The device described in this manual is the Soterix Medical 1x1 Low-Intensity Transcranial Electrical Stimulator, Model 2001 (1x1 tES). It is an investigational device designed for transcranial electrical stimulation (tES), a non-invasive technique that sends small currents across the scalp to modulate brain function. The device generates an electrical field in the brain that modulates brain function according to the modality of the application. It can deliver various stimulation types, including direct current (transcranial Direct Current Stimulation, tDCS), pulsed (transcranial Pulsed Current Stimulation, tPCS), alternating (transcranial Alternating Current Stimulation, tACS), random noise (transcranial Random Noise Stimulation, tRNS), or oscillating direct (transcranial Oscillating Direct Current Stimulation, tODCS). For tDCS, a small current passes from the positive electrode (anode) to the negative electrode (cathode), increasing the activity of the brain near the anode and decreasing activity near the cathode. For tPCS, tACS, tRNS, and tODCS, electrode polarity is not an issue as current reverses its direction at regular intervals.
Function Description:
The 1x1 tES device is designed to deliver low levels of current between electrodes placed on the body, specifically the scalp, to modulate brain activity. The device allows for various stimulation waveforms (tDCS, tPCS, tACS, tRNS, tODCS), frequencies, durations, and intensities. The anode is the positive electrode from which current enters the body, while the cathode is the negative electrode from which current exits the body and returns to the device. The device aims to induce reversible changes in cortical plasticity.
Key Features:
- Multiple Stimulation Modes: Supports tDCS, tPCS, tACS, tRNS, and tODCS, offering flexibility for different research protocols.
- Adjustable Parameters: Allows adjustment of frequency (up to 200 Hz with 0.5 Hz resolution), duration (up to 40 minutes), and current intensity (up to ±2,000 µA).
- TRUE CURRENT™ Display: This display is active whenever the device is on and indicates the actual value of current (in mA) being supplied by the device to the electrodes. For tDCS, tPCS, tACS, and tODCS, the TRUE CURRENT™ indicates the maximum value the waveform is able to reach. For tRNS, the TRUE CURRENT™ feature is disabled as current intensity values are randomly generated.
- SMARTscan-ES™ Feature: Provides a constant display of electrode contact quality before, during, and after stimulation. It indicates the level of contact quality (from 1 to 10, with 10 being the best) and is crucial for ensuring safe and effective stimulation. The SMARTscan-ES™ indicator is not available during stimulation for tRNS.
- RELAX Slider: Allows the operator to decrease the set level of current from the maximum (FULL CURRENT) value. The RELAX slider indicates the reduced current value and does not affect the duration of stimulation. It is used to accommodate individual subject's sensation by moving the RELAX slider down away from FULL CURRENT.
- PRE-STIM TICKLE: When activated, this feature delivers an approximately 30-second, 1 mA current to condition the electrodes, skin, or subject before the main stimulation.
- SHAM Mode: The device can be set to a SHAM mode, which simulates the experience of stimulation without delivering a full current, often used in control groups for blinding purposes.
- Safety Features: Includes warnings for improper battery direction, depleted batteries, and cautions against using the device if the subject is connected to other electrical devices or if the power is on or off is not recommended. It also warns against tampering with the placement of the sponges during tES.
- User-Friendly Interface: The front panel includes clearly labeled buttons and displays for easy operation and monitoring of stimulation parameters.
Important Technical Specifications:
- Power Source: 2, 9V Alkaline batteries (with fresh batteries, 3 hours** runtime).
- Standard Modes: 5 modes –DC (tDCS and tODCS) and non-DC (tPCS, tACS, tRNS).
- Adjustable Frequencies: Up to 200 Hz with 0.5 Hz resolution.
- Adjustable Duration: Up to 40 minutes.
- Adjustable Current Intensity: Up to ±2,000 µA.
- Length: 7.91 in.
- Width: 5.9 in.
- Height: 2.83 in.
- Connector Type: Shielded banana.
- Maximum Output Voltage: 40V ± 2V.
Storage and Operating Conditions:
| Parameter |
Storage |
Operating |
| Minimum temperature |
50° F |
50° F |
| Maximum temperature |
110° F |
110° F |
| Minimum humidity |
20% |
20% |
| Maximum humidity |
90% |
90% |
| Minimum atmospheric pressure |
20.7 in. Hg (700 hPa) |
20.7 in. Hg (700 hPa) |
| Maximum atmospheric pressure |
31.3 in. Hg (1060 hPa) |
31.3 in. Hg (1060 hPa) |
Usage Features:
- Battery Insertion: The device operates on two 9V alkaline batteries. Users must ensure correct battery polarity when inserting them.
- Electrode Preparation: Sponges (5x7 cm or 5x5 cm) should be soaked with saline solution (6 mL for 5x5 cm, 12 mL for 5x7 cm) and placed into the carbon-rubber electrode inserts.
- Electrode Placement: Electrodes are applied to the treatment site, ensuring good contact with the skin.
- Stimulation Procedure:
- Turn on the POWER switch.
- Set the desired WAVEFORM, FREQUENCY, DURATION, INTENSITY, and POLARITY.
- Optionally, use the PRE-STIM TICKLE button.
- Press the START button to begin stimulation.
- Monitor the TRUE CURRENT™ and SMARTscan-ES™ displays.
- Adjust the RELAX slider if needed for subject comfort.
- The TIME REMAINING display will show the remaining stimulation time.
- The stimulation ACTIVE light will flash for the first 30 seconds as current ramps up.
- The stimulation will automatically stop at the end of the set duration.
- Ramp-up/Ramp-down: Current ramps up in 30 seconds and ramps down in 30 seconds for most waveforms (tDCS, tPCS, tACS, tRNS, tODCS). Active tDCS (or SHAM OFF) waveform is shown below.
- Figure 1: Active tDCS waveform shows a ramp-up (approx. 30 seconds) to a set intensity, maintained for the duration, followed by a ramp-down (approx. 30 seconds).
- Figure 2: Active tPCS, tACS, tRNS waveforms are depicted as bipolar.
- Figure 3: Active tODCS waveforms are generated from unipolar versions of Figure 2: Pulsed (left), Sine (middle), and Random Noise (right).
- Figure 4: Sham tDCS waveform shows a brief ramp-up and ramp-down at the beginning and end of the stimulation, with no current delivered during the main duration.
- Safety Precautions: Users are warned against immersing the device in water, using it in a moist environment, or near flammable anesthetic mixtures. It should not be used with other implanted or external electrical stimulation devices. Cables should be connected properly, and skin irritation should be monitored.
Maintenance Features:
- Cleaning: The device should be cleaned with a dry cloth. Do not spray liquid cleaners directly on the device.
- Disinfection: Do not disinfect the device.
- Storage: Store the device in a dry place, away from water.
- Battery Replacement: Batteries should be replaced every 3 hours of use or when the low battery indicator is illuminated. Do not use abrasive cleaners on battery contacts.
- Disposal: Dispose of depleted batteries in accordance with local regulations. The device itself should be disposed of in generic waste after use.
- Warranty: Soterix Medical offers a limited warranty for the device, covering defects in materials and workmanship for one year. The warranty does not apply to misuse, abuse, accident, or modifications.
- Service: For warranty service, the equipment should be returned to Soterix Medical.
- Electrode Care: Sponges should be replaced regularly to ensure optimal contact quality and prevent irritation. Do not reuse sponges.
Classifications:
- In accordance with IEC 60601-1:
- Internally powered equipment
- Type BF equipment
- Continuous operation according to the mode of the operation
- Portable equipment
- In accordance with EU Medical Device Directive:
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