Clima

MC-15
IN VITRO

5
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

1. 3

2. 6

3. 13

4. 14

5. 16

6. 18

7. 19

8. 20

9. 25

10. 36

11. 2 ( 2) 42

12. 45

13. 45

14. CLIMA MC-15 46

15. CLIMA MC-15 47

16. 49
1: 49
2: 50
3: 50
4: 54
5: 57

17. 58

18. 59

2
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

1.
1.1.
,
Clima MC-15, .
.
.
- . 1.4
.

1.2.
.
in vitro,
.
RAL, DiaSys - ().
, .
.
, .

1.3.
RAL Tcnica para el Laboratorio, S.A.,
, , 1
, , .
.

1.4.
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.
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.
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.

3
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

1.5.

DECLARATION OF CONFORMITY

RAL, TCNICA PARA EL LABORATORIO S.A., located in Avda. Mare de Du

de Montserrat 51, 08970 Sant Joan Desp (BARCELONA), declares that
following
product:

RA115000 CLIMA MC-15

conforms to established requirements in RD 1662/2000, September 29 th

on diagnostic devices and established requirements in Electromagnetic
Compatibility CEI 61326-1-2 and Electrical Safety EN-61010-1.

Sant Joan Desp, September 3rd, 2003

General Manager

4
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

1.6.

IVD in vitro
SN
REF /

2002/96/EC
.
13 2005 .
.

1.7.

5
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

2.
Clima MC-15
,
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.
15 .
.
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.
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5 .
60 .
.
.

, -

30840-05.

6
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

7
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

8
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

9
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

10
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

11
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

12
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

3.
3.1.
-
: 320 680
: 340, 405, 500, 546, 578, 630 670
: 8
: , 20
:
: 0,001 1,5 340
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: 1%
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3.2.
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:
:
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: 0,5

3.3.
37 C, .

3.4.
, 64 , 110

: 220 / 50 , 200

: 58 57 20
: 20

13
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

4.
4.1.
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4.2.
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.

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.

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14
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

4.5.
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. :
(
).
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15
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

5.
5.1.
Clima MC-15 ,
.
,
.
:

Working ???
6 (2 .)

(2 .)




(10 .)

- RAL, Tcnica para el
Laboratorio, .

5.2.
Clima MC-15 ,
, ,
, . ,
15 25 C, .
.

5.3.
220 3-
. !
10 % ,
().

16
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

5.4.
CLIMA MC 15
. ,
.

, ,
11- . .
:
CLIMA MC 15
.
4 , 90 2
20 .
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:
.
() 11 .

.
, , .

17
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

6.
2- ,
,
:
08/01/05
09:05:30
1.
2.
3.
4.

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( 4, 90).
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1.
2.
3.
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5.
6. . .. .
7.
8. 8 ( )

9.
10.
11.
12. ( )

18
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

13.
14.
15. .
16. ( )

17. .
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7.
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.

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.
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19
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

8.
Clima MC-15 ()
. ().
.
:
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:
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2. . .
3. . .
4. . .
5. . .
6. . .
, .., . .

20
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

-1 ( 1):
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.
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1. 340 2. 405 3. 500
4. 546 5. 578 6. 630
7. 670 8. ---

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Clima MC-15
.

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.

0. M/ 1. /
2. / 3. /
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6. / 7. /

8. % 9. /
10./ 11. /
12. / 13. /
14. KAT/ 15. /

16. / 17. %

, ,
: ( ) . :

: ( )

1. 37 2. RT

21
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

37C, (RT).
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:(/)

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22
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

( 1
3):

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) .

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23
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

. . : ( )

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24
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

9.

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25
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

, , . ,
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:

09/09/00 :1
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26
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

.
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27
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 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

FR.MIN: ( )
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28
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 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

C) :

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29
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 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

1.2 :
A) :
, .

: 1
. . . . .
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0.061
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( ).
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1: 2:
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7: 8:

, , 9 15, :

9: 10:
11: 12:
13: 14:
15:

30
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 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

D. ():

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31
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 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

, .
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32
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

READ ()

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1 (8) 50/5002 2
2 (8) 50/500
3 (8) 50/500
4 (9) 50/500
5 (9) 50/500
6 (9) 50/500
7 (10) 50/500
8 (10) 50/500
9 (10) 50/500
10 (6) 10/500
11 (6) 10/500
12 (3) 25/625

() .
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.
:

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33
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

N. ( )

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.

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34
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

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35
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

10.
.
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36
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

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.

37
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

.
.

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1
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3
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5

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38
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

, . , 5.
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4. 546 5. 578 6. 630
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:

1: 2: 0.000 3: 0.000 4: 0.000

5: -0.001 6: -0.001 7: -0.001 8: 0.000
9: 0.001 10. 0.000 11.-0.001 12. 0.000
13. 0.000 14. -0.001 15. 0.001

. . ( ):
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:

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39
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

( )

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15

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.

