1 Table of Content

Table of Content

Table of Content ____________________________________________________________ 1

1. General Description of the System __________________________________________ 3
1.1. Device Features___________________________________________________________ 3
1.2. General information _______________________________________________________ 4
1.3. Specifications ____________________________________________________________ 5
1.4. Consumables _____________________________________________________________ 6
1.5. Measuring principle (Glucose) _______________________________________________ 7
1.6. Measuring principle (Lactate)________________________________________________ 7

2. Installation _____________________________________________________________ 8
2.1. Unpacking _______________________________________________________________ 8
2.2. Setting up the analyzer _____________________________________________________ 8
2.3. External connections ______________________________________________________ 9
2.4. Printer _________________________________________________________________ 10
2.4.1. Feeding the thermal printing paper _______________________________________________ 10

2.5. Starting up the device_____________________________________________________ 11

2.6. Display Icons ____________________________________________________________ 12
2.6.1. Measurement Memory ________________________________________________________ 13
2.6.2. Calibration mode _____________________________________________________________ 15
2.6.3. Standby-Mode _______________________________________________________________ 15

3. Measuring samples _____________________________________________________ 16

3.1. Preparation of samples____________________________________________________ 16
3.2. Measurement of control samples ___________________________________________ 17
3.3. Measurement of patient samples ___________________________________________ 17
3.3.1. Emergency measurements ______________________________________________________ 19

4. System Configuration / Menu _____________________________________________ 20

4.1. Measuring unit __________________________________________________________ 20
4.2. Date/Time ______________________________________________________________ 20
4.3. Reagent bottle __________________________________________________________ 21
4.4. Status__________________________________________________________________ 22
4.5. Quality management / QM ________________________________________________ 23
4.6. Settings ________________________________________________________________ 23
4.6.1. Measuring mode ______________________________________________________________ 24
4.6.2. Limits of Controls _____________________________________________________________ 24
4.6.3. Limits Double Measurement ____________________________________________________ 25
2 General Description of the System

4.6.4. Base settings _________________________________________________________________ 26

4.6.5. Device settings _______________________________________________________________ 34

5. Changing the sensor ____________________________________________________ 42

6. Care and Maintenance __________________________________________________ 44
6.1. Changing the pumptube ___________________________________________________ 44
6.2. Replacing the exchanger___________________________________________________ 45
6.3. General hints ____________________________________________________________ 46
6.3.1. Touchscreen _________________________________________________________________ 46
6.3.2. Labeling of the sample cups _____________________________________________________ 46
6.3.3. Storage of the device when it is not used __________________________________________ 46
6.3.4. Shipment of the device _________________________________________________________ 46

7. Appendix _____________________________________________________________ 47
7.1. Used Symbols ___________________________________________________________ 47
7.2. Hotline _________________________________________________________________ 47
7.3. EC-Declaration of conformity _______________________________________________ 48

Rev. 6: 2013-05-0612
 General Description of the System 3

1. General Description of the System

1.1. Device Features

integrated Thermal Printer Ceramic Chip Technology

Colour Touch screen

Accessory Compartment

20 Samples plus 3 Controls Tray

Pump Tube Access

The picture shows the ecoTwenty; ecomatic and ecobasic are similar, only sample trays are different.
4 General Description of the System

1.2. General information

Maintenance

The devices (ecomatic, ecoTwenty, ecobasic) should only be operated by qualified

persons and only used for the described purpose.
The device must be handled carefully. It is also important to keep the outside surface
clean in order to prevent dust from entering the inside of the device.
It is strongly recommended that the valve system on the aspiration probe and the
tubes leading to the pump be checked or replaced every six months.

Colour Touch screen

For the cleaning of the display use soft cloth moistened with ethanol. Take care not to
allow ethanol to soak into the joint of upper film and bottom glass. It may otherwise
cause peeling or defective operation. Do not use any organic solvent or detergent
other than ethanol.
For the operation use the provided Touch screen pen or a belly of the finger without
applying excessive load. Never use any mechanical pencils, ball point balls and hard
fingertips, otherwise malfunctions may result.

Electrical Sockets

The analyzer is only to be used in rooms meeting VDE 0107 specification. Please
note DIN VDE 0750 part 1/ 12.91 with regard to electrical plugs and sockets.

Safe connection with other electrical devices

Safe connection with other electrical devices is only possible after consulting the
manufacturer.

