SINNOWA@
i+-r'N.F
it+
Table
of Contents
1.1 1.2 1.3 1.4 6 TESTI
-1-7 PATIENT INFORMATION.
...29
I
-2-1
lntroduction
1.1
Main Features
The features of the filters are shown in table 1 :
Table
I
Feature Technical Parameter
Wavelength Accu
racy
( nm )t2.0
Half-Width ( nm ) <10 Transmission Peak
Ratio
(%)
>35-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 swingst10%
.1,2
Specifications
-Graphical
operating interface, menu designed for convenient use.-500
programmable analysis items.Four
measure
method
:
Single
wavelength/Dual
wavelength/Fixedtime/Kinetics.
-Eleven
analysis means,ABS
/
Cut-Off/
Single
point
regression/
Multipoint
regression/
Linearregression
/
ABs%/Exponential
Regresssion/
Logarithm
Regression/
DualLogarithm Regression
/
Logit Regression/
Polynomial Regression.-
Performing 12 different tests
just in
one
plate. Flexible Plate
Position withBlanks,Reference,standards.Samples and QC in one screen.
-
Proven optical system
with
8
channels optical
fiber
scanning,
auto
platecentering system positions
the
center ofthe
cell accurately.Get reading result injust
10 seconds.-
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:
Figure
I
O
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 Labelk,
-2-1.4 Specifications
o
Place the instrument on a clean, sturdy table or bench.lt isimportant
to
keepthe
instrument
in
a
ctean, relatively
dust
free
environment
to
ensure maximum performance.I
Weight: Outline Dimension:460mm
(L)
x360mm
(W)
x21Omm(H)
AC(220L22)V,
(50t1)Hz
F2AL250V 2-9Sx20 mmTemperature:
*s-+.40c;
Rerative humidity:
2}o/o-gooil; Atmosphericpressure:
860-1060hPaStorage temperature:
-10c-50c
Light Source: Tungsten Halogen Lamp,
OSRAM64607,
BV/SOW
Wavelength:
405nm,
450nm,
4g2nm,
630nm lndicationr3flge:
Continuous
mode<10s,
Stepping mode<20sARM core series Programmabl
e
ltems: lnterface:"r'.
usB..
Mouse and keyboard interfaceDisplay: 320x240 LCD
lnput Mode, Touch Screen ,Touch pen
Memory Capability:
2000
Plates
( 96 holes)
test data2
lnstrument
Set-up
2.1
lnitial
Start-up
-3-o
Connectthe
power cord tothe
back ofthe
instrument.Before connecting theinstrument
to
the
main electrical supply, check
that the
AC
voltage
isappropriate for the instrument.
3
lnput operation
3.1
Touch Screen and
Pen
ln
the
MicroplateReader, the
penis
usedto
click on the area of the visualscreen. The
valid
methodof
input operation isthe
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(likethe concentration) as Figure 3.
Pletse inFl¡t Lll[ cEutra=t ¿res ü - I5
-trtrtrr
trtrtrr
trtrtr8
trtrtr8
Figure 33.3 Gharacter
soft
keYboard
Keybord
is
shownas
Figure4. lt
is
usedto
inputthe
character string. The"<-"
keyis
usedto
deletethe
character, andthe
"CAP"key is
usedto
shift the uppercase and the lowercase of the character.FLease input l:,:spltal t:alte Flease irrput hnspittl r:aue Hax. tenr¡tlr :rrJ llax. LEngth f,ü
tEE-E-EtrtrtrtrEitrtrEltrEltrtrtr
Etrtrtrtrtrtrtrgt]_trtrtrtr
Etrtrtrtrtrtrtrtrtrtrtrtr
Etrtrtrtrtr_trElIl_trEgtr
Etrtrsssstrtrtrtrtr
ffitrtrtrtrtr@
l=,,-ltrtrtrtrtrtrtrtrtrtr
I il,1-
]trtrtrfltr@trEtrtr
fqmn-l-l@@tE
EEtrl-l@@tI
Figure 4-4-3.4 Date/time
soft
keyboard
It is
used
to
input
the
date and
the
time
as
Figure
S. The
format
isYear-Month-Day and the "Today" is used to input the date of today quickly.
PLease input drte
2000-rl1-rl1 309S_12_3I
r
trtrtrr
trtrtrEq
trtrtrE
trl-r_",
lffi
Figure 53.5
Formula
soft
keyboard
It is
usedto
input the formuta as figure6.
There arefour
N(Negative).. fourP(Positive)'.
eight
D(Standard)..MIN(get
the
minimum value).. MAX(get
thel
i
maximum value) and the common operators.Please 1r:put tor¡luta L
Ilax. Iengrh S0
EEEEEE4ETE@
EEEEEEEE@
EEEEEEEE
I * I
lil-*l
fofr-l
IFI
Figure 6
4
Start-up
4.1
Procedure of start-up
Turn
on the
power switchon the
rear panel. After about three seconds, the instrumentwill
performan
initialself
diagnosisthat
requires aboutone
minute.Please
wait
ten
minutes
for
the
instrument
to
warm
up(reach
thermalequilibrium)before reading plates.
The procedure of start-up inctudes:
1)
Load the program;I
-5-2).
