Patient Manual Oxygen Concentrator Includes: Oxygen Monitor, Air Outlet, Dual Flow, and Pediatric Flow Options
DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS, CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTING TO USE THIS EQUIPMEN; OTHER INJURY OR DAMAGE COULD OCCUR. Smoking while using oxygen is the number one cause of fire, injury, and death. You must follow these safety warnings: Do not allow smoking, candles, or open flames within the same room of the device or the oxygen-carrying accessories.
TABLE OF CONTENTS AirSep® NewLife® Elite Oxygen Concentrator AirSep NewLife Elite Oxygen Concentrator 1 Important Safety Rules 1 Why Your Physician Prescribed Oxygen 6 What is an Oxygen Concentrator? 7 How to Operate Your Oxygen Concentrator 8 Filters 12 Oxygen Without Humidifier 12 Oxygen With Humidifier 13 Nasal Cannula 14 Proper Setting of Oxygen Flow meter 15 Cleaning, Care, and Proper Maintenance 16 Cabinet 16 Filters 17 Reserve Oxygen Supply 17
TABLE OF CONTENTS AirSep® NewLife® Elite Oxygen Concentrator Troubleshooting 18 Product Specifications 20 EMC Summary 24 Classification 29 Oxygen Monitor Option 30 Function of the Oxygen Monitor 30 Alarm Signal 30 Operating the NewLife Elite Air Outlet 31 31 Air Outlet Option Dual Flow and Pediatric/ Low Flow Options Symbols/Abbreviations 38 Dual Flow Application 39 Pediatric/Low Flow Application 39 Setting the Pediatric Flow meter 40 41
[Read the Important Safety Rules section before operating this equipment.] AirSep® NewLife® Elite Oxygen Concentrator This Patient Manual will acquaint you with AirSep’s NewLife Elite Oxygen Concentrator. Make sure you read and understand all the information contained in this manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
This device supplies high-concentration oxygen that promotes rapid burning. Do not allow smoking or open flames within the same room of (1) this device, or (2) any oxygen-carrying accessory. Failure to observe this warning can result in severe fire, property damage and / or cause physical injury or death. Do not use your oxygen concentrator in the presence of flammable gases. This can result in rapid burning causing property damage, bodily injuries or death.
Electrical shock hazard. Turn Off the unit and disconnect the power cord from the electric outlet before you clean the unit to prevent accidental electrical shock and burn hazard. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit. Care should be taken to prevent the Oxygen Concentrator from getting wet or allowing fluids to enter the unit. This can cause the unit to malfunction or shut down, and cause an increased risk for electrical shock or burns.
Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider. Do not position the unit so that it is difficult to access the power cord. The concentrator should be located as to avoid smoke, pollutants or fumes. Ensure concentrator is operated in an upright position. Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard. Position the unit away from curtains or drapes, hot air registers or heaters.
In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the troubleshooting section of this manual. If you cannot resolve the problem, consult your Equipment Provider. If the audio alarm is weak or does not sound at all, consult your Equipment Provider immediately For units equipped with the oxygen monitor option - Contact your Equipment Provider immediately if the amber OXYGEN MONITOR light remains on for more than 15 minutes and/or the audio alarm activates.
The Manufacturer does not recommend the sterilization of this equipment. If the unit has not been used for an extended time period, it needs to operate for a minimum of minutes before power failure alarm can become activated. For units equipped with the oxygen monitor option - When you turn the unit on, it’s normal for the amber OXYGEN MONITOR light to turn on and remain on for up to five minutes. For prescriptions levels below 1 lpm, you must operate the oxygen concentrator for at least 5 minutes at 2 lpm.
[Read the Important Safety Rules section before operating this equipment.] Why Your Physician Prescribed Oxygen Many people suffer from a variety of heart, lung, and other respiratory diseases. A significant number of these patients can benefit from supplemental oxygen therapy at home, in the hospital, or at a medical facility. Oxygen is a gas that makes up 21% of the room air we breathe. Our bodies depend on a steady supply to function properly.
