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Convergys ® ISE comfort

Electrolyte Analyzer
THE COMFORTABLE WAY OF ELECTROLYTE ANALYSIS

User's Manual
2015/23/04 Version 4.2

Convergys® ISE

Convergent Technologies GmbH & Co. KG


Ringstraße 14, D-35091 Cölbe, Germany
Tel.: +49 6421 8869948
Fax: +49 6421 8869958
www.convergent-technologies.de
info@convergent-technologies.de
Contents
1 CONTENTS
1 Introduction����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������5

2 General Safety Warnings and Instrument Working Conditions��������������������������������������������������������������������������������������������������������������������7


2.1 General Safety Warnings����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������7
2.2 Instrument Working Conditions�����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������7
2.3 Intended Use of the Instrument�����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������8
3 Description of the Instrument�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������9
3.1 Theory of measurement and calibration�����������������������������������������������������������������������������������������������������������������������������������������������������������������9
3.2 Front View�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 10
3.3 Rear View���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 10
3.4 Rinsing system ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 11
3.5 Inside Construction������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 11
3.6 Other Technical Features������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 12
4 Installation����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 13

5 Operation������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 14
5.1 Activation of the Instrument���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 14
5.2 Menu Construction������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 16
5.3 Menu Calibration����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 16
5.3.1 1-Point Calibration����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 17
5.3.2 2-Point Calibration����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 18
5.4 Menu Test��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 19
5.4.1 Blood Test������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 20
5.4.2 Urine Test������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 22
5.4.3 QC-1 Test�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 24
5.4.4 QC-2 test�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 25
5.5 Menu Set (setup)����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 25
5.5.1 Set date and time������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 26
5.5.2 Printer set up����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 26
5.5.3 Position adjustment�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 27
5.5.4 Parameter setup to set the relative coefficient���������������������������������������������������������������������������������������������������������������������������� 28
5.5.5 QC Set�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 30
5.5.6 Reset to Default set up�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 31
5.6 Menu Service������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 32
5.6.1 Rinse����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 32
5.6.2 Sensor�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 34
5.6.3 Data������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 35
5.6.4 Printer Test����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 39
5.6.5 System Status���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 40
5.6.6 Reagent���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 41
5.7 Instruction Note on Electrodes���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 42
5.7.1 Electrode Components ����������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 42
5.7.2 Preparing Electrodes for installation��������������������������������������������������������������������������������������������������������������������������������������������������� 42
5.7.3 Electrodes Maintenance���������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 42
5.7.4 Storage������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 42
6 Maintenance������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 43
6.1 Instrument maintenance����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 43
6.1.1 Daily maintenance ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 43
6.1.2 Weekly maintenance������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 43
6.1.3 Every three-month maintenance��������������������������������������������������������������������������������������������������������������������������������������������������������� 43
6.2 Electrodes abort and handle method�������������������������������������������������������������������������������������������������������������������������������������������������������������������� 43
6.2.1 1-point calibration failed���������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 44
6.2.2 2-point calibration failed���������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 44
6.3 Electrodes normal range������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 46
7 Pack list������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 47
7.1 Electrodes�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 47
7.2 Reagents����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 47
7.3 Accessories������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 47
1 INTRODUCTION

Convergys ® ISE comfort Electrolyte Analyzer is based on the advanced Ion Selective Electrode (ISE)
technology and has been designed as per the requirements and characteristics of international
market. Our main objective has been to make the hardware reliable and the software simple and
convenient to the user.
Convergys ® ISE comfort Electrolyte Analyzer uses English display system and has prompting for each
operation, which is very convenient to all users. Even the first-time users can learn the operations
of Convergys ® ISE comfort Electrolyte Analyzer quickly.
Convergys ® ISE comfort Electrolyte Analyzer can print testing report, store at most 250 tests and 31
tests for each of the 2 QC levels.

Warranty Information

Every Convergys ® ISE comfort Electrolyte Analyser unit is tested thoroughly before delivery to the
customers’ laboratory and is provided with a warranty for twelve months from the date of delivery/
installation (whatever is earlier) for all manufacturing defects. All claims on the Electrodes – for
whatever legal reason – shall be barred by the period of limitations after six (6) month and three
(3) months for Lithium electrode from the date of delivery.
The warranty is for all mechanical and electrical parts. It is granted only for a proper installation, use
and maintenance in compliance with the instructions as contained in this User’s Manual.
The warranty does not include any responsibility for any damages – direct or indirect to people
and/or material, caused by improper use and maintenance of the instrument.
All parts and consumables that are subject to deterioration because of their specific use, are ex-
cluded from the warranty.
Warranty does not include (if requested) the travel, lab-hours as well as accommodation expenses
if the instrument is damaged because of inappropriate handling.

Technical Services

Only Qualified Technicians/Service Engineers with suitable instrumentation and original spare parts
are authorized to fix the instrument. Ordinary and routine maintenance may be carried out by the
user as described in this User’s Manual.
When asking for service, refer to this manual indicating also the data reported on the identification
label of the instrument.

Ordering Spare Parts

Parts that are subject to deterioration or that are defective and need to be replaced have to be
requested from the company or its authorized agent/channel partner.

When ordering spare parts, the following details should be mentioned:


• Customer’s Purchase Order No.
• Name and version of the instrument
• Instrument Code Number
• Part Code Number
• Part Description
• Requested Quantity
• Name and address of company to deliver the ordered goods

Convergys ® ISE User's Manual 5


INTRODUCTION

Replacing the parts with ORIGINAL SPARE PARTS will be effective and ensure a long lasting instru-
ment life.
You are kindly asked to order the parts at your local distributors or directly from the Manufacturer.
Order address of the manufacturer is as follows:

Convergent Technologies GmbH & Co. KG


Ringstrasse 14, 35091 Coelbe, Germany
Tel. +49 6421 8869948
Fax. +49 6421 8869958
www.convergent-technologies.de
E-Mail : info@convergent-technologies.de

6 Convergys ® ISE User's Manual


2 GENERAL SAFETY WARNINGS AND INSTRUMENT WORKING CONDITIONS

2.1 GENERAL SAFETY WARNINGS

The following symbols stand for danger or warning:

General DANGER symbol. Indicates that not following relative instructions and warnings is a serious
safety risk.

Indicates ELECTRICAL VOLTAGE, which could cause death upon contact. Covers with this symbol
can be removed and replaced by qualified people and only after disconnecting electrical power.

Indicates that the instrument uses reagents and other DANGEROUS CHEMICAL SUBSTANCES which
can be corrosive, irritating or noxious and can cause health damages.

Indicates that the instrument handles potentially infectious samples, which could cause INFECTION/
CONTAMINATION. Always observe the general safety standard rules while handling these biological
substances. Wear protective goggles, gloves and clothing.

Indicates that not following the correct instructions can cause damage to the instrument and/or
its proper functioning.

Indicates important information concerning the instrument or a chapter of the document that is
important to read with particular attention.

2.2 INSTRUMENT WORKING CONDITIONS

Convergys ® ISE comfort Electrolyte Analyzer is intended to be used in the following working conditions:

• The instrument must be free from dust, mechanical vibrations, loud noises and electrical inter-
ference. Avoid placing the instrument in direct sunlight or in front of a source of heat or drafts.
• Use as In Vitro Diagnostic (IVD) medical device as specified in the technical data.
• Use of the chemical reagents and accessories supplied and/or declared to be compatible with
the instrument.
• Working at 15°C ~ 30°C and humidity level according to the information given in this User’s Manual.
• Do not install the instrument in a potentially explosive or fire hazardous environment.
• Power for this instrument should be AC 220 V ±22 V and 50 Hz ±1 Hz.
• The instrument should be properly grounded.

The instrument has to be used as described in this Manual. Any other use is regarded as inappropriate.

