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cobas Liat SystemOperator’s ManualVersion 8.0 for use in the USSoftware Version 3.2VV-07723-01

COBAS, LIAT and LIFE NEEDS ANSWERS are trademarks of Roche. 2017-2018 RocheRoche Diagnostics9115 Hague RdP.O. Box 50457Indianapolis, IN che.com

iPublication informationEdition noticeThis publication is intended for operators of the cobas Liat System.The contents of this document, including all graphics andphotographs, are the property of Roche. No part of this documentmay be reproduced or transmitted in any form or by any means,electronic or mechanical, for any purpose, without the expresswritten permission of Roche.Every effort has been made to ensure that the information is correctat the time of publishing. Not all functionality described in thismanual may be available to all users. Roche Diagnostics reservesthe right to change this publication as necessary and without noticeas part of ongoing product development. Such changes may notimmediately be reflected in this document.ScreenshotsAny screenshots in this publication are added exclusively for thepurpose of illustration. Configurable and variable data such asparameters, results, path names etc. visible therein must not beused for laboratory purposes.Intended useThis document is intended for the US market only.Caution: Federal law restricts this device to sale by or on theorder of a physician.CopyrightTrademarks 2017-2018, Roche Diagnostics. All right reserved.The following trademarks are acknowledged.COBAS, LIAT and LIFE NEEDS ANSWERS are trademarks ofRoche.All other product names and trademarks are the property of theirrespective owners.FeedbackThis document was created by Roche Diagnostics GmbH(operator manual content) and the Roche Diagnostics EngineeringOperations department (US Supplement). Direct questions orconcerns regarding the contents of this document to:Roche Diagnostics CorporationEngineering Operations Department9115 Hague RoadP.O. Box 50457Indianapolis, IN 46250-0457USAThis document is available on the Roche Diagnostics USA websiteat t availabilityRoche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)

iiOS-00192-01Roche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)

US SupplementWarranty for the instrumentRoche warrants the instrument against defects in materials andworkmanship (except for consumable items and lamps) for aperiod of one year (90 days in the case of parts in direct contactwith reagents). Roche, at its option, either replaces or repairs free ofcharge, on an f.o.b. Indianapolis, Indiana basis, all instruments andparts which prove to be defective and are subject to such warranty.Field-installed options, modifications, and used equipment carrya ninety (90) day parts and labor warranty. Any componentpart(s) and labor necessary to complete a repair are guaranteed forthirty (30) days. Some replacement components, such as printers,monitors, etc., may carry a longer warranty.This warranty does not apply to instruments not installed by aRoche Field Service Representative/Field Application Specialist(or authorized agent of Roche) and/or not used according toinstructions or damaged by accident, alteration, misuse, tampering,and/or abuse.We warrant that the services provided under a Roche Warrantyor Service Agreement are free from defects in workmanship for aperiod of thirty (30) days from the date of service.Warranty for the reagentRoche warrants that this product will meet the specifications statedin the labeling when used in accordance with such labeling andwill be free from defects in material and workmanship until theexpiration date printed on the label.OS-00192-01WE HEREBY DISCLAIM ALL OTHER WARRANTIES, WHETHEREXPRESS OR IMPLIED, INCLUDING WARRANTIES OFMERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE,WITH RESPECT TO THE EQUIPMENT, REAGENTS AND SERVICESPROVIDED, EXCEPT THE LIMITED WARRANTY SET FORTHABOVE. WE ARE NOT LIABLE FOR ANY INCIDENTAL, INDIRECT,SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOTLIMITED TO, LOST PROFITS OR REVENUES, LOSS OF THE USE OFTHE CAPITAL, COST OF SUBSTITUTE EQUIPMENT, REAGENTS,FACILITIES OR SERVICES AND/OR DOWN-TIME COSTS RESULTINGFROM OR ARISING IN CONNECTION WITH THE PERFORMANCE,DELAY IN PERFORMANCE OR NONPERFORMANCE OF ANYTERM OR CONDITION OF A ROCHE WARRANTY OR SERVICEAGREEMENT OR FROM THE USE OR MISUSE OF THE INSTRUMENT(OR ANY SUBSTITUTE THEREFORE) OR REAGENTS OR ANYMATERIALS OR WORKMANSHIP DELIVERED HEREUNDER, EVENIF WE HAVE BEEN ADVISED, KNEW OR SHOULD HAVE KNOWN OFTHE POSSIBILITY OF SUCH DAMAGES. YOUR EXCLUSIVE REMEDYWITH RESPECT TO OUR WARRANTY OF ANY EQUIPMENT,REAGENTS OR PARTS SHALL BE REPAIR OR REPLACEMENT OFTHE DEFECTIVE ITEM(S), AT OUR OPTION. AS YOUR EXCLUSIVEREMEDY FOR ANY SERVICE PERFORMED UNDER THIS LIMITEDWARRANTY WE SHALL RE-PERFORM ANY SERVICE WHICH WASDEFECTIVE.Roche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)US - 1

