3B G3 Series User manual

User Manual
G3 B25A
Luna G3 BPAP 25A

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0
Table of Contents
1. Introduction ································································································ 1
2. Symbols ······································································································ 1
2.1 Control Buttons ·················································································· 1
2.2 Device Symbols ················································································· 1
3. Warning, Caution and Important Tip ······························································ 3
4. Intended Use······························································································· 3
5. Contraindications ························································································ 4
6. Specifications······························································································ 5
7. Available Therapies······················································································ 8
8. Glossary······································································································ 9
9. Model········································································································10
10. Package Contents ····················································································11
11. System Features ························································································12
12. First Time Setup··························································································14
12.1 Placing the Device··········································································14
12.2 Installing the Air Filter and Filter Cap / PM2.5 Filter ·······························14
12.3 Connecting to Power ······································································15
12.4 Connecting to Power Cord Locker····················································16
12.5 Assembling the Tubing / Heated Tubing and Mask······························17
12.6 Using Oxygen with the Device ··························································18
12.7 Inserting the SD Card (Only for the device that equipped with SD card)19
12.8 Starting Treatment···········································································20
13. Routine Use ······························································································20
13.1 Connecting the Tubing ····································································20
13.2 Adjusting the Tubing ········································································20
13.3 Turning on the Airflow ······································································20
13.4 Heating the Water···········································································20
13.5 Using the Ramp Feature···································································21
13.6 Accessing the iCode ······································································· 21
13.7 Turning the Device Off ·····································································21
14. Heated Humidifier ·····················································································22
14.1 Filling the Water Chamber································································22
14.1.1 Removing the Water Chamber ··············································22
14.1.2 Filling Water ·········································································22
14.1.3 Returning the Water Chamber···············································23
14.2 Emptying the Water Chamber··························································24
14.3 Setting the Humidity Level ································································24

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0
15. Using the Cellular Module···········································································25
16. Navigating the Patient Menu······································································26
16.1 Steps to Navigating the Patient Menu ···············································26
16.1.1 Accessing the Main Interface ················································26
16.1.2 Bringing up the Initial Setup Interface ·····································28
16.1.3 Selecting Options ·································································28
16.1.4 Adjusting Options ·································································29
16.1.5 Confirming Adjustments ························································29
16.1.6 Turning Pages ······································································29
16.1.7 Exiting the Patient Menu························································ 30
16.2 Options of the Patient Menu and Corresponding Descriptions··············30
17. Alert·········································································································32
18. Cleaning ·································································································· 33
18.1 Cleaning the Mask and Headgear····················································33
18.2 Cleaning the Water Chamber ··························································33
18.3 Cleaning the Transfer Box·································································34
18.4 Cleaning the Enclosure····································································35
18.5 Cleaning the Tubing ········································································35
18.6 Replacing the Air Filter / PM2.5 Filter ··················································35
19. Traveling with the Device ···········································································36
20. Transferring the Device to Another Patient ··················································· 37
21. Reordering ·······························································································37
22. Technical Support ·····················································································37
23. Disposal ···································································································37
24. Troubleshooting ························································································ 38
24.1 Common Problems in Patients and Corresponding Solutions················38
24.2 Common Problems in the Device and Corresponding Solutions ···········40
25. Information of QoS ····················································································41
26. EMC Requirements····················································································42
27. Limited Warranty······················································································· 48

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1. Introduction
Thank you for your purchase of the Luna BPAP. This User Manual will introduce you to
your device. Please read it carefully. If you experience any difficulties or problems
during use, please contact your homecare provider or physician.
2. Symbols
2.1 Control Buttons
Home Button
Start / Stop Button
Knob
2.2 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)
Electric shock hazard
Hot Surface
Product Serial Number

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Manufacturer
EC REP
Authorized Representative in the European Community
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
Indicates the possibility of injury to the user or operator
Company logo

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3. Warning, Caution and Important Tip
WARNING!
Indicates the possibility of injury to the user or operator.
CAUTION!
Indicates the possibility of damage to the device.
IMPORTANT TIP!
Places emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this manual as they
apply.
4. Intended Use
The Luna G3 BPAP 25A is a Bi-level PAP (Bi-level Positive Airway Pressure) device
designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated
humidifier is indicated for the humidification and warming of air from the flow
generator device. These devices are intended for single-patient use by prescription
in the home or hospital/institutional environment on adult patients. It is to be used on
patients >66 lbs./30 kg for whom CPAP therapy has been prescribed. The system
can deliver bi-level therapy or auto bi-level therapy.
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.
• 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.

