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systems used in home healthcare environment
IEC 80601-2-30
Medical Electrical Equipment - Part 2-30: Particular requirements
for basic safety and essential performance of automated non-
invasive sphygmomanometers
ISO 81060-2
Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of
Automated Measurement Type
EN 62304
Medical device software - Software life-cycle processes
EN 62366
Medical devices – Application of usability engineering to medical
devices
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
12 . Disposal
Dispose of the device in accordance with the regulations applicable at the place of operation.
Dispose of at public collection point in the EU countries – 2002/96/EC WEEE Directive.
If you have any queries, please refer to the local authorities responsible for waste disposal.
NOTES:
●
Handing of battery and wastes method, please act according to the native law to proceed to handle.
To protect the environment, dispose of empty battery at your retail store or at appropriate
collection sites according to national or local regulations.
13 . NORMALIZED SYMBOLS
Symbol
Explanation
Please do not disassemble or repair or modify the Blood pressure Monitor and its
accessories
Manufacturer
Follow operating instructions
IP22
The first number 2: Protected against solid foreign objects of 12.5 mm Ф and
greater. The second number2: Protected against vertically falling water drops
when enclosure titled up to 15
°
.
BF type applied part
Disposal in accordance with Directive 2002/96/EC (WEEE)
1639
Complies with the European Medical Device Regulation ( 2017/745. Notified
Body is SGS.