Convergys ® ISE User's Manual 7


GENERAL SAFETY WARNINGS AND INSTRUMENT WORKING CONDITIONS

2.3 INTENDED USE OF THE INSTRUMENT

Convergys ® ISE comfort Electrolyte Analyzer has to be used for the expected purpose and in perfect
technical working conditions, by qualified personal under the following maintenance operations:
• A Qualified User has to make sure that the environment conditions are suitable, the installation
is correct, the use and maintenance are proper according to the general safety rules as well as
to particular precautions as described in this manual (although he or she is not entitled to repair
the instrument).
• A Qualified Technicians/Service Engineer is entitled to service and fix the instrument with
original spare parts as per the instructions.

Modifications in the instrument are not allowed. The user is liable and responsible for any improper
modifications and for the consequences deriving from there.
For extraordinary maintenance, ask for licensed service centers. Specialized Technicians/Service Engi-
neers who will be able to fix the instrument using original spare parts will carry out the maintenance.

Always wear gloves to protect your hands when working with potential infectious agents
utilized in the laboratory for diagnosis.

8 Convergys ® ISE User's Manual


3 DESCRIPTION OF THE INSTRUMENT

3.1 THEORY OF MEASUREMENT AND CALIBRATION

The operation of Ion Selective Electrodes (ISE) is based on the fact that there is a linear relationship
between the electrical potential developed between an ISE and a Reference Electrode immersed
in the same solution, and the Logarithm of the activity (or “effective concentration”) of the ions in
the solution. This relationship is described by the Nernst equation:

E = E0 + (2.303RT ⁄ nF) × Log (a)


Where E = the total potential (in mV) developed between the sensing and reference electrodes.
E0 = is a constant which is characteristic of the particular ISE/reference pair.
(It is the sum of all the liquid junction potentials in the electroche mical cell)
2.303 = the conversion factor from natural to base10 logarithm.
R = the Gas Constant (8.314 joules/degree/mole).
T = the Absolute Temperature.
n = the charge on the ion (with sign + or -).
F = the Faraday Constant (96,500 coulombs per mole).
Log(a) = the logarithm of the activity of the measured ion.

Note that 2.303RT/nF is the Slope(S) of the line and this is an important diagnostic characteristic of
the electrode – generally the slope gets lower as the electrode gets old or contaminated and the
lower the slope the higher the errors on the sample measurements – e.g.: at S=55, a 1mV error in
reading will make about a 4% difference in concentration; at S=26 the difference will be more like 8%.
Because of the logarithmic relationship, the slope can most easily be determined as the difference
between the voltages measured in two solutions which differ by one order of magnitude – usually
expressed as mV/decade. The theoretical value for the slope at 25°C is 59.2 for monovalent ions
and 29.6 for divalent ions – but in practice these can vary considerably. The critical factor is not so
much the actual value of the slope but that this should be as high as possible and remain constant
over the range of concentrations and the time period required for the analysis.

The activity of an ion in solution is a measure of the number of ions taking part in any given reac-
tion, in this case those interacting with the ISE membrane. It is always less than the actual number
of ions present in the solution (i.e. concentration) because the mobility of the ions is reduced by
the presence of other ions in the solution. The higher the concentration of other ions, whether the
same or different from the species being measured, (i.e. the Ionic Strength of the solution) then the
stronger is this retarding effect and the greater the difference between activity and concentration.
However, it must be noted that in dilute solutions with low Ionic Strength this difference is small
and can be ignored in many practical applications – i.e. the calibration can be made and sample
results calculated using the more convenient concentration units.

The relationship between activity and concentration is defined by the Activity Coefficient as
f = a / c. This is dependent on the Ionic Strength of the solution, the valency and ionic radius of
the ion being measured. Note that the activity coefficient is always less than one, and the lower
the value the bigger the difference between activity and concentration.

The Ionic Strength (I) can be calculated from I = 0.5 × Sum (ci × Zi2)
Where c is the concentration in Moles and Z is the valency.

The Activity Coefficient (f) can then be found from:


−Log (f) = [(0.51 x Z2 × SQR (I)) ⁄ (1 + (3.29 × d × SQR (I))] − (0.1 × Z2 × I)
Where: Z = the ionic charge, I = the ionic strength of the solution, d = the ionic radius in nanometers.

Note that this formula is only accurate up to about I = 0.6 molar. At higher ionic strength other
factors come into play, which make the calculation of activity coefficients virtually impossible.

Convergys ® ISE User's Manual 9


DESCRIPTION OF THE INSTRUMENT

3.2 FRONT VIEW

1. LCD display: The screen is a 128 × 64 dots LCD display for user defined information and
test results.
2. User Interface via keyboard: The keyboard has been designed with only 3 keys in such a
way that all of them have a direct relationship with the instrument functions.
Yes: To enter, confirm
No: To select
Exit: To quit one function and return to previous menu.
3. Printer: The analyzer consists of a 58mm, fast and low noise inbuilt thermal printer is locat-
ed at the top of instrument.
4. Sample aspirate probe: Sample aspirate probe is under a blue handler; there is an optical
switch (OPT. SWT.) position sensor to detect the position of aspirate probe. When instru-
ment is working for test, lift up handler, the instrument will aspirate sample automatically
after 3 seconds. When sample aspiration is finished, close handler, the instrument will test
sample automatically.
5. Ion measuring chamber: The ion measuring chamber is composed of electrode housing,
box, cover; electrode rail, electrode connector and electrode fasten equipment. Measuring
chamber is the most important part of Convergys ® ISE comfort Electrolyte Analyzer. From
left to right, the position of electrodes is K+, Na+, Ca++, (Li+) , pH, Cl- and reference.
Please note that all the electrodes must be installed in the correct position in the chamber.
All electrodes are connected together and sealed by O ring, and together with test solu-
tion the electrodes become an ISE measuring system.
6. Electrodes and housing: Electrodes and housing are in the measuring chamber. The
cover of the measuring chamber is fixed to instrument box by a clip, and can be removed
by hand. There is a window below this cover, and you can watch the electrode housing
from this window. All ISE and reference electrodes are packed separately during shipment
and must be installed into the housing before switching ON the instrument. Please install
electrodes to housing as indicated in electrode housing.
7. Aspirate pump: The aspirate pump is located at the right side of measuring chamber.
8. Pinch valve: There are 2 pinch valves on the left side of sample aspirate probe.
9. Reagent housing: Reagent housing is at the bottom of instrument box, Cal-1 Cal-2 and
waste bottle must be installed in.

3.3 REAR VIEW

1. Power switch: To switch ON/OFF power supply.


2. Power socket: To connect instrument to power supply by power cord.
3. Fuse box: The Fuses are in the middle of power switch and power socket. The fuses are
installed inside the fuse box.
4. RS232 Port: To connect with the computer for data download.
5. Label: Describe the instrument S/N, ratings of power supply.
6. Grounded connector: The instrument is grounded using this connector.

10 Convergys ® ISE User's Manual


DESCRIPTION OF THE INSTRUMENT

3.4 RINSING SYSTEM

1. Rinsing cycle: During rinsing cycle, the pump aspirates air and Cal-1 alternatively; the air
and Cal-1 solution passes through a1--a2--Cal-1 pinch valve --a3--d1--ISE --d2--Pump--d3
and then goes to waste bottle.
2. Cal-1 cycle: During 1-point calibration, pump aspirates Cal-1 solution, passes through: a1-
-a2--Cal-2 pinch valve --a3-- d1-- ISE –d2 for calibration, when Cal-1 calibration is finished,
the solution passes through: d2--Pump--d3 and then goes to waste bottle.
3. Cal-2: During 2-point calibration, pump aspirates Cal-2 solution, passes through: b1--b2--
Cal-2 pinch valve --b3--d1--ISE—d2, for calibration, when Cal-2 calibration is finished, the
solution passes through: d2 –Pump—d3 and then goes to waste bottle.
4. Sample test: During sample test, pump aspirate sample, pass through: d1-- ISE –d2, when
test is finished, the solution passes through: d2 –Pump—d3 and then goes to waste bottle.

