Patient Manual FreeStyle™ Portable Oxygen Concentrator 260 Creekside Drive Buffalo, NY 14228-2085 USA
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 COULD OCCUR. 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 the oxygen-carrying accessories.
TABLE OF CONTENTS AirSep® FreeStyle™ Portable Oxygen Concentrator AirSep’s FreeStyle™ Portable Oxygen Concentrator 1 Symbols 1-2 Why Your Physician Prescribed Oxygen 2 What is the FreeStyle Portable Oxygen Concentrator? 3 Operator Profile 3 FreeStyle for Airline Travel – FAA-Approved 4 Important Safety Rules 5-10 Getting Started with Your FreeStyle Portable Oxygen Concentrator 11-12 Battery Charging 13-14 Nasal Cannula 15 FreeStyle Unit Components 16 Operating Instructions 17-18 Powe
TABLE OF CONTENTS AirSep® FreeStyle™ Portable Oxygen Concentrator Alarm/Light Indicators 26-27 How to Respond to FreeStyle’s Alarm/Light Indicators 28 Cleaning, Care, and Proper Maintenance 29 Cabinet 29 Filter 30 Carrying Bag 31 Alarm/Service Indicator 31 FreeStyle Accessories 32 Materials in direct or indirect contact with the patient 33 Reserve Oxygen Supply 33 Troubleshooting 33-35 FreeStyle Specifications 36-39 Classification 40
AirSep’s FreeStyle™ Portable Oxygen Concentrator This Patient Manual will acquaint you with AirSep’s FreeStyle™ Portable Oxygen Concentrator (POC). Make sure you read and understand all the information contained in this manual before you operate your FreeStyle unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
Symbol Description No Smoking RTCA/DO-160 Section 21 Category M Compliant Symbol Description Do not disassemble Type BF Equipment Consult instructions for use RTCA DO160 Section 21 Category M Compliant. FAA SFAR 106 requirement Safety agency for CAN/CSA C22.2 No. 60601-1-08 M90 for medical electrical equipment This side up Safety agency for CAN/CSA C22.2 No. 601.
What is the FreeStyle Portable Oxygen Concentrator? Oxygen concentrators were introduced in the mid-1970’s and has become the most convenient, reliable source of supplemental oxygen available today. Oxygen concentrators are the most cost-effective, efficient, and safest alternative to using high-pressure oxygen cylinders or liquid oxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottle deliveries required.
FreeStyle for Airline Travel – FAA-Approved FreeStyle has received the US Federal Aviation Administration’s (FAA) acceptance for onboard in-flight use by oxygen passengers on commercial airlines via a 2006 amendment to SFAR 106.
[Read the Important Safety Rules section before operating this equipment.] Important Safety Rules Carefully review and familiarize yourself with the following important safety information about the portable FreeStyle Oxygen Concentrator. “No Smoking – Oxygen in Use” signs must be prominently displayed in the home, or where oxygen is in use. Patients and their caregivers must be informed about the dangers of smoking in the presence of, or while using, medical oxygen.
Do not use liquid directly on the unit. A list of undesirable chemical agents includes but is not limited to the following: 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 Oxygen Concentrator, as they can damage the unit’s plastic.
Contraindications for Use: In certain circumstances, the use of non-prescribed oxygen can be hazardous. This device should only be used when prescribed by a physician. NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANETHETICS. As with any electrically powered device, the user may experience periods of non-operation as a results of electrical power interruption, or the need to have the oxygen concentrator serviced by a qualified technician.
When the automobile in which you are using the Oxygen Concentrator unit is turned off, disconnect and remove the device from the automobile. Do not store the Oxygen Concentrator in a very hot or cold automobile or in other similar, high-or lowtemperature environments. DO NOT leave the Oxygen Concentrator or the Power Supply plugged into the vehicle if the ignition is in the OFF position. Doing so may drain the vehicle’s battery.
Ensure the cannula is fully inserted and secure. This ensures that the Oxygen Concentrator can properly detect inspiration for oxygen delivery. During inhalation, you should hear or feel oxygen flow to the prongs of the nasal cannula. Always follow the cannula manufacturer’s instructions for proper use. Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider. Additional supplies are available from your Equipment Provider.
AirSep offers the OxySafe as an optional accessory. This is intended to be used in conjunction with the FreeStyle concentrator. For customers in regions requiring compliance to EN ISO 8359:1996-Ammendment1:2012, this accessory will meet this need. The OxySafe is a thermal fuse to stop the flow of gas in the event that the downstream cannula or oxygen tubing is ignited and burns to the OxySafe.
