Oxygen Concentrator Store: Oxygen Suppliers for Oxygen Equipment
User Manual for OxyHome models including: 1400-5100 OxyHome 5L Stationary Oxygen Concentrator, 1400-5100, OxyHome 5L Stationary Oxygen Concentrator, Stationary Oxygen Concentrator, Oxygen Concentrator, Concentrator
OxyHome 5L Stationary Oxygen Concentrator: 1400-5100
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DocumentDocumentOXYGEN CONCENTRATOR User Manual Model: 1400-5100 Rx Only Caution: Federal law restricts this device to sale by or on the order of a physician. Read this instruction manual carefully before use. 1-877-774-9271 | www.oxygenconcentratorstore.com American Medical Sales and Rentals 15055 E. Hinsdale Drive, Bldg D Centennial, CO 80112 Phone: +1 (877) 774-9271 www.oxygenconcentratorstore.com E-mail: sales@amsrco.com 1-877-774-9271 | www.oxygenconcentratorstore.com Contents Glossary - Explanation of Packaging and Labelling Symbols.............................................................................3 Introduction ...............................................................................................................................................................4 About OxyHome ....................................................................................................................................................4 General Information ..............................................................................................................................................4 How to Use this Manual........................................................................................................................................4 Intended Use..........................................................................................................................................................4 Contraindications and Precautions ....................................................................................................................4 Warnings Overview ..................................................................................................................................................5 Cautions Overview ...................................................................................................................................................6 Concentrator Features .............................................................................................................................................7 Front and Back of Concentrator ..........................................................................................................................7 Side Panel ..............................................................................................................................................................7 Control Panel.........................................................................................................................................................8 User Controls.....................................................................................................................................................8 User Interfaces...................................................................................................................................................8 Indicator Lights..................................................................................................................................................8 Flow Meter ..........................................................................................................................................................9 Oxygen Outlet Port............................................................................................................................................9 Accessories ...........................................................................................................................................................9 Operating Instructions .......................................................................................................................................... 10 General Instructions .......................................................................................................................................... 10 Cleaning, Care, and Maintenance ........................................................................................................................ 11 Routine Maintenance and Repairs ................................................................................................................... 11 Case Cleaning .................................................................................................................................................... 11 Cannula Replacement ....................................................................................................................................... 11 Filter Replacement ............................................................................................................................................. 11 Disposal of Equipment and Accessories ........................................................................................................ 