LiNA MaxFlow SIV-100 Manual Del Usuario página 2

LiNA
Ref: SIV-100, SIV-105, SIP-010, SIP-005-370
Intended Use:
The LiNA MaxFlow is a suction and irrigation system with
electro surgery applications for laparoscopic surgery, single use.
Indications:
The LiNA MaxFlow is a multifunctional device. It effectively
removes blood and debris from the surgical site (suction/
irrigation) and in addition it can cut and coagulate by means of
electrosurgical current (monopolar or bipolar).
Please see separate instructions for the electro surgery applications.
Warnings:
• The LiNA MaxFlow 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 MaxFlow. 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 MaxFlow.
• Exercise caution while using the LiNA MaxFlow. Do NOT
place the tip nearby delicate tissue while at maximum
suction power.
• BE AWARE that due to the large suction channel (9mm) of
the LiNA MaxFlow, the use of maximum power can cause
kinking of the suction channel.
• BE AWARE that the probe is correctly fastened to the valve/
handle by securing the locking mechanism at the click-on
system.
• After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
Be aware of sharp edges.
Precautions:
Use of the LiNA MaxFlow requires adequate training and
experience in performing laparoscopic procedures.
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:
It consists of an ergonomic suction/irrigation valve/handle with
two push buttons (suction and irrigation) and either a 5mm or
10mm probe.
Instructions for use:
This information is provided for using the LiNA MaxFlow.
It is not intended to demonstrate laparoscopic techniques
or procedures. Consult published and recognized medical
literature for appropriate techniques, complication and
hazards prior to doing any laparoscopic procedure. Consult
the instructions for use provided by the manufacturer of the
manometer for contraindications.
The surgeon should read the Instructions for use carefully
before using this device.
LiNA Medical - 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
MaxFlow
TM
1. a. Carefully inspect the packaging for any damage prior to
use. Do NOT attempt to use the device if sterile barrier is
damaged.
b. Make sure to remove the protection cap from the tip of
the probe.
2. Prior to activating the LiNA MaxFlow make sure that the
probe has been correctly secured at the locking mechanism
at the valve/handle.
3. Make sure the spikes are connected to the bags of saline
and the funnel is connected to the collecting bottle.
4. Introduce the LiNA MaxFlow through a port. Depending on
the port size make sure to use the appropriate probe (5mm
or 10mm).
5. By pressing the front button (white) the suction will be
activated.
By pressing the back button (blue) the irrigation will be
activated.
6. The false air regulator at the valve/handle reduces the
suction power. To activate the regulator, the slider should
be adjusted to the left (when viewing the valve/handle
from the back of the product). Be aware that the product
is delivered with the false air regulator in the 'OFF' position
(when viewing the valve/handle from the back it is turned
to the right)
7. After surgery, remove the LiNA MaxFlow through the port.
For proper disposal, the LiNA MaxFlow should be disposed
in accordance with local governing ordinances and
recycling plans.
GB
2012-03 FV0069G