Magstim MRI Coil Operating Manual

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1 Magstim MRI Coil Operating Manual

2 TABLE OF CONTENTS Page Numbers Section 1: Warranty 1 Section 2: Section 3: Indications for Use Contraindications Magstim MRI Coil Introduction D70mm MRI Coil System Coil Positioning Bi Phasic Stimulation Section 4: Warnings and Precautions 4 Section 5: Operating Instructions 6 Section 6: Maintenance: User Maintenance Technical Maintenance Cleaning Disposal Servicing Device Lifetime Section 7: Specifications: General Specifications Technical Specifications Stimulation Duration Limits Coil Compatibility Chart Ambient Temperature Requirements

3 SECTION 1: WARRANTY Equipment manufactured by the Magstim Company Limited is fully guaranteed covering materials and workmanship for a period of one year from the date of shipment. The Magstim Company Limited reserves the right to perform guaranteed services in its factory, at an authorised repair station, or at the customer's installation. The Magstim Company's obligations under this guarantee are limited to repairs or at the company's option, replacement of any defective parts of our equipment, except batteries, without charge if said defects occur during normal service. Claims for damages during shipment must be filed promptly with the transportation company. All correspondence concerning the equipment must specify both model name and/ or number and serial number, as it appears on the invoice for said equipment. Improper use, mishandling, tampering with, or operation of the equipment without following specific operating instructions will void this guarantee and release the Magstim Company from any further guarantee obligations. The Magstim Company will only accept responsibility for the effects on safety, reliability and performance of the equipment if: i modifications or repairs are carried out by persons authorised by The Magstim Company. ii the electrical installation of the relevant room complies with local regulations, and iii the equipment is used in accordance with the instructions for use. The Magstim Company Limited

4 SECTION 2: INDICATIONS FOR USE CAUTION INVESTIGATIONAL DEVICE Federal or (U.S.) law limits this device to investigational use. CAUTION Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of state in which he/ she practices to use or order the use of the device. The MRI Coil is a stimulating device intended for use with the Magstim Rapid for the stimulation of neural tissue. It may be used inside or outside of an MRI unit. CONTRAINDICATIONS The MRI Coil should not be used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted defibrillators and/or implanted neurostimulators. The Magstim Company Limited

5 SECTION 3: MAGSTIM MRI COIL INTRODUCTION This document is written for users of the MRI Coil, which is an investigational device. The MRI Coil is designed for providing cortical magnetic stimulation within a Magnetic Resonance Imaging (MRI) scanner. The coil is designed to be used in conjunction with the Magstim Rapid stimulator. When using the MRI Coil with the Rapid 2 stimulator the coil must be connected to the stimulator via a Magstim coil adaptor, part number The discharge current through the stimulating coil generates a high intensity magnetic pulse. When the coil is applied to a conductive medium, such as the human body, eddy currents are produced by electromagnetic induction, which causes stimulation to the tissue. D70mm MRI Coil System The D70mm MRI System (p/n ) consists of the following :- MRI D70mm Coil p/n MRI Heat Sensor Box p/n Footswitch Assembly p/n COIL POSITIONING Correct coil positioning is essential to allow accurate measurements of the important parameters such as conduction latency, threshold of stimulation, response size and waveform morphology. Bi-phasic Stimulation The Magstim Rapid are bi-phasic, resulting in current flow through the coil in both directions. If the induced stimulus is important to the recorded result, the most suitable coil orientation should be established before proceeding to record from the subject. The turquoise arrows represent the direction of the coil discharge current during the initial, rising phase of the discharge waveform. The Magstim Company Limited

6 SECTION 4: WARNINGS AND PRECAUTIONS CAUTION: Magnetic Stimulation has not been cleared by the FDA for cortical stimulation. This must not, therefore, be attempted. Investigational uses require the use of an IDE. CAUTION: In the USA, Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/ she practices to use or order the use of the device. WARNING This MRI coil should be used with the Magstim Rapid only and not be used in MRI scanners with Magnetic fields greater than 3 Tesla. Attention: Consult accompanying documentation before using the MRI Coil. CAUTION: The Magstim Magnetic Stimulators and their Stimulating Coils must not be used on, or in the vicinity of, patients or subjects with cardiac demand pacemakers, implanted defibrillators, or other electronic implants. The MRI Coil generates high intensity magnetic pulses. The induced eddy current is of sufficient magnitude to stimulate nerves and muscle. The strong magnetic pulses generated by the MRI Coil induce eddy currents in any conductive medium such as the human body, nearby metallic objects or electronic devices. NB Particular care must be taken to ensure that leads connected directly to the patient, or other equipment, are not in a position where the MRI Coil can couple resulting in currents being induced in them. Do not discharge the Magstim with the MRI Coil in the vicinity of metallic objects or these may be projected. The MRI Coil and its Temperature Sensor Box must not be used in an explosive atmosphere or in the presence of flammable anaesthetics. When the magnetic pulse is delivered, a discharge click is produced by the MRI Coil. This discharge click may startle. Where possible avoid the use of the MRI Coil near the ears. The use of ear plugs is recommended. The Magstim Company Limited

