Sigma Amelung KC4 Delta User manual

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COAGULATION

ANALYZER

OPERATION MANUAL

Instrument manufactured by

Sigma Amelung,

Lemgo, Germany

REVISION DATE 10/23/01

SIGMA DIAGNOSTICS INSTRUMENT WARRANTY

Sigma-Aldrich Co., Inc. ("Sigma"), warrants that instruments it sells to be free from defects in workmanship and materials during normal use by the original purchaser.

This Warranty shall continue for a period of one year from the date of invoice to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the "Warranty Period").

If any defects occur during the Warranty Period, contact the Sigma Service Center immediately, and be prepared to furnish pertinent details concerning the defect, the model number, and the serial number.

Warranty service is provided 8:30 a.m. through 5:00 p.m., Monday through Friday, except on Sigma observed holidays. Any service performed at other times, and all service required to correct defects or malfunctions not covered by this Warranty, will be billed on a time-and-material basis at Sigma's labor rates then in effect.

This Warranty does not cover defects or malfunctions which: (1) are not reported to Sigma during the Warranty Period and within one week of occurrence; (2) result from chemical decomposition or corrosion; (3) are described in the applicable Sigma Operation Guide; (4) result from maintenance, repair, or modification performed without Sigma's prior written authorization; or (5) result from misuse, abuse or accident.

Sigma's liability for all matters arising from the supply, installation, use, repair, and maintenance of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Sigma's sole discretion) replacement of the instrument or of components thereof. In no event shall Sigma be liable for injuries sustained by third parties, incidental or consequential damages, or lost profits.

Replaced parts shall become the property of Sigma.

THE FOREGOING IS THE SOLE WARRANTY MADE BY SIGMA REGARDING THE INSTRUMENT, AND SIGMA SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.

KC4

(Software Version 1.1B)

October 2001 EN

™ User Manual, October 2001

∆

KC4 ∆∆∆∆™

Table of Contents

1 INTRODUCTION.................................................................................................... 1-1

1.1 INTENDED USE ................................................................................................. 1-1

1.2 PRINCIPLES OF OPERATION.............................................................................. 1-1

1.3 PHYSICAL SPECIFICATIONS .............................................................................. 1-2

1.4 PERFORMANCE SPECIFICATIONS ..................................................................... 1-3

1.5 PHYSICAL DESCRIPTION ................................................................................... 1-6

1.6 FRONT VIEW (FIGURE 1) ................................................................................... 1-7

1.7 KEYPAD (FIGURE 2)........................................................................................... 1-8

1.8 BACK VIEW (FIGURE 3) ..................................................................................... 1-9

1.9 MULTIPETTE (FIGURE 4 A & B) ....................................................................... 1-10

1.10 BALL DISPENSER (FIGURE 5) .......................................................................... 1-11

1.11 THERMAL PRINTER (FIGURE 6) ....................................................................... 1-11

1.12 PRINTER OPTIONS........................................................................................... 1-12

2 INSTALLATION ..................................................................................................... 2-1

2.1 UNPACKING ....................................................................................................... 2-1

2.2 KC4 ∆™ COAGULATION ANALYZER START-UP KIT............................................ 2-1

2.3 LOCATION REQUIREMENTS .............................................................................. 2-2

2.4 ELECTRICAL REQUIREMENTS .......................................................................... 2-2

2.5 PRELIMINARY CHECK OF THE INSTRUMENT OPERATION ................................ 2-3

3 GENERAL OPERATION ......................................................................................... 3-1

3.1 INSTRUMENT PREPARATION ............................................................................. 3-1

3.2 TEMPERATURE INDICATOR SCREEN ................................................................ 3-1

3.3 MAIN MENU FUNCTIONS ................................................................................... 3-2

3.4 PASSWORD MODIFICATION .............................................................................. 3-2

3.5 PROGRAM MODIFICATION ................................................................................ 3-3

3.6 REAGENT HANDLING ........................................................................................ 3-4

3.7 CUVETTE PREPARATION ................................................................................... 3-4

3.8 SAMPLE PREPARATION ..................................................................................... 3-5

3.9 PIPETTING ......................................................................................................... 3-6

3.10 TO DISPENSE SAMPLE ...................................................................................... 3-7

3.11 TO DISPENSE FIRST REAGENT ......................................................................... 3-8

3.12 TO DISPENSE START REAGENT ........................................................................ 3-9

3.13 SELECTING A TEST TO BEGIN A RUN ............................................................. 3-10

3.14 PATIENT IDENTIFICATION ............................................................................... 3-11

3.15 TESTING .......................................................................................................... 3-11

3.16 MANUAL START PROCEDURE ......................................................................... 3-12

3.17 AUTOMATIC START PROCEDURE.................................................................... 3-12

3.18 PRINTING RESULTS ......................................................................................... 3-13

4 MODE PROGRAMMING ......................................................................................... 4-1

4.1 ROUTINE PROGRAMMING ................................................................................. 4-1

4.2 EMERGENCY PROGRAMMING ........................................................................... 4-2

4.3 INDIVIDUAL PROGRAMMING............................................................................. 4-3

October 2001 TOC-1 EN

KC4 ∆∆∆∆™

Table of Contents

5 TEST PROGRAMMING........................................................................................... 5-1

5.1 INR .................................................................................................................... 5-1

5.2 INR FLOW CHART.............................................................................................. 5-3

5.3 PROTHROMBIN TIME (PERCENT ACTIVITY CURVE) .......................................... 5-4

5.4 PT (PERCENT ACTIVITY) FLOW CHART.............................................................. 5-7

5.5 RATIO FLOW CHART ......................................................................................... 5-8

5.6 ACTIVATED PARTIAL THROMBOPLASTIN TIME................................................. 5-9

5.7 APTT FLOW CHART ......................................................................................... 5-11

5.8 FIBRINOGEN ................................................................................................... 5-12

5.9 FIBRINOGEN FLOW CHART............................................................................. 5-15

5.10 FACTORS......................................................................................................... 5-16

5.11 FACTORS FLOW CHART .................................................................................. 5-19

5.12 STATS.............................................................................................................. 5-20

6 QUALITY CONTROL .............................................................................................. 6-1

7 MAINTENANCE ..................................................................................................... 7-1

8 TROUBLESHOOTING............................................................................................. 8-1

8.1 TROUBLESHOOTING FLOW DIAGRAM .............................................................. 8-1

8.2 TROUBLESHOOTING PROCEDURES TABLE...................................................... 8-1

A APPENDIX ............................................................................................................ A-1

A.1 INR FAST TRACK ............................................................................................... A-1

A.2 APTT FAST TRACK............................................................................................. A-2

A.3 FIBRINOGEN FAST TRACK ................................................................................ A-3

A.4 FIBRINOGEN CALIBRATION CURVE DILUTION ................................................. A-4

A.5 EXTRINSIC FACTORS II, V, VII AND X FAST TRACK .......................................... A-5

A.6 EXTRINSIC FACTOR STANDARD CURVE DILUTIONS ........................................ A-6

A.7 INTRINSIC FACTORS VIII, IX, XI AND XII FAST TRACK...................................... A-7

A.8 INTRINSIC FACTOR STANDARD CURVE DILUTIONS ......................................... A-8

TOC-2 EN October 2001

KC4 ∆∆∆∆™

Introduction

1Introduction

Contents

1.1 INTENDED USE...................................................................................... 1-1

1.2 PRINCIPLES OF OPERATION.................................................................. 1-1

1.3 PHYSICAL SPECIFICATIONS .................................................................. 1-2

1.4 PERFORMANCE SPECIFICATIONS ......................................................... 1-3

1.5 PHYSICAL DESCRIPTION ....................................................................... 1-6

1.6 FRONT VIEW (FIGURE 1) ....................................................................... 1-7

1.7 KEYPAD (FIGURE 2)............................................................................... 1-8

1.8 BACK VIEW (FIGURE 3).......................................................................... 1-9

1.9 MULTIPETTE (FIGURE 4 A & B).............................................................1-10

1.10 BALL DISPENSER (FIGURE 5)............................................................... 1-11

1.11 THERMAL PRINTER (FIGURE 6)........................................................... 1-11

1.12 PRINTER OPTIONS ...............................................................................1-12

October 2001 1-0 EN

KC4 ∆∆∆∆™

Introduction

1.1 Intended Use

The KC4∆™ Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations determined by Clauss methodology, and other clotting assays. Any clotting based assay, which has fibrin formation as its endpoint may be performed on the KC4 Measurement can be qualitative or quantitative. When used in conjunction with appropriate reagents, the sample can be plasma, or whole blood.

The additions of both sample and reagents are manual. Time measurement of the clotting endpoint is automated.

1.2 Principles of Operation

The KC4∆™ is an electromechanical clot detection system. The system utilizes a special cuvette in which there is a stainless steel ball. Sample is added to the cuvette. After an appropriate incubation period, the cuvette is placed into the measuring well of

∆

the KC4 along its longitudinal axis. Because the cuvette is positioned at a slight angle, gravity and inertia always position the ball at the lowest point of the cuvette. Exactly opposite the ball-position is a magnetic sensor. With the addition of appropriate reagent, a timer is started. As coagulation takes place, fibrin strands form in the reaction mixture. The fibrin strands pull the ball away from its position and triggers an impulse in the magnetic sensor. This impulse electronically stops the timer (see diagrams).

™. The measuring well rotates slowly (50 rpm) causing the cuvette to rotate

∆

™ Coagulation Analyzer.

October 2001 1-1 EN

Introduction

1.3 Physical Specifications

Type: Coagulation Analyzer, Bench Top

Online: Unidirectional

Principle: Ball Method

Measuring Channels: 4

Display: LCD

Incubation Wells: 8

Reagent Wells: 5

Dimensions

Height: 12.0 cm

Width: 35.4 cm

KC4 ∆∆∆∆™

Depth: 45.0 cm

Weight 6.3 kg

Power Supply

Voltage 110–220V/50–60 HZ

Power Consumption 1.5A at 100V; 0.4A at 220V

Temperature Control

Reagent Warming Wells: 37.0°C ± 0.5°C

Reaction Incubation Wells: 37.0°C ± 0.5°C

Measurement Wells: 37.0°C ± 0.5°C

Measurement Time

Minimum: 4.5 seconds

Maximum: 999.9 seconds

1-2 EN October 2001

KC4 ∆∆∆∆™

Introduction

1.4 Performance Specifications

The overall performance of any testing performed on the KC4∆™ Coagulation Analyzer is dependent not only on the instrument performance, but is also a function of specimen integrity (collection and handling) as well as accuracy and precision of the sample and reagent dispensing system being used.

Correlation:

The following linear regression data was obtained during evaluation to show equivalence with a commercially available mechanical coagulation analyzer.

Activated Partial

Prothrombin Time

Number of Samples 121 110 Correlation Coefficient (r) 0.998 0.896 Slope 1.051 1.235 Intercept –0.241 0.873

Thromboplastin Time

The following linear regression data was obtained during evaluation to show equivalence with a commercially available photo-optical coagulation analyzer.

Fibrinogen Factor X Factor IX

Number of Samples 109 112 101 Correlation Coefficient (r) 0.930 0.974 0.897 Slope 1.067 1.010 0.958 Intercept 30.749 –0.166 3.403

The following linear regression data was obtained in three physician’s office laboratories (POL) during evaluation to show equivalence with manufacturer derived results on the

∆

KC4

™ Coagulation Analyzer.

