Vitalab Flexor-E Host

Appendix
A. Appendix
VITAL SCIENTIFIC N.V. A-1

Appendix
A.1 Interface Description

Data formats and transmission instructions for the communication between the analyzer-PC and a host
computer are described in the following.
A.1.1 RS-232 Description
The line signal definition is shown in the following table:
DB-25 Signal name direction remarks

pin #
7 SG Signal Ground
2 TX Transmit data output data from analyzer-PC to host
3 RX Receive data input data from host to analyzer-PC
4 RTS Request To Send output *
5 CTS Clear To Send input *
20 DTR Data Terminal Ready output *
6 DSR Data Set Ready input *
8 CD Carrier Detect input not used
22 RI Ring Indicator input not used
* function depending on the COM-port settings
A-2 VITAL SCIENTIFIC N.V.

Appendix
General remarks
The analyzer-PC uses a proprietary communication protocol to connect it to a host computer. This is a
normal RS232 serial interface protocol, and the main properties are given here.
The analyzer-PC uses handshaking according to the settings of the COM-port used for the communi-
cation with the host.
The settings of the COM-port (baud rate, start, stop and parity bits) can only be programmed in the
Analyzer Host Communication Program.
As start and stop indicators of requests and responses respectively STX and ETX are used.
No use is made of a checksum.

There is no initialization of a complete communication protocol as such. The host can simply send re-
quests for reagent positions, tests, software versions etc. The analyzer-PC will respond with the corre-
sponding answer. In order to check the communication the Echo request function can be used.
The analyzer only works in the so-called Upload mode. This means that the host sends for each indi-
vidual sample a Request Sample to the analyzer-PC, which directly responds with a Request sample
indication and after finishing the request with a Result.
In case the analyzer works with more than one reagent rotor the host must send only test requests for
the tests actually installed on the reagent rotor. The other tests for this sample can then be requested
later.
When the operator changes the reagent rotor of the analyzer, automatically a new Reagent Installation
is sent to the host, so the host knows which tests can be requested.
The hereafter mentioned [Physician_name] and [limit_flags] are only used when the corresponding
settings in the Installation – Communication – Host Communication menu of the analyzer program are
“on”.

Appendix
Message Result
Direction analyzer → host
Format STX {
R;device_id(4);
type(1);
Sample_nr(12);Sample_name(20);date_of_birth(11);sex(1);
[Physician_name(20)];nr_of_tests(2);
test_name(4);result(7);flags(22);[limit_flags(3)];units(6);
} ETX CR LF
Explanation
This message is sent automatically by the analyzer, if the tests of a sample are completed or if the op-
erator presses Ctrl-F1 in the Evaluate Samples menu, in which case a result message is sent for the
sample currently displayed on screen.
If in the Communications menu "Extended result:" is set to "yes", the extended result message is sent in-
stead of the result message.
type(1) N: Normal
E: Stat
P: Pediatric
C: Control
S: Calibrator
B: Blank
FOR CONTROL:
Sample_nr(12);Sample_name(20);date_of_birth(11);sex(1);[Physician_name(20)];
IS REPLACED BY:
Contr_name(15);Batch_nr(10);;;[;]
FOR CALIBRATOR:
IS REPLACED BY:
Calib_name(15);;;;[;]
FOR BLANK:
IS REPLACED BY:
Blank(5);;;;[;]
THE LINE
test_name(4);result(7);flags(22);units(6);
IS REPEATED FOR EACH TEST.
flags(22): see Extended result

limit_flags(3): see Extended result

Appendix
Message Extended Result
Format STX {
X;device_id(4);
type(1);
Sample_nr(12);Sample_name(20);date_of_birth(11);sex(1);
[Physician_name(20);]nr_of_tests(2);
test_name(4);result(7);flags(22);[limit_flags(3);]units(6);
reag_abs(7);raw_result(7);raw_units(6);detailed_info
} ETX CR LF
Explanation
type(1) N: Normal
E: Stat
P: Pediatric
C: Control
S: Calibrator
B: Blank
FOR CONTROL:
Sample_nr(12);Sample_name(20);date_of_birth(11);sex(1);[Physician_name(20);]
IS REPLACED BY:
Contr_name(15);Batch_nr(10);;;[;]
FOR CALIBRATOR:
IS REPLACED BY:
Calib_name(15);;;;[;]
FOR BLANK:
IS REPLACED BY:
Blank(5);;;;[;]
THE LINES
test_name(4);result(7);flags(22); [limit_flags(3);]units(6);
reag_abs(7);raw_result(7);raw_units(6);detailed_info
ARE REPEATED FOR EACH TEST.
FOR ISE TESTS:

reag_abs(7);
IS REPLACED BY:
;
For sample blank tests, the test_name(4) is upper/lowercase toggled
flags(22) see below

limit_flags(3) see below

Appendix
detailed_info for MONO MODE:

for kinetic:
K; 22 times: used_i(1); point_i(6);
for twopoint:
T; 22 times: used_i(1); point_i(6);
for endpoint monochromatic:
M; endpoint_1(6); endpoint_2(6); 42 times: ‘;’
for endpoint bichromatic:
B; endpoint_1(6); endpoint_2(6); 42 times: ‘;’
for ISE:
I; 44 times: ‘;’
detailed_info for DUAL MODE:
for kinetic:
k; 21 times: used_i(1); point_i(6); 2 times: ‘;’
for twopoint:
t; 21 times: used_i(1); point_i(6); 2 times: ‘;’
for endpoint monochromatic:
m;
used_r_abs_1a(1);endpoint_abs_1a(6);
used_r_abs_1b(1);endpoint_abs_1b(6);
used_ep_1a(1);endpoint_1a(6);
used_ep_1b(1);endpoint_1b(6);
38 times: ';'
for endpoint bichromatic:
b;
used_r_abs_1a(1);endpoint_abs_1a(6);
used_r_abs_1b(1);endpoint_abs_1b(6);
38 times: ‘;’
for ISE:
I; 44 times: ‘;’
used_i(1) 0: point_i not used

