Sigma Amelung KC4 Delta User manual
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)
© 2001 Sigma-Aldrich Co.
October 2001 EN
™ User Manual, October 2001
∆
KC4 ∆∆∆∆™
0
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 ∆∆∆∆™
0
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 ∆∆∆∆™
1
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 ∆∆∆∆™
1
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
1
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 ∆∆∆∆™
1
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 ∆∆∆∆™
1
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 ∆∆∆∆™
1
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 ∆∆∆∆™
1
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
1.6 Front View (Figure 1)
1
3
4
1
2
Item Function or Description
1. Rack Used for transferring cuvettes from
preparation area to reaction incubation
wells and rotating test positions.
5
6
7
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
1
KC4 ∆∆∆∆™
Introduction
1.7 Keypad (Figure 2)
2
12 3 4 4 4 45
12
6
11
10
8
Item Function or Description
97
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.
↵↵↵↵
9.
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
1.8 Back View (Figure 3)
3
2. 1.
Item Function or Description
3.
4.
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
1
KC4 ∆∆∆∆™
Introduction
1.9 Multipette (Figure 4 A & B)
4
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
1.10 Ball Dispenser (Figure 5)
5
Item Description or Function
1. Dispenser For loading microballs into cuvettes
1.11 Thermal Printer (Figure 6)
6
October 2001 1-11 EN
1
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 ∆∆∆∆™
2
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
2
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
µ
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
µ
l, 10 trays
∆
™ Tetravettes
13. K0633 KC Pittette Tube Sleeves
October 2001 2-1 EN
KC4 ∆∆∆∆™
2
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 ∆∆∆∆™
2
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
2
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 ∆∆∆∆™
3
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
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