B. Braun Aesculap Orthopaedics 011444 Instructions For Use

Aesculap Orthopaedics
Instructions for use
4
S Spinal System – Torque wrenches/Break-off bit
Gebrauchsanweisung
4
S Spinal System – Drehmomentschlüssel/Abbrechbit
Mode d'emploi
4
S Spinal System – Clés dynamométriques/Pointe de rupture
Instrucciones de manejo
4
S Spinal System – Llaves dinamométricas/Punta de rotura
Istruzioni per l'uso
4
S Spinal System – Chiavi dinamometriche/Nipplo spezzabile
Instruções de utilização
4
S Spinal System – Chaves dinamométricas/Niple quebrável
Gebruiksaanwijzing
4
S Spinal System – Momentsleutels/Afbreekbit
Návod k použití
4
S Spinal System – Momentové klíèe/Ulamovací výstupek
CE marking according to directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE en conformidad con la directriz 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
Simbolo CE, em conformeidade com a Directiva 93/42/CEE
CE-certificering conform richtlijn 93/42/EEG
CE-oznaèení podle smìrnice 93/42/ES
Technical alterations reserved
Technische Änderungen vorbehalten
Sous réserve de modifications techniques
Sujeto a modificaciones técnicas
Con riserva di modifiche tecniche
Salvo alterações técnicas
Technische wijzigingen voorbehouden
Technické zmìny vyhrazeny
Aesculap AG & Co. KG
Am Aesculap-Platz
78532 Tuttlingen
Phone +49 7461 95-0
Fax +49 7461 95-2600
www.aesculap.de
TA-Nr. 011444 06/05 Änd.-Nr. 29070
4
S Spinal System – Torque
wrenches/Break-off bit
Symbols on product
Symbol Explanation
Attention, see instructions for use
Intended use
4
The S Spinal System – torque wrenches are used to tighten the S
System – clamping screws with a defined torque:
• 10 Nm for tightening the clamping screw in the screw head/hook head
(torque wrench FW168R for break-off bit)
• 4 Nm for tightening the clamping screw in the transverse connector
(torque wrench FW207R)
Safe handling and preparation
Caution
Federal law restricts this device to sale by or on order of a physician!
!
Read and follow the instructions for use and keep them in a safe place.
!
Read and follow the O.R. manual and keep it in a safe place.
!
Use the product only in accordance with its intended use, see Intended
use.
!
Clean the new product either manually or mechanically prior to the
initial sterilization.
!
Store any new or unused products in a dry, clean and safe place.
!
Inspect the product after each cleaning and disinfecting cycle to be sure
it is clean, functioning properly, not damaged, has intact insulation and
does not have any loose, bent, broken, cracked, worn, or fractured
components.
!
Do not use the product if it is damaged or defective. Set aside the
product if it is damaged.
!
Replace any damaged components immediately with original spare
parts.
!
Prior to each use, inspect the product for: loose, bent, broken, cracked,
worn, or fractured components.
Safe operation
The torque wrenches FW168R for break-off bit and FW207R display torque
when measuring.
!
Before using the torque wrenches FW168R for break-off bit and FW207R
check that the arrows point at the zero mark.
!
To avoid reading errors, always read off the torque display in parallel.
Risk of damage to the implant by overwinding of the
clamping screw!
!
Slowly tighten the clamping screw using the torque
wrench FW168R for break-off bit, until the arrow
CAUTION
points at 10 Nm.
Risk of damage to the torque wrench FW168R for break-
off bit due to improper usage!
!
To undo a tightened clamping screw always use screw
driver FW193R.
CAUTION
Damage to the countering instrument due to improper us-
age!
!
Always slide the countering instrument over the screw
head onto the rod as far as it will go. In doing so, make
CAUTION
sure that the rod entirely engages into the slot at the
working tip.
!
Make sure that the rod protrudes on both sides of the
countering instrument.
Risk of injury/correction loss due to improper mounting of
the clamping screw!
!
Set the clamping screw in place correctly.
!
Make certain that rods are correctly positioned on the
WARNING
floor of the groove.
!
When tightening the clamping screw always apply
counter-pressure using the countering instrument
intended for this purpose.
!
Break off the flanks only when the clamping screw has
been fully tightened.
