MAGSTIM 3190-00 User manual

FEB 2015
Magstim 2nd Generation Coils
Operating Manual
MOP04-EN
Revision 03

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited i MOP04-EN-03
TABLE OF CONTENTS
Table of Contents ................................................................................................................. i
Guarantee........................................................................................................................... ii
Section 1 Introduction....................................................................................................... 1
1.1 Indications for Use................................................................................................... 1
1.2 Contraindications..................................................................................................... 1
1.3 Devices Covered..................................................................................................... 1
1.4 Frequently Used Functions....................................................................................... 2
Section 2 Warnings and Precautions ................................................................................. 3
Section 3 Product Descriptions.......................................................................................... 5
3.1General................................................................................................................... 5
3.2 Double 70mm Remote Control Coil........................................................................... 5
3.3 Single 90mm Remote Control Coil and Single 90mm Standard Coil............................ 6
3.4 2nd Generation Coil User Interface ............................................................................ 6
Section 4 Operating Instructions........................................................................................ 9
4.1 Preparation ............................................................................................................. 9
4.2 Connection.............................................................................................................. 9
4.3 Operation.............................................................................................................. 10
4.4 Interlocks.............................................................................................................. 13
4.5 Error Codes .......................................................................................................... 13
Section 5 Maintenance ................................................................................................... 14
5.1 User Maintenance and Calibration.......................................................................... 14
5.2 Technical Maintenance.......................................................................................... 14
5.3 Cleaning and Disinfecting* ..................................................................................... 14
5.4 Servicing............................................................................................................... 14
5.5 Device Lifetime...................................................................................................... 14
5.6 Disposal................................................................................................................ 15
Section 6 Specifications.................................................................................................. 16
6.1 Safety Specifications.............................................................................................. 16
6.2 Technical Specifications......................................................................................... 17
6.3 Environmental Conditions*..................................................................................... 19
6.4 Packing Instructions............................................................................................... 19
Section 7 Contact Details................................................................................................ 20
7.1 Product Enquiries.................................................................................................. 20
7.2 Servicing Enquiries................................................................................................ 20
7.3 Sales Enquiries ..................................................................................................... 20
Appendix A - Error Codes................................................................................................... 21
Appendix B - TMS MEDICAL SCREENING QUESTIONNAIRE ............................................ 22
Appendix C - EMC IMMUNITY AND EMMISIONS ................................................................... 26

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited ii MOP04-EN-03
GUARANTEE
Equipment manufactured by The Magstim Company Limited is fully guaranteed, covering both
materials and workmanship, for a period of one year from the date of shipment. The Magstim
Company Limited reserves the right to perform guarantee services in its factory, at an authorised
repair station, or at the customer’s installation.
Any obligations which The Magstim Company Limited has under this guarantee are limited to repairs
or, should the company so choose, replacement of any defective parts of the equipment, except
batteries, without charge provided that the said defects occur during normal service.
Claims for damages during shipment must be filed promptly with the transportation company. All
correspondence concerning the equipment must specify the model name and/or number as well as
the serial number exactly as they appear on the invoice for the 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 Limited from any
further guarantee obligations.
The Magstim Company Limited will only accept responsibility for effects on safety, reliability and
performance of the equipment if:
modifications or repairs are carried out by persons authorised by The Magstim Company
Limited;
the electrical installation of the relevant room complies with local regulations; and
the equipment is used in accordance with the instructions for use.

