Analyzer 90
USER MANUAL
This manual contains DAS srl reserved information. All rights reserved. Unauthorized copying of this
manual or part of it is prohibited.
das srl
Viale Tivoli Km 18,642 – 00018 Palombara Sabina (Roma) - Italy
Tel. (+39) 0774 66840 – 0774 637070 - Fax 0774 634039
E-mail: inf o@dasitaly.com - http://www.dasitaly.com
Analyzer 90
USER MANUAL
Index
Indice
Date
Data
Description
Descrizione
Rev. 00
16.12.2005 Issue
Rev.01
Correction on maximum
length for assay name.
28.05.2007
Correction on maximum legth
for unit of measurement.
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Execution
Elaborazione
Verification
Verifica
Page 3
Approval
Approvazione
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 5
SOMMARIO
INTRODUCTION.................................................................................................................................................................7
0.1.
DESCRIPTION ......................................................................................................................................................7
0.2.
WARRANTY.........................................................................................................................................................7
0.2.1
Asking for service ..........................................................................................................................................7
0.2.2
Ordering spare parts .....................................................................................................................................7
0.3.
CE CONFORMITY................................................................................................................................................9
SECTION 1 - GENERAL SAFETY WARNINGS............................................................................................................. 11
1.1.
GENERAL SAFETY WARNINGS ....................................................................................................................... 11
1.2.
INSTRUMENT WORKING CONDITIONS .......................................................................................................... 11
1.3.
INTENDED USE OF THE INSTRUMENT ........................................................................................................... 11
SECTION 2 – GENERAL INFORMATION ..................................................................................................................... 13
2.1.
AIMS AND CHARACTERISTICS OF THE INSTRUMENT.................................................................................. 13
2.2.
MAIN FEATURES............................................................................................................................................... 13
2.3.
TECHNICAL FEATURES.................................................................................................................................... 13
SECTION 3 – INSTALLATION AND START UP ........................................................................................................... 15
3.1
PLACING INSTRUMENT ................................................................................................................................... 15
3.1.1.
Positioning the instrument ........................................................................................................................... 15
3.1.2.
Power connection......................................................................................................................................... 15
3.2.
ANALYZER 90− COMPUTER CONNECTION.................................................................................................... 15
3.3.
SET THE INSTRUMENT IN WORKING CONDITION ........................................................................................ 16
3.3.1.
How to insert the paper................................................................................................................................ 16
3.3.2.
Waste tank positioning................................................................................................................................. 16
SECTION 4 – OPERATING INSTRUCTIONS ................................................................................................................ 17
4.1.
OPERATING INSTRUCTIONS............................................................................................................................ 17
4.2.
SWITCHING THE INSTRUMENT ON................................................................................................................. 18
4.1.1.
Probe........................................................................................................................................................... 18
4.1.2.
Suction pump ............................................................................................................................................... 18
4.3.
MEASURE AND CALCULATION METHODS FOR ASSAYS ............................................................................. 19
4.3.1.
Absorbance method (ABS)............................................................................................................................ 19
4.3.2.
Concentration method.................................................................................................................................. 19
4.4.
INSTRUMENT SETTINGS.................................................................................................................................. 20
4.5.
ASSAY SET UP ................................................................................................................................................... 23
4.5.1.
ABS assay set up.......................................................................................................................................... 24
4.5.2.
CONCENTRATION assay set up .................................................................................................................. 24
4.5.3.
KINETIC assay set up.................................................................................................................................. 25
4.6.
ASSAY MODIFICATION .................................................................................................................................... 26
4.7.
ASSAY PROCESSING......................................................................................................................................... 27
4.7.1.
Assay Start Up............................................................................................................................................. 28
4.7.2.
How to carry out an ABS assay.................................................................................................................... 29
4.7.3.
How to carry out a CONCENTRATION assay .............................................................................................. 29
4.7.4.
How to carry out a KINETIC assay.............................................................................................................. 30
4.8.
SERVICE............................................................................................................................................................. 30
4.9.
TIMER FUNCTION ............................................................................................................................................. 31
SECTION 5 - MAINTENANCE......................................................................................................................................... 33
5.1.
MAINTENANCE AND CHECKS PREVENTIVE MEASURES ............................................................................ 33
5.1.1.
Cleaning ...................................................................................................................................................... 33
5.1.2.
Flow cell cleaning........................................................................................................................................ 34
5.1.3.
Instrument tests............................................................................................................................................ 34
5.1.4.
Inspection and controls................................................................................................................................ 34
5.1.5.
Troubleshooting (Diagnosis)........................................................................................................................ 35
5.2.
REPAIRS ............................................................................................................................................................. 35
SECTION 6 - PACKING, TRANSPORTATION AND STORING .................................................................................. 37
6.1.
GENERALITY..................................................................................................................................................... 37
6.2.
PACKING THE INSTRUMENT ........................................................................................................................... 37
6.3.
TRANSPORTATION........................................................................................................................................... 37
6.4.
STORING THE INSTRUMENT ........................................................................................................................... 37
SECTION 7 – APPENDIX ................................................................................................................................................. 39
APPENDIX A................................................................................................................................................................... 39
A.1.
INSTRUMENT DECONTAMINATION. .............................................................................................................. 39
A.1.1.
Decontamination procedure......................................................................................................................... 39
A.1.2.
Decontamination declaration....................................................................................................................... 40
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 7
INTRODUCTION
0.1. DESCRIPTION
This manual provides the operator with all the necessary instructions and maintenance recommendations
for a safe and suitable use of the instrument.
Manual content:
−
introduction - warranty information, Technical Service and the CE conformity declaration
−
section 1 - general safety-warnings
−
section 2 - general information
−
section 3 - instrument performance and technical data
−
section 4 - installation and start up
−
section 5 - operating instructions
−
section 6 - periodic maintenance
−
section 7 - how to put the instrument out of service, packaging, transport and storage
−
section 8 - appendices including instrument decontamination and spare parts list
This manual is considered as a part of the instrument; it has to be at the operator, user ,and maintenance
technician’s hand at any time. For accurate installation, use and maintenance please read the following
instructions carefully.