Access the user data;3)
Wait for the stable light of the Iamp. It is necessary to wait about five minutesfor the
stabilizationof the
lamp before thefirst reading. (The
resultof
O.D.may be not accurate if the lamp is not stable. )
4)
Self diagnosis of the optical andthe
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.JB
lEl
FeportH,q
SearchIE
Info TestI-F\
u
atienttr
--:-=
E SYsteü5
ltem Setup
Choose
the
ltem
settingwindow as Figure 8:
¡con
The user could set 500 different items at most.
5,1 Measure
method
The reader has four measure methods.
&
w
Iten
SetupFigure 7
in
the
main menu and
gothe
item]D Iteu I,¡EDe FuII I,laue anEIYS].E
I IlBsAg iepatitis B Eut-0ff
Z IlEslb lepEtitis E Eut-0ft
3 HtseAg lepatitis E [ut-0ff 4 IlBelb lEp8titiE E f,ut-0ff 5 IlEcÁh lep8titis E Cut-0ff
Page Up Page Dorln ller¡ llodifl DeIete Feturn
Figure 8
-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
measurethe
OD.The
resultof
OD isthe difference of the main wavelength and the reference wavelength.
5.1.3
Fixed
time
A
first
absorbance measurement
is
made
for
each
sample
after
a programmed incubation period, and a second measurement is performed after adefined interval. The fixed time method should use the single regression analysis method.
5.1,4
Kinetics
A
first
measurementof
absorbance
is
made against
the
BLANK after
a
programmed incubation
period.
Next,new
measurementsare
madeat
definedintervals
of
time. The absorbanceis
calculatedas the
meanof the
increase (ordecrease)
in
absorbanceper
minute.The
kinetics method should useonly
onewavelength.
5.2
Analysis
method
There are eleven analysis methods, including the comprehensive qualitative
and
quantitative
data-evaluation
functions
with
cut-offs,
curve-fits
andtra 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 formulaz
cov =x
x NC+y
xpc
+ FacNC is the O.D.
of
the
negative referencemateriat, PC is the O.D.
of
thepositive reference
material,X,Y,
Fac is the coefficient, which is set in the reagentinstruction.All
the other
kindof
qualitative formulacan
convert intothis
formulaformat.For example:
if
sample oD/Negative Ref.oD>2.1
is
the
positive,thenX=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 regressionmode:
ore
standardneeded,
use the origin and then
t-2)
standard O.D. to fit the curve as Figure
9.
(X:concentrate,
Y:O.D.)Figure9
Multi point
regression:
Two to eight standardsneeded,
use all the standards O.D. to fit the curve as Figure 10:C
Figure
l0
or
decrease),theresult
is
error
aslf
the
curve
is
notFigure 11 :
monotony(increase
o.D.
3)
Figure l1
Linear regression: Two to eight standards
needed,
use these standards to fit the regression curveas
Y = kX + ó in Figure 12:Figure 12
-8-I
4)
Exponential
Regression:
Two
to
eight
standards
needed,
use
thesestandards
to fit the
regression curyeas
y
= kebx,all
the
standard O.D. mustbe positive number.
5)
LogarithmRegression'
Two to eight standardsneeded,
use these standardsto
fit
the
regressioncurye
as
Y-kLnx+b,all
the standard O.D. must
be
positive number.
6)
Dual Logarithm Regression, Two
to
eight standards needed, use
thesestandards
to fit
the
regressioncurve
as
y:lg$Lnx+b),allthe
standardO.D.
must
be
positive
number.
lf
setting
the
concentration
asx'
=Lnx ,Y'
=Lny,then
the regression formula turnsto
y, _k,x,+b,
.7)
log-logit Regression: Two to eight standardsneeded,
use these standardsto
fit the regression curve as Log-Logit method.
The_ abscissa of Log-logit curve
is Concentrate, the ordinate
is
¡-!-
oD
^concentrateofthestan,:::";:',,?",¡t¡l;m';:il:::,Hi:,"
B)
Polynomial Regression, Two to eight standards needed,use these standards to fit the regression curye
as
Y-
kxb,
all the standardo.D.
must be positivenumber.
5.3
Add
New ltem
choose
the
ltem setup icon
in
the
main
menuwindow as Figure 13.
and
go
into
the
item
listfte¡l rrane tlTl,lL
Fr-¡lt- llsnre
l-.Trr.rr
I
Feagerrt
l@-rrrll:tai,'ra'elength
rEsrI,re1:Iro,:fEffiEl
l.I.rTElArrar-s=is
lffiTTiEEEl
S :iirJ'¡1e Salr f,, D,:trhte
Ersnl: Ilu*.|ffi| :i¡rr
ff tlnluun r¡ir:u::
I'ro.
l..Tl
Fer.
rrealffitrl - Iffil
I
r.¡.-*I
f-
,-,,,I
I
E*
I Figure 13
Select"New"key to add new item.
The parameter of the item setup:
o
ltem name: ltem brief name, string including twenty characters at most, blank unallowed;}
-9-o
Full name: ltem full
name,string
includingthirty
charactersat
most,
blank allowed.o
Reagent: Reagent name,string
includingtwenty
charactersat
most,
blank allowed..
Test Method: Select the test method from the four methods.o
Main/Second Wavelength: selectfrom the
wavelengthlist,
andthe
secondwavelength should be different with the main wavelength;
o
Analysis: Analysis method, selected from the list of methods..
Single Sam/Double Sam/Column minus: thetype of the
sample,the
defaultsetting
is
single sample,
the
double sample means double sample
for
eachpatient,
the
column minus method isa
specific method,which
usesthe
secondcolumn minus the first column as the sample value.
o
Blank
Max.'
