Vitl Lu-Mini Instructions For Use Manual

Instructions for Use
Instructions for Use
2
This Manual Copyright © 2018 ITL
All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, by any means or in any form, without the prior permission of Integrated Technologies Limited (ITL).
The information contained in this manual is subject to change without notice. ITL assumes no responsibility for any errors that may appear in this or related documentation.
Document: V501007 Revision: 3-1810
Vitl is the brand name for Integrated Technologies’ own range of laboratory products. For further information, please visit the Vitl web site:
www.vitlproducts.com
All sales and technical enquiries should be addressed to:
UK
Vitl Customer Services Integrated Technologies Limited Viking House, Ellingham Way, Ashford, Kent, TN23 6NF United Kingdom +44 (0)1233 638383 sales@vitlproducts.com
USA
ITL Virginia Inc. 305 Ashcake Road, Suite L, Ashland, Virginia 23005 USA +1 804-381-0905 sales@vitlproducts.com
CHINA
Integrated Electronic Systems (Shanghai) Co Ltd T3-11 Unit 201, No. 5001 Hua Dong Road, Pudong, Shanghai 201201, China +86 (0)21 585 854 63 sales@vitlproducts.com
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Contents
1 Symbols Used in this Instruction Manual ..................................................... 6
2 Safety Precautions and Limitations of Use .................................................. 7
3 Regulatory Limitations of Use ................................................................... 11
4 Lu-mini Unit Description ............................................................................ 12
4.1 Acceptable Sample Vessel Types and Fill Volumes ................................. 15
5 Lu-mini Unit Installation ............................................................................. 16
6 Basic Unit Operation .................................................................................. 17
6.1 User Display and Controls ......................................................................... 17
6.2 Powering-up the Lu-mini Unit .................................................................... 20
6.3 Selecting the Active User .......................................................................... 22
6.4 Selecting a Protocol and Performing a Reading ....................................... 24
6.4.1 Selecting a Protocol .................................................................................. 24
6.4.2 Editing the Sample ID ................................................................................ 25
6.4.3 Sample Vessel Insertion and Removal ..................................................... 27
6.4.4 Performing a Reading ............................................................................... 29
6.4.5 Results Status Tagging and Adding a Comment Note .............................. 31
6.5 Viewing the Test Results Database .......................................................... 33
6.5.1 Deleting Test Results from the Lu-mini Database ..................................... 34
6.6 Using the Timer Function .......................................................................... 35
6.6.1 Using an Independent Timer ..................................................................... 36
6.6.2 Using Linked Cascading Timers................................................................ 38
6.6.2.1 Linking Timers into a Single Cascading Group ....................................... 38
6.6.2.2 Linking Timers into Multiple Cascading Groups ...................................... 40
6.6.3 Using the Timers whilst Sample Testing ................................................... 40
6.7 Unit Set-up Options ................................................................................... 41
6.7.1 Setting the Clock and Date/Time Formats ................................................ 43
6.7.2 Beeper and Button Click Volume .............................................................. 43
6.7.3 Remembering the Last Active User ID ...................................................... 44
6.7.4 Define Automatic Sample ID Text Format ................................................. 44
6.7.5 Reader Test Mode ..................................................................................... 45
6.8 Standby Mode and Unit Shutdown Procedure .......................................... 46
7 Lu-mini Windows App and Advanced Unit Configuration .......................... 48
7.1 Installing the Lu-mini Windows App and USB Driver ................................ 48
7.2 Lu-mini App Basic Functionality ................................................................ 50
7.2.1 Page Selection Buttons ............................................................................. 51
7.2.2 Toolbar Options ......................................................................................... 52
7.2.3 Help Menu Options .................................................................................... 52
7.2.4 Data Table Field Editing and Context Menu .............................................. 53
7.3 Data Synchronisation ................................................................................ 56
7.4 Test Results Database Page..................................................................... 57
7.4.1 Uploading Results Data ............................................................................. 58
7.4.2 Exporting Test Results Data ...................................................................... 58
7.4.3 Deleting Results Data ................................................................................ 59
7.5 User IDs Page ........................................................................................... 59
7.6 Global Unit Settings Page ......................................................................... 60
