CAIRE FreeStyle, Manual

Page 1: ......

Page 2: ...lassifications 11 Provider Support Policy 12 Definition of Symbols 13 How the FreeStyle and FreeStyle 5 Work 14 Flow Rates 15 Indications for Use 16 Contraindications 17 Introduction 18 Pre Delivery C...

Page 3: ...tenance 47 Service 52 Housing Removal 53 PSA Removal 55 Compressor Replacement 61 Product Manifold Replacement 63 Solenoid Valve Replacement 65 Sieve Bed Replacement 66 Feed Waste Manifold Replacement...

Page 4: ...eration Providers are given proper guidance in the use of the FreeStyle and FreeStyle 5 and their accessories that can be conveyed to patients Providers are made aware of the care diagnostics maintena...

Page 5: ...MN220 1 B 5 Portable Oxygen Concentrator INTRODUCTION TO THE FREESTYLE...

Page 6: ...nal Components Handle Oxygen Outlet Air Outlets External Power Input Air Intake Filter Cover Alarm Service Indicator Selector Buttons Rechargeable Battery Button Battery Charge Indicators Pulse Flow I...

Page 7: ...MN220 1 B 7 Portable Oxygen Concentrator INTRODUCTION TO THE FREESTYLE 5...

Page 8: ...ernal Components Figure 2 2 Control Panel Handle Oxygen Outlet Air Outlets External Power Input Air Intake Filter Cover External Battery Pack Pulse Flow Indicators Alarm Service Indicator Selector But...

Page 9: ...ting 1 4 25 hours Setting 2 2 5 hours Setting 3 1 75 hours Setting 4 1 5 hours Setting 5 1 25 hrs Warm Up Time 2 minutes 2 minutes Operating Temperature 41 F to 104 F 5 C to 40 C 41 F to 104 F 5 C to...

Page 10: ...e breathing through your nose If the alarm persists contact your Equipment provider Alarm Intermittent Beep beep beep 25 Yellow BATT battery indicator Battery voltage is too low to operate the FreeSty...

Page 11: ...Standard CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety Protection against potential electromagnetic or other interference between the equipment and ot...

Page 12: ...Monday Friday 8 30am 5 00pm EST CAIRE can only support customers who are recognized as Providers Dealers Distributors and or Agents These partnerships are qualified as having an existing account or ar...

Page 13: ...y agency for CAN CSA C22 2 No 601 1 M90 for medical electrical equipment FAA Approved POC Serial Number Date of Manufacture Class II Equipment Prescription only Consult instructions for use No Smoking...

Page 14: ...exchanger to reduce the temperature Next a solenoid feed valve directs the air into one of two sieve beds that contain molecular sieve The unique property of molecular sieve enables it to physically...

Page 15: ...maintain a constant volume per minute Flow Setting FreeStyle Volume mL min FreeStyle 5 Volume mL min Setting 1 227 5 mL min 227 5 mL min Setting 2 420 mL min 420 mL min Setting 3 500 mL min 630 mL mi...

Page 16: ...of a physician or other licensed health care provider It is very important to select only the prescribed level of oxygen Do not change the flow selection unless you have been directed to do so by a li...

Page 17: ...zardous These devices should only be used when prescribed by a physician Not for use in the presence of flammable anesthetics As with any electrically powered device the user may experience periods of...

Page 18: ...ple Easy to use controls FreeStyle battery pack Quiet operation Alarm system After completing each training procedure ask your patient if he or she has any questions Proper training of your patients w...

Page 19: ...d from external power before removing the battery pack 1 Install the battery pack 2 Connect the AC Power Supply to the POC and connect the AC power cord from the Power Supply to a 100 240 volt 50 60 H...

Page 20: ...eathing through your nose If the alarm continues to sound change to another source of oxygen as available and contact your Equipment Provider BREATH RATE EXCEEDED If your breathing rate causes the cap...

Page 21: ...sh and implement their own protocol to check oxygen concentration 1 Connect the POC using the supplied AC power supply to a 100 240 volt 50 60 Hz electrical outlet 2 Turn unit on by pressing setting 2...

Page 22: ...warranty Keep the POC at least five 5 ft feet 1 5 m from heat sources sparking objects or open flames Ask your patient where they would like to set up the device While unpacking and setting up the dev...

Page 23: ...nt the icons and symbols and explaim what each one means Explain each step in the operation of the unit to the patient with reference to the patients User Manual Advise your patient to thoroughly read...

Page 24: ...right side of the FreeStyle or FreeStyle 5 so that it will slide into the empty compartment Push the battery inward until you hear a click to confirm that it has locked in place Figure 5 2 Battery Pa...

