INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F
Pag. 10 of 51
CAUTION
CAUTION
The radiographic system contains high voltage. It’s prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the radiographic system must only be removed by qualified and authorized service personnel.
The unit must be used only in environments that are in compliance with all electrical safety standards set forth for
medical environments.
To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth.
The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure
that no water or other liquids penetrate inside in order to avoid short circuits or corrosion.
Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning to clean,
disinfect and maintenance operations.
Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to any type of extension cord.
External equipment intended for connection to signal input, signal output or other connectors shall comply with the
relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment.
In addition, all such combinations shall comply with the safety requirements stated in the general standard CEI EN
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in CEI EN 60601-1
shall be kept outside the patient environment i.e. at least 1,5 m from the patient support.
It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular, such a Separation Device is
required when a network or data connection is made. The requirements on the Separation Device is defined in CEI EN
60601-1, edition 3, clause 16.
For the wall version of radiographic system:
based on the CEI EN 60601-1, the installation is a permanent type (fixed). IT IS NOT ALLOWED TO connect the
equipment to the main supply using a plug.
The cone (beam limiting device) is an APPLIED PART of the system and it is classified as type B.
EMC COMPATIBILITY
EMC requirements must be considered and the “x-mind dc” must be installed and used accordingly with the specific
EMC information provided in the accompanying documents.
The device complies with the EMC (Electromagnetic Compatibility) requirements, according to CEI EN 60601-1-2. Radio
transmitting equipment, cellular phones etc. shall not be used in close proximity of the unit as they could influence the
performance of the system.
Carefully read the indications relevant to the EMC in the dedicated appendix EMC compatibility of user manual.
Repairs and replacements of any component included cables, must be carried out only using genuine spare parts
supplied by de Götzen S.r.l. Using other cables may negatively affect EMC performance.
To Next Page
Loading...
