Saladax MyCare Insite User manual

User Manual
PI MCI-EUR-ML-PKG Rev 01
EN, DE, ES, FR, NL
2023-07-26
EC REF
EMERGO EUROPE
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
IVD
Saladax Biomedical, Inc.
116 Research Dr.
Bethlehem, PA 18015
USA

INTENDED PURPOSE
The MyCare Insite is intended as an automated general-purpose laboratory instrument for the quantitative
determination of clinical wet chemistry parameters. The Analyser is intended to be used solely in conjunction with
MyCare Insite Test kits and is designed to be used either in a clinical laboratory or in a near-patient setting by
health-care professionals.
PRINCIPLE OF OPERATION
The MyCare Insite is used to quantify an analyte concentration in samples with an optical absorbance measurement.
To perform a test the MyCare Insite Analyser is loaded with a test cartridge containing reagents and the sample to
be tested.
The Analyser is equipped with an RFID card-reader module. RFID cards are necessary for performing any testing
procedures. They are included in the test kits and contain all the specic steps for the various tests, the lot data,
as well as the calibration data. The Analyser performs the tests automatically according to the information on the
RFID card. The test measured is dictated by the RFID card placed on the Analyser. RFID cards and tests are
color-coded. Numerous types of tests can be performed automatically.
The sample and the reagents are automatically mixed within the Analyser. The photometer unit performs the
analysis with a light emitting diode (LED). The absorption of light rays is determined during this process and the
measured values are then automatically converted into the test result using mathematical methods.
The test cartridge design is self-contained so that the Analyser has no contact with reagent or sample.
The result is displayed on the Touch Screen. Optionally, results can be exported to an external computer or an
HIS/LIS and can also be printed to an external printer.
After the test process the door opens automatically and the test cartridge can be removed and discarded. After
conrming the result on the Touch Screen and closing the door, the Insite is ready to perform the next analysis.
With LED technology the Insite requires no maintenance.
SYMBOLS
Consult Instructions for Use Electronic Equipment: Do not dispose with
household waste
IVD in vitro Diagnostic Device Manufacturer
Temperature Limitation SN Serial number
REF Catalog Number Caution
Electrical Symbol EC REF Authorized Representative in the European
Community
Near Patient Testing Indicates conformity with the provisions of the
applicable EU directives and/or regulations
Date of Manufacture Relative humidity limitation
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ANALYSER COMPONENTS
The MyCare Insite consists of the MyCare Insite Analyser laboratory photometer and the MyCare Insite Touch
Screen. The Insite package contains:
• User Manual
• MyCare Insite Analyser
• Power adapter
• Power cable
• Test Rack
• USB cable
• Touch Screen
• Touch Screen Stand
• Touch Screen Mounting instructions
Before rst use remove the transport lock from the door of the Analyser.
Note: Keep both the transport lock and the original packaging. In case of a defect, the device must
be returned in the original packaging with the transport lock installed to prevent damage in transport.
The Insite Technical Guide and videos for unpacking and setting up the Insite are at MyCareInsite.com.
With WiFi Connectivity tap on the Main Menu to access the information.
WARNINGS AND PRECAUTIONS
• For in vitro Diagnostic Use Only
• The Analyser performs self checks during measurements. Any electro-mechanical error will stop a result
from being generated. If an error message appears on the screen, please consult the “ERROR MESSAGES
AND POSSIBLE CAUSES” on page 10. Repeat the test.
• The door prevents ambient light, dust, dirt, and humidity from entering the Analyser during the testing process.
• Remove the test cartridge from the Analyser after every test. Dispose of the test cartridge appropriately.
• Make sure the door is closed whenever the Analyser is not in use.
• Do not attempt to open the Analyser door manually.
• Use only your ngertips to operate the Touch Screen! Do not use pens or other objects that may scratch or
damage the screen.
• Do not use liquid cleaners on the Analyser or Touch Screen. Use a lint-free, slightly damp cloth only.
• Connect optional equipment only when the Analyser is unplugged. Please note that attaching optional
equipment (e.g., a printer) can increase the amount of leakage current.
• Use ONLY manufacturer-approved tests. Otherwise, serious damage to the Analyser and/or inaccurate test
results may occur.
• To ensure samples are correctly identied run only one sample at a time.
• To ensure safe operation, always use the MyCare Insite according to the instructions in the package insert.
• Avoid electromagnetic radiation and electrostatic discharge.
• Prevent physical access by unauthorized users
• Enable screen lock setting “Password” on the Touch Screen.
• Any serious incident that occurs in relation to the MyCare Insite shall be reported to the manufacturer and
the competent authority of the Member State in which the user and/or the patient is established.
• Residual Risks: User error may cause display of a wrong measurement result, delayed result, no result; and
unauthorized access to information.
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DESCRIPTION OF THE MYCARE INSITE
This section introduces the general characteristics of the MyCare Insite Analyser and Touch Screen.
