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Konelab
www.thermo.com/konelab
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KONELAB
: 6.0
: E
: 5.4.2004
: D01626
.
Thermo Electron Oy Ratastie 2, P.O.Box 100
FIN-01621VANTAA
: +358 9 329 100Fax: +358 9 32910500
www.thermo.com/konelab
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D01626 25.11.2003 I
,
1. 1
2. 22.1 22.2 32.3 4
2.3.1 Konelab 60 Konelab 30 42.3.2 Konelab 20XT Konelab 20 5
3. 8
4. 10
5. 1313
5.1 145.2 145.3 ISE Prime Start up 155.4 165.5 /QC 17
5.5.1 17
5.5.2 QC 185.6 , 205.7 205.8 QC 21
5.8.1 215.8.2 23
5.9 255.9.1 255.9.2
275.9.2.1 275.9.2.2 30
5.9.2.3 345.9.3 37
5.9.4 STAT 385.9.4.1 STAT
385.9.4.2 STAT
385.9.4.3 STAT 395.9.4.4
STAT 395.10 40
5.10.1 405.10.2 / 42
5.11 445.11.1 LIMS 46
5.12 Stand by 475.13 48
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D01626 25.11.2003 II
5.14 505.14.1 505.14.2 52
6. 536.1 53
6.2 , 546.2.1
54
6.2.2 546.2.3 546.2.4
546.2.5 556.2.6 556.2.7 56
Copyright 2003 Thermo Electron Oy. ..
Konelab Thermo Electron Oy.
Thermo Electron Oy .
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,
CE Konelab IVD ( in vitro) 98/79/EC.
FCC
, 15 FCC. . , , , . , . , , :
- .- .- .- .
in vitro
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6/66D01626 08.01.04 I
:, . . .
:.
.
13
4
5
2
6
1 2
7
1
2
: Kusti .
Kusti.
3
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D01626 25.11.2003 II
: . .
.
: . .
4
5
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D01626 25.11.2003 III
: , Konelab 60 KUSTI, .
.1) , ON (I), , on. 5.14.2.
2) stand by , PC . , , , off. , .- , .
PC stand by .
6
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D01626 08.01.04 IV
: .
PC UPS () XP PC .
7
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D01626 25.11.2003 1
1. TOY
Konelab invitro , , ,.
Konelab 60 & Konelab 30
. E. B. F.
C. G.
D. , KUSTI
A
B
CD
E
F
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Konelab
D01626 08.01.04 2
Konelab 20XT & Konelab 20
A. /STATB. C. D. .
2.
2.1
:
enter tab .
, shifttab.
:
.
/, .
BC
D
E
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Konelab
D01626 25.11.2003 3
:
:
/:
.
! STAT.
* , .. * .
F9 /.
F10 .
F11 .
F12 .
2.2
- Start()
START() . .
- Stop()
STOP() . START ().
.
.
, ..
.
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Konelab
D01626 25.11.2003 4
2.3
2.3.1 Konelab 60 Konelab 30
. :
(LA) , .
LED , .
B. STAT: (LB)
STAT. STAT., STAT.
C. :
(LC) , .
LED , .
C
LC
.
./.
A
B
LA
LB
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Konelab
D01626 25.11.2003 5
D. :
(LD) . .
, .
2.3.2 Konelab 20XT Konelab 20
E. / Stat:
Konelab 20XT 20, F2 /.
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Konelab
D01626 25.11.2003 6
(LE) . /STAT. , . .
STAT
F5, Insert stat sample (stat) /.
(LE) . /STAT. , STAT. .
E
LE
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Konelab
D01626 25.11.2003 7
F. :
(LF) , .
LED ,
.
G. :
Konelab 20XT
20 . F2 Reagent disk ().
F
LF
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Konelab
D01626 25.11.2003 8
(LG) . . , (G) . .
3.
: (..
, ..) .. Cuvettes().
LG
G
A BE
F
G
H
I
L
M
J
K
N
Start up.
..
.
C D
.. .
A
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Konelab
D01626 25.11.2003 10
:
(C, D, F, G, H, I K).(L, M N).
- -
(C, D, F, G, H, I K)
, .. F10 TEST RESULTS ().(L, M N), .. F9 F8/F6 SAMPLE SEGMENT ().
4.
- Batch entry()
.
- Configuration()
Configuration (),.. . .. :, /, : ISE .
- LIMS configuration(LIMS)
.
- Management () QC .
- User management()
.
- Restrictions () .
- Messages () .
- Profile definition()
.
- Reagent definition()
.
- Reagent disk ()
.
.
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Konelab
D01626 25.11.2003 11
- Reference class definition()
.
- Reports () .
- LIMS connection(LIMS)
online.
- Sample disk ()
.
- Sample/ Patient entry(/)
/. () .
