SINNOWA@

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Sinnowa Medical Science & Technology Co.

Ltd

Table of Contents

1.1

1.2 1.3 1.4

6 TEST

-1-

7 PATIENT INFORMATION.

.........29

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1 lntroduction

1.1 Main Features

The features of the filters are shown in table
Table
1
:

Feature Wavelength Accu racy ( nm )

Technical Parameter

t2.0
<10 >35
.

Half-Width ( nm ) Transmission Peak Ratio (%)

-O.D. Accuracy:< t0.01A or 1%

Linearity: r>0.999

-O.D. Reproducibility:<0.5% -O.D. Stability:Drift Error<0.005A in 1Omins;

.

Drift Error<0.005A when the supply

voltage swings t10%

1,2 Specifications
-Graphical operating interface, menu designed for convenient use.

-500

programmable analysis items. wavelength/Fixed

Four measure method : Single wavelength/Dual

time/Kinetics.

-Eleven analysis means, ABS / Cut-Off / Single point regression

regression

ABs%/Exponential

/ Regresssion /

Multipoint regression

Linear

Logarithm Regression

Dual

Logarithm Regression

/ Logit Regression /

Polynomial Regression.

- Performing 12 different tests just in one plate. Flexible Plate Position with
Blanks,Reference,standards.Samples and QC in one screen.

channels optical fiber scanning, auto plate centering system positions the center of the cell accurately.Get reading result in just 10 seconds.

Proven optical system with

- Printing patient reports with the thermal printer. - Easy connect to PC,comprehensive functions with PC software.
1.3 External Features
Top View as figure 1:

h,

Figure I

Power indicator light

@ LCO and Touch screen

Figure 2

O Power ON/OFF

switch

@ Power cord receptacle @ Fuses @ Gemel @ RS-232 serial interface @ Parallel printer interface @ USB interface @ PS/2 mouse and keyboard interface @ Serial Number Label

-2-

k,

1.4 Specifications
Weight: Outline Dimension:
AC(220L22)V

460mm

(L)

x360mm

(W) x21Omm (H)

(50t1)Hz

F2AL250V 2-9Sx20 mm

Temperature:
Storage temperature: Light Source: Wavelength: lndication r3flge:

*s-+.40c; Rerative humidity

: 2}o/o-gooil; Atmospheric

pressure: 860-1060hPa

-10c-50c
Tungsten Halogen Lamp, OSRAM64607, BV/SOW 405nm, 450nm 4g2nm, 630nm

Continuous mode<10s, Stepping mode<20s

ARM core series

Programmabl

e ltems:
lnterface: Display:

320x240 LCD

"r'.

usB.. Mouse and keyboard interface

lnput Mode,
Memory Capability:

Touch Screen ,Touch pen 2000 Plates ( 96 holes ) test data

2 lnstrument Set-up
2.1 lnitial Start-up

the instrument in a ctean, relatively dust free environment to

maximum performance.

Place the instrument on a clean, sturdy table or bench.lt is important to keep ensure

-3-

Connect the power cord to the back of the instrument.Before connecting the

instrument

to the main

electrical supply, check that the AC voltage is

appropriate for the instrument.

3 lnput operation
3.1 Touch Screen and Pen
ln the Microplate Reader, the pen is used to click on the area of the visual screen. The valid method of input operation is the single click, which means to
touch the screen by the pen or the finger and then to remove immediately.

3.2 Digit soft keyboard

!t is used to input the integer (like the time,date)and the decimal fraction(like

the concentration) as Figure 3.

Pletse inFlt Lll[ cEutra=t res - I5

trtrtrr trtrtrr trtrtr8

trtrtr8
Figure 3

3.3 Gharacter soft keYboard

Keybord is shown as Figure 4. lt is used to input the character string. The "<-" key is used to delete the character, and the "CAP" key is used to shift the
uppercase and the lowercase of the character.
FLease input l:,:spltal t:alte Hax. tenrtlr :rrJ

Flease irrput hnspittl llax. LEngth f,

r:aue

EtrtrtrtrEitrtrEltrEltrtrtr

Etrtrtrtrtrtrtrtrtrtrtrtr Etrtrtrtrtr_trElIl_trEgtr ffitrtrtrtrtr@ Etrtrsssstrtrtrtrtr l=,,-ltrtrtrtrtrtrtrtrtrtr I il,1- ]trtrtrfltr@trEtrtr EEtrl-l@@tI fqmn-l-l@@tE

Figure 4

tEE-EEtrtrtrtrtrtrtrgt]_trtrtrtr

-4-

3.4 Date/time soft keyboard

It is used to input the date and the time as Figure S. The format
Year-Month-Day and the "Today" is used to input the date of today quickly.

is

trtrtrE trl-r_", lffi

Figure 5

trtrtrr trtrtrEq

PLease input drte 2000-rl1-rl1

309S_12_3I

3.5 Formula soft keyboard

It is used to input the formuta as figure 6. There are four N(Negative).. four P(Positive)'. eight D(Standard).. MIN(get the minimum value).. MAX(get
the maximum value) and the common operators.
Ilax. Iengrh
Please 1r:put torluta
S0
L

i
l

EEEEEEEE@ EEEEEEEE
I * I lil-*l fofr-l IFI
Figure 6

EEEEEE4ETE@

4 Start-up
4.1 Procedure of start-up
Turn on the power switch on the rear panel. After about three seconds, the instrument will perform an initial self diagnosis that requires about one minute.

Please wait ten minutes for the instrument

equilibrium)before reading plates.

to warm up(reach

thermal

1)

The procedure of start-up inctudes: Load the program;

-5-

2). Access the user data;

3)

Wait for the stable light of the Iamp. It is necessary to wait about five minutes

for the stabilization of the lamp before the first reading. (The result of O.D.
may be not accurate if the lamp is not stable. )

4)

Self diagnosis of the optical and the mechanical system .The filter wheel will
turn around and the plate will reciprocate once.