Liability for damages or functions

The manufacturer is not liable and can not be made responsible in any form for
damage that is caused by improper use of the analyzer or use not conforming to the
instructions in the Operating Manual.
This device is not suitable for use with danger of explosion or nearby areas where
explosive material is used.
 General Description of the System 5

1.3. Specifications

ecomatic ecoTwenty ecobasic

Manufacturer CARE diagnostica GmbH
Type of Product Blood glucose/lactate analyzer
Dimension
Size (mm) 400x430x245 295x350x245 270x290x240
Weight (kg) 6,5 5,2 4,1
Measuring principle enzymatic-amperometric
Measuring range glucose 1 - 50 mmol/l (18 - 900 mg/dl)
Precision (glucose) < 3 % at 12 mmol/l
Measuring range lactate 0.8 - 25.0 mmol/l
Precision (lactate) < 5 % at 12 mmol/l
Measuring speed about 100 samples/h only 1 parameter
about 80 samples/h measuring both parameter
Sample material whole blood, serum or plasma
Sample volume 20 µl sample and
1000 µl reagent
(system solution)
also possible: 10 µl sample and 1000 µl reagent
Sample:reagent ratio 1:51
Sample identification 1-999
Capacity of sample Tray 50 samples 20 samples 10 samples
Life time of sensor (glucose) min. 30 days or 5000 analysis
Life time of sensor (lactate) min. 20 days or 3000 analysis
Storage conditions
Allowed temperature a-20 to 70 C (analyzer stored without sensor)
Air pressure 600 - 1300 hPa
Humidity 20 to 95 % rel. Humidity
Electrical Input
Mains connection DC: 12 - 3300 mA external Power Supply
Power consumption Max. 20 VA, average 15 VA
RS 323 (ext. printer or Lab-EDP), internal printer and
External connections USB
Automatic calibration Every 30 minutes (adjustable)

Technical changes without prior notice!

6 General Description of the System

1.4. Consumables
With glucose/lactate analyzers of the “eco”-series it is possible to measure Glucose
and/or Lactate. For this the following consumables are needed:

REF Description Unit

866 620 Sample Cups 2,0 ml, clear, prefilled 1000 pieces
866 621C System Solution Concentrate 500 ml
866 621 System Solution 500 ml
866 642 Glucose/Lactate Standard Solution 8 x 50 ml
866 641 2-Channel-Sensor Glucose/Lactate 2 pieces
866 627 Synthetic Capillaries 20 µl 1000 pieces
866 631 Synthetic Capillaries 10 µl 1000 pieces
E 747802 Thermal paper for integrated thermal printer 10 rolls
(optional)

Unopened, the reagents are stable up to the indicated expiry date, as on the labels
indicated. The sensor should be stored kept from light at room temperature. After the
opening of the calibrator container the calibrator is usable for 8 weeks. However, the
container has to be closed after use immediately.
Only in very rare cases glucose and lactate is measured simultaneously from one
sample. Please notice that the sample collection for the lactate measurement should
always be done at the ear. Since sweat contains a large volume of lactate the sample
collection at the finger will lead to big problems.
If you want to measure only Glucose it is recommended to replace the
Glucose/Lactate standard by below consumable.

REF Description Unit

866 623 Glucose Standard Solution 8 x 50 ml

For lactate measurement alone, you should also use a different standard solution,
the sensor to be used is the same.

REF Description Unit

866 623L Lactate Standard Solution 8 x 50 ml
 General Description of the System 7

1.5. Measuring principle (Glucose)

The sample is automatically aspirated into the sensor-system. The glucose in the
blood is enzymatically transformed with GOD. The amount of the resulting product
(H202) is quantitively determined by the sensor. After the measurement, the sensor-
system is automatically cleaned and prepared for the next measurement.
All operations, measurements, and maintenance are controlled by a microcontroller.
This chip processes all the signals coming from the sensors. Information and
errors/faults, such as the necessary change of the used consumables, are shown on
the display

ß-D-Glucose + O2 + H2O D-Gluconsäure + H2O2

Enzymmembran mit
GOD immobilisiert

H2O2 2 H+ + O2 + 2 e-

Platin-Sensor

1.6. Measuring principle (Lactate)

The basic principle for Lactate is the same as for Glucose. Instead of Glucose
Oxidase, the enzyme Lactate Oxidase (LOD) transforms the Lactate. It be produced
H202, which can be measured quantitatively.
8 Installation

