Spectnun Specifications

All specifications are nominal and subject to change without notice .

ECT FEATURES
Pulse Configuration Constant current, bi-directional, square pulses
Internal Tests Treatment pulses into internal 30OU load and
checked for pulse width, frequency, duration
and energy. Safety features are also self-tested .
Energy Measure Delivered energy is measured, based on actual
current and voltage delivered in each pulse, so
as to be inherently correct for entire range of
dynamic patient impedance .
Patient Impedance Range (to start) 100-5000 ohms nominally.
Allowed Voltage Range for proper ECT delivery 50-400 volts .
Protection Protected against paddle-to-paddle or other
short-circuit conditions, and open circuit
conditions.
Visual Indicator Three-color LED gives green for Stimulus
Control enabled; yellow for Treating ; red for
Stimulus Delivery fault.
Audible Indicator Tones provided for pre-treatment and treatment
warnings .

LCD DISPLAY SPECIFICATIONS

Type Blue and white FSTN with cold-cathode
backlight
Dimensions 3.4 x 4.6" (5 .7" diagonal)
Resolution 240 (v) x 320 (h) pixels
Contrast adjustment via buttons LIGHT/DARK
Display sweep speed 25mm/second

POWER REQUIREMENTS
115 volts nominally, 50/60 Hz @ .25 A Typical (idle) to 2.7 A max (treat), or
230 volts nominally, 50/60 Hz @ .13 A Typical (idle) to 1 .4 A max (treat)

4000 DIMENSIONS 5000 DIMENSIONS

Weight 26.5 pounds / 12.0 Kg Weight 37 pounds / 16 .8 Kg
Height 6.9 inches / 17 .5 cm Height 6.9 inches / 17 .5 cm
Width 11 .8 inches / 30.0 cm Width 20.4 inches / 57 .8 cm
Depth 21 .4 inches / 54 .4 cm Depth 21 .4 inches / 54 .4 cm

ENVIRONMENTAL AND REGULATORY SPECIFICATIONS

All devices are Class I, continuous-operation devices. The Stimulus circuits are Type BF; the
Patient Monitoring circuits are Type BF defibrillation-protected . The fuses are 5 X 20mm time lag
(slo-blo) fuses. 4 amp (T4.OA) for 115VAC and 2 amp (T2.OA) for 230VAC . Users should choose
cUL-approved fuses for United States and Canada, and IEC-rated fuses everywhere else .

98
 OPERATING CONDITIONS
Temperature, operating 41 to 95° F / 5 to 35° C
Relative humidity, operating 30 to 70%, non-condensing

STORAGE AND TRANSPORTATION CONDITIONS

Temperature -4 to 140° F / -20 to 60° C
Humidity 10 to 95%, non-condensing
Pressure 220 to 1052 HPa
CHART RECORDER paper roll Removed

REGULATORY QUALIFICATIONS
The sPECTRuM 5000 series of products comply with the standards listed when connected to an
external personal computer (as verified during EMC testing). If connected to other devices, it is
the user's responsibility to confirm that the device still complies with the listed standards .
UL Classified
cUL Classified
Designed and tested to:
UL 2601-1, 2 Dec 1994
CE Certification '
Designed and tested to:
IEC 601-1, Medical Electrical Equipment, general requirements for safety, 1988
IEC 601-1, Amendment 1, 1991
IEC 601-1, Amendment 2, 1995
IEC 601-2-14, Medical Electrical Equipment, Specifications for electroconvulsive therapy
equipment, 1989
IEC 601-1-2, Medical Electrical Equipment. Electromagnetic compatibility, 1994
IEC 601-2-25, Medical Electrical Equipment. Particular Requirements for the Safety of
Electrocardiographs, 1993
IEC 601-2-26, Medical Electrical Equipment. Particular Requirements for the Safety of
Electroencephalographs, 1994
Accessory equipment connected to the analog and digital interfaces must be certified according
to the respective IEC standards (I .E . IEC 950 for data processing equipment, and IEC 601-1 for
medical equipment). Furthermore, all configurations shall comply with the system standard IEC
601-1-1 . Everyone who connects additional equipment to the signal input or output ports config-
ures a medical system, and is therefore responsible that the system complies with the require-
ments of the system standard, IEC 601-1-1 . If in doubt, contact the technical service department,
or your local representative .

ECT PARAMETERS
New Ultrabrief
Q models Models Four Parameter Sets : Set 1 Set2 Set 3 Set 4
Stimulus Current in 100n-LA increments 500-800 mA 500-800 mA 500-800 mA 500-800 mA
Frequency in 10-Hz steps 20-90 Hz 20-60 Hz 20-60 Hz 20-120 Hz
Pulse Width in .10 msec steps 0.5-1 .0 msec 0.5-2 .0 msec 0.5-1 .0 msec 0.3-0.37 msec
Stimulus Duration in .25- .5 steps 0 .5-4 .0 sec 0.5-3 .0 sec 0.5-6.0 sec 0.5-8.0 sec
Charge 5 .0-576 mC 5.0-576 mC 5.0-576 mC 3.0-568.3 mC
Energy Q 220 ohm patient impedance 0.6-101 .4 joules 0.6-101 .4 joules 0.6-101 .4 joules 0.3-100.0 joules
New Ultrabrief
M models M Models Four Parameter Sets : _Set 1 Set 2 Set 3 Set 4
Stimulus Current 800 mA 800 mA 800 mA 800 mA
Frequency 20-90 Hz 20-120 Hz 20-60 Hz 20-120 Hz
Pulse Width 1.0 msec 1.0 msec 1.0 msec 0.3-0 .38 msec
Stimulus Duration 0 .18-4.0 sec 0.18-3.0 sec 0.18-6.0 sec 0.5-8 .0 sec
Charge in 100 settings 5 .8-576 mC 5.8-576 mC 5.8-576 mC 5.8-576 mC
Energy © 220 ohm patient impedance 1.0-101 .4 joules 1.0-101 .4 joules 1 .0-101 .4 joules 1.0-101 .4 joules

99
 MONITORING SPECIFICATIONS
EEG/ECG/OMS PATIENT INPUTS (5000 models only)
Maximum Number of Channels 6
EEG Trace Restoration Automatic rapid return to display
EEG Lead-Off Detection Current = 30 nA DC
EEG Lead-Off Indication Trace disappears, Restore button provided when
any selected/ displayed EEG channel is
unhooked
EEG Channel Gain 5000 x from optional analog output (+/- 10%)
EEG Input Range, AC 2mV p-p max .
EEG Input Range, DC +/- 200mV
EEG Frequency Response 1 .4 to 48 Hz band pass (-3dB)
EEG Common Mode Rejection For 10V RMS, 50/60 Hz input having 200 pF
source capacitance, feeding unbalanced 51K/
.047 uF input network, resultant signal will be
< 1 mV p-p R.T.I. with notch filter off, and
< .1 mV p-p R.T.I . with notch filter on.
EEG Noise <_ 15mV p-p R.T.I . with notch filter on .
EEG Display/CHART RECORDER Gain (see chart on next page)
EEG Input Impedance > 2.5 MS2 single-ended Q 10 Hz.
EEG Protection Against ECT Pulses Provided (requires patient monitor cables w/ 1k
series resistors)

ECG Trace Restoration Automatic rapid return to display

ECG Lead-Off Detection Current = 30 nA DC
ECG Lead-Off Indication Trace disappears, Restore button provided when
any selected/displayed ECG channel is
unhooked
ECG Channel Gain 1000 x from optional analog output, +/- 10%
ECG Input Range, AC 10mV p-p max.
ECG Input Range, DC +/- 300mV
ECG Frequency Response 0.5 to 48 Hz band pass (-3dB)
ECG Common Mode Rejection For 10V RMS, 50/60 Hz input having 200 pF
source capacitance, feeding unbalanced 51K/
.047 uF input network, resultant signal will be
_< 1 mV p-p R.T.I. with notch filter off, and <_ 0.1
mV p-p R.T.I . with notch filter on .
ECG Noise <_ 30mV p-p R.T.I . with notch filter on.
ECG LCD/CHART RECORDER Gain (see chart on next page)
ECG Input Impedance >2.5 MS2 single-ended Q 10 Hz .
ECG Protection Against Defib and ECT Pulses Provided (requires patient monitor cables w/ 1K
series resistors)

OMS Technique Photoplethysmography

OMS Frequency Response 0.5 to 6.0 Hz (-3 dB) typical
OMS Trace Restoration Automatic rapid return to display
OMS No-sensor Detection Trace disappears, Restore button provided when
OMS is selected/ displayed and disconnected

DUAL CHANNEL RECORDER SPECIFICATIONS (5000 models onlv)

Chart Speed 25 mm/sec
Waveform zone width 48 ram max
Overall paper width 50 mm
Resolution 8 dots/mm vertical x 32 dots/mm horizontal
Printing method Thermal

100
 EEG SCREEN GAIN SETTINGS (mV/mm)

Tr. LOW MLOW MED MHIGH HIGH

1. .0357 .0178 .0071 .0036 .0014

U
cV
2. .0732 .0366 .0146 .0073 .0029 .
b
3. .1113 .0557 .0223 .0111 .0045 .
.
A 4. .1504 .0752 .0301 .0150 .0060,

ECG SCREEN GAIN SETTINGS (mV/mm)

Tr. LOW MLOW MED MHIGH HIGH

1. .1784 .0713 .0357 .0178 .0089,

U
cd
2. .3661 .1465 .0732 .0366 .0183,
H
b
3. .5565 .2226 .1113 .0557 .0278
.
A 4. .7521 .3008 .1504 .0752 .0376 .

* "Displayed traces" means the total number of traces on the LCD screen,
including EEG, ECG and OMS .

EEG CHART GAIN SETTINGS (mV/mm)

Tr. LOW MLOW IVIED MHIGH HIGH

U

h
b 1. .050 .025 .010 .005 .002 '

w
a 2. .100 .050 .020 .010 .004
A

ECG CHART GAIN SETTINGS (mV/mm)

Tr. LOW MLOW IVIED MHIGH HIGH

U

1. .250 .100 .050 .025 .010

b

2. .500 .200 .100 .050 .020

CIO

A
** "Displayed traces" means the total number of traces on the Chart
Recorder printout, including EEG, ECG and/or OMS.
i
ii

vr
See also the section on Error Messages in this manual for additional input on identifying and
clearing problems . Machines will need servicing mainly for errors that users cannot clear by
themselves . These will appear as numbered errors, and the user will need to consult the factory
for assistance.

Problem Description Possible Problem or Solution

sPECTRuNt does not operate . No line voltage connected and/or fuse

may be blown . Verify that:
a. Fuses are OK,
b. Power switch is ON,
c. Unit is plugged into a proper outlet,
and cord is fully seated in power
entry module .
d. Outlet works for other equipment .
e. Power entry module is set for correct
line voltage .

CHART RECORDER does not Make sure Chart Recorder is turned on

operate at all . in the CHART OPTIONS MENU, paper is
properly loaded, recording module is fully
seated, and its door is fully closed .

STIMULUS CONTROL does not STIMULUS CONTROL push button is disabled if

work when the STIMULUS hand-held electrodes are connected to the
STATUS INDICATOR is Green. STIMULUS OUTPUT connector.

Static impedance indicates OVER, Scalp electrodes have insufficient contact area, or
or gets PATIENT IMPEDANCE insufficient electrode gel, or are not connected to
INCORRECT message. the patient, or cable is broken .

RESTORE button appears. a. Insure all selected leads are displaying traces .
b. De-select disconnected leads in the
LCD and CHART TRACE MENUS.
c. Lead connections to cables are
scrambled or defective .
d. A non-snECTitvtvi type cable is used.
e. Cable is plugged into wrong connector.
f. A very old electrode is being used .
g. OMS is unplugged, or defective.

102
Problem Description Possible Problem or Solution

Paper prints from CHART Check to see that paper roll is so inserted that
RECORDER, but no printout is paper feeds off underside of the roll, and is laid
produced. over the top of the recorder door. Thermal paper
will print only on one side. Scraping thermal
paper rapidly with a finger nail should leave a
black mark.

LCD is too dark/too light. Use the contrast control buttons on the COPY-
RIGHT and MAIN MENU displays to lighten or
darken the display.

LCD or CHART RECORDER trace Check the appropriate lead for good connections
data is not displaying . from the sPECTRuM to the patient.

Touch Screen buttons do not work. If the unit has Membrane Switches to the left of
the LCD, use those instead .
(there is no touch screen) .

- -

103
 These maps depict the routine display sequences on the SPECTRUM Q-model .

Pre-Treatment Displays Map M-model displays will show different parameter configurations .
Error message displays and most variations are not shown.

L21B CE

31/13/97 SPECTRUM 50000°

SPECTRUM 50000" LIGHT
1O :OO:QO CLEARi LIGHT
MECTA COFIPORArION : MECTA COt7PORArION :
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . .
® COPYRIGHT 1997 . . . . . .: . . . . . . . . . : . . . . . . . . . ----~. . . . . . . . . : . . . . . ® 60PYRIGHT 1997 . . . . . . : . . . . . . . .
ALL RIGHTS RESERVED ~ ALL RIGHTS RESERVED
I I
. . . ..:. . . ... . ..: . . .. .... .: . ...... . .:. . ...... . .: . ........ . . . .. .... : . . .. ... . .: . .. .....
INTERNAL TEST PASSED :
PERFORMING : AD:lUST CONTRAST
.i . . . . . . . . ., . .INTEFtNAL . .;. . . . . . . . . : . . . . . . . . . . . . . . . . . ;. . . . . . . . .
PRESS:CLEAFi TO PROCEED
TESTS ~

11/13/87 11/13/97
10:OO :UO : 10:OO:DO. . . . . . : . . . . . . . . . : . . . . . . . . . ;. . . . . . . . . .. . . . . . . . . . . ;. . . . . . . . .

CENTRAL PROCESSOR REVISION V1i1 .8.CEQA60P CENTRAL PROCESSOR REVISION V7;.1 .8.CEQ60AP
DARK
SAFETY PROCESSOR REVISION V7:1 .6

.miomro-------------------------1
soM

TIMER
10:00:00
. MENU 10:OO:0o
TIMER MENU

ECG ;
.#1
. . ._ . . . . . . . ._ . . . . . ., . . . ., . . ._ . . . . . ._ . . . . . . . . . . . . . . . . . . . . . . . . . . . PRESS STIMULUS BUTTON
` FORTREATMENT ~
EEG
.

- : oMS : I _. . . _ _
1880
ohms I
K
300 : _ < _ ._ . _ _ .. .
50 mc : . 0.6J. 0 .220 ohms
ohms : l ~
0.5 msec 20 Hz ; 0.500 sec : 500 mA
. . . . . . . . . :. . . . . . . . . : . . . . . . . : . ~. . . . . . . . . . ; . . . . . . . . : . . . . . . . . .
5.0 mC 0.6 J: 0 220 ohms
0.5 msec . 20 Hz 0.500 sec : 500 m71

5000 models 4000 models

--------------------------
sosa,o,aaro
11/13/97
10 :00 :00

To Treatment
: . .. .L . .. . ._ . : . ..._ . .STIMULU$-ABOUTTO OCCl1R: :i. . ... . . . . .. . .. .
displays

. ... . .: . ... .. . . .. . ... .:. .._ ... .._.. . ;.... . . ... ... ..:. .. . ... ... ... . .: . ... .. . .. . ... .:. . .. . ... . .. .. .

