System Operations Manual
402 Pages
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Trademarks i-STAT and Alinity are trademarks of the Abbott Group of Companies in various jurisdictions. Windows is a registered trademark of Microsoft Corporation.
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©2018 Abbott Point of Care Inc. All rights reserved. Printed in USA.
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Table of Contents Foreword
ix
i-STAT® ALINITY INSTRUMENT - END USER LICENSE AGREEMENT............................... x
Regulatory compliance Symbols Definitions and Terminology
xv xxv xxxi
1 - i-STAT Alinity Reference.................................................................................. 1 1.1 - Complete i‑STAT Alinity System Overview
3
1.2 - i-STAT Alinity Instrument
7
Principles of Operation.............................................................................................................8 More Options..........................................................................................................................10 Calibration of the i-STAT Alinity instrument........................................................................17 Specifications......................................................................................................................... 18 Wireless Labeling........................................................................................................18 Precautions and Limitations................................................................................................... 19 Messages and Troubleshooting ............................................................................................. 21 Quality Check Failure Codes................................................................................................. 22 Cleaning and Disinfecting......................................................................................................32
1.3 - i-STAT Alinity Results Screen
33
1.4 - i-STAT Alinity Rechargeable Battery
37
1.5 - i-STAT Alinity Base Station
41
1.6 - i-STAT Alinity Electronic Simulator
45
Principles of Operation...........................................................................................................37 Specifications......................................................................................................................... 38 Precautions and Limitations................................................................................................... 38
Specifications......................................................................................................................... 42 Precautions and Limitations................................................................................................... 43 Troubleshooting .................................................................................................................... 44 Cleaning and Disinfecting......................................................................................................44
Principles of Operation...........................................................................................................45 Specifications......................................................................................................................... 46 Precautions and Limitations................................................................................................... 46 Cleaning and Disinfecting......................................................................................................47
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1.7 - Perform Electronic Simulator Testing
49
1.8 - i-STAT Alinity Printer
51
1.9 - Manufacturer's Quality System Instructions
57
1.10 - Liquid Quality Controls
59
1.11 - Calibration Verification (Cal Ver)
69
1.12 - i-STAT Cartridges
75
1.13 - Software Updates
83
1.14 - i-STAT Alinity Charge Station
95
Perform the Thermal Probe Check.........................................................................................50
Principles of Operation...........................................................................................................52 Specifications......................................................................................................................... 52 Precautions and Limitations................................................................................................... 53 Troubleshooting..................................................................................................................... 54 Cleaning and Disinfecting......................................................................................................56
i-STAT Controls.....................................................................................................................59 i‑STAT Controls testing......................................................................................................... 60 i-STAT Solutions................................................................................................................... 61 i-STAT TriControls................................................................................................................62 i‑STAT TriControls Control testing....................................................................................... 63 i-STAT TriControls Control Solutions.................................................................................. 64 ACT Controls......................................................................................................................... 65 ACT Controls testing............................................................................................................. 66 ACT Solutions........................................................................................................................67 Evaluating QC Results........................................................................................................... 67
Calibration Verification testing..............................................................................................70 i-STAT Calibration Verification (Cal Ver) Solutions............................................................73
Principles of Operation...........................................................................................................75 Receiving a New Shipment of Cartridges.............................................................................. 80 Specifications......................................................................................................................... 80 Precautions and Limitations................................................................................................... 81
Software Update and Installation using USB memory device via Base Station....................83 Software Update and Installation via Abbott Managed Cloud (Server) Wired Network Connection....................................................................................................................87 Software Update and Installation via Abbott Managed Cloud (Server) Wireless Network Connection.....................................................................................................91
Light Indicators...................................................................................................................... 96
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Specifications......................................................................................................................... 97 Software Update.....................................................................................................................98 Precautions and Limitations................................................................................................... 99 Troubleshooting .................................................................................................................. 100 Cleaning and Disinfecting....................................................................................................102
2 - AlinIQ Network Connectivity for i-STAT (NCi).........................................105 2.1 - AlinIQ NCi - Network Connectivity for i‑STAT
107
AlinIQ NCi - General Section..............................................................................................109 AlinIQ NCi - Proxy Server Connection............................................................................... 111 AlinIQ NCi - Wireless Network Connection....................................................................... 113 AlinIQ NCi - Wired Network Connection........................................................................... 117 AlinIQ NCi - Save the Network Connectivity (ancc) file ...................................................119 AlinIQ NCi - Copy NC (ancc) file onto a USB memory stick............................................ 120 AlinIQ NCi - Upload an NC (ancc) file to an instrument.................................................... 120 AlinIQ NCi - Customization and Connectivity....................................................................121 AlinIQ NCi - Determining Success or Failure..................................................................... 121
3 - AlinIQ Customization Workspace for i-STAT (CWi)................................ 123 3.1 - AlinIQ CWi - Customization Workspace for i-STAT
125
3.2 - Manage Healthcare Organization
131
3.3 - Manage Users
133
3.4 - Manage and Assemble Profiles
137
Workspaces ......................................................................................................................... 125 Best Practices....................................................................................................................... 126 Getting Started .....................................................................................................................127 CWi - Home page.................................................................................................................130
Overview - Healthcare Organization....................................................................................131 Best Practices....................................................................................................................... 132 Getting Started......................................................................................................................132
Overview.............................................................................................................................. 133 Best Practices....................................................................................................................... 133 Getting Started......................................................................................................................134
Best Practices....................................................................................................................... 138 Creating a Category..............................................................................................................139 *General Settings Category..................................................................................................143 Basic Functions......................................................................................................... 143 Date........................................................................................................................... 145 Communications........................................................................................................145
