MAGSTIM MOP11-EN User manual
October 2012
Magstim Alpha Coil Range
Operating Manual
MOP11-EN
Revision
01
CE
0086
BTL EX2033
Allergan v. BTL
PGR2021-00023
TABLE OF CONTENTS
Magstim Alpha Coil Range
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 ..................................................................................2
Section 3 Product Descriptions ..........................................................................................4
3.1
General...................................................................................................................4
3.2 User Interface..........................................................................................................5
Section 4 Operating Instructions .......................................................................................6
4
.1
Preparation .............................................................................................................6
4.2 Connection..............................................................................................................6
4.3 Operation ................................................................................................................7
Section 5 Maintenance......................................................................................................8
5.1
User Maintenance and Calibration ............................................................................8
5.2 Technical Maintenance ............................................................................................8
5.3 Cleaning and Disinfecting.........................................................................................8
5.4 Servicing.................................................................................................................9
5.5 Device Lifetime........................................................................................................9
5.6 Disposal..................................................................................................................9
Section 6 Specifications .................................................................................................. 10
6.1
Safety Specifications.............................................................................................. 10
6.2 Technical Specifications......................................................................................... 10
6.3 Environmental Conditions ...................................................................................... 13
6.4 Packing Instructions............................................................................................... 13
Section 7 Contact Details ................................................................................................ 14
7
.1
Product Enquiries .................................................................................................. 14
7
.2
Servicing Enquiries................................................................................................ 14
7.3 Sales Enquiries ..................................................................................................... 14
Appendix A - Error Codes ................................................................................................... 15
A
1.
Coil Error Codes.................................................................................................... 15
© The Magstim Company Limited MOP11-EN-01
GUARANTEE
Magstim Alpha Coil Range
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 said equipment.
Improper use, mishandling, tampering with, or operation
of
the equipment without following specific
operating instructions will void this guarantee and release The Magstim Company 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
MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
SECTION 1 INTRODUCTION
1.1
Indications for Use
Coils from the Alpha Range are hand held accessories to the Magstim M2002, BiStim2, Rapid2 and
Rapid2 Plus1 magnetic stimulators, 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.
Coils from the Alpha Range 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.
Coils from the Alpha Range are non-sterile reusable medical device intended for multi-patient use.
Coils from the Alpha Range are portable medical devices intended for limited patient exposure. The
coils are not intended to
come
into contact with
any
bodily fluids.
USA Only: This device is not cleared by the FDA and is considered an investigational device.
lnvestigational devices require an IDE.
1.2 Contraindications
The Magstim Alpha range
of
coils are accessories to the Magstim Rapid2 systems, M2002 and BiStim2
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:
• D70° Coil (P/N: 4150-00)
•
D70a
(Coated) Coil (P/N: 4170-00)
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 as shown;
• Magstim Rapid2 stimulator -MOP03
• Magstim M2002 stimulator -MOP01
• Magstim Bistim2 stimulator -MOP02
© The Magstim Company Limited MOP11-EN-01
SECTION 2
Magstim Alpha Coil Range
Operating Manual
WARNINGS AND PRECAUTIONS
Caution
Consult accompanying documentation before using the coil.
Type
BF
Applied Part: Refer
to
Section
6.1
for further information.
High Voltages: High voltages are present in the Alpha coils during operation. 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.
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;
• 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; and
• must not be used if the Alpha coils have any external damage, or if any part is damp
or wet.
Explosive and Flammable Atmospheres: The Magstim Alpha 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.
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.
Discharge noise: When the magnetic pulse
is
delivered, a discharge click
is
produced that may
startle. The use
of
ear protection by the patient and operator is recommended. If any protocol
is
being delivered at a power level above 70%, the use
of
ear protection by the patient is required.
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.
© The Magstim Company Limited 2 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
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 does
not recommend the use
of
magnetic stimulation on or near anyone who is pregnant, and
by
anyone who is pregnant.
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 Alpha coils must not be immersed
in
water, placed
in
an
ice bucket, or refrigerated;
not even
if
first placed in a plastic bag. The coil does 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. Cooling must
only be performed using a flow
of
cool air from a fan or air conditioning unit.
© The Magstim Company Limited 3 MOP11-EN-01
SECTION 3
3.1
General
Magstim Alpha Coil Range
Operating Manual
PRODUCT DESCRIPTIONS
The coil has four main parts: the coil head, handle, cable and connector (as shown
in
Figure
3.1
).
