MUMU-BP Blood Pressure Monitor Manual V0.5
Page
31
3.6
Statement
1 The unit satisfies the requirements of EN60601-1
：
Medical electrical
equipment Part 1: General requirements for basic safety and essential
performance; EN60601-1-2: Medical electrical equipment Part 1-2:
General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and
tests; EN1060-1: Non-invasive sphygmomanometers – Part 1: General
requirements; EN1060-3: Non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electro-mechanical blood pressure
measuring system. EN1060-4
：
Non-invasive sphygmomanometers – Part 4:
Test procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers.
2 The Unit complies with IEC 80601-2-30.
3The unit had pass EMC test.
4 The risk of patient and user can be lowered to acceptable level.
5 Substitution of a cuff different from that supplied might result in
measurement error.
6 Specifications are subject to change without notice due to improvements
in performance.
7 The unit might not meet its performance specifications if stored or used
outside the following specified temperature and humidity ranges.