MagPro Family User Guide sw ver V7.1 Oct 2015

Copyright © 2015 Tonica Elektronik A/S. All rights reserved. The contents of this manual are the property of Tonica Elektronik A/S. Any reproduction in whole or in part is strictly prohibited. At the time of printing this manual correctly described the device and its functions. However, as modifications may have been carried out since the production of this manual, the system package may contain one or more addenda to the manual. This manual including any such addenda must be thoroughly read, before using the device. The following situations void any guarantee(s) and obligations for Tonica Elektronik A/S: - The device is not used according to the enclosed manuals and other accompanying documentation - The device is installed or modified by persons other than Tonica Elektronik A/S or other authorized service technicians.

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Table of Contents Safety Information ...5 Intended use ... 6 Operator ... 6 Contraindications ... 6 Precautions ... 7 Warnings and Cautions ... 7 Safety Checks ... 10 Patient Safety ... 11 Safety Guideline ... 12 IEC 60601-1 Medical Electrical Equipment... 14 IEC 60601-1 Classification Requirements ... 15

What is Magnetic Stimulation? ... 16 Application possibilities ... 16

Motor Threshold (MT) determination ... 17 Presentation ... 18 Working Modes ... 18 Current Direction ... 18 Waveforms ... 18 Repetition Rate... 18 Features ... 19

Symbols and Connections ... 20 Rear Panel ... 20

Controls ... 21 Front Panel ... 21 Coils ... 22

Software Controls ... 23 Status Area (1) ... 23 Information Area (2) ... 24 Selection Area (3) ... 24 Soft Key Area (4)... 24

Getting Started ... 25 General Workflow ... 25 Main Menu ... 25 Timing Menu ... 29 Biphasic Burst (Theta Burst) stimulation ... 31 Protocol Tool ... 33 Data Transfer ... 33 Configuration Menu ... 34 Trigger Menu ... 35 Service Menu ... 36

Accessories ... 38 Magnetic Stimulation Coils ... 38

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Selection Criteria for Magnetic Stimulating Coils ... 38 Magnetic Stimulation Accessories Catalogue ... 38 Trolley... 39 MEP Monitor ... 39

Menu tree... 40 MagPro R30 ... 40 MagPro R30 incl. MagOption ... 41 MagPro X100... 42 MagPro X100 incl. MagOption ... 43

Setting the Scale ... 44 MagPro R30 ... 44 MagPro R30 incl. MagOption ... 44 MagPro X100... 45 MagPro X100 incl. MagOption ... 45

Technical Data ... 46 Electromagnetic Data ... 46 Mechanical Data ... 46 Environmental Data ... 46 Power Supply ... 46 Options ... 46 Connections ... 47 Performance Data – Amplitude Roll-Off... 48 Error messages ... 49

Technical Description ... 50 Maintenance ... 53 Cleaning and Disinfecting Procedures ... 53 Waste Management ... 53

Electromagnetic Compatibility ... 54 Electromagnetic Emissions ... 54 Electromagnetic Immunity ... 55

Index ... 58

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Safety Information

Safety Information This section contains information on safety, intended use, contraindications, general warnings, cautions, daily safety checks and patient safety. Please also find extract of IEC 60601-1 Medical Electrical Equipment and Classification requirements. This device has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment. The present manual contains some information and warnings, which will have to be followed by the user to ensure safe operation and to retain the device in safe condition. This device has been designed for indoor use at room temperatures between +10°C and +30°C (+50°F to +86°F).

equipment to this device, please pay attention to the requirements of IEC 60601-1, Safety Requirements for medical electrical systems. Please find an extract of IEC 60601-1 later in this section.

 When the device is connected to its

mains supply, connectors may be live, and any opening of covers or removal of parts possible only with the aid of a tool is likely to expose live parts.

 Service must be referred to Tonica or

other authorized service personnel, except for such works described in this manual as being performed by the operator. The device must be disconnected from all voltage sources before being opened for any adjustment, replacement, maintenance or repair.

