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HemoCue Glucose 201, Operating Manual

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HemoCue Glucose 201 with Plasma Conversion  

Operating Manual

The HemoCue

®

 Glucose 201 Analyzer with plasma conversion provides laboratory 

quality analysis of glucose in whole blood, easily, quickly and conveniently. 

Utilization of a conversion factor allows the measured whole blood result to be 

displayed as a plasma equivalent glucose value. Capillary, venous or arterial 

whole blood may be used. This manual provides the basic instruc-

tions for routine use as well as technical specifications. Further  

information may be obtained from HemoCue America or your 

local distributor.

   

All system components are designed and manufactured to provide 

 

maximum safety. Any other use of the system may impair the safety.

Summary of Contents for Glucose 201

Page 1: ...HemoCue Glucose 201 with Plasma Conversion Operating Manual ...

Page 2: ...ue Glucose 201 system 3 Components 4 Start up 6 Audio signal 8 Determination 10 Capillary blood 10 Venous and arterial blood 18 Maintenance 20 Daily maintenance 20 Optical parts 22 Troubleshooting Guide 24 Specifications 27 US ...

Page 3: ...llows the measured whole blood result to be displayed as a plasma equivalent glucose value Capillary venous or arterial whole blood may be used This manual provides the basic instruc tions for routine use as well as technical specifications Further information may be obtained from HemoCue America or your local distributor All system components are designed and manufactured to provide maximum safet...

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

Page 5: ...ick Reference Guide 6 HemoCue Cleaner The HemoCue Glucose 201 Analyzer and power adapter are delivered in a carton Open the carton on a stable surface and lift out the analyzer and the accessories Consult local environmental authorities for proper disposal of batteries Do not open the cover of the analyzer Note The warranty is voided if the analyzer has been opened Only use adapters as listed unde...

Page 6: ...6 Start up 1a 2 3 4 5 1b ...

Page 7: ...he on off button until the display is activated 4 The display shows SELFTEST and the version number of the program after which it will say GLU During the SELFTEST the analyzer will automatically verify the performance of the optronic unit 5 After 15 seconds the display will show READY and three flashing dashes This indicates that the HemoCue Glucose 201 Analyzer is ready for use To turn the analyz...

Page 8: ...8 1 2a 2b 3 Audio signal ...

Page 9: ...older out to the loading position 2a b Press and hold the on off button until the display shows a bell in the upper right corner The audio signal is now activated 3 Wait until the analyzer display says READY before performing an analysis To turn off the audio signal follow steps 1 3 until the bell in the upper right corner disappears The analyzer is delivered with the audio signal turned off US ...

Page 10: ...10 Measuring Capillary blood 1 2 3 4 ...

Page 11: ...te holder should be in the loading position The display will show READY and three flashing dashes 2 Make sure the patient s hand is warm and relaxed Use only the middle or ring finger for sampling Avoid fingers with rings on 3 Clean with disinfectant and allow to dry or wipe off with a dry lint free tissue 4 Using your thumb lightly press the finger from the top knuckle towards the tip This stimul...

Page 12: ...12 8 7 6 5 ...

Page 13: ...e of the fingertip not in the center 6 While applying light pressure towards the fingertip puncture the finger using the lancet 7 Wipe away the first 2 or 3 drops of blood 8 Re apply light pressure towards the fingertip until another drop of blood appears US ...

Page 14: ...14 9 10 11 ...

Page 15: ...ee tissue being careful not to touch the open end of the microcuvette 11 Look for air bubbles in the filled microcuvette If present take a new sample Small bubbles around the edge can be ignored Note If a second sample is to be taken from the same fingerstick it is important that this should be done after the first sample has been read Wipe away the remains of the first sample and take a second on...

Page 16: ...16 14 15 12 14 13 ...

Page 17: ...ed The result will remain on the display as long as the cuvette holder is in the mesuring position When operating on battery power the analyzer will automatically turn off after approximately 10 minutes The result can be retrieved by pressing the on off button until the display is reactivated DO NOT remeasure the microcuvette 15 Although the reagents are present in the microcuvette in extremely lo...

Page 18: ...18 3 1 2a 2b 4 Measuring Venous and arterial blood ...