Definethe
max. value
of the
reagent
blank.For example,thereagent needs
the
blank less than 0.05,thenthe
upper blank must be 0.05.1f theblank
O.D. is
larger thanthe
upper blank, "Too IargeOD
blank"will appear andthe maximum blank is used as the blank automaticly.
o
Sort No.: Define the sort ofthe
item inthe
patient report. The small No. is inthe front of the list. The default value is 100.
o
Ref.Area:
set the normal
areaof the item.The area
is
used in the
reportonly.The area value don't
take
part in the formula calculating. The default valueof
the area
is
0.000
N
0.000, and
the
column
will
not
if the
area
is0.000
-
0.000..
Analysis Means:
choosethe
analysis meansfrom the
list.Accordingto
the differentmeans,
the screen will appear different windows.o
Waittime:
used in the Fixed time method and Kinetics method, the range of the value is 10to
120;o
Testtimes:
Used in the Kinetics method, the range of the value is 2to
10. If the analysis method is Cut-Off, click "Next" to view the menu as Figure 14:.
Negative/Positive RefArea'
The valid
referencearea of the
Negative andPositive,
the default value is0.000-4.000;
o
Negative/Positive1-4:
Usercan see the OD of the
Negative/Positive after test, or set the OD directly without test.-10-tr.trüpl
ffi
lresari,etrEI
l4JrtrúlPnsitir¡e Fef Area
f nrrtrü
|
trEI
F,rsirirEtrEl
I r.ltrü| Iiegative I I'IEgEI:iTJE T IJegatirre lr I,legatilre 4 Figure 14 Click "Next":
o
Qualitative GroupName,
User can define the name or signal of every group;Click the label "Group
1"-"Group
5" to set the predefinedname,
which willshift between the "Negative,Weak negative,Neutral,Weak positive,positive,,;
o
Formula(Cut-Offvalue):
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 OD
Figure 15
From
the
manualof the
EL¡SA k¡t,the formula
of the
cut off
is
,,cut
off
value=Negat¡vex
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 isto get the large value of the NC1 and
0.05,
so the finalc.o.
formula is:2.1.MAX(NC1 ,0.05)
This is the
formulaof the Group
1.
Thereare four
formutasat all. And
thevalue
of the
formula mustbe
"Form ula4
>Formula3>
Formula2>
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.
I,Jer¡rtlue Fef Ire¡
Fositl',:e l_ P¡sitire X Pnsitire f, Fr:sitir,'e 4 | ürrstl lr-rrrtrül I ú. orrr I
I-ffi|
lP=*j",,=l
f*E [
ü,-
If
E*
|Iffil
l'trrxrtr IIffit
| ür,ütr |ü
llr.¡af itative FnruuLa
lroup
llGiIll+lffil
ü.2+1I¡I+FI
{
L'irrrup ¿l'iiE'?Il+I-l
Erc,u¡ri[-l+
l-l
Group
4l-l', I-l
rirnup
rl-l
Select the f'lrüu1u[ u= f,Ü rralue
llllclr fsrlüu1a 1¡he1 trErI dispra'j t¡h':'Le tnrrür'¡1e
fp.",,i",-l
t
n-*
I
I
úkI
I
E="I
Figure 16
lf the ana¡ys¡s method is quantitative method, click "Next" to view the menu:
o
STD numbers: define the numbers of the STD..
DiluteMultiple'
definethe dilute
multipleof the
sample, andthe
calculatedvalue should multiply the dilute multiple.
o
Unit: Choose unit from the 24 common units in the list.o
Dual STD:
lf
check
the
dual
STD,all
the
standards
in
the
plate
will
bepositioned double times.
.
ABS
percent:
check
the
box
to
use
"D^
+"100/o
as the
ordinate
of
thestandard
graph, the
D0 is
the
reference stañdardof
100%O.D., and
the
D0needs no concentrate.
lf the
item se¡ectsthe ABS
percent,the first
standard isD0
when
positionthe
plate.The dual
Iogarithm regression cannot use the ABS percent because of the ordinate is in logarithm..
STD
concentratetable:
Displayand
selectthe STD
concentrate. Attention:AII the STD concentrate should increase.
.
Modify concentration: Modify the selected concentrat¡on as Figure 17.sTD
uuu
ft f,,i1r.¡te I,lr-r1tip1e E Uni-tI
r:r.rrl[.+rs
5TD Percent: Hod j-t1 llsncenl:ration,5TD f,oncentratiun shor.lld increast
lp'-,j--llil.=*l¡
n-
IIB*
IFigure 17
Click "Next" to set the qualitative group and formula as the Cut-Off item.
Click "Next"
to
setthe
Quality Control.The
menuof QC is
demonstrated in theID Il¡ncerrtration I I. tltltl Z, z. tltltl 3. t-il:il:l 4 4 . r_il_r L-l E J 5. IUr]
-12-next sect¡on.
After
settingall the
parameters,click
"OK"to
savethe
item. Attention: Thesame name of the item is not allowed.