The mains plug must only be inserted in an appropriate mains socket outlet provided with a protective earth contact. It is forbidden to use extension cords.

 Where more than one piece of

WARNING Any interruption to the protective earth conductor inside or outside the device or disconnection of the protective earth connector terminal is likely to make the device dangerous. Intentional interruption is prohibited. The protective earth (ground) conductor should be checked regularly.

 Whenever it is likely that the protection

equipment is connected to a patient, attention must be paid to the summation of patient leakage currents.

When the device is producing maximum output, power consumption is very high – up to 2300 VA. To prevent any equipment nearby from malfunctioning, the device must be supplied from a separate wall outlet. This is especially important if the total installed power is low. If a problem arises it is usually recommended to seek the advice of a local electrician on this matter. Make sure you use the correct power cord, supplied with the device. For the combination of this device with other devices and / or for its connection to installations, the following applies:

 When connecting medical equipment

being supplied from an outlet located in a non-medically used room, or when connecting non-medical electrical

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has been impaired, the device must be disconnected and be secured against any unintended operation.

 The protection is likely to be impaired if, for example, the device:

- Shows visible damage. - Fails to perform the intended function. - Has been subjected to severe transport stresses. - Has insufficient earth connection. - Has been subjected to moisture.

 In that case, call qualified service

personnel to conduct at least a functional test and additionally a safety check including 1) an insulation test, 2) a ground continuity test and 3) a leakage current test, according to IEC 60601-1.

Safety Information

Intended use

Contraindications

Diagnostic Use The MagPro is intended as an electrophysiological aid to assess diagnosis and to monitor diseases of the central and peripheral nervous system, based on the use of Motor Evoked Potentials (MEP).

Implanted Electronic Devices and/or Conductive Objects near the coil

 Patients who have an implanted device

Therapeutic Use Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from two prior antidepressant medications, at or above the minimal effective dose and duration in the current episode. For further description of this intended use see User Guide “Depression Treatment with rTMS”.

that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter-defibrillators [ICD’s], vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD’s], ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed. Contraindicated use could result in serious injury or death. Contraindicated use could result in serious injury or death.

Non-Removable Metallic Objects near the coil

Operator Magnetic stimulation is a non-invasive technique to be used under constant supervision by qualified medical personal e.g. MD, PhD, neurophysiologists, psychiatrist, nurses and medical assistants, only on patients who are not anaesthetized and only for short term use. For the therapeutic use, the treatment must be performed by or under the supervision of a licensed psychiatrist, introduced to the use of the MagVenture system and who have carefully read and understood the User Guide before performing any treatment

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 Patients who have conductive,

ferromagnetic or other magneticsensitive metals implanted in their head or within 30 cm of the treatment coil (examples: cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments). Failure to follow this restriction could result in serious injury or death. NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients

Safety Information

Precautions

7.

Safety and effectiveness of magnetic stimulation could not be established in special patient populations, examples below:

 Patients with a history of epilepsy or unexplained seizures.

 Patients medicated with drugs lowering the seizure threshold (examples: neuroleptic agents and tricyclic antidepressants).

 Patients suffering from vascular,

traumatic, tumoral, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication.

 Patients with history of strokes, head injury or severe headaches.

 Patient suffering from sleep deprivation

Do you have metal in the brain, skull or elsewhere in your body (e.g., splinters, fragments, clips, etc.)? If so, specify the type of metal. 8. Do you have an implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)? 9. Do you have a cardiac pacemaker or intracardiac lines? 10. Do you have a medication infusion device? 11. Are you taking any medications? (please list) 12. Did you ever undergo TMS in the past? If so, were there any problems. 13. Did you ever undergo MRI in the past? If so, were there any problems. Affirmative answers to one or more of questions 1–13 do not represent absolute contraindications to TMS, but the risk/benefit ratio should be carefully balanced by the operator.

or alcoholism.

