30; the frame goes into low light, the LED light
‘source is switched off and on the video is displayed the last
parameter, entered and confirmed.
+ Following the last data entry the video displays once again the
‘please wait” frame it the instrument is in the warm up period or the
principal menu if the instrument is already warmed up.
+ Ifthe instrument is in the please wait phase the operator can enter
the utiity program (PROG) in order to check or set-up the instrument
QS esrmeratoniabrstoy prior to starting analysis.
‘tan analysis is carried out under these conditions the warning
“INCUBATION TEMPERATURE OUT OF RANGE" is displayed and
the print-out shows the relative error code.
On exit from the analysis the ‘please wait” frame is once more
displayed.
Warning Before selecting and running any type of tests please check that:
> Proper sample level is present in sample cups. Dead volume for
0.5 ml cups Is 100 pl and for 2 ml cups is 500!
+ It primary tubes are used, make sure that the quantity of blood
collected allows a filling volume within the specifications stated
by the manufacturer.
- Adequate reagent level, Dead volume for PT/FIB, APTT,
Procomplex, Hepatocomplex and CaCl,reagent cups Is'2 ml; for
‘TT, enzyme and chromogenic substrate is 0.5 mi.
Sensors
The fluidic sensors work during the incubation phase of each cycle.
‘The sampling arm moves to samples and reagents to check the effective
presence of al liquids.
Warning Do not remove the sample tray or reagent reservoirs until the
fluidic check has been completed or the cycle will be aborted.
For flags and alarms regarding sensors please refer to section 6.
Loadiist
Action I Sample ID has been selected in the Data Transmission Program
(Section 4.10: Sample ID/Batch No. Selection} during the cycle the
operator will be able to key in sample ID's or recall a loadlist already
stored in PROG Loadiist. For additional information see Section 4.1,
Before starting analysis the instrument cisplays the following frame.
GB bstuneaentaterery ‘ACL Operators Manual
Status
Action
‘The operator can select a loadlist already stored in the memory or create
anew one.
"20
SELECT LOADUST i
Note: a list of nine loadlsts is displayed in order to identity the used / not
Used lists (datestime of the last change memorized will be indicated
when the loadist is used).
‘The operator has to key in the number which identifies the loadlist and
press ENTER to confirm,
Ita loadiist already stored in the memory is selected, itis possible to
ait, and eventually change, the sample ID's memorized.
fo edit sompie 1
¥ to ston onatsis
Pressing <- to change itis possible to go back to the previous frame.
HH no changes are necessary press ¥ to start analysis.
If sample ID's have to be entered press a to edit.
If in the special programs the DATA TRANSMISSION BATCH ON
condition has been selected (see section 4,10), a 12 digit number, which
‘can be divided by decimal points, to identity the analysis rotor, can be
G2 rman tsbertny herein ®
‘This frame is displayed until the operator has confirmed a Batch No. by
keying ENTER.
CISIET
ee
Key innew value
ENTER to conta ‘ACL Operators Manus!
Warning
1f the Batch No/Loadiist is not keyed in the “resuits* fame replaces the
“batch” rame at the end of the acquisition.
{fat the end of the acquisition the operator is keying in the Batch No/
‘Sample ID there is a timeout of some minutes after the last numerical
key has been pressed.
If within this timeout the Baich No/Sample IDhas not been confirmed by
pressing ENTER, the “results” fame appears.
Notes:
+ Batch No./Sample ID are not shown on the VOU with the results but
are printed...
= At the end of any analytical cycle a 7-beep signal will advise the
operator.
Preheating Time
{As this model has no preheating in the rotor compartment, each cycle
has a fixed preheating time (135 seconds), from the sample/rotor check
to the loading, in order to guarantee correct rotor heating to 37°C.
This "Preheating phase” will be present in all analytical cycles.
(On the central part of the VDU the instrument indicates "PLEASE
WAIT", while in the upper part of it the message “ROTOR
PREHEATING" is displayed.
If Batch No/Sample ID has been selected the Batch Number/Sample ID
frame is displayed instead of "PLEASE WAIT”.
