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BPAP System User Manual

 

4 / 57 

• Do not use the device or accessories in an environment with electromagnetic equipment 
such  as  CT  scanners,  Diathermy,  RFID  and  electromagnetic  security  systems  (metal 
detectors) as it may cause unacceptable risks to the patient or damage to the device. Some 
electromagnetic sources may not be apparent, if you notice any unexplained changes in the 
performance of the device, if it makes unusual or harsh sounds, disconnect the power cord 
and stop using it. Contact your home care provider. 

CAUTIONS! 

• The device is restricted to sale by or on the order of a physician. 
• The patient is an intended operator. 
• The device is intended for use by operators trained or experienced in similar equipment. 
• Cleaning and disinfection can be performed by the patient. 

IMPORTANT TIP! 

• Read and understand the entire user manual before operating this system. If you have any 
questions concerning the use of this system, contact your home care provider or health care 
professional.

 

4. Contraindications

 

If you have any of the following conditions, tell your doctor before using the device: 
•  Insufficient  respiratory  drive  to  endure  brief  interruptions  in  non-invasive  ventilation 
therapy 
• Acute sinusitis or otitis media 
• Epistaxis causing a risk of pulmonary aspiration 
• Conditions predisposing to a risk of aspiration of gastric contents 
• Impaired ability to clear secretions 
• Hypotension or significant intravascular volume depletion 
• Pneumothorax or pneumomediastinum 
• Recent cranial trauma, cerebrospinal fluid leak or surgery 
• Obviously uncooperative or extremely tense 

The following side effects may occur during treatment:   
- Dryness of the mouth, nose and throat 
- Abdominal bloating 
- Ear or sinus discomfort 
- Eye irritation 
- Skin irritation due to the use of a mask 
- Chest discomfort 

CAUTION! 

•  Contact  your  health  care  professional  if  symptoms  of  sleep  apnea  recur.  Contact  your 
health care professional if you have any questions concerning your therapy.   

Содержание G3 B20A

Страница 1: ...User Manual Respiratory Insufficiency Ventilator and Accessories BPAP System G3 B20A G3 B25S G3 B25A G3 B25VT G3 B30VT G3 B30SV G3 LAB ...

Страница 2: ...ed Tubing and Mask 18 11 6 Using Oxygen with the Device 20 11 7 Inserting the SD Card Only for the device that equipped with SD card 20 11 8 Starting Treatment 21 12 Routine Use 21 12 1 Connecting the Tubing 21 12 2 Adjusting the Tubing 21 12 3 Turning on the Airflow 21 12 4 Heating the Water 22 12 5 Using the Ramp Feature 22 12 6 Accessing the iCode 22 12 7 Turning the Device Off 23 13 Heated Hum...

Страница 3: ...37 17 4 Alarming Silence 38 17 5 Alarm Messages and Description 38 17 6 Reposition of Alarming 41 17 7 Alarm Journal 41 17 8 Alarming Verification 41 18 Cleaning and Disinfection 42 18 1 Cleaning the Mask and Headgear 43 18 2 Cleaning the SpO2 Kit 43 18 3 Cleaning the Water Chamber 43 18 4 Cleaning the Transfer Box 43 18 5 Cleaning the Enclosure 44 18 6 Cleaning the Tubing 44 18 7 Replacing the Ai...

Страница 4: ...tions for Use Operating Instructions Type BF Applied Part mask Class II Double Insulated For indoor use only AC Power DC Power IP22 12 5 mm Diameter Dripping 15º tilted There is high voltage beware of electric shock Hot Surface Serial Number of the Product Manufacturer EC REP Authorized Representative in the European Community ...

Страница 5: ... package is damaged Disassembly is prohibited Maximum water level European CE Declaration of Conformity Product is intended for use by a single patient only Lot number Non Ionizing Radiation SD Card WEEE Marking Logo of BMC Medical Co Ltd Air Inlet Air Outlet ...

Страница 6: ... is intended for adult patients by prescription in the home or hospital institutional environment The G3 LAB BPAP System is a Bi level PAP Bi level Positive Airway Pressure device which is intended to provide non invasive ventilation treatment and titration for patients with Obstructive Sleep Apnea OSA Central Sleep Apnea CSA Mixed Sleep Apnea MSA periodic breathing and Respiratory Insufficiency T...

Страница 7: ...e any questions concerning the use of this system contact your home care provider or health care professional 4 Contraindications If you have any of the following conditions tell your doctor before using the device Insufficient respiratory drive to endure brief interruptions in non invasive ventilation therapy Acute sinusitis or otitis media Epistaxis causing a risk of pulmonary aspiration Conditi...

Страница 8: ... Atmospheric Pressure 760 1060 hPa 760 1060 hPa Heated Humidifier Humidifier Settings Off Auto 1 to 5 95 F to 154 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 Frequenc...

