Somatics Thymatron System IV User Manual
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Somatics Thymatron System IV User Manual

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User Manual
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

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  • Page 1 User Manual 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 It is essential to read all of the information in the Safety Information section of this manual, pages 7 - 9. Copyright© 1999; 2000; 2001; 2002; 2003; 2004; 2005; 2006; 2009; 2013; 2015; 2016; 2018; 2019 Somatics LLC. All rights reserved. No portion of this manual may be reproduced by any means without the permission of Somatics LLC.

  • Page 3: Table Of Contents

    Thymatron System IV Instructions for Use ® TABLE OF CONTENTS INTENDED USE ..............................6 INTENDED PATIENT POPULATION ........................6 SAFETY INFORMATION ............................7 WARNINGS..............................7 PRECAUTIONS.............................. 7 ADVERSE EVENTS ............................... 9 SERIOUS ADVERSE EVENTS ........................10 OTHER RISKS ............................. 10 RISKS OF COGNITIVE MEMORY EFFECTS ..................
  • Page 4 Thymatron System IV Instructions for Use ® FRONT PANEL ............................27 REAR PANEL............................... 27 INSTALLATION ..............................28 OPERATING INSTRUCTIONS ..........................28 POWER ON/OFF ............................28 SELF TEST ..............................28 PERCENT ENERGY DIAL .......................... 29 LIGHT-EMITTING FUNCTION DISPLAYS ..................... 29 SAFETY MONITOR CIRCUIT ALARM TEST ..................30 FRONT PANEL JACKS ..........................
  • Page 5 Thymatron System IV Instructions for Use ® FREQUENCY SELECTION ........................41 PULSEWIDTH SELECTION ........................41 STIMULUS DOSE FOR BILATERAL, BITEMPORAL, BIFRONTAL, LART ECT ....... 41 STIMULUS DOSE FOR UNILATERAL ECT .................... 41 STIMULUS TITRATION PROCEDURE ....................42 “BENCHMARK” METHOD FOR SETTING AND ADJUSTING STIMULUS ........42 TYPICAL COURSE OF TREATMENT .......................
  • Page 6 Thymatron System IV Instructions for Use ® TURN OFF PRINTING ENTIRELY ....................50 POWER SPECTRAL ANALYSIS (FFT) SELECTION ................50 USER SPECIFIED FLEXDIAL™ SELECTIONS ..................50 RESET FLEXDIAL™ SETTINGS TO FACTORY VALUES ............51 TRANSFERRING DATA BETWEEN A PC AND THYMATRON® SYSTEM IV ........52 INPUT HOSPITAL NAME FOR THE PRINTED REPORT .............

  • Page 7: Intended Use

    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...

  • Page 8: Safety Information

    Thymatron System IV Instructions for Use ® SAFETY INFORMATION Please read the following important safety requirements before using the Thymatron® System IV ECT Instrument. WARNINGS Various medical conditions are associated with substantially increased risk from ECT, including risk of death. These include unstable or severe cardiovascular conditions (recent myocardial infarction, unstable angina, poorly-compensated congestive heart failure, severe valvular cardiac WARNING disease), vascular aneurysms susceptible to rupture with increased blood pressure, increased...
  • Page 9 CAUTION spilled on it. Power the unit off and have it checked by a qualified technician before powering it on or using it again. Only use the Thymatron® System IV device with the Somatics’ Treatment and Monitoring Cables. CAUTION The Treatment and Monitoring Cables are not interchangeable and cannot be inserted into the wrong front panel connector.

  • Page 10: Adverse Events

    Thymatron System IV Instructions for Use ® Do not dispose of your Thymatron® System IV device in the general waste. As per Directive 2002/96/EC for the disposal of electrical and electronic equipment, please contact the CAUTION manufacturer for instructions. Prior to initiating ECT on a patient with a cochlear implant, healthcare professionals should discuss the issue with an otolaryngologist or audiologist and review the cochlear implant Instructions for Use.

  • Page 11: Serious Adverse Events

    Thymatron System IV Instructions for Use ® SERIOUS ADVERSE EVENTS Recent estimates in the medical literature of the mortality rate associated with ECT are 1 per 10,000 patients or 1 per 80,000 treatments. Other serious adverse events have occurred, including adverse reaction to anesthetic agents / neuromuscular blocking agents;...

