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3B Medical Line II QX Series, User Manual

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3B Medical Line II QX Series User Manual Download Page 38

 

Luna II QX CPAP / Luna II QX Auto CPAP User Manual V1.1

 

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23. 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. 

Emissions Test 

Compliance 

Electromagnetic Environment - 

Guidance 

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 

network that supplies buildings 

used for domestic purposes 

Harmonic emissions 

IEC 61000-3-2 

Class A 

Voltage fluctuations   

/ flicker emissions 

IEC 61000-3-3 

Complies 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Luna II QX CPAP / Luna II QX Auto CPAP User Manual V1.1

Summary of Contents for Line II QX Series

Page 1: ...USER MANUAL www 3Bproducts com Luna II QX CPAP Luna II QX Auto CPAP Model No LQX2000 Model No LQX2A00 Internet Model ...

Page 2: ... Tube 16 13 2 Adjusting the Tube 16 13 3 Turning on the Airflow 16 13 4 Heating the Water 16 13 5 Using the Ramp Button 17 13 6 Turning the Device Off 17 14 Heated Humidifier 17 14 1 Filling the Water Chamber 17 14 1 1 Removing the Water Chamber 17 14 1 2 Filling Water 18 14 1 3 Inserting the Water Chamber 18 14 2 Emptying the Water Chamber 19 14 3 Setting the Humidity Level 20 15 Navigating the P...

Page 3: ...ng the Air Filter 29 18 Traveling with the Device 29 19 Reordering 31 20 Technical Support 31 21 Disposal 31 22 Troubleshooting 32 22 1 Common Problems in Patients and Corresponding Solutions 32 22 2 Common Problems in the Device and Corresponding Solutions 34 23 EMC Requirements 35 24 Limited Warranty 40 Luna II QX CPAP Luna II QX Auto CPAP User Manual V1 1 ...

Page 4: ...ifficulties or problems during use please contact your homecare provider or physician 2 Symbols 2 1 Control Buttons Ramp Button Mute Button Knob 2 2 Device Symbols Follow Instructions for Use Operating Instructions Type BF Applied Part mask Class II Double Insulated AC Power DC Power IP22 12 5 mm Diameter Dripping 15ºtilted Hot Surface Serial Number of the Product Manufacturer 1 Luna II QX CPAP Lu...

Page 5: ...entative in the European Community Disassembly is prohibited European CE Declaration of Conformity Lot number Non Ionizing Radiation SD Card WEEE Marking Air Inlet Air Outlet Logo of BMC Medical Co Ltd Logo of 3B Medical Inc 2 Luna II QX CPAP Luna II QX Auto CPAP User Manual V1 1 ...

Page 6: ...ended to supersede established medical protocols 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...

Page 7: ...cal fold polyp etc Relative Contraindications Severe coronary heart disease complicated with left ventricular failure acute otitis media excessive respiratory secretions and weak cough weak spontaneous breathing nasal or oral tracheal intubation and tracheotomy severe nasal congestion caused by a variety of conditions lung bullae and allergies to breathing masks etc The following side effects may ...

Page 8: ... Output No less than 10 mg H2O L Environmental Conditions Maximum airflow 35 C 15 relative humidity Mode of Operation Continuous Work Mode For LQX2000 CPAP For LQX2A00 CPAP Auto SD Card The SD card can record patient data and fault information AC Power Consumption 100 240 V 50 60 Hz Max 2 A Device offer to USB Communications Port 5 V 2 0 A Type of Protection Against Electric Shock Class II Equipme...

Page 9: ...ured Pressure at the Patient Connection Port cmH2O 3 9 14 19 Average Flow at the Patient Connection Port L min 85 135 140 140 Automatic leak compensation The pressure error 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 Length 6 ft 1 83 m Maximum Delivered Gas Temperature 43 C The Form and the Dimensions of the Patient Connection Po...

Page 10: ...tion of spontaneous breathing Auto Adjust CPAP pressure automatically to improve patient comfort based on monitoring of apnea and snoring events Auto Off When this feature is enabled the device automatically discontinues therapy whenever the mask is removed Auto On With this feature the device automatically initiates therapy when you breathe into the mask CPAP Continuous Positive Airway Pressure i...

