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MAGSTIM ® RAPID

1. A gt Repetitive Session Press the Amplitude Cursors button green when selected to access the Amplitude Cursors panel Status Select the Status window to turn the Amplitude Cursors on and off The default setting is OFF Trace 1 This window allows the Amplitude Cursor on Trace 1 to be moved for example to mark peaks Trace 2 This window allows the Amplitude Cursor on Trace 2 to be moved for example to mark peaks Each time a new set of MEP waveforms are displayed and the Amplitude Cursors are active the cursors will automatically move to the peak values for each trace In Repetitive Mode or Session Mode the peak achieved in Single Pulse Mode will remain marked by the Amplitude Cursor on the trace The MAGSTIM Company LTD 18 November 2009 Magstim Rapid 3576 23 09 DISPLAY PANEL Channel 1 Display Channel 1 f Paramet Channel 2 Cursors f X Amplitude Coil Status Cursors f System Status Channel 2 Repetitive Session Press the Display button green when selected to access the Display panel Channel 1 Select the Channel 1 window to show Channel 1 only in the trace window Channel 2 Select the Channel 2 window to show Channel 2 only in the trace window Both Select the Both window to show both traces simultaneously in the trace window SAVE TRACES Select Save Traces to save the current trace If a file is alre
2. SS SS SS SS Se SS SS SS SS TO CREATE A FILE Go to File Maintenance Press the Local Store panel to select a black line appears around the panel Press New In the Local Store an arrow will point to a blank line Enter the new file name using the on screen keyboard Press Save on the Keyboard Make sure that the Local Store Screen is selected use the Rotary control knob to move the arrow to point to a new file name Press Open then Patient Details The File name will appear in the top right hand corner Select the required windows and enter details using the on screen keyboard Press Save on the Keyboard when the information is complete Press File to return to File Maintenance Press Close TO VIEW A FILE In file Maintenance select the Local Store Window Use the Rotary Control Knob to select a file Press View then Patient Details Press File to return to File Maintenance TO OPEN AND EDIT A FILE Select the Local Store Panel in File Maintenance Use the Rotary Control Knob to select a file Press Open then Patient Details Select the required window and make changes using the on screen keyboard Press Save on the keyboard to confirm Press File to return to File Maintenance Press Close The MAGSTIM Company LTD 32 November 2009 Magstim Rapid 3576 23 09 TO RENAME FILE e Select the File in the Local Store panel using the Rotary Control Knob e Press rename
3. 10 in steps of 1 This gives the user the choice to use the coil safety switch or not each time the system is armed When ON the System will prompt the user on a Run Screen to state if they wish to use the coil safety switch Note If the coil switch option is set to ON each time the system is armed the user will have a YES NO option on the screen to ignore the switches before the system can fire When the YES button is selected a small yellow button will appear in the top right hand corner of the system status panel to indicate ignore option is active It is important that those in the vicinity of the system are made aware that the system 1s in this mode of operation to ensure that inadvertent triggering does not occur Use Modify to alter the Date Settings Use Modify to alter the Date Settings To change the date and the time settings select the Modify button Individual windows appear to allow date month year hour minute and second to be altered Press to select a window and alter the information using the Rotary Control Knob To save press the Set Time button This option allows the user to change the language of the displays German English and French are available English is the Default language This window displays the UI s backup battery voltage Selection of this option takes you back to Systems Options Menu Selection of this option will return the user to the Options Menu Scre
4. Aux 5V 23 N C 11 Aux GND 24 Trigger Edge 12 N C 25 N C 13 N C 26 N C 7 3 SD CARD FILE DETAILS e General Each line of the file starts with a text string that describes the data that follows on that line Each line of data ends with a carriage return line feed request lt CR gt e File Layout The following details the order the data is stored in the Magstim UI generated file Version file format number lt CR gt File system filename CR Status system file status when exported CR File Time seconds minutes hours day month year CR Name patient name gt lt CR gt Sex patient sex CR ID patient ID gt lt CR gt Date or birth lt patient date of birth gt lt CR gt Protocol description lt patient protocol description text string gt lt CR gt Comments lt patient comments string gt lt CR gt Train lt power gt lt frequency gt lt duration gt lt number of pulses gt lt wait time gt lt number of trains gt lt CR gt Burst lt power gt lt frequency gt lt number of pulses gt lt burst frequency gt lt number of bursts gt lt cycle time number of cycles gt lt CR gt see notel Session 1 start time lt power gt lt frequency gt duration number of pulses wait time CR Session 2 start time lt power gt lt frequency gt duration number of pulses wait time
5. Care should be exercised when placing surface electrodes It is important that a consistent approach is observed as the amplitude of the EMG signal is dependent on the position of the electrodes Good practice in relation to skin cleaning should be observed CAUTION For safety reasons do not leave patient cables attached to the MEP Pod if they are not being used If an unused cable is left connected and the patient is connected to the other channel there is the possibility that the unused cable may touch an earthed surface which could allow current to flow through the patient to ground Do not allow the coil or the coil cable to come into close proximity with the MEP Pod patient cables During discharge current may be induced in these cables The MAGSTIM Company LTD 8 November 2009 Magstim Rapid 3576 23 09 3 5 PRINTER TO SET UP THE PRINTER 1 Insert the cable connector straight into the Printers Serial Port to power the printer via the Mains Serial Port 2 Connect the other end of the cable to the back of the UI via an optical RS 232 Interface cable by sliding the connector into the slot until tight Connect the printer to its power supply and the power supply to the mains Optical RS 232 Interface cable 3 Switch the printer on via the green button on the left hand side of the printer The Power LED should now be illuminated green TO LOAD THE PAPER 1 Push the Cover Open buttons on the side of the printer t
6. at a resolution of 1 Frequency 1 100 Hz at a resolution of 1Hz Note the settable power to frequency values is determined by the system configuration see user manual for Rapid system for more details Duration 0 1 10 0 seconds at a resolution of 0 1 seconds umber of pulses 1 1000 at a resolution of 1 Wait time 1 0 60 0 seconds at a resolution of 0 1 seconds Number of trains 1 250 at a resolution of 1 Note all time periods are specified in multiples of tenths of a second i e if a time period of 6 5 seconds is required then a value of 65 is entered between the commas Z Burst This line contains the parameters displayed on the repetitive set up screen on the UI Burst mode The individual parameter value ranges are as follows Power 0 100 at a resolution of 1 Frequency 1 100 Hz at a resolution of 1Hz Note the settable power to frequency values is determined by the system configuration see user manual for Rapid system for more details Number of pulses 1 10 at a resolution of 1 Burst frequency 1 10 Hz at a resolution of 1Hz Number of bursts 1 500 at a resolution of 1 Cycle time 1 0 500 0 seconds at a resolution of 0 1 seconds Number of cycles 1 250 at a resolution of 1 Note all time periods are specified in multiples of tenths of a second i e if a time period of 6 5 seconds is required then a value of 65 is entered between the commas Session x These lines co
7. panel Select a file by turning the Rotary Control Knob until the arrow points at the chosen file Press the Export Button The screen will display the command Please wait Data Transfer in Progress the file will appear in the Memory Card store panel The file is now saved onto the SD Card The UI only supports the short DOS file name convention of 8 characters for the file name and 3 characters for the file extension when reading from or writing to the SD Card Long file names on the UI will automatically be reduced down to 8 letters for export purposes onto the card All Files exported from the UI onto the card will have the file extension MRF When the file is returned to the UI via the SD Card its original file name will be displayed See section 7 3 for saved data format The Rapid is only compatible FAT 16 formatted SD cards The UI can only be used to read or to write a file from the card It can not format create directories or delete any data stored on the card FORMATTING AN SD CARD WITH A PC Make sure an SD Card Reader is connected to the system Insert the SD card Using Windows Explorer select the drive associated with the SD card Select the Format option Under File System select the FAT option Follow the instructions on screen The MAGSTIM Company LTD 34 November 2009 Magstim Rapid 3576 23 09 6 5 PRINT OPTIONS The printer makes it possible to generate copies of the majority of the inf
8. 10A Link Lead 1 x HV Cable 1 x UI Cable 1 x Rapid UI Printer Package 1 x Magstim SD Card Additional Items Available Trigger Input Output Cable MEP Pod EMG cable HP90 Coil Standard HP90 Coil Double Double 70mm Coil 2 Generation Double 70mm Coil The MAGSTIM Company LTD 58 P N 3004 00 N 3012 00 N 3013 00 N 3022 00 N 9525 01 N 3110 00 N 3526 00 N 3719 01 N 3726 01 N 3764 01 N 3801 01 N 600002 N 3583 00 N 3582 00 N 3804 00 P N 3005 00 N 3012 00 N 3014 00 N 3022 00 N 9525 01 N 3110 00 N 3526 00 N 3719 01 N 3726 01 N 3764 01 N 3801 01 N 600002 N 3583 00 N 3582 00 N 3804 00 N 3844 00 Y YYYY YYYY Available to Order Available to Order Available to Order Available to Order P N 9925 00 P N 3191 00 November 2009
9. CR Session 30 start time lt power gt lt frequency gt duration number of pulses wait time lt CR gt 0 Trace 1 Trace 2 lt gt MEP 1 reading 1 tracel gt reading 1 trace2 gt lt CR gt 2 reading 2 tracel gt reading 2 trace2 gt lt CR gt 3 reading 3 tracel gt reading 3 trace2 gt CR 4 reading 4 gt reading 4 trace2 gt CR 300 reading 300 tracel gt reading 300 trace2 gt lt CR gt MEP Configuration time base index gt channel voltage range index gt channel 2 voltage range index gt special feature filters index CR The MAGSTIM Company LTD 39 November 2009 Magstim Rapid 3576 23 09 Note 1 Line only added to files by UI software version V6 0 or greater e File line Details The following details the content and data range limits for each data lines contained in the Magstim UI generated file Version This number is created by the UI and must be present in the file and must not be altered An invalid number will result in the file not being imported correctly File This is the file name used the UI and must contain at least one character and not more than 18 characters The file name can contain any standard alphanumeric character except a comma Status This number is used by the UI to determine what state the file was in when it was exported and must not be altered An
