Deymed DuoMAG MP Series Parts list manual

Without the prior written consent of Deymed Diagnostic s.r.o. no part of this document may be copied or
reproduced in any form or by any means.
© 2019, DEYMED Diagnostic s.r.o. All rights reserved
Technical description and
instructions for use
DuoMAG TMS technical description and instructions for use
Revision: DM004-IFU1902EN
Date of issue: 14. 02. 2019

DuoMAG TMS technical description and instructions for use
DEYMED Diagnostic s.r.o. 2 Version: DM004-IFU1902EN
Content
1. Identification of the Product.................................................................................. 4
Manufacturer................................................................................................................ 4
Product type designation.............................................................................................. 4
Intended Use................................................................................................................ 4
Classification of DuoMAG Magnetic Stimulator............................................................ 5
Classification of the Stimulation Coils .......................................................................... 5
Production labels ......................................................................................................... 6
Labeling of the DuoMAG Magnetic Stimulator .....................................................................6
Labeling of the magnetic stimulator DuoMAG......................................................................7
Labeling of the Stimulation Coil............................................................................................8
A description of used signs.......................................................................................... 9
Description of light indicators..................................................................................... 10
2. Cautions and Warnings ....................................................................................... 10
3. Indications and Contraindications...................................................................... 15
Indications.................................................................................................................. 15
Diagnostic application........................................................................................................15
Therapeutic application......................................................................................................15
Contraindications ....................................................................................................... 15
4. Installation and commissioning.......................................................................... 16
Operation, Storage and Transportation conditions..................................................... 16
Recommended room equipment................................................................................ 16
Device installation...................................................................................................... 17
Device commissioning ............................................................................................... 17
Electromagnetic Compatibility.................................................................................... 17
Class and group of emission..............................................................................................17
Environment description ....................................................................................................17
Functionality of the device when used with other devices..................................................17
List of all cables and maximum lengths and other accessories..........................................18
RF transmitter contained in the control PC ........................................................................18
Compliance for each emission and immunity standard ......................................................19
5. Description of the Device .................................................................................... 23
Front Panel ................................................................................................................ 23
The Rear Panel.......................................................................................................... 24
Assembly of the Magnetic Stimulator......................................................................... 26
Stimulation Coils ........................................................................................................ 26
Configuration and assembly....................................................................................... 30

DuoMAG TMS technical description and instructions for use
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DuoMAG , type XT..................................................................................................... 30
DuoMAG , type MP.................................................................................................... 32
Use in Conjunction with EMG / EP, EEG device or neuronavigation ......................... 34
6. Operating the system........................................................................................... 36
Operating the Magnetic Stimulator............................................................................. 36
Description of the Device Controls............................................................................. 36
Turning on and operating the Magnetic Stimulator.............................................................36
Setting the stimulation intensity and start stimulation.........................................................37
Changing the Stimulation Coil............................................................................................38
Turning off the Magnetic Stimulator...................................................................................38
Operating the system with the control PC (XT models only)...................................... 39
Starting the system............................................................................................................39
Turning off the system.......................................................................................................40
Patient screen....................................................................................................................40
Add / Edit Patient...............................................................................................................44
Protocol Setup Screen.......................................................................................................46
Repetitive Protocol Setup ..................................................................................................49
Burst Protocol Setup (for DuoMAG XT-100 only)...............................................................52
Display Setup Screen........................................................................................................55
MEP/MT Single Pulse Screen............................................................................................58
Therapy / Protocol Screen.................................................................................................63
System Configuration Screen ............................................................................................67
Advanced System Configuration Screen............................................................................70
Config Codes Manager......................................................................................................73
7. Conventional procedures for using the device ................................................. 75
Spatial configuration................................................................................................... 75
Single pulse stimulation ............................................................................................. 75
Protocol Stimulation................................................................................................... 76
8. Maintenance, Cleaning and Disinfection............................................................ 77
9. Troubleshooting................................................................................................... 77
Replacing fuses ......................................................................................................... 78
Changing the power cable ......................................................................................... 78
10. Specifications.................................................................................................... 79
11. Disposal of the product.................................................................................... 82
12. Consumables .................................................................................................... 84
13. Clinical Recommendations and Literature ..................................................... 86

