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Thymatron

®

System IV Instructions for Use

6

INTENDED USE

Type of Device:

Device usage:

Application area:

Users:

The Thymatron® System IV is an ECT device

Therapeutic device

For use in treating catatonia, severe major depressive episodes (MDE)
associated with major depressive disorders (MDD) or bipolar disorder (BPD) in
patients age 13 years and older who are treatment-resistant or who require a
rapid response due to the severity of their psychiatric or medical condition.
Alternative available treatments that may or may not be as effective as ECT
include various behavioral and pharmacological interventions.

Psychiatrists

INTENDED PATIENT POPULATION

This device is intended to be used as part of the ECT treatment procedure with patients of age 13 years and
older, under treatment by a medical doctor, a psychologist or a neurologist, with a condition as described in the
Intended Use. Patients must be capable of giving informed consent or have a legally recognized substitute. For
each ECT session, patients should be assessed to be in sufficiently good medical condition to tolerate the
procedure.

ECT does not reliably treat PTSD, other anxiety disorders, personality disorders, or medical disorders that cause
symptoms of major depression, and the Thymatron System IV is not intended for use in treating such disorders.
Anxiety disorders, PTSD, personality disorders, and medical disorders can underlie major depression or coexist
with it, causing suicidality or other depressive symptoms.

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Summary of Contents for Thymatron System IV

Page 1: ...nual Thymatron System IV Somatics LLC 720 Commerce Drive Suite 101 Venice Florida 34292 Technical Support USA and Canada 800 642 6761 or 1 847 234 6761 Fax 847 234 6763 E mail sales thymatron com UM TS4 Rev 21 ...

Page 2: ...e familiar with the FDA final order of December 26 2018 83 FR 66103 66124 Clinicians who administer ECT should participate in continuing education about ECT It is essential that doctors planning to use the Thymatron System IV device read and follow the warnings and recommendations of the Task Force Report of the American Psychiatric Association as set forth in The Practice of Electroconvulsive The...

Page 3: ...11 TECHNIQUE OF ECT 11 TO THE TREATING PHYSICIAN 12 RISK REDUCTION FEATURES 12 RISK OF PROLONGED SEIZURES AND CARDIAC ARRHITMIAS 12 RISK OF THYMATRON COMPONENT FAILURE 13 EFFICACY AND SAFETY OF THE THYMATRON ECT DEVICE 13 EFFICACY OF THE THYMATRON ECT DEVICE 13 SAFETY OF THE THYMATRON ECT DEVICE 15 RISK OF BRAIN INJURY 15 MEMORY AND COGNITIVE RISKS 17 REFERENCES 19 DISCLAIMER WARRANTIES 24 SPECIFI...

Page 4: ... 31 FLEXDIAL OPERATION 31 PAPER LOADING INSTRUCTIONS 34 STIMULUS CABLE CONNECTION 34 MONITORING CABLE CONNECTION 34 LEAD WIRE CONNECTIONS 34 SEIZURE MONITORING CONSIDERATIONS 35 MONITORING ELECTRODES APPLICATION 35 CHANNELS 3 4 SELECTION 36 STIMULUS ELECTRODES APPLICATION 36 IMPEDANCE TEST FOR STATIC IMPEDANCE 37 MOUTH PROTECTION 38 BASELINE EEG COLLECTION 38 STIMULUS DOSE SELECTION 39 STIMULUS PR...

Page 5: ...VE SEIZURE 43 WORSENING OF PSYCHIATRIC SYMPTOMS 43 MANIC SYMPTOMS 44 TREATMENT STIMULUS ADMINISTRATION 44 SEIZURE MONITORING 44 EEG SEIZURE MONITORING 45 AUDIBLE EEG SEIZURE MONITOR 45 EEG PAPER RECORDING 45 ICTAL LINE SEIZURE INDICATOR 45 ENDPOINTS AND INDICES 46 GAIN AND POSITION SETTINGS 47 TURN OFF PRINTING IN A CHANNEL 48 CHANGING EEG GAIN RAPIDLY 48 SEIZURE QUALITY MEASURES 48 BASELINE RETEN...

