SERVICE MANUAL

Automatic Coagulation
Analyzer

update:
Jan Lukasz Stenzel
July 2015

“Bio-Ksel” Sp. z o.o.

ul. Kaliowa 3 86-300 GRUDZIĄDZ POLAND
telephone (0-56) 462-24-24, fax (0-56) 462-33-33, 46-54-518
www.bio-ksel.com.pl e-mail: [email protected]
Table of Contents

Pt. Table of Contents page

N ot ic e fro m M a nufa c t ur er 4
1. Pur po se o f t he A na lyz er 5
2. Tec hnic a l Pa r a m et er s 5
2.1 General characteristics of the analyzer 5
2.2 Technical parameters 5
2.3 Operating principle 6
2.4 Rated operating conditions 7
2.5 Reagents and consumables 7
3. M ea sur em ent Pr o gr a m s 7
4. Ser vic e o f t he Ana lyz er 8
4.1. Installation 8
4.1.1. Connecting the unit to power supply 8
4.1.2. Switching on the analyzer 9
4.2. Location and purpose of operating elements 11
4.2.1. Measurement and reagent block 11
4.2.2. Measuring cups tray 11
4.2.3. Plasma tray 11
4.2.4. Air filter 11
4.2.5. Rinsing liquid and wastewater containers 12
4.2.6. Container for used measuring cups 12
4.2.7. Rinsing opening 12
4.2.8. Block of dispensing pumps 12
4.2.9. Block of dispensing needles 12
4.2.10. Touch screen, keyboard, mouse 12
5. Oper a t ing t he A na lyz er 17
5.1. Preparatory activities 17
5.2. Switching on the analyzer 17
5.3. Privileges to operate the analyzer 18
5.3.1. User with the Administrator’s privileges 18
5.3.1.a Administrator’s logging in 18
5.3.1.b Change of access password 19
5.3.1.c Change of users 19
5.3.1.d Creating the List of Authorised Users 19
5.3.1.e Forgetting password by an ordinary user 20
5.3.1.f Administrator’s logging off 20
5.3.2. Authorised users – logging in and changing password 21
5.3.2.a User’s logging in 21
5.3.2.b Forgetting the password by user 21
5.3.2.c Changing the user’s password 21
5.3.2.d User’s logging off 21
5.4. Selecting mode of operation of the analyzer 22
5.4.1. Measurements 22
5.4.1.1. Entering patients’ data – List of Patients 23
5.4.1.1.a) Entering data manually 23
5.4.1.1.b) External barcode reader 24
5.4.1.1.c) Internal barcode reader 24
5.4.1.2. Placing reagents 25
5.4.1.3. Emergency tests 26
Quality control measurements - introduction of control
5.4.1.4. 28
plasmas

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5.4.2. Progamming 29
Creating a new program (example for the determination of
5.4.2.1. 30
fibrinogen by Clauss)
5.4.2.2. Measurement sets 33
5.4.2.3. Screen “Programming” - example for APPT 34
5.4.2.4. Screen “Programming” - example for AT III 35
5.4.2.5. Screens “Programming” - example for D-D 35
5.4.3. Calibration 37
5.4.4. Results 39
5.4.4.1. Searching for patients’ results 40
Searching for and graphic printing of quality control results.
5.4.4.2. 42
Levey-Jennings chart.
5.4.5. Technical program 42
5.4.5.1. Deaeration 43
5.4.5.2. Washing the needles 43
5.4.5.3. Measurements mode (available since version v3.10) 43
5.4.5.4. Transmission test 44
5.4.5.5. Entering the laboratory name 44
5.4.6. Finishing operations of the analyzer 44
6. Error Messages and Removing Malfunctions 44
6.1. General remarks 44
6.2. Malfunctions and their removal 44
7. Maintenance of the Analyzer 45
7.1. Periodic maintenance 46
7.1.1. Everyday maintenance 46
7.1.2. Weekly maintenance 46
7.1.3. Monthly maintenance 46
7.1.4. Half-year maintenance 46
7.1.5. Technical inspections 46
7.2. Other maintenance and repair activities 47
7.2.1. Replacement of hoses in peristaltic pumps 47
7.2.2. Replacement of air filters 47
Clogged needle or the so-called growth in the hoses of the hydraulic
7.2.3. 47
system
7.2.4. Preparing the analyzer for a long break 48
7.2.5. Starting up the analyzer after a long break 48
8. Procedure in Case of Voltage Interruption 48
9. Transmission of Results Analyzer - Computer 49
9.1. Setting transmission parameters 49
Decommissionig the Analyzer in order to Repair it or for
10. 50
Disposal.
10.1 Decommissioning the unit in order to make repair 50
10.2 Decommissioning the unit for disposal 50
11. Applied Symbols and Designations. 50
12. Demand for Consumables 50
13. Disposal of Used Consumables 51

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 NOTICE FROM MANUFACTURER
Due to possible damage to the analyzer during incorrect switching
off, Users are requested to definitely follow the below order of
activities (see also pt. 5.4.6 of Service Manual):

Switching off the analyzer.

 remove reagents from the reagent block and place

them in the refrigerator

 remove tested samples

 empty the container for used cups

 empty the wastewater container

 log off

 press the key ”Finish operations”

!!  Wait for approximately 15 seconds for closing the

systems shown as the blank screen

 turn off the analyzer using the switch on the back

panel

 cover the analyzer, especially the monitor if there are

UV lamps on in the room.

1. Purpose of the Analyzer

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The Coagulometer “bioksel 6000” is an automatic analyzer used for in vitro
diagnostics to perform the following tests:
 PT + Fibrinogen (time, PT ratio, INR, Quick, PT + Fibrinogen)
 APTT (Time, Ratio)
 TT (Time, Ratio)
 Fibrinogen Clauss Method (g/l)
 Coagulation Factors II, V, VII+X,
 Coagulation Factors VIII, IX, XII+XII
 AT III
 D-Dimer
 Protein C
 Plasmin Inhibitor (alpha-2 antiplasmin)
 Plasminogen and other

2. Technical Parameters.

2.1. General characteristics of the analyzer:

 tested material or reference  50 μl
 reagent  50 μl (100 μl)
 result reading – automatically from the calibration curve or calculated in relation
to the reference
 types of results: time, PT ratio, index QUICK, INR, RATIO,
fibrinogen concentration in g/l or mg/dl, % activity, U/l, U/ml,
D-Dimer – μg/l
 single, double or multiple measurement of the same material
 memory after disconnection from the power supply:
- date and time
- up to 15 000 results,
- 60 calibration curves,
- calibration values & standards for each program
 measurement time: 4 - 180 sec (subject to type of measurement)
Note!
No reaction is treated as time 120 sec (PT, TT) or 180 sec (APTT)

 automatic systems for turbidity compensation (possible measurement of lipemic,

hemolysed and hepatitis plasmas)
 self-compensation of the optical channel and cup contamination
 throughput: PT + fibr – 70 tests/per hour, APTT – 45 tests/per hour
 micromethod – single or double assays
 testing based on primary samples (no pouring)
 separate needles for dispensing tested material and reagents

