Sutter Bison Anweisung Seite 4

ENGLISH
Components (FIG A):
1 Movable jaws
2a Shaft
2b Rotary wheel with 360 degree rotation
3 Pushbutton
4 Connector
5 Movable part of handle
6 Rigid part of handle
7 Electrode insert (incl. jaws)
8 Insulation tube
Non-sterile. – Clean and sterilize before first
and subsequent uses.
Electrosurgical accessories may only be used
by trained medical staff.
These instructions do not substitute the in-
structions for the electrosurgical unit and
other accessories used.
Intended use:
Bipolar clamp designed for grasping, coagu-
lating and cutting of soft tissue during mini-
mally invasive procedures.
Prior to use:
Assembling the product (FIG B)
-Slide the insulation tube 8 on shaft 2a.
-Push electrode insert 7 gently as far as it will
go into shaft 2a.
- Hold rotary wheel 2b and secure electrode
insert 7 by about six turns as far as it can be
turned. The thread must run smoothly and not
grate or get caught.
Do not hold by the (movable) jaws 1 of
the electrode insert.
-Close jaws: If necessary, hold closed with
fingertips. Press push button 3 to facilitate
the insertion of the shaft.
Hold handle as shown in the illustration so
that the movable part of the handle 5 will fall
into posterior position or can be easily ma-
neuvered into it.
Leave the movable part of the handle 5 in po-
sterior position; do not hold it.
Slide shaft 2a, including the electrode insert,
straight into the handle. The handle now re-
turns to its home position and the pushbutton
locks into place.
The product is correctly mounted when rotary
wheel 2b can be turned 360 degrees and the
jaws 1 can be opened and closed without dif-
ficulty using the handle.
Connect the instrument properly only to the
bipolar outlet of the electrosurgical unit used.
Connect the product only to an electro-
surgical unit that has been turned off or is in
standby mode. Disregarding these instructi-
ons may lead to burns and electrical shock!
Examine the integrity of the insulation and the
entire instrument as well as its completeness,
cleanness, and proper function.
Generally the life cycle of the electrode insert
depends on the treatment and applications it
gets, and may reach up to max. 20 uses.
Before using the instrument, perform a short
function test:
Adjust the electrosurgical unit to medium
power or 30 to 40 watts. Place three layers
of soft gauze between the jaws and activate
the unit. When functioning properly, some
steam will evaporate after 2 to 3 secs.
Do not touch the jaws. They may be hot
after activation.
Only use fully mounted, functional, safe
and sterilized products!
During use:
Always use the lowest power setting availa-
ble to achieve the desired surgical effect.
Max. voltage: 2000 Vpp.
Max. power settings
Erbe VIO:
MODE BIPOLAR CUT, effect 4, max. 100 watts
MODE BIPOLAR SOFT COAG, effect 5, max.
120 watts.
Avoid spark formation around the jaws when
working with other generators.
The jaws may cause injuries.
The jaws may be hot after use and cause
burns!
Never place instrument on or close to pa-
tient.
Do not use near inflammable or explosive
substances.
The uninsulated parts of the working end
of the instrument may carry electric current
and cause injuries.
If needed, clean jaws with sterile solution
(Aquadest) and dry. Do not use saline solu-
tion!
When using together with irrigation instru-
ments, prefer an irrigation solution that is not
electroconductive.
Undesired activation or movement of la-
paroscopic electrodes outside the surge-
on's field of vision may lead to undesired tis-
sue damage.
Avoid unintended activation of the live
metal parts of the jaws during activation
(FIG D)
Gas embolisms may occur in laparosco-
pic surgery.
Disassembly (FIG C):
C1: Disconnect the instrument from the
cable.
C2: Press pushbutton 3 and pull shaft 2a si-
multaneously out of the handle.
C3: Hold rotary wheel 2b with one hand and
the electrode insert 7 at its front end with the
other hand. Screw the electrode out of shaft
2a.
Do not hold the movable jaws of the elec-
trode insert.
C4: Pull the insulation tube 8 from shaft 2a.
The instrument has now been disassemb-
led.
Reprocessing
Clean instrument thoroughly and immediately
(no later than 60 minutes) after use. Also
clean the thread inside the jaws and the in-
side of the shaft tube.
Do not allow blood and debris to dry on the
instrument!
Manual pre -cleaning:
Disassemble instrument.
Use a soft cloth or brush to remove blood and
debris.
Use a cleaning brush to clean the jaws.
=> Do not use aggressive / abrasive clea-
ners.
Rinse instrument thoroughly after cleaning.
Manual pre-cleaning of the lumen > 15 secs,
3 bars pressure.
General recommendation for the following
cleaning steps:
Only use alkaline or mild alkaline cleaner
compatible with synthetics, borer deconex 28
ALKA ONE-x.
The instrument and its parts must be cleaned
in an ultrasonic bath: alkaline cleaner, 15
min., 40 °C (104 °F).
Machine cleaning/disinfection:
Choose a washer/disinfector that has been
tested in accordance with the current stan-
dards (DIN EN ISO 15883).
Procedure:
➜ 4 min. pre-cleaning in cold water
➜ 6 min. with detergent (0.5% deconex 28
alka one-x) at 70°C (158 °F)
➜ 3 min. neutralization in warm water
>40°C (104 °F)
➜ 2 min. rinsing with warm water >40°C
(104 °F).
No residue may remain.
We recommend the use of the Sutter storage
tray (70 17 40) to avoid damage of the shaft
tube and electrode insert in the reprocessing
treatment.
=> Perform visual control prior to sterilization
and verify the integrity of the insulation as
well as the cleanness and integrity of the en-
tire instrument. Disassemble and sterilize in-
strument in paper/foil wrapping
appropriate sterilization containers.
Sterilization in the autoclave (fractioned pre-
vacuum):
Use a steam sterilizer and sterilization proce-
dures that have been tested in accordance
with the current standards (DIN EN 13060,
DIN EN 285, DIN EN ISO 17665):
Temperature 134°C (273 °F), 5 min; max.
135°C (275 °F), 18 min.
Drying 10 min.
=> Sterilization at high temperatures and
long sterilization times shorten the life cycle
of the instrument.
Do not sterilize electrode inserts in STER-
RAD ® !
For returns, only sterilized instruments will be
accepted.
Sutter Medizintechnik GmbH cannot be
held liable for changes to the product after
purchase and for deviations from these in-
structions.
Information about applicable standards, re-
gulations, and existing validations may be ob-
tained from the manufacturer.
Subject to change.
STERRAD ® is a trademark of Johnson &
Johnson, Inc.
FIG A (Components)
FIG B (Assembly and function test)
FIG C (Disassembly)
FIG D (Warnings)
or