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ELite 3

2.0
: 10- -2012

. 4

1.
1.1.

1.2.

..............................................................................................................4

1.2.1.

..............................................................................5

1.2.2.

... 6

1.2.3.

....................................................................................8

1.2.4.

...8

1.3.

12

1.4.

12

1.4.1.

.. 13

1.4.2.

... 13

1.4.3.

. 13

1.5.

.. 13

1.6.

14

1.7.

15

.16

2.

2.1.

16

2.2.

16

2.2.1.

16

2.2.2.

.17

2.2.3.

..17

2.2.4.

18

2.2.5.

18

2.2.6.

... 18

2.2.7.

.. 19

2.3.

3.

. 19

2.3.1.

, 21

2.3.2.

. 22

2.3.3.

22

2.3.4.

. 23

2.3.5.

... 23

24

3.1.

24

3.1.1.

...24

3.1.2.

.. 24
2


3.1.3.

.. 27

4.

4.1.

27

4.2.

(HGB) 27

4.3.

.. 28

4.4.

.. 29

30

5.

5.1.

5.1.1.

... 33

5.1.2.

() 33

5.1.3.

.. 36

5.1.4.

. 37

5.1.5.

39

5.1.6.

. 39

5.1.7.

.40

6.1.

.. 42

6.2.

/ .. 43

6.3.

. 44

6.4.

45

7.

. 46

7.1.

..46

7.2.

47

7.2.1.

.. 48

7.2.2.

. 48

7.3.

.50

7.3.1.

. 50

7.3.2.

...51

7.3.3.

QC 51

7.3.4.

52

53
8.1.1.

.53

8.1.2.

. 53

8.2.

9.

30

.. 41

6.

8.

. 25

...54

8.2.1.

55

8.2.2.

. 55

56
9.1.

..56
3


9.2.

. 58

9.3.

. 58

9.3.1.

. 59

9.3.2.

.. 60

9.3.3.

60

9.3.4.

. 61

9.4.

.61

9.5.

. 62

10. 66
10.1.

... 66

11. . 68
11.1.

68

11.2.

68

11.2.1.

, .. 68

12. ()69
13. .70
14. A 71
14.1.

72

14.1.1.

.. 72

15. 74

1.
1.1.
ELite 3
, in vitro .

.

1.2.
,
,
, .
,
- START.
( )
( 58 ).
1000
.
(QC).
USB .
, , USB
(RS-232), .

: ,
,
.


.

1.2.1.

80
(WBC) .
.
, ,
. .
20 ,
3 ,

- 25 :
WBC ()
RBC ()
HGB ()
HCT ()
MCV ( )
MCH ( )
MCHC ( )
PLT ()
LYM ()
MON ()
GRA ()
LYM% (% )
MON% (% )
GRA% (% )
RDW-SD (
)
RDW-CV ( )
PDW-SD (
)
PDW- CV (
)
MPV (c )
PCT ()
3 :
WBC-3 part ( ,
)
RBC ( )
PLT Histogram ( )
* RDW PDW : CV (
) SD ( ).

.

1.2.2.


, .
.
''''
. MSDS .
Erba Cleaner
.
+15 +30C.
.
120 .
.
, .
, , 12
.

Erba Diluent-Diff
: 50003763, 20
,

. 36
.

< 1.5 %
< 1.0 %
< 0.5 %
< 0.5 %

Erba Lyse-Diff
: 50003764, 1
3
(WBC)
(HGB). 48
.

< 3.5 %
< 1.0 %
< 0.5 %
< 0.5 %

Erba Cleaner
: 50003767, 1 L
.
48 .

< 1.0 %
< 1.0 %
< 0.5 %
< 0.5 %

Erba Hypoclean CC
: 50003773, 100

15 .

< 1.0 %
< 12.0 %
< 3.5 %
< 0.5 %

Hypoclean CC (
ELite 3).
ELite 5 , .
EU 1999/45/EC:
, R 34
R 31
:
C

1.2.3.

,
.
:
,
.
/ .
, .


.
,
7.1.2.

1.2.4.

ELite 3
. ,
, ,
.

