STA Compact Max Reference Manual [PDF]

Zitiervorschau

0931946

Reference Manual

0931946

Reference Manual Name and address of the retailer:

Information contained in this document, in particular data, pictures, information, trademarks and logos are protected by copyrights and other intellectual property rights. © 2012, Diagnostica Stago, all rights reserved - 10/2012. Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would be considered a violation of Diagnostica Stago's copyrights and other intellectual property rights. Visual representations (diagrams, pictures, icons, pictograms, screenshots, spare parts, ...) are not contractual.

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Table of contents

1

Symbols and warnings . . . . . . . . . . . . . . . . . . . . . . .

1

1.1

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

1.2

General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

1.3

Warnings concerning the handling of biological products . . .

4

1.4

Warnings concerning methodologies . . . . . . . . . . . . . . . . . . .

4

1.5

Warnings concerning the use of access codes . . . . . . . . . . .

6

1.6

Warning concerning the analyzer. . . . . . . . . . . . . . . . . . . . . .

6

1.7

Warnings concerning the cap piercing options . . . . . . . . . . .

8

1.8

Warnings concerning the analyzer disposal . . . . . . . . . . . . .

8

2

System presentation . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.1

Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2.1 Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2.2 Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

2.3

Chronometry Measurement Principle. . . . . . . . . . . . . . . . . . .

2

2.4

Photometry Measurement Principle . . . . . . . . . . . . . . . . . . . .

3

2.5

STA Compact Max® description . . . . . . . . . . . . . . . . . . . . . .

6

2.5.1 STA Compact Max®, overall view . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

2.5.2 STA Compact

Max®,

front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

2.5.3 STA Compact

Max®,

rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

2.5.4 STA Compact Max®, left side view . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

2.5.5 STA Compact Max®, right side view . . . . . . . . . . . . . . . . . . . . . . . . . .

12

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2.6

General Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

2.6.1

Sample Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

2.6.2 Product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

2.6.3 Measurement plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

Technical specifications STA Compact Max® . . . . . . . . . . . .

18

2.7.1 Technical specifications - Part 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

2.7.2 Technical specifications - Part 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

2.7.3 Technical specifications - Part 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

2.7.4 Technical specifications - Part 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

2.7

3

Analyzer preparation . . . . . . . . . . . . . . . . . . . . . . . . . 1

3.1

Turning the analyzer on. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2

Loading the disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2.1 Loading the cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2.2 Loading the washing solution bottle . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

3.3

Loading products and samples . . . . . . . . . . . . . . . . . . . . . . .

10

3.3.1 General information on loading operations . . . . . . . . . . . . . . . . . . . . .

10

3.3.2 Identifying and loading products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

3.3.3 Identifying and loading diluents (sample drawer) . . . . . . . . . . . . . . . . .

17

3.3.4 General information on sample loading . . . . . . . . . . . . . . . . . . . . . . . .

20

3.3.5 Identifying and loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

3.3.6 Modifying loaded products or samples . . . . . . . . . . . . . . . . . . . . . . . . .

28

3.3.7 Unloading samples or products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

4

Routine use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4.1

Analysis status and product status . . . . . . . . . . . . . . . . . . . .

1

4.1.1 Analysis status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

4.1.2 Product status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

4.2

2

Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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4.2.1 General information about calibrations . . . . . . . . . . . . . . . . . . . . . . . .

2

4.2.2 Loading calibrators and calibration controls . . . . . . . . . . . . . . . . . . . . .

4

4.2.3 Running and validating calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

4.2.4 Procedures to observe in case the calibration is not automatically confirmed 11 4.2.5 Other possible interventions on confirmed calibrations . . . . . . . . . . . .

17

4.3

22

Quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.3.1 General information about quality controls . . . . . . . . . . . . . . . . . . . . .

22

4.3.2 Running and validating quality controls . . . . . . . . . . . . . . . . . . . . . . . .

24

4.3.3 Procedures to observe for out of range Quality Controls . . . . . . . . . . .

28

4.3.4 Other available operations on Quality Controls . . . . . . . . . . . . . . . . . .

30

4.4

Running analyses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

4.5

Switching the analyzer off . . . . . . . . . . . . . . . . . . . . . . . . . . .

34

5

Methodology management . . . . . . . . . . . . . . . . . . . .

1

5.1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

5.2

Creating a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

5.2.1 Creating a main methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

5.2.2 Creating a dependent methodology . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

5.2.3 Creating a calculated methodology . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

5.3

11

Modifying a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.3.1 Modifying a methodology parameter . . . . . . . . . . . . . . . . . . . . . . . . . .

11

5.3.2 Saving the modifications made to a methodology . . . . . . . . . . . . . . . .

12

5.4

Installing and updating STAGO methodologies . . . . . . . . . .

14

5.5

Modifying the display order of the methodology list . . . . . . . .

14

5.6

Deleting a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

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5.7

Page 1/3 of a methodology parameters: section Methodology 16

5.7.1 Identification section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

5.7.2 Sample section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

5.7.3 Diluent section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

5.7.4 Reagent section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

5.7.5 Definition of washing options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

5.7.6 Analysis section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

5.7.7 Section Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

5.7.8 Section Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

5.7.9 Section Redilution criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

5.8

Page 2/3 of a methodology parameters: section Calibration.

34

5.8.1 Pages 2/3 depending on the calibration mode . . . . . . . . . . . . . . . . . . .

35

5.8.2 Defining the calibration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39

5.8.3 Defining the offset correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40

5.8.4 Defining calibration controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

5.8.5 Defining scales (graphic or bar codes mode) . . . . . . . . . . . . . . . . . . . .

42

5.8.6 Defining calibrators (graphic mode) . . . . . . . . . . . . . . . . . . . . . . . . . . .

42

5.8.7 Defining the determination of calibrators (graphic mode) . . . . . . . . . . .

44

5.8.8 Defining display points (bar codes mode) . . . . . . . . . . . . . . . . . . . . . .

44

5.9 Page 3/3 of a methodology parameters: section Quality Controls and Printout/transmission 44 5.9.1 Section Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

5.9.2 Section Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

5.9.3 Section Usual values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

48

5.9.4 Section Printout Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

48

6

Patient File Management . . . . . . . . . . . . . . . . . . . . . 1

6.1

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

6.2

Patient Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

6.2.1

Select files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

6.2.2 Print files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

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6.2.3 Sending files to the host computer . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

6.2.4 Delete files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

6.3

8

Patient report form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.3.1 File information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

6.3.2 List of analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

6.3.3 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

6.3.4 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

6.3.5 Validation range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

6.4

16

Rerun or delete analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.4.1 Rerun analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

6.4.2 Delete analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

6.5

Block or resume methodologies. . . . . . . . . . . . . . . . . . . . . . .

18

7

System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

7.1

System status screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

7.1.1 Set the date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

7.1.2 Control the level detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

7.1.3 System status: temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

7.1.4 System status: timers, availability and general information . . . . . . . . .

7

7.2

9

Setup customised printout . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.2.1 Page 1 of the customised printout setup . . . . . . . . . . . . . . . . . . . . . . .

10

7.2.2 Page 2 of the customised printout setup . . . . . . . . . . . . . . . . . . . . . . .

12

7.2.3 Example of a customised printout . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

7.3

15

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.3.1 Change and save settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

7.3.2 Page 1 of the Settings menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

7.3.3 Configure the files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

7.3.4 Define the access codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

7.3.5 Define the arbitrary units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

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7.3.6 Page 2 of the Settings menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

7.3.7 Define the communication settings . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

7.3.8 Configure the barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

7.3.9 Define the cleaner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

7.3.10 Configure the audible alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

7.3.11 Configure the display of the date and time . . . . . . . . . . . . . . . . . . . . . .

22

8

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

8.1

Preventive maintenance schedule . . . . . . . . . . . . . . . . . . . .

1

8.2

Accessing the User Maintenance menu . . . . . . . . . . . . . . . .

2

8.3

Routine maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

8.3.1 Cleaning the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

8.3.2 Dry the product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

8.3.3 Checking the Peltier reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

8.3.4 Cleaning the sample and product drawers . . . . . . . . . . . . . . . . . . . . . .

5

8.3.5 Cleaning the measurement plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

8.3.6 Cleaning the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

8.4

11

Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8.4.1 Daily preventive maintenance: cleaning the piercing needle

.......

11

8.4.2 Weekly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

8.4.3 Monthly preventive maintenance: Replacement of the syringe Teflon tip and oring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 8.4.4 Quarterly preventive maintenance: air filters replacement . . . . . . . . . .

26

8.4.5 Every 100 000 piercings: replacement of the piercing needle . . . . . . .

27

8.5

Curative maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

8.5.1 Decontaminating a drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

8.5.2 Passing the stylet inside a clogged needle . . . . . . . . . . . . . . . . . . . . .

42

8.5.3 Replacing a sampling needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43

8.5.4 Replacement of the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

51

8.5.5 Replacing and testing the lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

54

8.5.6 Replacing main fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

59

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8.5.7 Replacing secondary fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

60

8.5.8 Eliminating air bubbles with needle purges . . . . . . . . . . . . . . . . . . . . .

61

8.5.9 Replacing the syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

62

8.5.10 Replacing the clamping electrovalve tubing . . . . . . . . . . . . . . . . . . . . .

65

8.6

67

Options of the user Maintenance menu . . . . . . . . . . . . . . . . .

8.6.1 Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

67

8.6.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

68

8.6.3 Save . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

69

8.6.4 Error history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

72

8.6.5 Photometry graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

74

8.6.6 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

78

8.6.7 Testing the barcodereader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

79

8.6.8 Host computer: testing connection . . . . . . . . . . . . . . . . . . . . . . . . . . . .

81

8.6.9 Data updating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

82

8.6.10 Utilities (saving patient data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

82

8.7

Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . .

84

8.8

Preparing the decontamination solution and diluted ethanol .

84

8.8.1 Preparation of the decontamination solution . . . . . . . . . . . . . . . . . . . .

84

8.8.2 Preparation of diluted ethanol (about 22%) . . . . . . . . . . . . . . . . . . . . .

85

9

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

9.1

Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

9.1.1 Blocking error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

9.1.2 Error messages with an error number . . . . . . . . . . . . . . . . . . . . . . . . .

2

9.2

Problem with the lamp: "Colorimetry lamp level is too low" . .

8

9.3

Problems with the cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . .

8

9.3.1 Problems with the cuvettes: "Loading station - shuttle missing" . . . . .

9

9.3.2 Problems with the cuvettes: another example . . . . . . . . . . . . . . . . . . .

10

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9.4

Problems with the results . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

9.4.1 List of points to be checked . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

9.4.2 Typical problems with the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

9.5

13

Problems related to the execution of the analyses . . . . . . . .

9.6 Problems related to positive identification (automatic detection of the position) 14 9.6.1 Problems related to positive identification when loading . . . . . . . . . . .

14

9.6.2 Problems related to positive identification when unloading . . . . . . . . .

15

9.7

Power-on problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

9.8

Problems related to the screen . . . . . . . . . . . . . . . . . . . . . . .

16

9.9

Problems reading the tube labels . . . . . . . . . . . . . . . . . . . . .

16

9.10 Inversion problems when loading the STA® Cleaner . . . . . .

17

9.10.1 Inversion without aspiration of the used liquid . . . . . . . . . . . . . . . . . . .

17

9.10.2 Inversion with aspiration of used liquid . . . . . . . . . . . . . . . . . . . . . . . . .

18

A

Icons, pictograms, status and alarms . . . . . . . . . . . . 1

A.1

Description of icons and pictograms . . . . . . . . . . . . . . . . . . .

1

A.2

Description of color codes and alarms . . . . . . . . . . . . . . . . .

5

B

Description of the software screens . . . . . . . . . . . . . 1

B.1

Description of the Test panel . . . . . . . . . . . . . . . . . . . . . . . .

2

B.2

Screen Loading products . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

B.3

Screen Loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

B.4

Screen Modifying methodology profiles . . . . . . . . . . . . . . . .

7

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B.5

Screen Analysis status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

B.6

Screen Product status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

B.7

Screen Patient analyses - Patient files . . . . . . . . . . . . . . . . .

12

B.8

Description of the Calibrations screen . . . . . . . . . . . . . . . . .

12

B.8.1 Screen Calibration - Methodologies list . . . . . . . . . . . . . . . . . . . . . . .

13

B.8.2 Pre-calibrated mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . .

14

B.8.3 Raw mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

B.8.4 Ratio mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

B.8.5 Graphic mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

B.9

21

Description of the Quality controls screens . . . . . . . . . . . . .

B.9.1 Description of screen Quality controls - Methodologies list . . . . . . . . .

21

B.9.2 Description of a result screen (graphic format) . . . . . . . . . . . . . . . . . .

22

B.9.3 Description of a result screen (table format) . . . . . . . . . . . . . . . . . . . .

25

B.10 Description of the Methodologies screens . . . . . . . . . . . . . .

27

B.10.1 Screen Methodologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

B.10.2 Methodology section (page 1/3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

B.10.3 Calibration section (page 2/3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

B.10.4 Printout/Transmission section of results and quality control (page 3/3)

34

B.11 Description of the System screens . . . . . . . . . . . . . . . . . . . .

35

B.11.1 Screen System status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

B.11.2 Settings 1 screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

B.11.3 Settings 2 screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38

B.12 Description of the Maintenance screens. . . . . . . . . . . . . . . .

39

B.12.1 Main screen of the User maintenance menu . . . . . . . . . . . . . . . . . . .

39

B.12.2 Maintenance screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

C

1

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Table of contents

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Table of contents

Symbols and warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Warnings concerning the handling of biological products . . . . . . . 4 Warnings concerning methodologies . . . . . . . . . . . . . . . . . . . . . . . 4 Warnings concerning the use of access codes . . . . . . . . . . . . . . . 6 Warning concerning the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Warnings concerning the cap piercing options . . . . . . . . . . . . . . . . 8 Warnings concerning the analyzer disposal . . . . . . . . . . . . . . . . . 8

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Table of contents

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Symbols and warnings

1

Symbols and warnings Symbols General warnings Warnings concerning the handling of biological products Warnings concerning methodologies Warnings concerning the use of access codes Warning concerning the analyzer Warnings concerning the cap piercing options Warnings concerning the analyzer disposal

1.1

Symbols On the analyzer

Symbol

Meaning Alternating current Direct Current Protective conductor terminal

Off (Power)

On (Power)

Caution, risk of electric shock

Caution, hot surface

Caution, consult the provided documentation for important cautionary information such as warnings and precautions Caution, biological risks

In vitro diagnostic medical device

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Symbols and warnings

Symbol

Meaning Medical device manufacturer

Separate collection: do not discard with other waste. For additional information about the disposal procedure, see chapter 1.8. On the disposables

Symbol

Meaning Do nor re-use

Storage temperature limit

Keep away from magnetic fields

Protective goggles and mask mandatory

Disposable gloves mandatory

Biological risks

In the documentation

Symbol

Meaning Caution, danger for the user or for the patient (risk of injuries or of incorrect results) Precautions to be observed in order to use the analyzer in accordance with its specifications and to avoid damaging the analyzer Additional information

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Symbols and warnings

Symbol

Meaning Message displayed on the screen Initial situation

1.2

General warnings The use of the STA Compact Max® requires training given by Diagnostica Stago or by its authorized representatives. In order to ensure the correct operation of the STA Compact Max®, it is imperative to acknowledge and to comply with any and all of the analyzer warnings, instructions and procedures contained in this manual. The compliance with any and all local legislations, regulations and norms related to biological acts and to medical biology laboratories applicable in the territory where the STA Compact Max® system is installed is required. All information, warnings, instructions and procedures contained in this manual and/or in all later versions updated by Diagnostica Stago as well as all legislation, regulations and norms relating to the use of medical in vitro diagnostic equipment in force and applicable for users locally (by “locally”, we understand the territory in which the STA Compact Max® system is installed) are hereinafter collectively referred to as the “Recommendations”. Under no circumstances Diagnostica Stago, its employees, its suppliers or the third parties mentionned in this manual shall be held responsible for an action of contractual liability, tort liability or any other action, for the security and the efficiency of the STA Compact Max® system or for any damage direct or indirect, material or immaterial, incidental or accessory, or of any kind, or of any prejudice, in all the cases non restrictively listed below: (I) in case of non respect of the recommendations described in this manual as well as the use of procedures that are not set forth by Diagnostica Stago, (II) in case of use of reagents other than those manufactured by Diagnostica Stago even if the use of said reagents associated with the STA Compact Max® system is specified in an adaptation protocol, (III) in case of use of tubes other than those specifically described in chapter 2.7.3 of this manual, (IV) in case of use of washed and/or used cuvettes, the reacting cuvettes being consumables intended for a single use, as well as cuvettes other than those manufactured by Diagnostica Stago and commercialized by Diagnostica Stago and/or by its official distributors, (V) in case of non accomplishment of the current and regular maintenance operations, calibration and support operations set forth in the present manual and permanently required to ensure the correct functionning and security of the STA Compact Max® system, (VI) in case the STA Compact Max® system has not been decontaminated in accordance with the decontamination procedures described in this manual.

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Symbols and warnings

1.3

Warnings concerning the handling of biological products For the handling of reagents, calibrator plasmas, control plasmas, and patients’ plasmas (hereafter referred to as “Products”), carefully read the notes that come with each Product. Prior to any intervention on the STA Compact Max® system and to ensure the safety of the staff working with biohazardous products, and to allow a proper execution of the biological assays, please observe the following instructions: (I) Oberve all warnings and recommendations, (II) Make sure that the STA Compact Max® is decontaminated in conformity with the decontamination procedures described in this manual, (III) Observe all standards and precautions imposed on laboratories for the execution of biological assays involving biohazardous products in accordance with the regulations in effect locally. For instance, the following precautions must be observed:

1.4

-

Do not eat, drink or smoke on the premises where these products are handled.

-

Immediately consult a physician if these products are ingested or put into contact with mucous membranes or skin lesions (wounds, cuts, etc.).

-

Use disposable gloves and handle all products as potentially infectious materials.

-

Eliminate all these products as if they were infected, in accordance with the law and the regulations locally in effect (for instance: autoclaving, incineration of disposable equipment, elimination of liquid wastes etc.)

Warnings concerning methodologies The non-observance of the conditions regarding methodologies may have consequences on the result accuracy and on the execution of any biological assays on the STA Compact Max® system, the following conditions must be observed: Pre-analytic conditions regarding the samples: in order to maintain the activity of various coagulation factors, the sample should be taken with care and following the professional standards in tubes with a specified concentration of citrate. The quality of the centrifugation and the storage temperature of the sample should also be carefully insured before the analysis: -

Plasma that is hemolysed, partially coagulated (presence of micro-clots), damaged by temperature changes or with bubbles on its surface may cause inaccurate results.

-

Plasma that has been frozen may contain interfering precipitates when thawed. These precipitates should be removed before measurement is performed.

Pre-analytic conditions regarding the products and the reagents: The laboratory must strictly comply with the instructions given by the manufacturer in the product and reagent inserts. Poor preparation of the reagent regarding reconstitution volume, stabilization time, stirring as well as the presence of bubbles or the accidental presence of a magnetic rod may lead to incorrect results. The ISI value of the thromboplastin used for the determination of the prothrombin time should be the one indicated on the assay value insert of the STA product.

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Symbols and warnings

Any change in lot, any software update - like any intervention - should give rise to verification of the ISI value. Analyzer methodology and condition: The laboratory must make sure that the methodology complies with the instructions given by the reagent manufacturer in the inserts, especially regarding volumes to be used, incubation times, rinsing solutions, buffers, etc. It is the laboratory's responsibility to correctly enter the bar codes and to choose the appropriate methodology for a given analysis. Moreover, the analyzer brings results from biological materials and although these materials are implemented and measured by highly sophisticated computer-controlled automated systems in order to optimize reliability and safety, it is impossible to guarantee an error rate of zero. The laboratory must ensure that the maintenance is performed on a regular basis and in conformity with the recommendations described in this manual. Conditions regarding the confirmation of the methods and procedures -

Methodologies provided by Diagnostica Stago have been individually validated for the STA Compact Max® analyzer and possible interference among products has been estimated. If the laboratory decides to use other lines of reagents and methodologies that have not been confirmed by Diagnostica Stago as compatible with the STA Compact Max® analyzer, a validation of the new system is required. This confirmation will allow, on the one hand, to check the method characteristics (see point 1 in the bibliography) and, on the other hand, to control the interference of new products on existing ones and vice versa.

-

When duplicate analyses are carried out on the same sample, the error rate is mathematically of about one in one hundred million, which is not null but can be considered to be negligible (see point 2 in the bibliography). For instance: Studies conducted on prothrombine using Neoplastin Plus reagent have shown that the inconsistency rate (difference between two results >15%) on duplicate analyses is less than one in ten thousand. This rate can be compared with the error rate which could be observed for analyses in single determination. Note that when the incidence of error is below one in ten thousand, it becomes difficult to qualify an error rate experimentally and accurately.

-

Results given by the analyzer must always be analyzed according to the patient’s history, to the clinical examination and to any other biological results.

Bibliograhpy 1. VASSAULT A. et al. : “Protocole de validation de techniques” (Protocol for validation of techniques). Ann. Biol. Clin., 44, 686 - 745, 1985. 2. KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B. : “A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests”. Am. J. Clin. Pathol., 102, 2, 242-246, 1994.

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Symbols and warnings

1.5

Warnings concerning the use of access codes The different functions of the STA Compact Max® analyzer can be sorted into 2 categories: -

Routine functions (example: running calibration).

-

change functions (example: creation or modification of methodologies. See above, chapter 1.4).

All these functions are protected by access codes (see 7.3.4). The use of routine functions has no impact on the results obtained. However, the use of change functions may affect result accuracy. Therefore, it is required that each laboratory assesses the consequences of the use of the different functions prior to the attribution of access codes.

1.6

Warning concerning the analyzer The STA Compact Max® may only be installed by personnel duly authorized by Diagnostica Stago or by its authorized representatives. Once the STA Compact Max® has been switched off, wait for 30 seconds, at least, before switching it back on. The STA Compact Max® was made and tested according to the CISPR 11 (International Special Commitee On Radio Interference) for class A equipment. In a domestic environment, the STA Compact Max® may cause radio interferences. In this case, measures will have to be taken to reduce these interferences. The analyzer complies to the EN 61326-2-6:2006 standard. The electromagnetic environment should be evaluated before turning on the analyzer. Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones, unprotected sources of radiofrequency...) as they may interfere with the operating conditions of the analyzer. In order to avoid any risk of electrical shock, it is absolutely necessary to follow the procedures described in this manual. In order to avoid any electrical shock when the STA Compact Max® is turned on, never insert your hands, tools or any other object where these components are located: -

LEDs (located behind the left front door),

-

Fuses (located on the left side of the STA Compact Max®).

Make sure that the STA Compact Max® is positioned in such a way that it can be easily unplugged. It is absolutely necessary to check that all opening frames of the STA Compact Max® (listed below) are closed before power is turned on. During operation, it is absolutely necessary to close them as soon as any handling requiring them to be opened is finished:

6/8

-

right side door,

-

right front door,

-

left front door,

-

front panel,

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-

products drawer,

-

sample drawer,

-

cuvette disposal drawer.

The front panel of the STA Compact Max® must be kept closed. Do not obstruct the switch detecting the front panel presence. If the front panel of STA Compact Max® is open, the STA Compact Max® detects it and immediately stops ongoing analyses. Mind the residual movements of the analyzer arms. Never touch the moving parts of the analyzer. Avoid touching the tip of the piercing needle and decontaminate it before proceeding to its replacement. Never pass the stylet through the piercing needle. During the lamp replacement, in order to avoid any risk of burn: allow the lamp to cool before removal. Handle the Peltier reservoir with care. It contains methanol and ethylene-glycol. In order to avoid any injury or intoxication: -

Do not inhale or swallow.

-

Use disposable gloves, mask, protective clothing and protective goggles.

