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73

Repeatability

A study has been performed according to CLSI Document H26-A2 using fresh blood samples to determine repeatability at low, normal 
and high concentrations. The study was performed on venous whole blood samples tested with 31 replicates per sample using 1 analyzer 
and 1 batch of cuvettes.

N

WBC
Level

Total WBC

Neutrophils

Lymfocytes

Monocytes

Eosinophils

Mean

(x10

9/

L)

SD

(x10

9

/L)

CV

(%)

Mean

(x10

9/

L)

SD

(x10

9

/L)

CV

(%)

Mean

(x10

9

/L)

SD 

(x10

9

/L)

CV

(%)

Mean

(x10

9

/L)

SD 

(x10

9

/L)

Mean

(x10

9

/L)

SD

(x10

9

/L)

31

Low

2.8

0.14

5.0

1.5

0.11

7.3

1.0

0.08

 7.8

0.2

0.03

0.1

0.02

31

Normal

6.1

0.17

2.8

3.4

0.13

3.7

2.2

0.10

 4.6

0.3

0.07

0.1

0.03

31

High

18.1

0.57

3.1

14.4

0.61

4.3

2.8

0.26

 9.5

0.8

0.14

0.1

0.05

Summary of Contents for WBC DIFF

Page 1: ...HemoCue WBC DIFF Operating Manual ...

Page 2: ...s 12 Procedure Symbols 14 Display Symbols 15 Set Up 18 Settings 18 Printer 26 Keyboard 28 Barcode Reader 30 Connectivity 32 Blood Collection 34 Capillary Sample 34 Control Material and Venous Sample 40 Routine Use 42 Patient Test 42 QC Test 48 Review Delete Results 54 Maintenance 58 Daily Maintenance 58 Optical Parts 60 Troubleshooting Guide 62 Specifications 68 ...

Page 3: ... count and basophil count The HemoCue WBC DIFF system is indicated for use in clinical laboratories and for point of care testing in professional health care settings on pediatric 3 months and adult patients The HemoCue WBC DIFF Analyzer is only to be used with HemoCue WBC DIFF Microcu vettes for measurement of a total white blood cell count and a differential white blood cell count or with HemoCu...

Page 4: ...3 2 1 5a 7 4 6 5b 4 Components ...

Page 5: ...ating Manual 7 HemoCue Cleaner WBC Place analyzer and accessories on a rigid surface non vibrating NOTE Do not open the cover of the analyzer The warranty is void if the cover of the analyzer is opened Only WBC DIFF cuvette holder marked WBC DIFF is to be used with the WBC DIFF analyzer Not included For infomation about HemoCue WBC DIFF Microcuvettes and HemoCue WBC Microcuvettes please contact yo...

Page 6: ...1 2 3 6 Start Up ...

Page 7: ...the power inlet at the back of the analyzer Insert Batteries 2 Press the ribbed marked button on the back of the analyzer to open the battery compart ment on the left side 3 Gently take out the battery unit Insert six type C LR14 HR14 batteries 1 5 V Observe the indication of polarity Put the battery unit back in the analyzer Consult local environmental authorities for proper disposal of batteries...

Page 8: ...5 8 6 7 4 8 ...

Page 9: ...ion for approximately 15 seconds 6 The analyzer performs a self test and the hourglass is shown for approximately 30 seconds 7 The analyzer is ready for use when the main menu is shown Turn off the Analyzer 8 Press and hold the left button until the display goes blank The analyzer will automatically turn off when not in use after 5 min with battery supply after 8 hours with AC adapter ...

Page 10: ...1 2 3 10 Data Entry Navigation ...

Page 11: ...ard for data input e g Patient ID Operator ID Lab ID Control ID and Site ID It can also navigate by using F1 for left F2 for up down and F3 for right For installation of external keyboard see Set Up Keyboard section External barcode reader 3 Use the barcode reader for data input e g Patient ID Operator ID Lab ID Control ID and Site ID For installation of the external barcode reader see Set Up Barc...

Page 12: ...12 Symbols GB Navigation Symbols Designation Function Home Go to main menu Right Continue to next number window Left Return to previous number window Up Scroll up Down Scroll down ...

Page 13: ...13 Navigation Symbols Designation Function Accept Accept input Reject Reject input Switch Jump between result and data ...