DuoMAG TMS technical description and instructions for use
DEYMED Diagnostic s.r.o. 4 Version: DM004-IFU1902EN
1. Identification of the Product
Manufacturer
DEYMED Diagnostic s.r.o
Kudrnacova 533
Hronov 549 31
Czech Republic
Tel.: [phone]
e-mail: [email protected]
Web: www.deymed.com
IČO: 25284584
DIČ: CZ25284584
Product type designation
DuoMAG comes in two types.
DuoMAG, type MP
DuoMAG, type XT
•model XT-10
•model XT-35
•model XT-100
Intended Use
Magnetic stimulator DuoMAG is intended to stimulate peripheral nerves and central
nervous system by induced electrical current for diagnostic and treatment purposes.
It is manufactured in two versions, type MP - monophasic and type XT - biphasic, varying
the shape of the stimulation pulse.
The Magnetic Stimulator type MP - Monophasic version is designed for low frequency
stimulation of cortical, spinal and peripheral nerves.
The Magnetic Stimulator type XT - Biphasic variant is designed for both low and high
frequency stimulation of cortical, spinal and peripheral nerves.

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The magnetic stimulator is typically used for testing MEP (motor evoked potentials) may
also substitute electrical stimulation upon examination of motor or sensory nerves.
High-frequency stimulation is used mainly for research purposes. The system is intended
solely for use in a health care environment by users with professional medical
qualifications, preferably with a neurological or psychiatrical specialisation.
The Magnetic Stimulator is usually used in conjunction with an EMG/EP or EEG device.
The Magnetic Stimulator canbe also connected with a frameless neuronavigation system.
low-frequency*
diagnostic
application
low-frequency
therapeutic
application
high-frequency** mainly
therapeutic application
DuoMAG, type MP
YES
YES
NO***
DuoMAG, type XT
YES
YES
YES
*) According to technical literature, low-frequency transcranial magnetic stimulation is
considered to be frequencies lower than about 1 Hz.
**) According to technical literature, high-frequency transcranial magnetic stimulation is
considered to be frequencies higher than about 1 Hz.
***) The monophasic type Magnetic Stimulator (DuoMAG type MP) is not physically
capable of performing high-frequency repetitive stimulation.
Classification of DuoMAG Magnetic Stimulator
Classification according to Annex No. 9 Government Regulation No. 54/2015 Sb. as
amended by Implementing Rule no.10 to Class IIa, active, non-sterile.
The Magnetic Stimulator is powered from the mains and is in safety class I (classification
according to ČSN EN 60601-1).
Safety classification for Magnetic Stimulator: IP 20 (protected from touch by fingers, not
protected from liquids).
The device is designed for continuous operation in non-explosive environments without
anaesthetics.
Classification of the Stimulation Coils
Patient electrical isolation classification: BF.
Safety classification for stimulation coils: IP 20

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Stimulation Coils 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-Cool, 70BFP-Cool and
120BFV are intended solely for use with DuoMAG Magnetic Stimulators. They are
compatible with both types of magnetic stimulators, i.e. DuoMAG XT and DuoMAG MP.
A complete version of the declaration of conformity and certificate from the notified body
confirming the requirements of the above-mentioned directive are available upon request
from the Supplier.
Expected lifetime
The shelf life of the Magnetic Stimulator is set at 8 years from the date of installation. Life
expectancy is at least 20,000 operating hours.
The shelf life of the Stimulation Coils 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-
Cool, 70BFP-Cool and 120BFV is 5 years.
Production labels
Labeling of the DuoMAG Magnetic Stimulator
Patterns of magnetic stimulator DuoMAG XT and MP labels

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Labeling of the magnetic stimulator DuoMAG
Sample DuoMAG type XT System label.
Sample DuoMAG type MP System label.

