Magstim BiStim²
Operating Manual
© The Magstim Company Limited
1
MOP02-EN-02
SECTION 1 INTRODUCTION
1.1
Indications for Use
The Magstim Bistim² is a magnetic nerve stimulator intended for the stimulation of cortical and
peripheral nerves for diagnostic, research and therapeutic purposes.
The Magstim Bistim² consists of two Magstim 200² units and a Magstim Bistim² Connecting Module.
This enables the outputs of the two Magstim 200² units to output into a single stimulating coil either as
a single high energy pulse or as a pair of individual spaced pulses.
The Magstim Bistim² 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 Bistim² is intended for use by, or under the supervision of, a medical practitioner or
investigator and is 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 Bistim² is a non-sterile reusable medical device intended for multi-patient use. The
Magstim Bistim² is not intended to come into contact with the patient as this achieved through use of
a stimulating coil.
The Magstim Bistim² is intended to be stationary during use however, can be moved if necessary
when not in use.
The Magstim Bistim² should only be used on a conscious patient.
USA Only:
The Magstim BiStim² has not been cleared by the FDA for cortical stimulation.
Investigational uses require an IDE.
1.2
Contraindications
The Magstim Bistim² should not be;
used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted
medication pumps, cochlear devices, implanted defibrillators and/or implanted
neurostimulators
used on or in the vicinity of patients with implanted metal objects of a ferrous nature
used on patients where the skin in the area to be contacted is broken
used on patients who suffer from multiple sclerosis
used on those with large ischaemic scars
used on pregnant women
used on infants under the age of 2 years
Magstim rec
ommends 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).