Luna g3 Cpap Apap User Manual

User Manual
Luna® G3 APAP / Luna® G3 CPAP
Item No: LG3600 / LG3500

Luna® G3 APAP / Luna® G3 CPAP User Manual 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································································································· 8
9. Model ································································································· 10
10. Package Contents ············································································· 10
11. System Features ·················································································· 11
12. First Time Setup ··················································································· 13
12.1 Placing the Device···································································· 13
12.2 Installing the Air Filter and Filter Cap / PM2.5 Filter ························ 13
12.3 Connecting to Power ································································ 14
12.4 Assembling the Tubing / Heated Tubing and Mask ······················· 15
12.5 Using Oxygen with the Device···················································· 17
12.6 Inserting the SD Card (Only for the device that equipped with SD
card) ······························································································ 18
12.7 Starting Treatment····································································· 18
13. Routine Use ························································································ 19
13.1 Connecting the Tubing······························································ 19
13.2 Adjusting the Tubing ·································································· 19
13.3 Turning on the Airflow ································································ 19
13.4 Heating the Water ···································································· 19
13.5 Using the Ramp Feature ···························································· 19
13.6 Accessing the iCode ································································· 20
13.7 Turning the Device Off ······························································· 20
14. Heated Humidifier··············································································· 20
14.1 Filling the Water Chamber ························································· 20
14.1.1 Removing the Water Chamber ········································ 20
14.1.2 Filling Water ··································································· 21
14.1.3 Returning the Water Chamber········································· 22
14.2 Emptying the Water Chamber ··················································· 23

14.3 Setting the Humidity Level ·························································· 23
15. Using the Cellular Module ···································································· 24
16. Navigating the Patient Menu ······························································· 25
16.1 Steps to Navigate the Patient Menu ··········································· 25
16.1.1 Accessing the Main Interface ·········································· 25
16.1.2 Bringing up the Initial Setup Interface ······························· 26
16.1.3 Selecting Options ··························································· 27
16.1.4 Adjusting Options ··························································· 27
16.1.5 Confirming Adjustments ·················································· 28
16.1.6 Turning Pages ································································· 28
16.1.7 Exiting the Patient Menu·················································· 28
16.2 Options of the Patient Menu and Corresponding Descriptions ······ 29
17. Alert ·································································································· 31
18. Cleaning···························································································· 32
18.1 Cleaning the Water Chamber···················································· 32
18.2 Cleaning the Transfer Box ·························································· 33
18.3 Cleaning the Mask and Headgear ············································· 34
18.4 Cleaning the Enclosure······························································ 34
18.5 Cleaning the Tubing ·································································· 34
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 ····························································································· 38
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
1. Introduction
Thank you for your purchase of the Luna® G3 APAP / Luna® G3 CPAP. 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)
Hot Surface
Serial Number of the Product
Manufacturer
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Date of manufacture
Use-by Date
Do not use the product if the package is damaged
Disassembly is prohibited
Maximum water level
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
Logo of BMC Medical Co., Ltd.
Logo of 3B Medical, Inc.
2 / 48
3. 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.
4. Intended Use
The Luna® G3 APAP / Luna® G3 CPAP is a CPAP (Continuous 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.
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.
CAUTIONS!
• U. S. federal law restricts this device to sale by or on the order of a physician.
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• 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 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
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
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.
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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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 to 1060 hPa 760 to 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 hPa
Pressure Drop with Humidifier: < 0.4 hPa at 60 LPM flow
Maximum Delivered Gas Temperature: ≤ 43°C
Mode of Operation
Continuous
Work Mode
LG3600: CPAP,AutoCPAP
LG3500: CPAP
SD Card
The SD card can record patient data and fault information
AC Power Consumption
100 - 240 V ～ , 50 / 60 Hz, 2 A Max
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 20 hPa (in 0.5 hPa increments) ≤ 30 hPa under single fault conditions.
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Static Pressure Stability at 10 cmH2O

±0.5 hPa
Dynamic Pressure Stability

Pressures (cmH2O) 10 BPM 15 BPM 20 BPM
6.5 ±0.5 ±0.5 ±0.5
10 ±1 ±1 ±1
20 ±1 ±1 ±1
Device with humidification and 22 mm Tubing or Heated Tubing.
Ramp
The ramp time ranges from 0 to 60 minutes.
Sound Pressure Level

< 28 dB, when the device is working at the pressure of 10 hPa.
Sound Power Level

< 36 dB, when the device is working at the pressure of 10 hPa.
Maximum Flow
Test Pressures (hPa) 4 8 12 16 20
Measured Pressure at the Patient

3 7 11 15 19
Connection Port (hPa)
Average Flow at the Patient

85 135 140 140 140
Connection Port (L/min)
When the working pressure is set to the values listed in the table, the average
flow rate at the patient end should be greater than 80% of the corresponding
flow value in the table.
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.
Air filter
Type Material Average arrestance
Standard filter Polyurethane > 20% for 10 micron
Polypropylene and Poly
PM2.5 filter > 90% for 2.5 micron
(ethylene terephthalate)
6 / 48
Cellular Module
Shock, severe vibration, and moisture should be
Transportation Requirements
avoided in transportation
Frequency Bands Bands1 2, 3, 4, 5, 8, 12, 13, 20, 28
Communication Mode LTE Cat M1/ NB1
Effective Radiated Power LTE LTE Cat M1/ NB1: ≤ +23 dBm (2100 mW), Class 3
FCC ID XPY2AGQN4NNN
Enforced on all data channels

Authentication
Security Measures (outgoing and incoming)
Encryption Base 128 encoding
1 The 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
Uplink 699 716 MHz Module transmit
range FDD
Band 12
(700 MHz) Downlink 729 746 MHz Module receive
Frequency
range FDD
Band 28
Frequency
range FDD
Band 13
Frequency Uplink 832 862 MHz Module transmit

range FDD
Band 20
Downlink 791 821 MHz Module receive
(800 MHz)
range FDD
Band 5
(850 MHz)
range FDD
Band 8
(900 MHz)
7 / 48
Parameter Min. Max. Unit Remarks

