MAGSTIM BiStim2 User manual

January 2014
Magstim BiStim²
Operating Manual
MOP02-EN
Revision 02

Magstim BiStim²
Operating Manual
© The Magstim Company Limited i MOP02-EN-02
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..................................................................................................... 2
1.4 Frequently Used Functions....................................................................................... 2
Section 2 Warnings and Precautions ................................................................................. 3
Section 3 Product Descriptions.......................................................................................... 5
3.1 Front Panel............................................................................................................. 5
3.2 Rear Panel.............................................................................................................. 9
3.3 Accessories .......................................................................................................... 10
Section 4 Operating Instructions...................................................................................... 11
4.1 Preparation ........................................................................................................... 11
4.2 Set-up................................................................................................................... 11
4.3 Connection............................................................................................................ 13
4.4 Operation.............................................................................................................. 14
4.5 Independent BiStim² Triggering (IBT)...................................................................... 15
Section 5 Maintenance ................................................................................................... 16
5.1 User Maintenance and Calibration.......................................................................... 16
5.2 Technical Maintenance.......................................................................................... 16
5.3 Voltage Selection and Fuse Rating......................................................................... 17
5.4 Cleaning and Disinfecting....................................................................................... 17
5.5 Servicing............................................................................................................... 17
5.6 Device Lifetime...................................................................................................... 17
5.7 Disposal................................................................................................................ 18
Section 6 Specifications.................................................................................................. 19
6.1 Safety Specifications.............................................................................................. 19
6.2 Technical Specifications......................................................................................... 20
6.3 Environmental Conditions ...................................................................................... 21
6.4 Handling ............................................................................................................... 21
6.5 Packing Instructions............................................................................................... 21
Section 7 Contact Details................................................................................................ 22
7.1 Product Enquiries.................................................................................................. 22
7.2 Servicing Enquiries................................................................................................ 22
7.3 Sales Enquiries ..................................................................................................... 22
Appendix A –SYSTEM ERROR CODES ............................................................................ 23
Appendix B –Trigger Input / Output .................................................................................... 25
Appendix C –MANUFACTURER’S EMC DECLARATIONS.................................................. 26

Magstim BiStim²
Operating Manual
© The Magstim Company Limited ii MOP02-EN-02
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 BiStim²
Operating Manual
© The Magstim Company Limited 1 MOP02-EN-02
SECTION 1 INTRODUCTION
1.1 Indications for Use
The Magstim Bistim² is a magnetic nerve stimulator intended for the stimulation of cortical and
peripheral nerves for diagnostic, research and therapeutic purposes.
The Magstim Bistim² consists of two Magstim 200² units and a Magstim Bistim² Connecting Module.
This enables the outputs of the two Magstim 200² units to output into a single stimulating coil either as
a single high energy pulse or as a pair of individual spaced pulses.
The Magstim Bistim² is capable of stimulating 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 Bistim² is intended for use by, or under the supervision of, a medical practitioner or
investigator and is 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 Bistim² is a non-sterile reusable medical device intended for multi-patient use. The
Magstim Bistim² is not intended to come into contact with the patient as this achieved through use of
a stimulating coil.
The Magstim Bistim² is intended to be stationary during use however, can be moved if necessary
when not in use.
The Magstim Bistim² should only be used on a conscious patient.
USA Only: The Magstim BiStim² has not been cleared by the FDA for cortical stimulation.
Investigational uses require an IDE.
1.2 Contraindications
The Magstim Bistim² should not be;
used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted
medication pumps, cochlear devices, implanted defibrillators and/or implanted
neurostimulators
used on or in the vicinity of patients with implanted metal objects of a ferrous nature
used on patients where the skin in the area to be contacted is broken
used on patients who suffer from multiple sclerosis
used on those with large ischaemic scars
used on pregnant women
used on infants under the age of 2 years
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).

