© GENICON
©
X-SurgeShaftHandle_AC
Page 3 of 25
1.
Ensure the handle has been cleaned and sterilized in accordance with below procedure prior to use.
2.
Inspect the unit for defects
– do not use if unit is defective.
Refer to picture -
1
-
A.
Rotation Knob
B.
Monopolar Post
C.
Trigger
3.
Open the handle to fully extend the attachment socket.
Refer to picture
2
-
4.
Align the Ball Joint of the shaft and insert into the exposed attachment socket of the handle. The shaft is to be parallel to the working length of the handle.
Refer
to picture
3
-
5.
Close handle to temporarily secure the shaft in place, and slide the Locking Knob to the proximal end of the shaft.
Refer to picture
4
-
6.
Rotate the Locking Knob clockwise until tightened to handle, ensure fit is secure.
Refer to picture
5
-
7.
When attaching a mono-polar generator cable to the cautery connector located on the top of the instrument
use an electrosurgical cable that has a 4mm
female connector
and follow the generator manufacturer’s instructions for use and setup.
Refer to picture
6
-
8.
Using the handle, open the tip to full aperture and verify proper assembly and working condition.
Refer to picture
7
-
9.
Keep the contact surface of the instrument clean during the operation. Wipe off any dried residue.
10. The tip mechanism is designed to open and close smoothly. Care should be taken not to forcibly open the jaws wider as undue stress may damage the
insulation, or jaw components.
CLEANING & STERILIZATION
WARNING:
Failure to following the below instruction or the use of other cleaning/disinfecting agents, settings, methods, or material other than specified may result
in incomplete cleaning and/or sterilization and may cause degradation of the instrument material resulting in premature failure of the device.
LIMITATIONS ON PROCESSING:
Repeated processing according to the below instructions has minimal effect on these devices. End of life is normally determined
by wear and damage due to use as determined by inspection and functional testing. Evidence of damage and wear on a device may include but is not limited to
signs of excessive surface damage (i.e. crazing, cracks, flaking, scratches, discoloration, delamination), broken or damaged parts (i.e. distorted, warped, bent),
corrosion of the metallic components (i.e. rust or pitting), missing or removed (buffed off) part numbers/identifiers, failure to pass electrical safety testing, and binding
of movable parts (i.e. excessive friction, grinding, freezing). Devices that do not meet the inspection and function testing should not be used.
INSTRUCTIONS
Initial treatment at the point
of use
1.
Immediately after a procedure, remove gross/heavy soiling from the device using a soft brush or lint-free cloth and rinse
with tap water. To ensure adequate cleaning, it is imperative that the instrument not be allowed to dry soiled.
2.
Remove and discard the insert if attached.
3.
Contain and transport the instrument to the decontamination area for cleaning.
Preparation before cleaning
The insert must be removed and discarded prior to cleaning.
Cleaning: Automated
WARNING:
Use of automated cleaning equipment is NOT recommended for these instruments.
Cleaning: Manual
WARNING:
Wear personal protective equipment such as protective gloves, clothing and face masks during cleaning and drying
of contaminated instruments to reduce the risk of infection or personal injury.
1.
Thoroughly rinse the instrument to remove all gross debris.
2.
Completely immerse the instrument in a mild/neutral pH enzymatic cleaning solution (e.g. Enzol) and scrub thoroughly
using a soft brush to remove any residual blood, protein material and contaminants from the instrument. Follow the cleaning
solution manufact
urer’s instructions for concentration, temperature and contact time.
NOTE:
Cleaning brushes should be cleaned and disinfected/sterilized after each use to prevent cross contamination
3.
Thoroughly rinse the instrument using distilled or demineralized water until any debris or detergent which could interfere
with sterilization is removed.
Disinfection
WARNING:
Use of high-level disinfection is NOT recommended for these instruments.
Drying
Dry the device using an absorbent lint-free cloth until visible moisture is removed.
Maintenance, Inspection
and Testing
After cleaning, but prior to sterilization, inspect the instrument for cleanliness and damage. Lubricate all moving parts of the
device with a water soluble lubricant such as instrument lubrication milk.
Packaging
After inspection and lubrication, the device should be appropriately packaged for sterilization using only materials indicated for
the sterilization process detailed below.
Sterilization
Sterilize devices using the following steam sterilization cycle:
Sterilization Method
Gravity Cycle
Temperature
132 °C
Steam/Hold Time
3 minutes
At the completion of the sterilization cycle, all instruments should remain untouched until adequately cooled.
Storage
Store all sterile devices in a dry, clean and dust free environment as specified in the above section.
Additional Information
The instructions provided above have been validated by GENICON as being capable of preparing a medical device for reuse. It
remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and
personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring
of the process.
DE
– GERMAN
LESEN SIE DIE FOLGENDEN INFORMATIONEN GRÜNDLICH, BEVOR SIE DIESES PRODUKT VERWENDEN.
WICHTIG!
1.
Diese Broschüre dient dazu, Sie bei der Anwendung dieses Produkts zu unterstützen. Es ist kein Nachschlagewerk für chirurgische Verfahren.
BESCHREIBUNG
Die monopolaren laparoskopischen Instrumentengriffe von GENICON X-Surge sind wiederverwendbare monopolare Griffe, die nicht sterile verpackt sind und in
Kombination mit einem kompatiblen Einsatz (separat erhältlich) verwendet werden. Es umfasst Greifer, Dissektoren und Scheren, um weiches Gewebe zu erfassen,
zu manipulieren, zu schneiden und zu kauterisieren (Einsatz erforderlich).