Saladax MyCare Insite User manual

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User Manual
Saladax Biomedical, Inc.
116 Research Dr.
Bethlehem, PA 18015 USA
Tel: [phone]
Fax: [phone]
MyCareInsite.com
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The following symbols and abbreviations are used in the product labeling and instructions for the
MyCare Insite laboratory photometer.
Table 1: Product Labelling and User Manual Symbols
Symbols Explanation
Conformity marking according to the directive 2014/30/EU of the European
Parliament and of the European Council of 26 February 2014 on the
harmonization of the laws of the Member States relating to electromagnetic
compatibility
Authorized Representative in the European Community
Catalog number
Batch Code
Serial number
Bluetooth
Connection
Power Supply / Device Status
Use by
Temperature limit
Humidity Limitation
Consult Instructions for Use
Caution
Contains sufficient for <n> tests
Manufacturer
Symbols & Abbreviations

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Table 1 continued: Product Labelling and User Manual Symbols
Symbols Explanation
Production date
Mark of electrical and electronic equipment in accordance with Article 14(4) of
Directive 2012/19/EU (WEEE)
Bluetooth
Connection
Power Supply / Device Readiness
Electrical Symbol
Table 2: Abbreviations and Definitions in the User Manual
Abbreviations and Definitions Explanation
Operator's action
Test Cartridge
Cuvette sealed with Sample Collector containing a sample
LED
Light Emitting Diode
PC
Personal Computer
ID
Identification
HIS / LIS
Hospital Information System / Laboratory Information System
AC
Alternating Current
DC
Direct Current
RFID
Radio Frequency Identification

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Symbols & Abbreviations.........................................................................................................2
Table of Contents .................................................................................................................... 4
Introduction...............................................................................................................................7
Welcome ...................................................................................................................................................7
Serial number ...........................................................................................................................................7
Firmware versions....................................................................................................................................7
Notes.........................................................................................................................................................7
Intended Use of the MyCare Insite......................................................................................................... 8
About this User Manual........................................................................................................................... 8
System Description ..................................................................................................................9
Description of the MyCare Insite............................................................................................................ 9
MyCare Insite Analyser Interfaces ......................................................................................................... 9
Indicator lights........................................................................................................................................10
How to Handle the MyCare Insite Analyser Laboratory Photometer..................................................10
How the MyCare Insite Analyser Laboratory Photometer Works .......................................................10
Manufacturer’s Calibration.................................................................................................................... 11
Pictograms / Button Symbols .............................................................................................. 12
Touch Screen Symbols and their Functions.........................................................................................12
Getting Started ....................................................................................................................... 13
Inspecting the Package Contents .........................................................................................................13
MyCare Insite Packaging .......................................................................................................................13
The Proper Placement of the MyCare Insite Analyser Laboratory Photometer.................................14
Transport lock ........................................................................................................................................14
Connecting the Power Supply ...............................................................................................................14
Proper Grounding...................................................................................................................................15
The Touch Screen ..................................................................................................................................16
Starting & Operating the Touch Screen................................................................................................16
The MyCare Insite Launch Screen ........................................................................................................16
Table of Contents

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Changing the Language of the MyCare Insite Application...................................................................17
How to Switch the MyCare Insite Laboatory Photometer ON .............................................................17
The Automatic Start-Up and Warm-Up Processes ..............................................................................18
Configuring the MyCare Insite..............................................................................................19
Setting Normal Values/Range and Limits ............................................................................................19
Setting units ..........................................................................................................................................20
Configuring Inputs (Sex, Sample Type, Operator).............................................................................. 20
Configuring Interfaces ...........................................................................................................................21
Optional Equipment............................................................................................................... 22
Printer, Barcode Scanner or PC ........................................................................................................... 22
Using a Barcode Scanner to Scan Patient ID and/or Operator Information ..................................... 23
How to Wake-Up the My Care Insite or Switch It OFF ......................................................................... 23
Test Procedures ..................................................................................................................... 24
Overview of the Testing and Measuring Procedures .......................................................................... 24
Operating Safety Precautions .............................................................................................................. 25
Testing a Patient Sample...................................................................................................................... 26
Viewing and Processing Test Results .................................................................................................. 28
MyCare Online Services (MyCOS) ....................................................................................... 29
MyCOS Synchronization....................................................................................................................... 30
Synchronize all test results...................................................................................................................30
MyCare Online Services Registration................................................................................................ 32
MyCOS Web Access.............................................................................................................................. 33
Recommended web-browsers........................................................................................................... 33
Login Sceen ........................................................................................................................................ 34
Result List ........................................................................................................................................... 34
Export of Measurement Result List................................................................................................... 35
Printing of Measurement Result list .................................................................................................. 36
Header User Interface Elements ....................................................................................................... 36