I i
Figure 3.1: Illustration showing main parts of Alpha coils (D70" shown
in
this example}
3.1.1 D70° and D70° (Coated) Coils
These coils (as shown
in
Figure 3.2a and Figure 3.2b) have a figure of eight shape winding
in
the coil
head. Energy is discharged through this copper winding when the stimulator
is
triggered. The current
that flows through the winding generates a magnetic field and a corresponding electrical field (see
figures in Section 6).
Figure 3.2a D70° Coil Figure 3.2b D70° (Coated) Coil
© The Magstim Company Limited 4 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
Current flow is
in
opposing directions
in
each half
of
the coil, which
is
indicated
in
Figure 3.3. The
stimulation face is that with no Alpha logo
or
current direction labels.
Figure 3.3: Direction
of
current flowfor both D70° and D70"(Coated) Coils
3.2 User Interface
Figure 3.4 shows the
D70a
and D70° (Coated) user interface and the descriptions that follow explain
their various functions.
Figure 3.4: User interface on a D70" Coil
3.2.1 Interlock Buttons (Coil Switches)
The coil has two interlock buttons located
on
its handle. The roles
of
the interlock buttons are to
prevent inadvertent triggering
of
the system.
On
no
account must the interlock buttons
on
the
stimulating coil be permanently activated, by taping down, or any other method of fixing. Disabling
them could result
in
a serious injury as a result of an inadvertent discharge
of
the coil.
3.2.1.1 Magstim 2002 & Bistim2
In
order to trigger the system at least one interlock button must
be
pressed
in
conjunction with
either the footswitch
or
yellow trigger button
on
the stimulator user interface.
3.2.1.2 Rapid2 & Rapid2 Plus1
With the "coil switch option" turned off (refer to Magstim Rapid2 user manual, MOP03-EN) at least
one interlock button must be pressed
in
conjunction with either the footswitch or yellow trigger
button on the stimulator user interface.
With the "coil switch option" turned on, each time the system
is
armed the user will have a
YES/NO option on the screen to ignore the switches before the system can trigger. When the
'YES' button is selected, a small yellow button will appear
in
the top right hand corner of the
system status panel to indicate 'ignore' option
is
active. It is important that those
in
the vicinity
of
the system are made aware that the system
is
in
this mode of operation, to ensure that
inadvertent triggering does not occur.
© The
Magst1m
company
Limited IVIOP11-l::N-01
SECTION 4
Magstim Alpha Coil Range
Operating Manual
OPERATING INSTRUCTIONS
Note: For more detailed operating instructions see the Operating Manual for the appropriate
stimulator.
Note: to avoid problems with interference, the stimulating coils 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
At the start
of
each session the operator must check the external casing surrounding the coil for any
signs
of
damage. If any cracks are visible
in
the cover or resin coating, or there is damage to
_the
handle
or
cable, the item must not be used and should be returned to The MagstIm Company Limited
for servicing and repair.
Note: The contacts
in
the coil connector, and the stimulator coil socket should be checked before
connecting to the system for any signs
of
tarnishing
or
burning. See Section 5.2 for an example
of
contact burning.
4.2 Connection
1.
Place the coil into the coil holder situated on the right hand side
of
the stimulator as shown
in
Figure 4.1. (Coil holder is situated on the right hand side
of
the master unit on the Bistim2)
~,
-
Figure 4.1: Correct method of placing coil
in
holder.
2. Connect the coil to the stimulator (Bistim2 connecting module when using the Magstim Bistim2)
by
aligning the locating key on the coil connector with the corresponding
receptor_
on
_the
coil output
socket.
It
is then possible to rotate the outer collar
of
the coil connector clockwise
in
order to lock
the coil to the stimulator.
Coil locating key Coil output
socket receptor
Figure 4.2: Locating key
on
the coil connector (left} and the stimulator coil socket (right)
© The Magstim Company Limited 6 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
3.
Care must
be
taken to attach the coil connector to the stimulator correctly (see Figure 4.3).
Note: Failure to do so can cause damage to the connector pins and
in
severe cases, internal
damage to the coil and the stimulator.
Figure 4.3: Diagram showing correct and incorrect ways to connect the coil to the stimulator
4.
Following an initialisation sequence, the stimulator will recognise the coil and the system will be
ready for use.
5.
Section 4.2 should be repeated in reverse to disconnect the coil.
4.3 Operation
4.3.1 Use with M2002, Bistim2, Rapid2 and Rapid2 Plus
1
1.
Select the desired stimulator output power/ protocol using the stimulator
UI.
2.
