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Summary of Contents for 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 2 PROUDLY ASSEMBLED IN THE U.S.A.
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Page 3: Table Of Contents
Table of Contents SECTION 1: INTRODUCTION ............5 ..................6 NTENDED ..................6 ROFILE ................7 YMBOLS EFERENCE Information/Safety Symbols ............7 Device Symbols ................8 ................... 9 PECIFICATIONS ................. 10 ONTRAINDICATIONS ................ 12 NDICATIONS FOR ............. 13 YNAMIC ETWORK NALYSIS SECTION 2: SAFETY GUIDELINES ............ - Page 4 ................55 ATTERY ISPOSAL SECTION 7: TRAVELING ..............56 ..........57 CCESSING THE IRPLANE CREEN SECTION 8: STANDARDS COMPLIANCE .......... 58 ................. 59 LASSIFICATION ® OXLIFE FREEDOM – LIMITED WARRANTY STATEMENT ....64 PRODUCT RETURN GUIDELINES ............ 67 NOTES ................... 68...
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Page 5: Section 1: Introduction
SAFETY PRECAUTIONS OR OPERATING INSTRUCTIONS CONTACT YOUR AUTHORIZED DEALER OR HEALTHCARE PROVIDER FOR TECHNICAL SUPPORT. Please contact your authorized dealer or healthcare provider if your Oxlife Freedom requires service. ® Please call O2 Concepts Customer Service to report any unexpected operation or events associated with the device at 1-800-867-4008 EXT 331. -
Page 6: Intended Use
The Freedom detects a patient’s breath and delivers a bolus of oxygen during the inhalation period. The Freedom can be set to deliver flowrates in Settings 1-5 of 8ml – 40ml. Setting can be adjusted in increments of 1. The Freedom has standard power options including a 100- 240V AC power supply, 10-15V DC power supply and a rechargeable lithium ion battery. -
Page 7: Symbols Reference
Keep dry in Refer to transport and instructions storage Type BF Class II equipment equipment Recycle Prescription only battery Drip proof Manufacturer equipment Alternating Direct current current *This refers to AC and DC power supplies, not the Freedom device. -
Page 8: Device Symbols
Device Symbols ICON MEANING ICON MEANING Power button Cell connected Menu button GPS signal Increase flow RDM connected setting (Tech Support Only) Decrease flow RDM mode setting (Tech Support Only) Battery life Alarm indication AC/DC charging Breath detection indicator Cell signal Device status strength Exit... -
Page 9: Specifications
Specifications H: 9.4” (23.87cm) W: 9.0” (22.86 cm) Device Dimensions D: 3.4” (8.63cm) Device Weight 4.53 lbs. (2.05kg) Battery Weight 1.35 lbs. (0.61 kg) AC Charger Weight 1.2 lbs. (0.54 kg) DC Charger Weight 1.4 lbs. (0.63 kg) 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 This device is not qualified for use by patients with a tracheotomy. This device is not intended to be used in conjunction with a humidifier or nebulizer or connected to any other equipment. Use of this device with any other equipment may damage the device or impair device performance and will void the warranty.
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Page 12: Indications For Use
Indications for Use 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 13: 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 14: 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... - Page 15 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30cm) to any part of the Oxlife Freedom including cables ® specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 16: 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 17 ® have been individually determined or prescribed by a physician for you at your specific activity levels. The Freedom must be used with the specific combination of parts and accessories that were used while your settings were determined. Use only water-based lotions or salves that are oxygen- compatible before and during oxygen therapy.
- Page 18 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. Consult your healthcare provider if you are feeling unwell, which may indicate either too much or too little oxygen.
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Page 19: 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 20 DO NOT attempt to disassemble the battery or power supply. Doing so will void the warranty and may cause injury. DO NOT short circuit the battery's metal contacts with metallic objects such as keys or coins. It may cause electrical shock, sparks or excessive heat. DO NOT use the battery or power supply for anything other than its intended purpose.
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Page 21: 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... - Page 22 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 23 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.