Page 25: ...he depressed finger slot to grip the battery when pulling outward Figure 5 3 Battery Pack Removal CHECKING BATTERY PACK CHARGE To check the battery charge when it is installed in the FreeStyle or Free...

Page 26: ...charge when it is not installed in the FreeStyle or FreeStyle 5 turn the battery on its back and press the TEST button The battery gauge indicator lights 25 100 will illuminate to the left of the TES...

Page 27: ...ed The LED will then turn solid Each of the 4 battery gauge indicator lights 25 100 will blink as stated above during charging then turn solid when they reach capacity When all 4 of the battery gauge...

Page 28: ...battery is between 4 5 hours If using the optional desktop charger the battery pack will fully charge in 4 5 hours FREESTYLE AC DC POWER SUPPLY The FreeStyle is equipped with a universal AC DC power...

Page 29: ...is fully functional on AC power for use The unit will also recharge the battery pack if needed any time AC power is available The battery pack will recharge both if the unit is off or on and in use T...

Page 30: ...Connecting Power Supply to FreeStyle Connect the AC power cord to the unmarked AC inlet on the power supply Figure 6 2 Connecting AC Cable to Power Supply Connect the opposite end of the AC power cor...

Page 31: ...luminated check for secure connections and refer to the troubleshooting section of this manual Figure 6 4 Green Light on Universal Power Supply If the battery pack is in need of re charge the battery...

Page 32: ...ed any time DC power is available The battery pack will recharge both if the unit is off or on and in use Connect the universal power supply to the power connector inlet on the side of the FreeStyle B...

Page 33: ...motor vehicle Ensure the green light on top of the Universal power supply is illuminated This indicates that the power supply is receiving power from the outlet If the green light is not illuminated d...

Page 34: ...yle 5 is equipped with separate power supplies for AC and DC operation The FreeStyle 5 includes the following 1 AC power supply which operates on AC Power between 100 240 volts 50 60Hz 2 Removable AC...

Page 35: ...in use To connect the FreeStyle 5 to AC Power Connect the AC power supply to the power connector inlet on the side of the FreeStyle 5 Be sure to push inward so that the connection is secure Figure 7 1...

Page 36: ...nnecting Power Supply to AC Outlet Ensure the green light on top of the AC power supply is illuminated This indicates that the power supply is receiving power from the outlet If the green light is not...

Page 37: ...is for use in the accessory outlets of automobiles boat or other motor vehicles The FreeStyle 5 is fully functional on DC power for use The FreeStyle 5 will also recharge the battery pack if needed an...

Page 38: ...connect the power supply from the DC outlet restart the motor vehicle and then reconnect the power supply to the DC outlet Figure 7 7 Green Light on AC Power Supply If the battery pack is in need of r...

Page 39: ...physician is to perform the necessary tests to prescribe treatment ACTIVE LIFESTYLE TRAINING Small lightweight and easily moved about the FreeStyle and FreeStyle 5 units are ideally suited to an activ...

Page 40: ...n To train your patient on mobility and ambulation follow the procedures below TRAVELING BY VEHICLE Ask your patient whether he or she will be using the device to travel by vehicle If so show your pat...

Page 41: ...xit or the aisle s in the passenger compartment of the aircraft if the unit is used Users are not permitted to be seated in an exit row if using the FreeStyle or FreeStyle 5 If the FreeStyle or FreeSt...

Page 42: ...e output and efficient operation of the unit the patient must perform simple routine maintenance tasks Clean the air intake gross particle filter cabinet and power supplies weekly CLEANING THE AIR INT...

Page 43: ...e excess water with a soft absorbent towel Ensure that the filter is dry before replacing it 5 Replace the dry filter into the filter cover 6 Place the filter cover back into the housing and gently pu...

Page 44: ...or sponge 5 Spray or wet the cloth or sponge with the mild detergent solution DO NOT spray the cabinet control panel or power supplies 6 Wipe down the cabinet control panel and power supplies CANNULA...

Page 45: ...Contraindications Basic Concept Training Advise to read the User s Manual Go over all Accessories included with the Unit Safety Guidelines and Operational Safety Warnings Cautions Locating the Unit Pa...

Page 46: ...or Use Around the House Traveling by Vehicle Traveling by Air Traveling by Boat Traveling by Train FreeStyle Maintenance Weekly Clean the Air Inlet Gross Particle Filter Weekly Clean the Cabinet Contr...

Page 47: ...You can easily remove it by hand Instruct the patient to clean this filter weekly Reference CLEANING THE AIR INTAKE GROSS PARTICLE FILTER section of this manual The filter may require more frequent cl...