range FDD
Band 4

range FDD
Band 3

range FDD
Band 2
WARNING!
• All other wireless technology emitters must be kept at least 30 cm (12 inches) from
the Cellular Module.
CAUTION!
• Considering the requirements of network security, the cpu on this equipment only
supports the standard of our product software and does not support the operation
of other foreign software.
7. 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.
AutoCPAP – Delivers CPAP therapy and provides an air pressure no less than the
prescribed one based on the patient’s needs.
8. Glossary
Apnea
A condition marked by the cessation of spontaneous breathing.
AutoCPAP
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.
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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 Min APAP, Smart P and Max APAP according to
the patient's respiratory event during a certain time.
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.
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.
9 / 48
9. Model
Product Description Maximum
Work Work
Model Product
Optional Accessory Mode Pressure
Contents (hPa)
Tubing(optional),
Device CPAP,
LG3600 Cellular Module
(3.5-inch LCD) AutoCPAP
(optional),
20
Heated Tubing
Device
LG3500 (optional) CPAP
(3.5-inch LCD)
PM2.5 Filter (optional)
10. 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 Cellular Module 1 Optional
6 Tubing 1 Optional
7 Heated Tubing 1 Optional
8 PM2.5 Filter 1 Optional
9 SD Card 1 Optional
10 Carrying Case 1 Optional
11 Accompanying Documents 1
All parts and accessories are not made with natural rubber latex.
The service life of the device is five years if the use, maintenance, cleaning and
disinfection are in strict accordance with the User Manual. The shelf life of the
device is ten years.
The service life of the Tubing and the Heated Tubing is six months. The shelf life of the
Tubing and the Heated Tubing is 3 years.
WARNINGS!
• The 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.
• Do not pile up the long tubing at the head of the bed, as it may wrap around the
10 / 48
head or neck of the patient during sleep.

• Do not connect any equipment to the device unless recommended by 3B
MEDICAL or your health care provider.
IMPORTANT TIPS!
• 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.
11. System Features

Start / Stop Button
Display Screen
Home Button
Knob
Fig. 10-1
Name Function
Start / Stop Button Start / Stop delivering air
Display menus for operation, messages, monitoring
Display Screen
data, etc.
Home Button Return to the previous menu or main interface
Knob Adjust device settings
11 / 48
Heated Tubing Port
Air Outlet
DC Inlet
Filter Cap (Air Inlet)
Fig. 10-2
Name Function
Air Outlet Deliver pressurized air; connect to the tubing
Heated Tubing Port Connected to the plug of the heated tubing
DC Inlet An inlet for the DC power supply
Cover and secure the air filter, which is used to filter dust
Filter Cap (Air Inlet)
and pollen in the air entering the device
Transfer Box
SD Card Slot
Fig. 10-3
Name Function
Transfer Box For the connection of the device to the water chamber
SD Card Slot Insert the SD card into this slot
CAUTION!
• The pictures in this manual are only for reference, if they are different from the
material object, the latter shall prevail.
12 / 48
12. First Time Setup

12.1 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.
12.2 Installing the Air Filter and Filter Cap / PM2.5 Filter
(1) Attach the air filter to the filter cap, as shown in Fig. 12-1.
Air Filter Filter Cap
Fig. 12-1
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(2) Install the filter cap containing the air filter to the device, as shown in Fig. 12-2.
Fig. 12-2
(3) Change the air filter and filter cap to the PM2.5 filter, as shown in Fig. 12-3.
PM2.5 Filter
Fig. 12-3
WARNINGS!
• Do not block the gas INTAKE PORT, thereby interfering with the therapy.
• Nebulisation or humidification can increase the resistance of breathing system
filters and the operator must monitor the breathing system filter frequently for
increased resistance and blockage to ensure the delivery of the therapeutic
pressure.
CAUTIONS!
• The air filter or the PM2.5 filter must be in place when the device is operating.
• Device must be unplugged when installing the air filter and filter cap or PM2.5
filter.
12.3 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.
14 / 48
DC Inlet
Power Adapter
Power Cord
Fig. 12-4
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.
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 TIPS!
• 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.
12.4 Assembling the Tubing / Heated Tubing and Mask

(1) Connect one end of the tubing to the air outlet of the device, as shown in Fig.
12-5.
Air Outlet
Tubing
Fig. 12-5
15 / 48
(2) Connect the heated tubing joint to the air outlet of the device, and then insert
the power plug into the heated tubing port on the back of the device, as shown in
Fig. 12-6.
Air Outlet Heated Tubing
Heated Tubing Joint
Power Plug
Heated Tubing
Fig. 12-6
CAUTION!
• As the ambient temperature decreases, the humidifier can be reduced to
improve or avoid condensation in the pipeline. If the ambient temperature is too
low, in order to avoid condensation, it is recommended to use the heated tubing.
If the heated tubing is connected correctly, the icon will become a number in
the Main Interface on the screen of the device, as shown in Fig. 12-7.
Fig. 12-7
Turn the Knob to turn on or turn off the heated tubing and to adjust the heat
level according to instructions of the Patient Menu of the device.
There are five heat levels available, and the number of heat level will appear in the
Main Interface on the screen of the device. The number 3 next to the icon
indicating the heat is adjusted to Level 3, as shown in Fig. 12-8.
16 / 48
Fig. 12-8
(3) Connect the other end of the tubing to the mask according to the user manual
for the mask. Wear the mask.
WARNINGS!
• If you are using a mask with a built-in exhalation port, connect the mask’s
connector to the tubing.
• If you are using a mask with a separate exhalation port, connect the tubing 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 CO2 rebreathing, the patient should observe the
following instructions:
- Use only tubing and mask provided by 3B MEDICAL.
- 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.
12.5 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
17 / 48
from heat, open flames, any oily substances, or other sources of ignition. DO NOT
smoke in the area near Luna® G3 APAP / Luna® G3 CPAP 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.
12.6 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. 12-9.
SD Card Slot
SD Card
Fig. 12-9
If the SD card is inserted correctly, a symbol indicating correct insertion will

appear in the Main Interface on the screen of the device.
If the SD card is inserted incorrectly, a symbol indicating incorrect insertion will
appear in the Main Interface on the screen of the device.
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.
12.7 Starting Treatment

Connect the device to a power outlet, press the Start / Stop , 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
3B MEDICAL or your physician. If you suffer from chest discomfort, shortness of breath,
18 / 48
stomach bloating, or severe headache when using the device, contact your
physician or qualified medical personnel immediately.
13. Routine Use

13.1 Connecting the Tubing
Connect the power cord, power adapter, and tubing properly according to the
instructions in the First Time Setup (Chapter 12). Connect the mask and headgear
according to the user manual for the mask.
CAUTION!
• Before each use, examine the tubing for any damage or debris. If necessary,
clean the tubing to remove the debris. Replace any damaged tubing. Make sure
that the mask does not leak.
13.2 Adjusting the Tubing

Lie down on your bed, and adjust the tubing 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.
13.3 Turning on the Airflow