4,2 Main Menu

The screen displays the main menu after the procedure of start-up. The main

menu has six different modes: Patient lnformation, Test, Report, System, ltem
Setup and Search as Figure 7.

I-F\

u
atient Info

IE
Test

JB lEl
Feport

tr
5 ltem Setup

--:-= E

SYste

w
Iten
Iteu
I,EDe

H,q
Search

Setup

Figure 7

Choose the ltem setting con in the main menu and go window as Figure 8:
]D

the item

I
Z

IlBsAg

IlEslb
HtseAg

3 4 5

IlBelb
IlEch

FuII I,laue iepatitis B lepEtitis E lepatitis E lEp8titiE E lep8titis E

anEIYS].E

Eut-0ff

Eut-0ft

[ut-0ff f,ut-0ff
Cut-0ff

Page Up Page Dorln

ller

llodifl DeIete Feturn

Figure 8

The user could set 500 different items at most.

5,1 Measure method

The reader has four measure methods.

-6-

&

5.1.1 Single wavelength

The method uses one wavelength to measure the oD.

5.1.2 Dual wavelength

The method uses two wavelengths to measure the OD. The result of OD is the difference of the main wavelength and the reference wavelength.

5.1.3 Fixed time

A first absorbance measurement is

made for each sample after

programmed incubation period, and a second measurement performed is after a defined interval. The fixed time method should use the single regression analysis method.

5.1,4 Kinetics

A first measurement of absorbance is made against the BLANK after a

programmed incubation period. Next, new measurements are made at defined intervals of time. The absorbance is calculated as the mean of the increase (or decrease) in absorbance per minute. The kinetics method should use only one wavelength.

5.2 Analysis method

and quantitative data-evaluation functions with cut-offs, curve-fits

tra

There are eleven analysis methods, including the comprehensive qualitative

and

nsformation form u las.

5.2.1 O.D. mode

Measure the O.D. of the plate cell direcfly.

5.2.2 Qualitative(Gut-Off) mode cut-off limit formula z cov = x x NC +y x pc + Fac NC is the O.D. of the negative reference materiat, PC is the O.D. of the positive reference material,X,Y, Fac is the coefficient, which is set in the reagent
instruction.All the other kind of qualitative formula can convert into this formula format.For example: if sample oD/Negative Ref.oD>2.1 is the positive,then
X=2.1

, Y=0, Fac=O.

The ratio of the sample O.D. and the Cov is often used to define the
qualitative result,and the unit is s/co.The normal s/co threshold is 1.

5.2,3 Quantitative mode

1)

Single point regression mode: ore standard needed, use the origin and the
n t-

standard O.D. to fit the curve as Figure

9. (X:concentrate, Y:O.D.)

Figure9

2) Multi point regression: Two to eight standards needed, use all the standards O.D. to fit the curve as Figure 10:

Figure

l0

lf the curve is not

Figure
11
:

monotony(increase

or decrease),the result is error as

o.D.

Figure l1 3)

Linear regression: Two to eight standards needed, use these standards to fit

the regression curve

as Y = kX + in Figure 12:
o.D.

Figure 12

-8-

4)
5) 6)

Exponential Regression : Two to eight standards needed , use these standards to fit the regression curye as y kebx,all the standard O.D. must =
be positive number. Logarithm Regression' Two to eight standards needed, use these standards to fit the regression curye as Y -kLnx+b,all the standard O.D. must be positive number.

must be positive number. lf setting the

x' = Lnx ,Y' = Lny,then

Dual Logarithm Regression, Two to eight standards needed, use these standards to fit the regression curve as y:lg$Lnx+b),all the standard
O.D.

concentration

as

7)

concentrateofthestan,:::";:',,?",tl;m';:il:::,Hi:,"
B)

the regression formula turns to y, _ k,x,+b, . log-logit Regression: Two to eight standards needed, use these standards to fit the regression curve as Log-Logit method. The_ abscissa of Log-logit curve oD ^ is Concentrate, the ordinate is -!-

Polynomial Regression, Two to eight standards needed, use these standards to fit the regression curye as Y kxb, all the standard o.D. must be positive number.

5.3 Add New ltem

choose the ltem setup icon in the main menu and go into the item list
window as Figure 13.
ftel rrane
Fr-lt- llsnre
tlTl,lL

l-.Trr.rr

Feagerrt l@-rrrll:tai,'ra'elength rEsr I,re1:Iro,:fEffiEl l.I.rTEl

Arrar-s=is

lffiTTiEEEl
ff tlnluun
I'ro.

S :iirJ'1e Salr f,, D,:trhte

Ersnl: Ilu*.|ffi|

rir:u::

:irr

Fer. rrealffitrl

l..Tl
I

r..-*

I f- ,-,,, I I E*

- Iffil

Figure 13

Select"New"key to add new item. The parameter of the item setup:

ltem name: ltem brief name, string including twenty characters at most, blank unallowed;

-9-

o o . o o .

Full name: ltem full name, string including thirty characters at most, blank
Reagent: Reagent name, string including twenty characters at most, blank
Test Method: Select the test method from the four methods.

allowed.

allowed.

Main/Second Wavelength: select from the wavelength

list, and the second

wavelength should be different with the main wavelength;

Analysis: Analysis method, selected from the list of methods.

Single Sam/Double Sam/Column minus: the type of the sample, the default

setting is single sample, the double sample means double sample for each
patient, the column minus method is a specific method, which uses the second column minus the first column as the sample value.

Blank Max.' Define the max. value of the reagent blank.For example,the

reagent needs the blank less than 0.05,then the upper blank must be 0.05.1f the blank O.D. is larger than the upper blank, "Too Iarge OD blank"will appear and the maximum blank is used as the blank automaticly.

o o

Sort No.: Define the sort of the item in the patient report. The small No. is in Ref. Area: set the normal area of the item.The area is used in the report

the front of the list. The default value is 100.

only.The area value don't take part in the formula calculating. The default value

of the area is 0.000

0.000

0.000, and the column will not print

if the area is

. o o .

