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Gold Loop
LiNA
TM
EL-160-4, EL-160-8, EL-200-4, EL-200-8, EL-240-4, EL-240-8
IMPORTANT:
• Do NOT allow the cable of the LiNA Gold Loop to
This information is provided for using the LiNA Gold
be in contact with skin of the patient or surgeon
Loop. It is not intended to demonstrate laparoscopic
during electrosurgical activation.
techniques or procedures. Consult published and
• The LiNA Gold Loop shall be used with monopolar
recognized medical literature for appropriate
electrosurgical units, with a maximum operating
techniques, complications, and hazards prior to
voltage not exceeding 2.5kV peak, and may only
doing any laparoscopic procedure. Consult the
be used with a EN-60601-1 approved generator.
instructions for use provided by the manufacturer of
• The LiNA Gold Loop must be large enough to pass
the electrosurgical generator and/or laparoscope to
around the corpus of the uterus. Then apply the
be used for contraindications.
loop around the cervix.
• The LiNA Gold Loop should not be used when the
The LiNA Gold Loop is in compliance with Standard
electrode loop is in contact with any organ other
IEC 60601-1, 60601-2-2 & 60601-2-18.
than the uterus.
• The LiNA Gold Loop must not be pre-tested up
Read the instruction for use prior to use of this device!
against bodily tissue prior to any cutting process.
• Always verify that the active (i.e. un-insulated)
INDICATIONS:
portion of the electrode is not in contact with any
The LiNA Gold Loop is a 5mm monopolar
organ other than the uterus (e.g. bowel or vessel)
electrosurgical device intended for cutting and
before activating the generator.
removal of soft tissue in gynaecological procedures
• Do not activate the LiNA Gold Loop if it is not
involving endoscopic hysterectomy. It is used with
possible to visualize the cutting loop.
standard electrosurgical generators.
• REMOVE the uterus manipulator before
activating the LiNA Gold Loop. Only a uterus
CONTRAINDICATIONS:
manipulator made of NON-CONDUCTING material
The LiNA Gold Loop should not be used in the
(e.g. plastic) should be used with the LiNA Gold
following situations:
Loop.
• If the uterine isthmus cannot be visualized
• Do not use if the loop is bent, twisted, malformed,
circumferentially before activation.
or does not unfold completely to the original
• If the uterus is adhered to any adjacent organs.
rhomboid design when the handle is completely
• If the patient has a large posterior uterine or
advanced.
cervical wall myomas.
• The LiNA Gold Loop should not be used in patients
• Removal of uterus which are larger than
who have undergone caesarean delivery due to
a gestational week of 20.
the risk of bladder injury in the event that the
• Removal of uterus which is attached to the pelvis
bladder cannot be completely dissected off of the
with large laterally fibroids.
lower anterior uterine segment.
• No modification of this equipment is allowed.
WARNINGS:
• After use, dispose of product and packaging in
• The LiNA Gold Loop is supplied STERILE using an
accordance with hospital, administrative and/or
ethylene oxide process. Do not use if sterile barrier
local government policy.
is damaged.
• Carefully inspect the packaging for any damage
Precautions: Use of the LiNA Gold Loop requires
prior to use. Do NOT use if the packaging is
adequate training and experience in performing
damaged.
laparoscopic myomectomy and hysterectomy.
• For single use only. Do NOT reuse, reprocess or
The user must be trained and competent in the basics
re-sterilize this device. Any reprocessing may
of HF surgery and safety precautions that apply to the
impede the functions of this device. Reusing
use of HF surgery.
single use devices may also increase the risk of
Precautions should be taken when the patient has any
cross contamination. Attempts to clean the device
implanted electronic device (IED).
results in risk of device malfunction.
• Do NOT use if the LiNA Gold Loop is damaged.
GENERATOR SPECIFICATIONS:
Carefully inspect the device for unintended
The LiNA Gold Loop is compatible with all standard
rough surfaces, sharp edges, protrusions or other
electrosurgical generators with monopolar outlet and
damages prior to usage. Make sure the shaft is not
BLEND modes.
bended. Dispose of the product if any damage is
discovered.
GENERATOR SETTINGS:
• Do NOT use the LiNA Gold Loop when in the
The recommended setting for the generator is 100-
presence of flammable material or flammable
130 Watt, Blend 1. Max. voltage 2500 Vp-p.
gasses/fluids.
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