Braun AESCULAP miaspasTL User manual

Gebrauchsanweisung
miaspasTL-Rongeure
Instructions for use
miaspasTL rongeur
Mode d’emploi
Rongeurs miaspasTL
Instrucciones de manejo
Pinzas de agarre miaspasTL
Istruzioni per l’uso
Rongeure miaspasTL
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5
3
6 5
3
6 5
3
4
1 2
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Legend
1Pins
2Grooves
3Handle
4Mark
5Collar
6Shaft
Applications
miaspas TL rongeurs are intended for use in endoscopic
surgery on the vertebral column and the thoracic spine
(thoracoscopic, without gas insufflation), as well as on
the lumbar vertebral column (laparoscopic, with gas
insufflation).
miaspasTLrongeurs are used to grasp and remove
invertebral disc tissue.
Safe handling and preparation
ÀPrior to each use of the rongeur, check to ensure
that it is assembled and functioning properly (see
Disassembling), and that none of its components
are defective or damaged.
ÀDo not use damaged or defective instruments or
instruments components.
ÀThe patient must be fully informed with regard to
the possible risks and benefits of endoscopic
surgery on the vertebral column.
A prerequisite for the use of rongeurs is detailed
knowledge of vertebral surgery and the biomechanics
of the vertebrae.
The rongeurs for endoscopic vertebral surgery can be
used in conjunction with the AESCULAP-PROMIS-LINE
of trocars.
ÀBe sure that the rongeurs have been cleaned,
disinfected and sterilized prior to the operation (see
Cleaning, disinfecting, sterilization).
For further information, please contact:
AESCULAP AG & Co KG
ORTHOPÄDIE DIVISION
Am Aesculap-Platz
D-78532 Tuttlingen
Tel.: [phone]
Fax.: [phone]
Disassembling/Assembly of the rongeurs
Note
In order to avoid damaging the rongeur, do not use any
tools during disassembling or assembly.
Disassembling
ÀLoosen the collar 5.
ÀPull out the shaft 6.
Assembly
ÀPut the shaft 6in place pushing the grooves 2over
the pins 1.
Rotate shaft 6at a 90° angle until the pins 1lock
in place in the grooves 2.
ÀTighten the collar 5.
Rotating the shaft 6when the instrument is
assembled:
ÀLoosen the collar 5until the mark 4is visible.
ÀPull on the shaft 6, away from the collar 5, and
rotate the shaft to the desired position.
ÀLock the shaft 6in place over the pins 1in the
grooves 2.
ÀTighten the collar 5.
Cleaning, disinfecting, sterilization
After each use
ÀClean the contaminated instrument as soon as
possible.
ÀDisassemble the instruments (see Disassembling).
ÀRemove debris from the instrument while they are
dry.
ÀIf the instrument is cleaned while wet, use an
active cleaning disinfectant. Prior to mechanical
cleaning and disinfecting, rinse the instrument
thoroughly in clear running water.
WARNING
Damage or destruction of rongeurs!
ÀUse rongeurs only for removing
invertebral disc tissue.
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ÀIf ultrasound is needed, carry out the procedure
according to the user instructions provided by the
manufacturer of the device:
– as an effective mechanical supplement to
manual cleaning.
– for initial cleaning of instruments with dried
debris on them prior to mechanical cleaning.
ÀPerform manual or mechanical cleaning. Follow the
manufacturer's instructions.
Manual cleaning and disinfecting
ÀPlace the instrument in a suitable active cleaning
and disinfectant solution in such a way that all
surfaces, interior surfaces, lumina, and openings
are covered. Follow the disinfectant manufacturer's
instructions.
ÀAfter disinfecting chemically, always rinse the
items thoroughly in plenty of clear running water.
Follow the disinfectant manufacturer's
instructions.
ÀRemove encrusted material with a soft nylon brush.
Do not use harsh cleaning agents or metal brushes.
ÀDry lumina and irrigation channels with a soft
round nylon brush of the appropriate diameter.
Note
Brushes should be an appropriate diameter for the
lumina they are being used to clean.
ÀCarry out the final rinse in distilled or fully
demineralized water.
ÀDry the instruments with a soft, absorbent, lint-free
cloth.
ÀDry lumina and channels with compressed air.
Mechanical cleaning and disinfecting
ÀClean and disinfect only in an appropriate cleaning
and disinfecting apparatus, using an appropriate
cleaning and disinfecting procedure.
ÀPlace components with lumina and channels on
special washing machine attachments.
ÀCarry out the final rinse in distilled or fully
demineralized water.
ÀBe sure the drying phase is sufficiently long.
ÀRemove the instrument from the apparatus as soon
as the program is completed.
Care, checking
ÀAllow the instrument to cool down to room
temperature.
ÀMoving parts such as hinges and latches should be
sprayed with a sterilizable and moisture-permeable
lightweight machine oil such as AESCULAP STERILIT
Spray JG 600 or maintenance oil JG 598).
ÀAssemble the separable instrument (see Assembly).
ÀInspect the instrument after each cleaning and
disinfecting cycle to be sure it: is clean, is
functioning properly, is not damaged, has intact
insulation and does not have any loose, bent,
broken, cracked, worn, or fractured components.
ÀSet aside and replace the instrument if it is
damaged and defective.
Packing
ÀKeep the instrument in appropriate storage units
(e.g. AESCULAP storage rack for MIC instruments
and trocars).
Sterilization
ÀSterilize with steam, taking note of the following:
Carry out sterilization in accordance with a
validated steam sterilization process (e.g. in a
sterilizer in conformance with EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST46-1993, and
validated in conformance with EN 554/ISO 13683.
Pre-vacuum sterilization should be carried out for a
minimum of 5 minutes at 134 °C/2 bar pressure.
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Repairs
Repairs may be carried out only by persons authorized
to do so by AESCULAP. Only in this way will warrantees
and guarantees remain valid.
ÀIf any repairs are needed, please send the device to:
AESCULAP TECHNISCHER SERVICE
Stockacher Str. 134
D-78532 Tuttlingen
Tel.: [phone]
Fax: [phone]
or in the US:
AESCULAP Inc.
1000 Gateway Boulevard
South San Francisco
CA 94080-7030
AESCULAP Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the ad-
dress indicated above or from serviceaddress@aescu-
lap.de.
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