11 Troubleshooting .................................................................................................................................................... 12 Product Specifications.......................................................................................................................................... 12 Environmental .................................................................................................................................................... 13 EMC Information .................................................................................................................................................... 13 TERMS AND CONDITIONS.................................................................................................................................... 17 Trademarks and Disclaimer .............................................................................................................................. 18 Trademark ....................................................................................................................................................... 18 Disclaimer ....................................................................................................................................................... 18 This Document................................................................................................................................................ 18 For Help ........................................................................................................................................................... 18 2 1-877-774-9271 | www.oxygenconcentratorstore.com Glossary - Explanation of Packaging and Labelling Symbols | On (Power) Off (Power) Refer to instruction manual/booklet Class II Device symbol WARNING - Statements that describe serious adverse reactions and potential safety hazards. Serial Number CAUTION - Statements that call attention to special care to be exercised by the practitioner/patient. Operating atmospheric pressure Batch code Humidity limitation No Open Flames No Smoking Type BF according to electrical safety requirements No open flame when device is in use or do not incinerate No smoking Do not disassemble (Contact your provider) DO NOT use oil or grease Handle with care Storage temperature U.S. federal law restricts this device to sale by or on the order of a physician Keep dry This side up Stacking limit by number Date of manufacture Do not use if packaging is damaged Separate collection for electrical and electronic equipment Manufacturer 3 1-877-774-9271 | www.oxygenconcentratorstore.com Introduction The OxyHome Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. Please refer to this manual for detailed instructions on warnings, cautions, specifications, and additional information. About OxyHome The OxyHome Oxygen Concentrator uses a pressure swing adsorption process and a molecular sieve to separate and concentrate oxygen from the air. The device can provide a continuous flow of oxygen up to 5 LPM. The concentration of supplied oxygen is from 93% + or 3%. The weight of the OxyHome Oxygen Concentrator is 41.8lbs (19kg). General Information This equipment is classified as: · Class II · Type BF IMPORTANT: Users should read this entire manual before operating the OxyHome Oxygen Concentrator. Failure to do so could result in personal injury and/or death. If you have questions about the information in this user manual or about the safe operation of this system, contact your oxygen provider. How to Use this Manual This user manual contains warnings, cautions, and notes to help call attention to the most important safety and operational aspects of the device. To help identify these items when they occur in the text, they are shown using the following typographical conventions: WARNING: Statements that describe serious adverse reactions and potential safety hazards. CAUTION: Statements that call attention to information regarding any special care to be exercised by the practitioner and/ or patient for the safe and effective use of the device. IMPORTANT: Statements calling attention to additional significant information about the device or a procedure. The Medical Devices Directive 93/42/EEC states that the product provider must ensure that all users of the device are provided with the User Manual. The User Manual for this device has been written to account for training and knowledge of the patient population to operate the device appropriately. Intended Use The OxyHome Oxygen Concentrator is for use by prescription only and intended to deliver concentrated oxygen to adult patients with chronic pulmonary diseases, or any patient requiring supplemental oxygen. The OxyHome Oxygen Concentrator may be used in a home environment or institutional environment. OxyHome is not intended to be life-supporting or life-sustaining. Contraindications and Precautions The OxyHome Oxygen Concentrator is not intended to be used: · In life-supporting or life-sustaining situations · In an operating or surgical environment · With a non-adult population · In conjunction with the flammable anesthetic or flammable materials 4 1-877-774-9271 | www.oxygenconcentratorstore.com Warnings Overview 1. Do not use the product without first reading the user manual. 