[Read the Important Safety Rules section before operating this equipment.] Getting Started with Your FreeStyle Portable Oxygen Concentrator The FreeStyle packaging contains the following items, as shown in Figures 1-3. If any are missing, contact your Equipment Provider. FreeStyle Portable Oxygen Concentrator with carrying case. Patient manual (not shown) Universal AC/DC power supply (100-240 volts, 50/60 Hz) with power cord.
The incorrect use of AirBelt can cause the battery to get hot, ignite, and can cause serious injury. Be sure not to pierce, strike, step on, or drop the battery, or otherwise subject the battery to strong impacts or shocks. All AirBelt Warnings, Cautions and Notes should be read first before proceeding with your equipment. See pg 10, "Important Safety Rules for Optional AirBelt".
Battery Charging Check to make sure your unit’s battery is fully charged before venturing out with FreeStyle for the first time or upon subsequent use. To check the level of charge of the internal battery, press the BATT button on FreeStyle’s keypad. The battery gauge/indicator(s) LEDs above the BATT button illuminate to indicate the level of internal battery charge (25-100%). Note: The internal battery is charging whenever the unit is operating on AC or DC power.
Charging of the battery may take several minutes after connecting the power to initiate, depending on the battery’s internal operating temperature. This is a normal condition and is intended for safe battery charging. This circumstance is more likely when the battery has been fully discharged. If the device power supply remains connected when the battery is fully charged, the four LEDs will turn off within approximately 1 hour.
[Read the Important Safety Rules section before operating this equipment.] Nasal Cannula A nasal cannula and tubing are used to deliver oxygen from the FreeStyle unit to the user. The tubing is connected to the unit’s oxygen outlet (See Figure 9). Figure 9: Connecting Cannula to FreeStyle’s Oxygen Outlet AirSep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No. CU002-1. Other lengths of tubing up to 25 ft (7.6 m) maximum, including nasal cannula, may be used.
FreeStyle Unit Components Dust Cover Alarm/Service Indicator Pulse Flow Indicator(s) Battery Gauge/ Indicator(s) Flow Selection Button Handle (Internal) Battery Button Oxygen Outlet Air Outlet Air Outlet Figure 11: Close-Up of Keypad/Alarm Display Inlet for Power Connections Air Intake/Filter Cover Figure 10: FreeStyle Exterior View - Front RTCA DO160 indicates that FreeStyle unit has been tested and approved to comply with FAA standards.
[Read the Important Safety Rules section before operating this equipment.] Operating Instructions 1. Locate and position the FreeStyle 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.) 3. Connect your cannula to the oxygen outlet. 4. Lift the dust cover on the unit. 5.
Operating outside of the operational specifications can limit the concentrator's ability to meet Oxygen Concentration specification. Refer to the specifications section of this manual for storage and operating temperature limits. The Oxygen Concentrator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is unavoidable, the device should be observed to verify normal operation. No modification of this equipment is permitted.
Power Supplies FreeStyle can be powered in four different ways – the internal battery, a Universal AC/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 unit. When it is fully charged, it supplies power to the FreeStyle unit for up to 3 ½ hours. An audible alarm sounds when the battery power is getting low.
FreeStyle™ Universal AC/DC Power Supply (Instructions for use) Connections for removable AC or DC power cord Connects to FreeStyle unit Figure 13 AirSep’s new universal power supply for the FreeStyle Portable Oxygen Concentrator (POC) is an all-in-one way to keep you fully powered, yet traveling even lighter – wherever you go.
Start with the Universal AC/DC Power Supply and FreeStyle Connection For all procedures below, it is recommended that you first connect the universal power supply to the FreeStyle POC inlet, as shown in Figure 14. Be sure to properly connect to the unit by ensuring that the carrying case alignment with the FreeStyle unit inlet allows you to obtain a secure connection so that the cord “locks” in place.
Caution: When using FreeStyle with the universal power supply in an automobile, boat, or other motor vehicle, make sure that the vehicle is started and running before turning on and operating the FreeStyle unit. If the power supply indicator light does not illuminate and requires resetting, disconnect the power supply from the motor vehicle’s DC outlet, restart your vehicle, and then reconnect your power supply into the DC outlet. 1.
1. 2. 3. 4. 5. Make sure your power supply is securely connected to the FreeStyle inlet, as shown in Figure 14. Connect the proper DC power cord end to the ACCESSORY DC IN inlet on the power supply, as shown in Figure 19. Remove the tip of the DC connector by pressing on the tab to expose the 4-pin connector, as shown in Figure 20. Insert the 4-pin connection to the airline passenger DC outlet optionally available at your seat.