2.2. Technical parameters:

2.2.1. Dimensions / weight: 70cm x 50cm x 40cm / 35 kg
2.2.2. Fuses: slow blow fuse (T) 2.0A
2.2.3. Type of electric insulation: basic insulation
2.2.4. Installation category (overvoltage category): II
2.2.5. Degree of contamination: 2
2.2.6. Control systems of the technical condition of the unit:
- initialisation of operations
- checking and aligning measurement channels
2.2.7. Memory after power supply disconnection:
- date and time, up to 15 000 results, 60 calibration curves
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 - calibration values and standards for each program
2.2.8. a) Thermostat / warm – up time: 37C  0,5C / 5  15 min
b) Cooled reagent block 8 - 15 C
2.2.9. Number of measurement channels: 8
2.2.10. Number of measurement paths: 3
2.2.11. Measurement ranges:
- 4 - 120 sec (PT, TT), 4 - 180 sec (APTT) for time measurement
Note!
No reaction is treated as time 120 sec (PT, TT) or 180 sec (APTT)
- 1 – 999 % for % activity
- 0.01 - 9 U/ml for international units
- 0.01 – 9 g/l for weight units
- 1 – 999 mg/dl for weight units
- 1 - 9999 µg/l for weight units
2.2.12. Resolution:
- 0.1 s for time measurement
- 1% for % activity
- 0.01 U/ml for international units
- 0.01 g/l for weight units
- 1 mg/dl for weight units
- 1 µg/l for weight units

2.2.13. Accuracy:
- 0.1 s for time measurement
- 1 % for % activity
- 0.01 U/ml for international units
- 0.01 g/l for weight units
- 1 mg/dl for weight units
- 1 µg/l for weight units
2.2.14. Repeatability: Cv up to 2.5% (for time measurement)
2.2.15. Other:
 length of the light wave: 405 nm
 colour touch display
 two-way communication in the laboratory computer network
 RS232 for connecting the unit to computer network
 USB sockets for connecting the barcode reader, printer
 Possible use of computer keyboard and mouse
 Maximum power consumption of approximately 150VA
 Internal nickel-metal hydride battery not to be replaced by the user

2.3. Operating principle:

Method of measuring the time of change of optical density in the course of clotting
reaction and simultaneous analysis of the reaction kinetics has been used for
chronometric measurements tests (PT, APTT, TT, Fibrinogen, Coagulation Factors).
Program of the unit controls the course of the reaction starting from adding the
initial reagent up to the end of the course of the coagulation reaction. The basic
result (time) can be recalculated into final results as programmed by the user.
Measurement time has been limited up to 120sec for PT and TT, and 180sec for
APTT.
Measurement of the colorimetric reaction kinetics has been applied for
measurements using chromogenic substrates with a limited measurement time.
Following determination of the rate of absorbance changes for a material sample,
the rate is then calculated according to the rate of absorbance changes for the
reference sample and the final result is produced.

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2.4. Rated operating conditions:

- ambient temperature +15°C ÷ +32°C

- relative humidity 5 ÷ 85%
- atmospheric pressure 73 ÷106 kPa
- vibrations, water, salt, sand and
dust content in the air: negligibly low
- unit placement horizontal + 5%
- power supply 230V/50-60Hz/100VA

2.5. Reagents and consumables.

The system of reagents and consumables is a closed system.
Only the Bio-Ksel System or Bio-Ksel EKO reagents, “Chrom” cups must be used as
well as consumables recommended by the manufacturer of the analyzer.
Other reagents and consumables applied by the user will result in material damage
to the analyzer and loss of guarantee and warranty.
No test tubes for blood collection can be used without the prior approval by the
manufacturer of the analyzer.
In case of changing the type or model of test tubes, the manufacturer must be
absolutely consulted.

3. Measurement Programs.
The analyzer “bioksel 6000” has user-definable measurement programs
ordered in accordance with measurements methods included in the analyzer
program.
Each program may be designated with any name and number. This enables the
user to, e.g., remember calibration values and measurement parameters for
reagents from different lots, or to modify the same program in terms of types of
obtained and printouts.

Table 1.

List of basic measurement methods.

No. Method name Type of results

1 PT Time, PT Ratio, Quick index, INR
2 APTT Time, Ratio
3 Fibrinogen g/l, mg/dl
4 TT Time, Ratio
5 Coagulation factors group I % activity
6 Coagulation factors group II % activity
7 AT III % activity
8 D-Dimer μg/l
9 Protein C % activity
10 Plasmin Inhibitor (α2-Antiplasmin) % activity
11 Plasminogen % activity

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4. Service of the Analyzer.

4.1. Installation.

The analyzer is designed to operate in closed and heated rooms under the following
ambient conditions:

- place not exposed to direct sunlight, protected from UV rays and away from
direct heat sources
- ambient temperature
- relative humidity
- atmospheric pressure
- vibrations, water, salt, sand and
dust content in the air:
- placement of the unit
- power supply

4.1.1. Connecting the unit to power supply.

+15°C ÷ +32°C
5 to 85%
73 ÷106 kPa

negligibly low
horizontal + 5%
230V/50-60Hz/100VA

The manufacturer’s service engineer connects the unit to the power

supply when mounting the analyzer for the first time. The connection
must not be changed when operating the analyzer otherwise the
guarantee will be void.
In particular, the display, analyzer and printer must not be connected to
different sockets (other than to the power strip), as there is a risk of
damage to the analyzer due to power supply from different phases of
the power supply.

Figure 1. Connection of the unit along with the UPS emergency power supply

ATTENTION:
For safety reasons the emergency power supply (UPS) may be connected
only to the socket outlet with earthing contact!
.

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NOTES:
1. Switch of the UPS emergency power supply should be permanently in the
“ON” position
2. Printer must not be connected to the UPS emergency power supply
3. Do not place any reagents or any other objects on the analyzer.

4.1.2. Switching on the analyzer.

Check if the unit is connected according to Figure 1.

Check if the power supply plugs of the analyzer, display and printer are
securely and fully inserted into their sockets in the equipment.
If the analyzer operates with the external barcode reader, printer, keyboard
and mouse, they must be connected to proper sockets on the monitor
housing (Figure 2 and Figure 3).
Turn on the analyzer using the switch on the back panel (Figure 5)
Turn on the monitor using ON / OFF button (Figure 2)

ON / OFF

LAN network analyzer USB power

„bioksel 60000” socket

Figure 2. The slot on the back side of the monitor

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 USB socket

Figure 3. The slot on the right-hand side of the monitor

Figure 4. The slot on the right-hand side of the analyser housing

 power switch

 fuse

 power cable socket

Figure 5. Analyzer “bioksel 6000” view of the back panel

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4.2. Location and purpose of operating elements.

Figure 7. Analyzer “bioksel 6000” front view

4.2.1. Measurement and reagent block.

The measurement block thermostated at 37 oC is designed for incubation of

reagents and tested material as well as for making measurements. Directly by the
measurement block there is the cooled (8 - 15 °C) reagent block.
4.2.2. Measuring cups tray.

On the left-hand side of the analyzer there is a rotating (store) tray with 90 empty
measuring cups. Before starting operations, the tray must be filled up with cups.