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7.6.1 Adding a New Unit .................................................................................... 61
7.7 Sample Measurement Protocols Page ...................................................... 61
7.7.1 Protocol Name and Reagent Assay .......................................................... 63
7.7.2 Sample Method Types .............................................................................. 63
7.7.2.1 Single Tube Measurements .................................................................... 64
7.7.2.2 Multiple Tube Measurements .................................................................. 64
7.7.2.3 Continuing a Multi-Tube Test from the Worklist ...................................... 66
7.7.3 Measurement Types ................................................................................. 67
7.7.4 Test Result Options and Banding ............................................................. 69
7.7.4.1 Single Sample Result Banding .................................................................... 71
7.7.4.2 Multiple Sample Comparison Bands............................................................ 72
7.8 Reagent Assays Page ............................................................................... 73
8 Troubleshooting ........................................................................................ 75
9 Maintenance and Servicing ....................................................................... 77
9.1 Routine Cleaning and Inspection .............................................................. 77
9.2 Decontamination Procedure ...................................................................... 79
9.3 Transportation and Storage ...................................................................... 80
9.4 Product Disposal ....................................................................................... 80
10 Warranty and Returns ............................................................................... 81
11 Technical Specification ............................................................................. 82
12 Glossary of Terms and Abbreviations ....................................................... 84
WARNING
Please ensure that you have read and fully understood the Safety Precautions and Limitations of Use in Section 2 of this manual before
attempting to install or operate this product. Failure to do so could result in severe injury or may damage the unit and
invalidate the product warranty.
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Tables
Table 1: Advisory Symbol Meanings.......................................................................... 6
Table 2: Unit Features ............................................................................................. 13
Table 3: Unit Accessories ........................................................................................ 14
Table 4: Acceptable Sample Vessel Types ............................................................. 15
Table 5: Main Menu Button Functions ..................................................................... 17
Table 6: Navigation Button Functions ...................................................................... 18
Table 7: Status and Prompt Symbols ...................................................................... 19
Table 8: Result Status Tag Symbols ....................................................................... 31
Table 9: Timer Function Buttons and Status Symbols ............................................. 35
Table 10: User Preferences and Options ................................................................ 42
Table 11: Automatic Sample ID Buttons .................................................................. 44
Table 12: Lu-mini App Page Select Buttons ............................................................ 51
Table 13: Lu-mini App Toolbar Options ................................................................... 52
Table 14: Lu-mini App Help Menu Options .............................................................. 52
Table 15: Data Cell Context Menu Options ............................................................. 55
Table 16: Test Results Database Data Fields ......................................................... 57
Table 17: User IDs Data Fields ................................................................................ 59
Table 18: Unit Settings Data Fields ......................................................................... 60
Table 19: Time and Date Synchronisation Options ................................................. 60
Table 20: Protocols Table Data Fields ..................................................................... 62
Table 21: Sample Method Options .......................................................................... 64
Table 22: Sample Measurement Types ................................................................... 68
Table 23: Reagent Assay Data Fields ..................................................................... 73
Table 24: Troubleshooting Suggestions .................................................................. 75
Table 25: Lu-mini Unit Error Codes ......................................................................... 76
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1 Symbols Used in this Instruction Manual
The following advisory symbols are used in this manual.
Table 1: Advisory Symbol Meanings
DANGER
Indicates a Risk of Electric Shock which could, if not avoided, result in severe injury or death.
DANGER
Indicates a Risk of Explosion which could, if not avoided, result in severe injury or death.
WARNING
Indicates a hazardous situation which could, if not avoided, result in severe injury or death; or severely damage the unit.
CAUTION
Indicates a hazardous situation which could, if not avoided, result in minor or moderate injury; or degrade or impair the functionality of the unit.
