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Abbott i-STAT Alinity Operation Manual

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  • Page 2 Patents: ©20 1 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of  companies or their respective owners.  i-STAT Alinity – System Operations Manual Art: 746981-01 Rev. I Rev. Date: 19‐Oct‐2021...

  • Page 3: Table Of Contents

    Table of Contents Foreword i-STAT ALINITY INSTRUMENT - END USER LICENSE AGREEMENT.............viii Regulatory compliance xiii Symbols Definitions and Terminology xxxiii 1 - i-STAT Alinity Reference................. 1 1.1 - Complete i‑STAT Alinity System Overview 1.2 - i-STAT Alinity Instrument Principles of Operation......................8 More Options........................
  • Page 4 1.13 - Software Updates Software Update and Installation using USB memory device via Base Station..... 97 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wired Network Connection..................101 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wireless Network Connection...................
  • Page 5 *Patient Settings Category....................173 ID Entry........................174 Patient Information and Positive Patient Identification (PPID).........177 Summary........................178 *Analyte Settings Category....................179 Units......................... 180 Sample Types......................181 Ranges........................182 Enable/Disable Analyte.................... 185 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745538-01 Rev. R...
  • Page 6 Connectivity Map..................... 245 Summary........................246 Assemble a Profile ......................247 Install a Profile from a USB....................249 3.5 - AlinIQ CWi – Customization Workspace for i-STAT Troubleshooting 251 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745538-01 Rev. R...

  • Page 7: Foreword

    Foreword The Abbott i‑STAT Alinity system is designed to function consistently and dependably from day to day. It is supported by dedicated professionals who excel in engineering, medical technology, training, and service. Abbott Point of Care is dedicated to manufacturing high-quality and reliable instrumentation. We look forward to serving your needs.

  • Page 8: I-Stat Alinity Instrument - End User License Agreement

    (collectively, the “Device”). This EULA is a legal agreement between you (“you”, “End User”), and Abbott Point of Care Inc. (“APOC”, “we”, “our” or “us”) that describes the terms and conditions applicable to your use of the software installed on or used in connection with the Device, including any software already pre-installed on the Device, software that you may download from https://www.globalpointofcare.abbott/en/support/istat-brand/istat-alinity.html,...
  • Page 9 APPLICABLE. HOWEVER, SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
  • Page 10 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
  • Page 11 APOC may have under trade secret, copyright, patent or other laws. The provisions of Sections 2, 5, 6, 7, 8 and 11 shall survive the termination of this EULA. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
  • Page 12 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...

  • Page 13: Regulatory Compliance

    – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment Radio/Telecommunication Regulations: Antigua & Barbuda ABTD Antigua & Barbuda Telecommunications Division Type Approval Certificate Number 25-TAC2513000853 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 14 Type approval and homologation of equipment pursuant to Section 50 of The Electron Communication Act 2011 Type Approval CTYPE-01305 and CTYPE-01306 Bolivia Autoridad de Regulación y Fiscalización de Telecomunicaciones y Transportes Type Approval ATT-DJ-RA-H-TL-LP 46/2018 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 15 Certificate. No: KY1504003 China Radio Transmission Equipment Type Approval CMIIT ID: 2019AJ8315 Colombia Communications Regulatory Commission (CRC) - Exempt Costa Rica Superintendencia de Telecomunicaciones approval 04979-SUTEL- DGC-2017 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 16 CERTIFICATE OF TYPE APPROVAL per HKCA 1039 Issue 6, June 2015 India Ministry of Communcations & IT Equipment Type Approval, ETA Certification No: ETA – 3319/16- RLO(WR) i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 17 Autorite de Regulation des Technologies de Communication (ARTEC) No 17/026/ARTEC/DG/DHCT/SSS/test Maldives Communications Authority of Maldives Type Approval CAM- TAC2019-03 Mauritius Information & Communication Technologies Authority (ICTA) Type Approval Certificate Reference Number: TA/2017/0214 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 18 Homologacion, Code: TRSS39479, Report: 2158-2017-MTC/29.CGH.CH Applied Technical Standard: PNAF-R.M. No. 187-2005-MTC/03, pub. 04/03/2005 – R.M. No. 777-2005-MTC/03, pub. 11/05/2005 Philippines National Telecommunications Commission Type Acceptance Certificate No. ESD-1714467C i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 19 Telecommunications (Terminal Equipment and Public Networks) Regulations, No. 10 or 2002 Certification of Type Approval, Certificate No.:LCT/AP17.118D St. Maarten Bureau of Telecommunication and Post Type Approval Certificate no 2017/018-b/TA i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 20 FCC 47 CFR Part 15, Subpart E - Unlicensed National Information Infrastructure Devices FCC ID: 2AAEX-SDABGN Vietnam Ministry of Information and Communications Type Approval Certificate No: C0031280217AE01A2 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 21 European Union (EU) WEEE Directive 2012/19/EU European Union (EU) REACH Regulation 1907/2006/EC European Union (EU) Packaging and Packaging Waste Directive 94/62/EC Federal Communications Commission (FCC) Statement (United States only) i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 22 For product available in the USA/Canada market, only channels 1-11 can be operated. Selection of other channels is not possible. If this device is to be operated in the 5.15~5.25GHz frequency range, it is restricted to indoor environments only. i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 23 Antenna: Laird Technologies, Mini-NanoBlade Antenna gain information: Embedded Antenna: 2.5dBi (2.4 GHz), 4.8dBi (5 GHz) Frequency Tolerance：+/-20ppm ** See website for Declaration of Conformity for associated EMC/RED/LVD standards. i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
  • Page 24 Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...

  • Page 25: Symbols

    On/Off Direct current (DC) Alternating current (AC) For prescription use only. For use with the i-STAT Alinity Instrument only. Battery status - fully charged Battery status - approximately ½ charged Battery status - charge needed soon Battery status - charge immediately...
  • Page 26 Symbol Definition/Use Software update is available. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 27 Table 3: Wireless Network Status Symbol Definition/Use Best Very good Good Fair Poor No Connection Wireless disabled Wireless connecting Table 4: Wired Network Status Symbol Definition/Use Connected Disabled i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 28 Signifies that the product bearingt he ETL Listed mark complies with both U.S. and Canadian product safety standards: UL 61010-1: 3rd Ed; Am.1 CAN/CSA C22.2 No. 61010-1-12 3rd Ed. (R2017) +U1;U2 Electrical hazard Attention: See instructions for use. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 29 Rules and Regulations, Title 47, Part 15 Subpart B, for Class A devices. The near-patient testing symbol illustrates that a device can only be used in a near-patient setting by a health worker, professional or trainee. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 30 Table 6: Control related Symbol Definition/Use Control Table 7: For use on i‑STAT Value Assignment Sheets Symbol Definition/Use Mean Range i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 31 Base excess (b for blood, ecf for extracellular fluid) AnGap Anion Gap Oxygen saturation eGFR Estimated Glomerular Filtration Rate eGFR-a Black/African-American Estimated Glomerular Filtration Rate GFAP Glial Fibrillary Acidic Protein UCH-L1 Ubiquitin Carboxy-terminal Hydrolase L1 i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
  • Page 32 Quality Check Failure Quick Reference Guide R-VAS Rilibak Value Assignment Sheet ReVAS Rilibak Electronic Value Assignment Sheet Software Update Traumatic Brain Injury Universal Serial Bus Value Assignment Sheet i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...

