O2 Concepts, LLC Oxlife FREEDOM User Manual Download Page 11 | Manualshive

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O2 Concepts, LLC Oxlife FREEDOM User Manual Download Page 11

11

Indications for Use

FLOW SETTINGS SHOULD ONLY BE ADJUSTED UNDER THE ADVICE OF A PHYSICIAN.

The Oxlife Freedom is indicated on a prescription basis for the administration of supplemental

oxygen. It is not intended for life support nor does it provide any patient monitoring capabilities.

Federal law restricts this device to sale by or on the order of a physician.

No modification of this equipment is allowed.

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Summary of Contents for Oxlife FREEDOM

Page 1: ...P O R T A B L E O X Y G E N C O N C E N T R A T O R USER READ THIS MANUAL BEFORE OPERATING THIS DEVICE SAVE THIS MANUAL FOR FUTURE REFERENCE HEALTH CARE PROVIDER THIS MANUAL MUST BE PROVIDED TO THE END USER USER MANUAL ...

Page 2: ......

Page 3: ...PROUDLY ASSEMBLED IN THE U S A ...

Page 4: ...TRUCTIONS 21 BEFORE OPERATING 21 LOCATING YOUR DEVICE 21 DEVICE SETTINGS 22 INSTALLING AND REMOVING THE BATTERY 23 TYPICAL BATTERY OPERATING TIMES 23 BATTERY TIME MANAGEMENT 24 AC POWER SUPPLY 25 DC POWER SUPPLY 26 Starting the Device on DC Power 26 Disconnecting the Device from DC Power 27 DC Power Supply Troubleshooting Guide 27 CARRY BAG 28 ACCESSORY BAG 28 CANNULA USE 29 SECTION 5 USER ALERTS ...

Page 5: ...G 40 DEVICE DISPOSAL 41 BATTERY DISPOSAL 41 SECTION 7 TRAVELING 42 ACCESSING THE AIRPLANE MODE SCREEN 43 SECTION 8 STANDARDS COMPLIANCE 44 CLASSIFICATION 44 NOTES 46 OXLIFE FREEDOM LIMITED WARRANTY STATEMENT 47 PRODUCT RETURN GUIDELINES 49 ...

Page 6: ... LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Intended Use The Oxlife Freedom is a portable oxygen concentrator used on a prescriptive basis by patients requiring supplemental oxygen to be treated in a home environment in an institutional environment or in a vehicle mobile environment The device delivers 87 95 pure oxygen to the patient through a standard single lumen nasal ...

Page 7: ... using or near device Not suitable for use in the presence of a flammable anesthetic mixture No open flames Do not incinerate battery Indoor use only Use no grease or oils Do not disassemble Do not dispose of in household waste Refer to instructions Keep dry in transport and storage Type BF equipment Class II equipment Recycle battery Prescription only Drip proof equipment Manufacturer Alternating...

Page 8: ...al Increase flow setting RDM connected Tech Support Only Decrease flow setting RDM mode Tech Support Only Battery life indication Alarm AC DC charging indicator Breath detection Cell signal strength Device status Exit AC DC power Airplane mode Contains Dynamic Network Analysis DNA technology ...

Page 9: ...purity values are within 2 of actual values there is no variation in purity within the operating altitude This applies to the full range of environmental operating conditions Operating Temperature 50 F 10 to 104 FSee 40 C Operating Humidity 10 95 82 4 F 28 C Operating Atmospheric Pressure 101kPa to 63kPa Operating Environment Free of smoke pollutants and fumes363 Transport Storage Temperature 4 F ...

Page 10: ...ability of an alternate source of supplemental oxygen is strongly recommended in the case of power interruption or a mechanical failure of the device Consult your healthcare provider for a recommendation of an alternate source of oxygen It is the patient s responsibility to arrange for an alternate oxygen supply when traveling O2 Concepts assumes no liability for persons choosing not to adhere to ...

Page 11: ... Freedom is indicated on a prescription basis for the administration of supplemental oxygen It is not intended for life support nor does it provide any patient monitoring capabilities Federal law restricts this device to sale by or on the order of a physician No modification of this equipment is allowed ...