Page 48: ...oduct filter volume tank to the product manifold 7 Connect the tubing and secure with a tie wrap Figure 9 Product Filter If the compressor inlet felt filter shown above is contaminated a replacement f...

Page 49: ...you remove the FreeStyle or FreeStyle 5 from a patient s home always detach and dispose of the used nasal cannula Clean the exterior of the unit with a mild household cleaner applied with a damp clot...

Page 50: ...week depending on the environment during normal operation Allow the unit to air dry Then re test oxygen concentration test the duration of the battery pack and ensure the AC and DC power supplies are...

Page 51: ...MN220 1 B 51 Portable Oxygen Concentrator Figure 10 Maintenance Log PURITY ALARM COMMENTS SYSTEMCHECKOUT FreeStyleSerialNumber _________________ DATE HOURMETERREADING INITIALS SERVICEPERFORMED...

Page 52: ...tools are generally readily available for purchase in your local area and can assist you in servicing and maintaining the FreeStyle or FreeStyle 5 unit Figure 11 5 Pressure Test Gauge Figure 11 1 25in...

Page 53: ...prevent accidental electrical shock and burn hazard The FreeStyle or FreeStyle 5 must be off and disconnected from external power before removing the battery pack Note all scheduled maintenance See EQ...

Page 54: ...ift off the front cover Figure 12 1 Removing Front Cover Removing Back Cover 1 Place the unit on its front 2 Locate the four screws securing the back cover 3 Using a Philips head screwdriver loosen an...

Page 55: ...m the electrical outlet before servicing to prevent accidental electrical shock and burn hazard 1 Disconnect the unit from the AC or DC outlet 2 Remove the battery 3 Remove the front housing 4 Disconn...

Page 56: ...e 13 2 Foam Removal Steps 6 and 7 require extreme caution to ensure the black pressure sensor U3 for FreeStyle or U9 for FreeStyle 5 is not damaged 6 Remove the adjustable nozzle by gently pulling it...

Page 57: ...e 13 3 Nozzle Removal 7 Carefully disconnect the 1 8 OD tubing coming from the back of the unit to the limiting orifice Figure 13 4 Disconnecting Black Tubing 8 Remove the 8 32 x 1 4 Philips screws lo...

Page 58: ...tlet Nozzle Cradle Screw Removal 9 Turn the unit over and remove the back housing 10 Disconnect the ground wire connected to the compressor on its upper right side near the air inlet filter using a Ph...

Page 59: ...de located at the back of the PSA System 12 For the FreeStyle remove each tie wrap around the upper top screw bosses Figure 13 7 Tie wrap Removal 13 Using needle nose pliers disconnect all of the valv...

Page 60: ...from the center housing by pulling it upwards and slipping the compressor Molex connector through the center section Figure 13 9 Removing the PSA Assembly 15 Remove the compressor plate by removing th...

Page 61: ...room air into the bottom of the sieve beds Over time the cup seals may wear and the compressor will not operate properly To replace the compressor follow the steps below 1 Remove the PSA assembly per...

Page 62: ...the manifold from the beds Figure 14 2 Removing the Compressor 4 If either of the two fittings connecting the compressor to the manifold is connected to the compressor remove it and insert it back in...

Page 63: ...e hour meter For a FreeStyle please reference the HOUR METER FUNCTIONALITY section of this manual If replacing the compressor on a FreeStyle 5 you must refer to the instructions for reading and record...

Page 64: ...MN220 1 B 64 Portable Oxygen Concentrator Figure 15 1 Manifold Tubing Figure 15 2 Mixing Tank Tubing Figure 15 3 Purge Tubing...

Page 65: ...uct manifold to remove Keep tubing assembly in place 6 Align the new product manifold with the outlet of the sieve beds and gently push the manifold down into place 7 Reconnect the tubing assembly to...

Page 66: ...refully disconnect the Molex connector from the circuit board by pulling on the Molex connector not the valve wires 5 Using a small Philips screwdriver remove the two screws fastening the valve 6 Remo...

Page 67: ...ld Removal 4 Pull upward on the adsorbent beds to remove them from the feed waste manifold Figure 16 2 Sieve Bed Removal 5 Remove the plugs from the top and bottom of the new adsorbent beds 6 Place a...

Page 68: ...on the new adsorbent beds and gently push down until the o rings are completely seated Figure 16 3 Attaching New Sieve Beds 9 Connect the product manifold to the sieve beds and place the center bolt...

Page 69: ...ing a 5 32 Allen wrench 4 Holding both sieve beds gently pull upwards removing the product manifold and sieve beds Set the product manifold and sieve bed assembly aside keeping the top of the sieve be...

