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ISO 9001

REGISTERED
QUALITY SYSTEM

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URiSCAN Pro+ urine analyzer

Service Handbook
( for service person )

Published
by
YD Diagnostics
Quality Assurance Department

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Index

1. Components
1.1 Front View of URiSCAN PRO+ /4
1.2 Inside of URiSCAN PRO+ /5

2. Cleaning the Instrument


2.1 Purpose /6
2.2 Methods /6
2.3 Cautions / 11

3. Quality Control
3.1 Cautions during Quality Control Procedure / 12
3.2 Reference / 13

4. Adjusting and Replacing the Sensors


4.1 Introduction / 14
4.2 Carrier Sensor / 15
4.3 Feeder Sensor / 19
4.4 Strip IR Loading Sensor / 20

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5. Adjusting of %R
5.1 Adjusting %R of Each Portions / 25
5.2 How to Change Testing Order in Printing / 31
5.3 Initial %R of URiSCAN PRO / 33
5.4 Initial %R of 1.79E ROM Version / 34
5.5 Initial %R of 1.79ED ROM Version / 35

6. Connection with Hyper Terminal on the Host Computer


/ 36

7. Using Hidden Keys


7.1 Adjusting Hardware Mode / 38
7.2 Test Mode / 39

8. Trouble Shooting
8.1 Trouble Shooting / 42
8.2 Warning Message / 46
8.3 Service Check List / 47
8.4 Error Code List / 49

9. Annex
9.1 Comparison Specification of Urine Analyzer / 50

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1. Components

1.1 Front view of the URiSCAN PRO+

Print Holder

LCD

Process Lamp

Strip Feeder

Keyboard

Rake Guide Plate O/F Module Cap

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1.2 Inside view of the URiSCAN PRO+

SMPS

Mainboard

Printer

Strip Carrier Belt

Strip holder module CCD Bracket Module

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2. Cleaning the instrument

2.1 Purpose

To keep the instrument working properly, it is strongly recommended to clean the


instrument regularly. Contaminant from urine can interfere correct results, so it should be
removed prior to measure the samples. Cleaning of instrument is one of the most
important taking cares to give accurate results along with internal quality control of the
instrument.

2.2 Methods

The essential parts to be washed are rake, guide plate, optical fiber part and strip
stabilizer as described below.

① The rake is set on the Strip feeder

② Guide plate

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③ Optical fiber threshold portion at the lower part of the CCD bracket module

④ Strip stabilizer (metallic part)

The feeder and guide plate which are separated from instrument can be washed with
brush or soft cloth to eliminate the residues. When you clean the guide plate, please be
careful not to make any damages(scratch..) on the surface. It is also a good method to
wash the guide plate with a lint-free cloth dampened with soapy water. In case of
cleaning the CCD bracket and strip stabilizer, washing with alcohol cotton wrapped up in
gauze (unless the cotton fiber may be attached on the instrument) is more effective.
When you clean the lower CCD bracket module and stabilizer, it is recommended to
separate the whole CCD bracket module from the instrument instead of separating the
optical fiber part only.

2.2.1 Cleaning the CCD bracket

Remove the O/F(optical fiber) module cap.

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1 2

The CCD bracket module is fixed by two screws.

Take off two screws from the CCD bracket module by using a screwdriver

Clean the strip stabilizer with cotton dampened with 70% ethyl alcohol.

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Clean the optical fiber threshold portion

Warning) You should handle the optical fiber carefully not to be disconnected or broken.

When you assemble the CCD bracket module, you should align at the accurate position
of CCD bracket like below figure.

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2.2.2 Cleaning the Strip Carrier Belt

There are two strip carrier belts in the strip holder module. The upper one is easier to
be contaminated than the lower one because the upper strip carrier belt is contacted with
the sample urine directly but lower strip carrier belt is not directly contacted with sample
urine.

Two belts have 24pins each and we need to clean each pins respectively like below
figure. cotton dampened with 70% ethyl alcohol and wrapped up with gauze is very
efficient.

If the strip carrier module is extremely contaminated with dried urine residue, it need to
open the upper cover of instrument and clean the strip holder module thoroughly in every
corner.
If the urine residue cannot be easily removed, you can use screwdriver (type ‘-‘) to
wipe it out. But Do not make any damages on the instrument as described.

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When the cleaning instrument is completed, reassemble the instrument to the former
condition, perform calibration and then perform the internal quality control procedure
finally.

Among the Cleaning procedures, only two things, washing rake and guide plate, can be
easily done by the hospital operator but the rest procedures(Cleaning the CCD bracket,
Strip carrier belt and Strip holder module) should be done by trained service person.
Therefore service team of the each YD representatives have to visit customer’s laboratory
and maintain the instrument routinely.

2.3 Cautions

The excessive urine on the test strip pad may induce serious contamination of instrument.
So when you visit new customer or install the instrument at first time, you should ensure
to user not to make any excessive urine on the strip because the excessive urine may
cause the false-negative or false-positive results. In addition, it is recommended to train
them to be familiar with the basic cleaning procedure(Clean rake and guide plate) daily.

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3. Quality Control

The instrument must be checked by the internal Quality Control Procedure


routinely to obtain reliable test results and maintain the proper working. In this
chapter, we’ll learn about the cautions when service person perform Quality
Control procedure.

3.1 Cautions during Quality Control Procedure

To reduce the discrepancy of results from urine control solution, the


URiSCAN instrument should be cleaned up before the Quality Control.

To prevent the contamination of urine control solution, proper volume


of urine control solution should be taken by the proper apparatus such
as serum seperator or dropper then apply dropping method not
dipping method to the strip. If you use dipping method without
dropping method, chemical elements in the strip can be released into
the control solution, then the chemical nature of control solution can
be changed. Do not dip the test strip into the control solution directly
up to 5 times.

All of the data from the internal Quality Control should be filed under
the rules of each laboratory.

