Magstim Air-Cooled Double 70mm Coil System Operating Manual

GUARANTEE

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.

© 1999, The Magstim Company Limited, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, Wales, U.K. All right reserved. No part of this manual may be reproduced without the written permission of the Magstim Company Limited. Magstim is a Registered Trade Mark.

Air Cooled Double 70mm Coil System

TABLE OF CONTENTS

Page Numbers Section 1: Introduction

1

Coil Positioning

1

Section 2:

Warnings and Precautions

2

Section 3:

Operating Instructions

5

Section 4:

System Assembly

6

Section 5:

System Specifications

7

Maximum Duration of Continuous Use

8

Section 6:

Maintenance: User Maintenance Technical Maintenance Cleaning Servicing

9 9 9 10

Section 7:

Filter Change Instructions

11

Section 8:

Filter Change Record

12

Section 9:

Coil Operation Record

13

Section 10:

Customer Survey Questionnaire

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Air Cooled Double 70mm Coil System

SECTION 1: The Magstim Air-Cooled Double 70mm Coil System

INTRODUCTION

This document is written for users of the System (1600-00). The system is designed to be used in conjunction with the Magstim Rapid Magnetic Stimulator, for the magnetic stimulation of neuromuscular tissue and the motor cortex. The system comprises:- Magstim Air-Cooled Double 70mm Stimulating Coil (1640-00), Coil Stand (1261-00), Vacuum Unit (1618-00).

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.

The Magstim RAPID is bi-phasic, resulting in current flow through the coil in both directions.

Stimulating the motor cortex using the Air-Cooled Double 70mm Coil produces responses which can be recorded from the majority of muscles in the body, allowing for the functional assessment of motor pathways.

When recording from muscles in the arms and hands, position the coil centrally on the vertex. Optimum stimulation takes place under the mid-point of the coil. When recording from muscles in the lower limbs, move the coil forward from the vertex and contra lateral to the target muscle by approximately 2 inches each way, such that part of the coil winding lies over the central fissure.

The Magstim Company Limited

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SECTION 2:

USA Only

WARNINGS AND PRECAUTIONS

CAUTION: Magnetic Stimulators have not been cleared by the FDA for cortical stimulation. Investigational human uses require that the user complies with the FDA regulations regarding Investigational Devices. Please visit www.fda.gov/cdrh or www.magstim-us.com for more information. 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.

Attention: Consult accompanying documentation before using the Stimulating Coil.

CAUTION: The Stimulating Coil must not be used on, or in the vicinity of, patients or subjects with cardiac demand pacemakers, implanted defibrillators, or other electronic implants. The Stimulating 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 Stimulating 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 Stimulating Coil can couple resulting in currents being induced in them. Do not discharge the Magstim Magnetic Stimulator with the Stimulating Coil in the vicinity of metallic objects or these may be projected, moved and/or damaged. The Stimulating Coil 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 Stimulating Coil. This discharge click may startle.

Where possible avoid the use of the Stimulating Coil near the ears. The use of ear plugs is recommended.

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High voltages are present within the Stimulating Coil during operation. Do not remove covers. Refer servicing to qualified personnel. The Stimulating Coil 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 Stimulating Coil in the vicinity of objects sensitive to magnetic fields. Examples are credit cards, floppy disks and computer screens.

40o

Protection circuits in the Magstim Magnetic Stimulator disable the equipment if the temperature of the Stimulating Coil exceeds 40oC. 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 through the vacuum unit. Due to thermal lag, the surface temperature of the Stimulating 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. Do not allow the air inlets to become restricted or blocked, as this will cause the vacuum motor to overheat. With continuous use under these conditions, permanent damage may be caused to the vacuum unit. 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 Stimulating Coil be used in environmental conditions outside those specified in this operating manual.

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Air Cooled Double 70mm Coil System

IMPORTANT The Magstim Air-Cooled Double 70mm Coil is designed for use with the Magstim Rapid and Super Rapid systems. It should not be used with any other magnetic stimulator. The Cooled Coil System should only be used by persons who have the necessary knowledge to use the system in a safe and effective manner. The Vacuum Unit, with which the system is designed to operate, is a nonmedical device and should therefore be located outside the Patient Environment during operation. The Patient Environment being the area enclosed within a distance of 1.5m from the patient. The Magstim Air-Cooled Double 70mm Coil must not be used without a filter fitted. If there is no filter fitted debris may be drawn into the coil, causing a breach of the electrical insulation. If the coil is used without a filter fitted the warranty will be invalidated.

