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

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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”

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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”.

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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.

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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.

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1.7. General Information
1.7.1. Scope of Delivery
The delivery includes the following items:
1. iPeak® Europium main unit (Cat. 100035000)
2. Drawer (Customized for each IUL’s Partner Cat. 9000xxxxx)
3. Adjustment drawer (Cat. 900013860)
4. External power supply unit (Cat. 900020089)
5. Power cord (Cat. 900020080 or Cat. 900020090)
See Ordering Codes for more information.
1
2
4
5
3

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1.7.2. Technical Assistance
At IUL SA we pride ourselves on the quality and availability of our technical support. Our
Technical Service Department is staffed by experienced technicians with extensive
practical and theoretical expertise in the use of IUL SA products. If you have any
questions or experience any difficulties regarding the iPeak® Europium or IUL SA
products in general, do not hesitate to contact us.
Phone: [phone]
Email: [e-mail]
IUL SA customers are a major source of information regarding advanced or specialized
uses of our products. This information is helpful to other customers as well as to the
researchers at IUL SA. We, therefore, encourage you to contact us if you have any
suggestions about product performance or new applications and techniques.
For technical assistance, contact the IUL SA Technical Service Department or local
distributors. Email: [e-mail]
1.7.3. Policy Statement
It is the policy of IUL SA to improve products as new techniques and components
become available. IUL SA reserves the right to change the specifications of products at
any time.
In an effort to produce useful and appropriate documentation, we appreciate your
comments on these Instructions for Use. Please contact IUL SA Technical Service with
any feedback.
1.7.4. Requirements for iPeak® Europium Users
Table 1 covers the general level of competence for the use and servicing of the iPeak®
Europium.
Task
Personnel
Training and experience
Routine use
Laboratory
technicians
or equivalent
Trained in techniques included in each
cassette.
Servicing
Service
Specialists only
Trained, certified, and authorized by IUL
SA.

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2. SAFETY INFORMATION
Before using the iPeak® Europium, it is essential that you read these Instructions for Use
carefully. Following the instructions and safety information in these Instructions for Use
will ensure safe operation and maintain the system in a safe condition.
The following types of safety information appear throughout the iPeak® Europium
Instructions for Use.
WARNING
The term WARNING together with the symbol is used to inform you
about situations that could result in personal injury to you or other
persons.
Details about these circumstances are given in a box like this one.
CAUTION
The term CAUTION is used to inform you about situations that could
result in damage to the instrument or other equipment.
Details about these circumstances are given in a box like this one.
The advice given in this Instructions for Use is intended to supplement, not supersede,
the normal safety requirements prevailing in the user’s country.
2.1. Proper Use
WARNING/
CAUTION
Risk of personal injury and material damage
Improper use of the iPeak® Europium instrument may cause
personal injury or damage to the instrument.
The instrument must only be operated by qualified personnel.
CAUTION
Damage to the instrument
Avoid spilling water or chemicals onto the iPeak® Europium
instrument. Damage caused by water or chemical spillage will void
your warranty.
In case of emergency, switch off the iPeak® Europium with the power button and unplug
the power cord from the power outlet.

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2.2. Electrical Safety
If the operation of the iPeak® Europium is interrupted in any way (e.g., due to interruption
of the power supply or a mechanical error), first unplug the power cord from the power
outlet, then switch off the instrument using the power button. Contact IUL SA Technical
Service after such an incident.
WARNING
Rechargeable Batteries
The iPeak® Europium has a battery pack inside that accomplishes
the IEC 62133 standard: Secondary cells and batteries containing
Alkaline or other Non-Acid Electrolytes –safety requirements for
portable sealed secondary cells and for batteries made from them,
for use in portable applications.
This WARNING is applicable to routine users as well as to technical
service users.
•Do not dismantle, open or shred batteries.
•Keep batteries out of the reach of children.
•Seek medical advice immediately if a battery has been
swallowed.
•Do not expose batteries to heat or fire. Avoid storage in direct
sunlight.
•Do not remove a battery from its original packaging.
•Do not subject batteries to mechanical shock
•In event of a cell leaking, do not allow the liquid comes in
contact with the skinor eyes. If contact has been made, wash
the affected area with copious amounts of water and seek
medical advice.
•Only use Batteries provided by IUL SA.
•After a storage period of 6 months, it is necessary to charge
the batteries to obtain maximum performance.