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Operator Actions....................................................................................................... 146 Critical Callback........................................................................................................149 Print........................................................................................................................... 155 i-STAT Reserved.......................................................................................................156 Summary................................................................................................................... 156 *Operator Settings Category................................................................................................ 157 List Actions............................................................................................................... 160 Operator Expiration...................................................................................................162 Summary................................................................................................................... 162 *Patient Settings Category................................................................................................... 163 ID Entry.....................................................................................................................163 Positive Patient Identification (PPID)....................................................................... 166 Basic Functions ........................................................................................................ 167 Summary................................................................................................................... 167 *Analyte Settings Category..................................................................................................168 Units.......................................................................................................................... 168 Sample Types............................................................................................................ 169 Ranges....................................................................................................................... 169 Enable/Disable Analyte.............................................................................................171 Hematocrit................................................................................................................. 172 Adjustments...............................................................................................................173 ACT (Activated Clotting Time)................................................................................ 173 Critical Tests..............................................................................................................174 Summary................................................................................................................... 174 *Quality Settings Category ................................................................................................. 175 Electronic Simulator..................................................................................................175 QC Notifications .......................................................................................................176 Liquid QC (Quality Control) Schedules....................................................................180 Cal Ver Schedules..................................................................................................... 184 Summary................................................................................................................... 186 User Defined Message Category .........................................................................................187 Summary................................................................................................................... 187 Training Settings Category...................................................................................................188 Basic Functions......................................................................................................... 189 Summary................................................................................................................... 191 STATNotes Category...........................................................................................................192 Data Entry .................................................................................................................193 Selection List ............................................................................................................196 Selection List with Text box..................................................................................... 197 Mode..........................................................................................................................197 Delivery System........................................................................................................ 201 Patient Temperature.................................................................................................. 205 Manage Sets.............................................................................................................. 206 Summary................................................................................................................... 208 Result Notes Category..........................................................................................................209 Data Entry .................................................................................................................210 Selection List.............................................................................................................212 Selection List with Text box..................................................................................... 213 Repeat Test Item........................................................................................................214 Action Range Comment............................................................................................ 216
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QC Auto Fail Comment............................................................................................ 217 Manage Sets.............................................................................................................. 218 Summary................................................................................................................... 220 Connectivity Settings Category............................................................................................221 Connectivity Map...................................................................................................... 222 Summary................................................................................................................... 222 Assemble a Profile .............................................................................................................. 223 Install a Profile from a USB.................................................................................................225
3.5 - AlinIQ CWi – Customization Workspace for i-STAT Troubleshooting
227
4 - Cartridge and Test Information................................................................... 231 4.1 - Cartridge and Test Information
233
4.2 - Technical Bulletin - Supplemental Test Information for the i‑STAT Alinity System
251
Cartridge Specifications....................................................................................................... 233 Expected Values........................................................................................................ 248
Specific Performance Characteristics - SODIUM............................................................... 252 Specific Performance Characteristics - POTASSIUM.........................................................254 Specific Performance Characteristics - HEMATOCRIT..................................................... 256 Specific Performance Characteristics - LACTATE............................................................. 258 Specific Performance Characteristics - pH.......................................................................... 260 Specific Performance Characteristics - PCO2..................................................................... 262 Specific Performance Characteristics - PO2........................................................................ 264 Specific Performance Characteristics - CHLORIDE........................................................... 266 Specific Performance Characteristics - IONIZED CALCIUM............................................268 Specific Performance Characteristics - GLUCOSE.............................................................270 Specific Performance Characteristics - BUN.......................................................................272 Specific Performance Characteristics - CREATININE and ESTIMATED GLOMERULAR FILTRATION RATE.................................................................... 274 Specific Performance Characteristics - TCO2..................................................................... 277 Specific Performance Characteristics - Kaolin Activated Clotting Time (KaolinACT) ....... 279 REFERENCES.....................................................................................................................283
CTI (Cartridge and Test Information) Sheets SODIUM POTASSIUM HEMATOCRIT LACTATE pH PCO2 PO2 CHLORIDE IONIZED CALCIUM i-STAT Alinity — System Operations Manual
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GLUCOSE BUN CREATININE AND ESTIMATED GLOMERULAR FILTRATION RATE TCO2 Kaolin Activate Clotting Time (Kaolin ACT)
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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.
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i-STAT® ALINITY INSTRUMENT - END USER LICENSE AGREEMENT Please read the EULA prior to using this device. Your use of the device is conditioned upon your acceptance of the terms of the EULA. Any use of this device shall indicate your acceptance of the terms of the EULA. If you do not accept the terms of the EULA, do not use this device. The Software, and all intellectual property rights therein, is owned by APOC and its licensors. You may not (i) use the Software to access or attempt to access any other APOC systems, programs or data that are not made available for public use; (ii) copy, reproduce, alter, merge, modify, adapt, translate, republish, upload, post, transmit, resell or distribute in any way the Software (or the Devices) or decompile, reverse engineer, disassemble, or otherwise reduce the Software to a human perceivable form; (iii) permit any third party to benefit from the use or functionality of the Software via a rental, lease, timesharing, service bureau, or other arrangement; (iv) transfer any of the rights granted to you under this EULA; (v) work around any technical limitations in the Software, use any tool to enable features or functionalities that are otherwise disabled in the Software, or decompile, disassemble, or otherwise reverse engineer the Software except as otherwise permitted by applicable law; (vi) perform or attempt to perform any actions that would interfere with the proper working of the Software; or (vii) otherwise use the Software except as expressly allowed under the EULA. The Software is provided “As Is” without warranty of any kind. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, APOC AND SUPPLIERS SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OR FOR ANY DAMAGES RELATING TO LOSS OF BUSINESS, TELECOMMUNICATION FAILURES, THE LOSS, CORRUPTION OR THEFT OF DATA, VIRUSES, SPYWARE, LOSS OF PROFITS OR INVESTMENT, USE OF THE SOFTWARE WITH HARDWARE OR OTHER SOFTWARE THAT DOES NOT MEET APOC’S SYSTEMS REQUIREMENTS OR THE LIKE, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHERWISE, EVEN IF APOC AND/OR ITS SUPPLIERS, OR EITHER OF THEIR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND EVEN IF A REMEDY SET FORTH HEREIN IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW THE LIMITATION AND/OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. PLEASE READ THIS END USER LICENSE AGREEMENT (“EULA”) BEFORE USING THE DEVICE. USE OF THE DEVICE INDICATES END USER’S ACCEPTANCE OF THIS EULA. ACCEPTANCE OF THIS AGREEMENT IS A CONDITION TO THE RIGHTS GRANTED HEREIN. IF END USER DOES NOT AGREE WITH THE TERMS OF THIS EULA, END USER SHOULD NOT USE THE DEVICE. 1.
INTRODUCTION. Thank you for selecting the i-STAT® Analyzer (which includes certain software components (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
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2.
3.
4.
5. 6.
