Precaution: Do not use unless anticoagulant is clear. Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers. Adjust donor scale to desired collection weight. Position primary container on the donor scale as far as possible below donor arm and clamp donor tubing with hemostat. If blood pressure cuff is used, inflate to approximately 60 mmHg.
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Instructions for Use Use aseptic technique Note: Nominal tubing dimensions of product are 0. Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.
Identify Blood-Pack unit using appropriate donor identification system. Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm. Clamp donor tubing between Fenwal HighFlo1 needle and primary container.
This step may be performed prior to step 1 or 2. Remove needle cover per instructions below: a Holding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal.
When good blood flow is established, stabilize the front of the needle guard to arm with tape. Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection.
Collect the appropriate volume based on Blood-Pack unit used. Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.
To avoid possible contamination of the whole blood unit, before filling whole blood sample tubes, hermetically seal the donor tubing near the Y-Sampling Site on the side leading to the primary container using a metal clip or appropriate alternate method. Precaution: Complete steps 12 - 20 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing. To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated see Figure 2.
Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer. Open the cap on the access device if applicable. Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device until the stopper is punctured. Allow vacuum sample tube to fill with blood then remove from the access device. Repeat steps 14 and 15 until the desired number of vacuum sample tubes have been filled.
Then, grasp base of Sampling Site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove clamp and continue sampling.
Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately. If desired, apply clamp to donor tubing between needle and Y-Sampling Site.
Withdrawal of Needle see Figure 3 Precaution: The needle guard must be held stationary while the needle is withdrawn into it. Pull the hub back smoothly until the needle is completely enclosed and securely locked into the needle guard.
Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.
Note: Step 21 may be performed prior to step 20 if desired. Remove and discard the Y-Sampling Site and the needle into an appropriate biohazardous waste container following established procedures. Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations.
United States Pharmacopeial Convention, Inc.
Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex. Warnings Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours. Use only if solution is clear.
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