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Page 24: Applied Parts
Applied Parts 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 › External Power Input ›... -
Page 25: Section 4: Operating Instructions
This equipment should be installed and placed into service in accordance with the information provided in the accompanying documents. DO NOT operate the Freedom without first reading the Safety Guidelines included in SECTION 2 of this manual. Please follow all operating instructions. -
Page 26: Locating Your Device
DO NOT operate the device in an enclosed space, such as a closet. 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. -
Page 27: Device Settings
Device Settings Turn the device on by pressing the Power button. Press the Increase or Decrease buttons to select the desired flow rate. Turn the device off by pressing the Power button. THE PROPER FLOW FATE IS PRESCRIBED BY YOUR PHYSICIAN. DO NOT CHANGE THESE SETTINGS WITHOUT CONSULTING WITH YOUR PHYSICIAN. -
Page 28: Installing And Removing The Battery
22.9 12.0 16.0 20.0 Respiratory efforts of the patient may not trigger a bolus. 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 29: Single-Pack Battery Operation Times
Single-Pack Battery Operation Times Setting Operating Time 4 hours 3 hours 30 minutes 3 hours 2 hours 1 hour 45 minutes 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 30: Battery Time Management
Battery Time Management The Oxlife Freedom is equipped with a rechargeable lithium ® ion battery that is NOT user serviceable. The battery utilized with this device will degrade over time and from standard use; provided however, the rate of such... - Page 31 Charge batteries every three (3) months when not in › use. There is no routine maintenance or service required for the Oxlife Freedom rechargeable batteries other than the ® periodic replacement as described above.
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Page 32: Ac Power Supply
AC Power Supply Use only the AC power supply (800-1048) provided with this device. Use of power cords not supplied by O2 Concepts may cause overheating or damage to the device and will void the warranty. The power supply is not water resistant. DO NOT place anything in the power supply port other than the supplied AC or DC power cords. - Page 33 To use the AC power supply, connect the power cord to the AC power converter (brick). Then connect the power supply to a wall outlet and the Freedom. The external power source icon will be displayed on the control panel.
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Page 34: Dc Power Supply
DC Power Supply The DC power supply allows a patient to operate the Oxlife Freedom from a vehicle's 12/15-volt DC outlet in all settings. ® A 12-volt, 10-amp outlet is recommended for use with the device. To use the DC power supply, connect the power cord to the DC power converter (brick). -
Page 35: Starting The Device On Dc Power
Use no other DC outlets in the vehicle while your Oxlife Freedom is in use. ® Recommendations for Use: When operating the Oxlife Freedom in your vehicle, ensure ® that the device is securely stowed and will not be damaged during transport. -
Page 36: Dc Power Supply Troubleshooting Guide
DC Power Supply Troubleshooting Guide Event Solution If there is no charging icon (lightning › bolt symbol), reduce the device to Batteries Not Setting 1 and wait for charging icon to Charging appear. Next, increase the flow rate by 1 setting ›... -
Page 37: Carry Bag
Carry Bag The Freedom carry bag provides protection and allows you to easily take your device with you for your daily activities. Always use your Oxlife Freedom in the supplied carry bag. ® Check that the adjustable shoulder strap is secure, and the battery access zipper is closed before each use. -
Page 38: Accessory Bag
Accessory Bag The Accessory Bag is designed to carry your Oxlife Freedom ® accessories including an extra battery, AC power supply and DC power supply... -
Page 39: 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 40 DO NOT use grease or oils to lubricate the oxygen outlet port. Read and follow the instructions included with the cannula and follow the instructions provided by your authorized dealer or healthcare provider. Clean and replace your cannula regularly as instructed by the manufacturer and your authorized dealer or healthcare provider.
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Page 41: 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 (3) 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 42: Alarm And Alert Screen Descriptions
Alarm and Alert Screen Descriptions Alarms The LCD screen will be RED in Alarm Mode No Breath Alarm When the device has not detected a breath for 45 (physiological) seconds, the screen will turn red, sound one beep (low priority) per 30 seconds and the text “No Breath”... - Page 43 15 seconds has expired at which time the device will power off. What to do: Connect to an authorized O2 Concepts Freedom power supply. Low External When the voltage from an external power source...
- Page 44 What to do: Remove unauthorized battery and replace with an authorized O2 Concepts Freedom battery. Over The maximum operating temperature of the Temperature enclosure and pump is 70°C. If either of these...
- Page 45 What to do: Relocate the device to improve airflow or to a cooler environment and allow the device to reach operating temperature. Utilize an alternate source of oxygen if necessary and contact your authorized dealer. Invalid Box When the internal box temperature is out of a valid Temperature range for 15 seconds, the screen will flash red at Alarm...
- Page 46 Alerts The LCD screen will be AMBER in Alert Mode No Breath Alert When the device has not detected a breath for 45 (technical) seconds, the screen will turn amber, sound one (low priority) beep per 30 seconds and the text “No Breath” will flash in the system status window.
