Humameter a1c Product Presentation

HumaMeter A1c

HumaMeter A1c

1. Product Overview2. HbA1c and Diabetes3. Performing a Test4. Basic Maintenance

HumaMeter A1cPage 2

4. Basic Maintenance5. Summary

Product OverviewHumaMeter A1c is a revolution in HbA1c measurement:

It combines market-leading PoC analyser accuracy with lowcost, easy to use technology.

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HumaMeter A1c Analyser

Largebacklitdisplay

Door withautomaticswitch

Reagentcartridge

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cartridge

Barcodescanner

Product Features

Practical Fast andData

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Easy to useStep by step

instructions ondisplay

Multi-lingual menu

Innovative bloodcollector allowseasy sampling

PracticalCompact size

Weight: 0.7kg

Self-testing

Small sample size (4l)

Fast andaccurate

Results in4 minutes

Imprecision:CV

Technical Information

Boronate Affinity methodology (interference free)

Traceable to the IFCC reference method

Imprecision: CV

Small sample size required (4 L) 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

HumaMeter A1c Reagent Test Cartridges

50+ sample sticks; imprinted calibration barcode*18 25C

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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

Optional accessories:

Ordering information:

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Product Ref. No.

Printer HumaMeter A1c 16081

Printer label rolls HumaMeter A1c (320 labels) 16082

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)

HbA1c and Diabetes

HbA1c and DiabetesDiabetes 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.

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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.

HbA1c and DiabetesCauses 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

HbA1c and DiabetesSigns and Symptoms of Diabetes

Excessive thirst

Frequent urination

Blurry vision


Sedentary lifestyle

Tingling or numbness in the hand and feet

Wounds that dont heal

Extreme unexplained fatigue

HbA1c and Diabetes

Blood Glucose levelis used forDIABETES Diagnosis &DIABETES Monitoring

Diabetes: High blood sugar (=Glucose)


DIABETES Monitoring

HbA1c and DiabetesFunctions of Blood:

Transport of oxygen, nutrients, electrolytes,hormones and enzymes throughout the body

Regulation of fluid and electrolyte balance, temperature


Regulation of fluid and electrolyte balance, temperature

Protection against bacteria, viruses, toxins

Wound healing through clotting mechanism

HbA1c and DiabetesComponents of Blood

Red Blood Cells (RBC) or Erythrocytes ~99% of blood cellsRBC contain hemoglobin, an oxygen-carrying protein. Oxygenbinds to hemoglobin in lungs and is the transported to the tissues.

White blood cells (WBC) or LeukocytesInitiate 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.

HbA1c and DiabetesHemoglobin and Glucose

Glucose rapidly diffuses into RBC byfacilitated diffusion.

N terminal valine of hemoglobinalpha chain is available for


alpha chain is available forirreversible glycation:Hemoglobin Hb HbA1c

Hb glycation level (= HbA1c level)is proportional to glucoseconcentration in plasma !

HbA1c and DiabetesWHY HbA1c?

RBC lifespan: 8-12 weeks

HbA1c concentration indicates average

blood glucose level over previous 8-12weeks

HbA1c testing - one of the best ways to ensure


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 patients HbA1c level is affectede.g. by RBC lifespan, which may bedecreased in some conditions.

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 Glycated Hb - HbA1cLevel of Glycation ~ Glucose in plasma

RBC lifespan = 8-12 weeks: HbA1c concentration indicates average bloodglucose levels last 8-12 weeks

HbA1c reports an overall glucose concentration, not only a snap-shotconcentration!HbA1c testing - the best way to ensure good diabetes Discovery & Control!

HbA1c and DiabetesHbA1c LEVELS

Commonly used clinical ranges for glycated hemoglobin (HbA1c) are:

Normal: < 5.7% Pre-diabetes: 5.7% - 6.4% Diabetic: 6.5% or higher


Diabetic: 6.5% or higher

Targets should be set for each individual, taking into considerationtheir risk of severe hyperglycaemia, cardiovascular status and co-morbidities.

Note: The American Diabetes Association recommends a goal of less than 7% DCCT (53 mmol/molIFCC) for effective management of diabetes and to minimize long-term diabetic complications.

Performing a Test

Performing a TestA Few Easy Steps plus fool-proof display-guidance

Scan lot calibration,remove cartridge foil

and insert intoanalyser.

Press reagent beadinto the cartridge.

Close lid.

Results in 4 minutes.

Take blood sample.

Insert into cartridgeand snap the stick.


Performing a TestSet Up

Make sure a tray of cartridges & the analyserare equilibrated to working temperature(room temperature)

Scan lot calibration barcode


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

Performing a TestPreparing 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 lukewarmwater.

Performing a TestStimulating Blood Circulation

1. Lightly massage the fingers in order tostimulate the circulation.

2. Operator should wear protective gloves.3. Middle or ring finger should be used for


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

4. Disinfect the puncture site and allow it todry completely.

Performing a TestLancing 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 l is


3. A lancet that will create a blood flow of 10-20 l isrecommended.

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.

Performing a TestFilling the Sample Stick

1. Hold the sample stick with the blood collectorand lightly touch the pointed tip on the surfaceof the blood droplet.

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


completely with blood.

