USER MANUAL - O2 Concepts

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. DEALER: THIS MANUAL MUST BE GIVEN TO THE END user . Oxlife INDEPEND ENCE user MANUAL PROUDLY MADE IN THE PLEASE READ THIS OPERATION 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, AND OPERATING INSTRUCTIONS CONTACT YOUR AUTHORIZED DEALER OR PROVIDER FOR TECHNICAL SUPPORT. CAUTION: FEDERAL LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. 6 Table of Contents Table of Contents Section 1: Introduction .. 9 Symbols Reference .. 9 How to Contact O2 Concepts .. 11 Specifications .. 12 Indications for Use .. 14 Dynamic Network Analysis .. 15 Section 2: Safety 16 Device Safety Guidelines .. 16 Battery and Power Supply Safety Guidelines.

2 18 Section 3: Product Description .. 19 Device and Accessories .. 19 Feature Identification .. 20 Understanding the Control Panel .. 21 Applied Parts .. 22 Section 4: Operating Instructions .. 23 Before Operating .. 23 Locating Your Device .. 24 Device Settings .. 25 Pulse Mode Bolus Volumes .. 26 Installing and Removing the Battery .. 27 Typical Battery Operation Times .. 27 Battery Time Management .. 28 7 AC Power Supply Home .. 29 DC Power Supply Auto .. 30 DC Power Supply Information Guide for Use .. 31 DC Power Supply Troubleshooting Guide for Use 32 Handling .. 34 Accessory Bag .. 35 Cannula Use .. 36 Humidifier Kit .. 37 FiresafeTM Cannula Valve .. 38 Entering and Exiting Airplane Mode .. 40 Accessing the Provider Screen and Changing Languages .. 42 Section 5: user Alerts and Alarms .. 45 Alarm and Alert Screens .. 45 Alarm System Test .. 46 How to Simulate Alarms and Alerts (Providers Only) .. 50 How to Respond to Alarms .. 54 Section 6: Maintenance and Cleaning .. 58 Maintenance.

3 58 user Care and Cleaning .. 58 Air Inlet Filter Cleaning .. 58 Battery Disposal .. 60 Device Disposal .. 60 Section 7: Standards Compliance .. 61 8 NOTES .. 62 9 Section 1: Introduction Symbols Reference Icon Meaning Icon Meaning On/Off Button Use no grease or oils Mode Button Type BF Equipment Continuous Mode Do not dispose of in household waste Pulse Mode Keep dry in transport and storage Breath Detect Icon Not suitable for use in the presence of a flammable anesthetic mixture Increase Flow Setting No smoking while using or near device Decrease Flow Setting No open flames Battery Life Indication Date of Manufacture AC/DC Power Caution (as seen in MANUAL ) AC/DC Charging Indicator Warning (as seen in MANUAL ) 10 Icon Meaning Icon Meaning Do not disassemble Auto (as seen in MANUAL ) Home (as seen in MANUAL ) The Oxlife Independence protects against solid objects over 12mm and direct sprays of water up to 15 of vertical (IEC 60529) Refer to instructions Contains Dynamic Network Analysis (DNA)

4 Technology Class II Equipment 11 How to Contact O2 Concepts Please contact your homecare provider if your Oxlife Independence requires service. Please call O2 Concepts Technical Support, at 1-(877)-867-4008, for support with your Oxlife Independence. Please call Customer Service to report any unexpected operation and events associated with the device. Information about the Oxlife Independence and O2 Concepts can also be found on our website at 12 Specifications DIMENSIONS Device Dimensions with Handle/Wheels H: in H: cm W: in W: cm D: in D: 24 cm WEIGHTS Device Weight lbs. ( kg) Cart Kit (Wheels & Pull Handle) lbs. ( kg) Battery lbs. ( kg) AC Charger lbs. ( kg) DC Charger .37 lbs. ( kg) MODES OF OPERATION Continuous Flow to 3 LPM in LPM increments; Measured flow values are within 2% of actual values. Max flow LPM. Flow maintained with outlet pressure ranging from 0 to psig (0-34kPa) Pulse Dose to (8mL-96mL) setting increments; Measured flow values are within 2% of actual values Battery Specification Lithium Ion Battery External Power Supply Power Input AC power: 100 - 240 VAC, 50/60 Hz @ amps DC power: 12-15 VDC; Recommended: 15A outlet at 12V Altitude 0-13,123ft or (0-4000m) Oxygen Purity 91% 4% (87 - 95%) from to LPM; Measured purity values are within 2% of actual values; There is no variation in purity within the operating altitude.