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Labeling of the Stimulation Coil
The 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-Cool, 70BFP-Cool and 120BFV
Stimulation Coil labels:

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A description of used signs
Before connecting the device and its use to first carefully read the complete
documentation
Using the device is accompanied by a number of risks, take note of warnings and cautions
in this documentation, particularly in chapter 2
Warning "DANGEROUS VOLTAGE" Inside the device is a high voltage dangerous to life.
The stimulator or stimulation coil is not allowed to repair, modify or open the cover.
Applied part: BF (classification of insulation according to ČSN EN 60601-1).
The manufacturer declares conformity with applicable standards assessed by notified
person no. 2265
Manufacturer
Date of manufacture
Serial number
The device includes an RF transmitter
This product and its electronic accessories should
not be mixed with other commercial wastes for
disposal! For more information see chapter
Disposal of the product.
Other definitions
Supplier = Manufacturer or its Authorized Representative.
Control PC / Control Software = Software in an external PC, laptop or similar device which
controls the Magnetic Stimulator and displays its current state.

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Description of light indicators
Location of indicator lights is shown in chapter Description of the Device.
Meaning of colored indicators:
•Red and Green indicators on = unconnected coil, overheated coil or defective
Stimulation Coil.
•Red LED indicator only = overheated Stimulator or defective Stimulator.
•Green indicator lights only = the Stimulator is in the inactive (standby) mode or a
stimulation is currently being given.
•The Green and the Orange indicator = Stimulator is charged at the set level and
prepared for use.
2. Cautions and Warnings
To avoid risk of electric shock, the Magnetic Stimulator must be connected to a mains with
a protected ground!
The Magnetic Stimulator must NOT BE USED on patients with electronic implants such
as cardiac pacemakers, cochlear implants or other implanted electronic devices, doing so
may lead to temporary disabling its function or permanent damage of the implanted
devices.
The Magnetic Stimulator is also not allowed to be used in the immediate vicinity (approx.
30 cm) from metal spinal or joint implants! There could be an undesirable mechanical
affect on the metal part and/ or heating to a level above their safety limits.
The Magnetic Stimulator can not be operated by a person with an implanted electronic
device whose proper function can affect his life or health. Even a single stimulation pulse
at inappropriate Stimulation Coil position may lead to damage of the implanted device or
to affect its function. Implanted device is particularly intended a pacemaker and
defibrillator (including retained electrodes after deplantation), neurostimulator, infusion
device, vital signs monitor (heart rate monitor), aneurysmal vascular clips, cochlear
implants.
The Magnetic Stimulator can not be operated by a person who has metal or ferromagnetic
objects placed in or on the body. These objects if positioned in sufficient proximity to the
Stimulation Coil and sufficient intensity of the stimulation pulse may get very hot or rapidly
change their position. It is a ferromagnetic or metal bone or joint implants, intravascular
implants (stents, venous filters), metallic valve replacement, ventricular brain drainage,
metal fragments, splinters, also implanted electronic devices that are formed from metallic
or ferromagnetic materials.

