Super+ Manual PDF
Super+ Manual PDF
02
CONTENTS
Chapter2 Installation 11
2.1 Technical specification 12
2.2 Hardware 13
2.3 Hardware Installation 18
2.4 Software installation 20
2.5 Cassette Installation 35
Chapter3 Operation 38
3.1 Quick manual 39
3.2 Routine operation 40
Chapter4 Maintenance 51
4.1 Periodic Maintenance 52
4.2 Maintenance menu 53
Chapter6 Appendix 59
6.1 Communication 60
6.2 Initial value of Range table in each parameter 62
6.3 Program for the sensitivity of each parameter 64
6.4 Measurement density 66
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1.1 Preface
URiSCAN Super+ is a fully automated urine chemistry analyzer, which is designed for
reading urine test strips placed in URISCAN Super+ cassette.
URiSCAN Super+ is optimized for workloads of between 100 and 1000 urine samples per
day. The analyzer is for professional use so that only trained personnel working in a
professional laboratory environment can operate the analyzer. Also, the analyzer is
designed to assay urine samples only.
It is important to read this manual thoroughly before operating URiSCAN Super+. Any
disregard of the instructions in the operator’s manual may result in a safety risk.
Chapter 3 – Operation : This section defines the quick operation and routine
operation process of URISCAN Super+ analyzer in a step-by-step guide.
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1.2 PRECAUTION
The URiSCAN Super+ is guaranteed by YD Diagnostics Corp., for a period of 1(one) year
after the date of purchase against defects due to faulty workmanship or materials. The
guarantee covers both piece parts and labor. Service under guarantee is only provided
upon presentation of reasonable evidence (completed guarantee card or purchase receipt)
that date of the claim is within the guarantee period.
The warranty is not valid if the defect is due to accidental damage, misuse or neglect and
in case of alternations or repair carried out by unauthorized persons. Service (during and
after guarantee) is available in all countries where the URiSCAN Super+ is officially
distributed by YD Diagnostics Corp., the local YD service organizations also arrange
service although there may be a delay if the required spare parts are not readily available.
(1) Customer shall not attempt installation of this instrument to other place after
its delivery. Technical service engineer is needed to install the instrument
for its safe and precise operation.
(2) Before installation of this instrument, the customer shall make reparations
for satisfying the installation requirements in accordance with this manual.
(3) When relocation of this instrument is required, please notify the sales
representative or dealer.
Users can take a technical seminar or training for using this instrument safely
and exactly. For seminar/training procedure, contact sales representative or
dealer.
(1) Strips and quality control samples shall be handled, stored and discarded
according to the instructions given by the respective dealers.
(2) Samples and quality control samples to be used by the customer in analytical
tasks with this instrument shall be handled, stored and discarded by the
customer’s responsibility in accordance with the predetermined laboratory
standards.
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The 400 test strips are placed in the URiSCAN Super+. The test strips are moved
to the pipette area automatically through the mechanical arrangement. One test
strip is used for analyzing each sample. The test results are measured through the
principles of the CCD color image sensor and the equivalent clinical values
obtained.
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CCD is the most advanced optical element that can analysis 3 primary color of light
and read accurate value of the color development of the strip. It can get more
accurate and objective result compare with light and shade detection by photo
diode which used generally.
Analog-to Digital
CCD Image Sensor Converter
LED
CPU
Test Strip
The results that are stored in the memory can be sent to host PC by
RS232C or Ethernet or sent to USB. The results can be printed on the
external printer via parallel port. In additional, the instrument can be
connected to an external keyboard or mouse by PS/2/USB port.
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1.4.1. Overview
URiSCAN Super+ is an analyzer which can test the urine components such as
Blood, Bilirubin, Creatinine, Urobilinogen, Ketones, Protein, Microalbumin, Nitrite,
Glucose, pH, Leucocytes, Ascorbic Acid, color, turbidity and specific gravity(with 13
parameter strip), showing the result values via screen and printing. With 11
parameter strip, it tests Blood, Bilirubin, Urobilinogen, Ketones, Protein, , Nitrite,
Glucose, pH, Leucocytes, Ascorbic Acid, color, turbidity and specific gravity.
