Vista Apex pinkwave Mode D'emploi page 12

SAFETY NOTES,
WARNINGS AND PRECAUTIONS
Read all instructions before operating this unit. The PinkWave™ LED Curing Light emits high
intensity light waves and must only be used as indicated in this manual.
Safety Notes
The PinkWave™ Curing Light is a medical device which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives IEC 60601-1-2 (EN 60601-1-2) Edition 4.0, as well as the 93/42/EEC
Medical Device Directive. 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 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.
WARNING
• The user should test the product before use to ensure proper functionality.
• The user should test the PinkWave™'s optical power using a radiometer prior to use.
• An irradiance value 800-1750 mW/cm
and a value 1350-3300 mW/cm
• The irradiance value should be measured at 10s within a 20s cycle for standard
and ramp modes.
• As with any heavily used medical device, the user needs to ensure a functional
backup is readily available.
• DO NOT look directly into the light output. The Autoclavable Light Shield should
always be used. Only Vista Apex provided Protective Eyewear or PinkWave™ Paddle
should be used.
• DO NOT expose soft oral tissues at close proximity. Maintain a safe distance
between the lens and the soft tissue.
• If using the PinkWave™ Curing Light in the Standard Mode and in close proximity
of the gingival tissue, DO NOT expose tissue for more than 20 seconds.
• In Boost Power Mode, DO NOT expose soft oral tissue for more than
9 seconds (3 cycles).
• DO NOT autoclave the handpiece, battery pack or charging base.
• U.S. Federal law restricts the sale of this device by or on the order of a healthcare
professional. Use of the device is restricted to qualified and trained personnel only
in accordance with the instructions below. The manufacturer assumes no liability
for any damage arising from any other or improper use of this device.
12
is acceptable for standard and ramp modes,
2
is acceptable for boost mode.
2