquiries including but notlimited to RMA, warranty or serial number questions must be handled by their Provider.

Provider Support Policy: CAIRE is unable to provide direct
assistance, clinical advice, or recommendations to a patient or enduser. Providers have sole responsibility in assisting their patients.

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DEFINITION OF SYMBOLS

Symbols are frequently used on equipment and/or the manual in preference to words with theintention 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 and FreeStyle 5:

Symbol

RTCA/DO160
Section 21
Category M
Compliant

Definition

SymbolDefinition

Consult instructions for use

Do not disassemble

No Smoking Icon: Do not smokenear unit.

Use no oil or grease.

This side up

No open or naked flames.

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 electricalequipment

Fragile – handle with care

Safety agency for CAN/CSA C22.2 No.
601.1 M90 for medical electricalequipment

Type BF Equipment

Name and address of manufacturer

FAA Approved – POC
Serial Number

Authorized representative in the European
Community

Catalog number

Date of Manufacture

Do not get wet.
If the product unique device identifier (UDI)
label has the CE#### symbol on it, the device
complies with the requirements of Directive
93/42/EEC concerning medical devices. The
CE#### symbol indicates notified bodynumber.
This symbol is to remind the equipment
owners to return it to a recycling facility atthe end of its life, per Waste Electrical andElectronic Equipment (WEEE) Directive.

Class II Equipment

Prescription only

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HOW THE FREESTYLE AND FREESTYLE 5 WORKThe FreeStyle and FreeStyle 5 are portable oxygen concentrators (POC) used to extract oxygenfrom the atmosphere, concentrate it to 87–95.5%, and present the oxygen to the patient in theform of a bolus (pulse dose). These devices operate from either external power or from arechargeable battery pack.

Description of Operation
Air enters the POC 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 heatexchanger to reduce the temperature.
Next, a solenoid feed valve directs the air into one of two sieve beds that containmolecular sieve. The unique property of molecular sieve enables it to physicallyattract (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 otherpurges the nitrogen it adsorbed via the solenoid waste valve and exhaust. Oxygen
exits the product tank after first passing through the integrated product filter.
In addition to the molecular sieve and product tank, the FreeStyle and FreeStyle 5
contain an Oxygen Conserving Device (OCD) valve that controls delivery of highconcentration oxygen to the patient when the pressure sensor senses the patient’s
inspiration.

Figure 3: Flow Schematic Diagram
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FREESTYLE AND FREESTYLE 5 FLOW RATESThe pulse delivery will adjust the volume delivered each breath to maintain aconstant volume per minute:
Flow Setting
Setting 1
Setting 2
Setting 3
Setting 4
Setting 5

FreeStyle
Volume(mL/min)
227.5 mL/min
420 mL/min
500 mL/min
N/A
N/A

Figure 4: Pulse Profiles

FreeStyle 5
Volume (mL/min)
227.5 mL/min
420 mL/min
630 mL/min
840 mL/min
1000 mL/min

Example Calculation: Setting 2 at 20 Breaths Per Minute (BPM)

420 𝑚𝑚𝑚𝑚/𝑚𝑚𝑚𝑚𝑚𝑚= 21 𝑚𝑚𝑚𝑚/𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏ℎ
20 𝐵𝐵𝐵𝐵𝐵𝐵

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INDICATIONS FOR USE
The FreeStyle and FreeStyle 5 POC’s are indicated for the administration of
supplemental oxygen. These devices are not intended for life support nor do they
provide any patient monitoring capabilities.
A physician must prescribe a specific oxygen pulse dose setting to meet patients’
individual needs.
Recommended oxygen flow rates should be adjusted only under the advice of aphysician.

Federal (USA) law restricts this device to sell or rental by order of aphysician or other licensed health care provider.

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.

This unit is not to be used for life support. Geriatric, pediatric, or any
other user unable to communicate discomfort while using thisdevice may require additional monitoring. Users with hearing and/orsight impairment(s) may need assistance with monitoring alarms.

Pulse dose settings must be determined for each user individuallyfor their needs at rest, during exercise, and when traveling.

The portable oxygen concentrator may be used during sleep under
the recommendation of a qualified clinician.

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CONTRAINDICATIONSThe FreeStyle and FreeStyle 5 POC’s are not intended for life
supporting or life sustaining applications, nor do they provide any
patient monitoring capabilities.

In certain circumstances, the use of non-prescribed oxygen can be
hazardous. These devices should only be used when prescribed by aphysician.

Not for use in the presence of flammable anesthetics.

As with any electrically powered device, the user may experience
periods of non-operation as a result of electrical power interruption,or the need to have the POC unit serviced by a qualified technician.
The FreeStyle and FreeStyle 5 units are not appropriate for any user
who would experience adverse health consequences as a result ofsuch temporary interruption.

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INTRODUCTION
Welcome to the CAIRE FreeStyle and FreeStyle 5 portable oxygen concentrators. Setting up andtraining your patient to use the FreeStyle or FreeStyle 5 has never been easier! You can expect
your patients and care providers to easily learn how to use the device by following thedirections in this section. While setting up and training a patient, be sure to point out theadvantages of the FreeStyle and FreeStyle 5. For example:• Easy-to-use controls• FreeStyle battery pack• Quiet operation• Alarm system
After completing each training procedure, ask your patient if he or she has any questions.
Proper training of your patients will result in fewer service calls, improved compliance, andincreased patient satisfaction.

PRE-DELIVERY CHECKLISTVerify that the FreeStyle or FreeStyle 5 is provided to the patient with the following items:
FreeStyle:• Carrying Bag• Shoulder Strap• Carry-All Accessory Bag• Battery Pack
• AC/DC Universal Power Supply• AC Power Cord
• DC Power Cable• User’s Manual
FreeStyle 5:• Carrying Bag• Shoulder Strap• Carry-All Accessory Bag• Battery Pack
• AC Power Supply• DC Power Supply• User’s Manual

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The FreeStyle comes with a universal (AC and DC) power supply. The
FreeStyle 5 comes with an AC power supply and a separate DC power
supply.

FREESTYLE AND FREESTYLE 5 OPERATION CHECKCAIRE tests every FreeStyle and FreeStyle 5 POC thoroughly after manufacture. The provider
must perform the following checks and tests to ensure that no damage occurred in shipping or
handling:
Do not connect external power without a battery pack installed in the FreeStyle or
FreeStyle 5

The FreeStyle or FreeStyle 5 must be off and disconnected from external power before
removing the battery pack.

1. Install the battery pack.
2. Connect the AC Power Supply to the POC, and connect the AC power cord from the Power
Supply to a 100-240 volt, 50/60 Hz electrical outlet.
3. 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 the POC has been turned on.
b. The compressor starts.
c. Exhaust air flows from the unit.
4. Perform an oxygen concentration test, as described in the OXYGEN CONCENTRATION TEST
section of this manual.

FREESTYLE AND FREESTYLE 5 ALARM SYSTEMSTART-UP ALARM
A brief alarm sounds when the FreeStyle or FreeStyle 5 is first powered on. This is normal. The
concentrator begins to operate once the brief alarm stops.
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LOW BATTERY ALARM
As the battery pack power approaches a low level, a brief alarm sounds intermittently and theyellow 25% battery gauge indicator light will illuminate intermittently. When this occurs,connect the FreeStyle or FreeStyle 5 to an AC or DC power outlet, or change to an alternate
oxygen source.
When connected to AC or DC power, the concentrator will operate while recharging the battery
pack.

