Operator Manual
99 Pages
Preview
Page 1
Idylla™ Operator Manual CSW/4.2
Biocartis NV Generaal de Wittelaan 11 B3 2800 Mechelen, Belgium www.biocartis.com BCT006631 P1010 (Console) and P0010 (Instrument)
12/2016
Table of Contents 1 Preface
6
1.1 Conventions Used in this Manual
6
1.1.1 System Components Naming Conventions
6
1.1.2 Notes
6
1.2 About This Manual
7
1.3 Related Documentation
7
1.4 Commonly Used Symbols
8
1.5 Service and Technical Assistance
10
1.6 User Documentation
11
1.6.1 Secure Area
11
2 Introduction of the Idylla™ System
13
2.1 Intended Use of the System
13
2.2 System Components
13
2.2.1 Console
14
2.2.1.1 Console User Interface
15
2.2.2 Cartridge
18
2.2.2.1 Cartridge Labeling
18
2.2.3 Instrument
20
2.2.3.1 Instrument User Interface
21
2.3 Principles of Operation
22
2.4 Idylla™ System Specifications
23
2.4.1 Environmental Specifications of the Idylla™ System
23
2.4.2 Technical Specifications of the Instrument
23
2.4.3 Technical Specifications of the Console
24
2.4.4 Technical Specifications of the Switch
24
2.4.5 Barcode Reader Specifications
25
3 Installation and Setup
26
3.1 Related documentation
26
3.2 Unpack and Connect the System
26
3.3 Initial Idylla™ System Configuration
26
3.4 Install a Test Type Package
27
3.4.1 Automatic Test Type Package Installation
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28
4 Getting Started
29
4.1 Power On/Off the Console
29
4.2 Power On/Off the Instrument
30
4.3 Log On/Off to the Console
30
4.3.1 Configure Automatic Log Off
31
4.4 Customize the Console
32
4.4.1 Language and Touch Screen Keyboard Layout
32
4.4.2 Sound
33
4.4.3 Screen Brightness
34
4.4.4 Barcode Reader Supporting Light
34
4.5 Change Your User Name
35
4.6 Change Your Password
36
4.7 Configure the Password Policy
36
4.8 Change the Lab Information
37
4.9 Monitor the Status of Instruments and Tests
38
4.10 Use the Barcode Reader
40
4.11 Use an External Keyboard and Mouse
41
5 Idylla™ System Settings Configuration
42
5.1 User Management
42
5.1.1 Understand User Accounts and User Roles
42
5.1.2 Create a User Account
44
5.1.3 Change the Permissions or Rights for the Lab User Role
44
5.1.4 Assign a Different Role to a User Account
45
5.1.5 Change the Password Associated with a User Account
45
5.1.6 Deactivate a User Account
46
5.2 Configure the Console Name
47
5.3 Configure the Network
48
5.3.1 Connection to LAN
48
5.3.2 DNS Server Settings
49
5.4 Configure Communication with the LIS
49
5.5 Configure the Date and Time
50
5.6 Configure Plug and Play Settings
52
5.7 Configure Idylla™ Connect
52
5.7.1 Idylla™ Explore
53
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5.7.2 Service Requests
54
5.8 Configure and Access the Shared Folder
55
5.8.1 Enable the Use of the Shared Folder
55
5.8.2 Access the Shared Folder
56
5.9 Configure Automatic Release of Test Results
57
5.10 Configure the Instrument Names
57
5.11 Install and Configure a Printer
58
5.11.1 Installation of Existing Network Printer
58
5.11.2 Configure paper size of printed pages
59
5.12 Check Technical Details of an Instrument
60
5.13 Configure Instrument Process Logging
61
6 Instructions for Use of the Idylla™ System
62
6.1 Sample Processing Workflow
62
6.2 Unpack a Cartridge
62
6.3 Create a Test Request
62
6.3.1 Create a Manual Test Request
62
6.3.1.1 System Checks
64
6.3.2 Complete a Test Request from the LIS
64
6.3.3 Perform a Quality Control Test
65
6.4 Prepare a Cartridge and Load It into an Instrument
66
6.4.1 Insert a Sample into a Cartridge
66
6.4.2 Identify an Instrument
66
6.4.3 Load the Cartridge and Start the Test
67
6.5 Monitor the Test Progress
67
6.6 Work with the Test List
68
6.7 View the Test Result
68
6.7.1 Make a PDF Report of a Single Test Result
69
6.7.2 Export Assay Logs of a Single Test
