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BMC G3 A20 User Manual Download Page 49

Auto CPAP / CPAP System User Manual V1.0

 

46 / 51 

25. EMC Requirements 

Guidance and manufacturer's declaration - electromagnetic emissions 

The device is intended for use in the electromagnetic environment specified below. The 

user of the device should ensure that it is used in such an environment. 

Emissions Test

 

Compliance

 

Electromagnetic  Environment  - 

Guidance

 

RF emissions 
CISPR 11 

Group 1 

The device uses RF energy only for 

its internal function. Therefore its RF 

emissions  are  very  low and  are  not 

likely  to  cause  any  interference  in 

nearby electronic equipment 

RF emissions 
CISPR 11 

Class B 

The  device  is  suitable  for  use  in  all 

establishments  including  domestic 

establishments  and  those  directly 

connected  to  the  public  low-voltage 

power  supply  network  that  supplies 

buildings used for domestic purposes 

Harmonic emissions 

IEC 61000-3-2 

Class A 

Voltage fluctuations   

/ flicker emissions 

IEC 61000-3-3 

Complies 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

 

 

 

 

 

 

Summary of Contents for G3 A20

Page 1: ...User Manual Auto CPAP CPAP System G3 A20 G3 C20 0123 ...

Page 2: ...necting the Tubing 18 12 2 Adjusting the Tubing 18 12 3 Turning on the Airflow 18 12 4 Heating the Water 18 12 5 Using the Ramp Feature 19 12 6 Accessing the iCode 19 12 7 Turning the Device Off 20 13 Heated Humidifier 20 13 1 Filling the Water Chamber 20 13 1 1 Removing the Water Chamber 20 13 1 2 Filling Water 20 13 1 3 Returning the Water Chamber 21 13 2 Emptying the Water Chamber 22 13 3 Setti...

Page 3: ...ing the SpO2 Kit 37 18 3 Cleaning the Water Chamber 38 18 4 Cleaning the Transfer Box 38 18 5 Cleaning the Enclosure 39 18 6 Cleaning the Tubing 39 18 7 Replacing the Air Filter PM2 5 Filter 39 18 8 Disinfection 40 19 Traveling with the Device 41 20 Transferring the Device to Another Patient 42 21 Reordering 42 22 Technical Support 42 23 Disposal 42 24 Troubleshooting 43 24 1 Common Problems in Pa...

Page 4: ...Symbols Follow Instructions for Use Operating Instructions Type BF Applied Part mask Class II Double Insulated AC Power DC Power IP22 12 5 mm Diameter Dripping 15ºtilted Hot Surface No SpO2 Alert Serial Number of the Product Manufacturer EC REP Authorized Representative in the European Community Disassembly is prohibited ...

Page 5: ...uto CPAP CPAP System User Manual V1 0 2 51 Maximum water level European CE Declaration of Conformity Lot number Non Ionizing Radiation SD Card WEEE Marking Logo of BMC Medical Co Ltd Air Inlet Air Outlet ...

Page 6: ... effective therapy prescribed for you use only BMC accessories WARNINGS This device is intended for adult use only This device is not intended for life support The instructions in this manual are not intended to supersede established medical protocols Do not bring the device or accessories into a Magnetic Resonance MR environment as it may cause unacceptable risk to the patient or damage to the de...

Page 7: ... impossible giant vocal fold polyp etc Relative Contraindications Severe coronary heart disease complicated with left ventricular failure acute otitis media excessive respiratory secretions and weak cough weak spontaneous breathing nasal or oral tracheal intubation and tracheotomy severe nasal congestion caused by a variety of conditions lung bullae and allergies to breathing masks etc The followi...

Page 8: ...4 F 35 C to 68 C Humidifier Output No less than 15 mg H2O L Environmental Conditions Maximum airflow 35 C 15 relative humidity Maximum Operating Pressure 40 hPa Pressure Drop with Humidifier 0 4 hPa at 60 LPM flow Maximum Delivered Gas Temperature 43 C Cellular Module Receiver Frequency Band 850 900 1800 1900MHz FCCID XMR201202M35 Max RF power output 33 0 dBm WiFi Kit FCCID AZY HF LPT200 Mode of O...