... . ..... . ... . .. ; ... ... . ... . . . . .. .. . . .. .... ......

.0 ;mC .0.6 4 .0 .220 ohms
Q ( 0.5 sec ', 20: Hz 0:500 soc 500 MA
 ---,
/
Treatment /
r
& Post-Treatment /
1
EEG DATA /
1

Displays Map
1 ~ ~---~-STiM .AbEO: 25%i1KELY--~ °°~ 1
EST. STIM. LVL. :2 2T (42%) 1
/
1
/
1
1
1
1
/
300 1
/
ohms : ' 1
/
. . . ._ . . . . . .. . .., . .. . .. . .. . . . . . .. . .. . .__ . . .. . .: ._ . . .. . .. . .._ .; .._ .. . ._ .. . . .. . . . ELAPSED TIME
. .. . . . . .. . . . ;..._ . . .._. . .. ; . . . . ..0:01
. . . . .. . . . 1
/
5.0 :mc 0 .6'J 0 : 2200hms /
/
0 .5 msec 20 14z 0 .5001sec 500 tRA /
/
/
/ 1
/ 1
L
1
/ TREATMENT RESULTS
- - .1
/
. . . . . . . : . . . . . . . . . : . .STATIC . . . . . . . .:4YNAMIC . . . . . . .: . . . . . . . .
1 0:00
CHARGE 5 : 5 mC TRACEI ' . ITIMERI 10~01 I MENU
/ ENERGY : 0 .6 : J :
0 .60220
/ IMPEDANCE. :. . . . .300 :. . . . . . . . . .: . .245. . . :. . . . . .ohms . . . . . . TREATMENT RESULTS
1 PULSE WIDTH 0 .5 : ~ 0 .5 - msec
.
.~'. .STATIC _ . . .~'.DYNAMIC. . .
/ FREQUENCY : 20 ~ : 20 Hz : CHARGE ~ ~. 192~ ~I 192 -. mC
DURATION . : .0,500 0,500 :~ sec .
From Pre-Treat
! ENERGY ~ 33.80220 ! 24.6 ~I 1 '.
/
300 : I CURRENT 500 : ~ 500 ~ MA IMPEDANCE ~' 640 ~ - . . . ~ ! 180 -' . . ohms . . ~
1
displays ohms : '. PULSE WIDTH 1 .0 '. '. 1 .0 '- ms6c
FREQUENCY 60 60 H.
/
. . . . . . . . . ; . . . . . . . . ; . . . . . . . . . : . . . . . . . . . :. . . . . . . . . . :ELAPSED
. . . . . . . . .;. . .TIME
. . . . . .. . .0:01
.... . . . - DURATION -I. 2.000 2.000. ~I . . sx . . . .
/ 5.0 :mC 0 .6J ® 220 ohms 640 i CURRENT .~ 800~. ~. 800 ' mA
ohms l
1 :ELAPSEDTIME 0:01 .
0.5 rrisec 20 Hz 0 .500 sec 500 mA
1 / 192 .0 mC' - 33.8 J 0 ' 220 ohms

1 1 .0 mcee . 60 Hz .- 2 .000 sea . 800 mA

1
1
(If EEG monitoring menu option is set to
/ /
/ / OFF, then only this display appears .
/ No EEG data screen is then available .)
To Pre-Treat
/ /
/ / displays
To Pre-Treat
/
displays ~8c 1]6b0011E ---------- '

:00 [
t
r
DONE TIMERI '0 :~ C MENU

lGbtl~OOI/M

11/13197 REATMENT RESULTS

10 :00 :00

------------- CHARGE 5 ; 5 me
ENERGY : 0.60220 ~ 0 .6 ; J :
I #1,... . .I~Y.~.~~:::T ..T..~.-.y....p i..y... . .y._ .y ... p. . :.v IMPEDANCE,9.. . ... .300 . . .. . . .. . .. . . . .i . .306 . . . .i .. . . .. . .ohms . .. . . .. . . .
PULSE WIDTH 0.5 : 0 .5 : msec

DELIVERING STIMULUS
10-1 300 :
.,OMS
. .. . . . . . .. . . .. .,..; . .. . . . . . . . . . .; . ... . . . .. . . .. ;. . . .. . . ..- --
300
FREQUENCY` 20 :
DURATION
CURRENT ~
. .. . .i. . .. . . .0.500
500 ;
. . . .. . .. . . .;
: 20
. . .OS00
~: 600 :
.
:
:. . . . . . . .
Hz :
.sed . . .. . ... . ... . ..
MA
L~ ohms : ohms
;... . .. . . .. . .. . . ,. . . . . . . .. .. . . . ; . .. . ELAPSEDTIME , .. . . . . . . . . . : . 0.. :01
. .. . . .. . :ELAPSED TIME .O".01 . .. .
Activates further 5 .0 Ii1C 0.6: J 0 ; 220 ahms 5 .0 :mC : 0 .6'J ! : 220 ohms
treatments 0 .5 Risec 20 Hz ' 0 .500sec 500 iRA 0 .5 msec 20 Hz 0.500 sec ? 500 mA

5.0 mc 0.6 J 0 220 ohms 5000 models 4000 models

0.5 msec 20 Hz 0.500 sec 500 mA
L---------------------------
 50 vATIENi MEIVV I Iy
On 4000 models with Touch Screens, the Date and Time
PATIENT DATA MENU and Parameter Selection menus are the only display
Menu Displays M p
ii
EXIT
. . . ... . . ... . . . ... . . . options available .
so oaT V~G
PATIENT 3
ID 123456789 DATE AND TIME MENU
EXIT
; . . . . . . . . . .. . . . . . . . . . :. ., . . . . . . .
All sub-menus EXIT to the main menu, PATIE T
4 © 0
AGE AGE N
which then EXITS to whatever display 30

accessed the menu system . . . . .. . ... . ... ..: . . .

®
NUM
TREATMENT
:
NUMBER
0 0 11/13197
. 1 7
MM/DD/YY 4 5 0
. . . . . . . .. . . ... . ...
MAINTENANCE 0 <
YES
TREATMENT : TIME 7 I 8 9
, ... . . ... . F
ELECTRODE
UL f BL
PLACEMENT

_ . :_ . . . . . . . ._, .___ . . . . . . . . . . . . . . ... .

EEG #1 Select trace (left) MENU Sa 2 .6I C
then channel (below)
. . ._ ; . . . . ._ . . : . ., . . . . . . ;. ._ . . . . . .~ ._____.' . ... . . ...

EEG #2 Opalnmwu ~G

PuRi SSTUP MEHU.e i 1-

CHART TRACE MENU

EXIT

CHARTTRACES : , ` ©

EEG #1 ~ Select tFace (left)

® UPPER TRACE then choknnel (below)
;... . . . ..:
TRACE EEG #2 : E#1CG
OMS
#2 LOWER TRACE
; . . ... . . . .:... . . . ...:. . . .... . .
I EEG 50 OCTIOUS

® #2 CHART OPTIONS MENU

EXIT

CHART ON/OFF: ON OFF

50 VAFM9 0 200JIA

EEG DATA MENU : PARAMETER SELECTION MENU

EXIT PRINT PATIENT DATA? YES

MAXIMUM PARAMETER SETTINGS

EEG DATA : : ON OFF PW FREQ DUR CUR

# CHANNELS: ©

USE . EEG1 . FDFt LEFT FRONTAL/MASTGIp . . . . . . . . : . . . . . . . . . On 4000 models with Membrane Switches, the
USE EEG2 FOR RIGHT FRONTAL/MASTOID Parameter Selection menu is the only menu
available .
 : MECTA Corporation
19799 SM. 95th Avenue, Suite B, -Bldg. D, Tualatin, OR 97062
b
b
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v
~c
Additional Monitoring Channels 8/5/09 5:10 PM

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",

i .'~.I~`~ :,_I 1~~~I `.~.-~,`S'If ~.

Home » Products » ~Ni»,C;l ruhi GLJiCES s> Options » Additional MonitorinG vin-

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Options D01V1 refers to U .S ./Canada
IWT refers to all other countries
~ Hand-Held Electrodes

~ Additional Monitoring Channels

Additional Monitoring C.1-Lannels
;, Optical Motion Sensor h 5000 model spECTrum purchase includes the choice of two
monitoring channels : EEG 1 and EEG 2, or EEG 1 and an ECG
ie EEG Data Analysis channel (electrocardiogram) . However, for clinicians who wish
redundancy or have specific research requirements, up to four
Remote Monitor Softwarea- additional monitoring channels may be added to an EEG/ECG base
model . Three channels of EEG and one Optical Motion Sensor for
~ IIiIECTA RMS MAP3AGER~ monitoring motor activity complete the six channels of monitoring
available on the spECTrum 5000 series, providing maximum
p- MECTA EMRO'
monitoring capabilities for all ECT treatment requirements . An
Sturdy Hospital Cart EEG/EEG/ECG option with or without Optical Motion Sensor is also
available .
~ spECTrum Devices Click to enlarge
~ Clinical Accessories
i For those who wish to view or database the
! real-time trace data, add Remote Monitor
, Softwarea and MECTA RMS MANAGER©, or
I MECTA EMRa.
Contact Us

Request for f}tiotatiort

ck to enlarge
Request tor Sf_~fVice ()c1ute
I time, simultaneous monitoring of up to eight channels : 4 EEG,
and 1 Optical Motion Sensor and duplicate EEG traces .

i-,)~_r ~ .iser-select~.d cli ;inneis o( reai-hrne nir~nit(~Ii~i~~ c~ri tii~,

;D!' .I"c,uCh :-CrE'n .

(} u ;A :r_sF_i,_~cted channels on the ~~I-, t Reccr~J~~r

,- .ihurced s ~vF-fonn a~.~alit,~ h, chgi,~31 sicn~l I c"~~iny, (DSfai .

:rhlCh :Fllter t,(fld`dcirlteCl fllltlff-r'.41C'~L' fUf reGt,IGed ,, I`tl

..  ._ . . . . ._ . ._,. ., .__ .... .

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MECTA MANUALS AND TITRATION TABLES

MECTA Corporation does not Titration Tables spECTrum Instruction Manual

provide medical advice, nor do we
sell our products to anyone but
licensed clinicians and hospitals .
Please contact your local mental
health provider, Veteran's hospital,
or University hospital for information spECTrurn Service Manual , Remote Monitor Software Manual
about electroconvulsive therapy
{ECT} . Contact 911 in case of a
mental health emergency .

RIMS MANAGER Software Manual spECTrum Instruction Manual -

International Version
Coritact !J s

ftett>lfFst for Cclvtation spECTrum Service Manual -

International Version

Request for Service Quote

CLINICAL PUBLICATIONS

The Practice of Electroconvulsive practica de la terapia

Therapy-A Taskforce Report of the electroconvulsive - APA Taskforce
APA Report - Spanish

ECT: A Programmed Text

PATIENT AND FAMILY BOOKS, VIDEOTAPES AND DVDS

Electroconvulsive Therapy (Patients Shock - The Healing Power of

and Families DVD - Dartmouth Electroconvulsive Therapy by Kitty
Hitchcock University ; ` Dukakis and Larry Tye

Undercurrents - A Life Beneath the Shock DVD -A documentary

Surface by Martha Manning produced by AMS Production Group,
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Selected Citations in ECT Literature

1 . Meduna, L .J . : The convulsive therapy of schizophrenia . Psychiatr Neurol Wochenschr, 1935, 37 :317-319 .

2 . Kalinowsky, L .B ., and Hoch, P .H . : Shock Treatments and Other Somatic Procedures in Psychiatry, New
York: Grune & Stratton, 1946 .

3 . American Psychiatric Association Task Force on ECT : Electroconvulsive Therapy, Task Force Report #94 .
Washington, D .C . : American Psychiatric Association, 1978 .

4. Blachiey, P ., Denny, D ., Fling, J ., Nioulton, C . : A new stimulus generator and recorder for e6ectroconvuisive
therapy, Unpublished Manuscript, 1974 .

5 . Fink, LVI . : Convulsive Therapy: Theory and Ara New York : Raven Press, 1979 .

6 . Weiner, P..D . : ECT and seizure threshold : Effects of s lus waveform and electrode placement. Biological
Psychiatry, 1980 ; 15 :225-241 .

7 . Crowe, R. : Current concepts. Electroconvulsive therapy--a current perspective . New England Journal of
Medicine, 1984, 311 :163-167 .

8 . Weiner, R .D . : Does CCT cause brain damage? Behavioral Brain Science, 1984, 7 :1-53 .

9 . tdlaiitz, S ., Sackeim, H .A . (Eds) : Electroconvulsive Therapy.- Clinical and Basic Research Issues . New York
Academy of Sciences, New York, 1986 .

10 . Weiner, R .D ., r-togers, I-1 .J ., Davidson, J .R ., et al : Effects of stimulus parameters on cognitive side effects .

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Ann N Y Academy of Sciences, New York, 1986, 462 :315-325 .

11 . Sackeim . H .A ., Decina, P ., Kanzier, M ., Kerr, B ., and Malitz, S . : Effects of electrode placement on the
efficacy of titrated, low-dose ECT. American Journal of Psychiatry, 1987, 144 :1449-1455 .

12 . Sackeim, H .A ., Decina, P ., Portnoy ; S ., Neeley, P., and Maiitz, S . : Studies of dosage, seizure threshold, and
seizure duration in ECT . Biological Psychiatry, 1987 . 22 :249-268 .

13 . Sackeim, H .A ., Decina, P ., Prohovnik, I ., and Malitz, S . : Seizure threshold in ECT : Effects of sex, age,
electrode placement and number of treatments . Archives of General Psychiatry, 1987, 44 :355-360 .

14 . Weiner, R .D ., Coffey GE . : Indications for use of electroconvulsive therapy, in Review of Psychiatry, Vol 7 .
Edited by Frances, A .J ., Hales, R .E . Washington, DC, American Psychiatric Press, 1988, 458-481 .

15 . Prudic, J ., Sackeim, H .A., and Devanand, D .P . : Medication resistance and clinical response to
electroconvulsive therapy . Psychiatry Research . 1990, 31 :287-296 .

16 . American Psychiatric Association : The Practice of ECT: Recommendations for Treatment, training and
Privileging . First Edition . Washington ; D .C . : American Psychiatric Press, 1990 .

17 . Devanand, D .P ., Verma, A .K ., Tirumalasetti, F., and Sackeim, H .A. : Absence of cognitive impairment after
more than 100 lifetime ECT treatments . American Journal of Psychiatry, 1991, 14£i : 929-932 .

18 . Nobler, M .S ., Sackeirn, H .A ., Solomou, M ., Luber, B ., Devanand, D .P ., and Prudic, J . : EEG manifestations

during ECT : Effects of electrode placement and stimulus intensity . Biological Psychiatry, 1993, 34 :321-

19 . Sackeim, H .A ., Prudic, J ., Devanand, D .P ., Kiersky, ,1 .E ., Fitzsimons, L ., Moody, B .J ., i`JIcEittiney, tv1 .C .,

Coleman, E .A., and Settembrino, J .M . : Effects of stimulus intensity and electrode placement on the efficacy and
cognitive effects of eiectroconvulsive therapy . New England Journal of Medicine, 1993, 328 :839-846 .

