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 \EDIC@ ISE Module
Applications Manual

Electrolyte Measurement System

Rev. 2
ISE Module
Electrolyte Measurement System

Applications Manual

\EDIC@
Medica Corporation
Products for Health Care

©2009 Medica Corporation

©2009 Medica Corporation (all rights reserved)

No part of this manual or the products it describes may be reproduced by any member or in any form without prior consent
in writing from Medica Corporation.

The Medica ISE Module is for In Vitro Diagnostic Use.

Medica Corporation, 5 Oak Park Drive, Bedford, MA 01730-1413 USA

The information in this manual was correct at the time of printing. However, Medica Corporation continues to improve
products and reserves the right to change the specifications, equipment, and maintenance procedures at any time without
notice.
ISE Applications Manual Contents

Quick Start Guide............................................................................................. 1

ISE Module Demo Kit.................................................................................................................. 1
Figure A / Communications Settings.................................................................................... 2
Figure B / ISE Front View.................................................................................................... 3
Figure C / ISE Rear View.................................................................................................... 4
Figure D / Ground Wire Connection................................................................................... 5
Figure E / ISE Module........................................................................................................ 6

Product Description........................................................................................... 7
Overview................................................................................................................................... 7
Intended Use............................................................................................................................... 7
Regulatory Status........................................................................................................................ 7
Consultation .............................................................................................................................. 8
Key Areas to be Resolved by OEM Customer's Design Team.......................................................... 8
Electrodes................................................................................................................................... 10
Fluid Management...................................................................................................................... 10
ISE Module Features and Benefits................................................................................................. 11
Technical Specifications............................................................................................................... 12
Test Ranges................................................................................................................................. 12
Statistical Characteristics.............................................................................................................. 13
ISE Theory . ............................................................................................................................... 15
Figure F / Electrode Measurement Diagram......................................................................... 17

System Features................................................................................................ 20
Mechanical Features................................................................................................................... 20
Figure G / Interconnection Diagram/Wiring........................................................................ 21
Figure H / Interconnection Diagram/Tubing......................................................................... 22
Figure I / Mchanical Dimensions (in inches)......................................................................... 23
Electronic Features...................................................................................................................... 24
Figure J / Block Diagram.................................................................................................... 24
Figure K / Connector Pin Out.............................................................................................. 25
Figure L / Interconnection Cable Wiring Diagram................................................................ 26
Software Features....................................................................................................................... 27
Communication Line Functions..................................................................................................... 27
RS-232 Protocol.......................................................................................................................... 27
Seria Data Input RXD.................................................................................................................. 27
Command Description Table........................................................................................................ 28
Serial Data Output TXD............................................................................................................... 29
Debug Mode Error Response Table............................................................................................... 30
Software Update Procedure......................................................................................................... 31
Communication Notes................................................................................................................. 32
Data Link Escape........................................................................................................................ 32
Module to Host Handshaking....................................................................................................... 33
Figure M / Module Side Synchronization............................................................................. 33
ISE Reagent Data........................................................................................................................ 33
 System Integration Notes................................................................................ 34
Electrical/Grounding Issues......................................................................................................... 34
Tubing........................................................................................................................................ 34
Sample Aspirating and Dispensing............................................................................................... 34
Performance Evaluation............................................................................................................... 35
Matrix Effects.............................................................................................................................. 36
Sample Handling and Collection.................................................................................................. 37
Urine Samples............................................................................................................................ 38
Operating Cycles........................................................................................................................ 38
Calibration Cycle........................................................................................................................ 38
Serum Cycle............................................................................................................................... 39
Urine Cycle................................................................................................................................. 39
Clean Cycle................................................................................................................................ 40
Purge A Cycle............................................................................................................................. 40
Purge B Cycle............................................................................................................................. 41
Sip Cycle.................................................................................................................................... 41
Maintenance Cycle...................................................................................................................... 42
Pump Calibration Cycle............................................................................................................... 42
Debug Cycle............................................................................................................................... 43
Dispensing Cal A Cycle............................................................................................................... 43
Dispensing Cal B Cycle............................................................................................................... 44
Bubble Cal Cycle........................................................................................................................ 44
Prime A Cycle............................................................................................................................. 44
Prime B Cycle............................................................................................................................. 44
Last Result................................................................................................................................... 44
Cycle Charts............................................................................................................................... 45

Maintenance...................................................................................................... 49
Maintenance Schedule................................................................................................................ 49
Recommended Component Replacement Schedule (low volume user).............................................. 49
Recommended Component Replacement Schedule (high volume user)............................................ 49
Shutdown Procedure................................................................................................................... 50

Troubleshooting................................................................................................ 51
Overview................................................................................................................................... 51
Communication Errors................................................................................................................. 51
Fluid Delivery............................................................................................................................. 51
Electrode Stability....................................................................................................................... 52

Troubleshooting Guide..................................................................................... 53
Error Codes................................................................................................................................ 57
Error Codes in Result Strings........................................................................................................ 57
Independent Error Codes............................................................................................................. 57

Appendices:
Appendix A / ISE Module Error Messages................................................................................... 58
Appendix B / Formulation Solutions............................................................................................. 59
Appendix C / ASCII Character Codes.......................................................................................... 61

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Quick Start Guide
ISE Module Demo Kit

The operation of the ISE Module can be demonstrated by connecting it to a standard PC with a
special demonstration cable and power supply provided by Medica.
The following details the procedure to operate the ISE Module:
1. Copy all files to computer from CD supplied.
2. Open the Terminal.exe file.
3. From Terminal window, select File, Open and select the Demo.trm file. Demo terminal window
should now be open.
4. Verify communications settings (see Figure A). Select Communication port.
5. Connect the Calibrant A pump, Calibrant B pump, and waste pump tubing to the ISE Module
(see Figure B).
6. Connect the interface cable to the serial I/O port of the PC (see Figure C).
7. Connect ground wire to rear of demo bracket (see Figure D).
8. Depress the compression plate. Install electrodes in positions shown in Figure E.
9. Click on <ISE?> to confirm communication with the ISE Module. The response should be
<ISE!>. If not, troubleshoot the connections.
10. Install the reagent module. Condition the electrodes by requesting multiple <PRMA> cycles
by clicking on the Purge/Position A button in Level 2 of the Terminal Program. When the
ISE Module transmits <ISE!> with no associated error codes back to the host, Calibrant A
has filled all tubing and electrodes. Repeat this process for Calibrant B using the <PRMB>
command. Request 3 additional <PUGA> cycles after tubing is primed. Allow the electrodes
to be exposed to fluid for 15 minutes before calibrating.
11. C
 alibrate the ISE Module by clicking on the Bubble Cal button. Click on the Pump Cal
button, dispense 100 µL of Calibrant A, and then click the start button. Finally, click on the
Cal B button.
12. If the results from the Module are unacceptable, refer to the Troubleshooting Guide for
assistance.
If you have any questions or problems operating the ISE Module, please contact Technical
Service, 800-777-5983 (within U.S.) or 781-275-4892 (international) or email techsupport@
medicacorp.com.

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FIGURE A
COMMUNICATIONS SETTINGS

Communications X

Baud Rate
OK
110 300 600 1200
2400 4800 9600 19200 Cancel

Data Bits Stop Bits

5 6 7 8 1 1.5 2

Parity Flow Control Connector

None Xon/Xoff None
Odd Hardware COM1:
Even None COM2:

Mark
Space Parity Check Carrier Detect

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FIGURE B
ISE FRONT VIEW

ISE Module Communication Cable Reagent Connector

Power Supply Platen Pumps Demo Bracket Reagent Module

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FIGURE C
ISE REAR VIEW

Reagent Connector Reagent Module Reagent Tubing

Communication Port Power Supply Communication Cable Pumps

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FIGURE D
GROUND WIRE CONNECTION

Ground Wire Connection

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FIGURE E
ISE MODULE
Sample Entry Port

Calirbant A Port

Calibrant B Port

Mounting Bosses

Li+ Electrode
Bubble Detector

Na+ Electrode

K+ Electrode

Cl- Electrode
Housing

Reference Electrode
Compression Plate

Detail of Right Angle

Adapter

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Product Description

Overview
Medica’s ISE Module includes ion-selective electrodes and three peristaltic pumps designed to be
mounted within an existing chemistry analyzer. The ISE Module measures the concentration of Li+,
Na+, K+, and Cl- in serum, plasma and diluted urine. An integral sample entry port is positioned
on top of the ISE Module. This compact design allows for small sample size and fast operation. The
Module requires a minimum sample size of 70 μL.
The ISE Module houses snap-in, snap-out electrodes which connect directly to an electronic board
within the ISE Module. This eliminates the need for cables and minimizes electrical noise. Samples
and calibrators are positioned in front of the electrodes by three peristaltic pumps. Two separate
pumps move Calibrant A and Calibrant B into the ISE Module’s sample entry port and a waste
pump positions samples and calibrants in front of the electrodes. The sample is deposited by the host
analyzer into the sample entry port. After each sample measurement, calibrant is positioned in front
of the electrodes for a single-point calibration. The removal of protein build-up on the electrodes and
fluid path is accomplished by the use of cleaning solution. Cleaning solution is placed in a cup on the
host analyzer sample tray, aspirated, and deposited into the sample entry port by the host analyzer.
The ISE Module is completely self contained. All sample and calibrant positioning within the ISE
Module is controlled by an integral microprocessor. The ISE Module’s microprocessor applies
mathematical algorithms to electrode output voltages, converting them to clinical units of mmol/L.
These data are communicated over serial communication lines to the host analyzer. The ISE Module is
a solution to providing electrolyte measurement capabilities to any chemistry analyzer

Intended Use
The ISE Module is used as a component of other diagnostic test systems, including chemistry
analyzers. It measures lithium, sodium, potassium, and chloride and transmits the results of these
measurements to the host analyzer for integration into other reported test results.

Regulatory Status
The manufacturer of the chemistry analyzer, of which the ISE Module is an integral part, must obtain
regulatory approvals before the analyzer can be used for commercial distribution.

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Consultation
The basic methodology and certain guidelines for use of the ISE Module are outlined in this
Applications Manual. While this manual attempts to delineate the necessary and sufficient condi-
tions under which the ISE Module must be used, there are many subtleties associated with elec-
trolyte measurements using ISE technology that are not necessarily well understood by the OEM
customer.
The installation requirements for a host analyzer differ according to the specific design of the
particular host analyzer. Installation success depends on the fundamental understanding of ISE
technology-based instrumentation by the OEM design team. Medica has substantial experience
in this application. Medica’s participation in the design of the interface between the host analyzer
and the ISE Module is essential to ensure proper performance. While the applications manual is
designed to assist the host analyzer team, it is a guideline only.
Medica will provide preliminary technical information to the OEM design team; however, it cannot
design and debug the interface between the ISE Module and the host analyzer. If desired, Medica
will enter into a consulting agreement to assist OEMs with the integration effort. Contact Medica’s
Sales Department for details.

Key Areas to be Resolved by the OEM Customer’s Design Team

As part of the ISE Module integration process, the OEM design team should be certain that the
following design elements are considered.
• Error code handling:
–Host analyzer is responsible for ensuring only valid results are reported (see Error Codes in
the Troubleshooting section of this manual).
–Host analyzer should either flag or blank out results after an unsuccessful calibration, or
results with an error code.
• Medica’s ISE Module follows the instructions of the host analyzer. Error codes are produced by
the ISE Module when certain criteria are not met; i.e., range, drift, noise, etc. However, it is the
responsibility of the OEM design team to ensure that the host analyzer properly responds to the
error codes transmitted from the ISE Module to ensure the integrity of the results.
• It is the responsibility of the OEM design team to determine if there are any interferences from
EMI or RFI.
• Grounding and shielding issues need to be identified and resolved.
• Sample handling
- Sample segmentation must be optimized (See Sample Aspirating and Dispensing under
System Integration Notes).
- Aspiration rate must be optimized.
- Dispense rate must be optimized.
- Sample carryover must be minimized (See System Integration Notes).
- Sample dilution must be minimized (See System Integration Notes).

