- Frank`s Hospital Workshop
Contents
1. Figure 10 TWISTER main controls Help Help window with short instructions Single Burst Shape Pulse type selection for single pulses burst pulses or pulse shapes The active button is marked in yellow colour If burst pulse or pulse shape is selected the configured pulse shape is displayed in the pulse preview window in the upper right corner of the main window Figure 11 Figure 11 Pulse preview If single pulse is selected the pulse preview appears dimmed Pulse Shape Editor A window will open after pushing this button showing the pulse shape editor for programming free pulse shapes If pulse shape is selected as the type the buttons lt Edit Pulse shape gt and lt Select Pulse shape gt appear enabled and active TWISTER Softwareversion 1 19 Page 22 of 46 Version 1 19 4 2010 05 31 Select Pulse shape To select a pulse shape from a directory of stored pulse shapes Figure 12 If pulse shape is selected as pulse type the lt Select Pulse shape gt button appears enabled and active Status Display Performance With the key combination lt Ctrl gt lt Shift gt lt F1 gt status indicators are displayed to check the performance of the PC system controlling the TWISTER hardware Contact the service to get more information about the status controls A Twister 1 15 DS Auswahl der Pulsdatei Suchen in ES Files D e EI ex ES Pulse cortical pul Verlauf i Desktop A Eigene Dateie2. 2 X 200 mA T Safety class with protective earth conductor WS WS WS WS WS WS WS WS WS WS WS WS WS NS US US WS WS ST Protection class IP40 TWISTER Softwareversion 1 19 Page 43 of 46 Version 1 19 4 2010 05 31 11 Serial number design TW XXX 12 2007 Twister Consecutive No Calendar week Year of manufacture 12 Disposal of waste The TWISTER stimulator has to be disposed according to the locally valid instructions and standards for electronic scrap 13 Cleaning The TWISTER device has to be cleaned with a moist cloth or disinfection by wipe Cleaning agents must not be used 14 Service and repair The intended use is based on the compliance with the required service intervals Service intervals Prior to each operation Visual examination for damages of the housing and accessories and functional test is required Annually Measurement of the leakage currents and the resistance of the protective earth wire according to IEC601 1 safety check has to be done by the manufacturer TWISTER Softwareversion 1 19 Page 44 of 46 Version 1 19 4 2010 05 31 Repairs are allowed to be done by the manufacturer only Changing the Power Fuses of the TWISTER stimulator The fuses are located at the rear side of the TWISTER stimulator power module The fuses must be substituted by fuses of the same type and with the same required specifications Fuses with higher current values can cause a TWISTER
3. MHz to 2 5 GHz d 1 2VP 800 MHz to 2 5 GHz 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 then the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol at NOTE 1 At 80 MHz and 800 MHz tha 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 strength from fixed transmitter 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 electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered if the measured field strength in the location m which the nerve stimulator TWISTER is used exceeds the applicable RF compliance level above the nerve stimulator TWISTER should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the nerve stimulator TWISTER gt Over the freq
4. an electrical safety check on a regular time frame Caution Needle electrodes should be applied as far as possible away from the electro surgery devices to avoid burns caused by induced currents in result from radio frequency fields Thus the electro surgery device should not be placed close to the patient s head or neck in case of a surgery All cables of these devices should be placed as far away as possible from other electrode cables particularly using monopolar instruments TWISTER Softwareversion 1 19 Page 6 of 46 Version 1 19 4 2010 05 31 Before starting surgery the risk of injuries of the nerves to be examined as well as burns caused by interactions between electro surgical devices and the TWISTER nerve stimulator should be balanced Only those needle electrodes are allowed to be used which are approved for use with TWISTER by the manufacturer In case non sterile electrodes are used with TWISTER the needle electrodes must be sterilized Before using the needle electrodes the user s instructions and in case of reusable electrodes the manufacturer s sterilization directives have to be studied carefully and followed up The same applies to the use of stimulation probes accordingly Only those stimulation probes provided by the manufacturer are allowed to be used The stimulation probes must be sterilized before each use following the user s instructions and manufacturer s sterilizatio
5. electromagnetic environment specified below The customer or the user of the nerve stimulator TWISTER should assure that it is used in such an environment Immunity IEC 60601 Compliance level Electromagnetic environment test test level guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete ESD or ceramic tile If floors are IEC 61000 4 2 8KV air 8 kV air covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV 2kV Mains power quality should be transient burst for power supply lines for power supply lines that of a typical commercial or hospital environment IEC 61000 4 4 1kV 1kV for input output lines for input output lines Surge 1kV 1kV Mains power quality should be IEC 61000 4 5 differential mode differential mode that of a typical commercial or hospital environment 2kV 2kV common mode common mode Voltage dips short lt 5 Ur lt 5 Ur Mains power quality should be interruptions and for 0 5 cycle for 0 5 cycle that of a typical commercial or voltage variations on gt 95 dip in Ur gt 95 dip in Ur hospital environment If the user power supply input of the nerve stimulator lines 40 Ur 40 Ur TWISTER requires continued for 5 cycle for 5 cycle operation during power mains IEC 61000 4 11 60 dip in Ur 70 Ur for 25 cycle 30 dip in Ur lt 5 Ur for 5 sec gt 95 dip in