20 . Zielinski, R .J ., Roose, S .P ., Devanand, D .P ., t~lloodring, S ., and Sackeim, H .A . : Cardiovascular

complications of ECT in depressed patients with cardiac disease . American Journal of Psychiatry, 1993,
150 :904-909.

21 . Krystal, A .D ., Weiner, R .D ., McCall, W .V ., Shelp, F ., Arias, R ., and Smith, P . : The effects of ECT stimulus
dose and electrode placement on the lots] electroencephalogram : An intraindividual placement on the ictal
electroencephalogram : An intraindividual cross-over study . Biological Psychiatry, 1993, 34 :759-767 .

22 . Devanand, D .P ., Dwork, A .J . . Hutchinson, E .R., Bolwig, T .G ., and Sackeim, H .A . : Does electroconvulsive

therapy alter brain structure? American Journal of Psychiatry, 1994, 151 :957-970.

23 . Mukherjee, S ., Sackeim, H .A ., and Schnur, D .B . : Electroconvulsive therapy of acute manic episodes : A

review of 50 years of experience . American Journal of Psychiatry, 1994, 151 :169-176 .

24 . Nobler, M .S ., Sackeim, H .A ., Prohovnik, I ., Moeller, J .R ., Mukherjee, S ., Schnur, D .B ., Prudic, J ., and

Devanand, D.P . : Regional cerebral blood flow in mood disorders : II( . Effects of treatment and clinical response
in depression and mania . Archives of General Psychiatry, 1994, 51 :884-897 .

25 . Sackeim, i-I .A., Long, J ., Luber, B ., Moeller, J .R ., Prohovnik, L, Devanand, D .P ., and Nobler, M .S . : Physical
properties and quantification of the ECT stimulus : I . Basic principles . Convulsive Therapy, 1994, 10 :93-123 .

26 . Sobin, C., Sackeim, H .A ., Prudic, J ., Devanand, D .P ., Moody; B .J ., and McElhiney, M .C . : Predictors of

retrograde amnesia following eiectroconvulsive therapy . American Journal of Psychiatry, 1995, 152 :995-1001 .

27 . Krystal, A.D ., Weiner, R .D ., Coffey, C .E . : The ictal EEG as a marker of adequate stimulus intensity with
unilateral ECT . J. Iti.'europsychiatry and Clinical Neurosciences, 1995, 7 :295-303 .

28 . Prudic, J ., Haskett, R .F ., Mulsant, B ., Malone, K .M ., Pettinati, H .M ., Stephens, S . . Greenberg, R ., Rifas,

S .L ., Sackeim, H .A. : Resistance to antidepressant medications and short-term clinical response to ECT .
American Journal of Psychiatry, 1996, 153 :985-992 .

29 . Krystal, A.D ., Weiner, R .D., Coffey, C .E ., McCall, W.V. : The effect of ECT treatment number on the ictal
EEG . Psychiatry Research, 1996, 62 :179-189 .

30 . Krystal, A .D ., Weiner, F": .D ., Gassert, D ., McCall, W.V., Coffey, C .E ., Sibert, T., Hoisinger, T . : The relative
ability of 3 ietal EEG frequency bands to differentiate ECT seizures on the basis of electrode placement,
stimulus intensity, and therapeutic response . Convulsive Therapy, 1996, 12 :13-24 .

31 . Sackeim, H .A ., Luber, L ., Katzman, G .P ., Moeller, J .R ., Prudic, J ., Devanand, D .P ., and Nobler, PJI .S . : The
effects of electroconvulsive therapy on quantitative EEG : Relationship to clinical outcome . Archives of General
Psychiatry, 1996, 53 :814-824 .

32 . CJlfson, M ., Marcus, S ., Sackeim, H .A., Thompson, J ., and Pincus, H .A. : Use of ECT for the inpatient
treatment of recurrent major depression . American Journal of Psychiatry, 1998, 155 :22-29 .

33 . Krystal, A .D ., Cof(ey, C .E ., Weiner, R .D ., Halsinger, T . : Changes in seizure threshold over the course of
electroconvulsive therapy affect therapeutic response and are detected by ictal EEG ratings . J. Neuropsychiatry
& Clinical Neurosciences, 1998, 10 :178-186 .

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34 . Lisanby, S .H ., Maddox, J .H ., Prudic, J ., Devanand, D .P ., and Sackeim, H .A . : The effects of

electroconvulsive therapy on memory of autobiographical and public events . Archives of General Psychiatry,
2000, 57 :581-590 .

35 . McCall, W.V ., Reboussin, D .M ., Weiner, R .D., and Sackeim, H .A. : Titrated, moderately suprathreshold
versus fixed high-dose right unilateral electroconvulsive therapy : acute antidepressant and cognitive effects .
Archives of General Psychiatry, 2000, 57 :438-444 .

36 . Sackeim, H .A ., Prudic, J ., Devanand, D .P ., Nobler, M .S ., Lisanby, S .H ., Peyser, S ., Fitzsimons, L ., Moody,

B .J ., and Clark, J . : A prospective, randomized, double-blind comparison of bilateral and right unilateral ECT at
different stimulus intensities . Archives of General Psychiatry, 2000, 57 :425-437

37 . Krystal, A.D ., Holsinger, T ., Weiner, R.D ., Coffey, C .E . : Prediction of the utility of a switch from unilateral to
bilateral ECT in the elderly using treatment 2 ictal EEG indices . The Journal of EC7", 2000, 16 :327-337 .

38 . Krystal, A .D ., Weiner, R.D., Lindahl, V ., Massie, R. : The development and retrospective testing of an
electroencephalographic seizure-quality based stimulus dosing paradigm with ECT. The Journal of EC7`, 2000,
16 :338-349 .

39 . Nobler, M .S ., Oquendo, Pv9 .A ., Keyeles, L .S ., Malone, K.M ., Campbell, C ., Sackeim, H .A ., and Mann, J .J . :
Decreased regional brain metabolism following electroconvulsive therapy . American Journal of Psychiatry,
2001, 958 :305-308 .

40 . Sackeim, H .A ., Haskett, R .F ., Mulsant, B .H ., Thase, M .E ., Mann, J .J ., Pettinati, H .M ., Greenberg, R .M .,

Crowe, R .R ., Cooper, T .B., and Prudic, J . : Continuation pharmacotherapy in the prevention of relapse following
electroconvulsive therapy : A randomized, placebo-controlled trial . Journal of the American Medical Association,
2001,285 :1299-1307 .

41 . American Psychiatric Association : The Practice of ECT: Recommendations for Treatment, Training and
Privileging . Second Edition . Washington, D .C . : American Psychiatric Press, 2001 .

42 . Abrams, R . : Etectroconvulsive Therapy . New York: Oxford University Press, 2002 .

43 . Kellner, C .H ., Knapp, R .G ., Petrides, G ., Rummans, T .A ., Husain, tdl .M ., Rasmussen, K ., Mueller, M .,

Bernstein, H .J ., O'connor, K ., Smith, G ., Biggs, M ., Bailine, S .H ., Malur, C ., Yim, E ., Mcclintock, S ., Sampson,
S ., and Fink, M . : Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major
depression : a muitisite study from the Consortium for Research in Eiectroconvulsive Therapy (CORE) . Archives
of General Psychiatry, 2006, 63 :1337-1344 .

44 . Dwork, A .J ., Arango, V ., Underwood, M ., Ilievski, B ., Rosoklija, G ., Sackeim, H .A., and Lisanby, S .H . :

Absence of Histological Lesions in primate models of electroconvulsive therapy (ECT) and magnetic seizure
therapy (MST) . American Journal of Psychiatry, 2004, 961 :576-578 .

4;5 . Prudic, J ., Olfson, M ., Marcus, S .C ., Fuller, R .B ., and Sackeirn, H .A. : Effectiveness of electroconvulsive
therapy in community settings, Biological Psychiatry, 2004, 55 :30'1-312 .

46. Sackeim, H .A, : The convulsant and anticonvulsant properties of electroconvulsive therapy : towards a focal
form of brain stimulation . Clinical Neuroscience Research, 2004, 4 :39-57 .

47 . Perera, T .D ., Coplan, J .D ., Lipira, C .M ., Arif, M ., Carpio, C ., Spitzer, C ., Santarelli, L ., Scharf,

B ., Hen, R., Rosokiija, G ., Sackeim A., Dwork, A.J : Antidepressant-Induced Neurogenesis in the
Hippocampus of Adult Nonhuman mates. The Journal of Neuroscience, May 2007, 27(18) ; 4894-4901 .

48 . Sackeim, H .A., Prudic, J ., Fuller, R . . Keilp, J ., Lavori, P .W. ; and Ulfson, M . : The cognitive effects of
electroconvulsive therapy in community settings . Neuropsychophanrracology, 2007, 32 :244-254 .

49 . Sackeirn, H .A. Prudic, J ., Nobler, M .S ., Fitzsimons, R .N ., Lisanby, S .H ., Payne, N ., Berman R .M .,

Brakemeier, E .L ., Perera, T.P ., Devanand, D.P . : Effects of Pulse Width and Electrode Placement on the
Efficacy and Cognitive Effects of Electroconvulsive Therapy . Brain Stimulation, April 2008, 1 :71-83 .

50 . Spellman, T., Peterchev, A.V., Lisanby, S .H . : Focal Electrically Administered Seizure Therapy : A Novel form
of ECT Illustrates the Roles of Current Directionality, Polarity, and Electrode Configuration in Seizure Induction .
lVeuropsychopharrnacology, 2009, 34 .

51 . Sackeim, H .A., Dillingham, E .M ., Prudic, J ., Cooper, T ., McCall, W .V ., Rosenquist, P ., Isenberg, K ., Garcia,

K ., Mulsant, B .H ., Haskett, R .F . : Effect of Concomitant Pharmacotherapy on Electroconvulsive Therapy
Outcomes. Archives of General Psychiatry, 66 :(7) : 729-737, 2009.
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sell our products to anyone but Wesley Woods Geriatric Hospital, Emory University, Atlanta-GA
licensed clinicians and hospitals .
Please contact your local mental Visiting ECT Fellowship Program - Physicians and Nurses
health provider, Veteran's hospital, Physician Fellowship email : vaulx-smithpm@upmc .edu
or University hospital for information Nurse Fellowship email : wiskemancl@upmc .edu
about eiectroconvulsive therapy University of Pittsburgh School of Medicine, Pittsburgh-PA
(ECT) . Contact 911 in case of a
mental health emergency . Visiting Fellowship in ECT- Physicians and Nurses
Duke University, Durham-NC

Visiting Fellowship in ECT- Physicians and other mental health professionals

(:otrlact Us Email : BrainStimCIVIE@columbia .edu
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~ Additional Monitoring Channels

E.EG Data An alysis
~ Optical Motion Sensor The assessment of a patient's baseline and post-stimulus
electroencephalogram (EEG) provides the clinician with a visual
~ EEG Data Analysis indication of the nature, quality and duration of seizure activity . The
EEG Data Analysis feature was developed by Duke University,
Remote Monitor Softwaree patented, and exclusively licensed by MECTA for use in the
spECTrum 5000 model ECT devices . This feature provides the
t 1`JIECTA RMS MANAGEROc capability to automatically analyze EEG signals using a patented
algorithm developed over years of acquired treatment data to provide
TA EMRa
seizure adequacy information that has been demonstrated to be of
t: Sturdy Hospital Cart clinical relevance .' The Seizure Adequacy* and Stimulus Level"
measures are recorded on the chart strip and in MECTA RMS
~ spECTrum Devices MANAGERC or MECTA EMRO software .

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RecttrF, ~rt for .fviCE' ()UCY1E3
I Krystal AD . The clinical utility of ictal EEG seizure adequacy models . Psychiatic Annals .
1998 ;28 :30-35 .
2 Krystal AD MD MS, Weiner R D MD PhD: ECT seizure duration : reliability of manual and
computer-automated determinations . Convulsive Therapy 1995 ;11 :3 :158-169 .
Iw~ EEG Data Analysis data sheet
`Duke U.K. Patent #2 304 196 B - U.S . Patent #5,626,627
M DOM (Under exclusive license from Duke University)
EEG Data Analysis data sheet
INT
THE ONLY DUKE UNIVERSITY DEVELOPED AND PATENTED
ANALYSIS FEATURES . MECTA IS THE ONLY COMPANY LICENSED
TO INCLUDE THE DUKE UNIVERSITY EEG SEIZURE QUALITY
MEASURES IN ITS PRODUCTS .

EEG Data Analysis is a valuable tool to assist the clinician with an

empirically-based means to predict seizure adequacy and to
regulate stimulus dosing .

Th ;,se are trln c,nl ;i Fxistinc! EvCT indt :U ier~_lr)t,ed with c:tuai
nliri~a! stirriulus ctcsinn ~jmd ii,eatnii,nt ~E. ;>t :on ;, da ;a :>ho :an to
outco^ie .

E _C3 Data Analysis was developed by Duke University and based on

ten years of research, with results detailed in double-blind,
rancJornized, peer-reviewed scientific literature 2 .

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f;EG Data i~~n alv ;s pater ;t,-1 an ;j Il Gii Xclu.Jvefy+ to ME'CTFS,_

I? is uaJabiu a, opGon ill fJ1' :: u000C 'Lmd 51ur",P,4 i~f=-i=;-f-,till
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I Motion Sensor Hand-Held Electrodes are an efficient and economical accessory for initiating a stimulus during ECT
treatments . These third-generation electrodes have been re-designed with a single molded handle and
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Remote Monitor Softb^Jare© Four styles are available for use with a spECTrum EGT device :
MECTA RMS MANAGER*

MECTA EMROc For Unilateral Treatments - Single handle with or without a Remote
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Redefining Electroconvulsive Therapy
Please contact your local mental
health provider, Veteran's hospital, MECTA Corporation has defined the highest standard of
or University hospital for information excellence in the field of ECT neuromodulation devices
about electroconvulsive therapy through evidence-based research since its inception . A
(ECT) . Contact 911 in case of a breakthrough by Dr . Paul Blachley with MECTA ECT
mental health emergency . research in 1973 at Oregon Health Sciences University
produced the first and only, monitored (EEG/ECG), brief
pulse ECT devices - MECTA C and D. Subsequent
Sign up to become .1 research at Columbia University was implemented into the
I`AECTA Service Subscfiber third generation MECTA SR and JR digital devices which
were introduced in 1985, and they utilized the first RUL
ECT, multiple dosing schemes and titration . 4e
Sign i.lfr 14) expeciRe
In 1998 controlled research from Duke University and
Clinical Accessories ~'trtiers
Columbia University was integrated into the current
MECTA spECTrum 5000'&` and 4000 devices, the first and only EEG Data Analysis- feature, 3s and the
spECTrum ULTRABRIEF@ 0.3 ECT 49 which dramatically minimizes cognitive effects . These advances
Contact US continue to lead the field .

MECTA ECT has advanced the highest standard of excellence for over thirty-five years . ECT continues to be
the only neuromodulation modality providing up to an 80°lo response rate. 41 We are proud that MECTA's
ftecplest fur outotation innovative device designs, which have been utilized worldwide in peer reviewed, randomized, double-blind
studies, have resulted in optimized patient outcomes through four generations of ECT devices .

