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Yuwell BreathCare PAP User Manual
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Yuwell BreathCare PAP User Manual

Yuwell BreathCare PAP User Manual

Positive airway pressure units
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User manual
BreathCare PAP
Positive Airway Pressure Units

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Summary of Contents for Yuwell BreathCare PAP

  • Page 1 Copy And Reedit Prohibited User manual BreathCare PAP Positive Airway Pressure Units...
  • Page 2 Copy And Reedit Prohibited Welcome The YH-680A, and YH-680B are Yuwell’s Auto Continuous Positive Airway Pressure devices (Auto CPAP). Warning Read this entire user manual before using the device. Caution This device is restricted to sale by or on the order of a physician.
  • Page 3 Copy And Reedit Prohibited Content 1. Introduction of the device ..............01 2. Contraindications ................01 3. Warnings ....................01 4. Precautions ..................03 5. Adverse reactions ................04 6. Package table ..................05 7. Picture and explanation for product ..........05 8. Explanation of button and icons ............07 9.
  • Page 4 YUWELL. Do not position next to a curtain that blocks the flow of cooling air, thereby causing the •...
  • Page 5 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BreathCare PAP, including cables specified by the manufacturer. Other- wise, degradation of the performance of this equipment could result.
  • Page 6 Do not modify this device without authorization of the manufacturer or open this device • by yourself, contact YUWELL when the device needs repairing. Restrictions on the device connection to other equipment or network/data couplings, • other than those forming part of an ME system.
  • Page 7 The manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to service personnel in parts repair. Use only vented masks recommended by YUWELL or by your doctor with this device. • Fitting the mask without the device blowing air can result in rebreathing of exhaled air.
  • Page 8 Copy And Reedit Prohibited Drying of the nose, mouth, or throat • Nosebleed • • Bloating Ear or sinus discomfort • Eye irritation • Skin rashes. • 6. Package table Name Quantity Name Quantity Air filter Main device SD card (optional) Water tank Air tube or Heated tubing User manual...
  • Page 9 Copy And Reedit Prohibited Number Name of parts Explain In standby mode, press this button to start therapy; Start/ Stop button In therapy mode, press this button to stop therapy Adjusts the brightness of the screen by sensing the Light sensor light of the environment around the device Complete device The PAP device...
  • Page 10 Copy And Reedit Prohibited Air outlet Connects air tube/heated tubing to output air Power connection of the Connects here to power heated tubing heated tubing Air outlet of main device to To connect water tank with main device water tank The humidified air passes here and reaches the device Host air adapter outlet.
  • Page 11 Copy And Reedit Prohibited 8.2 Icons Sleep Report Weak signal Ramp No signal Humidity Please wait… Mask-fit Heated tube connected Settings Erase Data Strong signal Data uploaded successfully Medium signal Data upload failed 9. Installation Caution: Do not overfill the water tank in case the water may leak into the air tube/heated tubing and the device.
  • Page 12 Copy And Reedit Prohibited 3.Insert the water tank back to the 4.Place the device on a stable level device following direction surface and plug the power cable shown. When you hear the sound of "da", the water tank is installed- successfully.
  • Page 13 Copy And Reedit Prohibited 10. Therapy 10.1 Start therapy • Fit your mask; • Press start/stop button or breathe normally if the Smart Start is enabled, therapy will start. During the therapy, the real-time average pressure, the initial pressure, the ramp time (min), and the humidity level will be displayed on the screen;...
  • Page 14 Copy And Reedit Prohibited 11. Function 11.1 Function that patient can safely use Sleep Report You can track sleep health on report page after one therapy and read summary report of 7 days and 30 days after a period time of therapy. Following parameters will be displayed. Displayed parameters vary based on different device configuration.
  • Page 15 Copy And Reedit Prohibited 14:31 Ramp/Minute Back Auto Ramp Humidity Mask-fit Settings Sleep Report Figure 3-1: Home Figure 3-2: Ramp Humidity Level Humidifier is designed to moisten the air and to make therapy more comfortable. If you are getting a dry nose or mouth, turn up the humidity level. If there is any water droplets in your mask, turn down the humidity level.