1: point_i used for computation

Appendix
Flags
These flags appear in a fixed order in a string. For every flag either a space is written or the respective
flag. If none of the flags is true a string is sent with 22 spaces.
pos. flag error

1 G general hardware error
2 R insufficient reagent
3 # insufficient sample
4 L lamp error/ISE electrode not calibrated
5 U underrange/underrange ISE electrode
6 O overrange/overrange ISE electrode
7 u underrange reference counter/underrange reference ISE electrode
8 o overrange reference counter/overrange reference ISE electrode
9 T cuvette temperature error/ISE temperature error
10 r rerun
11 * non linearity error
12 M absorbance limit violation
13 D reagent absorbance deviation error
14 W westgard violation
15 A calibrator limit violation
16 C control limit violation
17 N reference limit violation
18 a reagent absorbance limit violation
19 I general ISE unit error
20 X concentration limit error
21 P prozone error
22 E result near cut-off
Limit flags
These flags appear in a fixed order in a string. For every flag either a space is written or the respective
flag. If none of the flags is true a string is sent with 3 spaces.
pos. flag error

1 H high limit
2 L low limit
3 P panic

Appendix
Message Reagent installation
Format STX {
I;device_id(4);
test_name(4); (32 times)
} ETX CR LF
Explanation
This message is sent (automatically) by the analyzer-PC, when the operator has changed the reagent in-
stallation, the run mode or the reagent disk (menu).
For sample blank tests, the test_name(4) is left blank.

Appendix
Message Blank result
Format STX {
B;device_id(4);
wavelength(3);
cuvet_blank_val(6); (48 times)
cuvet_av(6); cuvet_sd(6);
lamp_av(6); lamp_sd(6);
} EXT CR LF
Explanation
This message is sent by the analyzer when the operator presses Ctrl-F1 in the Rotor/System/ISE - Blank
Rotor menu.

Appendix
Command Echo request
Direction host → analyzer
Format STX {
E;
} ETX
Response STX {
e;device_id(4);
status(1); } ETX CR LF
Explanation:
status(1) 0: success
7: failed: message length error
8: failed: overrun error
9: failed: parity, framing or break error
This message can be used as a test feature.

Appendix
Command Get software version
Format STX {
V;
} ETX
Response STX {
v;device_id(4);
status(1);software_version(6..18);
} ETX CR LF
Explanation:

Appendix
Command Get reagent installation
Format STX {
I;
} ETX
Response STX {
i;device_id(4);
status(1);
test_name(4); (32 times)
} ETX CR LF
Explanation:
For sample blank tests or uninstalled tests, the test_name(4) is left blank (4 spaces).

Appendix
Command Get reagent test counters
Format STX {
N;
} ETX
Response STX {
n;device_id(4);
status(1);
reagent_test_count(5); (32 times)
} ETX CR LF
Explanation:
For sample blank tests or uninstalled tests, the reagent_test_count(5) is set to 1.

Appendix
Command Request sample
Format STX {
Q;
Sample_nr(1..12);
type(1); Sample_name(0..20);date_of_birth(0..11);sex(1);
[Physician_name(0..20);]
request_tests(1..32);
} ETX
Response STX {
q;device_id(4);
status(1);
Sample_nr(12);type(1);Sample_name(20);
date_of_birth(11);sex(1);[Physician_name(20);]
request_tests(32);
} ETX CR LF
Explanation
Sample_nr(1..12) May contain the characters 20H..7eH except 3bH (;), but may not start with 20H
(space)
type(1) N: Normal
E: Stat
P: Pediatric
Sample_name(0..20) May contain the characters 20H..7eH but may not start with 20H (space)
date_of_birth(0..11) Must have the same format (European or American) as programmed in the
system parameters. As separators might be used:
20H..2fH, 3aH, 3cH..40H, 5bH..60H, 7bH..7eH
Valid European Values are:
1.3.92, 01/03/1992, 1:3:92, 1|Mar|1992
Valid America values are:

3.1.92, 03/01/1992, MAR 1 92, 3:1:92, Mar|1|1992
sex(1) M: Male
F: Female
P: Pediatric
request_test(1 .. 32) a row of at most 32 ‘0’ or ‘1’,

0: don't request the test
1: request the test
(Sample blank tests are internally in the analyzer (but not in the indication)
automatically set to 1 if appropriate).
If one or more Na, K or Cl tests are selected, the analyzer will measure all three
and will send all three results.

Appendix
status(1)
0: success: request created or tests added to existing request with the same sample num-
ber etc.
1: failed: sample number already exists, but demographic information doesn’t match, or
request in use by the operator
2: failed: no space for request
3: failed: one or more tests requested, which have not been installed

Appendix
Command Delete request sample
Format STX {
D;
Sample_nr(1..12);
} ETX
Response STX {
d;device_id(4);
status(1);
Sample_nr(12);
sample_info
} ETX CR LF
Explanation:
1: failed: sample number not found, already loaded or in use by the operator
sample info (only present if status is 0):
type(1);
Sample_name(20);date_of_birth(11);sex(1);
[Physician_name(20)];

Appendix
Command Ask sample result
Format STX {
R;
Sample_nr(1..12);
} ETX CR LF
Response STX {
r;device_id(4);
status(1);
Sample_nr(12);
sample_info
} ETX CR LF
Explanation
status(1)
0: success: (sample ready or unloaded)

