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

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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.

• Th

e 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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Содержание G3 B25A

Страница 1: ...User Manual G3 B25A Luna G3 BPAP 25A ...

Страница 2: ...nnecting to Power Cord Locker 16 12 5 Assembling the Tubing Heated Tubing and Mask 17 12 6 Using Oxygen with the Device 18 12 7 Inserting the SD Card Only for the device that equipped with SD card 19 12 8 Starting Treatment 20 13 Routine Use 20 13 1 Connecting the Tubing 20 13 2 Adjusting the Tubing 20 13 3 Turning on the Airflow 20 13 4 Heating the Water 20 13 5 Using the Ramp Feature 21 13 6 Acc...

Страница 3: ...nd Corresponding Descriptions 30 17 Alert 32 18 Cleaning 33 18 1 Cleaning the Mask and Headgear 33 18 2 Cleaning the Water Chamber 33 18 3 Cleaning the Transfer Box 34 18 4 Cleaning the Enclosure 35 18 5 Cleaning the Tubing 35 18 6 Replacing the Air Filter PM2 5 Filter 35 19 Traveling with the Device 36 20 Transferring the Device to Another Patient 37 21 Reordering 37 22 Technical Support 37 23 Di...

Страница 4: ...y 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 Se...

Страница 5: ...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 ...

Страница 6: ...evel 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 ...

Страница 7: ...erapy 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 s...

Страница 8: ...mental 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 Commun...

Страница 9: ...B 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 4 10 15 20 Measured Pressure at the Patient Connection Port cmH2O 3 9 14 19 Average Flow at the Patient Connection Port L min 90 150 150 150 Air Tubing Air tubing Length Inner diameter Tubing 6 ft 1 83m 19mm Heated Tubing 6 ft 1 8...

Страница 10: ...encies 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 re...

Страница 11: ...irway Pressure CPAP maintains a constant level of pressure throughout the breathing cycle AutoCPAP Delivers CPAP therapy and provides an air pressure no less than the prescribed pressure based on the patient s needs S A bi level mode which responds to both inhalation and exhalation by increasing pressure when you start to inhale and decreasing pressure when you start to exhale There is no automati...

Страница 12: ...g to the patient s respiratory events during a certain time period SmartA With this feature the device adjusts Ramp P and Min APAP according to the patient s respiratory events during a certain time period SmartB With this feature the device adjusts Ramp P and Min APAP according to the patient s respiratory event during a certain time CPAP Continuous Positive Airway Pressure EPAP Expiratory Positi...

Страница 13: ...evice to change from EPAP to IPAP You can adjust this time for your comfort Res Rate Respiratory Rate Number of breaths per minute 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...

Страница 14: ... and accessories manufactured or recommended by 3B MEDICAL 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 i...

Страница 15: ... Knob Display Screen Home Button Start Stop Button Fig 11 1 Name Function Start Stop Button Start Stop delivering air Display Screen Display menus for operation messages monitoring data etc Home Button Return to the previous menu or main interface Knob Adjust device settings ...

Страница 16: ...onnected to the plug of the heated tubing DC Inlet An inlet for the DC power supply Filter Cap Air Inlet Cover and secure the air filter which is used to filter dust and pollen in the air entering the device Transfer Box SD Card Slot Fig 11 3 Name Function Transfer Box Connects the device to the water chamber SD Card Slot Insert the SD card into this slot ...

Страница 17: ...atures 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 ...

Страница 18: ...n the device is operating Device must be unplugged when installing the air filter and filter cap or PM2 5 filter 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 Power Adapter Power Cord DC Inlet Fig 12 4 Note The length of the power ...

Страница 19: ...S 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 Connecting to Power Cord Locker 1 Insert the power cord locker into the device as shown in Fig 12 5 and then rotated to the left for assembly to the device DC Inlet Power Cord Locker Fig 12 5 2 Ope...

Страница 20: ... Connect the heated tubing joint to the air outlet of the device and then insert the power plug into the heated tubing port on the back of the device as shown in Fig 12 8 Power Plug Heated Tubing Air Outlet Heated Tubing Heated Tubing Joint Fig 12 8 If the heated tubing is connected correctly the line next to the icon will become a number in the Main Interface on the screen of the device as shown ...

Страница 21: ...nal accessories are in place If you are using a mask with a built in exhalation port connect the mask s connector to the tubing If you are using a mask with a separate exhalation port connect the tubing 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 mas...

Страница 22: ...stem 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 sh...

Страница 23: ...2 Connect the mask and headgear according to the user manual for the mask CAUTION Before each use examine the tubing for any damage or debris If necessary clean the tubing to remove the debris Replace any damaged tubing Make sure that the mask does not leak 13 2 Adjusting the Tubing Lie down on your bed and adjust the tubing so it is free to move if you turn during sleep Adjust the mask and headge...

Страница 24: ...ten as you wish during sleep The ramp feature is not prescribed for all users 13 6 Accessing the iCode After the device is powered on move the cursor to the icon by turning the Knob as shown in the Fig 13 1 Access the iCode information by pressing the Knob the screen displays the iCode interface as shown in the Fig 13 2 Fig 13 1 Fig 13 2 13 7 Turning the Device Off Take off the mask and headgear p...

Страница 25: ...ater Chamber 14 1 1 Removing the Water Chamber Press down the water chamber and then remove it as shown in Fig 14 1 Fig 14 1 WARNING Turn the device off and allow approximately 15 minutes for the heater plate and water to cool 14 1 2 Filling Water 1 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...

Страница 26: ... 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 IMPORTANT TIP It is not necessary to remove the water chamber from the device The users can open the cap of the water chamber directly to fill the water 14 1 3 Returning the Water Chamber Close the cap after it is filled with water as shown in Fig 14 5 ...