The visual evaluation of the color and clarity of the urine sample
Chemical evaluation by using urinalysis strips
Sediment evaluation by using microscopic examination
Out of above, the test method of urinalysis strips is widely used as a test method
for accurate and rapid diagnosis comparatively of each substance’s level of urine
specimens and clinical aspects.
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Communication Interface
Ethernet – direct connection to network
USB – external memory drive, etc
Parallel Communication - external printer
Serial Communication – host computer
PS/2 – barcode reader, keyboard, mouse, etc
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1.6 Caution
1) The instrument must be installed and used in the environment where meets the
following conditions:
Free from excessive dust
Well-ventilated area
Not exposed to direct sunlight
Flat and secured place
Sturdy floor bearing the weight of this product(68Kg,149.91lb)
Ambient temperature is ranging from 15 to 30°C (59-86°F), with a variation of
±2°C (±3°F) during measurement.
Relative humidity should be ranging from 20% to 80%, without moisture
condensation.
Free from sensible vibrations
Use the power cable supplied together which length is about 3m(9,8ft)
Place apart from a machine using high voltage
Free from electromagnetic wave interference
Free from abrupt power fluctuation (rated voltage ±10V max)
Place apart from a machine generating a high frequency (centrifuge, electric
discharge machine, etc.)
Space requirement
① Rear: longer than 20cm (7.9 inches)
② Left: longer than 50cm(19.7inches)
③ Right: longer than 50cm(19.7inches)
2) Power Supply
Operating instruction for AC 100-240V
1. Before using the device, please check if the local operating voltage complies
with AC 100-240V.
2. Plug the power connecting cable into the power input socket of the instrument
and connect the other end with power source.
*It is recommended to use the power cable supplied together. The power switch
and power supply socket are located in the right side.
3) Water Supply
The fresh distilled water should be stored in the water supply tank and used and its
conductivity is 1µS/cm or less.
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1.7 Symbols
Symbol Description
CE Mark
BATCH CODE
SERIAL NUMBER
CATALOGUE NUMBER
BIOLOGICAL RISKS
MANUFACTURER
DATE OF MANUFACTRUE
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Chapter 2 Installation
2.1 Technical specification --------------------------------------------------- 12
2.2 Hardware ------------------------------------------------------------------- 13
2.3 Hardware installation ----------------------------------------------------- 18
2.4 Software installation ------------------------------------------------------ 20
2.5 Install the strip cassette ------------------------------------------------- 35
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2.2 Hardware
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2.2.2.1 Exterior
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Cross View
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*Water supply tank supplies distilled water into the Super+. The maximum volume to store
is up to 20 liter of D.W. which is sufficient to perform up to 1,000 tests.
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The instrument must be installed where flat and free from the
electromagnetic wave interference and vibrations. The floor should be
cleaned without excessive dust, bearing the weight of this product. please
do not attempt the shock while transporting. It is important to keep this
analyzer clean and ventilated. Please install the analyzer apart from high
frequency and electromagnetic wave interference where is free from abrupt
power fluctuation. It is recommended to pull out the power plug after use.
The liquid waste tank is located outside the analyzer. The capacity of the
tank depends on the specific tank which is used. The tank must have
volume of at least 20 L (21 qts). The overflow sensor is available as an
option. 5 meter (16.4 ft) liquid waste tube is supplied for the connection of
the liquid waste tank to the analyzer.
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1) Display
Next Routine Serial# : the routine test sequence number starts from 0001 to
9999. It is automatically increased by the number of routine test.
Next Rack Serial# : the rack sequence number is shown from 01 to 99. It is
automatically increased by the number of rack loaded for testing. It is
automatically reset the number by pressing [Start] button on the [Main] screen.
Next Tube Position Serial# : this indicates the position number of tube in the
rack. The maximum of 10 tubes (positions) can be loaded so that it indicates
from 1 to 10.
2) Result Table
The test result is shown with the image output of tested strip. Test parameters,
real picture of developed color, result and raw data (maintenance mode) are
shown on screen from the latest result. Press [Prev] and [Next] button for real
time search option.