 Pregnant or nursing patients.  Patients with severe or recent cardiac

Warnings and Cautions See the accompanying documentation and carefully read the following warnings and cautions

disease.

 Comprehensive screening should

Warnings

include EEG before applying 50Hz and higher frequency rTMS to any patients suspect for paroxysmal EEG activity.

 Do not use this equipment for anything else than it is intended for by the manufacturer.

To identify if the patient suffer from one or more of the above listed contraindications and precautions a standard questionnaire is recommended. See an example below: 1. 2. 3.

4. 5. 6.

 The MagPro must only be used under

the constant supervision of qualified medical personal, only on patients who are not anaesthetized and only for short term use.

Do you have epilepsy or have you ever had a convulsion or a seizure? Have you ever had a fainting spell or syncope? If yes, please describe on which occasion(s)? Have you ever had a head trauma that was diagnosed as a concussion or was associated with loss of consciousness? Do you have any hearing problems or ringing in your ears? Do you have cochlear implants? Are you pregnant or is there any chance that you might be?

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 Patients undergoing rTMS should be observed closely for clinical worsening and in absolutely worst case seizure.

 To avoid risk of electric shock, this

equipment must only be connected to a supply mains with protective earth.

Safety Information

 Any interruption to the protective earth

conductor inside or outside the device or disconnection of the protective earth connector terminal is likely to make the device dangerous. Intentional interruption is prohibited. The protective earth (ground) conductor should be checked regularly.

 Do not perform single-pulse or pairedpulse TMS on children younger than 2 years.

 Do not perform rTMS on patients younger than 18 years.

 The device is not compatible for use in

 Keep out of reach of children.  Precautions should be taken when

 Rapid cortical stimulation can induce

 Do not use the equipment on patients

an MR magnetic field. Please consult the manufacturer for available special solutions.

seizures. Ensure that appropriate safety measures are taken, before using the equipment. See patient safety later in this section.

 To protect patients from excessive

exposure to magnetic gradients keep the number of stimulations as low as possible.

 Do NOT use the equipment when other equipment/device is within a distance of 1m from the connected coil.

 Never touch the metal pads in the large orange connector.

 Do not touch the small trigger

connector on the front panel and the coil cable while touching the patient.

 Do not touch the trigger connector or

COM port connectors on the rear panel while touching the patient.

 The device is not intended for use with

anesthetic gases or any other flammable media – danger of electrical ignition.

 The operator must be protected against long-term magnetic fields (e.g. by using a holding device as the Flexible Arm).

stimulating patients with suspected or diagnosed labile or hypertensive blood pressure. who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverterdefibrillators [ICD’s], vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD’s], ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed. Contraindicated use could result in serious injury or death.

 Do not use the equipment on patients

who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (examples: cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments). Failure to follow this restriction could result in serious injury or death. NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients

 Bystanders with implanted device of

any kind or implanted metallic objects MUST stay in distance of least 1m from the coil in operation.

 To minimize uncertainty it is important

 Hearing protection is recommended if

the coil is used near the head or when operating with more than 100 stimuli a day.

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always keeping the coil in direct contact and as tangent to the scalp surface, direct over the actual wanted exposed area.

Safety Information

 Electrical equipment for medical use

requires special EMC precautions and needs to be installed and serviced according to the EMC documentation of the device.

 If high speed stimulation protocols are

performed some increased temperature on the coil surface against the patient’s skin can occur. According to the IEC 60601-1:2005 standard a maximum temperature of 48°C is allowed for a time up to 10 minutes.

 Remove the coil from the patient when it is not used.

 Longer term effects of exposure to the

MagPro magnetic field on the head are not known. Experimental and observational evidence indicates that exposure to the type of magnetic fields produced by the MagPro coil does not present any significant risk of acute or long-term adverse effects. Ref.: the guideline “Safety of TMS Consensus Group, Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research” by Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Clin Neuro-physiology. 2009 Dec;120(12):2008-39.

