Drive DECO2 User Manual

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Caution: U.S. Federal law

restricts this device to sale by or

on the order of a physician.

Document No.: 5DECO2/5A

OXYGENCONCENTRATOR

USER MANUAL

DO NOT OPERATE THIS UNIT WITHOUT FIRST

READING AND UNDERSTANDING THIS MANUAL!

SAVE THIS MANUAL FOR FUTURE USE.

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Summary of Contents for Drive DECO2

Page 1 Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Document No.: 5DECO2/5A OXYGENCONCENTRATOR USER MANUAL DO NOT OPERATE THIS UNIT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL! SAVE THIS MANUAL FOR FUTURE USE.
Page 2 TABLE OF CONTENTS 1. SAFETY NOTES............4-14 1.1 Important information..........6 1.2 Before installation............6 1.3 Placement..............6 1.4 Fire warning and explosion........7 1.5 Maintenance.............8 1.6 Radio frequency interference......... 8 1.7 MR Unsafe..............9 1.8 Reduce the risk of burns to persons....10 1.9 CAUTION..............
Page 3 TABLE OF CONTENTS 3.7 Alarm signal............28 3.8 Alarm signal cue............ 28 3.9 Turning off.............. 30 3.10 Symbols and descriptions........30 4. MAINTENANCE............32-39 4.1 Cleaning the cabinet..........32 4.2 Cleaning the replacing the filter......32 4.3 Cleaning the optional humidifier bottle....35 4.4 Oxygen nasal cannula...........35 4.5 Tube maintenance..........
Page 4 Do not use the oxygen concentrator or accessories near sparks or open flames. WARNING: To ensure that you receive suitable therapeutic oxygen delivery tailored to your medical condition, the DECO2 Oxygen Concentrator must only be used under the guidance of a physician's order: ●...
Page 5 oxygen and consequently the quality of the therapy. Refer to specifications for details regarding parameters tested. WARNING: Oxygen increases the risk of fire ignition and spreading. Avoid leaving the nasal cannula or mask on bed coverings or chair cushions when the oxygen concentrator is on but not in use, as oxygen can make these materials flammable.
Page 6 Indicates required actions (e.g., “Wear protective gloves”, “Scrub before entering”, etc.). Important Information Electric shock risk DO NOT disassemble. Consult qualified service personnel for any servicing needs. DO NOT modify this equipment without the authorization of the manufacturer. Read the following information before operating the product. Before Installation To prevent damage during transportation, always keep the concentrator in an upright position.
Page 7 clearance of 4 inches (10 centimeters) on all sides, keeping it away from walls, draperies, furniture, or similar surfaces. Avoid placing it near deep-pile carpets, heaters, radiators, or hot air registers. Do not place the device in a confined or small area. The oxygen concentrator MUST be kept away from heat, fire and excessive water sources and conditions.
Page 8 quickly. For safety concerns, it is necessary that all sources of ignition be kept away from the product and preferably out of the room in which it is being used. A spontaneous and violent ignition may occur if oil, grease, or greasy substances contact with pressurized oxygen.
Page 9 The radio frequency (RF) energy emitted by this machine is exclusively intended for the operation of the device itself. Therefore, the RF emissions are minimal and should not disrupt the functioning other nearby electrical equipment, including portable communication devices used in the vicinity of this equipment. MR Unsafe Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to...
Page 10 Use of this equipment adjacent to or stacked with other equipment should be avoided as it may result in improper operation. In case where such use is necessary, it's essential to monitor both this equipment and other relevant devices to ensure that they are functioning normally.
Page 11 point the patient or attendant believes that the patient is not receiving an adequate amount of oxygen, contact the provider and/or physician immediately. No adjustments should be made to the flow rate unless prescribed by a physician. Close supervision is necessary when this product is used near children or individuals with physical challenges.
Page 12 Keep the cord away from HEATED or HOT surface. Do not move or relocate concentrator by pulling on the cord. Do not insert or place any other objects into the openings of the equipment. If you have any problems setting up, maintaining, or using this device, please contact the manufacturer or customer service.
Page 13 that the manufacturer recommends. Do not share the use of the parts, accessories or adapters with other equipment. The parts placement of attachments is critical to the effectiveness of the therapy. Delivery settings of the oxygen concentrator should be periodically reassessed for the effectiveness of the therapy. Geriatric, pediatric or any other patients unable to communicate discomfort can require additional monitoring and/or a distributed alarm system to convey the information about discomfort or the...
Page 14 However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is not required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