In particular carefully read Section 1 “GENERAL SAFETY WARNINGS”, describing the suitable operating
procedures in order to avoid damages to the instrument and people.
In case of breakdowns or any troubles with the instrument, refer to the local Technical Service.
0.2. WARRANTY
Each provided instrument is completely tested, and guaranteed for twelve months from delivery.
The warranty is for all mechanical and electrical parts. It is granted only for a proper installation, use and
maintenance in compliance to the given instructions contained in this manual.
The warranty does not include any responsibility for direct or indirect to people and material damages,
caused by improper use and maintenance of the instrument.
All parts that are subject to deterioration, because of their specific use, are excluded from the warranty.
Due to a misuse of the instrument the above mentioned warranty does not include (if requested) the travel
and labor-hour expenses as well as all the accommodation expenses.
0.2.1 Asking for service
When asking for service, refer to this manual indicating also the data reported on the identification label of
the instrument.
Only qualified Technicians with suitable instrumentation and original spare parts are entitled to fix the
instrument; ordinary maintenance should be carried out by the user, as described in this manual.
0.2.2 Ordering spare parts
Parts that are subject to deterioration or that are defective and need to be replaced have to be requested
as shown below.
When ordering spare parts, the following details are to be mentioned:
− customer’s purchase order
− name and version of the instrument
− instrument code number
− part code number
− part description
− requested quantity
− name and company address to deliver the ordered goods
Replacing the parts with ORIGINAL SPARE PARTS guarantees effective and lasting instrument life
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Page 9
0.3. CE CONFORMITY
Declaration of conformity according to the 98/79/EC
In-Vitro Diagnostic medical devices Directive (IVDD)
DAS srl, manufacturer of the Clinical Chemistry Photometer “Analyzer 90”, A2 model, class of risk InVitro Diagnostic Medical Devices, declares that the mentioned instrument complies with the European
Directive 98/79/EC (IVDD).
The present conformity declaration, as stated in Annex III of the 98/79/EC Directive, is based upon the
following requirements:
Quality Management System (ISO 9001:2000): Working Procedures and Instructions for
• Design process control;
• Manufacturing process control;
• Tests and Checks.
System documentation:
• Technical documents;
• Risk analysis;
• User manual;
• Service manual.
th
Palombara Sabina, November 15 , 2003
Mario Orsini
Managing Director
The instrument conforms to the following EC Directives, including the last modifications:
−
98/79/EC regarding in-vitro diagnostic medical devices
−
73/23/EC regarding low voltage
−
89/336/EC regarding Electromagnetic Compatibility
The below harmonized standard specifications have been applied:
Quality system:
EN ISO 9001:2000 “Quality management systems”
Risk analysis:
EN 14971 (2000) “Application of risk management to medical devices”
Safety:
EN 61010 -1 (1997) “Electrical equipment safety requirements for measurement, control and laboratory use
– Part 1: General requirements”
Electromagnetic Compatibility:
EN 61326 -1 (1998) “Electrical equipment for measurement, control and laboratory use – EMC
requirements – Part 1: General requirements”.
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SECTION 1 - GENERAL SAFETY WARNINGS
1.1. GENERAL SAFETY WARNINGS
In this manual the following symbols stand for danger or warnings:
General DANGER symbol. Indicates that not following relative instructions and warnings is a
serious safety risk.
Indicates ELECTRICAL VOLTAGE, which could cause death upon contact. Covers with this
symbol can be removed and replaced by qualified people and only after electrical power
disconnection.
Indicates that the instrument uses reagents and other DANGEROUS CHEMICAL SUBSTANCES,
corrosive, irritating or noxious, which could cause health damages.
Indicates that the instrument handles potentially infectious samples (e.g. body fluids such as urine)
which could cause INFECTION/CONTAMINATION. Always observe the general safety standard
rules for the presence of these biological substances. Wear protective goggles, gloves and
clothing.
Indicates that not following the correct instructions could cause damage to the instrument and/or its
proper functioning.
Indicates important information concerning the instrument or a section of the document that is
important to read with particular attention.
1.2. INSTRUMENT WORKING CONDITIONS
The instrument is an in vitro diagnostic medical device (IVD) intended to be used in the following working
conditions:
− optical density readings as specified in the technical data
− use of the chemical reagents and accessories supplied and/or declared to be compatible
with the instrument
− working at a specific temperature and humidity level according to the details given in this
manual
− do not power the instrument in a potentially explosive or fire hazardous environment
The instrument has to be used as described in this manual. Any other use has to be regarded as
improper
1.3. INTENDED USE OF THE INSTRUMENT
The instrument has to be used for the expected purpose and in perfect technical conditions, by qualified
personnel, in working conditions and following maintenance operations described in this manual.
This manual contains instructions for qualified operators.
−
−
Qualified Users have to make sure that the environment conditions are suitable, the
installation is correct, the use and maintenance are proper, according to the general
safety rules as well as to particular precautions described in the manual (although he is
not entitled to repair the instrument).
Qualified Technicians are entitled to service and fix the instrument with original spare
parts, according to the received instructions.
Modifications of the instrument are not allowed. The user is liable for any improper
modifications and for the consequences deriving from them.
For extraordinary maintenance, ask for licensed service centers. The maintenance will be carried
out by Specialized Technicians that will be able to fix the instrument using original spare parts.
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SECTION 2 – GENERAL INFORMATION
2.1. AIMS AND CHARACTERISTICS OF THE INSTRUMENT
ANALYZER 90 is a photometer operating in the visible range. The instrument is an open photometer suitable for
absorbance (optical density) measures as well as sample concentration determination. It has an user-friendly
program and capacity of storing in its own memory the programmed analytical methods and the assay results.