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Quality Control (QC)...............................................................................................................37
QC materials.......................................................................................................................................... 37
Handling QC Control Materials............................................................................................................. 37
Frequency of QC Testing ...................................................................................................................... 38
Correlation.............................................................................................................................. 39
Performing a Parameter Correlation Adjustment............................................................................... 39
Cleaning Instructions ............................................................................................................ 40
Cleaning the Touch Screen display......................................................................................................40
Cleaning the Door & Chamber..............................................................................................................40
Cleaning the Exterior.............................................................................................................................40
External Interface Description..............................................................................................41
Serial Interface .......................................................................................................................................41
USB Interface .........................................................................................................................................41
Error Information and Troubleshooting.............................................................................. 42
Error Messages and Possible Causes .................................................................................................. 42
Service information............................................................................................................................... 43
Technical Specifications....................................................................................................... 44
MyCare Insite Analyser ......................................................................................................................... 44
Power supply ......................................................................................................................................... 44
Options................................................................................................................................................... 44
Shutdown and Waste Management..................................................................................... 45
Manufacturer Information .................................................................................................... 46

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Welcome
Congratulations on the purchase of your MyCare Insite.
Upon arrival of your MyCare Insite Analyser, we recommend that the serial number along with the
firmware version be recorded in the table provided below. The additional rows in the table are for any
firmware upgrades performed on your Analyzer. The recorded information is of value if technical
support Is needed.
Serial number
For serial number (SN), see label on the back side of the analyzer or on the box
Firmware versions
Date
Firmware version*
Upon receipt
1. Firmware upgrade
2. Firmware upgrade
3. Firmware upgrade
* see “Connection Screen”, page16
Notes
Technical Support:
Visit MyCareInsite.com
Email: [e-mail]
Introduction

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Intended Use of the MyCare Insite
The MyCare Insite, consisting of the MyCare Insite Analyser laboratory photometer and the MyCare
Insite Touch Screen, is intended as a general purpose laboratory instrument for the quantitative
determination of clinical wet chemistry parameters.
The Insite is highly compact and is designed as a point of care measuring device for the MyCare Insite
Tests.
About this User Manual
This user manual will guide you through the installation, operation and maintenance of your MyCare
Insite. The user manual also explains how the photometer works, describes the quality assurance
system and assists you in troubleshooting any errors or problems. When not used according to the
User Manual the MyCare Insite may not peform properly or be damaged.
We recommend that you familiarize yourself with these instructions before operating the MyCare
Insite. Some of the information in this user manual is marked with the following symbols:
O
perator's action
Warnings and precautions; see
accompanying documents
Refer to the user manual
or test package insert and follow the instructions

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Description of the MyCare Insite
This section introduces the general characteristics of the MyCare Insite Analyser and Touch Screen.
RFID Card Well The RFID card is placed here
Indicator Lights
There are 3 LEDs on the front
of the Analyser.
For a detailed description
refer to page 10.
Door
The test cartridge (Cuvette
with Sample Collector) is
inserted and removed from
the Chamber when the door
opens.
Note:
do not attempt to
open the door manually.
Touch Screen
User interface to operate the
Analyser & process the
results.
MyCare Insite Analyser Interfaces
Analyser Back
Power Supply Port
USB Port (type B)
for connecting
a PC (for data transfer)
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)
Do not use liquid cleaners on the Analyser or Touch Screen. Use a lint-free, slightly damp
cloth only
.
Do not attempt to open the Analyser door manually.
System Description