0.000.

Analysis Means: choose the analysis means from the list.According to the
Wait

different means, the screen will appear different windows.

time: used in the Fixed time method and Kinetics method, the range of
times: Used in the Kinetics method, the range of the value is 2 to 10.

the value is 10 to 120;

Test
If the analysis method is Cut-Off, click "Next" to view the menu as Figure 14:

Negative/Positive Ref Area' The valid reference area of the Negative and

Positive, the default value is 0.000-4.000; o Negative/Positive 1-4: User can see the OD of the Negative/Positive after
test, or set the OD directly without test.

-10-

I,Jerrtlue Fef

Ire

tr.trpl
f nrrtr |
Iiegative I
I'IEgEI:iTJE
T

Pnsitire Fef Area

ffi

lresari,e F,rsirirE

trEI

l4Jrtrl

trEI

trEl
l_

I r.ltr | | rrstl
lr-rrrtrl

Iffil

Fositl',:e
I

IJegatirre

lr

Iffit
|
r,tr

l'trrxrtr

Psitire Pnsitire
Fr:sitir,'e

f, 4

. orrr

I,legatilre

lP=*j",,=l

f*E [
Figure 14

I-ffi| ,- If E*

Click "Next": Qualitative Group Name, User can define the name or signal of every group; Click the label "Group 1"-"Group 5" to set the predefined name, which will shift between the "Negative,Weak negative,Neutral,Weak positive,positive,,; Formula(Cut-Off value): User can define the C.O. formula or value of every group, four formulas at most;

The relation of the Cut-Off value.. OD value and qualitative is as Figure 15:

l+
Cut-Off value
Figure 15 OD

From the manual of the ELSA kt, the formula of the cut off is ,,cut off value=Negatve x 2.1" , so the formula should be 2.1.NC1 ; lf there are comments like"Minimum Negative OD = 0.05 ", the meaning of the comments is to get the large value of the NC1 and 0.05, so the final c.o. formula is: 2.1.MAX(NC1 ,0.05)

This is the formula of the Group 1 . There are four formutas at all. And the value of the formula must be "Form ula 4 >Formula 3> Formula 2> Formula
1,
.

The five groups have four formulas.

lf the item has more formulas, the CO vatue in S/CO could be selected from the four formulas. The default vatue is 1 .
lf the formula is longer than the viewing area, just click the formula before the group label to show the full formula in the last line as Figure
16.

llr.af

itative

lroup
.2+1II+FI

llGiIll+lffil
l'iiE'?Il+

FnruuLa

L'irrrup Erc,ur

I-l

i[-l+ Group 4l-l',

rirnup

l-l I-l
tnrrr'1e

rl-l

u= f, rralue Select the f'lru1u[ llllclr fsrlu1a 1he1 trErI dispra'j th':'Le

fp.",,i",-l

t n-* I

I I E=" I

Figure 16

lf the anayss method is quantitative method, click "Next" to view the menu:

o . o o .

STD numbers: define the numbers of the STD.

Dilute Multiple' define the dilute multiple of the sample, and the calculated
Unit: Choose unit from the 24 common units in the list.

value should multiply the dilute multiple.

Dual STD:

lf

check the dual STD,all the standards in the plate will be

positioned double times.

+"100/o as the ordinate of the ABS percent: check the box to use "D^ standard graph, the D0 is the reference stadard of 100% O.D., and the D0 needs no concentrate. lf the item seects the ABS percent, the first standard is
D0 when position the plate. The dual Iogarithm regression cannot use the ABS
percent because of the ordinate is in logarithm.

. .

STD concentrate table: Display and select the STD concentrate. Attention:
Modify concentration: Modify the selected concentraton as Figure 17.
sTD

AII the STD concentrate should increase.

uuu

ft

ID

Ilncerrtration I. tltltl
z. tltltl
3.
t-il:il:l
r_il_r L-l

f,,i1r.te I,lr-r1tip1e
Uni-t

Z,

4.

r:r.rrl

5TD

5. IUr]

[.+rs
Hod

Percent:

j-t1 llsncenl:ration

,5TD

f,oncentratiun shor.lld increast

I

lp'-,j--llil.=*l n- IIB*
Figure 17

Click "Next" to set the qualitative group and formula as the Cut-Off item.

Click "Next" to set the Quality Control. The menu of QC is demonstrated in the

-12-

next secton.

After setting all the parameters, click "OK" to save the item. Attention: The same name of the item is not allowed.

5.4 Quality Gontrol Settting

The qualitative and quantitative items both could set two eC materials as Figure 18.
@uc r
Earch

Enc
X5Il

r,r".lffi'l

Eatch lo. O L-J

[:ffi|
SD

QHnoron

fi t-'I

QHnorrrr H_

ff fnstart neans 0 lrrstBnt nJEans ruerase f r-l Ilodify 5I Tabte

plttutti-ruree

lP.*i",,=l

I *
Figure l8

l,]rrIt1-r l"es

I E="-l

o Average: The average value of the ec materials(F); o sD' The standard deviation of the ec materials (.gD). The routine quality control in room includes the routine conditions
(RCVU).
For RCVK, select"Known of the QC materials.

Batch No.: The batch number of the QC materials, different batch QC materials should have different eC data;

variance-knownvalues ( RCVK) and routine conditions variance-unknown values

7.

SD", ohd input

the

and 5D

in the manual

For RCVU, select L-J or instant means. The Levey-Jennings rule uses the front 20 values to calculate 7 . SD, and makes the eC graph from the 21rt value. The instant means uses the Sl table, calculates x.,sD and makes the eC graph from the 3'd value.