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Cortical stimulation of higher intensity can cause epileptic seizures!
Stimulation of higher intensity near the heart can cause cardiac fibrillation!
The Stimulator is not allowed to be used near flammable or explosive gases or
anaesthetics!
If the surface of the Stimulation Coils are not dry, it is forbidden to stimulate!
Do not attempt to disassemble the Stimulator, even after disconnecting the mains cable.
The only user serviceable part is the replacement of fuses and the mains supply cable.
Inside the Stimulator, a fault in the discharge circuit could give off life-threatening high
voltages up to thirty minutes after shutting down and disconnecting the stimulator from the
wall socket.
During stimulation there is an intense short sound, with the shape and sound very similar
to an audio stimulation.
If it is necessary to stimulate at higher intensities near the ears, it is advisable to use
protective ear plugs.
When attempting cortical stimulation in the vicinity of the ears, it is also advisable to
remove any metal earrings. In this case, also remove any metal clips in your hair. The
same applies to glasses, which the patient should also remove before any cortical
stimulation. The main concern in this case would be the chance of the frames of the
glasses being broken due to the stimulation. If it is necessary to stimulate patients with
piercings, proceed in small steps from lower to higher stimulation intensities. Keep in mind
that the resulting stresses exerted on the metal object are not linear with the applied
intensity of stimulation, but with its square (raised to the second power). This means that
with the increasing intensity of the stimulation, the effect sharply increases. The distance,
orientation (with asymmetrical spot objects) and the position of the Stimulation Coil can
have a major influence on the mechanical and thermal effects. Mechanical and thermal
effects are otherwise directly related to each other. When stimulating peripheral nerves,
the patient should take off watches, metal rings or any other metal jewellery.
Testing pregnant women is currently not recommended as there is not yet enough
information to eliminate the safety risks of magnetic stimulation!
Increased intracranial pressure is a contraindication for repetitive magnetic stimulation.
Another magnetic stimulation contraindication is the presence of implants (cochlear,
ocular, stents, clamps) and also for rTMS, electrically conductive ink tattoos placed near
the stimulated position. Proximity means distance up to about 20 cm from the coil centre.

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It is recommended that every hospital or lab using the TMS should provide patients with
a questionnaire prior to receiving TMS/rTMS. This questionnaire should include questions
on the presence of all conditions that could present contraindications and other potential
problems.
Note: Unlike NMR (Nuclear Magnetic Resonance) the magnetic stimulator doesn't affect
active magnetic units (Fe, Co, Ni - iron, cobalt, nickel alloys and magnets based on rare
earth metals). It affects electric conductive materials no matter their magnetic activity. This
is observable especially on loose parts approx. 2 cm diameter and bigger. It is also not
allowed to stimulate near or around large metal surfaces, which in contrast, could damage
the coils and/or destroy the stimulator.
Stimulation Coils 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-Cool, 70BFP-Cool and
120BFV are NOT intended for use inside a diagnostic NMR (nuclear magnetic resonance)
imaging device. This may not only damage the coils due to larger mechanical stress, but
also the expensive NMR equipment.
The Magnetic Stimulator, of its functional nature, must emit a relatively strong magnetic
pulse that can affect the operation or even damage other medical devices, especially
electronic. Risk of damage to electronic devices should be considered during stimulation
in the immediate vicinity (less than about 30 cm) of these devices. Stimulation in the
vicinity of about 30 cm to about 2 m from diagnostic medical devices can cause jamming
of its signal or scanned image, but it should not affect their basic function (i.e., system
failure, loss of data, interruption of communications, etc. should not occur).
Before turning on the power switch, be sure to first connect the Stimulation Coil. Before
exchanging or swapping Stimulation Coils, either for the same or a different type of Coil
(due to overheating or other reasons), first turn off the main power switch!
Before turning on the Magnetic Stimulator, check the power cord connection into the
outlet. Check the integrity of the Stimulation Coil body, Stimulation Coil cable integrity and
proper connection of the Stimulation Coil into the Magnetic Stimulator.
If when using the software interface of the Magnetic Stimulator, the intensity value
displayed in the software and the intensity value displayed on the stimulator unit do not
match, unplug the USB cable from the Control PC as you may have a defective Control
PC or software problem.
If during stimulation the Stimulation Coil emits sounds noticeably different than you are
used to, gives off any strange smell, changes its color, shape, or starts to overheat such
that when touched, it burns the skin, discontinue use of the Coil and contact your supplier.

