Introduction; Indications For Use; Contraindications; Devices Covered - MAGSTIM MOP11-EN Operating Manual

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 M200
2
,
BiStim
2
,
Rapid
2
and
Rapid
2
Plus
1
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 Rapid
2
systems, M200
2
and BiStim
2
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 Rapid 2 stimulator - MOP03
• Magstim M200 2 stimulator - MOP01
• Magstim Bistim 2 stimulator - MOP02
© The Magstim Company Limited MOP11-EN-01