  • Page 33: Definitions And Terminology

    Assigned Category applied to a profile or a profile applied to an instrument Base Station Component of the i-STAT Alinity system whose primary function is to recharge the battery attached to an instrument. Optional functionality includes providing wired communication, wired connection to the i‑STAT Alinity printer and USB connection to the...
  • Page 34 Group of features used to define the behavior of an instrument. Selections made in this setting group are names, IP addresses and ports of other systems with which the i-STAT Alinity is to communicate information. Cardiopulmonary Bypass Surgery Setting. The CPB function adjusts hematocrit and hemoglobin results for the dilutional effect of pump fluid during cardiopulmonary bypass surgery.
  • Page 35 Observations Connectivity mapping for test records. Area for entering IP address and network port for the POC data manager. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
  • Page 36 IQCP guidelines. This is one of five categories that is required to build a profile. Ranges Healthcare organization-defined ranges for reference, action and reportable. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
  • Page 37 Message created to display on the instrument before any selections are made. User Role There are 3 user roles in the CWi. The roles define what CWi privileges each user has. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
  • Page 38 Organization Manager Primary is the only role that can assign additional healthcare organization managers. This is also the contact person if Abbott Point of Care should need to contact the healthcare organization. It is imperative that this role be updated if this individual needs to be changed.
  • Page 40 This page intentionally left blank. i-STAT Alinity — System Operations Manual Art: 746989-01 Rev. A Rev. Date: 02-Oct-2016...

  • Page 41: I-Stat Alinity Reference

    • i‑STAT Alinity Quick Reference Guide • i‑STAT Alinity Getting Started Guides: ￮ i‑STAT Alinity Base Station ￮ i‑STAT Alinity Rechargeable Battery ￮ i‑STAT Alinity Electronic Simulator ￮ i‑STAT Alinity Printer i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...
  • Page 42 Base Station Provides recharging, printing, and network connectivity capabilities to the instrument. i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...
  • Page 43 Alinity. Electronic Simulator Provides an independent check on the instrument's ability to take accurate and sensitive measurements of voltage, current and resistance from the cartridge. i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...
  • Page 44 Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...

  • Page 45: I-Stat Alinity Instrument

    Note: Not all cartridges are available in all regions. Check with your local representative for availability in specific markets. Note: To configure the instrument's printing method, refer to the i-STAT Alinity Printer Principles of Operation Verify the instrument for cartridge testing Note: Verification is only required once per cartridge type per instrument.

  • Page 46: Principles Of Operation

    • low power audio processor with built-in speakers • display and navigation of instrument screens • networking applications • CMOS-based area array with LED aiming and illumination barcode module: i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 47 IEEE802.11 a/b/g/n wireless module. Connectivity to the i‑STAT Alinity portable printer is available via infrared communication or through wired connection to the printer employing the Base Station. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 48 Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

  • Page 49: More Options

    More Options This section describes the selections and information found behind the More Options button. From the Home Screen touch More Options and this screen displays: i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 50 More Options. If permission levels are set via Data Management, at least one operator must have permission level of Key Operator or Supervisor. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 51 NCi utility. When the instrument is configured, this button will become active and enable is the default. Disable Prevents instrument from communicating via wireless transmission. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 52 This method of QC testing must be set up via a customization profile as well as activation in the data management system. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 53 • remove the USB and reinsert • ensure that the USB is formatted Install from Server View Disabled Cartridges Cartridges are disabled due to expired QC. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 54 Reserved for future use. Delete Profile Follow prompts on screen to delete the customization profile installed on instrument. Profile Status List of information regarding customization profile loaded on instrument. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 55 Displays lists to be deleted. Choose list(s) and follow prompts on the screen to complete. List Status Displays information pertaining to patient, operator and cartridge lot list. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 56 See Software Updates section of this manual for complete details for downloading and installing software via the Abbott Managed Server. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 57 See the section Instrument Clock Date/Time Synchronization for details. Set Units Set Date Format i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 58 If the instrument does not detect the USB drive, try the following: • remove the USB and reinsert • make sure the USB is formatted. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 59 Disabling stops the instrument from communicating with the wireless Delete Network Settings Follow prompts to complete this action. Network Status List of information associated with wireless and wired communication. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 60 Perform Conditioning Cartridge Touch this button to perform conditioning procedure using a conditioning cartridge. Contact Technical Support or local representative to obtain the conditioning cartridge and instructions for use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 61 Touch the character until the additional options display at the bottom of the keypad: After several seconds, the additional characters will disappear allowing the operator to continue typing without requiring any additional keystrokes. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 62 The Synchronize Clock with Data Manager check box is only available on the Set Clock screen when the instrument is configured to communicate with a data manager. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

  • Page 63: Calibration Of The I-Stat Alinity Instrument

    *** rather than results. Abbott Point of Care developed the internal simulator that functions as a signal-checking mechanism on every cartridge inserted. The internal simulator is a combination of hardware and software that tests the ability of the instrument to accurately read sensor signals.

  • Page 64: Specifications

    No natural or synthetic rubber latex is used anywhere on the exterior of this product, the product packaging, or the accessories. Wireless Labeling The i-STAT Alinity instrument includes the FCC mark and FCC module identifier. Table 1–1: Wireless specifications for the i-STAT Alinity instruments Wireless Characteristic i-STAT Alinity Instrument Network Standard IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11n (1-stream)

  • Page 65: Precautions And Limitations

    • always place the instrument and peripherals on a stable surface or in a location where they will not cause injury if dropped. • use only the accessories and consumables specified or supplied for this system by Abbott Point of Care.
  • Page 66 • make any unauthorized repairs or modifications to this product as this may cause personal injury or damage to the unit. NOTE: • Protection provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care. • Operators should use standard precautions whenever handling the instrument, cartridge, and peripherals to protect themselves from blood-borne pathogens.

