BMC G2S A20 User manual

User Manual
Auto CPAP / CPAP System
G2S A20 / G2S C20
0123

G2S A20 / G2S C20 User Manual V1.0
Table of Contents
1. Symbols ·································································································· 1
1.1 Control Buttons················································································ 1
1.2 Device Symbols················································································ 1
2. Warning, Caution and Important Tip ······························································· 3
3. Intended Use ···························································································· 3
4. Contraindications ······················································································· 4
5. Specifications···························································································· 5
6. Available Therapies····················································································· 7
7. Glossary ·································································································· 7
8. Model ····································································································· 8
9. Package Contents······················································································· 9
10. System Features······················································································10
11. First Time Setup······················································································11
11.1 Placing the Device··········································································11
11.2 Installing the Air Filter and Filter Cap···················································12
11.3 Connecting to Power·······································································12
11.4 Assembling the Tube and Mask ··························································13
11.5 Using Oxygen with the Device ···························································14
11.6 Inserting the SD Card (Only for the device that equipped with SD card)········15
11.7 Using the Cellular Module ·································································16
11.8 Starting Treatment ·········································································16
12. Routine Use ···························································································16
12.1 Connecting the Tube ·······································································16
12.2 Adjusting the Tube ·········································································16
12.3 Turning on the Airflow ·····································································16
12.4 Heating the Water in the Humidifier ····················································16
12.5 Using the Ramp Button····································································17
12.6 Turning the Device Off·····································································17
13. Heated Humidifier ···················································································17
13.1 Filling the Water Chamber ································································17
13.1.1 Removing the Water Chamber·················································17
13.1.2 Filling Water·······································································17
13.1.3 Inserting the Water Chamber··················································18
13.2 Emptying the Water Chamber····························································19
13.3 Setting the Humidity Level································································19
14. Navigating the Patient Menu·······································································20
14.1 Steps to Navigating the Patient Menu ··················································20
14.1.1 Accessing the Main Interface ··················································20
14.1.2 Bringing up the Initial Setup Interface ·······································21
14.1.3 Accessing the Setup Interface ·················································21
14.1.4 Selecting Options·································································21
14.1.5 Adjusting Options ································································22
14.1.6 Confirming Adjustments ························································22
14.1.7 Turning Pages·····································································22
14.1.8 Exiting the Patient Menu························································22
14.2 Options of the Patient Menu and Corresponding Descriptions ·····················24
15. Alert ····································································································25
16. Cleaning and Disinfection···········································································26
16.1 Cleaning the Mask and Headgear ·······················································26
16.2 Cleaning the Cellular Module ·····························································26
16.3 Cleaning the Water Chamber·····························································26
16.4 Cleaning the Enclosure ····································································27

G2S A20 / G2S C20 User Manual V1.0
16.5 Cleaning the Tube ··········································································27
16.6 Replacing the Air Filter ····································································28
16.7 Disinfection ··················································································28
17. Traveling with the Device ···········································································29
18. Transferring the Device to Another Patient······················································30
19. Reordering·····························································································30
20. Technical Support ····················································································30
21. Disposal································································································30
22. Troubleshooting ······················································································31
22.1 Common Problems in Patients and Corresponding Solutions·······················31
22.2 Common Problems in the Device and Corresponding Solutions ···················33
23. EMC Requirements···················································································34
24. Limited Warranty·····················································································39

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1. Symbols
1.1 Control Buttons
Ramp Button
Mute Button
Knob
1.2 Device 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
Serial Number of the Product
Manufacturer
EC REP
Authorized Representative in the European Community
Disassembly is prohibited
European CE Declaration of Conformity

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Lot number
Non-Ionizing Radiation
SD Card
WEEE Marking
Logo of BMC Medical Co., Ltd.
Air Inlet
Air Outlet

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2. Warning, Caution and Important Tip
WARNING!
Indicate the possibility of injury to the user or operator.
CAUTION!
Indicate the possibility of damage to the device.
IMPORTANT TIP!
Place emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this manual as they apply.
3. Intended Use
The G2S A20 / G2S C20 system is a CPAP (Continuous Positive Airway Pressure) device
designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the
hospital or at home.
The device is to be used only on the instruction of a licensed health care professional. Your
home care provider will make the correct pressure settings according to your health care
professional’s prescription.
Several accessories are available to make your OSA treatment with this device as convenient
and comfortable as possible. To ensure that you receive the safe, 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 device or MR medical devices.
The device and accessories have not been evaluated for safety in an MR environment.
• 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 risk 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 this device, if it is making unusual or harsh sounds, disconnect the power
cord and discontinue use. Contact your home care provider.
CAUTIONS!
• This device is restricted to sale by or on the order of a physician.
• The patient is an intended operator.