6. footswitch mode The blue button To start and stop the stimulation Starting the stimulation will cause the equenc a en E Sequency J 4 50 E Pulsewidth us 100 0 75 0 Energy mJ 0 50 0 Stimulation Current m 25 0 0 0 urrent m 25 0 Ci 50 0 75 0 100 0 dc S e d 1 887 5 kOhm aa Edit Burst Shape Pulse pleat shape Figure 14 Running stimulation During stimulation the system calculates the pulse energy When the pulse energy exceeds the maximum limit of 50 mJ the stimulation pulses are no longer transmitted to the patient electrodes The pulse graph display continues to run but the indicator for pulse energy at the right side of the main window starts flashing Figure 15 Additionally a beep tone indicates this warning Energy mJ EGA Stimulation Current m 100 0 Figure 15 Flashing energy display in case of overshooting maximum pulse energy TWISTER Softwareversion 1 19 Page 25 of 46 Version 1 19 4 2010 05 31 Furthermore the selected stimulation frequency is verified compared to the configured pulse width In burst or pulse shape mode the pulse width includes all pulses or the complete shape respectively If the frequency is chosen too high there is not enough time to generate complete pulses and to separate them from each other In this case the frequency control starts flashing Figure 16 and an acoustic warning can be heard
7. i CH Lo Energy mJ 0 50 0 100 R Stimulation Current mA p2 T 25 0 50 S m gE i 8 5 P3 a 25 0 50 5 Led 50 0 100 l P4 75 0 150 100 0 200 P5 0 050 s kohm 19 5 Edit Select Foot Help Einzel Burst Shape Pulse Pulse switch Quit shape shape Figure 16 Stimulation frequency is too high to stimulate complete pulse shapes the frequency display flashes If the PC performance is too low to control the stimulator TWISTER an error message appears Figure 17 If this message continuous to appear after all other applications have been closed the PC is not suitable for this application cp chapter 16 PC performance requirements TWISTER Softwareversion 1 19 Page 26 of 46 Version 1 19 4 2010 05 31 This message can also appear immediately after the PC was switched on if other programs running in the background or system services consume too much CPU performance Wait a moment before starting the first stimulation in this case C Attention Figure 17 System performance too low Quit Quit the TWISTER application program 5 2 Main window indicators Energy mJ Pulse energy display during a running stimulation If the value exceeds 50 mJ the stimulation will be discontinued and the display flashes kOhm Electrode impedance display The display is blank if the signal amplitudes are too small or if the signal is disturbed A value is calculated only during stimulat
8. is finally selected by the software To trigger an external monitoring device a connection between the trigger output at the rear side of the TWISTER to the trigger input of the external monitoring device has to be established Optionally an external footswitch can be connected at the rear side of the device The footswitch is used to fire single pulses Now the TWISTER PC software can be started After a correct installation the green LED light PC Link at the front side of the TWISTER indicates a correct operation TWISTER Softwareversion 1 19 Page 13 of 46 Version 1 19 4 2010 05 31 The program s main window opens Figure 1 and signalizes the correct operation of the system An error message will appear while programming the PC with non MS Windows 2000 Professional or MS Windows XP Professional system software upon confirmation of the error message the program will be aborted 100 0 75 0 0 50 0 Stimulation Current mA 25 0 t m 0 0 AEA 2o90 curren 50 0 75 0 100 0 1 887 s Edit Select ze Pulse Pulse shape shape Figure 1 Main window If the TWISTER is not connected to the power supply or not switched on the following error message appears Figure 2 attention gt xi Twister is switched off or power supply not connected Do you want to quit the program Figure 2 Error message TWISTER not connected to the power supply or switched off TWI
9. medical specialists evaluates the potential risks and performs the examination In all these cases a qualified medical specialist has to be consulted Disturbances affecting the safety have to be eliminated immediately TWISTER Softwareversion 1 19 Page 34 of 46 Version 1 19 4 2010 05 31 Stimulation current densities higher than 2mA effectively cm require the particular attention of the operator or user The device should not be used at locations of high humidity Electrodes are not allowed to be applied contralateral at the head or chest i e simultaneously at different parts of the human body e g at the right and left arm or close to skin injuries TWISTER must not be used for cardiac stimulation The current source of the TWISTER device is able to deliver electrical pulses of 10 mA effectively averaged over a time period of 5 s at a resistance of 1000 Ohms Because of TWISTER being a current source it provides in case of a bad electrode impedance voltages of up to 200 Volts at the electrode output Thus attention has to be paid to reach a low electrode impedance The electrode impedance has to be checked before applying currents gt 20 mA The impedance value must be less than 5000 Ohms The electrodes must not be applied during stimulation If a stimulation pulse is applied to the patient unexpected muscle tremors can occur To avoid the risk of injuri
