Patient Monitor User Manual Intended Use and Safety Guidance
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precautions in accordance with local laws and regulations and institution’s policies. The
manufacturer 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 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 4.15
Data Storing).
4 Ensure that the monitor is connected only to the device authorized/approved by the
manufacturer. Users should operate the monitors deployed and supported by the
manufacturer within the specifications authorized by the manufacturer, including
these (such as software, software configuration, security configuration, etc.) approved
by the manufacturer.
5 Protect all the passwords to prevent unauthorized changes.
6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
7 When connecting the monitor to a shared network, data security issues of the network
topology and configuration must be considered. Since the patient sensitive data might
be transmitted from the monitor to the network, the medical institution should be
responsible for the network security. Firewalls and/or other security devices should be
in place between the medical system and any externally accessible systems.
8 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 4.15 Data Storing).
NOTE:
Log files generated by the monitor are used for system troubleshooting and do not
contain protected medical data.
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