english
english
EN-56
EN-57
Technical information
Technical information
E
E
Minimum expected
service life:
2 years
Software:
Version A01
7. Explanation of symbols
This product complies with the Council Directive 93/42/EC from
5 September 2007 regarding medical devices and bears the
mark CE 0123 (TÜV SÜD Product Service GmbH).
Degree of protection against electric shock: TYPE BF
Please observe instructions for use
Please observe instructions for use
Manufacturer
Green Dot
Reference number = item number
Serial number
Alternating current
Direct current
Equipment class II (double-insulated)
For indoor use only
8. Disposal
Batteries and technical appliances must not be disposed of
with domestic waste, but should be handed in at the appropri-
ate collection and disposal points.
Please consult visomat customer service if you have questions on dispos-
ing the integrated lithium-ion batteries (see page 54).
9. Applied standards
Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
Labeling
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices
- Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
User manual
EN 1041:2008 Information supplied by the manufacturer of
medical devices
General Require-
ments for Safety
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 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
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromag-
netic disturbances - Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers
- Part 1: Requirements and test methods for non-automated
measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanom-
eters - Part 3: Supplementary requirements for electro-me-
chanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equip-
ment - Part 2-30: Particular requirements for the basic
safety and essential performance of automated non-invasive
sphygmomanometers
Clinical investi-
gation
EN 1060-4:2004 Non-invasive sphygmomanometers - Part
4: Test procedures to determine the overall system accuracy
of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part
2: Clinical validation of automated measurement type
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-1-
6:2010+A1:2013 Medical electrical equipment - Part 1-6:
General requirements for basic safety and essential perfor-
mance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle processes