[Read the Important Safety Rules section before operating this equipment.] What is an Oxygen Concentrator? Oxygen concentrators were introduced in the mid-1970’s and have become the most convenient, reliable source of supplemental oxygen available today. Oxygen concentrators are the most cost-effective, efficient, and safest alternative to using high-pressure oxygen cylinders or liquid oxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottle deliveries required.
[Read the Important Safety Rules section before operating this equipment.] E F How to Operate Your Oxygen Concentrator First, become familiar with the important parts of your NewLife Elite Oxygen Concentrator (Figures 1a and 1b). A. On/Off (I/0) Power Switch: Starts and stops the operation of the unit. B. Circuit Breaker Reset Button: Resets the unit after electrical overload shutdown C. Digital Hour Meter: Records the unit’s total hours of operation. D.
[Read the Important Safety Rules section before operating this equipment.] I. Air Intake Gross Particle Filter: Prevents dust and other airborne particles from entering the unit. J. Power Cord: Allows connection of unit into electrical outlet. Do not use extension cords with this unit or connect too many plugs into the same outlet. Too many plugs in one outlet can result in an overload to the electrical panel causing the breaker/fuse to activate or fire if the breaker or fuse fails to operate. I J 1.
[Read the Important Safety Rules section before operating this equipment.] 6. Insert power cord into the electrical outlet. On/Off Power Switch 7. Locate the power switch on the front of the unit, and switch it to the I position (on). (Figure 2.) A battery-operated audible alarm must sound for a 5-second test to indicate a good battery and alarm. If the alarm is weak or does not sound at all, consult your Equipment Provider immediately.
[Read the Important Safety Rules section before operating this equipment.] 9. To turn the concentrator off, press the I/0 switch to the 0 position. Ensure concentrator is operated in an upright position For prescriptions levels below 1 lpm, you must operate the NewLife Elite unit for at least 5 minutes at 2 lpm. 10. If the NewLife Elite unit fails to operate properly, refer to the Troubleshooting section for a list of probable causes and solutions.
[Read the Important Safety Rules section before operating this equipment.] Filters Air enters the NewLife Elite unit through an air intake gross particle filter located on the back off the oxygen concentrator. This filter removes dust particles and other large particles from the air. Before you operate the NewLife Elite unit, make sure this filter is clean and positioned correctly (Figure 4).
[Read the Important Safety Rules section before operating this equipment.] Operating With Humidifier Following these steps if your physician prescribed an oxygen humidifier as part of your therapy: 1. Remove or unscrew the reservoir bottle from the humidifier (If you have a pre-filled unit, do not perform this step. Proceed directly to step 4.) 2. Fill the reservoir with cool or cold water (distilled water is preferred) to the fill line indicated on the bottle. DO NOT OVERFILL. 3.
[Read the Important Safety Rules section before operating this equipment.] Nasal Cannula Your physician has prescribed either a nasal cannula, face mask, or other accessories (Figure 8). In most cases the manufacturer has already connected the oxygen supply tubing to the nasal cannula, face mask, or other accessory. If not, follow the manufacturer’s instructions for proper connection. Connect the oxygen tubing to the oxygen outlet adapter or humidifier.
[Read the Important Safety Rules section before operating this equipment.] Proper Setting of Oxygen Flow meter To set the proper flow of supplemental oxygen, turn the flow meter adjustment knob left or right until the ball inside the flow meter centers on the flow line number prescribed by your physician (Figure 9). To view the flow meter at the proper angle, note that the back line and the front numbered line must give the appearance of just one line.
[Read the Important Safety Rules section before operating this equipment.] Cleaning, Care, and Proper Maintenance Cabinet Electrical shock hazard. Disconnect the power cord from the electric outlet before you clean the unit to prevent accidental electrical shock and burn hazard. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit.