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• The on-board use life of reagents must be determined.

• An algorithm (correlation factor) for all analytes must be developed.
• The temperature of the environment in which the ISE Module is positioned should not vary more
than ± 4° C. Temperature should not exceed 32C. Temperature above
32° C may affect use life of sensors.
• Air bubbles in samples must be eliminated.

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Electrodes
Medica electrodes are maintenance-free. Electrode packages are marked with an “Install-by
date.” Cleaning solution, aspirated from a host analyzer sample cup, should be used at least
once a day at the end of the work day to minimize protein buildup in the fluid lines and elec-
trodes. A pump calibration should be performed each day. Perform a two-point calibration every
8 hours. If the user is running more than 50 serum samples a day, both cleaning and two-point
calibration must be performed after every 50 samples. To ensure reliable operation, the ISE
Module performs calibrant sipping every 30 minutes, beginning after the last sample is run. This
function is completely controlled by the ISE Module.
The ISE Module utilizes a double-junction reference electrode. The reference electrode is filled
with saturated KCl. If the concentration of the reference electrode reservoir drops below 3.0M
KCl, serious errors will result in the measured electrolyte concentrations. The reference electrode
contains a small red sphere in the reservoir which normally resides on top of the filling solution. If
the sphere begins to sink, the reference electrode must be replaced.
When measuring urine, the sample must be accurately diluted (1 part sample to 9 parts Medica
urine diluent). The dilution must be performed before the sample is dispensed into the sample
entry port.

Fluid Management
The sample is aspirated by the host analyzer from a sample cup and dispensed into the sample
entry port on top of the ISE Module. The sample is then positioned in front of the electrodes for
measurement.
Four solutions are required to operate the ISE Module.
1. Calibrant A is used in both two-point and single-point calibrations for serum sample
analysis. Calibrant A is pumped into the sample entry port by the Calibrant A pump and then
positioned in front of the electrodes by the waste pump. Calibrant A solution is also used for
Pump and Bubble Calibration.
Calibrant A Solution
Li+ 1.0 mmol/L
Na+ 140 mmol/L
K+ 4.0 mmol/L
Cl- 125 mmol/L
2. Calibrant B is used in two-point and single-point calibrations for urine sample analysis.
Calibrant B is pumped into the sample entry port by the Calibrant B pump and then positioned in
front of the electrodes by the waste pump.
Calibrant B Solution
Li+ 0.4 mmol/L
Na+ 70 mmol/L
K+ 8.0 mmol/L
Cl- 41 mmol/L

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3. Cleaning Solution is used once a day to prevent protein buildup on the electrodes and
fluid path. It must be used more frequently if the ISE Module performs greater than 50 sample
measurements per day. 100 μL of cleaning solution must be aspirated by the host analyzer from a
sample cup on the host analyzer and dispensed into the sample entry port. The sample cup must be
covered to eliminate evaporation.
NOTE: Medica pepsin/HCl cleaning solution must be prepared every four weeks and stored at 4º C.
4. Medica Urine Diluent. Urine samples must be diluted to perform urine measurement: 1
part urine sample to 9 parts urine diluent. The diluted specimen must be thoroughly mixed before
aspirating a sample.
Initiate a Maintenance Cycle <MANT> before changing the reagent pack. After the new source of
Calibrant A or Calibrant B is connected, the user must initiate both <PRMA> and <PRMB> cycles to
eliminate air from the fluid lines.
The ISE Module does not measure the actual volume of Calibrant A or Calibrant B remaining in the
reagent pack. Instead, the host analyzer must provide this function by maintaining a record of the
number of samples, sips, cleans and calibrations performed by the ISE Module. See details on each
cycle for volumes used in the Operating Cycles section of System Integration Notes. Pack usage data
can be stored in the reagent pack. See details in “Communications Protocols for ISE Data.”
The ISE Module sends information to the host analyzer when sample readings are taken and when a
Cleaning, Sipping, or Calibration Cycle is performed. All signals are communicated to and from the
ISE Module over the RS-232/ASCII

ISE Module Features and Benefits

Features Benefits

Integral Sample Entry Port Minimal Sample Carryover

Small Sample Size 70 μL
Electrodes Mounted Close to Electronics Minimal electronic noise improves
precision
Sample Entry Ports are in line with ISE Electrodes Minimal Sample Size and Carryover
Rapid Operation (35 Sec Cycle Time) Rapid electrolyte results
Easy to access electrodes Simple Maintenance
No maintenance electrodes No Maintenance performed by lab
personnel
Easily accessible pumps Simple maintenance
Bubble detector Reliable sample positioning assured
Two-point calibration High accuracy, precision, and ensures
ISE Module stability
One-point calibration with every sample High accuracy, precision, and ensures
ISE Module stability
Maintenance free electrodes Low cost per test, only periodic
cleaning

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Technical Specifications

The technical specifications below describe performance of the ISE Module when mounted in the test fixture
provided by Medica. When the ISE Module is mounted in a host analyzer, performance specifications will need
to be reestablished by the OEM manufacturer.

Sample: Serum, Plasma, or Urine (Urine requires dilution)

Minimum Sample Size: 70 μL serum; 140 μL diluted urine
Maximum Sample Size: 150 μL serum; 150 (x2) μL diluted urine
Analysis Time: serum – <28–33> seconds after the <STRT> command,
including one point calibration
urine – <34.5–43.5> seconds after the <STRT> command,
including one point calibration
Throughput: serum – 100 samples/hour
urine – 90 samples/hour
Power: 24VDC, 1.0A
Module Size: 161 mm high x 65.5 mm wide x 98.6 mm deep
Reagent Pack Size: 137.9 mm high x 190.5 mm wide x 63 mm deep
Reagent Connector Size: 48 mm high x 99 mm wide x 29 mm deep
Reagent Pack Calibrant A
Includes: Calibrant B
Waste Storage (optional)
Other Reagents: Cleaning Solution
Urine Diluent
Environmental Temperature Range: 15–32°C

Test Ranges
Analyte Units Test Range limits Resolution of Results

(Whole blood, serum, plasma)

Li+ mmol/L 0.20 – 3.50 0.01

Na+ mmol/L 100.0 – 200. 0 0.1
K+ mmol/L 1.00 – 10.00 0.01
Cl- mmol/L 50.0 – 150.0 0.1
(Urine)
Na+ mmol/L 10 – 500 1
K+ mmol/L 5 – 200 1
Cl- mmol/L 15 – 400 1

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Statistical Characteristics
Stand Alone ISE Module Correlation to Medica’s EasyElectrolyte analyzer

Analyte Correlation Coefficient Slope

Li+ 0.99 1.0+/-0.133

Na+ 0.99 1.0+/-.05
K+ 0.99 1.0+/-.05
Cl- 0.99 1.0+/-.05

Stand Alone ISE Module Accuracy by Test Range

Analyte Level Standard Range Accuracy Units

Method Plus/minus

Li+ Low EEL Li+ 0.2–0.6 0.1 mmol/L

Normal EEL Li+ 0.6–2.0 0.1 mmol/L
High EEL Li+ 2.0–3.5 0.2 mmol/L

Na+ Low EEL Li+ 100.0–136.0 3.0 mmol/L

Normal EEL Li+ 136.0–146.0 2.5 mmol/L
High EEL Li+ 146.0–175.0 3.0 mmol/L
Very High EEL Li+ 175.0–200.0 4.0 mmol/L

K+ Low EEL Li+ 1.0–3.5 0.2 mmol/L

Normal EEL Li+ 3.5–5.1 0.1 mmol/L
High EEL Li+ 5.1–7.0 0.1 mmol/L
Very High EEL Li+ 7.0–10.0 0.2 mmol/L

Cl- Low EEL Cl- 50.0–90.0 3.0 mmol/L

Normal EEL Cl- 90.0–120.0 2.0 mmol/L
High EEL Cl- 120.0–150.0 3.0 mmol/L

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Stand Alone ISE Module Precision by Test Range — Serum, Plasma

Within Run Day to Day
Analyte Units Range CV (%) SD CV (%) SD

Li+ mmol/L 0.6–1.6 3.0 5

mmol/L 0.2–0.6 0.03 0.05
mmol/L 1.6–3.5 2.0 3

Na+ mmol/L 136.0–146.0 1.0 2

mmol/L 100.0–136.0 1.6 3.2
mmol/L 146.0–160.0 1.5 3

K+ mmol/L 3.5–5.1 1.5 2

mmol/L 2.0–3.5 0.05 0.06
mmol/L 5.1–6.0 2.0 2.5

Cl- mmol/L 98.0–106.0 1.5 1.8

mmol/L 80.0–98.0 2 2.5
mmol/L 106.0–120.0 1.7 2

Stand Alone ISE Module Precision by Test Range, Urine

Within Run Day to Day
Analyte Units Range CV (%) SD CV (%) SD

Na+ mmol/L 10.0–149.0 3.5 5.0

mmol/L 150.0–300.0 3.5 5.0

K+ mmol/L 2.0–79.0 3.5 5.0

mmol/L 80.0–200.0 3.5 5.0

Cl- mmol/L 15.0–149.0 3.5 5.0

mmol/L 150.0–400.0 3.5 5.0

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ISE Theory
Electrolyte measurements in blood products were traditionally performed using flame
photometry. Using this method, a sample that has been diluted with a known concentration of
a reference ion (usually lithium or cesium) is aerosolized and passed through a flame which
excites the cations. They re-emit the energy as light of different frequencies; the amplitude
of this emission is proportional to the ion concentration in the sample. The development
of selective organic compounds for sodium, potassium, chloride, and other electrolytes
has permitted the development of sensors capable of directly measuring biological fluids
throughout the physiological range. These sensors are known as ion-selective electrodes.
The Medica ISE Module measures lithium, sodium, potassium,and chloride in biological fluids,
using ion-selective electrode technology. A diagram of the electrode measurement system is
shown in Figure C. The flow-through sodium electrode uses a selective membrane, specially
formulated to be sensitive to sodium ions. The potassium, lithium, and chloride electrodes
employ similar designs with appropriate selective membrane materials. The potential of each
electrode is measured relative to a fixed, stable voltage established by the double-junction
silver/silver chloride reference electrode. An ion-selective electrode develops a voltage that
varies with the concentration of the ion to which it responds. The relationship between the
voltage developed and the concentration of the sensed ion is logarithmic, as expressed by the
Nernst equation:

E x =E s +RT log (∝ C)
nF
where: Ex = The potential of the electrode in sample solution
Es = The potential developed under standard conditions
RT/nF = A temperature dependent “constant”, termed the slope(s)
log = Base ten logarithm function
∝ = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution

A comparative method of measurement is utilized. First, the ISE module measures the
potentials developed when the sample is positioned in the electrodes. Next, Calibrant A is
positioned in the electrodes. The difference in the two potentials is related logarithmically to the
concentration of the measured ions in the sample divided by their respective concentrations in

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the Calibrant solution. Since the difference in potentials and the concentration of the sodium, potassium or
other ions in the Calibrant solution are known, the computer can calculate the concentration of the ions in
the sample solution, in accordance with the Nernst equation, rewritten as:

E x - E s = S log (C x /Cs) or C x =C s x 10^ [ (E x - E s )/S ]

where: Ex = ISE potential developed in sample solution

Es = ISE potential developed in the Calibrant solution
S = Electrode slope calculated during calibration
Cx = Concentration of ion in the sample
Cs = Concentration of ion in the Calibrant solution

“S”, the slope, is determined during calibration using Calibrants A and B, which have known levels of
sodium, potassium, and chloride.
When a two-point calibration is initiated, the slope is calculated from the difference between the second
Calibrant A reading and the Calibrant B reading. Excessive drift or noisy readings will be flagged and the
appropriate error message sent to the host analyzer from the ISE Module.

