Chattanooga Group INTELECT LEGEND Series - User Manual

User Manual
COMBO
INTELECT
®
LEGEND
SERIES
Models 2C & 4C
ISO 13485 CERTIFIED

Summary

Foreword

Product Description

Precautionary Instructions

General Safety Warnings

Important cautions, warnings, and precautions for device operation.

Installation and Package Contents

Initial Setup Instructions

Steps for initial setup and connecting the unit to power.

Standard Accessories Included

List of accessories supplied with the Intelect Legend Combo unit.

Optional Accessories

Electrical Stimulation Safety and Indications

Interferential and Premodulated Information

Indications and contraindications for Interferential and Premodulated waveforms.

Russian and High Volt Indications

Indications for using Russian and High Volt stimulation modes.

General Stimulation Safety Precautions

General warnings and precautions for electrical stimulation use.

Specific Stimulation Warnings and Contraindications

Specific warnings and contraindications for Russian and High Volt modes.

Specific Precautions and Adverse Effects

Adverse Effects and Special Conditions

Precautions for specific conditions and reported adverse effects.

High Volt Probe Operation

Instructions for using the optional High Volt probe.

Maintenance Procedures

User Maintenance Guidelines

Guidelines for cleaning and maintaining the unit between patient uses.

Technical Maintenance Checks

Regular checks for power cord, cables, and sound head condition.

Unit Overview and Controls

Operator Interface Explained

Description of the LCD display and LED indicators on the unit.

Control Panel Navigation and Parameters

How to adjust parameters and navigate the control panel.

Treatment Execution and Ports

Using treatment controls and understanding device ports.

Pain Management Therapies

Interferential Waveform Operation

Parameters and operation of the Interferential waveform.

Amplitude Modulation and Scan

Settings for Amplitude Modulation and Scan Percentage in IFC.

Beat Frequency Settings

Configuring Beat Frequency options: Variable and Fixed.

Premodulated Waveform

Cycle Time and Beat Frequency Adjustment

Setting Cycle Time and Beat Frequency for Premodulated therapy.

Muscle Contraction Therapies

High Volt Waveform Details

Parameters for High Volt stimulation: Method, Polarity, Cycle Time.

High Volt and Russian Parameters

Adjusting Frequency, Ramp, and Russian waveform settings.

Russian Waveform Operation

Parameters and modes for Russian stimulation.

Ultrasound Indications and Contraindications

Ultrasound Therapy Indications

Medical conditions suitable for Ultrasound treatment.

Ultrasound Therapy Contraindications

Conditions and patient types where Ultrasound therapy is contraindicated.

Ultrasound Operation

Ultrasound Frequency and Duty Cycle

Adjusting Ultrasound frequency and duty cycle for therapeutic effect.

Ultrasonic Power and Display Options

Settings for ultrasonic power output and display modes.

Head Warming Feature

Description of the Head Warming function for enhanced comfort.

Combination Therapy

Combination Therapy Setup

Step-by-step instructions for setting up Combination mode therapy.

Switching Between Modes

Procedure to switch between Ultrasound and Stimulator screens.

Combination Mode Waveforms

Available waveform options within Combination mode.

Miscellaneous Operations

Changing Presets and Contrast

Procedures for modifying presets and adjusting LCD screen contrast.

Technical Specifications - Stimulator

Interferential and Premodulated Specs

Technical output parameters for Interferential and Premodulated waveforms.

Technical Specifications - Stimulator Continued

Russian and High Volt Specs

Technical output parameters for Russian and High Volt waveforms.

Technical Specifications - Ultrasound

Ultrasound Parameters

Detailed technical specifications for Ultrasound frequency, power, and beam.

Product Warranty

Warranty Coverage and Exclusions

Details on product warranty period and items not covered.

Obtaining Service and Legal Disclaimer

Warranty Service Procedure

Steps required to obtain warranty service for the product.

Additional Chattanooga Group Products

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Intelect® Legend Combo, available in models 2C and 4C, is a versatile medical device designed for physical therapy applications, combining both electrical stimulation and ultrasound therapies in a single unit. It is a prescription device intended for use under the supervision or order of a physician or other licensed healthcare provider.

