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