Magstim 2nd Generation Coils & Accessories. Operating Manual

Transcription

1 Magstim 2nd Generation Coils & Accessories Operating Manual

2 TABLE OF CONTENTS Page Numbers Guarantee: 1 Section 1: Magstim 2 nd Generation Coils & Accessories: 1.1 Introduction 1.2 Indications for use 1.3 Caution 1.4 Contraindications 1.5 Coil Positioning & Stimulation nd Generation Extension Cable 1.7 Coil Adapter Section 2: Warnings and Precautions: 6 Section 3: Section 4: Section 5: Section 6: Appendix A: Appendix B: Operating Instructions: 3.1 General nd Generation Coils 3.3 Remote Control Coils nd Gen. Double 70mm Air-Cooled Coil nd Gen. Coil Extension Cable 3.6 Coil Adapter Coil Details: 4.1 Standard Coils 4.2 Remote Control Coils nd Gen. Double 70mm Air-Cooled Coil Maintenance: 5.1 User Maintenance 5.2 Technical Maintenance Pin Burning Filter Changing 5.3 Cleaning & Disinfecting 5.4 Servicing 5.5 Device Lifetime 5.6 Disposal Specifications: 6.1 General Specifications 6.2 Technical Specifications 6.3 Ambient Temperature Requirements Coil Error Codes Base System Error Codes Air-Cooled Coil Filter Change Record Air-Cooled Coil Operation Record

3 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 The Magstim Company Service Department only. 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. NB - If the Double 70mm Air-Cooled Coil is used without filters fitted the warranty will be invalidated. The Magstim Company Limited th April 2005

4 SECTION 1: 2 nd GENERATION COILS & ACCESSORIES 1.1 INTRODUCTION This manual is written for users of Magstim 2nd Generation Stimulating Coils and Accessories The 2 nd Generation Stimulating Coils and Accessories are designed to be used in conjunction with the Magstim Model 200 2, BiStim 2 and Rapid 2 Magnetic Stimulators for the magnetic stimulation of neuromuscular tissue. 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. This method of stimulation enables deep, and otherwise inaccessible, nerves to be stimulated easily and relatively painlessly. In addition, no skin preparation is required and stimulation can be achieved through clothing. 1.2 INDICATIONS FOR USE General Distribution The Magstim 2 nd Generation Coils and accessories are designed for use with the Magstim 200 2, BiStim 2 and Rapid 2 for the stimulation of neuromuscular tissue. The Magstim systems are for use by, or under the supervision of, a medical practitioner only. INDICATIONS FOR USE USA Only 1.3 CAUTION 1.4 CONTRAINDICATIONS The Magstim 2 nd Generation Coils and accessories are designed for use with the Magstim 200 2, BiStim 2 and Rapid 2 and are intended for the stimulation of peripheral nerves for diagnostic purposes. Note - 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. Federal law restricts these devices 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. The Magstim 2 nd Generation Coils and accessories 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 th April 2005

5 1.5 COIL POSITIONING & STIMULATION 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. In the Magstim Model the discharge current in the stimulating coil and the resulting magnetic pulse is mono-phasic, giving unidirectional current from the Magstim unit through the coil, allowing for mono-hemispheric stimulation. Therefore, the direction of the current relative to the stimulated tissue is dependent on the orientation of the coil. Circular Coils Standard 90mm Stimulating Coil mm Remote Control Stimulating Coil These have their faces labelled A and B respectively. With Side A visible and Side B facing the area to be stimulated, the coil current flows in an anticlockwise direction and the induced tissue current flows in the clockwise direction. If the coil head is reversed, so are the current directions. To record the best responses from the muscles in the left side of the body, always place the coil such that SIDE B is visible to the operator and SIDE A is touching the subject. For the right side of the body, this should be reversed. The dark blue arrows fitted to the faces of the stimulating coils represent the direction of the coil discharge current. The 90mm coil is primarily designed to easily stimulate the motor cortex to obtain responses from muscles in the arms and hands. When the centre of the coil is positioned over the vertex the mean diameter of the windings sit over the motor strip of both hemispheres. In the case of all circular coils, stimulation takes place under the winding and not the coil centre. When recording from muscles in the lower limbs, move the stimulating coil forward from the vertex and contra lateral to the target muscle by approximately 2 inches (50mm) each way, such that the mean diameter of the coil winding lies over the central fissure. The Magstim Company Limited th April 2005

