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cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboard. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and the device can acquire and transmit an ECG trace in analogue (via sound coupling) or digital formal (USB port or via the wireless Bluetooth channel) to a remote PC. The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient. The equipment is intended to be used by trained medical personnel or physicians. cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel. The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device. Indication for use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

cardiette microtel is an electrocardiograph providing the following characteristics: - · standard and/or rechargeable internal AA batteries - · simultaneous acquisition and storage of the 12 standard leads acquired from a 10 wire cable, or 7 leads (6 peripheral + 1 precordial) acquired from a 5 wire cable. - · storege of 10 second ECG of acquired ECG signals (in 12 and 7 lead formats) - · storage of up to 40 ecg recordings (optional) - · digital filters for AC interference suppression and base-line drift - · transmition of the ECG in an analogue format via sound coupling or in digital format (SCP format) via the USB port and also via the wireless Bluetooth channel - · graphic LCD display for user interface and ECG visualisation (the ecg trace may be used only to evaluate the quality of the acquired ecq) - · functional keyboard for patient identification input data (disabled in the basic product), ECG recording and ECG sending operations

CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display. The equipments are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and is recorded on thermal paper. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient. The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology. Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements. The equipments are intended to be used by trained medical personnel or physician's.

CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics: - Mains and internal battery operation - Manual acquisition of the 12 Standard Leads - Simultaneous acquisition of the 12 Standard Leads - Storage of 10 seconds of acquired ecg signal - Storage of up to 40 ecg recordings (optional) - Multichannel Ecg printout on thermal paper - Copy function of the stored ecg - High resolution digital thermal printer - Digital filters for AC interference suppression and base-line drift - Time and date printout - Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface - Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional): - Representatives Templates of each lead including markers on fiducial A points - Summary of mean measurements A - Summary of measurements performed on each lead A - A Rythm Analysys Statements - Rythm graphical representation A - Signal noise detection and information A - A Specific findings on QRS complex - A Conduction statements - QRS T Diagnostic Statements A - Summary of measurements performed on each lead - Arrhythmia monitoring detection - A Heart Rate Variability - graphic LCD display for user interface and ECG visualisation - Patient input data for Interpretation, identification and filing purposes More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities.