SPECIFICATIONS CV-160
1-10
Item Specification
8. Panel
3. Storage (1) Storage items
Color tone set value
Image enhancement level
Iris mode,
White balance data.
9. For cleaning
1. Panel To remove dust, dirt, and non-patient debris, wipe the unit
using a soft, lint-free cloth moistened with 70% ethyl or
isopropyl alcohol. If the unit is soiled with blood or other
potentially infectious materials, first wipe off all gross debris
using neutral detergent and then decontaminate its surface
using lint-free cloth moistened with 70% ethyl or isopropyl
alcohol.
Country/area
Laws and
regulations applied
Standards to be
conformed to
1. EU/FETA MDD Class: Class I
EN 60601-1
EN 60601-1-1
EN 60601-1-2
EN 60601-1-2-18
IEC 513
IEC 529
ISO 9000-3
ISO 3740
ISO 8600-1
ISO 8600-1.3
Medical Equipment
Safety Laws (510K)
Class: Class II 2. USA
UL/C-UL UL544
CSA22.2 No. 125
3. Japan/
Korea
The Drugs,
Cosmetics and
Medical
Instruments Act
General name:
Light source,
processor
Approval No.
07BZ0043
JIST1001 (medical
electronics safety)
JIST1002 (medical
electronics safety test)
Classification of medical
instruments
10. Safety
1. Laws and regulations
applied
OAI/Asia Protection type against an
electrical shock: Class I
Protection level against
an electrical shock: BF
type
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