Beruflich Dokumente
Kultur Dokumente
USERS MANUAL
Software ver. 1.1
SEAC S.R.L.
Via di Prato, 72/74 - Calenzano - Firenze
Tel:(055) 8877469 - Fax:(055) 8877771
Cod. 53872211
INDEX
1.
2.
3.
USE .......................................................................................................................... 28
3.1. Start-up ..................................................................................................................28
3.2. Main menu ............................................................................................................. 28
3.3. Testing ...................................................................................................................29
3.3.1. Test selection................................................................................................... 29
3.3.2. Calibration........................................................................................................ 29
3.3.3. Determinations................................................................................................. 33
3.3.4. Results ............................................................................................................. 34
4.
INDEX OF FIGURES
Your suggestions, advice and criticisms would be very welcome and useful for improving our
product. We would, therefore, be grateful if you could answer the following questions:
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Have you found this manual easy to understand and follow? Please, indicate your
impressions:
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Have you found any errors in the instructions? If so, please indicate the paragraph and
page:
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COMPANY NAME .......
NAME AND SURNAME ................
ADDRESS .
TELEPHONE .................................................................... DATE ..............................................
Please, return this form to:
SEAC S.R.L. - Via di Prato, 72/74 - 50041 Calenzano (FI).
Tel 055/8877469 Fax 055/887771
Thank you for your cooperation.
7
I. STATEMENT OF LIABILITY
Our Company declines all responsibility for damage due to any type of modifications made on
the Hardware or Software and for damage due to connection with other instruments not
carried out by our personnel or previously authorized.
In the event of the device being damaged, do not switch it on until it has been repaired by our
personnel.
All operations of an electrical nature required for installing or repairing the instrument must be
carried out by our personnel; avoid all other types of installation.
The instrument must be installed in a suitable environment, as described at points II and III of
this chapter, so as to censure that its performance complies with the values given in the
technical specifications.
Make sure that power is supplies at the required voltage before switching the instrument
on.
The instrument must have a ground connection. Should a line short circuit occur, ground
connection will eliminate the risk for the external metal parts of the tool to be powered at
the voltage supplied.
In the event of over-absorption (due to a short circuit or another malfunction within the
instrument or due to sudden line voltage variation), the protection fuse located on the
back will be operated; in this case, if the new fuse burns out again after having replaced it
with another of the same kind, disconnect the instrument and contact the Technical
Support staff.
Do not use the commands or adjustments inside the instrument and notify the service
staff as soon as any anomaly occurs during operation.
Before starting any type of action inside the device, switch it off (move the power button
onto O) and disconnect the power cord. To do this, grab the plug but never pull the
cable directly.
Refer all installation operations that involve powered parts to specifically qualified staff.
If the device is damaged, do not start it until it has been repaired by a qualified member of
the Technical Support Service.
Disconnect the device if you are not going to use it for long periods of time.
Power Supply
Power Requirement
83 VA
Line Fuse
T 1A L
TABLE OF SYMBOLS
Number
Symbol
Description
Alternating current
Ground terminal
On (power)
Off (power)
Fuse
EC mark
10
1.
GENERAL DESCRIPTION
1.1.
FOREWORD
The device can carry out the following tests: PT, APTT, Fibrinogen, TT, Coagulation
Factors and tests showing clot forming.
The device is provided with two independent reading channels with a magnetic agitator
and a thermostat compartment for sample and reagent incubation.
It allows for four different standard calibrations, and calibration curves can be stored in
the memory and printed.
When the reagent/plasma (starter) is dispensed, the device automatically starts the
count and stops it when the clot is formed.
Results are shown on the liquid crystal display and printed on the thermal matrix printer.
11
1.2.
