TECIL ISEsweatII User Manual
ISEsweat II
®
Sweat Chloride Analyzer
User’s manual
V00EVP012014
INDEX
1. INTRODUCTION ........................................................................................................................ 5
1.1 ISEsweat intended use............................................................................................ 6
1.2 Operating principles ............................................................................................... 6
1.3 How to use this manual .......................................................................................... 7
2. DEVICE DESCRIPTION ............................................................................................................. 8
2.1 ISEsweat ................................................................................................................ 9
2.2 Terminal or receiver base ..................................................................................... 10
2.3
Remote module ................................................................................................... 11
2.4 SENSOR CARDS ..................................................................................................... 12
3. ISESWEAT INSTALLATION ................................................................................................. 13
3.1 Components ......................................................................................................... 14
3.2 Power source connection ..................................................................................... 14
3.3 Battery ................................................................................................................. 16
4. SWEAT ANALYSIS .................................................................................................................. 19
4.1 Settings ................................................................................................................ 20
4.2 Sweat induction and analysis ................................................................................ 22
4.3 Interpreting of sweat test results .......................................................................... 27
4.4 Calibration and control ......................................................................................... 27
4.5 Quality Control Mode (QC)-ISEtrol N and ISEtrol A ................................................ 28
5. DATA PORT USE..................................................................................................................... 30
5.1 General summary ................................................................................................. 31
5.2 Data port connection............................................................................................ 31
5.3 Print Data ............................................................................................................. 31
5.4 Memory ............................................................................................................... 33
6. MAINTENANCE ....................................................................................................................... 35
6.1 Technical service .................................................................................................. 36
6.2 Periodic security check ......................................................................................... 36
6.3 Cleaning ............................................................................................................... 36
6.4 Waste management ............................................................................................. 37
ANNEX A: TROUBLESHOOTING TABLE ................................................................................... 38
ANNEX B PRODUCT SPECIFICATIONS ..................................................................................... 40
ANNEX C POSSIBLE INTERFERENCE ........................................................................................ 43
ANNEX D RECOMMENDATIONS FOR THE RESULTS INTERPRETATION ...................... 45
ANNEX E SYMBOL DEFINITIONS ............................................................................................... 47
ANNEX F REGULATIONS ............................................................................................................... 50
ANNEX G MANUFACTURER DECLARATION ........................................................................... 53
ANNEX H WARRANTY ................................................................................................................... 56
ANNEX I HISTORY SWEAT TEST ................................................................................................ 58
ANNEX J REFERENCE ..................................................................................................................... 60
1. INTRODUCTION
ISEsweat
- User’s Manual 6
1.1 ISEsweat intended use
ISEsweat is intended for quantitative pilocarpine iontophoresis sweat chloride testing for the
diagnosis of cystic fibrosis.
ISEsweat should only be used by Doctors, nurses and trained laboratory personnel. It is
highly recommended that users gain prior experience before diagnosing Cystic Fibrosis.
The place for testing may be in laboratories, hospitals or clinics
In order to increase the possibility of collecting an adequate sweat sample, it is advisable to
conduct the first chloride sweat determination tests on individuals older than 2 weeks and
weighing above 2kg.
Sweat volumes are dependant on age, sex, corporal weight, race, skin condition and
sampling system.
ISEsweat® is a Sweat Chloride Analyzer intended for Cystic Fibrosis Diagnosis.
CAUTION: ISEsweat® is intended only as a supplement in a patients’ evaluation. It must
be used in conjunction with other signs and symptoms. Don’t take any clinical decision
based only on the sweat test evaluations.
1.2 Operating principles
Cystic fibrosis is a multisystem disorder that causes formation and accumulation of dense
mucus, that affects mainly lungs, intestines, pancreas, and liver. Cystic fibrosis is also
characterized by the presence of a high chloride (Cl-) concentration in sweat, which is the
basisi of this diagnosis: (commonly known as the sweat test). This test QUANTIFIES the
chloride levels excreted while sweating, and is indicative for CF diagnosis.
The ISEsweat® runs the sweat test in two different stages: IONTOPHORESIS or sweat
stimulation and MEASUREMENT of the chloride concentration.
The first phase is called IONTOPHORESIS because sweat stimulation is done using this
technique. Its purpose is to get a sweat stimulating drug, pilocarpine, through the skin, with
the help of an electrical potential difference. Pilocarpine excites the sweat glands and
stimulates sweat on the treated area. Once there is enough sweat, the second phase begins.
