Warnings, Precautions, And Adverse Events; Warnings; Precautions - smith&nephew ArthroCare Atlas Manuel De L'opérateur

10 ArthroCare
Atlas™ System
®
User's Manual

Warnings, Precautions, and Adverse Events

The following is a list of Warnings and Precautions that apply to the general operation of the ArthroCare Atlas
System. For specific warnings and precautions, please refer to the Wand and the Patient Cable Instructions for Use.

WARNINGS

• Failure to follow all applicable instructions may result in serious surgical consequences.
• Fire Hazard: DO NOT place active accessories near or in contact with flammable materials (such as gauze or sur-
gical drapes).
• Electrosurgical accessories, which are activated or hot from use, can cause a fire.
• Accessory tips may remain hot enough to cause burns after the electrosurgical current is deactivated.
• Inadvertent activation or movement of Wands outside the field of vision may result in injury to the patient.
• Localized burns to the patient or physician may result from electrosurgical current carried through other instru-
ments and conductive objects.
• Electrosurgical current may be generated in conductive objects by direct contact with the active electrode or by
the active or return electrode being in close proximity to a conductive object.
• If excessive heating or physical forces cause damage to the Wand tip, foreign body fragments may result, possi-
bly requiring extended surgery for removal.
• DO NOT use the ArthroCare Atlas System with non-conductive media (e.g. sterile water, dextrose, air, gas,
glycine, etc.). Use only conductive media such as normal saline or Ringer's lactate.
• Electric Shock Hazard: DO NOT connect wet accessories to the Controller.
• Controller failure could result in an unintended increase in output power.

PRECAUTIONS

• Prior to initial use, ensure that all package inserts, warnings, precautions, and Instructions for Use are read and
understood.
• Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on fac-
tors under the user's control. Only persons having adequate training and familiarity with orthopedic surgery
should perform procedures with the ArthroCare Atlas System.
• Consult medical literature relative to techniques, complications, and hazards prior to performance of any proce-
dure.
• Evaluate patients for predisposing medical problems that may be aggravated by the stress of surgery.
• A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to
avoid shock and burn hazards to both patient and medical personnel and damage to the device and other medical
instruments. Ensure that insulation or Controller grounding is not compromised.
• When instruments and accessories from different manufacturers are employed together in a procedure, verify
compatibility prior to initiation of the procedure.
• When not in use, remove the Wand from the surgical site and place away from metallic objects. Wands should
remain separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices.
Inadvertent activation may cause injury to patient and/or user or equipment damage.
• DO NOT wrap Patient Cable around metal objects. Wrapping cords around metal objects may induce currents
that could lead to shocks, fires, or injury to the patient or surgical personnel.