Introduction; Indications For Use; Contraindications; Devices Covered - MAGSTIM 3190-00 Operating Manual

SECTION 1 INTRODUCTION
1.1

Indications for Use

The Magstim 2
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
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
use.
The Magstim 2
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
stimulation. Investigational uses require an IDE
1.2

Contraindications

The Magstim 2
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)
© The Magstim Company Limited
nd
Generation Coils are hand held accessories to the Magstim Rapid² systems, 200²
nd
Generation Coils are intended for use by, or under the supervision of, a medical
nd
Generation Coils are non-sterile reusable medical devices intended for multi-patient
nd
Generation Coils are portable medical devices intended for limited patient
nd
Generation Coils have not been cleared by the FDA for cortical
nd
Generation Coils are accessories to the Magstim Rapid² systems, 200² and Bistim²
1
Magstim 2nd Generation Coils
Operating Manual
MOP04-EN-03