Luna II CPAP Machine, Integrated Heated Humidifier - 3B Medical

3B Luna II CPAP with Integrated Heated Humidifier delivers continuous positive airway pressure for the treatment of obstructive sleep apnea. The small size and low weight of the CPAP device allows for easy portability when traveling or on vacation. Treatment through positive pressure helps individuals who experience sleep apnea.

This 3B Medical CPAP Device uses an optional integrated heated humidifier. This device warms the air in the flow generator. The humidified air keeps your airway passages moist so that they do not dry out or irritate. The warm, moist air is comfortable during your sleep, helping you to stay asleep.

  Luna II CPAP Device Profile

The design of the 3B Luna 2 CPAP Machine is for Portable Sleep Therapy. It is for single patient use and requires a prescription for use in-home or within a professional clinical environment. It is for adult use only.

Patients with sleep apnea are at risk of numerous other illnesses that can cause serious harm. "Accelerated atherosclerosis and increased cardiovascular risk are frequently reported in patients with obstructive sleep apnea (OSA) syndrome.... The relationship between vascular risk and OSA syndrome based on large cohort studies... [associate] the disease to several cardiovascular risk factors and vascular pathologies.... These include increased oxidative stress and inflammation as well as several disorders of coagulation and lipid metabolism." ¹

Another study also found that OSA is a major risk factor for cardiovascular disease. "OSA is considered a cardiovascular risk factor, which increases the likely of suffering stroke, congestive heart failure, arterial hypertension, pulmonary hypertension, coronary artery disease, cardiac arrhythmias, and acute myocardial infarction.... Since OSA causes irregularities in the [sympathetic nervous system] (SNS) function, OSA has been associated with an increased risk of cardiovascular events and mortality." This same study concluded that "CPAP treatment should not be delayed. Severe OSA patients should be advised that even a single night without CPAP has changes in the cardiac rate, which are corrected with CPAP. Hence, to use or not to use the CPAP for a single night does matter."²

Luna II Therapies

CPAP - provides continuous positive airway pressure at a constant level throughout the breathing cycle. The Ramp feature allows you to start with low pressure and gradually increase the pressure to the prescribed therapeutic pressure setting, allowing you to get to sleep comfortably and to slowly adjust to the pressure. This device features a ramp button, which can increase patient comfort, reduces pressure, and gradually increases to the prescription pressure setting while you sleep. However, it is not advised for use for all patients. Please consult your doctor before using this feature.

Auto PAP - offers an auto-adjusting pressure throughout the night to meet the patient's needs, providing a minimum pressure of no less than the prescribed amount.

What is the difference between CPAP and Auto PAP?

The significant difference between CPAP and APAP machines is pressure delivery. CPAP supplies air pressure to keep the patient's airway open to control sleep apnea. CPAP delivers a fixed and constant pressure that is set by the patient or caregiver. Once the machine pressure is set, that pressure is consistent during the patient's sleep. That pressure does not deviate throughout the night. It is continuous and invariable.

On the other hand, Auto PAP or APAP provides pressure that adjusts to the needs of the patient throughout their sleep. An APAP machine senses the needs of the patient and automatically increases pressure to unblock airway passages. When airway passages are clear, the machine adjusts back to the set pressure. The machine monitors the patient's breath and resistance in breathing from breath to breath. Resistance sensed by the machine triggers the machine to increase pressure to overcome that resistance. This monitoring and auto-adjusting of pressure takes place all through the night, keeping the right amount of pressure to keep the patient's airways open and allow for comfortable breathing.

iCode

iCode is a feature that provides access to compliance and therapy management functions. This feature provides codes displayed in the Patient Menu with a sequence of numbers. There is also an iCode QR code and an iCode QR+ code that offers two-dimensional coding for easy recognition and implementation.

SD Card

The SD Card allows the transfer of data manually from the CPAP device to the patient's or caregiver's computer. This allows the user or caregiver to monitor compliance and manage therapy. The data can help the caregiver to determine if the pressure setting is too high or too low and to make any adjustments necessary for the patient's comfort and treatment.

Cellular Module or WiFi Kit

The wifi and cellular module allow for the transmission of data from the CPAP machine directly to your smartphone or to the doctor's office. This data helps to manage therapy and monitor compliance.

Heated Humidifier

The humidifier offers moisture and warm air to reduce nasal dryness and irritation to the airway passages. This feature allows the CPAP patient to engage in comfortable sleep apnea therapy sessions. Below are the procedures for filling the water chamber of the humidifier.

1. Turn off the device and allow the heater plate and water to cool for at least 15 minutes.
2. Pull the water chamber out of the device.
3. Open the cap and pour out any remaining water still in the chamber down your sink.
4. Fill the chamber with distilled water to the 360 mL water level line.
5. Do not overfill.
6. Change the water before each therapy.
7. Close the cap and reinsert the water reservoir into the device.
8. Adjust the humidity level by following the instructions in the manual.

