ROBONIK prietest TOUCH User manual

prietest TOUCH USER MANUAL
Version No.: 2.622A
Effective Date:Nov, 2011Page 1of 52
prietest TOUCH
Biochemistry Analyser
USER MANUAL
ROBONIK (INDIA) PVT. LTD.
Plot No.: A-374, TTC, MIDC Industrial Area,
Mahape, Navi Mumbai –400 710. (INDIA)
Tel.: +91 (22) –67829700, Fax : +91 (22) –67829701
[e-mail]
Website-www.robonik.in
User Manual Version
With Incubator 2.622A

prietest TOUCH USER MANUAL
Version No.: 2.622A
Effective Date:Nov, 2011Page 2of 52
TABLE OF CONTENTS
1. GENERAL INFORMATION........................................................................................................3
1.1.WARRANTY INFORMATION:................................................................................................3
1.2.TECHNICAL SERVICE:........................................................................................................3
1.3.DISPOSAL INSTRUCTION:...................................................................................................3
1.4.CONTACTS:........................................................................................................................3
2. GENERAL SAFETY WARNINGS.............................................................................................3
2.1.DANGER –WARNINGS SYMBOLS:......................................................................................3
2.2.USE OF THE INSTRUMENT:.................................................................................................3
3. INTRODUCTION..........................................................................................................................3
3.1 DESCRIPTION:................................................................................................................3
3.2.FEATURES:.....................................................................................................................3
3.3.TECHNICAL SPECIFICATION OF PRIETEST TOUCH...........................................................3
4. PACKING, TRANSPORT, AND STORAGE ...........................................................................3
4.1.GENERAL WARNINGS:................................................................................................3
4.2.PACKING:........................................................................................................................3
4.3. INSTRUMENTTRANSPORTATION ...........................................................................3
4.4.STORAGE OF INSTRUMENT......................................................................................3
5. INSTRUMENT DESCRIPTION..................................................................................................3
5.1.TOUCH SENSITIVE SCREEN...............................................................................................3
5.2.PERSPECTIVE VIEW...........................................................................................................3
5.3.KEYPAD...........................................................................................................................3
5.4.PROBE................................................................................................................................3
5.5.PERISTALTIC PUMP............................................................................................................3
5.6. INSTRUMENT WORKING PRINCIPLE ....................................................................................3
5.7.PRINTER.............................................................................................................................3
6. INSTALLATION AND START-UP INSTRUCTIONS:............................................................3
6.1.PLACING THE INSTRUMENT................................................................................................3
6.2.POWER SUPPLY .................................................................................................................3
6.3.PROTECTIVE GROUNDING .................................................................................................3
6.4.START UP INSTRUCTIONS ..................................................................................................3
7. PRECAUTIONS............................................................................................................................3
8. MAIN MENU..................................................................................................................................3
8.1.TESTOPERATIONS......................................................................................................3
A)PROGRAMMING/ADDING A NEW TEST............................................................................3
B)RECALLING /RUNNING A SAVED TEST(OPERATING THE PROGRAMMED TESTS).............3
C)LIST TESTS:..........................................................................................................................3
8.2.TECHNICAL DIAGNOSIS:............................................................................................3
8.2.1. Clear Memory ......................................................................................................................................................3
8.2.2. Home Filter wheel...............................................................................................................................................3
8.2.3. Select Filter...........................................................................................................................................................3
8.2.4. Temperature Setting............................................................................................................................................3
8.2.5. Lamp Amplitude...................................................................................................................................................3
8.2.6. Printer Self Test ...................................................................................................................................................3

