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Chapter 11  -  Intended use and therapeutic application

74

Patient population

age group:

18 - 99 years

weight:

45 - 120 kg

nationality:

global

patient state:

conscious adult patients 

disabilities:

not relevant

excluded patient types:

patients with opened skull, after trepanation or with heart resp.
brain pacemaker
patients with any skin damage

further criteria:

none

Intended user profile

The responsiblity to inform about the current state of research and clinical
application and to further their education rests with the operators.

2. physicians / psychologists

education:

university degree

knowledge:

effects of non-invasive brain stimulation on the brain

language knowledge:

german and / or english

Содержание DC-Stimulator

Страница 1: ...Programmable Direct Current Stimulator DC STIMULATOR User manual...

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Страница 5: ...IMULATOR 20 Equipment 20 Consumables 22 Type label 23 Power supply 25 Activating the DC STIMULATOR 25 Mode standby 25 Turning off the DC STIMULATOR 27 Operating Basics 4 28 External charger 29 Electro...

Страница 6: ...patibility 8 58 Information for ensuring electromagnetic compatibility 59 Guidance and manufacturer s declaration electromagnetic emissions 59 Guidance and manufacturer s declaration electromagnetic i...

Страница 7: ...7 Table of contents 82 Electrode paste Ten20...

Страница 8: ...hrenia possible Users of the DC STIMULATOR are physicians and psychologists with knowledge about the effects of non invasive brain stimulation and experience in brain stimulation The essential perform...

Страница 9: ...information to your attention This informs the user that failure to follow these instructions may cause harm to the user and others or may damage the DC STIMULATOR or other equipment This is a genera...

Страница 10: ...normative document s are fulfilled EN 60601 1 2006 Medical electrical equipment Part 1 General requirements for safety EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for...

Страница 11: ...be opened The manufacturer assumes no responsibility for any damage caused by such a practice If any technical problems are experienced always inform the dealer or manufacturer Medical electrical devi...

Страница 12: ...For safety reasons never use bipolar stimulation on any other part of the body apart from the head Bipolar stimulation setups can harm the heart should the electrodes be misplaced The manufacturer acc...

Страница 13: ...d or run close to flammable mixtures of anesthetic gas because it has no appropriate protection The DC STIMULATOR must not be positioned or run in an oxygen rich environment because it has no protecti...

Страница 14: ...ou attach the electrodes with electrode paste only use the electrode paste supplied by the manufacturer The use of other electrode pastes and gels might result in in redness of the skin erythema and s...

Страница 15: ...ent The safe stop mode can prevent this by reducing the current slowly and continuously 1 mA per second down to 0 A The safe stop mode is active in any stimulation mode and works during either manual...

Страница 16: ...to drastic temperature fluctuation e g during transport the resulting condensation might damage the device For safety reasons wait until the DC STIMULATOR has reached room temperature at least 1 hour...

Страница 17: ...Chapter 3 Getting Started 17 DC STIMULATOR DC STIMULATOR upside Figure 1 Upside of DC STIMULATOR DC STIMULATOR bottom side Figure 2 Bottom side of the DC STIMULATOR...

Страница 18: ...y to note the manual s instructions for this socket applied part BF refer to instruction manual ISO 7010 M0002 A moveable front plate B socket for charger C 1 socket 1 anode positive for touch proofed...

Страница 19: ...ors 2 mm to connect the adapter box TRIGGER IN F 4 socket 4 signal for touch proofed safety connectors 2 mm to connect the adapter box TRIGGER IN DC STIMULATOR rear side Figure 4 Rear side of the DC S...

Страница 20: ...1 adapter box 2 BNC socket 3 touch protected connecting cable 2 mm to plug in into socket 4 signal of the DC STIMULATOR 4 touch protected connecting cable 2 mm to plug in into socket 3 ground of the D...

Страница 21: ...des 1 pair 2 sponge pads for the rubber electrodes 1 pair red blue 3 rubber strap combination for fixing the rubber electrodes on the head 1 set 4 connection cables approx 150 cm 1 pair red blue Only...

