Precautions For Use - Cousin Biotech Rescube Gebrauchsanweisung

PRECAUTIONS FOR USE

General precautions
ResCUBE devices must be implanted by specialist spinal surgeons, trained in the surgical technique. The information
contained in this leaflet is necessary but not sufficient to master the surgical technique.
IMPORTANT: DO NOT RE-USE - DO NOT RESTERILISE
ResCUBE implants are supplied sterile and for single use. They must not be resterilised or re-used (potential risks include
but are not limited to: loss of product sterility, risk of infection, loss of effectiveness, relapse).
Implants must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature.
Pre-operative precautions
The implantation decision must be taken by the surgeon, after informed consent of the patient, considering the indications,
contra-indications and potential undesirable side effects.
Before the surgery, it is recommended to check the compatibility oП НОvТМОs аСТМС аТll ЛО КssoМТКtОН ΧsТгО, mКtОrТКls...Ψέ
Peroperative precautions
Before opening, it is recommended to check the packaging is untampered with. Any damage on packaging may
jeopardise the implant sterility. If the packaging is damaged, the implant must not be used, or resterilised.
Any implant whose expiration date has passed must not be used.
After opening, it is recommended to check the implant integrity.
Any implant with a damaged surface must not be implanted.
The placement of the implant must be done with the appropriate ancillaries, following the surgical technique
recommended by COUSIN BIOTECH.
The malleable metal lamella and the sleeve linking it to the braid are not intended for long term implantation and must be
removed after placement of the implant.
Post-operative precautions
The patient must be informed of the post-operative care and of precautions.
RETRIEVAL AND DISPOSAL OF DEVICES
Retrieval and handling should be done in compliance with ISO 12891-1:2011 « Implants for surgery – Retrieval and
analysis of surgical implants » Part 1: « Retrieval and Handling ».
Any removed device must be sent back for analysis, following the current protocol. The latter is available on request to
COUSIN BIOTECH. It is important to note that any implant that cannot be cleaned and disinfected before despatch must
be contained in a sealed package.
The disposal of removed medical devices must be conducted according to national standards for the disposal of infectious
hazards waste.
The disposal of a non-implanted device is not subject to specific recommendations.
INFORMATION REQUESTS AND CLAIMS
Following its quality policy, COUSIN BIOTECH is committed to make every effort to produce and supply high quality
medical devices. However, if a health professional (client, user, prescriber ...) has a complaint or cause for dissatisfaction
with a product in terms of quality, safety or performance, he must inform COUSIN BIOTECH as soon as possible.
In case of dysfunction of an implant or if it contributed to causing serious adverse effects for the patient, the health centre
must follow the legal procedures in its country, and inform COUSIN BIOTECH as soon as possible.
For any correspondence, please specify the reference, batch number, details of a reference and a comprehensive
description of the incident or complaint.
Brochures, documentation and surgical techniques are available on request from COUSIN BIOTECH and its distributors.
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