INSTRUCTIONS FOR USE SECTION.

BLOOD COLLECTION INSTRUCTIONS FOR SYSTEMS CONTAINING Y SAMPLING SITE (YSS) ONLY. 1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturers instructions.2. Clamp donor tubing between DonorCare Needle Guard (DCNG) and Sampling Site.3. Secure donor tubing above the connector and disinfect site of phlebotomy.4. If using blood pressure cuff, inflate to not more than 60 mm Hg.5. Remove donor needle cover and accomplish phlebotomy.6. Release clamp and ensure there is blood flow. Reduce pressure as required.7. Slide the DCNG midway over the needle hub and securely tape DCNG to the donors arm as close to the top of the DCNG as possible. Note: If blood flow is slow, slide DCNG away from the needle hub, adjust and re-engage DCNG. If repeated needle adjustment is necessary, slide DCNG away from the needle hub and re-engage at the end of blood collection.8. Collect appropriate volume of blood into collection bag, as indicated on packaging. Note: Mix blood and anticoagulant frequently during collection, for example, once every 45 seconds, and immediately after collection. If blood agitation device is used, follow manufacturers operating instructions.9. After required amount of blood has been collected, seal donor tubing close to Sampling Site.10. For blood sampling, remove the Sampling Site needle cover. Ensure the protective sheath is in place over the sampling needle.11. Fasten the vacuum tube holder on to the base of the sampling needle.12. Collect blood samples into vacuum tubes.13. Ensure the vacuum tubes are centered within the vacuum tube holder during sample collection.14. Maintain forward pressure on the vacuum tubes during sample collection. Note: After the last tube is collected, it is recommended that the vacuum tube holder be left in place.15. After blood samples are collected, clamp donor tubing between the Sampling Site and DCNG, and as close to the DCNG as possible.16. Release any remaining pressure from the donors arm.17. DCNG must be held stationary while the needle is withdrawn into it. While holding sides of DCNG near the front, grasp the tubing below the clamp and pull the needle into the DCNG until it locks into place, and the needle hub engages the bottom of the DCNG.18. Insert the DCNG into the vacuum tube holder. Note: It is recommended that the DCNG be inserted securely into the vacuum tube holder, prior to discarding.19. Seal donor tubing adjacent to DCNG. Detach and discard needle, DCNG, Sampling Site and tubing.20. Strip tubing between seal and collection bag.21. Continue to Processing Instructions, Step 1.

INTENDED USE OF THE DEVICE.

PROCESSING INSTRUCTIONS. 1. Process whole blood within 72 hours of collection.2. Mix whole blood/anticoagulant thoroughly.3. Load whole blood and satellite bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup.4. Centrifuge at appropriate conditions to produce desired components.5. Carefully remove the unit from the centrifuge and place the red cell storage bag in the plasma expressor.6. Clamp tubing to extra satellite bags, if present.7. Gently apply expressor pressure.8. Open snap-open closure to satellite bag and express plasma.9. After plasma is expressed, clamp tubing between red cell storage bag and connector, and release expressor pressure.10. Clamp tubing between the connector and plasma bag.11. Hang AS-3 bag above red cell storage bag and remove clamp from tubing to the red cell storage bag.12. Open snap-open closure on the bag containing the AS-3 additive solution and transfer to the bag containing the red cells. Note: AS-3 solution should be added to the packed red blood cells immediately after removal of plasma. Transfer AS-3 solution under one of the following processing conditions:a. within hours of collection if whole blood is held at room temperature.b. within 72 hours of collection if whole blood is refrigerated.13. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.14. Gently mix packed red cells and AS-3 solution.15. Store CP2D/AS-3 preserved red blood cells at 1--6 for up to 42 days and use as indicated. Note: If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1--6 for up to 21 days.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

HOW SUPPLIED. Each shipping case contains foil envelopes. Within each foil envelope resides clear pouches containing an individual collection system. Each collection system consists of CP2D/AS-3 500 ml, Double Blood Bag Collection System with Nutricel Additive Solution and Sample Diversion Pouch.Collection Bag Label. CP2D 500 ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTIONAS-3 RED BLOOD CELLS, ADENINE SALINE ADDED, 16.5 mEq sodium added.From 500 ml CP2D Whole Blood. Store at 1--6 C.70 ml Anticoagulant Citrate Phosphate Double Dextrose Solution for collection of 500 ml of blood. Each 70 ml of CP2D solution contains 3.57 dextrose (monohydrate), USP; 1.84 sodium citrate (dihydrate), USP; 0.229 citric acid (monohydrate), USP; and 0.155 monobasic sodium phosphate (monohydrate), USP. Use only if solution is clear.See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only. PROPERLY IDENTIFY INTENDED RECIPIENT.120-92Plasma Bag Label. CP2D 500See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only. PROPERLY IDENTIFY INTENDED RECIPIENT.120-92Additive Bag LabelAS-3 ADDITIVE SOLUTION110 mL of preservative AS-3 contains: 1.21 Dextrose (monohydrate), USP; 0.647 Sodium Citrate (dihydrate), USP; 0.451 Sodium Chloride, USP; 0.304 Monobasic Sodium Phosphate (monohydrate), USP; 0.046 Citric Acid (monohydrate), USP; 0.033 Adenine. Contains 16.5 mEq of Sodium. Use only if solution is clear. Do Not Store Any Blood Components In This Bag. Discard Bag After Using. See Direction Sheet.14-3127-120Envelope LabelCP2D/AS-3 500 ml Double BLOOD COLLECTION SYSTEM with Nutricel Additive Solution with Sample Diversion PouchFor collection of 500 ml of blood and preparation of red blood cells and plasma.Each unit consists of collection bag with 70 ml of CP2D solution, an additive bag with 110 ml of AS-3 solution, and one empty bag. Each 70 ml of CP2D solution contains 3.57 dextrose (monohydrate), USP; 1.84 sodium citrate (dihydrate), USP; 0.229 citric acid (monohydrate), USP; and 0.155 monobasic sodium phosphate (monohydrate), USP. Each 110 ml of AS-3 solution contains 1.21 dextrose (monohydrate), USP; 0.647 sodium citrate (dihydrate), USP; 0.451 sodium chloride, USP; 0.304 monobasic sodium phosphate (monohydrate), USP; 0.046 citric acid (monohydrate), USP; and 0.033 adenine, USP. Sterile, nonpyrogenic fluid path. Sterilized by steam. See accompanying directions for use. Rx only. Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and SECURING open end of pouch to prevent possible loss of moisture.120-92. Collection Plasma Additive Envelope.

PRECAUTIONS SECTION.

GENERAL PRECAUTIONS. Use aseptic technique. Use only if solutions are clear. If preparing platelet concentrate, the platelet-rich plasma should be separated from the red blood cells within hours after blood collection. If preparing fresh frozen plasma, separate from the red blood cells and place in the freezer at -18 or colder within hours after collection. During processing, always observe the following precautions:1. Sealing should be done in manner that avoids fluid splatter.2. Always dispose of blood-contaminated products in manner consistent with established BIOHAZARD safety procedures.