Device Description; What Is Tms; Indications For Use - MAGSTIM The Rapid2 Operating Manual

1.1 Device Description

The Magstim ® Rapid
stimulation using brief duration magnetic fields to induce electrical currents
directed at spatially discrete regions of the cerebral cortex. This method of cortical
stimulation, known as Magstim
Magstim ® TMS therapy, is a non-invasive effective treatment with few known
side effects + . Magstim
prescription only under the supervision of a licensed physician. The Magstim
Rapid 2 Therapy System can be used in both inpatient and outpatient settings,
including physician's offices, clinics, and hospitals.
®
The Magstim
intended for multi-patient use. Contact with the patient is achieved through use
of the stimulating coil. The Magstim
stationary during use, however the system can be moved when not in use.
+ Carpenter, L et al. Transcranial Magnetic Stimulation (TMS) for Major Depression: A multi-site,
naturalistic, observational study of acute treatment outcomes in clinical practice (2012)" Depress
Anxiety 2012: 29, 587-596.

1.2 What Is TMS?

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Magstim Transcranial Magnetic Stimulation (TMS), involves the production of
magnetic fields through an electromagnetic coil applied to the head. These
magnetic fields enter the brain unimpeded and induce a small electric current
in the targeted area of the brain.
Magstim ® TMS at rapid rates causes neuronal depolarization in the local brain
tissue under the stimulating coil which is associated with various physiological
changes in the brain similar to other depression therapies
++ Bahadir Bakim et al., The Combination of Antidepressant Drug Therapy and High-Frequency Repetitive Transcranial
Magnetic Stimulation in Medication-Resistant Depression, Bulletin of Clinical Psychopharmacology, Vol: 22, N.: 3, 2012.

1.3 Indications For Use

The Magstim Rapid² Systems are intended to be used for the stimulation
of peripheral nerves and the human cortex for therapeutic and diagnostic
use, including the treatment of major depressive disorders in adult patients.
Furthermore, they are intended to be used for the investigation of anatomy,
physiology and potential therapeutic effects.
The Magstim ® Rapid
the indications for use criteria, but do not meet any of the contraindications listed
in "2.1 Contraindications" on page 20. In all cases the patient should be in a
conscious state during treatment.
The Magstim ® Company Ltd.
2 Therapy System is a medical device that delivers magnetic
®
® TMS therapy should be used for patient treatment by
2
Rapid Therapy System is a non-sterile reusable medical device
2 Therapy System is intended to be used on adults who meet
'TMS' therapy, is explained more below.
® 2
Rapid Therapy System is intended to be
MOP16-EN-02
++ .
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