Intended Use; Operating Instructions; Safety Notes - Ivoclar Vivadent LEDition Mode D'emploi

Safety

Intended use

The LED polymerization light produces energy-rich blue
light. It is intended for the polymerization of light-curing
dental materials directly at the dental unit. These
Operating Instructions provide recommendations and
guidelines for the intended use of the light. Please read
them carefully.
Indication
The LED polymerization light is particularly suitable for
the polymerization of light-curing dental materials activa-
ted in the wavelength range of 430–490 nm.
Contraindication
Materials, the polymerization of which is
activated outside the wavelength range of
430–490 nm. If you are not sure about certain
products, please ask the manufacturer of the
corresponding material.
This unit should not be used near a flammable
anaesthetic mixture with air, oxygen or nitrous
oxide.
Portable and mobile HF communication devices
may interfere with medical equipment. The use
of mobile phones during operation is not
allowed.
Patients with heart or brain pacemakers can be
treated with LEDition. Investigations have
shown that there are no (electromagnetic)
incompatibilities between the curing light and
pacemakers.
Signs and symbols
Instructions for Use
Contraindication
Symbols on the curing light
Double insulation (Apparatus complies with
safety class II)
Protection against electrical shock
(BF type apparatus)
Use only in protected areas
2
Observe Operating Instructions
Do not dispose of the apparatus with normal
domestic waste Please visit your local Ivoclar
Vivadent website for detailed information
about the disposal of the unit.

Safety notes

the manufacturer in a safe and technically sound conditi-
on. In order to maintain it in this condition and to ensure
riskfree operation, the notes and guidelines in these
Operating Instructions have to be observed. To prevent
damage to equipment and protect patients, users and
third parties from risks, the following safety instructions
have to be observed:
1. Usage and liability
The LED polymerization light must be employed solely
for the intended use. Any other uses are contra-
indicated. Liability cannot be accepted for damage
resulting from misuse or failure to observe the
Operating Instructions. Furthermore, the user is
responsible for testing the LED polymerization light for
its use and suitability for the intended purposes. This is
particularly important if other equipment is utilized in
the immediate vicinity of the apparatus at the same
time as the curing light is being used. Use only original
components. The manufacturer does not accept any
liability for damage resulting from the use of other
components.
NRTL
(Nationally Recognized
Testing Laboratory)
The apparatus has been
designed according to
IEC60601-1, EN60601-1
and UL60601-1; CSA
C22.2 No. 601.1 (2003),
complies with the relevant
EU regulations, and has
been certified by TÜV
Product Service as an
internationally accredited
testing body. The appara-
tus has been shipped from