Страница 27: ...ap as shown below and pour any remaining water out of the water chamber Fig 14 7 CAUTION Empty and air dry the water chamber when the device is not in use 3 Returning 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 instruction...

Страница 28: ...ower Nasal dryness means that the humidity level is too low and should be set higher 15 Using the Cellular Module The Luna G3 BPAP 25A with Cellular Module can wirelessly communicate with iCodeConnect iCodeConnect is intended to augment the standard follow up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the p...

Страница 29: ...device screen will not show the signal icon if the Cellular Module is connected to the device improperly or if the Module is not working properly WARNING To ensure successful data transmission through the Cellular Module computers televisions radios or similar devices should not be placed near the Cellular Module 16 Navigating the Patient Menu 16 1 Steps to Navigating the Patient Menu 16 1 1 Acces...

Страница 30: ...reen as shown in Fig 16 3 Fig 16 3 The first icon on the upper part of the screen indicates the Preheat Function Icon the second icon indicates the Accessories the third icon indicates Mask Setup Icon the fourth icon indicates the Report Interface Icon and the fifth icon indicates the Initial Setup Icon As you turn the Knob the cursor switches among the five icons and the interface displayed on th...

Страница 31: ...tient Menu as shown in Fig 16 4 Fig 16 4 Note The Heated Tubing option can only be adjusted when the device is connected to the Heated Tubing as shown in Fig 16 5 Fig 16 5 16 1 3 Selecting Options As you turn the Knob clockwise the cursor moves downwards from one option to another When the cursor is on the desired option press the Knob and the background color of the option will change meaning tha...

Страница 32: ...ckwise the numerals decrease indicating a lower humidity level as shown in Fig 16 7 Fig 16 7 16 1 5 Confirming Adjustments Confirm your adjustment to an option by pressing the Knob The option is then displayed in white as shown in Fig 16 8 Fig 16 8 16 1 6 Turning Pages When the cursor is on Work screen saver the last option shown in Fig 16 8 the remaining options will appear on a new page if you c...

Страница 33: ...ncreases the heat rises accordingly Off means the heat is turned off Note Heated Tubing is displayed in the patient menu only when it is connected Ramp Time Auto 0 Max Ramp In order to increase comfort and help the patient fall asleep easily the pressure can increase graduallywhen the Ramp feature is enabled The ramp time during which the initial pressure rises to the prescribed treatment pressure...

Страница 34: ... Full Face full face mask Nasal nasal mask and Pillow nasal pillow mask The default mask type is Nasal but the patient can choose other suitable masks as well When selecting masks other than the above three types of 3B MEDICAL masks the patient can identify the masks as other iCode iCode iCode QR iCode QR iCode provides access to the patient s compliance data during a recent time period The iCode ...

Страница 35: ...midifier is connected an audible alert will sound if the humidifier fails to work in 10 minutes the screen will display Humidifier Failure Please Change Filter When the Filter Alert feature is enabled an audible alert will sound if the preset replacement time is reached but the air filter hasn t been replaced the screen will display Please Change Filter The default setting is Off Please Change Tub...

Страница 36: ... 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 ...

Страница 37: ...ater 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 clean the water chamber and change the water daily 18 3 Cleaning the...

Страница 38: ... tubing from the device and mask before cleaning 2 Clean the tubing in warm water and mild soap and then rinse it in clean water thoroughly 3 After cleaning air dry the tubing in a cool well ventilated area and avoid direct sunlight It takes approximately 30 minutes to completely air dry the tubing Ensure the tubing is completely dry before re use CAUTION It is recommended to clean the tubing once...

Страница 39: ...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 6 the accuracy of the leakage alert will be affected 1 Use the 3B MEDICAL carry...

Страница 40: ...u 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...

Страница 41: ...event the mouth from opening during sleep or use a full face mask Contact your physician for details Eye irritation The mask size or model may not be correct or the mask is not positioned correctly thereby leading to air leakage Narrow the distance between the forehead support of the mask and the forehead Note that adjusting the mask too tight may leave marks on the patient s face Contact your equ...

Страница 42: ...if the treatment pressure is set too low Patients may experience a variance in time to acclimate to their therapy If the problem persists contact your physician or home care company for assistance Obstructive sleep apnea symptoms recur There are many causes of recurring symptoms including weight change medication or alcohol and poor mask fit Contact your physician for assistance The device is too ...

Страница 43: ...may be holes in the mask or pressure sensing tubing Contact your equipment supplier It is a faulty device Contact your equipment supplier The device produces very low pressures The air inlet of the device may be blocked Replace the air filter see 18 7 Replacing the Air Filter PM2 5 Filter and clean the air inlet Make sure the air inlet is unblocked The treatment pressure has been changed accidenta...

Страница 44: ...vel of probability for loss of information within the network The data has little effects on treatment effectiveness These are key data and their integrity should be ensured but they do not involve real time control of therapeutic medical devices and do not rely on network quality Wrong transmission of the information described in sections above data will be abandoned based on a checking mechanism...

Страница 45: ...idance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply netwo...

Страница 46: ...onment Surge IEC 61000 4 5 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle 70 UT 25 30 cycle At 0 0 UT 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 225 270 ...

Страница 47: ...cturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitter as determined by an 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 ...

Страница 48: ...ons equipment Rated maximum output of transmitter W 150 kHz 80 MHz p d 17 1 80 MHz 800 MHz p d 35 0 800 MHz 2 5 GHz p d 70 0 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 refl...

Страница 49: ... 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 Recommended separation distance 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 fixed R...

Страница 50: ... 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 This device may be interfered with by other equipment even if that other equipm...

Страница 51: ...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 INCIDENTA...

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