Location Of Identification Labels - Gendex ORTHORALIX 8500DDE Installation Manual

Orthoralix 8500 DDE Installation Manual

Location of Identification Labels

E-Stop
Not on all models
0.4 IEC 60336
GENDEX GX 85-15
REF
Certification: Product complies with radiation performance
standards under the Federal Food, Drug, and Cosmetic act.
2-6
Gendex Dental Systems
Des Plaines, IL USA
2.5 Al/85 IEC 60522
SN
SN
Panoramic X-Ray Beam Limiter
Gendex Dental Systems
REF 112-1143G1
C er t ifica ti on - C omp lie s w ith FD A r a dia tio n
p er fo rma nce s tan dar ds 2 1 C FR, su b ch a pt er J .
SN 09 - 2009
11-1234567DP Des Plaines, IL USA
C A U T I O N
LASER RADIATION
DO NOT STARE INTO BEAM
Wavelength: 650nm, output Power ≤1mW
Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
CLASS II LASER PRODUCT
Gendex Dental Systems
Des Plaines, IL USA
120V 50/60 Hz 1620VA
2.0A ; 13.5A
34SL
230V 50/60 Hz 1955VA
1.1A ; 8.5A CLASS 1
TYPE B
Cer tific ation: Produc t complies with
FD A perfor mance s tandar ds for
radiation and laser produc ts exc ept
CLASSIFIED UL60601-1, IEC60601-1
for dev iations purs uant to Laser
& CAN/CSA-C22.2 No. 601.1-M90
Notice No. 50, dated 24 June 2007
REF
ATTENTION RAYONS - X
OPERATION SEULEMEMENT 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.
ATTENTION RAYONS - X
OPERATION SEULEMEMENT 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,
OPERATING INSTRUCTIONS AND
MAINTENANCE SCHEDULES ARE
OBSERVED.
C A U T I O N
LASER RADIATION
DO NOT STARE INTO BEAM
Wavelength: 650nm, output Power ≤1mW
Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
CLASS II LASER PRODUCT
Medical Equipment
IEC60825-1:2001
032-0246-EN Rev 2