Filters Air enters FreeStyle through an air intake filter located under the cover on the lower front of the oxygen concentrator. (See Figures 21 and 22.) 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. Figure 21: Removal of Air Intake Filter Cover Figure 22: Removal of Filter from Filter Cover Do not operate the Oxygen Concentrator without the air intake filter in place.
Setting of the Flow Selector The FreeStyle unit has three pulse flow settings: [1], [2], and [3], providing flows equivalent to 1-3 LPM oxygen. Lift the dust cover on the unit’s keypad, and press the [1], [2], or [3] button, which corresponds to the oxygen pulse flow that your physician has prescribed. (See Figures 23 and 24.
Alarm/Light Indicators When the FreeStyle unit senses inhalation, a pulse of oxygen is sent through the nasal cannula. The green light above the selected pulse flow setting displays intermittently each time a breath is detected. Additionally, when the unit is operating on and simultaneously being charged through the Universal AC/DC power supply, the FreeStyle unit’s battery gauge/indicator(s) display the charge level of the battery and remain on for approximately one hour after reaching a full charge.
o Cannula disconnected When FreeStyle is operating but does not sense breathing, a constant alarm sounds, and the alarm light illuminates after 15 minutes. If this occurs, check the connection from the cannula to the FreeStyle unit, make sure that the nasal cannula is positioned properly on your face, and ensure that you are breathing through your nose. (Your physician may recommend the use of a chin strap if needed.
How to Respond to FreeStyle’s Alarm/Light Indicators Status Light Indicates Action Brief, continuous at start–up (Green) pulse; continuous light FreeStyle has been turned on You may begin to operate your FreeStyle unit. No (Green) pulse; intermittent light FreeStyle is delivering oxygen as a pulse flow. Continue using FreeStyle normally. Indicator No Level indicator Battery charge level. Charge as indicated. Indicator No (Yellow) continuous light Service required.
Cleaning, Care, and Proper Maintenance Cabinet Electrical shock hazard. Turn OFF the unit and disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock and burn hazard. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit. Care should be taken to prevent the Oxygen Concentrator and the battery from getting wet or allowing fluids to enter the unit.
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. 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. Remove the filter from the air intake filter cover, and wash it in a warm solution of soap and water. 2.
Carrying Bag To clean the carrying bag and strap, brush only with warm soapy water (do not saturate the bag), then allow to air dry. Do not machine wash or dry the bag. Dual display Service Required (yellow) Alarm Condition (red) Figure 25: Indicator of Required Inspection/Service *Alarm/Service Indicator When the alarm service/indicator illuminates (yellow), it is time for your FreeStyle unit to be inspected/serviced by your Equipment Provider.
FreeStyle Accessories For proper performance and safety, use only these listed accessories supplied by AirSep through your Equipment Provider.
No modification of this equipment is permitted. Use of cables and adapters other than those specified, with the exception of cables and adapters sold by the manufacturer of the medical electrical equipment as replacement parts for internal components, may result in increased emissions of decreased immunity of the Oxygen Concentrator. Materials in direct or indirect contact with the patient o o o o o o o o o o o o o o Concentrator casing …………………..….Valtra/ABS/Polystyrene Concentrator Control Panel…………..…..
Do not attempt any maintenance other than the possible solutions listed below. 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. Malfunction. Contact your Equipment Provider, and change to another source of oxygen as necessary. FreeStyle has not detected a breath for 15 minutes. Check the cannula connection.
Problem Probable Cause Solution Rapid alarm condition, and the (yellow) BATT light illuminates intermittently and FreeStyle shuts down. Battery voltage is too low to operate the FreeStyle unit. Connect to DC or an AC outlet immediately. Intermittent alarm condition, and the (red) alarm light illuminates intermittently. Breathing rate has exceeded the capacity of the FreeStyle unit. Reduce activity, and then turn unit off and back on again to reset unit.
FreeStyle Specifications Oxygen Concentration:* 1-3 pulse settings; equivalent to a continuous flow of 90% oxygen +5.5/-3% Flow Rate Settings: 1 ,2 & 3 LPM (equivalent to continuous flow) Settings 1 through 3 ±10% Dimensions: 8.6 in. high x 6.1 in. wide x 3.6 in. deep (21.8 cm high x 15.5 cm wide x 9.1 cm deep) Weight: 4.4 lb (2.0 kg); 1.8 lb (.8 kg) optional AirBelt Power: Universal AC/DC Power Supply (100-240VAC 1.75A Max 50/60Hz) (11-16VDC 8.
“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 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle should assure that it is used in such an environment.
Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle should assure that it is used in such an electromagnetic environment.
Recommended separation distances between portable and mobile RF communications equipment and the FreeStyle The FreeStyle 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.
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