 Disable the device when it is not being

Cautions

used by pressing the Enable/Disable button.

 Before connecting, please read this user guide.

 Before changing the stimulation coil,

 When connecting, attention must be

press Disable to avoid damage on personnel and equipment.

paid to IEC 60601-1. See page 14.

 Metallic (conductive) objects in the field may be propelled forcibly by the stimulus pulse. Make sure there are no rings, coins or similar metal objects near the coil when it is activated.

 Do not place the stimulation coil on or near: video monitors, watches, calculators, credit cards or computer disks. Damage or erasure may occur.

 Always use the Flexible Arm to hold the Magnetic Stimulation Coils of Fluid- or Cool types during stimulations.

 When transporting the equipment on the trolley, please keep the Flexible Arm in upright position.

 Always place the system with trolley on

 Be careful when you stimulate patient

with implanted devices or metallic objects located also in areas outside the 30cm distance from the coil during rTMS. Examples include: sutures and implanted insulin pumps.

 Adverse effects as scalp pain, headache and burning sensation can appear during and after stimulation on the head. Ref.: the guideline “Safety of TMS Consensus Group, Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research” by Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Clin Neurophysiology. 2009 Dec;120(12):2008-39.

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a flat horizontal surface and lock the two front wheels. Risk of sliding if placed on a non-flat horizontal surface.

 If a coil is mounted in the Flexible Arm

on the trolley, the coil must be placed above the MagPro cabinet and with the arm locked, to protect the coil from impacts during transport of the system.

 Changes in noise level or sound

frequency from the coil during stimulation may indicate beginning damages inside the coil. Stop using the coil and contact a Service Center; otherwise it may disintegrate.

Safety Information

Safety Checks

 Always carefully examine the coil

handle, housing and cables for cracks, marks, deformations, color changes and other signs of damage before using it. Do not use the coil if there is any evidence of stress failure; otherwise it may disintegrate.

 The coil must not be submersed into

any conductive liquid, including water. The encapsulation tolerates low levels of surface moist - but in general care should be taken to keep all surfaces clean and dry.

 Do not remove cover; Electric shock

hazard. Any maintenance inside the device must be performed by qualified service personnel.

 Do not connect USB cables to the USB port.

 Service must be referred to your local distributor.

The following safety checks should be conducted by the operator daily before use:

 Inspection for visible damage to device.  Inspection of main cords and connecting cables.

 Check the coil for damages, cracks,

marks, deformations, color changes and other irregularities. Do not use the coil if there is any evidence of stress failure and contact Tonica or a service center.

The following safety checks should be conducted (by qualified personnel) at least once a year and in the event of repair:

 Insulation of resistance.  Measurement of leakage currents.  Measurement of resistance of protective earth conductor.

 Inspection and cleaning of the fan filter

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Safety Information

Patient Safety Using the technique “Repetitive Transcranial Magnetic Stimulation” referred to as “rTMS”, is relevant in several cases, when used as a diagnostic or monitoring tool. When using rTMS, please take the following information as a general guideline. For more information on the subject always consult the literature, eg. the articles referred below. A note of caution must be sounded concerning the use of fast repetition rate cortical stimulation. Low repetition rate cortical stimulation is generally safe and has been used on many thousands of subjects, both patients and normal volunteers, with few adverse effects. Fast repetition rate cortical stimulation, at intensities above motor threshold, has however been reported to cause seizures in persons whether any prior abnormality. Because of the number of technical variables involved (stimulus strength, pulse repetition rate, pulse burst length, inter-burst interval, coil geometry, coil position and stimulator waveform) as well as possible seizure threshold variations between subjects, it may be very difficult to predict with accuracy a safe upper limit for any given stimulation protocol. Until further progress is made in defining safe regimes, the use of rapid rate cortical magnetic stimulation at levels approaching motor threshold should be treated with considerable caution. (Nilsson, Panizza, Grandofi) To read more about safety, please refer to the following references: 1. “Safety of different inter train intervals for repetitive transcranial magnetic stimulation and recommendations for safe ranges of stimulation parameters” by: Robert Chen, Christian Gerloff, Joseph Classen, Eric M. Wassermann, Mark Hallet, Leonardo G. Cohen. Electroencephalography and clinical neurophysiology. 1997 Dec; 105(6):415-21.