CAUTION
Indicates an Electrostatic-Sensitive Device for which care should be taken not to touch the exposed electrical contacts as this could degrade or impair the functionality of the unit.
CAUTION
Indicates a possible crush hazard due to moving parts which could, if not avoided, result in minor or moderate injury.
Advisory or other useful information.
Refer to Lu-mini App advanced features.
NN
Refer to “Section NN” for more details.
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2 Safety Precautions and Limitations of Use
It is essential that all users of this equipment have fully read and understood the following safety precautions and limitations of use before installing or operating the Lu-mini unit.
IMPORTANT
WARNING
The protection provided by this equipment may be impaired if it is not used in a manner described in this manual.
WARNING
It is essential that the user of this equipment is aware of the potential hazards associated with the unit and its accessories.
All operators should be familiar with the safety precautions and warnings given in these instructions before attempting to operate the unit.
Improper use of this unit or its accessories may impair their functionality and invalidate the manufacturer’s warranty.
Unit Handling Precautions
CAUTION
Care should be taken not to drop the unit or subject it to rough physical handling, both during normal use and during installation, transportation and storage.
Do not use the unit if it shows any signs of damage or wear.
WARNING
The unit should be held and supported in both hands when lifting or moving. Do not lift the unit by the lid.
Care should be taken to avoid trapping fingers under the unit when placing it down on a solid surface.
CAUTION
Care should be taken not to knock the LCD display. Do not use excessive force when pressing the touchscreen
buttons or when cleaning it.
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Unit Installation and Operating Environment
DANGER
WARNING
The Lu-mini unit is designed for indoor laboratory use only. The acceptable operating temperature range is 18ºC to 38ºC,
with a relative humidity of 20% to 85% non-condensing, at a maximum altitude of 2000m above sea level.
If the unit is stored in conditions outside of these ranges, it must be left to stand unpowered until it has acclimatised to within these environmental limits before being powered.
DANGER
Use the USB power adaptor provided with the unit. Care should be taken when powering the unit from a computer
USB port or alternative USB power source.
WARNING
Always ensure that the USB power cord is securely inserted into the rear of the unit.
Ensure that any excess power cord does not pose a potential trip or pull hazard.
DANGER
Do not operate the unit in any area which is, or has been, or is thought to have been exposed to explosive or flammable gases, vapours or liquids.
WARNING
The unit must be installed and operated on a solid, stable, vibration-free and level working surface.
CAUTION
For best results, the unit should be installed and operated in a stable thermal environment, out of direct sunlight and away from sources of heat or draught.
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General Operating Precautions
DANGER
Ensure that the power is switched off at the mains outlet before inserting or removing the USB power cord.
If a spillage occurs in or over the unit, switch the power off and unplug the USB cord at the power adaptor before attempting to deal with the spill.
DANGER
The unit is intended for use with aqueous solutions only. Never use the unit with any explosive, volatile or highly
reactive substances or chemicals.
WARNING
To avoid liquid spills and possible cross-contamination of samples, use sealed or capped tubes of the type specified in Section 4.1.
Always follow prescribed laboratory procedures and use appropriate personal protective equipment (PPE - such as gloves, clothing, goggles, etc.) when handling samples.
CAUTION
The unit lid poses a possible finger crush hazard. Take care when opening and closing the lid to ensure hands,
fingers and protective gloves do not get trapped. Do not insert your finger into the reader sample chamber.
CAUTION
The unit lid catch contains a small magnet. Avoid direct contact with any magnetic-sensitive devices or assays.
CAUTION
Avoid touching the contacts of the USB port on the rear of the unit as an Electrostatic Discharge (ESD) could degrade or impair the functionality of the unit.
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Unit Maintenance and Serviceability
WARNING
There are no user or operator serviceable parts inside the unit.
Do not remove the unit casework. Removal of the unit's casework will void the manufacturer’s warranty.
