IUL iPeak Plus User manual

iPeak® Plus
Instructions for Use
Software Version 3.x
50008329-05
Revision Date: January 2023

INDICATION OF THE INTRODUCED MODIFICATIONS .. 5
0. GLOSSARY.................................................................. 6
1. INTRODUCTION .......................................................... 7
Intended Use of the iPeak® Plus ....................................................................7
Target Population ...........................................................................................7
Product Classification .....................................................................................7
User Management ..........................................................................................7
Device Description..........................................................................................8
Contraindications............................................................................................8
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® Plus users ..................................................... 10
2. SAFETY INFORMATION ........................................... 11
Proper Use ...................................................................................................11
Electrical Safety............................................................................................12
Environment .................................................................................................14
Biological Safety ...........................................................................................15
Chemicals.....................................................................................................16
Maintenance Safety......................................................................................16
Waste Disposal.............................................................................................17
Symbols on the iPeak® Plus Device............................................................. 18
Cybersecurity................................................................................................20
3. GENERAL DESCRIPTION......................................... 21
Device Overview...........................................................................................21
Accessories of the Device............................................................................. 23
3.2.1. Drawer................................................................................................... 23
3.2.2. External power supply ........................................................................... 23
3.2.3. Power cord ............................................................................................ 23

3.2.4 Adjustment Drawer ................................................................................23
4. INSTALLATION.......................................................... 24
Unpack the Device........................................................................................24
Site Requirements ........................................................................................24
Power Cable Connection ..............................................................................24
Cassette Requirements ................................................................................24
5. OPERATING PROCEDURES .................................... 25
Login Screen ................................................................................................ 25
Home Screen Overview................................................................................ 26
Cassette Processing.....................................................................................27
System Menu................................................................................................ 34
5.4.1. System ..................................................................................................34
5.4.2. Cassette (Administrator only)................................................................. 35
5.4.3. Preferences (Administrator ONLY) ........................................................37
5.4.4. Printer (Administrator or Manager only) ................................................. 39
5.4.5. Network (administrator or manager only)...............................................40
5.4.6. Versions ................................................................................................41
Side Menu .................................................................................................... 42
5.5.1. Main Menu............................................................................................. 42
5.5.2. Cassette Settings ..................................................................................42
5.5.3. Scan Results .........................................................................................44
Tools Menu................................................................................................... 49
5.6.1. System Menu.........................................................................................49
5.6.2. User Management –Change Password ................................................ 49
5.6.3. User Management - Users (Administrator or Manager only) ..................50
5.6.4. Logout ...................................................................................................52
Software Update...........................................................................................52
Browser Generic Operations.........................................................................53

6. TROUBLESHOOTING ............................................... 54
7. MAINTENANCE ......................................................... 56
Cleaning Procedure...................................................................................... 56
Product Life .................................................................................................. 56
APPENDIX A: ORDERING CODES ................................. 57
Spare Parts ............................................................................................................. 57
Optional Accessories............................................................................................... 57
APPENDIX B: TECHNICAL DATA................................... 58
Specifications..........................................................................................................58
Connectivity.............................................................................................................58
Operating Conditions............................................................................................... 58
Transportation conditions ........................................................................................59
Storage conditions...................................................................................................59
Dimensions and Weight ..........................................................................................59

APPENDIX C: WARRANTY ............................................. 60
APPENDIX D: WASTE ELECTRICAL AND ELECTRONIC
EQUIPMENT (WEEE) ....................................................... 61
APPENDIX E: EU DECLARATION OF CONFORMITY ... 62
APPENDIX F: FCC STATEMENT .................................... 63
APPENDIX G: UK DECLARATION OF CONFORMITY... 64
APPENDIX H: ROHS STATEMENT ................................. 65
APPENDIX I: APPLIED STANDARDS ........................... 66

Doc. No 50008329-05
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INDICATION OF THE INTRODUCED MODIFICATIONS
If it’s the first time that you use iPeak® Plus, please read the entire document carefully.
If it’s not the first time that you use iPeak® Plus and you use it before, in the table below
you can read the indication of the introduced modifications.
Document
Revision
Description of changes
04
Updating section 5 “Operation procedures”

Doc. No 50008329-05
Page 6 of 67
0. GLOSSARY
LFR - Lateral Flow Reader, it is a device such as iPeak® Plus that reads and processes
immunochromatographic 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 behaviour and functionalities of
the LFR. Most of them 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
nature.
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 specific cassette type. Also referred to as “Test Name”,
“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 current cassette settings. Also
referred to as “Small Barcode” and “Confirm Cassette”.

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1. INTRODUCTION
Thank you for choosing the iPeak® Plus. We are confident that this instrument will
become an integral part of your laboratory.
Before using the iPeak® Plus, it is essential that you read this 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: suppo[email protected]om
Intended Use of the iPeak® Plus
The iPeak® Plus is an instrument specifically to be used to provide quantitative, semi-
quantitative, and/or qualitative in-vitro determination of photometric
immunochromatographic test defined and marketed by IUL’ partners.
The iPeak® Plus is intended to be used only in combination with lateral flow (LF) tests
indicated for use with the iPeak® Plus, and only for applications that are described in the
respective handbooks of our reader associates.
Target Population
The iPeak® Plus 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.
Product Classification
According to Regulation (EU) 2017/746, iPeak® Plus 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® Plus 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.
User Management
The iPeak® Plus 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.

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- Administrator: have unlimited access to every feature of the iPeak® Plus
Device Description
A portable test reader that yields qualitative, semi-quantitative, and quantitative results
for the cassettes that are marketed by IUL’s partner.
The iPeak® Development Software for personal computers enables IUL’s partner to
define and assess the settings required to process each cassette supported by the LFR.
Contraindications
Not applicable.