  • Page 12: Risks Of Cognitive Memory Effects

    Thymatron System IV Instructions for Use ® RISKS OF COGNITIVE MEMORY EFFECTS Cognitive side effects are experienced in varying types and severity by ECT patients. ECT treatment may be associated with disorientation, confusion and memory problems, including short-term (anterograde) and long- term (retrograde or autobiographical) memory loss following treatment.

  • Page 13: To The Treating Physician

    In addition to the paper EEG record, the Somatics Thymatron® device has an auditory EEG monitor that allows the user to tell without looking at the paper EEG whether or not EEG signs of seizure have stopped. In a study of 82 consecutive ECTs using this auditory EEG, physicians determined the occurrence and the duration of the induced EEG seizure with a high degree of accuracy (Swartz and Abrams, 1986).

  • Page 14: Risk Of Thymatron® Component Failure

    ECT, moderate-dose right unilateral ECT, or low-dose bifrontal ECT. Blindly-obtained The DG, DGx and Thymatron System IV deliver the same electricity. The Thymatron IV differs from previous models in monitoring and in ways that the doctor can select the electrical stimulus. Somatics no longer sells the DG or DGx...
  • Page 15 Thymatron System IV Instructions for Use ® Hamilton Depression scale scores at baseline and after the ECT course showed an overall 66% improvement, with the highest improvement (73%) recorded for the high-dose right unilateral group. Thirteen patients experienced remission from depression and nine did not. Heikman et al.

  • Page 16: Safety Of The Thymatron® Ect Device

    Thymatron System IV Instructions for Use ® The authors hypothesized but did not establish a cause of the low efficacy. Ranjkesh et al (2005) randomly assigned 39 DSM-IV patients with major depression to receive courses of 8 bifrontal, bitemporal, or right unilateral ECT with a Thymatron® DGx ECT device. Blindly-obtained Hamilton Depression scale ratings at baseline and after the 8th ECT revealed 73% improvement overall.
  • Page 17 Thymatron System IV Instructions for Use ® improvement, which was not true for neuroinflammatory changes as measured by hippocampal metabolites. The authors concluded that structural, but not metabolic, changes in the left medial temporal lobe are useful neuroimaging biomarkers of ECT-induced clinical improvement in treatment-resistant depression. Cano et al.

  • Page 18: Memory And Cognitive Risks

    Thymatron System IV Instructions for Use ® neuron-specific enolase in 19 patients with depression at baseline and throughout courses of ECT administered with a Thymatron® System IV ECT device. Protein S-100 and enolase levels remained stable throughout the treatment course, demonstrating no neuronal cell injury markers in patients receiving ECT. Sartorius et al.
  • Page 19 Thymatron System IV Instructions for Use ® retesting at this follow-up. There were no statistically significant changes from baseline to 6 months post-ECT in any of the neuropsychological assessments (visual memory, verbal memory, delayed recall, and executive function). In examinations of patient-level data, cognition significantly improved in 14% of patients and significantly declined in 12%.

  • Page 20: References

    Thymatron System IV Instructions for Use ® domains examined. Falconer et al (2010) treated 24 patients with severe depression with a course of bilateral ECT administered with a Thymatron® DGx device. Patients were assessed before ECT, during ECT, within the week after ECT and 1 month after ECT with a battery of visual memory tests including spatial and pattern recognition memory, pattern-location associative learning, and delayed matching.
  • Page 21 Thymatron System IV Instructions for Use ® Ćusa BV, Klepac N, Jakšic N, et al. The Effects of Electroconvulsive Therapy Augmentation of Antipsychotic Treatment on Cognitive Functions in Patients With Treatment-Resistant Schizophrenia. J ECT 2018; 34:31-34. Doddi SR et al (2018). Electroconvulsive Therapy in a Patient With a Recent Subarachnoid Hemorrhage. J ECT 34: e2–e4 Dybedal GS et al (2015), The Role of Baseline Cognitive Function in the Neurocognitive Effects of Electroconvulsive Therapy in Depressed Elderly Patients.
  • Page 22 Thymatron System IV Instructions for Use ® survey. Psychiatry Res. 2011;187:145-9. Kellner CH, Fink M, Knapp R, et al (2005), Relief of expressed suicidal intent by ECT: a consortium for research in ECT study. Am J Psychiatry 162:977-82. Kellner CH, Knapp RG, Petrides G et al (2006), Continuation electroconvulsive therapy vs. pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE).
  • Page 23 Thymatron System IV Instructions for Use ® millisecond) Versus Brief-Pulse (0.50 millisecond) Bilateral Electroconvulsive Therapy in Major Depression. J ECT 27: 55-58 Nuninga JO, Claessens TFI, Somers M et al (2018), Immediate and long-term effects of bilateral electroconvulsive therapy on cognitive functioning in patients with a depressive disorder. J Affective Dis 238:659-665.
  • Page 24 Thymatron System IV Instructions for Use ® Tran DV, Meyer JP, Farber KG et al (2017), Rapid Response to Electroconvulsive Therapy: A Case Report and Literature Review. J ECT 33: e20–e21 van Oostrom et al (2018), Decreased Cognitive Functioning After Electroconvulsive Therapy Is Related to Increased Hippocampal Volume: Exploring the Role of Brain Plasticity.

