Humaclot Junior

HumaClot Junior
| User Manual
|
Cat.No. 18680/1
Revision List of the Manual

No.
1
2
3
4
5
6
7
Rev. / Date
01/2004-11
02/2008-10
03/2009-02
04/2009-08
05/2009-12
06/2009-12
07/2010-09
REVISION DESCRIPTION
First edition
Adaptation to software version C5.20
Correction of typing errors, as well OD- and Coag Correction
Correction of typing error in description for Revision 2
D-Dimer added
Change of default values
Change of default values
ii
1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operators hand as well as at the
maintenance operators availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the GENERAL SAFETY
WARNINGS, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in
material or workmanship, provided that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no charge, except for transportation
expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in
the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly
maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
3 INTENDED USE OF THE INSTRUMENT [IVD]
The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
4 GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual.
Place the product so that it has proper ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
earth ground.
Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper
ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
5 DISPOSAL MANAGEMENT CONCEPT

The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
6 INSTRUMENT DISINFECTION
Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be
considered at least potentially infectious. Therefore every part and accessory of the respective instrument which
may have come into contact with such samples must equally be considered as potentially infectious.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authoritys interventions.
7 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
II
NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The BIOHAZARD warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authoritys interventions.
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: tech-support@human.de www.human.de
Contents
INTRODUCTION
1.1.1
PT (Prothrombin Time).
1.1.2
APTT (Activated Partial Prothrombin Time).
1.1.3
TT (Thrombin Time).
1.1.4
FIB (Fibrinogen).
1.1.5
DD (D-dimer).
1.1.6
General:
4
4
4
4
4
4
5
1.2 Theory of Operation
1.3 Turbidity Method (Clotting Method)
1.4 Immunoturbidimetric Method for D-dimer
INSTALLATION
2.1 Equipment
2.2 Overview
2.3 Technical Data
OPERATION INSTRUCTION
10
3.1 WARM-UP
10
3.2 TEST SELECTION
10
3.3 STOPWATCH
11
3.4 CALIBRATION
11
3.5 Default values of tests:
12
3.6 MEASUREMENT
12
PT DETERMINATION
13
4.1 SUMMARY
13
4.2 PRINCIPLE
13
4.3 INTERNATIONAL SENSITIVITY INDEX (ISI)
13
4.4 PREPARATION
13
4.5 PROCEDURE on HumaClot Junior
14
4.6 ASSAY CALIBRATION
14
4.7 QUALITY CONTROL
14
4.8 APPLICATION RECOMMENDATIONS
14
PTT DETERMINATION
15
5.1 SUMMARY
15
5.2 PRINCIPLE
15
5.3 REAGENT
15
5.4 PREPARATION
15
15
16
5.7 QUALITY CONTROL
16
16
FIB DETERMINATION
17
6.1 SUMMARY
17
6.2 PRINCIPLE
17
6.3 REAGENT
17
6.4 PREPARATION
17
17
6.6 PROCEDURE ON HumaClot Junior
18
6.7 QUALITY CONTROL
18
6.8 EXPECTED RESULTS OF CONTROLS:
18
18
TT DETERMINATION
19
7.1 SUMMARY
19
7.2 PRINCIPLE
19
7.3 REAGENT
19
7.4 PREPARATION
19
7.5 PROCEDURE ON HumaClot Junior
19
20
7.7 QUALITY CONTROL
20
20
DD DETERMINATION
21
8.1 SUMMARY
21
8.2 PRINCIPLE
21
8.3 REAGENT
21
8.4 PREPARATION
21
22
22
8.7 EXPECTED RESULTS
22
8.8 QUALITY CONTROL
22
22
SERVICE
23
9.1 Service Functions
23
9.2 Default values
24
9.3 Temperature Adjustment
24
9.4 Optic Adjustment
25
9.5 Optic Check
26
9.6 Interface RS 232
26
10
Troubleshooting Guide
27
11
REAGENTS, CONSUMABLES, SPARE PARTS, ACCESSORIES
28
11.1 CONSUMABLES
28
11.2 SPARE PARTS
28
ACCESSORIES
29
12
2/30
Notice
Every effort has been made to avoid errors in text and diagrams; however, HUMAN GmbH assumes no
responsibility for any errors that may appear in this publication.
It is the policy of Human GmbH to improve products as new techniques and components become available. Human
GmbH therefore reserves the right to change specifications if necessary in the course of such improvements.
Warning
Please read the user manual in its entirety prior to operating the HumaClot Junior. In order to ensure a high level
of performance, all warnings and references to technical safety in this user manual must be followed. Repairs to
the instrument may only be carried out by trained personnel, and replacement parts must comply with instrument
specifications.
The HumaClot Junior is intended for use with human plasma. As there is no known test that can offer complete
assurance that product derived from human blood will not transmit hepatitis, AIDS, or other infectious diseases,
appropriate precautions should be taken by the instrument operator. In case of plasma spilled on the instrument,
clean with a paper towel soaked in 10% bleach.
3/30 Human HumaClot Junior User Manual
1 INTRODUCTION
Hemostasis is the biochemical process that protects the body from loss of blood after vascular damage. Hemostasis
takes place in three phases:
Vessel contraction and platelet aggregation stop bleeding immediately (within seconds) and trigger the coagulation cascade.
The coagulation cascade is a chain reaction in which inactive enzymes are converted to their active form. The
cascade ends with fibrinogen to fibrin conversion, catalysed by activated thrombin. In the presence of activated
factor XIIIa the fibrin is cross-linked and clotted to an insoluble thrombus (fibrin-clot). The bleeding is finally
stopped.
To prevent thrombotic events in the body, coagulation has to be controlled very exactly. This is done by the
fibrinolytic system. Inhibitors are able to invert the activation of factors, thus regulating coagulation. The basic
inhibitors are antithrombin and protein C. The fibrinolytic system is also responsible for lysing the fibrin-clot. After
clot lysis the vessel injury is completely healed.
All factors and inhibitors are balanced very carefully. In the case of any imbalance or dysfunction, serious vascular
diseases can and do appear. Dysfunction of complex hemostasis is one of the most common vascular diseases, and
often results in death (~ 1 per 1,000 patients). Examples are deep-vein thrombosis (DVT) and pulmonary embolism
(PE).
The HumaClot Junior is a single-channel optical coagulometer for determining the basic parameters of the second
stage of hemostasis (coagulation cascade) in citrated human plasma. It is designed for in-vitro coagulation testing
in the clinical laboratory. Clotting assays with fibrin formation as the endpoint may be run on the instrument, as
well immunoturbidimetric tests such as quantitative D-dimer.
The following tests and features are available on the instrument:
1.1.1
PT (Prothrombin Time).
PT is expressed in seconds (100 ms sampling rate) and automatically normalised into INR (International
Normalised Ratio). A normal PT value (100%) and the Thromboplastin ISI - value (International Sensitivity
Index) can be stored on board. Additionally, the result can be converted into % activity, and a three-point
calibration curve can be stored in the memory.
1.1.2
APTT (Activated Partial Prothrombin Time).