You should always check the expiration date of urine control solution
to eliminate incorrect results.
( The URiTROL level 1,3 is stable for 10 days after reconstitution and the
URiTROL level 2 is stable for 24 hours after reconstitution )

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3.2 Reference
3.2.1 Acceptable range of URiTROL urinalysis control (YD Diagnostics)
Test portion LEVEL 1 LEVEL 2 LEVEL 3
Blood Neg 2~3+
Bilirubin Neg Neg 2~3+
Urobilinogen Norm Norm
Ketone Neg 2~3+
Protein Neg Neg 2~4+
Nitrite Neg Positive
Glucose Neg 2~4+
PH 5.0~7.0 6.0~8.0
SG 1.020~>=1.030 <=1.005~1.010
Leucocytes Neg 2~3+
Vitamin C 1~3+ Neg
URiTROL LEVEL 3 should be applied only for Blirubin and Protein portions.
(It is allowed to Ignore the results of other portions)

3.2.2 Example of acceptable range of LiquiCheck urinalysis control (Bio Rad)


( For using URiSCAN reagent strip )
Test portion LEVEL 1 LEVEL 2
Blood Neg 2~3+
Bilirubin Neg 2~3+
Urobilinogen Norm 3~4+
Ketone Neg trace~2+
Protein Neg 2~4+
Nitrite Neg Positive
Glucose Neg Trace~2+
PH 5.0~6.5 6.0~7.0
SG 1.015~1.025 1.015~>=1.030
Leucocytes Neg 2~3+

☞ Accurate acceptable range for URiSCAN instrument is noted in the insert paper
of each urine control every lot number.

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4. Adjusting and Replacing the Sensors

4.1 Introduction

URiSCAN PRO+ urine instrument has 3 different sensors. Each sensor is essential for
physical movement of the instrument.

Sensors installed in the instrument are described below (see the below),

① Carrier Sensor : Help the strip set on the accurate position


(measuring position).
② Feeder Sensor : Detect the position of Strip Feeder.
③ Strip IR Loading Sensor : Detect the strip which is to be measured on the
guide plate
( Including light emitting part and light absorption part )

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4.2 Carrier Sensor

Carrier sensor is a photo coupler type sensor. It is located under strip carrier belt in the
strip holder module. Carrier sensor has been aligned and glued at the exact position
initially.

The principle of carrier sensor is as follows.


- The sensor detect one pin among the 24 pins on the strip carrier belt
- This information is sent to CPU
- CPU controls the carrier motor to be stopped

Therefore, in case of malfunction of strip carrier, check the carrier sensor first (look at
the sensor carefully whether some dusts or particles exist inside of the sensor) and if
there is no doubt for the sensor visually, replace with new one and check again. Secondly,
proceed Carrier Sensor Alignment procedure described below if the carrier acts normally.

4.2.1 Carrier Sensor Alignment Procedure

1. Remove upper case of URiSCAN instrument

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2. Place the guide plate

3. Remove optical fiber module in the CCD bracket by removing thumb screw.

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4. Place URiSCAN strips between the pins on the strip carrier belt.

5. Select mover menu by pressing 5-9-2 from main menu on the instrument.

6. Select mecha test (#9) then the carrier belt moves step by step and Press ESC
key when you check the alignment ( 9-ESC-check alignment-9-ESC-check
alignment-…) and whenever you want to stop the carrier belt. At this time you
can check whether the strips are on the accurate position (measuring position
on the guide plate ) or not by looking at the CCD bracket vertically. If the strip
is on the right-handed side from the measuring position, you can adjust the
position of the carrier sensor to inside of strip holder module as much as
deviation of the strip position. If the strip is on the left-handed position, you
can adjust the sensor to the outside of strip holder module as described. Then
you can set on the strip at the accurate measuring position.

Left-handed position Right-handed position

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Adjusting the position of carrier sensor

Alignment of the carrier sensor is done.

7. Check all the pins on the strip carrier belt (24pins/belt) have a good alignment
by applying no.6 procedure repeatedly for each 24 pins.

8. After this alignment procedure, glue the carrier sensor with an adhesive tightly.

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4.3 Feeder sensor

Feeder sensor located under the printer module detects where the Strip feeder is
positioned and generates a signal to send CPU, which controls the feeder motor. As
similar as carrier sensor, some dust or particles may affect the sensor and may cause
dysfunction of feeder.

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4.4 Strip IR loading sensor

4.4.1 General description

Strip IR loading sensor is consisted of two parts.


- IR diode (light emitting part) : located inside of process lamp
- IR transistor (light absorption part) : located under guide plate and consisted of
13 IR transistors.

IR diode (inside)

Process lamp

IR transistor

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The principle of strip IR loading sensor is as follows.


① The test strip is located between these two parts of sensor
② signal which is generated from IR loading sensor is sent to CPU to control
feeder motor when at least one of the 13 different sensor figures is exceeded
1000.
③ Feeder acts to move the test strip to the carrier belt.

To detect the strip on the detection area, the sensor figure must be exceeded 1000.
And this sensor figure can be read by using hyper terminal of host computer. ( See
chapter 5. Connection with hyper terminal on the host computer )
Allow following steps to read sensor figure. ( See 7.2 Test Mode )
1. Connect URiSCAN instrument and host computer with RS-232C cable. And be
sure that the communication status is “ON” in the instrument.
2. Execute hyper terminal on host computer.
3. Set the instrument to “T” mode (test mode) by pressing “9-9-9” from main
menu then press “5-7-esc-2-7-esc” to achieve “ST” mode. (see the details
on chapter 6)
4. Select “1.measurement” menu, then 13 different figures will be shown. These
are the sensor figure for 13 IR transistors respectively.
The normal range of sensor figure is 160~250.
5. When you place the strip on the detectable area, the corresponded transistor’s
sensor figure will be increased.

In case of malfunction of the strip IR sensor, following steps are needed to be followed.

4.4.2 Adjust sensor sensitivity (1000 is the initial sensor sensitivity)

Select ‘1.sensor’ menu by pressing 5-9-1 from main menu of instrument. If the
sensitivity figure is increased, the practical sensor sensitivity should be decresed(sensor
will be operated more dull) and if the sensitivity figure is decreased, the practical sensor
sensitivity should be increased (sensor will be operated more sensitive). See the below
table.

Sensitivity figure of instrument Real sensitivity


Case 1 Increased Decreased
Case 2 Decreased Increased

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4.4.3 Adjust electric volume resistance

If one or more sensor figures are out of range, we can adjust the electric volume
resistance in the main board by using “+” screwdriver.
The acceptable range of sensor figure : 160~250
See the details below.