download from https://www.pointofcare.abbott/int/en/i-stat-alinity-support, tools and web-based components, together with all modifications, enhancements, updates or upgrades thereof (collectively, the“Software”). LICENSE GRANT AND RESTRICTIONS. Subject to the terms and conditions of this EULA, APOC grants you a personal, limited, non-exclusive, non-transferable, non-assignable license, during the Term (as defined in Section 4), to electronically access and use the Software, for the sole purpose of using the Device solely in accordance with the Systems Operations Manual (the “Manual”) . You are not licensed or permitted under this EULA to do any of the following and shall not allow any third party to do any of the following: (i) access or attempt to access any other APOC systems, programs or data that are not made available for public use; (ii) copy, reproduce, alter, merge, modify, adapt, translate, republish, upload, post, transmit, resell or distribute in any way the Software (or the Devices) or decompile, reverse engineer, disassemble, or otherwise reduce the Software to a human perceivable form; (iii) permit any third party to benefit from the use or functionality of the Software via a rental, lease, timesharing, service bureau, or other arrangement; (iv) transfer any of the rights granted to you under this EULA; (v) work around any technical limitations in the Software, use any tool to enable features or functionalities that are otherwise disabled in the Software, or decompile, disassemble, or otherwise reverse engineer the Software except as otherwise permitted by applicable law; (vi) perform or attempt to perform any actions that would interfere with the proper working of the Software; or (vii) otherwise use the Software except as expressly allowed under this Section 2. RESERVATION OF RIGHTS AND OWNERSHIP. The Software is licensed not sold, and APOC reserves all rights not expressly granted to you in this EULA. The Software is the proprietary and confidential property of APOC and its licensors and is protected by copyright, trade secret and other intellectual property laws. APOC and its licensors own the title, copyright, and other worldwide intellectual property rights in the Software and all copies of the Software. This EULA does not grant you any rights to trademarks or service marks of APOC. TERM AND TERMINATION. The Software is licensed during the time that the Devices are being used by End User, subject to compliance with the terms of this EULA and the Manual (the “Term”). This EULA shall terminate automatically if you fail to comply with any of its terms or conditions, including, without limitation, if you make any attempts to copy the Software, or transfer any copy of the Software or any portion thereof to another party or any attempt to modify the Software in any way. Upon termination you must immediately cease using the Software. Any termination of this EULA shall not affect APOC’s rights hereunder. PRIVACY. For details about our privacy policies, please refer to the Privacy Policy contained at www.pointofcare.abbott (“Privacy Policy”). You agree to be bound by the Privacy Policy, as it may be amended from time to time in accordance with its terms. DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED HEREIN, THE SOFTWARE, SERVICES, AND ANY CONTENT ACCESSIBLE THROUGH THE SOFTWARE ARE PROVIDED “AS-IS” AND, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, APOC, ITS AFFILIATES, LICENSORS, THIRD-PARTY CONTENT OR SERVICE PROVIDERS, DEALERS AND SUPPLIERS (IF ANY), (APOC, et al ARE COLLECTIVELY REFERRED TO HEREIN AS THE “SUPPLIERS”) DISCLAIM ALL GUARANTEES AND WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, REGARDING THE SOFTWARE, SERVICES, CONTENT, AND RELATED MATERIALS, INCLUDING ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, TITLE, MERCHANTABILITY, AND NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, APOC MAKES NO WARRANTY, AND PROVIDES NO ASSURANCE, THAT THE SOFTWARE WILL MEET CERTIFICATION REQUIREMENTS OF ANY REGULATORY AUTHORITY OR OTHER ASSOCIATION LICENSING AGENCY,
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WITHIN OR OUTSIDE OF THE UNITED STATES. APOC DOES NOT WARRANT THAT THE SOFTWARE IS SECURE OR FREE FROM BUGS, VIRUSES, INTERRUPTION, OR ERRORS, OR THAT THE SOFTWARE WILL MEET YOUR REQUIREMENTS. APOC DOES NOT WARRANT THAT THE USE OF THE SOFTWARE WILL BE UNINTERRUPTED OR ERROR FREE. SOME STATES DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSIONS MAY NOT APPLY TO YOU. IN THAT EVENT, ANY IMPLIED WARRANTIES ARE LIMITED IN DURATION TO 60 DAYS FROM THE DATE OF PURCHASE OR DELIVERY OF THE SOFTWARE, AS 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 YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE. 7. LIMITATION OF LIABILITY AND DAMAGES. THE ENTIRE CUMULATIVE LIABILITY OF APOC AND SUPPLIERS FOR ANY REASON ARISING FROM OR RELATING TO THIS EULA SHALL BE LIMITED TO FIVE HUNDRED DOLLARS OR THE AMOUNT PAID BY YOU FOR THE SOFTWARE, WHICHEVER IS LESS. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, APOC AND SUPPLIERS SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OR FOR ANY DAMAGES RELATING TO LOSS OF BUSINESS, TELECOMMUNICATION FAILURES, THE LOSS, CORRUPTION OR THEFT OF DATA, VIRUSES, SPYWARE, LOSS OF PROFITS OR INVESTMENT, USE OF THE SOFTWARE WITH HARDWARE OR OTHER SOFTWARE THAT DOES NOT MEET APOC’S SYSTEMS REQUIREMENTS OR THE LIKE, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHERWISE, EVEN IF APOC AND/OR ITS SUPPLIERS, OR EITHER OF THEIR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND EVEN IF A REMEDY SET FORTH HEREIN IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW THE LIMITATION AND/OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. 8. AUDIT. You agree that APOC may audit End User’s use of the Software for compliance with these terms at any time, upon reasonable notice. In the event that such audit reveals any use of the Software by You other than in full compliance with the terms of this EULA, End User shall reimburse APOC for all reasonable expense related to such audit in addition to any other liabilities End User may incur as a result of such non-compliance. 9. AMENDMENT. APOC shall have the right, to change or add to the terms of this EULA at any time upon notice by any means APOC determines in its discretion to be reasonable, including posting information concerning any such change, addition, deletion, discontinuance or conditions in Software or on any APOC sponsored web site. Any use of the Software by you after APOC’s publication of any such changes shall constitute your acceptance of this EULA as modified. 10. EXPORT LAW. The Software is subject to U.S. export control laws and may be subject to export or import regulations in other countries. Unless in compliance with applicable law and specifically authorized in writing by the APOC prior to any Software access, You shall not export the Software under any circumstances whatsoever. In any case, You will indemnify and hold the APOC harmless from any and all claims, losses, liabilities, damages, fines, penalties, costs and expenses (including reasonable attorney’s fees) arising from, or relating to, any breach by You of any of Your obligations under this section. 11. MISCELLANEOUS. Except as expressly set forth in this EULA, this EULA is a complete statement of the EULA between you and APOC and sets forth the entire liability of APOC and
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Suppliers, and your exclusive remedy with respect to the Software, and its use. Suppliers and their agents, employees, distributors, and dealers are not authorized to make modifications to this EULA, or to make any additional representations, commitments, or warranties binding on APOC. The waiver by either party of a breach of any provision of this Agreement or the failure by either party to exercise any right hereunder shall not operate or be construed as a waiver of any subsequent breach of that right or as a waiver of any other right. Any waiver of the terms herein by APOC must be in a writing signed by an authorized officer of APOC and expressly referencing the applicable provisions of this EULA. If any provisions of this EULA are determined to be invalid or unenforceable under applicable law, such provision shall be ineffective to the limited extent of such invalidity or unenforceability, without rendering invalid or unenforceable the remaining provisions of this EULA. If a court of competent jurisdiction declares any such provisions to be invalid or unenforceable, the parties hereto shall request that such court reduce the scope, delete specific words or phrases from the provision, or replace the provision with a provision that is valid and enforceable and that comes closest to expressing the original intention of the parties hereto, and this EULA shall be enforceable as so modified in the court in which the provision was declared invalid or unenforceable. This EULA will be governed by the laws of the state of Illinois as applied to agreements entered into and to be performed entirely within Illinois, without regard to its choice of law or conflicts of law principles that would require the application of law of a different jurisdiction, and applicable federal law. Neither this EULA nor any of Your rights or obligations hereunder may be assigned by You in whole or in part without the prior written approval of APOC. Any other attempted assignment shall be null and void. Headings are included for convenience only, and shall not be considered in interpreting this EULA. As used in this EULA, the word including means including but not limited to. This EULA does not limit any rights that 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.
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Regulatory compliance The i‑STAT Alinity system complies with applicable regulations.
Safety Regulations: USA
Conforms to UL Standard 61010-1: Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1: General Requirements and IEC Standard 61010-2-101
Canada
Certified to CSA Standard C22.2 No. 61010-1: Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1: General Requirements
European Union (EU)
IEC 61010-1: Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 1: General Requirements
European Union (EU)
IEC 61010-2-101: Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
European Union (EU)
IEC 62133: Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
International
UN Manual of Tests and Criteria “Recommendations on the Transport of Dangerous Goods,” Section 38.3 “Lithium Batteries”
International
IEC 60950-1: Information Technology Equipment–Safety–Part 1: General Requirements
EMC Regulations: USA
FCC 47 CFR Part 15, Subpart B, Class A (Unintentional Radiators)
Canada
CAN ICES-001 Class A, Industrial, Scientific and Medical Radio Frequency Radiators
European Union (EU)
IEC 61326-1: Electrical Equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements.