Activated Partial

POL #1 Prothrombin Time

Number of Samples 47 44 Correlation Coefficient (r) 0.991 0.960 Slope 0.981 1.066 Intercept 0.492 0.379

Thromboplastin Time

Activated Partial

POL #2 Prothrombin Time

Number of Samples 45 46 Correlation Coefficient (r) 0.989 0.965 Slope 1.019 1.029 Intercept –0.248 1.021

October 2001 1-3 EN

Thromboplastin Time

KC4 ∆∆∆∆™

Introduction

Activated Partial

POL #3 Prothrombin Time

Number of Samples 52 47 Correlation Coefficient (r) 0.974 0.927 Slope 1.012 0.786 Intercept 0.326 9.470

Precision: Prothrombin Time (PT)

Imprecision was evaluated at three levels according to the NCCLS EP5-T2 protocol.

Low Mid High

Mean (seconds) 13.20 33.53 39.66 Total Imprecision (CV%) 2.03 2.50 4.18 Within-Run Imprecision (CV%) 1.02 1.28 1.53

PT total imprecision was evaluated in three physician’s office laboratories (POL) at three levels according to NCCLS EP10-T protocol. Within-Run imprecision was evaluated in three physician’s office laboratories at two levels.

Thromboplastin Time

POL #1 Low Mid High

Mean (seconds) 13.1 26.8 42.9 Total Imprecision (CV%) 1.97 1.63 2.47

Mean (seconds) 12.7 44.1 Within-Run Imprecision (CV%) 1.3 1.1

POL #2 Low Mid High

Mean (seconds) 12.1 23.3 40.7 Total Imprecision (CV%) 2.59 7.12 3.0

Mean (seconds) 12.1 41.7 Within-Run Imprecision (CV%) 2.6 1.8

POL #3 Low Mid High

Mean (seconds) 11.3 22.8 34.2 Total Imprecision (CV%) 1.57 7.41 0.50

Mean (seconds) 11.4 34.7 Within-Run Imprecision (CV%) 2.0 1.3

1-4 EN October 2001

KC4 ∆∆∆∆™

Introduction

Precision: Activated Partial Thromboplastin Time (APTT)

Imprecision was evaluated at three levels according to the EP5-T2 protocol.

Low Mid High

Mean (seconds) 28.55 51.01 75.78 Total Imprecision (CV%) 3.12 3.41 3.21 Within-Run Imprecision (CV%) 1.47 1.60 1.37

APTT total imprecision was evaluated in three physician’s office laboratories (POL) at three levels according to NCCLS EP10-T protocol. Within-Run imprecision was evaluated in three physician’s office laboratories at two levels.

POL #1 Low Mid High

Mean (seconds) 29.0 43.3 57.6 Total Imprecision (CV%) 2.83 3.15 1.87

Mean (seconds) 30.8 57.5 Within-Run Imprecision (CV%) 2.7 1.6

POL #2 Low Mid High

Mean (seconds) 29.2 42.7 57.0 Total Imprecision (CV%) 4.38 2.29 2.84

Mean (seconds) 28.2 57.1 Within-Run Imprecision (CV%) 2.1 1.7

POL #3 Low Mid High

Mean (seconds) 30.0 54.7 68.6 Total Imprecision (CV%) 1.87 1.80 2.13

Mean (seconds) 26.9 64.4 Within-Run Imprecision (CV%) 1.4 2.5

Precision: Fibrinogen

Imprecision was evaluated at three levels according to the NCCLS EP5-T2 protocol.

Low Mid High

Mean (mg/dl) 104.09 154.10 323.53 Total Imprecision (CV%) 3.53 6.21 4.36 Within-Run Imprecision (CV%) 2.05 2.86 2.12

October 2001 1-5 EN

KC4 ∆∆∆∆™

Introduction

Precision: Factor X

Imprecision was evaluated at three levels according to the NCCLS EP5-T2 protocol.

Low Mid High

Mean (%) 31 57 102 Total Imprecision (CV%) 8.28 5.71 5.22 Within-Run Imprecision (CV%) 2.63 2.22 2.20

Precision: Factor IX

Imprecision was evaluated at three levels according to the NCCLS EP5-T2 protocol.

Low Mid High

Mean (%) 24 49 98 Total Imprecision (CV%) 5.88 6.89 4.06 Within-Run Imprecision (CV%) 3.96 4.04 2.54

1.5 Physical Description

The external features of the KC4∆™ Coagulation Analyzer are shown in Figure 1 (Front), Figure 2 (Keypad), Figure 3 (Rear), Figure 4 (Automatic Multipette with starter cable), Figure 5 (Ball Dispenser) and Figure 6 (Thermal Printer).

1-6 EN October 2001

KC4 ∆∆∆∆™

Introduction

1.6 Front View (Figure 1)

Item Function or Description

1. Rack Used for transferring cuvettes from preparation area to reaction incubation wells and rotating test positions.

2. Preparation Area Room temperature wells used for sample preparation prior to incubation.

3. Pipette Tubes Used to store the pipettes when not in use.

4. Reagent Warming Wells (5) Three 15 mm, and two 11 mm heated wells used to warm reagents.

5. Reaction Incubation Wells (8) Heated wells used for incubation of sample and first reagent.

6. Rotating Test Positions (4) Positions where start reagent is added and the clotting time is measured.

7. Display Screen Displays elapsed time in seconds during incubation for each of 4 channels. Displays elapsed time in seconds and tenths of seconds during clot time measurement. Displays incubation times, clotting times, programming selections and other menus.

October 2001 1-7 EN

KC4 ∆∆∆∆™

Introduction

1.7 Keypad (Figure 2)

12 3 4 4 4 45

Item Function or Description

1. Start Key Activates automatic measurement timer.

2. Incubation Key Starts Incubation timers.

3. Ready Key Not functional at this time.

4. Channel Key Starts manual timing and incubation.

5. Stop Key Terminates measurements, and aborts

testing.

6. Function Keys Used in programming tests.

7. Menu Key Returns to Main Menu from Operating

Screen.

8. Run Key Returns to Test Program Selection Screen from Operating Screen.

↵↵↵↵

10. ESC Key Escapes back to previous function

11. Printer Key Used to turn printer on or off

ENTER

12. Dilution Key Used to change the patient dilution.

13. DEL key

1-8 EN October 2001

KC4 ∆∆∆∆™

Introduction

1.8 Back View (Figure 3)

2. 1.

Item Function or Description

1. Thermal Printer Port Thermal Printer connection.

2. Automatic Multipette Socket(s) Used to connect pipettes (Remove the capplug in the Multipette).

3. Power Switch Powers instrument off/on.

4. Power Supply Socket Connects instrument to power cord.

October 2001 1-9 EN

KC4 ∆∆∆∆™

Introduction

1.9 Multipette (Figure 4 A & B)

Combitip

4-A

Item 4-B Function or Description

1. Volume selection dial Determines pipetting volume: setting (1–5) multiplied by the minimum pipetting volume of the Combitip (1.25 ml or 2.50 ml pipette tips).

Multipette

4-B

2. Pipetting lever The volume is pipetted by pressing the pipetting lever down until it stops.

3. Filling lever The Combitip is filled by sliding this lever upward.

4. Locking clamp The locking clamp serves to firmly clamp the Combitip.

5. Combitip The pipette tip used with the automatic multipette.

6. Combitip Cone Portion of the pipette tip that aspirates reagent.

7. Starter Cable Connects pipette to instrument.

1-10 EN October 2001

KC4 ∆∆∆∆™

Introduction

1.10 Ball Dispenser (Figure 5)

Item Description or Function

1. Dispenser For loading microballs into cuvettes

1.11 Thermal Printer (Figure 6)

October 2001 1-11 EN

1.12 Printer Options

KC4 ∆∆∆∆™

Introduction

From the Main Menu, press < options have been selected. If the analyzer is connected to a host LIS, ensure that option 4

is selected. If the analyzer is not connected to a host LIS, select 5.

↵↵↵↵

>. Press the <PRINTER> key. The (*) shows which

Print Test Page 1

Print Switch On 2*

Print Switch Off 3

Line - out incl. Error Val. 4*

Line - out excl. Error Val. 5

Press ENTER <

> to continue

↵↵↵↵

1-12 EN October 2001

KC4 ∆∆∆∆™

Installation

2Installation

Contents

2.1 UNPACKING........................................................................................... 2-1

2.2 KC4

2.3 LOCATION REQUIREMENTS................................................................... 2-2

2.4 ELECTRICAL REQUIREMENTS............................................................... 2-2

2.5 PRELIMINARY CHECK OF THE INSTRUMENT OPERATION..................... 2-3

∆∆∆∆

™ COAGULATION ANALYZER START-UP KIT ................................ 2-1

October 2001 2-0 EN

KC4 ∆∆∆∆™

Installation

2.1 Unpacking

The KC4 instrument from damage during shipment. If damage is apparent, immediately notify the shipping company. Note the damage on the shipping bill of lading and notify your Sigma Diagnostics Sales Representative.

2.2 KC4

Carefully remove the instrument and accessories from the transport box. Check that the following items have been included:

KC4

∆∆∆∆

™ Coagulation Analyzer is shipped in a transport box designed to protect the

∆∆∆∆

™ Coagulation Analyzer Start-Up Kit

∆∆∆∆

™ Coagulation Analyzer

1. Power Cable

2. KC Micro Tetravettes

3. KC Delta Multipette with Starter Cable and Adapter Cord

4. Combitips (1.25 ml); 5 each

5. KC Pipette Tips, Yellow 200

6. Tubes, Plastic (14.5 x 85 mm); 100 each

7. Tubes, Glass (15 x 85 mm), 50 each

8. Power Supply 12V

l; 1 tray

9. Lead for Power Supply

10. Protective Dust Cover; 1 each

Optional Items

Catalog Number Item

1. P2864 KC Series Printer with Power Adapter

2. K1638 * KC Series Thermal Printer Paper

3. K4882 KC4

4. K0508 * KC4

5. K1510 * KC4

6. K4257 * KC Pipette Tips, Yellow, 200

7. T9304 * Tubes, Glass (15 x 85 mm), 50 each

8. K4887 * KC4

9. T2242* Tubes, plastic (14.5 x 85 mm)

10. K1635* KC Micro Cuvettes with Ball Dispencer

11. A6083 Coated Stir Bar

12. K6208 APTT Stir Bar

∆

™ Multipette with Starter Cable

∆

™ Combitips 1.25 ml

∆

™ Combitips 2.50 ml

l, 10 trays

∆

™ Tetravettes

13. K0633 KC Pittette Tube Sleeves

October 2001 2-1 EN

KC4 ∆∆∆∆™

Installation

*These are consumable items and should be ordered as needed.

Pipettes are required for the test performance. Although the use of a Multipette will ensure the start of the timing measurement is simultaneous with the addition of the reagent, it is not mandatory.

Read the Operation Manual carefully prior to using the KC4 The Operation Manual has been written to provide the most comprehensive

∆

understanding of the operation of the KC4 you to fully utilize the features of the instrument.

™ Coagulation Analyzer and to enable

∆

™ Coagulation Analyzer.

2.3 Location Requirements

1. Place the KC4∆™ Coagulation Analyzer on a stable, vibration and dust free work surface. It should not be positioned next to a centrifuge or other equipment, which may cause vibration. The KC4 from moisture.

2. To avoid exceeding the control range of the instrument, place the KC4 Coagulation Analyzer in an area with a maximum room temperature of 30°C. It should not be positioned in an area directly below ventilating ducts which produce strong air currents. Do not expose the KC4 to direct sunlight. Sunlight influences the temperature control.

3. It is preferable to place the KC4 further than (6 ft.) 1.8 m from an electrical outlet. The instrument should not be operated from an extension cord which does not employ protective grounding. The electrical outlet used should not be shared with any devices, which consume large amounts of power on a cyclic basis (e.g., centrifuges, air conditioners, and refrigerators). When these type of devices cycle on and off, there may be a voltage drop in the line which could interfere with the proper functioning of the instrument.

