SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance
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To ensure the patients’ safety and protect their personal health information, the user should
implement practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the ABPM.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the ABPM is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the ABPM.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure (i.e. cannot remove without tools).
3 Ensure that the ABPM is connected only to the device authorized/approved by EDAN.
Users should operate all EDAN deployed and supported ABPMs within EDAN
authorized specifications, including EDAN approved software, software configuration,
security configuration, etc.
4 Protect all the passwords to prevent unauthorized changes.
5 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
6 Firewalls and/or other security devices should be in place between the medical
system and any externally accessible systems. Firewalls and/or other security
devices should be in place between the medical system and any externally accessible
systems. It’s recommended to use Windows defender firewall or any other firewall that
can defend against Dos and DDos attacks, and keep it up to date.
7 When the ABPM is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, it is necessary to ensure that all patient data are
removed from the ABPM.
8 Please protect the privacy of the information and data displayed on the screen, and
those information and the data stored in the monitor.
9 It is recommended that you activate Windows password strategy.
10 Users should make a backup of data on a periodic basis.
11 Install security software, anti-virus software, and activate firewall and auto updates.
Run the anti-virus software on a regular basis. Add the master computer software to
the whitelist.
12 Disable unnecessary services from the operating system and reduce vulnerabilities.
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