European Union (EU)
IEC 61326-2-6: Electrical Equipment for measurement, control and laboratory use – 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
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Aruba
Approved for use in accordance with article 4 of the Telecommunication Regulation. DTZ/910/2017/IZ, Pet nr. 3745
Australia
Complies with Australian Communications and Media Authority as required by the following Notices: • Radiocommunications (Compliance Labelling- Devices) Notice 2014 made under section 182 of the Radiocommunications Act 1992; • Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2008 made under section 182 of the Radiocommunications Act 1992; • Radiocommunications (Compliance Labelling- Electromagnetic Radiation) Notice 2014 made under section 182 of the Radiocommunications Act 1992; and • Telecommunications (Labelling Notice for Customer Equipment and Customer Cabling) Instrument 2015 made under section 407 of the Telecommunications Act 1997.
Bahamas
Utilities Regulation & Competition Authority (URCA) Type Approval UCRA_TA/2017_023 FCC ID: 2AAEX-SDABGN
Barbados
Complies with GOVERNMENT OF BARBADOS, TELECOMMUNICATIONS UNIT, Division of Energy & Telecommunications. MED Approval Number: 1905
Belize
Complies with Telecommunications Act, 2002 Type Approval per SI 152 OF 2002: PUC/APC/0182017/BZE
Bonaire - Sint Eustatius – Saba
Agentschap Telecom, Minisceñe van Economische Zaken Complies with articles 23 and 56 of the Besluit radio-elektrische inrichtingen BES and article 2 of the Regeling vrijstelling telecommunicatiemachtiging BES 2016 Type Approval 2017/008/AT and 2017/008a/AT
Botswana
Botswana Communications Regulatory Authority (BOCRA) Type Approval Certificate No: BOCRA/TA/2017/3642
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British Virgin Islands
Telecommunications Regulatory Commission Granted Equipment Type Approval for FCC Identifier 2AAEXSDABGN in accordance with section 42 of the Telecommunications Act 2006. Type Approval Number: VRGTA/011/2017
Brunei
AITI Authority for Info-communications Technology Industry of Brunei Darussalam Equipment Registration Certificate DRQ-D-BRUSIN-03-1998-7494LPD-39421
Burkina Faso
ARCEP Type Approval 2017-000031 Autorite de Regulation des Communications Electroniques et des Postes Authority of Regulations of Communications Electronic and Posts
Canada
Industry Canada RSS 210: Licence-Exempt Radio Apparatus: Category I Equipment Certification No.: 7228C-SDABGN
Cayman Islands
Utility Regulation and Competition Office GRANT OF EQUIPMENT AUTHORISATION IN THE CAYMAN ISLANDS Certificate. No: KY1504003
Colombia
Communications Regulatory Commission (CRC) - Exempt
Curacao
Director Bureau Telecommunicatie en Post Type Approval Nos. 2017/054/TA and 2017/054a/TA
Dominica
National Telecommunications Regulatory Commission (NTRC) Type Approval No. DMA-0217-0539p
Dominican Republic
Istituto Dominicano de las Telecomunicaciones (INDOTEL) Type Approval 17003658
Egypt
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European Union (EU)
DIRECTIVE 2014/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 EN 300 328: Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU.** EN 301 893: 5 GHz RLAN; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU.**
Grenada
National Telecommunications Regulatory Commission EQUIPMENT TYPE APPROVAL NTRC REGISTRATION NUMBER: CL 1090 | 17 – TA
Honduras
CONATEL Comision Nacional De Telecomunicaciones 20161024HM32
Hong Kong
CERTIFICATE OF TYPE APPROVAL per HKCA 1039 Issue 6, June 2015
India
Ministry of Communcations & IT Equipment Type Approval, ETA Certification No: ETA – 3319/16RLO(WR)
Israel
Ministry of Communications Type Approval Certificate No: 51-61266
Japan
Article 2 Section 1 No. 19, 19-3, 19-3-2 Radio Type Approval, Construction Designed Certificate No: 208-160178
Kuwait
CITRA Communication and Information Technology Regulatory Authority Type Approval Certificate
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Lebanon
Ministry of Telecommunications Approval 1031-16-041
Lesotho
Lesotho Communications Authority Lesotho Communications Authority Act 2012, Section 5
Libya
General Authority for Communications Type Approval Certificate No. 343-C1-2017
Madagascar
Autorite de Regulation des Technologies de Communication (ARTEC) No 17/026/ARTEC/DG/DHCT/SSS/test
Mauritius
Information & Communication Technologies Authority (ICTA) Type Approval Certificate Reference Number: TA/2017/0214
Mexico
Instituto Federal de Telecomunicaciones (IFT) Certificate No: RCPISAN18-1533 Certificado de Producto Nuevo de Conformidad con Norma Oficial Mexicana Certificate No: 1802CE09991
Morocco
Numéro d’agrément : MR 12797 Date d’agrément : ANRT 2016
Mozambique
Instituto Nacional das Comunicacoes de Mocambique (INCM) Telecommunication and Radiocommunications Agreements approved by Decree 37/2009 of 13 August No. 1/R/IMS/2017
New Zealand
Conforms to: Ministry of Business, Innovation & Employment, Radio Spectrum Management as required by notices under: • Section 134 (1) (g) of the New Zealand Radiocommunications Act 1989
Oman
Telecommunication Regulatory Authority, Approval Number: TRA/TA-R/4501/17
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Pakistan
Pakistan Telecommunication Authority (PTA), Type Approval Certificate TAC NO: 9.197/2017
Peru
Ministerio De Transportes Y Comunicaciones, Certificado De 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
Qatar
Communications Regulatory Authority Certificate of Type Approval CRA/SA/2016/R-5837
Saudi Arabia
Ministry of Communication and Information Technology (MCIT) Conformity Certificate TA 24012017-24012019-18944
Serbia
Confirmation of Conformity – R&TTE Number P1617182700
Singapore
Info-communications Media Development Authority Regulation 20(6) of the Telecommunications (Dealers) Regulations (Cap 323, Rg 6) Registration Number: N0123-17 (5 GHz) Registration Number: N0074-17 (2.4 GHz)
Sri Lanka
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St. Lucia
National Telecommunications Regulatory Commission (Saint Lucia) 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
St. Vincent & the Grenadines
National Telecommunications Regulatory Commission Telecommunications (Terminal Equipment and Public Networks) Regulations, No. 13 of 2002 Certificate of Type Approval, Certificate No.: SVG_050520171055
Turks and Caicos
Turks and Caicos Islands Telecommunication Commission Approval Certification under TCITC Ordinance PART V
United Arab Emirates
Telecommunications Regulatory Authority Telecom Equipment Registration Certificate ER53962/17 under Law No.3 of 2003
Uganda
Uganda Communications Commission Type Approved
USA
FCC 47 CFR Part 15, Subpart C - Intentional Radiators FCC 47 CFR Part 15, Subpart E - Unlicensed National Information Infrastructure Devices FCC ID: 2AAEX-SDABGN
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Vietnam
Ministry of Information and Communications Type Approval Certificate No: C0031280217AE01A2
Zambia
Zambia Information and Communications Technology Authority (ZICTA) Certificate of Type Approval ZMB/ZICTA/TA/2017/4/18 per ICT Act No. 15 of 2009
Zimbabwe
Postal & Telecommunications Regulatory Authority of Zimbabwe (POTRAZ) Certificate of Type Approval No POZ521
SAR / RF Exposure Regulations: USA
FCC 47 CFR Part 2 Subpart J - Equipment Authorization Procedures, Section 2.1093, Radiofrequency Radiation Exposure Evaluation: Portable Devices. FCC OET-65C: Evaluating Compliance with FCC Guidelines for Human Exposure to Radiofrequency Electromagnetic Fields
Canada
Industry Canada RSS 102 Radio Standards Specification 102, Radio Frequency (RF) Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands)
European Union (EU)
EN 50360: Product standard to demonstrate the compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields (Frequency range of 300 MHz - 3 GHz) EN 62209-1: Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from handheld and body-mounted wireless communication devices - Part 1: Devices used next to the ear (Frequency range of 300 MHz to 6 GHz) EN 62209-2: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (Frequency range of 30 MHz to 6 GHz)
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Environmental Regulations: European Union (EU)
RoHS Directive 2011/65/EU
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) This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the Federal Communications Commission (FCC) Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the operator’s manual, can cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case you will be required to correct the interference, at your own expense. Changes or modifications not expressly approved by the manufacturer could void your authority to operate the equipment.