10. Magstim Company Ltd or one of its authorised service centres It is recommended that an annual PAT Portable Appliance Test test be carried out on the Magstim Rapid For further information or service contact The Magstim Company Limited Spring Gardens Whitland Carmarthenshire SA34 0HR Wales United Kingdom Tel 44 0 1994 242900 Fax 44 0 1994 242910 email service magstim com Website www magstim com Important The Rapid PSU and UI contain circuitry that is at mains HV potential during operation Some HV hazardous potentials will continue to be present for some time after the system has stopped operating Therefore under no circumstances must un authorised persons remove the screws securing the covers of the Magstim Rapid PSU or UI In addition to the risk of electric shock removal of any of the system covers will automatically render the guarantee void Service training courses are available on request For further information contact the Magstim Company Service Manager The MAGSTIM Company LTD 45 November 2009 Magstim Rapid 3576 23 09 PACKING INSTRUCTIONS If for any reason it is necessary to return your Rapid System to either the Magstim Company or local Distributor for repair or upgrade care should be taken to ensure that the equipment is adequately packed to prevent transit damage Ideally the equipment should be returned in its original packing Ifthis or an adequate replacem
11. Number of Trains f al Number of Pulses f 207 Mait Time f 1 059 Total Number of Pulses f 20 Duration f 2 0s Power f 1 Frequency f 104 Standard Burst Options Menu Save Sessi on Run Sessi on Select the power window and use the Rotary Control Knob to adjust the System Power Level The power can be increased or decreased in 1 increments Selecting the Frequency window allows the user to set the frequency of the pulses to a value between 0 and increments The maximum frequency can be up to 100Hz depending on the power level set and the system configuration A table detailing the available power frequency combinations is included in Section 10 Selecting the Duration window allows the user to set the duration of the pulse train to between 0 1 and 10 seconds in 0 1 second increments On entering the duration and frequency the number of pulses is automatically calculated by the UI and displayed Selecting the Number of Pulses window allows the user to set the number of pulses in a train to between 1 and 1000 in steps of 1 The number of pulses cannot be set to deliver more than 10 seconds stimulation If the frequency is altered the system will automatically adjust the duration to fit the current number of pulses Selecting the Wait Time allows the user to set the wait time to between 1 and 60 seconds in 0 1 second steps However if the minimum wait time re
12. Rapid System must be used only with those parts specified by the Magstim Company Ltd for use with the Magstim Rapid System Voltage 115V 10 AC 60Hz 230V 10 AC 50Hz 240V 10 AC 60Hz Power Input Fuse Rating 1 25A T x2 Equipment should be used with the line cord provided Where a fused line cord is used the appropriate fuse should be fitted Maximum Power Requirements 230V 240V Rapid Systems 20VA Standby Option 1 During Discharge Option 2 6kVA 115V Rapid Systems 20VA Standby Option 1 2 3kVA During Discharge Option 2 4 6kVA The MAGSTIM Company LTD 47 November 2009 Magstim Rapid 3576 23 09 MEP Pod Class Type Class 1 BF Channels 2 CMMR gt 90dB Dynamic Range 30mV 10 Amplitude accuracy 10 at gt full scale Display resolution lt 2 Cursor resolution lt 2 Timebase accuracy lt 1 of sample period Timebase resolution 0 33 of sample period CALIBRATION Calibration is not required 10 3 AMBIENT TEMPERATURE Permissible Environment Conditions for Transport Ambient Temperature Range 19 C to 60 C Relative Humidity Range 10 to 80 Non Condensing Atmosphere Pressure Range 50kPa to 106kPa Storage and Operating Conditions Operating Temperature Range 5 C to 40 C Storage Temperature Range 19 C to 60 C Coil Temperature Range 5 C to 40 C 10 4 CAPACITOR LIFE EXPECTANCY Life expectancy 2 x 10 discharges at 70 power level 8 x 10 discharges a
13. and use the on screen keyboard to make changes e Press Save on the keyboard to confirm TO DELETE A FILE e Select the file in the Local Store panel using the Rotary Control Knob e Press Delete e on screen prompt will ask Are you sure you wish to delete selected file e Press Yes or TO MANAGE FILES FROM SINGLE PULSE MODE REPETITIVE MODE AND SESSION MODE To save settings created in for example Single Pulse Mode go to File Maintenance Press New Select the Local Store Panel and add the new file name using the keyboard Press Save on the keyboard Move the arrow to the new file name using the Rotary Control Knob Press Save As The prompt Are you sure you wish to overwrite the selected file will appear whether the file currently contains information or not Select Yes e Use the on screen buttons to navigate back to for example Single Pulse Mode The MAGSTIM Company LTD 33 November 2009 Magstim Rapid 3576 23 09 6 4 SD CARD An SD Card provides the opportunity for information that is stored on the Magstim Rapid to be transferred to a PC and viewed using any standard PC text editing software package Information is transferred onto the SD Card via the File Maintenance Screen To save a stored file onto an SD Card insert the SD Card into the socket situated on the side of the UI see Section 3 Select the File Maintenance screen and select the Local Store
14. lower leg height Mid lower leg height Women Men The MAGSTIM Company LTD 54 November 2009 Magstim Rapid 3576 23 09 SECTION 11 EMC EMISSIONS AND IMMUNITY Guidance and Manufacturer s Declaration Electromagnetic Emissions The Magstim Rapid System is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions Group 1 The Magstim Rapid System must emit electromagnetic energy in 55011 order to perform its intended function Nearby electronic equipment may be affected The Magstim Rapid System is suitable for use in all establishments RF emissions Class A other than domestic and those directly connected to the public low 55011 voltage power supply network that supplies buildings used for domestic purposes Harmonic Class A Emissions by equipment IEC 61000 3 2 type Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Magstim Rapid System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Magstim Rapid System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF commun
15. 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 Coil may 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 UI indicates that the coil is over temperature If the Rapid system is externally triggered via a signal generator the coil temperature algorithm is disabled Under this condition at high frequency high power it is possible for the coil temperature to reach levels well in excess of the 41 C limit specified in EN60601 1 before the hardware temperature cut out operates If the system is to be used under these conditions it is essential that the intended protocol be run prior to use on a patient to ensure that its temperature remains within the required limit 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 Magstim Rapid and its accessories be used in environmental conditions outside those specified in
16. servicing to qualified personnel Ensure that the System is not subject to conditions where water liquid may be tipped on it including the UI Controller To ensure grounding safety all mains power connections should be made directly to wall power outlet sockets All of the customer s electrical cabling must conform to local electrical standards Do not use a terminal block if insufficient sockets are available as this will form a potential electrical hazard The Magstim Rapid its stimulating coil 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 The MAGSTIM Company LTD 1 November 2009 Magstim Rapid Coil Over Temperature 3576 23 09 Do not discharge the Stimulating Coil in the vicinity of objects sensitive to magnetic fields Examples are credit cards floppy disks and computer screens Protection circuits disable the equipment if the temperature of the Stimulating Coil exceeds 40 C Coils must not be immersed in water put in an ice bucket or refrigerated even if placed within a plastic bag as condensation may be created within the coil 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
17. that the Magstim Rapid System be powered from an interruptible power supply Power Frequency 50 60 2 Magnetic Field IEC 61000 4 8 3 A m 50Hz Meets requirement Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Radiated RF 80MHz 2 5GHz Coil adapter P N Equipment should only be used in the Immunity 2Hz 80 amplitude 3110 00 and Cooled vicinity of other equipment compliant with EN61000 4 3 modulation Coil P N 3380 00 EN60601 1 2 between 80MHz and 100MHz may produce system errors setting system into safe mode Conducted RF 0 15MHz 80 2 Coil adapter P N Equipment should only be used in the Immunity 2Hz 80 amplitude 3110 00 and Cooled vicinity of other equipment compliant with EN61000 4 6 modulation Coil P N 3380 00 EN60601 1 2 between 30MHz and 80MHz may produce system errors setting system into safe mode NOTE Uz is the a c mains voltage prior to application of the test level The MAGSTIM Company LTD 56 November 2009 Magstim Rapid 3576 23 09 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Magstim Rapid System is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic environment guidance
18. the 230V units with the exception of Power Su l Module PSU 3013 00 the voltage power rating labels sited on the rear of the units The MAGSTIM Company LTD 6 November 2009 Magstim Rapid 3576 23 09 3 3 ADDITIONAL CONNECTIONS SD Card Printer Insertion Point TT Connection 15 Way D Type Connector 25 Way D Batteries Type Connector 26 Way D Type Connector 25 Way D Type Connector situated on rear of the UI 2 rows of pins This connector is situated on the rear of the UI and has 2 rows of pins The connector links the UI to the Magstim Rapid as shown on the diagram on the previous page 26 Way D Type Connector situated on rear of UI 3 rows of pins This connector is situated on the rear of the UI and has 3 rows of pins It provides trigger input and output signals see page 54 DC Power Jack situated on rear of UI The DC Power Jack is situated on the rear of the UI This connector allows an external 24V 750mA DC power supply to be attached A suitable medical grade supply must be used conforming to IEC 60601 1 This is NOT required when the UI is connected to the Magstim Rapid Printer which slides into place on the right hand side at the rear of the UI A 4 gt The Printer is attached to the User Interface via Optical RS232 Interface Cable SD Card Socket situated on rear of the left side panel connection of an SD Card This removable memor
19. when the system is armed and high voltages are present in the system This LED turns RED when a fault has been detected in the PSU Coil OUTPUT Socket Operation and SYMBOLS This socket is used to connect the stimulating coil to the Magstim Rapid Note that the unit cannot be armed and triggered unless the stimulating coil is connected to this output Ensure that the locating pin in the coil plug 18 correctly lined up with the coil output socket before inserting the plug When the coil plug is fully engaged in the socket lock the plug in place by turning the black locking ring clockwise To remove the coil put the Magstim Rapid into standby and turn the black locking ring anti clockwise AN HIGH VOLTAGE Symbol This sign warns that voltages in excess of 1500V are present within the instrument ATTENTION Symbol Consult Operating Manual See warnings in Section 1 regarding the use of the Magstim Rapid APPLIED PART Symbol BF Type Applied Part The MAGSTIM Company LTD 3 November 2009 Magstim Rapid 3576 23 09 The applied parts of this device namely the stimulating coil MEP Pod and MEP Pod patient leads are electrically isolated from the other parts of the equipment as required by the safety standards of BSEN60601 1 2 2 INDICATIONS The Rapid works by inducing electrical currents in tissue using a non invasive stimulating coil at frequencies of up to 100Hz The stimulating coil is placed near the intended site of stimu