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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 Touch Screen connection status
On
(blue)
:
connection with Touch Screen is established
Off:
the Touch Screen is not connected
This blue LED indicates
Bluetooth connection status
On
(blue)
:
connection with 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 t
o keep
the T
ouch Screen powered.
How to Handle the MyCare Insite Analyser Laboratory Photometer
The Analyser is operated solely by means of the Touch Screen. All the basic operating steps are
displayed as symbols in
Table 1 (page 2), and Table 2: Abbreviations and Definitions in the User
Manual (page 3).
To activate a symbol tap it with a finger.
In order to perform a test, the RFID card enclosed in the test kit must first be placed on the analyser.
This card contains all the data needed to perform the tests. No analysis can be started without the RFID
test card.
The door opens automatically when a test is initiated by pressing the button. After entering all
the requested data on the Touch Screen and inserting the test cartridge (Cuvette closed with Sample
Collector) into the Chamber, close the door. The test starts automatically. After the test is completed,
the door opens automatically and the test cartridge is removed.
The door prevents ambient light, dust, dirt and humidity from entering the Analyser during the testing
process, and when the Analyser is not in use.
Please make sure the door is closed whenever the Analyser is not in use.
How the MyCare Insite Analyser Laboratory Photometer Works
The MyCare Insite Analyser laboratory photometer is a measuring device. To perform a test, the
MyCare Insite Analyser is loaded with a test cartridge (Cuvette with Sample Collector containing a
sample). The Analyser automatically processes the test when the door is closed. The latest LED
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technology means maintenance-free operation.
The Analyser is equipped with an RFID card-reader module. RFID cards are necessary for performing
all testing; they are included in the MyCare Insite Test kits and are specific to the kit. The Cuvette,
Sample Collector and RFID card are color coded. Check that the RFID card, Cuvette, and Sample
Collector are of the same color. RFID cards contain all the specific steps necessary for the Analyser to
perform tests, as well as lot data, and calibration data. The Analyser performs all the tests automatically
according to the information on the RFID card.
Test components are incubated and combined by the Analyser to generate a reaction that absorbs light
according to the amount of drug in the sample. The photometer unit performs the analysis with a light
diode. The absorption of light rays is measured during this process and the measured value is then
mathmatically converted into a test result. 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 out using an
external printer.
After the test process is complete, the door opens automatically, and the test cartridge (Cuvette with
Sample Collector) can be removed and discarded. After confirming the result on the Touch Screen and
closing the Analyser door, the device is ready to perform the next test.
Manufacturer’s Calibration
The MyCare Insite Analyser is manufactured according to the highest quality standards to produce safe
and accurate test results. Every Analyser is inspected and calibrated during the manufacturing
process.

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Touch Screen Symbols and Their Functions
Table 3: MyCare Insite Touch Screen symbols
Tap a symbol on the Touch Screen to activate the described function.
Symbol Name Function
MyCare Insite App Starts the MyCare Insite app
Browser Opens the Web Browser on the Touch Screen
Android Settings Opens the Android settings menu
Return arrow Cancels an input OR returns to the previous screen or
menu
Return to main menu Returns directly to the main menu
Measurement Opens the menu for test data entries
Results Opens the result list screen
MyCare Insite Settings Opens the Settings menu
Edit Opens an entry or value so it can be edited
Confirm Confirms the input
Abort to main menu Cancels an action and returns to the main menu
Start analysis Starts the test process
Print Opens the print / export / mail dialogue
Filter Opens the Filter Options
Transmit Opens the Export dialogue
Analyser Data Button Displays the photometric data of a test result
Page forward Displays the next page
Page backward Displays the previous page
Recycle bin Opens the delete dialogue
Synchronize Synchronises result(s) and Analyser status with the
MyCare Insite servers
Pictograms / Button Symbols

