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The model 4400 series of TENS and Microcurrent devices are indicated for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

The Promax® family of non-invasive nerve stimulation therapy devices are userinteractive microprocessor controlled stimulators, designed for end-user comfort, ease of use, and to assist with therapy compliance. The Promax device has combined two modalities of electrical stimulation: (TENS and Microcurrent) used in a number of legally marketed predicate devices into one device. The Promax family of devices provide low frequency, non-invasive electrical stimulating therapy used for the symptomatic relief of chronic, intractable pain and the management of pain associated with post-traumatic or post-operative conditions. Although only one modality can be operated at a time the Promax with its six available preprogrammed TENS modes and three Microcurrent modes provide a plethora of options, so the patients unique therapeutic requirements can easily be selected. The following ten preprogrammed modes are available within the Promax family: Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated, Positive-DC Microcurrent, Biphasic Microcurrent, and Negative-DC Microcurrent. Each mode is made of a different pattern of electrical impulses and intensity settings. The SD mode delivers the unique pattern of electrical impulses with maximum intensity of 11microColumbs. The SMP mode delivers its pattern of electrical impulses at the highest intensity level (24 microColumbs) the Promax delivers. The intensity variety is another therapeutic option directed to meet the prescribed patients therapy requirements. Additional to the therapeutic option menu, the Promax devices provide a variety of features such as; last therapy recall, low battery notification, patient usage timers, open channel notification, as well as a self-diagnostic feature. The self-diagnostic feature is credited with notifying the user if the device requires maintenance prior to use. The many functions and features available with the Promax device-family are attributed to the size of the microprocessor. Many of these features available with the Promax are not available on other devices where the microprocessors size limitation or electrical mechanical controls are a factor. The microprocessor performance and unique operating software in the Promax provides for the pull-tables and algorithms that generate the waveforms, pulses, and duration/ time curves that are not available on other devices. One such feature is the last therapy recall protocol. This software driven feature allows the patient to resume therapy with little effort, following shut down or an open lead occurrence, (a result of poor continuity) with the same therapeutic settings. Another software driven feature is the Strength Duration Compensation protocol. This protocol starts out at zero amplitude or no stimulation to prevent patient-startling, and in a short time span based upon the Power Curve algorithm works the patient to the therapy settings without the patients experiencing uncomfortable sensations. This protocol is not available when the Promax is in the SMP mode. Different models of the Promax family provide different therapeutic modes to support more specifically the therapist with the modes and modalities needed to implement the prescribed clinical-protocol. Only the Promax XP-4400 model will have all 10 modes serving both the TENS and Microcurrent therapy menu. The Promax TN-4410 will have the TENS modes, while the Promax MC-4440 presents the Microcurrent modes. The Promax-Libra model LBR-4420 is the basic TENS model with a Constant and Burst mode.

TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain. The model 4900 series of Transcutaneous Electrical Nerve Stimulation (TENS) devices are user-interactive, microcontrolled-stimulators designed to provide lowfrequency, non-invasive electrical stimulating therapy to patients for the management of chronic, intractable pain. The model 4900 series design meets the latest electromedical standards and safety requirements, including the Performance Standard for Electrode Lead Wires and Patient Cables. The devices are microprocessor controlled and contain six preprogrammed therapy modes. The TENS devices (model 4900 series) firmware memory functions include: a nonvolatile read-only memory (ROM), last therapy recall, low battery notification and a self-check feature, which notifies the operator when a service condition exists. The ROM is designed to provide the therapy-mode accessibility, while providing the safety features, such as, zero amplitude at "startup" or when an "open channel condition is identified. The 4900 series of TENS devices are "user friendly" with a user interactive, softkey pad and a clearly visible, two-line, sixteen character, liquid crystal display (LCD) to show the operating parameters. The Model 4900S TENS device(s) are portable, personnel and designed to be easily handled with its light weight, trim (0.875" wide by 2.5" by 3.5") rectangular shaped, durable plastic shell. The device is fitted with a belt clip and can easily be worn without inhibiting the mobility of the patient. The device operates efficiently with a 9-volt battery power supply. The device delivers an output of 25 mAmp for 55 hours under a 500K Ohm load. The efficient power allocation (between the operation of the device and the electrical stimulation delivered to the patient) results from the interaction of a microcontroller; microprocessor; a crystal-controlled oscillator; RAM memory; circuit interface drivers; and a custom ROM. The crystal-controlled oscillator insures accurate timing of all pulse waveforms. The microprocessor-controller, in addition to operating the "house keeping functions", such as the LCD readouts, power on, open channel-control and the power off functions, maintains communications to the custom ROM and the variety of modalities available for the different models. The six available nreprogrammed modalities: Constant mode: SMP mode: Burst Mode: Rate Modulated Mode, Width Modulated Mode, and Multi-Modulated Mode. The physician or physical therapist may choose to use, depending on the specific model of TENS device, any one of six available modalities.

The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.