DePuy Synthes Vacu-Mix Plus Folleto De Instrucciones página 7

8. The handle is manipulated by moving it fully up and
down combined with a turning motion. This operation
generates a 'corkscrew' action which should be
repeated 30 times.
9. The handle is lowered fully and mixing continued with
a rotating motion for 30 revolutions.
10. The vacuum generator is switched off and the
vacuum connector is removed.
11. The mixing cap is unscrewed, is raised from the
syringe, and the scraper is clipped over the paddle
immediately above the blades. The paddle is then
withdrawn from the syringe with the scraper held in
place so that adhering bone cement is retained in the
syringe, thus cleaning the paddle of bone cement.
12. The extrusion nozzle is applied to the syringe.
13. The syringe is then loaded into the gun and the
cement is extruded: please refer to instructions
supplied with the CMW Cement Gun - Mark III.
IMPORTANT NOTE: THE ECONOMISER DRIVE ROD
SHOULD ONLY BE ADVANCED USING THE TRIGGER.
NEVER USE FORCE ON THE ECONOMISER DRIVE ROD.
Application
Prior to cement application, it is recommended that a
cement restrictor is always used during cementation of
the femur and that this is introduced at the required depth
in the prepared bone cavity. After mixing the cement
thoroughly and once a dough is formed in the syringe,
the surgeon should wait until the cement no longer
adheres to the glove. It is vital that premature insertion
of cement is avoided as this may lead to a drop in the
patient's blood pressure. To avoid this, the appearance
of the cement should be observed to ensure the surface
has become dull as opposed to shiny.
Introduction of bone cement should be carried out in a
retrograde fashion. Once the cavity is filled, it is strongly
advised that adequate pressurisation is applied and
maintained up to the point of hardening. Implant insertion
should be carried out at a time appropriate for the bone/
joint and prosthesis design concerned. In general,
implant insertion should be delayed until the cement
has developed a sufficient degree of viscosity to resist
excessive displacement by the implant. However, the
implant insertion should not be delayed such that there
is a risk that the procedure cannot be completed due to
cement hardening.
Following introduction the implant must be firmly held
in position to avoid movement and pressurisation must
be maintained until the cement finally hardens. Excess
bone cement must be removed before the cement has
completely hardened.
The handling characteristics and setting times of
the cement are affected by ambient temperature.
Please refer to the end of the instruction leaflet
for guidance charts (Note: the usage charts were
generated under controlled laboratory conditions).
The charts provide information that is important to
the successful outcome of the surgical procedure if
the bone cement is to be used at a temperature other
than that recommended (73°F (23°C)).
DISPOSAL
Prior to disposal, surplus bone cement should be allowed
to set. It should then be disposed of as clinical waste.
LIMITS OF USEFULNESS
Store below 77°F (25°C) and protect from light.
•
Store at the recommended mixing temperature of
•
73°F (23°C) for a minimum of 24 hours before use.
Sterility is only guaranteed if the packaging is unopened
•
or undamaged.
• Vacu-Mix Plus pre-packed with DePuy CMW 1
Gentamicin and Vacu-Mix Plus pre-packed with
DePuy CMW 3 Gentamicin bone cements are for
single use only, do not re-use.
• Resterilisation of any of the components must not be
attempted.
Further information on the use of Vacu-Mix Plus pre-
packed with DePuy CMW 1 Gentamicin and DePuy
CMW 3 Gentamicin bone cements can be obtained
from the manufacturer.
DATE OF PREPARATION: June 2017
VACUMIX PLUS MIT DEPUY CMW 1
GENTAMICIN KNOCHENZEMENT VORGEPACKT
VACUMIX PLUS MIT DEPUY CMW 3
GENTAMICIN KNOCHENZEMENT VORGEPACKT
PRODUKTINFORMATION
ZUR SPEZIELLEN BEACHTUNG DURCH DEN
OPERATEUR
GERÄTEBESCHREIBUNG
Vacu-Mix Plus ist ein Vakuumspritzen-Mischsystem, das
mit Knochenzementpulver vorgepackt ist. Das Produkt
ist nur für den einmaligen Gebrauch bestimmt und
steuert während der Vorbereitung von Knochenzement
Monomerdämpfe.
DePuy CMW 1 Gentamicin und DePuy CMW 3
Gentamicin Knochenzemente
röntgendichte, Zemente auf Polymethylmethacrylat-
Basis, die Antibiotika enthalten und bei arthroplastischen
Eingriffen zur Befestigung
Kunststoffprothesen an lebenden Knochen dienen.
Die Knochenzemente haben keine eigene, spezifische
Haftungsfähigkeit; vielmehr beruht die Haftung auf
einem engen, mechanischen Ineinandergreifen der
unregelmäßigen Knochenoberfläche und der Prothese.
Jede Verkaufspackung enthält:
• Eine mit Knochenzementpulver gefüllte Spritze
• Mischkappe mit Trichter
• Lieferdüse
• Dosierspindel
• Spachtel
• Vakuumrohr mit Kohlenstoff-Mikrobenfilter
• Ampulle(n) mit Knochenzementflüssigkeit.
Die mit Knochenzementpulver
Spritze sowie das
sterilen, doppelt abziehbaren Beutel geliefert. Die
Knochenzementflüssigkeit wird in einer sterilen Ampulle
in einer sterilen Blister-Verpackung geliefert. (Mit der
80-g-Einheit werden zwei Ampullen geliefert und mit
der 50-g-Einheit wird eine Ampulle geliefert). Der/
die Ampullenblister befindet/befinden sich auf einer
unsterilen Papphalterung. Die Komponenten sind
zusammen in einem unsterilen Schutzfolienbeutel
verpackt.
5
sind selbsthärtende,
von Metall-
vorgepackte
Zubehör werden in
oder
einem