HemoCue HB 201+ & 100 microcuvettes Owner’s Manual

HB 201+ & 100 microcuvettes
Owner’s Manual

HemoCue ® Hb 201 +System

Intended Use
Quantitative determination of hemoglobin in capillary, venous, or arterial blood.
The  HemoCue ® Hb 201 System is used for the quantitative determination of hemoglobin in whole blood using a specially designed analyzer, the HemoCue Hb 201 + Analyzer, and specially designed micro cuvettes, the HemoCue Hb 201 Microcuvettes. HemoCue Hb 201 Microcuvettes are for In Vitro Diagnostic use only. The HemoCue Hb 201 + The analyzer is only to be used with HemoCue Hb 201 Microcuvettes.
The HemoCue Hb 201+System complies with the IVD Medical Device Directive 98/79/EC and carries the CE mark.
Warranty
The analyzer carries a 24-month warranty from the day of receipt. Any other use of the system than recommended by the manufacturer, including opening the cover of the the analyzer will void the warranty.
Service and Disposal
Consult local environmental authorities for proper disposal. The analyzer should be cleaned prior to service or disposal.
Read and follow this operating manual and the HemoCue Hb 201 Microcuvettes package insert to attain optimum performance and safety. Any other use of the system than
recommended by the manufacturer may impair safety.
Further information may be obtained from the HemoCue distributor or HemoCue AB.

Analyzer Overview

Components

1. HemoCue Hb 201 + Analyzer
2. Power adapter
3. HemoCue Hb 201 + Operating Manual & Quick Reference Guide

Materials required but not provided
HemoCue Hb 201 Microcuvettes
Lancet*
Pipette or another transfer device
Lint-free wipe
Hydrophobic surface
Spare parts
Battery Lid
Power adapter*
Cuvette Holder
Optional items**
Printer
Software applications
Cables for PC and printer connection
HemoCue Cleaner
Hard carrying case
HemoCue Lancet
HemoCue Hb 201 + Control Cuvette

• for capillary samples
  ** for venous/arterial samples
  *** not available in all countries

Start-up

Always follow operating and storage conditions listed in the section Technical Specifications.
Allow the analyzer to reach operating temperature before use.
Place the analyzer on a horizontal and stable surface. Connect the power adapter to the power inlet or insert 4 batteries, see section Analyzer Overview, fig. 2.
Only use the power adapters and batteries listed in the section Technical Specifications.

1. In the Loading position (see also section Analyzer Overview, fig. 1C), press left button until all symbols appear on the display.
2. The software version is displayed followed by time & date, audio signal “ ”, an hourglass “ ”, and “Hb”. During this time the analyzer performs a self-test.
3. Three flashing dashes indicate that the analyzer has passed the self-test and is ready for use.

To turn the analyzer off press left button until OFF is displayed. When turned on again the most recent result is displayed if the cuvette holder is in the Measuring position (see section Analyzer Overview, fig. 3).
Low battery is indicated with a battery symbol “ ”.

Set-up

1. In the Loading position (see section Analyzer Overview, fig. 1C), enter set-up by pressing both buttons until a flashing QC symbol is displayed.
2. An audio signal (e.g. to indicate measurement is completed): press the right button to scroll until the audio symbol is displayed. Use the left button to a) activate or b) deactivate.
3. Time & Date: press the right button to scroll until characters for time, year, and date are displayed. The hour character is flashing, press the left button to change (hold for quick advancement). Press the right button to continue to the next character.
4. Exit set-up by pressing the right button until three flashing dashes are displayed.

printer and Connectivity

Only use ASCII printers recommended by HemoCue. Always follow instructions for the use of the printer.

1. Connect analyzer to printer or computer* via serial or USB port (analyzer can be turned on or off).
2. When the measurement is completed, the result will automatically be printed or transferred to the computer with the date and time.
   Time and date must be activated before data can be printed.