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Effective Date: July, 2010 Page 3of 52
8.3.UTILITIES SCREEN.......................................................................................................3
8.3.1. To ENTER/CHANGE Date and Time...............................................................................................................3
8.3.2. Password Utility...................................................................................................................................................3
8.3.3 WASH F.C ..............................................................................................................................................................3
8.3.4 Mode:......................................................................................................................................................................3
8.3.5 Pump Cal:..............................................................................................................................................................3
8.3.6 Program Filter......................................................................................................................................................3
8.3.7. To disable or enable the Printer.......................................................................................................................3
8.3.8 To Enter Clinic / Doctor Name:.........................................................................................................................3
8.3.9 Lamp: ON...............................................................................................................................................................3
8.4.QUALITYCONTROL......................................................................................................3
8.5.VIEW STORED RESULTS/PRINT PATIENT REPORT. .........................................................3
8.6.COMMUNICATION:..............................................................................................................3
9. PROGRAMMING MODES.........................................................................................................3
9.1.ABSORBANCE................................................................................................................3
9.2.FIXED TIME .....................................................................................................................3
9.3.KINETIC............................................................................................................................3
9.4.END POINT......................................................................................................................3
9.5.DIFFERENTIAL...............................................................................................................3
9.6.RATIO...............................................................................................................................3
9.7.COAGULATION..............................................................................................................3
10. GENERAL FUNCTIONS...........................................................................................................3
10.1.ENTER TEST NAME..........................................................................................................3
10.2.TEMPERATURE SELECTION..............................................................................................3
10.3.FILTER SELECTION...........................................................................................................3
10.4.SELECTION OF UNITS ......................................................................................................3
10.5.BLANK SELECTION...........................................................................................................3
10.6.SELECTION OF ASPIRATION/SIPPING VOLUME................................................................3
10.7.NORMAL VALUE SELECTION ............................................................................................3
10.8.LAG TIME..........................................................................................................................3
10.9.READ TIME.......................................................................................................................3
10.10.LIMIT SET (END POINT,DIFFERENTIAL &RATIO)..........................................................3
10.11.FACTOR /K-FACTOR /STANDARD SELECTION .............................................................3
11. TROUBLE SHOOTING:...........................................................................................................3
12. DECONTAMINATION..............................................................................................................3
12.1.DECONTAMINATION PROCEDURE....................................................................................3
12.2.PURPOSE OF DECONTAMINATION ...................................................................................3
12.3.GENERAL CONSIDERATIONS ...........................................................................................3
12.4.PROCEDURE ....................................................................................................................3
13. SAFETY CLEARANCE CERTIFICATE............................................................................... 3

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Version No.: 2.622A
Effective Date: July, 2010 Page 4of 52
1. GENERAL INFORMATION
1.1. Warranty Information:
Each Instrument is completely tested and guaranteed for twelve months from delivery. The warranty
applies to all the mechanical and electrical parts. It is valid only for proper installation, use, and
maintenance in compliance with the instructions given in this manual.
ROBONIK will at its discretion repair or replace parts, which may be found defective in the warranty
period. The warranty does not include any responsibility for direct or indirect personal and material
damages, caused by improper use or maintenance of the instrument.
Parts that are inherently subject to deterioration are excluded from the warranty. In case of defects
due to misuse of the instrument, any travel and man-hour expenses will be charged extra.
1.2. Technical Service:
ROBONIK is always accessible to the customers for any kind of information about installation, use,
maintenance, etc. When asking for service, please refer to this manual, and report the data reported
on the identification label (serial number).
Only qualified technicians are entitled to fix the instrument; the user, as described in this manual,
should carry out ordinary maintenance.
ROBONIK technical service or an authorized service center with specialized technicians, with suitable
instrumentation and original spare parts only are always available for extraordinary maintenance
(repair), under a yearly maintenance contract or on specific demand.
1.3. Disposal Instruction:
In case of removal or disposal of instrument, following instructions need to be followed
•Do not dispose in municipal waste; follow local regulations for instrument disposal.
•Plastic parts, Electronic PCBs and components can be recycled, so return back the instrument to
manufacturer.
1.4. Contacts:
Manufacturer:
ROBONIK (INDIA) PVT LTD
A-374, TTC, MIDC Industrial Area,
MAHAPE, NAVI MUMBAI –400710
INDIA
Tel: [phone],
Fax: [phone]
Email: [email protected]
Website: www.robonik.in
European Authorized Representative
Obelis s.a
34, Av. de Tervuren, bte 44
B-1040 Brussels, BELGIUM
Tel: [phone]
Fax: [phone]
E-Mail : [email protected]

