Stryker 0502-220-100 Manual Del Usuario página 3

Setup
Warning
1. Remove the electrode from the package and examine it for
damage.
2. Insert the electrode into the working channel of the resectoscope
and ensure that the electrode is securely locked into position by
pulling carefully on the electrode stabilizer sleeve (if applicable).
Do not squeeze the stabilizer sleeve.
3. Attach the resectoscope to the electrosurgical generator according
to the manufacturer's instructions.
4. Attach the ground pad to the patient.
Use
Warning Electrodes are shipped non-sterile. Clean and
sterilize all electrodes prior to use.
1. Insert the combined electrode/resectoscope assembly into the
resectoscope sheath and position it at the point where the initial
application of electrical energy will be delivered.
2. Set the electrosurgical generator at power levels consistent with
standard ablation/resection procedures. Power settings vary
greatly depending on the surgeon's preferences, technique,
type of procedure, type of electrosurgical generator used, and
tip style. As a general guideline, the following power settings
can be used:
• In the "Cut" mode, the power setting should be started low
and increased gradually until the desired electrosurgical effect
is achieved.
Caution In "Cut" mode, never exceed 280W power or
5000V peak voltage, or product failure can result.
• In the "Coagulation" mode, the power setting should be started
low and increased gradually until the desired electrosurgical
effect is achieved.
Caution In "Coagulation" mode, never exceed 200W power
or 5000V peak voltage, or product failure can
result. Caution must be taken to prevent arcing
on high coagulation settings.
• If there is little or no tissue effect, check the generator, power
cables, patient ground, and the electrode.
• The power level can be adjusted and varied slightly for
different patients and also when tissue is being removed
on subsequent sweeps.
3. Maintain constant irrigation through the resectoscope using
a sterile irrigant. Keep the distal tip of the electrode in view
and submerged in the irrigant at all times.
4. Tissue buildup on the electrode tip can affect performance.
Clean the tip with a sterile, lint-free cloth, and/or
a non-flammable cleaning agent.
Warning To avoid user shock and/or burn, turn off the
power to the generator before touching the
electrode.
Reprocessing
These reprocessing instructions are provided in accordance with
ISO 17664. While they have been validated by the manufacturer
of the medical device as being capable of preparing the device for
re-use, it remains the responsibility of the processor to ensure that
the reprocessing as actually performed, using equipment, materials,
and personnel in the reprocessing facility achieves the desired
result. This normally requires validation and routine monitoring
of the process.
Warnings
Use only the sterilization cycles outlined in this document. Using
unspecified sterilization cycles may damage the electrode or result
in incomplete sterilization.
Limitations on Reprocessing
N/A
Instructions
Point of Use
Wipe excess soil from the device using disposable paper towels.
Containment and Transportation
Reprocess the device as soon as reasonably practical following use.
Preparation for cleaning
1. If applicable, disassemble the device.
2. Prepare an enzymatic detergent according to the manufacturer's
recommendations, using tap water at 35 - 40°C.
Do not use the electrode if there are visible signs
of damage, or if the insulation is not intact.
EN-3