Patient Manual FreeStyle™ 5 Portable Oxygen Concentrator
DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS, CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTING TO USE THIS EQUIPMENT; OTHERWISE, INJURY OR DAMAGE MAY RESULT. Smoking while using oxygen is the number one cause of fire injuries and related deaths. You must follow these safety warnings: Do not allow smoking, candles, or open flames in the same room with the device or within 5 feet (1.
TABLE OF CONTENTS AirSep® FreeStyle™ 5 Portable Oxygen Concentrator AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator 1 Symbols 1-2 Why Your Physician Prescribed Oxygen 2 What is the FreeStyle 5 Portable Oxygen Concentrator? 3 Operator Profile 3 Important Safety Rules 4-9 Important Safety Rules for Optional AirBelt 9-10 Getting Started with Your FreeStyle 5 Portable Oxygen Concentrator 11-12 Battery Charging 13-15 Nasal Cannula 16 FreeStyle 5 Unit Components 17 Operating Instructions
TABLE OF CONTENTS AirSep® FreeStyle™ Portable Oxygen Concentrator Alarm/Light Indicators 21-22 How to Respond to FreeStyle 5’s Alarm/Light Indicators 23 Cleaning, Care, and Proper Maintenance 24 Cabinet 24 Filter 25 Carrying Bag 25 FreeStyle 5 Accessories 26 Materials in direct or indirect contact with the patient 27 Reserve Oxygen Supply 27 Troubleshooting 27-29 FreeStyle 5 Specifications 30-33 Classification 34 Limited Warranty 35
AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator This Patient Manual will acquaint you with AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator (POC). Make sure you read and understand all of the information contained in this manual before you operate your FreeStyle 5 unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
No Smoking Do not disassemble Type BF Equipment Consult instructions for use This side up RTCA/DO-160 Section 21 Category M Compliant Fragile – handle with care Do not expose to open flames FAA – Approved POC RTCA DO160 Section 21 Category M Compliant. FAA SFAR 106 requirement See Instructions Method of disposing of waste: All waste from AirSep’s FreeStyle 5 Oxygen Concentrator must be disposed of using the appropriate methods specified by local authorities.
What is the FreeStyle 5 Portable Oxygen Concentrator? Oxygen concentrators were introduced in the mid-1970’s and have become the most convenient, reliable source of supplemental oxygen available today. Oxygen concentrators are the most cost-effective, efficient, and safest alternative to using high-pressure oxygen cylinders or liquid oxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottle deliveries required.
FreeStyle 5 for Airline Travel – FAA-Approved FreeStyle has received the US Federal Aviation Administration’s (FAA) acceptance for onboard in-flight use by oxygen passengers on commercial airlines via a 2012 amendment to SFAR 106.
The incorrect use of the FreeStyle 5 battery can cause the battery to get hot, ignite, and may cause serious injury. Be sure not to pierce, strike, step on, or drop the battery, or otherwise subject the battery to strong impacts or shocks. While using the FreeStyle 5 outdoors with the AC power supply, connect the power supply into a Ground Fault Interrupted (GFI) outlet only. Electrical shock hazard.
The FreeStyle 5 Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician. Operating the FreeStyle 5 unit outside of its normal operating temperature range can affect performance and decrease battery run time and/or increase battery charge time. (Refer to the Specifications section in this manual.) Do not allow either the air intake or the air outlet vents to become blocked. This can cause the FreeStyle 5 unit to overheat and affect performance.
Replace the disposable cannula as recommended by the manufacturer or your equipment provider. Additional supplies are available from your Equipment Provider. Do not position the Concentrator so that it is difficult to access the power cord. The concentrator should be located as to avoid pollutants or fumes. Cannula tubing must be non-kinking, which can be used for a total length of up to 25 ft (7.6 m) maximum. Ensure the cannula is fully inserted and secure.
When connected to AC or DC power, the unit’s battery charges until it reaches full capacity, either while the unit is operating or turned off. If the internal battery fully depletes and the FreeStyle 5 unit shuts down, the unit cannot be restarted with the AirBelt. Should this occur, connect your FreeStyle 5 to its AC or DC power supply for a short period of time in order to provide sufficient internal battery power to start the unit. AirBelt can then be connected to provide additional run time.
The lithium ion rechargeable battery that is used in the FreeStyle 5 unit does not need to be fully depleted before recharging. It is recommended to charge the battery regardless of the battery’s capacity level after use. The battery will charge when the unit is off as well as while the unit is running off the AC or DC power supply. Lithium batteries may permanently lose capacity when exposed to extremely hot temperatures with the batteries fully charged or completely depleted.
