Intelect Legend Series Combo Model 2C & 4C User Manual Rev B

TABLE OF CONTENTS

Intelect® Legend Series Combo

Foreword... 1

Ultrasound... 25

Product Description... 1

Combination Therapy... 26

SAFETY PRECAUTIONS... 2-10

Miscellaneous... 27 Hand Held Probe (Optional)... 27

Precautionary Instructions... 2

Maintenance... 28

Cautions... 3-4

User Maintenance... 28

Warnings... 4-5

Technical Maintenance... 28

Dangers... 5

Warranty... 29

Indications/Contraindications and Adverse Effects... 6-10

overview... 11-12 Nomenclature... 13 specifications... 14-16 Stimulator Output Parameters... 14-15 Ultrasound Output Parameters... 16

setup... 17 Initial Setup Instructions... 17 Package Contents... 17

Operation... 18-27 Pain Management... 18 Interferential... 18-20 Premodulated... 21 Muscle Contraction... 22 High Volt... 22-23 Russian... 24

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FOREWORD

Intelect® Legend Series Combo

This manual has been written for the owners and operators of the Intelect® Legend Series Combo, models 2C and 4C. It contains general instructions on operation, precautionary practices, maintenance and parts information. In order to maximize use, efficiency and the life of your unit, please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the unit. Specifications put forth in this manual were in effect at the time of publication. However, owing to DJO, LLC's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC. Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the application of electrotherapy and ultrasound.

Product Description With the same legendary performance, quality and value that has made the Intelect name respected world-wide, the Intelect® Legend Series Combo offers the convenience of a full-featured stimulator and ultrasound in one device. Easy-to-use 1-2-Go software makes this unit a pleasure to operate. Features include Interferential, Premodulated, High Volt and Russian waveforms. Dual frequency ultrasound features a 5 cm2 soundhead, which delivers 1 or 3.3 MHz frequencies, 10%, 20%, 50% and continuous duty cycle selections, and head warming. Unique Electronic Signature™ control allows all available ultrasound applicators to be interchangeable. Ultrasound operation is independent or in combination with Interferential, Premodulated and High Volt waveforms. This equipment is to be used only under the prescription and supervision of a licensed practitioner.

©2009 DJO, LLC Vista, California, USA. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

Precautionary INSTRUCTIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as follows:

DANGER Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury. Dangerous Voltage

CAUTION Text with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient in certain treatment configurations of waveforms.

NOTE: Throughout this manual “NOTE” may be found. These notes are helpful information to aid in the particular area or function being described.

WARNING Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

• DO NOT permit any foreign materials or liquids to enter the unit.

• Read, understand, and practice the precautionary and operating

Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire, or personal injury. • This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, connect the equipment to an outlet on a different circuit from that to which the other device(s) are connected and consult the factory field service technician for help. • Where the integrity of the external protective earth conductor arrangement is in doubt, equipment shall be operated from its internal electrical power source. • DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. • Failure to use and maintain the Intelect Legend Series Combo and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty. • Before each use, inspect the applicator for cracks, which may allow the ingress of conductive fluid.

instructions found in this manual. Know the limitations and hazards associated with your treatment table. Observe any and all precautionary and operational decals placed on the unit. • DO NOT operate the Intelect Legend Series Combo unit when connected to any unit other than Chattanooga devices. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel. • This unit should be operated, transported, and stored in temperatures between 59° F and 104° F (15° C and 40° C), with relative humidity ranging from 30%-60%, and where the atmospheric pressure is between 950 h Pa and 1050 h Pa. • Inspect cables and connectors before each use. • The Intelect Legend Series Combo is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient. • A licensed practitioner experienced with physical therapy must be familiar with all instructions contained in this manual before administering therapy. • Handle the applicator with care. Inappropriate handling of the applicator may adversely affect its characteristics.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

• Powered muscle stimulators should be used only with the leads and

• DO NOT remove the cover. This may cause unit damage,

electrodes recommended for use by the manufacturer.

malfunction, electrical shock, fire, or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately and consult the dealer for repair service. • Nylatex® Wraps contain dry natural rubber and may cause allergic reactions in patients with allergies to latex.

• Before administering any treatment to a patient you should become

acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of electrotherapy. • To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance procedures. • Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns. • Stimulation should not be applied over the anterior neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. • Stimulation should not be applied transthoracically because the introduction of electrical current into the heart may cause cardiac arrhythmia. • Stimulation should not be applied over swollen, infected, and inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. • Stimulation should not be applied over, or in proximity to, cancerous lesions. • Output current density is inversely related to electrode size. Improper application may result in patient injury.

