Patient Manual
46 Pages
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Patient Manual
FreeStyle™ 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 (1.52 meters) of the oxygen-carrying accessories. Smoking while wearing an oxygen cannula may cause facial burns and possibly death. Removing the cannula and putting it on bedding, sofas, or other cushion material will cause a flash fire when exposed to a cigarette, heat source, or flame. If you smoke, these 3 steps may save your life: turn off the oxygen concentrator, take off the cannula, and leave the room where this device is located.
“No Smoking – Oxygen in Use” signs must be prominently displayed in the home, or where the oxygen concentrator is in use. Patients and their caregivers must be informed about the dangers of smoking in the presence of, or while using, medical oxygen. English: A multilingual version of the manual is available through your Equipment Provider. Español: Una versión multilingüe del manual está disponible a través de su proveedor de equipo. Français: Une version multilingue du manuel est disponible par l'intermédiaire de votre fournisseur de matériel. Deutsche: Eine mehrsprachige Version des Handbuchs ist in Ihrer Geräte-Anbieter.
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
Power Supplies
19-23
Filters
24
Setting of the Flow Selector
25
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
Limited Warranty
41
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.
Symbols Symbols are frequently used on equipment and/or the manual in preference to words with the intention of decreasing the possibility of misunderstanding caused by language differences. Symbols can also permit easier comprehension of a concept within a restricted space. The following table is a list of symbols and definitions used with the FreeStyle Portable Oxygen Concentrator. Symbol
Description
Symbol
Description
Warning – Describes a hazard or unsafe practice that if not avoided can result in severe bodily injury, death or property damage
Class II Equipment, double insulated
Caution – Describes a hazard or unsafe practice that can result in minor bodily injury or property damage
Note – Provides information important enough to emphasize or repeat
Consult the accompanying documents Use no oil or grease MN123-1 rev E 11/12
Complies with the 93/42/EEC directive drawn up by the approved organization No. 0459 See Instructions
Keep unit and accessories dry
Proper disposal of waste of electrical and electronic equipment required
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RTCA/DO-160 Section 21 Category M Compliant
No Smoking
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. 601.1 M90 for medical electrical equipment
Fragile – handle with care
FAA Approved - POC
Do not expose to open flames
Why Your Physician Prescribed Oxygen Many people suffer from a variety of heart, lung, and other respiratory diseases. A significant number of these patients can benefit from supplemental oxygen therapy at home, when traveling, or while participating in daily activities away from home. Oxygen is a gas that makes up 21% of the room air we breathe. Our bodies depend on a steady supply to function properly. Your physician prescribed a flow or setting to address your particular respiratory condition. Although Oxygen is a non-addictive drug, unauthorized oxygen therapy can be dangerous. You must seek medical advice before you use this oxygen concentrator. The Equipment Provider who supplies your oxygen equipment will demonstrate how to set the prescribed flow rate. The FreeStyle Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician.
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It is very important to select the prescribed level of oxygen flow. Do not increase or decrease the flow until you first consult your physician.
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. The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gases. In the FreeStyle unit, room air passes through a regenerative, adsorbent material called “molecular sieve.” This material separates the oxygen from the nitrogen. The result is a flow of high-concentration oxygen delivered to the patient. FreeStyle combines advanced oxygen concentrator technology along with oxygen conserving technology for the world’s smallest and lightest portable oxygen concentrator at just 4.4 lb (2 kg). The FreeStyle efficiently produces its own oxygen, and quickly delivers it as a pulse of oxygen when you breathe at the very beginning of your inhalation. This eliminates the waste associated with a continuous flow oxygen device that flows oxygen while you are exhaling. This pulsing of the oxygen is equivalent to continuous flow. FreeStyle produces the equivalent of up to 3 LPM (liters per minute) in a lightweight package that can be easily carried and used away from the home. FreeStyle operates from four different power sources. (Refer to the Power Supplies section of this manual.)
Operator Profile: AirSep’s Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which effect the efficiency of ones lungs to transfer the oxygen in air to their bloodstream. POC’s provide the convenience of using a non-delivery POC system rather than delivery system (O2 tank) which makes the user relatively self-sufficient in terms of in-home use, ambulation (both within and outside of the home) mobility and overall lifestyle. Oxygen Concentrator use requires a physician’s prescription, and is not intended for life support use. Although Oxygen therapy can be prescribed for patients of all ages the typical oxygen therapy patient is older than 65 years of age and suffers from Chronic Obstructive Pulmonary Disorder (COPD). Patients typically have good cognitive abilities and MN123-1 rev E 11/12
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must be able to communicate discomfort. If the user is unable to communicate discomfort, or unable to read and understand the concentrator labeling and instructions for use, then use is recommended only under the supervision of one who can. If any discomfort is felt while using the concentrator, patients are advised to contact their healthcare provider. Patients are also advised to have back-up oxygen available (i.e. cylinder oxygen) in the event of a power outage or concentrator failure. There are no other unique skills or user abilities required for concentrator use.
