User Manual

Luna II CPAP / Luna II Auto CPAP

Model No LG2000 / Model No LG2A00

 Luna II CPAP / Luna II Auto 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 ······················································································7
8. Glossary ······································································································7
9. Model·········································································································8
10. Package Contents ·····················································································9
11. System Features ························································································10
12. First Time Setup··························································································11
12.1 Placing the Device ··········································································11
12.2 Installing the Air Filter and Filter Cap ··················································12
12.3 Connecting to Power ······································································12
12.4 Assembling the Tube and Mask·························································13
12.5 Using Oxygen with the Device ··························································14
12.6 Inserting the SD Card (Only for the device that equipped with SD card) 15
12.7 Using the Cellular Module or Wi-Fi Kit ·················································16
12.8 Starting Treatment ···········································································16
13. Routine Use ······························································································16
13.1 Connecting the Tube ······································································16
13.2 Adjusting the Tube···········································································16
13.3 Turning on the Airflow ······································································16
13.4 Heating the Water ···········································································16
13.5 Using the Ramp Button·····································································17
13.6 Turning the Device Off ·····································································17
14. Heated Humidifier ·····················································································17
14.1 Filling the Water Chamber ································································17
14.1.1 Removing the Water Chamber ··············································17
14.1.2 Filling Water ·········································································18
14.1.3 Inserting the Water Chamber ·················································18
14.2 Emptying the Water Chamber ··························································19
14.3 Setting the Humidity Level ································································20
15. Navigating the Patient Menu······································································21
15.1 Steps to Navigating the Patient Menu ···············································21
15.1.1 Accessing the Main Interface ················································21
15.1.2 Bringing up the Initial Setup Interface ·····································21
15.1.3 Accessing the Setup Interface ···············································22
15.1.4 Selecting Options ·································································22
15.1.5 Adjusting Options ·································································22
15.1.6 Confirming Adjustments ························································23
15.1.7 Turning Pages ······································································23
15.1.8 Exiting the Patient Menu ························································23
15.2 Options of the Patient Menu and Corresponding Descriptions··············25
16. Alert·········································································································26
17. Cleaning ··································································································27
17.1 Cleaning the Mask and Headgear ····················································27
17.2 Cleaning the Cellular Module and Wi-Fi kit ·········································27
 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

17.3 Cleaning the Water Chamber ··························································28

17.4 Cleaning the Enclosure ····································································28
17.5 Cleaning the Tube···········································································29
17.6 Replacing the Air Filter ·····································································29
18. Traveling with the Device ···········································································29
19. Reordering ·······························································································30
20. Technical Support ·····················································································30
21. Disposal ···································································································30
22. Troubleshooting ························································································31
22.1 Common Problems in Patients and Corresponding Solutions ················31
22.2 Common Problems in the Device and Corresponding Solutions ···········33
23. EMC Requirements ····················································································34
24. Limited Warranty ·······················································································40
 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

1. Introduction
Thank you for your purchase of the Luna II CPAP / Luna II Auto 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

Ramp Button

Mute Button

Knob

2.2 Device Symbols

Follow Instructions for Use

Operating Instructions

Type BF Applied Part (mask)

Class II (Double Insulated)

AC Power

DC Power

IP22 ≥12.5 mm Diameter, Dripping (15ºtilted)

Hot Surface

Serial Number of the Product

Manufacturer

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

EC REP
Authorized Representative in the European Community

Disassembly is prohibited

European CE Declaration of Conformity

Lot number

Non-Ionizing Radiation

SD Card

WEEE Marking

Air Inlet

Air Outlet

Logo of BMC Medical Co., Ltd.

Logo of 3B Medical, Inc.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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 II CPAP and Luna II Auto CPAP are intended to deliver positive pressure for
the treatment of obstructive sleep apnea. The optional integrated heated
humidifier is indicated for the humidification and warming of air from the flow
generator. These devices are intended for single patient use by prescription in the
home or hospital/institutional environment on adult patients.