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Figure F
ELECTRODE MEASUREMENT DIAGRAM

Sample Entry Port

Calibrant A Port
Calibrant B Port

Bubble Detector Optically

Detects Air Bubble in Flow

Sample Flow Path

Ionic Contact through Saturated KCl

Internal Filling Solution

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The slope is defined as:

Slope = EB - EA

log
()CB
CA

where CA = Calibration A concentration in mmol/L

CB = Calibration B concentration in mmol/L
EA = ISE potential developed in Cal A solution in mV
EB = ISE potential developed in Cal B solution in mV
The ISE Module's electronic processor checks these slopes and an error code is transmitted to the host
analyzer if they are outside the acceptable slope limits. Typical slopes are approximately 55 mV/
decade for Li+, Na+ and K+ and 45 mV/decade for Cl-.
Acceptable Slope Limits are:
Slope (mV/decade)
Li+ 47-64
Na+ 52-64
K+ 52-64
Cl- 40-55
In practice, electrode slopes may be higher than the ideally predicted value of 59.2 mV/decade at
25° C. Higher operating temperatures, interfering ions and other factors can raise the observed slope
significantly.
The slope changes with temperature. The slope of the electrodes is equal to (RT/nF) = 59.2 at 25° C,
where R is the gas constant, T is the temperature in degrees K, n is the valence of the ion, and F is
Faraday constant. If all of the factors are constant except T, one can calculate the ideal slope of the
electrodes based on the temperature. Some examples of predicted slopes vs. temperature are listed
below.
Temp. (in deg. C) Slope (mV/decade)
20 58.2
22 58.6
24 59.0
26 59.4
28 59.8
30 60.2
32 60.6

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If the module is calibrated at any temperature within its specification, and the same
temperature is maintained during sample analysis, no error in the measurement will occur.
Errors will occur only when calibration and sample analysis are performed at different
temperatures.
As electrodes age, slopes will decrease. Medica’s lower limits for acceptable slopes are set at
the lowest value that insures good analyzer precision.
The values of slopes between calibrations performed successively (one after the other) should
not differ by more than 1.5 mV/decade for any of the channels, (Li+, Na+, K+, or Cl-).

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 System Features

Mechanical Features
A photograph of the ISE Module appears in Figure E. The ISE Module contains the ion-selective
electrodes and the reference electrode. A bubble detector is also included at the top of the electrodes.
This is used to properly position the sample in front of the electrodes for measurement. A sample entry
port is positioned at the top of the ISE Module. This permits a convenient sample entry location for the
host analyzer. The three pumps that position the sample and wash/calibrating solutions are shown in
Figure G. These pumps can be mounted remotely from the ISE Module in the host chemistry analyzer
(not more than 25 inches from the ISE Module) (Figure G). A waste container can be provided by the
host analyzer or included in the reagent module. Calibrant A and Calibrant B are packaged in foil
pouches within the reagent module. Positioning of this reagent module is at the discretion of the host
analyzer designer. Urine diluent can be packaged in 125 mL or 500 mL quantities in high density
polyethylene containers.
An electronic signal processing board is attached to the ISE Module. This board includes high input
impedance operational amplifiers to detect the ISE signals. A second board has additional digital
processing circuitry serving as an A/D converter and providing an ASCII signal output to the
chemistry analyzer.
Various mounting options are available for the ISE Module. The ISE Module can either be secured to
the host analyzer chassis or mounted within a custom designed bracket which is then mounted to the
host analyzer chassis using two #6-32 x 0.375 Phillips head screws (see Figure E, mounting bosses).
This permits easy removal of the entire ISE Module from the analyzer for maintenance.
Each of the electrodes can be easily installed or removed from the front of the housing as shown in
Figure H. The ISE Module should be installed in a location where electrodes are easily accessible.
Mechanical dimensions of the ISE Module and associated pumps are shown in Figure I.

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FIGURE G
INTERCONNECTION DIAGRAM/WIRING

Dallas Chip
Connector
Reagent
24V Power Supply

Interface Cable
Serial Port

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 o s y s t e m o p e r a t i o n

FIGURE H

INTERCONNECTION DIAGRAM/TUBING

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 s y s t e m o p e r a t i o n n

FIGURE I

MECHANICAL DIMENSIONS (in inches)

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 o s y s t e m o p e r a t i o n

Electronic Features

General Description
The ISE Module electronics include all pre-amplifiers and microprocessor controls for the
fluid pumps, A/D converter and RS-232C communications. The microprocessor applies
mathematical algorithms to electrode sensor output voltages, converting them to clinical
units of mmol/L. The electronics board requires 24 volts, 1.0 amps to operate. A block
diagram (Figure J) of the ISE Module appears below:

Figure J
Block Diagram - ISE Electronics

Bubble Detector

Li+ Input

Na+ Input

K+ Input

Cl- Input

Ref. Input

24V

Sensor Inputs
There are 6 sensor input lines for:
Bubble Detector
Li+ Electrode
Na+ Electrode
K+ Electrode
Cl- Electrode
Reference Electrode

Connections
Refer to Figure K for the pin outs of the 40-pin connector used on the ISE Module’s main
PCB. Refer to Figure L for the wiring diagram of the interconnection cable provided with
the demo ISE Module.

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 s y s t e m o p e r a t i o n n

Figure K: Connector Pin Out

SIGNAL 40 DUAL Pin # DB-9 BUTTON Waste Cal-A Cal-B PWR

GND P1 1 SHELL
DATA P1 2 PIN
MAPHA P1 3 6
P1 4 6
MAPHB P1 5 4
P1 6 4
MAPHC P1 7 3
P1 8 3
MAPHD P1 9 1
P1 10 1
MBPHA P1 11 6
P1 12 6
MBPHB P1 13 4
P1 14 4
MBPHC P1 15 3
P1 16 3
MBPHD P1 17 1
P1 18 1
MWPHA P1 19 6
P1 20 6
MWPHB P1 21 4
P1 22 4
MWPHC P1 23 3
P1 24 3
MWPHD P1 25 1
P1 26 1
+24V P1 27 T1
+24V P1 28 T1
MGND P1 29 T2
GND P1 31 5
NC P1 32 9
CPU_RESET P1 33 N.G.
RTS P1 34 8
RXD_IN P1 35 3
CTS P1 36 7
TXD_OUT P1 37 2
NC P1 38 6
P1 39 1
P1 40 N.G.

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 o s y s t e m o p e r a t i o n

Figure L
INTERCONNECTION CABLE WIRING DIAGRAM

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 s y s t e m o p e r a t i o n n

Software Features

Communication Line Functions

There are 5 communications lines:
Serial Data Input RXD Port
Serial Data Output TXD Port
CTS
RTS
Ground

RS 232 Protocol:
Baud Rate = 19200
StopBits = 1
Data Bits = 8
Parity = None
The signal level of the two RS-232 communication lines is nominally +/- 8V.

Serial Data Input RXD:

The ISE Module is equipped with an ASCII encoded input line.
The following data is transmitted to the ISE Module by the host analyzer on this line in ASCII format
using the character sequence as shown in the Command Description table.

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 o s y s t e m o p e r a t i o n

Command Description Table

Command Label Command String Command Description

CALB <CALB> - 2 point calibration

SAMPLE <SAMP> - Empties flow-path for Serum Sample cycle
URINE ONE <UWBW> - Empties flow-path with Calibrant B washouts for
Urine Sample Cycle
URINE TWO <UNBW> - Empties flow-path without Calibrant B washouts
for Urine Sample Cycle
CLEAN <CLEN> - Empties flow-path for Cleaning Cycle
PUMP CAL <PMCL> - Empties flow-path for Pump Calibration Cycle
START <STRT> - Start Sample, Urine, Clean or Pump Cal
Purge/Position A <PUGA> - Empties flow-path, dispenses100 μL Calibrant A
and positions it in front of electrodes
Purge/Position B <PUGB> - Empties flow-path, dispenses 100 μL Calibrant B
and positions it in front of electrodes
Bubble Cal <BBCL> - Bubble Calibration
Show Bubble Cal <SWBC> - Show last bubble calibration values
Show Pump Cal <SWPC> - Show last pump calibration values
DSPA 200μL Calibrant A <DSPA_200> - Pump 200 uL of Calibrant A into Sample Inlet Port.
DSPB 200μL Calibrant B <DISB_200> - Pump 200 uL of Calibrant B into Sample Inlet Port.
Version/Checksum <CKSM> - Request to show ISE software checksum version
Read mV <RDMV> - Read mV of all four channels
Show last slopes <SWCS> - Show last calibration slopes
Debug mV ON -One <DVON> - Set debug mV ON
Debug mV ON - Two <MVON> - Set debug mode mV ON – No mV in Sipping Cycle
Debug mV OFF <DVFF> - Set debug mV OFF
Maintenance <MANT> - Empties flow-path and NO Sipping Cycle
Prime Cal A <PRMA> - Empties flow path, dispenses 300 μL Cal A and
positions it in front of electrodes
Prime Cal B <PRMB> - Empties flow path, dispenses 300 μL Cal B and
positions it in front of electrodes
Read 0 <DLRD_00> Reads page 0 of Dallas chip
Read 1 <DLRD_01> Reads page 1 of Dallas chip
WRITE <DLWR_01> Write to Dallas chip

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 s y s t e m o p e r a t i o n n

Serial Data Output TXD

The ISE Module is equipped with an ASCII encoded output line.
The following data is transmitted from the ISE Module on this line in ASCII format using the character sequence
shown.

Command and Response Table

Command Label Response Messages

CALB 1- <CAL Li xx.xx Na xx.xx K xx.xx Cl xx.xx eeeeeeec>
2- <CAL Li xx.xx Na xx.xx K xx.xx Cl xx.xx eeeeeeec>
SAMPLE <ISE!>
START <SER Li xx.xx Na xxx.x K xx.xx Cl xxx.x eeeeeeec>
URINE ONE <ISE!>
URINE TWO <ISE!>
START <URN Na xxxxx K xxxxx Cl xxxxx eeeeeeec>
CLEAN <ISE!>
START <ISE!>
PUMP CAL <ISE!>
START <PMC A xxxx B xxxx W xxxx>
Purge/Position A <ISE!>
Purge/Position B <ISE!>
Bubble Cal <BBC A xxx M xxx L xxx>
Show Bubble Cal <BBC A xxx M xxx L xxx>
Show Pump Cal <PMC A xxxx B xxxx W xxxx>
Prime/Position A <ISE!>
Prime/Position B <ISE!>
DSPA 200μL Calibrant A <ISE!>
DISB 200μL Calibrant B <ISE!>
Version/Checksum <ISV cccc>
Read mV <AMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
Show last slopes <CAL Li xx.xx Na xx.xx K xx.xx Cl xx.xx> or
<BMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
Debug mV ON -One <ISE!>
Debug mV ON -Two <ISE!>
Debug mV OFF <ISE!>
Maintenance <ISE!>

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 o s y s t e m o p e r a t i o n

Debug Mode/Errors Response Table

Condition Cycle Response Messages
Debug Mode -Calibration 1 -<BMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
One Or Two 2 -<AMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
3-<CAL Li xx.xx Na xx.xx K xx.xx Cl xx.xx eeeeeeec>
4-<BMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
5-<AMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
6-<CAL Li xx.xx Na xx.xx K xx.xx Cl xx.xx eeeeeeec>
-Sample/Start 1-<SMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
2-<AMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>
3-<SER Li xx.xx Na xxx.x K xx.xx Cl xxx.x eeeeeeec>
-Urine1/Urine2/Start 1-<UMV Na xxx.x K xxx.x Cl xxx.x>
2-<BMV Na xxx.x K xxx.x Cl xxx.x>
3-<URN Na xxxxx K xxxxx Cl xxxxx eeeeeeec>

Debug Mode One -Sipping Cycle <AMV Li xxx.x Na xxx.x K xxx.x Cl xxx.x>

Errors -Calibration <ERC CAL x000000>

-Serum Sample <ERC SER x000000>
-Urine Sample <ERC URN x000000>
-Clean <ERC CLE x000000>
-Pump Calibration <ERC PMC x000000>
-Bubble Calibration <ERC BBC x000000>
-Sipping Cycle <ERC SIP x000000>
-Purge/Position Calibrant A <ERC PGA x000000>
-Purge/Position Calibrant B <ERC PGB x000000>
-Read/Write Dallas <ERC DAL x000000>
-Maintenance <ERC MAT x000000>
-Communication <ERC COM x000000>
-No Dallas Chip <ERCDAL N000000>

All serial transmissions are in the form of an ASCII data string. When the ISE Module receives <ISE?>
from the host analyzer, it responds with <ISE!>. The ISE Module also sends this message after successful
completion of any cycle which does not transmit data.
Details regarding the serial data transmission are as follows (see Appendix C):
x = ASCII representation of a numerical value e.g. 140.0 would be 31H, 34H, 30H, 2EH, 30H. Leading
zeros are replaced with a space (20H).
C = binary checksum of all characters in the string with exception of the < (3CH), the > (3EH), and the
checksum itself. (Note: When this binary number is displayed or printed, it may take the form of a
number, letter, blank space, or carriage return.)

