Planmeca ProMax 3D s User Manual page 11

CLASS 1 LASER PRODUCT
APPAREIL À LASER DE CLASSE 1
IEC 60825-1:2007
User's Manual (3D Imaging)
CAUTION
LASER RADIATION -
DO NOT STARE
INTO BEAM
1mW CLASS II
635nm LASER
PRODUCT
NOTE
FOR US & CANADIAN USERS:
The laser lights are class II laser products (21 CFR §
1040.10).
NOTE
FOR EUROPEAN USERS:
The laser lights are class 1 laser products (Standard IEC /
EN 60825-1: 2007).
NOTE
EMC requirements have to be considered, and the
equipment must be installed and put into service according
to the specific EMC information provided in the
accompanying documents.
NOTE
Portable and mobile RF communications equipment can
affect the X-ray unit.
NOTE
External equipment intended for connection to signal
input, signal output or other connectors, shall comply with
relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical
equipment). In addition, all such combinations - systems -
shall comply with the standard IEC 60601-1-1, Safety
requirements for medical electrical systems. Equipment
not complying to IEC 60601 shall be kept outside the
patient area (more than 2m (79 in.) from the X-ray unit).
Any person who connects external equipment to signal
input, signal output or other connectors has formed a
system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1. If in
doubt, contact your service technician or local
representative for help.
NOTE
Contact your service technician if you notice a decrease in
image quality.
NOTE
Contact your service technician if you have taken an
exposure but the image does not appear in the Planmeca
Romexis program. The last ten images can be manually
imported into Romexis.
NOTE
Do not handle liquids near or on the X-ray unit.
NOTE
Never place or hang any objects on any part of the X-ray
unit.
Planmeca ProMax 3D s & 3D Classic
4 SAFETY PRECAUTIONS
7