IUL iPeak Europium User manual

iPeak® Europium
Instructions for Use
Software Version 1.x
50008528-02
Revision Date: March 2023

Indication of the Introduced Modifications.................... 5
0. Glossary ................................................................... 6
1. Introduction................................................................. 7
1.1. Intended Use of the iPeak® Europium............................................................7
1.2. Target Population ...........................................................................................7
1.3. Product Classification .....................................................................................7
1.4. User Management..........................................................................................8
1.5. Device Description..........................................................................................8
1.6. Contraindications............................................................................................8
1.7. General Information........................................................................................9
1.7.1. Scope of Delivery.....................................................................................9
1.7.2. Technical Assistance.............................................................................10
1.7.3. Policy Statement....................................................................................10
1.7.4. Requirements for iPeak® Europium Users ............................................10
2. Safety Information .................................................... 11
2.1. Proper Use ...................................................................................................11
2.2. Electrical Safety............................................................................................12
2.3. Environment .................................................................................................14
2.4. Biological Safety...........................................................................................15
2.5. Chemicals.....................................................................................................16
2.6. Maintenance Safety......................................................................................16
2.7. Waste Disposal.............................................................................................17
2.8. Symbols on the iPeak® Europium Device.....................................................17
2.9. Cybersecurity................................................................................................19
3. General Description.................................................. 20
3.1. Device Overview...........................................................................................20
3.2. Accessories of the Device.............................................................................22
3.2.1. Drawer...................................................................................................22
3.2.2. External Power Supply ..........................................................................22
3.2.3. Power Cord............................................................................................22

3.2.4. Adjustment Drawer................................................................................22
4. Installation................................................................. 23
4.1. Unpack the Device........................................................................................23
4.2. Site Requirements........................................................................................23
4.3. Power Cable Connection..............................................................................24
4.4. Cassette Requirements ................................................................................24
5. Operating Procedures.............................................. 25
5.1. Login Screen ................................................................................................25
5.2. Home Screen Overview................................................................................26
5.3. Cassette Processing.....................................................................................27
5.4. System Menu................................................................................................35
5.4.1. System ..................................................................................................35
5.4.2. Cassette (Administrator Only)................................................................37
5.4.3. Preferences (Administrator Only)...........................................................38
5.4.4. Printer (Administrator or Manager Only) ................................................40
5.4.5. Network (Administrator or Manager Only)..............................................41
5.4.6. Versions ................................................................................................43
5.5. Side Menu ....................................................................................................43
5.5.1. Main Menu.............................................................................................44
5.5.2. Cassette Settings...................................................................................44
5.5.3. Scan Results .........................................................................................45
5.6. Tools Menu...................................................................................................50
5.6.1. System Menu.........................................................................................50
5.6.2. User Management –Change Password ................................................50
5.6.3. User Management - Users (Administrator or Manager)..........................51
5.6.4. Logout ...................................................................................................53
5.7. Software Update...........................................................................................54
5.8. Browser Generic Operations.........................................................................55

6. Troubleshooting ....................................................... 56
7. Maintenance.............................................................. 59
7.1. Cleaning Procedure......................................................................................59
7.2. Product Life ..................................................................................................59
Appendix A: Ordering Codes...................................... 60
Appendix B: Technical Data........................................ 61
Appendix C: Warranty ................................................. 63
Appendix D: Waste Electrical and Electronic
Equipment (WEEE)........................................................ 64
Appendix E: EU Declaration of Conformity................ 65
Appendix F: FCC Statement ....................................... 66
Appendix G: UK Declaration of Conformity ............... 67
Appendix H: RoHS Statement..................................... 68
Appendix I: Applied Standards.................................. 69

Doc. No 50008528-02
Page 5 of 70
INDICATION OF THE INTRODUCED MODIFICATIONS
If it’s the first time that you use iPeak® Europium, please read the entire document
carefully.
If it’s not the first time that you use iPeak® Europium and you use it before, in the table
below you can read the indication of the introduced modifications.
Revision
Description of change
02
Update section 2.8 “Symbols on the iPeak® Europium Device”
Update section 5.3 “Cassette Processing, section 5”
Update section 5.4.1 “System”
Update section 5.4.5 “Network”
Update section 5.5.3 “Scan results”
Update section 5.7 “Software update”
Update section 6 “Troubleshooting”
Update Appendix B: “Technical Data, section a. Specifications”
Update Appendix E “EU Declaration of Conformity”
New appendix G “UK Declaration of conformity”
Update Appendix H “Applied Standards”