TECHNICAL FEATURES
Measurement principle
Photometry
Light source
950 nm LED
Reading channels
Determinations
Repeatibility
PT
Fibrinogen
C.V. = 1,8%
C.V. = 2,6%
Thermostat
Number of positions
Incubation
37C 1C
Heating time: from 25 to 37C less than 15 minutes
Keyboard
Display
Printer
Host connection
RS232
192
points
per
line,
for
12
General features
Power supply
Power Requirement
83 VA
Line Fuse
T 1A L
Operating Conditions
Temperature
Relative Humidity
20 80 % (during operation)
0 90 % (when off)
Altitude
Environmental coefficient :
Safety
Electromagnetic
Compatibility
Dimensions
30 x 30 x 36 (h) cm
Weight
8 Kg
13
1.3.
OPERATING PRINCIPLE
Figure 1.1 shows the diagram of the operating principle of the coagulometer, which can be
detailed as follows:
Reading cell, including the photodetector (3), the photometer (9) and the test tube (1)
introduced by the operator, which contains the sample to be tested.
Magnetic capitan agitator, including a motor (5), a magnet (4) and the armature (2) that
is placed in the test tube and moved by magnetic drive.
14
15
1.4.
DESCRIPTION OF DEVICES
16
Thermostat
The thermostat compartment includes:
30 positions for sample incubation (3)
2 positions for reagent (2)
2 independent reading positions with a magnetic agitator (1)
Printer
The graphic printer can be used to print the following data:
the results expressed in the preset measurement units
test parameters
calibration curves
system settings
17
Keyboard
It has 9 alphanumeric keys (1 9) and the following keys: CL, O/No, ./Yes, reset1, reset2,
timer1, timer2, print, feed, enter, stop.
:A
:B
:C
:b
:c
:1
(space), +, /,
18
Keys
Function
:
Cancels Last type pressing (preset parameter), provided that you have
not pressed Enter before.
0/No
Reset1
Reset2
Timer1
It enables and disables the timer of channel 1 used for the incubation
time preset for the test selected.
Timer2
Feed
Paper feeding
Enter
Stop
It stops the ongoing operation. The device goes back to the previous
menu.
If pressed during the recording of a platelet aggregation plot, it stops the
recording.
CL
/Yes
19
Back panel
20
1.5.
5-Signal Ground
7-Signal Ground
5-Signal Ground
5-Signal Ground
Transmission features
Transmission format
Baud rate = Programmable
Data Bits = 8
21
Stop Bits
Parity
= 1
= None
The CLOT 2S sends the data to the Host Computer in XML 1.0. format. The transmission
software uses the set of ASCII characters standard . The data transmission is carried out at
the end of each measurement.
Dati
Int
Uint
float
Date
string
Description
Integer with sign
Integer without sign
Number in floating point
date expressed in the DD/MM/YY format
Sequence of ASCII characters
TAG
Description
<CLOT2S>...</CLOT2S>
<TEST>...</TEST>
<CALIB>...</CALIB>
<STD>...</STD>
<SMP>...</SMP>
<ID> Uint </ID>
<NAME>string</NAME>
<DATE>date</DATE>
<CHANNEL> Uint </CHANNEL>
<CNT> Uint </CNT>
<IDSTRING>string</IDSTRING>
<TIME>float</TIME>
<RATIO>float</RATIO>
<INR>float</INR>
<ACTIVITY>float</ACTIVITY>
<CONC>float</CONC>
<UNIT>string</UNIT>
<OVERSTD>
<UNDERSTD>
22
1.6.
1.6.3. PROTECTION
Electronic components may cause electric shock and injury. Do not remove
covers or doors if not specifically recommended in this manual.
The use of clinical samples involves an important biological risk and must
therefore be carried out with the utmost caution.
The instrument is designed to censure maximum protection of the user during
normal operation.
23
2.
2.1.
FOREWORD
The instrument must be supplied with 115 / 230 VAC and 50 60 Hz voltage.
Make sure that the voltage selected corresponds to the mains voltage by using the
voltage switch located on the back panel.
2.2.
There are certain precautions to keep in mind during transportation, storage and unpacking of
the instrument in order to avoid damages also due to storage in an improper environment.
TRANSPORTATION
The instrument weighs about 10 kg when packed, 8 kg when not packed; its size is 48 x 42 x
43 (h) cm with the packaging, 30 x 30 x 36 (h) without packaging.
Therefore, no special equipment is needed for transportation, loading and unloading of the
device box.
The box should be handled in compliance with the recommendations indicated on the outer
surface (UP-DOWN).
STORAGE
The equipment should be stored in its original packaging, consisting in a box, and according
to the specific recommendations written on the outer side (UP-DOWN).
If the packaging has been damaged during storage or transportation, first check that the
device has not been clearly damaged: if so, restore the packaging before storage.
24
UNPACKING
Unpacking operations are very simple: Unpack the device with care; Do not throw the
packaging, as the device might need to be shipped again in the future; Remove the device
from the packaging keeping it in a vertical position;
Q.ty
Description
Code
29800410
T 1A L fuse
29000021
72040350
Users Manual
53872211
Plastic cover
52040510
72040022/10
25
2.3.
DEVICE INSTALLATION
Operative requirements are the priority in the selection of the room/environment where the
device should be installed. The overall dimensions of the coagulometer are 30 x 30 x 36 (h)
cm, but sufficient space should be left all around the device to facilitate access for
maintenance operations.
The primary activities needed to install the device are:
Although the coagulometer has been designed with such components as to ensure safe
operation even in unfavorable conditions, check that the installation environment has the best
possible conditions to favour the most reliable performance.
High temperatures speed up the ageing process of components, and may cause
temporary or even permanent changes to them.
A particular dusty environment may cause an abrasive action on the components and
therefore reduce their life.
High frequency and high intensity pulses generated in the electric lines or induced by the
surrounding environment may cause measurement errors.
Do not install the instrument near any heat source such as radiators, hot air pipes or
places directly exposed to sun light.
The installation room must be provided with a power supply outlet with the following
characteristics:
26
Distribution
Power Supply
Power Requirement
: 83 VA
A 3-wire cable with a 3-contact outlet is supplied together with the device for connection to the
mains and grounding system. Never connect the instrument to an ungrounded outlet.
A grounding system non built according to workmanlike standards may imply dangers for the
operator.
Environmental characteristics of the installation room
Temperature
Relative Humidity
: 20 80 % (on)
0 90 % (off)
Altitude
27
3.
USE
3.1.
START-UP
Turn the device on by using the ON/OFF switch located on the back panel. The device will
carry out a number of checks and inform the user of any anomaly. At the end of start-up you
will be requested to enter the current date. Enter 2-digit day, month and year and then press
enter. If you press enter without entering the date, the date will not be printed on the analyzer
report and the main menu will be displayed. Before any reading, wait unit the thermostat has
reached the temperature of 37C: this means that from a room temperature of 25C, you will
wait for about 15 minutes.
3.2.
MAIN MENU
The main menu shows the four basic functions of the device.
1 :
T e s t
2 :
P r o g r a m m i n g
3 :
U t
4 :
A g g r e g a t
e x e c u t i
o n
i e s
i o n
r e c .
You can choose the function desired by selecting 1, 2, 3 or 4. The general features of each
function are:
1: Testing
When you select this function, the device carried out the measurements according to the
parameters preset during programming (paragraph 3.4.1).
2. Programming
This function allows a new test to be carried out or a stored test to be changed or cancelled.
The device has a memory capacity of 99 tests (ID from 1 to 99), which are programmed by
the operator when answering the computers questions. The data entered are checked at
each answer provided. At the end of programming, you can obtain a print of the test entered
by simply pressing Print.
28
3. Utilities
Use this function by selecting Photomer Calib. to check the amplitude (Volt) of the
photometric signal of the two reading channels. Select Settings to check and set the general
device options (paragraph 3.5.2).
4. Platelet aggregation recorder
This function allows the device to record the platelet aggregation plot.
3.3.
TESTING
3.3.1. TEST SELECTION
From the main menu, press (1) and you will be required to enter the code number of the test
to be carried out, through the display of the following message:
Press PRINT for list
Test?