The amount of pilocarpine delivered varies directly in proportion to the current and time
according to the Faraday equation below:
The second phase is called the MEASUREMENT phase. Chloride ion (Cl-) concentration is
measured in the sweat produced by iontophoresis. The analysis is made without any need to
i Intensity in mA
t Iontophoresis time
Mw Pilocarpine molecular weight
F Faraday constant
P mg of released pilocarpine
ISEsweat
- User’s Manual 7
manipulate the sample, using the microsensors on the Measurement side of the sensor card.
There is no need to collect the sample, it is analyzed at once, thus avoiding evaporation or
pollution problems.
Results obtained by the sensor card are transmitted by the remote module, and processed at
the ISEsweat® base, to give the chloride ion concentration. ISEsweat® uses the direct
potentiometry method, with a chloride ion selective electrode (commonly called ISE),
responding only to the Cl ion in the sweat. The relation between the developed voltage and
chloride ion concentration is logarithmic, and it is expressed by the Nernst equation:
The analyzer measures the electrode potentials, and the data is processed by a
microprocessor to calculate the chloride ion concentration.
1.3 How to use this manual
This user manual has been produced by Tecil in order to guarantee the correct use of the
ISEsweat® equipment. Before putting the equipment to work, please read carefully all pages
and, if you have any doubts, contact the relevant department. Only authorized Tecil agents
can translate this manual.
Information in this manual can be changed without prior warning. This product is permanently
being developed and perfected. The manufacturer keeps the right to make any modification
on the design features without prior warning.
E Potential of electrode in contact with sample
E° Potential of reference electrode
RT/nF Temperature constant
N Valency (chloride ion is 1)
Log Logarithm base 10
γ Chloride ion activity coefficient
C Analyzed ion concentration
Tecil, S.A.
Lope de Vega 99-101
08005 Barcelona (Spain)
Web: www.tecil.com
E-mail: calidad@tecil.com
Phone: + 34 902995746
Fax: + 34 933084871
2. Device description
ISEsweat
- User’s Manual 9
2.1 ISEsweat
ISEsweat® is intended for use by qualified personnel to measure chloride in sweat. The
resulting concentration value of patient´s sweat is used for diagnosis of cystic fibrosis.
The current for iontophoresis was reduced to 0.4 mA, to minimize the risk of causing irritation
to the patient. After 10 minute of iontophoresis, the stimulated area is washed with distilled
water, and reverse face of sensor card is placed. After 15 minutes the concentration of
chloride directly from the skin of the patient is measured. The data is then transferred to the
base by radiofrequency ( RF) and the value of chloride is displayed in mmol/l.
The analyzer consists of 2 separate parts:
1. Terminal or receiver base, includes: an LCD screen where results of the
analysis are displayed;
2. Remote module, has just one push button on the front. This remote module has
the holder for the innovative disposable sensor card patented by Tecil which are
involved with the stimulation, sweat collection and reading the chloride
concentration obtained from the patient’s sample.
ISEsweat® uses a detachable sensor card to run each sweat test. They consist of two
different sides; each one performs a different process (IONTO side and MEASURE side).
Once the card package is opened, each sides have a different appearance, thus making it
difficult to make a mistake when choosing the appropriate side. In the event of mistake,
ISEsweat will alert you about wrong side placed !!
ISEsweat
- User’s Manual 10
2.2 Terminal or receiver base
Receiver unit for the reception of data coming from the remote analyzer module, display and
record in the internal data base memory
Display:
Appears all the information about
the test ( phase, time remaning…)
Base LED:
It turns orange or green at the
same time as the charge led indicator on the
remote. When it’s orange is “charging” and
when is “green” is charged.
Control panel:
This four buttons helps the
user to move around the interphase on the
software’s base. Their function could change,
depending on which screen appears on the
base.
Remote module slot
:
It’s a connector to
charge the remote battery, once the base of
the remote It’s plugged in on this slot.
On/Off switch:
Turns On or Off the base of
the ISEsweat.
AC Power supply connector:
Side where
plug the power supply connector to the base
of ISEsweat.
Printer connector: Port to connect a
printer serial cable, to print the results.
USB port connector: Port to connect an
USB cable to a PC.
Control panel, to access to different
functions
Display
Base LED
Remote module slot
On/Off switch
AC Power supply
connector
Printer connector
USB port connector
ISEsweat
- User’s Manual 11
2.3 Remote module
Remote LED indicator: Indicates the
phase of sweat test, and if there’s some
problem, using a two colour LED.
Charge LED indicator: Indicates if it’s
charging (orange) or fully charged
(green).
Remote push button: Pressing this
button: starts, changes the phase and
stop the remote.
Sensor card slot: Slot where the sensor
cards are connected to run the
iontophoresis, and the measurement
phase.