APTT is expressed in seconds and automatically normalised into ratio. The normal APTT value can be stored
on board.
1.1.3
TT (Thrombin Time).
TT is expressed in seconds and is automatically normalised into ratio. The normal TT value can be stored on
board.
1.1.4
FIB (Fibrinogen).
FIB is expressed in seconds and is automatically converted into mg/dl concentration in plasma. A calibration
is necessary to obtain the results in mg/dl. Three calibration points can be stored on board.
1.1.5
DD (D-dimer).
DD is expressed in OD and is automatically converted into ng/dl D-dimer. A calibration is required to
obtain the results in ng/ml. Three calibration points can be stored on board.
4/30
1.1.6
General:
All tests are performed with half of the regular volumes. The micro-cuvette can be run with a minimum of
75 l. In some cases, however, it is recommended to use higher volumes to achieve high accuracy.
The HumaClot Junior supports a unidirectional RS232 interface (fixed setting at 2400, 8, 1, No). All results are
printed automatically if the interface is set to print mode. The RS 232 can also be set to debug mode. The raw
optical data are then sent to a PC terminal, where the clotting reaction is displayed.
The incubation area has positions for 8 samples and 2 reagents. The HumaClot Junior needs 3-5 minutes to warm
up to 37.0. A green signal light indicates the correct temperature has been reached.
1.2
Theory of Operation
The HumaClot Junior is a highly sensitive single-channel photometer. A very light-intensive LED optic at 400 nm
ensures accurate and precise results, even when icteric or lipemic samples are used. The receiver signal is detected
and converted to an electrical current. During the actual test the system seeks the best signal amplification;
therefore, it will support a wide range of different reagents (i.e. very turbid thromboplastin reagents or very clear
reagents). Additionally, the software is based on optical density (extinction), which absorbs outside light effects.
CUVETTE
PLASMA +
LASER
DETECTOR
Micro-Controller
PRINTER
DISPLAY
Figure 1: The detection principle

Plasma and reagent absorb the transmitted laser LED light. The rate of absorbance is obtained by the detector and
sent to the micro-controller. Here a program analyses the signal and sends the result to the display and printer
(optional).
1.3
Turbidity Method (Clotting Method)
The thrombin catalyzed conversion of fibrinogen to fibrin is the final reaction in the coagulation cascade. Fibrin
formation results in an increase in sample turbidity, which is detected by the photometer. Photometric detection is
started manually by pressing the Optic key while simultaneously adding the test reagent. The time between the
start of the photometric detection and the turning point of the reaction curve (see Figure 2) is the result. The result
is displayed in seconds on the liquid crystal display (and is sent automatically to the optional printer.)
EXTINCTION
0.120 E
END-POINT
OF REACTION
TURN-POINT
OF REACTION
13.0s
START OF TEST
(i.e. PT)
BEGIN OF
FIBRINOGENTRANSFORMATION
Figure 2: The turbidity method

The diagram is representative of a typical PT curve with normal control plasma. At ~10 sec the liquid plasma starts
to clot. This process ends at the end-point. The plasma is agglutinated by fibrin monomers.
1.4
Immunoturbidimetric Method for D-dimer
Intense light is able to penetrate turbid solutions, such as latex suspensions used for the determination of D-dimer
concentration. Latex particles, designed specifically for optical D-dimer testing, are coated with a monoclonal
antibody specific for D-dimer. If D-dimer antigen is present in the sample, an antigen-antibody reaction occurs,
with a simultaneous change in light transmission at 405 nm. The concentration of D-dimer in the sample is directly
proportional to the rate of the antigen-antibody reaction. The result is reported as the mean slope of optical
density per minute (mE/min, E = Extinction, a unit of light-absorbance). The following diagram illustrates the
measurement principle of the HumaClot Junior.
Figure 3: D-dimer cross-reaction

The D-dimer concentration is proportional to the rate of change in optical density. The HumaClot Junior calculates
the average slope of reaction, using the linear portion of the curve only.
The kinetic algorithm for D-dimer testing is illustrated by three typical reaction curves. At high doses the linear
relationship between signal and concentration is not valid. This is called High Dose Hook Effect.
6/30
High
ff
AB
S
O
R
BT
IO
N
O
F
LI
Dose
1000
/
3000
/
250
/
0
100 s
maximum
time [ s ]
Figure 4: Relationship of light absorbance and concentration of D-dimer.

The immunoturbidimetric algorithm:
Subsequent to latex addition, the instrument analyses the sample within 120 - 180 seconds.
measuring
100 mO D
S2
time for opti

mixing c ali
brat
ion
S1
signal
S0 = 0
Start=0
11s 20s
60s
120-180s
Figure 5: D-dimer determination with the kinetic absorbance principle. The result is expressed in mE and converted
through a calibration curve into ng/ml
Two signal points are to be taken, the first one at 60 sec and the second at 120-180 sec. The non-linearity of the
curve is calculated as S1 divided by S2. If the non-linearity is beyond a certain limit the result is reported as >5000
or XXX. This test should be repeated with a 1+3 diluted sample and the obtained concentration multiplied by 4.
2 INSTALLATION
No special precautions are necessary when starting up the HumaClot Junior. However, the following is
recommended:
-
Place on a level surface in an area free from excessive temperature fluctuations.

Avoid vibration during measurement.
Protect the instrument from direct sunlight, moisture and dust.
Check that the voltage and frequency data on the identification plate of the instrument correspond with
the local power rating before starting the instrument for the first time.
The instrument is connected to the power supply using the supplied mains cable. If obvious damage has occurred
during shipping, do not use. Contact your local distributor for replacement or repair.
2.1
Equipment
Standard delivery package

2.2
1
1
25
5
2
1
1
Pc
Pc
Pcs
Pcs
Pcs
Pc
Pc
HumaClot Junior
Power supply
Single cuvettes
Reagent tubes
Reagent adaptors
User manual
Warranty card
Overview
HumaClot Junior
On/Off
Optic start
Cursor up
Cursor down
Timer / Stopwatch
Enter
Test
Menu
Service / Malfunction
Ready to use
Optic channel
Figure 6: The front panel
8/30
2.3
Technical Data
Dimension:
Weight:
205 x 150 x 75 mm (WxDxH)

0.51 kg (without power supply)
Ambient Temperature:
18 - 23C
Power Supply
Input: 90-264 V~
Device:
Micro-controller Board
14 Bit ADC ; On-chip controlling of
LCD, RS232, keyboard, charging,
temperature, optic.
Interface:
Serial - 2400 baud, 8 bits, 1 stop, no parity

used in print or debug mode.
Optic Cell:
Photometer with pulsed 400 nm LED's

Variable pulse modulation.
Variable detector amplification.
Linear range 0.001 - 1.000 OD
Keyboard:
Foil keyboard with 8 keys and 2 LEDs
Display:
2 lines x 16 characters, liquid crystal
Incubation block:
1 measuring, 8 sample, 2 reagent wells; warmed to 37C.
Output: 12 V, 1.0 A
3 OPERATION INSTRUCTION
This section provides the general instructions necessary for the user to achieve maximal use and benefit from the
HumaClot Junior. For specific test applications refer to sections 4 - 8.
3.1
WARM-UP
The first visible screen gives the operator information on the installed software before changing to the warm-up
screen.
SOFTWARE C 5.20
Info Screen:
Software Revision
(here: Rev. C 5.20)
PT:
Red LED lights:

It takes approx. 5 minutes
for the instrument to
equilibrate at 37C.
000
PT:
active test
000
Green LED lights

The HumaClot Junior is
ready to operate.
stop watch
During the warm-up period no functions are available. The hidden service menu can, however, be activated during
the warm-up period. (refer to section SERVICE). The regular operator should not enter this menu.
3.2
TEST SELECTION
Eight different tests can be performed on the HumaClot Junior:

PT, PTT, TT, FIB, FAC, DD, AT3, PC.
PT:
TEST
000
PT:
Enter test selection with the

key Test.
Change active test with the

cursor keys.
Confirm active test with the

key Enter.
FIB:
000
To change tests, press key Test to activate test selection, cursor keys to change, and Enter key to confirm.
10/30
3.3
STOPWATCH
A stopwatch function helps the operator to control the correct incubation times.
PT:
123
stopwatch
To start the stopwatch press key Timer.

To stop and reset press key Timer again.
3.4
CALIBRATION
The specific parameters for the tests can be entered into the HumaClot Junior and stored.
Enter calibration with
PT:
000
key Menu.
PT:
PT:
PT:
PT:
Change parameter
with the cursor keys.
Confirm with Enter.
ISI
1.12
Change parameter (100% value = Normal value)

Confirm with Enter.
PT (100%)
12.0
Change parameter (50% value)

Confirm with Enter.
PT (50%)
16.7
Change parameter (25% value)

(0,0 s = no calculation to % activity)
Confirm with Enter.
PT (25%)
25.0
Active test is
calibrated.
PT:
000
Remark:
The input of values is done by pressing the up/down keys first in steps of 10, with the change of the direction in
steps of 1.
3.5
Default values of tests:

PT:
PTT:
TT:
FIB:
DD:
3.6
ISI = 1.10
(1) 100% (Normal)
Normal
Normal
(1) 300 mg/dl
(1) 3200 ng/ml
= 13.5 s
= 30.0 s
= 15.0 s
= 12.0 s
= 190 mE
(2) 50%
= 16.7 s
(3) 25%
= 26.1 s
(2) 150 mg/dl = 23.0 s (3) 75 mg/dl = 36.0 s

(2) 1600 ng/ml = 150 mE (3) 200 ng/ml = 30 mE
MEASUREMENT
Reconstitute the reagent according to the reagent description and pre-warm (if required) in the instruments
reagent positions. Insert the cuvettes into the incubation block (6 positions) and pipette the required volume of
plasma into the cuvettes. To start a measurement, place the specific cuvette in the Optic position.
PT:
PT:
PT:
WAIT !
ACTIVE
PT:
000
Activate the optic with the

key Optic.
000
This screen appears only for a few seconds

and switches automatically to next screen.
000
000
The measurement starts automatically with the addition

of reagent. In case of problems: press key Optic to start.
The measurement is running.

