Intelect Legend Series Stim Model 2S & 4S User Manual Rev A

TABLE OF CONTENTS

Intelect® Legend Series Stim Miscellaneous... 29

FOREWORD... 1

Hand Held Probe (Optional)... 29

Product Description... 1

MAINTENANCE...30

SAFETY PRECAUTIONS...29

User Maintenance... 30

Precautionary Instructions... 2

Technical Maintenance... 30

Cautions... 3-4

WARRANTY...31

Warnings... 4-5 Dangers... 5 Indications/Contraindications and Adverse Effects... 6-9

OVERVIEW...1011 NOMENCLATURE...1213 SPECIFICATIONS...1420 Stimulator Output Parameters... 14-15 Electromagnetic Compatibility (EMC) Tables... 16-20

SETUP...21 Initial Setup Instructions... 21 Package Contents... 21

OPERATION...2229 Pain Management... 22 Interferential... 22-24 Premodulated... 25 Muscle Contraction... 26 High Volt... 26-27 Russian... 28

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FOREWORD

Intelect® Legend Series Stim

This manual has been written for the owners and operators of the Intelect® Legend Series Stim, models 2S and 4S. 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 Chattanooga Group's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of Chattanooga Group. 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.

Product Description With the same legendary performance, quality and value that has made the Intelect name respected world-wide, the Intelect® Legend Series Stim offers the convenience of a multi-waveform electrotherapy system with the advantage of easy-to-use 1-2-Go software. Features include Interferential, Premodulated, High Volt and Russian waveforms. Other features include our 1-2-Go Software, a clear, backlit LCD display and programmable power-up presets. This equipment is to be used only under the prescription and supervision of a licensed practitioner.

©2008 Encore Medical, L.P. and its affiliates, Austin, Texas, USA. Any use of editorial, pictorial or layout composition of this publication without expressed written consent from Chattanooga Group of Encore Medical, L.P. is strictly prohibited. This publication was written, illustrated and prepared for print by Chattanooga Group of Encore Medical, L.P.

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SAFETY PRECAUTIONS

Intelect® Legend Series Stim

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 Stim

• Read, understand, and practice the precautionary and operating

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

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 Stim unit when connected to any unit other than Chattanooga Group 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 Stim 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.

unit. 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 Stim and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty.

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SAFETY PRECAUTIONS

Intelect® Legend Series Stim

• 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.

• 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.

• Nylatex® Wraps contain dry natural rubber and may cause allergic reactions in patients with allergies to latex.

• 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. • 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.) • The user must keep the device out of the reach of children. • Long term effects of chronic electrical stimulation are unknown.

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SAFETY PRECAUTIONS

Intelect® Legend Series Stim

• Be sure to read all instructions for operation before treating a patient. • Dispose of all products in accordance with local and national

• 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.” • 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 Chattanooga Group dealer if the unit is not properly rated.

regulations and codes. • Use of controls, adjustments, or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Do not turn the unit on or off while it is connected to the patient. • Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this unit. Chattanooga Group 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.

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SAFETY PRECAUTIONS

Intelect® Legend Series Stim

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.

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SAFETY PRECAUTIONS

Intelect® Legend Series Stim

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 Stim

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 Stim

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.

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OVERVIEW

Intelect® Legend Series Stim

Operator Interface – (Pages 12-13) On the 2S: The operator interface consists of a Liquid Crystal Display (LCD) On the 4S: 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. The software control of the Legend Stim 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.

Operating Channels 1/2

Left Side Panel of 2S and 4S

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/Escape – (On Model 4S only) This button will return you to Main Menu or allow you to escape from a pop-up menu. Channel – (On Model 2S only) This button also allows you to change parameter display from Channel 1 to Channel 2.

Operating Channels 3/4

Right Side Panel of 4S

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. 10

OVERVIEW

Intelect® Legend Series Stim 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 2S of the Intelect® Legend Series Stim provides two channels or electrical stimulation, while Model 4S provides four channels. Stimulation Output Channels – The lead wires connect to these ports.

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NOMENCLATURE

Intelect® Legend Series Stim

Intelect Legend Series Stim 2S Parameter Display and User Panel

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NOMENCLATURE

Intelect® Legend Series Stim

Intelect Stim 4S Parameter Display and User Panel 13

SPECIFICATIONS

Intelect® Legend Series Stim

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 Stim

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 Stim

ELECTROMAGNETIC COMPATIBILITY EMC TABLES Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Intelect Legend Series Stim is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect Legend Series Stim should assure that it is used in such an environment.

Emissions Tests

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group I

The Intelect Legend Series Stim uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations IEC 61000-3-3

Complies

The Intelect Legend Series Stim is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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SPECIFICATIONS

Intelect® Legend Series Stim

ELECTROMAGNETIC COMPATIBILITY EMC TABLES CONTINUED Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Intelect Legend Series Stim is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect Legend Series Stim should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6kV contact ±8kV air

±6kV contact ±8kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

±2kV for power supply lines ±1kV for input/output lines

±2kV for power supply lines ±1kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1kV differential mode ±2kV common mode

±1kV differential mode ±2kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Intelect Legend Series Stim requires continued operation during power mains interruptions, it is recommended that the Intelect Legend Series Stim be powered from an uninterrupted power supply or a battery.

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-11

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

NOTE: UT is the a.c mains voltage prior to application of the test level.

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SPECIFICATIONS

Intelect® Legend Series Stim

ELECTROMAGNETIC COMPATIBILITY EMC TABLES CONTINUED Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Intelect Legend Series Stim is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect Legend Series Stim should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Intelect Legend Series Stim, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

d = [3,5]√P V1

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3V/m

d = [3,5]√P 80 MHz to 800 MHz E1 d = [7]√P 800 MHz to 2,5 GHz E1

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