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1.
Introduction
The medical device is a Personal device for CARDiac activity (PCARD), named and referenced as
SAVVY in the remainder of the document. The SAVVY medical device constitutes from a as Savvy
sensor, charger, charging dock and mobile application (MobECG). The core of the system is a
small and light (21g) Savvy sensor, fixed to the skin using standard self-adhesive electrodes. The
Savvy sensor measures the user's differential ECG between two proximal electrodes on the
distance of approx. 8,5 cm. The moderate resolution ECG is suitable for long-term personal
cardiac activity monitoring during every-day or sport activities, and for clinical use. With a single
charge of the built-in battery, the Savvy sensor can run continuously for up to seven days and
at least 14 days in stand-by mode. The SAVVY sensor can be recharged using a charging dock
station that comes with it. The measurements from the Savvy sensor are transferred through a
build-in low power Bluetooth BT4.0 radio to the mobile application on a personal digital
assistant (PDA), i.e. smartphone or tablet, which provides storage and graphical presentation
of the measurements. User can be a healthy person, person under screening or a patient. The
usage of the MD is not limited by age, sex, body weight or height and other personal
characteristics.
A Patient can generate ECG REPORT on mobile device in PDF format, which can be printed out
or sent by e-mail to the patient Doctor for further diagnose.
2.
Terms and conditions
1. Manufacturer and distributor Saving d.o.o., Finžgarjeva 4, Ljubljana, has, with the
participation of the Jozef Stefan Institute in Ljubljana, developed the device with the
commercial designation Savvy, in accordance with technical data which is an integral part of the
user manual of the device.
In accordance with Directive 93/42/EEC on medical devices with a valid amendment, Directive
2007/47/EEC, the developed device is intended to monitor cardiac activity in everyday life, and
accordingly with the introductory Directives classified as an active non-invasive medical device
labeled IIa.
Medical device Savvy is intended for daily individual use of potential buyer, user, for heart
activity monitoring through a single-channel recording of ECG.
Medical device is not intended for a treatment and is not a diagnostic tool in accordance with
the rules of the medical profession, as it is stated in the second paragraph of this document
(Directive
EEC).
In the event that the user feels uncomfortable with regard to cardiac function, he must urgently
seek medical assistance, regardless of the conditions shown by the medical device Savvy.
2. Medical device Savvy cannot function independently. It is directly wirelessly connected to a
smartphone or tablet, provided it is in the immediate vicinity. Measured conditions of cardiac
activity are transmitted to the memory unit with the specific program.