Ivoclar Vivadent Bluephase PowerCure Instrucciones De Uso página 18

6 Safety Information
– In the case of serious adverse events in connection with the product, please contact Ivoclar Vivadent AG,
Bendererstrasse 2, 9494 Schaan, www.ivoclar.com, and your local health authorities.
– The current Instructions for Use are available in the download section of the Ivoclar Vivadent AG website
(www.ivoclar.com).
– Bluephase PowerCure is an electrical appliance and a medical device which is subject to IEC 60601-1 (EN 60601-1)
and EMC Standard IEC 60601-1-2 (EN 60601-1-2) as well as the Medical Device Regulation (EU) 2017/745 (MDR).
The curing light complies with the relevant EU regulations.
– 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 must be observed. To prevent damage to equipment and risks for patients, users and third
parties, the following safety instructions must be observed.
Safety notes for the "3sCure program" (3,000 mW/cm
– Avoid direct exposure of the gingiva, oral mucous membrane or skin.
Usage and liability
– Bluephase PowerCure must only be employed for its intended use. Any other uses are contraindicated. Do not
touch defective, open devices. Liability cannot be accepted for damage resulting from misuse or failure to
observe the Instructions for Use.
– The user is responsible for testing Bluephase PowerCure for its use and suitability for the intended purposes.
This is particularly important if other equipment is used in the immediate vicinity of the curing light at the same
time.
– Use only original spare parts and accessories from Ivoclar. The manufacturer does not accept any liability for
damage resulting from the use of other spare parts or accessories.
– The light guide is an applied part and may warm up to a maximum of 45 °C (113 °F) at the interface to the
handpiece during operation.
– Keep out of the reach of children!
– For use in dentistry only!
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.
Do not touch the exposed contacts of the connection plug (power pack). If the battery or power pack are used
separately (i.e. during start-up), contact with patients or third parties must be prevented.
Assumption of impaired safety
If it has to be assumed that safe operation is no longer possible, the power must be disconnected and the battery
removed to avoid accidental operation. This may be the case, for example, if the device is visibly damaged or no
longer works correctly. A complete disconnection from the power supply is only ensured when the power cord is
disconnected from the power source. Ensure that the device can be quickly and easily disconnected at any time.
Eye protection
Direct or indirect exposure of the eyes must be prevented. Prolonged exposure to the light is unpleasant for the eyes
and may result in injury. To optimize user safety, the device has been equipped with intelligent anti-glare protection.
For this, the "polyvision" function must be activated (see 3.2. Operation). With the polyvision function activated, the
Bluephase PowerCure automatically senses if the handpiece is outside of the mouth and automatically switches off
the light if it has been activated inadvertently. If a protective sleeve is used, this function is not available.
In addition, we also recommend using the anti-glare protective equipment supplied. Individuals who are sensitive to
light, who take photosensitizing drugs, have undergone eye surgery, or work with the apparatus (or in its vicinity) for
long periods of time, should not be exposed and should wear protective orange goggles that absorb light below a
wavelength of 515 nm. The same applies for patients.
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