3.3.2. CALIBRATION
Calibration is required only for those tests where standards need to be read to determine
results.
The number of readings depends on test settings (number of standards, number of
repetitions). The device will require the standards in sequence, starting from the less STD1
concentrated one.
29
In the tests whose results are expressed in Ratio and INR, the device will require only one
reference plasma.
Note: Determinations cannot be done on two channels simultaneously during calibration;
however, we recommend doing determinations using the two channels alternately.
If no calibration is stored in the memory, the device will show:
Error
Curve not defined
Press Enter
3 7 C
N e x t
S T D 1
R E P 1
C H 1
s e c
C H 2
s e c
Apply the generic procedure to execute the standards as described in paragraph 3.3.3.
In this case, if you press reset1 the device will be prepared for clotting time determination for
the standard1 (S1) first replication (R1) in channel1 (CH1).
30
3 7 C
N e x t
S 1
S T D 1
R E P 1
C H 1
0 . 0
R 1
C H 2
s e c
s e c
After each reading, if you press enter the result will be stored and you can pass to read the
second replication of the standard. If the result obtained does not correspond to the expected
result, press reset to repeat the reading without storing the result. For each standard the
average of replications is printed and, at the end of determinations, the calibration curve is
printed.
In the event of a monotonic curve, the following will appear in the display:
Save curve [Y/N]
Error
Non-monotonic curve
Press ENTER
In the event of a non-monotonic curve, the following will appear in the display:
Error
Non-monotonic curve
Press ENTER
F i
i n g
c u r v e
1 :
U s e
o l d
2 :
R e c a l
3 :
M a n u a l
3 7 C
c u r v e
i b r a t e
c a l
i b .
2: Recalibrate
If there is a curve, the following is displayed:
Print for curve
Calibrate Y/N
3: Manual calib.
The following message will be displayed:
Edit time for standards
[y/N]
You can press Yes to correct the points of the calibration curve.
The device will present the times of the standards in sequence,
starting from the less STD1 concentrated one.
If you enter a monotonic curve, the following is displayed:
Save curve Y/N
Press Yes to execute the readings.
If you press No, you return to the Fitting Curve menu.
If you enter a non-monotonic curve, the following is displayed:
Non-monotonic error curve, press Enter.
If you press Enter, you return to the Fitting Curve menu.
Press No to return to the Fitting Curve menu.
32
3.3.3. DETERMINATIONS
The device allows for two simultaneous readings on the two reading channels (CH1 and
CH2). The device is provided with two timers preset based on test programming to check the
incubation time. At the end of the measurement the result, including the serial number and ID,
are displayed and printed, if requested.
The following is displayed in reading execution:
3 7 C
T i m e
C H 1
s e c
C H 2
s e c
to arrange the cuvettes with armature in thermostat setting to be heated in the positions
for reagent/plasma incubation.
Incubate the reagent/plasma for the preset time according to the type of test by activating
timer1 or timer2. When the times is active, a flashing T1 or T2 message is displayed.
When the incubation time is over, the T1 or T2 message stops flashing and a continuous
beep is emitted.
Introduce the cuvette to be tested into the selected reading channel and press reset1 and
reset2 to zero set the photometric channel. The display will show, for example:
P T
3 7 C
T i m e
C H 1
C H 2
0 . 0
s e c
s e c
33
Zero setting is marked by the value 0.0, which also indicates that the device is ready to
detect reagent/plasma dispensing (starter) to start the count.
When the reagent/plasma is dispensed into the test tube being read, the device
automatically starts the count of the clotting time and the agitator.
As soon as the clot is formed, the count and the agitator are automatically stopped, and
the results can be viewed and printed. In addition to the results, the serial reading number
is viewed on the left of the measurement channel (CH1).
If the device has been preset accordingly, the data are sent to the host computer, as
described in paragraph 1.5.