• These devices are restricted to sale by, or on the order of, a physician

or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner. • Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes. • The user must keep the device out of the reach of children. • Long term effects of chronic electrical stimulation are unknown. • Always keep the sound head in constant motion. • Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it. (i.e. cell phones, etc.) • Do not turn the unit on or off while it is connected to the patient.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

• Always keep the sound head in full contact with the patient’s skin or

• Patients with an implanted neurostimulation device

submerged under water when setting intensity. • Use ample conductive gel to ensure good coupling throughout the treatment. If needed, apply when setting intensity. • Use of controls, adjustments, or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Do not apply the Ultrasound Applicator to the patient during the Head Warming period. Applicator must remain in Applicator Hook duing the Head Warming period. • Do not drop the applicator on hard surfaces. Do not cool an overheated sound head with ice water or ice packs. Do not allow the sound head to reach maximum temperatures repeatedly. All of these conditions are likely to damage the sound head crystal. Damage resulting from these conditions is not covered under the warranty. • Be sure to read all instructions for operation before treating a patient. • Dispose of all products in accordance with local and national regulations and codes. • Use of controls, adjustments, or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this unit. DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables may result in increased emissions or decreased immunity of this unit.

must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy, or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound, and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage, and can result in severe injury or death. Injury, damage, or death can occur during diathermy therapy even if the implanted neurostimulation system is turned “off.” • DO NOT connect the unit to an electrical supply without first verifying that the power supply is the correct voltage. Incorrect voltage may cause unit damage, malfunction, electrical shock, fire, or personal injury. Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number Plate. Contact your DJO, LLC dealer if the unit is not properly rated.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

Indications/Contraindications AND Adverse Effects for Electrical Stimulation Interferential and Premodulated Indications • Symptomatic relief of chronic, intractable pain • Management of pain associated with post-traumatic or postoperative conditions Contraindications • This device should not be used for symptomatic pain relief unless etiology is established or unless a pain syndrome has been diagnosed. This device should not be used on patients with demand type cardiac pacemakers. This device should not be used over cancerous lesions. • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through the head). Warnings • The long-term effects of chronic electrical stimulation are unknown. Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems, or epilepsy. • Benefits of Interferential stimulation have not been established for pain of central origin. • This device is to be used as a symptomatic treatment for pain and has no curative value. Patients should be cautioned and their activities regulated if pain is suppressed that would otherwise serve as a protective mechanism. • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is being utilized. 6

SAFETY PRECAUTIONS

Intelect® Legend Series Combo

Indications/Contraindications AND Adverse Effects for Electrical Stimulation Precautions • Isolated cases of skin rash may occur at the site of electrode placement following long-term applications. The irritation may be reduced by use of an alternate conductive medium or an alternative electrode placement. • Effectiveness of this treatment is dependent upon patient selection. Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic electrical stimulation. Russian and High Volt Indications • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Contraindications • This device should not be used on patients with demand type cardiac pacemakers. • This device should not be used on cancer patients.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

Indications/Contraindications AND Adverse Effects for Electrical Stimulation Warnings • The long-term effects of chronic electrical stimulation are unknown. • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems. • Adequate precautions should be taken in the cases of persons with suspected or diagnosed epilepsy. • Do not stimulate over the carotid sinus nerve, especially in persons with a known sensitivity to the carotid sinus reflex. • Severe spasm of the laryngeal and pharyngeal muscles may occur if the electrodes are placed over the neck or mouth. The contractions may be strong enough to cause breathing difficulty or even close the airway. • Do not perform therapeutic electrical stimulation transcerebrally (through the head). • Therapeutic electrical stimulation should not be applied over swollen, infected or inflamed areas of skin eruptions, (e.g., phlebitis, thrombophlebitis and varicose veins). • Use extreme caution in transthoracic application of therapeutic electrical stimulation, introduction of electrical current into the heart may cause arrhythmia. • This device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. • This device should be kept out of the reach of children. Precautions should be observed in the presence of the following: • Following recent surgical procedures especially when muscle contractions could disrupt the healing process. • Where sensory nerve damage is present by a loss of normal skin sensation. • When there is a tendency to hemorrhage following acute trauma or fracture. 8

SAFETY PRECAUTIONS

Intelect® Legend Series Combo

Indications/Contraindications AND Adverse Effects for Electrical Stimulation • Over the menstruating uterus. • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or the electrical conductive medium. The irritations can usually be reduced by the use of an alternate conductive medium or alternative electrode placement. Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic electrical stimulation. Ultrasound Indications and Contraindications Indications Ultrasound for use in applying deep heat can be used for 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 Intelect® Legend Series Combo can provide therapeutic deep heating between 40 and 45° C in all of its operating modes, while using any of the applicators available for this device. Contraindications • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used when cancerous lesions are present in the treatment area. • This device should not be used when open wounds are present in the treatment area.

