English - Sutter Bison Bedienungsanleitung

2 ENGLISH

Components (FIG A):
1 (Movable) jaws
2a Shaft
2b Rotary knob with 360 degree rotation
3 Push button
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
and disposed of by trained medical staff!
These instructions do not substitute the
instructions for the electrosurgical unit and
other accessories used.
Intended use:
Bipolar clamp for grasping, coagulating and
cutting of soft tissue in minimally invasive
surgery.
Prior to use:
Assembly (FIG B)
B1: Slide insulation tube 8 on shaft 2a.
B2: Push electrode insert 7 gently as far as it
will go into shaft 2a.
B3: Hold rotary knob 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 7.
B4: 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
easily be manoeuvred into it.
Leave the movable handle piece in posterior
position, do not hold it.
Introduce shaft 2a including the electrode
insert 7 straight into the handle. The handle
now returns to its home position and push
button 3 locks into place.
Rotary knob 2b will now rotate around 360
degrees, and the jaws 1 open and close easily
when the handle is squeezed.
Connect the instrument properly only to the
bipolar outlet of the electrosurgical unit used.
Connect the instrument with its cable only
to an electrosurgical unit that has been
switched off or is in standby mode.
Disregarding these instructions may lead
to burns and electrical shock.
Examine the integrity of the insulation and the
entire instrument as well as the completeness,
cleanness and functionality of the product.
B5: Before using the instrument, perform a
short function test:
Adjust the electrosurgical unit to medium
power or 30 – 40 watts, place three layers of
wet gauze between the jaws, and activate the
unit. When functioning properly, steam will
evaporate after 2 – 3 sec.
Do not touch the jaws. They may store
heat.
Only use complete, functional, safe and
sterilized products!
During use:
Only activate current with tissue grasped
between the jaws of the instrument!
Always use the lowest power setting available
to achieve the desired surgical effect.
Max. voltage: 1000Vp.
The jaws may cause injuries!
The jaws may store heat after use and
cause burns!
Never place the instrument on or close to
the patient!
Do not use near inflammable or explosive
substances!
The uninsulated parts of the working end
of the instrument may carry electricity and
cause injuries!
If needed, clean jaws with sterile solution
(Aquadest) and dry. Do not use saline solution!
When using together with irrigation instru-
ments, prefer an irrigation solution that is not
electro-conductive.
Undesired activation or movement of
laparoscopic electrodes outside the
surgeon's field of vision may lead to
undesired tissue damage.
Gas embolisms may occur in laparoscopic
surgery.
(United States:) Not intended for female
sterilization.
Disassembly (FIG C):
C1: Disconnect the instrument from the cable.
C2: Press push button 3 and pull shaft 2a
simultaneously out of the handle.
C3: Hold rotary knob 2b, take the electrode
insert 7 at its front end and unscrew it from
shaft 2a.
Do not hold the (movable) jaws 1 of the
electrode insert.
C4: Pull the insulating tube 8 from shaft 2a.
The clamp has now been disassembled.
Cleaning and sterilization:
Clean the instrument including the thread of
the tip thoroughly immediately after use.
Do not allow blood and debris to dry on the
instrument.
Manual Pre-cleaning:
Use a soft cloth or brush to remove blood and
debris.
Use a cleaning brush (TAB A1) to clean the
jaws.
Rinse instrument including inner lumen
thoroughly with clean tap water after cleaning.
Manual pre-cleaning of the lumen: > 15 sec
with water, 3 bars pressure.
=> Do not use aggressive/abrasive cleaners.
Electrode inserts must be cleaned in ultra-
sound: 40°C (104°F), 15 min. with alkaline
cleaner.
Machine cleaning/desinfection:
Use an approved cleaning programme: 70°C
(158°F), > 7 min. with cleaner; neutralize
5 min., rinse.
We recommend 0.5% concentrated alkaline
cleaner.
No residue may remain.
=> Perform visual control prior to sterilization
and verify the integrity of the insulation as
well as cleanness and integrity of the entire
instrument.
Only sterilize clean/disinfected instruments.
Use paper/foil wrapping or appropriate sterili-
zation containers.
Sterilization in the autoclave (fractioned
pre-vacuum):
Temperature 134°C (273°F), 5 min.;
max. 135°C (275°F), 18 min.
=> Sterilization at high temperatures and long
sterilization times shorten the life cycle of the
instrument.
Do not sterilize in hot air.
Do not sterilize in STERRAD ® .
=> A certain discolouring of the tips of
SILVERGlide ® forceps is normal and may easily
be removed with a polishing cloth (TAB A2).
For returns only sterilized instruments will be
accepted.
Sutter cannot be held liable for changes to
the product after purchase or deviations
from these instructions.
Information on applicable standards, regula-
tions and existing validations may be obtained
from the manufacturer.
Subject to change.
STERRAD ® is a trademark of Johnson &
Johnson, Inc.
SILVERGlide ® is a trademark of Silverglide
Surgical Technologies, Inc.
FIG A (Components)
FIG B (Assembly and function test)
FIG C (Disassembly)