DePuy Synthes Vacu-Mix Plus Folleto De Instrucciones página 6

Extrusion of the bone cement beyond the region of its intended
application may occur resulting in the following complications:
hematuria; dysuria; bladder fistula; delayed sciatic nerve
entrapment from extrusion of bone cement beyond the region
of its intended application; local neuropathy; local vascular
erosion and occlusion; and intestinal obstruction due to
adhesions and stricture of the ileum from the heat released
during the exothermic polymerisation.
Ensure that the powder and liquid components to be mixed
together have the same lot number, since the monomer
and polymer components are individually formulated for
each batch. It is essential to add all of the liquid and powder
components together when mixing the cement, since the
components are premetered to give optimum results.
Gentamicin bone cements are supplied sterile for single
use only. Do not re-use. Sterility is only guaranteed if the
packaging is unopened or undamaged. Resterilisation of
any components of the cements must not be attempted.
As the monomer is volatile and flammable, any waste
liquid component should be evaporated under a well-
ventilated hood or absorbed by an inert material and
transferred to a suitable container (which does not react
with the monomer) for disposal. The polymer component
and waste powder may be disposed in a landfill.
ADVERSE EVENTS
• Serious adverse events, some with fatal outcome,
associated with the use of bone cements include:
Myocardial infarction, cardiac arrest, cerebrovascular
accident, pulmonary embolism and anaphylaxis.
• The most frequent adverse reactions reported with
bone cements are:
Transitory fall in blood pressure, elevated serum
gamma-glutamyl-transpeptidase (GGTP) up to 10 days
post-operation, thrombophlebitis, haemorrhage and
haematoma, pain and/or loss of function, loosening
or displacement of the prosthesis, superficial or deep
wound infection, trochanteric bursitis, short-term cardiac
conduction irregularities, heterotopic new bone formation
and trochanteric separation.
• Other potential adverse events reported for bone
cements include:
Hypoxemia, cardiac arrhythmia, bronchospasm,
adverse tissue reaction, pyrexia due to allergy
to the bone cement, hematuria, dysuria, bladder
fistula, local neuropathy, local vascular erosion and
occlusion, transitory worsening of pain due to heat
released during polymerisation, delayed sciatic nerve
entrapment due to extrusion of the bone cement
beyond the region of its intended application, and
intestinal obstruction because of adhesions and
stricture of the ileum due to the heat released during
cement polymerisation.
INTERACTIONS WITH OTHER MEDICAMENTS
Bone cements containing gentamicin should not be
administered concurrently with other potentially ototoxic
or nephrotoxic drugs.
DIRECTIONS FOR USE
The following section applies only to the use of bone
cements in total joint replacement techniques.
The following statements should be read carefully prior
to the use of the Vacu-Mix Plus pre-packed with DePuy
CMW 1 Gentamicin and Vacu-Mix Plus pre-packed with
DePuy CMW 3 Gentamicin bone cements.
1. Bone cements are heat sensitive. Any increase or
decrease in temperature (either ambient, and/or of
the cement components and accessories), from the
recommended temperature of 73°F (23°C) will affect
the setting time of the cement. Note: Manual handling
and body temperature will reduce the final setting time.
2. Variations in humidity will affect the cement handling
characteristics and setting time.
3. The handling characteristics and setting time may
vary if the product has not been fully equilibrated
to 73°F (23°C) before use. It is recommended that
the unopened product is stored at 73°F (23°C) for a
minimum of 24 hours before use.
4. As with all bone cements, variations to the expected
setting time over the cement's shelf life can occur.
This variation in setting time can be reduced to a
minimum providing the cement is stored under the
recommended conditions throughout its shelf life.
5. Vacuum mixing of cement can noticeably accelerate
the setting time of the product compared to mixing in
an open mixing system. Users should be aware of
this and monitor the end of working and setting times
of the bone cement accordingly.
Cement Preparation
The protective outer foil pouch, the outer peelable pouch
of the syringe component and accessories, together
with the ampoule blister(s), are opened by a circulating
nurse. The inner peelable pouch containing the syringe
components and accessories, and sterile ampoule(s) are
aseptically transferred into the sterile operative area.
A dose is prepared by mixing the entire content of the
ampoule(s) with the entire contents of the syringe. The
amount of mixed material implanted is determined by the
clinical judgement of the surgeon in each individual case.
Vacu-Mix Plus pre-packed with DePuy CMW 1 Gentamicin
or DePuy CMW 3 Gentamicin is recommended for use with
the Vacu-Mix Plus Vacuum Generator (REF 3210020),
or Vacu-Mix Low Vacuum Footpump + Air hose
(REF 3210025) and the CMW Cement Gun - Mark III
(REF 3210-003).
NOTE: Please refer to the respective pump/gun labels and
instruction leaflet for further guidance on their use.
Cement Mixing and Vacu-Mix Plus Application
1. The inner peelable pouch is opened and the
economiser rod is loaded into the CMW Cement
Gun - Mark III.
2. The syringe barrel may be located in the stand; the
transit cap is removed.
3. The mixing cap and funnel are fitted into the syringe
barrel ensuring that the handle is fully lowered.
4. The vacuum tube has a carbon microbial filter
attached. The carbon microbial filter must only be
connected to the vacuum generator. The other end
of the vacuum tube must be connected to the mixing
cap (see diagram on the pouch).
5. The vacuum generator is switched on and kept on
throughout the mixing operation.
6. The monomer is poured into the syringe via the
funnel, ensuring that the entire contents of the
ampoule(s) are emptied out.
7. The funnel is removed, inverted and its snap off
plug is fully inserted into the hole in the handle thus
sealing off the mixing chamber.
4