  • Page 16 Copy And Reedit Prohibited After the mask test is completed, if is displayed , it means the mask is worn properly and there is no air leakage; if is displayed , it means the mask is not worn properly, it is recommended to read the mask wearing guide and then put the mask back on or adjust the mask and retest.
  • Page 17 Copy And Reedit Prohibited Tube reminder: When this function is enabled, this can remind you to check and change • the tube. • Reset: When this function is enabled, parameters of the device will be reset to the factory defaults. •...
  • Page 18 Copy And Reedit Prohibited 12.1 Disassembling 1.Disconnect the power adapter 2.Rotate the air tube port (or hold from the main device. the buckle of the heated tubing) and remove the tube from the device. 3.Separate the water tankt from the 4.Release the water tank buckle device following the direction shown and lift the top cover.
  • Page 19 Copy And Reedit Prohibited respiratory infections. • To avoid electric shock, always unplug the device before cleaning. • Use mild soap that is nontoxic to humans. • Before cleaning, check whether the device has been disconnected from the power supply, whether the power cable has been unplugged. Make sure the water tank and heating plate has cooled down to room temperature to avoid burn.
  • Page 20 Copy And Reedit Prohibited CAUTIONS! The device can only be used after the exterior is dry, so that no moisture enters the device. It is recommended to clean the exterior once a week. • 12.2.3 Cleaning and drying the air tube •...
  • Page 21 Copy And Reedit Prohibited Caution Make sure the air filter is fitted at all times to prevent water and dust from entering the device. 12.4 Reassembling After finishing all the cleaning steps, reassemble all these parts together. When the water tank and air tube/heated tubing are dry, you can reassemble the parts.
  • Page 22 Copy And Reedit Prohibited 13.2 Transferring therapy data through WIFI (Optional) The device is equipped with a WIFI module that can transfer therapy data to the designat- ed server. For more information on how to connect the device to a wireless network and check the wireless network signal, therapy data.
  • Page 23 Copy And Reedit Prohibited Modulation mode Data rates WiFi: IEEE802.11b/g/n : 11b：1,2,5.5 ,11Mbps; 11g:6,9,12,18,24,36,48,54Mbps; 11n_HT20: MCS0~7, 65Mbps max; 11n_HT40: MCS0~7,150Mbps max; Bluetooth: BLE4.2 : 1Mbps max; Bandwidth 20MHz bandwidth transmission WiFi: Rated Output Power IEEE802.11b/g/n : 11b: 16dBm; 11g: 15dbm; 11n: 13dbm ; Bluetooth: BLE4.2 : Cellular Module...
  • Page 24 Copy And Reedit Prohibited 13.4.3 Information addressing wireless issues and wireless coexistence Problem Possible Cause Solution(s) Incorrect account password Check account or incorrect format. password and format, try to configure again refer- ring to the instructions. Fail to configure network Too far away from the router Reduce distance...
  • Page 25 Copy And Reedit Prohibited Matrix of the network data streams: Destination of data Protocol types Origin of data streams Addressing scheme streams WiFi module/Cellular serial port Positive Airway private protocol modulel communication Pressure Units MQTT WiFi module server IP addressing MQTT Cellular module server...
  • Page 26 Copy And Reedit Prohibited 15. Trouble shooting When your device has troubles, look for the following table to find solution. Contact your physician or your provider if you cannot solve your problem. Do not try to open the device. 15.1 General troubleshooting Trouble Cause Solution...
  • Page 27 Check the water assemble incorrectly or it is broken correctly; Contact your provider or Yuwell if your water tank is broken Check whether the humid- Humidifier leaking The humidifier is broken ifier is damaged. If dam- aged, please replace the humidifier.
  • Page 28 Copy And Reedit Prohibited 15.2 Other trouble Message in LCD Meaning of error Solution ERROR 1 There is a mistake of pressure Please contact your provider sensor ERROR 2 There is a mistake of flow sensor Please contact your provider ERROR 3 There is a mistake of temperature Please contact your provider...