Itthe cover is opened during the preheating phase an intermittent
acoustic alarm and the message "CLOSE COVER" will signal this
situation.
On the video a question mark is cisplayed before the word results and
an error code will be presented on the printout.
( bcrunetsvontstortary 3.1. PT-Fibrinogen @
For reagent preparation and handling, piease refer to the manufacturer's
instructions included with the kit,
Status Instrument READY. The Ready state is displayed with the main menu
Isted.
The last test executed is displayed in reverse (in this description this is
referred to as the cursor).
INTR. PATHWAY
SINGLE FACTOR SPECALTESIS
‘ay toeiect
ENTER to con,
‘Action Move the cursor, by means of the & and ¥ keys, to select PT-FIB and
press ENTER,
‘The “check frame is displayed,
‘Status Indication for the usable rotor presence control.
CHECK: USABLE ROTOR PRESENCE
THROMBOPLASTIN LEVEL
REFERENCE SOLUTION LEVEL
CALDATA Gee PROG)
+ to cobvate
+ to stor onciyst
‘Action Check the usable rotor presence,
GS rsrumenatonatersory ‘AGL Operators Manca
Status
Action
Status
Action
Status
Indications for the thromboplastin level control.
Empty the thromboplastin bottle content into reservoir No.1 (MACRO) of
the instrument, marked PT-FIB.
Indications for the reference emulsion level control
Make sure that the reference emulsion level is enough (allow 1,5 om to
account for dead volume and 1-2 rotors otherwise replace the reference
bottle}.
Indication for the display of the calibration data if the instrument is
calibrated.
The message “NOT CALIBRATED" is displayed in raverse if the PT-FIB
Is not calibrated.
Action
CHECK: USABLE ROTOR PRESENCE
THROMBOPLASTIN LEVEL
REFERENCE SOLUTION LEVEL
{OT CALIBRATED
% to cabiare
+ teat analyis
Press the PROG key to display the last calibration condition and the
relative data.
By repressing the PROG key, the “check” frame is displayed.
PT Calibration
If in the “check’ frame & is pressed, a calibration cycle is initiated
Ifthe instrument is caliorated the PT-FIB last accepted calibration
analytical conditions are cispleyed. -10
Operation
Action
Status
FB LAST ACCEPTED
‘ANALYIICAL CALIBRATION CONDITIONS
NP.ID.
| FB REFERENCE VALUE (mg/a)
EF, EMULSON LOT
RROMBORASIN cot
:
CALBRATION DATE
+ fe change
+ to continue
‘The operator is ether able to check the last analytical conditions and
calibrate the instrument with the same parameters by pressing ¥ to
‘continue or change one or more data by pressing to change.
Pere LASTACCEPTED.
ANALYTICAL CAUBKATION CONDITIONS
NPD,
ib REFERENCE VALUE (mg/d)
Bez EMULSION LOT
TEROMBORASIIN Lor
CCAUBRATION DATE
Key in new value
ENTER to contim
Jf the instrument is not calibrated and a. to change has been pressed,
this frame with the first parameter in reverse is displayed.
Here it is possible to change or confirm the following parameters:
+ Normal Plasma Lot Identification Number (Calibration Plasma or
Plasma Pool)
- Normal Plasma Fibrinogen value (mg/dl)”
Reference emulsion Lot Number
+ Thromboplastin Lot Number
+ Thromboplastin ISI valve
It a Fibrinogen value of 0 is introduced, the instrument will not calibrate
the Fibrinogen.
G8 instrumentation aboratory ‘ACL Operators Manual aot
e For IL Calibration Plasma, please insert the valve written on the relative
insert sheet. The Fibrinogen value entered for the Plasma Pool must be
defined using a separate method. The acceptable range for Fibis from
£200 to 450 mg/dl.
Note: The acceptable range for ISI is 0.100 to 9.999 (see the insert
sheet included in the Thromboplastn ki).
Action The operator can confirm any parameter by pressing ENTER (if a
parameter has to be changed, ENTER must be pressed after the new
data has been entered).
‘The parameter to be confirmed or changed
isplayed in reverse.
