Heraeus PALAMIX Gebrauchsanweisung Seite 8

PALAMIX
EN (US)
Note: Instructions for use for sale within the US.
General information
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PALAMIX is a vacuum mixing and application system for
bone cements. It consists of:
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– PALAMIX uno or PALAMIX
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– PALAMIX cement gun
– c ompressed air-operated PALAMIX
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PALAMIX uno and PALAMIX
collection of bone cement within the mixing cartridge
under vacuum.
Components
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PALAMIX
uno (details for PALAMIX
contains the following sterile articles:
• 1 (2) mixing cartridge, large enough to hold up to two
(four) 40 g packs of Heraeus Medical bone cement
• 1 (2) mixing rod with integrated mixing paddle and noz-
zle
• 1 (1) funnel
• 1 (1) vacuum hose with activated charcoal filter
• 1 (1) femoral pressuriser
• 1 (1) knee pressuriser
• 1 (2) short nozzle
• 1 (1) work tray
All components are not made with natural rubber latex and
all components that come into contact with bone cement
are not made with PVC.
Usage
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PALAMIX enables bone cements to be mixed homogene-
ously and achieve a void-free consistency. It is suitable for
bone cements with different viscosities. Additional
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PALAMIX nozzles are available in different lengths and
diameters for applying bone cement in diverse indications.
Product Overview
Product
PALAMIX uno
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PALAMIX duo
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PALAMIX slim nozzle
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PALAMIX medium nozzle
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PALAMIX
cement gun
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PALAMIX vacuum pump
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duo vacuum mixing system
vacuum pump
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duo allow for automatic
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duo in brackets)
Description
Vacuum mixing system with collection under
vacuum
Vacuum mixing system with collection under
vacuum, with two cartridges
For use with low-viscosity bone cements; ∅ 7 mm
Flexible, conical nozzle; ∅ 8.7 – 12.6 mm
Reusable application gun
Vacuum pump with non-return valve
Caution
Federal law restricts this device to sale, distribution,
and use by or on the order of a physician.
Bone cement
The sequence described in these instructions is optimised
to suit Heraeus bone cements. If you are using bone
cements from other manufacturers, please observe their
specifications and sequence for filling the vacuum mixing
systems.
Warnings
Read these instructions for use before using for the first
time and familiarise yourself with operation of the system.
Test the bone cement properties and handling of PALAMIX
beforehand to account for your specific surgical conditions.
During use, ensure that a suitable distance is left between
non-sterile items and the sterile PALAMIX
Shelf life/sterility
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PALAMIX uno and PALAMIX
ene oxide and cannot be reused or resterilised.
Precautions
The PALAMIX
vacuum mixing system should be examined
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for damage prior to use. If the sterile packaging is dam-
aged or the shelf life exceeded, the PALAMIX
mixing system must be discarded.
Storage
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PALAMIX vacuum mixing systems have to be stored in a
dry and clean place.
Should you require further information, your Heraeus
Medical partners would be pleased to assist you.
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components.
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duo are sterilised with ethyl-
vacuum
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Quantity per
Article number
sales unit
10 66057893
10 66057897
10 66036747
10 66043960
1 66036163
1 66036748
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