Use the stimulator
UI
to arm the system.
3.
Remove the coil from the coil holder of the right hand side
of
the stimulator and position the coil
over the desired target; Peak stimulation points
of
the coil can been seen
in
figures
in
Section
6.
4. Engage
an
interlock button
in
conjunction with either a footswitch or the stimulator
UI
trigger
button to trigger the stimulator and deliver the stimulus.
A clicking noise should be heard from both the coil and the stimulator.
5.
When necessary, reposition the coil and/or modify the output power/ protocol to suit requirements
for the next stimulus.
6.
At the end
of
the session, use the stimulator
UI
to disarm the stimulator and place the coil back
into the coil holder
on
the stimulator.
© The Magstim Company Limited 7 MOP11-EN-01
SECTION 5
Magstim Alpha Coil Range
Operating Manual
MAINTENANCE
5.1
User Maintenance and Calibration
There are no user maintenance or calibration requirements for the coil. However, it is important that it
is checked for any sign
of
damage at the start
of
each session. If any cracks are visible
in
the plastic
covers or resin coating, or if there is damage to the handle or cable, the coil 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 and the stimulator coil socket should be checked before connecting
to the system 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
5.3 Cleaning and Disinfecting
The coil cannot be sterilised; therefore, do not allow it to become contaminated with bodily fluids. The
coil may be cleaned using a cloth moistened with isopropyl alcohol but ensure that the coil has dried
thoroughly before use.
Note: The Magstim Company Ltd recommends that a solution of 70% isopropyl alcohol should be
used.
© The Magstim Company Limited 8 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
5.4 Servicing
Servicing
of
the coil must only
be
carried out by The Magstim Company Limited
or
persons authorised
by the Magstim Company Limited. To arrange a return or for further information, contact The Magstim
Company Limited service department (see Section 7.2 for contact details).
5.5 Device Lifetime
5.6
·,t~:t
/:~_
--
The lifetime
of
the coil is defined as being five years from the date of shipment. The Magstim
Company Limited will support the product for the duration
of
its lifetime.
Disposal
When coils from the Alpha Range reach the end of their serviceable life, they should not be disposed
of
in
general waste. The Magstim Company Limited should be contacted (see Section 7.2 for contact
details) for advice on their disposal
in
compliance with the appropriate environmental regulations.
Failure to do so could cause an environmental hazard as a result
of
decomposition
of
materials used
in
its construction.
© The Magstim Company Limited 9 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
SECTION 6 SPECIFICATIONS
6.1
Safety Specifications
During use and when used with the stimulators specified in 6.2, the type of protection against electric
shock provided by the magnetic stimulator fitted with the
070°
Coil and D70° (Coated) Coil are
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 surfaces
of
the coil are electrically isolated from the other parts
of
the equipment and meet Type BF leakage current limits as required
by
IEC 60601-1.
The Magstim
070°
Coil and
070°
(Coated) Coil comply with the requirements
of
Safety Standard IEC
60601-1 and with EMC Standard EN 60601-1-2.
To avoid problems with EMC interference, the D70° Coil and
070°
(Coated) Coil 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.
The Magstim
070°
Coil and D70a (Coated) Coil are classified as
IPXO
(Not Protected),
as
there are no
specialised protection provided against the ingress
of
liquids.
The Magstim D70° Coil and D70° (Coated) Coil 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 070a Coil and
070°
(Coated) Coil are classified as continuous.
6.2 Technical Specifications
6.2.1
D70°
Stimulator compatibility: Magstim 2002, Magstim BiStim2, Rapid2, Rapid2 Plus
1
6.2.1.1 Specification Summary
D70° P/N 4150-00
16µH
2x
090MM
10
10.5mm2
1.8-
2M
1.76kg
Magstim 2002 >= 1.55T
Magstim Rapid2 >= 0.92T
Magstim 2002 >200
Magstim Rapid2 >250
Table 6.1: D70a Coil specifications
• Starting at
an
ambient temperature of
20'C.
Magstim 2002 @75% output at 0.33Hz. Rapid2 @75% output at 1Hz.
© The Magstim Company Limited 10 MOP11-EN-01
magstim Magstim Alpha Coil
Operating Ma Range
nual
6.2.1.2
Electric
Field
Plot
d. D70AlphaApproximate E-Fiel .
6.2.1.3
Magnetic
Field
Plot
D70 Alpha
I:,
lo.B
2:::::',.,
•.
r.,
•..•••..•.••••
~.~,
.··
:;:::.,
...
