Requirements for Instruction Manuals in the European Market Introduction with Samples

1. Requirements for Instruction Manualsin the European MarketIntroduction with Samples • The International Symposium • on Technical Communication andProduct Marketing • 25-27 May 2013, Guiyang City, Guizhou Province, China • Dr. Konstantin Angnostopoulos • ISE Europe GmbH, • Switzerland

2. Contents Part 1 - European Directivesand Standards Harmonizationof Laws and Standards in Europe EU-Directives and EN Standards for instruction manuals Productionprocessofinstructionmanuals SafetyandUsabilityaspects in instructionmanuals Part 2-Introductionofsamples Risk Assessment - definitionofsafetyinstructions ProductSpecificStandards -specificsafetyinstructions Country Deviations-countryspecificsafetyinstructions Usabilityandconsumertest - improvements on instructionmanualergonomics Part 3 - ISE EuropeGmbH, alliancenetworkandservices

3. Part 1 Harmonizationof Laws and Standards in Europe EU-DirectivesEU/EFTA assigns CEN thecreationof European Standards New Approach Consistent Laws Consistent, Harmonized Standards

4. EU-Directives and EN Standardsimportant for design of instruction manuals • EU Directives: • 2006/42/EC Safety of Machinery • 2006/95/EC Safety of Low Voltage Equipment • 2001/95/EC General Product Safety Directive • 2004/108/EC EMC Directive • 93/42/EECMedical Equipment Directive • EN Standards: • IEC 82079-1:2012 Preparation of instructions for use • EN 12100:2010 Safety of machinery - risk assessment and reduction • EN 9241:2006 Ergonomics of human-system interaction • EN 9241-11:2006 Usability Requirements • ISO DIN 20282-1 Ease of operation of everyday products • EN 60601-1-6:2010 Safety and Usability for electrical Medical Products • EN 15038:2006 Quality of translations

5. EN Standards (product/ instructionmanualrelated) PRODUCT - related INSTRUCTIONS-FOR-USE -related Risk Assessment - RiskReductionEN ISO 12100:2011 PreparationofinstructionsforuseIEC 82079-1:2012 • Annex B (Conformity) • Annex C (Communication Effectiveness) SafetyInstructions SafetyWarnings + Productspecific EN-Standards • SafetyInstructionsdefined • DeclarationofConfornity CE • Certification / Safety-Requirements SafetyInstructions SafetyWarnings + + Country Deviations Optimizationbased on usabilitytestevaluationswithusers (user/consumertests) • Usability - Ergonomics EN ISO 9241:11 Usabilityrequirements + productspecific C standards

6. Production Process of Instruction Manuals • Requirements • - System & product analysis • - User and application analysis • - User requirements, user cases .. • Basic concept (IEC 82079-1) • - Structure / content, styling • - Simple manual prototyping • Evaluation 1: (EN 12100) • - Usability expertise • - Review of Standards, Risk analysis • - Optimization First Draft (IEC 82079-1), Annex B+C important! • - Design concept with full contents • Evaluation 2: (EN ISO 9241, Prod. Safety Standards) • Usabilty test with users, optimization • Special safety instructions Final Draft (IEC 82079-1) Complete User Manuals • Printing Translations(EN 15038)

7. Conformity of instrustion manuals with the Law • Is it possible to produce Manuals in conformity with the Law based on the Machinery Directive? • Unfortunately not! • The legal requirements incorporate only basic demands • Is it possible to produce Manuals in conformity with the Law by following the requirements of the Standards? • Very difficult! • IEC 82079:2012 andProduct-Specific Standards containmanysingle • requirements,whichrequire expert knowledgefromtechnicalwritersin • ordertobeimplemented

8. IntendedUse • GPSG §2 - Conceptdefinitions (5) IntendedUseis: 1. theuseforwhich a Productissuitable, accordingtothestatementsand informationoftheproducerorimporter 2. theusualusewhichresultsfromthe design andimplementationoftheproduct • 2006/42/EC Annex I 1.1.1 h) "intendeduse"meanstheuseofmachineryin accordancewiththeinformation provided in theinstructionsmanual • 2006/42/EC Annex I 1.7.4.2 Each instructions manual must contain, where applicable, at least the following information: g) a description of the intended use of the machinery

