clinical evaluation the medonic m-series r product...

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The Medonic M-series Product specification Hematology analyzers beyond compromise Medonic M-series Clinical evaluation The Medonic M-series has been evaluated during 2005 by one of the most famous University Hospitals in Sweden. The M-series worked parallel with the Bayer Advia 120 for 964 samples. The evaluation has been made in accordance with the IVD directive. Hematology is in our blood For more product information: Please contact our local distributor www.medonic.se Distributor: RBC y = 1,0518x - 0,0368 R 2 = 0,9809 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 RBC Linjär (RBC) MCV y = 0,9951x + 0,7586 R 2 = 0,9662 40 50 60 70 80 90 100 110 120 130 40 60 80 100 120 140 MCV Linjär (MCV) RDW% y = 0,8468x + 1,7152 R 2 = 0,8957 10 12 14 16 18 20 22 24 10 15 20 25 ADVIA % Medonic M-series % PLT y = 0,9223x + 15,562 R 2 = 0,984 0 200 400 600 800 1000 1200 0 200 400 600 800 1000 1200 PLT Linjär (PLT) HGB y = 0,9666x + 0,1386 R 2 = 0,9815 50 70 90 110 130 150 170 190 50 100 150 200 HGB Linjär (HGB) WBC y = 1,0307x + 0,0517 R 2 = 0,9944 0 10 20 30 40 50 60 70 80 90 0 20 40 60 80 WBC Linjär (WBC) All LYMF y = 0,9825x + 0,2074 R 2 = 0,9356 0 1 2 3 4 5 0 1 2 3 4 5 ADVIA x10e9/l Medonic M-series x10e9/l All GRAN y = 1,029x - 0,0281 R 2 = 0,9931 0 5 10 15 20 25 30 35 0 5 10 15 20 25 30 35 ADVIA neutr +eos +baso x10e9/l Medonic M-series x10e9/l 1504158 Ref 02293 v2 2008-10

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Page 1: Clinical evaluation The Medonic M-series R Product ...medionics.co.ke/wp-content/uploads/2017/03/Medonic... · Clinical evaluation The Medonic M-series has been evaluated during 2005

The MedonicM-series

Product specification

Hematology analyzers beyond compromise

Medonic M-seriesClinical evaluationThe Medonic M-series has been evaluated during 2005 by one of the most famous University Hospitals in Sweden.The M-series worked parallel with the Bayer Advia 120 for 964 samples.The evaluation has been made in accordance with the IVD directive.

Hematology is in our blood

For more product information:Please contact our local distributor

www.medonic.se

Distributor:

RBC y = 1,0518x - 0,0368

R2 = 0,9809

0

1

2

3

4

5

6

7

0 1 2 3 4 5 6 7

RBCLinjär (RBC)

MCV y = 0,9951x + 0,7586R2 = 0,9662

40

50

60

70

80

90

100

110

120

130

40 60 80 100 120 140

MCVLinjär (MCV)

RDW%y = 0,8468x + 1,7152

R2 = 0,8957

10

12

14

16

18

20

22

24

10 15 20 25

ADVIA %

Medo

nic M

-serie

s %

PLT y = 0,9223x + 15,562R2 = 0,984

0

200

400

600

800

1000

1200

0 200 400 600 800 1000 1200

PLTLinjär (PLT)

HGB y = 0,9666x + 0,1386R2 = 0,9815

50

70

90

110

130

150

170

190

50 100 150 200

HGBLinjär (HGB)

WBC y = 1,0307x + 0,0517

R2 = 0,9944

0

10

20

30

40

50

60

70

80

90

0 20 40 60 80

WBCLinjär (WBC)

All LYMF

y = 0,9825x + 0,2074R2 = 0,9356

0

1

2

3

4

5

0 1 2 3 4 5

ADVIA x10e9/l

Medo

nic M

-serie

s x10

e9/l

All GRAN y = 1,029x - 0,0281

R2 = 0,9931

0

5

10

15

20

25

30

35

0 5 10 15 20 25 30 35

ADVIA neutr +eos +baso x10e9/l

Medo

nic M

-serie

s x10

e9/l

1504

158

Ref

022

93 v

2 20

08-1

0

Page 2: Clinical evaluation The Medonic M-series R Product ...medionics.co.ke/wp-content/uploads/2017/03/Medonic... · Clinical evaluation The Medonic M-series has been evaluated during 2005