Touch Screen Lock Port
Bluetooth ON/OFF Switch
left: Bluetooth OFF)
USB Port (type A) for connecting
Touch Screen
RS-232 Port for connecting a
printer, a barcode reader or a PC
(for data transfer)
Power Supply Port
USB Port (type B) for connecting
a PC (for data transfer)
MyCare Insite Analyser Interfaces
MyCare Analyser Back
RFID Card Well – The RFID card is
placed here.
Indicator Lights – There are 3 LEDs
on the front of the Analyser.
Door – When the door opens the test
cartridge (Cuvette with Reagent Cap)
can be inserted or removed from the
inner Chamber.
Note: do not attempt to open the
door manually.
Touch Screen – User interface
to operate the Analyser &
process the results.
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Indicator Lights
MyCare Insite Analyser Front
LEDs on the MyCare Insite Analyser
This green LED indicates the Analyser status
Flashing: the Analyser is warming up and testing cannot be
started yet. (Note: warm-up takes approximately 10 min.)
On (green): the Analyser is warmed up and ready for use
Off: the Analyser is not plugged in
This blue LED indicates the Touch Screen connection status
On (blue): connection with the Touch Screen is established
Off: the Touch Screen is not connected
This blue LED indicates Bluetooth connection status
On (blue): connection with the Touch Screen is established
Flashing: Analyser Bluetooth is activated but no Touch
Screen is connected via Bluetooth
Off: Bluetooth is switched off
Note: Use of the USB cable connection is recommended to keep
the Touch Screen powered.
Operating and Storage Conditions
Operating conditions:
• 20 - 28°C; relative humidity: 10 – 85%
• A dry, clean, level surface with at least 10 cm of clearance on each side
Storage/Transport:
• 0 - 50°C; relative humidity: 5 – 85%
• Always use the transport lock when transporting the analyser or damage may result
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SETTING UP THE MYCARE INSITE ANALYSER AND TOUCH SCREEN
AVOID
• Condensing humidity and water
• Heat and large temperature uctuations
• Electromagnetic radiation
• Electrostatic discharge
• Vibrations (e.g. from centrifuges and dishwashers)
• Direct sunlight
Place the Analyser on a dry, clean, stable, and level surface.
Make sure the Analyser has at least 10 cm of table surface and clearance on each side, and that the Analyser can
be easily disconnected from the power source. Allow the Analyser to acclimate to the ambient room temperature
before operation.
Plug the Power Adapter (AC adapter plug) into the Analyser and the Power Cable into the wall socket.
The MyCare Insite is operated with a Touch Screen.
To ensure that the Analyser is properly grounded, use a 3-pole power outlet that includes neutral, hot, and ground
sockets. The MyCare Insite must be connected to a power outlet with a 3-pole plug.
A certied electrician can conrm that the grounding meets requirements.
Ensure the Analyser is plugged in. Connect the Touch Screen to the USB port of the Analyser and then turn on the
Touch Screen.
The launch screen appears by pressing
the Touch Screen home button or when
the Touch Screen is not connected to
the Analyser.
Touch the MyCare Insite logo to start
the MyCare Insite application.
Touch Browser to open the Android web
browser.
Touch Settings to open the Android
settings menu.
The connection screen appears when the Touch
Screen is connected to the Analyser.
Tap Next to continue.
The MyCare Insite application starts and the main
menu appears.
Note: while the MyCare Insite is warming-up (indicated
by the ashing green LED on the front, see page 5) the
“Measurement” button is grey and inactive.
The MyCare Insite Launch Screen
1. Connection Screen 2. Main Menu
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How to Wake-Up the MyCare Insite or Switch It OFF
When the Touch Screen displays the main menu, the “power save” function dims the screen. Pressing the lock
switch will re-illuminate the display to its customary level of brightness. It is not necessary to switch the MyCare
Insite off every day. Turning off the device completely can only be done by disconnecting it from the power supply.
Materials Provided:
REF MCI-EUR – MyCare Insite (consisting of MyCare Insite Analyser laboratory photometer and the
MyCare Insite Touch Screen)
Materials Required – Provided Separately:
MyCare Insite Tests and Controls
Materials Not Provided – Optional:
• An external printer – Seiko Label Printer 650SE, serial 100 – 240 VAC
• An external barcode scanner - Honeywell Voyager 1200g, 3.8~13.2 cm (5 mils), 0.09 mm (3.5 mils),
100 – 240 VAC, for optional entry of patient or operator ID
• A PC – for the transfer of test data into a hospital or laboratory Information system (HIS/LIS)
ANALYSING A PATIENT SAMPLE OR CONTROL
Please refer to package insert provided for the MyCare Insite Test at MyCareInsite.com
and follow all instructions including:
• The proper temperature of a test before it can be used
• The exact volume of sample
• The proper storage of the tests
• Be sure to handle the tests according to the instructions in the package inserts.
• Be sure the test cartridge (Cuvette with Reagent Cap) is properly sealed before inserting into the Analyser.
• Be sure the test cartridge (Cuvette with Reagent Cap) is fully inserted into the Analyser Chamber.
• Use ONLY manufacturer-approved tests. Otherwise, serious damage to the Analyser and/or inaccurate test
results may occur.