-

Refer to the safety data sheet available on the Internet: http://www.stago.com

For most of the available screens on the STA Compact Max®, printing of the information is ordered either by pressing a function key (F6) or by selecting the “Print” function. However, in some cases, especially when there is a malfunction, it may be necessary to obtain a hard copy of the screen. If testing is in progress on the STA Compact Max®, this type of command can disrupt the smooth course of the test flow and may even lead to stoppage of the analyzer. For safety reasons, screen hard copy can only be accessed by the Print Screen key. This command should only be used in case of absolute necessity, for instance, when such a recommendation appears on the STA Compact Max® monitor and/or when such a request is made by your local authorized Service Representative. If the analyzer must be switched off for more than one week, follow the procedure described in paragraph 4.5. Before switching the analyzer on, follow the same decontamination procedure then place the used liquid container and the cuvette waste back in their proper place. Check the Peltier reservoir level too (see 8.3.3). Static electricity can damage sensitive electronic components inside the analyzer. Before and during any operation for which a door or cover of the analyzer must be open (when performing the maintenance for instance), the user must discharge their body from static electricity. In order to discharge the stored static electricity, the user must touch an unpainted metal surface (frame or protective plate). The analyzer must remain plugged to a grounded outlet during the whole operation.

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Symbols and warnings

1.7

Warnings concerning the cap piercing options Diagnostica Stago shall not be held responsible if the recommendations are not observed. The types of capped tube compatible with the cap piercing option are described in document 0932011. Contact your local supplier to ensure that you have the latest issue of this document. Fully respect sample drawing conditions following recommendations in force as given by tube suppliers and CLSI guidelines (eg. a tube incorrectly filled may contain vacuum and may cause incorrect pipetting when the cap is pierced). Do not recap an uncapped tube (problem of overpressure in the tube) that you want to load in the instrument. Make sure that there are no bubbles on the plasma surface. When the volume of a reagent has to be changed: respect the procedure described in the user documentation. The minimum volume displayed in the methodologies is defined with a standard needle. The cap piercing system uses another type of needle which increases this minimum volume. With the cap piercing option, the minimum volumes are the following: -

2.2 ml for the diluent and the STA® Desorb U

-

0.6 ml for controls and calibrators

-

200 µl for STA® - microcontainers (samples)

-

280 µl for STA® - microcups (products)

Diagnostica Stago recommends the use of STA® - microcups for controls and calibrators. Sample tubes which have been tested and removed from the analyzer must have their caps removed if they are going to be reloaded, otherwise there is a risk of an erroneous result.

1.8

Warnings concerning the analyzer disposal Waste Electrical and Electronic Equipment (WEEE). The use of this symbol implies that the analyzer must not be disposed of with household waste; that it must be subject to separate collection and that it has been put on the market after 13 August 2005.

For more information about the appropriate disposal of the analyzer (waste sorting, collection, processing of analyzer waste) contact the local authorities, the manufacturer or the distributor who sold this analyzer.

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Table of contents

2

System presentation . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.1

Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2.1 Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

2.2.2 Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

2.3

Chronometry Measurement Principle. . . . . . . . . . . . . . . . . . .

2

2.4

Photometry Measurement Principle . . . . . . . . . . . . . . . . . . . .

3

2.5

STA Compact Max® description . . . . . . . . . . . . . . . . . . . . . .

6

2.5.1 STA Compact Max®, overall view . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

2.5.2 STA Compact Max®, front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

2.5.3 STA Compact

Max®,

rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

2.5.4 STA Compact

Max®,

left side view . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

2.5.5 STA Compact Max®, right side view . . . . . . . . . . . . . . . . . . . . . . . . . .

12

2.6

General Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

2.6.1

Sample Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

2.6.2 Product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

2.6.3 Measurement plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

2.7

Technical specifications STA Compact Max® . . . . . . . . . . . .

18

2.7.1 Technical specifications - Part 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

2.7.2 Technical specifications - Part 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

2.7.3 Technical specifications - Part 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

2.7.4 Technical specifications - Part 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

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System presentation

2

System presentation Definition, see 2.1 Installation, see 2.2 Chronometry Measurement Principle, see 2.3 Photometry Measurement Principle, see 2.4 STA Compact Max® description, see 2.5 General Principles, see 2.6 Technical specifications STA Compact Max®, see 2.7

2.1

Definition The STA Compact Max® system is a medical device for in vitro diagnosis, composed of a laboratory analyzer and a software designed to be used with consumables and reagent products. The STA Compact Max® system is designed to perform in vitro analyses for diagnosis and monitoring of pathologies linked to hemostasis.

2.2

Installation Installation requirements, see 2.2.1 Installation procedure, see 2.2.2

2.2.1

Installation requirements Space requirements: Height

996 mm

39.2 "

Width

2530 mm

99.6 "

Depth

1100 mm

43.3 "

Analyzer for indoor use. Respect the ventilation space given by the two end stops at the back of the analyzer.

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System presentation

Power supply: Voltage - Tolerance - Rating

100 V~ (± 10%) 1400 VA maximum 115 V~ (± 10%) 1400 VA maximum 230 V~ (± 10%) 1400 VA maximum

Frequency

50 to 60 Hz (47 to 65 Hz)

See also 1.6 Warning concerning the analyzer

2.2.2

Installation procedure The STA Compact Max® must be installed only by a representative of Diagnostica Stago or of their official distributors. Moreover, if the STA Compact Max® has to be moved, this must be imperatively performed by an authorized representative of Diagnostica Stago or of their accredited distributor who has the required tools to handle the analyzer. See also 1.6 Warning concerning the analyzer

2.3

Chronometry Measurement Principle The principle consists in measuring the variations of the ball oscillation amplitude through inductive sensors. The ball has a pendular movement obtained: -

thanks to the two curved rail tracks of the cuvettes

-

and an alternate electro-magnetic field created by two independent coils.

The oscillation amplitude is constant when the environment has a constant viscosity. The oscillation amplitude decreases when the environment viscosity increases.

Fig. 1 - Principle of measurement system

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System presentation

Legend: 1. Emitting measurement coil 2. Receiver measurement coil 3. Drive coils 4. Ball 5. Cuvette The intensity of the magnetic field varies depending on the analyses to be carried out (PT, APTT, etc.) and on the expected clot. The detection system of the oscillation amplitude variations is based on two measurement coils. The emitting coil emits an electro-magnetic field. The signal received by the receiver coil depends on the position of the ball inside the cuvette. An algorithm uses these magnetic field variations to calculate the oscillation amplitude variations to accurately determine the clotting times.

Fig. 2 - Amplitude of the ball oscillation during clotting

Legend: 1. Amplitude of the ball oscillation 2. Clotting

2.4

Photometry Measurement Principle The detection of chromogenic assays on the STA Compact Max® is based on the absorbance (optical density: O.D) of monochromatic (405 nm or 540 nm) light passing through the cuvette as a chromogenic reaction takes place.

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System presentation

The principle of absorbance measurement is depicted by the diagram below. Fig. 3 - Principle of Absorbance Measurement

Incident light (I0) entering the cuvette is partially absorbed by the reaction mixture as it passes through. The transmitted light (I1 = I + Ip) is measured, and converted to absorbance by the following equation. The effect of stray light (Ip) is eliminated by taking two fairly close measurements of the light transmitted. I1 = I + Ip (first measurement which includes incident light and stray light) I2 = Ip (second measurement while blocking the incident light, corresponds to the stray light). When I2 is substracted from I1, the result is I, which is only the light transmitted from the incident light. Ip is assumed to remain constant between the two measurements. Absorbance is obtained with the following equation: A= -log (I/I0)

Note: log decimal

Incident light (I0) is provided by a tungsten-halogen lamp, and is made monochromatic by passing through a 405 nm or 540 nm interference filter put in a mobile filter holder. These items are inside the optical module. A system of optical fibers carries the transmitted monochromatic light from the optical module to the measurement head, see illustration hereafter.

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System presentation

Fig. 4 - Principle of Optical Module

Legend: 1. Measuring head 2. Reference fiber 3. Sensor 4. Analog measurement board 5. Measurement CPU board 6. RS232 7. PC 8. Harness of 5 optical fibers 9. Photometry module with set of switchable filters The Beer-Lambert law is applied to convert absorbance to concentration of the substance being measured: A=εIC A = Absorbance

ε = Molecular extinction coefficient I

= Optical path length

C = Concentration Concentration of the chromophore being measured in a homogeneous mixture is proportional to the absorbance. All the optical density measurements are made with regard to the reference fiber.

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System presentation

2.5

STA Compact Max® description STA Compact Max®, overall view, see 2.5.1 STA Compact Max®, front view, see 2.5.2 STA Compact Max®, rear view, see 2.5.3 STA Compact Max®, left side view, see 2.5.4 STA Compact Max®, right side view, see 2.5.5

2.5.1

STA Compact Max®, overall view

Fig. 5 - STA Compact Max®, overall view

Legend: 1. Touch screen 2. Volume adjustment button Lowering the STA Compact Max® volume may make alarms inaudible, especially those accompanying the opening/closing of drawers and all the warnings messages.

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System presentation

3. CD/DVD ROM drive 4. USB port 5. Front cover 6. Right front door (access to the syringe and to the cuvette roll) 7. Cuvette Disposal Drawer 8. Product drawer 9. Sample drawer 10. Left front door and barcode reader The operators must discharge themselves of static electricity before accessing this part of the analyzer. Touch the unpainted metallic part of the analyzer identified with mark 6 in figure 6.

11. Mouse 12. Keyboard

2.5.2

STA Compact Max®, front view

RISk OF BIOLOGICAL CONTAMINATION Observe the usual precautions for the handling of tubes and containers as they may contain biohazardous material. RISK OF INJURY Do not touch the moving parts.

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System presentation Fig. 6 - , front view

Legend: 1. USB port 2. CD Rom drive/recorder 3. Volume adjustment button 4. Barcode reader 5. Electronic boards 6. Area enabling to discharge the stored static electricity 7. Sample drawer 8. Product drawer 9. Cuvette Disposal Drawer 10.Pipetting head 11.Cuvette roll drawer (Cuvette roll change, see 3.2.1) 12.Syringe (Syringe Teflon® Tip replacement, see 8.4.3)

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System presentation

2.5.3

STA Compact Max®, rear view

Fig. 7 - STA Compact Max®, rear view

Legend: 1. External communications (see figure 8 hereafter) 2. Air Filter 3. Air vents

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System presentation

Fig. 8 - External communications (details of zone 1, figure 7)

Legend: 1. USB ports Avoid disconnecting the screen and the printer from the analyzer. They must always be connected to the same USB ports.

2. PS/2 connector for the mouse 3. Parallel port 4. Monitor connection 5. PS/2 connection for keyboad 6. Host computer connection 7. Ethernet network connection

The STA Compact Max®, the monitor and the printer must be switched off before being connected.

All the devices connected to the STA Compact Max® must comply with IEC 60950, EN 55022 class B and EN 55024 standards.

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System presentation

2.5.4

STA Compact Max®, left side view

Fig. 9 - STA Compact Max®, view from left side

Legend: 1. Air vents 2. Identification label 3. WEEE label 4. Warning sticker (see 1.8) 5. Sticker for China RoHS 6. Main fuses sticker 7. Main fuses (see 8.5.6) 8. Voltage selector 9. Cord socket for power supply 10. On/off switch 11. secondary fuses sticker 12. Secondary fuses (see 8.5.7)

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System presentation

Switch off the STA Compact Max®, the monitor and the printer before replacing the fuses. Replace the fuses with fuses sharing the same reference.

2.5.5

STA Compact Max®, right side view RISk OF BIOLOGICAL CONTAMINATION Observe the usual precautions for the handling of potentially biohazardous material. RISK OF INJURY Do not touch the moving parts.

Fig. 10 - STA Compact Max®, view from right side

Legend:

12/22

1. Optical Module

4. Used liquid container

2. Peltier reservoir

5. Washing Solution

3. STA® Cleaner bottle

6. Vacuum Reservoir

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System presentation

2.6

General Principles Sample Drawer, see 2.6.1 Product drawer, see 2.6.2 Measurement plate, see 2.6.3

Fig. 11 - Analysis area of the STA Compact Max®

Legend: 1. Pipetting Head Equipped with 3 Needles

9. Measurement area (4 positions)

2. Needle No.1 (Samples)

10. Cuvette Loading Station

3. Needle No.2

11. Suction Head

4. Needle No.3

12. Cuvette Roll Drawer

5. Pneumatic Jack

13. Cuvette Disposal Drawer

6. Washing Wells

14. Product drawer

7. Measurement Station

15. Sample Drawer

8. Incubation area (16 positions) STA Compact Max® allows the performance of chronometric analyses (measurement of coagulation time), colorimetric analyses or immunological analyses on plasma samples.

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System presentation

The sample tubes and the diluents are loaded in the sample drawer where their positions are automatically detected by the Positive Identification System. The control plasma vials, the calibration plasma vials as well as the reagent vials are loaded in the product drawer. The position of each vial is also automatically detected by the Positive Identification System. Sample plasmas, control plasmas as well as calibrator plasmas are pipetted by needle No.1 (pipetting head), then they are added in a cuvette at an incubation position. Reagents to be added before the first incubation are pipetted by needle No.2 of the pipetting head, then they are distributed in the related cuvette in incubation position. Reagents to be added after the first incubation (mainly the start reagents) are pipetted by needle No.3 of the pipetting head. If a preheating is necessary, the reagents are moved from needle No.3 up to heating tube No.3 (this one being just above). Then, with or without preheating, those reagents are also added in the cuvette. A level detection system on each needle ensures accurate and precise dispensing of fluid volumes. Carry over is minimized by rinsing the interior as well as the exterior of the needles, each in its own well. Cuvettes are loaded in the STA Compact Max® through a roll of 1,000 cuvettes. At the cuvette loading station, they are placed one-by-one in a shuttle. This shuttle is then moved to the measurement station by a system based on a pneumatic jack. At this station, the suction head picks up the cuvette and transfers it to the incubation zone. This same head then transfers the cuvette from the incubation zone to the measurement zone then from the measurement zone to the cuvette disposal container. The incubation area and the measurement area are included in the same block. These operating principles enable the instrument to process each analysis independently, and offer a throughput that is virtually independent of the analysis time.

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System presentation

2.6.1

Sample Drawer

Fig. 12 - Sample drawer cassette

RISk OF BIOLOGICAL CONTAMINATION In order to avoid any risk of contamination For the handling of biohazardous materials, observe the proper precautions in accordance with local existing regulations (for instance: wear disposable gloves). RISK OF INJURY Do not touch the opening and closing drawers

Legend: 1. Zone for Pediatric tubes 2. Position for diluent bottle 3. Position for 5ml tubes 4. Status LED LED on = tube present and being processed LED off = no tube detected Blinking LED = tube which analyses are completed

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2.6.2

Product drawer

Fig. 13 - Product drawer cassette

Legend: 1. Status LED LED on = tube present and being processed LED off = no tube detected Blinking LED = tube which analyses are completed 2. Stirring positions

RISk OF BIOLOGICAL CONTAMINATION Observe the usual precautions for biohazardous materials while manipulating tubes or cleaning the sample drawer (for example, wear disposable gloves). RISK OF INJURY Do not touch the opening and closing drawers

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System presentation

2.6.3

Measurement plate

Fig. 14 - Measurement plate

RISk OF BIOLOGICAL CONTAMINATION Observe the usual precautions for biohazardous material while cleaning the measurement plate

Legend: 1. Incubation area (16 positions) 1-1: position 1 1-16: position 16 2. Measurement area, 4 chronometric and photometric measurement heads 2-1: position 1 2-4: position 4

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System presentation

2.7

Technical specifications STA Compact Max® Technical specifications - Part 1, see 2.7.1 Technical specifications - Part 2, see 2.7.2 Technical specifications - Part 3, see 2.7.3 Technical specifications - Part 4, see 2.7.4

2.7.1

Technical specifications - Part 1 Type -

In vitro diagnosis instrument

-

Multi-test analyzer

-

Operating mode: patient by patient

-

Chronometrie

-

Photometry: colorimetry and immunology

Operating Conditions -

For indoor use

-

Impact resistance: according to current standards

-

Temperature: + 15°C to + 32°C (59°F to 89.5°F)

-

Relative humidity: 20% to 80% without condensation

-

Altitude: < 2 000 m

-

No incident light on the open drawer

Storage and transport conditions -

Temperature: -20°C to +60°C (-4°F to +40°F)

-

Maximum temperature deviation: 20°C per hour

-

Relative humidity: 20% to 80% without condensation

Environment -

Sound level: 70 dBA maximum

-

Heat dissipation when ambiant temperature is 20°C: - 230V - 100V : 1400 Whr (4778 BTU) - 115V: 1000 Whr (3413 BTU)

Dimensions of STA Compact Max® -

Height: 705 mm (27.75 in)

-

Width: 970 mm (38.18 in.)

-

Depth: 730 mm (28.73 in) - lower part of the analyzer 685 mm (26.97 in)

Weight of the STA Compact Max® -

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140 kg (331 lbm)

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System presentation

Space requirements -

Height: 996 mm (36.85 in.)

-

Width: 2530 mm (99.6 in.)

-

Depth: 1100 mm (43.3 in.)

Power supply

2.7.2

-

Voltage and tolerance: 230 V (± 10 %) - 115 V (± 10 %) - 100 V (± 10 %)

-

Frequency: 50/60 Hz

-

Rating: 1400 VA

-

Number of power sockets: one 15 A plug

-

2 main fuses (see 2.5.4)

-

8 secondary fuses (see 2.5.4)

-

Fuse protection: yes

-

Inverter needed: no

-

Results of sudden loss of supply: loss of the analysis in progress, possible alterations of the hard disk

Technical specifications - Part 2 The STA Compact Max® system consists exclusively of the analyzer and the keyboard. Standards For STA Compact Max® 230V: EC marking (in accordance with European directive 98/79/EC) -

EN 61326-2-6:2006 (Class A for emissions)

-

IEC 61010-1 and IEC 61010-2-101

For STA Compact Max® 115V: -

FCC: 47 CFR Part 15 (class A)

-

UL 61010-1

-

UL file No.E192098

Classification -

Type of protection against electric shock: Class 1 equipment

-

Overvoltage category II

-

Degree of protection against harmful ingress of water: ordinary equipment (enclosed equipment without protection against ingress of water)

-

Pollution level: 2

-

Recommended disinfection method: see 8.8

-

Degree of safety of application: equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

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System presentation

-

Mode of operation: continuous operation All the devices connected to the STA Compact Max® must comply with IEC 60950, EN 55022 class B and EN 55024 standards.

2.7.3

Technical specifications - Part 3 Sample Management -

One drawer of 96 centrifuged primary tubes - Diameter: 3 ml tubes : 11 mm (0,43 in.) 5 ml tubes: 11 to 13,4 mm (0.43 to 0.53 in.) - length: 65 to 100 mm (2.56 to 3.94 in.)

-

Label reading by barcode reader

Product management1 -

Drawer with 45 positions for different sizes: - 11 positions for vials of 10/15/20 ml (diam. 30 mm) - 12 positions for vials of 4/6 ml (diam. 23 mm) - 22 positions for vials of 1/2 ml (diam. 18 mm)

-

1 diluent position (diam. 30 mm) in the sample drawer

-

Label reading by barcode reader

-

Control of stability and volume

1. Products: controls, calibrators, reagents, diluents and Desorb solution. Diluent is loaded in position 8 of the sample drawer.

Measurement principle -

Analytical modes: clotting and photometry

-

Clotting, change in medium viscosity detected by electromagnetic sensors

-

Photometry - Light Source: Tungsten-halogen lamp - Colorimetry and immunology: monochromatic measurement of O.D at 405nm and 540nm

Methodologies 80 methodologies that may be modified Pipetting Based on a 205µl Hamilton syringe Cuvettes -

The cuvette is used for incubation and measurement

-

Rolls of 1000 cuvettes with stainless steel balls - Maximum usable volume: 400µl

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System presentation

- Minimum usable volume: 150µl for clotting assays and 250µl for photometry assays - Identification by bar code reader -

Cuvette authorizing a pendulum movement of the ball

Test Performance Refer to documentation included in reagent boxes.

2.7.4

Technical specifications - Part 4 Data processing -

Microprocessor: intel Celeron M 1 GHz

-

Memory: 512 Mo (minimum)

-

Hard disk: 80 Go minimum

-

Operating system: Windows Embedded Standard 2009

Connection -

Network connection: RJ45 port (Ethernet 10/100Mbps)

-

SIL connection: serial port RS232 (ASTM protocol)

Interfaces -

3 USB 2.0 ports at the rear for USB device (touch screen, USB printer, mouse)

-

One 2.0 USB port at the front for a USB flash drive

-

1 PS/2 port for the mouse

-

1 PS/2 port for the keyboard

-

1 RS232 serial port: communication with SIL (ASTM protocol)

-

1 VGA port for the display

-

One 10/100 Mbps Ethernet port

Touch screen Characteristics

Value

Technology

LCD

Active surface diagonal

22" (55,9 cm)

Nominal resolution

1680 x 1050

Main power

115 V to 230 V 50Hz to 60Hz

Consommation

< 110W

Electromagnetic compatibility

Measurement: class B (EN 55022 class B) Immunity: residential (or EN 55024)

Security

CEI60950

Video bandwidth

> 75 MHz

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System presentation

Characteristics

Value

Horizontal frequency

30 to 83 KHz

Vertical frequency

56 to 75 Hz

Netting

< 0.30 mm

Horizontal view angle

>120°

Vertical view angle

> 90°

Luminosity

> 200 cd/m2

Contrast

100: 1 to 400 : 1

Response time

< 40 ms

Keyboard -

USB keyboard (AZERTY or QWERTY depending on the language)

-

Approved: CSA, UL

Printer

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-

List of compatible printers: contact Diagnostica Stago or one of its official distributors

-

The printer cable must meet the printer notice requirements

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Table of contents

3

Analyzer preparation . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.1

Turning the analyzer on . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2

Loading the disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2.1 Loading the cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

3.2.1.1 Identifying the cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

3.2.1.2 Replacing the cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

3.2.1.3 Replacing the cuvette disposal bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

3.2.2 Loading the washing solution bottle . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

3.2.2.1 Removing the used liquid container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

3.2.2.2 Replacing the used liquid container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

3.2.2.3 Installing the washing solution bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

3.3

10

Loading products and samples . . . . . . . . . . . . . . . . . . . . . . .

3.3.1 General information on loading operations . . . . . . . . . . . . . . . . . . . . .

10

3.3.1.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

3.3.1.2 Loading areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

3.3.1.3 Accessing the loading window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

3.3.2 Identifying and loading products . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

3.3.2.1 Barcode identification and loading of products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

3.3.2.2 Manual identification and loading of products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

3.3.3 Identifying and loading diluents (sample drawer) . . . . . . . . . . . . . . . . .

16

3.3.3.1 Barcode identification and loading of diluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

3.3.3.2 Diluent manual identification and loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

3.3.4 General information on sample loading . . . . . . . . . . . . . . . . . . . . . . . .

19

3.3.4.1 Sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

3.3.4.2 Automatic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

3.3.4.3 Manual mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

3.3.4.4 Selecting methodologies and defining methodology profiles . . . . . . . . . . . . . . . . . . .

21

3.3.5 Identifying and loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

3.3.5.1 Barcode identification and loading of samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

3.3.5.2 Manual identification and loading of samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26

3.3.6 Modifying loaded products or samples . . . . . . . . . . . . . . . . . . . . . . . .

27

3.3.6.1 Modifying products onboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

3.3.6.2 Modification procedure for the sample drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

3.3.7 Unloading samples or products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

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Table of contents

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Analyzer preparation

3

Analyzer preparation Turning the analyzer on, see 3.1 Loading the disposables, see 3.2 Loading products and samples, see 3.3

3.1

Turning the analyzer on

The analyzer is designed to work around the clock 24 hours a day. However, the analyzer must be turned off once a week during the preventive maintenance.