Page 6: ...IV 52 UPLOAD TREATMENT DATA AUTOMATICALLY TO A PC 53 DISPLAY EEG EMG ECG ON THE PC SCREEN 54 OUTPUT TREATMENT DATA MANUALLY 55 REPRINT THE LAST TREATMENT 57 SET DATE TIME IN PRINTED REPORT 57 ELECTROMAGNETIC COMPATIBILITY EMC 58 GENERAL NOTES 58 LIST OF CABLES AND ACCESSORIES 58 ELECTROMAGNETIC EMISSIONS 59 ELECTROMAGNETIC IMMUNITY 60 INDEX 66 ADDENDUM I FIRMWARE CHANGES 68 ADDENDUM II ELECTRODE P...

Page 7: ...ULATION This device is intended to be used as part of the ECT treatment procedure with patients of age 13 years and older under treatment by a medical doctor a psychologist or a neurologist with a condition as described in the Intended Use Patients must be capable of giving informed consent or have a legally recognized substitute For each ECT session patients should be assessed to be in sufficient...

Page 8: ...tion ECT device use may be associated with disorientation confusion and memory problems When used as intended this device provides short term relief of symptoms The long term safety and effectiveness of ECT treatment has not been demonstrated and long term follow up may be needed Some patients who were suicidal before receiving ECT eventually committed suicide after receiving ECT including after r...

Page 9: ...itoring Cables are not interchangeable and cannot be inserted into the wrong front panel connector Attempting to force the Treatment Cable into the connector intended for the Monitoring Cable and vice versa will damage both the connector and the cable The ECG function of the Thymatron System IV device is used only to obtain a heart rate to help assess the efficacy of the seizure it is not intended...

Page 10: ...vice has no special requirements for restricted environment during transport or storage beyond Standard Sub clause 10 1 criteria EEG EMG and ECG are shown only to assess treatment quality and must not be used for monitoring or diagnosis ADVERSE EVENTS As with any therapy ECT has risks Certain patients will experience adverse events in conjunction with electroconvulsive therapy Patients should be m...

Page 11: ...ath Certain patients are more likely to experience severe adverse events including those with pre existing cardiac illness compromised pulmonary status a history of brain injury or medical complications after earlier courses of anesthesia or ECT Concurrent administration of antipsychotic neuroleptic medication may increase the risks of adverse cardiac pulmonary and neurological events and falls Co...

Page 12: ...school See Addendum V and https www parkinsons va gov resources MOCA Test English pdf Additional tests may be desirable such as for autobiographical memory Studies have shown that the methods used in ECT administration have a significant impact on the nature and magnitude of cognitive deficits In general the American Psychiatric Association recognizes that the following treatment parameters are ea...

Page 13: ...eive in writing and understand the statements listed in Addendum III before receiving ECT You may duplicate and disseminate these Instructions to Patients without limitation Delivery of this required information about ECT should be witnessed and documented in medical records RISK REDUCTION FEATURES RISK OF PROLONGED SEIZURES AND CARDIAC ARRHYTHMIAS The two most frequent complications during an ECT...

Page 14: ...ave since advanced to mitigate those concerns An old study claiming brain injury in cats receiving electrically induced convulsions Alpers and Hughes 1942 failed to use muscle relaxant drugs before stimulation or proper comparison animals Breggin 1979 emphasized cerebral petechial hemorrhages small blood spots on the brain but when animals were restrained from banging their heads no petechiae occu...

Page 15: ...6 and 80 suicided during the study Lin et al 2013 studied 55 treatment resistant depressives who received ECT with a Thymatron System IV Hamilton depression scale scores and Clinical Global Impression Severity scores showed significant reductions after treatment Lin CH et al 2018 compared responses to depression in patients treated with ECT using a Thymatron System IV and patients treated with flu...

Page 16: ...T DEVICE RISK OF BRAIN INJURY Bai T et al 2019 studied 61 depressed patients receving ECT with a Thymatron System IV device compared with 23 healthy controls ECT was found to increase local activity of the dorsomedial prefrontal cortex and enhanced connectivity with the posterior cingulate cortex that was positively correlated with clinical improvement These findings support the functional plastic...

