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