Intended Use; Indications; Safety Notes; Contraindications - Ivoclar Vivadent Bluephase 20i Mode D'emploi

Safety

Intended use

Bluephase 20i is an LED polymerization light that produces
energy-rich blue light. It is used for the polymerization of
light-curing dental materials immediately at the dental unit.
The intended use also includes the observation of the notes
and regulations in these Instructions for Use.
Indication
With its "Polywave " broadband spectrum, Bluephase is
®
suitable for the polymerization of all light-curing dental
materials curing in the wavelength range of 385–515 nm.
These materials include restoratives, bonding agents/
adhe-sives, bases, liners, fissure sealants, temporary
materials as well as luting materials for brackets and
dental-lab materials such as those used in the fabrication of
ceramic inlays.

Safety notes

Bluephase 20i is an electronic device and a medical product
which is subject to IEC 60601-1 (EN 60601-1) and EMC
directives, as well as the 93/42/EEC Medical Device
Directive. The appliance complies with the relevant EU
regulations and is classified as an LED Class 2 product.
NRTL (Nationally Recognized
Testing Laboratory)
The curing light has been shipped from the manufacturer in
a safe and technically sound condition. In order to maintain
this condition and to ensure risk-free operation, the notes
and regulations in these Instructions for Use have to be
observed. To prevent damage to equipment and risks for
patients, users and third parties, the following safety
instructions have to be observed.
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Contraindications

Materials, the polymerization of which is activated
outside the wavelength range of 385–515 nm
(no materials known to date). If you are not
sure about certain products, please ask the
manufacturer of the corresponding material.
Do not charge or use the appliance near
flammable or combustible substances.
Portable and mobile high-frequency com-
munication devices may interfere with medical
equipment. The use of mobile phones during
operation is not allowed.
Caution – The use of controls or adjustment
devices or the performance of procedures other
than those specified herein may result in haz-
ardous radiation exposure.
Usage and liability
– Bluephase 20i must only be employed for the intended
use. Any other uses are contraindicated. Liability cannot
be accepted for damage resulting from misuse or failure
to observe the Operating Instructions.
– The user is responsible for testing Bluephase 20i for its
use and suitability for the intended purposes. This is par-
ticularly important if other equipment is used in the
immediate vicinity of Bluephase at the same time.
– Only original spare parts and accessories from Ivoclar
Vivadent (see Accessories) should be used. The manu-
facturer does not accept any liability for damage resulting
from the use of other spare parts or accessories.
– The light probe is an applied part and may warm up to a
maximum of 45 °C (113 °F) at the interface to the hand-
piece during operation.
Operating voltage
Before switching on, make sure that
a) the voltage indicated on the rating plate complies with
the local power supply and
b) the unit has acquired the ambient temperature.
If the battery or power pack are used separately, e.g.
during start-up or Click & Cure corded operation, contact
with patients or third parties must be prevented. Do not
touch the exposed contacts of the battery or connection
plug (power pack).