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2. “Risk and Safety of Repetitive Trans cranial Magnetic Stimulation: Report and suggested guidelines from the International Workshop on the safety of Repetitive Magnetic Stimulation, June 5-7, 1996” by Eric M. Wassermann. Electroencephalography and clinical neurophysiology. 1998 Jan; 108(1):1-16. 3. “Tolerability and Safety of High Daily Doses of Repetitive Transcranial Magnetic Stimulation in Healthy Young Men” by: Anderson B, Mishory A, Nahas Z, Borckardt JJ, Yamanaka K, Rastogi K, George MS. The journal of ECT. 2006 Mar; 22(1):49-53 4. “Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial” by: O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Biol Psychiatry. 2007 Dec 1;62(11): 1208-16. 5. “Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research” by Rossi S, Hallett M, Rossini PM, PascualLeone A.Clin Neurophysiology. 2009 Dec;120(12):2008-39 The articles are available at the Pubmed online database (www.pubmed.gov).

Safety Information

Safety Guideline Warning: Rapid cortical stimulation can induce seizures. Ensure that appropriate safety measures are taken. NEVER exceed the maximum safety recommendations stated in Figure 1, Figure 2 and Figure 3 below and be aware of the dependency of pulse frequency and % of MT. Safety Guideline is taken from “Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research” by Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Clin Neurophysiology. 2009 Dec;120(12):2008-39.

Figure 1: Safety recommendations for rTMS stimulation applied outside the motor cortex

Figure 2: Safety recommendations for rTMS stimulation applied to the motor cortex

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Safety Information

Figure 3: Safety recommendation for TBS (Theta Burst Stimulation) and QPS (Quadripulse stimulation)

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Safety Information

IEC 60601-1 Medical Electrical Equipment CAUTION When connecting, attention must be paid to:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. When connecting to a medical appliance with an F-type applied part or some additional equipment complying not with IEC 60601-1, but with the relevant safety standard for such equipment, the additional equipment: 1. Must either be placed outside the patient environment (the patient environment is any area in which intentional or unintentional contact can occur between patient and parts of the system (e.g. a printer) or as a result of some other person touching parts of the system) or 2. If placed within the patient environment, must be: a. Provided with additional protective earthing, or b. Supplied from an extra isolating transformer, limiting the enclosure leakage current to a value not exceeding 0.5 mA, or c. Supplied from a floating power supply, limiting the enclosure leakage current to a value not exceeding 0.5 mA Please refer to IEC 60601-1.

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Safety Information

IEC 60601-1 Classification Requirements Type of protection against electric shock:

 Class I: Equipment in which protection

against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation.

Degree of protection against harmful ingress of water:

 MagPro and Coils:

IPx0: Ordinary equipment (enclosed equipment without protection against ingress of water).

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide:

 Equipment not suitable for use in the presence of such a mixture.

Method(s) of sterilization or disinfecting recommended by the manufacturer:

 Please, see section on "Maintenance”

Mode of operation:

 Continuous operation

Degree of protection against electric shock:

 Type BF: Applied part providing a

particular degree of protection against electric shock, Particularly regarding: - Allowable leakage current - The applied part is electrically isolated (floating). - Not intended for direct cardiac application.

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What is Magnetic Stimulation?