Press the Start / Stop Button to turn on the airflow. The screen will display
treatment pressure and other information.
13.4 Heating the Water

Pay attention to the number next to the icon when using the humidifier. The
number indicate the On / Off state of the humidifier. It is off when the number next
to the icon is 0.
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.
13.5 Using the Ramp Feature

Every time the feature is enabled, 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 use the ramp feature as often as you wish during sleep.
• The ramp feature is not prescribed for all users.
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13.6 Accessing the iCode

After the device is powered on, move the cursor to the icon by turning the
Knob , as shown in the Fig. 13-1. Access the iCode information by pressing the
Knob , the screen displays the iCode Inerface, as shown in the Fig. 13-2.
Fig. 13-1
Fig. 13-2
13.7 Turning the Device Off

Take off the mask and headgear, press the Start / Stop Button , 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.
14. 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.
14.1 Filling the Water Chamber

14.1.1 Removing the Water Chamber
Press down the water chamber, and then remove it, as shown in Fig. 14-1.
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Fig. 14-1
WARNING!
• Turn the device off and allow approximately 15 minutes for the heater plate and
water to cool.
14.1.2 Filling Water

(1) Open the cap, as shown in Fig. 14-2, and fill the water chamber with
approximately 360 mL of water, as shown in Fig. 14-3. Make sure that the water does
not exceed the maximum water level line.
Fig. 14-2
Fig. 14-3
(2) Open the cap, and fill the water chamber with approximately 360 ml of water,
as shown in Fig. 14-4. Make sure that the water does not exceed the maximum
water level line.
21 / 48
Fig. 14-4
WARNING!
• Change water before every use and do not surpass the maximum water level line.
CAUTIONS!
• Empty the water chamber when the heated humidifier is not in use.
• Distilled water is recommended.
IMPORTANT TIP!
• It is not necessary that remove the water chamber from the device. The users can
open the cap of the water chamber directly to fill the water.
14.1.3 Returning the Water Chamber

Close the cap after it is filled with water, as shown in Fig. 14-5, and return it to the
device, as shown in Fig. 14-6.
Fig. 14-5
Fig. 14-6
22 / 48
WARNING!
• For safety purposes, the device must be placed on a flat surface at a level lower
than the patient's head on a bed, so that the condensation flows back to the water
chamber rather than remain in the tubing causing rainout.
CAUTIONS!
• Avoid moving or tilting the device when the water chamber has water in it.
• Take precautions to protect furniture from water damage.
14.2 Emptying the Water Chamber

(1) Removing the water chamber according to instructions in 14.1.1.
(2) Emptying the water chamber: Open the cap, as shown below, and pour any
remaining water out of the water chamber.
Fig. 14-7
CAUTION!
• Empty and air-dry the water chamber when the device is not in use.
(3) Returning the Water Chamber according to instructions in 14.1.3.
14.3 Setting the Humidity Level

After the device is powered on, turn the Knob to turn on or turn off the heated
humidifier and to adjust the humidity level according to instructions of the Patient
Menu of the device.
There are five humidity levels available, and the number of humidity level will
appear in the Main Interface on the screen of the device. The number 2 next to the
icon indicating the humidity is adjusted to Level 2, as shown in Fig. 14-8. The
temperature of the water in the water chamber maintains a constant set level.
Fig. 14-8
23 / 48
WARNING!
• Do not touch the heater plate of the device when it is working, otherwise you may
get burned. Turn off the heat when the heated humidifier is not in use.
CAUTIONS!
• Generally speaking, the humidity inside the mask is low when the water
temperature is low.
• The greater the difference between the temperature inside the air tubing and
room temperature is, the more easily condensation occurs inside the tubing.
• If there are only a few condensed water droplets inside the tubing in the morning
after therapy, it means that the humidity level is appropriate; if there is lots of
condensed water droplets inside the tubing and / or mask, it means that the
humidity level is too high and should be set lower; Nasal dryness means that the
humidity level is too low and should be set higher.
15. Using the Cellular Module

The Luna® G3 APAP / Luna® G3 CPAP with a Cellular Module can wirelessly
communicate with the iCodeConnect. The iCodeconnect is intended to augment
the standard follow-up care of patients diagnosed with obstructive sleep apnea by
displaying usage and therapeutic information that has been transmitted from the
patient's Luna® G3 APAP / Luna® G3 CPAP therapy device to the clinician or
healthcare professional.
(1) Insert the Cellular Module into the device, and turn on the device. The device
screen displays the Main Screen shown in Fig. 15-1.
Fig. 15-1
(2) The Cellular Module starts searching for signals in a few seconds. Once a signal is
found, the module will automatically connect to it, and a signal icon will appear in
the status bar at the top of the device screen.
24 / 48
There are four different signal icons, as listed in Table 2:

Table 2 Description of Signal Icons
Icon Description
Strong signal
Moderate signal
Weak signal
No signal found
Note:
(1) When the signal is weak, data transmission may become slow and even stop.
(2) The Cellular Module will keep searching for GPRS signals until one is found.
If the signal is strong, the signal icon appears in the Main Screen, as shown in Fig.
15-2 (the signal icons of different strength appear in a similar way).
Fig. 15-2
The device screen will not show the signal icon, if the Cellular Module is connected
to the device improperly or if the Module is not working properly.
WARNING!
• To ensure successful data transmission through the Cellular Module, computers,
televisions, radios or similar devices should not be placed near the Cellular Module.
16. Navigating the Patient Menu

16.1 Steps to Navigate the Patient Menu
16.1.1 Accessing the Main Interface
Connect the power cord and power adapter properly. The screen displays the Main
Interface shown in Fig. 16-1.
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Fig. 16-1
Note: The above interface only applicable to the device does not activate the
SmartC or SmartA. If the SmartC or SmartA is enabled, and the symbol will
appear in the status bar at the top of the screen, as shown in Fig. 16-2.
Fig. 16-2
The first icon on the upper part of the screen indicates the Preheat Function Icon,
the second icon indicates the Accessorie, and the third icon indicates Mask
Setup Icon, the fourth icon indicates the Report Interface Icon, the fifth icon
indicates the Initial Setup Icon. As you turn the Knob , the cursor switches among
the five icons, and the interface displayed on the screen changes accordingly.
Note: As the humidity levels is off, the Preheat Function Icon will become gray, as
shown in Fig. 16-2.
16.1.2 Bringing up the Initial Setup Interface