Dont touch the cuvette during a run!
The value in the second line show the optical density [OD].
0.023
If a clot is found, the result is displayed
and printed (if printer is connected).
PT:
12.8 s
000
I = 1.04 % = 00
Note:
Once started, a faint beeping sound is followed by a scrolling arrow. The current light absorbance (OD)
can be read on the display. Avoid contact with the cuvette while this message is shown. A beeping
sound will be heard again when a clot reaction is detected, and the result will be displayed. If a printer is
attached, the result will be also printed. If the clot reaction takes more than the maximum reading time
of 300 s, the optic will stop and display +++.+, which means no clot detected.
The measurement can be cancelled by pressing Optic again.
Autostart:
The measurement will start automatically when the reagent is added if the optic is set to active. For the some
tests (i.e. fibrinogen, thrombin) this feature does not work properly because the change in the signal is too
small. In this case, pipette quickly and vigorously, or simultaneously press optic when adding the reagent.
12/30
4 PT DETERMINATION
4.1
SUMMARY
The prothrombin time test, as originally devised by Quick, has been widely used for a number of years as a presurgical screen for assessing certain coagulation factors and in monitoring oral anticoagulant therapy. All stage II
and III factors are necessary for normal results when performing the prothrombin time test, so it is sensitive to
reduced levels or deficiencies in factors I, II, V, VII and X. Dicumerol and related drugs reduce the activity of the socalled "prothrombin complex," factors, II, VII, IX and X. Since the prothrombin time test is sensitive to deficiencies in
all of these factors, except IX, it has proven useful in monitoring oral anticoagulant therapy. The prothrombin time
test is also used in the quantitative determination (factor assays) of factors II, V, VII and X.
4.2
PRINCIPLE
Single-stage prothrombin time measures the clotting time of test plasma after the addition of the thromboplastin
reagent containing calcium chloride. The reagent supplies a source of "tissue thromboplastin," which activates
factor VII, and is therefore sensitive to all stage II and III factors. Deficiencies in stage I factors (VIII, IX, XI, and XII) are
not detected by the test.
4.3
INTERNATIONAL SENSITIVITY INDEX (ISI)
The International Committee for Standardization in Hematology and the International Committee on Thrombosis
and Hemostasis have agreed on recommendations for the reporting of prothrombin time results based upon an
International Sensitivity Index (ISI) for thromboplastin reagents and an International Normalised Ratio (INR).
Thromboplastin reagents are assigned an ISI value by calibrating them against an International Reference
Preparation, (IRP, 67/40) which by definition has an ISI = 1.0. The ISI value assigned to commercial thromboplastin
reagents, therefore, defines a comparative slope, or relative sensitivity, in comparison to the reference
thromboplastin. The lower the ISI value, the more "sensitive" is the reagent. By knowing the ISI of a particular
thromboplastin reagent, the ratio can be calculated which would have been found if the IRP 67/40 had been used
as the reagent.
This is termed the International Normalised Ratio (INR), and is determined by:
Patient PT (s)
INR = RISI = Ratio ISI = () ISI
Normal PT (s)
For HEMOSTAT THROMBOPLASTIN-SI an ISI value was assigned in relation to the WHO Standardised
Thromboplastin.
4.4
PREPARATION
A.
Anticoagulant. Use 3.2% buffered sodium citrate.
B.
Specimen Collection and Handling

1.
2.
3.
4.
C.
Obtain venous blood by clean venipuncture.

Immediately mix 9 parts blood with 1 part anticoagulant by inverting the tube against the stopper.
Centrifuge the specimen at 1,500 x g for 15 min.
Test the plasma sample within 2 hours; otherwise separate platelet-poor plasma from red cells using a
plastic pipette and store in a plastic vial or tube. Freeze immediately and thaw just prior to use.
Reagent Reconstitution
Reconstitute with high-purity water in the volume stated on the package insert. Agitate gently and let stand
undisturbed at room temperature for 15 minutes. After reconstitution, the reagent is stable for 7 days at 2...8C
and 24 hours at 15...37C.
D.
HumaClot Junior Preparation

1.
2.
3.
4.
5.
4.5
Turn on instrument and wait until the ready LED is lit.

Turn on printer, if connected.
Select "PT" as active test.
Check calibration.
Allow reagent to pre-warm at least for 5 minutes
PROCEDURE on HumaClot Junior
1.
Pipette 50 l plasma into cuvette.
2.
Pre-warm plasma for 3 minutes
3.
Transfer cuvette to measuring position.
4.
Activate optic (press key Optic).
5.
Add 100 l pre-warmed HEMOSTAT THROMBOPLASTIN-SI (measurement starts automatically).
6.
The instrument will read for a maximum of 300 s. If no clot is detected, the display will read +++.+ s.
7.
The result is displayed in seconds and INR.
4.6
ASSAY CALIBRATION
For INR calibration of PT, two parameters are required.
Normal value:
Determine the PT normal value with a plasma pool from healthy donors or use HEMOSTAT
CONTROL PLASMA NORMAL. The expected range is between 11 and 14 s.
ISI value:
Read the ISI value on the product labelling.
Enter both values into the HumaClot Junior.

4.7
QUALITY CONTROL
Control plasma, such as HEMOSTAT CONTROL PLASMA NORMAL and ABNORMAL, should be tested in conjunction
with patient samples. It is recommended that at least one normal and one abnormal control be run at least once
each shift and at minimum once per 20 patient samples. A control range should be established by the laboratory to
determine the allowable variation in the day-to-day performance of each control plasma.
4.8
APPLICATION RECOMMENDATIONS
1.
2.
3.
4.
5.
6.
7.
8.
Do not use glass. Use only plastic.

Do not delay the mixing of blood with anticoagulant.
Avoid extremely hemolytic or lipemic samples.
Avoid plasma contamination with tissue thromboplastin.
Avoid an improper ratio of anticoagulant to blood.
Run patient samples in duplicate. With differences greater than 5% repeat testing.
Run quality controls regularly to confirm reagent and instrument functionality.
Do not run a test if the green LED is off.
14/30
5 PTT DETERMINATION
5.1
SUMMARY
From its origins in the work of Langdell and co-workers, later modified by others, the Activated Partial
Thromboplastin Time test has been widely used for a number of years as a pre-surgical screen for assessing certain
coagulation factors and in monitoring heparin therapy. All factors of the intrinsic pathway are necessary for normal
results when performing the APTT test. It is used principally, however, to detect deficiencies in the stage I factors,
namely factors VIII, IX, XI and XII, as well as Fletcher factor. The APTT test is also used to monitor heparin therapy,
showing prolonged test results at approximately 0.1 units and above. The test is also used in the quantitative
determination (factor assays) of factors VIII, IX, XI, XII and Fletcher factor.
5.2
PRINCIPLE
The APTT test measures the clotting time of test plasma after the addition of APTT reagent, then allowing an
"activation time," followed by the addition of calcium chloride. Deficiencies of approximately 40% and lower of
factors VIII, IX, XI and XII will result in prolonged APTT. Heparin, in the presence of adequate amounts of AT-III will
also result in prolonged APTT.
5.3
REAGENT
HEMOSTAT aPTT-EL
Calcium chloride
5.4
PREPARATION
A.
B.