The limit of all these QC methods is i tzs. with the development of the computer, there are more and more efficient control methods. The instrument integrates a common multi-rules control method: westgard Mutti-rules. Here is the routine of westgard Multi-rules as Figure 1g:

-13-

B
t

ffir

In control

:l'

I, t,
Out

I, I, I,
of control
Figure 19

5.5 Modfy the item

Select an item from the list and click the "Modify" key to modify the item
setting.

The Cut-Off value will be cleared if the Cut-Off item is modified.

The quantitative curve and the STD concentrate will be cleared f the
quantitative item is modified.

5.6 Delete the item

Select an item from the list and click the "Delete" key to delete the item. lf the

"ok" key in the confirm window is clicked,the item will be delete completely.lf the
"Cancel" key in the confirm window is clicked,the deleting will be cancelled.

6 Test
6.1 Test setting
Click the Test icon in the main menu and go into the plate reading
mode.select the parameter from the window to modify the setting as Figure 20.
It""d s.-""ilI
Sterltri]. PIte
HDe:

IE="J.=rr-i1

SetrI] DiEectiorr QIIorizonta]I{ovj-rq Hode Q Corrtinuous shkirg Hode sharr:.net s:eed ls]", -E 5hk:-rrg Tiue l s=*o"d E

OVerti,=EI Q Steppj-ng

I * I I "="1
Figure20

-14-

Moving Mode: select the plate continuous moving or stepping moving; Shaking speed: select the slow., medium or fast shaking speed; Shaking time: select the time of shaking plate, user-defined area is from 10 to 180 second.

o o o ' o

Load stencil: toad the preset stencil of position; Plate Direction: serect Horizontar or Verticar position;

6.2 Plate Hole

Table 3
!

10

11

A
B

12

A1
B1

A2

A3
B3 C3 D3
E3 F3

A4
B4

A5
B5 C5 D5 E5
F5

A6
B6

A7

A8
B8
CB DB EB

A9
B9 C9 D9 E9
F9

410
810

All
811

412
H^12

82

87

C
D
E

c1
D1 E1
F1

c2
D2
E2 F2

C4
D4 E4 F4

C6
D6 E6 F6

c7
D7 E7 F7 G7 H7
(_-

c10
D10 E10 F10 G10 H10

c11
D11 E11 F11 G11 H11

c12
D12 E12 F12 G12 H12

F G

F8
GB

G1

G2 H2

G3 H3

G4
H4

G5 H5

G6
H6

G9
H9

iH1

H8
o

The direction of the plate,s moving is

6.3 Stencl
Click the "Load Stencil" Button to go to the Plate Load tnterface as Figur e 21 .
P.l-Ei:E LoEd

III

5tr=I.I':i1

t:

el

Hrile

-".r" ,r,

I --.1
Figure 21

I-l

F*-

t,-,;l

6.4 Hole Position

select an available stencil in the list and click ok to toad the position of the stencil' All informations including the direction, moving mode, shaking speed, shaking time, the item and the type of each hole are stored in
the stencit.

(N, p), standard(D),Quality control(oc) in any hole of the standard 96 holes plate as Figure 22.

User can position the sampre(s), Brank(B), Reference

-15-

I , l ' lt ll F ll , lt * llr-r*rl rteu rst :FI arl f eno rrd 4rh

<+
Z
I'11

FJ

! Itl ]I

la

E
D

PI

gI

JJ

JD

EO

E
F
L-l

l,.*l ls.-"-i{@ tiil IffiI

Figure 22

f,urrent op: f,

Itero I,leue:

HEsAg

The procedure of the position:

a) b)
d)

Click "ltem" to select the item; Click "S,B,N,P,D,QC" to select the type of the sample;

c) CIick the hole on the screen to position;

When multi-items position, after finishing the 1't item, click the "2nd,3'd,4tn" to select the other item. CIick the ">>"if position the Sth
-12th item. After changing the item, the positioned hole will be dark.
;

- Sample
User could click any hole to set the Sample.CIick the hole again to modify the Sample No.The area of the Sample No. is from 1 to gg9.

Blank

The blank is used to do zero adjustment.lt means that all the other hole's OD

should minus the Blank OD.lf the BIank is not positioned, the default blank
zero.

is

Every item can position more than one blank holes.lf there are several blank holes in the item, the result only displays a mean blank value.

Negative Reference

The negative reference is valid only in the Cut-Off items.User can position

the negative reference or positive

reference according

to the Cut-Off

formula.Every item can position more references. lf there are several Ref. holes
in the item, the result only displays a mean Ref. value.

The values of the Ref are saved automaticly.lf the next test of the item
doesn't position the reference, the program will use the saved reference value.

- Positive Reference
Positive Reference is set as same as Negative Reference.

16

l.

- Standard
The Standard is valid only in the quantitative items.The user should position all the standards before reading the plate.lf the item has the saved standards,it is
not necessary to position the standards.

-Quality Control
Valid if the item has QC.

- Clear
User can click the hole to clear after select the "Clear" button. And only the hole of the current item can be cleared.

- Stencil
The Stencil button is used to save the positioned holes as a stenci!. Click "Stencil" after finishing the position to go to the stencil operation interface. Input the name of the new stencil and click "Add" to save the stencil. Click "Modify" or "Delete" button to modify or delete the selected stencil. Load Stencil function is in
the first interface of the test.

Batch

Click "Batch" to enter the menu of batch position. Only the sample can be batch positioned. Select the Sample No., Start hole and the number of the sample to finish the batch position.
The ways to position the hole:

o o o o

Click the hole to set a hole;

click the number

(1-1 to set a column of holes;

(A-H)
to set a line of holes;

Click the alphabet

Click the "*" to set all the holes.

All the ways is valid to Clear operation.

6.5 Plate test

After all the settings, click "Ok" to move the plate and read the absorbance automaticly. The first time of the test needs some minutes to stablizate the light source as Figure 23.

