Magstim Alpha Coil Range
Operating Manual
SECTION 1 INTRODUCTION
1.1
Indications for Use
Coils from the Alpha Range are hand held accessories to the Magstim M2002, BiStim2, Rapid2 and
Rapid2 Plus1 magnetic stimulators, 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.
Coils from the Alpha Range 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.
Coils from the Alpha Range are non-sterile reusable medical device intended for multi-patient use.
Coils from the Alpha Range are portable medical devices intended for limited patient exposure. The
coils are not intended to
come
into contact with
any
bodily fluids.
USA Only: This device is not cleared by the FDA and is considered an investigational device.
lnvestigational devices require an IDE.
1.2 Contraindications
The Magstim Alpha range
of
coils are accessories to the Magstim Rapid2 systems, M2002 and BiStim2
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:
• D70° Coil (P/N: 4150-00)
•
D70a
(Coated) Coil (P/N: 4170-00)
Note: Please also consult any labelling and information accompanying stimulating coils and other
accessories for safety
and
use information regarding these devices. The stimulator operating manual
reference numbers are as shown;
• Magstim Rapid2 stimulator -MOP03
• Magstim M2002 stimulator -MOP01
• Magstim Bistim2 stimulator -MOP02
© The Magstim Company Limited MOP11-EN-01