1.
2.
3.
4.
C.

Centrifuge the specimen at 1,500 x g for 15 minutes
Test plasma sample within 2 hours; otherwise separate platelet-poor plasma from the red cells using a
Reagent Preparation
Bring to room temperature prior to use. Mix well by swirling or inversion and keep a stirrer bar in reagent container
during use to avoid the particle activator from settling out. Avoid prolonged heating.
D.

1.
2.
3.
4.
Turn on the instrument and wait until the ready LED is lit.
Turn on the printer if connected
Select "PTT" as active test
Allow CaCl2 to pre-warm at least 5 minutes
5.5
ASSAY CALIBRATION
PTT results should be normalised against a normal value.
Enter the normal value into the HumaClot Junior. The PTT is then displayed in seconds and normalised into ratio.
5.6

1.
Pipette 50 l plasma into cuvette.
2.
Pre-warm plasma for 1-2 minutes
2. Add 50 l APTT reagent to plasma.

3. Incubate for 3-5 minutes (for consistent results, test all plasmas with the same time)
4. Transfer cuvette to measuring position.
5. Activate optic (press key Optic).
6. Add 50 l pre-warmed Calcium Chloride (the measurement starts automatically).
7. The instrument will read for a maximum of 300 s. If no clot is detected, the display will read +++.+ s.
8. The result is displayed in seconds and ratio.
5.7
QUALITY CONTROL
with the patient samples. It is recommended that at least one normal and one abnormal control be run at least
once each shift and at minimum once per 20 patient samples. A control range should be established by the
laboratory to determine the allowable variation in the day-to-day performance of each control plasma.
5.8
1.
2.
3.
4.
5.
6.
7.
8.

16/30
6 FIB DETERMINATION
6.1
SUMMARY
The enzyme, thrombin, is the penultimate protein in the clotting sequence, acting upon soluble fibrinogen and
converting it to insoluble fibrin. Normal plasma fibrinogen levels range from 200-400 mg/dl, although levels as
low as 10-20 mg/dl may occur in acquired or congenital hypofibrinogenemia. The determination of plasma
fibrinogen levels has proven to be a useful test in the diagnosis of hemorrhagic disorders relating to plasma
fibrinogen content. These include hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia and a
fibrinogenemia.
6.2
PRINCIPLE
The FIB reagent utilises the Clauss clotting time method for the determination of plasma fibrinogen levels, wherein
excess bovine thrombin is used to clot diluted plasma. First, a standard curve is prepared using a reference plasma
of known fibrinogen content (Fibrinogen reference plasma). When thrombin is added, the clotting time obtained is
inversely proportional to the fibrinogen content. Next, patient plasma, at a dilution of 1/10, is clotted with
thrombin and the resultant clotting time used to interpolate fibrinogen level from the standard curve.
6.3
REAGENT
HEMOSTAT FIBRINOGEN
6.4
PREPARATION
A.
B.

1.
2.
3.
4.
C.

Test plasma sample within 2 hours; otherwise separate platelet poor plasma from red cells using a
Reagent Reconstitution
Reconstitute with high-purity water in the volume stated in the package insert. Agitate gently until solution is
complete. The reconstituted material is stable for 8 hours at 15...25C, 7 days at 2...8C or may be stored frozen
within 4 hours for use within 30 days.
D.
Sample Preparation
Dilute sample 1:10 with buffer - included in HEMOSTAT FIBRINOGEN kit -.
(1 part sample to 9 parts buffer)
E.

1. Turn on instrument and wait until the ready LED is lit.
2. Turn on printer if connected.
3. Select "FIB" as active test.
4. Check calibration.
5. Do not pre-warm the HEMOSTAT FIBRINOGEN reagent
6.5
ASSAY CALIBRATION
For the calibration of fibrinogen five different dilutions of the calibrator (included in the HEMOSTAT FIBRINOGEN
kit) are required: the clotting time of fibrinogen reference plasma in the dilutions 1:5, 1:10, 1:15, 1:20, 1:40.
For the detailed procedure please refer to the package insert.
The clotting times and the fibrinogen concentrations have to be entered into the HumaClot Junior.
6.6
PROCEDURE ON HumaClot Junior

1.
Pipette 100 l plasma dilution (1:10 with buffer) into cuvette
2.
Pre-warm plasma for 4-6 minutes
3.
4.
5.
Add 50 l HEMOSTAT FIBRINOGEN reagent

(do not pre-warm reagent - the measurement starts automatically).
6.
The instrument will read for a maximum of 60 s.
7.
The result is displayed in seconds and mg/dl.
6.7
QUALITY CONTROL
with patient samples. It is recommended that at least one normal and one abnormal control be run at least once
each shift and at minimum once per 20 patient samples.
6.8
EXPECTED RESULTS OF CONTROLS:
Refer to the product labelling for the specific values of each control plasma.
6.9
1.
2.
3.
4.
5.
6.
7.
8.

18/30
7 TT DETERMINATION
7.1
SUMMARY
The enzyme thrombin is the penultimate protein in the clotting sequence, acting upon soluble fibrinogen and
converting it to insoluble fibrin. As a reagent, thrombin has proven useful in the laboratory evaluation of many
fibrinogen disorders, including hypofibrinogenemia and dysfibrinogenemia. A prolonged thrombin clotting time
will result in fibrinogen levels of about 100 mg/dl and below. Nonfunctional fibrinogen molecules
(dysfibrinogenemia) will also result in a prolonged thrombin time. Heparin, in the presence of adequate amounts
of AT-III, will also produce a prolonged thrombin time.
7.2
PRINCIPLE
The clotting time of test plasma is measured after the addition of TT reagent.
7.3
REAGENT
Bovine thrombin reagent
7.4
PREPARATION
A. Anticoagulant. Use 3.2% buffered sodium citrate.

