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BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 6 OF 44

  

2  TREATMENT SAFETY 

 
The information provided in this manual is not intended to replace the professional knowledge, 
experience,  and/or  training  of  the  healthcare  professional  regarding  the  clinical  use  of  the 
system.  
 

2.1  PATIENT AND OPERATOR SAFETY 

In  case  of  improper  or  unauthorized  use  of  the  unit,  the  operator, the  patient  or  other  persons 
may be subjected to the danger of electric shock due to high voltage produced by the unit, the 
danger of influence on active implantations by electromagnetic fields produced by the unit and 
the danger of being burned due to erroneously positioned applicator or false parameters such as 
the duration of treatment, power output or operating mode. 
 
Before  operating  the  unit,  please  read  this  Operator‘s  Manual  carefully  and  observe  the 
information contained therein. 
 
Refer  to  Contraindications  in  Chapter  2.2,  Precautions  in  Chapter  2.3  and  Safety 
Precautions
 in Chapter 3. 
 

 

Since  the  effects  of  high-frequency  fields  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 time, verify that: 
 

  The unit has been correctly connected to the mains. 

  The unit is freestanding and the patient is not in direct contact with metal objects such as 

heating radiators, metal beds, or other equipment. 

  The insulation of the RF output jack and applicator connection cables is not damaged. 

  The  applicator  connection  cable  is  connected  properly  and  is  not  cross-routed  (which 

may cause short circuits). 

  Only accessories (cables, applicator) approved by the manufacturer are connected. 

  The  patient  to  be  treated  and  the  personnel  have  removed  all  electric  devices  (e.  g. 

hearing  aids,  electrotherapy  electrodes,  mobile  telephones)  and  all  conductive  objects 
(e.g. rings, chains, watches, earrings or other jewelry, and eyeglasses) and that they are 
not in the immediate vicinity of the unit. 

  The  patient  is  in  a  composed  state  and  the  bodily  areas  to  be  treated  are  dry  on  the 

exterior. 

  There are no superfluous personnel in the room. 

  To test the Patient Safety Switch, follow the procedures listed in Chapter 4.4. 

 
 
 
 
 

Содержание VANQUISH ME

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 44: ...713 80MANUS201...

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