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Effective Date: July, 2010 Page 5of 52
2. GENERAL SAFETY WARNINGS
2.1. Danger –warnings symbols:
The following symbols are used to inform the user of the safety rules.
This symbol indicates generic danger. It means that, serious damage can occur to the
operator if described precautions are not observed.
This symbol indicates HIGH ELECTRIC VOLTAGE. It is dangerous to touch any part
having this label. Only qualified operators can access these components, after unplugging
the instrument from the Supply.
This symbol indicates that the instrument involves the handling of samples, which can be
infected (urine or human serum). In this condition, infection or contamination might occur.
Pay attention to the general safety warnings when in presence of such biological
substances. Use Protective clothes, gloves and glasses.
This symbol in the user manual indicates that damages to the instrument or erroneous
results could occur if the given warnings are not followed.
This symbol indicates a portion, which is particularly important, and should be studied
carefully.
This symbol indicates a Protective Earth or Ground terminal.
General Symbols
Symbol for “Manufacturer”
Symbol for “ IN VITRO DIAGNOSTIC MEDICAL DEVICE”
Symbol for “AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY”

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Version No.: 2.622A
Effective Date: July, 2010 Page 6of 52
2.2. Use of the instrument:
ØThe instrument has to be used for the designed purposes under specified
conditions, following proper procedures and safety rules, by qualified personnel.
ØTHIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL.
ØA qualified user has to make sure that environmental condition is suitable, the
installation is correct, the use and maintenance are proper, according to the general
safety rules as well as to the particular precautions described in the manual.
(However, he is not entitled to repair the instrument).
ØA qualified technician is entitled to maintain and fix the instrument, according to the
instructions given, using the original spare parts. Maintain room temperature and
Humidity as specified in the manual.
ØThe instrument has to be used as described in this manual. If it is not use the
protection provided by the instrument may be impaired.
ØAlterations to the instrument are prohibited. The user is liable for any improper
modification to the instrument, and for the deriving consequences.
ØShould the instrument need extraordinary maintenance, contact MANUFACTURER
service or authorized service center. Specialized technicians who will be able to
repair the instrument using original spare parts will carry out the maintenance.
ØThis IVD equipment complies with the emission and immunity requirements as per
IEC61326 series.
ØWarning : This equipment has been designed and tested to CISPER11 Class A. In
a domestic environment it may cause radio interference, in which case, you may
need to take measures to mitigate the interference."
ØAn advisory that the electromagnetic environment should be evaluated prior to
operation of the device.
ØWarning :Do not use this device in close proximity to sources of strong
electromagnetic radiation (e.g. unshielded international RF sources), as these may
interfere with the proper operation.

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Effective Date: July, 2010 Page 7of 52
3. INTRODUCTION
3.1 DESCRIPTION:
prietest TOUCH is a programmable Biochemistry Analyzer with a user-friendly
touch screen. It measures the optical densities of samples and it uses algorithm to
calculate results, which are used for biochemical investigation. It 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 a user-friendly program and capacity of storing the programmed
analytical methods and the QC results. It is intended for in vitro diagnostic use.
3.2. FEATURES:
—Effective temperature regulation system with Peltier controlled cuvette / flow cell
block.
—Dual reading mode
—Robust system with built in stabilizer.
—Latest technology with battery back up for 250 tests with QC, more than 2000
results.
—Robust in built 20 Column Thermal Printer with 384 stationary heads.
—Unique circuitry for long lamp life.
—Reliable peristaltic pump with maintenance free operations.
—Sophisticated software for kinetic graph with built in delta calculation for saturated
(high) samples from graphic display without diluting and rerunning the samples.
—Monochromatic, Bichromatic Measurement
—Multi Standard Calibration
—Patients ID entry.
—Editing of saved tests.
—Human machine user interface:
Touchpad, Keypad
—Built in Incubator
—Levey Jennings and standard deviation graphs.
—Optional interface for External Printer
—Patient report with PID & Name
—Access to Test by Touch of Key