2. Do not operate this device if unsure of its operation or function. Contact your home oxygen provider for assistance or further information. 3. There is a risk of fire associated with oxygen equipment and therapy. Do not use near sparks or open flames. 4. Geriatrics or any other patient unable to communicate discomfort can require additional monitoring to avoid harm. 5. Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to result in facial burns, serious injury or death of the patient and others from fire. Do not allow smoking or open flames within the same room as the oxygen concentrator or any oxygen carrying accessories. If you smoke, you must always turn the oxygen concentrator off, remove the cannula and leave the room where either the cannula or the concentrator is located. 6. Use only water-based lotions that are oxygen compatible, before and during oxygen therapy. Never use petroleum or oil-based lotions or salves when operating the device to avoid the risk of fire and burns. 7. Open flames during oxygen therapy are dangerous and are likely to result in fire or death. Do not allow open flames within 3 meters (10 feet) of the oxygen concentrator or any oxygen carrying accessory. 8. Oxygen makes it easier for a fire to start and spread. Do not leave the nasal cannula on bed coverings, chair cushions or otherwise unattended with the concentrator on, but not in use; the oxygen will make the materials flammable. Turn the concentrator off when not in use to prevent oxygen enrichment. 9. Explosion hazard. Do not use in the presence of flammable anesthetics, cleaning agents, or other chemical vapors. 10. Do not use this device in the presence of pollutants or fumes. 11. Do not submerge this device in liquid. Do not expose to water or precipitation. Do not expose to dusty conditions. 12. Do not use a device or any accessory that shows any sign of damage. 13. Do not use lubricants on this device or any of its accessories. 14. Use of this device at an altitude above 10,000 feet (3,000 m), or outside the temperature range of 41°F (5° C) to 104°F (40°C), or outside the humidity range of 5% to 95% may adversely affect the flowrate and percentage of oxygen and consequently the quality of therapy. When not in use, the device should be stored in a clean, dry environment between -13°F and 158°F (-25°C and 70°C). Use and/or storage outside of the valid conditions may damage the product. 15. If feeling ill or are experiencing discomfort while using this device, contact your clinician or seek medical assistance immediately to avoid harm. 16. Your home oxygen provider must verify the compatibility of the device and all accessories used prior to use. To ensure you are receiving the therapeutic amount of oxygen for your medical condition, the device and accessories must only be used after one of more settings have been determined or prescribed for you at your specific activity levels by a healthcare professional. 17. The electrical cord and tubing could present a tripping or strangulation hazard. Keep away from children and pets. 18. Do not disassemble or modify this device or any of its accessories. Do not attempt any maintenance other than tasks described in the Troubleshooting section. Disassembly can create an electric shock hazard and will void the warranty. Contact your distributor for servicing by authorized personnel. 19. Use only spare parts recommended by the manufacturer to ensure proper function and to avoid the risk of fire and burns. 20. Do not repair or perform service work while the device is in use by the patient. 5 1-877-774-9271 | www.oxygenconcentratorstore.com Cautions Overview 1. Keep away from heat sources (fireplaces, radiant heaters, etc.) that could cause the operating temperature at or near the device to exceed 104°F (40°C). 2. The display may be difficult to read under bright lighting conditions (sunlight, interior lights, etc.), move away from direct light for viewing the display. 3. Keep away from lint or other loose material that could block the air intake vents. 4. Some countries restrict this device to be sold by or on an order of a prescribing clinician. Please ensure you comply with relevant local laws. 5. Non-prescribed oxygen therapy can be hazardous under certain circumstances. Use this device only when prescribed by a duly licensed clinician. 6. Always operate the device at the flow rate prescribed by a clinician. Do not alter the flow rate unless prescribed by a clinician. Periodic reassessment of the flow settings should be done by a clinician. 7. It is recommended for an alternate source of oxygen to be made available in the event of power outage or mechanical failure. Consult your home oxygen provider or clinician for an appropriate backup system. 8. It is the responsibility of the patient to make alternative or back up arrangements for oxygen when traveling. 9. This device may not reach specified oxygen concentration purity until it has been in use for up to 2 minutes at set flowrate. 10. This device is designed for use by one patient at a time. 11. The device can be re-used by a new patient. The device should be cleaned as indicated in this user manual and, according to local laws and prescriptions prior to delivering to a new patient. 12. If you are unable to hear or see alarms or cannot communicate discomfort, consult a clinician before using this device. 