THYMATRON SYSTEM IV Instruction Manual Rev 10 Sept 2004

TABLE OF CONTENTS TOPIC

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Specifications……………………………………………. 3 Indications for Use ………………………………………4 Installation………………………………………………. 5 Operating Instructions…………………………………. 5 Percent Energy Dial……………………………………. 6 Safety Monitor Test…………………………………….. 7 FlexDial™ Operation………………………………….. 8 FlexDial™ Model Procedure………………………….. 9 FlexDial™ Flow Chart...11 Paper Loading Instructions……………………………. 12 Monitoring Electrodes Application……………………. 13 Stimulus Electrodes Application………………………. 16 Impedance Test…………………………………………. 17 Baseline EEG Collection……………………………….. 18 Stimulus Dose Selection………………………………... 19 Stimulus Programs, Factory Programmed…………… 19 Treatment Stimulus Administration………………….. 23 Seizure Monitoring, EEG……………………………… 23 Ictal Line™ Indicator………………………………….. 24 Gain and Position Settings…………………………….. 25 Change EEG Gain Rapidly…………………………….. 26 Seizure Quality Measures……………………………… 26 Anesthesia Depth Monitoring………………………….. 27 Printer Paper Speed……………………………………. 27 User Specified FlexDial™ Selections…………………. 28 Reset to Factory Specifications……………………….. 28 Transferring Data to PC………………………………. 29 Input Hospital’s Name………………………………… 29 Upload Treatment Data……………………………….. 30 Monitor EEG/ECG/EMG on PC……………………… 31 Reprint Last Treatment……………………………….. 33 Set Date and Time……………………………………… 33 Table 1, Standard Dose Parameters………………….. 34 Table 2, Double Dose Parameters…………………….. 47 Addendum I, Software Updates………………………. 50 EC Declaration of Conformity………………………… 51 Index…………………………………………………….. 52

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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 with LOW 0.25 Program) Pulsewidth: 0.25 to 1.5 ms, in 0.25 ms increments Duration: 0.14 to 7.99 s in increments of equal charge Maximum output: Standard maximum output across 220 ohms impedance, 504 mC (99.4 joules). Output for double dose mode (where available) across 220 ohms impedance: 1008 mC (198.8 joules) Actual (delivered) treatment output shown on printed report in mC RECORDING 4 recording 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 Impedance Test: 0 to 3000 ohms static (+/- 100 ohms) at 800 Hz (L.E.D. and printed report) Dynamic Impedance Measure: 0 - 500 ohms (printed report) SEIZURE MONITORING Channel specifications: Maximum gain: EEG, 10 µV/cm; EMG 50 µV/cm; ECG 50 µV/cm Common mode rejection: 80 dB Isolation: full, opto-electronic Printer paper speed: user selectable: 5 - 50 mm/s 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

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Duke University EEG Measures Power Spectral Analysis by Fast Fourier Transform, (FFT) Peak Heart Rate: beats/min Computer Seizure Endpoint Estimates by EEG and EMG ANESTHESIA DEPTH MONITOR MEASURES 95% Spectral Edge Frequency Median Frequency Relative Delta Power DIMENSIONS Weight: 22 lb Height: 5.5” Width: 17.5” Depth: 13.0” INDICATIONS FOR USE We recommend that doctors planning to use the Thymatron® System IV read and follow the recommendations of the Task Force Report of the American Psychiatric Association as set forth in “The Practice of Electroconvulsive Therapy” (American Psychiatric Association, 2001). To briefly summarize these recommendations here, the Thymatron® System IV is intended to be used to administer electroconvulsive therapy (ECT) to patients suffering from mental disorders in which a rapid, definitive response is desired. ECT is most often indicated in patients who have not responded to adequate courses of appropriate pharmacotherapies, but is also indicated as the primary treatment for patients in whom a rapid or high probability of response is desired (as when they are severely medically ill or in danger of harming themselves) or who are known by their treatment history to respond only to ECT, or who have expressed a valid preference for ECT over alternate therapies. PATIENT SELECTION CRITERIA The principal diagnostic indications for ECT as outlined in the Task Force Report of the American Psychiatric Association (APA, 2001) are Major Depression (all types), Mania, and Schizophrenia (characterized by abrupt or recent onset, catatonic features, psychotic symptoms, or a history of ECT response). CONTRAINDICATIONS AND WARNINGS The Task Force Report of the American Psychiatric Association (APA, 2001) recognizes no absolute medical contraindication to ECT. It does warn about specific conditions that may be associated with substantially increased risk, including unstable or severe cardiovascular conditions (recent myocardial infarction, unstable angina, poorly-compensated congestive heart failure, severe

