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4

2. Model

Model

Type

Main components

Working

Mode

MaxPressure

（

cmH2O

）

C-20A

Auto

CPAP

Host Humidifier H10

SpO2 Kit S10(optional)

CPAP
APAP

20

3. Package Contents

Item

Articles

Quantity

Remark

1

Host

1

Standard

2

Humidifier

1

Standard

3

Tubing

1

Standard

4

Mask

1

Standard

5

Adapter

1

Standard

6

User Manual

1

Standard

7

Air Filter

2

Standard

8

SpO2 Kit

1

Optional

9

Carrying Case

1

Standard

10

TF Card

1

Standard

4. Device Components

Fig. 4.1

Fig. 4.2

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6
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9
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Содержание ResPlus C-20A CPAP

Страница 1: ...BEYOND ResPlus C 20A CPAP User Manual Please read this manual carefully before using this product ...

Страница 2: ...authorized in advanced and in writing by BEYOND Medical the material contained in this document must not be reproduced in any means Without a written authorization from BEYOND Medical no institutions companies or individuals have the right to produce sell duplicate or imitate the products contained herein Doing so constitutes an infringement of the scope of our patent protections and constitutes a...

Страница 3: ...er settings 10 9 1 Main Interface Screens 10 9 2 PFCurve interface 11 9 3 Parameter Setting Interface 11 9 4 System Setting Interface 13 9 5 Information Setting Interface 15 9 6 Epworth Interface 16 10 Prompt 18 11 Cleaning Disinfection and Maintenances 18 11 1 Timing between Cleanings 18 11 2 Cleaning 19 11 3 Disinfection 19 11 4 Transferring to Another User 19 12 Troubleshooting 20 13 Specificat...

Страница 4: ...s exist nearby Electromagnetic fields exceeding 3V m under the EN60601 1 2 test conditions The operation of a high frequency device diathermy Electric shocks from a defibrillator or a short wave therapeutic device Radiation such as x ray or CT Electromagnetic field such as MRI Use only BEYOND Medical circuit accessories Do not wear the mask for longer than a few minutes while the device is not in ...

Страница 5: ...re that the device is in a place that cannot be accessed or touched by children who could be entangled injured or strangled by the tube Appliance coupler is used as isolation means for the device please do not position the device so that it is difficult to operate the coupler Do not attempt to modify this device without written authorization from the manufacture Do not place the device next to any...

Страница 6: ...t the power immediately and stop using it 1 4 Contraindications If the user has severe respiratory failure without spontaneous breathing do not use the device If any of the following conditions apply consult the healthcare provider before using the device Absolute contraindications Pneumothorax or mediastinal emphysema cerebrospinal fluid leak traumatic brain injury or pneumocephalus shock caused ...

Страница 7: ...onal CPAP APAP 20 3 Package Contents Item Articles Quantity Remark 1 Host 1 Standard 2 Humidifier 1 Standard 3 Tubing 1 Standard 4 Mask 1 Standard 5 Adapter 1 Standard 6 User Manual 1 Standard 7 Air Filter 2 Standard 8 SpO2 Kit 1 Optional 9 Carrying Case 1 Standard 10 TF Card 1 Standard 4 Device Components Fig 4 1 Fig 4 2 ...

Страница 8: ... Dial cap The metal rod connected to the Dial may come in contact with the external current creating the risk of an electric shock If the Dial cap falls off contact the local distributor to purchase a replacement In case of the failure of any of the buttons contact the local distributor 5 Device Symbols These symbols are provided in the labeling papers to give users safety instructions please read...

Страница 9: ...onnect the mask into the other end of the tubing 6 1 5 Connect the power adapter into the Power Port on the rear of the device 6 1 6 Connect the device to mains power supply The device will display the Standby Interface 6 1 7 Connect the power supply Press the On Off Button to start the device The Connections should appear as shown in Fig 6 1 below Fig 6 1 Put the device on a solid flat surface wh...