After the display screen displays the Main Interface shown in the Fig. 16-1, turn the
Knob . When the cursor is on the icon , press the Knob , the screen displays
the Initial Setup Interface of the Patient Menu, as shown in Fig. 16-3.
Fig. 16-3
26 / 48
Note: The Heated Tubing option can only be adjusted when the device is
connected to the heated tubing, as shown in Fig. 16-4.
Fig. 16-4
16.1.3 Selecting Options

As you turn the Knob clockwise, the cursor moves downwards from one option
to another. When the cursor is on a certain option, press the Knob , and the color
of the option is changed, meaning that the option can now be adjusted, as shown
by the Humidifier option in Fig. 16-5.
Fig. 16-5
16.1.4 Adjusting Options

Adjust the option by turning the Knob . As shown in Fig. 16-6, the Humidifier
option is selected. As you turn the Knob clockwise, the numbering increases,
indicating a higher humidity level. As you turn the Knob counterclockwise, the
numbering decreases, indicating a lower humidity level.
Fig. 16-6
27 / 48
16.1.5 Confirming Adjustments

Confirm your adjustment to an option by pressing the Knob . The option is then
displayed in white, as shown in Fig. 16-7.
Fig. 16-7
16.1.6 Turning Pages

When the cursor is on Work screen saver, the last option shown in Fig. 17-7, the
remaining options will appear on a new page if you continue to turn the Knob
clockwise, as shown in Fig. 16-8.
Fig. 16-8
Note: are page turning symbols.
16.1.7 Exiting the Patient Menu

The users can press the Home to return to the Main Interface shown in Fig.
16-1.
28 / 48
16.2 Options of the Patient Menu and Corresponding

Descriptions
Option Range Description
There are five humidity levels available. As the
Off, Auto, numbering increases, the humidity rises
Humidifier
1 ～ 5 accordingly. “Off” means the humidifier is
turned off.
Set humidifier to preheat by adjusting this
Preheat On / Off option. This feature automatically turns off after
30 minutes.
This feature enables the device to
automatically reduce the treatment pressure
when the patient exhales, so as to make the
Reslex Off, 1 ～ 3
user more comfortable. The higher the
numbering is, the more pressure the device
reduces. “Off” means this feature is disabled.
There are five heat levels available. As the
numbering increases, the heat rises
Off, Auto,
Heated Tubing accordingly. “Off” means the heat is turned off.
1 ～ 5
Note: Heated Tubing is displayed in the patient
menu only when it is connected.
In order to increase comfort and help the
patient fall asleep easily, the pressure can
increase gradually, when the Ramp feature is
enabled. The ramp time during which the initial
Auto, 0 - pressure rises to the prescribed treatment
Ramp Time
Max Ramp pressure can be adjusted. As you turn the Knob
to the nearest point, the numbering
increases or decreases by five seconds. The
screen displays a real-time countdown of the
remaining ramp time in seconds.
When the humidifier is on, this feature allows the
airflow to continue for about 15 minutes at a
low pressure (about 2 hPa) after you press the
Start / Stop to discontinue treatment. This
Delay On / Off will blow off the vapor left in the water chamber
to avoid any damage to the device. When this
feature is set to “Off”, which means it is
disabled, the airfolw stops delivering air instantly
after you press the Start / Stop .
2000-01-01
Date — Set date by adjusting this option.
2099-12-31
yy mm dd /
Turn the Knob to choose among three date
Date Format mm dd yy /
formats.
dd mm yy
29 / 48
00:00
Time — Set time by adjusting this option.
23:59
12-hour / Turn the Knob to choose between the two
Time Format
24-hour time formats.
Setting screen brightness by adjusting this

Brightness High / Low
option.
The backlight of the LCD screen can be set to
“Auto” or “On”. Turn the Knob to choose
between the two modes. If it is set to “Auto”,
Backlight Auto / On
the backlight will turn off automatically after 30
seconds of inactivity. If it is set to “On”, the
backlight will always be on.
There are three mask types available, Full Face
(full-face mask), Nasal (nasal mask), and Pillow
(nasal pillow mask). The default mask type is
Full Face;
“Nasal”, but the patient can choose other
Mask Type Nasal;
suitable masks as well. When the user select
Pillow; Other
masks other than the above three types of 3B
MEDICAL masks, the patient can identify the
masks as other.
Test whether the mask is worn correctly,the
Start the
Mask Fititing screen will display the “great” icon if it is
Mask Fititing
Test qualified, otherwise the screen will display the
Test
“need to adjust” icon.
iCode provides access to the patient's
iCode, compliance data during a recent time period.
iCode iCode QR, The iCode mode displays data in sequences of
iCode QR + numbers, and the iCode QR / iCode QR +
mode displays data in two-dimensional codes.
Use Time displays how long has the device
Use Time 0 ～ 50000 h been used by the patient. The use time can be
erased.
Consumables
—— Reset the use time of the filter, tubing and mask.
Alert
30 days/60 This function is used for setting filter reminder,
Consumables days/180 tube reminder and mask reminder. After
Reminder days/365 opening, can set the use time of filter, tube and
days /Off mask.
Language English The default setting is “English”.
Displays related information of the device
About —— (Model, SN, Version, ID). This is read-only and
cannot be edited.
30 / 48
17. Alert
Alert Message Description
An audible alert will sound in 6 s if the device is accidentally
disconnected from power when it is delivering air.
Note:
Power Failure!!!
(1) The alert will not sound if power failure occurs when the
device is in standby state.
(2) No alert message on the screen during a power failure.
An audible alert will sound if no airflow comes out of the
Device Fault!!!
machine; the screen will display “Device Fault!!!”.
When the airflow is on, an audible alert will sound if the air
Leak!!
leak rate is excessive; the screen will display “Leak!!”.
If the voltage supplied by power adaptor is lower than 22V,
Low Input
an audible alert will sound and the screen will display “Low
Voltage!!
Input Voltage!!”.
When humidifier is applied, an audible alert will sound when
Humidifier
the humidifier fails to work; the screen will display “Humidifier
Failure!!
Failure!!”.
When the Filter reminder feature is enabled, an audible alert
Please Change will sound if the preset replacement time reaches but without
Filter! replacing the air filter; the screen will display “Please Change
Filter!”.
When the tubing reminder feature is enabled, an audible
Please Change alert will sound if the preset replacement time reaches but
Tube! without replacing the tubing; the screen will display “Please
Change Tube!”.
When the Mask reminder feature is enabled, an audible alert
Please Change will sound if the preset replacement time reaches but without
Mask! replacing the mask; the screen will display “Please Change
Mask!”.
The screen will display “SD Card Full!” if the SD card has
SD Card Full!
reached its maximum capacity.
The screen will display “Reinsert SD card!” if the SD card fails
Reinsert SD card!
to work.
31 / 48
18. Cleaning
WARNINGS!
• Regular cleaning of the device and its accessories is very important for the
prevention of respiratory infections.
• To avoid electric shock, always unplug the device before cleaning.
• Use mild soap that is nontoxic to humans.
• Follow the manufacturer's instructions on cleaning the mask and tubing and on
determining the frequency of cleaning.
• Before cleaning, check whether the device has been disconnected from the
power supply, whether the power cord has been unplugged, and whether the
water chamber of the device has cooled down. Make sure the plate has cooled
down to room temperature, to avoid the risk of burns.
• Do not open or modify the device. There are no user serviceable parts inside.
Repairs and servicing should only be performed by an authorized service agent.
CAUTIONS!
• Overheating of the materials could lead to early fatigue of these materials.
• Do not use solutions containing chlorinated lime, chlorine, or aromatic to clean
the device and its accessories. Liquid soap containing moisturizing agents or
antimicrobials should not be used either. These solutions may harden cleaned
materials or reduce their lifespan.
• Do not clean or dry the device and its accessories when the temperature is higher
than 80°C (176°F). High temperatures could reduce product life.
• Do not immerse the device in any fluids.
18.1 Cleaning the Water Chamber

