S
afetY
3-3
DURING SURGERY
NOTE
For the purposes of safety procedures, and despite the absence of a conventional return pad, the
VAPR System should still be treated as a high power electrosurgical device.
WARNING
Failure of the HF surgical equipment could result in an unintended increase or decrease in output
power, change in output waveform characteristics or absence of electrosurgical output.
Operator Safety Warnings
• Observe extreme caution when using electrosurgery in close proximity to or in
direct contact with any metal objects. The majority of arthroscopes and arthroscopic
instruments are metal. Do not activate the electrode while any portion of the electrode
tip is in contact with another metal object; localized heating of the electrode and the
adjacent metal object may result in product damage.
• Do not wrap Handpiece, Footswitch or Generator power cord around metal objects.
Wrapping cables around metal objects may induce currents that could lead to shock,
fire or injury to patient or surgical personnel.
• During an electrosurgical procedure, the patient should not be allowed to come into direct
contact with grounded metal objects such as surgical table frame, instrument table, etc.
• Confirm proper default generator power settings before proceeding with surgery.
Always check that the automatic default settings shown on the display match those
indicated on the package insert of the Electrode being used.
• Caution should be used when overriding the default power settings. Use the lowest
power setting and the minimum tissue contact time necessary to achieve the
appropriate surgical effect.
• Visually inspect the Handpiece and Electrode to ensure that they are clean and dry
and free of damage prior to inserting the Electrode. Damage to the connectors or the
presence of fluid may cause a hazardous electrical short.
• Ensure that the Electrode is fully seated in the handpiece prior to use. Improper
connection could result in non-activation of the Electrode and fluid leakage which may
produce an electrical short.
• Ensure that electrodes with integrated cables are properly connected to the generator,
and that the correct default settings are displayed.
• Introducing the Electrode without an instrument cannula may result in tissue injury and/
or product damage.
• Do not insert, withdraw or touch the active tip of the Electrode when power is
being applied.
• When not in use, place the active Electrode in a clean, dry, nonconductive, and highly
visible area not in contact with the patient. Inadvertent activation while in contact with
the patient may result in burns.
• All high frequency electrosurgical devices can potentially cause muscle stimulation
during use. System design minimizes this effect, however, muscle stimulation may
cause unexpected movement of the patient within the surgical field.
• Skin-to-skin contact (for example between the arms and body of the patient) should be
avoided by, for example, insertion of dry gauze.
Operator Safety Cautions
The VAPR 3 system contains an over-current alarm. If this is heard during activation, the
electrode and handpiece must be withdrawn and inspected for damage. An accessory
that causes repeated over current alarms (when not in contact with a metal surface/
object) should be discarded.