  • Page 25: Disclaimer / Warranties

    ® DISCLAIMER / WARRANTIES Please note that nothing in this manual constitutes, or should be construed as, a claim by Somatics LLC that confusion, cognitive impairment, or memory loss (short-term, long- term, recent, remote, transient, or persistent), or structural brain change (brain injury) cannot occur as the result of ECT or the general anesthesia administered with ECT.

  • Page 26: Specifications

    Thymatron System IV Instructions for Use ® SPECIFICATIONS STIMULUS OUTPUT Current: 0.9 amps constant current, limited to 450 volts, isolated from line current Frequency: 10 to 70 Hz, in 10 Hz increments (to 140 Hz in LOW 0.25/0.3 Programs) Pulsewidth: 0.25 to 1.5 ms, in 0.25 ms increments (0.3 ms is available) Duration: 0.08 to 8.00 s in increments of equal charge Maximum output: Standard maximum output across 220 ohms impedance, 504 mC (99.8 joules).
  • Page 27 Thymatron System IV Instructions for Use ® Seizure Quality Measures: Postictal Suppression Index (EEG): range, 0-100% Average Seizure Energy Index (EEG) Maximum Sustained EEG Power and Time to Peak EEG Power Maximum Sustained EEG Coherence and Time to Peak EEG Coherence Duke University EEG Measures Power Spectral Analysis by Fast Fourier Transform, (FFT) Peak Heart Rate: beats/min...

  • Page 28: Explanation Of Signs And Symbols

    Thymatron System IV Instructions for Use ® EXPLANATION OF SIGNS AND SYMBOLS FRONT PANEL Warning note: Caution observe accompanying paperwork Defibrillation proof applied part type BF (“Body Floating”). B-The device has a special protection against electric shock, especially in regard to the permissible leakage current and the reliability of the protective earth conductor connection F-The device has and insulated (floating) application part.

  • Page 29: Installation

    Thymatron System IV Instructions for Use ® INSTALLATION Unpack the instrument, open the black case, and place the instrument on a firm, flat surface such as a hospital cart. Check the instrument for any damage, and make sure the rear panel voltage designation matches that of the electrical outlet to be used.

  • Page 30: Percent Energy Dial

    Thymatron System IV Instructions for Use ® PERCENT ENERGY DIAL The PERCENT ENERGY dial is used to select the treatment stimulus dose. This dial has three functions that are displayed in the 4 character L.E.D. above the dial. 1. Rotating the dial displays the PERCENT ENERGY settings for each stimulus dose, followed by a brief display of the corresponding stimulus charge in mC.

  • Page 31: Safety Monitor Circuit Alarm Test

    Thymatron System IV Instructions for Use ® The 4-character L.E.D. is located above the PERCENT ENERGY dial. • It displays the different PERCENT ENERGY values as the dial is rotated. It then briefly displays the mC of charge corresponding to each PERCENT ENERGY dial setting. •...