70
6.8 Release or Reject Test Results
70
6.9 Dispose of Processed and Expired Cartridges
71
6.10 Print PDF Reports
71
6.10.1 Export PDF Reports to a USB Storage Device
72
6.10.2 Print a Report
72
6.11 Export Tests and Statistics
73
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6.12 Delete Finalized Tests
76
6.13 Cancel a Test Request
77
6.14 Abort a Test in Progress
77
6.15 Clear an Instrument Error
78
7 Service and Maintenance
79
7.1 Maintenance Overview
79
7.2 Install Software and Updates
80
7.2.1 Cyber Security
81
7.3 Lock the Console Screen for Cleaning
82
7.4 Clean the Idylla™ System
82
7.4.1 Clean the Cartridge Tray
83
7.4.2 Clean a Cartridge
83
7.5 Decontaminate the System
83
7.6 Preventive Maintenance
84
7.7 Configure Maintenance Due Settings
84
7.8 Calibrate the Console Touch Screen
85
7.9 Instrument Self-Diagnostic Test
85
7.10 Collect Debug Information
86
8 Safety Precautions
87
8.1 General Safety
87
8.2 Electrical Safety
87
8.3 Mechanical Safety
88
8.4 Biohazard Safety
88
8.5 Cleaning and Decontamination Safety
88
8.6 Lift or Move the System
88
9 Troubleshooting
89
10 Regulatory Compliance
92
10.1 FCC Warnings and Notes
93
11 Authorized Representatives
94
12 Third Party Software and Copyright Information
97
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1 Preface
Idylla Operator Manual
1 Preface 1.1 Conventions Used in this Manual 1.1.1 System Components Naming Conventions Idylla™ System or System refers to one Console used together with one or more Instruments and an Idylla™ Test. Idylla™ Instrument or Instrument (A) refers to the System component processing the Tests. Idylla™ Console or Console (C) refers to the System component acting as a user interface to the Instrument, to remote service provision (when connected to the internet) and, optionally, to a Laboratory Information System (LIS). Idylla™ Cartridge or Cartridge (B) refers to the disposable container holding the necessary reagents to perform a Test with the System. Idylla™ Test or Test refers to the Cartridge, including the Test-specific software (TTP) that executes the Test, and the automated interpretation and reporting of results.
A
B
C
A Test Type Package or TTP is the Test-specific piece of software that is used for running a specific Test. A TTP recipe contains the processing steps the Instrument must perform to come to a Test result. TTPs are installed separately on the Console. Idylla™ Connect refers to the ‘Internet of Things’ middleware established by Biocartis to connect Idylla™ Systems to a central system to provide added value services. Idylla™ Explore refers to one of the added value services that build on top of Idylla™ Connect. It provides for instance PCR curve visualization capabilities. The Supervisor is the user that has the supervisor role on the Idylla™ Console. The Supervisor can configure certain parameters of the Idylla™ System to the laboratories' wishes. The Lab User is the user that works with the System on a daily basis.
1.1.2 Notes Following notes are used in this manual to alert you to important information. WARNING Indicates a possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. CAUTION Indicates a possibility of device malfunction, device failure, damage to the device or other property, loss of data, or invalid results, associated with its use, or misuse of the device. A caution statement may include a precaution that should be taken to avoid the hazard.
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1.2 About This Manual
Idylla Operator Manual
I NFORMATION Indicates additional information about the current topic or procedure, refers to other topics in this or other manual(s). T IP Indicates tips, tricks, and useful information for using the System.