∆

™ Coagulation Analyzer should also be protected

∆

™

∆

™ Coagulation Analyzer

∆

™ Coagulation Analyzer in an area which is no

2.4 Electrical Requirements

The KC4∆™ Coagulation Analyzer is designed with a factory equipped three-pronged grounding plug designed to be connected to the Power Supply, which is then plugged into the analyzer. Under no circumstances should it be connected to an ungrounded two-pronged receptacle. This procedure is in accordance with the National Electrical Code and other applicable ordinances for this type of installation.

1. Do not use an extension cord which cannot to provide protective grounding.

2. It is recommended that any repair work other than routine maintenance

be performed by a trained specialist familiar with the hazards involved.

3. If safe operation of the KC4

the instrument must be taken out of service.

2-2 EN October 2001

∆

™ Coagulation Analyzer is no longer possible,

KC4 ∆∆∆∆™

Installation

2.5 Preliminary Check of the Instrument Operation

The preliminary function checks of instrument operation should be performed prior to using the instrument. This preliminary function check is to ensure that the instrument is functioning properly prior to reporting patient results.

1. Connect the power cable to the power cable socket on the back of the instrument (DC6.5V 2A).

2. Connect the Data Cable from the Serial Port on the Printer to the Printer port on the back of the Analyzer if utilizing the KC4

∆

3. Activate the KC4 located on the left hand side of the back of the instrument.

4. Observe that the display screen lights up; a screen appears giving the operator the option to select the operating language. After the language selection, a screen showing a thermometer appears and will remain displayed while the instrument warms up to 37°C.

5. Observe that four of the measurement wells are rotating. The wells will rotate continuously whenever the instrument is on.

™ Coagulation Analyzer by pressing the off/on switch

∆

™ printer.

∆

6. Place a KC4 rack. Place the cuvette rack on the rotating test positions such that the cuvettes are sitting flush in the holes. If using a KC4 ball into each cuvette using the ball dispenser. Observe that the ball falls to the front of the cuvette and stays there.

7. Verification of temperature can be performed by placing approximately 3 ml of water into a 15-mm reagent tube. Place a thermometer into the tube and allow to equilibrate until the temperature has stabilized. Approximately 15 minutes will be required for temperature stabilization. The temperature should be 37° ±0.5°C.

Note: The use of smaller diameter tubes is not recommended due to inadequate

heat transfer.

8. To verify the operation of the timers, use the pipette with the start cable, and the measuring wells, a program modification is needed. From the Main Menu, select 3

9. Enter the password; default password is 1 2 3 4. Press <

10. Select 4 Press <

11. To access the program settings, press < at the top of the screen. Press 1

Program Selection.

Individual Program Modify; press TZ (Thrombin Clotting Time) key.

↵↵↵↵

™ Micro cuvette or Tetravette into each position of the cuvette

∆

™ Micro cuvette, dispense one

↵↵↵↵

>. Press 2

(Yes) to modify TZ.

(No) until “Test TZ” appears

12. Enter 1

13. Enter incubation time of 10 seconds, press < modifications are done.

14. Press < (Thrombin Clotting Time) key; press <

October 2001 2-3 EN

(duplicate testing), and 10% for allowed CV; press <

↵↵↵↵

>. Press 2

↵↵↵↵

> to continue. Press Run; select 3

Start Individual Program. Press TZ

↵↵↵↵

> to continue.

(No) when

KC4 ∆∆∆∆™

Installation

15. Enter 2 samples per rack; press < Screen up.

16. If the automatic Multipette with the starter cable is being used, plug the pipette cable connection into the pipette cable socket on the rear of the KC4 the locking mechanism on the Multipette into place.

17. Start timers by pressing the <START> key , followed by the individual well

timers . When all timers are showing 0.0, press and hold the <START>

key , while at the same time, depress the trigger switch on the Multipette 4 times. All wells should begin timing.

18. After at least 10 seconds, remove the cuvette rack from the rotating test positions. Observe that the timers stop and are indicating the elapsed time in seconds and tenths of seconds.

19. The first result will print automatically (if the optional printer has been installed), or will appear on the screen. Press < and clear the memory.

With the completion of the Preliminary Checks of Instrument Operation, installation is complete and the instrument is ready for operation. If the instrument fails to perform any of the tests with the specifications listed, call Sigma Diagnostics Technical Service for assistance.

↵↵↵↵

>. Press <

↵↵↵↵

> again to bring the Operating

∆

™. Snap

↵↵↵↵

> to print the second result,

2-4 EN October 2001

KC4 ∆∆∆∆™

General Operation

3General Operation

Contents

3.1 INSTRUMENT PREPARATION................................................................. 3-1

3.2 TEMPERATURE INDICATOR SCREEN..................................................... 3-1

3.3 MAIN MENU FUNCTIONS........................................................................ 3-2

3.4 PASSWORD MODIFICATION ................................................................... 3-2

3.5 PROGRAM MODIFICATION..................................................................... 3-3

3.6 REAGENT HANDLING............................................................................. 3-4

3.7 CUVETTE PREPARATION ....................................................................... 3-4

3.8 SAMPLE PREPARATION ......................................................................... 3-5

3.9 PIPETTING ............................................................................................ 3-6

3.10 TO DISPENSE SAMPLE........................................................................... 3-7

3.11 TO DISPENSE FIRST REAGENT.............................................................. 3-8

3.12 TO DISPENSE START REAGENT............................................................. 3-9

3.13 SELECTING A TEST TO BEGIN A RUN ...................................................3-10

3.14 PATIENT IDENTIFICATION ...................................................................3-11

3.15 TESTING...............................................................................................3-11

3.16 MANUAL START PROCEDURE ...............................................................3-12

3.17 AUTOMATIC START PROCEDURE .........................................................3-12

3.18 PRINTING RESULTS..............................................................................3-13

October 2001 3-0 EN

KC4 ∆∆∆∆™

General Operation

3.1 Instrument Preparation

The KC4∆™ is activated by the on/off button located on the back of the instrument. Turn instrument on and select appropriate language. Press <

Note: This screen will only appear the first time the analyzer is turned on. After

a language has been selected, the analyzer will automatically display the temperature indicator screen (shown below) on each subsequent power on.

Sprachwahl.

Deutsch 1

Englisch *2

Franzoesisch 3

Italienisch 4

Niederlaendisch 5

Spanisch 6

Weiter mit Taste ENTER

↵↵↵↵

3.2 Temperature Indicator Screen

In this figure, the thermometer indicates operating temperature has not been reached.

In approximately 20 minutes the analyzer will reach operating temperature (37° ±0.5°C). The display will change to the MAIN MENU:

October 2001 3-1 EN

3.3 Main Menu Functions

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

KC4 ∆∆∆∆™

General Operation

Press

to continue

↵↵↵↵

1. To enter DATE, select 1. The date is in European format: dd,mm,yy. 12-09-2001 is September 12, 2001. The entry is confirmed with < terminated with <ESC>. If terminated, the previous values remain valid.

2. To enter TIME, select 2

3. To modify Program Selection, select 3

. The format for time is hh:mm; example: 10:08

4. To PRINT a copy of all programmed tests and parameters, select 4

5. To proceed to the Operating Screen, press <

↵↵↵↵

3.4 Password Modification

From the Main Menu screen, press 3 Program Selection.

Password modify 1

Routine Program modify 2

Emergency Program modify 3

Individual Program modify 4

Delete all programs 5

Language modify 6

Press

Parameter Check with Enter

to continue

↵↵↵↵

> or

Select 1

, Password modify. Enter a new password, Press <

↵↵↵↵

>. The default password

for a new analyzer is 1 2 3 4.

Enter Password:

Press

to continue.

↵↵↵↵

3-2 EN October 2001

KC4 ∆∆∆∆™

General Operation

3.5 Program Modification

Selecting the tests to be available for each program

The programs ( Routine, Emergency, Individual) are modified by selecting tests from the keypad to form a desired group.

From the Main Menu screen, select 3 Selection screen, select:

Modify the Routine Program: This function allows the operator to select the tests

available to be run in the Routine Program. The tests are selected by pressing keys (INR, APTT, FIB, etc.) and confirming with < <ESC>. Upon termination, the previously set values will remain valid. In this program, the analyzer will allow a sequential operation of tests (Batch – mode).

Modify the Emergency Program: This function allows the operator to select the

tests available to be run in the Emergency Program. The tests are selected by pressing keys (INR, APTT, FIB, etc.) and confirming with < with <ESC>. Upon termination, the previously set values will remain valid. The analyzer will do a selected profile of tests on a single patient (Patient – Selective).

Modify the Individual program: This function allows the operator to individualize

the test menu by sample if desired. The tests in the Individual Program are chosen directly from the keyboard by pressing keys (INR, APTT, FIB, etc) and confirming with < values will remain valid.

↵↵↵↵

>. Terminating is possible with <ESC>. Upon termination, the previously set

To delete all programs.

Language Modify Parameter Check with Enter

Program Selection. From the Program

↵↵↵↵

>. Terminating is possible with

↵↵↵↵

>. Terminating is possible

WARNING: All tests one keystroke. A complete new installation of programs is necessary if all programs are deleted.

See Section 4 for a more detailed description of Program Modification.

in the programs and all test parameters

can be deleted with

October 2001 3-3 EN

3.6 Reagent Handling

KC4 ∆∆∆∆™

General Operation

Reagents for the appropriate test are prepared according to the manufacturer’s instructions. Refer to the manufacturer’s reagent application for specific instructions on preparation and handling of reagents. Any reagent requiring pre-heating should be placed into a 15-mm tube and inserted into the reagent incubation well. The fluid level in the tube should not be above the top edge of the incubation well. A minimum of 15 minutes will be required to warm reagent to 37°C±0.5°C. (Note: Reagents direct from the refrigerator may take slightly longer to warm up.) All reagents should be used before the expiration date listed by the manufacturer for each reagent. Do not place any opened reagent bottles on the instrument.

3.7 Cuvette Preparation

Tetravettes or micro cuvettes are placed in racks in the unheated preparation area. Up to twelve (12) cuvettes can be placed on the instrument. The exact size and surface quality of the cuvettes is critical to the proper performance of testing. Absolute cleanliness of cuvettes is mandatory to ensure correct performance. The cuvettes are intended as one-time use items. Rewashing cuvettes is not recommended. The performance of substitute cuvettes cannot be guaranteed; therefore, substitute cuvettes should not be used.

Tetravettes are cuvettes in pre-packaged groups of 4. They contain a stainless steel ball and can go directly into a loading rack and onto the instrument.

The stainless steel balls are manufactured from a special stainless steel. Purity, weight, size, surface quality and magnetic characteristics of the balls are all critical to the proper performance of testing. The balls, which are manufactured by Sigma/Amelung have been tested to ensure compatibility with the instrument measurement process and that they are inert when used with plasma and coagulation reagents. Rust, slight impurities or oil residue can have an adverse effect on coagulation testing results. The balls are intended as one-time use items. Recycling balls is not recommended. The performance of substitute balls cannot be guaranteed; therefore, substitute balls should not be used. The ball dispenser used in conjunction with the micro cuvettes, has been designed to facilitate transfer of balls into the cuvettes.

3-4 EN October 2001

KC4 ∆∆∆∆™

General Operation

3.8 Sample Preparation

Plasma samples and reagents are added with appropriate microliter pipettes. Refer to the manufacturer’s reagent application to determine the sample and reagent(s) volume required for each test. Pipetting technique is critical to the performance of testing. Refer to the Pipetting section for guidelines in proper pipetting technique. Although the use of a Multipette will facilitate initiation of measurement timing, special pipettes are not required. If a Multipette is not available, measurement timing can be started using the start button and channel buttons.