Request for Service t)ttttte Design All MECTA devices include extensive redundant hardware
and software testing to verify that they are operating correctly . The
safety of these devices is unparalleled, and as such these devices
are an advance that will impact the safety and effectiveness of
the ECT treatment.
" U .S . Patent #5,755,744 - U .S . Patent #6,014,587 - U .K . Patent
#GB 2 307 413 B
** Duke U .K . Patent #2 304 196 B - U .S . Patent #5,626,627

Quality and Safety Standards MECTA's manufacturing and

service operations are regulated under the international ISO 9001
Quality Standard so that MECTA customers can be assured of
product safety and quality . MECTA has extensive regulatory
agency approvals worldwide : U .S . (UL) ; Canada (CSA (cUL),
Health Canada-8 Approvals, #1537, #62578, #62576) ; European
Union, TUV (EN ISO 13485 :2003+AC 2007 ; CMDCAS ISO
13485 :2003, EC 93142/EEC Annex II, Article 3) ; Korea (KFDA) ;
Australia (TGA) .

Environment MECTA has always recognized the need to be

responsible stewards of the environment. Reduction of
manufacturing waste and emissions, responsible operations
resources management, and no-charge device recycling, are all
integral parts of MECTA's environmental policy . We are
voluntarily committed to achieving 100°lo RoHS (lead-free)
compliance .

Quality Policy It is the policy of MECTA to design, fabricate,

market, distribute, and service its ECT equipment with consistently
high quality so that MECTA will continue in its position of
leadership in the industry. All of our products will meet all

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MECTA Corporation - Electroconvulsive Therapy (ECT) 8/6/09 1:47 PIv1

applicable laws and regulations . MECTA's emphasis on quality

involves all personnel . Our goal is satisfied customers . MECTA
continually improves its Quality Management System to meet
these objectives .

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MECTA EMR 8/5/09 5 :30 PM

~ ._ .4

A.. 1 i... i N\OS . "~ L.~ I ON

~ae C' "'r c .,. .

i_i`~~t'+ j ., ~..'
. l . ..Ft_~1., . . . !_ ;~`~i ~. E!~t~i .. E, : ,\V 4t :.i .

Home n Products » spECTrum DEVICES » Options » MECTA EMR

View Cart » items in Cart : 01

Options DQM refers to U.S ./Canada
INT refers to all other countries
Hand-Held Electrodes
El,.oTA EM R
ional Monitoring Channels

Optical Motion Sensor New health IT mandates require digitization of patient medical records .
MECTA EMRO, an MS Access T" - based, networkable electronic
~ EEG Data Analysis medical record, will revolutionize the data acquisition of your ECT
treatments . The spECTrum 5000 alphanumeric data, physiological
P Remote Monitor Coftwarea monitoring and patient data inputted by psychiatrists, anesthesiologists
and nurses are imported into six permanent ECT medical records that
~ MECTA RM5 MANA.GER© can be saved as pdfs on your PC laptop or desktop computer . Improve
patient safety and privacy, contain costs and eliminate paperwork with
~ MECTA Efv4ROG
MECTA EMR .
Sturdy Hospital Cart

Y= spECTrum Devices Click to enlarge

~ Clinical Accessories

COt1ltlCt (IS

Refttae<-A tor Otlotatlr}r)

~Click to enlarge
Request for Service Ouote

Revolutionize your ECT team's management of patient data and

prepare for paperless medicine!

Ele,ctrowc rrieiiicGl records have been showi'i to improve patient

[~~ MECTA EMR data sheet DQM .>aft4 and r.veluce tirf;~~ : and Cos;s .

ECTA EMIR data sheet iNT I ie spECTrum physiological data imports directly into EMR. An
Mtc fill feature prevents needless inputting .

- )rtr:s include : Et, f Rcf,-'rr;_il Forrn . Pre,-Anesthesia E-~,°rah.iation

Fonn , Pre-EC T ^1,~rt;ing Checklicl, I: :C,'I 'Administration Records, ECT
A~r~ :iicr~tior~ I_c0 Wnc, Post-ECT PJurr;inrj Ri :.covc :ry 1-ReconJ .

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Optical Motion Sensor 8/5/09 5 :15 PM

t ,.

~.-1.is`'~~f~(."f~,'`d F :;~I~::~ i t:~t~ ;~~ ?;

i"it8111e » I''IuuUia » z5pCl..iluili iJLVil ..c.'.~ n o1;,)iaull~ n isiJt,ai i'vluilC9n Sensor

View Cart » Items in Cart : 0

Qptian6 C501VI refers to U.S ./Canada
INT refers to all other countries
~ Hand-Held Electrodes

~- . Additional Monitoring Channels

Optical Motion Sensor
~ Optical Motion Sensor Motor activity is commonly monitored during the course of the ECT
treatment. The MECTA spECTrum 5000 series Optical Motion Sensor
Data Analysis (OMS) with Velcrom' attachment is faster and easier to use than EMG .
The sensor is strapped to a finger or toe distal to the blood pressure
Remote Monitor SoftwareQ cuff, where its infrared sensor captures the intra-muscular motor
movement during the clonic phase. These slow wave movements are
A RMS MANAGERG displayed on the spECTrurn LCD monitor, chart recorder or PC
monitor where they may be stared, viewed, analyzed or printed using
MECTA EMRC) Remote Monitor SoftwareD, MECTA RMS MANAGERa Software, or
MECTA EMRO Sofbrvare .
~ Sturdy Hospital Cart

spECTrum Devi Click to enlarge

~~ Clinical Accesso

Contact US

Request for oklotawnt

,Click to enlarge
PTedtyE!~~st for SenAcrr otjofie~
Optical Motion Sensor is a tool used to detect intra-muscular motor
movement following initiation of a stimulus .

to

Ther~:. are no additional expensive electrode pad'

:, ur mc;sey ;ae~l>
a p ply .

Tife'Vei'.,10 tf',11? I,',r . :r 19 .E:S easy attac[',Illerlt of 111'-- (",r to the

patl~'rli. .

Display, print or record OMS traces using Remote Monitor

SoftwareG . :a7ECTA RMS MANAGERC Software, or MECTA EMR'~'
Software .

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MECTA Corporation - Electroconvulsive Therapy (ECT) Products 8/6/09 12 :34 PM

OVER THIRTY' F IVE YEA1

1... UR'4.I MODULAi I Oi V IN N OVATION

-(,~::~i F -)DI-1 ~=TS ;.~ L Irtd I=-.l f'~;'~1 `~E ¬~~~'i S:~ ~

Nome » Products

View Cart » Items in Cart : 0

spLCl-rum L;evices D4M refers to U.S ./Canada
INT refers to all other countries
~ spECTrum 500009'
~ spECTrum 500
MECTA spECTrum ECT Devices
The Newest Standard of Care Available Only From MECTA
~ spECTrum 40000''
The spECTrum 5000 and 4000 models are the fourth generation of MECTA's ECT devices . They continue to
r spECTrum 4000MT'.` be the most advanced ECT devices technically, while continuing to offer even more safety and effectiveness
clinically .
P Starter Kit
The 5000QO and Click image to view
~ Options
5000M *`A model devices
~ Clinical Accessories offer up to five channels
of ECG and EEG
monitoring, and one
Optical Motion Sensor .
The 4000Q*`" and
4000Mtm devices are
simply the 5000 devices
without physiological
monitoring capability.
Requestf'or Ottointion
The 500pQu and
4000Q T"' offer the user
flexibility with four
Request for Service Otiole stimulus parameter knobs
to control Energy and
Charge . The 5000M" and
4000M'" units offer
simplicity, with one single
pECTrum Brochure Stimulus Intensity knob .
This varies Frequency
and Duration
.-_ Ultrabrief data sheet DOM simultaneously, to control
Energy and Charge .
t;1 Ultrabrief data sheet INT Each spECTrurn device is
custom manufactured to
user specifications
according to the Options
selected and includes a
complete Starter Kit .

spECTrum ULTRABRIEF~ ECT (o ., ms)

Experience Optimized Patient Outcomes with the Newest Dosing Methodologies

No other ECT manufacturer provides a proven evidence based methodology as simple and effective to use as
the spECTrum ULTRABRIEF@ (0 .3 ms) ECT feature. This feature was designed and tested at Columbia
University in the late 1990s, results were reported4s,4s and it was introduced as a feature into MECTA
spECTrum ECT devices in July of 2003 .

Right unilateral (0 .3 ms) ultrabrief six times seizure threshold ECT is equivalent in efficacy to a robust form of
bilateral ECT with little sign of cognitive deficit and is simplified by the use of the MECTA spECTrum titration
tables . Stimulus dose titration tables are included with each purchase .

No other ECT device implementation of' an ultrabrief feature is based on peer reviewed, randomized, double-
blind studies . Only spECTrum ULTRABRIEF (0 .3ms) ECT is highly efficient at the lower range, with patients
demonstrating seizure thresholds at 5 mC, and can treat the patient across the entire range .

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MECTA Corporation - Electroconvulsive Therapy (ECT) Products 8/6/09 12 :34 PM

Only MECTA offers hospitals a state of the art ECT device and ultrabrief option that provides the highest
benefit by reducing side effects for patients .

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Remote Monitor Software 8/5/09 5 :12 PM

_ 'E'r1.1~=3_`' {~..L11 -j j . .d ; IN ~ ~=~L. :\~1 I L- . CON{,`iC~ 9

Home » Products )> spECTrum DEVIU~- :, tt upuui i~ 7! I\Glil4te Monitor Software

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Options DOM refers to U.S ./Canada
INT refers to all other countries
t Hand-Held Electrodes

~ Additional Monitoring Channels

Remote Monitor Software
~ Optical Motion Sensor The Remote Monitor Software"' (RMS) option allows the user to set up
a remote monitoring display and data storage system for a spECTrum
~ EEG Data Analysis 5000 model, using a PC and monitor . This also facilitates using a
remote overhead display, particularly useful when using hand-held
r Remote Monitor Software@ stimulus electrodes . The monitor will display and log the physiological
monitoring seen on the spECTrum's LCD screen . For six channel
V MECTA RM5 MANAGERO spECTrum systems, all traces will be displayed simultaneously and in
real-time . RMS is a useful data capture tool for physicians,
MECTA EMR`
anesthesiologists and researchers .
Hospital Cart

spECTrum Devices Click to enlarge

¬= Clinical Accessories
: Combined with MECTA RMS MANAGERO
database software, realize the superior benefits
of a fully-featured ECT data capture and
analysis system
Contact Us

Request for Ouotation

Request for Ser%nlce t7ttote

View up to eight traces of real-time monitoring on a PC monitor: 4
EEG, 1 ECG, 1 bMS and 2 duplicate EEG traces .

Trf;atrndsnt parametcrs, patla;it data and, the t,pC_CTrum in-q1~~:aanc~c

Rernote Monitor Software data uiaplay also ;if}pi~~!~r on the I'{; rn%;nitor tu rnr,ur~; p;atient Saf+::t:i .
sheet DdM
Remote Monitor Software data i- iy<;ialogicai monitoring and treatment data may be stored for later
sheet INT 1a!ysi,~ . d~sir~ ; i m :~nagement or treatment assessment .

.iI _ G 1A f n''S N1/11,1~v~,(, ; i_f `' ior ~utnr,'i :~tF d imp :~itation c ;f I .,~I :;
ifa fi =: irtn a n i>x"i mc~h:~ v2 ~~~til~ ; ~irul : ; 'tsy to-u :_,c:

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MECTA RMS MANAGER 8/5/09 5 :11 PM

J f" () 'I`0" I t- 11L C) N' 1 N N () VAI 10 N

i ACT)lI J C T'~-1 ,(_'_!M~_

1 ~ i- i -) N I-At - T'
~ 11 1 ii- 1~
rj 7,
;CIA!-~ -- r - I

Home )) Products » spECTrum DEVICES » Options >f [ULc.;l

View Cart » Items in Cart : 0

Options f2OM refers to U .S ./Canada
INT refers to all other countries
~ Hand-Held Electrodes

f- Additional Monitoring Channels

lY .A 3J 1s 1 L .1 RM S MA NAGE
[- Optical Motion Sensor This groundbreaking software program combines seamlessly with
Remote Monitor Software© (RMS) and either spECTrum 5(300 model
EEG Data Analysis to automatically import ECT treatment data into an extremely versatile
and easy-to-use database . With MECTA RMS MANAGER© collect up
Monitor Softwaree to 52 data fields, including 10 user-defined fields, sort, select, query,
print, incorporate notes, backup, and export to Excel and other
MECTA RMS MANAGER0- commonly used programs .
MECTA EMR0`

rdy Hospital Cart

ECTrum Devices Click to enlarge

~ Clinical Accessories Used with a PC laptop or desktop computer,

MECTA RMS MANAGER is the only ECT
software program needed to organize and
analyze the ECT treatment data .
{>Otttat",t Us

Request for 011otation

C~ick to enlarge
ItFyctttestfor Service 014(Ae
MECTA RMS MANAGER is a powerful database program to
manage ECT treatment data .

F'atient data anrt monitoring are captured and automalically imported

ECTA RMS MANAGER data fron) tie spEC-1 rum 5061,i cieviw rmct Ferr?ct~= [,J1onit(_)r :>cftwrare
sheet DOM
CTA RMS MANAGER data - Up to 52 coluIr~ns Of Patient information is available, including 10
INT usei ..clE . ;ined ht.;Ids

Sort . S ;:I~.:ct . C ;7nery, t'r1r~C incorporate P9o1F>s, Backup, and Expml to

Excra L,nd otlit-r clornmonly use ;~1 proqrarns .

based on the Windows Access Ern format, MECTta Rrv15 hl1ANAGER

is extremely versatile and easy to use .

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MECTA spECTrum ECT Devices - spECTrum 5000Q® 8/5/09 5:05 PM

.
S R~=.:..~' t

IV.j k, () i4``10

._ 14
[!L.IC++, L( NI .- I AN E ;~`:' 1,, r_ i~ ~ht TAiW T

Home » Products >) spECTrum DEVICES ?> spECTrum 5000QO

~ s_a ." . .
View Cart >) Items in Cart : (3
spECTrum D^.;vices D(JNI refers to U.a .ICanada
It+iT refers to all other countries
a~ spECTrum 5000Q©
SpECTru121 5000Q`
~ spECTrum 5000MTM
4000Q-
~ spECTrum

~ spECTrum 4000MM

~ Starter Kit

~ Options
Clinical Accessories

Contact Us

Request ftif C)euotation

Re(Itiest for service 0c1nte

iar

The spECTrum 5000QO is MECTA's top-selling device . It offers maximum flexibility to treat with four
ECTrum Brochure individual parameter sets of Pulse Width, Frequency, Duration and Current . The treatment dosage is set
using the four knobs beneath the LCD touch screen so that the user can easily see and quickly choose the
best treatment option to maximize efficacy and reduce side effects . The spECTrum ULTRASRIEF© (0 .3 ms)
pulse width settings and titration tables are included with all MECTA devices .

The base unit includes a choice of two channels of EEG or/and one EEG/ECG arrangement. Add up to four
more channels of monitoring for four channels of EEG, one ECG and one Optical Motion Sensor (QMS) .
EEG Data Analysis, Remote Monitor Softwarea, MECTA RMS MANAGER© and MECTA EMRO software
options may be added for a fully featured device .