1.2 About This Manual This manual provides instructions on how to use the System. Please read the entire manual carefully before using the System. WARNING Biocartis assumes no liability for any use of the System without taking into account the instructions contained in this manual. Failure to follow these instructions may entail safety hazards, personal injury, damage to the System, or invalid results. Make this manual available for the intended users. This manual is intended for users who will be working with the System. The instructions in this manual are written with the assumption that you have been properly trained on how to use the System.
1.3 Related Documentation This manual also refers to related user documentation. DOCUMENT
LOCATION
Idylla™ System Site Preparation Guide
Biocartis website Secure Area
Idylla™ Lab Integration Guide (for IT-departments)
Biocartis website Secure Area
Idylla™ Safety Sheet
Included in the Instrument and Console boxes
Installation Qualification (IQ) Report: Idylla™ Console
Included in the Console box
Installation Qualification (IQ) Report: Idylla™ Instrument
Included in the Instrument box
Operational Qualification (OQ) Report: Idylla™ System
Performed by a customer service provider at your premises
Test-specific Instructions for Use (IFU) per Idylla™ Test
www.biocartis.com/ifu, a Test-specific keycode is required for access
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1.4 Commonly Used Symbols
Idylla Operator Manual
1.4 Commonly Used Symbols SYMBOL
R EFERENCE
DESCRIPTION Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified.
ISO 15223-1:2012* Symbol Ref. No. 5.1.6
Batch Code Indicates the manufacturer’s batch code so that the batch or lot can be identified.
ISO 15223-1:2012* Symbol Ref. No. 5.1.5
Date of manufacture
ISO 15223-1:2012*
Indicates the date when medical device was manufactured.
Symbol Ref. No. 5.1.3
Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
ISO 15223-1:2012* Symbol Ref. No. 5.1.1
Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
ISO 15223-1:2012* Symbol Ref. No. 5.1.7
Use-by date
ISO 15223-1:2012*
Indicates the date after which the medical device is not to be used.
Symbol Ref. No. 5.1.4
Consult Instructions for Use
ISO 15223-1:2012*
Indicates the need for the user to consult the instructions for use.
Symbol Ref. No. 5.4.3
Contains sufficient for <n> tests
ISO 15223-1:2012*
Indicates the total number of IVD tests that can be performed with the IVD kit reagents.
Symbol Ref. No. 5.5.5
Do not re-use ISO 15223-1:2012*
Indicates a medical device that is intended for one use, of for use on a single patient during a single procedure.
Symbol Ref. No. 5.4.2
Do not use if package is damaged
ISO 15223-1:2012*
Indicates a medical device that should not be used if the package has been damaged or open.
Symbol Ref. No. 5.2.8
Patient number
ISO 15223-1:2012*
Indicates a unique number associated with an individual patient.
Symbol Ref. No. 5.7.1
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1.4 Commonly Used Symbols
Idylla Operator Manual
For IVD performance evaluation only ISO 15223-1:2012* Symbol Ref. No. 5.5.6
Indicates an IVD device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use. In vitro diagnostic device.
ISO 15223-1:2012*
Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.
Symbol Ref. No. 5.5.1
Serial Number.
ISO 15223-1:2012* Symbol Ref. No. 5.1.7
Indicates the manufacturer’s serial number so that a specific medical device can be identified.
N/A
For Emergency Use Authorization only
ISO 7010:2010**
General Warning Sign
Symbol Ref. No. W001
To signify a general warning. Alternating Current.
IEC 60417:2002***
To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
Symbol Ref. No. 5032
Direct Current. IEC 60417:2002***
To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.
Symbol Ref. No. 5031
Indicates that the product was tested and has met the certification requirements for component products.
N/A
Country: Canada, U.S. Directive 2012/19/EU of 4 July 2012 on waste electrical and electronic equipment (WEEE)
(barcode)
Waste Electrical and Electronic Equipment. The symbol indicating separate collection for EEE.
Directive 98/79/EC on in vitro diagnostic medical devices
CE mark
N/A
Keycode icon (keycode). The code printed next to this icon is to be used to obtain user documentation
N/A
For Research Use Only, not for use in diagnostic procedures
N/A
Functions as an Unique Device Identifier
N/A
Open/Close button on the Instrument tray
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1.5 Service and Technical Assistance
Idylla Operator Manual
I indicates the ON position of the Instrument power switch
N/A
O indicates the OFF position of the Instrument power switch Indicates the power button located on the top right of the Console
N/A
Storage and transport Fragile, handle with care.