-t7-

iE sttrhlE Te=t 45 IJavelength Setting f iIl:er

The liqht

I
6.6 Result view and print

-..*-l
Figure 23

After the plate reading, click the "Position" to view the position of the plate. CIick the "ABS" to view the value of absorbance. CIick the sample hole to modify the value.Attention: lf the value is Iarger than 4.000A,the value will

display as 4.00*;lf the value is less than 0.000A,the value will display as
0.00*. Click "Qualitative" to view the qualitative of the result according to the setting of the item.

Click "Quantitative" to view the calculated value. In the Cut-Off item, the quantitative value is the value of S/CO. But in the quantitative item, the value is
the calculated concentration.
CIick "standard" to view the standard curve.

The default setting is to show the result of all the itenns. If only one item is wanted, just click the Num or >> to shift the item . Click AII to view all the items.
CIick "Save" to save all the values of the plate. The memory of the instrument can save more than two thousand plates.

Click "Print"

to print all the values by the

PIEre l,lo. :3 {{ II t

position. The holes that not

positioned will be neglected automaticly as Figure 24.

}} 11 Lsr End 3rd 4th
4 .5.
5

U. UU5
U. UI4I

I
D

E
F
G

U. UIJ U. UUtr

U. UUU U. UUU U. UUU U. UUU

U. U9tr U. U9ts

q.

. UJtJ u. .)5tf u. 554 I. UJ! . UJ9

UU

tt_ ltq

U. U9U

T. UqU

$ Position
IAEs

Sare I Print
Page Dounl Standard

$ tluantitatiue Q Qualitative

lFeturn

Figure 24

-18-

7 Patient lnformation
Click the "Patient lnfo" icon in the main menu to enter the setting of the patient information as Figure 25.
Fatirnt Inf
ll 5
l,ln.
ll a: e

Test Ilete

Feter

I--l
| ,,r'.,
| '"-- ,,, I F"'= ,-,;l
I

I --..=l I t-.-rl
Figure 25

7.1 Summariz.ation
Select the Test Date to view the list of the samptes. The default sending date is the current date.
There are two modes of filling the information:

+ +

First set the patient information:

Click the'Add'key to set the patient information, and the first column flag 1, show that the patient's information is finished already. First test the sample:

After finishing the sample test, the first column flag o show that the tested sample has no patient information. Select the o row and click 'Modify, to input the patient information. The meaning of the flag in the first column:

a o r

Patient information existed, but no sample test result. sample test result existed, but no patient information.

Both the patient information and the sample test result existed. lf the patient information and the sample test result both exist, click ,Modify,

to modify the patient information.

lf the added sample number already exists in the test result, the system will
automaticly combine the two contents. Click the Delete to delete the selected patient's information and test results.
7

.2 lnformation records
The patient information can be added or modified in the patient info menu or

-19-

in the patient searching menu.

Sample NO.: Every patient has one and only sample number in one day. The sample number cannot be changed when modifying;

Name: 18 characters at most;

Sex: Select from Male, Female and unknown; Age: the area of age is from 0 to 150; Bed No.: 9 characters at most; g Record No.: the record number in hospital, characters at most; sample: the type of sample, defined in the word book; Department: the sending department, defined in the word book; Sender' the sending doctor, defined in the word book; Laboratory: the clinical laboratory, defined in the word book; Analyzer: the analyzing doctor, defined in the word book; Send date: the date sending the sample, defined in the word book; Test date: the date testing the sample, defined in the word book. Click OK to confirm the input, Esc to cancel the input as Figure 26.
Sample N0. llaue 5ex
Age

SaupIe

l-t"=l
lH"r.

Dep.Etloent
Sender

liEEffiEE

f-pl
Io.

t-t

LEborEtorl

Eed l,lo.

Fecord

t-l t-l

It"b'*t"EI

Inalyzer
Sead DEte

t--

lffirl
2007-03-09

ffitE
8 System Setting
Figure 27.

Test date

Figure 26

Click,system'icon in the main menu and go into the system setting menu.
There are four functions: System set, System log, Data delete and Word Book as

-20-

E EE EE E ffi
Figure 27

SIEtenl

8.1 System setting

Select the 'System set' key and go into the system setting menu as Figure seriar r,ro. ( rD I reua:-rlrll 28:
HDsIritEI
I,lame

FelrEt Tj.tte

Dare

rire

I trrr.-o"-r6l IEI
lE"qli=h
ITIr,==r"I -E

Lar:guage Fri-nteE LrlD trtrnrrasr Iil,:rk Hode

Hai-rrter-leRce

EI=lE 15r""cl.-"1"",=E
Touch Defar-r-lt
oh

CanceI

Figure 28

1) Serial No. ( ID) : Show the

modified;

identifier of the instrument, not allowed

2) Hospital Name: The name will appear on top of the patient report; 3) Report Title: The name wll appear following the Hospital Name;

D Date: Set the date of the system;

5)
Time: Set the time of the system; 6)Language:System supports Chinese and English;

Such as changng the language option, you need to press "OK'' button to restart the instrument to take effect; The Date and Time is used in the test and report, please adjust the date and the time before usng the instrument.
7

) Printer: Show the type of the printer, the default printer is the internal

thermal printer. The internal thermal printer has three keys: OPEN key is pressed to open the door for adding the thermal paper (Attention: The outer side of the
paper is the thermal layer. The thermal layer must touch the thermal head.); SEL key is red when online, LF key is green when the power is on. Press SEL to turn

-2t-

off the red Iamp and press LF to send the paper. Turn on the power
pressing the SEL, and then loose the key to do the self-test;

8) LCD contrast: Used to adjust the brightness of the LCD back light; 9) Work mode: Select the stand-alone mode orthe PC control mode.
Attention: Before using the PC software, please choose the 'PC control' mode. The 'Sample test' key will disappear in the PC control mode, and the
program should be in the main menu when using the PC software.

