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- Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period. - High-resolution recording of surface ECG data. - Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.

The SpiderView ™ Holter recorder is designed to acquire and store, in a digital format, multiple channels of surface ECG data (from 2 to 9 Leads) for a period up to 96 hours. The device stores the acquired ECG data on a removable flash memory card. ECG signals are converted at a rate of 200 to 1000 samples per second, which allows accurate reproduction of the ECG signal to perform signal averaging ECG analysis. The Holter scanner software (sold separately) reads these data and prints them out in tabular or graphical form. This recorder does not perform any analysis on the ECG data. SpiderView™ is supplied in a case containing a 16, 32, or 64 MB flash-memory card, one 1.5 V AA battery, a carrying case, a strap, five patient cables, a set of ECG electrodes, and a user's manual.

ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle. ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.

Stela™ Model BT45/46 and UT46 straight tined pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the ventricle. Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. Stela™ Model UT 46 and UJ45 are silicone rubber, unipolar transvenous leads, similar in design and construction to bipolar models BT45/46 and BJ44/45, respectively. The following silicone rubber material change was performed on Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads: Affected components: Straight extruded tubing components (inner and outer lead isolation) Current material: Dow Corning HP 77020 SP50 New material: Applied Silicone* HCRA HP 50E (part number 40094)

- Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period. - High-resolution recording of surface ECG data. - Analysis of recorded Holter ECG data.

Syneflash™ is a light-weight digital ambulatory electrocardiogram (ECG) recorder (Holter monitor) equipped with a graphic LCD screen, and using a flash-memory card for data storage. It allows 24-hour ambulatory ECG recording and high-resolution recording, using 2 or 3 channels. Syneflash™ is supplied in a case containing a 10-, 20- or 40-MB flash-memory card, two 1.5-V AA batteries, a carrying case, a strap, a five-lead (or seven-lead) patient cable and a user's manual. Syneview™ is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained with Syneflash™. Syneview™ is a Microsoft Windows95/98-based application run on an IBM-compatible personal computer equipped with a flash-card reader.

ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. J-shaped leads are intended for permanent pacing and sensing of the atrium.

The Stela™ Model UJ45 is a silicone rubber, tined, J-shaped, unipolar transvenous lead that provides a permanent electrical pathway between a pacemaker and the atrium. It is similar in design and construction to other such leads in commercial distribution.

- AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle), - Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers. The electronic circuit and battery are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions are assured by a hybrid circuit with passive components and integrated circuits (microprocessor and custom circuit). The programmer system consists of a programming head, programmer software, and an IBM-compatible PC.

ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.

Stela™ BJ44 and BJ45 models are silicone rubber, tined, J-shaped, bipolar transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. They are similar in design and construction to other such leads in commercial distribution.