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

Main Page

Table of Contents3
Intended Use7
Intended Patient Population7
Safety Information8
- Warnings8
- Precautions8
Adverse Events10
- Serious Adverse Events11
- Other Risks11
- Risks of Cognitive Memory Effects12
Technique of Ect12
To the Treating Physician13
Risk Reduction Features13
- Risk of Prolonged Seizures and Cardiac Arrhitmias13
- Risk of Thymatron® Component Failure14
Efficacy and Safety of the Thymatron® Ect Device14
- Efficacy of the Thymatron® Ect Device14
- Safety of the Thymatron® Ect Device16
Disclaimer / Warranties25
Specifications26
Explanation of Signs and Symbols28
- Front Panel28
- Rear Panel28
Installation29
Operating Instructions29
- Power On/Off29
- Self Test29
- Percent Energy Dial30
- Light-Emitting Function Displays30
- Safety Monitor Circuit Alarm Test31
- Front Panel Jacks32
- Flexdial™ Operation32
- Paper Loading Instructions35
- Stimulus Cable Connection35
- Monitoring Cable Connection35
- Lead-Wire Connections35
- Seizure Monitoring Considerations36
- Monitoring Electrodes Application36
- Channels 3 & 4 Selection37
- Stimulus Electrodes Application37
- Impedance Test (for Static Impedance)38
- Mouth Protection39
- Baseline Eeg Collection39
- Stimulus Dose Selection40
- Stimulus Programs: Factory Programmed41
- Stimulus Program Selection41
- Frequency Selection42
- Pulsewidth Selection42
- Stimulus Dose for Bilateral, Bitemporal, Bifrontal, Lart Ect42
- Stimulus Dose for Unilateral Ect42
- Stimulus Titration Procedure43
- Benchmark" Method for Setting and Adjusting Stimulus43
Typical Course of Treatment44
- Tardive Seizure44
- Worsening of Psychiatric Symptoms44
- Manic Symptoms45
- Treatment Stimulus Administration45
- Seizure Monitoring45
- Gain and Position Settings48
- Turn off Printing in a Channel49
- Changing Eeg Gain Rapidly49
- Seizure Quality Measures49
- Baseline Retention50
- To Enable/Disable Seizure Quality Measures50
- Eeg Frequency Measures50
- Printer Paper Speed Selection51
  - Turn off Printing Entirely51
- Power Spectral Analysis (Fft) Selection51
- User Specified Flexdial™ Selections51
  - Reset Flexdial™ Settings to Factory Values52
- Transferring Data between a Pc and Thymatron® System IV53
Electromagnetic Compatibility (Emc)59
- General Notes59
- List of Cables and Accessories59
- Electromagnetic Emissions60
- Electromagnetic Immunity61
Index67
Addendum I (Firmware Changes)69
Addendum II (Electrode Placement)71
Addendum III (Instructions to Patient)77
Addendum IV (Flexdial Flow Chart)79
Addendum V (Moca Test)80
Addendum VI (Instructions for Legacy Metal Old Type Stimlus Electrodes)81

Somatics Thymatron System IV - User Manual

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