13. If oxygen concentration drops below the specified level, an alarm will indicate this condition. If alarm persists, stop using this device, switch to an alternate source of oxygen, and contact your home oxygen provider. 14. Only use approved accessories with this device. Using unapproved accessories may impair the performance of this device. 15. Always follow the cannula manufacturer's instructions for proper use. 16. Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. 17. Do not use cleaning agents other than those specified in this manual. Allow the cleaning solution to dry from the cleaned surface before use. 18. Always turn off this device when not in use. 19. Do not use extension cords with power cord provided. 20. Always disconnect power and turn off this device before cleaning, see "Cleaning, Care, and Maintenance." 21. Do not obstruct air intake or exhaust vents when operating this device. Blockage can cause buildup of internal heat and shut down or damage this device. 22. Do not place objects on top of this device. 23. Keep away from children and pets to prevent damage to the device and accessories and/ or inadvertent setting changes. 24. Keep the device away from pets and pests. 25. Do not use in dusty or wet conditions. 26. Always use in a well-ventilated location. 27. If this device indicates an abnormal condition, see the Troubleshooting section. 28. Use caution when touching this device in high ambient temperatures. 29. The device can be isolated from power by disconnecting the power supply from the input connector. 6 1-877-774-9271 | www.oxygenconcentratorstore.com Concentrator Features Front and Back of Concentrator Display Oxygen Outlet Port Flow Setting Knob Humidifier Bottle Flow Meter Pause Button Alarm On/Off Timer Switch On/Off Side Panel Oxygen Outlet Port Circuit Breaker Side Handle Top Handle Built-in Filter Box Cabinet Universal Wheels 7 1-877-774-9271 | www.oxygenconcentratorstore.com Control Panel 6 5 4 1 User Controls 3 2 Item 1 2 Description On / Off Switch Timer 3 Alarm On / Off 4 Pause Button User Interfaces Function Press the switch to turn the device "On" or "Off" After the device starts to deliver the oxygen, you can set the treatment time by pressing and holding the Timer button for 10 seconds. You can set the timer from 10 minutes to 300 minutes in 10-minute increments. After the timer setting expires, oxygen delivery will be shutdown automatically. Press and hold this button for 10s to mute alarm sounds. Press the button to pause oxygen delivery. Item Description 5 Display 6 Indicator Lights 7 Audible Signals Function The LCD panel displays total running time, timer, and alarm indicators. Alarm indicators will appear when there is an error. There are four indicator lights on the device, see table below for descriptions. An audible signal (beep) indicates either a change in operating status or a condition that may need response (alert). Indicator Lights There are 4 indicator lights on the device, please see below for descriptions. 1. Low outlet pressure indicator (Low Pressure): Outlet pressure is less than 2.2 psi, the indicator light will flash yellow every two seconds and an alarm will sound. 2. Low oxygen purity indicator (Low Conc.): If the oxygen concentration drops below 82% (V/V) the indicator light will flash yellow, and the alarm will sound. 3. Power loss indicator (Power Outage): When there is a power outage, the indicator light will flash yellow every 2 seconds and the alarm will sound. 4. Power status indicator: When the concentrator is powered on, the indicator light will remain solid green if the concentrator is working normally. Low Pressure 8 1-877-774-9271 | www.oxygenconcentratorstore.com Item No. Alarm type Alarm Signals / Indicator light Priority Color Flashing frequency Vacancy ratio Auditory Yes/No Alarm condition delay/ s Alarm signal generation delay/s Power supply failure Flashing 1 alarm Med Yellow every two 50% Yes 5s 5s seconds Flashing 2 Start-up fail alarm Med Yellow every two seconds 50% Yes 5s 5s Low oxygen concentration Flashing 3 ALARM (non-startup) Med Yellow every two 50% Yes 5 s 5s seconds Flashing 4 Pressure failure alarm Med Yellow every two 50% Yes 5 s 5s seconds Flow Meter WARNING: Always operate the device at the flow rate prescribed by your physician or therapist. Do not change the L/min setting on the flowmeter unless a change has been prescribed. Rotate the knob on top of the flow meter to set the flow as prescribed by your physician or doctor. The position of the black ball inside of the flow meter indicates the flow rate. Oxygen Outlet Port Connection port for cannula or humidifier bottle. Accessories CAUTION: Only use approved accessories with this device. The accessories listed below are recommended for use with this device. The use of any other accessories which are not specified for use with this device may reduce performance and void the manufacturer's warranty. Contact your distributor for updated information and accessories or if additional, optional, or replacement accessories are needed. Description User Manual Cabinet Filter Compressor Inlet Filter HEPA Filter Locking Wheel Flow Control Knob Part Number 1170-5400 1170-5401 1170-5402 1170-5403 1170-5404 1170-5405 9 1-877-774-9271 | www.oxygenconcentratorstore.com