Packaging - Sutter Bison Bedienungsanleitung

Avoid unintentional tissue contact with live metal components of the jaw tips during
activation (FIG D)
a Gas embolism may occur during laparoscopy applications.
Disassembly (FIG C):
C1: First disconnect the cable from the instrument.
C2: Press push button (3) and simultaneously pull the shaft (2a) completely out
of the handle.
C3: Grasp the rotary knob (2b). Hold the electrode insert (7) on the front end and
turn it out of the shaft (2a).
a Do not hold the electrode insert (7) on the moveable jaw part (1).
C4: Pull the insulating tube (8) off the shaft (2a). Now the forceps are disassembled.
Reconditioning:
General information:
Observe national guidelines and regulations!
Disconnect the instrument from the cable!
The overall reconditioning process encompasses pre-cleaning, cleaning / disinfec-
tion, and sterilization.
Machine cleaning / disinfection is preferred due to effectiveness and reproducibility!
a Do not immerse in hydrogen peroxide (H
Pre-cleaning:
• Do not allow blood and tissue residues to dry up; within no more than 1 hour,
rinse thoroughly with cold water, also inside on the thread of the jaw parts and
inside the tube shaft! Use a soft brush if needed (no wire brush or similar) until
no more tissue residues are visible.
• Immerse the disassembled instrument in cold water for 5 minutes; the lumina
must be filled.
• Rinse the lumina of the instruments for at least 10 seconds with tap water, pres-
sure 3.8 bar.
• Moveable parts must be moved back and forth several times during pre-cleaning.
a Avoid excessive manual spreading of the jaw parts! Initial damage can lead to
breakage during application with repeated grasping.
Machine cleaning and disinfection:
In selecting the cleaning and disinfection device (CDD), note that the effectiveness
of the CDD must have been tested (FDA clearance for instance, or the CE marking
according to EN ISO 15883).
• Load instruments into the CDD. The lumina have to be connected to the flushing
connection of the CDD. In doing so, make sure the instruments do not touch
each other and are securely supported.
• The optionally available storage tray (701740) ensures secure support.
Program steps
Pre-rinse with cold tap water
Clean with 0.5 % (5 ml/liter)
neodisher ® MediClean forte
Neutralize with cold demineralized
water
Final rinse with cold demineralized
water
Thermal disinfection
• Please note: The preceding instructions contain validated minimum times for
successful cleaning with the prescribed program steps. If a different cleaning
agent is used, only use products with properties comparable to neodisher
MediClean forte (Dr. Weigert, Hamburg), for instance regarding the pH value
and compatibility with plastics (note the instructions for the cleaner in selecting
the process parameters). Please contact your supplier or hygiene officer in case
of questions.
Inspection:
Prior to sterilization, visually inspect the instrument and check for intact insulation,
cleanliness, and integrity.
Maintenance:
None

Packaging:

Package cleaned and disinfected instruments in disposable sterilization packaging
(single or double packaging), or wrap the instrument or tray with the cleaned and
disinfected instruments in a cotton cloth and store them together in suitable sterili-
zation containers meeting the following requirements:
• EN ISO/ANSI AAMI ISO 11607
• Suitable for steam sterilization (resistant to temperatures up to min. 141 °C,
adequate vapor permeability)
• Sufficient protection of the instruments and/or sterilization packaging against
mechanical damage
Sterilization:
Products must be cleaned and disinfected prior to sterilization.
• Steam sterilization, steam sterilizer according to EN 13060 and/or EN 285 and
validated according to EN ISO 17665
6
O )!
2 2
Parameters
2 minutes
55±2 °C, 5 minutes
3 minutes
2 minutes
Thermal disinfection according to
national requirements. An A
of 3000 can for example be obtained
with a hold time of 5 minutes at 90 °C.
value
0
®