510520e_05_GAW_PowerMAG_100226_en-1

OPERATING MANUAL
PowerMAG
Repetitive Magnetic Stimulator
30 Hz / 100 Hz stimulator
30 Hz / 100 Hz research stimulator
Sales and service

MAG & More GmbH
Magnetic and Life Science Systems
Geisenhausenerstr. 11a
D-81379 Munich
Tel. +49 (0)89 2018 5248
www.magandmore.com
Manufacturer
Heitec AG
Werner-von-Siemens-Strasse 61
D-91052 Erlangen
Tel. +49 (0)9131 877-0
www.heitec.de
Release: February 2010

Ord. no.: 510520e 05
Copyright 
Heitec AG
D-91052 Erlangen
Tel. +49 (0)9131 877-0

Fax +49 (0)9131 877-199
www.heitec.de
This operating manual is protected by copyright. All rights reserved.

Reproductions - even excerpts - require our express written consent!
This operating manual pertains to the medical

device(s) with the serial number(s) SN
Operating manuals without serial numbers are intended for general informational purposes.
Operating manuals with serial numbers are assigned to the medical device identified with the same
serial number and must be kept easily accessible in the vicinity of this medical device. Images and
photographs should show principal features and therefore do not always precisely reproduce the
supplied condition.
rTMS February 2010 Page 1

TABLE OF CONTENTS
TABLE OF CONTENTS
Page
1. IDENTIFICATION ................................................................................................................ 5
2. INTENDED USE .................................................................................................................. 6
3. WARNINGS AND SAFETY INSTRUCTIONS ..................................................................... 7
3.1. The basics ...................................................................................................................... 7
3.2. Contraindications of use ................................................................................................. 9
3.3. Residual risks and safety guidelines .............................................................................. 9
3.4. Safe operation of the rTMS .......................................................................................... 10
3.5. Measures for maximum patient safety ......................................................................... 12
3.6. Safety note for the trolley.............................................................................................. 12
3.7. Liability of the manufacturer ......................................................................................... 13
4. DESCRIPTION OF THE SYSTEM .................................................................................... 14
4.1. Physical operating method ........................................................................................... 14
4.2. Motor threshold ............................................................................................................ 14
4.3. Pulse shapes ................................................................................................................ 15
5. DEVICE VIEWS AND CONNECTIONS ............................................................................ 17
5.1. View of the device front ................................................................................................ 17
5.2. View of the rear side of the device ............................................................................... 21
5.3. Explanation of signs and symbols on the devices ........................................................ 22
6. COMMISSIONING............................................................................................................. 24
6.1. Important notes ............................................................................................................ 24
6.2. Warning on commissioning the device after storage in cold areas or transport during
cold weather ................................................................................................................. 24
6.3. Safety instructions ........................................................................................................ 24
6.4. Mains connection ......................................................................................................... 24
6.5. Mains switch ................................................................................................................. 24
6.6. Installation .................................................................................................................... 24
6.6.1. Connecting the pneumatic foot switch .................................................................. 24
6.6.2. Connecting the stimulation coil ............................................................................. 25
6.6.3. Mains connection and switching on the device..................................................... 26
6.6.4. Connecting the optional pulse trigger ................................................................... 26
6.7. Positioning instructions ................................................................................................. 28
6.8. Switching on ................................................................................................................. 28
6.9. Operating mode: Intermittent mode ............................................................................. 29
7. OPERATION: QUICK GUIDE ........................................................................................... 30
7.1. Releasing single pulses ................................................................................................ 31
7.2. Releasing a pulse sequence ........................................................................................ 31
8. OPERATION: DETAILED INSTRUCTIONS ..................................................................... 33
8.1. Manual operation .......................................................................................................... 33
8.1.1. Safety limits .......................................................................................................... 33
8.1.2. Pulse intensity....................................................................................................... 33
8.1.3. Pulse shape .......................................................................................................... 34
8.1.4. Pulse frequency .................................................................................................... 34
8.1.5. Pulse sequence duration ...................................................................................... 34
8.1.6. Pulse release ........................................................................................................ 34
8.1.7. Saving and restoring the settings ......................................................................... 35
8.1.8. Pulse polarity ........................................................................................................ 35
8.1.9. Coil temperature ................................................................................................... 35
8.1.10. Precision indicator ................................................................................................ 35
8.1.11. Standby mode....................................................................................................... 36
8.2. External control ............................................................................................................ 36
8.2.1. External triggering................................................................................................. 36
8.2.2. Full external control .............................................................................................. 37
9. ERROR MESSAGES AND MEASURES IN CASE OF FAULTS ...................................... 40
10. CLEANING AND CARE..................................................................................................... 41
Page 2 February 2010 rTMS

10.1. Cleaning the device and the coil ...................................................................................41
10.2. Disinfecting the device ..................................................................................................41
11. MAINTENANCE .................................................................................................................42
11.1. Replacing fuses ............................................................................................................42
11.2. Maintenance instructions / recurring safety checks according to the German medical device
operator ordinance (MPBetreibV) § 6 ..............................................................................42
11.3. Repairs .........................................................................................................................43
11.4. Enhancements and modifications .................................................................................43
12. ENVIRONMENTAL PROTECTION ...................................................................................45
12.1. Emissions or waste materials .......................................................................................45
12.2. Disposal ........................................................................................................................45
13. ACCESSORIES .................................................................................................................46
14. SPECIFICATIONS .............................................................................................................47
14.1. rTMS .............................................................................................................................47
14.2. General specifications ..................................................................................................48
14.3. Plug connector and socket allocations .........................................................................49
14.3.1. Mains connection socket .......................................................................................49
14.3.2. Coil socket.............................................................................................................49
14.3.3. Analogue interface socket .....................................................................................50
14.3.4. Digital input ...........................................................................................................50
14.3.5. Digital output .........................................................................................................51
14.3.6. Potential equalisation ............................................................................................51
14.3.7. Synchronisation output ..........................................................................................51
14.3.8. Connection socket for optional pulse trigger .........................................................52
14.4. Information regarding the electromagnetic compatibility of the rTMS ..........................53
14.4.1. Guidelines and manufacturer's declaration – electromagnetic emissions ............53
14.4.2. Guidelines and manufacturer's declaration – electromagnetic immunity ..............54
14.4.3. Guidelines and manufacturer's declaration – electromagnetic immunity ..............55
14.4.4. Recommended safety distances between portable and mobile HF
telecommunications devices and the rTMS ..........................................................56
15. CERTIFICATION ...............................................................................................................57
APPENDIX ...................................................................................................................................59

IDENTIFICATION
1. Identification
Model name: PowerMAG 30 (30 Hz Stimulator)
PowerMAG 100 (100 Hz Stimulator)
PowerMAG 30 research (30 Hz research stimulator)
PowerMAG 100 research (100 Hz research stimulator)
hereafter referred to as rTMS
(Example type plate):
Manufacturer: Heitec AG
D-91052 Erlangen
Tel. +49 (0)9131 877-0
Fax +49 (0)9131 877-199
www.heitec.de
MPG classification Class IIa

(German Medical Devices Act):
MP BetreibV classification MP BetreibV Annex 1

(German Medical Device
Operator Ordinance):
Electrical protection class Protection class 1 (Protection type BF)

according to IEC 60601-1
Device designation: Magnetic field therapy device
UMDNS code: 12-415

INTENDED USE
2. Intended Use
Type of device: Repetitive Magnetic Stimulator (rTMS)
Device usage: Diagnostic and therapeutic device
Application area: Clinical and scientific studies and applications in the

neurosciences (neurology, neurosurgery,
neurorehabilitation, psychiatry, etc.) as well as related
areas; for both stationary and ambulatory use in research,
in the clinic and in the practice.
Users: Medically trained personnel, medical engineers, doctors
Contraindications: See chapter 3.2. "Contraindications"

WARNINGS AND SAFETY INSTRUCTIONS
3. Warnings and safety instructions
This medical device and the accessories approved for use with it fulfil the rules of the
German Medical Device Act (MPG), particularly in regard to safety and electromagnetic
compatibility. This is also documented by the CE marking and a corresponding declaration
of conformity.
We, Heitec AG, only consider ourselves as liable for the safety, reliability and usability of the
described device/system if:
⇒ assembly, instruction, maintenance, readjustments or repairs are performed exclusively
by medical engineers and medical device consultants trained by Heitec AG;
⇒ the electrical installation of the room in question conforms to the applicable
requirements;
⇒ the device/system is used in adherence with the operating manual and
⇒ only the consumables and accessories approved by us are used.
Operation with accessories other than those approved as well as alterations or additions to
hardware are only permitted if our prior written approval is provided, the necessary
inspections are performed, recorded and communicated to us and we have amended the
declaration of conformity specific to the serial number accordingly.
In the case of enhancements and modifications to hardware which have been performed
without written approval and without altering the device-specific declaration of conformity,
any warranty becomes null and void (see Directive 93/42/EEC).
Before assembly and commissioning of the rTMS, please read this operating
manual carefully so that you can operate your rTMS safely and without error.
3.1. The basics

The rTMS magnetic stimulator was developed, produced and tested in accordance with the
IEC publication IEC 60601-1 "Medical Electrical Equipment". It corresponds to protection class
I, type BF.
Devices of protection class I are to be designed so that the safety of patients and operators is
assured by the protective earth conductor in case of error. The rTMS magnetic stimulator may
only be operated on an electrical installation in accordance with DIN VDE 0100-710:2002.
In order to maintain the device safety as well as for the assurance of safe operation, the
instructions and warnings provided in this operating manual must be observed without fail!

