This document serves as the User Manual for the Luna® II CPAP and Luna® II Auto CPAP devices, models LG2000 and LG2A00, manufactured by BMC Medical Co., Ltd. and distributed by REACT HEALTH.
Function Description
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.
The CPAP (Continuous Positive Airway Pressure) function delivers continuous positive airway pressure throughout the breathing cycle. The Auto CPAP (Automatic Continuous Positive Airway Pressure) function delivers CPAP therapy and provides an air pressure no less than the prescribed one based on the patient's needs. The device also features Reslex, a therapy feature that enables your home care provider to provide pressure relief during exhalation. The Ramp feature allows for a gradual increase in pressure to the prescribed setting, enhancing comfort during the initial phase of sleep.
Important Technical 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:
- Temperature: 5°C to 35°C (41°F to 95°F)
- Humidity: 15% to 93% Non-condensing
- Atmospheric Pressure: 760 to 1060 cmH₂O
- Altitude: Sea level to 2300 m
Transport and Storage:
- Temperature: -25°C to 70°C (-13°F to 158°F)
- Humidity: 15% to 93% Non-condensing
- Atmospheric Pressure: 760 to 1060 cmH₂O
- Altitude: Sea level to 2300 m
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:
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 V - 240 V ~, 50 Hz / 60 Hz, Max 2 A
Device offer to Communications Port:
Type of Protection Against Electric Shock:
Degree of Protection Against Electric Shock:
Degree of Protection Against Ingress of Water:
Pressure Range:
- 4 to 20 cmH₂O (in 0.5 cmH₂O increments), ≤ 30 cmH₂O under single fault conditions.
Static Pressure Stability:
Ramp:
- The ramp time ranges from 0 to 60 minutes.
A-weighted sound pressure level and sound power level:
- When the device is working at the pressure of 10 hPa, its sound pressure level is 28 dB(A) with an uncertainty of 2 dB(A). The sound power level is 36 dB(A) with an uncertainty of 2 dB(A).
Maximum Flow (cmH₂O):
- Test Pressures: 4 (3 L/min), 8 (7 L/min), 12 (11 L/min), 16 (15 L/min), 20 (19 L/min)
- Average Flow at the Patient Connection Port (L/min): 90, 150, 150, 150, 145
- When the working pressure is set to the values listed in the table, the average flow rate at the patient end should be greater than 80% of the corresponding flow value in the table.
Automatic leak compensation:
- The pressure error is ± 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:
Maximum Delivered Gas Temperature:
The Form and the Dimensions of the Patient Connection Port:
- The 22 mm conical air outlet complies with ISO 5356-1.
Usage Features
First Time Setup:
- Placing the Device: Place the device on a firm, flat surface. Avoid dropping or mishandling the device.
- Installing the Air Filter and Filter Cap: Attach the air filter to the filter cap and install the filter cap containing the air filter to the device.
- Connecting to Power: Plug the power adapter into the DC Inlet on the back of the device, connect the power cord to the power adapter, and plug the other end of the power cord into the power outlet.
- Assembling the Tube and Mask: Connect one end of the tube to the air outlet of the device and the other end to the mask according to the user manual for the mask.
- Using Oxygen with the Device: Oxygen can be added at the mask connection. Ensure the oxygen supply is turned off first, then the device. Supplemental oxygen must not be used while smoking or in the presence of an open flame.
- Inserting the SD Card: Insert the SD card into the SD Card Slot. The device will display an SD card symbol on the Main Interface if inserted correctly.
- Using the Cellular Module: For more details, refer to the corresponding user manual.
- Starting Treatment: Connect the device to a power outlet, press the Knob, and the device will start delivering air.
Routine Use:
- Connecting the Tube: Connect the power cord, power adapter, and tube properly according to the instructions in the First Time Setup.
- 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 there are no airflow leaks around the mask.
- Turning on the Airflow: Press the Knob to turn on the airflow. The screen will display treatment pressure and other information.
- 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.
- 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.
- 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.
Heated Humidifier:
- Filling the Water Chamber: Remove the water chamber, open the cap, and fill the water chamber with approximately 360 ml of water. Make sure the water does not exceed the maximum water level line. Close the cap after it is filled with water and return it to the device.