, ().
7.2.


1 2 .

LCD


USB
socket

1.

USB A

USB B

conn


(,
)

grounding

2.

10

:
-

(
)

, ,

().
230V 115V,
CE UL.
!
, :
GlobeTek Electronics Corp. Model ID: GT-81081-6012-T3

11

1.3.
ELite 3 :
: , , ,
, ,

.
: ,
, .
: : -, Start,
, ( )
() .

1.4.
, 12.
:


a.

b.

c.

d.
.
f.

25 (K3-EDTA)
, 4
( ).
25 ( ) 4
(RB)
HGB

(WBC), .

.
WBC, HGB , 4
( 25
).
RBC PLT

,
.
1.

1:160

RBC

1:32 000

WBC 1:196
(
)

:
WBC
12
HGB

RBC/PLT

12

12

1.4.1.

START
.

(//) LED ()
START .
.

LED color

.
START.

,
3 : 3 .

.
.


.
.

1.4.2.

: 320 x 240 , ,
, .

1.4.3.

.

. ,
// .

1.5.

Erba Hematology Control -
( ). ,
.
.

13

1.6.
.
-E
ELite 3 - pack:

ELITE 3
ELITE 3 ELITE 3
( ):
()
()
()
()

,
,
(20 )

( 230)

14

1.7.

25 3

50
2
, ,
70 (RBC/PLT), 100 (WBC)
80 /

:
(CV)

3
WBC
3%
3%
<1%
4.0-20.0
10 /
6
RBC
3%
2%
<1%
4.0-15.0
10 /
HCT
3%
<1%
25.0-50.0
%
3%
MCV
2%
1%
N/A
60-100

HGB
2%
2%
<1%
9-16
/
3
PLT
5%
5%
<3% <20
200-900
10 /



(), , , , .

,
()

.

,

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( ) 1-, 2- 3- ,

() RBC, MCV, RDW, WBC, HGB, PLT, MPV.


.

,
START, LED

, , , , , ,
,

1000 , RBC, PLT, WBC 3-



USB B

USB

USB A USB

USB HP (DeskJet, LaserJet, PCL3, PS,
LIDIL)

, 58

320x240 -, ,
().

- + START,
// LED

USB USB A

12VDC, 5A, 60W

, 100-120 200-240 VAC, 5060Hz

5986 F (1530 C). 77 F (25 C)
( x x )
12.6 x 10.2 x 14.4 (320 x 260 x 365 )

12

15

2.
2.1.

ELite 3. ,
, .
,

, .
:
. ,
.
: .

2.2.
ELite 3 15-30C
45% .. 85%.
25C.

. 10C,

.
18-30C.
.
(,
, , , ..).
3000 (9000 )
, .
2 2
.


.

2.2.1.

ELite 3 ,
.
.

16


:
.

2.2.2.

.
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. 0.2 (8 )
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2.2.3.

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CE


17

2.2.4.

USB

, USB
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USB B ( )
USB A-B USB
( )

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7.3.2.
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2.2.5.

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2.2.6.

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18

2.2.7.


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2.3.
1. .
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2- .


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2.
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USB A
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ELite 3.
AC ( ).
4.
USB B
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, .
5.
.

19


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6.

. ELite 3,
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(

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5.

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20

2.3.1.

,
a. ( ,
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).
b.
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LED .

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(SW) .

SW ,
.


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5
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21

2.3.2.


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(Admin)
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2.3.3.


1 . ,
100 .
.


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22

,
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2.3.4.

(
..)
.

2.3.5.

Biohazard

,
.

Corrosive

Warning

Sharp needle
warning

23

3.
3.1.

.

,
, .

3.1.1.


.

, /. ,
,
.

3.1.2.

,
( , ,
).
. ( ,
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, , .

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24

3.1.3.