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SAFETY PRECAUTIONS

Intelect® Legend Series Combo

• Other contraindications are patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. • This device should not be used over or near bone growth centers until bone growth is complete. • This device should not be used over the thoracic area if the patient is using a cardiac pacemaker. • This device should not be used over a healing fracture. • This device should not be used over or applied to the eye. • This device should not be used over a pregnant uterus. • This device should not be used on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result. • Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned "off."

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OVERVIEW

Intelect® Legend Series Combo

Operator Interface – The operator interface consists of a Liquid Crystal Display (LCD) and three Light Emitting Diodes (LEDs). The operator is able to view Channel designation, Treatment time and Output on the LEDs and Parameter options on the LCD.

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OVERVIEW

Intelect® Legend Series Combo

The software control of the Intelect Legend Series Combo has been designed to be extremely user friendly. First press the treatment mode button of your choice, increase intensity and press start. The software also allows great flexibility should you desire to change parameters. Changing Parameters – To change parameters, use the up/down arrows to select the parameter, then press enter. If there are two options, pressing enter will toggle between those choices. If there are three or more options, pressing enter will display a pop-up window with the choices listed. Use the up/down arrows to choose an option and then press enter to accept. Enter – The up/down arrows control the Select Highlight box and the enter button confirms the change. Main Menu – This button will return you to Main Menu or allow you to escape from a pop-up menu. 12

NOMENCLATURE

Intelect® Legend Series Combo Time – The up/down arrows increase or decrease the default treatment time. Power/Intensity – The up/down arrows increase or decrease the intensity/power. Treatment Selection– There are four waveform selections, plus Ultrasound and Combo.

Operating Channels 1/2 Left Side Panel of 2Cand 4C

Start – This button will start the treatment on the selected channel. Stop – This button will stop the treatment on the selected channel. Pause – This button will pause the treatment on the selected channel. Operating Channels – Model 2C of the Intelect® Legend Series Combo provides two channels of electrical stimulation and one channel of ultrasound. Model 4C provides four channels of electrical stimulation and one channel of ultrasound. Stimulation Output Channels – The lead wires connect to these ports. Ultrasound Port – The Intelect Legend Series Combo includes a 5 cm2 ultrasound applicator, which connects to the port marked Ultrasound. The advanced electronics of the Intelect Legend Series Combo transmits stored data from the applicator to the unit each time the device is powered on and ultrasound is accessed. This sophisticated Electronic Signature™ assures accurate calibration with any of the interchangeable applicators.

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SPECIFICATIONS

Intelect® Legend Series Combo

Stimulator Output Parameters Parameter Function Carrier Frequency Beat Frequency Scan Mode Scan Time Sweep Time Duty Cycle Ramp Up / Ramp Down Cycle Time Alternating Time in Seconds Polarity Amplitude Voltage (max) Treatment Time

Interferential Electrodes 5000 Hz 0-200 Hz On/Off 15 sec 15 sec N/A N/A 15 sec N/A N/A 0-50 mA RMS 200 Volts 1 to 60 min

Premodulated Electrodes 5000 Hz 0-200 Hz N/A N/A 15 sec N/A N/A N/A N/A N/A 0-50 mA RMS 200 Volts 1 to 60 min

N/A = Not Applicable

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SPECIFICATIONS

Intelect® Legend Series Combo

Stimulator Output Parameters Parameter Function Mode Carrier Frequency Pulse Frequency Burst Frequency Phase Duration Interphase Interval Duty Cycle Ramp Up / Ramp Down . Cycle Time Polarity Amplitude Voltage (max) Output Current Treatment Time

Russian Electrodes Single, Recipr. Co-Contraction 2500 Hz N/A 20-100 BPS N/A N/A 10-50% 5, 1, 2, 5 sec 5/5,10/10, 10/20 4/12, 10/30, 0/50 Continuous N/A 0-100 mA RMS into 500 ohm load 200 Volts N/A 0-60 min

High Volt Electrodes, Probes Single N/A 10-120 pps N/A N/A N/A N/A N/A 5/5,10/10, 10/20 4/12, 10/30, 0/50 Continuous Pos. (+), Neg. (-) 0-500 mA RMS 0-500 Volts 0-2500 mA Peak 0-60 min

