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BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 15 OF 44

  

3.5  GENERAL SAFETY INFORMATION AND PRECAUTIONS 

3.5.1 

GENERAL CAUTIONS 

 

  Personnel  operating  the  system  must  read  this  manual  thoroughly  and  become 

familiar with all its safety requirements and operating procedures prior to use of the device.  
 

  The BTL Vanquish ME system is not intended for use in wet environmental conditions. 

  Keep the equipment out of the reach of children. 

  The  BTL  Vanquish  ME  system  should  only  be  repaired  by  BTL  authorized  service 

personnel. 

  The  BTL  Vanquish  ME  system  should  be  transported  and  stored  in  temperatures 

between  
-10 °C to +55 °C (+14 °F to +131 °F) to prevent damage to the device or its components. 

  The unit, applicator and cables may not be sterilized using steam or gas. 

  Make sure all operators are familiar with the BTL Vanquish ME system’s controls. 

  Improper  installation,  operation  or  maintenance  of  the  BTL  Vanquish  ME  system  may 

result in malfunctions of this unit or other devices. 

  The BTL Vanquish ME system console has a touch screen. Do not use sharp objects or 

ballpoint  pens  to  operate  the touch  screen.  A  special,  soft  tip  stylus  is  provided  for  this 
purpose.  Alternatively,  the  user  may  use  their  fingers  to  operate  the  touch  screen 
buttons. 

  Malfunction  of  the  system  could  result  in  an  unintended  increase  of  power  output  and 

unintended  injury  to  the  patient.  If  the  system  shows  any  deviations  from  a  normal 
operating  situation,  discontinue  use  and  report  the  fault  to  BTL  authorized  service 
personnel. 

  Accessories that are not manufactured by BTL for use with the BTL Vanquish ME system 

must  not  be  attached  to  the  system  to  prevent  potential  harm  to  the  patient  and/or 
damage to the unit.  

  Avoid the use of liquids in the immediate vicinity of the system. Any liquid spilled onto the 

cabinet  may  cause  serious  damage  to  the  system’s  internal  components.  Never  spray 
aerosol cleaners directly onto the system.  

  Do not cover the cooling vents to avoid the equipment overheating. 

  Keep the applicator and its cables separated during treatment. Applicator or its cables in 

contact with each other during treatment could result in improper stimulation, skin burns, 
or damage to the cable or applicator. Do not cross cables. 

  Do not let the cable touch the applicator during the treatment. 

  Remove the applicator by pulling the cable connector only. Do not remove by pulling the 

cable. To remove the cable from the applicator, make certain the power is off. Hold the 
applicator while removing the cable to prevent the applicator from dropping to the floor. 

  Inappropriate handling of the accessories may adversely affect their characteristics. 

  Use of controls or adjustments or performance of procedures other than those specified 

in this manual may result in hazardous exposure to electromagnetic energy. 

  You should never, under any circumstances, attempt to hold the applicator in your hands 

during therapy. 

Summary of Contents for VANQUISH ME

Page 1: ...BTL VANQUISH ME OPERATOR S MANUAL...

Page 2: ...e as possible to our customer s needs Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line Wh...

Page 3: ...LOCATION FOR THE UNIT 17 3 7 PROTECTION OF THE UNIT 18 4 SYSTEM DESCRIPTION 19 4 1 THE FRONT PANEL OF THE BTL VANQUISH ME 19 4 2 THE BTL VANQUISH ME APPLICATORS 20 4 3 THE REAR PANEL OF THE BTL VANQU...

Page 4: ...generation Easy to use color touch screen allows for maximum operator comfort A large control knob is provided to increase and decrease output power The BTL Vanquish ME system is placed in a speciall...

Page 5: ...BTL VANQUISH ME OPERATOR S MANUAL I PAGE 5 OF 44 1 4 DEVICE LABELS Device labels are attached on the rear side of the unit The labels attached on the applicators...

Page 6: ...ields on unborn life have not yet been sufficiently researched we recommend that pregnant persons are not within 45 feet of the applicator when the unit is activated Before operating the unit each tim...

Page 7: ...d overheating the tissue Speak with the patient to verify that The patient is in a comfortable position during the entire treatment The patient is not in contact with the unit the applicator cable the...

Page 8: ...be misdirected and heating may be occurring in an unwanted area Internal burns can occur with the incorrect application of BTL Vanquish ME due to excessive intensity and or excessive exposure time The...

Page 9: ...ollow the increase in metabolic demand and tissue necrosis might result BTL Vanquish ME must not be applied Over eyes testes head and neck Over the pelvic or low back area when an IUD is present Over...

Page 10: ...sed blood flow may not meet the increased metabolic demand placed on the tissues by the thermal energy dose Always start with a low dose and observe patient response Increase in dose may be made in su...

Page 11: ...ents or accessory elements must be stored in their original packaging in a dry place Do not store or operate the unit in a dusty environment Do not immerse it in any liquid Do not place it near runnin...

Page 12: ...quish ME device and its parts Never use cleaning agents containing alcohol ammonia benzine thinners etc Never use abrasive cleaning materials which will scratch the device s surfaces In order to preve...

Page 13: ...e following areas of potential damage Touch screen display Patient Safety Switch It is the responsibility of the health care facility to verify that the unit complies with the facility local and natio...

Page 14: ...D General Warning Sign Non ionizing Radiation Type BF Applied Part Follow Instructions for Use Name and Address of the Manufacturer Date of Manufacture Serial Number Prescription Use Only Caution US F...