Page 11: ...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 mm dd yy dd mm yy Denotes date 9 Model Model Product Description Product Contents Optional Accessory Work Mode Maximum Work Pressure cmH2O LQX2A00 Device 3...

Page 12: ...evice When using optional accessories always follow the instructions enclosed with the accessories WARNINGS This device should only be used with the mask and accessories manufactured or recommended by 3B Medical Inc 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 ...

Page 13: ...tly proportional to the humidity level If the indicator lights are off it means the humidifier is turned off Mute Button Press this button to mute the alert However if the problem causing the alert is not solved the alert will sound again two minutes later Knob Start treatment and adjust device settings Ramp Button Enable the Ramp feature Display Screen Display menus for operation messages monitor...

Page 14: ...disconnect the power cord and discontinue use Contact your home care provider immediately If the room temperature is warmer than 95 F 35 C the airflow produced by the device may exceed 109 4 F 43 C The room temperature must be kept below 95 F 35 C while the patient uses the device CAUTIONS If the device has been exposed to either very hot or very cold temperatures allow it to adjust to room temper...

Page 15: ...air filter to the filter cap as shown in Fig 11 1 Filter Cap Air Filter Fig 12 1 2 Install the filter cap containing the air filter to the device as shown in Fig 11 2 Fig 12 2 CAUTION The air filter must be in place when the device is operating Installing the air filter and filter cap device must be unplugged 12 3 Connecting to Power 1 Insert the plug of the power adapter into the DC Inlet on the ...

Page 16: ...re Connect to appropriate power for proper operation of the device CAUTION Inspect the power cord often for any signs of damage Replace a damaged cord immediately IMPORTANTS 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 Assembling the Tube and M...

Page 17: ...n 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 Explanation of Warning When the device is turned off but the oxygen flow still exists oxygen may accumulate within the device s enclosure and pose a fire hazard Turning off the oxygen bef...

Page 18: ...face on the screen of the device as shown in Fig 11 6 Fig 12 6 If the SD card is inserted incorrectly a symbol indicating incorrect insertion will appear in the Main Interface on the screen of the device as shown in Fig 11 7 Fig 12 7 CAUTION If the SD card is not inserted there will not be a symbol in the Main Interface on the screen of the device To avoid data loss or any damage to the SD card th...

Page 19: ...r severe headache when using the device contract your physician or qualified medical personnel immediately 13 Routine Use 13 1 Connecting the Tube Connect the power cord power adapter and tube properly according to the instructions in the First Time Setup Chapter 12 Connect the mask and headgear according to the user manual for the mask CAUTION Before each use examine the tube for any damage or de...

Page 20: ... as you wish during sleep The ramp feature is not prescribed for all users 13 6 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 CAUTIONS Do not position the device where it is difficult to disconnect the device To isolate the device from the ...

Page 21: ...n in Fig 14 3 Make sure that the water does not exceed the maximum water level line Fig 14 2 Fig 14 3 WARNING Change water before every 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 14 1 3 Inserting the Water Chamber Close the cap after it is filled with water as shown in Fig 14 4 and return it to t...

Page 22: ...ather than remain in the tubing causing rainout CAUTIONS Avoid moving or tilting the device when the water chamber has water in it Take precautions to protect furniture from water damage 14 2 Emptying the Water Chamber 1 Removing the water chamber according to instructions in 14 1 1 2 Emptying the water chamber Open the cap as shown below and pour any remaining water out of the water chamber Fig 1...

Page 23: ...lights light up when the humidity is adjusted to Level 3 as shown in Fig 13 7 Humidifier Indicator Fig 14 7 CAUTIONS Generally speaking the humidity inside the mask is low when the water temperature is low The greater the difference between the temperature inside the air tubing and room temperature is the more easily condensation occurs inside the tubing If there are only a few condensed water dro...

Page 24: ... the Initial Setup Interface From the Main Interface shown in Fig 15 1 or Fig 15 2 press and hold the Ramp Button for three seconds The screen displays the Initial Setup Interface of the Patient Menu as shown in Fig 15 3 Fig 15 3 The first icon on the left side of the screen indicates the Main Interface the second icon indicates the Initial Setup Interface and the third icon indicates the iCode In...