20. 4 60 34 33 60 35 32 60 36 32 60 37 31 60 38 30 59 39 29 57 40 28 55 41 28 54 42 27 53 43 26 52 44 26 51 45 25 50 46 25 49 47 24 47 48 24 46 49 23 45 50 23 44 51 22 43 52 22 42 53 21 42 54 21 41 55 21 40 56 20 40 57 20 39 58 19 38 59 19 38 60 19 37 61 18 36 62 18 36 63 18 35 64 18 35 65 17 34 66 17 34 67 17 33 68 16 33 The MAGSTIM Company LTD 50 November 2009 Magstim Rapid 69 16 32 70 16 32 71 16 31 72 16 31 73 15 30 74 15 30 75 15 29 76 15 29 77 14 28 78 14 28 79 14 28 80 14 27 81 14 27 82 13 27 83 13 26 84 13 26 85 13 26 86 13 26 87 12 25 88 12 25 89 12 25 90 12 24 91 12 24 92 12 24 93 12 24 94 12 23 95 11 23 96 11 23 97 11 22 98 11 22 99 11 22 100 11 22 The MAGSTIM Company LTD November 2009 Magstim Rapid 10 6 COIL COMPATIBILITY 3576 23 09 Only standard production coils can be used with our Rapid Rate Stimulators unless a compatible custom coil with a high inductance is specifically made for the customer All coils to be used with a Rapid system must have an inductance of 15uH or more Low inductance coils are likely to damage the Rapid Rate Stimulator Only the Remote Control and 2 Generation Coils can be connected directly to the Rapid System other coils must be connected via Coil Adapter P N 3110 00 Coil Description 90mm Coil 90mm Remote Control
21. 48 November 2009 Magstim Rapid 3576 23 09 230V 240V Rapid Systems Available Output Power Operating Frequency Hz Max 100Hz Rapid Option 2 Rapid Option 1 0 30 100 50 31 98 46 32 95 45 33 93 44 34 90 42 35 88 41 36 85 41 37 83 39 38 80 39 39 78 38 40 75 37 41 73 36 42 70 34 43 68 33 44 65 33 45 63 33 46 60 33 47 58 33 48 55 32 49 53 31 50 50 30 51 50 30 52 49 29 53 49 29 54 48 28 55 48 28 56 47 27 57 47 27 58 46 26 59 46 26 60 45 25 61 45 25 62 44 24 63 44 24 64 43 23 65 43 23 66 42 22 67 42 22 68 41 21 69 41 21 70 40 20 71 40 20 72 39 20 73 39 20 74 38 19 75 38 19 76 37 19 77 37 19 78 36 19 79 36 18 80 35 18 81 35 18 82 34 18 83 34 18 84 33 18 85 33 17 86 32 17 87 32 17 The MAGSTIM Company LTD 49 November 2009 Magstim Rapid 3576 23 09 88 31 17 89 31 17 90 30 17 91 30 17 92 29 16 93 29 16 94 28 16 95 28 16 96 27 16 97 27 16 98 26 15 99 26 15 100 25 15 115V Rapid Systems Frequency Hz 60Hz Power 46 Rapid 3463 00 Super Rapid 3464 00 0 30 36 60 31 35 60 32 35 60 33 3
22. Coil Double 70mm Remote Control Coil Double 70mm 214 Generation Coil 2 Generation Double 70mm Cooled Coil Small 50mm Coil Medium 70mm Coil Large HP 90mm Coil Double 25mm Coil Double 70mm Cooled Coil Double 70mm Coil 110mm Double Cone Coil Part Number 3193 00 3192 00 3190 00 3191 00 3530 00 9999 00 9762 00 9784 00 1165 00 1640 00 9925 00 9902 00 Average Inductance 2347uH 2347uH 15 50uH 15 50uH 15 004H 13 504H 16 25uH 23 30uH 10 35uH 15 004H 16 35uH 17 85uH Use with Rapid System Compatible Compatible Compatible Compatible Compatible Not Compatible Compatible Compatible Not Compatible Not Compatible Compatible Compatible Coil Operating Duration at 20 C in Single Shot Mode using the Rapid System Coil Average Max No of Max No of Max No of Inductance Stimulations at Stimulations at Stimulations at 50 Power 80 Power 100 Power 90mm Coil 3192 00 3193 00 23 47uH 9277 420 311 Double 70mm Coil 3190 00 3191 00 15 50uH 638 264 212 HP 90mm 9784 00 23 30uH 1935 539 406 70mm 9762 00 16 254uH 428 282 155 Db 70mm 9925 00 16 35 1576 448 392 DC 110mm 9902 00 17 85 1419 806 406 The MAGSTIM Company LTD 52 November 2009 Magstim Rapid 10 7 UI REAR PANEL ISOLATED TRIGGER I O Port 3576 23 09 The maximum non destructive voltage that can be appl
23. Export allows the user to export the selected File name in the Local Store window to the multi media card See section 6 3 Import transfers the selected file from the multimedia card to the Local Store window For Print operations See Section 6 4 Selection of this option will call up the Patient Details Screen The MAGSTIM Company LTD 30 November 2009 Magstim Rapid 3576 23 09 Back Selection of this option returns the user to the previous screen Options Menu Selection of this option will return the user to the Options Menu Screen 6 2 PATIENT DETAILS Keyboard Save Name Sex IDs Date of Birth Protocol Description Comments Print Delete File Options Menu oo di Ee YS SS SS gt aw a a lo la eG Ge GG SS Se SS SS S amp S SS amp el Press File at any time to return to File Maintenance The Keyboard is touch sensitive To enter details into a field first select the required field window so that it becomes active showing a dark blue line around the window The Save key on the keyboard de selects the active window and saves the information is saved in the current window Press the window to select The Patient Name window can accept up to 40 characters Enter details using the on screen keyboard Press the window to select The Patient Sex window can accept only 1 c
24. It is therefore used to alter screen settings as well as changing the power output of the stimulator TOUCH SENSITIVE SCREEN SYSTEM DISPLAY selections are made via the touch screen To select touch the centre of the button symbol next to the desired menu option Do not press hard or use a sharp or pointed object to make the selection as this may damage the touch screen In the set up screens all selectable items are coloured in pale blue white items are non selectable The Rotary Control Knob can only be used to change parameters already selected Details regarding the contents and operation of the UI Screens are given in Sections 4 5 and 6 Note If the UI is not used for 30 minutes it will go into a standby condition In standby the screen will appear blank and the blue LED in the upper right corner of the front bezel will pulse Touch the screen to restore the UI The MAGSTIM Company LTD 11 November 2009 Magstim Rapid 3576 23 09 3 8 STIMULATION See Section 4 to select the desired mode stimulating power stimulation frequency train duration and inter train delay Activate the ARM button on the UI bezel to arm the unit The system will charge and the UI will display READY in the system status window NOTE The system cannot be armed if the footswitch 1s active Position the stimulating coil on the desired area of tissue The system can be triggered by pressing a coil switch button and either pressing the footswitch
25. MC Standard EN 60601 1 2 including mobile phones For reasons of safety and reliability 1f the system 1s set at 10096 power the user must not exceed 250 stimuli per minute or 4000 stimuli per hour or 24 000 stimuli for every 24 hour period This limitation is in addition to any other limitation imposed by the dedicated controller or heating effects on the stimulating coil and charger circuitry The entire Operating Manual should be studied prior to use and users should be aware in particular that high voltages and currents which can prove lethal are present if the covers are removed The Magstim Rapid system s parts are detailed in Sections 3 6 Each of the mains connections for the Rapid System must be made via separate permanent mains outlets On no account should a multi way extension lead be used to connect more than one mains connector to a single mains outlet The Rapid System must be used only with the supplied mains leads fitted with an integral filter as they are required to maintain the System s compliance with EN 60601 1 2 regarding Electro Magnetic emissions as is the earth strap fitted between the stimulator and the power supply unit PSU The MEP Pod is designed to be fitted to the Magstim Rapid UI only Do not attempt to connect it to a computer or any other equipment with a similar connector To do so could result in electric shock burns to the patient at the site of electrode attachment The MEP Pod con
26. Magstim Rapid 3576 23 09 MAGSTIMS RAPID P N 3576 23 09 OPERATING MANUAL The MAGSTIM Company LTD November 2009 Magstim Rapid TABLE OF CONTENTS Section 1 Warnings and Precautions Section 2 Product Description 2 1 Front View 2 2 Indications 2 3 Coils Section 3 System Setup 3 Rear View 3 2 PSU 3 3 Additional Connections 3 4 MEP Pod Connection 3 5 Printer 3 6 Set up 3 7 UI 3 8 Stimulation Section 4 System Operation Instructions 4 1 Welcome Screen 4 2 Main Options Menu 4 3 Single Pulse Mode 4 4 Single Pulse Mode MEP 4 5 Repetitive Mode Setup Standard 4 6 Repetitive Mode Standard 4 7 Repetitive Mode Setup Burst 4 8 Repetitive Mode Burst 4 9 Session Mode Setup 4 10 Session Mode Section 5 System 5 1 System Options Menu 5 2 User Configuration 5 3 System Details 5 4 System Configuration Section 6 Data Retrieval 6 1 File Maintenance 6 2 Patient Details 6 3 Creating and using Files 6 4 SD Card 6 5 Print Options Section 7 System Status Codes 7 1 System Status Codes 7 2 Isolated Trigger Port 7 3 SD Card File details Section 8 Safety Features 8 1 Coil Temperature Protection 8 2 Coil Disconnection Section 9 Maintenance and Servicing 9 1 Voltage Selection Instructions 9 2 User Maintenance 9 3 Technical Maintenance 9 4 Cleaning and Disinfecting 9 5 Servicing 9 6 Device Lifetime 9 7 Disposal Section 10 Specifications 0 1 General 0 2 Power 0 3 Ambient Temperature 0 4 Capacitor Life E
27. O Not Protected as there is no specialised protection provided against the ingress of liquids Not Protected Therefore the Magstim Rapid System and its accessories are not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide Continuous The Magstim Rapid System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment should be observed to verify normal operation in the configuration in which it will be used The Magstim Rapid System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in Section 11 of this Operating Manual NB When the system is exposed to radiated RF between 80MHz and 100MHz or conducted RF between 30MHz and 80MHz when used with Coil Adapter P N 3110 00 and Cooled Coil P N 3380 00 system errors may occur setting system into safe mode To avoid interference problems the Magstim Rapid System and its accessories should not be used in the vicinity of any equipment that does not comply with EMC Standard EN 60601 1 2 including portable and mobile RF communications equipment such as mobile phones The use of accessories transducers and cables other than those specified by the Magstim Company Ltd may result in increased emissions decreased immunity of the equipment In order to ensure EMC compliance the Magstim
28. Rapid 3576 23 09 SECTION 9 MAINTENANCE AND SERVICING 9 1 VOLTAGE SELECTION AND FUSE RATING The Magstim Rapid may be operated from supplies in the range of 115V 10 60Hz 230V 10 50Hz and 240V 10 60Hz The voltage selector on the rear panel and the adjacent fuses must correspond to the supply voltage as indicated in the table below The PSU however is not voltage selectable and is manufactured as either a 230V 240V 10 unit ora 115V 10 unit The two are not interchangeable Supply Voltage Set Voltage Quantity Fuse Rating Selector To 115V 10 60Hz 115V 2 1 25A T 230V 10 50Hz 230V 2 1 25A T 240V 10 60Hz 230V 2 1 25A T T denotes timed or antisurge fuses The use of fast acting fuses is not recommended VOLTAGE SELECTION INSTRUCTIONS IMPORTANT Ensure that the Magstim Rapid is disconnected from the mains supply before changing the fuse or setting the voltage selector CHANGING FUSE TYPE The MAGSTIM Company LTD Insert the tip of a small blade screwdriver or similar tool into slot no 2 shown in diagram above Gently lever up the retaining lip of the fuse holder The fuse holder will then slide out Using a pair of narrow nosed pliers grip the voltage selector unit on one of the metal connection plates and remove it from the Power Entry Module Orient the voltage selector unit such that the desired voltage is facing out from the Power Entry Module
