Product Compliance - Critikon DlNAMAP PRO Series 100-400 Operation Manual

.l . ALSO EVALUATED TO IEC-601-2-30.
CC
0086
This product conforms with the essential requirements
of the Medical Device Directive. Accessories without
the CE mark are not guaranteed to meet the Essential
Requirements of the Medical Device Directive.
10
DINAMAP@ PRO MONITOR
CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE
AND MECHANICAL AND OTHER SPECIFIED HAZARDS
ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.
601
C
us
QD
@
IPXl, degree of protection against ingress of water
l
Sterilization/Disinfection, see Appendix F
I, internally powered
l
Transportable
l
For continuous operation
l
Not suitable for use in the presence of flammable
anesthetics
l
Not for use in the presence of an oxygen-enriched
atmosphere (oxygen tent)
l
Type BF applied parts
l
IEC 601-l :
l
Class
DINAMAP@
PRO Monitor is classified in the following
categories for compliance with
Product Compliance
The