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
Magstim Bistim2
Operating Manual
3.2 Rear Panel
D
Master
Figure 3.4: Blank Rear Panel
3.2.1 Power (1)
The Power switch allows the power supplying the unit to
be
switched
on
(labelled
I)
or off (labelled
0).
3.2.2 Isolated Interface (2)
The trigger input is used to synchronise the Magstim Bistim2 system to an external trigger input. This
is only functional
on
the master unit. Please see Appendix B for more information.
3.2.3 Foot Switch Socket (3)
This socket is used to connect the pneumatic foot switch to the Magstim Bistim2 system. The foot
switch can be used to trigger the instrument when one of the trigger buttons located on the coil
is
also pressed. The instrument will continuously charge and discharge if the trigger buttons are
pressed and held. The foot switch socket
is
only functional
on
the master unit when.
3.2.4 Cooling Fan Outlet (4)
With the Magstim Bistim2 turned
on,
air
is
drawn through slots at the bottom
of
the instrument and
expelled through the fan outlet. There should be no obstructions placed closer than 50mm to the fan
outlet.
© The Magstim Company Limited 8 MOP02-EN-01
3.2.5 Functional Earth (5)
Magstim Bistim2
Operating Manual
Functional earth connections
of
the master and slave units should be connected using the supplied
functional earth strap.
3.2.6 Power Entry Module & Fuse Access (6)
The standard IEC mains lead should be connected to the unit prior to the unit being switched on.
3.3 Accessories
A range
of
stimulating coils are available for use with the Magstim range
of
products. For more
details, please contact the Sales department. Contact details are shown in Section 7.3.
Please note, only "category A" high power stimulating coils will work with the Magstim Bistim2•
Please note: The use
of
the correct accessories is essential to the functioning
of
the Magstim Bistim2•
The Magstim Company Limited cannot guarantee the instrument's performance unless accessories
used are obtained from The Magstim Company Limited. Only Magstim accessories purchased from
the The Magstim Company Limited should be used with the Magstim Bistim2.
© The Magstim Company Limited 9 MOP02-EN-01
SECTION 4 OPERATING INSTRUCTIONS
Magstim Bistim2
Operating Manual
Note: to avoid problems with interference, the Magstim Bistim2 system should not be used in the
vicinity
of
any equipment not
in
compliance with the EMC Standard
EN
60601-1-2, including mobile
phones.
Note: Please ensure you are familiar with all sections
of
this operating manual prior to following these
operating instructions.
4.1
Preparation
1.
At the start
of
each session the operator must check the Magstim Bistim2 system and any
accessories used for any signs
of
external damage and to identify any cleaning required.
If
any
cracks are visible in the housing, or there
is
damage to any of the cables, the items must not
be
used and should
be
returned to The Magstim Company Limited for servicing and repair. If
cleaning is required, please follow the instructions
in
Section 5
of
this Operating Manual.
2.
Ensure that the master and slave units
of
the Magstim Bistim2 are switched off
on
the rear.
3. Remove the two blanking plugs from the threaded inserts on the left-hand side of the master unit.
4.
Insert the two M6x60 hexagon bolt into the mounting holes
on
the Bistim2 Connecting Module.
Place the Bistim2 Connecting Module against the side
of
the master unit so that the bolts locate
in
the threaded inserts. Ensure that the coil output socket
is
facing the front.
5.
Using the supplied hexagon key tighten the bolts so as to secure the Bistim2 Connecting Module
to the side
of
the master unit. Do not over tighten the bolts as this may damage the cases
of
the
units.
6. Fit the two supplied blanking inserts to the mounting holes
in
the Bistim2 Connecting Module.
These blanking plugs are a push fit but care
is
needed with the positioning
of
the inserts to ensure
that the tops are flush with the case surface
4.2 Connection
1.
Place the master unit on top
of
the slave unit ensuring the feet of the master unit fit into the
recesses
on
the slave unit.
2.
Connect the supplied earth strap between a functional earth connection
on
the master and slave
unit.
3. If a foot switch is to be used, insert the pneumatic connector of the foot switch to the rear panel
Foot Switch Socket on the master unit
of
the Magstim Bistim2 system.
4. If
an
external triggering
or
recording device is to
be
used, connect it to the Isolated Interface on
the rear
of
the master unit
of
the Magstim Bistim2 system. Refer to Appendix B for more details
on
the Isolated Interface.
© The Magstim Company Limited 10 MOP02-EN-01
Magstim Bistim2
Operating Manual
5.