6 Double Coil Standard Double 70mm Stimulating Coil Air-Cooled Double 70mm Stimulating Coil Double 70mm Remote Control Stimulating Coil Important The Magstim 2 nd Generation Air-Cooled Double 70mm Coil is designed for use with the Magstim Rapid 2 only. It should not be used with any other magnetic stimulator. These coils have their coil heads labelled with blue arrows, which, as in the single coils, represent the direction of the coil discharge current. The virtual cathode for these coils is approximate to the valley or trough formed by the conjunction of the two coils, directly opposite the handle towards the leading edge of the coil. In the case of the 2 nd Generation Air-Cooled Coil, in addition to the discharge current directional arrows, the coil also has, moulded into the plastic top cover, a minus symbol near the front and three arrows pointing towards it from the handle. These marks are intended to show the virtual cathode and the evoked current flow respectively. The evoked (induced) current is in the opposite direction to the coil discharge current, indicated by the turquoise arrows fitted to the coil. COIL SELECTION The Double 70mm Coil is more localised in its area of stimulation. Stimulating the motor cortex using the Double 70mm Coils produces responses which can be recorded from the majority of muscles in the body, allowing for the functional assessment of motor pathways. For reproducible results from cortical stimulation, the most effective site of stimulation should established and marked upon a lightweight, close fitting cap. For peripheral sites, the stimulation site can be marked with a suitable pen. 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 Rapid 2 is bi-phasic, resulting in current flow through the coil in both directions. The Magstim Company Limited th April 2005

7 1.6 2nd Generation Coil Extension Cable All Magstim 2 nd Generation and Remote Control Stimulating Coils, with the exception of the 2 nd Generation double 70mm Air-Cooled Coil, are fitted with 2m connecting cables. In some instances it is necessary for the Magstim Stimulator to be greater than 2m away from the coil head. The 2 nd Generation Coil Extension Cable, which is also fitted with a 2m interconnecting cable, allows the user to increase the Stimulator to Coil - head distance to a total of 4m. This allows increased flexibility of use, without introducing any significant reduction in stimulation. If, for specific cases, a total length of greater than 4m is required, the Magstim Company Ltd. should be contacted. Individual requirements can then be assessed to determine whether a viable solution is possible. The Magstim Coil Adapter The Magstim Coil Adapter is for use with the Magstim Model 200 2, BiStim 2 and Rapid 2 only. It has been developed to allow the use of the Magstim Original, and Custom, range of stimulating coils on the Magstim Model and the Rapid 2. It should not be used with the Magstim 2nd Generation stimulating coils, as they have been designed specifically for use with the Magstim 200 2, BiStim 2 and Rapid 2 and do not need an adapter. If a Magstim 2nd Generation Coil is connected via the Coil Adapter, the Stimulator will display an error message and will not arm. The Magstim Company Limited th April 2005

8 SECTION 2: WARNINGS AND PRECAUTIONS USA Only 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 or 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 Coils and Accessories. CAUTION: The Stimulating Coils and Accessories 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 Coils 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 Coils 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 Coils and Accessories can couple resulting in currents being induced in them. Do not discharge the Magstim Magnetic Stimulator with the Stimulating Coils in the vicinity of metallic objects or these may be projected, moved and/or damaged. The Stimulating Coils and Accessories 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 Coils. This discharge click may startle. Where possible avoid the use of the Stimulating Coil near the ears. The use of ear plugs is recommended. High voltages are present within the Stimulating Coils and Accessories during operation. Do not remove covers. Refer servicing to qualified personnel. The Magstim Company Limited th April 2005