Luna II Features

Product Features and Benefits

• Sleek, Modern Design
• Adjustable Settings
• Color LCD Display
• Dual Chamber Humidifier
• Provides Quality Efficiency
• Full-Color LCD Screen
• Unibody Construction for Small Profile
• Lightweight Portability
• Pressure Indicator
• Simple Water Chamber Design
• Single Dial Menu
• Data Capture and Transmission
• iCode Compliance Data

Product Dimensions

Product Specifications

• Product Number: LG2000
• Length: 10.7 Inches
• Width: 7.2 Inches
• Height: 4.5 Inches
• Weight: 4.1 Pounds
• Pressure Range: 4 ~ 20 cmH²O
• Ramp Range: 0 to 60 Minutes
• Sound Level: 28 dBA at <10 cmH²O, 38 dBA at >10 cmH²O
• Mode of Operation: Continuous
• Work Mode: CPAP
• Humidification Water Chamber Capacity: 360 mL
• Operating Transport and Storage: AC 120 - 220 V, 50/60 Hz, Maz 2 Amp
• Relative Humidity: 15 Percent to 93 Percent (Non-Condensing)
• Oxygen Concentration: 93 Percent +3Percent-2Percent
• Tube Length: 6 Feet
• HCPCS Code: E0601
• Manufacturer: 3B Medical
• Device Warranty: Two-Year
• Accessories Warranty: Three-Month

Set-Up Instructions

How to Use the Device

1. Connect the power adapter to the DC inlet on the machine.
2. Connect the power adapter to the power cord.
3. Connect the power cord to an AC power outlet.
4. Connect one end of the tube to the mask.
5. Connect the other end of the tubing to the air outlet on the machine.
6. Adjust the tubing while lying on your bed to be free of kinks and encumberments.
7. Adjust the mask headgear to a comfortable fit and seal to your face.
8. Press the "on" button to turn on the airflow.
9. Check the humidifier level to ensure it is set to the right amount.
10. Keep an eye on the humidifier indicator light to show when it is "on" or "off."

Possible Side Effects

• Eye Irritation
• Chest Discomfort
• Sinus Irritation
• Ear Discomfort
• Abdominal Bloating
• Dryness of the Nose, Mouth, and Throat
• Skin Irritation Due to Use of Mask

Air Filter

Air Filter Replacement

1. Unplug the device before replacing the air filter and filter cap.
2. Open the air filter cap to remove the air filter.
3. Put the new air filter in the filter chamber and then replace the filter cap.
4. To avoid damage to your device, do not place the air filter in direct sunlight, humid environments, or temperatures below freezing.
5. Replace the air filter at least every two weeks. The filter may require more frequent replacement based on actual environmental conditions.
6. Operating the device with a dirty air filter may stop it from working properly and may cause damage to the device.

How to Clean Your CPAP Device

• Regular cleaning of the device and its accessories helps prevent respiratory infections.
• Unplug the device before cleaning to prevent electrical shock.
• Ensure that the water chamber of the device has cooled down the requisite 15 minutes before cleaning.
• Use a mild soap that is non-toxic to humans.
• Do not use cleaning solutions containing chlorinated lime, chlorine, or aromatics.
• Do not use liquid soap containing moisturizing agents or antimicrobials. These solutions may harden cleaned materials or reduce their lifespan.
• Do not clean or dry the device and its accessories with temperatures higher than 176 Fahrenheit (80 Celsius). High temperatures could reduce product life.
• Do not immerse the device in any fluids.
• Clean the mask and tube daily after each use.
• Do not use chemicals or sterilization methods with this device and its components.
• Do not open or modify this device. There are no user-serviceable parts inside.
• Repairs and servicing should only be performed by an authorized service agent.

How to Clean the Water Chamber

1. Lift the cover to open the water chamber.
2. Using a soft cloth, clean water, and mild detergent or soap, wipe the chamber clean.
3. After cleaning, wipe with a dry cloth that is scratch-resistant.
4. Refill the water chamber with distilled water to the fill line.
5. Return the water chamber to the humidifier compartment and close the cover.
6. It is recommended to clean the chamber once a week.

Other CPAP Supplies and Options for Your Consideration

• CPAP Masks
• CPAP Filters
• Accessories

Footnotes

• ¹ Stiefel, Pablo, et al. "Obstructive sleep apnea syndrome, vascular pathology, endothelial function and endothelial cells and circulating microparticles." Archives of medical research 44.6 (2013): 409-414. (Last Accessed June-01-2020)
• ² Kufoy, Ernesto, et al. "Changes in the heart rate variability in patients with obstructive sleep apnea and its response to acute CPAP treatment." Plos one 7.3 (2012). (Last Accessed June-01-2020)