IUL iPeak Europium Instructions For Use Manual
  1. Manuals
  2. Brands
  3. IUL Manuals
  4. Measuring Instruments
  5. iPeak Europium
  6. Instructions for use manual

IUL iPeak Europium Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

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

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the iPeak Europium and is the answer not in the manual?

Questions and answers

Related Manuals for IUL iPeak Europium

Summary of Contents for IUL iPeak Europium

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

  • Page 3: Table Of Contents

    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 ..................
  • Page 4 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.
  • Page 5 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) ............

  • Page 7: Indication Of The Introduced Modifications

    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.

  • Page 8: Glossary

    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...

  • Page 9: Introduction

    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.

  • Page 10: User Management

    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.

  • Page 11: 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.

  • Page 12: Technical Assistance

    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®...

  • Page 13: Safety Information

    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®...

  • Page 14: 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.
  • Page 15 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.

  • Page 16: Environment

    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. Risk of electric shock In case of replacement or loss of the external power supply or the...

  • Page 17: Biological Safety

    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 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.

  • Page 18: Chemicals

    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: WARNING 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...

  • Page 19: Waste Disposal

    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)”.
  • Page 20 Symbol Location Description Humidity limits, see ”Appendix B: Technical Label on the side of the external box Data”. Only in the cassettes that have a biological hazard Biological hazard symbol. (information on the cassettes’ instructions for use) Type plate on the bottom of the Consult instructions for use.

  • Page 21: Cybersecurity

    All the cybersecurity controls are integrated into the SW storage, including SW integrity verification, firewall, or others. The LFR is designed to operate in the intended environment of use defined by IUL’s partner. The LFR’s partner is the legal entity that defines the setup for a specific intended environment of use, including LFR’s setup and operation process.

  • Page 22: General Description

    3. GENERAL DESCRIPTION 3.1. Device Overview FRONT-BOTTOM VIEW: 1. Touchscreen and display 2. Drawer insertion slot 3. Barcode reader 4. Air inlet Doc. No 50008528-02 Page 20 of 70...
  • Page 23 REARVIEW: 5. Power button and Power ON indicator (white LEDs) 6. Ethernet socket 7. External power supply socket 8. Battery in charge red LED 9. Air outlet 10. Software Wipe buttonhole 11. USB host port (only accessible for slim USB memory sticks) WARNING For proper insertion of a slim USB memory stick, its body section near the connector must be 8,5x16mm or less.

  • Page 24: Accessories Of The Device

    In case of replacement or loss of the external power supply, this must be replaced only with one of the power cords listed in “Ordering Codes” delivered by IUL SA. 3.2.3. Power Cord The LFR is equipped with a power cord with a plug suitable for the destination country.

  • Page 25: Installation

    4. INSTALLATION 4.1. Unpack the Device The packaging of the iPeak® Europium can be stored for reuse. CAUTION Before switching on the reader for the first time or after a long period of inactivity, it is essential to plug it into the mains supply. Failure to do so may cause permanent damage to the unit.

  • Page 26: Power Cable Connection

    4.3. Power Cable Connection The socket for connecting the power cable is on the back of the iPeak® Europium device. When the iPeak® Europium is not in use for a long period of time, we recommend disconnecting the power cable. 4.4.

  • Page 27: Operating Procedures

    5. OPERATING PROCEDURES CAUTION Before switching on the reader for the first time or after 6 months of inactivity, it is essential to plug it into the mains supply. Failure to do so may cause permanent damage to the unit. 5.1.

  • Page 28: Home Screen Overview

    5.2. Home Screen Overview The Home screen displays the current Cassette Settings, date, time, battery status, the device’s internal temperature, the ‘NEW SCAN’ button, and the ‘SYSTEM MENU’ button. Main Screen: Press this button to start a new Cassette Processing. Press this button to enter the System Menu.