[Read the Important Safety Rules section before operating this equipment.] Filters Do not operate the unit without the air intake gross particle filter in place. At least one time each week, wash the air intake gross particle filter, which is located in the back of the unit. Your Equipment Provider may advise you to clean it more often, depending upon your operating conditions. Follow these steps to properly clean the air intake filter: 1.
Troubleshooting If your NewLife Elite Oxygen Concentrator fails to operate properly, refer to the chart on the following pages for possible causes and solutions and, if needed, consult your Equipment Provider. If you cannot get the unit to operate, connect your nasal cannula, face mask, or other accessories to the reserve supplemental oxygen supply (if provided). Do not attempt any maintenance other than the possible solutions listed below. Problem Probable Cause Solution Unit does not operate.
Troubleshooting Continued Problem Probable Cause Solution Condensation collects in the oxygen tubing when you use the humidifier bottle. Unit not properly ventilated. Elevated operating temperature. Make sure unit is positioned away from curtains or drapes, hot air registers, heaters, and fireplaces. Be certain to place the unit so all sides are at least 12 inches (30.5 cm) away from a wall or other obstruction. Do not place the unit in a confined area.
Product Specifications * Based on an atmospheric pressure of 14.7 psi (101 kPa) at 70°F (21°C) ** Operating unit outside of operational temperature range can affect performance. Oxygen Concentration: * ISO 8359: 1.7 IEC 60601-7.9.3 1-3 lpm: 95.5% - 92.0% 4 lpm: 92% ± 3% 5 lpm: 90% ± 3% Physical Characteristics ISO 8359: 1.7 IEC 60601-7.9.2.5 Height: 72.4 cm (28.5 in.) Width: 40.0 cm (15.7 in.) Depth: 36.8 cm (14.5 in.) Weight: 24.5 kg (54.0 lb.) Electrical Power: ISO 8359: 1.8 IEC 60601-4.
Product Specifications Continued O2 Monitor Option ISO 8359: 1.7 IEC 60601-7.9.3 Yellow caution light Range: Below 85% +/- 3% O2 Audible Alarm: After 15 min. +/- 2 min. below specified Range Max Pressure = 60 Psig (414kPa) Max Flow 8 LPM Operating temperature Range: -31°F to 158°F (-35°C to 70°C) Operational Humidity: 0 to 100% Altitude ISO 8359: 1.7 IEC 60601-7.9.3 Sea level to 400 ft. 92%O2 Sound Pressure ISO 8359: 4.6 IEC 60601-1: 9.
Product Specifications Continued Excessive Temperatures** ISO 8359:7.1 IEC 60601-1: 11.1 Maximum O2 Outlet Temperature Rise + 5.4oF (3oC) Flow Rate Range ISO 8359 Section 8_50.3 IEC 60601-1: 7.4 1% maximum difference in flow rate of allowable +/- 10% O2 Concentration at extreme voltage conditions ISO 8359 Section 8_50.4 IEC 60601-1: 7.4 Voltage extreme 132V 103V 253V 195V ISO 8359 Section 8_50.5 Mean O2 Concentration IEC 60601-1: 7.4 ISO 8359 Section 8_50.6 Mean Flow Rate IEC 60601-1: 7.
Product Specifications Continued ISO 8359 Section 8_50.7 Backpressure Effect Test IEC 60601-1: 7.4 Flow 5.00 lpm 4.75 lpm Outlet Pressure Test ISO 8359 Section 8_50.8 IEC 60601-1: 7.4 Actual Pressure 7.3 max psig Applied Pressure * @ 0 psig (0 kPa) @ 1 psig (7 kPa) Max Allowable Limit 8.