3.3.4. RESULTS
Readings can be expressed in different measurement units simultaneously. The device will
measure the coagulation time (sec.) and calculate the other parameters. Parameters are
calculated by calibrating the device against a standard or a reference plasma (Ratio, INR) or
more standards by means of a calibration curve (Act%, mg/dL, g/L, IU/L).
At the end of each reading, the result is displayed in the measurement unit selected, which
has been preset in the Edit test function (par. 3.4.1). The print will show the reading
expressed in all the measurement units programmed in the test.
Calculated parameters
The readings expressed in seconds depend on the reagent batch, the device and the
techniques used. The results obtained by different laboratories may differ considerably.
In order to reduce these differences, the result is best expressed in Ratio, by referring the
coagulation time of the sample to the coagulation time of a standard 100% plasma or normal
plasma, by using the following equation:
Ratio =
tempo campione
tempo plasma standard
The Ratio is calculated by using the standard or the reference plasma with 100% activity.
34
In order to make results independent from the type of reagent used, the result is expressed in
INR (International Normalized Ratio), by using the ISI (International Sensitivity Index) value,
with the following formula:
tempo campione
INR =
tempo plasma standard
ISI
3.4.
TEST PROGRAMMING
E d i
t e s t
2 :
C o p y
t e s t
3 :
D e l e t e
3 7 C
t e s t
35
Test
Test
Test
Test name
Test name
Test name
Test name
Incubation time
Incubation time
Incubation time
Incubation time
Units
Units
Units
Units
Units to display
(for more than 1
unit)
Units to display
(for more than 1 unit)
Units to display
(for more than 1 unit)
Units to display
(for more than 1 unit)
Sec.
Ratio
INR
Nr. of standards
STDn. conc.
Repeat standards
Edit time for standards Edit time for standards
STDn. Time
STDn. Time
ISI
Autoprint
Autoprint
Autoprint
Autoprint
Save method
Save method
Save method
Save method
36
Numeric from 1 to 99. If you enter the code of a test that has
already been entered, you can change test parameters. If you press
Print in this stage, you can obtain a print of the tests stored.
Test name
Print: next pg
1: sec
2: Ratio
3: INR
Units?
Valid data
Unit to display
37
1: Lin-Lin
2: Log-Log
Scale?
ISI
Digit the value of the International Sensitivity Index (ISI) used for
INR determination.
Autoprint [Y/n]
If you press Yes, you will set the automatic print of results at the
end of the reading.
Press yes to store the test in the memory and return to the
Programming menu. In the event of an already programmed test,
this question will be asked only if at least one change has been
made.
38
t e s t
S e l e c t
P r e s s
T e s t
t e s t
P R I N T
3 7 C
t o
f o r
c o p y
l
i s t
3 7 C
S e l e c t
P r e s s
T e s t
d e s t
i n a t
P R I N T
f o r
i o n
l
i s t
t e s t
3 7 C
P T
P r e s s
T e s t
P R I N T
f o r
i s t
39
3.5.
UTILITIES
From the main menu, press (3) to carry out the following operations: 1: Photometer Calib
and 2: Settings
3.5.1. PHOTOMETER CALIB.
If you select this function you can check the Volt amplitude of the photometric signal of the
two reading channels. This function is used by the Technical Support staff.
3.5.2. SETTINGS
This function offers the following options:
Ask ID [y/N]
Auto Counter?
To select paper feed speed for the print of the reaction curve or
platelet aggregation plot.
.
To obtain a print of the calibration curve.
Calib. Curve
Print [Y/n]
Reaction curve
Print [y/N]
40
Ask ID [y/N]
Baud rate
3.6.
41
ADP 20 M
ADP 40 M
+ 0285 L PRP
ADP 1 M
15 L (ADP 40 M)
+ 0285 L PRP
ADP 2 M
Adrenalin
Lyophilised preparations are available on the market for reconstituting in order to obtain
adrenalin solutions with a concentration of 500M. This 500M solution may be stored for
several weeks at 4C. In order to carry out the aggregation reactions with concentrations of
10 M of adrenalin proceed with the preparation of a work solution of 200 M (prospectuses
C and D).