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. In addition, as of May 13, 2009, a new Department of Transporation (DOT)/FAA ruling has determined that US-based carriers, as well as international flights with origination or destination in the US, must allow passengers with FAA-approved portable oxygen concentrators to use them on board, and in flight, as medically necessary. Check directly with the individual airlines with which you would like to travel for up-to-date information on their specific POC policies.
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---- [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. This device supplies high-concentration oxygen that promotes rapid burning. Do not allow smoking or open flames within the same room of (1) this device, or (2) any oxygen-carrying accessory. Failure to observe this warning can result in severe fire, property damage, and/or cause physical injury or death.
If you feel discomfort or are experiencing a medical emergency, seek medical assistance immediately.
Do not heat above 140°F (60°C)
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
Use no oil, grease, or petroleum-based or other flammable products with the oxygen-carrying accessories or the FreeStyle unit. Only water based, oxygen compatible lotions or salves should be used. Oxygen accelerates the combustion of flammable substances.
The incorrect use of the FreeStyle 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 outdoors with the Universal AC/DC power supply, connect the power supply into a Ground Fault Interrupted (GFI) outlet only.
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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 FreeStyle.
No modification of this equipment is allowed.
The FreeStyle 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.
Electrical shock hazard. Disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock hazard. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit.
Care should be taken to prevent FreeStyle from getting wet or allowing water to enter the unit. This can cause the unit to malfunction or shut down.
Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider
In the event of an alarm or you observe that FreeStyle is not working properly; consult the Troubleshooting section in this manual. If you cannot resolve the problem, consult your Equipment Provider.
The FreeStyle Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician.
Operating the FreeStyle 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.)
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Do not allow either the air intake or the air outlet vents to become blocked. This can cause the FreeStyle unit to overheat and affect performance.
Do not operate unit in a restricted or confined space (i.e., a small case or handbag) where ventilation can be limited. This can cause the FreeStyle unit to overheat and affect performance.
When using FreeStyle in an automobile, boat, or on other DC sources with the Universal AC/DC power supply, make sure that the vehicle is started and running before connecting the FreeStyle unit. If the Universal AC/DC power supply does not illuminate and requires resetting, disconnect the power supply from the DC outlet, restart your vehicle, and then reconnect your power supply into the DC outlet. Failure to follow these instructions can result in the power supply not supplying power to FreeStyle. When the automobile in which you are using the FreeStyle unit is turned off, disconnect and remove the unit from the automobile with you. Do not store FreeStyle in a very hot automobile or in other similar, high-or low-temperature environments. Operating or storing the unit outside the normal temperature range can affect the performance of the FreeStyle. (Refer to the Specifications section in this manual.)
If the FreeStyle has been stored for an extended period of time outside its normal operating temperature range, the unit should be allowed to return to normal operating temperature before being turned on. (Refer to the Specifications section in this manual.)
It is very important to select only the prescribed level of oxygen. Change the pulse flow selection only under the guidance of your physician.
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.
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The concentrator should be located as to avoid pollutants or fumes.
Do not position the Concentrator so that it is difficult to access the power cord.
Portable and mobile RF communications equipment can effect medical electrical equipment.
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. This ensures that the FreeStyle unit can properly detect inspiration for oxygen delivery.
Storing your FreeStyle for extended periods of time at high temperatures or with a fully charged or completely discharged battery can degrade its overall battery life.
Depending upon the temperature of the FreeStyle battery, it can take several minutes for the charging cycle to start after connecting to power. This is a normal condition and is intended for safe charging.
The FreeStyle battery does not need to be fully discharged before recharging. It is recommended to charge the FreeStyle battery after each use.
Charging 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.
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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 unit shuts down, the unit cannot be restarted with the AirBelt. Should this occur, connect your FreeStyle to its Universal AC/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.
If the FreeStyle power supply remains connected when the battery is fully charged, the four LEDs will turn off within approximately 1 hour.
It may be necessary to initially connect the Universal AC/DC FreeStyle power supply to the FreeStyle unit before the unit will operate for the first time on battery power. Your Equipment Provider may have already performed this step for you.
Use only AirSep Part No. FI144-1 for air intake filter for this unit.
Do not operate FreeStyle without the air intake filter in place. If a second filter is provided, insert the “replacement” filter before you clean the dirty filter.
AirSep does not recommend the sterilization of this equipment.
