ArthroCare Quantum RF 12000, Руководство пользователя

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ArthroCare
®
Quantum™ (RF 12000) System and
10
ArthroCare
®
Quantum™ 2 (RF 12000) 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 Quantum
(RF 12000) System and ArthroCare
Quantum 2 System (RF 12000). For specific warnings and precautions,
please refer to the Wand and the Patient Cable Instructions for Use.
WARNINGS

The Quantum (RF 12000) System and Quantum 2 System (RF 12000) are intended for use by healthcare professionals
only. The Quantum (RF 12000) System and Quantum 2 System (RF 12000) may cause radio interference or may disrupt
the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the
Quantum (RF 12000) System or Quantum 2 System (RF 12000) or shielding the location.

Failure to follow all applicable instructions may result in serious surgical consequences.

Explosion Hazard: The following substances will contribute to increased fire and explosion hazards in the operating room:
flammable substances (such as alcohol-based skin prepping agents and tinctures), flammable anesthetics, naturally
occurring flammable gases which may accumulate in body cavities such as the bowel, oxygen enriched atmospheres, and
oxidizing agents such as nitrous oxide (N2O) atmospheres.

Fire Hazard: DO NOT place active accessories near or in contact with flammable materials (such as gauze or surgical
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 instruments 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, possibly requiring
extended surgery for removal.

DO NOT use the ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 System (RF 12000) 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 factors under
the user‟s control. Only persons having adequate training and familiarity with orthopedic
surgery should perform procedures
with the ArthroCare Quantum (RF 12000) System or ArthroCare Quantum 2 System (RF 12000).

Consult medical literature relative to techniques, complications, and hazards prior to performance of any procedure.

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.