7 High voltages are present within the MRI Coil and its Temperature Sensor Box. Do not remove the covers. Refer servicing to qualified personnel. The Stimulating Coil and its Temperature Sensor Box must not be used if there are any signs of external damage or if any parts are damp or wet. Cortical magnetic stimulation runs the risk of inducing seizures. Do not discharge the MRI Coil in the vicinity of objects sensitive to magnetic fields. Examples are credit cards, floppy disks and computer screens. 40 o The MRI coil has no build in temperature sensors. The coil surface temperature is predicted by the sensor box. Protection circuits in the Magstim magnetic stimulator disable the equipment if the temperature of the MRI Coil is predicted above 40 o C. To ensure the correct operation of this tracking and hence prediction the Coil and Sensor Box must always be used as the same pair. Also the MRI Coil system should be allowed to cool for at least 20 minutes before further stimulation once the system has been disabled following over temperature. Coils must not be immersed in water, put in an ice bucket, or refrigerated. Not even if placed within a plastic bag. The coils do not have any specialised protection against the ingress of liquids, therefore conditions where ingress of liquid, or the forming of condensation within the coil, can occur must be avoided as the electrical insulation will be compromised. Cooling must only be performed by using a flow of cool air from a fan or air conditioning unit. Due to thermal lag, the surface temperature of the MRI Coil will continue to rise following the coil over-temp activating and forcing the main unit into a standby condition. Therefore, the Coil must be removed from the patient as soon as the replace coil symbol is illuminated. Allow the MRI Coil system to cool for at least 20 minutes before further stimulation. There are currently few medical papers available regarding the effects of magnetic stimulation on the unborn child/ foetus or the expectant mother. As a result of this, we are unable to verify the safety of the Coil's use on, or by, pregnant women. We recommend that anyone wishing to use the Coil on a pregnant woman, or use it whilst pregnant, should contact the Magstim Company Ltd. for more information as new medical papers become available. On no account must the MRI Coil and Temperature Sensor Box be used in environmental conditions outside those specified in this operating manual. The Magstim Company Limited

SECTION 5: OPERATING INSTRUCTIONS ( for more detailed operating instructions see main Magstim Operating Manual ) NB At the start of each session the Operator must check the plastic casing of the MRI

8 SECTION 5: OPERATING INSTRUCTIONS ( for more detailed operating instructions see main Magstim Operating Manual ) NB At the start of each session the Operator must check the plastic casing of the MRI Coil and Temperature Sensor Box for any signs of external damage. If any cracks are visible in the housing, the Stimulating Coil must not be used and should be returned for servicing and repairs. 1. Connect the Coil to the Temperature Sensor Box This box performs the temperature monitoring function for the coil to ensure that its temperature does rise above the permitted level for patient contact. The MRI Coil will not operate if it is connected directly to the Magstim. 2. Connect the Footswitch to the Temperature Sensor Box. This footswitch replaces the safety interlock switches traditionally found on Magstim coils. The MRI Coil has no safety interlock switches mounted in the coil, this is to avoid interference with MRI scanner images. The MRI coil will not operate unless this footswitch is depressed. 3. Connect the Temperature Sensor Box to the main Magstim unit. Go through the set-up procedure detailed in the main Magstim unit Operating Manual, select the desired stimulating power by using the OUTPUT POWER knob, and press the RUN switch on the front panel of the Magstim to arm the unit. The Magstim will charge and the READY indicator will be illuminated. 4. Position the Stimulating Coil on the desired area to be stimulated. Ensure the Temperature Box footswitch is depressed when ready. Triggering the Magstim results in a magnetic pulse being delivered by the Stimulating Coil, stimulating the nerves beneath it. 5. When necessary, reposition the Stimulating Coil and/ or modify the stimulating power level to suit the requirements for the next stimulus. Meanwhile, the Magstim will recharge and can be triggered once again in the normal manner. 6. When the tests have been completed, press the STOP switch on the front panel of the Magstim. The Magstim will then revert to STANDBY mode and cannot be triggered until it is armed once more. The Magstim Company Limited