EMC SUMMARY: IMMUNITY TEST RESULTS PERFORMANCE CRITERIA Criteria During Test After Test A Operate as intended No Degradation of performance No loss of function Operate as intended No degradation of performance No loss of function B Loss of function (one or more) Operate as intended No degradation of performance Functions self-recoverable C Loss of function (one or more) Operate as intended No degradation of performance Functions recoverable by the operator * Applicable to all life support equipm
EMC SUMMARY: PART I IMMUNITY TEST RESULTS Standard Description Severity Required Performance Criteria Met Performance Criteria Allowed(1) IEC 61000-4-2 EN 61000-4-2 Electrostatic Discharge ±6kV contact ±8kV air A A IEC 61000-4-3 EN61000-4-3 ENV 50204 Radiated RF Immunity 3V/m, 80-1000MHz, 2Hz, 80%AM modulation 3V/m, 1000-2500MHz, 2Hz 80%AM modulation A A IEC 61000-4-4 EN 61000-4-4 Electrical Fast Transient ±2kV on AC ±1kV on I/O A N/A (1) A N/A EN 61000-4-5 EN 61000-4-5 Surge Withstand
EMC SUMMARY: PART I IMMUNITY TEST RESULTS Continued Standard IEC 61000-4-11 EN 61000-4-11 Description Severity Required Performance Criteria Met Performance Criteria Allowed(3) Dips Dips Dips Interrupts < 5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (>95% dip in UT) for 5 seconds * UT: a.c. mains voltage prior to application of the test level.
EMC SUMMARY: PART II EMC EMISSION TEST RESULTS CISPR11: / EN 55011 TEST REQUIREMENTS MARGIN LIMITS BELOW (-) / ABOVE (+) COMPLIANCE (YES / NO) Source Testing: ULTRATECH GROUP OF LABS File #: AIR095-CISPR11B (Elite 120v 60 Hz) 9Aug2010 5.1.2 TABLE 2b, CLASS B (GROUP 1) AC Mains Terminal Disturbance Voltage in the frequency band 150 kHz to 30 MHz -28.1 dB @ 0.152MHz YES 5.2.2 TABLE 3, CLASS B (GROUP 1) Electromagnetic Radiation Disturbance in the frequency band 30 MHz to 1000 MHz -2 dB @ 80.
EMC SUMMARY: PART III FCC EMC EMISSION TEST RESULTS FCC PART 15, SUBPART B TEST REQUIREMENTS MARGIN BELOW (-) / ABOVE (+) THE LIMITS COMPLIANCE (YES / NO) Source Testing: ULTRATECH GROUP OF LABS File #: AIR095-FCC15B (Elite 120V 60Hz) 9Aug2010 15.107(a) , CLASS B AC Power Line Conducted Emissions Measurements -28.3 dB @ 13.007 MHz YES 15.109(a) , CLASS B Radiated Emissions from Unintentional Radiators (Digital Devices) -1.5 dB @ 80.
Classification Type of protection against electric shock: Class II Protection from electric shock is achieved by double insulation. Protective earthing or reliance upon installation conditions are not required. Degree of protection against electric shock: Type BF Equipment providing a particular degree of protection against electric shock particularly regarding: 1) allowable leakage current; 2) reliability of protective earth connection (if present). Not intended for direct cardiac application.
[Read the Important Safety Rules section before operating this equipment.] Oxygen Monitor Option The following information will acquaint you with Oxygen Monitor option of the NewLife Elite Oxygen Concentrator. Make sure you read and understand all the information contained in this manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
[Read the Important Safety Rules section before operating this equipment] Air Outlet Option The following information will acquaint you with the Air Outlet option for the NewLife Elite Oxygen Concentrator. Make sure you read and understand all the information in this NewLife Elite Patient Manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
[Read the Important Safety Rules section before operating this equipment.] The NewLife Elite Air Outlet option allows you to connect a hand held nebulizer Figure 1: Nebulizer with tubing, valve and fitting shown Figure 2: Valve and fitting shown included in Air Outlet Kit P/N KI365-1: • Air Valve AirSep Part No. VA007-1 • Air Outlet Barb Fitting: AirSep Part No. F0032-1 You may continue to receive oxygen from the unit while you use the Air Outlet option. Air Valve Part No.
