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HumaMeter A1c

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Page 1: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1c

Page 2: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 2

HumaMeter A1c

1. Product Overview

2. HbA1c and Diabetes

3. Performing a Test

4. Basic Maintenance

5. Summary

Page 3: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 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.

Page 4: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 4

HumaMeter A1c Analyser

Large backlit display

Door with automatic switch

Reagent cartridge

Barcode scanner

Page 5: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 5

Product Features

AccessoriesOptional label

printer

Page 6: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 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

Page 7: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

• 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 A1cPage 7

HumaMeter A1c Reagent Test Cartridges

Page 8: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 8

Components and Accessories

Product Included Ref. No. HumaMeter A1c analyzer Analyzer, User Manual (GB, F, E, RUS), Barcode

scanner, Power supply16080

HumaMeter HbA1c reagent kit 50 test cartridges, 50 sample sticks, 1 IFU, calibration barcode

16085/50

HumaMeter HbA1c control 16086

Product Ref. No.

Printer HumaMeter A1c 16081

Printer label rolls HumaMeter A1c (320 labels) 16082

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)

Ordering information:

Page 9: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HbA1c and DiabetesBild durch Klicken auf Symbol hinzufügen

Page 10: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 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.

Page 11: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 11

HbA1c and Diabetes

Causes of Diabetes

High Blood Pressure

High blood triglyceride (fat) levels

Poor diet (processed simple carbs and sugars)

Sedentary lifestyle

Obesity or being overweight

Increasing age

Pregnancy (gestational diabetes)

Pancreatitis

Page 12: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 12

HbA1c and Diabetes

Signs and Symptoms of Diabetes

Excessive thirst

Frequent urination

Blurry vision

Sedentary lifestyle

Tingling or numbness in the hand and feet

Wounds that don’t heal

Extreme unexplained fatigue

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HumaMeter A1cPage 13

HbA1c and Diabetes

Blood Glucose level

is used for

DIABETES Diagnosis & DIABETES Monitoring

Diabetes: High blood sugar (=Glucose)

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HumaMeter A1cPage 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

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HumaMeter A1cPage 15

HbA1c and Diabetes

Components of BloodRed Blood Cells (RBC) or Erythrocytes – ~99% of

blood cellsRBC contain hemoglobin, an oxygen-carrying

protein. Oxygen binds to hemoglobin in lungs and is the transported to the tissues.

White blood cells (WBC) or Leukocytes Initiate immune responses, < 1% of blood cells.

Platelets (PLT) or ThrombocytesCrucial for blood clotting & wound healing.

PlasmaYellow fluid that carries all blood cells; makes up

~55% of blood.

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HumaMeter A1cPage 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 !

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HumaMeter A1cPage 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.

Page 18: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

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 - HbA1c

Level 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!

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HumaMeter A1cPage 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.

Page 20: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

Performing a Test

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HumaMeter A1cPage 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.

Close lid.

Results in 4 minutes.

Take blood sample.

Insert into cartridge and snap the stick.

Page 22: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 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

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HumaMeter A1cPage 23

Performing a Test

Preparing to Take a Blood Sample

1. Make sure your patient sits comfortably.

2. There should be good blood circulation in the hand from which the sample is to be taken.

3. The hand should be warm and relaxed. If in doubt, warm the hand in lukewarm water.

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HumaMeter A1cPage 24

Performing a Test

Stimulating Blood Circulation

1. Lightly massage the fingers in order to stimulate the circulation.

2. Operator should wear protective gloves.

3. Middle or ring finger should be used for taking a sample. Patient should not wear a ring on the finger used for sampling.

4. Disinfect the puncture site and allow it to dry completely.

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HumaMeter A1cPage 25

Performing a Test

Lancing the Finger

1. Lance the finger on the side of the fingertip.This is less painful and the blood flow is better.

2. Press lightly on the fingertip and puncture it with a lancet.

3. A lancet that will create a blood flow of 10-20 μl is recommended.

4. Blot away the first drop of blood.

5. If necessary, press the finger gently again to get a second drop of blood which is large enough to fill the capillary .

6. Avoid ‘milking’ the finger for blood.

Page 26: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

HumaMeter A1cPage 26

Performing a Test

Filling the Sample Stick

1. Hold the sample stick with the blood collector

and lightly touch the pointed tip on the surface

of the blood droplet.

2. Hold the stick in this position until it is filled

completely with blood.

3. Check that the blood collector cavity is

completely filled and is free of air bubbles.

4. 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.

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HumaMeter A1cPage 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

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HumaMeter A1cPage 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

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HumaMeter A1cPage 29

Performing a Test

Measuring Procedure

1. Insert the blood collector end of the sample stick into the cartridge that is in the analyser.

2. Snap off the sample stick handle.

3. Close the lid of the analyser.

4. The result will appear on the screen within ~4 minutes.

Page 30: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

Basic MaintenanceBild durch Klicken auf Symbol hinzufügen

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HumaMeter A1cPage 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.

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HumaMeter A1cPage 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.