CANNULA DISCONNECT
When a FreeStyle or FreeStyle 5 is operating but does not sense breathing, a constant alarmsounds, and the alarm light illuminates after 15 minutes. If this occurs, check the connection fromthe cannula to the unit, make sure that the nasal cannula is positioned properly on your face, andensure that you are breathing through your nose. If the alarm continues to sound, change toanother source of oxygen as available, and contact your Equipment Provider.
BREATH RATE EXCEEDED
If your breathing rate causes the capacity of unit to be exceeded, a rapid alarm sounds every ½
second, and the alarm light illuminates red intermittently. When this occurs, the concentrationof oxygen that the unit is supplying is outside of the unit specifications. You should reduce any
physical activity, reset alarm by turning unit off and back on, and then if necessary change toanother source of oxygen as available, and contact your Equipment Provider.
GENERAL MALFUNCTION
If a FreeStyle or FreeStyle 5 has a general malfunction, a rapid alarm sounds every ½ second, andthe alarm light illuminates red continuously. When this occurs, the concentration of oxygen thatthe unit is supplying is below unit specifications. You should change to another source of oxygen
as available, and contact your Equipment Provider.

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OXYGEN CONCENTRATION TEST AND SPECIFICATIONTo ensure that FreeStyle or FreeStyle 5 oxygen output is within specification, the provider must
perform an oxygen concentration test. Test the unit upon delivery to a patient and at periodic
intervals.
Do not connect external power without a battery pack installed in the
FreeStyle or FreeStyle 5

The FreeStyle or FreeStyle 5 must be off and disconnected from external
power before removing the battery pack.

Equipment Providers, based upon their own expertise and documentation,
may establish and implement their own protocol to check oxygen
concentration.

1. Connect the POC using the supplied AC power supply 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 ten seconds if using a

FreeStyle. Simultaneously press and hold settings [1] and [5] for ten seconds if
using a FreeStyle 5. After apporximately ten seconds, the alarm will sound and theLEDs above each flow setting will illuminate verifying auto pulse mode (TestMode).

4. Allow the 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.

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SAFETY GUIDELINES AND OPERATIONAL SAFETY,WARNINGS, AND CAUTIONSProvider should review all safety guidelines and operational safety Warnings/Cautions witheach patient. In addition, provider should carry out a risk assessment prior to installation of the
FreeStyle or FreeStyle 5 to assure proper connection and compatibility with other equipment
the patient may be using.
No Smoking or Open Flames. For safety concerns, all possible sources of ignition
must be kept away from the oxygen system and preferably out of the room inwhich it is being used. Smoking in the proximity of an operation oxygen
concentrator is extremely dangerous and can permanently damage the device
and void the warranty. Keep the POC at least five (5 ft) feet (1.5 m) from heatsources, sparking objects, or open flames.

Ask your patient where they would like to set up the device. While unpacking and setting up
the device, tell your patient about these important cautions and warnings:
Locate the unit in a well-ventilated space that provides adequate air flow.
Ensure that furniture, draperies, or clothing will not impede air circulation.
Avoid placing the unit over a floor heat register or against a baseboard heating
system.
Do not use in the presence of flammable anesthetics, solvents, aerosols, or
flammable cleaning agents.
Avoid high pollutant environments.
Some patients are highly mobile and may use the device under varying
circumstances. Make sure your patient or patient caregiver completely
understands the basic precautions to safely locate the device.

After completing this training procedure, ask your patient if they have any
questions.

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TRAINING THE PATIENT
It is important that patients thoroughly understand how to operate the FreeStyle or Freestyle 5
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.
Give the patient a copy of the Users Manual and advise them to read prior to operating theunit. Open the manual and briefly review the Table of Contents, including subheadings. Show
your patient the icons and symbols and explaim what each one means. Explain each step in theoperation of the unit to the patient with reference to the patients User Manual.
Advise your patient to thoroughly read the User Manual and keep the
manual in a safe place for future reference.

Power Supplies
The FreeStyle and FreeStyle 5 can be powered in 3 ways:
Battery Pack
AC Power
DC Power
Do not connect external power without a battery pack installed in the FreeStyle or
FreeStyle 5

Information on the operation of each of these components is in the following sections:

BATTERY PACKThe FreeStyle or FreeStyle 5 can be operated by the rechargeable battery pack which issupplied with the device. There are no operational limitations of the concentrator whenrunning from power supplied from the battery pack. All flow rates are available on battery
power.
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Figure 5.1: Removable Battery Pack
INSTALLING THE BATTERY:
Align the battery with the front housing from the right side of the FreeStyle or FreeStyle 5 sothat it will slide into the empty compartment. Push the battery inward until you hear a click to
confirm that it has locked in place.

Figure 5.2: Battery Pack Installation
REMOVING THE BATTERY:The FreeStyle or FreeStyle 5 must be off and disconnected from external
power before removing the battery pack.
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Push the battery release button outward away from the FreeStyle or FreeStyle 5. While
HOLDING this button, slide the battery out by pulling it away from the concentrator. Use thedepressed finger slot to grip the battery when pulling outward.

Figure 5.3: Battery Pack Removal

CHECKING BATTERY PACK CHARGE:
To check the battery charge when it is installed in the FreeStyle or FreeStyle 5, press the “BATT”
battery status button on the control panel of the concentrator. The battery gauge indicatorlights (25-100%) will illuminate above the BATT button to indicate the level of the battery packcharge.

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Figure 5.4: Keypad Battery Status Indicator
To check the battery charge when it is not installed in the FreeStyle or FreeStyle 5, turn thebattery on its back and press the TEST button. The battery gauge indicator lights (25-100%) will
illuminate, to the left of the TEST button, to indicate the level of the battery pack charge.

TEST
ButtonFigure 5.5: Battery Pack TEST Button

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CONNECTING TO EXTERNAL POWER
INITIAL CHARGING:
The new battery supplied with your FreeStyle or FreeStyle 5 is partially charged when it isshipped from the factory. Before using for the first time, you should fully charge the battery
pack using either AC or DC power.
Do not connect external power without a battery pack installed in the FreeStyle or
FreeStyle 5

GENERAL CHARGING INFORMATION:
The FreeStyle and FreeStyle 5 will recharge the battery pack anytime it is installed in theconcentrator and the concentrator is connected to an external AC or DC power source.
While charging a fully discharge battery, the 25% battery gauge indicator light on top of the
FreeStyle or FreeStyle 5 will begin by blinking rapidly for a few minutes, and then start to blink
at a slower rate (every ½ second). The LED will continue to blink until 25% battery capacity isreached. The LED will then turn solid. Each of the 4 battery gauge indicator lights (25-100%)
will blink as stated above during charging, then turn solid when they reach capacity.
When all 4 of the battery gauge indicator lights are solid, the battery is fully charged. The lights
will remain on for a short period of time to indicate a full change, and will then turn off.
Alternately, the battery pack may be charged using the optional desktop charger. Reference
the manual for the desktop charger (MN211) for instructions on its operation.
BATTERY OPERATING DURATION:
When external AC or DC power is disconnected, the concentrator will automatically switch overto using battery power if the battery pack is installed and has a charge. The table below shows
the typical durations for a new battery pack.
Battery pack durations will remain constant regardless of your breath rate.
FreeStyle
Setting 1 - 6.5 hours(6 hrs, 30 minutes)
Setting 2 - 3.5 hours(3 hrs, 30 minutes)
Setting 3 - 3.0 hours(3 hrs)FreeStyle 5
Setting 1 - 4.25 hours(4 hrs, 15 minutes)
Setting 2 – 2.5 hours(2 hrs, 30 minutes)
Setting 3 - 1.75 hours(1 hr, 45 minutes)
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FreeStyle 5-

Setting 4 - 1.5 hours(1 hr, 30 minutes)
Setting 5 -1.25 hours(1 hr, 15 minutes)

The battery pack durations listed above are for new, fully charged
batteries. Battery pack durations will degrade over time due toenvironmental operating conditions, usage, and operational condition of
the concentrator.