4.2.3. Plasma tray (patients, control and calibration plasmas).

On the right-hand side of the analyzer there is a rotating tray designed for filling
with patients’ sample test tubes (20 ordinary opening + 3 openings for emergency
tests), vials with control and calibration samples (5 openings) and diluents (A, B - 2
openings). The analyzer housing has special pockets for placing caps with plugs of
reagents, samples and diluents.

4.2.4. Air filter.

Air filter (with exchangeable insert) is located in the analyzer floor in the middle -
under the front panel (next to the container for used cups).

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4.2.5. Rinsing liquid and wastewater containers.

Containers are located behind the analyzer. The rinsing liquid container should be
placed in a special grip on the analyzer back panel. The wastewater container is to
be placed below the surface where the analyzer is located, preferably on the floor of
the room. Both containers are equipped with plugs and attached hoses and liquid
level sensors.

4.2.6. Container for used measuring cups.

Container for used measuring cups is located in the left-hand front side of the
analyzer and is provided with a disposable insert. The opening for used cups is
placed between the measurement block and the cups tray. Before starting
operations, used cups must be removed from the container.

4.2.7. Rinsing opening.

Rinsing opening is located between the measurement block and patients’ tray and
is designed for rinsing dispensing needles.

4.2.8. Block of dispensing pumps.

Block is located in the upper part of the housing and is accessible in order to check
the pumps, to replace hoses and for maintenance.

4.2.9. Block of dispensing needles.

Block contains the needle dispensing the tested sample, the heated reagent needle
and the holder to carry measuring cups. The block is located on a mobile carriage.
When the analyzer is switched off, the carriage may be gently moved for
maintenance – in order to blow through the measurement openings.

4.2.10. Touch screen, keyboard, mouse.

The analyzer is equipped with a colour touch screen. Touching an icon on the
display corresponds to pressing the key. In appropriate time of operation there will
also appear necessary virtual keyboard on the display. A softly rounded stylus is
recommended for virtual keys.
The touch screen may be used along with the typical external computer keyboard
and a mouse. The computer keyboard and the mouse should be connected to
proper sockets on the monitor housing. Connecting must be made before the
analyzer is switched on (pt 4.1.2).

Figure 8. Virtual keyboard.

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Figure 9. Virtual keyboard – to switch to capital letters use the “Caps” key

Figure 10. Virtual keyboard – to change characters use the “Shift” key.

 deleting a character on the left of the cursor

 deleting a character on the right of the cursor

 ENTER key

Figure 11. Virtual numeric keyboard.

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Fig. 12. Check List Screen (Check List).

Perform all the actions specified in the list and confirm it with the button "Analyzer
is ready to work" or use the button "Skip" to move on to the next screen

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Figure 13. Main screen.

 Blinking sensor icon means that the analyzer is not ready for operations.
 Fast and double clicking the “STOP” key or opening the cover will result in
emergency and immediate halt of the analyzer operations.
 Colour of the position on the screen means the following:

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Position colour Position status
Grey
Position empty or inactive

Green
Position full or active

Yellow
Measurement in the position has been completed

Red
Measurement in the position has not been completed

 colours of message screens mean as follows (examples):

Green: end of the process

Yellow: the process in progress

Red: the process cannot be performed due

to ..................

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5. Operating the Analyzer.

5.1. Preparatory activities:

Before the analyzer is connected to the power supply:

 check and replenish the rinsing liquid,

 empty the wastewater container
 empty the container for used cups
 put new cups to the container
 close the cover

5.2. Switching on the analyzer:

 switch on the analyzer with the switch on the back wall and the button SWITCH
ON / SWITCH OFF on the monitor case (Fig.2)
- a login screen appears
 log in (see pt. 5.3. “Privileges to operate the analyzer”)
 button "Next"
- the Start Screen appears (Check List)
 Perform all the actions specified in the list and confirm with the button
"Analyzer is ready to work" or use the button "Skip" to move on to the next
screen
- the Main Screen appears
 perform or check if all the actions specified in the window "Start
of the Day" and push the key "New warehouse of samples"
 close the cover
 check the condition of each probe from the lower row in the Main Screen.

A flashing symbol of a probe means the lack of operating readiness. The cause
must be removed or one should wait for a few minutes for the measuring and
cooling units to reach the appropriate temperature.

Attention!
If any sensor blinks indicating the lack of operating readiness:
a) The analyzer cannot be started for measurements using the button
“Start”.
b) Other activities can be performed:
- reading the results
- entering patients’ data
- programming the analyzer

 it is recommended to deaerate the system and cleaning needles (pt.5.4.5.)

 press “Start”

- the analyzer performs preparatory activities for operations (initialization).

If initialization has been correctly performed, in the message window there
appears a message “Initialization finished. Tests can be performed”

 start the analyzer operations.

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5.3. Privileges to operate the analyzer.
Protection of patients’ personal data stored in the analyzer memory makes it
necessary for the individual operating the analyzer (hereinafter referred to as the
user) to log in by entering his/her individual password. Current operations on the
analyzer may be performed by only one actually logged in user. It is not possible
for a few users to log in simultaneously (thus, working at the same time).
Trained medical personnel with required technical qualifications are authorised to
operate the analyzer and work on it. It is required that the first startup of the
analyzer along with training, calibration of the unit, control measurements and
patients’ plasma measurements be performed by the authorised manufacturer’s
service.

5.3.1. User with the Administrator’s privileges.

The Administrator (e.g., head of the laboratory) based on his/her qualifications and
privileges connected with his/her position prepares and approves the List of
Authorised Users to work on and operate the analyzer. Only individuals entered in
the List may start the analyzer (after logging in).
a) Administrator’s logging in:
 switch on the analyzer – login screen opens
 select “Administrator” from the list on the screen
Note: Name “Administrator” cannot be removed and cannot be changed

 enter the password of minimum 4 and maximum 12 letters or digits or mixed

characters (virtual keyboard will be displayed after placing the cursor in the
white box “Password”)
 Log in

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If the Administrator’s password is forgotten, deleting old password and
entering a new password may be performed only after contacting the
manufacturer’s service.
b) Change of access password
In order to change the access password of a logged in user (including the
Administrator), use the tab ”Account setting”. Proceed according to description and
messages.
c) Change of users
In order to change users, use the tab ”Users”
The tab is displayed only to the Administrator (or the user with administrative
privileges) and it allows to:
- add a new user to the list of users
- remove the user
- delete the forgotten password of an ordinary user or user with administrative
privileges (see pt. 5.3.1.e)
- grant or change user’s privileges (also Administrator’s privileges), including
granting Administrator’s privileges to any user from the list.

d) Creating the List of Authorised Users:

 after the Administrator logs in, click the tab ”Users”

 open the tab ”Add User”

 enter the name of new user and twice the access password required for logging
in

Note: name of the entered user (e.g., first name and surname) will appear
on the printout of results as the person doing the test.

 key ”Add User”- there will be displayed the new user’s privileges screen

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 determine the scope of user’s privileges by ticking appropriately:

- authorised; - not authorised

e) Forgetting password by an ordinary user

Password forgotten by an ordinary user may be changed only with the participation
of the Administrator or individuals who have the Administrator’s privileges.
The Administrator – after logging in will proceed in the following way:
 from the level of Main Screen:
 button “Operator: Administrator” – login screen is displayed
 tab „Users”
 tab „Delete password”
 “Yes”
Only the forgotten password is deleted; however, privileges to date of the forgetful
user (on the screen “User’s privileges”) will not be deleted or changed.
Within 5 minutes from the Administrator’s logging off the forgetful user has the
time to enter a new password:
 “OK”
 tab “Logging”
 “Log off” (the Administrator’s logs off)
 Open the list of users and select the forgetful user
 Leave the box “Password” empty
 “Log in”
 “Change password”  „OK”
 enter new password
 “Change password”
Password has been changed.
If within 5 minutes from the Administrator’s logging off the forgetful user has not
entered a new password, entry of a new password will be blocked. Steps in pt. c)
have to be repeated.
f) Administrator’s logging off
The Administrator’s logging off is intended to switch off the analyzer (to finish
operations) or to change the user:
 to finish work on the currently used screen (the screen depends on the
operation performed by the Administrator) and return to the Main Screen
 button “Logged in Administrator” – login screen is displayed
 “Log off”
 “Finish operations” – the analyzer program switches off or
 “Log in” – new user’s logging in

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5.3.2. Authorised users – logging in and changing password
Current work on the analyzer may be performed by only one user logged in at this
time. Thus, logging in by a few users is not possible (hence, parallel work by other
users).
Only persons present on the List created by the user with the Administrator’s
privileges can start and operate the analyzer (pt. 5.1.1).
a) User’s logging in
 switch on the analyzer – login screen opens
 select the user from the list
 enter password
 “Log in” - proceeding to normal operations of the analyzer
b) Forgetting the password by an ordinary user: see pt. 5.1.1.c.
c) Changing the user’s password
Changing the password does not require the Administrator’s participation:
 switch on the analyzer – login screen opens
 select the user from the list
 enter the password
 “Log in” - Main Screen opens
 button “Logged in xxxx”– login screen appears
 tab “Account settings”
 enter current – old password
 enter new password
 repeat new password
 “Change password” - password is changed
 “Continue”– proceeding to normal operations of the analyzer
d) User’s logging off
Logging off the current user is designed to switch off the analyzer (to finish
operations) or to change the user:
 finish the operation on the currently used screen (screen depends on the
operation performed by the user) and return to Main Screen
 button “Logged in xxxx” – login screen appears
 “Log off”
 “Finish operations”– the analyzer program is switched off
or
 “Log in” – logging in new user

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5.4. Selecting mode of operation of the analyzer.
Mode of operation of the analyzer is selected in the main menu.
Specific modes separate and order operating activities of the analyzer:

“RESULTS” - reviewing, printing or sending to the computer network patients’

results and quality control results stored in memory.

“MEASUREMENTS” - assaying samples or control material.

“PROGRAMMING” - adjustment of measurement parameters to various reagent

applications, selection of methods, selection of number of measurements: single of
double, selection of result types, entering Cv coefficient, entering reference range
and possible repetition of measurements beyond the reference range.

“CALIBRATION” - self-calibration, entering or editing (reading):

- reference values (calibration values),
- calibration curves,
- indexes (ISI, ß and other).

“TECHNICAL PROGRAM” - technical control of the analyzer

(program for authorised service)

5.4.1. MEASUREMENTS.

Selection “MEASUREMENTS” is designed for assays of samples or control material.

NOTES:

1. Basic condition for correct assay results is maintaining exactly the same
conditions for the performance of assays and calibration..
Thus, the same method should be used, reagents of the same lot and prepared in
the same way as well as the same way of setting measurement parameters as for
the analyzer calibration.
2. Perform control assays before each series of measurements (pt. 5.4.1.4.)
3. Perform calibration (pt. 5.4.3.) after the change of reagent lot or when the
results of control assays are not correct.

 Perform preparatory activities and switch on the analyzer according to pts. 5.1.
and 5.2.
 Prepare reagents in accordance with the manufacturer’s recommendations
 Check if the lot or type of reagents have not been changed (if yes, perform
calibration of the analyzer – see chapter “Calibration” pt. 5.4.3.)
 Collect the blood into sodium citrate 3.2% in the proportion 1:10 (1 unit of
anticoagulant + 9 units of blood) and stir slowly in order to avoid haemolysis.
After checking that the blood does not contain clots, it should be centrifugated
for 15 minutes at 1500 x g. Plasma should be centrifugated within 30 minutes
since blood collection and kept in the refrigerator (no longer than for 3 hours).

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5.4.1.1. Entering patients’ data – List of Patients.
5.4.1.1.a) Entering data manually:
 switch on the Main Screen
 click on the position with the patient’s number on the plasma tray
- window “Patients” is displayed with blinking position selected

 it is compulsory to enter patient’s number (entry of other data according to

laboratory standards – or further entries may be omitted)
 place the test tube with the plasma of the described patient to the indicated
position in the plasma tray
 click the orange field “Tests” - list of available tests is displayed
 select the test – selected tests will be displayed in white fields
 “OK” in the green field
 proceed to the next patient by clicking the circle with the patient’s number or
left-right arrows
 having finished entering the data, the whole List of Patients may be displayed by
clicking “Measurements” on the Main Screen
Notes:
1. Minimum entry for each patient is the number and type of test.
2. It is also possible to enter patient’s numbers and data, and at the end of the
list (by the last patient) select necessary tests and click the key “All” (this
only applies to the operating mode when the analyzer is not
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 connected to the computer network).
Tests selected in this way will be performed for all patients on the list.
3. At this stage, at any moment it is possible to return to any plasma and verify
entered data and type of tests.
5.4.1.1.b) External barcode reader:
 Select patient’s position – it should change to green
 Activate the field “Patient’s number” – active field is green
 Read the barcode from the test tube – necessary data should fill in proper fields
on the screen within the scope they have been coded when collecting samples
 Immediately and unmistakenly place the test tube in the selected measurement
position

5.4.1.1.c) Internal barcode reader:

 Place successive test tubes (described with the code) in the drum openings so
that the code is on the outer side of the drum and can be read by the internal
reader
 On the Main Screen press “Measurements” – window of the List of Patients is
shown, which, after scanning, will display necessary data within the scope they
have been coded when collecting samples.

Note:
Scanning any position may be omitted by removing “√” by touching the line on the
List of Patients (on the example screen only circles 1-10 are intended for scanning).
Re-touching the line restores the selection.

 Press the button “Skanuj” /scan/. Then rotation of the drum and code reading
take place. Data on the List of Patients show if the reading has been correct. If
the code has not been read correctly, the given line remains empty. The
position of the test tube must be corrected so that the code is readable by the
internal reader and perform the code reading again.

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After having finished scanning the List of Patients – “OK”
- Main Screen is displayed with green positions of the patients’ tray (from the List
of Patients) and block positions for placing reagents.