The Magstim Company Limited

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Air Cooled Double 70mm Coil System

SECTION 3: 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 Stimulating Coil 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. The Operator must also check the filters to ensure that they are not soiled. If the coil is used with soiled filters the cooling performance will be reduced. Due to the orientation of the coil connector assembly, it is not possible to open the door of the booster cabinet with the coil connected. It is therefore recommended that the booster units be turned on prior to connecting the coil.

1.

Connect the Coil to the main Magstim Unit, and the Vacuum Unit – NB the Vacuum Unit requires its own individual 10A - 115V, 5A - 230V power outlet. Switch on both units. Select the desired stimulating power by using the OUTPUT POWER selector, and press the RUN switch on the front panel of the Magstim to arm the unit. The Magstim will charge and the READY display will be illuminated.

2.

Position the Stimulating Coil in the Coil Stand (or other clamping device), away from any objects that may be repelled or damaged by the coil discharge and away from any sources of dust or debris that may clog the coil filters. Adjust coil orientation, as necessary, to achieve stimulation of desired area.

3.

Press and hold down one or both of the safety switches located on the handle of the Stimulating Coil. Triggering the Magstim results in a magnetic pulse being delivered by the Stimulating Coil, stimulating the nerves beneath it. The safety switches are fitted to prevent accidental energisation of the coil. The Magstim Rapid will not trigger if the switch/es are not pressed.

4.

When necessary, reposition the Stimulating Coil and/or modify the stimulating power level (or frequency, where applicable) to suit the requirements for the next stimulus. The Magstim can be triggered once again in the normal manner.

5.

When the tests have been completed, press the STOP switch on the front panel of the Magstim and replace the Stimulating Coil on the Coil Hanger. The Magstim will then revert to STANDBY mode and cannot be triggered until it is armed once more.

IMPORTANT The Vacuum Unit is supplied as a dedicated unit. On no account should it be used for anything other than the cooling of the stimulating coil. To do so would clog the internal filters of the unit and result in impaired air flow through the coil. The Cooled Coil has been designed for use in conjunction with the Vacuum Unit. Therefore it must not be used without the Vacuum Unit in operation.

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Air Cooled Double 70mm Coil System

SECTION 4: SYSTEM ASSEMBLY

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SECTION 5: SYSTEM SPECIFICATIONS Classification The Air-Cooled Double 70mm Coil is intended for use in conjunction with the Magstim Rapid Rate Stimulator, where the whole set up is classified as Class 1, Type BF. The degree of protection provided by the coil enclosure against ingress of liquids is classified as IPX0. The Vacuum Unit, with which the system is designed to operate, is a non-medical device and should therefore be located outside the Patient Environment during operation, the Patient Environment being the area enclosed within a distance of 1.5m from the patient. The coil is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. Magnetic Field Output - when used in conjunction with the Magstim Rapid Max. magnetic field strength: Minimum Inductance:

0.93 T (coil surface) <0.1mT (1m away from the coil) 15 µH

Mode of Operation Continuous at 100% Power at a frequency of 1Hz. Ambient Temperature

Permissible Environment Conditions for Transport and Storage: -25oC to 60oC 10% to 80% Non Condensing 50kPa to 106kPa

Ambient Temperature Range: Relative Humidity Range: Atmospheric Pressure Range:

Operating Conditions: 5oC to 35oC 30% to 75% Non Condensing 70kPa to 106kPa

Operating Temperature: Relative Humidity Range: Atmospheric Pressure Range

Features Localised magnetic pulses Double electrical insulation Dual temperature sensors Dual safety switches High impact ABS cover General Overall length

4m

Coil Weight

2.5 kg

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Cooled Coil Maximum Duration Of Continuous Use (Using a Rapid System with four boosters)

The following data was obtained at an ambient temperature of 26oC. Protocol 1:

10 second train at a frequency of 10Hz,with a 50 second inter-train interval

Power Level 50% 80% 100%

No. of Trains > 60 > 60 > 60

NB The number of trains is booster dependant.