2.2. MAIN FEATURES
Principle
Photometric reading
Type of instrument
Stand alone instrument, with internal software, keyboard, alphanumeric LCD-display, built-in
printer
Use
Clinical chemistry test reader
2.3. TECHNICAL FEATURES
Accuracy
± 1% from 0.000 to 1.500 OD
± 2% from 1.500 to 3.000 OD
Stability
0.01 OD in 8 hours
Light source
halogen lamp
Optical filters
340, 405, 492, 510, 546, 578, 630 nm
Detector
silicon photodiode
Reading path
10 mm
Flow-cell
80 µl
Flow-cell temp
room temp. 25/30/37°C ± 0.1 °C
Sample Aspiration
automated sample aspiration through a precision peristaltic pump
Sample volume
minimum 350 µl
Memory capacity
200 test and curves; the last 300 printable readings
Reading system
mono and bichromatic reading
Fast reading
for kinetic and fixed time
Calculation Mode
optical density, concentration, end-point against standard or factor, fix-time against
standard or factor, kinetic, non linear multi-standard curve up to 8 points, sample blank,
reagent blank
Calibration
from 2 to 8 points curve
Calendar/Timer
associates time with the results; timer function
Keypad
17 buttons
Display
2 lines with 16 columns
Printer
40 columns with thermal paper
Interface
RS232 serial port
Warm up Time
15 minutes
Power requirements
230/115 VAC, 50-60 Hz, 110 W
Measurements
cm 42 x 34 x 15 h
Weight
9 Kg
INSTRUMENT
EQUIPMENT
- A.C. power Cable
- User Manual
- Thermal paper roll (1 piece)
- Fuses Kit
- Dust cover
Additional accessories (optional):
- PC cable connection
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SECTION 3 – INSTALLATION AND START UP
When installing and setting up the instrument, follow the safety warnings and general rules
described in Section 1.
3.1
PLACING INSTRUMENT
3.1.1. Positioning the instrument
The instrument has to be placed on a leveled bench, assuring enough free space around the instrument to
allow maintenance operations. The instrument has to be kept in a room where temperature has to
o
be between 15 and 35 C with relative humidity below 80%, and protected from direct sun light.
3.1.2. Power connection
Once the instrument has been placed in the desired position proceed with plugging it into the right power
source 230VAC or 115VAC (see label) using the proper cable.
Warning: make sure that the electrical power is the one as requested and indicated on the
identification label of the instrument !
Warning: make sure that the fuses correspond to the ones indicated on the identification label of the
instrument and in the manual!
230 Vac
n° 2 quick fuses 3 A
115 Vac
n° 2 quick fuses 6 A
3.2. ANALYZER 90− COMPUTER CONNECTION
An optional connection cable and can be delivered with the instrument, in order to communicate with a PC for data
transferring, recording and printing.
It’s possible to use different communication programs, just be sure the following parameters are set:
•
8 bit
•
600 baud rate
•
no parity
•
stop bit
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3.3. SET THE INSTRUMENT IN WORKING CONDITION
3.3.1. How to insert the paper
Insert the roll of thermal paper in the specially provided seat, paying attention to put the heat sensitive
side of the paper facing down (usually the heat sensitive side of thermal paper is sleeker than the other
side).
Cut in regular way (if possible with scissors) the extremity of the paper and insert it in the special slot of
the printer, pressing simultaneously PAPER button; In order to simplify the inserting of a new roll, each
time that initial menu is visualized on the display, PAPER button enables paper advancement of 6 lines
instead of one.
Note: for the best printing results we recommend the use of original paper.
3.3.2. Waste tank positioning
The instrument has been programmed assuming that a sample volume (of 650 µl) is sucked for the
assay, and then discharged in the waste tank with additional cleaning distilled water .
Push button
PROBE
Yellow
FLOW
CELL
Red
SAMPLE
SUCTION
PUMP
Red
WASTE
WASTE TANK
fig. 4.4
Locate the waste tank close to the instrument, making sure that the discharging tube is properly inserted
and secured.
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SECTION 4 – OPERATING INSTRUCTIONS
4.1. OPERATING INSTRUCTIONS
The following flow diagram indicates how the instrument is used. Detailed information for each block can
be found in the indicated paragraph.
INITIAL MENU
SET
F1
F2
DATE
ASSAY
Hour - Min. - Sec.
Setup
TIME
ASSAY SET UP
AUTOMATIC
PRINT
ASSAY MODIFY
AUTOMATIC
NEXT
RUN ASSAY
WASHING
REQUEST
KINETIC
SETTING
FIXED TIME SET
PRINTING DATA
MEASURE TYPE
MEASURE
VOLUME
DELETE ASSAY
SERVICE
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4.2. SWITCHING THE INSTRUMENT ON
The safety warning and general rules described in Section 1 have to be observed when using the
instrument
When switched on, the instrument automatically checks
the functionality of its main parts; it prints the heading
containing the instrument name, the software revision,
the actual date and time.
Then the initial menu is shown as in fig. 1
Select one of the two options as shown on the display
lower line (ASSAY or TIMER) by pressing the function
keys F1 or F2
dd/mm/yy hh:mm
ASSAY
TIMER
F1
F2
1
2
3
4
ESC
5
6
7
8
SET
9
0
When this initial menu is displayed the SET and PAPER buttons assume specific functions:
• SET button is to modify some parameters (for example date and hour, as specified in the SET menu
chapter);
• PAPER button enables a longer advancement to make easier its initial insertion (see “Paper Insertion” in
Section 4).
• ENTER button when in this menu is not enabled (usually it allows to enter data when required on the
specific menu).
• ESC allows to go back to the previous menu
NOTE: SET, PAPER and ENTER, in particular menus can change their function as after explained.
4.1.1. Probe
The instrument is provided with a probe to suck the sample into the flow cell. The push button “FILL” has to be
pressed to activate the suction pump.
4.1.2. Suction pump
The instrument is provided with a peristaltic suction pump. The suction pump is activated by the push button
“FILL”.