9 The Stimulating Coils and Accessories 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 Coils in the vicinity of objects sensitive to magnetic fields. Examples are credit cards, floppy disks and computer screens. The 90mm Coil is intended for transient use, the surface temperature limits for which, being 50 o C. If it is intended that the coil be used for more prolonged contact, the proposed protocol must be run, prior to its application on a patient, to ensure that the surface temperature does not rise above 41 o C during operation. Coils and Accessories must not be immersed in water, put in an ice bucket, or refrigerated. Not even if placed within a plastic bag. The Coils and Accessories do not have any specialised protection against the ingress of liquids, therefore conditions where ingress of liquid, or the forming of condensation within the coils, 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 Stimulating Coils 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. 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 Coils use on, or by, pregnant women. We recommend that anyone wishing to use the Coils 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 Coils and Accessories be used in environmental conditions outside those specified in this operating manual. 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. The Double 70mm Air-Cooled Coil must not be used without the filters fitted, as dust and debris could be drawn into the coil, causing possible impairment of function or a breach of the electrical insulation. 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 Company Limited th April 2005

10 SECTION 3: OPERATING INSTRUCTIONS 3.1 General (For more detailed operating instructions see the Operating Manual for the Magstim Magnetic Stimulator). IMPORTANT To avoid interference problems the Stimulating Coils should not be used in the vicinity of any equipment that does not comply with EMC Standard EN , including mobile phones. At the start of each session the Operator must check the plastic casing of the Stimulating Coil and/or Accessory for any signs of external damage. If any cracks are visible in the housing, or there is damage to the cable insulation, the item must not be used and should be returned for servicing and repairs. In addition, when using the Double 70mm Air-Cooled Coil, the cooling system tubing must be checked for signs of damage/ breached insulation and the filters must be checked to ensure that they are not soiled. If the coil is used with soiled filters the cooling performance will be reduced. Care must be taken to connect the Stimulating Coil/ Accessory Plug to the Coil Socket correctly see diagram below. Failure to do so can cause internal arcing, resulting in damage to the connection pins, and in severe cases, internal damage to the coil/ accessory and Magnetic Stimulator. The Magstim Company Limited th April 2005

11 3.2 2 nd Generation Coil Operation (instructions relate to use with a Magstim ) 1. Connect the Coil 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 Control Unit of the Magstim to arm the unit. The Magstim will charge and the READY indicator will be illuminated. 2. Position the Stimulating Coil on the desired area to be stimulated. Hold the stimulating coil and press one of the Trigger Enable switches located on either side of the coil handle. Press and hold the TRIGGER key on the front panel, or depress and hold the footswitch. There should be a clicking noise emanating from both the stimulating coil and the Magstim, each time the Magstim is discharged, indicating that a magnetic pulse is being delivered by the Stimulating Coil, stimulating the nerves beneath it. 3. 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 have recharged and can be triggered once again in the normal manner. 4. When the stimulations have been completed, press the STOP switch on the Control Unit of the Magstim. Note 1. A magnetic pulse will only be produced if one or both of the safety switches at the base of the stimulating coil are pressed. On no account must the trigger and enable buttons on the stimulating coil be permanently activated, by taping down, or any other method of fixing. They are designed as a safety interlock, to disable them could result in a serious injury as a result of an inadvertent discharge of the coil. 2. If the instrument has not been triggered for over 1 minute after the READY symbol is illuminated the unit will automatically select the default mode and discharge internally. 3. Ensure the Stimulating Coil is functioning properly before proceeding. 3.3 Remote Control Coil Operation (instructions relate to use with a Magstim ) 1. Connect the Coil to the main Magstim unit. Go through stages 2 to 5 of the set-up procedure detailed in the main Magstim unit Operating Manual - Section 5 Preparations For Use. All LEDs and symbols on the Remote Control Coil will then illuminate within a period of 3 seconds. At the end of the 3 second period, the OUTPUT % DISPLAY will indicate an output power level of 30% (item 5 shown in Section 4 of this Operating Manual). Ensure that all indicator LEDs are functioning properly before proceeding; if not, contact The Magstim Company Service Department. The Magstim Company Limited th April 2005

