Albumin 201 Operating Manual July 2014

HemoCue® Albumin 201 system Operating Manual

US

The HemoCue® Albumin 201 system consists of the HemoCue Albumin 201 Analyzer and HemoCue Urine Albumin Microcuvettes. The system provides rapid, simple and reliable quantitative determination of albumin in urine with results that are precise and accurate. The system can be used for the purpose of screening, for diagnosis, monitoring and supporting the clinical evidence in the treatment of microalbuminuria. This manual provides the basic instructions for routine use as well as technical specifications. Additional information may be obtained from HemoCue America. The HemoCue Albumin 201 System is classified as Waived under the CLIA Guidelines and can be used by all laboratories holding a CLIA certificate of waiver. Please note that the complete test procedure should be read before performing the test. If the laboratory modifies the HemoCue Albumin 201 test procedure, the test no longer meets the requirements for waived categorization. A modified test is considered to be highly complex and is subject to all applicable CLIA requirements. For information on how to obtain a CLIA Waiver certificate, please refer to CMS CLIA program. !

All system components are designed and manufactured to provide maximum safety. Any other use of the system may impair the safety.

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Components

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US 1. T  he HemoCue Albumin 201 Analyzer*. 2. Power Adapter**. 3. Device for removing the cuvette holder. 4. HemoCue Urine Albumin Microcuvettes***. 5. HemoCue Albumin 201 Operating Manual, Quick Reference Guide and Instruction CD. 6. HemoCue Cleaner. The HemoCue Albumin 201 Analyzer and a power adapter are delivered in a carton. Open the carton on a stable surface and lift out the analyzer and the accessories.

* Do not open the cover of the analyzer. Note: The warranty will be voided if the cover of the analyzer has been opened. ** Only use adapters, as listed under specifications. *** Not included. For infomation about HemoCue Urine Albumin Microcuvettes please contact HemoCue America.

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Start-up

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US 1. A  ttach the power adapter to the ”POWER INLET” at the back of the analyzer. Make sure that the lid on top of the analyzer is closed. 2. a. Serial port. The analyzer can be connected to a printer (for further information, see Set up Printer function). 2. b. USB port. (Used for PC-connection – only outside US) 3. Press and hold the left button until the display is activated (all symbols appear on the display). The display shows the version number of the program, audio signal and the HemoCue symbol. During this time the analyzer will automatically verify the performance of the optical unit. 4. After this the display will show three flashing dashes. This indicates that the HemoCue Albumin 201 Analyzer is ready for use. To turn the analyzer off, press and hold the left button until the display reads OFF and then goes blank. Disconnect the analyzer from the power source by removing the power adapter from the outlet. Note! Make sure that the lid is closed. If the lid is open for more than one minute, the display will show ”U-A”. Once the lid is closed, the analyzer will perform an electronic “self test”.

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Set-up Printer function 3

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US The analyzer can be on or off when connecting the printer to the analyzer. A printer can be used to print out the current result immediately after completion of the measurement. Previously obtained results cannot be printed. 1.  Connect the cable* to the analyzer and printer*. 2.  Perform the analysis by following the steps 1-6 in Measurement. 3.  When the result is shown on the display, the printer will automatically print the result. Note! Only use ASCII printers. Contact HemoCue America for information. *Not included. The following comport settings are used: • Baudrite 9600 • Databits 8 • Parity None • Stopbits 1 • Flowcontrol None

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Specimen collection U-Albumin – Spot urine, morning urine

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US Specimen collection Spot urine, preferably the first morning urine may be used. Specimen collection for U-Albumin, spot urine Collect the first morning urine. The analysis is performed as described below. The result is read directly from the instrument in mg/L.

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Measurement

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US Open the microcuvette package and carefully remove the cuvette. Pipette a drop of urine onto a hydrophobic surface (for example, Parafilm). It is also possible to fill the cuvette directly from the sample, if it is not to be used for any other analysis. 1.  Hold the cuvette opposite the filling end. The filling end is brought into contact with the urine sample. Allow the cavity of the cuvette to fill completely in one step. Do NOT refill the cuvette! Always avoid contamination of the outside of the cuvette. When completely filled, carefully 2.  wipe off the excess urine from the outside of the cuvette with a clean lint free wipe. Make sure that no sample is drawn out of the cuvette during this procedure. The filled cuvette should be visually inspected to check that the cuvette is properly filled, i.e. completely filled up to the edge and without air bubbles in the optical eye. If air bubbles are seen in the optical eye of a filled cuvette, discard the cuvette and fill another cuvette from a second drop of specimen.

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Measurement

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US 3.  Open the lid and place the filled cuvette into the cuvette holder (3a). It is important that the cuvette “snaps” properly into the cuvette holder (3b). Start measurement as soon as possible but no later than 30 seconds after filling the microcuvette by gently closing the lid (3c). 4.  During measurement the hour glass 6 is displayed with three fixed dashes. 5. Within 90 seconds, the result is displayed in mg/L. The result will remain on the display until the lid is opened. Measurements below 7 mg/L are displayed as “LLL”. Measurements above 150 mg/L are displayed as “HHH”. If the display shows an error code, an error has occurred. See the Troubleshooting Guide. Do not remeasure the cuvette. Note that the measurement is not completed until the steps in paragraph 8 have been performed and the display shows three flashing dashes.

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Measurement

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US 6. a, b, c. Open the lid and discard the cuvette. Close the lid and wait until three flashing dashes are shown in the display. 7. Although the reagents are present in the cuvette in extremely low quantities, consult local environmental authorities for proper disposal.Always handle urine with care, as it might be infectious. When the measurements for the day have been completed, switch off the analyzer with the ON/OFF button.

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Maintenance

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US The cuvette holder should be cleaned after each day of use. The cover glasses of the optical unit should be cleaned when directed to do so in the Troubleshooting Guide. Make sure that the analyzer is switched off and that the display is blank. Open the lid. 1. The cuvette holder is released by pressing the area marked with arrows using the device included with the system. 2. Press the tab downwards and draw the cuvette holder towards you until it becomes detached. Use a mild detergent or alcohol to clean the cuvette holder. 3. The cover glasses of the optical unit, both beneath and above the cuvette holder area, may be cleaned using the HemoCue Cleaner*. If a HemoCue Cleaner is not available, a cotton tipped swab moistured with water or alcohol without additives may be used. 4. Wait 15 minutes before replacing the cuvette holder. Use alcohol or mild soap detergent for cleaning the outer surface of the instrument. * One HemoCue Cleaner is included with the analyzer. Contact HemoCue America to order more.

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Turbidity scale

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US The turbidity scale provides guidance as to whether or not the sample may be used for analysis. –  Hold the turbidity scale directly behind the sample. If the stripes are well separated, –  proceed with the analysis. –  If the stripes are not well separated, do not proceed with the analysis. Note! This scale should serve only as a guide – if there is any doubt, do not proceed with the analysis.

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