- Emptying the Water Chamber: Remove the water chamber and open the cap. Pour any remaining water out of the water chamber.
- 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.
Navigating the Patient Menu:
- Accessing the Main Interface: Connect the power cord and power adapter properly. The screen displays the Main Interface.
- Bringing up the Initial Setup Interface: From the Main Interface, press and hold the Ramp Button for three seconds. The screen displays the Initial Setup Interface of the Patient Menu.
- 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.
- 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.
- Adjusting Options: Adjust the option by turning the Knob.
- Confirming Adjustments: Confirm your adjustment to an option by pressing the Knob.
- Turning Pages: When the cursor is on Brightness, the last option shown, the remaining options will appear on a new page if you continue to turn the Knob clockwise.
- Exiting the Patient Menu: Return to the initial Setup Interface or the Main Interface.
Maintenance Features
Cleaning:
- General Cleaning: Cleaning the device and its accessories is essential to prevent respiratory infections. 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. Avoid the use of any CPAP cleaner or disinfection device that relies on ozone (i.e. activated oxygen). Device warranty may terminate if the damage is caused by the use of an ozone cleaner. In order to prevent contamination of the device, use only manufacturer-approved filters on this device conforming to ISO 23328-1:2003 and ISO 23328-2:2002 standards. The device shall not be serviced or maintained while a patient is using it.
- Cleaning the Mask and Headgear: Refer to the cleaning instructions in the user manual for the mask.
- Cleaning the Cellular Module: Wipe the surface of the Cellular Module with a clean, soft, and slightly damp cloth. It is recommended to clean the Cellular Module once a week.
- Cleaning the Water Chamber: Preparation tools: soft bristle brush, drinking quality water, mild liquid detergent. Remove the Water Chamber according to instructions. Open the cap of the water chamber, as shown. Clean the water chamber with a soft bristled brush for one minute after soaking the water chamber in detergent solution (see table below) for 5 minutes. Pay particular attention to all crevices and cavities. Then rinse with running water for 5 minutes. Wipe it dry with a soft cloth or air dry out of direct sunlight.
- Detergent: Alconox (diluted at 1%)
- Water temperature: Warm water (approx. 113 to 140°F or 45 to 60°C)
- Cleaning the Enclosure: Wipe the surface of the device with a soft, slightly damp cloth. 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.
- Cleaning the Tube: For details, refer to the cleaning instructions in the user manual of the L1 tube. It is recommended to clean the tube once a week.
- Cleaning and Replacing the Air Filter: Open the air filter cap to remove the air filter. Put the new air filter in the filter area, and then place the filter cap back properly. When the filter is dirty, the filter can be cleaned as follows: Hold the air filter and align it with the tap water flow. Rinse the air filter with running water. When cleaning, gently press the air filter, but do not pull the air filter. Allow the filter to air dry completely before reinstalling it. Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter. 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 6 months (it may be replaced more frequently based on actual sanitary conditions). Operating the device with a dirty air filter may stop it from working properly and may cause damage to the device. Replacing the air filter and filter cap, device must be unplugged.
Reordering:
- Contact your home care provider to order accessories or replacement filters. The device does not require routine servicing.
Disposal:
- When the device reaches the end of its service life, dispose of the device and packaging in accordance with local laws and regulations.
Limited Warranty:
- REACT HEALTH 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 REACT HEALTH to the dealer. If the product fails to perform in accordance with the product specifications, REACT HEALTH will repair or replace, at its option, the defective material or part. REACT HEALTH will pay customary freight charges from REACT HEALTH 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. REACT HEALTH 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: REACT HEALTH, 5101 Fruitville Rd., Suite 200, Sarasota, FL 34232, T: (863) 226-6285. For additional information, please visit our Patient Portal at: www.reacthealth.com. icodeconnect.com – Web-based cloud for report generation and storage. BMC Medical Co., Ltd., Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District, 100073 Beijing, PEOPLE’S REPUBLIC OF CHINA, Tel: +86-10-51668880, Fax: +86-10-51668880 Ext. 810, URL: en.bmc-medical.com, E-mail: intl@bmc-medical.com.
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