The following safety instructions must be observed, in particular:
• Danger to life! The stimulation coil must be carefully

inspected for cracks or other damage before each use. The
device may only be operated safely if the coil is in perfect
condition! A defective coil can make life-threatening high
High voltage voltages accessible during operation.
on the damaged coil
• There is a risk of electric shock at the free, unoccupied

coil socket (Fig. 3-1)! Do not touch!
• The device may only be switched on with a coil plugged
in!
High voltage • The coil may not be unplugged or replaced while the
at the coil socket device is switched on!
Figure 3-1: Coil socket on the front panel of the rTMS
When opening the stimulator while it is connected to the mains, live parts become accessible.
This creates a life-threatening situation! Any measures which necessitate opening the
stimulator or the use of tools on the device (such as inspection, maintenance, repair) may only
be performed by the manufacturer! Even after disconnection from the mains (removal of the
mains plug) a life-threatening situation persists for a few minutes, because the energy stores in
the device require a certain amount of time to discharge.
• Danger to life! The device may only be opened by the

manufacturer!
• Warranty claims become null and void on opening.
High voltage
in the device

3.2. Contraindications of use
• The rTMS may not be used near external equipment with a

life-sustaining or supporting function. Use of this
procedure is prohibited for users, patients, test subjects
and/or third parties with implanted medical devices (e.g.
Medical device pacemakers, medication pumps).
• Direct use on the heart is not permitted.
Use on the heart
The use of the rTMS is prohibited for patients or test subjects
• with metal implants in the head area, e.g. shunts, clips (for patients with metallic implants
or similar objects in the vicinity of the point of treatment, the user must weigh the potential
risk against the utility of the treatment)
• with implanted medical devices (cochlear implant, medication pump, pacemaker, etc.)
• during pregnancy (in this case the magnetic nerve root stimulation is of critical importance;
the transcranial stimulation is less critical on the basis of the greater distance to the
foetus)
• with increased intracranial pressure (e.g. after trauma or infection)
• with a history of epileptic seizures (only applies for the cortical use; if necessary a
risk/benefit analysis should be performed)
3.3. Residual risks and safety guidelines

The single pulse TMS is classified by experts as a safe method. The rTMS, on the other hand,
entails potential risks, because it can inhibit or promote cortical processes. The greatest known
risk is of epileptic seizure. After seven seizures came to light in patients treated with rTMS, an
international workshop was organised in June 1996 to determine the safety risks. Since the
introduction of these safety guidelines, no additional incidents have been reported.
Therefore, these guidelines appear to be a suitable basis for the safe use of magnetic
neurostimulation according to the current state of knowledge. Original information in the
appendix:
Wassermann: Risk and Safety of repetitive transcranial magnetic stimulation: report

and suggested guidelines from the International Workshop on the Safety of Repetitive
Transcranial Magnetic Stimulation
• TMS laboratories must be equipped with a couch!

• Treat seizures according to the ABC rule (Airway-
Breathing-Circulation)!
• In the case of an epileptic seizure of the patient/test
subject, the user must ensure that the patient/test subject
cannot injure themselves.
Epileptic seizure

• Individually adjust safety limits before each treatment!
Safety limits
3.4. Safe operation of the rTMS
• The classification and recognition of the correct

stimulation point is solely the user's responsibility and
must be achieved with care.
Stimulation point
The following applies as a basic rule for the selection of the stimulation parameters: The
magnetic stimulation should be performed with
• the lowest possible impulse strength,
• the lowest possible frequency,
• the shortest possible treatment duration and
• the lowest possible number of pulses per patient (no more than 10,000 per day, if
possible)
in order to respond to the diagnostic problem or achieve the desired therapeutic effect.
If the rTMS dosage is too high (high pulse rate on the cortex), epileptic seizures can result.
The rTMS should be operated by doctors with experience in epileptology under conditions that
permit the recognition and treatment of epileptic seizures.
In order to minimise the risk of epileptic seizure, the safety limits must be individually adjusted
before each treatment. A guideline for adjusting the intensity and frequency safety limits can
be found in the appendix, Table 1.
This concerns maximum values which the device will emit irrespective of other specifications.
These values have the highest priority. This means when critical values are requested in the
case of operating error (e.g. stronger single pulse is emitted to the brain at an unintended high
frequency -> danger of an epileptic seizure), the safety limits cannot be exceeded. Such an
operating error is indicated both visually (Alarm LED on the front panel) and audibly (loud
alarm tone) and, as a result of this safety function, has no effect on the test subject/patient.
The step size of the safety limits was selected according to safety-critical and physiological
considerations.
The selection of the maximum pulse intensity takes place in the increments 25, 40, 55, 70, 85,
100. In the lower range, an intentionally larger step size was selected, because experience has
shown that the human stimulus threshold lies above 20%.
The selection of maximum pulse frequency takes place in the increments 0.2 / 1 / 2 / 5 / 10 or
maximum frequency (30 Hz for PowerMAG 30, 100 Hz for PowerMAG 100; the type plate on
the rear side indicates the device type). A fine incrementation was intentionally selected in the
lower frequency range (0.2 / 1 / 2 and 5 Hz). This is necessary so that the rTMS is safe
(repetitive use on the cortex) (Table 1 in the appendix).
Additional stimulation parameters, such as total number of pulses, duration of a pulse series
(train), duration of pause between the series (inter-train interval), etc. are not a component of
the safety limits to be adjusted, because a safe setting is not realistic on the basis of the
numerous combination possibilities. This selection must be made by the doctor on an
individual basis after a careful risk/benefit analysis.

The minimum distance of magnetically-sensitive objects (watches,

credit cards, data storage devices (USB flash drive), computers,
monitors, etc.) to the stimulation coil is 1m. Otherwise, damage or
data loss cannot be ruled out. This minimum distance applies, in
general, for all (metallic) objects that react to magnetic fields.
Minimum distance Similarly, the stimulation coil may not be placed on metal surfaces.
During operation of the coil, a safety distance of 30 cm to the

device must be maintained. In addition, the coil should not be
placed on the switched-on device.
Distance from the coil to
the stimulator
Before commissioning, it must be ensured that the mains voltage

is according to the rating plate and that the outlet for connection of
the device is fused for a current of 16 A.
As a basic rule, operation is only permitted using outlets with an
Commissioning earth contact. Extension cords may not be used.
• Before any type of cleaning, maintenance or terminal assignment (replacing the

stimulation coil), the stimulator must be disconnected from the voltage source.
• As a basic rule, fuses in the device may only be replaced with the respective prescribed
type with the indicated rated current and tripping characteristic. In particular, the
installation of "patched fuses" and connection of any electrical components or
connections to the contacts of the fuse holder are prohibited, with the exception of the
prescribed fuses.
• In cases where the stimulator is electrically connected to other equipment, the provisions
of the publication IEC 60601-1-1 (see chapter 8.2) Collateral Standard: "Safety
Requirements for Medical Electrical Systems" must be observed.
It is to be assumed that safe operation of the magnetic stimulator is no longer assured if:
• damage to the device is visually recognisable,

• the device no longer operates in the usual manner,
• the device was stored under unfavourable conditions beyond the limit values in chapter
14.2 (e.g. penetration of moisture, heavy vibrations and impact, high content of dust and
suspended matter in the ambient air, corrosive vapours or media, etc.).
It is prohibited to disconnect the protective earth electrically, because this poses a hazard. The
protective earth connection must be inspected within the scope of statutory safety checks
every 24 months (chapter 11.2).
Before unplugging the stimulation coil, as well as before the replacement of the stimulation
coil, the stimulator must always be switched off in order to prevent people or equipment from
being endangered. At the end of a stimulation session or treatment, the pulse intensity as well
as the pulse frequency must always be set to minimum output.

3.5. Measures for maximum patient safety

• The potential risks must be explained to the patient or test
subject before the treatment.
• The patient or test subject must always be capable of
specifying their wish to discontinue stimulation to the
device user.
Discontinue stimulation
• During a stimulation session, continuous communication between the user and patient
or test subject is necessary so that a looming seizure can be recognised at the earliest
possible stage, and treatment discontinued. The patient or test subject must be capable
of expressing that they are feeling unwell.
• The treatment coil is in direct contact with the body (skin, hair, clothing) of the patient or
test subject during a stimulation session. Since the coil heats up during treatment, the
patient must have sufficient sensitivity to temperature at the part of the body to be
treated and must also be capable of informing the doctor when the temperature is too
high.
• Should the coil treatment take place while pulses are being emitted by nearby EEG
electrodes, radially slotted electrodes should be used in order to avoid heating the
electrodes and causing burns to the skin.
• In order to prevent induction of current in the EEG electrode cables, they should be led
away from the electrodes without bends and kinks.
• During the examination of healthy test subjects, an EEG should be taken before the
rTMS in order to cover any inclination toward seizure. The test subjects to be examined
must not be tired and should not have hypoglycaemia.
• Patients or test subjects with a history of epileptic seizures should not receive cortical
stimulation (see chapter 3.2. Contraindications).
• The user must actuate the pneumatic foot switch in order to enable the release of
stimulation pulses at the front panel and/or by external interface. This prevents pulses
from being emitted unintentionally.
• The risk of a hearing threshold change induced by rTMS through the acoustic artefact
can be reduced by using earplugs.
• In the case of impermissible heating of the stimulation coil above 41°C, the magnetic
stimulator is deactivated by a protective circuit (see Error messages and measures in
case of faults).
3.6. Safety note for the trolley

If the trolley is used, both parking brakes on the front castors must be locked as soon as the
device is in position.
Positioning on an inclined surface is discouraged. If the trolley must be positioned on an

inclined surface, however, the front brake wheels must always be positioned at the lowest point
(downwards). Both wheels must always be locked.

3.7. Liability of the manufacturer

Heitec AG is only liable for the effects on the safety, reliability and performance of the
equipment if the following provisions are adhered to:
• Assembly, enhancements, modifications or repairs may only be performed by persons

who have been authorised by Heitec AG.
• The electrical installations of the room in question comply with the requirements of the
IEC regulations (DIN VDE 0100-710:2002 or IEC 60634-7-710:2002 cf. chapter 11.4).
• The device must be used in accordance with this operating manual.

