ORTHORALIX 9200
Service Manual
A-14
Gendex Dental Systems 4519-190-71193-7
A.7
Labels
(04.0)E
LASER RADIATION
DO NOT STARE INTO BEAM
C A U T I O N
Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
Wavelength: 650nm, output Power ≤1mW
CLASS II LASER PRODUCT
A
B
C
D
I
H
G
E
F
CERTIFICATION
Product complies with radiation
performance standards under the
Federal Food, Drug, and Cosmetic Act.
Dental Systems
Des Plaines, IL USA
SN:
0086
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRICAL SHOCK
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH IEC 60601-1
Product complies with
radiation performance
standards under the
Federal Food, Drug, and
Cosmetic Act, and meets
requirements of IEC 60601-1.
CERTIFICATION
0086
CLASS 1
TYPE B
16VL
Gendex Dental Systems, Des Plaines, IL USA
Manufacturer and responsible (93/42/EEC)
Dental Systems - Des Plaines, IL USA
INPUT VOLTAGE
REQUIREMENTS
50 - 60Hz
LONG TERM RATING
MAX. MOMENTARY RATING
115V - 250V
1A - 0.5A
15A - 10A
Type: ORTHORALIX 9200
REF:
SN:
Dental Systems
Des Plaines, IL USA
REF:
SN:
Manufacturer and responsible (93/42/EEC)
DMU UNIT
ATTENTION RAYONS - X
OPERATION SEULEMENT PAR DU
PERSONNEL AUTORISE. VOIR MANUEL DE
L’OPERATEUR.
CAUTION X-RAYS
TO BE OPERATED ONLY BY AUTHORIZED
PERSONNEL. SEE OPERATOR’S
INSTRUCTIONS.
WARNING
THIS X-RAY UNIT MAY BE
DANGEROUS TO PATIENT AND OPERATOR
UNLESS SAFE EXPOSURE FACTORS AND
OPERATING INSTRUCTIONS ARE OBSERVED.
CERTIFICATION
performance standards under
the Federal Food, Drug,
and Cosmetic Act.
Product complies with radiation
Dental Systems
Des Plaines, IL USA
REF:
SN:
DUPLICATE LABEL
FOR FDA/CDRH.
ORIGINAL LABEL
BEHIND THIS COVER
CERTIFICATION
performance standards under the
Federal Food, Drug, and Cosmetic Act.
Product complies with radiation
Dental Systems
Des Plaines, IL USA
REF:
SN:
D
G
A
B
I
A
C
I
H
E
F
ORTHORALIX 9200 DDE
Printed on: 20 Apr 2012, 04:59:40 pm; Printed by: UWE.ZELLER
