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Magstim 2nd Generation Coils 

 

 

Operating Manual 

 

 

© The Magstim Company Limited 

MOP04-EN-03 

SECTION 1  INTRODUCTION  

1.1 

Indications for Use 

The Magstim 2

nd

 Generation Coils are hand held accessories to the Magstim Rapid² systems, 200² 

and Bistim² system for the stimulation of cortical and peripheral nerves for diagnostic, research and 
therapeutic purposes. 

When  used  together,  they  are  capable  of  stimulating  neuromuscular  tissue  by  inducing  small 
currents in the nerve using a brief pulse of electromagnetic energy.  

This method of stimulation enables deep, and otherwise inaccessible, nerves to be stimulated easily 
and relatively painlessly. In addition, no skin preparation is required and stimulation can be achieved 
through clothing. 

The  Magstim  2

nd

  Generation  Coils  are  intended  for  use  by,  or  under  the  supervision  of,  a  medical 

practitioner  or  investigator  and  are  to  be  used  in  a  laboratory  or  a  medical  consulting  room 
environment. The medical practitioner or investigator should have knowledge about the principles of 
TMS, physiology and potential side effects of TMS.  

The Magstim 2

nd

 Generation Coils are non-sterile reusable medical devices intended for multi-patient 

use.  

The  Magstim  2

nd

  Generation  Coils  are  portable  medical  devices  intended  for  limited  patient 

exposure. The coils are not intended to come into contact with any bodily fluids. 

USA  Only:

  Federal  law  restricts  this  device  to sale  by  or  on  the  order  of  a  practitioner  licensed  by 

the law of the State in which he/she practices to use or order the use of the device. 

USA  Only:

  The  Magstim  2

nd

  Generation  Coils  have  not  been  cleared  by  the  FDA  for  cortical 

stimulation. Investigational uses require an IDE 

 

1.2 

Contraindications 

The Magstim 2

nd

 Generation Coils are accessories to the Magstim Rapid²

 

systems, 200² and Bistim² 

system  and  share  the  same  contraindications.  Please  see  the  appropriate  stimulator  operating 
manual.  
 
Magstim  recommends  that  a  standard  questionnaire  is  completed  to  screen  a  patient’s  suitability 
prior to using  any  Magstim product on that patient  and concurs  with the recommendations  given in 
the paper titled “Safety, ethical considerations, and application guidelines for the use of transcranial 
magnetic stimulation in clinical practice and research” by Rossi et al (2009). 

 

1.3 

Devices Covered 

This  document  is  applicable  to  the  following  devices  and  it  should  be  read  in  conjunction  with  the 
appropriate stimulator operating manual.  

 

Magstim Double 70mm Remote Control Coil (P/N: 3190-00) 

 

Magstim 90mm Remote Control Coil (P/N: 3192-00) 

 

Magstim 90mm Standard Coil (P/N: 3193-00) 

Содержание 3190-00

Страница 1: ...FEB 2015 Magstim 2nd Generation Coils Operating Manual MOP04 EN Revision 03...

Страница 2: ...nterface 6 Section 4 Operating Instructions 9 4 1 Preparation 9 4 2 Connection 9 4 3 Operation 10 4 4 Interlocks 13 4 5 Error Codes 13 Section 5 Maintenance 14 5 1 User Maintenance and Calibration 14...

Страница 3: ...ng normal service Claims for damages during shipment must be filed promptly with the transportation company All correspondence concerning the equipment must specify the model name and or number as wel...

Страница 4: ...Magstim 2 nd Generation Coils are portable medical devices intended for limited patient exposure The coils are not intended to come into contact with any bodily fluids USA Only Federal law restricts...

Страница 5: ...egarding these devices The stimulator operating manual reference numbers are shown on the following page Magstim Rapid stimulator MOP03 Magstim 200 stimulator MOP01 Magstim BiStim stimulator MOP02 1 4...

Страница 6: ...ced in cables or wires that are directly connected to the subject must not be used in the vicinity of objects that are sensitive to magnetic fields such as watches credit cards and electronic equipmen...

Страница 7: ...for the use of TMS in clinical practice and research by Rossi et al 2009 in respect to screening candidates prior to administering TMS Environmental Conditions The system must not be used or stored u...

Страница 8: ...at flows through the winding generates a magnetic field and a corresponding electrical field as shown in Section 6 2 1 Figure 3 1 Example Coil illustration 3190 00 D70mm Remote Control Coil 3 2 Double...