  • Page 67: Messages And Troubleshooting

    Quality Check Failure Codes (QCFs) indicate an issue was detected with the instrument, cartridge, sample or software. The failure of any quality check causes the instrument to display a quality i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N...
  • Page 68 2-01-1.1.1 2-01 2-02-1.1.2 2-02 8-01-2.1.8 P / BB 8-01 11-01-2.13.32 11-01 13-01-1.6.1 13-01 17-01-8.2.1 17-01 18-01-8.2.2 18-01 19-01-8.2.3 19-01 20-01 20-01-3.1.1 21-01-3.1.3 21-01 22-01-6.1.3 22-01 22-01-6.1.5 22-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 69 28-01 29-01-4.1.3 29-01 30-01-6.1.4 30-01 30-01-6.1.7 30-01 30-02-4.1.4 30-02 31-01-4.1.5 31-01 31-02-6.1.16 31-02 32-01-4.1.6 32-01 33-01-4.1.8 33-01 34-01-4.1.11 34-01 35-01-4.1.7 35-01 36-01-4.1.10 36-01 37-01-4.1.9 37-01 38-01-4.1.12 38-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 70 53-01-2.9.3 53-01 57-01-2.4.1 57-01 59-01-4.5.1 59-01 60-01-1.6.2 C / AA 60-01 63-01-2.9.1 63-01 63-01-2.9.2 63-01 66-01-2.2.1 66-01 66-01-2.2.2 66-01 66-01-2.2.3 66-01 68-01-2.4.2 68-01 69-01-3.6.1 69-01 69-02-3.6.2 69-02 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 71 90-01 90-01-2.4.5 90-01 90-01-2.4.6 90-01 90-01-2.4.7 90-01 90-01-2.4.8 90-01 90-01-2.4.9 90-01 90-01-2.4.10 90-01 90-01-2.4.11 90-01 90-01-2.4.12 90-01 90-01-2.4.13 90-01 90-02-2.4.14 90-02 90-02-2.4.16 90-02 90-02-2.4.17 90-02 90-02-2.4.18 90-02 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 72 123-01 124-01-5.1.25 124-01 125-01-5.1.26 125-01 126-01-5.1.27 126-01 127-01-5.1.1 127-01 127-01-5.1.3 127-01 128-01-5.1.5 128-01 129-01-5.1.7 129-01 130-01-5.1.8 130-01 131-01-5.1.10 131-01 132-01-5.1.15 132-01 133-01-5.1.20 133-01 134-01-5.1.16 134-01 134-01-5.1.17 134-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 73 149-01 150-01-5.2.4 150-01 150-01-5.2.9 150-01 151-01-5.2.5 151-01 151-01-5.2.10 151-01 152-01-5.2.11 152-01 165-01-8.1.1 165-01 166-01-8.1.2 166-01 167-01-8.1.3 167-01 170-01-8.1.4 170-01 171-01-8.1.5 171-01 172-01-8.1.6 172-01 173-01-8.1.7 173-01 174-01-8.1.8 174-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 74 System Administrator Note: If code displays after operator repeats testing, instruct the operator to perform conditioning using a Conditioning Cartridge. Contact Technical Support or local representative for Conditioning Cartridge and instructions for use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 75 Cartridge was rejected during the testing cycle. Probable causes: • Excess sample was added to the cartridge • Operator pressed too hard on the center of the cartridge i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 76 Simulator insertion. Ensure the Simulator is fully inserted. The Simulator is fully inserted when the click is heard. If the same quality check failure displays, contact the system administrator for further instruction. Reserved for future use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
  • Page 77 Conditioning Cartridge. Ensure the Conditioning Cartridge is fully inserted. The Conditioning Cartridge is fully inserted when the click is heard. If the same quality check failure displays, contact the system administrator for further instruction. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

  • Page 78: Cleaning And Disinfecting

    Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide. The graphics below are a visual representation of the wiping procedure for disinfection. Note: When cleaning and disinfecting the instrument, the rechargeable battery must be attached. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

  • Page 79: I-Stat Alinity Results Screen

    1.3 - i-STAT Alinity Results Screen The content of a result screen is specific to the cartridge type and material being tested. The following screen is an example of a patient result screen with a cartridge that contains one test: Description of the displayed screen;...
  • Page 80 ￮ Customized Action Range • Instrument Status • Quality Options • Administrative Options • Instrument Options Displays information associated with the test Prints result to i‑STAT Alinity printer i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...

  • Page 81: Interpreting Results

    "star out", as shown in the example below: Reasons such as those listed below may produce starred out results: • an uncharacteristic sensor signal • a bad sensor • improperly stored cartridge i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...
  • Page 82 The following section provide examples for various analytes, when the analyzer is customized with Align IQ CWI. Not all cartridges are available in all regions. Ability to run a cartridge is controlled by the instrument and by region. i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...
  • Page 83 (critical) range. ￮ White arrow in page button - indicates all results on second page are within the reference range. i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...
  • Page 84 Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...

  • Page 85: I-Stat Alinity Rechargeable Battery

    1.4 - i-STAT Alinity Rechargeable Battery Overview This Lithium-Ion rechargeable battery is designed for use only with the i‑STAT Alinity instrument. When attached to the instrument, it is the power source for all functionality. Thumb tabs on either side of the battery enable easy removal and replacement of the battery on the instrument.

  • Page 86: Specifications

    100% charged and ready for use after 4 hours. • use only a rechargeable battery pack purchased from Abbott Point of Care. • use only the accessories and consumables specified or supplied for this system by Abbott Point of Care.
  • Page 87 Base Station. • Protection provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care. • The instrument and its peripherals are not listed by any authority with respect to suitability for use in oxygen-enriched atmospheres.
  • Page 88 Alinity — System Operations Manual Art: 745529-01 Rev. G Rev. Date: 04-Mar-2021...
  • Page 89 1.5 - i-STAT Alinity Base Station Overview The primary function of the Base Station is to charge the rechargeable battery while it is attached to the i‑STAT Alinity instrument. The Base Station is intended for use only with the i‑STAT Alinity instrument.

  • Page 90: I-Stat Alinity Base Station Specifications

    -10 to 60ºC (14 to 140ºF) 10 to 90% non-condensing, with maximum saturation temperature of 50ºC (122ºF) External Power Supply Unit Input: 110-240 VAC, 50-60 Hz, 1.5A Output: 5.3V DC, 6.6A i-STAT Alinity — System Operations Manual Art: 745528-01 Rev. G Rev. Date: 16-May-2022...

  • Page 91: Precautions And Limitations

    Ensure that the Base Station is connected properly and that the instrument is seated correctly in the Base Station. • Protection provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care.