12 2. Select the desired stimulating power by using the power up and power down buttons (items 4 and 6 respectively, shown in Section 4 of this Operating Manual). Individual presses of the buttons will either increment, or decrement the power level by 1%. If the button is pressed and held, the power level will continue to increase, or decrease, in 1% steps until the button is released, or the power level reaches 100%, or 0%. When the button has been depressed for a period of 3 counts, the rate of change of power level will approximately double. 3. Press, and hold, one of the Arm/Trigger buttons on the coil (button No. 1 shown in Section 4 of this Operating Manual) to arm the Magstim. The yellow LED indicator on the front of the Magstim will illuminate. The Magstim will then charge to the power level that you have selected. When the Magstim has completed charging the READY indicator (See item 7 shown in Section 4 of this Operating Manual) will illuminate. 4. Position the Stimulating Coil on the desired area to be stimulated. When you are ready to energise the coil, press the second Arm/Trigger button on the coil (whilst continuing to hold the first). There should be a clicking noise emanating from both the stimulating coil and the Magstim, each time the Magstim is discharged, indicating that a magnetic pulse is 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 have recharged and can be triggered once again in the normal manner. 6. When the stimulations have been completed, press the STOP switch on the Remote Control Coil (item No. 2 shown in Section 4 of this Operating Manual). The Magstim will then discharge itself internally and remain in the default mode until it is required for use. Note 1. On no account must the Arm/Trigger buttons on the stimulating coil be permanently activated, by taping down, or any other method of fixing. They are designed as a safety interlock, to disable them could result in a serious injury as a result of an inadvertent discharge of the coil. 2. If the Magstim has not been triggered for over 1 minute after the READY symbol is illuminated the unit will automatically select the default mode and discharge internally. 3. Ensure the Stimulating Coil is functioning properly before proceeding. 4. As soon as the coil surface temperature rises to greater than 41 o C, in the case of the double 70mm Coil, or 50 o C in the case of the 90mm Coil, the stimulator will automatically select the default mode and discharge internally and the over-temp indicator ( item 3, shown in Section 4 of this Operating Manual) will illuminate. The stimulator cannot be re-armed until either the coil has cooled down, or is replaced with another cooler coil. The Magstim Company Limited th April 2005

13 3.4 Double 70mm Air-Cooled Coil Operation (instructions relate to use with a Magstim Rapid 2 ) 1. Connect the Coil to the main Rapid 2 Unit, and the Vacuum Unit NB the Vacuum Unit requires its own individual 10A - 115V, 5A - 230V power outlet. Switch on both units. The system status window will display ARMED and the instrument will charge to the level displayed on the POWER DISPLAY WINDOW. 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. Ensure that the air-extraction tubing is not in a position where it could be tripped over. 3. Press and hold down one or both of the safety switches located on the handle of the Stimulating Coil. Triggering the Rapid 2 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 2 will not trigger if the switch/es are not pressed, unless the coil switch over-ride option has been selected see Magstim Rapid 2 Operating Manual for further details. Safety Switch 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 Rapid 2 can be triggered once again in the normal manner. 5. When the tests have been completed, press the STOP switch on the UI of the Magstim Rapid 2. The Rapid 2 will then revert to STANDBY mode and cannot be triggered until it is armed once more. IMPORTANT On no account must the safety interlock switches and the enable button on the stimulator be permanently activated, by taping down, or any other method of fixing. They are designed as safety interlock switches, to disable them could result in a serious injury as a result of an inadvertent discharge of the coil. The Vacuum Unit is supplied as a dedicated unit. On no account should it be used for anything other than the cooling of the coil. To do so would clog the internal filters of the unit and result in impaired airflow 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. The Magstim Company Limited th April 2005

