ESR-10 Manual Rack Instructions for Use March 2015

ESR-10 Manual Rack INSTRUCTIONS FOR USE INTENDED USE ESR-10 Manual Rack is a manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using Streck ESR-Vacuum Tubes. SUMMARY AND PRINCIPLES The ESR test is a common laboratory test used to indicate patient conditions such as acute tissue damage, chronic infection and chronic inflammation. The ESR test measures the rate that erythrocytes separate from human plasma and settle to the bottom of a tube of anticoagulated blood. ESR results are reported in millimeters that the plasma-erythrocyte interface falls in a designated perpendicular tube of anticoagulated whole blood per hour. ESR results become elevated due to the formation of erythrocyte rouleaux, which is caused mainly by alterations in plasma and erythrocyte factors. The ESR-10 Manual Rack is designed to accurately measure the sedimentation rate of erythrocytes in 30 minutes using 1.2 ml ESR-Vacuum Tubes. The ESR-10 Manual Rack allows the user to report the result obtained directly from the measuring scale supplied with the rack. Results are reported as millimeters per hour (mm/hr) Modified Westergren Method by using the QuickMode conversion for measuring ESR in only 30 minutes. There may be situations where the sample cannot be analyzed immediately after it is drawn and must be transported or preserved for future analysis. ESR-Vacuum Tubes preserve the integrity of the patient sample for sed rate analysis until processing and testing can be performed. Samples can be maintained from the time of blood collection for up to 72 hours prior to analysis when transported and stored at 2 ºC-10 ºC, or up to 4 hours at 18 ºC-30 ºC. PRECAUTIONS 1. For In Vitro Diagnostic Use. 2. All patient blood samples should be treated as if they are capable of transmitting infections and should be handled with appropriate precautions. Avoid contact with skin and mucous membranes. 3. Used tubes containing blood should not be disposed of in general waste, but should be disposed with infectious medical waste. 4. The ESR test is sensitive to temperature, tube angle and vibration. It is important to place the stand on a level surface where there is no draft. Avoid placing the test rack next to windows, centrifuges, air vents, etc. 5. Do not adjust the position of the tube in the rack by pulling on the stopper. 6. This product is intended for use as supplied. Adulteration of any materials to the product as supplied invalidates any diagnostic use of the product. STORAGE AND STABILITY The ESR-10 Manual Rack may be stored at 2 ºC-30 ºC. INDICATION OF PRODUCT DETERIORATION 1. Inability to obtain expected ESR results may indicate product deterioration. 2. Repeat the ESR test to confirm erroneous results; if the same result is obtained, contact Streck Technical Services at 800-843-0912 or [email protected]. INSTRUCTIONS FOR USE Rack Installation 1. Insert the three adjustable leveling feet supplied with the rack into the predrilled holes on the bottom of the rack. 2. Place the rack on a level surface that is free from vibration and temperature fluctuation. Avoid placing the rack in areas that receive direct sunlight or are in close proximity to air vents from heating/cooling systems. 3. Adjust the rack to level by turning the adjustable leveling feet until the bubble in the circular spirit level is centered in the circle printed on the top of the level. 4. Insert the measuring scale supplied with the rack into the slot on the front face of the rack with the printed side facing forward. Sample Preparation 1. Obtain a nonhemolyzed blood specimen and warm to room temperature (18 ºC-30 ºC) for at least 15 minutes prior to analysis. Blood specimens may be drawn in or transferred into a Streck ESR-Vacuum Tube. Refer to tube IFU. 2. Verify the specimen is well-mixed and free from clots. NOTE: The mixing process prior to evaluation of an ESR sample is critical. A well-sedimented sample may require several minutes of mixing prior to testing. The optional ESR-657 Mixer uses a full 360° rotation on a slow cycle to mix samples and accommodates up to 10 ESR-Vacuum Tubes. 3. Each tube position is marked with red circle numbered one through 10. Place the ESR-Vacuum Tube in any free position with the stopper in the upright position. 4. Align the tube so that the bottom of the liquid meniscus is in line with the zero position on the measuring scale. NOTE: Do not adjust the position of the tube in the rack by pulling on the stopper. 5. Allow the sample to settle in an undisturbed, vertical position for 30 minutes. 6. At 30 ± 1 minute, record the numerical value at the top of the column of sedimented erythrocytes. Read the bottom of the meniscus at eye level. Report the result as mm/hr Modified Westergren method. LIMITATIONS 1. ESR-10 Manual Rack is to be used for Erythrocyte Sedimentation Rate testing only. It is not intended for performing other hematology sample analysis. 2. Tube angle, vibration and fluctuations in temperature may adversely affect the accuracy of ESR results obtained with the ESR-10 Manual Rack. 3. The reportable range of the ESR-10 Manual Rack is 0-100 mm/hr. EXPECTED RESULTS Results obtained from fresh whole blood specimens collected properly in a 1.2 ml ESR-Vacuum Tube and tested on an ESR-10 Manual Rack will correlate with the Modified Westergren method. ORDERING INFORMATION Please call our Customer Service Department toll free at 800-228-6090 for assistance. Additional information can be found online at www.streck.com.

GLOSSARY OF HARMONIZED SYMBOLS EC REP

LOT

REF

Authorized Representative in the European Community

Batch Code

Biological Risk

Catalog Number

Manufacturer

Consult Instructions For Use

Temperature Limitation

Use By

IVD In Vitro Diagnostic Medical Device

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350507-4 2015-03