English; Product Description/Intended Use; Prior To Use; During Use - Stryker 0502-220-100 Manual Del Usuario

English

Product Description/Intended Use

Stryker resectoscopic electrodes are monopolar electrodes designed
to deliver high-frequency energy for the cutting and coagulation
of soft tissue. They are intended for use in gynecological and
urological surgery.
There are eight different electrode tip styles that allow the user
to cut, ablate, and vaporize tissue.
Warnings

Prior to Use

1. Federal Law (USA) restricts these devices to use by, or on the
order of, a physician.
2. All medical staff should carefully review product labeling and
this manual before using this product. Inappropriate use of the
electrode could adversely affect the procedure or cause injury
to the patient and/or surgeon.
3. Do not use the electrode if it has breaks, scratches, or cracks in the
insulation. Cracks in the insulation can result in electric current
leakage and may cause unintended electrosurgical burns.
4. To avoid inadvertent shock, place surgical electrode cables in
such a way that any contact with the patient or other cables is
avoided. Store active electrodes in a location isolated from the
patient when not in use.
5. Check the loop prior to use by comparing it to a new loop.
Loops whose wire has become too thin could break and cause
injury to the patient or user.
6. Do not touch the loop to any hard object as this could damage
the loop.
7. When using electrodes with the 22/24 Fr. resectoscope, use only
a 2.9mm, 12° endoscope. Using other scopes can limit visibility
of the electrode tip.
8. Do not bend or change the angle or shape of the distal end of
the electrode. Doing so may cause the tip to break, resulting in
injury to the patient or surgeon, malfunction, or device failure.

During Use

1. Immediately discontinue use and discard the electrode if breaks
or fractures appear in the electrode. These conditions may allow
undirected emission of electrical energy, rendering the device
useless and potentially causing harm to surrounding tissues.
2. To avoid user shock and/or burn, turn off the power to the
generator before touching the electrode.
3. Check all components for damage before increasing the power
output higher than the standard setting. Injury to the patient
can occur.
4. Ensure the electrode has been inserted properly as arcing can
occur in the working element.
5. Avoid activating the HF current if the electrode is in an air or
gas bubble, as this could cause serious injury to the patient and
user or possible explosion.
6. To avoid inadvertent burns during operation with a resectoscope,
make sure that the HF current is activated only under visual
control. Do not activate the electrode continuously for
an unnecessary prolonged period of time.
7. Do not use lubricants on metallic sheaths. Damage can occur
to the electrodes.
8. Use only non-conductive irrigants, such as deionized water,
glycine, and glucose solutions or the electrode will not cut
properly.
9. Maintain constant irrigation during the procedure. The distal
tip of the electrode should be submerged in the irrigant and
kept in view at all times. This will keep the distal tip cool and
the view clear to prevent inadvertent burns and ensure proper
device function.
10. Ensure that the patient does not come into contact with metal
objects that are grounded, as this may result in unwanted burns.
11. Do not allow the patient to have skin-to-skin contact with
himself/herself (such as the bare arms touching the body) as
this may cause unwanted electric current to flow. Use dry gauze
as a separator.
12. Electromagnetic disturbances may occur in other equipment while
using the electrode. If this occurs, deactivate the electrode and
ensure the reading is the result of an actual physiological event.
EN-2