Страница 9: ...0 0 hPa IPAP 4 0 25 0 hPa EPAP 4 0 25 0 hPa in 0 5 hPa increments G3 B25A CPAP S AutoS G3 B25VT CPAP S T S T G3 B30SV CPAP S T CPAP 4 0 20 0 hPa IPAP 4 0 30 0 hPa EPAP 4 0 25 0 hPa in 0 5 hPa increments G3 B30VT CPAP S T S T G3 LAB CPAP AutoCPAP S AutoS T S T Under single fault conditions 30 hPa for CPAP and AutoCPAP mode 40 hPa for the rest modes Pressure Display Accuracy 0 8 hPa 4 Static Pressur...

Страница 10: ...Patient Connection Port hPa 3 10 16 23 29 Average Flow at the Patient Connection Port L min 90 150 150 150 120 When the working pressure is set to the values listed in the table the average flow rate at the patient end should be greater than 80 of the corresponding flow value in the table Test of Maximum Flow rate for G3 B20A Test Pressure Pmin Pmin 1 4 Pmax Pmin Pmin 1 2 Pmax Pmin Pmin 3 4 Pmax P...

Страница 11: ...on and exhalation by increasing pressure when you start to inhale and decreasing pressure when you start to exhale There is no automatic delivery of breathing gas if you do not inhale IPAP Inspiratory Positive Airway Pressure and EPAP Expiratory Positive Airway Pressure are preset by a home care provider AutoS A bi level mode which responds to both your inhalation and exhalation The differential p...

Страница 12: ...evice can adjust Initial P and Min APAP based on the patient s respiratory event during a certain time SmartB In AutoS mode if SmartB is set to on the device can adjust Initial P and Min APAP based on the patient s respiratory event during a certain time ASV In S T mode ASV function can be set to ASV ASV Auto and Off If this function is set to be ASV the device will predict the minute ventilation ...

Страница 13: ... A feature that increases patient comfort at the beginning of treatment It reduces the pressure and then gradually increases it to the prescribed setting so that patient can fall asleep more comfortably Rise Time The time it takes for the device to change from EPAP to IPAP You can adjust this time for your comfort Res Rate Respiratory Rate Number of breaths per minute Reslex A therapy feature that...

Страница 14: ...Oximeter Sensor optional Disposable Pulse Oximeter Sensor optional WiFi kit optional Cellular Module optional Heated Tubing optional PM2 5 Filter optional CPAP S AutoS 20 G3 B25S Main device 3 5 inch TFT CPAP S 25 G3 B25A Main device 3 5 inch TFT CPAP S AutoS 25 G3 B25VT Main device 3 5 inch TFT CPAP S T S T 25 G3 B30VT Main device 3 5 inch TFT CPAP S T S T 30 G3 B30SV Main device 3 5 inch TFT CPA...

Страница 15: ...ce is five years if it is used maintained cleaned and disinfected in strict accordance with the User Manual The Heated Tubing service life is six month The WiFi kit and Cellular Module service life is one year SpO2 Probe and mask are the application parts of the device WARNINGS The device should only be used with the mask and accessories manufactured or recommended by BMC The use of inappropriate ...

Страница 16: ...available accessories of the device When using optional accessories be sure to follow the instructions that come with the accessories 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 operation menus information monitoring data etc Home Button Return to the previous menu or main interface K...

Страница 17: ...ected 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 water chamber to the device SD Card Slot Insert the SD card into this slot CAUTION The pictures in this man...

Страница 18: ...to room temperature approximately 2 hours before beginning setup Make sure 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...

Страница 19: ... operating When installing the air filter and filter cap or PM2 5 filter device must be unplugged 11 3 Connecting Power Supply 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 Note The length of the power cord and po...

Страница 20: ...ged cord immediately IMPORTANT TIPS After interruption and restoration of the power supply the device will restore its pre interruption working status automatically To remove AC power disconnect the power cord from the power outlet 11 4 Connecting to Power Cord Locker 1 Connect the device to power supply in accordance with 11 3 Connecting Power Supply 2 Clip the narrow end of the power cord locker...

Страница 21: ...f the power cord locker 11 5 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 8 Air Outlet Tubing Fig 11 8 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 9 Power Plug Heated Tubing Air Outlet Heated...

Страница 22: ...mask Wear the mask WARNINGS If multiple persons are going to use the device e g rental devices a low resistance main flow bacteria filter should be installed in line between the device and the tubing Pressures must be verified by your home care provider when using spare or optional accessories If you are using a mask with a built in exhalation port connect the mask s connector to the tubing If you...

Страница 23: ... before turning off the device will prevent oxygen accumulation in the device and reduce the risk of fire This warning applies to CPAP devices Oxygen supports combustion Keep the device and the oxygen container away from heat open flames any oily substances or other sources of ignition DO NOT smoke in the area near G3 BPAP System or the oxygen container Sources of oxygen should be more than 1 m aw...