14 3.5 2 nd Generation Coil Extension Cable Operation (instructions relate to use with a Magstim 200 2, BiStim 2 and Rapid 2 ). Ensure that the locating spot on the coil plug is correctly lined up with the COIL OUTPUT SOCKET, located on the front panel of the Magstim Magnetic Stimulator. Insert the connector of the stimulating coil into the output socket. When the coil plug is fully engaged in the socket, lock the plug in place by turning the black locking ring clockwise until it clicks into place. It is important that the plug is connected correctly, with all sections of the locking ring mated. If the coil connector is connected at an angle, with one of the sections not correctly mated, permanent damage can be caused to the both the Cable and the Stimulator. The Magstim Company Limited th April 2005

15 3.6 Coil Adapter Operation (instructions relate to use with a Magstim 200 2, BiStim 2 and Rapid 2 ) Coil Adapter Plug Connect the Coil Adapter plug to the Magstim /Rapid 2 Coil Socket. Coil Adapter Socket Connect the Original, or Custom, Magstim Stimulating Coil to the Coil Adapter Socket, 1. Connect the Original, or Custom, Magstim Stimulating Coil to the socket section of the Coil Adapter, ensuring that the connector is fully mated and the metal locking ring fully engaged. 2. Connect the plug section of the Coil Adapter to the main Magstim unit as follows: Ensure that the locating spot on the Coil Adapter plug is correctly lined up with the COIL OUTPUT SOCKET, located on the front panel of the Magstim Model /Rapid 2. Insert the plug of the Coil Adapter into the output socket. When the plug is fully engaged in the socket, lock it in place by turning the black locking ring clockwise until it clicks into place. 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 Control Unit of the Magstim to arm the unit. The Magstim will charge and the READY indicator will be illuminated. 3. Position the Stimulating Coil on the desired area to be stimulated. Depress the footswitch, hold the Stimulating Coil and press and hold down one, or The Magstim Company Limited th April 2005

16 both, of the Trigger Enable switches on the Stimulating Coil. Press and hold the TRIGGER key on the Control Unit of the Magstim. There should be a clicking noise emanating from both the stimulating coil and the Magstim, each time the Magstim is discharged, indicating that a magnetic pulse is being delivered by the Stimulating Coil, stimulating the nerves beneath it. 4. 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 have recharged and can be triggered once again in the normal manner. 5. When the stimulations have been completed, press the STOP switch on the Control Unit of the Magstim. Note 1. A magnetic pulse will only be produced if one or both of the safety switches at the base of the stimulating coil are pressed. On no account must the trigger and enable buttons on the stimulating coil be permanently activated, by taping down, or any other method of fixing. They are designed as a safety interlock, to disable them could result in a serious injury as a result of an inadvertent discharge of the coil. 2. If the instrument has not been triggered for over 1 minute after the READY symbol is illuminated the unit will automatically select the default mode and discharge internally. 3. Ensure the Coil Adapter, and Stimulating Coil are functioning properly before proceeding. Error Codes The Magstim Model /Rapid 2 will display the appropriate error code on its display. The faults, and associated error codes, relating to the operation of the Coil Adapter are listed below. The error codes for faults relating directly to the operation of the stimulating coil are listed in section 6 of the Magstim Model Operating Manual and in section 8 of the Magstim Rapid 2 Operating Manual. C25 C26 EMC Detected (Coil adapter only). Invalid Coil Power Identification (Coil adapter only). The Magstim Company Limited th April 2005

17 SECTION 4: COIL DETAILS 4.1 Standard Coils 90mm Stimulating Coil Double 70mm Stimulating Coil COIL TRIGGER ENABLE Button (1) There is a COIL TRIGGER ENABLE button located on each side of the coil in the position indicated by the above photograph. The button is a safety feature, designed to prevent the stimulating coil from being inadvertently discharged. The Magstim Company Limited th April 2005

