Legenda Of Symbols; Support In Case Of Need And Adverse Event Reporting - D-Heart 4021 Manual De Instrucciones

7. LEGENDA OF SYMBOLS

The D-Heart Portable ECG Device
is certified according to the
relevant recommendations set
1370
by the European Community for
electromedical devices (93/42/
CEE). The number "1370" identifies
the notified body that verifies the
compliance of the device to the
applicable essential requirements.
Separate collection for Waste of
Electric and Electronic Equipment
(WEEE).
The D-Heart Portable ECG
Device supports the Bluetooth®
technology.
Range of temperature.
Range of humidity.

8. SUPPORT IN CASE OF NEED AND ADVERSE EVENT REPORTING

Please consult the following web site: https://www.d-heartcare.com/contact
for assistance, if needed, in setting up, using or maintaining the D-Heart Portable ECG Device or to
report unexpected operation or events.
Adverse event should be reported. Reporting form and information can be found at
http://www.salute.gov.it. Adverse events related to D-Heart Portable ECG device should also be
reported to D-Heart Srl on 0039 010 3017000
10
User Manual Smartphone ECG Device
The D-Heart Portable ECG Device
is protected against water and dust
with the level of protection IP22 as
defined by the IEC standard 60529:
•
The enclosure provides
protection to access to
hazardous parts for Fingers or
similar objects
•
The enclosure provides
protection to Dripping water
when tilted at 15°
Manufacturer.
The D-Heart Portable ECG Device
is classified as TYPE CF regarding
the protection against electrical
shock according to standard CEI
EN 60601-2-25.
Range of atmospheric pressure.
Keep dry: store and use the device
in a dry environment.
D-Heart