Intended Purpose; Indications; Contraindications - ILLUMINOSS SY- 2000 Instrucciones De Uso

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 Purpose

The intended purpose 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

There are no specific indications for this device.
This device is used only in conjunction with the IlluminOss Photodynamic Bone Stabilization
System, and therefore the indications that govern its use are those of the implant (reference
IFU 900535). The IlluminOss Photodynamic Bone Stabilization System is indicated for use in
fracture alignment and reduction. It provides stabilization for bone fractures using a minimally
invasive technique in which the bone is not subjected to significant weight bearing forces. It
is intended for use in treatment of the metacarpal, phalange, clavicle, radius, ulna, distal
radius, olecranon and fibula. It is also indicated for the treatment of impending and actual
pathological fractures of the humerus from metastatic bone disease.

3. Contraindications

There are no specific contraindications for this device.
This device is used only in conjunction with the IlluminOss Photodynamic Bone Stabilization
System, and therefore the contraindications that govern its use are those of the implant
(reference IFU 900535). The IlluminOss Photodynamic Bone Stabilization System is
contraindicated for:
For all bones:
Patients who are considered skeletally immature.
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Presence of active or incompletely treated infections that could involve the site where
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the device will be implanted.
Patients allergic to any of the implant materials, or to dental glue.
•
Patients whose intramedullary canal at site of fracture measures smaller than the
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diameter of the sheath provided.
Uncooperative patient or patient with neurologic disorder, incapable of following
•
directions.
Distant foci of infections which may spread to the implant site.
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900093.W issued 01-JUL-21 PHOTODYNAMIC LIGHT CURING SYSTEM INSTRUCTIONS FOR USE
PAGE 3 OF 121
- ILLUMINOSS MEDICAL INC