Sample is dispensed into the cuvette. Twelve o’clock is the recommended dispense position. After sample has been dispensed, close the Plexiglas flap, pick the cuvette rack up and swirl gently to evenly disperse the sample over the bottom of the cuvettes. Place the rack with cuvettes in the rotating test positions ensuring that the cuvettes are pressed firmly down to the bottom. Two additional racks of cuvettes (4 each) may also have samples pipetted and placed in the reaction incubation wells.

Care must be taken not to over incubate the samples. It is advisable to stagger the time interval between the cuvette racks in the heated incubation wells and rotating test positions to prevent over incubation. Allow the samples to pre-incubate for the recommended time. It will take slightly longer (a minimum of 120 seconds) for a sample that has been stored at refrigerator temperature (2–8°C) to reach 37°C than for samples stored at room temperature (18–26°C). Several of the coagulation factors, (Factors V, VIII, XIII, and fibrinogen) are labile at 37°C. To avoid loss of these factors, samples should not be pre-incubated longer than 5 minutes.

Timing is critical in coagulation testing and the reagent manufacturer’s guidelines for incubation times should be followed. Any particulate reagent must be well mixed prior to use. For those tests, having more than one reagent, all incubations prior to measurement start can be accomplished in the reaction incubation wells. Nine o’clock is the recommended first-reagent dispense position.

Care must be taken to avoid contact of the reagent pipette tip with previously dispensed sample. After addition of reagent, close the Plexiglas lid, pick up the cuvette rack, and swirl gently 5–6 times to mix the reagent and previously pipetted sample. The reaction mixture should be evenly dispersed around the channel at the bottom of the cuvette. No more cuvettes should be prepared for testing than can be completed within the specified guidelines.

In most instances, addition of a start reagent begins the coagulation process. It is important that the Measurement Timer or Multipette be started simultaneously to

the addition of the start reagent in order to ensure accuracy and precision of the assay. Test measurement timing can be started either manually using the Channel Key or

automatically by using the Multipette fitted with a starter cable. Use of a Multipette will ensure that the reagent addition starts measurement timing. Directions for both manual start and automatic start are described below.

The location of the start reagent dispense is important. To ensure that mixing of start reagent with the previously pipetted sample or sample/reagent mixture begins immediately, the start reagent should be dispensed just to the right side of the ball. This is best accomplished by holding the pipette angled obliquely from the right rear side of the cuvette towards the ball position and dispensing the reagent just to the right

October 2001 3-5 EN

KC4 ∆∆∆∆™

General Operation

of the ball. Care must be taken to avoid splashing the reagent out of the cuvette. The dispense rate should be of moderate speed and forcefulness.

3.9 Pipetting

The overall performance of the KC4∆™ Coagulation Analyzer is dependent on the accuracy and precision of pipetting both sample and reagent(s).

Testing can be performed with either standard microliter pipette(s) or with the Multipette fitted with a starting cable. When the Multipette is used to dispense the final start reagent, the timer is automatically started simultaneously with reagent dispense. When a standard microliter pipette is used for addition of the final start reagent, the timer is started manually using the Specific Channel Key.

Regardless of what kind of pipette is used, the care taken with pipetting is directly proportional to the overall accuracy and precision of testing.

To avoid contamination of reagents, if the same pipette is being used for both sample and reagent, a new tip must be used when transitioning between sample and reagent.

To avoid cross-contamination between samples, a new tip should be used for each sample, whether running plasma or whole blood samples.

Pipetting Technique for Non-Repeating Pipettes

To fill the pipette tip: Depress the button to the first stop. With the button depressed, insert the tip into the sample or reagent to a depth of approximately 2–3 mm. If pipetting plasma directly from a centrifuged tube of blood, the tip should be kept well away from the blood/plasma interface. This will assure that no red cells or platelets will be aspirated into the tip. If pipetting a particulate reagent, the reagent should be well mixed prior to aspiration.

Release the button slowly in such a manner that the sample or reagent flows smoothly into the pipette tip. Slow aspiration will assure that the volume aspirated into the tip is accurate. If the button is allowed to snap back, an incorrect volume may be aspirated. In addition, sample or reagent can be aspirated into the barrel of the pipette. This can result in contamination of subsequent samples or reagents. Unless the pipette is dismantled and cleaned, inadvertent aspiration into the pipette barrel will result in eventual obstruction and incorrect operation of the pipette.

Once the tip is filled, no dripping should be observed. If dripping is observed, either the tip is not seated correctly on the pipette or the pipette requires maintenance. In such a circumstance, replace the tip. If this does not correct the problem, the pipette should not be used until maintenance can be performed.

Pipetting Technique for Multipettes

Only pipette tips recommended for use with the pipette should be used. Any pipette tip whose insertion opening is out-of-round should be discarded. Any pipette tips that are bent or otherwise damaged should be discarded. The tip opening must not be occluded.

Slide the filling lever down until it stops, then raise the locking clamp upward.

Insert the combitip until it clicks into position. Be sure the combitip plunger is fully inserted into the barrel before attaching it to the Multipette. Be sure the filling lever is completely down and then lower the locking clamp to secure the combitip in place.

3-6 EN October 2001

KC4 ∆∆∆∆™

General Operation

Verify that the volume selection dial is set to dispense the correct volume. Immerse the combitip cone into the liquid. Fill by slowly sliding the filling lever upward. Wipe the combitip cone with a lint-free tissue. Follow the guidelines for correct dispense positions described in the following sections.

3.10 To Dispense Sample

Sample should be dispensed to the 12 o'clock position of the cuvette (see diagram). Aim the pipette to the 12 o'clock position. Position the tip approximately 3–4 mm above the bottom of the cuvette. Depress the pipette button to the first stop and hold for 1–2 seconds to allow the residual contents of the tip to collect at the bottom of the tip. Press the button to the second stop. This will deliver any residual sample into the cuvette. To avoid bubbling and splattering, the tip should not be placed so close to the bottom that at the completion of pipetting the tip is submersed in the dispensed sample. An alternative method is to touch the tip to the cuvette sidewall approximately 3–4 mm above the bottom of the cuvette and then depress the button slowly to the first stop. Wait 1–2 seconds and press the button to the second stop position. Sample should not be dispensed by touching the tip to the upper sidewalls of the cuvette. Any sample that is left on the upper walls will not participate in the coagulation reaction.

October 2001 3-7 EN

KC4 ∆∆∆∆™

General Operation

3.11 To Dispense First Reagent

For those tests utilizing more than one reagent, the first reagent should be dispensed to the 9 o'clock position of the cuvette (see diagram). Aim the pipette to the 9 o'clock position. Position the tip approximately 3–4 mm above the bottom of the cuvette. Depress the pipette button to the first stop and hold for 1–2 seconds to allow the residual contents of the tip to collect at the bottom of the tip. Press the button to the second stop. This will deliver any residual reagent into the cuvette. To avoid bubbling and splattering, the tip should not be placed so close to the bottom that at the completion of pipetting the tip is submersed in the dispensed reagent. An alternative method is to touch the tip to the cuvette sidewall approximately 3–4 mm above the bottom of the cuvette and then depress the button slowly to the first stop. Wait 1–2 seconds and press the button to the second stop position. To avoid contamination of reagent during subsequent reagent pipetting, care must be taken to avoid contact of the tip with the previously dispensed sample.

3-8 EN October 2001

KC4 ∆∆∆∆™

General Operation

3.12 To Dispense Start Reagent

The Start Reagent is the reagent that, when added, begins the coagulation reaction. Start Reagent should be dispensed just to the right side of the ball. This positioning assures that mixing of reagent with the other reaction constituents begins immediately. Holding the pipette obliquely from the right side, aim the pipette tip to the right side of the ball. Position the tip approximately 5–6 mm above the ball. Depress the pipette button to the last stop position. The dispense rate should not be so rapid or forceful that reagent is splashed out of the cuvette. To avoid contamination of reagent during subsequent reagent pipetting, care must be taken to avoid contact of the tip with the previously dispensed sample and/or reagent (see diagram).

October 2001 3-9 EN

3.13 Selecting a Test to Begin a Run

KC4 ∆∆∆∆™

General Operation

From the Main Menu, Press <

Pat. ID: 333

Position 1234

Inc. Time 0000

Meas. Time 0000

Start Inc.

Ready

The upper left shows the current patient ID and the upper right shows the temperature of the measuring block in °C.

<MENU> Accesses up Main Menu functions.

<RUN> accesses the Program Menu.

↵↵↵↵

>. The Operating Screen will be displayed.

Operating Screen

37°C

1234

Select 1 Enter the Patient ID, press < into the Routine Program (see Section 4). For example, if INR, APTT and FIB are in the Routine Program, then the first test to be performed will be INR. INR will appear in the upper right corner of the Operating Screen (replacing the temperature). To scroll to the next test in the program (ie. APTT), press < the number of samples per rack, press < will appear in the upper right corner of the Operating Screen. To end the program, press <RUN>.

Select 2 programmed in the Emergency Program will appear in the upper right corner of the

Operating Screen. Only one sample at a time can be run in the Emergency Program. At the end of the first test, the result will be displayed. Record the result, Press < <RUN>.

Select 3 Individual Program will be displayed (see section 4). Select a test by pressing the

test Function Key. For example, INR, APTT and FIB are displayed on the grid. To begin INR testing, press the INR key. Press < press < corner, and the Patient ID will be displayed in the upper left corner of the Operating Screen.

Routine Program. Select number of samples per rack, press <

↵

>. The analyzer will display the first test programmed

↵ ↵

↵

>. The next test in the program (APTT),

↵ ↵

↵

Emergency Program. Enter Patient ID, press <

↵

> to scroll to the next test in the program. To end the program, press

↵ ↵

Individual Program. A grid of available tests programmed into the

↵

>. Enter number of samples per rack,

↵ ↵

↵

>; enter Patient ID, press <

↵ ↵

↵

>. INR will be displayed in the upper right

↵ ↵

↵

>. The first test

↵ ↵

↵↵↵↵

↵

>. Enter

↵ ↵

3-10 EN October 2001

KC4 ∆∆∆∆™

General Operation

Note: When entering the number of samples per rack: if testing in duplicate, Max

would be 2 and the choice of 1 pair or 2 pair per rack would be made. It is recommended that samples be analyzed in duplicate.

Samples per rack Count: 2

Max = 2

3.14 Patient Identification

After the number of samples per rack has been entered, the analyzer will ask for a Patient ID number. Press 1 increment up from this number. Press 2 be analyzed.

Note: This screen must be re-accessed to enter subsequent Patient ID

numbers. To do this, press the RUN key, select 3 Press the appropriate test key. Theer the number of samples per rack (2 when analyzing in duplicate); select 2

to enter a Patient ID. The instrument will automatically

to enter a specific Patient ID for the samples to

Individual Program.

for manual Patient ID entry.

ROUTINE PROGRAM Patient ID: Start Patient ID Modify 1 Manual Patient ID 2

↵↵↵↵

Press

to Continue

3.15 Testing

1. With the transfer of the first rack to the rotating wells, Press Incubation timer:

Operating Screen

Patient ID: 333 INR

Position 1234

Inc. Time 0000

Meas. Time 0.0 0.0 0.0 0.0

Start Inc. *** ***

READY

2. Press Channel timer for each sample to be tested.

October 2001 3-11 EN

KC4 ∆∆∆∆™

General Operation

3. Each channel will begin the incubation countdown. An audible beep will occur when 5 seconds remain.

4. Press and hold down the <START> key and begin dispensing the start reagent.

3.16 Manual Start Procedure

Install a pipette tip onto an appropriately sized pipette.

Mix particulate reagent by covering the tube with Parafilm® and inverting gently. Do not shake. Many coagulation reagents are mixtures of lipids, which will undergo spatial rearrangement when shaken.

Aspirate reagent into the pipette tip. Dispense one aliquot of reagent into reagent container to prime the pipette tip.

Press the <START> key.

