Gold Standard ThunderBolt - 1 Introduction; Intended Use; Certifications; 2 Safety Information

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1. Introduction
Thepurposeofthismanualis toidentifytheinstrumentcomponentsandprovideinstructionsforuseof
theThunderBolt.Thismanualprovidesbasicsafetyinformation,instructionsforuseandmaintenance,
as well as general troubleshooting guidance.It is recommended that this manual be kept near the
instrumentandaccessibletothe
useratalltimes.
Note: All references to CLIA (Chemilu minescent Immunoassay), luminescence, or RLU (Relative Light
Units) measurement are only available for use with ThunderBolt instruments equipped with the
chemiluminescenceoption.
1.1. IntendedUse
The ThunderBolt is designed to automate the processing of enzyme immunoassay (EIA) and
Chemiluminescent Immunoassay (CLIA)tests.The system is only intended to be used by properly
trainedpersonnel.
The intended use for the ThunderBolt is as a discrete photometric chemistry analyzer intended to
duplicatemanualanalyticalprocedures byperformingvarious
stepssuchaspipetting,heating,and
measuring color intensity automatically.The ThunderBolt is also  intended to perform as an
‘accessory’tobeusedwithadevicetoenablethatdevicetobeusedinaccordancewithitsintended
purpose.
1.2. Certifications
TheThunderBoltisregisteredandcertifiedashavingmetthefollowingregulatoryrequirements:
ISO13845:2003
ENISO13485:2012
DirectiveEN98/79/EC
EN61010‐1:2001
EN61010‐1:2001‐02
USandCAnationaldeviationsasshowninthetestreport586125.01
2. SafetyInformation
ThefollowingsafetyinstructionsaretobeobservedatalltimesduringtheoperationoftheThun derBolt.
It is strongly recommended that all first time personnel read this manual prior to working with the
instrumentandreceivetrainingfromGoldStandardDiagnostics(GSD)oraGSDdistributor.
TheThunderBoltisdesigned
andmanufacturedinaccordancewiththesafetyrequirementsforelectronic
andmedical systemslisted in thecertifications sectionabove to ensurethat theinstrumentfunctions
safely,bothelectricallyandmechanicallyundernormaluseconditions.TheThunderBoltissuppliedina
conditionthatallowsforsafeandreliableoperation.
2.1. GeneralSafety
The ThunderBolt must only be operated in accordance with the stated intended use.It is
recommendedthattheThunderBoltisusedonlywiththe sparepartsandaccessoriessuggestedor
providedbyGoldStandardDiagnostics.Theuseandmaintenanceactivities definedinthismanual
areintendedtoensurethe safetyof
theoperatorandtheproperfunctionalityoftheinstrument.All
system surfaces must be dry while operating the ThunderBolt.Gold S tandard Diagnostics