| 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 <your company>. | |
| 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 <your company>: | |
| • 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 <your company> technicians are authorized to repair <your company> 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 <your company> 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 <your company> 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 <your company> 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 | |
| <Your Company> | |
| Address | |
| ZIP Code | |
| Country | |
| Contact Phone | |
| Fax | |