Necessary but not provided with this equipment Nasal Cannula There are many types of nasal cannulas that can be used with this device. Any FDA approved nasal cannula tube can be used with continuous flow delivery and may be sized according to your prescription as recommended by your homecare provider who should also give you advice on the proper usage, maintenance, and cleaning. The use of FDA approved nasal cannulas are recommended (Product code: CAT, regulated by CFR 868.5340) The nasal cannula is for single patient use. CAUTION: Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. A nasal cannula must be used with OxyHome to provide oxygen from the concentrator. A humidifier is not included with the device. If you need humidification, please consult with your provider. If you are using a humidifier, connect tubing from the concentrator's oxygen outlet to the humidifier. Then connect the supply tube/cannula to the humidifier. For detailed usage, cleaning and disinfection of the oxygen supply tube and humidifier bottle, please refer to their instruction or use provided by your supplier. Operating Instructions General Instructions WARNING: Do not use the device or any accessory that shows any sign of damage. 1. Place the concentrator in a well-ventilated location. The concentrator requires unobstructed ventilation. Ventilation ports are located at the bottom and back of the concentrator. Place device a minimum of 6 to 12 inches away from walls, furniture, and curtains which may impede air flow to the device. 2. Ensure both particle filters are in place. CAUTION: Do not operate the device without the inlet filter and gross particle filter in place. The concentrator may be damaged if used without these filters. 3. Connect the Power Supply Connect the AC power plug to an electrical outlet. CAUTION: Avoid the use of electrical extension cords with the concentrator. If an extension cord must be used, please consult your Equipment Provider. 4. Connect the nasal cannula tubing to the oxygen outlet port. 5. Power on the concentrator by pushing the On/Off switch to On (|). The power indicator light will turn solid green. 6. Set the concentrator to the flow prescribed by your physician. Rotate the knob on the top of the flow meter to set the flow as prescribed by your physician or doctor. 7. Position the nasal cannula on your face and inhale the oxygen through your nose. Place the nasal cannula over your ears and position the two prongs of the nasal cannula into your nostrils to start oxygen therapy. 8. When not in use, turn off the concentrator by pushing the On/Off button to Off (). 10 1-877-774-9271 | www.oxygenconcentratorstore.com Cleaning, Care, and Maintenance Routine Maintenance and Repairs The service life of the internal filters and sieve modules will depend on operating conditions. Do not attempt to repair the device. Contact your home oxygen provider or distributor for assistance. WARNING: Do not use oil, grease, or petroleum-based products on or near the Oxygen Concentrator or its accessories. CAUTION: Always disconnect power and turn off this device before cleaning. Do not disassemble or modify this device or any of its accessories due to danger of electrical shock. Case Cleaning You may clean the outside case using a cloth dampened with a mild liquid detergent (Such as DawnTM) and water. Clean the exterior with a soft cloth slightly dampened with soapy water or with anti-bacterial wipes (Isopropyl alcohol 70% solution). For disinfecting, use a wipe or equivalent and follow the manufacturer's instructions. Cannula Replacement Your nasal cannula should be replaced on a regular basis. Consult with your physician and/or equipment provider and/or cannula manufacturer's instructions for replacement information. CAUTION: Refer to the original manufacturer's instruction for cleaning the nasal cannula. Filter Replacement The gross particulate filter located on top of the filter box should be cleaned with warm water and mild detergent weekly. Allow filter to dry fully before using. Regular cleaning of the gross particulate filter is essential for the safe operation of the device. The inlet filter located inside the filter box is designed to last up to 2 years depending on the environment. Consult your equipment provider for further instructions on filter replacement. Disposal of Equipment and Accessories Follow your local governing ordinances for disposal and recycling of the OxyHome Oxygen Concentrator and accessories. If WEEE regulations apply, do not dispose of unsorted municipal waste. Within Europe, contact the EU Authorized Representative for disposal instructions. 