  • Page 29: Cassette Processing

    5.3. Cassette Processing To process a cassette, the next steps should be followed: 1- To start a new cassette scan, press the ‘NEW SCAN’ button on the Home screen (see red circle). 2- Omit this step if the Cassette Settings on the Top Bar is the Cassette Settings to use in the next scan.
  • Page 30 Take the Data Matrix of proper Cassette Settings, which is supplied along with the cassette box: Place it in front of the LFR’s barcode reader (see section 3.1) at 5 cm of distance approximately. Press the ‘ACTIVATE BARCODE READ’ button (see green circle).
  • Page 31 Press the ‘SELECT AS CURRENT’ button to load the corresponding Cassette Settings. B.2 ‘Barcode Autodetection’ launches directly the scan if the option ‘Barcode Autodetection’ is selected by the IUL’s partner. The LFR will automatically load the proper Cassette Settings if it is WARNING...
  • Page 32 Place the small barcode (Small-Data Matrix) in front of the barcode reader (see section 3.1) at 5 cm of distance approximately. Press the ‘ACTIVATE BARCODE READ’ button (see orange circle). The barcode reader starts its reading process using a light. This light disappears when a barcode has been read or after 10 seconds of trying.
  • Page 33 After typing an identification text on the virtual keyboard, press the ‘Enter’ button (see the orange circle on the left-side image) to proceed. To load the identification text from a barcode, press the ‘ACTIVATE BARCODE READ’ button (see the red circle on the following right-side image) and place the barcode in front of the frontal light.
  • Page 34 Before launching a scan: - Ensure that the four (4) white dots (fiducials) on top of the drawer are present, undamaged, clean (see section 7.1), and round (e.g., in its original factory condition). WARNING - Ensure that strips embedded in the cassette are free of impurities such as fiber or dust.
  • Page 35 6- Two options are available to scan a cassette: (1) If you have already waited the prescribed time after inoculating the sample into the cassette, press the ‘SCAN’ button (see red circle) to scan the cassette immediately. (2) If you have just inoculated the sample into the cassette, press the ‘TIMED SCAN’...
  • Page 36 The reader will provide reliable results as long as the tests are WARNING running according to the IUL’s partner specifications, the control and test lines are differentiated from the background, as well as the cassette does not present artifacts or impurities such as hair or dust.

  • Page 37: System Menu

    5.4. System Menu Set the configuration through this menu. Different tabs are available, depending on the user’s role. 5.4.1. System All users can access this screen. NOTE: Depending on the configuration some items are not displayed. • Language: Select one language among those installed in the LFR. •...
  • Page 38 • Set Date/Time: Define the current date and time. This parameter has configurable access. NOTE: It is IUL’s Partner responsibility to keep the LFR’s date and time properly set. • Set Time Zone: Define the current time zone. WARNING After changing Time Zone, re-start the LFR.

  • Page 39: Cassette (Administrator Only)

    5.4.2. Cassette (Administrator Only) Only the user “admin” (role Administrator) can access this screen. Parameters related to Cassette Settings are displayed and could be edited: • Cassette Settings Version: This parameter is used to accept or block some Cassette Settings depending on its configuration. This is an internal parameter of the LFR, but Cassette Settings also has a parameter called Cassette Settings Version.

  • Page 40: Preferences (Administrator Only)

    Small Barcode → The confirmation barcode (Small-Data Matrix) must be read before each scan, to confirm that the current cassette matches the current Cassette Settings. Barcode Autodetection → After launching a scan (with ‘SCAN’ or ‘TIMED SCAN’ buttons), the device tries to find the Cassette Settings that match with one of the Cassette Settings list, reading the barcode embedded on the cassette.
  • Page 41 • Sample ID Checking: Four ID checking levels are available: ‘No Check’, ‘Required’, ‘Warn if Duplicate’, and ‘Block if Duplicate’. → No Check There are no restrictions or warnings. → Required A value is mandatory. → Warn if Duplicate A value is mandatory, and a warning is displayed if the current value is in the LFR’s stored results.

  • Page 42: Printer (Administrator Or Manager Only)

    (see section 5.4.1). When SFTP export is enabled, the Scan Results list displays an SFTP status for each scan and a 'RETURN SFTP' button when necessary (see section 5.5.3). NOTE: Contact IUL SA to request technical specifications of Remote Export or SFTP Export functionalities: Phone: +34 932 740 232; Email: iul@iul-inst.com 5.4.4.

  • Page 43: Network (Administrator Or Manager Only)

    The ticket printer MUST support ESC/P control language, and there are two options: A- Ticket printer with serial port, and an external USB to the serial port adaptor. B- Ticket printer with USB port, internally emulating serial port. 5.4.5. Network (Administrator or Manager Only) Only users with the Administrator’s or Manager’s roles can edit the parameters of this screen.
  • Page 44 • Ethernet: Displays current Ethernet configuration. Press its SET button to configure it. With the option ‘DHCP Client’ (default), the network server assigns network parameters to LFR. If the option ‘Static’ is selected the connection parameters must be set on the LFR (specifically: IP, Mask, and Gateway).