5.4
Quality
Gontrol Settting
The
qualitativeand
quantitativeitems both could set two
eC
materialsas Figure 18. @uc r
Enc
¿ QHnoron X- 5Ilfi
t-'I ff fnstart n¡eans QHnorrrr H_ SD O L-J 0 lrrstBnt nJEans Ilodify 5I Tabte l"esI
E="-lEarch
r,r".lffi'l
Eatch l¡o.[:ffi|
ruerase
f
r-álplttutti-ruree
I
l,]rrIt1-rülP.*i",,=l
I *¡
Figure
l8
o
BatchNo.:
The
batch numberof the QC materials,
different batch QCmaterials should have different
eC
data;o
Average:
The average value of theec
materials(F);
o
sD'
The standard deviation of theec
materials (.gD).The
routine
quality control
in
room
includes
the
routine
conditions variance-knownvalues (
RCVK)
and routine conditions variance-unknown values
(RCVU).
For RCVK,
select"Known
7
.
SD", ohd inputthe
7
and
5D
in the manual of the QC materials.For
RCVU,
select L-Jor
instant means.The
Levey-Jenningsrule
uses the front 20 values tocalculate
7
. SD, and makes theeC
graphfrom
the 21rt value.The
instant means usesthe
Sl table,
calculates
x.,sD
and
makesthe eC
graph from the 3'd value.
The limit of all these QC
methodsis
i
tzs.
with
the
developmentof
thecomputer, there are
moreand
more efficientcontrol
methods.The
instrumentintegrates
a
common multi-rules control method:westgard
Mutti-rules.
Here
isthe routine of
westgard
Multi-rules as Figure 1g:-13-B
t
Outof
control Figure 19I,
t,
I,
I,
I,
:l'ffir
In
control5.5 Mod¡fy
the
item
Select
an
item fromthe
list and click the "Modify" keyto
modifythe
itemsetting.
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
readingmode.select the parameter from the window to modify the setting as Figure 20.
It""d s.-""ilI IE="J.=rr-i1 | Sterltri]. HÉDe:
PI€te Setr¡I]
DiEectiorr QIIorizonta]- OVerti,=EI I{ovj-r¡q Hode Q Corrtinuous Q Steppj-ng shÉkir¡g Hode sharr:.net s¡:eed ls]", -E 5hÉk:-rrg Tiue lü s=*o"d E
I * I I
"="1
Figure20-14-T
o
Loadstencil:
toad the preset stencil of position;o
PlateDirection:
serect Horizontar or Verticar position;o
MovingMode:
select the plate continuous moving or steppingmoving;
'
Shakingspeed:
select theslow.,
medium orfast shaking speed;
o
Shakingtime:
select the time of shaking plate,user-defined area is from
10
to
180 second.6.2 Plate Hole
Table 3
(_-
o
The direction of the plate,s moving is
6.3 Stenc¡l
Click the "Load Stencil" Button to go to the Plate Load tnterface
as Figur e 21 . t -".r" ,r, I
F*-
t,-,;lI-l
I
--.1
Figure 21select an
available stencil inthe
list and clickok
to
toad
the
positionof
thestencil'
All
informations includingthe direction, moving mode, shaking
speed, shaking time, the item and the type of each hole are stored
in the stencit.
6.4 Hole
Position
User
can
position
the
sampre(s),
Brank(B), Reference
(N, p), standard(D),Quality
control(oc)
in any hole of the
standard
96 holes plate
asFigure 22.
P.l-Ei:E LoEd
III 5tr=I.I':i1 f t: e¡l Hrile ! 1 2 3 4 5 6 7 8 9 10 11 12 A A1 A2 A3 A4 A5 A6 A7 87 A8 B8 A9 B9
410
810All
412 B B1 82 B3 B4 B5 B6 C6 811 H^12 C c1c2
C3 C4 C5c7
CB C9c10
c11c12
D D1 D2 D3 D4 D5 D6 D7 DB D9 D10 D11 D12 E E1 E2 E3 E4 E5 E6E7 EB E9 E10 E11 E12
F F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12
G G1 G2 G3 G4 G5 G6 G7 GB G9 G10 G11 G12
H
iH1
H2 H3 H4 H5 H6 H7 H8 H9 H10 H11 H12-15-I
,
l¡
'
lt
¡¡
ll
F
ll
,
lt
*
llr-r*rl
rteu
<+rst
:FIarl f
enorrd
4rhI Z 4 E FJ ? o ! Itl ]I la ¿ E I'11 PI gI J¿ JJ JD EO E ü D E F L-l H
f,urrent op: f, Itero I,leue: HEsAg
l,.*l
ls.-"-i{@
tiil
IffiI
Figure 22
The procedure of the position:
a)
Click "ltem" to select the item;b)
Click "S,B,N,P,D,QC" to select the type of the sample;c)
CIick the hole on the screen to position;d)
When
multi-items position,
after
finishing
the 1't
item,
click
the
;"2nd,3'd,4tn"
to
select the other item.
CIickthe
">>"if positionthe
Sth-12th item. After changing the item, the positioned hole will be dark.
-
SampleUser
could click any
holeto set the
Sample.CIickthe
hole againto
modifythe Sample No.The area of the Sample No. is from 1 to gg9.
-
BlankThe blank is used to do zero adjustment.lt means that all the other hole's OD
should
minusthe
BlankOD.lf the
BIankis
not
positioned,the default blank
iszero.
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 ReferenceThe
negative referenceis valid only in the
Cut-Off items.Usercan
positionthe
negative
reference
or
positive
reference
according
to
the
Cut-Offformula.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.lfthe
next
test
of
the
itemdoesn't position the reference, the program will use the saved reference value.