40
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

. . ( ):
.
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N.1 2 (1)
M: 88.00
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CV: 0.00

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41
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

11. 2 ( 2)
2 ( 2) ,
.
() 90 :

1.
2.
3.
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6. . .. .
7.
8. 8 ( )

9.
10.
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1 :

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.

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2 .

18/01/2005
18:52:08
?

0/ .
1/, :

42
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

( XX ) ( XX )
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.

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.

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.

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43
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

: ( )

: ( 0 - 15 )

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.

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44
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

17. . :

.
18. :

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.

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,
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Clima MC-15 20 .

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ID.

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.

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45
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

, ,
.

:
:

A: .
B: .
LL: .
FxL: , ,
( ).
F.R.MAX: ( ).
F.R.MIN: ( ).

14. CLIMA MC-15

. ( )

= . / (A1-A2) x (A1-A2)

A1: ..
A2: ..

(
) .

. ( ):

= x . /

. / = / x 2 ( 30 ).
. / = / x 1 ( 60 ).

. ( ):

= (A2-A1) x . / .

A2: .. ( )
A1: .. ( )

. ():

. . = [ (A2-A1) - (A2-A1) ] x [ . / (A2-A1) - (A2-A1) ]

A2: ,
A1: ,

15. CLIMA MC-15

, ,
( Diasys).
.

46
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

20-25C.
,
10 . 400 800
( 500 ).

:
.
. , :

.
.

.
,
.

:
,
:

, .

, , , .

. ,
1 15 .

, , , ,
.

, - (5 10 .)
.

, :

1. .
, (
).

2. , .
.
, . ,
:

- , ( )
( ) .
.

- ( ) .
.

- ,
.

15
5 . :

- , .
47
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

- , .

- -.

, :

1. .
, . ,
.

2. (..
).
. , ,
, .

3. .
( ) .

4. , ,
. .
, 10 .

:
, , ,
, .
, 1 ,
2 . 3 5 .

48
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

16.

1:

:
1.
2. 1.
3. 2.
4. 4.
5.
6. (.)
( 1) 7.
8.
1. . 9.
2. . 10.
3. 11. (. )
4. . . 12. - ( )
5. 13. - ( )
6. 14. ( )
7. . 15.
8. . 16. ()
9. . .. 17. ( )
10. .. 18.
11. 19.
12. . . . 20.
90. 2 21.
22.
2 23.
( 2) 24.
25. ( )
1. 26.
2. 27.
3. 28.
4. / 29. (. .)
5. 30. -
6. . .. . 31. -
7. 32.
8. 8 33.
9. 34.
10. 35.
11. 36. IGA
12. 37. IGG
13. 38. IGM
14. 39.
15. . 40.
16. 41.
17. .

18.
19. . .
20.

2:
49
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

0. 1. 2.
3. 4. 5.
6. 7. 8.
9. - 10. - 11. 3
12. 4 13. 14.
15. 2 16. 17.
18. 19. 20.
21. 22. 23.
24. 25. 26.
27. 28. 29.
30. 31. IGA 32. IGE
33. IGG 34. IGM 35.
36. 37. 38.
39. 40. 41.
42. 43. 44.
45. 46. 47.
48. 49. 50.
51. 52. 53.
54. 55. 56.
57. 58. 59.
60. 61. 62.
63.

50
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

3: Clima MC-15
1. (. 1):

. 1

2. 3 4 ,
(. 2):

. 2

3. 10 ,
(. 3):

. 3

51
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

4.
, (. 4):

. 4

5. (- ) ,
(. 5):

. 5

52
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

6. , ,
(. 6):

. 6

.
15 .

7. (. 7) (
):

. 7

,
( , ) . ,
( 6 2, 90
1) 1 (340 ), 7,
. , :
-> 4 -> 1 -> 90 -> -> 6 -> -> (1) -> -> (7)
-> ->

53
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

8. 4 6
(. 8). .

. 8

9. ,
. ,
.

10. , 9 2.(
) -> 4 -> 90 -> -> 9 -> .

11. 7 6
2. 900 (
450 ( 6 2).

54
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

4:

CLIMA MC-15 ( )
.
1 .

,
. 1.
1.

1.
2.

3.
(- )

.

, . 2.

2.
; ,
,
.
-7.
.203.329.004 .
: + 0,5%
02,5 .

, .
,
.

,

.

50267.0-92,
, ,
.

50444 :
(20 5) ;
(60 15) % (20 5) ;
(101,3 4,0) (760 30 . .).

55
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

:
- ,
;
- ;
- ( ).
,
, , ,
, ,
.