206 188 173 177 166 167 172 204 172 175 181 186 172
206 188 173 177 166 167 171 204 172 175 181 186 172
205 188 173 177 166 168 171 204 172 175 182 186 172
205 187 172 176 166 168 171 205 172 175 182 186 173
205 187 172 176 166 168 171 205 172 175 182 185 173
205 188 172 176 166 167 172 204 172 175 181 186 172
206 188 172 176 166 167 171 204 172 175 181 186 172
206 188 172 176 166 168 172 204 172 174 182 186 172
206 187 173 177 166 168 172 205 172 174 182 186 173
206 187 171 177 166 168 172 205 172 174 182 185 173
206 187 171 175 166 168 172 205 172 174 182 185 173
205 187 173 175 166 168 172 205 172 174 182 185 173
205 187 173 177 166 168 171 205 172 175 182 185 173
206 187 173 177 166 168 171 205 172 175 182 185 173
206 187 172 177 166 168 171 205 172 175 182 185 173

< This is a normal state of sensor figures >

Example)

206 186 173 175 166 167 171 204 172 176 180 311 279
207 186 173 175 166 166 171 203 171 176 180 310 280
205 186 170 175 166 166 171 203 171 174 181 311 280
205 188 170 177 164 166 171 203 172 175 182 311 278
205 188 172 176 164 167 171 204 172 174 182 310 279
206 187 173 176 166 167 172 204 171 174 181 310 280
205 187 173 177 166 167 173 204 172 175 181 312 279
206 187 173 177 165 165 173 204 172 175 181 312 281
206 187 174 176 165 165 172 204 172 175 180 312 281
204 188 173 176 165 165 172 203 172 175 180 310 280
204 187 173 176 166 165 172 203 172 176 180 313 279
204 188 173 176 166 167 173 204 172 176 182 313 280
206 186 174 176 168 167 172 205 172 176 183 312 281
204 186 174 177 168 166 174 205 173 176 181 311 282
206 187 173 178 167 167 174 204 173 176 183 311 282
206 188 176 178 167 166 171 205 173 175 182 313 281
207 188 176 177 168 167 171 204 172 175 182 312 279

< two sensor figures from right are increased, it is needed to be adjusted >

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The 13 different sensor figures and 4 different electric volume resistance are related as
described below figure.

to hyper terminal on host computer ( ST mode )


< related position’s sensor figure ( left to right ) >

206 188 173 177 166 167 172 204 172 175 181 186 172
206 188 173 177 166 167 171 204 172 175 181 186 172
205 188 173 177 166 168 171 204 172 175 182 186 172
205 187 172 176 166 168 171 205 172 175 182 186 173
205 187 172 176 166 168 171 205 172 175 182 185 173
205 188 172 176 166 167 172 204 172 175 181 186 172
206 188 172 176 166 167 171 204 172 175 181 186 172
206 188 172 176 166 168 172 204 172 174 182 186 172
206 187 173 177 166 168 172 205 172 174 182 186 173
206 187 171 177 166 168 172 205 172 174 182 185 173
206 187 171 175 166 168 172 205 172 174 182 185 173
205 187 173 175 166 168 172 205 172 174 182 185 173
205 187 173 177 166 168 171 205 172 175 182 185 173

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The volume resistance can be adjusted to clockwise or counter-clockwise directions. If


you want to increase the sensor figure, you should adjust the related resistance to
clockwise direction carefully. As the same way, you can decrease the sensor figures by
adjusting the related volume resistance to counter-clockwise direction.
Each volume resistance should be handled very slowly because only small adjustment
of the resistance may cause large fluctuation of sensor figure.

So, in case of the example situation (21 page), the first volume resistance from right
should be adjusted to counter-clockwise direction carefully.

When you replace the IR loading sensor, you should replace all of two different parts of
the sensor. And the two guide plates which are initially packed with instrument should be
used. When you need to replace the guide plate by some reason (serious contamination,
broken etc..), replace with new one, then you should check that the sensor figures are fit
in the normal range.

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5. Adjusting of %R

5.1 Adjusting %R of each portions

① Press “ 7 “ from main menu then LCD shows below.

16:16:48
Enter Password
[* * * * * * *]

Use Key: ENT ESC

② Input “1111111” which is initially set password on the instrument and press ENT.

1. Change %R
2. Change Test Order

Use Key: ENT ESC

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③ Choose 1. Change %R then use 4 different arrow key (up,down,left,right) to move


select mark( “ > ”) in front of the item which you want to adjust and press ENT.

*** Select Parameter for Change

> 1. BLD 5. PRO 9. S.G


2. BIL 6. NIT 10. LEU
3. URO 7. GLU 11. VTC
4. KET 8. pH

Use Key: ARROW ENT ESC

④ Ready to adjust Blood portion %R (example)

*** Change %R for [BLD]


- neg <= [20]
± 5 <= [60] *
+ 10 <= [110]
++ 50 <= [205]
+++ 250 > [205]

****
Use Key: ENT ESC

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5.1.1 Practical Examples

5.1.1.1 Change the trace result(±) to the negative result(-) of blood portion.
: Use arrow key to move the shaded area on “±” mark, then press ENT to change the
grade mark to “-“ (when you press ENT key repeatedly, the figure or mark under
shaded area will be changed sequentially.) as the same way change “5” to “neg”
as described below figure.

*** Change %R for [BLD]


- neg <= [20]
- neg <= [60]
+ 10 <= [110] *
++ 50 <= [205]
+++ 250 > [205]

****
Use Key: ENT ESC

5.1.1.2 Adjust the sensitivity of each grade


: In case of customer want to increase the sensitivity of “±” grade in blood portion.
( Increasing sensitivity of low level of Blood portion on request )

Decrease the %R of trace grade by using arrow key and number key
Example) [60] --- [45] as described below figure

*** Change %R for [BLD]


- neg <= [20]
± neg <= [45] *
+ 10 <= [110]
++ 50 <= [205]
+++ 250 > [205]

****
Use Key: ENT ESC

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5.1.1.3 Delete “++++“ grade of protein portion

*** Change %R for [PRO]


- neg <= [45] ****
± 10 <= [60] *
+ 30 <= [80]
++ 100 <= [130]
+++ 300 <= [150]
++++ 1000 > [150]

Use Key: ENT ESC

: Place the shade on the “++++ “ mark, then press ENT key repeatedly until
“ * * * * “ mark is shown as described below figure.