On/Off switch: Turns On/Off the
Remote.
Charge contacts: Contacts where the
remote it’s plugged to the remote module
slot
Remote LED
indicator
Charge LED indicator
Remote push
button
Sensor card
slot
On/Off switch
Charge contacts
ISEsweat
- User’s Manual 12
2.4 SENSOR CARDS
ISEsweat® uses a sensor card to run the analysis or sweat test. It consist of two different
sides; each one performs a different process (IONTO side and MEASURE side). The name
of each side alludes to its function.
Once the card package is opened, you can distinguish these two sides by the appearance,
thus making it difficult to make a mistake when choosing the approriate side.
IONTO SIDE this stimulates sweat on the
patient through two square-shaped hydrogel
iontophoresis pads containing a solution of 0.5%
pilocarpine nitrate.
MEASURE SIDE this measures the chloride
concentration (sample or control) through the ISE
technique. It consists of 2 concentric circular
electrodes, covered by a transit gel that the user
has to remove before using.
Gels
Connector
Connector
Electrodes
3. ISEsweat installation
ISEsweat
- User’s Manual 14
3.1 Components
Use the list in the following table to check that you have received all needed components.
If any of the components are missing or damaged, please inform your distributor at once.
TECIL only takes responsibility for notifications received within 72 hours after product
delivery. Once notified, you have 15 days from the receipt date to effect any return.
Use only the recommended accessories. If you have any doubts, please contact your
distributor or the manufacturer.
It is recommended that you keep the packaging material in case it is needed for further
transport.
Packing List
CODE DESCRIPTION
T601
Complete ISEsweat®
T611
Receiver base
T620
Transmitter module (remote)
T700
Sensor cards
T800
Quality Control Kit
T900
DC 12v Power supply unit 1,5 A
T901
Printer Series Dock Cable – OPTIONAL
T902
USB cord - OPTIONAL
T903
Armband
TM-U220DS
Printer Series Dock - OPTIONAL
T908
Power Cord
3.2 Power source connection
WARNING: When you connect the ISEsweat, check that it works correctly before using it for
clinical purposes. The accessories connected to the ISEsweat® data interface must comply with
IEC EN 60950 regulations for data processing equipment certificate or IEC EN 60601-1
regulations for electrical medical equipment certificate. Any person that connects other
equipment to the input/output ports (ISEsweat® data port connector) is configuring medical
equipment, and as such is responsible for guaranteeing that the system follows the IEC EN
60601-1-1 and EN 60601-2 Regulations for electromagnetic compatibility. All accessories
supplied by TECIL comply with all these regulations. Connect the equipment to a power
supply with an earth connection.
WARNING: Use the equipment in dust free, mechanical vibration free and electrical
interference free areas. Avoid the proximity of brush motors (in some centrifuges), heat
sources or blinking fluorescent lights. Readings and signals could be affected.
CAUTION: DO NOT lift the ISEsweat® base by the power supply cable; it could become
disconnected and damage the ISEsweat®.
ISEsweat
- User’s Manual 15
CAUTION: DO NOT soak the equipment in water or put it in a very high humidity area.
CAUTION: In order to guarantee patient security and that the equipment remains in good
condition, DO NOT place the ISEsweat® in any place from where it could easily fall.
CAUTION: DO NOT use the ISEsweat® in the presence of anesthetics or flammable gases to
avoid risk of explsion.
Study the figure below and follow the instructions in order to make the power supply
connection.
2 – Power supply On/Off switch
3 – AC power supply connector CA
1. Plug the power supply cord connector to the power supply connector (3).
2. Plug the power supply cord to a CA power network point with an earth connection
(Shuko type).
3. Press the power On/Off switch (— / O) (2) to the ON position (— symbol) to start up.
When connecting the equipment to the power network, please ensure that it cannot become
easily disconnected. After connecting and installing the ISEsweat®, press the power switch to
the ON position (—), to initiate the program. ISEsweat® makes an acoustic signal (1 beep)
and the base LED indicator will light (orange) and come on for a second. When the left hand
switch is turned on, the following software load screen will appear on the ISEsweat® screen
for 10 seconds.
1. Product brand
2. Company
3. Software version – Work mode
4. Work frequency – Base number / Linked remote number
2
3
1
2
3
4
ISEsweat
- User’s Manual 16
3.3 Battery
The ISEsweat® transmitter module or remote includes a Lithium-ion (Li-ion) battery with a
650mAh capacity that allows it to work. When completely charged the battery will last for 6
hours and allow for 10 analyses.