18 To enable the Magstim to be triggered, one, of both, of the trigger enable buttons must be depressed. COIL OVER-TEMPERATURE Symbol (2) READY Symbol (7) 4.2 Remote Control Coils This symbol is illuminated when the surface temperature has risen to 41 o C, in the case of the double 70mm Coil, or 50 o C in the case of the 90mm Coil If this symbol is illuminated the Stimulator will be put into its safe inactive default condition. This symbol is illuminated when the Magstim Model is charged and ready to be triggered. A magnetic pulse can be produced by depressing the second ARM/TRIGGER button, whilst continuing to hold the first ARM/TRIGGER button. 90mm Stimulating Coil NB All controls shown above are duplicated on the reverse side of the coil. The Magstim Company Limited th April 2005

19 Double 70mm Stimulating Coil Rear View of Coil Front View of Coil ARM/TRIGGER button (1) STOP Button (2) There is an ARM /TRIGGER button located on each side of the stimulating coil. One of the two buttons must be depressed, and held in that position, in order to arm the Magstim Model Stimulator. When the Magstim has charged to the set power level, it can be triggered by depressing the second ARM/TRIGGER button. The Magstim will continuously charge and discharge if the second ARM/TRIGGER button is depressed and held. The Magstim Model can be put into the safe inactive default mode by momentarily pushing the STOP button. The Magstim will then discharge internally. Note: The default mode is automatically selected if the coil is disconnected, becomes faulty, or the coil surface temperature rises to greater than 41 o C, in the case of the double 70mm Coil, or 50 o C in the case of the 90mm Coil, the Stimulator detects an internal fault, or if the READY symbol has been illuminated for over 1 minute without the Stimulator having been triggered. COIL OVER-TEMPERATURE Symbol (3) This symbol is illuminated when the surface temperature has risen to 41 o C, in the case of the double 70mm Coil, or 50 o C in the case of the 90mm Coil If this symbol is illuminated the Stimulator will be put into its safe inactive default condition. The Magstim Company Limited th April 2005

20 POWER UP Button (4) Individual presses of the button will increment the power level by 1%. If the button is pressed and held, the power level will continue to increase in 1% steps until the button is released, or the power level reaches 100%. When the button has been depressed for a count of 3, the rate of increase of power level will approximately double. OUTPUT % DISPLAY Indicator (5) This display is used to show the following: 1. The set power output as a percentage of maximum. After turning the Magstim Model on the OUTPUT % DISPLAY on the Remote Control 90mm Coil will display 30%. The POWER UP and POWER DOWN buttons can then be used to change the output level in 1% steps. Note: The OUTPUT % DISPLAY only shows the level the Magstim Model is actually charged to if the READY symbol (7) is illuminated. 2. The system status codes. See Section 5 of this Operating Manual. NB This manual assumes that the Remote Control is being used with a basic Magstim unit with no UI Controller. All error codes relating to the operation of the UI Controller are detailed in the Magstim Operating Manual POWER DOWN Button (6) READY Symbol (7) Individual presses of the button will decrement the power level by 1%. If the button is pressed and held, the power level will continue to decrease in 1% steps until the button is released, or the power level reaches 0%. When the button has been depressed for a count of 3, the rate of decrease of power level will approximately double. This symbol is illuminated when the Magstim Model is charged and ready to be triggered. A magnetic pulse can be produced by depressing the second ARM/TRIGGER button, whilst continuing to hold the first ARM/TRIGGER button. The Magstim Company Limited th April 2005

21 4.3 Air-Cooled Coils 2 nd Generation Air-Cooled Double 70mm Coil System The Magstim 2 nd Generation Air-Cooled Double 70mm Coil System comprises:- Air-Cooled Double 70mm Stimulating Coil , Coil Stand and Vacuum Unit Screw connector here Position the coil handle into the hook of the coil stand 1. Connect black hose to air extraction unit COIL TRIGGER ENABLE Button (1) There is a COIL TRIGGER ENABLE button located on each side of the coil in the position indicated by the above photograph. The button is a safety feature, designed to prevent the stimulating coil from being inadvertently discharged. To enable the Magstim to be triggered, one, of both, of the trigger enable buttons must be depressed. The Magstim Company Limited th April 2005