Страница 10: ...use the humidifier turn the humidifier off 6 2 5 Ramp Function When using the Ramp Function the device will begin at a low initial pressure and increase to the desired pressure setting in a steady rise over the time period selected by the user After this function is selected press the On Off Button once the device will start to run in accordance with the Ramp Function s settings If the On Off Butt...

Страница 11: ...l be heard when they are properly connected Push the humidifier to connect with the host completely 7 2 2 Separate from the host unit Fig 7 2 2 Press the Humidifier Separation Button while simultaneously pulling the humidifier apart from the host unit 7 2 3 Adding water into the water tank 1 Take out the water tank move the humidifier cover by sliding the Humidifier Cap Key to the right side as sh...

Страница 12: ...it consists with a SpO2 Probe Adapter and Connector The SpO2 Kit is intended to be used for continuous non invasive functional arterial oxygen saturation SpO2 and pulse rate monitoring for adults weighing more than 40 kg 90 pounds The SpO2 Kit is immediately ready to use when it is connected to the main device via the Communications Port Attach the Oxygen Probe sensor to the user s index finger al...

Страница 13: ...ed to the device the Humidifier setting icon in the main Interface is grayed and cannot be accessed SpO2 and Pulse Rate are only displayed when the SpO2 Kit optional parts is correctly attached Icon Meaning 1 The TF card is inserted 2 The device is working 3 The Ramp function has been set 4 The humidifier level has been set 5 Indicates that the parameters setting interface is locked When the devic...

Страница 14: ...ter Setting Interface Under the main interface rotate the Dial button to move the cursor onto the Parameters icon and then press the Dial button for 5 seconds to unlock This will bring you to Parameter Setting Interface screen as shown in Fig 9 3a below Next press the Dial button again and the selected font will turn yellow indicating that the device s parameters can now be set as shown in Fig 9 3...

Страница 15: ...emove the mask while the device is in the Working State Within 15 seconds the device will automatically enter into the Standby State When this function has been turned ON the device will automatically enter into the Standby State whenever the user s mask falls off or the tubing becomes disconnected while the user is asleep Mode APAP C PAP The APAP mode allows pressure to be automatically adjusted ...

Страница 16: ...unction while the device is in CPAP Mode will enable the device to detect the respiratory rhythm of the user This function will lower the pressure in the mask during exhalations to make the user feel more comfortable Ramp 0 60 min This parameter sets the time it takes for the air pressure to ramp up to the final pressure selected by the user MaxPress Humidifier 0 OFF to 5 Maximu m This parameter s...

Страница 17: ...14 Fig 9 4a System Setting Interface Screen 1 Fig 9 4b System Setting Interface Screen 2 Fig 9 4c System Setting Interface Screen with Reset Dialogue Box active ...

Страница 18: ...equently to ensure continued accuracy BackLight 30 600 sec This parameter sets the length of time that the LCD display will be back lit When the user sets a value the backlight will turn off after the set time elapses Brightness 1 5 level This parameter has a five level range The higher the level the greater the screen brightness Language Chinese English Can be switched from English to Chinese Chi...

Страница 19: ...2O TiPressure The 95 output pressure value of the device in the running state within the life cycle measured by usage time Unit is cmH2O AvgLeakage The average leakage value of the device in the running state within the lifecycle Unit is L min RunHrs The duration of running time after the device is shipped from factory This value cannot be cleared AHI Apnea hypopnea index of the device in the usin...

Страница 20: ...17 Fig 9 6a Epworth Interface Screen 1 Fig 9 6b Epworth Interface Screen 2 Fig 9 6c Epworth Interface Screen 3 ...

Страница 21: ...r on the display The warning sound can be cancelled by the Mute Button HUMI FAILURE When the device is connected to the humidifier the device is powered on and the humidifier has been heating for 2 minutes but the humidifier is not working the device will provide a sound prompt via the buzzer and HUMI FAILURE will appear on the display The warning sound can be cancelled by pressing the Mute Button...