Dispense reagent just to the right side of the ball and simultaneously press the Specific

Channel Key .

Note: Measurement can be started automatically if the reagent is dispensed with

enough force to move the ball from its steady position. This is best accomplished by dispensing the reagent directly onto the right side of the ball. This dispense should not be so forceful that any of the reaction mixture is splashed out of the cuvette. This is not as reliable a way to start timing. It is particularly unreliable when dispensing a volume less than 100 µl.

3.17 Automatic Start Procedure

The KC4∆ Multipette is recommended for use in the Automatic Start Procedure.

Assure that the Multipette cable is plugged into the Automatic Pipette socket located on the rear of the KC4

Install appropriately sized pipette tip.

Mix particulate reagent by covering the tube with Parafilm® and inverting it gently. Do not shake. Many coagulation reagents are mixtures of lipids, which will undergo spatial rearrangement when shaken. The reactivity of such reagents is dependent on the specific lipid arrangement.

Aspirate start reagent into the pipette tip. Dispense one aliquot of reagent into reagent container to prime the pipette tip.

∆

Coagulation Analyzer.

Press the <START> key.

Fully depress the pipetting lever to dispense reagent. This is best accomplished by holding the pipette angled obliquely from the right rear side and dispensing the reagent just to the right side of the ball. Measurement timing is started automatically.

Return the pipette to the heated pipette tube holder. Note: Replace the pipette tube holder sleeves daily and for each new reagent. Pipette tube holder sleeves should be treated as biohazardous waste.

3-12 EN October 2001

KC4 ∆∆∆∆™

General Operation

Note: To increase speed when using an automatic multipette with starting cable,

simple keep the Start Key of the first channel depressed while pipetting. Thus, when channel 1 is pipetted and the timer for channel 1 is started, the timer for channel 2 is activated. When channel 2 is pipetted, its timer begins and channel 3’s timer is activated, etc.

With the addition of start-reagent, initiation of the coagulation process begins. As coagulation takes place, fibrinogen polymerizes to form strands of fibrin. The formed fibrin sweeps the ball out of its steady position, which triggers an impulse in the magnetic sensor. This impulse electronically stops the timer signifying the end of measurement time. The elapsed time will be displayed in seconds and tenths of seconds.

3.18 Printing Results

1. The printer will immediately print out the results of the first test. The second test

results will be printed after <

Individual Program: INR Date : 25 Nov 2001 Time : 01:11 Patient ID : 25 Measured Values: Value 1 : 12,4 sec Value 2 : 12,1 sec Average Value : 12,25 sec Difference : 2,4 %

↵↵↵↵

> is pressed.

Result : 1,02

Individual Program: INR Date: 25 Nov 2001 Time: 01:12 Patient ID: 26 Measured Values: Value 1 : 12,0 sec Value 2 : 12,3 sec Average Value : 12,15 sec Difference : 2,4 %

Result : 1,01

Individual Program: INR Date: 25 Nov 2001 Time: 01:14 Patient ID: 27 Measured Values: Val ue 1 : 11 , 5 s ec Val ue 2 : 11 , 2 s ec Average Value : 11,35 sec Difference : 2,6 %

Result : 0,93

October 2001 3-13 EN

KC4 ∆∆∆∆™

Mode Programming

4Mode Programming

Contents

4.1 ROUTINE PROGRAMMING...................................................................... 4-1

4.2 EMERGENCY PROGRAMMING................................................................ 4-2

4.3 INDIVIDUAL PROGRAMMING ................................................................. 4-3

October 2001 4-0 EN

KC4 ∆∆∆∆™

Mode Programming

4.1 Routine Programming

From the MAIN MENU: Select 3

Enter Password, press

ENTER <

, Program Selection.

↵↵↵↵

Main Menu

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Password Screen

Enter Password:

Press

to continue.

↵↵↵↵

Press 2

, Routine Program Modify.

Select from the keypad all tests desired for this group. When complete, press ENTER <

↵↵↵↵

Tests programmed will cycle, allowing parameter changes to be made.

See Section 5 regarding programming tests.

Modify Screen

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Language Modify 6

Parameter Check to Enter

Routine Program

Tests

In Routine Program

INR APTT FIB

New entry press ENTER to store

Press ESC to cancel

Programming Screen

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Press ENTER to continue

October 2001 4-1 EN

4.2 Emergency Programming

S I G M A - A M E L U N G

From the MAIN MENU: Press 3

Enter Password, press ENTER < to continue.

, Program Selection.

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

↵↵↵↵

Enter Password:

KC4 ∆∆∆∆™

Mode Programming

Main menu

KC 4 DELTA

Password Screen

Press 3

, Emergency Program

Modify.

Choose tests from the keypad for this group. When complete, press

ENTER <

↵↵↵↵

Tests will cycle allowing for Parameter changes to be made.

See Section 5 for programming changes.

Press

to continue.

↵↵↵↵

Modify Screen

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Press ENTER to continue

Emergency Screen

Tests

In Emergency program

INR APTT FIB

New entry press ENTER to store

Press ESC to cancel

Programming Screen

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

4-2 EN October 2001

KC4 ∆∆∆∆™

Mode Programming

4.3 Individual Programming

S I G M A - A M E L U N G

From the MAIN MENU: Press 3

Enter Password, press ENTER<

, Program Selection.

↵↵↵↵

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Enter Password:

Press

Main Menu

KC 4 DELTA

Password Screen

to continue.

↵↵↵↵

Press 4

, Individual Program Modify

Choose tests from the keypad for this group. When complete, press

ENTER <

When complete, press ENTER <

↵↵↵↵

Tests will cycle for parameter changes.

See Section 5 for programming information.

Modify Screen

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Press ENTER to continue

Individual Screen

Tests

In Individual Programming

INR APTT FIB

New entry press ENTER to store

Press ESC to cancel

Programming Screen

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Press ENTER to continue

October 2001 4-3 EN

KC4 ∆∆∆∆™

Test Programming

5Test Programming

Contents

5.1 INR........................................................................................................ 5-1

5.2 INR FLOW CHART.................................................................................. 5-3

5.3 PROTHROMBIN TIME (PERCENT ACTIVITY CURVE)............................... 5-4

5.4 PT (PERCENT ACTIVITY) FLOW CHART.................................................. 5-7

5.5 RATIO FLOW CHART ............................................................................. 5-8

5.6 ACTIVATED PARTIAL THROMBOPLASTIN TIME..................................... 5-9

5.7 APTT FLOW CHART ..............................................................................5-11

5.8 FIBRINOGEN ........................................................................................5-12

5.9 FIBRINOGEN FLOW CHART ..................................................................5-15

5.10 FACTORS..............................................................................................5-16

5.11 FACTORS FLOW CHART .......................................................................5-19

5.12 STATS ..................................................................................................5-20

October 2001 5-0 EN

KC4 ∆∆∆∆™

Test Programming

5.1 INR

The INR (International Normalized Ratio) is the preferred method for reporting Prothrombin Times in the United States. The P T percent activity curve and ratio are preferred in Europe.

Allow the instrument to reach 37°C prior to testing.

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Prior to testing, a Test Program or profile needs to be established. The three programs available are discussed in Section 4. The Individual Program will be used here.

At the MAIN MENU,

1. Press 3

2. Enter 4

3. Press <

, Program Selection.

digit Password:_ _ _ _;

↵↵↵↵

4. Select Individual Program Modify 4

5. Choose tests from the keypad.

6. Press <

↵↵↵↵

> to store.

Enter Password:

Press

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Tests

In individual program

New entry press ENTER

Press ESC to cancel

to continue.

↵↵↵↵

Press ENTER to continue

INR

to store

↵↵↵↵

October 2001 5-1 EN

KC4 ∆∆∆∆™

Test Programming

7. Select Yes (1) to change settings or select No (2) to leave as programmed.

8. To test in duplicate, select Yes (1) or No (2) for single testing, press <

↵↵↵↵

9. Enter the maximum difference allowed, where: Max difference (%) = (difference between values divided by the mean value) x 100

Program INR:

Incubation Time (sec) :

Default Value :

ISI-Value :

Max. Difference (%) :

Modify? Yes 1 No 2

INR – Program

Double Test?

Yes 1 N o 2

Max. Difference (%) :

to continue

↵↵↵↵

Press

Max. Difference (%): 10

New entry press

Press ESC to continue

to store

↵↵↵↵

10. Program the incubation time referenced in the test application.

11. Default Value is the PT Mean Normal*

12. ISI Value for the thromboplastin in use.

13. Max. Difference as determined above.

14. Select No (2) when modification is complete. The cycle will return to the

Incubation Time (sec) : 60

Default Value : 12,2

ISI-Value : 1.78

Max. Difference (%) : 10

Modify? Yes 1 No 2

Program INR:

MAIN MENU when all modifications are complete.

The KC4

∆

™ will automatically calculate the INR using the programmed values entered

for the mean of the Reference Range and the ISI value for the thromboplastin in use.

* Prior to entering values, a reference range should be determined for the lot number of thromboplastin that will be used. Because PT reference ranges can vary between laboratories and between different reagent formulations, determination of the reference range on the population being served is recommended. For accurate INR reporting, the determination of the geometric mean is recommended. When the geometric mean has been determined, values may be programmed into the KC4

∆

™.

5-2 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.2 INR Flow Chart

Program INR:

Incubation Time (sec) :

Default Value :

ISI-Value :

Max. Difference (%) :

Modify? No 2

Yes 1

INR – Program

Double Test?

Yes 1 No 2

Max. Difference (%) :

to continue

↵

Press ↵

↵↵

Program INR

Incubation time (sec): ?

New entry press

Press ESC to continue

Program INR

Default value:

New entry press

Press ESC to continue

Program INR

ISI-Value:

to store

↵↵↵↵

to store

↵↵↵↵

Max. Difference (%): 10

New entry press

Press ESC to continue

INR – Program

Double Test?

Yes 1 No 2

Max. Difference (%) :

to continue

↵↵↵↵

Press

to store

↵↵↵↵

New entry press

Press ESC to continue

Program INR:

Incubation Time (sec) : 60

Default Value : 12,2

ISI-Value : 1.78

Max. Difference (%) : 10

Modify? Yes 1 No 2

to store

↵↵↵↵

NEXT TEST

October 2001 5-3 EN

KC4 ∆∆∆∆™

Test Programming

5.3 Prothrombin Time (Percent Activity Curve)

Allow the instrument to reach 37°C prior to testing.

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Prior to testing, a Test Program or profile needs to be established. The three programs available are discussed in Section 4. The Individual Program will be used here.

At the MAIN MENU:

1. Press 3

2. Enter 4

3. Press <

, Program Selection.

digit Password:_ _ _ _;

↵↵↵↵

4. Select Individual Program Modify 4

5. Choose tests from the keypad.

6. Press <

↵↵↵↵

> to store.

Enter Password:

Press

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Tests

In individual program

New entry press ENTER

Press ESC to cancel

to continue.

↵↵↵↵

Press ENTER to continue

to store

↵↵↵↵

5-4 EN October 2001

KC4 ∆∆∆∆™

Test Programming

7. Select Yes (1 ) to change settings or select No (2)

to leave as programmed.

8. Press Yes ( 1) if testing is to be done in duplicate, or No (2) if in single.

Program PT:

Incubation Time (sec) : ?

Calibration Curve PT : ?

Point 1 (%) : ?

(sec) : ?

Point 2 (%) : ?

(sec) : ?

Point 3 (%) : ?

(sec) : ?

PT MAX % : ?

Difference Check PT : No

Modify? Yes 1 No 2

PT – Program

Double Test?