Page 17: ... finding no evidence for ECT induced hippocampal atrophy or cell death Gryglewski G et al 2018 carried out Magnetic Resonance Imaging scans in 14 patients with unipolar treatment resistant depression before and after courses of right unilateral ECT administered with a Thymatron System IV device Increases in volume of the right hippocampus right amygdala and right putamen by were observed localized...

Page 18: ...logical and medical conditions and medications Case reports suggest that some medications e g lithium predispose to cognitive deficits and others e g memantine rivastigmine may decrease them Alizadeh et al 2015 van Schaik et al 2015 Ng et al 2000 used a Thymatron DGx to treat 32 major depressives with courses of right unilateral ECT mean 9 4 The mean percentage recall of Personal Memory test items...

Page 19: ... GE et al 2010 conducted a randomized controlled trial in unipolar major depressives comparing multiple memory test effects after 12 and 24 weeks of ECT with the Thymatron System IV device and pharmacotherapy with a nortriptyline lithium combination Twelve week objective anterograde memory scores and 24 week subjective memory scores were significantly improved for both treatment groups compared wi...

Page 20: ...rapeutic efficacy for depression in bilateral sine and pulse wave electroconvulsive therapy Psychiatry Clin Neurosci 61 168 73 Bai T et al 2019 Functional plasticity of the dorsomedial prefrontal cortex in depression reorganized by electroconvulsive therapy Validation in two independent samples Hum Brain Mapp 40 465 473 Bergfeld IO et al 2018 Treatment resistant depression and suicidality J Affect...

Page 21: ...study Br J Psychiatry 141 367 71 Giltay EJ Kho KH Blansjaar BA 2008 Serum markers of brain cell damage and C reactive protein are unaffected by electroconvulsive therapy World J Biol Psychiat 9 231 235 Gryglewski G et al 2018 Structural changes in amygdala nuclei hippocampal subfields and cortical thickness following electroconvulsive therapy in treatment resistant depression longitudinal analysis...

Page 22: ...uoxetine in alleviating the burden of illness for patients with major depressive disorder a Taiwanese pooled analysis Int J Neuropsychopharmacol 2018 21 63 72 Lisanby SH Maddox JH Prudic J et al 2000 The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 57 581 90 McCall WV Reboussin DM Weiner RD et al 2000 Titrated moderately suprathreshold vs...

Page 23: ...01 312 Ranjkesh F Barekatain M Akuchakian S 2005 Bifrontal versus right unilateral and bitemporal electroconvulsive therapy in major depressive disorder J ECT 21 207 10 Sackeim HA Prudic J Devanand DP et al Effect of stimulus intensity and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy NEJM 1993 328 839 846 Sartorius A et al 2016 Electroconvulsive therapy in...

Page 24: ...ld be the role of rivastigmine A case series Clinics and Practice 5 68 72 Verwijk E 2014 Short and long term neurocognitive functioning after electroconvulsive therapy in depressed elderly a prospective naturalistic study Int Psychogeriatr 26 315 24 Williams MD Rummans T Shampson S et al 2008 Outcome of ECT by race in the CORE multi site study JECT 24 117 21 Winokur G Coryell W Keller M Scheftner ...

Page 25: ...all appropriate information about risks of ECT to patients their families and their guardians if any Somatics LLC warrants that reasonable care has been used in the design and manufacture of this medical device Handling storage and preparation of this medical device as well as other factors relating to the patient diagnosis treatment and other matters beyond the control of Somatics LLC directly af...

Page 26: ... channels channels 1 2 EEG channel 3 EMG channel 4 ECG 8 user selectable gain positions for EEG channels 10 20 50 100 200 500 1 000 and 2000 μV cm and EMG or ECG channels 50 100 200 500 1000 2000 5000 and 10 000 μV cm REQUIREMENTS 100 130 volts 120 volts AC 60 Hz single phase 150 VA 220 240 volt 50 60 Hz switchable STIMULUS GENERATION Waveform bipolar brief pulse square wave IMPEDANCE Static Imped...