3) Queue Process
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2.4.1.4 Menu
Option
M
Manage Data
E
N ID Register
Calibration Reset
Error History
1) Option
[Fig. 2.2]
*Important Notice
The following options can be selected or adjusted only in [Admin Mode]. Go to page #
33~34 of this manual [Admin Mode] for detailed instruction before starting the test.
1.Language select 2. Standalone 3. Test order 4. Strip select
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2) Manage DATA
[ Fig. 2.3 ] [ Fig. 2.4 ]
This menu provides the functions to search, print, delete, transfer all
measurement results. It allows users to export data to the external memory
devices.
1. Press [New Search] button in [Fig. 2.3] to display [Fig. 2.4], [Input
Search Condition] window. User can change the condition for below
parameters.
Type: select desired type: [Routine], [Emergency], [QC Test] or [All].
Date(Start): select the first date.
Date(End) : select the last date.
Serial #(Start) : select the start number from 0001 to 9999 for serial
number area.
Serial #(End) : select the start number from 0001 to 9999 for serial
number area.
ID # : select the ID number.
Flag : this is to do conditional search for the test results: [All], [Normal],
[Abnormal], [Sieve], [Error]. User can set the ranges for abnormal and
sieve in the range table.
2. Press [Recent Data] to list up the latest data(100 samples)
3. The searching results will be displayed on the [Data List] window.
Review the selected sample result with its color development by
pressing [Image View]button.
*At the [Image View], user can see other results by pressing [Previous]
or [Next] button as well as print-out by pressing [Print] button.
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[ Fig. 2.5 ]
4. User can save all data or the selected data in external device, print,
delete, transfer to interface by pressing [Export], [Transfer], [Print] and
[Delete]
[ Fig. 2.6 ]
3) ID Register
[ Fig. 2.7 ] [ Fig. 2.8 ]
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4) Range Table
[ Fig. 2.9 ]
This window shows the information about each test item, the contents are
as follows.
1. Grade : concentration of each grade
2. Conv / Unit : unit of result (Conversion unit) ex) mg/dL
3. SI / Unit : unit of result (International system of unit) ex) mmol/L
4. Range Low, High : the min. and max. raw data of each grade.
5. Abnormal : if the blank is marked with a tick, the marked grade is
displayed as abnormal data.
6. Sieve: if the blank is marked with a tick, the marked grade is
displayed as [Sieve Data].
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5) Quality Control
Go to [Menu] → [Quality Control] to set QC(quality control).
At the [Quality Control] window, there are two menus: [Quality Control
Config] & [QC Management Program].
The procedure is the same as menu 2.4.5, 2)[Manage Data].
[ Fig. 2.10 ]
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[Fig. 2.11]
[Fig. 2.12]
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6) Calibration
[ Fig. 2.19 ]
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It is to check that the raw data of the strip for calibration whether it is within the
normal range (page 47) and to reset the standard value for each test portion.
Calibration Range
BLD: 500~515, BIL: 500~515, CRE: 500~515, URO: 500~515, KET: 500~515,
PRO: 500~515, ALB : 500~515, NIT: 500~515, GLU: 500~515, pH: 500~515,
LEU: 500~515, VTC: 500~515, COL: 500~515
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7) Maintenance
[ Fig. 2.20 ]
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8) Mode Change
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Two operating mode are available which are [User] &[ Admin mode]. The
default setting is [User mode]. When changing [User mode] to [Admin
mode], press [Admin Mode] and input the password. To change the
password, press [Change Admin mode] in admin mode and input the new
password. At [Admin mode], user can modify the stored result, select the
language which set in [Option] menu and set the analyzer type, strip order
and strip type.
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[ Fig. 2.33]
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The test strips are stable in the tightly closed cassette compartment for fourteen
days. After this time, a warning window is displayed on the screen, and the cassette
must be replaced by a new one.
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1) Only use the strip cassette for the Super+ which has not exceeded its expiration
date as printed on the label.
2) Store the strip cassette at the temperature between 2-30°C (36-86°F).
3) Check the package for damage before use.
4) After opening the cassette from the package, check whether the test strip layers
are correctly aligned and the color of pads is OK to use.
5) Do not directly touch the test pads on the test strip.
6) Do not let the strips come in contact with water or with any volatile, strongly
acidic, or alkaline chemicals.