TYPICAL BATTERY RECHARGE TIME:
The typical time to recharge your battery pack inside of the FreeStyle or FreeStyle 5 to achieve
full capacity from a fully discharged battery is between 4-5 hours.
If using the optional desktop charger, the battery pack will fully charge in 4-5 hours.

FREESTYLE AC & DC POWER SUPPLYThe FreeStyle is equipped with a universal AC/DC power supply is an all-in-one way to keep
your concentrator powered wherever you go. It replaces separate AC and DC power supplies so
you only have a carry and keep up with one power supply.
The universal power supplied with the Freestyle includes the following:
1. Universal power supply (brick) which operates on:
AC Power between 100-240 volts, 50-60Hz.
DC Power sources including 12V automobile accessory outlets
2. Removable AC power cord
Plug style varies by country or location of purchase
3. Removable DC Power Cord

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Figure 6: FreeStyle Universal Power Supply
AC POWER
AC power is for use at home or wherever standard AC outlet power is available. The FreeStyleis fully functional on AC power for use. The unit will also recharge the battery pack if needed
any time AC power is available. The battery pack will recharge both if the unit is off or on andin use.

To connect the FreeStyle to AC Power:
Connect the universal power supply to the power connector inlet on the side of the FreeStyle.
Be sure to push inward so that the connection is secure.

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Figure 6.1: Connecting Power Supply to FreeStyle
Connect the AC power cord to the unmarked AC inlet on the power supply

Figure 6.2: Connecting AC Cable to Power Supply
Connect the opposite end of the AC power cord to the wall or other appropriate electricaloutlet.
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Figure 6.3: Connecting Power Supply to AC Outlet
Ensure the green light on top of the Universal power supply is illuminated. This indicates thatthe power supply is receiving power from the outlet. If the green light is not illuminated, checkfor secure connections and refer to the troubleshooting section of this manual.

Green Light

Figure 6.4: Green Light on Universal Power Supply
If the battery pack is in need of re-charge, the battery status indicator lights should blink
accordingly to show charging (reference page xx for charging information).
Turn on the FreeStyle by pressing the numeric flow selection button of the pulse flow settingprescribed by your physician to turn on the device.
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DC POWER
DC power is for use in the accessory outlets of automobiles, boat, or other motor vehicles. The
FreeStyle is fully functional on DC power for use. The FreeStyle will also recharge the battery
pack if needed any time DC power is available. The battery pack will recharge both if the unit isoff or on and in use.
Connect the universal power supply to the power connector inlet on the side of the FreeStyle.
Be sure to push inward so that the connection is secure.

Figure 6.5: Connecting Power Supply to FreeStyle
Connect the DC power cord to the inlet marked “ACCESSORY DC IN” on the universal power
supplyFigure 6.6: Connecting DC Cable to Universal Power Supply
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Connect the opposite end of the DC power cord to automobile or other DC accessory outlet.

Figure 6.7: Insert DC Adapter to DC Outlet
Turn on your motor vehicle.
Ensure the green light on top of the Universal power supply is illuminated. This indicates thatthe power supply is receiving power from the outlet. If the green light is not illuminated,disconnect the power supply from the DC outlet, restart the motor vehicle, and then reconnect
the power supply to the DC outlet.

Green Light

Figure 6.8: Green Light on Universal Power Supply

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If the battery pack is in need of re-charge, the battery status indicator lights should blink
accordingly to show charging.
Turn on the FreeStyle by pressing the numeric flow selection button of the pulse flow settingprescribed by your physician to turn on the device.

FREESTYLE 5 AC & DC POWER SUPPLYThe FreeStyle 5 is equipped with separate power supplies for AC and DC operation.
The FreeStyle 5 includes the following:
1. AC power supply which operates on AC Power between 100-240 volts, 50-60Hz.
2. Removable AC power cord
3. DC Power Supply which operates on DC Power sources including 12V automobile
accessory outlets

Figure 7: FreeStyle 5 DC and AC Power Supplies
AC POWER
AC power is for use at home or wherever standard AC outlet power is available. The FreeStyle 5
is fully functional on AC power for use. The FreeStyle 5 will also recharge the battery pack if
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needed any time AC power is available. The battery pack will recharge both if the unit is off oron and in use.
To connect the FreeStyle 5 to AC Power:
Connect the AC power supply to the power connector inlet on the side of the FreeStyle 5. Be
sure to push inward so that the connection is secure.

Figure 7.1: Connecting Power Supply to FreeStyle 5
Connect the AC power cord to the inlet on the power supply.

Figure 7.2: Connecting AC Cable to Power Supply
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Connect the opposite end of the AC power cord to the wall or other appropriate electricaloutlet.

Figure 7.3: Connecting Power Supply to AC Outlet
Ensure the green light on top of the AC power supply is illuminated. This indicates that thepower supply is receiving power from the outlet. If the green light is not illuminated, check forsecure connections and refer to the troubleshooting section of this manual.

Green Light

Figure 7.4: Green Light on AC Power Supply
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If the battery pack is in need of re-charge, the battery status indicator lights should blink
accordingly to show charging (reference page xx for charging information).
Turn on the FreeStyle 5 by press the numeric flow selection button of the pulse flow settingprescribed by your physician to turn on the device.
DC POWER
DC power is for use in the accessory outlets of automobiles, boat, or other motor vehicles. The
FreeStyle 5 is fully functional on DC power for use. The FreeStyle 5 will also recharge thebattery pack if needed any time DC power is available. The battery pack will recharge both if
the unit is off or on and in use.
Connect the universal power supply to the power connector inlet on the side of the FreeStyle.
Be sure to push inward so that the connection is secure.

Figure 7.5: Connecting Power Supply to FreeStyle 5
Connect the DC power cord to automobile or other DC accessory outlet.

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Figure 7.6: Insert DC Adapter to DC Outlet
Turn on your motor vehicle.
Ensure the green light on top of the DC supply is illuminated. This indicates that the power
supply is receiving power from the outlet. If the green light is not illuminated, disconnect thepower supply from the DC outlet, restart the motor vehicle, and then reconnect the power
supply to the DC outlet.

Green Light

Figure 7.7: Green Light on AC Power Supply
If the battery pack is in need of re-charge, the battery status indicator lights should blink
accordingly to show charging (reference page xx for charging information).
Turn on the FreeStyle 5 by press the numeric flow selection button of the pulse flow settingprescribed by your physician to turn on the device.

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SHOWING PANEL BUTTONS, INDICATORS, AND ALARMSShow your patient where each button is located on the POC Control Panel and how each button
and indicator operates. Go over the alerts and alarms and how to handle alert and alarm
conditions.

SELECTING THE PROPER FLOW SETTING
The recommendations of the qualified clinician responsible for the patient’s care should always
be followed when instructing patients on the use of Pulse Dose Mode.

Do not attempt to prescribe oxygen level settings. Warn your patientthat only a qualified clinician or physician is to perform the necessary
tests to prescribe treatment.

