CAIRE FreeStyle Comfort Technical Manual
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FreeStyle
Comfort
Technical Manual
(English) MN233 B

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Summary of Contents for CAIRE FreeStyle Comfort

  • Page 1 ™ ® FreeStyle Comfort Technical Manual (English) MN233 B...
  • Page 2: User Controls & System Status Indicators

    FreeStyle Comfort User Controls & System Status Indicator ISO 7000: graphical symbols for use on Council Directive 93/42/EEC; concerning equipment – Index and synopsis medical devices Read user’s manual before Authorized representative in operation Reg. #1641 the European Community This device complies with...
  • Page 3 FreeStyle Comfort Council Directive 2012/189/EU: waste electrical and electronic equipment (WEEE) WEEE Contains FCC ID: WAP 2001 FCC Notice FCC NOTICE: This device may contain CYBLE-022001-00, including the antenna 2450AT18B100 from Johnson Technology, complies with par 15 of the FCC rules. The device meets the requirements for modular transmitter approval as detailed in FCC public Notice DA00-1407.
  • Page 4: Table Of Contents

    FreeStyle Comfort Table of Contents User Controls & System Status Indicators ...................... 2 FreeStyle Comfort Overview .......................... 5 Description of Operation ..........................7 Safety Instructions ............................8 Specifications ..............................13 Test Procedures ............................. 14 Patient Cleaning, Care & Routine Maintenance ................... 19 Equipment Provider Maintenance .........................
  • Page 5: Freestyle Comfort Overview

    FreeStyle Comfort FreeStyle Comfort Overview Front View User Interface Strap Attachment Air Outlet Oxygen Outlet Power Port Air Intake/Filter Receptacle Tab Battery Pack Battery Pack Release Button Increase Setting Display Screen Decrease Setting Power Button...
  • Page 6 FreeStyle Comfort Display Screen on Battery Display Screen On AC/DC Power...
  • Page 7: Description Of Operation

    The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gasses. In the FreeStyle Comfort, room air is drawn into the machine through the air intakes. 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.
  • Page 8: Safety Instructions

    THE PATIENT MIGHT NOT TRIGGER THE LOCATED AS TO AVOID SMOKE, POLLUTANTS CONVERSERING FUNCTION WARNING: THE OR FUMES. FREESTYLE COMFORT IS NOT INTENDED FOR USE WITH A TRACHEOTOMISED PATIENT WARNING: PREGNANT OR NURSING WOMEN SHOULD NOT USE ACCESSORIES RECOMMENDED IN THIS MANUAL, THEY MAY...
  • Page 9 FreeStyle Comfort WARNING: THE USE OF SOME OXY- WARNING: DO NOT ALLOW EITHER THE AIR GEN ADMINISTRATING ACCESSORIES INTAKE OR THE AIR OUTLET EXHAUST TO NOT SPECIFIED FOR THIS OXYGEN BECOME BLOCKED. DO NOT DROP OR INSERT PERFORMANCE. RECOMMENDED AC-...
  • Page 10 FreeStyle Comfort WARNING: DO NOT USE EXTENSION CORDS WARNING: IF YOU SMOKE, THESE 3 STEPS MAY WITH THIS UNIT OR CONNECT TOO MANY PLUGS SAVE YOUR LIFE: TURN OFF THE OXYGEN INTO THE SAME ELECTRICAL OUTLET. THE USE CONCENTRATOR, TAKE OFF THE CANNULA,...
  • Page 11 FreeStyle Comfort CAUTION: Operating or storing the Oxygen WARNING: SMALL PARTS MAY Concentrator Outside of its normal operating HAZARD. temperature range and ambient pressure range WARNING: AVOID CONTACT, LONGER THAN 10 (altitude) can affect performance and decrease SECONDS, WITH EXHAUSR VENT AS IT MAY BE battery run time and/or increase battery charge WARM.
  • Page 12 FreeStyle Comfort ONLY REMOVE THE BATTERY PACK WHEN THE UNIT IS POWERED OFF AND UNPLUGGED FROM THE POWER SUPPLY. DO NOT ATTEMPT TO REMOVE THE BATTERY PACK WHILE THE UNIT IS STILL ON OR PLUGGED INTO THE POWER SUPPLY. Note: If the oxygen concentrator has been stored...
  • Page 13: Specifications

    FreeStyle Comfort Specifications FreeStyle Comfort Dimensions (with Single Battery) 10.0 x 7.3 x 3.1 in (25.4 x 18.5 x 7.9 cm) Dimensions (with Double Battery) 11.0 x 7.3 x 3.1 in (27.9 x 18.5 x 7.9 cm) Weight (with Single Battery Pack) 5 lbs.
  • Page 14: Test Procedures