DESCRIPTION OF THE SYSTEM
4. Description of the system
4.1. Physical operating method

The medical application of the rTMS is described in general as magnetic stimulation. Magnetic
stimulation is a non-invasive, almost painless method through which it is possible to influence
the electrical activity (activation or repression) of the nerves using a time-variable magnetic
field according to the physical principle of induction.
The process requires a coil which is placed close to the skin’s surface, as well as a stimulatory
device that provides the coil with a supply of electricity and assumes control of the current flow.
A magnetic field generated by the stimulation coil, which changes rapidly during the application
period, penetrates the tissue and effects the induction of a voltage in electrically conductive
areas – comparable to the principle of an electrical transformer.
When using the device, no special preparation is required for the skin surface; the device can
cause stimulation through clothing, hair, etc. Deep-lying areas can be reached, because the
magnetic field penetrates bone structures such as the skullcap. This range of depth, however,
is limited to a few centimetres.
Successful stimulation depends on the strength and positioning of the electrical field induced
by the stimulation coil and the pulse shape supplied by the stimulator.
The determined stimulus thresholds, however, only apply for one examination session,
because they depend heavily on the physiological constitution of the patient (fatigue,
nervousness, blood sugar level).
In common with all stimulators currently available on the market, the so-called impulse strength
of the magnetic stimulator is emitted at a percentage relative to the device's maximum value.
This percentage is based directly on the applied discharge voltage. In other words, it is directly
proportional to it.
4.2. Motor threshold
Both cortical and peripheral excitability vary from one patient or test subject to the next. In
order to make the procedure of magnetic neurostimulation comparable, the intensity of
stimulation is normalised with regard to the motor stimulus threshold of the individual. The
individual stimulus threshold is determined by a TMS of the motor cortex. The motor cortex is
the only region in which a direct, measurable physiological effect appears after stimulation in
the form of the compound muscle action potential (CMAP).
The motor threshold (MT) is defined as the minimum impulse strength which suffices to
generate a small muscle action potential (MAP > 50µV) in the relaxed muscle, e.g. abductor
pollicis brevis (APB), in at least half of all cases (normally 8-10 cycles). For this reason, this
threshold gained in the relaxed muscle is called the resting motor threshold (RMT). The active
motor threshold (AMT) is determined in the same manner in the tense muscle and normally
lies around 5-20% below the RMT.
An adjustment of the stimulation intensity to the individual cortical motor threshold (e.g. 110%
MT - stimulation above threshold, 90% MT - stimulation below threshold) enables a certain
standardisation of the biological efficiency of the TMS between subjects.

DESCRIPTION OF THE SYSTEM
Practical implementation:
Since only single pulses are needed, a stimulation frequency of 0Hz should be selected. The
examination begins with exploratory coil positioning. As a starting point, the centre point of the
coil (the so-called hot spot) should be positioned above the primary motor hand area. The
approximate position of the hand area is 4-5 cm lateral and 1-2 cm anterior to the vertex.
Figure 4-1: Coil positioning for the motor

threshold determination
4.3. Pulse shapes
The pulse shape is available as a half-wave or full-wave. The half-waves are emitted from the
device in an alternating sequence. When switching on the device and/or returning from
standby mode, it always starts first with a positive half-wave or full-wave.
Figure 4-2: Direction of the coil current with a positive full-wave. The
maximum electrical field lies below the coil centre point.

DEVICE VIEWS AND CONNECTIONS
Figure 4-3: Direction of the coil current with a negative full-wave. The
maximum electrical field lies below the coil centre point.
The type and position of the coil as well as the variation in time of the coil current are to be
selected so that the relevant stimulus threshold at the target location of the stimulation is not
exceeded in regard to the desired effect (see chapter 4.2 Motor threshold).

5. Device views and connections

The illustrations of the hardware correspond to the status at the time of the creation of this
operating manual. The hardware may be changed as a result of adaptations in line with the
latest technological standards.
5.1. View of the device front

In the following Figure 6-1, the front view of the rTMS is depicted. The individual elements are
identified with letters. Their function is described in the list below.
Figure 6-1: Illustration of the front panel of the rTMS
Warning information
Individually adjust The device may only

safety limits before each be operated with the
treatment coil plugged in
(see chapter 3.4.) (see chapter 3.1.
and chapter 6.6.2.)
Switching on
A Operation LED Illuminates when the stimulator is switched on (ON switch
on the rear side), indicating that the device is in operation
(Operation)
B Operating mode selector For selecting the operating mode: Manual operation via
the front panel (Front Panel) or external control. (External).
switch

Connections
C Stimulation coil socket Connection socket for the stimulation coil -
CAUTION! The coil must be plugged in before switching
on. Adherence to the safety instructions (chapter 3.1.) as
well as the connection instructions (chapter 6.6.2) is
mandatory.
Note: Signs and symbols are explained in chapter 5.3.

D Socket for foot switch Connection socket for pneumatic safety foot switch
ac Socket for optional pulse Connection socket for optional pulse trigger (hand or foot
switch)
trigger
Safety limits
E Intensity limiter Rotary switch - limits the pulse intensity in the increments
25, 40, 55, 70, 85, 100% (Intensity [%])
F Frequency limiter Rotary switch - limits the device's internal frequency in the
increments 0, 2, 1, 2, 5, 10 and maximum frequency
(30Hz for PowerMAG 30, 100Hz for PowerMAG 100)
(Frequency [Hz])
G Alarm LED Illuminates when the set limit values (E, F) are exceeded
(Alarm); the audible alarm sounds simultaneously
Coil temperature
H Coil temperature indicator Displays the temperature of the stimulation coil. In the
case of excess temperatures (> 41°C), the indicator light
for 40°C flashes; if the coil temperature is insufficient, the
indicator light for 18°C flashes. In both cases, the device is
barred from releasing a pulse. (Coil Temperature)
Intensity
I Intensity dial For setting the pulse intensity from 0-100% of the
maximum pulse voltage in increments of 0.5%
J Intensity display Displays the selected pulse intensity (I) as a percentage of
the maximum pulse voltage.
A flashing display means that the device is in standby
mode. To bring the device out of standby mode, press any
one of the controls.
In addition, the display can show the following messages:
„----”: External control active
"Coil": No stimulation coil plugged in
"°C": Device overheating
"Err0 to Err9": Internal device error has occurred
K Precision LED The precision LED (Precision) indicates whether the
internal device pulse voltage controller is capable of
emitting the pulse with the desired intensity (green light) or
not (red light).

Frequency
L Frequency/duration selector For selecting between the display/setting of pulse
switch frequency or maximum pulse sequence duration
M Frequency/duration LEDs Indicate whether the pulse frequency (LED labelled with
Hz) or the maximum pulse sequence duration (LED
labelled with Sec) is shown in the frequency/duration
display O. This can be selected using the
frequency/duration selector switch L.
N Frequency/duration dial For setting the value currently shown for pulse frequency or
maximum pulse sequence duration in the frequency/duration
display O (you can switch between the two variables with the
frequency/duration selector switch L)
Pulse frequency:
0 Hz (single pulse)
0.1 to 1.0 Hz in increments of 0.1 Hz
1 to 30 Hz in increments of 1 Hz
Max. pulse sequence duration:
1- 180 sec in increments of 1 sec
"--": no limit on the pulse sequence duration
O Frequency/duration display Displays the value currently set for pulse frequency or
maximum pulse sequence duration (you can switch
between the two variables with the frequency/duration
selector switch L) (Frequency / Duration)
(Display "--": no limit on the pulse sequence duration)
Pulse
P Pulse shape selector switch For selecting the pulse shape to be emitted
Q Pulse shape indicator LEDs Indicate the selected pulse shape.
R Pulse triggering switch Releases pulses which have the values selected for pulse
shape, pulse intensity and stimulation frequency.
Repetitive pulse emission takes place as long as the R
switch or an optionally connected hand or foot switch (ac
connection socket) is pressed. If a maximum pulse
sequence duration is set, the pulse emission is continued
after this period has elapsed (also if a button is still being
pressed).
The LED of the pulse button illuminates as soon as
pulsing is possible.
S Store button Stores the set values for pulse intensity, pulse shape,
stimulation frequency and maximum pulse sequence
duration (Store). The values are also retained when the
device is switched off and are available again when it is
switched back on.
T Recall button Recalls (Recall) the values for pulse intensity, pulse
shape, stimulation frequency and maximum pulse
sequence duration which were saved with the store button
S.

U Positive polarity LED Illuminates if the polarity (Polarity) of the next half-wave
pulse will be positive or the next full-wave pulse will begin
with a positive half-wave. If the positive polarity LED does
not illuminate, the next pulse will be a negative half-wave
or full-wave.
Note: After standby mode, the first pulse (half-wave or full
wave) is always positive.

