64 94 954 D3632
D3632
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201.03.08
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23 07.2018
15
Dentsply Sirona
2 Safety information
Operating Instructions Orthophos SL 2D / 3D
2.12 Trouble-free operation
2.12
Trouble-free operation
Use of this system is permissible only if it works properly without
malfunctions. If trouble-free operation cannot be ensured, the unit must
be taken out of service, checked by authorized technicians for
malfunctions and, if necessary, repaired.
X-rays of patients may be taken only when the system is working trouble-
free.
The movements of the unit must not be obstructed by physical
constitution, clothing, dressings, wheelchairs, or hospital beds.
The travel range of the unit must be kept free from foreign matter.
Do not leave the patient at the unit unattended.
The device may only be operated with a complete cover and protective
hood.
2.13
Interference with electronic devices
To prevent the malfunctioning of electronic devices and data memories,
these objects must be removed prior to the X-ray exposure.
2.14
Risks of electromagnetic fields
The function of implanted systems (cardiac pacemakers or cochlear
implants, for example) can be affected by electromagnetic fields. Before
commencing treatment, ask if the patient has a cardiac pacemaker or any
other implanted system.
Any prevailing risks are listed in the documentation provided by the
implant manufacturer.
2.15
Combination with other equipment
Putting together or altering a medical electrical system by combining with
other devices in accordance with IEC 60601-1 (safety requirements for
medical electrical systems) is subject to the obligation to ensure
compliance with the requirements of this provision for patient safety, the
operator, and the environment.
If any devices not approved by Dentsply Sirona are connected, they must
comply with the applicable standards:
● IEC 60950-1 or IEC 62368-1 for information technology equipment
and
● IEC 60601-1 for medical electrical equipment
To this end, refer to the ‘Installation requirements’ and compatibility list/
declaration of conformity by the system integrator.
If in doubt, contact the manufacturer of the system components.
Summary of Contents for Orthophos SL 2D
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