  • Page 32: Front Panel Jacks

    Thymatron System IV Instructions for Use ® until it has been examined and cleared by authorized biomedical personnel. FRONT PANEL JACKS ECT Stimulus Jack This 2-pin jack labeled “ECT” is located below and to the left of the IMPEDANCE TEST button. It accepts the plug from the ECT stimulus cable.
  • Page 33 Thymatron System IV Instructions for Use ® NOTE: Pressing the FlexDial™ will select the above program being displayed. Once a function or option is selected with the FlexDial™ it remains in effect until changed, even when the unit is powered off. To Exit FLEXDIAL™...
  • Page 34 Thymatron System IV Instructions for Use ® 4. Rotate the FlexDial™ to flash-display the options, EMG-ECG or EEG-EEG. 5. Press the FlexDial™ to select the desired option and return to FlexDial™ function level, “CH 3-4”. 6. Press the IMPEDANCE TEST or START/STOP button to lock in the option and to exit the FlexDial™ mode. FLEXDIAL™...

  • Page 35: Paper Loading Instructions

    PAPER LOADING INSTRUCTIONS The Thymatron® System IV printer paper holder is located just below Somatics’ logo on the right side of the front panel. Press the arrow on the top cover release bar to open the printer cover door. Remove the cardboard sheets and place the fan folded paper pad inside.

  • Page 36: Seizure Monitoring Considerations

    ® SEIZURE MONITORING CONSIDERATIONS Somatics’ stick-on, snap monitoring electrodes, [Cat. # EEDS] are ideal for EEG, ECG and EMG monitoring. Their size and rectangular shape facilitate fronto-mastoid and bifrontal application without interfering with the stimulus electrodes. Prepare the skin sites by vigorously rubbing with an alcohol swab and wiping dry.

  • Page 37: Channels 3 & 4 Selection

    Thymatron System IV Instructions for Use ® the channel 4 holes. EMG: The purpose of monitoring EMG is to provide an automated and highly accurate estimate of the motor seizure duration. Apply two monitoring electrodes spaced about 3” apart to a limb that has been cuffed to prevent the effects of the muscle-relaxant drug.

  • Page 38: Impedance Test (For Static Impedance)

    Thymatron System IV Instructions for Use ® necessary for safety. For conventional bitemporal stimulus electrode placement, clean the skin sites over the temples as above. Remove a Thymapad™ from its wrapper and apply it firmly to the bare skin of the temple. Apply a second Thymapad™...

  • Page 39: Mouth Protection

    These risks are mitigated by inserting a mouth protector prior to the electrical stimulus. Somatics' mouth protectors have channels for ventilation and are available in reusable (sterilizable) and single- use types. They are accompanied by instructions for insertion.

  • Page 40: Stimulus Dose Selection

    Thymatron System IV Instructions for Use ® with attached lead-wires is connected to the front panel; and the lead-wires are clipped to the monitoring electrodes. When the IMPEDANCE TEST button is pressed and held, the word “TESTING”, will briefly appear in the 8- digit L.E.D.

  • Page 41: Stimulus Programs: Factory Programmed

    Thymatron System IV Instructions for Use ® 5% increments). Stop rotating the dial at the desired PERCENT ENERGY setting. A 1-second display then appears of the charge (mC) that corresponds to the PERCENT ENERGY setting, followed by a return to the PERCENT ENERGY number.

  • Page 42: Frequency Selection

    Thymatron System IV Instructions for Use ® Press and hold in the PERCENT ENERGY dial at any time to display the stimulus program in effect. Release the dial to return to the PERCENT ENERGY display. FREQUENCY SELECTION When a factory-programmed preset stimulus is in effect, frequency is automatically adjusted for any given PERCENT ENERGY setting.

  • Page 43: Stimulus Titration Procedure

    Thymatron System IV Instructions for Use ® above for bilateral ECT. NOTE: Once a patient obtains a satisfactory seizure with a given PERCENT ENERGY stimulus dose with unilateral ECT, we do not recommend administering subsequent treatments with progressively lower settings in an attempt to deliver the smallest stimulus that will still induce a seizure.

  • Page 44: Typical Course Of Treatment

    Thymatron System IV Instructions for Use ® within about 5% of the established target, keeping in mind the often dramatic rise in seizure threshold across a course of treatment. Lower target values suggest that the treatment was less than fully effective; this might be acceptable for selected patients but is clearly a matter of medical judgment.