Страница 24: ...commended by BMC or your physician If you suffer from chest discomfort shortness of breath stomach bloating or severe headache when using the device contact your physician or qualified medical personnel immediately 12 Routine Use 12 1 Connecting the Tubing Connect the power cord power adapter and tubing properly in accordance with the instructions in the First Time Setup Chapter 11 Connect the mas...

Страница 25: ...feature is enabled the pressure will drop to the initial pressure and then gradually rise to the prescribed treatment pressure according to the preset ramp time so as to make it easy for the patient to fall asleep 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...

Страница 26: ...r Humidifiers can 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 Fig 13 1 Fig 13 1 WARNING Turn the device off and allow the heating plate and water to cool for approximately 15 minutes 13 1 2 Filling the Water Chamber 1 Open the...

Страница 27: ...water level line CAUTIONS Empty the water chamber when the heated humidifier is not in use Distilled water is recommended IMPORTANT TIP It is not necessary to remove the water chamber from the device The users can open the cap of the water chamber with it being attatched to the divice to fill it with water 13 1 3 Putting the Water Chamber back Close the cap when the water chamber is filled with wa...

Страница 28: ...hamber Open the cap as shown in Fig 13 7 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 Putting the water chamber back according to instructions in 13 1 3 13 3 Setting the Humidity Level After the device is powered on turn the Knob to turn the heated humidifier on or off and to adjust the humidity level acc...

Страница 29: ...roplets in the tubing in the morning after treatment it means that the humidity level is appropriate if there is a large amount of condensed water droplets inside the tubing and or the mask 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 14 Using the SpO2 Kit Connect the SpO2 Kit to the device according to the u...

Страница 30: ... connect to it and a signal icon will appear in the status bar at the top of the device screen There are four different signal icons as listed in Table 1 Table 1 Description of Signal Icons Icon Description Strong signal Moderate signal Weak signal No signal found Note 1 When the signal is weak data transmission may become slow and even stop 2 The Cellular Module will keep searching for signals un...

Страница 31: ...k 1 Insert the WiFi kit into the device and turn on the device The device screen displays the Main Screen shown in Fig 15 1 Turn the Knob until the cursor is on the icon 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 t...

Страница 32: ...page the user can turn the Knob to the right to see the remaining WiFi networks as shown in Fig 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 WiFi networks...

Страница 33: ... password is entered turn 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 and the WiFi symbol wi...

Страница 34: ... cursor stays on the Confirmation Key Press the Knob to connect to the network 16 Navigating the Patient Menu 16 1 Steps to Navigate 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 Press the Start Stop Button and the device will start to deliver air The screen displays the Main Interface...

Страница 35: ...second icon indicates Accessories the third icon is the Mask Setup Icon the fourth icon is the Report Interface Icon the fifth icon is the Initial Setup Icon As you turn the Knob the cursor will switch among the five icons Note As the humidity is turned off the Preheat Function Icon will turn gray as shown in Fig 16 4 16 1 2 Bringing up the Initial Setup Interface After the screen displays the Mai...

Страница 36: ...on a certain option press the Knob and the color of the option is changed meaning that the option is now ajustable as shown in Fig 16 7 by the Humidifier option Fig 16 7 16 1 4 Adjusting Options Adjust the option by turning the Knob As shown in Fig 16 7 the Humidifier option is selected As you turn the Knob clockwise the number increases indicating a higher humidity level As you turn the Knob coun...

Страница 37: ... Fig 16 9 Fig 16 9 16 1 6 Turning Pages When the cursor is on Work screen saver the last option shown in Fig 16 9 the remaining options will appear on a new page if you continue to turn the Knob clockwise as shown in Fig 16 10 Fig 16 10 Note are page turning symbols 16 1 7 Exiting the Patient Menu The users can press the Home button to return to the Main Interface shown in Fig 16 1 ...

Страница 38: ...amp Time Auto 0 Max Ramp In order to increase comfort and help the patient fall asleep easily the pressure can be increased gradually when the Ramp feature is enabled The ramp time during which the initial pressure rises to the preset treatment pressure can be adjusted As you turn the Knob to the nearest point the number increases or decreases by five seconds The screen displays a real time countd...

Страница 39: ...erwise the screen will display need to adjust 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 number sequence and the iCode QR iCode QR mode displays data in two dimensional codes WiFi Connect to WiFi network by adjusting this option Used Time 0 50000 h Use Time displays how long has the device been us...

Страница 40: ...re cautious about the change of the state of equipment 17 2 Visual Alarm The visual alarm levels are indicated by the background of the alarming information on the top of the screen and the color of the LED light under the Knob which is shown as follows Grade Visual Description High Red Red light flickers high grade alarming Intermediate Yellow Yellow light flickers intermediate alarming Low Yello...