1: success: (sample loaded or still in process)
2: failed: sample number still in request buffer (not yet loaded)
3: failed: sample number not found
sample info (only present if status is 0 or 1):
type(1);
Sample_name(20);date_of_birth(11);sex(1);
[Physician_name(20)];nr_of_tests(2);
type(1) N: Normal
E: Stat
P: Pediatric
THE LINE
IS REPEATED FOR EACH TEST.
If the result is not yet ready it is blank (‘’).
flags(22): see Extended result

limit_flags(3): see Extended result

Appendix
A.2 "988-VS" ISE (Option)

A.2.1 ISE Unit
The ISE unit is a fully automatic microprocessor controlled analyzer that is used to measure the following
+ + -
parameters: sodium (Na ), potassium (K ) and chloride (Cl ).
The sample is pipetted by the sample arm into a cuvette of the analyzer, where it is diluted with ISE dilu-
ent. The pre-diluted sample is then taken out of the cuvette by the ISE needle and transferred to the ISE
unit for measuring.
After the measurement the corresponding results are sent to the analyzer, where they are printed out on
a printer or displayed on the screen.
The ISE unit is connected to the analyzer via a data transmission cable (serial interface RS 232 C) and
via a sample and waste tubing. The ISE is entirely controlled by the analyzer unit.
A separate main plug (back of the device) is used for the power supply.
The current state of the ISE is shown by the dot-matrix display (at the front of the unit).
The following reagents are part of the ISE unit: reference solution, standard A, standard B.
In addition, the following reagents, positioned on the analyzer, are required for the operation of the ISE
unit: Na-conditioner, diluent, deproteinizer and human serum.
Order numbers:
Vital AVL MERCK Description (contents)

3203-027 BP1822 107837 ISE-Diluent (12 x 25 ml)
3203-024 BP1823 107821 Standard A (3 x 430 ml)
3203-025 BP1824 107822 Standard B (3 x 90 ml)
3203-026 BP1825 107830 ISE-Reference Solution (3 x 90 ml)
3203-029 BP1827 107839 Na+ Electrode Conditioner (125 ml)
3202-012 BP1828 107685 ISE Calibrator (30 Ampoules x 1.8 ml)
3203-030 BP1849 107844 Deproteinizer (125 ml)

Appendix
The electrode compartment of the ISE contains the ISE-Specification

reference solution. The solution is pumped into the Parameter:
+ +
Na -K -Cl
–
reference electrode and forms a salt bridge be- Sample types: Serum or plasma
tween the calomel electrode and sample by means Sample volume: 25 µl (+225 µl diluent)
of the tubing pump. Measuring Range: Na 5.0 – 20.0 mmol/l
Standard A is used as a washing solution and for (1 + 9 diluted) K 0.05 – 1.0 mmol/l
setting the first calibration point. Standard B is Cl 5.0 – 16.0 mmol/l
used for setting the second calibration point. Precision (series): Na CV < 1.5%
The deproteinizer is used for periodical removal of K CV < 1.5%
impurities and for cleaning the electrodes. The ISE Cl CV < 1.5%
activator (human serum) is used to keep the sur- Precision (day/day): Na CV < 3.0%
face membrane functioning fully during the auto- K CV < 3.0%
matic cleaning procedure. Cl CV < 3.0%
The sodium electrode is conditioned after a
deproteinize action by means of the sodium-
electrode conditioner.
All samples are pre-diluted (1 + 9) with ISE diluent
in the cuvette rotor before measurement.
ISE Specification (cont.) Reagents and electrodes can be accessed by

Display: dot-matrix, 20 digits opening the cover of the ISE. The cover protects
Cleaning: automatic the electronic devices from stray radiation. When
Calibration: automatic, 2 point opening the cover, an acoustic signal can be
Interface: serial, RS 232 C heard.
Operating temp.: +10 °C to +32 °C
lf the cover remains open for longer than 30 sec-
Humidity: 5% to 85%
onds, the message "Not calibrated" is shown on
Line voltage: adjustable
the display and an automatic calibration process is
100 V / 117 V / 220 V
started once the cover is closed.
50 / 60 Hz
Power consumption: 60 VA max.
Dimensions (mm): 345 (W), 270 (H), 300
(L)
Weight: 11.3 kg

Appendix
A.2.2 Operating Prerequisites
The analyzer and ISE unit are forwarded in a transport box and have to be unpacked and installed by a
service technician. On location, the system will be inspected and handed over to the user ready for op-
eration.
The device is designed for operation in closed rooms only. It must be placed on a flat, horizontal surface
that is not subject to vibrations.
Note
The customer is not allowed to unpack the devices or accessories. Only trained service person-
nel is allowed to the install the system. Should this not be observed, the manufacturer does not
accept any responsibility for damages and/or improper operation of the device that may result.
o o
Avoid exposure to direct sunlight. The ambient temperature should lie between 10 C and 32 C. The
o
maximum relative humidity must not exceed 85% at +32 C (no vapour). The device is rated Pollution
Degree 2, in accordance with IEC 664. lt can be operated up to the maximum height of 3000 m above
mean sea level.
To replace the fuses: pull out the fuse socket with the mounted fuses. Then remove the fuses. The fuse
socket is located under the line voltage socket on the back of the device. Only replace fuses with suitable
new ones. Then reinsert the fuse socket into its position. The mains connector should have a solid ground
connection to ensure safety and trouble-free operation of the analyzer.
The line connection has to be grounded according to common regulations, to ensure proper operation of
the system.
Please be advised that this medical equipment complies with the requirements of the applicable EMC
standards. Electronic equipment exceeding the radiation limits defined in EMC standards, such as GSM
and other handheld mobile equipment, may affect the working of our equipment.
Note
The ISE unit should be switched on at all time. If the device is switched off for a period of 8
hours or longer, a shutdown procedure should be performed.
In addition, optimum operation conditions may only be guaranteed for the ISE unit, if the following re-
quirements are fulfilled: only the prescribed reagents are allowed for use. The reagents must be used in
accordance with the defined requirements (see application instructions). A quality control must be per-
formed regularly.