What is Magnetic Stimulation? Magnetic stimulation is a non-invasive, pain free technique used to excite and depolarize neurons in the brain and peripheral nervous system using induced currents. The excitation is caused by weak electric currents induced in the tissue by rapidly changing magnetic fields. The discovery is based on the principle of electromagnetic induction – discovered in 1831 by British scientist Michael Faraday. When used to stimulate the brain, it is normally referred to as Transcranial Magnetic Stimulation (TMS). TMS can be either single or paired pulse TMS or repetitive Transcranial Magnetic Stimulation (rTMS). Single/paired pulse TMS is mainly used for physiological research and diagnostic purposes. When the magnetic stimulation is delivered at regular intervals, it is termed rTMS. When stimulating the brain rTMS can produce lasting effects on cerebral functions, such as improvement of mood in depression.

Magnetic stimulation is also applicable for purposes of mapping the cortical areas and their functions, for the study of connectivity in the neural networks and the functional significance of elements in a neural network for a given task. It can be used to evaluate intra-cortical excitability and modulate the level of excitability of a given cortical target beyond the duration of the stimulation.

Application possibilities Magnetic stimulation has become an invaluable tool for the evaluation of the human motor system in both health and disease. In clinical neurophysiology and neurology magnetic stimulation can be used to study central motor pathways and to examine patients with radiculopathies and plexopathies.

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Magnetic stimulation may not only help in our understanding of the neurophysiology of the human brain, but it also promises to enhance the value of imaging studies by adding information regarding the functional role of different (brain) areas.

Motor Threshold (MT) determination

Motor Threshold (MT) determination This section contains information on how to perform measurement of a patient’s motor threshold level.

The hand area of the motor cortex is approximately 5 cm below the centerline of the head (the vertex Cz) and on the interauricular line (the line going from ear to ear through the Cz) or in close proximity to this (around the dashed line on the drawing).

When a magnetic coil is discharged over the motor cortex and the discharge energy is above threshold value (MT), neurons are activated and the targeted muscles twitch. The MT is defined as: the minimum single pulse TMS energy needed to observe an Abductor Pollicis Brevis (APB) contraction. A stimulation protocol is often defined at a specified level related to the MT level, e.g. 120 % of MT. Consequently, MT determination is an important first step in the treatment procedure. Also, MT is patient specific and although it is relatively stable it can vary with time. The initial MT determination has two purposes: 1) to determine the location of the hand area of the motor cortex 2) to determine the minimum stimulation level (the MT) required for eliciting repeated twitching of the thumb. The MT determination is performed on the left hemisphere of the brain over the motor cortex area to activate the APB in the right hand. If stimulating the right hemisphere the activation is in the left hand. The patient is placed upright in a normal chair or a treatment chair.

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When locating the hand area of the motor cortex, use single stimulations with the MagPro stimulator intensity adjusted to 70%. For most patients this will ensure that the stimulation is above MT level. A few patients will have a higher MT value and for those a higher stimulation intensity has to be applied. Move the coil anteroposteriorly and mediolaterally in relation to the starting point in steps of 0.5 cm for locating of hot spot and muscle twitch is observed. An active muscle will lower the MT so it may help to ask the patient to tense up the thumb while searching for the optimal location. When an observable twitch of the right hand thumb is seen, the right localization has been found. When the right localization is found the MT value can be determined. Ask the patient to relax the thumb muscle in the right hand so that the resting MT level can be determined. During determination of the MT, keep the intervals between pulses random and with at least 3 seconds in between. Higher repetition rates may lead to a higher MT. Reduce the stimulation intensity to the lowest value which still induces a visible twitch in the right hand thumb 3 out of 5 stimuli or 5 out of 10 stimuli. Please note that sometimes it is not possible to stimulate the thumb alone and more fingers are stimulated simultaneously.

Presentation

Presentation The MagPro family consists of different models with different level of features. This chapter describes the differences between the models. The MagPro model name can be seen on the display during start-up. All features are described in the following chapters. Pay attention to that not all models includes a given feature.

