Product description: sp_walk400h_cardiolinespa_07_eng1.doc 1/2

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1 walk400h walk400h walk400h is a latest-generation holter recorder able to acquire and memorise from 3 to 12 ECG channels, compatible with the holter reader software CARDIOLINE, for details of which see the relevant documentation. walk400h is a micro-computer with highly evolved PC connectivity and extensive capacity to memorise and handle holter tests. The features which distinguish walk400h are: - large, colour, LCD graphic display visualises up to six ECG signal charts at the same time; - intuitive, basic user interface uses guided procedures to enable the operator to complete the test easily and rapidly; - wireless PC connection using bluetooth technology or, alternatively, via USB cable; - built-in voice recorder to memorise vocal messages during the test (event-marker function) and/or to insert patient details when preparing the test; - incorporated movement sensor to record the motor activity of the patient; - extensive data memorisation, capacity to handle tests lasting from one to seven days; - single, 5-position joystick to rapidly scroll the device menu; - limited size and weight for increased patient comfort; - functions with a single AA battery. The beat-beat acquisition of each ECG channel is performed at a minimum frequency of 250 samples per second per channel. For special analytic tests a higher sampling frequency may be chosen. All the ECG channels are recorded without interrupting the beat-beat acquisition of the signal and without any sort of signal compression. The recorder contains a flash memory of one GB thanks to which holter charts lasting a total of one week can be memorised Product description: sp_walk400h_cardiolinespa_07_eng1.doc 1/2 Cardioline S.p.A. Via De Zinis, Cavareno (TN) Italy info@cardioline.it Business office: Via F.lli Bronzetti, Milano (MI) Italy tel fax

2 walk400h Technical specifications Channels... configurable from 3 to 12 acquired channels acquired simultaneously and continuously Duration of recording... from 1 to 7 days (depending on the functioning mode) Sampling frequency , 1000 samples per second (depending on the functioning mode) Resolution... 14; 15 bit (depending on the functioning mode) Sensitivity (LSB) microV/bit; 5.0 microv/bit (depending on the functioning mode) Input signal range... AC: ±40mV Input signal range... DC: ± 400mV Frequency response Hz 150Hz Common mode rejection... > 90dB Time constant sec Saturation detection... performed for each channel Pacemaker recognition... hardware detection on 3 channels Connection to PC... wireless type Bluetooth Class II in real-time; USB cable to download the test Display... colour display for visualisation of ECG chart, quality of electrode/skin contact and messages for preparation and download of the test Display resolution... 2,2 ; 240x320dots; ¼ VGA Voice recorder... incorporated Event Marker... using keypad plus voice recorder Memory... 1 GB, incorporated in the device. LED... 1 green LED to check battery status; 1 blue LED to check system status Keys... 1 multi-function, 5-position joystick Patient cable... 5; 7; 10-wire cable with snap attachment Defibrillator protection... absent Power supply... 1 AA alkaline battery (ultra or rechargeable NiMh of at least 2500 mah) Dimensions... 96x65x20 mm Weight g (with battery) 80g (without battery) Housing protection category... IP 30 Applied parts... type CF Classification EEC Directive 93/42 IIa Classification (EN internally powered device Type CF PC Interface... Standard Bluetooth key or USB 2.0 Environmental operating conditions... temperature between +10 and +45 C relative humidity between 25 and 95 % (without condensation) atmospheric pressure between 700 and 1060 mbar Environmental storage conditions.. temperature between +10 and +45 C relative humidity between 25 and 95 % (without condensation) atmospheric pressure between 500 and 1060 mbar 0476 Product description: sp_walk400h_cardiolinespa_07_eng1.doc 2/2 Cardioline S.p.A. Via De Zinis, Cavareno (TN) Italy info@cardioline.it Business office: Via F.lli Bronzetti, Milano (MI) Italy tel fax