• The analyzer can be connected to HemoCue software or external software applications for the transfer of data, using either a USB cable or serial cable. For more information, contact the local distributor or HemoCue AB.

Specimen Collection Capillary

Be aware that peripheral circulatory failure of the patient could affect the result of a capillary sample.
Always wear protective gloves. Handle blood with care, as it may be infectious.
Follow local safety procedures for disposal of used micro cuvettes.
Important: Fill the micro cuvette within 3 minutes after removal from the package.
Always keep the vial properly closed.

1. Make sure that the patient’s hand is warm and relaxed. Use the middle or ring finger for sampling. Avoid fingers with rings on.

2. Clean the fingertip with disinfectant and allow it to dry.

3. Using your thumb, lightly press the finger from the top of the knuckle towards the fingertip to stimulate blood flow.
   

4. Sample at the side of the fingertip for best blood flow and comfort.

5. Press lightly towards the fingertip and puncture using a lancet.

6. Wipe away the first 2 or 3 drops of blood. Press lightly towards the fingertip until another drop of blood appears.

7. When the blood drop is large enough, fill the micro cuvette completely in one step. Do not refill.
   Follow the section Measurement Procedure to perform the measurement.

Specimen Collection Venous/Arterial

Always wear protective gloves. Handle blood with care, as it may be infectious.
Follow local safety procedures for disposal of used micro cuvettes.
Use anticoagulants (e.g. EDTA or heparin), preferably in solid form to avoid dilutional effects. Hemoglobin remains stable for days, provided the blood does not become
contaminated.
Important: Fill the micro cuvette within
3 minutes after removal from the package. Always keep the vial properly closed.

1. If refrigerated, allow the sample to reach operating temperature before mixing.
   Mix thoroughly on a mixer for at least 2 minutes or gently invert manually 8–10 times.

2. Place a drop of blood onto a hydrophobic surface using a transfer device.

3. Fill the micro cuvette completely in one step. Do not refill.
   Follow the section Measurement Procedure to perform the measurement.

Measurement Procedure

Start measurement no later than 10 minutes after filling the micro cuvette.

1.  Wipe off the specimen from the outside of the micro cuvette, and make sure no specimen is drawn out from the open end. Visually inspect the micro cuvette.
   Important: If the micro cuvette is not completely filled with blood or if there are air bubbles, discard and fill a new microcuvette. Small bubbles around the edges can be ignored.

2. Place the micro cuvette in the cuvette holder and start measurement by gently sliding the cuvette holder to the Measuring position (see section Analyzer Overview, fig. 3).

3. Whilst measuring, will be displayed.

4. The result is displayed as long as the cuvette holder is in the Measuring position (see section Analyzer Overview, fig. 3).

Discard the micro cuvette after measurement.
Microcuvettes are for single use only.
If not in use, an analyzer operated on batteries will automatically turn off after 5 minutes.

Quality Control

The analyzer has internal quality control, the self-test. It automatically verifies the performance of the analyzer every time it is turned on and every second hour when in use.
If in addition an external quality control is required by local or other regulations, only use controls recommended by HemoCue.
Perform External Quality Control
Always follow instructions for the use of the control solution.

1. In the Loading position (see section Analyzer Overview, fig. 1C): press both buttons until a flashing QC symbol is displayed, then the left button to select QC-test (press the right button
   to unselect).

2. Place a drop of control solution on a hydrophobic surface. Fill the micro cuvette completely in one step. Do not refill.
   Follow the section Measurement Procedure to perform the measurement. After measurement, the analyzer automatically exits QC-test.

View Results

Up to 600 results can be stored, after which the oldest will be deleted.
In the Loading or Measuring position (see section Analyzer Overview, fig. 1C or fig. 3) press the left or right button to scroll between stored results.

1. To view the sequence number, press any button until displayed. When released, the result is shown. The most recent result is always sequence number 1.
2. Exit View Results: in the Loading position (see section Analyzer Overview, fig. 1C) wait until three flashing dashes are displayed.