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WARNING
Electrical hazard
Any interruption of the protective conductor (earth/ground lead)
inside or outside the instrument or disconnection of the protective
conductor terminal is likely to make the instrument unsafe. This
must be checked after service or maintenance.
Intentional interruption is prohibited.
Lethal voltages inside the instrument
This WARNING is applicable to routine users as well as to technical
service users.
•Risk of electrical shock and energy hazard. All failures should be
examined by a qualified technician. Please do not remove the
case of the AC adaptor by yourself!
•Adaptors should be placed on a reliable surface. A drop or fall
could cause damage.
•Please do not place the AC adaptor in places with high moisture
or near the water.
•Please do not place the AC adaptor in places with high ambient
temperature or near a fire source. About the maximum ambient
temperature, please refer to “Appendix B: Technical Data”.
•Disconnect the AC adaptor from the AC power before cleaning.
Do not use any liquid or aerosol cleaner. Only use a damp cloth
to wipe it.
•In case of replacement or a loosing of the AC adaptor or the
mains power cord, these must be replaced only with the AC
adaptors or power cords listed in “Ordering Codes”In case of
replacement, this must be ordered to IUL SA.
To ensure the satisfactory and safe operation of the iPeak® Europium:
•The power cord of the external power supply must be connected to a line power
outlet that has a protective conductor (earth/ground).
•No other external power supply neither power cords than the specified in
“Ordering Codes” must be used. In case of replacement, this must be ordered
from IUL SA.
•The instrument must not be operated with the cover removed.
•If you suspect any instrument damage, contact IUL SA Technical Service.
If the iPeak® Europium becomes electrically unsafe, prevent other personnel from
operating it, and contact IUL SA Technical Service.

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The instrument may be electrically unsafe if:
•The instrument or the external power supply is shown to be damaged.
•The instrument has been stored under unfavorable conditions for a prolonged
period.
•A different external power supply is used other than the one provided by IUL SA’s
partner.
WARNING
Risk of electric shock
In case of replacement or loss of the external power supply or the
power cord, these must be replaced only with the external power
supply or power cords listed in “Ordering Codes”and provided by
IUL SA’s partner.
2.3. Environment
Operating conditions
WARNING
Explosive atmosphere
The iPeak® Europium is not designed for use in an explosive
atmosphere.
CAUTION
High humidity or liquids
Protect the iPeak® Europium from high humidity and contact with
liquids.
CAUTION
Dirty environment
Ensure that the inlet air filter does not clog, by cleaning or replacing
it frequently.
CAUTION
Strong electromagnetic radiation
Do not expose the iPeak® Europium to strong electromagnetic
radiation.
CAUTION
Strong ultrasonic radiation
Do not expose the iPeak® Europium to strong ultrasonic radiation.

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2.4. Biological Safety
Use safe laboratory procedures as outlined in publications such as Biosafety in
Microbiological and Biomedical Laboratories, HHS:
https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-
2009-P.PDF
WARNING
Samples containing infectious agents
Some samples used with the iPeak® Europium may contain
infectious agents. Handle such samples in accordance with the
required safety regulations.
Always read how to proceed in the cassette’s instructions of use.
The responsible person(s) (e.g., laboratory manager) must take the
necessary precautions to ensure that the workplace is safe and that
the instrument operators are suitably trained and not exposed to
hazardous levels of infectious agents, as defined in the applicable
Safety Data Sheets (SDSs) or OSHA 1ACGIH 2or COSHH 3
documents.
Venting of fumes and disposal of wastes must be in accordance with
all national, state, and local health and safety regulations and laws.
WARNING
Samples containing infectious agents
Use safe laboratory procedures as outlined in publications such as
Biosafety in Microbiological and Biomedical Laboratories, HHS:
https://www.cdc.gov/labs/pdf/CDC-
BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF
See: Section III—Principles of Biosafety
Laboratory Practices and Technique
The most important element of containment is strict adherence to
standard microbiological practices and techniques. Persons working
with infectious agents or potentially infected materials must be aware
of potential hazards and must be trained and proficient in the
practices and techniques required for handling such material safely.
The director or person in charge of the laboratory is responsible for
providing or arranging the appropriate training of personnel.
1
OSHA: Occupational Safety and Health Administration (United States of America).
2
ACGIH: American Conference of Government Industrial Hygienists (United States of America).
3
COSHH: Control of Substances Hazardous to Health (United Kingdom).

