Planmeca ProMax 3D Max with ProTouch 5
SAFETY PRECAUTIONS
User’s Manual
NOTE FOR US & CANADIAN USERS:
The patient positioning lights are class II laser
products (21 CFR § 1040.10).
NOTE FOR EUROPEAN USERS:
The patient positioning 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 Never place or hang any objects on any part of the X-
ray unit.
NOTE Make sure that neither you nor your patient can get
caught or hooked up on any part of the X-ray unit.
Keep loose items of clothing, hair and jewellery tucked
away safely.
NOTE If you have any reason to believe that the C-arm might
hit the patient during exposure (e.g. patients with wide
shoulders), take a test exposure without radiation
first. To switch radiation off, select Service spanner >
User > 1300 Operational settings > 1310 User Mode >
1311 Set Demo Mode.
NOTE Do not touch the arm structures when the X-ray unit is
moving.
NOTE Patients are not allowed to hang on the patient
handles.
NOTE FOR PROFACE SENSOR:
Do not touch the glass windows. Fingerprints or other
stains on the glass surface destroy image quality.
CAUTION
LASER RADIATION -
DO NOT STARE
INTO BEAM
1mW
635nm
CLASS II
LASER
PRODUCT
LBL-X-099
CLASS 1 LASER PRODUCT
APPAREIL À LASER DE CLASSE 1
IEC 60825-1:2007
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