  • Page 45: Manic Symptoms

    Thymatron System IV Instructions for Use ® MANIC SYMPTOMS Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for. Manic symptoms can appear during a course of ECT for major depression or catatonia.

  • Page 46: Eeg Seizure Monitoring

    Thymatron System IV Instructions for Use ® EEG SEIZURE MONITORING 1. The Audible EEG™ seizure monitor 2. The EEG paper recording 3. The Ictal Line™ seizure indicator 4. The EEG endpoint and indexes determined values AUDIBLE EEG™ SEIZURE MONITOR This feature operates automatically when the “TREAT” button is pressed and released. The knob marked “VOLUME”...

  • Page 47: Endpoints And Indices

    Thymatron System IV Instructions for Use ® reflects EEG seizure termination, as determined by the Thymatron® System IV. Wait several seconds before pressing the “START/STOP” button to terminate recording because the computer takes that long to process and report the seizure endpoints and indices. ENDPOINTS AND INDICES A unique feature of the Thymatron®...

  • Page 48: Gain And Position Settings

    Thymatron System IV Instructions for Use ® The computer-derived endpoint seizure duration measures, including the Ictal Line™ seizure indicator, are derived solely by calculation and are provided to aid, not replace, the physician’s judgment. It is possible for seizure activity to continue in the brain after any or all of the computer reports indicate seizure termination.

  • Page 49: Turn Off Printing In A Channel

    Thymatron System IV Instructions for Use ® TURN OFF PRINTING IN A CHANNEL To turn off printing in a given channel, set the gain for that channel to “OFF”. If a given channel has been turned off, the other channels should be set to the “AUTO” position in order to evenly space the remaining tracings on the paper.

  • Page 50: Baseline Retention

    Thymatron System IV Instructions for Use ® TIME TO PEAK POWER is the time elapsed from stimulus termination to the point of maximum EEG power. The MAXIMUM SUSTAINED COHERENCE (COH) measure reports the mean value of the 5-second EEG segment with the highest average coherence recorded during the seizure. TIME TO PEAK COHERENCE is the time elapsed from stimulus termination to the point of maximum EEG coherence.

  • Page 51: Printer Paper Speed Selection

    Thymatron System IV Instructions for Use ® MID FREQ Median EEG frequency % DELTA Relative EEG power in the delta bandwidth When EEG FREQ is enabled with one of these options, baseline EEG collection has been obtained and the “READY” message appears, the values are continuously displayed in the 8-character L.E.D. After several seconds, the “READY”...

  • Page 52: Reset Flexdial™ Settings To Factory Values

    Thymatron System IV Instructions for Use ® down which number this specific configuration was saved as, so it can easily be recalled. FLEXDIAL™ SETTING : SET US1 – SET US8 When a user-specified FlexDial™ selection is in force, the “USER SET” dot L.E.D. on the front panel will light. RESET FLEXDIAL™...

  • Page 53: Transferring Data Between A Pc And Thymatron® System Iv

    Thymatron System IV Instructions for Use ® enter any function level and then press the START/STOP button. TRANSFERRING DATA BETWEEN A PC AND THYMATRON® SYSTEM IV The Thymatron® System IV allows the operator either to send data (upload) or to receive data (input or download) from a personal computer.

  • Page 54: Upload Treatment Data Automatically To A Pc

    Thymatron System IV Instructions for Use ® This feature allows for previously recorded treatment data to be sent back to the Thymatron® System IV. Once the data has been received back in the Thymatron® System IV, it can then be reprinted using the “REPRINT” option in the “DATA OUT”...

  • Page 55: Display Eeg/Emg/Ecg On The Pc Screen

    Thymatron System IV Instructions for Use ® Rotate the FlexDial™ until “UPLOAD” is displayed. Press and rotate the FlexDial™ to flash-display the above options. Press the FlexDial™ to select the desired option, usually “LOAD RAW”. Press the “IMPEDANCE TEST” or “START/STOP” button to exit the FlexDial™ mode. After the patient is treated and the end-of-treatment report is printed, the Thymatron®...