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valvular cardiac disease), vascular aneurysms susceptible to rupture with increased blood pressure, increased intracranial pressure, recent cerebral infarction, severe chronic obstructive pulmonary disease, asthma, pneumonia and anesthesia risk level ASA 4 or 5. 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. Determine that all manuals and items are present. If required, have the Safety Check performed as described in the Service Manual, Section 2. Connect the power cable to the rear of the unit. Power the unit on and observe that the POWER switch light comes on, the self test runs successfully and “BASELINE” is displayed. Load a pad of thermal paper as per the instructions inside the paper door (see page 12). Turn the power switch off and on again to verify that the recorder prints the date and software version. This completes the installation. OPERATING INSTRUCTIONS The new Thymatron® System IV features two front panel controls for display and selection of all treatment choices: the PERCENT ENERGY stimulus dose dial and the FLEXDIAL™ function and option selector. In addition, you will see a POWER switch (power on/off), an IMPEDANCE TEST button, a START/STOP button (to manually control 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). POWER ON/OFF Be sure the power cable is plugged into a grounded, 3-prong hospital-grade socket. Press the top half of the front-panel POWER switch (labeled “I”) to turn the unit on; press the bottom half of the POWER switch (labeled “0”) to turn the unit off. SELF TEST The Thymatron® System IV incorporates an automatic self-test feature that tests the integrity of all circuits. When the unit is first powered on, a flashing nonsense symbol first appears for several seconds in the 8-character L.E.D., followed by the flashing message “SELFTEST” for a few more seconds, after which a self-test confirmation report is printed and the words “NO BASE” appear in the 8-character

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L.E.D., indicating that baseline EEG collection still has yet to be accomplished. (See IMPEDANCE TEST procedure section for initiating baseline EEG collection.) The printed SELF TEST confirmation report will appear on the paper strip as: Thymatron System IV

S/N [serial number here]

Date - Time S-IV version [software version] / [the number 60 or 50 Hz] The Thymatron® S/N line can be replaced with the hospital’s name (see page 30). 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. 2. Pressing the dial displays the stimulus program currently in effect. 3. Pressing, holding in and then rotating the dial enables the operator to rapidly change stimulus programs without using the FlexDial™. To display the corresponding charge in mC again, rotate the PERCENT ENERGY dial in either direction and then back again to the desired setting. LIGHT-EMITTING FUNCTION DISPLAYS The Thymatron® System IV front panel has two alphanumeric L.E.D.s (the left one, with 8 characters, and the right one with 4 characters), plus 5 individual dot L.E.D.s 8-character L.E.D. Located above the IMPEDANCE TEST button 1. It displays the message “SELFTEST” immediately after the unit is powered on. 2. It displays the message “NO BASE” following completion of the self-test procedure and before baseline EEG collection has been initiated. 3. It displays the message “TESTING” for 1 second when the IMPEDANCE TEST button is pressed. 4. It then displays the static impedance value in ohms, and maintains it until the button is released. 5. It displays the message “BASELINE” from the time the IMPEDANCE TEST button is released until baseline EEG is obtained, about 6-10 seconds. 6. It displays the message “READY” when baseline EEG collection has been successfully accomplished. 7. After the “TREAT” button is pressed and released, it shows the time elapsed in seconds since the end of the treatment stimulus. 8. It displays the flashing message “REPORT” when the START/STOP button is pressed to generate and print the end-of-treatment report. 9. It displays the designations and values of all FlexDial™ functions and options during their selection.