10. side you can also find two buttons labelled with arrows They have the same functionality as the double arrow buttons in the software interface Holding down the buttons for a long time increases or decreases the current continuously A time delay prevents rapid current changings 1 5 Figure 8 Stimulation current controls Because of safety reasons the stimulation current is set to 1 5 mA after starting the software or a new program The maximum current value can be configured and stored together with the selected program It is displayed in the yellow line above the signal graph Figure 7 TWISTER Softwareversion 1 19 Page 20 of 46 Version 1 19 4 2010 05 31 With the controls located at the left side Figure 9 complete configurations can be stored and opened when required by a click on the desired program key Figure 9 Controls to store and call complete configurations To store the current configuration push the lt Store gt button first and then the desired program key lt P1 P5 gt To open a stored configuration directly click the desired program key lt P1 P5 gt A program name can be edited in the yellow range Program Figure 5 above the signal graph before a program is stored It helps to identify the program TWISTER Softwareversion 1 19 Page 21 of 46 Version 1 19 4 2010 05 31 The controls in the lower part of the main window Figure 10 contain the main functions of the stimulator TWISTER
11. stimulator device damage 15 Accessories Please consider the accessories catalogue of the Dr Langer Medical GmbH for detailed information on stimulation probes needle electrodes and adhesive surface electrodes as well as connecting cables and other accessories 16 PC performance requirements Operating system Windows 2000 Prof or Windows XP Prof Available USB Link USB 1 0 HDD free space minimum 200 MB RAM memory minimum 256 MB CPU speed minimum 800 MHz The PC must feature a built in sound adapter The devices connected to TWISTER must comply with EN950 at least Caution TWISTER must not be used together with other devices using the same multiple socket outlet TWISTER Softwareversion 1 19 Page 45 of 46 Version 1 19 4 2010 05 31 17 Manufacturer address DR LANGER MEDICAL Dr Langer Medical GmbH Fabrik Sonntag Haus 4a 79183 Waldkirch Germany Phone 49 0 7681 47 454 0 Fax 49 0 76 81 47 45 4 29 http www neuromonitoring eu info neuromonitoring eu TWISTER Softwareversion 1 19 Page 46 of 46 Version 1 19 4 2010 05 31
12. 19 Page 31 of 46 Version 1 19 4 2010 05 31 OK Closing the pulse shape editor accepting the existing pulse shape The shape is displayed in the pulse preview in the main window Cancel Closing the pulse shape editor and discarding the selected pulse shapes The status in the main window will be the one before the pulse shape editor was opened Help Help window with short instructions If pulse shape is selected as pulse type and no pulse shape is chosen empty pulse preview an error message will appear Figure 21 Choose or generate a pulse shape and start the stimulation again Attention Figure 21 Pulse shape chosen as pulse type but no shape selected TWISTER Softwareversion 1 19 Page 32 of 46 Version 1 19 4 2010 05 31 6 Basic safety instructions 6 1 Follow all instructions in the instructions for use Basic requirement for the correct operation and handling of the nerve stimulator TWISTER as well as the failure free function is the detailed knowledge of the basic safety requirements and standards This users manual contains the most important advices to operate the nerve stimulator TWISTER according to the safety requirements and standards This users manual and particularly the safety instructions have to be followed by all users working with the nerve stimulator TWISTER Additionally all locally valid safety instructions and requirements to avoid harms have to be followed 6 2 Operator obligatio
13. Nerve stimulator TWISTER INSTRUCTIONS FOR USE Softwareversion 1 19 C 0535 Manufacturer Dr Langer Medical GmbH Fabrik Sonntag Haus 4a 79183 Waldkirch Germany Table of contents THATS ROIS Ci oes cocci eee pence a cde cc eee te ae eee 5 2 COMMON ele 6 J pell Eech 8 3 1 Geier 8 3 2 TWISTER USB driver Instaletton 8 3 3 Soundiinierace Setup EE 9 4 Functional principals and operation 22 inna avec ten caw tea eee 10 4 1 teuer EE 11 4 2 Control outputs and inputs at the rear side of the device ee eeeeeeeeestteeeeeeees 12 4 2 1 Description of the combination with third party devices sssssseeeeeeesseeee 12 AS EE 13 Aa TWISTER DEE 17 5 TWISTER EES 18 5 1 Main Window eut 18 5 2 Main LEIDER eege ee ege eege Ee 27 5 3 P lse SNAPE e re EE 28 5 3 1 Drawing a new pulse shape EE 29 5 3 2 Changing an existing pulse happen 31 6 Basic safety instructions eebe ee ee eege 33 6 1 Follow all instructions in the instructions for use cceeeeeeeeeeeeeeeeeeeeeeeeeteeeeeeeees 33 6 2 Operator obligati Ms geg eegene Ee 33 6 3 User ODIIG ANON EE 33 6 4 Dangers using the TWISTER stimulator c ccsccesccseseesesesesessesesestsesesessesessesees 34 6 5 Preventing electromagnetic interferences e 40 6 6 Warranty and WAY EE 40 FE ee Le EE 41 7 1 Symbols and declarations 22 3 sok deed Hee ees 41 7 2 Informal safety MEASUIES EEN 41 7 3 Personnel training EEN 41 7 4 Safety measures duri
