Cubeholter WS
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Cubeholter WS General Information Product name Generic name Product code Cardioline Spa Head Office and Production facility: Via Linz, 151 38121 Trento Italy Cubeholter WS is a software system for importing, analysing and reporting Holter ECG traces, acquired by means of Walk400h and Clickholter recorders, with sampling rates from 250 to 1000 Hz and recording duration from 1 to 7 days. Cubeholter WS creates a complete ECG Holter local work station where it is possible to prepare the Holter recorder, download the test, analyse it, review it and store it locally. It can be used with Cardioline connectivity software to manage a complex workflow, which allows you to receive and use work lists, receive tests remotely for reviewing, send PDF reports of the tests provided to Cardioline ECGWebApp. The software consists of the following main functions: 1) Downloading and storing recorded tests. By connecting the Holter recorder, any recorded tests and patient data are downloaded to the computer in a local archive. Patient data can also be imported from GDT files. Test analysis and creation of specific parameters. The software performs a series of automatic analyses on the downloaded test: recognition and removal of artefacts, heartbeat recognition, heart rate and Atrial Fibrillation analysis, pattern generation, recognition and classification of supra-and sub-ventricular arrhythmias, ST analysis, QT/QTc analysis, HRV analysis and pacemaker analysis. Holter test display and reviewing. By using a display, it is possible to view the entire ECG Holter test and the results of the analyses referred to in the previous point, change its parameters and review it, creating the relevant PDF report. Preparing the recorder and entering patient data. By connecting the Holter recorder, it is possible to enter the patient’s data and set the recording parameters. Exporting the PDF and GDT Holter report. The Holter report can be exported in PDF and GDT format.

Technical Specifications Minimum Requirements for Work Stations Operating System Intel core i5 or higher More than or equal to 8GB Free space on Hard Disk At least 2GB for the program plus the space for the archive 16:10 form factor @ 1600x1050, 22” or more (100% resizing) 16:9 form factor @ 1920x1080, 15.4” or more ( >= 125% resizing) Maximum recommended resolution: 4096×2160 (4K) Safety Standard Tests archive Archive type Local database Archive capacity 1,000 tests (recommended limit) Compatible devices Patient data Test parameters  Patient cable: 5, 7 or 10 wires;  Recording duration:...

Final report Customisable final report:  Header;  Summary per page;  Glossary: multiple editable glossary available for therapy, anamnesis, diary and signature fields;  Template: configurable multiple result template, to automatically add fixed text with variable tags based on the exam outcome. The available tags are as follow: o Datelenght, Beats, HR med, HR min, HR max, Afib, Bradycardia, SVT, VT, Pause, VEvents, SVCEvents.  Print reservations;  Data: o Trend: RR/HR, Events, ST, QT, HRV; o Tables: RR/HR, Events, ST, QT, HRV; o ECG: RRmax/RRmin, HRmax/HRmin (manually editable), Event...

Supraventricular tachycardia Ventricular couplets Ventricular tachycardia Bigeminy Trigeminy Pause Junctional rhythms Capture fault (if pacemaker analysis is active); Sensitivity fault: oversensing (if the pacemaker analysis is active); Sensitivity fault: undersensing (if the pacemaker analysis is active). Possibility to manually add Bundle Branch block, Ventricular R on T, Interpolated, Fusion events.  Measurements by means of callipers (duration and amplitude);  Entering, removing and editing beats and events: o Enter/edit an event; o Enter, edit or remove a heartbeat; o Report the...

 Modification of template type;  Removal of a template or beat in the selected template Event Window Display parameters  Interval displayed;  Display type: trend, table or strips;  Averaged leads view (in strips view): configurable channel 1 and/or channel 2 and/or channel 3, compact or expanded view;  Duration of the interval to be analysed: complete, 12h, 6h;  Events displayed: SVEB, DEL, SVS, SVT, NOR, APB, AAB, BRA, AR, AT, ASVT, AFLU, AFIB, VEB, ESC, CPT, IVR, AIVR, VT, BYG, TRI1, TRI2, VFLU, VFIB, QUAD, JPB, JR, AJR, PAU, more manual events BBB, RonT, Interpolated and Fusion. ...

Transfer of recordings for remote Optional (via Cardioline WebUploader and WebReceiver software) reviewing Transmission of PDF reports to Optional (via Cardioline WebUploader software) Cardioline ECGWebApp Regulations and Safety Classification according to MDD 93/42/EEC Class Rule 10 annex IX Directive 93/42/EEC and its amendments Notified Body Classification according to FDA Classification Product Code: Review Panel: Regulation Number: Classification according to IEC 62304 – Software Class of risk Performance Standard Other classifications GMDN 36827 Electrocardiograph, Holter analyser...

Clickholter (old model) – v. 1.0 and onward Compatible Devices Leaflet USB protection key USB connection cable CD ROM with Cubeholter software Software back-up USB key