BMC Y Series User manual

User Manual
RESmart GII BPAP System
Y / U Series
User Manual
Heated Humidifier
H60
English

User Manual
RESmart GII BPAP System
Y / U Series

RESmart GII BPAP System Y / U Series User Manual V2.1
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 ·································································································· 8
8. Model ····································································································10
9. Package Contents······················································································11
10. System Features······················································································12
11. First Time Setup······················································································13
11.1 Placing the Device··········································································13
11.2 Installing the Air Filter and Filter Cap···················································14
11.3 Connecting to Power·······································································14
11.4 Connecting to Power Cord Locker ·······················································15
11.5 Assembling the Tube and Mask ··························································16
11.6 Using Oxygen with the Device ···························································17
11.7 Inserting the SD Card (Only for the device that equipped with SD card)········17
11.8 Using Optional Kits ·········································································18
11.9 Using the H60 Heated Humidifier ·······················································18
11.10 Starting Treatment········································································18
12. Routine Use ···························································································19
12.1 Connecting the Tube ·······································································19
12.2 Adjusting the Tube ·········································································19
12.3 Turning on the Airflow ·····································································19
12.4 Heating the Water in the Humidifier ····················································19
12.5 Using the Ramp Button····································································19
12.6 Turning the Device Off·····································································20
13. Navigating the Patient Menu·······································································20
13.1 Steps to Navigating the Patient Menu ··················································20
13.1.1 Accessing the Main Interface ··················································20
13.1.2 Bringing up the Initial Setup Interface·······································20
13.1.3 Accessing the Setup Interface ·················································21
13.1.4 Selecting Options·································································21
13.1.5 Adjusting Options ································································21
13.1.6 Confirming Adjustments ························································22
13.1.7 Turning Pages·····································································22
13.1.8 Exiting the Patient Menu························································22
13.2 Options of the Patient Menu and Corresponding Descriptions ·····················24
14. Alarm ···································································································25
14.1 Grading for Alarming and Description ··················································25
14.2 Visual Alarming··············································································25
14.3 Auditory Alarming ··········································································25
14.4 Alarming Silence ············································································26
14.5 Alarming Information and Description··················································26
14.7 Alarming Journal············································································29
15. Cleaning and Disinfection···········································································30
15.1 Cleaning the Mask and Headgear ·······················································30
15.2 Cleaning the Optional Kits ································································30
15.3 Cleaning the Water Chamber of the Humidifier·······································30

RESmart GII BPAP System Y / U Series User Manual V2.1
15.4 Cleaning the Enclosure ····································································30
15.5 Cleaning the Tube ··········································································30
15.6 Replacing the Air Filter ····································································31
15.7 Disinfection ··················································································31
16. Traveling with the Device···········································································32
17. Transferring the Device to another Patient ······················································33
18. Reordering·····························································································33
19. Technical Support ····················································································33
20. Disposal ································································································33
21. Troubleshooting ······················································································34
21.1 Common Problems in Patients and Corresponding Solutions·······················34
21.2 Common Problems in the Device and Corresponding Solutions ···················36
22. EMC Requirements···················································································37
23. Limited Warranty·····················································································42

RESmart GII BPAP System Y / U Series User Manual V2.1
1 / 42
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)
/
For indoor use only
AC Power
DC Power
IP22
≥12.5 mm Diameter, Dripping (15ºtilted)
There are high-pressure, be careful of electric shock
Hot Surface
Serial Number of the Product
Manufacturer
EC REP
Authorized Representative in the European Community
Do not use the product if the package is damaged
Disassembly is prohibited
European CE Declaration of Conformity
Product is intended for use by a single patient only
Lot number

RESmart GII BPAP System Y / U Series User Manual V2.1
2 / 42
Non-Ionizing Radiation
SD Card
Water Filling Prohibited Here
Water Inlet
Directional Indicator for Removing the Water Inlet Cap
Directional Indicator for Screwing the Water Inlet Cap
WEEE Marking
Logo of BMC Medical Co., Ltd.

RESmart GII BPAP System Y / U Series User Manual V2.1
3 / 42
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
BPAP System (Y/U Series) is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which
is intended to provide non-invasive ventilation for patients with obstructive Sleep Apnea
(OSA) and Respiratory Insufficiency. These devices are intended for adult patient by
prescription in the home or hospital/institutional environment.
This device is not intended for life support.
The optional Heated Humidifier used with the Y/U Series together is indicated for taking
humidifying and heating air from the device.
The optional SpO2module used with the Y/U Series together is indicated for monitoring the
patient's SpO2and pulse rate auxiliarily.
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.
• To ensure that you receive the safe, effective therapy prescribed for you, use only BMC
accessories.
•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 device is intended for use by operators trained or experienced in similar equipment.
• The patient is an intended operator.

RESmart GII BPAP System Y / U Series User Manual V2.1
4 / 42
•Cleaning and disinfection can be performed by the patient.
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
If you have any of the following conditions, tell your doctor before using this 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
IMPORTANT!
• An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or sedatives may
aggravate your symptoms.
•Please use the mask which meets ISO17510:2015.
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.

