It has been determined that insulation failure of active electrode surgical probes (bipolar and monopolar) is one of the major reasons why patients receive electrosurgical burns to unintended tissues. Even the smallest hole in the insulation of the probe will endanger the patient’s safety since the escaping electrical energy will usually cause burns to the patient outside of the surgeon’s view. ONLY visually inspecting the integrity of the probe’s insulation will often miss the small holes and cracks that occur.
While much care is taken in the handling of these probes they are still subjected to mechanical stress due to the sterilization methods or cleaning agents used, such as alcohol or glutaraldehyde.
- These mechanical stresses can produce pinholes, nicks or cracks in the protective insulation of the probe.
- Handling of the electrode surgical probe during the surgery may also cause damage to the insulation.
- There is also a possibility of defects caused to the probe during packaging or that may occur to it during or after being shipped from the manufacturer.
Yes, any conductive element with coating can be tested providing that the conductive element is easily accessible. For example, EKG, EEG probes.
A vigorous program of regular inspection of probes’ insulation should be practiced. Formal procedures should be set-up to minimize the potential damage to the probe’s insulation. This procedure should incorporate the probe’s insulation testing on a regular basis. One of the best and most cost effective way to test the probe’s insulation’s integrity is to utilize the McGan integrity testing units. It is recommended by Standard Organizations that the probe be tested post-surgery in the Sterile Department after the probe has been cleaned and just prior to sterilization.
The unit is a low frequency high voltage generator that delivers a stabilized preset DC output via a probe to an inspection electrode. As the electrode moves over the coating surface, if it encounters a pin hole or bare spot, a small current flows actuating a visible (non-hazardous) spark at the point of contact and a visible and audible alarm is activated in the unit.
The voltage required is pre-set manually on the unit to a minimum level determined by the thickness of film of the coating product and its generic type i.e.: PVC, Teflon, FRP or polyethylene. Detailed instructions are set out in the section of the Operator’s Manual marked Recommended Minimum Voltage. It is important to follow these instructions in setting voltages as some surfaces have a much higher dielectric strength than others – consequently offering a high resistance to the conduction of electricity. Applied test voltages should only be sufficient to detect faults, otherwise overstressing of the dielectric strength may occur with possible surface rupturing.
This depends on the type of coating applied.
As wet surfaces are generally conductive, this could affect the unit operationally.
Atmospheric moisture is unlikely to do so.
No! The applied voltage to the coating is non-destructive, provided the voltage applied is within the parameters set down in the Recommended Minimum Voltage section of this Operator’s Manual for the type and thickness of coating.
Since the test instrument found a defect it does not matter if the spark causes slightly more damage as the instrument should not be used. Note: The smaller the crack or pinhole in the insulation the more damage it may cause to the unintended tissue.
No! Under normal operating conditions the user should not be handling the ends of the ground wire and the electrode wire at the same time. If this occurs then only a mild tingle will be felt by the operator. Wear gloves to prevent any occurrence.
How does the size of the hole, or defect, in the insulation of electrosurgical instrument effect the leak of the RF voltage?
The smaller the hole, the crack or defect the more concentrated the voltage the more potential for a deeper non-intended tissue burn
There are three types of electrodes that are offered by McGan and they are easily interchanged to obtain the best detection results on various electrosurgical instruments.
- The Ring electrode is used to test circular (rod) type instrument (e.g. laparoscopic instrument) and provides 360 degree results as long as the wires in the ring are in or close proximity to the insulation.
- The Brush electrode is used to test areas of electrosurgical instruments or a flexible or non-circular instruments that cannot be tested by the ring or Tri-Hole electrode. For example, these include bi-polar forceps, endoscopic, or other non-circular insulated instruments.
- The Tri-Hole electrode is used to test circular (rod) type instruments (e.g. laparoscopic instrument) that has a diameter of 3, 5 or 100mm. It will provide 360 degree results as long as the diameter of the instrument is in contact or very close proximity to the conductive core within the hole. Note: The spark is contained within the hole and therefore cannot been seen however the alarm sounds and alarm indicator flashes on test unit when a defect is detected.
Subject to the warranty conditions noted in the full Operator’s Manual each product base unit is warranted by the Manufacturer to be free from defects arising from faulty design, material, or workmanship for a period of 12 months from the date of original purchase by the user.
Electrodes (Probes) and leads are warranted for 2 months. They are consumable items, and subject to wear and deterioration during use. The life of these parts can be extended by keeping them in a clean and dry condition. The probes and leads must be stored in suitable protective containers. During use, avoid “scrubbing” the probe along the surface of the work-piece.
Both the McGan Integrity Tester base unit operate on battery power and therefore do not need to be UL certified, The battery adapters are UL certified and are so marked.
Yes they are very easy to set up in usually less than 2 minutes and the key parts are color coded to avoid any issue. Example: Green wire to green port- Red wire to red port, insert the chosen electrode into the handle (or base unit of the Handle-held unit), set the kilovolts if needed to the correct setting for the devise under test. Begin testing
Various electrosurgical instruments use different insulation (jacketed) material and thicknesses. See the information for use (IFU) for the specific unit you are using
With 10’s of thousands of unwanted electrosurgical burns occurring every year it is essential to reduce this number to protect the hospital and the physician from liability issues but more importantly to protect the patient from the numerous side effects from these types of burns and the associated costs to the hospital for the extra care required for these cases.