Страница 9: ...e current direction to be changed when required by flipping the coil Figure 3 4 90mm Remote Control Coil P N 3192 00 Figure 3 5 90mm Standard Coil P N 3193 00 3 4 2nd Generation Coil User Interface 3...

Страница 10: ...ty interlock to disable them could result in a serious injury as a result of an inadvertent discharge of the coil 3 4 1 2 Stop Button 2 Engaging the stop button will place the stimulator into stopped...

Страница 11: ...its handle The roles of the interlock buttons are to prevent inadvertent triggering of the system Note On no account must either of the multi function buttons on the stimulating coil be permanently a...

Страница 12: ...and to identify any cleaning required If any cracks are visible in the plastic covers or there is damage to the handle or cable the coil must not be used and should be returned to The Magstim Company...

Страница 13: ...is connected to the stimulator and ready to use remove the coil from the coil holder of the right hand side of the stimulator The coil will show the output power of the system on the multi function d...

Страница 14: ...the selected parameter to the desired level The parameter value will be displayed on the stimulator user interface 3 To select a different parameter engage one of the multi function buttons twice in...

Страница 15: ...ulator 8 Section 4 2 should be repeated in reverse to disconnect the coil Note Ensure that the system is disarmed prior to disconnecting the stimulating coil from the stimulator 4 3 4 Use of the Stand...

Страница 16: ...tion There is an automatic coil temperature interlock applied by the stimulator When the maximum temperature is reached the coil temperature indicator will be illuminated and the stimulator will retur...

Страница 17: ...further advice or to arrange a return see Section 7 2 for contact details Warning contact burning is communicable so any coil with damaged contacts will infect a stimulator with healthy contacts and v...

Страница 18: ...serviceable life it should not be disposed of in general waste The Magstim Company Limited should be contacted see Section 7 2 for contact details for advice on its disposal in compliance with the app...

Страница 19: ...rent limits as required by IEC 60601 1 The Magstim 2 nd Generation Coils comply with the requirements of Safety Standard IEC 60601 1 and with EMC Standard EN 60601 1 2 To avoid problems with EMC inter...

Страница 20: ...verage Inductance 15 50 H 23 47 H 23 47 H Coil Cable Length 2m 2m 2m Peak Magnetic Field 2 2T 2 0T 2 0T Max Number of Pulses 50 Power 340 50 Power 505 50 Power 505 80 Power 110 80 Power 260 80 Power 2...

Страница 21: ...imited 18 MOP04 EN 03 Figure 6 2 Approximate electric field profile for D70mm Remote Coil measured using a Magstim Rapid 6 2 2 Magnetic Field Plot Figure 6 3 Approximate Magnetic Field Profile for 90m...

Страница 22: ...If for any reason it is necessary to return your Magstim 2 nd Generation Coils care should be taken to ensure that the equipment is adequately packed to prevent transit damage Ideally the equipment s...

Страница 23: ...y Limited Spring Gardens Whitland Carmarthenshire SA34 0HR Telephone 44 0 1994 240798 Fax 44 0 1994 240061 E mail magstim info magstim com Website www magstim com 7 2 Servicing Enquiries Telephone 44...

Страница 24: ...fficient C10 Coil controller malfunction C11 Rapid coil algorithm constant checksum incorrect C12 Invalid enhanced power byte 1 s compliment comparison test failed C13 Average power checksum incorrect...

Страница 25: ...r had a fainting spell 4 Have you ever had severe i e followed by loss of consciousness head trauma 5 Do you have any hearing problems or ringing in your ears Advise earplugs must be worn as possible...

Страница 26: ...be passed on to any other third party I confirm that I have read and understood the questions above and that my answers are correct and complete to the best of my knowledge and belief PRINT NAME ____...

Страница 27: ...u have metal in the brain skull except titanium e g splinters fragments clips etc If the respondent answers yes or don t know do not administer TMS Have you had surgery in the last 12 months above the...

Страница 28: ...rgical procedure to your spinal cord If the respondent answers yes or don t know do not administer TMS Do you have spinal problems If the respondent answers yes or don t know do not administer TMS Hav...

Страница 29: ...tended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Magstim Rapid2 System can help prevent electromagnetic interference by...

Страница 30: ...dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip...

Страница 31: ...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 may occur in the vicinit...

Страница 32: ...work that supplies buildings used for domestic purposes Harmonic Emissions IEC 61000 3 2 Class B by equipment type Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and Manufactur...

Страница 33: ...imated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80...

Страница 34: ...or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip...

Страница 35: ...tion distance in metres 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 m...

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