O2 Concepts, LLC Oxlife FREEDOM User Manual

®
USER MANUAL
PORTABLE OXYGEN CONCENTRATOR
USER: READ THIS MANUAL BEFORE OPERATING THIS DEVICE.
SAVE THIS MANUAL FOR FUTURE REFERENCE.
HEALTH-CARE PROVIDER: TH IS MANUAL M UST BE PROVIDED TO THE END USER.
PROUDLY ASSEMBLED IN THE U.S.A .
Table of Contents
SECTION 1: INTRODUCTION .............................................................................................................................................. 6
INTENDED USE .......................................................................................................................................................................... 6
SYMBOLS REFERENCE ................................................................................................................................................................. 7
Information/Safety Symbols ............................................................................................................................................. 7
Device Symbols ................................................................................................................................................................. 8
SPECIFICATIONS ......................................................................................................................................................................... 9
CONTRAINDICATIONS ............................................................................................................................................................... 10
INDICATIONS FOR USE .............................................................................................................................................................. 11
DYNAMIC NETWORK ANA LYSIS ................................................................................................................................................... 12
SECTION 2: SAFETY GUIDELINES ...................................................................................................................................... 13
DEVICE SAFETY GUIDELINES ....................................................................................................................................................... 13
PATIENT SAFETY GUIDELINES ..................................................................................................................................................... 14
BATTERY AND POWER SUPPLY SAFET Y GUIDELINES ........................................................................................................................ 16
SECTION 3: PRODUCT DESCRIPTION ................................................................................................................................ 18
DEVICE AND ACCESSORIES ......................................................................................................................................................... 18
FEATURE IDENTIFICATION .......................................................................................................................................................... 19
UNDERSTANDING THE CONTROL PANEL ....................................................................................................................................... 20
SECTION 4: OPERATING INSTRUCTIONS .......................................................................................................................... 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 AND ALARMS .......................................................................................................................... 30
ALARM AND ALERT SCREEN DESCRIPTIONS ................................................................................................................................... 31
ACCESSING THE ALARM SYSTEM TEST .......................................................................................................................................... 35
SECTION 6: MAINTENANCE AND CLEANING .................................................................................................................... 37
MAINTENANCE........................................................................................................................................................................ 37
PRE-USE FUNCTIONAL CHECK .................................................................................................................................................... 37
DEVICE CARE AND CLEANING ..................................................................................................................................................... 37
Cleaning .......................................................................................................................................................................... 37
Disinfection ..................................................................................................................................................................... 37
AC AND DC POWER SUPPLIES AND CORDS ................................................................................................................................... 38
AIR INLET FILTER CLEANING ....................................................................................................................................................... 39
CARRY BAG CLEANING .............................................................................................................................................................. 40
CANNULA CLEANING ................................................................................................................................................................ 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
Section 1: Introduction
PLEASE READ THIS USER MANUAL CAREFULLY BEFORE USING THIS DEVICE. BE AWARE OF ALL WARNINGS AND SAFETY INFORMATION. ONLY USE ACCESSORIES APPROVED BY O2 CONCEPTS® AND REFERENCED WITHIN THIS MANUAL.
IF YOU DO NOT FULLY UNDERSTAND ALL THE WARNINGS, 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. 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.
.
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 cannula. The Oxlife Freedom detects a patient’s breath and delivers a bolus of oxygen during the inhalation period.
The Oxlife Freedom can be set to deliver flowrates in Settings 1-5. The device has standard power options including a 100-240V AC Power Supply, 10-15V DC Power
Supply and a rechargeable lithium ion battery.
User Profile
The Oxlife Freedom is suitable for adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stages of cancer or any patient requiring supplemental oxygen.
6
Symbols Reference
ICON
MEANING
ICON
MEANING
Warning represents the possibility
patient
Not suitable for use in the anesthetic mixtu re
Information/Safety Symbols
Caution represents the possibility of damage to the equipment
No smoking while using or near device
No open flames
Indoor use only
Do not disassemble
Refer to instructio ns
Type BF equipment
Recycle battery
Drip proof equipment
Alternating current
of harm to the operator or
presence of a flammable
Do not incinerate b a ttery
Use no grease or oils
Do not dispose of in household waste
Keep dry in transpo rt and storage
Class II equipment
Prescription only
Manufacturer
Direct current
7
ICON
MEANING
ICON
MEANING
Device Symbols
Power button
Menu button
Increase flow setting
Decrease flow setting
Battery life indication
AC/DC charging indicator
Cell signal strength
Exit
Airplane mode
Cell connected
GPS signal
RDM connected (Tech Support Only)
RDM mode (Tech Support Only)
Alarm
Breath detection
Device status
AC/DC power
Contains Dynamic Network Analysis® (DNA) technology
8
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)
Inspiratory Trigger Sensitivity
≤ 0.2 cm H2O
Battery Specification
14.4V Lithium Ion Battery
External Power Su p p l y Po wer
AC power: 100 - 240V AC, 50/60 Hz @ 1.0-2.0 amps Altitude
0-13,123ft or (0-4000m)
Oxygen Purity
91% ± 4% (87 – 95%) on all settings; measured purity values are within ± 2% of actual
Operating Temper ature
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 (-20°C) to 140°F (60°C)
Transport/ Storage Humidity
0 – 95% non-condensing
Cannula Specification
DO NOT use cannula tubing longer than 7ft (2.13m)
Sound Level (Sound Pressure)
56dBA (on setting 5)
Alarm Sound Level
All alarms triggered by the device will be 48dBA or higher at 1 meter from the unit.