Delete Results

Deleted results cannot be recovered.

1. In the Loading or Measuring position (see section Analyzer Overview, fig. 1C or fig. 3) press both buttons until a flashing QC symbol is displayed. Press the right button, a flashing waste bin is displayed.
2. Delete the current result (must be done immediately after measurement): press the left button until a waste bin, a warning triangle, and “1” are displayed followed by “0” which confirms the deletion.
3. Delete all results; press both buttons until the waste bin, warning triangle, and total number of stored results are displayed, followed by “000” which confirms the deletion.

Maintenance Daily

The cuvette holder should be cleaned after each day of use.

1. In the Loading position (see section Analyzer Overview, fig. 1C) press the catch and carefully rotate the cuvette holder as far as possible to the left.
2. Remove the cuvette holder completely by pulling it off the steel pin.
3. Clean the cuvette holder with alcohol (20-70%) or mild detergent.
4. The cuvette holder must be completely dry before reattaching. Allow a minimum of 15 minutes to dry. The cover may be cleaned with alcohol (20-70%) or mild detergent.

Maintenance Optical parts

Clean optical parts when required in section Troubleshooting.
Follow instructions thoroughly to make sure the cleaner reaches both the upper and lower cover glasses.

1. Turn off the analyzer. Follow steps 1-2 in section Maintenance Daily to remove the cuvette holder. Push the HemoCue Cleaner as much as possible into the opening of the analyzer. a) Move from side to side 5-10 times. b) Placed to the left, push the cleaner back and forth 5-10 times, cleaning the cover glasses. If the cleaner is stained, repeat a) and b) with a new cleaner.
2. The optical parts must be completely dry before the cuvette holder is reattached. Allow a minimum of 15 minutes to dry.

For alternatives to the HemoCue Cleaner contact the local distributor or HemoCue AB.

Troubleshooting

If the problem remains after recommended actions below are taken, contact the HemoCue distributor or HemoCue AB. The analyzer should be cleaned prior to service,
see section Maintenance for instructions. If any spare parts are lost or damaged, see section Components.
Do not open the cover of the analyzer. The warranty is void if the analyzer has been opened.

• Follow the relevant section in this operating manual.

problem continues, see the specific error code below, or the analyzer needs service.
0.00E+00| 1. Faulty microcuvette.| la. Check the expiry date.
lb. Fill a new microcuvette and perform the measurement.’
E01-E02| 1. Dirty optical parts.
2. Analyzer is too hot/cold.
3. Magnet missing in cuvette holder.| 1. Clean optical parts.’
2. Turn the analyzer off, and allow it to reach operating temperature before use.
3. Order a new cuvette holder.
0.00E+00| 1. Analyzer exposed to direct light.| 1. Avoid direct light exposure.
E05. E06| 1. Analyzer too hot/cold or exposed to direct light| la. Turn the analyzer off, and allow it to reach operating temperature before use. lb. Avoid direct light exposure.
0.00E+00| 1. Battery power is too low.| la. Batteries need to be replaced. lb. Use a power adapter.
0.00E+00| la. The absorbance is too high. lb. Faulty microcuvette or sample. lc. Dirty or blocked optical parts.| la and lb. Ensure the analyzer and micro cuvettes are used according to the operating manual and relevant package insert.
la and lc. Clean optical parts.’
E09-E30| 1. Internal error in the analyzer.| 1. Clean optical parts.’
0.00E+00| 1. Current measurement incorrectly stored.| 1. Delete all stored results.
HHH| 1. Result exceeds measuring range.| la. Fill a new microcuvette and perform the measurement. lb. Confirm results with the laboratory method.
---|---|---
No characters displayed| I. Analyzer not receiving power.
2. Faulty display.| la. Ensure the power adapter is properly connected and the cable is not damaged. lb. Batteries need to be replaced.
2. Analyzer needs service.
Erroneous characters displayed| 1. Faulty display/electronics.| 1. Analyzer needs service.
is displayed| 1. Low battery.
2. Faulty power adapter.| 1. Batteries need to be replaced.
2. Ensure the power adapter is properly connected and the cable is not damaged.
and Hip’ continuously displayed| 1. Faulty cuvette holder/analyzer.| 1. The analyzer needs service.
Unexpected patient or control results| Patient sample and control solution
1. Microcuvettes expired, damaged, or improperly stored.
2.Microcuvette contaminated.
3. Dirty optical parts.
4. Air bubbles in fitted microcuvette.
5. Faulty optical parts.
6. Incorrect sampling technique.
7. Measurement started later than 10 minutes after filling the micro cuvette.
Control solution
8. Control solution not compatible.
9. Improper handling of control solution.
10. Control solution expired or improperly stored.| Patient sample and control solution
1. Check expiry date and storage conditions.
2. Fill a new microcuvette and perform the measurement.
3. Clean optical parts.
4. Fill a new microcuvette and perform the measurement.
5. The analyzer needs service.
6. Fill a new microcuvette and perform the measurement. *
7. Start measurement no later than 10 minutes after filling the micro cuvette.
Control solution
8. Only use control solutions recommended by HemoCue.
9. Always follow instructions for the use of the control solution.
10. Check expiry date and storage conditions.