5.2. View of the rear side of the device

In the following Figure 6-3, the rear side of the rTMS is depicted. The individual elements are
identified with letters (Figure 6-4). Their function is described in the list below.
Figure 6-3: Schematic diagram of the rear panel of the rTMS
Switching on
V ON/OFF operating switch Mains switch for switching on the device
Connections
W Mains connection Connection socket for the mains cable
X Trigger IN Trigger input for pulse release via external trigger signal
Y Trigger OUT Trigger output for signal impulse for pulse emission
Z Analogue interface socket Inputs: Pulse shape (0 V or 5 V), pulse intensity

(0 to 5 V)
Outputs: Precision (0 V or 5 V), coil temperature (0 to 5 V)
Other
aa Fuses Fuse holder for mains fuses 2 x 6.3 A T
ab Potential equalisation pin Potential equalisation pin for potential equalisation

between various devices.
ad Sync Out Synchronisation Output (4 MHz)

ae covering cap Covering cap for Sync Out connector
af type plate Type plate for identification (refer to chapter 1)
5.3. Explanation of signs and symbols on the devices
Warning note: Caution, observe accompanying paperwork!
High voltage! Risk of electric shock! Do not touch!
Temperature in °C
Half-wave
Full-wave
Connection for the pneumatic foot switch
Device type BF ("Body Floating");

B – The device has special protection against electric shock,
especially in regard to the permissible leakage current and the
reliability of the protective earth conductor connection
F – The device has an insulated (floating) application part
(stimulation coil)
External trigger source output

External trigger source input
External interface
The device may only be opened by the manufacturer
Before performing pin assignment, refer to the operating manual
Potential equalisation pin

COMMISSIONING
6. Commissioning
6.1. Important notes

The proper condition of the device must be ensured each time before it is switched on. The
device may only be switched on if no (mechanical) damage which could jeopardise the safety
of the user or patient is recognisable.
The device is not suitable for operation in potentially explosive areas.
• Danger to life! The stimulation coil must be carefully

inspected for cracks or other damage before each use. The
device may only be operated safely if the coil is in perfect
condition! A defective coil can make life-threatening high
High voltage on the voltages accessible during operation.
damaged coil
6.2. Warning on commissioning the device after storage in cold

areas or transport during cold weather
The ambient temperature for operation of the device lies between 10°C and 40°C. Therefore,
the rTMS must be allowed to reach room temperature before it is switched on (at least 24 hrs
is recommended).
Never use electrical fan heaters or other heating equipment in order to speed up the process;
this could lead to the formation of condensation in the device and result in malfunctions.
6.3. Safety instructions

Please carefully read and observe the safety instructions listed in chapter 3! The operating
manuals of the auxiliary equipment (control devices, etc.) must also be observed.
6.4. Mains connection

The rTMS should be connected to the mains via a wall socket, using the supplied mains cable
with plug.
Additional, movable multi-socket power strips or extension cords may not be connected to the
system.
6.5. Mains switch

The mains switch for switching on the device is located on the rear side of the housing.
6.6. Installation
6.6.1. Connecting the pneumatic foot switch
The pneumatic foot switch is connected to connection socket D on the front panel. This occurs
by pulling the hose of the foot switch through the connecting piece until it stops and screwing it
tightly into place with the coupling nut. The pneumatic foot switch must not be pressed during
installation.

COMMISSIONING
Figure 6-5: Connection socket for the pneumatic foot switch on the front panel of the rTMS
6.6.2. Connecting the stimulation coil
• There is a risk of electric shock at the free, unoccupied

coil socket (Fig. 3-1)! Do not touch!
• The coil may not be unplugged or replaced while the
High voltage device is switched on!
at the coil socket
The stimulation coil is connected to connection socket C on the front panel.

In order to connect the coil to the coil socket, rotate the coil plug connector to the upright
position (wide guide-notch facing towards the top, Fig. 6-6) and carefully guide it into the coil
socket on the front panel. Do not apply force. The contact pins are extremely sensitive! After
fitting the plug, lock the silver coupling nut by turning it to the right. This pulls the plug further
into the socket (bayonet connection). After the coupling nut locks into position the plug is
completely connected to the coil socket.

COMMISSIONING
Figure 6-6: Diagram of the coil plug connector; the black circles symbolise the contact pins; the wide
guide notch is recognisable on the coil plug connector as well as on the coil socket on the front panel.
6.6.3. Mains connection and switching on the device

The connection of the stimulator to the mains (earth contact socket, mains voltage refer to
rating plate, circuit fused with at least 16 A) may only be made though the supplied mains
cable (item number 886036). The plug of the mains cable is to be plugged into the IEC socket
W (Figure 6-7) located on the rear side of the device which is labelled with the inscription
Netzanschluss (mains connection).
Figure 6-7: Mains plug connector, fuse holder and ON/OFF switch on the rear side of the device
6.6.4. Connecting the optional pulse trigger

The optional pulse trigger (available in a hand or foot switch variant) is connected to the
connection socket ac on the front panel. Its connector is locked in place by means of a screw
closure.

COMMISSIONING
Hand switch Foot switch with protective hood

COMMISSIONING
6.7. Positioning instructions

• Use within dry, enclosed areas (room temperature between +10°C and +40°C).
• Protect against vibration; and use on a stable and level surface
• Provide sufficient ventilation (ventilation slits on the rear side and lateral sides may not
be covered; minimum clearance of 10 cm on all sides)
• Ensure sufficiently distance (1.0 m) from sensitive electronics (see section on safety)
• Do not position in direct sunlight
• After transport or storage outside of the normal operating conditions (see chapter 14.2),
acclimatisation under normal operating conditions for at least 24h is necessary. In doing
so, sufficient ventilation must be ensured.
• The device is not intended to be operated in potentially explosive areas. When explosive
anaesthetic gases (flammable mixtures of anaesthetics with air or nitrous oxide) are
being used, the device may not be operated in this danger zone.
• Positioning of the trolley on an inclined surface is discouraged. If the trolley must be
positioned on an inclined surface, however, the front brake wheels must always be
positioned at the lowest point (downwards). Both wheels must always be locked.
6.8. Switching on
The safety instructions in chapter 3 must be read carefully before
commissioning the device!
Before the stimulator is connected to the mains (connection

socket W) and/or switched on, it must be ensured that the
stimulation coil is correctly connected to the stimulation coil
socket C (cf. chapter 6.6.2). In the process, it must be
checked whether the coupling nut of the plug connector is
completely tightened (by turning clockwise).
The stimulator is switched on with the mains switch V located on the rear side. All LED
indicators briefly illuminate. After five seconds (Alarm LED G and audible alarm activate) the
Operation LED A located on the front side indicates operational readiness.
The functionality of all LEDs, particularly the alarm function

must be critically inspected each time the device is switched
on. The audible alarm is activated for 5 seconds and switches
off automatically.
The pneumatic foot switch must be released when switching

on the device.

COMMISSIONING
6.9. Operating mode: Intermittent mode

The rTMS is suitable for continuous operation. The limiting factor, however, comes in the
heating of the coil. The higher the selected intensity and frequency pulse parameters, the
faster the coil heats up. With a coil temperature of 41°C or higher, the stimulator is blocked
from emitting pulses. This intermittent mode is configured to 120 sec / 8 min, meaning with
maximum output parameters (100% intensity, 30 Hz or 100 Hz frequency, full-waves), the
duration of the pulse sequence must be decreased to 120 seconds. Afterwards a wait time of 8
minutes is necessary.
The Trigger IN, Trigger OUT connections, as well as the

analogue interface (X, Y and Z) make low voltages
accessible to the touch. For safety purposes, these
connections should not be touched while also touching the
patient / test subject.
The rTMS, as well as the connected accessories may only be

used in areas used for medical purposes which have
electrical installations according to the applicable provisions
(e.g. DIN VDE 0100-710:2002 or IEC 60364-7-710:2002).
The relevant guidelines of the employer's liability insurance
association and equally-ranking organisations must be
observed.

OPERATION: QUICK GUIDE
7. Operation: Quick guide

Remark: The elements mentioned in the following quick guide are described in detail in
chapter 5.1. The schematic diagrams of the front and rear panels are repeated here for
illustration purposes (Figure 7-1 and Figure 7-2).
Figure 7-1: Schematic diagram of the front panel of the rTMS
Figure 7-2: Schematic diagram of the rear panel of the rTMS

7.1. Releasing single pulses

1. Switch on the device - Caution! The stimulation coil must be plugged in! The pneumatic
foot switch must be connected. When using the optional pulse trigger (hand switch or
foot switch with protective hood), switch it on as well.
2. Set safety limits F and E according to the treatment type.
3. Move the interface selector switch B to the Front Panel position.
4. Select the desired pulse intensity (display J Intensity [%]) with the pulse intensity dial I.
5. Select the desired pulse shape (indicators Q) with the pulse shape selector switch P.
6. Switch to the frequency display mode (indicator M) with the frequency/duration selector
switch L.
7. Set the pulse frequency 0 Hz (display O Frequency / Duration) with the
frequency/duration dial N.
8. If standby mode is active (pulse intensity is displayed flashing, display J), press any
button in order to bring the device out of this mode.
Note: After standby mode, the first pulse is always positive.
9. Actuation of the pneumatic foot switch enables the coil.
10. By actuating the pulse button R (Pulse), a single pulse is emitted. The optional foot
switch (yellow with protective hood) or the optional hand switch (black with coiled cord)
can also be used to emit a single pulse (connection to ac). The pulse button R always
illuminates for pulse readiness.
7.2. Releasing a pulse sequence

1. Switch on the device - Caution! The stimulation coil must be plugged in! The pneumatic
foot switch must be connected. When using the optional pulse trigger (hand switch or
foot switch with protective hood), switch it on as well.
2. Set safety limits F and E according to the treatment type.
3. Move the interface selector switch B to the Front Panel position.
4. Select the desired pulse intensity (display J Intensity [%]) with the pulse intensity dial I.
5. Select the desired pulse shape (indicators Q) with the pulse shape selector switch P.
6. Switch to the frequency display mode (indicator M) with the frequency/duration selector
switch L.
7. Select the desired pulse frequency (display O Frequency / Duration) with the
frequency/duration dial N.
Frequencies above 30 Hz (only with PowerMAG 100, see type plate on rear side) are
automatically emitted from the device as a theta burst pulse in front panel mode (B in
Front Panel position), which means three pulses at the selected intensity and frequency
are always repeated with a 5 HZ carrier frequency. This theta burst mode is indicated to
the operator by the frequency display (display O Frequency / Duration) flashing twice
after the target frequency has been set.
The following maximum intensities are available in the frequency range 0 to 100 Hz:
0 to 30 Hz: 100% intensity (PowerMAG 30)


If frequencies >30 HZ are requested with a higher intensity, the maximum possible
intensity is automatically indicated by the intensity display (display J Intensity [%])
flashing twice.
8. Switch to the duration display mode (indicator M) with the frequency/duration selector
switch L.
9. Select the desired pulse sequence duration with the frequency/duration dial N.
10. If standby mode is active (pulse intensity is displayed flashing, display J), press any
button in order to bring the device out of this mode.
11. Actuation of the pneumatic foot switch enables the coil.
12. By actuating the pulse button R, or alternatively the optional hand switch or foot switch
with protective hood (connection ac), the desired pulse sequence is emitted as long as
the respective button is pressed. On reaching the set pulse sequence duration, the
pulse emission is automatically continued (also if a button is still being pressed). The
pulse button R always illuminates for pulse readiness.

