• Connect bipolar accessories to the bipolar receptacle only.
Improper connection of accessories may result in inadvertent
accessory activation or other potentially hazardous conditions.
• Always follow the electrosurgical unit manufacturer's instructions
for operation of the electrosurgical unit to prevent unnecessary
hazard to the operator and/or the patient.
• Consult the endoscope manufacturer's instructions for use
concerning proper grounding of the endoscope.
• Make certain the instructions for use provided with the Habib
EndoHPB Catheter are followed to perform the procedure.
• Position the Adaptor Cable Bipolar to avoid contact with the
patient or other leads.
• Store the Adaptor Cable Bipolar in a location isolated from the
patient when not in use.
• Dispose of product and packaging in accordance with hospital,
administrative and/or local government policy after use.
ADVERSE EVENTS
None known.
HOW SUPPLIED
The Adaptor Bipolar is supplied Non-Sterile. Do not use if package
is damaged or unintentionally opened before use. Do not use if
labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
DIRECTIONS FOR USE
1. Open the package and remove the Adaptor Cable Bipolar from
the package.
2. Inspect the Adaptor Cable Bipolar for signs of damage.
3. Inspect cord insulation, male connector and female connector
for cracks, holes, burns, nicks voids etc. (do not use cords which
show any sign of damage or deterioration).
4. Attach the male end of the cord to the electrosurgical generator.
5. Connect the female connector of the Adaptor Cable Bipolar to the
Habib EndoHPB Catheter, by grasping connector bushing and
fully seating the plug so no pin is visible. Consult Habib EndoHPB
Catheter instructions for use for additional instructions.
WARNING: Attach/detach the cord only while the generator
is in the "OFF" or "STANDBY" mode. Failure to do so may
result in injury or electrical shock to the patient or operating
room personnel. Consult active device instructions for use for
additional instructions.
6. Follow the electrosurgical unit manufacturer's instructions for
operation of the electrosurgical unit and follow the directions
for use provided with the Habib EndoHPB Catheter to perform
the procedure.
7. Detach the male end of the cord from the electrosurgical
generator by grasping the plug bushings (never remove by
pulling on insulated cable).
8. Detach the female connector of the Adaptor Cable Bipolar from
the Habib EndoHPB Catheter.
9. Immediately after use remove excess soil with disposable
cloth/paper wipe.
Note: It is recommended that devices are cleaned as soon as is
reasonably practical following use.
3
Black (K) ∆E ≤5.0