ACTIVE LIFESTYLE TRAINING
Small, lightweight, and easily moved about, the FreeStyle and FreeStyle 5 units are ideallysuited to an active lifestyle. The AC and DC power supplies enable recharge of the battery
during longer excursions. CAIRE recommends a nasal cannula with 7 ft (2.1 m) of tubing, CAIREPart Number CU002-1, or suitable cannula. Other lengths of non-kinking / star channel cannula
can be used for a total length of up to 25 ft (7.6 m) maximum.

Always follow the cannula manufacturer’s instructions for proper use.
Consult your licensed health care provider to determine how often thecannula should be replaced.

Cannula tubing must be non-kinking, which can be used for a total
length of up to 25ft (7.6cm) maximum.

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Ensure the cannula is fully inserted and secure. This ensures that the unit canproperly detect inspiration for oxygen delivery.

No Smoking or Open Flames. For safety concerns, all possible sources ofignition must be kept away from the oxygen system and preferably out of theroom in which it is being used. Smoking in the proximity of an operation oxygen
concentrator is extremely dangerous and can permanently damage the device
and void the warranty. Keep the POC at least five (5 ft) feet (1.5 m) from heatsources, sparking objects, or open flames.
Always place oxygen supply tubing and power cords in a manner that prevents
trip hazards or possible accidental strangulation.

To train your patient on mobility and ambulation, follow the procedures below:

TRAVELING BY VEHICLE

Ask your patient whether he or she will be using the device to travel by vehicle. If so, show yourpatient how to safely use the POC while driving. Refer to the CONNECTING TO EXTERNALPOWER section of this manual for proper setup of the unit in a vehicle.

Whenever possible, go to your patient’s vehicle to demonstrate how toconnect the unit to DC power.

Be sure to accurately determine the amount of current the vehicle accessory
outlet is rated to supply.

•••

Avoid placing the FreeStyle or FreeStyle 5 in direct sunlight.
Do not store the unit in a vehicle where the device may be subject toextreme temperatures. Extreme heat or cold may impair operation anddamage the device and degrade the battery.
When using the FreeStyle or FreeStyle 5 in a vehicle, check the cannula to
make sure it is not pinched or occluded.
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TRAVELING BY AIR

A new US Department of Transportation regulation regarding portable oxygen concentrators
took effect on May 13, 2009. Under this regulation, every FAA approved portable concentrator
is now authorized for use during any commercial flight that departs or arrives in the USA,regardless of whether the airline itself has approved the device or not.
If the airline allows use of the FreeStyle or FreeStyle 5, DO NOT use DC or AC Power Adapterson the aircraft. The patient must ensure that they have an adequate number of spare batteries
to last for the duration of their trip.
During taxi, take-off and landing the unit must be turned off and stowed under the seat or inanother approved stowage location as to not block the aisle way or the entry way into the row
if the unit will not be used.
During taxi, take-off and landing the user must be in a seat location that does not restrict anyother passenger’s access to, or use of any required emergency or regular exit, or the aisle(s) inthe passenger compartment of the aircraft if the unit is used.
Users are not permitted to be seated in an exit row if using the FreeStyle or FreeStyle 5.
If the FreeStyle or FreeStyle 5 is used when decompression of the cabin occurs, and the cabin
oxygen system deploys, then the user is to discontinue use of the POC and use the aircraft
supplemental oxygen. The FreeStyle or FreeStyle 5 unit is to be turned off after securing theaircraft supplemental oxygen.
Prior to travel, the user needs to inspect the unit to ensure that it is in good operational
condition.
Visit our website, www.cairemedical.com, and look for the Travel Approved document on our
Respiratory Knowledge Center for helpful travel tips.
Each airline has their own requirements and CAIRE recommends
checking those requirements prior to making a trip.

TRAVELING BY CRUISE SHIP

When traveling by watercraft, instruct your patient to inform the cruise line that the FreeStyle
or FreeStyle 5 will be used onboard. Each cruise line has a Special Needs coordinator that cananswer any questions regarding travel and the cruise line’s individual requirements. Have yourpatient contact the cruise ship Special Needs Coordinator directly.

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TRAVELING BY TRAIN

When traveling by train, instruct your patient to inform the rail line in advance that the
FreeStyle or FreeStyle 5 will be used onboard. Operate the unit only from the battery pack. The
patient must ensure that they have an adequate number of spare batteries to last for theduration of their trip.

USAGE DURING SLEEPCAIRE recommends that the FreeStyle or FreeStyle 5 be used while sleeping with the guidanceof the prescribing clinician. In addition, some patients who mouth-breathe while asleep may
benefit from the use of a chin strap.

ROUTINE MAINTENANCE BY THE PATIENTTo ensure accurate output and efficient operation of the unit, the patient must perform simple
routine maintenance tasks:• Clean the air intake / gross particle filter, cabinet, and power supplies weekly.

CLEANING THE AIR INTAKE / GROSS PARTICLE FILTER
Turn OFF the unit and disconnect the power cord from the electricaloutlet before you clean the unit to prevent accidental electrical shockand burn hazard.

Remove the battery from the unit before performing any maintenance toprevent accidental electrical shock and burn hazard.

The FreeStyle or FreeStyle 5 must be off and disconnected from external power
before removing the battery pack.

The patient must clean this filter weekly, as described below. The filter may
require daily cleaning if the unit operates in a harsh environment, for example, ahouse heated by wood, kerosene, or oil, or one with excessive cigarette smoke.

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1. The air intake / gross particle filter can be found on the lower front of the unit, as seen in
the figure below.

Air
Intake/Filter
Cover
Gross
Particle
FilterFigure 8: Air Intake and Gross Particle Filter

2. Power down the unit
3. Pull the filter cover off the front of the unit and remove the filter. Wash filter in a warm
water and soap solution
4. Rinse the filter thoroughly, and remove excess water with a soft, absorbent towel. Ensurethat the filter is dry before replacing it.
5. Replace the dry filter into the filter cover.
6. Place the filter cover back into the housing and gently push into place.

CLEANING THE CABINET AND POWER SUPPLIES
Turn OFF the unit and disconnect the power cord from the electricaloutlet before you clean the unit to prevent accidental electrical shockand burn hazard.
Remove the battery from the unit before performing any maintenance toprevent accidental electrical shock and burn hazard.
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The FreeStyle or FreeStyle 5 must be off and disconnected from external power
before removing the battery pack.

1. Turn OFF the unit and disconnect it from AC or DC power before any cleaning or disinfection
activity.
2. Remove the battery from the unit.
3. Use mild detergent and water solution.
4. Use a damp (not soaking wet) cloth or sponge.
5. Spray or wet the cloth or sponge with the mild detergent solution. DO NOT spray thecabinet, control panel, or power supplies.
6. Wipe down the cabinet, control panel, and power supplies.

CANNULA REPLACEMENT

Always follow the cannula manufacturer’s instructions for proper use. Replace the nasal
cannula or oxygen tubing as recommended by the cannula manufacturer or your oxygen
provider. Your physician or oxygen provider will provide you with cleaning and replacement
instructions.
Additional supplies for replacement are available through your oxygen provider.

