ViewLight UNICOS UDR-800P - Safety Information; EU Representative Information

2
O
O
p
p
e
e
r
r
a
a
t
t
i
i
o
o
n
n
M
M
a
a
n
n
u
u
a
a
l
l
SAFETY INFORMATION
Accessory equipment connected to the analog and digital interfaces must be certificated
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipments).
Furthermore all configurations shall comply with the system standard IEC 60601-1-
2:2014+AMD1:2020.
Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 60601-1:2010+AMD2:2020.
If in doubt, consult the technical service department or your local representative.
For EU Countries
 The following mark, the name & address of the EU Representative shows compliance of the
instrument with Directive Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 concerning medical devices.
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain.