touchecg

www.cardioline.it

General overview

Touchecg is a new concept 12-lead electrocardiograph based on tablet PC, touch screen and easy-to-use wireless patient cable. The user-friendly interface of Touchecg makes it an easy and quick electrocardiograph, comfortable both for the patient and the user, while ensuring high-quality waveforms. The excellent portability of Touchecg, also ensured by the carry case provided, makes it the ideal device for active professionals. In a clinical environment or in the doctor's office, the electrocardiograph can be mounted on a smart design cart with an accessory holder basket. Touchecg supports HD+ wireless acquisition module; equipped with new generation technology, HD+ acquires diagnostic 12-lead ECG waveforms meeting or exceeding the strictest standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). Moreover, by implementing Glasgow interpretation algorithm, Touchecg is a complete, highly technological device while keeping compact, user-friendly features. The powerful settings of Touchecg makes it the first electrocardiograph able to communicate directly

with a Cloud archive with no need to connect to a PC network, leaving record management problems behind. Several connection options and the variety of protocols supported allow for the integration of ECGs in any flow of clinical data, archives or local management systems, hospital PACS etc., through the DICOM standard. Touchecg can be connected to a convenient A4 wireless printer for printing waveforms in different formats. Touchecg: the way Cardioline makes mobile computing a useful tool for professional physicians.

Main features

A new generation, up-to-date electrocardiograph based on touch screen tablet PC.

Wireless acquisition for maximum patient comfort, safety and quick use.

Extremely high signal quality, very low noise. Exceeds the strictest international standards.

New, highly sophisticated technology for unrivalled pacemaker recognition.

It employs Professor Peter Macfarlane's Glasgow Program for automated ECG analysis, the only interpretive program developed in hospital, with real patients, instead of a University laboratory or an enterprise.

This algorithm widely employs age, gender and race specific criteria. It adapts to every patient age, from birth to adulthood and old age. It is

able to differentiate infant age in term of days and use precordial V4R if required.

This is the first program using gender and age specific criteria in STEMI diagnosis, dramatically increasing both the sensitivity and the specificity of the algorithm.

This is the first "Cloud enabled" electrocardiograph worldwide, allowing physicians to have their patients’ exams ready at hand, without the trouble of managing a local archive.

It can be perfectly integrated in DICOM patient data flow within the hospital site.

It also exports ECGs in SCP, PDF, GDT, Jpeg, Png format, making data compatible with any management system.

www.cardioline.it

Technical specifications

Operating systems .......................... Windows 7 pro, Windows 8 pro, 32/64 bit

Acquisition ...................................... 10 s automatic, manual, 10 s excerpts buffer

Display ............................................ 6 or 12 leads, user-selectable lead speed and lead width

Printing formats .............................. A4, with a variety of custom formats available.

Automatic ECG analysis .................. The University of Glasgow Interpretive Program

Waveform storage .......................... Local, web or Cloud

Export formats ................................ SCP, GDT, JPEG, PDF. DICOM (optional)

Worklist .......................................... Worklist management according to the DICOM standard

HD+ Acquisition Module

ECG leads ........................................ 12 leads (I, II, III, aVR-L-F, V1-6)

CMRR.............................................. 115 dB

Sampling rate.................................. 1000 samples/second/channel for analysis and storage

A/D conversion ............................... 24 bit

Data resolution ............................... 20 bit, < 1uV/LSB

Input range ..................................... +/-400mV @ < 1uV/LSB

Bandwidth ...................................... 0.05 – 300 Hz

Defibrillator protection ................... AAMI/IEC standards

Pacemaker detection ...................... Hardware detection coupled with convolution digital filtering

Lead fault detection ........................ Independent on every lead

Wireless system .............................. Bluetooth 2.0

Patient cable ................................... 10 wires, single connector

Power on ........................................ 1 programmable key

Batteries ......................................... 2 x standard AAA

Dimensions ..................................... 115 x 65 x 15 mm

Weight ............................................ < 90 g with batteries

Water resistance ............................ IP 40 / IP 42 with silicon cover

Shock protection............................. Fall from a height of 1 m on any side

