1 / 37

HumaMeter A1c

HumaMeter A1c. HumaMeter A1c. Product Overview HbA1c and Diabetes Performing a Test Basic Maintenance Summary. Product Overview. HumaMeter A1c is a revolution in HbA1c measurement: It combines market-leading PoC analyser accuracy with low cost, easy to use technology.

march
Download Presentation

HumaMeter A1c

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. HumaMeter A1c

  2. HumaMeter A1c Product Overview HbA1c and Diabetes Performing a Test Basic Maintenance Summary HumaMeter A1c

  3. Product Overview HumaMeter A1c is a revolution in HbA1c measurement: It combines market-leading PoC analyser accuracy with low cost, easy to use technology. HumaMeter A1c

  4. HumaMeter A1c Analyser Door with automatic switch Large backlit display Reagent cartridge Barcode scanner HumaMeter A1c

  5. Product Features HumaMeter A1c

  6. Technical Information Boronate Affinity methodology (interference free) Traceable to the IFCC reference method Imprecision: CV <3% (at 7% A1c) Measuring range: 4-15% A1c (20-140 mmol/mol) Unaffected by Hb variants (which do not result in reduced erythrocyte life span) User selectable dual reporting.Choose from % DCCT, IFCC mmol/mol, % JDS, eAG mg/dL or eAG mmol/L Optional printer HumaMeter A1c

  7. Small sample size required (4 μL) Fast measuring time (approx. 4 minutes) Reagent stability of 12 months at 2-8 °C; thereof up to 90 days @ room temp. (uncooled)* Sold in compact boxes of 50 (2 * 25) reagent cartridges with 50+ sample sticks; imprinted calibration barcode *18 – 25°C HumaMeter A1c Reagent Test Cartridges HumaMeter A1c

  8. Components and Accessories Ordering information: Optional accessories: • Spare parts: • There are no serviceable parts. If broken or lost, the following parts can be exchanged by the user: • Barcode scanner HumaMeter A1c (Ref. No. 16083) • Printer cable HumaMeter A1c (Ref. No. 16081/1) HumaMeter A1c

  9. HbA1c and Diabetes

  10. HbA1c and Diabetes Diabetes mellitus (commonly : ”Diabetes”): Diseases in which a person has high blood sugar (=Glucose) Reasons: Body produces not enough insulin or cells do not respond to the insulin produced. 2 Types: Type 1 diabetes (Insulin-dependent diabetes):Caused by loss of insulin-producing beta cells in pancreas.Usually young people. Type 2 diabetes (Non-insulin dependent diabetes):Results from insulin resistance (cells fail to use insulin properly).Sometimes combined with insulin deficiency. Typically in adults over 40 and overweight patients. HumaMeter A1c

  11. HbA1c and Diabetes Causes of Diabetes HumaMeter A1c

  12. HbA1c and Diabetes Signs and Symptoms of Diabetes HumaMeter A1c

  13. HbA1c and Diabetes Blood Glucose level is used for DIABETES Diagnosis & DIABETES Monitoring Diabetes: High blood sugar (=Glucose) HumaMeter A1c

  14. HbA1c and Diabetes Functions of Blood: Transport→ …of oxygen, nutrients, electrolytes, hormones and enzymes throughout the body Regulation→ … of fluid and electrolyte balance, temperature Protection→ …against bacteria, viruses, toxins Wound healing → …through clotting mechanism HumaMeter A1c

  15. HbA1c and Diabetes Components of Blood HumaMeter A1c

  16. HbA1c and Diabetes Hemoglobin and Glucose Glucose rapidly diffuses into RBC by facilitated diffusion. N terminal valine of hemoglobin alpha chain is available for irreversible glycation:Hemoglobin Hb → HbA1c Hb glycation level (= HbA1c level) is proportional to glucose concentration in plasma ! HumaMeter A1c

  17. HbA1c and Diabetes WHY HbA1c? RBC lifespan: 8-12 weeks→ HbA1c concentration indicates average blood glucose level over previous 8-12 weeks HbA1c testing - one of the best ways to ensure good diabetes control as it reports an overall level, not a snap-shot concentration HbA1c is not the same as a glucose measurement! Note: A patient’s HbA1c level is affected e.g. by RBC lifespan, which may be decreased in some conditions. HumaMeter A1c

  18. Summary HbA1c principle - RBC Red blood cells, Hemoglobin & Glucose RBC: Uptake, transport and release of oxygen Oxygen bound to Hemoglobin Hb Glucose easily moves between blood & RBC Irreversible Glycation (=binding of Glucose) of Hb Glycated Hb - HbA1cLevel of Glycation ~ Glucose in plasma RBC lifespan = 8-12 weeks: HbA1c concentration indicates average blood glucose levels last 8-12 weeks HbA1c reports an “overall glucose concentration”, not only a “snap-shot concentration”!HbA1c testing - the best way to ensure good diabetes Discovery & Control!

