Gendex Orthoralix 8500 DDE User Manual

2-3032-0253-EN Rev 3
System Description
Labels - Location and Descriptions
ATTENTION RAYONS - X
CAUTION X-RAYS
OPERATION SEULEMEMENT PAR
DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR.
TO BE OPERATED ONLY BY
AUTHORIZED PERSONNEL. SEE
OPERATOR’S INSTRUCTIONS.
- THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE
EXPOSURE FACTORS AND
OPERATING INSTRUCTIONS ARE
OBSERVED.
WARNING
LASER RADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
Wavelengt h: 650nm, ou tput Power ≤1mW
CLASS II LASER PRODUCT
LASER RADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
Wavelengt h: 650nm, ou tput Power ≤1mW
CLASS II LASER PRODUCT
Des Plaines, IL USA
Gendex Dental Systems
Label No. 408-0343
0.4 IEC 60336 2.5 Al/85 IEC 60522
GENDEX GX 85-15
REF
SN
SN
Certication: Product complies with radiation performance
standards under the Federal Food, Drug, and Cosmetic act.
Certication - Complies with FDA radiation
performance standards 21 CFR, sub chapter J.
Gendex Dental Systems
Panoramic X-Ray Beam Limiter
112-1143G1
SN
REF
11-1234567DP
Des Plaines, IL USA
09 - 2009
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.
Des Plaines, IL USA
Gendex Dental Systems
L
a
b
e
l
N
o
.
4
0
8
-
0
3
4
9
120V 50/60 Hz 1620VA
2.0A ; 13.5A
230V 50/60 Hz 1955VA
1.1A ; 8.5A
REF
Medical Equipment
CLASSIFIED UL60601-1, IEC60601-1
& CAN/CSA-C22.2 No. 601.1-M90
IEC60825-1:2001
34SL
CLASS 1
TYPE B
Certication: Product complies with
FDA performance standards for
radiation and laser products except
for deviations pursuant to Laser
Notice No. 50, dated 24 June 2007
E-Stop
Not on all models

Gendex Orthoralix 8500 DDE Specifications

General

Brand	Gendex
Model	Orthoralix 8500 DDE
Category	Dental equipment
Language	English