5.4.1.2. Placing reagents.

 click the reagent block
- screen “Reagent Rack” is displayed

 place reagents according to the description

 click the pointer anywhere on the screen, "Block Rack" - appears in main
screen

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 close the cover
 key “Start” - successive measurements start based on the predetermined list
of plasmas
 after completion of measurements, a working list with current results is
displayed and possible fast printing (key: „Print results”):

 make another working list, load patients’ plasma and start measurements

5.4.1.3. Emergency tests

The analyzer program enables loading up to 3 emergency tests at the same time.
If the emergency plasmas are loaded along with the plasmas from the working list,
the analyzer performs them as the first ones.

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Emergency tests in the course of performing tests from the list of patients:
 press the key “CITO”
- the analyzer finishes measurements already started
 wait for the display of “Cito”
 click a position in the yellow field of cito

Note:
Green fields on the patients’ tray mean unfinished tests from the List of Patients.
The analyzer will start the tests after having completed emergency tests.

 enter the necessary data and types of tests likewise for the list of patients
 “OK”

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 open the cover
 place emergency plasmas
 replenish reagents (if needed)
 “Start” – consecutive measurements from the pre-defined list of emergency
tests begin
After completion of measurements, a working list is displayed with emergency test
results and possible fast printing (key: “Print results”)

5.4.1.4. Quality control measurements

- introduction of control plasmas.
Control assays must be performed prior to the beginning of assay series and
always in the case of doubts as to the quality of results.
In order to perform control assays:
 on the Main Screen click the control plasma position (one in five in the blue
field)
- screen ”Control plasmas” is displayed with blinking position which has been
selected

 Select control plasma from the list (or enter parameters of new plasma by filling
in appropriately the screen fields with data from the control plasma brochure)
Note!
1. Only users authorised to change calibration and analyzer programming (see
pt. 5.3.1.d) may introduce permanently new control plasma which will be
saved in the list of plasmas after pressing “Save”. Other users may program
parameters of new control plasma and perform control assays on it; however,
the plasma will not be permanently saved in the list of control plasmas
2. Pull down list of control plasmas may contain a maximum of 15 items. After
entering successive new control plasmas, the oldest items will be
automatically removed from the list.

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 Select number of test repetitions (from 1- no repetitions, up to 24 repetitions)
 From the list “Tests” select the type of control test. Selected tests are displayed
in the white field
 Press “OK” in the green field of the list of tests – screen with selected control
plasma is displayed with entered reference values

 press “OK” in the right-hand bottom corner

 Main Screen – “Start”
- successive measurements from the pre-defined list of control plasmas begin

After the completion of measurements a working list with measurement results is

displayed and possible fast printing (key: ”Print result”).

5.4.2. PROGRAMMING.
Option of “PROGRAMMING” / / is designed to adjust the analyzer parameters of
measurement and settings to user’s demands.
In order for a new program to be present on the list of programs to perform assays
the following must be done:
 have measurement methods (methods are provided by the analyzer
manufacturer)
 assign individual name to the measurement
 program and save selected measurement parameters
 enter the program in the appropriate set of tests
 perform calibration

The user enters from the keyboard or selects from the opening list the following
parameters:
- individual name for the created program (“New”)
- selected methods
- selected type of result
- selection: “Single or double measurement”

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- entering the coefficient of variation Cvmax % for double measurements
- selection: “whether to repeat the measurement if the Cv% coefficient obtained
in a double measurement is higher than the entered C vmax %”
- enter the reference range
- selection (only for a single measurement): “whether to repeat the measurement
if the result is beyond the reference range”
- option: “Advanced settings” which enables initial dilutions of tested material
(application mainly for D-Dimers)

5.4.2.1. Creating a new program (example for the determination of

fibrinogen by Clauss):
A. From the main screen select “PROGRAMMING” and accept
B. Select the key “New”
C. Enter your name of the measurement, e.g., “Fib.Clauss” and accept with the
key “Enter”:

D. Select method from the list of methods:

E. Save
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F. In active fields of the screen (white fields) select or enter required

measurement parameters:

Fib. Clauss

Fibrinogen Clauss

 Select type of result:

- selected (highlighted green) – the result will be calculated and
issued by the analyzer
- selected (crossed out grey) – the result will not be calculated or
issued
 enter reference range (standards)
 select single or double measurement
 for selected single measurement:
- choose whether the automatic repeat of measurement must be
performed for a result within the critical values (at the end the result of
the second measurement is given)
 for selected double measurement:
- enter maximum coefficient of variation CV% between double
measurements
- select if automatic repetition of the measurement for exceeded
coefficient of variation CV% between double measurements is to be
performed (at the end, the result from the second double is given)

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G. Define the field “currently used”
- selected (highlighted green) means that the program will be
displayed in the list of programs for patients’ measurements. At the
same time, it is a network program, i.e., tests ordered by the
laboratory network are performed by the program. Only one program
from the group (e.g., 1 Fibrinogen) may be currently used
- selected (crossed out grey) – the program will not be displayed in
the list of programs for patients, but it will be stored in the analyzer
memory. The intention is to hide unused (but recorded) programs from
individuals who currently operate the analyzer.

H. Option “Advanced settings” using this option is required when the expected
fibrinogen concentration (measured by the method of Clauss) is higher than the
fibrinogen measurement linearity limit for this method (approximately 4,5 g/l).
After the screen “Starting dilutions” is displayed, select the option “set default
values”. The analyzer program offers (as a default) one dilution 1:2. The user
may change the default dilution to another one according to the needs.

Programming measurements in the field “Advanced settings”

For fibrinogen concentration >4,5 g/l an additional measurement will be performed
after diluting the sample 1:2.

I. Press the key “Sets” and add the created program to the proper set (see pt.
5.4.2.2.).

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5.4.2.2. Measurement sets.

Each newly-created program must be assigned to the proper set of programs. The
purpose of the procedure is to avoid a possible conflict due the limited number of
places for reagents, buffers, diluents, etc, in the reagents tray and refrigerator
block. Active set number and programs it includes are highlighted in white colour.
The analyzer program analyzes the created set and checks if there are enough
places. At the same time, “Sets of programs” shows which places in the tray and in
the block will be taken (green colour) and which will remain free (grey colour). If
there is a conflict (no place), a proper message will be displayed and the reagent
position will change to red. Follow the message instructions and select another set
for the newly created program.

Screen “Program Sets”. There is no conflict of place. Set 2 is shown as well as

programs it includes (white colour). All places for reagents and liquids are taken,
which is marked in green.

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Screen “Program Sets”. There is a conflict of no place for the reagent. One or more
programs must be moved to another set.

5.4.2.3. Screen “Programming” - example for APPT :

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5.4.2.4. Screen “Programming” - example for AT III :

5.4.2.5. Screens “Programming” - example for D-Dimer:

a) screen “Programming”

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b) field “Advanced settings” allows to enter a special screen where it is possible to
program any further dilutions of the tested sample. Such cases may occur, e.g.,
for high concentrations of sample or if the sample may contain substances (e.g.,
drugs) disturbing the measurement (this most often happens for D-Dimer).