  • Page 92: Troubleshooting

    Cleaning and Disinfecting Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide. The graphics below are a visual representation of the wiping procedure for disinfection. i-STAT Alinity — System Operations Manual Art: 745528-01 Rev. G Rev. Date: 16-May-2022...

  • Page 93: I-Stat Alinity Electronic Simulator

    The Electronic Simulator is designed for use only with the i‑STAT Alinity instrument. Abbott Point of Care requires that a successful Electronic Simulator test is performed every 6 months. For instructions on using the Electronic Simulator, refer to the i‑STAT Alinity Electronic Simulator Getting Started Guide.

  • Page 94: Precautions And Limitations

    • touch the area under the cap. NOTE: • Function provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care. • The instrument can become contaminated with blood during use. Operators should use standard precautions whenever handling the instrument, cartridge, and peripherals to protect themselves from blood-borne pathogens and pathogens from other body substances.

  • Page 95: Cleaning And Disinfecting

    Cleaning and Disinfecting Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide. The graphics below are a visual representation of the wiping procedure for disinfection. i-STAT Alinity — System Operations Manual Art: 745530-01 Rev. D Rev. Date: 16-May-2022...
  • Page 96 Alinity — System Operations Manual Art: 745530-01 Rev. D Rev. Date: 16-May-2022...

  • Page 97: Perform Electronic Simulator Testing

    Storing the Electronic Simulator Store the Electronic Simulator with the cap on in the box in which it was shipped. i-STAT Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...
  • Page 98 Perform a test using the Electronic Simulator i-STAT Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...

  • Page 99: Perform The Thermal Probe Check

    • Acceptable: PASS • Not acceptable: FAIL message with a Quality Check Failure Code. Repeat the procedure to confirm results. If the repeat test fails contact Technical Support. i-STAT Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...
  • Page 100 Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...

  • Page 101: I-Stat Alinity Printer

    The printer is recharged using a power adapter connected to an outlet. For additional information on printer assembly and use, see the i‑STAT Alinity printer Getting Started Guide. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

  • Page 102: Principles Of Operation

    5. Touch Print Selected. An audible beep is heard when the instrument has successfully transmitted all results to the printer. Printer may still be printing when beep is heard. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

  • Page 103: Specifications

    -20 to 50ºC (-4 to 122ºF) 10 to 90% Non-condensing Communication link Infrared or Serial/RJ11 Paper black print thermal paper 5.7 cm wide Available from Abbott Point of Care i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

  • Page 104: Precautions And Limitations

    For best results, observe the following precautions when using the i‑STAT Alinity printer. • use only a rechargeable battery pack purchased from Abbott Point of Care. • use only the power adapter and supply provided with the i‑STAT Alinity printer kit.

  • Page 105: Troubleshooting

    The printer's POWER indicator does not Recharge the battery. illuminate when the printer is powered The printer does not print, and the Add paper to the printer. STATUS indicator is orange. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...
  • Page 106 4. Reconnect the power cord. Then, press the power button to turn the printer on. Attempt to print a record from the instrument. If a printer failure occurs, contact Technical Support. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

  • Page 107: Cleaning And Disinfecting

    Cleaning and Disinfecting Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide. The graphics below are a visual representation of the wiping procedure for disinfection. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...
  • Page 108 Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

  • Page 109: Manufacturer's Quality System Instructions

    (results reporting and communication). There may be additional accreditation organization requirements and individual codes, statutes, or regulations which are not addressed here. i-STAT Alinity — System Operations Manual Art: 745532-01 Rev.D Rev. Date: 04-Mar-2021...
  • Page 110 Alinity — System Operations Manual Art: 745532-01 Rev.D Rev. Date: 04-Mar-2021...

  • Page 111: Liquid Quality Controls

    ReVAS. ReVAS ranges are provided as a feature for the German market and for those customers who prefer ranges set using Rilibak guidelines. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...
  • Page 112 Electronic value assignment sheets (eVAS or ReVAS) may be downloaded to a customized instrument via the Abbott Managed Server, the SDi, or USB. See the System Operations Manual for information and instruction on creating customization profiles. Selection of eVAS or ReVAS must be made during the creation of the profile.
  • Page 113 Reactive ingredients for i-STAT Control materials: Analyte Control Level 1 Control Level 2 Control Level 3 Na (mmol/L) K (mmol/L) Cl (mmol/L) Glu (mmol/L) Urea (mmol/L) iCa (mmol/L) Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...
  • Page 114 Na is the analyte tested, Na (Sodium). mmol/L, mEQ/L are the units of measurement. Mean is the mean or average level of sodium (Na). Range is the acceptable range of sodium (Na) levels. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...

  • Page 115: I-Stat Act Controls

    (18 to 30°С or 64 to 86°F) for a minimum of 45 minutes. • i‑STAT ACT Control testing must be performed IMMEDIATELY (less than 30 seconds) AFTER COMPLETING THE RECONSTITUTION AND MIXING STEPS. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...
  • Page 116 4. Place the end of the transfer device into the sample well of the cartridge and fill the cartridge to the fill mark. 5. Close cartridge and begin testing immediately. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...

  • Page 117: Calibration Verification (Cal Ver)

    Any variations in instrument performance will not be statistically discernable above the performance of the cartridges. When multiple instruments are to be used at a facility, Abbott Point of Care Inc. recommends including at least two instruments in any performance verification studies so that statistics reflect the “system.”...

  • Page 118: Calibration Verification Testing And I-Stat Tricontrols Calibration Verification Solutions

    , PO , iCa. Ranges Assigned ranges are provided in the form of value assignment sheets (VAS). These are located on https:// www.globalpointofcare.abbott/en/support/istat-brand/istat-alinity.html. Abbott Point of Care makes Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...
  • Page 119 Electronic value assignment sheets (eVAS or ReVAS) may be downloaded to a customized instrument via the Abbott Managed Server, the SDi, or USB. See the System Operations Manual for information and instruction on creating customization profiles. Selection of eVAS or ReVAS must be made during the creation of the profile.
  • Page 120 Cal Ver Level 2 Cal Ver Level 3 Cal Ver Level 4 Cal Ver Level 5 Na (mmol/L) K (mmol/L) Cl (mmol/L) Glu (mmol/L) Urea (mmol/L) 44.6 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...
  • Page 121 The following is an example of the mean and range for level 2 Cal Ver solution taken from a Value Assignment Sheet: Mean Range Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...
  • Page 122 Na is the analyte tested, Na (Sodium). mmol/L, mEQ/L are the units of measurement. Mean is the mean or average level of sodium (Na). Range is the acceptable range of sodium (Na) levels. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...