NOTE: KINDLY REFER TO THE DIAGRAM OF FLOW SYSTEM BELOW FOR DESCPRIPTION

Liquid
Detector Pump

ISE
K Na Ca pH Cl Ref

Cal-2
Valve

Cal-1
Valve

O-Ring

Ca1-1 Ca1-2 Waste


Picture 1: Schematic view of the liquid handling system.

3.5 INSIDE CONSTRUCTION

The inside of Convergys ® ISE comfort Electrolyte Analyzer houses Power Supply, CPU, Controller,
Drivers, and Measurement Circuits.
Power Supply: It provides +5V for logic circuit, Printer, LCD Display, +/-12V for the Simulation
Circuit, and Step Motor.
CPU: CPU system includes 8K EEPROM, 32K SRAM, I/O, real time clock etc.
Driver Circuit: Driver Circuit includes Drive Step Motor.
Measurement Circuits: Measurement Circuits consist of ISE sensor, Pre-amplifier and A/D converter.
A/D converter changes the ISE signal to digital signals for CPU system.

Convergys ® ISE User's Manual 11


DESCRIPTION OF THE INSTRUMENT

3.6 OTHER TECHNICAL FEATURES

Measured Parameters: K+, Na+, Ca++, Li+, pH, Cl-


Measuring principle: ISE based Electrolyte Analysis to Determine the Ion Concentration
of K+, Na+, Ca++, Li+, pH, Cl-
Throughput: 60 Samples/Hour including Printout
Reagent system: Calibrator-1 Solution, Calibrator-2 Solution, Cleaning Solution, ISE
and Ref. Electrode Filling Solution
Sampling method: Semi-Automatic Aspiration System, using Syringe, Sample Cup,
Capillary or Collection Tube.
Sample volume: 100µL
Sample type: Human (general): Whole Blood, Serum, Plasma, QC, And Diluted
Urine
Analysis time: Up to 60 seconds
Calibration: Fully Automatic, Manual One Point and Two Point Calibration
option.
Quality Control: Quality Control Storage: 2 Levels, 31 Days, Calculation of Mean, SD
and CV.
Cleaning procedure: Chemical Cleaning of the Measuring Chamber and Tubing System
with Cleaning Solution
Standby Mode: Pre-Adjusted with Automatic Calibration Step
Correlation Factors: User Programmable for Different Sample Types.
Normal Reference Range: Flagging off Abnormal Results, User Programmable Ranges.
User interface: Easy-to-use English Menu Driven User Interface with Soft Keys
Data capacity: 250 Results
Interface port: RS 232 Serial Link for Data Download
Built-in printer: Stationary Head Graphical Thermal Printer, 58mm Wide Paper Roll.
Prints Full Report
Display: 128 × 64 Dots High Contrast and Backlit LCD
Keypad: 3 Soft Keys for Simple Use
Electronics: Microprocessor Controlled
Power requirements: 100-120 or 200-240 VAC, 50-60Hz
Operating conditions: 15 to 30°C, 59-86° F (Optimal Temperature is 25° C,77° F), 20-80%
RH, ~ 1060hPa atmospheric pressure
Dimensions and weight: (W × D × H) 300 × 290 × 275 mm, ca. 6 Kg

12 Convergys ® ISE User's Manual


4 INSTALLATION

When installing and setting up the instrument, follow the general rules as described in this Chapter.

Convergys ® ISE comfort Electrolyte Analyzer has to be installed by qualified and trained Technicians/
Service Engineers. For correct operation please follow all the displayed instructions and please fill
up the installation card which is attached to this user manual.

Convergys ® ISE comfort Electrolyte Analyzer is packed in paper box during delivery. Proceed as
follows to install Convergys ® ISE comfort Electrolyte Analyzer:

1. Check if there are any damages on the packing, the instrument or the accessories and
verify completeness of the equipment and accessories with the Packing List.
2. Remove the package and take out the instrument carefully.
3. Check the Label at the back of the instrument and confirm the model of instrument with
the Packing List.
4. Make sure that the local power supply is same as that indicated on the Instrument label at
the back of the instrument.

Working beyond the tolerance limits of power supply will damage the instrument.

5. Place the instrument on a stable working platform (not less than 50 × 80 cm). The environ-
ment must be free from dust, mechanical vibrations, loud noises and electrical interfer-
ences. Avoid proximity to brush–type motors, flickering fluorescent lights and electrical
contacts that regularly open and close. Avoid placing the instrument in direct sunlight or
in front of a source of heat or drafts.
6. Open the front cover of the instrument. Connect the free end of the pump tube to the
waste bottle adapter and ensure that the tube is installed correctly into the peristaltic
pump.
7. Make sure that the electrodes are installed properly.
8. Customer must set the pipes according to the instruction picture in chapter 3.4 Rinsing
System.
9. Fix each of the given connecting tube in right way and position shown in chapter 3.4
Rinsing System
10. Place Cal-1and Cal-2 bottle in the right way and position.
11. The correct electrodes must be allocated to the appropriate channels. Open the cover of
electrode housing, install each electrode in the right position like marked on the electrode
housing itself, fasten the screw and close the cover.
12. Make sure that paper roll is placed properly in the inbuilt Printer.
13. Connect the power cord.
14. Connect the communication cable if necessary.
15. Fix grounded wire to properly ground the instrument
16. Make sure that all components are fixed correctly.

Convergys ® ISE User's Manual 13


5 OPERATION

User must follow the instruction in this Chapter to operate the instrument. Please read this manual
carefully.

5.1 ACTIVATION OF THE INSTRUMENT

Connect power cord to power supply and switch ON power. The instrument will go through the
following procedures after being switched ON.

The screen displays the model of instrument. The instrument


will check the control system, sample system, printer and sensor
during start up.

Convergys ® ISE
comfort Electrolyte
Analyzer

Convergys ® ISE comfort will rinse automatically to prepare for


Rinsing
Cal-1 calibration. If the instrument displays “NO liquid”, please
Please wait...
check the relative tubing’s and valves.

The instrument aspirates Cal-1 solution and begins 1-point cal-


1-Point Cal 1
ibration automatically. If the instrument displays “NO liquid”,
please check if Cal-1 bottle, relative tubing’s and valves are in
correct position.
Aspirating Cal-1
Please wait... Press “Esc” key to stop this step and instrument will return to
main menu.

14 Convergys ® ISE User's Manual


OPERATION

If the voltage of electrodes cannot be stable in 60 seconds or


1-Point Cal 1 0:50
out of range, the calibration fails and the 1-point calibration step
repeats 3 times. If calibration fails after 3 tries, the instrument will
display “1 point Cal failed” and then move to 2-point calibration.
K = 4.00 72.9
Na = 140.0 65.5 In case the 1-point calibration succeeds, then instrument displays
Cl = 100.0 86.4 “1-point Cal passed” and the procedure moves to the next step
Ca = 1.25 41.9 2-point calibration.
pH = 7.40 83.0

1-Point Cal passed

The instrument aspirates Cal-2 solution and begins 2-point cal-


2-Point Cal 1
ibration automatically. If the instrument displays “NO liquid”,
please check the relative tubing’s and valves.
Aspirating Cal-2
Please wait...

If the voltage of electrodes cannot be stable in 60 seconds or


2-Point Cal 1 0:52
are out of range, the calibration fails and 2-point calibration step
repeats 2 times. If calibration fails after 2 tries, the instrument
will display “2 point Cal failed” and then move to Main Menu.
K = 8.00 89.1
Na = 110.0 59.6
Cl = 70.0 91.1
Ca = 2.50 49.8
pH = 7.00 109.0

2-Point Cal passed

If Cal-2 calibration succeeds, instrument will display “2 point


Main Menu
Cal passed” and the procedure returns to Main Menu to wait
for further selections.