-
Positive ReferencePositive Reference is set as same as Negative Reference.
l.
--
StandardThe 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
ControlValid if the item has QC.
-
ClearUser can click
the
holeto
clear after selectthe
"Clear" button.And
only thehole of the current item can be cleared.
-
StencilThe
Stencilbutton is
usedto save the
positionedholes as
a
stenci!. Click"Stencil" after finishing
the
positionto
goto the
stencil operation interface. Inputthe 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 inthe first interface of the test.
-
BatchClick "Batch"
to
enterthe
menuof
batch position. Onlythe
samplecan
bebatch 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
Click the hole to set a hole;o
click
thenumber
(1-1»
to set a column of holes;o
Click thealphabet
(A-H)
to set a line of holes;o
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
movethe
plateand
readthe
absorbance automaticly. Thefirst
time of thetest
needs some minutesto
stablizatethe
light source as Figure 23.I
-t7-The liqht iE sttrhlE Te=t 45ü IJavelength Setting f iIl:er
6.6
Result
view
and
After
the
plate reading, clickthe
"Position"to
viewthe
positionof the
plate.CIick
the
"ABS"to view the value of
absorbance. CIickthe
sample hole tomodify
the value.Attention: lf the value is
Iargerthan
4.000A,the value willdisplay as 4.00*;lf the value
is
less than
0.000A,thevalue will display
as0.00*.
Click "Qualitative" to view the qualitative of the result according to the setting of the item.
Click
"Quantitative"to
view the
calculatedvalue. In
the
Cut-Off item,
thequantitative value is the value
of
S/CO. But in the quantitative item, the value isthe calculated concentration.
CIick "standard" to view the standard curve.
The default setting
is to
showthe
resultof
allthe
itenns. If onlyone
item iswanted, 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
all
the
values
by the
position.
The
holes
that
not positioned will be neglected automaticly as Figure 24.I
-..*-l
Figure 23
PIEre l,lo. :3 {{ ¡II }} ¿11 Lsr End 3rd 4th
t 4 5 6
¿ U. UU5 U. UUU .5. ¿
B U. UUU U. U9tr u. .)5tf . UJtJ
I U. UI4I U. UUU U. U9ts u. 554 I. UJ!
D U. UIJ U. UUU q. UU tt_ ltqñ . UJ9
E U. UUtr U. U9U T. UqU
F G H $ Position €IAEs $ tluantitatiue Q Qualitative Sar¡e I Print
Page Dounl Standard lFeturn
Figure 24
-18-7
Patient lnformation
Click
the
"Patient lnfo" icon in
the
main menu
to patient information as Figure 25.enter the setting
of
theFatirnt Inf¡ ll¡ 5 l,ln. ll a¡: e
+
I I Feter|
'"--
,,,
I
F"'=,-,;l
Figure 257.1 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 columnflag
1,show that the patient's information is finished already.
+
First test the sample:After finishing
the
sample test, thefirst
columnflag o
show that the testedsample has
no
patient information. Selectthe o
row and click 'Modify,to
inputthe patient information.
The meaning of the flag in the first column:
a
Patient information existed, but no sample test result.o
sample test result existed, but no patient information.r
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 thetest
result, the system willautomaticly 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 inthe
patient info menu orI--l
|
,,r'.,
II
--..=l
I
t-.-rl
Test Ilete-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;
Record No.: the record number in hospital, g 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.
SaupIe Sample N0. llaue 5ex Age Eed l,lo. Fecord Iüo.
l-t"=l
Dep.EtloentliEEffiEE
Sender LEborEtorl¡ Inalyzer Sead DEtet-t
It"b'*t"EI
t--lffirl
2007-03-09 lH"r.E
f-pl
t-l
t-l
Test dateffitE
Figure 268
System Setting
Click,system'icon
inthe
main menu andgo
intothe
system setting menu.There are four functions: System set, System log, Data delete and Word Book as
Figure 27.
-20-SIEtenl
Figure 27
8.1
System
setting
Select
the
'Systemset'
keyand go
intothe
system setting menuas
Figure28:
seriar
r,ro. ( rDI
reúua:-rlrllHDsIritEI I,lame FelrüEt Tj.tte
Dare
rir¡e
I
¿trrr.-o"-r6lIEI
Lar:guage lE"qli=h E Fri-nteE ITIr,==r"I -E
LrlD trtrnrrasr EI-
=lE Iil,:rk Hode 15r""cl.-"1"",=E
Hai-rrter-leRce Touch Defar-r-lt oh CanceI
EE
E
ffi
E
EE
Figure 281)
Serial
No.
(ID)
:
Show
the
identifier
of the
instrument,
not
allowedmodified;
2)
Hospital Name: The name will appear on top of the patient report;3)
Report Title: The name w¡ll 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
chang¡ng the language option,you
need to press "OK'' buttonto
restartthe instrument to take effect;
The Date and Time is used in the test and report, please adjust the date and
the time before us¡ng 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 pressedto
openthe
doorfor
addingthe
thermal paper (Attention:The
outer sideof
the paper is the thermal layer. The thermal layer must touch the thermal head.); SELkey is red when online, LF key is green when the power is on. Press SEL to turn
I
-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)
LCDcontrast:
Used to adjust the brightness of the LCD back light;9)
Work mode: Select the stand-alone modeorthe
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: Usedto
calibrate the touch screen. The touch screen is alreadycalibrated before leaving factory, so do the calibration only when necessary.