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4-character L.E.D.

Located above the PERCENT ENERGY dial

1. It displays the different PERCENT ENERGY values as the dial is rotated. 2. It then briefly displays the mC of charge corresponding to each PERCENT ENERGY dial setting. 3. It displays the stimulus program in effect when the dial is pressed. 4. It displays the options for the stimulus programs when the dial is pressed, held in and rotated. Releasing the dial, selects that program. Dot L.E.D.s Located on the front panel 1. The L.E.D. labeled “FLEXDIAL” flashes when the FlexDial™ mode is activated. 2. The L.E.D. labeled “SAFETY MONITOR ACTIVATED” flashes when the Safety Monitor has been activated. 3. The L.E.D. labeled “PRESET” lights when the LOW 0.5 program is in effect. 4. The L.E.D. labeled “USER SET” lights when a user set selection is in effect. 5. The L.E.D. directly above the “EEG/ECG/EMG” monitoring jack stays lit unless channel 4 is being used to monitor the patient’s ECG. When channel 4 is connected, the light goes off. 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 stimulus cable banana plugs to a 200 ohm, 10 watt load resistor (or insert these banana plugs into the designated jacks of the ECTOBRAIN™ II testing device). 4. First press and hold down the rear panel “ALARM TEST” button. Next, press and hold the “TREAT” button, and then release the “ALARM TEST” button. 5. Continue pressing the “TREAT” button while the Thymatron® System IV goes through the full cycle of stimulus warning signal and stimulus indicator tones, then release the “TREAT” button. At the end of the stimulus indicator tones the “SAFETY MONITOR ACTIVATED” dot L.E.D. will go on and a high-pitched, continuous signal tone will sound until the unit is powered off. This shows the alarm signal is operating correctly. If the indicator light and alarm signal tone do not occur, do not use the unit to treat patients until it has been examined and cleared by authorized biomedical personnel.

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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. EEG/ECG/EMG Monitoring Jack This 9-pin jack labeled “EEG/ECG/EMG” is located below and to the right of the IMPEDANCE TEST button. It accepts the plug from the EEG/ECG/EMG monitoring cable. NOTE: It is impossible to insert the plug from the stimulus cable into the monitoring jack, and vice versa. Do not force the wrong cable in, as it could break the connector. FLEXDIAL™ OPERATION The FlexDial™ has 18 different user-selectable functions, plus the ability to change EEG gain while the printer is running. All functions and options can be displayed, then selected with alternating rotations and presses of the FlexDial™, according to the following 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 8character L.E.D. and advances to the next choice. 3. Pressing, holding in, and rotating the FlexDial™ while the printer is running allows the operator to rapidly change the gain in all EEG channels. TO ENTER FLEXDIAL™ MODE: With power on, press the FlexDial™. The most recently selected function in the “SETTING” level will appear in the 8-character L.E.D. The FlexDial™ dot L.E.D. will flash to indicate that you are now in the FlexDial™ mode. These function headings (e.g., “SETTING”, “PROGRAMS”, “INDEXES”, etc.) do not change a particular setting, but are the FlexDial™ locations from which to select a range of related options. For example, selecting the “PROGRAMS” function, leads you to the options of: the traditional DGx program, three Low Charge Rate programs, the Intermittent (Pulse Volley) stimulus mode, the double dose program (where available) and the USER mode. 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. 8

TO EXIT FLEXDIAL™ MODE: There are two ways to exit FlexDial™ mode: Pressing the START/STOP button of the printer or pressing the IMPEDANCE TEST button. The FlexDial™ dot L.E.D. will stop flashing upon exit. 1. Pressing the START/STOP button locks in the selection, generates a printed report of the 13 FlexDial™ selections in effect and exits the FlexDial™ mode. 2. Pressing the IMPEDANCE TEST button locks in the selections and exits the FlexDial™ mode without generating a printed report. FLEXDIAL™ MODEL PROCEDURE For 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] 1. 2. 3. 4. 5.