Cal Test
Set Serv
The instrument runs self-cleaning every 20 min. in Standby Mode.
2011/11/10 10:00

Convergys ® ISE User's Manual 15


OPERATION

5.2 MENU CONSTRUCTION

The display of Convergys ® ISE comfort Electrolyte Analyzer is simple, in English. The User can operate
it by pressing the three keys, which are Yes, No and Esc. Yes key is for confirmation, No key is to
select functions, and Esc key is for return to previous menu.
Main menu provides all functions of this instrument, which are Cal (calibration), Test (performing
a probe measurement), Set (setup) and Service. The construction is as following:

Main Menu

Cal Test
Set Serv
2011/11/10 10:00

Calibration Test Set Service

1-Point Cal Blood QC1 Time Para. Clean Sensor


2-Point Cal Urine QC2 Print QC Data Print
Posi. Reset Status Reagent

5.3 MENU CALIBRATION

The Convergys ® ISE comfort contains two different calibration modes. The first is 1-Point calibration
and is performed only with the Cal-1 solution. To adjust the instrument within the measurement
range, it is necessary to choose a 2 point calibration. Therefore 2-Point calibration uses Cal-1 and
Cal-2 to adjust the instrument within the measurement range.

Use the calibration function to check the stability of electrodes,


Main Menu
voltage base point and coefficient.
The “Esc” Button is used to go back to the previous menu.

Cal Test
Set Serv
2011/11/10 10:00

16 Convergys ® ISE User's Manual


OPERATION

Choose 2-Point Cal to calibrate the instrument within the range


Calibration
of two concentrations of electrolytes. Choose 1-Point Cal to
readjust a calibrated range.

1-Point Cal
2-Point Cal

During 1-Point and 2-Point Cal procedure, if a flag “*” appears before an electrode name, it means
the electrode is unbalance in 60 seconds, “~” means the electrode instable,’﹟” means voltage of
electrode is beyond default range (lower than 10 or higher than 180), “^” means the electrode’s
mV of Cal-1 and Cal-2 are beyond default range.

~ = The electrode is instable


* = Electrode is unbalanced in 60 seconds
# = Voltage of the electrode is beyond
defined range
^ = The electrodes voltages of Cal-1, Cal-2
are beyond default range

5.3.1 1-POINT CALIBRATION

The instrument aspirates Cal-1 solution for rinsing. If the instru-


1-Point Cal 1
ment displays “NO liquid”, please check if Cal-1 bottle, relative
tubing’s and valves are in correct position.
Rinsing
Please wait...

The instrument aspirates Cal-1 solution and begins 1-point cal-


1-Point Cal 1
ibration automatically. If the instrument displays “NO liquid”,
please check the relative tubing’s and valves.
Aspirating Cal-1
Please wait...

Convergys ® ISE User's Manual 17


OPERATION

If the voltage of electrodes cannot be stable in 60 seconds or


1-Point Cal 1 0:52
out of range, the calibration fails and the 1-point calibration step
repeats 3 times. If calibration fails after 3 tries, the instrument will
display “1 point Cal failed” and then move to 2-point calibration.
K = 4.00 72.9
Na = 140.0 65.5
Cl = 100.0 86.4
Ca = 1.25 41.9
pH = 7.40 83.0

When the Cal-1 calibration succeeds, the instrument will display


1-Point Cal 1 0:52
“1-point call passed”.

K = 4.00 72.9
Na = 140.0 65.5
Cl = 100.0 86.4
Ca = 1.25 41.9
pH = 7.40 83.0

1-Point Cal passed

5.3.2 2-POINT CALIBRATION

Choose 2-Point Cal to calibrate the instrument within the range


2-Point Cal 1
of two concentrations of electrolytes.
Instrument will perform both 1-point calibration and 2-point
Aspirating Cal-2 calibration, if the user selects “2-Point Calibration” option under
Please wait... Calibration menu.
When the 1-point calibration succeeds, the instrument will dis-
play “1-point call passed” and procedure will move to 2-point
calibration automatically.

The instrument aspirates Cal-2 solution and begins 2-point cal-


2-Point Cal 1 0:52
ibration automatically. If the instrument displays “NO liquid”,
please check the relative tubing’s and valves.
K = 8.00 89.1
Na = 110.0 59.6
Cl = 70.0 91.1
Ca = 2.50 49.8
pH = 7.00 109.0

18 Convergys ® ISE User's Manual


OPERATION

If the voltage of electrodes cannot be stable in 60 seconds or


2-Point Cal 1 0:52
are out of range, the calibration fails and 2-point calibration step
repeats 2 times. If calibration failed after 2 tries, the instrument
will display “2-point Cal failed” and then move to Main Menu.
K = 8.00 89.1
Na = 110.0 59.6 If 2-point calibration succeeds, instrument will display “2 -point
Cl = 70.0 91.1 Cal passed” and the procedure returns to Main Menu automat-
Ca = 2.50 49.8 ically
pH = 7.00 109.0 During 1-Point and 2-Point Cal procedure, mmol/L values and
mV values are shown simultaneously on the right side against
2-Point Cal passed the particular electrode.

When 1-Point and 2-Point Cal fails, and the user cannot be sure what is wrong with the electrodes.
Please fully carry on 2-Point Calibration once and record the data. Report those data to agent,
manufacturer and engineer to get better technical support.

5.4 MENU TEST

The Convergys ® ISE comfort’s Test menu is for testing samples, which includes blood samples, urine
samples and QC.
Before running any test, 1-point calibration and 2-point calibration must be passed, otherwise
sample results cannot be correct.

While entering test menu from standby mode the instrument


Main Menu
will automatically do 1-point calibration in order to adjust the
instrument so to insure the accuracy.

Cal Test
Set Serv
2011/11/10 10:00

Switch selection in Test menu by pressing the No button.


Test
Choose the “Blood” for analysis of blood and serum samples;
choose the “Urine” for analysis of diluted urine samples;
Choose the “QC1” for analysis of QC level 1 and choose the “QC2”
Blood QC1 for analysis of QC level 2.
Urine QC2

Convergys ® ISE User's Manual 19


OPERATION

5.4.1 BLOOD TEST

Blood sample types: Serum, Blood Plasma and Whole Blood.


The blood sample should be tested as soon as possible, and the anticoagulant should not contain
any material which affects the ion measurement that will be tested or it shouldn’t interfere with the
test. Samples should be stored in refrigerator after airproof. Storage time should not be more than
24 hours. The user should bring the sample to indoor temperature for the test.

Choose “Blood” to perform a test with Whole Blood, Serum or


Test
Plasma.
Approximately 100 µl of blood are required to perform a single
test.
Blood QC1
Urine QC2

Press “No” key to edit ID, press “Yes” key to confirm.


Blood Test

ID=001 ?

Edit the sample ID by using the “No” key, press “Yes” key to con-
Blood Test
firm.

ID=001

20 Convergys ® ISE User's Manual


OPERATION

When the sample is ready, please lift Sample Probe Handle and
Blood Test 001
insert Sample Probe into the sample cup or sample tube. The
instrument can aspirate sample and self check the aspirating
status automatically.
For measurement
Open inlet flap

Blood Test 001

Aspirating
Please wait...

