Kit Monouso PRGF®-Endoret® Traumatologia - BTI Biotechnology ...
Kit Monouso PRGF®-Endoret® Traumatologia - BTI Biotechnology ... Kit Monouso PRGF®-Endoret® Traumatologia - BTI Biotechnology ...
6. Always follow your facility’s protocol for blood draws. 7. Children, pregnant and nursing women: There are no additional precautions in any of these conditions. However, each individual patient situation should be considered by the physician before using the PRGF system. Aseptic Practice 1. Follow your facility’s aseptic operation procedures to minimize the risk of microbiological contamination of the PRGF-ENDORET® fractions. 2. The use of an appropriate laminar flow cabinet for the fractionation and activation processes will reduce the risk of microbiological contamination. Waste disposal 1. Observe your organization’s general directives on hygiene and legal regulations governing the proper disposal of infectious material and sharps. 2. Wear gloves to reduce risk of exposure to biological materials. 3. Full collection tubes or tubes containing contaminated blood must be placed in appropriate containers designed for the disposal of potentially infectious waste material. 4. Waste disposal usually involves incineration or autoclaving (steam sterilization). Storage measures Storage temperature: keep at 4-25ºC WARNING: Exceeding the maximum storage temperature may lead to impairment of the tube quality (i.e. vacuum loss, drying out of liquid additives, decoloring, etc.). Do not use after expiration date. Keep away from direct sunlight. Instructions for Use 1. Blood Collection Wear gloves during blood collection and while handling blood collection tubes to minimize hazard exposure. Blood should be used within 4 hours of draw. Do not draw blood if planning to use more than 4 hours from time of draw. 1. Select the number of blue tubes required to prepare the necessary PRGF. NOTE: PRFG collection tubes contain additives. Therefore it is important to avoid potential backflow from the tube, due to the possibility of adverse patient reactions. To prevent backflow from tube into the patient’s arm, observe the following precautions: a) Place patient’s arm in a downward position. b) Hold tube upright with the cap at the top. c) Release tourniquet as soon as blood starts to flow into the tube. d) Make sure tube contents do not touch the cap of the tube during this procedure. 2. Apply a tourniquet (max. 1 minute to prevent hemolysis). Prepare the venipuncture site with an antiseptic wipe. Do not touch the venipuncture area after cleansing. 3. Extract butterfly with silicone tube and adapter from its sterile wrap. 4. Remove needle shield. 5. Perform venipuncture with patient’s arm in a downward position. 6. Push tube into the holder and onto the needle valve puncturing the rubber diaphragm. Center tubes in holder when penetrating the cap to prevent sidewall penetration and subsequent premature vacuum loss. 7. Remove tourniquet as soon as blood appears in the tube. Do not allow contents of tube to contact the cap during procedure. Do not hold the tube upside down and always hold in place by pressing the tube with the thumb to ensure complete vacuum draw 8. When the first tube is full and blood flow ceases, gently remove it from holder. NOTE: If no blood flows into the tube or if blood flow ceases before an adequate sample is collected, the following steps are suggested to complete satisfactory collection: a) Push tube forward until tube cap has been penetrated. Always hold in place by pressing the tube with the thumb to ensure complete vacuum draw. b) Confirm correct position of needle in vein. c) If blood still does not flow, remove tube and place new tube onto the holder. d) If this action is unsuccessful too, remove needle and discard. Repeat procedure from step 1 9. Gently invert the tubes 4-6 times immediately after blood collection to mix blood with tube additives. Turn the filled tube upside-down and return it to upright position. This is equivalent to a complete inversion. NOTE: Do not shake the tubes. Vigorous mixing may cause foaming, hemolysis and platelet activation leading to poor ENDORET® Technique results. Inadequate mixing may also generate undesirable results. 10. Repeat steps 6, 7, 8 with the remaining tubes. 11. As soon as blood stops flowing in the last tube, remove needle from vein, applying pressure to puncture sit with dry sterile swab until bleeding stops. Once clotting has occurred, apply a sterile dressing. NOTE: After venipuncture, the top of the cap may contain residual blood. Take proper precautions when handling tubes to avoid contact with this blood. Any equipment contaminated with blood is considered hazardous and should be disposed of immediately. 12. Discard the used needle with holder using an appropriate disposal device. DO NOT RECAP. Recapping of needles increases the risk of needle stick injury and blood exposure. NOTE: Blood may occasionally leak from the needle sleeve. Practice universal safety precautions to minimize hazard exposure. page 6 of 44