2. Installation

2.1. Unpacking

After receiving the device, examine the exterior carton for damages. In case of
shipping damage a claim must be filed with the transportation carrier. Carefully
unpack the unit and check for completeness. Included upon delivery are the
following:
device 1
Integrated thermal printer optional
Thermal printer paper optional
12 V DC power adapter 1
operation manual 1
Waste bottle 1
Touch Screen Pen 1 in the Accessory compartment,
at the ecobasic at the rear of instrument

Keep the original packing until the unit has been shown to be operating properly. If
any of these items are missing, contact your supplier immediately.

2.2. Setting up the analyzer

Choose a suitable place for the analyzer. In extreme cold conditions please wait
before switching on the device. The instrument should be used at room temperature
between 15 and 35°C (59 and 95°F). The rel. Humidity should be between 20 and
95%. Furthermore avoid direct sunlight, strong electromagnetic fields and large
temperature differences (heater, open windows etc.).
The provided power supply is designed to work within a range of 100 - 240V.
Remove the adapter for 110 volt usage. Be sure only to use the provided power
supply model STI-008-060.

PRI: 100-240V AC 50/60Hz SEC: 12V DC 4,5 A

 Installation 9

2.3. External connections

The device provides two external ports. Via the serial RS232 interface a serial printer
or a LabEDP can be connected.

The USB-socket provides export of measurement data, setting parameters and

firmware update by means of a USB flash Memory stick (FAT32, max 32 GB, not
included).
10 Installation

2.4. Printer

The ecomatic and ecoTwenty are equipped as standard with an integrated thermal
printer. At the ecobasic the printer is optional.

2.4.1. Feeding the thermal printing paper

The integrated printer is specified for a paper width of 57,5 mm (± 0,5 mm), with a
weight of 60 g/m², and with a winding diameter of 31 mm. Other paper may not be
suitable for use. We recommend the thermal paper with the REF E 747802 (10 rolls).

1. Unwind about 10 cm of paper from the roll. Keep the layers wound tightly.

2. Open the printer cover by slightly pressing the LEVER in the cover upwards. The
print roll is lifted from the mechanism together with the cover. The cover can be
opened now.

3. Insert the paper roll into the paper storage, so that the outside shows toward the
printer mechanism. Only this side can be printed.

4. Close the cover by applying strong pressure. You can hear it snap shut. Now you
can rip off paper at the tear bar without the cover opening up or the paper sliding
through the print head.

Use the feed button to transport the paper.

Feed Button
 Installation 11

2.5. Starting up the device

Be sure that a sensor is installed (otherwise install the sensor first, see chapter 5).
Connect the waste bottle to the analyzer. Then place a full bottle of System solution
into the device and connect the cap. Switch on the device by inserting the external
power supply into the device and the mains socket.
After a short moment the following display appears.

Please check the date and time.

If the Date/time isn´t correct, please adjust the right date/time by pressing the
button. For this see 4.2.

If the date/time is correct than press the button. The initialization process of the
system begins automatically. The system fills automatically and a 1 h warm up period
begins.
12 Installation

After this the device is ready to measure, and the following display appears:

2.6. Display Icons

The instrument is equipped with a pressure sensitive colour touchscreen. Use a

finger or the provided touchscreen-pen for all applications. Do not use sharp objects
which could damage the display.

“Start” Touching icon starts a measuring cycle.

“Menu” Touching this icon opens the menu with all important
device settings (see chapter 4).
 Installation 13

“Memory” Touching this icon opens a list of the previous

measurements.

“Single-Cal” Calibration mode

Touching this icon the user can choose between
“Single-“ and “Auto-Calibration”.

“Standby” Touching this icon the instruments goes down in the

standby mode.

2.6.1. Measurement Memory

When the instrument does not measure, previous measurements can be displayed
by touching the “Memory”-icon.
14 Installation

The results of up to 1000 measurements can be stored into the memory. With the

buttons you can scroll into the data.

It is a ring memory. If memory is full and its need another measurement to be stored,
previously the oldest measurement is deleted.

By touching the -button you can see the curve of the measured sample:

By touching the buttons the curve or the data will print out by the
integrated printer.

