Patient Manual Focus™ 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® Focus™ Portable Oxygen Concentrator AirSep’s Focus™ Portable Oxygen Concentrator 1 Symbols 1-2 Why Your Physician Prescribed Oxygen 2-3 What is the Focus Portable Oxygen Concentrator? 3 Operator Profile 3 Focus for Airline Travel - FAA Approved 4 Important Safety Rules 5-10 Getting Started with Your Focus Portable Oxygen Concentrator 11-14 Battery Charging 15 Optional AirBelt / Charging the Optional AirBelt 16-18 Nasal Cannula 19-20 Focus Unit Components 20
TABLE OF CONTENTS AirSep® Focus™ Portable Oxygen Concentrator Audible Alarm and Indicator Lights 23 How to Respond to Focus’s Audible Alarm and Indicator Lights 23-25 Cleaning, Care, and Proper Maintenance 26 Cabinet 26 Carrying Bag 26 Focus Accessories 27 Materials in direct or indirect contact with the patient 28 Reserve Oxygen Supply 28 Troubleshooting 28-29 Focus Specifications 30-33 Classification 34
AirSep’s Focus™ Portable Oxygen Concentrator This Patient Manual will acquaint you with AirSep’s Focus™ Portable Oxygen Concentrator (POC). Make sure you read and understand all the information contained in this manual before you operate your Focus unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
RTCA/DO-160 Section 21 Category M Compliant Fragile – handle with care Keep unit and accessories dry Use no oil or grease Proper disposal of waste of electrical and electronic equipment required No smoking Do not disassemble Type BF equipment Consult instructions for use FAA Approved - POC Do not expose to open flames RTCA DO160 Section 21 Category M Compliant.
What is the Focus Portable Oxygen Concentrator? Oxygen concentrators were introduced in the mid-1970s 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.
Focus for Airline Travel – FAA-Approved Focus 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.
[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 Focus 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 oilbased 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 low-temperature 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 Focus 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 Focus Portable Oxygen Concentrator The Focus packaging contains the following items, as shown below. If any items are missing, contact your Equipment Provider. 1) 2) 3) 4) 5) 6) 7) 8) Focus unit with carrying bag.
Connecting to the Focus Power Inlet: Locate the arrow marking at the top of the connector. Insert connector (Figure 5) into the Focus power inlet (Figure 6) with the arrow on the side of the connector facing outward. Do not force the connector into the power inlet, as it can be inserted only one way. This ensures that neither the unit nor the power accessories are damaged.
2) Connecting Focus to a DC power source: The universal power supply can also be used to operate the Focus unit from any 12-Volt DC power source. For example: to an automobile, (boat, motor home, etc.) with a 12-Volt DC outlet. Connect the power supply cord labeled DC OUT To Focus into the Focus unit’s power inlet, as shown in Figure 8. Place the DC accessory adapter on the end of the DC power cord. Connect the other end into the power supply input connection labeled Accessory DC IN.
3) Connecting Focus with the Battery, as shown: Before using the battery, check that it has a sufficient charge. The battery is equipped with a gauge (Figure 9) to indicate the level of battery charge (25-100%). To check the level of charge of the battery, press the button on the battery’s keypad. The battery gauge/indicator(s) LEDs to the left of the button illuminate to indicate the level of battery charge (25-100%).
Battery Charging Check to make sure your unit’s battery is fully charged before venturing out with Focus for the first time or upon subsequent use. To check the level of charge of the battery, press the button on the battery’s keypad. The battery gauge/indicator(s) illuminate to indicate the level of battery charge (25-100%). To charge the Focus battery while using Focus: 1a) Using AC Power: Follow the instructions in the Connecting Focus to AC electrical power section.
Optional AirBelt Optionally, you may also have an AirBelt for extended use of Focus. The optional AirBelt (Figure 14), can power the Focus unit for up to 4 hours. Before using AirBelt, check that it is sufficiently charged. It requires approximately 3 hours to completely charge. AirBelt is equipped with a battery gauge/indicator to indicate the level of battery charge (25-100%). To check the level of charge, press the button on the AirBelt keypad.
Charging the Optional AirBelt To charge the AirBelt battery for extended use: 1) Release safety cap from end of the AirBelt cord. 2) Connect the Universal AC/DC power supply (included with AirBelt Accessory kit) to the end of AirBelt’s power cord, as shown in Figure 17. 3) Connect the AirBelt power supply to an AC electrical outlet to recharge.
The optional AirBelt will completely recharge from its fully depleted state in approximately 3 hours. While charging a fully discharged battery, 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 the battery reaches it’s 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.
[Read the Important Safety Rules section before operating this equipment] Nasal Cannula A nasal cannula with tubing are used to deliver oxygen from the Focus unit to the user. The tubing is connected to the unit’s oxygen outlet (See Figure 18). Focus Power Inlet Connect the Cannula to Focus’s Oxygen Outlet Figure: 18 AirSep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No. CU002-1, or other suitable cannula.
