3B G3 Series Manual de usuario

User Manual

G3 B25A

Luna G3 BPAP 25A

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

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 
Using the Cellular Module···········································································25 
Navigating the Patient Menu······································································26 
1 Steps to Navigating the Patient Menu ···············································26 
1.1 Accessing the Main Interface ················································26 
1.2 Bringing up the Initial Setup Interface ·····································28 
1.3 Selecting Options ·································································28 
1.4 Adjusting Options ·································································29 
1.5 Confirming Adjustments ························································29 
1.6 Turning Pages ······································································29 
1.7 Exiting the Patient Menu························································ 30 
2 Options of the Patient Menu and Corresponding Descriptions··············30 
Alert·········································································································32 
Cleaning ·································································································· 33 
1 Cleaning the Mask and Headgear····················································33 
2 Cleaning the Water Chamber ··························································33 
3 Cleaning the Transfer Box·································································34 
4 Cleaning the Enclosure····································································35 
5 Cleaning the Tubing ········································································35 
6 Replacing the Air Filter / PM2.5 Filter ··················································35 
Traveling with the Device ···········································································36 
Transferring the Device to Another Patient ··················································· 37 
Reordering ·······························································································37 
Technical Support ·····················································································37 
Disposal ···································································································37 
Troubleshooting ························································································ 38 
1 Common Problems in Patients and Corresponding Solutions················38 
2 Common Problems in the Device and Corresponding Solutions ···········40 
Information of QoS ····················································································41 
EMC Requirements····················································································42 
Limited Warranty······················································································· 48 
 

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0

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1. Introduction

Thank you for your purchase of the Luna BPAP. This User Manual will introduce you to

your device. Please read it carefully. If you experience any difficulties or problems

during use, please contact your homecare provider or physician.

2. Symbols

2.1 Control Buttons

Home Button

Start / Stop Button

Knob

2.2 Device Symbols

Follow Instructions for Use

Operating Instructions

Type BF Applied Part (mask)

Class II (Double Insulated)

For indoor use only

AC Power

DC Power

IP22

≥ 12.5 mm Diameter, Dripping (15º tilted)

Electric shock hazard

Hot Surface

Product Serial Number

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0

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Manufacturer

EC REP

Authorized Representative in the European Community

Do not use the product if the package is damaged

Disassembly is prohibited

Maximum water level

European CE Declaration of Conformity

Product is intended for use by a single patient only

Lot number

Non-Ionizing Radiation

SD Card

WEEE Marking

Air Inlet

Air Outlet

Indicates the possibility of injury to the user or operator

Company logo

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3. Warning, Caution and Important Tip

WARNING!

Indicates the possibility of injury to the user or operator.

CAUTION!

Indicates the possibility of damage to the device.

IMPORTANT TIP!

Places emphasis on an operating characteristic.

Warnings, Cautions, and Important Tips appear throughout this manual as they

apply.

4. Intended Use

The Luna G3 BPAP 25A is a Bi-level PAP (Bi-level Positive Airway Pressure) device

designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated

humidifier is indicated for the humidification and warming of air from the flow

generator device. These devices are intended for single-patient use by prescription

in the home or hospital/institutional environment on adult patients. It is to be used on

patients >66 lbs./30 kg for whom CPAP therapy has been prescribed. The system

can deliver bi-level therapy or auto bi-level therapy.

WARNINGS!

• This device is intended for adult use only.

• This device is not intended for life support.

• The instructions in this manual are not intended to supersede established medical

protocols.

• To ensure that you receive the safe, effective therapy prescribed for you, use only

3B MEDICAL accessories.

• Do not bring the device or accessories into a Magnetic Resonance (MR)

environment as it may cause unacceptable risk to the patient or damage to the

device or MR medical devices. The device and accessories have not been

evaluated for safety in an MR environment.

• Do not use the device or accessories in an environment with electromagnetic

equipment such as CT scanners, Diathermy, RFID and electromagnetic security

systems (metal detectors) as it may cause unacceptable risk to the patient or

damage to the device. Some electromagnetic sources may not be apparent, if you

notice any unexplained changes in the performance of this device, if it is making

unusual or harsh sounds, disconnect the power cord and discontinue use. Contact

your home care provider.

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CAUTIONS!

•U. S. federal law restricts this device to sale by or on the order of a physician.

• The patient is the intended operator.

• The device is intended for use by operators trained or experienced in similar

equipment.

• Cleaning and disinfection can be performed by the patient.

IMPORTANT TIP!

• Read and understand the entire user manual before operating this system. If you have any

questions concerning the use of this system, contact your home care provider or health

care professional.

5. Contraindications

If you have any of the following conditions, tell your doctor before using this device:

• Insufficient respiratory drive to endure brief interruptions in non-invasive ventilation

therapy

• Acute sinusitis or otitis media

• Epistaxis causing a risk of pulmonary aspiration

• Conditions predisposing to a risk of aspiration of gastric contents

• Impaired ability to clear secretions

• Hypotension or significant intravascular volume depletion

• Pneumothorax or pneumomediastinum

• Recent cranial trauma, cerebrospinal fluid leak or surgery

• Obviously uncooperative or extremely tense

The following side effects may occur during treatment:

- Dryness of the mouth, nose and throat

- Abdominal bloating

- Ear or sinus discomfort

- Eye irritation

- Skin irritation due to the use of a mask

- Chest discomfort

CAUTION!

