AQ Implants REVISIO RTM Gebrauchsanweisung Seite 9

2. Handling
Keep the implant in the unopened original packaging until it is used. When unpacking the
implant, please ensure that the protective packaging, i.e. cardboard and peel film, is unopened
and intact. Any damage may impair the sterility of the implant. In the event of a broken seal or
damaged cardboard and peel film, it must be assumed that the contents are no longer sterile.
Caution:
If the seal is broken, the product cannot be returned.
When unpacking the implants, please verify the details on the packaging against the package
contents (item number and size) as well as expiry date. Do not implant components after the
expiry date stated on the package.
Caution:
Make sure that all aseptic standards are observed during removal of sterile implant components.
Take appropriate measures to avoid that the implant comes into contact with objects or sub-
stances that might damage its surface. This applies particularly for coated implants (calcium
phosphate [CaP], Titanium-Niobium [TiNb] etc.) e.g. for the contact with body fluids (sweat,
blood, synovia, etc.). For ceramic implants this also applies for the direct contact with skin.
Please note the enclosed user information and surgical techniques. Visually inspect implant and
coating (where applicable) for damage prior to implantation. Damaged implants or implant com-
ponents must not be implanted. Protective caps or similar devices for the protection of sensitive
implant areas are removed immediately before use. Implants must not be processed mecha-
nically, altered or modified, unless this is explicitly required by the surgical technique or the
manufacturer has given his written consent.
Caution:
Products that have been implanted must not be reused. The same applies for implants that came
into contact with foreign body fluids.
Removal, handling and return of revised implants for scientific evaluation must be performed in
accordance with ISO 12891-1. Please observe the general information of ISO 8828 on the care
and handling of orthopaedic implants! For specific items, please observe the manufacturer's
instructions (handling, sterilisation, compatibility, etc.).
3. Packaging and sterility
All implants are packed individually in sterile protective packages. Sterile implants have been
sterilised with a minimum gamma radiation dose of 25 kGy.
Caution:
Any implants labelled „sterile" are only sterile, if the package has not been opened.
Caution:
Implants must not be resterilised. Any reprocessing of non-implanted components with opened
packages or expired sterile date must only be performed by the manufacturer, as several validated
processes have to be performed again.
These instruments can be autoclaved using standard procedures (autoclave according to DIN
EN 285, procedure according to DIN EN ISO 17665-1 and DIN EN ISO 14937), provided the
required sterilisation temperatures and cycle times are observed. Prior to resterilisation, all in-
strument components should be disassembled as far as possible. Please refer to the „Reproces-
sing guidelines for the reprocessing of reusable surgical instruments" of AQ Implants GmbH for
detailed information.
Note:
Implants for use with or without bone cement are marked with the following abbreviations:
• Implants intended for use with bone cement: C (cemented)
• Implants intended for use without bone cement: CL (cementless)
4. Surgical planning
Preoperative planning is based on the radiographic evaluation. Appropriate X-ray templates are
available. Moreover, all products of AQ Implants GmbH are available in the digital planning
system mediCAD .
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For the preparation of the host bone and adjustment, repositioning as well as implantation of the
implants, specific instruments and trial implants corresponding to the dimensions of the implants
are available. Please don't use other trial instruments or implants.
The appropriate surgical technique is selected in accordance with the latest state of science and
technology. In addition, AQ Implants GmbH provides surgical techniques upon request which
are constantly revised in view of new findings and understanding.