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The Kenz Cardico 1211 is indicated for routine ECG acquisition and ECG signal analysis. It is equipped with an auto-analysis function and is not intended to replace the physician's reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (age > 19 years). Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block. Locations: Hospitals. Caution: US Federal law restricts this device to sale by or on the order of a physician.

Kenz Cardico 1211 is an electrocardiograph with the following functions and capabilities. · Simultaneous acquisition of the 12-Lead electrocardiogram (ECG). · The sampling frequency of P-QRS-T deflections is 1 kHz. - · The sampling frequency of the pacemaker pulse detection is 10 kHz. - · 5.7 inch LCD display providing the following information. - a) ECG waveform - b) Patient's demographic data - c) ECG diagnostic interpretation - d) Summary of Internal Memory data - · Thermal printer that will print ECG waveforms and analysis reports. - · Digital filters to minimize AC interference, baseline drift and electromyogram interference. - · Built-in memory and external memory (Compact Flash card) for 1,000 12-Lead ECG data. - · As a measure against cybersecurity, in order to secure the integrity of the data in the external memory, only the CF card specially formatted by Suzuken Co., Ltd. can be used with Kenz Cardico 1211. - · Built-in power supply unit (AC 110-240 V). - · Built-in battery, after charged for 8 hours, supports one hour operation during emergency. - · ECG interpretation software providing the following information. - a) Summary of measured values of ECG waveform in each Lead - b) Rhythm analysis statements - c) Morphology analysis statements - d) Pacemaker pulse detection and Pacemaker rhythm diagnosis - e) Provide multiple diagnostic outputs for a single ECG, if it contains multiple diagnostic findings - · Patient cable with D-sub 15 pin connector and 4.0 mm plugs is used for recording 12-Lead resting ECG with the device. - · ECG electrodes are not provided with the device (Kenz Cardico 1211). Disposable chest/limb electrodes connected to the ECG Adaptor Clips of the plug size 4.0 mm are compatible with the Kenz Cardico 1211.