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The Compex® Rehab is an adjunctive multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES). The Compex® Rehab is indicated for the following conditions: - Re-educating muscles - Relaxation of muscle spasm - Increasing local blood circulation - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion

The Compex® Rehab system consists of the following components: - 1x Stimulator - 1x Wire Set - 2x Small Performance Snap Electrode package - 2x Large Performance Snap Electrode package - 1x Fast Charger - 1x Belt clip - 1x User Manual These components are packaged together in a carrying case. The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of four (4) different menus that allow the following functions: - Options Menu: set up the device, e.g. operating languages, LCD contrast, LCD backlight, Audio output level; - Body Area Menu: select a desired muscle group, e.g. Shoulder, Hip or Knee; - Treatments Menu: select a preset program, e.g. Massage, Endurance, Strength; - Stimulation Menu: select lead wire channels and adjust the stimulation intensities. The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable program. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. Power for the device is provided from a 4.8 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover. Each of the four (4) lead wires will connect the output of the stimulator to each of the electrodes for each respective output channel. Each lead wire will be connected to the stimulator using a high friction, and forced fitting, mechanically shielded connection is a mechanically shielded snap connector (compliant with the 21 CFR §898.12 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES). Each electrode set requires a lead/connector assembly. The electrode connector is compatible with the cable connector. Up to four Active/Passive sets of electrodes are required. The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10. For patient safety, the device is designed to prohibit use of the device on patients while the battery is being charged. A red plastic cover inside the charging socket blocks the charger pin when the lead wires are still connected to the device. Unplugging the lead wire cables unlocks the red plastic cover and allows the charger pin plug in the charging socket. Connecting a charger to the stimulator automatically starts the charging procedure. A battery symbol on the LCD indicates the status of the battery charging. The battery pack of the stimulator is charged by a switching adapter which supplies an output current of 1.4 A +/-100 mA and an output voltage of 9V DC +/- 2%. The primary plug is an American 2 pin AC type able to handle input voltage from 90 to 240V AC and at a maximum input current of 0.5 A. The secondary plug on the stimulator is a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger has a short circuit protection. Maximum dimensions of the charger are 72 x 52 x 35 mm. The Compex Rehab provides three muscle stimulation training programs which correspond to target muscle groups (Shoulder, Knee, Hip) of the patient intended for use during rehabilitation. These rehabilitation programs are: - Massage - Endurance - Strength

Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffiess, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases. Generally accepted indications for use: - Pain Relief . - Reduce Muscle Spasm . - . Decrease Joint Stiffness - . Contractures - Increase Blood Flow - Chronic Inflammatory Conditions . - . Bursitis - Tenosynovitis - Synovitis . - Chronic Inflammatory Pelvic Disease

The Intelect® SWD 100/ Senior Shortwave Diathermy devices consists of a power supply that provides power to a radio frequency oscillator. This radio frequency oscillator provides stable, drift-free oscillations at the required frequency. The power amplifier generates the power required to drive the different types of electrodes. The output resonant tank tunes in the patient as part of the circuit and allows maximum power to be transferred to the patient. The output intensity controls the percentage of maximum power transferred to the patient circuit. The tuning control adjusts the output circuit for maximum energy transfer from the radio frequency oscillator. The power output meter monitors only the current that is drawn from the power supply and not the energy being delivered to the patient. The power output produces sufficient energy to raise the tissue temperature into a therapeutic range. The specific absorption rate (SAR) represents the rate of energy absorbed per unit area of tissue mass. Patient sensation provides the basis for recommendations of continuous shortwave diathermy dosage and thus varies considerably with different patients. The following are recommended dosage guidelines: Dose I (lowest): No sensation of heat Dose II (low): Mild heating sensation Dose III (medium): Moderate (pleasant) heating sensation Dose IV (heavy): Vigorous heating that is tolerable below the pain threshold Therapy may be delivered to the patient via either capacitance or induction techniques. The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices use the following accessories: - Capacitive Electrodes - Pair of 80mm round - Pair of 120mm round - Pair of 165mm round - 180mm x 120mm flexible rubber electrodes - 250mm x 145mm flexible rubber electrodes - Inductive Electrodes - Monode 14cm - Diplode 18cm x 39cm Each of these techniques can affect different biological tissues, therefore selection of the appropriate electrodes is essential for effective treatment.

The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Compex® Sport Plus may therefore be considered a technique of muscle training.