(Measure)

(Database)

(Maintenance)

(New)
(Re-run)
(Blank)
(Print)
Discard
/
(Detail / view)

(Edit record)
(Print)
(Filter)
(Trends)
(Manage)
(Cleaning)

(Cleaning)
(Hard
cleaning)

(Drain chamber)

(Calibration)

(Factors)
(Measure)
(History)

(Prediluted)

(Factors)
(History)


(Quality control)

QC1 (QC1)
QC2 (QC2)
QC3 (QC3)
QC4 (QC4)

(References)
(Measure)
(Diagram)

(Database)

QC5 (QC5)
QC6 (QC6)

(Diagnostics)


(Reagent status)
(Settings)

(Printer)


(Device
information)
(Self test)
(Volumes)
(Device)
(Printout)
(Format)
(Header)


(General settings)
(Measurement)

(Units)

(Normal ranges)
(Profile)
(Settings)


(Date and time)

/
(Result / Calibration)

/
(Set Date / Time)

25


(Date Format)

(Exit)

Logout

(Shut down)

(Add new user)

(Remove User)

(Preparing for shipment)


(Auto login set)


(User Management)

(Edit / View user)

.
.

26

4.
4.1.
( )


- .

Internal electrode

Aperture
Blood cell suspension
External electrode

7.
, ,

.


.
().
.
(WBC, RBC, PLT
). (
, ),
().

4.2. (HGB)

.
. ,
.
.
Erba Lachema
. , .
,
.
. (Erba Lachema s.r.o.)
,
.

27

4.3.
ELite 3 20 ,
. ,
.
.
WBC
(cells/l, /)
Red Blood Cells RBC
(cells/l, /)
- HGB
(g/dl, /, mmol/l)
- MCV
(fl)
HCT
(%, -)

MCH
(pg, fmol)

MCHC
(g/dl, /, mmol/l)

RDW-SD
(fl)

PDW-SD
(fl)

RDW-CV
()

PDW-CV
(. )
PLT
(cells/l, /)
MPV
(fl)
PCT
(%, )
3
:
LYM, LYM% :
MON, MON% :

NEU, NEU%:


WBC = WBCcal x counted WBC (cells/l, /)

RBC = RBCcal x counted RBC (cells/l, /)
540 ;

HGB = HGBcal x (HGBmeasured HGBblank)
,
RBC .
RBC MCV .
HCT% = RBC x MCV x 100
HCT = RBC x MCV
,
RBC HGB .
MCH = HGB / RBC
HGB HCT .
MCHC = HGB / HCTabsolute

HGB (g/dl, / or mmol/l)

20%

xDW-SD = RDW cal x (P2 - P1) (fl),


xDW-CV = RDW cal x 0.56 x (P2 - P1) / (P2 + P1)
CV 0.56 60%

()
PLT = PLTcal x counted PLT (cells/l, /)
,
PLT
PLT MPV
PCTpercentage = PLT x MPV x 100
PCTabsolute = PLT x MPV
,
WBC:


WBC.

28

4.4.

.
,
.
,
E ().
, .
,
. 5.3.4 .
:

WBC

0...100

150

10
/

RBC

0...15

20

10
/

PLT

0...700

1000

10
/

HGB

0...250

400

HCT

0...100

MCV

30...150

() fl

MPV

3...30

() fl

12

2.
1:5
:

WBC

2200

300

10
/

RBC

130

40

10
/

PLT

1002000

3000

10
/

12

3.

29

&

5.
5.1.
, ,
,
,
. ,
.
K3-EDTA (), ,

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( RBC).
3 /. ,
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31

&

10. ,

1. !! ,
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2. .
3. START.

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32

&


5.1.1.

K3-EDTA .
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5.1.2.

()

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.

33

&
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34

&
(WBC) : .
, RBC
PLT .
WBC 3 (WBC, LYM, MON, GRA, LYM%,
MON%, GR%) HGB.



3 .
(, , ...,
.
(/
) - Patient limits menu (Settings / Measurement Limits).

(+0.1, +0.2ml)
RBCs WBC ,
WBC LYM.
(-0.1, -0.2ml) WBC
(),
WBC ( ).
WBC.

+
.
.


2 ,
. ELite 3, ,
.
.
(
) .
,
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35

&

, ,
, START .

!

, !

5.1.3.

,
,

, WBC, RBC, PLT


.
,

.
,

.