" Switch the printer on. " Switch the monitor on. " Switch on the analyzer (I) (switch located on the left side) (voir 2.5.4).  The analyzer makes automation and software checkings. If a problem is detected, an error message is displayed.  The home screen appears. " Click Continue.  The Test panel appears. " Wait 25 minutes to allow the product drawer temperature to be stabilized.  The analyzer is ready for use.

3.2

Loading the disposables Loading the cuvette roll, see 3.2.1 Loading the washing solution bottle, see 3.2.2

3.2.1

Loading the cuvette roll Identifying the cuvette roll, see 3.2.1.1 Replacing the cuvette roll, see 3.2.1.2 Replacing the cuvette disposal bag, see 3.2.1.3

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Analyzer preparation

RISk OF BIOLOGICAL CONTAMINATION RISK OF INCORRECT RESULTS Cuvettes are disposable consumables. Diagnostica Stago cannot be liable for any damages whatsoever, direct, indirect, material or immaterial if washed and/or reused cuvettes and/or cuvettes other than those manufactured and distributed by Diagnostica Stago or distributed by its official distributors are used.

After changing the cuvette roll, the cuvette bin must systematically be emptied (see 3.2.1.3).

3.2.1.1

Identifying the cuvette roll

Test Panel screen " Click Products then Loading cuvettes.  The cuvette roll identification window appears: NOTE: the cuvette roll loading window is also available from certain error messages.

Fig. 1 - Cuvette roll identification window

" One after the other, pass the two cuvette roll barcodes in front of the barcode reader. Barcodes allow a good follow-up of cuvette rolls.  When a barcode passes in front of the reader, the system beeps.  When a barcode is read, the corresponding area of the window is filled in.

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Analyzer preparation

In case of barcode reading failure, cuvettes rolls may be manually identified. Type the data located under the barcodes. Manual identification can lead to typing errors. It is used under complete responsability of the user.

" Click Confirm.  The window Information concerning the reel appears.

Fig. 2 - Window Information concerning the reel

" In the field Number of cuvettes in the reel, indicate the number of cuvettes remaining in the cuvette roll if it is less than what appears in the window. " Click Confirm.

3.2.1.2

Replacing the cuvette roll All new cuvette rolls are supplied with a cuvette take up reel fixed to the cuvette roll by a film on which cuvettes are set. " Follow the instructions hereafter to replace the cuvette roll.

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Fig. 3 - Loading the roll of cuvettes

Removing the empty roll 1

Open the right front door.

2

Pull the cuvette roll drawer out.

3

Raise the catch holding the reel and the catch holding the cuvette roll.

4

Remove the reel by sliding it off its spindle.

5

While holding the reel with one hand, guide the plastic film under the positioning roller.

6

While still holding he reel with one hand, remove the cuvette roll by sliding it off its spindle then throw the empty roll away. Remove the plastic foam out of the loading rail if it is detached from the plastic film.

Installing the new cuvette roll: 7

Hold the roll so that the reel is on the right. Slide the cuvette roll along its spindle, lower the catch holding the roll.

8

Guide the film under the two positioning rollers. Do not twist the film. The film adjust itself in the slide.

9

Slide the cuvette roll along its spindle, lower the catch holding the roll. Turn the take up reel as indicated in the displayed message.

10

Push the cuvette roll drawer back in and close the right front door.

 A message suggesting an automatic test appears. " Click Yes to accept the automatic test.

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Analyzer preparation

 A message informing that a test is being carried out appears. " Proceed with the cuvette disposal bag replacement.

3.2.1.3

Replacing the cuvette disposal bag

RISk OF BIOLOGICAL CONTAMINATION In order to avoid any risk of contamination For the handling of biohazardous materials, observe the proper precautions in accordance with local existing regulations (for instance: wear disposable gloves).

Each time the cuvette roll is changed, the cuvette bin must be emptied. Fig. 4 - Loading the cuvette roll

" Remove the cuvette disposal drawer. " Close the plastic bag with its thread. NOTE: Cuvette disposable bag do not all close the same way. " Take the bag out and discard it following the regulations in force locally. " Take one of the plastic bags provided with the cuvette roll box. " Open the plastic bag and place it into the cuvette disposal drawer. " Press the bag to the bottom of the cuvette disposal drawer. " Fold the plastic bag over the edges of the cuvette disposal drawer. " Adjust the plastic bag in such a way as to avoid folds.

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Analyzer preparation

" Put the cuvette disposal drawer back in place, pushing it fully back in and making sure it is properly adjusted on its rail. " Click Confirm.  A message indicating the end of the cuvette roll loading procedure is displayed. Do not obstruct the switch detecting the cuvette disposal bin presence.

 The Test panel reappears.

3.2.2

Loading the washing solution bottle Removing the used liquid container, see 3.2.2.1 Replacing the used liquid container, see 3.2.2.2 Installing the washing solution bottle, see 3.2.2.3 Ref.: 00973 STA® Cleaner Required equipment: paper towel

RISk OF BIOLOGICAL CONTAMINATION In order to avoid any risk of contamination For the handling of biohazardous materials, observe the proper precautions in accordance with local existing regulations (for instance: wear disposable gloves).

3.2.2.1

Removing the used liquid container

RISk OF BIOLOGICAL CONTAMINATION In order to avoid any risk of contamination For the handling of biohazardous materials, observe the proper precautions in accordance with local existing regulations (for instance: wear disposable gloves).

Test Panel screen " Click Products then Washing liquid.  The Loading washing solution screen appears.

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NOTE: the window for the loading of the washing solution is also available from certain error messages. Fig. 5 - Loading washing solution window

" Open the right side door. " Carefully lift the used liquid container represented in yellow on the screen (bottle on the right). " Remove the used liquid container plug. Place a paper towel under the plug. " Completely release the used liquid container. " Click Confirm. " Replace the original cap on the used liquid container. " Dispose of the used liquid container in accordance with the regulations in force locally RISK OF INCORRECT RESULTS Mark the used liquid container appropriately, never use it as new STA® Cleaner bottle, as it may lead to wrong results.

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3.2.2.2

Replacing the used liquid container The empty STA® Cleaner container becomes the new used liquid container.

Loading washing solution window Fig. 6 - Loading washing solution window

" Carefully lift the empty STA® Cleaner bottle (bottle on the left). " Remove the plug. Place the tip of the plug tubing in a container to avoid any risk of contamination. Use paper towel if necessary. " Empty the bottle. " Place the empty bottle in front of the right-hand side position and put the plug on the empty bottle. " Put the empty bottle in place. The closing of the switch detecting the presence of the bottle should be heard. Do not obstruct the switch detecting the used liquid container presence.

" Click Confirm.

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3.2.2.3

Installing the washing solution bottle

Loading washing solution window Fig. 7 - Loading washing solution window

" Take a new STA® Cleaner bottle The new STA® Cleaner bottle must be at room temperature.

RISK OF INCORRECT RESULTS Do not modify the formulation of the STA® Cleaner, as it may lead to wrong results.

" Remove the STA® Cleaner bottle cap and store it for future use. " Place the empty bottle of STA® Cleaner in front of the left-hand side position and put the plug on the empty bottle. " Put the bottle in place. The closing of the switch detecting the presence of the bottle should be heard. " Click Confirm. " If a new bottle is used, click Confirm to validate the indicated volume (2500 ml). Otherwise, type the remaining volume, then click Confirm. " Close the right side door.

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3.3

Loading products and samples General information on loading operations, see 3.3.1 Identifying and loading products, see 3.3.2 Identifying and loading diluents (sample drawer), see 3.3.3 General information on sample loading, see 3.3.4 Identifying and loading samples, see 3.3.5 Modifying loaded products or samples, see 3.3.6 Unloading samples or products, see 3.3.7

3.3.1

General information on loading operations Warnings, see 3.3.1.1 Loading areas, see 3.3.1.2 Accessing the loading window, see 3.3.1.3

3.3.1.1

Warnings RISK OF INCORRECT RESULTS Prior to any loading operation, check the following points:

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-

Reagents and other products (controls, calibrators, diluents and desorb solutions): clean any foam that may detected.

-

Samples: only use tubes after centrifugation. Make sure there is sufficient volume of plasma. Make sure there is no foam, no clot, nor micro-clot that might interfere with the results.

-

For all loading and unloading operations, the proper precautions for handling biohazardous materials should be observed in accordance with local existing regulations: for example, use disposable gloves, mask and protective goggles.

-

During loading operations, handle only one tube or one vial at a time to avoid confusion.

-

When changing a lot, make sure there are no ongoing analyses, otherwise, delete them.

-

Carefully read the documentation provided with each product (reagents, controls, calibrators, diluents, Desorb solutions) and follow all the instructions.

-

To comply with package insert requests related to the intrinsic coagulation pathway deficient plasmas (VIII, IX, XI, XII) as well as with those related to the reagent STAStaclot® Protein S, i.e.: "The factor assays of the patients samples follow the completion of assay calibration and are performed within the timeframe that is compatible with the stability of related factor in plasma", the following procedure must be observed:

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- before starting the loading of the samples, block the required methodology (example: factor VIII) (see 6.5), - Run the calibration for the required methodology (example: factor VIII), - Change to Urgent, any sample tube with the required methodology (example: factor VIII) in its working list: either, while loading the sample (voir 3.3.4) or while consulting Patient files (see 6.3) - As soon as calibration of the required methodology (example:factor VIII) is validated, unblock that methodology (example: factor VIII) (see 6.5). -

Manual identification can lead to typing errors. It is used under complete responsibility of the user.

RISk OF BIOLOGICAL CONTAMINATION, RISK OF INJURY and RISK OF INCORRECT RESULTS -

Vials and sample tubes contain potentially biohazardous material. Use caution when handling them so as to avoid breakage that may lead to injuries and contaminations.

-

Failing to mark a microvolume product or sample as such may lead to a needle damage and to the loss of the product or sample.

-

Carefully read the documentation provided with each product (reagents, controls, calibrators, diluents, Desorb solutions) and follow all the instructions.

Before identifying and loading a product or sample, wait for the completion of the previous loading (LED adjacent to the position on and beep sound). In case of product or sample loading cancellation, wait for 10 seconds before proceeding to another identification and loading.

3.3.1.2

Loading areas Sample Drawer (left-hand side drawer) and Product drawer (right-hand side drawer) form both loading areas. Sample Drawer: sample and diluents. Product drawer: controls, calibrators, reagents et Desorb solutions.

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3.3.1.3

Accessing the loading window

Test Panel screen Products " Click Products then Loading products.

Samples/diluents " Click Patient analyses then Loading samples.

OR " Click

.

OR " Click

.

 The message Drawer opening is displayed under the loading table.  The drawer is opening. NOTE: after a drawer opening request, if the analyzer is pipetting in the requested drawer or if the drawer is unavailable (especially the product drawer for incubation cuvettes), a message appears to indicate the opening request is logged.  The barcode reader switches on and beeps.  The loading window appears. RISK OF INJURY While a drawer is open, do not insert the hand or any other object inside the STA Compact Max®.

To inform the operator that the level detection management of a needle has been inhibited, a warning message is displayed when the requested drawer is opening (sample drawer, for needle #1, product drawer for the 3 needles). Sample drawer: all tubes should be decanted and the operator must ensure that plasma quantity is sufficient to perform the request assays. Product drawer: the theoretical volumes defined when the bottles were loaded must be consistent with the actual ones.

Concerning the product drawer, the STA Compact Max® will stop pipetting samples; it takes about 5 minutes to complete the pending analyses. A confirmation message is displayed as soon as the STA Compact Max® can release the selected drawer. The operator must then confirm the opening request. The message Drawer opening is displayed at the bottom of the Loading products window.

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3.3.2

Identifying and loading products Barcode identification and loading of products, see 3.3.2.1 Manual identification and loading of products, see 3.3.2.2 NOTE: the product loading described in this paragraph does not concern diluents. For the loading of diluents, see paragraph 3.3.3.

Expiration dates and lot numbers are not managed by the analyzer for the following products: - STA® OWREN KOLLER buffer (TOK), - STA® Desorb U solution, - STA® CaCl2 reagent, - STA® -CaCl2 0,01M, reagent, The operator must therefore check the expiration date of these products before loading them in the analyzer. For these products, stability and volume only are managed by the analyzer.

In case of lot number change, the calibrations related to these reagents will no longer be valid. When a stabilization period in the analyzer is required for some reagents, the methodologies using these reagents must be blocked before the loading. See the package inserts of each reagent kit and Block or resume methodologies, in 6.5.

Only the products used in the methodologies may be loaded onboard the analyzer.

3.3.2.1

Barcode identification and loading of products

In case of barcode reader failure; proceed to a manual loading of the product (see 3.3.2.2).

Loading products window (see B.2): cursor in the Identity field and message Please give product identification displayed " Scan the vial barcode label with the barcode reader.  The information concerning the product is displayed.  The cursor moves to the volume input field.

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" If necessary, correct the volume and stability . " If the product has been transferred into a microcup, select the Micro Volume option. " Press  to confirm the displayed information. " Place the vial in a position corresponding to its diameter. If the product requires stirring, place the vial in a stirring position. If the vial is not properly positioned, the operator is informed by an error message.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The product appears in the Product on board table.

The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

If a change of lot number is detected: For a reagent: " Validate the message informing that all the methodology calibrations using that product will become invalid. For a control: " Validate the message informing that all the controls will be blocked until the new threshold values are indicated. For a calibrator: " Validate the message informing that the new concentration must be indicated upon running the calibration. " In all cases, if the change of lot number is accepted, click Yes.  The Barcode reading window appears. " Scan the barcode sheet (Assay value insert) included in the box with the barcode reader. NOTE: In case of barcode reader failure, type the information printed below the barcodes and confirm each line with the  key.

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 For a pre-calibrated reagent, the following window appears: Barcode reading Operation complete Data read A0 xxx A1 xxx A2 xxx A3 xxx N xxx ISI xxx " Close the window.  The operation is complete. RISK OF INCORRECT RESULTS For all the related methodologies, the values of calibrators or control ranges will be properly dispatched provided the primary unit chosen for the methodology is identical to the primary unit used on the assay value insert (except: Fibrinogen).

3.3.2.2

Manual identification and loading of products

Manual identification can lead to typing errors. It is used under complete responsability of the user.

Loading products window (see B.2): cursor in the Identity field and message Please give product identification displayed. STA® line product " Type the product identification as defined in the methodology, then confirm by pressing  key.  The name, the volume and the stability of the product are automatically displayed.  The cursor moves to the volume input field. " If necessary, correct the volume and stability then confirm with the  key. " Type the lot number; then press  . " If the product has been transferred into a microcup, select the Micro Volume option.

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" Place the vial in a position corresponding to its diameter. If the product requires it, place the vial in a position requiring stirring. - If the vial is not properly positioned, the operator is informed by an error message. - The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The product appears in the Product on board table. " If a lot change is detected, follow the instructions described in paragraph If a change of lot number is detected: STA® line products " Type the identity, the name, the volume, the stability and the lot number of the product as defined in the methodology, using the  key to validate each entry.  A message appears concerning the stirring of the product. " If the reagent requires stirring, click Yes. If the reagent does not require stirring, click No. " If the product has been transferred into a microcup, select the Micro Volume option. " Place the vial in a position corresponding to its diameter. If the product requires it, place the vial in a position requiring stirring. - If the vial is not properly positioned, the operator is informed by an error message. - The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The product appears in the Product on board table. " If a lot change is detected, follow the instructions described in paragraph If a change of lot number is detected:

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3.3.3

Identifying and loading diluents (sample drawer) Barcode identification and loading of diluents, see 3.3.3.1 Diluent manual identification and loading, see 3.3.3.2

3.3.3.1

Barcode identification and loading of diluents

In case of barcode reader failure; proceed to a manual loading of the product (see 3.3.2.2).

Loading samples window (see B.3): cursor in the Identity field and message Please give sample (/diluent) identification displayed. " Scan the diluent barcode label with the barcode reader (e.g.Owren-Koller buffer).  The analyzer beeps and the Product detected window appears. Fig. 8 - Product detected window

" Select Diluent and click Confirm.

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 The window Diluent information appears. Fig. 9 - Diluent information window

 The product name is automatically displayed and shaded in the name input field.  The cursor moves to the volume input field. " If necessary, correct the volume and stability, using the  key to confirm the corrections. " If the product has been transferred into a microcup, select the Micro Volume option. " Click Confirm.  The window closes and the Patient analyses - Loading samples window reappears, cursor on the position input field. " If necessary, select or unselect the Micro volume option. " Load the vial in the reserved position (#8) or in any other position corresponding to its diameter. The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The diluent appears in the Samples table.

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3.3.3.2

Diluent manual identification and loading

Manual identification can lead to typing errors. It is used under complete responsability of the user.

Loading samples window (see B.3): cursor in the Identity field and message Please give sample (/diluent) identification displayed. STA® line product " Type the product identification as defined in the methodology, then confirm by pressing  key.  The Product detected window appears. " Select Diluent and click Confirm.  The window Diluent information appears.  The name, the volume and the stability of the product are automatically displayed.  The cursor moves to the volume input field. " If necessary, correct the volume and stability. " If the product has been transferred into a microcup, select the Micro Volume option. " Click Confirm.  The window closes and the Patient analyses - Loading samples window reappears. " Load the vial in the reserved position (#8) or in any other position corresponding to its diameter. The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The diluent appears in the Samples table. Non STA® line product " Type the identification as defined in the methodology, then confirm by pressing  key.  The Product detected window appears. " Select Diluent and click Confirm.  The window Diluent information appears. " Type the name, the volume and the stability of the product as defined in the methodology. " If the product has been transferred into a microcup, select the Micro Volume option. " Click Confirm.  The window closes and the Patient analyses - Loading samples window

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reappears. " Load the vial in the reserved position (#8) or in any other position corresponding to its diameter. The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the vial position lights up and the analyzer beeps.  The diluent appears in the Samples table.

3.3.4

General information on sample loading Sample type, see 3.3.4.1 Automatic mode, see 3.3.4.2 Manual mode, see 3.3.4.3 Selecting methodologies and defining methodology profiles, see 3.3.4.4

3.3.4.1

Sample type There are several sample categories: -

Normal samples: non urgent samples, loaded in standard tubes with a sufficient quantity of plasma for all the requested analyses

-

Urgent samples

-

Samples transferred into microcontainers

NOTE: an urgent sample may be loaded in a microcontainer. The sample nature must be indicated during the identification phase.

3.3.4.2

Automatic mode The Automatic mode is a fast sample loading mode allowing: -

to automatically apply a methodology profile (Automatic profile) to all the samples that must be loaded (see Creating a methodology profile)

-

to associate a First number to the first sample that must be loaded and to increment all the following ones (auto-incrementation).

Samples may also be applied a prefix which can serve to differentiate the different populations of samples according to criteria chosen by the laboratory. For example, POP for pre-operative, HEP for a patient treated with Heparin, AVK for a patient treated with anti-vitamin K.

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Loading samples window " To activate the automatic mode, click Automatic mode. " To define a prefix, click Change identity.  The Default identity window appears. Fig. 10 - Default identity window (automatic mode)

" Type the prefix then click Confirm. " To set an auto-incrementation, indicate a first number from the dialog box Default identity. " Click Confirm.

3.3.4.3

Manual mode The Manual mode is a loaging mode where the operator must select manually all the methodologies to apply to a sample during the loading. Methodologies may be selected individually or through a methodology profile (see 3.3.4.4). In Manual mode, the operator may also apply a Default identity to all the samples that must be loaded. The default identity can serve to differentiate the different populations of samples according to criteria chosen by the laboratory. For example, POP for pre-operative, HEP for a patient treated with Heparin, AVK for a patient treated with anti-vitamin K.

Loading samples window " Click Change identity.

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 The Default identity window appears. Fig. 11 - Default identity window (manual mode)

" Type the identity then click Confirm.

3.3.4.4

Selecting methodologies and defining methodology profiles Creating a methodology profile A methogology profile may include up to 6 methodologies. A maximum of 7 methodology profiles may be defined and modified at any time. A Patient file may be applied several profiles. A Patient file may include up to 12 methodologies.

Loading samples window (manual mode or automatic mode) (see B.3) " Click Change profiles.

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 The Modifying profiles window appears (see B.4). Fig. 12 - Modifying profiles window

" Place the cursor in the first empty line (after the last profile) and click Modify. " In the Methodologies area, double-click each methodology that must be added to the profile.  Each selected methodology is added to the methodology profile being created. " Click Confirm to validate the creation of the profile. In Automatic mode, only one methodology profile is used: the Automatic profile.

Loading samples window (manual mode or automatic mode) (see B.3) " Click Change profiles. " From the drop-down menu of the Automatic profile area, select the requested profile.  The selected profile is automatically applied to all the samples loaded in Automatic mode. NOTE: the profile By downloading may also be used as automatic profile. Adding methodologies to a profile

Modifying profiles window " Select the profile that needs to be modified then click Modify. " In the Methodologies area, double-click each methodology that must be added to the profile.

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 Each selected methodology is added to the methodology profile being created (lefthand side of screen). " Click Confirm to validate the modification of the profile. Deleting methodologies from a profile

Modifying profiles window " Select the profile that needs to be modified then click Modify. " In the Methodologies area, double-click each methodology that must be deleted from the profile. " Click Confirm to validate the modification of the profile. Deleting a methodology profile

Modifying profiles window " Select the profile that needs to be deleted then click Modify. " In the Methodologies area, double-click each methodology included in the profile.  The methodologies are deleted. " Click Confirm to validate the modification of the profile. Selecting a profile by downloading The profile By downloading allows the operator to request the list of methodologies from the Host computer. " From the Select methodologies window, double-click By downloading. " Click Confirm.  If the option Control patient data is defined as no, the data concerning the sample are transferred to the area of loaded samples (see 7.3.7).  If the option Control patient data is defined as yes, the following windows appear: DOWNLOADING IN PROGRESS... Please wait Abort DOWNLOADED INFORMATION File: * xxx Patient:** xxx xxx xxx xxx Confirm - Cancel *Patient file identification **Additional information (Name, first name...)

" If the data sent back by the Host Computer are correct, click Confirm.

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 The data are transferred. " If the data sent back by the Host Computer are not correct, click Cancel.  The following window appears: Loading samples DOWNLOADING Please ensure that the tube has been removed from position xxx CONFIRM  The LED near the tube blinks. " Remove the tube then confirm. Recalling the list of methodologies The automatic recalling of the list of methodologies is only possible for Patient files already known by the STA Compact Max® because they have been already loaded, processed removed but not deleted. Once reloaded, the tubes are automatically recognized by the analyzer which automatically applies the same methodologies that were requested the first time they were loaded. The methodology list automatically appears.

Loading samples window (manual mode or automatic mode) (see B.3) " Identify and load the sample (see 3.3.5).  The sample data are automatically transferred.

3.3.5

Identifying and loading samples Barcode identification and loading of samples, see 3.3.5.1 Manual identification and loading of samples, see 3.3.5.2

3.3.5.1

Barcode identification and loading of samples

Loading samples window (see B.3) " Depending on the required mode, click Manual mode or Automatic mode (see 3.3.4.2 or 3.3.4.3). " Scan the sample tube label with the barcode reader.  The tube identity is displayed. " If necessary, select or unselect the options and Urgent to specify the sample nature.

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" If the Manual mode is activated, proceed to the selection of methodologies. Fig. 13 - Select methodologies window

For an individual selection: " Double-click each methodology then click Confirm. For a selection by methodology profile (see 3.3.4.4) : " From the Select methodologies window, select a methodology profile then click Confirm. NOTE: In Automatic mode, the Automatic profile is automatically applied. " Place the sample tube in the sample drawer The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the tube position lights up.  The sample appears in the Samples table.

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3.3.5.2

Manual identification and loading of samples

Manual identification can lead to typing errors. It is used under complete responsability of the user.