Page 70: ...e Oxygen Concentrator Figure 17 2 Feed Waste Manifold with Fittings 6 Place the new feed waste manifold onto the compressor Gently push the manifold down until the compressor fittings are seated into...

Page 71: ...t the connections from the pressure gauge to the manifold are leak free i Part No KI036 1 Pressure Test Kit gauge and connector and KI340 1 Adaptor 7 Put the unit into test mode Press the 1 and 3 sett...

Page 72: ...range of normal operating pressures at sea level These are approximate pressures A unit may be out of the range shown below and still be within specification for example in higher altitude environment...

Page 73: ...tenance hours to zero Figure 20 Hour Meter The FreeStyle 5 does not have an hour meter on the circuit board Please reference the FREESTYLE 5 HOUR METER FUNCTIONALITY section for more information Hour...

Page 74: ...t To reset the maintenance channel begin with the module in maintenance mode and then press the toggle reset switch for five seconds A reset is indicated by a 0 display HOUR METER REPLACEMENT FOR FREE...

Page 75: ...for three seconds to enter the Time Reading Mode Once in this mode all 5 LEDs will light up and the unit will beep 3 After the unit has entered this mode the hours will be displayed in the following m...

Page 76: ...cate the composite side marked top or the side with the single row connector and properly align the connections Figure 21 2 Aligning Pins to the Connection 6 View the replacement board from the side a...

Page 77: ...ic circuitry 1 Remove the front and back covers per the HOUSING REMOVAL section of this manual 2 Remove the inlet screen 3 Remove the PSA system per the PSA REMOVAL section of this manual 4 Remove the...

Page 78: ...Remove the motor controller board per the MOTOR CONTROLLER BOARD REPLACEMENT section of this manual 8 If replacing the circuit board on a FreeStyle remove the hour meter per the HOUR METER REPLACEMEN...

Page 79: ...it board by using needle nose pliers and carefully pulling upwards on the connector housing on the main circuit board Connection J6 for the FreeStyle or connection J15 for the FreeStyle 5 11 Remove th...

Page 80: ...Concentrator Figure 22 4 Self Tapping Screws 12 Remove the main circuit board from the center section assembly Figure 22 5 Main Circuit Board Removal 13 Replace the main circuit board reverse order o...

Page 81: ...panel keypad flex circuit from the Ziff zero insertion force connector by carefully lifting upward on the locking tabs This is connection J8 for the FreeStyle and connection J9 J10 for the FreeStyle...

Page 82: ...venly to ensure that all adhesive is in contact with the plastic surface Figure 23 2 Adhering New Control Panel 9 Route the flex circuit through the control panel keypad slot Figure 23 3 Control Panel...

Page 83: ...facing toward you 12 Insert into Ziff zero force insertion connector s making sure that the flex circuit seats into the connector Carefully press the Ziff connector locking tab in a downward directio...

Page 84: ...ESD wrist strap to protect electronic circuitry 1 Remove the PSA system per the PSA REMOVAL section of this manual 2 Disconnect the Molex connector from the circuit board to the fan Figure 24 1 Fan M...

Page 85: ...w of the fan For the FreeStyle ensure the two wires coming from the fan are located on the upper left side For the FreeStyle 5 ensure the two wires coming from the fan are located on the upper right s...

Page 86: ...nds 3 If a FreeStyle activate the test mode by pressing flow settings 1 and 3 simultaneously for ten seconds If a FreeStyle 5 activate the test mode by pressing flow settings 1 and 5 simultaneously fo...

Page 87: ...unds and the red alarm light illuminates continuously FreeStyle has not detected a breath for 15 minutes Check the cannula connection Ensure that cannula tubing is not kinked Make sure that the cannul...

Page 88: ...A general malfunction has occurred Change to another source of oxygen as available and contact your Equipment Provider Unit does not start on battery pack power Unit may be hot or cold if left outdoor...

Page 89: ...r DC outlet to reset the breaker within DC power supply For FreeStyle Only No hour meter display Defective hour meter Replace hour meter All other problems Change to another source of oxygen as availa...

Page 90: ...ygen Concentrator ACCESSORIES For proper performance and safety use only these listed accessories supplied by CAIRE Use of accessories not listed below could adversely affect the performance and or sa...

Page 91: ...82 2473 CAIRE Inc 2200 Airport Industrial Drive Suite 500 Ball Ground GA 30107 USA www cairemedical com Copyright 2019 CAIRE Inc CAIRE Inc reserves the right to discontinue its products or change the...