5 Operating Temperature 50 F (10 C) to 104 F (40 C) Operating Humidity 10% - 95% @ F (28 C) Operating Atmospheric Pressure 101kPa to 63kPa Operating Environment Free of smoke, pollutants, and fumes. Transport/ Storage Temperature -4 F (-20 C) to 140 F (60 C) Transport/ Storage Humidity 0 -95% non-condensing Operating Time 24 hours per day when connected to an external AC or DC power source. This is a continuous operation device. Cannula Specification DO NOT use cannula tubing longer than 7ft ( ) when using Pulse Flow Mode Do NOT use cannula tubing longer than 50ft ( ) when using Continuous Flow Mode. A-Weighted Sound Pressure Level The volume that the device will reach at maximum settings will be ~ 56dBA with maximum peaks of Alarm Sound Level All alarms triggered by the device will be 85dBA at 10cm from the unit. Maximum Outlet Pressure Device will maintain flow up to 5psi back pressure. Maximum back pressure is Service Life Device: 5yrs, Accessories: 1yr 13 Contraindications Under certain circumstances, the use of non-prescribed oxygen therapy can be hazardous.

6 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. The Oxlife Independence is not appropriate for any patient who would experience adverse health consequences as a 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. This device is for adult use only. It is not qualified for use by pediatric patients. 14 Indications for Use PRESCRIBED MODE AND FLOW SETTINGS SHOULD ONLY BE ADJUSTED UNDER THE ADVICE OF A PHYSICIAN The O2 Concepts Oxlife Independence 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.

7 Federal law restricts this device to sale by or on the order of a physician. No modification of this equipment is allowed. There is no know interference posed by ME equipment during specific investigations or treatments. There are no known devices that will cause interference issues. 15 Dynamic Network Analysis This version of the Oxlife Independence contains Dynamic Network Analysis (DNA) technology that allows your health care provider to better serve your needs. This technology will allow your provider to ensure that your device continues to operate within specification. The cell must be deactivated prior to flight on a commercial aircraft. Instructions for deactivating the cell are listed on page 39 and 40 within the Section: Entering and Exiting Airplane Mode. Device is FAA approved for use aboard passenger aircraft (FAA Advisory Circular ), including radio frequency emission limits of (RTCA) Document (DO) 160. section 21. Category M. Device contains FCC Id R5Q-LISAC200A.

8 16 Section 2: Safety Guidelines Device Safety Guidelines Avoid exposure to open flames or creation of any spark near your Oxlife Independence. 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 Independence in a well ventilated area to allow for adequate air intake. Avoid the intake of airborne pollutants, smoke, or fumes. 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. DO NOT block the air inlet or the exhaust vents located on the side of the device. DO NOT cover the device with a towel, blanket, etc. DO NOT drop or insert any objects or liquid into any opening.

9 DO NOT leave your Oxlife Independence or batteries in your vehicle or trunk. Extreme hot or cold may damage your device and or batteries. DO NOT ship the Oxlife Independence with the batteries installed. Batteries must be shipped separately and packaged appropriately. 17 Device Safety Guidelines DO NOT SMOKE WHILE USING THIS DEVICE. KEEP ALL MATCHES, LIT CIGARETTES, CANDLES, OR OTHER SOURCES OF IGNITION AT LEAST 10 FEET FROM THE DEVICE. THIS DEVICE PRODUCES ENRICHED OXYGEN GAS WHICH ACCELERATES COMBUSTION. Outdoor use must be conducted using battery power. Keep unit away from children, pets, and potential house hold pests. Use caution when operating with long power cords or cannulas due to possibility of strangulation from excess length. Use caution as small parts may pose a choking hazard. Do not remove any parts or fasteners from unit. Small parts can cause injury if inhaled or swallowed. DO NOT use the device with a damaged power cord or plug. DO NOT operate the device on wet surfaces or in standing water, and do not submerge or expose to water.

10 If the Oxlife Independence has been dropped, damaged or exposed to water please contact your authorized dealer for inspection and possible repair of the device. DO NOT come in contact with the device when wet. DO NOT use oil, grease, or petroleum based products on or near the device. DO NOT use the device with an extension cord. 18 Battery and Power Supply Safety Guidelines Use of non-approved battery or power supply may cause serious damage to the device and will void the warranty. Store the battery in a cool dry place when not in use. Remove the battery from the device if it will not be used for an extended period of time. Locate the external power supply in the open air to prevent overheating when in use. Department of Transportation (DOT) and United Nations (UN) regulations require that batteries 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. Use only the supplied battery, AC and/or DC power supplies that were provided with the device.