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The surface of the Stimulation Coils can get hot during and after a longterm stimulation! It
is expected that there may be incidental or accidental contact, although the Stimulation
Coil is not intended for direct contact with the patient's skin.
During and after stimulation, the temperature on the surface of the Stimulation Coil may
increase for several minutes (up to 60 °C), which is due to its high thermal inertia.
Stimulation coil is forbidden to cool liquids or ice. Cooling of the stimulation coil is only
allowed under the following conditions: the stimulation coil must be disconnected from the
magnetic stimulator, and the cooling requirements must be met with the requirement to
maintain non-condensing air humidity on the surface of the coil during rapid transition
between environments.
For power supply, use only the supplied power cord if it is damaged, do not repair it, but
contact your supplier. It is forbidden to use extension cords!
The Magnetic Stimulator and/or Stimulation Coil are not allowed to be repaired by anyone
not directly Certified and Authorized by the Manufacturer (except for replacing fuses of
the same type). The Magnetic Stimulator can onlybe used with Stimulation Coils approved
by the manufacturer! Some types of Stimulation Coils from other manufacturers can have
a similar type of connector, but are still not made for use with this Magnetic Stimulator.
Do not block the fan vents at any time, even after use of the Stimulator. Keeping the fan
unblocked prevents excessive heat from building up in the Stimulator and prolongs its life.
Any unqualified repair or modification of the Magnetic Stimulator could lead to the patient
or operator threat or to damage or destruction of the device. Any modification of the
Magnetic Stimulator, its Coils or included cables is not allowed!
When performing cortical stimulation, it is recommended to follow the maximum intensity
and the frequency of stimulation limits, as described in Literature [1].
While the digital display and indicator lights are industrial quality parts, they could have
failures which would be manifested by one or more of them not lighting up However, it is
very unlikely, that the digital display or indicator LEDs would turn on in a situation when
they shouldn't. To minimize the risk of misinterpretation, the user should check each time
the stimulator is turned on to see that all LED indicators briefly light up (red, orange and
green), and the numeric display briefly shows the number '188'. This potential warning is
especially true if the device is operated independently without connecting to a control PC.
Please pay attention to these potentially misleading situations:
Video equipment is often equipped with the same type of connector and connects using
the same or very similar cables (BNC connectors and cables). If you accidentally connect

DuoMAG TMS technical description and instructions for use
DEYMED Diagnostic s.r.o. 14 Version: DM004-IFU1902EN
the input or output BNC connector of the Stimulator to a video device, you would most
likely not damage the video device or Stimulator. However, this is no way to guarantee. It
is possible and even likely that the connection to the video input of the BNC connector
would start a high frequency stimulation!
The RJ45 connector placed on the back of the Magnetic Stimulator is intended for use
only with Deymed EEG/EMG devices. As with the previously mentioned BNC connectors,
this connector is also designed for synchronization and starting the stimulation. If you
connect a standard network UTP cable to this connector, it should probably not lead to
the damage of the network components or the Magnetic Stimulator. However, this is no
way to guarantee. It is possible that this kind of connection would start a high frequency
stimulation, it is necessary before connecting any cables turn off the magnetic stimulator!
In the event of mechanical or electrical failure of the Stimulator, turn the Stimulator off and
contact the supplier, as the only allowable repair by the user is changing the fuses of the
same type and nominal current. However, it is appropriate to entrust the replacement of
fuses to professional staff. After replacing the fuse or fuses, do not forget to tighten their
cover. With repeated interruptions of protective fuses turn off the device by main switch,
unplug it and contact the supplier. Before replacing any fuses of the Stimulator, be sure
to disconnect it from the power mains!
To the control PC it is forbidden to connect any device that does not meet the standards
of ČSN EN 60601-1, especially external drives with its own power supply.
Ethernet cable (connected via RJ45 connector) must not be connected without the use of
a network switch or separator that meets the standards of ČSN EN 60601-1.