[Read the Important Safety Rules section before operating this equipment.] 2. Locate the air outlet barb fitting on the front of the unit (Figure 2). If a hand held nebulizer will be used, connect one end of the air supply tubing to the air outlet barb fitting and the other end to the bottom of the nebulizer. Oxygen-enriched air is not delivered at the air outlet. In high humidity environments or during extended period of non-use, open the air valve completely (Figure 3) to purge/flush the system. 3.
[Read the Important Safety Rules section before operating this equipment.] 6. When treatment is complete, turn the air valve to the OFF position. (Figure 4) The NewLife Elite Air Outlet regulator is preset to deliver 6 liters per minute ( lpm) at 12 psig (85 kPa). Figure 4 7. Disconnect the nebulizer and the air supply tubing from the air outlet barb fitting. 8. Clean the nebulizer. (Refer to the Cleaning the Nebulizer section).
[Read the Important Safety Rules section before operating this equipment.] 3. Remove or unscrew the medication cup on the nebulizer, and place your prescribed measured dosage into the medication cup (Figure 5). 4. Connect the medication cup to the nebulizer, and then connect the “T” piece or mouthpiece to the nebulizer (Figure 6). Figure 5 Figure 6 5.
[Read the Important Safety Rules section before operating this equipment.] Inhaling Medication/Treatment Instructions The following instructions for inhaling medication are often recommended. If your physician or health care professional has given you special instructions, make sure you follow them instead, as prescribed. 1. Close your mouth around the mouthpiece, but do not hold it with your teeth (Figure 7). 2.
[Read the Important Safety Rules section before operating this equipment.] Cleaning the Nebulizer Perform steps 1 and 2 below after each treatment to prevent medication from collecting and hardening inside the nebulizer parts. 1. After each treatment, separate the nebulizer and the “T” piece or mouthpiece assembly. 2. Remove or unscrew the nebulizer cup, and rinse each component thoroughly in warm water. 3.
[Read the Important Safety Rules section before operating this equipment.] Dual Flow and Pediatric/Low Flow Options The following information will acquaint you with the 5 liter dual flow and pediatric/low flow options of the NewLife Elite Oxygen Concentrator (see Figure 9). Make sure you read and understand all the information contained in this manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
[Read the Important Safety Rules section before operating this equipment.] Dual Flow Application The NewLife Elite unit’s dual flow option allows a single concentrator to meet the high flow requirements of one patient (Figure 9) or the needs of two patients, in any combination of flows up to the maximum capacity of the concentrator. Excellent for use in the home, extended care facility, hospital, or physician’s waiting room.
[Read the Important Safety Rules section before operating this equipment.] Setting the Pediatric Flow meter When using the pediatric flow meter, the unit will not reach proper concentration at the pediatric setting (less than 2 lpm) until you bleed off a portion of the oxygen by opening the primary flow meter (on the left side of the unit). Follow the procedure below when using the pediatric flow meter. 1. Follow the start-up instructions 1-7 as outlined on page 9 & 10. 2.
Symbols/Abbreviations Symbols are frequently used on equipment and/or the manual in preference to words with the intention of decreasing the possibility of misunderstanding caused by language differences. Symbols can also permit easier comprehension of a concept within a restricted space. The following table is a list of symbols and definitions that may be used with the NewLife Elite Oxygen Concentrator.
Symbol Description Symbol Description Safety agency for CAN/CSA C22.2 No. 601.1 M90 for medical electrical equipment.
For European representative: Medical Product Services GmbH (MPS) Borngasse 20 35619 Braunfels, Germany Tel: +49 (0) 6442-962073 E-mail: info@mps-gmbh.
For service on your NewLife Elite Oxygen Concentrator, please contact your local Equipment Provider at: CAIRE Inc. 2200 Airport Industrial Dr., Ste 500 Ball Ground, GA 30107 www.chartindustries.