2. Centrifugation: Tubes filled with blood should be centrifuged within a maximum of one hour. Under no circumstances should they be refrigerated. BTI TUBES SHOULD ONLY BE CENTRIFUGED USING A BTI SYSTEM IV CENTRIFUGE. To assure that fractions are properly separated and ready for necessary clinical applications. Please refer the BTI System IV Centrifuge instructions for use to complete this procedure. Through centrifugation, the blood is separated into its three basic components: • Plasma rich in growth factors: plasma (yellowish color) contains the largest volume of platelets, distributed according to an increasing density gradient (i.e., the platelet count is smaller in the upper part of the tube and increases gradually toward the bottom of the plasma layer). • White blood cells or leukocytes: the thin grayish-white layer deposited just above the red blood cells (also known as buffy coat). • Red blood cells: red layer at the bottom of the tube. 3. Fractionation using PLASMA TRANSFER DEVICE (PTD) Before starting fractionation, record the total volume of plasma (Vt) obtained after centrifugation by using the volume indications that appear on the tube label (Vt depends on the patient’s haematocrit). 1. Using Sterile gloves, remove the blue caps of collection tubes centrifuged and placed in the GT 16 tube rack (Ref. S&N: 72203572). being careful not to mix the blood fractions. 2. Remove the PTD from the sterile blister. 3. Remove the protecting tube from the cannula. 4. Insert tube 1 at the back of the BTI PLASMA TRANSFER DEVICE (PTD). 5. Place the cannula of the PTD in the upper surface of the plasma fraction to be drawn. Keep tip of cannula just below the plasma surface (about 1-2 millimeters) and touching the edge of the tube glass. 6. Gently press the blue button on the PTD to start drawing the F1 plasma fraction, while simultaneously moving the cannula along the descending volume of the plasma so that the cannula always stays at the upper surface of the fraction to be drawn. Proceed slowly to avoid turbulence. 7. Stop drawing when there are about 2 ml of plasma left over the buffy coat layer. WARNING: DO NOT DRAW AIR. Pushing the blue button while the PTD tip is in the air will cause the PTD to eject the plasma back out of the fractioning tube. 8. Repeat Steps 5, 6 & 7 for each BTI TE9 collection tube (previously centrifuged) with the same PTD and fractionation tube, then remove the fractionation tube and place it in a sterile tube rack (Ref. BTI: GTT; Ref. S&N 72203573). Figure 1: Vt F1 F2 FRACTION 1 Vt - 2 ml FRACTION 2 2 ml White blood cells Red blood cells 9 ml tube 9. Repeat Steps 4-8 for drawing F2 from all the blood collection tubes. You may draw Fraction 2 up to 1 ml from the grayish white buffy coat, but it is important to not draw contents from the buffy coat. 10. Place all F1 fractions obtained from the patient in the same plasma fractionation tube. 11. Place all F2 fractions obtained from the patient in the same plasma fractionation tube. 12. Discard the BTI PLASMA TRANSFER DEVICE (PTD) single-use device; NON REUSABLE. 4. Platelet Activation Protocol WARNING: The plasma should not be kept longer than four hours after blood collection. For plasma activation, estimate the plasma volume contained in the Fraction tube intended for use. • Fraction 2 contains higher number of platelets and growth factors upon activation. It can be used in a liquid form (activated) or as a clot. • Fraction 1 is recommended for fibrin membrane preparation. Use graft containers (Ref. BTI: RPI40, RPI50 & RPI60; Ref. S&N: 72203583, 72203584 and 72203585, respectively) to conveniently prepare the membranes. 1. Using the BD Micro-fine drawing syringe, draw the necessary PRGF® Activator volume in the ratio of 0.05 ml (5 units in the BD Micro-fine syringe scale) of PRGF® Activator per milliliter of plasma. Note: Be aware that the BD Micro-fine drawing syringe is labeled in UNITS, not milliliters. Conversion is critical to prevent errors. page 7 of 44
- Page 1 and 2: Kit Endoret ® traumatología (set
- Page 3 and 4: NOTA: No agitar los tubos. Una mezc
- Page 5: Endoret ® Kit orthopedics (4 tube
- Page 9 and 10: Set Endoret ® traumatologie (4-rö
- Page 11 and 12: 9. Um eine gute Durchmischung von Z
- Page 13 and 14: Kit Endoret ® traumatologie (sets
- Page 15 and 16: également produire des résultats
- Page 17 and 18: Kit Endoret ® traumatologia (confe
- Page 19 and 20: 9. Subito dopo il prelievo di sangu
- Page 21 and 22: Kit Endoret ® traumatologia (sets
- Page 23 and 24: 10. Repetir os passos 6, 7 e 8 com
- Page 25 and 26: Endoret ® -Kit traumatologi (4 sæ
- Page 27 and 28: 12. Bortskaf den nål, der blev bru
- Page 29 and 30: Endoret ® Kit traumatologia (4 put