29. Re insert the voltage selector unit into the Power Entry Module Replace the fuse holder ensuring that the retaining lip is properly home and verify that the voltage window 1 displays the correct voltage value Insert the tip of a small blade screwdriver or similar tool into slot no 2 shown in diagram on previous page Gently lever up the retaining lip of the fuse holder The fuse holder will then slide out Replace damaged fuse s with a suitable replacement Replace the fuse holder ensuring that the retaining lip is properly home 43 November 2009 Magstim Rapid 3576 23 09 9 2 USER MAINTENANCE At the start of each session the Operator must check the Magstim Rapid2 PSU UI and the stimulating coil for any signs of damage paying particular attention to the plastic casing If there are any signs of physical damage to the Magnetic Stimulator PSU UI or the stimulating coil they must not be used The cooling vents should also be checked to ensure that they have not become blocked or obstructed The UI contains 2 AA cell batteries These are not rechargeable and will need to be replaced if patient information is stored on the system It is important that regular checks are carried out to ensure that the batteries are replaced when necessary Failure to do so will result in the information being lost The Battery voltage can be viewed in the User Configuration Screen 9 3 TECHNICAL MAINTENANCE BACKUP BATTERIES Th
30. TIM Company LTD 15 November 2009 Magstim Rapid 3576 23 09 4 4 SINGLE PULSE MODE MEP POD CONNECTED The MEP Pod must be connected to access the following options and to view the traces NOTE The Rapid must be switched off before connecting or disconnecting the MEP Pod PARAMETERS PANEL Channel 1 MEP Configuration tne nse F208 s SION Volts div wur 20090 Channel 2 Voltsdiv Channel 2 Trace 2 Coil Status 2 Type 1 System Status X Repetitive Session Press the Parameters button green when selected to access the MEP Configuration panel Time Base Selecting the Time Base window allows the user to set the MEP total sample period The selectable options are 20ms 50ms 100ms 200ms and 500ms and are selected using the Rotary Control Knob The trace width will show the whole of the selected sample period Filters Selecting the Filters window allows the user to set the MEP Filter using the Rotary Control Knob Selectable options 2Hz 10kHz and 20Hz 10kHz Volts Div Trace1 Selecting the Volts Div Trace window allows the user to set the scaling factor for channel 1 Selectable options 50 100uV 200LV 500LV 2mV 5mV and 10mV The default setting is 200uV Volts Div Trace 2 Selecting the Volts Div Trace window allows the user to set the scaling factor for channel 2 Selectable options 50uV 100uV 200LV 500uV 2mV 5mV and 10mV The default setti
31. Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Magstim Rapid System including cables than the recommended separation distance calculated from the equation applicable to the frequency transmitter Recommended separation distance 3 5 1 VP Conducted RF 3 Vrms Vi V Vi IEC 61000 4 6 150 kHz to 80 MHz 35 80 MHz to 800 MHz d 4NP E Radiated RF 3 V m Ei V m IEC 61000 4 3 80 MHz to 2 5 GHz 722 800 212 5 GHz E Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field Strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 1 9 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagneti
32. ady open the trace will be saved to this file Alternatively go to File Maintenance and save the trace to a file See section 6 COIL STATUS PANEL The Coil Status panel will show the temperature and type of coil SYSTEM STATUS PANEL The System Status panel shows the system status WINDOW The Trace window will be updated when a stimulation occurs The maximum update rate for the trace window is 4 times a second depending on the amount of information to be displayed Print For Print operations see Section 6 Repetitive This takes the user to the Repetitive Setup Screen See Section 4 5 Session This takes the user to the Session Setup screen see Section 4 9 File This takes the user to the File Maintenance screen see Section 6 Options Menu Selection of this option will return the user to the Options Menu screen The MAGSTIM Company LTD 19 November 2009 Magstim Rapid 3576 23 09 4 5 REPETITIVE MODE STANDARD SETUP The Repetitive Setup Screen allows the user to set the following adjustable parameters to the desired values to enable a session to be run If Repetitive Setup is accessed from Single Pulse Mode the protocol intensity value established in Single Pulse Mode will be carried over into the power window Power Frequency Duration Number of Pulses Wait Time No of Trains Information Window Print Save Session Options Menu RUN SESSION The MAGSTIM Company LTD 20 magstim
33. c environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured filed strength in the location in which the Magstim Rapid System is used exceeds the applicable RF compliance level above the Magstim Rapid System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Magstim Rapid System Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m The MAGSTIM Company LTD 57 November 2009 Magstim Rapid 3576 23 09 SECTION 12 RAPID SYSTEM PACKAGES Option 1 Standard Rapid 1 x Rapid Main Frame 1 x Power Supply Single Module x User Interface UI 1 Footswitch 1 x Coil Adapter 1 x MEP Pod 1 x 230V UK Mains Lead with integral filter OR 1 x 230V European Mains Lead with integral filter OR 1 x 240V North American Lead with Integral filter OR 1 x 115V North American Lead with Integral filter 1 x 10A Link Lead 1 x HV Cable 1 x UI Cable 1 x Rapid UI Printer Package Option 2 Super Rapid 1 x Rapid Main Frame 1 x Power Supply Dual Module x User Interface UI 1 Footswitch 1 x Coil Adapter 1 MEP Pod 2 x 230V UK Mains Lead with integral filter OR 2 x 230V European Mains Lead with integral filter OR 2 x 240V North American Lead with Integral filter OR 2 x 115V North American Lead with Integral filter 1 x
34. ctions are made via the touch screen To select touch the centre of the button symbols Single Pulse Repetitive Mode Session Mode System File Maintenance Selecting this option will call up the Single Pulse Mode Screen This allows the system to be fired at a maximum rate of 1Hz up to 100 power and 0 5 Hz from 101 110 It also allows module to be configured Selecting this option will call up the Repetitive Mode Set up Screen See section 4 5 This allows the system to run a user defined train of pulses from a single trigger Selecting this option will call up the Session Mode Setup Screen See section 4 9 This allows the system to run a series of separately defined trains of pulses from a single trigger Selecting this option will call up the Systems Options Menu Screen See Section 5 Selecting this option will call up the File Maintenance Screen See section 6 The MAGSTIM Company LTD 14 November 2009 Magstim Rapid 3576 23 09 4 3 SINGLE PULSE MODE The trace window is always active on this screen and is intended to display EMG response information from the Pod If no pod is connected the screen message will show INSTALLED To alter the settings touch the window next to the required setting A dark blue margin will appear within the selected window The settings can be quickly altered using the Rotary Control Knob POWER PANEL Power Panel Power Pow
35. ctly If the b lt E P coil appears to be misaligned m X pese e remove and re connect the coil Do not use if the coil appears 8 misaligned High Power 90mm Coil additional item available P N 3193 00 The High Power 90mm Coil can be used for central motor conduction studies The design of the coil allows between 120 and 160 stimuli at the maximum power level before requiring a few minutes to cool Location The Double 70mm Coil is localised in its area of stimulation For reproducible results from cortical stimulation the most effective site of stimulation should be established and marked using the Brainsight Frameless Image Guided TMS stereotactic 3D imaging system For further information on this system please contact The Magstim Company Limited For peripheral sites the stimulation site can be marked with a suitable pen The MAGSTIM Company LTD 5 November 2009 Magstim Rapid 3576 23 09 For further information regarding coils see relevant coil operating manuals or visit the Magstim Website at www magstim com SECTION 3 SYSTEM SETUP 3 1 REAR VIEW Isolated UI Cable Trigger Port Foot Switch Mains Power Pneumatic Switch Socket Fuse Access and Voltage Cooling Fan Selector Outlet Power Entry Module HV Power Entry Socket 10A Link Lead Earth Strap HV Cable 230VPSU units shown 115V units are identical in 3 2 Power Supply Module PSU 3014 00 appearance to
36. ding Electro Magnetic emissions as is the earth strap fitted between the stimulator and the power supply unit PSU 6 Connect the HV cable from the PSU to the rear panel of the Main Frame Connect the mains link between the PSU Module and the Main Frame 7 Connect the UI Controller to the Magstim Rapid via the interface cable supplied 8 Connect the Stimulating Coil to the front panel connector of the Magstim Rapid 9 Apply mains power to the Rapid System by switching the mains power switch on the rear panel of the Rapid Main Frame to the ON position The MAGSTIM Company LTD 10 November 2009 Magstim Rapid 3576 23 09 3 7 USER INTERFACE UI Touch Sensitive Screen ARM Button TRIGGER Button ARM Button Trigger Button 5 5 5 Button 89 Output Control Knob The Magstim Rapid can be put into the ARMED mode by momentarily pushing the Green RUN button This can only be achieved if the stimulating coil is connected to the COIL OUTPUT socket The Magstim Rapid can be triggered and a magnetic pulse produced by pushing the Yellow TRIGGER button SYSTEM STOP Button The Magstim Rapid can be put into the safe inactive default mode by momentarily pushing the Red STOP button In this mode the instrument will discharge internally OUTPUT CONTROL Knob This control allows the user to change the screen selected parameter to the desired value
37. e MEP Pod is attached to the rear right hand side of the UI when viewed from the rear Remove the plastic cover to expose a 15 way D Type socket Attach the MEP Pod cable ensuring that the plug is properly inserted The plastic cover has a notch in its lower edge through which the cable must pass This cover when replaced provides strain relief for the connector Do not operate the equipment without replacing this cover as damage to the connector and the internal electronics of the UI is likely USE Attach the EMG cable to the MEP Pod and snap the free connectors onto surface type electrodes for example Kendall ARBO H124 Suitable electrodes are available from many medical supply companies and no recommendation is made as to a particular type Electrodes should be chosen which are suitable for the collection of EMG data have snap connectors and which are compliant with local regulations When connecting the electrodes follow the colour code on the MEP Pod The EMG connection cable should be screened and should be suitable for use when in direct contact with the skin No latex should be present in the cable The electrodes should be positioned on the target muscle which is controlled by the neurons being stimulated For example if the area of the motor cortex which controls the hand is to be stimulated the surface electrodes should be placed on abductor digiti minimi about 1cm apart The ground electrode should be placed on the wrist
