Preva Installation/Service Manual, 00-02-1577, Revision E01
14
3
International Electrotechnical Commission
4
National Electrical Code
5
Verband Deutscher Elektrotechniker (Association of German Electrical Engineers)
Safety
• Allow only qualified and authorized personnel, observing all laws and
regulations concerning radiation protection, to operate this equipment.
• The operator must remain at all times a safe distance from the focal spot and
the X-ray beam.
• Utilize all of the equipment's radiation safety features.
• To protect both the patient and the operator from X-ray radiation, employ all
available radiation protection devices, accessories, and procedures.
Safety
To avoid electric shock, connect this equipment only to supply
mains with protective earth.
• Because the design of the Preva power supply circuit may momentarily draw
high current,
• Do not use this device with wall outlets having GFCIs (Ground Fault Circuit
Interrupters). Outlets with GFCI are designed to trip when they sense a small
amount of current passing from the line to earth ground. Outlets with GFCI
can compromise the operation of the intra-oral X-ray device and the GFCI
circuit itself.
• Allow only qualified and authorized service personnel to remove equipment
covers.
• All maintenance requiring the removal of protective covers must be executed
by service personnel only when patients are not present.
• Replace sensors only when a patient is not in contact with the machine or the
operator.
Do not touch the USB connector on the articulated arm.
• This equipment must be used only in rooms or areas complying with all
applicable laws and recommendations concerning electrical safety in rooms
used for medical purposes, e.g., IEC
3
, NEC
4
, or VDE
5
standards concerning
provisions of an additional protective earth (ground) terminal for power supply
connection.
• Before cleaning or disinfecting, this equipment must be disconnected from the
main electrical supply.
• The Preva Dental X-ray System is ordinary type medical equipment without
protection against ingress of liquids. To protect against short-circuit and
corrosion, no water or any other liquid should be allowed to leak inside the
Safety
Device
Disposal
This equipment must not be used in the presence of flammable or potentially
explosive gases or vapors, which could ignite, causing personal injury and/or
damage to the equipment. If such disinfectants are used, the vapor must be
allowed to disperse before using the equipment.
To ensure compliant and safe disposal of waste electrical and electronic equipment,
contact the Midmark dealer or local regulatory or public health authorities.
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