N/A = Not Applicable 15

SPECIFICATIONS

Intelect® Legend Series Combo

Ultrasound Output Parameters Channel Frequency Duty Cycle Pulse Duration Ultrasonic Power Output Meter Accuracy Temporal Peak/Average Intensity Ratio Output Timer Accuracy Soundhead Maximum Beam Non-uniformity Ratio Beam Type

US (Ultrasound) 1 MHz ± 5% & 3.3 MHz ± 5% 100% (continuous mode) 50%, 20%, 10% (pulsed mode) 5 msec ± 20% (50% duty cycle, pulsed mode) 2 msec ± 20% (20% duty cycle, pulsed mode) Variable from 1-20 watts, 10 cm2 crystal Variable from 0.4-10 watts, 5 cm2 crystal Variable from 0.2-4 watts, 2 cm2 crystal ± 20% for any output above 10% of maximum 2:1 ± 20% for 50% duty cycle 5:1 ± 20% for 20% duty cycle 9:1 ± 20% for 10% duty cycle Continuous: 1 MHz or 3.3 MHz nominal signal that is activated as long as the timer is operating. Pulsed: 1 MHz or 3 MHz signal, modulated 100% by the 100 Hz rectangular wave with the selected duty cycle. ±0.2 minute Effective Radiating Area: 8.5 cm2 ± 1.5 cm2 for the 10 cm2 crystal 4.0 cm2 ± 1.0 cm2 for the 5 cm2 crystal 1.8 cm2 -0.4/+0.2 cm2 for the 2 cm2 crystal 5.0:1 Collimating 16

SETUP

Intelect® Legend Series Combo

Initial Setup Instructions

Optional Accessories

Remove the Intelect Legend Series Combo unit and any additional items ordered from the carton and inspect for damage that may have occurred during shipment. Check the voltage rating on the serial decal located on the bottom of the unit. Plug the system power supply in to a 100 Volt to 220-240 Volt AC outlet, as required.

The following is a list of optional accessories available for the Intelect Legend Series Combo: 78046 78048 79977 72853 72852 10648 10832 10648 10828 78022

CAUTION • DO NOT attempt to use Direct Current (DC). • DO NOT place unit in a location where the power cord could be tripped over or pulled out during treatment. • DO NOT attempt to use the unit if it is not properly grounded.

Package Contents Standard Accessories The following accessories are included with your Intelect Legend Series Combo: 78047 4248 12213 12214 28389

Applicator, Ultrasound 5cm2 Conductor™ Gel Lead, 120", Red/Black Channels 1 and 2 Lead, 120”, Channels 3 and 4 (Model 4C only) CD User Manual 17

Applicator, Ultrasound 10 cm2 Applicator, Ultrasound 2 cm2 High Volt Probe Kit Electrodes, Carbonflex, 3" Round, Red Electrodes, Carbonflex, 3" Round, Black Nylatex, 2-1/2" x 24", Sewn Strap, Nylatex, Long 2-1/2"x 48" Strap, Nylatex, Medium, 2-1/2"x 24" Strap, Nylatex, Short, 2-1/2"x 18" Patient Control Center

OPERATION

Intelect® Legend Series Combo

Pain Management The management of post-traumatic, post-operative or chronic intractable pain associated with many areas of the body can be a difficult task. The ntelect Legend Series Combo provides multiple waveforms and many parameter settings to manage pain. Two waveforms are available for Pain Management therapy: Interferential and Premodulated.

Interferential The Interferential waveform consists of two channels, each with a sinusoidal waveform; one of fixed frequency and one of variable frequency. When the four electrodes are positioned so that the two channels cross each other, the two waveforms mix within the tissue to produce a train of pulses whose frequencies and amplitude are dependent on the sweep mode, beat frequency and amplitude settings, respectively. Press the Interferential button to select this waveform. Ch. Select controls the method for setting amplitude. The Both Channels mode changes intensity equally. The Channel 1 option changes ONLY channel one and the Channel 2 option ONLY changes channel two. This is helpful when you need to balance the output between channels. When you highlight Amplitude Modulation and press the enter button, 3 options are displayed. They are 40% Scan (default), 100% Scan and Static (no scan). Scan Percentage is the percentage of decrease from the maximum amplitude. Scan is amplitude modulation, expressed as a percentage of the amplitude. The rhythmical varying of the amplitude of each channel produces the perceived movement of the Interferential field.

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