Страница 22: ...2 Remove the air filter enclosure from the device and remove the air filter 3 Examine the air filter closely to ensure that is is clean and undamaged 4 Wash the air filter in warm water with mild detergent as instructed above 5 Reinstall the air filter Caution Never install a wet air filter into the device Users should alternate between the two air filters included with the device This will ensure...

Страница 23: ...ry and or irritated when using this device The air is dry in the room Turn up the humidifier level or consult your doctor Dry mouth and throat Likely because the user sleeps with his or her mouth opened so that the pressurized air goes through the mouth which leads to dryness of the nasal passages and throat The setting pressure may be too low You may also want to consult your doctor Eye irritatio...

Страница 24: ...ir flow output is too low If the Ramp function is on it takes time for air flow to rise from the initial pressure to the treatment pressure The air inlet may also be blocked Turn off or change the settings of the Ramp feature Check and clean the air inlet or replace the air filter The blower is always at an abnormally high rotation rate The device is leaking air Contact your device supplier The de...

Страница 25: ... professionals certified by BEYOND Medical are authorized to open the device 13 Specifications Environmental Operating Storage Temperature 5 to 35 41 F to 95 F 20 to 55 13 F to 158 F Humidity 15 to 93 no condensation 15 to 93 no condensation Atmospheric Pressure 700 to 1060 hPa 700 to 1060 hPa Physical Dimensions 165mm 200mm 120mm 280mm 200mm 140mm with humidifier Weight 1 2Kg 2 2Kg with humidifie...

Страница 26: ... flow of ISO 80601 2 70 2015 Standard CPAP Test pressure cmH2O 4 8 12 16 20 Average flow at the user connection port l min 100 120 120 120 120 Note all test data were carried out under conditions with the humidifier and 22mm tube Ramp The ramp time ranges from 0 to 60 minutes SpO2 Range 0 100 The margin of error for SpO2 between 70 and 100 is 3 No strict accuracy requirements for SpO2 below 70 Pul...

Страница 27: ... personnel better understand the device Empty the water tank of the humidifier and allow it to dry completely before packing the device for your trip This will prevent any remaining water from entering into the device Be sure to use the device at the proper elevation setting failure to do so could result in airflow pressures different than the prescribed setting Always verify both your actual elev...

Страница 28: ...e reaches the end of its service life please dispose of the device and its packaging in accordance with local laws and regulations 18 Warranty From the date of purchase the manufacturer provides a one year limited warranty for the host unit and a 3 month limited warranty for the tubing mask and humidifier This limited warranty is only available to the initial consumer It is not transferable For on...

Страница 29: ...TATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LIMITATIONS ON THE DURATION OF IMPLIED WARRANTIES SO THESE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU THIS WRITTEN WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE 19 EMC Requirements Guidance and Manufacturer s Declaration Electromagnetic Emissions Guid...

Страница 30: ...ast transient pulse IEC61000 4 4 2KV for power supply lines 1KV for input output line 2KV for Main power line 1KV for input output lines Mains power quality should be that of a typical home or hospital environment Surge IEC61000 4 5 1K differential mode 2KV common mode 1KV differential mode 2KV common mode Mains power quality should be that of a typical home or hospital environment Voltage dips sh...

Страница 31: ...m the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 80MHz to 800MHz d 2 3 800MHz to 2 5GHz is the maximum normal output power of the transmitter its unit is Watt W and d is the recommended separation distance its unit is meter m Measured magnetic field strengths from a fixed RF transmitter should be less than the compliance level in each freque...

Страница 32: ...ed below according to the maximum output power of the communications equipment Rated maximu m output of transmit ter W Separation Distances According to Frequency of Transmitter 150 kHz 80 MHz d 1 2 80 MHz 800 MHz d 1 2 800 MHz 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recomme...

Страница 33: ...30 U S Agent United Source LLC Email BEYOND united source com Address 1521 Concord Pike Suite 301 Wilmington DE 19803 USA VersionNo U S 20201218 A1 ...

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