Canadian Department of Communications Industry Canada Notice (Canada only) This Class A digital apparatus complies with Canadian ICES-001.
FCC Part 15 / Industry Canada Information: This device complies with Part 15 Subpart C and Subpart E of FCC Rules and Industry Canada licenceexempt RSS-210 standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference, including interference that may cause undesired operation of this device. This product contains transmitter module: FCC ID: 2AAEX-SDABGN IC: 7228C-SDABGN
SAR / RF Exposure Notice: This equipment complies with FCC/IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET-65 and RSS-102 of the IC (Industry Canada) radio frequency (RF) Exposure rules. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio
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interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. This radio transmitter (identify the device by certification number, or model number if Category II) has been approved by Industry Canada to operate with the antenna types listed below with the maximum permissible gain and required antenna impedance for each antenna type indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device. 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. 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.
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Symbols Table 1: Instrument/Power related Symbol
Definition/Use Keep away from sunlight. Model number. The model number will appear adjacent to this symbol. Printer Humidity limitation On/Off Direct current power supply Alternating current power supply For prescription use only. Battery status - fully charged Battery status - approximately ½ charged Battery status - charge needed soon Battery status - charge immediately Battery actively charging
Indicates battery actively charging
Software update is available.
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Table 2: Alert Icons Symbol
Definition/Use Pass Fail Warning Instrument locked Information Low battery
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
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Table 5: Cartridge related Symbol
Definition/Use 14 days room temperature storage at 18-30oC 2 months room temperature storage at 18-30oC Use by or expiration date. An expiration date expressed as YYYY-MM-DD means the last day the product can be used. An expiration date expressed as YYYY-MM means the product cannot be used past the last day of the month specified. Manufacturer's lot number or batch code. The lot number or batch will appear adjacent to this symbol. Sufficient for <n> tests
Table 6: Regulatory and Safety Related; Miscellaneous Symbol
Definition/Use Authorized representative for Regulatory Affairs in the European Community. Biological risks Temperature limitations. The upper and lower limits for storage are adjacent to upper and lower arms. Serial number. The serial number will appear adjacent to this symbol. Catalog number, list number, or reference USB Do not reuse. Date of manufacture Manufacturer Consult instructions for use or see System Manual for instructions.
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Symbol
Definition/Use Note the following information. In vitro diagnostic medical device Compliance to the European directive on in vitro diagnostic devices (98/79/EC) ETL product safety listing mark for U.S. and Canada
Electrical hazard Attention: See instructions for use. CAUTION: Indicates a hazardous situation, which if not avoided, could result in minor or moderate injury or damage to the equipment. WARNING: Indicates a hazardous situation, which if not avoided, could result in serious injury or death. Separate waste collection for this electrical/electronic item indicated; Equipment manufactured / put on the market after 13 August 2005; Indicates compliance with Article 10(3) of Directive 2002/96/EC (WEEE) for the European Union (EU). Table 7: Control related Symbol
Definition/Use Control
Table 8: For use on i‑STAT Value Assignment Sheets Symbol
Definition/Use Mean
R
Range
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Table 9: Analytes Symbol
Test
ACT
Activated Clotting Time
ACT-K
Kaolin activator
Na
Sodium
K
Potassium
Cl
Chloride
Glu
Glucose
Lac
Lactate
Crea
Creatinine
pH
pH
PCO2
Partial pressure of carbon dioxide.
PO2
Partial pressure of oxygen.
iCa
Ionized Calcium
BUN/UREA
Urea nitrogen/Urea
Hct
Hematocrit
Hb
Hemoglobin
TCO2
Total carbon dioxide concentration.
HCO3
Bicarbonate
BE (b&ecf)
Base excess (b for blood, ecf for extra cellular fluid)
AnGap
Anion Gap
sO2
Oxygen saturation
eGFR
Estimated Glomerular Filtration Rate
eGFR-a
Black/African-American Estimated Glomerular Filtration Rate
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Definitions and Terminology This section defines many of the terms and acronyms used in this guide.
Term or Acronym
Definition
Action Range
Results within the range that require immediate attention; also known as critical range.
Action Range Comment
Customized comment list or free text box displayed when results are in the action range.
ADT
Admit-Discharge-Transfer ADT messages contain patient demographic information.
Analyte
Substance or chemical constituent that is measured during the testing cycle. Analytes are listed on the cartridge pouch. Not all analytes are measured--some are calculated using the measured results of other analytes.
Analyte Settings
Group of features used to define the behavior of an instrument. Selections made in this setting group are considered basic and common to most instruments within a healthcare organization. It is also possible to make selections that are applicable to an entire healthcare organization. This is one of five categories that is required to build a profile.
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 instrument.
BSSID
Basic Service Set Identifier
CA
Certificate Authority
Cartridge Lot Number List
Cartridge lot number list managed within the customer's data management program for i-STAT Alinity
Cartridge Type
Name used to identify a cartridge, for example, CHEM8+, G3+, etc.
Categories
Features to define the behavior of an i‑STAT Alinity instrument. Manage and Assemble Profiles section of AlinIQ CWi has ten categories, five required categories and five optional categories. A collection of categories creates a profile for the i‑STAT Alinity.
CCMP
Counter Mode with Cipher Block Chaining Message Authentication Code Protocol wireless authentication type
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Term or Acronym
Definition
Change (edit)
To make different. Only unassigned categories or profiles may be changed.
Charge Station
Component of the i‑STAT Alinity system whose primary function is to charge the rechargeable battery. The Charge Station has a USB port for charging other devices.
CLEW
Standardization software
Cloud
Abbott Managed Cloud
Collapse All
Compress the view of the hierarchy to display only the roots of each Profile or Category on the Summary.
Connectivity Map
Programming data required to connect another system to the i‑STAT Alinity
Connectivity Settings
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.
CPB
Cardiopulmonary Bypass Surgery Setting. The CPB function adjusts hematocrit and hemoglobin results for the dilutional effect of pump fluid during cardiopulmonary bypass surgery.
Create from Existing
Using a previously created category or profile to create a new one.