Page 27: ...mates by EEG and EMG EEG Frequency Measures 95 Spectral Edge Frequency Median Frequency Relative Delta Power DIMENSIONS Weight 22 lb Height 5 5 Width 17 5 Depth 13 0 The Thymatron System IV Treatment Cable Monitoring Cable and lead wires can be cleaned by wiping them off with a Germicidal Disposable Cloth Steel stimulus electrodes may be cleaned with soapy water or alcohol Thymapad electrodes are ...

Page 28: ... of the protective earth conductor connection F The device has and insulated floating application part REAR PANEL 0344 Declaration of conformity with the provisions of council directive 93 42 EEC concerning medical devices CSA Canadian standard association certified device Waste Electrical and Electronic Equipment Do not throw in standard garbage Recycle or dispose of equipment according to regula...

Page 29: ...trol the 4 channel printer a TREAT button to deliver the treatment stimulus two alphanumeric L E D s the left one with 8 characters the right one with 4 characters and 5 individual dot L E D s to indicate activation of the FlexDial selection mode activation of the Safety Monitor alarm activation of monitoring ECG in channel 4 and whether the preset program or a user set selection is in effect POWE...

Page 30: ...racters plus 5 individual dot L E D s The 8 character L E D is located above the IMPEDANCE TEST button It displays the message SELFTEST immediately after the unit is powered on It displays the message NO BASE following completion of the self test procedure and before baseline EEG collection has been initiated It displays the message TESTING for 1 second when the IMPEDANCE TEST button is pressed It...

Page 31: ... SAFETY MONITOR CIRCUIT ALARM TEST The Thymatron System IV has a Safety Monitor Circuit test button on the back panel labeled ALARM TEST This test can be performed annually or as hospital regulations require The Safety Monitor Circuit test is performed as follows 1 Power on the Thymatron System IV and connect the ECT stimulus cable 2 Rotate the PERCENT ENERGY dial to any setting 3 Connect the ECT ...

Page 32: ...wing general principles 1 Rotating the FlexDial in either direction provides a sequential display of all functions or options in that particular level You can reach any other function or option in the same level by rotating the dial 2 Pressing the FlexDial selects the function or option displayed in the 8 character L E D and advances to the next choice 3 Pressing holding in and rotating the FlexDi...

Page 33: ...the remainder of this manual selection of FlexDial functions and options will be shown by the following shorthand notation with the explanation listed below FLEXDIAL function options Press the FlexDial to display the most recently adjusted FlexDial function Rotate the FlexDial in either direction to display the desired function Press the FlexDial to flash display the option in effect for that func...

Page 34: ...ections CH 3 4 Enables channels 3 4 to monitor either EMG ECG or EEG EEG ENDPOINT Enables endpoint detection of EEG EMG HR measures prolonged seizure alert signal and Baseline Retention BLV INDEXES Enables seizure quality measures EEG FREQ Selects one of three EEG measures PRINTOUT Enables printer and FFT printout sets paper speed UPLOAD Enables sending treatment data to a PC automatically DATA OU...

Page 35: ...cated on the lower left front panel just to the right of symbol of the human figure inside a box The Treatment and Monitoring Cables are not interchangeable They cannot be inserted into the wrong connector However forcing them into the wrong place will damage the connectors or the cables LEAD WIRE CONNECTIONS The Thymatron System IV is shipped with 9 standard length 24 inch lead wires 4 red 4 blac...

Page 36: ... how many channels you choose to monitor Channel 1 must always be used for EEG in order to obtain a baseline EEG sample for the determination of the EEG endpoint and the EEG indexes channel 3 must always be used to monitor EMG channel 4 must always be used to monitor ECG and the green ISO GRND channel must always be used for the ground The preferred 4 channel monitoring configuration using the spl...

Page 37: ...e left side of the head be sure to maintain the same polarity relationship when connecting the corresponding pair of frontal and temporal electrodes on the right side of the head Apply a monitoring electrode to either shoulder as a ground and connect it to the green lead wire clip CHANNELS 3 4 SELECTION EEG is always monitored from channels 1 2 and they are not user selectable Channels 3 4 can mon...

