User Manual FreeStyle™ & FreeStyle™ 5
Contents User Controls & System Status Indicators..............................................3 What is the Oxygen Concentrator...........................................................4 Why Your Physician Prescribed Oxygen................................................4 Operator Profile.......................................................................................5 Unpacking Your FreeStyle or FreeStyle 5..............................................
User Controls & System Status Indicators Symbol Definition Symbol Definition Consult instructions for use Do not disassemble No Smoking Icon: Do not smoke near unit. Use no oil or grease. This side up No open or naked flames. RTCA/DO-160 Section 21 RTCA DO160 Section 21 Category M Category M Compliant. FAA SFAR 106 requirement Compliant Safety agency for CAN/CSA C22.2 No. 60601-108 M90 for medical electrical equipment Fragile – handle with care Safety agency for CAN/CSA C22.2 No. 601.
What is the Oxygen Concentrator The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gasses. In the FreeStyle and FreeStyle 5, room air is drawn into the machine through the air intake. It then passes through an adsorbent material called “molecular sieve”. This material separates the oxygen from the nitrogen and allows only the oxygen to pass through. The result is a flow of high-concentration oxygen delivered to the user.
Operator Profile Concentrators are intended to supply supplemental oxygen to users suffering from discomfort due to ailments which effect the efficiency of ones lungs to transfer oxygen in the air to their bloodstream. Portable oxygen concentrators (POCs) do not store or contain oxygen. They do not need to be refilled, and can recharge anywhere AC or DC power is available.
Getting to Know Your FreeStyle or FreeStyle 5 Become familiar with the key features of the FreeStyle and FreeStyle 5 and their control panels Handle Control Panel Oxygen Outlet Air Outlet(s) Inlet for Power Connections Battery Pack Air Intake/Filter Cover 6 — MN218 B Battery Pack Release Button
Alarm Indicator Light Battery Gauge Indicator Lights Pulse Flow Indicator Battery Status Button Flow Selection Buttons Flow Selection Buttons: Battery Status Button: To power the device ON or OFF, press the numeric button of your prescribed pulse flow setting. The Pulse flow indicator light will illuminate green above the selected flow setting when the unit is ON. You can also change flow settings by pressing the numeric button of the desired setting.
Important! Safety Instructions are defined as follows: WARNING: IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT CAUSE SERIOUS INJURY. CAUTION: Important information for preventing damage to the FreeStyle or FreeStyle 5. Note: Information needing special attention. Indications for Use WARNING: 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.
WARNING: IF THE OXYGEN CONCENTRATOR HAS BEEN DROPPED, DAMAGED OR EXPOSED TO WATER PLEASE CONTACT YOUR HOME CARE PROVIDER FOR INSPECTION OR POSSIBLE REPAIR OF THE DEVICE. DO NOT USE THE OXYGEN CONCENTRATOR IF IT HAS A DAMAGED POWER CORD OR PLUG. WARNING: PROPERLY SECURE, BELT OR OTHERWISE RESTRAIN THE OXYGEN CONCENTRATOR WHEN IN A VEHICLE DURING TRANSPORT TO PREVENT DAMAGE OR INJURY.
CAUTION: In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the Troubleshooting section in this manual. If you cannot resolve the problem, consult your Equipment Provider. CAUTION: To prevent a void warranty, follow all manufacturers’ instructions. WARNING: DO NOT ATTEMPT ANY MAINTENANCE OTHER THAN THE POSSIBLE SOLUTIONS LISTED WITHIN THIS MANUAL.
CAUTION: Always disconnect AC power supply from the wall before disconnection the AC power supply from the oxygen concentrator. CAUTION: Do not position the Concentrator so that it is difficult to access the power cord. CAUTION: Always place oxygen supply tubing and power cords in a manner that prevents trip hazard or possible accidental strangulation.
Specifications Dimensions Weight (w/ Battery Pack) Nominal Sound Level Flow Settings Oxygen Concentration FreeStyle FreeStyle 5 8.6 in x 6.1 in x 3.6 in 10.7 in x 6.6 in x 4.4 in (21.8 cm x 15.5 cm x 9.1 cm) (27.2 cm x 16.8 cm x 11.2 cm) 4.9 lbs (2.2 kg) 6.7 lbs (3.0 kg) 41 dB(A) at setting 2 48 dB(A) at setting 3 44 dB(A) at setting 3 51 dB(A) at setting 5 Pulse Settings 1, 2, 3 Pulse Setting 1, 2, 3, 4, 5 90% oxygen +5.5/-3% 90% oxygen +5.5/-3% AC Power 100-240 VAC, 50-60 Hz (1.
Operating Instructions 1 Locate and position the FreeStyle or FreeStyle 5 in a proper location for use. a The concentrator should be well-ventilated so that they air intake and air outlets are not be obstructed. b The concentrator should be positioned so that all audible and visual indicators and alarms can be easily seen and heard. c Be sure the air intake filter and filter cover are in place before operating the unit. If the unit is missing the filter or filter cover, contact your equipment provider.
5 Turn on the FreeStyle or FreeStyle 5 by pressing the numeric flow selection button of the pulse flow setting prescribed by your physician to turn on the device. A brief audible alarm will sound to indicate the device has powered on and the green light above the flow selection button you pressed should remain illuminated. 6 Position the nasal cannula on your face per the manufacturer’s instructions provided with the cannula and breathe normally.