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3. Indications and Contraindications
Indications
Diagnostic application
Multiple sclerosis (MS),
Amyotrophic lateral sclerosis (ALS),
Cerebrovascular accident (CVA)
Parkinson's disease,
Dystonia,
Traumatic brain injury,
Spinal cord injury,
Bell's palsy,
Guillain-Barré syndrome,
Demyelinating polyneuropathy,
Epilepsy,
Corpus callosum agenesis / disgenesis.
Therapeutic application
Depression
Contraindications
Absolute:
1. electronic implants - cardiac pacemakers,
2. metal spinal or joint implants in the immediate vicinity (approx. 30 cm) to the
stimulation position,
3. increased intracranial pressure,
4. implants (cochlear, ocular, stents, clamps) and electrically conductive ink tattoos
placed near the stimulated position (approx. 20 cm)
Relative:
1. gravidity,
2. childhood - risk acceptance should be considered in connection with not fully
developed hearing.

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4. Installation and commissioning
Operation, Storage and Transportation conditions
Operation conditions:
•temperature: 5 °C to 35 °C
•relative humidity: 10-80 %, non-condensing
•atmospheric pressure: 50 kPa -107 kPa
Storage and transportation conditions:
•temperature: -25 °C to 45 °C
•relative humidity: 10-80 %, non-condensing
•atmospheric pressure: 50 kPa -107 kPa
Note: atmospheric pressure of 50 kPa corresponds to an altitude of about 5,500 m above
sea level.
Note: If the device has been moved from a long stay in a cold area to a warmer area, let
it acclimatise for at least an hour before using. This will ensure evaporation of condensed
humidity. When transporting, it should be noted that the weight inside the unit may not be
distributed evenly.
When transporting the Magnetic Stimulator in a position other than lying down, it can
damage the BNC or display panel due to its own weight, therefore, in transport, use the
supplied shipping container or transport stimulator in working position (lying down) and
keep it from shifting or moving under its own weight in the transport area. Disconnect the
Stimulation Coil during transport to avoid mechanically stressing the mount socket or
connector.
Situate the device so the power cord of the Magnetic Stimulator is accessible and it can
be simply unplugged from the mains power socket.
Recommended room equipment
The following recommendations are not neccessary, however they lead to improved
durability, performance parameters and quality of operation.
Use a separate electrical circuit wiring for the device.
Do not mechanically or thermally stress the power cable. Keep the cable leading directly
from the socket to the device and do not conflict it with other cables.

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Utilising air-conditioning capable of maintaining the temperature at 20 °C, especially for
performing longer therapeutic protocols, extends the maximum duration of the protocol
until the Stimulation Coil overheats.
An electromagnetically shielded room has an impact, particularly on the signal quality in
measurements related to the TMS method (such as EEG or EMG).
Device installation
The device is installed on site by the service technician of the supplier.
Device commissioning
When the device is installed, the service technician will test the device, introduce it to the
user and give the training course.
Electromagnetic Compatibility
Class and group of emission
Group 1 –Class A
Environment description
The device can be operated only in a professional health care environment.
NOTE: The EMISSIONS characteristics of this device make it suitable for use in industrial
areas and hospitals (class A according CISPR 11). If it is used in a residential environment
(for which is normally required class B according CISPR) this device might not offer
adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the equipment.
Functionality of the device when used with other devices
WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.

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The magnetic stimulator has been tested in a block or adjacent configuration with the
following devices:
•Elektromyograph TruTrace EMG
•Elektroencefalograph TruScan EEG
•Neuronavigation Brainsight TMS
•Control PC (only types specified or provided by the manufacturer)
•USB hub (only types specified or provided by the manufacturer)
List of all cables and maximum lengths and other accessories
The list is provided in chapter Consumables.
WARNING: Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation
WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the Magnetic stimulator DuoMAG, including cables specified by the
manufacturer. Otherwise, it may cause functionality deterioration of this device
RF transmitter contained in the control PC
The control PC may contain an RF transmitter.
All operating frequencies or frequency bands for the transmission of this RF transmitter
are given in the accompanying documentation of the control PC, which also contains
information on the declaration of conformity with the requirements of the standards.
Effect of other devices and influencing by other devices
The Magnetic Stimulator, of its functional nature, must emit a relatively strong magnetic
pulse that can affect the operation or even damage other medical devices, especially
electronic.
Risk of damage to electronic devices should be considered during stimulation in the
immediate vicinity (less than about 30 cm) of these devices. Distances mean the distance
from the nearest point of the application portion of the stimulation coil. During stimulation
at this distance from another electronic medical device, there is real risk of data loss,
disturbance or interruptions of communication, failure or the restarting of the system, etc.