DANGER
Always disconnect the USB power cord from the unit before performing any cleaning or decontamination procedure.
If liquid is spilt into or over the unit, switch off and disconnect the USB from the source before attempting to deal with the spillage.
CAUTION
The use of harsh chemicals and cleaning agents may damage the unit and degrade its performance.
Always follow the cleaning and decontamination procedures specified in Sections 9.1 and 9.2 of this instruction manual.
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3 Regulatory Limitations of Use
Declaration of Conformity
Integrated Technologies Limited (ITL) affirm that this product fulfils the essential requirements of the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU, when installed and operated in accordance with the instructions in this manual.
Safety Standards
EN 61010-1:2010,
EN 61010-2-010:2003
UL 61010-1:2001 3nd Edition (CAN C22.2 CSA 61010-1)
MET Labs NRTL Electrical Safety – Listing No E113628
EMC Standards
EN 61326:2013, Class A
FCC CFR 47 Parts 15.107 and 15.109, Class A
RoHS and WEEE Directive Compliance
This product complies with the requirements of the RoHS2 Directive 2011/65/EU for Electrical and Electronic Equipment and in accordance with BSEN 50581:2012.
Where applicable, the Lu-mini unit should be disposed of in accordance with the European Union WEEE Directive 2002/96/EC on Waste Electrical and Electronic Equipment.
Do not dispose of this product into unsorted municipal waste or public landfill. Please refer to Section 9.4 for details of how to correctly dispose of this product.
The Lu-mini unit is designed and manufactured under ISO 9001 by:
Integrated Technologies Limited
Viking House, Ellingham Way, Ashford, Kent, TN23 6NF United Kingdom
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4 Lu-mini Unit Description
The Lu-mini unit is a benchtop Luminometer and has the following external features:

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Table 2: Unit Features
LCD Touchscreen User Interface
6.1
Unit Lid
6.4
Reader Sample Chamber
4.1
Sample Vessel Eject Button
6.4.3
Power Rating
11
USB Power Inlet
0
Unit Label and Serial Number
0
The unit label is located on the underside of the unit and provides the unit serial number, voltage and power ratings:
There is also a label surrounding the USB Power Inlet at the rear of the unit which provides the voltage and power ratings:
 
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The unit is supplied with the following accessories:
Table 3: Unit Accessories
AC/DC USB Power Adaptor
6.2
USB Power Cable
6.2
11
Lu-mini App Install Flash Drive
7
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4.1 Acceptable Sample Vessel Types and Fill Volumes
The Lu-mini unit is designed to accept the following sample vessel types.
Table 4: Acceptable Sample Vessel Types
Vessel Type
Vessels Sizes
Sample Volumes
Tube
Round round-bottomed 10mm to 12mm diameter 47mm# to 75mm* tall
* Including cap
10mm | 12mm Recommended: 500uL | 800uL Minimum: 200uL | 300uL
Vial
Round flat-bottomed 15mm diameter 48mm# tall
15mm Recommended: 1500uL Minimum: 600uL
Cuvette
Square flat-bottomed
12.5mm square 48mm# tall 10mm path length
12.5mm
Recommended: 1000uL Minimum: 500uL
The recommended tube type is the 12mm x 75mm (5mL) round-bottomed polypropylene test tube with a screw cap. Such as:
Universal Medical Inc - GS-6148R or GS-6148W
Corning Life Sciences - Falcon 352003 or 352058
CAUTION
To avoid liquid spills and possible cross-contamination of samples, use sealed or capped tubes whenever possible.
#
Note: Refer to Section 6.4.3 for specific details on how to insert and remove the sample vessels from the Reader Sample Chamber – particularly for sample vessels with a height of less than 50mm.
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5 Lu-mini Unit Installation
Before installing the Lu-mini unit, please check that the delivery is complete (see Table 3) and that the unit and all accessory parts are intact and free from any signs of transportation damage. Also ensure that all external and internal packaging has been removed from the unit before installation.