Page 9: ... Pressure Level 28 dB when the device is working at the pressure of 10 hPa Sound Power Level 36 dB when the device is working at the pressure of 10 hPa Maximum Flow Test Pressures hPa 4 10 15 20 Measured Pressure at the Patient Connection Port hPa 3 9 14 19 Average Flow at the Patient Connection Port L min 85 135 140 140 Pressure Range 0 20 hPa Margin of Error 0 4 hPa 4 SpO2 Range 35 100 The margi...

Page 10: ...e Knob to reduce the pressure and then gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably AutoCPAP Delivers CPAP therapy and provides an air pressure no less than the prescribed one based on the patient s needs 7 Glossary Apnea A condition marked by the cessation of spontaneous breathing AutoCPAP Adjust CPAP pressure automatically to im...

Page 11: ...r Minute OSA Obstructive Sleep Apnea Patient Menu The display mode in which you can change patient adjustable device settings such as the starting pressure for the Ramp feature Ramp A feature that may increase patient comfort when therapy is started It can reduce pressure and then gradually increase the pressure to the prescription setting so the patient can fall asleep more comfortably Reslex A t...

Page 12: ...scription Product Contents Optional Accessory Work Mode Maximum Work Pressure hPa G3 A20 Device 3 5 inch LCD Tubing optional SpO2 Kit optional Mask optional WiFi kit optional Cellular Module optional Heated Tubing optional CPAP AutoCPAP 20 G3C20 Device 3 5 inch LCD CPAP ...

Page 13: ...nual If the key components are replaced the service life may be prolonged The Heated Tubing service life is six month The WiFi kit and Cellular Module service life is one year SpO2 Probe is applied part IMPORTANTS If any of the above parts are missing contact your home care provider Contact your home care provider for additional information on the available accessories of this device When using op...

Page 14: ...d the head or neck of the patient during sleep Do not connect any equipment to the device unless recommended by BMC or your health care provider Please contact BMC to obtain an SD card if needed 10 System Features Knob Display Screen Home Button Start Stop Button Fig 10 1 Name Function Start Stop Button Start Stop delivering air Display Screen Display menus for operation messages monitoring data e...

Page 15: ...2 Kit Not for connection to un recommended devices Heated Tubing Port Connected to the plug of the heated tubing DC Inlet An inlet for the DC power supply Filter Cap Air Inlet Place the cap on the air filter which is used to filter dust and pollen in the air entering the device Transfer Box SD Card Slot Fig 10 3 Name Function Transfer Box For the connection of the device to the water chamber SD Ca...

Page 16: ... the device is away from any heating or cooling equipment e g forced air vents radiators air conditioners The device is not suitable for use in high humidity environments Make sure that no water enters the device Make sure that bedding curtains or other items are not blocking the filter or vents of the device Keep pets pests or children away from the device and avoid small objects being inhaled or...

Page 17: ...ecting to Power 1 Insert the plug of the power adapter into the DC Inlet on the back of the device 2 Connect the power cord to the power adapter 3 Plug the other end of the power cord into the power outlet Power Adapter Power Cord DC Inlet Fig 11 4 WARNINGS The device is powered on for use when the power cord and power adapter is connected The Knob turns the blower On Off Use of the device at an A...

Page 18: ...ower disconnect the power cord from the power outlet 11 4 Assembling the Tubing Heated Tubing and Mask 1 Connect one end of the tubing to the air outlet of the device as shown in Fig 11 5 Air Outlet Tubing Fig 11 5 2 Connect the heated tubing joint to the air outlet of the device and then insert the power plug into the heated tubing port on the back of the device as shown in Fig 11 6 Power Plug He...

