Cardionica
1Pages

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TECHNICAL datasheet PRODUCT -Cardionica REF -91200000 Indication for use Cardionicais a medical device that detects atrial fibrillation episodes through a single-lead electrocardiogram (EKG) with the adhesive electrode placed on the chest. Its use is intended forhealthcare operators or adults who want to check the presence of atrial fibrillation episodes. Storage/shipping conditions Operating conditions Humidity: Altitude Applied norms Shelf life Technical specification Main body Width Length Thickness Weight Patch CardioDot Reusable patch (code 912002) Accelerometer Power supply Current capacity Consumption Autonomy Connectivity Display Keyboard Leds Type of electrical protection Safety level for shock hazard Conditions of use Tri-axial accelerometer Lithium 3V (CR2032) 210 mAh max ~8 mA (during archive sharing) 300 uses or 2 years Bluetooth® 5 ready none none Green Orange Red Internally powered Type BF Apparatus Apparatus for continuous use How to use EKG EKG lead Input differential range Frequency response Common mode rejection ratio DC offset correction Input impedance Sampling rate Resolution Memory capacity Measured parameters IEC 60601-1:2005 + A1:2012 EN 60601-1-2:2015 EN 60601-1-6:2010 EN 60601-1-9:2013 EN 60601-1-11:2015 EN 60601-2-47:2012 ISO 10993-1:2018 Cardionica 5 years Patch 2 years Stand alone Connection with App Cardionica (iOS, Android) single lead ±6.25 mV 0.167 Hz to 30 Hz 100 dB @50Hz ±300 mV > 10 MOhm 250 S/s 18 bit; 0.048 uV 100 ECG, 1 minute each Atrial fibrillation, bradycardia or tachycardia episodes Heart rate (bpm) only with App Cardionica Available in pdf mode via App Cardionica Available as edf file via App Cardionica Certificates & Registrations CE 0476 CND code GMDN code Ministry of Health (Italy) USA MIR USA, Inc. 5462 S. Westridge Drive New Berlin, WI 53151 Phone +1 (262) 565-6797 Fax +1 (262) 364-2030 Class IIa MED 9826 (MDD 93/42/CE) Z12050301 (Cardionica) C020501 (CardioDot) 62641 (Cardionica) 42489 (CardioDot) 2205399 FRANCE MIR Local Office Jardin des Entreprises, 290, Chemin de Saint Dionisy 30980 LANGLADE (France) Phone +33 (0)4 66 37 20 68 Fax +33 (0)4 84 25 1

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Cardionica
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Cardionica 1Pages

Catalog excerpts

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Cardionica
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