React Health 3B G3 B30VT User manual

User Manual
G3 B30VT
Luna G3 BPAP 30VT

Luna G3 BPAP 30VT (G3 B30VT) User Manual MID-99/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 ································································ 8
7. Glossary·············································································· 9
8. Model ···············································································11
9. Package Contents ·································································12
10. System Features ·································································13
11. First Time Setup ·································································15
11.1 Placing the Device·······················································15
11.2 Installing the Air Filter and Filter Cap / PM2.5 Filter···············15
11.3 Connecting to Power····················································16
11.4 Connecting to Power Cord Locker ····································17
11.5 Assembling the Tubing / Heated Tubing and Mask ················18
11.6 Using Oxygen with the Device ········································19
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·······················································21
12.5 Using the Ramp Feature················································22
12.6 Accessing the iCode·····················································22
12.7 Turning the Device Off··················································22
13. Heated Humidifier ·······························································23
13.1 Filling the Water Chamber ·············································23
13.1.1 Removing the Water Chamber ·······························23
13.1.2 Filling Water ·····················································23
13.1.3 Returning the Water Chamber································24
13.2 Emptying the Water Chamber ·········································25
13.3 Setting the Humidity Level ·············································25
15. Using the Cellular Module and the WiFi kit··································26
15.1 Connecting to Cellular Network ·······································26

Luna G3 BPAP 30VT (G3 B30VT) User Manual MID-99/v1.0
15.2 Connecting to WiFi Network ···········································27
16. Navigating the Patient Menu···················································31
16.1 Steps to Navigating the Patient Menu································31
16.1.1 Accessing the Main Interface ·································31
16.1.2 Bringing up the Initial Setup Interface ······················32
16.1.3 Selecting Options ···············································33
16.1.4 Adjusting Options···············································33
16.1.5 Confirming Adjustments ·······································33
16.1.6 Turning Pages ···················································34
16.1.7 Exiting the Patient Menu ······································34
16.2 Options of the Patient Menu and Corresponding Descriptions ···35
17. Alarm ··············································································37
17.1 Grading for Alarming and Description ································37
17.2 Visual Alarming ··························································37
17.3 Auditory Alarming ·······················································38
17.4 Alarming Silence ·························································38
17.5 Alarming Information and Description ·······························39
17.6 Reposition of Alarming··················································42
17.7 Alarming Journal ·························································42
17.8 Alarming Verification ····················································42
18. Cleaning and Disinfection ······················································43
18.1 Cleaning the Mask and Headgear·····································44
18.2 Cleaning the Water Chamber··········································44
18.3 Cleaning the Transfer Box ·············································45
18.4 Cleaning the Enclosure ·················································45
18.5 Cleaning the Tubing·····················································45
18.6 Replacing the Air Filter / PM2.5 Filter ································46
18.7 Disinfection ·······························································47
19. Traveling with the Device ······················································48
20. Transferring the Device to Another Patient··································49
21. Reordering········································································49
22. Technical Support ·······························································49
23. Disposal ···········································································49
24. Troubleshooting··································································50
24.1 Common Problems in Patients and Corresponding Solutions·····50
24.2 Common Problems in the Device and Corresponding Solutions ·52
25. EMC Requirements ······························································53
26. Limited Warranty ································································58

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1. Symbols
1.1 Control Buttons
Home Button
Start / Stop 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 (15º tilted)
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

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Do not use the product if the 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
Air Inlet
Air Outlet
Company Logo

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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 Luna III B30VT BPAP System 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 patients by
prescription in the home or hospital/institutional environment.
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 3B
Medical 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.

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• 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.
• The device is intended for use by operators trained or experienced in similar equipment.
•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
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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IMPORTANT!
• An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or sedatives may
aggravate your symptoms.
• Please use a mask which meets ISO 17510: 2015.
5. Specifications
Device Size
Dimensions (L x W x H): 265 mm × 145 mm × 114 mm
Weight: 1.7 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, 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 cmH20
Pressure Drop with Humidifier: < 0.4 cmH20 at 60 LPM flow
Maximum Delivered Gas Temperature: ≤43°C
Cellular Module
Receiver Frequency Band: 850/900/1800/1900 MHz
FCCID:XMR201202M35
Max RF power output: 33.0 dBm
WiFi Kit
FCCID: AZY-HF-LPT200
Mode of Operation
Continuous
Work Mode
CPAP, S, AutoS, S/T, T
SD Card
The SD card can record patient data and fault information
AC Power Consumption
100 -240 V ~, 50 / 60 Hz, 2.5A Max
100 -240 V ~, 50 / 60 Hz, 2A Max

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Main device input
24 V, 3.33 A
Device offer to Heated Tubing Communications Port
24 V 18 W
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
Model
Work Mode
Pressure Range
G3 B30VT
CPAP
4.0 ~20.0 cmH20
S, AutoS, T, S/T
IPAP: 4.0 ~30.0 cmH20; EPAP: 4.0 ~25.0
cmH20; in 0.5 cmH20 increments.
Under single fault conditions, ≤30 cmH20 for CPAP mode, ≤40 cmH20 for the other modes.
Pressure Display Accuracy
±(0.8 cmH20+4%)
Static Pressure Stability
±0.5 cmH20
Ramp
The ramp time ranges from 0 to 60 minutes.
Sound Pressure Level
< 26 dB, when the device is working at the pressure of 10 cmH2o.
Sound Power Level
< 34 dB, when the device is working at the pressure of 10 cmH20.

