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JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
No.1 Baisheng Road Development Zone, Danyang, Jiangsu 212300 CHINA
TEL: 86-511-86900833
www.yuwell.com
Metrax GmbH
EC
REP
Rheinwaldstr. 22, 78628 Rottweil, GERMANY
0123
Document No. : 131069-3A
Revision Date: 2024.03
8F-10
Oxygen Concentrator
User's Manual
Do not operate this unit without first
reading and understanding this manual
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Table of Contents
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Summary of Contents for Yuwell 8F-10
- Page 1 JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. No.1 Baisheng Road Development Zone, Danyang, Jiangsu 212300 CHINA TEL: 86-511-86900833 8F-10 www.yuwell.com Oxygen Concentrator Metrax GmbH Rheinwaldstr. 22, 78628 Rottweil, GERMANY User's Manual 0123 Do not operate this unit without first Document No.
- Page 2 SAFETY NOTES TABLE OF CONTENTS INTENDED USE INTENDED PURPOSE: This oxygen concentrator is intended for oxygen supplement. SAFETY NOTES ---------------------------01 - CONTRA-INDICATIONS: Oxygen poisoning and oxygen allergy user/patient DO NOT using this oxygen concentrator. This device is to be used as an oxygen supplement and is NOT considered life-supporting or FEATURES -------------------------------09 - 1 life-sustaining.
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Page 3: Safety Notes
To ensure receiving the therapeutic amount of oxygen delivery while being transported. according to your medical condition 8F-10 oxygen concentrator must: -- be used with settings that have been individually determined or If the electrical source power voltage is unstable that beyond normal prescribed for you at your activity levels with your accessories;... - Page 4 SAFETY NOTES SAFETY NOTES It takes minutes from switching on the oxygen concentrator until it can device(s) stops, then the concentrator is causing the interference. In such be relied upon to deliver the set flowrate and concentration of oxygen. rare cases, interference may be reduced or corrected by one of the following measures: For optimum performance, o not open or turn off the oxygen concentrator frequently, reset after 3～5 minutes.
- Page 5 SAFETY NOTES SAFETY NOTES mask or the oxygen concentrator is located. If unable to leave the room, tripping or strangulation hazard. Always place the power supply cord and you must wait 10 minutes after you have turned the oxygen concentrator nasal cannula in a manner that prevents crushing by casters or others.
- Page 6 SAFETY NOTES FEATURES ●the condition of the patient, Ⅰ. SUMMARY ●the environment in which the patient lives, and This user s manual will tell you about your concentrator and will serve as a ●the ability to resupply the patient with backup supplies of reference as you use your concentrator.
- Page 7 FEATURES FEATURES Ⅲ. SPECIFICATIONS ambient temperature, humidity and atmospheric pressure. ● The measurement uncertainty of Flowrate is ±10%. 1. Power Supply: 230V, 50Hz ● The measurement uncertainty of Oxygen Concentration is ±3%. 2. Input Power: 700VA 9. Altitude: Not higher than 2000 meters above sea level. 3.
- Page 8 FEATURES HANDLING 18. Cannula length DO NOT more than 15.2 m and no twist. Ⅰ. UNPACKING 19. Storage and Transportation Condition: CAUTION: Unless use the oxygen concentrator, retain containers ● Temperature range: -20℃～60℃ and packing materials for storage until use of the concentrator is ●...
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Page 9: Operating ＆ Installation
OPERATING ＆ INSTALLATION OPERATING ＆ INSTALLATION Ⅰ. FEATURE VIEW Safety valve Inlet Flowmeter knob Outlet Display panel Flowmeter Bottle Humidifier tube Maximum level Audio alarm paused Oxygen outlet Anticlockwise Minimum level Humidifier Humidifier filter element Figure 4: Humidifier Components Blue light Green light Yellow light Figure 2: Front View... - Page 10 OPERATING ＆ INSTALLATION 2. Screw securely the bottle back clockwise. Ⅲ. OXYGEN ABSORBING OPERATION (Recommend to use Yuwell Humidifier and its preferred location is TURN ON shown as Figure 2) When pressing the power switch to "│" position, "HELLO" will be shown on 3.