Page 12: ...ues to operate within specification This device is FAA approved for use aboard passenger aircraft FAA Advisory Circular 91 21 1B including radio frequency emission limits of RTCA Document DO 160 section 21 Category M Device contains FCC Id R5Q LISAC200A The cellular connection must be deactivated prior to flight on any commercial aircraft Instructions for deactivating the cellular connection are l...

Page 13: ...ds away from hot surfaces and in a manner to prevent tripping hazards DO NOT operate the device in an enclosed space such as a closet as it may impair device function DO NOT cover the device or block the air inlet or the exhaust ports located on the back of the device as it may impair device function DO NOT leave your Oxlife Freedom or batteries in your vehicle or its trunk Extreme heat or cold ma...

Page 14: ... of the oxygen concentrator or any oxygen carrying accessories Oxygen makes it easier for a fire to start and spread DO NOT leave the nasal cannula or mask on bed coverings or chair cushions If the oxygen concentrator is turned on but not in use the oxygen will make the materials flammable Turn the oxygen concentrator off when not in use to prevent oxygen enrichment SMOKING DURING OXYGEN THERAPY I...

Page 15: ...umidity ranges is expected to adversely affect the flowrate and the percentage of oxygen and consequently the quality of oxygen therapy Consult your healthcare provider if you are feeling unwell which may indicate either too much or too little oxygen If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy seek medical assistance immediately to avoid harm ...

Page 16: ...n DOT and United Nations UN regulations require that the battery be removed from the device when checked as luggage on international flights The battery may explode if exposed to or disposed of in a fire Keep the battery away from children to prevent injury DO NOT drive over drag or place objects on the power cords to avoid damage Use of a damaged battery or power supply may cause personal injury ...

Page 17: ...pose the battery to water or other liquids If battery gets wet discontinue use and dispose of properly to avoid personal injury DO NOT expose the battery to excessive heat or cold as it may affect performance Use caution when handling the DC plug adapter This plug may get hot with use Ensure the DC plug socket is clean of debris which may cause overheating ...

Page 18: ...t to ISO 80601 2 69 Medical Electrical Equipment Particular requirement for basic safety and essential performance of oxygen concentrator equipment The configuration of the equipment and accessories must be determined for each individual patient This manual applies to the following accessories Battery AC Power Supply DC Power Supply Carry Bag Accessory Bag Cannula not included This manual does not...

Page 19: ...cation 1 Control Panel 2 LCD Display 3 Oxygen Outlet Port 4 Exhaust Port 5 Rechargeable Battery 6 External Power Input 7 Air Inlet Ports Air Inlet Filters 8 Device Serial Number 9 FAA Approval Statement 1 2 3 4 5 6 7 8 9 ...

Page 20: ... Alarm Indication 20 Breath Detection 21 Green Status Circle Open Circle during warm up Filled circle indicates flow and purity are within specifications 22 External Power Source 23 Increase Decrease Scroll Buttons 24 Device Setting The applied parts or components that a patient will come in contact with during normal operation of the device are listed below Control Panel Oxygen Outlet Port Extern...

Page 21: ...device performance and will void the warranty See Operating Temperature and Operating Humidity ranges listed in the Specifications Table Fully charge batteries before first use Locating Your Device Place the Oxlife Freedom in a well ventilated area free of smoke fumes pollutants and away from direct sun light Avoid high humidity environments Use only the supplied carry bag when ambulating with you...

Page 22: ...te or life threatening When the device is powered on it will enter a seven 7 minute warm up period to reach desired performance The warm up period is indicated on the display screen by a green ring that becomes a green circle once warm up is complete The device will detect your breath and supply a measured pulse of oxygen or bolus The breath detect icon will flash on the control panel with each br...

Page 23: ...urn off the device before removing the battery DO NOT use the Oxlife Freedom without a battery installed Typical Battery Operating Times Setting Operating Time 1 4 hours 2 3 hours 30 min 3 3 hours 4 2 hours 5 1 hour 45 min Battery operating times are based on a new fully charged battery Battery operating time will degrade with battery age number of charge cycles and operating environment ...

Page 24: ...r located on the top of the battery below the label Press the red button on the battery to display the remaining battery life in 25 increments BEFORE PRESSING RED BUTTON AFTER PRESSING RED BUTTON The typical time to recharge a fully discharged battery is approximately 1 5 hours with the device plugged into AC power and powered off Battery charge times while the device is running will vary dependin...