Risk of injury due to improper mounting of the transverse
connector!
!
When tightening the clamping screw make sure that
the transverse connector completely bears on the rods.
WARNING
!
Fully tighten the clamping screw at the transverse
connector using the torque wrench FW207R (4 Nm).
!
Tighten the clamping screws, turning the torque wrench evenly in a
clockwise direction.
In doing so, make sure that the torque wrench is turned without jerk.
The break-off bit protects the implant from excessive forces if the torque
wrench FW168R is overturned.
!
If the break-off bit breaks due to excessive forces, undo the defective
break-off bit and send it in for repair.
!
Always screw on the break-off bit in such a way that the union nut of
the break-off bit and the shaft of the torque wrench fit closely.
Care and handling
Note
For patients with Creutzfeldt-Jakob Disease (CJD), suspected CJD or possible
variants of CJD, observe the relevant national regulations concerning the
reprocessing of the products.
After each use
Damage to the implant due to improper cleaning of the
torque wrench FW168R for break-off bit!
!
Always disassemble the break-off bit for cleaning and
sterilization of the torque wrench.
CAUTION
!
Reprocess the contaminated product as soon as possible.
!
For mechanical cleaning and disinfecting, place products in a suitable
wire basket (avoid watermarks).
!
Process the product preferably when dry.
!
If it is processed while wet, use an active cleaning disinfectant. Prior to
mechanical cleaning and disinfecting, rinse the product thoroughly in
clear running water.
!
Do not use high-grade chlorine bleaching, as it might provoke pitting
corrosion.
!
Carry out ultrasound treatment, if required, according to the user
instructions provided by the manufacturer of the ultrasound equipment:
– as an effective mechanical supplement to manual cleaning.
– for pre-cleaning of products with dried debris prior to mechanical
cleaning.
– for subsequent cleaning of products that still have dried debris on
them after mechanical cleaning.
!
Follow the manufacturer's instructions.
Manual cleaning, disinfecting
!
Place the product in a suitable active cleaning disinfectant in such a way
that all surfaces, interior surfaces, lumen, and openings are covered.
Follow the disinfectant manufacturer's instructions.
!
After disinfecting chemically, rinse the product thoroughly in plenty of
clear running water. Follow the disinfectant manufacturer's instructions.
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Remove encrusted materials with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
!
Clean lumen and channels with a soft round nylon brush of the
appropriate diameter.
!
Carry out the final rinse in distilled or fully demineralized water.
!
Dry the product with an absorbent and lint-free cloth.
!
Dry lumen and channels with compressed air.
Mechanical cleaning, disinfecting
!
Reprocess the products using cleaning-optimized cycles. Follow the
instructions provided by the manufacturer of the device.
!
Carry out the final rinse in distilled or fully demineralized water.
!
Be sure the drying phase is sufficiently long.
!
Remove the product from the machine immediately after the cycle ends.
Control
!
Allow the product to cool down to room temperature.
!
Spray moving parts (such as hinges and latches) as well as the break-off
bit with a sterilizable and moisture-permeable lightweight maintenance
oil such as Aesculap Sterilit Spray JG 600 or maintenance oil JG 598).
!
Inspect the product after each cleaning and disinfecting cycle to be sure
it is clean, functioning properly, not damaged, has intact insulation and
does not have any loose, bent, broken, cracked, worn, or fractured
components.
!
Set aside the product if it is damaged.
Storage
!
Store the product in suitable storage aids.
Sterilization method and parameters
4 !
Spinal
Sterilize with steam, taking note of the following:
The sterilization has to be done according to a validated steam
sterilization procedure (e.g. in a sterilizer according to EN 285/ANSI/
AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and validated according
to EN 554/ISO 13683). In case of application of the fractionated vacuum
procedure the sterilization has to be carried out for a minimum of
5 minutes at 134 °C and at 2 bar pressure.
Chemical residues which are not fully eliminated might cause staining.
!
Be sure the drying phase is sufficiently long to avoid excessive moisture
and resulting watermarks on the product.
Sterilization for the US market
• Sterilization of the device may be accomplished by steam.
• Aesculap does not recommend the device be sterilized by "Flash" or
chemical sterilization.
• Surgical instruments may also be placed within an Aesculap rigid
sterilization container (sterile container) for processing under generally
accepted hospital in-use conditions.
