LiNA Xcise Handbuch Seite 2

Caution: Federal Law (USA) restricts this device
to sale by or on the order of a trained physician.
LiNA Xcise
Laparoscopic Morcellator
Ref: MOR1515-1-I, MOR1515-6-I
Intended Use:
The LiNA Xcise, Laparoscopic Morcellator is intended for
gynaecologic use by trained professionals in hospital and
surgical environments.
Indications:
Indicated for cutting, coring and extracting tissue in operative
laparoscopy, including gynaecologic procedures such as
hysterectomy and myomectomy.
Contraindications:
Contraindications for use on vascularised tissue (ovaries,
fallopian tubes, myomas and other structures): must be
devascularised before morcellation.
Laparoscopic power morcellators are contraindicated in
gynecologic surgery in which the tissue to be morcellated is
known or suspected to contain malignancy.
Warnings:
Laparoscopic power morcellation may lead to dissemination
of benign or malignant tissue. Uterine tissue may contain
unsuspected cancer. The use of laparoscopic power
morcellators during fibroid surgery may spread cancer, and
decrease the long–term survival of patients. This information
should be shared with patients when considering surgery with
the use of these devices.
• The LiNA Xcise is provided STERILE. Carefully inspect the
packaging for any damage prior to use. Do NOT attempt
to use the device if sterile barrier is damaged. Do NOT use
past expiration date.
• For single use only. Do NOT reuse, reprocess or re-sterilize
the LiNA Xcise. Any reprocessing may impede the functions
of this 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 Xcise causing significant gas leakage through the
morcellator.
• In order to prevent injuries to surrounding viscera exercise
caution while manipulating the LiNA Xcise. Do NOT place
the cutting tip nearby or in contact with tissue which is not
intended to be morcellated.
• Be aware that the cutting tip of the LiNA Xcise is NOT in
contact with other instruments.
• Do NOT activate the LiNA Xcise if it is not possible to
visualize the cutting tip.
• Do NOT attempt to sharpen or modify the cutting tube.
Modified or distorted cutting tube can result in patient,
surgeon or equipment damage.
• After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
Be aware of sharp edges.
Precautions:
For further clarification, the LiNA Xcise should not be used
without appropriate patient selection and pre-operative
diagnostics.
Note that certain types of cancer may not be detectable in
such pre-operative diagnostics potentially leading to spreading
cancer and thereby potentially decreasing the long–term
survival of the patient. The trained professional performing
the surgery is responsible for obtaining the patient's written
informed consent on this information.
24 November 2014, the US FDA recommended manufacturers
of laparoscopic power morcellators to include the following
contraindication in their IFU: Laparoscopic power morcellators
are contraindicated for removal of uterine tissue containing
suspected fibroids in patients who are:
• peri– or post–menopausal, or
• candidates for en bloc tissue removal, for example, through
the vagina or via a mini–laparotomy incision.
Use of the LiNA Xcise requires adequate training and
experience in performing laparoscopic myomectomy and
hysterectomy.
Be careful when inserting or removing the device. Make sure
that the cutting blade is retracted by putting the trocar in the
"Safety Guard" position during insertion and removal and
whenever the cutting blade is not in active use. Insertion and
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
DO NOT REUSE STERILIZED USING TYPE BF
IRRADIATION EQUIPMENT
removal of the LiNA Xcise should always be performed under
direct visual control. Keep the rotating blade visible during the
entire morcellation procedure.
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.
Product description:
The LiNA Xcise contains a rotating cutting tube with built-in
trocar function that also serves to protect the sharp end of the
cutting tube. A grasper or a tenaculum forceps must be used to
pull the stripes of tissue through the lumen of the cutting tube.
The LiNA Xcise cutting function is controlled by the activation
button on the hand piece.
Energy source lifetime: Energy source designed to last for one
procedure only.
Instructions for use:
The surgeon should read the Instructions for use carefully
before using this device.
1. Carefully inspect the packaging for any damage prior to
use. Do NOT attempt to use the device if sterile barrier is
damaged.
2. Prior to using the trocar function of the LiNA Xcise, insert
the obturator fully into the device. Be sure that the trocar
is placed in the "Safety Guard" position. If not, place the
trocar in the "Safety Guard" position by holding in the
bracket and then turn the trocar (see illustration in picture
2).
3. The LiNA Xcise with obturator should be placed into the
abdomen using standard technique for laparoscopic trocar
placement. It is recommended to insert the LiNA Xcise
with obturator through a 12-14mm incision under direct
visualization.
4. In order to remove tissue use a 10-12 mm forceps or
similar instrument inserted through the lumen of the LiNA
Xcise and into the abdomen. To prevent injury to the
abdominal wall, the tissue to be morcellated should be
completely exposed before attempting to extract it through
the morcellator.
5. It is recommended to use a second pair of grasping
forceps to hold the tissue in place and reduce tissue
movement during morcellation.
6. Place the trocar in the required position by turning the
trocar into cutting position: "Cut 1" for peeling function or
"Cut 2" for coring function.
7. Adjust the coreguard if needed.
8. To activate the cutting blade and begin morcellating, press
the activation button on the hand piece while pulling pieces
of tissue through the cutting tube.
9. Release the activation button as soon as the stripe of
tissue is extracted from the LiNA Xcise.
10. For use with a 5 mm instrument: Mount the reducer cap
onto the back of the morcellator with a pressing and
turning motion.
11. After surgery, remove the LiNA Xcise from the abdominal
cavity. For proper disposal, turn the trocar into the "Safety
Guard" position, remove the reducer cap and insert the
obturator. The morcellator may now be safely disposed in
accordance with local governing ordinances and recycling
plans.
Reporting:
Any serious incident that has occurred in relation to the
device should be reported to the LiNA Medical ApS and the
competent regulatory authority of the country in which the
user and/or patient is established.
Country of origin: Poland
CE marking 2015.
2018-10 FV0178F
GB