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1.3 Devices Covered
This document is applicable to the following device:
Magstim Bistim² System
This consists of:
2 x Magstim 200² Unit (P/N: 3010-00)
Magstim Bistim² Connecting Module (P/N: 3330-00)
Footswitch (P/N: 9525-01)
Magstim Bistim² UI Controller (P/N: 3021-00)
Magstim 200² UI Controller (P/N: 3020-00)
All parts of the Magstim BiStim² system, referenced above are suitable for use within the patient
environment.
Note: When the Bistim² Connecting Module is not connected, the Magstim 200² Units will operate as
if they were a standalone device. Please consult the Magstim 200² Operating Manual before using the
Magstim 200² Units as standalone devices.
Magstim 200² stimulator - MOP01
Note: Please also consult any labelling and information accompanying stimulating coils and other
accessories for safety and use information regarding these devices.
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 BiStim² that frequently involve user
interaction.

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Operating Manual
© The Magstim Company Limited 3 MOP02-EN-02
SECTION 2 WARNINGS AND PRECAUTIONS
Attention Consult Operating Manual: Consult the operating manual before using this device.
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 the Magstim Bistim² System and its accessories
during operation and for up to 20 minutes following operation. Therefore:
do not remove covers. 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
and BiStim² connecting module.
Replace coil indicator*:The system monitors the coil temperature and if this reaches 40°C, the
stimulator will be disabled. The coil surface temperature may continue to rise after this point;
therefore, the coil must be removed from the subject as soon as the replace coil indicator is
illuminated.
Rear Panel Outputs*: Only equipment that meets the relevant IEC standard should be connected
to the Magstim Bistim².
This connection must be configured in compliance with IEC 60601-1-1:2000 or Clause 16 of IEC
60601-1:2005 (Second edition: IEC 60601-1-1) with the following interface voltage limitation: Max
signalling voltage +5.3V; Max voltage with respect to protective earth potential 30V peak
Magnetic Pulses: the system generates high intensity magnetic pulses through its coils, which
induce eddy currents in any conductive medium, such as the human body, nearby metallic objects
or electronic devices. Therefore, the system:
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 Magstim BiStim² System, or if any parts are
damp or wet, the system must not be used. If damaged, the Magstim BiStim² should be returned
to the Magstim Company Limited for servicing and repair (see Section 7.2 for contact details).

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Operating Manual
© The Magstim Company Limited 4 MOP02-EN-02
Explosive and Flammable Atmospheres: The Magstim Bistim² and accessories must not be
used in an explosive atmosphere, around explosive gases or in the presence of flammable
anaesthetics.
Protective Earth: To avoid the risk of electric shock, the Magstim Bistim² must only be connected
to a supply mains with protective earth.
Modification: No modification of this equipment is allowed.
Discharge noise: when the magnetic pulse is delivered, a discharge click is produced that may
startle. The use of ear protection is recommended.
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.
Stacking Limit: Magstim 200² units may be stacked on top of each other, but must not exceed
the stacking limit specified in Section 6 of this operating manual. If this limit is exceeded, the stack
may become unstable and overbalance risking injury to patients or users and risking damage to
the unit’s themselves.
If the stacking limit is reached it can have a weight of up to 80kg. Ensure that the surface upon
which to system is to be placed is capable of supporting this weight. Failure to do so may result in
injury or damage. The weight for each individual 200² unit is in excess of 20kg
Carrying*: On no account should the Bistim² connecting module be used as a carrying/gripping
point when transporting its host Magstim 200² unit. The Bistim² connecting module and its fixings
are not designed to be subjected to this level of force and the Bistim² connecting module will
become detached from its host unit. This could result in damage to Magstim 200² unit, Bistim²
connecting module, or those transporting the equipment
Connecting Equipment: Only equipment listed in Section 1.3 may be connected to the Magstim
BiStim². Equipment that meets the relevant IEC standard may be connected to the rear interface
ports at the rear of the Magstim Bistim². See Appendix B for further details.