(1) Opening the Water Chamber: Open the cap of the water chamber, as shown in
Fig. 18-1.
Fig. 18-1
(2) Cleaning the Water Chamber: You may also clean the water chamber with a
soft cloth which does not scratch the water chamber (dip the soft cloth in liquid
soap if necessary), rinse it thoroughly, and then wipe it dry with a soft cloth.
(3) Returning the Water Chamber according to instructions in 14.1.3.
32 / 48
WARNINGS!
• Emptying and cleaning the water chamber daily will help prevent mold and
bacteria growth.
• Allow the water in the chamber to cool down to room temperature before
removing it from the device.
CAUTIONS!
• Clean the water chamber only after the water in it cools. Make sure that no water
enters the device.
• After cleaning, rinse the water chamber throughly in clean water to make sure
that no soap residue is left; then wipe it dry with a lint-free cloth, so as to prevent
calcareous accumulations.
• Inspect the water chamber for any leak or damage. Replace the water chamber
if any damage is present.
• It is recommended to clean the water chamber and change the water daily.
18.2 Cleaning the Transfer Box

(1) Removing the Transfer Box: First remove the water chamber from the device,
and then remove the transfer box, as shown in Fig. 18-2.
Transfer Box
Fig. 18-2
(2) Cleaning the Transfer Box: Rinse the transfer box throughly in clean water. You
may also clean the transfer box with a soft cloth which does not scratch it (dip the
soft cloth in liquid soap if necessary), rinse it thoroughly, and then wipe it dry with a
soft cloth.
(3) Returning the Transfer Box: As shown in Fig. 18-3.
Transfer Box
Fig. 18-3
CAUTION!
• It is recommended to clean the transfer box once a week.
33 / 48
18.3 Cleaning the Mask and Headgear

For details, refer to the cleaning instructions in the user manual for the mask.
18.4 Cleaning the Enclosure

Wipe the surface of the device with a soft, slightly damp cloth.
CAUTIONS!
• The device can only be used after the enclosure is dry, so that no moisture enters
the device.
• It is recommended to clean the enclosure once a week.
18.5 Cleaning the Tubing

(1) Remove the tubing from the device and mask before cleaning.
(2) Hold the cuff of the tubing and gently pull it away from the device as shown in
Fig. 18-4. Or disconnect the power of the heated tubing, then hold the cuff of the
heated tubing and pull it away from the device, as shown in Fig. 18-5.
Fig. 18-4
Fig. 18-5
(3) Hold both the cuff of the air tubing and the swivel of the mask, then gently pull
apart as shown in Fig. 18-6.
Fig. 18-6
34 / 48
(4) Clean the components with a soft bristled brush for one minute while soaking in
detergent solution (see the table below). Pay particular attention to all crevices and
cavities.
Heated
Detergent Water temperature Tubing
Tubing
AlconoxTM Warm water
√ √
(diluted at 1%) (approx 113 to 140°F or 45 to 60°C)
(5) Run the detergent solution through the air tubing repeatedly until no
contamination is visible.
(6) Thoroughly rinse each component according to the detergent manufacturer's
instructions.
(7) Thoroughly rinse the tubing in drinking quality water (five liters per assembly) by
immersing it completely for a minimum of one minute in duration.
(8) Repeat the rinse procedure two additional times using fresh water for a total of
three rinses.
(9) Air dry out of direct sunlight and/or heat.
(10) Inspecting
Perform a visual inspection of the components. If any visible deterioration is
apparent (holes, tears or cracks etc.), the components should be discarded and
replaced. Slight discoloration may occur and is acceptable.
WARNINGS!
• Please wash by hand.
•The tubing should be cleaned daily.
• If the heated tubing is damaged (such as broken hole, tear, exposed heated wire,
etc.) or poor function, please do not repair and use it by yourself and replace it
immediately.
• Failure to clean in accordance with the Manual may result in reduced
performance of the heated tubing or reduced product life.
• After cleaning and prior to reuse, the Breathing Tubing should be inspected for
holes, creases and tears.
18.6 Replacing the Air Filter / PM2.5 Filter

(1) Open the air filter cap to remove the air filter. Attach a new air filter to the filter
cap, as shown in Fig. 18-7.
Air Filter Filter Cap
Fig. 18-7
35 / 48
(2) Install the filter cap containing the air filter to the device, as shown in Fig. 18-8.
Fig. 18-8
(3) Disassemble the PM2.5 Filter from the device, as shown in Fig. 18-9, then change
a new one.
PM2.5 Filter
Fig. 18-9
CAUTIONS!
• To avoid material damage, do not place the spare air filter / PM2.5 Filter in direct
sunlight, humid environments, or temperatures below the freezing point. The air filter
/ PM2.5 Filter should be replaced every 6 months (It may be replaced more
frequently based on actual sanitary conditions).
• Operating the device with a dirty air filter may stop it from working properly and
may cause damage to the device.
19. Traveling with the Device