OPERATION: DETAILED INSTRUCTIONS
8. Operation: Detailed instructions

In order to control the magnetic stimulator the following control options can be selected with
the interface selector switch B:
• Front panel (Front Panel): manual pulse release via the front panel
• External (External): external control via analogue interface (rear panel connection
Z)
8.1. Manual operation

8.1.1. Safety limits
The maximum possible pulse frequency (Frequency [Hz]) and pulse intensity (Intensity [%])
pulse parameters are set based on the safety limits F and E. The limit for the pulse frequency
can be set to 0.2, 1, 2, 5, 10Hz or max. The maximum (max) pulse frequency depends on the
stimulator type (for PowerMAG 30 – 30Hz, for PowerMAG 100 – 100Hz). The stimulator type
can be determined from the type plate (rear side). The limit for the pulse intensity can be set to
25, 40, 55, 70, 85 or 100%. The safety limits must be set carefully prior to each stimulation
session. The device is restricted to these parameters - it is not possible to emit pulses with
higher parameters. If pulse parameters which exceed the safety limits are requested (front
panel: I and N; rear panel: Z), an audible alarm signal sounds. The Alarm LED G also
illuminates.
Chapter 3.4. Ensure safe operation of the rTMS.
Note
8.1.2. Pulse intensity

The intensity of the stimulation pulse to be emitted can be set with the pulse intensity dial N.
Settings from 0-100% of the maximum pulse voltage can be made in increments of 0.5%. The
selected value is shown on the pulse intensity display J.
The pulse intensity can also be changed during the emission of a pulse sequence.
Device type PowerMAG 30 (rear-side type plate): 100% intensity is available over the entire
frequency range from 0 to 30 Hz.
Device type PowerMAG 100 (rear-side type plate): just like the PowerMAG 30 in the frequency
range 0 to 30 Hz; frequencies above 30 Hz are restricted by the device:
35 to 50 Hz: 80% intensity

If frequencies >30 Hz are requested with a higher intensity, the maximum possible intensity is
automatically indicated by the intensity display (display J Intensity [%]) flashing twice.

8.1.3. Pulse shape

The pulse shape to be emitted can be selected with the pulse shape selector switch P. It is
possible to select from half-wave or full-wave pulses. The pulse shape indicator LEDs M show
the selected pulse shape.
For half-waves, pulses with positive and negative polarity are emitted alternately. Positive
polarity is indicated by the positive polarity LED U.
8.1.4. Pulse frequency

The desired stimulation frequency can be selected with the frequency/duration dial N. To do
so, switch to the frequency display mode (LED indicator M: Hz) with the frequency/duration
selector switch L. The selected value is shown in the frequency/duration display O.
The pulse frequency can be selected in the following ranges:
Single pulse mode (0 Hz)

0.1 to 1.0 Hz in increments of 0.1 Hz
1 to 10 Hz in increments of 0.5 Hz
30 to 100 Hz in increments of 5 Hz (PowerMAG 100 only*)
*Remark: The device type can be identified on the type plate on the rear side of the device.
The pulse frequency can also be changed during the emission of a pulse sequence.
8.1.5. Pulse sequence duration

The maximum length of a pulse sequence to be emitted can also be selected with the
frequency/duration dial N. To do so, switch to the pulse sequence duration display mode (LED
indicator M: Sec) with the frequency/duration selector switch L. The selected value is shown
in the frequency/duration display O.
The pulse sequence duration can be selected in the following ranges:
1- 180 sec in increments of 1 sec

No limit on the pulse sequence duration (display "--")
If a maximum pulse sequence duration is selected, on actuation of the pulse button R a series
of pulses is emitted at the set frequency until either the selected pulse sequence duration is
reached or the pulse button has been released again.
The pulse sequence duration can also be changed during the emission of a pulse sequence.
8.1.6. Pulse release

If the pulse button R illuminates, then it is enabled. In single pulse mode (pulse frequency set
to 0 Hz) a single stimulation pulse is emitted with the selected pulse shape on actuation of the
button (or optionally with the yellow foot switch or the hand switch). In repeat mode - pulse
frequency 0.1-30 Hz (PowerMAG 30) or 0.1-100 Hz (PowerMAG 100) - a pulse sequence with
the set stimulation frequency is emitted as long as the button is pressed.
If a maximum pulse sequence duration is selected, on actuation of the pulse button R (or
optionally with the yellow foot switch or hand switch) a series of pulses is emitted at the set
frequency until either the selected pulse sequence duration is reached or the pulse button has
been released again.

Safety mechanism: The necessary pulse parameters (intensity and frequency)

are limited by the safety limits (E and F). If they are exceeded, the device
indicates this both visually and audibly.
Note
Safety mechanism: Before a pulse release is possible, the stimulation coil must
be enabled. This is done by actuating the foot switch.
Note
8.1.7. Saving and restoring the settings

By pressing the store button S, the currently set values for pulse intensity, pulse frequency,
pulse sequence duration and pulse shape are saved. By pressing the recall button T, the
previously saved values are restored.
The saved values are also retained when the stimulator is switched off. In doing so, it is then
possible to quickly and easily restore a previously saved set of standard settings after
switching on the device.
This function should be primarily of assistance during coil replacement. The

saved stimulation parameters should only be restored if the last session for a
test subject was no more than a half a day earlier. The motor threshold can vary
greatly from day to day – whereby values determined earlier would have an
Note undesired stimulation effect. In addition, these values should be checked on the
basis of a stimulation log before the pulse release.
8.1.8. Pulse polarity

The positive polarity LED U illuminates if the next pulse half wave will be emitted with positive
polarity. If full-wave is selected as the pulse shape, the indicator illuminates if the first half-
wave of the full-wave pulse will be emitted with positive polarity.
Should the pulse polarity be changed, a half-wave pulse must be released. The next pulse is
then emitted with the desired polarity. In order to avoid undesired stimulation effects, the
stimulation coil may be removed from the patient while this happens or a low pulse intensity
can be selected.
8.1.9. Coil temperature

The coil temperature indicator H shows the temperature of the plugged-in stimulation coil. If a
temperature of 41°C is exceeded, release of pulses is blocked until the coil has cooled down
again. The indicator for 40°C also flashes.
Pulse release is likewise blocked for safety reasons if the coil temperature is below 2°C. The
indicator for 18°C also flashes.
8.1.10. Precision indicator

The precision indicator K illuminates green if the device's internal stimulation voltage regulation
is capable of precisely attaining the set value.
If the stimulation voltage cannot be readjusted quickly enough, the precision indicator K
illuminates red. This may be the case, for example, if a pulse with an alternating higher and
lower intensity is emitted with a higher frequency.

8.1.11. Standby mode

If none of the stimulator controls are actuated for 5 minutes, it switches to standby mode. This
is indicated by the selected pulse intensity flashing in the pulse intensity display J. The
stimulator power circuit is switched off in the process.
Press any control on the front panel to bring the device out of standby mode. The stimulator is
then operational again and the pulse button R illuminates.
After standby mode, the first pulse is always positive.
Note
8.2. External control

The connections Trigger IN, Trigger OUT and Analogue Interface (X,
Y and Z) make low voltages accessible to the touch. For safety
reasons, do not touch these connections and the patient / test subject
at the same time.
Additional equipment which is connected to the analogue and digital

interfaces of the device must be proven to fulfil the corresponding IEC
specifications (e.g. IEC 60950 for data processing devices and IEC
60601-1 for electrical medical devices). In addition, all configurations
must comply with the currently valid version of the system standard
IEC 60601-1-1. Whoever connects additional devices to the signal
input or output parts is the system configurator and is, therefore,
responsible for adherence to the valid version of the system standard
IEC 60601-1-1.
Supply cables which are necessary for the connection of additional

equipment may not exceed 3m in length.
In most applications the rTMS will be used in combination with EMG devices or other external
devices. The rTMS provides the following control possibilities for this purpose:
External triggering: Pulse request via trigger input, status of the pulse release through trigger
output (e.g. for latency measurements)
Full external control: With suitable software, single pulses or pulse sequences can be
requested (pulses must be individually requested using the intensity and pulse shape
parameters); the coil temperature and the precision status are provided.
8.2.1. External triggering

With the trigger input (BNC connection socket X) the rTMS can be triggered by a signal from
an external device, which means the pulse trigger (pulse button R) is provided by an external
device. The remaining pulse parameters can be specified via the front panel (operating mode
switch B to Manual) or alternatively through the analogue interface Z (operating mode switch B
to Analog). The collars of the two BNC sockets (X and Y, Figure 8-1) are at earth potential
(protective earth conductor).

The trigger input and output (Trigger Input and Trigger Output) are always active.
Figure 8-1: BNC connections for the signals Trigger Input (left) and Trigger Output (right)
Trigger Input: Digital input for the pulse release - causes pulse release after
constant delay time of 1ms (edge-triggered to the rising edge; 5 V
TTL signal; positive polarity, input impedance 5 kOhm, minimum
pulse width 200 µs). Causes pulse release after constant delay
time (1 ms).
Trigger Output: Digital output for trigger signal - rising edge 100µs before the pulse
emission (5 V TTL signal; positive polarity, impedance 50 Ohm,
short-circuit-proof I(max)=100mA, pulse width: 4ms)
8.2.2. Full external control

The stimulator can be controlled with suitable external hardware through the analogue
interface connector Z. The analogue interface socket Z (Figure 8-2) and its allocation viewed
end-on (Figure 8-3) are depicted in the following:
Figure 8-2: Analogue interface on the rear side of the device
Figure 8-3: Allocation of the analogue interface (end-on view).