Page 19: ... be installed in line between the device and tubing Pressures must be verified by your home care provider when alternate or optional accessories are in place If you are using a mask with a built in exhalation port connect the mask s connector to the tubing If you are using a mask with a separate exhalation port connect the tubing to the exhalation port Position the exhalation port so that the vent...

Page 20: ...ainer away from heat open flames any oily substances or other sources of ignition DO NOT smoke in the area near G3 A20 G3 C20 or the oxygen container Sources of oxygen should be located more than 1 m from the device When using oxygen with this system a Pressure Valve must be placed in line with the patient circuit between the device and the oxygen source The pressure valve helps prevent the backfl...

Page 21: ...ied medical personnel immediately 12 Routine Use 12 1 Connecting the Tubing Connect the power cord power adapter and tubing properly according to the instructions in the First Time Setup Chapter 11 Connect the mask and headgear according to the user manual for the mask CAUTION Before each use examine the tubing for any damage or debris If necessary clean the tubing to remove the debris Replace any...

Page 22: ...o the prescribed treatment pressure according to the preset ramp time so as to make the patient fall asleep easily The screen displays a real time countdown of the remaining ramp time in minutes CAUTIONS You can use the ramp feature as often as you wish during sleep The ramp feature is not prescribed for all users 12 6 Accessing the iCode After the device is powered on move the cursor to the icon ...

Page 23: ...e provider The humidifier may reduce nasal dryness and irritation by adding moisture and heat if applicable to the airflow 13 1 Filling the Water Chamber 13 1 1 Removing the Water Chamber Press down the water chamber and then remove it as shown in the figure below Fig 13 1 WARNING Turn the device off and allow approximately 15 minutes for the heater plate and water to cool 13 1 2 Filling Water 1 O...

Page 24: ...ery use and do not surpass the MAX fill line CAUTIONS Empty the water chamber when the heated humidifier is not in use Distilled water is recommended IMPORTANT TIP It is not necessary that remove the water chamber from the device The users can open the cap of the water chamber directly to fill the water 13 1 3 Returning the Water Chamber Close the cap after it is filled with water as shown in Fig ...

Page 25: ...he cap as shown below and pour any remaining water out of the water chamber Fig 13 7 CAUTION Empty and air dry the water chamber when the device is not in use 3 Returning the Water Chamber according to instructions in 13 1 3 13 3 Setting the Humidity Level After the device is powered on turn the Knob to turn on or turn off the heated humidifier and to adjust the humidity level according to instruc...

Page 26: ...ate if there is lots of condensed water droplets inside the tubing and or mask it means that the humidity level is too high and should be set lower Nasal dryness means that the humidity level is too low and should be set higher WARNING Do not touch the heater plate of the device when it is working otherwise you may get burned Turn off the heat when the heated humidifier is not in use 14 Using the ...

Page 27: ...3 14 2 Removing the SpO2 Kit from the Device Disconnect the SpO2 Kit connector from the SpO2 Kit Port as shown in Fig 14 4 Fig 14 4 The SpO2 Kit is intended to be used for continuous non invasive functional arterial oxygen saturation SpO2 and pulse rate monitoring for adults weighting greater than 40 kg The SpO2 Kit is ready to use immediately when you connect it to the device via the SpO2 Kit Por...

Page 28: ...acy of the measurement Nail polish or false nails should be removed before the finger sensor is used or it may cause erroneous measurements results Overly low blood pressure overly low systolic blood pressure severe anemia or hypothermia may cause erroneous measurements results The SpO2 Kit is designed for use with this device only Using an incorrect SpO2 Kit that the difference in the peak wavele...

Page 29: ...l found Note 1 When the GPRS signal is weak data transmission may become slow and even stop 2 The Cellular Module will keep searching for GPRS signals until one is found If the GPRS signal is strong the GPRS icon appears in the Main Screen as shown in Fig 15 2 the GPRS icons of different strength appear in a similar way Fig 15 2 The device screen will not show the GPRS icon if the Cellular Module ...

