The Intelect® Legend Stim, available in models 2S and 4S, is a multi-waveform electrotherapy system designed for pain management and muscle contraction therapy. It is a prescription device intended for use under the supervision or order of a physician or licensed healthcare provider. The device incorporates user-friendly 1-2-Go software, a clear backlit LCD display, and programmable power-up presets to enhance ease of use and efficiency.

Function Description

The Intelect® Legend Stim delivers various electrical stimulation waveforms for therapeutic purposes. Its primary functions include:

Pain Management: The device offers two main waveforms for pain management: Interferential and Premodulated.
- Interferential: This waveform utilizes two channels, each with a sinusoidal waveform, one fixed and one variable in frequency. When four electrodes are positioned to cross each other, the waveforms mix within the tissue, producing a train of pulses. The frequencies and amplitude of these pulses are determined by the sweep mode, beat frequency, and amplitude settings. The "Ch. Select" function allows for amplitude setting, with options for "Both Channels" (equal intensity change), "Channel 1" (changes only channel one), and "Channel 2" (changes only channel two), which is useful for balancing output. Amplitude Modulation offers "40% Scan" (default), "100% Scan," and "Static" (no scan). Scan Percentage indicates the decrease from maximum amplitude, creating a perceived movement of the Interferential field. Beat Frequency options include 1-10 Hz, 80-150 Hz (default), 1-150 Hz, Variable, and Fixed. The Variable option allows selection of a Low Beat frequency (1-200 Hz) and a High Beat frequency (1-200 Hz), defining the lowest and highest frequencies in a sweep mode, respectively. The Fixed Option allows for a single fixed frequency from 1-200 Hz.
- Premodulated: This is an amplitude-modulated sine wave, similar to the beat frequency of Interferential current. It serves as an alternative to Interferential treatment, particularly when four electrodes cannot be easily utilized on a body area. The "Cycle Time" parameter controls the on/off cycle time of the current, with "Continuous" (default) and "5/5" options. Similar to Interferential, "Beat Frequency" offers 1-10 Hz, 80-150 Hz (default), 1-150 Hz, Variable, and Fixed options, allowing for selection of Low Beat and High Beat frequencies within a sweep mode or a single fixed frequency.
Muscle Contraction Therapy: The device provides two waveforms for muscle contraction: Twin-Peak High Volt and Russian. These are used for relaxing muscle spasms, increasing local circulation, re-educating atrophied muscles, and maintaining or improving joint range of motion.
- High Volt: This stimulation delivers very short-duration pulses with low pulse charge, with output ranges between 300 and 500 volts. High Volt is available on channel 2 (2S and 4S models) and channel 4 (4S model). The "Method" setting allows for delivery via "Pads" (default) or "Probe" application. "Polarity" of the active electrode can be changed between "Positive" (default) and "Negative." The "Cycle Time" parameter controls the on/off cycle time, with options like 5/5, 10/10, 10/20, 4/12, 10/30, 10/50, and "Continuous" (default). "Sweep" refers to frequency modulation, with options including "Continuous" (default at 100 pps), 1-10 Hz, 80-150 Hz, and 1-150 Hz. "Frequency" allows adjustment of pulses per second from 1-120 pps. "Ramp" controls the time to reach selected amplitude (0.5, 1, 2 (default), or 5 seconds). "Display" offers viewing output as "Voltage" (default) or "Peak Current" to assess tissue response and impedance.
- Russian: This waveform uses a 2,500 Hz sinusoidal carrier wave, interrupted to create pulse trains or "bursts." The number of bursts per second is determined by the burst frequency, and burst length by the duty cycle. "Mode" provides "Single channel application," "Reciprocal application" (alternating stimulation between agonists and antagonists), and "Co-Contract" (coordinated timing for simultaneous co-contraction). "Cycle Time" options are similar to High Volt: 5/5, 10/10, 10/20, 4/12, 10/30, 10/50 (default), and "Continuous." "Burst Frequency" ranges from 20 to 100 bps. "Ramp" controls the time to reach selected amplitude (0.5, 1, 2 (default), or 5 seconds). "Duty Cycle" is the ratio of on time to total burst time, expressed as a percentage, with options of 10%, 20%, 30%, 40%, and 50% (default).

Usage Features

The Intelect® Legend Stim is designed for intuitive operation:

Operator Interface:
- Model 2S: Features a Liquid Crystal Display (LCD).
- Model 4S: Features an LCD and three Light Emitting Diodes (LEDs) to display Channel designation, Treatment time, and Output, while parameter options are viewed on the LCD.
Software Control: The software is user-friendly, allowing users to select a treatment mode, increase intensity, and press "Start" to begin.
Changing Parameters: Parameters can be changed using "UP/DOWN" arrows to select, and "ENTER" to confirm. For two options, "ENTER" toggles between them. For three or more, "ENTER" displays a pop-up window, where "UP/DOWN" arrows select an option, and "ENTER" accepts it.
Navigation Buttons:
- Enter: Controls the "Select Highlight" box and confirms changes.
- Main Menu/Escape (4S only): Returns to the Main Menu or exits a pop-up menu.
- Channel (2S only): Changes parameter display between Channel 1 and Channel 2.
- Time: "UP/DOWN" arrows increase or decrease the default treatment time.
- Power/Intensity: "UP/DOWN" arrows increase or decrease the intensity/power.
- Treatment Selection: Buttons for Interferential, Premodulated, High Volt, Russian, Ultrasound, and Combo.
- Start: Initiates treatment on the selected channel.
- Stop: Halts treatment on the selected channel.
- Pause: Temporarily suspends treatment on the selected channel.
Operating Channels: Model 2S provides two channels, while Model 4S provides four channels for electrical stimulation.
Stimulation Output Channels: These ports are where the lead wires connect.
Hand-Held Probe (Optional): The High Volt probe allows for manual stimulation delivery. The Black lead wire connects to the probe, and the Red lead wire attaches to an electrode placed near the treatment site. Default polarity for High Volt is positive (Red lead positive, Black lead negative). If "Negative Polarity" is selected, the Red lead becomes negative and the Black lead becomes positive.
Presets: Users can select and modify desired parameters, then press and hold the "PAUSE" button, followed by the "ENTER" button, to save them as presets.
LCD Screen Contrast: Contrast can be adjusted by pressing and holding the "MAIN MENU" button and using the "POWER/INTENSITY" buttons.

Maintenance Features

The device requires minimal user maintenance, with emphasis on cleaning and regular checks for proper operation:

User Maintenance:
- Cleaning: Turn off and unplug the unit before cleaning. Use a damp cloth with a small amount of mild household detergent if desired. Avoid abrasive cleaners.
- Between Patient Uses: Patient-applied parts should be wiped clean with a damp cloth, then cleaned with a hospital-grade germicide, following the manufacturer's directions. Highly concentrated germicide mixtures should be avoided as they may damage the product.
Technical Maintenance:
- Disassembly and Repairs: No attempt should be made to disassemble the unit by unauthorized personnel. All maintenance and repairs must be performed by authorized personnel.
- Recalibration: To maintain compliance with Federal Regulation Title 21 (21 CFR), the unit must be recalibrated annually. It is recommended that all Chattanooga Group ultrasound products be returned to the factory or an authorized servicing dealer for repairs or recalibration, especially after the replacement or repair of any major component.
- Monthly Checks:
  - Power Cord and Plug: Check for fraying, kinking, or torn/cut insulation.
  - Lead Wires: Check for fraying, kinking, or torn/cut insulation.

Intelect LEGEND Series - Page 27

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