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4.3. MEASURE AND CALCULATION METHODS FOR ASSAYS
4.3.1. Absorbance method (ABS)
The instrument measures just the sample absorbance without any calculation aiming to determine the
concentration. It’s possible to have a measure in monochromatic or bichromatic way, at different
wavelengths.
4.3.2. Concentration method
4.3.2.1. Absorbance reading
There are three different ways to read absorbance:
12. “End point” method:
Absorbance is read at the end of a specific delay time.
13. “Fixed time” method: divided in Standard or Fast
−
−
Standard
The instrument measures the sample ABS, twice in a specific delta time. After that, the
difference of the two readings is calculated as:
∆ = OD1 – OD0
Fast
the instrument continuously reads the sample ABS (5 readings per second), for a
defined time (Measure time). After that, the following parameters will be calculated:
−
−
−
angular coefficient (m),
Y axis intersection point (b),
Linear correlation coefficient ( r);
these three parameters appears on the printer together with the relative delta, calculated
on the delta time as in “Standard” method; they are used to calculate the result.
14. “Kinetic” method: divided in Standard or Fast
−
Standard
the instrument measures for n times (choosen by the operator) the sample ABS in a
defined delta time. For each delta time the instrument calculates the ABS difference ∆n
∆1 = OD1 – OD0
∆2 = OD2 – OD1
∆3 = OD3 – OD2
…
∆n = ODn – ODn-1
At the end of all readings, the average difference is calculated.
−
Fast
the instrument continuously reads the sample ABS (5 readings per second), for a
defined time (Measure time). After that, the following parameters will be calculated:
−
angular coefficient (m),
−
Y axis intersection point (b),
−
Linear correlation coefficient ( r)
these three parameters appears on the printer; they are used to calculate the result on
one minute.
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4.3.2.2.
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Concentration calculation
There are three different ways to calculate the concentration:
1.
Factor mode
The instrument calculates the concentration by multiplying the sample absorbance for a factor
choosen by the operator.
Sample CONC = FACTOR x Sample OD
2.
OneCal mode
The instrument calculates the concentration multiplying the sample absorbance by the ratio
between the calibrator concentration and the calibrator optical density:
Sample CONC = Sample OD X Calibrator CONC / Calibrator OD
3.
Curve mode
The instrument measures the absorbance of a certain number of standards (from 2 to 7) with
known concentration. A point to point curve is calculated and stored in memory. The sample
concentration is calculated on this curve.
For all these methods, the instrument shows the result using concentration units choosen by the operator.
4.4. INSTRUMENT SETTINGS
Date
to modify the instrument internal Date.
Time
to modify the instrument internal Time.
Automatic print
to set up the sample assay results automatic printing. In case this set up has not
been done, after every assay, the program asks confirmation for printing.
Automatic next
After samples reading and result printing, automatically asks to insert the following
sample.
Washing request
After samples reading, a washing is always performed.
Kinetic setting
Selects for the kinetic method the measurement approach: standard or fast.
Fixed time setting
Selects for the fixed time method the measurement approach: standard or fast.
Printing data
to print last 300 results of all the assays that have been made in a given/selectable
day. It is possible to print directly on the instrument printer or send out data via serial
port RS232
Measure type
Allows to read the sample by aspirating from the cell or a specific cup. In this last
case the reading cell has to be substituted with a specific cup holder
Note: the "cup" option is allowed only if the specifc kit (selled separetely) is mounted.
Measure volume
to set up the sample volume to be sucked (default value 650 µl) See note below.
Purge volume
to set up the purge volume to be discarded (default value 3000 µl)
Delete assay
to delete one or all stored assays
Service
to run functional tests and to get useful information for service
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IMPORTANT NOTE on Setting the “Measure Volume” parameter
The minimum required volume for a correct reading is 350 µl volume. Anyway, even if you have to read a very
small sample (for example 350 µl, or 500 µl), the “MEASURE VOLUME” parameter (the volume that will be
aspirated by the instrument) must be set to a greater value, (the default value is 650 µl). With this settings, the
instrument will first aspirate the whole sample and then some air: as you can see in fig. 1, the sample to be read
will have correctly reached the flow cell.
Flow cell
waste tubing
Flow cell
FILL key
Yellow
Waste tubing
Red
Peristaltic
pump
Red
Flow cell
wash tubing
PROBE
Waste tank
Sample
Figure 1: Correct reading conditions
Generally speaking, when setting the “MEASURE VOLUME” parameter on the instrument, the tubing preceding the
flow cell has to be considered. Its capacity is about 440 µl. The flow cell capacity, as declared in the technical
features, is 80 µl. In order to set reliable measuring conditions, it is necessary to “prime” the flow cell hydraulic
circuit. In such a condition, the flow cell will be completely filled with sample, there will be some sample before the
cell and some sample after the cell. For example, setting up a “MEASURE VOLUME” of 650 µl and having a 350 µl
sample, the liquid volume will be distributed as follows:
about 130 µl before the cell,
about 80 µl into the cell,
about 130 µl after the cell.
You can at any time set up a greater or a smaller value for the “MEASURE VOLUME” parameter, depending on
your needs. However, pay attention to the two notes that follow (see figures 2 and 3).
No matter the available volume, if you let the instrument aspirate less than 650 µl (for example, 500 µl), the liquid
in the sample cup wouldn’t “prime” (reach, fill and go over) the cell, as in fig. 2, and the instrument reading could
be unstable.
Flow cell
waste tubing
Flow cell
FILL key
Yellow
Waste tubing
Red
Peristaltic
pump
Red
Flow cell
wash tubing
PROBE
Waste tank
Sample
Figure 2: “Measure volume” too low
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If the available sample volume is very small, be careful not to aspirate too much: the sample could get over the
cell. For example, if you have only 350 µl in the cup, setting a 1000 µl “MEASURE VOLUME” would give an
incorrect reading, as shown in fig. 3.
