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ENGLISH 27
QUALITY CONTROL
The BPM-V20-B (B22) complies with ISO 80601-2-30 Medical Electrical Equipment
(Special Requirements for the basic safety and performance of automatic non-invasive
blood pressure monitors) and the European standards for non-invasive blood pressure
monitors: EN 1060-1 · EN 1061-3 · EN 1060-4.
The manufacturer has the ISO 13485 certificate (Quality Assurance System – Medical
devices). In addition, the device must meet the requirements of the following
certificates:
·ISO 14971 (2012) Medical devices – Application of risk management for medical devices
·IEC 60601-1 (2012) Medical Electrical Equipment – Part 1: General Safety Requirements.
·IEC 60601-1-2 (2007) Medical electrical equipment – Part 1-2: General requirements for
the safety-additional requirements for the electromagnetic compatibility and testing.
·ISO 14155 (2011) Clinical testing of medical devices for humans – good clinical practice.
The manufacturer and the importer guarantee that the purchased device will free
from defects in material and workmanship for a period of two years from the date of
sale if used under normal conditions and maintenance. The guarantee does not cover
damage caused by improper handling, accidents, proper use, failure to observe the
operating instructions or changes to the device caused by third parties. The two year
guarantee only applies to the device. For all accessories, including the cuff, expect the
USB-charging cable the guarantee is one year. There are no user serviceable parts inside.
Batteries or damage that caused by the use or exhaustion of old batteries are also not
covered by the guarantee. If service is required within or after the warranty period,
contact your dealer. Manufacturers and distributors are not liable for damage caused by
improper use.
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