ivoclar Bluephase N G4 Instrucciones De Uso página 16

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 Instructions for Use are stored on the website of Ivoclar Vivadent AG (www.ivoclar.com).
– Bluephase N G4 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 riskfree 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.
Usage and liability
– Bluephase N G4 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 N G4 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 Vivadent. 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 set-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. 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.
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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