Warnings And Precautions - MAGSTIM 2002 Manual

Magstim Model 200
2
SECTION 2: WARNINGS AND PRECAUTIONS
n
~g_~ ~--~
,;1(;·
t •
411
•
CAUTION: Magnetic Stimulators have not been cleared by the FDA for
cortical stimulation. Investigational human uses require that the user complies
with the FDA regulations regarding Investigational Devices. Please visit
www.fda.gov/cdrh or www.magstim-us.com for more infomrntion.
CAUTION: 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.
Attention: Consult accompanying documentation before using the Magstim
200
2
.
CAUTION: The Magstim Model 200
2
and its stimulating coil must not be
used on, or in the vicinity of, patients or subjects with cardiac demand
pacemakers, implanted defibrillators, or other electronic implants.
The Magstim Model 200
2
,
its coils and accessories generate high intensity
magnetic pulses. The induced eddy current is of sufficient magnitude to
stimulate nerves and muscle.
The strong magnetic pulses generated by stimulating coil induce eddy currents
in any conductive medium such as the human body, nearby metallic objects or
electronic devices.
NB Particular care must be taken to ensure that leads connected directly to the
patient, or other equipment, are not in a position where the stimulating coil can
couple resulting in currents being induced in them.
Do not discharge the Magstim with the stimulating coil in the vicinity of
metallic objects or these may be projected, moved and/or damaged.
The Magstim Model 200
2
must not be used in an explosive atmosphere or in
the presence of flammable anaesthetics.
When the magnetic pulse is delivered, a discharge click is produced by the
Magstim 200
2
and its stimulating coil. This discharge click may startle.
Where possible avoid the use of the stimulating coil near the ears. The use of
ear plugs is recommended .
High voltages are present within this instmment. Do not remove covers. Refer
servicing to qualified personnel.
The Magstim Company Limited 3001-23-USA 3 August 24, 2006