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3B G3 Series User Manual

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User Manual
G3 B25A
Luna G3 BPAP 25A

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  • Page 1 User Manual G3 B25A Luna G3 BPAP 25A...

  • Page 2: Table Of Contents

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Table of Contents 1. Introduction ································································································ 1 2. Symbols ······································································································ 1 2.1 Control Buttons ·················································································· 1 2.2 Device Symbols ················································································· 1 3. Warning, Caution and Important Tip ······························································ 3 4. Intended Use ······························································································· 3 5.
  • Page 3 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 15. Using the Cellular Module··········································································· 25 16. Navigating the Patient Menu ······································································ 26 16.1 Steps to Navigating the Patient Menu ··············································· 26 16.1.1 Accessing the Main Interface ················································ 26 16.1.2 Bringing up the Initial Setup Interface ····································· 28 16.1.3 Selecting Options ·································································...

  • Page 4: Introduction

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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.
  • Page 5 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Manufacturer 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...

  • Page 6: Warning, Caution And Important Tip

    • 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.

  • Page 7: Contraindications

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

  • Page 8: Specifications

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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)
  • Page 9 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Pressure Display Accuracy ±(0.8 cmH O＋4%) Static Pressure Stability at 10 cmH ±0.5 cmH Dynamic Pressure Stability 10BPM 15BPM 20BPM Pressures (cmH ±0.5 ±0.5 ±0.5 ±1 ±1 ±1 ±1 ±1 ±1 Device with humidification and 22mm Tube or Heated Tubing.
  • Page 10 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Cellular Module Transportation Shock, severe vibration, and moisture should be avoided Requirements in transportation Frequency Bands Bands 2, 3, 4, 5, 8, 12, 13, 20, 28 Communication LTE Cat M1/ NB1 Mode FCC ID XPY2AGQN4NNN...

  • Page 11: Available Therapies

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Parameter Min. Max. Unit Remarks Frequency Uplink 1710 1755 Module transmit range FDD Band 4 Downlink 2110 2155 Module receive (1700 MHz) Frequency Uplink 1710 1785 Module transmit range FDD Band 3 Downlink 1805 1880...

  • Page 12: Glossary

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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 sleep events, such as apnea, hypopnea etc. Auto Off When this feature is enabled, the device automatically discontinues therapy whenever the mask is removed.

  • Page 13: Model

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

  • Page 14: Package Contents

    • Do not pile up the long tubing at the head of the bed, as it may be a strangulation hazard. • Do not connect any equipment to the device unless recommended by 3B MEDICAL or your health care provider.

  • Page 15: System Features

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 11. System Features Start / Stop Button Display Screen Home Button Knob Fig. 11-1 Name Function Start / Stop Button Start / Stop delivering air Display menus for operation, messages, monitoring Display Screen data, etc.
  • Page 16 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Fig. 11-2 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...

  • Page 17: First Time Setup

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

  • Page 18: Connecting To Power

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

  • Page 19: Connecting To Power Cord Locker

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

  • Page 20: Assembling The Tubing / Heated Tubing And Mask

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 12.5 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. 12-7. Air Outlet Tubing Fig.

  • Page 21: Using Oxygen With The Device

    • In order to minimize the risk of CO 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.

  • Page 22: Inserting The Sd Card (Only For The Device That Equipped With Sd Card)

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

  • Page 23: Starting Treatment

    • 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, stomach bloating, or severe headache when using the device, contact your physician or qualified medical personnel immediately.

  • Page 24: Using The Ramp Feature

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 13.5 Using the Ramp Feature Every time the feature is enabled, the pressure will drop to the set initial pressure, and then gradually rise to the prescribed treatment pressure according to the preset ramp time, so as to ensure patient comfort.

  • Page 25: Heated Humidifier

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 14. Heated Humidifier The humidifier is integrated into your device. 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.

  • Page 26: Returning The Water Chamber

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

  • Page 27: Emptying The Water Chamber

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

  • Page 28: Using The Cellular Module

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

  • Page 29: Navigating The Patient Menu

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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 signals until one is found. If the signal is strong, the signal icon appears in the Main Screen, as shown in Fig.
  • Page 30 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Status Bar Menu Bar Display Space Fig. 16-1 Fig. 16-2 Note: The above interface only applicable to the device, it does not activate the SmartC, SmartA or SmartB. If the SmartC, SmartA or SmartB is enabled, the symbol will appear in the status bar at the top of the screen, as shown in Fig.

  • Page 31: Bringing Up The Initial Setup Interface

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 16.1.2 Bringing up the Initial Setup Interface After the 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.

  • Page 32: Adjusting Options

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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 numerals increase, indicating a higher humidity level.

  • Page 33: Exiting The Patient Menu

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 16.1.7 Exiting the Patient Menu The users can press the Home to return to the Main Interface shown in Fig. 16-1. 16.2 Options of the Patient Menu and Corresponding Descriptions Option Range Description There are five humidity levels available.
  • Page 34 “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 masks, the patient can identify the masks as other. iCode provides access...

  • Page 35: Alert

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 17. Alert Alert Message Description An audible alert will sound in 6s 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.

  • Page 36: Cleaning

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

  • Page 37: Cleaning The Transfer Box

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 (2) Cleaning the Water Chamber: You may also clean the water chamber with a soft cloth (dip the soft cloth in liquid soap if necessary), rinse it thoroughly, and then wipe it dry with a soft cloth. (3) Replacing the Water Chamber according to instructions found in 14.1.3.

  • Page 38: Cleaning The Enclosure

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 (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. 18.4 Cleaning the Enclosure Wipe the surface of the device with a soft, slightly damp cloth.

  • Page 39: Traveling With The Device

    • 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. (1) Use the 3B MEDICAL carrying case to carry the device and accessories as a carry on. Do not put them in your checked baggage.

  • Page 40: Transferring The Device To Another Patient

    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.

  • Page 41: Troubleshooting

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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...
  • Page 42 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 Problem Possible Cause Solution(s) Turn the humidity setting down or raise the room temperature. When the humidifier is used, Place the tubing under the quilt the humidified air tends to or use the tubing cover. Water in mask condense cold...

  • Page 43: Common Problems In The Device And Corresponding Solutions

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 24.2 Common Problems in the Device and Corresponding Solutions Problem Possible Cause Solution(s) Take a few deep breaths with The Auto On / Off feature the mask on, and the device is enabled.

  • Page 44: Information Of Qos

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 25. Information of QoS The data transmission between the Luna G3 BPAP 25A 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, compliance data, system settings, and device information.

  • Page 45: Emc Requirements

    Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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.
  • Page 46 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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.
  • Page 47 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0 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.
  • Page 48 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/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...
  • Page 49 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/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.
  • Page 50 Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/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.

  • Page 51: Limited Warranty

    (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.

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