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.
• 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!
• Federal law restricts this device to sale by or on the order of a physician.
• The device is intended for use by operators trained or experienced in similar
equipment.
• The patient is an intended operator.
• Cleaning can be performed by the patient.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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.

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

IMPORTANTS!
• 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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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

6. Specifications
Device Size
Dimensions: 274 mm × 184 mm × 115 mm
Weight: 1.9 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 cmH2O 760 ～ 1060 cmH2O

Heated Humidifier
Humidifier Settings: off, 1 to 5 (95˚F to 154.4˚F / 35°C to 68°C)
Humidifier Output: No less than 10 mg H2O/L
Environmental Conditions: Maximum airflow, 35°C, 15% relative humidity

Mode of Operation
Continuous

Work Mode
For LG2000: CPAP
For LG2A00: CPAP, Auto

SD Card
The SD card can record patient data and fault information

AC Power Consumption
100 - 240 V ～, 50 / 60 Hz, Max 2 A

Device offer to USB Communications Port

5V 2.0 A

Type of Protection Against Electric Shock

Class II Equipment

Degree of Protection Against Electric Shock

Type BF Applied Part

Degree of Protection Against Ingress of Water

IP22

Pressure Range
4 to 20 cmH2O (in 0.5 cmH2O increments), ≤30 cmH2O under single fault conditions.

Static Pressure Stability

±0.5 cmH2O

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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 cmH2O.

Sound Power Level

< 38 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

3 9 14 19
Connection Port (cmH2O)

Average Flow at the Patient

85 135 140 140
Connection Port (L/min)

Automatic leak compensation

The pressure error ≤ ± 1 cmH2O when the air leakage is no more than 70 L / min.

Pressure
Range: 0 ～ 20 cmH2O
Margin of Error: ± (0.4 cmH2O + 4%)

Tube
Length: 6 ft. (1.83 m)
Maximum Delivered Gas Temperature
≤ 43°C
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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. If your health care professional has
prescribed ramp for you, you can press the Ramp Button to reduce the pressure
and then gradually increase the pressure to the therapeutic pressure setting so that
you can fall asleep more comfortably.

Auto – 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.

Auto
Adjust CPAP pressure automatically to improve patient comfort based on
monitoring of apnea and snoring events.

Auto Off
When this feature is enabled, the device automatically discontinues therapy
whenever the mask is removed.

Auto On
With this feature, the device automatically initiates therapy when you breathe into
the mask.

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.

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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. Model
Product Description
Maximum
Model Product Work
Optional Accessory Work Mode
Contents Pressure
(cmH2O)

Device CPAP,
LG2A00
(3.5-inch TFT) Tube, Mask, Auto
Cellular Module, 20
Device Wi-Fi Kit
LG2000 CPAP
(2.4-inch TFT)

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

10. Package Contents

After unpacking the system, make sure you have everything shown here (Different
models of the product may contain different components):

No. Articles Qty.

1 Device 1
2 Air Filter 2
3 Power Adapter 1
4 Power Cord 1
5 Tube 1
6 SD Card 1
7 Carrying Case 1
8 Enclosed Documents 1

All parts and accessories are not made with natural rubber latex.

The product’s service life is five years if the use, maintenance, cleaning and
disinfection are in strict accordance with the User Manual. If the key components
are replaced, the service life may be prolonged.