The GND connector pin is at earth potential (protective earth
conductor).

Inputs
Pulse shape Digital input (TTL signal, status-controlled; input impedance 5 kΩ) for selection
of the pulse shape
Low signal (0 V) Half-wave pulse
Low signal (5 V) Full-wave pulse
The signal must be present at least 1 ms before and 10 µs after

the trigger IN-edge.
Note
Pulse intensity Analogue input for selection of the pulse intensity

0-5V 0 - 100%
Target signal value must be present at least 20 ms before the trigger IN-edge.
Unnecessary jumps in intensity (e.g. from 80% -> 0% -> 90%)

should be avoided insofar as possible, because the device is
unnecessarily stressed by the charging and discharging
Note processes.
At frequencies >30 Hz the intensity is restricted by the device.

If too high of an intensity is requested, n.P. (not possible)
appears on the pulse intensity display J and the device
Note switches to standby mode.
Trigger Corresponds to the signal trigger input and is galvanically connected to it
Outputs
Polarity Digital output for polarity signal (TTL signal, status-controlled)
Low signal (0 V) Negative polarity
Negative full-wave Negative half-wave
High signal (5 V) Positive polarity
Positive full-wave Positive half-wave
Coil temperature Analogue output for coil temperature

Output signal proportional to the coil temperature, 100 mV/°C
Trigger Corresponds to the signal trigger output and is galvanically connected to it
The trigger input and output (Trigger Input and Trigger Output) are always active.

In addition, the coil temperature, precision control, as well as the pulse polarity are shown on
the front panel. Four horizontal lines are shown in the pulse intensity display J; during on-going
pulse sequence emission, a moving column signalises the activity. The pulse shape LEDs Q,
the frequency/duration display and indicators O and M and the pulse readiness indicator R are
inactive.
The controls on the front panel are likewise inactive.
If no pulse has been released for a period of five minutes and none of the controls on the front
panel has been actuated, the stimulator switches to standby mode. This is indicated by a
flashing pulse intensity display J. Press any of the controls to end standby mode. Then the
stimulator is operational again.

ERROR MESSAGES AND MEASURES IN CASE OF
FAULTS
9. Error messages and measures in case of faults
The following warning

and error messages can
be issued on the pulse
intensity display J:
Display J Meaning
Coil
High voltage is present at the stimulation socket C!
Do not touch! Switch off the device immediately!
Caution
No stimulation coil is plugged in. Switch off the device immediately.

Plug the stimulation coil into the socket C while the device is
switched off (see Commissioning). Only switch on the device again
when the coil is plugged in!
°C Device overheating → The stimulation coil has exceeded the limit
value of 41°C. The device is blocked from emitting pulses. It is
possible to connect a new coil (Caution! When replacing, first switch
off the device!) or wait until the coil has cooled down again (coil
temperature indicator H).
Err0 to Err9 Internal device error has occurred -> Switch off device and wait a
few minutes before re-starting. If the error message remains, the
device requires maintenance (Caution! Maintenance and repairs
may only be performed by the manufacturer!)
Fault Measures
Display and LEDs do After switching on the stimulator, the display and the LEDs on the
not illuminate front panel do not illuminate → Check the current supply and the
input-side fuses (cf. chapter 11.1 Replacing fuses)
Pulse emission not Release foot switch, switch device on and off and actuate foot
possible switch again. The foot switch must be pressed and held in order to
enable the release of stimulation pulses at the front panel and/or by
external interface (cf. chapter 3.5. Measures for maximum patient
safety, chapter 6.8. Switching on).

CLEANING AND CARE
10. Cleaning and care
10.1. Cleaning the device and the coil

Disconnect the device from the mains before cleaning (pull out the mains plug).
The device and the stimulation coils may be wiped off using a damp cloth (water). Before
using again, the device and the stimulation coils must be completely dry.
Diluted liquid household cleaner (no abrasives) or diluted alcohol can be used as a cleaning
agent. In the process, it must be ensured that no moisture penetrates into the device (only
moisten the cloth insofar as necessary). Cleaning agent must not be allowed to penetrate into
the device! Should liquid penetrate into the device, it may only be operated after maintenance
has been performed by the manufacturer.
The stimulation coils cannot be sterilised. If you use the coils in a sterile room or want to avoid
direct contact with the coil, you can cover it in a sterile sleeve (e.g. a sterile plastic bag).
10.2. Disinfecting the device

It is advantageous to disinfect the coil(s), the device and its accessories using a soft cloth
moistened with ethyl alcohol, propyl alcohol or isopropyl alcohol.
A 1% solution of the disinfectant "Gigasept Instru AF" should be used to disinfect the device.

MAINTENANCE
11. Maintenance
11.1. Replacing fuses

To replace fuses:
• Switch off the device (V)
• Pull out the mains cable (W)
• Unlock the fuse compartment (aa): To do so, first release one catch using a small
slotted screwdriver, then the other by pressing gently. The fuse compartment can then
be easily pulled out.
• Replace fuses (2 x 6.3 A T according to IEC 127)
• Insert the fuse compartment (aa) straight and press gently until it locks into place
• Plug in the mains cable (W)
11.2. Maintenance instructions / recurring safety checks according to

the German medical device operator ordinance (MPBetreibV) § 6
In the interest of safety for patients and operating personnel, regular maintenance must be
performed in two-year intervals after commissioning.
During this, the inspection of the safety of the device has the highest priority. The
measurements taken should be compared with the initial measurements in order to be able to
recognise significant changes that indicate errors.
Inspection and repair must be performed by authorised, expert personnel, which means by the
manufacturer or a customer service agent authorised by MAG & More GmbH, e.g. our factory
representatives. We recommend the signing of a maintenance contract.
The "Ordinance on the installation, operation and use of medical devices (German Medical
Device Operator Ordinance [MPBetreibV])" must be observed for magnetic stimulators. The
operator must also keep a medical device log. The medical device log as well as the operating
manual should be stored so that the necessary information for use of the medical device is
accessible to the user during usage.
During maintenance and after any repair, the safety checks according to § 6 of the German
medical device operator ordinance (MPBetreibV) are necessary. Inspections must be
performed and, if necessary, cleaning, correction or repairs must be initiated.
The following must be inspected during the safety checks:
• Visual inspection of the device, coil(s) and supply cables (mechanical integrity,
legibility of all labelling and markings which are important for functionality,
accessories complete, availability of operating manual)
• Check for presence of the operating manual and the correct serial number.
• Correctness of the values of the externally accessible fuses: 2 x T 6.3 A (IEC 127)
• Mains switch function check
• Inspection of the device indicators and displays
• Setting of the pulse voltages in the increments 25% / 50% / 100%. As part of this
process, trigger a pulse emission (full-wave mode) for each pulse voltage. The
pulse emission must be audible; the volume increases as the intensity increases.
• Function check of the foot switch

MAINTENANCE
• Pulse release at 100% intensity

• Test of the monitoring system for maximum pulse intensity / pulse frequency
• Test of the excess temperature shut-off
• Test for recognition of whether a coil is plugged in or not (no coil identification)
• Protective earth conductor resistance (with mains cable) according to DIN VDE
0751-1:2001: measurement between earth contact on the mains plug and the
potential equalisation pin (never at one of the BNC sockets). The highest
permissible value (together with the removable mains connection cable): 0.3 Ohm.
• Equivalent device leakage current according to DIN VDE 0751-1:2001. Highest
permissible value: 1mA
• Equivalent patient leakage current according to DIN VDE 0751-1:2001;
measurement takes place with mains voltage present at the application part. For the
measurement of the equivalent patient leakage current, the housing of the coil is to
be wrapped in metal foil (household aluminium foil). Highest permissible value: 5mA
(Type BF)
11.3. Repairs
Repairs may only be performed by a customer service agent authorised by MAG & More
GmbH, e.g. our factory representatives or by our central service division in Munich.
Even replacement of the mains connection cable counts as a repair in the above sense (they
significantly influence the resistance of the protective earth conductor). The repair technician
must provide a certificate (as proof for the supervising authorities) indicating the type and
scope of the repair, which also provides the date of performance and company name along
with a signature.
After repairs, minimum inspections include:

• Equivalent device leakage current according to VDE 0751 Part 1
• Equivalent patient leakage currents according to VDE 0751 Part 1
• Protective earth conductor resistance according to VDE 0751 Part 1
• Device function
11.4. Enhancements and modifications

In the case of enhancements and modifications to hardware and software which have been
performed without our written approval and without altering the device-specific declaration of
conformity, any warranty becomes null and void (see Directive 93/42/EEC).
The manufacturer is only liable for the safety, reliability and performance of the equipment if:
• additional equipment which is connected to the analogue and digital interfaces of the
device is proven to fulfil the corresponding EN specifications (e.g. IEC 60950 for data
processing devices and EN 60601 for electrical medical devices)! In addition, it must be
ensured that all configurations satisfy the system standard EN 60601-1-1. Whoever
connects additional equipment to the signal input or output part is the system
configurator and is, therefore, responsible for ensuring that the system standard EN
60601-1-1 is adhered to! (In case of enquiries, please contact your local dealer or the
technical service department),
• supply cables which are necessary for connecting additional equipment exceed 3m in
length,
• all enhancements, settings, changes are performed by persons authorised for this
purpose,

MAINTENANCE
• the electrical installation of the room in question conforms to the requirements of DIN
VDE 0100-710:2002 or IEC 60364-7-710:2002,
• and the device is used in accordance with the operating manual.