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Maximum Flow
Test Pressures (cmH20)
4
10
15
20
Measured Pressure at the
Patient Connection Port
(cmH20)
3
9
14
19
Average Flow at the Patient
Connection Port (L/min)
90
150
150
150
Maximal Optical Output Power
Less than 1.5 mw maximum average.
Air Tubing
Air tubing
Length
Inner diameter
Tubing
6 ft.(1.83 m)
19 mm
Heated Tubing
6 ft.(1.83 m)
19 mm
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.
PM2.5 Filter
Efficiency: >90% for 2.5 micron dust

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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 turn the Knob to reduce the pressure and then gradually
increase the pressure to the therapeutic pressure setting so that you can fall asleep more
comfortably.
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.
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.
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.
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.

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7. Glossary
Apnea
A condition marked by the cessation of spontaneous breathing.
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.
SmartC
With this feature, the device adjusts Treat P according to the patient's respiratory event
during a certain time.
SmartA
With this feature, the device adjusts Ramp P and Min APAP according to the patient's
respiratory event during a certain time.
SmartB
With this feature, the device adjusts Ramp P and Min APAP according to the patient's
respiratory event during a certain time.
ASV
Under S/T mode, ASV function can be set to be ASV, ASV Auto and Off. If this function is set
to be ASV, the device will predict the minute ventilation according to the real-time collected
air flow data, and adjust the IPAP according to the minute ventilation.
ASV Auto
Under S/T mode, ASV function can be set to be ASV, ASV Auto and Off. If this function is set
to be ASV Auto, while achieving the ASV function, the respiratory events will be judged and
the EPAP will be adjusted according to the respiratory events.
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.
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.

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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.
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
Denotes date.

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8. Model
Model
Product Contents
Work Mode
Maximum
Work
Pressure
(cmH20)
Main Device
Optional Accessory
Mask,
WiFi kit,
Cellular Module,
Heated Tubing,
PM2.5 Filter
G3 B30VT
Main device
(3.5-inch TFT)
CPAP, S, T,
S/T
30

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9. Package Contents
After unpacking the system, make sure you have everything shown here:
No.
Articles
Qty.
Notes
1
Device
1
2
Air Filter
2
3
Power Adapter
1
4
Power Cord
1
5
Mask
1
Optional
6
PM2.5 Filter
1
Optional
7
WiFi kit
1
Optional
8
Cellular Module
1
Optional
9
Tubing
1
10
Heated Tubing
1
Optional
11
SD Card
1
12
Carrying Case
1
13
Accompanying Documents
1
14
Power Cord Locker
1
Optional
Parts and accessories are made with no 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.
The Heated Tubing service life is six months. The WiFi kit and Cellular Module service life is
one year.
WARNINGS!
• This device should only be used with the mask and accessories manufactured or
recommended by 3B Medical 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 and become an entanglement or strangle hazard.
•Do not connect any equipment to the device unless recommended by 3B Medical or your
health care provider.

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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.
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,
etc.
Home Button
Return to the previous menu or main interface.
Knob
Adjust device settings.

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Fig. 10-2
Name
Function
Air Outlet
Deliver pressurized air; connects to the tubing
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
Connects the device to the water chamber
SD Card Slot
Insert the SD card into this slot

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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!
• Always ensure that the device is placed in an area where the screen and indicators are
clearly visible.
• 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.
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 / PM2.5 Filter
(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.

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Fig. 11-2
(3) Change the air filter and filter cap to the PM2.5 filter, as shown in Fig. 11-3.
PM2.5 Filter
Fig. 11-3
CAUTIONS!
• The air filter or the PM2.5 filter must be in place when the device is operating.
•Installing the air filter and filter cap or PM2.5 filter, 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.
Power Adapter
Power Cord
DC Inlet
Fig. 11-4
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.

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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.
• 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) Insert the power cord locker into the device, as shown in Fig. 11-5, and then rotated to
the left for assembly to the device.
DC Inlet
Power Cord Locker
Fig. 11-5
(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 Adapter
Power Cord
DC Inlet
Power Cord Locker
Fig. 11-6
The function of the locker is to prevent the power cord falling off from the power port.
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