  • Page 56: Output Treatment Data Manually

    Thymatron System IV Instructions for Use ® using the patient’s information, if desired and click UPLOAD. From the GENIE™ IV main menu, click on WINDOWS GRAPH and then TOOLS PLAY CONTROL and TOOLS CHANNEL SETTING as above. OUTPUT TREATMENT DATA MANUALLY This feature allows for manual transfer of the treatment data after the end of a given treatment.
  • Page 57 Thymatron System IV Instructions for Use ®...

  • Page 58: Reprint The Last Treatment

    Thymatron System IV Instructions for Use ® REPRINT THE LAST TREATMENT The Thymatron® System IV automatically stores the last treatment in memory. If the recording paper runs out or is damaged, the last treatment can be reprinted using this feature. This “REPRINT” feature also allows for the reprinting of the treatment data just transferred to the Thymatron®...

  • Page 59: Electromagnetic Compatibility (Emc)

    #ERTH Remote Treatment Handle / Cable Use of accessories and cabling other than those specified above, with the exception of those sold by Somatics LLC or its authorized representatives as replacement parts, may result in increased ® CAUTION emissions or decreased immunity of the Thymatron...

  • Page 60: Electromagnetic Emissions

    Thymatron System IV Instructions for Use ® ELECTROMAGNETIC EMISSIONS Guidance and manufacturer’s declaration – electromagnetic emissions Thymatron® ECT Systems are intended for use in the electromagnetic environment specified below. The customer or the user of a Thymatron® System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance...

  • Page 61: Electromagnetic Immunity

    Thymatron System IV Instructions for Use ® ELECTROMAGNETIC IMMUNITY Guidance and manufacturer’s declaration – electromagnetic immunity Thymatron® ECT Systems are intended for use in the electromagnetic environment specified below. The customer or the user of a Thymatron® System should assure that it is used in such an environment. IEC 60601 –...
  • Page 62 Thymatron System IV Instructions for Use ® Guidance and manufacturer’s declaration – electromagnetic immunity Thymatron® ECT Systems are intended for use in the electromagnetic environment specified below. The customer or the user of a Thymatron® System should assure that it is used in such an environment. IEC 60601 –...
  • Page 63 Thymatron System IV Instructions for Use ® absorption and reflection from structures, objects and people.
  • Page 64 Thymatron System IV Instructions for Use ® Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 65 Thymatron System IV Instructions for Use ® For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.
  • Page 66 Quality System Certificate No. 3819575 This Declaration of Conformity covers Thymatron Electroconvulsive Therapy Devices and is valid for all products distributed by Somatics, LLC. bearing the CE mark, including the Thymatron® System IV, starting with serial No. 40020 with serial No. 41950...

  • Page 67: Index

    Thymatron System IV Instructions for Use ® INDEX ADDENDUM I (FIRMWARE CHANGES) 66 FFT 50 ADDENDUM II (ELECTRODE PLACEMENT) 68 FLEXDIAL™ [function] [options] 32 ADDENDUM III (INSTRUCTIONS TO PATIENT) 74 FLEXDIAL™ Functions and What They Control 33 ADDENDUM IV (FLEXDIAL FLOW CHART) 76 FLEXDIAL™...
  • Page 68 Thymatron System IV Instructions for Use ® Precautions 7 STIMULUS DOSE FOR BILATERAL 41 PRINTER PAPER SPEED SELECTION 50 STIMULUS DOSE FOR UNILATERAL 41 PROGRAM SELECTION 40 STIMULUS DOSE SELECTION 39 PULSEWIDTH SELECTION 41 STIMULUS ELECTRODES APPLICATION 36 STIMULUS OUTPUT 25 STIMULUS PROGRAM SELECTION 40 STIMULUS TITRATION 42 REFERENCES 19...

  • Page 69: Addendum I (Firmware Changes)

    Thymatron System IV Instructions for Use ® ADDENDUM I (FIRMWARE CHANGES) History of Firmware Changes to THYMATRON® SYSTEM IV The software version of your Thymatron® System IV is printed at power-up. Each of the following software upgrades includes all previous upgrades. SOFTWARE REQUIRES VERSION...
  • Page 70 Thymatron System IV Instructions for Use ® 5.61 12/1/09 USER programs display up to 70 Hz Reset “USER” mode to last frequency 5.62 09/07/10 5.63 11/03/10 Changed Baseline Validity settings 5.71 03/22/16 Added Driver code for rev B printer & 2X-DGx 5.72 01/10/18 Enabled Restart printer automatically...

