O2 Concepts, LLC Oxlife FREEDOM User Manual
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O2 Concepts, LLC Oxlife FREEDOM User Manual

Portable oxygen concentrator
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Oxlife FREEDOM
USER MANUAL
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.
®

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Summary of Contents for O2 Concepts, LLC Oxlife FREEDOM

  • Page 1 Oxlife FREEDOM USER MANUAL 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.
  • Page 3 PROUDLY ASSEMBLED IN THE U.S.A.

  • Page 4: Table Of Contents

    Table of Contents SECTION 1: INTRODUCTION .............................. 6 ..................................6 NTENDED ................................. 7 YMBOLS EFERENCE Information/Safety Symbols ............................. 7 Device Symbols ................................. 8 ..................................9 PECIFICATIONS ................................10 ONTRAINDICATIONS ................................11 NDICATIONS FOR ..............................12 YNAMIC ETWORK NALYSIS SECTION 2: SAFETY GUIDELINES ............................13 ...............................
  • Page 5 .................................. 41 ATTERY ISPOSAL SECTION 7: TRAVELING ..............................42 ............................ 43 CCESSING THE IRPLANE CREEN SECTION 8: STANDARDS COMPLIANCE ..........................44 ..................................44 LASSIFICATION NOTES ..................................... 46 OXLIFE FREEDOM – LIMITED WARRANTY STATEMENT ....................47 PRODUCT RETURN GUIDELINES ............................49...

  • Page 6: Section 1: Introduction

    Please call O2 Concepts Customer Service to report any unexpected operation or events associated with the device at 1-800-867-4008 EXT 331. Information about the Oxlife Freedom and O2 Concepts can also be found on our website at www.o2-concepts.com CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

  • Page 7: Symbols Reference

    Symbols Reference Information/Safety Symbols ICON MEANING ICON MEANING Warning represents the possibility Caution represents the possibility of harm to the operator or of damage to the equipment patient Not suitable for use in the No smoking while using or near presence of a flammable device anesthetic mixture...

  • Page 8: Device Symbols

    Device Symbols ICON MEANING ICON MEANING Power button Cell connected Menu button GPS signal RDM connected Increase flow setting (Tech Support Only) RDM mode Decrease flow setting (Tech Support Only) Battery life indication Alarm AC/DC charging indicator Breath detection Cell signal strength Device status Exit AC/DC power...

  • Page 9: Specifications

    Specifications DIMENSIONS Device Dimensions H: 9.4” (23.87cm) W: 9.0” (22.86 cm) D: 3.4” (8.63cm) WEIGHTS Device 4.53 lbs. (2.05kg) Battery 1.35 lbs. (0.61 kg) AC Charger 1.2 lbs. (0.54 kg) DC Charger 1.4 lbs. (0.63 kg) MODES OF OPERATION Flow Control Settings 5 Settings: 1 to 5 Breathing Frequency Up to 40 Breaths per Minute (BPM)

  • Page 10: Contraindications

    If the patient exhibits signs of discomfort, consult a physician immediately. The Oxlife Freedom is contraindicated for any patient who would experience adverse health consequences as the result of a temporary interruption in oxygen therapy.

  • Page 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.

  • Page 12: Dynamic Network Analysis

    Dynamic Network Analysis Your Oxlife Freedom device may contain Dynamic Network Analysis (DNA) technology which is available to allow your healthcare provider to better serve your needs. This technology is intended to assist your provider in determining that your device continues to operate within specification.

  • Page 13: Section 2: Safety Guidelines

    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 may damage your device and/or batteries.

  • Page 14: Patient Safety Guidelines

    DO NOT operate the device on wet surfaces or in standing water and do not submerge or expose to water or precipitation to avoid serious injury or damage to the device. If the Oxlife Freedom has been dropped, damaged or exposed to water, please contact your authorized dealer or healthcare provider for inspection and possible repair of the device.
  • Page 15 Replace cannula as recommended by manufacturer. Cannulas may become contaminated with body fluids or expired gases during use. Use of this device outside of the stated altitude, temperature or humidity ranges is expected to adversely affect the flowrate and the percentage of oxygen and, consequently, the quality of oxygen therapy.