• Do not attempt to open the door manually – open the door from the Service/User Service Menu.
• A quality control program should be performed on a regular basis to verify the MyCare Insite is working properly
and providing reliable results.
• Data integrity can only be assured when controls and GCLP practices are used routinely.
• The frequency of performing QC shall comply with local, state and/or national regulations.
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3. Test Screen
The MyCare Insite displays the test name and
number of tests remaining on the RFID card.
• Ensure the test name is the test being run
• Ensure the RFID and Test components have the
same color coding
Touch to proceed.
Touch to return to the main menu.
4. Input Menu
Select the desired input eld (e.g. “Name”); the Touch
Screen keyboard appears. Enter the information and
conrm with “Done”. Next, tap and select an
entry from the drop-down menu. Touch to conrm
the input or to exit to the main menu.
5. Insert Cartridge and
Close Door
6. End of Measurement
The door opens automatically. Insert the cartridge
(Cuvette with Reagent Cap) into the Analyser and
close the door. The test starts automatically.
At the end of the measurement the door opens and
the result appears on the Touch Screen. Remove the
test cartridge and close the door for the next analysis.
1. RFID Card Placement 2. Main Menu
Take the provided RFID card out of the test kit
and place it on the RFID card well on top of the
Analyser.
To start a measurement, select in the Main
Menu. The MyCare Insite automatically reads the
RFID card and the Test Screen appears.
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VIEWING AND PROCESSING TEST RESULTS
After processing a test, the result screen appears on the Touch Screen:
All test results are stored on the Touch Screen. They can be accessed as follows:
The test result is displayed on the Touch Screen.
Use and to scroll back and forth within the results.
Tap to export to a HIS/LIS or PC or send as email.
Tap to print.
Tap to open the photometric data curve.
Tap to synchronize the result with MyCOS (MyCare
Online Services) server.
Tap to delete the result.
Tap to exit to the main menu.
Tap in the main menu to open the Result List.
The stored results can be browsed by swiping up and down.
Tap a result to open the result screen (see above), to
return to the result list from a result screen press the
Return Arrow .
Tap to open the lter options.
Tap to export or mail.
Tap to print, mail, or export.
Tap to synchronize results.
Results can be ltered by date, test, and Patient ID.
Tap to set the desired start date,
and to set the desired end date.
Tap to select a test name in the drop-
down menu (e.g., CLZ).
Tap to lter by patient ID.
1. Result Screen
1. Main Menu
2. Result List Screen
2.1 Filter Options
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Error message Cause Correction
Invalid card
A wrong, defective, or expired RFID card has
been used.
Incompatible application.
A defective RFID module.
Use a new test kit RFID card.
Update Insite application.
Please contact your Ofcial Saladax Distributor.
Tests expired The test has passed its expiration date. Use a new test that has not expired.
Wrong date set The date set on the Touch Screen is wrong. Change the date to “today” as described in the
Touch Screen Starter Manual.
Door blocked
The test Cartridge is blocking the door because
the Cartridge has not been inserted completely
or the Reagent Cap does not close the Cuvette
rmly enough.
Reposition the test cartridge or tighten the
Reagent Cap on top of the Cuvette.
Please contact your Ofcial Saladax Distributor if
the door fails to open at the end of a run.
Wrong cap
Missing cap
Missing cartridge
The wrong Reagent Cap is being used, or the
Reagent Cap is missing, or the Cartridge is
missing, or an already used Cartridge is inserted.
Use the correct Cuvette and Reagent Cap.
Bolt blocked
The test Cuvette blocks the bolt (that locks the
Chamber) because the wrong Reagent Cap is
being used.
Use the correct Cuvette and Reagent Cap.
Measurement
overow
The photometric measurement value lies outside
the measuring range
(e.g. a cold Cuvette and Reagent Cap have been
used).
Repeat the test using a new Cuvette and
Reagent Cap.
Blank error The photometric measurement value is outside
the measuring range (without the cartridge). Repeat the test after restarting the Analyser.
Temperature error The temperature is outside the range. Repeat the test after restarting the Analyser.
Mix error Analyser fails to perform test due to possible
hardware error. Please contact your Ofcial Saladax Distributor.
Sample volume
error
The rst measurement (before the reaction start)
is above the specied limit.
Repeat the test using a new Cuvette and
Reagent Cap. Ensure the Cuvette and Reagent
Cap have warmed up for at least 10 minutes and
there is no condensation on the Cuvette. In the
case of condensation wipe the Cuvette with a lint
free cloth.
Cuvette
temperature error
The Cuvette’s temperature is too low for a proper
test.
Repeat the test and refer to the package insert
for proper Cuvette use.
Reaction error
The Cuvette may have been inserted without a
Reagent Cap or there was another issue with the
Reagent Cap.
Repeat the test using a new Cuvette and
Reagent Cap.
ERROR MESSAGES AND POSSIBLE CAUSES
Door opening during a measurement indicates an error. Consult the following error messages.
If an error occurs during the measurement, the test must be repeated.
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