With button you will come back to the main menu.

 Installation 15

2.6.2. Calibration mode

Because of the nature of the enzyme, the sensor changes its sensitivity. Therefore it
is necessary to calibrate the device at certain intervals. It is possible to choose
between two kinds of calibration.

In the mode “Single-Cal” the calibration will be executed before

the measurement of patient samples.

In the mode “Auto-Cal” the calibration will be executed at

certain intervals. Therefore it is necessary that the position “ST”
always contains a filled cup of standard solution.

For a higher quality of the measurement the calibration mode “Single-Cal” is

recommended.

2.6.3. Standby-Mode

After 3 minutes of inactivity the device changes into the standby-mode.

All unnecessary and unused energy sources turn off at this mode. By touching the
display the standby mode is left.
16 Measuring samples

3. Measuring samples

3.1. Preparation of samples

With the device it is possible to measure whole blood, serum, plasma or liquor. All
samples have to be diluted in a ratio of 1:51.
For the analysis of samples lockable sample cups, prefilled with 1,0 ml system
solution (REF 866 620) are needed. For the sampling of the sample material, usually
20 µl end-to-end capillaries are used.
1. Take from the capillary blood with the 20 µl end-to-end capillary. Avoid air
bubbles.

2. Put the capillary into the prefilled sample cup and lock it well.

3. Shake it immediately extensively for a few seconds.

4. For the measurement place the sample into the tray of the device.

With one sample cup you can repeat the measurement of the same sample 4 times.

Sampling and Storage for Glucose only:

If only Glucose shall be tested, the capillary blood can be obtained from a pricked
finger. The sample can be kept for 24 hours in a closed sample cup.
At storage of the closed sample cups between 2 and 8 °C the sample is stable for 5
days.

Sampling and Storage for Lactate determinations:

If only lactate or lactate + glucose shall be tested, the sample should be taken from
the earlap, otherwise false results for lactate might occur. As lactate is not be stable
for a long period of time, the sample should be tested immediately.

Important: Incorrectly filled cups will lead to false measurements!

In order to achieve an accurate measurement the capillaries must
be completely filled without any air bubbles inside!
Important note for using of 10 µl capillaries:
It is also possible to use 10 µl end-to-end capillaries with 1 ml system solution. For
this please contact your supplier, he must change some system parameters. If 10 µl
capillaries are used, it is essential to wipe them off carefully before measuring
because even smallest amounts of blood on the outside of the capillary will have a
high influence on the measurement quality. The use of 20 µl capillaries is
recommended for achieving optimum measurement results.
Lactate measurements with 10 µl end-to-end capillaries are not possible.
 Measuring samples 17

3.2. Measurement of control samples

For the verification of the device it is recommended to measure control samples. The
ecomatic and ecoTwenty have three special control sample positions (K1, K2 and
K3) on the tray. The ecobasic has two special control sample positions (K1 and K2).
This control samples will be handled like patient samples.
The results will be compared with the set limit values for the control (see chapter
4.6.2). If the result exceeds the limits, the device stops automatically.

3.3. Measurement of patient samples

Every time when the “Start”-icon is displayed you can start a measurement cycle.
Before starting, the position “ST” on the tray must be filled with a standard/calibration
cup (empty cups filled with standard solution - REF 866 623 or prefilled standard
cups - REF 866 628).
The tray positions K1, K2, and K3 (at the ecobasic K1 and K2) are only for control
samples. The patient samples have to be inserted in the tray positions
1 to 10 (ecobasic),
1 to 20 (ecoTwenty),
and 1 to 50 (ecomatic).
Touch the “Start”-icon to start the measurement cycle.
The analyzer stops automatically if the calibration is not accepted or the control
samples do not meet the set limits. In this case perform a new calibration or make a
repeat measurement of the control sample.
18 Measuring samples

Glucose measurement:

Glucose/Lactate measurement:

After starting the measurement cycle the above display appears depending on the
selected measuring mode. If you touch the “Stop”-icon the measurement cycle stops
after the actual sample.