Loading samples window (see B.3) " Depending on the required mode, click Manual mode or Automatic mode (see 3.3.4.2 or see 3.3.4.3) " Type the sample identification, then confirm with the  key. " If necessary, select or unselect options Micro Volume and Urgent to specify the sample nature. " If the Manual mode is activated, proceed to the selection of methodologies. Fig. 14 - Select methodologies window

For an individual selection: " Double-click each methodology then click Confirm. For a selection by methodology profile (see 3.3.4.4) : " From the Select methodologies window, select a methodology profile then click Confirm. NOTE: In Automatic mode, the Automatic profile is automatically applied.

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" Place the sample tube in the sample drawer. The loading is automatically canceled if, after 10 seconds, the operation is not confirmed.

 The LED adjacent to the tube position lights up.  The sample appears in the Samples table.

3.3.6

Modifying loaded products or samples Modifying products onboard, see 3.3.6.1 Modification procedure for the sample drawer, see 3.3.6.2

3.3.6.1

Modifying products onboard This procedure is only possible for products that have just been loaded (current loading session). For products, the possible modifications concern: -

the volume

-

the stability

-

the volume indication (normal / Micro volume)

Loading products windows (see B.2) " Right-click the requested product.  A pop-up menu appears. " Click Modify.  The product reappears in the Loading a product (see B.2). " Modify the information that must be modified and click Confirm.

3.3.6.2

Modification procedure for the sample drawer This procedure is only possible for samples or diluents that have just been loaded (current loading session). For samples the possible modifications concern: -

the list of methodologies on Manual Mode

-

the Micro Volume option

-

the Urgent tube option

For diluents, the possible modifications concern:

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the volume

-

the stability

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-

the Micro Volume option

Loading samples window (see B.3) " Right-click the requested sample.  A pop-up menu appears. " Click Modify.  The product reappears in the Loading a sample (see B.3). " Modify the information that must be modified and click Confirm. NOTE: In Manual mode, click in the Methodologies requested to modify the methodologies from the the Select methodologies window (see 3.3.4.4).

3.3.7

Unloading samples or products This procedure is only possible for samples or products (reagents, controls, calibrators, Desorb solutions or diluents) loaded with positive identification; i.e.: automatic identification of the position. The LEDs adjacent to tubes and vials start blinking: -

for samples which related Patient files are complete,

-

for products with stability overdue and/or insufficient volume.

Loading products windows (see B.2) OR Loading samples window (see B.3) " Remove the tube (or vial).  The LED adjacent to the tube or vial lights off.  The tube or vial identity disappears from the list of onboard samples or products.

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Table of contents

4

Routine use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

4.1

analysis status and product status . . . . . . . . . . . . . . . . . . . . .

1

4.1.1 Analysis status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

4.1.2 Product status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

4.2

2

Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2.1 General information about calibrations . . . . . . . . . . . . . . . . . . . . . . . .

2

4.2.2 Loading calibrators and calibration controls . . . . . . . . . . . . . . . . . . . . .

4

4.2.3 Running and validating calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

4.2.3.1 Running and validating a barcode mode calibration . . . . . . . . . . . . . . . . . . . . . . . . . .

5

4.2.3.2 Running and validating a raw mode calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

4.2.3.3 Running and validating a ratio mode calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

4.2.3.4 Running and validating a graphic mode calibration . . . . . . . . . . . . . . . . . . . . . . . . . .

8

4.2.3.5 Running several calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

4.2.4 Procedures to observe in case the calibration is not automatically confirmed 10 4.2.4.1 Confirming out of range calibration controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

4.2.4.2 Rerunning Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

4.2.4.3 Validating a calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

4.2.4.4 Restoring the previous calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

4.2.4.5 Rerunning a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

4.2.4.6 Cancelling a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

4.2.5 Other possible interventions on confirmed calibrations . . . . . . . . . . . .

16

4.2.5.1 Correcting the 100% Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

4.2.5.2 Correcting the offset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

4.2.5.3 Modifying measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

4.2.5.4 Correcting calibration points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

4.2.5.5 Printing the calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

4.2.5.6 Modifying the ISI value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

4.2.5.7 Viewing the Information screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

4.3

21

Quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.3.1 General information about quality controls . . . . . . . . . . . . . . . . . . . . .

21

4.3.2 Running and validating quality controls . . . . . . . . . . . . . . . . . . . . . . . .

23

4.3.2.1 General Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

4.3.2.2 Loading Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

4.3.2.3 Changing the threshold values for quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

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Table of contents

4.3.2.4 Running a quality control level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26

4.3.2.5 Simplified Running for Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

4.3.3 Procedures to observe for out of range Quality Controls . . . . . . . . . . .

27

4.3.3.1 Alarm codes and alarm message displayed for out of range quality controls . . . . . . .

27

4.3.3.2 Description of the Quality control out of range window . . . . . . . . . . . . . . . . . . . . . . . .

28

4.3.3.3 Accepting out of range Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

4.3.3.4 Rerunning out of Range Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

4.3.4 Other available operations on Quality Controls . . . . . . . . . . . . . . . . . .

29

4.3.4.1 Cancelling a quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

4.3.4.2 Deleting controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

4.3.4.3 Deleting all results of Quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

4.3.4.4 Printing Quality Control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

4.3.4.5 Transmitting today’s Quality Control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

4.4

Running analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

4.5

Switching the analyzer off . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

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4

Routine use Analysis status and product status, see 4.1 Calibrations, see 4.2 Quality controls, see 4.3 Running analyses, see 4.4 Switching the analyzer off, see 4.5

4.1

Analysis status and product status Analysis status, see 4.1.1 Product status, see 4.1.2

4.1.1

Analysis status Analysis status window (see description in B.5) displays a consistency check between the workload of the STA Compact Max® (number of analyses to perform except for blocked analyses) and the requirements for the completion of this task: -

products (cuvettes, washing solution, controls, calibrators, diluents, reagents),

-

validated calibrations,

-

and validated quality controls.

It is displayed: -

upon request from the Products menu,

-

after closing the sample and product drawers,

-

after adding an analysis in a Patient report format (see 6.3),

-

after rerunning an analysis (see 6.4),

-

after running a calibration (see 4.2),

-

after running a quality control (see 4.3).

If after the consistency check, one of the requirements to complete the workload is not met, then all the sample pipetting (sample plasma, controls and calibrators) are blocked and the Pipetting blocked symbol is displayed at the foot of the screen:

In that case, the operator can reactivate the sample pipetting for the analyses meeting all the conditions (correct calibration, quality control, volume and stability for all requested products) by clicking Yes when the following message is displayed: Analyses executions have been stopped. Do you want to reactivate them? NOTE: this screen is updated every 5 minutes.

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4.1.2

Product status The Product status screen provides information concerning cuvettes and products onboard (reagents, diluents, desorb solutions, controls or calibrators). For a description of the screen, Screen Product status in B.6.

4.2

Calibrations General information about calibrations, see 4.2.1 Loading calibrators and calibration controls, see 4.2.2 Running and validating calibrations, see 4.2.3 Procedures to observe in case the calibration is not automatically confirmed, see 4.2.4 Other possible interventions on confirmed calibrations, see 4.2.5

4.2.1

General information about calibrations Accessing a calibration " From the Test Panel, click Calibration menu or click

.

 The Calibration screen appears with the cursor positioned on the first methodology of the list (see B.8.1). " Double-click the requested methodology.  The selected calibration screen is displayed (see B.8.2 to B.8.5). Meaning of color symbols associated to calibrations

Valid calibration Calibration to be validated Calibration in process Calibration not done

Running calibrations Calibrations can be run: -

One by one from the Calibration - Methodologies list screen: " Double-click the requested methodology (see B.8.1).

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-

Globally (several methodologies at a time), from the Calibration - Methodologies list screen: " Select the boxes on the left side of the methodologies that must be calibrated then click (see B.8.1). Running calibrations when sample pipettings have been blocked is not recommended.

Calibrations may be run according to 7 methods: Method

Calibrate

Barcoded Only for some Diagnostica Stago methodologies

The two levels of calibration controls must be run. Parameters are read during the loading of the reagent (see 3.3.2)

Raw

Run the two calibration controls if they have been defined in the Methodologies menu screens.

Ratio

Type the Reference Time value. Run the two calibration controls if they have been defined in the Methodologies menu screens.

Linear graphic

Run the calibrators.

Polynomial order 2 graphic

Click the calibration button to run the two calibration controls if they have been defined in the Methodologies menu screens.

Polynomial order 3 graphic Hyperbolic graphic

Use of calibration controls authorizes automatic validation of the calibrations. Two levels of calibration controls must be used. Only one level is not enough to validate the slope reliably.

Calibration methods as well as all calibration parameters (definition of calibrators, calibration control, scales...) can be defined in the Methodologies menu screens (see chapter 5 and see B.10).

Calibrators are run in single or duplicate mode depending on the determination mode chosen for the calibration (see 5.8.7). When they have been defined, calibration controls are run either in single or duplicate mode depending on the determination mode chosen for the sample (see 5.7.7).

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As soon as calibration control results are given, they are compared to the acceptance range; if they are outside the acceptance range, the analyzer automatically reruns controls according to the principle described below:

First run

Result(s)

Automatic rerun

Control run in single

Outside the defined range

The control is rerun in duplicate

Control run in duplicate

1 of the 2 results is outside the defined range

The control is rerun in single

If the calibration control(s) are confirmed as outside the acceptance range, the calibration must be validated manually. If the operator decides to accept out of range calibration controls, the results of these are displayed in red, preceded by an asterisk in the related calibration screen.

If the same controls are used as calibration controls and quality controls (same identification numbers), the calibration control results are integrated in the quality control cumulative totals. The clock for the quality controls is reset when calibration controls are run.

When the Calibration - Methodologies list screen is closed after the running of one or several calibrations or quality controls, the analyzer performs a consistency check and then displays the Analysis status screen. If the products required for the calibrations are not onboard or if they have stability overdue or insufficient volume, the calibration is not run. Missing products are displayed in red in the Analysis status screen and sample pipettings are blocked.

4.2.2

Loading calibrators and calibration controls Calibrators and calibration controls are loaded in the product drawer (see 3.3.2). For each change of lot number, the concentrations of calibrators and/or the calibration control thresholds for STA® line products from Diagnostica Stago are scanned by means of the assay value inserts included with each product box. For all other products, the values have to be typed manually.

RISK OF INCORRECT RESULTS For STA® line products from Diagnostica Stago, calibrator values and calibration control threshold values are properly dispatched in the related methodologies provided the primary unit chosen for this methodology is identical to the one defined in the package inserts included in each product box (except Fibrinogen, for g/l primary unit, the values are properly dispatched even if they are given in mg/dl in the package insert).

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4.2.3

Running and validating calibrations Running and validating a barcode mode calibration, see 4.2.3.1 Running and validating a raw mode calibration, see 4.2.3.2 Running and validating a ratio mode calibration, see 4.2.3.3 Running and validating a graphic mode calibration, see 4.2.3.4 Running several calibrations, see 4.2.3.5

4.2.3.1

Running and validating a barcode mode calibration For each change of lot number, the parameters of the calibration curve are scanned when the requested reagent is loaded onboard. The calibration must be validated by 2 calibration controls which ensure that the analyzer has not drifted from reference analyzers. When closing the product drawer, if the calibration controls are already onboard, the calibration status for the requested methodology changes to "in progress" in the Analysis status screen . The calibration controls are automatically run by the analyzer if the sample pipettings have not been blocked by the operator. Otherwise, the calibration controls are automatically run as soon as they are loaded and provided the operator has not blocked the sample pipettings. If both calibration control results are within the expected ranges, the calibration is automatically validated and patient analyses may start. Both calibration results are displayed in the graphic area of the calibrated methodology (see B.8.2). If the results of one or several calibration control are outside the expected ranges, the operator is informed by an error message. At any time, the operator can run calibration controls on his own request, see below.

Pre-calibrated calibration screen (see B.8.2) " Click Run controls.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Start running window for the selected calibration is displayed. The cursor is positioned on the minimum threshold of the first calibration control. " Correct, if necessary the control thresholds, pressing the  key after each correction. " When all thresholds are correct, click Confirm.  The Start running window of the calibration reappears.  The calibration controls are automatically run by the analyzer provided the consistency check does not lead to a blocking of the sample pipetting. " Click

.

 The Calibration - Methodologies list screen reappears.  A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

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 If the calibration control results are within the expected ranges: - the calibration is automatically validated, - a green triangle is displayed on the right of the validated methodology (valid calibration

) when the Calibration - Methodologies list is displayed.

 If the calibration control results are outside the expected ranges, an error message is displayed (calibration to be validated

4.2.3.2

).

Running and validating a raw mode calibration There are no calibrations in raw mode: the only possible operation is to validate the reagent(s) of the methodology, during a change of lot number, by running the 2 calibration controls if they have been defined. If both calibration control results are within the expected ranges, the calibration is automatically validated, patient analyses may start. If the results of calibration controls are outside the expected ranges, the operator is informed by an error message. If the calibration controls are not used, the calibration status is automatically validated.

Raw mode calibration screen (see B.8.3) " Click Run controls.  A window requesting the access code appears. " Type the access code and then click Confirm.  The cursor is positioned on the minimum threshold of the first calibration control. " Correct, if necessary the control thresholds, pressing the  key after each correction. " When all thresholds are correct, click Confirm.  The calibration controls are automatically run by the analyzer provided the consistency check does not lead to a blocking of the sample pipetting. " Click

.

 The Calibration - Methodologies list screen reappears.  A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

 If the calibration control results are within the expected ranges: - the calibration is automatically validated, - a green triangle is displayed on the right of the validated methodology (valid calibration

) when the Calibration - Methodologies list is displayed.

 If the calibration control results are outside the expected ranges, an error message is displayed (calibration to be validated

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4.2.3.3

Running and validating a ratio mode calibration For a ratio mode, calibrations consist in typing the reference time, then running the 2 calibration controls if they have been defined to validate the reagent(s) used for the methodology. If both calibration control results are within the expected ranges, the calibration is automatically validated, patient analyses may start. If the results of calibration controls are outside the expected ranges, the operator is informed by an error message. Running and validating calibrations in ratio mode with calibration controls

Ratio mode calibration screen (see B.8.4) " Click Run controls.  A window requesting the access code appears. " Type the access code and then click Confirm.  The cursor is positioned in the Reference Time field to modify it if necessary. " Modify if necessary the value of the reference time, then confirm with the  key.  The cursor is positioned on the minimum threshold of the first calibration control. " Correct, if necessary the control thresholds, pressing the  key after each correction.  If INR unit has been chosen among the secondary units, the cursor is positioned to modify the ISI value if necessary. " Modify if necessary the ISI value, then confirm with the  key. " When all the modifications have been made, click Confirm.  The calibration controls are automatically run by the analyzer provided the consistency check does not lead to a blocking of the sample pipetting. " Click

.

 The Calibration - Methodologies list screen reappears.  A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

 If the calibration control results are within the expected ranges: - the calibration is automatically validated, - A green triangle is displayed on the right of the validated methodology (valid calibration

) when the Calibration - Methodologies list is displayed.

" If the calibration control results are outside the expected ranges, an error message is displayed (calibration to be validated

).

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Running and validating calibrations in ratio mode without calibration controls

Ratio mode calibration screen (see B.8.4) " Click Confirm.  A window requesting the access code appears. " Type the access code and then click Confirm.  The cursor is positioned in the Reference Time field to modify it if necessary. " Modify if necessary the value of the reference time, then confirm with the  key.  If INR unit has been chosen among the secondary units, the cursor is positioned to modify the ISI value if necessary. " Modify if necessary the ISI value, then confirm with the  key.  ISI value is displayed. " When all the modifications have been made, click Confirm.  The Calibration - Methodologies list screen reappears.  A green triangle is displayed on the right of the selected methodology (valid calibration

4.2.3.4

).

Running and validating a graphic mode calibration For a graphic mode, calibration consists in running calibrators, then calibration controls if they have been defined. If both calibration control results are within the expected ranges, the calibration is automatically validated, patient analyses may start. If the results of calibration controls are outside the expected ranges, the operator is informed by an error message. If calibration controls are not used, the calibration has to be validated manually (see 4.2.4). Running and validating calibrations in graphic mode with calibration controls

Graphic mode calibration screen (see B.8.5) " Click Calibrate.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Start running calibration window appears, displaying the Calibrators tab.  The cursor is positioned on the field Concentration for the first calibrator. " Correct, if necessary the concentrations of the calibrators, pressing the  key after each correction. " From the Products tab correct if necessary the control thresholds, pressing the  key after each correction. " When all the modifications have been made, click Confirm.  The requested calibration window reappears.

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" Click

to return to the Calibration - Methodologies list screen.

" A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

 If the calibration control results are within the expected ranges: - the calibration is automatically validated, - a green triangle is displayed on the right of the validated methodology (valid calibration

) when the Calibration - Methodologies list is displayed.

 If the calibration control results are outside the expected ranges, an error message is displayed (calibration to be validated

).

Running and validating calibrations in graphic mode with calibration controls

Graphic mode calibration screen (see B.8.5) " Click Calibrate.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Start running calibration window appears, displaying the Calibrators tab.  The cursor is positioned on the field Concentration for the first calibrator. " Correct, if necessary the concentrations of the calibrators, pressing the  key after each correction. " When all the modifications have been made, click Confirm.  The requested calibration window reappears. " Click

to return to the Calibration - Methodologies list screen.

" A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

 When the calibration is done, an information message appears and the calibration has to be validated due to the absence of controls (calibration to be validated

4.2.3.5

).

Running several calibrations This function is only for predefined Diagnostica Stago methodologies because it implies that no operator intervention is requested to modify calibrator concentrations and/or calibration control concentrations. This is only possible for barcoded products (calibrators, controls) which values are automatically transferred. Calibration running requests are refused in the following conditions: -

raw mode without calibration controls,

-

ratio mode without calibration controls or with undefined reference time,

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-

calibration status: "in progress" (

) or "to be validated" (

).

NOTE: several calibrations may be run from each methodology calibration.

The Calibration - Methodologies list screen (see B.8.1) " Select all the boxes of the methodologies requiring a calibration.

" Click

.

 A window requesting the access code appears. " Type the access code and then click Confirm. " A yellow triangle is displayed on the right of the selected methodology (calibration in progress

) and the following message is displayed at the bottom of the screen:

All calibrations and calibration controls will start on return to the screen "PRODUCTS Analysis status". " Click

.

" The calibrators and the calibration controls (if necessary) are automatically run by the the analyzer provided the consistency check does not lead to a blocking of the sample pipettings. " The Analysis status window appears (see B.5). " If the calibration control results are within the expected ranges: - the calibration is automatically validated, - a green triangle is displayed on the right of the validated methodology (valid calibration ) when the Calibration - Methodologies list is displayed. " If the calibration control results are outside the expected ranges, an error message is displayed (calibration to be validated

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4.2.4

Procedures to observe in case the calibration is not automatically confirmed Confirming out of range calibration controls, see 4.2.4.1 Rerunning Controls, see 4.2.4.2 Validating a calibration curve, see 4.2.4.3 Restoring the previous calibration, see 4.2.4.4 Rerunning a calibration, see 4.2.4.5 Cancelling a calibration, see 4.2.4.6 There can be two possible cases: -

The calibration is not validated due to out of range calibration controls.

-

The calibration is not validated due to the absence of calibration controls.

For calibrations in graphic mode, as long as the reagent lot number has not been changed, the new calibration is displayed in blue and the previous one in gray. The measurements, the equation and the regression coefficient are those of the new calibration curve. Messages displayed in case the calibration is not automatically validated:

Calibration controls out of range

Absence of controls

Measurement management Error 10.03.14

Measurement management Error 10.03.51

Calibration control

Calibration

Control is out of range

calibration needs confirming

for the xxx

for the xxx

Continue

Continue xxx: abbreviation of the methodology

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Description of the Invalid calibration - Controls out of range window Fig. 1 - Representation of the Invalid calibration - Controls out of range window

INVALID CALIBRATION Controls out of range Identity (1)

Results (2)

Min Threshold

Max Threshold (3)

xxxxxx

xx

xx

x

xx

xxx

xxxxxx

xx

xx

x

xx

xxx

Confirm calibration Rerun Controls Restore previous calibration

Rerun calibration Cancel calibration

(4)

Postpone decision

Legend: 1. Calibration control identification numbers 2. Calibration control results with recall of the primary unit. Out of range results are displayed in red. 3. Recall of the minimum and maximum thresholds for each calibration control 4. Available functions: - Confirm calibration: allows to validate out of range controls (see 4.2.4.3) - Rerun control: allows calibration controls to be rerun (see 4.2.4.2) - Restore previous calibration: allows to return to the previous calibration if no change of lot number was made (see 4.2.4.4) - Rerun calibration: allows to rerun the calibration (see 4.2.4.5) - Cancel calibration: allows to cancel the calibration in case of lot number change (see 4.2.4.6) - Postpone decision: allows to return to the Calibration - Methodologies list window.

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Description of the Invalid calibration - No controls window Fig. 2 - Representation of the Invalid calibration - no controls window

INVALID CALIBRATION No controls Confirm calibration (1)

Rerun calibration (4)

Correct points (2)

Cancel calibration (5)

Restore previous calibration (3)

Postpone decision (6)

Legend: 1. Confirm calibration: allows to manually validate a calibration (see 4.2.4.1) 2. Correct points: allows to modify calibration points and then to manually validate the calibration (see 4.2.5.3) 3. Restore previous calibration: allows to return to the previous calibration if no change of lot number was made (see 4.2.4.4) 4. Rerun calibration: allows to rerun the calibration (see 4.2.4.5) 5. Cancel calibration: allows to cancel the calibration in case of lot number change (see 4.2.4.6) 6. Postpone decision: allows to return to the Calibration - Methodologies list window.

4.2.4.1

Confirming out of range calibration controls This procedure is only possible if the operator knows the access code to accept out of range controls (see 7.3.4). If for a selected methodology, the calibration controls are confirmed though out of range, then the results of these controls are displayed in red in the related calibration screen and an alarm is associated to the analysis results. In the Invalid calibration - Controls out of Range window, out of range controls are displayed in red and the ranges of each control are recalled (see figure 1).

The selected calibration screen is displayed with the Invalid calibration - Controls out of range window, cursor is positioned on Confirm calibration (see figure 1) " Click Confirm calibration.  A window requesting the access code appears. " Type the access code and then click Confirm.  The selected calibration screen is updated for the date, the time and the calibration control results.  Out of range calibration control results are displayed in red with an asterisk. " Click

.

 The Calibration - Methodologies list screen reappears. " A green triangle is displayed on the right of the selected methodology (valid calibration ).

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4.2.4.2

Rerunning Controls This function is possible only if calibration controls have been defined.

The selected calibration screen is displayed with the Invalid calibration - Controls out of range window, cursor positioned on Confirm calibration (see figure 1) " Reload the products if necessary (reagents, calibrators, diluents, controls). " Click Rerun Controls.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Calibration Controls in progress window appears.  Controls are rerun by the analyzer provided the consistency check does not lead to a blocking of the sample pipettings. " Click

.

 The Calibration - Methodologies list screen reappears. " A yellow triangle is displayed on the right of the selected methodology (calibration in progress

4.2.4.3

).

Validating a calibration curve This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4).

The selected calibration screen is displayed with the Invalid calibration - No controls window, cursor positioned on Confirm calibration (see figure 2) " Click Confirm calibration.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Invalid calibration window disappears. " Click

.

 The Calibration - Methodologies list screen reappears.  A green triangle is displayed on the right of the selected methodology (valid calibration

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4.2.4.4

Restoring the previous calibration This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). This procedure is only possible for calibration curves performed with the same reagent lot numbers as previously used.

The selected calibration screen is displayed with the Invalid calibration - Controls out of range window, cursor positioned on Confirm calibration (see figure 1 and 2) " Click Restore previous calibration.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Invalid calibration window disappears.  The screen of the selected calibration is displayed again with the previous calibration curve and all associated parameters (equation, regression coefficient, measured values, interpolated concentrations and control values if they were parametered).