The Compex® Sport Plus system consists of these components: - 1x Stimulator - 1x Wire Set - 2x Small Performance Snap Electrode package . - 2x Large Performance Snap Electrode package - . 1x Fast Charger These components are packaged together in a carrying case along with the user manual, belt clip and a battery charger. The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu). The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable exercise routine. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which is located below the LCD. The function is defined by a symbol on the LCD corresponding to the button below. Power for the device is provided from a 4.6 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover. Each lead wire will connect the output of the stimulator to the electrodes for each output channel. Each lead wire will be connected to the stimulator using a high friction, forced fitting, mechanically shielded connector. Electrode connection shall be a mechanically shielded snap connector (Compliant with protected lead wire and patient cable safety requirements). Electrode configurations are made up of existing electrodes are configured for the intended use applications and may be unique to one or more application. Up to four Active/Passive sets of electrodes are required. Each electrode set requires a lead/connector assembly. The electrode connector shall be compatible with the cable connector. The electrode assembly shall be compliant with regulatory requirements. The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10. It is not possible to connect the stimulator to the charger at the same time as the lead wires. Connecting a charger to the stimulator results in an automatic start of the charging procedure which is indicated by a symbol on the LCD showing the status of the battery pack. The battery pack of the stimulator shall be charged by a switching adapter able to supply an output current of 1.4 A +/-100 mA and an output voltage of 9 VDC +/- 2%. The primary plug shall be of American 2 pin AC type able to handle input voltage from 90 to 240 VAC and at a maximum input current of 0.5 A. The secondary plug, to be attached to the stimulator, shall be a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger shall have short circuit protection. Maximum dimensions of the charger shall be 72 x 52 x 35 mm.

Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Vitalstim Experia therapy is a comprehensive electrotherapy device for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended use is achieved by the benefit of powered muscle stimulation and muscle activity biofeedback in one comprehensive device. The intended patient outcome is to regain control of muscles to swallow food without aspirating. VitalStim™ waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional. VMS™ waveform is a square symnetrical biphasic waveform with the application for use on the musculature of the face, The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS™ waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function. HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in posttraumatic conditions or after neurological insult with impaired neuromuscular function. sEMG™ is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions. The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with: ➤ Protruding discs ➤ Bulging discs ➤ Herniated discs ➤ Degenerative disc disease ➤ Posterior facet syndrome ➤ Acute facet problems ➤ Radicular pain ➤ Prolapsed discs ➤ Spinal root impingement ➤ Hypomobility ➤ Degenerative joint disease ➤ Facet syndrome ➤ Compressions fractures ➤ Joint pain ➤ Discogenic pain EMG (a.k.a. sEMG) Determination of the activation magnitude and timing of muscles for: a) retraining of muscle activation b) coordination of muscle activation Determination of the force produced by muscle for control and maintenance of muscle contractions Relaxation muscle training Muscle re-education

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner. The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch. The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.

The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee, ankle, wrist, shoulder). Distraction can be applied in a variety of programmable patterns, cycles and functions. The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with: - > Protruding discs - > Bulging discs - > Herniated discs - > Degenerative disc disease - > Posterior facet syndrome - > Acute facet problems - > Radicular pain - > Prolapsed discs - >> Spinal root impingement - > Hypomobility - > Degenerative joint disease - > Facet syndrome - > Compressions fractures - > Joint pain - > Discogenic pain The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

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For Infrared Lamp (Laser) Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for: - temporary increase in local blood circulation - temporary relief of minor muscle and joint aches, pains and stiffness - relaxation of muscles - temporary relief of muscle spasms - temporary relief of minor pain and stiffness associated with arthritis

Vectra Genisys Laser System (Intelect XT Laser System)

For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS) 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 Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain For FES Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait For DC Continuous Mode Relaxation of muscle spasm For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis b) Bursitis with slight calcification c) Myositis d) Soft tissue injuries e) Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness b) Capsular scarring

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For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS): 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. Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS): Symptomatic relief or management of chronic, intractable pain, Post-traumatic acute pain, Post-surgical acute pain. For FES: Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait. For DC Continuous Mode: Relaxation of muscle spasm. For EMG: To determination the activation timing of muscles for: a) retraining of muscle activation, b) coordination of muscle activation, An indication of the force produced by muscle for control and maintenance of muscle contractions, Relaxation muscle training, Muscle re-education. For EMG triggered Stim: Stroke rehab by muscle re-education, Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. For Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures, 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis, b) Bursitis with slight calcification, c) Myositis, d) Soft tissue injuries, e) Shortened tendons due to past injuries and scar tissues, 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness, b) Capsular scarring.

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For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis b) Bursitis with slight calcification c) Myositis d) Soft tissue injuries e) Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness b) Capsular scarring

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