Function Description

The device serves as a full-featured stimulator and ultrasound unit. It offers a range of electrical stimulation waveforms, including Interferential, Premodulated, High Volt, and Russian, to address various therapeutic needs. The ultrasound component features dual-frequency capabilities, delivering either 1 or 3.3 MHz frequencies, with selectable duty cycles (10%, 20%, 50%, and continuous). A unique "Electronic Signature™" control allows for the interchangeability of all available ultrasound applicators, ensuring accurate calibration. The unit can operate ultrasound independently or in combination with Interferential, Premodulated, and High Volt waveforms.

Electrical Stimulation: The electrical stimulation modalities are primarily used for pain management and muscle contraction therapy.

• Interferential (IFC) and Premodulated: These waveforms are indicated for the symptomatic relief of chronic, intractable pain and the management of pain associated with post-traumatic or postoperative conditions. IFC uses two channels with sinusoidal waveforms that cross each other in the tissue, producing a train of pulses. Premodulated therapy is an amplitude-modulated sine wave, similar to the beat frequency of IFC, and can be an alternative when four electrodes cannot be utilized.
• High Volt and Russian: These waveforms are used for muscle contraction therapy, including relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and muscle re-education. High Volt stimulation delivers short-duration pulses with very low pulse charge, with output ranges between 300 and 500 volts. The Russian current is a 2,500 Hz sinusoidal carrier wave interrupted to create pulse trains or "bursts."

Ultrasound Therapy: Ultrasound therapy applies deep heat to tissues, which can be used for the treatment of selected medical conditions such as the relief of pain, muscle spasms, and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, and soft tissue injuries. The device can provide therapeutic deep heating between 40 and 45°C in all operating modes.

Combination Therapy: In combination mode, ultrasound therapy is integrated with Interferential, Premodulated, or High Volt electrical stimulation. The aluminum face of the ultrasound applicator acts as one half of the electrical circuit, with an electrode completing the circuit. This mode is particularly useful for applications like the reduction of muscle spasm.

Usage Features

The Intelect® Legend Combo is designed for user-friendly operation, featuring "1-2-Go" software. The operator interface includes a Liquid Crystal Display (LCD) and three Light Emitting Diodes (LEDs) to show channel designation, treatment time, and output. Parameter options are displayed on the LCD.

Control Panel: The control panel features dedicated buttons for each treatment mode (IFC, PREMOD, HIVOLT, RUSSIAN, US, COMBO), along with general control buttons:

• Enter: Confirms selections and toggles between options.
• Main Menu/Escape: Returns to the main menu or exits pop-up menus.
• Time: Adjusts the default treatment time using UP/DOWN arrows.
• Power/Intensity: Increases or decreases intensity/power using UP/DOWN arrows.
• Start: Initiates treatment on the selected channel.
• Stop: Terminates treatment.
• Pause: Temporarily halts treatment.
• UP/DOWN Arrows: Used to select parameters, adjust values, and navigate menus.

Parameter Adjustment: To change parameters, users select the desired parameter with UP/DOWN arrows and press ENTER. For options with multiple choices, a pop-up window appears, allowing selection with UP/DOWN arrows and confirmation with ENTER.

Specific Modality Features:

• Interferential:
  • Ch. Select: Controls amplitude setting (Both Channels, Channel 1, Channel 2) for balanced output.
  • Amplitude Modulation: Options include 40% Scan (default), 100% Scan, and Static (no scan), which describe the percentage of decrease from maximum amplitude and the rhythmical varying of the amplitude.
  • Beat Frequency: Offers 1-10 Hz, 80-150 Hz (default), 1-150 Hz, Variable, and Fixed options. Variable allows selection of Low and High Beat frequencies (1-200 Hz), while Fixed allows a single frequency (1-200 Hz).
• Premodulated:
  • Cycle Time: Controls on/off cycle time of the current, with options like Continuous (default) and 5/5.
  • Beat Frequency: Similar options to Interferential (1-10 Hz, 80-150 Hz default, 1-150 Hz, Variable, Fixed).
• High Volt:
  • Method: Allows delivery via Pads (default) or Probe.
  • Polarity: Active electrode polarity can be changed from Positive (default) to Negative. Red lead wire is positive for Positive polarity and negative for Negative polarity.
  • Cycle Time: Offers 7 options for on/off cycle time (e.g., 5/5, 10/10, Continuous default).
  • Sweep: Frequency modulation with options like Continuous (default at 100 pps), 1-10 Hz, 80-150 Hz, and 1-150 Hz. Continuous allows fixed frequency from 1-120 pps.
  • Ramp: Controls the time to reach selected amplitude (0.5, 1, 2 default, 5 seconds).
  • Display: View output in Voltage (default) or Peak Current.
• Russian:
  • Mode: Three treatment methods: Single channel, Reciprocal (alternating stimulation between agonists and antagonists), and Co-Contract (coordinated stimulation through two channels).
  • Cycle Time: 7 options for on/off cycle time (e.g., 5/5, 10/10, 10/50 default, Continuous).
  • Burst Frequency: Number of bursts per second (20-100 bps).
  • Ramp: Time to reach selected amplitude (0.5, 1, 2 default, 5 seconds).
  • Duty Cycle: Ratio of on time to total burst time (10%, 20%, 30%, 40%, 50% default).
• Ultrasound:
  • Head Warming: Unique feature to warm the aluminum surface of the applicator to room temperature for patient comfort.
  • Frequency: Selectable between 1 MHz and 3.3 MHz, determining depth of penetration.
  • Duty Cycle: Ratio of on time to total time (10%, 20%, 50%, 100% continuous default).
  • Display: Shows output in Watts or Watts Per Square Centimeter.
• Combination Therapy:
  • Step-by-step instructions: Select Combo, set ultrasound intensity, press Enter, set stimulation intensity, press Start.
  • Switching between US and Stim parameters: Press Enter when Channel Select is highlighted to switch to waveform parameters.
  • Mode: Displays Interferential, Premod, and High Volt (default) waveform options.

Miscellaneous Features:

• Changing Presets: Select and modify desired parameters, then press and hold PAUSE, followed by ENTER.
• Changing LCD Screen Contrast: Press and hold MAIN MENU, then use POWER/INTENSITY buttons to adjust contrast.

Maintenance Features

The Intelect® Legend Combo requires both user and technical maintenance to ensure proper operation and longevity.

User Maintenance:

• Cleaning: Turn off and unplug the unit. Clean with a damp cloth and mild household detergent. Between patient uses, patient-applied parts should be wiped clean with a damp cloth, then cleaned with a hospital-grade germicide according to manufacturer directions. Avoid abrasive cleaners and highly concentrated germicide mixtures.
• Regular Checks (Monthly):
  • Power cord and plug: Inspect for fraying, kinks, or torn/cut insulation.
  • Sound head cable: Check for flexibility, kinks, fraying, and intact insulation.
  • Sound head face: Ensure no build-up of gel or foreign material.
  • Lead Wires: Check for fraying, kinks, or torn/cut insulation.

Technical Maintenance:

• Authorized Service: No attempt should be made to disassemble the unit. All maintenance and repairs must be performed by authorized personnel only. The manufacturer is not responsible for repairs by unauthorized persons.
• Annual 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.

Precautionary Instructions:

• Read and understand all precautionary and operating instructions.
• Do not operate when connected to non-Chattanooga Group devices or in a short-wave diathermy environment.
• The ultrasound generator should be routinely checked before each use to ensure controls function normally, especially intensity and treatment time.
• Avoid using sharp objects on the control panel buttons.
• Keep electrodes separated during treatment to prevent improper stimulation or skin burns.
• Replace fuses only with ones of the same type and rating.
• Ensure the unit is electrically grounded.
• Operate, transport, and store the unit within specified temperature and humidity ranges (59°F to 104°F, 30%-60% Relative Humidity).
• Handle the ultrasound applicator with care and inspect the treatment head and cables for cracks or damage before each use.
• Use caution with Interferential mode and always use new electrode pads to prevent electrical shock or burn.
• Do not raise intensity after treatment has started.
• Do not use on patients with implanted neurostimulation devices or in proximity to diathermy equipment.

This device is designed to be a reliable and effective tool for physical therapy, provided that all operational and maintenance guidelines are followed.

Chattanooga Group INTELECT LEGEND Series Specifications

General

Ultrasound Frequencies	1 MHz, 3 MHz
Display	LCD touchscreen
Voltage	100-240 VAC, 50/60 Hz
Pulse Width	50-400 microseconds
Modes	Continuous
Weight	2.3 kg (5.1 lbs)
Therapy Type	Combination Ultrasound & Electrical Stimulation
Patient Data Cards	Supports patient data storage