3 cubeholter cubeholter is the complete solution to manage Holter ECG tests. cubeholter combines all the typical procedures for the Holter test in a single application: from recorder management to downloading the test to a PC and automatically archiving it, from automatic analysis and review to printing out the final document and exporting it in electronic format. cubeholter can operate as a single workstation, or the database can be shared with other networked cube workstations. Description User Interface cubeholter makes the most of the graphic potential of Windows, guiding even inexpert users through the correct execution of all phases of the Holter test. Using menus, dedicated keys and guided procedures, working with cubeholter is extremely practical and fast. cubeholter consists of a several windows which can be used to monitor all program features at the same time: from simply displaying the trace in various formats to validating the automatic analysis and printing out the final document. cubeholter has five main windows, each designed to direct the attention of the operator to a particular aspect of the test: the RR window displays the RR tachogram, the dedicated trends for each type of arrhythmia. And offers an overall view of the test thanks to the colour coding and combined use and display of the ECG trace in compact, zoom or superimposed mode; the families window presents the results of the morphological analysis, grouping all complexes found during the Holter recording into classes. It thus represents the ideal tool for analysis editing, thanks to its speed and efficacy; the events window lists all the episodes detected, indicating the number and always allowing the user to evaluate them in context; the ST window focuses the operator s attention on ST and QT segment analysis. All the leads recorded may be displayed singly or together; the report window allows the user to write conclusions, configure the final document for printing, or select one of the configurations saved in the system and the proceed to print out the document. It is also possible to export the document to be printed out in electronic format, or to attach it automatically to an . A characteristic common to all the windows is their direct interaction with the ECG trace displayed on the screen: the change, enter or delete beat functions are always available, and may be applied to individual beats or groups of beats, as can the prebook printout, or direct printout functions. Changes may be made to the analysis using the mouse or dedicated keyboard keys. To speed up writing of the final report, each window is also provided with a free text area which can automatically be included in the final conclusions of the printed document. Use profile The operator can choose to use all the displays available in cubeholter or can select, to use only those that best meet his or her requirements and approach.

4 Automatic Analysis The efficiency and performance of the analysis algorithms, together with the calculation power of the latest generation of PCs, guarantee the accuracy of the analysis and allow the program to perform beat-beat analysis very quickly. Automatic analysis is based on classifying anomalies into event types and morphological families. cubeholter executes the following analyses automatically: - arrhythmia analysis; - family analysis; - independent ST and QT analysis for 3/12 channels; - analysis of variability in the time domain, - pacemaker analysis; - atrial fibrillation analysis. The automatic analysis algorithms are the fruit of over twenty years experience in analysing the Holter test, and of continual research for innovative solutions that perform the analysis algorithms have been validated on the MIT database. All the analysis, printout and display parameters can be customised and saved as system configurations, or a particular configuration can be defined for a single test. Saving tests cubeholter includes a dedicated database in which acquired tests can be saved and organised. cubeholter places the patient at the centre of the system, creating a virtual clinical record in which all the tests performed by cube workstations are automatically saved. From the first time the test is opened, cubeholter presents a complete and detailed report on the events detected. Managing tests cubeholter offers a system of predefined views of the database, accessed by dedicated icons on the toolbar: so the operator can quickly access the list of tests to report on, and read and sign each test. The program also includes a long term archiving function for the database, which allows tests that have already been analysed to be transferred to an external support (CD, DVD, etc.), maintaining the patient data and overall data on the archived test available online in the database. cubeholter also allows advanced searches to be made using the patient data, test or acquisition device as search parameters. Management of test preparation and downloading procedures cubeholter offers innovative management of the procedures to prepare tests and download them to the PC. The operator can use guided procedures to successfully and efficiently prepare both the recorder and the downloading of the test to the PC, managing the patient data correctly, entering the indications and treatment, programming the duration of the test and programming for pacemaker detection if required. Sharing the database with other cube stations cubeholter was designed with the capability to share its database with other cube workstations. This feature can be used to optimise work in a clinic or ward according to the specific clinical requirements of the individual physician. For example, workstations can be dedicated to downloading tests, and others to their analysis, or to the execution of different diagnostic techniques such as stress tests and rest ECGs

5 . Technical Specifications Analysis modes Interactive, with the possibility of analysing and reviewing the test by using lists of events, morphological families and trends, automatically preorganised by the software. Also available in superimposition mode. The analysis parameters may be configured and saved for each test. Colour coding Normal, ventricular, supraventricular anticipated, paused, pacemaker-stimulated noisy, aberrant, beats, left/right branch block. List of mains arrhythmias detected Morphological classifications Advanced RR analysis Analysis of ST and QT segment Pacemaker analysis. Print document VEB, SVEB, CPT, VT, SVT, SVS, BRA,DEL, AFIB, ESC; IVR, AIVR, PAU, DEL. Normal beats, ventricular beats pacemaker-stimulated, aberrant beats, left/right branch block. Atrial fibrillation, RR variability in the time domain Analysis of the ST segment and QT interval on all leads, with calculation of the amplitude and duration measurements, and evidence of episodes of depression and elevation. Recognition of atrial pacemakers, Ventricular, atrio-ventricular and fusion beats. Print document fully customisable. Possibility of saving a large number of models. Automatic archive function Export of final document Network connection Reception via internet archiving in the database, optional DVD backup in the SW package. Export and transmission by of final document in PDF or text format Can be networked and the database shared with other cube workstations. Using holterpilot., Holter traces can be received from peripheral workstations over the internet Registered office Via De Zinis, Cavareno (TN), Italy T F Sales Office: Via F.lli Bronzetti, Milan, Italy T F