36

&

5.1.4.


, .


.
WBC HGB.


WBC 3

.
.

HGB ,
HGB

. HGB
,
WBC: .
, .

WBC ,

WBC

,
.

.


WBC

,
.

.


RBC
WBC

RBC WBC. :
(
) RBCs
.

WBC
3- PLTs

PLTs .
.
(, )
.

, WBC NEU -
.
.
RBC-WBC

RBCs

WBC .

.
MON NEU - VALID, WBC LYM

RBCs.
WBC
.
. ,
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( ) ,
.

4.
WBC/HGB

37

&
RBC PLT .

PLT/RBC

RBC

PLT / RBC

RBC/PLT

PLT , .
PLT
.
,
() .

RBC , , ,
RBC
p.

.

.

RBC.
.
PLT RBC ,
PLT/RBC .
, C .

5.
RBC/PLT
:
() (c, C), (E).
.

(!)


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:
PLT (PLT
),


. -
, (-),
, (+) (
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38

&

5.1.5.

.
, : +.

. .
.

: WBC RBC HGB HCT MCV MCH
MCHC PLT PCT MPV PDWs PDWc RDWs
RDWc LYM MON GRA LYM% MON%
GRA%
:
,
. - , .

5.1.6.


. :
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(, , , ).
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3 :
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3. Blank exceeds acceptability .

1.

2. !

HGB

0-10 /

10 - 25 /

WBC

0 - 0.5 x10 /

0.5 - 1.0 x10

3. E ()
> 25 /
3

> 1.0 x103 /


39

&
/
3

PLT

0 - 25 x10
/

25 - 50 x103
/

> 50 x103 /

RBC

0 - 0.05 x106
/

0.05 - 0.5 x106


/

> 0.5 x106 /

6.
.
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7.1.3).

5.1.7.


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46

7.2.

Erba - . QC
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7.2.1.

/

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0.81.2.
,

7.2.2.

,
.
.

,
.

/
,


:
48

WBC
RBC
HGB /
MCV
RDW CV
PLT
MPV
PDW CV
HCT
PCT

1.0
1.00
30
50
10
30
5
5
0.1
0

30.0
8.00
300
120
50
800
15
50
0.6
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7.
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.


START.

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7.3.

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7.3.1.

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START. ,
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QC.
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QC.
QC.

7.3.3.

QC

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51

7.3.4.

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QC.

: QC .
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52

8.

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8.1.1.

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8.1.2.


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8.2.
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8.2.1.


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8.2.2.


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9.


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57

9.2.
.


:

.
:
.
Export format:
.

.

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(Export format): (
A ):
(Simple text)
(Extended text)
(Advances text)
, .
.

9.3.

,
.

58

9.3.1.

,
.

HGB
PCT, HCT
RDW, PDW


cells/liter(/)
cells/(/)
grams/liter (/)
grams/deciliter (/)
millimols/liter (/)
(%),
.(ABS)
(SD),
(CV).

59

9.3.2.

.
range, : +.



.
. .
.
: WBC
RBC HGB HCT MCV MCH MCHC PLT
PCT MPV PDWs PDWc RDWs RDWc LYM
MON GRA LYM% MON% GRA%
: ,
.
,
.

9.3.3.


.
,
5 (,
) .

60

9.3.4.

/ /


.


.

-

.

.

.

/ /


HCT/PCT MCV/MPV
.

.

.

9.4.
.

.



.

.


o.

61

,
.
, . ,
.

9.5.
,
.
.

.

62

-
Admin.


,
.


. ,
.


- /.
.
.
.

.
: (Admin)
. (Admin ) .
: 0000

63


BASIC () :
(Measure)

Database ( )

(Maintenance)

(New)
(Re-run)
(Blank)
(Print)
(Discard)

(Options)

/
(Detail / table view)

(Edit record)
(Print)
(Filter)
(Trends)
(Manage)
(Cleaning)

(Cleaning)
(Hard
cleaning)
(Drain
chamber)

(Calibration)

(Factors)
(Measure)
(History)

(Prediluted)


Quality control (forbidden)

(Diagnostics)

(Factors)

(History)

(Device information)
(Self test)
(Service)


(Reagent status)

(Settings forbidden)

(Exit)

Logout
(Shut down)

(Preparing for shipment)

(User
Management)


(Add new
user)

(Remove User)
.