IMPORTANTS!
• If any of the above parts are missing, contact your home care provider.
• Contact your home care provider for additional information on the available
accessories of this device. When using optional accessories, always follow the
instructions enclosed with the accessories.
WARNINGS!
• This device should only be used with the mask and accessories manufactured or
recommended by 3B Medical, Inc. or with those recommended by your prescribing
physician. The use of inappropriate masks and accessories may affect the
performance of the device and impair the effectiveness of therapy.
• The use of accessories other than those specified, with the exception of cables
sold by the manufacturer of the equipment or system as replacement parts for
internal components, may result in increased emissions or decreased immunity of
the equipment or system.
• Do not pile up the long tubing at the head of the bed, as it may wrap around the
head or neck of the patient during sleep.
• Do not connect any equipment to the device unless recommended by 3B
Medical, Inc. or your health care provider.
• Please contact 3B Medical, Inc. to obtain an SD card if needed.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

11. System Features

Humidifier Indicator Display Screen
Mute Button
Power Indicator
Knob
Ramp Button

Fig. 11-1

Name Function
Indicate the humidity level. There are five levels in total.
The number of indicator lights that light up is directly
Humidifier Indicator
proportional to the humidity level. If the indicator lights
are off, it means the humidifier is turned off
Press this button to mute the alert. However, if the
Mute Button problem causing the alert is not solved, the alert will
sound again two minutes later
Knob Start treatment and adjust device settings
Ramp Button Enable the Ramp feature
Display menus for operation, messages, monitoring
Display Screen
data, etc.
Power Indicator Indicate the power supply status

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SD Card Slot

Air Outlet Communications Port

DC Inlet

Filter Cap (Air Inlet)

Fig. 11-2

Name Function
SD Card Slot Insert the SD card into this slot
Air Outlet Deliver pressurized air; connects to the tube
Communications Connected to external equipment (Not for connection to
Port un-recommended devices)
DC Inlet An inlet for the DC power supply
Place the cap on the air filter, which is used to filter dust and
Filter Cap (Air Inlet)
pollen in the air entering the device

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!
• 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.

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• 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

(1) Attach the air filter to the filter cap, as shown in Fig. 12-1.

Air Filter Filter Cap

Fig. 12-1

(2) Install the filter cap containing the air filter to the device, as shown in Fig. 12-2.

Fig. 12-2

CAUTIONS!
• The air filter must be in place when the device is operating.
• Installing the air filter and filter cap, device must be unplugged.

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.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

DC Inlet

Power Adapter

Power Cord

Fig. 12-3

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.

CAUTION!
• Inspect the power cord often for any signs of damage. Replace a damaged cord
immediately.

IMPORTANTS!
• 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 Tube and Mask

(1) Connect one end of the tube to the air outlet of the device, as shown in Fig.
12-4.

Air Outlet

Tube

Fig. 12-4

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(2) Connect the other end of the tube to the mask according to the user manual for
the mask.

WARNINGS!
• If you are using a mask with a built-in exhalation port, connect the mask’s
connector to the tube.
• If you are using a mask with a separate exhalation port, connect the tube to the
exhalation port. Position the exhalation port so that the vented air is blowing away
from your face. Connect the mask’s connector to the exhalation port.
• If you are using a full-face mask (a mask covering both your mouth and nose), the
mask must be equipped with a safety (entrainment) valve.
• In order to minimize the risk of CO2 rebreathing, the patient should observe the
following instructions:
- Use the accompanying tube and mask provided by 3B Medical, Inc.
- 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
from heat, open flames, any oily substances, or other sources of ignition. DO NOT
smoke in the area near your Luna GII 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.

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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. 12-5.

SD Card Slot

Fig. 12-5
If the SD card is inserted correctly, a symbol indicating correct insertion will appear
in the Main Interface on the screen of the device, as shown in Fig. 12-6.

Fig. 12-6

If the SD card is inserted incorrectly, a symbol indicating incorrect insertion will

appear in the Main Interface on the screen of the device, as shown in Fig. 12-7.

Fig. 12-7

CAUTION!
• If the SD card is not inserted, there will not be a symbol 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.

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12.7 Using the Cellular Module or Wi-Fi Kit

For more details, please refer to the corresponding user manual.

12.8 Starting Treatment

Connect the device to a power outlet, press the Knob , 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, Inc. or your physician. If you suffer from chest discomfort, shortness of
breath, stomach bloating, or severe headache when using the device, contract
your physician or qualified medical personnel immediately.