(1) Use the 3B MEDICAL carrying case to carry the device and accessories along
with you. Do not put them in your checked baggage.
(2) This device operates on power supplies of 100 - 240 V and 50 / 60 Hz, and is
suitable for use in any country in the world. No special adjustment is necessary, but
you will need to find out the types of the power sockets in your destination. Bring, if
necessary, a power socket adaptor which can be purchased in electronics stores.
(3) Remember to bring a spare air filter and the emergency documents (filled and
signed by your physician) about this device. If you plan to travel by air, remember to
bring the multi-language emergency documents about respiratory therapy, in case
that the border and customs officers in your destination country inspect the device.
With the emergency documents, you can prove to them that it is a medical device.
36 / 48
(4) Security Stations: For convenience at security stations, there is a note on the
bottom of the device stating that it is medical equipment. It may be helpful to bring
this manual along with you to help security personnel understand the device.
CAUTIONS!
• Empty the water chamber before packing the device for your trip; in order to
prevent any remaining water from entering the device.
• Using the device at an incorrect elevation setting could result in airflow pressures
higher than the prescribed setting. Always verify the elevation setting when
traveling or relocating.
• If the device is used when the atmospheric pressure is out of the stated range (See
Section 6), the accuracy of the leakage alert will be affected.
20. Transferring the Device to Another Patient

If the device is transferred to another patient, components in close contact with the
previous user, including the mask, headgear, tubing, and air filter, should be
replaced to prevent cross-infection.
21. Reordering
Contact your home care provider to order accessories or replacement filters.
The device does not require routine servicing.
WARNINGS!
• If you notice any unexplained changes in the performance of the device, if it is
making unusual or harsh sounds, if it has been dropped or mishandled, if the
enclosure is broken, or if water has entered the enclosure, discontinue use. Contact
your home care provider.
• If the device malfunctions, contact your home care provider immediately. Never
attempt to open the enclosure of the device. Repairs and adjustments must be
performed by 3B MEDICAL -authorized service personnel only. Unauthorized service
could cause injury, invalidate the warranty, or result in costly damage.
• If necessary, contact your local authorized dealer or 3B Medical, Inc., for
technical support and documents.
22. Technical Support

Please contact 3B MEDICAL directly if you need the circuit diagram of the device
and the list of components for certain purposes such as maintenance or connection
to other equipment. 3B MEDICAL will provide the circuit diagram and / or other
technical documents in whole or in part according to your needs.
37 / 48
23. Disposal
Electrical product components contain chemical substance which may pollute
environment, when the device reaches the end of its service life, dispose of the
device and packaging in accordance with local laws and regulations.
24. Troubleshooting
The table below lists common problems you may have with the device and possible
solutions to those problems. If none of the corrective actions solve the problem,
contact your home care provider.
24.1 Common Problems in Patients and Corresponding

Solutions
Problem Possible Cause Solution(s)
The nose reacts to the Increase the humidity setting of
airflow and cold. Due to the device.
Dry, cold, runny,
fast airflow, the air
and blocked Contact your physician, and
becomes cold, leading to
nose; having a continue treatment unless the
nasal mucosa irritation and
cold physician suggests the
subsequent dryness and
opposite.
swelling.
Probably because the
Use a chin strap to prevent the
patient sleeps with his or
mouth from opening during
Dry mouth and her mouth open, and the
sleep, or use a full-face mask.
throat pressurized air goes out via
Contact your physician for
the mouth, leading to nasal
details.
and throat dryness.
Narrow the distance between
the forehead support of the
mask and the forehead. Note
The mask size or model may that adjusting the mask too
not be correct, or the mask tight may leave markings on
is not positioned correctly, the patient’s face.
Eye irritation thereby leading to air Contact your equipment
leakage. supplier for an appropriate
mask. Add additional filling to
the mask if necessary.
Mask cushion (the soft part Replace the mask or mask
of the mask) hardens. cushion.
The mask is too tight. Loosen the headgear.
Facial The distance between the Try a different distance. The

reddening forehead support of the angle and size of the forehead
mask and the forehead is support differ according to the
not correct. type of masks.
38 / 48

Contract your equipment
Wrong mask size.
supplier for a correct-size mask.
Contact your physician and
Facial equipment supplier.
reddening The patient is allergic to the Use a mask which is not made
materials of the mask. with natural rubber latex.
Place a lining between the skin
and mask.
Turn the humidity setting down,
or raise the room temperature.
When the humidifier is used, Place the tubing under the
the humidified air tends to quilt, or use the tubing cover.
Water in mask condense in the cold
tubing and mask if the Hang the tubing loosely, and
room temperature is low. the lowest part of the tubing
should be lower than the
patient's head.
Nasal, sinus, or Sinus or middle ear Contact your physician
ear pain inflammation. immediately.
The patient will feel
uncomfortable when the
treatment pressure is higher Patients may experience a
Discomfort due variance in time to acclimate
than 13 hPa. However, the
to inability to to their therapy.
treatment pressure is
adapt to the
determined according to If the problem persists, contact
treatment
the patient's conditions, your physician or home care
pressure
and cannot treat sleep company for assistance.
apnea if the treatment
pressure is set too low.
There are many causes of
Obstructive recurring symptoms
Contact your physician for
sleep apnea including weight change,
assistance.
symptoms recur medication or alcohol, and
poor mask fit.
The device is The tubing is not
Reconnect the tubing properly.
too noisy connected properly.
Replace the air filter (refer to
18.6 Replacing the Air Filter /
PM2.5 Filter), and clean the air
Air delivered The air inlet of the device inlet.
from the device may be partially blocked,
is abnormally leading to insufficient Place the device in an area
hot airflow into the device. where air flows freely, and
make sure the device is at least
20 centimeters away from the
wall, curtain, or other things.
39 / 48
24.2 Common Problems in the Device and Corresponding

Solutions
Take a few deep breaths with
The Auto On / Off
the mask on, and the device
feature is enabled.
will start automatically.
Ensure that the power cord,
Power is not connected power adapter, and the
properly. device are connected
The device does properly.
not work when it is Check whether a power
turned on outage occurs by turning on a
light or other means. If you are
There is no voltage.
sure the fuse in the device is
broken, contact your
equipment supplier for repair.
Contact your equipment
Cannot find any cause.
supplier.
The tubing is not
The device is Reconnect the tubing properly.
connected properly.
working, but the
There may be holes in
pressure inside the Contact your equipment
the mask or pressure
mask differs from supplier.
sensing tubing.
the set treatment
Contact your equipment
pressure It is a faulty device.
supplier.
Replace the air filter (refer to
18.6 Replacing the Air Filter /
The air inlet of the
PM2.5 Filter), and clean the air
device may be blocked.
inlet. Make sure the air inlet is
unblocked.
The treatment pressure
The device
has been changed Contact your physician.
produces very low
accidentally.
pressures
When the Ramp feature
is enabled, it takes some
If necessary, disable the Ramp
time for the initial
feature, or set the ramp time
pressure to rise to the
shorter.
treatment pressure. This
is normal.
After the device is
turned on, the
The operating system of Unplug the power cord of the
screen displays
the device needs to be device, and re-plug it 20
intermittently, or
readjusted or restarted. seconds later.
displays nothing at
all
The device is in The operating system of Unplug the power cord of the
standby, and will the device needs to be device, and re-plug it 20
not start readjusted or restarted. seconds later.
40 / 48
25. Information of QoS