Flow cell
waste tubing
Flow cell
FILL key
Yellow
Waste tubing
Red
Peristaltic
pump
Red
Flow cell
wash tubing
PROBE
Waste tank
Sample
Figure 3: “Measure volume” too high
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4.5. ASSAY SET UP
gg/mm/aa
hh:mm
ASSAY
TIMER
----------------------F1
From Main menu press F1 to Select assay .
F2
F1
Press F1 to select assay by number.
Press F2 to select assay from the list.
SELECT ASSAY
number
list
----------------------F1
F2
F2
F1
Press F1 or F2 to select a free position.
va alla prima posizione
libera della lista
ENTER NUMBER:_
(0 for printout)
----------------------F1
F2
N. 1 FREE
ENTER
next
previous
----------------------F1
Press F2 a new assay can be set up .
N.1 FREE
set
----------------------F1
First of all, the name of the new assay has to be entered.
Enter assay name with F1 and F2 keys to select digits
and/or letters (10 characters max).
Press SET to accept a letter and to shift to the next one.
Once the assay name has been typed, press ENTER.
F2
ENTER
F2
F2
NAME = ________
incr
decr
----------------------F1
F2
ENTER
Then the display will appear to choose for the assay
method to carry out.
1: ABS 2: CONC
3: KINETIC
Press 1 for ABS
Press 2 for CONCENTRATION
1
2
3
ABS
CONC
KINETIC
Press 3 for KINETIC
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4.5.1. ABS assay set up
a.
Select the primary filter pressing F1/F2 and press enter to accept
b.
Select the secondary filter pressing F1/F2 and press enter to accept
c.
Select the cell temperature pressing F1/F2 and press enter to accept
d.
Record the sample volume (µl) as memorandum
e.
Record the reagent volume (µl) as memorandum
4.5.2. CONCENTRATION assay set up
a.
Select the applicable calculation method:
1 ONECAL
2 CURVE
3 FACTOR
a1.
ONECAL
Insert Calibrator concentration value
a2.
CURVE
Insert the calibrator total number and the related concentration for each
calibrator
a3.
FACTOR
Insert the multiplying factor
b.
Record the incubation time as memorandum
Insert delay time (sec) before the reading takes place. If, from FIXED TIME
SET menu, fast mode is selected, the reading will take place after the time
settled in the WAITING TIME menu.
Select reading method:
c.
d.
1)
FIXED TIME: two 2 readings at fixed time (DELTA TIME) take place
and the difference is calculated. If from FIXED TIME SET menu, is
selected fast method, then the length of the reading will be as
REDING TIME settled.
2)
END POINT: only one reading take place on a fixed time (DELAY
TIME
d1.
FIXED TIME
Insert the delta time (time between the two readings)
d2.
END POINT
Select if the reading has to be :
- differential sample (F1) → a white reading is required for every sample
- direct sample reading (F2)
e.
Select the primary filter pressing F1/F2 and press ENTER to accept
f.
Select the secondary filter pressing F1/F2 and press ENTER to accept
g.
Select the cell temperature pressing F1/F2 and press ENTER to accept
h.
Insert measure unit typing the characters (max 6) and pressing ENTER
m.
Record as memorandum the minimum and maximum expected value
n.
Record as memorandum the sample and reagent volumes
Choice if the blank reagent has to be executed. If yes is selected, insert the
acceptance min and max value..
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Analyzer 90
USER MANUAL
Page 25
4.5.3. KINETIC assay set up
a.
Standard reading method.
Insert the delay time in seconds before reading take place. If from the
KINETINC SETTING menu fast method is selected, the reading will take
place after the time settled in the WAITING TIME menu.
Insert the delta time (waiting between 2 readings). If from the KINETINC
SETTING menu fast method is selected, the duration of the reading will be
like the one settled in the READING TIME menu.
Insert the number of readings (2 minimum). In the fast method this
parameter is not considered.
Fast reading method
a1.
a2.
a3.
b.
b1.
Insert the waiting time (sec):time to wait before reading start.
b2.
Insert the measure time (sec): time interval in witch measure are performed
every 200 msec.
c.
Select the applicable calculation method:
F1 against K FACTOR
F2 against STANDARD
c1 .
FACTOR
Insert the multiplying factor
c2.
STANDARD
Insert Standard concentration value
d.
Select the primary filter pressing F1/F2 and press ENTER to accept
e.
Select the secondary filter pressing F1/F2 and press ENTER to accept
f.
Select the cell temperature pressing F1/F2 and press ENTER to accept
g.
Insert measure unit typing the characters (max 6) and pressing ENTER
h.
Record as memorandum the minimum and maximum expected value
m.
Record as memorandum the sample and reagent volumes
Choice if the blank reagent has to be executed. If yes is selected, insert the
acceptance min and max value..
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 26
4.6. ASSAY MODIFICATION
gg/mm/aa
hh:mm
ASSAY
TIMER
-----------------------
From Main menu press F1 to Select assay .
F1
F2
F1
Press F1 to select assay by number.
Press F2 to select assay from the list.
SELECT ASSAY
number
list
----------------------F1
F2
F2
F1
Press ENTER to select the assay.
va alla prima posizione
libera della lista
ENTER NUMBER:_
(0 for printout)
----------------------F1
F2
N. 1 "NAME"
next
previous
-----------------------
By pressing F2 the assay parameters can be changed.
ENTER
F1
F2
ENTER
N. 1 "NAME"
run
change
----------------------F1
Press F1 a printing of all parameters is possible.
F2
F1
PRINTING PARAM.
yes
no
----------------------F1
F2
F2
F1
PRINTING PARAM.
----------------------F1
F2
F1
NAME=
incr
decr
-----------------------
First of all, the name of the assay may be changed.
Enter assay name with F1 and F2 keys to select digits and/or
letters (10 characters max).
Press SET to accept a letter and to shift to the next one.
Once the assay name has been typed, press ENTER.
