IUL iPeak Plus Instructions For Use Manual
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IUL iPeak Plus Instructions For Use Manual

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

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  • Page 1 iPeak® Plus Instructions for Use Software Version 3.x 50008329-05 Revision Date: January 2023...

  • Page 3: Table Of Contents

    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 ..................
  • Page 4 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 ..................
  • Page 5 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 ....................
  • Page 6 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 ......

  • Page 7: Indication Of The Introduced Modifications

    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.

  • Page 8: Glossary

    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...

  • 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: 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.

  • Page 11: General Information

    1.7.1. Scope of delivery The delivery includes the following items: 1. iPeak® Plus main unit (Cat. 100034000). 2. Drawer (Customized for each IUL’s Partner Cat. 9000xxxxx). 3. Adjustment drawer (Cat. 900012010) 4. External power supply unit (Cat. 900020089). 5. Power cord (Cat. 900020090 or 900020080).

  • 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® 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. The following types of safety information appear throughout the iPeak®...

  • Page 14: Electrical Safety

    If the operation of the iPeak® Plus 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® Plus 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 In case of replacement or loss of the external power supply or the...

  • 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® Plus 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...

  • 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: Symbols On The Ipeak® Plus Device

    Symbols on the iPeak® Plus Device Symbol Location Description Type plate on the CE Mark, Declaration of Conformity, see bottom of the “EU Declaration of Conformity”. instrument and the external box label Type plate on the Medical device manufacturer. bottom of the instrument and the external box label Type plate on the...
  • Page 21 Symbol Location Description Consult instructions for use. Type plate on the bottom of the instrument and the external box label Type plate on the Caution is necessary when operating the bottom of the device. instrument Label on the side of All components of the instrument are the external box recyclable.

  • Page 22: 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 23: General Description

    3. GENERAL DESCRIPTION Device Overview FRONT VIEW: 1. Power button 2. Device ON white LEDs 3. Touchscreen and display 4. Drawer insertion slot 5. Barcode reader Page 21 of 67 Doc. No 50008329-05...
  • Page 24 REAR VIEW: 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 ATTENTION: For proper insertion of a slim USB memory stick, its body section near the connector must be 8,5x16mm or less.

  • Page 25: 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 iPeak® Plus is equipped with a power cord with a plug suitable for the destination country.

  • Page 26: Installation

    4. INSTALLATION Unpack the Device The packaging of the iPeak® Plus 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 27: 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 iPeak®...

  • Page 28: Home Screen Overview

    To end a user’s session, select ‘Logout’ on Tools Menu (see section 5.6.4 for more information) or power off the iPeak® Plus. Home Screen Overview The Home screen displays the current Cassette Settings, date, time, battery status, ‘NEW SCAN’ button, and ‘SYSTEM MENU’ button. Main Screen: Press this button to start a new Cassette Processing.

  • Page 29: 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 30 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). 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 31 B.2 ‘Barcode Autodetection’ launches directly the scan if the option ‘Barcode Autodetection’ is selected by the IUL’s partner. ATTENTION: The LFR will automatically load the proper Cassette Settings if it is stored (Cassette Settings list), the current cassette has a Confirmation Barcode embedded in it, and some valid (not expired) Cassette Settings are shown on the Top Bar.
  • Page 32 If the Small-Data Matrix does not correspond to the Cassette Settings currently loaded in the iPeak® Plus, an error message is displayed. In such a case, use a cassette of the proper type, or load another Cassette Settings corresponding to the current cassette.
  • Page 33 NOTE: Depending on the LFR’s configuration, if the reference you enter is already in the LFR’s stored results, a message is displayed and scan buttons could be disabled. Sample/patient ID using the virtual keyboard: Special characters are not available and its maximum length is 30. Sample/patient ID using the barcode reader: Special characters are allowed and the maximum length is 1024.
  • 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), a drawer is placed and a cassette is properly placed inside the iPeak® Plus. Depending on the LFR’s configuration a cassette’s confirmation barcode could be also required.
  • Page 35 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 36: System Menu

    System Menu Set the configuration through this menu. Different tabs are available, depending on the user’s role. 5.4.1. System NOTE: Depending on the configuration some items are not displayed. • Language: Select one language among those installed in the LFR. •...