4.2.4.5

Rerunning a calibration This option is not available for barcoded calibrations.

The selected calibration screen is displayed with the Invalid calibration - Controls out of range window or Invalid calibration - No controls window (see figure 1 and 2) " Reload the products if necessary (reagents, calibrators, diluents, controls). " Click Rerun calibration.  A window requesting the access code appears. " Type the access code and then click Confirm.  The Calibrating in progress window appears.  The calibrators (and the calibration controls if they are used) are rerun by the analyzer provided the consistency check does not lead to a blocking of the sample pipettings.

" Click

.

 The Calibration - Methodologies list screen reappears.  A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

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4.2.4.6

Cancelling a calibration Cancelling an unvalidated calibration This option is only available if the calibration has been run with new reagent lot numbers.

The selected calibration screen is displayed with the Invalid calibration - Controls out of range window or Invalid calibration - No controls window and cursor positioned on Confirm (see figure 1 and 2) " Click Cancel calibration.  The Invalid calibration window disappears.  The calibration curve disappears.  A red triangle is displayed on the right of the selected methodology (calibration not done

).

Cancelling a calibration request

RISK OF INCORRECT RESULTS Do not cancel a calibration once it has been requested. In case of calibration cancellation, controls must be calibrated again and/or rerun, the exactitude of the ISI value must be checked and calibration cancellations must be stopped.

Running of a calibration confirmed " Click Abort.  The following message appears: CANCEL CALIBRATION Do you want to cancel the calibration in progress and recall the previous calibration? Yes

No

" Click Yes. The calibration is affected the following way:  The values displayed in the Informations screen correspond to the last typed threshold values (typed or scanned with the barcode reader during the lot change).  The calibration keeps the same status as before running the calibration.

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4.2.5

Other possible interventions on confirmed calibrations Correcting the 100% Point, see 4.2.5.1 Correcting the offset, see 4.2.5.2 Modifying measures, see 4.2.5.3 Correcting calibration points, see 4.2.5.4 Printing the calibration, see 4.2.5.5 Modifying the ISI value, see 4.2.5.6 Viewing the Information screen, see 4.2.5.7

4.2.5.1

Correcting the 100% Point This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). This option is only possible for clotting analyses with % as primary unit and if the measurement scale is linear and the concentration scale is inverse. It moves the calibration curve in a parallel direction to itself in such a way that the calibration passes through the new point given in seconds and which corresponds to the 100%.

A calibration screen " Click Modify parameters.  A window requesting the access code appears. " Type the access code and then click Confirm.  The cursor moves to the modification field of: - the ISI value if INR has been chosen as other unit, - the 100% point. " Click Corr. point 100% on the left of the input field then click in the input field. " Type the time in seconds that corresponds to the 100% point then click Confirm.  The screen of the selected calibration is displayed with the previous calibration curve displayed in gray stipples and the new curve in blue.  In the curve equation, the slope is kept and the Y intercept is recalculated.  The interpolated concentrations are recalculated or in case of pre-calibrated calibration, the values in the Measurements column are modified.  If calibration controls are defined, they are automatically run by the analyzer provided the consistency check does not lead to a blocking of the sample pipettings. " Click

.

 The Calibration - Methodologies list screen reappears.  If calibration controls have been defined a yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

 If calibration controls have not been defined a green triangle is displayed on the right of the selected methodology (valid calibration

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4.2.5.2

Correcting the offset This function is only possible for photometric (chromogenic or immunological) analyses with linear graphic mode for which the offset corrector and the calibration controls have been defined. It moves the calibration curve in parallel direction to itself in such a way that it passes through the new points defined by the offset corrector plasma.

Photometry analysis calibration screen " Click Correct offset.  A window requesting the access code appears. " Type the access code and then click Confirm. " Modify if necessary the concentration of the offset corrector plasma then confirm with the  key. " Modify if necessary each threshold value, then confirm with the  key. " When all parameters are correct, click Confirm.  The requested calibration window reappears.

" Click

.

 The Calibration - Methodologies list screen reappears.  A yellow triangle is displayed on the right of the selected methodology (calibration in progress

).

After confirmation of the calibration:

4.2.5.3

-

the new calibration curve is displayed in blue,

-

the previous curve is displayed in gray stipples,

-

the interpolated concentrations are recalculated,

-

the reading corresponding to the offset corrector plasma is displayed near Offset correction (see B.10.3).

Modifying measures This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). This procedure is only possible for non pre-calibrated calibrations in graphic mode. In case of absence of controls, follow the procedure described in 4.2.4.3 to correct the points and then validate the calibration.

Graphic mode calibration screen OR Invalid calibration - no controls window " Click Correct points.

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 A window requesting the access code appears. " Type the access code and then click Confirm. " To delete values: move the cursor to the value(s) that must be deleted, then click Delete from the contextual menu. Depending on the regression type, a minimum number of calibration points should remain: - 2 for linear regression, - 4 for order 2 polynomial regression, - 5 for hyperbolic regression, - 6 for order 3 polynomial regression, Otherwise, the curve disappears. A value may be restored from the contextual menu.

 A red D is displayed next to the deleted value.  The deleted value is displayed in gray. NOTE: erroneous values cannot be modified or deleted. " To modify values: move the cursor to the value that must be modified. Type the new value and confirm with the  key.  The modified value is displayed. " When all the modifications have been made, click Confirm.  The new calibration is recalculated then the following pieces of information are displayed: - the new calibration curve, - the new equation, - and the new regression coefficient.  A red D is displayed next to the deleted value and a black M next to the modified value.  The deleted value is still displayed in gray.

" Click

.

 The Calibration - Methodologies list screen reappears.  If calibration controls are defined, they are automatically run by the analyzer provided the consistency check does not lead to a blocking of sample pipettings.

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4.2.5.4

Correcting calibration points This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). This procedure is only possible if calibration controls are not used.

Selected calibration screen displayed with the Invalid calibration - No controls window (see figure 2) " Click Correct points. " To delete values, right-click the value that must be deleted and, from the contextual menu, click Delete.  A red D is displayed next to the deleted value.  The deleted value is displayed in gray.

Depending on the regression type, a minimum number of calibration points should remain: - 2 for linear regression, - 4 for order 2 polynomial regression, - 5 for hyperbolic regression, - and 6 for order 3 polynomial regression.

" To restore a value, right-click the value that must be restored and, from the contextual menu, click Restore. " To modify values, move the cursor to the value(s) that must be modified then proceed with the modification and confirm with the  key. " When all the modifications have been made, click Confirm.  The new calibration is recalculated then the following pieces of information are displayed: - the new calibration curve, - the new equation - and the new regression coefficient.  A red D is displayed next to the deleted value(s) and a black M next to the modified values.  Deleted values are displayed in gray.

" Click

.

 The Calibration - Methodologies list screen reappears.  A green triangle is displayed on the right of the selected methodology (valid calibration

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4.2.5.5

Printing the calibration This operation is possible only if no measurement is in progress and if all printouts previously requested have been performed.

A calibration screen " Click

.

 The following window appears: Fig. 3 - Printout window

 Depending on the calibration mode, one or two calibration screens are printed.  Each out of range calibration control result is printed with an asterisk.

4.2.5.6

Modifying the ISI value This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). The ISI value for the Prothrombin must be the value indicated on the insert included in the STA® line product. The operator must check the ISI value before leaving the menu if there has been a lot change, a software update, or any other major change. An incorrect ISI value can lead to inaccurate INR (International Normalization Ratio) results.

The ISI (International Sensitivity Index) value can be modified in various ways depending on the selected calibration mode: -

For ratio modes, it can be modified when accessing the Run controls function (see B.8.4).

-

For pre-calibrated and graphic modes, it can be modified the following way:

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A calibration screen " Click Modify parameters.  A window requesting the access code appears. " Type the access code and then click Confirm. " Type the new ISI coefficient value and then click Confirm.  The new ISI value is displayed near ISI.

4.2.5.7

Viewing the Information screen This function is available only when there are 2 screens to define a calibration: -

pre-calibrated calibration mode or

-

graphic calibration mode (linear, hyperbolic, polynomial order 2 or 3).

A calibration screen

" Click

.

 The Informations screen appears (see B.8.2).

4.3

Quality controls General information about quality controls, see 4.3.1 Running and validating quality controls, see 4.3.2 Procedures to observe for out of range Quality Controls, see 4.3.3 Other available operations on Quality Controls, see 4.3.4

4.3.1

General information about quality controls Accessing a quality control

" From the Test Panel, click Quality Controls menu or click

.

 The window Quality controls - Methodologies list appears. " Double-click the requested methodology.  The quality control results for the first control are displayed in graphic format (see B.9.2).

NOTE: click

to display results in table format.

" Click Next level to display the next level results if they have been defined. " Click

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 The window Quality controls - Methodologies list reappears. Meaning of the color code associated to quality controls

Valid quality control Quality control to be validated Quality control in process Quality control not done

For each methodology, at least one quality control has to be run daily if at least one patient result is requested for this methodology. RISK OF INCORRECT RESULTS If the results of a quality control are out of range, the validity of all the results since the last correct quality control should be questioned.

Up to 3 quality controls can be defined for each methodology from the methodology screens (see chapter 5 ). Quality controls are loaded in the product drawer and are automatically run by the analyzer (see 4.3.2). In the window Quality Control - Graphic (or Quality Control - Tables), the quality control results are treated in 3 areas (see B.9): -

controls for today,

-

daily cumulative totals,

-

monthly cumulative totals.

Up to 2 lot numbers may be managed in these areas. When controls from a new lot are loaded, the values of the oldest lot are automatically deleted. The previous lot becomes the old lot and the new lot becomes the current lot. The treatment of the quality controls is based on the Levey-Jennings statistical model: Mean:

i=n

∑ xi i=1 m = ------------n

xi = result in the primary unit

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Standard deviation:

Coefficient of variation in %:

n varies depending on the 3 treatment areas: Area

4.3.2

n

Controls for today

1 to 24

Daily cumulative totals

1 to 31

Monthly cumulative totals

1 to 12

Running and validating quality controls General Principles, see 4.3.2.1 Loading Quality Controls, see 4.3.2.2 Changing the threshold values for quality controls, see 4.3.2.3 Running a quality control level, see 4.3.2.4 Simplified Running for Quality Controls, see 4.3.2.5

4.3.2.1

General Principles The quality controls for a methodology are automatically run when the STA Compact Max® has to perform an analysis using that methodology and when the time since the last control exceeds the period defined in the Methodologies screens (see 5.3). That period cannot exceed 24 hours. Quality controls can also be run on operator’s request from these 2 screens:

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-

Window Quality controls - Methodologies list. In this case, all quality control levels for the selected methodologies are run (simplified running, see 4.3.2.5)

-

Screen of quality control results for a selected level. In this case, only the selected level is run.

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Running calibrations when sample pipettings have been blocked is not recommended.

Blocking methodologies by means of the Block/Resume methodologies menu blocks the automatic running of quality controls (periodic) but does not block the running of quality controls requested by the operator (see 6.5). Quality controls are run in single or in duplicate depending on the determination chosen for the sample (see 5.7.7). As soon as quality control results are given, they are compared to the range of acceptable results, if they are outside the range, the analyzer automatically reruns the controls according to the principle below: First run

Result(s)

Automatic rerun by STA Compact Max®

Control run in single

Outside the defined range

The control is rerun in duplicate

Control run in duplicate

1 of the 2 results is outside the defined range

The control is rerun in single

If the quality control is confirmed as outside the range of acceptable results, all the patient results for the related methodology will be given with the alarm: "Quality Control: out of range or not done" in the Patient file. If the operator decides to accept quality control results declared as out of range, all patient results for the related methodology are associated with the alarm: "Quality control: forced confirmation". If quality controls are run or rerun, the analyzer performs a consistency check when the operator returns to the Test panel. Then, the window Products - Analysis status appears (see B.5). If upon running quality controls (automatically or on request), the quality controls are not in the product drawer (absent or present but with incorrect volume or stability) and if the last quality control was run less than 24 hours ago, then the STA Compact Max® does not run the control, proceeds with the analyses for the related methodology and all patient results for the related methodology are given with the alarm: "Quality control: out of range or not done". In the same case, with a period exceeding 24 hours, the sample pipetting for the related methodology is blocked. If the control lot number has changed or if the quality control results have been reseted, the sample pipettings for the related methodology resume only when the products required to perform the first controls are loaded. In the same way, sample pipettings are blocked as long as the threshold values for the related methodology have not been defined.

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If the same controls are used as calibration controls and quality controls (same identification numbers), the calibration control results are integrated in the quality control cumulative totals. The clock for the quality controls is reset when calibration controls are run (see 4.2.1).

If Online transmission option is enabled (see chapter 7 ), quality control results are sent as soon as the measurements are obtained, taking error codes into account. No alarm codes are sent for quality controls. Each quality control result is sent with the date and time at which they were run. If Online transmission option is unabled, all the validated results of the quality controls for the day may be sent from the table (or graph) of the quality control results (see chapter 7 ).

4.3.2.2

Loading Quality Controls The quality controls are loaded in the product drawer (see 3.3.2). At each lot number change, the threshold values for Diagnostica Stago STA® quality controls are scanned by means of the assay value inserts included in each control box. For the other controls, the threshold values have to be typed manually. For Diagnostica Stago products, threshold values are properly dispatched in the related methodologies provided the primary unit chosen for these products is identical to the one defined in the package inserts included in each product box. Fibrinogen exception: for g/l primary unit, values are properly dispatched even if they are given in mg/dl in the package insert.

4.3.2.3

Changing the threshold values for quality controls This procedure is only possible if the operator knows the access code to critical functions (see chapter 7 ). For controls which are not from the STA® product line, threshold values must be defined at every lot change so that controls can be run. For controls from the STA® product line, the threshold values can only be reduced, they can never be increased.

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Quality control result screen displayed (graphic format) for a selected level (see B.9.2) " Click Modify threshold.  The following window appears Fig. 4 - Threshold modifications window

" Type the new thresholds and click Confirm.  The Threshold modifications window disappears.  A window requesting the access code appears. " Type the access code and then click Confirm.  The control result screen reappears with the new range values.  In areas, Controls of the day and Daily cumulative totals, all the points that are outside the newly defined thresholds are displayed in red.

4.3.2.4

Running a quality control level Running the quality control is impossible: -

for methodologies requiring a control that is being used or which has to be validated,

-

for methodologies which calibrations have not been validated,

-

for methodologies which quality control threshold values have not been defined (see 4.3.2.3).

Quality control result screen displayed (graphic format) for a selected level (see B.9.2) " Click Start.  A window requesting the access code appears. " Type the access code and then click Confirm.  The quality control starts provided the consistency check does not lead to a blocking

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of sample pipettings.

" Click

.

 The window Quality controls - Methodologies list reappears.

4.3.2.5

Simplified Running for Quality Controls Running the quality control is impossible: -

for methodologies requiring a control that is being used or which has to be validated,

-

for methodologies which calibrations have not been validated,

-

for methodologies which quality control threshold values have not been defined.

Window Quality controls - Methodologies list (see B.9.1) " Select all the boxes of the methodologies requiring a quality control. " Click

.

 A window requesting the access code appears. " Type the access code and then click Confirm.  Quality controls start provided the consistency check does not lead to a blocking of sample pipettings.  Yellow triangles are displayed on the right of the selected methodologies

4.3.3

.

Procedures to observe for out of range Quality Controls Alarm codes and alarm message displayed for out of range quality controls, see 4.3.3.1 Description of the Quality control out of range window, see 4.3.3.2 Accepting out of range Quality Controls, see 4.3.3.3 Rerunning out of Range Quality Controls, see 4.3.3.4

4.3.3.1

Alarm codes and alarm message displayed for out of range quality controls When a quality control result is outside the range of acceptable results (out of range), the operator is informed by the following message: QUALITY CONTROLS Control out of range for the xxx Continue xxx: abbreviation of the methodology All the patient results for the related methodology are given with the alarm: "Quality Control: out of range or not done" in the Patient file.

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4.3.3.2

Description of the Quality control out of range window The following window is displayed when consulting a quality control with an out of range result. Fig. 5 - Representation of the Quality control out of range window

Quality control out of range Control information Methodology

xxx Abbreviation of the methodology

Identity

xxx Quality control identification number

Result

xxx

xxx

xx

Results obtained for the quality control (in the primary unit)

Thresholds

xxx

xxx

xx

Range of acceptable results for the quality control (in primary unit)

Means Daily cumulative totals

xxx

Monthly cumulative totals

xxx

Confirm

4.3.3.3

Mean for the Daily cumulative totals area

Mean for the Monthly cumulative totals area

Rerun

Postpone Decision

Accepting out of range Quality Controls This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). If the operator decides to accept quality control results declared as out of range, all patient results for the related methodology are associated with the alarm: "Quality control: forced confirmation". In the Quality control out of range window, out of range results are displayed in red and the range of acceptable results is displayed (see 4.3.3.2).

Quality control result screen with the Quality control out of range window " Click Confirm.  A window requesting the access code appears. " Type the access code and then click Confirm.  Depending on the value of the out of range result, a red " " or a red "S" (out of scale) is displayed in the Controls for today area. " Click

.

 The window Quality controls - Methodologies list reappears.

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4.3.3.4

Rerunning out of Range Quality Controls When the STA Compact Max® declares a quality control as out of range, the control has already been run 3 times. Indeed, if a control result is outside the range of acceptable results, for a single determination, the control is rerun in duplicate and for a duplicate determination, it is rerun in single (see 4.3.2.1). In the Quality control out of range window, out of range results are displayed in red and the range of acceptable results is displayed (see 4.3.3.2).

Quality control result screen with the Quality control out of range window " Click Rerun.  A window requesting the access code appears. " Type the access code and then click Confirm.  The quality control is rerun provided the consistency check does not lead to a blocking of sample pipettings.  The quality control result screen reappears.

4.3.4

Other available operations on Quality Controls Cancelling a quality control, see 4.3.4.1 Deleting controls of the day, see 4.3.4.2 Deleting all results of Quality controls, see 4.3.4.3 Printing Quality Control results, see 4.3.4.4 Transmitting today’s Quality Control results, see 4.3.4.5

4.3.4.1

Cancelling a quality control This function is not available if the control status is valid, to be validated or not done. It is only possible for controls in progress (yellow triangle

at the right of the methodology).

Quality control result screen displayed (graphic format) for a selected level " Click Cancel.  A window requesting the access code appears. " Type the access code and then click Confirm.  The quality control for the selected level is cancelled. " Click

.

 The window Quality controls - Methodologies list reappears.  A red triangle is displayed on the right of the selected methodology (not done

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4.3.4.2

Deleting controls of the day This function is only possible for methodologies with controls in progress or to be validated. This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). It only concerns quality control results of the controls of the day area.

Screen of quality control results for a selected level " From the table of results, Daily controls table, select the results that have to be deleted then click Delete.  A window requesting the access code appears. " Type the access code and then click Confirm.  In the Controls of the day area, the selected results are no longer displayed.  Mean, σ and cv are updated. " Click

.

 The window Quality controls - Methodologies list reappears.

4.3.4.3

Deleting all results of Quality controls

This operation deletes all quality control results for a selected level.

This procedure is only possible if the operator knows the access code to critical functions (see 7.3.4). This function is not available if the control status is in progress or if it has to be validated.

Quality control result screen displayed (graphic format) for a selected level " Click Delete points.  A window requesting the access code appears. " Type the access code and then click Confirm.  A message requesting a confirmation of the deletion appears. " Click Confirm.  All quality control results of the selected level are deleted.  Mean, σ and cv are updated. " Click

.

" The window Quality controls - Methodologies list reappears.

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4.3.4.4

Printing Quality Control results This operation is possible only if the STA Compact Max® is in stand-by mode (no measurement in progress) and if all printouts previously requested have been made.

Screen of quality control results for a selected level Printing graphics " Click

.

 The following window appears Fig. 6 - Printout window

" Select Print then click Confirm.  A graphic format of the selected level quality control results are printed. " Click

.

 The window Quality controls - Methodologies list reappears. Printing tables

" Click

and then

.

 The Printout window appears (see figure 6). " Select Print then click Confirm.  A table format of the selected level quality control results are printed. " Click

.

 The window Quality controls - Methodologies list reappears.

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4.3.4.5

Transmitting today’s Quality Control results

Screen of quality control results for a selected level " Click

.

 A message informing that the transmission is in progress appears.  All today’s quality control results for the selected level are transmitted to the Host computer with the date and time at which they were run.

" Click

.

 The window Quality controls - Methodologies list reappears.

4.4

Running analyses Running or stopping analyses may also be requested from the Analysis status window (see B.5). As soon as the operator confirms the analyses request, the samples are processed the following way: -

Pipetting of calibrators for all analyses.

-

Pipetting of calibration controls for all analyses.

-

Pipetting of quality controls for all analyses.

-

Pipetting of urgent samples.

-

Pipetting of samples for all analyses according to their chronological loading order.

Loading products window, loading of product(s) complete (see B.2) OR Loading samples window, loading of sample(s) complete (see B.3)

" Click

.

 The sample (or product) drawer closes automatically.  Sample pipettings start and the Analysis status window is displayed when all the conditions are met for all the reagents and products. - Quality controls and calibrations are ok. - No stability is overdue. - All the volumes are sufficient.  If one of the above-mentioned conditions is not met, for one or several reagent(s), the sample pipetting is blocked and the Analysis status window appears along with the

Pipetting Blocked symbol

.

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" If sample pipettings have been blocked, click

.

 The following message appears: WARNING Analyses executions have been stopped Do you want to reactivate them? Yes

No

" To reactivate analyses, click Yes. Only analyses satisfying at least the following conditions can be reactivated: correct calibration, quality control, volume and stability. All the other analyses remain blocked.  The authorized sample pipetting starts again.  The Test panel reappears. " To keep blocking analyses, click No.  The Test panel reappears. " Depending on the situation: - Load the missing products. - Replace the products which volumes are insufficient or which stability is almost overdue. - Validate or run the required calibrations and quality controls. - Change the threshold values of the non STA® line controls and calibrators. Blocking pipettings " To block all the pipettings, click Block pipetting. NOTE: pipettings are automatically unblocked if all the products required for an analysis or calibration are onboard.

4.5

Switching the analyzer off When all analyses are complete, the STA Compact Max® goes in stand-by mode: automatic functions stop except for the temperature regulations. It is recommended to keep the analyzer on and to keep the products onboard. This way, the STA Compact Max® automatically manages the stability of products. To temporarily stop sample pipettings, click Block pipetting from the Test panel. To switch off the STA Compact Max®, follow the procedure described hereafter: " Unload all samples and diluent vials from the sample drawer (see 3.3.7). " Unload all vials from the product drawer (see 3.3.7). " From the Test Panel, click

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STOP THE PROGRAM? Yes

No

 The system starts a backup of the current status of the analyzer and the following messages appear: PROGRAM STOPPED Saving in progress Please wait... DO NOT SWITCH OFF

Please wait

It is now safe to turn off your computer " Switch off the STA Compact Max® (O) (switch located on the left-hand side) (see 2.5.4). " Switch off the monitor. " Switch off the printer. Extended stop of the STA Compact Max® If the STA Compact Max® has to be switched off for more than 8 days, follow the procedure described hereafter: " Unload all samples and diluent vials from the sample drawer (see 3.3.7). " Unload all vials from the product drawer (see 3.3.7). " Remove bottles (used liquid and STA® Cleaner). " Eliminate waste containers (used liquid and cuvettes) in accordance with local regulations. " Decontaminate the analyzer: -

Clean the washing wells and purge the needles (see 8.4.2.2).

-

Clean the sample and product drawers as well as the measurement plate (see 8.3.4 and see 8.3.5).

"

Switch off the STA Compact Max®.

Before switching the instrument back on: " Follow the same decontamination procedure. " Put the used liquid and cuvette containers back in place. " Check the Peltier reservoir level (see 8.3.3).

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Table of contents

5

Methodology management . . . . . . . . . . . . . . . . . . . .