Страница 22: ...s shown in Figure 7 Figure 7 Type label of the DC STIMULATOR manufacturer address and production year serial number applied part BF Mind the manual Attention certified by the European Union Notified B...

Страница 23: ...24 months MTK 12 months and added by a hole using a ticket punch Power supply The DC STIMULATOR is equipped with built in rechargeable and non spillable batteries This type of battery has several adv...

Страница 24: ...ntrolled charger Mascot 2116 for charging the DC STIMULATOR It is optimized for the used type of battery and continuously monitors battery state to prevent overcharging or overdischarging Use of other...

Страница 25: ...f time it switches automatically to standby mode in order to save energy After 30 seconds of inactivity the display turns dark Additionally an acoustic warning signal beep reminds you every 60 seconds...

Страница 26: ...Chapter 3 Getting Started 26 Figure 9 Turning off the DC STIMULATOR...

Страница 27: ...e electrodes and charger at the same time Take care of the operative front plate to avoid such a circumstance Never remove the front plate The manufacturer accepts no responsibility for injury caused...

Страница 28: ...he DC STIMULATOR is deactivated automatically following insertion of the charger s plug until it is removed again Figure 14 Charger connector and socket of the DC STIMULATOR Figure 15 Connected charge...

Страница 29: ...e manufacturer accepts no responsibility for any injury caused by such use Electrodes During a stimulation procedure the electrodes are connected to socket 1 anode positive and socket 2 cathode negati...

Страница 30: ...the rubber electrode can be damaged The manufacturer assumes no liability for damages in this case Always use a damp sponge when insert the electrode Never use tap water to wet the sponges or the ski...

Страница 31: ...n physiologic salt solution ca 5 minutes before the new measurement Impedance control Before beginning stimulation the DC STIMULATOR will detect the impedance levels A DC current of 120 A is used for...

Страница 32: ...V which is above the limit Impedance control is designed for measurements with real electrodes A comparison with ohmic resistances could lead to divergent values especially in all noise modes and wit...

Страница 33: ...additional components described below For more details please ask your dealer or the manufacturer Trigger input To start stimulation remotely or via other devices the DC STIMULATOR can be used with an...

Страница 34: ...ner should be used Spray some cleaner on a soft and clean cloth before wiping the display gently Never spray cleaner directly onto your DC STIMULATOR and never let liquid run into the device Never use...

Страница 35: ...nd the air humidity should be between 20 to 93 non condensing The air pressure must be between 690 to 1080 hPa 3000 m If the device has been exposed to low temperatures or to drastic temperature fluct...

Страница 36: ...ke sure that the optical fiber cable of the AMPLIFIER never gets folded Additionally used pictogram s and warning signs to the packaging This side up Fragile Handle with care Keep dry Room temperature...

Страница 37: ...is not used for a while it is recommended that it is stored in a safe dry and dust free place The temperature must be between 10 and 40 C 50 and 104 F and the air humidity must be between 20 and 93 no...

Страница 38: ...the device Display button menu The DC STIMULATOR is operated by using the 4 buttons near the display s corner see Figure 19 In the whole Software Reference Manual the numbering of the buttons shown in...

Страница 39: ...e DC STIMULATOR is used further see Manual External charger for details A blank loudspeaker symbol indicates that the signal tone of the DC STIMULATOR for warnings and notices is not active After acti...

Страница 40: ...s To modify the parameters current duration etc please follow these instructions After you have switched to the desired stimulation waveform mode move the cursor to line 3 by pressing button 3 Press b...

Страница 41: ...f the stimulation current is below 150 A the impedance check does not work correctly because of technical reasons A long fade in value leads to a current below 150 A for several seconds and most time...

Страница 42: ...tion If the impedance is below the preset impedance limit see Software Reference Manual Impedance limit the stimulation starts In case impedance exceeds the predefined limit e g due to insufficient el...

Страница 43: ...y measures the electrode impedance during stimulation If the predefined impedance limit is exceeded during stimulation an error warning occurs and the stimulation will pause immediately Press button 1...