Page 19: ...ocuvette in one continuous process The microcuvette shall be completely filled Do NOT refill Wipe off excess blood from the outer surface of the microcuvette with lint free tissue being careful not to touch the open end of the microcuvette 4 Look for air bubbles in the filled microcuvette If present take a new sample Small bubbles around the edge can be ignored Perform the analysis as per steps 12...

Page 20: ...20 2 3 4 Maintenance Daily maintenance 1 ...

Page 21: ...to the left 3 Remove the cuvette holder from the analyzer it will come off the stainless steel pin it rotates on 4 Clean the cuvette holder with alcohol 20 70 or mild detergent Wait 15 minutes before replacing the cuvette holder and using the analyzer Make sure the cuvette holder is dry before inserting The optical parts should be cleaned when directed to do so in the Troubleshooting Guide see Mai...

Page 22: ...22 5b 5c Maintenance Optical parts 5a 6 ...

Page 23: ...left see picture 5c If the Cleaner is stained repeat with a new Cleaner 6 Wait 15 minutes before replacing the cuvette holder and using the analyzer Make sure the cuvette holder is dry before inserting The cover may be cleaned with alcohol 20 70 or mild detergent Note As an alternative to the HemoCue Cleaner a lint free cotton swab non pretreated moistened with alcohol 20 70 without additive or wa...

Page 24: ...uring LED is too low 1 The optronic unit is dirty 2 The optronic unit is out of order 902 1 Clean the optronic unit as described in the Maintenance section 2 The analyzer needs service Call your distributor 1 The optronic unit is out of order 903 1 The analyzer needs service Call your distributor 1 Light intensity for one of the LED s is too high 905 1 The analyzer needs service Call your distribu...

Page 25: ...30 1a Turn off the analyzer and allow it to reach room temperature 1b If the problem continues the analyzer needs service Call your distributor 1 Measured value exceeds 444 mg dL 24 6 mmol L HHH 1 Check the expiration date of the microcuvettes 2 Remeasure sample with fresh microcuvette 1 The analyzer is not receiving power 2 If on battery power the batteries need to be replaced 3 The display is ou...

Page 26: ...rol materials out of range either too HIGH or too LOW 1 Check the expiration date and the storage conditions of the microcuvettes 2 Remeasure the sample with a new microcuvette 3 Make sure that the control is mixed well and at room temperature 4 Check the microcuvette for air bubbles Remeasure the sample with a new microcuvette 5 Clean the optronic unit as described in the Maintenance section 6 On...

Page 27: ...tes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer For professional use only Theory The chemistry method utilized by the HemoCue Glucose 201 Microcuvette is a modified glucose dehydrogenase method described by Banauch et al 3 A chromogen compound is added to the reagents according to the principle outlined by Bergmeyer4 with saponin used for hemo...

Page 28: ...testing using commercially available controls recommended by HemoCue Contact HemoCue America Technical Support for advice Results The measuring range is 0 444 mg dL 24 6 mmol L Results above 444 mg dL 24 6 mmol L will be displayed as HHH and should be confirmed with another laboratory method To establish HemoCue glucose reference values and an intervention level neonatal blood samples should be ev...

Page 29: ...e instrument is made for continous mode AC Adapters Adaptor HemoCue HCA01 or Friwo FW7333 SM12 can also be used input 100V 240V 50 60 Hz 200mA 500mA HCA01 Essential Performance The essential performance is quantitative determination of glu cose in capillary venous or arterial whole blood Warranty The analyzer carries a 24 month warranty from the day of receipt After the warranty period service rep...

Page 30: ...er 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 appli cable to the frequ...

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 differential mode Mains power quality should be that of a typical commercial or hospital environ ment Voltage dips short inter ruptions and voltage varia tions 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: ...nce 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 ac cording to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmit ters as determi...

Page 33: ...ile 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 conside red 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...

Page 34: ... RF emissions 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 es tablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctu...

Page 35: ...C Vol 12 No 4 http www ifcc org ejifcc vol12no4 vol12no4a4 htm 3 Banauch et al Z Klin Chem u Klin Biochem 1975 13 101 107 4 Bergmeyer Methods of Enzymatic Analysis 1 1974 Chemie Publishers Weinheim 5 Burtis CA Ashwood ER Tietz Fundamentals of Clinical Chemistry 5th ed Saunders Philadelphia 2001 447 6 Definition Diagnosis and Classification of Diabetes Mellitus and its Complications Report of a WHO...

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