  • Page 123: I-Stat Cartridges

    Invalid Cartridge Type. • Customization may affect analyte availability. • For access to cartridge-specific Instructions for Use (IFU) and analyte-specific CTI Sheets, access the Support page on the Abbott Point of Care website www.globalpointofcare.abbott. Cartridge Specifications Shelf Life: Refrigerated at 2ºC to 8ºC (35ºF to 46ºF) until expiration date.
  • Page 124 Cartridge Box Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 125 Cartridge Pouch Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 126 Cartridge Portion Pack Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

  • Page 127: I-Stat Cartridge Components

    Improper handling may damage the cartridge and result in a Cartridge Quality Check Failure instead of results. • Dispose of used cartridges as biohazardous waste. Follow facility policy for disposal. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 128 Sample Well The area on the cartridge where the sample is introduced into the sample chamber. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 129 Potentiometric sensors utilize two important concepts. The first concept is the Nernst Equation which relates the measured potential to the activity of the ion being measured. It is written as: E = E° + RT/nF ln a Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 130 3. The measured signal generated by the analyte in the test solution For potentiometric sensors, the analyte activity in the sample is calculated from the Nernst equation according to: = S log (a sample calibrant sample calibrant Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 131 (Nikolsky equation), these effects can be minimized. By characterizing the reference electrode in different solutions, effects of matrix on the reference junction potential can also be minimized. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

  • Page 132: Receiving A New Shipment Of Cartridges

    • attempt to remove the cartridge while the message Cartridge Locked in instrument. Do not attempt to remove the cartridge. remains on the screen. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 133 • The instrument and its peripherals are not listed by any authority with respect to suitability for use in oxygen-enriched atmospheres. • Follow manufacturer's recommendations for handling and storing samples drawn into lithium or balanced heparin. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
  • Page 134 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

  • Page 135: Software Updates

    1.13 - Software Updates Software updates to the i-STAT Alinity instrument are delivered twice a year. Each software update contains two elements in a single package: CLEW software and application software. These updates may be downloaded and installed in one of three ways: 1.
  • Page 136 The display of this message is the indication that the installation is complete and it is safe to remove the instrument and USB memory device from the Base Station. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 137 Note: It is recommended that Electronic Simulator Test be completed immediately following a software update. Depending on the instrument customization, testing may be disabled until an Electronic Simulator Test with passing result is completed. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 138 Alinity system. Before reformatting, make sure you copy any files on the USB memory device to a safe location on your PC because reformatting will delete all files from the memory device. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...

  • Page 139: Software Update And Installation Via Abbott Managed Server Or The Aliniq Sdi, And A Wired Network Connection

    Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wired Network Connection Use this procedure to update the instrument software using a wired connection to Abbott’s Managed Server or the SDi. Note: • The healthcare organization network must allow instruments to connect to the Abbott Managed Server or an SDi server.
  • Page 140 7. When the installation is complete, the instrument will display a message indicating that new software has been installed. The display of this message is the indication that it is safe to resume normal operation of the instrument. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 141 • Remove the instrument and re-seat it on the Battery status indicator does not indicate battery is charging Base Station • Ensure the Base Station is getting power (Blue light on Base Station is illuminated) Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 142 • The healthcare organization network is allowing the instrument to connect to the internet in order to have access to the Abbott Managed Server or SDi. Repeated attempts to update software via wired Follow the procedure to perform software update...

  • Page 143: Software Update And Installation Via Abbott Managed Server Or The Aliniq Sdi, And A Wireless Network Connection

    Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wireless Network Connection Use this procedure to update the instrument software using a wireless connection to Abbott’s Managed Server or the SDi. Note: • The healthcare organization network must allow instruments to connect to the Abbott Managed Server or an SDi.
  • Page 144 7. When the installation is complete, the instrument will display a message indicating that new software has been installed. The display of this message is the indication that it is safe to resume normal operation of the instrument. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 145 • The instrument is running software version OSi05 or later • Network Services for software update enabled on instrument • The battery charge level is no less than 51% Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
  • Page 146 Network Configuration file installed • The healthcare organization network is allowing the instrument to connect to the internet in order to have access to the Abbott Managed Server or to connect to the SDi Repeated attempts to update software via wireless...
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  • Page 149: Aliniq Nci - Network Connectivity For I-Stat

    The Network Connectivity utility for i‑STAT (AlinIQ NCi) is used to configure the instrument to connect to wired and wireless networks. The NCi utility package must be downloaded from the Abbott Point of Care website. It is best practice to load NCi onto a computer that is installed behind the healthcare facility's firewall, and that has antivirus software installed on it.
  • Page 150 Installing NCi: • Navigate to the Abbott Point of Care website • Find the link to the NCi utility • Follow the instructions on the screen When the installation of NCi completes, this icon will appear on the desktop: To run NCi, double click the icon. On the first screen of the NCi that displays, select the type of instrument as i‑STAT Alinity.

  • Page 151: Aliniq Nci - General Section

    Serial number of the instrument to which this NC file applies. When a serial number is specified, the NC file name will include it, as shown here: DefaultConfig.snnnnn.ancc Configuration Name i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 152 Click this option to edit an existing NC file. Navigate to the folder containing the NC file you wish to edit. The next section of the NCi screen is for configuring a connection to a proxy server. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 153: Aliniq Nci - Proxy Server Connection

    Proxy server information is required if the instrument is to connect to the internet via a proxy server. This may be required to download eVAS directly from Abbott Point of Care to the instrument via the internet. My network uses a proxy server to access the internet...
  • Page 154 The next section of the NCi screen is for connecting wirelessly. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 155: Aliniq Nci - Wireless Network Connection

    This section of the screen is used to configure connectivity to a wireless network. Some of the options displayed on the screen depend upon the authentication type, and are noted as such. I want the i-STAT Alinity to connect to my facility's WIRELESS network Select this check box to configure wireless network connectivity.
  • Page 156 IP Address IPv4 address of instrument in decimal dot notation. Example: 172.16.254.1 ￮ Subnet Mask IPv4 mask that defines the Subnet in decimal dot notation. Example: 255.255.255.0 i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 157 Name of the file that contains the Certificate Authority certificate. Client Certificate File Name of the file that contains the client certificate. Client Key File Name of the file that contains the client key. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 158 Client Key Password Password for the client key. Username/Identity Username required by the authentication server. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 159: Aliniq Nci - Wired Network Connection

    • Use the following IP Address - Select this button to use a static IP address. Note: If you specify a static IP address you must also specify DNS addresses. IP Address IPv4 address of instrument in decimal dot notation. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 160 IPv4 address of the server in decimal dot notation Alternate DNS: IPv4 address of the server in decimal dot notation. Note: You must specify DNS addresses if you specify a static IP address. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 161: Aliniq Nci - Save The Network Connectivity (Ancc) File