Страница 44: ...imulation will be performed after the trigger event repetitive Trigger input is enabled for repetitive triggering After pressing Y in STIMULATION menu see Software Reference Manual STIMULATION the DC...

Страница 45: ...of the impedance limit please follow these instructions Figure 26 Press button 2 or 4 to select main menu SYSTEM Move the cursor to line 2 on the display by pressing button 3 Switch to submenu impeda...

Страница 46: ...ing by pressing button 2 or 4 several times Move the cursor to line 4 on the display by pressing button 3 Select the setting A B C D by pressing button 2 or 4 If you now use button 1 to move the curso...

Страница 47: ...d pseudo stimulation must be prepared The code list can be executed by staff Only the supervisor has information on which code belongs to normal or pseudo stimulation We recommend to keep a record eac...

Страница 48: ...26972 Sham stimulation means that the chosen stimulation mode will be displayed but that no stimulation will occur Only a small current pulse will occur every 550 ms 110 A over 15 ms instead of the st...

Страница 49: ...normal like stimulation in order to give the patient the same kind of skin sensations that he feels with a normal stimulation After that initial sequence only continuous impedance control is performed...

Страница 50: ...correctly Procedure of a study After rebooting the system in active study mode the display indicates only the limited selection of the settings Figure 30 Figure 30 Display in active study mode limite...

Страница 51: ...e standard operation mode will not work correctly Language set You can operate the DC STIMULATOR in German or English language The language can be adjusted in this submenu To change the language setti...

Страница 52: ...led To change the settings of the signal tone please follow these instructions Press button 2 or 4 to select main menu SYSTEM Move the cursor to line 2 on the display by pressing button 3 Switch to su...

Страница 53: ...rightness NB Backlight brightness is an important factor of the DC STIMULATOR operating time since backlight needs at maximum 30 of the power consumption MASTERCODE optional The MASTERCODE is only ava...

Страница 54: ...button 1 to increase the value by 1 per press After 9 comes 0 Now press button 3 to move the cursor to the next digit Select the corresponding number by pressing button 1 several times Repeat until al...

Страница 55: ...ubleshooting 6 If any further assistance is required or if any problems are experienced during DC STIMULATOR use please contact your dealer or the manufacturer Hotline Tel 49 0 3677 68 979 0 Fax 49 0...

Страница 56: ...on backlight brightness and applied current power supply via built in rechargeable and non spillable batteries external battery charger Mascot 2116 touch protected connecting electrode sockets 1 5 mm...

Страница 57: ...an operating time of 5 min at the time of delivery This offset can increase up to 20 A during normal operation It is recommended to request a check of this offset during normal safety inspection Trig...

Страница 58: ...uch as mobile phones may influence medical electrical devices It is imperative that you observe the safety distances given below Protect the contacts of all sockets and plugs of the device or system a...

Страница 59: ...EC 61000 3 2 not applicable The device or system is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network...

Страница 60: ...of battery during therapy Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 95 reduction for 1 cycle 30 reduction for 25 cycles 60 reduction for 5 cycl...

Страница 61: ...d d is the recommended separation distance in metres m a Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each fre...

Страница 62: ...s designed during exposure and do not return to normal operation until exposure is removed and the device system is reset by simple operator use action This means for the user of the neuroConn system...

Страница 63: ...applicable 11 7 23 4 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequenc...

Страница 64: ...al products law a technical safety inspection has to be done every 24 month only in Germany Please read also the service manual and or the Medizinproduktebuch Germany Inspections or maintenance activi...

Страница 65: ...check of the different operation modes simulation of electrodes slipping off of by changing the resistance 3 metrological test measuring the output current of the DC STIMULATOR check whether the accu...

Страница 66: ...ein Str 3 98693 Ilmenau Germany Tel 49 03677 68979 0 Fax 49 03677 68979 15 E Mail info neuroconn de Web www neuroconn de International Rogue Resolutions Sophia House 28 Cathedral Road Cardiff CF11 9LJ...

Страница 67: ...920 660198 E Mail info symbioticdevices com au Web www symbioticdevices com au Benelux Belgium The Netherlands Luxembourg MedCaT B V Doorndistel 1 NL 7891 WV KLAZIENAVEEN The Netherlands Tel 31 591 30...