7) Install the cassette into the analyzer within 3 minutes after opening the aluminum
bag.
8) Keep the cassette in the firmly locked cassette compartment until the test strips
are completely used up.
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9) Do not open the cassette compartment door as long as the cassette is not empty
or its on-board stability has not expired.
10) Follow the instruction for use provided with the URISCAN Super+ cassette and
read carefully all information in the package insert.
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Chapter 3 Operation
This chapter describes how to operate the URiSCAN Super+
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The built-in barcode reader automatically scans the barcode of each sample. Also, the
specimen ID can be manually registered by pressing LCD screen, or using a keyboard or an
external barcode reader.
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[ Fig. 3.1 ]
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[ Fig. 3.2 ]
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1. Serial Number Auto Reset : under the normal mode, the sequential
identification number is automatically incremented with each sample.
under [Daily Auto Reset], the sequential identification number is
automatically reset every single day
2. Routine / Emergency / Control Serial #
The serial number can be set for each mode.
3. Operator ID : input the operator ID
4. Representative unit : set unit (SI unit, CONV.unit)
5. Printer Driver : select the connected printer. The BIXOLON STP-103II
should be selected when the thermal and dot printer are parallel connected.
6. Result Print : set the print option for patient results
7. Calibration Print : set the printer option for calibration results
8. Sample Mixing : set the specimen mixing option
9. Rinse Counter : set the number of rinsing from 1 to 5 times, or until empty.
10. QC test tube Barcode : set the control tube by inputting barcode number.
11. Rinse Tube Barcode : set the rinse tube by inputting barcode number.
12. End Tube Barcode : set the end tube to finish the test by inputting
barcode number.
13. Water Supply Tank Alarm : press the change button to On/Off the water
level sensor.
14. Waste Liquid Tank Alarm : press the change button to On/Off the water
level sensor.
15. NUM. of strips for Tray-full warning : press the change button to
modify the quantities of remaining strips.
16. NUM. of strips for few-strip Notice : press the change button to set up
alarm for remaining strips.
17. Control data auto transfer : press the change button to set up auto
transfer the quality control data(RS232C) to an interface program.
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3) Start measurement
Check the expiry date of the installed cassette before starting the measurement.
※ Note: the strip cassette is stable for 14days after installing in the instrument. If the
expiry date of the cassette has passed, the alarm sign automatically pops up.
4 cm
Range : 6 cm
2 cm
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Once the strip is loaded from the cassette, the strip sensor detects the existence
of strip, and the routine or emergency serial number is incremented one by one.
The number of remaining strip is decreased one by one. The processing queue
on [Main] screen shows the operating status of each sample. The measurement
process is as follows:
The test result of processed sample shows on left side of [Main] screen with the
image output.
Pressing [Prev] and [Next] button enables user to search the previous and next
result.
1) End measurement
If there is no sample rack is detected by the rack input sensor of input line, the
analyzer will be changed to [End Routine] to finish its measurement after
finishing the aspiration for the last test strip. When the 10 racks are loaded on
the output line after measurement, alarm message will appear by the rack
output sensor, and automatically changes to [Pause].
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The samples which are finished the Aspiration will go to next step, sample
dropping, and measurement will be continued. [Pause] means that the sample
rack stops and the test strips on which the samples are already dropped
continue measurement.
3) Restart measurement
Press [Continue] button to run test. The measurement process will restart.
The sample can be tested additionally by [Routine Test], [Pause], [Ready mode].
2) [Pause] Mode
* Place additional sample rack in the rack input line.
* Press [Continue] on [Main] screen, [Pause] mode is changed to operation
mode and measurement mode is restarted. The sample rack is moved to
cross-feed line.
3) Ready Mode
* Prepare the additional sample rack in the rack loading line.
* The test procedure is the same as starting the measurement.
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Place the sample in emergency area and press [Emergency] button on [Main]
screen. The emergency sample will be tested first while the routine sampling
(measurement) is performing.
The routine sampling test will be stopped if you press [Emergency] button.
The specimen ID can be input by manually or using the connected barcode reader.