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Effective Date: July, 2010 Page 8of 52
3.3. Technical specification of prietest TOUCH
Human Machine Interface TOUCH PANEL / KEYPAD
Linear measurement range 0.000 to 3.000 Absorbance Units (A).
Photometric Accuracy ± 2% or 0.007 whichever is higher, from 0 to 1.5 A
± 3% from 1.5 A to 3.0 A
Drift <0.007 A/hr
Photometric Linearity 2.2 A
Optical measurement Photodiode
Filters Type of filter
Wave Length
Half Bandwidth
Filter Selection
Interference
340, 405, 510, 546, 578 and 630 nm & Two Optional
10nm ± 2nm
Automatic by Stepper Motor.
Flow Cell
Sipping Volume
Flow cell Volume
Sipping Mode
300 to 1000 µl
18µl
Automatic by specially designed Peristaltic Pump
Cuvette Volume 500 µl
Dry Block Incubator
Number of cuvettes
Temperature
15 Test Tubes
370C
Temperature of cuvette/flow cell Block
Method
Temperature
By Peltier effect
25, 30 and 370C
Lightsource Tungsten Halogen
Warm up Time 90 Sec
Display 5” Graphic LCD, Negative Blue, STN
Printer Built in thermal printer
Memory 64 KB –Non volatile RAM with Batteryback up
Storage Capacity 250 Open tests, with 30 QC results / test
(Normal and abnormal controls) and more than
2500 Patient results with patient ID (6 digits)
Analysis Mode Absorbance Kinetic
End Point Differential
Ratio Fixed Time
Coagulation
Concentration Calculation By factor or by Standard
RS232serialport 9600 baud, 1 start, 8 data, 1 stop, no parity bits
Power Wattage
Voltage
50 watts
115 –230 Volts ± 10 %, 60–50 Hz
Operating Position On horizontal, flat, rigid and vibration free surface
Operating Conditions
Temperature
Relative Humidity
From + 180C to + 350C
Up to 85 %
Storage Condition
Temperature
Relative Humidity
From –100C to + 600C
Up to 85 %
Enclosure ABS Fire retardant
Size (cm) 30 X 38 X 13.5 (l X b X h)
Weight 5.5 Kgs. (Approx)

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Effective Date: July, 2010 Page 9of 52
4. PACKING, TRANSPORT, AND STORAGE
4.1. GENERAL WARNINGS:
Instrument has to be decontaminated before packing for transportation.
4.2. PACKING:
Packaging is needed whenever the instrument is to be transported or shipped by
courier or other means.
To pack the instrument follows the instructions below:
—Decontaminate the instrument as explained on decontamination chapter of this
manual.
—Put the instrument into the original packaging box; Instrument has to be properly
protected by plastic protective material. Put copy of safety clearance certificate
(copy of Safety clearance certificate is attached at the end of this manual).
—Mark the package with address, instrument identification and warninglabels.
4.3. INSTRUMENT TRANSPORTATION
The transportation of the instrument in unpacked condition must be limited within the
room where it is used, to avoid damage.
4.4. STORAGE OF INSTRUMENT
Before storing the instrument for a long period, pack it carefully as described above
and store indoors.
Relative humidity has to be less than 85%, and temperature between -10ºCand
-60ºC.

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Effective Date: July, 2010 Page 10 of 52
5. INSTRUMENT DESCRIPTION
5.1. Touch Sensitive screen
prietest TOUCH provides a Touch sensitive LCD panel and a KEYPAD for easy user
interface. The Menus are displayed; the text of the parameter forms the TOUCH ZONE.
Touch screen Layout
For Example: In Kinetic Mode.
Above is the generic representation of a Test Screen. The Highlighted zones are TOUCH
ZONES, which are active. On touching the “Touch Zone” of a parameter, a sub menu/menu is
displayed or the requested action is carried out, and rest of the “Touch Zone” is deactivated.
For Example: -To activate the selection.
•To enter the primary filter value, touch any point in the shaded area “Pri” on the LCD
screen. On proper selection the analyser responds with blinking of the parameter text and
also the TOUCH ZONE and a submenu is displayed.
•To enter Test Name: Touching the “Name” touch zone provides a alphanumeric screen.
Enter the Test name by touching the Touch zone of that variable. The selected value blinks
and is displayed next to the parameter.
Selection Indicator
Selected onscreen item is shown in a shaded background. When the screen first displays, the
default selection is shown. Pressing a selection either highlights that item or activates it.
Name
:
,
Mod:
KIN
37.29
Pri. : 340 ,Sec.: 0 ESC
ESC
Temp:37C ,KF : 1.000
Vol :300ul , Unit: No –Unt ADD
Lag: 0, Read: 0 NR:
Blk :N, QC: N , Norm: N SAVE
STD: N, Factor:0.000
Limit Set: PRINT