22 Magstim 2nd Generation Coils & Accessories SECTION 5: MAINTENANCE 5.1 USER MAINTENANCE At the start of each session the Operator must check the Stimulating Coils and Accessories for any signs of external damage. If any cracks are visible in the head enclosure, housing, plug or socket, or the cable insulation is compromised; the item must not be used and should be returned for servicing and repairs. In addition, when using the Double 70mm Air-Cooled Coil, the cooling system tubing must be checked for signs of damage/ breached insulation and the filters must be checked to ensure that they are not soiled. If the coil is used with soiled filters the cooling performance will be reduced. 5.2 TECHNICAL MAINTENANCE The plug and socket pins should be checked carefully, at the start of each day s operation, 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. Note: The pin burning is communicable - any item 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 an item with burnt pins connected to it will have its pins damaged immediately. If damage is noticed on any connecting plug or 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. The Magstim Company Limited th April 2005

23 Filter Changing (Air-Cooled Double 70mm Coil only) 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. Filter Change Instructions 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. Disposal of used filters The filters may be disposed of in the general waste disposal unit. There are no special conditions of disposal required. See Appendix for Coil Filter Change Record. 5.3 CLEANING AND DISINFECTING The Stimulating Coils, and Vacuum Unit, may be cleaned using an isopropyl alcohol moistened cloth. Ensure that the stimulating coils, and Vacuum Unit, have dried thoroughly before use. Note: The coils cannot be sterilised. Do not allow the coils, or Vacuum Unit, to become contaminated with bodily fluids. The Magstim Company Limited th April 2005

24 5.4 SERVICING The Stimulating Coils must be returned immediately to the Magstim Company Ltd., if there are any signs of external damage. All coil Servicing must be carried out by the Magstim Company Service Department only. 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: 5.5 DEVICE LIFETIME The Magstim Company Limited Spring Gardens Whitland Carmarthenshire SA34 0HR Wales United Kingdom Tel: +44 (0) Fax: +44 (0) Website: The lifetime of the Magstim Stimulating Coils and Accessories is defined as being 2 years from the date of shipment, with the exception of the Coil Adapter, whose lifetime is defined as being 5 years from the date of shipment. The Magstim Company Ltd. will support the products for the duration of their lifetime. 5.6 DISPOSAL When a Magstim Stimulating Coil, or Accessory, reaches the end of its serviceable life, the Magstim Company Limited should be contacted, at the above address, to arrange for its disposal in compliance with the appropriate environmental regulations. The Magstim Company Limited th April 2005

25 SECTION 6: SPECIFICATIONS GENERAL SPECIFICATIONS When used with a Magstim Magnetic Stimulator, the whole system is classified as Class 1. The Stimulating Coils and Accessories are classified as type BF applied parts when used with the Magnetic Stimulator. This means that their external surfaces are electrically isolated from the other parts of the equipment as required by safety standards of BSEN , with the exception of the Vacuum Unit, which 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 Stimulating Coils and Accessories comply with the requirements of the Safety Standard EN (90), including amendment 1 (91) and amendment 2 (95), and EMC Standard EN , with the exception of the Vacuum Unit, see above. Protection against ingress of liquids - The Stimulating Coils and Accessories 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 Stimulating Coils 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 Magnetic Stimulators, Stimulating Coils and Accessories, should not be used in the vicinity of any equipment that does not comply with EMC Standard EN , including mobile phones. The following relates to the Double 70mm Air-Cooled Coil ( ) only. a. If exposed to Radiated RF Immunity EN MHz 2.5GHz 2Hz 80% amplitude modulation the Cooled Coil System may produce system errors setting system into safe mode between 80MHz and 100MHz. b. If subjected to Conducted RF Immunity EN MHz 80MHz 2Hz 80% amplitude modulation the Cooled Coil System may produce system errors setting system into safe mode between 30MHz and 80MHz. For full information on EMC Emissions and Immunity in relation to the use of the 2 nd Generation Double 70mm Air-Cooled Coil System with the Rapid 2 System, see section 13 of the Rapid 2 Operating Manual. The Magstim Company Limited th April 2005