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PATIENT TRAINING CHECKLISTPatient Name:
AC/DC Power Supply
Serial #Unit Serial #Training Topic

Initials

Pre-Delivery Check List
Indications for Use
Contraindications
Basic Concept Training
Advise to read the User’s Manual
Go over all Accessories included with the Unit
Safety Guidelines and Operational Safety Warnings/Cautions
Locating the Unit
Panel Buttons and Indicators
Alerts and Alarms
Selecting Flow Setting
Connecting the AC Power Supply
Connecting the DC Power Supply
Active Lifestyle Training
Operating the unit Battery power

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Use Around the House
Traveling by Vehicle
Traveling by Air
Traveling by Boat
Traveling by Train
FreeStyle MaintenanceWeekly: Clean the Air Inlet Gross Particle Filter
Weekly: Clean the Cabinet, Control Panel, and Power Supplies
Trained By:

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EQUIPMENT PROVIDER MAINTENANCENO SCHEDULED MAINTENANCE

FreeStyle and FreeStyle 5 units are maintenance-free due to their technologically advanced
design. CAIRE does not require preventative maintenance or service on these concentrators aslong as the concentrator remains within specifications. To ensure that the unit’s output ofoxygen is within specification, you must establish and implement a protocol to check oxygen
concentration upon delivery to a patient and at periodic intervals (Reference OXYGENCONCENTRATION TEST section of this manual).

AIR INTAKE / GROSS PARTICLE FILTER

The external air intake gross particle filter is located in the air intake/filter cover. You can easily
remove it by hand. Instruct the patient to clean this filter weekly. (Reference CLEANING THE AIRINTAKE / GROSS PARTICLE FILTER section of this manual).

The filter may require more frequent cleaning if the unit operates in a harshenvironment – a house heated by wood, kerosene, or oil, or one with excessive
cooking or cigarette smoke.
Turn OFF the unit and disconnect the power cord from the electricaloutlet before you clean the unit to prevent accidental electrical shockand burn hazard.

Remove the battery from the unit before performing any maintenance toprevent accidental electrical shock and burn hazard.

The FreeStyle or FreeStyle 5 must be off and disconnected from external power
before removing the battery pack.

PRODUCT FILTER REPLACEMENT

The product filter is designed to last the life of the unit. If it is determined that the product filter
needs to be replaced, follow the instructions below:
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1.
2.
3.
4.
5.
6.
7.

Turn unit off and disconnect the power cord.
Remove the back housing, and locate the product filter/volume tank. See figure below.
Disconnect tubing from the inlet of the product filter/volume tank.
Unscrew the product filter/volume tank from the product manifold
Place the o-ring into the o-ring groove located on top of the volume tank.
Fasten the new product filter/volume tank to the product manifold.
Connect the tubing and secure with a tie-wrap.

Product
FilterCompressor
Felt Filter

Figure 9: Product Filter
If the compressor inlet felt filter (shown above) is contaminated, areplacement felt filter can be ordered by contacting CAIRE andreferencing Part Number FI143-2

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CLEANING AND PREPARING FOR NEW PATIENT USE

When you remove the FreeStyle or FreeStyle 5 from a patient’s home, always detach anddispose of the used nasal cannula. Clean the exterior of the unit with a mild household cleaner
applied with a damp cloth or sponge. Pay special attention to the oxygen outlet for the cannula
connection to make sure it remains free of dust, water, and particles. Be careful not to get any
liquid into the interior of the unit.
Next, clean the exterior with a common chemical disinfectant before any other patient uses theunit. Do not use liquid directly on the unit to clean it.
Turn OFF the unit and disconnect the power cord from the electricaloutlet before you clean the unit to prevent accidental electrical shockand burn hazard.

Remove the battery from the unit before performing any maintenance toprevent accidental electrical shock and burn hazard.

The FreeStyle or FreeStyle 5 must be off and disconnected from external power
before removing the battery pack.

Do not use liquid directly on the FreeStyle or FreeStyle 5 unit to clean it. A list ofundesirable chemical agents includes but is not limited to the following,according to the plastics manufacturer: 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 FreeStyle or FreeStyle 5, they can damage the units’ plastic.

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Clean or replace the air intake / gross particle filter with warm soapy water between eachpatients use. The patients should be instructed to clean this filter at least once per week,
depending on the environment, during normal operation.
Allow the unit to air dry. Then re-test oxygen concentration, test the duration of the battery
pack, and ensure the AC and DC power supplies are in good working condition before you
return the unit to your inventory.
Make the bleach solution a 1:100 dilution of 5.25% sodium hypochlorite. Mix one
part household bleach (e.g., Clorox with 99 parts cold tap water). To measure thesolution easily, take 1/4 cup of household bleach, and mix it with a gallon of cold
tap water. Allow the mixture to sit on potentially contaminated surfaces for ten
minutes.

CAIRE does not recommend the sterilization of this equipment.

RECORDING MAINTENANCE

Whenever maintenance or service is performed on a unit, an entry should be made in theservice log for that concentrator or recorded in accordance with your company’s standard
procedure.

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FreeStyle Serial Number _________________SYSTEM CHECKOUTDATE HOUR METER READING INITIALS SERVICE PERFORMED PURITY ALARMCOMMENTS

Figure 10: Maintenance Log

SERVICE
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TOOLS FOR FREESTYLE AND FREESTYLE 5 SERVICE AND MAINTENANCE

In addition to a pressure test gauge, the following tools are generally readily available forpurchase in your local area, and can assist you in servicing and maintaining the FreeStyle or
FreeStyle 5 unit.

Figure 11.1:.25in hexnut screwdriver andphillips-head screwdriver

Figure 11.2:
5/32-in allen-based driver

Figure 11.3:
Needle-nose pliers and side cutters

Figure 11.4:
Tie-wrap gun

Figure 11.5: Pressure Test Gauge

COMPONENTS
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The design of CAIRE’s FreeStyle and FreeStyle 5 Portable Oxygen Concentrators allows for easy
access and removal of most components. This allows you to perform scheduled maintenanceand to repair and replace parts with minimal time and effort.
For your safety, be sure to disconnect the unit from the AC/DC power outlet
before you service the concentrator.

Remove the battery from the unit before performing any maintenance toprevent accidental electrical shock and burn hazard.

The FreeStyle or FreeStyle 5 must be off and disconnected from external power
before removing the battery pack.

Note all scheduled maintenance. See EQUIPMENT PROVIDER MAINTENANCE
section.

HOUSING REMOVAL
Turn OFF the unit, remove the battery, and disconnect the power cordfrom the electrical outlet before servicing to prevent accidental electricalshock and burn hazard.

Removing Front Cover:
1. Place the unit on its back and position the outlet nozzle upwards facing forward.
2. Locate the three screws securing the front cover (top center, lower left, and lower right).
3. Using a Philips-head screwdriver, loosen and remove the screws.

4. Lift off the front cover.
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Figure 12.1: Removing Front Cover

Removing Back Cover:
1. Place the unit on its front.
2. Locate the four screws securing the back cover.
3. Using a Philips-head screwdriver, loosen and remove the screws.
4. Lift off the back cover.

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Figure 12.2: Removing Back Cover

PSA REMOVAL

Turn OFF the unit, remove the battery, and disconnect the power cordfrom the electrical outlet before servicing to prevent accidental electricalshock and burn hazard.

1. Disconnect the unit from the AC or DC outlet.
2. Remove the battery.
3. Remove the front housing.
4. Disconnect the 8-pin connector (J5 for FreeStyle or J17 for FreeStyle 5) with multi-colored
wires from the circuit board. Care must be taken not to pull on the wires.

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Figure 13.1: J5 8-Pin Connector
5. Remove and discard foam from the top of the oval opening. (See Figure 13.2)

Figure 13.2: Foam Removal

Steps 6 and 7 require extreme caution to ensure the black pressure sensor(U3 for FreeStyle or U9 for FreeStyle 5) is not damaged.

