IVY LS810-B Guía De Usuario página 19

Weight Approx.110g
External dimensions Approx.79.8mm×72.5mm×13.2mm
Attachment USB cable, user manual
Mode of operation Continuous operation
Degree of
Type BF applied part
protection
Protection against IP22, It means the device could protect against solid strange objects of 12.5 mm and
ingress of water greater, and against vertically falling water drops when ENCLOSURE tilted up to 15°
Software version V01
Battery Powered Mode:
Device classification Internally Powered ME Equipment
AC Adaptor charged Mode: Class II ME Equipment
Standards:
Title
Medical Device Quality System for the regulation requirement
Medical device risk management to medical devices application
Symbol for the label of medical devices
Term, symbol and information of medical device— information of medical device
manufacturer offering
Medical electrical equipment – Part 1: General requirements for safety
Medical electrical equipment – Part 1-2: General requirements for safety –
Collateral standard: Electromagnetic compatibility – Requirements and tests
Clinical investigation of medical devices for human subjects. General require-
ments
Clinical investigation of medical devices for human subjects. Clinical investigation
plans
Medical device software – Software life-cycle processes
Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability
Medical electrical equipment. Part 1-11:General requirements for basic safety
and essential performance. Collateral standard:Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment.
WIRELESS WRIST BLOOD PRESSURE MONITOR
EN
IVBPW
Code
EN ISO 13485:2012
EN ISO14971:2012
EN 980:2008
EN 1041:2008
EN 60601-1: 2005/AC:2012
EN 60601-1-2:2007
EN ISO 14155-1:2009
EN ISO 14155-2:2009
EN 62304:2006/AC: 2008
EN 60601-1-6:2010
EN 60601-1-11:2010
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