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 s y s t e m o p e r a t i o n n

Software Update Procedure

1. Connect ISE Module to PC serial port using standard 9 pin RS232 cable.
2. S
 tore files provided by Medica (xxxx.hex, terminal.exe and download.trm) in a convenient directory on
the hard drive.
 pen termal.exe file. From terminal window, select File —> Open and select the download .trm file.
3. O
Download terminal window will open.
4. Verify communication settings (See Fig. A, below).
5. T urn on the ISE Module and select the Version/Checksum button to confirm communication between PC
and ISE module. ISE module should send <ISV xxxx> otherwise check your communication settings.
6. Select Update Software. <ULS?> will appear on the screen.
7. Select "COMRIM". <WFHF> will appear on the screen.
8. F rom Download terminal screen, select "Transfers" —> "Send Text File." Select the
"xxxx.hex" file.
 oftware will begin loading. Do not turn off ISE Module or click any buttons while loading
9. S
the software.
10. <DONE> will appear on the screen.
11. Select the Version/Check button to verify correct software checksum.

Communications X

Baud Rate
OK
110 300 600 1200
2400 4800 9600 19200 Cancel

Data Bits Stop Bits

5 6 7 8 1 1.5 2

Parity Flow Control Connector

None Xon/Xoff None
Odd Hardware COM1:
Even None COM2:

Mark
Space Parity Check Carrier Detect

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 o s y s t e m o p e r a t i o n

Communication Notes
The position of the final bracket (>) can be affected by the checksum value (see Data Link Escape).
The checksum is calculated by the ISE Module software by adding up all the decimal equivalents of
the ASCII characters. The brackets are not counted in the sum, but the skipped spaces are counted
as 032 for each. Since the ISE Module only prints a single character for the checksum, the value
is “rolled over” as is common in calculating checksums. This value is ALWAYS transmitted as a
number. However, what is printed by a printer or displayed on a monitor is the ASCII equivalent.
Refer to Appendix C. If the checksum value is less than 033 (decimal), the value will not be a
printable ASCII character. Instead, the character may be a command for the printer or display,
such as backspace, line feed, or carriage return. Some of these characters, because of Data Link
Escape (3EH, 10H), will move the location of the final bracket.
Medica expects the host analyzer software to provide range checking of the ISE Module results
where the ranges are programmable (normal ranges, critical ranges, or quality control ranges).
The ISE Module will check for “out of measurement” ranges, for noise, for drift, and other fixed
limits.

Data Link Escape

The checksum can be any value between OH-FFH. To avoid message desynchronization, DLE
encoding is applied to the following values:
3EH ('>')
10H (DLE)
This method simplifies locating message delimiters because the potentially ambiguous checksum
character cannot be mistaken for a delimiter. When the value 3EH or 10H appears as a checksum,
10H is inserted and 40H is added to the checksum. The host should recognize the DLE character
and subtract 40H from the following character.

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 s y s t e m o p e r a t i o n n

Module to Host Handshaking

When the module completes a requested task, it asserts its RTS line. This event indicates the module is
ready to transmit its response. The module will wait up to 5 seconds for its CTS line to be asserted. At
the end of the transmission, the module will deassert its RTS line as shown in the figure below. Contact
Medica’s Technical Service for more details or advice on optimizing your system.

Figure M Module Side Synchronization

CTS Host is ready for data

Host has received all data

RTS
MT

Module has data

MT = Max time = 5 seconds

ISE Reagent Data

The ISE reagent pack uses a memory device in order to store module information. The memory
component is a write-once device. Factory information is stored in part of the memory space. Update
information may be stored in the remaining memory space. Factory information includes such data
as: expiration date, distributor code, module size, lot number, security key, a 16-bit CRC (cylindrical
redundancy check). The update information may include the install date, a means to calculate a
count down of reagent pack usage, and information about why a pack was designated as no longer
acceptable (expiration, no remaining reagent, wrong distributor code).
Note: The communications protocol for the Reagent Pack can be supplied upon request from Medica.

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 System Integration Notes

Electrical/Grounding Issues
Shielding
The ISE Module has been grounded to assure its immunity from conducted and radiated electrical
noise. However, AC fields (from a preheater, if controlled by pulse width modulation, capacitance
sample detection, or motors) can create offsets in the electrodes. Be certain that these fields are
minimized using shielding and by placing AC devices remotely from the ISE Module. Contact Medica’s
Technical Service for more details or advice on optimizing your system.
Grounding
Electrical grounding is extremely important. If static electrical discharges are allowed to enter the fluid
stream, these voltage spikes will polarize the electrodes, resulting in substantial electrode drift. Electrode
recovery may require one or more hours. The power supplied to the ISE Module must be “clean” with
no spikes or drift. It must be well regulated.
Sample level detection by the host analyzer probe, using a conductivity method, can cause a voltage
offset of the electrode readings. This will occur if current is applied while the probe is in contact with
the fluid sample as it is being dispensed into the sample entry port. In this case, dispense above fluid
level or turn power off to the level sensor while dispensing.
The chassis ground of the ISE Module and peristaltic pump motor housings should be connected
directly to the primary ground point of the host analyzer. Noise spikes from the ground or from the
power supply easily find their way into the sensor voltage signal. Due to the high impedance of the
electrodes, even slight voltage spikes can affect the results
Be certain that ground loops are not created when attaching the ISE Module to the host analyzer.
Each host analyzer is different. Test the grounding options for the best choice such as direct chassis
grounding, or grounding through RS232 cable. Contact Medica’s Technical Service for more details or
advice on optimizing your system.

Tubing
The lengths of tubing between the pumps and the ISE Module should be kept as short as possible,
especially the waste tubing. If the waste tube becomes too long, vacuum will develop during the high
flow rate portions of the cycle. This causes sample or calibrant to be pulled past the electrodes, giving
an “air in sample”, “air in Calibrant A,“ or “air in Calibrant B” error. Maximum waste tube length
is <25 inches. Evaporation through the tubing may change calibrant values. To prevent evaporation
of the calibrant, use only tubing obtained from Medica. Contact Medica’s Technical Service for more
details or advice on optimizing your system.

Sample Aspirating and Dispensing

The sample delivered to the ISE Module must not be contaminated or further diluted. The host analyzer
wash solution, usually deionized water, is the most serious contaminant. Sample pickup and delivery to
the ISE Module must be highly controlled and consistent.

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 s y s t e m i n t e g r a t i o n n o t e s n

Aspiration and dispense rates should be as slow as possible (consistent with the sample throughput
requirements of the host analyzer). The faster the aspiration and dispense rate, the more mixing will
occur between the sample and the wash solution. Air segmentation and sample volume can have a very
significant influence on the purity of the sample.
Medica suggests using a combination of air segments and multiple small volume sample segments
(preceding the larger sample segment required for analysis) during aspiration. This helps reduce dilution
of the sample by wash solution. To minimize carryover, the host analyzer should aspirate more sample
than is required by the ISE Module in order to deliver an uncontaminated sample to the ISE Module.
Note that the analyzer should dispose of any excess volume (usually in the wash cup).
The required minimum volume, which should be delivered to the ISE Module for a serum/plasma
sample, is 70 μL. If the delivered sample volume is less than 70 μL, an increase in “Air in Sample” errors
may result. Sample volumes should never exceed 150 μL. Volumes greater than 150 μL will result in the
sample mixing with the Calibrant B in the inlet tube.
The required minimum volume for a diluted urine sample is two 70 μL dispenses (one after the
<UWBW> command, and one after the <UNBW> command). If the sample volume is less than 70 μL,
an increase in “Air in Sample” errors may result. Sample volumes should never exceed 150 μL. Volumes
greater than 150 μL will result in the sample mixing with the Calibrant B sample in the inlet tube.
There are many ways to determine if the host analyzer is inadvertently diluting samples. One way is to
put a dye into the wash solution, and then aspirate and dispense samples. If dye colors the sample, it
has been diluted with wash solution. Another method is to measure a sample using a manual dispense
(pipette a 70 μL sample into the sample entry port) and compare the results to samples dispensed by the
host analyzer into the sample entry port.
Contact Medica’s Technical Service Department for further details or advice on optimizing sample
aspiration and dispensing.

Performance Evaluation
Medica suggests a series of test protocols to evaluate the integration of the ISE Module into the host
analyzer. Medica strongly recommends performing carryover, precision, linearity, and comparison of
methods evaluation.
It is very useful if these protocols are run on the ISE Module as a stand-alone unit and as integrated into
the host analyzer.
Performing the protocols on the ISE Module as a stand-alone unit allows for a good understanding of
the baseline performance of the ISE Module. It can then be directly compared with data generated at
Medica. Performing the protocols on the ISE Module after integration is required to meet regulatory
requirements (such as U.S. FDA 510 (K)). Having data from both the stand-alone unit and integrated
unit will also allow more effective troubleshooting after integration.
The carryover evaluation is typically performed by running a series of triplicate high and triplicate low
samples repeatedly and comparing the first value to the average of the second two samples. There is a
standard protocol for this type of testing: CLS1 Document EP07-A (or the latest revision)—Interference
Testing in Clinical Chemistry.

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 o s y s t e m i n t e g r a t i o n n o t e s

Precision evaluation is typically performed by running a series of sample pools multiple times per day for
several days to evaluate the reproducibility of each analyte for within run, run-to-run, day-to-day, and
total precision. It is very important that the sample pools be handled properly to ensure their integrity and
stability over the course of the study. There is a standard protocol for this type of testing: CLS1 Document
EP05-A2 (or the latest revision)—Evaluation of Precision Performance of Quantitative Measurement
Methods.
Linearity evaluation is typically performed by running a series of sample pools which have the values
adjusted across the claimed operating range for each analyte. The value assignment of these pools will
play a very important role in the evaluation, and should be carefully considered. There is a standard
protocol for this type of testing: CLS1 Document EP6-A (or the latest revision)—Evaluation of the Linearity
of Quantitative Measurement Procedures: A Statistical Approach.
Comparison of methods evaluation is typically performed by running a series of patient samples on
the test system and on a reference system (for each analyte) over the course of several days. This
test evaluates how the system compares to a reference system. Care must be taken to select properly
functioning reference analyzers. Different reference analyzers will give different results. Medica’s ISE
Module has been designed to give results that correlate with Medica’s EasyElectrolytes analyzer. There
is a standard protocol for this type of testing: CLS1 Document EP09-A (or the latest revision)—Method
Comparison and Bias Estimation Using Patient Samples.
It is very important to properly evaluate the ISE Module after it has been integrated into your host
analyzer. The above protocols for this testing are well defined. Medica strongly recommends that these
protocols be used before and after you complete your integration to ensure that the ISE Module functions
properly.
If you have any questions or problems running any of these protocols, contact Medica’s Technical Service
for more details or advice on how to perform these important tests.