Important note for Glucose Measurement:

Measurements lower than 1,0 mmol/l (18 mg/dl) or higher than 50 mmol/l (900 mg/dl)
are not permitted as result for a patient therapy of any kind.
To prevent an eventual hyperglycemia we advise to dilute the sample with 1:1 (one
part sample and one part system solution) and then measure again.
 Measuring samples 19

3.3.1. Emergency measurements

If you want to measure an emergency sample during a routine, insert the sample cup
into
ecomatic: position 50
ecoTwenty: position 20
ecobasic: position 10

and press the icon. Then the tray rotates to the last position of the tray and
measures the “Urgency” sample. This procedure is only available if you measuring
samples.
20 System Configuration / Menu

4. System Configuration / Menu

In the system configuration menu the following submenus appears

4.1. Measuring unit

Press the icon top left to switch between mg/dl and mmol/l.
Please notice that in the measurement mode “Lactate” and “Glucose/Lactate” the
measuring unit always is mmol/l.

4.2. Date/Time
Pressing the button "date/time", the following page appears:

By selecting the appropriate numbers the date and the clock can set. With the arrow
buttons you can choose the correct position. The european notation is used
DD.MM.YYYY hh:mm
 System Configuration / Menu 21

4.3. Reagent bottle

The device can´t really recognize how much system solution is inside the bottle. The
device calculates the fluid level of the bottles by the executed pump-steps. Based on
this calculation the device should know when there is not enough system solution
inside the bottle and the waste bottle is full.
If the reagent bottle level is low the following message appears on the display

If the bottle is empty the following message appears:

For a correct function of this feature it is necessary to inform the device when the
buffer bottle has been exchanged.
22 System Configuration / Menu

For this purpose, please proceed as follows:

Fill the bottle for system solution and empty the waste bottle. Then touch the icon
„Reagent bottle”. The following display appears:

Please confirm by touching the “New Reagent bottle” icon. The system fills
automatically.

4.4. Status
By accessing this menu information about device, serial no., firmware version,
sensor voltage of the last calibration, sensor age, measurements, pump counter and
measurement mode are displayed:
 System Configuration / Menu 23

4.5. Quality management / QM

In Germany the guidelines of the German Medical Association for quality assurance
of quantitative laboratory tests (RiliBÄK) legally calls the daily measurement of
control samples. The instrument has an automatic quality management program for
the control measurements.
In order to activate this program, the parameter of the controls must be created. For
this purpose, the submenu "Quality management" is called. There are the following
sub-menus:

4.6. Settings
By pressing „Settings“ five additional submenus are called. In these menus the main
device settings can be made:
24 System Configuration / Menu

4.6.1. Measuring mode

In this submenu the measuring mode can be selected. It is possible to measure

• Glucose
• Glucose/Lactate

and

• Lactate

With the arrow buttons you switch between the different modes and confirm your

selection with the icon.

4.6.2. Limits of Controls

Under the menu item “Setpoints Controls” (see chapter ) the target values can be
entered depending on the Measuring Mode and instrument. Entering the target value
of the controls, the control limits (± 11% of target value) were directly calculated and
take over for the menu “limits of controls”.
The ecomatic and ecoTwenty can manage three different controls, the ecobasic can
manage two controls.

Under this menu you see the valid ranges of the controls.
 System Configuration / Menu 25

If the one control measurement is outside of this range, the instrument will stop
immediately and the message “LIMIT CONTROLS” appears on the display and is
printed out.

4.6.3. Limits Double Measurement

Samples that fall out of the given limits will automatically be measured a second time.
26 System Configuration / Menu

For the adjustment of the limits you must touch the number on the display with touch
screen pen. In the following display you can enter the limit value by touching the

wanted numbers. With the icon you can delete the entered value. For

confirmation touch the icon.

4.6.4. Base settings

At delivery certain basic settings are preset. Before the first measurement the
operator should check these settings and adjust it according to his wishes. By
selecting “basic settings” the following submenus appears:
 System Configuration / Menu 27

4.6.4.1. Acoustic Signals

Many operations of the device be accompanied by acoustic signals. Example include

• Stop of a measurement cycle

• Touch the Touchscreen

• error message of the device

In the menu item "Acoustic Signals" it can be chosen between „ON " or "OFF”.

4.6.4.2. Serial port function

Optional the instrument has a serial port (RS 232) for the connection to the LabEDP
or an external printer.

With the arrow keys it can be chosen between “none”; “Printer” and “IT”.

If “Printer” or “IT” is selected you must entering the port parameter after confirmation

with the button.