ISO 15223-1:2012*
Indicates a medical device that can be broken or damaged if not handled carefully.
Symbol Ref. No. 5.3.1
Keep dry.
ISO 15223-1:2012*
Indicates a medical device that needs to be protected from moisture.
Symbol Ref. No. 5.3.4
Keep away from sunlight.
ISO 15223-1:2012*
Indicates a medical device that needs protection from light sources.
Symbol Ref. No. 5.3.2
This way up.
ISO 7000:2014****
To indicate correct upright position of the transport package.
Symbol Ref. No. 0623
*15223-1 Second Edition 2012-07-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements FDA recognition number: 5-90 **ISO 7010:2011 Graphical symbols -- Safety colours and safety signs -- Registered safety signs *** IEC 60417:2002 Graphical Symbols For Use On Equipment FDA recognition number: 5-102 ****ISO 7000 Fifth Edition 2014-01-15 Graphical Symbols For Use On Equipment - Registered Symbols FDA recognition number: 5-103
1.5 Service and Technical Assistance For assistance with Idylla™ products, contact your local Customer Service provider by telephone, website, or email. Please make sure you can provide the following when you call or email: l
l
the Serial Numbers of the System (printed on the labels on the backside of the Instrument and the Console) the number of the Cartridge (provided on the bottom of the Cartridge itself)
T IP You can find a list of distributors per region on www.biocartis.com/distributors. Contact details for Biocartis Customer Service (manufacturer): l l l l
Name: Biocartis Customer Service Phone: +32 15 632 888 E-mail: [email protected] Website: www.biocartis.com
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1.6 User Documentation
Idylla Operator Manual
1.6 User Documentation User documentation, such as this manual, and Instructions for Use, can be obtained through the website www.biocartis.com/ifu. Some documentation, such as the Site Preparation Guide and Lab Integration Guide can only be obtained through the Biocartis website secured area. You need the keycode, recognizable with , to obtain a specific document. It is displayed on the product labeling for IFU's, or on the About screen of the Console for the Operator Manual. If you wish to receive a printed version, please call (free of charge unless otherwise indicated): T ELEPHONE N°
COUNTRIES COVERED
+ 800 135 79 135
l
l
0800 59 11055
Brazil
+1 855 805 8539
Canada
0800 804 804
Croatia
0800 0100567
Estonia
00800 161 2205 7799
Greece
800 8996
Iceland
+31 20 796 5692
EUROPE: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Luxemburg, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, UK NON-EUROPE: Argentina, Australia, Colombia, New Zealand, Russia, Uruguay
Liechtenstein (paid number)
8800 30728
Lithuania
T ELEPHONE N°
COUNTRIES COVERED (CONTINUED)
+31 20 796 5693
Malta (paid number)
0800 895 084
Romania
0800 606 287
Slovakia
00800 142 064 866
Turkey
+1 855 236 0910
USA
+31 20 794 7071
Rest of World
I NFORMATION Please do not call these numbers for technical or customer support.
1.6.1 Secure Area On the Biocartis website secure area, you can find extra user documentation, such as the Site Preparation Guide. The secure area is also the repository for the TTPs (Test Type Packages, specific software programs used for running a specific Test) or Instrument software update packages. It is recommended that at least the person who takes up the Supervisor role, has access to the secure area, in order to keep the Idylla™ System up-to-date.
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1.6.1 Secure Area
Idylla Operator Manual
To create an account to access the secure area, follow these steps: 1. Go to www.biocartis.com. The Biocartis website appears. 2. Click the Order & Support menu item. The Order & Support menu unfolds. 3. Click the Create Account menu item. The Create User Account page appears. 4. Complete your details in the form. 5. Click Submit. The form containing your details is submitted and transferred to Biocartis Customer Service for verification. 6. After verification of Biocartis Customer Service, you will receive an email. Open the email message. T IP If you did not receive an e-mail within 5 days, please check your email spam folder. If the email cannot be found, please contact Biocartis Customer Service. 7. Click on the link in the email message. A new window opens. 8. Choose and confirm your password. Your account is now ready for use.