  • Page 29 Copy And Reedit Prohibited 16. Specification of technology 16.1 Model Tansmission module Model YH-680A YH-680B WiFi+BLE/Cellular module 16.2 Specification of technology Items Specification Input :100-240VAC, 50 Hz-60 Hz,1.8 A max Power Output:24V DC, 3.33A Operate:+5℃~35℃（+41℉~95℉） Temperature Transport :-20℃~60℃（-4℉~140℉） Storage:-20℃~60℃（-4℉~140℉） Operate: relative humidity 15%-90%, Non-condensing Transport: relative humidity 15%-90%, Humidity...
  • Page 30 Copy And Reedit Prohibited Sound pressure level measured Sound pressure level according to ISO 80601-2-70:2020 Sound (CPAP mode) 27±2 dB（A） Sound power level measured Sound power level according to ISO 80601-2-70:2020 (CPAP mode) 35±2 dB（A） Dimensions 265 mm * 135 mm * 105 mm P h y s i c a l (length*width*height) properties...
  • Page 31 O/hPa (adjustable, step is 0.5 cmH O/hPa) Ramp 0~60min (adjustable, step is 5min) or automatic Air leakage 2 L/min at the maximum rated pressure The BreathCare PAP performance at set pressure according to ISO 80601-2-70:2020 is shown below： Test pressures (cmH O/hpa) Maximum flowrate...
  • Page 32 Copy And Reedit Prohibited Pressure 20bpm 10bpm 15bpm (cmH O/hpa) ± [2% of the full scale +4% of the set value] ± [2% of the full scale +4% of the set value] ± [2% of the full scale +4% of the set value] ±...
  • Page 33 Copy And Reedit Prohibited 17. Symbols 17.1 The following symbols may appear on the product or packaging: Symbol Meaning Symbol Meaning Follow instructions for use A warning/caution Type BF applied part Class II equipment Minimum water level Maximum water level Press to start /stop therapy Warning: hot surface Medical device...
  • Page 34 YUWELL has the interpretation about the device's warranty. 19. Repairing 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. 2. The user should follow the instruction of cleaning and safety to guarantee that the device can be used for a long time.
  • Page 35 Copy And Reedit Prohibited 20. List of cables Lengths(m) Name Cable (AC) Cable (DC) 21. EMC information Essential performance: N/A Pass and fail criteria: 1.static pressure deviation not more than twice the airway pressure accuracy (the airway pressure accuracy is ±0.5cmH 2.The temperature at the patient-connection port does not exceed 43℃.
  • Page 36 Copy And Reedit Prohibited 21.2 Compliance information for Immunity test Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Phenomenon Compliance Level Electrostatic discharge (ESD)
  • Page 37 Copy And Reedit Prohibited Test specifications for ENCLOSE PORT IMMUNITY to RF wireless communications equipment (According to IEC61000-4-3) Test Band Service Modulation IMMUNITY Frequency (MHz) TEST LEVEL (MHz) (V/m) Pulse modulation 380 - 390 TETRA 400 18Hz ±5 kHz 430 - 470 GMRS 460, deviation FRS 460...
  • Page 38 Stop therapy and ask YUWELL engineer for help. • Essential performance and basic safety testing should be done every two years. If your device needs to be done, please contact your provider or YUWELL. This device only can be tested by the provider who has been authorized.
  • Page 39 Copy And Reedit Prohibited...
  • Page 40 This limited warranty does not cover: Any damage caused as a result of improper use, abuse, modification or alteration of the product. Repairs carried out by any service organization that has not been expressly authorized by Yuwell to perform such repairs Any damage caused as accident, Act of God or human factor.
  • Page 41 This limited warranty does not cover: Any damage caused as a result of improper use, abuse, modification or alteration of the product. Repairs carried out by any service organization that has not been expressly authorized by Yuwell to perform such repairs Any damage caused as accident, Act of God or human factor.