Warnings And Cautions - Stryker Formula Manual Del Usuario

Warnings and Cautions

Warnings
To avoid potential serious injury to the user and the patient and/or damage
to this device, the user must obey the following warnings:
Prior to Surgery
• Federal law (United States of America) restricts these devices to use by,
or on order of, a physician.
• To avoid potential serious injury to the user and patient and/or damage
to these devices, read this user guide and the user guides for other
components, namely the console, the footswitch, and the cutting
blade thoroughly and be familiar with its contents prior to using this
equipment.
• Before using the handpieces in a surgical procedure, inspect it for
any damage. Ensure that there are no loose or missing components
and that all parts move freely. Do not use the equipment if damage is
apparent.
• Set up the entire system and verify each function before introducing a
handpiece to the surgical site.
• Clean and sterilize the handpiece prior to the first use and every use
thereafter.
During Surgery
• The handpieces are designed to be used by a qualified physician
familiar with arthroscopic procedures. Misusing the handpieces may
cause damage to both the patient and system components.
• The handpieces generate electronic noise that may interfere with EKG
readings. Should EKG readings become erratic while a handpiece is in
use, power down the handpiece before reacting to the EKG reading,
to ensure the electronic interference is not causing inaccurate EKG
readings.
• Do not operate the handpiece unless the shaver blade is immersed in
solution and suction is activated (at least 5 in. Hg). Failure to do so may
result in abnormal wear of the cutting surfaces, overheating, particulate
generation, and accumulation of unwanted materials in the surgical
site.
EN-3