    Note: If you use this option make note of the destination where the file is saved. This information will be needed to load the ancc file onto the USB memory stick. Save and open Not recommended. Cancel Do not save the file. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 162: Aliniq Nci - Copy Nc (Ancc) File Onto A Usb Memory Stick

    3. Touch More Options 4. Touch Instrument Options 5. Touch Network Settings 6. Install Network Settings 7. Enter Operator ID, touch Next 8. Follow instructions on the i‑STAT Alinity screen. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

  • Page 163: Aliniq Nci - Customization And Connectivity

    A location that displays the symbol with all bars empty represents no signal. If the symbol displays with all bars empty, move the instrument to a location closer to the wireless access point. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 164 Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
  • Page 165 Network Connectivity for i-STAT Alinity Worksheet 1 of 2 1A - The configuration will be used for: Multiple instruments Enter a name for configuration (maximum 53 characters) 1D Configuration Name: 2A - Using a Proxy Server to Access Internet 2B Select either HTTP or Socks HTTP Yes/No Socks Yes/No Enter IP address and port of the proxy server 2C Proxy Server Address: Port: 2D Proxy Server User Name: 2E Proxy Server Password: If connection to a Wireless Network is required, complete information below 3A - Connect to Wireless Enter Name of the wireless local area network (WLAN) 3B Network Name (SSID): If connection to a single access point is required, Enter BSSID 3C Connect to a specific Access Point (BSSID): 3D Authentication Type: For Personal Authentication, select one of the following options PERSONAL WPA Personal Yes/No WPA2 Personal Yes/No WPA2/WPA Personal Yes/No Enter PSK Passphrase (8 to 63 characters), or 64-digit HEX key 3E Network Security Key: Select either Automatic (DHCP) or Static IP Address Option 3F IP Address Mode: Automatic (DHCP) Yes/No Static IP Address Yes/No If Static IP Address Option is selected, enter IP Address, Subnet Mask and Optional Default Gateway 3G IP Address: 3H Subnet Mask:...
  • Page 166 Network Connectivity for i-STAT Alinity Worksheet 2 of 2 For Enterprise Authentication, select one of the following options Enterprise WPA Personal Yes/No WPA2 Personal Yes/No WPA2/WPA Personal Yes/No Select one of three EAP Methods and complete security credential information for selected option 3N EAP Method TLS TTLS/MSCHAPv2 PEAPv0/EAP-MSCHAPv2 3O Server Name: Server Name: Server Name: 3P CA Certificate File: CA Certificate File: CA Certificate File: 3Q Client Certificate File: Client Certificate File: Username/Identity: 3R Client Key File: Client Key File: Password: 3S Client Key Password: Client Key Password: Anonymous ID: anonymous 3T Username/Identity: Username/Identity: Password: Anonymous ID: anonymous If connection to a Wired Network is required, complete information below 4A - Connect to Wired 4B Authentication Type: open 4C IP Address Mode: Automatic (DHCP) Yes/No...
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  • Page 169: Aliniq Cwi - Customization Workspace For I-Stat

    This section contains a general description of the CWi (Customization Workspace for i‑STAT). i‑STAT Alinity instruments can be customized for use in a variety of healthcare settings. Abbott Point of Care recommends that you read this document in its entirety before logging in to CWi. Specifics on the functions and features are outlined in the following sections.

  • Page 170: Best Practices

    "best practices". They are intended only as examples. Each HCO should establish its own best practices. How to Proceed Begin by contacting Abbott Point of Care and establishing your Healthcare Organization (HCO) (refer to the next section, Getting Started). Next, define the primary CWi user (refer to the section Manage Users).
  • Page 171 In order to ensure the security of users' customizations, profiles and other data, Abbott Point of Care establishes the healthcare organization (HCO). This is done once. At the time the HCO is created, an HCO primary manager must be identified. The HCO primary manager is the person responsible for the CWi.
  • Page 172 On the Home page, next to the 'Welcome' is the email address of the user who is logged on. Next to the email address is a " " gear icon. Click on the icon to open the User Settings screen. The password and i-STAT Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...
  • Page 173 4. Enter the password created by the user and click the "Log in" button. If 5 failed attempts are made, the system will lock out the user. The lockout will last for one hour, unless the user resets their password. i-STAT Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...

  • Page 174: Cwi - Home Page

    CWi - Home page The Home page is the first screen displayed after you log in to CWi. The CWi Home page consists of the following: i-STAT Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...
  • Page 175 Displays the email address of the user who Email address of user is logged on and the name of the Healthcare Organization only HCO Name as assigned by Abbott Point of Care Command Provides link for password to be changed Line and language chosen.
  • Page 176 Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...

  • Page 177: Manage Healthcare Organization

    Organization workspace to ensure that the information for your healthcare organization is correct. In order to ensure the security of profiles and other data, Abbott Point of Care establishes a unique identifier for each healthcare organization. This is done once. At the time the healthcare organization is created, the Primary Healthcare Organization manager must be identified.

  • Page 178: Best Practices

    Each healthcare organization should establish its own best practices. Getting Started The healthcare organization information required by Abbott Point of Care includes: • name of the healthcare organization • city •...

  • Page 179: Manage Users

    • One healthcare organization manager is specified as the "primary" and indicated in the Manage User list with a check mark (✓). To change the primary healthcare organization manager, contact Abbott Point of Care technical support by email: oustechsvc@apoc.abbott.com.

  • Page 180: Getting Started

    • Delete - Delete a CWi user • Back - Go back to previous page To create a user, in the upper right corner of the screen, click Create. This screen displays: i-STAT Alinity — System Operations Manual Art: 746303-01 Rev. K Rev. Date: 19-Oct-2021...
  • Page 181 Healthcare Organization Manager Point of Care Super User Point of Care Coordinator To delete these specifications, click Discard. To save them, Click Next and the Summary tab displays. i-STAT Alinity — System Operations Manual Art: 746303-01 Rev. K Rev. Date: 19-Oct-2021...
  • Page 182 The Search field is used to find free-field text (i.e. email addresses or user names) in the User Workspace table. The Filter option is used to limit what is displayed in the User Workspace table. i-STAT Alinity — System Operations Manual Art: 746303-01 Rev. K Rev. Date: 19-Oct-2021...

  • Page 183: Manage And Assemble Profiles

    The Filter option is used to limit what is displayed in the Workspace table. These functions are available for all categories in the Manage and Assemble Profiles Workspace. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 184: Best Practices

    • Print the Laboratory Reference and Action (Critical) ranges - including units of measure for each analyte that will be used on the i-STAT Alinity. This can minimize the time needed to build the Analyte Settings Unit and Range feature.

