Yuwell YH-550 User Manual Download Page 4

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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. Otherwise, degradation of the performance 
of this equipment could result.

 

y

Interconnection of this equipment to other equipment which is not the supply one is forbidden.

 

y

Nebulisation or humidification can increase the resistance of breathing system filters and the 
operator must monitor the breathing system filter frequently for increased resistance and blockage 
to ensure the delivery of the therapeutic pressure.

 

y

Failure  to  use  a  mask  or  accessory  that  minimizes  rebreathing  of  carbon  dioxide  or  permits 
spontaneous breathing can cause asphyxiation.

 

y

Keep device far away from the following environments, e.g. magnetic fields, electromagnetic 
fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, 
acceleration, thermal ignition sources and so on.

 

y

Do not block the several holes in your mask, otherwise it will result strangulation.

 

y

Humidity performance of the device can be compromised when used outside the specified ambient 
temperature range or humidity range.

 

y

The performance of the device can be compromised when exposed to environment, for example, 
electrocautery, electrosurgery, defibrillation, X-ray(gamma radiation), infrared radiation, conducted 
transient magnetic fields, magnetic resonance imaging (MRI), and radiofrequency interference.

 

y

When the device is used near the children or disabled persons, the device must be supervised. Do 
not let the children or disabled persons inhale or swallow small parts. Otherwise , it may result in 
choking. 

 

y

Keep the area around the device dry, clean and clear of anything (eg, pets, pests or children) that 
could affect the device hygiene, drop the device, and so on.

 

y

The device is intended for single patient use only. Do not let others use it. 

4. Precautions 

 

y

Using  only  YUWELL  part  and  accessories  with  device.  Non-YUWELL  parts  may  reduce 
effectiveness of the treatment and/or damage the device.

 

y

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. Make sure that the 
mask vent holes are kept clear and unblocked to maintain the flow of the fresh air into the mask.

 

y

Do not use bleach, chlorine, aromatic-based solutions, moisturizing or antibacterial soaps or 
scented oil to clean the device, water tank or air tube. Otherwise it may cause damage and reduce 
the life of these products.

 

y

If you use the humidifier, always place the device on a level surface lower than your head to 
prevent the mask and air tube from filling with water.

 

y

Leave the water tank to cool for ten minutes before handling to allow the water to cool and to make 
sure that the water tank is not too hot to touch.

 

y

Make sure that the water tank is empty before transporting the device.

 

y

This equipment might not offer adequate protection to radio-frequency communication services. 
The  user  might  need  to  take  mitigation  measures,  such  as  relocating  or  re-orienting  the 
equipment.

 

y

The proper placement and positioning of the mask on the face is critical to the consistent operation 
of this equipment.

 

y

Not intended for use with patient whose upper airways have been bypassed.

 

y

The time required for the device to warm from the minimum storage temperature between uses 
until the device is ready for its intended use when the ambient temperature is 20 ℃ is about 2 
hours.

 

y

The time required for the device to cool from the maximum storage temperature between uses until 
the device is ready for its intended use when the ambient temperature is 20℃ is about 2 hours.

 

y

This device is not intended for children, and patients who are physically or mentally deficient can’t 
use the device without assistance or supervision.

5. Adverse reactions

You  should  report  unusual  chest  pain,  severe  headache,  or  increased  breathlessness  to 
your  prescribing  physician.  An  acute  upper  respiratory  tract  infection  may  require  temporary 
discontinuation of treatment.

Summary of Contents for YH-550

Page 1: ...hnology 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 1030400 0A Paper ...

Page 2: ...19 14 Traveling 20 15 Trouble shooting 20 16 Specified of technology 23 17 Symbols 27 18 Limited warranty 28 19 Repairing 29 20 List of cables 29 21 Technical description 29 22 Warranty card 34 Content Welcome The YH 550 is YUWELL s auto adjusting pressure device The YH 350 is YUWELL s continuous positive airway pressure CPAP device Warning Read this entire guide before using the device Caution In...

Page 3: ...angulation y y If you notice any unexplained change in the performance of the device if it is making unusual sounds if the device or the power supply are dropped or mishandled or if the enclosure is broken discontinue use and power off the equipment then contact your provider or YUWELL Service Center y y Do not place the device where it can be bumped or where someone is likely to trip over the pow...

Page 4: ...ies with device Non YUWELL parts may reduce effectiveness of the treatment and or damage the device y y 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 Make sure that the mask vent holes are kept clear and unblocked to maintain the flow of the fresh air into the mask y y Do not u...

Page 5: ...ter tank 1 Air filter 2 Air tube 1 SD card 1 Power adapter and Cable as part of the main device 1 User manual 1 Bag 1 7 Picture and explanation for product Air outlet Dial START STOP button Interface silicone cover Air filter Indicator light the colour is blue and it will light with the backlight of LCD lighting Screen Movable cover component Knob cover component Air outlet of main device to water...