The routine test is started continually once the measurement is finished
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The Instrument will have alarm message and go to [Pause] mode if strip runs out
while the testing or the stability (14 days) has been passed. In this case, the
instrument will automatically display [Change. Cassette] mode and you need to
change new strip cassette. The alarm message will appear when the remaining
strip number is smaller than the set amount in NUM of strips for few-strip notice in
[Option], so user needs to prepare the new strip cassette.
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1) QC Test
The processing of measurement will be same as [Routine test] mode. Load the
quality control materials on the Rack as the number of control level. In
URiTROL case, place the Level 1(Normal) on the tube position 1, the Level
2(Abnormal) on the tube position 2, and Level 3(Abnormal) on the tube position
3. Match the number of tube position and quality control level, the quality
control test results will be shown and stored with its image.
[ Fig. 3.4 ]
2) Quality Control
Control Data. (Same as [Manage DATA] menu)
Set in [Menu] → [Quality Control]
a) New Search : Review the Data. The options are same as follows:
Date (Start) – search by date (from the start date)
Date (End) – search by date (from the end date)
Serial # (Start) – search by serial number (from the start #)
Serial # (End) – search by serial number (from the end #)
ID No. – search by control ID
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[ Fig. 3.7 ]
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Set the material information of quality control or mange the allowed acceptable
range for each items.
a) Name – set the brand/model name of quality control materials (e.g:
URiTROL, Bio-Rad)
b) Num. of Level – set the number of Quality Control level and its quantity
(eg: URiTROL has 3 different levels)
c) Lot # – set the LOT number of Quality Control materials
d) Expiration Date – set the expiry date of Quality Control materials.
e) Test item – set the allowed test limitation for each items and levels.
4) QC management program
[ Fig. 3.8 ]
[Control Management] program shows up the control data via report type and chart
type, and it can be printed out to default printer (A4 size only).
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Chapter4 Maintenance
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1) The sample pipette and internal tube should be rinsed once a day by Rinse
additive.
2) Empty the strip waste container.
3) Fill up the distilled water in the water supply tank.
4) Check the waste liquid tank
1) Clean the guide plate. If it has contaminated with urine sample, it needs to be
cleaned.
2) Clean the rack transfer base. It must be free from dust and urine contaminant.
3) Check whether or not there is an infection of bacteria or algae in the water
supply tank (distilled water).
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4.2.1 Reset
It is to initialize the operation. Pressing [RESET] button removes the rack of cross-
feed line. Locate the pipette in the right position and makes the syringe measure
mode.
4.2.3 Rinse
At the end of each working day, the sample needle and inner tube must be rinsed in
order to protect from the contamination by urine specimen.
1) Place a tube with rinsing solution at the position No.1 of the rinse rack
2) Select the number of repetition for rinse on [Menu] → [Option].
3) Place the Rinse rack at the emergency position. (※ The position No.1 of the
rinse rack, where the tube with rinsing solution is placed, should face toward
the pipette.)
4) Press [Rinse] button on the [Menu] → [Maintenance].
5) The system performs rinsing.
6) The Rinse rack should not be removed during the job.
You can check the details of error in the past: date, classification, number, etc
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Warning 04-006 Please check the Waste-tank liquid level! Check the waste-tank
Please check the Rack-input approach sensing Check the sensor in Rack-input
Warning 07-007 area! Forward.
Warning 16-007 Take out the Waste-box and dump trash! Empty Waste-tray.
5.1.2 ERROR
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ERROR 01-007 Pipette Level-detect_sensor ERROR! Contact Technical support team of YD.
Sensor problem
ERROR 05-004 Cassette Row_sensor ERROR! Contact Technical support team of YD.
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Chapter 6 Appendix
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6.1 Communications
This section is to explain the interfacing with host computer, barcode reader, external
printer.
There are many different ways of interfacing the system. URiSCAN Super+ is using
serial communication which is widely used.
► RS232C cable is used for the communication between host computer and
URiSCAN Super+.
► Once data communication is open, [Start Code] will be transmitted to host
computer from URiSCAN Super+, and then data will be transmitted to host
computer in ASCii code.
► Data Transmission order follows printing-out order. [Line Feed] (hereafter ‘LF’)
and [Carriage Return] (hereafter ‘CR’) will be transmitted at the end of each
Line.