28 System Configuration / Menu

It can be selected among the following options:

Baudrate: 1200 / 2400 / 4800 / 9600
Data: 8/7
Parity: none (N) / odd (O) / even (E)
Stop bits: 1/2
48 different settings are possible.

In the further display

Preamble: <STX> / <STX> <CR> / <STX> <CR> <LF> /

<CR><LF> / <CR>
Postamble: <ETX> / <CR> <ETX> / <CR> <LF> <ETX> /
<CR><LF> / <CR>
IT-device No: 1, 2, 3, …

Method No.: 1, 2, 3, …
 System Configuration / Menu 29

4.6.4.3. Barcode scanner

The device is basically "barcode-ready", i.e. all functions, except for the barcode
scanners, hardware and software are available. For the full operation, only the
assembly of barcode scanner and the device setting is required.

The device can be configured in the “base settings” under the submenu “Barcode
scanner”:

By pressing the icon "Scanner on" the scanner is switch ON or OFF.

With the “Arrow” keys the minimum length for barcodes may be adjusted. If the
stucked barcode have not the minimum length it will not be accepted and not
covered.

The “Scanner test" is used to verify the barcode function of the device. It is possible
to establish whether the used barcode is supported or whether the barcode is
readable. For this put some stucked sample cups into different positions of the
sample plate. By pressing the icon “Scanner test” the device start to move to the
different mounted positions of the plate. The Cup will be briefly punctured and the
barcode is registered. The registered samples are serves out on the display and
printer.

The cleaning of the scanner window is carried out with great caution. Please use no
sharp or pointed objects. Don´t use to clean any acid, alkaline liquids or organic
solvents. Water is sufficient as a cleaning agent. Use a Q-tip or a lint-free paper for
the cleaning.
30 System Configuration / Menu

Create barcode
All popular barcodes are supported. Especially recommended is the use of 2 of 5
interleaved coding.

This full numerical code is the most appropriate, because at a confined space a high
number of digits can be encoded with an optimal code density.

Proposal for the design of the barcode label

Name:
7 Boundary
*)
4
max. 33
500173
Free area

12...30
20...30

*)if no label field is present, this measure can be reduced to 0 mm. The boundary is
be dropped

In the hand lettering of the label is important to ensure that the area below the
boundary line is not labeled, otherwise it can lead to read errors!

Positioning of the barcode label on the sample cup

Name: Scharnierseite
Side of hinge
Label schließt bündig
mit Cuprand ab
Label is flush to
500173

the top oft he cup

umschlagen
put on
 System Configuration / Menu 31

In accordance to the above figure the barcode label must be to be placed vertically
and horizontally centered on the hinge side of the cup. It should be noted that the
upper edge of the label located directly below the thickened rim of the cup seal. Now
you should touch on the label, starting from the center to the left and right around the
cup, so that abuts this wrinkl

500173

The cups are set up with the hinge side (barcode) to the outside into the sample
plate.

4.6.4.4. Print settings

Under this submenu you can print out the basic settings of the device.
32 System Configuration / Menu

CARE diagnostica
GLUCOSE /LACTATE
DeviceType: ecoTwenty
Serial number: 00001
-------------------------------------------
System parameter
12.11.2012 08:18
Sensor age : 3 days
-------------------------------------------
Firmware version: V 1.17P
Pump counter : 56,9 ml
Measurements: 52
Calibration: for each
plate
Double measure
Glucose
Min: 2.8 mmol/
Max: 19.4 mmol/l
Lactate:
Min: 1,2 mmol/l
Max: 10,0 mmol/l
Controls and RiliBAK
K1
Glucose LO: 4.6 mmol/l
Glucose UP: 5.7 mmol/l
Lactate LO: 1,6 mmol/l
Lactate UP: 2.0 mmol/l
K2
Glucose LO: 12.4 mmol/l
Glucose UP: 15.5 mmol/l
Lactate LO: 3.0 mmol/l
Lactate UP: 3.7 mmol/l
K3
Glucose LO: 12.4 mmol/l
Glucose UP: 15.5 mmol/l
Lactate LO: 3.0 mmol/l
Lactate UP: 3.7 mmol/l
Serial port: none
Baudrate: 9600
Parameter: 8,N,1
Preamble: STX
Postamble: ETX
IT-Device No.: 1
Method No.: 1
 System Configuration / Menu 33

4.6.4.5. Select language

Here the user can change the language of the system. Currently you can select
between English, German and Russian.

