Modifications To The Unit; Structural Alterations; Electromagnetic Compatibility - Sirona galileos comfort plus Operating Instructions Manual

Sirona Dental Systems GmbH
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
64 91 208 D3437
D3437.201.09.07.02 12.2015
2.15

Modifications to the unit

Modifications to this unit which might affect the safety of the system
owner, patients or other persons are prohibited by law!
For reasons of product safety, this product may be operated only with
original Sirona accessories or third-party accessories expressly approved
by Sirona. The user is responsible for any damage resulting from the use
of non-approved accessories.
2.16

Structural alterations

If structural changes are made in the vicinity of the X-ray unit which result
in the device being exposed to very high levels of vibration or even
impact, the device must be inspected by a service engineer and re-
adjusted and re-calibrated if necessary.
2.17

Electromagnetic compatibility

The GALILEOS Comfort PLUS X-ray unit complies with the requirements
EMC regarding high-voltage, radio link and MRI systems
of the standard IEC 60601-1-2.
Medical electrical equipment is subject to special EMC preventive
measures. It must be installed and operated as specified in the
"Installation Requirements" document.
If high-voltage systems, radio link systems or MRI systems are located
within 5 m of the unit, please observe the specifications stated in the
installation requirements.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
Please also observe the ESD protective measures described in the
section "Electrostatic Discharge".
2 Safety information
2.15 Modifications to the unit
15