13. Routine Use

13.1 Connecting the Tube
Connect the power cord, power adapter, and tube 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 tube for any damage or debris. If necessary, clean
the tube to remove the debris. Replace any damaged tube. Make sure that the
mask does not leak.

13.2 Adjusting the Tube

Lie down on your bed, and adjust the tube 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 Knob to turn on the airflow. The screen will display treatment pressure
and other information.

13.4 Heating the Water

Pay attention to the humidifier indicator lights when using the humidifier. The
indicator lights indicate the On / Off state of the humidifier. It is off when all indicator
lights go out.

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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 Button

Every time the Ramp Button is pressed, 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 press the Ramp Button as often as you wish during sleep.
• The ramp feature is not prescribed for all users.

13.6 Turning the Device Off

Take off the mask and headgear, press and hold the Knob for two seconds, and
the device will stop delivering air. Disconnect the power cord from the power outlet
to power off the device.

CAUTIONS!
• Do not position the device where it is difficult to disconnect the device.
• To isolate the device from the supply mains, disconnect the plug.

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
Grab the water chamber, and pull it out of the device, as shown in the figure below.

Fig. 14-1

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WARNING!
• Turn the device off and allow approximately 15 minutes for the heater plate and
water to cool.

14.1.2 Filling Water

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

WARNING!
• Change water before every use and do not surpass the MAX fill line.

CAUTIONS!
• Empty the water chamber when the heated humidifier is not in use.
• Distilled water is recommended.

14.1.3 Inserting the Water Chamber

Close the cap after it is filled with water, as shown in Fig. 14-4, and return it to the
device, as shown in Fig. 14-5.

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Fig. 14-4

Fig. 14-5

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. 14-6

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CAUTION!
• Empty and air-dry the water chamber when the device is not in use.

(3) Inserting 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 on the screen of
the device.

There are five humidity levels available, and the number of blue indicator lights that
light up is directly proportional to the humidity level. If none of the indicator lights
light up, it means that the heated humidifier is turned off.

The temperature of the water in the water chamber maintains a constant set level.
Three indicator lights light up when the humidity is adjusted to Level 3, as shown in
Fig. 14-7.

Humidifier Indicator

Fig. 14-7

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.
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.

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15. Navigating the Patient Menu

15.1 Steps to Navigating the Patient Menu
15.1.1 Accessing the Main Interface
Connect the power cord and power adapter properly. The screen displays the Main
Interface shown in Fig. 15-1(applies to LG2000), or the Main Interface shown in Fig.
15-2 (applies to LG2A00).

Fig. 15-1

Fig. 15-2

15.1.2 Bringing up the Initial Setup Interface

From the Main Interface shown in Fig. 15-1 or Fig. 15-2, press and hold the Ramp
Button for three seconds. The screen displays the Initial Setup Interface of the
Patient Menu, as shown in Fig. 15-3.

Fig. 15-3

The first icon on the left side of the screen indicates the Main Interface, the
second icon indicates the Initial Setup Interface, and the third icon indicates
the iCode Interface. As you turn the Knob , the cursor switches among the three
icons, and the interface displayed on the screen changes accordingly.

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15.1.3 Accessing the Setup Interface

When the cursor is on the icon , the screen displays the Setup Interface. Access
the Setup Interface by pressing the Knob . The first option on the Setup Interface is
then displayed in blue, as shown in Fig. 15-4.

Fig. 15-4

15.1.4 Selecting Options

As you turn the Knob clockwise, the cursor moves downwards from one option
to another. As you turn it counterclockwise, the cursor moves upwards. When the
cursor is on a certain option, press the Knob , and the option is then displayed in
yellow, meaning that the option can now be adjusted, as shown by the Humidifier
option in Fig. 15-5.

Fig. 15-5

15.1.5 Adjusting Options

Adjust the option by turning the Knob . As shown in Fig. 15-5, 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. The Humidifier option is still displayed in
yellow, as shown in Fig. 15-6.

