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SECTION 1 INTRODUCTION
1.1
Indications for Use
Magstim 200
2
Operating Manual
The Magstim 200
2
is a magnetic nerve stimulator intended for the stimulation of cortical and
peripheral nerves for diagnostic and research purposes. The Magstim 200
2
is intended for use by, or
under the supervision of, a medical practitioner only.
The Magstim 200
2
is capable of stimulating 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 200
2
is intended for use by, or under the supervision of, a medical practitioner or
investigator who has knowledge about the principles of TMS, physiology and potential side effects of
TMS.
USA Only: Transcranial Magnetic Stimulation (TMS) has not been cleared by the FDA for cortical
stimulation. lnvestigational uses require an IDE.
1.2
Contraindications
The Magstim 200
2
and its accessories should not be used on, or in the vicinity of patients or users
with cardiac demand pacemakers, implanted defibrillators and/or implanted neurostimulators.
Cortical magnetic stimulation runs the risk of inducing seizures. Consideration should be given by the
medical practitioner prior to administering TMS to any patient who has large ischaemic scars, who is
sleep deprived or who has a history of seizure or who has a any condition which predisposes them to
seizure.
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 device:
•
Magstim 200
2
System
This consists of:
•
Magstim 200
2
Unit (P/N: 3010-00)
•
Footswitch (P/N: 9525-01)
and may also consist of the following optional parts:
•
Magstim 200
2
UI Controller (P/N: 3020-00)
If a Magstim 200
2
UI Controller is not used, a remote control will need to be used.
Note: Please also consult any labelling and information accompanying stimulating coils and other
accessories for safety and use information regarding these devices.
© The Magstim Company Limited
MOP01-EN-01
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