  • Page 16: Battery And Power Supply Safety Guidelines

    Battery and Power Supply Safety Guidelines Use of an unauthorized battery, AC or DC power supply or power supply cable may cause serious damage to the device and will void the warranty. Use of an unauthorized AC or DC power supply or power supply cable could result in increased electromagnetic emissions or decreased electromagnetic immunity of the equipment and result in improper operation.
  • Page 17 DO NOT drop the battery or expose it to mechanical shock. If battery is damaged, discontinue use and dispose of properly to avoid personal injury. DO NOT expose the battery to water or other liquids. If battery gets wet, discontinue use and dispose of properly to avoid personal injury.

  • Page 18: Section 3: Product Description

    Section 3: Product Description Device and Accessories A humidifier is not recommended for use with the Oxlife Freedom and may impair performance. Your physician, healthcare provider or authorized dealer will recommend the proper cannula for your use. Ensure that selected cannula is compliant to ISO 80601-2-69 Medical Electrical Equipment, Particular requirement for basic safety and essential performance of oxygen concentrator equipment.

  • Page 19: Feature Identification

    Feature Identification 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...

  • Page 20: Understanding The Control Panel

    Understanding the Control Panel 10. Battery Status/Battery Charging Indicator 11. Menu Button 12. Power Button 13. Cell Signal Strength 14. Airplane Mode 15. Cell Connected 16. GPS Signal 17. RDM Connected (Tech Support Only) 18. RDM Mode (Tech Support Only) 19.

  • Page 21: Section 4: Operating Instructions

    DO NOT locate the Oxlife Freedom near any flammable materials or cleaning products or in the direct path of any heat source such as a stove, heat register or car heater. Keep the Oxlife Freedom at least ten (10) feet (1.6 m) from hot sparking objects or open flame.

  • Page 22: Device Settings

    13.7 18.3 22.9 12.0 16.0 20.0 The settings of the Oxlife Freedom might not correspond with continuous flow oxygen. The settings of other models or brands of oxygen therapy equipment do not correspond with the settings of the Oxlife Freedom.

  • Page 23: Installing And Removing The Battery

    To remove battery, depress button and slide battery toward you. To install battery, align battery with device and slide until battery clicks into place. Turn off the device before removing the battery. DO NOT use the Oxlife Freedom without a battery installed. Typical Battery Operating Times Setting...

  • Page 24: Battery Time Management

    The Oxlife Freedom battery also includes a battery charge status indicator 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.

  • Page 25: Ac Power Supply

    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. The external power source icon will be displayed on the control panel.

  • Page 26: Dc Power Supply

    Use the DC outlet closest to the car’s battery. USE NO OTHER DC OUTLETS IN THE VEHICLE WHILE YOUR OXLIFE FREEDOM IS IN USE. IF YOUR VEHICLE’S DC POWER DROPS BELOW 11.5 VOLTS, THE DEVICE WILL REVERT TO BATTERY POWER. A DC OUTLET SUPPLYING A MINIMUM OF 10 AMPS AT 12 VOLTS (120 WATTS) IS RECOMMENDED FOR USE WITH THE DEVICE.

  • Page 27: Disconnecting The Device From Dc Power

    Disconnecting the Device from DC Power 1. Disconnect the DC power cord from the device. The device will beep once and switch to battery power. 2. The battery icon will be displayed on the control panel. The DC Power Supply can run and charge the device on all settings. DC Power Supply Troubleshooting Guide Event Solution...

  • Page 28: Carry Bag

    Check that the adjustable shoulder strap is secure, and the battery access 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.

  • Page 29: Cannula Use

    Cannula Use Connect the cannula to the oxygen outlet port. The cannula fitting may be tight. Your physician, healthcare provider or authorized dealer will recommend the proper cannula for your use. Ensure that selected cannula is compliant to ISO 80601-2-69 Medical Electrical Equipment, Particular requirement for basic safety and essential performance of oxygen concentrator equipment.

  • Page 30: Section 5: User Alerts And Alarms

    Section 5: User Alerts and Alarms The functionality of the alarm system is verified automatically by the unit upon start up by the unit flashing three visual display colors and audible indicators. There will be delays 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.

  • Page 31: Alarm And Alert Screen Descriptions

    15 seconds has expired at which time the device will power off. What to do: Connect to an authorized O2 Concepts Oxlife Freedom power supply.
  • Page 32 Alarms/Red Screens (continued) Low External Power When the voltage from an external power source falls below 17 volts (as Alarm measured by the device internally), the screen will flash red at 2Hz, sound a (technical) 10-beep sequence repeated after 2.5 seconds of silence and the text “Low (medium priority) External Power”...
  • Page 33 Invalid Flow Alarm When the pulse volume is out of a valid range by 15% for 60 seconds the screen will flash red at 2Hz, sound a 10-beep sequence repeated after 2.5 seconds of silence and the text “Invalid Flow” will flash in the system status window.
  • Page 34 Alerts The LCD screen will be AMBER in Alert Mode No Breath Alert When the device has not detected a breath for 45 seconds, the screen will turn amber, sound one beep per 30 seconds and the text “No Breath” will flash in the system status window.