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 1 MOP04-EN-03
SECTION 1 INTRODUCTION
1.1 Indications for Use
The Magstim 2nd Generation Coils are hand held accessories to the Magstim Rapid² systems, 200²
and Bistim² system 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.
The Magstim 2nd Generation Coils 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.
The Magstim 2nd Generation Coils are non-sterile reusable medical devices intended for multi-patient
use.
The Magstim 2nd Generation Coils are portable medical devices intended for limited patient
exposure. The coils are not intended to come into contact with any bodily fluids.
USA Only: 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.
USA Only: The Magstim 2nd Generation Coils have not been cleared by the FDA for cortical
stimulation. Investigational uses require an IDE
1.2 Contraindications
The Magstim 2nd Generation Coils are accessories to the Magstim Rapid² systems, 200² and Bistim²
system 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 and it should be read in conjunction with the
appropriate stimulator operating manual.
Magstim Double 70mm Remote Control Coil (P/N: 3190-00)
Magstim 90mm Remote Control Coil (P/N: 3192-00)
Magstim 90mm Standard Coil (P/N: 3193-00)

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 2 MOP04-EN-03
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 shown on the following page;
Magstim Rapid² stimulator - MOP03
Magstim 200² stimulator - MOP01
Magstim BiStim² stimulator - MOP02
1.4 Frequently Used Functions
Frequently used functions as defined during Magstim’s usability process are identified with
(*). Frequently used functions are functions of the 2nd Generation Coils that frequently involve
user interaction.

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 3 MOP04-EN-03
SECTION 2 WARNINGS AND PRECAUTIONS
Attention Consult Operating Manual: Consult the operating manual before using this device.
Ensure you are familiar with all sections of this operating manual prior to using the coil.
Operating Manual: Further information can be located in the operating manual.
Type BF Applied Part: Refer to Section 6.1 for further information.
High Voltages: High voltages are present in the2nd Generation Coils during operation. Therefore:
refer servicing to qualified personnel;
if there is any sign of external damage or if any parts are damp or wet, they must not
be used.
ensure that the system is disarmed prior to disconnecting the stimulating coil from the
stimulator.
Magnetic Pulses: The coils generate high intensity magnetic pulses, which induce eddy currents
in any conductive medium, such as the human body, nearby metallic objects or electronic devices.
Therefore, the coils:
must not be used on, or in the vicinity of subjects with cardiac demand pacemakers,
implanted defibrillators, or other electronic or metallic implants;
must not be used in a position where the current can be induced in cables or wires
that are directly connected to the subject;
must not be used in the vicinity of objects that are sensitive to magnetic fields, such as
watches, credit cards and electronic equipment; and
must not be used when in contact with metallic objects, as these objects may be
propelled or damaged by the magnetic field of the coil;
Damage: If there are any signs of damage to the Coils, or if any parts are damp or wet, the coil
must not be used*. If damaged, the coil should be returned to the Magstim Company Limited for
servicing and repair (see Section 7.2 for contact details).
Explosive and Flammable Atmospheres: The Magstim 2nd Generation Coils must not be used
in an explosive atmosphere, around explosive gases or in the presence of flammable
anaesthetics.
Modification: No modification of this equipment is allowed. On no account must either of the
multi-function buttons on the stimulating coil be permanently activated, by taping down, or any
other method of fixing. They are designed as a safety interlock, to disable them could result in a
serious injury as a result of an inadvertent discharge of the coil.
Surface Temperatures: The coil surface temperature will continue to rise following activation of
the stimulator’s coil over temperature function; therefore, the coil must be removed from the
subject as soon as the system indicates that the coil has reached maximum temperature.

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 4 MOP04-EN-03
Discharge noise: When the magnetic pulse is delivered, a discharge click is produced that may
startle. The use of ear protection is recommended for the operator and adult patients. Ear
protection is mandatory for children.
Seizures: cortical magnetic stimulation runs the risk of inducing seizures. Magstim concurs with
the advice given in the paper titled “Safety, ethical considerations and application guidelines for
the use of TMS in clinical practice and research” by Rossi et al (2009) in respect to screening
candidates prior to administering TMS.
Environmental Conditions*: The system must not be used or stored under environmental
conditions that fall outside those specified in section 6.3 of this operating manual.
Liquids: The Magstim 2nd Generation Coils must not be immersed in water, placed in an ice
bucket, or refrigerated; not even if first placed in a plastic bag. The coils do not have any
specialised protection against the ingress of liquids; conditions where ingress of liquid, or the
forming of condensation within the coil, can occur must be avoided, as the electrical insulation will
be compromised.