6. Remove the adjustable nozzle by gently pulling it upward until it comes out of the left side
retaining clips. When the left side is out, pull the nozzle to the left to completely remove itfrom its cradle.

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Figure 13.3: Nozzle Removal
7. Carefully disconnect the 1/8” OD tubing coming from the back of the unit to the limiting

orifice.

Figure 13.4: Disconnecting Black Tubing
8. Remove the 8-32 x 1/4” Philips screws located in the center of the outlet nozzle cradle.

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Figure 13.5: Outlet Nozzle Cradle Screw Removal
9. Turn the unit over and remove the back housing.
10. Disconnect the ground wire (connected to the compressor on its upper right side near the
air inlet filter) using a Philips screwdriver.

Figure 13.6: Disconnecting Ground Wire

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11. Disconnect the 1/8” OD tube from the Y-Connector, or T-Connector, that connects to thepressure transducer on the left side (located at the back of the PSA System).
12. For the FreeStyle, remove each tie-wrap around the upper top screw bosses.

Figure 13.7: Tie-wrap Removal
13. Using needle-nose pliers, disconnect all of the valves from the circuit board, carefully noting
where each valve is connected. Do not disconnect by pulling on the wires.

Figure 13.8: Disconnecting the Equalization Valve

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14. Carefully remove the complete PSA assembly from the center housing by pulling it upwards
and slipping the compressor Molex connector through the center section.

Figure 13.9: Removing the PSA Assembly
15. Remove the compressor plate by removing the two screws.

Figure 13.10: Compressor Plate
16. Remove the two mounts from the compressor.

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Figure 13.11: Compressor Mounts

COMPRESSOR REPLACEMENT

The compressor is the “pump” within the oxygen concentrator that pushes room air into thebottom of the sieve beds. Over time, the cup seals may wear and the compressor will not
operate properly. To replace the compressor, follow the steps below:
1. Remove the PSA assembly per the PSA REMOVAL section in this manual.
2. Stand the PSA assembly upright and loosen the center bolt using a 5/32” Allen wrench.

Figure 14.1: Center Bolt of PSA Assembly

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3. Remove the compressor by pulling the compressor away from the PSA assembly.
Care should be taken not to separate the manifold from the beds.

Figure 14.2: Removing the Compressor
4. If either of the two fittings connecting the compressor to the manifold is connected to thecompressor, remove it and insert it back into the manifold.

Figure 14.3: Compressor to Manifold Fittings
5. Connect the new compressor to the PSA assembly, and tighten the bolt to a torque of 15
in-lbs.

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Figure 14.4: Tightening Center Bolt

COMPRESSOR ASSEMBLY INSTALLATION

To install the new compressor assembly, perform the compressor removal procedure in reverse
order.

After replacing the unit’s compressor, you must reset the hour meter. For
a FreeStyle, please reference the HOUR METER FUNCTIONALITY section ofthis manual. If replacing the compressor on a FreeStyle 5, you must referto the instructions for reading and recording hours in the Hour Meter Kit Part Number KI406-1.

PRODUCT MANIFOLD REPLACEMENT

1. Remove the PSA system per the PSA REMOVAL section in this manual.
2. Disconnect the tubing assembly from the barb(s) on the product manifold, mixing tank, andone end of the purge tube.

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Figure 15.1: Manifold Tubing

Figure 15.2: Mixing Tank Tubing

Figure 15.3: Purge Tubing

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3. Remove the tie wraps that bundle the solenoid valve wires together.
4. Loosen and remove the center bolt from the PSA assembly using a 5/32” Allen wrench.

Figure 15.4: Center Bolt Removal
5. Holding the sieve beds in place, gently pull upward on the product manifold to remove.
Keep tubing assembly in place.
6. Align the new product manifold with the outlet of the sieve beds, and gently push the
manifold down into place.
7. Reconnect the tubing assembly to the new product manifold.
8. Place center bolt through the product manifold and tighten to 15 in-lbs.

SOLENOID VALVE REPLACEMENT
Turn OFF the unit, remove the battery, and disconnect the power
cord from the electrical outlet before servicing to prevent
accidental electrical shock and burn hazard.

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It may not be necessary to completely remove the PSA system assembly toreplace the solenoid valve(s). The Feed B/Waste B and OCD valve will
require the PSA system to be partially removed.

1. Remove the back cover panel.
2. Determine which valve needs to be replaced. (Reference the PRESSURE PROFILE andTROUBLESHOOTING sections of this manual for more information)
3. Remove the tie wraps that bundle the valve wires.
4. Carefully disconnect the Molex connector from the circuit board by pulling on the Molex
connector, not the valve wires.
5. Using a small Philips screwdriver, remove the two screws fastening the valve.
6. Remove the valve.
7. Fasten the new valve using the two screws provided.
8. Re-bundle wires and tie-wrap.
9. Start the unit and leak test around the area where the gasket is located on the valve.

SIEVE BED REPLACEMENT
1. Remove the PSA system assembly per the PSA REMOVAL section in this manual.
2. Loosen and remove the center bolt from the PSA assembly using a 5/32” Allen wrench.
3. While holding the adsorbent beds, gently pull up on the product manifold to remove it.

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Figure 16.1: Product Manifold Removal
4. Pull upward on the adsorbent beds to remove them from the feed/waste manifold.

Figure 16.2: Sieve Bed Removal
5. Remove the plugs from the top and bottom of the new adsorbent beds.
6. Place a 1.5mm CS X 6mm ID o-ring on the bottom cap of the adsorbent bed cap.
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7. Place a 1.5mm CS X 3.5mm ID o-ring on the top cap of the adsorbent beds.
8. Align the product manifold with the outlet on the new adsorbent beds and gently pushdown until the o-rings are completely seated.

Figure 16.3: Attaching New Sieve Beds
9. Connect the product manifold to the sieve beds and place the center bolt through the
product manifold then tighten to 15 in-lbs.

Figure 16.4: Attaching Product Manifold
10. Reassemble the unit and leak test at the sieve bed connections.
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FEED/WASTE MANIFOLD REPLACEMENT
1. Remove the PSA system assembly per the PSA REMOVAL section in this manual.
2. Carefully remove the tie wraps that bundle the solenoid valve wires together.
3. Loosen and remove the center bolt from the PSA assembly using a 5/32” Allen wrench.
4. Holding both sieve beds, gently pull upwards, removing the product manifold and sieve
beds. Set the product manifold and sieve bed assembly aside, keeping the top of the sieve
beds connected to the product manifold.

Figure 17.1: Removing the Feed/Waste Manifold
5. Remove the feed/waste manifold by pulling upward on the manifold. Both fittings from the
manifold to the compressor should still be connected to the manifold. If not, remove thefitting(s) from the compressor.

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Figure 17.2: Feed/Waste Manifold with Fittings
6. Place the new feed/waste manifold onto the compressor. Gently push the manifold down
until the compressor fittings are seated into the compressor head.

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MEASURING THE SYSTEM PRESSURE
1. Remove the back cover.
2. Locate the brass fitting with the orange plug on the left side of the feed/waste manifold.
3. Remove the plug.

