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As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis As a Pulsed Current device, indications are for the following conditions: - Reduction of edema (under negative electrode) - Reduction of muscle spasm - Influencing local blood circulation (under negative electrode) - Retardation or prevention of disuse atrophy - Facilitation of voluntary motor function - Maintenance of increase of range of motion As an FES device, the indications for the following condition: - Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

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The Empi Active Transcutaneous Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma-acute pain

The Empi Active Transcutaneous Nerve Stimulator is a battery powered single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy. This device is intended to be easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity. It is a single-function electrotherapy device with one mode of treatment that allows for Transcutaneous Electrical Nerve Stimulation (TENS).

The Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors. The Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered. The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.

The Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

The SELECT® is a portable, dual channel TENS device with ten pre-programmed operational modes. It is powered by 3 standard AAA alkaline or rechargeable batteries. All operational modes produce the Empi Bi-Sourced® waveform. The user selects a pre-programmed mode by either pressing a Quick Select button with the picture of a body part needing treatment or by using the Program buttons to select one of ten program options. The user is able to adjust the intensity up or down. The lock mode prevents inadvertent changes to the intensity or the program option. The SELECT® is intended for use in the clinic or in the home with a prescription. A belt clip allows the patient to wear the Empi SELECT® on a belt or pants waistband. The SELECT® battery icon on the LCD will flash when the batteries need replacement. Compliance data can be retrieved by the clinician including number of sessions, average session length, and average intensity.

Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000. Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional. In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.

The Infinity Plus is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES) and interferential current stimulation (IFS). As a NMES device, the Infinity Plus device is indicated for the following conditions: - Retarding or preventing disuse atrophy . - Maintaining or increasing range of motion . - Re-educating muscles . - Relaxation of muscle spasm . - Increasing local blood circulation . - Prevention of venous thrombosis of the calf muscles immediately after surgery As an IFS device, the Infinity Plus is indicated for the following conditions: - Symptomatic relief of acute pain . - Symptomatic relief and management of chronic intractable pain . - As an adjunctive treatment for post surgical and post traumatic acute pain .

The Empi Infinity Plus Electrotherapy System is a battery-powered/line-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The Infinity Plus offers the following features: - Channel 1 to 4, which are multi-purpose outputs (IF and NMES) . - High Voltage output dedicated to the High Volt stimulation. (This is named CH5 in the Software Requirements Specification and Software Design Specification. It is a separate channel that is simply the output for the high voltage stimulation). - Channel 1, 2, 3 and 4 support stimulation with: - IF: 2 independent IF channels using the channel pairs: Channel 1/2 and Channel 3/4 - PM, NMES, Russian: 4 independent PM channels - Serial contractions: 4 dependent channels forming the movement pattern - HV out is dedicated to High Volt stimulation - All channel outputs are electrically separated from each other - Each channel has a dedicated intensity control, with the exception of the HV out. The intensity control of HV is achieved by using the Channel 1 intensity control. - Maximum stimulation of 100 mA for IF, PM, NMES, and Russian; 500 V for High Volt - Timed therapy sessions . - Continuous or cycled stimulation . - Adjustable pulse rates - Adjustable ON and OFF time controls . - Balanced symmetrical biphasic and monophasic high volt waveforms . - Forty-three programs: three conventional interferential, three premodulated interferential, seven High Volt, thirteen NMES, thirteen Russian and four Serial Contraction - Lock option for clinician to control treatment regimens and stimulus intensity - Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters with stimulus intensity of zero

The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions: - Symptomatic relief of acute pain . - . Symptomatic relief and management of chronic intractable pain - . Symptomatic treatment for post-surgical and post-trauma acute pain

The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features: - . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF) - . Each channel has a dedicated intensity control - . Maximum stimulation of 50 mA/500 V from each channel - . Timed therapy sessions - . Continuous stimulation - . Adjustable pulse rates - Balanced asymmetrical and symmetrical biphasic waveforms - . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation - . Lock option for clinician to control treatment regimens and stimulus intensity - . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero

The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.

The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES). As a NMES device, the 300 PV is indicated for the following conditions: - Retarding or preventing disuse atrophy . - . Maintaining or increasing range of motion - Re-educating muscles . - Relaxation of muscle spasm . - Increasing local blood circulation . - Prevention of venous thrombosis of the calf muscles immediately after . surgery As a TENS device, the 300 PV is indicated for the following conditions: - Symptomatic relief and management of chronic, intractable pain . - Adjunctive treatment for post-surgical and post-trauma acute pain . As an IFS device, the 300 PV is indicated for the following conditions: - Symptomatic relief of acute pain . - Symptomatic relief and management of chronic pain . As a FES device, the 300 PV is indicated for the following condition: - 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.

The Empi 300 PV Complete Electrotherapy System (300 PV) is a battery-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The 300 PV offers the following features: - . Two independent stimulation channels (CH1 and CH2), each of which can provide NMES, TENS, IF, or FES therapy. HV therapy can be accomplished using CH1. - Two independent intensity controls corresponding to each of the stimulation ● channels with a maximum stimulation of 100 mA from each channel. - Timed therapy sessions - Continuous or cycled stimulation - . Adjustable pulse rates - . Adjustable ON and OFF time controls - . Balanced asymmetrical and symmetrical biphasic waveforms - Thirteen preprogrammed regimens: five for NMES; one for TENS; one for ● IF; two for HV and four that can be customized by the clinician (two NMES and two HV). - Lock option for clinician to control treatment regimens and stimulus intensity . - Pause button for patient to pause stimulation. During pause, the timer will ● not countdown if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero. - . Optional external hand or foot switch used to control the device output during when used as an FES device for gait training