Appendix
A.2.3 Setting up the ISE parameters
Press F5 Special Funct and F2 Installation to access the ISE PARAMETERS menu. ISE PARAME-
TERS must then be selected using the cursor keys and confirmed by pressing Enter. Normally, adjust-
ments in this menu need to be defined only once (before the ISE goes into operation).
Function of ISE parameters
Electrodes Displayed are the installed electrodes. If a dummy electrode is inserted

- + +
for the Cl electrode, only Na and K may be selected.
Autom. ISE deprot.time A daily deproteinizing (cleaning) process will automatically be performed
for the ISE-unit at the time entered here. The entry is made in the 24-hour
mode. Cleaning time is approx. 20 min. Photometric tests can be carried
out as usual during the cleaning cycle. It is recommended that the time
entered here, at which the cleaning process is performed, be set for just
before or after the daily routine.
Max. ISE standby time The time entered here determines after how many minutes an automatic
measurement with ISE-activator (human serum) is initiated before the
next regular ISE measurement is performed. A time setting of 60 minutes
is recommended. (So if in 60 minutes no ISE measurement has been
performed and an ISE measurement has been requested, the ISE acti-
vator will be measured first.)
Setting of ISE parameters
When INSTALLATION/ISE PARAMETERS is Setting ISE parameters

called up for the first time, select the first field, Electrodes:
+ +
Na K Cl
-
Electrodes, by pressing the Tab key. After press- Autom.ISE deprot.time: 18:30
ing Enter, a selection window is opened up, where Max. ISE standby time: 60 min.
+ + -
you can make a choice between Na K Cl and
+ +
Na K . Depending on the installed electrodes you
can make a choice. If a dummy electrode is in-
- + +
serted for Cl , only Na and K may be selected.
A time may be entered in the field Autom. ISE deprot.time, at which the system automatically performs
the required ISE cleaning with deproteinizer (18:30 as in our example). We recommend you to program a
time which is close to the end of the day routine while the proteins are still fresh. Confirm the entry with
Enter. This procedure is only performed if ISE and analyzer have been switched on. Please note that the
deproteinize time is about 20 minutes. It is recommended to enter a time here that will not interrupt the
daily routine. Moreover, within a run, precision of the ISE results may vary a little when the automatic
deproteinize time falls between measurements.
Enter the recommended value 60 minutes in the Max. ISE standby time field. If the ISE-unit is switched
on, the analyzer performs an automatic measurement with the ISE activator (human serum) in the speci-
fied intervals before the next regular ISE-measurement is performed.
After setting the ISE parameters you can return to the selection menu by pressing Tab.

Appendix
A.2.4 ISE checklist for routine operation
The following details must be observed before routine operation can be started:
3 Are all cables correctly connected to the Voltage cables, tubing to cooling unit and ISE
analyzer? unit, transmission lines to ISE unit etc.
3 Is the system switched on? The analyzer, ISE unit and cooling unit: all
switches "On".
3 Are all necessary (ISE) parameters de- Run mode, language, date, time, external
fined? printer and host connection (if applicable).
3 Is the liquid system filled with system liq-

uid?
3 Were all work helps set as required? Increase of sample number, automatic rerun,
automatic result evaluation, automatic cuvette
rotor blank, profiles.
3 Were all necessary test parameters pro- Photometry and ISE.

grammed?
3 Are all reagents correctly positioned, and Reagent rotor and ISE reagents.
refilled?
3 Were all required test controls defined?
3 Were the incompatible tests defined? Some Clinical chemistry tests can interfere
with the ISE-measurements. Set incom-
patibilities if interferences are expected.
(e.g. some Magnesium (Mg.) reagents have
a negative effect on ISE-measurements).
3 Has the cuvette rotor blank been carried

out?
3 Is a sufficient amount of system liquid in

the system?
3 Was the waste container emptied?
3 Was formation of foam avoided during

reagent preparation?
3 Was formation of foam avoided during

sample preparation?

Appendix
A.2.5 ISE maintenance
The analyzer and ISE unit do not have to be checked manually each day, i.e., all maintenance measures
have only to be carried out periodically or whenever necessary. However, specific requirements should
be checked daily, to avoid unnecessary interruptions of the routine. The necessary maintenance proce-
dures are described in the maintenance check. A detailed description of the single measures is given on
the following pages.
Maintenance check ISE unit
3 What has to Interval What you have to do

be checked
3 Reagents Daily Check the filling level of the reagents in the ISE unit and on the
reagent rotor of the analyzer. Replace the bottles when neces-
sary. Never refill the containers for the standard and refer-
ence solutions, but replace the bottles if required. The ISE
activator has to be placed on position P6 of the sample rotor.
Never use the deproteinizer and conditioner for longer then
two days when transferred into the "Selectra" bottles.
Never use glass bottles for the Na-Conditioner.
3 Removing of Auto- The analyzer cleans the ISE electrodes and tubes automatically,
proteins matically either once a day or after 50 ISE measurements.
3 Cleaning of the Every The menu item ISE HALF MONTHLY MAINTENANCE (RO-
ISE unit two TOR/SYSTEM/ISE menu) must be performed twice a month.
weeks This includes the cleaning of the reference housing.
3 Tubes of the Every The tubes of the peristaltic pump must be replaced once every
peristaltic pump six six months. This is done via the menu item ISE HALF YEAR
months MAINTENANCE (ROTOR/SYSTEM/ISE).
3 Replacing of Annually All tubes of the ISE unit must be replaced once a year. This is
tubes (only by done by trained service personnel.
service tech-
nicians)
3 Manual Elec- When If unusual or imprecise results are measured after calibration,
trode mainte- neces- the electrodes can be cleaned by starting a deproteinize, condi-
nance sary tion and rinse cycle.
3 Replacing of When If unusual or imprecise results are measured after calibration,

electrodes neces- which cannot be otherwise explained (e.g. contamination of the
sary ISE unit as result of missing maintenance operations), the elec-
trodes should be changed.