Screen "Programming" - "Advanced Settings"

The analyzer programme executes proper dilutions and calculations without the
user's intervention.
The option "Starter dilution" allows us to set one of the two possibilities:
- measurement without dilution (100%) or
- measurement with dilution 1:2 (50%) means that all plasmas prior to
measurement shall be diluted twice, and the result will given after they are
multiplied by 2. Starter dilution 1:2 will cause the increase of a lower limit of
linearity to the value twice as much higher, e.g. instead of 250 ug/l there will be
500ug/l
After switching on the option "Further dilutions" the analyzer will automatically
dilute the initial sample in accordance with the values entered in the tables.
Example – the values entered in the tables as above.
If the concentration of the initial sample is higher than 3200ug/l (here the value of
the calibrator is entered - linearity of the result) the analyzer programme dilutes
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the sample 1:3 (33%).
If the sample diluted three times has a value higher than 3200ug/l, (without
multiplication it by the dilution ratio) the analyzer will automatically move on to
dilute the initial sample - 1:6 (16.6%). If after this step the result (without
multiplication) is lower than 3200ug/l, then the analyzer does not perform the next
dilution (here 1:10); it only multiples the result obtained by the dilution ratio (here
6x) and gives the final result.
For assaying D-Dimer it is recommended to find a compromise between the
economy of tests and a doctor's needs. If we expect a high D-Dimer result, it is
more cost-saving to dilute a patient's plasma on one's own, for example 1:10 and
place this plasma in an Eppendorf round-bottomed test-tube as a tested sample
rather that allow the analyzer to perform a series of five expensive dilutions.
If we do not know what D-Dimer result is expected, and we have obtained the
result 0 ug/l without dilution, then the test must be repeated with dilution, for
example 1:2

5.4.3. CALIBRATION.
Option “Calibration” enables to introduce reference values from calibration plasma
assays to the analyzer program.
Calibration is always performed following the change of reagents’ lots or when
control assays are not correct.
Reference values are used by the analyzer program to effect proper calculations
and provide final result.

Notes:
1. Reference values read from other manufacturers’ reagent brochures
cannot be entered into the analyzer “bioksel 6000” !
2. After the completion of calibration make a record of achieved values of
calibration measurements (print or write down manually from the
screen)

Performing calibration – example for PT and Fibrinogen PT

Reagents used:
Bio-Ksel System PT Cat. number 843 521
Bio-Ksel System Fibrynogen Rozcieńczalnik
Cat. number 843 742
/Fibrinogen Diluent/
Bio-Ksel System Kalibrator /Calibrator/ Cat. number 843 001

 prepare reagents and reference material in accordance with the manufacturer’s

recommendations
 on the Main Screen press the key “Calibration”
 from the list of programs select the program intended for calibration, e.g., PT
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 - screen with data from previous calibration is displayed

 click the green button “Calibration”

 fill in fields in the screen according to reagents’ brochures
 key “Continue”
 in window C1 enter fibrinogen baseline concentration (from the calibrator
brochure)
 pull down the list of dilutions
 re-enter the previously selected position number
 select another dilution for the calibration curve
 key “Start” - calibration measurements begin

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Note:
After calibration measurements for all points of the curve, the analyzer program
calculates the correlation coefficient “r”. If “r”>0,995, the curve is correct:
 “Accept calibration”
or:
 “Reject calibration” and repeat activities for calibration.

If calibration parameters have been entered manually from the keyboard, (key
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“Edit”) on the printouts of program parameters and printouts of patients’ results
there will appear characters “ ######## ” indicating that there has been
interference in calibration measurements.

5.4.4. Results.
Table 4.
Types of results for chronometric assays.

Type of result Application Calculations

Time (sec.) TT

time for correct plasma x 100%

PT index PT
time for tested plasma

APTT, TT time for tested plasma

RATIO
time for correct plasma

ISI
INR PT (RATIO)

Option “RESULTS” enables:

a) to print,
b) to view,
c) to send to computer network, patients’ results and quality control results stored
in the analyzer memory.
d) Report - printing found results as a report
e) Instructing Party - printing a report from tests performed for a selected principal
f) to delete results from the analyzer memory (patients’ results and quality control
results).

5.4.4.1. Searching for patients’ results.

5.4.4.1.a) Searching and viewing results

Results may be searched according to the following criteria:

Criterion Description Notes

Number Patient’s number
Day is from 00.00 hours to
Date Date of assay
23.59 hours
Referring entity Given when entering patient’s data
Pesel /personal
identification Patient’s pesel
number/
First name Patient’s first name
Surname Patient’s surname

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Notes:
1. The range of dates must be given as a minimum search criterion
2. Specification of additional criteria - one or a few will narrow down the result
of the search
3. If more than 1 search criterion is given (e.g., PESEL, surname, first name,
referring entity, etc.), all these data must comply with the data entered when
making the patients’ list (size of letters, spaces, dots, dashes, etc., must be
compliant as well). Otherwise the result will not be found.

4. If no result has been found, that means that incorrect search criteria have been
given. Enter the data again.

5. If you provide one day as the date range

(e.g., from 29.01.2015 to 29.01.2015), the hours range or the whole day from
00.00 hours to 23.59 hours must be provided.

a) Searching for results

 find Main Screen

 tab “Results”

 open bookmark "Patients"

 enter date range compulsorily (e.g., whole year). If we enter one day as the
date range, hours must be given (e.g., whole day from 00.00 hours to 23.59
hours)

 enter search criterion. If the search is to be effected according to one criterion

only, other fields should be left white – not filled in (apart from the date
range). White fields, which are not filled in, are disregarded by the search
engine.
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 key “Search” - results will be displayed on the green background of the screen

5.4.4.1.b) Printing of results

Fast printing of current results, with no search, no sorting and without entering
the option “Results”.

First results (achieved from measurements of the current list of patients) are
displayed on the right-hand side of the screen after the completion of
measurements. The results may be printed by clicking the key “Print results”. All
results from the list will be printed. In this option it is not possible to select the
result of only 1 patient to print.
Printing from the tab “Results” – results from the memory of the analyzer will
be printed.

 search for the result or results according to pt. a) – results will be displayed
against the green background
 key “Print” - all results from the screen will be printed

5.4.4.1.c) Sending the results to a computer network

 search for a result or results under item a)

 the key "Transmission" - all the results displayed on the screen will be
transmitted

5.4.4.1.d) Report – printing found results as a report

5.4.4.1.e) Instructing Party - printing a report from tests performed for a

selected principal

5.4.4.1.f) Deletion of results

(only users authorised by the Administrator to delete results)

 search for a result or results under item a)

 the key "Delete all" (the key will appear only for the users authorised to
delete results)
- all the results displayed on the screen will be transmitted

5.4.4.2. Searching for and graphic printing of quality

control results. Levey-Jennings chart.

 find the Main Screen,  tab “Results”,  tab “Control”

 enter date range compulsorily (e.g., whole year). If you enter one day as the
date range, hours must be given (e.g., whole day from 00.00 hours to 23.59
hours)

 enter the name of control plasma (not compulsory)

All these data must comply with the data entered when making the list of control
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plasmas (size of letters, spaces, dots, dashes, etc., must be compliant as well).
Otherwise the result will not be found.

 key “Search”

- results will be displayed against the green background of the screen

- button “Chart” – from the window select the data to be displayed
on the Levey-Jennings chart  “OK” – a chart is displayed which may be
printed

5.4.5. Technical program.

Option “Technical program” (see upper row of buttons on the Main Screen) is
designed for maintenance activities, entering the laboratory name and checking
technical parameters of the analyzer by the service.