Orange Plug

Figure 18: Pressure Test Port
4. Using the pressure gauge with 1/8” OD tubing, push tube into the fitting.
5. Turn the unit on by pressing the [2] setting.
6. Make sure that the connections from the pressure gauge to the manifold are leak free.
i. Part No. KI036-1 Pressure Test Kit (gauge and connector) and KI340-1
Adaptor7. Put the unit into test mode (Press the [1] and [3] settings simultaneously for ten seconds if theunit is a FreeStyle. Press the [1] and [5] settings simultaneously for ten seconds if the unit is a
FreeStyle 5). Once the alarm sounds, the LED’s above each flow setting will illuminate. The unit
will then start to automatically pulse. Reference the PRESSURE PROFILES section of this manual
for the pressure swing process.
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PRESSURE PROFILES

The following pressure profiles illustrate the range of normal operating pressures at sea level.
These are approximate pressures. A unit may be out of the range shown below and still bewithin specification, for example, in higher altitude environments.

Figure 19.1: Pressure Profile Quadrant for FreeStyle

Figure 19.2: Pressure Profile Quadrant for FreeStyle 5

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FREESTYLE HOUR METER
General Information
The FreeStyle’s hour meter includes two monitoring channels: a historical channel that cannot
be reset, and a maintenance channel. An onboard, momentary-action pushbutton can be used
to toggle the display between the two channels. The historical channel is generally used tomonitor total operating hours over the life of the FreeStyle unit, while maintenance channel
provides the hours logged between service intervals. While displaying the maintenancechannel, the switch can be used to reset the accumulated maintenance hours to zero.

Hour Meter

ToggleFigure 20: Hour Meter
The FreeStyle 5 does not have an hour meter on the circuit board.
Please reference the FREESTYLE 5 HOUR METER FUNCTIONALITY
section for more information.
Hour Meter Icons
Two LCD icons are used to indicate each mode. In historical mode, an “hour-glass” is displayed toindicate hours. While enabled, the hour-glass will illuminate intermittently. In maintenancemode, both a “TMR1” symbol and an hour-glass are displayed.
Power
When the FreeStyle is connected to AC or DC power, the historical hour meter reading isdisplayed along with the hour-glass icon.
When the FreeStyle is connected to AC or DC power supply, the hour count is displayed, but thetime does not accumulate. When the FreeStyle compressor is started when the unit is turned on,
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the historical hour meter will function. The hour-glass icon will flash to indicate that time is being
accumulated.
Toggle/Reset Switch
This switch (showing in Figure 20) toggles the display or resets the maintenance channel
depending on the activation time and the current display mode.
Upon power-up, the display defaults to the historical display mode. The display will remain inhistorical mode until the pushbutton is used to toggle the display into maintenance mode. The
hour meter will remain in this mode until toggled or until power is removed. The hour-glass
icon will remain on and the “TMR1” icon will be displayed below the hour-glass icon. As withthe historical display mode, the hour-glass icon will flash to indicate that time is being
accumulated and the TMR1 icon will remain on solid. The historical channel cannot be reset. To
reset the maintenance channel, begin with the module in maintenance mode, and then press
the toggle/reset switch for five seconds. A reset is indicated by a “0” display.

HOUR METER REPLACEMENT FOR FREESTYLE ONLY
When removing the front cover to replace the hour meter on a
FreeStyle, always use an ESD safe-work area. Also, use an ESD wrist
strap to protect electronic circuitry.

1. Remove the front cover housing per the HOUSING REMOVAL section of this manual.
2. Ensure that all power sources are disconnected.
3. Locate the hour meter (shown in Figure 20).
4. Using a small Philips head screw driver, remove the 2 screws.
5. Gently pull upward to remove the hour meter from the 8-pin connector (J3). Whenremoving, take care not to bend or break any pins on the J3 connection header.
6. Replace hour meter.

FREESTYLE 5 HOUR METER FUNCTIONALITY

The Freestyle 5 logs the hours of use on the internal circuit board. An interface kit can be purchasedthat allows you to retrieve this hour reading. The Hour Meter Kit can be ordered through CAIRE
Customer Service (1-800-482-2473) by using PN KI406-1.
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The Hour Meter Kit software allows you to read the total number of hours for the unit as well as theability to access a resettable hour counter for service purposes. This can be used to keep records as towhen a component, such as the compressor, was last replaced. The software also allows you to easily
reset the second hour meter by selecting the "Clear" button.
The FreeStyle 5 does not have an “hour meter” like the FreeStyle, but the unit itself will display the
number of hours that it has been in operation on the flow display LEDs. The procedure to enter "TimeReading Mode" is listed below:
1. Turn the FreeStyle 5 on and wait until the startup tone is complete.
2. Press and hold the 1 and 3 buttons for three seconds to enter the Time Reading Mode. Once in thismode, all 5 LEDs will light up and the unit will beep.
3. After the unit has entered this mode, the hours will be displayed in the following manner:
1. Flow Setting LED 1 will display the digit in the ones place.
2. Flow Setting LED 2 will display the digit in the tens place.
3. Flow Setting LED 3 will display the digit in the hundreds place.
4. Flow Setting LED 4 will display the digit in the thousands place.

MOTOR CONTROLLER BOARD REPLACEMENT
When replacing the motor controller circuit board, always use an
ESD safe-work area. Also, use an ESD wrist strap to protect
electronic circuitry.

1. Remove the front cover housing per the HOUSING REMOVAL section of this manual.
2. Ensure that all power sources are disconnected.
3. Lift the motor controller board from the circuit board, being careful not to break theconnector pins while gently rocking it back and forth to loosen and disconnect.

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Figure 21.1: Removing Motor Controller Board
4. Before replacing the board, ensure that the main circuit board and all pins are straight andunbroken (intact).
5. Locate the composite side marked “top”, or the side with the single row connector, andproperly align the connections.

Figure 21.2: Aligning Pins to the Connection

6. View the replacement board from the side and at an angle to make certain that the pins arealigned properly before seating the connector.
7. When the replacement board is properly aligned, gently press the board into place until
properly seated.

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CIRCUIT BOARD REPLACEMENT
Turn OFF the unit, remove the battery, and disconnect the power
cord from the electrical outlet before servicing to prevent
accidental electrical shock and burn hazard.

When replacing the circuit board, always use an ESD safe-workarea. Also, use an ESD wrist strap to protect electronic circuitry.

1. Remove the front and back covers per the HOUSING REMOVAL section of this manual.
2. Remove the inlet screen.
3. Remove the PSA system per the PSA REMOVAL section of this manual.
4. Remove the DC power input connector from the J11 (for FreeStyle) or J13 (for FreeStyle 5)location on the circuit board.

Figure 22.1: J11 Connection
5. Disconnect the control panel/keypad flex circuit from the Ziff (zero insertion force)
connector by carefully lifting upward on the locking tab. This connection is J8 for the
FreeStyle and J9/J10 for the FreeStyle 5.
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Figure 22.2: Disconnecting Flex Circuit
6. Turn the unit over so that the main circuit board is facing upwards.
7. Remove the motor controller board per the MOTOR CONTROLLER BOARD REPLACEMENT
section of this manual.
8. If replacing the circuit board on a FreeStyle, remove the hour meter per the HOUR METERREPLACEMENT section of this manual.
9. Remove the cannula nozzle tuning by cutting the tie wrap (use small-size cutter). Carefully
pull the tubing from the nozzle barb.

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Figure 22.3: Cannula Nozzle Tubing
10. Disconnect the fan wire from the main circuit board by using needle-nose pliers andcarefully pulling upwards on the connector housing on the main circuit board. Connection
J6 for the FreeStyle or connection J15 for the FreeStyle 5.
11. Remove the 4-20 self-tapping screws from the main circuit board. There are 6 screws on the
FreeStyle and 8 screws on the FreeStyle 5.

