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Contents

Section

Page

1

HemoCue Hb 801 System

1

2

Components/Analyzer Overview

2

3

Display Overview

3

4

Power Options

4

5

Start-up

5

6

Turn Off

5

7

Settings 

Date and Time, or Bluetooth

®

6

8

Measuring 

Capillary Blood

7

9

Measuring 

Venous Blood and Control Material

9

10

Cleaning and Disinfection

11

11

Quality Control

13

12

Principle of Method

13

13

Previous Results

14

14

Connectivity and External Applications

14

15

Troubleshooting

15

16

Expected Values

17

17

Specific Performance Characteristics

17

18

Limitations

19

19

Safety and Compliance

20

20

References

21

21

Symbols Used

21

22

Technical Specifications

22

Содержание Hb 801

Страница 1: ...HemoCue Hb 801 Operating Manual ...

Страница 2: ...emoCue America 250 South Kraemer Boulevard Brea CA 92821 USA Phone Fax 46 77 570 02 10 46 77 570 02 12 Phone general Phone customer service Phone technical support Fax customer service 800 881 1611 800 323 1674 800 426 7256 800 333 7043 info hemocue se hemocue com web hemocue com hemocue com ...

Страница 3: ...ry Blood 7 9 Measuring Venous Blood and Control Material 9 10 Cleaning and Disinfection 11 11 Quality Control 13 12 Principle of Method 13 13 Previous Results 14 14 Connectivity and External Applications 14 15 Troubleshooting 15 16 Expected Values 17 17 Specific Performance Characteristics 17 18 Limitations 19 19 Safety and Compliance 20 20 References 21 21 Symbols Used 21 22 Technical Specificati...

Страница 4: ...age insert regarding system limitations including interfering substances Intended Use The HemoCue Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood K2 EDTA and Li Heparin in point of care settings The HemoCue Hb 801 System is intended to be used to determine the hemoglobin concentration for adults adolescents children and infants above 1 ...

Страница 5: ... Hb 801 Operating Manual HemoCue Hb 801 Quick Reference Guide Materials required but not provided HemoCue Hb 801 Microcuvettes protective gloves lint free wipe high flow lancet for capillary samples pipette or other transfer device for venous samples hydrophobic surface for venous samples Spare parts battery cover microcuvette holder power adapter USB cable plug Optional items HemoCue software app...

Страница 6: ... instructions for use 14 ready for measurement 15 cleaning needed 16 error code 17 discard microcuvette 18 analyzer lockout See section 14 Display Animations Animations appearing in normal conditions Ready State Starting position for most actions Busy State The analyzer has work in progress If continuously busy see section 15 Always discard the microcuvette when a result is displayed If forgotten ...

Страница 7: ...Battery to temperatures above 60 C 140 F When using HemoCue Rechargeable Battery no other batteries shall be installed Before storing the analyzer make sure to remove batteries Electrical Outlet 1 Mount the plug onto the power adapter and connect the USB cable to the power adapter 2 Connect the USB cable to the analyzer USB port and then connect the power adapter to the electrical outlet Batteries...

Страница 8: ...king properly continue pressing the on off button during start up To compare see section 3 6 Turn Off 1 Press and hold on off button until the analyzer is in Busy State Release and wait for the analyzer to turn off When changing settings in section 7 or viewing previous results in section 13 it is not possible to turn off the analyzer If needed exit the settings or previous results and then turn o...

Страница 9: ...starts to flash 3 To change date and time press left button 4 Set the correct values Go to next value To quickly scroll between digits press and hold the left button 5 Exit Press both buttons once Bluetooth Buttons Extra Information 1 Make sure the analyzer is in Ready State Display showing 2 Enter Press and hold both buttons until the date time and Bluetooth areas on the display starts to flash 3...

Страница 10: ...ng Avoid fingers with rings on Sample at the side of the fingertip for best blood flow and comfort 2 Clean the fingertip and allow to dry 3 Using your thumb lightly press the finger from the top of the knuckle towards the fingertip to stimulate blood flow 4 Press lightly towards the fingertip and puncture using a high flow lancet 5 Wipe away the first 2 or 3 drops of blood Press lightly towards th...

Страница 11: ...ult again see section 13 Repeat Testing Pre analytical factors can influence hemoglobin values obtained from capillary blood These factors can include but are not limited to Lancet size and type Capillary circulation status Extracellular fluid in sample due to poor sampling technique Selection of puncture site Improper filling of microcuvette Confirmation of an unacceptable or unexpected laborator...

Страница 12: ...local safety procedures for disposal of used microcuvettes HemoCue Hb 801 Microcuvettes are for single use only Make sure venous blood samples are properly mixed before use 1 If refrigerated allow the sample to reach operating con ditions Mix thoroughly on mixer for at least 2 minutes or invert manually 8 10 times When mixing controls follow instructions for the control material used 2 Place a dro...

Страница 13: ... microcuvette holder and press down The result will be displayed within a second 7 When a result is displayed remove and discard the micro cuvette The result is displayed for 10 seconds after measurement To change this setting see section 14 To see the result again see section 13 10 ...

