Topcon ALADDIN HW3.0, User Manual

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ALADDIN
- User manual Rev. 19 EN of 10/07/2019
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4.8 Privacy & Cybersecurity

When performing the installation of a new unit the user MUST set his own credentials to prevent
unauthorized physical access to the device. To set up the access login to the instrument operation and
on-board data refer to section 13.7.

Make sure the USB devices you intend to connect to the instrument are secured against
malware/viruses.

Patient data on USB devices can become corrupted when inserting into computers for backup or
transfer.

The use of antivirus software on computers is recommended and it is responsibility of the user.

To protect data exported to USB from unauthorized access, use dedicated USB data for storage.

Installation of any unapproved software, including drivers, could degrade the performances of the
instrument and may void the instrument warranty.
4.8.1 Privacy
It is recommended that the operator understand the characteristics of this device in relation to Data
Protection.
Definitions and application within this device
Personal Data: means any information relating to an identified or identifiable natural person (‘data subject’);
an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to
an identifier such as a name, an identification number, location data, an online identifier or to one or more
factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that
natural person.
Personal Data used with the device is:

Subject identification data: subject name, subject date of birth, subject gender, subject ID (according
to the practise ID application policy). Refer to section 11.4 for further details on the management of
subject identification data.

Subject physical/physiological data: subject eyes biometric measurements, as acquired and stored in
each examination belonging to the subject. Refer to section 1.4 for further details on the types of
biometric measurements performed by the device.
Controller: means the natural or legal person, public authority, agency or other body which, alone or jointly
with others, determines the purposes and means of the processing of personal data.
The controller is the representative of the practise, clinic or hospital where the device is installed.
Processor: means a natural or legal person, public authority, agency or other body which processes personal
data on behalf of the controller.