Page 30: ...n and the screen displays the Initial Setup Interface shown in Fig 15 3 Press the Knob and the first option on the Initial Setup Interface turns blue as shown in Fig 15 4 Fig 15 3 Fig 15 4 2 Turn the Knob until the cursor stays on the WiFi option as shown in Fig 15 5 Press the Knob and the interface shown in Fig 15 6 appears Wait for 0 5 seconds to automatically access the WiFi setup interface Fig...

Page 31: ... on that page the user can turn the Knob to the right to see the remaining WiFi networks as shown in figures 15 8 If the desired WiFi network is not listed disconnect the device from the power supply connect it to the power supply again and then repeat steps 1 2 to search for WiFi networks Keep searching until the desired WiFi network is found Fig 15 7 Fig 15 8 Note are page turning symbols If no ...

Page 32: ... the Knob until the cursor stays on the Confirmation Key Press the Knob to connect to the WiFi network as shown in Fig 15 11 At this moment the user must not perform any operations and should wait 0 15 seconds for the connection result Fig 15 10 Fig 15 11 If the WiFi network is connected successfully the screen will return to the WiFi setup interface displaying connected to the right of the WiFi n...

Page 33: ...accessing the password input interface until the cursor stays on the Confirmation Key Press the Knob to connect to the network 16 Navigating the Patient Menu 16 1 Steps to Navigating the Patient Menu 16 1 1 Accessing the Main Interface Connect the power cord and power adapter properly The screen displays the Main Interface shown in Fig 16 1 Fig 16 1 Note The above interface only applicable to the ...

Page 34: ...n As you turn the Knob the cursor switches among the five icons Note As the humidity levels is off the Preheat Function Icon will become gray as shown in Fig 16 2 16 1 2 Bringing up the Initial Setup Interface After the display screen displays the Main Interface shown in the Fig 16 1 turn the Knob When the cursor is on the icon press the Knob the screen displays the Initial Setup Interface of the ...

Page 35: ... changed meaning that the option can now be adjusted as shown by the Humidifier option in Fig 16 5 Fig 16 5 16 1 4 Adjusting Options Adjust the option by turning the Knob As shown in Fig 16 6 the Humidifier option is selected As you turn the Knob clockwise the numbering increases indicating a higher humidity level As you turn the Knob counterclockwise the numbering decreases indicating a lower hum...

Page 36: ...wn in Fig 16 7 Fig 16 7 16 1 6 Turning Pages When the cursor is onWork screen saver the last option shown in Fig 16 7 the remaining options will appear on a new page if you continue to turn the Knob clockwise as shown in Fig 16 8 Fig 16 8 Note are page turning symbols 16 1 7 Exiting the Patient Menu The users can press the Home to return to the Main Interface shown in Fig 16 1 ...

Page 37: ...ing which the initial pressure rises to the prescribed treatment pressure can be adjusted As you turn the Knob to the nearest point the numbering increases or decreases by five seconds The screen displays a real time countdown of the remaining ramp time in seconds Delay On Off When the humidifier is on this feature allows the airflow to continue for about 15 minutes at a low pressure about 2 hPa a...

Page 38: ... to adjust icon iCode iCode iCode QR iCode QR iCode provides access to the patient s compliance data during a recent time period The iCode mode displays data in sequences of numbers and the iCode QR iCode QR mode displays data in two dimensional codes WiFi Connect to WiFi network by adjusting this option Use Time 0 50000 h Use Time displays how long has the device been used by the patient The use ...

Page 39: ...fier Failure When humidifier is applied an audible alert will sound when the humidifier fails to work the screen will display Humidifier Failure Please Change Filter When the Filter reminder feature is enabled an audible alert will sound if the preset replacement time reaches but without replacing the air filter the screen will display Please Change Filter Please Change Tube When the tubing remind...

Page 40: ... are no user serviceable parts inside Repairs and servicing should only be performed by an authorized service agent CAUTIONS Overheating of the materials could lead to early fatigue of these materials Do not use solutions containing chlorinated lime chlorine or aromatic to clean the device and its accessories Liquid soap containing moisturizing agents or antimicrobials should not be used either Th...

