2.1 Brief Description of the Operational Characteristics of the
AMAX CS-190
• The AMAX CS-190 is a fully automated coagulation instrument.
• The AMAX CS-190 is used for measuring the in-
vitro coagulation times. Both plasma and whole
blood samples can be used.
• The instrument features an optical and a
mechanical measuring unit.
• In addition to the clotting tests, chromogenic
(kinetic) tests can be carried out by using the
optical measuring unit.
• The measured results can be converted to concentration or activity data with the
help of storable standard curves.
5.5
6.
5.5
2
• The PC identifies and stores patient samples and data.
• The samples are aspirated from their primary
containers with a needle by way of the XYZZrobot probe. Then the samples are mixed in a
measuring cuvette with either a reagent and/or a
buffer. After that the samples are incubated in the
incubation rail (12 incubation slots).
• At the end of the incubation period, the XYZZrobot moves the cuvette into the optical or
mechanical measuring unit.
8.6
8.3
8.6
6.1
6.2
6.3
• After the addition of the starting reagent by the XYZZ-robot, the coagulation time is
measured.
• Reagents, volumina and incubation periods can be programmed individually.
• Measured results and their calculations can be printed out in a protocol and stored
simultaneously in the PC’s patient archive.
• In addition, the results can be transferred to an external EDP (laboratory EDP) via
bidirectonial data transfer.
June, 98 2 – 1
2
Introduction
2.2 Traffic Lights
The traffic lights are positioned in the upper, right corner of the AMAX CS-190 next to
the dilutor unit (user position in front of the instrument). The light signals have the
following meanings:
Tab. 2.2.1
Light signal Meaning
no light
green light
yellow light WARNING: missing cuvettes, waste water reservoir full, fresh
red light ERROR: temperature outside operating range, photometer lamp
green + red light ERROR: XYZZ - waste water well full
running light CANCEL: press any key - Instrument is aborting current process.
AMAX CS-190 software booted, no errors registered, processing
not yet started.
AMAX CS-190 software booted, no errors registered, processing
started
water reservoir empty, plasma-reagent-tray cover open,
photometer lamp switched off
not yet ready
2.3 Pictograms
This service manual describes the maintenance and repair of the automatic coagulation
instrument AMAX CS-190.
These instructions are written for qualified medical and technical personnel.
IMPORTANT!
Read these instructions carefully and work only in the prescribed
manner!
Pay attention to warnings and notices!
Only in this way can damage to man and machine be avoided!
2 – 2 June, 98
Introduction
To increase the overall understanding of this manual, the following pictograms are
used:
ATTENTION!
There is DANGER TO LIFE of the user!
Read these instructions carefully and work only in the prescribed
manner!
Pay attention to warnings and notices!
Only in this way can damage to man and machine be avoided!
2
ATTENTION!
The AMAX CS-190 can be damaged!
Read these instructions carefully and work only in the prescribed
manner!
Pay attention to warnings and notices!
Only in this way can damage to man and machine be avoided!
IMPORTANT / NOTICE!
Requires additional operator action
or alteration of the adjustment parameters.
also see chapter
#
one turn to the ‘right’ (clockwise)
one turn to the ‘left’ (anti clockwise)
Amelung specific part number
1¬
1«
(Q00000)
Key on the PC-keyboard
June, 98 2 – 3
<X>
Safety Regulations
3. Safety Regulations
3
3.1 Information on How to Avoid Danger to Life and
Health
3.1.1 General Information
3.1.2 Information on the Repair of the AMAX CS-190
3 – 1
3 – 1
3 – 1
June, 98 3 – 0
Safety Regulations
3
It is guaranteed that the user is protected from danger to life and health
when using the AMAX CS-190 in compliance with the regulations (§ 3(1)
MedGV).
3.1 Information on How to Avoid Danger to Life and Health
3.1.1 General Information
• If the AMAX CS-190 shows any defects which might endanger patients or user
personnel, it must not be operated (§ 6(1) MedGV).
• Wear protective clothing, especially protective gloves. It is a possibility that infected
plasma (dangerous substances) might be touched.
• Protective clothing, especially protective gloves which were in contact with
dangerous substances (e.g. infected plasma) have to be changed and disposed
immediately (Technical rules for dangerous Substances (TRGS)).
• Plasma samples, reagents and waste water are toxic waste. The toxic waste has to
be disposed in compliance with the operative regulations (laboratory regulations).
3.1.2 Information on the Repair of the AMAX CS-190
• While under repair the instrument must not be used for testing.
• After a repair, the AMAX CS-190 has to undergo a functionality check. This involves
the carrying out of checking measurements. These actual values have to be
equivalent to the theoretical values.
ATTENTION!
Live parts (power unit and connection panel) must not be
touched!
DANGER TO LIFE!
