Operations Manual
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Table of Contents Foreword
vii
Regulatory compliance Symbols Definitions and Terminology
xiii xxv xxxi
i-STAT ALINITY INSTRUMENT - END USER LICENSE AGREEMENT...viii
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... 11 Calibration of the i-STAT Alinity instrument... 25 Specifications... 26 Wireless Labeling...26 Precautions and Limitations... 27 Messages and Troubleshooting ... 29 Quality Check Failure Codes... 29 Cleaning and Disinfecting... 41
1.3 - i-STAT Alinity Results Screen
43
Interpreting Results... 45
1.4 - i-STAT Alinity Rechargeable Battery
49
Principles of Operation...49 Specifications... 50 Precautions and Limitations... 50
1.5 - i-STAT Alinity Base Station
53
Specifications... 54 Precautions and Limitations... 55 Troubleshooting ... 56 Cleaning and Disinfecting... 56
1.6 - i-STAT Alinity Electronic Simulator
57
Principles of Operation...57 Specifications... 57 Precautions and Limitations... 58
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Cleaning and Disinfecting... 59
1.7 - Perform Electronic Simulator Testing
61
Perform the Thermal Probe Check... 63
1.8 - i-STAT Alinity Printer
65
Principles of Operation...66 Specifications... 67 Precautions and Limitations... 68 Troubleshooting... 69 Cleaning and Disinfecting... 71
1.9 - Manufacturer's Quality System Instructions
73
1.10 - Liquid Quality Controls
75
i-STAT Controls and i-STAT TriControls... 75 i-STAT ACT Controls... 79
1.11 - Calibration Verification (Cal Ver)
81
Calibration Verification testing and i-STAT TriControls Calibration Verification Solutions... 82
1.12 - i-STAT Cartridges
87
i-STAT Cartridge Components... 91 Receiving a New Shipment of Cartridges... 96 Precautions and Limitations... 96
1.13 - Software Updates
99
Software Update and Installation using USB memory device via Base Station... 99 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wired Network Connection... 103 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wireless Network Connection... 107
2 - AlinIQ Network Connectivity for i-STAT (NCi)... 111 2.1 - AlinIQ NCi - Network Connectivity for i‑STAT
113
AlinIQ NCi - General Section...115 AlinIQ NCi - Proxy Server Connection...117 AlinIQ NCi - Wireless Network Connection... 119 AlinIQ NCi - Wired Network Connection... 123 AlinIQ NCi - Save the Network Connectivity (ancc) file ... 125 AlinIQ NCi - Copy NC (ancc) file onto a USB memory stick...126 AlinIQ NCi - Upload an NC (ancc) file to an instrument...126
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AlinIQ NCi - Customization and Connectivity... 127 AlinIQ NCi - Determining Success or Failure...127
3 - AlinIQ Customization Workspace for i-STAT (CWi)...129 3.1 - AlinIQ CWi - Customization Workspace for i-STAT
131
Workspaces ... 131 Best Practices... 132 Getting Started ... 132 CWi - Home page... 136
3.2 - Manage Healthcare Organization
139
Overview - Healthcare Organization... 139 Best Practices... 140 Getting Started... 140
3.3 - Manage Users
141
Overview... 141 Best Practices... 141 Getting Started... 142
3.4 - Manage and Assemble Profiles
145
Best Practices... 146 Creating a Category... 147 *General Settings Category... 151 Basic Functions... 152 Date... 154 Communications...155 Operator Actions... 156 Critical Callback... 161 Print... 165 i-STAT Reserved... 166 Summary... 166 *Operator Settings Category... 167 List Actions... 171 Operator Expiration... 174 Summary... 174 *Patient Settings Category... 175 ID Entry... 176 Patient Information and Positive Patient Identification (PPID)...179 Summary... 180 *Analyte Settings Category... 181 Units... 182 Sample Types... 183 Ranges... 184 Enable/Disable Analyte... 187
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Hematocrit... 188 Adjustments... 190 ACT (Activated Clotting Time)...191 Critical Tests... 192 Summary... 192 *Quality Settings Category ... 193 Electronic Simulator... 194 QC Notifications ...195 Liquid QC (Quality Control) Schedules...200 Cal Ver Schedules... 203 Summary... 205 User Defined Message Category ... 206 Summary... 207 Training Settings Category... 207 Basic Functions... 208 Summary... 210 STATNotes Category... 211 Data Entry ... 213 Selection List ...217 Selection List with Text box... 219 Mode... 220 Delivery System... 224 Patient Temperature...227 Manage Sets... 228 Summary... 230 Result Notes Category... 231 Data Entry ... 232 Selection List...236 Selection List with Text box... 238 Repeat Test Item... 239 Action Range Comment...240 QC Auto Fail Comment... 241 Manage Sets... 242 Summary... 245 Connectivity Settings Category...246 Connectivity Map... 247 Summary... 248 Assemble a Profile ... 249 Install a Profile from a USB... 251
3.5 - AlinIQ CWi – Customization Workspace for i-STAT Troubleshooting 253
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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.
2.
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 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
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3.
4.
5.
6.
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, 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
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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 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
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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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Argentina
Republica Argentina – Poder Ejecutivo Nacional Type Approval C-22657
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
Bermuda
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
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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
British Virgin Islands
Telecommunications Regulatory Commission Granted Equipment Type Approval for FCC Identifier 2AAEX-SDABGN 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
China
Radio Transmission Equipment Type Approval CMIIT ID: 2019AJ8315
Colombia
Communications Regulatory Commission (CRC) - Exempt
Costa Rica
Superintendencia de Telecomunicaciones approval 04979-SUTELDGC-2017
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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
Ecuador
Agencia de Regulación y Control de las Telecomunicaciones approval ARCOTEL-CCDH-2018-0337-OF
Egypt
NTRA National Telecom Regulatory Authority
El Salvador
Superintendencia General de Elecricidad y Telecomunicaciones approval DBP-046-2017
Ethiopia
The Federal Democratic Republic of Ethiopia Minisitry of Innovation and Technology Type Approval 1263/2019
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)
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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
Jordan
The Hashemite Kingdom of Jordan Telecommunications Regulatory Commission Approval TRC/LPD/2017/555
Kuwait
CITRA Communication and Information Technology Regulatory Authority Type Approval Certificate
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
Maldives
Communications Authority of Maldives Type Approval CAMTAC2019-03
Mauritius
Information & Communication Technologies Authority (ICTA) Type Approval Certificate Reference Number: TA/2017/0214
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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
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
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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)
South Africa
Independent Communications Authority of South Africa Radio Equipment Type Approval TA-2018/3846
Sri Lanka
Telecommunications Regulatory Commission of Sri Lanka, TRC/SM/ MISC/00041/17/WIFI-106
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
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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
Uruguay
Unidad Reguladora de Servicios de Comunicaciones VU20181105-015044
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
Vietnam
Ministry of Information and Communications Type Approval Certificate No: C0031280217AE01A2
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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)
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)
i-STAT Alinity - System Operations Manual
Art: 746983-01 Rev. H
Rev. Date: 11-Nov-2020