After aspirating default quantity sample, the program will alarm


Blood Test 001
user to take out the sample tube from the Sample Probe. Please
clean the outlet of probe with clean paper and close Sample
Probe Handle.
Sampling completed
Close inlet flap

The instrument aspirates the sample into the measuring channel


Blood Test 001 0:54
and begins measuring. When “=” appears before a certain item,
it express that this ion has been tested. When all of the ions are
tested, instrument automatically performs washing cycle.
K = 4.05
Na = 140.8 It uses “?” to express test results caused by calibration failure
Cl = 99.5
Ca = 1.02
pH = 7.46

Convergys ® ISE User's Manual 21


OPERATION

“L” and “H” in report indicate the result is Lower (L) or Higher (H)
Blood Test 001 0:54
than the default normal range. After the test, the instrument will
calculate the n-Ca and T-Ca when pH=7.4 The instrument does
not calculate them when pH calibration failed.
K = 4.05
Na = 140.8
Cl = 99.5
Ca = 1.02
pH = 7.46

The instrument can aspirate sample and self checks the aspirating status automatically. If the screen
shows “Sensor Error”, please check if there is air in the tubing or tubing is broken. If it is true, the
instrument will begin rinsing program and return to previous menu.

Common interference matters: Salicylate, Sodium azide, Sodium benzoate have serious interference
to the Cl electrode. Heparin, Citrate may combine with Ca++ ion, which cause lower Ca result.

5.4.2 URINE TEST

If the instrument is in Standby, then on exiting the standby mode,


Test it will perform 1-point calibration automatically in order to adjust
the instrument so to ensure the accuracy.
To measure urine, use a 1:9 Convergys ® Cal-1 dilution of the urine
Blood QC1 sample.
Urine QC2 To prepare a dilution, mix one part of urine with 9 parts of Cal-1
solution. The test method is the same as blood sample; urine
sample test calculates K, Na, and Cl.

Test method is the same as of blood sample.


Urine Test

ID=002 ?

22 Convergys ® ISE User's Manual


OPERATION

Attention! When you want to measure different kind of sam-


Urine Test 002
ples in a row such as from measuring urine to blood, you can't
measure directly, in order to prevent getting false calculation
results, you should return test menu first and then get into test
procedure according to the test sample kind.
For measurement
Open inlet flap

Urine Test 002

Aspirating
Please wait...

Urine Test 002

Sampling completed
Close inlet flap

When flag “>” or “<” appears before a definite item, that means
Urine Test 002 0:50
abnormal inhaling or there is an air bubble in the sample. Except
the above reasons, if the sample is urine, this might caused by
an inaccurate dilution.
K = 4.55
Na = 143.8
Cl = 100.5

Convergys ® ISE User's Manual 23


OPERATION

5.4.3 QC-1 TEST

QC Test: The instrument provides an auto Statistic Analysis and


Test computes related K and D data.

Blood QC1
Urine QC2

The QC sample should not have any material to produce the


QC-1 Test 001
interferences to electrodes. Such as Salicylate, Sodium azide,
Sodium benzoate has serious interference to the Cl electrode.

For measurement
Open inlet flap

In QC-1 and QC-2 option, the test method is the same as for
QC-1 Test 001
testing blood sample, QC test does not display calculated
item (T-Ca and n-Ca).

Aspirating
Please wait...

QC-1 Test 001

Sampling completed
Close inlet flap

24 Convergys ® ISE User's Manual


OPERATION

During the measurement, the Convergys ® ISE comfort counts


QC-1 Test 001 0:53
down until the measurement is done.

K = 4.05
Na = 140.8
Cl = 99.5
Ca = 1.02
pH = 7.46

If the QC Data are out of range (see picture), the instrument will
QC-1 Test 001 0:53
alarm QC data out of range and the user can decide to store
them by selecting “Yes” or “No”.
K = 6.05
Na = 140.8
Cl = 99.5
Ca = 1.02
pH = 7.46

QC out of range, Save?

5.4.4 QC-2 TEST


For QC-2 please refer the instructions above for QC-1 Test.

5.5 MENU SET (SETUP)

The setup menu is used to set or modify the parameters for Convergys ® ISE comfort Electrolyte
Analyzer, which includes date, normal reference range, relative coefficient and print model. Among
those parameters, only relative coefficient will effect on the test result while others will not.
When relevant coefficients are changed, the analysis results will be different.
If user needs to modify relative coefficient, please record the present factors before modifying,
to recover the instrument if modification failed.
All of the parameters are pre-installed from factory. When some parameters are carelessly changed,
please check this instruction and set default values or directly use the “Reset” function to recover
all instruments parameter into factory setup.

Main Menu

Cal Test
Set Serv
2011/11/10 10:00

Convergys ® ISE User's Manual 25


OPERATION

5.5.1 SET DATE AND TIME

There is a real time clock to save date and time setting, so the
Set instrument can keep date and time setting even when it is pow-
ered off for a long time. User can use the date and time setup
function to modify the setting if it is necessary.

Time Para.
Print QC
Posi. Reset

Use No key to modify and Yes key to save the date and time
Date&Time
setting.

Date 2011/11/10
Time 10:35

5.5.2 PRINTER SET UP

Default print setup is ON


Set

Time Para.
Print QC
Posi. Reset

The user can activate the printer by toggle the printer mark to
Printer
“Printer on”.

 Printer On
 Printer Off

26 Convergys ® ISE User's Manual


OPERATION

By selecting or deselecting the items with the “Yes” or “No” key,


Printer
user can decide whether to print pH, n-Ca, Ca, T-Ca result ac-
cording to the requirement (only for 5 electrodes instrument).
User can select according to his/her requirements.
Item pH Ca n-Ca T-Ca
State    

5.5.3 POSITION ADJUSTMENT

The Position menu can be used to modify the liquid flow of the
Set
tubing system. The default setup is auto. Choose the manual
adjustment function to use the stepping function of the inte-
grated pump with given manual parameters.
Time Para.
Print QC
Posi. Reset

In the case of manual adjustment, the parameters are adjusted


Liquid Position Mode
to fixed values and the automatic function of the liquid detector
is not in use. The manual stepping for the pump can be adjusted
by user.
  Auto
 Manual

This operation is set by step number of the stepper motor rota-


Liquid Position Mode
tion. The instruments are adjusted well during the manufacturing
and user shall use this function only if the solutions do not reach
the specific levels.
Liquid Position
Cal-1 0850
Cal-2 0950
Sample 0500

Convergys ® ISE User's Manual 27


OPERATION

5.5.4 PARAMETER SETUP TO SET THE RELATIVE COEFFICIENT

Choose Parameter by using the No key and press Yes key to


Set enter the Parameter menu.

Time Para.
Print QC
Posi. Reset

Press “Yes” key to confirm. Press “No” key to activate or deactivate


Parameter
K, Na, Cl, Ca, pH and Li channel.

Deactivated channels will be marked by “x”.


Item K Na Cl Ca pH Li
State      

Press “No” key to open or close select channel, press the “Yes”
Parameter
key to modify the selected channel.

Item K

Generally user needs to change relevant coefficient, unless many


Parameter
experiments are done and it is discovered that a certain result is
actually higher or lower. In this case, user may adjust relevant co-
efficient and correct “intercept (d)”. It is not necessary to change
relevant coefficient correction “slope (k)”.
Item K
Correction factors
y=kC+d
K=1.00 d=-0.15

28 Convergys ® ISE User's Manual


OPERATION

Parameter

Item K
Ref-range mmol/L
L=3.50 H=5.50

Use the No key to toggle the values between the k, d, L, Δ L and


Parameter
Δ H parameters. Use the Yes key to confirm.

Item K
Δ=Cal2-Cal1 (mV)
L=10.0 H=20.0

In the trace menu usage of the trace function can be activated


Parameter
or turned off. The trace function is an automatic trace function
that can monitor the drift of electrodes during continuous tests
ISE Auto Trace to get more accuracy.

  On
 Off

The manufacture has used high value QC serum to adjust the relative coefficient of every instrument
before delivery in order to ensure the accuracy of test. Do not change the relative coefficient unless
it is necessary. When the result is higher or lower than the normal range, user can modify the “d”
data, and do not need to modify the “k” data.