ATTENTION!
On certain parts (photometer lamp or lamp casing) there is a
DANGER OF BURNS!
IMPORTANT!
Regular maintenance helps to avoid malfunctions and protects
the AMAX CS-190 from damage.
June, 98 3 – 1
Accessories / Equipment
4. Accessories / Equipment
4.1 Measurement and Adjustment Tools for Repairs 4 – 1
4
June, 98 4 – 0
Accessories / Equipment
4
4.1 Measurement and Adjustment Tools for Repairs
It is recommended to always carry the following tools and adjustment gauges at every
AMAX CS-190 service intervention:
Tab. 4.1.1
Measuring instruments / Tools Catalog no.
Thermometer 121563
Surface probe 121565
Immersion probe 121564
Digital multimeter
Oscilloscope incl. probes: 1:1 / 1:10
Adjustment gauge I (magazine light barriers) J01847
Adjustment gauge II (row pusher end light barrier) J01827
Adjustment gauge III (adjustment gauge lifting solenoid) J01819
Adjustment gauge (alignment pusher 1 unit) J01820
Needle ejector tool J01818
Spring balance 890300
Adjustment tool auto photometer height J01817
June, 98 4 – 1
Technical Data
5. Technical Data
5
5.1 Measurements
5.2 Weights
5.3 Electrical Connection Data
5.4 Temperatures
5.4.1 Temperatures of the Individual Modules
5.5 Intended Use
5.6 Throughput of the AMAX CS-190
5 – 1
5 – 2
5 – 2
5 – 3
5 – 3
5 – 4
5 – 5
June, 98 5 – 0
Technical Data
5.1 Measurements
5
AMAX CS-190
• Height
• Width
• Depth
Commander PC
• Height
• Width
• Depth
Monitor (14 inches)
• Height
• Width
• Depth
optional: Monitor (15 inches)
ca. 56 cm ( 22.5 inches)
ca. 82 cm (32.75 inches)
ca. 69 cm (27.75 inches)
ca. 12 cm ( 4.75 inches)
ca. 40 cm ( 16 inches)
ca. 44 cm (17.75 inches)
ca. 37 cm ( 15 inches)
ca. 35 cm ( 14 inches)
ca. 39 cm (15.75 inches)
• Height
• Width
• Depth
Keyboard
• Height
• Width
• Depth
Printer
• Height
• Width
• Depth
Base cabinet for the AMAX CS-190
• Height
• Width
• Depth
ca. 39 cm (15.75 inches)
ca. 39 cm (15.75 inches)
ca. 36 cm ( 14.5 inches)
ca. 4 cm ( 1.5 inches)
ca. 46 cm ( 18.5 inches)
ca. 17 cm ( 6.75 inches)
ca. 17 cm ( 6.75 inches)
ca. 36 cm ( 14.5 inches)
ca. 21 cm ( 8.5 inches)
ca. 71 cm (28.25 inches)
ca. 82 cm (32.75 inches)
ca. 69 cm (27.75 inches)
June, 98 5 – 1
5
5.2 Weights
Technical Data
• AMAX CS-190
• Base cabinet for AMAX CS-190
• Commander PC
• Monitor
• Printer
ca. 130 kg ( 286 pounds)
ca. 78 kg ( 172 pounds)
ca. 10 kg ( 22 pounds)
ca. 11 kg (24.2 pounds)
ca. 2,5 kg ( 5.5 pounds)
5.3 Electrical Connection Data
AMAX CS-190
• supply voltage
• supply frequency
• power consumption cold, max:
warm, min:
• heat emission
Commander PC
90-132 /
180-265
47-63 Hz
1240 kJ/h
VAC
690
230 VAVA
• supply voltage
• supply frequency
• power consumption
Monitor
• supply voltage
• supply frequency
• power consumption
Printer
• supply voltage
• supply frequency
• power consumption
90-132 /
180-264
50-60 Hz
145 VA
100-240 VAC
47-63 Hz
80 VA
230 VAC
50 Hz
30 VA
VAC
5 – 2 June, 98
Technical Data
5
5.4 Temperatures
The internal components of the Amelung Amax CS-190 are heated or cooled
automatically. In order to guarantee the perfect performance of the AMAX CS-190, the
following instructions have to be followed:
• The AMAX CS-190 must not be placed directly in front of a wall.
(minimum distance 15 cm)
• The ventilation grids must never be obstructed in any way.
(Cooling the AMAX CS-190 would be impossible)
• The system fluid supply has to be sufficient at all
times.
• To provide a sufficient air flow, the air filter has to
be clean.
• Do not expose the AMAX CS-190 to direct sunshine. The room temperature must
not exceed 32°C.
9.1
9.2
ATTENTION!
Disregard may lead to malfunction of and cause damage to the
AMAX CS-190!