10) Maintenance: Some maintaining and calibrating functions;

11) Touch: Used to calibrate the touch screen. The touch screen is already
calibrated before leaving factory, so do the calibration only when necessary. The use of the calibration: Firstly calibrate the abscissa K: CIick the left part of the screen, the screen
wil! display the real pixel point, then click the right part of the screen, there will be

a pixel point also, if the horizon distance between the two points is longer than the two clicks, decrease the abscissa K, othenryise increase the abscissa K.
Adjust the K until the distance is the same. Secondly calibrate the abscissa B:

CIick anywhere on the screen, if the displayed pixel point is not in the same
position of the click, adjust abscissa B until the abscissa of the click is accurately.

The calibration of the coordinate is the same as the abscissa. After finished the
calibration, click OK to save and ESC to quit.

12) Default: Restore to the leaving factory state, and all the user's input will
be deleted. The initial setting includes 23 test items and some common words. But the setup in the System Config will be remained including the calibration of
the touch screen and the setup of the filters.

Click OK to save the new setting, otheruvise the new setting will disappear
after shut down.
djust lhscissa
Abscissa
J,hscissa

Idjust

rdinate

@l @l @ @

r. trrl

rJrdinate Drdinate

I.
-Z

E E E E
0k

EIear

Default

Esc

Figure 29

Click the 'Maintenance' key to go into the system maintenance menu as

_ZZ_

Figure 29. The maintaining module consists of four functions: Add new filters, testing the new lamp, verify the repeatability and advanced function. o Filters Setup: The start menu of the maintaining is used to add the filters. The filter wheel can instatl nine filters at most. When adding filters, firsy select the number of total filters, then fill in the wavelength of the filters in turn, at last press Calibrate Key to save the setting. Attention: lf you want

to add filters, please contact with the manufacturer or the distributor.

into the new tamp testing menu. Firstly select the one filter and click start key, adjust the position of the lamp by hand, the value on the screen will change with the movement of the lamp. When the screen is full of data, click ,,Stop,, to stop the test. Click "Page down" or "Page up" to view the next screen. Keep adjusting the lamp until the maximum value. The normal value of the baseline is more than 15000. Verify the repeatability: Click the 'Repeat' key to go into the repeatability
test menu. Firstly select one filter, test times and row. The range of the test times is 5-8. Click "Start" key to test the certain row for 5 to B times. And the average value, repeatability and the CV will show when all the
tests are finished.

Please don't dismantle the instrument and add uncertain filters. Testing the new lamp: Click the 'Lamp' key to go

Advanced functions: Click the 'Advanced' key to go into the advanced functions as Figure 30. This module is only used by the serviceman.
Add ner,r fll_1:er

FirtEr r lEr]

Filter Filt:er Filter

tl
?
E

Filter I lEl
Fi.rter lEl
Fllter Filter
4 5

I 451

t-t l-t
61 6

l-r

Fil-l:r=r I'tE

l. EI
t-

Lllilrrate

"r'

r t r-l1t

al:p Fers

dr.r

J e

Figure 30

8.2 System Log \cte the important

information of the system.

LJ

8.3 Date Delete

, click the 'Data Delete' key to go into the menu of data deleting. tt is suggested that the user delete the old data after ln the system menu as Figure
31

half an year to keep the system faster.

There are five ways of deleting the patients:

o o o o o

Delete the patients' data three months ago. Delete the patients' data one month ago. Delete all the Patients'data. And delete the QC data by item and date. Delete the Plate data by date and plate.
DfrtE DE]-IE

tiPatients QDeIEtE dBtE three onths Eg'l fiDelete data one Ioonth aga (-iDelet:e aII patlents dt8 fr [[ uata fl Plate
Dat:a

| ,-,.=.-

,-"1 |
31

**.-"

Figure

8.4 Word book

ln the system menu as Figure 32, click the 'Word book' to go into the
editing interface of the wordbook.

There are seven items in the workbook: Laboratory, Department, Analyzer, Sender , Sample, Diagnosis and Unit. Firstly select the radio circle of the editing item, then edit;
Add: fill in the text box, and click the'Add'k"y; Modify: Select the item and fill in the textbox, then click the 'Modify' key; Delete: Select the item and click the 'Delete' key.

-24-

Ii'lrd
Irl

Enok

Diagnosis

fi
Q

Lah

r r r:,:

rlC,

epartrnerr

Inallzer fi Ser:der Q Saup]e (}l filagrrosis ff Llnlt

Add

I'l'rdity

DeIrte

FEturn

Figure 32

9 Search
Click the 'search' icon in the man menu as Figure 33 to go into the menu of data searching. The Patient Data, ltem Report, Plate, QC Report, Standard and Statistics can be selected from the column'search Mode'. And more detail

condition can be selected from the'search Options'. After selecting the searching mode and option, just click 'oK' to begin searching.

fi fi fi fi fi fi

Petierrt

Send Date

Iteu
Plate

TeBt
I'leme

Dt:E

tltl Feport
Star:,3ard

SanpIe

I,Ja.

l-l l-l l-l l--l

5tatlst1,-:s

Ltk

E o

Figure 33

9.1 Patient data searching

Set the option of each searching and check the option box. lf the option box s '"rot checked, the searching condtion is not valid.

lf the patient information is not avaitable, the sample data cannot

searched in the patient report.

be

It is suggested to set the content of each searchng option before check the ::tcn box and to select the date before the name and sample number. The table of the patient data searching result has five columns including the

-25-

sendng date, sample number, name, sex and the total numbers. Select the patient in the table. Click the 'patient report' key to see the patient

reports. Click the 'patient information' key to see the information of the patient. CIick the 'Print' key to print the patient's report. The instrument supports the consecutive printing: there is a 'P' flag in front of the sending date after selecting the patient. Select all the reports you want to print and just click 'Print' key to print
them.

The sample with no patient information can not be searched in the patient
searching.