Doc. No 50008528-02
Page 6 of 70
0. GLOSSARY
LFR - Lateral Flow Reader, it is a device such as iPeak® Europium that reads and
processes lateral flow tests.
Administrator - It is the most privileged user and has exclusive access to some options
of the LFR.
Manager - It is the second kind of privileged user and can manage users, printers, and
network setups of the LFR.
Operator- It is the person designated by the health organization to use the LFR for the
intended use.
LFR Configuration - Set of options that determine the behavior and functionalities of
the LFR. Most of them are only available by the Administrator user.
IUL’s partner - It is the institution, company, or other legal entity responsible to provide
the LFR together with the cassettes to the health organization. Moreover, the IUL’s
partner defines the necessary LFR’s configuration for the intended use environment
using the LFR’s Administrator user mode to update the LFR’s configuration when it is
necessary.
Health Organization - It is an institution, company, or other legal entity responsible to
operate the LFR together with the cassettes to be used in medical analysis of different
natures.
Cassette - It is a device that consists of lateral flow tests and a housing that contains
them.
Cassette Processing - The process that analyses lateral flow tests, from inserting a
cassette into an LFR, until the results are shown on the screen. This process includes
the scan of the cassette.
Cassette Model - It is the cassette housing, with a specific geometry that is adjusted in
the slot of a tailored drawer.
Cassette Type - It is the set of a cassette model and specific lateral flow tests contained
in its strips.
Cassette Settings - It is a set of parameters that enable the LFR to process and
measure a specific batch of a specific cassette type. Also referred to as “Cassette Type”,
“Cassette Configuration” and “Cassette Config.”.
Data Matrix - Barcode that contains the full information of one cassette settings. Also
referred to as “Configuration Barcode”.
Small-Data Matrix - Barcode that contains the cassette settings code and the batch ID.
It is used to confirm that the current cassette matches with the current cassette settings.
Also referred to as “Small Barcode” and “Confirm Cassette”.

Doc. No 50008528-02
Page 7 of 70
1. INTRODUCTION
Thank you for choosing the iPeak® Europium. We are confident that this instrument will
become an integral part of your laboratory.
Before using the iPeak® Europium, it is essential that you read these Instructions for Use
carefully. Following the instructions and safety information in this Instructions for Use will
ensure safe operation and maintain the system in a safe condition.
In case a serious incident occurred in relation to the device, it shall be reported to IUL
and the competent authority of the Member State in which the user and/or the patient is
established.
IUL SA, Carrer Ciutat d’Asunción 4, 08030 Barcelona, Spain.
Phone: [phone]
Email: su[email protected]m
1.1. Intended Use of the iPeak® Europium
The iPeak® Europium is an instrument specifically to be used to provide quantitative,
semi-quantitative, and/or qualitative in-vitro determination of fluorescence
immunochromatographic test defined and marketed by IUL’s partners.
The iPeak® Europium is intended to be used only in combination with lateral flow (LF)
tests indicated for use with the iPeak® Europium, and only for applications that are
described in the respective handbooks of our reader associates.
1.2. Target Population
The iPeak® Europium is intended to be used by trained qualified professional personnel
within a hospital setting or in an outpatient setting such as in a physician’s office. The
intended use does not include the operation of the device in intensive care units or in
operating theatres unless all specific hygiene and patient safety requirements of these
locations are followed by the user.
1.3. Product Classification
According to Regulation (EU) 2017/746, iPeak® Europium is classified as CLASS A thus
only an EU Declaration of Conformity and CE Marking are required.
According to US Food and Drugs Administration (FDA) requirements, iPeak® Europium
is classified as CLASS I and it is exempted from the premarket notification requirement
thus only an Establishment Registration and a Medical Device listing are required.

Doc. No 50008528-02
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1.4. User Management
The iPeak® Europium can be used in three different roles:
- Operator: have access to the features needed when operating.
- Manager: have access to features needed when operating, plus the network
and connectivity feature. It can also delete scanned results.
- Administrator: have unlimited access to every feature of the iPeak® Europium
Device Description
1.5. Device Description
A portable fluorescence test reader that yields qualitative, semi-quantitative, and
quantitative results for the cassettes that are marketed by IUL’s partner.
The iPeak® Europium Cassette Designer application for personal computer enables
IUL’s partner to define and assess the settings required to process each cassette
supported by the LFR.
1.6. Contraindications
Not applicable.