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CAUTIONS!
•U. S. federal law restricts this device to sale by or on the order of a physician.
• The patient is the intended operator.
• The device is intended for use by operators trained or experienced in similar
equipment.
• Cleaning and disinfection can be performed by the patient.
IMPORTANT TIP!
• Read and understand the entire user manual before operating this system. If you have any
questions concerning the use of this system, contact your home care provider or health
care professional.
5. 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.
IMPORTANT TIPS!
• An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or
sedatives may aggravate your symptoms.
• Please use a mask which meets ISO 17510: 2015.

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6. 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 cmH2O
Pressure Drop with Humidifier: < 0.4 cmH2O at 60 LPM flow
Maximum Delivered Gas Temperature: ≤ 43°C
Mode of Operation
Continuous
Work Mode
CPAP, AutoCPAP, S, AutoS
SD Card
The SD card can record patient data and fault information
AC Power Consumption
100V - 240 V ～, 50Hz / 60 Hz, 2 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
4 to 25 cmH2O (in 0.5 cmH2O increments)
Under single fault conditions, ≤30 cmH2O for CPAP and AutoCPAP mode, ≤40 cm
for the rest of the modes.

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Pressure Display Accuracy
±(0.8 cmH2O＋4%)
Static Pressure Stability at 10 cmH2O
±0.5 cmH2O
Dynamic Pressure Stability
Pressures (cmH2O)
10BPM
15BPM
20BPM
6.5
±0.5
±0.5
±0.5
10
±1
±1
±1
20
±1
±1
±1
Device with humidification and 22mm Tube or Heated Tubing.
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 cmH2O.
Maximum Flow
Test Pressures (cmH2O)
4
10
15
20
Measured Pressure at the
Patient Connection Port
(cmH2O)
3
9
14
19
Average Flow at the
Patient Connection Port
(L/min)
90
150
150
150
Air Tubing
Air tubing
Length
Inner diameter
Tubing
6 ft.(1.83m)
19mm
Heated Tubing
6 ft.(1.83m)
19mm
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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Cellular Module
Transportation
Requirements
Shock, severe vibration, and moisture should be avoided
in transportation
Frequency Bands
Bands12, 3, 4, 5, 8, 12, 13, 20, 28
Communication
Mode
LTE Cat M1/ NB1
FCC ID
XPY2AGQN4NNN
Security Measures
Authentication
Enforced on all data channels
(outgoing and incoming)
Encryption
Base 128 encoding
1The LTE bands supported by Cellular Module are defined in above, while the
following Table 1 describes the Transmitting and Receiving frequencies.
Table 1 Transmitting and Receiving frequencies
Parameter
Min.
Max.
Unit
Remarks
Frequency
range FDD
Band 12
(700 MHz)
Uplink
699
716
MHz
Module transmit
Downlink
729
746
MHz
Module receive
Frequency
range FDD
Band 28
(700 MHz)
Uplink
703
748
MHz
Module transmit
Downlink
758
803
MHz
Module receive
Frequency
range FDD
Band 13
(700 MHz)
Uplink
777
787
MHz
Module transmit
Downlink
746
756
MHz
Module receive
Frequency
range FDD
Band 20
(800 MHz)
Uplink
832
862
MHz
Module transmit
Downlink
791
821
MHz
Module receive
Frequency
range FDD
Band 5
(850 MHz)
Uplink
824
849
MHz
Module transmit
Downlink
869
894
MHz
Module receive
Frequency
range FDD
Band 8
(900 MHz)
Uplink
880
915
MHz
Module transmit
Downlink
925
960
MHz
Module receive