9.2 ltem searching

The function of the module is to search for the records of the same item by the date as Figure 34.

fi Patient
!ffirten

Iteu
TeEt

I'lB
D1:e

hrB"

fr Flnte
S 0c Feport

l- ,otnrx-ilr]

fi Standard fi Statlstlcs
0k I
Esc

Figure 34

The item searching result show the patient's name, sample number, result value and the qualitative of the specific item and date as Figure 35.
200?-03-9 HBeIg table Sauple totEl:94 nit: Fet. EreE:
Io
I,l aro

SaupIe

EeEuIt 0uEIitEt]"ue
8. e25 0. 5r4
D. 588

j
D
J

Positiue
Iegatlve
I,egtlvE

4 5 6 7

4
5

6 7
D

0. 626 2. 09e 0. 663

O. 5B

Iegative

PositiIIe
I'EgEtive

Negative

lr"s- u;l

IF"s-

D*;l I P.d*l I F*,*

Figure 35

9.3 Plate Searching

Select Plate mode and set the date and the plate number to search the plate

-26-

as Figure 36.
DEtB Search

Search llode

Search

ff Patlent ff Iten S PIate fi [tI Fepnrt fi Stenderd fi Strtistlcs

0k

TEst DEte
FLEi:E No.

t--tr

atrtrr{f-orl

Esc

Figure 36

9.4 QC Searching
Select QC report mode and set the item name, month and the number to search the QC data as Figure 3T .
Data Searrh

Search Hode

fi Patlent ff Iten fi PIate S tJtI Eepnrt fi 5t:r=ndard Q Stntistics

rlk Esc

n*r*F-Tl

l-l

emi-oi-os

Figure 37

The searching result show the QC data.. X.. SD and CV value" The 2nd eC has a prefx of *. click "QC graph"to view the graph of ec as Figure 3g.
I:
?-

Test
2

Date

YrIue
9U rl

007-03- 10 I4.

Unit:
Eatch II,:. :3tl?DI X = .50
5D = ll.Zll llt = 20.953

X=2.

2007-03-I1 . ?Srl ?007-03-I1 1s. 961 :3 It07-03-t 2 2.74 -( i00?-03-12 I5. 4rl3
00?-03-13
. toJ

50[ 5D=. SrlD CT=2r1. 953

rl I

XD?-rl3 T4 QC graph

rl

X=18. 0r]0 SF=I. rl00

rtT=ZS.

6I

"::007-03-13 r5. t75 _r. 2007-03-14 4. 995

2

00?-03-14
Page
Dorun

r.

141

Erttrh I,lrr. :3t10?ll4 X = 15.ll0[ 5D = 1.[ l]t = 25. Elll

Feturn

15n

-t5D
-Z5D

-35D

-,

!!

Delete tII liraph

rjrl t

rl[ a

Tro [l]

llC Dats

Frint Feturn

Figure 38

on zt

9.5 Standard Searching

Select Standard mode and set the item name to search the standard data as
Figure 39.
Search I'lode

Data Seerch $earch Setup

fi fi ff fi S fi

Patient:

Iten
Plate
tJtJ

Feport

Standard

Statlstics
0k Esc

Figure 39

TheCut-Off item shows the absorbance of the reference and the formula. The quanttative item shows the table of the concentration and absorbance of the standards, and the graph of the standards as Figure 40.
HEs,$g Standtrrd

llTUt Standard
Ilalue
0. z6 I 'l1:n UuLti rlon. f . il[t] 2. 0Etl 3. 0 4. 800 5. 080

Hepatltis E Surface Intigen rlut-0f f Erl . 26

FEF T] AE5 FoErouIE

E5
tl . Es rl . 480
r_. 1

. 098

e. l+I'1

]l

r.
I

450
q'Jq

1. 0.
tt-tt-

F;l@
9.6 Statistics
Search
I,lode

--8.0 1.8 3.6 5.4

l-.,".1
Figure 40

ffi

s.0

Setup

Q Petient Q lteu

Q Patien =nt
SarupIe fiIteu 5 rlc S It:ero 0 StErt DE1

S PIate S Q[ Feport

fi Standard [iStetistics [k I
E=c

End Date

t"lffiTl
l-i'?-n-'ffill

Figure 41

The Statistics Function is used in the statistics of the patients, samples and
QC data in the customzing time as Figure 41 &42.

-28-

FEtlent: StEtlEtlcE Fstient nufi: I

Ido

Ilonth
tltl
?

I,ilI,1

- 01

rl rl

Stltl?-tlE
Stltl?

-tl5

l-r"-*',rl
10 Report

r"r-

,-,*l I

--,*"

Figure 42

In the main menu as Figure 43, click the 'Report' key to go into the patient report menu. The patient report is a shortcut of the latest patient searching. The result of searching by the patient in the latest sending date is as same as the
patient report list.
Patlent TahIe

IF"-1=* F-r-*l tp".1*. rr,f"l

I,J

Test: ate SaropIe

-tl3 - rl ! 007-t:t3-r:rl
z L-rtlT Z
J

ar e

5e>r

T'lteI a

I
I

e?-rt3-0s

4
tr

3tl?-tl3-tls rlrl?-tl3-tltl
-tl g rlr:tT-[3-t]S
30t_t? - tl3

I
1 1

I
3

StltlT-tl3-s

Ptge

l-l

Fage Doun

Select AII

Frir:t Feturn

Figure 43

The module is used to search and print the latest patient report quickly. The patient table is in the latest sending day. If there is no patient in the day, the
result may be in the old days. Select the printing line, and the first column of the line will appear a "P" which

means the line will be printed. Multilines can be selected to print. And click "Select AIl" to select all the lines in the table. If there are more than one P before the line, the patient report will be printed out continuously. The P will disappear
after report was printed.

Click the "Patient Report" or "Patient lnfo" key to view the report or the information of the selected patient as Figure44.