  • Page 45: Versions

    5.4.6. Versions Displays a list of information related to the LFR and its software. • Model: It is related to the product number (see bottom label). Determines the compatibility of cassette settings and it is related to Cassette Settings Version functionalities.

  • Page 46: Main Menu

    5.5.1. Main Menu Returns to the Home screen. 5.5.2. Cassette Settings The available Cassette Settings list is displayed. After pressing one ‘SELECT AS CURRENT’ button (see orange circle) the corresponding Cassette Settings will be displayed on the Top Bar and it will be ready to use. Press on a row (see red circle) to access each Cassette Settings screen.

  • Page 47: Scan Results

    5.5.3. Scan Results Access the list of stored scan results. The list is ordered with the most recent scan on top and a maximum of 5 results are shown on each page. Drag up and down on the touchscreen to displace the list of the results and press on each one to explore the result. Swipe left to return to the list results.
  • Page 48 • SFTP state (only in case of enabling SFTP service) Each SFTP state could have the following values: • Pending: Sending data is ongoing. As well as if the scan was performed with the SFTP service disabled. • Success: Scan data has been properly sent. •...
  • Page 49 • COMMENTS: Open space to add comments to this scan result. • INFO: Displays data related to the scan process. Available buttons: • PRINT TICKET: If a ticket printer is connected and properly configured, press the ‘PRINT TICKET’ button to obtain a ticket/label containing the identification data and the summary results of the scan.
  • Page 50 B- EXPORT RESULTS BUTTON After pressing the ‘Export Results’ button (see red circle) from the Scan Results screen a pop-up dialog is displayed to select export options. Before pressing the ‘OK’ button a slim USB memory stick (previously formatted as described in section 5.4.1) should be plugged into the USB host port (see section 3.1).
  • Page 51 • In the case of a strip where the Control line is not found, no rows corresponding to Test lines are present (because they cannot be evaluated if the Control line is missing). Parameters included in the results (for each processed line): NOTE: Some fields will not appear if you have logged in with Manager or Operator role.

  • Page 52: Tools Menu

    5.6. Tools Menu Pressing the gear symbol on the center-right of the Top Bar, a dropdown menu is displayed, with the following options: 5.6.1. System Menu Explained in section 5.4.1. 5.6.2. User Management – Change Password This screen allows password change. As Administrator or Manager, a ‘Username’...

  • Page 53: User Management - Users (Administrator Or Manager)

    As Operator, to change the password, type the current password in the ‘Current Password’ field and type the new password in both the ‘New Password’ and the ‘Confirm New Password’ fields. After editing all fields, press the ‘SAVE’ button: • ‘Password If the LFR displays the green message: Changed!’, the...
  • Page 54 A- CREATE NEW USER To create a new user, select the first item of the ‘Username’ list, ‘Create new user’, and fill the fields available. Only the ‘Username’, ‘Password’, and ‘User Role’ fields are mandatory. Press the ‘SAVE’ button and then the ‘CONFIRM’ button from the pop-up dialog to store the new user account.

  • Page 55: Logout

    B- EDIT or DELETE AVAILABLE USER To edit or delete a user account, select the user on the ‘Username’ drop-down list. Press each field to edit its value using a virtual keyboard. To save changes press the ‘SAVE’ button and then the ‘CONFIRM’ button from the pop-up dialog. To delete the selected user, press the ‘DELETE’...

  • Page 56: Software Update

    Run this procedure under Technical Support advice and with a full charge of the battery and plug LFR into the mains supply. To update the Software, follow these steps (under IUL’s partner supervision if you do not have an Administrator role): •...

  • Page 57: Browser Generic Operations

    5.8. Browser Generic Operations Here are some tips to browse the iPeak® Europium : • Return to the previous screen by swiping left. • Remove an error message from the screen by touching the screen outside the error. • Depending on the selected field, the virtual keyboard is displayed: For Username(user), Password(user), Sample/patient ID, Comments, Name, Surname, and Department: a / A d / D g / G...

  • Page 58: Troubleshooting

    6. TROUBLESHOOTING Symptom Probable cause Recommended action Plug the Power supply unit to The unit cannot turn ON Battery discharged recharge The LFR cannot turn ON or turn Contact the Technical Service Damage to the ON/OFF button for repair Too much time of inactivity Increase the inactivity time in unit switches...
  • Page 59 Symptom Probable cause Recommended action There dirtiness Clean it with an antistatic cloth barcode reader window or a brush The USB stick is too wide, narrow-width preventing proper full memory stick insertion into the socket Format the USB memory stick properly using the option in the System The LFR cannot access the...
  • Page 60 Symptom Probable cause Recommended action Press and hold the power button Electrostatic discharge on the for 10 seconds. Press the power The device does not respond touchscreen button again to power on the device The unit cannot turn ON the Damage in the Power ON Contact the Technical Service Power...