RESmart GII BPAP System Y / U Series User Manual V2.1
5 / 42
5. Specifications
Device Size
Dimensions: 170 mm × 180 mm × 118 mm, or 290 mm × 180 mm × 134 mm (with the
humidifier)
Weight: 1.5 kg, or 2.5 kg (with the humidifier)
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 to 1060 hPa 760 to 1060 hPa
Mode of Operation
Continuous
Work Mode
CPAP, S, AutoS, AutoCPAP, S/T, T
SD Card
SD card can record patient data and fault information.
AC Power Consumption
100 –240 V ～2 –1 A, 50 / 60 Hz
Main Device offer to USB Communications Port
5 V 2.0 A
Main Device offer to Humidifier
24 V 1.5 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
IPAP: 4.0 ～20.0 hPa (only applies to Y-20T, U-20T); 4.0 ～25.0 hPa (only applies to Y-25T,
U-25T); 4.0 ～30.0 hPa (only applies to Y-30T, U-30T, U-30AT); in 0.5 hPa increments.
EPAP: 4.0 ～20.0 hPa (only applies to Y-20T, U-20T); 4.0 ～25.0 hPa (only applies to
Y-25T, Y-30T, U-25T, U-30T, U-30AT); in 0.5 hPa increments.
CPAP mode: 4.0 ～20.0 hPa
Under single fault conditions, ≤30 hPa for CPAP mode, ≤40 hPa for the rest modes.

RESmart GII BPAP System Y / U Series User Manual V2.1
6 / 42
Pressure Display Accuracy
± (0.8 hPa＋4%)
Static Pressure Stability
± 0.5 hPa
Ramp
The ramp time ranges from 0 to 60 minutes.
Sound Pressure Level
< 30 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 Pressure (hPa)
4
9
15
20
25
Measured Pressure at the
Patient Connection Port
(hPa)
3
8
14
19
24
Average Flow at the Patient
Connection Port (L/min)
93.2
97.6
98.1
98.5
99.1
SpO2
Range: 0 ～100%
The margin of error for SpO2between 70% and 100% is ± 3%. No strict accuracy
requirements for SpO2below 70%.
Pulse Rate
Range: 40 ～240 BPM
Margin of Error: ± 1%
Wavelengths
Red: 663 nanometers
Infrared: 890 nanometers
Maximal Optical Output Power
Less than 1.5 mW maximum average.
Tube
Length: 6 ft. (1.83 m)
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.

RESmart GII BPAP System Y / U Series User Manual V2.1
7 / 42
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.
AutoCPAP – Delivers CPAP therapy and provides an air pressure no less than the prescribed
one based on the patient’s needs.
AutoS – A bi-level mode which responds to both your inhalation and exhalation. The
differential pressure of IPAP and EPAP are presetted by home care provider. While working in
auto feature, the device will automatically adjust the IPAP and EPAP if it detects a sleep
apnea.
S – A bi-level mode which responds to both your inhalation and exhalation by increasing
pressure when you start to inhale and decreasing pressure when you start to exhale. There is
no automatic delivery of a breath you do not inhale. IPAP (Inspiratory Positive Airway
Pressure) and EPAP (Expiratory Positive Airway Pressure) are preset by home care provider.
S/T – A bi-level mode which responds to both your inhalation and exhalation by increasing
pressure when you start to inhale and decreasing pressure when you start to exhale. If you
do not start inhaling within a set time, the device automatically starts inhalation. When the
device starts inhalation, it controls the time of inhalation and automatically decreases the
pressure for exhalation within a set time.
T – A bi-level mode which the device automatically starts inhalation and exhalation,
automatically controls the time of inhalation and that of exhalation according to the preset
parameter.

RESmart GII BPAP System Y / U Series User Manual V2.1
8 / 42
7. Glossary
Apnea
A condition marked by the cessation of spontaneous breathing.
Auto-CPAP
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
When this feature is enabled, the device automatically initiates therapy when you breathe
into the mask.
CPAP
Continuous Positive Airway Pressure.
EPAP
Expiratory Positive Airway Pressure.
IPAP
Inspiratory Positive Airway Pressure.
iCode
A feature that is intended to give access to compliance and therapy management information.
iCode provides access to the patient's compliance data during a recent time period. The
iCode mode displays data in sequences of characters. The iCode QR and iCode QR+ mode
display data in 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.
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.
Rise Time
The time it takes for the device to change from EPAP to IPAP. You can adjust this time for
your comfort.

RESmart GII BPAP System Y / U Series User Manual V2.1
9 / 42
Res Rate
Respiratory Rate. Number of breaths per minute.
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
Means the date.