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IMPORTANT!
• 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
Studies have shown that the following pre-existing conditions may contraindicate the use of
positive airway pressure therapy for some patients:
Absolute Contraindications: Pneumothorax, mediastinal emphysema; cerebrospinal fluid
leak, traumatic brain injury, or pneumocephalus; shock caused by a variety of conditions
before treatment; active epistaxis; upper gastrointestinal bleeding before treatment; coma
or impaired consciousness making the use of mask during therapy 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 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
IMPORTANTS!
• An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or sedatives may
aggravate your symptoms.
• Please use a mask which meets ISO 17510: 2015.
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.

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5. Specifications
Device Size
Dimensions: 274 mm × 184 mm × 115 mm
Weight: 1.9 kg
Water capacity:
To maximum fill line 360 mL
Product Use, Transport and Storage
Operation Transport and Storage
Temperature: 5°C to 35°C (41˚F to 95˚F) -25°C to 70°C (-13˚F to 158˚F)
Humidity: 15% to 93% Non-condensing 15% to 93% Non-condensing
Atmospheric Pressure: 760 ~1060 hPa 760 ~1060 hPa
Heated Humidifier
Humidifier Settings: off, 1 to 5 (95˚F to 154.4˚F / 35°C to 68°C)
Humidifier Output: No less than 10 mg H2O/L
Environmental Conditions: Maximum airflow, 35°C, 15% relative humidity
Mode of Operation
Continuous
Work Mode
CPAP, Auto
SD Card
The SD card can record patient data and fault information
AC Power Consumption
100 -240 V ~, 50 / 60 Hz, Max 2 A
Device offer to USB Communications Port
5 V 2.0 A
Type of Protection Against Electric Shock
Class II Equipment
Degree of Protection Against Electric Shock
Type BF Applied Part
Degree of Protection Against Ingress of Water
IP22
Pressure Range
4 to 20 hPa (in 0.5 hPa increments), ≤30 hPa under single fault conditions.
Static Pressure Stability
± 0.5 hPa
Ramp
The ramp time ranges from 0 to 60 minutes.

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Sound Pressure Level
<28 dB, when the device is working at the pressure of 10 hPa.
Sound Power Level
<38 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
Automatic leak compensation
The pressure error ≤ ± 1 hPa
when the air leakage is no more than 70 L / min.
Pressure
Range: 0 ~20 hPa
Margin of Error: ± (0.4 hPa + 4%)
Tube
Length: 6 ft. (1.83 m)
Maximum Delivered Gas Temperature
≤43°C
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.

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6. Available Therapies
The device delivers the following therapies:
CPAP
–
Delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of
pressure throughout the breathing cycle. If your health care professional has prescribed
ramp for you, you can press the Ramp Button to reduce the pressure and then
gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep
more comfortably.
Auto
–
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.
Auto
Adjust CPAP pressure automatically to improve patient comfort based on monitoring of
apnea and snoring events.
Auto Off
When this feature is enabled, the device automatically discontinues therapy whenever the
mask is removed.
Auto On
With this feature, the device automatically initiates therapy when you breathe into the mask.
This feature is always enabled.
CPAP
Continuous Positive Airway Pressure.
iCode
A feature that is intended to give access to compliance and therapy management information.
The “iCode” consists of six separate codes displayed in the Patient Menu, each code is a
sequence of numbers. The “iCode QR” and “iCode QR+” display two-dimensional codes.
LPM
Liters Per 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.

