Soterix Medical MEGA-TMS User manual

MEGA-TMS
Operator’s Manual
Version
1.0.5
US-edition ТМ063.04.001.00
(20.03.2020)

Soterix Medical © 2021
1480 US 9 North, 204, Woodbridge, NJ,
07095, USA Phone: [phone]
E-mail: [e-mail] Internet: www.soterixmedical.com

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Contents
Introduction..................................................................................................................4
Indications for Use......................................................................................................5
Contraindications........................................................................................................5
Possible Side Effects ..................................................................................................5
Warning and Precautions ...........................................................................................6
1. Description ...........................................................................................................9
1.1. Main Specifications.........................................................................................9
Delivery Set..........................................................................................................12
1.2. Structure and Operation................................................................................14
1.3. Controls, Connectors and Indicators.............................................................16
1.3.1. Controls, Connectors and Indicators of Stimulator...............................16
1.3.2. Controls, Connectors and Indicators of Coil.........................................19
1.4. Stimulator Menu............................................................................................20
1.4.1. Single Pulse Mode................................................................................20
1.4.2. Setup Mode..........................................................................................22
1.5. Labeling.........................................................................................................23
2. Assembly and Installation.................................................................................25
2.1. Requirements to Personnel Conducting Stimulator Assembly and
Installation.....................................................................................................25
2.2. Room Selection and Placement....................................................................26
2.3. Unpacking and Delivery Set Check...............................................................28
2.4. Assembly and Connection of Stimulator.......................................................29
2.4.1. General Requirements for Assembly....................................................29
2.4.2. Assembling the System........................................................................29
2.4.3. Assembling Configuration for Single Pulse Stimulation........................34
3. Proper Use..........................................................................................................35
3.1. Operation Order............................................................................................35
3.2. Stand-alone Mode.........................................................................................35
3.3. USB Control Mode........................................................................................37
3.4. Acquisition of Evoked Potentials...................................................................38
3.5. Troubleshooting ............................................................................................39
3.6. Cleaning and Disinfection .............................................................................40
3.7. Actions in Emergency ...................................................................................41
4. Servicing.............................................................................................................41
4.1. General Requirements..................................................................................41
4.2. Maintenance Service.....................................................................................41
4.3. Life Time .......................................................................................................41
5. Disposal..............................................................................................................42
6. Acceptance, Delivery Set and Package Data...................................................42
7. Warranty..............................................................................................................43
8. Reclamation Data...............................................................................................44
Annex 1. Electromagnetic Emissions and Immunity.............................................45
References.................................................................................................................49
Annex 2. Cybersecurity Guidelines…………………………………………………….50

4
Introduction
Introduction
This technical manual (hereinafter referred to as “manual”) is the combined document
describing operation and servicing of MEGA-TMS magnetic stimulator (hereinafter re-
ferred to as “stimulator”).
This manual is the document which certifies the stimulator specifications guaranteed
by the manufacturer.
Do not start working with stimulator before you have read this document!

5
Indications for Use
Indications for Use
Stimulation of peripheral nerves for diagnostic purposes.
Contraindications
Although the magnetic stimulation in single pulse mode is a safe
procedure, before the stimulation, each patient must be screened
for contraindications.
The absolute contraindications include implanted devices that are
activated or controlled in any way by physiological signals
(examples: cardiac demand pacemakers, implanted electronic
devices, cochlear implants, pregnant women).
All the rest contraindications are relative ones. In each individual case the benefit of
the test should be weighed against possible adverse effects. This judgement is best
left to a skilled clinician familiar with the characteristics of the device.
Do not use the peripheral magnetic stimulation in the following patient groups or
clinical conditions:
Patients who have conductive, ferromagnetic or other magnetic-sensitive metals
implanted in their head or within 30 cm of the coil (examples: magnetically activat-
ed dental implants, ferromagnetic ocular implants, pellets, bullets and its frag-
ments, facial tattoos with metallic ink, metal cuts, aneurysm clips or coils, carotid
or cerebral stents, implanted chips, implants with radioactive drugs, etc.)
Possible Side Effects
1. Muscle twitches.
2. Pain at stimulation side.
3. Local allergic reactions to adhesive and working surfaces of EMG electrodes.
4. Syncope.
Compared to seizure, syncope is more likely to occur during a TMS study, but this is
a rare event too. Vasodepressor (neurocardiogenic) syncope is a common reaction to
anxiety and physical discomfort and it can take place following TMS, as with many
other noninvasive or minimally invasive medical procedures. The loss of
consciousness lasts for a few seconds. The patient may faint or “pass out” and may

MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
complain to shortness of breath, anxiety, sweating, dizziness, nausea, pallor, weak
pulse, bradycardia, narrowing and blacking out of the visual field.
It should be noted that patients who develop syncope under TMS often have
experienced similar episodes in the past.
5. Dermatalgia at stimulation site.
6. Transient hearing impairment at single pulse stimulation can occur only theoretical-
ly. However, both patient and operators should always wear earplugs.
Warning and Precautions
Do not start working with the stimulator before you have read this
document!
The stimulator must be used by qualified medical personnel
trained to operate on it and are knowledgeable about magnetic
stimulation application.
While working with the stimulator it is required to observe the working
regulations concerning the safety rules while operating electrical
equipment.
High voltages (2800 V) are presented within the stimulator.
To provide safety measures and exclude the hazard of
medical staff’s or patient’s electric shock, the medical staff
is PROHIBITED:
• to use the stimulator which was mounted and installed
incorrectly, without following this manual’s instruction;
• to eliminate faults connected with opening of the compo-
nents included in the delivery set;
• to work with the stimulator when the electronic unit box,
computer or other devices used together with the stimulator
are open.
Always check the stimulator and coils for the absence of
cracks and other defects.
It is prohibited to connect the stimulator to the mains outlet that is
not grounded properly.
6

Warning and Precautions
Before the stimulation, make sure, that there are no patient cables
or electrodes connected to a patient and also metal parts contacting
with a patient in impact area (within 5 cm and less from the coil) as
far as the electromagnetic field can create the electrical current
leaking through a patient.
Do not allow the coil to come into close proximity (less than 1 meter)
with electronic equipment (monitor, computer, etc.) and magnetic
carriers (credit cards, etc.). The magnetic field emitted by the coil
can result in its damage and information loss.
It is prohibited to immerse the coil in water, ice or refrigerate to
cool it off.
The pulse evoked by the stimulator generates a loud click that can
frighten a patient. Tell a patient about the stimulation beginning or
give her/him ear plugs.
The stimulator must not be used together with the anesthetic gases
as it may ignite / catch fire
The operator must be protected from the continuous impact of
the magnetic field. It is recommended to use the holder to fixate
the coil.
If a coil heats over 41°C, the stimulator stops functioning and
indicates overheating. As coil surface temperature still increases
even after stimulation stop (owing to the thermal lag), it is essential
to move the coil immediately from the patient’s scalp to avoid
potential burn and discomfort.
To protect a patient from excessive impact by the electromagnetic
field, generate the minimal required number of pulses.
7

MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
The use of accessories, spare parts and cables other than in
delivery set may result in decreased EMC immunity and increased
emissions of the equipment.
The user must not install third-party software
The general principles of safety regulations are stated in:
• “Safety of different inter-train intervals for repetitive transcranial magnetic stimula-
tion and recommendations for safe ranges of stimulation parameters”by: Robert
Chen, Christian Gerloff, Joseph Classen, Eric M. Wassermann, Mark Hallet, Leo-
nardo G. Cohen (accepted for publication: 23 May 1997).
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1. Description
1.1. Main Specifications
Table 1. Main specifications of magnetic stimulator
Parameters Values
Stimulation Parameters
Peak magnetic field at 100% output (depends on coil):
• monophasic (FEC-03-0100)
• monophasic (AFEC-03-0100)
0 –1.5 T
0 –1.8 T
Duration of raise part of pulse:
• monophasic
80±15 µs
Maximum frequency depending on pulse intensity:
• 100% ‒0.3 Hz
• 75% ‒0.5 Hz
• 50% ‒1 Hz
• 30% ‒1.4 Hz
Power Supply
Supply voltage
110 V ~ 50/60 Hz
220/230 V ~ 50/60 Hz
Maximum power consumption during the stimulation:
• average
• peak
not more than 1250 V·A
not more than 2000 V·A
Supply-line fuses when powered from
• 220/230 V mains socket
• 110 V mains socket
5 А–2 pcs.
10 А–2 pcs.
Trig-in/out
Trig-in
TTL/CMOS
Trig-out
TTL/CMOS
Trig-in pulse width
≥ 100 µs
Stimulus delay relative to trig-in signal
≤10 µs
Trig-out pulse width (user-defined)
see Table 2
General Parameters and Specifications
Auto discharge time
3 min
Interface
USB
Safety class
I
Applied parts
BF type
Degree of protection provided by enclosures of
• electronic unit
• footswitch
IP20
IPX1
Unit dimensions
530×500×180 mm
Table 2. Continued
Parameters Values
9

MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
Unit weight not more than 30 kg
Operating Conditions
Temperature
+ (10–35)°С
Relative humidity
from 30 to 85%
(non-condensing)
Atmospheric pressure
from 70 to 106 kPa
Transportation Conditions
Temperature -25 to +60°C
Humidity from 20 to 95%
non-condensing
Atmospheric pressure from 70 kPa
Storage Conditions
Temperature +5 to +40°C
Humidity from 30 to 85%
non-condensing
Atmospheric pressure 70-106 kPa
Table 2. Range of Controlled Parameters and Frequency Step
Parameter Range of Permissible
Values
Stimulation Parameters
Frequency Step
Stimulus intensity 0–100 % 1%
Trig-out
Trig-out pulse width 100 µs–10 ms 100 µs
Table 3. Stimulation Modes
Stimulation Type
For Configuration 1
For Configuration 2
Monophasic
+
+
The specifications of coils are provided in the corresponding technical manual.
Safety and Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is ensured by conformance to international
standard IEC 60601-1-2 requirements.
The magnetic stimulator is intended for operation in electromagnetic environment, as
specified in Appendix 1.
The mobile radio-frequency devices may impact the system.
The use of accessories not listed in Table 5 and Table 6 of this technical manual can
cause the increase of electromagnetic emissions or decrease of the electromagnetic
immunity.
10