Performance, EMC, and Electrical Safety

Principle of the method and procedure
The microcuvette serves both as a pipette and as a measuring cuvette and is for single use only. Blood is drawn into the micro cuvette by capillary action and an azide methemoglobin reaction occurs.
The analyzer measures transmittance at two wavelengths to compensate for turbidity. The hemoglobin level is calculated and presented. The system is factory calibrated against the international reference method
for hemoglobin determination, ICSH. No further calibration is needed.
For information regarding the subjects below, refer to HemoCue Hb 201 Microcuvettes Package Insert
Limitations
Expected Values
Storage and Handling (HemoCue Hb 201 Microcuvettes)
Composition
Specific Performance Characteristics
References

• HemoCue Hb 201 Microcuvettes Package Insert
• Makarem, A. In clinical Chemistry: Principles and Techniques, 2nd ed., Henry, R.J., Cannon, D.C., and Winkelman, J.W., Harper and Row, Hagerstown, M.D., 1974, pp. 1125–1147
• Dacie and Lewis, Practical Haematology, Ninth Edition, 2001
• Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard; CLSI Document H15-A

EMC and Electrical Safety
The analyzer has been tested and complies with the following standards:

• IEC 61010-1
• IEC/EN 61010-2-101
• IEC/EN 61326-2-6 (including applicable parts of IEC/EN 61326-1)

The analyzer has been tested for indoor use.
It is recommended to evaluate the electromagnetic environment prior to the use of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these can interfere with the proper operation.
Note : It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to the customer or user.
Note : It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.

Symbols used

| Explanation
---|---
| Caution
| Consult instructions for use
| CE mark
| In Vitro Diagnostic medical device
| Biological risk
| Manufacturer
| Serial number
| Catalog number
| Temperature limitation
| Humidity limitation
| Only valid within the European Community. Indicates separate collection for waste of electrical and electronic
equipment.
| USB port
1010| Serial port
| DC inlet
| Efficiency level
on power adapter
| Class II equipment on the power adapter
| For indoor use only on the power adapter

Technical Specifications

HemoCue AB | Kuvettgatan 1 | SE-262 71 Ängelholm | Sweden
+ 46 77 570 02 10
+ 46 77 570 02 12
hemocue.com | info@hemocue.se
901702 180926 EN DE FR NL

Documents / Resources

| HemoCue HB 201+ & 100 microcuvettes [pdf] Owner's Manual
HB 201 100 microcuvettes, HB 201, 100 microcuvettes, microcuvettes
---|---

References

• Setting the standard for accuracy in point-of-care testing (POCT) - HemoCue

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