Roche cobas h 232 ユーザーマニュアル

cobas h 232 POC

1.0

2006-10

2.0

2009-09

3.0

2011-09

SW 03

4.0

2014-05

OTS

0 6559832001 (02)

2014-05 ZHS

cobas h 232 POC

4.0

ROCHE CARDIAC COBAS COBAS H IQC Roche

cobas h

232

98/79/EC

UL UL 61010A-1:02

CAN/CSA-C22.2 61010-1-04

1 IEC 60825-1

S/N 200000

IVD

5

1

9

cobas h

232 .......................................................................................................................... 9

............................................................................................................................................. 10

............................................................................................................................... 10

1.1 ............................................................................................................... 11

......................................................................................................................

12

........................................................................................................................................ 13

............................................................................................................................................. 13

........................................................................................................................................ 14

............................................................................................................................................. 14

.................................................................................................................................................. 14

.................................................................................................. 15

................................................................................................................................... 15

2 cobas h 232 POC

16

2.1

............................................................................................................................. 16

................................................................................................................................................. 16

....................................................................................................................................................... 19

............................................................................................................................................. 20

3

21

4

23

....................................................................................................................................................... 24

............................................................................................................................... 25

.......................................................................................................................... 27

5

29

............................................................................................................................................. 30

5.1

..................................................................................................................................................... 35

.................................................................................................................................................. 35

....................................................................................................................................................... 37

............................................................................................................................................. 39

............................................................................................................................................. 41

....................................................................................................... 43

....................................................................................................................................................... 45

............................................................................................................................................. 48

5.2

........................................................................................................................................... 50

..................................................................................................................................................... 50

.................................................................................................................................................. 51

.................................................................................................................................................. 52

............................................................................................................................................. 54

............................................................................................................................................. 57

................................................................................................................................... 59

5.3

ID

............................................................................................................................................... 61

ID............................................................................................................................................ 62

ID............................................................................................................................................ 68

ID................................................................................................................................................. 71

6

5.4 ..................................................................................................................................................... 73

........................................................................................................................................ 74

(QC) ................................................................................................................................. 77

(QC) ................................................................................................................................. 79

(QC) ........................................................................................................................ 80

QC ...................................................................................................................................... 81

T ....................................................................................................... 82

.................................................................................................................................... 84

............................................................................................................................................. 85

.................................................................................................................................... 86

5.5

............................................................................................................................................ 88

6

91

............................................................................................................................................. 92

6.1

..................................................................................................................................................... 93

............................................................................................................................................. 93

.................................................................................................................................. 94

.......................................................................................................................... 95

........................................................................................................................................ 96

....................................................................................................................................................... 97

6.2

................................................................................................................................................... 100

.......................................................................................................................................... 104

...................................................................................... 109

........................................................................................................................................... 112

7

113

7.1

................................................................................................................................ 113

7.2

.......................................................................................................................................... 115

(QC) ................................................................................................................................ 115

(IQC)...................................................................................................................... 121

8

125

.................................................................................................................................. 125

........................................................................................................................................... 127

........................................................................................................................................... 128

(QC) ...................................................................................................................... 129

(IQC) ........................................................................................................... 130

........................................................................................................................................... 131

9

132

........................................................................................................................................... 132

................................................................................................................... 133

...................................................................................................................................... 134

........................................................................................................................................... 135

.................................................................................................................................. 136

.............................................................................................................. 136

10

139

/ .......................................................................................................... 140

/ ............................................................................................ 140

..................................................................................................... 141

............................................................................................................................. 142

..................................................................................................... 143

7

11

145

................................................................................................ 146

12

147

12.1

........................................................................................................................... 147

........................................................................................................................................... 147

........................................................................................................................................... 148

............................................................................................................................. 148

12.2

................................................................................................................................................... 148

........................................................................................................................................... 148

........................................................................................................................................... 150

........................................................................................................................... 150

..................................................................................................................................................... 150

........................................................................................................................................... 150

13

150

14

151

14.1

..................................................................................................................................... 151

14.2

................................................................................................................................................... 152

15

159

(OTS)........................................................................................................... 159

OTS ................................................................................................................................ 160

16

163

8

9

1

cobas h 232

cobas h

232

cobas h

232

cobas h

232

cobas h

232

cobas h

232 (DMS)

cobas h

232 POCT1A

LIS HIS

DMS

cobas h

232 5“ ”

“ ”

cobas h

232

12

cobas h

232

cobas h

232

cobas IT

1000 PC/DMS

PC/DMS

10

cobas h

232

LED

■

cobas h

232

■

CD-ROM

■

USB

14

11

1.1

cobas h

232

12

cobas h

232

cobas h

232

cobas h

232

cobas h

232

■

/

■

/

■

/

■

13

cobas h

232

+ /

cobas h

232

“ ”

139

14

1 EN 60825-1:2007

■

15

cobas h

232

■

– A Z

– a z

– 0 9

– ! $ # %

■

uhxwze11

■

UHXW13SF

■

uxxxxx7F

■

x12useridF

ID

“userid” ID

cobas h

232 “ ” 147

cobas h 232 POC

16

2 cobas h 232 POC

2.1

A

B

D

E

C

G

CLASS I LASER PRODUCT

Complies with 21 CFR 1040.10

and 1040.11 except for deviations pursuant to Laser

Notice No. 50, dated July 26, 2001

H

F

I

cobas h 232 POC

17

A

B /

C

D

E

ID

200 000

F

G

H

4

I

cobas h 232 POC

18

J

K

L (IR)

M

N

/

O

M

J

O

L

N

K

cobas h 232 POC

19

P

Q

R

S

R

P

Q

S

cobas h 232 POC

20

T

/

U

V (IR)

W

cobas h

232

X /RJ45 USB

(DMS)

Y

Z

T

U

V

Y

Z

W

X

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