1

5.1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

5.2

Creating a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

5.2.1 Creating a main methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

5.2.2 Creating a dependent methodology . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

5.2.2.1 General information on dependent methodologies . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

5.2.2.2 Creating and setting up a dependent methodology . . . . . . . . . . . . . . . . . . . . . . . . . .

4

5.2.3 Creating a calculated methodology . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

5.2.3.1 General information on calculated methodologies . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

5.2.3.2 Creating and setting up a calculated methodology . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

5.3

10

Modifying a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.3.1 Modifying a methodology parameter . . . . . . . . . . . . . . . . . . . . . . . . . .

11

5.3.2 Saving the modifications made to a methodology . . . . . . . . . . . . . . . .

11

5.4

Installing and updating STAGO methodologies . . . . . . . . . .

14

5.5

Modifying the display order of the methodology list . . . . . . . .

14

5.6

Deleting a methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

5.7

Page 1/3 of a methodology parameters: section Methodology 16

5.7.1 Identification section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

5.7.2 Sample section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

5.7.3 Diluent section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

5.7.4 Reagent section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

5.7.5 Definition of washing options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

5.7.5.1 Defining sample washing options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

5.7.5.2 Defining reagent washing options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

5.7.6 Analysis section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26

5.7.6.1 Clotting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

5.7.6.2 Colorimetry or kinetic O.D./minute immunology

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

28

5.7.6.3 Colorimetry or kinetic O.D./minute immunology

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

29

5.7.7 Section Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

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Table of contents

5.7.8 Section Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

5.7.9 Section Redilution criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

5.8

Page 2/3 of a methodology parameters: section Calibration.

33

5.8.1 Pages 2/3 depending on the calibration mode . . . . . . . . . . . . . . . . . . .

33

5.8.1.1 Page 2 of a methodology in Graphic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34

5.8.1.2 Page 2 of a methodology in bar codes mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

5.8.1.3 Page 2 of a methodology in Raw mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

36

5.8.1.4 Page 2 of a methodology in Ratio mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

5.8.2 Defining the calibration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

5.8.3 Defining the offset correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38

5.8.4 Defining calibration controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39

5.8.5 Defining scales (graphic or bar codes mode) . . . . . . . . . . . . . . . . . . . .

40

5.8.6 Defining calibrators (graphic mode) . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

5.8.7 Defining the determination of calibrators (graphic mode) . . . . . . . . . . .

42

5.8.8 Defining display points (bar codes mode) . . . . . . . . . . . . . . . . . . . . . .

42

5.9 Page 3/3 of a methodology parameters: section Quality Controls and Printout/transmission 43 5.9.1 Section Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

5.9.2 Section Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

45

5.9.3 Section Usual values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

5.9.4 Section Printout Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

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Methodology management

5

Methodology management Overview, see 5.1 Creating a methodology, see 5.2 Modifying a methodology, see 5.3 Installing and updating STAGO methodologies, see 5.4 Modifying the display order of the methodology list, see 5.5 Deleting a methodology, see 5.6 Page 1/3 of a methodology parameters: section Methodology, see 5.7 Page 2/3 of a methodology parameters: section Calibration, see 5.8 Page 3/3 of a methodology parameters: section Quality Controls and Printout/ transmission, see 5.9

5.1

Overview The word Methodology refers to the operating mode implemented to perform an analysis. A set of parameters defines each methodology. 1 to 12 methodologies may be associated to a file at the loading, see 3.3.4.4. Screen Methodology displays a list of all the methodologies available in the analyzer. Screen Methodology gives access to the display and modification of each methodology parameters.

Please, read the warnings: see 1.4 Warnings concerning methodologies.

STA Compact Max® manages three kinds of methodologies. -

Main methodologies.

-

Dependent methodologies

.

A dependent methodology is created from a main methodology, see 5.2.2. -

Calculated methodologies

.

A calculated methodology is created from two methodologies, see 5.2.3.

Test Panel screen " Click Methodologies.

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 Screen Methodologies is displayed. Fig. 1 - Methodologies screen

NOTE: when measurements are in progress, only the Consult button is available. Modification of the parameters is not possible.

Mark

Description

1

Updating Stago methodologies.

see 5.4

2

Creating a dependent methodology.

see 5.2.2

3

Creating a main or a calculated methodology.

see 5.2

4

Modifying the selected methodology.

see 5.3

5

Modifying the display order inside the list of methodologies.

see 5.5

6

Modifying the selected non Stago methodology.

see 5.6

Mark

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Action

Action

Description

1

Updating Stago methodologies.

see 5.4

2

Creating a dependent methodology.

see 5.2.2

3

Creating a main or a calculated methodology.

see 5.2

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Mark

Action

Description

4

Modifying the selected methodology.

see 5.3

5

Modifying the display order inside the list of methodologies.

see 5.5

6

Modifying the selected non Stago methodology.

see 5.6

" Click Modify or click Consult in order to display the parameters of the selected methodology. " Click

,

or

to go from one page of the methodology to another.

NOTE: The operator can modify fields with a white background but not fields with a gray background. Each main methodology has 3 pages for the definition of parameters: -

Page 1/3 for the methodology (see 5.7).

-

Page 2/3 for the calibration (see 5.8).

-

Page 3/3 for the result printout and transmission and for the quality controls (see 5.9).

Each dependent methodology has 1 page for the definition of parameters (see figure 2). Each calculated methodology has 1 page for the definition of parameters (see figure 3).

5.2

Creating a methodology

Prerequisites: - The STA Compact Max® is in stand-by mode (no measurement in progress). - The operator knows the access code (see 7.3.4). - No related methodology appears in any patient file. - No calibration and no quality control are in progress on the concerned parameter.

For a description of the parameters of the methodologies see 5.7, 5.8 and 5.9. Creating a main methodology, see 5.2.1 Creating a dependent methodology, see 5.2.2 Creating a calculated methodology, see 5.2.3

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5.2.1

Creating a main methodology

Test panel. The STA Compact Max® is in stand-by mode (no measurement in progress). " Click Methodologies.  Screen Methodology is displayed (see figure 1) " Position the cursor right after the last methodology of the list. " Click Create. " Click

,

or

to go from one page of the methodology to another.

" Type or select data for the required parameters (see 5.3). For a description of the parameters of the methodologies see 5.7, 5.8 and 5.9. " When the 3 methodologies pages are set, proceed to the validation (see 5.3.2).

5.2.2

Creating a dependent methodology General information on dependent methodologies, see 5.2.2.1 Creating and setting up a dependent methodology, see 5.2.2.2

5.2.2.1

General information on dependent methodologies Each methodology can have up to 8 dependent methodologies. Each dependent methodology differs from its main methodology with respect to dilution, correction factor and transmission ranks. -

Performance of the analysis: The dependent methodology uses all the parameters of its main methodology except for dilution.

-

Result calculation: The dependent methodology uses its main methodology calibration but with its own correction factor.

-

Result transmission: The dependent methodology uses its own transmission ranks.

For example, dependent methodologies can be used for determination of multiple dilution factors. These methodologies can neither be used as main methodologies nor as primary methodologies.

5.2.2.2

Creating and setting up a dependent methodology

Test panel. The STA Compact Max® is in stand-by mode (no measurement in progress). " Click Methodologies.  Screen Methodologies is displayed. " Select the main methodology on which the dependent methodology will be based.

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" Click

.

 Screen Methodologies - Dependent methodologies is displayed.

Fig. 2 - Screen Methodologies - Dependent methodologies

Legend: 1. List of dependent methodologies. 2. Button Modify enabling modification or creation of a dependent methodology. 3. Recall of some parameters of the main methodology. 4. Definition of the parameters of the dependent methodology. Abbreviation, see 5.7.1. Name, see 5.7.1. Dilution, see 5.7.2. Correction factor, see 5.7.7. Units, see 5.9.2. Transmission rank, see 5.9.2. A. Button Confirm to confirm the modification or creation of dependent methodology. B. Button Cancel to allow the cancellation of the modification or creation of a dependent methodology. " Position the cursor right after the last methodology of the list. " Click Modify.  The first modifiable parameter is available. " Type or select data for each required parameter (see 5.3). " When the dependent methodology is set up, click Confirm.

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 The following window appears:

WARNING SAVE CHANGES? Yes

No

Cancel

" Click Yes and then click

.

 The following window appears: Exit Options Do you want to save the changes made to test setup? Yes

No

Cancel

" Click Yes.  The following window appears: Access code Please enter your access code: Confirm - Cancel " Type the access code and then click Confirm.  Back to the main methodology.  The dependent methodology created is identified by symbol

.

It is not necessary and even not recommended to save the main methodology because the system will reject this request if Patient Files contain the main methodology.

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5.2.3

Creating a calculated methodology General information on calculated methodologies, see 5.2.3.1 Creating and setting up a calculated methodology, see 5.2.3.2

5.2.3.1

General information on calculated methodologies A calculated methodology is based on two main methodologies then called primary methodologies. Calculated methodologies are methodologies for which the result is a calculation expression using one of these 2 formulae: -

(R1 / R2) x K

-

(R1 - R2) x K

R1, R2: Results not limited to the printout limits expressed as raw data for the 2 primary methodologies. K: Programmable coefficient. Thus a result can be given that is either equal to a ratio between two methodologies or to a difference. Result unit is implicit: ratio in case of a ratio calculation or raw unit in case of a difference calculation. Secondary units do not have to be defined for calculated methodologies. The two primary methodologies used must be based on the same measurement method: clotting time, colorimetry or immunology. Results of the calculated methodologies are given only when the primary methodology result status is "to be validated", "confirmed", "Dev. > tol.", or "M > Mmax." (="T > Tmax."). Results of calculated methodologies cannot be manually confirmed: their confirmation implicitly follows primary methodologies confirmation. Results from calculated methodologies have as error and alarm codes, the most serious error code and the most serious alarm code among those assigned to their primary methodologies. Only alarm code H (result in primary unit limited to printout limit values) is an exception to this rule because it directly applies to the values obtained for the calculated methodology. Calculated methodologies cannot be rerun. There is neither calibration nor quality control for calculated methodologies. These methodologies can neither be used as main methodologies nor as primary methodologies. Procedures to access, modify or create these methodologies are identical to those described for the main methodologies.

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5.2.3.2

Creating and setting up a calculated methodology

Test Panel screen " Click Methodologies. " Position the cursor right after the last methodology of the list. " Click Create.  Page

is displayed.

" In section Identification, field Abbreviation: type the abbreviation of the new methodology. " In section Identification, field Method: select calculated result.  Window Calculated methodology is displayed. " Type or select data for each required parameter (see 5.3). " When the calculated methodology is set up, click

.

 The following window appears: Exit Options Do you want to save the changes made to test setup? Yes

No

Cancel

" Click Yes.  The following window appears: Access code Please enter your access code: Confirm - Cancel " Type the access code and then click Confirm.  Back to the main methodology.  The calculated methodology thus created is identified by symbol

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Fig. 3 - Calculated methodology set up

Identification (see figure 3, mark 1) Abbreviation (8 characters)

Abbreviated name of the methodology.

Name (25 characters)

Full name of the methodology.

Method

Calculated Result.

Primary methodologies (see figure 3, mark 2) Abbreviation

Click in order to select primary methodology 1 and primary methodology 2 in the list of available methodologies abbreviations. Reminder: Both primary methodologies must be based on the same measurement method.

Name

Full name of each primary methodology. The full name is automatically displayed once the abbreviation has been selected.

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Calculation (see figure 3, mark 3) Formula

Formula type: - Ratio calculation: (Result 1 / Result 2) x K - Difference calculation: (Result 1 - Result 2) x K Reminder: Results not limited to the printout limits expressed as raw data for the two primary methodologies.

Coefficient K

Coefficient that can be set between 0.001 and 9999.999.

Printout/Transmission (see figure 3, mark 4) Unit

- Ratio for a ratio calculation. - Raw for a difference calculation.

Printout

: The unit appears on printouts. : The unit does not appear on printouts.

Transmission rank

To transmit the result: indicate the transmission rank corresponding to the host computer. If the result does not need to be transmitted: indicate 0. If necessary, click then, click Reset to indicate 0.

Printout limits (see figure 3, mark 5) Minimum

Result minimum acceptance value.

Maximum

Result maximum acceptance value.

Any result out of this range is automatically reported either as the minimum value or as the maximum value and is marked with an alarm code.

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5.3

Modifying a methodology Prerequisites: - The STA Compact Max® is in stand-by mode (no measurement in progress). - The operator knows the access code. - The methodology that must be modified is not included in any patient file. - No calibration and no quality control are in progress on the concerned parameter.

Modifying certain parameters may have very important consequences: - Invalidation of calibrations, - Deletion of quality control results. Modifying a methodology parameter, see 5.3.1 Saving the modifications made to a methodology, see 5.3.2

5.3.1

Modifying a methodology parameter

Test Panel screen " Click Methodologies. " Select the methodology that needs to be modified then click Modify. " Click , or to go from one page of the methodology to another. For a description of the parameters of the methodologies see 5.7, 5.8 and 5.9. " Type or select data for the required parameters: The operator may modify fields with a white background but not fields with a gray background. Free entry fields: - Click in the field and type the data. Multiple-option fields: - Click

then click the requested parameter.

or - Click

then fill in the required parameters. Click

then click Yes to validate or

click Confirm. " When all the modifications have been made, see 5.3.2 to save the modifications.

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5.3.2

Saving the modifications made to a methodology

Page 1, 2 or 3 of a methodology with modified parameters. " When all the modifications have been made, click

.

 The following window appears:

Exit Options Do you want to save the changes made to test setup? Yes

No

Cancel

" Click Yes.  The software checks the consistency of the methodology parameters. -

In case of detected inconsistency, a window describing the error appears. Read carefully the displayed message then click

. Correct the problem as required and resume

the validation procedure. -

If no inconsistency is detected, the following window appears:

Access code Please enter your access code: Confirm - Cancel " Type the access code and then click Confirm.  The software checks if any critical parameters have been modified (for example: incubation time, reagent volumes). -

If no critical parameter has been modified, the following message appears:

Information Saving in progress Please wait...  The methodology is saved.  The Methodologies menu is displayed. " Click

.

 A message advising the operator to save the methodologies is displayed.

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" Click

to close the message window.

 The Test panel is displayed. " Proceed to the data saving: see 8.4.2.5 -

If a critical parameter has been modified:  A message informs the operator of the modification consequences.

Setup IMPORTANT CHANGES DETECTED THE FOLLOWING OPERATIONS WILL BE PERFORMED Calibration

invalidated

Quality controls

deleted

Type Yes to confirm: Confirm

Abort

The displayed message depends on the nature of the modified parameter. - Calibration not valid: operator must rerun the calibration for the concerned methodology. - Deleted quality controls: the results of the quality control level(s) for the relevant methodology are deleted. " If the consequences are accepted, type YES then click Confirm.  The methodology is saved.  Calibrations or quality controls are required for the methodology.  The Methodologies menu is displayed. " Click

.

 A message advising the operator to save the methodologies is displayed. " Click

to close the message window.

 The Test panel is displayed. " Proceed to the data saving: see 8.4.2.5

In case of modification of a methodology included in a patient file which tube is onboard, the analysis will not be run.

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5.4

Installing and updating STAGO methodologies Refer to the documentation provided with the methodology CD-ROM.

5.5

Modifying the display order of the methodology list The operator may modify the display order inside the list of methodologies.

Methodologies window. Analyzer in stand-by mode (no measurement in progress). " Select the methodology that has to be moved then click Move.  The moved methodology is identified by a yellow arrow.  The message "Please select the position where the methodology should be inserted" appears at the bottom of the screen. " Use the mouse to move the yellow arrow to the required position and then click Confirm.  The following window appears: INFORMATION Processing modification in progress. Please wait...  Back to the Methodologies window. The methodology display order is modified in all the windows where they appear. " Repeat the operation if necessary.

5.6

Deleting a methodology Methodologies created by the operators may be deleted. Methodologies provided by Diagnostica Stago cannot be deleted.

Prerequisites: - The STA Compact Max® is in stand-by mode (no measurement in progress). - The operator knows the access code (see 7.3.4). - The methodology that must be deleted is not a methodology provided by Diagnostica Stago. - No related methodology appears in any patient file.

If the methodology about to be deleted is a main methodology, all the methodologies depending on this methodology will be deleted too.

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Methodologies window. Analyzer in stand-by mode (no measurement in progress). " Select the methodology that has to be deleted. " Click Delete.  The window Delete methodology appears.

Fig. 4 - Example of a Delete methodology window.

" Click Continue to confirm the deletion of the selected methodology.  The following window appears: Access code Please enter your access code: Confirm - Cancel " Type the access code and then click Confirm.  The following window appears:

Delete methodology Abbrev. XXX Name

XXX

DELETING IN PROGRESS... Please wait...  When a methodology is deleted the Methodologies window reappears.

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If the methodolgoy that has to be deleted is used in a Patient file, the following window appears:

Delete methodology Abbrev. XXX Name

XXX

Some files still have this methodology in memory CANNOT DELETE

" Click

to close the message window.

 Back to the Methodologies window.  The methodology is not deleted.

5.7

Page 1/3 of a methodology parameters: section Methodology Test Panel screen " Click Methodologies.  The Methodologies menu is displayed. " Select the methodology that has to be displayed. " Click Modify or click View in order to display the parameters of the selected methodology. NOTE: The operator can modify fields with a white background but not fields with a gray background.

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Fig. 5 - Page 1 of the methodology

Legend: 1. Date of the last modification saved by the operator. 2. Identification of the methodology (see 5.7.1). 3. Sample parameters (see 5.7.2). 4. Washing options after each sample pipetting (see 5.7.5.1). 5. Diluent parameters (see 5.7.3). 6. Parameters for each reagent (see 5.7.4). 7. Washing options before and after each pipetting of the concerned sample (see 5.7.5.2). 8. Analysis parameters (see 5.7.6). 9. Result parameters (see 5.7.7). 10. Value range for automatic confirmation of the results (see 5.7.8). 11. Automatic redilution parameters (see 5.7.9). 12. Access buttons for the other methodology pages.

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5.7.1

Identification section

Page 1 of a methodology parameters, see figure 5 mark 2.

Abbreviation

Abbreviation of the methodology (8 characters)

Name

Full name of the methodology (25 characters)

Method

Type of measurement method: Clotting Colorimetry: - Kinetic 2 points - Kinetic OD/minute Immunology: - Kinetic 2 points - Kinetic OD/minute Calculated result: - see 5.2.3

5.7.2

Sample section

Page 1 of a methodology parameters, see figure 5 mark 3.

Volume µl

Final Sample Volume: expressed in microliters, after dilution if necessary (from 25 µl to 200 µl in graduations of 5 µl).

RISK OF INCORRECT RESULTS Total volume (sample + reagents) must be between: - 150 µl and 400 µl for clotting methods - 250 µl and 400 µl for photometric methods. Incub. sec

Incubation time of the plasma alone in seconds (from 0 to 999 seconds). 0: no defined incubation. Application of the incubation time of the Intermediate reagent distributed afterwards (see 5.7.4, Incubation schema description)

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Dilution

Type of dilution. 1/1,

1/2,

1/3,

1/4, 1/5, 1/6,

1/7,

1/8,

1/10, 1/12, 1/15, 1/20,

1/30, 1/40, 1/50, 1/60, 1/80, 1/100, 1/160, 1/200, 1/400

- The 1/400 dilution is not possible when the sample volume is less than 50 µl. NOTE: 1 / 6 = 1 sample volume + 5 diluent volumes to get 6 preparation volumes. Washing

Washing options after each sample pipetting. - Normal: 5 pulses (with STA® Cleaner) - Intensive: may be set with 10 to 25 pulses (with STA® Cleaner) - Special: with the selected cleaner and rinsing with STA® Cleaner " To modify the washing definition, see 5.7.5.1.

5.7.3

Diluent section

Page 1 of a methodology parameters, see figure 5 mark 5.

Identity

Diluent identification (8 characters)

Name

Diluent name (6 to 15 characters)

Volume

Initial volume of the diluent vial in millilitres (ml).

Shelf-life

Diluent stability on the STA Compact Max® in hours (h). The stability is checked when reagents are loaded into the STA Compact Max®.

Min. volume

Minimum diluent volume in millilitres (ml) required for the STA Compact Max® to keep on pipetting in the vial.

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5.7.4

Reagent section

Page 1 of a methodology parameters, see figure 5 mark 6. Each methodology may use 1 to 4 reagents. Intermediate reagents are identified according to their distribution order (Ra, Rb or Rc). Rd is for the start reagent. The sample and reagent incubation schema must follow one of the sequences described in the Incubation schema (see hereafter).

Incubation schemas Sample

Distribution

Incubation

Distribution

Incubation

Distribution

A

Sample

/

Incubation defined for the sample

/

/

Rd

B

Sample

Ra

Incubation defined for Ra

/

/

Rd

C

Sample

Ra + Rb

Incubation defined for Rb

/

/

Rd

D

Sample

Ra + Rb + Rc

Incubation defined for Rc

/

/

Rd

E

Sample

Ra

Incubation defined for Ra

Rb

Incubation defined for Rb

Rd

F

Sample

Ra + Rb

Incubation defined for Rb

Rc

Incubation defined for Rc

Rd

Id.

Alphanumeric identification of the reagent. (8 characters)

Name

Reagent name (6 to 15 characters)

Incub.

Incubation time of the reagent in seconds (from 0 to 999 seconds).

(sec)

0: no defined incubation. Application of the incubation time of the reagent distributed afterwards. Minimum incubation time = 30 seconds.

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Prec.

The incubation time may exceed 30 seconds at most. : critical incubation. The incubation time may exceed 5 seconds at most.

Exceeding incubation time leads to the cancellation of the analysis (cuvette disposed of in the bin) and to the rerun of that same analysis. The box must be selected only for actual critical incubations. Vol. taken

Pipetted reagent volume for an analysis, in microlitres (from 25 µl to 200 µl in graduations of 5 µl).

RISK OF INCORRECT RESULTS Total volume (sample + reagents) must be between: - 150 µl and 400 µl for clotting methods - 250 µl and 400 µl for photometric methods. Vol. vial

Initial volume of the reagent vial (in millilitres).

Min. Vol.

Minimum reagent volume (in millilitres) required for the STA Compact Max® to keep on pipetting in the vial.

( ml) Stab. (h)

Reagent stability on the STA Compact Max® (in hours). The stability is checked when reagents are loaded into the STA Compact Max®.

Washing

Washing options before and/or after each pipetting of the concerned sample. " To modify the washing definition, see 5.7.5.2.

Before

Washing options before each reagent pipetting. - No: no pre-wash - Special: pre-wash with the selected cleaner and rinsing with STA® Cleaner

After

Washing options after each reagent pipetting: - Normal: 5 pulses (with STA® Cleaner) - Intensive: may be set with 10 to 25 pulses (with STA® Cleaner) - Special: washing with the selected cleaner and rinsing with STA® Cleaner

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5.7.5

Definition of washing options

Fig. 6 - Methodologies window - washing options

Defining sample washing options, see 5.7.5.1 Defining reagent washing options, see 5.7.5.2

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5.7.5.1

Defining sample washing options

Methodologies window. Sample section. Washing field (see figure 6) " Click

to display or define the washing options after each sample pipetting.

 The Sample washing window appears.

Fig. 7 - Sample washing window.

Type

3 types of washing to be selected from the pull-down menu: - Normal: 5 pulses with STA® Cleaner. No parameter required. - Intensive: 10 to 25 pulses with STA® Cleaner. - Special: washing with the cleaner selected from the following fieds and rinsing with STA® Cleaner.

Number of pulses

Definition of the Number of pulses. - Normal washing: 5 pulses (cannot be modified) - Intensive washing: select the number of pulses from the pull-down menu - Special washing: no number of pulses defined

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Cleaner identity

Alphanumeric identification of the cleaner (for the Special washing).