The use of the calibration:
Firstly calibrate
the
abscissaK:
CIickthe left
partof the
screen,the
screen wil! display the real pixel point, then click the right part of the screen, there will bea
pixel pointalso, if the
horizon distance betweenthe two
pointsis
longer thanthe two clicks, decrease
the
abscissa
K,
othenryise increasethe
abscissa
K.Adjust
the K
untilthe
distanceis the
same. Secondly calibratethe
abscissa B:CIick
anywhereon 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 asthe
abscissa. After finished the calibration, click OK to save and ESC to quit.12)
Default: Restore tothe
leaving factory state,be deleted.
The
initial setting includes23 test
itemsBut
the
setup inthe
System Configwill be
remained the touch screen and the setup of the filters.Click
OK to save the new
setting, otheruvise the after shut down.Ádjust lhscissa Abscissa
@l
r. trrl J,hscissa@l
ü Idjust ürdinate rJrdinate@
I. ü3 Drdinate@
-Zand all
the
user's input willand
some common words.including
the
calibration ofnew
settingwill
disappearE
E
E
E
EIear Default 0k Esc
Figure 29
'Maintenance'
key
to
go
into the
systemClick
the_ZZ_
Figure
29. The
maintaining module consistsof 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 filtersat
most. When adding filters,firs¡y
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
manufactureror the
distributor.Please don't dismantle the instrument and add uncertain filters.
o
Testingthe
new lamp: Click
the
'Lamp' key
to
go
into
the
new
tamptesting
menu. Firstly selectthe one filter and click start
key, adjust the
position
of the lamp by
hand,the value on the
screen
will
change withthe 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 adjustingthe
lamp untilthe
maximum value.The
normal value of the baseline is more than 15000.o
Verifythe
repeatability: Clickthe
'Repeat' keyto go
into the repeatabilitytest
menu. Firstly select one filter,test
timesand
row.The
range
of
thetest times is
5-8.
Click "Start" key to test the certain row for 5 to B times.And the
averagevalue,
repeatabilityand the
CVwill
showwhen all
thetests are finished.
o
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
IlEl
Fi.rter ¡lEl
Fllter 4 Filter 5 Filter tl Filt:er ? Filter E Fil-l:r=r I'¡tEl-r
t-t
l-t
l.
EI
I
4ü51 Figure 308.2
System
Log
\cte
the important information of the system.I
Ll¡lilrrate
"r' r t ¡r-l1t L al:p Fe¡rs¡¡ Á dr.r 6¡1¡ ¡ 6 J e t¡-¡ r¡
8.3 Date Delete
ln the
system menuas
Figure 31,
clickthe
'Data Delete' keyto go
intothe
menu of data deleting. tt is suggested thatthe
user delete the old data afterhalf an year to keep the system faster.
There are five ways of deleting the patients:
o
Delete the patients' data three months ago.o
Delete the patients' data one month ago.o
Delete all the Patients'data.o
And delete the QC data by item and date.o
Delete the Plate data by date and plate.DfrtE DE]-ÉIE
tüiPatients QDeIEtE dBtE three üonths Eg'l
fiDelete data one Ioonth aga (-iDelet:e aII patlents dñt8
fr
[[
uatafl Plate Dat:a
|
,-,.=.-,-"1
|
**.-"
I
Figure 31
8.4
Word
book
ln the
systemmenu as Figure
32,click the 'Word
book'to go into
the editing interface of the wordbook.There
are
seven itemsin 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 Enok
Irl c Diagnosis
Add I'l'rdity DeIrte FEturn
Figure 32
9
Search
Click the
'search'
icon in the ma¡n menuas
Figure 33 to go into the menu of data searching.The
Patient Data, ltem Report, Plate,QC
Report, Standard and Statisticscan be
selected from
the column'search
Mode'.
And
more
detailcondition
can be
selected
from
the'search
Options'.
After
selecting
thesearching mode and option, just click
'oK'
to begin searching.Ltk E o¡ fi Lah o r r r:,: rlC, D epartrnerr t Q Inallzer fi Ser:der Q Saup]e (}l filagrrosis ff Llnlt 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 cond¡tion is not valid.
lf
the
patient information
is
not
avaitable,
the
sample
data
cannot
besearched in the patient report.
It is suggested to set the content of each search¡ng 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 thefi Petierrt fi Iteu fi Plate fi tltl Feport fi Star:,3ard fi 5tatlst1,-:s
l-l
l-l
l-l
l--l
Send Date TeBt DÉt:E I'leme SanpIe I,Ja.-25-send¡ng date, sample number, name, sex and the total numbers.
Select the patient in the table. Click
the
'patient report' keyto
see the patientreports. Click
the
'patient information' keyto
seethe
informationof the
patient.CIick
the
'Print' key
to
the
patient's report. The
instrument supports theconsecutive printing: there is
a
'P' flag in front of the sending date after selectingthe patient. Select all the reports you want to print and just click 'Print' key to print them.