- Page 31 and 32: 2. Sentrifugointi Kun putket ovat t
- Page 33 and 34: Endoret ® Kit traumatologie (sets
- Page 35 and 36: 9. Keer onmiddellijk na bloedafname
- Page 37 and 38: Endoret ® Kit traumatologi (4 slan
- Page 39 and 40: 2. Sentrifugering Når rørene er f
- Page 41 and 42: Endoret ® Kit traumatologisats (4
- Page 43 and 44: OBS! Efter venpunktionen kan det fi
2. Centrifugation:<br />
Tubes filled with blood should be centrifuged within a maximum of one hour. Under no circumstances should they be refrigerated.<br />
<strong>BTI</strong> TUBES SHOULD ONLY BE CENTRIFUGED USING A <strong>BTI</strong> SYSTEM IV CENTRIFUGE. To assure that fractions are properly separated<br />
and ready for necessary clinical applications.<br />
Please refer the <strong>BTI</strong> System IV Centrifuge instructions for use to complete this procedure.<br />
Through centrifugation, the blood is separated into its three basic components:<br />
• Plasma rich in growth factors: plasma (yellowish color) contains the largest volume of platelets, distributed according to an<br />
increasing density gradient (i.e., the platelet count is smaller in the upper part of the tube and increases gradually toward<br />
the bottom of the plasma layer).<br />
• White blood cells or leukocytes: the thin grayish-white layer deposited just above the red blood cells (also known as<br />
buffy coat).<br />
• Red blood cells: red layer at the bottom of the tube.<br />
3. Fractionation using PLASMA TRANSFER DEVICE (PTD)<br />
Before starting fractionation, record the total volume of plasma (Vt) obtained after centrifugation by using the volume indications<br />
that appear on the tube label (Vt depends on the patient’s haematocrit).<br />
1. Using Sterile gloves, remove the blue caps of collection tubes centrifuged and placed in the GT 16 tube rack (Ref. S&N: 72203572).<br />
being careful not to mix the blood fractions.<br />
2. Remove the PTD from the sterile blister.<br />
3. Remove the protecting tube from the cannula.<br />
4. Insert tube 1 at the back of the <strong>BTI</strong> PLASMA TRANSFER DEVICE (PTD).<br />
5. Place the cannula of the PTD in the upper surface of the plasma fraction to be drawn. Keep tip of cannula just below the<br />
plasma surface (about 1-2 millimeters) and touching the edge of the tube glass.<br />
6. Gently press the blue button on the PTD to start drawing the F1 plasma fraction, while simultaneously moving the cannula<br />
along the descending volume of the plasma so that the cannula always stays at the upper surface of the fraction to be<br />
drawn. Proceed slowly to avoid turbulence.<br />
7. Stop drawing when there are about 2 ml of plasma left over the buffy coat layer.<br />
WARNING: DO NOT DRAW AIR. Pushing the blue button while the PTD tip is in the air will cause the PTD to eject the plasma<br />
back out of the fractioning tube.<br />
8. Repeat Steps 5, 6 & 7 for each <strong>BTI</strong> TE9 collection tube (previously centrifuged) with the same PTD and fractionation tube,<br />
then remove the fractionation tube and place it in a sterile tube rack (Ref. <strong>BTI</strong>: GTT; Ref. S&N 72203573).<br />
Figure 1:<br />
Vt<br />
F1<br />
F2<br />
FRACTION 1<br />
Vt - 2 ml<br />
FRACTION 2<br />
2 ml<br />
White blood cells<br />
Red blood cells<br />
9 ml tube<br />
9. Repeat Steps 4-8 for drawing F2 from all the blood collection tubes. You may draw Fraction 2 up to 1 ml from the grayish<br />
white buffy coat, but it is important to not draw contents from the buffy coat.<br />
10. Place all F1 fractions obtained from the patient in the same plasma fractionation tube.<br />
11. Place all F2 fractions obtained from the patient in the same plasma fractionation tube.<br />
12. Discard the <strong>BTI</strong> PLASMA TRANSFER DEVICE (PTD) single-use device; NON REUSABLE.<br />
4. Platelet Activation Protocol<br />
WARNING: The plasma should not be kept longer than four hours after blood collection.<br />
For plasma activation, estimate the plasma volume contained in the Fraction tube intended for use.<br />
• Fraction 2 contains higher number of platelets and growth factors upon activation. It can be used in a liquid form (activated)<br />
or as a clot.<br />
• Fraction 1 is recommended for fibrin membrane preparation. Use graft containers (Ref. <strong>BTI</strong>: RPI40, RPI50 & RPI60; Ref. S&N:<br />
72203583, 72203584 and 72203585, respectively) to conveniently prepare the membranes.<br />
1. Using the BD Micro-fine drawing syringe, draw the necessary PRGF® Activator volume in the ratio of 0.05 ml (5 units in the<br />
BD Micro-fine syringe scale) of PRGF® Activator per milliliter of plasma.<br />
Note: Be aware that the BD Micro-fine drawing syringe is labeled in UNITS, not milliliters. Conversion is critical to prevent<br />
errors.<br />
page 7 of 44
Change language