Page 41: ...acteria growth Allow the water in the chamber to cool down to room temperature before removing it from the device CAUTIONS Clean the water chamber only after the water in it cools Make sure that no water enters the device After cleaning rinse the water chamber throughly in clean water to make sure that no soap residue is left then wipe it dry with a lint free cloth so as to prevent calcareous accu...

Page 42: ... device can only be used after the enclosure is dry so that no moisture enters the device It is recommended to clean the enclosure once a week 18 6 Cleaning the Tubing 1 Remove the tubing from the device and mask before cleaning 2 Clean the tubing in warm water which contains washing liquid and then rinse it in clean water thoroughly 3 After cleaning air dry the tubing in a cool well ventilated ar...

Page 43: ... the above cleaning instructions you do not have to disinfect the device and or water chamber If the device is contaminated or used in clinical trials you may purchase disinfectants from a home medical equipment company to disinfect the device Disinfection of the Water Chamber Prior to disinfection clean the water chamber according to Section 18 3 Cleaning the Water Chamber The disinfection method...

Page 44: ...g Always verify the elevation setting when traveling or relocating If the device is used when the atmospheric pressure is out of the stated range See Section 5 the accuracy of the leakage alert will be affected 1 Use the BMC carrying case to carry the device and accessories along with you Do not put them in your checked baggage 2 This device operates on power supplies of 100 240 V and 50 60 Hz and...

Page 45: ...ome care provider If the device malfunctions contact your home care provider immediately Never attempt to open the enclosure of the device Repairs and adjustments must be performed by BMC authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage If necessary contact your local authorized dealer or BMC Medical Co Ltd for technical s...

Page 46: ...uth leading to nasal and throat dryness Use a chin strap to prevent the mouth from opening during sleep or use a full face mask Contact your physician for details Eye irritation The mask size or model may not be correct or the mask is not positioned correctly thereby leading to air leakage Narrow the distance between the forehead support of the mask and the forehead Note that adjusting the mask to...

Page 47: ... is determined according to the patient s conditions and cannot treat sleep apnea if the treatment pressure is set too low It takes a maximum of four weeks to adapt to pressurized air Relax and breathe through the nose If the problem still exists contact your physician Obstructive sleep apnea symptoms recur Probably because the patient sleeps with his or her mouth open and the pressurized air goes...

Page 48: ...e holes in the mask or pressure sensing tubing Contact your equipment supplier It is a faulty device Contact your equipment supplier The device produces very low pressures The air inlet of the device may be blocked Replace the air filter see 18 7 Replacing the Air Filter PM2 5 Filter and clean the air inlet Make sure the air inlet is unblocked The treatment pressure has been changed accidentally C...

Page 49: ...e RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network th...

Page 50: ...00 4 5 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle 70 UT 25 30 cycle At 0 0 UT 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle...

Page 51: ...r and d is the recommended separation distance in meters m Field strengths from fixed RF transmitter as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applied Note 2 These guidelines may not a...

Page 52: ...quipment Rated maximum output of transmitter W 150 kHz 80 MHz p d 17 1 80 MHz 800 MHz p d 35 0 800 MHz 2 5 GHz p d 70 0 0 01 0 12 0 04 0 07 0 1 0 37 0 12 0 23 1 1 17 0 35 0 70 10 3 70 1 11 2 22 100 11 7 3 50 7 00 Note 1 At 80 MHz and 800 MHz the higher frequency range applied Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflectio...

Page 53: ...r in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 450 2 0 3 28 28 710 0 2 0 3 9 9 745 780 810 2 0 ...

Page 54: ...e caused by accident misuse abuse alteration and other defects not related to material or workmanship BMC MEDICAL CO LTD DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS LOSS OF PROFITS OVERHEAD OR CONSEQUENTIAL DAMAGES WHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OF THIS PRODUCT SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES SO THE ABOVE LIMITATION OR E...

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