14. O mode by pushing the lt Demo gt button This mode shows you a flashing message Demo Mode at the bottom of the main window Figure 5 To leave the demo mode the software must be closed by pushing the lt Quit gt button and restarted afterwards Energy mJ 0 Stimulation Current mA 100 0 __Demo Mode 1 oer ree Edit Select Help Burst Shape Pulse Pulse shape shape Figure 5 Demo mode TWISTER Softwareversion 1 19 Page 16 of 46 Version 1 19 4 2010 05 31 4 4 TWISTER shut down TWISTER has to be switched off as follows The device is switched off using the power switch at the rear side of the device The green Power LED light is turned off If the PC is still switched on the green PC Link LED remains on This function can be compared to a sleep mode By switching off the PC or disconnecting the USB link cable the TWISTER is switched off completely TWISTER Softwareversion 1 19 Page 17 of 46 Version 1 19 4 2010 05 31 5 TWISTER operation 5 1 Main window controls The main window is divided in several control groups Figure 6 shows the controls to setup the pulse shapes for single and burst stimulation the stimulation frequency as well as the controls for sequential stimulation Frequency Hz Pulsenumber c 5 3 3 5 Sequency P Pulsewidth us ISI ms Stimulations a 1 50 positive Channel Break s T B 4 5 Figure 6 Controls i
15. STER Softwareversion 1 19 Page 14 of 46 Version 1 19 4 2010 05 31 Connect the power cable to the power supply and switch the TWISTER device on After clicking the lt No gt button the error message will disappear With lt Yes gt the program can be closed If the USB device driver is not properly installed at the PC or if the USB link cable is not connected or if the PC does not have a built in sound board the following error message appears Figure 3 Attention Figure 3 Incorrect USB device driver installation or USB link cable not properly connected Connect if applicable the USB link cable to the connector at the rear side of the TWISTER and to the PC s USB connector Then push the lt No gt button and the error message will disappear If the error message continues to appear contact the customer service of Dr Langer Medical GmbH If an error message according to Figure 4 appears you have to adjust the PC s audio setup Attention Figure 4 Configuration error in the audio and multimedia setup TWISTER Softwareversion 1 19 Page 15 of 46 Version 1 19 4 2010 05 31 Therefore check the configurations made according to chapter 3 3 Sound interface setup If necessary redo the sound interface setup If the error message continues to appear contact the customer service of Dr Langer Medical GmbH If TWISTER is not connected to the PC via the USB link cable the TWISTER software can be started in DEM
16. Ur 60 dip in Uz 70 Ur for 25 cycle 30 dip in Ur lt 5 Ur for 5 sec gt 95 dip in Ur interruptions it is recommended that the nerve stimulator TWISTER be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level TWISTER Softwareversion 1 19 Page 38 of 46 Version 1 19 4 2010 05 31 Guidance and manufacturer s declaration electromagnetic immunity The nerve stimulator TWISTER is intended for use in the electromagnetic environment specified below The customer or the user of the nerve stimulator TWISTER should assure that it is used in such an environment Immunity IEC 60601 Compliance electromagnetic environment Guidance test test level level Portable and mobile RF Communications equipment should be used no closer to any part of the nerve stimulator TWISTER including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 d 1 2VP MHz Radiated RF 3 V m 3 V m d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80
17. With a sequential stimulation an additional display Sequence Status will appear with pulse number and break time in seconds Figure 7 Figure 7 Controls to setup sequential stimulation A stimulation with frequencies less than lt 1Hz can be configured in sequential mode Choose 1 in the field lt Stimulations gt The value in the field lt Break s gt is the time period between two subsequent pulse sequences in the case of one stimulation between two subsequent single pulses Stimulations Number of stimulations in a stimulation sequence in the range of 1 2000 If the checkbox lt Sequence gt is not marked the sequence setup controls appear dimmed and disabled TWISTER Softwareversion 1 19 Page 19 of 46 Version 1 19 4 2010 05 31 Break s Time period between two subsequent stimulation sequences in the range of 1 300 seconds If the checkbox is not marked the lt Break s gt value is disabled and dimmed Thus the running sequence stops after the system has reached the number of stimulations the first time In the right part of the main window the controls for the stimulation current can be found The current can be changed in the range of 1 100 mA Figure 8 The controls labelled with arrows are used to increase or decrease stimulation current The double arrow buttons increase or decrease the stimulation current in steps of 1 mA single arrow buttons in steps of 0 1 mA At the TWISTER front
18. e multiple socket outlet No other TWISTER accessories than the TWISTER electrodes are allowed to be used within the patient s range Other accessories than those approved by the manufacturer are not allowed to be used Guidance and manufacturer s declaration electromagnetic emissions The nerve stimulator TWISTER is intended for use In the electromagnetic environment specified below The customer or the user of the nerve stimulator TWISTER should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance Kail RF emissions CISPR 11 Group 1 The nerve stimulator TWISTER uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Group B The nerve stimulator TWISTER must emit Harmonic emissions Not applicable electromagnetic energy in order to perform its IEC 61000 3 2 intended function Nearby electronic equipment Voltage fluctuations flicker Not applicable may be affected emissions IEC 61000 3 3 TWISTER Softwareversion 1 19 Page 36 of 46 Version 1 19 4 2010 05 31 Recommended separation distances between portable and mobile RF communications equipment and the nerve stimulator TWISTER The nerve stimulator TWISTER is intended for use in an electromagnetic environment in which radiated RF disturba