CWi
Customization Workspace for i‑STAT
Data Entry
To enter data using the keypad or by scanning
Delivery System
Method used to deliver oxygen to a patient
DHCP
Dynamic Host Configuration Protocol
Discard
To delete settings prior to publishing
DNS
Domain Name System
Draft
Unfinished settings that can be saved and completed later
EAP
Extensible Authentication Protocol wireless authentication type
eVAS
Electronic Value Assignment Sheet
Expand All
Extension of the view of the hierarchy to display details of the profile or category on the summary.
Features
Options or settings that control the behavior of the i‑STAT Alinity instrument
Finish Later
Save the settings defined as a Draft
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Term or Acronym
Definition
General Settings
Group of features used to define the behavior of an instrument. Selections made in this setting group are basic and common to most instruments within a healthcare organization. It is also possible to make selections that are applicable to an entire healthcare organization. This is one of five categories that is required to build a profile.
HCO
Healthcare Organization
HIS
Hospital Information System
HTTP
Hypertext Transfer Protocol
Instrument
i‑STAT Alinity instrument
IP
Internet Protocol
IP Address
Internet Protocol Address. Identifier for a computer or device
K2EDTA or K3EDTA Setting
Anticoagulant used by the manufacturer of the Laboratory Hematology Instrument to calibrate. For best agreement of i‑STAT and hematology analyzer hematocrit results, the i‑STAT customization setting is selected according to the calibration of the comparative hematology analyzer (MH-K2EDTA or MH-K3EDTA). Note: This setting is not determined by the purple top tube used for patient testing in the laboratory.
LIS
Laboratory Information System
MAC
Media Access Control
Manage Items
Items get responses. An item is an on-screen prompt that requires a response by the operator. Items are grouped together in sets. Sets are assigned to a cartridge type (for example, EG7+, CHEM8+). When cartridge testing is performed, the defined set of items will be displayed, prompting the operator to enter the information.
Manage Sets
Sets are collections of items grouped together and assigned to cartridge types (for example, EG7+, CHEM8+). When a cartridge type is tested, the defined set of items will be displayed, prompting the operator to enter the information.
Mode
Ventilator mode for delivery of oxygen
MSCHAPv2
Microsoft Challenge Handshake Authentication Protocol, Version 2
NC
Network Configuration
Network Port
Part of the system connection that uses a Network Port number to send or receive service request from a client
Observations
Connectivity mapping for test records. Area for entering IP address and network port for the POC data manager.
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Term or Acronym
Definition
Operator List
List of certified operators. Cannot be enabled unless a POC data management system or any other system that certifies operators and sets operator permissions is being used.
Operator Settings
Group of features used to define the behavior of an instrument. Selections made in this setting group are considered basic and common to most instruments within a healthcare organization. It is also possible to make selections that are applicable to an entire healthcare organization. This is one of five categories that is required to build a profile.
Patient List
List of registered patients in a healthcare organization. Cannot be enabled unless an Admissions, Discharges, and Transfers (ADT) feed is being used.
Patient Settings
Group of features used to define the behavior of an instrument. Selections made in this setting group are considered basic and common to most instruments within an HCO. It is also possible to make selections that are applicable to an entire HCO. This is one of five categories that is required to build a profile.
Patient Temperature
Patient's temperature during the time of testing. The temperature entered here will be used to calculate patient temperature-adjusted blood gas results.
PEAPv0
Protected Extensible Authentication Protocol, Version 0
PPID
Positive Patient Identification
Profile
There are five required categories: General, Patient, Operator, Analyte and Quality Settings. The remaining five are optional. Profiles are assigned to an instrument through USB. See instructions in the Manage and Assemble Profiles section of this document.
PSK
Pre-Shared Key wireless authentication type
Publish
To make available for use after settings are defined
QC
Quality Control
QC Auto Fail Comment
Option to prompt an operator to enter a comment when QC results are out of range when using QC pass/fail using eVAS
QCC
Quality Check Code
Quality Settings
Group of features used to define the behavior of an instrument. Consider basing quality settings on the number of instruments in a department requiring QC at the same time. Department specific quality control plans may be defined using 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.
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Term or Acronym
Definition
Repeat Test
Option to prompt an operator to repeat a test
Result Notes
Prompts displayed on the screen after results are displayed. Designed to be used if post-analytical actions or comments are needed. They can be mandatory or optional. The notes will be transmitted along with the results to the data manager.
ReVAS
Electronic Value Assignment Sheet for customers in Germany.
Reviewer Name
Healthcare organization-designated connectivity manager for the defined vendor. Found in the Connectivity Settings category. This is a required response.
Sample Type
Blood sample type. Venous, arterial and capillary are currently supported by the i‑STAT Alinity System.
Selection List or Text Box
User-created list of responses.
SN
Serial Number
SSID
Service Set Identifier
STATNotes
Prompts displayed on the screen during the test cycle. Designed to provide information about the patient's status at the time of testing. STATNotes are used primarily, though not exclusively, for the recording of ventilator parameters. They can be mandatory or optional. The STATNotes will be transmitted along with the results to the data manager.
Summary
Display of all details within a Profile or Category
TKIP
Temporal Key Integrity Protocol wireless network authentication type
TLS
Transport Layer Security
Training Settings
Group of settings used to create the screens that display during a training event.
TTLS
Tunneled Transport Layer Security
UDP
User Datagram Protocol
Units
Standard of measurement for an analyte
USB
Universal Serial Bus
User Defined Message
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.
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Term or Acronym
Definition
User Role-Healthcare Organization Manager-Primary
User with permissions to access all functions of the CWi during the initial setup and creation of other CWi users. Healthcare 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. Changing this role requires contacting Abbott Point of Care technical support.
User Role-Healthcare Organization Manager
User who has the permission to access all functions of the CWi, but is limited to creating user roles of Point of Care Coordinator or Point of Care Super User.
User Role-POCC
User who has the permission to access all functions of the CWi, but is limited to creating user role of Point of Care Super User.
User Role-Point of Care Super User
User with view-only permission for functions of the CWi.
Vendor Name
Name of the provider that supplies the information in the connectivity map. For example, RALs, ConWorx, Cerner. It is a required field.
View
To look at an existing setting, in read-only format
WPA
Wi-Fi Protected Access wireless network authentication type
WPA2
Wi-Fi Protected Access II wireless network authentication type
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1.1 - Complete i‑STAT Alinity System Overview The i‑STAT Alinity instrument is an analytical, in vitro diagnostic device. The instrument requires i‑STAT single-use cartridges containing electrodes and sensors to perform quantitative diagnostic testing on whole blood. Together, the instrument and cartridge allow the user to perform clinical testing and related administrative tasks. The i‑STAT Alinity design enables the instrument to be taken to the patient’s bedside (point of care) or a convenient location near the point of care. After the insertion of a filled test cartridge, the instrument carefully monitors and controls the testing process. The only user intervention is in the form of data entry, performed via the touchscreen or by barcode capture. Throughout the cycle, the instrument performs a series of quality checks. These checks are designed to monitor the status of the instrument and the quality of the cartridge. An i‑STAT Alinity instrument, a cartridge with the required test, and two or three drops of blood will allow the caregiver to view quantitative test results within minutes. For the purposes of this system operations manual, the i‑STAT Alinity system components and associated accessories will be discussed. Additional information related to the entire system can be found in the i‑STAT Alinity system documentation listed below. Note: Where unavailability of results while awaiting replacement instruments or cartridges is unacceptable, Abbott Point of Care Inc. recommends maintaining both a backup i‑STAT Alinity instrument and cartridges from an alternate lot number.