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 function. Rotate the FlexDial™ to flash-display the other options. Press the FlexDial™ to select the desired option and advance to the next option (if there is one) or to return to FlexDial™ function level. 6. Press the IMPEDANCE TEST or START/STOP button to lock in the option and to exit the FlexDial™ mode.

Example:

FLEXDIAL™
CH 3-4
EMG-ECG, EEG-EEG means 1. Press the FlexDial™ to display the most recently-adjusted FlexDial™ function. 2. Rotate the FlexDial™ in either direction to display the “CH 3-4” function. 3. Press the FlexDial™ to flash-display the option in effect. 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.

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FLEXDIAL™ FUNCTIONS AND WHAT THEY CONTROL FLEXDIAL™ FUNCTION SELECTS THESE OPTIONS SETTING CHANN. 1 CHANN. 2 CHANN. 3 CHANN. 4 FREQUENC P-WIDTH PROGRAMS SAVE USR CH 3-4 ENDPOINT INDEXES EEG FREQ PRINTOUT UPLOAD DATA OUT DATA IN CLOCK

Resets to factory specifications, loads up to 8 user set selections Channel 1 gain and position settings Channel 2 gain and position settings Channel 3 gain and position settings Channel 4 gain and position settings Stimulus frequency (10 Hz – 70 Hz in 7 steps) Stimulus pulsewidth (0.25 ms – 1.5 ms in 6 steps) Selects from 6 factory pre-programmed stimulus programs Stores up to 8 user set selections Enables channels 3-4 to monitor either EMG-ECG or EEG-EEG Enables endpoint detection, HR measures, prolonged seizure alert signal Enables seizure quality measures Enables the Anesthesia Depth Monitor, selects measures Enables printer and FFT printout, sets paper speed Enables sending treatment data to a PC automatically Reprints treatment just given; sends treatment data to PC Accepts hospital’s name from PC for the printed report; Accepts treatment data for re-printing treatment record Sets month, day, year, hour, and minute on printed report

Additionally, pressing, holding in, and rotating the FlexDial™ while the thermal printer is running will change the gain in all EEG monitoring channels.

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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. Make sure the black squares are on the right side and the warning strips on the bottom of the pad. Fold over the top sheet and feed these double sheets into the printer, just below the roller. The printer will automatically advance the paper to the correct point and stop. Press and release the START/STOP button to feed a sheet of paper. STIMULUS CABLE CONNECTION Connect the plug of the black ECT stimulus cable into the jack labeled “ECT”, located on the lower left front panel. MONITORING CABLE CONNECTION Connect the plug of the gray EEG/ECG/EMG monitoring cable into the jack labeled “EEG/ECG/EMG”, located on the lower left front panel, just to the right of symbol of the human figure inside a box. NOTE: For safety, it is impossible to insert the plug from one cable into the jack for the other. Do not force the wrong cable in, as it could break the connector. LEAD-WIRE CONNECTIONS The Thymatron® System IV is shipped with 9 standard length (24 inch) lead-wires: 4 red, 4 black, and 1 green. Also included are 2 extra length (60 inch) brown leadwires for recording EMG from the leg, if desired. Any combination of channels (from 1 to 4) can be used to monitor the patient. Not all channels need to be used. However, channel 1 must be used to obtain baseline EEG and seizure endpoints. Plug the red lead-wires into the receptacles for channels 1, 2, 3 & 4 indicated by red dots at the flared end of the gray monitoring cable, and plug the black lead-wires into the corresponding receptacles for channels 1, 2, 3 & 4 indicated by black dots. Plug the green lead-wire into the green receptacle marked “Iso Gnd”. If monitoring EMG from the leg, insert the brown lead-wires into the channel 3 receptacles (in any order) instead of the red and black lead-wires. (The ordinary lifespan of a lead-wire is one year. With infrequent use some will last longer. Replacement lead-wires are available separately from the entire monitoring cable.)