Yes 1 No 2

Max. Difference (%) :

to continue (more

↵↵↵↵

Press parameters)

9. Enter the maximum difference allowed, where: Max difference (%) = (difference between values divided by the mean value) x 100

10. Program the incubation time referenced in the test application.

11. Enter the reference value of the PT calibration curve. This is the first point, the highest point of the curve. This does not have to be 100%, it may vary depending on the source of the reference plasma.

12. Enter the clotting time in seconds of the first point of the PT calibration curve.

Max. Difference (%): ?

New entry press

Press ESC to continue

Program PT:

Incubation Time (sec) : 60

Calibration Curve PT : ?

Point 1 (%) : 100

Point 2 (%) :

Point 3 (%) :

PT MAX % :

Max. Difference (%) : 10

Modify? Yes 1 No 2

to store

↵↵↵↵

(sec) : 12

(sec) :

October 2001 5-5 EN

KC4 ∆∆∆∆™

Test Programming

13. Enter the second value of the P T calibration curve. The second point, the middle point of the curve is a dilution of the reference plasma. Example: 30% is used.

14. Enter the clotting time in seconds for the middle point of the PT calibration curve.

15. Enter the third value of the PT calibration curve. The third point, the lowest point of the curve is a dilution of the reference plasma. Example: 12.5% is used:

16. Enter the clotting time in seconds of the third point of the PT calibration curve.

17. Enter the Maximum % P T value. Values exceeding maximum value entered are not printed out. Example: 130% is used.

Program PT:

Incubation Time (sec) : 60

Calibration Curve PT : ?

Point 1 (%) : 100

(sec) : 12

Point 2 (%) : 30

(sec) : 27

Point 3 (%) :

(sec) :

PT MAX % :

Max. Difference (%) : 10

Modify? Yes 1 No 2

Program PT:

Incubation Time (sec) : 60

Calibration Curve PT : ?

Point 1 (%) : 100

(sec) : 12

Point 2 (%) : 30

(sec) : 27

Point 3 (%) : 12.5

(sec) : 62

PT MAX % : 130

Max. Difference (%) : 10

Modify? Yes 1 No 2

18. Select No (2), when modification is complete. The cycle will return to the MAIN MENU when all modifications are complete.

5-6 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.4 PT (Percent Activity) Flow Chart

Program PT:

Incubation Time (sec) : ?

Calibration Curve PT : ?

Point 1 (%) : ?

(sec) : ?

Point 2 (%) : ?

(sec) : ?

Point 3 (%) : ?

(sec) : ?

PT MAX % : ?

Difference Check PT : No

Modify? Yes 1

PT – Program

Double Test?

Yes 1 No 2

Max. Difference (%)

to continue

Press

↵↵↵↵

No 2

NEXT TEST

Program PT:

Incubation Time (sec) : 60

Calibration Curve PT : ?

Point 1 (%) : 100

(sec) : 12

Point 2 (%) : 30

(sec) : 27

Point 3 (%) : 12.5

(sec) : 62

PT MAX % : 130

Max. Difference (%) : 10

Modify? Yes 1

No 2

NEXT TEST

Max. Difference (%) ?

New entry press

Press ESC to continue

PT – Program

Double Test?

Yes 1 No 2

Difference Check: No

to continue

Press

↵↵↵↵

to store

↵↵↵↵

October 2001 5-7 EN

5.5 Ratio Flow Chart

KC4 ∆∆∆∆™

Test Programming

PROGRAM RATIO:

Incubation time (sec): 0

Default Value: 0,0

Max. Difference (%): ?

RATIO: No

Modify? Yes 1 No 2

RATIO – Program

Double Test?

Yes 1 No 2

Max. Difference (%): ?

to continue

↵↵↵↵

Press

Press ESC to continue

PROGRAM RATIO:

Incubation time (sec): 0

Default Value: 0,0

Difference Check RATIO: No

Modify? Yes 1 No 2

Program RATIO

Incubation time (sec): 0

New entry press

Press ESC to continue

Program RATIO

Default Value:

to store

↵↵↵↵

Max. Difference (%):

New entry press

Press ESC to continue

RATIO – Program

Double Test?

Yes 1 No 2

Max. Difference (%):

to continue

Press

↵↵↵↵

to store

↵↵↵↵

New entry press

Press ESC to continue

PROGRAM RATIO:

Incubation time (sec): 0

Default Value: 0,0

Max. Difference (%): 5%

RATIO: No

Modify? Yes 1 No 2

to store

↵↵↵↵

NEXT TEST

5-8 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.6 Activated Partial Thromboplastin Time

Allow the instrument to reach 37°C prior to testing.

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Prior to testing, a Test Program or profile needs to be established. The three programs available are discussed in Section 4. The Individual Program will be used here.

At the MAIN MENU:

1. Press 3

, Program Selection.

2. Enter 4 digit Password:_ _ _ _;

3. Press <

↵↵↵↵

4. Press Individual Program Modify 4

5. Choose tests from the keypad.

6. Press <

↵↵↵↵

Enter Password:

Press

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Tests

In individual program

New entry press ENTER

Press ESC to cancel

to continue.

↵↵↵↵

Press ENTER to continue

APTT

to store

↵↵↵↵

7. Select Yes (1) to change settings or select No (2) to leave as programmed.

Program – PTT

Incubation time (sec): 240

Max. Difference (%): ?

Modify? Yes 1 No 2

October 2001 5-9 EN

KC4 ∆∆∆∆™

Test Programming

8. To test in duplicate, select Yes (1) or Select No (2) to test in single.

9. Enter the maximum value allowed,

PTT – program

Double Test?

No 2

Yes 1

Max. Difference (%): ?

to continue

Press

↵↵↵↵

Max. Difference (%): 10

where: Max difference (%) = (difference between values divided by the Mean value) x 100.

New entry press

Press ESC to continue

to store

↵↵↵↵

10. Program the incubation time referenced in the test application.

11. Select No (2) when modifications are complete. The cycle will return to the Main Menu when all modifications are complete.

5-10 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.7 APTT Flow Chart

Program – PTT

Incubation time(sec): ?

Max. Difference(%): ?

Modify? Yes

PTT – program

Double Test?

Yes 1 No 2

Max. Difference(%): ?

Press

1No 2

to continue

↵↵↵↵

Program – PTT

Incubation time (sec): 240

Max. Difference (%): 10

Modify? Yes 1 No 2

Program – PTT

Incubation time (sec): 240

Max. Difference (sec): 10

Modify? Yes 1 No 2

Max. Difference(%): ?

New entry press

Press ESC to continue

PTT – program

Double Test?

Yes 1 No 2

Difference Check: No

to continue

↵↵↵↵

Press

to store

↵↵↵↵

Next Test

October 2001 5-11 EN

KC4 ∆∆∆∆™

Test Programming

5.8 FIBRINOGEN

Prior to programming Fibrinogen, the concentration of the calibration curve points and the clotting time for each point must be known.

Allow the instrument to reach 37°C prior to testing.

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Prior to testing, the test must be programmed into a testing format as discussed in Section 4. The Individual Program will be used here.

At the MAIN MENU:

1. Press 3

, for Program Selection.

2. Enter 4 digit Password:_ _ _ _.

3. Press <

↵↵↵↵

4. Press Individual Program Modify 4

5. Choose tests from the keypad.

6. Press <

↵↵↵↵

Enter Password:

Press

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Tests

In individual program

New entry press ENTER

Press ESC to cancel

to continue.

↵↵↵↵

Press ENTER to continue

FIB

to store

↵↵↵↵

5-12 EN October 2001

KC4 ∆∆∆∆™

Test Programming

7. To modify, select Yes (1) to change or, No (2) to

test in leave as programmed.

8. Press Yes ( 1) if testing is to be done in duplicate or Press No (2) if in single.

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 1 (G/L) :

(sec) :

Point 2 (G/L) :

(sec) :

Point 3 (G/L) :

(sec) :

Dilution 1:5

Max. Difference (%) :

Modify? Yes 1 No 2

FIB – Program

Double Test?

Yes 1 No 2

Max. Difference (%) :

to continue

Press

↵↵↵↵

9. Enter the maximum difference allowed, where: Max difference (%) = (difference between values divided by the Mean value) x 100

10. Press <

↵↵↵↵

> to continue changing parameters.

Max. Difference (%):

New entry press

Press ESC to continue

FIB – Program

Double Test?

Yes 1 No 2

Max. Difference (%) :

to continue

↵↵↵↵

Press

to store

↵↵↵↵

October 2001 5-13 EN

Test Programming

11. Choose the incubation time referenced in the test application.

KC4 ∆∆∆∆™

12. Enter the reference value of the Fibrinogen reference plasma in G/L for the first point of the curve. This can vary depending on the source of the reference plasma. When using the KC4

∆

™ Coagulation Analyzer, care should be taken that the clot time of the highest point is more than the minimum read time (4.5 sec.) of the instrument. This can be achieved by utilizing the optimal dilutions for the reference plasma referred to in the reagent applications.

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 1 (G/L) :

(sec) :

Point 2 (G/L) :

(sec) :

Point 3 (G/L) :

(sec) :

Dilution 1:5

Max. Difference (%) :

Modify? Yes 1 No 2

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 4 (G/L) :

(sec) :

Point 5 (G/L) :

(sec) :

Dilution 1:5

Difference Check FIB : No

Modify? Yes 1 No 2

13. Enter the clotting time in seconds for the first point of the Fibrinogen reference curve.

14. Enter the second value for the Fibrinogen reference curve. The second point is a dilution of the reference plasma.

15. Enter the clotting time in seconds for the second point of the Fibrinogen reference curve.

16. Enter the third value for the Fibrinogen reference curve. The third point is a dilution of the reference plasma.

17. Enter the clotting time in seconds for the third point of the Fibrinogen reference curve.

18. Enter the fourth value of the Fibrinogen reference curve. The fourth point is a dilution of the reference plasma.

19. Enter the clotting time in seconds for the fourth point of the Fibrinogen reference curve.

20. Enter the fifth value of the Fibrinogen reference curve. The fifth point is a dilution of the reference plasma.

21. Enter the clotting time in seconds for the fifth point of the Fibrinogen reference curve.

22. Enter the dilution for the patient or control samples to be analyzed. Fibrinogens use a 5 point reference curve.

23. Select No (2) when modifications are complete. The cycle will return to the Main

Menu when all modifications are complete.

Note: Suggested dilutions and volumes used are found in the KC4

∆

™ Fibrinogen

Application.

5-14 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.9 Fibrinogen Flow Chart

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 1 (G/L) :

(sec) :

Point 2 (G/L) :

(sec) :

Point 3 (G/L) :

(sec) :

Dilution 1:5

Program FIB

Incubation time (sec):

New entry press

Press ESC to cancel

Program FIB

Calibration curve FIB :

New entry press

Press ESC to cancel

to store

↵↵↵↵

to store

↵↵↵↵

Max. Difference (%) :

Modify? Yes 1

FIB – program

Double Test?

Yes 1 No 2

Max. Difference(%):

to continue

Press

↵↵↵↵

Max. Difference (%):

New entry press

Press ESC to continue

FIB – program

Double Test?

Yes 1 No 2

to store

↵↵↵↵

No 2

Program FIB

Point 1 (G/L) :

New entry press

Press ESC to cancel

Continue through all parameters

of the program.

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 1 (G/L) :

(sec) :

Point 2 (G/L) :

(sec) :

Point 3 (G/L) :

(sec) :

Dilution 1:5

to store

↵↵↵↵

Program – FIB:

Incubation Time (sec) :

Calibration Curve FIB:

Point 4 (G/L) :

(sec) :

Point 5 (G/L) :

(sec) :

Dilution 1:5

Difference Check FIB : No

Modify? Yes 1 No 2

Max. Difference(%):

to continue

↵↵↵↵

Press

Difference Check FIB : No

Modify? Yes 1 No 2

NEXT TEST

October 2001 5-15 EN

KC4 ∆∆∆∆™

Test Programming

5.10 FACTORS

Prior to programming Factors, the concentration of the calibration curve points must be known and the clotting time for each point must be established.