  • Page 35: Accessing The Alarm System Test

    Accessing the Alarm System Test Use this test to verify that the alarm system is working properly. This test includes screen color, screen flashing sequence, and audible alarm sequence. Follow the steps in the procedure listed below. Press the Menu (M) button. Press the Plus button (+) or Minus button (-) button to scroll to the Alarm Test icon.
  • Page 36 Accessing the Provider Screen The provider screen shows information about the Cell Status and Signal Strength and the voltage that the device is receiving from an external power source, such as AC power supply or DC power supply. Press the Menu (M) button. Press the Plus button (+) or Minus button (-) button to scroll to the Provider Screen icon.

  • Page 37: Section 6: Maintenance And Cleaning

    Routine cleaning of the air inlet filters, as described below, is the only routine maintenance required. The Oxlife Freedom requires maintenance after five (5) years of service or as determined by your healthcare provider. There is no routine maintenance or service to the Oxlife Freedom rechargeable batteries, though battery life will vary depending on age and use.

  • Page 38: Ac And Dc Power Supplies And Cords

    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: Air Inlet Filter Cleaning

    Regular cleaning of the Air Inlet Filters is the only maintenance you will perform on your device. To keep your Oxlife Freedom working properly, it is recommended to clean the Air Inlet Filters weekly. If the Oxlife Freedom is used in a dusty environment, more frequent cleaning of the Air Inlet Filters may be required.

  • Page 40: Carry Bag Cleaning

    Carry Bag Cleaning Remove the device from the carry bag before cleaning. Follow these simple directions to clean the Carry 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.

  • Page 41: Device Disposal

    Device Disposal This product may contain substances that could be harmful to the environment if inappropriately disposed of in landfills. Follow local 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.

  • Page 42: Section 7: Traveling

    Section 7: Traveling Before traveling, be sure to pack the following: Carry Bag › AC Power Supply › DC Power Supply › Fully Charged Battery (and extra batteries if required) › Also, bring contact information for your healthcare provider, authorized dealer and/or physician. When traveling internationally, a standard international power plug adapter is required.

  • Page 43: Accessing The Airplane Mode Screen

    Accessing the Airplane Mode Screen The cellular connection must be deactivated prior to flight on any commercial aircraft. To enter and exit Airplane Mode, follow the steps listed in the procedure below. 1. Press Menu button (M) 2. Press Plus button (+) to scroll to Airplane Mode icon 3.

  • Page 44: Section 8: Standards Compliance

    RTCA, DO 160, Section 21, Category M; Emission of Radio Frequency Energy ISO 13485:2016 Medical Devices; Quality Management Systems; Requirements for Regulatory Purposes Classification The O2 Concepts Oxlife Freedom is classified as: IEC Class II Internally Powered Equipment › Type BF Applied Part ›...
  • Page 45 This concentrator is intended for use in an environment where the radiated RF disturbances are controlled. Electromagnetic interference can 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.

  • Page 46: Notes

    NOTES...

  • Page 47: Oxlife Freedom - Limited Warranty Statement

    – LIMITED WARRANTY STATEMENT ® O2 Concepts, LLC (the "Company") warrants that each new Oxlife Freedom® and the related accessories and replacement parts (each a “Product” and collectively, the “Products”), in each case purchased from the Company or its authorized distributor, shall be free from defects in materials and workmanship under normal use and service and when correctly maintained for the periods shown from the date of shipment ("Original Shipment Date") to the original purchaser ("Purchaser"), except as...
  • Page 48 return of the failed Product. The Company will cover the shipping cost of the failed Product to the Company as well as the shipment of the replacement Product to the Purchaser. Purchaser will not be charged for the replacement Product provided Purchaser returns the failed Product in accordance with the Company's instructions within ten (10) business days of the issuance of an RMA reference number and the Company determines that such Product is covered by the limited warranty hereunder.

  • Page 49: Product Return Guidelines

    › reference number before returning any Product. The RMA reference number must be clearly identified on the outer shipping box. › The Oxlife Freedom may only be returned in its original shipping box or a similar container with ® ›...
  • Page 50 © 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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