The goal of this template is to give a structure for the user guide. Its presentation is not user-friendly. Add you cover page, logo, look-and-feel etc… Add also the CE Mark on the cover page, if necessary. The identification of the document shall also be clear, add the identifier and revision date of the document on the cover page or somewhere where it is easily visible. TABLE OF CONTENTS 1 Introduction 2 1.1 Conventions 2 1.2 Intended use 2 2 Precautions 2 2.1 Compliant Use 2 2.2 Safety instructions 3 2.2.1 Electromagnetic interferences 3 2.2.2 Electrical connection 3 2.2.3 Environment 3 2.2.4 Storage conditions 3 2.3 Malfunction 4 3 Installation 4 4 Getting started 4 5 Advanced functions 4 6 Maintenance 4 7 Cleaning and Disinfection 4 8 Error Messages, troubleshooting 4 9 Bibliography 5 10 Warranty 5 11 Legal Notices 5 11.1 Disclaimer 5 11.2 Copyrights and trademarks 5 12 Manufacturer Contact Information 5 1 Introduction This document is the user guide for XXX, a device designed by . It is recommended that you read this instruction manual carefully before use. If your software uses accessories, give the list below This product can only be used with accessories delivered by : • List of accessories with references • An accessory • Another accessory The use of any other accessories is forbidden. Please, read carefully the precautions with symbols, to ensure that the device is used in best conditions and in complete safety. 1.1 Conventions Typographical convention. Any other convention. To avoid all physical and material damage, this document splits safety instructions into 3 danger levels. ATTENTION Hazardous situation which can cause material damage or lead to moderate serious injury. WARNING Hazardous situation which can cause serious/ fatal injury. Hazardous situation which could immediately cause serious/ fatal injury. 1.2 Intended use Add here the intended use of your device 2 Precautions 2.1 Compliant Use The use of this device is reserved to XXX (give the specialty of physicians or if they need a training or an education level), or under their control. Any inappropriate use is forbidden. The user shall: • Only use non-defective products. • Protect patients, third parties, other operators, assistants and themselves from all danger. • Avoid all contamination by the product (remove this if you don’t sell hardware). The user must check the safety of operation and the condition of the device before each use. Verify that the product is operational at all times and keep it in good working conditions. Only technicians are authorized to repair products. 2.2 Safety instructions Add any instructions related to safety, especially mitigations actions from risk analysis 2.2.1 Electromagnetic interferences If you sell hardware + software, then this part is important. If you sell only software you can remove it. Example of safety instruction, add any other safety instruction: The device is certified compliant with current electromagnetic compatibility standards. ATTENTION Users should ensure that no electromagnetic interference raises an additional risk. So as not to disturb the proper operation of electromagnetic devices, it is recommended complying with the recommended separation distances for the device. ( give separation distances) 2.2.2 Electrical connection If you sell hardware + software, then this part is important. If you sell only software you can remove it Example of safety instruction, add any other safety instruction: DANGER Bad electrical connection - ELECTRIC SHOCK - ELECTROCUTION Check that the supply voltage is the same as that shown on the device. Check the supply cable before each use. Never plug or unplug the device to/from a wall socket with damp hands. Any other use or connection of devices or peripherals to a port (USB, serial, parallel …) may create new risks and may require additional risk analysis 2.2.3 Environment If you sell hardware + software, then this part is important. If you sell only software you can remove it. Add safety instructions about environment, like presence of explosive gases (anesthetics), fluids, temperature, mechanical constraints … 2.2.4 Storage conditions If you sell hardware + software, then this part is important. If you sell only software you can remove it. Add safety instructions about recommended storage conditions … 2.3 Malfunction In case of malfunction: • Immediately stop using the device. • Try to identify or eliminate the cause using the description in this document (section Error messages, troubleshooting). • If it is not possible to identify or eliminate the cause using this document, switch the device off and call After-Sales Department (see Manufacturer section at the end of this document). 3 Installation - unistallation Optional, you may remove this section and describe installation in a separate installation manual Describe the installation and uninstallation of the hardware and software. Hardware and/or software installation may be only realized by technicians of your company. In this case, remove this section and describe installation in another (internal?) document. 4 Getting started First use of software by the user, explain main and/or simple use cases, and main workflow. 5 Advanced functions Advanced use, describe more complex use cases and/or secondary functions 6 Maintenance Optional, you may remove this section and describe installation in a separate maintenance/administrator’s manual Describe the maintenance of the hardware and software. Hardware and/or software maintenance may be only realized by technicians of your company. In this case, remove this section and describe installation in another (internal?) document. 7 Cleaning and Disinfection If you sell hardware which shall be cleans and disinfected. Otherwise you can remove it. You may rename this section “Cleaning, Disinfection and Sterilization” is you have instructions about sterilization. Describe how the device shall be cleaned and disinfected. Is your hardware protected by screens, sheaths, if it is a medical PC, how to clean the screen, the mouse & keyboard … 8 Troubleshooting, Error Messages This section is intended to help users, should a problem occur. In the event of abnormal operation, immediately stop using the device and call After-Sales Dept. If it is not possible to locate or eliminate the problem using this section, or if the dysfunction is still present, switch off the device and call After-Sales Dept. DANGER Never try to repair this device alone Error message Description Your error message Description of the error and how to fix it, if possible Not enough disk space (err 123) Empty disk using xxxx Malfunction Causes Solutions The malfunction • The cause • The solution, if any, or call after-sales The PC doesn’t start • It is unplugged • Plug it to main (I Love this one !!!) 9 Bibliography Optional. Add here bibliography, clinical data that are relevant to the use of the device. 10 Warranty Warranty terms and conditions. Not optional! … 11 Legal Notices Optional, ask your legal advisory! 11.1 Disclaimer Optional. The disclaimer is usual in software industry and is also often shown during software installation… 11.2 Copyrights and trademarks Optional. Add your copyrights and trademarks Add sentences like: Windows is a registered trademark of Microsoft Corporation in the USA and other countries. 12 Manufacturer Contact Information Address ZIP Code Country Contact Phone Fax