Connect the lead marked "A" from the Bistim2 Connecting Module to the coil socket on the master
unit, connect the lead marked "B'' from the Bistim2 Connecting Module to the coil socket on the
slave unit and connect the stimulating coil to be used to the coil socket on the Bistim2 Connecting
Module.
Note: ensure the guidance below is followed.
There
is
locating key on the coil connector, which needs to be aligned with the corresponding
receptor on the stimulator coil socket. It is then possible to rotate the outer collar
of
the coil
connector
in
order to lock the coil to the stimulator.
Coil Stimulator socket receptor
Figure 4.1: Locating key
on
the coil connector (left) and the stimulator coil socket (right)
Care must be taken to attach the coil connector to the stimulator correctly (see Figure 4.2).
Failure to do so can cause damage to the connector pins and
in
severe cases, internal damage to
the coil and the stimulator.
Figure 4.2: Diagram showing correct and incorrect ways to connect the coil to the stimulator
6. Connect the power leads to the rear
of
the master and slave units.
4.3 Setup
1.
Set the power switch on the rear
of
the master and slave units to the on (I) position. The power
indicators will flash indicating that the units are
in
standby.
2.
Push the on/off button on the front
of
the master
ad
slave units. The power indicators will become
continuously lit. The Magstim Bistim2 System will start an initialisation sequence during which the
armed indicator will flash three times and LED's
in
the user interface will light sequentially.
Once the initialisation sequence is complete, the coil indicator and disarmed indicator LED's
should be lit and the output display should read 30% on the first line, 30% on the second line and
10ms on the third line.
Note: During the initialisation sequence, the operator must check that all LED's are lit. If they
do
not, the items must not be used and should be returned to The Magstim Company Limited for
servicing and repair.
© The Magstim Company Limited
11
MOP02-EN-01
Magstim Bistim2
Operating Manual
3.
Use the output control to adjust the power level or the inter-pulse spacing to the desired setting.
Depressing the output control will toggle the value being adjusted between the master power
output, the slave power output and the inter-pulse spacing.
4.
The inter-pulse spacing range can
be
change between 0-999ms and 0-99.9ms, when adjusting
the inter-pulse spacing, rotating the control knob clockwise several times until the display shows
the maximum inter-pulse spacing (999ms or 99.9ms). Press and hold the stop button
on
the user
interface and rotate the control knob clockwise at the same time. The display should revert to
either 1.0ms
or
1
Oms.
Turn off the Bistim system and then turn
on
again and the default inter-
pulse time displayed should be in the new range (1.0ms or 10ms).
4.4 Operation
1.
Press the green
run
button to arm the Magstim Bistim2. The armed indicators of both the master
and the slave system should light, and once the system
is
charged, the ready indicators will also
illuminate.
Note: If the system is not triggered within a minute of being armed,
it
will revert back to the
disarmed state and will need to be re-armed before continuing.
2.
Position the stimulating coil over the desired target.
3.
When ready to trigger the system, press and hold one
of
the switches located on the coil handle,
then press either the trigger switch on the Magstim Bistim2 user interface or the foot switch.
A clicking noise should be heard from both the stimulating coil and the Magstim Bistim2 system. If
the inter-pulse spacing
is
large enough, two clicks should
be
audible.
4.
When necessary, reposition the coil and/or modify the output power or inter-pulse spacing to suit
requirements for the next stimulus. Meanwhile, the stimulator will recharge and the ready
indicator will be illuminated when charging is complete.
5.
At the end
of
the session, use the stop button to discharge the stimulator internally and put it into
disarmed mode.
6. Sections 4.3 and 4.2 should be repeated in reverse to disconnect the Magstim Bistim2.
4.5 Independent Bistim Triggering
When the system
is
set in IBT Mode, triggering
of
the master unit does not automatically trigger
the slave unit, allowing an alternate, external trigger to be used via the isolated interface.
The output from the master unit
is
used to initiate a triggering window
in
the slave unit. This
allows the slave to be triggered externally any time between 1ms and 2s after the master has
been triggered. This external triggering can
be
achieved only via the isolated interface. When
in
IBT Mode, the slave cannot be triggered by the footswitch or the
UI
controller.
To set the Magstim Bistim2 System
in
!BT Mode, , with an inter-pulse spacing of zero. Then hold
down the UI stop button and rotate the power level knob anticlockwise. The bottom display
should show
an
"E".
NOTE: When
you
are in this mode you cannot adjust the inter-pulse timing.
7. The Magstim Bistim2 System will remain set
in
IBT Mode following power-down. It will only revert
to standard operation when its mode
is
actively reset. To reset to standard operation, select the
inter-pulse time window, hold down the stop button and rotate the control knob clockwise.