The following activities are accessible for the user from the screen “Technical
program”:

5.4.5.1. Deaeration
Deaeration (combined with rinsing) serves to remove air molecules from the
rinsing liquid hoses.
Check if the container is filled with the liquid. Press the key “Deaeration”. Automatic
deaeration cycle begins lasting for a few minutes. Deaeration is more effective if,
prior to the cycle, the hoses are moved by hitting softly.

5.4.5.2. Washing the needles

Put the washing liquid into the block - position 10 and position B in the plasma
tray). Check if the container is filled with the rinsing liquid. Press the key “Washing
the needles”. Automatic washing cycle begins lasting for a few minutes.

5.4.5.3. Measurements mode (available since version v3.10)

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Option to select the sequence of measurements by the analyzer. Pressing you can
choose one of two possibilities:

- the order of "Sequence of measurements according to – type of test"- will

be screened: first, all the tests PT, APTT, etc. The order then will be
determined by the order list in the "Programming" (see paragraph. 5.4.2.1.)

- the order of " Sequence of measurements according to – patients" - will be

made all the previously selected for the study No patient, then all the next
number of the patient, etc.

5.4.5.4. Transmission test (“Transmission”)

The option serves to test transmission and the analyzer - external network
connection. It may be performed after the manufacturer’s service connects, starts
and tests this option in collaboration with the company responsible for the
installation of the computer network.

5.4.5.5. Entering the laboratory name (“Laboratory name”)

The option serves to enter the laboratory data (e.g., name, address, telephone).
The data will be in the heading of the results printout. 4 lines are available, each
line has 40 characters. The virtual keyboard is displayed after clicking the green
field of the screen.
Other keys (“Tests”, “Methods”, “Channels”, “Settings”, “Database”) are designed
for the qualified service of the analyzer manufacturer and are not available for the
user (code must be provided)

5.4.6. Finishing operations of the analyzer.

If the analyzer does not work in continuous system (than is, it is disconnected from
power supply after finishing operations):
 remove reagents from the reagent block and place them in the refrigerator
 remove tested samples
 empty the container for used cups
 empty the wastewater container
 log off
 press the key “Finish operations”
 Wait for approximately 15 seconds for closing the systems shown as the
blank screen
 turn off the analyzer using the switch on the back panel
 cover the ananlyzer, especially the monitor if there are UV lamps on in the
room.

6. Error Messages and Removing Malfunctions

6.1. General remarks:
System of reagents and consumables is a closed system.
Only the Bio-Ksel System or Bio-Ksel EKO reagents, “Chrom” cups must be used as
Page 44 of 51
well as consumables recommended by the manufacturer of the analyzer.
Other reagents and consumables applied by the user will result in material damage
to the analyzer and loss of guarantee and warranty.
No test tubes for blood collection can be used without the prior approval by the
manufacturer of the analyzer.
In case of changing the type or model of test tubes, the manufacturer must be
absolutely consulted.
6.2. Malfunctions and their removal:
 Blinking sensor icons (lower row on the Main Screen) in the course of
operations and message describing the cause is displayed. A signal may sound.
This means that the analyzer is not ready to operate;
- remove the cause and press “Start” again.
 Blinking sensor icon “Wastewater” while the container is empty
- wet wastewater container plug short-circuits the level sensor electrodes.
Clean the container plug and wipe dry with a gauze on both sides of the plug.
 Message “No plasma” while the test tube with plasma is in the position;
- too high level of plasma (incorrectly collected material or inappropriate test
tube for material collection).

 Message “No test tubes” and sound signal in the course of the analyzer
operations
- press “OK”, replenish the cups tray, close the cover, press the key
“New test tube store”, confirm “Yes”, “OK”, press “Start”.
 Message “no reagent in position…” and sound signal.
- open the cover, replenish reagents, close the cover, “Start”
 Assay cup has not dropped from the holder – sound signal and message
“Cup error”
- open the cover and remove the cup attached to the holder
- clean the holder with the spirit
- blow through the cups openings in the measurement block
 Visible residues on needle ends
- wipe the ends with the spirit and rinse the needles
 Liquid drops stream down the needle ends
- leaks in the hydraulic system, check the quality and leak tightness of the
hoses, replace hoses in peristaltic pumps
 Hydraulic system frequently gets air-locked
- check tightness of liquid hoses (squashed or cracked)
- check if the hoses are well put on the ends

7. Maintenance of the Analyzer.

In order to perform maintenance:
 finish operations and switch off the analyzer using the switch on the back panel
 take out all test tubes, measuring cups and reagent bottles
 carriage with the needle block may be gently moved in order to gain access to
the measurement openings
 after completion of maintenance place the carriage in such a way that the

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 needles are placed over the openings of the rinser
NOTES:
1. Dispensing needles are the most fragile elements of the analyzer.
2. During cleaning of a needle hold only its mounting mandrel
3. Handle the left needle very carefully (placed on the thicker mandrel) as its
moving causes the release from the lock and fall of the whole needle drive
down, which consequently may cause bending and damage to the needle.
4. Never allow the needle to rest on the measurement block or another element
of the analyzer console.

7.1. Periodic maintenance

Plexi surfaces must not be washed with an alcohol-based agent!
Perform maintenance and cleaning of accessible external surfaces of the analyzer
with a soft cloth and alcohol-free cleaning and disinfecting agents for cleaning
surfaces of medical equipment. Do not use solvents, spirits or abrasive agents.

7.1.1. Everyday maintenance

- check visually for residues on dispensing needles, clean with a gauze soaked
in the spirit if necessary
- other everyday maintenance operations are performed automatically by the
analyzer.
- wash the needles (pt 5.4.5.)

7.1.2. Weekly maintenance

Once a week:
- wipe the needles with a gauze soaked in the spirit
- check if the needle rinser openings are clean and in case they are soiled clean
with a cotton roll
Note! Only the middle opening of the rinser must be patent. Other openings –
on the left and right of the middle opening do not have outlet
openings in the bottom; however, they must always be kept clean.

- blow through the openings in the measurement block by means of a rubber

air puffer

Note! Do not clean measurement openings by putting gauzes or other objects

into them. Such cleaning is only permissible in consultation with the
authorised service
- take out, clean and wipe dry on both sides the plugs of the rinsing liquid
container and wastewater container. Wet or damp plug may produce a false
indication of a full container and false blinking of the fields “Wastewater” or
“Rinsing liquid” on the Main Screen

7.1.3. Monthly maintenance

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 Once a month:
- check and possibly replace the hoses of peristaltic pumps (pt.)
- check and clean the air filter (pt. 7.2.2.)

7.1.4. Half-year maintenance

- replacement of the air filter insert (pt. 7.2.2.)
- replacement of Teflon hoses of the hydraulic system (service or in
consultation with the service)

7.1.5. Technical inspections

The analyzer requires periodic technical inspections performed by the manufacturer
or authorised service (upon presenting authorisation document) on a half-year
basis. Inspection performed by other individuals or companies is not allowed.