*** Change %R for [PRO]


- neg <= [45]
± 10 <= [60] *
+ 30 <= [80]
++ 100 <= [130]
+++ 300 > [130]
****

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5.1.2 Abnormal result printing

You must always check the “*” mark (the result below this mark will be shown to
abnormal shade on the printed and LCD displayed result) after adjusting %R. You can
always print the %R grade by pressing “R” or “E” key through the internal printer. So it is
recommended that print initial %R grade primarily, then adjust the %R grade and show
them to the hospital operator.

*** Change %R for [BLD]


- neg <= [20]
- neg <= [45]
+ 10 <= [130] *
++ 50 <= [205]
+++ 250 > [205]

****
Use Key: ENT ESC

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5.1.3 Examples for Adjusting %R in a special situation

5.1.3.1 Adjust bilirubin portion %R to the grade of competitor’s instrument.


- neg <= [15] - neg <= [30]
+ 0.5 <= [30] =========> + 1.0 <= [68]
++ 1.0 <= [68] ++ 3.0 <= [90]
+++ 3.0 > [68] +++ 6.0 > [90]
(URiSCAN) (R brand)

5.1.3.2 Adjust the %R of pH portion


- One of competitor’s instrument cannot display some grades (5.5, 7.5, 8.5) in pH grade.
Following figure shows that pH portion has been adjusted (5.5, 7.5 and 8.5 results cannot
be easily analyzed)

5.0 <= [5] 5.0 <= [30]


5.5 <= [30] 5.5 <= [31]
6.0 <= [70] 6.0 <= [70]
6.5 <= [125] 6.5 <= [125]
7.0 <= [175] =========> 7.0 <= [185]
7.5 <= [240] 7.5 <= [186]
8.0 <= [300] 8.0 <= [310]
8.5 <= [330] 8.5 <= [311]
9.0 > [330] 9.0 > [311]

5.1.3.3 Adjust Leucocytes portion %R to the grade of competitor’s instrument.


- neg <= [6] - neg <= [6]
± 10 <= [13] ± 25 <= [13]
+ 25 <= [23] =========> + 100 <= [45]
++ 75 <= [45] ++ 500 > [45]
+++ 500 > [45] *****

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5.2 How to change testing order in printing

① Select 2. Change Test Order

1. Change %R
2. Change Test Order

Use Key: ENT ESC

② Example : replacing [BLD] with [S.G]

In this menu, go to Bld via direction key (up, down) and replace it by SG via direction
key (left, right). Also, do the same way in SG portion to replace it by Bld. After adjusting,
press ENT or ESC, then the changed test order will be saved and activated.

(Caution: Do not save with duplicated item as described below figure ([SG] is
duplicated))

*** Change Test Order


S.G GLU
BIL pH
URO S.G
KET LEU
PRO VIT
NIT

Use Key: ARROW ENT ESC

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③ To store this change, press ENT or ESC key.

*** Change Test Order


S.G GLU
BIL pH
URO BLD
KET LEU
PRO VIT
NIT

Use Key: ARROW ENT ESC

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5.3 Initial %R of URiSCAN PRO ROM version


1. Blood 2. Bilirubin 3. Urobilinogen
Change %R for BLD. Change %R for BIL. Change %R for URO.
- neg <= [20] - neg <= [15] ± norm <= [25]
± 5 <= [60] + 0.5 <= [30] + 1.0 <= [45]
+ 10 <= [110] ++ 1.0 <= [68] ++ 4.0 <= [69]
++ 50 <= [205] +++ 3.0 > [68] +++ 8.0 <= [98]
+++ 250 > [205] ++++ 12.0 > [98]
4. Ketones 5. Protein 6. Nitrite
Change %R for KET. Change %R for PRO. Change %R for NIT.
- neg <= [15] - neg <= [18] - neg <= [10]
± 5 <= [35] ± 10 <= [28] + pos > [10]
+ 10 <= [80] + 30 <= [50]
++ 50 <= [110] ++ 100 <= [90]
+++ 100 > [110] +++ 300 <= [117]
++++ 1000 > [117]
7. Glucose 8. pH 9. S.G.
Change %R for GLU. Change %R for pH Change %R for S.G.
- neg <= [15] 5.0 <= [5] <= 1.005 <= [60]
± 100 <= [80] 5.5 <= [30] 1.010 <= [115]
+ 250 <= [125] 6.0 <= [70] 1.015 <= [170]
++ 500 <= [180] 6.5 <= [125] 1.020 <= [205]
+++ 1000 <= [240] 7.0 <= [175] 1.025 <= [249]
++++ 2000 > [240] 7.5 <= [240] >= 1.030 > [249]
8.0 <= [300]
8.5 <= [330]
9.0 > [330]
10. Leucocyte 11. Vitamin-C
Change %R for LEU. Change %R for VTC.
- neg <= [6] - neg <= [20]
± 10 <= [13] + 10 <= [80]
+ 25 <= [23] ++ 25 <= [105]
++ 75 <= [45] +++ 50 > [105]
+++ 500 > [45]

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5.4 Initial %R of URiSCAN PRO+ 1.79 E ROM version


1. Blood 2. Bilirubin 3. Urobilinogen
Change %R for BLD. Change %R for BIL. Change %R for URO.
- neg <= [20] - neg <= [15] ± norm <= [25]
± 5 <= [60] + 0.5 <= [30] + 1.0 <= [45]
+ 10 <= [110] ++ 1.0 <= [68] ++ 4.0 <= [69]
++ 50 <= [205] +++ 3.0 > [68] +++ 8.0 <= [98]
+++ 250 > [205] ++++ 12.0 > [98]
4. Ketones 5. Protein 6. Nitrite
Change %R for KET. Change %R for PRO. Change %R for NIT.
- neg <= [15] - neg <= [45] - neg <= [10]
± 5 <= [35] ± 10 <= [60] + pos > [10]
+ 10 <= [80] + 30 <= [80]
++ 50 <= [110] ++ 100 <= [130]
+++ 100 > [110] +++ 300 <= [150]
++++ 1000 > [150]
7. Glucose 8. pH 9. S.G.
Change %R for GLU. Change %R for pH Change %R for S.G.
- neg <= [15] 5.0 <= [5] <= 1.005 <= [60]
± 100 <= [80] 5.5 <= [30] 1.010 <= [119]
+ 250 <= [125] 6.0 <= [70] 1.015 <= [179]
++ 500 <= [180] 6.5 <= [125] 1.020 <= [205]
+++ 1000 <= [240] 7.0 <= [175] 1.025 <= [260]
++++ 2000 > [240] 7.5 <= [240] >= 1.030 > [260]
8.0 <= [300]
8.5 <= [330]
9.0 > [330]
10. Leucocyte 11. Vitamin-C
Change %R for LEU. Change %R for VTC.
- neg <= [6] - neg <= [20]
± 10 <= [13] + 10 <= [80]
+ 25 <= [23] ++ 25 <= [105]
++ 75 <= [45] +++ 50 > [105]
+++ 500 > [45]