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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 therapy feature that is enabled by your home care provider to provide pressure relief
during exhalation.
Standby State
The state of the device when power is applied but the airflow is turned off.
min
Means the time unit “minute”.
h
Means the time unit “hour”.
yy mm dd / mm dd yy / dd mm yy
Denotes date.
8. Model
Model
Product Description
Product
Contents
Optional Accessory
Work Mode
Maximum
Work
Pressure
(hPa)
G2S A20
Device
(2.4-inch TFT)
Tube, Mask,
Cellular Module
CPAP,
Auto
20
G2S C20
Device
(2.4-inch TFT)
CPAP

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9. Package Contents
After unpacking the system, make sure you have everything shown here (Different models of
the product may contain different components):
No.
Articles
Qty.
Notes
1
Device
1
2
Air Filter
2
3
Power Adapter
1
4
Power Cord
1
5
Mask
1
Optional
6
Cellular Module
1
Optional
7
Tube
1
Optional
8
SD Card
1
Optional
9
Carrying Case
1
Optional
10
Enclosed Documents
1
All parts and accessories are not made with natural rubber latex.
The product’s service life is five years if the use, maintenance, cleaning and disinfection are
in strict accordance with the User Manual. If the key components are replaced, the service
life may be prolonged.
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 optional accessories, always follow the instructions enclosed with
the accessories.
•The tube with a diameter of 15mm or 22mm is available.
WARNINGS!
• This device should only be used with the mask and accessories manufactured or
recommended by BMC or with those recommended by your prescribing physician. The use of
inappropriate masks and accessories may affect the performance of the device and impair
the effectiveness of therapy.
• The use of accessories other than those specified, with the exception of cables sold by the
manufacturer of the equipment or system as replacement parts for internal components,
may result in increased emissions or decreased immunity of the equipment or system.
• Do not pile up the long tubing at the head of the bed, as it may wrap around 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.

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10. System Features
Humidifier Indicator
Mute Button
Knob
Ramp Button
Display Screen
Power Indicator
Fig. 10-1
Name
Function
Humidifier Indicator
Indicate the humidity level. There are five levels in total. The
number of indicator lights that light up is directly proportional
to the humidity level. If the indicator lights are off, it means
the humidifier is turned off
Mute Button
Press this button to mute the alert. However, if the problem
causing the alert is not solved, the alert will sound again
two minutes later
Knob
Start treatment and adjust device settings
Ramp Button
Enable the Ramp feature
Display Screen
Display menus for operation, messages, monitoring data,
etc.
Power Indicator
Indicate the power supply status

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SD Card Slot
Communications Port
DC Inlet
Filter Cap (Air Inlet)
Air Outlet
Fig. 10-2
Name
Function
SD Card Slot
Insert the SD card into this slot
Air Outlet
Deliver pressurized air; connects to the tube
Communications Port
Connected to external equipment (Not for connection to
un-recommended devices)
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
11. First Time Setup
11.1 Placing the Device
Place the device on a firm, flat surface.
WARNINGS!
• If the device has been dropped or mishandled, if the enclosure is broken, or if water has
entered the enclosure, disconnect the power cord and discontinue use. Contact your home
care provider immediately.
• If the room temperature is warmer than 95°F (35°C), the airflow produced by the device
may exceed 109.4°F (43°C). The room temperature must be kept below 95°F (35°C) while
the patient uses the device.
CAUTIONS!
• If the device has been exposed to either very hot or very cold temperatures, allow it to
adjust 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 or children away from the device and avoid small objects being inhaled or
swallowed.
• To avoid explosion, this device must not be used in the presence of flammable gases (e.g.

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anesthetics).
• Tobacco smoke may cause tar build-up within the device, leading to the malfunctioning of the device.
• Air must flow freely around the device for it to work properly.
11.2 Installing the Air Filter and Filter Cap
(1) Attach the air filter to the filter cap, as shown in Fig. 11-1.
Filter Cap
Air Filter
Fig. 11-1
(2) Install the filter cap containing the air filter to the device, as shown in Fig. 11-2.
Fig. 11-2
CAUTION!
• The air filter must be in place when the device is operating.
11.3 Connecting 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. 11-3

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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 AC voltage beyond the stated range (see Section 5 “AC Power
Consumption”) may damage the device or cause device failure.
•Connect to appropriate power for proper operation of the device.
CAUTION!
• Inspect the power cord often for any signs of damage. Replace a damaged cord
immediately.
IMPORTANTS!
• 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 Assembling the Tube and Mask
(1) Connect one end of the tube to the air outlet of the device, as shown in Fig. 11-4.
Air Outlet
Tube
Fig. 11-4
(2) Connect the other end of the tube to the mask according to the user manual for the 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 tube. 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
tube.
• If you are using a mask with a separate exhalation port, connect the tube to the exhalation
port. Position the exhalation port so that the vented air is blowing away from your face.
Connect the mask’s connector to the exhalation port.
• If you are using a full-face mask (a mask covering both your mouth and nose), the mask