-29-

ljEIFl-E Un.
f t: e:
HEeA,-t

:.1-

I,laue:

f'EtEr

:iex:Ila.Le

nr_re:

F.rsr-rIl: Llrlit:./[r-a1

I,lsrsl- Are

1. [1]

Fosltl'.re

Faqe

I.J

Fage

DErrrn

&dd

ur=l-tr LE

Prlut

F e tr-r

rn

Figure 44

11 Shut Down
When finished usng the instrument, shut down the power directly. All the
saved data is stored in the FIash memory and reliable for long time.

12 PC mode
12.1 Software lnstal lation The instrument can be controlled by a PC through the serial port, usng the

PCsoftware interface,

more powerful, easy to

connect hospital

management system,if using this method, the instrument must be set as follows: (software, see the software online help)

o o .

Click "System CIick "OK"

rr

Select the "PC Mode"

Note: To

install the

software, please

contact the dealer or manufacturer.

Set

to"PC Control", the main interface on the "sample test" button will disappear.

12.2 Software Operation Operating systeffr: Windows XP Hardware environment Pentium ll1350 above, memory 128M, 500M or
more free hard disk capacty, resolution 800 * 600 and above

Communication: Seria! Communication

Communication lnterface: RS232 serial port

Gommunication baud rate :19200

12.3 Software seral communication protocol and code

1) Frame format
Table 4

Frame head A5H

Sequence
1 byte

length

PDU type

Data

Check
1 byte

2 bytes

2 bytes

N bytes

-30-

Frame head: Because synHeader is ASH, therefore may not appear the same byte as ASH in the other fields in a frame, in order to avoid the frame analysis grammatical ambiguity; if in other fields appears AsH, then in after that fills again an ASH byte. Receiver when analysis, meets single AsH byte to think it

is the synHeader, meets two consecutive AsH byte to think it is other data byte, this time should neglect an ASH byte.

Sequence: Back end may wilfully fill in; front end must fill in the same
sequence number rn the response frame.

Length: The length is the total length of PDU type field and data field, not
including the synHeader, sequence and checkcode

PDU: See Part2

Data: See Part 2 Check: Single-byte XOR checksum algorithm, computation scope: sequence
number, length, PDU type, and data.

2)

PDU type and data

0x0001 reset 0x0002 Read the front version 0x0003 front version
0x00'10
command completes and no data is returned

0x0011

command to complete, but an error occurred 0x0101 shake; Vibration ELISA ptate

0x0102 switch the tight fitter 0x0103 read the air's AD value 0x0104 AD value

0x0105 0x0107
0x0108 0x010A 0x010B
0x010D

ELISA test board

0x0106 ABS Vatue

AD value

of

the last test

AD value lamp switch (0 Open, 1 Close)

0x0109 0x010C

read lamp's state lamp's state read machine's lD

machine's lD

-31 -

3) Send commands

and responses
Table 5
Receive Expected Data /Send response

Type

Command function

Timeout

Other explanations

After power on,use this

command
0x0001 reset Send
0x001 0

to

judge

5 seconds

whether the correction

of coefficient is correct

0x0002 0x0003

Read the

front

verson

Send Receive

none

0x0003
none

1 seconds

front version Command comPletes and

4 bytes

none

0x001 0

recelve no data is returned

none

none

none

Command
0x0011

to

complete, but
occurred

an

error

recetve

two bytes

none

none

Vibration SPeed

0x0101

Vibration

ELISA Plate

Send

Two bYtes first bYte ls speed Second byte is times

Vibration 0x0010

time +3 seconds

1. 2. 3.

slowly
middle

fast Vibration time:

1

-60 seconds light

installs seven
one byte:
0x0102

switch

the

light filter

Send

0x0010

3 seconds

filters, the user can

increase two

Filter number(0-7)

read the
0x0103

air's

AD Send none

0x0104

1 second

value

16 bytes of
0x0104

AD none none

I row 16 AD value of
the air
Continuous:

the

air's AD value

Receive

value One byte test mode

1

Oseconds

0x01 05

ELISA

test board

Send

(0: continuous; 1:
Step)

0x0106 Step:

30 seconds

-32-

&

192 bytes of data,

192 bytes, 96 holes

all

values have expanded Absorbance test

0x01 06

Receive

of

Value

the

1,000 times
none
1 seconds

10005 too

16

absorbance
absorbance value

said

much 10,006 that is too

small absorbance

0x0107

AD value

of

the last test

Executive Directive to
Send none
0x01 08 1 seconds

be tested

208 bytes, 96 holes

of the 16 AD value
0x0108

AD value

Receive

+8 rows the 16 air

AD

none

1 seconds

0
0x0109

means open,
0x0010

lamp switch

send

second

means closed

0x010A

read lamp's state

send

none

0x01 0B

1 second

one byte:
state
0x01 0B

lamp's

lamp's state

recerve

two bytes:
lamp time

none switch

none

0x01 0C

read machine's ID

send

none

0x010D
bytes: none

1 second

0x010D

machine's lD

nine
recetve

none

machine's lD

-33-

4)
\

Error number

0x1101 self-test error 0x1102 Order overtime 0x1103 lllegal orders

0x1
1

04 lllegal orders investigation

0x1201 lnvalid filter Ox1202lnvalid Vibration ELISA plate time

Oxl2OS lnvalid Vibration ELISA plate speed

Ox1204lnvalid Vibration ELISA plate mode

0x1205 No reduction filter signal 0x1206 ELISA plate without reset signal Ox12O7 ELISA plate fixed or positioning signal slot Optocoupler
0x1208 AD not OK signal
0x1

209 lnvalid voltages

0x120F Light source is too strong

0x1210 Light source is too weak

5) Serial communication parameters

Baudrate: 19200
Parity: 'N' Databits:8
Stopsbits:1

-34-

IS09001& IS013485

Certif ied

Sinnowa Medical Science & Technology Co.

Acld
'l

Ltd

0ilin Industrirl I'irt'li \rrn-i ing Chinr 7'P 2111:15 c1:86 025 81127188 s:10 1 lriir:,36 025 81127199
/\\'\\r\\,. s

hl tp'./

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