  • Page 61: Maintenance

    The iPeak® Europium can run for 5 years from the manufacturing date indicated in the iPeak® Europium label. It is the responsibility of the final user and not IUL SA to use the device beyond this date. If the iPeak® Europium is used as a POC (“point of care") that needs to be recharged more than once per week, it could have an impact on the capacity of the battery with a lower useful life.

  • Page 62: Appendix A: Ordering Codes

    APPENDIX A: ORDERING CODES Spare Parts Product Contents Cat. # Customized Drawer 1 unit 9000xxxxx iPeak® Eurorpium self-adjusting 1 unit 900013860 light drawer Air filter 1 unit 900013937 External power supply 1 unit 900020089 Power cord Schuko 1 unit 900020090 Power cord (USA / Japan) 1 unit 900020080...

  • Page 63: Appendix B: Technical Data

    50Hz-60Hz) Maximum power 40 W Overvoltage category Environment temperature 20 ~ 25 ºC In lines with an intensity around the middle of the dynamic range measured on the IUL’s Quality Control pattern. Doc. No 50008528-02 Page 61 of 70...
  • Page 64 Relative humidity 10 ~ 75 % (non-condensing) Altitude Up to 2000 meters (6500ft.) Place of operation For indoor use only Pollution level Transportation Conditions Environment temperature 5ºC ~ 40ºC (41ºF ~ 104ºF) In manufacturer’s packaging Relative humidity Maximum 75 % (non-condensing) Storage Conditions Environment temperature 5ºC ~ 40ºC (41ºF ~ 104ºF)

  • Page 65: Appendix C: Warranty

    APPENDIX C: WARRANTY The IUL SA instrument has a 12-month warranty period. The warranty is void when misuse of the equipment can be proved. Damage or faults caused by impacts, chemical or corrosive products, liquids, damp, or other external factors, such as radiation, fire, or inadequate transport are not included.

  • Page 66: Appendix D: Waste Electrical And Electronic Equipment (Weee)

    APPENDIX D: WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) This appendix provides information about the disposal of waste electrical and electronic equipment by users. The crossed-out wheeled bin symbol (see below) indicates that this product must not be disposed of with other waste; it must be taken to an approved treatment facility or to a designated collection point for recycling, according to local laws and regulations.

  • Page 67: Appendix E: Eu Declaration Of Conformity

    2017 on in vitro diagnostic medical devices. Barcelona, October the 14 2022 _________________________ ____________________________ Vicenç Font David Guerrero (IVD Technical Manager) (Quality Manager) Generic reference, current version of this EU Declaration of conformity available in IUL internal document 50008558. Doc. No 50008528-02 Page 65 of 70...

  • Page 68: Appendix F: Fcc Statement

    APPENDIX F: FCC STATEMENT FCC Declaration of Conformity Responsible party: IUL SA C/ Ciutat d’Asunción 4 08030 Barcelona Spain This device: − Contains TX FCC ID:2ABCB-RPI4B − Contains IC: 20953-RPI4B − Complies with Part 15 of FCC Rules, Operation is Subject to the following two...

  • Page 69: Appendix G: Uk Declaration Of Conformity

    • EN 62304:2006 - Medical device software - Software life-cycle processes Barcelona, October the 24 2022 _____________________________ __________________________ Vicenç Font David Guerrero (IVD Technical Manager) (Quality Manager) Generic reference, current version of this UK Declaration of conformity available in IUL internal document 50008514. Doc. No 50008528-02 Page 67 of 70...

  • Page 70: Appendix H: Rohs Statement

    APPENDIX H: ROHS STATEMENT The following information has been made available to comply with The Restriction of Hazardous Substances Directive, (RoHS2 & RoHS3), short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

  • Page 71: Appendix I: Applied Standards

    APPENDIX I: APPLIED STANDARDS The iPeak® Europium Lateral Flow Reader is in conformity with the following standards: • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes • CFR21 PART 820 Quality System Regulation • EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 1: General requirements •...
  • Page 72 Notes Doc. No 50008528-02 Page 70 of 70...
  • Page 76 © 2023 IUL SA All rights reserved...

Table of Contents