Page 15 2、FEATURES Summary Indications for Use: The DECO2 by Drive Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Page 16 sieve beds exchange the role of oxygen concentration and continue to produce 93% oxygen to the patient. This user’s manual will tell you about your concentrator and will serve as a reference as you use your concentrator. Characteristics  Oxygen concentrators consist of a mainframe and a flowmeter.
Page 17 6.Change in maximum recommended flow when back pressure of 7kPa is applied: <0.5 L/min. NOTE: Technical specifications of flowmeter are calibrated by manufacturer and tester. The user should use the device according to the manufacturer's instructions and the doctor's advice. The user is not allowed to adjust the device flow.
Page 18 concentration will remain consistent up to 1828 meters above sea level. However, from 1828 meters to 4000 meters, the efficiency will decrease to less than 90%. 14. Safety System: ① Current overload or line surge shutdown. ② High temperature compressor shutdown. ③...
Page 19 21. Tube: To prevent folding of tube, nasal oxygen is 2 meters, prolonged tube should be no longer than 15.2 meters (no flatting). 22. The Storage and transport Ambient: 1. Temperature Range: 0℃~+55℃ (32℉~+131℉) 2. Relative Humidity Range: 10%~90% 3. Atmospheric pressure: 70kPa~106kPa (10.2psi~15.37psi) NOTE: The oxygen concentrator should be stored in area without erode gas;...
Page 20 3、 INSTALLATION ANDOPERATION Unpacking NOTE: Unless the oxygen concentrator is to be used immediately, it is advised to keep the containers and packing materials for storage until the concentrator is used.  Check for any obvious damage to the carton or its contents. If damage is evident, please notify the carrier or local dealer.
Page 21 Storage Store the repackaged oxygen concentrator in a dry area. DO NOT place anything on top of the repackaged concentrator.
Page 22 FEATURE VIEW Figure 1...
Page 23 -Flow meter Setting oxygen flow rate by adjusting the knob. -Status indicator light -Oxygen tube -Outlet connector 5--Breaker To protect the machine and user, the breaker will cut off power automatically when current ≥ 6A. After cooling, the machine can be turned on if push up the breaker.
Page 24 -Alarm Silence Button used to temporarily silence an audible alarm. When the Oxygen Concentrator has a sound alarm, press the button to turn off the alarm sound. At this time, the button backlight will light up blue. To restore the alarm sound, press the button again, and the button backlight will go off.
Page 25 connect the air outlet of the oxygen concentrator to the air inlet joint of the humidifier bottle. Turn on the oxygen concentrator, then connect the nasal cannula joint to the air outlet of the humidifier bottle. The user can now start the oxygen inhalation process. ●...
Page 26 concentrator’s AC connector into power outlet. 3.5.2 Preparing to connect the humidifier bottle When the user feels uncomfortable inhaling dry oxygen, the humidification bottle can be used to humidify the oxygen. Unscrew the cover of the humidifier, fill the purify water (or distill water) into the humidifier bottle between the maximum and minimum water level lines, and then screw the humidifier bottle.
Page 27 Turning the Concentrator ON ● Press the power switch to the " |" position. At this time, the green and yellow lights are on, the display is lit, indicating that the machine is functioning normally. After about 1 second, only the green light will remain on.
Page 28 Alarm System  Initial startup of the concentrator NOTE: Concentrator may be used during the initial warm-up time (approximately 5 minutes) while waiting for the O concentration to reach its maximum level. When the machine is running normally, the green light will illuminate concentration greater than 82%±2%).
Page 29 6. Low flow alarm: When the oxygen flow rate is lower than 0.5L/min, the yellow light will illuminate, the display screen displays the " " error code, intermittent audible alarm sounds. ("0.4”, the number shows the current oxygen flow data.) 7.High temperature alarm：...
Page 30 Pressure High Low oxygen High Power-off Low flow Start-up abnormal voltage Voltage concentration temperature Alarm alarm alarm fail alarm alarm alarm alarm alarm alarm Alarm category low priority low priority low priority low priority low priority low priority low priority low priority indicator Indicator...
Page 31 Use no oil, Grease or Height Lubricants Date of Serial number manufacture Manufacturer Operation ambient temperature Keep dry Range 5 to 40℃ （+41℉ to 104℉） Atmospheric System Okay, Oxygen Pressure Range 86 to Concentration ≥82% 106 Kpa (Green Light) Alarm Sound ON/OFF LOT Number Button System failure...
Page 32 4、MAINTENANCE DECO2 by Drive recommends using only original equipment manufactured parts and filters in order to guarantee reliable operation of the product. Warning: Power should be disconnected before beginning maintenance on the concentrator. Warning: Do NOT use lubricants, oils or grease.
Page 33 in the following paragraphs in order to protect the compressor and extend the concentrator’s life. DO NOT operate the concentrator without the filters installed, or when filters are wet. These actions could permanently damage the concentrator.  Disassembly Cabinet filte Cabinet filter ...