ENVIRONMENTAL PROTECTION
12. Environmental protection

The main requirements for environmental protection were already taken into consideration
during the development of the rTMS:
– Avoid emissions and save resources –
A long service life and easily performed repairs are visible signs of this.
With the replacement and the repair of assemblies, MAG & More GmbH ensures that high-
quality mechanical and electronic parts are used for as long as possible and are then recycled
or disposed of in an environmentally-friendly manner.
12.1. Emissions or waste materials

During operation of the rTMS, no harmful emissions or waste materials arise.
12.2. Disposal
Old devices: Classification: Electronic scrap
MAG & More GmbH accepts old devices for disposal at the
customer's request. Where it is reasonable to do so, individual
assemblies are repaired and re-used as replacement parts. The
remaining parts are separated by material type and sent to
recognised waste disposal companies.
Accessories: Classification: Electronic scrap

Cables, foot switches, Wherever possible, these parts are repaired by the MAG & More
stimulation coils customer service department. Disposal follows the same course
as for old devices.
Packing material Classification: Waste for recycling

Packing material is accepted by MAG & More and/or the
supplying factory representative on request and, where it is
reasonable to do so, reused or separated by material type and
sent to a recognised waste disposal company.

ACCESSORIES
13. Accessories
Accessory items supplied with
Order no. Item the device as standard
510519 Double coil yes

635424 Pneumatic foot switch yes
886036 Mains cable 3x1.0 qmm, length 3.0 m yes
629540 TMS coil supporting arm yes

rTMS trolley with coil supporting arm and drawer
630227 yes
compartment
510522 Circular coil no
510523 Precision coil no

Optional pulse trigger –
635430 no
electric foot switch with protective hood
Optional pulse trigger –
635440 no
electric hand switch

SPECIFICATIONS
14. Specifications
14.1. rTMS
Power circuit
Pulse shape (time spent by Sine half-wave or sine full-wave
the coil current in the
stimulation coil)
Pulse energy (energy content Minimum value: 0 Ws

of the internal device memory
Maximum value: 160 Ws
which is available for a
stimulus)
Pulse duration Half-wave: approx. 80 µs *
Full-wave: approx. 160 µs *
*in combination with the double coil, item no. 510519m
Stimulation frequency Maximum 30 Hz (device type PowerMAG 30,
PowerMAG 3 research)
Maximum 100 Hz (device type PowerMAG 100,
PowerMAG 100 research)
Stimulation coil (double coil type)
Magnetic field: approx. 1 Tesla maximum
Dimensions: 2 x 90 mm diameter
Safety criteria
Safety standards EN 60601-1:2006
IEC 60601-1:2006
Medical electrical equipment, Part 1: General
requirements for basic safety and essential
performance
Protection class I
Device type BF (see chapter Symbols)
Classification
Type of protection against Protection class I: All accessible, electrically conductive
electric shock parts are connected to the protective earth conductor.
Degree of protection against The device is of the type BF (Body Floating) and
electric shock thereby offers sufficient protection against electric
shock in regard to permissible leakage currents and
based on the reliability of the protective earth conductor
connection. The device is designed with an electrically
insulated (floating) application part.
Degree of protection against IP 20: Classification as a "normal device" (closed

harmful penetration of water device without protection against the penetration of
water)

SPECIFICATIONS
Degree of protection during The device is not permitted for this.

operation in the presence of
potentially explosive mixtures
of anaesthetics with air or
oxygen or with nitrous oxide
Permissible operating mode In principle, the device is suitable for continuous

operation. However, intermittent operation can arise
due to overheating coils (cf. chapter 6.9).
Permissible sterilisation or see chapter 9

disinfection processes
Type of electromagnetic Class B, Group 1 (EMC table chapter 14.6.)
compatibility
Marking
14.2. General specifications
Supply voltage Refer to rating plate on the rear panel
Fuses 2 x 6.3 A T according to IEC 127
Power consumption 50 VA in standby mode

800 VA permissible continuous consumption
1800 VA maximum (intermittent operation)
Current consumption 7.8 A at rated voltage

Intermittent operation at full output (maximum output values):
120 sec, following 8 min bar on operation
Dimensions approx. 49 cm x 24 cm x 57 cm (W x H x D)
Weight approx. 38 kg
Ambient conditions Operation (in use):
Ambient temperature: 10°C to 40°C;
Recommendation: The ambient temperature should not
exceed 25°C in order to ensure a sufficient treatment duration
(coil heating)
Relative humidity: 30-75%, no dew,
Air pressure: 700hPa to 1200hPa
Storage: Ambient temperature: 0°C to 60°C; relative humidity:
30-75 %
Transport: Ambient temperature: -20°C to 60°C; relative
humidity: 30-75 %, air pressure 700hPa to 1200hPa
UMDNS code: Stimulators, Electromagnetic: 12-415

SPECIFICATIONS
14.3. Plug connector and socket allocations
Additional equipment which is connected to the analogue and digital

interfaces of the device must be proven to fulfil the corresponding IEC
specifications (e.g. IEC 60950 for data processing devices and IEC
60601-1 for electrical medical devices). In addition, all configurations
must comply with the currently valid version of the system standard
IEC 60601-1-1. Whoever connects additional devices to the signal
input or output parts is the system configurator and is, therefore,
responsible for adherence to the valid version of the system standard
IEC 60601-1-1.
Supply cables which are necessary for the connection of additional

equipment may not exceed 3m in length.
14.3.1. Mains connection socket
Figure 14-1: Mains connection socket, fuse holder and ON/OFF switch on the rear side of the device
The supplied mains cable is used to connect the device to the mains. The associated mains
connection socket is located on the rear side of the device.
Before commissioning, it must be ensured that the mains voltage

is according to the rating plate and that the outlet for connection of
the device is fused for a current of 16 A.
As a basic rule, operation is only permitted using outlets with an
Commissioning earth contact. Extension cords may not be used.
14.3.2. Coil socket
• There is a risk of electric shock at the free, unoccupied coil

socket (Fig. 14-2)! Do not touch!
• The device may only be operated with a coil plugged in!
• The coil may not be unplugged or replaced while the device
High voltage
at the coil socket is switched on!

SPECIFICATIONS
Figure 14-2: Coil socket (right) and connection socket for the pneumatic foot switch (left) on the front
panel of the device
The coil socket for the stimulation coil is located on the front panel of the device. In order to
ensure that the plug connector cannot loosen from the socket, it must be secured with the
silver coupling nut (cf. chapter 6.6.2).
14.3.3. Analogue interface socket
Figure 14-3: Analogue interface on the rear side of the device
The analogue interface socket is provided for the connection of an external control device. This
connection socket is identified in the operating manual (chapter 7 and 8) with the letter "Z". A
precise description of the signal allocation can be found in chapter 8.2.
14.3.4. Digital input
Figure 14-4: BNC connections for the signals Trigger Input (left) and Trigger Output (right)
Trigger Input: Digital input for the pulse release - causes pulse release after
constant delay time of 1ms (edge-triggered to the rising edge; 5 V
TTL signal; positive polarity, input impedance 5 kOhm, minimum
pulse width 200 µs). Causes pulse release after constant delay
time (1 ms).

SPECIFICATIONS
The trigger input BNC connection on the rear side of the rTMS is provided for the triggering of
the rTMS by an external device. This connection socket is identified in the operating manual
(chapter 7 and 8) with the letter "X".
14.3.5. Digital output

Trigger Output: Digital output for trigger signal - rising edge 100µs before the pulse
emission (5 V TTL signal; positive polarity, impedance 50 Ohm,
short-circuit-proof I(max)=100mA, pulse width: 4ms)
The trigger output BNC connection on the rear side of the rTMS is provided for the triggering of
an external device by the rTMS. This connector is identified in the operating manual (chapter 7
and 8) with the letter "Y".
14.3.6. Potential equalisation
Figure 14-5: Potential equalisation pin with symbol
Potential equalisation pin:
Potential equalisation pin for potential equalisation between

various devices. This connector is identified in the operating
manual (chapter 7 and 8) with the letters "ab".
14.3.7. Synchronisation output
Figure 14-6: Synchronization Output with covering cap (only available with the PowerMAG research)
Synchronization Output, 4 MHz, synchron to the internal clock of the rTMS (5 V TTL
signal; positive polarity, impedance 50 Ohm, I(max)=10mA, 4MHz). This connector is
identified in the operating manual (chapter 7 and 8) with the letters "ad".

SPECIFICATIONS
14.3.8. Connection socket for optional pulse trigger
The optional pulse trigger (available in a hand or foot switch variant) is connected to the
connection socket ac on the front panel. Its connector is locked in place by means of a screw
closure.
Hand switch Foot switch with protective hood

SPECIFICATIONS
14.4. Information regarding the electromagnetic compatibility of the

rTMS
14.4.1. Guidelines and manufacturer's declaration – electromagnetic
emissions
The rTMS is intended for operation in a similar environment to that indicated below. The
customer or the user of the rTMS should ensure that it is operated in such an environment.
Transient emission
Conformity Electromagnetic environment – guidelines
measurements
The rTMS only uses HF energy for its
internal function. Therefore, its HF
emission is very low and it is improbable
that nearby electronic devices will be
disturbed.
HF emissions according to
Group 1
CISPR 11
Caution! This does not apply for the strong
magnetic fields generated from the
treatment coil during the pulse emission! In
this regard, observe the warning notes in
chapter 3 without fail!
HF emissions according to
Class B
CISPR 11
Harmonic emissions according
Class B
to IEC 61000-3-2
Emissions of voltage
fluctuations/flicker according to Conforms
IEC 61000-3-3
HF emissions Conforms
according to CISPR 14-1

SPECIFICATIONS
14.4.2. Guidelines and manufacturer's declaration – electromagnetic immunity

The rTMS is intended for operation in an electromagnetic environment similar to that indicated
below. The customer or the user of the rTMS should ensure that it is operated in such an
environment.
IEC 60601- Testing Electromagnetic environment

Immunity tests Conformity level
level – guidelines
Floors should consist of wood
± 6 kV contact or concrete or be covered in
Electrostatic discharge
discharge ceramic tile. If the floor is
(ESD) according to Fulfilled
covered with a synthetic
IEC 61000-4-2
± 8 kV air discharge material, the relative humidity
must be at least 30%.
± 2 kV for mains
Fast transient electric The quality of the supply
cables
disturbances/bursts voltage should correspond to
Fulfilled
according to that of a typical commercial
± 1 kV for input and
IEC 61000-4-4 and hospital environment.
output cables
± 1 kV series mode
The quality of the supply
Surge voltage (surges) voltage
voltage should correspond to
according to Fulfilled
that of a typical commercial
IEC 61000-4-5 ± 2 kV common
and hospital environment.
mode voltage
< 5% UT
(>95% dip of UT )
for ½ period
The quality of the supply
voltage should correspond to
40% UT
that of a typical commercial
Voltage dips, brief (60% dip of UT )
and hospital environment. If
interruptions and for 5 periods
the rTMS is required to
fluctuations of the supply Fulfilled
continue working even if the
voltage according to 70% UT
power supply is interrupted,
IEC 61000-4-11 (30% dip of UT )
supplying the rTMS from an
for 25 periods
uninterruptible power supply
or battery is recommended.
< 5% UT
(>95% dip of UT )
for 5 seconds
Magnetic fields at the mains
Magnetic field at the supply frequency should correspond
frequency (50/60 Hz) 3 A/m Fulfilled to the typical values found in
according to IEC 61000-4-8 the commercial and hospital
environment.
REMARK UT is the mains alternating current before the application of the testing level.