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YD Diagnostics QA Dept. 34 page DEC.2002 (Rev.00)
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5.5 Initial %R of URiSCAN PRO+ 1.79 ED ROM version (Detail Version)


1 Blood 2 Bilirubin 3 Urobilinogen
- neg <= [20] - neg <= [15] ± norm <= [25]
± 5 <= [60] + 0.5 <= [30] + 1.0 <= [45]
+ 10 <= [110] ++ 1.0 <= [68] ++ 4.0 <= [69]
++ 25 <= [175] +++ 3.0 > [68] +++ 8.0 <= [98]
++ 50 <= [205] ++++ 12.0 > [98]
+++ 150 <= [230]
+++ 250 > [230]
4. Ketones 5. Protein 6. Nitrite
- neg <= [15] - neg <= [45] - neg <= [10]
± 5 <= [35] ± 10 <= [60] + pos > [10]
+ 10 <= [60] ± 25 <= [70]
+ 15 <= [80] + 30 <= [80]
++ 50 <= [110] + 50 <= [95]
+++ 100 <= [120] ++ 75 <= [110]
+++ 150 <= [130] ++ 100 <= [130]
+++ 250 > [130] ++ 150 <= [135]
+++ 200 <= [140]
+++ 300 <= [150]
+++ 500 <= [160]
++++ 1000 > [160]
7. Glucose 8. pH 9. S.G.
- neg <= [8] 5.0 <= [5] <= 1.005 <= [60]
- 25 <= [15] 5.5 <= [30] 1.010 <= [119]
± 50 <= [30] 6.0 <= [70] 1.015 <= [179]
± 100 <= [80] 6.5 <= [125] 1.020 <= [205]
+ 200 <= [110] 7.0 <= [175] 1.025 <= [260]
+ 250 <= [125] 7.5 <= [240] >= 1.030 > [260]
++ 300 <= [140] 8.0 <= [300]
++ 500 <= [180] 8.5 <= [330]
+++ 1000 <= [240] 9.0 > [330]
++++ 2000 > [240]
10. Leucocyte 11. Vitamin-C
- neg <= [6] - neg <= [20]
± 10 <= [13] + 10 <= [80]
+ 25 <= [23] ++ 25 <= [105]
++ 75 <= [45] +++ 50 > [105]
++ 100 <= [60]
+++ 500 <= [60]

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YD Diagnostics QA Dept. 35 page DEC.2002 (Rev.00)
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6. Connection with hyper terminal


on the host computer

6.1 Connect URiSCAN PRO+ with host computer by using RS-232C serial cable.
( Check the com port number of host computer (com1 or com2 …) )

6.2 Run hyper terminal program on the host computer.


① Set port number : Com1 or Com2 ….
② Set baud rate to 9600 (you must make sure that baud rate of hyper
terminal program match up with the baud rate of URiSCAN instrument)

6.3 Set the URiSCAN instrument to “test” mode


- Press ‘999’ from main menu ( see chapter 6 )
- “T” character will be shown left side of clock on the LCD

Preparation procedure is done.

6.4 Setting the instrument

Select 1.mesurement and start test for samples


The result by Hyper terminal program will be shown as below.

6.5 Hyper terminal program window view

Date :Apr-15-2002 16:20:57


ID_NO:0027-
Ward:
Name:
BLD ++ 50 RBC/ul
BIL ++ 1.0 mg/dL
URO +- norm
KET ++ 50 mg/dL <continue to the next page>

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YD Diagnostics QA Dept. 36 page DEC.2002 (Rev.00)
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PRO ++++1000 mg/dL
NIT + pos
GLU ++++2000 mg/dL
p.H 8.0
S.G 1.020
LEU ++ 75 WBC/ul
VTC - neg
Date :Apr-15-2002 16:20:57 ID_NO:0027-
gVTC gLEU rS.G rpH rGLU gNIT rPRO gKET gURO gBIL rBLD
206 343 261 307 365 154 247 363 266 237 261 243
432 274 441 321 278 530 542 238 492 445 459 297
362 382 297 371 356 315 210 398 240 317 278 459
333 388 336 250 561 277 333 423 335 334 340 462
0 6 39 70 283 253 122 184 94 16 61 165

Testing results will be shown and then detailed %R figures will be followed.

Out of above figure, underlined represents calibration data and boxed do %R


figures of each portions.
For example, 165 in the boxed represents %R of Blood and 184 do of protein
portion.

you need to check %R figure as following cases


1. when you adjust sensitivity
2. when you doubt for the result of instrument.

After finishing adjusting of R%, be sure to press “999” to return to normal mode.

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YD Diagnostics QA Dept. 37 page DEC.2002 (Rev.00)
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7. Using Hidden keys

7.1 Adjust H/W(Hard Ware) Mode (“59” mode)

7.1.1 Press “59” from main menu

Adjust H/W

1. Sensor
2. Mover

7.1.2 Select 1. Sensor to adjust sensor sensitivity.


(See Chapter 3.3) Strip IR loading sensor)

Adjust H/W

1. Sensor
2. Mover

Sensitivity : 1000

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YD Diagnostics QA Dept. 38 page DEC.2002 (Rev.00)
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7.1.3 2. Mover menu is consisted of overall system’s moving parts test


(1) Arm motor(Feeder) test : Use left and right direction key
(2) Carrier belt moves step by step (Mecha test) : Press “8” key to start and press
“ESC” key whenever you want to stop the carrier belt.
- This menu will be used when you align carrier sensor (See 4.2.1)
(3) Carrier belt moves for a while : Press “9”key to start
- This menu will be used to check movement of carrier motor.

