IUL iPeak 900033000 Instructions For Use Manual
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IUL iPeak 900033000 Instructions For Use Manual

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iPeak® reader 4,3"
Instructions for Use
Software Version 3.x
Doc. 50008314-10
Revision Date: November 2023

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Summary of Contents for IUL iPeak 900033000

  • Page 1 iPeak® reader 4,3” Instructions for Use Software Version 3.x Doc. 50008314-10 Revision Date: November 2023...

  • Page 3: Table Of Contents

    Indication of the Introduced Modifications ......5 0. Glossary ................ 6 1. Introduction ..............7 Intended Use of the iPeak® reader 4,3” ..............7 Target Population ....................7 Product Classification .................... 7 User Management ....................7 Device Description ....................8 Contraindications ....................
  • Page 4 3.2.2. External Power Supply ..................22 3.2.3. Power Cord...................... 22 3.2.4. Adjustment Drawer ..................22 4. Installation..............23 Unpack the Device ....................23 Site Requirements ....................23 Power Cable Connection ..................23 Cassette Requirements ..................23 5. Operating Procedures ........... 24 Login Screen .......................
  • Page 5 6. Troubleshooting ............55 7. Maintenance ..............58 Cleaning Procedure ..................... 58 Product Life ......................58 Appendix A: Ordering Codes ........... 59 Appendix B: Technical Data ..........60 Appendix C: Warranty ............62 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® reader 4,3”, please read the entire document carefully. If it’s not the first time that you use iPeak® reader 4,3” 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

    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.

  • Page 10: 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 computer enables IUL’s partner to define and assess the settings required to process each cassette supported by the LFR.

  • Page 11: General Information

    1.7.1. Scope of Delivery The delivery includes the following items: 1. iPeak® reader 4,3” main unit (Cat.100033000). 2. Drawer (Customized for each IUL’s Partner Cat. 9000xxxxx). 3. Adjustment drawer (Cat.900013732) 4. External power supply unit (Cat. 900020088 or 900020089). 5. Power cord (Cat. 900020077, Cat. 900020079, Cat. 900020080, Cat.

  • 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® reader 4,3”, it is essential that you read this 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® reader 4,3” 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® reader 4,3” becomes electrically unsafe, prevent other personnel from operating it, and contact IUL SA Technical Service.

  • Page 16: Environment

    • The instrument has been stored under unfavourable 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 WARNING 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 on the “Ordering Codes”...

  • Page 17: Biological Safety

    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® reader 4,3” 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

    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 Type plate on the bottom of the Catalog Number. instrument and the external box label Type plate on the bottom of the Serial Number. instrument and the external box label Label on the side of Indicates a carrier that contains unique the external box device identifier information.

  • Page 21: Cybersecurity

    All the cybersecurity controls are integrated into the SW storage, including SW integrity verification, firewall, and 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 the LFR’s setup and operation process.

  • Page 22: General Description

    3. GENERAL DESCRIPTION Device Overview FRONT VIEW: 1. Power button. 2. Power ON indicator (white LEDs). 3. Touchscreen and display. 4. Drawer insertion slot. 5. Barcode reader. Doc. 50008314-10 Page 20 of 68...
  • Page 23 REARVIEW: 6. Battery in charge red LED. 7. External power supply socket. 8. Ethernet socket. 9. USB host port (only accessible for slim USB memory sticks). 10. Software Wipe buttonhole. 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 on the “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 Unpack the Device The packaging of the iPeak® reader 4,3” 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: Operating Procedures

    5. OPERATING PROCEDURES CAUTION Before switching on the reader for the first time or after a 6 months period of inactivity, it is essential to plug it into the mains supply. Failure to do so may cause permanent damage to the unit. Login Screen To start the LFR, press the power button (see section 3.1) and wait until the Login Screen is shown:...

  • Page 27: Home Screen Overview

    NOTE: If you forget or lose your password, contact your LFR’s Manager. To end the user’s session, select ‘Logout’ on Tools Menu (see section 5.6.4 for more information) or power off the LFR. Home Screen Overview The Home screen displays the current Cassette Settings, date, time, battery status, ‘NEW SCAN’...

  • Page 28: Cassette Processing

    Remote export icon. Depends on configuration. Only visible when a valid token is checked. 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).
  • Page 29 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 approximately 5 cm of distance. Press the ‘ACTIVATE BARCODE READ’ button (see green circle). The barcode reader starts its reading process using a light.
  • Page 30 Press the ‘SELECT AS CURRENT’ button to load the Cassette Settings of the row. B.2 ‘Barcode Autodetection’ launches directly the scan if the option ‘Barcode Autodetection’ is selected by the IUL’s partner. CAUTION The LFR will automatically load the proper Cassette Settings if it is...
  • Page 31 Press the ‘ACTIVATE BARCODE READ’ button (see yellow 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. If the Small-Data Matrix does not correspond to the Cassette Settings currently loaded in the LFR, an error message is displayed.
  • Page 32 After typing an identification text on the virtual keyboard, press the ‘Enter’ button (see the yellow 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 33 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 34 The scan buttons (‘SCAN’ and ‘TIMED SCAN’) remain in grey until a valid Cassette Settings is loaded, an ID is set (if required), and a drawer is placed inside the LFR. Depending on the LFR’s configuration a cassette’s confirmation barcode could be also required. When all conditions are reached the scan buttons turn coloured, as in the following image: 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’...

  • Page 35: System Menu

    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 fiber or dust.
  • Page 36 • Format USB: Press this button to format properly a slim USB memory stick, and then be able to use it to export CSV and PDF results, write logs, and update the LFR software. • Export Logs to USB: Press this button to write internal data to a slim USB memory stick plugged into the USB host port.