19. eeding use does not apply to the term intended use Dr Langer Medical GmbH is not liable for harms caused by a non intended use Please consider implicitly the notes mentioned in article 6 4 Dangers using the TWISTER stimulator The intended use is based on the compliance with the required service and maintenance intervals TWISTER Softwareversion 1 19 Page 5 of 46 Version 1 19 4 2010 05 31 2 Common notes The exact attention to the instructions for use is the main requirement for the intended use and the correct handling of the device and the resulting safety for the patient and the operator It is not allowed to use accessories not approved with the device by the manufacturer and not listed in the instructions for use In case of any use of accessories not listed in the instructions for use the technical and biological harmlessness has to be proved All printed documents comply with the delivered devices and the current safety standards when printed All rights are reserved for the mentioned devices circuitries methods software programs and names The use of needle electrodes together with electro surgery devices can cause an increased risk of burns at the contact between the electrode and the skin For this reason all advices and safety instructions of electro surgery devices have to be studied carefully and followed by the users In addition all devices measuring impedance or current have to undergo
20. es the environment should be chosen carefully Sharp edged items should not be placed close to the patient Unnecessary high stimulation currents should be avoided After having switched to another configuration or after having switched on the TWISTER device the stimulation current should be checked before starting stimulation TWISTER must not be used close to microwave devices or mobile phones TWISTER must not be used in explosive environments TWISTER must not be used in electromagnetic fields If an external monitoring device is used to acquire the stimulation response it has to be triggered by the TWISTER using a trigger cable The PC controlling the TWISTER must not run any audio software during TWISTER operation The simultaneous operation of TWISTER and a HF surgery equipment can cause burns at the electrodes Probably TWISTER can be damaged during simultaneous operation The miscellaneous contact between TWISTER electrodes and other conducting parts probes or electrodes of third parties must be avoided TWISTER Softwareversion 1 19 Page 35 of 46 Version 1 19 4 2010 05 31 TWISTER must not be used close to the patient according to the EN60601 1 1 which describes this range with distance to the patient at least 1 5m measured 2 5m from ground vertically above the patient TWISTER must not be used together with other devices using the sam
21. ion Online signal graph The signal graph shows the current and voltage signal during stimulation The scale colours show which scale belongs to which signal 10 Pulses are displayed every time regardless to the selected stimulation frequency The timescale will be adjusted according the selected stimulation frequency In the footswitch mode the time scale is set to 10 seconds TWISTER Softwareversion 1 19 Page 27 of 46 Version 1 19 4 2010 05 31 5 3 Pulse shape editor The pulse shape editor allows to configure pulse shapes graphically which exceed the standard configuration capabilities The pulse shape editor can be opened by pushing the lt Edit Pulse shape gt button in the main window Figure 18 To enable this button pulse shape must be selected as pulse type If a pulse shape does already exist it will be displayed in the pulse graph It can be changed or a new shape can be drawn C2 Twister 1 15 DS J pulseshape Editor T ZS Li m ke 3 2 Tri E Ka 80 100 1 1 I 1 I 1 0 00 0 10 0 20 O30 0 40 0 50 0 60 Time ms Time ms Amplitude Tor Max Time ms 0 00 Figure 18 Pulse shape editor TWISTER Softwareversion 1 19 Page 28 of 46 Version 1 19 4 2010 05 31 5 3 1 Drawing a new pulse shape Choose the desired total pulse width using the control lt Max Time ms gt range of 0 1 50 ms before starting to draw the shape Push the lt Draw gt button The button s background col
22. lation Current 4 Oi a Twister Increasing stimulation current Decreasing stimulation current Stimulation start stop single pulse in footswitch mode CH1 2 Connector for stimulation channels 1 and 2 CH3 4 Connector for stimulation channels 3 and 4 Power Power supply indicator switched on gt green Ready Stimulator is ready to deliver stimulation pulses yellow PC Link PC connected control software started green TWISTER Softwareversion 1 19 Page 11 of 46 Version 1 19 4 2010 05 31 4 2 Control outputs and inputs at the rear side of the device 230V AC 50Hz 17W Ms awit fz Seguranca Fuse 200 mA T Ge loder Su RR g A NE Class Compuls rio d Pmax 17 W Ci p Ser No TW 090 21 2010 Trigger Foot USB Host OUT switch G 0535 Connector A Power module Power switch to turn TWISTER on and off USB Host Connector USB cable connector to PC Footswitch External footswitch connector Trigger Out TTL trigger output for connection to third party monitoring systems 4 2 1 Description of the combination with third party devices A third party monitoring device can be triggered via Trigger Out The trigger out pulses are time synchronously with the stimulation pulses The trigger out pulse is fired with the first pulse in burst mode USB Host Connector The USB cable connecting TWISTER to the controlling PC is connected to this connector The controlling PC must meet the minimum require