Individualize patient treatments for safety and effectiveness with the 5000's nine menu options : Main,
Patient Data, Date & Time, LCD Traces, LCD Gains, Chart Traces, Chart. Options . EEG Data and the
Parameter Selection menus . One menu display is available in the 4000 models . The LCD touch screen
provides the user with an easy interface to set menu options .

The new 5000 models have been enhanced with lighter-weight RoHS (lead-free) cases that provide
enhanced durability (3 Ibs . lighter) . The new robust handle ensures easy repositioning . Touch screen
advanced technology offers increased sensitivity and clarity .

MECTA devices also include extensive redundant hardware and software testing to verify that they are
operating correctly . The safety of these devices is unparalleled, and as such these devices are an advance
that dramatically impact the safety and effectiveness of the ECT treatments .

For hospitals, clinicians and researchers who desire the

optimal functionality and the features of the psychiatric field's
, top-selling ECT device

,.r : :r:erc> rna;:imt!n~ fl_z~xibi~it,r and Ch~~ ~Nidtat ranr:3~r ,~f trr: ;arr)~~ni_
: f)=JrySTlt,i£ifS Is (iia~m'a'1 for ieCiIJCt!On of ,ilfJ~E9-Lf~"-4CI5

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MECTA spECTrum ECT Devices - spECTrum 5000Q® 8/5/09 5 :05 PM

When up to six channels of real-time physiological monitoring

and EEG Data Analysis are needed to provide the clinician
with additional patient information

Vvi.en cnh ::n :;ed data cat)tr .!re irs rc:~7uired eifhc :r ihrough,
physiological ir!oni oring or recordin,t tr=saiment ar!cJ ; ;;rr !?nedical
infor!nai:ior!

spECTrum ULTRABRIEFO (0 .3 ms) option with up to sixteen

therapeutic treatment parameters

1'Jlrr~ vit3udl . e~ .sy to use rnenus ~ :+c< :e ;:sed by the LCD touc ;Pi
screen ,o individualize paticrit E:rc:r~ln7cnts . No hard to find
menus

New enhanced, lighter-weight RoHS (lead-free) case for a

smaller footprint and more robust handle

Extc.nsr,re regulatory rar,inricy rat>provals vvorJd~i~irie U .5 ~tJLj :

Canada (C ;a1's . Health Canada 8 P,pprov<31 ;,, #153y . ~tr~~ `>"?' .
#K57G) : F:arropean l.lrion . TUV (i=.kl L'__~O
;;48 .`'M03{AC ~'v07 : C :fdiDCAS IS(:, ~"AK, '2C;0 := EG
0"-'!4'2/EE-',` 1 i f,rt!cle 3) : Kor-sa (KFDr'~i Aos-tr :.rl!~
(TGA,,

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MECTA spECTrum ECT Devices - spECTrum 5000M'" 8/5/09 5 :06 PM

NE

~ 'rti,.;~~ a ~r-IE
HN f,.--IAN S~ I { .E

Home » Products » spECTrum DEVICES » spECTruni ;;~; :u~Ji`11~"'

View Cart }> Items in Cart: 0

. spECTrum Devices DqM refers to U.S ./Canada
INT refers to all other countries
spECTrum 500000 5000MTM
spECZ'1Lll11
; spECTrum 5000MT"'

p- spECTrum 40000T"

~ spECTrum 4000MTr'

Starter Kit

y Options
Clinical Accessories

CQrrFaet Us

~'tec;uest fut t5,ttotatioTb

Request for service otattte

The popular spECTrum 5000M T`°' offers dosing simplicity with one single Stimulus Intensity knob . This varies
1, spECTrum Brochure Frequency and Duration simultaneously, to control Energy and Charge . For those used to a single stimulus
knob, the 5000M model is the best option in dosing flexibility, while retaining~arameters that maximize
efficacy and reduce side effects for the patient . The spECTrum ULTRASRIEF° (0 .3 ms) pulse width settings
and titration tables are included with all MECTA devices .

The base unit includes a choice of two channels of EEG or/and one EEG/ECG arrangement . Add up to four
more channels of monitoring for four channels of EEG, one ECG and one Optical Motion Sensor (QMS).
EEG Data Analysis, Remote Monitor Softwarea, MECTA RMS MANAGERa and MECTA EMR© software
options may be added for a fully featured device .

Individualize patient treatments for safety and effectiveness with the 5000's nine menu options: Main,
Patient Data, Date & Time, LCD Traces, LCD Gains, Chart Traces, Chart Options, EEG Data and the
Parameter Selection menus . One menu display is available in the 4000 models . The LCD touch screen
provides the user with an easy interface to set menu options .

The new 5000 models have been enhanced with lighter-weight RoHS (lead-free) cases that provide
enhanced durability (3 Ibs . lighter) . The new robust handle ensures easy repositioning . Touch screen
advanced technology offers increased sensitivity and clarity .

MECTA devices also include extensive redundant hardware and software testing to verify that they are
operating correctly . The safety of these devices is unparalleled, and as such these devices are an advance
that dramatically impact the safety and effectiveness of the ECT treatments .

For hospitals, clinicians and researchers who desire optimal

functionality and features with the most ease of use

On . heatrn, r,i I ;noh for simph ; iy in 'i 3L:-ps ~iy Fr :;ueffa~

and C}~.~rat;i~n r,!rnr;ltan~>ously, to ~,ontrol 1-nergy 3!id Char~,~

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MECTA spECTrum ECT Devices - spECTrum 5000MT°° 8/5/09 5:06 PM

When up to six channels of real-time physiological monitoring

and EEG Data Analysis are needed to provide the clinician
with additional patient information

U'Vhun enhanced dal iriture i>; r4qH-rJ ;:ifihwr Wudh

p rr~= i Ic,clic~~l nn . :iii'oring or r~ r i a,ng iAati'n4 ::rit 2iru1/or rre:ric: I
irYForrrlai:`on .

s;pF-LT :un ; L&i I-.F{t31 E1 = am,,j option 50 up to si u:er

U"rapeu6c tre :h-nt:rrt paimrn :.-ler<s

We uYuN easy to u E, menus a .c:.ss. .1 hy the l .C L? trauch

screen to irrdlvidujliz--~, ha~ient treatnants . No har,,J to find
ni enus

Qw ,.nr~anr-~d . lic;lrie;r-weicht RUT (KAWY case Or

~rr:<aller footprint antl more ror ;ust handle
.'=
L,ft~nsiv;; rcr7ulatory agency approwns world0do L15 _ (UL) :
C< :n ;da (C<>i; Health Canada 8 A,pprovalr; . 41537 , :1G6i: :}78 .
/k;~2b76) ; ~.uroi~c .,~r; Union, Tt,l',l (EN Ic;0
13= : :_-.`10 .+H,C :<OQ+ : CUCbCAS ISO 134t35 :2
93,q 2T [==(; Annex 11 Artidr ; ; Woo lP;r=CrAr hW'rtlia
(! GA)

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Home » Products » spECTrum DEVICES » spECTrurri 'tiU00Ct T'

View Cart » Items in Cart: 0

spECTrum Devices DQM refers to U.S ./Canada
fNT refers to all other countries
TM
spECTrum 5000QO . . :
spECTlUm 4QQC3Q
spECTrum 5000MrM

~ spECTrum 4000QTl'

f~ spECTrum 4000MTM

~ Starter Kit

~ Options
Clinical Accessories

contact IN

Request for (Af0tatiorr

Request for st;rtiAcca 0ilure

This re-designed spECTrum 4000QTtA is more economical, light-weight and portable than the 5000 . The
pECTrum Brochure 4000Q T`" model offers flexibility with four parameter sets of Pulse Width, Frequency, Duration and Current.
The treatment dosage is set using the four knobs beneath the LCD touch screen so that the user can easily
4000Q/4000M data sheet DOM see and quickly choose the best treatment option to maximize efficacy and reduce side effects for the
patient . The spECTrum ULTRABRIEF© (0 .3 ms) pulse width settings and titration tables are included with all
MECTA devices .
4000Q/4000M data sheet INT
As the ECT section of the 5000 devices, it offers cost effectiveness without h siolo ical men still
ensures that the clinician has all of the technology, safety and effectiveness of the 5000 spECTrum .

Where maximum flexibility to select treatment parameters is '

desired

V' !,~+ .r~~ altarra!i+rc~ monit,(rl :~c; is avail~5bl~~

h, high de,3rce ai pc,ltability i7 I~ .c;luir~(9

!; cost-effectivwititi: ss is a I :rriority

spECTrum ULTRABRIEFQ {0 .3 ms} with up to sixteerl

therapeutic treatment parameters

SIX w'.Ctli6.'. IYIf'.Il"I~-Jrel!"li3 rl`JJI'Gflc3s 1jdlti', Orllti' Orlt1 ScIGCtlorl r11()Ilu

F;_:t3ust h<1r ;dle- _ ;>I7!~III ioolr>rir ;t and licql1i~rebrjht casc-

: a~n ~~. ~c~ ul I :x ;~ ,In,c atcy arpr~lc ~,ra _ 4r,r,rla~r~!d~ : L

Ca,ada fC; ::,A 1-1r;;rllJl Car!L!d,a 3 P,I:rI>rorals ;!-1 :`
~ f,i', ~!!! ;pean l l!' ;1!:ril . TL!',/ ;',i=h! I60
,
134~11'__', ()U'1~ +AC .2J!!7 ; CNIDC ,' ISO :485 : ~3 : LC

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MECTA spECTrum ECT Devices - spECTrum 4000QT" 8/5/09 5:06 PM

93/42'EE :", T, i i :r: 1 i r,-:a (Kr-,[)A), : ALstrniia

i 1-G, N

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MECTA spECTrum ECT Devices - spECTrum 4000MT"° 8/5/09 5:16 PM

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.¢ spECTrurn 5000QO. TM

spECTrurn 5000M
TM spECTrum 4000M
~_ spECTrum 4000QTM

~ spECTrum 4000MT'.°

Starter Kit

f Options
A Clinical Accessories

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FteqItost tot set'vice Quote

This re-designed, economical and light-weight spECTrum 4000M'N' offers dosing simplicity with one single
,~ spECTrum Brochure Stimulus Intensity knob . This varies Frequency and Duration simultaneously, to control Energy and Charge .
For those used to a single stimulus knob, the 4000M model is the best option in dosing flexibility, while
4000Q/4000M data sheet DC3M retaining parameters that maximize efficacy and reduce side effects for the patient. The spECTrum
ULTRABRIEF© (0 .3 ms) pulse width settings and titration tables are included with ail MECTA devices .
4000C!/4000M data sheet INT As the ECT section of the 5000 devices, it offers cost effectiveness without h siolo ical monitorin , but still
ensures that the clinician has all of the technology, safety and effectiveness of the 5000 spECTrum .

implicity to treat is a functional requirement

'JV!-ie:re: a!1:ernat.ve rY}onifu,ina i :, av_all,abl,~ ;

, , !-r~c; ;; d~grr;-:: ot r;ortabi!i!.±; i ; requir, ci

spECTrum tJLTRABRIEF° (0 .3 ms) with up to

therapeutic treatment parameters

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~ spECTriam 5000Q6
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t spECTrum 5000M7°"

~ spECTrurn 4000Q'" An extensive starter kit is included at no charge with the purchase of
any spECTrum 5000 or 4000 ECT device (kits may vary according to
~<. spECTrum 4000MTM the model ordered) . By supplying everything the clinician and biomed
need to get started, MECTA ensures a turn-key startup. Manuals and
~ Starter Kit visual aids, test equipment and clinical supplies assure hospital staff
that treatments can begin promptly, efficiently and efficaciously . All
t Options starter kit items have been designed, tested and approved to comply
with their respective regulatory standards . Therefore, these clinical
Clinical Accessories
accessories offered by MECTA for use with the spECTrum 5000 and
4000 series ECT devices are recommended. Purchase additional
clinical accessories from MECTA for competitive pricing, quantity
Click to enlarge packaging, flexible delivery options and guaranteed quality for all
Contact US starter kit consumable supplies .

bent Stimulus Cahic. Chart Recorder Paper

Request for otiotallon F -II '~ll :i,~futir P,~IC nitOr r8f~lr' F it~: ¬ liocb.

! EEG and/or ECG Le<id~~ Ob~_,rto Mouth P'roi:.

Adjustahlf-- I-1c .iclbarid Fl~~ctrod :: c:;ei

Request for Service Otiole
Flat Stimulus Electrodes Ft~ :;ctrod_ Paste

Sliniulu : t=1=ootrorlHs EC,ca Di!~.posablc F ltrtrod,i'ads

Fuse (2 or a Amp) EEG Disposable Electrod :i i',acl :,

ifins()r ; Lo ;:id Box

Dynamic

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Stimulus Electrode Site Preparation
I. DEFINITIONS
Redux Paste
MECTA part #9800-0002
Manufacturer - Hewlett Packard
Conductive gel with abrasive material

Redux Gel -
MECTA part #9800-0001
Manufacturer - Hewlett Packard
Conductive gel

II. GENERAL INFORMATION

The ECT device provides an electrical current that is directed to the brain via a pair of metallic
electrodes . The electrodes are electrically connected to the stimulus generator through the Stimulus
Cable or Handheld Electrodes .
In order for the current to reach the brain, it must follow a path between the electrodes. Since the
blood is conductive (hemoglobin), the capillaries, arteries and veins act as the conduction system to
the brain. By maintaining adequate contact between the electrode and the skin, the energy path is
maintained .
The skin is inherently a non-conductor, with increasing resistance (impedance) to current flow on the
external skin layers. When the electrode site is properly prepared, low or high impedance is avoided,
and treatment can be performed successfully.
The MECTA sPECTxUM provides a continuous display of patient impedance . Static impedance testing
allows a small amount of current to pass through the electrodes to assess whether impedance is in
range. Abnormal impedance readings may result from:
" Improper type of paste or gel as approved by FDA/CE for use with the sPECTRum .
" Smearing of conductant between the electrodes .
" Buildup of hair conditioner, hair spray, gels or creams on the skin.
Proper and consistent use of Redux gel and paste ensure impedance is in range for effective and
consistent stimulation .

III. WHEN TO USE PASTE AND/OR GEL

GEL - Use with each treatment . May be used alone when skin is ductile and compliant and on areas
that are smooth.
PASTE - Used in addition to gel . It is helpful for use on older patients; in areas where skin is not
protected by hair; when the skin surface is not smooth (wrinkled) ; and when SELF TEST has indicated
that impedance is too high. It is also used on areas where there is a lot of hair (The paste allows more
volume of conductant (gel) to be applied to a specific site. It does not run or drip). May be used to
slightly abrade skin prior to treatment in order to remove dead skin cells .
IV PROCEDURE (Using Both Paste and Gel)
Always start with clean, dry skin and clean electrodes. Using a gauze pad, swab the skin beneath the
electrode site with acetone (gentler on the skin), or alcohol . Allow the site to air dry for a few seconds
and then apply a small quantity of REDUX PASTE onto the skin under the ECT electrode site. Gently rub
in, taking care not to overly abrade the skin. Remove excessive abrasive grains using a gauze pad or
cloth. Do not use wipe with alcohol because discomfort may result.
Apply REDUX GEL to the ECT electrodes. The electrodes should be uniformly covered in gel. A tongue
depressor may be useful to create an even spread. Care should be taken not to use too large a quantity
of conductant to avoid spreading outside the electrode area when it is placed firmly against the scalp . A
small quantity of gel should also be rubbed into the skin .
If skin is smooth and clean, the application of paste may be eliminated, although it is helpful in
lowering impedance.
For use on the scalp, part the hair, rub the scalp with solvent, and apply paste. Gel should be applied
onto the electrode as above .

