Related Manuals for Saladax MyCare Insite
Summary of Contents for Saladax MyCare Insite
- Page 1 USER MANUAL Saladax Biomedical 116 Research Dr. Bethlehem, PA 18015 USA Tel: +1 (610) 419-6731 Fax: +1 (484) 547-0590 MyCareInsite.com PI MCI-EUR Rev 04 1 / 50 PI MCI-EUR Rev 05...
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Page 2: Symbols & Abbreviations
Symbols & Abbreviations 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 & Abbreviations Symbols Explanation Conformity marking according to the directive 2014/30/EU of the European... - Page 3 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...
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Page 4: Table Of Contents
Getting Started ............................13 ......................13 Inspecting the Package Contents ......................... 13 MyCare Insite Packaging ......... 14 The Proper Placement of the MyCare Insite Analyser Laboratory Photometer ............................14 Transport Lock ......................... 14 Connecting the Power Supply ............................ 15 Proper Grounding Table of Contents ............................ - Page 5 Error Messages and Possible Causes ............................47 Service Menu ..........................47 Service Information Technical Specifications ........................48 ..........................48 MyCare Insite Analyser ............................48 Power Supply ..............................48 Options Shutdown and Waste Management ...................... 49 Manufacturer Information ........................50 PI MCI-EUR Rev 05...
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Page 6: Introduction
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. - Page 7 Notes PI MCI-EUR Rev 05 7 / 50...
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Page 8: Intended Use Of 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. -
Page 9: System Description
System Description 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. -
Page 10: Indicator Lights
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). -
Page 11: How The Mycare Insite Analyser Laboratory Photometer Works
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. -
Page 12: Pictograms / Button Symbols
Pictograms / Button Symbols 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... -
Page 13: Getting Started
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: 1. -
Page 14: The Proper Placement Of The Mycare Insite Analyser Laboratory Photometer
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. -
Page 15: 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. -
Page 16: The Touch Screen
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. -
Page 17: Starting & Operating The Touch Screen
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. -
Page 18: The Automatic Start-Up And Warm-Up Processes
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. -
Page 19: Configuring The Mycare Insite
Configuring the MyCare Insite 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 to open the Settings Tap the setting you want to menu. -
Page 20: Setting Units
Setting Units 1. Settings menu 2. Unit selection menu Units to open the Unit If alternate units are available, tap selection menu. and select a unit in the drop- down menu. Confirm change(s) with Configuring Inputs (Sex, Sample Type, Hematrocrit, Operator) 1. -
Page 21: Configuring Printer
Configuring printer 1. Settings menu 2. Interface menu 3. Printer configuration menu Interface Printer Printer model in the Settings to select the menu. Interface menu standard printer model (see appears. 3.1) Automatic printout Activate “ ” automatically print results after each measurement. -
Page 22: Host Configuration
After pressing OK on options. the password screen, the host If you do not know the Service configuration menu opens. Password, please contact your Official Saladax Distributor. 3.2. Host configuration menu 3.3 WiFi Network Information 4. Host configuration menu WiFi Network EMR/LIS... - Page 23 5. EMR/LIS protocol menu 5.1 ASTM TCP/IP protocol 5.2 HL7 TCP/IP protocol HL7 TCP/IP By default, the EMR protocol is There are several options to The options for the disabled. Tap to show the consider for the ASTM TCP/IP protocol are as follows: different protocols and choose protocol: Automatic transmission...
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Page 24: Optional Equipment
(e.g. a printer) can increase the amount of leakage current. To ensure safe operation, always use the MyCare Insite according to the instructions in the User Manual. To install a printer or barcode reader (see “Technical Specifications” section on page 48) please connect the RS-232 cable to the RS-232 port on the Analyser (see illustration below) . -
Page 25: Using A Barcode Scanner To Scan Patient Id And/Or Operator Information
How to Wake-Up the MyCare Insite or Switch It OFF Pressing the Lock Switch will re-illuminate the display. The Lock Switch button dims the screen. It is not necessary to switch the Analyser off every day. Switching the Analyser off completely can only be done by disconnecting it from the power supply. -
Page 26: Test Procedures
Place the RFID card provided in the test box in the RFID card well on top of the Analyser Enter the required patient data Prepare a patient sample according to the instructions in the MyCare Insite Test package insert Insert the cartridge into the Analyser and start the test measurment by closing the door At the end of the measurement: The door will open;... -
Page 27: Operating Safety Precautions
Use gloves when handling and disposing of Cuvettes, patient samples, and sample collection equipment that pose a potential biohazard risk Please refer to package insert provided for the MyCare Insite Test at MyCareInsite.com and follow all instructions including: o The proper temperature of a test before it can be used... -
Page 28: Testing A Patient Sample
Testing a Patient Sample 1. RFID card placement 2. Main menu 3.Test screen Take the provided RFID card out The MyCare Insite displays the test in the main menu of the test box and place it on name number tests to start a measurement. - Page 29 6. Insert cartridge and close door The door opens automatically. Insert the test cartridge (Cuvette with Reagent Cap) and close the door. The test procedure starts automatically. The Touch Screen displays the following information during the testing process (varies by test): Mixing Incubating Measuring...
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Page 30: Viewing And Processing Test Results
Viewing and Processing Test Results After processing a test, the result screen appears on the Touch Screen: 1. Result Screen The test result is displayed on the Touch Screen. to scroll back and forth within the results. to export to a HIS/LIS or PC or send as email. to print. -
Page 31: Transmitting Results To The Host
Transmitting results to the host 1. Main Menu 2. Result List Screen 3. Result Export to export to the host. A dialogue will appear. Tap main export all results. menu to open the Result List. Filter By tapping on , the results to be exported can be filtered by date. - Page 32 4a. Wrong RFID card on Analyser 4b. Correct RFID card on Analyser 5. Input menu If the RFID card matches the Tap the input field to enter data. Please make sure that the correct ordered test, the sample can be to confirm and start the RFID for the test ordered by the measured.
