M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 8 -
1.2.7 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary
precautions in accordance with local laws and regulations and institution’s policies. EDAN
recommends health care organizations or medical institutions to implement a comprehensive and
multifaceted strategy to protect the information and systems from internal and external security
threats.
To ensure the patients’ safety and protect their personal health information, the user should
implement security practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
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 monitor is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.
3 Ensure that the data are deleted after the patient is discharged. (Refer to Section 4.6
Data Management).
4 Ensure that the monitor is connected only to the device authorized/approved by
EDAN. Users should operate all EDAN deployed and supported monitors within
EDAN authorized specifications, including EDAN approved software, software
configuration, security configuration, etc.
5 Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s
service personnel are allowed to modify the Factory Maintain settings.
6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
7 When the monitor 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 monitor. (Refer to Section 4.6 Data Management).
8 Please protect the privacy for the information and the data displayed on the screen,
and for the information and the data stored in the monitor.
9 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.
10 Dos and DDos protection of the router or switch must be turned on for defensing
against attacks.
To Next Page
Loading...
Need help?
General