F1
F2
ENTER
1: ABS 2: CONC
Then the display will appear to choose for the assay method to
carry out:
−
Press 1 for ABS
−
Press 2 for CONCENTRATION
−
Press 3 for KINETIC
3: KINETIC
1
2
3
ABS
CONC
KINETIC
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Analyzer 90
USER MANUAL
Page 27
4.7. ASSAY PROCESSING
The following flow chart (Table 4.7- ASSAY PROCESSING) shows the procedure needed to process an assay.
Table 4.7 - ASSAY PROCESSING – FLOW CHART
-STARTAssay
Running
Assay
Stored?
yes
Modify
Assay?
yes
no
Assay Setup
no
Assay Modification
Parameter
Printing
Print
Parameter?
yes
no
CONC
ABS
Blank
Reagent
Method
yes
KINETIC
Read
no
CONC
OD Reading
no
KINETIC
Curva
Conc
Accept?
Onecal
KINETIC
OD Printing
yes
Factor
no
Curve
Stored?
Factor
yes
Standard
Conc
no
New Curve
Accept
Curve?
no
Standard
Stored?
yes
yes
Curve Reading
no
USE STORED
CURVE
Accept
Curve?
yes
Samples
Reading
MODIFY/REJECTED CURVE
Modify
Curve?
no
Curve rejected
no
Samples
Printing
yes
Modufy Curve
Samples
Reading
Samples
Reading
Samples
Pinting
Curve no
stored
OD values
only printing
Curve
stored
Samples Printing
(old curve)
yes
USE STORED
STANDARD
Standard
Reading
no
Accept
Standards?
NEW STANDARD
Accetto
Standard?
yes
Samples
Reading
Samples
Printing
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
4.7.1. Assay Start Up
gg/mm/aa
hh:mm
ASSAY
TIMER
-----------------------
From Main menu press F1 to select Assay .
F1
F2
F1
Press F1 to select assay by number.
SELECT ASSAY
number
list
-----------------------
Press F2 to select assay from the list.
F1
va alla prima posizione
libera della lista
ENTER NUMBER:_
(0 for printout)
----------------------F1
By pressing F1 a printing of all parameters is
possible.
F2
F1
Press ENTER to select the assay.
Press F1 to start the process.
F2
F2
N. 1 "NAME"
next
previous
-----------------------
ENTER
F1
F2
ENTER
The instrument is waiting for achieving the
cell selected temperature
N. 1 "NAME"
run
change
-----------------------
By pressing ENTER the waiting is avoided .
F1
The instrument is ready for “blank” reading.
Suck the blank by pressing the Fill push
button on the probe.
F2
F1
PARAMETERS.
print
next
-----------------------
Blank reading.
F1
The OD is calculated whit reference to the
blank and stored.
This OD value remain in the memory also
after instrument switch-on.
F2
F1
PRINTING PARAM.
Once selected the blank reagent reading is
performance and the confront in the set the
min and max values performed. . It this
measure is outside of the acceptable range,
an error occurred is displayed. As it new
reading is to be performed.
WAITING CELL
TEMPERAT. [nnn]
BLANK READING
Press FILL
----------------------F1
F2
FILL
BLANK READING
BLANK (nn) n.nn
accept
repeat
----------------------F1
ABS
F2
CONC
KINETIC
Vedi par. 4.7.2.
Vedi par. 4.7.3.
Vedi par. 4.7.4.
Page 28
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 29
4.7.2. How to carry out an ABS assay
a.
The instrument is ready for “sample” reading.
Suck the sample by pressing the Fill push button on the probe.
b.
Sample printing if previously selected or upon request
c.
Go to the next sample or end the assay.
4.7.3. How to carry out a CONCENTRATION assay
4.7.3.1.
Concentration - ONECAL assay
a.
If a calibrator is not stored, it is requested to insert it for reading(see step b and followings)
If a calibrator is stored, a direct sample reading is done (see step e and followings)
b.
The instrument is ready for “calibrator” reading.
Suck the calibrator by pressing the Fill push button on the probe.
c.
Calibrator reading
d.
Go to the sample reading (step e) or repeat step b.
e.
The instrument is ready for “sample” reading.
Suck the sample by pressing the Fill push button on the probe.
f.
Sample reading
g.
h.
Sample printing if previously selected or upon request
4.7.3.2.
Go to the next sample or end the assay.
Concentration - CURVE assay
a.
If a curve is not stored, it is requested to insert the calibrators and to read them (see step d
and followings).
If a curve is stored, calibrator values are printed.
b.
The relevant curve, upon request, can be plotted.
c.
If the curve is accepted, sample reading take place (see step n and followings).
If the curve is not accepted, it is requested to insert the calibrators for reading (see step d and
followings).
d.
The instrument is ready for “calibrators” reading.
Suck in sequence each calibrator by pressing the Fill push button on the probe.
e.
The read calibrator values are printed.
f.
If those values are considered correct and are accepted, the relevant curve, upon request, can
be plotted; sample reading take place (see step n and followings).
If some calibrator value is not accepted, the relevant calibrator value can be modified
g.
Insert the quantity in number of calibrators to be modified and then the new OD values.
h.
n.
Print the modified curve
The instrument is ready for “sample” reading.
Suck the sample by pressing the Fill push button on the probe.
p.
Sample reading
q.
Sample printing if previously selected or can be done upon request
r.
Go to the next sample or end the assay.
Analyzer 90
USER MANUAL
4.7.3.3.
Concentration - FACTOR assay
a.
The instrument is ready for “sample” reading.
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 30
Suck the sample by pressing the Fill push button on the probe.
b.
Sample reading
c.
d.
Sample printing if previously selected or upon request
Go to the next sample or end the assay.
4.7.4. How to carry out a KINETIC assay
4.7.4.1.
a.
Kinetic - STANDARD assay
If the value of the standard is not stored, it is requested to insert the standard for reading (see
step b and followings)
If the standard is stored, sample reading takes place(see step e and followings).
b.
The instrument is ready for “standard” reading.