i‑STAT Alinity Documentation: • i‑STAT Alinity System Operations Manual, including: ￮ i‑STAT Alinity Reference ￮ i‑STAT Cartridge and Test Information Sheets ￮ AlinIQ NCi - Network Connectivity for i‑STAT Alinity ￮ AlinIQ CWi - Customization Workspace for i‑STAT Alinity • i‑STAT Alinity Quick Reference Guide • i‑STAT Alinity Getting Started Guides: ￮ i‑STAT Alinity Instrument ￮ i‑STAT Alinity Base Station ￮ i‑STAT Alinity Rechargeable Battery ￮ i‑STAT Alinity Electronic Simulator ￮ i‑STAT Alinity Printer ￮ i‑STAT Alinity Charge Station
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i‑STAT Alinity system: • • • • • •
i‑STAT Alinity Instrument i‑STAT Alinity Base Station i‑STAT Alinity Rechargeable Battery i‑STAT cartridge i‑STAT Alinity Printer AlinIQ NCi
• • • • • • •
i‑STAT Alinity Electronic Simulator i‑STAT Controls solutions i‑STAT TriControls Control solutions i‑STAT Calibration Verification solutions i‑STAT TriControls Calibration Verification solutions AlinIQ CWi i‑STAT Alinity Charge Station
Note: Not all cartridges are available in all regions. Check with your local representative for availability in specific markets. Note that the component representations shown in the table are not drawn to scale. i‑STAT Alinity System Components i‑STAT Alinity Instrument Portable, ergonomically designed handheld analytical instrument used to perform in vitro diagnostic testing with the use of i‑STAT cartridges.
Base Station Provides recharging, printing, and network connectivity capabilities to the instrument.
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i‑STAT Alinity System Components Rechargeable Battery This Lithium-Ion rechargeable single cell battery is the primary source of power for the instrument. Power levels and charging status are indicated on the screen of the instrument.
Cartridges i‑STAT cartridges contain test reagents which are located on sensors on the top of the cartridge. The instrument and cartridge work together to generate a clinically meaningful result. Printer Provides the ability to print all results (patient tests, quality control, etc.) generated by the i‑STAT 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.
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i‑STAT Alinity System Components Charge Station Provides the ability to charge the rechargeable battery. USB port can be used to charge other devices.
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1.2 - i-STAT Alinity Instrument Intended Use The i‑STAT Alinity instrument with i‑STAT cartridges is intended for use in point of care or clinical laboratory settings. The i‑STAT Alinity system is intended for the quantitative measurement of various analytes in arterial, venous and capillary whole blood. For in vitro diagnostic use. Note: Not all cartridges are available in all regions. Check with your local representative for availability in specific markets. Verify the instrument for cartridge testing Note: Verification is only required once per cartridge type per instrument. Prior to using an instrument requiring a specific cartridge type, verify the instrument supports the cartridge: 1. Initiate a liquid quality control test per the instructions in Liquid Quality Controls of the System Operations Manual. 2. Ensure the instrument can successfully scan the cartridge pouch barcode. 3. If the cartridge is not recognized, contact your local representative.
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Principles of Operation The i‑STAT Alinity instrument is an analytical, in vitro diagnostic device. The design enables it to be taken to the patient’s bedside (point of care) or a convenient location near the point of care. The instrument requires i‑STAT single-use cartridges containing sensors to perform quantitative diagnostic testing on whole blood. After the insertion of a filled test cartridge, the instrument carefully monitors and controls the testing process. The only user intervention is in the form of data entry. Data entry is performed via the touchscreen or by barcode capture. Throughout the cycle, the instrument performs a series of quality checks. These checks are designed to monitor the status of the instrument and the quality of the cartridge. The instrument and cartridge together allow the user to perform clinical testing and administrative tasks related to in vitro quantification of various analytes in a whole blood sample. The i‑STAT Alinity instrument includes the following subsystems: • analytical measurement module: interfaces with the i‑STAT single-use test cartridges and controls execution of the measurement test cycle • user module: a central computing unit with embedded firmware that controls the user interaction with the device and supports communication with outside peripherals • user interface: allows data input, display of information, audio and visual alerts • rechargeable battery
Analytical Measurement Module The core measurement technology of the i‑STAT Alinity system is in the micro-fabricated electrochemical sensors located in the i‑STAT single-use disposable cartridges. As a result, the measurement technology used by the instrument and the principles governing operations associated with the generation of test results remain unchanged from the existing on-market i‑STAT instruments. These fully automated dedicated microprocessor controlled operations include: • Motion control of the fluid via mechanical actuators • Thermal control of the sensors during the test cycle • Acquisition of sensor electrical signals (voltage, current or resistance) throughout the test cycle, as well as environmental parameters like temperature and pressure • Timing and sequence of measurement events • Signal processing and conversion of sensor and environmental signals into analytical test results • Instrument self-tests and cartridge quality checks to prevent the delivery of an incorrect result in case of an instrument malfunction or if a cartridge or pre-analytical error is detected
User Module The i‑STAT Alinity instrument is equipped with a dedicated microprocessor to control user interaction with the device, synchronization of the test cycle with the user interface, and communication. The combination of the hardware microprocessor with peripherals and RTOS (Real Time Operating System) offer essential features for control of the instrument. Operations controlled by the combination of the microprocessor and RTOS include: • 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:
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￮ module allows convenient data entry in linear as well as 2D barcode symbology ￮ image based barcode scanner does not require precise orientation alignment of the target and the instrument, making scanning much more user friendly ￮ image of the barcode is displayed on the LCD screen during the scanning operation to further aid the user and to make scanning easier
User Interface i‑STAT Alinity is designed to maximize the user experience. The design of the user interface was guided by Human Factors Engineering principles. Both the size and resolution of the display have been increased to improve readability. The instrument employs a five inch diagonal backlit LCD in landscape orientation. The keypad was implemented with a resistive touchscreen, enabling a user wearing multilayer surgical gloves to perform data entry. A full QWERTY and numeric touchscreen keyboard enhances the informational content that can be entered and stored with a test. i‑STAT Alinity is equipped with a 1D/2D barcode scanner. i‑STAT Alinity features several connectivity options. The instrument contains dual band (2.4GHz, 5GHz) 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.
Rechargeable Battery The i‑STAT Alinity instrument is powered by a Lithium-Ion rechargeable battery pack which includes the battery cell as well as the charging and fuel gauge electronics. The rechargeable battery pack is directly attached to the bottom of the instrument. The battery pack and Base Station design allows the battery to be charged without detaching it from the instrument. The fuel gauge in the battery pack accurately measures the battery capacity while also providing protection against short circuit, over-current and overvoltage.
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More Options This section describes the selections and information found behind the More Options button.
