Chapter 1 - Warnings and cautions
1.8 Maintaining information security
WARNING
Do
NOT
connect this equipment with any other equipment not provided in the accessory
kit.
Do
NOT
use any cables, adapters, or products that are not provided or approved for the
device as this may result in non-compliance.
WARNING
IT networks used by medical devices
Connection of the P200TxE device to an IT
NETWORK
/
DATA COUPLING
that includes other
equipment could result in previously unidentified
RISKS
to
PATIENTS
,
OPERATORS
or third
parties.
The
RESPONSIBLE ORGANIZATION
should identify, analyze, evaluate and control these
RISKS
.
Subsequent changes to the IT
NETWORK
/
DATA COUPLING
could introduce new
RISKS
and
require additional analysis, and changes to the IT
NETWORK
/
DATA COUPLING
.
These include:
l
changes in the IT
NETWORK
/
DATA COUPLING
configuration
l
connection of additional items to the IT
NETWORK
/
DATA COUPLING
l
disconnecting items from the IT
NETWORK
/
DATA COUPLING
l
update of equipment connected to the IT
NETWORK
/
DATA COUPLING
l
upgrade of equipment connected to the IT
NETWORK
/
DATA COUPLING
.
CAUTION
The scan head and image server should be kept in a secure location. You are
responsible for maintaining the security of information stored on the scan head and
image server.
You are responsible for the security of user accounts and the maintenance of password
security.
1.9 Data security
CAUTION
Your System Administrator is responsible for backing up the image server. Backups
MUST
be verified regularly to avoid patient data loss.
Only allow authorized personnel to access the data. Changes to data may lead to
incorrect diagnosis.
Implement measures to protect personal patient data from misuse.
If a critical error occurs during capture you should review the saved images and scans,
and recapture scans and images if necessary.
Exit Optos
Advance
before turning
OFF
the image server.
You can install critical Windows Updates and anti-virus signatures on the Image Server
PC and Viewing PCs by following the instructions displayed during the update.
Page 18 of 84
Part Number: G110230-003-ENG
English
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