Product Information

SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance
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1 It is suggested that the user should not start ambulatory BP measuring when the low
battery displays, or the monitor may be turned off automatically.
2 If you spill liquid onto the equipment or accessories, particularly if there is a chance
that it can get inside the tubing or the measurement device, contact your service
personnel.
3 BP measurement value should be explained by qualified professionals.
4 The pulse rate based on the ambulatory BP measurement may differ from the heart
rate based on the ECG waveform. Ambulatory BP measures the number of peripheral
pulse pulsations, and the heart rate is measured by the electrical signal of the heart.
When the electrical signals of the heart occasionally fail to cause the peripheral blood
vessels to pulse or the patient's peripheral perfusion is poor, the difference happens.
5 Pay attention to the surrounding environment when entering passwords.
1.2.2 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 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,