9 SECTION 6: MAINTENANCE USER MAINTENANCE The user should inspect the Stimulating Coil and Temperature Sensor Box at the beginning of each session for signs of external damage. Do not use the Coil, or its Temperature Sensor Box, if any cracks are visible or the insulation is in any way damaged. TECHNICAL MAINTENANCE The coil pins should be checked carefully after every 100 shots for any signs of pitting, or burning, as under conditions of exceptionally hard use at high energy levels, it is possible for the localised heating to manifest itself in the form of micro-welds. Continued used in this condition will eventually result in the coil pins/sockets becoming totally eroded and open circuit. NB The pin burning is communicable - any coil with good pins that is used on a stimulator with burned socket pins will have its pins damaged immediately. The reverse is also true, a socket with good pins that has a coil with burnt pins connected to it will have its pins damaged immediately. If damage is noticed on any coil connector or stimulator coil socket the complete system must not be used until all pins and sockets are carefully examined for any damage. If any contacts show damage, even if slight, they will need to be changed. If this is not done thoroughly there is the risk that the cycle of contact damage will continue. As contact repair is a specialised procedure, it is recommended that contact replacement is undertaken by the Magstim Company, or one of its authorised service centres. If additional advice or information is required, please contact The Magstim Company. CLEANING The Stimulating Coils may be cleaned using an isopropyl alcohol moistened cloth. Ensure that the stimulating coil has dried thoroughly before use. Note: This coil cannot be sterilised. Do not allow the coil to become contaminated with bodily fluids. DISPOSAL When the MRI Coil and its Temperature Sensor Box reach the end of their serviceable life, the Magstim Company Limited should be contacted, at the address listed under the Servicing section, to arrange for their disposal in compliance with the appropriate environmental regulations. The Magstim Company Limited

10 SERVICING There are no user serviceable parts within the MRI coil system. Un-authorised persons must not remove the screws securing the covers of the Heat Sensor Box. The MRI Coil and its Temperature Sensor Box must be returned immediately to the Magstim Company Ltd., or the dealer, if there are any signs of external damage. It is also advisable that they are returned for servicing after two years of use. For servicing information contact the Magstim Company Limited at: Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, United Kingdom Tel: + 44 (0) Fax: + 44 (0) service@magstim.com Website: DEVICE LIFETIME The lifetime of the MRI Coil and Temperature Sensor Box is defined as being 2 years from the date of shipment. The Magstim Company Ltd. will support the product for the duration of its lifetime. The Magstim Company Limited

11 SECTION 7: COIL SPECIFICATIONS GENERAL SPECIFICATIONS The stimulating coil is classified as a type BF applied part when used with the Magstim Rapid. This means that the external surfaces of the coil are electrically isolated from the other parts of the equipment as required by safety standards of BSEN The MRI Coil and Temperature Sensor Box are designed to comply with the requirements of the Safety Standard EN (90), including amendment 1 (91) and amendment 2 (95). Protection against ingress of liquids - The MRI Coil and its Temperature Sensor Box are classified as IPXO (Not Protected), as there is no specialised protection provided against the ingress of liquids. Protection against flammable anaesthetic mixtures Not Protected. Therefore, the MRI Coil and its Temperature Sensor Box are not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. EMC Susceptibility To avoid interference problems the Magstim Rapid, and the MRI Coil and its Temperature Sensor Box, should not be used in the vicinity of any equipment that does not comply with EMC Standard EN , including mobile phones. This product is CE marked per the requirements of the European Medical Device Directive 93/42 TECHNICAL SPECIFICATIONS Inductance Between, 20 to 25µH (Coil+Temperature Sensor Box) Max Magnetic Field Between, 0.8T to 1T (Rapid at 100%) MRI Coil cable length MRI Coil & Cable weight Temperature Sensor Box & Cable length Temperature Sensor Box & Cable weight Magnetic Field Environment 7m 3.8kg 1m 1.66kg 3 Tesla Maximum* * This coil should not be used in magnetic fields greater than 3Tesla The Magstim Company Limited

12 STIMULATION DURATION LIMIT Max. No. of Stimulations at 50% Power (Per Hour) Max. No. of Stimulations at 80% Power (Per Hour) Max. No. of Stimulations at 100% Power (Per Hour) < 800 < 400 < 200 COIL COMPATIBILITY CHART Coil Magstim 200 Magstim Rapid 2 MRI Coil No Yes (with coil adapter ) Magstim Magstim Magstim 250 Bistim Rapid No No Yes AMBIENT TEMPERATURE Permissible Environment Conditions for Transport: Ambient Temperature Range: Relative Humidity Range: Atmospheric Pressure Range: -25 o C to 60 o C 10% to 80% Non Condensing 50kPa to 106kPa Storage and Operating Conditions Operating Temperature: Storage Temperature: Atmospheric Pressure Range: 5 o C to 40 o C -25 o C to 60 o C 50kPa to 106kPa The Magstim Company Limited

Magstim Coils & Accessories. Operating Manual

Magstim Coils & Accessories. Operating Manual Magstim Coils & Accessories Operating Manual 1623-23-06 GUARANTEE Equipment manufactured by the Magstim Company Limited is fully guaranteed covering materials and workmanship for a period of one year from