Default : K = 1.00C-0.15 (0.0~0.35) Na = 1.00C-05.0 (02.0~08.0)


Cl = 1.00C-08.0 (02.0~10.0) Ca = 0.89C-0.06 (0.03~0.09)
pH = 1.00C-0.15 (0.10~0.30) Li = 1.00C-0.15

The above parameters can affect the test result, please use QC serum to adjust those parameters.
The manufacture set the above parameters after carrying out large number of experiments and
provides them to user as reference. It is necessary for the user to adjust those parameters according
to their special conditions.
The instrument use “L” and “H” to show the calibration status of every electrode. Please see 6.3 of this
manual to see the normal calibration range. “L” and “H” are used to show the test result be higher
or lower than the normal range.

Convergys ® ISE User's Manual 29


OPERATION

5.5.5 QC SET

According to the QC instruction contents, user can set QC Lot


Set number, target values and reference range for each parameter.

Time Para.
Print QC
Posi. Reset

Choose QC-1 or QC–2 to modify the parameters.


QC Set

Pressing Yes will modify the QC-1 LOT. Pressing No will lead
direct to the menu of QC-1 parameters.
QC1 set
QC2 set

If there are already some existing statistics, the instrument will


QC-1 Set
alarm whether to “Clear QC statistic?” Operators needs to choose
according to their requirements.

No:000001

Set up QC target. Press No key to modify the values, press Yes


QC-1 Set No:000001
key to confirm, press Exit key to move to next line.

Item K

30 Convergys ® ISE User's Manual


OPERATION

Set up values of QC target, lower limit and higher limit, using No


QC-1 Set No:000001
key to modify the values and Yes key to confirm.

Item K
Target =4.67
Limit L=4.39
Limit H=4.75

5.5.6 RESET TO DEFAULT SET UP

The parameters might be confusing after being edited. Use the


Set “Reset” function to recover the default settings. Recovering to
default data would clear the QC history data.

Time Para.
Print QC
Posi. Reset

Confirm the reset of the instrument to standard settings by “Yes”,


Reset
or leave the menu by pressing “No”.

Reload default set,


Sure?

Set

Resume setup
Please wait...

Convergys ® ISE User's Manual 31


OPERATION

Factory default values:

Subject Relevant coefficient Normal value Δ value range


K 1.00C-0.15 3.50-5.50 10-20
Na 1.00C-5.0 135-145 -3- -9
Cl 1.00C-8.0 96-110 3-8
Ca 0.89C-0.06 1.25-1.25 4-12
pH 1.00C-0.15 7.4-7.4 10-30
Li 1.00C+0.00 0.00-1.20 -3- -20
n-Ca - 1.05-1.30 -
T-Ca - 2.1-2.6 -

5.6 MENU SERVICE

5.6.1 RINSE

The Service Menu provides the user to check, maintain and refer
Main Menu the instrument information.

Cal Test
Set Serv
2011/11/10 10:00

Service

Clean Sensor
Data Print
Status Reagent

32 Convergys ® ISE User's Manual


OPERATION

The Clean option provides customer with automatic cleaning


Service
function, which can keep instrument daily maintained. Customer
can use this function to perform daily cleaning.

Clean Sensor
Data Print
Status Reagent

After pressing the clean function, instrument is waiting for the


Clean
user to open the Probe Handler and to start the aspiration of
the cleaning solution.

For clean
Open inlet flap

After suitable amounts of the cleaning solution have been


Clean
aspirated by the machine, the instrument displays Sampling
completed, closing inlet flap. After closing the Probe Handler,
instrument starts cleaning.
Aspirating solution
Please wait...

The instrument aspirates cleaning solution to rinse tubing’s and


Clean
electrodes. This procedure needs about 10 min. Press “Exit” key
to stop it.

Sampling completed
Close inlet flap

Convergys ® ISE User's Manual 33


OPERATION

The remaining time of the Cleaning is shown on the right panel


Clean 9:55
in MM:SS format.

Cleaning...

5.6.2 SENSOR

Sensor is use to check the status of electrodes and their amplifier. Please refer to the normal mV
range data in this manual to make judgment and use the corresponding method to handle it. This
function can also be used to re-active the electrodes.

Let the instrument aspirate fresh Serum or QC solution into elec-


Service trodes. Customer can stop it by pressing “Exit” button.

Clean Sensor
Data Print
Status Reagent

Sensor

Aspirating solution
Please wait...

34 Convergys ® ISE User's Manual


OPERATION

When the electrodes cannot be stable or the mV (voltage) is


Sensor
beyond range, user can use QC blood sample, fresh serum or
fresh blood sample to activate the electrodes. This process will
need about 90 minutes to complete and can be repeated till
K 62.9 mV
the electrodes are stable.
Na 75.3 mV
Cl 72.2 mV
Ca 69.1 mV
pH 76.6 mV

If the mV (voltage) moves high or low, this indicates that the ground line is not connected properly,
and is causing interference to the instrument. Please properly connect the ground line.

5.6.3 DATA

Customer can use data management function to view and delete


Service test data, manage the communication between instrument and
computers for transfer data and to view the last calibration data.

Rinse Sensor
Data Print
Status Reagent

Data

Recall Stat.
Comm. Cal-D

Convergys ® ISE User's Manual 35


OPERATION

Data recall

Recall the information of blood sample or QC sample.

Choose the type of sample you want to recall. You can choose
Data blood or urine with the same button.

Recall Stat.
Comm. Cal-D

Last measurements are selected first automatically. For recall


Data Recall
of other ID’s press “No” to enter the ID number, press “Yes” to
confirm.

Samp. data
QC-1 data
QC-1 data

If the input ID does not exist in the database, the instrument will
Data Recall
display “Not found!” When no sample or QC test being done, and
there are no sample or QC data, the instrument will display “No
sample data!” or “No QC data!”
ID=001

36 Convergys ® ISE User's Manual


OPERATION

Statistics

The instrument will automatically calculate the values for average


Data (AVG), standard deviation (SD) and the coefficient of variation
(CV).

Recall Stat.
Comm. Cal-D

Press Yes key to print


QC Statistic

QC-1 Stat.
QC-2 Stat.
QC Adjust

To adjust the Convergys ® ISE comfort, instrument requires more


QC-1 Stat. result
than 5 measurements of QC-1 and QC-2 Data sets.

AVG SD CV(%)
K 4.05 0.85 0.54
Na 140.8 1.26 0.85
Cl 99.5 2.17 0.67
Ca 1.02 0.42 1.54
pH 7.46 0.11 0.22

After set up the QC target ad finish the statistic, the instrument


QC Statistic
will auto remind whether calculate K and D value of each ion
(auto adjust relative parameter). The instrument will not carry
on the function when the difference of ion concentration is
below 25%. Do not carry on adjusting more than one time by
QC-1 Stat.
one set of QC data. User should clear QC data and carry on QC-1
QC-2 Stat.
and QC-2 again in order to get right adjusting parameter. The
QC Adjust
concentration difference of each ion should be 25%. It is better
if the concentration is within double.

Convergys ® ISE User's Manual 37


OPERATION

QC Adjust

QC-1 ( 6)
QC-2 ( 6)
Adjust?

QC Adjust

QC-1 ( 6)
QC-2 ( 6)
Adjusting...

Communication

The user can use this function to transfer data to a computer.

The computer and the instrument must be connected with a


Data serial port line; the instrument internal data is transmitted to the
computer at a baud rate 9600, use ASCII code. Computer receives
data by serial port receiving program. The sending data accord-
ing to a sequence of date, time, ID, item, result and test mark.
Recall Stat.
Comm. Cal-D

Since all are transmitted by ASCII code, they can be straightly


Data transmit
displayed in receiving program. If some item does not be tested,
it will display “----” instead of the result. If the value of T-Ca is -100,
then the sample is urine sample.
Samp. data
QC-1 data
QC-1 data

38 Convergys ® ISE User's Manual


OPERATION

Calibration data

To review current calibration data that used for the measurement


Data choose Cal-D.

