Important - LiNA Gold Loop EL-160-4 Manual Del Usuario

IMPORTANT:

• Keep the voltage/power as low as possible to
achieve the desired effect.
• Grounding plate is necessary!
• This device should only be used by persons
qualified in the procedures for which this is
indicated.
INSTRUCTIONS FOR USE:
After the uterine ligaments and vessels have been
correctly ligated, when the uterus can be safely
amputated from the cervix, follow the instructions
below:
1. Apply the grounding plate to the patient and
generator. Connect the LiNA Gold Loop to the
generator's monopolar outlet. Set the generator at
Blend 1 and start at 100 Watt.
2. Carefully insert the LiNA Gold Loop through a 5mm
trocar/entry.
3. Unfold the electrode (loop) by forwarding the
handle. The handle must be completely advanced
and the loop 100% unfolded prior to placing the
loop around the uterine body.
4. Use grasper(s) and the uterine manipulator to help
place the electrode (loop) around the uterine body.
4b. The LiNA Gold Loop should not be used when the
electrode loop is in contact with any organ other
than the uterus.
SYMBOLS USED ON PRODUCT LABELING:
CE mark with number – confirmation of
meeting EU requirements
Manufacturer
LOT
Batch code
Use-by date
Do not reuse
Caution: Federal Law (USA) restricts this device to
LiNA Medical ApS - Formervangen 5 - DK-2600 Glostrup - DENMARK - Tel: +45 4329 6666 - Fax: +45 4329 6699 - e-mail: info@lina-medical.com - www.lina-medical.com
sale by or on the order of a trained physician.
LiNA is a registered trademark of LiNA Medical in EU, US and CN
5. Carefully tighten the loop around lower part of
uterine body (above cervix).
5b. REMOVE the uterine manipulator and slightly
release the tension of the loop.
6. Start sectioning the uterine body by pressing "cut"
on the foot pedal. After 1-3 seconds slowly pull
the handle, until the electrode (loop) has cut the
uterine body and is retracted inside the tube. Stop
pressing the foot pedal.
6b. Before activating the generator always verify
that the active (i.e. un-insulated) portion of the
electrode is not in contact with any organ other
than the uterus (e.g. bowel or vessel).
7. Remove the LiNA Gold Loop through the trocar.
8. Dispose the used LiNA Gold Loop after usage.
• After amputating the uterus from the cervix, ensure
that the proximal portion of the endocervical canal
which may contain endometrial cells is coagulated,
and ensure that any bleeding or oozing on the
cervical stump is coagulated.
• Provide instructions for follow up to patients
in the event of complications including intra
abdominal bleeding which in rare cases can lead to
exsanguinations.
Country of origin: Poland
CE marking 2006.
Sterilized using ethylene oxide
Consult instructions for use
Do not use if package is damaged
Type BF equipment IEC 60601
GB
2017-12 FV0023N