The
samplewith no
patient informationcan not be
searchedin the
patient searching.9.2
ltem searching
The function of
the
module isto
searchfor the
records ofthe
same item bythe date as Figure 34.
fi Patient !ffirten fr Flnte S 0c Feport
fi
Standardfi
Statlstlcs 0k I Esc Figure 34The
item searching result showthe
patient's name, sample number, result value and the qualitative of the specific item and date as Figure 35.200?-03-ü9 HBeIg table Sauple totEl:94
Fet. EreE: ünit:
Iüo I,l aro e SaupIe EeEuIt 0uEIitEt]"ue
¡
I j 8. e25 Positiue D J 0. 5r4 Iüegatlve 4 4 D. 588 I,¡egÉtlvE 5 5 0. 626 Iüegative 6 6 2. 09e PositiIIe 7 7 0. 663 I'¡EgEtive I D O. 5BÜ Negative
lr"s-
u;l
IF"s-D*;l I
P.d*l
IF*,*
I Figure 359.3 Plate
Searching
Select Plate mode and set the date and the plate number to search the plate
hrB"
I
l-
,otnrx-ilr]
Iteu I'lBüÉTeEt Dü1:e
-26-I
Search SearchI
atrtrr{f-orlt--tr
TEst DEte FLEi:E No. Figure 369.4 QC
Searching
Select
QC report
modeand set the item
name, monthand the
number to search the QC data as Figure 3T .as Figure 36. DEtB Search llode ff Patlent ff Iten S PIate fi [tI Fepnrt fi Stenderd fi Strtistlcs 0k Esc Data Search Hode fi Patlent ff Iten fi PIate S tJtI Eepnrt fi 5t:r=ndard Q Stntistics rlk Esc Figure 37
The searching result show the QC
data.. X..
SD and CVvalue"
The 2ndeC
has a pref¡x of *.
click
"QC graph"to view the graph ofec
as Figure 3g.I: Test Date YrIue
¡
2 007-03- 10 I4. 9U rl 2007-03-I1 ¿. ?Srl ?- ?007-03-I1 1s. 961 :3 It07-03-t 2 2.7ü4 -( i00?-03-12 I5. 4rl3 00?-03-13 ¿. toJ ":í:007-03-13 r5. t75 _r. 2007-03-14 4. 995 2 00?-03-14 r. 141 Unit:
Eatch II,:. :3tlü?DI
X = Í.50ü 5D = ll.Züll llt = 20.953 Erttrh I,lrr. :3t10?ll4 X = 15.ll0[ 5D = 1.üú[ l]t = 25. Elll XüD?-rl3 T4 QC graph ürl I ürl E X=2. 50[ X=18. 0r]0 5D=ü. SrlD SF=I. rl00 CT=2r1. 953 rtT=ZS. 6üI 15n -t5D -Z5D -35Dü
-, - !! Page Dorun Delete tII liraph Feturn
Figure 38 on zt -Searrh
n*r*F-Tl
I
emi-oi-os Il-l
9.5
Standard Searching
Select Standard mode and set the item name to search the standard data as
Figure 39. Data Seerch Search I'lode fi Patient: fi Iten ff Plate fi tJtJ Feport S Standard fi Statlstics 0k Esc Figure 39
TheCut-Off item shows the absorbance of the reference and the formula.
The quant¡tative item shows the table of the concentration and absorbance of the standards, and the graph of the standards as Figure 40.
HEs,$g Standtrrd
Hepatltis E Surface Intigen rlut-0f f Erl ¡ ü. 2ü6
FEF AE5 FoErouIE Ilalue T¡] ü. 098 e. l+I'¡1 0. zü6 llTUt Standard 'l1:n I UuLti rlon. ÁE5 f . il[t] tl . üEs 2. 0Etl rl . 480 3. ü0ú r_. 1¿¿ 4. 800 r. 450 5. 080 I q'Jq s.0
9.6
Statistics
F;l@
Search I,lode Q Petient Q lteu S PIate S Q[ Feport fi Standard [üiStetistics Figure 40 Setup =ntl-.,".1
ffi
SarupIe rlc $earch Setupt"lffiñTl
*
l-iñ'?-n-'ffill
[k I E=c Figure 41The
Statistics Functionis
used in the statisticsof
the QC data in the custom¡zing time as Figure 41 &42.]¿l 1. É 0. B tt-tt---8.0 1.8 3.6 5.4 Q Patien fiIteu 5 S It:ero 0 StErt DE1 End Date
FEtlent: StEtlEtlcE Fstient nufi: I
Ido Ilonth I,¡ilI,1
I ¿tltl ? - 01 rl Stltl?-tlE rl Stltl? -tl5 I
l-r"-*',rl
Ir"r-
,-,*l
I
--,*"
I
Figure 4210
Report
In
the
main menuas
Figure 43, clickthe
'Report' keyto go
intothe
patientreport menu. The patient report is
a
shortcut ofthe
latest patient searching. Theresult
of
searchingby the
patientin the
latest sendingdate is as
sameas
the patient report list.Patlent TahIe
IF"-1=*
F-r-*l tp".1*.
rr,f"lTest: Üate SaropIe I,J ar¡ e 5e>r T'lteI a
¡
z L-rtlT -tl3 - rl ! Z I ? ¿007-t:t3-r:rl J I eüü?-rt3-0s 4 3ütl?-tl3-tls tr I ¡rlrl?-tl3-tltl E 1 30t_t? - tl3 -tl g T 1 ¿rlr:tT-[3-t]S I StltlT-tl3-üs 3Ptge l-l¡ Fage Doun Select AII Frir:t Feturn
Figure 43
The module
is
usedto
search and printthe
latest patient report quickly. Thepatient
table
is
in the latest
sendingday. If there
is
no
patientin 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.