B. Specimen Collection and Handling
1.
2.
3.
4.

Centrifuge the specimen at 1500 x g for 15 minutes
Test plasma sample within 2 hours when held at 22...24C or within 4 hours when stored at 4...8C;
otherwise remove platelet poor plasma from red cell using a plastic pipette and store in a plastic vial or
tube. Freeze immediately, and thaw just prior to use.
C. Reagent Reconstitution
Reconstitute with high purity water at the volume stated on the vial label. Agitate gently until solution is complete.
D.

1.
2.
3.
4.
7.5
Turn on instrument and wait until the ready LED lights.

Turn on printer if connected.
Select "TT" as active test.
Check calibration.
PROCEDURE ON HumaClot Junior
1.
Pipette 100 l plasma sample into cuvette.
2.
Pre-warm plasma for 3 minutes
3.
4.
5.
Add 50 l bovine thrombin (the measurement starts automatically).
6.
The instrument will read for a maximum of 300 s.
7.
The result is displayed in seconds and ratio.
7.6
ASSAY CALIBRATION
TT results should be normalised against a normal value.
Enter the normal value into the HumaClot Junior. The TT is then displayed in seconds and normalised into Ratio.
7.7
QUALITY CONTROL
with patient samples. It is recommended that at least one normal control be run at least once each shift and at
minimum once per 20 patient samples. A control range should be established by the laboratory to determine the
allowable variation in the day-to-day performance of each control plasma.
7.8
1.
2.
3.
4.
5.
6.
7.
8.

20/30
8 DD DETERMINATION
8.1
SUMMARY
A variety of pathological conditions, e.g. disseminated intravascular coagulation, deep vein thrombosis (DVT),
pulmonary embolism (PE) but also major surgery and other conditions may lead to excessive fibrin formation and
to intravascular thrombi. Subsequent fibrinolysis results in raising levels of D-dimer. D-dimer is a highly sensitive
but a non-specific marker. Therefore, D-dimer is suited to rule out a suspected DVT or PE but cannot be used to
confirm a thrombotic event.
8.2
PRINCIPLE
D-DIMER is a micro-particle enhanced immunoassay for the quantitative determination of D-dimer in citrated
human plasma using turbidimetric detection. When the reagent is exposed to a plasma sample, D-dimer will
agglutinate the particles, giving rise to an increased light-scattering. When exposed to the appropriate wavelength
of monochromatic light, the increase in measured turbidity, or light-scattering, is proportional to the amount of Ddimer in the sample.
First, a standard curve is prepared using a calibrator with known D-dimer concentration. Next, patient plasma is
tested and the obtained OD is used to interpolate D-dimer level from the calibration curve.
8.3
REAGENT
HEMOSTAT D-DIMER
8.4
PREPARATION
A.
B.

1.
2.
3.
4.
C.

Test plasma sample within 8 hours; otherwise separate plasma from red cells using a plastic pipette and
store in a plastic tube. Freeze immediately and thaw just prior to use.
Reagent Preparation, Storage and Stability
D-dimer latex reagent, reaction buffer and diluent are ready to use. Swirl the latex reagent gently to ensure
homogenous suspension. Reconstitute the calibrator with high-purity water as stated in the package insert.
Opened vials of latex reagent, reaction buffer and diluent are stable for 2 weeks at 825C or 4 weeks at 28C .
Reconstituted calibrator is stable for 12 hours at 4...25C. Avoid contamination of opened vials!
D.

1. Turn on instrument and wait until the ready LED is lit.
2. Turn on printer if connected.
3. Select "DD" as active test.
4. Check calibration.
8.5
ASSAY CALIBRATION
Re-calibrate every 3 months.

[CAL]
[DIL]
Concentration
(ng/ml)
Cal. 1
3,200*
200 l
0
Cal. 2
1,600*
200 l
200 l
Cal. 3
1
Measure Cal. 1 and Cal. 2 in duplicate; calculate mean
and enter data into instrument.
Cal. 3 is not measured, but the zero point is entered as
1 ng/ml enter 1 mE.
* Use the lot specific value to specify the exact concentration in each dilution
Verify the calibration curve with HEMOSTAT D-DIMER CONTROL HIGH/LOW

8.6
Pipet 25 l sample, calibrator or control into cuvette

Add 100 l reaction buffer
Pre-warm 2 10 minutes
Transfer cuvette to measuring position and activate optic
Add 50 l pre-warmed latex reagent
Mix well (15 x repeated pumping by using the pipette)
Result will be displayed OD and in ng/ml
8.7
EXPECTED RESULTS
The assay results are reported in ng/ml D-dimer. Samples with results exceeding the reportable range (>5000 or
XXX) have to be re-tested after 1+3 dilution with diluents (multiply result with 4).
The normal level of D-dimer is typically below 200 ng/ml. However, as there is no internationally established
standard for D-dimer, the concentrations may differ when using D-dimer assays from different manufacturers. It is
recommended that each laboratory establish its own expected range to reflect its patient population.
8.8
QUALITY CONTROL
HEMOSTAT D-DIMER CONTROL HIGH/LOW should be tested in conjunction with patient samples. It is
recommended that at least one normal and one abnormal control should be run once each shift.
8.9
1.
2.
3.
4.
5.
6.
7.
8.
Do not use glass pipettes and tubes. Use only plastic.

Highly lipemic samples should be diluted with diluent and re-tested.
Run patient samples in duplicate. With differences greater than 5% repeat testing
It is recommended to re-calibrate every 3 months or if the control plasmas are out of range.
HumaClot Junior needs protection from direct sunlight (very bright external UV light will interfere with
result)
9. Do not run a test if the green LED is off.
22/30
9 SERVICE
WARNING
Please read this section in its entirety prior to operating the HumaClot Junior. In order to ensure accurate and
reliable performance of the instrument, only authorised personnel, should perform any service functions on the
HumaClot Junior.
9.1
Service Functions
To enter the hidden service submenu, press key "Timer"
and Enter"
simultaneously.
WAIT FOR 37C

key "Timer" + "Enter"
PT:
LOAD DEFAULT ?
NO
000
The following service procedures can be performed on the HumaClot Junior:
Reset to default values

Temperature Adjustment
OD-Correction
Coag.-Correction
Optic Check
Set RS232
Use the cursor keys to change and key "Enter" to confirm!