38. e coil pins should be checked before each session 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 coil with good pins that are 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 18 the risk that the cycle of contact damage will continue As contact repair 1s 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 Battery status can be checked on the user configuration screen and when low 1s reported on the main Options Menu screen The MAGSTIM Company LTD 44 November 2009 Magstim Rapid 3576 23 09 The batte
39. e files may also be imported into spreadsheets make sure the delimited option is highlighted and the file origin is set to Arial western European The MAGSTIM Company LTD 41 November 2009 Magstim Rapid 3576 23 09 SECTION 8 SAFETY FEATURES 8 1 COIL TEMPERATURE PROTECTION An indication of the coil temperature is given by the Coil Temperature information display on the User Interface If the coil surface temperature reaches its set limit the display information will inform the user that this condition has occurred The normal operation of the equipment can then be resumed by allowing the coil to cool or alternatively by replacing the coil with a cool one 8 2 COIL DISCONNECTION If the coil is disconnected from the unit while the unit is charged the Rapid system will detect a break in communications and will automatically select the default mode and discharge internally At the same time a message will be displayed on the UI screen indicating that the coil has been disconnected The ARMED indicator will extinguish indicating that the unit 1s discharged 8 3 OTHER SAFETY MEASURES If the instrument has not been triggered for over 10 minutes after the system status window has displayed READY the unit will automatically select the default mode and discharge internally The Magstim Rapid is capable of recognising automatically the type of stimulating coil being used The MAGSTIM Company LTD 42 November 2009 Magstim
40. en The MAGSTIM Company LTD 27 November 2009 Magstim Rapid 3576 23 09 5 3 SYSTEMS DETAILS System Details This screen shows the part numbers revision and serial number information for UI MEP Pod Main Frame PSU and attached coil UI Details Software Number Version Hardware Number Revision Serial Number POD Details Software Number Hardware Number Serial Number Base Details Software Number Version Hardware Number Revision Serial Number Coil Details Software Number Version Hardware Number Revision Serial Number PSU Details H H No H H No H H No HZH No Print For Print Operations See Section 6 Back Returns the user to the System Options Menu The MAGSTIM Company LTD 28 November 2009 Magstim Rapid 3576 23 09 5 4 SYSTEM CONFIGURATION This screen is intended for Service Personnel Clear This button clears the password window Enter This button enters the current number in the password window for verification If correct the service menus are displayed Back This option returns the user to the System Options Menu screen The MAGSTIM Company LTD 29 November 2009 Magstim Rapid 3576 23 09 SECTION 6 DATA RETRIEVAL 6 1 FILE MAINTENANCE WINDOW The file maintenance window allows the user to enter a file name and store protocols These may be generic protocols which are chosen for a patient The protocols may be stored internally or may be stored on a memory card See sec
41. ent is not available replacement shipping cartons can be obtained from the Magstim Company Service Department IMPORTANT The Rapid System must be completely disconnected before shipping including removal of the coil holder on the side of the Rapid Failure to do so 1s likely to result in transit damage to the casing 9 6 DEVICE LIFETIME 9 7 DISPOSAL The lifetime of the Magstim Rapid System is defined as being 5 years from the date of shipment The Magstim Company Ltd will support the product for the duration of its lifetime When the Magstim Rapid System 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 LTD 46 November 2009 Magstim Rapid 3576 23 09 SECTION 10 SPECIFICATIONS 10 1 GENERAL SPECIFICATIONS Protection against ingress of liquids Protection against flammable anaesthetic mixtures Mode of Operation EMC General EMC Susceptibility EMC Emissions 10 2 POWER This equipment is classified as Class 1 with type BF Applied Parts It is designed to comply with the requirements of the Safety Standard EN60601 1 90 including amendment 1 91 and amendment 2 95 and EMC Standard EN 60601 1 2 with the exception of immunity clause 36 202 5 Surges The Magstim Rapid System and its accessories are classified as IPX
42. er e Parameters xMT f 100x Protocol Intensity Enhanced m Trace Window Stimulator Output 30x TE Window Ti Cursors a NOT INSTALLED Cu iz f ine Amplitude Coil Status sors Display Repetitive Save gt Session System Status The Power Panel is selected by pressing the Power button When Power is selected the button turns green Power To adjust the system power level touch the Stimulator Output window on the Power Panel The power level is set to the default value of 30 The power can be increased or decreased in 1 increments by using the Rotary Control Knob Each complete 360 rotation changes the output level by approximately 20 MT The MT Motor Threshold window displays the percentage of stimulator output which is to be transferred to the Protocol Intensity window The MT cannot be adjusted to give more than the 100 in the Protocol Intensity window Enhanced This option enables the power level to be increased up to 110 power This option is only available in Single Pulse Mode If Repetitive Mode or Session Mode is accessed via Single Pulse Mode the Protocol intensity value will be carried over into these modes All other configurable Single Pulse Mode options are available only when the MEP Pod is connected NOTE The Rapid must be switched off before connecting or disconnecting the MEP Pod The MAGS
43. er into the power window Add Copy Line Delete Line Delete Page Up Scroll Up Scroll Down Page Down Print Run Session Save Session Options Menu Selection of this option press the window to select enables the user to copy the session line settings of the selected line and copy them into the next line Selection of this option will delete the highlighted line This button will delete all lines allowing the user to start writing a new protocol Pressing this button will allow the user to move up pages if the protocol has more lines than will fit on a single screen This allows the user to move up one line at a time Selection of this option allows the user to scroll down one line at the time to view train lines below those displayed on the screen There are up to 30 lines available Moves down a page at a time if the Protocol has more lines than will fit on a single screen For Print operations see Section 6 Selection of this option will call up the Session Mode screen Selection of this option will call up the File Maintenance screen See section 6 and allows the user to save the session set up Selection of this option will return the user to the Options Menu screen The MAGSTIM Company LTD 24 November 2009 Magstim Rapid 3576 23 09 4 10 SESSION MODE Channel 1 Session Details f Total f Power 15x Pulses 230 0 Line 1 45 20 0 og 5 05 gt 50 Chan
44. haracter Enter details using the on screen keyboard Press the window to select The Patient ID window can accept up to 18 characters Enter details using the on screen keyboard Press the window to select The Patient Date of Birth window can accept up to 18 characters Enter details using the on screen keyboard Press the window to select Enter details using the on screen keyboard Press the window to select The Comments window can accept up to 273 characters Enter details using the on screen keyboard Once the details have been entered into a window further selection of the window will produce a Save changes in the last window box The changes made can be saved by selecting Yes To disregard the information entered press No For Print Operations See Section 6 4 Selection of this option will clear the contents of all the patient details windows after a Yes confirmation has been entered If a patient file is open the patient details will be removed from the file Selection of this option will call up the File Maintenance screen Selection of this option will return the user to the Options Menu Screen The MAGSTIM Company LTD 31 November 2009 Magstim Rapid 3576 23 09 6 3 CREATING AND USING FILES SSS SS emus ums UNUS eas gt gt SAE gt gt gt gt gt gt gt gt gt gt gt
45. he system going into a coil over temp condition and reverting to its discharged state It is important that if this type of operation is intended the protocol be run prior to use on a patient and the surface temperature of the coil monitored to ensure that the patient is not exposed to excessive temperatures NOTE If the external trigger is set to the level triggering option it is possible for auto triggering to Occur IMPORTANT The temperature of the system 18 internal components becomes elevated during operation The system should be left on and uncovered for approximately ten minutes following completion of stimulation to enable the fan to cool the internal system components The MAGSTIM Company LTD 12 November 2009 Magstim Rapid 3576 23 09 SECTION 4 SYSTEM OPERATION INSTRUCTIONS Switch on the system using the ON OFF STANDBY button on the front of the Rapid Main Frame 4 1 WELCOME SCREEN The UI will activate automatically The Welcome Screen will be displayed The system will fully initialise and the Options Menu will appear after 15 seconds Pressing the Continue button before the system has fully initialised gives access to the following options Single Pulse Mode System File Maintenance The system needs to be fully initialised before Repetitive Mode and Session Mode are accessible The MAGSTIM Company LTD 13 November 2009 Magstim Rapid 3576 23 09 4 2 MAIN OPTIONS MENU sele
46. hen a stimulation occurs The maximum update rate for the trace window is 4 times a second depending on the amount of information to be displayed If the amplitude cursors are active then the last position set for each cursor in Single Pulse Mode will be displayed The cursor position will remain fixed until Single Pulse Mode is re entered In order to save the trace it is necessary to go back to Single Pulse Mode and save the data as before The information will remain on each trace window until a new trace is generated when the new trace will overwrite the previous trace This Option is available if the system is armed and the previous session was not completed Selecting Resume will return the session to the point at which it was stopped at the beginning at the start of the next cycle regardless of when the last cycle was stopped Selection of this option will return the user to the Repetitive Setup screen Selecting this option will return the user to the Single Pulse Mode screen Selection of this option will return the user to the Options Menu screen 23 November 2009 Magstim Rapid 3576 23 09 4 9 SESSION MODE SETUP This screen allows the user to set up a series of individual lines each with different Power Frequency Duration and Number of Pulses parameters See section 4 5 for limits If Session Setup is accessed from Single Pulse Mode the protocol intensity value established in Single Pulse Mode will be carried ov