  • Page 37: Cassette (Administrator Only)

    5.4.2. Cassette (Administrator only) Only 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 have a parameter called Cassette Settings Version.

  • Page 38: 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 39 • 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 40 When set to OFF and the logged user is an Operator, this parameter will be hidden when the result is displayed or exported (ticket, PDF report, and CSV file). NOTE: Contact IUL SA to request technical specifications of Remote Export or SFTP Export functionalities: Phone: +34932740232; Email: iul@iul-inst.com Doc.

  • Page 41: Printer (Administrator Or Manager Only)

    5.4.4. Printer (Administrator or Manager only) Only users with the role of Administrator or Manager can access this screen. A desktop printer model could be selected, and communication parameters for a ticket printer are displayed and could be edited. • Desktop printer: To select a desktop printer model.

  • Page 42: Network (Administrator Or Manager Only)

    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. Users with the Operator’s role can only set the Airplane Mode. Network communications parameters are displayed: lfr_XXXX • Airplane Mode: If ON, Wi-Fi connections are disabled, and an airplane icon is shown on the Top Bar.
  • Page 43 • WLAN: Displays the current Wi-Fi network’s configuration. Press its SET button to configure it. With option ‘Access Point’ (default), its SSID and password should be set but also a subnet selected from available ones. With option ‘DHCP Client’ it is possible to connect the LFR to a Wi-Fi net if the proper SSID and password are set.

  • Page 44: Versions

    5.4.6. Versions Displays a list of information related to the LFR and its software. Lfr-ipeak-4.3-3.0-s • 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 45: Side Menu

    Side Menu By pressing the menu symbol on the left of the Top Bar, a drop-side menu is displayed with the following options: 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’...
  • Page 46 After selecting one row the following screen is reached: Press ‘DELETE’ (see red circle) to delete this Cassette Settings from the available list. Drag up on the screen and select each tab to visualize all data related to this Cassette Settings: •...

  • 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 NOTE: After pressing the ‘RETRY SFTP’ button refresh the screen to ensure that the SFTP state has properly been updated NOTE: The results sent successfully can’t be sent again through SFTP. A- RESULT VIEW Select a scan result to explore its information and print it as a ticket, as a report, or export a report and (for users with the role of Administrator or Manager) delete the scan result.
  • Page 49 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. See section 0 to connect and configure a ticket printer (Administrator and Manager roles only).
  • Page 50 B- EXPORT RESULTS BUTTON After pressing the ‘Export Results’ button 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 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. • reference: Sample/patient id (maximum length 2024 characters). • uuid: Unique identifier of the scan (also included in the captured image name).

  • Page 52: Tools Menu

    Tools Menu Pressing the gear symbol on the centre-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 Only)

    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: • If the LFR displays the green message: ‘Password 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 in 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

    CAUTION Do not update an LFR with software version 3.x using an update package 2.x or 1.x. To update the Software, follow these steps (under IUL’s partner supervision if you do not have an Administrator role): • Format a slim USB memory stick in the ‘SYSTEM’ tab from the System Menu of the LFR (see section 5.4.1).

  • Page 56: Browser Generic Operations

    • Remove the slim USB memory stick. The LFR is ready. CAUTION The software update procedure takes some time (around 40 minutes), during which the device may seem unresponsive. Do not power off the device until the procedure is completed. Browser Generic Operations Here are some tips to browse the iPeak®...

  • Page 57: 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 58 Symptom Probable cause Recommended action Damage to USB socket or its Contact the Technical Service internal connection port for repair Some obstacle prevents the drawer or the cassette from Remove the obstacle being completely inserted It is not possible to perform a scan and the following message Place the cassette in the drawer No drawer has been inserted in...
  • Page 59 the System Menu (see section 5.4.1), and send the files by e-mail to the Technical Service. Doc. 50008314-10 Page 57 of 68...

  • Page 60: Maintenance

    4,3” label. It is the responsibility of the final user and not IUL SA to use the device beyond this date. If the iPeak® reader 4,3” 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 61: Appendix A: Ordering Codes

    APPENDIX A: ORDERING CODES Spare Parts Product Contents Cat. # Customized Drawer 1 unit 9000xxxxx iPeak® self-adjusting light drawer 1 unit 900013732 External power supply 1 unit 900020088 External power supply (US) 1 unit 900020089 Power cord Schuko 1 unit 900020077 Power cord (US / JP) 1 unit...

  • Page 62: Appendix B: Technical Data

    (it is supplied with an external power supply unit that can be used in 50Hz-60Hz) Maximum power 40 W Overvoltage category Air temperature 15 ~ 30 ºC In lines with an intensity around the center of the dynamic range of IUL’s Quality Control pattern. Doc. 50008314-10 Page 60 of 68...
  • Page 63 Relative humidity 10 ~ 75 % (non-condensing) Altitude Up to 2000 meters (6500ft.) Place of operation For indoor use only Pollution level Transportation conditions Air temperature 5ºC ~ 40ºC (41ºF ~ 104ºF) In manufacturer’s packaging Relative humidity Maximum 75 % (non-condensing) Storage conditions Air temperature 5ºC ~ 40ºC (41ºF ~ 104ºF)

  • Page 64: 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 65: 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 66: Appendix E: Eu Declaration Of Conformity

    2017 on in vitro diagnostic medical devices. Barcelona, November the 28 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 50008290. Doc. 50008314-10 Page 64 of 68...

  • Page 67: 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 68: 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. 50008314-10 Page 66 of 68...

  • Page 69: 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 70: Appendix I: Applied Standards

    APPENDIX I: APPLIED STANDARDS The iPeak® reader 4,3” 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 71 Notes Doc. 50008314-10 Page 69 of 68...
  • Page 72 © 2023 IUL SA All rights reserved...

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