Appendix
Halfmonthly Maintenance of ISE Unit
The reference housing must be cleaned to remove contamination twice a month, in particular protein pol-
lution. For this purpose, select the SPECIAL ISE FUNCTIONS menu (ROTOR/SYSTEM/ISE menu), po-
sition the cursor on the menu item ISE HALFMONTHLY MAINTENANCE and press Tab or Enter. The
screen displays the different steps to be taken for the maintenance.
Open the front cover of the ISE unit. Remove the bottle with reference solution from its clamping fixing
and unscrew the cap. Exchange the bottle with reference solution with an empty bottle, screw the cap
tightly on the empty bottle and place it into the correct position. An empty bottle is part of the range of
supply; nevertheless, an empty reference solution bottle can also be used. Press F1 to empty the meas-
urement chamber. Unplug the cable of the preamplifier and open the left locking device by pulling the
lever in forward direction. Remove the reference electrode from the measurement chamber and discon-
nect the tubes from the nipples of the electrode.
Hold the opening of the housing in upward direction to prevent spillage of the KCL solution and unscrew
the calomel electrode from the reference housing. Then place the calomel electrode on a clean and soft
tissue. The housing must be emptied and cleaned thoroughly using plenty of distilled water afterwards.

Appendix
Now put the pre-cleaned reference housing into a bleaching bath of deproteinizer or Sputofluol.
The housing should remain in the bath for approximately 15 minutes. After the time is over, take out the
housing with an appropriate tool (e.g. tweezers) and rinse it using plenty of distilled water. Be sure to
clean the capilair also using some deproteinizer (e.g., by means of a pipettor). The housing must be dried
with a tissue afterwards.
Now screw the calomel electrode into the cleaned housing and make sure that the 0-ring is correctly in
place. Connect the tubes to the corresponding nipples of the reference housing (yellow marking!). Push
the measurement electrodes as far as possible to the right and install the reference electrode into its posi-
tion. Please make sure that all 0-rings are present between the measurement electrodes. Then fix the left
locking device by pushing the lever backwards. The electrodes are now correctly installed. Plug the refer-
ence electrode cable into the preamplifier and replace the used bottle by a bottle filled with reference so-
lution. Finally, press F1 to empty the measurement chamber. Perform an internal 2-point calibration by
pressing SPECIAL ISE FUNCTIONS/ISE 2-POINT CALIBRATION and F2 in sequence. Operations may
then be carried out as usual.

Appendix
Half Year Maintenance of ISE Unit
The tubes of the peristaltic pump should be replaced every half-year. For this purpose, select the SPE-
CIAL ISE FUNCT. menu (ROTOR/SYSTEM/ISE menu), position the cursor on the menu item ISE HALF
YEAR MAINTENANCE and press Tab or Enter. The screen displays the different steps to be taken for
the maintenance (see below).
Open the front cover of the ISE unit. Remove the bottle with reference solution from its clamping fixing
and unscrew the cap. Exchange the bottle with reference solution with an empty bottle, screw the cap
tightly on the empty bottle and place it into the correct position. An empty bottle is part of the range of
supply; nevertheless, an empty reference solution bottle can also be used.
Note
After tube replacement, deproteinizing or when the ISE unit is new, some sample detection er-
rors might occur occasionally. This is caused by insufficient coating of the tubes by proteins.
After 40 - 50 samples these errors will disappear.
Press F1 to empty the chamber. Then press the pump stirrup to the left until the fixing button locks with
an audible snap.
Before you pull off the old tubes, hold the new set of tubes next to the old one to see which of the tubes
and nipples fit together. Pay attention to the order of the tubes. Disconnect the tubes from the right side of
the nipples and connect them to the nipples of the new tubing set, tube by tube. After all four tubes have
been exchanged, stretch the new set of tubes around the pump rollers.
Ensure that the tubes are not crossed-over.

Appendix
Now pull out the fixing button, so that the stirrup returns on to the rollers. Replace the empty bottle with a
bottle filled with reference solution and place it into position (tightly screw the cap).
Finally, press F1 to empty the chamber. Operations may then be carried out as usual.
Manual electrode maintenance
The ISE electrodes can be maintenanced manually, when necessary. For this purpose, select to the
SPECIAL ISE FUNCT. menu (ROTOR/SYSTEM/ISE menu), position the cursor on the menu item ISE
MANUAL ELECTRODE MAINTENANCE and press Tab or Enter. Press F1 to start a depro-
teinize/condition/rinse cycle. Manual electrode maintenance should be carried out when the ISE cannot
be calibrated and the life expactancy has not elapsed.
Exchanging Electrodes
Depending on the intensity of use, the measurement electrodes must be replaced from time to time. The
procedure is identical to that of the first installation of the electrodes.
The moment for exchanging the electrodes (please check the guaranteed operating life) depends primar-
ily on the intensity of use. However, the electrodes should be replaced if they cannot be calibrated at the
latest (after the function MANUAL ELECTRODE MAINTENANCE was carried out).