Matrix Effects
Sample Matrix. The ISE Module is designed to analyze human serum, plasma, and diluted urine.
Surfactants. Virtually all surfactants can irreversibly harm ISE electrodes.
Most oils, emulsions, many organic chemicals, as well as certain inorganic chemicals and buffers, can
also harm the electrodes (sometimes irreversibly).
QC Materials. Caution must be exercised when selecting quality control materials. QC materials
specifically designed for use with ion-selective electrodes usually perform suitably, but Medica can only
guarantee that QC materials it has validated are compatible with its electrodes. Medica recommends
its EasyQC quality control material for use with the ISE Module. QC materials should be run after each
calibration to ensure the integrity of sample results.

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 s y s t e m i n t e g r a t i o n n o t e s n

Sample Handling and Collection

For complete sample handling and storage information, the user should refer to the CLSI Standard
C46A2--Blood Gas and pH Analysis and Related Measurements.
BIOHAZARD: Human body fluid specimens may be contaminated with HIV or other pathogens.
Treat all specimens and collection devices and equipment as biohazardous materials.
Vacuum Collection Tubes
Serum
1C
 ollect the specimen by venipuncture into an untreated tube. Fill the tube to at least 2/3 of the
total volume. Note the time of collection.
2 Let blood stand for 20–30 minutes to allow clot formation.
3 Centrifuge the tube for 10–15 minutes and remove the serum to a clean specimen tube.
4S
 erum may be analyzed immediately, stored at 4°C for 24 hours, or frozen at -20°C for up to
one week. Samples must be brought to room temperature and mixed well before assaying.
To obtain accurate results, samples should be free of any clots, fibrin, etc., which would obstruct
sample flow and affect results. The use of a serum clearing agent is strongly recommended.
If a serum separator tube is utilized, care must be taken to avoid inserting the sample probe into the
gel layer. This can create obstructions in the sample probe and the fluid path.
Plasma
Plasma samples offer an advantage over whole blood specimens when short term storage is a
factor. If the sample is to be stored, serum specimens are preferable.
1C
 ollect the specimen by venipuncture into a Sodium-Heparin evacuated blood collection tube. The
heparin level should not exceed 15 IU per mL of tube volume. Note the time of collection. DO
NOT USE AMMONIUM HEPARIN, LITHIUM HEPARIN, EDTA, OR NaF TUBES.
2 Mix the specimen by inverting the tube. Do not shake.
3C
 entrifuge the specimen within one hour of collection. Carefully remove the top plasma layer for
analysis. Use a Pasteur pipette or a syringe fitted with a blunt tipped needle for this procedure.
4A
 nalyze plasma samples within 4 hours of collection. Refrigerated samples must be brought to
room temperature and centrifuged prior to analysis.
When using Sodium-Heparin collection tubes, collect a full tube of specimen to minimize the effect of
sodium heparin on the ISE Module sodium measurement.

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 o s y s t e m i n t e g r a t i o n n o t e s

Urine Samples
Sample Size and Dilution
The required minimum sample volume for a urine sample diluted (1 part urine and 9 parts diluent)
with urine diluent is 140 μL (2 x 70 μL), two 70 μL dispensings.
Warning: Significant carryover into the subsequent serum sample will occur if a urine sample is
inadvertently analyzed in an undiluted form. Potassium errors may exceed 1 mmol/L. Results are
multiplied by 10, so the reported results will be multiplied by ten.
Never dispense a volume greater than 150 μL because it may come in direct contact with the
Calibrant B port on the side of the sample entry port. Contamination of subsequent samples and
Calibrant B will result.

Operating Cycles
Calibration Cycle <CALB>
This cycle is used to calibrate the electrodes of the ISE Module. Calibration is initiated when the
host analyzer sends the command <CALB>. The ISE Module then cycles Calibrant B and Calibrant
A solutions in front of the electrodes and measures the millivolt output of the electrodes for each of
the respective solutions.
These millivolt readings are then used to set up a relationship between sample concentration and
electrode millivolt output. The change in millivolts per change in concentration is the slope of
the electrode. The slope of the electrodes is reported in mv/dec (millivolts per decade change in
concentration), and should be within the following limits:
Li+ 47-64 mV/dec
Na+ 52-64 mV/dec
K+ 52-64 mV/dec
Cl- 40-55 mV/dec
The ISE Module Calibration Cycle performs two successive calibrations. The slopes should be
repeatable within 1.5 mV/decade change; if not, repeat the <CALB> command. The calibration
frequency should be once every 8 hours. A calibration should be performed after each Clean
Cycle, or if the QC sample results do not repeatedly fall within the proper ranges. The host
analyzer should flag ISE results after the 8-hour interval is exceeded. Additionally, QC materials
should be run after each calibration to ensure the accuracy of sample results.
The details of the Calibration Cycle are as follows:
The host analyzer sends the command <CALB>. The ISE Module then clears the electrode flow path
of Calibrant A (note that in between cycles, Calibrant A remains in front of the electrodes). Next,
the ISE Module rinses the flow path with 100 μL of Calibrant B. The ISE Module then dispenses 80
μL Calibrant B into the sample entry port, and then slowly positions it in front of the electrodes.
There is a 9 second pause, and the mV reading takes place. The ISE Module then clears the
electrode flow path of Calibrant B. Next, the ISE Module rinses the flow path with 100 μL of
Calibrant A. The ISE Module dispenses 80 μL Calibrant A into the sample entry port, and then
slowly positions it in front of the electrodes. There is a 9 second pause, and the mV reading takes
place. The ISE Module can now calculate the slopes of the electrodes. This cycle is then repeated.

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 s y s t e m i n t e g r a t i o n n o t e s n

Each <CALB> command will result in two Calibration Cycles and uses an approximate total of 360
μL of Calibrant A and 360 μL of Calibrant B.
Refer to Cycle Diagrams.

Serum Cycle <SAMP>

This cycle is used to measure serum or plasma samples on the ISE Module. A
Serum Cycle is initiated when the host analyzer sends the command <SAMP>.
The ISE Module then positions the serum or plasma sample and Calibrant A in front of the
electrodes and measures the millivolt output of the electrodes for both the serum or plasma sample
and Calibrant A.
The millivolt values obtained for the sample and for Calibrant A are used with the slope (determined
in the Calibration Cycle) to ascertain the value in mmol/L of the specimen.
The details of the Serum Cycle are as follows:
The host analyzer sends the command <SAMP>. The ISE Module then clears the electrode flow
path of Calibrant A (note that in between cycles, Calibrant A remains in front of the electrodes).
Next, the ISE Module returns the <ISE!> message indicating that the Module is ready to receive the
sample. The host analyzer should then dispense 70 μL of sample into the sample entry port. Once
this step is completed by the host analyzer, the host analyzer should send the <STRT> command.
The ISE Module then slowly positions the sample in front of the electrodes. There is a 9 second
pause, before the mV reading takes place.
The ISE Module then clears the electrode flow path of the sample. Next, the ISE Module rinses the
flow path with 100 μL of Calibrant A. The ISE Module dispenses 80 μL Calibrant A into the sample
entry port, and then slowly positions it in front of the electrodes. There is a 9 second pause, and the
mV reading takes place. The ISE Module can now calculate the sample results in mmol/L.
Each <SAMP> command will result in approximately 180 μL of Calibrant A being used.
Refer to Cycle Diagrams.

Urine Cycle <UWBW> and <UNBW>

This cycle is used to measure diluted urine samples on the ISE Module. A Urine Cycle is initiated
when the host analyzer sends the command <UWBW>. The ISE Module then positions the urine
sample and Calibrant B in front of the electrodes, and measures the millivolt output of the electrodes
for both the sample and Calibrant B.
The millivolt values obtained for the urine sample and for Calibrant B are used with the slope
(determined in the Calibration Cycle) to ascertain the value in mmol/L of the sample. The details of
the Urine Cycle are as follows:
The host analyzer sends the command <UWBW>. The ISE Module then clears the electrode flow
path of Calibrant A (note that in between cycles, Calibrant A remains in front of the electrodes).
The ISE Module rinses the flow path with 50 μL of Calibrant B. Next, the ISE Module returns the
<ISE!> message indicating that the ISE Module is ready to receive the sample. The host analyzer
should then dispense 70 μL of a diluted urine specimen (which has been diluted 1 part urine plus 9
parts urine diluent) into the sample entry port. Once this step is completed, the host analyzer sends
the <UNBW> command. The Module then positions the urine in front of the electrodes and returns
the <ISE!> message indicating that the ISE Module is ready to receive the second urine sample.
The host analyzer should then dispense another 70 μL of the diluted urine sample (which has been

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 o s y s t e m i n t e g r a t i o n n o t e s

diluted 1 part urine plus 9 parts urine diluent) into the sample entry port. Once this step is completed by
the host analyzer, the host analyzer should then send the <STRT> command. The ISE Module then slowly
positions the diluted sample in front of the electrodes. There is a 9 second pause, and the mV reading
takes place.
The ISE Module then clears the electrode flow path of the diluted sample. Next, the ISE Module rinses the
flow path with 100 μL of Calibrant B. The ISE Module then dispenses 80 μL Calibrant B into the sample
entry port, and then slowly positions it in front of the electrodes. There is a 9 second pause, and the mV
reading takes place. The ISE Module calculates the sample results in mmol/L. Then the ISE Module rinses
the flow path with 100 μL of Calibrant A. Each <UWBW> command will result in approximately 50 μL
of Calibrant B being used. Each <UNBW> command will result in 200 μL of Calibrant A and 200 μL of
Calibrant B being used.
Refer to Cycle Diagrams.

Clean Cycle <CLEN>

This cycle is used to remove protein build-up from the ISE Module electrodes. The Clean Cycle is initiated
when the host analyzer sends the <CLEN> command. The ISE Module positions cleaning solution in front
of the electrodes for a period of time which will allow the enzyme to remove protein build-up on the
electrodes. Once this is done, the ISE Module is then flushed with Calibrant A.
The Clean Cycle should be performed once per 24-hour period. Medica strongly recommends that a
Calibration Cycle be run after a Clean Cycle. Medica also recommends that the Clean Cycle be run at
the end of the day to give the electrodes extra time to stabilize after the Clean Cycle. This is not required.
However, users will experience slightly better performance if they give the electrodes some time to
stabilize after the Clean Cycle. It is also recommended that high volume users run a Clean Cycle after
every 50 serum samples.
The details of the Clean Cycle are as follows:
The Host Analyzer sends the command <CLEN>. The ISE Module then clears the electrode flow path of
Calibrant A (between cycles, Calibrant A remains in front of the electrodes). Next, the Module returns the
<ISE!> message indicating that the ISE Module is ready to receive the cleaning solution. The host analyzer
should then dispense 100 μL of cleaning solution into the sample entry port. Once this step is completed
by the host analyzer, the host analyzer should send the <STRT> command.
The ISE Module then slowly positions the cleaning solution in front of the electrodes. There is a
105-second pause while the cleaning takes place. The ISE Module then clears the electrode flow path of
the cleaning solution, and rinses the flow path with 100 μL of Calibrant A. The ISE Module then dispenses
80 μL Calibrant A into the sample entry port and slowly positions it in front of the electrodes. The ISE
Module should now be recalibrated using the Calibration Cycle. The ISE Module indicates the cycle is
complete by transmitting <ISE!>.
Each <CLEN> command will result in approximately 180 μL of Calibrant A being used and requires 100
μL of cleaning solution. Refer to Cycle Diagrams.

