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Caution: Federal Law (USA) restricts this device
to sale by or on the order of a trained physician.
Bipolar Loop
LiNA
BL-160, BL-200, BL-240
Intended Use:
The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended
for amputating the mobilized uterus during laparoscopic supracervical
(subtotal) hysterectomy and resection of devasculated subserosal
pedunculated myomas. To be used with an electrosurgical generator.
Contraindications:
The LiNA Bipolar Loop should NOT be used in the following situations:
•
If the uterine isthmus cannot be visualized circumferentially before
activation.
•
If the uterus or myoma is adhered to any adjacent organs.
•
If the patient has a large posterior uterine or cervical wall myomas.
•
Amputation of uterus which is larger than a gestational week of 20.
Warnings:
•
The LiNA Bipolar Loop is supplied STERILE using an ethylene oxide
process. Carefully inspect the packaging for any damage prior to use.
Do NOT use if sterile barrier is damaged. Do NOT use past expiration
date.
•
For single use ONLY.
Do NOT reuse, reprocess or re-sterilize the LiNA Bipolar Loop. Any
reprocessing may impede the functions of the device. Reusing
single use devices may also increase the risk of cross contamination.
Attempts to clean the device results in risk of device malfunction
and/or erroneous pathology specimen collection due to residual
tissue in the LiNA Bipolar Loop.
•
Do NOT use the device when in the presence of flammable gases or
flammable fluids.
•
Do NOT use if the LiNA Bipolar Loop is bent, twisted, malformed, or
does not unfold completely to the original rhomboid design when
the handle is completely advanced.
•
Do NOT modify the original rhomboid design of the LiNA Bipolar
Loop.
•
The LiNA Bipolar Loop must be large enough to pass around the
corpus of the uterus or the myoma. Then apply the loop around the
cervix or the myoma stalk.
•
Always verify that the active (i.e. un-insulated) part of the electrode
is not in contact with any organ other than the uterus or myoma (e.g.
bowel or vessel) before activating the generator.
•
Do NOT activate the LiNA Bipolar Loop if it is not possible to visualize
the cutting loop.
•
REMOVE the uterus manipulator before activating the
LiNA Bipolar Loop. Only a uterus manipulator made of NON-
CONDUCTING material (e.g. plastic) should be used with the LiNA
Bipolar Loop.
•
REMOVE intra uterine device (IUD) from the uterus prior to
activating the LiNA Bipolar Loop.
•
The LiNA Bipolar Loop should NOT be used in patients where the
bladder cannot be completely dissected at the lower anterior uterine
segment due to the risk of bladder injury.
•
Do NOT allow the cable of the LiNA Bipolar Loop to be in contact
with skin of the patient or surgeon during electrosurgical activation.
•
Do NOT use excessive force/load to the LiNA Bipolar Loop. This
could damage the product or result in strangulation and mechanical
sectioning of the uterus or myoma with the risk of excessive
bleeding.
•
Be sure to activate the electrode prior to retracting the LiNA Bipolar
Loop. Failure of activation can result in mechanical sectioning of the
uterus or myoma with the risk of excessive bleeding.
•
Do not use the LiNA Bipolar Loop for slicing the uterus or myoma as
alternative to morcellation.
•
Be sure that the ceramic tip is fully retracted into the shaft /tube prior
to extracting the LiNA Bipolar Loop through the trocar to prevent the
ceramic tip from getting caught in the flap of the valve.
•
After use, dispose of product and packaging in accordance with
hospital, administrative and/or local government policy.
•
DO NOT activate if the uninsulated wires of LiNA Bipolar Loop are in
contact with metal objects.
Precautions:
Use of the LiNA Bipolar Loop requires adequate training and experience
in performing laparoscopic hysterectomy and myomectomy.
Failure to carefully follow all applicable instructions may result in
significant injury to the patient, physician or attendants and may have
an adverse effect on the outcome of procedures performed.
Precautions should be taken when the patient has any implanted
electronic device (IED). The perioperative team should consult with the
team managing the implanted device before surgery and as needed.
When LiNA Bipolar Loop is activated it should be kept more than ½ inch
(1 cm) from the IED.
Carefully use the LiNA Bipolar Loop with other sharp tools as wire's
insulation damage can lead to device malfunction.
Product description:
The LiNA Bipolar Loop consists of a black outer-tube and a blue inner-
tube at which the handle of the device is attached. The rhomboid loop
is fastened to the inner-tube and is advanced by holding the upper
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
LiNA is a registered trademark of LiNA Medical in EU, US and CN
TM
TYPE BF
STERILISED USING EtO
DO NOT REUSE
EQUIPMENT
part of the black outer-tube while pushing forward the blue handle.
To retract the loop, gently pull the blue handle with one hand while
holding the black outer-tube with the other.
Generator specifications & settings:
The LiNA Bipolar Loop is compatible with most standard electrosurgical
generators with bipolar outlet (fixed 2-pin 4mm plug with a 29mm
distance).
•
The recommended setting for the generator is 55-70 Watts. Use the
lowest possible settings capable of achieving the desired surgical
effect.
•
Use a bipolar foot pedal.
•
Use only electrosurgical generators working in the frequence field
350 to 472KHz as a minimum covering the power range 55-70 Watts
of bipolar energy.
Instructions for use:
This information is provided for using the LiNA Bipolar Loop. It is not
intended to demonstrate laparoscopic techniques or procedures.
Consult published and recognized medical literature for appropriate
techniques, complications, and hazards prior to doing any laparoscopic
procedure. Consult the instructions for use provided by the
manufacturer of the electrosurgical generator and/or laparoscope to be
used for contraindications.
Read the instruction for use prior to use of this device!
After the uterine ligaments and vessels have been correctly ligated,
the uterus can be amputated from the cervix or the myoma from
the stalk, following the instructions below:
1. Carefully inspect the packaging for any damage prior to use. Do NOT
attempt to use the device if sterile barrier is damaged.
2. Connect the LiNA Bipolar Loop to the generator's bipolar outlet. Set
the generator between 55-70 Watts depending on type of generator.
3. Carefully introduce the LiNA Bipolar Loop through a 5mm trocar.
4. a. 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 or myoma.
b. Use grasper(s) and the uterine manipulator to assist placing the
electrode (loop) around the uterine body or myoma.
5. Before activating the generator always verify that the active (i.e. un-
insulated) portion of the electrode is not in contact with any organ
(e.g. bowel or vessel) other than the uterus or myoma.
6. a. Carefully tighten the loop around the lower part of uterine body
(above cervix) or myoma stalk.
b. REMOVE the uterine manipulator by slightly releasing the tension
of the loop.
7. a. Activate the LiNA Bipolar Loop by pressing the bipolar pedal. Be
sure to await the bipolar energy before sectioning the uterus or
myoma. Immediate retraction of the loop may inflict an unintended
mechanical cut.
b. After amputating the uterus or myoma, do not activate the
electrodes to manipulate or divide the uterus or myoma.
8. 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.
9. Remove the LiNA Bipolar Loop through the trocar.
10. Dispose the LiNA Bipolar Loop after usage.
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 2012.
2018-06 FV0137G
GB
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