Cortical Stimulator
S12X CORTICAL STIMULATOR

NEWConstant Current, Bi-phasic Stimulator

From the world renowned manufacturer of research stimulators, the new Grass S12X Cortical Stimulator is FDA listed for clinical use. The S12X is a constant current,
bi-phasic stimulator intended for cortical stimulation mapping to aid in cortical resection procedures. Stimulation can be via a traditional hand-held electrode probe for intraoperative stimulation, or via intracranial electrodes using the Grass ESAx Electrode Switching Array option in conjunction with Grass Technologies’ Beehive Video/EEG monitoring systems. Using the S12X touch-panel screen, the user can select any of up to 128 electrodes for delivery of stimulation pulses.

Cortical Stimulator Features:
Bi-phasic, Constant Current stimulation up to 15 mA
Real-time display of delivered current, measured voltage, and electrode impedance
Intuitive Touch-screen LCD Display, including on-screen electrode selection
Direct Connect up to 128 channels for electrode selection and EEG recording
Import electrode names from Beehive TWin recording montages
Logging of stimulation parameters to a text file for record keeping
Hand-held controller for remote start/stop stimulation controls
•   Inherent safety/shutdown features to prevent over stimulation

The ESAx Electrode Switching Array interfaces to the S12X output for delivery of stimulation pulses via intracranial electrodes. The ESAx has appropriate connectors for connecting EEG electrode jack boxes and EEG Amplifiers (Grass Technologies’ CTE, AURA, or AURA-LTM64 amplifiers). Each ESAx handles 64 channels.

Electrode Switching Array Features:
Optical relays powered by the isolated power supply of the S12X
Electrodes for stimulation are selected on the S12X touch-panel display
ESAx connects any combination of 64 electrodes to the plus and minus stimulus output of the S12X
ESAx disconnects the EEG amplifiers associated with the selected electrodes to ensure all current is delivered to the electrodes, to prevent saturation of amplifiers, and for faster amplifier (EEG) recovery when the stimulation train stops
Two ESAx switching units can be daisy chained for up to 128 channels

When using the S12X Stimulator with the ESAx option, all of the patient’s electrodes and the Beehive recording system’s amplifiers remain connected, and EEG waveforms are displayed and recorded. Once electrodes are selected on the S12X electrode selection touch-screen, the Channel Check function can be activated. During channel check a “buzz” signal is introduced into the EEG amplifiers corresponding to the electrodes selected. This provides a visual verification of selected channels on the EEG waveform display. Stimulation pulses can then be delivered to the selected electrodes.

SPECIFICATIONS
Stimulation Waveform
Pulse Type   Constant current, bi-phasic
Pulse Amplitude   0.2 to 15 mA in 17 steps with fine adjustment, except at 2000 µsec when current is limited to 10 mA
Amplitude Accuracy   5% or 0.02 mA, whichever is greater
Pulse Duration   0.1 to 2.0 msec in 7 steps
Frequency Range   2 to 100 Hz in 7 steps, except at pulse widths of 1000 or 2000 µsec when the frequency is limited to 50 Hz
Time Base Accuracy   0.01% or pulse width,
0.1% for repetition rate
Load Impedance   Maintain current accuracy from 100 to 2000 ohms
Leading Pulse Polarity   Selectable positive, negative, or alternating on successive pulses
Maximum Slew   30 µsec (measures less than 20 µsec)
Maximum Droop   5% of selectable amplitude
Train Duration   0.2 to 20 sec in 7 steps
Power   Medical Grade Isolated Power Supply
Physical Size   13.25" W x 6.5" H x 7" D
(33.7 cm x 16.5 cm x 17.8 cm)
Weight   5 lbs. (2.25 kg)
Regulatory   CE mark pending
SPECIFICATIONS
Additional Features
Impedance Test   Checks load impedance
Isolated Power Out   Special connection, only for use with Grass Technologies ESAx Electrode Switch Array Option
ESAx Specifications
Channels per ESAx   64
Maximum Number
of ESAx per S12X
  2
Power   Isolated low voltage 5 VDC supplied by S12X
Physical Size   1” H x 8.5” W x 6.5” D
(2.54 cm x 21.6 cm x 16.5 cm)
Weight   1 lb. 10 oz. (0.74 kg)
Manual Probe Option
Probe Length   5” (13 cm)
Probe Construction   Delrin, covered with Polyolefin tubing
Probe Cable   Twisted pair, 12 feet (3.6 m)
Electrode Construction   2 mm diameter, polished, gold-plated balls
Electrode Gap   5 mm (adjustable)

ORDERING INFORMATION
Model S12X
 

Stimulator including manual and power supply

Options:
Model ESAx-1   Electrode Switch Array supports channels 1-64
Model ESAx-2   Electrode Switch Array supports channels 65-128
Model F-BSE1   Manual Probe
Specifications subject to change without notice


S12X Cortical Stimulator


ESAx Electrode Switching Array

S12X Touch Screen main display, with:
• Touch pads and pull down menus for selection of pulse parameters
• Real-time display of stimulation current, voltage, and electrode impedance
• Calibration of S12X by delivering current to an internal 1,000 Ohm dummy load
• Activate “Channel Check” function

Electrode selection screen, with:
• Touch pads for selection of electrodes for connecting to the plus and minus outputs of S12X
• Multiple electrodes can be selected for connecting to plus and minus
• Import electrode lists and names as programmed on the Beehive recording system
• Select from up to 128 electrodes
• Stimulation details and parameters are saved to a log text file

Channel Check function activated. In the example above, G05 and G15 electrodes are selected for stimulation. A “buzz” signal is shown in the corresponding EEG channels on the Beehive waveform display.

When stimulation is initiated, the selected electrodes are connected to the S12X (G05 and G15 in this example) and the corresponding EEG amplifiers are disconnected. At the end of the stimulation train, the amplifiers and electrodes are reconnected, and EEG recording for those channels resumes. Other electrodes and amplifiers remain connected at all times.

Caution: Federal Law (U.S.A.) restricts these devices to sale by or the order of a physician.
Caution: It is strongly recommended that users be trained in the functional use of the S12X Cortical Stimulator and the ESAx switch box prior to initial use.
Caution: When in use, the S12X Cortical Stimulator must be attended at all times by medical professional trained in cortical stimulation.
Warning: When using grid or strip electrodes, it is recommended that an image scan be performed to confirm the electrodes are anatomically positioned properly on the patient.
Warning: The S12X Cortical Stimulator and ESAx option should only be used with grid, strip, and depth cortical electrodes that are FDA cleared for stimulation AND recording.
Warning: Electrodes used with the S12X and ESAx option should use lead wires terminating in FDA mandated, female touch proof safety 1.5mm sockets.