11 1-877-774-9271 | www.oxygenconcentratorstore.com Troubleshooting If your concentrator fails to operate properly, consult your Equipment Provider, and refer to the troubleshooting chart below for probable causes and solutions. Problem No or low oxygen Probable Cause Internal leak, kinked cannula, or supply tube. Solution Check supply tube and cannula for obstructions. Overheating of the device Operating temperature is Make sure unit is placed in well-ventilated area and too high. ventilation ports are not blocked Condensation in supply tubing and cannula. Ventilation ports are blocked. Environmental temperature is too high. The device is running hot which can cause condensation in the supply tube and cannula. Move unit to a well-ventilated area and keep supply tubing off cold surfaces. Device will not turn on Cooling fan has malfunctioned causing the unit to run hot Consult your Equipment Provider for service. No power to AC outlet Check AC outlet and circuit breaker Alarm Occurs See alarm indicators Check the indicator lights and LCD display for details on the alarm. Call your Equipment Provider for service if necessary. Product Specifications Flow Specifications Oxygen Concentration Oxygen Output Pressure Rated Voltage/Frequency Power Consumption Sound Dimensions Weight 0 LPM - 5 LPM 93% (+3%, -3%) (V/V) 8 (+2, -2) psi 120 VAC ±10% 60Hz 350 watts 45 dB(A) 13.4 in. W x 11.8 in. D x 25.6 in. H (34 cm x 30 cm x 65 cm) 41.8Ibs (19kg) 12 1-877-774-9271 | www.oxygenconcentratorstore.com The permissible environmental conditions for Temperature: -4F to 140F transport and storage: Humidity limitation: up to 80% RH Environmental conditions of transport and storage between uses Temperature: -13F to 158F Humidity limitation: 90% RH Humidity limitation:15%RH to 90% RH Environmental Operational altitude of concentrator: 0-10,000 ft (3,000 m). When operating the device beyond this altitude range, it will cause insufficient oxygen concentration. EMC Information WARNING: Avoid stacking the device on top or below other electronic equipment. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: Use of accessories, transducers, and cables other than those specified or provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic resistance of this device and result in malfunction. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should not be placed closer than 12 inches (30 cm) to any part of the concentrator. Table 1 Guidance and Manufacturer's Declaration: Electromagnetic Emissions 1400-5100 is intended for use in the electromagnetic environment specified below. The customer or the user of 1400-5100 should assure that it is used in such an environment. Emissions test RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions IEC 61000-3-2 Compliance Group1 Class B Class A Electromagnetic environment - Guidance 1 4 0 0 - 5 1 0 0 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. 1400-5100 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/Flicker emissions Complies IEC 61000-3-3 13 1-877-774-9271 | www.oxygenconcentratorstore.com Table 2 Guidance and Manufacturer's Declaration: Electromagnetic Immunity 1400-5100 is intended for use in the electromagnetic environment specified below. The user of 1400-5100 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 ±8kV contact ±8kV contact ±2kV, ±4kV, ±8kV, ±15kVair ±2kv, ±4kV, ±8kV ±15kV air ±2kV for power supply lines ± 1 kV for input/ output lines ± 2kV for power supply lines ±1kV for input/output lines Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 3 0 % . The power supply should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±0.5kV, ±1kV line(s) to lines ±0.5kV, ±1kV, ±2kV line(s) to earth Voltage dips, short 0% UT; 0.5 cycle at 0°, 45°, interruptions and voltage 90°, 1 3 5°, 180°, 225°, 270° variations on power supply and 315° input lines IEC 61000-4-11 0%UT;1cycleand 70% UT; 25/30 cycles Single phase:at0° ±0.5kV, ±1kV line(s) to The power supply should be that of a typical lines commercial or hospital environment. ±0.5kV, ±1kV, ±2kV line(s) to earth 0% UT; 0.5 c y c l e At 0°,45°, 90°,135°, 180°,225°,270°and 315° 0%UT; 1 cycle and 70% UT; 25/30 cycles The power supply should be that of a typical commercial or hospital environment. If the user of the 1400-5100 requires continued operation during a p o w e r o u t a g e , it is recommended that the 1400-5100 be powered from an uninterruptible power supply or a battery 0%UT;250/300 cycles Single phase: at 0 ° 0%UT;250/300 cycles Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 14 1-877-774-9271 | www.oxygenconcentratorstore.com Table 3 Guidance and Manufacturer's Declaration: Electromagnetic Immunity 1400-5100 is intended for use in the electromagnetic environment specified below. The customer or the user of 1400-5100 should assure that it is used in such an environment. Immunity test IEC 60601 Test Level Compliance level Electromagnetic Environment - Guidance Conducted RF 3V 3V IEC 61000-4-6 0.15 MHz to 80 MHz 6 V in ISM a n d amateu radio r 0.15 betwee MHz n and 80 band s M Hz 0.15 MHz to 80 MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz Radiated RF IEC61000-4-3 10V/m 80 MHz to 2.7 GHz 10V/m Portable and mobile RF communications equipment should be used no closer to any part of the device than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 150KHz to 80 MHz 80 M H z to 800MHz 80 MHz t o 2.7 GHz where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each high frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed RF transmitters, such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which 1400-5100 is used exceeds the applicable RF compliance level above, 1400-5100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m. 15 1-877-774-9271 | www.oxygenconcentratorstore.com Table 4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and this Device 1400-5100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of 