Page 38: ...over the patient s right temple as above Remove a Thymapad from its wrapper peel it from its plastic backing and apply it firmly to the bare skin at the right temple Part the hair on the right side of the head near the vertex and moisten the scalp thoroughly with a saline soaked gauze pad or saline solution spray Patients with dense wiry hair may require full saline saturation of the hair and scal...

Page 39: ... the skin under the stimulus electrodes with a fine emery board or Skin Prep tape 3 M to remove the top layer of dead cells and sebum Reapply the stimulus electrodes exactly as before A common reason for high impedance is that one or more steps were omitted from skin site preparation Please be sure to follow each instruction step when using Thymapad stimulus electrodes During cold weather skin thi...

Page 40: ...ained However the treatment itself will not be affected It is not necessary for the Thymapad stimulus electrodes to be applied in order to obtain a baseline EEG collection Do not be concerned with an impedance reading 3000 ohms when no stimulus electrodes have been applied baseline EEG collection will proceed anyway Static impedance will be tested after the stimulus electrodes have been applied Re...

Page 41: ...US PROGRAMS FACTORY PROGRAMMED There are 5 factory set stimulus programs The LOW programs automatically adjust the frequency to provide the longest stimulus duration available for a given PERCENT ENERGY setting providing the optimum stimulus for each dose The LOW 0 5 program is the only preset program that will show as PRESET on the front panel L E D All of these factory set programs can go to 100...

Page 42: ...li of up to 100 ENERGY can be delivered because for this program only the frequency can go as high as 140 Hz STIMULUS DOSE FOR BILATERAL BITEMPORAL BIFRONTAL LART ECT For the initial treatment select the LOW 0 5 program The PERCENT ENERGY dial should be set to approximately one half the patient s age e g 25 for a 50 year old If no seizure activity results the PERCENT ENERGY setting should be incre...

Page 43: ...dministered at doses approximately 2 times this threshold e g 40 ENERGY for a patient with 20 ENERGY seizure threshold BENCHMARK METHOD FOR SETTING AND ADJUSTING STIMULUS Because neither seizure duration nor seizure threshold are systematically related to the clinical efficacy of an ECT treatment you may wish to consider regulating the stimulus dose according to a physiological measurement that ha...

Page 44: ...t is typically immediate and vigorous such as full anesthesia with propofol These patients should be considered for transfer to the ICU because of high risk for sudden cardiopulmonary arrest a risk that lasts several days A different presentation of tardive seizure is onset of seizure at an ECT session in response to anesthesia alone without an electrical stimulus This can be managed in the same w...

Page 45: ... the impedance is 3000 the warning tone is extended to 3 seconds If the TREAT button is still pressed the treatment will be delivered 2 The TREAT button lights up and an intermittent buzzing tone sounds while the current is being delivered 3 The TREAT button light and buzzing tone both turn off when the treatment stimulus ends The TREAT button can then be released 4 The Audible EEG seizure monitor...

Page 46: ...on of the Audible EEG seizure monitor EEG PAPER RECORDING 1 Paper EEG recording prior to the treatment stimulus can be initiated after the EEG electrodes have been properly applied by pressing the START STOP button on the front panel This will provide a paper record of the patient s baseline recording The printer stops during treatment stimulus administration 2 Automatic paper EEG recording begins...

Page 47: ... the end of treatment report will state the message Baseline not available In about 10 20 of ECT treatments the EEG endpoint is not readily determined Abrams 1997 This typically occurs when paroxysmal activity decreases too gradually to provide a clear visual endpoint or when the immediate post seizure EEG contains high amplitude activity In these circumstances inability to detect a precise EEG en...

Page 48: ...e recording paper depends on the amplitude or gain of the signal Thus it is always necessary to set the GAIN in a specific channel before setting the POSITION Enter the FlexDial function and rotate to Channel n where n is 1 2 3 or 4 Press the FlexDial to display the current gain setting for channel n Setting the gain for channel number n to off turns off printing of that channel You can adjust the...