Test Mover

(<-) back (->) forward (ENT) stop (ESC) exit

(8) Mecha test (9) ALL - go

7.2 Test mode (T, HT, ST, Fm)

Mode Function
* General test mode
T (Test) mode * Check %R by using hyper terminal program
* Check cold lamp figure from LCD
HT (Hyperterminal Test) mode * Check [white] value
ST (Sensor Test) mode * Identify 13 different IR sensor figures
Fm mode * Simulation mode

“27 ESC” (HT) mode

“999” (T) mode “57 ESC” (DT) mode “28 ESC” (ST) mode

“54 ESC” (Fm) mode

* Above figure represents the process to enter each mode to check instrument *

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YD Diagnostics QA Dept. 39 page DEC.2002 (Rev.00)
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7.2.1 HT (Hyperterminal Test) mode

The normal range for [White] (RGB value for check strip) : Approximately 300 ~ 900
This mode is for analyzing %R in detail. Although it is normally possible to read %R in
“T” mode, you can check uncompensated %R value (which is not considered of urine
color) in HT mode by using hyper terminal.

- hyper terminal view -

Calibration:Jul-02-2002 15:23:00 [041-GEN 11][41211]


[WHITE]
1 525 755 349
2 599 827 401
3 628 872 421
4 592 809 396
5 569 776 385
6 577 782 382
7 610 820 408
8 607 810 405
9 616 823 409
10 627 829 415
11 599 792 392
12 451 578 294
320 289 298 397 120 398 315 151 299 314 283 129
344 303 365 268 598 279 349 449 364 348 374 478
335 407 336 333 281 321 335 399 335 337 341 392
443 86 454 98 236 281 470 321 451 461 390 220
52 157 48 292 26 305 50 70 46 56 53 64

gVTC gLEU rS.G rP.H rGLU gNIT rPRO gKET gURO gBIL rBLD
299 300 400 122 400 318 174 302 318 285 142
301 363 266 596 278 347 426 362 346 372 465
399 336 333 281 321 334 399 335 335 342 392 Calibration Data
399 336 250 561 278 334 426 335 335 342 465

-------------------- Calibration is over -----------------------------------------

gVTC gLEU rS.G rP.H rGLU gNIT rPRO gKET gURO gBIL rBLD
320 285 364 313 194 207 313 156 289 315 290 155
346 310 374 317 398 427 446 444 489 348 370 432
334 404 262 370 408 366 241 399 222 336 339 413
496 99 200 130 183 197 387 372 179 554 485 228
45 150 424 162 86 61 473 71 481 54 51 78
Date :Jul-02-2002 15:26:36
ID_NO:0015-
Ward:
Name: %R before compensation
BLD +- 5 RBC/ul
BIL - neg
URO +- norm
KET +++ 100 mg/dL <continue to the next page>

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YD Diagnostics QA Dept. 40 page DEC.2002 (Rev.00)
ISO 9001
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QUALITY SYSTEM

--------------------------------------------------------
PRO - neg
NIT + pos
GLU ++ 500 mg/dL
p.H 7.0
S.G 1.010
LEU +++ 500 WBC/ul
VTC - neg
Date :Jul-02-2002 15:26:36 ID_NO:0015-
gVTC gLEU rS.G rpH rGLU gNIT rPRO gKET gURO gBIL rBLD
320 284 363 312 193 206 312 167 288 314 289 166
346 310 374 317 398 427 446 432 489 348 370 420
334 404 262 370 408 366 241 399 222 336 339 413
333 399 336 250 561 278 334 426 335 335 342 465
0 -5 73 66 163 149 92 -6 113 -1 2 45

%R after compensation (final %R figure)

7.2.2 ST (Sensor Test) mode

This mode is for reading , analyzing and adjusting of IR sensor figure to be used in
recognition of strip. When strip is not placed on the sensing area, the optimal range of IR
sensor figure is between 160~250. When the strip is placed, the sensor recognize the
strip if value of surrounding 2 sensors exceed 1000 in total. (Refer to 4.4 Strip IR loading
sensor) The related sensor figure will be increased by placing the strip on the guide plate
( See arrow mark : the time when the strip has been placed )
< hyper terminal view >

206 187 173 177 166 168 171 205 172 175 182 185 173
206 188 173 177 166 168 171 204 171 192 2553 854 173
207 188 173 177 166 167 171 203 171 772 2757 203 172
208 188 174 177 166 167 171 203 174 1786 1324 191 172
208 189 174 177 166 168 171 203 181 1961 1304 191 172
207 189 173 177 166 167 171 202 183 2287 1010 188 172
207 189 174 177 166 167 171 203 184 2285 1021 188 172

Strip

7.2.3 Check the cold lamp value

Measure the strip dipped in DW in test mode, value of cold lamp is able to check in the
right bottom of LCD (normal range : 200~600). If the value of cold lamp is below
normal range, It is necessary to change entire CCD bracket module to get an optimal
result.

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YD Diagnostics QA Dept. 41 page DEC.2002 (Rev.00)
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8. Trouble Shooting

8.1 Trouble shooting

TROUBLE CAUSES SHOOTINGS


The instrument do a) The connection a) Reconnect the power source.
not work even if part for power b) Replace the fuse and operate the
power source is on. source may be device.
loose. c) Make sure the fuse on the lower part of
AC inlet is in normal condition.
b) The fuse is cut off
due to an impulse
current of
electricity.

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YD Diagnostics QA Dept. 42 page DEC.2002 (Rev.00)
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TROUBLE CAUSES SHOOTINGS

Printing Error a) The thermal paper a) Reload the thermal paper, so that its front
may not be loaded side (the side which is scratched black by
- The test result is correctly. a fingernail) can be open upwards.
not be printed. b) Pull down the lever of printer head.
c) Set the printing environment 'on'.
b) The printer head
- The printed letters may be open d) Checking Step Motor
look dim. upwards - Check Pin 17,18,19 and 20 of U3 by
scope to see if Motor Clock is properly
output.
- Letters are printed c) The printer - Check Pin 3, 6, 11 and 14 of U12 by
partially. setting may be 'off'. scope to see if Motor Clock is properly
- Enter
d) The step motor - Check Pin 2, 7, 9 and 16 of U12 by
does not working. scope to see if Motor Clock is properly
output.
- Check Q5 Base by scope to see if it is
e) The dots on the turned on.
thermal head of the - Check the connecting condition of J8
printer may be - Finally, check any abnormal condition of
damaged partly. Step Motor in Printer Module.

e) Checking Printer Head


- Check Pin 4, 5 and 6 of U3 by Scope to
see if input/output Is properly done
- Check Pin 7,9 and 11 of J10 by Scope to
see if input Is properly done
- Check Q3 to see if PIN 6, 8, 10 and 12
of J10 are connected to Ground.
- Check STROBE of J10 by scope to see if
it is tuned on.
* Check any abnormal condition and trace
up to check and repair front or rear part
which could be abnormal.