4.6.4.6. Setpoints / Controls

For the quality control of the instruments the user should measure controls daily. In
Germany, the users are obliged under the Guidelines of the Federal Medical Council
for quality assurance of quantitative medical laboratory tests (RiliBÄK) for the
measurement of controls.

The ecomatic and ecoTwenty can manage three different control samples. The
ecobasic manages two different control samples.

In this menu the target values of the controls are adjusted:

34 System Configuration / Menu

The tolerance of the control samples measurement of glucose and lactate are 11%.
For all six controls this tolerance is the same. A control-specific setting is not possible
here.

After entering the target value of the controls, the control limits are calculated
automatically. If the measured controls are out of these limits the instrument will stop
automatically. The message “Control limits” appears in the display.

4.6.5. Device settings

Under the menu item "Device Settings" you will find 15 submenus to adjust the
system parameters of the device.
 System Configuration / Menu 35

4.6.5.1. Set system parameters

Under this submenu you can adjust the system parameter for the device. The
submenu is protected by password. Only in agreement with the technical service of
CARE diagnostica GmbH you get access to this submenu.

4.6.5.2. Fill system

With this function you can start the procedure “Fill system”. After touching the
“START”-button the pump begins to fill the system.

4.6.5.3. Lifter position setup

Under this submenu you can adjust the lifter positions. The submenu is protected by
password. Only in agreement with the technical service of CARE diagnostica GmbH
you get acess to this submenu.

4.6.5.4. Plate position setup

Under this submenu you can adjust the trayposition. The submenu is protected by
password. Only in agreement with the technical service of CARE diagnostic GmbH
you get acess to this submenu.
36 System Configuration / Menu

4.6.5.5. Cup detection setup

With this submenu you can adjust the cup detector sensor.

The standard value depends on the used device type. This value is the threshold
at which the device detects the cup. If not all samples were recognized the
sensitivity must decreased. If empty positions were measured the sensitivity must
increased.

4.6.5.6. Cup detection test

With this submenu you can test the cup detector sensor. By touching the
button you get access to the submenu:
 System Configuration / Menu 37

Now you must insert some cups in several positions of the tray. Touch the “Test” icon
on the appeared display. Now the tray will turn around and every position where a
cup is present the cup will be tapped.
If not all cups will be detected, please decrease the threshold about 10mV by

pressing the -button. After this please repeat the test.

If empty positions will be measured, please increase the threshold about 10mV by

pressing the -button.

If all positions will be detected in the right way you can leave the menu with the Back-
Icon. The now calculated threshold is applied.

4.6.5.7. Show sensor status

Under this submenu you will find all information about the sensors inside the device.
This information is important in case of technical support.

4.6.5.8. Move plate

With this submenu it is possible to test the moving of the tray. With the arrow key you
can select every measuring position on the tray. By touching the “GO” icon the tray is
moved to the selected position.
38 System Configuration / Menu

4.6.5.9. Move lifter

With this submenu you can test the moving of the lifter. With the arrow key you can
select lifter position. By touching the “GO” icon the lifter is moved to the selected
position.
 System Configuration / Menu 39

4.6.5.10. Pump

This submenu is used to check the pump function of the device.

By touching the “ON” icon the device begins to pump. Further you get information
about the steps and the function of the pump sensor.

4.6.5.11. Curve display setup

In this submenu you can select between “Diplay curve” ON and OFF.

Switched ON, you will see the calibration curve/measuring cure in the display during
the measurement.
40 System Configuration / Menu

4.6.5.12. Check pump

Under this submenu you can test the pump function. The submenu is protected by
password. Only in agreement with the technical service of CARE diagnostica GmbH
you get acess to this submenu.

4.6.5.13. Print System Parameters

With this submenu you can print out the settings of the device.

4.6.5.14. Touch calibration

For calibration of the touch screen please follow the messages on the display.

4.6.5.15. USB Memory

To use this menu, a as “hard disk” formatted USB Stick must be inserted slowly into
the USB slot. After plugging in the message “USB device plugged” appears
temporarily on the display.
 System Configuration / Menu 41

For further details of the font-, language- and firmware updates please contact the
technical service of CARE diagnostica GmbH.
Under the submenu “Store to USB…”

all data and all parameter can be exported. By touching the icons a
eco2012-ser_no-date-time-data.csv and eco2012-ser_no-date-time-para.csv
is exported to the USB-Stick.
42 Changing the sensor

5. Changing the sensor

The thick film sensor is a consumable and must be changed from time to time. This
can be necessary when the controls are drifting out of range, or when calibration
voltage is getting too low.

