Guidance And Manufacturers Declaration - ILLUMINOSS SY- 2000 Instrucciones De Uso

Symbol

14. Guidance and Manufacturers Declaration

900093.W issued 01-JUL-21
Description
The atmospheric pressure to which the Photodynamic Light Curing System can be
safely exposed is 700hPA to 1060hPA
Fragile, handle with care
Consult Instructions for Use. Instructions for Use are provided in the original
packaging, and also on the IlluminOss website at
Handling instructions, to preserve device integrity.
The Photodynamic Light Curing System should not be used if the package has been
damaged.
Caution: Federal law restricts this device to sale by or on the order of a physician
Indicates the date when the Photodynamic Light Curing System was manufactured.
Indicates the Medical Device manufacturer of the Photodynamic Light Curing System,
IlluminOss Medical. Any serious incident that has occurred in the relation to the device
should be reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
Indicates the manufacturer's serial number so that a specific Photodynamic Light
Curing System can be identified.
Indicates the authorized representative in the European Community. Any serious
incident that has occurred in the relation to the device should be reported to the
manufacturer. Reporting to the Authorized Representative is one means of doing so.
Indicates the catalog number so that the medical device can be identified
Medical device: This symbol indicates the product is intended by the manufacturer to
be used for human beings for a specific medical purpose.
CERTIFIED TO:
CONFORMS TO:
ROHS COMPLIANT
CALIBRATION OF LIGHT CURING SYSTEM IS NOT REQUIRED.
PHOTODYNAMIC LIGHT CURING SYSTEM INSTRUCTIONS FOR USE
www.illuminoss.com/ifu
CAN / CSA STD C22.2 NO. 601.1-M90:2003
CAN / CSA STD C22.2 NO. 601.1-10-92
EN 60601-1-2/A1:2007
EN 55011/A2:2007
IEC 60601-1:A2:1995 + 2005 (3rd)
IEC 60601- 2-18:2009
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- ILLUMINOSS MEDICAL INC