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Operating Manual
© The Magstim Company Limited 5 MOP02-EN-02
SECTION 3 PRODUCT DESCRIPTIONS
3.1 Front Panel
The front panel, shown below, allows control of the Magstim Bistim² and provides the connection for
the stimulating coil.
Note: UI functions described in this section are to be performed on the master unit UI (Bistim² UI).
Control functions/buttons are not activated on the slave unit UI (200² UI) therefore cannot be used to
control system. The only function/button that may be used is the system stop button.
Figure 3.1: Detailed front panel
The upper unit is considered the master unit. The lower unit is considered the slave unit.
All operating functions described in this section assume that the mains power switches, located on
the rear panel of the master and slave units, are switched on.
3.1.1 On/Off Button* (1)
The on/off button toggles the master and slave units of the Magstim Bistim² between on and standby.
3.1.2 Armed Indicator* (2) & (9)
The armed indicator illuminates when the unit is armed allowing it to be triggered.
1
2
3
4
5
6
7
8
9
10
11
15
13
12
14
Master
Slave

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Operating Manual
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3.1.3 Power Indicator* (3)
The power indicator flashes when the Magstim Bistim² is in standby, and illuminates when the
Magstim Bistim² is on. When power is initially applied to the Magstim Bistim², the power indicator
should flash indicating the unit is in standby state.
3.1.4 Output Display* (4)
The output display consists of 3 lines. The first and second lines display the power output as a
percentage of maximum of the master and slave units respectively. The third line displays the inter-
pulse spacing. The default value displayed after initially switching on the master and slave units are
30% for both power outputs and 10ms for the inter-pulse spacing.
If an error code needs to be displayed, the power output is replaced by error code(s). These are
detailed in Appendix A –System Error Codes.
3.1.5 Coil Indicator* (5)
This green LED will illuminate if there is a coil detected as being connected correctly to the Magstim
Bistim².
3.1.6 Coil Temperature Indicators* (6)
These LED’s represent the surface temperature of the coil. The LED’s illuminate sequentially as the
coil temperature rises, beginning with the bottom green LED and ending with the amber LED. When
the amber LED is lit, it means that the coil is getting close to its maximum operating temperature. As
soon as it reaches its maximum operating temperature, the replace coil indicator will illuminate and
the Magstim Bistim² will disarm itself.
Note: If the temperature of the coil is below 5oC, the system will not operate. The Magstim Bistim²
will remain in its inactive default condition until it detects that the coil temperature has risen above
5oC.
3.1.7 Replace Coil Indicator* (7)
This red LED will illuminate if any of the following conditions are present:
1. The coil connected is not compatible with the Magstim Bistim².
2. The surface temperature of the connected coil has risen above its set limit.
3. The connected coil is faulty.
4. There is no coil connected.
If this LED is illuminated the Magstim Bistim² will not arm until the reason for the indicator being lit is
resolved.

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Operating Manual
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3.1.8 Disarmed Indicator* (8)
This LED is illuminated when the Magstim Bistim² has been put into its safe disarmed state.
3.1.9 Ready Indicator* (10)
When the Magstim Bistim² is armed, this LED will illuminated when the Magstim Bistim² is charged
and ready to be triggered.
3.1.10 Run Button* (11)
The Magstim Bistim² can be armed pushing the green run button. The Magstim Bistim² will charge to
the power level indicated on the output display. The Magstim Bistim² will not arm if the replace coil
indicator is illuminated.
3.1.11 Output Control* (12)
The output control allows the master power level, slave power level and inter-pulse spacing displayed
on the master unit UI to be adjusted. The master output power, slave output power and inter-pulse
spacing can be adjusted by rotating the output control clockwise to increases the level and rotating
anti-clockwise to decreases the level. To toggle between the master power, slave power and inter-
pulse spacing press the output control.
Each complete 360º rotation changes the master/slave power output level by approximately 20%.
3.1.12 Trigger Button* (13)
The Magstim Bistim² can be triggered to deliver the stimulus by pressing the yellow trigger button
along with one of the trigger buttons located on the coil. The instrument will continuously charge and
discharge if the trigger buttons are pressed and held.
3.1.13 System Stop Button* (14)
The Magstim Bistim² can be disarmed by pushing the red stop button. In this mode the disarmed
indicator will illuminate and the instrument will discharge internally.
Note: The Magstim Bistim² will disarm if the coil is disconnected, becomes faulty, the surface
temperature of the connected coil has risen above its set limit, the system stop button is activated, the
instrument detects an internal fault, or if the ready symbol has been illuminated for over 1 minute
without the instrument having been triggered.
3.1.14 Coil Output Socket* (15)
This socket is used to connect the stimulating coil to the Magstim Bistim² system.