Trouble-Free Operation; Interference With Electronic Devices; Risks Of Electromagnetic Fields; Combination With Other Equipment - Sirona galileos comfort plus Operating Instructions Manual

2 Safety information
2.11 Trouble-free operation
14
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
2.11

Trouble-free operation

Use of this system is permissible only if it works properly without
Generally valid
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-
Trouble-free operation
free.
The movements of the unit must not be obstructed by physical
Obstruction of unit movements
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
Unit cover
hood.
2.12

Interference with electronic devices

To prevent the malfunctioning of electronic devices and data storage
devices, e.g. radio-controlled watches, telephone cards, etc., these
objects must be removed prior to X-raying.
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
equipment manufacturer.
2.14

Combination with other equipment

Any person, who assembles or modifies a medical electrical system
complying with the standard IEC 60601-1 (safety requirements for
medical electrical equipment) by combining it with other equipment is
responsible for ensuring that the requirements of this regulation are met
to their full extent for the safety of the patients, the operators and the
environment.
If any devices not approved by Sirona are connected, they must comply
with the applicable standards:
● IEC 60950-1 for information technology equipment and
● IEC 60601-1 for medical devices
See "Installation requirements" and the compatibility list/declaration of
conformity by the system integrator.
If in doubt, contact the manufacturer of the system components.
Sirona Dental Systems GmbH
64 91 208 D3437
D3437.201.09.07.02 12.2015