Warnings, Precautions, And Safety Considerations - ILLUMINOSS SY- 2000 Instrucciones De Uso

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Vascular insufficiency.
•
Open fractures with severe contamination.
•
Extremely comminuted fractures where insufficient holding power of the balloon on
•
the intramedullary canal is probable.
Delivery sheath is unable to cross fracture site after proper fracture reduction and
•
realignment.
For Humerus with acute fractures:
Patients who are under the age of Fifty (50)
•
For all bones excluding pathologic Humerus:
Metabolic disorders which may impair bone formation.
•
Osteomalacia.
•
Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
•

4. Warnings, Precautions, and Safety Considerations

The words WARNING, CAUTION, and NOTE carry special meanings and should be carefully reviewed.
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
900093.W issued 01-JUL-21
Warning: The personal safety of the patient and health professional may be
involved. Disregarding 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.
W
ARNINGS AND
To avoid eye injury, do not look directly into the light beam emitted by the light
guide assembly or light pipe. Extreme long term exposure to bright light may cause
eye injury. Avoid direct exposure to light. The bulb utilized in this system emits UV.
The end of the light guide assembly, without the light pipe adapter, may be hot after
use and may be harmful to skin if touched. Do not operate without light pipe adapter
in place.
The photodynamic light curing system is not suitable for use in the presence of a
flammable or anesthetic mixture. It should not be used in an oxygen enriched
environment.
Disconnect power supply from power outlet prior to any maintenance.
The photodynamic curing system and all associated accessories are for use
exclusively with the IlluminOss Medical Inc Photodynamic Bone Stabilization System.
Do not use the Photodynamic Curing Console, Light Guide, or associated accessories
for any other use.
PHOTODYNAMIC LIGHT CURING SYSTEM INSTRUCTIONS FOR USE
C
AUTIONS
- ILLUMINOSS MEDICAL INC