Please retain all packaging for future transportation and storage of the unit and its accessories.
The Lu-mini unit should be installed in a location which meets the following requirements:
Safe and suitable operating environment (see Section 2)
Solid, stable, vibration-free and level working surface
At least 10cm clearance around the unit to adjacent objects and walls
Out of direct sunlight and away from sources of heat or draught
WARNING
Please also observe and abide by the Unit Installation and Operating Environment safety precautions and preconditions
listed in Section 2 of this manual.
When the unit is initially installed, the real-time clock will need to set to your local time and date. Please read Section 6 first, and then refer to Section
6.7.1 for details.
NOTE
When the unit is initially powered, or if the unit has been in storage or left unpowered for several months, the internal real-time clock battery will need recharging.
The unit may report an E85 warning (see Section 8). Please leave the unit powered for at least 2 hours (preferably 8
hours) to recharge the battery.
Please refer to Section 7.1 for details on installing the associated Lu-mini Windows App.
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6 Basic Unit Operation
WARNING
Please ensure that you have read and fully understood all of the Safety Precautions and Limitations of Use listed in Section 2 before attempting to operate the Lu-mini unit.
6.1 User Display and Controls
The unit’s user interface consists of a colour LCD touch screen display. The menu structure is divided into two main sections as shown below.
Control and Status
Function and Option buttons
The above screen shows the Main Menu buttons, which provide the following functionality.
Table 5: Main Menu Button Functions
Select active User ID (Any User / Specific User)
6.3
Select Protocol and perform Reading
6.4
View the Test Results Database
6.5
Enter Timer function
6.6
Enter unit Set-up options menu
6.7
Unit Standby and Wakeup modes
6.8
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Below is a list of other menu and data list navigation buttons and their functions.
Table 6: Navigation Button Functions
Accept or Cancel option
6.7
Return to Main Menu
6.1
Return to Previous menu
6.4
Edit Sample ID
6.4
Expand database result
6.5
Test result Status tag
6.4.5
Test result Comment
6.4.5
Jump to Top or Bottom of data list
6.5
Move Up and Down data list or Increase and Decrease value
6.5
Move to Next value
6.7
Other function-specific button icons are explained in Sections 6.3 to 6.8.
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There are also various status and prompt symbols that may appear in the main screen area, as detailed in Table 7 below.
Table 7: Status and Prompt Symbols
Prompt: Open Lid
6.4.3
Prompt: Insert Sample vessel
6.4.3
Prompt: Use specified Tube Number
6.4.3
Status: Sample Inserted correctly
6.4.3
Prompt: Close Lid
6.4.3
Prompt: Remove Sample vessel
6.4.3
When the lid is open, the unit also periodically beeps to prompt the user to close the lid as soon as possible.
For optimum reader performance, the lid should always be kept closed when not inserting or removing a sample vessel.
Please refer to Section 7 for additional buttons and symbols which relate to specific Lu-mini App features.
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6.2 Powering-up the Lu-mini Unit
The Lu-mini unit is powered via a standard USB cable, from the supplied AC/DC USB Power Adaptor. However, it can also be powered from a USB port on a desktop or laptop computer, a USB battery pack or a 12V to USB Car Charger.
AC/DC USB
Adaptor (Supplied)
Computer USB Port
or Powered Hub
USB Battery
Pack
12V to USB
Car Charger
Plug the supplied USB Cable into the Lu-mini Unit and then into the power source, and (if necessary) switch on the power source.
The Lu-mini unit LCD will light-up and display the power-up progress screen whilst the internal data memory is checked and the reader initialised.
Power-up Screen
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Following this the Main Menu screen is displayed.
User ID Screen
Power-Up
Screen
Set-up
Standby
The current time and date are displayed on the Main Menu screen as a visual check that there are correctly set. This is important as the time and date are required for the Reading and Timer options to function correctly.