(C) Preparation of a 200 M work solution of adrenalin
200 L (Adrenalin 500 M)
Adrenalin 200 M
42
+ 0285 L PRP
15 L (Adrenalin 200 M)
Adrenalin 10 M
Collagen
This is available as a suspension to be stored at 4C. Carefully mix the suspension before
use. In order to perform the aggregation test with a final concentration of collagen equal to 5
g/mL it is recommended preparing a work solution with a concentration equal to 100 g/mL
and following the instructions indicated in prospectus E.
(E) Performing of the test with a final collagen concentration of 5 M
15 L (Collagen 100 g/mL)
+ 0285 L PRP
Collagen 5 g/mL
1 :
T e s t
2 :
P r o g r a m m i
3 :
U t
4 :
A g g r e g a t
l i
e s e c u t
t i
i o n
n g
e s
i o n
r e c .
A g g r e g a t
r e c
. 3 7 C
C H 1
R e a d
P P P
C H 2
R e a d
P P P
Insert the cuvettes containing 285 L of PPP of the sample to be analysed into the
reading cells 1 and 2, press reset 1 and reset 2 for the transmittance calibration of 100%.
A g g r e g a t
i o n
i o n
r e c
. 3 7 C
C H 1
R e a d
P R P
C H 2
R e a d
P R P
Insert the cuvettes containing 285 L of PRP of the sample to be analysed into the
reading cells 1 and 2, press reset 1 and reset 2 for the transmittance calibration of 0%.
A g g r e g a t
i o n
r e c
. 3 7 C
C H 1
R e a g e n t
C H 2
R e a g e n t
Remove the cuvettes from the reading compartment, add 15 L of the aggregation work
solution to the 285 L of PRP and shake delicately by hand. Re-introduce the cuvettes
into the reading cells 1 and 2.
Press reset 1 and reset 2 to start recording the plots of the reading channels 1 and 2.
In the event of using one channel only, in order to use the other channel it will be necessary
to press enter at the end of the reading to return to the initial window.
44
Biphase when, after an initial aggregation wave, there is an arrest in the transmittance
variation following a complete aggregation represented by a secondary wave.
By analysing a platelet aggregation graph is it possible to gain information regarding both the
quantitative and qualitative nature indicated schematically as follows.
Information of a qualitative nature:
Shape change: this corresponds to a change in shape of the platelets which turn from
discoidal into spherical. This change, being connected to a reduction in the transmittance
percentage, is detected by the aggregometer and recorded as a brief plot under 0%.
Secondary wave: this detects the releasing of the platelet granules. The two waves,
primary and secondary, can be visualised on the curve, however with high concentrations
of inductor or in hyper-aggregating states, they may fuse and form one single irreversible
monophase wave.
Latency time: this indicates the time necessary at the beginning of the aggregation after
the addition of the inductor and is important for studying the aggregation of collagen.
45
Slope: this indicates the percentage of platelets that aggregate within the time unit. It
therefore expresses the aggregation or disaggregation speed.
Aggregate Quota % or Q.A %: this is the highest level of transmittance reached by the
aggregation curve; it constitutes one of the key points in the aggregative response and
represents the maximum quota percentage of aggregated platelets.
The aggregation speed is calculated from the tangent of the initial slope of the curve,
irrespective of whether mono or biphasic.
2 M ADP
Monophasic curve, irreversible.
The aggregation speed is calculated as in the case of the ADP 1M, that is, with the
tangent of the initial slope of the curve.
10 M Adrenalin
Biphasic curve with an initial low speed curve (expression of the affinity between
esogenous adrenalin and the receptor) immediately followed by the second curve relating
to the active response showing the higher speed. In therapies with aspirin or similar, and
due to the defect of the release phase of the granules, the second curve may be missing
altogether.
If the curve is biphasic, calculate the slope of the second curve which is usually higher
than the slope of the second curve.
