Safety; Intended Use; Indications; Safety Notes - Ivoclar Vivadent bluephase 20i Instrucciones De Uso

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 Operating Instructions.
Indication
With its "polywave" broadband spectrum, bluephase is
suitable for the polymerization of all light-curing dental
materials curing in the wavelength range of 380-515 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 materi-
als such as those used in the fabrication of ceramic inlays.
Contraindications
• Materials, the polymerization of which is activated out-
side the wavelength range of 380-515 nm (no materials
known to date). If you are not sure about certain prod-
ucts, please ask the manufacturer of the corresponding
material.
• This unit should not be used near flammable anaesthetics
or mixtures of flammable anaesthetics with air, oxygen or
nitrous oxide.
• Portable and mobile high-frequency communication
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 hazardous radiation exposure.

Safety notes

The bluephase 20i is a medical electronic device which is
subject to IEC 601-1 (EN 60601-1) and EMC standards (see
appendix). It complies with the relevant EU regulations and
is classified as LED Class 2.
LED LIGHT
DO NOT STARE INTO BEAM
CLASS 2 LED PRODUCT
Max. 5,11 mW / Wavelenght 380 - 515 nm
IEC 60825-1:1993+A1:1997+A2:2001
8
The apparatus 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 Operating Instructions 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.
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 manufac-
turer does not accept any liability for damage resulting
from the use of other spare parts or accessories.
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).
Assumption of impaired safety
If it is assumed that safe operation is no longer possible,
the power must be disconnected and the battery removed