Cleaner name

Complete name of the cleaner (for the Special washing) (6 to 15 characters)

Vial volume

Initial volume of the reagent vial in millilitres (for the Special washing).

ml Minimum volume

Minimum cleaner volume (in millilitres) required for the STA Compact Max® to keep on pipetting in the vial (for the Special washing).

ml Shelf-life

Cleaner stability on the STA Compact Max® (in hours) (for the Special washing)

h

The stability is checked when the cleaner is loaded into the STA Compact Max®.

" Click

to close the window.

 The following window appears: SAVE CHANGES Yes -

No

If no modification must be saved:

" Click No.  Back to page 1/3 of the methodology. -

If modifications must be saved:

" Click Yes.  Back to page 1/3 of the methodology. " Save the modifications as described in 5.3.2.

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5

Methodology management

5.7.5.2

Defining reagent washing options

Methodologies window. Section Reagents . Field Washing (see figure 6) " Click to display or define the pre-washing options (Before) or post-washing options (After) to apply for each pipetting of the selected reagent.  The Reagent washing window appears.

Fig. 8 - Reagent washing window

Before

Washing options before each reagent pipetting. - No: no pre-wash - Special: pre-wash with the cleaner selected from the following fields and rinsing with STA® Cleaner.

After

Washing options after each reagent pipetting: - Normal: 5 pulses with STA® Cleaner. No parameter required. - Intensive: 10 to 25 pulses with STA® Cleaner. - Special: washing with the cleaner selected from the following fields and rinsing with STA® Cleaner.

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5

Methodology management

Number of pulses

Definition of the Number of pulses. - Normal washing: 5 pulses (cannot be modified) - Intensive washing: select the number of pulses from the pull-down menu - Special washing: no number of pulses defined

Cleaner identity

Alphanumeric identification of the cleaner (for the Special washing) (8 characters).

Cleaner name

Complete name of the cleaner (for the Special washing) (6 to 15 characters).

Vial volume

Initial volume of the cleaner vial in millilitres (for the Special washing).

ml Minimum volume

Minimum cleaner volume (in millilitres) required for the STA Compact Max® to keep on pipetting in the vial (for the Special washing).

ml Shelf-life

Cleaner stability on the STA Compact Max® (in hours) (for the Special washing)

h

The stability is checked when the cleaner is loaded into the STA Compact Max®.

" Click

to close the window.

 The following window appears: SAVE CHANGES Yes -

No

If no modification must be saved:

" Click No.  Back to page 1/3 of the methodology. -

If modifications must be saved:

" Click Yes.  Back to page 1/3 of the methodology. " Save the modifications as described in 5.3.2.

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5

Methodology management

5.7.6

Analysis section

Page 1 of a methodology parameters, see figure 5 mark 8. Parameters displayed in this section depend on the measurement method defined in the methodology:

5.7.6.1

-

Clotting, see 5.7.6.1.

-

Colorimetry or kinetic O.D./minute immunology, see 5.7.6.2.

-

Colorimetry or kinetic O.D./minute immunology, see 5.7.6.3.

Clotting

Min. time

Minimum time: shortest time for an analysis. Below this time, no result is given, "Mmax >Mmax

For chronometric analyses, raw measurement greater than the maximum time defined in the methodology screens. For graphic order 2 and order 3 polynomial calibration modes, raw measurement (sec., ∆O.D. or O.D./min.) greater than raw measurement obtained for the highest calibration point. For immunological analyses in kinetic 2 points with graphic order 2 or order 3 polynomial calibration modes, after redilution with parameter Redilution 1, raw measurement still out of range. This message can and must be interpreted only after analysis of the colorimetric graph and of the raw measurement for the first point as defined in the methodology.

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A

Icons, pictograms, status and alarms

Color codes associated with results Max. Time

C

Quality controls out of range detected by the system or not done

D

Quality controls out of range but validated by the operator

E

Liquid Level Detection for needle 3 not controlled

F

Liquid Level Detection for needle 2 not controlled

G

Liquid Level Detection for needle 1 (samples) not controlled

H

Result in primary unit limited to printout values

I

Result obtained after redilution (this redilution is defined in the methodology screens)

D

Result rerun by the operator

K

Temperature of product drawer out of range

L

Preventive maintenance not done for the syringe

Y

Piercing counter inferior to 0

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A

Icons, pictograms, status and alarms

Meaning of symbols associated with quality control graphs

Symbols associated with quality control (QC) graphs

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REFERENCE MANUAL

B

Table of contents

B

Description of the software screens . . . . . . . . . . . . .

1

B.1

Description of the Test panel . . . . . . . . . . . . . . . . . . . . . . . .

2

B.2

Screen Loading products . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

B.3

Screen Loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

B.4

Screen Modifying methodology profiles . . . . . . . . . . . . . . . . .

7

B.5

Screen Analysis status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

B.6

Screen Product status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

B.7

Screen Patient analyses - Patient files . . . . . . . . . . . . . . . . .

12

B.8

Description of the Calibrations screen . . . . . . . . . . . . . . . . .

12

B.8.1 Screen Calibration - Methodologies list . . . . . . . . . . . . . . . . . . . . . . .

13

B.8.2 Pre-calibrated mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . .

14

B.8.3 Raw mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

B.8.4 Ratio mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

B.8.5 Graphic mode calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

B.9

21

Description of the Quality controls screens . . . . . . . . . . . . .

B.9.1 Description of screen Quality controls - Methodologies list . . . . . . . . .

21

B.9.2 Description of a result screen (graphic format) . . . . . . . . . . . . . . . . . .

22

B.9.3 Description of a result screen (table format) . . . . . . . . . . . . . . . . . . . .

25

B.10 Description of the Methodologies screens . . . . . . . . . . . . . .

28

B.10.1 Screen Methodologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

B.10.2 Methodology section (page 1/3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

B.10.3 Calibration section (page 2/3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

B.10.4 Printout/Transmission section of results and quality control (page 3/3)

34

B.11 Description of the System screens . . . . . . . . . . . . . . . . . . . .

35

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B

Table of contents

B.11.1 Screen System status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

B.11.2 Settings 1 screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

B.11.3 Settings 2 screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38

B.12 Description of the Maintenance screens . . . . . . . . . . . . . . .

39

B.12.1 Main screen of the User maintenance menu . . . . . . . . . . . . . . . . . . .

39

B.12.2 Maintenance screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41

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B

Description of the software screens

B

Description of the software screens See Icons, pictograms, status and alarms or click the help button the meaning of the color codes and the pictograms.

for information on

Description of the Test panel, see B.1 Screen Loading products, see B.2 Screen Loading samples, see B.3 Screen Modifying methodology profiles, see B.4 Screen Analysis status, see B.5 Screen Product status, see B.6 Screen Patient analyses - Patient files, see B.7 Description of the Calibrations screen, see B.8 Description of the Quality controls screens, see B.9 Description of the Methodologies screens, see B.10 Description of the System screens, see B.11 Description of the Maintenance screens, see B.12

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B

Description of the software screens

B.1

Description of the Test panel The Test panel screen allows users to keep track of the progress of the analyses of all the files (loaded tubes) in real time. It is also the point of return from all the other menus of the STA Compact Max®.

Fig. 1 - Test panel

Description of the items in figure 1

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1

Menu bar

8

Communication with the host computer

2

Table of analyses results

9

Direct access to sample and diluents loading (opens the samples drawer)

3

Identification of the Patient files: patient files are classified in chronological order of creation

10

Direct access to product loading (opens the product drawer)

4

Position occupied by the tube corresponding to the file in the samples drawer

11

Open the Calibration menu

5

Abbreviation of the methodologies

12

Open the Quality controls menu

6

Primary unit of the results, as defined in the methodology

13

Open the Methodologies menu

7

Display of the results

14

Resume or block pipetting (see 4.4)

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B

Description of the software screens

Menu bar in the Test panel Go to product, cuvette and washing solution loading (see chapter 3 ). Open the Analysis status and Product status screens (see 4.1). Go to the Patient files (see 6.2). Go to sample loading (see 3.3). Open screen Rerun/Delete analyses (see 6.4). Open screen Block/Resume methodologies (see 6.5). Go to the calibrations of each methodology (see 4.2). Go to the quality controls of each methodology (see 4.3). Go to the methodologies (see chapter 5 ). Open screen System status (see 7.1) Go to maintenance (see chapter 8 ). Go to the analyzer settings (definition of the access codes, of the content of the patient report form, of the arbitrary units, of the communications protocol, etc.) (see 7.3). Management of online transmissions and printing (see chapter 7 ). Go to the configuration of customised printouts (see 7.2). See also: Icons, pictograms, status and alarms Patient File Management Loading products and samples Calibrations Quality controls

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B

Description of the software screens

B.2

Screen Loading products Fig. 2 - Screen Loading products

Description of the items in figure 2 1

Product loading panel

7

Select this option for micro volumes

2

Product identity

8

Position of the product in the drawer

3

Product name

9

Confirm load button

4

Volume of product in ml

10

Cancel load button

5

Duration of product stability

11

6

Lot number of the product

Table listing the products on board and the information typed when loading

See also: Icons, pictograms, status and alarms Identifying and loading products

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B

Description of the software screens

B.3

Screen Loading samples Manual mode Fig. 3 - Screen Loading samples (manual mode)

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B

Description of the software screens

Automatic mode Fig. 4 - Screen Loading samples (automatic mode)

Description of the items in figure 3 and 4 1

Information on the loading mode

8

Confirm load button

2

Sample loading panel

9

Cancel load button

3

Sample identity

10

Table listing the samples on board and associated information

4

Select this option for urgent loads

11

Button to change a methodology profile

5

Select this option for micro volumes

12

Button to change the default identity

6

Position of the sample in the drawer

13

7

Methodologies required for the loaded sample

Automatic mode or Manual mode button used to select the loading mode

See also: Icons, pictograms, status and alarms General information on sample loading Identifying and loading diluents (sample drawer)

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B

Description of the software screens

B.4

Screen Modifying methodology profiles Fig. 5 - Screen Modigying methodology profiles

Description of the items in figure 5 1

Methodology profiles panel

5

Button to cancel the changes or the creation of a profile

2

List of applicable profiles

6

Drop-down menu used to select an automatic profile

3

Button to modify or create a profile

7

4

Button to confirm the changes or the creation of a profile

Panel listing the available methodologies

See also: Icons, pictograms, status and alarms Selecting methodologies and defining methodology profiles Methodology management

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B

Description of the software screens

B.5

Screen Analysis status Fig. 6 - Screen Analysis status

Description of the items in figure 6 1

Products on board

7

Quantity currently available and margin for the cuvettes and the washing solution (STA® Cleaner)*

2

Product identification

8

Table to track activity

3

Product name

9

Total number of analyses (including blocked analyses) that the analyzer must run without taking calibrations and controls into consideration

4

Position of the product

10

Number of outstanding analyses

1: sample drawer for diluents 2: product drawer for the others

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B

Description of the software screens

Description of the items in figure 6 5

Available margin

11

6

Status of the calibrations and quality controls for each methodology

Estimated end (hour and minutes) of the requested analyses, provided that sufficient quantities of all the necessary products (reagents, diluents, controls, etc.) are available and their stability does not expire. The estimated end of the analyses is updated every 5 minutes, depending on the products on board.

NOTE: the margin theoretically corresponds to the remaining quantity, once all the analyses have been completed. When the values are negative (insufficient quantity to perform all the analyses), they appear in red. The margin takes account of all the product vials declared present in the analyzer. Positive values represent a surplus. Negative values represent a shortage and are displayed in red. These products must be reloaded for the analyzer to finish the analyses. The products are classified in the following order: -

Products with a negative margin (and a possible stability problem).

-

Products with a risk of expired stability.

-

Products with a positive margin and no stability problem.

See also: Icons, pictograms, status and alarms Analysis status Loading the disposables Identifying and loading products Identifying and loading diluents (sample drawer)

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B

Description of the software screens

B.6

Screen Product status Fig. 7 - Screen Product status

Description of the items in figure 7 1

Table of the products on board

6

Current volume of the product**

2

Identity of the product, as defined in the methodologies*

7

Theoretical end of stability of each product, defined by the day, month and time***

3

Name of the product as defined in the Methodologies

8

Information about the cuvette roll

4

Position of the product

9

Lot number of the roll

10

Number of remaining cuvettes

1: sample drawer for diluents 2: product drawer for the others 5

Lot number of the product For some products which lot number is not controlled, this field stays empty

*The identity is followed by a red triangle appears in the following cases: -

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when the product is unusable. This pictogram

when the volume is insufficient, especially if the volume reaches the minimum volume defined in the Methodologies menu

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B

Description of the software screens

-

if a problem occurs detecting the level, especially if, in relation to the theoretical countdown, the STA Compact Max® does not physically detect the liquid

-

if the stability expires

**By default, the STA Compact Max® takes the volume of the vial following reconstitution, as defined in the Methodologies menu (see chapter 5 ). This volume can be corrected when loading (see 3.3). After each sample pipetting, the sampled volume is deducted from the vial volume, as specified in the Methodologies menu (see chapter 5 ). **The STA Compact Max® uses the stability specified in the Methodologies menu (see chapter 5 ) to calculate this value. However, this stability can be corrected when loading the product (see 3.3). After the product has been loaded (t0), the STA Compact Max® makes the following calculation: t0 + t = T

T = end of stability displayed.

See also: Icons, pictograms, status and alarms Product status Identifying and loading products Identifying and loading diluents (sample drawer) Loading the cuvette roll

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B

Description of the software screens

B.7

Screen Patient analyses - Patient files Fig. 8 - Screen Patient analyses - Patient files

Description of the items in figure 8 1

Only shows the files with the selected statuse(s)

5

Print file button

2

Only shows the files starting with a given prefix

6

Communication with the host computer

3

Shows a selection of files

7

Delete file button

4

Selected file list: each file can also be identified by icons showing its status, whether it has been printed or transmitted, etc.

See also: Icons, pictograms, status and alarms

B.8

Description of the Calibrations screen Screen Calibration - Methodologies list, see B.8.1 Pre-calibrated mode calibration screen, see B.8.2 Raw mode calibration screen, see B.8.3 Ratio mode calibration screen, see B.8.4 Graphic mode calibration screen, see B.8.5

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B

Description of the software screens

B.8.1

Screen Calibration - Methodologies list

Fig. 9 - Calibration screen

Description of the items in figure 9 1

Run calibrations (see 4.2.3)

2

Methodologies list Each methodology is displayed with: - a check box used to select the methodology. The check box is disabled if the methodology cannot be selected. - the abbreviation of the methodology - a red triangle indicating the status of the calibration

3

The full name of the selected methodology

See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.8.2

Pre-calibrated mode calibration screen Graphic mode screen

Fig. 10 - Pre-calibrated mode Calibration screen

Description of the items in figure 10 1

Full name of the methodology

8

Value in seconds for the point corresponding to 100%. Is displayed only if it has been corrected and if the correction is possible*

2

Selected calibration mode

9

ISI coefficient (International Sensitive Index). Is displayed only if INR (International Normalized Ratio) has been chosen as the unit**

3

Date and time of the confirmation of the controls

10

Calibration control results in the primary unit used for the results

4

Theoretical concentration of calibrators in the primary unit used for the results

11

Parameter modification button (see 4.2)

5

For chronometry analyses: the clotting time measured in seconds

12

Confirm modification button

For photometry analyses: ∆OD or OD/min.

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B

Description of the software screens

Description of the items in figure 10 6

Equation of the calibration curve

13

Cancel modification button

7

Graphic representation of the calibration curve

14

Run control button (see 4.2.3)

15

Button to access the calibration information screen

*Correction of the 100%: this option is only possible for chronometry methodologies with % as the primary unit and if the measurement scale is linear and the concentration scale is inverse. It moves the calibration curve in a parallel direction to itself in such a way that the calibration passes through the new point given in seconds and which corresponds to the 100%. **Used to correct the ISI (International Sensitive Index) if the INR unit (International Normalized Ratio) is selected.

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B

Description of the software screens

Information screen

Fig. 11 - Calibration - Information screen (Pre-calibrated mode)

Description of the items in figure 11 1

Full name of the methodology

7

Calibration control identification numbers

2

Selected calibration mode

8

Full name of the calibration controls

3

Date and time of the confirmation of the controls

9

Lot number of each calibration control used for the calibration

4

Reagent identification number

10

Minimum values for each calibration control

5

Full name of the reagents

11

Maximum values for each calibration control

6

Lot number corresponding to the reagents used in the calibration

12

Original threshold values for each calibration control

See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.8.3

Raw mode calibration screen

Fig. 12 - Raw mode Calibration screen

Description of the items in figure 12 1

Full name of the methodology

8

Lot number of the calibration controls

2

Selected calibration mode

9

Minimum threshold for each calibration control

3

Date and time of confirmation of the controls, if they are used

10

Maximum threshold for each calibration control

4

Calibration controls and settings

11

Initial thresholds for each calibration control

5

Identification number, name and lot number of the reagents

12

Run calibration control button (see 4.2.3)

6

Calibration control identification number

13

Confirm modification button

7

Name of the calibration controls

14

Abort button

See also: Icons, pictograms, status and alarms

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REFERENCE MANUAL

B

Description of the software screens

B.8.4

Ratio mode calibration screen

Fig. 13 - Ratio mode Calibration screen

Description of the items in figure 13 1

Full name of the methodology

8

Lot number of the calibration controls

2

Selected calibration mode

9

Minimum threshold for each calibration control

3

Date and time of confirmation of the controls, if they are used

10

Maximum threshold for each calibration control

4

Calibration controls and settings

11

Initial threshold for each calibration control

5

Identification number, name and lot number of the reagents

12

Run calibration control button (see 4.2.3)

6

Calibration control identification number

13

Confirm modification button

7

Name of the calibration controls

14

Abort button

See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.8.5

Graphic mode calibration screen

Fig. 14 - Graphic mode Calibration screen

Description of the items in figure 14 1

Full name of the methodology

9

Calibration settings

2

Selected calibration mode

10

Calibration control results in the primary unit used for the results

3

Date and time of confirmation of the controls, if they are used

11

Button to correct the calibration points

4

Theoretical concentration of calibrators in the primary unit used for the results

12

Offset correction button

5

For chronometry analyses: the clotting time measured in seconds

13

Confirm modification button

For photometry analyses: ∆OD or OD/min. An S appears on the left of deleted values, and an M appears on the left of changed values

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B

Description of the software screens

Description of the items in figure 14 6

Value of calibrators after interpolation from the equation found for the calibration curve (in the primary unit)

14

Cancel modification button

7

Graphic representation of the calibration curve

15

Run calibration button (see 4.2.3)

8

Equation of the calibration curve

16

Button to access the calibration information screen

See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.9

Description of the Quality controls screens Description of screen Quality controls - Methodologies list, see B.9.1 Description of a result screen (graphic format), see B.9.2 Description of a result screen (table format), see B.9.3

B.9.1

Description of screen Quality controls - Methodologies list

Fig. 15 - Screen Quality controls - Methodologies list

Description of the items in figure 15 1

Run quality controls (see 4.3.2)

2

List of methodologies Each methodology is displayed with: - a check box used to select the methodology. The check box is disabled if the methodology cannot be selected. - the abbreviation of the methodology - a red triangle indicating the status of the quality control

3

The full name of the selected methodology

See also: Icons, pictograms, status and alarms

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REFERENCE MANUAL

B

Description of the software screens

B.9.2

Description of a result screen (graphic format) Daily cumulative totals

Fig. 16 - Screen Quality controls - Graphic - Daily cumulative totals

Description of the items in figure 16

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1

Full name of the methodology

12

The range of acceptable results for the quality control is represented by white dotted lines displayed in the three zones: Controls of the day, Daily cumulative totals and Monthly cumulative totals

2

Identification number and name of the control plasma

13

The mean of the range of acceptable results for the quality control is represented by a white line displayed in the three zones: Controls of the day, Daily cumulative totals and Monthly cumulative totals

3

Current lot number of the control plasma

14

The mean zone ±2 σ (σ = standard deviation) of the quality control results for the Daily cumulative totals zone is shown by yellow dotted lines

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B

Description of the software screens

Description of the items in figure 16 4

Primary unit of the results

15

The mean of the quality control results of the Daily cumulative totals zone is shown by a yellow line

5

Display previous level

16

Minimum quality control threshold

6

Display next level

17

Maximum quality control thresholds

7

Display daily cumulative totals (details of the daily cumulative totals: items 9 to 15)

18

Display results in tables

8

Display the monthly cumulative totals

19

Run quality control for the displayed level

9

Daily cumulative totals: zone displaying the last 31 mean values of daily controls*

20

Cancel quality control in progress button for the displayed level

10

Controls of the day: zone displaying the quality control results for a 24hour period**

21

Button to delete all the values shown on the screen

11

Blue vertical bar indicating a lot change for the quality control (up to two lots can be managed)

22

Button to change the acceptance range of the results

*These values do not necessarily correspond to consecutive days. They may even correspond to several months. The day corresponding to each mean is displayed at the foot of the Daily Cumulative Totals zone. New points are added on the right-hand side of the existing points, shifting them one position to the left when there are more than 31 points. In this case, the first point is no longer visible. The means of the daily controls are displayed with different color codes. **When the day changes, as soon as a quality control is confirmed (manually or automatically), this zone is automatically cleared and the point corresponding to the mean of the last 24-hour period is displayed in the Daily cumulative totals zone. In the Controls of the day zone, points are added to the right of the existing points. The results are displayed with different color codes accordingly. See also: Icons, pictograms, status and alarms

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REFERENCE MANUAL

B

Description of the software screens

Monthly cumulative totals

Fig. 17 - Screen Quality controls - Graphic - Monthly cumulative totals

The Monthly cumulative totals zone displays the monthly means of the quality control results. For each calendar month, the mean ± 2 σ is represented: the mean is shown by a yellow line and the mean + 2 σ and the mean - 2 σ by dotted yellow lines. See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.9.3

Description of a result screen (table format) Daily cumulative totals

Fig. 18 - Screen Quality controls - Tables

Description of the items in figure 18 1

Full name of the methodology

9

Button to delete the selected controls

2

Identification number and name of the control plasma

10

Display of the daily cumulative totals (details in the table, item 12)

3

Current lot number of the control plasma

11

Display the monthly cumulative totals

4

Primary unit of the results

12

List of the daily cumulative totals: day when the control was performed and mean of the results of the day

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REFERENCE MANUAL

B

Description of the software screens

Description of the items in figure 18 5

List of daily controls and date when the controls were performed

13

Information on the daily controls: - Range of acceptable results for the current lot of the quality control in the primary unit - Mean (Mean), standard deviation (σ) and coefficient of variation (CV) for the results of the quality controls of the day

6

Check box to select controls to be deleted

14

Lot information panel: mean, standard deviation and coefficient of variation (CV) for the means of the daily controls of the current and old lots

7

Results in the primary unit

15

Display results in graphic format

8

Time when the quality control was performed

16

Communication with the host computer

Monthly cumulative totals

Fig. 19 - Screen Quality controls - Tables - Monthly cumulative totals

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B

Description of the software screens

Monthly cumulative totals displays the last 12 monthly means. The following details are given: -

the month

-

the monthly mean

-

the monthly standard deviation

-

the monthly coefficient of variation

They are displayed: -

in italics for the old lot

-

without italics for the current lot

-

in black when the values are within the thresholds

-

in red when the values are out of range (this applies to Controls of the day, Daily cumulative totals and Monthly cumulative totals)

NOTE: for the month corresponding to the change of lot, the mean corresponds to the mean with the more representative number of points. See also: Icons, pictograms, status and alarms Quality controls Methodology management

B.10

Description of the Methodologies screens Screen Methodologies, see B.10.1 Methodology section (page 1/3), see B.10.2 Calibration section (page 2/3), see B.10.3 Printout/Transmission section of results and quality control (page 3/3), see B.10.4

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Description of the software screens

B.10.1

Screen Methodologies

Fig. 20 - Screen Methodologies

Description of the items in figure 20 1

List of abbreviations of methodologies

5

Move button is used to define the order in which the methodologies appear on the Test panel (see 5.5)

