GLOBAL DIAGNOSTICS MICRO TOUCH 1300 User manual
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MICRO TOUCH 1300
F13, User Manual , V3 09.08.2020
Biochemistry Analyser
MICRO TOUCH 1300
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MICRO TOUCH 1300
F13, User Manual , V3 09.08.2020
TABLE OF CONTENTS
1. GENERAL INFORMATION.......................................................................................................5
1.1. WARRANTY INFORMATION.............................................................................................................................5
1.2. TECHNICAL SERVICE.........................................................................................................................................5
1.3. DISPOSAL INSTRUCTION ..................................................................................................................................6
1.4. CONTACTS............................................................................................................................................................6
2. GENERAL SAFETY WARNINGS..............................................................................................7
2.1. DANGER –WARNINGS SYMBOLS...................................................................................................................7
2.2. USE OF THE INSTRUMENT................................................................................................................................9
3. INTRODUCTION........................................................................................................................11
3.1. DESCRIPTION....................................................................................................................................................11
3.2. FEATURES..........................................................................................................................................................12
3.3. TECHNICAL SPECIFICATION OF MICRO TOUCH 1300 ……………………………………….13
4. PACKING, TRANSPORT AND STORAGE............................................................................15
4.1. GENERAL WARNINGS ....................................................................................................................................15
4.2. PACKING ............................................................................................................................................................15
4.3. INSTRUMENT TRANSPORTATION................................................................................................................15
4.4. STORAGE OF INSTRUMENT...........................................................................................................................15
5. INSTRUMENT DESCRIPTION................................................................................................16
5.1. TOUCH SENSITIVE SCREEN...........................................................................................................................16
5.2. PERSPECTIVE VIEW ........................................................................................................................................18
5.3. KEYPAD..............................................................................................................................................................20
5.4. PROBE.................................................................................................................................................................21
5.5. PERISTALTIC PUMP .........................................................................................................................................21
5.6. INSTRUMENT WORKING PRINCIPLE............................................................................................................21
5.7. PRINTER .............................................................................................................................................................24
6. INSTALLATION AND START-UP INSTRUCTIONS...........................................................24
6.1. PLACING THE INSTRUMENT .........................................................................................................................24
6.2. POWER SUPPLY ................................................................................................................................................24
6.3. PROTECTIVE GROUNDING ............................................................................................................................24
6.4. START UP INSTRUCTIONS..............................................................................................................................25
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7. PRECAUTIONS ..........................................................................................................................27
8. MAIN MENU...............................................................................................................................28
8.1. PROGRAMMING/ADDING A NEW TEST....................................................................................................................... 28
8.2. TECHNICAL DIAGNOSIS.................................................................................................................................34
8.2.1. CLEAR MEMORY.........................................................................................................................................34
8.2.2. SELECT FILTER............................................................................................................................................35
8.2.3. HOME FILTER WHEEL...............................................................................................................................35
8.2.4. LAMP AMPLITUDE.......................................................................................................................................36
8.2.5. TEMPERATURE SETTING ...........................................................................................................................37
8.2.6. PRINTER SELF TEST...................................................................................................................................38
8.3. UTILITIES SCREEN...........................................................................................................................................................39
8.3.1. TO ENTER/ CHANGE DATEAND TIME..................................................................................................39
8.3.2. PASSWORD UTILITY ..................................................................................................................................40
8.3.3. WASH F.C...........................................................................................................................43
8.3.4. MODE.............................................................................................................................................................44
8.3.5. PUMP CAL.....................................................................................................................................................45
8.3.6. PROGRAM FILTER.......................................................................................................................................48
8.3.7. TO DISABLE /ENABLE PRINTER ............................................................................................................49
8.3.8. TO ENTER CLINIC /DOCTOR NAME......................................................................................................50
8.3.9. LAMP: ON...........................................................................................................................51
8.3.10. COMMUNICATION: SERIAL ...................................................................................................................51
8.3.11. PRIORITIES TEST......................................................................................................................................52