Страница 68: ...esearch com China Rogue Resolutions Sophia House 28 Cathedral Road Cardiff CF11 9LJ Great Britain Tel 44 2920 660198 E Mail info rogue resolutions com Web www rogue resolutions com Egypt BIOMEDICA Eng...

Страница 69: ...gro com Web www largro com India Sigma Technolgies 55 Periyar Nagar Uppilaipalaym Post Varadharajapuram 641015 Coimbatore India Tel 91 952718737 E Mail info sigmatech co in Web www sigmatech co in Ind...

Страница 70: ...apan Tel 81 3 3818 8631 Fax 81 3 3818 6832 E Mail miyuki miyuki net co jp Web www miyuki net co jp Korea HOSPI Co Ltd 601 D S Tower 312 Jungdae ro Songpa gu Seoul 134 830 Korea Tel 82 02 441 7712 Fax...

Страница 71: ...12 E Mail ruben sanz almevan com Web www almevan com Taiwan R O C Trushine Medical Instruments Co Ltd 1F No 4 Lane 19 Fu He Road Yung Ho District New Taipei City 234 Taiwan Tel 886 2 8921 3028 Fax 886...

Страница 72: ...Web www binasmedikal com Medelek Elektronic ve Bilgisayar Cihazlari San ve Tic Ltd Sti Dar l Aceze Cad No 47 Famas Is Merk Kat 1 34384 Istanbul Turkey Tel 90 212 320 56 90 Fax 90 212 320 56 94 E Mail...

Страница 73: ...mulation Oxford Library of Psychology 2008 The transcranial direct current stimulation tDCS as a part of the non invasive Interventional Neurophysiology applies weak electrical currents up to 2 mA at...

Страница 74: ...skull after trepanation or with heart resp brain pacemaker patients with any skin damage further criteria none Intended user profile The responsiblity to inform about the current state of research an...

Страница 75: ...n neuropathic pain in the lower limbs problems with speech and motor skills after stroke auditory hallucinations in schizophrenia Contraindications Under the following conditions a transcranial electr...

Страница 76: ...left hemisphere or contralateral to pain side tDCS anodal duration 20 minutes current 1 2 mA electrode size 5x7 cm treatment schedule 5 20 daily sessions Level B Motor stroke possible effect of combin...

Страница 77: ...t temporo parietal junction or the right DLPFC tDCS anodal duration 20 minutes current 2 mA electrode size 5x7 cm treatment schedule 10 daily sessions Level C Level A definitive efficacy Level B proba...

Страница 78: ...athodal tDCS of epileptic focus Disorders of consciousness No recommendation for anodal tDCS of the DLPFC Alzheimer s disease No recommendation for anodal tDCS of the temporo parietal cortex or the le...

Страница 79: ...any time according to the latest research and development in science and technology The DC STIMULATOR and manual are subject to change without notice The manufacturer accepts no responsibility for da...

Страница 80: ...Chapter 13 Notes 80 Notes 13...

Страница 81: ...s of some equipment and consumables of the DC STIMULATOR These manuals refer to the DC STIMULATOR equipped with all options and consumables Depending on the specification of your DC STIMULATOR some of...

Страница 82: ...Chapter 14 Manuals Equipment 82 Electrode paste Ten20...

Страница 83: ...ufacturer s declaration electromagnetic immunity 59 separation distances 62 essential performance 73 F FAT 65 final acceptance test 65 H handling 38 I impedance check 41 impedance control 31 41 manual...

Страница 84: ...S 40 storing 37 study course 49 study mode 47 disabling 49 enabling 49 preparation 49 SYSTEM submenu backlight brightness 52 submenu impedance limit 45 submenu language set 51 submenu load setting 46...

Страница 85: ...Publisher neuroConn GmbH Albert Einstein Str 3 98693 Ilmenau Fon 49 36 77 68 979 0 Fax 49 36 77 68 979 15 E Mail info neuroconn de Internet www neuroconn de...

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