/
(Edit /
View user)

64


.
.

.

. .
.
,


.
Login (
)

.

.
Log In (. )

(
. )

.
.
.

.

65

10.
.

10.1.

,

:
* Database result(s) ( )
* Database ( )
* QC result ( -)
* QC result(s) ( QC)
* Calibration results ( )
* Last measured blank result (
)
* Last measured patient result ( ) (
)
* Last measured QC result (
QC)
* Device information and statistics (
)
* Self test result ( )
* Set parameters ( )
* Diagnostic flags (optional) ( ())

66

QC
QC

67

11.
11.1.

,
, , , ,
. , 5.3.2.

11.2.


.
.

11.2.1. ,

() .
.
.
::

12.
1. (Measurement).
.
2.
.
3. .

68

12. ()
ELite 3 - Reagent Lock
System ,
.
.
ErbaLyse-Diff (HK).



.
1. ErbaLyse-Diff.
HK .
2.
.
3.
ELite 3.
4. , (MaintenanceReagent
Status) (Reset).
5. .
6. HK .

!

,
.
, HK
3-6!

69

13.

70

14. A
(tab separated values)
(Export ) (Database menu).
Microsoft Excel Excel worksheets.
:
.
3 :
HT :
A.
<SAMPLEID>HT<DATE>HT<TIME>HT<WBC>HT<RBC>HT<HGB>HT<HCT>HT<MCV>HT<MCH>HT
<MCHC>HT<PLT>HT<PCT>HT<MPV>HT<PDWc>HT<RDWc>HT<LYM>HT<MON>HT<GRA>HT<LYM%>
HT<MON%>HT<GRA%>
: .
B.
<SAMPLEID>HT<DATE>HT<TIME>HT<WBC>HT<RBC>HT<HGB>HT<HCT>HT<MCV>HT<MCH>HT
<MCHC>HT<PLT>HT<PCT>HT<MPV>HT<PDWc>HT<RDWc>HT<LYM>HT<MON>HT<GRA>HT<LYM%>
HT<MON%>HT<GRA%>HT<Type>HT<WARNING>HT<RBC probe min>HT<RBC probe max>HT
<WBC probe min>HT<WBC probe max>HT<Lyse>
C.
<SAMPLEID>HT<DATE>HT<TIME>HT<WBC>HT<RBC>HT<HGB>HT<HCT>HT<MCV>HT<MCH>HT
<MCHC>HT<PLT>HT<PCT>HT<MPV>HT<PDWc>HT<RDWc>HT<LYM>HT<MON>HT<GRA>HT<LYM%>
HT<MON%>HT<GRA%>HT<Type>HT<WARNING>HT<RBC probe min>HT<RBC probe max>HT
<WBC probe min>HT<WBC probe max>HT<Lyse>HT<WBC Histogram>HT<WBC Marker 1>HT
<WBC Marker 2>HT<WBC Marker 3>HT<RBC Histogram>HT<RBC Marker 1>
where: -

WBC ill. RBC 256 0 255 HT

<WBC marker 1> WBC low marker

<WBC marker 2> LYM-MON marker

<WBC marker 3> MON-GRA marker

<RBC marker 1> PLT-RBC marker

0..255 WBC/RBC

71

14.1.

Elite 3
,

.
(
, )
- Erba Hypoclean CC 100
- .
:
1. Hypoclean CC 100
300
.
2. (
).
3. .
14.1.1.


. , 100
(
Hypoclean CC) .
.

,
.

.

72


,
, ,
, 100
Hypoclean CC .

,

.
,
: .
.

.

,
.
.

73

15.

(.+
.)

/ ()


200
37
34
34
34
34

5
0
1
1
1
1

7
6
0
0
0
0

29

26

31
13
9
41
51
16

0
0
0
0
0
0

2
0
0
5
0
0

: 80
: 0,7

74