Appendix
A.2.6 Calibration of the ISE Unit
A two-point calibration is automatically performed by the system on both internal standard A and B solu-
tions during normal operation, every 6 hours (or after a cleaning cycle). The results are automatically
printed out by a connected printer. When necessary, the calibration can also be requested manually in
the SPECIAL ISE FUNCTIONS menu.
This menu is activated in the SPECIAL FUNCTIONS/ROTOR/SYSTEM/ISE/ISE menu.
Last ISE calibration date Date and time of the last ISE two-point calibration are displayed. The
and time corresponding results are listed below. The results of the calibration are
automatically printed out by a connected printer.
Standard-A This column states for each electrode (sodium, potassium, chloride) the
electrode voltage values for standard A with the number of calibration
repetitions. The minimum number of repetitions is 3; the maximum num-
ber 6. No data is displayed if one of the ion-selective tests was not pro-
grammed.
Should variations occur in the measurement cycle, the measurement is

repeated up to 6 times until a useful value is obtained.
Difference A-B This column displays for each electrode (sodium, potassium, chloride) the
differences between the electrode voltages for standard A and B. In case
of chloride the difference is always negative
Status of calibration If the calibration is not valid for one of the three parameters, FAILED is
displayed behind the difference A-B for the related test
Pump speed The displayed value must be between 9 and 12. The pump speed is
automatically adjusted by the ISE-software to compensate for variations
in tube diameter.
Flow speed The flow speed is displayed in millilitre per minute (ml/min) for each cali-
bration of standard A. Normal values lie between 0.9 and 1.1 ml/min.
Key Occupancy
Tab/Enter The function keys F1 and F2 are activated by pressing Tab or Enter.
F1 Print Cal. Res After pressing this key, the system prints the results of the last ISE cali-
bration by a connected printer.
F2 Calib. The ISE twopoint calibration is started with F2.

Appendix
Deproteinizing and Conditioning of ISE Unit
The combined deproteinize/condition/rinse procedure is automatically performed if the following require-

ments are fulfilled:
1. After 50 ISE measurements, or
2. each 24 hours at the predefined time (in the SYSTEM PARAMETERS menu)
The cycle is necessary to remove protein deposits in the measurement chamber, to condition the sodium-
electrode on a regular basis and to reduce long term pollution in the tubes.
lt is automatically followed by a two-point calibration. The cycle can also be started manually by pressing
F1 in the SPECIAL ISE FUNCTIONS/ MANUAL ELECTRODE MAINTENANCE menu.
This menu is activated by calling up the SPECIAL FUNCTIONS/ ROTOR/ SYSTEM/ISE/ISE menu.
It is advised to run this cycle manually only in case of problems with the ISE unit.
Performing the combined clean/condition/rinse cycle too often may cause damage to the electrodes.
Key Occupancy
F1 Deprot. CondRns The combined deproteinize/condition/rinse cycle is started by pressing

F1. First, however, ISE deproteinizer and ISE conditioner must be placed
on the reagent rotor in the positions displayed on the screen. Additionally
the ISE activator (human serum) has to be placed on position P6 of the
sample rotor.

Appendix
A.2.7 Error Messages
The analyzer will indicate an error occuring on the ISE unit with the message ”ISE UNIT ERROR”.
Refer to the display on the ISE unit for further guidance. Errors related to the analyzer itself are indicated
as described below:
E140 ISE NOT PRESENT
Cause: This alarm will be generated when the electric connection to the ISE unit is interrupted.
Solution: Press F4 (Acknow. Mess.). If the error occurs again, check if the connection cable is con-
nected correctly and/or if the ISE unit is switched 0ff.
E142 ISE COMMUNICATION ERROR
Cause: This alarm is generated in case of an RS 232-error (overrun/parity/framing error), or when

the result is not received within a certain time frame (time out error).
Solution: Press F4 (Acknow. Mess.)
W143 ISE RESET ACTIVE

Cause: This alarm can occur during the start-up procedure, indicating that the ISE unit is not yet
ready for operation. This alarm is usually accompanied by one or more other error mes-
sages.
E144 ISE ARM ERROR
Cause: This alarm is activated when the ISE arm is in a wrong position during a status check.
E145 ISE NOT READY
Cause: This alarm is generated when the analyzer is started up, and the ISE unit has not yet fin-
ished its startup procedure (e.g., is still warming up).
Solution: Press F4 (Acknow. Mess.) when the ISE unit is ready for operation.
W141 ISE SYNCHRONIZATION ERROR

Cause: This alarm is activated, when a request to measure a sample is sent, but the ISE unit is still
measuring. This may only occur when a measurement mistakenly takes longer than in-
tended.
Solution: Press F4 (Acknow. Mess.) The result will be flagged with an "1"

Appendix
A.2.8 Installation / Shutdown of ISE Unit
After the ISE unit has been unpacked and located in a place that meets all requirements, the following
steps should be performed to make the unit ready for operation. First check the device and the accesso-
ries and make sure that they are complete and undamaged.
The contents can be checked by means of the Location Requirements

supplied packing list. If parts are missing inform o
Temperature: +10 C - +32 C
o
your representative. In case of damage you should Humidity: max. 85%

immediately inform your carrier. Location: flat, solid, approx. 20 cm of
Keep the device and the packing material stored free space
until any queries are addressed. To avoid: direct insulation, vibrations,
electromagnetic fields, ag-
The analyzer must be switched on. Press F5 to
gressive gas and vapour
activate the SPECIAL FUNCTIONS menu.
Then press F1 ROTOR/SYSTEM/ISE and position
the cursor on the menu item ISE. Press Enter.
Select the ISE INSTALLATION function in the
SPECIAL ISE FUNCTIONS menu. Press Enter.
Use the keys PgUp and PgDn to scroll through the
pages.
The screen summarizes the different steps to be taken for the installation. Please follow the displayed in-
structions and the procedure described below.
Installation of Tubes
Magnetic Valve – Relief Clamps
Pull off the front cover carefully and remove the red relief clamps (pull away the armature of the magnet)
from the valves. Do not dispose the relief clamps since they will be used for shutdown.
Peristaltic Pump Tubes
Pull the entire pump stirrup with two fingers to the left until the fixing button clicks into place.
Fix the lower nipple correctly. Put the pair of tubes around the rollers (do not cross them). Fix the upper
nipple and pull the fixing button.