Technical characteristicsInlets for all types of samples Required volumeOpen tube With automatic cleaning of probe <100 ulPre-dilute Separate inlet with built-in dispenser 20 ulClosed tube Available with automatic barcode scanning <250 ulMPA Micro capillary inlet without pre-dilution 20ulAutoloader Available with automatic barcode scanning <300 ul

Result presentationsStandard view with histogramsReference scales, parameters outside normal range will be highlightedSample list for analyzed samples

Easy handling

Touch screen with window-like software

QC functionLevey-Jennings plots and X-B functionAutomated input of reference values for controls and calibrator by barcode

Patient profilingSet up your own data for different patient profiles, up to 8 different profiles.

External Keyboard

For those who would rather use a normal keyboard than touch screen, the Medonic M-series

has been equipped with connector for normal PC-keyboards

Model specification

Instrument model M16/20 M16M/M20M M16C/M20C M16S/M20S

No. of parameters 16/20 16/20 16/20 16/20

Analyzing speed open tube inlet* 50 sec 50 sec 50 sec 50 sec

Micro Pipette Adapter No Yes Yes Yes

Screen BW Color Color Color

QC software Yes Yes Yes Yes

Built-in Mixer No Yes No No

* Analyzing speed measured from start of aspiration to result presentation on screen.

Specification of parameter settings for the M-series16 parameters instrument: WBC, HGB, RBC, PLT, HCT, MCV, RDW, MPV, MCH, MCHC, LYM%, LYM, MID%, MID, GRAN%, GRANAdditional for 20 parameters: RDW, PDW, PCT, LPCR

Precision

Display range Units CV%

WBC 0-99,9 103 /ul <1,8%

RBC 0-14 106/ul <1,1%

MCV 15-250 fl <0,3%

PLT 0-1999 103 /ul <3,3%

HGB 0-99,9 g/dl <1,0%

Typical values measured over 10 Boule Control samples, measured in open tube mode and under good laboratory conditions.

Maintenance-free operationMedonic M-series is maintenance-free for the operator, only regular preventive service is required for trouble-free operation.

Dimensions & WeightHxWxD 410x290x460 mm. Weight ~18 kg

The SystemReagents

New Reagents and new DualPackThe Medonic M-series has a new protected reagent system which includes only diluting and lyzing reagents. And, as an alternative to the bulk containers holding 20 and 5 liters of reagents, there is now also a handy 9kg DualPack with reagents for 200 samples.

Product info

Art no, Decription Size

Reagents M-series1504128 M-Series DualPack 200 cycles (9 kg)

1504122 Boule M-series Diluent 900 cycles (21 kg)

1504123 Boule M-series Lyse 900 cycles (6 kg)

Control productsAs one of the most important elements of a complete hematology system provided by Boule Medical AB, Boule Cal and three-level Boule Con, up to 16 parameters, insure quality performance of the Boule hematology analyzer beyond compromise.

Product info

Art no, Decription Size

Control blood Boule CON 1504019 Normal 16 parameters 1x4,5 ml

1504020 Low abnormal 16 parameters 1x4,5 ml

1504021 High abnormal 16 parameters 1x4,5 ml

1504022 Low, normal, high 16 parameters 6x4,5 ml

1504023 Normal 16 parameters 6x4,5 ml

1504071 Normal 8 parameters 6x3 ml

1504073 Low, normal, high 8 parameters 6x3 ml

Calibrator Boule CAL1504025 Calibrator 1x3 ml

1504045 Calibrator 2x3 ml

Cleaning

Boule Cleaning KitMaintaining high quality performance of hematology analyzers. The Boule Cleaning kit is a unique multi-functional cleaner designed for use in Medonic hematology analyzers. These cleaning fluids will, in three steps, thoroughly clean and relubricate your analyzer completely, thereby prolonging the life of the components and minimizing the risk of bacterial growth and background problems.

Product info

Art no, Decription Size

1504111 Boule Cleaning kit 3x450 ml

MicrocapillariesBoule plastic microcapillaries are specially designed for the MPA system to prevent the risk of broken glass in the measuring system. The capillaries are coated with K2EDTA to mini-mize the risk for clots in the sample.

Product info

Art no, Decription Size

1070030 Boule MPA plastic micro pipettes 10x 100