1\. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturer's instructions.

2\. Clamp donor tubing between DonorCare Needle Guard (DCNG) and Sampling Site.

3\. Secure donor tubing above the Y 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.

7\. Slide the DCNG midway over the needle hub and securely tape DCNG to the donor's 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\. The donor blood will be automatically diverted to the sample diversion pouch. Once the sample diversion pouch is filled, close clamp immediately on tubing between the sample diversion pouch and Y connector. Warning: To avoid risk of air embolism to donor, do not squeeze sample diversion pouch while tubing is open.

9\. Open snap-open closure between the Y connector and the collection bag to initiate blood collection. Reduce pressure as needed.

10\. Permanently seal tubing between the sample diversion pouch and the Y connector to maintain sterility of the system prior to collecting blood samples.* Note: When using systems with a pre-attached SampLok vacuum tube holder, go to “When Using Systems with a Pre-attached SampLok Vacuum Tube Holder”.

11\. For blood sampling, remove the Sampling Site needle cover. Ensure the protective sheath is in place over the sampling needle.

12\. Fasten the vacuum tube holder on to the base of the sampling needle.

13\. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis.

14\. Collect blood samples from the sample diversion pouch into vacuum tubes within approximately four minutes to avoid possible clot formation.

15\. Ensure the vacuum tubes are centered within the vacuum tube holder during sample collection.

16\. 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.

17\. 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 manufacturer's operating instructions.

18\. After required amount of blood has been collected, seal donor tubing close to snap-open closure.*

19\. Clamp donor tubing between the Y connector and DCNG, as close as possible to the DCNG.

20\. Release any remaining pressure from donor's arm.

21\. 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.

22\. Insert the DCNG into the vacuum tube holder, if desired. Note: It is recommended that the DCNG be inserted securely into the vacuum tube holder, prior to discarding.

23\. Seal donor tubing adjacent to DCNG.* Detach and discard needle, DCNG, sample diversion pouch and tubing.*

24\. Strip tubing between seal and collection bag.

25\. Continue to “Processing Instructions”, Step 1.