Purge A Cycle <PUGA>

This cycle is used to purge Calibrant A solution through the tubing from the reagent pack to the ISE
Module. The purge cycle is initiated when the host analyzer sends the command <PUGA>. The ISE
Module pumps Calibrant A from the reagent pack through the ISE Module to wash out the flow path.
The details of the Purge A Cycle are as follows: The host analyzer sends the command <PUGA>. The ISE

40
 s y s t e m i n t e g r a t i o n n o t e s n

Module then clears the electrode flow path of Calibrant A (note that between cycles, Calibrant A remains in front
of the electrodes). The ISE Module then pulls 100 μL of Calibrant A from the reagent pack and dispenses it into
the sample entry port.
The ISE Module then positions the Calibrant A in front of the electrodes.
Each <PUGA> command will result in 100 μL of Calibrant A being used.
Refer to Cycle Diagrams.

Purge B Cycle <PUGB>

This cycle is used to purge Calibrant B solution through the tubing from the reagent pack to the ISE Module. The
Purge Cycle is initiated when the host analyzer sends the command <PUGB>. The ISE Module pumps Calibrant B
through the ISE Module to wash out the flow path.
The details of the Purge B Cycle are as follows:
The host analyzer sends the command <PUGB>. The ISE Module then clears the electrode flow path of Calibrant
A (note that between cycles, Calibrant A remains in front of the electrodes). The ISE Module then pulls 100 μL
of Calibrant B from the reagent pack and dispenses 100 μL of Calibrant B into the sample entry port. The ISE
Module then positions the Calibrant B in front of the electrodes.
Each <PUGB> command will result in 100 μL of Calibrant B being used.
Refer to Cycle Diagrams.

Sip Cycle
Every 30 minutes after the last sample is run, the ISE Module will automatically run a Sip Cycle. The Sip Cycle
is used to keep the calibrants in the tubing fresh, and to refresh the Calibrant A in front of the electrodes. In the
Debug Cycle, millivolt data will be reported for each electrode. If desired, this data can be used to monitor the
electrode status.
No command is required from the host analyzer to initiate a Sip Cycle. The ISE Module automatically clears the
flow path, next the ISE Module dispenses 36 μL of Calibrant B into the Sample Entry Port, and it pulls it past the
electrodes using the waste pump. The ISE Module then dispenses 95 μL of Calibrant A into the sample entry port,
and positions it in front of the electrodes. There is a 9-second pause, and the mV reading takes place.
In certain rare cases, the concentration of Calibrant A or Calibrant B could change in the tubing between the
Reagent Pack and the ISE Module due to evaporation. If a user performs at least one serum or plasma sample
(<SAMP>) every 30 minutes or less, the sip cycle will not be initiated, and the Calibrant B will not be refreshed
(with each <SAMP> cycle, 200 μL of Calibrant A will be used, however no Cal B will be used). After some time,
the Calibrant B will evaporate and a subsequent calibration or urine sample could be affected.
Therefore, in the rare case specified above (at least one <SAMP> cycle every 30 minutes for more than 2 hours,
and no urine cycles), Medica strongly urges the host analyzer run a <PUGB> cycle every 30 minutes followed by
a <PUGA>.
Likewise the host analyzer should run a <PUGA> cycle every 30 minutes in the rare case of consistent usage of
<UWBW>, <UNBW> cycles (at least one urine cycle every 30 minutes for more than 2 hours, and no <SAMP>
cycles). These extra cycles should not be required during periods of inactivity since the ISE Module will perform a
sip cycle every 30 minutes after the last sample.

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 o s y s t e m i n t e g r a t i o n n o t e s

Maintenance Cycle <MANT>

This cycle is used to clear fluid from the flow path of the ISE Module, and to pause the Sip Cycle. The
Maintenance Cycle is initiated when the host analyzer sends the command <MANT>. The ISE Module then
runs the waste pump until the electrode flow path is cleared of fluid.
Warning: This cycle is required before any electrode(s) is removed from the ISE Module. Failing to
run this cycle will cause the fluid in the flow path to leak when electrodes are removed. Spilled fluid (or
electrodes that are wet on the outside) can cause sporadic and/or erroneous results. Always dry each
electrode when changing electrodes.
It should be noted that every 30 minutes, a Sip Cycle is initiated, and 100 μL of Calibrant A is dispensed.
If the electrodes are removed without initiating a Maintenance Cycle, a Sip Cycle may occur and the 100
μL of Calibrant A will flow into the empty module. This can cause significant damage to the ISE Module
and/or other surrounding components.
Never leave the Module in this status with the reference electrode in place for more than an hour after a
Maintenance Cycle is initiated, as KCl will diffuse out of the reference electrode. Over time, the KCl will
clog the flow path. As soon as the electrodes are reinstalled, run a <PUGA>, <PUGB> or <CALB>.
The details of the Maintenance Cycle are as follows:
The host analyzer sends the command <MANT>. The ISE Module clears the electrode flow path of
Calibrant A (note that in between cycles, Calibrant A remains in front of the electrodes). When completed,
the Module returns the <ISE!> message, indicating that the ISE Module is in the maintenance mode, and
the Sip Cycle has been suspended. Electrodes can be safely removed after completion of the Maintenance
Cycle. Refer to Cycle Diagrams.

Pump Calibration Cycle <PMCL>

This cycle is used to calibrate the peristaltic pumps of the ISE Module. Pump Calibration is initiated when
the host analyzer sends the command <PMCL>.
The host analyzer dispenses 100 μL of Calibrant B into the Module, and the ISE Module then counts the
number of steps required for the Waste Pump to move the 100 μL of Calibrant B past the bubble detector.
The ISE Module then cycles Calibrant A and Calibrant B solutions in front of the bubble detector and
measures the number of steps required to move the Calibrant A and Calibrant B past the bubble detector.
The number of steps required to move the initial 100 μL of Calibrant B is used to set up a relationship
between sample volume and Waste Pump motor steps. This value is subsequently used to calibrate the
volume dispensed by the Calibrant A and Calibrant B pumps. This calibration process ensures that the
proper volumes of Calibrant A and Calibrant B are dispensed during subsequent calibrations, sample,
and urine cycles.
Medica recommends performing a Pump Calibration Cycle once per day. The Pump Calibration values of
A and B should be within the range 1500 to 3000.
The details of the Pump Calibration Cycle are as follows: The host analyzer sends the <PMCL> command.
The ISE Module then clears the electrode flow path of Calibrant A (note that in between cycles, Calibrant
A remains in front of the electrodes). When completed, the ISE Module returns the <ISE!> message
indicating that the ISE Module is ready. The host analyzer should then accurately dispense 100 μL of
Calibrant B into the sample entry port, after which it should send the <STRT> command (Refer to Dispense
Cal B section for a source of Cal B).
The ISE Module then counts the number of steps required for the waste pump to move the entire 100 μL of
Calibrant B past the bubble detector. The ISE Module can now calculate the relationship between volume
and waste pump counts.

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 s y s t e m i n t e g r a t i o n n o t e s n

The ISE Module then dispenses approximately 100 μL of Calibrant A into the sample entry port by
running the Calibrant A pump a certain number of steps, based on the calculations above. The ISE
Module then moves the Calibrant A from the sample entry port by turning the waste pump until the
bubble detector sees both ends of the sample. The ISE Module can now calculate the exact volume
dispensed into the sample entry port. It does this by using the number of steps the waste pump turns
in combination with the relationship established above. This process is repeated for the Calibrant B
pump.
Each <PMCL> command will result in 175 μL of Calibrant A, and 375 μL of Calibrant B to be used.
Additional volumes of Calibrant A and Calibrant B are due to wash cycles.
Refer to Cycle Diagrams.

Debug <DVON>, or <MVON>

These commands are used to turn millivolts on. The Debug routine is initiated when the host analyzer
issues either the <DVON> or the <MVON> command. Whenever the <DVON> command is used,
the ISE Module will report the millivolt data for all the electrodes for Sample Cycles, Calibration
Cycles, and Sip Cycles. Whenever the <MVON> command is used, the ISE Module will report the
millivolt data for all the electrodes for Sample Cycles and Calibration Cycles, but not for Sip Cycles.
Medica recommends using the Debug command whenever troubleshooting the ISE Module. The
Debug mode allows better diagnostics to be performed by printing out the millivolt data for Calibrant
B and Calibrant A during Calibration Cycles, Sample and Calibrant A millivolts during sample
cycles, and Calibrant A data during the sip cycle. Large changes in the Calibrant A mV results
indicate a problem with that part of the cycle, while large changes in the sample millivolts (for the
same sample) indicate a problem with that part of the cycle.
Note that for a Calibration Cycle, the data string with BMV includes the millivolt data for Calibrant
B, the data string with AMV includes the millivolt data for Calibrant A, and the data string with CAL
includes the slope data in millivolts per decade change in concentration.
For a Sample Cycle, the data string with SMV includes the millivolt data for the sample, the data
string with AMV includes the millivolt data for Calibrant A, and the data string with SER includes the
sample results in mmol/L.
For a Urine Cycle, the data string with UMV includes the millivolt data for the urine sample, the data
string with BMV includes the millivolt data for Calibrant B, and the data string with URN includes the
urine sample results in mmol/L.
Debug <DVFF>
This command is used to turn millivolts off. The Debug routine is terminated when the host analyzer
issues the <DVFF> command.

Dispense Cal A <DSPA_XXX>

This cycle is used to dispense a volume (XXX μL) of Calibrant A into the sample entry port. The
dispense is initiated when the host analyzer sends the command <DSPA_XXX>. The module then
dispenses XXX μL of Calibrant A into the sample entry port.
This cycle is useful when performing a Sample Cycle <SAMP>. To reduce the sample size, aspirating
a small amount of Cal A prior to aspirating the sample can reduce carryover. Since Cal A is close to
a normal sample concentration, it should reduce dilution with the host analyzer diluent.
The sequence would be: The host analyzer sends the command <DSPA_150>.

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 o s y s t e m i n t e g r a t i o n n o t e s

The ISE Module dispenses 150 μL of Calibrant A into the sample entry port.
The host analyzer aspirates a small amount of Calibrant A into the sample probe from the sample
entry port. The host analyzer sends the <SAMP> command, and picks up a combination of air
segments and small volumes of sample (as described in the Sample Aspirating and Dispensing
section of the Applications Manual). The host analyzer then dispenses the 70 μL sample into the
sample entry port, and sends the <STRT> command.

Dispense Cal B <DISB_XXX>

This cycle is used to dispense a volume (XXX μL) of Calibrant B into the sample entry port. The
dispense is initiated when the host analyzer sends the command <DISB_XXX>. The module then
dispenses XXX μL of Calibrant B into the sample entry port.
This cycle is useful when performing a Pump Cal <PMCL>. In order to perform a pump cal, the
host aanalyzer must dispense 100 μL of Calibrant B into the sample entry port. Using the Dispense
Calibrant B cycle, the host analyzer has a source of Calibrant B available to it.
The sequence would be: The host analyzer sends the command <DISB_150>. The ISE Module
dispenses 150 μL of Calibrant B into the sample entry port. The host analyzer aspirates 100 μL of
Calibrant B from the sample entry port. The host analyzer sends the <PMCL> command. The ISE
Module clears the sample entry port and the flow path of Calibrant B. The host analyzer dispenses
100 μL of Calibrant B into the sample entry port. The host analyzer sends the <STRT> command.
The ISE Module calibrates all 3 peristaltic pumps (per the Pump Calibration Cycle).

