4
INSTALLATION
compact piezo LeD, in order to operate must
be connected to a dental unit.
the dental unit mechanically houses the pilot
module, supplies power to the module, and
supplies water to cool the handpieces and
inserts.
the dental unit to which compact piezo LeD
is connected must be a medical device that
complies with general and applicable product
regulations for the specific category of dental
unit, and in general, satisfy the following
4.1
Safety precautions During Installation
CAUTION: the voltage of the electric
power supply to which the device will be
connected must be compatible with the
device technical specifications (see
6 on page 24
) and the chosen connection
diagram.
CAUTION: Use a power supply
conforming to IEC / EN 60601-1 with the
following characteristics:
• 24 V~ 50/60 Hz or
• 32 V
with a minimum power of 40Va.
CAUTION: DO NOT invert, for any
reason, the position of the red and black
wires on the connector of the scaler
Figure 4 at page 18
handpiece (
CAUTION: Do not wire the red and black
wires of the scaler handpiece cord (see
4 at page 18
) together with other wires.
CAUTION: if long connections are
needed for the power supply, use wires of
adequate section, for example 1.5 mm
CAUTION: the water hose of the scaler
handpiece cord must be directly connected
to the dental unit cold water circuit.
WARNING: install the device in a safe
place protected from impact or accidental
water or liquid spray.
standards:
• ISO 7494 Dentistry – Stationary dental
• ISO 60601-1 Medical electrical
NOTE: check that the dental unit to which
compact piezo LED is connected satisfies the
specified requirements.
WARNING: Do not install the device
above or near sources of heat. arrange
during installation for a suitable circulation of
chapter
air around the device.
CAUTION: the electrical system of the
premises in which the device is installed
and used must be compliant to the norms
in force and to the relative electrical safety
precautions.
WARNING: the technician or the
manufacturer of the dental chair on which
the compact piezo LeD has been installed
is responsible for the compliance of the
product and of the entire system to the IEC/
EN 60601-1 in law.
).
WARNING: Contraindications.
Interference with other equipment.
Figure
Though compliant to the standard IEC 60601-
1-2, compact piezo LeD may nonetheless
interfere with other devices nearby.
compact piezo LeD must not be used near
to or stacked on other devices. However,
.
2
if this were to prove necessary, check and
monitor correct operation of the device in
that configuration.
WARNING: Contraindications.
Interference from other equipment.
an electrical scalpel or other electro-surgical
units near the compact piezo LeD device may
interfere with its correct operation.
iNStaLLatioN
units and dental patient chairs;
equipment – Part 1: General
requirements for basic safety and
essential performance.
11
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