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MONITORING ELECTRODE APPLICATION Somatics’ stick-on, snap monitoring electrodes, [Cat. # EEDS] are ideal for EEG, ECG and EMG monitoring. Their size and rectangular shape facilitate bifrontal and fronto-mastoid application without interfering with the stimulus electrodes. Prepare the skin sites by vigorously rubbing with an alcohol swab and wipe dry. EEG Monitoring Electrodes: You can choose to monitor up to 4 channels of EEG. Two-channel EEG monitoring is standard and can provide specific evidence for interhemispheric seizure generalization. Four-channel EEG monitoring is primarily used for research. Channel 1 must be used to obtain baseline EEG and to determine the EEG endpoint and the EEG indexes. For 1-channel EEG monitoring from the forehead alone, place a stick-on monitoring electrode at the left lateral border of the forehead and another above the medial border of the right eye. This is because symmetrical placement of the two EEG electrodes greatly diminishes low frequencies on the EEG. For the frontomastoid EEG placement, place one monitoring electrode just above an eyebrow and the other electrode over the ipsilateral mastoid bone. A single fronto-mastoid placement over the non-stimulated (left) hemisphere when giving right unilateral ECT helps to confirm generalization of the seizure. Apply a monitoring electrode to either shoulder as a patient ground. Connect the channel 1 lead-wire clips to the EEG monitoring electrodes in any order of polarity and connect the green lead-wire clip to the ground electrode. For 2-channel EEG monitoring, the classic fronto-mastoid placements are recommended. Place a monitoring electrode just above an eyebrow and another electrode over the ipsilateral mastoid bone, on the same side of the head. Repeat this for the other side of the head. Connect the channel 1 lead-wire clips to the first pair of EEG monitoring electrodes in any order of polarity (red or black). Then connect the channel 2 lead-wire clips to the second pair of EEG monitoring electrodes in the same order. (E.g., if a red clip is connected to the channel 1 supra-orbital monitoring electrode, connect the red clip to the channel 2 supra-orbital monitoring electrode, maintaining the polarity.) Apply a monitoring electrode to either shoulder as a ground and connect it to the green lead-wire clip. For 3- or 4-channel EEG monitoring, use the electrode placements of your choice, remembering to keep the polarity (relationship of red and black lead-wires) consistent for corresponding channels on each side of the head. If you connect the red and black lead-wires to frontal and temporal monitoring electrodes, respectively, on the 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.

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ECG Monitoring Electrodes: You can monitor ECG only from channel 4. Apply two monitoring electrodes over the anterior chest above and below the heart, spaced about 8” apart. Connect the channel 4 lead-wires from the monitoring cable to the precordial electrodes in any order of polarity. The ground lead-wire used for EEG, as described above, is also the ground for the ECG. If only ECG is being monitored, then apply the ground green lead-wire to the patient’s shoulder electrode. EMG Monitoring Electrodes: You can monitor EMG only from channel 3. Apply two monitoring electrodes spaced about 3” apart to a limb that has been cuffed to prevent the effects of the muscle-relaxant drug. Connect the channel 3 red and black lead-wires in any order of polarity to monitor from the patient’s arm. Use the pair of brown 60 inch lead-wires to monitor from the patient’s foot. If you are already monitoring from another channel, the same ground lead will serve for EMG. If only EMG is being monitored, then apply a green lead-wire to the patient’s shoulder electrode as a ground. NOTE: The “cuffed limb” method relies on observing the motor manifestations of the cerebral seizure activity in a limb that has been blocked from the effects of the musclerelaxant agent (e.g., succinylcholine) by inflation of a blood pressure cuff over the biceps or calf to just above systolic pressure immediately prior to succinylcholine administration. As soon as the seizure ends, deflate the blood pressure cuff. With this method, the EMG electrodes are applied either on the forearm or dorsum of the foot. CHANNELS 3 & 4 SELECTION EEG is always monitored from channels 1 & 2 and they are not user selectable. Channels 3 & 4 can monitor either EMG/ECG or two more channels of EEG. To select the monitoring options for channels 3 & 4, follow the procedure below:

FlexDial™
CH 3-4
EMG-ECG; EEG-EEG

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to Thymatron System IV-ECT

on mastoid

Iso

Ch 1

2

3

4

Gnd

to Thymatron System IV-EEG/ECG/EMG

Electrode connections for channel 1-2 EEG, channel 3 EMG, channel 4 ECG recording

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STIMULUS ELECTRODE APPLICATION Apply the Thymapad™ adherent stimulus electrodes [Cat. # EPAD] supplied with the Thymatron™ System IV, according to the directions, “Use of Thymapad™ Disposable ECT Stimulus Electrodes”. Clean the patient’s skin sites by rubbing vigorously with a saline moistened swab and pat dry. Do not use solvents (e.g., alcohol) with Thymapad™ stimulus electrodes. Spread 1-2 drops of Pre-Tac solution over the site and rub into the skin with a fingertip until dry. Remove a Thymapad™ from its wrapper, peel it from the plastic backing, and apply it firmly to the bare skin. Insert the banana plug from the ECT stimulus cable into the plastic receptacle at the end of each Thymapad™ wire, until the entire conducting surface of each banana plug is covered and no metal shows. Press firmly once more on each Thymapad™ to ensure that it is properly applied and then test impedance. 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™ to the other temple. For bifrontal placement, place the center of each Thymapad™ 5 cm above the lateral angle of each orbit, about 14-15 cm apart. Before peeling the Thymapad™ from the backing, bend it to match the shape of the skull at each electrode site. For Swartz’ left-anterior right-temporal (LART) placement, place the left-sided Thymapad™ above the left eye, with its lateral edge bordering the bony ridge between the forehead and the temple. Before peeling the left Thymapad™ from its backing, bend it to match the forehead’s curve. Place the right frontotemporal electrode exactly as described above for bitemporal ECT. For right unilateral stimulus electrode placement, the d’Elia placement is recommended. Clean and dry the skin 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 scalp area directly under the electrode. Apply a Thymapad™ to the site, holding it firmly in place with the special foam handle applicator supplied. (If the patient is bald at the near-vertex site, the upper Thymapad™ can be applied directly to the bare scalp after cleaning and drying as described above.)

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IMPEDANCE TEST (FOR STATIC IMPEDANCE) Be sure the front panel POWER button is on, the ECT stimulus cable connected to the front panel and both stimulus electrodes are firmly applied. Press the front panel IMPEDANCE TEST button and observe the static impedance displayed in ohms, in the 8-digit L.E.D. Repeatedly checking impedance does not prevent ongoing monitoring or affect baseline EEG collection.

CAUTION: DO NOT PRESS THE “TREAT” BUTTON WHEN TESTING THE IMPEDANCE The static impedance test checks the quality of the skin-to-electrode contact. With the Thymatron™ System IV, the static impedance should be greater than 100 ohms and less than 3000 ohms before the treatment stimulus dose is administered. A static impedance reading of less than 100 ohms suggests a short circuit, probably in the stimulus cable. An impedance reading of 3000 ohms or more appears as the flashing number 3000; if this occurs the impedance should be reduced by the following steps: a) Try pressing firmly on each Thymapad™ again while testing the impedance. This is especially important for the vertex electrode with unilateral ECT, which should be pressed vigorously in place with the foam handle applicator provided. Also for unilateral ECT, make sure that the hair and scalp under the vertex stimulus electrode are thoroughly moistened with a saline-soaked pad. b) If necessary, remove the Thymapad™, pass it under running water, shake off the excess water, wait a few minutes and then reapply the Thymapad™ by pressing it firmly into place. c) Check to make sure the electrodes have not slipped or twisted. d) Reposition the stimulus electrodes to minimize the amount of hair underneath. e) Increase pressure on the stimulus electrode by pressing harder with the foam handle applicator. f) Gently rub 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 thickens and hardens, causing the static impedance to rise. Also, some patients have high readings despite all procedures. Try applying Aloe Vera skin lotion [Cat. # UP235N] to the electrode sites between treatments and shortly after waking on ECT days. If the static impedance reading remains >3000 ohms after trying the above procedures, try replacing each Thymapad™, the lead-wires or the stimulus cable, in that order.