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From the Home Screen touch More Options and this screen displays:
Note: • A button that is greyed out (light blue button with grey text) indicates that it is either inactive or has no data behind it. • Data Management system controls permission levels of operators. Many of the selections below will be protected if permission levels are set. If they are not, all selections will be open to all operators. In this case, facility policy should outline what users are allowed to access what functions under More Options. The next section of this document will describe the buttons and options for each. Breadcrumb trail on the instrument screen will help with navigation. Review Results • Last Result ￮ Displays data from the last test performed, cartridge or electronic simulator. • Patient Result ￮ Review results based on the following selections: ‒ All Patient Results ‒ Patient Results by ID ‒ Rejected Patient Results • Instrument must be customized to allow for rejection of cartridge results. • Quality Results ￮ Review results based on the following selections: ‒ Quality Control Results ‒ Cal/Ver Results ‒ Simulator Results ‒ Proficiency Results ‒ Quality Check Code Results ‒ Star-Out Results
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• Canceled Results ￮ Instrument must be customized to allow for the cancelling of a test. • All Results ￮ Display of all results on instrument regardless of testing pathway. Transmit Unsent Results • Force the transmission of all results in the instrument. Instrument must be customized to transmit results via wired or wireless transmission. Enable/Disable Wireless • Enabled ￮ Instrument must be configured for wireless transmission by using the 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. View Action Ranges and Analyte Info: An individual button is displayed for each analyte available for the i‑STAT Alinity system. Those buttons greyed out require activation via a customization profile or are not available at this time. Shown with the analyte is the unit of measure. Units of measure maybe modified via a customization profile or on the instrument via More Options > Instrument Options > Instrument Settings > Set Units Touching an active analyte button displays a second page of information: • Measurement range - Default is displayed unless a new range is set via a customization profile. • Critical Test - Default of no will be displayed unless modified via a customization profile. Touching the View Reference Range button will reveal the ranges set for this analyte via a customization profile. Note: No ranges are the default. Touching View Action (Critical) Ranges will reveal the ranges set for this analyte via a customization profile. Note: No ranges are the default. Instrument Status: • Important information such as firmware version, barometric pressure and profile name are listed here. Quality Options: • Quality Control ￮ Perform Unscheduled QC - when liquid QC testing is not scheduled via a customization profile or if an additional liquid QC testing event is desired, this is the testing pathway. Follow the prompts on the screen to perform testing. ￮ Scheduled QC - If liquid QC testing has been set via a customization profile, this is the testing pathway. Follow the prompts on the screen to perform testing. ￮ Perform Cartridge QC - This feature allows liquid control testing to release cartridges, based on lot number, for patient or proficiency testing. This method of QC testing must be set up via a customization profile as well as activation in the data management system.
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• Perform Electronic Simulator Test - Follow the prompts to perform testing. • Cal Ver ￮ Perform Unscheduled Cal Ver - When calibration verification testing is not scheduled via a customization profile or if an additional cal/ver testing event is desired, this is the testing pathway. Follow the prompts on the screen to perform testing ￮ Scheduled Cal Ver - If calibration verification testing has been set via a customization profile, this is the testing pathway. Follow the prompts on the screen to perform testing. • Perform Proficiency Test - Follow the prompts on the screen to perform testing. • Update eVAS ￮ Install from USB - Follow prompts on the screen to install instrument software. Note: Some preformatted USB flash drives may not work with the Alinity system. To avoid issues, reformat the drive using a Windows PC before using the USB flash drive with the Alinity system. ‒ If the instrument does not detect the base station, try the following: • remove the instrument and re-seat it on the Base Station • check to ensure that 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 • ensure that the USB is formatted • install from Cloud Services • View Disabled Cartridges - Cartridges are disabled due to expired QC. Administrative Options: • Operator Management ￮ Enable/Disable Training Mode - Enabling allows for operator to enter instrument training mode. Testing pathway screens in training mode are the same as those found in normal operation except for the purple frame around each screen. Although customization is not required for training mode use, there are many additional functions that can be added through customization. ￮ View Observation Checklist - This function requires creating a customization profile that includes a facility specific list of observable skills. Trainer may use the list to observe a trainee complete listed skills ￮ Operator Event Log - list of events stored in the instrument • Profile Management ￮ Install Profile from USB - Follow prompts on the screen to install instrument software. ‒ If the instrument does not detect the Base Station, try the following: • remove the instrument and re-seat it on the Base Station • check to ensure that 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. ￮ Refresh Profile - Instrument will retrieve assigned profile from the Cloud. ￮ 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. • Test Record Management
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Rev. Date: 26-Apr-2019
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￮ Review Test Record - Functions as a review results ‒ Last Result ‒ Patient Results ‒ Quality Results ‒ Canceled Results ‒ All results ￮ Review Training Records - View tests performed while in the training mode. ￮ Transmit Records - Select the range of records to be transmitted. ￮ Delete Records - Select the range of records to be deleted. ￮ Test Record Status - List of information regarding test records stored on instrument. • List Management ￮ Update All Lists - Function used to update patient, operator and cartridge lot list. A customization profile enabling lists must be in use on the instrument. ￮ Delete Lists - 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. Instrument Options: • Synchronize All - Initiate communications with data management system and Abbott Managed Cloud to synchronize lists (operator, patient, cartridge) and eVAS/ReVAS(Germany only) that are enabled on the instrument. • Software Installation ￮ Install from USB - Follow prompts on the screen to install instrument software. ‒ If the instrument does not detect the Base Station, try the following: • remove the instrument and re-seat it on the Base Station • check to ensure that 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 (as display message indicates). ￮ Install Pending - Instruct instrument to install software update. ￮ Check for Update - When Abbott Managed Cloud connectivity is set up on the instrument, touching this button causes the instrument to check for new software. If a new version of software is available, the update will automatically start downloading onto the instrument. See Software Updates section of this manual for complete details for downloading and installing software via the Abbott Managed Cloud. ￮ Software Status - List of information associated with software and eVAS. • Instrument Settings - Follow prompts on screen to: ￮ Set Language Note: When choosing a language that includes diacritical marks in its alphabet, the keypad's appearance will change. See the section Keypad changes for languages using diacritical marks for details. ￮ Set Clock ￮ Set Units ￮ Set Date Format • Network Settings
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￮ Install Network Settings - Follow prompts on screen to install network settings from a USB stick. The NCi utility is used to create the ancc file that will be installed via the USB stick. Note: Some preformatted USB flash drives may not work with the Alinity system. To avoid issues, reformat the drive using a Windows PC before using the USB flash drive with the Alinity system.
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‒ If the instrument does not detect the Base Station, try the following: • remove the instrument and re-seat it on the Base Station • check to ensure that 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. Enable/Disable Cloud Services - This must be enabled in order to receive automatic Value Assignment Sheet (VAS) updates. Use of the NCi utility is required to make the connection between the instrument and the Abbott Managed Cloud Enable/Disable Wireless - This must be enabled in order for the instrument to have the ability to communicate wirelessly. Use of the NCi utility is required to make the connection between the instrument and the wireless. 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.
• Instrument Service ￮ Reset Instrument - Choose an option on the screen, by touching the text box indicating the action desired. Follow the prompts on the screen to complete the action. ￮ Export Logs - Follow prompts on screen to export instrument logs to a USB stick. ￮ View Running Applications - Software information – used primarily by technical support. ￮ Set Region Code - Touch this button and follow prompts on screen to complete the region code setup.
i-STAT Alinity — System Operations Manual
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Rev. Date: 26-Apr-2019
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Keypad changes for languages using diacritical marks Based on the language chosen during instrument setup (see Getting Started Guide for the i‑STAT Alinity instrument), the on screen keypad will display keys that have a small white dot in the upper right hand corner, as shown:
i-STAT Alinity — System Operations Manual
Art: 745527-01 Rev. G
Rev. Date: 26-Apr-2019