Trouble-Free Operation; Interference With Electronic Devices; Risks Of Electromagnetic Fields; Combination With Other Equipment - Dentsply Sirona Orthophos E Ceph Operating Instructions Manual

Dentsply Sirona
Operating Instructions Orthophos E
67 11 001 D3352
D3352.201.12.01.02 03.2019

Trouble-free operation

2.11
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.
2.12

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.
2.13

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.

Combination with other equipment

2.14
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.
2 Safety instructions
2.11 Trouble-free operation
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