Boston Scientific Active Cord Instrucciones De Uso página 3

HOW SUPPLIED
The Active Cord 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 Active Cord from the package.
2. Inspect the Active Cord 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. Connect the female connector of the Active Cord to the active
device, by grasping connector bushing and fully seating the
plug so no pin is visible. Consult active device instructions for
use for additional instructions.
5. Attach the male end of the cord to the electrosurgical generator.
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 instructions for
use provided with the active device 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 Active Cord from the active device.
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.
CLEANING INSTRUCTIONS
Point of Use:
Remove excess soil with disposable cloth/paper wipe
It is recommended that devices are cleaned as soon as is reasonably
practical following use.
Cleaning
Equipment: brush or cloth, running water, mild detergent
1. Rinse excess soil from instrument using warm (not hot) water.
2. Using a brush or cloth, apply detergent solution to all surfaces
(cord, bushings, plugs). Pay particular attention to recessed
areas in the instrument plug/bushing assembly.
3. Rinse thoroughly under clean running water.
4. Product must be thoroughly dried before storage and/or use.
Maintenance, Inspection and Testing:
• Inspect cord insulation, male connector and female connector
for cracks, holes, burns, nicks, voids, etc. (do not use cords which
show any damage or deterioration).
• Connect cord to instrument and electrosurgical unit by grasping
connector bushings and fully seating conductive plugs.
Packaging:
The Active Cord may be replaced in the original packaging or similar
after cleaning.
Sterilization:
Product is not recommended to be sterilized.
Disposal
Disposal Instructions:
1. Clean and disinfect all external and accessible surfaces using the
cleaning and disinfection instructions included in this DFU.
2. Use an electronic recycle facility to dispose of the Active Cord.
a. Use of recycling service suppliers familiar with medical
electrical equipment is recommended, but not required. Do
not dispose of by incineration, burial or placement into a
common waste stream.
Post-Procedure
Any serious incident that occurs in relation to this device should be
reported to the manufacturer and relevant local regulatory authority.
3
Black (K) ∆E ≤5.0