  • Page 37: Cassette (Administrator Only)

    • Set Date/Time: Define the current date and time. This parameter has configurable access. NOTE: The LFR is not ready to work with dates before the manufacturing date. • Set Time Zone: Define the current time zone. ATTENTION: After changing Time Zone, re-start the LFR. •...
  • Page 38 • 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. When the value of the LFR is set to “0”, the LFR accepts all Cassette Settings.

  • Page 39: Preferences (Administrator Only)

    5.4.3. Preferences (Administrator only) Only user “admin” (role Administrator) can access this screen. Some parameters are displayed and could be edited: • Sample ID Checking: Four ID checking levels are available: ‘No Check’, ‘Required’, ‘Warn if Duplicate’, and ‘Block if Duplicate’. →...
  • Page 40 (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: +34932740232 ; Email: iul@iul-inst.com Page 38 of 67 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 turn on 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: Versions

    • 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: Side Menu

    • Current SW Version: Software version of the LFR. • Hardware Version: Hardware version of the LFR. • Product Image Version: Name of image file burn-in current SD. • Wipe clean SW Version: Software version if a wipe clean is performed. •...
  • Page 45 NOTE: The maximum number of Cassette Settings that LFR stores could be set between 1 and 10 (see section 5.4.2 for more explanations). 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 46: 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 47 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 48 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 5.4.4 to connect and configure a ticket printer (Administrator role only). 2020-11-16 16:51:23 (CET) ID: test...
  • Page 49 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 on 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 50 • reference: Sample/patient id (maximum length 2024 characters). • uuid: Unique identifier of the scan (also included in the captured image name). • timeStamp: UTC time of the scan. • comments: Comments added after the scan. • cassette type: Name of Cassette Settings. •...

  • Page 51: 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. 5.6.2. User Management – Change Password This screen allows password changing. As Administrator or Manager, a ‘Username’...

  • Page 52: 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 53 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 54: 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 55: Browser Generic Operations

    • Remove the slim USB memory stick. The LFR is ready. CAUTION The software update procedure takes some time (around 20 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 56: Troubleshooting

    6. TROUBLESHOOTING Symptom Probable cause Recommended action Plug the Power supply unit to The LFR cannot turn ON Battery discharged recharge The LFR cannot turn ON or Contact the Technical Service Damage to the ON/OFF button turn OFF for repair Too much time of inactivity Increase the inactivity time in the switches...
  • Page 57 Symptom Probable cause Recommended action Some obstacle prevents the drawer or the cassette from Remove the obstacle being completely inserted It is not possible to perform a There is no cassette inserted Place the cassette propely scan and the following message is displayed “Please fit drawer and cassette properly”...

  • Page 58: Maintenance

    The iPeak® Plus can run for 5 years from the manufacturing date indicated in the iPeak® Plus label. It is the responsibility of the final user and not IUL SA to use the device beyond this date. If the iPeak® Plus 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 59: Appendix A: Ordering Codes

    Power cord (USA) 1 unit 900020080 Power cord Schuko 1 unit 900020090 Optional Accessories Product Contents Cat. # Ticket printer (serial interface, 40 1 unit 90004875 columns) iPeak Plus UQC 1 unit 900012100 Page 57 of 67 Doc. No 50008329-05...

  • Page 60: Appendix B: Technical Data

    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. Page 58 of 67 Doc. No 50008329-05...

  • Page 61: Transportation Conditions

    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 62: 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 63: Appendix D: Waste Electrical And Electronic Equipment (Weee)

    APPENDIX D: WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) This section 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 64: Appendix E: Eu Declaration Of Conformity

    April 2017 on in vitro diagnostic medical devices. Barcelona, July the 11 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 50008381. Page 62 of 67 Doc. No 50008329-05...

  • Page 65: 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 66: 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. Page 64 of 67 Doc. No 50008329-05...

  • Page 67: 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 68: Appendix I: Applied Standards

    APPENDIX I: APPLIED STANDARDS The iPeak® Plus 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 69 Notes Page 67 of 67 Doc. No 50008329-05...
  • Page 72 © 2023 IUL SA All rights reserved...

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