MAGSTIM RAPID2 Operating Manual page 4

Magstim Rapid
2 3576-23-09
SECTION: 1. WARNINGS AND PRECAUTIONS
USA Only
CAUTION: Magne.tic stimulation has not been cleared by the FDA for cortical stimulation.
Investigational human uses require that the use.r complies \Vith the. FDA regulations regarding
It1Yestigational Devices.
Please visit ww,v.fifa.gov/cdrh or ww,v.magstim-us.com fr,r more information.
CAUTION: In the USA, Federal Lav.- restricts this device to sale by or on the order of a practitioner
licensed by the lav.- of the State in \v-hich he/ she practices to use or order the use of the device.
Attention: Consult accompanying documentation before using the Magstim Rapid 2 .
CAUTION: The Magstim Rapid
2
and its stimulating coils 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 Rapid", 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 coils induce eddy currents in any
conductive medium such as the human body, nearby metallic objects or electronic devices.
l"'B Pm1icular 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 cmTents
being induced in them.
Caution: for safety reasons, do not leave patient cables attached to the MEP Pod if they are
not being nsed. If an unused cable is lefl: connected, and the patient is connected to the other
channel, there is the possibility that the unused cable may touch an earthed surface which
could allow current to flow through the patient to ground.
Caution: do not allow the coil or the coil cable to come into close proximity with the MEP
Pod patient cables. During discharge, current may be induced in these cables.
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 Rapid 2 must not be used in an explosive atmosphere or in the presence of
flammable anaesthetics.
\Vb.en the magnetic pulse is delivered, a discharge click is produced by the Magstim Rapid 2
and its stimulating coil. This discharge click may stm1le.
\1/here possible avoid the use of the stimulating coil near the ears. The use of ear plugs is
recommended.
High voltages are present within this System. Do not remove covers. Refer servicing to
qualified personnel. Ensure that the System is not subject to conditions where water/ liquid
may be tipped on it, including the UI Controller.
To emure grounding safety, all mains pov,,er connections should be made directly to wall
power outlet sockets. All of the customer's electrical cabling must conform to local electrical
standards. Do not use a terminal block if insufficient sockets are available, as this will form a
potential electrical hazard.
The Magstim Rapid
2 ,
its stimulating coil and accessories must not be used ifthere are any
signs of external damage or if any parts are damp or wet.
Cortical magnetic stimulation rnns the risk of inducing seizures.
The l\'IAGSTIM Company LTD November 2009