Note: If the unit clock is not set, the time and date are displayed in Red and the Reading and Timer options are disabled until the clock is set.
To set the clock, press the Set-up options button followed by the Date/Time button. See Section 6.7.1 for more details.
Date
Time
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6.3 Selecting the Active User
The User ID function allows the current active user of the unit to log all the test results they perform against their own personal User ID. To change the User ID, press the User ID button from the Main Menu.
User ID Screen
Main
Menu
Screen
→ →
Cancel
Jump to
Top
Move
Up
Move
Down
Accept
By default, the User ID is set to Any User and there are no other User IDs available to choose from, therefore the Up and Down arrow buttons are disabled. To return to the main menu press the Accept or Cancel button.
Additional User IDs can only be added and edited via the Lu-mini Windows Application. See Section 7.5 for details.
When additional User IDs have been downloaded to the unit, the Up and Down buttons will be enabled to allow the desired User ID to be selected from the list.
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User ID Screen
Main
Menu
Screen
Cancel
Jump to
Top
Move
Up
Move
Down
Accept
The Padlock symbol ( ) on the right indicates that the User ID is password protected (see Section 7.5). When selected, the QWERTY keyboard is displayed to allow the password to be entered.
→ → →
→ → →
Main
Menu
Screen
Enter
password
The User ID and User Name are displayed on the Main Menu screen, and the User ID button changes to a solid figure indicating a specific User ID is active.
By default, the unit remembers the most recently selected User ID and automatically selects this user when the unit is next powered up. To change this behaviour, refer to Section 6.7.3.
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6.4 Selecting a Protocol and Performing a Reading Once the User ID has been checked and set, the sample measurement
Protocol can be selected so that a sample test can be performed.
6.4.1 Selecting a Protocol
The Protocol function allows the user to select the appropriate measurement protocol for the test about to be performed. To select the measurement Protocol, press the Protocol button from the Main Menu.
Protocol Selection Screen
User ID
Protocol Count
Main
Menu
Screen
→ →
Main
Menu
Worklist
Move
Up
Move
Down
Accept
By default, the Protocol selection list consists of just the Standard RLU Measurement with no other protocols to choose from, therefore the Up and Down buttons at the bottom of the screen are greyed-out.
The Worklist button is also greyed-out at this point (see Section 7.7.2.3). There is a small User ID icon at the top of the protocol screen to indicate the
currently active User ID.
Additional Protocols and Worklists can only be added and edited via the Lu-mini Windows Application. See Section 7.7 for details.
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Once the required Protocol has been selected, press the Accept button to start the testing procedure.
Sample
Test
Screen
6.4.2 Editing the Sample ID
The top left corner of the Test screen shows the Sample ID which is a unique ID assigned to the reading result. The figure in the top right corner of the screen shows how full the results Database is.
In the middle of the screen the selected protocol is displayed along with the time and date; and visual prompts to instruct the user on how to perform a reading.
Sample Test Screen
Sample ID
Database Usage
Protocol
Screen
→ →
Previous
Edit
ID
Select
Location
Tube
Select
Accept
The default Sample ID allocation is a sequential numerical ID - however other Sample ID options can be selected from the unit Set-up options menu (see Section 6.7.4 for details).
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If desired, the sample ID can be edited at this point by pressing the Edit button. If this is not required, skip forward to Section 6.4.3.
Edit Sample ID Screen
Test
Screen
→ →
Cancel
Accept
Using the keyboard, the Sample ID can be entered or edited. Once the desired ID has been entered, press the Accept button to continue or the Cancel button to undo and return to the Test screen.
Edit
Sample ID
Screen
Edit Sample ID
→ →
Sample
Test
Screen
No edit required
If the unit has been set-up to have no automatic Sample ID (see Section 6.7.4) the QWERTY keyboard will automatically appear as soon as the test begins.
At the bottom of the sample Test screen, the Location and Tube Select buttons are greyed-out as these features are only available when using the Lu-mini Windows Application. See Section 7 for details.
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