Focus Unit Components Focus Control Panel (Top view): Alarm Display and Power Inlet F i g u r e Focus Power Inlet Air Outlet 4 Alarm Indicator Figure: 19 Bi-color LED Green light: On/ Pulse Flow Indicator Amber light: Alarm and Service Indicator Air Inlet Figure 20: Focus Exterior View - Front F i g u r e Label/Patient Instructions 4 Figure 21: Focus Exterior View - Back Now that you are familiar with Focus’s components, review the instructions on the following pages to operate the Focus unit.
[Read the Important Safety Rules section before operating this equipment] Operating Instructions 1. Locate and position Focus so that the air inlet and outlet are not obstructed. 2. Power the unit from (a) the battery; (b) DC outlet (i.e. automobile or motor boat); or (c) an AC outlet (i.e. normal household electric). (Refer to the Power Supplies section of this Patient Manual. (Refer to Connecting to Focus’s Power Inlet section for specific instructions on the connection of power sources.) 3.
[Read the Important Safety Rules section before operating this equipment] Power Supplies (Overview) Focus can be powered in four different ways – the battery, AC power, DC power, or an optional AirBelt. The Focus power supply functions both as an AC power supply and a DC power supply. (Refer to Connecting to Focus’s Power Inlet section for specific instructions regarding the connection of optional power sources.) Battery: Two rechargeable batteries are supplied with Focus.
[Read the Important Safety Rules section before operating this equipment] Audible Alarm and Indicator Lights When the Focus unit senses inhalation, a pulse of oxygen is delivered through the nasal cannula. The green light on the unit’s control panel blinks each time a breath is detected.
This unit is not to be used for life support. Geriatric, pediatric, or any other patient unable to communicate discomfort while using this device may require additional monitoring. Patients with hearing and/or sight impairment(s) may need assistance with monitoring alarms. Pulse Dose Node settings must be determined for each patient individually for their needs at rest, during exercise, and when traveling. If you feel discomfort or are experiencing a medical emergency, seek medical assistance immediately.
How to Respond to Focus’s Audible Alarm and Indicator Lights Status Audible Alarm Light Indicates Action Indicator Brief, continuous at start–up (Green) and (Red) alternate; then (Green) continuous light Focus has been turned on. You may begin to operate your Focus unit. Indicator No (Green) flashes; on each breath Focus is delivering oxygen as a pulse flow. Continue using Focus normally. Indicator No (Amber) continuous light Inspection and/or 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.
Carrying Bag, Battery Case, Belt and Strap To clean the carrying bag, battery case, belt, and strap, brush only with warm, soapy water (do not saturate), then allow to air dry. Do not machine wash or dry. Focus Accessories For proper performance and safety, use only these listed accessories supplied by AirSep through your Equipment Provider. Use of accessories not listed below could adversely affect the performance and/or safety of the Focus Portable Oxygen Concentrator.
Materials in direct or indirect contact with the patient o Concentrator casing …………………Valtra/ABS/Polystyrene o Concentrator Control Panel………….Nitrile Rubber o Gas Outlet …………………………….Delrin o ON/OFF Power Switch……………….Thermoplastic o Unit Label ……………………………..Lexan o Coil cords ……………………………..Polyurethane o Cord connectors ……………………...Polycarbonate/Vinyl chloride o Cord switch…………………………….Nylon o Power Supply…………………………..
Problem Probable Cause Solution Alarm condition, Intermittent: Beep, beep (Amber) light illuminates simultaneously and Focus shuts down. Battery voltage is too low to operate the Focus unit. Connect to DC or an AC outlet immediately. Alarm condition, Intermittent: Beep, beep, beep and the (Amber) alarm light illuminates simultaneously. Breathing rate has exceeded the capacity of the Focus unit. Reduce activity, and then turn unit off and back on again to reset unit.
Focus Specifications Oxygen Concentration:* Pulse Dose: Dimensions: Pulse setting equivalent to a continuous flow of 90% oxygen - 3% / +5.5% 17.25ml ± 10% Weight: Concentrator 1.75 lb (0.8 kg) Battery 0.53 lb (0.2 kg) Optional AirBelt Battery 1.8 lb (0.8 kg) Power: Battery duration (Rechargeable lithium Battery) Battery recharge time: Warm-up time: Battery cycle life: Audible alarms and pulse visual indicators: **Temperature range: **Operational Altitude: 6.4 in. high x 4.8 in. wide x 2.5 in.
“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 Focus is intended for use in the electromagnetic environment specified below. The customer or the user of the Focus should assure that it is used in such an environment.
Guidance and manufacturer’s declaration ± electromagnetic immunity The Focus is intended for use in the electromagnetic environment specified below. The customer or the user of the Focus should assure that it is used in such an electromagnetic environment.
Recommended separation distances between portable and mobile RF communications equipment and the Focus The Focus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Focus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Focus as recommended below, according to the maximum output power of the communications equipment.
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. Independent testing for Medical Electrical Equipment Standard: Tested by QPS Testing Services NA Inc.
For European Representative: Medical Product Services GmbH (MPS) Borngasse 20 35619 Braunfels, Germany Tel: +49 (0) 6442-962073 E-mail: info@mps-gmbh.
For service on your Focus Portable Oxygen Concentrator, please contact your local Equipment Provider at: Manufactured by: AirSep Corporation |MN170-1_DO~ MN170-1 Rev D MN170-1 rev D 36