Protocol 2: 5 second train at a frequency of 25Hz, with a 26 second inter-train interval

Power Level 50% 80% 100%

Protocol 3:

No. of Trains > 30 ( booster dependant ) 10 4

continuous single shot at a frequency of 1Hz

Power Level 50% 80% 100%

The Magstim Company Limited

No. of trains > 3600 > 3600 > 3600

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SECTION 6: MAINTENANCE

USER MAINTENANCE The user should inspect the Stimulating Coil at the beginning of each session for signs of external damage. Do not use the coil if any cracks are visible or the insulation is in any way damaged. The Operator must also check the filters to ensure that they are not soiled. If the coil is used with soiled filters the cooling performance will be reduced. The Coil Air Filters should be changed as soon as they become soiled. If the filters are not changed regularly, the air flow will become impaired, reducing the efficiency of the cooling system. It is recommended that the filters are checked after every 10 hours of use. For instructions on how to change the coil air filters, see following page. 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 Coil and the Vacuum Unit may be cleaned using a cloth moistened with isopropyl alcohol. Ensure that the Stimulating Coil and the Vacuum Unit have dried thoroughly before use.

The Magstim Company Limited

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SERVICING The Stimulating Coil 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 the coil is 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) 1994 240 798 Fax: + 44 (0) 1994 240 061 email: [email protected]

DISPOSAL When the Cooled Coil and accessories reach the end of their serviceable life, the Magstim Company Limited should be contacted, at the above address, to arrange for their disposal in compliance with the appropriate environmental regulations.

The Magstim Company Limited

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SECTION 7: FILTER CHANGE INSTRUCTIONS The filters (two of) should be replaced only with Magstim Double 70mm Cooled-Coil Filters – Part No. 1886/10/00. The Magstim Company will not be held responsible for any related damage sustained to the coil, or for any reduction in system performance, if anything other than the correct Magstim filters are used. IMPORTANT Before commencing filter change, ensure that:1. The coil is disconnected from the Magstim Rapid. 2. The filter change is to be performed by technical personnel only. i. Unscrew coil filter cover. ii. Remove the two soiled filters, and replace with new ones.

iii. Screw on the coil filter cover to its original position. Check that the coil filter cover is securely in place before allowing the coil to be used.

Filter Well

2 x Filters

Coil Filter Cover

Disposal of used filters The filters may be disposed of in the general waste disposal unit. There are no special conditions of disposal required.

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SECTION 8: FILTER CHANGE RECORD

Filter changed by:

Name: ………………………………… Signature:……………………

Reason for change:

…………………………………… …………………………………… …………………………………… ……………………………………

Date: ……………………..

Filter changed by:

Name: ………………………………… Signature:……………………

Reason for change:

…………………………………… …………………………………… …………………………………… ……………………………………

Date: ……………………..

Filter changed by:

Name: ………………………………… Signature:……………………

Reason for change:

…………………………………… …………………………………… …………………………………… ……………………………………

Date: ……………………..

Filter changed by:

Name: ………………………………… Signature:……………………

Reason for change:

…………………………………… …………………………………… …………………………………… ……………………………………

Date: ……………………..

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SECTION 9: COIL OPERATION RECORD Operators Name

Date

The Magstim Company Limited

Hours of Use

13

Total Hours of Use Since Filter Change

Signature

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Air Cooled Double 70mm Coil System

SECTION 10: CUSTOMER SURVEY QUESTIONNAIRE Please complete and return when convenient

Name: ………………………………………………………………………………… Hospital/Clinic: ……………………………………………………………………….

1.

No. of sessions the coil has been used for . ……………………….

2.

Average duration of each session. ………………………………..

3.

At what power level and frequency did you operate the system ? ……………….. ………………………………………………………………………………………

4.

Did the Cooled Coil perform satisfactorily during each session ? ………………… If not, give details of any problems experienced with the operation of the coil. ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… …………………………………………………………………………………………

5.

Was the noise level produced by the system acceptable ? …………………………… If not, which part/s of the system produced an unacceptable level of noise and to what degree was it unacceptable ? ………………………………………... …………………………………………………………………………………………. ………………………………………………………………………………………….

6.

Were there any problems experienced in connecting up the system ? ……………….. If yes, please give details ……………………………………………………………… …………………………………………………………………………………………. ………………………………………………………………………………………….

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7.

To what degree did the Cooled-Coil improve the continuity and/or effectiveness of treatment compared to the standard Double 70mm Coil ? …………………………………………………………………………………………… …………………………………………………………………………………………… ………………………………………………………………………………………….. ………………………………………………………………………………………….. …………………………………………………………………………………………..

8.

If you have any comments to make on issues that have not already been raised, please do so below. ……………………………………………………………………………. …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… …………………………………………………………………………………………… ……………………………………………………………………………………………

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