Maximum Outlet Pressure
Less than 137kPa (normal or single fault)
Warranty
Device: 3 years/Sieve Tubes: 1year/Accessories: 1 year
Specifications
Input
DC power: 12-15V DC; Recommended: 15A outlet at 12V
values; there is no variation in purity within the operating altitude. This applies to the full range of environmental operating conditions.
9
Contraindications
Under certain circumstances, the use of non-prescribed oxygen therapy can be hazardous. This
device should only be used when prescribed by a physician.
Not for use in the presence of aerosol sprays or flammable anesthetics.
Additional monitoring may be required for patients using this device who are unable to hear or
see alarms or communicate discomfort. 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.
The availability 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 manufacturer recommendations.
This device is for adult use only. It is not qualified for use by pediatric patients.
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.
10
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.
11
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.
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 listed on page 42 within the section entitled: Accessing the Airplane Mode Screen.
12
Section 2: Safety Guidelines
Device Safety Guidelines
AVOID EXPOSURE TO OPEN FLAMES OR CREATION OF ANY SPARK NEAR YOUR OXLIFE FREEDOM. THIS
INCLUDES SPARKS FROM STATIC ELECTRICITY CREATED BY ANY TYPE OF FRICTION. PROTECT ELECTRICAL POWER CORDS FROM SHARP EDGES TO AVOID ELECTRICAL SHOCK AND SERIOUS PHYSICAL INJURY.
Locate the Oxlife Freedom in a well-ventilated area to allow for adequate air intake. Avoid the
intake of airborne pollutants, smoke or fumes that may impair device performance.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation.
Always use the manufacturer supplied carry bag when ambulating with the device to prevent
device damage.
Use only approved accessories as specified in this User Manual. Use of non-approved accessories
may cause serious damage to the device and will void the warranty.
Locate oxygen tubing and power cords 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
may damage your device and/or batteries.
DO NOT ship the Oxlife Freedom with the batteries installed. Batteries must be shipped separately
and packaged appropriately to avoid damage.
Keep the device away from potential household pests to avoid infestation that will impair device
performance.
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.
DO NOT modify the device. Any modifications made to the device may impair performance or
damage equipment and will void the warranty.
13
Patient Safety Guidelines
DO NOT SMOKE WHILE USING THIS DEVICE. KEEP ALL MATCHES, LIT CIGARETTES, CANDLES, OR ANY
SOURCE OF IGNITION AT LEAST TEN (10) FEET (1.6m) FROM THE DEVICE. THIS DEVICE PRODUCES ENRICHED OXYGEN GAS WHICH ACCELERATES COMBUSTION.
Keep cannula tubing away from children and pets to avoid dan2ger of choking or strangulation. DO NOT remove any small parts or fasteners from device. Small parts can cause injury if inhaled or
swallowed.
DO NOT use the device with a damaged power cord or plug to avoid injury. 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.
DO NOT come in contact with the device when wet to avoid serious injury or the chance of shock. DO NOT use oil, grease or petroleum-based products on or near the device to prevent accidental
ignition.
There is a risk of fire associated with oxygen enrichment during oxygen therapy. Do not use the
oxygen concentrator or accessories near sparks or open flames.
Open flames during oxygen therapy are dangerous and are likely to result in fire or death. DO NOT
allow open flames within ten (10) feet (1.6 m) 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 IS DANGEROUS and is likely to result in facial burns or death.
DO NOT allow smoking within the same room where the oxygen concentrator or any oxygen carrying accessories are located. If you intend to smoke, you must always turn the oxygen concentrator off, remove the cannula and leave the room where the oxygen concentrator is located. If you are unable to leave the room, you must wait at least 10 minutes after you have turned the oxygen concentrator off before smoking.
To ensure you are receiving the therapeutic amount of oxygen according to your medical
condition, the Oxlife Freedom must be used only after one or more settings have been individually determined or prescribed by a physician for you at your specific activity levels. The Oxlife 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. DO NOT use petrole um or oi l -based lotions or salves to avoid the risk of fire and burns.
DO NOT lubricate fittings, connections, tubing or other accessories to avoid the risk of fire and
burns.
14
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.
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.
15
Loading...
+ 35 hidden pages