5.4.1 Temperatures of the Individual Modules
• reagent plasma barcode tray ca. 16.5 ± 1.5°C
• incubation rail ca. 37.5 ± 0.3°C
• optical measuring unit ca. 37.5 ± 0.3°C
• mechanical measuring unit ca. 37.5 ± 0.3°C
• cuvette magazine ca. 37.5 ± 0.3°C
• pre-heater ca. 40.0 ± 0.5°C
• cooling water system ca. 25 - 55°C
• warm water circuit (37°C)
washing in the well ca. 38.5 ± 0.5°C
pumping in the well ca. 38.5 ± 0.5°C
The temperature in the well is measured by a liquid thermometer.
In the user software
is measured during the process “Wash” and “Fill”.
The warning limits for the temperatures can be entered in the user interface software.
(main menu), select “Maintenance”, then “Wash”. The temperature
In the case of a divergence, a message will be
displayed on the monitor and the status lights will
June, 98 5 – 3
2.2
5
show yellow.
In addition, an acoustic signal will sound and the AMAX CS-190 will not reactivate.
Technical Data
5.5 Intended Use
The AMAX CS-190 measures in-vitro coagulation times and chromogenic test
reactions. Both citrated whole blood and citrated plasma samples can be used.
You can choose between the mechanical measuring and the optical measuring mode.
Depending on the used reagents and measuring methods the following hemostasis
parameters can be determined:
• Prothrombin time (PT/Quick)
• Hepato-Quick
• Activated Partial Thromboplastin Time (APTT)
• Thrombin time (TT)
• Fibrinogen (Clauss)
• Fibrinogen (derived, optical density measurement)
• Normotest
• Thrombotest
• Factor assays: II, V, VII, VIII, IX, X, XI and XII
• AT III
• Plasminogen
• Antiplasmin
• PAI
• Heparin
• Protein S
• Protein C
• APC-Resistance
• and more
5 – 4 June, 98
Technical Data
5
5.6 Throughput of the AMAX CS-190
The throughput of the AMAX CS-190 is influenced by the type of measuring method
used.
The AMAX CS-190 features a mechanical and an optical measuring unit.
The mechanical measuring unit has 4 measuring cells which work with theballmethod.
The optical measuring unit (photometer) has 4 measuring channels for measurement of
the optical density. The wavelength of the light is 405nm.
The necessary total volumes for the measurements are:
• Mechanical measuring mode,
• Optical measuring mode
• Maximum volume (mechanical, optical): 600µl
The individual measuring modes are described on the following pages.
minimum volume: 75µl
, minimum volume: 150µl
6
6.1 Mechanical Measuring Mode
The time between the addition of the starting reagentand the beginning of the
formation of fibrin is measured.
The sample and if necessary the reagent and/or buffer are pipetted into a measuring
cuvette. After the incubation time it is placed into one of the mechanical measuring
channels automatically.
There is a special steel ball on the bottom of the cuvette.
With the addition of the starting reagent, the cuvette starts to rotate around its
longitudinal axes while the ball is held in a certain position by a magnet.
As coagulation begins, the ball is removed from its position by the forming fibrin
threads, because the force of the magnet is overcome. A sensor detects the change of
the ball’s position and ends time measurement.
Pic. 6.1.1
schematic display of the
mechanical measuring mode
cuvette
sensor
magnet
June, 98 6 – 1
6
A
Measuring Methods
Impulse measurement
In order to detect very unstable clots with the mechanical method, the continuous
rotation of the cuvette can be changed to a rotation with intervals after a predefined
time.
In the example on Pic 6.1.2, the continuous movement is switched to interval
movement after 25.6s. During the intervals, which prolong automatically, a clot cannot
be detected, but it has time to stabilise itself. The CV rises in dependence with the
length of the interval.
Pic. 6.1.2
Impulse measurement
Cuvette
rotates
Cuvette
stops
dd ition s tarting
reagent
activation
4s
Begin of
impulsemovement
25 .6 s
Movement:
½ rotation
pause
0.2s
pause
+0.1s
pause
+0.2s
pause
+0.3s
pause
+0.4s
6 – 2 June, 98
[s]
t
Measuring Methods
6
6.2 Optical Measuring Mode (Clotting)
The time between the addition of the starting reagentand the beginning of the
formation of fibrin is measured.
The sample and if necessary the reagent and/or buffer are pipetted into a measuring
cuvette. After the incubation time it is placed into one of the optical measuring channels
automatically.
The timing begins with the addition of the starting reagent. The intensity of the light
beam that passes through the cuvette is monitored by a sensor. When clots are
forming, the sample/reagent mixture becomes cloudy and the intensity of the light
reaching the sensor decreases (turbidimetrical measurement).
