Kit Monouso PRGF®-Endoret® Traumatologia - BTI Biotechnology ...

Endoret ® Kit orthopedics (4 tube sets) and
Endoret ® Kit orthopedics (8 tube sets)
en
Intended use: ENDORET® KIT ORTHOPEDICS (4 tube sets) and ENDORET®KIT ORTHOPEDICS (8 tube sets) are systems for
obtaining Plasma Rich in Growth Factors which can be used in the regeneration of bone or other connective tissues for the
treatment of musculoskeletal injuries.
Product description: The ENDORET® KIT ORTHOPEDICS (4 tube sets) and ENDORET® KIT ORTHOPEDICS (8 tube sets) contain
8 single-use kits each.
ENDORET® KIT ORTHOPEDICS (4 tube sets) (Ref. BTI: EDK1; Ref. S&N 72203574):
The Endoret® Kit Orthopedics (4 tubes) is recommended to obtain 8 ml of plasma.
Each single-use Endoret® Kit Orthopedics (4 tubes) is composed of two blisters.
Blister 1
REF. BTI DESCRIPTION STERILITY
PTD-EST BTI PLASMA TRANSFER DEVICE (PTD) Plasma-drawing system Sterile
Blister 2
REF. BTI DESCRIPTION STERILITY*
TE9
TF9-EST
4 BTI collection tubes for obtaining Plasma Rich in Growth Factors
(sterile vacuum tubes with 3.8% citrate solution as anticoagulant).
8.1-ml collection volume. Light blue cap. Black ring.
2 BTI fractionation tubes for obtaining Plasma Rich in Growth
Factors (sterile vacuum tubes). White cap. Black ring.
Sterile interior tube;
Non-sterile exterior
PE 1 Vacuette winged butterfly set Sterile
PRGF-ACT-EST 1 1-ml PRGF® activator ampoule (calcium chloride) Sterile
GP31280
1 Syringe for drawing PRGF® Activator:
BD Micro-Fine 0.5 ml 29G x 12.7 mm
Sterile
* Note: Blister 2 is non-sterile. See the “Sterility” column in the previous table to check the sterility of each component.
ENDORET® KIT ORTHOPEDICS (8 tube sets) (Ref. BTI: EDK2; Ref. S&N 72203575):
The Endoret® Kit Orthopedics (8 tubes) is recommended to obtain 16 ml of plasma.
Each single-use Endoret® Kit Orthopedics (8 tubes) is composed of two blisters.
Blister 1
REF. BTI DESCRIPTION STERILITY
PTD-EST BTI PLASMA TRANSFER DEVICE (PTD): plasma-drawing system Sterile
Blister 2
REF. BTI DESCRIPTION STERILITY*
TE9
8 BTI collection tubes for obtaining Plasma Rich in Growth Factors
Sterile interior tube;
(sterile vacuum tubes with 3.8% citrate solution as anticoagulant).
Non-sterile exterior
8.1-ml collection volume. Light blue cap. Black ring.
TF9-EST
4 BTI fractionation tubes for obtaining Plasma Rich in Growth
Factors (sterile vacuum tubes).
Sterile
White cap. Black ring.
PE 1 Vacuette winged butterfly set Sterile
PRGF-ACT-EST 2 1-ml PRGF® Activator ampoules (calcium chloride) Sterile
GP31280
1 Syringe for drawing PRGF® Activator:
BD Micro-Fine 0.5 ml 29G x 12.7 mm
Sterile
* Note: Blister 2 is non-sterile. See the “Sterility” column in the previous table to check the sterility of each component.
Contraindications
No contraindications or side effects have been identified.
Precautionary measures
1. Handle all biological samples and blood collection “sharps” (lancets, needles, Luer adapters, and blood collection sets)
according to the safety and sanitation policies and procedures of your facility.
2. Viruses (such as Hepatitis B and C, HIV (AIDS) and other infectious diseases) may be transmitted by contact with biological
samples. In the event of any exposure to biological samples, obtain appropriate medical attention.
3. If blood is collected through an intravenous line, ensure that the line has been cleared of any medication or chemical
solution. Flush and waste according to your facility’s blood draw policy.
4. All liquid additives in blood tubes should be colorless and odorless. Do not use tubes if the color of the additive has changed.
Do not use tubes or activator if any sediment is observed in the liquid.
5. The re-use and/or re-sterilization of these products may cause risk of infection and/or cross contamination.
Sterile
page 5 of 44