,
...•
1¥>.·
·.·.·.-:-:-:
..
:··
....
::
...
:-:-:.·>:-:-·:-'
.~
--
·'/
;:
1•::
,,,
_,,.
0 -
-5
-5
01
. X [cm]
Figure
6
2·
. .
Approximate
Ma .
gnet,c
Field p .
rof1le
measured
using
a M
agstim
Rapid2
0.2
5
0
y[cm]
©Th
e Magstim Company Limited
11
MOP11-EN-01
6.2.2 D70a (Coated)
Magstim Alpha Coil Range
Operating Manual
Stimulator compatibility: Magstim 2002, Magstim BiStim2, Rapid2, Rapid2 Plus1
6.2.2.1 Specification Summary
D70° (Coated) P/N 4170-00
10.5mm2
1.8 -2m
1.75kg
Magstim 2002
>=
1.55T
Magstim Rapid2
>=
0.92T
Magstim 2002 >200
Magstim Rapid2 >250
Table 6.2: Coil specifications
* Starting at an ambient temperature
of
20°C. Magstim 2002 @75% output at 0.33Hz. Rapid2 @75% output at 1Hz.
6.2.2.2 Electric Field Plot
Approximate E-Field: 070 Alpha (coated}
Q 2
Oi!)iance from Coil Center(cm]
Figure 6.3: Approximate Electric Field Profile measured using a Magstim Rapid'
© The Magstim Company Limited
12
MOP11-EN-01
6.2.2.3
Magstim Alpha Coil Range
Operating Manual
Magnetic Field Plot
D70 Alpha (coated)
u~
1
'I
!='0.8-j
,__ :
"' i
iii
06~
.•
_
~
0.4-l
/<
:
~
~
o:1~
5
-5
y [cm]
-5
:.:.:.:
<f6
J"
x [cm]
Figure 6.4: Approximate Magnetic Field Profile measured using a Magstim Rapid2
6.3 Environmental Conditions
%
Transport and storage temperature: -19°C to 60°C
Operating temperature: 5°C to 40°C
@ Transport and storage relative humidity: 10% to 80% (non-condensing)
.
.l
I'
B Atmospheric pressure: 50kPa
to
106kPa
Note: Following transportation and
if
storage temperature is outside the operating temperature range, allow
the unit to acclimatise for 2 hours prior to use.
6.4 Packing Instructions
If,
for any reason, it is necessary to return the coil. care should be taken to ensure that
it
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 Company Limited 13 MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
SECTION 7 CONTACT DETAILS
7.1
Product Enquiries
The Magstim Company Limited
Spring Gardens, Whitland, Carmarthenshire, SA34
OHR
Telephone:
Fax:
E-mail:
Website:
+44 (0)1994 240798
+44 (0)1994 240061
rnagstim.info((b,rnagstirn.com
v,;ww.maqstim.com
7.2 Servicing Enquiries
Telephone:
Fax:
E-mail:
+44 (0)1994 242900
+44 (0)1994 240061
7.3 Sales Enquiries
Telephone:
Fax:
E-mail:
+44 (0)1994 241111
+44 (0)1994 242917
sales,Wmagstim.com
© The Magstim Company Limited
14
MOP11-EN-01
Magstim Alpha Coil Range
Operating Manual
APPENDIX A - ERROR CODES
A1. Coil Error Codes
1.t1t1s11
liiii,e~!en
I
C01
ROM checksum incorrect
CO2
EEPROM checksum incorrect
C03 Invalid coil category
C04 Invalid power identification
C05 Temperature sensor circuit failure
C06
Bad
serial command or received data checksum
C07 Internal software error
COB
Invalid coil temperature
ID
C09 Invalid temperature algorithm coefficient
C10 Coil controller malfunction
C11
Rapid Coil Algorithm Constant Checksum Incorrect
C12 Invalid Enhanced Power Byte
C13 Average Power Checksum Incorrect
C21
Coil disconnected/coil undertemperature
C22 Brown out detected
C23 No serial communications
C24
Bad
serial command
of
received data checksum (outside TRIGGATE)
C27 Hardware stop activated
C28 Watchdog timeout
C29 Temperature interlock 3 activation
C30 Coil stop line fault
For diagnosis, contact The Magstim Company Limited service department (see Section 7.2 for
contact details).
© The Magstim Company Limited
15
MOP11-EN-01
Table of contents
Other MAGSTIM Medical Equipment manuals
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MAGSTIM
MAGSTIM 200 2 User manual
MAGSTIM
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