Recall Stat.
Comm. Cal-D

The calibration data can be printed by pressing “Yes”. Use “Exit”


Calibration Data
to exit and go back to previous menu.

Cal-1 Δ S
K 71.9 16.5 55.4
Na 84.3 -6.3 53.6
Cl 89.2 6.5 56.9
Ca 69.1 8.6 28.0
pH 76.6 24.4 61.2

Referring to Chapters 5.3 and 6.3 in which the electrodes normal output reference values are
described, User can judge electrode fault and treat them accordingly. When 1-Point or 2-Point Cal
fails, and the user cannot make sure the cause of the electrodes fault, please do a 2-point Cal and
record the group of statistics, and forward the report to your dealer or service engineer in order to
get further support.
Remarks: Cal-1 in the chart is Cal-1’s mV.
Δ is slope Cal-2 and Cal-1’s mV difference.
S is electrode slope.

5.6.4 PRINTER TEST

If the printer is connected and ON, you can test the printer with
Service this function. Press Yes for printer test.
Instrument will display “printer test OK” and the printer will print
“electrolyte analyzer thermal printer self check OK”.
Rinse Sensor
Data Print
Status Reagent

Convergys ® ISE User's Manual 39


OPERATION

If the printer is OFF or not connected, instrument will display


Printer “Printer test err”.

Print test OK

5.6.5 SYSTEM STATUS

For documentation, control and service, the system offers a


Service printout function of the system status report with detailed in-
strument related information:
S/N, software version, calibration data, statistics, level sensor
Rinse Sensor statistics, relevant coefficients and normal reference values.
Data Print
Status Reagent

Press Yes to the print out the status report.


System status

Print status-report?

40 Convergys ® ISE User's Manual


OPERATION

5.6.6 REAGENT

The newly integrated Reagent lock-in module ensures that only Convergent validated reagents are
used for uniform results. This system has been introduced for Cal-1 and consequently every new
Cal-1 pack shall come with a new IC card. An IC card is for a single use only. The attempt to replace
Cal-1 with a previously used IC-card or any other invalid card (e.g., from any other manufacturer)
shall yield error messages. Please read the following chapter carefully to avoid any operational errors.

The instrument requires IC cards to control


Service
Cal-1, the user has to select the Reagent option to replace the
Cal-1 when the screen shows “replace reagent” or when the
bottle of Cal-1 is empty.
Rinse Sensor
Data Print
Status Reagent

First, place a new Cal-1 to replace the old one.


Replace Reagent
Secondly, put a new valid IC card on the card reader position.
Press Yes key, the instrument will show “Read card success !”. The
instrument will automatically begin to use the new reagent.
Replace Cal-1
Read card ?

NOTE:
Replace Reagent
Do not move the IC card away from the card reader during the
replacement.
The instrument will show “Invalid Card !” when you try to use
Read card success ! a previously used card or any other invalid card. If the replacing
procedure is handled without using the IC card, the instrument
will show “Read Card Error !”.
PLEASE REMEMBER THAT EVERY IC CARD IS FOR A SINGLE USE
ONLY.

Replace Reagent

Replacing
Please wait***

Convergys ® ISE User's Manual 41


OPERATION

5.7 INSTRUCTION NOTE ON ELECTRODES

5.7.1 ELECTRODE COMPONENTS

The Convergys ® ISE electrodes have the following components as depicted in the following graphic:

CAUTION:
DO NOT USE ANY SHARP TOOLS LIKE NEEDLE FOR
FILLING THE ELECTRODES. IT WILL DAMAGE THE
ELECTRODES MEMBRANE!

5.7.2 PREPARING ELECTRODES FOR INSTALLATION

The electrodes should be filled up with the Filling Solution before they are installed. The Filling
Solution is added in the electrodes from the filling solution vials. The electrodes should be filled up
with 2/3rd of the inner chamber. Fasten the electrodes and shake well to remove any air bubbles
present in the liquid chamber before installing the electrodes in their designated positions.
Note: If you use a syringe, transfer the contents of the tube into the syringe (NO NEEDLE) and fill
the electrodes body slowly until appropriate liquid level of 2/3rd with NO BUBBLES.

5.7.3 ELECTRODES MAINTENANCE

Use fresh serum to activate the electrodes till they are stable. It might need approximately 90
minutes and the process has to be executed in the “sensor” mode.
The equipment may report inconsistent results in case the electrodes are contaminated. Please use
anti-protein solution to clean regular contamination. In case of heavier contamination the operator
may consider using a thin cotton thread and moving it carefully through the sample channel.
The electrodes may face attrition in case filling solution is not adequate in the inner chamber of
electrodes. Please remove the left out filling solution from the electrodes and fill up with the fresh
Filling Solution.

5.7.4 STORAGE

Electrodes should be kept away from direct sunlight and should be placed at room temperature.
Do not freeze the electrodes. Always keep the packing information, serial numbers of the electrodes
and the installation date of the electrodes for obtaining regular service from your vendor.

42 Convergys ® ISE User's Manual


6 MAINTENANCE

6.1 INSTRUMENT MAINTENANCE

Instrument maintenance is very important, it will help customer to operate the instrument and
ensure the test quality. Please follow the instruction:

6.1.1 DAILY MAINTENANCE

Check the level of Cal -1 solution; please change the solution bottle when level is lower than 1cm.
Check the level of Cal-2 solution; please change the solution bottle when level is lower than 1cm.
Check the level of waste bottle; please empty it when the waste is more than half of the bottle.
Protein removal maintenance: This can help the electrodes work longer. When the daily test job is
done, please rinse tubing with anti-protein solution and Cal-1 solution several times. To keep the
Convergys ® ISE comfort in good working condition perform the cleaning procedure every day after
testing blood or serum samples.
Clean the sample aspirate probe and fasten connection with water. Alcohol and other solvents are
strongly forbidden.

6.1.2 WEEKLY MAINTENANCE

Clean the instrument thoroughly.


Check the electrode system: Slightly move the connect screw and make sure the electrodes are
properly tight and well aligned.
Protein removal maintenance: If the daily test is rough less, please do Protein removal maintenance
using cleaning solution at least once a week.

6.1.3 EVERY THREE-MONTH MAINTENANCE

Please change pump tubes if necessary.


Please change connecting tubes if necessary.
Check the filling solution of every electrode; change it if necessary.
Check the filling solution of reference electrode, change it if necessary.
Change O ring. Anything wrong with the O ring will lead air into the measuring system or system
can fail to aspirate solution.

6.2 ELECTRODES ABORT AND HANDLE METHOD

This instrument provide on-line self-checking function, the screen will display the error when
something wrong happens with the electricity system. Please contact the manufacturer or the
distributor when this happen. Customer can solve some failure with electrode by himself following
the below instruction:

Convergys ® ISE User's Manual 43


MAINTENANCE

6.2.1 1-POINT CALIBRATION FAILED

Caused by electrode unstable:


• Check if the electrode is new. If yes, it will take 90 minutes to be stable, it is strongly recommended
to use fresh serum to activate the electrodes.
• Check for the below points if one or more electrodes are unstable, Check if
a. There is an air bubble on the membrane of the electrode. In this case please tap the
electrode with fingers until the air bubble goes out.
b. There is something wrong with the O ring. In this case take out the electrode, clean the
O ring and put it back again, or change O ring.
c. The Electrode connection tube is dirty. In this case rinse with anti-protein solution.
d. The Electrode quality is fade. In this case change the electrode.

Caused by Cal out of range:


• Cal out of range in all the electrodes, Check if
a. There is an air bubble in the reference electrode. In this case tap reference electrode with
fingers several times until the air bubble goes out.
b. The level of reference filling solution is low. In this case refill the filling solution.
c. The orifice on the top of the reference electrode is clogged. In this case open it with needle.
d. The pipeline of reference electrode is dirty. In this case rinse it with anti-protein cleaning
solution
e. The AgCl on the reference electrode internal element drops. In this case change the
reference internal element.
f. The membrane of reference electrode is broken. In this case change the reference elec-
trode.