Working Modes The device can work in following different modes: MagPro model

Modes

R30

Standard

R30 + MagOption

Standard Dual Twin

X100

Standard

X100 + MagOption

Standard Power Dual Twin

Standard Mode

Current Direction Current Direction in the Magnetic coil can be selected in following directions. MagPro model

Current Direction

R30

Normal

R30 + MagOption

Normal

X100

Normal or Reverse

X100 + MagOption

Normal or Reverse

Waveforms The device is a powerful and efficient magnetic stimulator, featuring following waveforms: MagPro model

Waveform

R30

Biphasic (Full-Sine)

R30 + MagOption

Monophasic Biphasic (Full-Sine)

X100

Monophasic Biphasic (Full-Sine) Biphasic Burst

X100 + MagOption

Monophasic Biphasic (Full-Sine) Halfsine Biphasic Burst

Typically chosen when operating with high repetition train sequence.

Repetition Rate

Twin/Dual Mode When running in twin/dual mode, the MagPro can provide up to 50 twin pulses per second with an inter pulse interval down to 1ms. Power Mode The Power Pulse is the most powerful mode to date. It allows all waveforms to be extended in pulse width and peak with approximately 40%.

The device can operate up to following repetition rates: MagPro model

Max. Rep. Rate

R30

30pps

R30 + MagOption

30pps

X100

100pps

X100 + MagOption

100pps

pps: pulses per second

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Presentation

Features Software

1

The general user interface in MagPro is logical and well organized, enabling the operator to overview all functions. The Status Area displays e.g. Coil Temperature, Available Stimuli and Coil Type. All the displayed information is shown in an easily readable form. MagPro can save and load customized settings, storing all parameters in a stimulation sequence. The device can show the actual as well as the predefined settings.

2 5 3

The coil connectors of MagPro fit most of the stimulating coils from MagVenture (see the Accessories Catalogue).

6 4

The MagPro has the ability to combine and control external equipment via the In/Out triggers. If external triggers are selected, the device can be controlled from an external device e.g. the Keypoint®.

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7

1

Magnetic Stimulating Coil

2

MagPro

3

MagOption

4

Trolley

5

Flexible Arm for Coil

6

Coil Cooler Unit

7

Isolation Transformer

Symbols and Connections

Symbols and Connections

Power ON/OFF button (2) The power switch is located in the lower right part of the rear panel to allow easy access, when turning the device on.

Rear Panel Follow instruction for use. See the accompanying documentation.

Earth Connectors / Equipotentiality (3 + 4)

CAUTION Electric shock hazard. Do not remove cover. Refer servicing to qualified service personnel.

To ensure a safe patient environment, we strongly recommend effective grounding of the various items of the equipment. For this purpose, two connectors are provided. When connecting additional pieces of equipment to the device, please pay attention to the maximum permissible leakage currents as per IEC 60601-1. Interference WARNING Electrical equipment for medical use requires special EMC precautions and needs to be installed and serviced according to the EMC documentation of the device. Serial ports (6 + 7) The serial COM1 and COM2 connectors are used for interface to other equipment. COM1 is used for interface to a MEP Monitor unit and COM2 for data export to and stimulator control from an external computer.

1

Mains Socket

2

ON / OFF button

3

Equipotentiality

4

Earth Connector

COM1

6

COM1 Serial Port (MEP Monitor)

COM2

7

COM2 Serial Port (Data Export and External Control)

8

Trig in/Trig out

10

USB Port, only for internal use.

SN xxx P/N

Triggering of other equipment from MagPro and triggering of MagPro from other equipment is possible. Special trigger cable must be used. USB ports (10)

Serial number Part number The device complies with the EC directive 93/42/EEC on medical device

2014-12

Trig in/Trig out connector (8)

Date of manufacture (Year-Month) Waste Electrical and Electronic Equipment: Compliance information

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These ports must only be used for export of data supported by the Data Transfer program. See separate documentation. The USB port is also used for updating of the MagPro software. There are some restrictions to models of USB memory sticks. See page 47 for further information.