/.
- Sample list ()
.
- Sample/ Patient results(/)
/. ,, .
- Sample segment()
14 .
- Pending requests()
.- Sender definition()
, /.
- Calibrator & Controldefinition (
)
.
- Calibration parameters()
.
- Calibration results
()
. ..
- Calibration/ QC selection(QC /)
.
QC ..
- Quality control results()
.
- Results by controls()
.
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Konelab
D01626 25.11.2003 12
- Quality controlparameters ()
.
- Test definition ()
. .
- Test flow ()
, , ..
- Electrodes () .
- Test results()
. , ,.
.
- External results()
.
- Result archive ()
.
- Calibration archive()
,.
- Reagent lot archive
()
.
- Statistics () , .
- Report formats()
, .
- Instrument actions()
, ..ISE prime . .
- .
- Maintenance()
. .
- Accuracy results()
, . .
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Konelab
D01626 25.11.2003 13
- Accuracy factors()
. . , .
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KONELAB
D01626 08.01.04 13
5.
.
START
() .
QC
.
Stand by ():
. .
.
, .
.
QC/.
START.
,
.
,
. QC .
QC.
START
Main ()
ISE Prime
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KONELAB
D01626 25.11.2003 14
5.1
:
.
User
manager ().
5.2
.
.
.
.
ISE 1 .
.
.
:.
.
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KONELAB
D01626 25.11.2003 15
5.3 ISE PRIMESTART UP ()
Konelab 20XT 20 ISE primeSTAT. Konelab 60 30 ISE prime ,0,5 2 ml .
START UP () :
.
STAND BY().
.
START UP () :
.
.
ISE 1 ISE.
ISE ISE Prime.
.
Start up ().
'Start upneeded'() ..
.
. .
.
F1Start up
Start up. .
START UP, .
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KONELAB
D01626 25.11.2003 16
5.4
. Konelab 60 30,F8/F1 . F1 .
.Reagent position(
) .
.. , . Konelab 20XT/20, . . Konelab 60 30 . Konelab 20XT 20 , F2 .
.
. F2 Konelab 20XT/20 .
. .
,QC . F4. .
,
.
, CapsLock .
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KONELAB
D01626 25.11.2003 17
F8/F3 . , ... F8/F3 .
5.5 /QC ()
5.5.1
QC ,
, ..S1...S19
,
F1.
F4
- F2 K20/20XT
- .. K30/60
F6
./.
, .
! ,
Cal/QCselection (/) . 'Disk pos' () , .
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KONELAB
D01626 25.11.2003 18
QC () ()START ().
5.5.2 QC ()
QC ()START ().
QC ,
, ..C1...C19.
-, -.
F2. QC
F4
- F2 K20/20XT
-
. . K30/60
F6
./.
, .
!
, Cal/QC selection(/) .'Disk pos' () ,.
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KONELAB
D01626 25.11.2003 19
F5 QC , .
/ ISEprime/ Konelab 20XT Konelab 20
F4, Add prime/wash (prime/)ISE prime . , STAT .
/Konelab 60 Konelab 30
F4 / . . , .
/.
- -
F3, . /. .
. .
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KONELAB
D01626 25.11.2003 20
5.6 ,
Konelab 20XT 20 STAT.
Konelab 60 30 STAT. , ./. , 0,5 2 ml , ,.
/. . ,
.
Konelab 60 30 , .
Konelab 20XT 20 ,.
5.7
START () . Main () .
. ./.
.
Konelab 60 30,
./. ..
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KONELAB
D01626 25.11.2003 21
5.8 QC()
5.8.1
F2 . , F6.
F3 . .F5.
. .
. ../QC
F7. .
.
F7..
. .
F8/F7..
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KONELAB
D01626 25.11.2003 22
F5, Delete calibration (),. , .
:
: .. .
- F1 . . F8/F1 .
- F8/F3 .
- F8/F2 .. .
:
CALIBRATIONPARAMETERS () Bias corr. repeat time() . 4.4.1.
-
F8/F6
.
- F8/F7 . .
.. , .
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KONELAB
D01626 25.11.2003 23
5.8.2
F1 QC (Display cumulative/ Display results /).
QC:
QC, . SD () . F6, .
QC , . SD () . F6, .
QC. Mean QC SDQC.
. QC
. ./QC
F6. QC
.
F8/F1. QC
QC()QCCleardaily files (. ).
QCCleardaily files Management().
A
B
C
A B
D
C
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KONELAB
D01626 25.11.2003 24
SD . Z ,. :Z = (QC
)/ .
F2 , . Result statistics () .
F3 , . Result statistics ()
.
F5 . .
F7 .
D
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KONELAB
D01626 25.11.2003 25
5.9
5.9.1
/.
Konelab 60 Konelab 30
.
, .