Page 15: ...patient If the system shows any deviations from a normal operating situation discontinue use and report the fault to BTL authorized service personnel Accessories that are not manufactured by BTL for u...

Page 16: ...5 4 ELECTROMAGNETIC ENERGY OPERATIONAL SAFETY Allow access to the treatment room only to personnel who have been well trained in the required safety procedures Do not operate BTL Vanquish ME system t...

Page 17: ...tment area during therapy No one wearing a cardiac pacemaker should be within 45 feet of an operating BTL Vanquish ME 3 6 SELECTING APPROPRIATE LOCATION FOR THE UNIT Observe the following instructions...

Page 18: ...akers in the rooms where the BTL Vanquish ME therapy is applied 3 7 PROTECTION OF THE UNIT Improper installation operation or maintenance of the BTL Vanquish ME system may result in malfunctions of th...

Page 19: ...1 THE FRONT PANEL OF THE BTL VANQUISH ME 1 touch screen display 2 select knob to select individual parameters 3 enter key 4 esc key 5 start stop key to start and stop therapy 6 on off switch back lit...

Page 20: ...BTL VANQUISH ME OPERATOR S MANUAL I PAGE 20 OF 44 4 2 BTL VANQUISH ME APPLICATOR 8 applicator 686 x 192 x 105 27 x 7 6 x 4 1 in 8...

Page 21: ...power switch 11 articulated arm 12 ventilation 13 connectors for the connection of applicator 14 voltage switch 115 V 230 V 15 two fuses 16 connector for the mains cable 17 applicator without connecti...

Page 22: ...plicator or their cables in contact with each other during treatment could result in improper stimulation skin burns or damage to the cable or applicator 4 4 PATIENT SAFETY SWITCH The therapy can be t...

Page 23: ...ger personal safety the unit must not be connected to the mains before inspection is complete When bringing the device from a cold environment into a warm one do not plug it into the mains until the d...

Page 24: ...ge switch 14 on the rear side of the device is set to the correct voltage For the voltage range of 100 120 V set the switch to the 115 position For the voltage range of 200 240 V set the switch to the...

Page 25: ...supported by the arm hold the applicator while removing the cable to prevent the applicator from dropping to the floor Tighten the arm so it does not move during therapy a Make sure that the arms are...

Page 26: ...BTL VANQUISH ME OPERATOR S MANUAL I PAGE 26 OF 44 c Attach the applicator cable to the applicator...

Page 27: ...MANUAL I PAGE 27 OF 44 d Connect the applicator cable to the unit The applicator is connected to connectors 13 on the rear side of the unit e To release the applicator from its holder press the applic...

Page 28: ...uch screen displays several graphic elements While some elements are for informative purposes only others can be pressed and activated Basic elements include push buttons informative text channel tab...

Page 29: ...ypad will be activated by pressing this button Typing the desired value and pressing enter will store the desired value and deactivate the numeric keypad Pressing esc will cancel the numeric keypad wi...

Page 30: ...hen applying BTL Vanquish ME to bandaged areas as long as the bandages are completely dry Check the patient for perspiration regularly Should you notice any signs of perspirations use a single layer o...

Page 31: ...he transformed energy but also the distance between applicator and skin is important for the subjective sensation of heat For best results place the applicator parallel to the skin s surface This will...

Page 32: ...again or press the continue button on the touch screen To stop the therapy press the esc button while in the pause mode By default the therapy ends after the set time elapses During the therapy you c...

Page 33: ...o the subjective response of the patient Refer to Dosage Levels as stated in the table below Dosage level Heat perception I lowest No perception of heat II low Slight warming mild perception of heat I...

Page 34: ...rapy interruption end of therapy etc All audio tones can be muted no sound or modified as required Edit individual audio schemes create new ones and modify audio tones for each operation The user crea...

Page 35: ...time restricted this submenu will indicate the date until when the device remains fully functional Unlock Code Time restrictions imposed on the use of the BTL Vanquish ME system operation can be remo...

Page 36: ...n this manual Standard accessories main power cord 2x spare fuses T6 3AL 250 V for 100 120 V 50 60 Hz stylus touch pen operator s manual arm with applicator cable for the connection of applicator cabl...

Page 37: ...o 120 V 200 V to 240 V Frequency 50 Hz to 60 Hz Electrical protection class Class I External exchangeable fuse 2 x T6 3 AL 250 V tube safety fuse 5 x 20 mm for supply voltage 100 V to 120 V 2 x T3 15...

Page 38: ...12 MHz Acceptable loads 10 to 1000 Maximum output voltage 240 V Adjustable values Treatment duration 1 to 45 min Mode continuous Output power 0 W to 200 W Note 1 The rated power is measured by means o...

Page 39: ...n order to check it for the intentional operation EMI problems should be reported to the manufacturer and to regulatory authorities GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS Th...

Page 40: ...ion distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference ma...

Page 41: ...5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupt...

Page 42: ...Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 3 5 P V1 80 MHz to 800 MHz d 3 5 P E1 800 MHz to 2 5 GHz d 7 P E1 0 01 0 12 0 12 0 23 0 1...

Page 43: ...es by BTL Industries Inc 47 Loring Drive Framingham MA 01702 Tel 866 285 1656 Fax 888 499 2502 E mail info btlnet com For service please contact service department at service btlnet com Date of last r...

Page 44: ...713 80MANUS201...

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