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The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional. The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity. The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.

The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.

The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments. The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods. The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

The BioModule 3-M1, a physiological sensor / transmitter is composed of: - proprietary hardware and firmware, enclosed in - a user case (puck) with a re-chargeable battery. . - . a adhesive electrode set and - A cradle (to recharge battery and transfer internally stored date to an ancillary computer). The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.

The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECG use (CenterRidge Diagnostic ECG Electrode) and one for monitoring ECG use (CenterRidge Monitoring ECG Electrode). The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is less than 24 hours. The CenterRidge Monitoring ECG Electrode is a monitoring, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.

The CenterRidge ECG Electrodes are non-traditional tab electrodes, capable of diagnostic or monitoring use, depending on materials used in construction, and are intended to acquire ECG signals from the surface of the body. Both the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode are of multilayer construction, using medical grade foam or cloth backing material, a silver/silver chloride coated sensing element and solid hydrogel. The raw materials used in the CenterRidge Electrodes are equivalent to the materials used in the predicate legally marketed ECG electrodes specified above. The intended patient population is adult and pediatric. The skin surface contact area and proportional electrode size will be adjusted to fit the specific procedure and patient population. The primary difference between the CenterRidge Electrodes and the predicate devices are geometry and shape. The 3M Health Care model 2330 and the Bio-Detek model DE1070 are traditional tab electrodes with a tab sensing element located on the perimeter of the electrode, whereas the Team Innovation CenterRidge electrode has the sensing element located within the body of the electrode. The internal location of the CenterRidge sensing element emulates the snap on the Bio-Detek models LT301SG(PSG), LT401SG(PSG) and LT401SG(PSG).

ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates. By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.

Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application. Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape. Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent). Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.

The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The electrodes are for single patient use only.

Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician. Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices. Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor, a hydrogel, and a medical adhesive. The NEO/NEO X electrodes can be used for all pediatric populations (including neonates) The adhesive on the NEO/NEO X electrodes is suitable in the high humidity environment in the incubators and still gentle to the fragile neonatal skin.

INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.

INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon conductive layer, and a conductive gel. These are configured as ten electrodes applied to a siliconized card, with 10 cards per pouch

The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram.

These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.

The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.

The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.

Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.