Incorrect settings will influence the results significantly! Before changing anything, be aware of the consequences!
9.2
Default values
The HumaClot Junior can permanently store test and system parameters on board.
9.3
Calibration PT:
ISI
=
(1) 100% (Normal) =
(2) 50%
=
(3) 25%
=
1.10
13.5 s
16.7 s
26.1 s
Calibration PTT:
Normal
30.0 s
Calibration PT:
Normal
15.0 s
Calibration FIB:
(1) 300 mg/dl

(2) 150 mg/dl
(3) 75 mg/dl
=
=
=
12.0 s
23.0 s
36.0 s
Calibration FAC:
(1) 100 %
(2) 10 %
(3) 5 %
=
=
=
32.5 s
60.0 s
70.0 s
Calibration DD:
(1) 3200 ng/ml

(2) 1600 ng/ml
(3) 200 ng/ml
=
=
=
190 mOD
150 mOD
18 mOD
Temperature
OD Correction PT:
OD Correction PTT:
OD Correction TT:
OD Correction FIB:
OD Correction DD:
Coag Correction PT:
Coag Correction PTT:
Coag Correction TT:
Coag Correction FIB:
Coag Correction DD:
Optic check (mw):
Set Trigger (Autostart):
RS 232 Print Results
C
=
369 (9119)
100
100
100
160
180
100
100
95
100
120
approx. 11500 ( 1500)
250
(Data->RS232 = NO)
Temperature Adjustment
The incubation block of the HumaClot Junior maintains a temperature of 37C.

When the green LED is on, fill a reagent tube with 1 ml water and place it in a reagent position. Place a (digital)
thermometer in the reagent tube.
Allow to warm for 10 minutes and then read the temperature.
SET TEMPERATURE
C=371 (9085)
Example: The actual temperature is 37.1C and the digital target value is 9085.
Compare the temperature displayed by the system and the thermometer reading. If the temperature is different,
adjust the temperature on the HumaClot Junior by pressing the Up/Down cursor keys
Wait until a stable temperature of 37.0C is displayed on the HumaClot Junior. Check and correct the system
temperature if not equivalent to the external thermometer.
Up / Down keys for increase or decrease the temperature.
24/30
9.4
Optic Adjustment
A. OD CORRECTION
OD-CORRECTION
PT =
100
The measured optical density can be corrected by a factor for each test. Therefore, it is possible to adapt other
reagents.
(OD-CORRECTION = 100 optical density * 1.00 -> no effect)
(OD-CORRECTION = 120 optical density * 1.20)
OD-CORRECTION above 100 will cause:
-
reduce sensitivity of method
OD-CORRECTION below 100 will cause:

-
increase sensitivity of method
WARNING: OD-CORRECTION should be within 50 - 150

special: OD-CORRECTION for fibrinogen test
Run a 300 mg/dl calibrator. The result should be close to 10 s. If it is above/below 10 s, increase/decrease the ODCORRECTION slightly.
B. COAG CORRECTION
With the COAG CORRECTION the instrument can correct the result for better correlation to other systems or
reagents.
Example: On another instrument, a plasma sample is measured with PT = 12.1 seconds, on the HumaClot Junior
the result is 11.0 seconds. To get equal results, the results must be corrected by a factor of 1.10 (+10%).
This can be done by entering COAG CORRECTION = 110 (Factor 1.10).
COAG-CORRECTION
PT =
100
Negative COAG CORRECTION will cause:

-
shorter clotting times
Positive COAG CORRECTION will cause:

-
longer clotting times
CORRECTION for D-Dimer test

OD CORRECTION is used for sensitivity limit. (100 = 100mOD)
COAG CORRECTION is used to set the maximum reading time (100 = 120s)
9.5
Optic Check
The Optic check is recommended if problems with measurements arise. Remove any cuvette from the optic
position.
OPTIC CHECK
mw = 11323
014
The HumaClot Junior has adjusted this optic value (mw) to 11323 at an amplification (amp) level of 14.
Control range:
(ensure that no cuvette is placed in the optic position)
mw:
amp:
10000 13000
10-18
Press key menu to repeat the optic check, or key up/down to change the amplification.
9.6
Interface RS 232
The interface can be used in two ways:

Print Mode Results will be printed.
Debug Mode Reaction curve can be displayed on a PC.
DATA RS232
NO
(NO Print Mode; YES Debug Mode)
The interface port is set to 2400 Baud, 8 Bits, 1 Stop, No parity.
Example of a result printout:
01
PT:
12.5 s
I = 1.03
run #01
02
PT:
13.2 s
I = 1.35
run#02
03
PT:
12.8 s
I = 1.22
run#03
04
PT:
12.6 s
I = 1.04
run#04
26/30
10 Troubleshooting Guide
Note: Always verify instrument performance by testing appropriate control samples
System Error Message
Optic Failure!
Interpretation and corrective action

The HumaClot Junior is not operating within its optical specifications.
This can happen, if
There is not sufficient light (i.e. with extremely turbid reagents or
lipemic samples). Change to HUMAN reagent. Avoid extreme
samples.
External light is too intense (i.e. direct sunlight). Protect against
sunlight.
LED is burned out. Replace optic.
Measurement does not start The change in signal is too small.
automatically
This can happen with very clear reagents ( i.e. fibrinogen, thrombin).
Try to pipette quickly and vigorously or start measurement by pressing optic
key.
Measurement starts incorrectly Signal noise and temperature drift can start the measurement incorrectly.
Stop the measurement and activate the optic shortly before starting the
measurement.
Red Service LED is on
Electrical power is not sufficient.
Use original power supply.
Load battery pack, if used.
Green Ready LED is off
Temperature is out of range.
Wait a few minutes.
If error remains contact technical service
Temperature not correct
Adjust the temperature.
+++.+ s"No Clot Detect"
Always repeat the sample to verify result.
Possible reasons includes the following:
Clotting time is longer than 300 s.
Clotting time is shorter than 8 s.
Incorrect reagent used.
Fibrinogen level of sample is below 100 mg/dl ( i.e. sample dilutions ).
Air bubbles present.
Debris present in cuvette.
Sample improperly collected.
OD-Correction is set to zero.
Clotting time too short
Always repeat the sample to verify result
Optic is adjusted incorrectly.
Action:
- Use recommended materials
- Decrease OD-Correction slightly
- Increase OD-Range.
Clotting time too long
Always repeat the measurement to verify result.
Fibrinogen level is low.
Optic is incorrectly adjusted.
Action:
Use recommended materials.
Increase OD-Correction slightly.
Decrease OD-Range.
11 REAGENTS, CONSUMABLES, SPARE PARTS, ACCESSORIES

