*mymedicalexpo

Cardionica

Product catalog summary

Product Overview
Cardionica is a medical device designed to detect atrial fibrillation episodes using a single-lead electrocardiogram (EKG) with an adhesive electrode placed on the chest. It is intended for use by healthcare operators or adults monitoring atrial fibrillation.

Technical Specifications

Main Body: Width 15 mm, Length 57 mm, Thickness 37 mm, Weight 20 g (battery included)
Patch: Reusable CardioDot (code 912002)
Power Supply: Lithium 3V (CR2032), Current capacity 210 mAh, Max consumption ~8 mA
Connectivity: Bluetooth® 5 ready
Indicators: Green, Orange, Red LEDs
Safety: Type BF Apparatus, Internally powered
Conditions of Use: Continuous use, Storage temperature -25°C to +70°C, Operating temperature +5°C to +40°C, Humidity 10%-90% RH
Altitude: < 3000 m

Compliance and Standards

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

Usage and Connectivity

Standalone use or connection with Cardionica App (iOS, Android)
EKG lead: Single lead, Input differential range ±6.25 mV
Frequency response: 0.167 Hz to 30 Hz
Common mode rejection ratio: 100 dB @50Hz
Memory capacity: 100 ECGs, 1 minute each
Measured parameters: Atrial fibrillation, bradycardia, tachycardia episodes, Heart rate (bpm) with App
EKG report available in PDF via App
EKG data available as EDF file via App

Certificates & Registrations

CE 0476 Class IIa MED 9826 (MDD 93/42/CE)
CND code: Z12050301 (Cardionica), C020501 (CardioDot)
GMDN code: 62641 (Cardionica), 42489 (CardioDot)
Ministry of Health (Italy) 2205399

Catalog excerpts

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

Open the catalog to page 1

All MIR - Medical International Research catalogs and technical brochures

Archived catalogs

MIR Spirobank OXI
1 Page
FlowMir
2 Pages
FlowMIR®
1 Page
Smart One
1 Page
Spirobank Smart
4 Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

Brand list