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Figure 22.4: Self-Tapping Screws
12. Remove the main circuit board from the center section assembly.

Figure 22.5: Main Circuit Board Removal
13. Replace the main circuit board; reverse order of steps 1-13 of this section.
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CONTROL PANEL / KEY PAD REPLACEMENT
When replacing the control panel/key pad, always use an ESD
safe-work area. Also, use an ESD wrist strap to protect electronic
circuitry.
1. Remove the front and rear cover per the HOUSING REMOVAL section of this manual.
2. Remove the PSA system per the PSA REMOVAL section of this manual.
3. Remove the control panel/keypad flex circuit from the Ziff (zero insertion force) connector
by carefully lifting upward on the locking tabs. This is connection J8 for the FreeStyle andconnection J9/J10 for the FreeStyle 5.
4. Remove the flex tab circuit from the rib guides, and peel off the control panel/keypad fromthe center enclosure.
5. Replace control panel/keypad with the new control panel / keypad.
6. Check recessed area of enclosure center section to ensure that the plastic is clean.
7. Remove the adhesive backing and seal backing from the new control panel/key pad.

Figure 23.1: New Control Panel

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8. Carefully align the new control panel/keypad with the recessed control panel area, andpress the control panel/keypad evenly to ensure that all adhesive is in contact with theplastic surface.

Figure 23.2: Adhering New Control Panel
9. Route the flex circuit through the control panel/keypad slot.

Figure 23.3: Control Panel Flex Circuit Slot
10. Bend the flex circuit 180 degrees, being careful not to crease or fold the flex circuit.
If creased or folded, the flex circuit will be damaged.

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Figure 23.4: Bending the Flex Circuit
11. Insert the flex circuit into the rib section and connect the flex circuit with carbon contacts
facing toward you.
12. Insert into Ziff (zero force insertion) connector(s), making sure that the flex circuit seats into
the connector. Carefully press the Ziff connector locking tab in a downward direction.
Ensure that the latch is seated properly.

Figure 23.5: Connecting the Flex Circuit
13. Re-install the PSA system and housing, and ensure that the control panel functions properly.
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FAN REPLACEMENT
When replacing the fan, always use an ESD safe-work area. Also,use an ESD wrist strap to protect electronic circuitry.

1. Remove the PSA system per the PSA REMOVAL section of this manual.
2. Disconnect the Molex connector from the circuit board to the fan.

Figure 24.1: Fan Molex Connection
3. Remove the four Philips head screws that secure the fan to the center section.

Figure 24.2: Fan Screw Removal
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4. When installing a new fan, be sure the arrow on the side of the fan is pointing outwards
toward the front cover. This arrow indicates the direction of the airflow of the fan. For the
FreeStyle, ensure the two wires coming from the fan are located on the upper left side. For
the FreeStyle 5, ensure the two wires coming from the fan are located on the upper rightside.

Figure 24.3: Replacing the Fan

5. Insert the four screws through each of the four corners of the fan. Secure with nut. DO NOT OVER
TIGHTEN.
6. Connect the Molex connector from the fan to the circuit board.

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TROUBLESHOOTINGGENERAL TROUBLESHOOTING
Before reviewing the Troubleshooting Chart, the following steps may be useful to isolate any
malfunctions:
1. Make sure all filters are clean.
2. Turn the unit on by pressing flow setting [2] if a FreeStyle, or flow setting [3] if a FreeStyle 5.
A brief, continuous alarm sounds to indicate that the unit has been turned on. Allow thecompressor to start-up and run for approximately ten seconds.
3. If a FreeStyle, activate the test mode by pressing flow settings [1] and [3] simultaneously forten seconds. If a FreeStyle 5, activate the test mode by pressing flow settings [1] and [5]simultaneously for ten seconds.
4. Make sure that the unit is leak-free by testing all tubing connections and fittings with leaktesting solution. Protect the circuit board from the solution, and start the leak test at thecompressor, following the air flow of the unit to the oxygen outlet. Repair all leaks bytightening connections and fittings.
5. After five minutes, measure the oxygen concentration.

Review the Troubleshooting Chart that follows to isolate and repair a malfunction:

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Problem

Probable Cause

Solution

FreeStyle does not operate whena pulse flow selection button ispressed.

Battery is discharged.

Power the unit through the DC
outlet, or an AC outlet.

Malfunction.

A continuous alarm sounds andthe (red) alarm light illuminates
continuously.

FreeStyle has not detected abreath for 15 minutes.

Contact your Equipment Provider,and change to another source ofoxygen as necessary.

Check the cannula connection.

Ensure that cannula tubing is notkinked.

Make sure that the cannula ispositioned properly and that you arebreathing through your nose. For
mouth-breathing your clinician may
recommend a chin strap.

Intermittent alarm condition, andthe (yellow) BATT lightilluminates intermittently.

Battery requires charging.

Connect to a DC or an AC outlet
within 2 minutes, or exchange
battery packs for a fully charged
pack.

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Rapid alarm condition, and the(yellow) BATT light illuminatesintermittently and FreeStyle
shuts down.

Battery pack charge is too low to Connect to DC or an AC outlet
operate the FreeStyle unit.
immediately.

Intermittent alarm condition, and Breathing rate has exceeded thethe (red) alarm light illuminatescapacity of the FreeStyle unit.
intermittently.

Reduce activity, and then turn unit
off and back on again to reset unit. If
necessary, change to another sourceof oxygen as available and contact
your Equipment Provider.

Intermittent alarm condition, and A general malfunction has
the (red) alarm light illuminates
occurred.
continuously.

Change to another source of oxygen
as available, and contact yourEquipment Provider.

Unit does not start on battery
pack power.

Unit may be hot or cold if left
outdoors such as in an
automobile.

Allow the unit to reach normal
operating temperature, which may
take several minutes if exposed totemperature extremes. Remove thebattery pack and re-install it to reset
the battery pack.

Delay in recharging battery.

Battery exceeds charging
temperature.

Unit may be operated; however,charging may not resume until
battery temperature is reduced.

Unit alarms while in automobileand connected to the DC outlet.

No power to the unit if battery
depleted and DC outlet not
charging.

Disconnect the power supply fromthe automobile outlet, restart the
automobile, and then reconnect thepower supply into the automobile

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DC outlet to reset the breaker within
DC power supply.
For FreeStyle Only:
No hour meter display.
All other problems.

Defective hour meter.

Replace hour meter.
Change to another source of oxygen
as available, and contact yourEquipment Provider.

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ACCESSORIESFor proper performance and safety, use only these listed accessories supplied by CAIRE. Use ofaccessories not listed below could adversely affect the performance and/or safety of theconcentrator.

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CAIRE INC. CUSTOMER SERVICE CONTACT INFORMATION
If you need any additional assistance, contact CAIRE Inc.:
By mail:
CAIRE, Inc.
2200 Airport Industrial Drive, Suite 500
Ball Ground, GA 30107 USA
By telephone: 800.482.2473

CAIRE, Inc.
2200 Airport Industrial Drive, Suite 500
Ball Ground, GA 30107 USA
www.caireinc.com

CAIRE and CAIRE Inc. are registered trademarks of CAIRE Inc.
Please visit our website below for a full listing of trademarks.
Trademarks: www.caireinc.com/corporate/trademarks/.

“Copyright © 2020 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its products, or change the prices, materials,

equipment, quality, descriptions, specifications and/or processes to its products at any time without prior notice andwith no further obligation or consequence. All rights not expressly stated herein are reserved by us, as applicable.”

9 July 2020

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