Page 25: ... device AC power input cable When powered a green LED on the power supply will be illuminated The AC power supply charges the battery using a 100 240V 50 60 Hz outlet a typical wall outlet in your home Using the AC power supply allows you to use your Oxlife Freedom while simultaneously charging the battery To use the AC power supply connect the power supply to a wall outlet and the Oxlife Freedom ...

Page 26: ... POWER CHARGING CAPABILITY VARIES CONSIDERABLY AMONG VEHICLE MANUFACTURERS When operating the Oxlife Freedom in your vehicle ensure that the device is securely stowed and will not be damaged during transport Ensure that air inlet and exhaust ports are not blocked Note that batteries will not charge at any setting if the engine is not running DO NOT leave the device plugged into the vehicle when th...

Page 27: ...ing charged to 10 before the lightning bolt appears on the display Device Alerting Beeping Intermittently If the DC power drops equal to or below 11 5 volts the device will beep The device will switch to battery power The device will automatically return to DC power once the vehicle supplies the proper voltage The device will default to the most reliable source of power to supply oxygen Low Extern...

Page 28: ...ss zipper is closed before each use The Oxlife Freedom is inserted into the carry bag from the bottom zippered section of the carry bag Ensure that exhaust and intake ports are aligned with the mesh panels and access zipper is closed The battery can be accessed via the zipper without removing the device from the carry bag Accessory Bag The Accessory Bag is designed to carry your Oxlife Freedom acc...

Page 29: ... longer than 7 feet 2 13m Nasal cannula should be rated for 8 liters per minute to ensure proper oxygen delivery To ensure proper oxygen flow confirm that the cannula is not pinched or blocked in any way DO NOT use grease or oils to9 lubricate the oxygen outlet port Read and follow the instructions included with the cannula and follow the instructions provided by your authorized dealer or healthca...

Page 30: ... that are greater than ten 10 seconds inherent to specific alarms and these delays are explained in detail for each alarm in the following tables To ensure that audible alarm notifications are heard the maximum distance the user can be from the device is dependent on surrounding noise levels When two alarm conditions occur at the same time the higher priority condition will be displayed DO NOT IGN...

Page 31: ...e power button is held to power off the unit or 15 seconds has expired at which time the device will power off What to do Clean or replace air inlet filter Change to another source of oxygen and contact your authorized dealer Low Battery Alarm technical high priority When battery power is depleted the pump shuts off the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5 secon...

Page 32: ... red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text Over Temperature will flash in the system status window The device will continue to sound until the Menu M button is pressed to silence the audio the power button is held to power off the device or 15 seconds has expired at which time the device will power off What to do Ensure that device has proper ventilatio...

Page 33: ...ce and the text Invalid Flow will flash in the system status window The device will continue to sound until the Menu M button is pressed to silence the audio the power button is held to power off the device or 15 seconds has expired at which time the device will power off What to do Change to another source of oxygen and contact your authorized dealer DO NOT IGNORE ALERTS OR ALARMS ...

Page 34: ... time reaches 6 minutes remaining the screen will turn amber sound one beep every 30 seconds and the text ALERT Low Battery will flash in the system status window Pushing the Menu M button once silences the alert What to do Connect to an external power source Replace depleted battery with a charged battery Unauthorized Battery Alert technical medium priority If the device detects that a battery ot...

Page 35: ...ity Alarm test is in progress will terminate the High Priority Alarm test and start the Medium Priority Alarm The Medium Priority Alarm consists of a 3 beep sequence separated by 15 seconds of silence and the LCD screen will flash amber The alarm symbol will appear on the screen The device will automatically enter the Low Priority Alarm test once the Medium Priority Alarm sequence has concluded Pr...

Page 36: ...tton Press the Plus button or Minus button button to scroll to the Provider Screen icon Cell Status and Signal Strength The cell status is listed in the eighth row example Cell Enabled The cell signal strength is listed in the third row on a scale of 0 31 example Sg 29 Voltage In Voltage In is the voltage that the device is receiving from an external power source such as the AC power Supply or DC ...