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YD Diagnostics QA Dept. 43 page DEC.2002 (Rev.00)
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TROUBLE CAUSES SHOOTINGS
a) The quality of a) Replace test strip by new one and
Test result is too high test strip may be test again.
or low consistently. deteriorated.
b) The current test
b) Check whether testing items and lot
strip and the one
numbers exactly matched and then perform
used for
calibration procedure again.
compensation
may differ in
terms of quality
or lot number.
c) The test strip for c) Use URiTROL to check strip’s condition. If it
compensation turn out to be abnormal, perform testing
may be spoiled again with new strip and distilled water.
or poor distilled
water may be
used.

a) Test strip a) Make calibration again with new strip


The test results are deteriorated by
irregular. moisture or
direct light may
have been used.
b) Remove all the possible factor to prevent
b) The test strip
results.
may have been
- Clean the strip guide plate.
spoiled by other
- Don't use any test strip fallen on the floor.
impeding
- Immerse the test strip fully.
material than the
test strip.
c) Excessive urine c) Remove excessive urine on the soft
may remain on tissue.
test paper.

a) The test strip a) Replace the test strip.


The test paper is may be poor.
jammed at the (bent or larger
measuring point. than specified)
b) The guide plate
b) place guide plate on the accurate position
may have not
again.
been placed on
the accurate
position.

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YD Diagnostics QA Dept. 44 page DEC.2002 (Rev.00)
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TROUBLE CAUSES SHOOTINGS

A/D converter a) A/D converter a-1) Check Pin 2 of U13 by scope to see if
dose not work. error. R, G, B signal is properly input.
a-2) Check Pin 4 of U13 by DVM to see if it
is at 4.096 volt.
a-3) Check Pin 6 of U13 by scope to see the
data output.
a-4) Check Pin 7 of U13 by scope to see if
Chip Select is properly input.
a-5) Check Pin 8 of IC7 by scope to see if
Clock Pulse is properly input.

* Check any abnormal condition and trace up


to check and repair front or rear parts which
could be abnormal.

Letters are a) Check if WA7 of Main Board is correctly


not shown connected.
on the LCD display. b) Check if the front part of V/R1(1.8kΩ) is
at -12Volt ± 0.3.

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8.2 Warning Messages

Warning Message CAUSES SHOOTING

Error Calibration - When the strip is - Try calibration with


contaminated another strip
- When the strip is upside - Try calibration after
down or bent checking the strip’s
- When the strip is out of position.
place - Contact A/S Dept. if the
- When the optical fiber machine is out of order.
module is deteriorated
- When lamp is * Refer to calibration error
deteriorated code

Paper Error - The thermal paper is out of - Check whether the thermal
place printer feeds in place or
not.

No Tray - The waste tray is out of - Replace the waste tray in


place before on during place.
testing

Tray Full - The waste tray reaches its - Empty the strips of waste
capacity, 230 tests. The tray and replace it.
automatic testing stop with
warning sign shown.

Error strip missing - Operator make the - Check missing numbers of


machine stopped during testing and try to test
testing again, be sure to check
- The power is off during patient’s ID and serial NO
testing. before testing.

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YD Diagnostics QA Dept. 46 page DEC.2002 (Rev.00)
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8.3 Service Check List


Trouble Causes Solution
Burned printout Printer head is burned. 1. Replace printer module.
Printer module error 2. Replace mainboard
One area does not be Printer head is broken or 1. Replacing new paper.
printed on paper. contaminated with dust. 2. Clean up printer head
Printer module is out of area with alcohol cotton.
order. 3. Replace printer head
Poor Paper 4. Replace printer module.
5. Replace main board
Printer does not work. Broken or bad connection 1. Replace printer module
of printer sensor wire. 2. Replace mainboard.
Printer module error

ARM motor error 1. Strip Feeder do not 1. Eliminate dust of feeder


moved smoothly. roller.
2. The roller inside of 2. Use WD40 to make it
feeder become hardened. smooth.
3. The feeder has been 3. Push and pull the Feeder
twisted. three or four times.

IR sensor react IR sensor figure in specific Adjust volume resistances


automatically without strip portion shows high on mainboard
on the guide plate (about above 400) (See 4.4)

Strip feeder do not move Strong direct sun-light 1. Install cover to protect
after placing strip on the around the instrument may direct sun-light or other
guide plate. affect malfunction of strip light source. (This cover is
IR loading sensor. supplied by YD on request)
2. Install instrument again
in place far from light. (If
the instrument is placed by
the window, this case is
susceptible to occur)

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YD Diagnostics QA Dept. 47 page DEC.2002 (Rev.00)
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Trouble Causes Solution


Strip is upside down or 1.Contaminated strip guide 1. Clean up guide plate
rebound while measuring. plate. 2. Adjust carrier motor
2.Strip carrier belt cannot 3. Replace Strip holder
move smoothly due to module
malfunction of carrier 4. Change strips
motor (very rare case)
3.Rough surface in the rear
of reagent strip
(very rare case)

reading error 1.Guide plate is out of 1. Replace or change


place. Strip is not on the guide plate.
reading area. 2. see 4.4
2. IR sensor reacts
automatically without
strip on the guide plate.

Printing only Items without 1.Poor Strip stabilizer. 1. Retry measuring the
any testing result 2.High level of hematuria or sample
Fluorescence urine. 2. Replace CCD bracket or
(Normally, it occurs in the make strip stabilizer to be
first data after standby) smooth with WD40

One or more portions result Optical fiber is broken 1. Replace optical fiber
fluctuate suddenly. module.
2. Replace CCD bracket.
.
Retry calibration Power failure to Cold lamp. 1. Check the power
Malfunction of mainboard connector of CCD bracket.
or ROM. 2. Replace ROM
3. Replace mainboard.
Interface error of PRO+ Weak output signal of 1. Replace new SMPS.
SMPS

The strip carrier belt moves Carrier sensor do not Check the contamination of
two consecutive times recognize pin of belt carrier sensor or change
(missing data) it into new one.