Do not attempt any maintenance other than the possible solutions listed within this manual. The lithium ion rechargeable battery that is used in the FreeStyle unit does not need to be fully depleted before recharging. It is recommended to charge the battery regardless of the battery’s capacity level after use. The battery will charge when the unit is off as well as while the unit is running off the Universal AC/DC power supply.
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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.
“No Smoking – Oxygen in Use” signs must be prominently displayed in the home, or where the oxygen concentrator is in use. Patients and their caregivers must be informed about the dangers of smoking in the presence of, or while using, medical oxygen.
Important Safety Rules for Optional AirBelt 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.
Replace safety cap on AirBelt cord when not in use.
Do not attempt to charge the optional AirBelt with the FreeStyle Universal AC/DC power supply, or AirBelt can be damaged. Use only the AirBelt power supply provided to charge AirBelt.
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 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.
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[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. DC Power Cable
Figure 2: FreeStyle Universal AC/DC Power Supply/Power Cord
Figure 1: FreeStyle Unit
Figure 3: FreeStyle DC Power
Optionally, you may also have an AirBelt for extended battery duration. That packaging contains the following, as shown in Figure 4:
AirBelt battery belt Universal AC/DC power supply (100-240 Volt, 50/60 Hz) with power cord
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The incorrect use of the AirBelt 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.
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 carrying bag to a backpack (part number MI284-1), as shown in Figure 5. The FreeStyle can also be worn on the waist if desired by feeding the AirBelt or other belt you are wearing through the loops on the FreeStyle carrying case. (See Figure 6.) The optional accessories bag (part number MI320-1) enables even more convenient travel when transporting all power accessories and optional AirBelts and/or the harness for use at your intended destination.
Figure 4: AirBelt and Universal AC/DC Power Supply/Power Cord
Figure 5: FreeStyle unit worn backpack style
Figure 6: FreeStyle unit worn on the waist
Replace safety cap on AirBelt cord when not in use.
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Before operating FreeStyle for the first time, familiarize yourself with the major components. These are illustrated in the figures on the following pages and discussed later in the manual.
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. To charge FreeStyle’s internal battery, simply connect its Universal AC/DC power supply into the unit’s power connection inlet (as shown in Figure 7). Be certain to first properly align the power cord to this inlet. To do this, take note of the “D”-shaped plug of both the power cord connector and the FreeStyle’s inlet connection. These must be properly aligned and when removing the power cord, the release button must be pressed to remove it from the FreeStyle unit. This ensures that neither the unit nor the power accessories are damaged. FreeStyle unit’s Power Inlet
Press to remove power cord.
Optional AirBelt The optional AirBelt, which can increase FreeStyle’s total battery duration up to 10 hours, requires approximately 3 hours to completely charge when the external battery is fully depleted. To recharge AirBelt, connect its own AC power supply to the end of AirBelt’s power cord (as shown in Figure 8), and the other end of the power supply into a proper AC power outlet. A separate battery gauge/indicator for checking the level of charge on the AirBelt’s battery is located on this accessory’s cord and functions exactly like the internal battery’s indicator on the keypad.
Depending upon the temperature of the FreeStyle battery, it can take several minutes for the charging cycle to start after connecting to power. This is a normal condition and is intended for safe charging.
The FreeStyle battery does not need to be fully discharged before recharging. It is recommended to charge the FreeStyle battery after each use.
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Charging 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.
Figure 7: Internal Battery Charging
Figure 8: AirBelt Battery Charging
AirBelt does not need to be fully discharged before recharging. It is recommended to charge it after each use.
The FreeStyle’s internal battery will completely recharge from its fully depleted state in approximately 3 ½ hours, whether or not the unit is in use on Universal AC/DC power. While charging a fully discharged battery, initially the 25% LED will start blinking rapidly for a few minutes, then start to blink at a slower rate every (1/2 second). The LED will continue to blink until 25% capacity is reached. The LED will then turn solid. Each of the four LEDs, 25% -100%, will blink as stated above, then turn solid when they reach their capacity. When all LEDs illuminate solid, the battery is fully charged and the LEDs will remain solid for a period of time, then all four LEDs will turn off. 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.
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---- [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. Replace the disposable cannula periodically following normal usage. Additional supplies are available from your Equipment Provider.
Cannula tubing must be non-kinking, which 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 the cannula should be replaced.
Make sure the cannula is fully inserted and secure. This ensures that the FreeStyle unit can properly detect inspiration for oxygen delivery.
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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.
Label/Patient Instructions
Figure 12: FreeStyle Exterior View - Back
Now that you are familiar with FreeStyle’s components, review the instructions on the following pages to operate the FreeStyle unit. MN123-1 rev E 11/12
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