23. mage is found Faulty devices or cables must not be used O The device and accessories have to be checked visually for functionally affecting damages The annual safety examination has to be done by the manufacturer or a person which has been authorized by the manufacturer 7 5 Constructional changes at TWISTER O Constructional changes and repairs are allowed to be done by the manufacturer only 8 Copy right The copy right of the user s manual is preserved by the Dr Langer Medical GmbH Waldkirch Germany 9 User s manual copying The user s manual must not be copied without the approval by the manufacturer TWISTER Softwareversion 1 19 Page 42 of 46 Version 1 19 4 2010 05 31 10 Technical data Weight about 2 kg Power consumption maximum 17 W Operating voltage 230V AC 50 Hz Dimensions cm 20 x 16cm x 80 mm L x H x W Cut off frequency measured at 1 kOhm at 20 mA 10 Khz Operating temperature 10 to 40 C Storage temperature 0 to 40 C Stimulation voltage 200 V Stimulation current 100 mA Pulse shapes positive negative alternating and free Pulse width 50 us 1 ms Stimulation frequency maximum 1000 Hz Impedance range at the tissue at which 100 mA can be reached Max 1800 Ohms Channels 1 of 4 Energy limitation 50 mJ for each single pulse measured at 1 kOhm TTL trigger output pulse width 200 us high active USB connector B Type meets USB 1 0 specification Power fuses
24. ments described in chapter 16 Footswitch A footswitch can be connected to this connector The Footswitch must comply with protection class IPX1 An approved footswitch can be purchased optionally from the manufacturer TWISTER Softwareversion 1 19 Page 12 of 46 Version 1 19 4 2010 05 31 4 3 TWISTER start up First start up The operator must not start up the device before the manufacturer or dealer has checked the correct device function at the customer s site has introduced the responsible users in the correct operation of the device TWISTER has to be started up as follows Use the power cable shipped with the device to connect it to the power supply The power supply connector can be found at the rear side of the device The TWISTER device can be switched on now The power switch is also located at the rear side of the device The green power LED at the front side indicates the correct operation The included USB link cable has to be connected to the USB Host Connector at the rear side of the TWISTER Regardless whether the controlling PC is switched on or off the USB link cable has to be connected to the PC The PC must have at least one unused USB link PCs w o USB connector cannot be used for TWISTER operation The stimulation cables are connected to the device s front side According to the desired stimulation channel one of the two patient output connectors have to be chosen The stimulation channel
25. n Custom Pattern pul Figure 12 Pulse shape selection The selected pulse shape is displayed in the pulse preview Figure 11 TWISTER Softwareversion 1 19 Page 23 of 46 Version 1 19 4 2010 05 31 Footswitch colour indicates the active footswitch mode By clicking the connected footswitch single pulses or pulse shapes can be fired Those controls which are not needed in this mode or which are not allowed to be changed are disabled and dimmed Figure 13 As soon as the footswitch mode is disabled by pushing the lt Footswitch gt button again these controls will be enabled again 5 3 4 5 Isewidth us d 200 4 1 Start Stop TWISTER Softwareversion 1 19 Page 24 of 46 Version 1 19 4 2010 05 31 Polarity positive F 1 100 0 75 0 Energy mJ 0 50 0 ees See Stimulation Current m 25 0 50 ZS 0 i gt g 4 5 i E 0 0 t T U j 25 0 aaa fe 50 0 75 0 100 0 10 000 s Edt l Fot Pulse Pulse switch Start Quit shape shape active Figure 13 Main window in footswitch mode button to change to green colour indicating a running stimulation The label will change to lt Stop gt Unnecessary controls or those which are not allowed to be changed during a running stimulation are disabled and dimmed Figure 14 Start stop can also be controlled by the START STOP labelled button at the front side of the TWISTER Pushing this button will enable the
26. n The operator is obliged to allow only those staff working with the stimulator TWISTER who are familiar with the TWISTER functionality and handling and who are instructed by the responsible personnel have read and understood the chapters Basic safety instructions Safety requirements and the warning notices in this user s manual 6 3 User obligation All persons working with the TWISTER stimulator are obliged before starting to work to follow the basic safety instructions to avoid dangers to patients or personnel TWISTER Softwareversion 1 19 Page 33 of 46 Version 1 19 4 2010 05 31 6 4 Dangers using the TWISTER stimulator The TWISTER stimulator is developed and built according to the current safety related standards Nevertheless certain risks for users or third parties can occur as well as damages on TWISTER The TWISTER stimulator is allowed to be used only for its intended use in acorrect state according to the safety standards The TWISTER stimulator is not allowed to be used if the patient has a cardiac pacemaker implant if the patient has an implanted cardiac defibrillator ICD if the patient suffers from heart rhythm dysfunction in case of pregnancy during intraoperative or diagnostic examinations if the patient suffers from epilepsy TWISTER is allowed to be used for specific examinations in the treatment of epilepsy when a qualified
