Specifications
SD32+
System
8. Specifications
8.1. system specifications
Description
Active, non-invasive, medical device.
Intended Use
Amplifier Module for the acquisition (capture,
conditioning, A/D conversion and transferring to a host
system) of bioelectric signals produced by the human
body
Classification According to
MDD 93/42/EEC
Class II b
Safety Standard
93/42/EEC
European Medical Device Directive
(MDD)
IEC 60601-1
General safety standard for
electromedical equipment
IEC 60601-1-1
Collateral safety standard for
electromedical systems
IEC 60601-1-2
Collateral safety standard for device
EMC test
IEC 60601-1-4
Safety standard for devices containing
programmable systems
IEC 60601-2-26
Standard on particular safety
requirements for
electroencephalographs
Type of Protection Against Electric
Shocks
Class I equipment powered by specified power supply
Protection Level Against Direct and
Indirect Electrical Contacts
BF type (patient input)
Protection Level Against Inflow of
Solids and Liquids
IPX0
30