47. his should open the Roll Paper Cover 2 Align the edges of the paper roll against the paper holders and push down gently 3 Pull the paper through and close the cover The Printer is now ready to be used On Off over Button Button Cover Open A Button The MAGSTIM Company LTD 9 November 2009 Magstim Rapid 3576 23 09 3 6 SET UP 1 Before using the instrument ensure that the correct fuses are fitted and that the voltage selector is set to suit the country s supply voltage this statement applies to the Rapid Main Frame only There are 2 fuses rated at 1 25A for both 115 10 and 230V 10 For information on changing the fuses please see Section 9 2 Place the system in a room near multiple power sockets and ensure easy access to and around the equipment 3 Label the entrances to the room to warn of the presence of strong magnetic fields and to exclude those wearing pacemakers and or electronic implants 4 Connect the power cables provided to the power supply socket s on the rear of the PSU The power requirement of the Magstim Rapid depends on the PSU used and the parameters set by the UI 5 The power cables must be connected directly to wall power outlet sockets and not via a terminal block The Rapid System must be used only with the supplied mains leads fitted with an integral filter as they are required to maintain the System s compliance with EN 60601 1 2 regar
48. ications equipment transmitters and the Magstim Rapid System as recommended below according to the maximum output power of the communications Rated maximum output Separation distance according to frequency of transmitter power of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 35 o 3 5 7 d vV P d 4VP d 4VP Vi Where V 3 Where 3 Where 3 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738 1 1 167 1 167 2 333 10 3 689 3 689 7 379 100 11 667 11 667 23 333 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The MAGSTIM Company LTD 55 November 2009 Magstim Rapid 3576 23 09 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Magstim Rapid System is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such a
49. ied to the external connections with respect to ground Connection Not Less Than Not Greater Than Logic Low Logic High Trigger Input 0 3 0 8 V 4 5 3V Trigger Output 0 3 0 8V 4 5 3 10 8 GENERAL Rapid Main Frame Size Width 460mm Height 160mm Depth 375mm Weight 13 1kg PSU 3013 00 Size Width 460mm Height 160mm Depth 375mm Weight 13 2kg PSU 3014 00 Size Width 460mm Height 160mm Depth 375mm Weight 23 4kg UI Size Width 360mm Height 240mm Depth 280mm Weight 2 6kg IMPORTANT The system must be disassembled prior to being moved The parts of the system are not locked together in any way and are likely to fall if moved together resulting in damage to the equipment and possible injury to those near to or those transporting it The MAGSTIM Company LTD 53 November 2009 Magstim Rapid 3576 23 09 10 9 HANDLING CAUTION The Magstim Rapid System Main Frame and PSU weigh in excess of 20kg Therefore if it is necessary to move the units for any reason the weight must be distributed between at least two persons see diagram below for recommended manual handling methods NOTE The weight of PSU 3013 00 is unevenly distributed the left hand side of the unit being considerably heavier than the right hand side Care should be taken when transporting the unit to ensure that this heavier side is adequately supported Shoulder height Shoulder height Elbow height Elbow height Knuckle height Knuckle height Mid
50. in Repetitive Setup Channels 1 2 and Both Selecting Channel 1 Channel 2 or Both determines whether both traces are shown simultaneously or individually COIL STATUS PANEL The Coil Status panel will show the temperature and type of coil SYSTEM STATUS PANEL The System Status panel shows the system status Trace Window The Trace window will be updated when a stimulation occurs The maximum update rate for the trace window is 4 times a second depending on the amount of information to be displayed If the amplitude cursors are active then the last position set for each cursor in Single Pulse Mode will be displayed The cursor position will remain fixed until Single Pulse Mode is re entered In order to save the traces it is necessary to return to Single Pulse Mode and save the data as before The information will remain on each trace window until a new trace is generated when the new trace will overwrite the previous trace Resume This option is available if the system is armed and the previous session was not completed Selecting Resume will return the session to the point at which it was stopped beginning at the start of the next train regardless of when the last train was stopped Setup Selection of this option will return the user to the Repetitive Setup screen Single Pulse Selecting this option will return the user to the Single Pulse Mode screen Options Menu Selection of this option will return the user to the Options Menu scree
51. invalid number will result in the file not being imported correctly File Time This line defines when the file was created on the UI The range for each value is a follows seconds 0 59 minutes 0 59 hours 1 23 day 1 31 month 1 12 year 1970 2100 Name This is the name that appears in the patient data name window on the UI and must not exceed 40 characters The name can contain any character except a comma Sex This is the character that appears in the patient data sex window and must not exceed 1 character The character can be any character except a comma ID This is the string that appears in the patient ID window on the UI and must not exceed 18 characters The string can contain any character except a comma Date of birth This is the string that appears in the patient date of birth window on the UI and must not exceed 18 characters The date string can contain any character except a comma Protocol description This is the string that appears in the patient protocol description window on the Ul and must not exceed 46 characters The string can contain any character except a comma Comments This is the string that appears in the patient comments window on the UI and must not exceed 273 characters The string can contain any character except a comma Train This line contains the parameters displayed on the repetitive set up screen on the UI Standard mode The individual parameter value ranges are as follows Power 0 100
52. ited will only accept responsibility for the effects on safety reliability and performance of the equipment if e modifications or repairs are carried out by persons authorised by The Magstim Company Limited e the electrical installation of the relevant room complies with local regulations and e the equipment is used in accordance with the instructions for use The MAGSTIM Company LTD November 2009 Magstim Rapid 3576 23 09 SECTION 1 WARNINGS AND PRECAUTIONS CAUTION Magnetic stimulation has not been cleared by the FDA for cortical stimulation Investigational human uses require that the user complies with the FDA regulations regarding Investigational Devices USA Only 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 Magstim Rapid CAUTION The Magstim Rapid and its 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 Magstim Rapid its coils and accessories generate high intensity magnetic pulses The induced eddy current is of sufficient magnitude to stimulate nerves and muscle The stro
53. ksum U37 Battery Voltage Low U38 Bad External Flash Checksum Detected 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 Invalid temperature algorithm coefficient C10 Coil controller malfunction The MAGSTIM Company LTD 36 November 2009 Magstim Rapid 3576 23 09 C21 Coil Disconnected Coil Under Temperature C22 Brown Out Detected C23 No serial Communications C24 Bad Serial command of received data checksum outside TRIGGATE C25 EMC Detected Coil adapter only C26 Invalid Coil Power Identification Coil adapter only C27 Hardware Stop activated C28 Watchdog Timeout C29 Temperature Interlock 3 activation C30 Coil stop line fault Error codes produced by base system Error Codes Description E61 Power fail E62 Stack underflow E63 Stack overflow E64 RTS overrun E65 WD Timeout E66 Unexpected reset E67 Bad checksum E68 SYS debug error E70 Coil under temperature E71 Coil max difference E72 Stack over temperature E73 Stack under temperature E75 HVCAP over temperature E77 Charge threshold failure E78 VREF check failure The MAGSTIM Compa
54. lation and trigger pulses initiate brief magnetic pulses The magnetic fields can pass through clothing tissue and bone to reach otherwise inaccessible areas One feature of magnetic stimulation is that it is less likely to stimulate pain fibres at the skin surface reducing the discomfort when compared with conventional electrical stimulation Magstim Rapid magnetic stimulators combine stimulation frequencies from 1Hz to 100Hz with a touch screen interface which controls every aspect of the stimulator s control and operation INDICATIONS FOR USE The Magstim Rapid magnetic nerve stimulator systems are intended for the stimulation of peripheral nerves and the human cortex for diagnostic and research purposes CONTRAINDICATIONS Magstim Rapid systems and their accessories should not be used on or in the vicinity of patients or users with cardiac demand pacemakers implanted defibrillators and or implanted neurostimulators CAUTION Check the Magstim Rapid System and its accessories for any signs of damage If the Magstim Rapid System or any of its accessories damaged in any way they must not be used Federal law restricts this device to sale by or on the order ofa practitioner licensed by the law of the State in which he she practices to use or order the use of the device To avoid interference problems Magstim Rapid and its accessories should not be used in the vicinity of any equipment that does not comply with E
55. layed on the UI for channel 2 when the save traces button on the single pulse screen on the UI was selected and the exported file was open for modification Each of the 300 data values is within the range 0 255 To determine the actual voltage recorded for each MEP data value the value has to be scaled according to the voltage range that was selected at the time the reading was made The voltage range setting for each channel is recorded on the MEP Configuration data line of the file MEP Configuration This line contains the details of how the MEP was configured when the MEP waveforms were saved using save traces button on the single pulse screen on the UI The meaning for each value are as follows Time base index possible values and meanings are as follow 0 20 ms 1 50 ms 2 100 ms 3 200 ms 4 500 ms Channel voltage range index possible values and meanings are as follows 0 150uV 1 3004V 2 600LV 3 1 5mV 4 3 5 6mV 6 15mV 7 30mV Channel 2 voltage range index possible values and meanings are as follows 0 150uV 1 3004V 2 600 3 1 5mV 4 3mV 5 6mV 6 15mV 7 30mV Special feature always 0 Filters index possible values and meanings are as follows 0 2 2 10KHz 1 20Hz 10KHz Note The information stored on the SD Card is of the text format comma delimited The file can be imported into any text editor to view or to modify the contents Th
56. n The MAGSTIM Company LTD 21 November 2009 Magstim Rapid 3576 23 09 4 7 REPETITIVE MODE BURST SETUP Select Burst Mode from the Repetitive Setup screen to allow the following adjustable parameters to be set If Repetitive Setup 1s accessed from Single Pulse Mode the protocol intensity value established in Single Pulse Mode will be carried over into the power window Power Frequency Number of Pulses Number of Bursts Burst Frequency Cycle Time Number of Cycles Print Run Session Save Session Options Menu The MAGSTIM Company LTD 22 Selecting the Power window allows you to adjust the power level between 096 and 10095 using the Rotary Control Knob Selecting the Frequency window will allow the user to set the frequency of the pulses to a value between 0 and Fy Hz 1Hz increments The maximum frequency can be up to 100Hz depending on the power level set and the system configuration A table detailing the available power frequency combinations is included in Section 10 Selecting the Number of Pulses window allows the user to set the number of pulses per Burst The Number of Pulses can be set between 1 and 10 using the Rotary Control Knob Selecting the Number of Bursts window allows the user to set the number of bursts in a cycle The number can be set between and 500 in increments of 1 Selecting the Burst Frequency window allows the user to set the Burst frequency be
