S
afetY
3-1
Section 3
s
AFety
OPERATING PERSONNEL
The surgeon using this device should:
• be trained in arthroscopic surgical procedures
• be aware of the risks associated with those procedures
• have current knowledge of technological advances in surgical products and techniques.
WARNING
Hazardous Electrical Output: This equipment is capable of producing a physiological effect and
is for use only by licensed physicians, trained in the use of this device.
WARNING
No modification to the equipment is allowed.
FIRE/EXPLOSION WARNINGS
• As with all electrosurgical devices, do not use in the presence of flammable anesthetics
or oxidizing gases, such as nitrous oxide, oxygen or endogenous gases which have
accumulated in body cavities. An electrosurgical device has the potential for providing
a source for ignition.
• Nonflammable substances should be used for cleaning and disinfecting. Use of
flammable substances, such as alcohol-based skin prepping agents and tinctures
should also be avoided.
• All oxygen connections must be leak free for the duration of the surgical procedure.
Pathways, such as endotracheal tubes, must be leak free and properly sealed to
prevent oxygen leaks.
• Electrosurgical accessories which are activated or hot from use can be a potential fire
hazard if placed near or in contact with flammable materials. Some materials, such as
gauze, cotton or wool, when saturated with flammable liquids, can be ignited by sparks
produced during the normal use of electrosurgical devices.
ELECTRICAL SAFETY CONSIDERATIONS
• Examine all accessories and connections to the VAPR Generator before use. Ensure
that the accessories function as intended. Improper connection may result in arcing,
sparking, or malfunction of the Electrode or Handpiece, any of which can result in an
unintended surgical effect, injury, or product damage.
• Unless specified in the instructions for use accompanying an approved VAPR
accessory, the VAPR System should only be activated with the working tip of the
electrode accessory completely immersed in 0.9% w/v; 150 mmol/l sodium chloride
or Ringer’s lactate solutions. For convenience, these will be referred to within the
remainder of this manual as normal saline or Ringer’s, respectively. Performance will
be suppressed by use of other irrigating solutions such as Glycine, Sorbitol, Dextrose,
Mannitol or other solutions containing a non-physiological concentration of electrolytes.