. .
(F9) . C .
Konelab 20XT Konelab 20
F2, Insert segment () /..
. .
10 mm ..
.
.
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KONELAB
D01626 25.11.2003 26
, . . C.
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KONELAB
D01626 25.11.2003 27
5.9.2
5.9.2.1
.- -
Segment() ..(. 16 )
.F8/F2 .
A
C
C
D
E
F
B
. .
P1 ISEP2 Lipids
, , . .
A
B
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KONELAB
D01626 25.11.2003 28
, . ./. Konelab 60 30
.(QC) QC/.
:.
- -
Next request() .
. P .
Konelab ASTM . .
. .
STAT. F7, STAT. !.
,
() S. , U-Alb U/CSF Prot, U/CSF Prot S. , R (). .
.
(1-14) .
, ..
Position() .
.
.
. /.
F1 .
C
D
.
E
F
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KONELAB
D01626 25.11.2003 29
./.
- -
F3, . /. .
Remove () 0
. . /.
F3 .
F3 . F3 .
F8/F3 .
F8/F8/F5 , .. .
A
B
C
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KONELAB
D01626 25.11.2003 30
F8/F8/F1 .
Sample entry(),
.
. 1 120 0.5.
D .
5.9.2.2
.
- -Segment() .
.
. .
A
D
C
D
F
G
B
E
A
A
B
C
, ,
Configuration().
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KONELAB
D01626 25.11.2003 31
(. 16
) .F8/F2 .
, .
./. Konelab 60 30 . (QC) QC/.
. .F8/F8/F2 .
:
.
- -
Next request() .. P .
Konelab ASTM
. .
. . STAT. F7, STAT. !.
, () S. , U-Alb
U/CSF Prot, U/CSF Prot S. , R (). .
:
(1-14) .
, ..
Position() .
G
B
C
D
E
F
.
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KONELAB
D01626 25.11.2003 32
.
.
. /.
F8/F1 ..
F1 .
. /.
- -
F3, . /. .
Remove () 0
. . /.
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KONELAB
D01626 25.11.2003 33
F3 .
F3 . F3 .
F8/F3 .
F8/F8/F5 , .. .
F8/F8/F1
.Patient entry(), .
. 1 120 0.5.
D .
A
B
C
A
B
C
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KONELAB
D01626 08.01.04 34
5.9.2.3
F1. . , .. .
(. 9 )
.F8/F2 .
, .
- -
Segment()
.
.
.
./
F8/F4
.
F8/F8/F4
Batch entry
E
A
E
BC
H
D
F
I
F8/F4
.
.
F7.
. .
F7.
G
.
A
B
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KONELAB
D01626 08.01.04 35
. Position
() .
.
. .., .. 2 9 2.9 .
:
.
- -
F5
Next request() . . P
.Konelab ASTM . .
.
. , 19 2 , 38 .
.
F2 .F3 .
. /.
. /.
- -
F3, . /. .
Segment() 0. . /.
C
D
E
F
G
.
H
I
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KONELAB
D01626 25.11.2003 36
F6 .
F6 . F6 .
(. 13 )
.F8/F2 .
Sample numbers(
) . .1000 .
.
., .. Srg11 12 Srg11012.
:
.
- -F5 Next request()
. . P .
Konelab ASTM
A
B
C
D
F
G
E
H
D
A
B
C
D
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KONELAB
D01626 25.11.2003 37
. .
.
. , 26 2 , 52 .
.
F2. F3 .
F6 .
F6 . F6 .
5.9.3
Konelab
KUSTI ,. KUSTI Konelab.
KUSTI KUSTI
KUSTI
.
, .
E
F
G
H
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KONELAB
D01626 08.01.04 38
. .
, Sample/Patient entry (/).
5.9.4 STAT
5.9.4.1
STAT
Konelab 60 Konelab 30
STAT STAT . . STAT. .
. .
(F9), . C 5.9.2.1D 5.9.2.2.
Konelab 20XT Konelab 20
(F9), F5,Insert stat sample(stat). . STAT.
.
, STAT . .
Sample/Patient entry (/) . C 5.9.2.1D 5.9.2.2.
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KONELAB
D01626 25.11.2003 39
5.9.4.2 STAT
(F9), ///, . 5.9.2.1 B, C E 5.9.2.2B, D F.
F5, Insert stat sample(stat).
Konelab 60 30 STAT.. STAT. . Konelab20XT 20 STAT .
STAT .
5.9.4.3 STAT
(F9), STAT.
F6, Remove STAT sample (STAT).
STAT Konelab 60 30.. STAT. . Konelab 20XT 20 STAT ..
5.9.4.4 STAT
STAT. 5.9.1. 5.9.2.
SAMPLE/ PATIENT/ BATCH ENTRY(//)F7, STAT, STAT.!Stat ON!
