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Required Material / Accessories:
•
GOLDIC
- Set 4 / Ortho & Sport
®
•
Optional GOLDIC
Serum-Transfer-Device (STD)
®
•
Sterile caps for Luer- Lock syringes or hypodermic needles
•
Tube stand plate
•
Standard alcoholic disinfectant
•
Adhesive dressing
•
Disposable pad
•
Sterile gloves
•
Swabs
•
Incubator (37°C); (f.e. Selzer Thermocult)
•
Centrifuge (10ml inserts, minim. 4.000 rpm); (f.e. Hettich EBA 270)
•
Freezer (-18°C); (f.e. Gram BioLine – BioCompact-RF-210)
•
Lab book for documentation
•
Multi-Safe box for disposal
•
Optional GOLDIC
®
Cryo-Box
NOTE:
Other accessories may be used as long as the technical specifications are met.
4.2
Venous Blood Sampling
Use the usual aseptic techniques in the procedure described below. For blood collec-
tion, use the Multifly needle and the Discofix
GOLDIC
Set 4 / Ortho & Sport.
®
•
Record the patient data.
•
Inform the patient about the purpose and procedure of the intended treatment.
•
Prepare the blood sample. The blood sample should be taken venous (for example
from the arm vein).
•
Remove the cap of the GOLDIC
directly to the three-way stopcock. Up to 2 Blood-Taking-Systems (BTS) can be
connected to the three-way stopcock at the same time.
CAUTION:
Do NOT use any anticoagulants !
•
Slowly draw the patient's blood into the Blood-Taking-System (BTS) until the BTS-
tube is completely filled. Pull out the piston from the syringe to raise the plunger
backwards.
•
Remove the BTS-tube from the three-way stopcock.
•
Screw cap onto port of the BTS- tube and make sure that it is locked tight.
•
Bend off the plunger of the BTS-tube and swivel the filled blood collection tube
several times to achieve a thorough mixing of the patient's blood with the gold
particles.
•
Then mark the patient label of the BTS-tube with the patient's name, date and time
of the blood collection.
•
Repeat this process until all 4 BTS-tubes are filled.
•
Remove the Multifly needle and the Discofix
the patient with a wound dressing.
•
Dispose of the Multifly needle and the Discofix
Multi-Safe box.
4.3
Serum Preparation
•
Store the filled blood collection tubes for 24 hours in the incubator at 37°C.
The prescribed incubation period should not be exceeded and monitored by a
healthcare professional.
•
Check that the cap of the BTS-tubes are tightly closed. Place the blood collec-
tion tubes in the centrifuge with the cap facing up. Subsequently, the BTS-tubes
are centrifuged for about 10 minutes at 4,000 rpm with the aid of a laboratory
centrifuge.
•
In centrifuges with V-bottom hanger, it may happen that the plunger of the BTS-
tube after the centrifugation process protrudes a few millimeters. Please push the
plunger back to the starting position.
•
You can optionally transfer the serum to the GOLDIC
tem (SAS) with the Serum-Transfer-Device (STD) or without the Serum-Transfer-
Device (STD):
C-3 three-way stopcock contained in the
®
BTS and connect the blood collection system
®
C-3 three-way stopcock and provide
®
C-3 three-way stopcock in the
®
Serum-Application-Sys-
®
- Using the GOLDIC
Serum-Transfer-Device (STD):
®
•
Place the BTS-tube with the cap up in the GOLDIC
•
Turn the blood collection tube (BTS) 45 ° to the right to fix it.
•
Open the cap of the blood collection tube (BTS).
•
Clean the top of the BTS-tube with disinfectant.
•
Connect the BTS-tube to the Luer-Lock connection of the GOLDIC
Application-System (SAS) tube.
•
Press both buttons of the GOLDIC
transfer the serum through the filter into the GOLDIC
•
Remove the BTS-tube and the filter from the GOLDIC
(SAS) and seal the GOLDIC
®
injection cannula.
•
The removed BTS-tube and the used filter are discarded (according to the hy-
giene standards and the usual waste management plans in medical practices and
hospitals).
•
Then mark the patient labels of the GOLDIC
name, date and time of serum production.
- Transfer of serum without the GOLDIC
•
Open the cap of the blood collection tube (BTS).
•
Clean the top of the BTS-tube with disinfectant.
•
Connect the BTS-tube to the Luer-Lock connection of the GOLDIC
Application-System (SAS) tube.
•
Now hold the GOLDIC
SAS-tube vertically in your hand and pull the syringe
®
plunger down to transfer the serum through the filter into the GOLDIC
•
Remove the BTS-tube and the filter from the GOLDIC
(SAS) and seal the GOLDIC
®
injection cannula.
•
The removed BTS-tube and the used filter are discarded (according to the hy-
giene standards and the usual waste management plans in medical practices and
hospitals).
•
Then mark the patient labels of the GOLDIC
name, date and time of serum production.
4.4
Serum Usage
•
Immediately inject the serum or store the prepared GOLDIC
GOLDIC
storage box recommended by us at -18 ° C in a freezer until the next
®
treatment. Please check the integrity and labeling of GOLDIC
•
Document the procedure in your lab book (patient name, date, number of
GOLDIC
SAS syringes, abnormalities).
®
Four (4) injections are recommended for complete treatment.
5.
Other Information
5.1
Disposal
Dispose of all used products according to the disposal guidelines for medical practices
and hospitals.
5.2
Contact
For product information of any kind, in case of error or handling questions, please con-
tact your local distributor or us at:
Arthrogen GmbH
Wiesseer Straße 103
83707 Ringsee
Germany
Phone:
+49 8022 18740415
E-Mail:
info@arthrogen.com.de
Homepage:
www.arthrogen.com.de
Serum-Transfer-Device.
®
Serum-Transfer-Device (STD) down, to
®
SAS-tube.
®
Serum-Application-System
®
SAS-tube with a new, more sterile cap or sterile
SAS syringes with the patient's
®
Serum-Transfer-Device (STD):
®
Serum-Application-System
®
SAS-tube with a new, more sterile cap or sterile
SAS syringes with the patient's
®
SAS syringes in the
®
®
SAS syringes.
Serum-
®
Serum-
®
SAS-tube.
®
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