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2 Introduction of the Idylla™ System
Idylla Operator Manual
2 Introduction of the Idylla™ System 2.1 Intended Use of the System The Idylla™ System is an in vitro diagnostic (IVD) medical device, consisting of the Idylla™ Console and the Idylla™ Instrument. The System is intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific Idylla™ Cartridges. Idylla™ covers the entire process from sample to result, including for example liquefaction, cell lysis, DNA/RNA extraction, real-time amplification/detection, and data analysis and reporting. The Idylla™ System is intended for use with approved/cleared in vitro diagnostic Tests and other Assays labeled for use on the System.
2.2 System Components The Idylla™ System consists of a Console, one or more Instruments, and an Idylla™ Test. The Instruments can be used on demand for processing Idylla™ Tests.
A
B
C
1. Front view of a possible Idylla™ System setup with a stack of three Instruments (A), a Test Cartridge (B), and a Console (C)
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2.2.1 Console
Idylla Operator Manual
2.2.1 Console The Console is the part of the System that is used to schedule and manage Tests on the Instrument. The Console serves as an interface to local lab infrastructure: l l l
Printer Laboratory Information System (LIS), User PC's.
The Console also serves as an interface to the outside world through Idylla™ Connect (when connected to the Internet). The Console provides a display and a barcode reader. The power switch
is located on the top right of the Console.
A
B C
2. Front view of the Console, with the power on switch (A), screen (B), and barcode reader (C).
The Console lets the user l l l l
manage Test runs, manage a workflow to create Test requests, monitor Test progress and view, release and export Test results.
In addition, a Supervisor role user uses the Console to configure the System (e.g. user accounts, System configuration) and to perform basic service and maintenance tasks (e.g. software updates, self-diagnostic Tests). The Console’s touch screen can best be used by touching it with your fingers. T IP The touch screen is optimized for use with either gloved or bare fingers; a stylus is not recommended. The Console can be physically connected to: l l
the laboratory network via the LAN interface connector, marked with LAN up to four Instruments using the Instrument interface connectors, marked with INS.
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2.2.1.1 Console User Interface
B
Idylla Operator Manual
A
C
3. Connection of Instruments (A) via an Ethernet® switch (C) to the Console (B).
By using an external Ethernet® switch, up to eight Instruments can be connected to one Console: three directly to the Console and five via the Ethernet® switch. INS
INS
INS
INS LAN
USB
USB
USB
USB
4. Placement of the Instrument and USB ports on the back of the Console
Furthermore, the Console has four USB ports at the back. These ports can be used to connect an external keyboard, a mouse or a USB mass storage device.
2.2.1.1ConsoleUserInterface The Console provides a graphical user interface. The figure below illustrates this user interface, by means of the Status Overview screen.
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2.2.1.1 Console User Interface
Idylla Operator Manual
A
Status Overview
27 May 2014 09:22
B
Instrument Test Type
Sample ID
Status H
G
S1
Acclimatizing
S2
Free
S3
Test2
S4
Test3
Start failed
0:03 F
S5
Free
S6
Service required
S7
Free
S8
Aborted
Test22
C LIS
Administrator
?
Log Off
Status Overview
E
New Test
Test List
Menu
About
D
5. Console User Interface
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2.2.1.1 Console User Interface
LETTER
Idylla Operator Manual
MEANING
A
The title bar shows the name of the current screen and the local date and time.
B
The headings indicate which information is displayed in the Instrument status bars.
C
Status icons for: l
This icon is only shown when the Console date and time is not aligned with the configured NTP-server. It disappears again when the NTP-server can be reached again and time runs synchronously. Installing updates: new software or other updates are ready to be installed.
l
l
LIS: connection active.
l
LIS: connection inactive.
l
Idylla™ Connect: connection active.
l
Idylla™ Connect: connection inactive.