Headquarters Via De Zinis, 6

38011 Cavareno (TN), Italy T. +39 0463 850125 F. +39 0463 850088

Operations

Via F.lli Bronzetti, 8 20129 Milano, Italy

T. +39 02 94750470 F. +39 02 94750471

HD+

www.cardioline.it

General overview

HD+ is a wireless ECG acquisition module, to be primarily used as common ECG front-end for PC/tablet (Windows/MAC OS/other) standard platforms (both for Resting ECG and Stress ECG applications). HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead ECG data over a proximity range, providing perfect electrical insulation and freedom of movement for the patient. HD+ is light and compact, comfortable to wear, minimizing motion artifacts caused by traditional electrodes and patient cables. HD+ offers uncompromised, full diagnostic ECG acquisition – meeting or exceeding the most severe standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). HD+ uses a LED indicator to comfortably monitor the link status (off when unit is powered down, blinking when unit is attempting to connect with the receiver, steady when unit is connected with the receiver). HD+ uses a programmable key to send macro commands to the receiving system (i.e. acquire and print an ECG).

Low-power technology allows continuous usage of the device for more than 10 hours (from full battery charge).

Main features

Confortable, lightweight, wireless full diagnostic 12 lead acquisition unit,

Extremely high signal quality, very low noise. Exceeds the most severe standards for ECG acquisition (AAMI, ANSI, AHA,ACC)

Highly sofistcated technology for optimal Pace Maker recognition

Extremely easy to use, 1 button, 1 led Water and dust protected and drop proof (1 mt) Low power consumption technology allows more

than 10 hours (or more than 500 ECGs) continuous usage

To be used with Cardioline Touch ECG and Cardioline HD+ stress

www.cardioline.it

Sede legale Via De Zinis, 6

38011 Cavareno (TN), Italy T. +39 0463 850125 F. +39 0463 850088

Sede commerciale

Via F.lli Bronzetti, 8 20129 Milano, Italy

T. +39 02 94750470 F. +39 02 94750471

Technical specifications

Operating systems compatible.............. Windows 7 pro, Windows 8 pro, 32/64 bit

ECG channels ........................................ 12-lead (I, II, III, aVR-L-F, V1-6)

CMRR.................................................... 115 dB

Sampling frequency .............................. up to 1000 samples/second/channel for analysis/storage

A/D conversion ..................................... 24 bit

Output data resolution ......................... 20 bit, < 1uV/LSB

Input range ........................................... +/-400mV @ < 1uV/LSB

Bandwidth ............................................ up to 0.05 – 300 Hz, according to sampling frequency

Defibrillator protected .......................... AAMI/IEC standards

Pacemaker detection ............................ hardware detection coupled with convolution digital filtering

Electrode fail detection ......................... independent on all electrodes

Wireless data transfer........................... Bluetooth 2.0+ with secure pairing

Electrode cables ................................... 10-wire, single connector, replaceable

Action key ............................................. 1 key, programmable by user/application

Battery .................................................. 2xAAA standard cells

Dimensions ........................................... 115 x 65 x 15 mm

Weight .................................................. < 90 g with batteries

Water resistance .................................. IP40 / IP42 with silicone shell

Shock .................................................... 1 m any edge, corner or surface

Certification CE0476

sp_hd+_cardiolinespa_01_eng.docx 24/07/2014

The Glasgow Program for ECG Interpretation

www.cardioline.it

General overview

The Glasgow program, available from Cardioline, is intended to provide an interpretation of the resting 12-lead ECG in all patient care situations, whether this be in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, ST-T abnormalities and common abnormalities of rhythm. Conduction defects and other abnormalities such as prolonged QT interval are also reported. The Glasgow 12-lead ECG Analysis Program, is the product of decades of research and continuous improvement by Professor Peter W. Macfarlane, D.Sc, FESC, and colleagues at the University of Glasgow. A database of ECGs from healthy neonates, infants and children was established in Glasgow many years ago. This led to the development of criteria for

interpretation of the ECG from individuals in that age range. The neonatal ECG is very different from that of the adult and different criteria are essential. With the use of the Glasgow normal database and ECGs from patients with known myocardial infarction, the Glasgow criteria were adapted to obtain maximum sensitivity and specificity in the diagnosis of acute ST elevation myocardial infarction (STEMI). The criteria are not only age/sex dependent but lead dependent. Indeed, they vary within one lead

for adult males and females Versions of the Glasgow ECG analysis program have been adopted commercially initially by Siemens Elema, based in Stockholm, Sweden (now Draeger Medical, Andover, Massachusetts, USA), by Burdick of Deerfield, Wisconsin, USA (now owned by Cardiac Science Corporation of Seattle, Washington, USA), and by Spacelabs Healthcare, of Issaquah, Washington, USA, by Phisio-Control, Redmond, USA, in the area of emergency, and lately by Cardioline (Italy).