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WARNING
Samples containing infectious agents
To avoid hazards in case of cassette break use Primary Barriers and
Personal Protective Equipment:
Use safe laboratory procedures as outlined in publications such as
Biosafety in Microbiological and Biomedical Laboratories, HHS:
https://www.cdc.gov/labs/pdf/CDC-
BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF
See: Section III—Principles of Biosafety
Safety Equipment (Primary Barriers and Personal Protective
Equipment)
Safety equipment includes BSCs, enclosed containers, and other
engineering controls designed to remove or minimize exposures to
hazardous biological materials.
2.5. Chemicals
WARNING
Hazardous chemicals
Some chemicals used with the iPeak® Europium may be hazardous.
Always wear safety glasses, gloves, and a lab coat.
The responsible person(s) (e.g., laboratory manager) must take the
necessary precautions to ensure that the workplace is safe and that
the instrument operators are suitably trained and not exposed to
hazardous levels of toxic substances (chemical or biological), as
defined in the applicable Safety Data Sheets (SDSs) or OSHA,
ACGIH or COSHH documents.
Venting of fumes and disposal of wastes must be in accordance with
all national, state, and local health and safety regulations and laws.
2.6. Maintenance Safety
CAUTION
Damage to the instrument
Do not use spray bottles containing alcohol or disinfectant to clean
the surface of the iPeak® Europium instrument.
Do not use products containing alcohol or other corrosive solvents
to clean the iPeak® Europium instrument.
WARNING
Risk of electric shock
Do not open the panels on the instruments.
Risk of personal injury and material damage
Only perform maintenance that is specifically described in this
Instructions for Use.

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2.7. Waste Disposal
Used consumables, such as cassettes, may contain hazardous chemicals or infectious
agents. Collect and dispose of them following local safety regulations.
All packaging waste from cassettes must be collected and disposed of properly following
local environmental regulations.
For disposal of waste electrical and electronic equipment (WEEE) see “Waste Electrical
and Electronic Equipment (WEEE)”.
2.8. Symbols on the iPeak® Europium Device
Symbol
Location
Description
Type plate on the
bottom of the
instrument and the
external box label
CE Mark, Declaration of Conformity, see
“EU Declaration of Conformity”.
Type plate on the
bottom of the
instrument and the
external box label
Medical device manufacturer.
Type plate on the
bottom of the
instrument and the
external box label
The device is intended to be used as an in
vitro medical device.
Type plate on the
bottom of the
instrument and the
external box label
Date of manufacture.
Type plate on the
bottom of the
instrument and the
external box label
Catalog Number.
Type plate on the
bottom of the
instrument and the
external box label
Serial Number.
Label on the side of
the external box
Indicates a carrier that contains unique
device identifier information
Label on the side of
the external box
Temperature limits, see ”Appendix B:
Technical Data”.

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Symbol
Location
Description
Label on the side of
the external box
Humidity limits, see ”Appendix B: Technical
Data”.
Only in the cassettes
that have a
biological hazard
(information on the
cassettes’
instructions for use)
Biological hazard symbol.
Type plate on the
bottom of the
instrument and the
external box label
Consult instructions for use.
Type plate on the
bottom of the
instrument
Caution is necessary when operating the
device.
Label on the side of
the external box
All components of the instrument are
recyclable.
On the bottom of the
drawer
Identify the material the drawer is made of
(Polyamide).
Type plate on the
bottom of the
instrument and the
external box label
Waste Electrical and Electronic Equipment
(WEEE), see “Waste Electrical and
Electronic Equipment (WEEE)”.
Type plate on the
bottom of the
instrument and the
external box label
FCC compliant, Declaration of Conformity,
see “EU Declaration of Conformity”.
Type plate on the
bottom of the
instrument and the
external box label
Caution: Federal law restricts this device to
sale by or on the order of a physician.
Type plate on the
bottom of the
instrument and the
external box label1
UKCA Mark, Declaration of Conformity, see
“Appendix G: UK Declaration of Conformity
”
1
The UKCA symbol on the external box label will be included only for shipments to the United Kingdom