Intended  Use  of  the  Device

This device is used for the separation of autologous platelet rich plasma (PRP) and other plasma-derived products.

Indications for Use

All models of platelet rich tubes are designed to be used for the safe and rapid preparation of autologous PRP from a small volume of blood.

Contraindications

It is recommended that a patient should not receive PRP when they have:

• Cancer or metastatic disease
• An active infection
• A low platelet count
• Pregnant or breastfeeding

Warnings and Precautions

• FOR SINGLE USE ONLY
• Use PRP only on the same patient from whom the blood was drawn
• Autologous PRP must be prepared from fresh blood and used within four hours
• Use appropriate safety precautions to protect yourself from needles and blood products. Samples of blood should be regarded as potentially infectious
• Discard the entire kit after single use. Do not reuse. The product should be discarded and treated as a potentially infectious blood product. The product should be discarded into biological hazard container.
• Do not use if the packing is damaged or open. Do not re-sterilize
• Do not use product if foreign matter is present in the tube
• Storage above 400C may damage the gel stability
• Storage of tubes with blood at or below 00C may result in tube breakage

• Do not under-fill tubes with blood as an incorrect blood to additive ratio may result in poor product performance

• Follow the manufacturer's instructions when using the centrifuge
• Do not use excessive centrifugation as it may result in breakage of the tube. Use centrifuge as recommended in the instructions.
• Do not use after the expiration date

Possible adverse events

• Temporary or permanent nerve damage that may result in pain or numbness
• Damage to blood vessels/hematomas 
• Infection

Storage and stability

• Store at room temperature 5 - 300C
• Do not expose to sunlight
• Do not use if the sterile package is damaged.
• Do not use after expiration date

Instructions for Use

Important: Use standard aseptic technique throughout the following procedure.

1. Open the blister pack and remove a Next MD Platelet Rich Plasma 22mL tube
2. Draw blood from the patient using standard venous puncture procedures and fill the PRP vacuum tube with whole blood. The vacuum should automatically collect the correct amount of whole blood. A 21G butterfly needle is recommended.
3. Invert the tube several times to ensure the anticoagulant is mixed with the blood.
4. Place the tube into the centrifuge. Always ensure the centrifuge is correctly balanced before beginning the centrifuge (counterbalance with an equal size PRP tube filled with water)
5. Centrifuge at 1500 g (RFC) for 12 minutes
6. After centrifugation, the red blood cells and most of the white blood cells will be below the plug of gel.
7. Gently invert the Next MD PRP tube several times to re-suspend the platelets in the plasma . Approximately, 10 - 12 ml of plasma will be available.
8. Withdraw the PRP with a sterile syringe and needle, the PRP is now ready for use. 
9. Alternatively, if you wish to concentrate the platelets in a smaller volume of plasma. Prior to inverting and re-suspending the platelets gently remove the top half of the plasma (the platelet poor plasma). Then gently invert the PRP tube several times to re-suspend the concentrated platelets in the remaining plasma.