MAGSTIM 3190-00 Скачать руководство пользователя страница 25

 

Magstim 2nd Generation Coils 

 

 

Operating Manual 

 

© The Magstim Company Limited 

22 

MOP04-EN-03 

APPENDIX B

 

-

 

TMS MEDICAL SCREENING QUESTIONNAIRE

 

The Magstim Company Limited takes your health and safety very seriously and as such, it is necessary to point out that there 
is  a  remote  possibility  of  adverse  effects  occurring  as  a  result  of  receiving  Transcranial  Magnetic  Stimulation  (TMS).    Such 
effects can include a risk of seizure, headache, pain and nausea in particular susceptible individuals.  We therefore kindly ask 
that  you  complete  the  following  medical  questionnaire,  answering  each  question  accurately.    Please  read  each  question 
carefully and if you have any doubt as to how to answer any question please tick ‘yes’ 
 

No. 

QUESTION 

YES 

NO 

DON’T 

KNOW 

COMMENTS 

1.11,     1. 

Do  you  have  epilepsy  or  have  you  ever  had  a 
convulsion or a seizure?

 

 

 

 

 

2222     2. 

Does  any  first  degree  member  of  your  family  have 
epilepsy? 

 

 

 

 

3. 
 

Have you ever had a fainting spell? 

 

 

 

 

 

4. 

Have  you  ever  had  severe  (i.e.,  followed  by  loss  of 
consciousness) head trauma?

 

 

 

 

 

5. 

Do you have any hearing problems or ringing in your 
ears?  (Advise  earplugs  must  be  worn  as  possible  risk 
of temporary tinnitus) 

 

 

 

 

6. 

Are  you  pregnant  or  is  there  any  chance  that  you 
might be?

 

 

 

 

 

7. 

Do  you  have  metal  in  the  brain/skull  (except 
titanium)? (e.g. splinters, fragments, clips, etc.)

 

 

 

 

 

8. 

Have you had surgery in the last 12 months above the 
neck? 

 

 

 

 

9. 

Do you have a cochlear implant?

 

 

 

 

 
 

10. 

Do  you  have  an  implanted  neurostimulator?  (e.g., 
DBS, epidural, subdural, VNS)

 

 

 

 

 

11. 

Do you have a cardiac pacemaker or intracardiac lines 
or metal in your body?

 

 

 

 

 

12. 

Do you have a medication infusion device?

 

 

 

 

 
 

13. 

Are you taking any medications such as anti-
depressants, psychoactive, neurological, psychiatric, 
recreational drugs? 

 

 

 

 
 

14. 

Have you consumed alcohol within the last 12 hours?  
(Please use the guidelines in the Procedure if answer is 
yes). 

 

 

 

 

15 

Have  you  ever  have  a  surgical  procedure  to  your 
spinal cord? 

 

 

 

 
 

16. 

Do you have spinal problems? 

 

 

 

 
 

17. 

Have  you  undergone  TMS  in  the  past  and  had  any 
adverse affects? 

 

 

 

 
 

18. 

Have you had a reasonable night’s sleep? 

 

 

 

 
 

 

 

 

 

Содержание 3190-00

Страница 1: ...FEB 2015 Magstim 2nd Generation Coils Operating Manual MOP04 EN Revision 03...

Страница 2: ...nterface 6 Section 4 Operating Instructions 9 4 1 Preparation 9 4 2 Connection 9 4 3 Operation 10 4 4 Interlocks 13 4 5 Error Codes 13 Section 5 Maintenance 14 5 1 User Maintenance and Calibration 14...

Страница 3: ...ng normal service Claims for damages during shipment must be filed promptly with the transportation company All correspondence concerning the equipment must specify the model name and or number as wel...

Страница 4: ...Magstim 2 nd Generation Coils are portable medical devices intended for limited patient exposure The coils are not intended to come into contact with any bodily fluids USA Only Federal law restricts...

Страница 5: ...egarding these devices The stimulator operating manual reference numbers are shown on the following page Magstim Rapid stimulator MOP03 Magstim 200 stimulator MOP01 Magstim BiStim stimulator MOP02 1 4...

Страница 6: ...ced in cables or wires that are directly connected to the subject must not be used in the vicinity of objects that are sensitive to magnetic fields such as watches credit cards and electronic equipmen...

Страница 7: ...for the use of TMS in clinical practice and research by Rossi et al 2009 in respect to screening candidates prior to administering TMS Environmental Conditions The system must not be used or stored u...

Страница 8: ...at flows through the winding generates a magnetic field and a corresponding electrical field as shown in Section 6 2 1 Figure 3 1 Example Coil illustration 3190 00 D70mm Remote Control Coil 3 2 Double...

