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Dr. Langer Medical TWISTER, Instructions For Use Manual

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Dr. Langer Medical TWISTER Instructions For Use Manual Download Page 34

 

TWISTER

®

 Softwareversion 1.19 

Page 34 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 a correct 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 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! 

 

 

Summary of Contents for TWISTER

Page 1: ...Nerve stimulator TWISTER INSTRUCTIONS FOR USE Softwareversion 1 19 Manufacturer Dr Langer Medical GmbH Fabrik Sonntag Haus 4a 79183 Waldkirch Germany ...

Page 2: ......

Page 3: ...TER shut down 17 5 TWISTER operation 18 5 1 Main window controls 18 5 2 Main window indicators 27 5 3 Pulse shape editor 28 5 3 1 Drawing a new pulse shape 29 5 3 2 Changing an existing pulse shape 31 6 Basic safety instructions 33 6 1 Follow all instructions in the instructions for use 33 6 2 Operator obligation 33 6 3 User obligation 33 6 4 Dangers using the TWISTER stimulator 34 6 5 Preventing ...

Page 4: ...1 19 4 2010 05 31 8 Copy right 42 9 User s manual copying 42 10 Technical data 43 11 Serial number design 44 12 Disposal of waste 44 13 Cleaning 44 14 Service and repair 44 15 Accessories 45 16 PC performance requirements 45 17 Manufacturer address 46 ...

Page 5: ...he 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 ...

Page 6: ... 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 ...

Page 7: ...anufacturer 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 man...

Page 8: ...ols 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 Control Panel System Tab Hardware Device Manager Enlarge Universal Serial Bus Controllers and choose Micronas USB Verbundgerät in the Device Manager Use the right click to choose Update Driver The Update Man...

Page 9: ...udio devices have to be reconfigured Therefore switch to START Control Panel Sounds Audio Devices 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 ...

Page 10: ...ed 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...

Page 11: ...ng 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 green Ready Stimulator is ready to deliver stimulation pulses yellow PC Link PC connected control software started green ...

Page 12: ...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 requirements described in cha...

Page 13: ...tor 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 ...

Page 14: ...hile 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 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 Figure 2 Error message TWISTER not connected to the power supply or switched off ...

Page 15: ... in sound board the following error message appears Figure 3 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 No button and the error message will disappear If the error message continues to appear contact the customer servi...

Page 16: ...ontinues 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 DEMO mode by pushing the Demo 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 Quit button and restarted afterw...

Page 17: ...ws 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 ...

Page 18: ... Pulse width µs Pulse width setup in the range of 50 1000 µs 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...

Page 19: ...automatically again This mode of stimulation is particularly suitable for SEP 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 1Hz can be configured in sequential mode Choose 1 in the field Stimulations The value in the field...

Page 20: ...se 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 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 continuous...

Page 21: ...esired program key Figure 9 Controls to store and call complete configurations To store the current configuration push the Store button first and then the desired program key P1 P5 To open a stored configuration directly click the desired program key P1 P5 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 pr...

Page 22: ...s 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 prog...

Page 23: ...e the Select Pulse shape button appears enabled and active Status Display Performance With the key combination Ctrl Shift F1 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 Figure 12 Pulse shape selection The selected pulse shape is displayed in the pulse preview Figure ...

Page 24: ...ed Figure 13 As soon as the footswitch mode is disabled by pushing the Footswitch button again these controls will be enabled again Figure 13 Main window in footswitch mode Start Stop To start and stop the stimulation Starting the stimulation will cause the button to change to green colour indicating a running stimulation The label will change to Stop Unnecessary controls or those which are not al...

Page 25: ...gy 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 Figure 15 Flashing energy display in case of overshooting maximum pulse energy ...

Page 26: ...erate 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 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 ap...

Page 27: ...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 stimulation Online signal graph The signal graph shows the current and voltage signal during stimulation The scale colours show which s...

Page 28: ...exceed the standard configuration capabilities The pulse shape editor can be opened by pushing the Edit Pulse shape 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 Figure 18 Pulse shape editor ...

Page 29: ...t 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 ...

Page 30: ...ring 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 shape selected stimulation current in main window mA Stimulated current mA 100 The stimulated current is 16mA in this case ...

Page 31: ...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 ch...

Page 32: ...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 Figure 21 Pulse shape chosen a...

Page 33: ... 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 obligation The operator is obliged to allow only those staff working with the stimulator TWISTER who are familiar with the TWISTER s functionality and handling and who are instructed by th...

Page 34: ... 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...

Page 35: ...e 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 injuries 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...

Page 36: ...gnetic 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 RF emissions CISPR 11 Group 1 The nerve stimulator TWISTER uses RF energy only for its internal function Theref...

Page 37: ...ns equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 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 ...

Page 38: ...ge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT for 0 5 cycle 95 dip in UT 40 UT for 5 cycle 60 dip in UT 70 UT for 25 cycle 30 dip in UT 5 UT for 5 sec 95 dip in U...

Page 39: ... m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less then the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 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 a...

Page 40: ...ims and liability for physical and material damages exist only if the receiver user proves that the following rules have been kept Intended use of the TWISTER stimulator Appropriate installation transport storage start up operation and maintenance according to the user s manual and all safety requirements and standards No arbitrary constructive changes at the nerve stimulator TWISTER No arbitrary ...

Page 41: ...h the appropriate EU directives 0535 Identification number if the notified body EUROCAT Institute for Certifiaction and Testing GmbH Darmstadt Consult the manual before use 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 insta...

Page 42: ... each use External damages on isolation plugs and housing have to be checked visually The device must not be used if any damage is found Faulty devices or cables must not be used 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 Cons...

Page 43: ...o 40 C Stimulation voltage 200 V Stimulation current 100 mA Pulse shapes positive negative alternating and free Pulse width 50 µs 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 µs high active USB connector B Type ...

Page 44: ...ing 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 ...

Page 45: ...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 ...

Page 46: ... 46 of 46 Version 1 19 4 2010 05 31 17 Manufacturer address Dr Langer Medical GmbH Fabrik Sonntag Haus 4a 79183 Waldkirch Germany Phone 49 0 76 81 47 45 4 0 Fax 49 0 76 81 47 45 4 29 http www neuromonitoring eu info neuromonitoring eu ...

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