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Table of Contents
Related Manuals for HemoCue Albumin 201
Summary of Contents for HemoCue Albumin 201
- Page 1 ® HemoCue Albumin 201 Operating Manual...
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Page 2: Table Of Contents
Table of Contents Intended use ...............3 Components ..............4 Start up .................6 Set-up Printer function ..........8 Specimen Collection ..........10 Measurement ............12 Maintenance .............18 Turbidity scale ............20 Troubleshooting Guide ...........22 Specifications ............30 Warranty and service ..........32... -
Page 3: Intended Use
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. -
Page 4: Components
Components... - Page 5 1. The 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 6. HemoCue Cleaner. The HemoCue Albumin 201 Analyzer and a power adapter are delivered in a carton.
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Page 6: Start Up
Start-up... - Page 7 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.
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Page 8: Set-Up Printer Function
Set-up Printer function... - Page 9 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 informa- tion. *Not included. The following comport settings are used: • Baudrite 9600 •...
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Page 10: Specimen Collection
Specimen collection U-Albumin – Spot urine, morning urine... - Page 11 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 instru- ment in mg/L.
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Page 12: Measurement
Measurement... - Page 13 Open the microcuvette package and carefully remove the cuvette. Pipette a drop of urine onto a hydropho- bic surface (for example, Parafilm). It is also possible to fill the cuvette direct- ly from the sample, if it is not to be used for any other analysis.
- Page 14 Measurement...
- Page 15 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).
- Page 16 Measurement...
- Page 17 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 pres- ent in the cuvette in extremely low quantities, consult local environmental authorities for proper disposal.Always handle urine with care, as it might be...
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Page 18: Maintenance
Maintenance... - Page 19 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.
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Page 20: Turbidity Scale
Turbidity scale... - Page 21 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 sepa- rated, do not proceed with the analysis.
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Page 22: Troubleshooting Guide
1. Unstable blank value. The instrument may be 1a. Check that the instrument and cuvettes are being too cold. used according to the HemoCue Albumin 201 system Operating Manual and instructions for use. 1b. The instrument needs service. Contact HemoCue America. - Page 23 The absorbance is too high. 1a. Check that the instrument and cuvettes are being 1. Light blocking item in the cuvette holder. used according to the HemoCue Albumin 201 system Operating Manual and instructions for use. 1b. The instrument needs service. Contact HemoCue America.
- Page 24 Symptom Explanation Action 1. The stepper motor causing the cuvette holder to 1. The instrument needs service. Contact HemoCue America. vibrate is out of order. 2. Check that the power adapter is recommended by 2. Wrong power adapter is used.
- Page 25 6b. The control is beyond its expiration date or has 6a. If a quality control test is to be performed, only use controls been stored incorrectly. recommended by HemoCue, see relevant package insert for 7. Incompletely filled cuvette. more information.
- Page 26 Albumin Microcuvettes are for In Vitro diagnostic use tures between 32–122°F (0 –50 ºC). The operating tem- only. The HemoCue Albumin 201 Analyzer is only to be perature is 59 – 86°F, (15-30ºC). The analyzer should be used with HemoCue Urine Albumin Microcuvettes.
- Page 27 Measurements from spot urine during the day may give • The HemoCue Albumin 201 Analyzer has an internal slightly higher results due to physical activity. In these electronic self test. Every time the analyzer is turned on it circumstances, normal values are less than 30 mg/L will automatically perform the self test.
- Page 28 To maintain safety use only adapter marked price. For technical difficulties or repair contact HCA01 HemoCue America, Technical Support. Any other use of the system than recommended by the manufacturer will void the warranty. Efficiency Level Spare parts –...
- Page 29 Technical 250 South Kraemer Boulevard specifications. The customer or user of the HemoCue Brea, CA, 92821 Albumin 201 system should assure that it is used in such Phone(General): 800-881-1611 an environment. The HemoCue Albumin 201 system uses Orders: 800-323-1674 RF energy only for its internal function.
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Page 30: Specifications
RF communications equipment and tance for the higher frequencyrange applies. HemoCue Albumin 201 Analyzer The HemoCue systems are intended for use in an electro- NOTE 2 These guidelines may not apply in all situ- magnetic environment in which radiated RF disturbances ations. - Page 31 Guidance and manufacturer’s declaration – Electromagnetic immunity The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or user of the HemoCue systems should assure that it is used in such an environment. Immunity test...
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Page 32: Warranty And Service
3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz to 80 MHz equipment should be used no closer to any part of the HemoCue systems, Radiated RF 3V/m 3 V/m including cables, than the recommended IEC 61000-4-3 80 MHz to 2.5 GHz... - Page 33 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HemoCue systems are used exceeds the applicable RF compliance level above, the HemoCue systems should be observed to verify normal operation.
- Page 34 Serial shielded maximum 1.5 m Guidance and manufacturer´s declaration – electromagnetic emissions The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or the user of the HemoCue systems should assure that it is used in such an environment.
- Page 36 HemoCue AB | Box 1204 | SE-262 23 Ängelholm | Sweden | Phone +46 77 570 02 10 | Fax +46 77 570 02 12 info@hemocue.se | hemocue.com...