The data transmission between the Luna® G3 APAP / Luna® G3 CPAP with a Cellular
Module and iCodeConnect is a daily transmission. The Cellular Module transmits the
following four types of data: Therapy summary data in a defined period of time,
compliance data, system settings, and device information.
This process is not real time communication.
The size of the data transmitted to Cellular Module per second is no more than 1k in
normal condition, and no more than 1M within 8 hours per night.
Acceptable latency
As the user information is not viewed by the doctor in real time, sometimes it can be
delayed for 24 or more hours.
Acceptable level of probability for loss of information within the network

The data has little effects on treatment effectiveness. These are key data, and their
integrity should be ensured, but they do not involve real-time control of therapeutic
medical devices, and do not rely on network quality.
Wrong transmission of the information described in sections above data will be
abandoned based on a checking mechanism, and correct data will be sent
continuously until received completely.
The data transmission protocol between the module and the server includes
unpacking information and ID value, which ensure the completeness of the data
transmission.
Signal priorities of the network

The therapy device itself does not have high-priority medical device alerts, and its
treatment of patients does not rely on wireless communications.
Based on the above analysis, the Cellular Module has low requirements for QoS.
41 / 48
26. EMC Requirements

Guidance and manufacturer's declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified
below. The user of the device should ensure that it is used in such an
environment.
Electromagnetic Environment -
Emissions Test Compliance
Guidance
The device uses RF energy only
for its internal function. Therefore
RF emissions its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any
interference in nearby electronic
equipment
RF emissions
Class B The device is suitable for use in all
CISPR 11
establishments including
Harmonic emissions domestic establishments and
Class A
IEC 61000-3-2 those directly connected to the
public low-voltage power supply
Voltage fluctuations network that supplies buildings
/ flicker emissions Complies used for domestic purposes
IEC 61000-3-3
42 / 48
Guidance and manufacturer's declaration - electromagnetic immunity

below. The user of the device should make sure that it is used in such an
environment.
IEC 60601 Test Compliance Electromagnetic
Immunity Test
Level Level Environment - Guidance
Floor should be wood,

±8 kV contact ±8 kV contact
Electrostatic concrete or ceramic tile.
discharge (ESD) If floors are covered with
±2 kV, ±4 kV, ±2 kV, ±4 kV,
synthetic material, the
±8 kV, ±15 kV ±8 kV, ±15 kV
IEC 61000-4-2 relative humidity should
air air
be at least 30%
Electrical fast Mains power quality

±2 kV for ±2 kV for
transient / burst should be that of a typical
power supply power supply
commercial or hospital
lines lines
IEC 61000-4-4 environment
Mains power quality
Surge ±1 kV ±1 kV should be that of a typical
line(s) to line(s) line(s) to line(s) commercial or hospital
IEC 61000-4-5
environment
0% UT; 0.5 0% UT; 0.5

cycle cycle
Mains power quality
At 0°, 45°, 90°, At 0°, 45°, 90°,
should be that of a typical
Voltage dips, 135°, 180°, 135°, 180°,
commercial or hospital
short 225°, 270° and 225°, 270° and
environment. If the user of
interruptions 315° 315°
the device requires
and voltage
continued operation
variations on 0% UT; 1 cycle 0% UT; 1 cycle
during power mains
power supply
interruptions, it is
input lines 70% UT; 25 / 30 70% UT; 25 / 30
recommended that the
cycle cycle
device be powered from
IEC 61000-4-11 At 0° At 0°
an uninterruptible power
supply or a battery
0% UT; 250 / 0% UT; 250 /
300 cycle 300 cycle
Power Power frequency

frequency (50 / magnetic fields should be
60 Hz) at levels characteristic of
30 A/m 30 A/m
magnetic field a typical location in a
typical commercial or
IEC 61000-4-8 hospital environment
Note: UT is the AC mains voltage prior to application of the test level.
43 / 48
Guidance and manufacturer's declaration - electromagnetic immunity

below. The user of the device should make sure that it is used in such an
environment.
Immunity IEC 60601 Test Compliance Electromagnetic Environment -
Test Level Level Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
Conducte 3V 3V part of the device, including
d RF 0.15 MHz ～ 0.15 MHz ～ cables, than the
IEC 80 MHz 80 MHz recommended separation
61000-4-6 6 V in ISM and 6 V in ISM and distance calculated from the
amateur radio amateur radio equation applicable to the
bands bands frequency of the transmitter.
between between Recommended separation
0.15 MHz and 0.15 MHz and distance
80 MHz 80 MHz d = 1.17 p
d = 0.35 p 80 MHz to 800 MHz
Radiated 10 V/m 10 V/m d = 0.70 p 800 MHz to 2.5 GHz
RF 80 MHz to 2.7 80 MHz to 2.7 Where p is the maximum output
IEC GHz GHz power rating of the transmitter
61000-4-3
in watts (W) according to the
transmitter manufacturer and d
is the recommended
separation distance in meters
(m).
Field strengths from fixed RF
transmitter, as determined by
an electromagnetic site survey,
a should be less than the
compliance level in each
frequency range. b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applied.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular /
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength
in the location in which the device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, the field strengths should be less
than 10 V/m.
44 / 48
Recommended separation distances between portable and mobile RF

communications equipment and the device
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the device
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the
maximum output power of the communications equipment.
Rated
maximum 150 kHz ～ 80 MHz 80 MHz ～ 800 MHz 800 MHz ～ 2.5 GHz
output of
transmitter d = 1.17 p d = 0.35 p d = 0.70 p
W
0.01 0.12 0.04 0.07
0.1 0.37 0.12 0.23
1 1.17 0.35 0.70
10 3.70 1.11 2.22
100 11.7 3.50 7.00
Note 1: At 80 MHz and 800 MHz, the higher frequency range applied.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where p is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
45 / 48
Recommended separation distances between RF wireless communications equipment