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Inspecting the Package Contents
For a quick overview of this section watch the MyCare Insite Getting Started Video at
MyCareInsite.com.
When unpacking the MyCare Insite, check the contents against the list below and examine the
components for signs of shipping damage.
The MyCare Insite package contains:
-Touch Screen
-Touch Screen Starter Manual
-MyCare Insite Quick Reference
-MyCare Insite Analyser
-Power Adapter
-Power Cable
-Test Rack
-Touch Screen Stand
-Touch Screen Mounting Directions
If any part of the package is missing or damaged, please report this immediately to your Official Saladax
Distriubtor. Keep the original packaging for transport and shipping.
MyCare Insite Packaging
If the Analyzer must be returned to the manufacturer or before transport, please repack the Analyser
contents in the original packaging according to the following illustration:
Getting Started
1. Touch Screen Stand
2.
Test Rack
3.
Power Cable
4.
Power Adapter
5.
Analyser
1
2
3
4
5
Note: please remember to reinsert the transport lock (p. 11) into the
Analyser door before repacking
WARNING: Incorrect packing and/or inappropriate packaging can
cause severe damage to the Analyser

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The Proper Placement of the MyCare Insite Analyser Laboratory
Photometer
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 operat
ion.
The Analyser can be damaged by:
Condensing humidity and water
Heat and large temperature fluctuations
Direct sunlight
Vibrations (e.g. from centrifuges and dishwashers)
Electromagnetic radiation
E
lectrostatic discharge
Transport lock
Before first use, remove the transport lock by pulling it up from the Chamber of the
Analyser.
Note: keep both the transport lock and the original packaging in case of a the Analyser
must be re-packaged for transport. Transporting in the original packaging with the
transport lock installed will prevent damage in transport.
Connecting the Power Supply
MyCare Insite Analyser Interfaces
Power Supply Port
USB Port (type B)
for connect-
ing a PC (for data transfer)
Touch Screen-Lock Port
Bluetooth ON/OFF
Switch
left: Bluetooth OFF)
USB Port
(type A)
for
connecting a Touch Screen
RS 232 Port
for connecting a
printer, a barcode reader or a PC
(for data transfer)
-Connect the power cable to the power adapter.
-
Insert the plug from the power adapter into the power supply port on the back of the
Analyser.
-
Plug the power cable into the wall socket.

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Always connect to the proper supply voltage. The power adapter voltage must comply
with the regulations cited in the technical specifications on page 44. Ensure the electrical
ground is correctly installed (page 15). Use only the power adapter provided to operate
the Analyser.
Proper Grounding
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.
Illustration of different power outlets with grounding
A certified electrician can confirm that the grounding meets requirements.
EMC Related Caution:
This equipment and/or system complies with the International Standard EN61326-1 for
electromagnetic compatibility for electrical equipment and/or system for measurement, control and
laboratory use. However, an electromagnetic environment that exceeds the limits or levels stipulated
in EN61326-1, can cause harmful interference to the equipment and/or device or cause the equipment
and/or system to fail to perform its intended function or degrade its intended performance. Therefore,
during the operation of the equipment and/or device, if there is any undesired deviation from its
intended operational performance, the electromagnetic interference must be identified and resolved
before continuing to use the equipment and/or device. The following describes some common
interference sources and remedial actions:
1. Strong electromagnetic interference from a nearby emitter source such as an authorised
radio station or cellular devices:
Install the equipment and/or system at another location if it is interfered with by an emitter
source such as an authorised radio station. Keep the emitter source such as cellular
devices away from the equipment and/or system.
2. Radio-frequency interference from other equipment through the AC power supply of the
equipment and/or system:
Identify the cause of this interference and if possible remove this interference source.
3. Effect of direct or indirect electrostatic discharge:
Make sure all users and patients in contact with the equipment and / or system are free
from direct or indirect electrostatic energy before using it. A humid room can help reduce
this problem.