9. Sample for risk assessmentEN ISO 12100:2010 Part 2

10. Risk assessment structure Hazard identificationHazard assessment  Operation anduse 6 weighingcategories  Disturbances 4 probabilitiesofoccurrence  Environmental factors  Dangerousproperties

11. Risk assessment and risk reduction Procedure Prepare the Hazard Catalogue with Risk Assessment

12. Risk assessment and risk reduction Procedure Work out the Risk Profile for the particular product

13. Risk assessment and risk reduction Procedure Measures and Safety Instructions that need to be implemented

14. Compliance to Product Safety Standards

15. Compliance to Country Deviations

16. Compliance to other European Directives WEEE and others like: EMC, etc.

17. Usability Evaluation - Consumer testISO EN 9241-11ISO DIN 20282-1and the respective product specific C-Standards Part 2

18. Usability Evaluation Usability Laboratory

19. Evaluation von echten Benutzern Usability Testing in the Lab: pragmaticoptimization

20. Evaluation von echten Benutzern Productand Manual testingwithusersfromvariousculturalbackgrounds

21. Usabilitytestquestionnaire(1)

22. Usabilitytestquestionnaire(2) Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“; 4 – „sufficient“; 5 – „unsatisfactory"

23. Usabilitytestquestionnaire(3) Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“; 4 – „sufficient“; 5 – „unsatisfactory"

24. Usabilitytestresults Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“; 4 – „sufficient“; 5 – „unsatisfactory"

25. Consumer assessment of a washing machine manual Summary of individual comments and suggestions from the users: What do I like in the Manual: • Clear recognizable pictures • Short and good explanations • Better understanding compared to the purely textual manuals • The manual is easy to handle and overview • Attractive Design • Good overview, the information can be found fast and easy What I do not like in the Manual: • The graphics in Troubleshooting are not good recognizable • Some texts are not good readable especially under bad lighting • The information ”how long the door stays locked after finishing the washing” is found under ”Troubleshooting“. It should be found in the central graphic of the washing process • Letters are too small in some parts of the manual • Red text in grey background is difficult to read (safety instructions) • Reference to standards is not understandable by the users • Some difficulty when choosing the programs

26. Consumer assessment of a washing machine manual Consumer remarks during the tests: • Point 3 of the manual “Requirements for installation site” mentions a length of the cable to the plug of 1.5m. Point 6 shows a cable length of 1m.These specifications are inconsistent and confuse the users. Under ”Preparation“: Points 1-4 are shown as recurrent actions. These actions, however, take place only once after the assembly of the machine. This should be made also clear. • It would be better if the transport safety parts were preserved at the machine. • Buttons ”OPTION“:One should be enough. • User manual: In the washing programs information for 95C0 is missing.

27. STIWA - Evaluation of Instructions Manuals

28. STIWA - Evaluation of Instructions manuals

29. Part 3: ISE Europe GmbH, alliance network

30. Part 3: ISE Europe GmbH, alliance services Risk Analysis - Standards ・Coordination servicesDepending upon the product’s features and points of destination, coordinate with prestigious certification institutions and translation service companies ・ One-stop servicesProvide required product certifications and document productions for target markets in Europe ・Risk AnalysisRisk analysis of products. Safety instructions. Product Safety Standards. Technical Expertise ISE Europe GmbH Translation Services Usability-Ergonomics ・Provides services near customersExpansion of 10 base offices in Europe and Asia ・Multilanguage translation servicesProvides high-quality translation services for more than 200 languages ・LocalizationsLocalizations for website translations and software applications ・ Terminology managementTerminology management that is supported by experience in multilanguage translation services ・ DTPExperience in online data and Multilanguage printing ・Product testingConduct professional product testing at usability laboratories, and optimize usability via observations ・User-centered designingSupport design processes centered upon users, and sublimate product ideas to final products which provide user-friendliness ・ User experiencesBirth loyal customers and the acceptance of products in markets via clearer user experiences ・ Visalyser testingTools for measuring the visual impacts that pamphlets and websites bring about

31. Part 3: ISE EuropeGmbH, partner companies in Asia •  ISE (Beijing) Inc.  ISE Inc., Tokyo, Japan • Mr. Yang YongxunMr. Satoshi Kuroda • Telephone: +86 10-6463-8124 Telephone: +81 3 3368 4687 • E-mail: ise-china@ise.jp E-mail: satoshi.kuroda@ise.co.jp

32. Thankyouforyourattention謝 謝