Page 6: ...ifficult to operate the disconnection device The following section will help you install your device by yourself 1 2 1 Place the device on a stable level surface Rotate the knob cover component from the to 2 Pull the knob cover component out 3 4 3 Press the water tank gently and pull it away from the device 4 Open the movable cover component 5 6 5 Fill the distilled water into the water tank pleas...

Page 7: ... the device is delivering gas pressure the heating plate is heating including the situations that the screen shows Large Leakage and the backlight of the screen is off When the level of the humidity is 0 the heat plate is not heating Also if the device is not delivering gas pressure the heat plate will not heat either Ramp 15 Humidity 6 APAP 6 0 15 0 6 0 Pressure Picture 1 therapy f f 10 2 Stop th...

Page 8: ...urn up the humidity If you are getting any moisture in your mask turn down the humidity You can set Humidity level between 0 to 6 where 0 means this function is disabled 1 is the lowest humidity setting and 6 is the highest humidity setting The temperature of each level on the heater plate is as following accuracy is 4 0 OFF 1 33 2 35 3 40 4 45 5 50 6 55 This temperature has been tested with empty...

Page 9: ...our change y y Highlight the Back press dial to back to home page Set Pressure y y At clinical page choose CPAP mode Highlight Initial Pressure or Therapy Pressure press and rotate dial to set suitable value y y You can rotate the dial to the right or to the left to rise or decrease therapy pressure each step is 0 5 cmH2O hPa y y After setting therapy pressure press dial to save your change y y Hi...

Page 10: ...4 0 4 0 Initial Pressure Picture 6 1 Clinical menu CPAP Picture 6 2 Clinical menu APAP 12 Caring for your device It is important that you regularly clean your device to make sure you receive optimal therapy The following sections will help you with disassembling cleaning checking reassembling your device f f 12 1 Disassembling 1 2 1 Pull the power connector out of device 2 Hold the cuff of the air...

Page 11: ... tank and air tube thoroughly and allow to dry out of direct sunlight and or heat Temperature should not exceed 40 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 f 12 3 Checking You should check powe...

Page 12: ... tube firmly onto the assembled mask 13 Therapy data BreathCare PAP records your therapy data for you and your care provider so they can view and make changes to your therapy if required The data is recorded and then transferred to your care provider via a SD card 1 Open the silica gel stopper at the left side of the device 2 Push the SD card into the SD card connector 3 Remove the SD card from th...

Page 13: ...ack After therapy start the screen backlight went off In other case the power do not connect firmly Press dial to turn on the screen light Check the connection of power ensure it connect with device firmly My water tank is leaking Water tank assemble incorrectly or it is broken Check the water assemble correctly Contact your provider if your water tank is broken f f 15 2 Other trouble Message in L...

Page 14: ...evel Sound pressure level measured according to ISO 80601 2 70 2015 CPAP mode BreathCare PAP 32dB A Sound power level Sound power level measured according to ISO 80601 2 70 2015 CPAP mode BreathCare PAP 40dB A Physical properties Dimensions length width height 272 5mm 181mm 93mm or 10 73 7 13 3 7 Weight About 1419 g Air tube Plastic hose about 1 8m Maximum volume of water tank 260 10 mL Materials ...

Page 15: ...ormance Humidification system output 12mg L Relative humidity 50 Humidification system Pressure drop ISO 5367 2014 Flowrate L min Pressure drop cmH2O 30 0 18 60 0 6 90 1 2 Gas leakage at the maximum operating pressure ISO 5367 2014 2 L min Displayed values Value Range Display resolution Pressure measurement Mask pressure 4 20 cmH2O 0 1 cmH2O Value Accuracy Pressure measurement Mask pressure 2 of t...

Page 16: ...ean Authorized Representative Environmental information EU directive 2012 19 EE Waste Electrical and Electronic Equipment WEEE Protected against finger sized objects and against dripping water on the surface of the device f f 17 2 Disposal statement Warning Please contact local authorities your provider or YUWELL to determine the proper method of disposal of this device 18 Limited warranty YUWELL ...

Page 17: ...issions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC61000 3 3 Complies f f 21 2 Compliance information for Immunity test Immunity test Compliance level Electrostatic discharge ESD IEC61000 4 2 8kV contact 15kV air Electrical fast transient burst IEC61000 4 4 2kV for power supply lines Surge IEC61000 4 5 1kV differential mode Voltage dips shor...

Page 18: ...m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent actual modulation it would be worst case f f 21 3 Precautions According to IEC60601 1 2 2014 Brea...

Page 19: ...ice organizations that have not been expressly authorized by Yuwell to perform such repairs Any damage caused as accident act of god or human factor Product which is not involved in quality warranty sheet User sign Date Contact Department User Add Diagnose Tel BreathCare PAP Warranty Card Model SN Invoice number Purchasing date Dealer Feedback Couplet 22 Warranty card ...

Page 20: ... 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 Product which is not involved in quality warranty sheet User sign Date Customer Couplet ...

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