Fig. 15-6

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15.1.6 Confirming Adjustments

Confirm your adjustment to an option by pressing the Knob . The option is then
displayed in blue, as shown in Fig. 15-7.

Fig. 15-7

15.1.7 Turning Pages

When the cursor is on Mask Type, the last option shown in Fig. 15-7, the remaining
options will appear on a new page if you continue to turn the Knob clockwise, as
shown in Fig. 15-8.

Fig. 15-8
Note: are page turning symbols.

15.1.8 Exiting the Patient Menu

(1) Returning to the Initial Setup Interface
Move the cursor to the Back option by turning the Knob , as shown in Fig. 15-9.

Fig. 15-9
Press the Knob , the cursor jumps to the second icon on the left side of the
screen. The screen displays the Initial Setup Interface, as shown in Fig. 15-10.

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Fig. 15-10
(2) Returning to the Main Interface
Move the cursor to the Home option by turning the Knob , as shown in Fig. 15-11.

Fig. 15-11
Press the Knob to exit the Patient Menu. The screen will display the Main
Interface shown in Fig. 15-1 or Fig. 15-2.

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15.2 Options of the Patient Menu and Corresponding

Descriptions
Option Range Description

There are five humidity levels available. As the

numbering increases, the humidity rises
Humidifier Off, 1 ～ 5
accordingly. “Off” means the humidifier is
turned off. The default setting is “2”

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.
The default setting is “Off”

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
pressure rises to the prescribed treatment
0 - Max
Ramp Time pressure can be adjusted. As you turn the Knob
Ramp
to the nearest point, the numbering
increases or decreases by five minutes. The
default setting is “10 minutes.” The screen
displays a real-time countdown of the
remaining ramp time in minutes

When the humidifier is on, this feature allows the

airflow to continue for about 15 minutes at a
low pressure (about 2 cmH2O) after you press
the Knob to discontinue treatment. This will
blow off the vapor left in the water chamber to
Delay On / Off
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 Knob . The default setting
is “Off”

2000-01-01
Date — Set date by adjusting this option
2099-12-31

00:00
Time — Set time by adjusting this option
23:59
Setting screen brightness by adjusting this
Brightness High / Low
option. The default setting is “High”

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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 selecting masks
Pillow; Other
other than the above three types of 3B
Medical, Inc. masks, the patient can identify
the masks as other.
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
0 ～ 50000 Use Time displays how long has the device
Use Time
h been used by the patient
Displays related information of the device
About —— (Model, SN, Version, ID). This is read-only and
cannot be edited

16. 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 in 40 s if the
Leak!!
air 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 Alert feature is enabled, an audible alert will
Please Change sound if the preset replacement time reaches but without
Filter! replacing the air filter; the screen will display “Please Change
Filter!”
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

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17. 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 tube 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, so you do not get burned.
• The device shall not be serviced or maintained while in use with a patient.
• Sterilization of this device and its components other than recommended is not
permitted.
• 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.

17.1 Cleaning the Mask and Headgear

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

17.2 Cleaning the Cellular Module and Wi-Fi kit

Wipe the surface of the Cellular Module and Wi-Fi kit with a clean, soft, and slightly
damp cloth.
CAUTION!
• It is recommended to clean the Cellular Module and Wi-Fi kit once a week.

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17.3 Cleaning the Water Chamber

(1) Opening the Water Chamber: Open the cap of the water chamber, as shown in
Fig. 17-1.

Fig. 17-1

(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.

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 do daily cleaning of the water chamber.

17.4 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.

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17.5 Cleaning the Tube

(1) Remove the tube from the device and mask before cleaning.
(2) Clean the tube in warm water which contains washing liquid, and then rinse it in
clean water thoroughly.
(3) After cleaning, air-dry the tube in a cool, well-ventilated area, and avoid direct
sunlight. It takes approximately 30 minutes to completely air-dry the tube. Check
whether the tube is completely dry before re-use.
CAUTION!
• It is recommended to clean the tube once a week.