V WARNINGS & CAUTIONS

" OTHER gels are not recommended. Do NOT use gels that are designed to be used on ultrasound or
Dopler devices. Multiple use gels are generally not suitable . Failure to use recommended gel may
result in local skin burns or SELF TEST FAILURES.
" Smearing of conductant between electrodes will create an alternate path for the treatment current.
More current will pass through this direct path between the electrodes, lowering impedance, making
it difficult to elicit seizure. Failing to use gel or inadequate contact (pressure) will often result in a
local focus (skin burn).
" To ensure the best connection between the electrode and the patient, the SELF TEST should be
performed immediately prior to stimulus delivery.
" Both gel and paste are water based - the tube cap must be replaced. Use of insufficient, incorrect or
expired gel (3 years) may result in less than optimum results.

If you have further questions, we would be happy to refer you to one of the clinicians
who are currently using MECTA products.
 SPECTRUM ULTRABRIEF'J

ULTRABRIEF ECT -ENSURING EFFICACY

WHILE MARKEDLY REDUCING COGNITIVE SIDE EFFECTS
These landmark parameters were introduced in the Fall 2008 confirms that right unilateral ECT given at 6 times
of 2003 by MECTA and already are having a major impact initial seizure threshold with a 0.3 ms pulse width is
on the field .', I Controlled research at Columbia equivalent in efficacy to the therapeutic effects using a
University has shown that the 0.3 msec ultrabrief pulse robust form of bilateral ECT (1 .5 ms pulse width and 2.5
width sharply reduces seizure threshold, allowing times seizure threshold)3 Right unilateral ultrabrief ECT
treatments to be given at much lower electrical dosage is a clear advance for the field as patients show rapid
than had been previously possible. Most critically, when improvement with little sign of cognitive deficit . The
compared to standard brief pulse stimulation, use of sPEG°ISiuMs offer the only ultrabrief parameter set that
ultrabrief parameters results in a profound reduction in allows for ultrabrief pulse stimulation across nearly the
cognitive side effects. In many domains, this advantage full output range of the device. All four sPECTRuM units
for ultrabrief stimulation is as large or larger than the can be upgraded to include this new form of stimulation
difference between bilateral and right unilateral ECT in as a menu selection.
their cognitive effects. Definitive research published in
1 . Lisanby SH MD, sackeim HA PhD :New developments in convulsive therapy. Epilepsy & Behavior 2001 ;2 :S68-73 .
2 . Sackeim HA PhD:Convulsant and andconvulsant properties of ECT:towards a focal form of brain stimulation.Clinical Neuroscience Research 2004;4 :39-57).
3 . Sackeim HA PhD et a1:Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimulation 2008;2 .

Contact MECTA for pricing and upgrade information and also to order
Titration Tables and/or a new MECTA Instruction Manual containing
the instructions for using these new stimulus dosing parameters.

ECT PARAMETERS/ 100 JOULES SYSTEMS

New! sPECTRDM
9 Models Ultrabrief
Four Parameter Sets: Set 1 Set 2 Set Set 4
Stimulus Current in 100mA increments 500-800 mA 500-800 mA 500-800 MA 500-800 mA
Frequency in 10-Hz steps 20-90 Hz 20-60 Hz 20-60 Hz 20-120 Hz
Pulse Width in .10 msec steps 0 .5-1 .0 msec 0 .5-2 .0 msec 0 .5-1 .0 msec 0.3-0.37 msec
Stimulus Duration 0 .5-4.0 sec 0 .5-3.0 sec 0 .5-6.0 sec 0.5-8.0 sec
Charge 5 .0-576 mC 5.0-576 mC 5.0-576 mC 3.0-568 .3 mC
Energy C 220 ohm patient impedance 0.6-101 .4 joules 0.6-101 .4 joules 0.6-101 .4 joules 0.3-100.0 joules

New! sPECTRuM
MModels Ultrabrief
Four Parameter Sets: Set 1 Set 2 Set Set 4
Stimulus Current 800 MA 800 mA 800 mA 800 mA
Frequency in 100 settings 20-90 Hz 20-120 Hz 20-60 Hz 20-120 Hz
Pulse Width 1.0 msec 1.0 msec 1.0 msec 0.3-0.38 msec
Stimulus Duration 0.18-4.0 sec 0 .18-3.0 sec 0.18-6.0 sec 0 .5-8.0 sec
Charge in 100 settings 5.8-576 mC 5.8-576 mC 5.8-576 mC 5 .8-576 mC
Energy @ 220 ohm patient impedance 1 .0-101.4 joules 1.0-101 .4 joules 1.0-101 .4 joules 1.0-101 .4 joules

MECTA Visit our website at www.mectacorp .com

hVIDENCE
ro
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 19799 SW 95th Place
Suue B, Building D
Tualarin, Oregon 97062

February 15, 2001

To whom it may concern :

Subject: spECTrum Safety Information

The spECTn.im ECT units have been designed and are tested to the highest standards applicable to
non-invasive devices, and have FDA, ISO 9002, and CE mark approvals, as well as other electrical
standard approvals such as UL and cUL . The documents accompanying this letter document the
safety features of these devices .

The Essential Requirements/Standards Checklist lists in detail the Essential Requirements outlined in
the Medical Device Directive of the CE community, as well as the tools and means used to ensure the
design, manufacturing and usage of the units conforms to the requirements .

The Hazard Analysis addresses potential usage hazards . It lists each potential hazard and the
approach used to address that hazard.

The Clinical Risk to Intended Benefit Analysis summarizes relevant research and expert opinions about
ECT usage and practice . It specifically covers the various treatment parameters and energy related
issues of MECTA spECTrum units, including the benefits of 200 Joule machines.

MECTA's manufacturing process includes extensive testing of every single unit shipped from the
factory. In addition, spECTrum units run extensive self-tests every time the unit is turned on and every
time a treatment session ends. Finally, the units continuously run many internal tests whenever the unit
is on . The Overall Quality Plan document summarizes this testing plan.

SpECTrum units deliver a predetermined charge (in milli-coulombs) to the patient . This charge is fully
determined by the current, pulsewidth, frequency and duration of the delivered pulse train. These
parameters are directly controlled by the knobs on the front panel . The expected energy delivery
(based upon a dynamic patient impedance of 220 ohms) is displayed as an aid in choosing the desired
stimulus level, and is limited to 100 or 200 joules depending upon regulatory requirements in the
destination country. During the delivery, both software and independent backup hardware monitor the
current, pulsewidth, frequency and duration . Any deviations from the specified values cause
termination of the energy delivery. In addition, the delivery terminates if the delivered voltage ever
exceeds 400 volts . These safeguards, the most extensive in the industry, ensure correct energy
delivery each and every time. The allowed tolerance on each of these parameters is 10% or less .

Sincerely,

(
John Shaw
Quality Manager
MECTA Corporation
I have enclosed the final report from Dr. Harold Sackeim for you to
review. I would be sending you copies of the bibliography if they are
required under separate cover with the ORIGINAL REPORT . THEY
~: WILL COME BY FEDERAL EXPRESS TO ARRIVE
_ ON FRIDAY OF
~THIS WEEK 6/26'1`1997."-"-;'- ."
 JUN-16-1997 18 :29 DEP1 B1U rbruniHiRi

College of .~hyPhysicians &Surge orlsofColumbia University I NewYork, N.Y.10032

Harold A. SacScolm, Pn .D. 722 vvest 168tn Street, Unit 72
Prafesaor of Clinical Psychology in Psychiatry Telephone: (2'12) 980-5855
Chief, Department of Blological Psychiatry Facsimile: (212) 960_5854
New York State Psychiatric Institute amail: has-I eecolumbia.edu

June .12,1997

Dr. med. Beate Henrikus

Cnical Affairs
TUV Product Service GMBH
r'h' dlerst.age 31
80339 M!~nchen 2
Germany

Dear Dr. Henrikus:

I am writing to provide a clinical evaluation report of the MECTA SR1/2 and JR1/2
devices used in the delivery of electroconvulsive therapy (ECT), and produced by
the MEC.'rA Corporation (7015 S_W. McEwan Road, Lake Osweao, Oregon 9~'305,
US). Th?~; report is intended to meet the recjuirej:inents of EC- Directive 93/ ''/EEC
(MDD) . I end the report with a description of my experience with the new MECTA
spECTrn::m 5000 series and compare its features to the earlier MECTA SR1/2 and
JR1/2-

Backgraund
Enclosed is a copy of my curriculum vitae. I have been engaged in clinical provision
and research on ECT since 1979. I am a member of the American Psychiatric
Association Task Force on ECT. I hold a MERIT Award from the National Institute
of Mental Health (USA) for my research on the affective and cognitive consequences
of ECT. i supervise separate clinical services that provide ECT at the New York State
Psychiatric Institute and the Presbyterian Hospital at the Columbia-Presbyterian
Medical Center. I direct a large research pro~am on ECT as Chief of the Department
of Biological Psychiatry, New York State Psychiatric Institute and Professor of Clinical
Psychology in Psychiatry and Radiology, College of Physicians and Surgeons of
Columbia University. I have substantial experience with the use of these NIECTA
devices in routine clinical care and in carefully controlled research projects .

Device Description
The MMC.'TA SRI/2 and JR1/2 devices are used in the administration of ECT. Each
device delivers a constant current, bidirectional, brief pulse waveforrn . . The SRI and
JRl models allow the practitioner to independently vary pulse frequency, pulse
width, tJ~ain duration, and current (pulse amplitude) . The SR2 and JR2 devices
provide a single control that varies stimulus output from 5 to 100°o by line3ily
JUN-16-1997 18 :29 DEPT BID HSY~,H i N i K T 1 1- rvu ,
--

Page 2

increasing pulse frequency and train duration . With the SR2 and JR2 devices pulse
width is fixed at 1 ms and current is fixed at 800 mA. Other than this difference in
control over stimulus characteristics, the four devices are identical with respect to
ECT stimulus delivery features. Common features include the requirement to pass a
"self-test" that assesses integrity of the electrical circuit prior to arming the device for
stimulus delivery, calculation and display of the dynamic impedance encountered
and the energy and voltage administered during delivery of the ECT stimulus, the
capability to use remote hand-held electrodes for stimulus delivery, Qtc.

The SRI/2 models are distinguished from the JRl/Z models by the capacity to record
up to two channels of physiology (EEG and/or ECG), and to display the physiology
and computations of stimulus characteristics on a chart recorder . Specifically, the
jR1/2 models lack these capabilities.

Other details about the particular devices can be found in the SR/JR Domestic
Instruction Manual (pages 1-14,16-17) and the SR/JR British Instruction Manual
(pages 1-13,16-17) . The book, The Practice ofEIectrncn=ulsive Therapy_
Recommendations for Treatment, Training, and Privtleging, by the American Psydtiatric
Association Task Force on ECT (APA, 1990) contains information comparing devices
from various manufacturers (pages 165-166) . Similar information is provided in
the report by the Royal College of Psychiatrists' Special Committee on ECT, The ECT
Handbook (pages 122-148) (RCP, 1995).

Intended use/indications/contraindicatioxns
ECT should be considered only for suitable patients with selected psychiatric
disorders . A combination of factors determine if and when the use of ECT is
considered . These include the patient's diagnosis, the nature and severity of
symptomatology, treatment history, evaluation of the anticipated risks and benefits
of alternative treatments, and patient preference.

By far, ECT is the most commonly administered in the treatment of patients with
major depressive disorder . ECT is widely considered the most effective form of
antidepressant treatment currently available (Sackeim et al., 1993, 3.995). There is
also substantial evidence regarding the efficacy of ECT in acute mania (Iviukh .erjee et
al., 1994) and schizophrenia (Krueger & Sackeim, 1995). .Although ECT may be of
clinical value in other selective conditions, such use is rare.

Regardless of diagnosis, most patients receive ECT after failing to respond to

alternative pharmacological treatments . One of the factors leading to referral to ECT
is a history of resistance to adequate pharmacological treatment . For instance, there
is substantial evidence that a high percentage of patients who do not respond to
adequate trials of antidepressant medications have a strong response to ECT (Prudic
et al., 1996). ECT is also considered when patients manifest unacceptable side effects
with alternative treatments or when such treatments are deemed to present
excessive risk. Particularly with respect to some types of cardiovascular disease, the
likelihood of sigrnificant medical morbidity or mortality will be less with ECT than
.7Uw-16-1997 1e :3H DEPT BID r5rL-M1HsR~

Page 3

with some pharmacological alternatives (Zielinski et al., 1993). ECT is also

considered when there is a particular need to ensure that a patient has rapid and
definitive clinical improvement. Relative to pharmacological alternatives in the
treatment of major depression, ECT often has a greater probability of resulting in a
clinically significant response, as well as greater speed of improvement (Sackeim et
a1 .,1995). For patients who present with psychiatric (suicidal) or medical (inanition)
emergencies, these characteristics prompt consideration of ECT. Finally, history of
previous response to ECT (and alternatives) and patient preference are additional ,
factors that contribute to decision making.

There are no absolute contraindications to the use of ECT (Al'A, 1990) .

Undoubtedly, the medical risks of ECT are substantially heightened in specific
circumstances . However, even in circumstances where the risks are substantial, use
of ECT may be compelled by a determination that alternative treatments or no
treatment likely have inferior risk-to-benefit ratios. The risks of ECT are
substantially increased in conditions associated with elevated intracranial pressure
(e.g., space-occupying cerebral lesions), in patients who can not tolerate brief
peripheral or central hypertension (e.g., bleeding or otherwise unstable vascular
aneurysm or malfonnation; patients with unstable cardiac conditions, such as after
myocardial infarction), and in patients with other selected conditions (retinal
detachment, pheochromocytoma, increased anesthetic risk).

The indications and relative contraindications for ECT are independent of the
device used in ECT administration . Additional information on the indications for
use of ECT may be found in the APA (1990) Task Force Report (pages 6-9, a_9--57) and
the RCP (1995) Special Commit-tee Report (pages 3-23). Information on
contrainiiications may be found in the AFA (1990) Task Force Report (pages 9, 57-59)
and the Royal College (1995) Special Committee Report (pages 26-29).

Therapeutic Effects of the Device

The purpose of administering the ECT electrical stimulus is to trigger a self-finii.ting
generalized seizure. The application of the electrical stimulus and the elicitation of
the seizure can have profound therapeutic effects in specific therapeutic conditions
(Abrams, 1997) .

Over the last 60 years, a wealth of data has accumulated with respect to the efficacy of
ECT in specific psychiatric conditions . Furthermore, there is considerable clinical
experience and a body of research reports explicitly using the MECTA SRI /SR2 and
JR1 /jR2 models .