Page 37: ... Alert state which will trigger an auto pulse The technician should be able to hear the bolus of oxygen by placing the outlet of the nasal cannula near his or her ear do not direct the flow straight into ear to avoid discomfort The technician should be able to feel the flow of oxygen by placing a finger roughly one half inch from the outlet of the nasal cannula Place the end of the nasal cannula i...

Page 38: ...AC and DC Power Supplies and Cords Unplug your Oxlife Freedom and or power supply before cleaning Clean the power supplies and cords using a soft cloth dampened with a mild detergent and water and wipe dry ...

Page 39: ...e Air Inlet Filters 1 Remove the Air Inlet Filters 2 Wash the filters by running under warm tap water using a mild detergent 3 Rinse thoroughly under warm running water 4 Squeeze out excess water 5 Allow Air Inlet Filters to dry 6 It is important to allow the Air Inlet Filters to dry completely before reinserting into the device Moisture from a wet or damp Air Inlet Filter may damage your device N...

Page 40: ...Bag 1 The carry bag can be cleaned using a damp cloth or by washing in a washing machine alone on a gentle cycle using cold water and a mild detergent 2 Allow to air dry 3 Ensure carry bag is completely dry before use Cannula Cleaning Clean and replace the cannula as instructed by the manufacturer and your healthcare provider ...

Page 41: ...ocal governing ordinances and recycling plans regarding disposal of the device Battery Disposal The battery is rechargeable and can be recycled Always return batteries to your healthcare provider or an authorized dealer for proper disposal You can also contact your local government offices for proper disposal instructions for a lithium ion battery ...

Page 42: ...quire advanced submission of a medical verification statement from your physician You should confirm any notification and verification requirement with your specific carrier Not all air carriers provide an electrical outlet aboard the aircraft so you should have sufficient batteries or confirmed alternative power source to account for at least 150 of your total travel time including but not limite...

Page 43: ...n 3 Press Menu button M to enter Airplane Mode menu 4 Press Plus button to activate to Airplane Mode 5 Press Menu button M key to select displayed mode 6 Press Plus button to confirm or Minus button to cancel 7 Press Plus button or Minus button to scroll to Home icon 8 Press Menu button M to return to Home screen The device will exit Airplane Mode after 24 hours have passed or the user manually re...

Page 44: ...dard Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment ISO 80601 2 67 Issued 2014 06 01 Ed 1 Medical Electrical Equipment Part 2 67 Particular Requirements for Basic Safety and Essential Performance of Oxygen Conserving Equipment ISO 80601 2 69 Issued 2014 07 15 Ed 1 Medical Electrical Equipment Part 2 69 Particular Requirements fo...

Page 45: ... be minimized by maintaining the distances described below based on the output of the equipment below If the system is compromised due to excessive RF disturbances an alert or alarm condition may occur and the device may power off RF cell frequencies used by this equipment include Lisa Sarah RF GPS frequencies used by this equipment include ...

Page 46: ...46 NOTES ...

Page 47: ...r any limited warranty set forth herein to be effective Purchaser shall inspect each Product within two 2 days of delivery and before such Product is placed into use Purchaser agrees that the warranties provided by the Company with respect to any Product are subject to use of the Product in accordance with the Company s instructions as provided and that failure to do so shall void the warranties T...

Page 48: ...o smoke including cigarette cigar or e cigarette smoke Ingress of liquids sand dirt food insects animals or other foreign objects into the Product Exposure to unusual electrical stress heat humidity condensation and or cold Use in a manner that constitutes abnormal usage or conditions Failure to follow recommended preventative maintenance Unauthorized installation repair or modification Use of par...

Page 49: ...s shall jointly select an arbitrator In the event the parties fail to agree upon an arbitrator within ten 10 days then the Company shall select an arbitrator and Purchaser shall select an arbitrator and such arbitrators shall then select a third arbitrator to serve as the sole arbitrator provided that if either the Company or Purchaser in such event fails to select an arbitrator within seven 7 day...

Page 50: ...762 877 867 4008 www o2 concepts com 2018 O2 Concepts LLC all rights reserved O2 Concepts Oxlife Freedom and DNA Technology including certain related logos are registered trademarks of O2 Concepts LLC and may not be replicated without express written consent PN 800 1049 Rev A ...

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