8.3.12. DISTRIBUTOR NAME...............................................................................................................................55
8.4. QUALITY CONTROL........................................................................................................................................56
8.5. VIEW STORED RESULTS/ PRINT PATIENT REPORT...............................................................................59
8.6. COMMUNICATION ...........................................................................................................................................60
9. PROGRAMMING MODES........................................................................................................65
A] USER DEFINEDPROGRAMMING MODES.................................................................................................................. 65
9.1. ABSORBANCE ...................................................................................................................................................65
9.2. FIXED TIME.......................................................................................................................................................67
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9.3. KINETIC ................................................................................................................................69
9.4. END POINT ...........................................................................................................................71
9.5. DIFFERENTIAL..................................................................................................................................................75
9.6. RATIO..................................................................................................................................................................77
10. QC run in Biochemistry mode.................................................................................................79
11. Coagulation................................................................................................................................82
12. RFID...........................................................................................................................................85
13. GENERAL FUNCTIONS ........................................................................................................87
13.1. ENTER TEST NAME......................................................................................................................................87
13.2. TEMPERATURE SELECTION.......................................................................................................................88
13.3. FILTER SELECTION.......................................................................................................................................89
13.4. SELECTION OF UNITS..................................................................................................................................90
13.5. BLANK SELECTION......................................................................................................................................91
13.6. SELECTION OF ASPIRATION/SIPPING VOLUME....................................................................................92
13.7. NORMAL VALUE SELECTION....................................................................................................................93
13.8. LAG TIME........................................................................................................................................................94
13.9. READ TIME.....................................................................................................................................................95
13.10. LIMIT SET (END POINT, DIFFERENTIAL& RATIO).............................................................96
13.11. FACTOR / K-FACTOR /STANDARD SELECTION ................................................................................97
13.12. QCVALUES...............................................................................................................................................100
14. TROUBLE SHOOTING ........................................................................................................101
15. DECONTAMINATION .........................................................................................................102
15.1. DECONTAMINATION PROCEDURE.........................................................................................................102
15.2. PURPOSE OF DECONTAMINATION.........................................................................................................102
15.3. GENERAL CONSIDERATIONS...................................................................................................................102
15.4. PROCEDURE .................................................................................................................................................103
16. SAFETY CLEARANCE CERTIFICATE...........................................................................104
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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.
GLOBAL DIAGOSTICS B 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:
GLOBAL DIAGOSTICS B 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.
GLOBAL DIAGOSTICS B 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.
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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 forinstrument disposal.
•Plastic parts, Electronic PCBs and components can be recycled, so returnback the
instrument to manufacturer.
1.4. Contacts:
Manufacturer:
Manufacturer:
Global Diagnostics B,
Sijsjesstraat 4, 2440 Geel
Belgium.
info@globaldiagnosticsb.com
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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 orerroneous
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.
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General Symbols
Symbol for “Manufacturer”
Symbol for “ IN VITRO DIAGNOSTIC MEDICAL DEVICE”
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2.2.Use of the Instrument:
•The instrument has to be used for the designed purposes under specified conditions, following proper
procedures and safety rules, by qualifiedpersonnel.
THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL
•A 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 theinstrument).
•A 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.
•The instrument has to be used as described in this manual. If it is not use the protection provided by
the instrument may be impaired.
•Alterations to the instrument are prohibited. The user is liable for any improper modification to the
instrument, and for the derivingconsequences.
•Should 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.
•This IVD equipment complies with the emission and immunity requirements as per IEC61326 series.
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•Warning: 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
theinterference."
•An advisory that the electromagnetic environment should be evaluated prior to operation of the device.
•Warning: 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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3. INTRODUCTION
3.1.DESCRIPTION:
MICRO TOUCH 1300 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.
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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 backup for 250 Biochem tests, 25 Coag & 25 RFID test with 30
results saved in each 3 levels ofQC
•Capacity of saving 2500 test 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.
•Levy Jennings and standard deviation graphs.
•Optional interface for External Printer.
•Patient report with PID & Name.
•Access to Test by Touch of Key.
•Resolution of saving 4 decimal points.
•User defined temperature 20°C to 40°C
•On-line Graph in Fixtime and Kinetic mode.
•Online data output for LIS communication through RS232 Serialport.