Page 49: ... the INDEXES function level that can be individually enabled disabled EEG monitoring must be enabled to obtain these measures Their names and FlexDial designations are as follows Average Seizure Energy Index ASEI ON OFF Postictal Suppression Index PSI ON OFF Maximum Sustained Power and MSP ON OFF Time to Peak Power Maximum Sustained Coherence and COH ON OFF Time to Peak Coherence Duke University A...

Page 50: ...timulation without acquiring a new EEG baseline TO ENABLE DISABLE SEIZURE QUALITY MEASURES FLEXDIAL INDEXES AESI ON OFF PSI ON OFF MSP ON OFF COH ON OFF DUKE ON OFF In the INDEXES function level repeatedly pressing the FlexDial will show a sequential flashing status display ON OFF for ASEI PSI MSP COH and DUKE measures in that order Rotating the FlexDial will flash display the enable disable ON OF...

Page 51: ...an algorithm for extracting frequency information from the EEG signal to perform a Power Spectral Analysis that displays the EEG frequencies in various bandwidths for advanced clinical or research purposes The Thymatron System IV is shipped with the FFT printout disabled to enable this feature FLEXDIAL PRINTOUT FFT ON FFT OFF USER SPECIFIED FLEXDIAL SELECTIONS This feature allows the user to save ...

Page 52: ... SETTING RESET SETTING including channel Gain G and Position P Chann 1 G1 200 μV P1 AUTO Chann 2 G2 200 μV P2 AUTO Chann 3 G3 1000 μV P3 AUTO Chann 4 G4 1000 μV P4 AUTO FREQUENC Variable with LOW 0 5 program P WIDTH 0 5mS PROGRAMS LOW 0 5 program CH 3 4 EMG ECG ENDPOINT EEG ON EMG ON HR ON PHR ON ESA OFF BLV 2 INDEXES ASEI ON PSI ON MSP ON COH ON DUKE OFF EEG FREQ FREQ OFF PRINTOUT PRINT 25 FFT OF...

Page 53: ...t NOTE All procedures listed below require the GENIE IV software tool to be installed on a PC connected to the Thymatron System IV through the rear panel RS 232 serial port and the GENIE IV software program opened to the proper section Please consult the GENIE IV manual for further details INPUT HOSPITAL NAME FOR THE PRINTED REPORT This name will replace the Thymatron System IV S N line on the sta...

Page 54: ...xDial mode This treatment data will now replace that of the last treatment given and will stay in the Thymatron System IV memory until the unit is turned off or another treatment is given To reprint this treatment on a paper record see the DATA OUT section below UPLOAD TREATMENT DATA AUTOMATICALLY TO A PC This feature allows for the automatic transfer of the treatment data to a PC after the printe...

Page 55: ...f all enabled EEG EMG ECG channels via the PC screen providing a constantly updated display of the actual EEG EMG ECG tracings before and after the treatment stimulus has been administered This display will not affect the printed paper recording Before starting to display make sure all the connections are correct and the GENIE IV software tool is opened From the GENIE IV main menu click on WINDOW ...

Page 56: ...he FFT points and end of treatment report FFT DATA Sends the FFT points and end of treatment report RESULTS Sends ASCII files of end of treatment report RETURN Returns to the DATA OUT function level of the FlexDial FLEXDIAL DATA OUT REPRINT RAW DATA FFT DATA RESULTS RETURN 1 Press the FlexDial to display the most recently adjusted FlexDial function 2 Rotate the FlexDial until DATA OUT is displayed...

Page 57: ...Thymatron System IV Instructions for Use 56 ...

Page 58: ...ment just printed before the re start will be deleted from memory Also if the unit is turned off another treatment is transferred from the computer or another treatment is given the earlier treatment data will be lost The procedure for reprinting the treatment data is FLEXDIAL DATA OUT REPRINT While the treatment data is being reprinted the REPRINT message will flash until all the data has been re...

Page 59: ...evice s producing these pulses and maintain sufficient distance between the Thymatron System IV and the device s to prevent reoccurrence if this is not possible shielding may be required 5 This medical electrical equipment needs special precautions regarding Electromagnetic Compatibility EMC and needs to be installed and put into service according to the EMC information provided in this chapter 6 ...

