Warnings And Precautions - DePuy Synthes SPOTLIGHT Manual Del Usuario

been used to describe the risks associated with conventional surgical intervention. Additional risks
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associated with the use of the SPOTLIGHT Access System, other than those described for surgery in
general, may be instrument malfunction, such as bending, fragmentation, loosening and/or breakage
(whole or partial). Breakage in the patient may increase surgical time since this instrument should not
be implanted. Also, surgery may not be effective. Similar risks are associated with the system use
in any part of the body.
Additional risks are attendant to surgery and the use of anesthesia, etc., and are not directly related
to the use of the retractor. These include, but are not limited to:
•
Pneumonia,
•
Phlebitis,
•
Embolism,
•
Wound infection, or
•
Blood loss with or without anemia.

WARNINGS AND PRECAUTIONS

•
Proper selection of the patient and the compliance of the patient will greatly affect the results.
•
Ensure the packaging is not damaged prior to use.
•
Improper use of this instrument may cause injury to the patient. Due to the Illuminated port's ability
to transmit radiant energy from high intensity surgical lightsources, soft tissues, which are located
proximal to the port tip and exposed to this energy, may reach temperatures above 41°Celsius
(106°F). The operator of the port should control the output of the lightsource so as to provide only
as much light as necessary for visualization during procedure and furthermore, irrigate the soft
tissues exposed to the radiant energy to reduce any risk of tissue damage.
•
The connection point between the Illuminated port and light cable and lighted retractor blade and Y
cable may also become hot during use. These connections should be handled with caution during
port/retractor manipulation in-situ or while disconnecting the light transferring cable from the port
or Y cable from the lighted retractor blade.
•
The retractor port tips are thin-walled and should not be dropped or bent at a sharp angle.
•
Proper, secure component connections must be made to assure proper functioning of all aspects
of this device.
•
Components of this system should be thoroughly inspected during cleaning and prior to surgery
for possible damage.
•
Do not ultrasonically clean any instruments with integrated fiber optics as this may potentially
decrease the instrument life.
•
Components should not be immersed in cold water immediately following autoclave as this could
cause fiber breakage and decreased performance.
•
Care should be exercised when high speed drills are used inside the access port or retractor as
damage to the inner walls and tip or retractor blades may occur upon contact.
•
The handle of the F2 washer ports is not designed to be used with rigid fixation.
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