Status After keying all the data in, the instrument tells the operator to place the
‘Norma! Plasma and Diluent in position on the sample tray (please use 2
‘mi cups for calibration; POOL and Dit. positions)
PLACE ND. IN"POOL' POSTION
e PLACE DALUENT
+ to wart onaiyss
i sma (2 mi) in postion
L" and the Sample Diluent (2 ml) in position “DIL” on the =
Y to star calibration. —
‘Status The instrument checks forthe corectpostioning of the Normal Plasma
and Sample Diluent and for the presence of a new rotor.
iby
org Action
Status
(CHECK SAMPLE TRAY
+10 ston ancives
LOAD New ROTOR
+ foster enanals e
Check sample tray. Load new rotor.
The “check” frame is displayed i, during the previous checks at the
starting of the analysis the samples are missing.
The "load" frame is displayed it, during the previous checks at the
starting of the analysis, the rotor is missing or it has been fully used.
Atterwards the instrument starts to load. The instrument dispenses
undiluted Normal Plasma (100%) and reagent in the first six cuvettes, in
the following six positions diluted Normal Plasma (50%) and reagent and
in the last six positions diluted Normal Plasma (25%) and reagent.
The instrument automatically carries out the dilutions.
The message “DO NOT OPEN COVER? is displayed on the frst line of
the video. AGL Operators Manual 3-13
(On the third line ofthe video the folowing messages are displayed in
sequence:
= "LOADING"
= INCUBATION”
~ ‘ACQUISITION"
During incubation the sampling arm with fuic sensors checks the liquid
presence.
Warning Do not remove the sample tray or reagent reservoirs until the
e fluidic check has been completed or the cycle will be aborted.
For flags and alarms related to this matter, please refer to
section 6.
‘Status In the center of the video the message “PLEASE WAIT" is displayed
until the appearance of the calibration results.
At the end of the acquisition and before the appearance of the results
the message “PLEASE WAIT FOR THE END OF CALCULATION" is
cisplayed.
GB bsriretaintatontry At the end of the calculation phase the “calibration results” frame is
displayed.
Status
rea
OVH084 FIB 240 562 CVAB.115
vise 125 834 Cva8.2E2
veo.88 63 183 cvas.48
et.000 F059
4 fos00 grants Pat to print
focontnue
By pressing PRT to print the calisration data are printed.
‘The operator can now chose between accepting the calibration or not.
He may either presses V to continue (direct way), or presses a to see
‘graphs (indirect way).
‘The calibration results are expressed in the following way: the mean
value, expressed in seconds, of the 6 cuvettes with Normal Plasma
100%, the mean of the 6 cuvettes wit Normal Plasma 50% and the
mean of the 6 cuvettes with Normal Plasma 25% and the CV
corresponding to each dilution are given.
In addition the coefficient of correlation (#) is also expressed,
‘This gives an indication of the degree of alignment of the measured
results to theoretical (a value of 1.000 represents perfect correlation).
Notes:
If during calibration “WARNINGS” display occurs giving rise to doubts
regarding the results, these warnings are indicated in the calibration
results (see section 6)
1, in spite of the warnings, the operator decides to accept the
calibration, the aporopriate error codes is memorized and printed on
the relative calibration printout and al subsequent PT-FIB analyses.
Calibration for PT-FIB is always carried out on the mean values of
the 6 determinations for each level (100%, 50% and 25%).
The following calibration errors may occur and be signalled:
2) if the average is calculated on less than 4 samples (the other two
being excessively out of range e.g. Not coagulated or coag error)
the message ‘NOT CALIBRATED “is displayed. ‘ACL Operators Manual
Status
PT ratcalrated FIB not calbrated
no Bui in POOL" poston
») If the relative coetticient of variation (CV) of a mean value is
outside the pre-established range, the CV concemed is presented
in reverse.
‘The predetermined ranges for the values of CV for PT and FIB
fae
PT Fibrinogen
NP (100%) CV< 1.5% CV <8.0%
NP ( 50%) cv<20% CV < 120%
NP (25%) cve20% Cv 120%
6) If the value of the correlation coefficient of correlation (1) is
outside the pre-established range (< 0.980) the value is presented
in reverse.