46
5 g/mL Collagen
Monophasic curve preceded by the typical latency phase and simultaneously shape
change (increase in the transmittance).
The Q.A. and the aggregation speed are usually high seeing that this is an agent with a
high aggregating potential.
Aggregated quota and type of curve in relation to the aggregating agent and its concentration.
The reference interval is carried out with the Clot 2S instrument.
Aggregating instrument
(final concentration in the PRP)
Aggregated quota
Type of curve
ADP 1M
17%-57%
Reversible
ADP 2 M
38%-100%
Irreversible
Adrenalin 10 g/mL
62%-100%
Biphasic
Collagen 5g/mL
62%-100%
Irreversible
47
48
The Q.A.% seeing that it is the objective expression of the aggregating potential.
Any absence of the first curve and the delay in the appearance of the second curve (rare
events).
The slope has minor diagnostic weight due to being influenced in part by the platelet
concentration of the PRP, which differs from one sample to the next.
3.7.
TEST
3.7.1. MANAGEMENT OF SAMPLES
Take venous blood samples with extreme care. The blood shall not be contaminated by
any foreign matter, such as small flaps of fabric, as they might alter coagulation time.
Blood dilution with anticoagulants must be strictly exact and constant for all samples.
Gently mix the blood with the anticoagulation agent in a silicone glass tube or a
waterproof plastics tube.
Separate the plasma from the particle fraction as soon as possible, in any case not later
than 30 minutes after you have taken the sample.
If the test is not carried out immediately, the plasma can be stored at +4C for a few
hours.
49
PT
APTT
Fibrinogen
TT
Test
Test name
PT
APTT
FIB
TT
Incubation time
Units
Sec, Ratio,
INR, Act%
Sec
mg/dL
Sec
Units to display
Sec
Sec
Sec
Sec
Nr. of standards
Insert Standards
STD1 :12.5
STD2 : 25
STD3 : 50
STD4 : 100
STD1 : 62,5
STD2 : 125
STD3 : 250
STD4 : 500
Repeat standards
No
No
Hight Limit
Press Enter
Do not insert
Press Enter
Do not insert
50
Low Limit
Press Enter
Do not insert
Press Enter
Do not insert
Scale
Log-Log
Log-Log
ISI
1.35
Autoprint
Yes
Yes
Yes
Yes
Save method
Yes
Yes
Yes
Yes
In order to calculate the results expressed in Act%, a calibration curve must be built. To
this purpose, a pool of human plasma can be used (100% activity) collected from
healthy volunteers who are not taking any drug, or lyophilized control plasma, which
must be dissolved in distilled water, whose value is provided by the manufacturer in a
specific leaflet supplied with the package.
Starting with the human plasma pool or control plasma, prepare scalar dilutions with
saline solution to obtain standards with the programmed prothrombin activity
percentages (100%, 50%, 25%, 12.5%).
Execute 2 determinations for each standard following the calibration procedure (par.
3.3.2) and the procedure determination described below.
Use STD4 standard as a reference plasma for the calculation of the Ratio and INR.
If you do not want to build a calibration curve, you can refer to the table that comes with
each of thromboplastin batch and introduce the seconds corresponding to the preset
concentrations, as described in paragraph 3.4.1.
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Determinations
To start the test, transfer the cuvette into the measurement cell by gently stirring it and
press reset1 or reset2, depending on the channel you are using. When 0.0 is shown in
the display, you can start to take the measurement.
Add 100 L of plasma. The timer will start counting the coagulation time and
automatically stop when the reaction has taken place.
52
Note: We recommend that the measurements be taken in duplicate and that the
measurement of one control plasma be repeated for each working session.
Distribute 100 L of plasma and 100 L of APTT reagent pre-heated at 37C into the
measurement cuvettes provided with a thermostat; press timer1 or timer2 and leave in
incubation for the preset time (3 min.) based on the method adopted until you hear a
beep.
