Intended Use; Indications / Contraindications; Warnings, Precautions & Safety Considerations - ILLUMINOSS SY-2000 Instructions D'utilisation

The proper set up and operation of this photodynamic curing system will maximize
safety and performance. Please read and follow all safety and operating instructions
compiled in this and other instructions prior to setting up and operating the
photodynamic light source or its individual components. Set-up and activate the
Photodynamic Curing System prior to the start of any surgical procedure using the
IlluminOss implant to ensure proper equipment operation as described in this manual.
Do not use the system or implant if any of its components are damaged or not operating
properly and contact IlluminOss Medical for service or replacement.

1. Intended Use

The intended use of the Photodynamic Light Curing System is to deliver visible light to the
IlluminOss Photodynamic Bone Stabilization System implant to polymerize and harden the
photodynamic liquid monomer contained within the balloon portion of the implant.

2. Indications / Contraindications

Please refer to the implant instructions for use for indications, contraindications and additional
surgical steps.
3. Warnings, Precautions, and Safety Considerations
The words WARNING, CAUTION, and NOTE carry special meanings and should be carefully Reviewed.
Warning: The personal safety of the patient and health professional may be involved. Disregard-
ing this information could result in injury to the patient.
Caution: Special service procedures or precautions must be followed to avoid damaging the
instrument.
Note: Special information to make maintenance easier or important information clearer.
900093.S PHOTODYNAMIC LIGHT CURING SYSTEM INSTRUCTIONS FOR USE - ILLUMINOSS MEDICAL INC
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