1. Take the new sensor and remove the packaging. Do not touch the enzyme part
of the sensor.

2. Loose the screw on the measuring

chamber with the until the chamber is
completely open.

3. Remember how the old sensor is

installed and remove it.

4. After removal of the old sensor the

device registers the absence of the
sensor. In the display appears the
following message:
 Changing the sensor 43

5. Insert the sensor in the same way. The tab with the green dot should face to the
rear of the unit.

6. Close the measuring chamber by tightening the

screw.

7. The device detects the sensor automatically.

8. In the appeared display the replacing of the

sensor must be confirmed.

The system fills automatically and the running in time begins.

Hint: For an optimal function of the sensor and machine, we recommend a run
in time of 1 hour. If you measure before this, you will have a stronger drift
across the tray. We recommend to change the sensor after the last
measurement of the day to allow for an ideal over night run in.
44 Care and Maintenance

6. Care and Maintenance

The instrument requires no routine maintenance or lubrication. To ensure a long life

for the instrument it should be used in a dry, non-aggressive environment. It is
recommended that the valve system on the aspiration probe and the tubes leading to
the pump be checked or replaced every six months.

6.1. Changing the pumptube

Start with the upper tube and turn the pump anti-
clockwise (the upper tube is marked).

Disconnect the pump tube from the other tubing.

Connect the new tube and then insert it and turn
the pump anti-clockwise (be sure not to trap the
tube).

Never attempt to loosen the 2 screws on the

cross. This will affect the measuring results of
the device.
 Care and Maintenance 45

6.2. Replacing the exchanger

Remove the exchanger tube.

Remove the two Philipps head screws from the

cover.

Remove the needle tube (note how far the tube

is on the needle).
Lift the needle until it is out of the exchanger.
Remove the old exchanger.
Install the new exchanger in the reverse order.
46 Care and Maintenance

6.3. General hints

6.3.1. Touchscreen
To clean the touch screen, use ethanol. Do not use acids, alkaline cleaning fluids,
and no sharp objects. For the operation of the touch screen do not use sharp objects,
use your finger or the touch pen.
You can find the touch pen in the compartment on the left side.

6.3.2. Labeling of the sample cups

The sample cups (REF 866 620) have one side roughened surface for writing. Under
no circumstances the cups must be labeled on the top lid. A label on the lid of the
sample cups leads to pigment deposits in the tubing system and measuring chamber,
which inevitably leads to a defect of the device.

6.3.3. Storage of the device when it is not used

In order to keep the device ready for measurement, it should not be totally switched
off, but kept in standby mode. Switching the device off completely will result in a
deterioration of the sensor, and eventually to its defect.
If the device is not used for a prolonged period (> 3 weeks), it is advisable to drain
the tubing system. It should proceed as follows:

1. Unscrew the lid of the System solution and put it aside (suck air).
2. Execute the function “Settings” > “Device settings” > “Fill System” > “START”
3. Repeat this function one more time.

After this the tubing is empty. In addition, the sensor from the cell should be removed
(please note a new sensor will be needed when you put the device back into
operation) and the pump tube hung out.

6.3.4. Shipment of the device

Should the unit be sent, prior to the dispatch necessarily empty the waste bottle and
the System solution bottle and remove all other reagents and samples.
 Appendix 47

7. Appendix

7.1. Used Symbols

The following symbols are used on the reagents of the instruments ff

f the ecoSeries:

reference-number
reference
batch code
use by
manufacturer
In Vitro Diagnostic Medical Device
temperature limitation (Store at)
consider the operation manual

Contents
this product fulfils the requirements of the
European Directive 98/79 EC for in vitro
diagnostic medical devices
do not use twice

7.2. Hotline
Should there be any technical problems, please feel free to use our hotline for advice
or assistance:
Fax: +49 281 / 94 40 4-10
E-Mail: [email protected]

Post: CARE diagnostica Laborreagenzien GmbH

Weseler Str. 110
46562 Voerde
Germany
48 Appendix

7.3. EC-Declaration of conformity