3. Check that the blood collector cavity iscompletely filled and is free of air bubbles.

4. Do not top-up the blood collector if it does notcompletely fill with blood. Instead, repeat theprocess with a fresh blood sample and stick.

Performing a TestCalibration

Lot calibration is performed byscanning in the bar-code labelfound on of each cartridge box

Lot calibration can be done:


Lot calibration can be done: When the analyser is idle

When the analyser requests it =

When Scan Lot Barcode appears

on the screen

Performing a TestCalibration (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 thebar 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 fromset-up menu

Performing a TestMeasuring Procedure

1. Insert the blood collector end of thesample stick into the cartridge that is inthe analyser.

2. Snap off the sample stick handle.


2. Snap off the sample stick handle.

3. Close the lid of the analyser.

4. The result will appear on the screenwithin ~4 minutes.

Basic Maintenance

Basic MaintenanceCleaning Procedure

Clean the analyser with anon-abrasive lint free cloth.

Use a mild detergent orcommercially available


commercially availabledisinfectant if necessary.

Always turn off the analyserby unplugging the powersupply before performing anycleaning operation.

Basic MaintenanceStorage

Turn off the analyser on a weekly basis for aminimum of 10 seconds so that when it is turnedback 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 andthere 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.

Competition

Competitor analysis I

Axis ShieldNycocard Infopia Clover

Hemocue 501(OEM of Clover)

Boditech i-CHROMA

Ceragem LabonaCheck

Ceragem Cera-Stat 2000 Bio-Rad IN2ITHumaMeter A1c

CERTIFICATIONNGSP and IFCC

certificationNGSP certified

Barcode calibrationNGSP certified

Barcode calibration NGSP certifiedNGSP and IFCC

certification NGSP certified NGSP certified

METHODOLOGY

Boronate Affinity

Boronate Affinityreflectance

Boronate Affinity Boronate Affinity

Immunological

Boronate Affinitywith opticalreflectance

Boronate Affinitywith opticalreflectance

Boronate Affinity

FluorescenceQuenching

InverseAmperometry

InverseAmperometry Chromato-graphy

TIME TO RESULT 12 mins 3 mins 3 mins 10 mins

MEASUREMENTHbA1c: 4 % - 15

%, Hemoglobin: 5 -

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RANGE % A1C 4 - 15% 4 - 15% 4 - 14% 4 - 14% 4 - 15% 4 - 15% 26 g/dL 4 - 14%SAMPLE VOLUME 4 l 5 l 4 l 4 l 5 l 5 ul 5 ul 10 ul

IMPRECISION, CVAT 7% A1C

Competitor analysis II



Boditech i-CHROMA

Ceragem LabonaCheck


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

REAGENTSTORAGE

12 months @ 2 -8C; thereof 90days at roomtemperature

2 - 8C 90 days atroom temperature Room temperature Room temperature 2 - 8C 20 months 2 - 8C

2 - 8C 30 days atroom temperature

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STORAGE temperature room temperature Room temperature Room temperature 2 - 8C 20 months 2 - 8C room temperature

OPERATINGCONDITIONS 18 - 30C 18 - 30C 17 - 32C 17 - 32C 10 - 40C

20 - 25 C;Humidity:15 - 75%

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

PATIENT/USER ID Yes No Optional Optional No NoNo (Patient IDmanual 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 upOptics 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

Competitor analysis III



Boditech i-CHROMA

Ceragem LabonaCheck


DEVICECHARACTER-

ISTICS Multilingualdisplay

DCCT reportingonly

Dual reporting Dual reporting DCCT reportingonly

Reporting eitherDCCT or IFCC,touch screen

Reporting eitherDCCT or IFCCand Hb, touch

screen

Symbols andcodes used on

display

Dual Reporting,user selectableunits % DCCT,

mmol/mol IFCC,% JDS, eAG

Requires multiplepipette steps

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% JDS, eAGmg/dl and eAG

mmol/l

OTHER ANALYSIS NoCRP, D-Dimer,Micro Albumin

Blood glucoseOptional module

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

APPROVALS CE 510(k) 510(k) CE CECLIA waived

CLIA waived CLIA waived

MAXIMUM TIMEPERMITTEDAFTER BLOOD

7 minutes 30 seconds 5 minute 5 minute 10 seconds 10 secondsCOLLECTION

SIZE AND WEIGHT

95x205x135 mm0.7kg

200x170x170mm0.54kg

200x200x139mm1.4kg

185x80x250mm1.3kg

178x195x77mm0.73 kg

178x195x77mm0.73 kg

140x100x145mm0.84kg

140x100x145mm0.84 kg

OTHER Easy operation

Reagents stableat room

temperature for 1month

Multi-step manualprocess

OEM of Clover

Reagents stablefor 20 months

Multi step manualprocess

Updated nycocardwith multi-step

manual processMulti-step manual

process

Noisy in use

Noisy in use

Bulky cartridgestake up lots of

refrigerator space

Insert cartridgeinto machine then

insert reagentpack with sample(2 steps instead

of 1)

Bulky cartridgestake up lots offridge space

1 cartridge mustbe assembled

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


Why must the reagent cartridges be removed from storage40 minutes before use?

Which fingers should be used for taking a blood sample? How long does HumaMeter A1c take to provide results?

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Humameter a1c Product Presentation