- Page 11 OPERATING ＆ INSTALLATION OPERATING ＆ INSTALLATION NOTE: All the alarms of the device are low priority. NOTE: All the alarm conditions are technical alarm conditions. When the oxygen concentrator starts, the blue, green and yellow indicators will be turned on and the alarm will sound once to ensure the alarm system is working properly, then the blue and yellow indicators will come off.
- Page 12 OPERATING ＆ INSTALLATION OPERATING ＆ INSTALLATION 2. Oxygen concentration is greater than 82%. Green light illuminates, and supplier immediately. panel shows total time. Normal Operation. - The maximum and mean delay of low oxygen flowrate alarm system is 32 s. 3.
- Page 13 OPERATING ＆ INSTALLATION OPERATING ＆ INSTALLATION NOTE: The alarm value is detected by the sensor. Symbol Description Symbol Description Operator's position Serial Number Date of Manufacture The operator is within 1 m of the oxygen concentrator. Medical Device Flow Regulation Ⅴ.
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Page 14: Maintenance
CAUTION: Please only use the accessories that Yuwell provided or NOTE: After cleaning and disinfecting the oxygen concentrator, parts or recommended to ensure the compatibility of the device and the accessories, please wrap them in plastic bags and store them in a accessories. - Page 15 MAINTENANCE MAINTENANCE 2) Allow the oxygen concentrator to air dry, or use a dry towel, before 3) The filter screen must be cleaned or replaced once per month or as operating the oxygen concentrator. necessary. Before delivery to a new patient, after cleaning and Replace the air filter CAUTION: before drying, it should also be disinfected as follows:...
- Page 16 MAINTENANCE MAINTENANCE Put the humidifier parts into 70%～80% medical alcohol, cover and soak for Follow the instructions below to eliminate possible pathogen infection 30 minutes for disinfection. between patients caused by component or accessory contamination. If necessary, preventive maintenance should also be carried out at Ⅳ.
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Page 17: Troubleshooting
TROUBLESHOOTING TROUBLESHOOTING Use the table below to take actions when the oxygen concentrator Symptom Probable cause Solution indicates an abnormal condition. The oxygen 1) The system pressure is 1) Clean or replace the filter. concentrator is Symptom Probable cause Solution too low. -
Page 18: Other Attention Items
TROUBLESHOOTING OTHER ATTENTION ITEMS Ⅰ. GAS PASS OPERATION SKETCH MAP Symptom Probable cause Solution The oxygen 1) Change power source to Heat concentrator is 1) Power voltage is lower. meet the normal voltage Filter Compressor Exchanger working, but the condition. yellow light illuminates, alarm 2) Stop using the device, please contact the supplier... -
Page 19: Emc Information
: φ7mm such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the 8F-10 oxygen concentrator, Ⅳ. DEVICE DISPOSAL including cables specified by the manufacturer. Otherwise, degradation of The lay responsible organization must contact its local authorities to the performance of this equipment could result. - Page 20 EMC INFORMATION EMC INFORMATION Table 1: Guidance and declaration of manufacturer - electromagnetic Table 2: Test specifications for ENCLOSURE PORT IMMUNITY to RF immunity. wireless communications equipment Test IMMUNITY Basic EMC Band frequency TEST LEVEL Phenomenon standard or test Immunity test levels Service Modulation (MHZ)
- Page 21 EMC INFORMATION Table 3: Guidance and declaration of manufacturer - electromagnetic emission Phenomenon Compliance Conducted and radiated RF EMISSIONS Group 1, Class B CISPR 11 Harmonic distortion Class A IEC 61000-3-2 Voltage fluctuations and flicker Complies IEC 61000-3-3...
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