User's Manual

SE-1200 Pro&SE-1201 Pro Electrocardiograph User Manual Safety Guidance
- 7 -
1.3.1 Protecting Personal Information
Protecting personal health information is a significant component of security strategy. To
protect personal information and ensure the proper device performance, the user should
take necessary precautions by local laws and regulations and institutional policies. EDAN
recommends health care organizations or medical institutions 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 does 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 the technical field