Страница 14: ...cuvette holder 2 Lightly dampen a cotton swab with cleaning agent Clean all surfaces in the cavity make sure to clean all the way down 3 Clean the microcuvette holder with cleaning agent Let the microcuvette holder dry outside of the analyzer while moving on to step 4 4 Lightly dampen a wipe with cleaning agent and clean all outer surfaces Now the analyzer is ready for disinfection Follow steps 5 ...

Страница 15: ...wet for 2 minutes 7 Make sure that the surfaces in step 5 and 6 have been wiped repeatedly in order to stay wet for the whole 2 minutes wet time contact time 8 Remove any excess disinfectant or allow to air dry Make sure all parts are completely dry before reattaching the microcuvette holder and turning on the analyzer 12 ...

Страница 16: ...ue Hb 801 System consists of an analyzer together with microcuvettes The micro cuvette serves both as a pipette and as a sample carrier Blood is drawn into the microcuvette cavity by capillary action The measurement takes place in the analyzer which measures the absorbance of whole blood at an Hb HbO2 isosbestic point 506 nm and at a wavelength 880 nm to compensate for possible interfering backgro...

Страница 17: ...ld 3 To exit previous results press both buttons once 14 Connectivity and External Applications The analyzer can be connected to external software applications using either the USB cable or Bluetooth Low Energy wireless connection This allows for change of certain default features or transfer of data Software applications are optional items For more information contact the local distributor or Hem...

Страница 18: ... or HemoCue America Symptom Further Actions E00 E30 Perform Main Actions above analyzer not meas uring Perform Main Actions above Make sure to press down the micro cuvette during measurement If the display shows instead of a result fill a new microcuvette and perform a measurement see section 8 or 9 If needed perform Main Actions above unexpected result Possible causes are e g incorrect sampling t...

Страница 19: ...damaged Force a restart Press and hold both buttons for 15 seconds date and time area flashing in Ready State Set date and time If the problem occurs again Set date and time and keep the analyzer powered for at least 24 hours either by bat teries or USB cable bad wireless or USB connection Follow instructions for software application used If the result is still deviating from expected value after ...

Страница 20: ...according to CLSI EP05 A3 Repeatability Within laboratory Precision Reproducibility Control Level N g dL SD g dL CV SD g dL CV SD g dL CV 1 240 6 34 0 05 0 7 0 04 0 7 0 06 0 9 2 240 11 50 0 05 0 4 0 05 0 5 0 06 0 5 3 240 15 36 0 15 1 0 0 16 1 0 0 17 1 1 Results summarized from capillary precision study repeatability Hb Level g dL N Min g dL Max g dL SD g dL CV 7 0 2 1 4 5 0 0 11 7 0 40 7 1 23 3 2 ...

Страница 21: ...oncentrations of the substances tested Substance Test Concentration Unit Substance Test Concentration Unit Acetaminophen 1324 µmol L Total protein 15 g dL Ascorbic acid 342 µmol L Salicylic acid 4 34 mmol L Creatinine 442 µmol L Simvastatin 49 µmol L HbCO 10 Tetracycline 34 µmol L HbO2 50 Triglyceride 1500 mg dL Hemolysis 10 g L Urea 42 9 mmol L Ibuprofen 2425 µmol L Uric acid 1 4 mmol L MetHb 25 ...

Страница 22: ...ng substances have been tested according to CLSI EP07 to determine the inter fering concentration Substance Concentration unit Hb Concentration g dL Result Conjugated bilirubin 23 mg dL 10 Interfering Up to 40 mg dL 20 Non interfering Unconjugated bilirubin 12 mg dL 10 Interfering 23 mg dL 20 Interfering Intralipid 214 mg dL 10 Interfering 483 mg dL 20 Interfering Leucocytes 260 x 109 L 6 8 14 7 I...

Страница 23: ...aintained in order that the device will perform as intended It is recommended to evaluate the electromagnetic environment prior to use of the system Do not use this system in close proximity to sources of strong electromagnetic radiation for example unshielded intentional RF sources as these can interfere with the proper operation Should you suspect electromagnetic interference make sure to Place ...

Страница 24: ...pproved Guideline Third Edition CLSIEP37 ED1 SupplementalTablesforInterferenceTestinginClinicalChemistry FirstEdition CLSI H15 A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Approved Standard Third Edition Dacie and Lewis Practical Haematology Elsevier Limited 12th Edition 2016 and referen ces herein HemoCue Hb 801 Microcuvettes Package Insert Soldin...

Страница 25: ...el dimensions 87x143x45 mm 3 4x5 6x1 8 in weight batteries excluded 250 g 0 55 lbs power adapter alternatives input rating FW8012USB 05 Y 100 240 V 50 60 Hz 160 80 mA PSAI05R 050QL6 R 100 240 V 50 60 Hz 300 150 mA analyzer supply rating 5 V USB 800 mA battery alternatives 3 type AA 1 5 V Alkaline 3 type AA 1 2 V NiMH 1 HemoCue Rechargeable Battery 131901 3 6 V 2 6 Ah pollution degree 2 overvoltage...

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Страница 28: ...HemoCue AB Kuvettgatan 1 SE 262 71 Ängelholm Sweden 46 77 570 02 10 46 77 570 02 12 hemocue com info hemocue se 901912 190204 US ...

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