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Stimulation in the vicinity of about 30 cm to about 2 m from diagnostic medical devices
can cause jamming of the signal or scanned image, but it should not affect their basic
function (i.e. system failure, loss of data, interruption of communications, etc.).
Extremely sensitive, especially electrophysiological devices (EEG, EKG, EMG, etc.) often
interfere with the so-called stimulation artifact into the input electrodes of amplifiers even
at relatively large distances (more than 2 m), more in the chapter Use in Conjunction with
EMG / EP, EEG device or neuronavigation.
Stimulation coils DuoMAG type: 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-Cool,
70BFP-Cool and 120BFV are not intended for use with the NMR device, however, the
magnetic stimulator alone may be used in rooms or near the NMR of the instrument after
its additional interference. NMR instruments are extremely sensitive to electromagnetic
radiation in the range of tens of MHz. To use the Magnetic Stimulator near an NMR device,
contact the vendor, as you may need to provide additional electromagnetic shielding of
the electric mains inputs from the Magnetic Stimulator using additional filters.
One of the few basic ways to eliminate or reduce interference to nearby devices, is to
increase the distance between the point of stimulation and these devices. When using
instruments sensitive to fluctuations in the mains voltage, it is appropriate to connect the
Magnetic Stimulator to a separate outlet circuit.
On the other hand, the magnetic stimulator is not affected by other medical devices.
Compliance for each emission and immunity standard
Emission
The DuoMAG Magnetic Stimulator meets the requirements for conduction-disturbed
emission and electromagnetic emissions for group 1, class A according to
ČSN EN 55011 ed. 4:2010+A1:2017
Conducted emisions on network clamps according to ČSN EN 55011
Frequency range MHz
Limit value dB [µV]
Quasi-peak value
Mean value
0,15 –0,50
79
66
0,5 –5
73
60
5 –30
73
60
Radiated emissions (distance 10 meters) according to ČSN EN 55011
Frequency
range MHz
Limit value dB [µV/m]
Quasi-peak value
30
40
230 - 1000
47

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Radiated emissions (distance 3 m) according to ČSN EN 55032
Frequency
range MHz
Limit value dB [µA]
Quasi-peak value
Mean value
1000 - 3000
76
56
3000 - 6000
80
60
Magnetic stimulator DuoMAG meets the requirements of ČSN EN 61000-3-2 ed. 4: 2015
to the harmonic currents injected into the public grid for class A.
Magnetic stimulator DuoMAG meets the requirements of ČSN EN 61000-3-3 ed.3:2014
for voltage changes, voltage fluctuations and flickerin low voltage grids for equipment with
a rated phase current ≤ 16 A not subject to conditional connection.
Immunity
The magnetic stimulator DuoMAG meets the immunity requirements:
Electrostatic discharge according to ČSN EN 61000-4-2 ed. 2:2009
test level of immunity:
•for contact discharge: ± 8kV
•electrostatic discharge (ESD): ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
Radiated high-frequency electromagnetic field according to
ČSN EN 61000-4-3 ed. 3: 2006 + A1: 2008 + Z1: 2010 + A2: 2011
Frequency
AM
Frequency of
modulation
Polarization
Intensity
of field
[V]
80 MHz - 2.7 GHz
80%
1 kHz
Horizontal
3
80 MHz - 2.7 GHz
80%
1 kHz
Vertical
3