4d) If both CV and rare out of range, both are isplayed in reverse.
) In any condition the results of calibration are not memorized until
acceptance, by the operator, of their vaicty.
- PT and Fibrinogen calibrations may be accepted ifthe flagged CVs
ave less than or equal to 1.0% greater than the specifications as
stated above and the ofthe calibration curve are within acceptable
limits. ifthe ris flagged calibration shouid be repeated.
+ Should power fail occur before acceptance by the operator, then the
results are lost and the instrument presents the previous calibration
results. The resutts of a previous calibration are not substituted with
the new values until acceptance by the operator.
in the “calibration results” frame & to see graphs has been pressed,
the instrument aisplays the PT graph with the relative slope, intercept
and #.
‘Instrumentation Laboratory 116
Action By pressing PRT to print the PT graph with m, q and is printed,
‘The operator must press V to continue,
‘Status The instrument displays the Fibrinogen graph with the relative slope,
intercept and #
¢
m9
125
a= 1480
623, 20991
o's 080 oR,
“$0 continue PAT To pent
‘Action By pressing PRT to print the Fil graph with m, q and ris printed,
‘The operator must press ¥ to continue, ‘ACL Operators Manual a7
mod
Pr 100 117 Ve 0.22 FB 249 $5.2 CV=250
50 148 CV= 1.10 125 334 Cve752
2 D9 Cv= 087 #3 153 Cv=820
‘= 1.000 920.901
“F acceptante cal
+not acceptabie cal
Status Here itis possible to accept or not the calibration.
This frame can aso be reached by pressing to continue in the
“calioration results" frame.
Action Press & acceptabie cal.
By pressing PRT to print the calibration data are printed.
moi a
Pr 100 1:7 Cv= 022 FB 249 $62 Cv=250
50 166 Cve 1.10 128 33.4 Cve 752
25 29 Cv= 087 @& 153 Cva80
= 1000 80.991
to change selection
ENTER 1o conti acceptable cal
‘Status The operator is asked to confirm the acceptable cal.
Action By pressing ENTER the choice is confirmed.
Status itis possible to go back to the previous frame by pressing <- to change
selection.
Action In the calibration acoeptance frame, press W not acceptable cal
Status The operator is asked to contirm the choice.
e,
Gs rsrumeratonatorion poration
Action
0 mol
Pro 117 CVe 034 FB 269
% is Be ts
Sos Qc SG
vo Yano
‘to chonge selection
ENTER fe confem unacceptable €al
Press ENTER to confirm the choice.
Press «- to change selection to go back to the selected frame to accept
‘or not the calibration.
Notes:
- Forboth paths after ENTER, the frame retums to the main menu.
- Attar the calibration acceptance, the last calibration is replaced by the
new one.
= If there is an old calibration in the memory, a S.P. is in progress and
the operator has changed one or more analytical condition the
following situation occurs:
2) A change of N.P. ID cancels the S.P. data for PT, FIB, APTT. (if
SP. is in progress and the operator accepts the new calibration a
warning” frame is displayed).
b) A change of the FIB value updates the FIB S.P. (repositioning the
S.P. according to the new value).
©) A change of Reference Emulsion fot cancels the S.P. data for FIB
(If the relative S.P. is in progress and the operator accepts the
‘new calibration a “warning” frame is oisplayed).
@) A change of LS.l. value does not change the previous conditions
(only the calculation of .N.R. is affected).
#) A change of Thromboplastin lot cancels the S.P. data for PT and
FIB (if the relative S.P. is in progress and the operator accepts the
new calibration 2 “warning” irame is displayed).
Jn the “warning" frame the message "BEFORE PROCEEDING
REFER TO THE OPERATOR'S MANUAL" is displayed when cases
4) and/or ¢) and or €) occur.
In these three cases the operator can choose to print or not the old
SP. data.
GB rsrumentacentsbortny ‘AGL Operator's Mantel
Action
Status
Action
ATTENTION: BEFORE PROCEEDING REFER
TO THE OPERATORS MANUAL,
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