Page 25: ...option press the Knob and the option is then displayed in yellow meaning that the option can now be adjusted as shown by the Humidifier option in Fig 15 5 Fig 15 5 15 1 5 Adjusting Options Adjust the option by turning the Knob As shown in Fig 14 5 the Humidifier option is selected As you turn the Knob clockwise the numbering increases indicating a higher humidity level As you turn the Knob counter...

Page 26: ... turn the Knob clockwise as shown in Fig 15 8 Fig 15 8 Note are page turning symbols 15 1 8 Exiting the Patient Menu 1 Returning to the Initial Setup Interface Move the cursor to the Back option by turning the Knob as shown in Fig 15 9 Fig 15 9 Press the Knob the cursor jumps to the second icon on the left side of the screen The screen displays the Initial Setup Interface as shown in Fig 15 10 Fig...

Page 27: ... the Main Interface Move the cursor to the Home option by turning the Knob as shown in Fig 15 11 Fig 14 11 Press the Knob to exit the Patient Menu The screen will display the Main Interface shown in Fig 15 1 or Fig 15 2 24 Luna II QX CPAP Luna II QX Auto CPAP User Manual V1 1 ...

Page 28: ...ted As you turn the Knob to the nearest point the numbering increases or decreases by five minutes The default setting is 10 minutes The screen displays a real time countdown of the remaining ramp time in minutes Delay On Off When the humidifier is on this feature allows the airflow to continue for about 15 minutes at a low pressure about 2 cmH2O after you press the Knob to discontinue treatment T...

Page 29: ...rs when the device is in standby state 2 No alert message on the screen during a power failure Device Fault An audible alert will sound if no airflow comes out of the machine the screen will display Device Fault Leak When the airflow is on an audible alert will sound in 40 s if the air leak rate is excessive the screen will display Leak Low Input Voltage If the voltage supplied by power adaptor is...

Page 30: ...tient 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 CAUTIONS Overheating of the materials could lead to early fatigue of these materials Do not use solutions containing chlorinated lime chlorine or aromat...

Page 31: ... down to room temperature before removing it from the device CAUTIONS Clean the water chamber only after the water in it cools Make sure that no water 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 d...

Page 32: ...er and filter cap device must be unplugged 18 Traveling with the Device CAUTIONS Empty the water chamber before packing the device for your trip in order to prevent 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 th...

Page 33: ...ncy documents you can prove to them that it is a medical device 4 Security Stations For convenience at security stations there is a note on the bottom of the device stating that it is medical equipment It may be helpful to bring this manual along with you to help security personnel understand the device 30 Luna II QX CPAP Luna II QX Auto CPAP User Manual V1 1 ...

Page 34: ...r attempt to open the enclosure of the device Repairs and adjustments must be performed by 3B medical Inc authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage If necessary contact your local authorized dealer or 3B medical Inc for technical support and documents 20 Technical Support For technical support please contact your de...

Page 35: ...and throat dryness Use a chin strap to prevent 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 mar...

Page 36: ...rding to the patient s conditions and cannot treat sleep apnea if the treatment pressure is set too low It takes a maximum of four weeks to adapt to pressurized air Relax and breathe through the nose If the problem still exists contact your physician Obstructive sleep apnea symptoms recur Probably because the patient sleeps with his or her mouth open and the pressurized air goes out via the mouth ...

Page 37: ...mask or pressure sensing tube 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 16 6 Replacing the Air Filter and clean the air inlet Make sure the air inlet is unblocked The treatment pressure has been changed accidentally Contact your physician When the...

Page 38: ...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 network that supplies buildings...

Page 39: ...ne 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 and 315 0 UT 1 cycle 70 UT 25 30 cycle At 0 ...

Page 40: ...nded 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 not apply in all situations...

Page 41: ...utput 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 reflection from structures object...

Page 42: ...ency 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 RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may ...

Page 43: ...repair or replace at its option the defective material or part 3B medical Inc will pay customary freight charges from 3B medical Inc 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 3B medical Inc DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS LOSS OF PROFITS OVERHEAD OR CONSEQUENTIAL DAMA...

Page 44: ...www 3Bproducts com 3B 0519 3902 LUNA II QX ...

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