  • Page 185: Creating A Category

    Note: Profiles are created by assembling categories. When creating profiles for the first time, it is necessary to create categories first. Details on each category are in the following sections. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 186 ￮ Search for Operator ID on Operator List ￮ Operator ID on Operator List-Certification Expired Action ￮ Operator ID not on Operator List Action • Operator Expiration ￮ Operator Certification Expiration Notification Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 187 ￮ Apply CPB Protein Algorithm to Hematocrit Setting • Adjustments ￮ BE Equation ￮ eGFR Equation ￮ eGFR Variants • ACT ￮ ACTk Mode ￮ Stop ACT Test • Critical Tests Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 188 ￮ Manage Items ￮ Manage Sets Connectivity Settings • Connectivity Map ￮ Test Records ￮ Device Events ￮ Operator List ￮ Patient List ￮ Cartridge List ￮ Log Events Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 189: General Settings Category

    When finished, choose from the actions shown at the bottom of the screen: • Discard - to undo changes • Next - to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 190: Basic Functions

    Update and install software After the software update is downloaded from the Abbott Managed from Server Server, or the SDi, the instrument will install the software without requiring the installation confirmation.
  • Page 191 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 192: Date

    Date These settings control the format of the date when it is entered and displayed on the i-STAT Alinity. Date Entry Select one of these options for the format to be used when entering the date into the instrument. The default is mm/dd/yy:...

  • Page 193: Communications

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 194: Operator Actions

    20 characters will be displayed and available for attaching to a rejected result. A maximum of 6 comments can be displayed with a text box. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 195 Operator selects the most appropriate. Rejection comments will be attached to the test record and can be viewed under the Review Results > Patient Results > Rejected Patient Results Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 196 Mandatory Prompt the operator for a mandatory entry. Cartridge testing cannot continue until information is entered. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 197 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 198 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 199: Critical Callback

    Allow barcode scan or manual data entry. Scan Only Allow barcode scan data entry only. Manual Entry Only Allow manual data entry only. Minimum Length Enter the minimum data characters allowed. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 200 Use the Mod 11 algorithm when creating entry operator or patient IDs. Mod 10 check digit on manual Use the Mod 10 algorithm when creating entry operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 201 Patient Last Name. See the information Minimum Length shown earlier in this section. Maximum Length Scan Mask Manual Check Digit Method Scan Entry Check Digit Method Barcode Type Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 202 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 203: Print

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 204: I-Stat Reserved

    Reserved For Abbott Point of Care use only and to be used only at the direction of Abbott Point of Care. Summary The Summary is a collapsed view of the settings that can be expanded to provide a complete display. The Summary should be reviewed prior to Publish.

  • Page 205: Operator Settings Category

    When finished, choose from the actions shown at the bottom of the screen: • Discard - to undo changes • Next - to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 206 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 207 Display the entire operator ID. Partially Display Operator ID Display only the last 3 digits of the operator ID. Hide Operator ID Display none of the operator ID. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 208 • Previous to go back to the screen displayed previous to this screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 209: List Actions

    Lockout user Deny access if an operator's certification is expired. Test Pathways other than Determine an operator's access if the Training or Unscheduled operator's certification has expired. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 210 Operator List and allow access to the test pathway for testing to be performed. Lockout user Deny access if an operator's ID is not on the Operator List. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 211 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 212: Operator Expiration

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 213: Patient Settings Category

    When finished, choose from the options shown at the bottom of the screen: • Discard to undo changes • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 214: Id Entry

    Allow barcode scan data entry only. Manual Entry Only Allow manual data entry only. Minimum Length Enter the minimum data characters allowed. Maximum Length Enter the maximum data characters allowed. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 215 Whether to use a check digit when scanning a value to create an operator or Method patient ID. No check digit on scan entry Do not use a check digit when creating operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 216 IDs. Mod 10 check digit on scan Use the Mod 10 algorithm when creating entry operator or patient IDs. Barcode Type Select all that apply. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 217: Patient Information And Positive Patient Identification (Ppid)

    Select this option to require user to repeat patient ID entry in order to proceed with patient testing. Prohibit testing Select this option to prohibit patient testing. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 218: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 219: Analyte Settings Category

    When finished, choose from the options shown at the bottom of the screen: • Discard to undo changes • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 220: Units

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 221: Sample Types

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 222: Ranges

    To customize action range(s), click on Add Range under the Action Range section. The same structure is in place for changing action range as it is for reference range. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 223 Note: Never enter a null (blank) value for the Custom Reportable range for Low or High. The values can be left as -99999.9 for Low or 99999.9 for High. Note: Range customization may not apply to all cartridge types. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 224 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 225: Enable/Disable Analyte

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 226: Hematocrit

    Apply CPB correction every time a cartridge with a hematocrit sensor is used. CPB, never apply Do not apply CPB correction when running a cartridge with a hematocrit sensor. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 227 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 228: Adjustments

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 229: Act (Activated Clotting Time)

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 230: Critical Tests

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 231: Quality Settings Category

    When finished, choose from the actions shown at the bottom of the screen: • Discard to undo changes • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 232: Electronic Simulator

    Specify a number of days in the range 0 - 365. The default is 0, which turns off testing. Note: Abbott Point of Care manufacturer's requirement is for the electronic simulator to be tested every 6 months (182 days).

  • Page 233: Qc Notifications

    The following symbol <> is displayed next to each Liquid QC test name in place of the quantitative (numeric) results. Do not select this option if manual pass/fail determination is selected. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 234 A list of comments created by the CWi user. Operator selects the most appropriate. The comment will be attached to the test record. Each comment can be 20 characters in length including spaces. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 235 USB port on the Base Station. Manual The operator manually compares the Cal Ver results to a Value Assignment Sheet downloaded or printed from the Abbott Point of Care website at: https:// www.globalpointofcare.abbott/en/support/ istat-brand/vas-i-stat-alinity.html...
  • Page 236 The file type uploaded onto the i‑STAT Alinity for the use of the Pass/Fail Determination feature. Select either: eVAS Select for all countries except Germany. ReVAS Select only if you are in Germany. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 237 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 238: Liquid Qc (Quality Control) Schedules

    Select which months to perform testing. Any or all months of the year can be selected. Cartridge QC Profile If Frequency is specified, define at least one Cartridge QC Profile. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 239 Cartridge QC Profile cannot be a dependent cartridge in another Cartridge QC Profile within the same schedule. It can be a dependent cartridge in a Cartridge QC Profile belonging to a different schedule. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 240 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 241: Cal Ver Schedules