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must be equipped with a safety (entrainment) valve.
• In order to minimize the risk of CO2rebreathing, the patient should observe the following
instructions:
- Use the accompanying tube and mask provided by BMC.
- Do not wear the mask for more than a few minutes while the device is not operating.
- Use only masks with vent holes. Do not block or try to seal the vent holes in the exhalation
port.
CAUTION!
•When using the tube with a diameter of 15mm, set the tube of the Patient Menu to 15mm
(see Section 14.2 “Options of the Patient Menu and Corresponding Descriptions”).
11.5 Using Oxygen with the Device
Oxygen may be added at the mask connection. Please observe the instructions listed below
when using oxygen with the device.
WARNINGS!
• Connect the oxygen tube to the oxygen inlet of the mask.
• The oxygen supply must comply with the local regulations for medical oxygen.
• Turn on the device before turning on the oxygen. Turn off the oxygen before turning off the
device. Explanation of Warning: When the device is turned off, but the oxygen flow still exists,
oxygen may accumulate within the device's enclosure and pose a fire hazard. Turning off the
oxygen 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 G2S A20 / G2S 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 backflow of oxygen from the patient circuit into the device when the unit is off. Failure to
use the pressure valve could result in a fire hazard.
•Do not connect the device to an unregulated or high pressure oxygen source. The pressure
of oxygen source does not exceed the work pressure of the device.

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11.6 Inserting the SD Card (Only for the device that
equipped with SD card)
Insert the SD card into the SD Card Slot, as shown in Fig. 11-5.
SD Card Slot
Fig. 11-5
If the SD card is inserted correctly, a symbol indicating correct insertion will appear in the
Main Interface on the screen of the device, as shown in Fig. 11-6.
Fig. 11-6
If the SD card is inserted incorrectly, a symbol indicating incorrect insertion will appear in the
Main Interface on the screen of the device, as shown in Fig. 11-7.
Fig. 11-7
CAUTIONS!
• If the SD card is not inserted, there will not be a symbol appear in the Main Interface on the
screen of the device.
• To avoid data loss or any damage to the SD card, the SD card can only be removed after the
device stops delivering air.

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11.7 Using the Cellular Module
For more details, please refer to the corresponding user manual.
11.8 Starting Treatment
Connect the device to a power outlet, press the Knob , and the device will start
delivering air.
WARNINGS!
• Be sure to follow your physician’s instructions on adjusting the settings! To order any
accessories not included with this device, contact your equipment supplier.
• DO NOT connect any ancillary equipment to this device unless recommended by BMC or
your physician. If you suffer from chest discomfort, shortness of breath, stomach bloating, or
severe headache when using the device, contract your physician or qualified medical
personnel immediately.
12. Routine Use
12.1 Connecting the Tube
Connect the power cord, power adapter, and tube 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 tube for any damage or debris. If necessary, clean the tube
to remove the debris. Replace any damaged tube. Make sure that the mask does not leak.
12.2 Adjusting the Tube
Lie down on your bed, and adjust the tube so it is free to move if you turn during sleep.
Adjust the mask and headgear until you have a comfortable fit and until there are no airflow
leaks around the mask.
12.3 Turning on the Airflow
Press the Knob to turn on the airflow. The screen will display treatment pressure and
other information.
12.4 Heating the Water
Pay attention to the humidifier indicator lights when using the humidifier. The indicator lights
indicate the On / Off state of the humidifier. It is off when all indicator lights go out.
CAUTION!
• Observe the water level of the water chamber before using the humidifier. Make sure there
is sufficient water in the water chamber, and avoid heating the device with an empty water
chamber.

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12.5 Using the Ramp Button
Every time the Ramp Button is pressed, 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 the patient fall asleep easily. The screen displays a real-time countdown
of the remaining ramp time in minutes.
CAUTIONS!
• You can press the Ramp Button as often as you wish during sleep.
• The ramp feature is not prescribed for all users.
12.6 Turning the Device Off
Take off the mask and headgear, press and hold the Knob for two seconds, and the
device will stop delivering air. Disconnect the power cord from the power outlet to power off
the device.
CAUTION!
• Do not position the device where it is difficult to disconnect the device.
13. Heated Humidifier
The humidifier is available from your home care 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
Grab the water chamber, and pull it out of the device, 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
Open the cap, as shown in Fig. 13-2, and fill the water chamber with approximately 360 ml
of water, as shown in Fig. 13-3. Make sure that the water does not exceed the maximum
water level line.
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