Saladax MyCare Insite User manual

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USER MANUAL
Saladax Biomedical
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
Symbols & Abbreviations
Symbols & Abbreviations
Symbols & Abbreviations
Symbols & Abbreviations
Symbols & Abbreviations
Symbols & Abbreviations
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)
Electrical Symbol
Table 2: Abbreviations and Definitions in the User Manual
Abbreviations and Definitions Explanation
Operator's action
Test Cartridge
Cuvette containing a sample and sealed with Reagent Cap
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............................................................................................................................................... 6
Welcome
.....................................................................................................................................................6
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 .........................................................11
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
The MyCare Insite Launch Screen .......................................................................................................... 16
Starting & Operating the Touch Screen ................................................................................................. 17
Changing the Language of the MyCare Insite Application .................................................................... 17
How to Switch the MyCare Insite Laboratory Photometer ON ............................................................ 17
The Automatic Start-Up and Warm-Up Processes ............................................................................... 18
Configuring the MyCare Insite ...............................................................................................................19
Setting Normal Values and Limits
.......................................................................................................... 19
Setting Units ............................................................................................................................................ 20
Configuring Inputs (Sex, Sample Type, Hematocrit, Operator) ......................................................... 20
Configuring Printer ................................................................................................................................... 21
Host Configuration ...................................................................................................................................22
Optional Equipment................................................................................................................................ 24
Printer, Barcode Scanner or PC
..............................................................................................................24
Using a Barcode Scanner to Scan Patient ID and / or Operator Information .....................................25
How to Wake-Up the MyCare Insite or Switch It OFF ............................................................................25
Test Procedures...................................................................................................................................... 26
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents

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Overview of the Testing and Measuring Procedures ............................................................................26
Operating Safety Precautions .................................................................................................................27
Testing a Patient Sample .........................................................................................................................28
Viewing and Processing Test Results .................................................................................................... 30
Transmitting Results to the Host ............................................................................................................ 31
Analysing a Patient Sample that was Requested by the Host over ASTM .......................................... 31
MyCare Online Services (MyCOS) ........................................................................................................ 33
MyCOS Online Services Registration
.....................................................................................................34
MyCOS Online Services Login .................................................................................................................35
MyCOS Synchronisation .........................................................................................................................35
Synchronise All Test Results ...................................................................................................................35
Synchronise a Single Result ....................................................................................................................36
Synchronise a Filtered Result list ...........................................................................................................36
MyCOS Web Access ................................................................................................................................36
Login Screen .............................................................................................................................................37
Result List .................................................................................................................................................38
Export of Measurement Result List ........................................................................................................39
Printing Measurement Result List ..........................................................................................................39
Quality Control (QC)................................................................................................................................41
QC Materials
............................................................................................................................................. 41
Handling QC Control Materials ............................................................................................................... 41
Frequency of QC Testing .........................................................................................................................42
Correlation............................................................................................................................................... 43
Performing a Parameter Correlation Adjustment
.................................................................................43
Cleaning Instructions ............................................................................................................................. 44
Cleaning the Touch Screen Display
........................................................................................................44
Cleaning the Door & Chamber ................................................................................................................44
Cleaning the Exterior ...............................................................................................................................44
External Interface Description .............................................................................................................. 45
Serial Interface
.........................................................................................................................................45
USB Interface ...........................................................................................................................................45
Error Information and Troubleshooting ............................................................................................... 46
Error Messages and Possible Causes
....................................................................................................46
Service Menu ............................................................................................................................................47
Service Information .................................................................................................................................47
Technical Specifications........................................................................................................................ 48
MyCare Insite Analyser
............................................................................................................................48
Power Supply ............................................................................................................................................48
Options ......................................................................................................................................................48
Shutdown and Waste Management...................................................................................................... 49
Manufacturer Information ..................................................................................................................... 50

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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 and the firmware and
application versions be recorded in the tables provided below. The additional rows in the tables are for any
updates performed on your Analyser. The recorded information is of value if technical support is needed.
The information can be found on the
Connection Screen page 17.
Serial number
The serial number (SN) is also found on the label on the back side of the Analyser or on the box
Firmware versions
Date
Firmware version
Upon receipt
1. Firmware upgrade
2. Firmware upgrade
Application versions
Date
Application version
Upon receipt
1. Application upgrade
2. Application upgrade
Technical Support:
Visit MyCareInsite.com
Email: [email protected]
Introduction

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Notes

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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 cleaning 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 perform 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:
Operator'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
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.
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– to open the door from the User
Service Menu, see page 47
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 to keep
the Touch 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 (page 3).
To activate a symbol tap it with a finger.
In order to perform a test, the RFID card enclosed in the test box 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 with Reagent Cap) into the
Chamber, close the door. The test starts automatically. After the test is completed, the door opens
automatically, remove the test cartridge, and close the door again.
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.
LEDs

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How the MyCare Insite Analyser Laboratory Photometer Works
The MyCare Insite Analyser laboratory photometer is a measuring device. To perform a test, after a blank
measurement without a test cartridge, the MyCare Insite Analyser is loaded with a test cartridge (Cuvette
with Reagent Cap). The Analyser automatically processes the test when the door is closed. The latest LED
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 and are specific to the test box. The Cuvette, Reagent
Cap, and RFID card are colour coded. Check that the RFID card, Cuvette, and Reagent Cap are of the same
colour. RFID cards contain all the specific steps necessary for the Analyser to perform tests, 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 is measured during this process and the measured value is then
mathematically 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
Reagent Cap) 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
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
Synchronise
Synchronises result(s) and Analyser status with the
MyCare Insite servers
Skip
By pass Pending Request list to manually order a test
EMR transmit
The result has been exported to the host (Electronic
Medical Record)
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
Distributor. 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
3
1
2
3
4
5
Note:
please remember to reinsert the transport lock (page 14) 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
operation.
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
•Electrostatic discharge
Transport Lock
Before first use, remove the transport lock.
With the Insite on, open the Chamber door as shown in the Service menu page 47. Pull the
transport lock up from the Chamber of the Analyser.
Note:
keep both the transport lock and the original packaging in case 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
-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
Power Supply Port and
Power Adapter Plug
Power Adapter
Power Cable

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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 48. 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:

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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.
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 Official Saladax
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.
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.
Note: If the standard Android home screen
appears instead, switch the Touch Screen off,
and back on, select “MyCare INSITE Launcher”
and confirm by tapping always.

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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.
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
press to open the settings. Swipe down and select
System, then Languages & input , then
Languages, Add a Language & region , then Language, and choose a language. Delete the default
language to display the new 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 Laboratory 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 10 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 not attempt to open the door manually!
If an error message appears during an analysis, please consult the
“Error information and troubleshooting” section on page 46.

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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. It takes approximately 10 minutes for the Analyser to warm up to its
proper working temperature. In colder environments it may take longer for the 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 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, Hematrocrit, 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 Hematocrit menu
3.4 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.
Tap a desired hematocrit value
and change it using the Touch
Screen keyboard that appears.
Confirm the change(s) 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 .