Allow the instrument to reach 37°C prior to testing.

S I G M A - A M E L U N G

KC 4 DELTA

DATE: 12 Sep 2001 1

TIME: 10 : 08 2

PROGRAM SELECTION 3

PRINT PARAMETERS 4

Prior to testing, a Test Program or profile needs to be established. The three programs available are discussed in Section 4. The Individual Program will be used here.

At the MAIN MENU:

1. Press 3

, Program Selection.

2. Enter 4 digit Password:_ _ _ _.

3. Press <

↵↵↵↵

4. Select Individual Program Modify 4

5. Choose desired tests from the keypad.

6. Press <

↵↵↵↵

Enter Password:

Press

Password Modify 1

Routine Program Modify 2

Emergency Program Modify 3

Individual Program Modify 4

Delete all programs 5

Tests

In individual program

New entry press ENTER

Press ESC to cancel

to continue.

↵↵↵↵

Press ENTER to continue

FAC

to store

↵↵↵↵

5-16 EN October 2001

KC4 ∆∆∆∆™

Test Programming

7. Select Yes (1) to change settings or select No (2)

to go to the next test.

8. To test in duplicate, select Yes (1) or No (2) for

single.

PROGRAM FAC Factor = 0

Incubation Time (sec) :

Count Points :

Calibration Curve F ?

Point 1 (%) : 0,0

(sec) : 0,0

Point 2 (%) : 0,0

(sec) : 0,0

Point 3 (%) : 0,0

(sec) : 0,0

Modify? Yes 1 No 2 (next test)

FAC – Program

Double Test?

Yes 1 No 2

Max. Difference: ?

to continue

↵↵↵↵

Press

9. Enter the maximum difference allowed, where: Maximum value (%) = (difference between values)/mean value x 100.

10. Press <

↵↵↵↵

> to continue.

Max. Difference(%): 0

New entry press

Press ESC to continue

FAC - Program

Double Test?

Yes 1 No 2

Max. Difference: ?

Press

Note: Only one factor curve may be entered at a time.

to continue

↵↵↵↵

to store

↵↵↵↵

October 2001 5-17 EN

KC4 ∆∆∆∆™

Test Programming

11. Enter the Factor that will be used.

12. Enter an incubation time referenced in the test application.

13. Choose as many Curve Points (Count Points) as appropriate for testing requirements (9 points max).

14. Enter the reference value of the Factor calibration curve. This is the first point, the highest point of the curve. This does not always have to be 100%, it can vary depending on the source of the reference plasma.

15. Enter the clotting time in seconds of the first point of the Factor calibration curve.

16. Continue entering percentage points and seconds to complete the calibration curve.

17. Select No (2) when modifications are complete. The cycle will return to the Main Menu when all modifications are complete.

PROGRAM FAC Factor = 0

Incubation Time (sec) :

Count Points :

Calibration Curve F ?

Point 1 (%) : 0,0

(sec) : 0,0

Point 2 (%) : 0,0

(sec) : 0,0

Point 3 (%) : 0,0

(sec) : 0,0

Modify? Yes 1 No 2 (next test)

5-18 EN October 2001

KC4 ∆∆∆∆™

Test Programming

5.11 Factors Flow Chart

PROGRAM FAC Factor = 0

Incubation Time (sec) :

Count Points :

Calibration Curve F ?

Point 1 (%) : 0,0

(sec) : 0,0

Point 2 (%) : 0,0

(sec) : 0,0

Point 3 (%) : 0,0

(sec) : 0,0

Modify? Yes 1

FAC – Program

Double Test?

Yes 1 No 2

Max. Difference: ?

Press ENTER

Max. Difference (%):

New entry press

Press ESC to continue

No 2 (next test)

to continue

↵↵↵↵

to store

↵↵↵↵

Program FAC

Incubation time (sec):

New entry press

Press ESC to cancel (through remaining parameters)

After final parameter has been entered.

PROGRAM FAC Factor = 0

Incubation Time (sec) :

Count Points :

Calibration Curve F ?

Point 1 (%) : 0,0

Point 2 (%) : 0,0

Point 3 (%) : 0,0

Modify? Yes 1 No 2

to store

↵↵↵↵

(sec) : 0,0

(next test)

FAC – Program

Double Test?

Yes 1 No 2

Difference Check: No

Press ENTER

to continue

↵↵↵↵

NEXT TEST

October 2001 5-19 EN

Test Programming

5.12 STATS

STATS are programmed in Section 4.2 Emergency Program.

KC4 ∆∆∆∆™

1. From the MAIN MENU or if ROUTINE testing is in progress, press < the Operating screen:

2. From the keypad press <RUN>.

3. At the Test Selection Screen, choose Emergency Program (2

Operating Screen. If 2 beeps sound, nothing has been programmed; see Section 4.

↵↵↵↵

4. If multiple tests are grouped in the STAT Mode; press < in the group.

> to change to other tests

) to bring up the

↵↵↵↵

> to bring up

5-20 EN October 2001

KC4 ∆∆∆∆™

Quality Control

6Quality Control

Regularly performed quality control is the best monitor of test performance. To assure that control and unknown sample results are evaluated under the same test conditions, control material should be included with each run.

The reagent manufacturer's QC recommendations should be used as a guide for establishing a QC protocol. Control results deviating from established ranges are indicative of a system failure and should be investigated immediately. The more common sources of error and the corrective action to take are presented in the Troubleshooting section, Section 8.

October 2001 6--1 EN

KC4 ∆∆∆∆™

Maintenance

7Maintenance

Introduction

There is no routine mechanical maintenance associated with the KC4∆™. The KC4∆™ was factory calibrated for rotational speed, magnetic sensor strength and temperature.

General housekeeping is the only maintenance that need be performed with any regularity. Occasional cleaning with a damp paper towel is recommended to remove accumulated dust or other material. Spills should be cleaned up as they occur.

Reagents can be corrosive and any spillage into the reagent incubation well should be cleaned up immediately. All sample spills should be considered to have created a potentially biohazardous environment and should be cleaned up immediately using appropriate safeguards to avoid personal contamination. If decontamination is required, wipe area with a paper towel moistened with a mild disinfectant.

Any balls that inadvertently find their way into the bottom of any of the wells can be removed using a magnet.

October 2001 7-0 EN

KC4 ∆∆∆∆™

Troubleshooting

8Troubleshooting

Contents

8.1 TROUBLESHOOTING FLOW DIAGRAM ................................................... 8-1

8.2 TROUBLESHOOTING PROCEDURES TABLE............................................ 8-1

October 2001 8-0 EN

KC4 ∆∆∆∆™

Troubleshooting

8.1 Troubleshooting Flow Diagram

8.2 Troubleshooting Procedures Table

Symptoms Possible Causes Corrective Action

After pressing On/ Off, the display is

empty; measurement well is not rotating.

After pressing On/ Off, temperature fails to stabilize at 37 measurement well is rotating.

Controls are in range

Unexpected results on patient samples.

Instrument Error

∆

KC4 power supply or power supply not connected to outlet.

Instrument Error

Nonfunctional sensor or thermostat overheating.

Pre-Analytical error

Overfill or underfill of collection tube.

Pre-Analytical error

Incorrect volume, type (e.g., EDTA, heparin), concentration or lack of anticoagulant.

™ not connected to

Assure that the connecting cable is seated firmly in the power supply socket. Assure that the power supply cord is connected to the appropriate outlet.

Place approximately 3 ml water into a 15 mm test tube. Insert a thermometer. Observe temperature after a 10–15 minute equilibration period.

Call Sigma Diagnostics Technical Service 1-800-325-0250.

Full draw in commercial vacuum tubes assures correct blood/anticoagulant ratio.

Use anticoagulant as recommended by the reagent manufacturer.

October 2001 8-1 EN

KC4 ∆∆∆∆™

Troubleshooting

Symptoms Possible Causes Corrective Action

(continued)

Controls are in range

Unexpected results on patient samples.

Pre-Analytical error

Ratio of anticoagulant to blood is inappropriate.

Pre-Analytical error

Clotted specimen.

Failure to correct citrate volume for patients with high (>55%) or low (<21%) hematocrit.

Testing should never be performed on specimens containing micro or macro clots.

Controls out of range

Unexpected results.

Pre-Analytical error

Inadequate or too vigorous mixing of specimen.

Pre-Analytical error

Contamination with heparin.

Pre-Analytical error

Delay in transporting or processing or the use of nonstandardized procedures for transporting, processing, storing or testing the specimen.

Pre-Analytical error

Contact with glass.

Sample related

Loss of Factors V and VIII

Sample related

Incorrect volume being used.

Reagent related

Contaminated reagents.

Invert gently to mix well without mechanical trauma.

Do not draw blood from a heparin lock or any other heparinized line.

Follow manufacturer’s instructions.

Centrifuge immediately. Centrifuge at correct rcf for correct time interval.

Store no longer than 4 hours at room temperature or refrigerated temperatures.

Transfer plasma to plastic storage tube using plastic transfer pipettes.

Avoid heating at 37 than 5 minutes.

Follow manufacturer’s instructions.

Reconstitute new reagent or open new bottle.

C for longer

Reagent related

Wrong reagent being used.

Reagent related

Incorrect volume of reagent being used.

Reagent related

Reconstitution with incorrect diluent volume.

Reagent related

Reconstitution with other than the recommended diluent.

8-2 EN October 2001

Follow manufacturer’s instructions.

KC4 ∆∆∆∆™

Troubleshooting

Symptoms Possible Causes Corrective Action

(continued)

Controls out of range

Unexpected results.

Reagent related

New lot number of reagent with different reactivity.

Reagent related

Reagent defective due to mishandling in shipping or storage.

Lot-to-lot variation in reagent reactivity is not unusual. Reverify reference range. Prepare new reference curves as appropriate.

First use of reagent in this shipment? Temperature of storage area appropriate?

Reagent related

Reagent deteriorated.

Reagent related

Reagent deteriorated because of extended warming in reagent well.

Reagent related

Reagent contaminated.

Control related

Deteriorated or contaminated control material.

Analytical error

Incorrect incubation time.

Do not use reagent beyond stated reconstituted stability time or beyond expiration date of un-reconstituted reagent.

Do not store reagent on instrument. At the completion of testing, remove reagent from instrument, cap and store according to the manufacturer’s instructions.

Avoid contact of pipette tips with previously pipetted sample or reagent.

Prepare fresh controls

Incorrectly reconstituted control material(s). Reconstitute according to the manufacturer’s instructions. Use only fresh deionized water for reconstitution.

Follow manufacturer’s instructions.

Analytical error

Incorrect reagent temperature.

Analytical error

Incorrect testing sequence.

October 2001 8-3 EN

15 mm tube must be used. No more than 3.5 ml of reagent should be placed in tube. Allow 15–20 minutes for reagent to come to temperature in the reagent well. Some reagents, (Thrombin Reagent for Fibrinogen) should not be warmed but must be equilibrated to room temperature prior to use. Follow reagent manufacturer’s instructions.

Follow manufacturer’s instructions.

KC4 ∆∆∆∆™

Troubleshooting

Symptoms Possible Causes Corrective Action

Erratic within-run test results.

Controls may be in or out of range.

Analytical error

Imprecision in manual pipetting of sample and reagent.

Perform pipette maintenance. A pipette Operating Manual is included in the box of the automatic pipette provided with

∆

the KC4

Practice pipetting technique. Refer to the pipetting section for guidance.

Incorrect dispense position. Consistent location for reagent dispense is important. Refer to Pipetting section for guidance.

Failure to mix particulate reagent prior to use. Cover top of tube with cap or Parafilm and invert gently to mix.