Bubble Cal Cycle <BBCL>

The Bubble Cal command is used to allow the module to reestablish a baseline for detecting air-
liquid interfaces. It can also be used as a diagnostic tool to see if the bubble detector is functioning
properly. Bubble Cal is initiated when the host analyzer issues the <BBCL> command. The ISE
Module cycles Calibrant A in front of the bubble detector and reads the difference in counts
between air and Calibrant A, then reports the result in the form <BBC A xxx M xxx L xxx>. The
delta between the A and L values should be greater than 90 counts. Each <BBCL> command will
result in 75 μL of Calibrant A to be used.

Prime A Cycle <PRMA>

This cycle is used to prime Calibrant A solution from the reagent pack. The prime cycle is initiated
when the host analyzer sends the command <PRMA>. It is the same as <PUGA> except is uses 240
μL instead of 100 μL.

Prime B Cycle <PRMB>

This cycle is used to prime Calibrant B solution from the reagent pack. The prime cycle is initiated
when the host analyzer sends the command <PRMB>. It is the same as <PUGB> except is uses 240
μL instead of 100 μL. Last Result <SWLR>
The last result command is used to recall the last result. The last result (sample or urine) will be
resent by the ISE Module when the host analyzer sends the <SWLR> command.

Last Result <SWLR>

The last result command is used to recall the last result. The last result (sample or urine) will be
resent by the ISE Module when the host analyzer sends the <SWLR> command.

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Cycle Charts
Note
Actual cycle times may vary due to variations in pump tubing, pump calibrations, and
overall flow performance. These cycle times represent optimal cycle times. Refer to the
product specifications for maximum cycle times.

Calibration Cycle <31–40> seconds

<CALB> Repeat

4.3 s 3.1 s 9s 1s 4.3 s 3.1 s 9s 1s

Empty/Rinse Dispense/Position Wait Read Empty/Rinse Dispense/Position Wait Read
0.5 s
Calculations
Result

Serum Cycle <28–33> 30 seconds

<SAMP> <STRT>

<1.5–2.0>s 2.2 s 9s 1s 4.3 s 3s 9s 1s

Empty Position Wait Read Empty/Rinse Dispense and Wait Read
Position 0.5 s
Calculations
Module Waits for Host to Dispense Sample Result

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 o s y s t e m i n t e g r a t i o n n o t e s

Urine Cycle
<4.4–5.5> seconds

<UWBW> <ISE!>
2.3 s 1s
Empty Empty
2.2 s
Position

<34.5–43.5> seconds

<UNBW> <STRT>
<1.5–2.0> s 2.2 s 9s 1s 4.3 s 3.1 s 9s 1s 4.2 s
Empty Position Wait Read Empty/Rinse Dispense and Wait Read Empty/Rinse
Position 0.5 s
Calculations
Module Waits for Host to Dispense Sample Result

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 s y s t e m i n t e g r a t i o n n o t e s n

Pump Cal <25–26> seconds

Cycle

<PMCL> <STRT>

<1.5–2.0> s 3.5 s 2.55 s 3.5 s 2.55 s 3.5 s

Empty Position w/ Empty/Rinse Position Empty/Rinse Position
Waste Pump 1.5 s Cal B 1.5 s Cal A 0.1 s
Dispense w/Waste Dispense w/Waste Calculations
Cal B Pump Cal A Pump Result
Module Waits for Host to Dispense Cal A

Clean Cycle <125–132> seconds

<CLEN> <STRT>

<1.5–2.0> s 2.2 s 105 s 5.25 s 3s

Empty Position Wait Empty/Rinse Dispense and
Position

Module Waits for Host to Dispense Cleaning Solution

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 o s y s t e m i n t e g r a t i o n n o t e s

Purge A/Purge B Cycle

<4.3–8.5> seconds

<PUGA>/
<PUGB> 1.3 s 2.9 s
Empty Position
1.2 s
Dispense

<4.5–12.8> seconds

<PRMA>/
<PRMB> 1.3 s 3.0 s
Empty Position
3.0 s
Dispense

Maintenance Cycle

<MANT>
<1.5–2.0> seconds
Empty

48
Maintenance

Maintenance Schedule
The ISE Module has been designed to require very little operator maintenance. The only daily
maintenance required is to run the cleaning solution after the last sample of the day or after 50 patient
samples, whichever is first. Clean the sample inlet port with a cotton swab and DI water once per month.
All other parts and expendables are replacement items (see schedule below). Use only Medica approved
components.

Recommended Component Replacement Schedule (low volume user)

Li+ Electrode 6 months
Pump Tubing 6 months
Na+ Electrode 6 months
K+ Electrode 6 months
Cl- Electrode 6 months
Reference Electrode 6 months
Fluidic Tubing 12 months

Recommended Component Replacement Schedule (high volume user, greater than

100 samples/day)
Li+ Electrode 3,000 samples
Pump Tubing 6 months
Na+ Electrode 10,000 samples
K+ Electrode 10,000 samples
Cl- Electrode 10,000 samples
Reference Electrode 10,000 samples
Fluidic Tubing 12 months

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 r m a i n t e n a n c e

Shutdown Procedure: Preparing the ISE Module for Storage

Shutdown Procedure: Preparing the ISE Module for Storage
If the laboratory plans to store the ISE Module, the following steps should be performed:
Before removing the electrodes, they should be cleaned using the cleaning solution and then 3 <PUGA>
cycles should be run. Enter the Maintenance Cycle of the analyzer (host analyzer requests <MANT>) to
purge the ISE Module fluid path.
Reference, Na+, Cl- electrodes
•D
 epress the compression plate and remove all electrodes, including the reference electrode from the
ISE Module.
• Place the Na+ and Cl- electrodes into individual sealed bags.
•R
 einsert the Reference Electrode flow path line with yellow flag, if available, and then put into
individual sealed bags.
K+ and Li+ electrodes
•A
 spirate a small volume of Calibrant A from the top port of the reagent pack into a syringe fitted with
a blunt needle.
• Inject sufficient Calibrant A into the lumen of the K+ and Li+ electrodes until fluid fills the lumen.
 over both ends of the lumen (both sides of the K+ and Li+ electrodes) with tape to hold the Calibrant
•C
A in place.
• Insert the K+ and Li+ electrodes into a sealed bag.
Reagent Pack
• Remove the reagent pack from the analyzer and discard.
Analyzer Tubing
• Remove all fluidic tubing and thoroughly rinse with DI water.
ISE Module re-activation
• Remove all electrodes from sealed bags.
• Remove tape from K+ and Li+ electrode.
• If necessary, soak the reference electrode in warm water until the lumen of the electrode has been
cleared of salt build-up.
• Install electrodes into the ISE Module.
• Connect new reagent pack to the ISE Module.
• Use Prime Cycles to prime the calibrants.
• Calibrate analyzer.

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Troubleshooting

Overview
To enhance trouble-free operation of the ISE Module, it is important to follow the recommended
component replacement schedule listed in the maintenance section of this manual.
When the ISE Module is not operating properly, approach troubleshooting as a logical sequence of
events. Isolate the problem area to avoid unnecessary component replacement and down time.
Troubleshooting can be categorized into three main areas. These areas are: fluid delivery,
electrode stability, and communication. Once your chemistry system is developed to a point that the
communication is stable and the data transmission is properly interpreted, troubleshooting should focus
primarily on fluid delivery and electrode stability. As these are related, sometimes the same symptoms
can have different causes.
Most problems can be corrected while the ISE Module is still installed in your chemistry system.
However, if you experience a particularly difficult problem, it may be necessary to remove the ISE
Module and test it using the ISE Module Demo Kit connected directly to a computer.

Communication Errors
System Does Not Respond
1. Make sure that power is reaching the ISE Module.
•W
 ith the power turned on, you should be able to read 24VDC between T1 and T2 on the Interface
Cable Assembly.
•Y
 ou should also be able to read 24VDC between pins 27 and 29, or 28 and 30 on the main
connector where the Interface Cable Assembly is connected to the ISE Module main PCD.
2. Turn off power to the ISE Module and re-apply the power.
3. Check the RS232 cable for damage. Replace the Interface Cable Assembly, if necessary.
4. R
 emove the ISE Module and operate using the Demo Kit connected directly to the computer. Follow
the Quick Start Guide at the beginning of this manual for proper communication protocols and
procedures. If the ISE Module works properly, then the problem is either with the Interface Cable
Assembly in your chemistry system, or there is a problem in the chemistry system itself.
5. If the ISE Module does not communicate on the Demo Kit, replace the Main PCB.

Fluid Delivery
It is necessary to perform a Pump Calibration cycle each day. This cycle will calibrate the pumps that
dispense Cal A and Cal B, and position fluid in front of the electrodes. The waste pump moves solution
from the Sample Entry port to the electrode area for measurement. As the tubing ages and samples are
passed through the system, the positioning of the solution will change. The pump uses a stepper motor
that counts how many steps it takes to move the solution to the correct position.
By calibrating the pump each day, the ISE Module can now calculate the relationship between volume
and pump steps. This will enable the pumps to dispense an accurate volume of calibrant, and for the
solution to be accurately placed in the proper location for analysis. Problems can be caused by a
partial obstruction from a clot in the tubing from the exit tube to the waste pump, a sharp bend in the

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 o t r o u b l e s h o o t i n g

waste tubing that restricts the flow, a misalignment of the electrodes, or from too great a length of tubing
from the exit tube to the waste pump. As the pump tries to pull the fluid from the sample entry port into
the electrodes, a vacuum develops because of the restriction. The bubble detector detects the trailing
edge of the solution (sample, calibrant, etc.) and stops the waste pump so that the solution is in front of
the electrodes. The vacuum will cause the solution to travel after the pump stops.
One of the first indications of a flow problem will be the lithium electrode response.
If, however, the solution slowly moves out of the electrodes when the pump has not been activated,
there is either a leak between the electrodes, or along the flow path. This can be tested by placing
solution into the sample entry port by hand and watch to see if the fluid level changes. In either case,
the symptoms would be similar—the lithium or sodium millivolts would experience noise errors and the
bubble detector would trigger an error.
Electrode Stability
Errors associated with electrode instability typically include drift, noise, and slope failures. While
these errors may be caused by a failure of a particular electrode, it is necessary to explore other
causes as well. Proper operation on a daily basis is the key to keeping the electrodes stable and the
system working properly. Each day, it is necessary to perform a Cleaning Cycle. The cleaning solution
removes protein build-up in the flow paths of both the electrodes and the tubing. In high sample volume
instances, it may be necessary to perform this cycle more than once in a single day.
It is also necessary to replace the Reference Electrode every six months or when the red ball indicator
no longer floats in the internal electrode solution, whichever comes first. Failure to replace the Reference
Electrode at this interval will cause all three of the errors mentioned.
Ensure that the ISE Module is properly gounded. This is described in detail in the System Integration
Notes section of this manual.

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 t r o u b l e s h o o t i n g w

Troubleshooting Guide
Symptom Problem Correction

System does not respond 1. No power.

2. Communication failure. Turn off power, reapply
power.
3. RS232 cable is disconnected Reconnect or replace cable.
or damaged.
4. ISE Module connector has Replace board.
been damaged.
5. Component failure on board. Replace board.

Low Slope Na+ or K+ 1. Misalignment of electrodes. Remove electrodes.

<52 mV/decade Inspect o-rings. Reassemble
Cl- <40mV/decade, Li+<47mV properly.
mV/decade or High Slope Na+, 2. Calibrator solutions. Replace Reagent Pack.
K+, or Li+>64 mV/decade 3. Electrode (low slope). Replace electrodes.
Cl- >55 mV/decade 4. Air bubble on reference Remove electrode, tap to dislodge
electrode membrane. bubble, replace, and recalibrate.
5. Reference electrode. Replace reference electrode and retest.
6. ISE Module or fluid Change ISE Module location
temperatures exceed if ambient temperature is
32° C. (high slope). too great.