Page 14: ...ion Patient Test Go to Patient Test procedure Menu Go to Menu window for Review Delete Settings QC test Review Delete Go to Review Delete menu window Review Go to Review window Delete Go to Delete Results window Settings Go to settings menu ...

Page 15: ...Function Connected Analyzer connected to a PC application Unsent Results Unsent results stored in the analyzer Accepted Accepted result Rejected Rejected result Auto Accepted Auto accepted result Battery Level Critical battery level ...

Page 16: ...tes 10 100 AC Adapter Analyzer connected with AC adapter Insert Cuvette Analyzer ready for measurement Insert a microcuvette to start measuring Remove Cuvette Pull the cuvette moving arm to laoding position and remove the cuvettte Measuring Measuring Hourglass The analyzer performs a selftest ...

Page 17: ... contain pathological abnormal or unidentified cells For more information see the Trouble shooting Guide section The print out will show an asterisk instead of the display symbol Non critical Error An error has occurred For more information see Troubleshooting Guide section Critical Error A critical error has occurred For more information see Troubleshooting Guide sec tion ...

Page 18: ...1 2 3 4 5a 5b 18 Set Up Settings ...

Page 19: ... Code is used to prevent unauthorized users from entering changing input in the settings menu As default the PIN Code is set to 0000 For change of PIN Code see step 19 Settings section Enter the PIN code by pressing the center button to change digit Press right button to confirm the input and move to the next After entering the four digit PIN Code press right button to accept and move to next wind...

Page 20: ...6 7 8 9 10 11 20 ...

Page 21: ...ht button to confirm and move forward 9 Date input window is shown Select Date input by pressing the button below the up ar row to change numbers Press right button to confirm and move to next number Press right button to confirm and move forward 10 Time Format window is shown Select Time format by pressing the button below the down arrow Press right button to confirm and move forward 11 Time inpu...

Page 22: ...12 13 14 15 16 22 ...

Page 23: ...ht button to confirm and move forward 14 Lab ID window is shown Select Lab ID on off by pressing the button below the up ar row Press right button to confirm and move forward 15 Site ID window is shown Select Site ID on off by pressing the button below the up ar row Press right button to confirm and move forward 16 Control ID window is shown Select Control ID on off by pressing the button below th...

Page 24: ...17 18 19 20 21 24 ...

Page 25: ...l is heard when a test is ready and a distinct signal is heard when an error has occured Select Audio Signal on off by pressing the button below the up arrow Press right button to confirm and move forward 19 PIN Code Setting window is shown Change digits by pressing the button below the up arrow Press right button to confirm and move to next digit Press right button to accept the four digit PIN Co...

Page 26: ...1 2a 2b 26 Set Up Printer ...

Page 27: ...Test sections 2 The result is shown on the display 2a and will be printed automatically 2b Only current result can be transferred directly to the printer Stored results can not be printed Must be purchased separately Read and follow the printer instructions for use to adjust the following COM port settings Baud rate 9600 Databits 8 Parity None Stopbits 1 Flow control None ...

Page 28: ...1 28 Set Up Keyboard ...

Page 29: ... Patient ID Operator ID Lab ID Control ID and Site ID To navigate use F1 for left F2 for up down and F3 for right 1 Connect cable from the keyboard to the USB port connection on the analyzer before performing analysis Must be purchased separately ...

Page 30: ...1 30 Set Up Barcode Reader ...

Page 31: ...ient ID Operator ID Lab ID Control ID and Site ID 1 Connect cable from the barcode reader to the USB port connection on the analyzer before performing analysis For barcode reader settings refer to barcode reader operating manual Must be purchased separately ...

Page 32: ...1 32 Set Up Connectivity 2 ...

Page 33: ...SB B connection on the ana lyzer 2 Connection via LAN Connect cable from the LAN port to the LAN connection on the analyzer The data is sent according to the POCT1 A standard For more information about the con nectivity and how to configure the IP address settings when connecting via the LAN port please contact HemoCue AB Must be purchased separately ...

Page 34: ...1 3 2 34 Blood Collection Capillary Sample ...