™.



Reagent related

Inconsistent or inaccurate reconstitution of reagent or control material.

Reagent related

Reagent deterioration caused by extended heating in reagent well.

Reagent related

Reagent concentration caused by evaporation.

Failure to mix sample and first reagent. After dispense of sample and reagent, pick the cuvette up and swirl gently 5–6 times to evenly disperse the mixture in the bottom of the cuvette.

Reconstitute new reagent and/ or control material.

Remove reagent from instrument at the completion of testing.

8-4 EN October 2001

KC4 ∆∆∆∆™

Troubleshooting

Symptoms Possible Causes Corrective Action

(continued) Erratic within-run test results.

Controls may be in or out of range.

Sample related

Improper specimen collection and handling.

Sample related

No sample added.

Reagents should be capped when not in use.

Check sample integrity looking for microclots, hemolysis or other irregularities.

Assure that ratio of anticoagulant to sample is correct (full draw).

Draw a new specimen. If erratic results are again obtained, inquire about the clinical condition of the patient. Results on patients in DIC are characteristically erratic.

Observe recommended sample storage conditions.

No clot formation Sample related

Low fibrinogen.

Reagent related

No or incorrect reagent added.

Analytical error

No ball in cuvette.

Clot formed but not detected. Timer does not stop.

Analytical error

Cuvette not seated in well.

Sample related.

Clot formed before 4.6 seconds.

Assure that sample has been added.

A deficiency of Fibrinogen will greatly prolong the results of many coagulation tests.

Assure that correct reagents are being used.

Assure that the ball has not fallen out of the cuvette prior to insertion into measuring well.

Ball is positioned above the sensor. Assure that there are no balls or other obstructing material in the bottom of the well.

If performing Fibrinogen, use next higher dilution.

To stop the timer, insert a new cuvette with ball in the measuring well. After 10 seconds, lift the cuvette out of the well.

Parafilm® is a registered trademark of American Can Company, Greenwich, CT.

October 2001 8-5 EN

KC4 ∆∆∆∆™

APPENDIX

AAPPENDIX

Contents

A.1 INR FAST TRACK................................................................................... A-1

A.2 APTT FAST TRACK ................................................................................ A-2

A.3 FIBRINOGEN FAST TRACK .................................................................... A-3

A.4 FIBRINOGEN CALIBRATION CURVE DILUTION....................................... A-4

A.5 EXTRINSIC FACTORS II, V, VII AND X FAST TRACK............................... A-5

A.6 EXTRINSIC FACTOR STANDARD CURVE DILUTIONS .............................. A-5

A.7 INTRINSIC FACTORS VIII, IX, XI AND XII FAST TRACK ......................... A-7

A.8 INTRINSIC FACTOR STANDARD CURVE DILUTIONS ............................... A-8

October 2001 A-0 EN

KC4 ∆∆∆∆™

APPENDIX

A.1 INR Fast Track

Note: Use the Multipette. See Section 5 for information regarding programming.

↵↵↵↵

1. From the MAIN MENU, press <

2. Press <RUN>.

3. Select Individual Program.

4. Select <INR> and press <

5. Enter Samples per rack (the test must be set up for duplicates; so the count

would be 1 for a single sample or 2 for 2 samples).

↵↵↵↵

Press <

6. Enter Patient ID and press <

7. Warm thromboplastin reagent to 37°C.

8. Place cuvettes into rack positioned in the unheated preparation area.

9. Dispense one ball into each cuvette if not using a Tetravette.

10. Pipette 50 µl sample into bottom of each cuvette.

11. Close flap, remove rack from preparation area and swirl gently 4–5 times.

12. Transfer rack into heated incubation area or into the rotating test positions.

13. Incubate for a minimum of 60 seconds up to a maximum of 180 seconds.

14. Press to prepare Incubation Timers and then press for each channel with

sample in cuvette.

↵↵↵↵

15. Upon completion of incubation Timing for the last well being tested, place rack into rotating test positions, and open Flap.

16. Press <START> and begin dispensing PT reagent into wells. With the Multipette, the timer starts automatically as reagent is dispensed.

17. Record results.

October 2001 A-1 EN

KC4 ∆∆∆∆™

APPENDIX

A.2 APTT Fast Track

Note: Use the Multipette. See Section 5 for information regarding specific

programming.

↵↵↵↵

to 37°C.

incubation time for the test; it is a

1. From the MAIN MENU, press <

2. Press <RUN>.

3. Select Individual Program.

4. Select <APTT> and press <

5. Enter Samples per rack (the test must be set up for duplicates; the count would be

1 for a single sample or 2 for 2 samples). Press <

6. Enter Patient ID and press <

7. Warm APTT reagent and CaCl

8. Place cuvettes into rack positioned in the unheated preparation area.

9. Dispense one ball into each cuvette if not using a Tetravette.

10. Pipette 50 µl sample into bottom of each cuvette.

11. Close flap, remove rack from preparation area, and swirl 4–5 times.

12. Transfer rack to heated incubation area or into the rotating test positions.

13. Incubate for 240 seconds (This is the TOTAL combination of the sample warm-up plus the warming of the APTT reagent).

↵↵↵↵

14. Press to prepare Incubation Timers and then press for each channel with sample in cuvette.

15. At 185 seconds add 50 µl APTT reagent.

16. Upon completion of incubation Timing for the last well being tested, place rack into rotating test positions, and open flap.

17. Press <START>. Begin dispensing 50 µl CaCl measurement timing begins automatically.

18. Record results.

into cuvettes. Using the Multipette,

A-2 EN October 2001

KC4 ∆∆∆∆™

APPENDIX

A.3 FIBRINOGEN Fast Track

Note: Use the Multipette. See Section 5 for information regarding programming.

↵↵↵↵

1. From the MAIN MENU, press <

2. Press <RUN>.

3. Select Individual Program.

4. Select <FIB> and press <

5. Enter Samples per rack (the test must be set up for duplicates; the count would be

1 for a single sample or 2 for 2 samples).

↵↵↵↵

Press <

6. Enter Patient ID and press <

7. Warm Thrombin Reagent to room temperature (18–25°C).

8. Prepare 1:10 sample dilutions.

9. Dispense one ball into each cuvette if not using a Tetravette.

10. Pipette 100 µl diluted sample (patient test plasmas are prepared by diluting plasma 1:10 with Imidazole Buffer*) into bottom of each cuvette.

11. Close flap, remove rack from preparation area and swirl gently 4–5 times.

12. Transfer rack into heated incubation area or into the rotating test positions.

13. Incubate for a minimum of 60 seconds and up to a mzximum of 180 seconds.

↵↵↵↵

14. Press to prepare Incubation Timers and then press for each channel with sample in cuvette.

15. Upon completion of incubation timing for the last well being tested place rack into rotating test positins, and open flap.

16. Press <START> and begin dispensing 100 µl Thrombin Reagent into each well. Using the Multipette, the timer starts automatically as reagent is dispensed.

17. Record results.

*Refer to test application.

October 2001 A-3 EN

KC4 ∆∆∆∆™

APPENDIX

A.4 FIBRINOGEN CALIBRATION CURVE DILUTION

Fibrinogen Reference Buffer

Dilution (ml) (ml) Dilution Factor

1:7 0.1 0.6 1.43

1:8 0.1 0.7 1.25

1:10 0.1 0.9 1

1:20 0.1 1.9 0.5

1:25 0.1 2.4 0.4

1:30 0.1 2.9 0.33

1:40 0.1 3.9 0.25

A-4 EN October 2001

KC4 ∆∆∆∆™

APPENDIX

A.5 EXTRINSIC FACTORS II, V, VII and X FAST TRACK

Note: Use the Multipette. See Section 5 for information regarding programming.

1. From the MAIN MENU, press <

2. Press <RUN>.

3. Select Individual Program.

4. Select <FAC> and press <

5. Enter Samples per rack (the test must be set up for duplicates; the count would be 1 for a single sample or 2 for 2 samples).

↵↵↵↵

Press <

6. Enter Patient ID and press <

7. Warm thromboplastin Reagent to 37°C.

8. Prepare 1:10 sample dilutions.

9. Dispense one ball into each cuvette if not using a Tetravette.

10. Pipette 50 µl diluted sample (patient test plasmas are prepared by diluting plasma 1:10 with Imidazole Buffer)* into bottom of each cuvette.

11. Add 50 µl appropriate Factor Deficient Plasma.

12. Close flap, remove rack from preparation area and swirl gently 4–5 times.

13. Transfer rack into heated incubation area or into the rotating test positions.

14. Incubate for a minimum of 60 seconds and up to a maximum of 180 seconds.

↵↵↵↵

15. Press to prepare Incubation Timers and then press for each channel with sample in cuvette.

16. Upon completion of incubation timing for the last well being tested, place rack into rotating test positions, and open flap.

17. Press <START> and begin dispensing 100 µl thromboplastin into each well. Using the Multipette, the timer starts automatically as reagent is dispensed.

18. Record results.

* Refer to test application.

October 2001 A-5 EN

KC4 ∆∆∆∆™

APPENDIX

A.6 EXTRINSIC FACTOR STANDARD CURVE DILUTIONS

Reference

Dilution

1:10 0.2 1.8 1 1:20 1.0 of 1:10 1.0 0.5 1:40 1.0 of 1:20 1.0 0.25 1:80 1.0 of 1:40 1.0 0.125 1:160 1.0 of 1:80 1.0 0.0625

Plasma (ml) Buffer (ml) Dilution Factor

A-6 EN October 2001

KC4 ∆∆∆∆™

APPENDIX

A.7 INTRINSIC FACTORS VIII, IX, XI and XII FAST TRACK

Note: Use the Multipette. See Section 5 for information regarding programming.

↵↵↵↵

to 37°C.

1. From the MAIN MENU, press <

2. Press <RUN>.

3. Select Individual Program.

4. Select <FAC> and press <

5. Enter Samples per rack (the test must be set up for duplicates; the count would be 1 for a single sample or 2 for 2 samples).

↵↵↵↵

Press <

6. Enter Patient ID and press <

7. Warm APTT reagent and CaCl

8. Prepare 1:5 sample dilutions.

9. Place cuvettes into rack positioned in the unheated preparation area.

10. Dispense one ball into each cuvette if not using a Tetravette.

11. Pipette 50 µl diluted sample (patient test plasmas are prepared by diluting plasma 1:10 with Imidazole Buffer)* into bottom of each cuvette.

12. Add 50 µl appropriate Factor Deficient Plasma.

13. Close flap, remove rack from preparation area and swirl gently 4–5 times.

14. Transfer rack into heated incubation area or into the rotating test positions.

15. Incubate for 240 seconds (This is the TOTAL combination of the sample warm-up plus the warming of the APTT reagent).

16. Press to prepare Incubation Timers and then press for each channel with sample in cuvette.

17.

At 185 seconds add 50 µl APTT reagent.

18. Upon completion of incubation timing for the last well being tested, place rack into rotating test positions, and open flap.

19. Press <START>. Begin dispensing measurement timing begins automatically.

20. Record results.

* Refer to test application

October 2001 A-7 EN

µµµµ

CaCl

incubation time for the test, a

into cuvettes. Using the Multipette,

KC4 ∆∆∆∆™

APPENDIX

A.8 INTRINSIC FACTOR STANDARD CURVE DILUTIONS

Dilution Reference Plasma (ml) Buffer (ml) Dilution Factor

1:5 0.4 1.6 1

1:10 1.0 of 1:5 1.0 0.5

1:20 1.0 of 1:10 1.0 0.25

1:40 1.0 of 1:20 1.0 0.125

1:80 1.0 of 1:40 1.0 0.0625

A-8 EN October 2001

Sigma Amelung KC4 Delta User manual

Specifications and Main Features

Frequently Asked Questions

User Manual