Noise Error Flag 1. Electrode. Replace problem electrode

Single electrode and recalibrate.
2. Electrical noise spike from a) Find source of spike and
environmental source. eliminate.
b) Check grounding of ISE Module.
3. Component failure on Replace board.
ISE Module board.
4. Salt or liquid contamination. Remove electrode, clean all surfaces with
damp paper towel, dry, reassemble.

Noise Error Flag 1. Reference electrode. Replace reference electrode and

Multiple electrodes recalibrate.
2. Electrical noise spike from a) Check for electrical noise
environmental source. coincident with activation.
b) Check grounding of ISE Module
3. Component failure on Replace board.
ISE Module board.
4. Salt or liquid contamination. Remove electrode, clean all surfaces with
damp paper towel, dry, reassemble.

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 o t r o u b l e s h o o t i n g

Symptom Problem Correction

Drift Error Flag 1. May occur when new electrode Purge the Calibrant A and
Single electrode or Calibrant A is installed. recalibrate the ISE Module.
If the electrode is new it may
initially drift as it rehydrates
over the course of 15 minutes.
2. Electrode. Replace the electrode and
recalibrate.

Drift Error Flag 1. May occur when new Purge Calibrant A and
Multiple electrodes electrode or Reagent Pack recalibrate.
is installed on system.
2. Reference electrode. Replace reference electrode
and recalibrate.
3. Electrical spike from a) Find source of spike and
environmental source. eliminate.
b) check grounding of ISE
Module.
4. Component failure on Replace the board.
ISE Module board.

Air in Sample 1. Insufficient sample pipetted a) Host instrument must deliver

into ISE Module sample 70 μL. Increase dispensed
entry port. sample volume.
2. Bubbles in Sample Host must deliver sample free
of bubbles.
3. Fluid leaks Determine source of leak
and resolve.
4. Sample not positioned. a) Electrodes not seated
properly. Remove electrodes.
Inspect o-rings and
reassemble.
b) Replace pump tubing.
5. Pump tubing obstructed. Replace pump tubing.
6. Dirty sample cup. Clean with cotton swab and
DI water.

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Symptom Problem Correction (continued)

Air in Sample and 1. Sample and Calibrant A are a) Electrodes are not properly
Calibrant A segmented with air. seated or compressed. Check
compression plate, spring, and
seal. Remove and reassemble
electrodes.
2. Fibrin or salt is plugging the a) Use Cleaning procedure
electrode flow path. <CLEN>.
b) Remove electrodes and clean
or replace electrode with plugged
flow path. Reinstall electrodes and
recalibrate.
3. Bubble detector is malfunctioning. Replace bubble detector.
4. Waste pump is malfunctioning. Replace waste pump.
5. Dirty sample cup. Clean with cotton swab and
DI water.

Air in Calibrant B and 1. Calibrant B and Calibrant A a) Electrodes are not properly
Air in Calibrant A are segmented with air. seated. Check compression
plate, spring and seal.
b) Ensure that all electrodes and
o-rings are properly installed.
c) Ensure tubing between
reagent pack and sample
entry port is connected properly.
d) Replace tubing between
reagent pack and sample
entry port.
e) Reagent low or out.
2. Fibrin or salt is plugging the a) Use Cleaning procedure
electrode flow path. <CLEN>.
b) Remove electrodes
and clean or replace electrode
with plugged flow path. Reinstall
electrodes and recalibrate.
3. Waste pump malfunction. Replace waste pump.
4. Bubble Detector malfunction. Replace bubble detector.

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 o t r o u b l e s h o o t i n g

Symptom Problem Correction

Air in Calibrant A 1. Calibrant A. Replace reagent pack with a

new one, prime, and recalibrate.
2. Tubing from reagent Reconnect or replace tubing.
module is disconnected,
plugged, or crimped.
3. Calibrant A pump is not a) Check electrical connections.
working properly. b) Replace pump tubing.
c) Replace motor.
d) Replace pump.

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Error Codes
Error codes transmitted are only relevant to the cycle which generated the error. Subsequent cycles will
not be affected by previous error codes, and the ISE module will always report results. Therefore note
that if the slope value for a Calibration Cycle is outside of the acceptable range, the ISE module will
report an error code for that slope cycle. However, subsequent Sample Cycles will not report an error
(provided that the measurement was good), regardless of the slope condition. Note that sample results
following an unsuccessful calibration are not valid. It is the responsibility of the host analyzer to flag or
block results that might be unacceptable.
Error codes are transmitted as a consequence of two separate events. In the first instance, an error
code appears embedded in the result string of every calibration and sample analysis. The errors (or
lack of errors) identified by this error code are related to measurement limits exceeded in the just
completed cycle. In the second instance, an error code is transmitted independent of a result string and
relates directly to a failure to complete an assigned task. The errors identified by this error code are
related to fluid positioning and device operation. The two error types are mutually exclusive within a
cycle. Receiving an independent error code precludes receiving a result string. Receiving a result string
means no device errors occurred within the cycle. The table on page 58 describes how to decode
either type of error message.
Error Codes in Result Strings
<SER LI 0.50 NA 14.2 K 3.67 CL 125.0 0XXXXXXC>
and
<CAL LI 50.65 NA 58.06 K 56.91 CL 52.45 0XXXXXXC>
are examples of result strings. The forty-fifth character in the string is the start of the error code. This
character will always be a “0.” The following 6 characters, represented by X, will indicate a specific
error depending on the type of cycle the result string is reporting (the character represented by C is the
checksum). For example:
<SER LI 0.50 NA 14.2 K 3.67 CL 125.0 0004040C> indicates the K sample measurement exceeded
the noise limit and the K Calibrant A measurement drifted in excess of the limit with respect to its last
Calibrant A measurement.
<CAL LI 50.65 NA 58.06 K 56.91 CL 40.32 0000008C> indicates the CL slope measurement
exceeded the lower limit.
Independent Error Codes
<ERC URN X000000C> is an example of an error code sent in an independent error message.
The ninth character in the string, represented by “X” indicates the error condition. The following 6
characters will always be “0.” For example, the error message <ERC URN S000000C> indicates that
an insufficient sample of urine was dispensed into the module’s sample cup and the analysis could not
be completed.

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APPENDIX A

ISE Module Error Messages

Digit #1 Digit #2 Digit #3 Digit #4 Digit #5 Digit #6 Digit #7

Air/ mV Out mV Out mV Noise mV Noise Cal A Drift Out of Slope/

Hardware Cal B/Sample Cal A in Cal B/Sample Cal A in in Sample, Machine Ranges
Calib/Sample Mode, Calib/Sample Mode, Slope
Cal B in Cal B in Drift in
Urine Mode Urine Mode Calib
Error
Air in Sample/Urine S 0 0 0 0 0 0
Air in Calibrant A A 0 0 0 0 0 0
Air in Calibrant B B 0 0 0 0 0 0
Air in Cleaner C 0 0 0 0 0 0
Air in Segment M 0 0 0 0 0 0
Pump Cal P 0 0 0 0 0 0
No Flow F 0 0 0 0 0 0
Bubble Detector D 0 0 0 0 0 0
Dallas Read R 0 0 0 0 0 0
Dallas Write W 0 0 0 0 0 0
Invalid Command T 0 0 0 0 0 0

No Error 0 0 0 0 0 0 0
Li+ 0 1 1 1 1 1 1
Na+ 0 2 2 2 2 2 2
Na+, Li+ 0 3 3 3 3 3 3
K+ 0 4 4 4 4 4 4
K+, Li+ 0 5 5 5 5 5 5
K+, Na+ 0 6 6 6 6 6 6
K+, Na+, Li+ 0 7 7 7 7 7 7
Cl- 0 8 8 8 8 8 8
Cl-, Li+ 0 9 9 9 9 9 9
Cl-, Na+ 0 A A A A A A
Cl-, Na+, Li+ 0 B B B B B B
Cl-, K+ 0 C C C C C C
Cl-, K+, Li+ 0 D D D D D D
Cl-, K+, Na+ 0 E E E E E E
Cl-, K+, Na+, Li+ 0 F F F F F F

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 a p p e n d i x x

APPENDIX B

Formulation: Solution, Calibrant A

OEM 004154-001

Formula

Item Description

1 DI Water

2 Potassium Chloride

3 Sodium Chloride

4 Lithium Chloride

5 Buffer

6 Preservative

7 Surfactant

Formulation: Solution, Calibrant B

OEM 004155-001

Formula

Item Description

1 DI Water

2 Potassium Chloride

3 Sodium Chloride

4 Lithium Chloride

5 Sodium Acetate

6 Viscosity Adjuster

7 Preservative

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 r a p p e n d i x

Formulation: Solution, Urine Diluent

OEM 004160-001

Formula

Item Description

1 Buffers

2 Viscosity Adjuster

3 Preservative

4 DI water

Formulation: Solution, Daily Cleaner

Formula

Item Description

1 Pepsin

2 HCl (Hydrochloric Acid)

3 Ammonium Bifluoride

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 a p p e n d i x x

APPENDIX C

ASCII Character Codes

Following is the representation for the first 128 ASCII character codes. The BASIC manual provides the
remaining 128 characters. Note that hex 20 is the standard space or blank.

Table A-1 ASCII Character Set.

Dec Hex Char Dec Hex Char Dec Hex Char Dec Hex Char

000 00H Null 032 20H sp 064 40H @ 096 60H `

001 01H Start heading 033 21H ! 065 41H A 097 61H a
002 02H Start text 034 22H “ 066 42H B 098 62H b
003 03H End text 035 23H # 067 43H C 099 63H c
004 04H End transmit 036 24H $ 068 44H D 100 64H d
005 05H Enquiry 037 25H % 069 45H E 101 65H e
006 06H Acknowledge 038 26H & 070 46H F 102 66H f
007 07H Bell 039 27H ‘ 071 47H G 103 67H g
008 08H Back space 040 28H ( 072 48H H 104 68H h
009 09H Horiz. tab 041 29H ) 073 49H I 105 69H i
010 0AH Line feed 042 2AH * 074 4AH J 106 6AH j
011 0BH Vertical tab 043 2BH + 075 4BH K 107 6BH k
012 0CH Form feed 044 2CH , 076 4CH L 108 6CH l
013 0DH Carriage ret 045 2DH – 077 4DH M 109 6DH m
014 0EH Shift out 046 2EH . 078 4EH N 110 6EH n
015 0FH Shift in 047 2FH / 079 4FH O 111 6FH o
016 10H Data line esc 048 30H 0 080 50H P 112 70H p
017 11H Dev ctl 1 049 31H 1 081 51H Q 113 71H q
018 12H Dev ctl 2 050 32H 2 082 52H R 114 72H r
019 13H Dev ctl 3 051 33H 3 083 53H S 115 73H s
020 14H Dev ctl 4 052 34H 4 084 54H T 116 74H t
021 15H Neg acknowledg 053 35H 5 085 55H U 117 75H u
022 16H Synch Idle 054 36H 6 086 56H V 118 76H v
023 17H End tran block 055 37H 7 087 57H W 119 77H w
024 18H Cancel 056 38H 8 088 58H X 120 78H x
025 19H End of medium 057 39H 9 089 59H Y 121 79H y
026 1AH Substitute 058 3AH : 090 5AH Z 122 7AH z
027 1BH Escape 059 3BH ; 091 5BH [ 123 7BH {
028 1CH File separator 060 3CH < 092 5CH \ 124 7CH |
029 1DH Group separ. 061 3DH = 093 5DH 125 7DH }
030 1EH Record separ. 062 3EH > 094 5EH ^ 126 7EH ~
031 1FH Unit separ. 063 3FH ? 095 5FH — 127 7FH DEL

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For Service or Technical Assistance call:

800 777 5983 (in Continental U.S.)
781 275 4892 (International)

Medica Corporation
5 Oak Park Drive Bedford MA 01730-1413 USA
www.medicacorp.com

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