Improper contact of rake to Strip feeder has been 1. Lift the Strip feeder
the guide plate. twisted by long term use. upward purposely.
2. Cut out the contact area
of rake.

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YD Diagnostics QA Dept. 48 page DEC.2002 (Rev.00)
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8.4 Calibration Error Code

8.4.1 Calibration Strip Error


- Optical fibers are broken or contaminated with dirt. Ask for Service Dept.
10-01 Compensation
10-02 Ascorbic acid
10-03 Leucocytes
10-04 S.G
10-05 pH
10-06 Glucose
10-07 Nitrite
10-08 Protein
10-09 Ketones
10-10 Urobilinogen
10-11 Bilirubin
10-12 Blood

8.4.2 No Strip Error


- Strip is not detected. Retry Calibration
10-15 No Calibration Strip
10-16 No D.W Strip

8.4.3 D.W Strip Error


- You might have used other materials as Saline, Water, Urine ect. Or D.W could be
contaminated. Retry calibration with clean Distilled Water.
- Strip may have discolored. Check the Base color of Strip pad.
10-22 Ascorbic acid
10-23 Leucocytes
10-24 S.G
10-25 pH
10-26 Glucose
10-27 Nitrite
10-28 Protein
10-29 Ketones
10-30 Urobilinogen
10-31 Bilirubin
10-32 Blood

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9. A n n e x

9.1 Comparison Specification of Urine Instrument

URiSCAN PRO+ Clinitek 200+ Miditron M


Boehringer
1. Manufacturer YD Electronics Bayer
Mannheim
2. Formation Desk Top Desk Top Desk Top
3. Demension(mm) 465(W)X440(D)X246(H) 356(W)X495(D)X218(H) 480(W)X480(D)X310(H)

4. Weight 7 kg 15 kg 15 kg

5. Voltage 115V(50/60Hz) AC 120V(50/60Hz)


85V~250V(50/60Hz)
Power
6. 80VA 120VA 130VA
Consumption
Storage /
7. Operating 0~40℃/20~28℃ 18~30℃/22~26℃ 15~34℃/22~26℃
Temperature
Storage /
8. Operating 10~85%/10~70% 20~85% 15~34%/22~26%
Humidity
9. Principle Reflectance Reflectance Reflectance
10 Light Source Cold Lamp Halogen Lamp LED
Light Source
11 20,000 hours 2,000 hours Semipermanent
Shelf Life
Light Wave 440nm,540nm,610n 555nm,620nm,660n
12
length m m
Strip used YD strip 12Items Multistix Combur 10 Test M
13
(parameters) (4 ~11parameters) (8 ~10 parameters) ( 10 fixed)
14 Throughput 360tests/1hour 360tests/1hour 300tests/1hour
Measurement
15 10 sec. 10 sec. 12 sec.
Cycle
Memory
16 2,000 tests 250 tests 300 tests
Capacity
17 Interface RS232C RS232C RS232C
LCD / 8 lines
18 Display Result and Menu LCD / 2 lines LCD / 2 lines
Display
Auto
19 Yes No Yes
Compensation
20 Auto Check Yes Yes Yes
Print (useful for
21 Calibration data No Print
Quality control)
Abnormal data & list
Abnormal data
22 print Abnormal data only Abnormal list only
Print

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YD Diagnostics QA Dept. 50 page DEC.2002 (Rev.00)
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URiSCAN PRO Clinitek 200+ Miditron M


Concentration &
Grade Result Concentration Result Concentration &
( R% range, Grade Result
23 Result Print
parameter, result ( R% range Setting ( Range, parameter
and shadow print Available) Setting Available)
Setting available)

URiSCAN
Clinitek 50 Urilux S
Optima+
Boehringer
24 Manufacturer YD Electronics Bayer
Mannheim
25 Formation Desk Top Desk Top Desk Top
330(W)X327(D)X167( 152(W)X234(D)X153 180(W)X275(D)X100
26 Demention(mm)
H) (H) (H)
27 Weight 3.65 kg 1.7 kg 1.6 kg
230V/50Hz or
28 Voltage 85V~250V(50/60Hz) 115V(50/60Hz)
120V/60Hz
Storage /
29 Operating 0~40℃/20~28℃ 18~30℃/22~26℃ 15~32℃/22~26℃
Temperature
Storage /
30 Operating 10~85%/10~70% 20~85% 20~80%/22~26%
Humidity
31 Principle Reflectance Reflectance Reflectance

32 Light Source Cold Lamp Halogen Lamp LED


Light Source
33 20,000 hours 2,000 hours Semi-permanent
Shelf Life
Light Wave 565nm,610nm,660n
34 440nm,540nm,610nm
length m
Strip used YD strip 12Items Multistix 10 SG Combur 10 Test UX
35
(parameters) (4 ~11parameters) ( 10 fixed ) ( 10 fixed)
60tests or
36 Throughput 60 tests/hour 50 to 120 tests/hour
300tests/hour
Routine test mode :
Measurement 100 sec.
37 60 sec. 70 sec / 30 sec.
Cycle Quick test mode :
6sec
Memory
38 2,000 tests 50 tests 100 tests
Capacity
39 Interface RS232C RS232C RS232C
LCD / 8 lines
40 Display Result and Menu LCD / 2 lines LCD / 2 lines
Display
Auto
41 Yes No Yes
Compensation

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YD Diagnostics QA Dept. 51 page DEC.2002 (Rev.00)
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URiSCAN Optima Clinitek 50 Urilux S

42 Auto Check Yes Yes Yes


Print (useful for
43 Calibration data No Print
Quality control)
Abnormal data Abnormal data & list
44 Abnormal data only Abnormal list only
Print print
Quantitative &
Qualitative Result Quantitative & Quantitative &
( R% range, Qualitative Result Qualitative Result
45 Result Print
parameter, result ( R% range Setting ( Range, parameter
and shadow print Available) Setting Available)
Setting available)

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YD Diagnostics QA Dept. 52 page DEC.2002 (Rev.00)

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