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3.3.Technical specification of MICRO TOUCH 1300 :
Human Machine Interface
:
TOUCHPANEL / KEYPAD
Linear measurement range
:
0.0000 to 3.0000 Absorbance Units (A)
Photometric Accuracy
:
± 2% or 0.007 whichever is higher, from 0 to 1.5A
± 3% from 1.5A to 3.0A
Drift
:
< 0.007 A/hr
Photometric Linearity
:
2.2 A
Optical measurement
:
Photodiode
Filters:
Type of Filter
Wave Length Half
Bandwidth
:
:
:
Interference
340, 405, 510, 545, 578, 630 and two optional 10nm ± 2nm
Flow Cell : Sipping
Volume Flowcell
Volume Sipping
Mode
:
:
:
500 to 1000µl
18µl
Automatic by specially designed Peristaltic pump.
Cuvette Volume
:
500µl
Dry Block Incubator: Number of
Cuvette
Temperature
:
:
15 Test Tubes
37° C
Temperature of Cuvette/
Flowcell:
Method
Temperature
User Defined Temperature
:
:
By Peltier effect 25,
30 and 37° C
20° C to 40° C
Light Source
:
Tungsten Halogen
Warm Up Time
:
90 sec
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Display
:
5” Color TFT LCD module
Printer
:
Built in Thermal Printer
Memory
:
512KB FRAM
Storage Capacity
250 biochem, 25 coag & 25 RFID Open Tests with 30 QC
results for each levels
and 2500 Patient results with patient ID (6 digits)
Analysis Mode
User Defined Modes
:
Absorbance Kinetic
End Point Differential
Ratio Fixed Time
Coagulation
Pre Defined Modes
:
Concentration Calculations
:
By Factor or by Standard
RS232 serial port
:
115200 baud, 1start, 8 data, 1 stop, no parity bits
Power
Wattage
:
100VA
Voltage
:
115 - 230 Volts ± 10%, 60 –50 Hz
Operating Position
:
On Horizontal, flat, rigid, and vibration free surface
Operating Conditions Temperature
Relative Humidity
:
:
From ± 18° C to ± 35° C Upto
85%
Storage Conditions
Temperature Relative
Humidity
:
:
From -10° C to + 60° C Upto
85%
Enclosure
:
ABS Fire retardant
Size (cm)
:
30 x 38 x 13.5 (l x b x h)
Weight
:
5.5 Kg (Approx.)
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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 instrumentinto 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 avoiddamage.
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 -10ºC and
+60ºC.
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5. INSTRUMENT DESCRIPTION
5.1.Touch Sensitive screen:
MICRO TOUCH 1300 provides a Touch sensitive TFT 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 END POINT 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.
For Example: - To activate the selection.
•To enter the primary filter value, touch any point in the shaded area “FIL-P” on the TFT LCD screen.
On proper selection the analyser responds with selected value display on numeric keypad with the help
of enter touchzone.
•To enter Test Name: Touching the “NAME” touch zone provides an alphanumeric screen. Enter the
Test name by touching the Touch zone of that variable. The selected value blinks and is displayed
next to theparameter.
NAME
FIL-P
340
FIL-S
000
UNIT
No_Unit
MODE
EP
LAG
5
VOL
500
TEMP
37
BLANK
N
READ
STD
N
LIMIT
QC
N
NOR
N
FACT
1.0000
KF
1.0000
ESC
SAVE
ADD
PRN
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5.2.Perspective View
Front View:
Incubator
Flow cell
Touch Screen
Printer
LID
Keypad
Aspiration
Switch
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Rear View:
Cooling Fan
ON / OFF Switch
RS 232
Socket
Waste Outlet
Peristaltic Pump
Module USB SMPS
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5.3. KEYPAD
The FEED key is used to advance the printer paper by 1 line.
PRINT key is used to take the print.
WASH key is provided for aspiration of liquid into the Flowcell and for washing flow cell.
YES key is display / program specific
NO key is display / program specific
ESC key is used for escaping
These are navigation keys for direct selections of tests.
ENTER Key
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5.4 Probe:
The instrument is provided with a probe to aspirate the sample into the flow cell. The push button
(Aspiration Switch) has to be pressed to activate the peristaltic pump.
5.5 Peristaltic pump:
The instrument is provided with a peristaltic suction pump. The aspiration push button switch activates the
peristaltic pump. The pump is enabled during wash and during “Aspirate sample”message
5.6 Instrument working principle:
Instrument functional sequence:
5.6.1 Switch on the instrument
5.6.2 Program the test.
5.6.3 Aspirate the sample into the flow cell
5.6.4 The measures and the calculations are carried out according to the
assay method
Table of contents