17.6 Replacing the Air Filter

(1) Open the air filter cap to remove the air filter.
(2) Put the new air filter in the filter area, and then place the filter cap back properly.

CAUTIONS!
• To avoid material damage, do not place the spare air filter in direct sunlight,
humid environments, or temperatures below the freezing point. The air filter should
be replaced every 2 weeks (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.
• Replacing the air filter and filter cap, device must be unplugged.

18. Traveling with 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 5), the accuracy of the leakage alert will be affected.

(1) Use the 3B medical, Inc. 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

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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.
(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.

19. 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, Inc. -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.

20. Technical Support

Please contact 3B medical, Inc. 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, Inc. will provide the circuit diagram
and / or other technical documents in whole or in part according to your needs.

21. Disposal
When the device reaches the end of its service life, dispose of the device and
packaging in accordance with local laws and regulations.

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22. 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.

22.1 Common Problems in Patients and Corresponding

Solutions
Problem Possible Cause Solution(s)
The nose reacts to the
airflow and cold. Due to Increase the humidity setting of
Dry, cold, runny, the device.
fast airflow, the air
and blocked
becomes cold, leading to Contact your physician, and
nose; having a
nasal mucosa irritation and continue treatment unless the
cold
subsequent dryness and physician suggests the 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
that adjusting the mask too
The mask size or model may tight may leave markings on
not be correct, or the mask the patient’s face.
is not positioned correctly, Add additional filling to the
Eye irritation thereby leading to air mask so it does not leak.
leakage
Contact your equipment
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

The distance between the Try a different distance. The
forehead support of the angle and size of the forehead
Facial
mask and the forehead is support differ according to the
reddening
not correct type of masks
Contract your equipment
Wrong mask size
supplier for a correct-size mask

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Contact your physician and

equipment supplier.
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 tube under the quilt,
the humidified air tends to or use the tube cover.
Water in mask condense in the cold tube
and mask if the room Hang the tube loosely, and the
temperature is low lowest part of the tube 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 It takes a maximum of four
Discomfort due weeks to adapt to pressurized
than 13 cmH2O. However,
to inability to air.
the treatment pressure is
adapt to the
determined according to Relax and breathe through the
treatment
the patient's conditions, nose. If the problem still exists,
pressure
and cannot treat sleep contact your physician
apnea if the treatment
pressure is set too low
Probably because the
patient sleeps with his or Use a chin strap to prevent the
Obstructive her mouth open, and the mouth from opening during
sleep apnea pressurized air goes out via sleep, or use a full-face mask.
symptoms recur the mouth, leading to Contact your physician for
blockage in the respiratory details
tract
The device is The tube is not connected Reconnect the tube properly
too noisy properly
Replace the air filter (see 15.6
Replacing the Air Filter), and
Air delivered The air inlet of the device clean the air inlet
from the device may be partially blocked, Place the device in an area
is abnormally leading to insufficient where air flows freely, and
hot airflow into the device make sure the device is at least
20 centimeters away from the
wall, curtain, or other things

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22.2 Common Problems in the Device and Corresponding

Solutions
Problem Possible Cause Solution(s)
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 power adapter, and the
connected properly device are connected
The device does not properly
work when it is Check whether a power
turned on outage occurs by turning on
a light or other means. If you
There is no voltage
are sure the fuse in the device
is broken, contact your
equipment supplier for repair
Cannot find any Contact your equipment
cause supplier
The tube is not
The device is Reconnect the tube properly
connected properly
working, but the
There may be holes in
pressure inside the Contact your equipment
the mask or pressure
mask differs from the supplier
sensing tube
set treatment
pressure Contact your equipment
It is a faulty device
supplier
Replace the air filter (see 16.6
The air inlet of the
Replacing the Air Filter), and
device may be
clean the air inlet. Make sure
blocked
the air inlet is unblocked
The treatment
pressure has been
The device Contact your physician
changed
produces very low
accidentally
pressures
When the Ramp
feature is enabled, it
If necessary, disable the
takes some time for
Ramp feature, or set the ramp
the initial pressure to
time shorter
rise to the treatment
pressure. This is normal
After the device is The operating system Unplug the power cord of the
turned on, the of the device needs device, and re-plug it 20
screen displays to be readjusted or seconds later
intermittently, or restarted
displays nothing at
all
The operating system Unplug the power cord of the
The device is in
of the device needs device, and re-plug it 20
standby, and will not
to be readjusted or seconds later
start
restarted