57. n environment Immunity Test IEC 60601 Compliance Electromagnetic environment Test Level Level guidance Electrostatic 6 kV contact Meets requirement Floors should be wood concrete or ceramic discharge ESD 8 kV air tile If floors are covered with synthetic material the relative humidity should be at IEC 61000 4 4 least 30 Electrical fast 2 kV for power Meets requirement Mains power quality should be that of a Transient burst supply lines Resetting of the typical commercial or hospital MEP Pod may be environment IEC 61000 4 11 1 kV for input output lines experienced during single shot mode under these conditions Surge IEC 61000 4 5 1 kV differential mode 2 common Differential mode compliant Common mode Anti surge protection needs to be incorporated into the main supply to the equipment if surge protection is to be guaranteed mode compliant to 1kV only Voltage dips 5 Ur Meets requirement Mains power quality should be that of a short interruptions and voltage variations on power supply input lines IEC 61000 4 11 295 dip in Ur for 0 5 cycle 40 Ut 60 dip in for 5 cycles 70 Ur 30 dip in for 25 cycles 5 Ur 795 dip in for 5 sec typical commercial or hospital environment If the user of the Magstim Rapid System requires continued operation during power interruptions it is recommended
58. nector has a hole deliberately blocked to prevent incorrect connection 100Hz must not be used for cortical stimulation it is for peripheral The MAGSTIM Company LTD 4 November 2009 Magstim Rapid 3576 23 09 use only For safety guidelines relating to transcranial stimulation see Section 9 of this Operating Manual The Stimulating Coil must not be discharged in the vicinity of the patient s heart 2 3 COILS A variety of coils is recommended to stimulate specific neutral pathways These coils have their coil heads labelled with blue arrows which 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 Double 70mm Coil 2 Generation Double 70mm Stimulating Coil P N 3191 00 Also Standard Double 70mm Stimulating Coil P N 9925 00 The Double 70mm coil is capable of accurate stimulation of cortical areas and spinal nerve roots Applications Include Selective monohemispheric transcranial stimulation Excitation of spinal roots Motor cortex Peripheral nerves Coil Adapter Coil P N 9925 00 must be connected to the stimulator via the supplied coil adaptor P N 3110 00 This coil will not function if connected directly to the stimulator hiv 181 3 s TN Please note it is important that the i cdd EN coil is connected corre
59. nel 2 anne 3 0s 8 10Hz 5 0 8 18Hz 18 05 Coil Status Channel 1 Temperature 0 m D70 R Channel 2 System Status f Coil ok to run session Resume Single Pulse Options Menu SESSION DETAILS Session Details shows a pictorial representation of 3 lines of the session running currently Channels 1 2 and Both Selecting Channel 1 Channel 2 and Both determines whether both traces are shown simultaneously or individually Trace Window The Trace Window will be updated when a stimulation occurs The maximum update rate for the trace window is 4 times a second depending on the amount of information to be displayed If the amplitude cursors are active then the last position set for each cursor in Single Pulse Mode will be displayed The cursor position will remain fixed until Single Pulse Mode is re entered In order to save the trace it is necessary to go back to Single Pulse Mode and save the data as before The information will remain on each trace window until a new trace is generated when the new trace will overwrite the previous trace Resume This Option is available if the system is armed and the previous session was not completed This option will return the session to the point at which it was stopped This will always begin at the start of the next session line regardless of when the last session line was stopped In order to save the traces it is necessary to go back to Single Pul
60. ng is 200uV The MAGSTIM Company LTD 16 November 2009 Magstim Rapid TIME CURSORS PANEL Channel 1 Channel 2 Session Power o Parameters oe Time 3576 23 09 Time Cursors status f OFF Channel 1 Latencies uf uf Channel 2 Latencies uf lef 1 Coil Status f System Status Options Menu Press the Time Cursors button green when selected to access the Time Cursors panel Status Select the Status window to turn the Latency Cursors on and off The default setting is OFF Select L1 or L2 to activate a cursor for adjustment When the cursors are active Channel 1 Latencies their current screen time value will be displayed on the trace window The trace of the selected cursor can be moved using the Rotary Control Knob for example to identify the time of an event Select L1 or L2 to activate a cursor for adjustment When the cursors are active Channel 2 their current screen time value will be displayed on the trace window The trace of Latencies the selected cursor can be moved using the Rotary Control Knob for example to identify the time of an event The MAGSTIM Company LTD 17 November 2009 Magstim Rapid 3576 23 09 AMPLITUDE CURSORS PANEL Channel 1 Amplitude Cursors Status JE Parameters j Corr Trace 1 f Time Trace 2 Channel 2 Coil Status System Status
61. ng magnetic pulses generated by 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 coil can couple resulting in currents being induced in them Caution for safety reasons do not leave patient cables attached to the MEP Pod if they are not being used If an unused cable is left connected and the patient is connected to the other channel there is the possibility that the unused cable may touch an earthed surface which could allow current to flow through the patient to ground Caution do not allow the coil or the coil cable to come into close proximity with the MEP Pod patient cables During discharge current may be induced in these cables Do not discharge the Magstim with the stimulating coil in the vicinity of metallic objects or these may be projected moved and or damaged The Magstim Rapid 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 Magstim Rapid and its 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 High voltages are present within this System Do not remove covers Refer
62. ntain the parameters displayed on the session set up screen on the UI The individual parameter value ranges for line 1 are the same for all 30 lines and are as follows The MAGSTIM Company LTD 40 November 2009 Magstim Rapid 3576 23 09 Start time for line 1 has to be zero The start time on the other lines should be determined using the following equation start time previous line start time duration wait time Power 0 100 at a resolution of 1 Frequency 1 100 Hz at a resolution of 1Hz Note the settable power to frequency values is determined by the system configuration see user manual for Rapid system for more details Duration 0 1 10 0 seconds at a resolution of 0 1 seconds Number of pulses 1 1000 at a resolution of 1 Wait time 1 0 60 0 seconds at a resolution of 0 1 seconds Note all time periods are specified in multiples of tenths of a second i e if a time period of 6 5 seconds is required then a value of 65 is entered between the commas MEP 0 This line contains the MEP data column headings MEPS x These lines contain a single reading for each trace stored in the file Trace 1 column contains the waveform that was displayed on the UI for channel 1 when the save traces button on the single pulse screen on the UI was selected and the exported file was open for modification Each of the 300 data values is within the range 0 255 Trace 2 column contains the waveform that was disp
63. ny LTD 37 November 2009 Magstim Rapid 3576 23 09 E79 HVCAP voltage comparison failure E80 Charging fault E81 HV over voltage E82 Invalid system configuration E83 Stop line fault E84 Base coil stop line fault E85 UI stop line fault E86 Dump system fault WARNING high voltage may be present up to 20 minutes after use on internal high voltage capacitor E87 Invalid coil category for current system configuration E88 Invalid NVRAM Checksum Base arm LED drive failure E90 External PSU Fault E91 Base over temperature E92 Snubber Board over temperature E93 Base under temperature E94 HC CAP under temperature E95 Snubber Board under temperature E96 Ambient over temperature E97 System failed to produce protocol E98 The MAGSTIM Company LTD 38 November 2009 Magstim Rapid 3576 23 09 7 2 ISOLATED TRIGGER I O PORT 1 WARNING Only equipment complying with EN 60601 1 and configured in compliance with EN 60601 1 should be connected to the trigger output and or trigger input Connection must be via Trigger Input Output Cable P N 600003 in order to maintain System EMC Compliance 5V CMOS Logic Levels Pin Connections 1 Aux GND 14 N C 2 N C 15 N C 3 Tout O C 16 N C 4 N C 17 N C 5 Hive Trigger In 18 N C 6 ive Trigger In 19 Aux GND 7 Trigger Out 20 End Train 8 ive Trigger Out 21 N C 9 N C 22 N C 10
64. on the trigger button or on the UI A clicking noise will emanate from both the stimulating coil and the Magstim Rapid each time the Magstim Rapid is triggered This indicates that a magnetic pulse is being delivered by the stimulating coil which is stimulating the nerves beneath it When necessary it is possible to reposition the stimulating coil and or to modify the power level on the UI to suit the requirements for the next stimulus Meanwhile the system will have recharged and can be triggered once again in the normal manner When the stimulations have been completed press the SYSTEM STOP button on the UI The system can only be fired when one of the following UI screens is displayed Single Pulse Mode Repetitive Mode Session Mode EXTERNAL TRIGGERING If an external triggering device is used the Rapid uses the power set to govern the maximum discharge frequency Therefore if the external frequency is set higher than the power set will allow the stimulator will discharge at the maximum rate the stimulator can achieve for the power set and not at the rate from the external trigger source In these situations reducing the power will allow the discharge frequency to increase However during external triggering there are no duration limits on the trains Therefore it is probable under high frequency operation that enough energy will be discharged into the coil to result in its temperature rising rapidly above 40 C following t
65. ormation that is stored within the Magstim Rapid The Print option allows for screen or file information to be obtained on paper In any screen where the Print Button is visible the Printer can produce a reproduction of the information that is displayed on screen This option is available in Single Pulse Mode Power Screen Repetitive Setup Session Setup System Details File Maintenance and Patient Details Once the Print Button is pressed the selected item automatically begins to print unless the previous print process was cancelled in which case follow the instructions on screen The print process may be cancelled at any time by pressing the Cancel button EXAMPLE SINGLE PULSE MODE Once the chosen information is generated up on screen the Print button can be pressed to produce printout see below Screen Printout magstim gt ro gt Purser oe Ss ER EXAMPLE PATIENT DETAILS Screen Printout magstim The MAGSTIM Company LTD 35 November 2009 Magstim Rapid 3576 23 09 SECTION 7 SYSTEM STATUS CODES BASE Controller Error Codes produced by the User Interface Error Codes Description U24 UI Power Supply Failure U25 Stack underflow U26 Stack overflow U27 RTS overrun U28 Watchdog Timeout U29 ROM Checksum Incorrect U34 No serial communications U35 Loss of communication U36 Bad NVRAM Chec