As soon as the change in the optical density reaches a pre-set threshold, the time
measurement stops.
Pic. 6.2.1 schematic display of the optical measurement (clotting)
Pic. 6.2.2
Analysis of the optical measurement (clotting)
mE
The coagulation time t2 is the time taken
from addition of the starting reagent to the
point when the absorbance change has
30
15mE
20
0
E
1-E
achieved the predefined threshold value.
The absorbance change is measured from
the stable baseline value at E
0.
Example: 15mE (threshold value).
10
0
E
The derived fibrinogen is calculated from
102030
lag-
1
phase
Coag. time
t
t
2
the difference between the maximum
absorbance E
1 and the baseline value E0.
June, 98 6 – 3
6
Measuring Methods
6.3 Optical Measuring Mode (Chromogenic)
The rate of absorbance change is measured at predetermined intervals.
Sample and reagent are pipetted into a measuring cuvette and placed into one of the
optical measuring channels. After the addition of the starting reagent, measurements
are taken in defined intervals.
A monochrome light beam (405nm) passes through the cuvette. The change in optical
density is measured by a sensor behind the cuvette at pre-defined intervals (kinetic
measurement).
The values of change in mE/t are further mathematically processed.
Pic. 6.3.1 schematic display of the optical measurement (chromogenic)
1. Remove the packaging material of the AMAX CS-190 and level the instrument on
the base cabinet.
Fasten the connecting bolts which connect the base cabinet and the instrument.
2. Do not turn on the instrument yet!
All movable parts were secured for transport.
(XYZZ-robot: all axes were secured)
Remove all shipping clamps.
(check driving belt XY-axes, tapes, paper boards, etc.)
Check all movable parts for free movement.
3. Check the system coolant level,
if necessary fill up with original system liquid.
(830040 (500ml bottle)).
4. Configure PC & Accessories.
5. Connect the fresh/waste water reservoir and the
liquid level sensors.
6. Establish all electrical connections between the
PC and the AMAX CS-190.
7. Now the AMAX CS-190 can be turned on.
7 – 2 June, 98
9.1
7.3
7.5
7.6
Instrument Installation
ATTENTION!
Remove all shipping clamps and securing devices before turning
on the instrument.
Disregard may lead to malfunction of and cause damage to the
AMAX CS-190!
Packaging material is recycable!
7.3 PC & Accessories
7
1. Remove all packaging material of the PC, monitor, printer, etc.
In case the AML-Bus-Board (Board PH-PC (D02801)) or the modem board (Z04005)
have not yet been installed, the PC has to be opened and the boards have to be
placed into free slots.
Check and correct the jumper settings (see below) before the installation. Disregard
may lead to malfunction or conflicts with other components.
2. Connect all components (except for the PC and the AMAX CS-190!) and establish
all electrical connections.
3. Install the software:
First, switch on the PC, screen and printer. The PC installs its operating system
automatically (selection: WINDOWS 3.1) After approx. 30 min. the installation is
complete and you can continue by yourself. Deinstall WINDOWS with only the DOS prompt remaining on the hard drive.
Now the main software can be installed.
It consists of three or five 3,5” disks:
a. Disk with main menu AMAX CS-190
b. Disk for service software
c. Disk for AMAX CS-190 (instrument specific data)
d. Disk for modem software (option)
e. Disk for printer driver
(printer specific)
7.4
June, 98 7 – 3
7
7.3.1 Jumper Settings on the AML-BUS-PC-Board
There are two dip-switches on the Board PH-PC for adjusting the address.
The following switch adjustments have to be made so that the board can be identified:
Tab. 7.3.1
Dip-switch S1PositionDip-switch S2Position
Switch 1 on Switch 1 on
Switch 2 on Switch 2 off
Switch 3 on Switch 3 off
Switch 4 off Switch 4 off
ATTENTION!
Disregard may lead to malfunction of the AMAX CS-190!
Instrument Installation
7.3.2 Jumper Settings of the Modem Boards
The different modems are not distinguishable by their names. For their differentiation,
the BZT-No. is used here. This BZT-No. is printed on the packaging and on a label on
the modem itself.
Tab. 7.3.2
Designation Switch position for Com 3 IRQ 5
Internal fax-modem BZT-No.
(Company)
BZT - No. A109 822D
BZT - No. A107 434D
(YAKUMO)
BZT - No . A121 250F
(CREATIX)
BZT - No. A106 901D
The initialisation string for these modems is:
ATE0Q0V0L1X3%C1\N3\V1S0=2S7=100^M
2 and 7 (7 is a soldering bridge)
switch 1 and 6 to ON
all others to Off
switch 1 and 6 to ON
all others to Off
2,3,8
ATTENTION!
Disregard may lead to malfunction of the AMAX CS-190!
7 – 4 June, 98
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