Page 34 Figure 5 (2) Intake filter  The intake filter access door is located on the left side of the concentrator. Using a small screwdriver, open the access door. Unscrew the block of cabinet filter holder. Remove the intake filter. (Figure 6) ...
Page 35 Cleaning the Optional Humidifier Bottle  Change the water in the humidifier bottle every day.  Cleaning: Wash the humidifier bottle weekly. First, wash the bottle with a solution of mild dish soap (2 tbsp) and warm water (2 cups), then rinse under running water and allow it to dry.
Page 36 4.6 For each new patient DECO2 by Drive recommends that at least the following procedures should be carried out by the manufacturer or a qualified third party when the equipment is transitioned from one patient to another.
Page 37 Use disinfectants safely. Always read the label and product information before use. Always wear personal protective equipment when performing this procedure. Use suitable gloves and safety glasses. Cover exposed skin on the arms to prevent accidental contact with bleach solution applied to the concentrator. Dispose of all accessories that are not suitable for reuse.
Page 38 located on the bottom of the unit. Exposure time of the disinfectant solution should be a minimum of 10 minutes and a maximum of 15 minutes. After the recommended exposure time, all surfaces of the concentrator should be wiped with a clean lint-free cloth dampened with drinking-quality water, ensuring that the water is no warmer than room temperature.
Page 39 In some single fault conditions, such as an internal hose of the device becomes disconnected, there is a risk of the device's patient connection unintentionally becoming contaminated with expired gases. This condition will cause no flow out of the device and/or trigger an alarm.
Page 40 5、TROUBLESHOOTING Troubleshooting Guide Symptom Probable cause Solution Remark Yellow light 1.The power cord is 1. Insert plug into not powered on. outlet. bright, 2. Inspect house intermittent circuit breakers. If audible alarm 2. No power at outlet. problem recurs, use a sounds, the different outlet.
Page 41 4. Fan inside the machine can’t run or 4. Contact Equipment Repairs running rate turns slower Provider immediately. causing the operating qualified temperature too high. personnel 5.Internal repairs 5. Contact Equipment required. Provider immediately. 1.Check flowmeter is 1. Flowmeter set at set at 0.6L/min 0.5L/min or less.
Page 42 6、OTHER ATTENTIVE ITEMS NOTE: If you experience a problem with your concentrator and are unable to service it yourself, contact the equipment provider from whom you purchased the concentrator. GAS PATH OPERATION SKETCH MAP Electrical Diagram...
Page 43 The warranty is 3 years from manufacture month in UDl label. This warranty is limited to the Buyer of new equipment purchased directly from Drive, or one of its providers, Distributors. Or Agents. During the warranty...
Page 44 Appendix EMC report WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Page 45 ＜ 0.5 L/min. Oxygen Concentration: When 0.5L/min, 90%±3% and 1~5L/min, 93% ±3% (after turning on 5 minutes) Output pressure: 38kPa±5kPa. Power supply failure alarm; High pressure alarm; Low pressure alarm; Low Oxygen Concentration alarm. In case of voltage drop, the equipment starts the power-off alarm.
Page 46 1720 1845 1700-1990 1970 Pulse Modulation 2450 2400-2570 217Hz 5240 5500 5100-5800 5785 WARNING: This equipment has been tested for radiated RF immunity only at selected frequencies and use of nearby emitters at other frequencies could result in improper operation. STATEMENT: The equipment should not be near high-frequency surgical equipment.
Page 47 Table 1 Declaration - electromagnetic emission Emissions test Compliance Electromagnetic Environment - Guidance The oxygen concentrator uses RF energy only for its internal function. RF emissions Group 1 Therefore, its RF emissions are very CISPR 11 low and not likely to cause any interference in nearby equipment.
Page 48 Table 2 Declaration - electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electrostatic ±8 kV contact ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV, ±8 kV, ±15 (ESD) kV air kV air IEC 61000-4-2 Electrical fast...
Page 49 Table 3 Declaration - electromagnetic immunity Immunity test IEC 60601 test level Compliance level 0.15 MHz to 80 MHz 0.15 MHz to 80 MHz Conducted RF bands bands IEC 61000-4-6 between 0.15 MHz and between 0.15 MHz and 80 MHz 80 MHz 10V/m 10V/m...
Page 50 Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal. STATMENT: The DECO2 Oxygen Concentrator is intended for use in the electromagnetic environments specified above. The customer or the user of the...
Page 51 We, Drive DeVilbiss Healthcare, herewith declare that the stated above Essential Performance of the DECO2 Oxygen concentrator meets the requirement of EMC test in according with IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral...
Page 52 Document No.: 5DECO2/5A Rev.: B Date: March,2025 Distributed by: Drive DeVilbiss Healthcare 99 Seaview Blvd Port Washington, NY 11050 www.drivemedical.com Customer service phone number: 877-224-094 Repair Center Contact info: Inspyre Health Systems 1004 Commerce Drive Grafton, OH 44044 Email: service@inspyrehs.com...

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