Page 33: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

CompetitionBild durch Klicken auf Symbol hinzufügen

Page 34: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

Competitor analysis I

Page 34

   Axis Shield Nycocard

Infopia Clover Hemocue 501 (OEM of Clover)

Boditech i-CHROMA

Ceragem Labona Check™

Ceragem Cera-Stat 2000

Bio-Rad IN2ITHumaMeter A1c

CERTIFICATIONNGSP and IFCC

certification

 

NGSP certified Barcode calibration

NGSP certified Barcode calibration NGSP certified

NGSP and IFCC certification NGSP certified NGSP certified

METHODOLOGY

Boronate Affinity

Boronate Affinity reflectance

Boronate Affinity Boronate Affinity

Immunological

Boronate Affinity with optical reflectance

Boronate Affinity with optical reflectance

Boronate Affinity

Fluorescence Quenching

Inverse Amperometry

Inverse Amperometry Chromato-graphy

TIME TO RESULT <4 mins 3 mins 5 mins 5 mins >12 mins 3 mins 3 mins 10 mins

MEASUREMENT RANGE % A1C 4 - 15% 4 - 15% 4 - 14% 4 - 14% 4 - 15% 4 - 15%

HbA1c: 4 % - 15 %, Hemoglobin: 5 - 26

g/dL 4 - 14%SAMPLE VOLUME 4 µl 5 µl 4 µl 4 µl 5 µl 5 ul 5 ul 10 ul

IMPRECISION, CV AT 7% A1C

<3% 8.5% <3% <3% <5% 2.8 - 3.8% No info <4%

SPECIMEN TYPE Capillary & venous Finger & venous Capillary Capillary Capillary Capillary & venous Capillary & venous Capillary & venous

AFFECTED BY HB VARIANTS*

No No No No Yes No No No

REAGENT TYPE Cartridge: Test disc: Cartridge: Cartridge: Lateral flow stripSample capillary with hemolysis

vials or step dropper, 2 liquid

reagents, pipette, cartridge

Sample capillary with hemolysis

vials or step dropper, 2 liquid

reagents, pipette, cartridge

Cartridge:

 

Ready to use Add reagents to sample and disc

Shake reagents before taking

sample

Shake reagents before taking

sample

 

Ready to use

                 

Page 35: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

Competitor analysis II

Page 35

   Axis Shield Nycocard Infopia Clover

Hemocue 501 (OEM of Clover)

Boditech i-CHROMA

Ceragem Labona Check™

Ceragem Cera-Stat 2000 Bio-Rad IN2IT

HumaMeter A1c

MEMORY: PATIENT & QUALITY CONTROL 7,000 P & QC Last Patient 200 P 200 P   300 results 300 results 200 P & QC

REAGENT STORAGE

12 months @ 2 - 8°C; thereof 90 days at room temperature

2 - 8°C 90 days at room temperature Room temperature Room temperature 2 - 8°C 20 months 2 - 8°C

 

2 - 8°C 30 days at room temperature

OPERATING CONDITIONS 18 - 30°C 18 - 30°C 17 - 32°C 17 - 32°C 10 - 40°C

20 - 25 °C; Humidity:15 - 75%

20 - 25 °C; Humidity:15 - 75% 18 - 30°C

PATIENT/USER ID Yes No Optional Optional No NoNo (Patient ID manual entry)

No

PRINTER External No External External ExternalIntegrated thermal

printerIntegrated thermal

printer External

POWER AC AC

AC or DC9 AC or DC9

AC or 12v battery AC ACAC or 4 type AA

batteriesbattery battery

QUALITY CONTROL 2 levels 2 levels No No No 2 levels 2 levels2 levels Must be

diluted

SELF-TEST

During start up Optics check

before each test Calibration checkCheck cartridge

suppliedCheck cartridge

supplied Yes Yes Yes Optics check

PC INTERFACE USB port Serial portSerial port, USB

portSerial port, USB

port Serial port None NoneSerial port, USB

port

Page 36: HumaMeter A1c. Page 2 HumaMeter A1c 1.Product Overview 2.HbA1c and Diabetes 3.Performing a Test 4.Basic Maintenance 5.Summary

Competitor analysis III

Page 36

   Axis Shield Nycocard Infopia Clover

Hemocue 501 (OEM of Clover)

Boditech i-CHROMA

Ceragem Labona Check™

Ceragem Cera-Stat 2000 Bio-Rad IN2IT

HumaMeter A1c

DEVICE CHARACTER-

ISTICSMultilingual

display

DCCT reporting only

Dual reporting Dual reporting DCCT reporting only

Reporting either DCCT or IFCC, touch screen

Reporting either DCCT or IFCC and Hb, touch

screen

Symbols and codes used on

display

Dual Reporting, user selectable units % DCCT,

mmol/mol IFCC, % JDS, eAG

mg/dl and eAG mmol/l

Requires multiple pipette steps

     

OTHER ANALYSIS NoCRP, D-Dimer, Micro Albumin

Blood glucose Optional module

PSA, D-dimer, HS-CRP, TROP No Hemoglobin No No

APPROVALS CE 510(k) 510(k)   CE CE CLIA waived

CLIA waived CLIA waived

MAXIMUM TIME PERMITTED AFTER BLOOD

7 minutes

   

30 seconds 5 minute 5 minute 10 seconds 10 secondsCOLLECTION

SIZE AND WEIGHT

95x205x135 mm 0.7kg

200x170x170mm 0.54kg

200x200x139mm 1.4kg

185x80x250mm 1.3kg

178x195x77mm 0.73 kg

178x195x77mm 0.73 kg

140x100x145mm 0.84kg

140x100x145mm 0.84 kg

OTHEREasy operation

Reagents stable at room

temperature for 1 month

Multi-step manual process

OEM of Clover

Reagents stable for 20 months

Multi step manual process

Updated nycocard with multi-step

manual processMulti-step manual

process

Noisy in use

Noisy in use

Bulky cartridges take up lots of

refrigerator space

Insert cartridge into machine then

insert reagent pack with sample (2 steps instead of

1)

Bulky cartridges take up lots of fridge space

1 cartridge must be assembled  

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HumaMeter A1cPage 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?