Page 35: ...cuvette is for single use only For measuring procedure see Routine Use Patient Test section 1 Make sure the patient s hand is warm and relaxed Use only the middle or ring finger for sampling Avoid fingers with rings on 2 Clean fingertip with disinfectant and allow to dry completely or wipe off with a dry lint free wipe 3 Using your thumb lightly press the finger from the top of the knuckle towards...

Page 36: ...4 5 6 7 36 ...

Page 37: ...ingertip puncture the finger using a lancet 6 Wipe away the first two or three drops of blood 7 Re apply light pressure towards the fingertip until another drop of blood appears In order to obtain a sufficient blood flow and representative sample high flow lancet with blade is preferred ...

Page 38: ...8 9 10 38 ...

Page 39: ...k for air bubbles in the filled microcuvette If present discard the microcuvette and fill a new microcuvette from a new drop of blood NOTE Make sure that the microcuvette is filled correctly as an improper filling angle might cause air bubbles NOTE If a second sample is to be taken it is important that this is done after the measure ment of the first sample is completed Wipe away the remains of th...

Page 40: ...1 2a 2b 3 4 5 40 Blood Collection Venous Sample and Control Material ...

Page 41: ...sing a roller mixer for 1 2 minutes or invert the tube 10 20 times by hand Samples may not be diluted For control material always follow instructions for use provided by the manufacturer 2 Place a drop of blood or control material onto a hydrophobic surface using a pipette 2a or other suitable transfer device 2b 3 Fill the microcuvette in one continuous process Do NOT refill NOTE Make sure that th...

Page 42: ...1 2 4 3 5 42 Routine Use Patient Test ...

Page 43: ...icrocuvette or HemoCue WBC Microcuvette For single packaged microcuvettes open the inner wrapping and take out the microcuvette 3 Press the button below Patient Test symbol 4 Enter required data selected in settings e g Operator ID Patient ID Lab ID and Site ID To enter data see Data Entry section 5 If data has been entered the data confirmation window is shown Press right button to confirm To cha...

Page 44: ...6 7a 7b 8 44 ...

Page 45: ...tion Venous Sample and Control Material sections Place the microcuvette into the cuvette holder 7a and start measurement as soon as possible but no later than 1 minute after filling the microcuvette by gently pushing the cuvette holder to its measuring position 7b 8 During measurement the measuring window is shown ...

Page 46: ...10 9a 9b 9c 46 ...

Page 47: ...rm result by pressing button below the Accept symbol Reject result by pressing button below the Reject symbol A rejected result will be saved but marked with a flag as rejected The display shows the main menu NOTE Do not remeasure the filled microcuvette 10 Always handle blood specimens with care they might be infectious Consult local envi ronmental authorities for proper disposal Always wear prot...

Page 48: ...1 2 4 3 6 5 48 Routine Use QC Test ...

Page 49: ...enu Take a microcuvette from the package HemoCue WBC DIFF Microcuvette or HemoCue WBC Microcuvette For single packaged microcuvettes open the wrapping and take out the microcuvette 3 Press right button for Menu QC Test 4 Press center button to scroll down and choose QC Test Press right button to accept QC Test and move to the next window 5 Press right button to confirm QC test 6 Enter required dat...

Page 50: ...50 7 8 9a 9b 10 ...

Page 51: ...ccording to Blood Collection Venous Sample and Control Material sec tions Place the microcuvette into the cuvette holder 9a and start measurement as soon as possible but no later than 1 minute after filling the microcuvette by gently pushing the cuvette holder to its measuring position 9b It will automatically slide into the cor rect position and the measurement starts 10 During measurement the me...

Page 52: ...12 11a 11b 11c 52 ...

Page 53: ...sing button below the Accept symbol Reject result by pressing button below the Reject symbol A rejected result will be saved but marked with a flag as rejected After rejecting the result main menu is shown NOTE Do not remeasure the filled microcuvette 12 Always handle blood specimens with care they might be infectious Consult local envi ronmental authorities for proper disposal Always wear protect...

Page 54: ...1 2 3 4 5 6 54 Review Delete Results ...

Page 55: ...default the PIN Code is set to 0000 For changing the PIN Code see step 19 in the Settings section Enter PIN code by pressing the button below up arrow to change digit Press right button to confirm and move to next digit After entering the four digit PIN Code press right button to accept and move to next window 5 The display shows Home Review Delete and Settings Press center button to enter Review ...