The recommended sterilization parameters are as follows:
Sterilization
Temp.
method
Pre-vacuum 270–275 °F
Warning for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-
Jakob Disease (CJD), the device cannot be reused and must be destroyed due to
the inability to reprocess or sterilize to eliminate the risk of cross-
contamination!
Maintenance
The torque wrenches are calibrated by the manufacturer to 10 Nm or 4 Nm, re-
spectively.
If the arrow does not point at the zero mark with the torque wrench un-
stressed, it is damaged and must not be used in no account.
!
Replace the damaged torque wrench.
Repairs
Service work, repairs or modifications to the product must be carried out by per-
sonnel authorized by Aesculap only. Only in this way will warranties and guar-
antees remain valid.
!
If any repairs are needed, please send the product to:
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95 27 00
Fax: +49 7461 16 28 87
E-mail: ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042
Aesculap Repair Hotline
Phone: +1 800 214-3392
Fax: +1 314 895-4420
Other service addresses can be obtained from the address indicated above.
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
4
S Spinal System – Drehmoment-
schlüssel/Abbrechbit
Symbole am Produkt
Symbol Erklärung
Gebrauchsanweisung beachten
Einsatzgebiet
4
Die S Spinal System – Drehmomentschlüssel dienen zur Fixierung der S
nal System – Klemmschrauben mit definiertem Drehmoment:
• 10 Nm zum Anziehen der Klemmschraube im Schraubenkopf/Hakenkopf
(Drehmomentschlüssel FW168R für Abbrechbit)
• 4 Nm zum Anziehen der Klemmschraube im Querverbinder (Drehmo-
mentschlüssel FW207R)
Sichere Handhabung und Bereitstellung
!
Gebrauchsanweisung lesen, beachten und aufbewahren.
!
OP-Manual lesen, beachten und aufbewahren.
!
Produkt nur bestimmungsgemäß verwenden, siehe Einsatzgebiet.
!
Fabrikneues Produkt vor der ersten Sterilisation gründlich reinigen
(manuell oder maschinell).
!
Fabrikneues oder unbenutztes Produkt an einem trockenen, sauberen
und geschützten Platz aufbewahren.
!
Produkt nach jeder Reinigung und Desinfektion prüfen auf: Sauberkeit,
Funktion und Beschädigungen, z. B. Isolation, lose, verbogene, zerbro-
chene, rissige, abgenutzte und abgebrochene Teile.
!
Kein beschädigtes oder defektes Produkt verwenden. Beschädigtes
Produkt sofort aussortieren.
!
Beschädigte Einzelteile sofort durch Originalersatzteile ersetzen.
!
Produkt vor jeder Verwendung visuell prüfen auf: lose, verbogene,
zerbrochene, rissige, abgenutzte und abgebrochene Teile.
Bedienung
Die Drehmomentschlüssel FW168R für Abbrechbit und FW207R messen an-
zeigend.
!
Vor dem Verwenden der Drehmomentschlüssel FW168R für Abbrechbit
und FW207R prüfen, ob die Anzeigepfeile auf Null stehen.
!
Um Ablesefehler zu vermeiden, Anzeige immer parallel ablesen.
Beschädigung des Implantats durch Überdrehen der
Klemmschraube!
!
Klemmschraube mit Drehmomentschlüssel FW168R
für Abbrechbit langsam anziehen, bis der Anzeigepfeil
VORSICHT
auf 10 Nm steht.
Beschädigung des Drehmomentschlüssels FW168R für Ab-
brechbit durch unsachgemäße Verwendung!
!
Zum Lösen der festgezogenen Klemmschraube Schrau-
bendreher FW193R verwenden.
VORSICHT
Beschädigung des Gegenhalteinstruments durch unsachge-
mäße Verwendung!
!
Gegenhalteinstrument immer bis zum Anschlag auf
den Stab über den Schraubenkopf schieben. Dabei dar-
VORSICHT
auf achten, dass sich der Stab vollständig innerhalb des
Schlitzes am Arbeitsende befindet.
!
Sicherstellen, dass der Stab auf beiden Seiten des Ge-
genhalteinstruments übersteht.
Minimum exposure time
In a sterile
Wrapped
container system
4 min 4 min
4
Spi-