  • Page 71: Addendum Ii (Electrode Placement)

    ADDENDUM II (ELECTRODE PLACEMENT) 4 channel setup with Splitter -> 2 EEG, 1EMG, 1 ECG channel* to Thymatron System IV ECT to Thymatron System IV EEG/ECG/EMG *Electrode connections for channel 1, 2 EEG, channel 3 EMG, channel 4 ECG recording...
  • Page 72 Thymatron System IV Instructions for Use ® Electrode Splitter 1• • • • to Thymatron System IV EEG/ECG/EMG...
  • Page 73 System IV Instructions for Use ® 4-channel setup -> 2 EEG, 1 EMG, 1 ECG channel* to Thymatron System IV ECT to Thymatron System IV EEG/ECG/EMG *Electrode connections for channel 1 , 2 EEG, channel 3 EMG, channel 4 ECG recording...
  • Page 74 System IV Instructions for Use ® 3 channel setup -> 1 EEG. 1 EMG, 1 ECG channel* to Thymatron System IV ECT to Thymatron System IV EEG/ECG/EMG *Electrode connections for channel 1 EEG, channel 3 EMG, channel 4 ECG recording...
  • Page 75 Thymatron System IV Instructions for Use ® 2 channel setup -> 1 EEG, 1EMG channel* to Thymatron System IV ECT to Thymatron System IV EEG/ECG/EMG *Electrode connections for channel 1 EEG, channel 3 EMG recording...
  • Page 76 Thymatron System IV Instructions for Use ® 1 channel setup -> 1 EEG channel* to Thymatron System IV ECT to Thymatron System IV EEG/ECG/EMG *Electrode connections for channel 1 EEG recording...

  • Page 77: Addendum Iii (Instructions To Patient)

    Thymatron System IV Instructions for Use ® ADDENDUM III (INSTRUCTIONS TO PATIENT) Safety Information For patients with brain tumor, brain aneurysm, myocardial infarction, coronary insufficiency, heart failure, or aortic aneurysm medical specialists in Neurology or Cardiology should be consulted to determine additional precautions needed, if any. CAUTION When used as intended, this device provides short-term relief of symptoms.
  • Page 78 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 understood to be effective in treating depression and catatonia.

  • Page 79: Addendum Iv (Flexdial Flow Chart)

    Thymatron System IV Instructions for Use ® ADDENDUM IV (FLEXDIAL FLOW CHART)

  • Page 80: Addendum V (Moca Test)

    Thymatron System IV Instructions for Use ® ADDENDUM V (MOCA TEST)

  • Page 81: Addendum Vi (Instructions For Legacy Metal Old Type Stimlus Electrodes)

    Thymatron System IV Instructions for Use ® ADDENDUM VI (INSTRUCTIONS FOR LEGACY METAL OLD TYPE STIMULUS ELECTRODES) In every case, be sure that before giving the electrical stimulus the patient is under anesthesia, the patient's muscles are fully relaxed, oxygen is being administered, ventilation is supported, a mouth protector is in place and the impedance is tested.
  • Page 82 Thymatron System IV Instructions for Use ® With all methods, impedance testing is done with both electrodes firmly applied and the 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.
  • Page 83 ADDENDUM VII. Tables of stimulus details for each % Energy setting of the dose dial. DGX program % Energy Frequency, hz Pulse width, ms Pulse number Duration, sec 0.08 0.17 0.27 0.35 0.45 0.55 0.63 0.73 0.82 0.92 1.02 1.10 1.20 1.28 1.38...
  • Page 84 LOW 0.25 CHARGE RATE program (standard pulsewidth set) % Energy Frequency, hz 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 0.25 0.25 0.25 0.25 Pulse number Duration, sec 1.05 2.20 3.30...
  • Page 85 INTERMITTENT program % Energy Frequency, hz Pulse width, ms Pulse number Duration, sec 0.08 0.27 0.47 0.65 0.85 1.05 1.23 1.43 1.62 1.82 2.02 2.20 2.40 2.48 2.68 2.88 3.07 3.27 3.45 3.65 3.85 4.03 Energy, % Frequency, hz Pulse width, ms Pulse number Duration, sec 4.23...

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