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HemoCue

®

Albumin 201

Operating Manual

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Summary of Contents for Albumin 201

Page 1: ...HemoCue Albumin 201 Operating Manual ...

Page 2: ...ontents 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: ...onal 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 requiremen...

Page 4: ...4 Components 1 2 4 3 5 6 ...

Page 5: ... The HemoCue Albumin 201 Analyzer and a power adapter are delivered in a carton Open the car ton 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 pl...

Page 6: ...6 Start up 1 2a 3 4 2b ...

Page 7: ...rogram 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 p...

Page 8: ...8 Set up Printer function 1 3 ...

Page 9: ...nnot 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 informa tion Not included The following comport settings are used Baudrite 9600 Databits 8 Parity None Stopbits 1 Flowcontro...

Page 10: ...10 Specimen collection U Albumin Spot urine morning urine ...

Page 11: ...ine 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 US ...

Page 12: ...12 Measurement 1 2 ...

Page 13: ...y in one step Do NOT refill the cuvette Always avoid con tamination of the outside of the cuvette 2 When completely filled carefully 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 proce dure The filled cuvette should be visually inspected to check that the cuvette is properly filled i e complete...

Page 14: ...14 Measurement 3a 3b 3c 4 5 ...

Page 15: ... 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...

Page 16: ...6b 16 Measurement 6a 6c ...

Page 17: ... 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 infectious When the measurements for the day have been completed switch off the analyzer with the ON OFF button US ...

Page 18: ...18 Maintenance 1 2 3 4 ...

Page 19: ... 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 rep...

Page 20: ...Turbidity scale 20 ...

Page 21: ...sis 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 Note This scale should serve only as a guide if there is any doubt do not proceed with the analysis US 21 ...

Page 22: ...tion 3 The instrument needs service Contact HemoCue America 4 Check that the power adapter is recommended by HemoCue E03 1 Disturbance on the AC power supply 2 The optical unit is out of order 1 Use a different wall outlet 2 The instrument needs service Contact HemoCue America E04 1 The dark current measured on the detector is too low 1 The instrument needs service Contact HemoCue America E05 1 Li...

Page 23: ...e America E13 1 This can be seen during use and is an error that prevents further measurements A read or write operation to the RAM did not succeed 1 The instrument needs service Contact HemoCue America E21 1 Testing a configuration area in EEPROM returned as an erroneous checksum 1 Turn off the instrument and turn it on again after 30 seconds If the problem continues the instrument needs service ...

Page 24: ...ring range HHH 1 Measuring value 150 mg L 1 The result is above the measuring range No characters in the display 1 The instrument is not receiving power 2 The display is out of order 1a Check that the power adapter is connected to the AC supply 1b Check that the the power adapter is suitable for the instru ment 1c Check that the cable to the power adapter is not damaged 1d Check that the the power...

Page 25: ...control 1 Check the expiration date and the storage conditions of the cuvettes 2 Measure the control sample with a new cuvette 3 Make sure that the control is properly mixed and that it has reached room temperature 4 Check the cuvette for air bubbles Remeasure the control sample with a new cuvette 5 Clean the optical unit as instructed under Maintenance 6a If a quality control test is to be perfor...

Page 26: ...n albumin in the sample The agglutination is enhanced by polymers The turbidity of the agglutinates once formed is mea sured photometrically at 610 nm Reagents 11 w w rabbit anti human albumin antibody poly clonal 35 w w PEG 18 w w Tris HCl buffer 2 w w polymer and 33 w w non reactive ingredients Specimen collection and preparation Collect the first voided morning urine Morning urine after rest is...

Page 27: ...ocuvettes For specific performance characteristics see the package insert for HemoCue Urine Albumin Microcuvettes Expected values According to the literature the following results are indicators for normal and pathological urine albumin results respectively U Albumin U Albumin overnight Interpretation Spot sample Urine collected morning urine overnight 20 mg L 20 µg min normal 20 200 mg L 20 200 µ...

Page 28: ...ervice or disposal Consult your local environmental authorities for proper disposal Symbols used Caution Consult instructions for use CE mark Class II equipment Only valid within the European Community Indicates separate collection for waste of elec trical and electronic equipment Temperature limitation To maintain safety use only adapter marked HCA01 Efficiency Level DC Inlet USB port Serial port...

Page 29: ...tact HemoCue America The HemoCue Albumin 201 system is intended for use in the electromagnetic environment specified in Technical specifications The customer or user of the HemoCue Albumin 201 system should assure that it is used in such an environment The HemoCue Albumin 201 system uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any in...

Page 30: ...ter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at maximum output power not listed above the recommended separation distances d in meters m can be estimated using the equation ap plicable to the freq...

Page 31: ...nput output lines Mains power quality should be that of a typical commercial or hospital environ ment Surge IEC 61000 4 5 1 kV differential mode 1 kV differenti al mode Mains power quality should be that of a typical commercial or hospital environ ment Voltage dips short in terruptions and voltage variations on power supply lines IEC 61000 4 11 5 U 95 dip in U for a 0 5 cycle 40 U 60 dip in U for ...

Page 32: ...ance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determin...

Page 33: ...le radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy 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 b...

Page 34: ...n test Compliance Electromagnetic environment guidance RF emissions Group 1 The HemoCue systems uses RF energy only for its internal function Therefore its RF emissi ons are very low and not likely to cause any interference in nearby electronic equipment RF emissions Class B The HemoCue systems are suitable for use in all establishments including domestic estab lishments and those directly connect...

Page 35: ......

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 900615 140726 US BERGSTENS HBG ...

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