MAGSTIM 2002 User manual

MAGSTIM®
MODEL2002
(PIN 3001-01)
With
Double 70mm
Remote Coil
(PIN 3190-00)
OPERATING MANUAL
BTL EX2027
Allergan v. BTL
PGR2021-00025

Magstim Model 2002
TABLE OF CONTENTS
Section 1:
Section 2:
Section 3:
Section 4:
Section 5:
Section 6:
Section 7:
Section 8:
Section 9:
Section 10:
Guarantee
Description
1.1 Introduction
1.2 Contraindications
1.3 Indications for Use
Warnings and Precautions
Front Panel Description
Rear Panel Description
Preparations for Use
Using the Magstim Model 2002
6.1 Description of the Coil
6.2 Discharging the Magstim
6.3 Recording
of Evoked Responses
Status Codes error Codes
Safety Features
8.1 Coil Temperature Protection
8.2 Coil Disconnection
8.3 Other Safety Measures
Maintenance and Servicing:
9.1 Voltage Selection and Fuse Rating
9.2 User Maintenance
9
.3 Technical Maintenance
9.4 Cleaning and Disinfecting
9.5 Servicing
9.6 Device Lifetime
9.7 Disposal
Specifications:
General Specifications
10.l Power
l0.2 Ambient Temperature Requirements
10.3 Capacitor Life Expectancy
10.4 Output
10.5 Rear Panel
10.6 General
10. 7 Handling
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Magstim Model 2002
GUARANTEE
Equipment manufactured by the Magstim Company Limited is fully guaranteed covering
materials and workmanship for a period
of one year from the date of shipment. The capacitor is
guaranteed for one year, or 200,000 discharges, which ever comes first. The Magstim Company
Limited reserves the right to perfonn guarantee services in its factory, at an authorised repair
station, or at the customer's installation.
The Magstim Company's obligations under this guarantee are limited
to repairs or, at the
company's option, replacement
of any defective parts of our equipment, except batteries, without
charge
if said defects occur during nom1al service.
Claims for damages during shipment must be filed promptly with the transportation company.
All correspondence concerning the equipment must specify both model name and/ or number
and serial number,
as it appears on the invoice for said equipment.
Improper use, mishandling, tampering with, or operation
of the equipment without following
specific operating instructions will void this guarantee and release the Magstim Company from
any further guarantee obligations.
The Magstim Company will only accept responsibility for
the effects on safety, reliability and
performance
of the equipment if:
modifications or repairs are carried out by persons authorised by The Magstim Company.
ii the electrical installation
of the relevant room complies with local regulations, and
iii the equipment is used in accordance with the instructions for use.
The Magstim Company Limited 3001-23-USA 1 August 24, 2006

Magstim Model 2002
SECTION 1: DESCRIPTION
1.1 INTRODUCTION
This manual is written for users of the Magstim Model 2002, an instmment used
in the magnetic stimulation
of neuromuscular tissue.
The Magstim Model 2002 is a device capable of stimulating neuromuscular tissue
by inducing small currents in the tissue using a brief pulse of electromagnetic
energy.
This method of stimulation enables deep, and otherwise inaccessible,
nerves to
be stimulated ea'iily and relatively painlessly. In addition, no skin
preparation
is required and stimulation can be achieved through clothing.
INDICATIONS :FOR USE
CAUTION
The Magstim Model 2002 is a magnetic nerve stimulator intended for the
stimulation
of peripheral nerves for diagnostic purposes.
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.
CONTRAINDICATIONS
Magstim Model 2002 and its accessories should not be used on or in the
vicinity
of patients or users with cardiac demand pacemakers, implanted
defibrillators and/or implanted neurostimulators.
The Magstim Company Limited 3001-23-USA 2 August 24, 2006

Magstim Model 2002
SECTION 2: WARNINGS AND PRECAUTIONS
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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
2002.
CAUTION: The Magstim Model 2002 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 2002, 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 2002 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 2002 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