7.2. Other maintenance and repair activities

Notes:
1. Always check visually if:
- the hoses with liquid are air locked
- the hoses in peristaltic pumps are used up (colour change, considerable
clearances, leaks of the liquid from needle ends)
2. Clean and disinfect the external surfaces of the analyzer with washing agents
with detergents and disinfecting agents for washing and disinfecting hands.
3. Clean the monitor screen with LCD screen cleaning agents.
4. In the case of a considerable amount of assays (over 300 daily), maintenance
activities should be performed after shorter periods of time.

7.2.1. Replacement of hoses in peristaltic pumps

Do the replacement successively in each pump. The other unbolted pump treat as
the example when replacing the hose in the first pump.
 Place the carriage with dispensing needles so that both needles are over the
rinser in order for the rinsing liquid to flow down after taking off the hoses in
pumps

NOTE: Do not allow for flooding any openings in the analyzer by the rinsing
liquid after taking off the hoses!
 unscrew the clamp on the hose with the enclosed Allen wrench (1 screw) and
turn it up to the right
 unscrew two screws of the mounting strip of the hose and take out the hose
from connecting pipes
 put a new hose on connecting pipes
 put the mounting strip and tighten it (2 screws)
 place horizontally and tighten the clamp on the hose (1 screw)

7.2.2. Replacement of air filters

The first air filters are located in the analyzer floor in the middle – under the front
panel of he housing (next to the container for used cups).
The next filter is located at the back of the analyzer by the sockets of outlet cables.
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In order to replace the filters:

 Finish operations and switch off the analyzer using the switch on the back panel
 Prise off with a screwdriver and take off the cover of filter insert
 Clean the insert or replace with a new one
 Put back the cover and make sure it snaps properly

7.2.3. Clogged needle or the so-called growth in the hoses of the hydraulic
system
 fill up the container for the rinsing liquid (at the back of the analyzer) with the
deproteinization liquid
 rinse several times and deaerate the hoses until the residue disappears
 remove the deproteinization liquid from the container, rinse the container well
and fill up with filling liquid
 rinse a few times and deaerate the hoses
 wash the needles a few times (pt 5.4.5.)- do not forget to put the washing
liquid into the opening in the measurement block and plasma tray – position “B”

7.2.4. Preparing the analyzer for a long break.

A long break from operations is a period of switching off the analyzer for more than
30 days.
 Finish operations and switch off the analyzer
 Make sure the two dispensing needles are placed over the rinsing opening
 Unscrew the clamp on the hoses in the pumps (see pt. 7.2.1.) with the Allen
wrench and slip off the hoses from the rolls
 Check if the liquid from the hoses has flown down to the rinsing opening
 Empty the wastewater container and rinsing liquid container
 Dry the needle ends and measuring cups holder with a gauze
 Put empty cups to the openings in the measurement block so that the
openings are protected against soiling
 Dry all the needle rinser openings with a swab
 Disinfect all accessible external surfaces, surfaces in the area of trays and
blocks, surfaces of test tube trays and reagents as well as surfaces of the
analyzer cooling block and measurement block according to pt. 7.1.

7.2.5. Starting up the analyzer after a long break.

 Put new hoses on the peristaltic pumps (if the clamp on the hose has not been
released before the break) or put the clamp on the hoses using the Allen
wrench
 Wash the ends of the dispensing needles and the cups holder with a gauze
soaked in the spirit
 Make sure the needle ends are patent and free from residues
 Take our empty cups from the openings of the measurement block
 Blow through the openings in the measurement block by means of a rubber
air puffer
 Put on and fill up the rinsing liquid container
 Wash the rinser of the dispensing needles
 Connect the wastewater container
 Switch on the analyzer
 Enter the tab “Technical programme” (on the Main Screen)
 Perform needles washing and deaeration several times (pt. 5.4.5.)

8. Procedure in Case of Voltage Interruption.

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If there is a risk of voltage interruption, the analyzer must be connected to the
power supply network by means of uninterruptible power supply (UPS) – See Figure
1.
After voltage interruption and acoustic signal from UPS:
- stop the analyzer operations by the key “STOP” (quickly press 2x)
- log off
- finish the analyzer operations using the key “Finish operations”
- wait approximately 15 seconds for closing the system which shows as blank
screen
- switch off the analyzer power supply using the switch on the back panel
- take out the tubes with tested material and reagents

9. Transmission of Results Analyzer – Computer Network.

Notes! Computer in control of the laboratory computer network must be
connected to the same phase of power supply 230V to which the
analyzer power strip is connected!

Manufacturer and provider of the network performs the connection of the analyzer
to the laboratory computer network after having received transmission protocol
from the analyzer manufacturer.
Operations described below should be performed once in consultation with the
manufacturer’s service or the computer network provider.
9.1. Setting transmission parameters.
 Switch on the analyzer
 Select the tab “Technical program” (on the Main Screen)
 Select the tab “Transmission” (accessible only to the user with the
Administrator’s privileges)

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 Select type of transmission:
- “Automatic transmission” – sending the results is effected after completing
all measurements for a given patient number
- “Manual transmission” – use the window “Results” (see “Main Screen”)
 Selection of type of transmission after completing an assay:
- “Complete result” – transmitted full set of assay results ordered for the
given plasma
- “Partial result” – transmitted single assay result for the given plasma
 “Time out” (network server) – is set by the network service
 "Speed of transmission” – is set by the network service
 “Active operations in the network” – turns on or off operations in the network
 "COM port status" - switches on or switches off the COM port - sets the
network service

10. Decommissionig the Analyzer in order to Repair it or

for Disposal.

10.1. Decommissioning the unit in order to make repair.

Perform the activities from pt 7.2.4. “Preparing the analyzer for a long break.”
10.2. Decommissioning the unit for disposal.
Perform activities from pt 7.2.4. “Preparing the analyzer for a long break.”
Transfer the analyzer to the manufacturer for recycling according to the Act on the
Used Electric and Electronic Equipment and the Act on Batteries and Accumulators.

11. Applied Symbols and Designations.

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 Temperature range
Lot number
To be used for In Vitro diagnostics
Use by (month and year)
Manufacturer
Calibrator
Control material
Use in accordance with the service manual
CE designation
Recyclable, do not throw away

12. Demand for Consumables.

Consumption
Catalogue Replacement after period
Consumables per
No. of consumption
1 assay

Rinsing liquid 843 771 ~ 3 ml -

Washing liquid 843 772 ~ 0.125 ml -

Chrom cup 843 00 1 pc. -

1 per month or after every

Pump hose 2 pcs. - -
1000 assays

Air filter insert 2 pcs. - - Every 6 months

Hydraulic system hoses

- - Every 6 months
(Teflon) 1 set

Container for used cups - - After 200 assays

13. Disposal of Used Consumables.

Used consumables (cups, test tubes with tested material, wastewater from the
container, reagents vials and cups, washing and rinsing liquid containers, hydraulic
system hoses and others) must be utilised in compliance with disposal procedure
implemented in the laboratory with reference to potentially infectious biological
material.

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