    Cartridge QC Profile If Frequency is specified, define at least one Cartridge QC Profile. Add QC Profile Click Add QC Profile. This panel displays: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 242 QC Fluids Select up to 6 different fluids in 1 QC schedule. Selections must not be duplicated. After fluids have been selected, click Update QC Profile. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 243: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 244: User Defined Message Category

    • Previous to go back to the screen displayed previous to this screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 245: Summary

    When finished, choose from the options shown at the bottom of the screen: • Discard to undo changes • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 246: Basic Functions

    PPID feature in Patient Settings must be enabled. • For analyte values to display as critical, abnormal, or normal values, reference and action ranges in Analyte Settings are required. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 247 On the screen that displays, enter values for the scenario you are creating. When all information has been entered, click Update Training Scenario. The scenario that was created displays on a screen similar to the one shown here: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 248: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 249: Statnotes Category

    The following item types are available: Data Entry, Selection List, Selection List with text box, Delivery System, Mode and Patient Temperature. Each of these choices is detailed below. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 250 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 251: Data Entry

    Data Entry This section describes creating a Data Entry item that will prompt the operator to supply information, either using the keypad or by scanning. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 252 Determine the format used to enter data. Select either: Numeric Only Data will be entered only as numbers. Alphanumeric Data will be entered as either letters or numbers. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 253 ID numbers, and if so, which algorithm is used. Allowable values are: No check digit on manual Do not use a check digit when creating entry operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 254 When the specifications for this item are complete, in the lower right corner of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 255: Selection List

    Example of selection list item displayed on the i‑STAT Alinity: The operator is prompted to choose one of the selection list responses. After all selection list items have been created, click Update Selection List or Cancel. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 256 • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 257: Selection List With Text Box

    After all selection list items have been created, click Update Selection List or Cancel. • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 258: Mode

    Table 3–2: Modes (Examples Only) Mode STATNotes Items Set Rate FIO2 PEEP Heliox Set Rate FIO2 PEEP Heliox CPAP FIO2 PEEP Heliox HFOV Delta P Bias Flow FIO2 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 259 Prompt the operator for a mandatory entry. If the override feature is chosen by the operator no further action is required and the instrument will advance to the next screen. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 260 Repeat this process for all STATNotes items that will be needed for the ventilator mode that is being built. Once all STATNotes items have been selected for the ventilator mode click Save. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 261 When finished, choose from the options shown at the bottom of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 262: Delivery System

    Required. Specify a name that is from 1 to 20 characters long and: • does not begin with the characters APOC (in upper or lower case) • is a unique name within this healthcare organization. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 263 The delivery system does not have settings or measurements. Example: Room Air. Once No Page is selected, click Save. Mode The delivery system has various modes. Example: Ventilator. Once Mode is selected, click Save. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 264 When finished, choose from the options shown at the bottom of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 265: Patient Temperature

    When finished, choose from the options shown at the bottom of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 266: Manage Sets

    When finished, choose from the options shown at the bottom of the screen: • Click Publish to create the set • Click Discard to delete the set After a STATNotes set has been published, click Done. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 267 When finished, choose from the options shown at the bottom of the screen: • Next to open the next tab for this Category • Discard to undo changes Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 268: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 269: Result Notes Category

    The following item types are available: Data Entry, Selection List, Selection List with text box, Repeat Test, Action Range Comment and QC Auto Fail Comment. Each of these choices is detailed below. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 270: Data Entry

    Prompt the operator for a mandatory entry. If the override feature is chosen by the operator no further action is required and the instrument will advance to the next screen. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 271 Entry, mandatory Prompt the operator for a mandatory entry. Cartridge testing cannot continue until information is entered. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 272 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 273 When the specifications for this item are complete, choose from the options in the lower right corner of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 274: Selection List

    Click Edit Selection List. A text box displays: Enter up to 20 characters in the text box. This will be the first item in the selection list. To create additional items, click Add Item. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 275 • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item The Result Notes Item Name list displays and now includes the Selection List item that was just created. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 276: Selection List With Text Box

    After all selection list items have been created, click Update Selection List or Cancel. • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 277: Repeat Test Item

    Under Selection List the values Yes and No are shown. These are the only possible responses displayed on the instrument. • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 278: Action Range Comment

    Click Edit Selection List. A text box displays: Enter up to 20 characters in the text box. This will be the first item in the selection list. To create additional items, click Add Item. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 279: Qc Auto Fail Comment

    Prompt the operator for a mandatory entry. Cartridge testing cannot continue until information is entered. Each item for the selection list is defined next. Click Edit Selection List. A text box displays: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 280: Manage Sets

    Control and Cal Ver pathways Apply Result Notes when performing Control or Cal Ver testing. Next, in the upper right corner of the screen, click Create Set. Result Notes Set Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 281 ￮ underscore ( _ ) • does not begin with the characters APOC (in upper or lower case) • is a unique name within this healthcare organization Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 282 Description Optional. When finished, choose from the options shown below: • Next to open the next tab for this Category • Discard to undo changes. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 283: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 284: Connectivity Settings Category

    When finished selecting values, choose from the options shown below: • Next to open the next tab for this Category • Discard to undo changes. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 285: Connectivity Map

    Log Events For each remote system mapped, the following information is needed: • Reviewer Name - information system name, for example, InfoHQ • Vendor Name - for example, Abbott Point of Care • IP Address • Network Port Instrument Clock Date/Time Synchronization...

  • Page 286: Summary

    • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Publish to make settings available to use in a Profile Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 287: Assemble A Profile

    • is a unique name within this healthcare organization Description Provide any information that helps the user know how or why the profile was named or created. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 288 Optional categories may also be selected for the profile. When selections are complete, choose from the options shown at the bottom of the screen: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 289: Install A Profile From A Usb

    • check to ensure the Base Station is getting power (blue light illuminated) If the instrument does not detect the USB drive, try the following: • remove the USB and reinsert • make sure the USB is formatted Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
  • Page 290 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

  • Page 291: Aliniq Cwi - Customization Workspace For I-Stat Troubleshooting

    Check Barcode settings in the Operator Settings ID Entry feature on the profile assigned to the instrument. Follow CWi instructions in this manual to change the barcode type. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
  • Page 292 Patient List from the data management system. Check the Connectivity Settings Category to confirm the IP address is programmed for Patient List. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
  • Page 293 Follow the instructions in this manual to set Auto via eVAS or Manual. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
  • Page 294 Best practice would be to save all assigned profiles in a file on a healthcare organization manager's computer. If a profile needs to be loaded onto an instrument while the system is down, upload can be i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H...
  • Page 295 USB. Temporary loss of user access to AlinIQ CWi will not affect profiles already loaded onto instruments. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
  • Page 296 Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...

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