AirBelt does not need to be fully discharged before recharging. It is recommended to charge AirBelt after each use. Lithium batteries may permanently lose capacity when exposed to extremely hot temperatures with the batteries fully charged or completely depleted. For extended storage, it is recommended that batteries be charged 25 to 50% and remain within a temperature range of 73° F (23° C) +/- 2°C.
[Read the Important Safety Rules section before operating this equipment.] Getting Started with Your FreeStyle 5 Portable Oxygen Concentrator The FreeStyle 5 packaging contains the following items, as shown in Figures 1-3. If any are missing, contact your Equipment Provider. FreeStyle 5 Portable Oxygen Concentrator with carrying case. Patient manual (not shown) AC power supply (100-240 volts, 50/60 Hz) with power cord.
All AirBelt Warnings, Cautions and Notes should be read first before proceeding with your equipment. See pg 9, "Important Safety Rules for Optional AirBelt". Other optional accessories include a harness to easily convert the FreeStyle 5 carrying bag to a backpack (part number MI2841), as shown in Figure 5. The FreeStyle 5 can also be worn on the waist if desired by feeding the AirBelt or other belt you are wearing throught the loops on the FreeStyle 5 carrying case. (See Figure 6.
Battery Charging Check to make sure your unit’s battery is fully charged before venturing out with FreeStyle 5 for the first time or upon subsequent use. To check the level of charge of the internal battery, press the BATT button on FreeStyle 5’s keypad. The battery gauge/indicator(s) LEDs above the BATT button illuminate to indicate the level of internal battery charge (25-100%). Note: The internal battery is charging whenever the unit is operating on AC or DC power.
Charging the Optional AirBelt To charge the AirBelt battery for extended use: 1) Release safety cap from end of the AirBelt cord (see figure 4). 2) Connect the AC/DC power supply (included with AirBelt Accessory kit) to the end of AirBelt’s power cord, as shown in Figure 9. 3) Connect the AirBelt power supply to an AC electrical outlet to recharge.
Depending upon the temperature of the AirBelt, it can take several minutes for the charging cycle to start after connecting to power. This is a normal condition and is intended for safe charging. AirBelt does not need to be fully discharged before recharging. It is recommended to charge it after each use.
---- [Read the Important Safety Rules section before operating this equipment.] ---Nasal Cannula A nasal cannula and tubing are used to deliver oxygen from the FreeStyle 5 unit to the user. The tubing is connected to the unit’s oxygen outlet (See Figure 10). Figure 10: Connecting Cannula to FreeStyle 5’s Oxygen Outlet AirSep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No. CU002-1. Other lengths of tubing up to 25 ft (7.6 m) maximum, including nasal cannula, may be used.
FreeStyle 5 Unit Components Alarm Indicator Dust Cover Pulse Flow Indicator(s) Handle Battery Gauge/ Indicator(s) Flow Selection Button(s) (Internal) Battery Button Air Outlet Oxygen Outlet Air Outlet Figure 12: Close-Up of Keypad/Alarm Display Inlet for Power Connections Air Intake/Filter Cover Figure 11: FreeStyle 5 Exterior View - Front Label/Patient Instructions Figure 13: FreeStyle 5 Exterior View - Back Now that you are familiar with FreeStyle 5’s components, review the instructions on t
[Read the Important Safety Rules section before operating this equipment.] Operating Instructions 1. Locate and position the FreeStyle 5 so that the air inlets and air outlets are not obstructed. 2. Power the unit from (a) the internal battery; (b) AirBelt; (c) DC outlet (i.e. automobile or motor boat); or (d) an AC outlet (i.e. normal household electric). (Refer to the Power Supplies section of this Patient Manual.
[Read the Important Safety Rules section before operating this equipment.] Power Supplies FreeStyle 5 can be powered in four different ways – the internal battery, an AC power supply, DC power supply, and an optional AirBelt battery belt in combination with the unit’s internal battery. 1. Internal Battery: A rechargeable internal battery is located within each FreeStyle 5 unit. When it is fully charged, it supplies power to the FreeStyle 5 unit for up to 3 hours.
Filters Air enters FreeStyle 5 through an air intake filter located under the cover on the lower front of the oxygen concentrator. (See Figures 14 and 15.) This filter prevents dust and other large particles in the air from entering the unit. Before you operate FreeStyle, make sure this filter is clean and positioned correctly.
Setting of the Flow Selector The FreeStyle 5 unit has five pulse flow settings: 1, 2, 3, 4, and 5, providing flows equivalent to 1-5 LPM oxygen. Lift the dust cover on the unit’s keypad, and press the 1, 2, 3, 4, or 5 button, which corresponds to the oxygen pulse flow that your physician has prescribed. (See Figures 16 and 17.) Figure 16: Lifting Dust Cover on Keypad Display Figure 17: Pressing Flow Selection Button It is very important to select only the prescribed level of oxygen.