► Start Code, end, LF, CR are in hexa decimal, while other data transmit in ASCii
code.
1) Data Format
Baud Rate (bps) : 1200, 2400, 4800, 9600, 19.2K, 38.4K, 57.6K, 115.2K
Data Bit (bit) : 7 or 8-bit code
Parity Bit (bit) : None, Odd, Even
Stop Bit (bit) : 1 or 2 stop bits
2) Hardware Connection
TX 2 2 TX
RX 3 3 RX
GND 5 5 GND
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► With the internal barcode reader in URiSCAN Super+ , the external barcode
reader also can be used.
► External barcode reader to URiSCAN Super+ can be connected only through
PS/2(keyboard) port and USB port.
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「*」stands for the sensitivity, it is the first positive result detected by URiSCAN
Super.
Blood
Printout Arbitrary - ± + ++ +++
Printout Conv. unit neg 5 10 50 250 RBC/µL
Printout SI unit neg 5 10 50 250 RBC/µL
Concentration Ranges 0~4 5*~7 8~29 30~140 141[
Bilirubin
Printout Arbitrary - + ++ +++
Printout Conv. unit neg 0.5 1.0 3.0 mg/dL
Printout SI unit neg 9 17 50 µmol/L
Concentration Ranges 0~0.4 0.5*~0.7 0.8~1.9 2.0[
Creatinine
Printout Arbitrary ± + ++ +++ ++++
Printout Conv. unit mg/dL
Printout SI unit µmol/L
Concentration Ranges
Urobilinogen
Printout Arbitrary ± + ++ +++ ++++
Printout Conv. unit 0.1 1.0 4.0 8.0 12.0 mg/dL
Printout SI unit 1.6 16 66 131 197 µmol/L
Concentration Ranges 0.1~1.0 2.0*~2.9 3.0~6.0 7.0~10.0 11.0[
Ketones
Printout Arbitrary - ± + ++ +++
Printout Conv. unit neg 5 10 50 100 mg/dL
Printout SI unit neg 0.1 1 5 10 mmol/L
Concentration Ranges 0~4 5*~7 8~29 30~74 75[
Protein
Printout Arbitrary - ± + ++ +++ ++++
Printout Conv. unit neg 10 30 100 300 1000 mg/dL
Printout SI unit neg 0.1 0.3 1 3 10 g/L
Concentration Ranges 0~20 21*~50 51~80 81~200 201~600 601[
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Micro Albumin
Printout Arbitrary - ± + ++ +++ ++++
Printout Conv. unit neg mg/dL
Printout SI unit neg g/L
Concentration Ranges 0~29
Nitrite
Printout Arbitrary - +
Printout Conv. unit neg pos
Printout SI unit neg pos
Concentration Ranges 0~0.04 0.5[*
Glucose
Printout Arbitrary - ± + ++ +++
Printout Conv. unit neg 100 250 500 1000 mg/dL
Printout SI unit neg 5.5 14 28 55 mmol/L
Concentration Ranges 0~49 50*~175 176~375 376~750 751~1499
pH
Printout Conv. unit 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0
Printout SI unit 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0
Concentration
]5.2 5.3~5.7 5.8~6.2 6.3~6.7 6.8~7.2 7.3~7.7 7.8~8.2 8.3~8.7 8.8[
Ranges
Leucocytes
Printout Arbitrary - ± + ++ +++
Printout Conv. unit neg 10 25 75 500 WBC/µL
Printout SI unit neg 10 25 75 500 WBC/µL
Concentration
0~9 10*~17 18~60 61~300 301[
Ranges
Ascorbic acid
Printout Arbitrary - + ++ +++
Printout Conv. Unit neg 10 25 50 mg/dL
Printout SI unit neg 0.6 1.4 2.8 mmol/L
Concentration
0~9 10*~16 17~35 36[
Ranges
Operator Manual / 65
URiSCAN Super+ Fully automated urine analyzer Rev.02
mg/dL
Microalbumin ALB
mol/L
Nitrite NIT - +
Operator Manual / 66
URiSCAN Super+ Fully automated urine analyzer Rev.02
Care diagnostica
46562 Voerde, Weseler Str. 110, Germany
Operator Manual / 67