Power Supplies The FreeStyle and FreeStyle 5 can be powered in 3 ways: • Re-chargeable Battery Pack • AC Power • DC Power Information on the operation of each of these components is in the following sections. WARNING: USE ONLY THE POWER SUPPLIES OUTLINED IN THIS USER’S MANUAL. USE OF NON-CAIRE POWER SUPPLIES AND BATTERY PACKS CAN CAUSE DAMAGE TO THE UNIT AND IMPROPER OPERATION. REMOVING THE BATTERY: Pull the battery release button outward away from the FreeStyle or FreeStyle 5.
To check the battery charge when it is not installed in the FreeStyle or FreeStyle 5, turn the battery on its back and press the TEST button. The battery gauge indicator lights (25-100%) will illuminate to the right of the TEST button to indicate the level of the battery pack charge. INITIAL CHARGING: The new battery supplied with your FreeStyle or FreeStyle 5 is only partially charged when it is shipped from the factory.
FreeStyle AC & DC Power Supply The FreeStyle is equipped with a universal AC/DC power supply 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 supply includes the following: 1. Universal power supply (brick) which operates on: a. AC Power between 100-240 volts, 5060Hz. b. DC Power sources including 12V automobile accessory outlets 2. Removable AC power cord a.
4. Ensure the green light on top of the Universal power supply is illuminated. This indicates that the power supply is receiving power from the outlet. If the green light is not illuminated, check for secure connections and refer to the troubleshooting section of this manual. 2. Connect the DC power cord to the inlet marked “ACCESSORY DC IN” on the universal power supply 3. Connect the opposite end of the DC power cord to automobile or other DC accessory outlet. 5.
FreeStyle 5 AC & DC Power Supply The FreeStyle 5 is equipped with separate power supplies for AC and DC operation. 2. Connect the AC power cord to the inlet on the power supply. 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 3.
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 5 will also recharge the battery 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. 4. Ensure the green light on top of the DC supply is illuminated. This indicates that the power supply is receiving power from the outlet.
Cleaning, Care & Routine Maintenance ROUTINE MAINTENANCE 2. Remove the filter from the cover. Servicing of internal components inside of the cabinet of the FreeStyle or FreeStyle 5 must be performed by the oxygen provider. The operator is responsible for the following maintenance procedures. • Weekly – Clean the Air Intake Filter WARNING: DO NOT ATTEMPT TO OPEN OR REMOVE THE PLASTIC COVERS OF THE FREESTYLE OR FREESTYLE 5. THE UNIT SHOULD ONLY BE OPENED BY A QUALIFIED SERVICE TECHNICIAN.
may also cause the battery to generate heat, smoke, catch fire, or explode. The battery pack should be stored in a stable environment characterized by low-humidity (less than 70% RH) and free of corrosive gasses. To prevent rust, avoid conditions that can create condensation such as rapid fluctuations in the ambient temperature. For storage of a month or more, a discharged or partial charged state of charge between 50% and 75% (two to three LEDs) is recommended.
Alarm Conditions face, and ensure that you are breathing through your nose. If the alarm continues to sound, change to another source of oxygen as available, and contact your Equipment Provider. START-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.
Troubleshooting Problem Probable Cause Solution FreeStyle does not operate when a pulse flow selection button is pressed. Battery is discharged. Power the unit through the DC outlet, or an AC outlet. A continuous alarm sounds and the (yellow) alarm light illuminates continuously. FreeStyle has not detected a breath for 15 minutes. Malfunction. Contact your Equipment Provider, and change to another source of oxygen as necessary. Check the cannula connection. Ensure that cannula tubing is not kinked.
Travel Information The FreeStyle and FreeStyle 5 are both FAA approved for use on-board commercial aircraft. Prior to any travel (airline, train, cruise, etc.) you should: • Ensure the concentrator is in good operation condition • Contact your carrier at least 48 hours prior to departure to inform them you will be travelling with a FreeStyle or FreeStyle 5. It is suggested to always carry extra batteries with you on trips.
Carrying Bag Instructions To insert and secure your FreeStyle or FreeStyle 5 unit in the carrying bag, utilize the following instructions. SHOULDER STRAP INSTALLATION 1. Unclip the carry handle. INSERTING UNIT INTO CARRYING BAG 1. Insert unit into bottom of bag, properly aligning filters and battery openings. 2. Insert long section into same clip. 2. Secure zipper around bottom of pouch. 3. Attach remaining end to other side of carry handle.
Materials in Direct Contact with the Operator • Concentrator Casing.......................................................................................................................PC/ABS. • Concentrator Control Panel...........................................................................Polyester EBG7 or equivalent • Concentrator Handle..............................................................................................................Polycarbonate • Oxygen Outlet, Nozzle..................
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The FreeStyle and FreeStyle 5 are intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle and FreeStyle 5 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electromagnetic Floors should be wood, concrete or environment – ±6 kV contact ±6 kV contact ceramic tile.
Guidance and Manufacturer’s Declaration–Electromagnetic Immunity The FreeStyle and FreeStyle 5 are intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle and FreeStyle should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the FreeStyle or FreeStyle 5 The FreeStyle and FreeStyle 5 are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Notes FreeStyle & FreeStyle 5 User Manual — 31
CAIRE Inc. 2200 Airport Industrial Dr., Ste 500 Ball Ground, GA 30107 www.CAIREmedical.com Medical Product Services GmbH Borngasse 20 35619 Braunfels, Germany Tel: +49 (0) 6442-962073 E-mail: info@mps-gmbh.eu Worldwide: www.CAIREmedical.com Copyright © 2016 Chart Industries. CAIRE Inc.
