EDAN iSe Series User Manual page 26

iSE Series Electrocardiograph User Manual
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 device.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
1. The access/operation of the electrocardiograph is restricted to authorized
personnel only. Assign only staff with a specific role the right to use the
electrocardiograph.
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 electrocardiograph is connected only to the device
authorized/approved by EDAN. Users should operate all EDAN deployed and
supported electrocardiographs
including EDAN
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. Add the master computer software to the whitelist.
7. Dos and DDos protection of the router or switch must be turned on for
defensing against attacks.
8. When building the networking environment: 1) If a wireless router is used,
please turn on the MAC address filtering function of the wireless router and add
the MAC address of the electrocardiograph to the rule list. The wireless router
only allows devices in the rule list to access the wireless network. 2) It is
CAUTION
within
approved software,
EDAN authorized
software configuration,
- 20 -
Introduction
specifications,
security