touchECG System Digital Premium
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touchECG System conf. DIGITAL PREMIUM General Information Product Name touchECG System conf. DIGITAL PREMIUM Generic Name touchECG System conf. DIGITAL PREMIUM Product Code Cardioline Spa Registered Office and Production: Via Linz, 151 38121 Trento Italy Sales Office: Via F.lli Bronzetti, 8 20129 Milan Italy Diagnostic electrocardiograph with 15 simultaneous leads (12 + Frank); solid, stable when transported, with long autonomy, suitable for intensive use in wards. Wireless ECG acquisition device, light, durable, comfortable for the patient and practical for the operator. Wide colour touch-screen display for fast and intuitive operation, even with gloves on. Integrated high-resolution thermal printer. Automatic, scheduled, manual and emergency (STAT) acquisition. Continuous acquisition for up to 30 minutes with the option to select the traces of interest. Automatic interpretation through the University of Glasgow algorithm with specific criteria depending on age, gender and race. X, Y, Z Frank leads and VCG Loops. LAN and WiFi connectivity for complete, two-directional communication with HIS and PACS in SCP, PDF-GDT-XML format. Internally generated DICOM, DICOM and HL7 protocols. The integrated thermal printer operates with pack paper (A4 and letter formats) and supports the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channels in automatic mode and 3, 6 or 12 printing channels of rhythm strip. The handy cart has a support arm for the display with 3 degrees of freedom, for optimum viewing. Technical Specifications General characteristics Equipment and features Wheeled Digital Premium Electrocardiograph touchECG software Wireless HD+ acquisition unit A4 format integrated thermal printer Silicone keyboard that can be sanitised and fully cleaned by immersion

Roll Stand Support arm for the Touch-Screen Display Supporting surface for mouse and keyboard (dimensions: 520 x 150 mm, height 900 mm) Extensible support for the printed paper 2 x fixed wheels Ø 150 mm, 2 x swivel casters Ø 100 mm with parking brake. Cable arm: optional Barcode reader: optional Magnetic badge reader: optional Suction-cup electrode system: optional Large storage compartment with 2 shelves protected by a door with lock ECG acquisition (HD+ unit) ECG leads Patient Cable 10 wire replaceable patient cable Front-end sampling rate Sampling rate for signal analysis Dynamic range...

Sampling rate Digital high pass linear phase filter, diagnostics (compliant with 60601-2-25 2nd ed) Digital AC interference adaptive filter 50/60 Hz Digital low pass filter 25/40/150 Hz (for printing and display)    Automatic (15 leads simultaneously), Manual (3/6 leads without time limits), Review (12 leads); records traces on Event Marker (Bookmark function) Timed (Auto-Bookmark function) Lead configuration Standard, Cabrera, Frank All leads, medians, corrected: HR RR Medium PR Interval QRS Duration QT and QTc intervals (Hodges formula) QTc Bazett interval QTc Fridericia interval max...

Manual print formats Calibration signal Lead identifier Printer Technology Vertical 8 dots/mm Horizontal 203, 254 and 508 dpi A4, Z-fold letter thermal paper Power supply Integrated medical AC power-supply unit and internal rechargeable battery Power supply unit input voltage Power supply unit input current Power supply unit input frequency Power supply unit protection rating Battery type Battery autonomy Over 2 hours continuous printing or more than 500 ECGs Battery recharging time 4 hours until 85% of total capacity User interface LEDs indicating status, connected power supply and battery...

Rule 10 annex IX Directive 93/42/EEC as amended Notified Body GDPR Compliance (General Data Protection Regulation) Access control Through the use of username and password at Operating System level and installing one instance of touchECG for each user (each one with its own database, which only the corresponding user can access). Data at rest protection When the system administrator activates the encryption features of the operating system. Audit trail Through the Windows operating system log, which keeps track of operations performed on the system. Patient data removal (right to be...

RDM (Medical Device Catalogue) Medical devices - Symbols to use in labels of the medical device, in the labelling and in the information which must be supplied - Part 1: General requirements Information supplied by the manufacturer of medical devices Medical devices - Quality management systems - Requirements for regulatory purposes Medical devices - Application of risk management to medical devices Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Medical electrical equipment - Part 1: General requirements for basic safety and essential...