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Name of manufacturer ：Suzhou Yuyue Medical Technology Co., Ltd.
Add of manufacturer：No.9 Jinfeng Road, Suzhou Science &
Technology Town, 215163 Suzhou, Jiangsu, PRC
TEL:（+86）0512-67373001
Web address: www.yuyue.com.cn
Shanghai International Holding Corp.GmbH(Europe)
Eiffestrasse 80,20537 Hamburg, Germany
IFU-V-09 version:01
Prepared date：2019-10
BreathCare PAP
Positive Airway Pressure Units
1030400-0A
Paper
User manual
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Summary of Contents for Yuwell YH-550
- Page 1 User manual Name of manufacturer ：Suzhou Yuyue Medical Technology Co., Ltd. Add of manufacturer：No.9 Jinfeng Road, Suzhou Science & Technology Town, 215163 Suzhou, Jiangsu, PRC TEL:（+86）0512-67373001 Web address: www.yuyue.com.cn Shanghai International Holding Corp.GmbH(Europe) BreathCare PAP Eiffestrasse 80,20537 Hamburg, Germany Positive Airway Pressure Units 1030400-0A IFU-V-09 version:01 Prepared date：2019-10...
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Page 2: Table Of Contents
Content 1. Indications for use ............01 Welcome 2. Contraindications ............01 The YH-550 is YUWELL's auto-adjusting pressure device. The YH-350 is 3. Warnings ................ 01 YUWELL's continuous positive airway pressure (CPAP) device. 4. Precautions ..............03 5. Adverse reactions ............04 Warning 6. -
Page 3: Indications For Use
Apnea (OSA) in patients weighing more than 66 lb (30 kg). They are intended for home use only. Center. YH-550 and YH-350 consist of main device, water tank and power adapter. Mask and air tube are y Do not place the device where it can be bumped or where someone is likely to trip over the power purchased. -
Page 4: Precautions
30 cm (12 inches) to any part of the BreathCare y Use only vented masks recommended by YUWELL or by your doctor with this device. Fitting the PAP, including cables specified by the manufacturer. Otherwise, degradation of the performance mask without the device blowing air can result in rebreathing of exhaled air. -
Page 5: Package Table
The following adverse reactions may arise during the course of therapy with the device: y drying of the nose, mouth, or throat y nosebleed Water tank y bloating y ear or sinus discomfort y eye irritation y skin rashes. 6. Package table Power interface Name Quantity... -
Page 6: Explanation Of Button
8. Explanation of button START/ STOP button: Press to start /stop therapy. Dial: Turn to navigate the menu and press to select an option. Turn to adjust the options and press to save your choice. 9. Installation 3. Press the water tank gently and pull it away 4. -
Page 7: Therapy
④ The screen backlight will turn off automatically after two minutes of no action. You can press any button to turn it back on. Caution: When the level of the humidity is 1-6 and the device is delivering gas pressure，the heating plate is heating ( including the situations that the screen shows "Large Leakage"... - Page 8 y Average Leak volume: average air leak volume per minute of the last therapy (L/min). ③ Humidity level: y Total Time: the number of hours of the device working. Humidifier is designed to moisten the air and is designed to make therapy more comfortable. If you y P90: the pressure for the 90 percent of the last therapy (cmH O/hPa).
- Page 9 and 3 is the highest level of FPS. The higher FPS level means more comfortable expiration you will y Rotate the dial, highlight the "Mode" , and then select CPAP or APAP. get. y After mode setting, press dial to save your change. y Date: Adjust the date (year, month, day) displayed on the device.
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Page 10: Caring For Your Device
⑥ Set Humidity Level y At clinical page, Highlight "Humidity Level". y Rotate the dial to the right or left, set your humidity level (0-6level, step value is 1 level). y After setting humidity level, highlight the "Back", press dial to back to home page. Caution: During your therapy, you can go to clinical menu by pressing dial and at the same time. - Page 11 Warning: It is generally not necessary to sterilize your water tank if you are following the cleaning method. When the water tank is contaminated, it can be disinfected by immersing the water tank in a water which temperature is 75℃ ±2℃ for 30 minutes. f 12.3 Checking: You should check power adapter and cable, water tank, air tube and air filter regularly in case of any damage.
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Page 12: Therapy Data
3. Place a new air filter onto the air filter cover; 4. Close the air filter cover. Caution: Make sure the air filter is fitted at all times to prevent water and dust from entering the device. f 12.4 Reassembling: 1. - Page 13 f 15.1 General troubleshooting： f 15.2 Other trouble： Trouble Cause Solution Message in LCD Meaning of error Solution Ensure your mask is fitted correctly. Air is leaking from Mask may be fitted incorrectly. See your mask user guide to check ERROR 1 There is a mistake of pressure Please contact your provider...
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Page 14: Specified Of Technology
16. Specified of technology Sound power level Sound power level measured according to ISO 80601-2-70:2015 (CPAP mode) Items Specifies BreathCare PAP ≤ 40dB（A） Power Powered by adapter (Model: BJE1M-0060-N600/DA-60I24) Physical properties Dimensions 272.5mm * 181mm * 93mm or 10.73'' * 7.13'' * 3.7'' Input: 100~240VAC, 50~60Hz, 2A max (length*width*height) Output: 24V DC, 2.5A... - Page 15 Humidification system Pressure drop Flowrate (L/min) Pressure drop (cmH Maximum pressure 4~20 hPa (adjustable, step is 0.5hPa) or 4~20 cmH (ISO 5367:2014) 0.18 Minimum pressure 4~20 hPa (adjustable, step is 0.5hPa) or 4~20 cmH Ramp 0~45min (adjustable, step is 5minutes) Maximum flowrate The BreathCare PAP performance at set pressure is shown below：...
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Page 16: Symbols
18. Limited warranty Follow instructions for use Press to start /stop therapy YUWELL warrants that your device shall be free from defects in material and workmanship from date of purchase for the period specified below: Temperature limitation for storage and... -
Page 17: Repairing
21.2 Compliance information for Immunity test Immunity test Compliance level 1. If your device is in trouble, please contact YUWELL or provider. This device only can be repaired by the provider who has been authorized. Electrostatic discharge(ESD) IEC61000-4-2 ±8kV contact 2. - Page 18 800-960 800, iDEN 820, CDMA modulation 850, LTE Band 5 18Hz to be done, please contact your provider or YUWELL. This device only can be tested by the provider who has been authorized. 1 720 GSM 1800; CDMA Pulse 1900; GSM 1900;...
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Page 19: Warranty Card
Any damage caused as a result of improper use, abuse, modification or alteration of the product. Repairs carried out by any service organizations that have not been expressly authorized by Yuwell to perform such repairs. Any damage caused as accident, act of god or human factor. - Page 20 Any damage caused as a result of improper use, abuse, modification or alteration of the product. Repairs carried out by any service organizations that have not been expressly authorized by Yuwell to perform such repairs. Any damage caused as accident, act of god or human factor.
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