MAGSTIM BiStim2 User manual

September 2011
Magstim Bistim2
Operating Manual
MOP02-EN
Revision
01
(€
0086
BTL EX2034
Allergan v. BTL
IPR2021-00312

TABLE OF CONTENTS
Magstim Bistim2
Operating Manual
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
Section 2 Warnings and Precautions .................................................................................3
Section 3 Product Descriptions..........................................................................................5
3.1 Front Panel .............................................................................................................5
3.2 Rear Panel..............................................................................................................8
3.3 Accessories ............................................................................................................9
Section 4 Operating Instructions...................................................................................... 10
4.1 Preparation ........................................................................................................... 10
4.2 Connection............................................................................................................ 10
4.3 Setup.................................................................................................................... 11
4.4 Operation .............................................................................................................. 12
4.5 Independent Bistim Triggering ................................................................................ 12
Section 5 Maintenance ...................................................................................................
13
5.1 User Maintenance and Calibration .......................................................................... 13
5.2 Technical Maintenance .......................................................................................... 13
5.3 Voltage Selection and Fuse Rating ......................................................................... 14
5.4 Cleaning and Disinfecting....................................................................................... 14
5.5 Servicing............................................................................................................... 14
5.6 Device Lifetime...................................................................................................... 14
5.7 Disposal................................................................................................................ 14
Section 6 Specifications..................................................................................................
15
6.1 Safety Specifications.............................................................................................. 15
6.2 Technical Specifications.........................................................................................
16
6.3 Environmental Conditions ...................................................................................... 17
6.4 Handling ............................................................................................................... 17
6.5 Packing Instructions............................................................................................... 17
Section 7 Contact Details................................................................................................ 18
7.1 Product Enquiries .................................................................................................. 18
7
.2 Servicing Enquiries................................................................................................ 18
7
.3 Sales Enquiries ..................................................................................................... 18
Appendix
A- Systrem Error Codes..................................................................................... 19
Appendix B - Trigger Input/ Output .................................................................................... 21
Appendix C - Manufacturer's EMC Declarations.................................................................. 22
© The Magstim Company Limited MOP02-EN-01

GUARANTEE
Magstim Bistim2
Operating Manual
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.
© The Magstim Company Limited ii MOP02-EN-01

SECTION 1 INTRODUCTION
1.1 Indications for Use
Magstim Bistim2
Operating Manual
The Magstim Bistim2 is a magnetic nerve stimulator intended for the stimulation
of cortical and
peripheral nerves for diagnostic and research 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 who has knowledge about the principles of TMS, physiology and potential side effects of
TMS.
Please note: Transcranial Magnetic Stimulation (TMS) has not been cleared by the FDA for cortical
stimulation. lnvestigational uses require an IDE.
1.2 Contraindications
The Magstim Bistim2 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.
Cortical magnetic stimulation runs the risk
of inducing seizures. Consideration should be given by the
medical practitioner prior to administering TMS to any patient who has large ischaemic scars, who
is
sleep deprived or who has a history of seizure or who has a any condition which predisposes them to
seizure.
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).
© The Magstim Company Limited MOP02-EN-01

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)
Magstim Bistim2
Operating Manual
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.
Note: Please also consult any labelling and information accompanying stimulating coils and other
accessories for safety and use information regarding these devices.
© The Magstim Company Limited 2 MOP02-EN-01

Magstim Bistim2
Operating Manual
SECTION 2 WARNINGS AND PRECAUTIONS
&
[!]
~
Attention: consult accompanying documentation before using the device(s).
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. 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.
Flammable Anaesthetics: The Magstim Bistim2 and accessories must not be used in an
explosive atmosphere or
in the presence of flammable anaesthetics.
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 standards and is configured in
compliance with EN 60601-1-1 should be connected to this output.
Caution: 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.
• must not be used if the Magstim Bistim2 or accessories have any external
damage, or
if any part is damp or wet.
Rear Panel Outputs: Only equipment that meets the relevant IEC standards and is configured in
compliance with EN 60601-1-1, should be connected to the Magstim Bistim2.
Discharge noise: when the magnetic pulse is delivered, a discharge click is produced that may
startle. The use
of ear protection is recommended.
© The Magstim Company Limited 3 MOP02-EN-01

Magstim Bistim2
Operating Manual
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.
Pregnancy: few medical papers
on the effects of magnetic stimulation on the unborn child/foetus
or the expectant mother are currently available. As a result, The Magstim Company Limited
is
unable to verify the safety of coil use on, or by, pregnant women. We recommend that anyone
wishing to use the coils on a pregnant woman, or to use it whilst pregnant, should contact The
Magstim Company Limited for more information.
Environmental Conditions: The system must not
be used or stored under environmental
conditions that fall outside those specified
in this operating manual.
Stacking Limit: Magstim Bistim2 Systems 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 Bistim2 System is in excess of 40kg.
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
© The Magstim Company Limited 4 MOP02-EN-01

Magstim Bistim2
Operating Manual
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.
Functions 4 to 14 are also available
on the Remote Control Coils and details can be found in
appropriate remote control coil operating manual.
1 2 3
Figure 3.1: Detailed front panel
4
'-
'
'
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 switch 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.
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.
© The Magstim Company Limited 5 MOP02-EN-01

0
0
3.1.4 Output Display (4)
Magstim Bistim2
Operating Manual
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.
NB If the temperature of the coil is below 5°C, 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 5°C
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.
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.
© The Magstim Company Limited 6 MOP02-EN-01

•
0
3.1.11 Output Control (12)
Magstim Bistim2
Operating Manual
The output control allows the power level displayed
on the power output display to be adjusted.
Rotating the control clockwise increases the power level. Rotating anti-clockwise decreases the
power level. Each complete 360° rotation changes the output level by approximately 20%.
3.1.12 TriggerButton(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.
Note: It is normal for the pin indicated on the label to protrude from the coil socket on the master and
slave stimulator units. This is an intentional design feature.
Figure 3.2: Coil output socket front view Figure 3.3: Coil output socket angled view
© The Magstim Company Limited 7 MOP02-EN-01