Main features

Unique Program of its kind that has been developed within a hospital environment rather than a factory or University.

Makes widespread use of age and sex in clinical criteria. Has the ability to cope with patients of all ages from birth to old age. The age criteria for neonates is detailed at the level of days. Can utilize V4R for neonates and children. Makes use of race as well.

Leads the way in the use of age/sex based criteria for diagnosing STEMI

Uses clinical information if available Utilises drug therapy if known Critical Values statements highlights ECG findings

that may require immediate attention. Offers short diagnostic statements for the

hospital market or longer statements with reasons mainly for the primary care market

Meets all the IEC 60601-2-51 requirements. Is still under active development, meeting the ISO 9001 standards.

Thresholds for ST elevation in lead V3

The Glasgow Program for ECG Interpretation

www.cardioline.it

Bibliography

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25.Macfarlane PW, Browne D, Devine B, Clark E, Miller E, Seyal J, Hampton D. Modification of ACC/ESC criteria for acute myocardial infarction. J Electrocardiol. 2004;37(suppl):98-103. 26.Macfarlane PW, Browne D, Devine B, Clark E, Miller E, Seyal J, Hampton D. Effect of age and gender on diagnostic accuracy of ECG diagnosis of acute myocardial infarction. In: A.Murray, ed. Computers in Cardiology. 2004;31:165-168. 27.Macfarlane PW, Hampton DR, Clark E, Devine B, Jayne CP. Computer and cardiologist diagnosis of ST-elevation myocardial infarction. J Electrocardiol. 2007;40(suppl 1):S32-S33. 28.Sgarbossa EB, Pinski SL, Barbagelata A, Underwood DA, Gates KB, Topal EJ, Califf RM, Wagner GS. Electrocardiographic diagnosis of evolving acute myocardial infarction in the presence of left bundle-branch block. N Engl J Med. 1996;334:481-487. 29.Tabas JA, Rodriguez RM, Seligman HK, Goldschlager NF. Electrocardiographic criteria for detecting acute myocardial infarction in patients with left bundle branch block: a meta-analysis. Ann Emerg Med. 2008;52:329-336. 30.Macfarlane PW, Devine B, Clark E. The University of Glasgow (Uni-G) ECG alalysis program. Computers in Cardiology. 2005;32:451-454. 31.The CSE Working Party (incl. Macfarlane PW). Recommendations for measurement standards in quantitative electrocardiography. Eur Heart J. 1985;6:815-825. 32.Bailey JJ, Berson AS, Garson A, Horan LG, Macfarlane PW, Mortara D, Zywietz C. Recommendations for standardization and specifications in automated electrocardiography: bandwidth and digital signal processing. Circulation. 1990;81:730-739. 33.Willems JL, Arnaud P, van Bemmel JH, et al, incl. Macfarlane PW. A reference database for multilead electrocardiographic computer measurement programs. J Am Coll Cardiol. 1987; 10:1313-1321. 34.Willems JL, Arnaud P, van Bemmel JH, Degani R, Macfarlane PW, Zywietz C, for the CSE Working Party. Common standards for quantitative electrocardiography: goals and main results. Methods Inf Med. 1990;29:263-271. 35.Wagner G, Lim T, Gettes L, Gorgels A, Josephson M, Wellens H, Anderson S, Childers R, Clemmensen P, Kligfield P, Macfarlane P, Pahlm O, Selvester R. Consideration of pitfalls in and omissions from the current ECG standards for diagnosis of myocardial ischemia/infarction in patients who have acute coronary syndromes. Cardiol Clin. 2006;24:331-342. 36.Kligfield P, et al, incl. Macfarlane PW. Guidelines for the standardization and interpretation of the electrocardiogram, part 1: the electrocardiogram and its technology. Circulation. 2007;115:1306-1324. 37.Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Circulation. 2007;116:2634-2653. Also in: J Am Col Cardiol . 2007;50:2173-2195. Also in: Eur Heart J. 2007;28:2525-2538.

Sede legale Via De Zinis, 6

38011 Cavareno (TN), Italy T. +39 0463 850125 F. +39 0463 850088

Sede commerciale

Via F.lli Bronzetti, 8 20129 Milano, Italy

T. +39 02 94750470 F. +39 02 94750471

sp_Glasgow_cardiolinespa_01_eng.docx