Page 56: ...7 8 9 56 ...

Page 57: ...microcuvette Return to main menu by pressing center button and then left button 8 To jump between result and data windows press center button Press left button to return to main menu Delete Results 9 Delete window is shown Press right button to delete all results stored in the analyzer To cancel press left button The main menu is shown NOTE Single results can not be deleted ...

Page 58: ...1 2 3 4 5 58 Maintenance Daily Maintenance ...

Page 59: ...o not autoclave If the optical parts are stained an error code is displayed Clean according to Maintenance Optical Parts section 4 Wait 15 minutes before replacing the cuvette holder 5 Place the cuvette moving arm in loading position before replacing the cuvette holder Clean the cover with alcohol 20 70 or a mild detergent Only the WBC DIFF cuvette holder is to be used with the WBC DIFF analyzer T...

Page 60: ...60 1 2b 3 Maintenance Optical Parts 2a 4 ...

Page 61: ...on the left in the open ing Move the cleaner alongside of the cuvetteholder to get the right angle for cleaning the optical parts 2b 3 Move from side to side 5 10 times If the cleaner is stained repeat using a new cleaner 4 Wait 15 minutes before performing a new measurement One HemoCue Cleaner WBC is included with the analyzer Contact your local distributor to order additional cleaners NOTE Make ...

Page 62: ...ed actions for each flag or Error Code described If the Troubleshooting Guide is unable to resolve the problem please contact your local HemoCue distributor or HemoCue AB The ana lyzer should be cleaned as described in the Maintenance section prior to service or disposal The analyzer has no serviceable parts NOTE Do not open the cover of the analyzer The warranty is void if the cover of the analyz...

Page 63: ...d be verified with a suitable laboratory method and be questioned as to the pathological condition of the patient The printout will show an asterisk instead of the display symbol The differential count is not presented when the total WBC is below 1 x 109 L If a differential count is required the sample should be verified with a suitable laboratory method ...

Page 64: ...total white blood cell count is below 0 3 x 109 L The sample should be verified with a suitable laboratory method The measured white blood cell count is above 30 0 x 109 L The sample should be verified with a suitable laboratory method ...

Page 65: ...ement as descri bed in Routine Use Patient Test or QC Test sections 2 If the problem persists the sample should be verified with a suitable laboratory method Err02 Uneven spatial distribution of detected cells Take a new microcuvette repeat the measurement as described in Routine Use Patient Test or QC Test sections Err03 Image or part of the image area is out of focus 1 Take a new microcuvette re...

Page 66: ...easurement as described in Routine Use Patient Test or QC Test sections Make sure that the microcuvette is filled with sample Err34 Stray light detected 1 Make sure that the analyzer is not exposed to any bright light sources 2 If the problem continues the analyzer needs service Contact your local distributor Err35 The battery power is too low Replace the batteries six type C LR14 HR14 batteries 1...

Page 67: ...in Start Up section 3 The analyzer needs service Contact your local distributor The display shows erroneous characters 1 The display is out of order 2 The microprocessor is out of order The analyzer needs service Contact your local distributor The cuvette holder is not mov ing into correct position The magnet in the cuvette holder is missing The analyzer needs service Contact your local distributo...

Page 68: ...designed to establish agreement with Manual method for the differential white blood cell count Manual method for total white blood cell count No calibration is needed as the system is factory calibrated Warning and Precaution The microcuvettes are for In Vitro Diagnostic use only Always handle blood specimens with care they may be infectious Consult local environment authorities for proper disposa...

Page 69: ...BC Microcuvettes Lancet capillary samples Pipette or other transfer device venous samples Lint free tissue non fraying Quality Control When the HemoCue WBC DIFF Analyzer is started a quality control self test is automatically performed to verify perfor mance If the test fails an error code will be displayed For each measurement quality controls are made on The HemoCue WBC DIFF Analyzer The HemoCue...

Page 70: ...en expressed as a mean 2SD 95 Range 3 6 Months 1 Year 2 6 Years 6 12 Years White Blood Cell Count x109 L 12 6 11 5 10 5 9 4 Neutrophils x109 L 1 6 1 7 1 5 8 2 8 Lymphocytes x109 L 4 12 3 5 11 6 9 1 5 Monocytes x109 L 0 2 1 2 0 2 1 0 0 2 1 0 0 2 1 0 Eosinophils x109 L 0 1 1 0 0 1 1 0 0 1 1 0 0 1 1 0 ...