• One electrode voltage is out of range. Check if


a. The level of electrode filling solution is low. In this case change the filling solution.
b. The pipeline of electrode is dirty. In this case rinse with anti-protein cleaning solution
c. The AgCl on the electrode internal element drops. In this case change the internal element.
d. The Electrode quality fades. In this case change the electrode.

• Caused by Sample fault or there is air bubble in the electrode:


Check if the pipe is clogged or broken. Check the O-ring in the sample system.
Check the pipe step by step to see if it is clogged or if it is broken referring to the pipe design
picture.
Check if there is enough solution in the calibration bottle.
Check if the solution is polluted.

6.2.2 2-POINT CALIBRATION FAILED

Caused by electrode unstable


• Check if the electrode is new. If yes, it will take 90 minutes to be stable. If all electrode or only Na
electrode is unstable, it is most might be caused by reference electrode. Check if
a. There is an air in the conjunction of electrode. In this case shake the electrode several
times until the air bubble goes out.

44 Convergys ® ISE User's Manual


MAINTENANCE

b. The orifice on the top of the reference electrode is clogged. In this case open it with needle.
c. The AgCl on the reference electrode internal element drops. In this case change reference
internal element.
d. The membrane of reference electrode is broken. In this case change reference electrode.

• Check if one or more electrodes are unstable


There is air bubble on the membrane of the electrode. Click the electrode until the air bubble
goes out.
There is something wrong with the O ring. In this case away and put back the electrode again
or change O ring.
The electrode pipeline is dirty. In this case rinse with anti-protein solution.
The electrode quality fades. In this case change the electrode.

Caused by slope out of range


If all electrodes show slope are out of range, please check if your calibration solution 1 and 2 are in
the right place or if they are polluted.

Only one electrode shows the slop out of range


a. The electrode membrane is dirty. In this case rinse with anti-protein solution several times.
b. The electrode quality fades. In this case change the electrode.

Possible cause for aspiration failure of solution


• Check if the pipe be clogged or broken, if the inlet probe is clogged or if the O-ring is broken.
• Check the pipe to see if it is clogged or if it is broken step-by-step referring to the schematic
view of the liquid handling system.
• Check if there is enough solution in the calibration bottle.
• Check if the electrode is polluted

Abnormal measured results


• Caused by aspirating solution failure

The instrument has a self-checking aspirating status function. When it fails to aspirate solution the
screen will display “sensor error”, and the instrument will start cleaning program and then exit test
program. Please solve the problem with the following instruction:
a. Check the pipe to see if it is clogged or if it is broken step by step
b. Check the inlet probe to see if it is clogged.
c. Check the inlet probe O-ring to see if it is broken.

• Caused by mistake operation


Please go to the “menu\ set up\ parameter” manual, and check if all the parameters are right.
During activation of electrodes check if there is some solid or any fat material in serum. Please
process serum properly.

Convergys ® ISE User's Manual 45


MAINTENANCE

6.3 ELECTRODES NORMAL RANGE

1. Every electrode should meet the following parameter in 1-point calibration (mV model)

Cal-1 K channel Na channel Cl channel Ca channel Li channel pH channel


Typical voltage 40~100 40~120 40~120 40~100 40~100 40~120
Normal range
10~180 10~180 10~180 10~180 10~180 10~180
(mV)

2. Voltage difference between Cal-1 and Cal-2 should meet the following data in 2-point
calibration (mV model)

Cal-2-Cal-1 K channel Na channel Cl channel Ca channel Li channel pH channel


Typical(∆mV) +16.0 -5.5 +6.0 +8.0 -8.5 +24.0
Normal range
+10~+20 -3~-9 +3~+8 +4~+12 -3~-20 +10~+30
(∆mV)

3. Electrode Slope should meet the following data (mV model)

Electrode K channel Na channel Cl channel Ca channel Li channel pH channel


Slope (S)
Normal range
~33-66 ~30-80 ~30-65 ~12-36 ~30-60 ~25-70
(∆mV)

46 Convergys ® ISE User's Manual


7 PACK LIST

7.1 ELECTRODES

Products No. Description Quantity


1100-1004 K+ Electrode 1pc
1100-1005 Na+ Electrode 1pc
1100-1006 Cl-Electrode 1pc (depending on configuration)
1100-1008 Ca++ Electrode 1pc (depending on configuration)
1100-1009 pH Electrode 1pc (depending on configuration)
1100-1007 Li+ Electrode 1pc (depending on configuration)
1100-1010 Reference Electrode 1pc

7.2 REAGENTS

Products No. Description Quantity


1100-1014 1-point solution(CAL-1 calibration) 4 bottles (480ml)
1100-1015 2-point solution (CAL-2 calibration) 1 bottle (200ml)
1100-1011 Electrode filling solution 1 bottle (10ml)
1100-1013 Reference electrode filling solution 1 bottle (10ml)
1100-1012 Cleaning solution 1 kit

7.3 ACCESSORIES

Name Quantity
Waste bottle 1 bottle
Spare pump tube 1 pcs
Spare fuses 2 pcs
Cleaning needle 1 pcs
Printer paper roll 4 pcs
Power cable 1 pcs
Grounding cable 1 pcs
User Manual (English) 1 pcs
QC Pass 1 pcs

Convergys ® ISE User's Manual 47


Installation Card for Convergys ® ISE comfort Electrolyte Analyzer

Serial Installation
Model Engineer
No. Date

Customer Name Contact

Fax
Phone
Customer
address Telex
Mail Code

Fixed value QC (SERUM) patch number:

Target: K+ Na+ Cl- Ca++ pH Li+

Test K+ Na+ Cl- Ca++ pH Li+


Results
X: (mmol/L)

SD: (mmol/L)

CV: (%)

Comments
on this
installation

Signature of
Engineer Signature of Customer

K+ Na+ Cl- Ca++ pH Li+

Electrode
Serial No.
Remarks
Slope

Intercept
STAMP
(one for customer, one for distributor)

*Attentions and notes for installation:

1. Check grounding condition 4. Different Serum Container

2. Power stabilizer Y/N 5. Maintain time ____ day ____

3. Serum separation Y/N 6. QC technique: Good/ / Common

It is recommended to install a power stabilizer for this analyzer. It is the customer’s own risk of not installing
a stabilizer with fluctuating power supply.

Please return one copy of this installation card to Convergent Technologies.


Installation Card for Convergys ® ISE comfort Electrolyte Analyzer

Serial Installation
Model Engineer
No. Date

Customer Name Contact

Fax
Phone
Customer
address Telex
Mail Code

Fixed value QC (SERUM) patch number:

Target: K+ Na+ Cl- Ca++ pH Li+

Test K+ Na+ Cl- Ca++ pH Li+


Results
X: (mmol/L)

SD: (mmol/L)

CV: (%)

Comments
on this
installation

Signature of
Engineer Signature of Customer

K+ Na+ Cl- Ca++ pH Li+

Electrode
Serial No.
Remarks
Slope

Intercept
STAMP
(one for customer, one for distributor)

*Attentions and notes for installation:

1. Check grounding condition 4. Different Serum Container

2. Power stabilizer Y/N 5. Maintain time ____ day ____

3. Serum separation Y/N 6. QC technique: Good/ / Common

It is recommended to install a power stabilizer for this analyzer. It is the customer’s own risk of not installing
a stabilizer with fluctuating power supply.

Please return one copy of this installation card to Convergent Technologies.


Convergent Technologies GmbH & Co. KG
Ringstraße 14, D-35091 Coelbe, Germany
Tel: +49 6421 8869948 | Fax: +49 6421 8869958
Homepage: www.convergent-technologies.de
e-mail: info@convergent-technologies.de

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