Olympus CLV-160 - 8. Electrical Shock Protection

SPECIFICATIONS CLV-160
Item
Protection system
Specification
Class I units (3P power supply)
Non-Olympus regulations applied
Common to every
country
1 EU/EFTA
IEC513 (hazard analysis)
IEC60601-1 (medical electronics
safety)
IEC60601-l-1 (medical electric
system safety)
IEC60601-1-2 (EMC)
IEC60601-2-18 (endoscope
electric safety)
Applied laws and
regulations/classification
MDD Class: IIa
CE marking: CE
0197
2 USA
3. Japan
FDC laws (Federal
Foods/Medicine/Cosmetics Laws)
The Drugs, Cosmetics and
Medical Instruments Act
General name: Light source
Approval No. : 07BZ0043
JIST1001 (medical electric
equipment safety)
JIST1002 (medical electric
equipment safety test)
JIST1005 (medical electric
equipment manual)
Russia: GOST-R
4 Other countries Nothing
Classification of medical
100 V type: BF type instruments
instruments
200 V type: BF type fitting part
Note) When the fitting part has no indication of protection
against an electric shock, it is the BF type fitting part.
Class I
Xenon lamp, Special filter, Fuse
Protection against an
electrical shock
User service
ISO9000-3 (software)
ISO8600-1 (endoscope)
ISO7000 (drawings and
symbols)
IEC417 (drawings and
symbols)
Non-Olympus regulations
applied
IEC60601-1 (medical
electronics safety)
IEC60601-l-l (medical
electric system safety)
IEC60601-1-2 (EMC)
IEC60601-2-18 (endoscope
electric safety)
EN980 (drawings and
symbols)
UL544,CUL
Maker service
Emergency lamp, Lamp socket
Weight
Approx. 15 kg
Dimensions (Maximum)
385 (w) x 490 (D) x 145 (H)
[mm]
l-3