27. n directives TWISTER Softwareversion 1 19 Page 7 of 46 Version 1 19 4 2010 05 31 3 Installation 3 1 Software installation Insert the TWISTER software CD into the CD Rom drive and follow the prompts of the installation wizard Please consider that during installation of the software the stimulator TWISTER may not be connected to the computer 3 2 TWISTER USB driver installation Please consider that for the USB driver installation the TWISTER has to be connected to the PC which controls TWISTER To install the USB driver for the nerve stimulator TWISTER some configurations in the Device Manager have to be modified The Device Manager can be opened by the follwing path START gt Control Panel gt System gt Tab Hardware gt Device Manager Enlarge Universal Serial Bus Controllers and choose Micronas USB Verbundgerat in the Device Manager Use the right click to choose Update Driver The Update Manager is opened Z Choose Yes this time only gt Click Next gt Choose Install from a specific list or specific location gt Click Next gt Choose Don t search will choose the driver to install gt Click Next gt Choose TWISTER HS gt Click Next gt follow the instructions to finish USB driver installation TWISTER Softwareversion 1 19 Page 8 of 46 Version 1 19 4 2010 05 31 3 3 Sound in
28. n the upper left part of the main window negative alternating Frequency Hz Stimulation frequency setup in the range of 1 1000 Hz Pulse width us Pulse width setup in the range of 50 1000 us Polarity Polarity setup of the rectangular stimulation pulse positive negative or alternating positive negative The pulse width in alternating mode is the value for each of the both polarities The complete pulse is thus twice the selected pulse width long Pulse number Pulse number setup in burst stimulation mode in the range of 2 10 This control is disabled and dimmed when single pulse or pulse shape is selected ISI ms Interstimulus interval setup in burst stimulation mode in the range of 1 200 ms The interstimulus interval is the break between two subsequent pulses in burst stimulation mode TWISTER Softwareversion 1 19 Page 18 of 46 Version 1 19 4 2010 05 31 Channel Stimulation channel setup in the range of 1 4 Please check the correct connection of the stimulation output cable at connector 1 CH1 2 for channel 1 or 2 or connector 2 CH3 4 for the channels 3 or 4 at the front side of the TWISTER Sequence Switching sequential stimulation on or off In this mode the selected number of stimulation pulses will be fired Afterwards the stimulation pauses for the preselected time and will be restarted automatically again This mode of stimulation is particularly suitable for SEP
29. nces are controlled The customer or the user of the nerve stimulator TWISTER can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the nerve stimulator TWISTER as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m Ww 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 23 10 3 8 3 8 7 3 100 12 12 23 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 TWISTER Softwareversion 1 19 Page 37 of 46 Version 1 19 4 2010 05 31 Guidance and manufacturer s declaration electromagnetic immunity The nerve stimulator TWISTER is intended for use in the
30. ng normal operation cccceeeeeeeeeeeeeeeeeeeeeeeeteeeeeeeeeeeeeees 42 7 5 Constructional changes at TWISTERT 42 TWISTER Softwareversion 1 19 Page 3 of 46 Version 1 19 4 2010 05 31 10 11 12 13 14 15 16 17 EIERE 42 User s manual copying DE 42 E ees E 43 Serial Ralinger e E 44 Disposal Ot waste EEN 44 Cleaning Pasar eee ee rene e eer rea ere PR te a err ere en oe 44 Service and EE 44 ee EE 45 PC performance requirements EEN 45 Ee ee e 46 TWISTER Softwareversion 1 19 Page 4 of 46 Version 1 19 4 2010 05 31 1 Intended use TWISTER is a freely programmable electrical nerve stimulator to evoke biopotentials on the human body TWISTER is connected to a PC via USB link The USB link is not considered application part B and BF It is double isolated from the patient outputs and power supply The controlling PC does not need a medical isolation TWISTER has 4 stimulation outputs Each channel can be selected via software The pulse intensity can be controlled by the software or by the quick access buttons at the front panel The TWISTER operating user must be trained and familiar with the impacts of electrical stimulation to the human body In addition to standard pulses the operator can configure and store pulse shapes graphically Thus the stimulator TWISTER can also be used for special diagnostic purposes at human beings TWISTER has been developed for nerve stimulation only A different or exc
31. onality AN Type BF applied part stimulation cable Symbol indicates the conformance with the appropriate EU directives 0535 Identification number if the notified body EUROCAT Institute for Certifiaction and Testing GmbH Darmstadt Consult the manual before use O1 LA Oo The required personnel safety equipment has to be provided by the operator All existing safety equipment has to be checked at regular intervals 7 2 Informal safety measures The user s manual has to be kept at the place of installation All harms and dangers as well as the safety instructions must be kept in a readable state 7 3 Personnel training The responsibility of the personnel for the installation initial operation operation and maintenance have to be clearly established TWISTER Softwareversion 1 19 Page 41 of 46 Version 1 19 4 2010 05 31 7 4 Safety measures during normal operation Visual inspection and functional test prior to operation The TWISTER stimulator is allowed to be used only if all safety devices protective earth connection are functioning correctly The inspection of the internal safety devices is part of the annually required safety examination O The operator has to check the correct functionality of the device and the correct status of the device and all accessories before each use O External damages on isolation plugs and housing have to be checked visually The device must not be used if any da