Page 60: ...ore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Thymatron Systems are suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for Domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctua...

Page 61: ...rinted waveforms These can be differentiated from physiological waveforms To minimize these effects mains power quality should be that of a typical commercial or hospital environment Surge 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 a...

Page 62: ... used no closer to any part of the Thymatron System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 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 meters m Field stre...

Page 63: ...Thymatron System IV Instructions for Use 62 absorption and reflection from structures objects and people ...

Page 64: ...field strengths should be less than V1 V m Recommended separation distances between portable and mobile RF communications equipment and the Thymatron System Thymatron ECT Systems are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Thymatron System can help prevent electromagnetic interference by maintaining a mini...

Page 65: ...er rating of the transmitter in Watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800MHz 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 Note 3 Stated separation distances will assure safe operation of th...

Page 66: ...ovisions of the EC Directive which apply to them This declaration is based on the application of the Quality System approved for the manufacture and final inspection of the products concerned in accordance with Annex II of the EC Directive The conformity of the production quality assurance set out in Annex II This declaration is supported by the Quality System certification based on the harmonized...

Page 67: ...ONITORING 45 ELECTROMAGNETIC COMPATIBILITY EMC 57 EMG Motor Seizure Endpoint Determination 46 EMG endpoint seizure duration 46 ENABLE DISABLE SEIZURE QUALITY MEASURES 49 Enter FLEXDIAL Mode 31 Exit FLEXDIAL Mode 32 EXPLANATION OF SIGNS AND SYMBOLS 27 F FFT 50 FLEXDIAL function options 32 FLEXDIAL Functions and What They Control 33 FLEXDIAL Mode Procedure 32 FLEXDIAL OPERATION 31 FREQUENCY SELECTIO...

Page 68: ...s 11 17 SIGNS AND SYMBOLS 27 SPECIFICATIONS 25 Spectral Edge Frequency 26 49 stimulus cable 34 STIMULUS CABLE CONNECTION 34 STIMULUS DOSE FOR BILATERAL 41 STIMULUS DOSE FOR UNILATERAL 41 STIMULUS DOSE SELECTION 39 STIMULUS ELECTRODES APPLICATION 36 STIMULUS OUTPUT 25 STIMULUS PROGRAM SELECTION 40 STIMULUS TITRATION 42 STIMULUS TITRATION PROCEDURE 42 T The AVERAGE SEIZURE ENERGY INDEX ASEI 48 TRANS...

Page 69: ...nnection 5 10 5 1 01 Added Diagnostic messages for EEG endpoint 5 0 5 20 8 1 01 Added LOW 0 25 program 5 0 5 30 5 1 02 Added Automatic upload to PC 6 3 SEI upgraded to ASEI SGI retired Impedance test increased to 800 Hz 5 40 11 15 02 Added EEG Frequency Measures 6 3 5 41 2 1 03 Eliminates need for recalibration 6 3 after chip upgrade 5 50 7 1 04 Improved algorithm for PSI 6 3 Change program via Pe...

Page 70: ...to 70 Hz 6 3 5 62 09 07 10 Reset USER mode to last frequency 6 3 5 63 11 03 10 Changed Baseline Validity settings 6 3 5 71 03 22 16 Added Driver code for rev B printer 2X DGx 6 8 5 72 01 10 18 Enabled Restart printer automatically 6 81b 5 80 11 12 18 Added 1 increments standard 6 81b ...

Page 71: ...r Use 70 ADDENDUM II ELECTRODE PLACEMENT 4 channel setup with Splitter 2 EEG 1EMG 1 ECG channel Electrode connections for channel 1 2 EEG channel 3 EMG channel 4 ECG recording to Thymatron System IV ECT to Thymatron System IV EEG ECG EMG ...

Page 72: ...Thymatron System IV Instructions for Use 71 Electrode Splitter C C C C C h 1 1 2 1 3 1 4 1ls 0 o 0 0 0 0 G nd to Thymatron System IV EEG ECG EMG ...

