Cardioline ECG100+ - Audit Trail and Operator Action Logging

ECG100+ - ECG200+ - ECG100S - ECG200S
9. SET THE DEVICE IN ACCORDANCE WITH GDPR (General Data Protection Regulation)
At startup, the device works in anonymous access mode. To enable the full access mode, insert an NFV
reader into the USB socket, with which to scan an adequately configured NFC card.
Similarly, after a period of inactivity, the device automatically returns to the anonymous access mode and
full access is restored by scanning the NFC card again.
An open/closed padlock icon indicates the active access mode.
NOTE: NFC cards must be previously configured in order to be read by the reader and enabled for full access.
9.3. Audit trail
The device logs the operations performed by the operator on the device itself and saves them in a protected
memory area, stored for at least 12 months
The file shows:
 Operator ID (‘?’ if the operator is anonymous);
 Date and time of the operation (YYYY-MM-DD HH:mm:ss);
 The identification label of the event;
 Additional data, if applicable.
The logged events are:
 User authentication (USRAUTH);
 Work List Opening (WORKLST);
 Archive opening (ARCHIVE);
 Opening of a test in the Archive (OPENEXM): the patient name, patient ID and test date/time are
also shown;
 Printing of a test (PRNTEXM): the patient name, patient ID and test date/time are also shown;
 Transmission/sending of a test (LINKEXM): the patient name, patient ID and test date/time are also
shown;
 Exporting a test via USB (EXPTEXM): the patient name, patient ID and test date/time are also shown;
 USB connection to a PC (USBCONN);
 Switch to Anonymous Access mode (ANONMOD).
If the same operation (e.g. test transmission) is performed on multiple tests simultaneously, an event is
logged for each test.