As for safety, magnetic stimulator complies with AAMI/ANSI ES 60601-
1:2005/(R)2012 requirements, it is referred to class I and has BF type work parts
complying with AAMI/ANSI ES 60601-1:2005/(R)2012 requirements.
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MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
Delivery Set
The delivery set includes the electronic unit (monophasic) with the set of coils and ca-
bles. The delivery set of the stimulator corresponds to Table 4 and Table 5.
The figures in “Quantity, pcs.” column of Table 4 and Table 5 indicate:
1 —MEGA-TMS magnetic stimulator (configuration for single pulse stimulation (here-
inafter referred to as “configuration 1”).
The complete delivery set of the stimulator is shown in Fig. 1.
Fig. 1. The external view of assembled magnetic stimulator.
1. coil;
2. flexible arm for coil positioning K-3 or K-7;
3. Trolley T-4/A with castors for magnetic stimulator (4 shelves);
4. MEGA-TMS main stimulator unit;
5. footswitch.
Table 4. Base Delivery Set
Name Order code or main
specifications
Quant., pcs.
1 2
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MEGA-TMS main stimulator unit
NS063201.001-02
1
2
End cap
NS063105.001
1
2
Footswitch
NS063353.001
1
1
Coils:
Figure-of-eight coil 100 mm FEC-03-100
NS063304.008
1
2
Big ring coil 125 mm RC-03-125
NS063304.002
1
1
Cables:
High-voltage cable for extra unit conneciton
NS063103.007
–
1
Equipotential cable
NS058103.032-050
–
1
СЕЕ7/7 –IEC C13 mains supply cable
220 V, 10 A, 1.8 m
(3G×0.75 sq. mm)
1
2
USB cable (A→B)
NS007103.005
1
1
Trolleys:
Trolley T-4/A
NS059998.009
–
1
Holders:
K-8 coil holder (trolley/wall mounted)
NS059998.004
–
1
Operating Documentation:
MEGA-TMS technical manual
TM063.01.001.001
1
1
Coils for magnetic stimulators “MEGA-TMS”and
“MEGA-TMS”technical manual
TM058.02.003.000
1
1
Package:
Cardboard package (set)
–
1
1
MEGA-TMS unit package
NS063901.001
1
2
Table 5. Additional Equipment, Accessories and Software Included in Delivery Set by Customer’s Request
Name
Order code or main
specifications
Quant., pcs.
1
2
Coils:
Angulated figure-of-eight coil 100 mm AFEC-03-100
NS063304.011
1
1
Cables:
Trig-in cable for synchronization via electrical
stimulator: DIN8 ß DIN5 (240°)
NS063103.010
1
1
Trigger cable: BNC ‒BNC
NS063103.009
1
1
Holders:
K-3 flexible arm for coil positioning
NS016998.012
1
1
K-7 flexible arm for coil positioning
NS016998.018
1
1
K-8 coil holder (trolley/wall mounted)
NS059998.004
1
−
Trolleys:
Trolley T-4/A NS059998.009 1 –
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MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
1.2. Structure and Operation
Depending on the selected configuration, MEGA-TMS magnetic stimulator can include
one stimulator unit (hereinafter referred to as “stimulator”). Stimulator unit allows to
generate single electromagnetic pulses of specified intensity.
The block diagram of system with 1 stimulator unit intended for single stimulation is
shown in Fig. 2.
The block diagram of the magnetic stimulator unit (Fig. 2) consists of control circuitry,
capacitor, capacitor charging circuitry intended for the capacitor charge up to achiev-
ing the voltage specified by the control circuitry and the high-voltage electronic switch
(Fig. 2).
z
Fig. 2. The block diagram of stimulator.
The principle of operation of magnetic stimulator is based on discharge of high voltage
capacitor (max 2.8 kV) through copper winding at the moment the electronic switch is
being closed. At this time the discharge current (up to 12 kA) generates the electro-
magnetic field. This field induces the current in nearby body tissues which causes
nerve pulse as during usual electrical stimulation.
The magnetic stimulator generates the following pulse waveform:
• Monophasic pulse –is a pulse when current in the coil flows in one direction in-
creasing sinusoidally and decreasing exponentially (Fig. 3Fig. 3).
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Fig. 3. Monophasic waveform.
The current flowing through the coil results in heating. The higher is the pulse intensity
and stimulation frequency, the quicker is the heating of the operating surface of the
coil. The contact with this heated surface can evoke hyperaemia or burn. To control
the temperature, the coils are equipped with the temperature sensors. The indications
of these sensors are controlled by the stimulator control system. In case the coil heats
up to 41º C, the stimulation is stopped, and the stimulator notifies a user about it.
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MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
1.3. Controls, Connectors and
Indi ca to rs
1.3.1. Controls, Connectors and Indicators
of Stimulator
Fig. 4. The front panel of stimulator.
The front panel of stimulator contains:
1. “Coil change”button combined with “High voltage”indicator.
The “High voltage” indicator highlights yellow when the stimulator is
switched on and up to 2800 V high voltage is supplied inside the
stimulator. While the high voltage is supplied to coil connector at the
moment of pulse delivery, it is dangerous to disconnect the coil. To
replace the coil, press “Coil change” button which switches off the
internal high-voltage power supply and discharges instantly the high-
voltage capacitor to the safe voltage. After that the “High voltage”
indicator stops illuminating. After the coil replacement press “Arm” button
to resume the capacitor charge up to specified value.