32. our changes to green and the lt New gt button changes to enabled state allowing to delete existing pulse shapes from the pulse graph and to start with a new drawing Start to draw using the left mouse key and moving the mouse over the black area of the pulse graph The values for amplitude and time at the mouse position can be checked with the indicators for Time ms and Amplitude Fix each end point of your desired pulse shape with a mouse click Move the mouse cursor to the right only drawing to the left is not possible You can always extend the total pulse width by changing the value in the Max Time ms control After clicking the last point Figure 19 the pulse shape can be stored together with a name helping to identify it using the lt Save gt button This key is disabled if no pulse shape exists in the pulse graph area 4 pulseshape Editor Amplitude 1 1 I I I 0 30 O40 O 50 D n O 70 0 80 Time ms Time ms Amplitude Max Time ms loss e 1 00 ls Figure 19 Drawn pulse shape TWISTER Softwareversion 1 19 Page 29 of 46 Version 1 19 4 2010 05 31 e The amplitude of the pulse shape is defined as a value between 100 100 During stimulation it is the percentage of the selected stimulation current in the main window cp Figure 8 Example Amplitude value in pulse shape 80 Selected stimulation current in main window 20mA Amplitude value in pulse sha
33. pe selected stimulation current in main window mA Stimulated current mA The stimulated current is 16mA in this case TWISTER Softwareversion 1 19 Page 30 of 46 Version 1 19 4 2010 05 31 5 3 2 Changing an existing pulse shape e If the lt Draw gt button is pushed again and a pulse shape exists in the pulse graph the lt Adjust gt button becomes enabled otherwise it is disabled and dimmed Push the lt Adjust gt button to change an existing pulse shape The button s background changes to green colour Figure 20 As soon as you Click close to the point you want to change in the pulse graph area the shape s colour changes to green indicating that it is in adjust mode The selected point can be changed in its time and amplitude by moving the mouse now By a left mouse click the point is fixed in its new position the shape s colour changes to blue again The pulse shape can also be extended to the right by changing the value in the control lt Max Time ms gt 4 pulseshape Editor 100 New Draw Amplitude 20 40 60 80 100 7 1 1 1 0 00 0 10 0 20 0 30 0 40 0 50 Time ms 1 H 0 60 0 70 0 80 0 90 1 00 Sam Time ms Amplitude Max Time ms 0 84 84 1 00 em Figure 20 Changing an existing pulse shape Naag D e By pushing the button lt Open gt stored waveform files for further operation can be opened TWISTER Softwareversion 1
34. terface setup For correct audio playback the sounds and audio devices have to be reconfigured Therefore switch to START gt Control Panel gt Sounds amp Audio Devices gt Tab Audio For sound playback the internal sound card must be set as default device NOT TWISTER HS For sound recording the internal sound card must be set as default device NOT TWISTER HS Please checkmark the box for Use only default devices TWISTER Softwareversion 1 19 Page 9 of 46 Version 1 19 4 2010 05 31 4 Functional principals and operation The maximum voltage is 200 Volts The operational indicator READY at the front panel of the TWISTER shows that the TWISTER is ready to deliver stimulation pulses The electrode output is twice isolated against power supply and the control unit consisting of the trigger output footswitch input and USB link and thus potential free Only those electrodes approved by the Dr Langer Medical GmbH are allowed to be connected to the electrode output The stimulation current density must not exceed 2 mA cm Energy limitation TWISTER monitors the energy delivered to the electrodes The energy is measured at a 1000 Ohm resistance and limited to a maximum of 50 mJ The exceeding will be signalized by the software TWISTER Softwareversion 1 19 Page 10 of 46 Version 1 19 4 2010 05 31 4 1 Front side description v Ri A _ ILL Ready Power PC Link Stimu
35. uency range 150 kHz to 80 MHz field strengths should be less than 3 V m TWISTER Softwareversion 1 19 Page 39 of 46 Version 1 19 4 2010 05 31 6 5 Preventing electromagnetic interferences Electromagnetic field disturbances caused by HF surgery equipment can be reduced or eliminated by locating the TWISTER device as far away as possible from the HF surgery device 6 6 Warranty and liability The warranty includes only material Warranty claims and liability for physical and material damages exist only if the receiver user proves that the following rules have been kept J Intended use of the TWISTER stimulator CT Appropriate installation transport storage start up operation and maintenance according to the user s manual and all safety requirements and standards J No arbitrary constructive changes at the nerve stimulator TWISTER No arbitrary services or repairs repairs have to be done by the manufacturer only J No influence of foreign objects The liability for consequential damages is excluded in either case TWISTER Softwareversion 1 19 Page 40 of 46 Version 1 19 4 2010 05 31 7 Safety instructions 7 1 Symbols and declarations The following terms and symbols were used in the instructions manual to indicate danger Caution Requires the particular attention of the user Caution Indicates the danger for system parts or a possible impairment of the TWISTER stimulator s functi
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