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BASELINE EEG COLLECTION Prior to collecting a baseline EEG, be sure the automatic EEG endpoint detection feature of the Thymatron® System IV is enabled; the EEG monitoring electrodes are properly applied to the patient; the monitoring cable 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. Then a number ranging from 0 to >3000 ohm, representing the static impedance, will appear. When the IMPEDANCE TEST button is released, the number is replaced by the message “BASELINE”. The “BASELINE” message indicates that baseline EEG collection is in progress. When baseline EEG collection has been accomplished, the word “READY” will appear in the L.E.D. It normally takes about 6-10 seconds for “READY” to appear. However, moving the patient’s head, touching or moving the monitoring electrodes, lead-wires, or monitoring cable during baseline EEG collection will prolong the process by introducing EEG artifact. The less the patient and monitoring connections are moved or touched during baseline EEG collection, the sooner the “READY” message will appear and the patient will be ready to treat. If necessary, stop ventilating the patient for the few seconds it takes for the “READY” message to appear. Place the lead-wires so that they will not be disturbed by the anesthetist. Each pair of wires can be taped together about every 6 inches to minimize movement and artifact. NOTE: If the “READY” message does not appear before the treatment stimulus dose is administered, there will be neither an Ictal Line™ nor EEG endpoint determinations or seizure quality measurements because an adequate baseline was not obtained. 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. Repeated pressing of the IMPEDANCE TEST button does not interfere with baseline EEG collection. TIP: It is strongly recommended to initiate baseline EEG collection by pressing the IMPEDANCE TEST button on the Thymatron® System IV’s front panel as soon as the monitoring electrodes and a ground electrode have been applied, even before applying the Thymapad™ stimulus electrodes (e.g., while the patient is fully awake and before anesthesia has been administered). This will provide the longest possible period of baseline EEG collection, maximizing the likelihood that a good baseline will be collected by the time the treatment stimulus is administered.

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STIMULUS DOSE SELECTION The Thymatron® System IV is shipped with the LOW 0.5 program enabled. This is the recommended choice for the first treatment in all patients for whom there is no prior information concerning ECT response or seizure threshold. When desired, the FlexDial™ can be used to select stimulus parameters specifically tailored to the patient’s established requirements, or to select from among other factory- or userset stimulus programs. However, we recommend use of the LOW 0.5 program wherever possible, because it provides a broadly effective stimulus that is in the physiological range for most patients. Rotate the PERCENT ENERGY dial to display the available stimulus settings (range: 5% to 100% ENERGY in 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. NOTE: The stimulus dose in mC that corresponds to any PERCENT ENERGY figure shown in the L.E.D. can be viewed again for 1 second by rotating the PERCENT ENERGY dial to either side and then back again. Because stimulus duration is limited to a maximum of 8 seconds, the higher PERCENT ENERGY settings may not be available when the user selects pulsewidth or frequency values at the lower end of their ranges. Whenever the PERCENT ENERGY setting for a given pulsewidth and frequency would deliver a stimulus exceeding 8 seconds, the message “>8 S” will appear, followed by a display of the PERCENT ENERGY delivered for the specified parameters. However, all the factory-programmed preset programs shown in the next paragraph will work at all PERCENT ENERGY settings. Table 1 shows all the standard dosages and stimulus parameters for each PERCENT ENERGY setting. STIMULUS PROGRAMS: FACTORY PROGRAMMED There are 6 factory stimulus programs listed below. The three “LOW” programs automatically adjust the frequency to provide the longest stimulus duration available for a given PERCENT ENERGY setting, thus 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. DGX LOWEST LOW 0.25 LOW 0.5 INTERMIT 2X DOSE