Страница 41: ...elivering air Alarming duration time is no less than 30 s Note 1 The alarm will not sound if power failure occurs when the device is in standby state 2 No alarm message will appearon the screen during a power failure Device fault High Priority Technology Alarm An audible alarm will sound if no airflow comes out of the machine the screen will display Device fault Tube disconnected only applies to G...

Страница 42: ... than the warning threshold the screen will display Low SpO2 Setting range Off 70 100 in 1 increments the default setting is 85 Note This function is available only when the device is equipped with SpO2 Kit Leak Middle Priority Function Alarm When the airflow is on an audible alarm will sound if the air leak rate exceeds 150 L min the screen will display Leak The alarming duration time is no less ...

Страница 43: ...ff Please replace tubing Low Priority Technology Alarm When the tubing Alarm feature is enabled an audible alarm will sound if the preset replacement time is reached but the tubing is not replaced the screen will display Please replace tubing Please replace mask Low Priority Technology Alarm When the Mask Alarm feature is enabled an audible alarm will sound if the preset replacement time is reache...

Страница 44: ...ournal will be maintained when the device is powered down but the instantaneous time of power down will not be recorded 17 8 Alarming Verification Turn on the device and then check the alarm system of the device at any time Tube disconnect alarm test 1 When the device is operating normally adjust the device to the appropriate patient settings Disconnect the tube that is connected to the air outlet...

Страница 45: ...ce and its accessories is very important for the prevention of respiratory infections To avoid electric shock always unplug the device before cleaning Use mild soap that is nontoxic to humans Follow the manufacturer s instructions on cleaning the mask and tubing and on determining the frequency of cleaning Before cleaning check that the device is disconnected from the power supply whether the powe...

Страница 46: ... a soft cloth 3 Putting the Water Chamber back according to instructions in 13 1 3 WARNINGS Emptying and cleaning the water chamber daily will help prevent mold and bacteria 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 cleani...

Страница 47: ...osure Wipe the surface of the device with a soft slightly damp cloth CAUTIONS The 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 ...

Страница 48: ...r and filter cap to the PM2 5 filter as shown in Fig 18 6 PM2 5 Filter Fig 18 6 CAUTIONS To avoid material damage do not place the spare air filter PM2 5 Filter in direct sunlight humid environments or temperatures below the freezing point The air filter PM2 5 Filter should be replaced every 6 months It may be replaced more frequently based on actual sanitary conditions Operating the device with a...

Страница 49: ...mponents other than that is recommended is not permitted In order to prevent cross infection of patients or contamination of equipment BSF Breathing System Filter that meets ISO 23328 1 2003 and ISO 23328 2 2002 standards and has medical device registration certificates can be used 1 Different patients need to replace a new BSF before using this equipment 2 When using the BSF please install and op...

Страница 50: ... with you to help security personnel understand the device CAUTIONS Empty the water chamber before packing the device for your trip to prevent any remaining water from entering the device Using the device at an incorrect elevation altitude setting may result in higher airflow pressures than the specified setting Always verify the elevation altitude setting when traveling or relocating If the devic...

Страница 51: ...Medical Co Ltd for technical support and documents 22 Technical Support Please contact BMC directly if you need the circuit diagram of the device and the list of components for certain purposes such as maintenance or connection to other equipment BMC will provide the circuit diagram and or other technical documents in whole or in part according to your needs 23 Disposal When the device reaches the...

Страница 52: ...rized air flows out through the mouth causing dryness of the nasal passage and throat 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 may not be the correct size or type or the mask may be incorrectly positioned resulting in an air leak Narrow the distance between the forehead support of the mask and...

Страница 53: ...er than 13 hPa However the treatment pressure is determined by the patient s conditions and the device will not be able to treat sleep apnea if the treatment pressure is set too low It takes a maximum of four weeks for the patient to adapt to pressurized air Relax and breathe through the nose If the problem still exists contact your physician Obstructive sleep apnea symptoms recur It may be becaus...

Страница 54: ... 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 Contact ...

Страница 55: ...00 3 3 Complies WARNINGS The device should not be used in the vicinity or on the top of other electronic equipment such as cell phone transceiver or radio control products If you have to do so the device should be observed to verify normal operation The use of accessories and power cord which are not specified with the exception of cables sold by the manufacturer of the equipment or system as repl...

Страница 56: ... 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 70 UT 2...

Страница 57: ... 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 apply in...

Страница 58: ... 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 reflection from s...

Страница 59: ...ny part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitte...

Страница 60: ... 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 EXCLUSION MAY NOT APPLY TO YOU To exercise the rights under this warranty contact the local authorized dealers or MAN...

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