The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between RF wireless
communications equipment and the device as recommended below, according to
the maximum output power of the communications equipment.
Maximum
Frequency IEC 60601 Complianc Electromagnetic
Power Distance
MHz Test Level e Level Environment - Guidance
W
RF wireless
communications
equipment should be
385 1.8 0.3 27 27 used no closer to any
part of the device,
including cables, than
450 2 0.3 28 28 the recommended
separation distance
710
calculated from the
745 0.2 0.3 9 9 equation applicable to
780 the frequency of the
810 transmitter.
870 2 0.3 28 28 Recommended
930 separation distance
1720
1845 2 0.3 28 28
1970 Where p is the maximum
2450 2 0.3 28 28 output power rating of
the transmitter in watts
5240
(W) according to the
5500 transmitter manufacturer
and d is the
recommended
separation distance in
meters (m).
Field strengths from fixed
RF transmitter, as
determined by an
electromagnetic site
0.2 0.3 9 9 survey, should be less
5785 than the compliance
level in each frequency
range.
Interference may occur
in the vicinity of
equipment marked with
the following symbol:
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
46 / 48
WARNINGS!
• The device should not be used in the vicinity of other electronic equipment such
as diathermy, electrocautery and radio frequency identification (RFID), security
systems (such as electromagnetic anti-theft systems and metal detectors), cell
phone, transceiver or radio control products. If you have to do so, the device should
be observed to verify normal operation.
• Use of the device adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
• Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Luna® G3 APAP / Luna® G3 CPAP, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result.
• The device may be interfered with by other equipment, even if that other
equipment complies with CISPR EMISSION requirements.
• The device may be interfered by the electromagnetic field of some known or
unknown radio frequency transmitters in the environment during use. If interference
occurs, please stay away from the interfered electromagnetic environment, or find
and turn off the electromagnetic field interference source before continuing to use
it.
• When the device is exposed to soldering, electrosurgery, defibrillation, X-ray (γ
ray), infrared radiation, transient electromagnetic field, including nuclear magnetic
resonance (MRI) and radio interference environment, the product may be
damaged.
• During operation of the device, due to electrostatic interference, the following
phenomena may occur: (1) Temporary loss of function or degradation of
performance, such as abnormal screen display, etc. The device will recover to
normal after being restarted; (2) Automatic restart of the device. These phenomena
will not affect the normal use of the device, and will not cause permanent
performance degradation or function loss of the device.
47 / 48
27. Limited Warranty

3B Medical, Inc. warrants that the device shall be free from defects of workmanship
and materials and will perform in accordance with the product specifications for a
period of one (1) year for main device and three (3) months for all accessories from
the date of sale by BMC Medical Co., Ltd. to the dealer. If the product fails to
perform in accordance with the product specifications, 3B Medical, Inc. will repair
or replace, at its option, the defective material or part. 3B Medical, Inc. will pay
customary freight charges from 3B Medical, Inc. to the dealer location only. This
warranty does not cover damage caused by accident, misuse, abuse, alteration
and other defects not related to material or workmanship.
3B MEDICAL, Inc. DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS, LOSS OF PROFITS,
OVERHEAD OR CONSEQUENTIAL DAMAGES WHICH MAY BE CLAIMED TO ARISE
FROM ANY SALE OR USE OF THIS PRODUCT. SOME STATES DO NOT ALLOW THE
EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE
ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.
To exercise the rights under this warranty, contact the local authorized dealers or:
3B Medical, Inc.
203 Avenue A NW, Suite 300,
Winter Haven, FL 33881
T: (863) 226-6285
F: (863) 226-6284
For additional information, please visit our Patient Portal at:

www.3Bproducts.com
icodeconnect.com – Web-based cloud for report generation and storage
BMC Medical Co., Ltd.

Room 901, Building 1, No.28 Pingguoyuan Road, Shijingshan, Beijing 100041,
CHINA
Tel: +86-10-51663880
Fax: +86-10-51663880 Ext. 810
URL: en.bmc-medical.com
E-mail: intl@bmc-medical.com
Contract Manufacturer:
BMC (Tianjin) Medical Co., Ltd.
2/F North Area and 3/F, Building No.4, No.1 Xinxing Road, Wuqing District, (301700)
Tianjin, P.R.China
Tel: +86-22-82939881
Issue date: April 6, 2021
48 / 48

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User Manual

Luna® G3 APAP / Luna® G3 CPAP

Item No: LG3600 / LG3500

14.2 Emptying the Water Chamber ··················································· 23

Start / Stop Button

2.2 Device Symbols

Follow Instructions for Use

Type BF Applied Part (mask)

Class II (Double Insulated)

/ For indoor use only

IP22 ≥ 12.5 mm Diameter, Dripping (15º tilted)

Serial Number of the Product

Do not use the product if the package is damaged

Maximum water level

Product is intended for use by a single patient only

Indicates the possibility of injury to the user or operator

Logo of BMC Medical Co., Ltd.

Logo of 3B Medical, Inc.

3. Warning, Caution and Important Tip

• The patient is an intended operator.

Absolute Contraindications: Pneumothorax, mediastinal emphysema; cerebrospinal

Relative Contraindications: Severe coronary heart disease complicated with left

The following side effects may occur during treatment:

Product Use, Transport and Storage

Device offer to Heated Tubing Communications Port

Type of Protection Against Electric Shock

Degree of Protection Against Electric Shock

Degree of Protection Against Ingress of Water

Static Pressure Stability at 10 cmH2O

Dynamic Pressure Stability

6.5 ±0.5 ±0.5 ±0.5

Device with humidification and 22 mm Tubing or Heated Tubing.

Sound Pressure Level

Sound Power Level

Test Pressures (hPa) 4 8 12 16 20

Measured Pressure at the Patient

Average Flow at the Patient

The Form and the Dimensions of the Patient Connection Port

Frequency Bands Bands1 2, 3, 4, 5, 8, 12, 13, 20, 28

Communication Mode LTE Cat M1/ NB1

Enforced on all data channels

Encryption Base 128 encoding

Parameter Min. Max. Unit Remarks

Frequency Uplink 832 862 MHz Module transmit

Parameter Min. Max. Unit Remarks

Frequency Uplink 1710 1785 MHz Module transmit

Frequency Uplink 1850 1910 MHz Module transmit

CPAP – Delivers Continuous Positive Airway Pressure; CPAP maintains a constant

10. Package Contents

No. Articles Qty. Notes

head or neck of the patient during sleep.

11. System Features

Heated Tubing Port

Filter Cap (Air Inlet)

12. First Time Setup

Air Filter Filter Cap

12.3 Connecting to Power

12.4 Assembling the Tubing / Heated Tubing and Mask

Heated Tubing Joint