T IP If the System is not configured to enable a connection to a LIS, no LIS connection icon is displayed. If the System is not configured to enable Idylla™ Connect, no Idylla™ Connect icon is displayed. If a service request is pending, the Idylla™ Connect icon is blinking. D
The menu bar contains menu buttons for basic tasks. The main actions that you can perform using the menu bar are: l l l l l
Status Overview: To monitor running Tests and to view the status of your Instruments. New Test: To create new Test Requests. Test List: To view scheduled Tests, past Tests, Test results. Menu: To configure System settings, to manage users and to perform maintenance tasks. About : To view a page with Console and Lab information. This page also contains the keycode for downloading the Operator Manual.
E
Button for logging on (when logged off) and logging off (when logged on).
F
Instrument status bar. Each status bar represents one connected Instrument.
G
Instrument name.
H
Instrument status. I NFORMATION See chapter 4.9: Monitor the Status of Instruments and Tests
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2.2.2 Cartridge
Idylla Operator Manual
2.2.2 Cartridge Cartridges are single-use containers that hold the necessary reagents to perform specific Tests. To be able to run a Test Cartridge on Idylla™, a Test-specific software package (TTP, or Test Type Package) must be installed on the Console. C B
A D
6. Top view of a Cartridge, with the Cartridge lid (A), Cartridge opening (B), barcode (C), and Cartridge clip (D).
The sample is transferred to the Cartridge after opening the Cartridge lid. After taking off the clip and closing the lid, the Cartridge is loaded into the Instrument for processing. Once the sample has been inserted into the Cartridge and the Test has started, all sample preparation and other processing steps take place within the sealed and closed Cartridge. After use, the Cartridge is considered to be a waste container. This container must be treated in accordance with local regulations for disposal of hazardous waste. The design of the disposable Cartridges can be slightly different, depending on the sample transfer method and the Test. All Cartridges are individually packaged in a sealed pouch.
2.2.2.1CartridgeLabeling The Cartridge top layout is as follows:
l l l l
l l l
l l
7. Cartridge top layout
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A: Manufacturer B: Cartridge barcode C: Test name D: Reference number (catalog number) E: Lot number F: Date of Expiration (UTC time) G: Test-specific labeling, for example CE, IVD, RUO, ... H: For single use only I: Sample ID number-field
2.2.2.1 Cartridge Labeling
Idylla Operator Manual
10000021
A
B 8. Cartridge bottom layout
On the bottom of the Cartridge, you can find a barcode and a number, (A) on the figure above. You will need this number when you contact your local Customer Service provider in case of Cartridge issues. (B) identifies the lysis pad. CAUTION Do not touch the lysis pad with your fingers. CAUTION Only place stickers on the top of the Cartridge, in the sample number field.
BIOCARTIS BIO REF 12345678901234 LOT 12345678 YYYY-MM-DD
2
The position of the label shown above is incorrect. The arrow on the figure shows that an important part of the Cartridge is blocked.
BIOCARTIS BIO REF 12345678901234 LOT 12345678 YYYY-MM-DD
2
The position of the label shown above is correct.
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2.2.3 Instrument
Idylla Operator Manual
2.2.3 Instrument The Instrument processes the Test-specific Cartridges according to the corresponding TTP. Each Test has its own specific Cartridge and TTP. The Test-specific TTP directs the actions of the Instrument for the processing of the Test. After processing, the Test result is shown on the Console. Each Instrument contains a tray for loading a single Cartridge.
B
A
9. The Instrument with the Instrument tray (A) and the open/close-button (B).
A maximum of four Instruments can be stacked. A maximum of eight can be connected to one Console. To connect more than four Instruments, the use of an external Ethernet® switch is mandatory. I NFORMATION Please note that this external Ethernet® switch is not provided when ordering an Idylla™ System.
B
A
C
10. The Instruments (A) connected to the Console (B) via an Ethernet switch (C).
When connecting an Instrument to a Console and starting it up (flashing red/white lights below the tray. See chapter 2.2.3.1), it takes about a minute before the Instrument has fully started up and becomes operational. The power switch is located at the rear of the Instrument.
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