Appendix
Installation of ISE Reagents
Standard A Unscrew the cap of the standard A bottle and be sure to remove the alu-
minium foil completely. Do not contaminate the solution with your fingers
or otherwise.
Screw the cap with the long tube on to the standard A bottle. When the
cap is screwed on to the standard A bottle, the tube should touch the
bottom of the bottle.
Standard B Unscrew the (red) cap of the standard B bottle and make a whole in the
center of the aluminium foil. Do not contaminate the solution with your
fingers or otherwise.
Screw the red cap of the device onto the standard B bottle and put it into
the labelled position (on the higher level to the right of the standard A
bottle).
Reference Solution Unscrew the cap of the reference solution bottle and remove the alumin-
ium foil completely.
Avoid any kind of contamination when removing the foil, i.e., screw
the cap of the reference electrolyte container in the device on to the bottle
and put it into the labelled position behind the electrodes. Make sure that
the connecting tubes of the container cap run in the direction of the refer-
ence electrode. Do not bend the tubes. When the cap is screwed on to
the reference bottle, the tube should touch the bottom of the bottle.

Appendix
Installation of Electrodes
Reference Electrode Take the reference electrode housing out of its packing and check if the
O-ring is present. Take the calomel electrode with its red transport hous-
ing out of the packing and then remove the (red) transport housing.
Please wash the transport housing with destilled water and store it for
later maintenance and shutdown.
Screw the calomel electrode into the reference electrode housing. Con-
nect the yellow-marked tube to the yellow-marked nipple and the un-
marked tube to the unmarked nipple.
Plug the electrode cable into the socket labelled "Ref" in the preamplifier.
Measurement Electrodes The electrodes must be positioned as follows from the left to the right:
+ + -
(Na /K /Cl ) reference, sodium, potassium and chloride electrode. Open the locking
device by pushing the lever forwards with the left hand and insert the
+ +
electrodes with the right hand. The Na electrode first, then the K elec-
-
trode and finally the Cl electrode. Make sure that an O-ring is correctly
positioned between each electrode housing. Correctly inserted electrodes
can be turned slightly (about 1 mm). Finally, close the locking device by
pushing the lever backwards.
Plug the cables of the Na/K/Cl electrodes into the matching sockets of
the preamplifier until they click into place with an audible snap. The sock-
ets are marked accordingly.
Note
Attention! Do not touch the metal contacts.
Plug the GND-Temp cable into the matching socket until it clicks into
place with an audible snap.
Close the cover of the ISE unit.

Appendix
Connection to the analyzer
Connect the interface cable to the matching connector on the back of the ISE unit and tighten the screws.
Connect the sample and waste tubes to the corresponding nipples on the analyzer.
Note
Never change the length of the sample tubing! The length is exactly specified to guarantee
proper functioning of the pump and the sampling system. If any changes are made, proper
functioning of the system and correctness of the results cannot be guaranteed.
Installation of ISE Waste Tube
The waste of the ISE unit is transported via a waste tube to the waste container of the analyzer. An extra
waste nipple is mounted at the rear panel. Connect the tube marked 1513-002 (part of the range of sup-
ply of the analyzer) to this nipple. Then remove the black cap on the extra nipple on the waste container
inlet and connect the other end of the waste tube to this nipple.
Removal of Needle Protecting Block
Before the ISE unit can be used, the small protecting block, which is mounted underneath the ISE needle
on the cuvette rotor of the analyzer, must be removed first. This block prevents the needle from going
down into the cuvette rotor during measurement of photometric tests.
When removing the protecting block, ensure that no tests are being processed on the analyzer.

Appendix
Switching on the ISE Unit
Prior to the first installation, it must be checked if the indicated voltage value of the voltage selector corre-
sponds to the mains voltage in your laboratory. If this is not the case, please pull out the block near the
main switch and replace the fuse by the correct type. Use the following types only:
For 110 - 117 Volt range: 3.15 AT (slow-blow)

For 220 - 240 Volt range: 1.6 AT (slow-blow)
Then flip the power switch on the back of the ISE module. Select SYSTEM RESET in the SPECIAL ISE
FUNCTIONS (SPECIAL FUNCTIONS/ROTOR/SYSTEM/ISE) menu and press F1.
The following procedures are carried out automatically:

Initialisation
Warm up (180 seconds)

Message "Not Calibrated"
Two-point calibration, automatically requested by the analyzer (time: 360 seconds)
To guarantee proper functioning of the system, the following reagents are already pre-programmed on
the program disk of the analyzer:
ISE diluent
ISE Deproteinizer
Sodium-electrode conditioner
All further operations such as test programming, programming of ISE calibrators, automatic ISE depro-
teinize time and positioning of reagents are described in the respective chapters.
The following requirements must be fulfilled to guarantee correct functioning of the ISE unit:
Electrodes are installed (reference, sodium, potassium, chloride)
Reagents are positioned in the ISE unit (reference solution, standard A, standard B)
Protecting block of the needle is removed from analyzer.
Reagents are positioned on the reagent rotor and in the

SPECIAL FUNCTIONS/INSTALLATION/REAGENT POSITION menu (ISE diluent, ISE deproteinizer,
ISE conditioner)
ISE test programming and calibration programming

(SPECIAL FUNCTIONS/PROGRAMMING/TEST PROGRAMMING menu)
Automatic ISE deproteinize time in the

SPECIAL FUNCTIONS/INSTALLATION/ISE PARAMETERS menu.
ISE-Stand-by time
SPECIAL FUNCTIONS/INSTALLATION/ISE PARAMETERS menu.

