Symbol Legend; Product Label; Specification; Functional Description - Arthrogen GOLDIC BTS Instructions D'utilisation

2.4

Symbol legend

Symbol Legend
Manufacturer
Date of manufacture: dd-mm-yyyy
Article number
Temperature limit
Consult operating instructions
Sterilization by irradiation
Sterilization by ethylene oxide
Not for reuse
Do not use if the packaging is damaged
Usable until
Batch number
2.5

Product Label

GOLDIC BTS and the GOLDIC SAS are each provided with a patient label, which is
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used to mark patient name, date and time of blood collection.
3.

Specification

3.1

Functional Description

GOLDIC is a platform technology using specially designed gold particles to produce
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an autologous conditioned serum. The GOLDIC
of endogenous regenerative and inflammatory factors (cytokines and various factors)
under the intended use of the medical device. The GOLDIC
device to optimize the body's own serum. This serum is injected into the defect zone as
part of a subsequent medical treatment as an autologous drug without additives. The aim
is to stimulate the body's own forces so that injured or damaged tissue can regenerate.
3.2

Scope of Delivery

The GOLDIC Set 4 / Ortho & Sport includes the following parts:
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• 4 x Arthrogen GOLDIC
• 4 x Arthrogen GOLDIC
• SARSTEDT AG & Co.: Multifly Needle 21G 200mm
• B BRAUN Melsungen AG: Discofix
• Instructions for Use
• 4 x Additional Patient Labels for the Patient File
NOTE:
Check the scope of delivery to see if all items are included. Should something be mis-
sing, contact the dealer from whom you received the GOLDIC
immediately.
3.3

Material Information

GOLDIC BTS:
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GOLDIC SAS:
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All components of the GOLDIC
3.4

Shelf Life

GOLDIC BTS and GOLDIC
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Please note the date of manufacture on the packaging.
Pay attention to the durability of the Multifly needle and the Discofix
stopcock, please note the manufacturer's instructions.
WARNING:
Check the shelf life of the products. Do not use products that are no longer durable. If
the serum filter shows a brownish discoloration, the GOLDIC
be discarded.
4.

Application

4.1

General Preparation

WARNING:
Check the product for integrity before use. Damage can cause injury and affect the
effectiveness of the therapy.
The production of the serum with the help of the GOLDIC
of the procedure. Please follow the recommendations of the respective societies for the
processing of blood products (hygiene regulations).
• Schedule the processing in the order of blood sampling.
• Only process the samples of a single patient and thus avoid the risk of mixing
samples.
• Document the individual steps according to the quality management system of
your medical practice or the hospital. Please also note the general requirements of
pharmaceutical legislation.
••
technology leads to an accumulation
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BTS (Blood-Taking-System), REF 44500-0001
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SAS (Serum-Application-System), REF 44500-0101
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C-3-way Stopcock
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Polypropylene, Polyethylene, Gold Particles
Polypropylene, Thermoplastic Polymer, Polyether Sulfone
BTS and the GOLDIC SAS are free of latex.
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SAS are sterile products and have a shelf life of 2 years.
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set is the most important step
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set serves as a medical
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Set 4 / Ortho & Sport
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C-3 three-way
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SAS is unusable and must
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