• Contact your health care professional if symptoms of sleep apnea recur. Contact

your health care professional if you have any questions concerning your therapy.

IMPORTANT TIPS!

• An irregular sleep schedule, alcohol consumption, obesity, sleeping pills, or

sedatives may aggravate your symptoms.

• Please use a mask which meets ISO 17510: 2015.

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6. Specifications

Device Size

Dimensions (L x W x H): 265 mm × 145 mm × 114 mm

Weight: 1.7 kg

Water capacity: To maximum fill line 360 mL

Product Use, Transport and Storage

Operation Transport and Storage

Temperature: 5°C to 35°C (41˚F to 95˚F) -25°C to 70°C (-13˚F to 158˚F)

Humidity: 15% to 93% Non-condensing 15% to 93% Non-condensing

Atmospheric Pressure: 760 ～1060 hPa 760 ～1060 hPa

Heated Humidifier

Humidifier Settings: off, Auto, 1 to 5 (95˚F to 154.4˚F / 35°C to 68°C)

Humidifier Output: No less than 15 mg H2O/L

Environmental Conditions: Maximum airflow, 35°C, 15% relative humidity

Maximum Operating Pressure: 40 cmH2O

Pressure Drop with Humidifier: < 0.4 cmH2O at 60 LPM flow

Maximum Delivered Gas Temperature: ≤ 43°C

Mode of Operation

Continuous

Work Mode

CPAP, AutoCPAP, S, AutoS

SD Card

The SD card can record patient data and fault information

AC Power Consumption

100V - 240 V ～, 50Hz / 60 Hz, 2 A

Device offer to Heated Tubing Communications Port

24 V 18 W

Type of Protection Against Electric Shock

Class II Equipment

Degree of Protection Against Electric Shock

Type BF Applied Part

Degree of Protection Against Ingress of Water

IP22

Pressure Range

4 to 25 cmH2O (in 0.5 cmH2O increments)

Under single fault conditions, ≤30 cmH2O for CPAP and AutoCPAP mode, ≤40 cm

for the rest of the modes.

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Pressure Display Accuracy

±(0.8 cmH2O＋4%)

Static Pressure Stability at 10 cmH2O

±0.5 cmH2O

Dynamic Pressure Stability

Pressures (cmH2O)

10BPM

15BPM

20BPM

6.5

±0.5

±1

Device with humidification and 22mm Tube or Heated Tubing.

Ramp

The ramp time ranges from 0 to 60 minutes.

Sound Pressure Level

< 26 dB, when the device is working at the pressure of 10 cmH2O.

Sound Power Level

< 34 dB, when the device is working at the pressure of 10 cmH2O.

Maximum Flow

Test Pressures (cmH2O)

Measured Pressure at the

Patient Connection Port

(cmH2O)

Average Flow at the

Patient Connection Port

(L/min)

150

Air Tubing

Air tubing

Length

Inner diameter

Tubing

6 ft.(1.83m)

19mm

Heated Tubing

6 ft.(1.83m)

19mm

The Form and the Dimensions of the Patient Connection Port

The 22 mm conical air outlet complies with ISO 5356-1.

PM2.5 Filter

Efficiency: ＞90% for 2.5 micron dust

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Cellular Module

Transportation

Requirements

Shock, severe vibration, and moisture should be avoided

in transportation

Frequency Bands

Bands12, 3, 4, 5, 8, 12, 13, 20, 28

Communication

Mode

LTE Cat M1/ NB1

FCC ID

XPY2AGQN4NNN

Security Measures

Authentication

Enforced on all data channels

(outgoing and incoming)

Encryption

Base 128 encoding

1The LTE bands supported by Cellular Module are defined in above, while the

following Table 1 describes the Transmitting and Receiving frequencies.

Table 1 Transmitting and Receiving frequencies

Parameter

Min.

Max.

Unit

Remarks

Frequency

range FDD

Band 12

(700 MHz)

Uplink

699

716

MHz

Module transmit

Downlink

729

746

MHz

Module receive

Frequency

range FDD

Band 28

(700 MHz)

Uplink

703

748

MHz

Module transmit

Downlink

758

803

MHz

Module receive

Frequency

range FDD

Band 13

(700 MHz)

Uplink

777

787

MHz

Module transmit

Downlink

746

756

MHz

Module receive

Frequency

range FDD

Band 20

(800 MHz)

Uplink

832

862

MHz

Module transmit

Downlink

791

821

MHz

Module receive

Frequency

range FDD

Band 5

(850 MHz)

Uplink

824

849

MHz

Module transmit

Downlink

869

894

MHz

Module receive

Frequency

range FDD

Band 8

(900 MHz)

Uplink

880

915

MHz

Module transmit

Downlink

925

960

MHz

Module receive

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