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23. 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

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Guidance and manufacturer's declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified
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,

Electrostatic concrete or ceramic tile.
±8 kV contact ±8 kV contact
discharge (ESD) If floors are covered with
synthetic material, the
±15 kV air ±15 kV air
IEC 61000-4-2 relative humidity should
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.

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Guidance and manufacturer's declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified
below. The user of the device should make sure that it is used in such an
environment.
Immunity IEC 60601 Compliance Electromagnetic Environment -
Test Test Level Level Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the device, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
3V 3V Recommended separation
0.15 MHz ～ 0.15 MHz ～ distance
80 MHz 80 MHz d  1.17 p
6 V in ISM 6 V in ISM
Conducted d  0.35 p 80 MHz to 800 MHz
and and
RF
amateur amateur d  0.70 p 800 MHz to 2.5 GHz
IEC
radio bands radio bands Where P is the maximum output
61000-4-6
between between power rating of the transmitter in
0.15 MHz 0.15 MHz watts (W) according to the
and 80 MHz and 80 MHz transmitter manufacturer and d is
Radiated RF
IEC the recommended separation
61000-4-3 distance in meters (m).
10 V/m 10 V/m Field strengths from fixed RF
80 MHz to 80 MHz to 2.7 transmitter, as determined by an
2.7 GHz GHz 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.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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 150 kHz ～ 80 MHz 80 MHz ～ 800 MHz 800 MHz ～ 2.5 GHz
maximum
d  1.17 p d  0.35 p d  0.70 p
output of
transmitter
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.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

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 Electromagnetic
Frequency IEC 60601 Compliance
Power Distance Environment -
MHz Test Level Level
W Guidance
385 1.8 0.3 27 27 RF wireless
450 2 0.3 28 28 communications
equipment should be
710 used no closer to any
745 0.2 0.3 9 9 part of the device,
780 including cables,
than the
810
recommended
870 2 0.3 28 28 separation distance
930 calculated from the
1720 equation applicable
to the frequency of
1845 2 0.3 28 28 the transmitter.
1970 Recommended
2450 2 0.3 28 28 separation distance
5240
5500
Where P is the
maximum output
power rating of the
transmitter in watts
(W) according to the
transmitter
manufacturer and d
is the recommended
separation distance
in meters (m).
Field strengths from
0.2 0.3 9 9 fixed RF transmitter,
5785 as determined by an
electromagnetic site
survey, should be less
than the compliance
level in each
frequency range.
Interference may
occur in the vicinity
of equipment
marked with the
following symbol:

Note 1: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures, objects and
people.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

WARNINGS!
• This device should not be used in the vicinity or on the top of other electronic
equipment such as cell phone, transceiver or radio control products. If you have to
do so, the device should be observed to verify normal operation.

• The use of accessories and power cord other than those specified, with the
exception of cables sold by the manufacturer of the equipment or system as
replacement parts for internal components, may result in increased emissions or
decreased immunity of the equipment or system.

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 Luna II CPAP / Luna II Auto CPAP User Manual V1.0

24. 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 two (2) years for main unit and three (3) months for all accessories from the
date of sale by 3B medical, Inc. 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 Ave A NW, Suite 300
Winter Haven, FL 33884
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

Issue date: July 20, 2018

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