2. “Coil connector”high-voltage connector to plug in the coil.
3. Multifunctional LCD display intended to show information on current mode and
other parameters. The detailed description is given in 1.4 “Stimulator Menu”
section.
4. “Arm” button.
If stimulator is in disarmed state, press “Arm” button to initiate capacitor
charge. The “Charging” symbol first appears on display. On charge
process completion, the stimulator then enters the “Arm” state and is
ready to deliver pulses. At that time, “Armed” symbol appears on display.
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5. “Trigger” button.
When stimulator is in “Armed” state, the single pressing of “Trigger”
button activates the single stimulation. To perform continuous
stimulation, press and hold “Trigger”button. The pulse is generated
continuously when stimulator reaches “Armed” state. To stop
the stimulation, release “Trigger”button. This button is duplicated with
“Trigger” button located on the coil handle and with footswitch pedal.
When pulse safety interlock function is enabled, press any two controls
simultaneously (“Trigger” button, “Trigger” button on coil handle and
footswitch pedal).
6. “Stimulation parameters”knob.
The “Stimulation parameters” knob allows to increase/decrease
the current value of selected parameter by turning the knob clock-
wise/anticlockwise respectively.
7. “On/Off” button.
“On/Off” button toggles the operational mode of the stimulator. When mains
power is delivered, the stimulator enters the standby mode. This is indicated
by the yellow light of the “Power” indicator. Push the “On/Off” button in the
standby mode to set the stimulator into the operational mode. This is indicated
by green light of the “Power” indicator. At that time, the stimulator switches to
“Disarmed” mode. On operation completion, the stimulator can be switched to
standby mode by pushing “On/Off” button.
Fig. 5. The rear panel of stimulator.
The rear panel contains:
8. Connector to plug in mains supply cable.
9. “Mains power” switch.
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MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
To deliver the mains supply to the magnetic stimulator, turn “Mains power”
switch to On (I) position. To disconnect from the mains supply, set the “Mains
power”switch to Off (0) position.
10. USB connector.
The connector is intended to attach the stimulator to the computer using
USB cable.
11. Footswitch connector.
The connector is used to plug in the footswitch intended to control
the stimulation. See details in 1.4.2 “Setup Mode” section.
12. Labeling.
13. Plug in and fix the end cap (NS063105.001) on this connector using two screws.
If this connector is not plugged, the corresponding error will appear at display
(see 3.5 “Troubleshooting” section).
14. Cooling fans output. The fans provide the air circulation inside the stimulator unit.
The air is sucked through the holes located on the bottom panel and blown out
via the cooling fan outlet, at the rear panel.
15. Fuses.
The mount of fuses.
16. Mains voltage selector.
17. Equipotential clamp . The clamp to attach the equipotential cable connecting
the cases of units included in the system.
18. Ground clamp .
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Fig. 6. Coil.
The coil contains:
1.3.2. Controls, Connectors and Indicators
of Coil
1. HV connector into plug into stimulator unit.
2. “Trigger” button combined with “Armed/Overheating” indicator.
The indicator illuminates with:
‒“red” –the coil is overheated; the stimulation is impossible;
‒“green” –the stimulator is ready to deliver pulses.
Press the button to evoke a pulse. If pulse safety interlock option is enabled, press
“Trigger” button at the unit or footswitch pedal. If the coil is equipped with buttons on
both sides, press “Trigger” button at the second side of this coil.
If the stimulator is in disarmed state, press and hold “Trigger” button and press “+”
button to start capacitor charge. It is the same as to press “Arm” button on the front
panel of the stimulator.
3. “‒” button. Press this button to decrease the pulse intensity.
4. “+” button. Press this button to increase the pulse intensity.
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MEGA-MS/Neuro-MS Magnetic Stimulator (Technical Manual)
1.4. Stimulator Menu
1.4.1. Single Pulse Mode
2 3 4
1 5
8 7 6
Fig. 7. The single pulse mode.
The stimulator display in single pulse mode shows the following (Fig. 7):
1. “Coil temperature” indicator.
The “Coil temperature” indicator is a scale showing coil heating:
• white color indicator –the coil temperature is below 10
0
C;
• indicator is filled but not completely –the coil temperature is from 10
to 400C;
• the indicator is filled completely, red segment illuminates –the coil
temperature is more than 410С. At that temperature, pulse delivery is
disabled.
2. Current coil temperature in Celsius degrees.
3. Indicator of “Intensity” parameter.
Blue frame around an icon informs a user that this parameter is active and
can be adjusted with the “Stimulation parameters”knob.
4. “USB control” indicator
If this icon is displayed, it means that the stimulator is connected to
computer via USB and is controlled with the related software.
5. “Intensity” indicator. It shows pulse intensity in percentage from maximum one
(1). The default value at stimulator switch on is 30%.
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