© The Magstim Company Limited 12 MOP02-EN-01
SECTION 5 MAINTENANCE
5.1
User Maintenance and Calibration
Magstim Bistim2
Operating Manual
There are no user maintenance
or
calibration requirements for the Magstim Bistim2 system and
accessories. However, it
is
important that they are checked for any sign of damage at the start of
each session. If any cracks are visible
in
the plastics, or
if
there is damage to any
of
the cables, the
items must not be used and should be returned to The Magstim Company Limited for servicing and
repair (see Section 7.2 for contact details).
5.2 Technical Maintenance
The contacts
in
the coil connector, Bistim2 Connecting Module and the stimulator coil socket should
be checked regularly for any signs
of
tarnishing or burning. Under conditions
of
exceptionally intense
use,
it
is
possible for localised heating to manifest itself
in
the connector, which causes damage to the
contacts. Continued use
in
this condition will eventually cause the contacts to deteriorate and loose
electrical connection, which will cause damage to the system.
Repair is a specialised procedure and can only be undertaken by The Magstim Company Limited or
an authorised service centre.
If
any pins show damage, however slight, contact The Magstim
Company Limited service department for further advice or to arrange a return (see Section 7.2 for
contact details).
Warning: contact burning is communicable, so any coil with damaged contacts will infect a stimulator
with healthy contacts and vice-versa. Therefore, if damage is noticed on any coil connector or
stimulator coil socket the entire system must not be used until all contacts are carefully examined and
repaired where appropriate. If this is not done thoroughly there is a risk that the cycle of pin damage
will continue.
Figure 5.1: Example
of
contact burning
© The Magstim Company Limited 13 MOP02-EN-01
Magstim Bistim2
Operating Manual
5.3 Voltage Selection and Fuse Rating
The Magstim Bistim2 system is preset at the factory to operate at 110V-120V or 220V-240V A.C., as
appropriate. The following are the fuse ratings for both the master and slave units:
Supply Voltage
110V-120V-
220V-240V-
Qty
2
2
Fuse Size
20 x 5mm
20 x 5mm
Rating
T10A 250V
T5A250V
T denotes timed or antisurge fuses. Fast acting fuses are not recommended.
The fuses may be changed by inserting the tip
of
a small blade screwdriver or similar tool into the slot
below the arrow to lever the retaining lip enabling the fuse tray to be pulled out. Replace the blown
fuse(s) with one
of
the correct rating and locate and push home the tray ensuring the retaining lip
clicks into place.
The voltage may be selected by removing the fuse tray, rotating the selector and replacing the cover.
A legend will indicate the voltage selected when the fuse cover is replaced.
Only replace fuses with those
of
the correct rating, and only operate the instrument with the
voltage selector set at the appropriate voltage. Failure to do
so
may cause serious damage to
the device(s).
5.4 Cleaning and Disinfecting
The Magstim Bistim2 system and accessories cannot
be
sterilised; therefore, do not allow them to
become contaminated with bodily fluids. They may
be
cleaned using an isopropyl-moistened cloth but
ensure that they have dried thoroughly before use.
5.5 Servicing
The Magstim Bistim2 contains no user serviceable parts. Servicing
of
Magstim Bistim2 system and
accessories must only be carried out by The Magstim Company Limited or one of its authorised
service centres. To arrange a return
or
for further information, contact the service department at The
Magstim Company Limited (see Section 7.2 for contact details).
5.6 Device Lifetime
5.7
'--~---·
bzr
~
The lifetime of the Magstim Bistim2 system
is
defined as being five years from the date of shipment.
The Magstim Company Limited will support the products for the duration of their lifetime.
Disposal
When a Magstim Bistim2 system or accessory reaches the end
of
its serviceable life, The Magstim
Company Limited should be contacted (see Section 7.2 for contact details) to arrange for its disposal
in
compliance with the appropriate environmental regulations.
© The Magstim Company Limited 14 MOP02-EN-01
SECTION 6 SPECIFICATIONS
6.1
Safety Specifications
Magstim Bistim2
Operating Manual
During use, the type
of
protection against electric shock provided by the Magstim Bistim2 system is
classified as Class
1.
The degree
of
protection against electric shock for applied part accessories
is
classified
as
Type BF
Applied Parts. This means that the Stimulating Coils are electrically isolated from the other parts
of
the equipment and meet Type BF leakage current limits as required by
BS
EN
60601-1.
