Orthofix TrueLok Gebrauchsanleitung

PQ TLS
ORTHOFIX Srl
Via Delle Nazioni 9 - 37012 Bussolengo (Verona) - Italy
Telephone 0039-0456719000 - Fax 0039-0456719380
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EN
External fixation system
Consult instructions for Use
Important information for the
Read instructions before use
INFORMATION TO USE TrueLok SCREWS (HALF PINS)
TrueLok HALF PINS SHOULD BE USED ONLY WITH THE
TrueLok SYSTEM FOR SPECIFIC INFORMATION ON THE
TrueLok SYSTEM REFER TO PQ TLK.
It is essential that special care be taken to ensure that
the screws do not penetrate joints or growth cartilage
in pediatric patients. The length of both the entire screw
and the threaded section must be selected in accordance
with the dimensions of the bone and soft tissues.
Screws should always and only be inserted using a
driver or T-wrench, regardless of whether or not pre-
drilling has been performed. It is important to apply
moderate force to penetrate the first cortex. Diaphyseal
bone screws should always be inserted in the centre of
the bone axis, in order to avoid weakening. In all cases,
the surgeon should be mindful of the amount of torque
required to insert the screw. Should this appear more
difficult than usual, it is recommended the screw be
removed and cleaned and the bone drilled once more
using the drill bit, even if this has already been used.
Excessive penetration of the second cortex must be
avoided because this may cause soft tissue damage.
Bone screws must never be inserted so far that the
smooth shaft penetrates the first cortex, in order to
avoid the risk of bone damage.
The diameter of the screw must be selected in
accordance with the diameter of the bone: for a bone
diameter greater than 20 mm, 6.0 mm, 6.0 - 5.0 or 6.0
- 5.6 mm should be used; for a bone diameter of
between 15 and 20 mm, 5.0 mm screws should be
used and for a bone diameter between 10 mm and 15
mm, 4.0 mm bone screws are recommended.
Self-drilling screws with a thread diameter of 5.0 mm or
more must never be inserted with a power tool, and
should be inserted manually or with the use of a hand
drill. Self-drilling screws with a smaller thread diameter
may be inserted either manually or with the use of a
low-speed electric drill.
TrueLok screws are not tapered and have a thread that
has the same diameter throughout.
TrueLok screws are available in 4, 5, and 6mm
diameters, each having a total length of 180mm and a
thread length of 55mm. If the screw has to be inserted
in areas wider than 50mm, XCaliber bone screws
should be used. TrueLok screws are
self-drilling, self-tapping, and have a standard quick
connect end for ease of use in the operating room.
The following steps outline the recommended method
of screw insertion and fixation:
1. A half pin fixation bolt is inserted into an
appropriate hole of the ring.
The half pin fixation bolt acts as a guide for half
pin insertion
2. A K-wire is passed through the hole of the
fixation bolt along the intended direction of the
half pin insertion. Make a stab incision in the
skin at this level
3. Use scissors or hemostats to make a track
through the soft tissues to the bone with blunt
dissection only.
4. The desired half pin is inserted through the
fixation bolt and soft tissue track, and drilled into
the first bony cortex. Insertion through the second
cortex should be done manually using the
dedicated Orthofix T-wrench.
5. The half pin fixation bolt is then secured firmly
to the external support with a nut.
If TrueLok screws are cut to length, screw covers should
be used to protect the cut end. TrueLok screws which
have been cut to length could be removed manually
with the Universal Chuck with
T-Handle (17955) or with a power drill.
Care should be taken of the soft tissues during screw or
wire insertion.
All Orthofix internal and external fixation products should be used together
with their corresponding Orthofix implants, components and accessories.
Their application should be performed with the specific Orthofix
instrumentation, following carefully the surgical technique recommended by
the manufacturer in the appropriate Operative Technique Manual.
SYMBOL
NON STERILE
0123
IT
Sistema di Fissazione
Consultare le istruzioni per l'uso
Informazioni importanti per il
chirurgo che effettuerà
Leggere le istruzioni prima
INFORMAZIONI SULL'UTILIZZO DELLE VITI TrueLok
(VITI OSSEE)
SI CONSIGLIA DI UTILIZZARE LE VITI OSSEE TrueLok SOLO
CON IL SISTEMA TrueLok.
PER INFORMAZIONI SPECIFICHE SUL SISTEMA TrueLok
FARE RIFERIMENTO A PQ TLK.
È necessario prestare particolare attenzione durante
l'inserimento delle viti a non danneggiare le giunture o
la cartilagine epifisaria nei pazienti pediatrici. Scegliere
la lunghezza della vite intera e della sezione filettata in
base alle dimensioni dell'osso e dei tessuti molli.
Le viti devono sempre essere inserite tramite un
cacciavite o una chiave a T, indipendentemente
dall'utilizzo di un perforatore. È importante applicare
una forza moderata durante la penetrazione della prima
corticale. Le viti ossee diafisarie devono essere sempre
inserite al centro dell'asse osseo onde evitare di causare
indebolimento. In tutti i casi, il chirurgo deve essere
consapevole della quantità di giri necessari per inserire
la vite. Se il procedimento risulta più complicato del
solito, si consiglia di rimuovere e pulire la vite, quindi
di perforare nuovamente l'osso utilizzando la punta
perforatore anche se è già stata utilizzata.
Evitare un'eccessiva penetrazione della seconda
corticale poiché potrebbe causare un danneggiamento
dei tessuti molli. Durante l'inserimento, il corpo liscio
della vite ossea non deve mai penetrare la prima
corticale, onde evitare il rischio di danneggiare l'osso.
Selezionare il diametro della vite in base al diametro
dell'osso. Se l'osso ha un diametro superiore a 20 mm,
scegliere una vite con diametro di 6,0 mm, 6,0 - 5,0 mm
o 6,0 - 5,6 mm. Se il diametro dell'osso è compreso tra
D 01/16
Instruction leaflet - Please
read prior to use
TrueLok
TrueLok Screws
RX Only
surgeon performing
the operation
Consult instructions for Use
Single use. Do not reuse
Sterilised with ethylene oxide
Sterilised by irradiaton
NON STERILE / NON STERILE
Catalogue number / Lot number
Expiry date (year-month)
CE marking in conformity to MDD 93/42/ECC
as amended by 2007/47/EC
Date of manufacture / Manufacturer
Do not use if package is opened or damaged
Foglietto illustrativo
Leggere attentamente
prima dell'uso
TrueLok
Esterna
Viti TrueLok
Solo per RX
l'operazione
dell'uso