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Page 33: Mycare Online Services (Mycos)
Synchronisation Web Access The MyCare Insite offers the possibilty to store test results on the encrypted MyCare Online Services (MyCOS) servers. MyCOS provides a simple and secure way to manage MyCare Insite results from any PC or tablet with internet connection. Doctors and laboratories have the option to view (with patient name and ID), filter, and process results. -
Page 34: Mycos Online Services Registration
MyCare Online Services Registration The MyCare Insite application asks the user to register or login to the MyCOS once before synchronising. The following steps describe the registration process. 1. MyCOS Registration & Login Screen 2. Terms of Services 3. Registration... -
Page 35: Mycos Online Services Login
MyCare Online Services Login 1. MyCOS Registration & Login Screen 2. Login Screen Provide your MyCOS account Press to open the login information and tap to log in. screen. MyCOS Synchronisation Once registered and logged in with a MyCOS account, Insite result synchronisation is enabled. There are three ways to synchronise data: •... -
Page 36: Synchronise A Single Result
Synchronise a single result 1. Main Menu 2. Result List Screen 3. Result Detail Screen Tap a result to open the result detail to synchronise the result in the main menu to screen. currently viewed. open the Result List. Synchronising a filtered result list 1. -
Page 37: Login Screen
Recommended web-browsers Web browsers that are recommended to use for accessing the MyCOS Web Access are shown in the table below. Other browsers are not recommended. • Windows Internet Explorer 10 or higher • Mozilla Firefox 24 or higher • Google Chrome 33 or higher •... -
Page 38: Result List
Result List Filtering: Test: Choose the test to be displayed Analyser: Choose an Analyser that is connected to the MyCOS account Result-Type: Choose if sample or controls should be displayed Patient ID/Patient Name: Choose which Patient IDs/Names should be displayed Date(s): Select a time frame Button to apply the chosen filter(s) Button to reset the filter... -
Page 39: Export Of Measurement Result List
Tap the “more results” button to add the chosen number of results to the result view: (12) Button to export currently shown results as Excel or CSV file. Choose the desired file format in the drop-down menu: Export of Measurement Result List Before being exported, the results can be filtered with the filter button in the result screen. - Page 40 Header User Interface Elements This shows the currently logged in user as well as the language option. PI MCI-EUR Rev 05 40 / 50...
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Page 41: Quality Control (Qc)
Quality Control (QC) A quality control program should be performed on a regular basis to verify the MyCare Insite Analyser is working properly and providing reliable results. Data integrity can only be assured when controls and Good Clinical Laboratory Practice are used routinely. The frequency of performing QC differs from laboratory to laboratory. -
Page 42: Frequency Of Qc Testing
4. Repeat the control test, using a new control from the same lot If all instructions have been followed but control results are still not within range, please contact your Official Saladax Distributor for assistance before testing any patient samples. -
Page 43: Correlation
Correlation Performing a Parameter Correlation Adjustment 1. Start-up Menu 2. Settings menu 3.1 Password screen Settings Correlation to open the settings to open the Enter the password. The default menu. correlation menu. setting is 3010. 4. Correlation menu 5. Test Screen to open a drop-down An active correlation adjustment Correlated... -
Page 44: Cleaning Instructions
The cartridge area may be cleaned with a cotton swab moistened with isopropyl alcohol. Cleaning the Exterior The surface of the MyCare Insite Analyser should be cleaned with a clean, lint-free cloth only moistened with isopropyl alcohol. Wipe down the exposed surfaces. -
Page 45: External Interface Description
External Interface Description Serial Interface Interface parameters Interface signals Parameter Value Signal Baud rate 9600 Data bits Parity None Stop bits Data format Data is transmitted in blocks of data sets. One data set contains the data from one analysis. Data sets consist of data fields. -
Page 46: Error Information And Troubleshooting
Cartridge has not been Cuvette. Door blocked inserted completely or the Reagent Cap Please contact your Official Saladax does not cap the Cuvette firmly enough. Distributor if the door fails to open at the end of a run. -
Page 47: Service Menu
Door open to open the door. Service Information If a problem persists after the corrective actions are taken, contact your Official Saladax Distributor for technical assistance. Before requesting assistance, please have the following information ready: • the serial number of your Insite Analyser •... -
Page 48: Technical Specifications
Technical Specifications MyCare Insite Analyser Photometer resolution 0.0001 ABS Reproducibility < 1.5% CV at 1 OD Linearity 0.1000 – 3.0000 OD better than 1.5% and 0.01 OD ± ± Temperature control Electrical temperature control of the photometer unit to 37°C 2°C... -
Page 49: Shutdown And Waste Management
Shutdown and Waste Management Before shutting down the MyCare Insite for repair or disposal, ensure that there is no Cuvette left in the Analyser Chamber. To protect the Analyser in shipping the original packaging must be used. For proper waste management according to the Directive 2012/19/EU please contact your Official Shutdown and Waste Management Saladax Distributor. -
Page 50: Manufacturer Information
Manufacturer Information Manufacturer Information Saladax Biomedical, Inc. 116 Research Dr. Bethlehem, PA 18015 USA Tel: +1 (610) 419-6731 Fax: +1 (484) 547-0590 MyCareInsite.com Manufacturer Information Saladax Biomedical, Inc. 116 Research Dr. Bethlehem, PA 18015 USA Tel: +1 610 419-6731 Fax: +1 484 547-0590 MyCareInsite.com...