Reproduces the standard stimulus of the Thymatron® DGx Automatically adjusts parameters to provide the lowest charge rate Fixed 0.25 ms pulsewidth varies frequency to maximize duration Fixed 0.5 ms pulsewidth, varies frequency to maximize duration Intermittent pulse-volley stimulus mimics the Siemens Konvulsator Double dose stimulus program (not available in USA or Canada)

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STIMULUS PROGRAM SELECTION Any standard (factory-programmed) setting can be selected using the procedure listed below. Or, to quickly change programs without the FlexDial™, press, hold in and rotate the PERCENT ENERGY dial. Releasing it selects the program displayed.

FLEXDIAL™
PROGRAMS
DGX, LOWEST, LOW 0.25, LOW 0.5, INTERMIT, 2X DOSE, USER 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. Selecting a specific frequency takes the Thymatron® System IV out of any preset program. To select a specific stimulus frequency:

FLEXDIAL™
FREQUENC
10, 20, 30, 40, 50, 60, 70 Hz PULSEWIDTH SELECTION When a factory-programmed preset stimulus is in effect, the pulsewidth is automatically adjusted for any given PERCENT ENERGY setting. Selecting a specific pulsewidth takes the Thymatron® System IV out of any preset program. To select a specific stimulus pulsewidth:

FLEXDIAL™
P-WIDTH
0.25, 0.5, 0.75, 1.0, 1.25, 1.5 ms Because stimulus duration is limited to a maximum of 8 seconds, the higher PERCENT ENERGY settings will not be available when manually setting the 0.25 ms pulsewidth, which will provide stimuli only up to the 50% ENERGY. However, when the LOW 0.25 program is in effect, stimuli 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 increased to 100% and the patient re-stimulated within 30-60 seconds to maximize the likelihood of obtaining a therapeutically satisfactory seizure at the first treatment session.

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Before the next treatment day, the patient’s history and records should be reviewed to ensure that dehydration or ingestion of sedative-hypnotic or anticonvulsant medications have not contributed to the difficulty in obtaining a good seizure. Consideration should be given at the next treatment session to administering a stimulus dose at the patient’s age or at maximum charge. STIMULUS DOSE FOR UNILATERAL ECT Satisfactory therapeutic results can be obtained with right unilateral ECT by simply setting the PERCENT ENERGY dial to approximate the patient’s age in years (e.g., 75% for a 72 year-old patient). If a satisfactory seizure is not obtained to the initial stimulus with right unilateral ECT, proceed as described in the paragraphs 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. This is because minimum stimulus dosing has been associated with inadequate therapeutic efficacy for right unilateral ECT. STIMULUS TITRATION PROCEDURE For those who prefer to set the initial stimulus dose relative to the seizure threshold, a simple and practical stimulus titration schedule for unilateral ECT starts with an initial setting of 5% ENERGY, followed by re-stimulations at 5% ENERGY increments until a seizure occurs, to a maximum of 4 stimulations in a treatment session (on average, fewer than three stimuli are required). Once the seizure threshold is determined for a specific PERCENT ENERGY setting, the recommended dosing level for unilateral ECT is 4-6 times that threshold value (e.g., 60% to 90% ENERGY for a threshold value of 15% ENERGY). Because seizure thresholds for bitemporal and bifrontal ECT are higher than those for right unilateral ECT, the initial dose for stimulus titration with bitemporal ECT should be 10% Energy, with 5% ENERGY increments as described above. The subsequent treatments should be administered 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 has been reported to correlate with treatment response (the "target measurement"). Possible target measurements include Postictal Suppression Index (PSI), Maximum Sustained Power (MSP), or peak heart rate (PEAK HR).

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