An audible alarm sounds if FreeStyle 5 has a low battery, if the cannula is disconnected, or if performance of the unit is outside specifications. The light and audible alarm conditions are explained in detail below and summarized on the chart later in this section of the manual. In the event of an alarm or you observe FreeStyle 5 is not working properly; consult the Troubleshooting section in this manual. If you cannot resolve the problem, consult your Equipment Provider.
This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable to communicate discomfort while using this unit may require additional monitoring. Patients with hearing and/or sight impairment(s) may need assistance with monitoring alarms.
Dual display: Alarm condition (yellow) General malfunction (red) Figure 16: Alarms Indicator Cleaning, Care, and Proper Maintenance Cabinet Turn off the FreeStyle 5 unit, and disconnect the power cord from FreeStyle 5 before you clean the cabinet. Do not use liquid directly on the FreeStyle 5 unit to clean it.
To prevent a voided AirSep warranty, follow all manufacturers’ instructions. F Filter Air Intake Filter At least one time each week, remove the cover on the lower front of the unit, and wash the air intake filter, which is positioned on the inside of the cover. (refer to filter section of this manual) Your Equipment Provider may advise you to clean it more often, depending upon your operating conditions. Follow these steps to properly clean the air intake filter: 1.
FreeStyle 5 Accessories In addition to the nasal cannula, AirSep recommends that you do not use accessories with FreeStyle 5 other than those listed below as supplied by AirSep through your Equipment Provider. Use of accessories not listed below could adversely affect the performance and/or safety of the FreeStyle 5 Portable Oxygen Concentrator. Part Number / Description PW021-1 AC Power Supply (PW021 cord length 4 ft-6 in / 1.4m) w/ CD023-1 Power Cord 120VAC (8 ft / 2.
Materials in direct or indirect contact with the patient o Concentrator casing …………………..…Valtra/ABS/Polystyrene o Concentrator Control Panel…………..….Polyester EBG7 or equivalent o Control Panel Door ……………………….Polycarbonate o Concentrator Handle .…………………… Polycarbonate o Gas Outlet, Nozzle …………………..……Polycarbonate o Air intake filter ……………………………..Foam, Polyester o Unit Label …………………………..…….. Lexan o Unit feet ……………………………………Polyurethane o Cord connectors ……………………..…...
Problem Probable Cause Solution FreeStyle 5 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. Malfunction. Contact your Equipment Provider, and change to another source of oxygen as necessary. FreeStyle 5 has not detected a breath for 15 minutes. Check the cannula connection. A continuous alarm sounds and the (yellow) alarm light illuminates intermittently. Ensure that cannula tubing is not kinked.
Problem Probable Cause Solution Intermittent alarm condition, and the (yellow) alarm light illuminates intermittently. Breathing rate has exceeded the capacity of the FreeStyle 5 unit. Reduce activity, and then turn unit off and back on again to reset unit. If necessary, change to another source of oxygen as available and contact your Equipment Provider. Rapid intermittent alarm condition, and the (red) alarm light illuminates continuously. A general malfunction has occurred.
FreeStyle 5 Specifications Oxygen Concentration:* 1-5 pulse settings; equivalent to a continuous flow of 90% oxygen +5.5 / -3% Pulse Dose: Setting 1: 8.75ml ± 15% Setting 2: 17.5ml ± 10% Setting 3: 26.5ml ± 10% Setting 4: 35.0ml ± 10% Setting 5: 43.75ml ± 10% 10.7 in. high x 6.6 in. wide x 4.4 in. deep (27.2 cm high x 16.8 cm wide x 11.
“Specifications continued” Medical equipment needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in this section. Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle 5 should assure that it is used in such an environment.
Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle 5 should assure that it is used in such an electromagnetic environment.
Recommended separation distances between portable and mobile RF communications equipment and the FreeStyle 5 The FreeStyle 5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Classification Type of protection against electric shock: Class II Protection from electric shock is achieved by double insulation. Degree of protection against electric shock: Type 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.
Limited Warranty AirSep Corporation warrants the FreeStyle 5 Oxygen Concentrator to be free from defect in parts for three years (as specified on the original invoice provided) from the date of delivery to the original purchaser, under normal use and operation. The battery is warranted for one year.
For European representative: Gavin Ayling 9 Bungham Lane Penkridge Stafford Staffordshire ST19 5NH England E-mail: eurorepcontact@airsep.