It is highly recommended that the internal battery is replace every 2 or 3 years, depending on
the use. Batteries capacity decreases with use (see Battery replacement section).
If the ISEsweat® is not going to be used for some time, it is recommended that you get in
contact with the technical support service, and disconnect the remote using the switch on the
front side.
Recharge the battery before using if it has been inactive for 3 months or more.
WARNING: ISEsweat® remote will not work if the battery is completely flat. Please, check the
battery state before using the remote (see Battery Indicators).
Battery indicator
During use, you can check the battery charge state by referring to the symbol on the upper
left hand corner of the base screen. The battery indicator appears once the analysis has
begun.
Charged
battery
Battery at
medium/low level
Discharged
battery
WARNING: Starting an analysis with a low battery level can influence the results. It is highly
recommended that you recharge the battery level whenever it is low. Please, check that the
remote has an adequate battery charge level before running the analysis; otherwise, the
battery may discharge during the analysis. After running an analysis, plug the remote module
into the base charger slot until next analysis, to avoid getting a flat battery.
Charging process
The Battery will only recharge if ISEsweat® is connected to a CA power supply ( BASE ON
and REMOTE OFF) . Therefore, it is recommended that the ISEsweat® base is always
connected to the CA power supply, and that the remote is left in the charging slot, so the
battery is fully charged for remote use at anytime.
NOTE: Distinction between connection and operation.
Operation refers to any part of the analysis (sweat test) or quality control phases, where the
remote module is in use.
ISEsweat
- User’s Manual 17
However, connection refers to the starting up/shutting down of the remote module
using the switch at the lower side. If the remote is shut down it won’t work; there is no
power.
To start the charging process, please follow the instructions below:
1. Interrupt the equipment operation
In order to start the charging process, the remote must not be operating. The screen
on the Base Unit should be showing the Start Screen or the Previous Phase, not any
of the running mode screens, (measurement, ionto, wait, etc…)
To make sure the remote is not operating:
1. Press for 4-5 seconds the remote central button, until the remote LED turns
orange.
2. Release the button when the LED color changes. The remote is now switched
off and the remote LED indicator is should be off.
2. Remote disconnection
Once the remote is not operating and before starting the charging, please disconnect the
remote completely by switching the side switch to OFF.
WARNING: During a test session you can continue to charge the equipment without
disconnecting the remote but in this case, you will not be able to check that it is fully charged
(green LED) because of the power the remote is consuming. After ending the test session,
please disconnect the equipment and put the remote in the charging position, as described
above, to achieve a full charge.
3. Charging
To charge the battery, put the remote in the charge slot on the ISEsweat® base unit, as
shown in the following figure.,The estimated time to achieve a full battery charge is around
6 or 7 hours.
Once the remote is in the charging slot, the base and remote LED indicators (LED) will light
up, and will give information on the charge state, changing from orange/red to green/green
as shown,.
ORANGE
ISEsweat
- User’s Manual 18
Charge light signals indicators:
Battery state
Remote LED
Base LED
Discharged Orange* Orange
Charged Green Green
*No more than 7 hours. In any other case, check Problems chapter.
Once the battery is fully charged, base and remote LEDs will glow GREEN, thus indicating
the battery is at full charge.
The remote module can remain connected to the base indefinitely, without any problems for
the equipment. LED indicator will remain GREEN at all times.
WARNING: Make sure when using the remote again, to set the side switch to the ON position.
In fact it won’t connect to the Base Unit or work at all until you do this. If after charging for 7
hours, the remote LED is still showing Orange, there is the possibility that you have
forgotten to disconnect the remote, because the remote’s minimum power consumption
prevents the remote from becoming fully charged (Green LED).
WARNING: If you remove the remote from the charging slot with the green LED showing
(charged battery) and replace the remote back in the slot the LED will glow red for a few
moments even though the battery is fully charged,, because the remote needs some time to
check the battery state.
Battery change
The advantages of the Lithium Ion batteries are, among other things, the lightness of their
components, their high power capacity and their capacity to operate with a high number of
regeneration cycles. However, the battery life will deteriorate over time. The number of
battery charge/discharge cycles will determine its service life; with regular use, its useful life
is estimated at between 2 and 3 years. It is highly recommended that the battery is left in the
charging position when you don’t expect to be using it for a long time. As said before, check
the Problems chapter if you observe any charging anomaly.
Remote indicator LED will emit a RED light if the battery state is not good, thus showing a
problem in the battery.
CAUTION: Battery replacement can only be made by the TECIL Technical Support team or a
TECIL authorized technical expert.
ORANGE
ORANGE
GREEN
GREEN
4. Sweat analysis
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