Table des Matières
Publicité
Les langues disponibles
Les langues disponibles
GOLDIC
INSTRUCTIONS FOR USE - ENGLISH
Table of contents
1.
1.1
2.
2.1
2.2
2.3
2.4
2.5
3.
3.1
3.2
3.3
3.4
4.
4.1
4.2
4.3
4.4
5.
5.1
5.2
Contact
Copyright Notice
Copyright
Arthrogen GmbH
©
All rights reserved. The content of this document may not be copied or reproduced
without the written permission of Arthrogen GmbH.
All company names and designations used in this document are registered trademarks
and brands and may not be used commercially or in any other way. Changes in the
design and in the scope of delivery are reserved as part of the technical development.
Arthrogen GmbH
Wiesseer Straße 103
83707 Ringsee
Germany
1.
Medical Application GOLDIC
1.1
Intended Use and Indication
The GOLDIC
Set (Gold Induced Cytokine Set) is a medical device designed to specif-
®
ically process autologous blood. It allows the rapid and efficient accumulation of serum
with cytokines and growth factors.
The GOLDIC
Set includes the following parts:
®
•
Blood-Taking-System (BTS)
•
Serum-Application-System (SAS)
•
Butterfly needle
•
Three- way tap to connect the BTS- tube
The Blood-Taking-System (BTS) is used to remove a small amount of patient blood from
the vein, this blood is incubated in the presence of defined gold particles for 24 hours in
an incubator and then the blood cells and the gold particles are separated by centrifuga-
tion from the serum. A special filter in the Serum-Application-System (SAS) prevents the
gold particles or blood cells from entering the patient´s body with the serum.
The GOLDIC
Set is intended for the physician to prepare for an individual treatment of
®
inflammatory and degenerative diseases. Here one uses the positive effect of the gold
while avoiding any side effects.
The GOLDIC
set can be used in professional health care facilities, such as doctors'
®
offices, hospitals, clinics and other medical facilities.
The blood collection should only be performed by trained medical specialists. The pro-
duction of the GOLDIC
Serum may only be carried out by trained medical personnel
®
under medical supervision.
Patients over the age of 18 can be treated with the GOLDIC
SET
®
®
®
technology.
®
2.
Safety
2.1
Read this manual completely. Keep the instructions for future reference. Failure to follow
the instructions for use may result in injury or damage to the product.
2.2
Design of Warnings and Safety Instructions
NOTE:
Notes are general precautions that may result in adverse effects or short-term inconve-
nience.
CAUTION:
The signal word CAUTION indicates hazards that, if disregarded, could result in minor or
moderate injury or impairment of therapy.
WARNING:
The WARNING signal word identifies hazards that, if disregarded, could result in serious
injury or severe damage to the therapy
2.3
General Safety Information
CAUTION:
Users should exercise caution when handling surgical needles to prevent inadvertent
needle sticks. Dispose of used needles in multi-safe boxes.
WARNING:
Damaged or opened components which are marked as sterile must not be used.
WARNING:
The products are disposable and must not be reused or re-sterilized.
WARNING:
Do a comprehensive anamnesis before each treatment and explain the patient about the
contraindications and possible side effects.
WARNING:
Use the prepared GOLDIC
serum within 4 hours after cultivation or freeze the unused
®
serum tubes at -18°C or above. The serum can be stored for up to 6 weeks at -18°C. Do
not use GOLDIC
serum stored for more than 4 hours at room temperature.
®
WARNING:
GOLDIC
should only be used by properly trained personnel. Contact Arthrogen GmbH
®
or your local distributor for training.
WARNING:
Store the GOLDIC
Set in its original unopened packaging in a dry and clean place.
®
Protect the product from moisture.
.
Publicité
Chapitres
Table des Matières