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4. Electromagnetic interference with any radio wave receiver such as radio or television:
If the equipment and / or system interferes with any radio wave receiver, locate the
equipment and/or system as far as possible from the radio wave receiver.
If the above suggested remedial actions do not solve the problem, consult your Distributor for
additional suggestions.
The Touch Screen
The MyCare Insite Analyser is operated with a Touch Screen.
Insure the Analyser is plugged in. Connect the Touch Screen to the USB port (see page 9) of the
Analyser and then turn on the Touch Screen.
An independent Touch Screen manual is included with the Touch Screen. It describes in detail the use
of the Touch Screen, how to manage settings and establish a Bluetooth or USB connection between
the Analyser and the Touch Screen.
Starting & Operating the Touch Screen
1. Connection Screen
2. Main Menu
The connection screen appears when the Touch
Screen is connected to the MyCare Insite
Analyser. The serial number, firmware version
and wavelengths are displayed.
Tap
Next to continue.
The MyCare Insite application starts and the main
menu appears.
Note:
while the MyCare Insite Analyser is warming
up (indicated by the flashing green LED on the
front, see page 10) the “Measurement” button is
grey and inactive.
The MyCare Insite Launch Screen
Launch Screen
The Launch Screen is shown when the Touch
Screen is not connected to the Analyser or by
pressing the Touch Screen home button.
Tap Browser to open the Android web browser.
Touch the MyCare Insite Logo to start the MyCare
Insite app.
Touch
Settings to open the Android setting menu.

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Changing the Language of the MyCare Insite Application
The application language is automatically set to the language of the Touch Screen operating system. It
can be changed by pressing the home button on the Touch Screen (the launch screen appears), then
pressing to open the settings. Swipe down and select
Advanced settings, then Language and
input
, then Language & region, then Language, and choose a language. Press the home button to return
to the launch screen.
Note: the MyCare Insite application supports several languages. If you choose a language in the system
settings that is not supported by the MyCare Insite application, English will be used.
How to Switch the MyCare Insite Laboatory Photometer ON
The analyser is switched on by plugging the power cable into the socket. This launches the
analyser
's automatic start-up and warm-
up processes. Please wait for these to be completed
(approximately 1
0 minutes).
When operating the Analyser:
The door protects the Analyser Chamber from dust, dirt and humidity. Empty the chamber
after every
test, and keep it closed when the Analyser is not in use.
The door opens automatically. Do no
t attempt to open the door manually!
If an error message appea
rs during an analysis, please consult the
“
Error information and troubleshooting” section on page 42.

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The Automatic Start-Up and Warm-Up Processes
1. Warm-up menu
2. Main Menu
The automatic start-up procedure (indicated by the flashing green LED) starts as soon as the Analyser
is connected to the power supply. Izt takes approximately 10 minutes for the Analyser to warm up to
its proper working temperature. In colder environments it may take longer for Analyser to reach
operating temperature.
As soon as the initialization of the optical unit is completed, the button turns from gray
(locked) to blue and may be used. The Analyser is now operational.

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You can configure your MyCare Insite laboratory photometer according to your needs before using it.
To access the settings menu follow these steps:
1. Start-up menu
2. Settings menu
Tap
to open the Settings
menu.
Tap the setting you want to
configure. Swipe down to view
all available options.
The following descriptions are examples. The configuration of the MyCare Insite may vary
depending on the tests used.
Note:
The Normal values/Range, units and sample types for a test can only be displayed if
the
RFID card
for the test has been placed on the Analyser and read.
Setting Normal Values/Range and Limits
1. Settings menu
2. Normal values/limits menu, e.g.
CLZ
Tap Normal Values to open the
Normal values / Limits menu.
To change a limit, tap the value and
change it using the Touch Screen
keyboard that appears.
To change the test for which the
normal values are displayed, tap
and select a test from the
drop-down menu.
Configuring the MyCare Insite

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Setting Units
1. Settings menu
2. Unit selection menu
Tap Units to open the Unit
selection menu.
If alternate units are available,
tap and select a unit in the
drop-down menu. Confirm the
change(s) with .
Configuring Inputs (Sex, Sample Type, Operator)
1. Settings menu
2. Input menu
3.1 Default sex menu
Tap Input to open the Input menu.
Tap a parameter and the
respective menu will open. The
following descriptions are
provided in the order of the
parameters in the Input menu.
Tapping opens a drop-down
menu. Select which gender is to be
used as the standard default.
Last used means that the gender
last used will always be selected.
Control may be selected when a
control is tested.
3.2 Sample Type menu
3.3 Operator menu
Tap and a drop-down menu
opens, select which type of
sample should be selected by
default. Last used
means the
sample type last used will be
selected. Confirm with .
Press to cancel.
Enable the operator mode by
tapping the button. To create a
new operator, type the name in the
box blank and then tap .
To delete an operator, tap
and select a name in the drop
down menu, then tap .