To start the test, transfer the cuvette into the measurement cell and press reset1 or
reset2, depending on the channel you are using. When 0.0 is shown in the display,
you can start to take the measurement.
Add 100 L of calcium chloride (CaCl2 0.025 M) pre-heated at 37C in the thermostat.
The timer will start counting the reaction time and automatically stop when the reaction
has taken place.
Note: We recommend that the measurements be taken in duplicate and that the
measurement of one control plasma be repeated for each working session.
53
Starting with the human plasma pool or control plasma, prepare scalar dilutions with the
imidazole solution provided with the kit at the programmed concentrations (500, 250,
125, 62.5 mg/dL).
Execute 2 determinations for each standard following the calibration procedure (par.
3.3.2) and the procedure determination described below.
If you do not want to build a calibration curve, you can refer to the table that comes with
each fibrinogen batch and introduce the seconds corresponding to the preset
concentrations, as described in paragraph 3.4.1.
Determinations
Distribute 200 L of the plasma being tested diluted according to the method described
into the measurement cuvettes provided with a thermostat; press timer1 or timer2 and
leave in incubation for the preset time (2 min.) based on the method adopted until you
hear a beep.
To start the test, transfer the cuvette into the measurement cell by gently stirring it and
press reset1 or reset2, depending on the channel you are using. When 0.0 is shown in
the display, you can start to take the measurement.
Add 100 L of fibrinogen reagent pre-heated at 37C: the timer will start to count the
reaction time and automatically stop when the reaction has taken place.
Note:
For fibrinogen concentrations lower than 100 mg/dL or greater than 500 mg/dL,
repeat the determination using different dilutions.
We recommend that the measurements be taken in duplicate and that the
measurement of one control plasma be repeated for each working session.
Distribute 200 L of the plasma being tested into the measurement cuvettes provided
with a thermostat; press timer1 or timer2 and leave in incubation for the time preset
based on the method adopted (2 min.) until you hear a beep.
To start the test, transfer the cuvette into the measurement cell by gently stirring it and
press reset1 or reset2, depending on the channel you are using. When 0.0 is shown in
the display, you can start to take the measurement.
Add 200 L of thrombin reagent. The timer will start counting the reaction time and
automatically stop when the reaction has taken place.
Note: We recommend that the measurements be taken in duplicate and that the
measurement of one control plasma be repeated for each working session.
56
4.
4.1.
MAINTENANCE
Scheduled servicing will help maintain the device in the best working conditions. We
recommend that the operations described below be regularly carried out:
4.1.1. EXTERNAL CLEANING OF THE INSTRUMENT
Clean the external surfaces of the instrument with a brush to remove the dust
WARNING:
Do not clean the instrument with compressed air or solvents that may
damage the paint.
57
58
59
4.2.
TYPES OF FAULTS
Should any anomaly occur, the instrument will suspend the execution of any operation and
one of the messages listed in the table below is displayed. Press Enter to cancel the
message displayed and recover operation.
Test Execution Errors
Message
Cause
Remedy
Undefined Test
The test required has not been previously Programme the test.
programmed.
Curve Not
Defined
Non-Monotonic The calibration curve is not monotone Check that the standards have
(always increasing or always decreasing). been read in the correct order
Curve
and repeat calibration.
Photometric Errors
Message
Cause
Remedy
Low Light
There is too little light for the photometric Repeat the measurement.
reading or insufficient volume in tube
Call Technical Assistance.
Too Much Light There is too much light for the photometric Repeat the measurement.
reading.
Call Technical Assistance.
The photometric reading is unstable
Bad Signal
No Stop Signal
Not valid
60
Hardware Errors
Message
RAM FAIL AT
$xxxx
Cause
Remedy
not
PROGRAM
CORRUPTED
NVRAM
Amnesia
NVRAM Failure
NVRAM Data
Mangled
The data container in the flash memory Cancel the memory and
are illegible.
programme the tests.
Filesystem
mangled
The A/D converter is not working correctly. Switch off and on again.
Call Technical Assistance.
Printer Trouble
and
61