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 5 MOP04-EN-03
SECTION 3 PRODUCT DESCRIPTIONS
3.1 General
The coils have four main parts: the coil head, handle, cable and connector (as shown in Figure 3.1).
There is a copper winding in the coil head, through which energy from the stimulator is discharged.
The current that flows through the winding generates a magnetic field and a corresponding electrical
field (as shown in Section 6.2.1).
Figure 3.1: Example Coil illustration (3190-00 –D70mm Remote Control Coil)
3.2 Double 70mm Remote Control Coil
This coil has a figure-of-eight winding in the coil head. Current flow is in opposing directions in each
half of the coil, which is indicated by the current direction label (see Figure 3.2).
Figure 3.2: Double 70mm Remote Control Coil (P/N: 3190-00)
Coil cable
Coil connector
Coil handle
Coil head
Current direction
label

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 6 MOP04-EN-03
3.3 Single 90mm Remote Control Coil and Single 90mm Standard Coil
These coils have a single, circular winding in the coil head. Current flow is in one direction, which is
indicated by the current direction label (see Figure 3.4 & 3.5). The coils can be used on either side (A
or B), which allows the current direction to be changed when required by flipping the coil.
Figure 3.4: 90mm Remote Control Coil (P/N: 3192-00)
Figure 3.5: 90mm Standard Coil (P/N: 3193-00)
3.4 2nd Generation Coil User Interface
3.4.1 Remote control coils
Figure 3.6 shows the different parts of the remote control coils’ user interface and the descriptions
that follow explain their various functions.
Figure 3.6: User interface on a Remote Control Coil
4. Down Button
3. Ready Indicator
2. Stop Button
1. Multi-function
button
5. Multi-function
display
6. Up button
7. Temperature
indicator
Current
direction
label

Magstim 2nd Generation Coils
Operating Manual
© The Magstim Company Limited 7 MOP04-EN-03
3.4.1.1 Multi-function Button* (1)
Each remote coil has two multi-function buttons located on each side of its handle. These have the
following functions on all stimulators.
Charge the stimulator –engage and hold one of the buttons for two seconds.
Trigger the stimulator –engage both buttons at the same time (when the stimulator is
charged and ready). The stimulator will be triggered repeatedly if the two buttons are held
continuously. Note: the trigger function of these buttons will be disabled if they are being
held when the stimulator is charged.
They also have the following function on a Bistim² system.
Parameter selection –engage one of the buttons twice, in quick succession to change the
parameter indicated on the multi-function display.
Note: On no account must either of the multi-function buttons on the stimulating coil be permanently
activated, by taping down, or any other method of fixing. They are designed as a safety interlock, to
disable them could result in a serious injury as a result of an inadvertent discharge of the coil.
3.4.1.2 Stop Button* (2)
Engaging the stop button will place the stimulator into stopped mode; the stimulator will discharge
safely internally, without delivering a stimulus.
3.4.1.3 Ready Indicator* (3)
The ready indicator will be illuminated when the stimulator is charged and ready to deliver the
stimulus.
3.4.1.4 Down Button* (4)
When used with the Magstim 200² or Bistim² engaging the down button will reduce the selected
parameter by one unit. If the button is held, the parameter will continue to decrease until the button
is released or the minimum value is reached.
3.4.1.5 Up Button* (6)
When used with the Magstim 200² or Bistim² engaging the up button will increase the selected
parameter by one unit. If the button is held, the parameter will continue to increase until the button
is released or the maximum value is reached.
%
3.4.1.6 Multi-function Display* (5)
This display shows information regarding the system, which includes the following:
The stimulator output power (on a Magstim 200² and Rapid²)
The selected parameter (on a Magstim Bistim²)
An error code if a fault is detected by the system (see Appendix A)