, F7 (
STAT off) . STAT .
STATSTAT .
STAT. STAT .
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KONELAB
D01626 08.01.04 40
5.10
5.10.1
: . . .
F8/F4 .
- F2 .F3 .
- F5 . , CV () .
- F8/F3 .
- F8/F6 .
. .
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KONELAB
D01626 08.01.04 41
. 1120 0.5... 9 1+9 1:10.
- F8/F2 . .
- F8/F8/F1, CV () . CV .
QC
QC - / Stat - QC 'Batch incomplete' ()- ctrl-stop - .. QC
.
QCQC. QC, Calibr./QC selection (./QC).
F8/F8/F3 . start () .
, No () Test in use () Test definition().
F1..F8/F1.
.
.
.
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KONELAB
D01626 25.11.2003 42
5.10.2 /
: . . .
- F2 .F3 .
- F5 .
- F8/F3 .
- F8/F4 . . 1 120
0.5. .. 9 1+91:10.
- F8/F2 ..
,, Configuration().
. .
.
F5.
. .
.
F5.
.
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KONELAB
D01626 25.11.2003 43
F1 ..F8/F1 .
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KONELAB
D01626 25.11.2003 44
5.11
:- ,
- - ./:- . ,- (),- (, ),- ().:- ,-
- .:- - .
A
C
A
B
LIMS
F4
D
.
F4
B
C
D
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KONELAB
D01626 25.11.2003 45
F2 //.
F3 .F4, Daily report () . , . .
Excel
F8/F4 excel.excel C:\Konelab\Results.
-
.
- (, ). .
(. 30 ).
. .
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KONELAB
D01626 25.11.2003 46
5.11.1 LIMS
F1 .
: .
.
F3, Send results ().
: .
.
F2, .
F5 LIMS .
LIMS
A
B
C
D
F
E
LIMS ASTM, .
F5LIMS
A
B
C
D
E
F
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KONELAB
D01626 25.11.2003 47
5.12
.
ISE Prime ./Konelab 6030.
KUSTI KUSTI.
STAT Konelab 20XT 20.
STAND BY :
, ISE, KUSTI .
.
.
.
F2Stand by
Stand by
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KONELAB
D01626 08.01.04 48
5.13
F7 . //. QC ,, , . .
F2 . .
F5 . .
F6 CD.. CD Configuration ().
F8/F6
. , , , , , .. F7. . .
.
.
F8/F3
F7
8000
(
)
10000.
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KONELAB
D01626 08.01.04 49
F1.F4 About () Konelab , PC Konelab 60 30.F8/F3 Konelab .
1. .
. =
.
KONELAB
QC
QC QC QC
. QC,
. QC
.
.
.
()
/
/ .
/ /
()
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KONELAB
D01626 01/03/2004 50
5.14
5.14.1
Konelab Management() F8/F3.
(Start: Shut down (:) ). .
Konelab OFF .
!
PC
.
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KONELAB
D01626 25.11.2003 51
Konelab 60 KUSTI
Konelab 60 KUSTI ,
, stand by .
stand by, PC .
, .
PC stand by
.
: .
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KONELAB
D01626 29/03/2004 52
5.14.2
.
(domain Konelab Konelab). Konelab .
Konelab ON Konelab.
Konelab 60 KUSTI
Konelab 60 KUSTI, , ON (I). , .
Konelab20XT/20,
Konelab 20XT/20,
PC!
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KONELAB
D01626 08.01.04 53
6.
6.1
Maintenance () . .
.
F1.. .
F2. F3 .
F8/F7
F8/F7
A
B
,
A
B
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KONELAB
D01626 08.01.04 54
F4 . . *
, .. .
6.2 , &
6.2.1
.STAND BY. .
F8/F4 Clean needles () Instrument actions (). , . , .
(4,5%) 50-60% . .
6.2.2
. 50-60%.
6.2.3 . . .
6.2.4
(50-60%) /.
, , (50-60%) . T(Trihydrate) 99% .
Clinical
Chemistry &
Automation
Systems
business
Thermo
6.2
.
!
50-
60%
.
.
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D01626 29/03/2004 55
6.2.5
. Start up () . , .
Konelab Management() F8/F3.
(Start: Shut down (:) ). .
. (domain Konelab
Konelab). Konelab .
6.2.6
. FMI .
.
100 ml (1:5) (=4,5%, 980929) .Konelab 60, 150 ml.
Instrument Actions F6 (), Perform water wash ().
(K60 700 - 850 ml K30350 450 ml K20XT/ 20 300 350 ml) , Perform water wash 5 - 6 . , .
Perform water wash 2 3 .
FMI
.
.
.
,
brij,
.
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6.2.7
.
.
Stand by .
T . .
(4,5% ) 50-60 %.