SPECIFICATIONS
14.4.3. Guidelines and manufacturer's declaration – electromagnetic immunity

The rTMS is intended for operation in an electromagnetic environment similar to that indicated
below. The customer or the user of the rTMS should ensure that it is operated in such an
environment.
IEC 60601- Conformity Electromagnetic environment –

Immunity tests
Testing level level guidelines
Portable and mobile radio devices
should not be used at a closer distance
to the rTMS, including its cables, than
the recommended safety distance,
which is calculated according to the
applicable equation for the transmission
frequency.
Recommended safety distance:

3,5
d =[ ] P
3
3,5
d =[ ] P
3 for 80 MHz to 800 MHz
Conducted HF 7
d =[ ] P
disturbances 3
3 Veff for 800 MHz to 2.5 GHz
according to IEC 61000- 3 V/m
150 kHz to 80
4-6
MHz where P represents the rated output of
the transmitter in watts (W) according to
the information from the transmitter
Radiated
3 Veff manufacturer, and d represents the
HF disturbances 3 V/m
80 MHz to 2.5 recommended safety distance in metres
according to IEC 61000-
GHz (m).
4-3
According to an investigation on
a
location , the field strength of stationary
radio transmitters should be less than
b
the conformity level.
Disruptions are possible in the vicinity of

devices which have the following
symbol.
Remark 1: At 80 MHz and 800 MHz the higher frequency range applies.
Remark 2: These guidelines may not be applicable in all cases. The spread of electromagnetic
disturbances is influenced by absorptions and reflections of buildings, objects and
people.

SPECIFICATIONS
a
) The field strength of stationary transmitters, such as base stations of cordless telephones and
mobile handheld radios, amateur radio stations, AM and FM radio and television broadcasters can, in
theory, not be precisely determined in advance. In order to determine the electromagnetic
environment in regard to the stationary transmitter, a study of the location should be considered. If
the measured field strength at the location in which the rTMS is used exceeds the upper conformity
limit, the rTMS should be observed in order to verify it is working properly. If unusual characteristics
are observed, additional measures may be necessary, such as a change in positioning or location of
the rTMS.
b
) Above the frequency range of 150 kHz to 80 MHz, the field strength should be less than [V1] V/m.
14.4.4. Recommended safety distances between portable and mobile HF

telecommunications devices and the rTMS
The rTMS is intended for operation in an electromagnetic environment in which the HF

disturbances are controlled. The customer or the user of the rTMS can assist by avoiding
electromagnetic disturbances through observance of the minimum distance between portable
and mobile HF telecommunications devices (transmitters) and the rTMS - depending on the
output power of the communication device, as indicated below.
Safety distance depending on the transmitter frequency

d [m]
Rated output of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter
P [W]
0,01 0,3 0,3 0,5

0,1 0,5 0,5 0,8
1 1,2 1,2 2,5
10 4 4 8
100 12 12 24
For transmitters whose maximum rated output is not indicated in the table above, the recommended
safety distance d in metres (m) can be determined using the equation in the respective column,
whereby P is the maximum rated output of the transmitter in watts (W) according to the information
from the manufacturer of the transmitter.
Remark 1: At 80 MHz and 800 MHz the higher frequency range applies.
Remark 2: These guidelines may not be applicable in all cases. The spread of electromagnetic
disturbances is influenced by absorptions and reflections of buildings, objects and
people.

CERTIFICATION
15. Certification
Heitec AG is certified according to:
• DIN EN ISO 13485:2003

• Directive 93/42/EEC, Annex II.
Notified body:
• LGA InterCert GmbH, notified body No. 1275.
Device of the equipment range rTMS:

• CE marking according to Directive 93/42/EEC, Annex II.
The rTMS is only permitted for operation with the accessories listed in section 13 according to
Directive 93/42/EEC.
rTMS devices fulfil the requirements of the harmonised standards:
• EN 60601-1:2006
Medizinische elektrische Geräte, Teil 1: Allgemeine Festlegungen für die Sicherheit
IEC 60601-1:2006
Medical electrical equipment, Part 1: General requirements for basic safety and essential
performance
• EN 60601-1-2:2007
Medizinische elektrische Geräte, Teil 1-2: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale – Ergänzungsnorm: Elektromagnetische
Verträglichkeit – Anforderungen und Prüfungen
IEC 60601-1-2:2007
Medical electrical equipment, Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• EN 60601-1-4:1996 +A1:1999
Medizinische elektrische Geräte, Teil 1-4: Allgemeine Festlegungen für die Sicherheit -
Ergänzungsnorm: Programmierbare elektrische medizinische Systeme
IEC 60601-1-4:1996 +A1:1999
Medical electrical equipment, Part 1-4: General requirements for safety - Collateral Standard:
Programmable electrical medical systems
• EN 60601-1-6:2006
Medizinische elektrische Geräte, Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale – Ergänzungsnorm: Gebrauchstauglichkeit
IEC 60601-1-6:2006
Medical electrical equipment, Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
• EN 62304:2006
Medizingeräte-Software, Software-Lebenszyklus-Prozesse
IEC 62304:2006
Medical device software, Software life cycle processes
• EN ISO 14971:2009
Medizinprodukte, Anwendung des Risikomanagements auf Medizinprodukte
EN ISO 14971:2009

CERTIFICATION
Medical devices - Application of risk management to medical devices
• EN 980:2008
Symbole zur Kennzeichnung von Medizinprodukten
EN 980:2008
Symbols for use in the labeling of medical devices
• EN 1041:2008
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
EN 1041:2008
Information supplied by the manufacturer of medical devices

APPENDIX
Appendix
Wassermann Guidelines - Safety guidelines
Eric M. Wassermann: Risk and safety of repetitive transcranial magnetic stimulation: report and
suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial
Magnetic Stimulation, June 5–7, 1996
Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, Building 10,
Room 5N226, National Institutes of Health, 10 Center Drive, MSC-1428, Bethesda, MD 20892–
1428, USA
Table 1: Number of safe pulses depending on the frequency in Hz and the pulse intensity in %
of the MEP threshold.

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OPERATING MANUAL

Sales and service

Release: February 2010

Tel. +49 (0)9131 877-0

This operating manual is protected by copyright. All rights reserved.

This operating manual pertains to the medical

rTMS February 2010 Page 1

Page 2 February 2010 rTMS

rTMS February 2010 Page 3

(Example type plate):

MPG classification Class IIa

MP BetreibV classification MP BetreibV Annex 1

Electrical protection class Protection class 1 (Protection type BF)

Device designation: Magnetic field therapy device

UMDNS code: 12-415

rTMS February 2010 Page 5

Device usage: Diagnostic and therapeutic device

Application area: Clinical and scientific studies and applications in the

Users: Medically trained personnel, medical engineers, doctors

Contraindications: See chapter 3.2. "Contraindications"

Page 6 February 2010 rTMS

3. Warnings and safety instructions

3.1. The basics

rTMS February 2010 Page 7

The following safety instructions must be observed, in particular:

• Danger to life! The stimulation coil must be carefully

• There is a risk of electric shock at the free, unoccupied

Figure 3-1: Coil socket on the front panel of the rTMS

• Danger to life! The device may only be opened by the

Page 8 February 2010 rTMS

3.2. Contraindications of use

• The rTMS may not be used near external equipment with a

• Direct use on the heart is not permitted.

Use on the heart

The use of the rTMS is prohibited for patients or test subjects

3.3. Residual risks and safety guidelines

Wassermann: Risk and Safety of repetitive transcranial magnetic stimulation: report

• TMS laboratories must be equipped with a couch!

rTMS February 2010 Page 9

• Individually adjust safety limits before each treatment!

3.4. Safe operation of the rTMS

• The classification and recognition of the correct

Page 10 February 2010 rTMS

The minimum distance of magnetically-sensitive objects (watches,

During operation of the coil, a safety distance of 30 cm to the

Before commissioning, it must be ensured that the mains voltage

• Before any type of cleaning, maintenance or terminal assignment (replacing the

• damage to the device is visually recognisable,

rTMS February 2010 Page 11

3.5. Measures for maximum patient safety

3.6. Safety note for the trolley

Positioning on an inclined surface is discouraged. If the trolley must be positioned on an

Page 12 February 2010 rTMS

3.7. Liability of the manufacturer

• Assembly, enhancements, modifications or repairs may only be performed by persons

rTMS February 2010 Page 13

4. Description of the system

4.1. Physical operating method

4.2. Motor threshold

Page 14 February 2010 rTMS