With respect to major depression, a series of .shazn-controlled trials conducted in

England in the 1970's and 1980's compared real ECT to the repeated administration of
anesthesia alone (see Sardceim, 1989 for a review) . This work controlled for much of
the psychological factors surrounding use of ECT (e.g., high expectations for remission,
repeated and stereotyped procedure, etc.) and established that the short-term.
antidepressant effects of ECT are greater than those of anesthesia alone . More recent
JUN-16-1997 1B :31 DEPT BID PSYCHIH IKY Tl G1G Juu ----

Page 4

double-blind, randomized research (using the MECTA SR-1 and its predecessor the
MECTA Model D) demonstrated that the antidepressant effects of ECT are contingent
on the anatomic positioning of electrodes and the extent to which electrical stimulus
intensity exceeds seizure threshold (Sackeim et. al.,1987a; Sackeim et al., 1993). 7n other
words, the current paths traversed by the ECT stimulus and the current density within
these paths can profoundly influence antidepressant response . This work definitively
established that technical factors in ECT administration are fundamental in
determining the efficacy of the treatment- .An older literature compared ECT and
aittiaepressant medications in the treatment of major depression . While subject to a
number of methodologicL"qualifications, it is a fair statement that no study has ever
shown a pharmacological or other form of somatic treatment to be superior to ECT in
short-term antidepressant effects . The literature on the antidepressant efficacy of ECT
is critically reviewed in Sackeim (1989) and Sackeirn et al. (1995).

The most comprehensive review of the use of ECT in acute mania was published by
Mukherjee et al. (1994). It appears that approximately 80% of patients with acute
mania will experience marked improvement when treated with ECT. Randomized
controlled studies indicate that the therapeutic effects of ECT in acute mania are
equivalent or superior to those of some pharmacological alternatives (e.g., lithium
combined with antipsychotic) and superior to those of sham treatment (Mukherjee et
al., 1988; Small et al., 1988; Sikdar et al., 1994). In the case of patients in maru.c delirium
where the risk of death is extraordinarily high, use of ECT may be life saving,

The therapeutic role of ECT in the treatment of schizophrenia has been extensively
reviewed by Kt2teger and Sackeim (1995). In brief, relative to monotherapy with
traditional antipsychotic medication, ECT alone appears to be less efficacious .
However, there is a substantial literature that suggests that the combination of ECT
and antipsyrhotic medications may be more efficacious than either treatment alone,
particularly for patients with relatively short duration of illness or acute psychotic
exacerbation . A substantial case series literature suggests that ECT may be of value
when combined with antipsychotic medication when patients with schizophrenia
have manifested medication resistance, including patients who have failed the new
generation of atypical antipsychotics . Expert bodies have recommended that ECT be
particularly considered for medication resistant patients with schizophrenia' who
have prominent affective symptoms or catatonia (APA, ~1990).

Other than the possibility that the efficacy of ECT may be compromised by the use of
ultra-brief pulse widths (i.e ., < .1 ms) (Cronholm & Ottosson, 1963; Robin & de
Tissera , 1982), there is no evidence that the efficacy of ECT for any condition is
contingent on the ECT device that is used . Indeed, comparisons of an older
generation of devices that output an inefficient constant voltage sine wave stimulus
with constant current brief pulse stimulation failed to identify significant differences
in therapeutic properties (Valentine et al., 1968 ; Robin & de Tissera , 1982; Weiner et
al., 1986). A number of controlled trials and clinical series have been -reported with
the IvfECTA SRI or SR2 in the treatment of major depression and acute M,-nia (e.g .,
Iviukhe.rjee et al., 1988; Small et al., 1988; Sackeim et al., 1993; Beale et al., 1994; Lerer
JU:J-16-1997 18 :3.1 DEPT B I U r5 r-rt t rt [rc r

Page 5

et al., 1995). This work has been fundamental in certifying the efficacy of ECT in
these conditions and to document the specific therapeutic effects of these devices .

Side Effects of the Device -

ECT has the potential to result in a variety of medical complications, and in very
rare cases (estimated tc be 1 per 10,000 treatments) may result in death (Abrams,
1997). The most common form of medical morbidity, and mortality reflects
cardiovascular complications (Zielinski et al., 1993). The likelihood and nature of
these complications are strongly predicted by the medical status of the patient prior
to ECT. There is no evidence that the type of device used in ECT has impact on the
incidence or severity of medical morbidity or mortality . This is expected since the
medical complications associated with ECT almost all derive from physiological
consequences of seizure induction (e.g., hypertension secondary to catecholamine
release with a generalized seizure) and are independent of physical characteiistics of
the electrical stimulus .

The most common side effects of ECT are in the cognitive domain, and it is the
potenfral for adverse cognitive effects that limits the use of ECT. The nature of the
cognitive effects of ECT have been the subject of hundreds of investigations, and the
most detailed and recent investigations in this area have used the MBCTA SRI
(Sackeim et al., 1993; McElhiney et al., 1995; Sobin et al., 1995). The cognitive effects
of ECT have been extensively reviewed (Sackeim, 1992).

Briefly, the cognitive side effects of ECT display four key features. (1) Because there is
rapid recovery of cognitive functioning following a treatment session, the magrnitude
and nature of adverse cogrzitive side effects are contingent on the time of
examination. In general, cogrnitive side effects are most severe in the acute postictal
period, particularly at the end of the treatment course. (2) Methods of treatment
administration, including characteristics of the ECT stimulus, can have a profound
effect on the magnitude of short-term or transient cognitive side effects . In particular,
the use of sine wave relative to brief pulse stimulation (Weiner et al., 1986), high
intensity relative to low intensity electrical dosage (Sackeim et al., 1993), bilateral
relative to right unilateral electrode placement (Weiner et al., 1986; Sackeiun et al.,
1993), number and spacing of treatments (Lerer et a1.,1995) and other factors strongly
influence the magnitude and nature of cognitive side effects . (3) Independent of
treatment technique, there are individual differences in the magnitude and
persistence of adverse cognitive effects. It appears that patients with pre-existing
cognitive iznpairment znay be at greater risk for more extensive and persistent
retro;rade amnesia (Sobin et al., 1995). (4) The adverse cognitive effects of ECT are
highly stereotyped. Cognitive functions impaired by the psychiatric condition,
typically those dependent on the adequacy of attention and concentration, cornrnonly
show improvement within a few days of the ECT course, due to symptomatic
improvement. For example, general intelligence measures (IQ) typically improve
shortly following ECT (Sackeun et al., 1992). In contrast, ECT introduces deficits in the
capacity to retain newly learned information (rapid forgetting, anterooade amnesia),
and deficits in the capacity to remember events in the recent past (temporally-gzaded
JUN-16-1yYr :-52
la Lt-1 .olu i

Page 6

retrograde amnesia) . This pattern reflects a classic medial temporal lobe amnestic
syndroine (Sackeim & Stern, 1997). The anterograde amnesia resolves quickly
following termination of ECT, and after several weeks objective evidence of
difficulties in learning and remembering new information is not available (Sackeim,
1992; Sackeim et a1.,1993). Some patients may experience a permanent retrograde
amnesia,;with gaps in memory for events that occurred in the weeks to nwnths
surrounding the ECT course .

As indicated, the adverse cognitive side effects of ECT are partly coritingent on' the
characteristics of the ECT stimulus . The constant current brief pulse stimulus used
in the IvLECTA SR1/SR2 and JRl/JR2 models is associated with a superior cognitive
side effect profile relative to the stimulus administered by sine wave devices (e.g.,
Weiner et al., 1986) . Due to the capacity with these devices to carefully titrate
electrical intensity to the needs of individual patients (Sackeim et al., 1993; Bea1e et
al., 1994; Coffey et al., 1995), it has also been demonstrated that acute and short-term
cognitive side effects can be markedly reduced (Sackeim et a1.,1986,1993) .

Verification that the device achieves the performance intended by the

manufacturer and that it is suitable for its functions as a medical device
The MECTA SRI /SR2 and JR1/JR2 output the type of ECT stimulus that has been
strongly recommended by experts world-wide (APA, 1990; RCP, 1995). Theoretical
analysis of the physical characteristics of the ECT stimulus suggests that corn.stant
current brief pulse stimulation is optimal for ECT (Sackeim et al., 1994) . These
.
theoretical analyses are fully congruent with empiricial evideince indicating that this
form of stimulation is considerably more efficient in seizure-eliciting properties
(Weiner,1980; Sackeim et al., 1991) and results in less severe cognitive side effects
(Weiner et al, 1986) than sine wave stimulation .

I have had the opportunity to verify the accuracy of the P+MCTA SRl/SR2 stimulus
output characteristics, and other features of the stimulus delivery system (e.g.,
measurement of static impedance, calculation of delivered energy, voltage, dynarnic
impedance, etc.). The methods used to independently test a series of MECTA SRI
and SR2= devices have been published (Sackeim et al ., 1994). In brief, using custom
equipment, we have independently sampled the ECT stimulus administered in
over 2,000 treatments sessions of patients . To my knowledge, on no other occasion
has the stimulus actually administered to patients during ECT been. indepe:nden.tly
verified at this level of resolution. Sampling rate was 100,000 Hz for both current
and voltage, and the complete stimulus train was captured for off-line analysis .
This high resolution has allowed us to determine output accuracy within each pulse
of the delivered stimulus .

In my experience, the MECTA devices perform according to the manufacturer's

arid
claims- In particular, they are highly accurate in pulse frequency, pulse width,
train duration. I have never observed departures from expected values greater than.
2% . Ctirrent values (pulse amplitude) have shown gzeater variability across devices
(constant within a device) and have never deviated more than 7% from nominal
JUN-16-lyy'l lb ; .5 .5 Lcri DJU I ~~ ..., . 

7ZIV Page 7

values . Ms range of deviation is not meaningful in terms of clinical use of the

device. The fact that each of the devices allows for small increments in stimulus
intensity (e .g., 256 steps for the single dial SRZ and jR2) is critical in allowing
adjustment of the delivered charge to the needs of patients .

The SRl:/SR2 have the capacity for physiological monitoring, pr:widing two channel,
hard copy of EEG or EEG and ECG. On numerous occasions, I have verified
accuraory of amplifier output on these devices, using standard calibration techniques
with larn6wn signals that vary in frequency and amplitude. Of note, a variety of
studies have used the chart recorded representation of the EEG for manual iratings of
ECT seizures (Nob1eT et al., 1993) or have digitized the analog output of the SR1 / SR2
in quantitative studies of ECT seizure characteristics (Krystal et al. 1996). The fact that
reliable ratings have been obtained and consistent findings reaarding quantitative
EEG features also supports the adequacy of device performance for physiological
monitoring .

The design and construction of the IvIECTA SR1/SR2 and jR1/jR2 provide the
necessary and appropriate features for use in an ECT medical suite. Extensive use of
these devices here at Columbia University and by practitioners world-wide .,
underscores their suitability for ECT practice.

Risk-benefit analysis `
There are a variety of risks associated with administration of the electrical stimulus
in KT, the production of generalized seizures, and the adequacy of physiological
monitoring during the treatment .

Electrical safety. The electrical safety risks of ECT include the possibility of
electrical bums, improper grounding and passage of the ECT stimulus through the
patient's heart, and excessive electrical stimulation of the brain.

Burns. Electrical bums result from conditions of high voltage. With a

constant current ECT device, the impedance encountered during stimulus ;d.elivery
determines the voltage administered . . The MECTA SR1/SR2 and JRl/J1Z2 have two
provisions that radically reduce the possibility of electrode burns. First, before the
devices will arm, a self-test sequence must be passed (or deliberately by-passed) . The
self-test measures impedance in the circuit and will only pass if values are in the
range o.f 200-10,000 ohms. By determining the integrity of the circuit before arming,
the possibility of encountering high impedance is markedly reduced. A particular
feature is the detection of low impedance failures. When a conductive medium
bridges the two ECT electrodes (hair spray, electrode jell, etc.), impedance will be
very low . This circumstance will result in virtually all the current being shunted
between the electrodes through the scalp, without the intended seizure production,
and can also result in burns . The automatic detection of both excessively low and
high impedance is a safety feature of these devices . For these devices, a selftest
over-ride is useful in that very exceptional patients may have extremely low
impedance in the absence of improper electrode site preparation or other b:;~idasl .g
JUN-ib-lyy'1 1tf ; .5i Lcri DI

Page 8

problems. Of note, in my use of these devices, I have never encountered an

electrode burn, nor is there documentation of such a report in the literature . The
manuals for the MECTA devices describe accepted procedures for site preparation
and use of the self-test protection (Domestic Manual, page 22-33) .

' Ground faults. A requirement in ECT is that ECG be monitored, given that
cardiovascular complications are the greatest source of morbidity and mortality .
When an independent ECG device is used on a separate ground, and were a ground
fault to develop in the ECT device, there is the theoretical possibility of the ECT
electrical stimulus passing through the patient's heart. The intensity of the ECT
stimulus approaches that used in cardiac defibrillation . In line with expert body
recommendations (APA, 1990), the MECTA instruction manuals explicitly: :review
electrical dangers and steps to minimize risk (e .g., Domestic Manual, page 12) . The
grounding of the MECTA device should never be defeated, the grounding of other
electrical devices in contact with the patient should be verified, and all electrical
devices in contact with the patient should share the same ground. Other precautions
include ensuring that the ECT electrodes are only in contact with the patient and
flammable anesthetics are not used . In testing many MECTA devices, I have never
encountered a ground fault. I know of no instance world-wide where use of one of
these devices has resulted in morbidity or mortality due to electrical injury to a patient.

Electrical dosage. The third form of electrical risk concerns the administration
of excessive electrical dosage during ECT. Markedly exceeding the seizure threshold at
intensity levels beyond that needed to achieve clinical response may augment adverse
cognitivf! side effects (Sackeim, 1992) . The use of a constant current brief plilse
waveforzn by these devices introduces intrinsic safety features . First, the gxeater
efficiency of the brief pulse waveform relative to sine wave stimulation is essociated
with a superior profile of cognitive side effects (Weiner et al. 1986) . Second, the .. .
biological and behavioral effects of electrical brain stimulation is determined by
current or charge density (Sackeirn et a1.,1994) . The use of constant current brief
pulses that reach a maximum of only 800 mA provides intrinsic protection. The
maximum current density in neural tissue with these devices is at least an order of
magnitude below the threshold for tissue damage (Devanand et al., 1994). Third, with _
each of these devices the practitioner has a flexible means of individualizing the
delivered charge. Indeed, the instruction manuals for these devices describe two
different methods for individualizing the electrical dose (Domestic Manual pages 34-
39). While adverse cognitive side effects are an unavoidable consequence of ECT,
these devices are desibed to minimize such adverse effects . There is a substantial
empirical literature that supports this claim (Sackeixn et al., 1986, 1993).

A key issue in considering the clinical utility and safety of an ECT device i:~ the
maximal charge it can output and the gradations available to adjust the delivered
charoe to patient needs. The first generation of constant cvrzent brief puLse devices
produced by IvIECTA (Models C and D) were under powered, with a maximal charge
of A-48 mC and maximal energy of approximately 78 j (delivered into 220 ohm.s) .
lhere is remarkable variability among psychiatric patients in seizure thYeshold, the
JUN-16-1997 18 : .54 llEt'l t51u rr?I . . . . . . . . . .

