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Table of Contents
Related Manuals for HemoCue Hb 801
Summary of Contents for HemoCue Hb 801
- Page 1 HemoCue Hb 801 ® Operating Manual...
- Page 2 Manufacturer HemoCue Distributor USA HemoCue AB HemoCue America Kuvettgatan 1 250 South Kraemer Boulevard SE-262 71 Ängelholm Brea, CA, 92821 Sweden Phone +46 77 570 02 10 Phone (general) 800.881.1611 +46 77 570 02 12 Phone (customer service) 800.323.1674 Phone (technical support) 800.426.7256...
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Page 3: Table Of Contents
Contents Section Page HemoCue Hb 801 System Components/Analyzer Overview Display Overview Power Options Start-up Turn Off Settings Date and Time, or Bluetooth ® Measuring Capillary Blood Measuring Venous Blood and Control Material Cleaning and Disinfection Quality Control Principle of Method... -
Page 4: Hemocue Hb 801 System
Hb 801 System ® The HemoCue Hb 801 System consists of a HemoCue Hb 801 Analyzer and HemoCue Hb 801 Microcuvettes. Read and follow this operating manual together with the package insert (provided with the microcuvettes), for optimum performance and safety. For more information, contact the local distributor or HemoCue America. -
Page 5: Components/Analyzer Overview
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 •... -
Page 6: Display Overview
3 Display Overview The display during start-up, when all display segments are lit: date time battery status previous results, sequence cleaning reminder* QC reminder* connectivity* Bluetooth setting; on USB cable connected 10. measurement result unit 12. analyzer busy 13. consult instructions for use 14. -
Page 7: Power Options
* For some rechargeable AA batteries, the analyzer may indicate low battery only for a short period of time before shut- ting down. Change or charge batteries. ** This option is set when ordering the analyzer. For more information, contact the local distributor or HemoCue America. -
Page 8: Start-Up
Charging • Rechargeable AA batteries: Charge separately according to instructions for batteries used. • HemoCue Rechargeable Battery: Charge in the analyzer (connected to an electrical outlet or a computer). 5 Start-up Place the analyzer on a horizontal and stable surface. -
Page 9: Settings Date And Time, Or Bluetooth
7 Settings Date and Time, or Bluetooth ® Follow these procedures to change date and time, or Bluetooth settings. ® To exit settings at any time, press both buttons once. Date and Time Buttons Extra Information Make sure the analyzer is in Ready State. Display showing: Enter: Press and hold both buttons until the date, time, and Bluetooth areas on the display... -
Page 10: Measuring Capillary Blood
Always wear protective gloves. Handle blood with care, as it may be infectious. Follow local safety procedures for disposal of used microcuvettes. • HemoCue Hb 801 Microcuvettes are for single use only. • Be aware that peripheral circulatory failure of the patient can affect the result of a capillary sample. - Page 11 Wipe off excess blood from the outside of the micro- cuvette. Make sure that no blood is drawn out from the microcuvette. Visually inspect the microcuvette. Precaution: • If the microcuvette is not completely filled with blood, or if there are air bubbles, discard and fill a new microcuvette.
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Page 12: Measuring Venous Blood And Control Material
Always wear protective gloves. Handle blood with care, as it may be infectious. Follow 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. - Page 13 Make sure the analyzer is in Ready State. Insert the filled microcuvette into the microcuvette holder and press down. The result will be displayed within a second. 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.
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Page 14: Cleaning And Disinfection
• Cleaning agents: water, alcohol (20–70 %), mild detergent, or recommended disinfectant. • Disinfectant: Super Sani-Cloth Germicidal Disposable Wipe, EPA Reg. No. 9480-4. Only use disinfectant recommended by HemoCue. Read and follow instructions for the disinfectant used. Precaution: • Make sure to clean and disinfect the analyzer on a regular basis. - Page 15 Wipe all outer surfaces repeatedly with a Super Sani-Cloth Germicidal Disposable Wipe. Make sure that all surfaces stay wet for 2 minutes. 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).
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Page 16: Quality Control
11 Quality Control The HemoCue Hb 801 Analyzer has an internal quality control, a self-test. It automatically verifies the performance of the analyzer every time the analyzer is turned on, when the micro- cuvette holder is put back into place after removal, and every hour when in use. -
Page 17: Previous Results
Do not leave the analyzer exposed or unattended. HemoCue AB is not responsible for any threats related to cybersecurity originating from the user’s IT infrastructure or logistics. The user of the HemoCue Hb 801 System is responsible for the physical protection of the analyzer. -
Page 18: Troubleshooting
15 Troubleshooting Do not open the cover of the analyzer. Warranty is void if the analyzer has been opened. If analyzer parts are lost or damaged, contact the local distributor or HemoCue America. Main Actions Actions to solve most problems (if needed, perform all): Remove the microcuvette from the microcuvette holder. - Page 19 If the analyzer is continuously busy, turn the analyzer off and then on again. sudden analyzer Change or charge the battery/batteries, or make sure the adapter is shut down, or battery properly connected and that the USB cable is not damaged. indicator flashing analyzer not respond- Change or charge the battery/batteries, or make sure the adapter is...
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Page 20: Expected Values
16 Expected Values Due to a wide range of conditions (dietary, geographical, etc.), which affect normal values, it is recommended that each laboratory establishes its own normal range. For general guidance to normal reference values applicable to most healthy adults and children, see reference ranges below. - Page 21 23.2 Y = 1.07X - 0.91 0.96 1 = multicenter study, venous blood, compared to HemoCue Hb 301 2 = multicenter study, capillary blood, compared to HemoCue Hb 301 Non-interfering Substances The following substances have been tested according to CLSI EP07 at hemoglobin concen- trations 10±0.5 and 20±1.0 g/dL.
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Page 22: Limitations
18 Limitations a) Start the measurement immediately after filling the microcuvette. Do not let more than 40 seconds pass. b) Venous samples (K EDTA or Li-Heparin) can be stored and transported for up to 24 hours in room temperature or refrigerator, before measuring. c) The following substances have been tested according to CLSI EP07 to determine the inter- fering concentration. -
Page 23: Safety And Compliance
19 Safety and Compliance The HemoCue Hb 801 System complies with the IVD Medical Device Directive 98/79/EC and carries the CE mark. HemoCue AB hereby declares that this product is compliant with the essential requirements and provisions of the Radio Equipment Directive (RED) 2014/53/EU and ROHS directive 2011/65/EU. -
Page 24: References
Bluetooth ® SIG, Inc. and any use of such marks by HemoCue AB is under license. Other trademarks and trade names are those of their respective owners. Copyright © 2018 HemoCue AB... -
Page 25: Technical Specifications
(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 overvoltage category analyzer mode continuous... - Page 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...
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