    Align the battery with the bottom housing from the center of the FreeStyle Comfort. Turn on the FreeStyle Comfort by pressing the power button and select your prescribed flow setting utilizing the increase (+) or decrease (-) flow buttons.
  • Page 15 FreeStyle Comfort Pulse Volume (mL)* Setting Breath Rate Note: When the Freestyle Comfort is initially 10.5 31.5 52.5 turned on the default flow setting is 2. If the 16.8 25.2 33.6 setting is changed, the unit will power on to the previous flow setting.
  • Page 16 VERIFY AC AND DC OPERATION maintenance: The FreeStyle Comfort comes with an AC and To view the total operating hours, turn DC power supply to keep your concentrator the unit on and enter Test Mode per the powered wherever you go.
  • Page 17 TERNAL POWER WITHOUT A connector inlet on the front, right bottom BATTERY PACK INSTALLED IN THE of the FreeStyle Comfort. Be sure to push OXYGEN CONCENTRATOR. inward so that the connection is secure. 5. Turn on the FreeStyle Comfort by pressing...
  • Page 18 FreeStyle Comfort 2. Connect the DC power supply to the power port receptacle front, bottom right side of the FreeStyle Comfort. Be sure to push inward so that the connection is secure. 2. Enable airplane mode by press and hold...
  • Page 19: Patient Cleaning, Care & Routine Maintenance

    Do not place the battery in or near a microwave or other cooking appliances. AIR INTAKE FILTERS Air enters the FreeStyle Comfort through air intake BATTERY PACK DURATION filters located on the front, bottom of the oxygen concentrator. These filters prevent dust and other...
  • Page 20 FreeStyle Comfort WARNING: TURN OFF THE UNIT AND BATTERY PACK STORAGE DISCONNECT THE POWER CORD The oxygen concentrator battery does not need to FROM THE ELECTRICAL OUTLET be fully discharged before recharging. It is BEFORE YOU CLEAN THE UNIT TO...
  • Page 21: Equipment Provider Maintenance

    Additional supplies for replacement are available 3. Once the oxygen outlet is removed, the through your oxygen provider. product filter can be taken out by simply tipping the FreeStyle Comfort to its side, and the filter will disengage from its Equipment Provider position.
  • Page 22 BASED PRODUCTS (PINE-SOL, NEW PATIENT USE LESTOIL). THESE ARE NOT TO BE USED TO CLEAN THE PLASTIC When you remove the FreeStyle Comfort from a HOUSING ON THE FREESTYLE patient’s home, always detach and dispose of the COMFORT, THEY CAN DAMAGE used nasal cannula.
  • Page 23 FreeStyle Comfort RECORDING MAINTENANCE Whenever maintenance or service is performed on a unit, an entry should be made in the service log for that concentrator or recorded in accordance with your company’s standard procedure. FreeStyle Comfort Serial Number DATE HOUR INITIALS...
  • Page 24: Service Procedures

    PERFORMING ANY MAINTENANCE TO PREVENT manifold. ACCIDENTAL ELECTRICAL SHOCK AND BURN HAZARD. THE FREESTYLE COMFORT MUST BE OFF AND DISCONNECTED FROM XTERNAL POWER BEOFRE REMOVING THE BATTERY PACK Disconnect the unit from the AC or DC outlet.
  • Page 25: Alarm Conditions

    FreeStyle Comfort Alarm Conditions Priority Alarm Display Screenshot Display Audible More Details Description Category Signal System Alarm 1 beep Unit will alarm when Malfunction every 20 battery temperature is Battery over sec. approaching safety Temp shutdown threshold. If shutdown threshold is reached, unit will shut down.
  • Page 26 FreeStyle Comfort Low Battery Alarm 1 beep Alarms until battery Shut Down every 30 runs out of power and sec. unit shuts down. Warm up Info(pre None Unit will start by auto- cedence dosing until a breath is over low...
  • Page 27 FreeStyle Comfort System Alarm None Malfunction Pressure System Alarm None Malfunction Low Temp Airplane Info None Airplane Mode on Mode battery power. Airplane Info None Airplane Mode on Mode external power. *All visual alarms are shown with a yellow border on the display screen...
  • Page 28: Troubleshooting

    *Unit will shut off if it Greater Than reaches an internal 60 °C temperature of 65 °C * Vent Blockage Ensure there are no Other blockages on any vents of the unit. Contact Caire to send the unit in for repair.
  • Page 29 FreeStyle Comfort 0x0004 High Sieve Bed Replace sieve beds. Pressure Failure Replace feed/waste valves. Feed/Waste Valve Failure Contact Caire to send the Other unit in for repair. 0x0008 No Breath Outlet Filter Check the cannula is leak- Detected Other free Replace outlet filter.
  • Page 30 15 minutes without than 40 BPM breathing off the unit. Other Ensure alarm does not occur during this period. Contact Caire to send the unit in for repair. 0x0400 Fan Failure Other Contact Caire to send the unit in for repair.
  • Page 31: Accessories And Spare Parts List

    FreeStyle Comfort Accessories and Parts List For proper performance and safety, use only these listed accessories supplied by CAIRE through your oxygen provider. Use of accessories not listed below could adversely affect the performance and/ or safety of the concentrator.
  • Page 32: Notes

    FreeStyle Comfort Notes...
  • Page 33 Tel: +49 (0) 6442-962073 E-mail: info@mps-gmbh.eu Worldwide: www.CAIREmedical.com Copyright © 2018 Chart Industries. CAIRE Inc. reserves the right to discontinue its products, or change the prices, materials, equipment, quality, descriptions, specifications and/or processes to its products at any time without prior notice and with no further obligation or consequence.

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