66. quired for the selected protocol is greater than that selected the UI will display a message Wait period too short auto set to minimum Select YES to set the wait delay to the minimum allowed for the chosen protocol Select NO to reset the protocol parameters manually Selection of this option allows the user to set the number of times that the specified train runs to a value between 1 and 250 in steps of 1 Appears at the base of the screen The Information Window provides information such as Coil OK to run and alerts the user to actions required protocols that are unable to be completed or equipment which needs to be attached For Print operations see Section 6 Save Session takes the user to the File Maintenance screen See section 6 Selection of this option will return the user to the Options Menu screen This screen takes the user to the Repetitive Mode screen in order to run a session November 2009 Magstim Rapid 3576 23 09 4 6 REPETITIVE MODE STANDARD Channel 1 Session Details Power f 30 7 Total Pulses Total f 17 Train Trains Number 28 Channel 2 2 85 16H 2 iz Coil Status Channel 1 Temperature erem e ture f Channel 2 System Status Both Resume Setup Single Pulse Options Menu SESSION DETAILS The Session Details panel shows a pictorial representation of the train currently running and shows the settings established
67. ries in the UI will require to be replaced every 2 years To do so unplug the UI connector turn the UI upside down remove the 4 cross head screws visible and detach the plastic bottom of the UI Have the new batteries available The UI has a small capacitor which will maintain the internal settings for about 20 seconds once the old batteries are removed It is important that the batteries are replaced within the 20 seconds if data is not to be lost Before removing the old batteries ensure you have the correct replacements and that you are clear about the orientation of the batteries Once inserted replace the bottom of the UI and fix using the screws Do not over tighten Do not use re chargeable batteries When spent the batteries should be disposed of under the appropriate environmental regulations It 1s advisable that the batteries be removed from the UI if the equipment is likely to be un used for a long period of time 9 4 CLEANING AND DISINFECTING 9 5 SERVICING The stimulating coil exterior of main frame PSU UI foot switch MEP Pod and MEP Pod patient cables may be cleaned using an isopropyl alcohol moistened cloth Ensure that the equipment has dried thoroughly before use Note 1 The coil cannot be sterilised Do not allow the coil to become contaminated with body fluids Note 2 Do not clean or wipe the touch screen with anything abrasive as it will cause permanent damage All servicing must be carried out by the
68. se Mode and save the data as before The information will remain on each trace window until a new trace is generated Then it will be overwritten by a new one Setup Selection of this option will return the user to the Repetitive Setup screen Single Pulse Selecting this option will return the user to the Single Pulse Mode screen Options Menu Selection of this option will return the user to the Options Menu screen The MAGSTIM Company LTD 25 November 2009 Magstim Rapid 3576 23 09 SECTION 5 SYSTEM 5 1 SYSTEM OPTIONS MENU User Configuration Selection of this option will call up the User Configuration Screen System Details Selection of this option will call up the System Details Screen System Configuration Selection of this option will call up the System Configuration Screen Options Menu Selection of this option will return the user to the Options Menu Screen The MAGSTIM Company LTD 26 November 2009 Magstim Rapid 3576 23 09 5 2 USER CONFIGURATION User Configuration This screen allows the user to set system parameters which are stored in Volume Contrast Coil Switch Option Date Time Modify Language Setup Battery Voltage Back Options Menu an area of the UI s memory which is battery powered 1 10 2005 10 00 00 This allows the user to set the screen selection beep volume by selecting the window and using the Rotary Control Knob This allows the user to adjust the TFT contrast option from 1
69. t 80 power level 4 x 10 discharges at 90 power level 2 x 10 discharges at 100 power level 10 5 OUTPUT SAFETY REPETITION RATE OF STIMULUS The following Table is taken from Eric M Wassermann s paper Risk and Safety of Repetitive Transcranial Magnetic Stimulation Report and recommendations from the International workshop on the safety of Repetitive Transcranial Magnetic Stimulation June 5 7 1996 It gives the maximum safe duration in seconds of single trains of rTMS based the NINDS experience Intensity of MEP threshold Frequency 100 110 120 130 140 150 160 170 180 190 200 210 220 2 1 gt 1800 gt 180 360 gt 50 gt 50 gt 50 gt 50 27 11 11 8 7 6 0 5 gt 10 gt 10 gt 10 gt 0 76 5 2 3 6 2 6 2 4 1 6 1 4 1 6 1 2 10 gt 5 gt 5 4 2 2 9 1 3 0 8 0 9 0 8 0 5 0 6 0 4 0 3 0 3 20 2 05 1 6 1 0 0 55 0 35 025 025 015 02 025 02 0 1 0 1 25 1 28 0 84 0 4 024 02 024 02 012 008 0 12 012 0 08 0 08 Numbers preceded by the symbol gt are the longest durations tested No after discharge or spread of excitation has been encountered with single trains of rTMS at these combinations of stimulus frequency and intensity Magnetic Field The magnetic field produced by the Magstim Rapid depends on the type of coil connected In the case of the Double 70mm Coil supplied with the system the field output is 1 2T at the surface of the coil Pulse Characteristics Biphasic Single Cosine Cycle 400 5 period The MAGSTIM Company LTD
70. this operating manual No pins of connectors identified with the ESD warning symbol should be touched The connectors involved are those to be found on the rear of the User Interface Connections should not be made to these connectors unless ESD precautionary procedures are used All staff responsible for using the Magstim Rapid System should receive an explanation of the ESD warning symbol and receive training in ESD precautionary procedures Connection should be made only by a person who is wearing a conductive wrist strap which is connected to a suitable tested earth connection or following the person grounding themselves by touching a part of the external casing connected to protective earth The MAGSTIM Company LTD 2 November 2009 Magstim Rapid 3576 23 09 SECTION 2 PRODUCT DESCRIPTION 2 1 RAPID Unit Power Status Indicator e Flashes when the system is in STANDBY Oncontinuously when the system is ON ON OFF STANDBY This switch toggles the operational state of the Rapid ARMED Indicator This LED 18 continuously illuminated when the system is armed and high voltages 7 2 are present in the system A Main A magstim R Frame Coil OUTPUT Socket m See below for description PSU Power Status Indicator E O fy e OFF when system is in j d STANDBY OFF e Oncontinuously when system is ON PSU ARMED FAUL T Indicator This LED is continuously illuminated
71. tion 6 3 Keyboard View New Open Rename Delete Export Import Print Patient Details gt File Store empty mm No card fitted SS Se SS SS SEE SSS SS SS Ed eS SS SS gt le oe ALL The keyboard is touch sensitive A file name needs to be selected in order to edit it Select the Local Store screen and use the Rotary control knob to scroll between files Selection of View reloads the data stored in the selected file located in the local store window The file name will be displayed in the top right hand corner of the screen Selection of New allows the user to create a new file in the local store window The file name entered must be between 1 and 18 characters long and different from any other file name Selection of Open will reload the data stored in the selected file Once the file is opened the Open button will change to Close to enable the file to be closed The file name will be displayed in the top right hand corner of the screen Selection of this option will allow the user to enter a new name for a chosen File Name Use the keyboard to make changes to the file name and press save on the keyboard to confirm Selection of this option will allow the user to delete the selected file from the local store window after a Yes confirmation
72. tween 1Hz and 10Hz Selecting the Cycle Time window allows the user to set the time for each cycle in seconds The time can be set between and 60 seconds in increments of 0 1 seconds Selecting the Number of Cycles window allows the user to set the number of cycles in a session The value may be set between and 250 in increments of 1 For Print operations See Section 6 This screen takes the user to the Repetitive Mode Screen to run a session Save Session takes the user to the File Maintenance screen See section 6 Selection of this option will return the user to the Options Menu screen November 2009 Magstim Rapid 3576 23 09 4 8 REPETITIVE MODE BURST Channel 1 Channel 2 Session Details Total BEC Pulses f 30x f 17 f 30 deies f l 10 8 SHz Cycle Number 3 05 v Coil Status Channel 1 Temperature cem Channel 2 System Status mmm Both Type Resume Single Pulse gt Options Menu SESSION DETAILS PANEL Channels 1 2 and Both Trace Window Resume Setup Single Pulse Options Menu The MAGSTIM Company LTD The Session Details panel shows a pictorial representation of the cycle currently running and shows the settings established in Repetitive Setup Selecting Channel 1 Channel 2 and Both determines whether both traces are shown simultaneously or individually The Trace Window will be updated w
73. xpectancy 0 5 Output 0 6 Coil Compatibility 0 7 UI Rear Panel 0 8 General 0 9 Handling Section 11 EMC Emissions and Immunity Section 12 Rapid System Packages The MAGSTIM Company LTD 3576 23 09 13 26 31 37 42 44 48 56 59 November 2009 Magstim Rapid 3576 23 09 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 capacitor is guaranteed for one year or 1 000 000 discharges which ever comes first The Magstim Company Limited reserves the right to perform guarantee 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 1f said defects occur during normal service Claims for damages during shipment must be filed promptly with the transportation company correspondence concerning the equipment must specify both 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 Limited from any further guarantee obligations The Magstim Company Lim
74. y storage facility enables transfer This socket is situated the rear of the left hand side panel of UI This allows of data between the UI and external devices such as PCs 15 Way D Type Connector situated on rear of UI behind cover This connector is situated on the rear of the UI behind the removable cover It is N designed to accept the Motor Evoked Potential MEP pod available as a separate item It has type BF connection The MAGSTIM Company LTD 7 November 2009 Magstim Rapid 3576 23 09 3 4 MEP POD CONNECTION NOTE The Rapid must be switched off before connecting or disconnecting the Pod The Motor Evoked Potential MEP Pod is an optional component which allows the user to capture EMG signals and display them on the UI 2 channels are available The MEP Pod should be mounted as close as possible to the subject but should be kept away from sources of interference such as power cables It is recommended that all EMG cables are screened to minimise interference The MEP Pod is designed to be used with surface electrodes only The MEP Pod is designed to be fitted to the Magstim Rapid UI only Do not attempt to connect it to a computer or any other equipment with a similar connector To do so could result in electric shock burns to the patient at the site of electrode attachment The MEP Pod connector has a hole deliberately blocked to prevent incorrect connection CONNECTION Th

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