  19. HbA1c and Diabetes HbA1c LEVELS Commonly used clinical ranges for glycated hemoglobin (HbA1c) are: • Normal: < 5.7% • Pre-diabetes: 5.7% - 6.4% • Diabetic: 6.5% or higher Targets should be set for each individual, taking into consideration their risk of severe hyperglycaemia, cardiovascular status and co-morbidities. Note: The American Diabetes Association recommends a goal of less than 7% DCCT (53 mmol/mol IFCC) for effective management of diabetes and to minimize long-term diabetic complications. HumaMeter A1c

  20. Performing a Test

  21. Performing a Test A Few Easy Steps … plus fool-proof display-guidance Scan lot calibration, remove cartridge foil and insert into analyser. Press reagent bead into the cartridge. Take blood sample. Insert into cartridge and snap the stick. Close lid. Results in 4 minutes. HumaMeter A1c

  22. Performing a Test Set Up Make sure a tray of cartridges & the analyser are equilibrated to working temperature(room temperature) Scan lot calibration barcode Remove foil lid from cartridge Place cartridge into analyser When prompted, press reagent bead into the cartridge with blunt end of the sample stick HumaMeter A1c

  23. Performing a Test Preparing to Take a Blood Sample Make sure your patient sits comfortably. There should be good blood circulation in the hand from which the sample is to be taken. The hand should be warm and relaxed. If in doubt, warm the hand in lukewarm water. HumaMeter A1c

  24. Performing a Test Stimulating Blood Circulation Lightly massage the fingers in order to stimulate the circulation. Operator should wear protective gloves. Middle or ring finger should be used for taking a sample. Patient should not wear a ring on the finger used for sampling. Disinfect the puncture site and allow it to dry completely. HumaMeter A1c

  25. Performing a Test Lancing the Finger Lance the finger on the side of the fingertip.This is less painful and the blood flow is better. Press lightly on the fingertip and puncture it with a lancet. A lancet that will create a blood flow of 10-20 μl is recommended. Blot away the first drop of blood. If necessary, press the finger gently again to get a second drop of blood which is large enough to fill the capillary . Avoid ‘milking’ the finger for blood. HumaMeter A1c

  26. Performing a Test Filling the Sample Stick Hold the sample stick with the blood collector and lightly touch the pointed tip on the surface of the blood droplet. Hold the stick in this position until it is filled completely with blood. Check that the blood collector cavity is completely filled and is free of air bubbles. Do not top-up the blood collector if it does not completely fill with blood. Instead, repeat the process with a fresh blood sample and stick. HumaMeter A1c

  27. Performing a Test Calibration Lot calibration is performed by scanning in the bar-code label found on of each cartridge box Lot calibration can be done: • When the analyser is idle • When the analyser requests it = When “Scan Lot Barcode” appears on the screen HumaMeter A1c

  28. Performing a Test Calibration (Cont.) Each reagent lot is directly calibrated to IFCC standards received from the European Reference Laboratory. Cartridge lot calibration is entered into the instrument by scanning the bar code on the box of reagents. Once the test is finished the results will be expressed in: • % HbA1c/total Hb traceable to DCCT • mmol/mol traceable to the IFCC standard Reporting methods JDS, Mono-S and eAG also can be selected from set-up menu HumaMeter A1c

  29. Performing a Test Measuring Procedure Insert the blood collector end of the sample stick into the cartridge that is in the analyser. Snap off the sample stick handle. Close the lid of the analyser. The result will appear on the screen within ~4 minutes. HumaMeter A1c

  30. Basic Maintenance

  31. Basic Maintenance Cleaning Procedure Clean the analyser with a non-abrasive lint free cloth. Use a mild detergent or commercially available disinfectant if necessary. Always turn off the analyser by unplugging the power supply before performing any cleaning operation. HumaMeter A1c

  32. Basic Maintenance Storage Turn off the analyser on a weekly basis for a minimum of 10 seconds so that when it is turned back on again, it will perform the internal self-checks. If the instrument is stored when not in use, ensure that the mains cord is not liable to damage or kinking. The analyser is calibrated by the manufacturer and there are no user-serviceable parts. Reagent shelf-life of up to 90 days (un-refrigerated). Total Reagent stability of 12 months at 2-8 °C. HumaMeter A1c

  33. Competition

  34. Competitor analysis I

  35. Competitor analysis II

  36. Competitor analysis III

  37. RECAP Name some of the most common causes of diabetes. Name some of the symptoms of diabetes. What does HumaMeter A1c measure? Why must the reagent cartridges be removed from storage 40 minutes before use? Which fingers should be used for taking a blood sample? How long does HumaMeter A1c take to provide results? HumaMeter A1c

More Related