,
, .
. (
) 2 , ,
.
-2-2-000 25-1894.003,
(0.34/+0,00043).
,
.

.
( )
:
4 .
.
9, 0
. 2.
6 .
. .. . ( ).
, 340
. , .
2 2.
,
.
.
, ,
.
.
2 , 2
. . 10
Di (i = 110).
.
D :
10

D i
,
D i 1

10

Di 10 .

=((D-D0) / D0)100%,

56
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

Do 2 . D
.

, :

D D
10
2
i
1
S i 1
100%
D 9

3-6 340 ,
7-10 .
,
,
0,4 , 5%
, ,
1%.
0,4 ,
0,02
5%.

CLIMA MC-15,
, .
.
CLIMA MC-15,
, ,
.

57
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

5:

Cat. No. Description

FB00115905 Base device

FB00115161 Head printer
FB00999006 Connection cable
FB00115205 Device
FB00999256 Transmission belt
FB00115100 CPU
FB00999923 Screwdriver
FB00115254 Display
FB00000110 MC 15 label MC-15
FB00000100 Ral label RAL
FB00999305 Filter 340 nm 340
FB00999308 Filter 405 nm 405
FB00999309 Filter 500 nm 500
FB00999310 Filter 546 nm 546
FB00999311 Filter 580 nm 580
FB00700304 Filter 630 nm 630
FB00115404 Mix support bar
FB00115014 Cover
FB00999035 Fuse
FB00115302 Incubation group

FB00115040 Reading group guide
FB00115162 Printer interface
FB00999005 General switch
FB00115399 Lamp
FB00999920 Allen key
FB00999403 M27C4001 M27C4001
FB00115718 Agitator ribbon cable
FB00115160 Head printer ribbon cable

FB00115706 Reading group connection ribbon cable

FB00115708 Opto ribbon cable
FB00115720 Printer ribbon cable
FB00115721 Lamp male ribbon cable
Earth connection power supply ribbon
FB00115723 cable -
Earth connection optical group ribbon -
FB00115722 cable

FB00115709 Reading group motor ribbon cable
FB00115707 Multiple ribbon cable
FB00115712 NTC ribbon cable
FB00115716 NTC-incubator ribbon cable -
FB00115702 Flat ribbon cable
FB00115703 16-wires flat ribbon cable 16-
FB00700152 26-wires flat ribbon cable / keyboard 26-
FB00115704 34-wires flat ribbon cable 34-
FB00115713 Resistor ribbon cable
58
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

FB00115717 Resistor-incubator ribbon cable -

FB00115719 Printer R-S ribbon cable R-S
FB00115705 RS232 ribbon cable RS232
FB00115714 Signal ribbon cable m / m m/m
FB00115715 Signal ribbon cable m / air m/
FB00115710 Transformator ribbon cable
FB00115711 Ribbon cable fan / motor
FB00115016 Manual
FB00115018 Aplicattions
FB00115340 Fan micro switch
FB00115031 Mixer motor

FB00115502 Filters motor

FB00115501 Reading group reductor motor
FB00999303 NTC
FB00999705 Opto QVA
FB00123911 Plastic leg ( 8 )
FB00999420 RAM battery
FB00999441 RAM DS1644 DS1644
FB00123910 Fan protection
FB00115303 Heating resistor
FB00115350 Filters support ( including filters )
FB00115500 Complete power supply board
FB00115013 Interface board
FB00999712 Preamplifier board
FB00115006 Keyboard
FB00115005 Transformator
FB00115011 Fan 40 x 40 40 40
FB00121101 Fan 92 x 92 x 25 92 92 25
FB00200003 Buzzer

17.
:
(
). , ,
.

.
.

:
, ,
,
.

59
RA115000/V5/R3/1206/EA
 RAL Tcnica para el Laboratorio, S.A. Clima MC-15
RA 115000

18.
1. :
AL 1; AL 2; AL 3; AL 4; AL 5 Alarm
2. :
M ( Mean):
C.V ( Coefficient Deviation):
N ( Number):
S.D. ( Standart Deviation):
R ( Ratio):
3. :
H ( High):
.
L ( Low):
.
LL: .
FL: ,
, , .
FR.MAX: ( )
.
FR.MIN: ( ) .
4. :
IGA; IGG; IGM; IGE A, G, M, E

:

117452, , ,
, . 8, 9
.: 8-(495)-975-78-10, 8-(495)-975-78-11
: 8-(495)-975-78-12
e-mail: sale@diakon-diagnostics.ru
: www.diakon-diagnostics.ru

:
( 495): 967-72-63, 778-37-23
( 4967): 73-04-03; 73-06-93; 33-05-54
: 33-05-28

60
RA115000/V5/R3/1206/EA