Suck the standard by pressing the Fill push button on the probe.
c.
Standard reading
d.
Go to the sample reading (step e) or repeat step b.
e.
The instrument is ready for “sample” reading.
Suck the sample by pressing the Fill push button on the probe.
f.
Sample reading
g.
Sample printing if previously selected or upon request
h.
Go to the next sample or end the assay.
4.7.4.2.
Kinetic - FACTOR assay
a.
The instrument is ready for “sample” reading.
Suck the sample by pressing the Fill push button on the probe.
b.
Sample reading
c.
Sample printing if previously selected or upon request
d.
Go to the next sample or end the assay.
4.8. SERVICE
From the general set up menu the following SERVICE operations are possible, to run functional tests and
to get useful information for service:
INTENSITY TEST
FILTER MOVING
FREQUENCY READING
SET MACHINE
TEMPERATURE TEST
INFORMATION
To measure in percentage the light intensity decrease of the lamp with respect
to the maximum light intensity measured when the lamp was new.
To insert distilled water (blank) in the flow cell it is requested for this test.
To select one specific filter, out of the 7 installed filters, or to select the
“dark” (position 0)
To read the frequency resulting from the conversion of the photodetector
signal into frequency.
To modify internal parameters of the instrument. The access is protected
by password, only qualified personnel is authorized to enter.
To verify the thermostatic regulation of the flow cell; when the temperature
value is achieved, a “bip” is emitted.
To show on the display or to print information data on the instrument, like
serial number, SW revision, type of filters installed, functioning hours, etc.
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 31
4.9. TIMER FUNCTION
The timer function allows to set in a time included in 1 sec to 23hrs, 59min, 59sec a countdown, at the
end of which a beep will be emitted.
gg/mm/aa
hh:mm
ASSAY
TIMER
-----------------------
Access to the TIMER function from the starting
menu by pressing F2.
F1
F2
Pressing F1 you access to the time set up menu
F2
During the countdown the remaining time is shown
hh:mm:ss
set
start
-----------------------
In order to set the time, digit hour, minutes and
then seconds. The settled time will be shown on
screen in square brackets. Press ENTER in order
to confirm the time otherwise digit other values and
then ENTER. The new time settled will be shown
on screen. Press F2 to start the countdown.
Press F1 (stop) to stop the countdown. An acoustic
signal will follow.
F1
F1
F2
hh:mm:ss
HOUR [hh] =
stop
-----------------------
----------------------F1
F2
F1
*
ENTER
MIN.[mm] =
-----------------------
The time set will be keep on memory till a new
program. Press ESC to return to the main menu.
F2
F1
*
SEC [ss] =
----------------------F1
F2
ENTER
F1
*
Nota: Premendo il tasto ESC
si accettano i valori all 'interno
delle parentesi quadre
F2
ENTER
F2
*
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 33
SECTION 5 - MAINTENANCE
Only qualified personnel is entitled to carry out maintenance (see Section 1 of this manual). Carrying out the
maintenance operations, follow the general warnings as described in Section 1 of this manual as well as the
below safety rules.
The operating instrument makes use of chemical reagents and other dangerous (corrosive, irritant and
harmful) CHEMICAL SUBSTANCES which can cause material and personal damages. W hen this label is
found, pay attention to the producer recommendations
The operating instrument handles samples which can be infected (urine and human serum). In this
condition INFECTIONS or CONTAMINATION might occur. Pay attention to the general safety warnings
when in presence of such biological substances. Use protective clothes, gloves and goggles.
5.1. MAINTENANCE AND CHECKS PREVENTIVE MEASURES
The suggested preventive measures are indicated in this chart :
Operation
Period
Cleaning
Daily and/or at the end of each working session.
Functionality Test
OD Test
Linearity Test
once a year suggested
General inspection and checks
Recommended period between checks is three to six months
depending on use.
Under normal use conditions of the instrument, it is recommended of carrying out scheduled servicing as
above indicated, the same it is recommended also before using the instrument after a long period of no
use.
For an intensive use of the instrument we suggest to shorten the periodic maintenance.
5.1.1. Cleaning
Warning: when cleaning do not use alcohol or similar solutions !
While cleaning do not wet the electrical parts (connectors, ecc.) if by accident the electrical
parts do get wet, before using the instrument accurately dry these parts.
After each work session it is recommended to clean well the instrument:
−
follow the decontamination procedure described in Appendix A or other equivalent procedure
−
for the instrument cleaning use a cloth damped with water and light detergent
−
use cloth dampened with detergent solution, avoid using any metal utensils
−
keep clear and clean all the involved work areas of the instrument, remove any dirt or cleaning
substances
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Analyzer 90
USER MANUAL
Page 34
5.1.2. Flow cell cleaning
For Flow cell cleaning, use Extran® MA 01 (MERK) , 20% concentration, or other non-foaming detergent,
as follows:
−
Aspirate washing solution by pressing “FILL” button and fill in the flow cell
−
Leave the solution in the cell for 3 minutes.
−
Empty the flow cell and wash it with distilled water.
ATTENTION!!! Don’t use alcohol or similar
NOTE:
If a visual inspection of the flow cell cleaning status is required, or air bubbles presence has to be verified, it is possible to
extract the flow cell from the instrument. To let the flow cell free, remove the screw from the instrument bottom side
Flow cell access
Flow cell screw
5.1.3. Instrument tests
After each 6 months period it is advisable:
-
to check the optical density (OD) utilizing standard OD values
to test the linearity utilising the standard value and diluting it more times to obtain different
solutions at known values.
5.1.4. Inspection and controls
It is advisable to check periodically all the instrument parts.
-
inspect the supply cable and replace it if damaged;
check the dispensation circuit functioning and if necessary replace the connecting tubings
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 35
5.1.5. Troubleshooting (Diagnosis)
The following table schematically shows some troubles that might occur because of breakdowns, carelessness or
little maintenance, as well as the specific remedy.
TROUBLE
PROBABLE CAUSE
The instrument doesn’t
go on.