Страница 9: ...e current direction to be changed when required by flipping the coil Figure 3 4 90mm Remote Control Coil P N 3192 00 Figure 3 5 90mm Standard Coil P N 3193 00 3 4 2nd Generation Coil User Interface 3...

Страница 10: ...ty interlock to disable them could result in a serious injury as a result of an inadvertent discharge of the coil 3 4 1 2 Stop Button 2 Engaging the stop button will place the stimulator into stopped...

Страница 11: ...its handle The roles of the interlock buttons are to prevent inadvertent triggering of the system Note On no account must either of the multi function buttons on the stimulating coil be permanently a...

Страница 12: ...and to identify any cleaning required If any cracks are visible in the plastic covers or there is damage to the handle or cable the coil must not be used and should be returned to The Magstim Company...

Страница 13: ...is connected to the stimulator and ready to use remove the coil from the coil holder of the right hand side of the stimulator The coil will show the output power of the system on the multi function d...

Страница 14: ...the selected parameter to the desired level The parameter value will be displayed on the stimulator user interface 3 To select a different parameter engage one of the multi function buttons twice in...

Страница 15: ...ulator 8 Section 4 2 should be repeated in reverse to disconnect the coil Note Ensure that the system is disarmed prior to disconnecting the stimulating coil from the stimulator 4 3 4 Use of the Stand...

Страница 16: ...tion There is an automatic coil temperature interlock applied by the stimulator When the maximum temperature is reached the coil temperature indicator will be illuminated and the stimulator will retur...

Страница 17: ...further advice or to arrange a return see Section 7 2 for contact details Warning contact burning is communicable so any coil with damaged contacts will infect a stimulator with healthy contacts and v...

Страница 18: ...serviceable life it should not be disposed of in general waste The Magstim Company Limited should be contacted see Section 7 2 for contact details for advice on its disposal in compliance with the app...

Страница 19: ...rent limits as required by IEC 60601 1 The Magstim 2 nd Generation Coils comply with the requirements of Safety Standard IEC 60601 1 and with EMC Standard EN 60601 1 2 To avoid problems with EMC inter...

Страница 20: ...verage Inductance 15 50 H 23 47 H 23 47 H Coil Cable Length 2m 2m 2m Peak Magnetic Field 2 2T 2 0T 2 0T Max Number of Pulses 50 Power 340 50 Power 505 50 Power 505 80 Power 110 80 Power 260 80 Power 2...

Страница 21: ...imited 18 MOP04 EN 03 Figure 6 2 Approximate electric field profile for D70mm Remote Coil measured using a Magstim Rapid 6 2 2 Magnetic Field Plot Figure 6 3 Approximate Magnetic Field Profile for 90m...

Страница 22: ...If for any reason it is necessary to return your Magstim 2 nd Generation Coils care should be taken to ensure that the equipment is adequately packed to prevent transit damage Ideally the equipment s...

Страница 23: ...y Limited Spring Gardens Whitland Carmarthenshire SA34 0HR Telephone 44 0 1994 240798 Fax 44 0 1994 240061 E mail magstim info magstim com Website www magstim com 7 2 Servicing Enquiries Telephone 44...

Страница 24: ...fficient C10 Coil controller malfunction C11 Rapid coil algorithm constant checksum incorrect C12 Invalid enhanced power byte 1 s compliment comparison test failed C13 Average power checksum incorrect...

Страница 25: ...r had a fainting spell 4 Have you ever had severe i e followed by loss of consciousness head trauma 5 Do you have any hearing problems or ringing in your ears Advise earplugs must be worn as possible...

Страница 26: ...be passed on to any other third party I confirm that I have read and understood the questions above and that my answers are correct and complete to the best of my knowledge and belief PRINT NAME ____...

Страница 27: ...u have metal in the brain skull except titanium e g splinters fragments clips etc If the respondent answers yes or don t know do not administer TMS Have you had surgery in the last 12 months above the...

Страница 28: ...rgical procedure to your spinal cord If the respondent answers yes or don t know do not administer TMS Do you have spinal problems If the respondent answers yes or don t know do not administer TMS Hav...

Страница 29: ...tended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Magstim Rapid2 System can help prevent electromagnetic interference by...

Страница 30: ...dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip...

Страница 31: ...m Field Strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinit...

Страница 32: ...work that supplies buildings used for domestic purposes Harmonic Emissions IEC 61000 3 2 Class B by equipment type Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and Manufactur...

Страница 33: ...imated 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...

Страница 34: ...or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip...

Страница 35: ...tion distance in metres m Field Strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference m...

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