2

Full name of the methodology corresponding to the position of the cursor

6

Delete methodology button (see 5.6)

3

Create methodology button (see 5.2)

7

Go to the history of updates

4

Button used to edit the methodology configuration settings (see 5.3)

8

Create a dependent methodology (see 5.2.2)

NOTE: if measurements are in progress, methodologies can only be accessed in read-only mode (View). See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.10.2

Methodology section (page 1/3)

Fig. 21 - Page 1 of the methodology

Description of the items in figure 21 1

Date of the last modification saved by the operator

7

Definition of the reagent pre-washing and post-washing settings (see 5.7.5)

2

Identification of the methodology section

8

Definition of analysis procedure settings (see 5.7.6)

3

Definition of the sample settings (see 5.7.2)

9

Definition of result settings (see 5.7.7)

4

Definition of the sample washing settings (see 5.7.5)

10

Definition of the range of values for automatic confirmation of the results (see 5.7.8)

5

Definition of the diluent settings (see 5.7.3)

11

Selection of the automatic re-dilution settings (see 5.7.9)

6

Definition of the settings for each reagent (see 5.7.4)

12

Go to pages 1, 2 and 3 of the methodology

See also: Icons, pictograms, status and alarms

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B

Description of the software screens

B.10.3

Calibration section (page 2/3) Page 2 of the methodology differs depending on the selected calibration mode. Graphic mode

Fig. 22 - Page 2 of the methodology for a Graphic mode

Description of the items in figure 22

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1

Abbreviation of the methodology followed by the full name of the methodology

5

Definition of the settings of the offset corrector plasma

2

Definition of the calibration mode

6

Selection of the type of determination for calibrators

3

Definition of the settings for each calibrator

7

Definition of the settings for each calibration control

4

Scale definition

8

Go to pages 1, 2 and 3 of the methodology

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B

Description of the software screens

Barcode mode

Fig. 23 - Page 2 of the methodology for a Barcode mode

Description of the items in figure 23 1

Abbreviation of the methodology followed by the full name of the methodology

4

Scale definition

2

Definition of the calibration mode

5

Definition of the settings for each calibration control

3

Definition of the display points

6

Go to pages 1, 2 and 3 of the methodology

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B

Description of the software screens

Raw mode

Fig. 24 - Page 2 of the methodology for a Raw mode

Description of the items in figure 24

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1

Abbreviation of the methodology followed by the full name of the methodology

3

Definition of the settings for each calibration control

2

Definition of the calibration mode

4

Go to pages 1, 2 and 3 of the methodology

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B

Description of the software screens

Ratio mode

Fig. 25 - Page 2 of the methodology for a Ratio mode

Description of the items in figure 25 1

Abbreviation of the methodology followed by the full name of the methodology

3

Definition of the settings for each calibration control

2

Definition of the calibration mode

4

Go to pages 1, 2 and 3 of the methodology

See also: Icons, pictograms, status and alarms Methodology management

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B

Description of the software screens

B.10.4

Printout/Transmission section of results and quality control (page 3/3)

Fig. 26 - Page 3 of the methodology

Description of the items in figure 26 1

Abbreviation of the methodology followed by the full name of the methodology

4

Definition of the range of usual values

2

Definitions of the settings for each quality control

5

Definitions of the printout limits

3

Definition of the printout and transmission settings

6

Go to pages 1, 2 and 3 of the methodology

See also: Icons, pictograms, status and alarms Methodology management

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B

Description of the software screens

B.11

Description of the System screens Screen System status, see B.11.1 Settings 1 screen, see B.11.2 Settings 2 screen, see B.11.3

B.11.1

Screen System status

Fig. 27 - System status screen

Description of the items in figure 27 1

Button to set the date and time

5

Availability: - Number of remaining cuvettes (displayed in black). When there are 20 or less cuvettes left, this number is displayed in red. - Quantity of washing solution (STA® Cleaner) remaining (displayed in black). When 50 milliliters or less of washing solution are left, this number is displayed in red.

2

Temperatures measured by the analyzer

6

Availability expressed in % before the next maintenance**

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B

Description of the software screens

Description of the items in figure 27 3

Level detection management*

4

Timers:

7

General information: STA Compact Max® software version number

- Operating: number of hours of operation of the analyzer since the last service call - Cumulative total: number of hours of operation of the analyzer since it was installed *Level detection The needles always detect the level of the liquid. The user can choose not to be informed in the event of a problem, except for needle 1 of analyzers equipped with the piercing option. Enabled: An error message informs the operator of level detection problems. Disabled: The operator is not warned when liquids are not detected.  All the results have an alarm code indicating that the level detection is not enabled. The operator can change the options of the level detection from Enabled to Disabled and vice versa (see 7.1.2.1 and see 7.1.2.2). **Availability before maintenance When the availability reaches 0, a message warns the operator. If the maintenance is not performed, the number becomes negative and is displayed in red. When the value of the Pipettor field is 0: -

Each result has an alarm showing that the syringe has not been maintained.

-

The Teflon tip of the syringe must be replaced.

When the value of the Light source field is 0: -

The results do not have an alarm because the light intensity of the lamp is controlled permanently.

-

The photometry lamp should be replaced for preventive purposes.

No piercing kit: the analyzer is not equipped with the cap piercing option. Number of piercings: only for analyzers equipped with the piercing option. Number of piercing operations before replacing the piercing needle 1. See also: Icons, pictograms, status and alarms System

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B

Description of the software screens

B.11.2

Settings 1 screen

Fig. 28 - Settings 1 screen

Description of the items in figure 28 1

Date when the System - Settings screens were last saved

5

Definition of the headings used to describe the files (see 7.3.3)

2

Page 1 of the settings (see items 4 to 7 for more details)

6

Definition of the access codes (see 7.3.4)

3

Open page 2 of the settings (see B.11.3)

7

Definition of the arbitrary units (see 7.3.5)

4

Definition of the content of the two header lines that appear on Normal printouts (see 7.3.3)

See also: Icons, pictograms, status and alarms System

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B

Description of the software screens

B.11.3

Settings 2 screen

Fig. 29 - Settings 2 screen

Description of the items in figure 29 1

Open page 1 of the settings (see B.11.2)

4

Barcode reader settings (see 7.3.8)

2

Page 2 of the settings (see items 3 to 6 for more details)

5

Miscellaneous: - Identifier of the default cleaner (see 7.3.9) - Audible alarm settings (see 7.3.10)

3

Communication settings (ASTM protocol) (see 7.3.7)

See also: Icons, pictograms, status and alarms System

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6

Definition of the time and date display format (see 7.3.11)

REFERENCE MANUAL

B

Description of the software screens

B.12

Description of the Maintenance screens Main screen of the User maintenance menu, see B.12.1 Maintenance screen, see B.12.2

B.12.1

Main screen of the User maintenance menu

Fig. 30 - Main screen of the User maintenance menu

Description of the items in figure 30 1

Rinsing (see 8.6.1). This program has two options:

6

Printer (see 8.6.6). This program is used to check: - the printer connection

- Clean the piercing needle (only for analyzers equipped with the piercing option) for preventive maintenance purposes.

- the printout of texts or graphics

- Check the rinsing volume to check that the "Valcor" pump and the needle level detection are working properly. 2

Maintenance (see 8.6.2 and B.12.2)

7

Barcode reader (see 8.6.7). This program is used to test the barcode reader and make sure that the codes read are those expected.

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B

Description of the software screens

Description of the items in figure 30 3

Save (see 8.6.3). This program is used to save or reread the following settings:

8

Host computer communications (see 8.6.8). This program is used to check the connection between the host computer and the analyzer.

- Configuration of the methodologies - System settings - Error messages 4

Error history. (see 8.6.4). This program displays error messages of the day

9

Data update (see 8.6.9). This program updates the data relating to conditioning modifications.

5

Photometric graphic (see 8.6.5). This program displays the photometric graphs.

10

Utilities (see 8.6.10). The TDEX utility is used to save patient data on a CD, a DVD or a USB key.

See also: Icons, pictograms, status and alarms Maintenance

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B

Description of the software screens

B.12.2

Maintenance screen

Fig. 31 - Maintenance menu

Description of the items in figure 31 1

Needle purge (see 8.5.8). This program purges the fluidics circuit to eliminate air bubbles from the tubes.

4

Replace suction tip (see 8.5.4 and see 8.3.6.3). This program is used to replace the suction tip.

2

Replace needle (see 8.5.3). This program is used to replace a pipettor needle.

5

Replace photometry lamp (see 8.5.5.1 and see 8.5.5.2).

3

Replace syringe tip/syringe (see 8.4.3 and see 8.5.9). This program is used to replace:

6

Dates of last maintenance. This program shows the time and date of the last maintenance operations.

- the Teflon tip and the O-ring of the syringe - the syringe See also: Icons, pictograms, status and alarms Maintenance

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B

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Description of the software screens

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C

Glossary

C

Glossary adapter A device used to hold the microcontainers in the samples drawer and the microcups in the product drawer. Also called a reducer. stirring Some reagents contain deposits of particles and must be stirred. Magnets are placed in the vials of reagents to be stirred. The vials are then loaded in special positions, where stirrer motors intermittently shake the magnet and, therefore, stir the reagent. needle The analyzer has three needles: - Needle n°1 is for sample, control and calibration plasmas only. - Needle n°2 is for reagents to be distributed before the first incubation only. - Needle n°3 is for reagents to be distributed after the first incubation and pre-heats the start reagent. Arm needle #2

cuvette loader The cuvettes are loaded into the analyzer in rolls of 1,000. The cuvettes are distributed one by one by a shuttle in the cuvette loader station. This shuttle is then transferred to the incubation/measurement station. aspiration Pipetting of plasma/product by the needle. Synonym: pipetting ASTM Communication protocol used to transfer information between the analyzer and a PC. auto-incrementation Automatic incrementing of identities. autozero Automatic search for the zero position of the axes. VKA Vitamin K Antagonists. magnetic stirring bar Magnetic bars are used to evenly mix the reagents.

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C

Glossary

The products are stirred by placing a magnetic bar in the vial. A motor produces a rotating magnetic field that makes the bar spin. See also "Stirring". used liquid container A container that collects the used liquid of the analyzer. Once empty, the STA® Cleaner container is reused as a used liquid container. ball A small metal ball in the bottom of each cuvette that is used for chronometry measurements. The chronometry measurement consists in measuring the variations of the amplitude of oscillation of the ball using electromagnetic sensors. Amplitude of the ball oscillation during the clotting process 1. Amplitude of the ball oscillation 2. Detection of the clotting process

incubation measurement block The part of the analyzer where the cuvettes are positioned for the incubation and measurement phases. cuvette roll A consumable made up of a film, on which 1,000 cuvettes are inserted. Identification by barcode is requested when the roll is loaded in order to keep track of the rolls. drive coil When performing chronometry measurements, the drive coils allow the ball in the cuvette to move in a pendulum-like manner. The reduction in amplitude over time means that the viscosity is gradually increasing. This increase in the viscosity corresponds to a clotting phenomenon. Physical principle of the measurement system 1. Emitting measurement coil 2. Receiver measurement coil 3. Drive coils 4. Ball 5. Cuvette

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C

Glossary

cap Tube or vial cap. If the analyzer is equipped with the cap piercing option, then analyses can be made on capped tubes. Examples of caps used on sample tubes

clot A small, clotted mass of blood or plasma. calibrator Certified sample used to deliver a known value. The value of the sample is used to calibrate the measuring system. calibration Calibration consists in measuring the settings of a methodology that defines a curve, for a given lot or reagent (or a combination of reagent lots), on the basis of the expected result of a calibrator sample. Calibration allows to determine the value of a result on the basis of a raw measured value: - time - OD/Min mapping All of the actions taken to memorize the geographical coordinates of certain characteristic points of the analyzer. Mapping can be considered as a form of programming the analyzer in order to calculate the movements to be made in order to sample a product. In order to have reliable points of reference, special tools (mapping plots) are placed in predetermined positions by the software or in a mapping hole that serves this purpose. one hundred per cent (100%) Raw measurement value, for which the concentration equals 100%. For pre-calibrated methodologies, this value is calculated by interpolation of the 100 concentration value on the calibration curve. workload All of the tasks to be completed by the analyzer. loading Loading of the products, samples or disposables in the analyzer. chronometry Measurement of the clotting time.

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C

Glossary

access code Depending on the user profile, an access code may be necessary to use some functions of the analyzer. correlation coefficient Measurement of the correlation (degree of similarity) between two or more random variables. The correlation coefficient measures the quality of the linear relation between two variables. regression coefficient The regression coefficient is used in regression analyses to analyze the correlation between variables in order to make a prediction. coefficient of variation (CV) The coefficient of variation is a measurement of dispersion. It is obtained by dividing the standard deviation by the mean. box Refers to the reagent boxes. Reagent box

colorimetry Measurement of color. Not to be confused with photometry, which measures the intensity of light. concentration Proportion of a component present in a mixture. disposable Items required to use the analyzer that must be replaced after use. E.g.: cuvettes, microcontainers, etc. quality control (QC) Execution of an analysis on a titrated (known) sample. QCs are used to track the performance of the system. normal control Plasma collected from a population of healthy individuals (men and women), who are not taking any medication, even innocuous, and who give their blood spontaneously. offset corrector A product configured in the methodologies that corresponds to one of the calibrators of the calibration. The offset corrector is used to compensate for the deviation of the reagents and to adjust the ordinate to the origin, without changing the slope. It is only used in linear methodologies for colorimetry and immunology.

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C

Glossary

daily cumulative total The mean of the quality controls on a given day. monthly cumulative total The mean of the quality controls in a given month. cuvette (reactionary) A disposable consumable that is used to take the plasma sample to be tested on the analyzer. Reactionary cuvette

mapping cuvette A cuvette-type tool used for mapping purposes. unclog (a needle) Users may be required to unclog needles using a stylet (soft mandrel) for preventive maintenance purposes. decontamination Cleaning of items that may be biologically contaminated. delta optical density (DOD) Difference in optical density (DOD). Unit of measurement used in colorimetry and turbidimetry analyses using the 2-point method. optical density (OD) Measurement of the opacity of a medium crossed by a ray of light with a given wavelength. level detection Liquid level detection system associated with each needle. Level detection cable

duplicate analysis The determination of a result may be single or duplicate. In duplicate analyses, the analysis is performed twice in two separate cuvettes. In single analyses, the analysis is performed once in one cuvette. single determination The determination of a result may be single or duplicate.

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C

Glossary

In duplicate analyses, the analysis is performed twice in two separate cuvettes. In single analyses, the analysis is performed once in one cuvette. diluent Owen Koller buffer dilution Addition of diluents to the plasma to reduce the concentration of the plasma or of an element to be detected in the plasma. E.g.: a 1/20th solution made up of one volume of plasma and 19 volumes of diluents. OD/min Unit of measurement for colorimetry and turbidimetry analyses using the OD/min kinetic method (calculation of the kinetic slope). raw data Data collected before processing. standard deviation (SD) Measurement of the dispersion or the spread of a set of values around their mean. sample Blood sample to be analyzed with the addition of an anti-coagulant to prevent premature clotting. The sample is centrifuged to separate the plasma from the figured elements of the blood. capping The results are limited to the printout values (the pre-established upper and lower levels). thumb screw Thumb screw on the needle holder assembly. Thumb screw

clamping electrovalve (EV) Part of the fluidics circuit. The clamping electrovalve is part of the piercing option. Teflon tip A small Teflon part on all the analyzer's syringes. The Teflon tips allow for optimal pipetting with each needle, while avoiding leaks.

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C

Glossary

ethanol Product used to clean certain areas or parts of the analyzer for maintenance purposes. cap piercing foot Part used to hold the tube when raising the piercing needle. cap piercing foot

extrapolation Estimate or calculation of a variable outside the range of variation of the observed values. Extrapolation is only possible with representative samples. Therefore, it demands a series of sufficiently representative observed values. front panel The Plexiglass front cover of the analyzer that can be raised in order to access the needles, the rinsing wells and the measuring plate. conversion factor A parameter defined in the methodologies. It is used for conversions between the main and secondary units. stability expiry End of a product period of conservation. vial A small glass bottle containing a product used in the analyses. hyperbolic (mode) A graphic calibration mode that takes the form Y = a+b / (x - N). automatic identification Automatic identification of a product by reading the barcode on the vial/tube. manual identification Identification of a product or sample by typing the information required for loading purposes. positive identification (of positions) A system used by the analyzer to automatically detect the position in which a tube or vial has been loaded. incubation A physical action (by heat exchange) that brings the product in a cuvette to the required temperature. The time required for a mixture to reach the temperature of the medium and/or to develop a given reaction. INR International Normalized Ratio. A standard means of expressing the prothrombin time (PT) that corrects the variations due to the various thromboplastins used by medical laboratories.

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C

Glossary

The INR is defined by the following formula: INR = (patient's PT/MNPT)ISI MNPT: Mean Normal Prothrombin Time See also prothrombin time. interpolation Approximate estimate of the intermediate values in a series of known values. ISI (International Sensitivity Index) An index that is specific to the diagnosis of thromboplastin. It is used to calculate results expressed in INR. O-ring Seals used on the analyzer to seal the fluidics circuit. O-ring

K (vitamin) Anti-hemorrhagic vitamin that is essential to the hepatic biosynthesis of numerous plasmatic factors of clotting process. printout limits The maximum and minimum limits defined by the user in the Methodologies menu. They represent a range of values, beyond which the results are automatically capped. validation range The minimum and maximum limits defined by the user in the Validation section of the Methodologies menu. They represent the range of permissible values for the selected methodology. linear (mode) A graphic calibration mode that takes the form Y=ax+b. incident light The light falling on an object or surface. stray light Light from a foreign source that deteriorates the quality of the data to be examined. goggles Eye shields that may have to be worn in certain operations, in which the operator may come into contact with products that are potentially biologically contaminated. mandrel (stylet) A thin nylon rod used to unblock (unclog) standard needles. Stylets must never be used on the piercing needles. methodology A procedure used to conduct an analysis. A methodology consists of a number of tasks: pipetting, dilution, addition of reagents, incubation, measurement.

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Glossary

These tasks are completed by secondary tasks: cuvette loading, transfers, rinsing, etc. microcontainer Used to load small volumes of samples. Microcontainer

microcup Used to load small volumes of reagents. Microcup

shuttle The shuttle transfers the cuvettes into the analyzer. control level (quality) Used in quality controls. There can be up to three control levels. Level 1 usually represents normal plasma samples. Level 2 represents samples of pathological plasma. package insert Insert provided with the reagent boxes, including the instructions and precautions. lot number The lot number of the product or reagent is shown in the product insert. assay value insert A sheet containing the barcodes used when loading products belonging to a new lot (e.g., pre-calibrations, quality controls, etc.). The inserts include the pre-established data (lot number, box reference, reagent reference, expiry date, etc.) that is entered into the system by reading the barcodes on the sheet. parity (none, even or odd) A parameter used in communications with the host computer (ASTM protocol). The types of parity are "none", "even" or "odd".

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Glossary

photometry Measurement of the light intensity. Not to be confused with Colorimetry, which consists in measuring color. pipetting Aspiration. pipettor A component in the fluidics circuit that samples and distributes liquids. piston (of the syringe) The piston in the Hamilton syringe. Syringe piston

plasma A clear liquid obtained by centrifuging blood. measurement plate The part of the analyzer containing the measuring block. "Valcor" pump A component of the fluidics circuit that works with the electrovalves to generate the needle rinsing cycles. prefix The prefix can be used to differentiate the different populations of samples according to criteria chosen by the laboratory E.g., "POP" = prefix for pre-operation, "HEP" = prefix for patients taking Heparin. Standardized Operating Procedures A manual containing the methodologies for each analyzer. product The term "product" refers to controls, calibrators, reagents, diluents (Owren Koller buffers) and cleaners.

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C

Glossary

automatic profile A profile select from the list of pre-recorded profiles that is automatically applied to one or more given samples. needle protection A soft tube that covers the piercing needle in order to protect the user's hands whenever they come close to the needle. tube protector (of the clamping electrovalve) A small, rigid plastic cylinder, that can be repositioned, and is placed around the clamping electrovalve to prevent the pipe from coming out of the clamping electrovalve. rinsing well The well in which the needles of the analyzer are washed. purge (needle) Cleaning the needles. QNS (Insufficient plasma volume) A measurement error indicating that the needle has not detected any plasma in the tube. Ra, Rb, Rc, Rd Reagents A, B, C and D. Abbreviations indicating the order in which the reagents are added in a measurement sequence. transmission rank Information entered by the user in the methodologies for the transmission of the results to the host computer. reagent Any chemical or biological substance specially prepared for in vitro use, either alone or in association, in medical biology analyses. start reagent Measurement begins when the start reagent is distributed in the cuvette. Abbreviation: Rd redilution Redilution consists in performing the same measurement with the same methodology, on the same sample (patient, QC), but with a ratio of dilution that is different from the ratio that has just been used to produce a result or an error.

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Glossary

reducer (Mini or Maxi) A cylinder placed in the bottom of a vial to prevent the product from evaporating and the minimum volume (dead volume) from being reduced. For medium-volume reagents (STA® -Mini Reducer) or high-volume reagents (STA® -Maxi Reducer). STA® -Mini Reducer and STA® -Maxi Reducer

linear regression Linear regression is used to study and measure the mathematical relation between two quantitative variables. rerun Reruns consist in performing the same measurement with the same methodology, on the same sample (patient, QC or calibrator), with the same dilution that has just produced a result or an error. automatic rerun The system performs automatic reruns, in particular when: - the incubation time of an analysis is exceeded - the result of an analysis or control is outside the defined thresholds intermediate reservoir A component of the fluidics circuit containing the STA® Cleaner. Intermediate reservoir

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C

Glossary

Hamilton syringe The Hamilton syringe is used to convey the STA® Cleaner in the fluidics circuit. Hamilton syringe

LIS (Laboratory Information System) A computer system capable of communicating directly or indirectly with the analyzer using the ASTM protocol. decontaminating solution A bleach-based solution used to decontaminate various parts of the analyzer. cuvette loading station Transfers the cuvettes to the shuttle. STA® Cleaner Washing solution. STA® Desorb U Decontaminating solution. test panel The Test panel is used in particular to keep track of the analyses of the tubes on board the analyzer in real time. Owen Koller buffer A diluent used for clotting assay purposes. dilution ratio The proportion to which a sample must be diluted. This ratio is specified in the methodologies. TDEX A utility used to export patient data. Prothrombin time (PT) Clotting time of patient’s plasma measured in the presence of calcium and of an excess of tissue (factor) thromboplastin. The prothrombin time primary use is to explore the extrinsic pathway of coagulation (factors II, V, VII , X and fibrinogen).

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Glossary

suction head Part of the suction system. Suction head

trace Record of the execution of an operation or a series of operations. frame (ASTM) The format required to transmit data. transmission (online) Transmission of data between the analyzer and the host computer. heating tube A tube used to preheat the sampled start reagents to 37°C. arbitrary unit The laboratory can create up to three arbitrary units for internal purposes. These units can be used as primary or secondary units. raw unit The unit in which the result of the physical measurement is calculated and expressed. The analyzers use the following raw units: - seconds - OD/min - DOD primary unit The unit in which the biological result of the analysis is calculated and expressed. The result in primary units is calculated on the basis of the result in raw units, using the calibration characteristics of the reagent used. The system proposes a selection of predefined primary units. The primary unit is compulsory, while secondary units are optional. secondary unit An optional unit used to express the result. acceptance values The minimum and maximum values defined by the user in the methodologies. They represent the ranges of acceptable values of any result expressed in the primary unit.

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Glossary

suction tip A component of the suction system. Suction tips

measurement channel The path along which the information on the measurement is sent. minimum volume (dead volume) The minimum volume in a vial, below which the analyzer can no longer sample the product. In this case, the analyzer can no longer use the vial.

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Glossary

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