Page 73: ...tem IV Instructions for Use 72 4 channel setup 2 EEG 1 EMG 1 ECG channel Electrode connections for channel 1 2 EEG channel 3 EMG channel 4 ECG recording to Thymatron System IV ECT to Thymatron System IV EEG ECG EMG ...

Page 74: ...stem IV Instructions for Use 73 3 channel setup 1 EEG 1 EMG 1 ECG channel Electrode connections for channel 1 EEG channel 3 EMG channel 4 ECG recording to Thymatron System IV ECT to Thymatron System IV EEG ECG EMG ...

Page 75: ...matron System IV Instructions for Use 74 2 channel setup 1 EEG 1EMG channel Electrode connections for channel 1 EEG channel 3 EMG recording to Thymatron System IV ECT 0 0 to Thymatron System IV EEG ECG EMG ...

Page 76: ...Thymatron System IV Instructions for Use 75 1 channel setup 1 EEG channel Electrode connections for channel 1 EEG recording to Thymatron System IV ECT to Thymatron System IV EEG ECG EMG ...

Page 77: ...ough the incidence of permanent cognitive memory loss was not supported by the clinical literature some patients have reported a permanent loss of memories of personal life events i e autobiographical memory Patients treated with ECT may experience manic symptoms including euphoria and or irritability impulsivity racing thoughts distractibility grandiosity increased activity talkativeness and decr...

Page 78: ...atment A single study found impairment in spatial recognition memory continuing one month after ECT Typical course of treatment The Thymatron System IV works while the patient is unconscious from anesthesia by delivering a brief controlled dose of electric current to the scalp in order to induce a brain seizure This seizure changes chemicals in the brain called neurotransmitters which are understo...

Page 79: ...Thymatron System IV Instructions for Use 78 ADDENDUM IV FLEXDIAL FLOW CHART ...

Page 80: ...Thymatron System IV Instructions for Use 79 ADDENDUM V MOCA TEST ...

Page 81: ...g on the size of the patient s head Position the first electrode about one inch above the mid point of an imaginary straight line between the external auditory meatus and the outer canthus of the eye This is usually on the flat part of the temple Then while holding the first electrode in place wrap the perforated strap across the forehead and position the second electrode over the same spot on the...

Page 82: ...e treatment cable plugged into the electrode receptacles The impedance TEST button is then pressed If the result is above 3000 ohms one or both electrodes are not properly connected to the cable or to the head Perhaps the electrodes moved from the intended position the cable is dislodged or broken or more conductive gel is needed ...

Page 83: ...45 1 50 1 56 1 61 1 67 1 95 2 23 2 51 2 79 2 19 2 39 2 59 2 79 2 99 3 19 3 39 3 59 3 79 3 99 LOWEST CHARGE RATE program 0 25 standard pulsewidth set Energy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Frequency hz 10 10 10 10 10 20 20 20 20 20 30 30 30 30 30 30 30 30 30 30 40 40 Pulse width ms 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 2...

Page 84: ...92 1904 2016 2128 2240 Duration sec 6 43 6 71 6 99 5 81 6 04 6 26 6 49 6 71 7 83 7 46 7 19 7 99 7 69 7 46 7 28 7 84 7 63 7 46 7 93 7 75 7 60 8 00 LOW 0 50 CHARGE RATE program Energy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Frequency hz 10 10 10 10 10 10 10 10 10 10 20 20 20 20 20 20 20 20 20 20 20 20 Pulse width ms 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5...

Page 85: ... 1 0 1 0 1 0 1 0 1 0 1 0 Pulse number 129 134 140 146 151 157 162 168 196 224 252 280 308 336 364 392 420 448 476 504 532 560 Duration sec 4 23 4 42 4 62 2 85 3 00 3 06 3 21 3 27 3 85 4 43 5 01 5 49 4 29 4 69 5 09 5 49 5 89 6 29 6 69 7 09 7 49 7 89 Charge and Energy at the Energy Settings of Stimulus Dose Dial Energy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Charge mC 5 10 1 15 1 20...

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