Appendix
Shutdown Procedure
The shutdown procedure has to be performed every time the ISE unit is switched off for a period longer
than 8 hours. Otherwise the electrodes will be damaged and the tubes will be obstructed or crimp
together. Prior to the shutdown, bottles with ISE diluent and ISE deproteinizer must be present in the
programmed positions on the reagent rotor. The programming of the positions can be checked in the
SPECIAL FUNCTIONS/PROGRAMMING/TEST PROGRAMMING menu.
Select the ISE SHUTDOWN function in the SPECIAL ISE FUNCTIONS menu (ROTOR/SYSTEM/ISE)
and press F1 (Shut Dwn). Please follow the instructions displayed on the screen.
1. Remove all reagent bottles (standard A, standard B, reference solution) from the ISE unit.
2. Empty all bottles and reinsert them afterwards.
3. Confirm the insertion of the bottles by pressing a key and wait until the pump stops.
4. Remove the calomel electrode as follows: first, push the lever of the left locking device in forward di-
rection and take out the reference electrode. Then screw the calomel electrode out of the reference
electrode housing and screw it into the transport housing filled with reference electrolyte. Screw the
transport housing with the calomel electrode back into the reference electrode housing and reinstall it
into the measurement chamber.
5. Again remove all bottles from the ISE unit
6. Refill them with distilled water to approximately 1/4 filling level.
7. Confirm the refilling of the reagent bottle by pressing a key and wait until the pump stops.
8. Again remove all bottles and empty them.
9. Confirm the emptying by pressing a key and wait until the pump stops.
10. Insert the red relief clamps underneath each magnetic valve (A, B, V, S).
11. Push the stirrup of the peristaltic pump with both hands to the left until the fixing button clicks into
place. Remove the tubes from the rollers (not from the nipples) and pull the fixing button.
12. Now remove the reference electrode and unscrew the transport housing from the reference housing.
13. Empty the reference housing from liquid residues and rinse it inside with plenty of distilled water.
14. Finally, switch off the ISE unit and pull off the main plug.
Note
To restart the ISE unit, select the menu item ISE INSTALLATION (SPECIAL FUNCTIONS/RO-
TOR/SYSTEM/ISE/SPECIAL ISE FUNCTIONS menu). Please follow the instructions given in
this chapter.

Appendix
ISE Stand Alone
The ISE STAND ALONE function (SPECIAL FUNCTIONS/ROTOR/SYSTEM/ISE/SPECIAL ISE FUNC-

TIONS menu) is used to disconnect the ISE unit from the analyzer. The unit is then controlled via the
keys and the ISE display. Attention: This function should be carried out by a service technician
only.

Appendix

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Appendix

VITAL SCIENTIFIC N.V. A-1

A.1 Interface Description

A.1.1 RS-232 Description

The line signal definition is shown in the following table:

DB-25 Signal name direction remarks

* function depending on the COM-port settings

A-2 VITAL SCIENTIFIC N.V.

No use is made of a checksum.

VITAL SCIENTIFIC N.V. A-3

Direction analyzer → host

flags(22): see Extended result

A-4 VITAL SCIENTIFIC N.V.

Message Extended Result

Direction analyzer → host

FOR ISE TESTS:

For sample blank tests, the test_name(4) is upper/lowercase toggled

flags(22) see below

VITAL SCIENTIFIC N.V. A-5

detailed_info for MONO MODE:

used_i(1) 0: point_i not used

A-6 VITAL SCIENTIFIC N.V.

pos. flag error

pos. flag error

VITAL SCIENTIFIC N.V. A-7

Message Reagent installation

Direction analyzer → host

For sample blank tests, the test_name(4) is left blank.

A-8 VITAL SCIENTIFIC N.V.

Message Blank result

Direction analyzer → host

VITAL SCIENTIFIC N.V. A-9

Command Echo request

Direction host → analyzer

This message can be used as a test feature.

A-10 VITAL SCIENTIFIC N.V.

Command Get software version

Direction host → analyzer

VITAL SCIENTIFIC N.V. A-11

Command Get reagent installation

Direction host → analyzer

A-12 VITAL SCIENTIFIC N.V.

Command Get reagent test counters

Direction host → analyzer

For sample blank tests or uninstalled tests, the reagent_test_count(5) is set to 1.

VITAL SCIENTIFIC N.V. A-13

Command Request sample

Direction host → analyzer

Valid America values are:

request_test(1 .. 32) a row of at most 32 ‘0’ or ‘1’,

A-14 VITAL SCIENTIFIC N.V.

VITAL SCIENTIFIC N.V. A-15

Command Delete request sample

Direction host → analyzer

sample info (only present if status is 0):

A-16 VITAL SCIENTIFIC N.V.

Command Ask sample result

Direction host → analyzer

0: success: (sample ready or unloaded)

sample info (only present if status is 0 or 1):

IS REPEATED FOR EACH TEST.

If the result is not yet ready it is blank (‘’).