The power source is faulty.
Date and hour are not
correct.
The inside battery is flat.
REMEDY
Check the power cord and source.
Check the fuses, if necessary replace them.
Incomprehensible
The start has gone wrong.
messages are displayed.
Call for Technical Assistance.
Switch off the instrument and switch on again
after at least 10 seconds. If the problem
continues, call for Technical Assistance.
PRINT ERROR H is
displayed:
This message indicate an error with Try to remove gently the paper, if the
the printer, due to printer head is not problem persists contact the Technical
able to return in home position (at the Assistance.
left). Maybe paper is locked.
PRINT ERROR 0 is
displayed
This message means that the printer Call for Technical Assistance.
doesn’t work because of electronics
board failure.
MEMORY ERROR is
displayed
It means that some memorized data Call for Technical Assistance
are missing.
FILTER ERROR is
displayed
It means that some memorized filter
value is missing.
Call for Technical Assistance
The instrument doesn’t
dialogue with the PC
Incorrect connection
Check the cable connection, be sure of the
serial port
Check the program setting for the utilized
serial port
The instrument sends to
the PC wrong messages
The instrument transmission is
different from the one of the
communication program
Check the data transmission speed of the
instrument and the one of the program are
the same (9600 baud)
NOTE:
If troubles are caused by the printer, it is automatically excluded and the instrument go on working regularly, supplying the measures only
through the display and the RS232 serial port.
5.2. REPAIRS
Only simple current maintenance is allowed to the user.
In case of breakdowns or defects that might occur to the instrument, qualified technical interventions are required.
REPAIRS (extraordinary maintenance) have to be carried out only (see Section 1) by:
•
SPECIALIZED Technicians with an intimate knowledge of the instrument, which
can be acquired following an appropriate training course; they have to follow the
instrument “service” instructions and use original spare parts.
•
Authorized Technical Service licensed centers, which can operate (on request or
under annual assistance contract), by Specialized Technicians, using original spare
parts.
Transformations or modifications of the instrument are not allowed. The user is liable for any
instrument improper use or modification and for the deriving consequences.
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 37
SECTION 6 - PACKING, TRANSPORTATION AND STORING
6.1. GENERALITY
For the packing, transportation and storing operations it is required to put the instrument “out of service”.
For this it is necessary to follow carefully the instructions contained in Sec. 8 of this manual.
The instrument has been used with samples potentially infected (urine, human sera
etc.) that could have been caused INFECTIOUS CONTAMINATIONS. General safety
warnings about biological substances potentially infected have to be observed.
Before putting the instrument out of service, IT HAS TO BE DECONTAMINATED! (see
APPENDIX A)
Before transportation or storage of the instrument, draw up the DECONTAMINATION
DECLARATION dated and signed by a qualified person.
6.2. PACKING THE INSTRUMENT
Packing of the instrument is required when transportation is involved. To pack the instrument follow the
instructions as below described:
-
Position the instrument inside its original case or in a equivalent safe container.
-
In this case protect the instrument with plastic sheets, fixed with packaging tape.
Apply on the case proper stickers and safety indications:
“OUT OF SERVICE MATERIAL”
Material with potentially infectious substances
6.3. TRANSPORTATION
The transportation of the instrument when unpacked must be limited within the room where it is used,
avoiding damaging bumping.
The instrument can be transported using the original packaging.
During transportation the instrument has to be accompanied by the decontamination
declaration.
6.4. STORING THE INSTRUMENT
Before storing the instrument for a long period, pack it carefully as described above.
For the instrument storage, put it in the original packaging and store it at 80% max of relative humidity and at
o
temperature range of 4 - 60 C
The instrument has to be accompanied by the decontamination declaration (see section 8 of
this manual) possibly stuck on the case.
!
The safety warnings and general rules have to be observed when moving or lifting the instrument.
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 39
SECTION 7 – APPENDIX
APPENDIX A
A.1.
INSTRUMENT DECONTAMINATION.
The instrument involves the handling of samples which can be infected by urine and human sera. In
this condition INFECTIONS or CONTAMINATION might occur.
Every part and accessory of the instrument must be considered potentially infected.
A.1.1.
Decontamination procedure
Use one of the following wide band disinfectant solutions (or equivalent):
¾
Aseptisol
¾
Germocid Plus
¾
Lysetol
Use the solution only for the instrument surface.
¾
Wear disposable gloves, protective glasses and suitable clothes
¾
prepare an autoclave bag for the disposable items used for the decontamination and label the bag with an
autoclave band mark
¾
unplug the instrument in order to avoid explosions
¾
remove all the accessories and disinfect the ones which have to be sent with the instrument
¾
spray the disinfectant solution on the instrument surface or use a cloth or paper soaked in a disinfectant
solution
¾
leave the solution on the instrument for 10 minutes and repeat the treatment from the preceding point
¾
leave the solution on the instrument for 5 hours, clean the instrument surface by a light detergent or water to
eliminate any dirt or disinfectant solution
¾
carefully dry the instrument
¾
put the instrument and its accessories into their original box
¾
wash and disinfect the hands by using a light detergent
¾
Fill in a Decontamination Declaration and enclose it with the instrument
Analyzer 90
USER MANUAL
Doc. N° MDU-AN-09-00-02
Rev.01
Date: 28.05.2007
Page 40
A.1.2. Decontamination declaration
The Decontamination declaration as shown below, has to be filled in and enclosed with the instrument
before shipping it for maintenance service.
The declaration has to be stuck on the instrument package.
DECONTAMINATION DECLARATION
Instrument:_____________________________
Model:________________________________
S/N _________________________
We declare that :
‰
the instrument and its accessories never came in touch with
dangerous biological substances
o
‰
or
the instrument and its accessories have been decontaminated to
eliminate every biological substance which could be dangerous for
personnel.
User/Client name:____________________________________
Company:_______________________________________
Address:___________________________________
Date ___________________
Signature and Stamp __________________