Related Manuals for illumina MiSeqDx Instrument
Summary of Contents for illumina MiSeqDx Instrument
- Page 1 MiSeqDx Instrument Safety and Compliance Guide ILLUMINA PROPRIETARY Document # 15034477 v05 Nov 2021 FOR IN VITRO DIAGNOSTIC USE...
- Page 2 MiSeqDx Instrument Safety and Compliance Guide This document and its contents are proprietary to Illumina, Inc. and its affiliates ("Illumina"), and are intended solely for the contractual use of its customer in connection with the use of the product(s) described herein and for no other purpose.
- Page 3 MiSeqDx Instrument Safety and Compliance Guide Revision History Document # Date Description of Change 15034477 v05 November Added statement for indoor use only. Removed old R&TTE directive. 2021 Added EMC Considerations, FCC Compliance, and IC Compliance statements. Added compliance statements for Brazil, Korea, Thailand, Mexico, and United Arab Emirates.
- Page 4 MiSeqDx Instrument Safety and Compliance Guide Document # Date Description of Change 15034477 v02 January Updated the FCC EMC considerations regarding 2017 radio interference in a domestic environment. Added the following compliance directives: • RoHS 2011/65/EU • Radio Equipment Directive 2014/53/EU Updated the following compliance directives: •...
- Page 5 MiSeqDx Instrument Safety and Compliance Guide Document # Date Description of Change 15034477 v01 October Updated regulatory markings on the back cover. Added a revision history. 2015 Reordered sections of the guide into a Product Compliance and Regulatory Statements chapter.
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Page 6: Table Of Contents
MiSeqDx Instrument Safety and Compliance Guide Table of Contents Revision History Introduction Safety Considerations and Markings General Safety Warnings Electrical Safety Warnings Hot Surface Safety Warning Heavy Object Safety Warning Uncrating, Installing, and Moving the Instrument Environmental Constraints Symbols Product Compliance and Regulatory Statements... -
Page 7: Introduction
MiSeqDx Instrument Safety and Compliance Guide Introduction This guide provides important safety information pertaining to the installation, servicing, and operation of the MiSeqDx, as well as product compliance and regulatory statements. Read this document before performing any procedures on the MiSeqDx. -
Page 8: Safety Considerations And Markings
Safety Considerations and Markings The purpose of this section is to identify the potential hazards associated with installing, servicing, and operating the MiSeqDx instrument. Do not operate or interact with the instrument in a manner that exposes you to any of these dangers. -
Page 9: Electrical Safety Warnings
10 Amps for a 100–110V power source 6 Amps for a 220–240V power source • For more information, see the MiSeqDx Instrument Site Preparation Guide (document # 15070066). Protective Earth The instrument has a connection to protective earth through the enclosure. The safety ground on the power cord returns protective earth to a safe reference. -
Page 10: Hot Surface Safety Warning
The instrument weighs approximately 57 kg (126 lb) and can cause serious injury if dropped or mishandled. Uncrating, Installing, and Moving the Instrument Only Illumina-authorized personnel should uncrate, install, or move the MiSeqDx. If the instrument must be relocated, contact Illumina Customer Support to arrange a service visit. For contact information, see Technical Assistance. -
Page 11: Environmental Constraints
MiSeqDx Instrument Safety and Compliance Guide Environmental Constraints For indoor use only. Element Specification Temperature Transportation and Storage: -10°C to 40°C (14°F to 104°F) Operating Conditions: 19°C to 25°C (66°F to 77°F) Humidity Transportation and Storage: Non-condensing humidity Operating Conditions: 30–75% relative humidity (non-condensing) Elevation Locate the instrument at an altitude below 2000 meters (6500 feet). -
Page 12: Symbols
MiSeqDx Instrument Safety and Compliance Guide Symbols For in vitro diagnostic use European Representative Manufactured By Date of Manufacture Model Number Serial Number Humidity Range (on packaging: indicates acceptable shipping and storage limits) Temperature Range (on packaging: indicates acceptable shipping and... -
Page 13: Product Compliance And Regulatory Statements
MiSeqDx Instrument Safety and Compliance Guide Product Compliance and Regulatory Statements Product Certifications and Compliance Hereby Illumina declares that the MiSeqDx is in compliance with the following directives: • EMC 2014/30/EU • IVD 98/79/EC • Low Voltage 2014/35/EU • Radio Equipment 2014/53/EU RoHS 2011/65/EU and its amendments •... - Page 14 MiSeqDx Instrument Safety and Compliance Guide CAUTION Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. NOTE This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC rules.
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Page 15: Ic Compliance
MiSeqDx Instrument Safety and Compliance Guide IC Compliance This Class A digital apparatus meets all requirements of the Canadian Interference‐ Causing Equipment Regulations. This device complies with Industry Canada licence‐exempt RSS standards. Operation is subject to the following two conditions: This device may not cause interference. -
Page 16: Brazil Compliance
MiSeqDx Instrument Safety and Compliance Guide Le présent émetteur radio (IC ID: 9859A‐MISEQ) a été approuvé par Industrie Canada pour fonctionner avec les types dʹantenne énumérés ci‐dessous et ayant un gain admissible maximal et lʹimpédance requise pour chaque type dʹantenne. Les types dʹantenne non inclus dans cette liste, ou dont le gain est supérieur au gain maximal indiqué, sont strictement interdits pour lʹexploitation de lʹémetteur. -
Page 17: Technical Assistance
Technical Assistance For technical assistance, contact Illumina Technical Support. Website: www.illumina.com Email: techsupport@illumina.com Illumina Technical Support Telephone Numbers Region Toll Free International Australia +61 1800 775 688 Austria +43 800 006249 +43 1 9286540 Belgium +32 800 77 160 +32 3 400 29 73... - Page 18 +44 20 7305 7197 United States +1 800 809 4566 +1 858 202 4566 Vietnam +84 1206 5263 Safety data sheets (SDSs)—Available on the Illumina website at support.illumina.com/sds.html. Product documentation—Available for download from support.illumina.com. Document # 15034477 v05 FOR IN VITRO DIAGNOSTIC USE...
- Page 19 Nursing Association Building +1.858.202.4566 (outside North America) Level 3, 535 Elizabeth Street techsupport@illumina.com Melbourne, VIC 3000 Illumina Netherlands B.V. www.illumina.com Australia Steenoven 19 5626 DK Eindhoven The Netherlands FOR IN VITRO DIAGNOSTIC USE © 2021 Illumina, Inc. All rights reserved.