Multilinescan be
selected
to
print. And
click "Select AIl" to select all the lines in the table. If there are more than one P beforethe
line,the
patient reportwill be
printedout
continuously.The
Pwill
disappear after report was printed.Click
the
"Patient
Report"or
"Patient lnfo" key
to
view
the
report
or
theinformation of the selected patient as Figure44.
-29-ljEIÍFl-E Un. :.1- I,laue: f'EtEr :iex:Ila.Le nr_re: Iü
f t: e¡: F.rsr-rIl: Llrlit:./[r-¡a1 I,lsrüsl- Are¡
HEeA,-t 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
us¡ngthe
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
instrumentcan
be controlledby
aPC
throughthe
serial
port,us¡ng
thePCsoftware
interface,more
powerful,
easy to
connect hospital management system,if using this method, the instrument must be setas
follows: (software, see the software online help)o
Click"System
rro
Select the "PC Mode".
CIick "OK"Note: To
install
the
software, pleasecontact
the dealer or manufacturer. Setto"PC Control", the main interface on the "sample test" button will disappear.
12.2
Software Operation
Operating
systeffr:
Windows XPHardware
environment
¡
Pentium ll1350above,
memory 128M, 500M or more free hard disk capac¡ty, resolution 800 * 600 and aboveCommunication:
Seria! CommunicationCommunication lnterface:
RS232 serial portGommunication baud rate
:1920012.3
Software ser¡al
communication protocol
and code
1) Frame
format
Table 4
Frame head Sequence length PDU type Data Check
A5H 1 byte 2 bytes 2 bytes N bytes 1 byte
t
-30-Frame
head:
Because synHeader is ASH, therefore may not appear the samebyte as ASH in the other fields in a frame, in order to avoid the frame analysis
grammatical ambiguity;
if
in
otherfields
appearsAsH, then in after that
fillsagain an ASH byte. Receiver when
analysis,
meets singleAsH
byte to think itis the synHeader,
meetstwo
consecutiveAsH
byteto think
it
is
other databyte,
this time should neglect an ASH byte.Sequence:
Back end may wilfully
fill
in; front end must
fill
in
the
samesequence number rn the response frame.
Length:
The
lengthis the total
lengthof
PDUtype field and
datafield,
not including the synHeader, sequence and checkcodePDU:
SeePart2
Data:
See Part 2Check:
Single-byte XOR checksum algorithm, computation scope: sequencenumber, length, PDU type, and data.
2)
PDUtype and
data0x0001
reset0x0002
Read thefront
version0x0003
front version0x00'10
command completes and no data is returned0x0011
command to complete, but an error occurred0x0101
shake; Vibration ELISA ptate0x0102
switch the tight fitter0x0103
read theair's
AD value0x0104
AD value0x0105
ELISA test board0x0106
ABS Vatue0x0107
AD valueof
the last test0x0108
AD value0x0109
lampswitch (0
Open,
1 Close)0x010A
read lamp's state0x010B
lamp's state0x010C
read machine's lD0x010D
machine's lD-3)
Sendcommands and responses
Table 5
Type Command function
Receive /Send
Data
Expected response
Timeout Other explanations
0x0001 reset Send 0x001 0 5 seconds
After power on,use this
command
to
judgewhether the correction of coefficient is correct 0x0002 Read the front vers¡on Send none 0x0003 1 seconds
0x0003 front version Receive 4 bytes none none
0x001 0
Command comPletes and no data is returned
recelve none none none
0x0011
Command
tocomplete, but
an
error occurredrecetve two bytes none none
0x0101 Vibration ELISA Plate Send
Two
bYtesfirst
bYtels
speed Second byteis
times 0x0010 Vibration time +3 seconds Vibration SPeed :1.
slowly2.
middle3.
fast Vibration time: 1 -60 seconds0x0102 switch
the
light filter Sendone byte:
Filter number(0-7)
0x0010 3 seconds
installs seven light filters, the user can
increase two
0x0103
read
the
air's
AD valueSend none 0x0104 1 second
0x0104 the air's AD value Receive
16
bytesof
AD valuenone none
I
row
16 AD value of the air0x01 05 ELISA
test
board SendOne byte test mode
(0: continuous; 1: Step) 0x0106 Continuous: 1 Oseconds Step: 30 seconds
&
-32-0x01 06 Absorbance test Value Receive 192 bytes, 96 holes
of
the
16 absorbance value none 1 seconds192 bytes of data, all
values have expanded
1,000 times
10005absorbance said too
much 10,006 that is too small absorbance
0x0107 AD value
of
the last test Send none 0x01 08 1 secondsExecutive Directive to be tested
0x0108 AD value Receive
208 bytes, 96 holes
of the 16 AD value
+8 rows the 16 air AD
none 1 seconds
0x0109 lamp switch send
0
means open, means closed0x0010 I second
0x010A read lamp's state send none 0x01 0B 1 second
0x01 0B lamp's state recerve
one
byte: lamp's statetwo bytes: switch lamp time
none none
0x01 0C read machine's ID send none 0x010D 1 second
0x010D machine's lD recetve
nine
bytes: machine's lD none none I-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: 19200Parity: 'N'
Databits:8
Stopsbits:1
-34-IS09001&
IS013485
Certif
ied
Sinnowa
Medical
Science & Technology
Co.
,
Ltd
Acld
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Industri¿rl
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