SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance
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32. Assembly of the ABPM and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
33. This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions:
1) This device may not cause harmful interference, and
2) this device must accept any interference received, including interference that may
cause undesired operation.
CAUTION
1. Do not use the monitor if it displays a greater than zero pressure with no cuff attached.
The values displayed by such a monitor may be inaccurate.
2. Ambulatory blood pressure measurement can be affected by extremes of temperature,
humidity and altitude.
NOTE:
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.
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