RESmart GII BPAP System Y / U Series User Manual V2.1
10 / 42
8. Model
Model
Product Contents
Work Mode
Maximum
Work
Pressure
(hPa)
Main Device
Optional
Accessory
Y-20T
Main device
(3.5-inch
LCD)
Heated Humidifier,
SpO2 Kit, Wi-Fi Kit,
Cellular Module,
SpO2&Wi-Fi Kit,
SpO2&GPRS Kit
CPAP, S, S/T, T
20
Y-25T
Main device
(3.5-inch
LCD)
CPAP, S, S/T, T
25
Y-30T
Main device
(3.5-inch
LCD)
CPAP, S, S/T, T
30
U-20T
Main device
(2.4-inch
LCD)
CPAP, S, S/T, T
20
U-25T
Main device
(2.4-inch
LCD)
CPAP, S, S/T, T
25
U-30T
Main device
(2.4-inch
LCD)
CPAP, S, S/T, T
30
U-30AT
Main device
(2.4-inch
LCD)
CPAP, S, AutoS,
AutoCPAP, S/T, T
30

RESmart GII BPAP System Y / U Series User Manual V2.1
11 / 42
9. Package Contents
After unpacking the system, make sure you have everything shown here (Different models of
the product contain different components):
No.
Articles
Qty.
Notes
1
Main Device
1
2
Heated Humidifier
1
Optional
3
Shield
1
4
Air Filter
2
5
Power Adapter
1
6
Power Cord
1
7
SpO2 Kit
1
Optional
8
Wi-Fi Kit
1
Optional
9
Cellular Module
1
Optional
10
SpO2&Wi-Fi Kit
1
Optional
11
SpO2&GPRS Kit
1
Optional
12
SD Card
1
Optional
13
Carrying Case
1
14
User Manual
1
15
Quick Operation Manual
1
16
Power Cord Locker
1
All parts and accessories are not made with natural rubber latex.
The product’s service life shall be 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 could be prolonged.
SpO2Probe is applied part.
IMPORTANT!
• 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.
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.

RESmart GII BPAP System Y / U Series User Manual V2.1
12 / 42
•When the insulation layer of the SpO2probe cable is damaged, do not connect the probe to
the patient.
•Please contact BMC to buy the SD card if you need it.
10. System Features
Humidifier Indicator
Mute Button
Knob
Ramp Button
Display Screen
Power Indicator
Air Outlet
Humidifier Connector
Shield
Fig. 10-1
Name
Function
Humidifier
Indicator
Indicate the humidity level. There are five levels in total. The number of
blue indicator lights that light up is directly proportional to the humidity
level. If none of the indicator lights light up, 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 with the green indicator light
Air Outlet
Deliver pressurized air; connected to the tube or the air inlet of the
humidifier
Humidifier
Connector
Provide power to the humidifier which is connected to the main device
Shield
Connect the humidifier to the main device after this shied is removed

RESmart GII BPAP System Y / U Series User Manual V2.1
13 / 42
SD Card Slot
Communications Port
DC Inlet
Filter Cap
Fig. 10-2
Name
Function
SD Card Slot
Insert the SD card into this slot
Communications Port
Connected to SpO2Kit, Wi-Fi Kit, Cellular Module, SpO2&Wi-Fi
Kit or SpO2&GPRS Kit (Not for connection to unrecommended
devices)
DC Inlet
An inlet for the DC power supply
Filter Cap
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 objects (such as pests) are not blocking or
entering the filter or vents of the device.
• Keep pets or children away from the device.
• To avoid explosion, this device must not be used in the presence of flammable gases (e.g.
anesthetics).

RESmart GII BPAP System Y / U Series User Manual V2.1
14 / 42
• 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 CapAir Filter
Fig. 11-1
(2) Install the filter cap containing the air filter to the main device, as shown in Fig. 11-2.
Fig. 11-2
CAUTIONS!
• The air filter must be in place when the device is operating.
•Installing the air filter and filter cap, device must be unplugged.
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.
DC Inlet
Main Device
Power Adapter
Power Cord
Fig. 11-3
Note: The length of the power cord and power adapter is 1.5 m and 1.8 m respectively
without the function of preventing electromagnetic interference.

RESmart GII BPAP System Y / U Series User Manual V2.1
15 / 42
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.
CAUTION!
• Inspect the power cord often for any signs of damage. Replace a damaged cord
immediately.
IMPORTANT!
• 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) Assemble the power cord locker to the device directed by the positioning groove.
Positioning Groove
Power Cord Locker
DC Inlet
Fig. 11-4
(2) Open the power cord locker, plug the power cord to the power supply, and press the
locker downward to fix the power cord into the power port.
Power
Cord
Locker
DC Inlet
Power Adapter
Power Cord
Fig. 11-5
The function of the locker is to prevent the power cord falling off from the power port.

RESmart GII BPAP System Y / U Series User Manual V2.1
16 / 42
11.5 Assembling the Tube and Mask
(1) Connect one end of the tube to the air outlet of the main device, as shown in Fig. 11-6. If
the main device is used with a humidifier, connect one end of the tube to the air outlet of the
humidifier, as shown in Fig. 11-7.
Air Outlet
Tube
Fig. 11-6
Air Outlet
Tube
Fig. 11-7
(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
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.