HEMOSTAT THROMBOPLASTIN-SI
Thromboplastin for the determination of Prothrombin Time (Quick test, PT)
Cat. No.
31002
31003
Format
Complete kit
Complete kit
Unit / Size
6 x 2 ml
6 x 10 ml
HEMOSTAT aPTT-EL
Activated Partial Thromboplastin Time
Cat. No.
33002
33012
33013
33022
Format
Complete kit
aPTT reagent
aPTT reagent
CaCl2
Unit / Size
2 x 6 x 4 ml
6 x 4 ml
6 x 10 ml
4 x 30 ml
HEMOSTAT FIBRINOGEN
Thrombin reagent for the determination of Fibrinogen
Cat. No.
33002
Format
Complete kit
Unit / Size
5 x 2 ml
HEMOSTAT THROMBIN TIME

Thrombin reagent for the manual and automated determination of the Thrombin Time
Cat. No.
34002
Format
Complete kit
Unit / Size
6 x 1 ml
HEMOSTAT CONTROL PLASMA

Normal and abnormal control plasmas with target values for PT, PTT, FIB, TT
Cat. No.
35001
35002
Format
CONTROL PLASMA NORMAL
CONTROL PLASMA ABNORMAL
Unit / Size
6 x 1 ml
6 x 1 ml
HEMOSTAT D-DIMER
Latex reagent, reaction buffer, sample diluent and calibrator for determination of D-dimer with HumaClot Junior
and HumaClot DuoPlus.
Cat. No.
36002
Format
Complete kit
Unit / Size
2 x 20 tests
HEMOSTAT D-DIMER CONTROL HIGH/LOW
Control plasma with high and low D-dimer concentration

Cat. No.
36012
11.1
Format
2 x high, 2 x low
Unit / Size
4 x 1 ml
CONSUMABLES
Cat. No.
Product
content
18690
19120
19130
19910/20
Single cuvette
Pipette 5 50 l
Pipette 20 200 l
Pipette tips yellow
500
1
1
10 x 1000
11.2
SPARE PARTS
Cat.No.
Product
content
18681/1
18681/2
18681/9
Power Supply 90-264VAC EU

Power Supply 90-264 VAC USA
Cable RS232
1
1
1
28/30
18680/1
User manual, English
Cat.No.
Product
Content
15615/20
15651/21
Thermo printer 230 VAV

Thermo printer 120 VAC
1
1
12 ACCESSORIES
30/30
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: human@human.de www.human.de

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Revision List of the Manual

4 GENERAL SAFETY WARNINGS

5 DISPOSAL MANAGEMENT CONCEPT

1.2 Theory of Operation

1.3 Turbidity Method (Clotting Method)

1.4 Immunoturbidimetric Method for D-dimer

2.3 Technical Data

3.2 TEST SELECTION

3.5 Default values of tests:

4.3 INTERNATIONAL SENSITIVITY INDEX (ISI)

4.5 PROCEDURE on HumaClot Junior

4.6 ASSAY CALIBRATION

4.7 QUALITY CONTROL

4.8 APPLICATION RECOMMENDATIONS

5.5 ASSAY CALIBRATION

5.6 PROCEDURE on HumaClot Junior

5.7 QUALITY CONTROL

5.8 APPLICATION RECOMMENDATIONS

6.5 ASSAY CALIBRATION

6.6 PROCEDURE ON HumaClot Junior

6.7 QUALITY CONTROL

6.8 EXPECTED RESULTS OF CONTROLS:

6.9 APPLICATION RECOMMENDATIONS

7.5 PROCEDURE ON HumaClot Junior

7.6 ASSAY CALIBRATION

7.7 QUALITY CONTROL

7.8 APPLICATION RECOMMENDATIONS

8.5 ASSAY CALIBRATION

8.6 PROCEDURE on HumaClot Junior

8.7 EXPECTED RESULTS

8.8 QUALITY CONTROL

8.9 APPLICATION RECOMMENDATIONS

9.1 Service Functions

9.2 Default values

9.3 Temperature Adjustment

9.4 Optic Adjustment

9.5 Optic Check

9.6 Interface RS 232

REAGENTS, CONSUMABLES, SPARE PARTS, ACCESSORIES

11.2 SPARE PARTS

3/30 Human HumaClot Junior User Manual

APTT (Activated Partial Prothrombin Time).

Figure 1: The detection principle

Turbidity Method (Clotting Method)

5/30 Human HumaClot Junior User Manual

Figure 2: The turbidity method

Immunoturbidimetric Method for D-dimer

Figure 3: D-dimer cross-reaction

Figure 4: Relationship of light absorbance and concentration of D-dimer.

time for opti

7/30 Human HumaClot Junior User Manual

Place on a level surface in an area free from excessive temperature fluctuations.

Standard delivery package

Figure 6: The front panel

205 x 150 x 75 mm (WxDxH)

Serial - 2400 baud, 8 bits, 1 stop, no parity

Photometer with pulsed 400 nm LED's

Foil keyboard with 8 keys and 2 LEDs

2 lines x 16 characters, liquid crystal

1 measuring, 8 sample, 2 reagent wells; warmed to 37C.

9/30 Human HumaClot Junior User Manual

Red LED lights:

Green LED lights