1400-5100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters)and 1400-5100, as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter (M) (W) 0.15 MHz to 80 MHz 80 MHz to 800 MHz 80MHz to 2.7 GHz d=1.2P d=1.2P d=2.3P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Table 5 Declaration - Immunity to proximity fields from RF wireless communications equipment 1400-5100 is intended for use in an electromagnetic environment in which RF wireless communications equipment are controlled. Immunity test Test frequency IEC60601testlevel Modulation Maximum power Immunity level Compliance Electromagnetic level environment guidance Radiated RF IEC 61000-4-3 385 MHz **Pulse Modulation: 18Hz 450 MHz *FM+ 5Hz deviation:1kHz sine 1.8W 2W 27V/m 28 V/m 27V/m 28 V/m 710 MHz 745 MHz 780 MHz **Pulse Modulation: 217Hz 0.2W 9 V/m 9 V/m 16 1-877-774-9271 | www.oxygenconcentratorstore.com 810 MHz **Pulse 2W 28 V/m 28 V/m 870 MHz Modulation: 18Hz 930 MHz 1720 MHz **Pulse 2W 28 V/m 28 V/m 1845 MHz Modulation: 217Hz 1970 MHz 2450 MHz **Pulse 2W 28 V/m 28 V/m Modulation: 217Hz 5240 MHz 5500 MHz 5785 MHz **Pulse Modulation: 217Hz 0.2W 9 V/m 9 V/m Note *- As an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because while it does not represent actual modulation, it would be worst case. Note**-The carrier shall be modulated using a 50% duty cycle square wave signal. TERMS AND CONDITIONS 1. This warranty is limited to the original purchaser of the unit and is valid for a period of 3 years from the date of purchase. 2. Any defective part or assembly will be repaired or replaced at the sole discretion and determination of supplier, if the unit has been properly operated and used during the warranty period. 3. Repairs or replacements of parts under warranty will be carried out by the company or by our approved service dealers only. 4. Normal maintenance items and disposable components like Cannula, Humidity Bottle, filters etc. are not covered by this warranty. All expenses incurred in shipping or collecting the unit or its parts, to and from the company/approved service dealer shall be paid by the purchaser. 5. This warranty does not apply to damages caused by the user or if the device is tampered with, modified, or if an attempt is made to repair partially/fully by any unauthorized person/party. 6. This warranty will be null and void if the serial number on this product has been altered or removed/or if the purchaser fails to present the filled warranty card/Manual with which the item was purchased initially. 7. This warranty is null and void if the device is used with dirty/occluded filters or water damage to the electronics of the machine due to any type of negligence. 8. The customer is responsible for the supply of adequate stabilizer/UPS and input power for the machine. Any damages caused due to improper power supply voids the warranty. 9. Machine should be run in a clean environment where the dust is minimal. 10.The warranty extended is in lieu of any other express warranties or implied conditions and warranties under the law and is confined to repairs OR replacement of the defective parts only and does not cover any other direct, indirect, or consequential losses, which are expressly disclaimed. Furthermore, this warranty in no case shall extend to payment of any monetary consideration or replacement or return of the product. EXCEPT AS PROVIDED HEREIN, OXYGO HQ FLORIDA, LLC MAKES NO WARRANTY WHATSOEVER WITH RESPECT 17 1-877-774-9271 | www.oxygenconcentratorstore.com TO THE GOODS, INCLUDING ANY (A) WARRANTY OF MERCHANTABILITY OR (B) FITNESS FOR A PARTICULAR PURPOSE, WHETHER EXPRESS OR IMPLIED BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE. Trademarks and Disclaimer Trademark All trademarks are the property of their respective owners. Disclaimer The information in this document has been carefully examined and is believed to be reliable. Furthermore, the manufacturer reserves the right to make changes to any products herein to improve readability, function, or design. The manufacturer does not assume any liability arising out of the application or use of any product or circuit described herein; neither does it cover any license under its patent rights nor the rights of others. This Document The information in this document is subject to change without notice. This document contains proprietary information that is protected by copyright. No part of this document may be reproduced in any manner, in whole or in part (except for brief excerpts in reviews and scientific papers), without the prior written consent of the manufacturer. Be sure to read carefully and understand all manuals provided with the product. For Help If you have questions about the information in these instructions or about the safe operation of this device, contact your home oxygen provider or distributor. To view the most up-to-date version of this manual, please visit our website at www.oxygo.life/oxyhome. Manufactured for: OxyGo HQ Florida, LLC 2200 Principal Row Orlando, FL 32837 United States M544-0623 V15 1170-5400 18 1-877-774-9271 | www.oxygenconcentratorstore.com American Medical Sales and Rentals 15055 E. Hinsdale Drive, Bldg D Centennial, CO 80112 Phone: +1 (877) 774-9271 www.oxygenconcentratorstore.com E-mail: sales@amsrco.com 1-877-774-9271 | www.oxygenconcentratorstore.com