- Page 47 Pushing the Menu (M) button once silences the alert. What to do: Remove unauthorized battery and replace with an authorized O2 Concepts Freedom battery. Low External When the voltage from an external power source Power Alert falls to 18 volts or less (as measured by the device...
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Page 48: 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 49 concluded. Pressing the Menu button (M) while the Medium Priority Alarm test is in progress will terminate the Medium Priority Alarm test and start the Low Priority Alarm. The Low Priority Alarm consists of one (1) beep and a solid amber LCD screen.
- Page 50 Accessing the Provider Screen The provider screen shows information about the device status and run hours. To access the provider screen: Press the Menu(M) button. › Press the Plus(+) button or Minus(-) button to scroll › to the provider screen icon. To enter and exit the provider screen, press the ›...
- Page 51 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 power supply. (example: VIN: 23.8 where 23.8 is in volts) Run Hours: The run hours are the total life hours the device has run. (example: Run Hrs: 22, where the device has been run a total of 22 hours)
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Page 52: Section 6: Maintenance And Cleaning
Any such attempt will void the warranty. Pre-Use Functional Check A trained service technician can qualitatively verify that the Freedom is ready for use by performing the following protocols: Connect the nasal cannula to the cannula port. ›... -
Page 53: Device Care And Cleaning
Routine cleaning of the air inlet filter as described below and periodic cleaning of the exterior of the device is the only routine maintenance. To keep your Oxlife Freedom working properly, it is ® recommended to clean the air inlet filters weekly. If the... -
Page 54: Cleaning
Cleaning Unplug your Freedom before cleaning. Do not submerge your device or any accessories or allow water to enter the device. Clean the exterior of your device using a soft cloth dampened with a mild detergent and water and wipe dry. -
Page 55: 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 56: Section 7: Traveling
(C) the duration of your flight; and (D) any unexpected delays. Please be aware that battery requirements may vary based upon Freedom use at the prescribed flow rate. Use requirements may also be affected by the aircraft cabin environment. -
Page 57: 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 58: Section 8: Standards Compliance
Section 8: Standards Compliance This device is designed to comply with the following standards: IEC 60601-1 2005 Ed.3+A1; Medical Electrical Equipment; Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-2 4th Edition; Medical Electrical Equipment, Part 1-2: General Requirement for Safety – Collateral Standard: Electromagnetic (EMC) Compatibility IEC 60601-1-6:2010 Ed3+A1 Medical Electrical Equipment –... -
Page 59: Classification
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 ›... - Page 60 The Oxlife Freedom Portable Oxygen Concentrator is intended for use in the electromagnetic ® environment specified below. The customer or the user of the Oxlife Freedom Portable Oxygen ® Concentrator should assure that it is used in such an environment.
- Page 61 The Oxlife Freedom Portable Oxygen Concentrator is intended for use in the electromagnetic ® environment specified below. The customer or the user of the Oxlife Freedom Portable Oxygen ® Concentrator should assure that it is used in such an environment.
- Page 62 Test Specification for Enclosure Port Immunity to RF Wireless Communications Equipment The concentrator is intended for use in an environment where the radiated RF disturbances are controlled. Do not use the device near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
- Page 63 LISA-C200 Parameter Module Unit Remarks Frequency LISA-C200 Uplink Module transmit range LISA-C200 Downlink Module receive CDMA 800 Frequency LISA-C200 Uplink 1850 1910 Module transmit range LISA-C200 Downlink 1930 1990 Module receive CDMA 1900 SARA-R410 Parameter Unit Remarks Frequency range Uplink Module transmit FDD Band 12 (700 MHz) Downlink...
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Page 64: Oxlife Freedom ® - Limited Warranty Statement
OXLIFE FREEDOM – 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... - Page 65 within the warranty period. Products may be returned only by Purchaser and only when accompanied by an RMA reference number issued by the Company (see PRODUCT RETURN GUIDELINES at the end of this Statement). The Company will not be responsible for any alleged breach of warranty for which the Company determines to have arisen from a cause not covered by this warranty including, but not limited to, those exceptions listed below.
- Page 66 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 parts, materials and accessories not provided or authorized by the Company;...
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Page 67: Product Return Guidelines
Material Authorization (“RMA”) 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 commercially reasonable packing protection. -
Page 68: Notes
NOTES... - Page 72 Oxlife FREEDOM ® O2 Concepts, LLC 199 Park Road Extension Middlebury, CT 06762 USA (877) 867-4008 www.o2-concepts.com ® © 2019 O2 Concepts, LLC, all rights reserved; O2 Concepts , Oxlife ® Freedom , and DNA Technology , including certain related logos, are ®...
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