26 TECHNICAL SPECIFICATIONS Coil Average Inductance Max. rate of change of magnetic field Max. No. of Stimulations at 50% Power Max. No. of Stimulations at 80% Power Max. No. of Stimulations at 100% Power Weight 90mm Coils & Double 70mm Coils & Double 70mm Air-Cooled Coil Coil Adapter µH 22.5 x 10 3 T/s kg 15.50µH 25 x 10 3 T/s kg Max. magnetic field 0.93T 15.50µH See tables See tables See tables 3.9kg below below below kg The above Coils are fitted with a 2m cable as standard, with the exception of the Double 70mm Air-Cooled Coil, whose overall length is 4.5m and the Coil Adapter, whose length is 1m. The "maximum number of stimulations" columns relate to the number of stimulations that can be achieved with a Magstim 200 2, at an ambient temperature of 20 o C, before the coil exceeds its permitted operating temperature. The following data for the Double 70mm Air-Cooled Coil was obtained at an ambient temperature of 26 o C. Protocol 1: 10 second train at a frequency of 10Hz,with a 50 second inter-train interval Power Level No. of Trains 50% > 60 80% > % > 60 Protocol 2: 5 second train at a frequency of 25Hz, with a 26 second inter-train interval Power Level No. of Trains 50% > 30 80% % 4 Protocol 3: continuous single shot at a frequency of 1Hz Power Level No. of trains 50% > % > % > 3600 The Magstim Company Limited th April 2005

27 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 th April 2005

28 APPENDIX A Error codes produced by Coil. Error Codes Description C01 ROM Checksum Incorrect. C02 EEPROM Checksum Incorrect. C03 Invalid coil Category. C04 Invalid Power Identification. C05 Temperature sensor circuit failure. C06 Bad Serial command or received data checksum. C07 Internal Software Error. C08 Invalid Coil Temperature ID. C09 C10 C21 C22 C23 C24 C27 C28 C29 C30 Invalid temperature algorithm coefficient. Coil controller malfunction. Coil Disconnected/ Coil Under Temperature. Brown Out Detected. No serial Communications. Bad Serial command of received data checksum (outside TRIGGATE). Hardware Stop activated. Watchdog Timeout. Temperature Interlock 3 activation. Coil stop line fault. Error codes produced by base system. Codes E61 E62 E63 E64 E65 E66 Error Description Power fail Stack underflow Stack overflow RTS overrun WD Timeout Unexpected reset The Magstim Company Limited th April 2005

29 E67 E68 E70 E71 E72 E73 E74 E75 E76 E77 E78 E79 E80 E81 E82 E83 E84 E85 E86 E87 E88 E89 E90 Bad checksum SYS debug error Coil under temperature Coil max difference Stack over temperature Stack under temperature Stack max difference HVCAP over temperature HV Transformer over temperature Charge threshold failure VREF check failure HVCAP voltage comparison failure Charging fault HV over voltage Invalid system configuration Stop line fault Base coil stop line fault UI stop line fault Dump system fault WARNING high voltage may be present up to 20 minutes after use on internal high voltage capacitor. Invalid coil category for current system configuration. Invalid NVRAM Checksum. Faulty charging relay detected Base arm LED drive failure The Magstim Company Limited th April 2005

30 APPENDIX B Air-Cooled Coil Filter Change Record Filter changed by: Reason for change: Name: Signature: Date:.. Filter changed by: Reason for change: Name: Signature: Date:.. Filter changed by: Reason for change: Name: Signature: Date:.. Filter changed by: Reason for change: Name: Signature: Date:.. The Magstim Company Limited th April 2005

31 Cooled Coil Operation Record Operators Name Date Hours of Use Total Hours of Use Since Filter Change Signature The Magstim Company Limited th April 2005