The Magstim Bistim2 system and accessories comply with the requirements
of
Safety Standard
EN
60601-1 and with EMC Standard 60601-1-2.
To avoid problems with EMC interference, the Magstim Bistim2 and accessories should not be used
in
the vicinity
of
any equipment that does not comply with EMC Safety Standard
EN
60601-1-2,
including mobile phones. Any interface cable which connects the Magstim Bistim2 unit to an external
piece of equipment must
be
no more than 1.5m
in
length.
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.
The Magstim Bistim2 system and accessories are classified
as
IPX0 (Not Protected), as there is no
specialised protection provided against the ingress
of
liquids.
The Magstim Bistim2 system and accessories are not protected against flammable anaesthetic
mixtures. They are not suitable for use
in
the presence
of
a flammable anaesthetic mixture with air,
oxygen or nitrous oxide.
The mode
of
operation
of
the Magstim Bistim2 system and accessories is classified as continuous.
© The Magstim Company Limited 15 MOP02-EN-01
6.2 Technical Specifications
Stimulator Output
Output Range and Accuracy:
Stimulation Frequency:
Pulse Characteristics:
Inter-pulse Spacing:
0%-100%
of
Maximum
Voltage±
1%
0.25Hz in Bistim Mode
Magstim Bistim2
Operating Manual
0.50Hz at 01% to 49% Power Output
in
simultaneous discharge mode
0.33Hz at 50% to 75% Power Output
in
simultaneous discharge mode
0.25Hz at 76%
to
100% Power Output
in
simultaneous discharge mode
100µs rise time, 1ms duration
0 - 999ms
or
0-
99.9ms
Note: Magnetic field strength and maximum number of stimulations produced before coil exceeds
operating temperature are dependent on the stimulation coil being used. Please refer to the
appropriate coil operating manual.
Capacitor Life Expectancy
Life expectancy:
Isolated Interface
Logic High Voltage:
Max Voltage:
Logic Low Voltage:
Min Voltage:
2 x
10
6 discharges at 70% power level
8 x 105 discharges at 80% power level
4 x 105 discharges at 90% power level
2 x
10
5 discharges at 100% power level
>4.0V
5.3V
<0.8V
-0.3V
All voltages are with respect to GND.
Power Supply
Power:
Fuse(s):
General Specifications
Master and Slave Units:
Dimensions:
Weight:
Stacking limit:
Bistim2 Connecting Module:
Dimensions:
Weight:
Software
Controller Board Software:
UI
Controller Software:
110V-120V- 50-60Hz;
220V-240V- 50-60Hz;
100VA during standby
2000VA peak and 600VA average during discharge
2 x
T1
0A 20x5mm for
11
0V-120V-
2 x T5A 20x5mm for 220V-240V-
460mm x 160mm x 375mm
20.4kg
4 Units stacked on top
of
each other
135mmxx 81mm x 165mm
1.62kg
Version 1.9
(Software ref: 3056)
Version
1.1
(Software ref: 3026)
Please note: All specifications are subject to alteration.
© The Magstim Company Limited 16 MOP02-EN-01
6.3 Environmental Conditions
Transport and storage temperature:
Transport and storage relative humidity:
Operating temperature:
Operating relative humidity:
Atmospheric pressure:
6.4 Handling
-19°C to 60°C
10% to 80% (non-condensing)
5°C to 30°C
30% to 70% (non-condensing)
50kPa to 106kPa
Magstim Bistim2
Operating Manual
The master and slave units weigh in excess of 20kg. If it
is
necessary to move the units for any
reason, the weight must be distributed between at least two persons. Please see diagram below for
recommended manual handling methods. The master and slave units should be moved individually.
Note: The weight
of
Magstim Bistim2 unit
is
unevenly distributed with the right hand side
of
the unit
being considerably heavier than the left. Care should
be
taken when transporting the unit to ensure
that this heavier side
is
adequately supported.
Figure 6.1: Guidelines on lifting and lowering
6.5 Packing Instructions
If,
for any reason,
it
is
necessary to return your Magstim Bistim2 care should be taken to ensure that
the equipment
is
adequately packed to prevent transit damage. Ideally the equipment should be
returned
in
its original packing. If this or
an
adequate replacement is not available, replacement
shipping cartons can
be
obtained from the Magstim Company Limited.
The Magstim Bistim2 System must be completely disconnected before shipping, including removal
of
the coil holder and Bistim2 Connecting Module
on
the side
of
the master unit. Failure to do so is likely
to result
in
transit damage to the casing.
© The Magstim Company Limited 17 MOP02-EN-01
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