Page 9

minimum charge needed to elicit an adequate generalized seizure . Work at

Columbia, now widely replicated world-wide, indicates that this range (with brief
pulse constant current stimulation) is in excess of 50-fold (Sackeim et al., 1987b, 1991,
1993) . Many patients will have adequate seizures at approximately 20 mC, and using
repeated empirical titration we have recently documented that some very exceptional
patients have thresholds in excess of 1,000 mC. Consequently, the experience with the
first generation of MECTA devices was that a substantial number of patients failed to
have the intended generalized seizure when rece> >ing maximal stimulation . This
would expose patients to the risks of general anesthesia and subconvulsive electrical
brain stimulation, without any possibility of therapeLtic benefit . Thus, practitioners
were often forced to use double stimulation, an intrinsically awkward technique, in
which a second electrical stimulus is given at a variable interval following the first
stimulus_ This method was not always effective, due to the interval required for
devices to re-arm, and was inherently imprecise in control over the administered
electrical dose . A related problem arose with the discovery that the extent to which
electrical dosage exceeds seizure threshold (in percentage terms) is a critical
determinant of the efficacy of the treatment (particularly when using the, right
unilateral electrode placement) and speed of response (regardless of the positioning of
electrodes) (Sackeim et al., 1987a, 1993). This discovery indicated that in patients with
high seizure threshold one could elicit generalized seizures at the rnaximal device
output that fully lacked therapeutic properties or that resulted in slow clinical
response due to insufficient charge in excess of threshold (APA,1990) . .

The initial versions of the MECTA SRl/SR2 and JRl/JR2 models attempted to
correct this problem by increasing maximal output to 576 mC or 101.4 J (delivered
into 220 ohms). However, the rapidly advancing information on the range in
human seizure threshold and the need to exceed the threshold by a substantial
amount (i.e., 150-450%) to ensure the efficacy of right unilateral ECT (which has a
superior side effect profile), led the clinical community to call for modifications to
these devices (Sackeim,1991) . Indeed, based on these considerations, the Royal
College of Psychiatrists Special Committee called for 1,200 mC being the minimum
maximal output of an ECT device (RCP, 1995). Modifications were then made to the
SR1/SR2 and JRl/JR2 models which can now reach 1,200 mC.

In research supported by the National Institute of Mental Health, I have used

MECTA SRI devices with this extended range since 1986 . We have documented
that some patients could not be effectively treated without this higher output range
(Sackeim,1991, Sackeim et a1.,1991, 1993; Lisanby et al ., 1996). Like our experience,
practitioners at other facilities in the U.S. and Europe report that a substantial
proportion of patients require an ECT dose between 600-1,200 mC.

1n determinTn g the electrical dose to be administered in ECT, two points are key.
First, with constant cuzz'ent brief pulse stimulation, the charge administered is of
consequence and not the energy. It is now widely accepted in ECT that the charge
administered (and consequently charge density in neural tissue) is iesponsi.ble for
neurobiological and behavioral effects (Sackeim et al., 1987c, 1994). Except for
Jl!N-16-199'l 1u ; .55 litri zsIu [ -11 ..- . . .  ,

Page 10

limiting the possibility of burns, the voltage administered with the constant c=ent
sdznulus~ (and consequently the energy) is largely irrelevant. Fortunately, with the
constant current devices, variations in the stimulus parameters directly alter the
delivered charge . The energy administered during the treatment cannot be known
beforehand, as it will depend on patient impedance. This consideration is relevant
to evaluating the size of the steps taken by the NLCTA devices in altering dosage .
When current (pulse amplitude) is increased, the size of steps will differ when
computed in units of charge and units of energy. The steps will appear larger in
units of energy due to the squaring of current values.

More 'critically, it is appropriate in ECT that the gradations of steps be larger at higher
absolute doses. Expert bodies generally concur that ideally the electrical dosage
administered in ECT should be a percentage multiple of the initial seizure threshold
determined at the first treatment (APA, .1990; RCP, 1995) . Furthennore, all,:
published methods of empirical dose titration, the most sensitive procedure to
quantify initial seizure threshold, use larger absolute size steps at the top of the
range (for patients with high thresholds) relative to the low end of the range
(Sackeirn et al'., 1987b ; Beale et a1.,1994; Coffey et a1.,1995) . This characteristic of ECT
reflects individual differences in extent of shunting of current away from brain .
Indeed, there is substantial evidence that dynamic impedance during passage of the
ECT stimulus (an indirect measure of shunting) and the minimum charge necessary
for seizure induction (an indirect measure of current density in brain) show a
substantial, inverse relationship (Sackeim et al., 1987c, 1994). Finer gradations at
low relative to high charge is theoretically and empirically justified and is reflected
in the IvIECTA SR1/SR2 and JRl/JR2 models. ;

Medical risks . The medical risks of ECT were summarized eariier . The
procedure is associated with a low rate of mortality. The rate of serious medical
complicitions with ECT is believed to be lower than with some accepted fo:i= of
pharmacological treatment, and patients with complicated medical conditions are often
preferentially referred for ECT (APA, 1990; Sackeim et al., 1995). There is no evidence
that the rates or nature of medical morbidity or mortality vary among ECT devices.

Physiological monitoring. Physiological monitoring of the

electrocardiogram (ECG) and the electroencephalogram (EEG) are strongly
encouraged in order to prevent or detect complications . Post-ictal arrythmias are
not uncommon in ECT and EEG monitoring is necessary to establish that seizures
have terminated (i.e., risk of nonconvulsive status epilepticus) . As indicated above,
clinical experience and the research literature both indicate that the monitoring
features of the SRl/SR2 devices are reliable and valid.

In summary, provision of ECT may have substantial benefit in terms of providing

improvement in the symptoms of specific psychiatric conditions . The efficacy of
ECT for specific conditions is well established, and in some instances, provision of
this treatment may be life saving
. Much of the modern evidence confiraning the
efficacy of ECT was obtained with Iv1ECTA SRI /SR2 or JR1/JR2 devices. Substantial
.JlrlYlU LJJI . , . __

Page 11

experience with these devices confirms their utility in clinical practice . With respect
to the risks of ECT, some classes of risk are independent of the ECT device used as
they are a consequence of seizure induction and not the methods used to induce the
seizure or to monitor physiological function . In the areas of electrical safety,
flexibility in determining electrical dosage, and physiological monitoring, the
MECTA devices are state-of-the-art and provide several safety features not found in
other devices. Consequently, the likely benefits of administering ECT -with these
devices outweigh the risks. .

Experience with the MECTA spECTrnm models. ,

I have had the opportunity to use a MECTA spECTrum 5000Q in the trea-tznent of
patients at the New York State Psychiatric Institute. I have also extensively tested
the reliability and accuracy of the stimulus output characteristics and the
physiological monitoring capabilities of the device. My view is that the spECTrum
models retain the benefits of fhe previous generation MECTA SR1/SR2 and JR1/JR2
models, but go beyond these devices in being safer and clinically more usefvl.

No difficulties were encountered in using a MECTA spECTrum 5000Q in routine

clinical care. Examination of the stimulus output characteristics indicated that
accuracy either equaled or exceeded that of MECTA SR1/SR2 models. Similarly, use
of known calibration signals verified the accuracy of spECTrum analog and digital
output for physiological monitoring.

There are several key advantages of the MECTA spECTrum over previous models .
The spECTrum provides continuous assessment of static impedance (integrity of the
circuit). MECTA SRI /SR2 and jR1/JR2 models required a deliberate self-test to arm
and the devices would stay armed for stimulus delivery until they were shut off.
Practitioiiers could avoid use of this safety precaution by leaving the device powered
up and not conducting the self-test procedure. The spECTrum provides accurate
and continuous values for static impedance, with a more conservative range for
armin g (100-5,000 ohms) than in the MBCTA SRI/SR2 and JR1./JR2 models (200-
10,000 ohms). Under conditions where the static impedance has increased from 800
to 3,000 ohms prior to stimulus delivery the prudent practitioner will now be aware
of this fact and can investigate the cause of this shift (most commonly poor contact
at the electrode/skin interface).

The spECTrum does not permit override in low or high static impedance conditions
and delivery of the stimulus is contingent on the static impedance reading once the
stimulus delivery button is depressed. By decreasing the low pass range to 100
ohms, the rare patients with intrinsically low static impedance are accommodated.
Impedance values below 100 ohrns should reflect a conductive bridge needing
correction . Similarly, I have never encountered a static impedance of 5,000 ohms or
greater that did not reflect lack of integrity of the circuit or poor site preparation . To
iny knowledge, the spECTrum is unique in requiring correction and preventing
stimulus delivery in these circumstances .
JI .IV-lO- .J-) 1
.
1 ~ 1V " JU - I -

Page 12

The spECTrum contains additional safety features that abort stimulus delivery
when voltage or energy thresholds are exceeded. Clinically, this would most likely
occur due to slippage of the electrodes during stimulus delivery, The optional hand
held electrodes are of superior design to previous models, providing greater
assurance that the operator cannot come in contact with the stimulating electrodes .
The computation of the delivered stimulus dosage characteristics is inherently .more
accurate with the spECTrum than the previous SRI/SR2 and JRl/JR2 models. The
spECTrum independently samples voltage and current and the computations reflect
what was delivered to the patient. In the SRl/SR2 and JRl/jR2 models, the'
computations of voltage and energy were partly based on assessments of the .
delivered stimulus, but the report of pulse width, frequency, duration and current
values only reflected the device settings, and not what was actually administered .
For example, premature release of the stimulus delivery button with the older
models could only be determined by noting the mismatch between the energy
calculation and what would be calculated based on the stated values for stimulus
parameters and voltage. The spECTrum provides accurate calculation, and
furthermore, warns the practitioner about instances of premature release .

The spECTrum models have greater flexibility in choice of stimulus parameters,

selectable through a menu system, while maintaining limits on the total charge and
energy that may be administered . This flexibility is important as there is active
investigation in the field of ECT regarding_ the relative efficiency of parameter
combinations (Sackeim et al., 1994). There are substantial reasons to suspect that
pulse widths of shorter duration (i.e., 0.5 rns) and trains of longer duration (i.e. > 2 s)
may produce seizures at lower total charge than other combinations . In turn, it is
likely that cognitive side effects may be reduced. By offering flexibility in choice of
parameter set, these devices are less likely to become obsolete with advances in the
field. Finally, the spECTrurn 5000 models offer options for additional channels of
physiological monitoring (EEG, ECG, and OMS), analysis of the EEG seizure
characteristics, and the option of monitoring multiple channels of physiology on a
remote computer screen and of saving in digital format the treatment parazn.ote}.-e '
and the physiological data. These features can only enhance the practice of ECT.

As I have indicated, the MECTA SRI /SR2 and JRl/JR2 models represented"an
advance for the field of ECT and their benefits outweigh their risks . In my view, the
spECTrum models represent a further advance that will further ensure sale and
effective practice of ECT.

Please feel free to contact me if additional information would be helpful .

 Page IQ

Nobler MS, Sackeim H.k, Solomou M, Luber B, Devanand DP, Prudic J: EEG
manifestations during ECT: effects of electrode placement and stimulus intensity .
Biol Psychiatry 1993;34:321-30 .

Prudic J, Haskett RF, lvlulsant B, Malone KM, Pettinati HM, Stepheris S, Greenberg
R, Rifas SL, Sackeim HA: Resistance to antidepressant medications and short-
term clinical response to ECTt Am J Psyc~iatry 1996;153 :985-92,

Robin A; de Tissera S: A double-blind controlled comparison of the therapeutic

effects of low and high energy electroconvulsive therapies. Br J Psychiatry
1982;141 :357-366 .

Royal College of Pyschiatrists . The ECT Handbook The Second .Report of the Royal
College of Psychiatrists' Special Committee on ECT. Council. Report CR39 . Londorn:
Royal College of Psychiatrists, 1995 .

SackPim HA: The efficacy of electroconvulsive therapy in treatment of major

depressive disorder, in Fisher S, Greenberg RP (ed): The Limits of Biological
Treatments for Psychological Distress : Comparisons with Psychotherapy and Placebo .
Hillsdale, NJ., Erlbaum,1989, pp. 275-307.

Sackeirn HA.: Are ECT devices underpowered? Convulsive Ther 1991;7:233-6 .

Sackeim HA: The cognitive effects of electroconvulsive therapy, in Moos tiYH,

Gamzu ER, Thal LJ (ed): Cognitive Disorders: Pathophysiology and Treatment. Ne-W
York, Marcel Dekker, 1992, pp. 183-228.

Sackeim HA., Portnoy S, Neeley P, Steif BL, Decina P, Malitz S: Cognitive

consequences of low-dosage electroconvulsive therapy. Ann N Y Acad Sci
1986;462:326-M0.

Sackeirn .HA., Decina P, Kanzler M, Kerr B, Malitz S: Effects of electrode placement

on the efficacy of titrated, low-dose ECT. Am J Psychiatry 1987a;144 :1449-55. .

Sackeim HA, Decina P, Prohovnik I, Malitz S: Seizure threshold in

electroconvulsive therapy. Effects of sex, age, electrode placement, and number of
treatnents. Arch Gen Psychiatry 1987b;44 :355-60.

Sackeim. HA, Decina P, Portnoy S, Neeley P, Malitz S: Studies of dosage, seizure

threshold, and seizure duration in ECT. Biol Psychiatry 1987c;22:249-268 .

Sackeim. HA, Devanand DP, Prudic J: Stimulus intensity, seizure threshold, and
seizu.re duration: impact on the efficacy and safety of electroconvuZsive therapy.
Psychiatr Clin North Am 1991 ;14 :803-43.

Sackeim HA, Freeman J, McElhiney M, Coleman E, Prudic J, Devanand DP : Effects oi

major depression on estimates of intelligence . J Clin Exp Neuropsychol 1992;1s:263-
88.

TOTi-il F, 'I .1
 Page 13

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Abrams R: Electroconvulsiae Therapy. New York,Oxford University Press, 1997.

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Sackeim HA, Small I]: The Practice of ECT: Recommendations for Treatment, Training
and Privileging. Washington, D.C .,.American Psychiatric Press, 1990 .

Beale MD, Kellner CH, Pritchett JT, Bernstein H, Burns CM, Knapp R: Stimulus
dose-titration in ECT: a 2-year clinical experience . Conauls Ther 1994;10 :171-6 .

Coffey CE, Lucke J, Weiner .RD, Krystal AD, Aque M: Seizure threshold in .
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CronhoJ.m B, Ottoson J-: Ultrabrief stimulus technique in electroconvulsive therapy .

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Devanand DP, Dwork Aj, Hutchinson ER, Bolwig TG, Sackeim HA: Does
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SR, Weinberar D (ed): Schizophrenia. Oxford, Blac_kwe11,1995, pp. 503-54.5.

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Lerer B, Shapira B, Calev A, Tubi N, Drexler H, Kincller S, Lidsky D, Schwartz JE:

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Lisanby SH, Devanand DP, Nobler MS, Prudic j, Mullen L, and Sackeim HA:
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McElhiney MC, Moody Bj, Steif BL, Pru.dic J, Devanand DP, Nobler MS, Sackeinm
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Neuropsychology 1995;9 :501-517.

Mukherjee S, Sackeim HA, Schnur DB: Electroconvulsive therapy of acute Manic

episodes: a review of 50 years' experience . Am J Psychiatry 1994;151:169-76.

Mukherjee S, Sackeim HA, LeQ C: Unilateral ECT in the treatment of maznic

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