US - 2US SupplementContact Support and/or Service RepresentativesRoche provides 24 hour-a-day, 365 day-a-year telephone assistance.In addition, on-site service is provided in a timely manner. Inorder for us to comply with federal record keeping requirements, ifyou need to contact your Roche Diagnostics service representative,call the appropriate Customer Support Center number listed below.They, in turn, notify your representative to contact you.cobas Liat System1-800-800-5973The Customer Support Center answers all calls pertaining toRoche products. If the Customer Support Center cannot resolve aproblem by phone, a Roche representative is dispatched.Service policy questionsQuestions relating to your service policy can be referred to yourlocal Roche representative or the regional service manager bycalling the appropriate Customer Support Center number.Customer TrainingRoche Diagnostics conducts Indianapolis-based operator trainingcourses and/or field-based training depending upon the instrumentor system you purchased. Please contact your Roche Diagnosticsrepresentative for course availability and scheduling.Ordering InformationOrder replacement parts, consumable materials, reagents,standards, calibrators and controls as necessary from Roche. Pleaseuse the catalog number and reference name for each item whenplacing an order with Roche Customer and Business SupportCenter.Roche Customer and Business Support Center number1-800-428-5030Contacting Sales RepresentativesIf you wish to contact your sales representative, he or she may bereached by calling Customer and Business Support Center or byleaving a message on their voice mail.Roche Customer and Business Support Center numberVoice mail1-800-428-50761-800-845-7355Entering the appropriate mailbox number or press # to spell thename.OS-00192-01Roche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)

US SupplementCustomer CommunicationsAs the need arises, you shall receive various customercommunications concerning information about your system. Theseupdates are usually in one of the following forms.Customer communications can also be viewed on the internet.Some documentation is available online only.Go to https://usdiagnostics.roche.com and select Documentation.BulletinsBulletins (Reagent, Software, or Analyzer) are printed on RocheDiagnostics letterhead. Bulletins contain information that is vitalto the performance of your system. Bulletin information shouldbe communicated internally to all analyzer operators. Bulletinsshould be kept on file until the reagent expires, you receive updatedlabeling or you are notified by Roche Diagnostics to discard them.Urgent Medical Device Correction or RemovalUrgent Medical Device Correction or Removal is printed on RocheDiagnostics letterhead with the words Urgent Medical DeviceCorrection or Urgent Medical Device Removal. These requireimmediate attention by the analyzer operator and are to be filed forreference until further notice.Customer LettersProduct AnnouncementCustomer Letters are printed on Roche letterhead and containgeneral information or attachments that you may place in yourfiles. You may discard Customer Letters after reading and followingany applicable instructions contained in them.Product Announcements are usually announcing productlaunches. They contain specific details about a new product suchas features and benefits, kit configuration and pricing. ProductAnnouncements may or may not be discarded depending on yourlaboratory’s preference.CLIA/CLSI ComplianceOS-00192-01Roche documentation, which includes this operator’s manual,methods sheets and active customer bulletins, conforms withthe guidelines in effect at the time of publication listed in theCode of Federal Regulations (CFR) and the Clinical LaboratoryStandards Institute (CLSI) General Laboratory Practices and SafetyGuidelines. Documentation also meets the Centers for Medicareand Medicaid Services, formerly known as Health Care FinancingAdministration, interpretation of the requirements for the ClinicalLaboratory Improvement Amendments (CLIA ‘88).Roche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)US - 3

US - 4US SupplementContacting Commercial EducationThe documentation you receive to operate your system, prepareand/or utilize reagents, is created by several departments withinRoche. The Commercial Education department produces most ofthe training documentation you receive here in Indianapolis, or atyour on-site training.To contact Commercial Education send an email to Indianapolis.TechPub@roche.comProvide your name and account number when contacting us. Wewill get back to you, or fill your request, as soon as possible.If you have any questions on documentation that is not of atraining nature, contact the appropriate Customer SupportCenter as designated in the Contact Support and/or ServiceRepresentative section.To Change Mailing Addresses or Contact NamesThere are several ways to change your mailing address or thecontact name for your account. You may send an email, leave amessage or go to https://usdiagnostics.roche.comPlease provide your name and account number when contacting us.Your account number is provided to you by a Roche representativewhen your analyzer is anapolis.marcom-tech pubs@roche.comContact Contact Change Form.OS-00192-01Roche DiagnosticsOperator’s Manual US SupplementVV-07723-01 (08416214001)

cobas Liat SystemOperator's ManualVersion 8.0Software version 3.2VV-07723-01

2VV-07723-01Roche Diagnosticscobas Liat System · Software version 3.2 · Operator's Manual · Version 8.0 P/N: 08416214001