Page 71: ...9 L Adults White Blood Cell Count 4 0 10 0 NA Neutrophils 2 0 7 0 40 80 Lymphocytes 1 0 3 0 20 40 Monocytes 0 2 1 0 2 10 Eosinophils 0 02 0 5 1 6 Basophils 0 02 0 1 1 2 The values above may vary due to a wide range of factors such as sex diurnal variations exercise physical stress or trauma pregnancy indigestion of food and cigarette smoking ...

Page 72: ...ing samples for an extended period may affect the result d Results above the measuring range will be displayed as HHH Results below the measuring range will be displayed as LLL e Discard sample if clots f For interference studies see chapter Known Interferences Specific Performance Characteristics Linearity The white blood cell count for the WBC DIFF system has accord ing to the FDA Guidance Prema...

Page 73: ...licates per sample using 1 analyzer and 1 batch of cuvettes N WBC Level Total WBC Neutrophils Lymfocytes Monocytes Eosinophils Mean x109 L SD x109 L CV Mean x109 L SD x109 L CV Mean x109 L SD x109 L CV Mean x109 L SD x109 L Mean x109 L SD x109 L 31 Low 2 8 0 14 5 0 1 5 0 11 7 3 1 0 0 08 7 8 0 2 0 03 0 1 0 02 31 Normal 6 1 0 17 2 8 3 4 0 13 3 7 2 2 0 10 4 6 0 3 0 07 0 1 0 03 31 High 18 1 0 57 3 1 1...

Page 74: ... Figure 2 and for lymphocytes in Figure 3 Coefficients y 0 16 0 96x n 596 r2 0 968 r 0 984 y x Beckman Coulter LH750 Neutrophils x109 L HemoCue WBC DIFF Neutrophils x10 9 L 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Coefficients y 0 24 1 01x n 762 r2 0 994 r 0 997 y x HemoCue WBC DIFF total WBC x10 9 L Beckman Coulter LH750 total WBC x109 L HemoCue WBC DIFF Lymphocytes x10 9 L Beckman Coulter LH750 Lym...

Page 75: ...illary sample for Sysmex was taken in a microtube Coefficients y 0 33 0 88x n 96 r2 0 867 r 0 931 y x Sysmex XS 1000i Neutrophils x109 L HemoCue WBC DIFF Neutrophils x10 9 L Coefficients y 0 47 0 94x n 103 r2 0 859 r 0 927 y x HemoCue WBC DIFF total WBC x10 9 L Sysmex XS 1000i total WBC x109 L HemoCue WBC DIFF Lymphocytes x10 9 L Sysmex XS 1000i Lymphocytes x109 L Coefficients y 0 27 1 10x n 96 r2...

Page 76: ...tandards IEC 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements IEC 61010 2 101 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment UL 61010 CSA C22 2 No 61010 1 Safety requirements for electrical equipment for...

Page 77: ...r W Separation distance according to fre quency 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 applicable to the freque...

Page 78: ...es Mains power quality should be that of a typical commercial or hospital environment 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 environment Voltage dips short interrup tions 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 5 cycles 70 U 30 d...

Page 79: ...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 recom mended separation distance in meters m Field strengths from fixed RF transmitters as determi...

Page 80: ...e radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the elec tromagnetic 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 81: ...ion test Compliance Electromagnetic environment guidance RF emissions Group 1 The HemoCue systems uses RF energy only for its internal function Therefore its 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 connec...

Page 82: ...RF emissions are very low and not likely to cause any interference in nearby electronic equipment The HemoCue WBC DIFF system is suitable for use in all estab lishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Warranty The analyzer carries a 24 month warranty from the day of rece...

Page 83: ...ition Class II Special Controls Guidance Document Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells Final Guidance for Indus try and FDA Document issued at December 4 2001 CSLI Document H26 A2 Vol 30 No 14 Validation Veri fication and Quality Assurance of Automated Hematology Analyzers CLSI Document EP09 A2 IR Vol 30 No 17 Method Com parison and ...

Page 84: ...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 903501 140726 GB BERGSTENS HBG ...

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