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Operating Intructions (Beta)

This section describes how CERTAIN can assist you in the preparation of your operating instructions. This normally time consuming task has been integrated into the CERTAIN workflow as a key process step and developed so as to minimise the effort needed, eliminate reentry of already existing information and be structured in full conformance with:

DIN EN ISO 20607 / DIN EN 82079-1.

We have developed this powerful tool in-house to be selfexplanatory and to guide you on your way with templates and editing features to help you with text formatting, adding pictures, graphics and tables, creating lists, and much more.

The revision-controlled and fully formatted instructions are finally rendered as a pdf together with the other CE documents in the last process step, with no further editing or changes required. Simply download and you're done.

This guide is designed to give you a helping hand if you are unsure about certain aspects or features of the tool and also to provide some background of the relevance and importance of operating instructions as an inherant part of the CE marking process.

💡 Operating instructions and CE compliance​

The operating instructions (operating manual) for a machine or piece of equipment play a crucial role in the CE marking process, and particularly under Directive 2006/42/EC (Machinery Directive). Their primary function is to ensure that the machine can be transported, assembled, installed, operated, maintained, and disposed of safely while complying with essential health and safety requirements. Here’s how they fit into the CE conformity process:

1. Essential Requirement Under the Machinery Directive and other directives

  • Annex I of Directive 2006/42/EC specifies that machinery must be accompanied by instructions containing all necessary safety information.
  • The manual must provide details for safe operation, maintenance, and troubleshooting , ensuring that users do not face unnecessary risks.

2. Part of the Technical Documentation

  • The operating instructions are an essential component of the technical file required for CE conformity.
  • They serve as evidence that the manufacturer has considered all relevant risks and implemented necessary safety measures.
  • Notified Bodies (if applicable) or authorities may request these documents during inspections.

3. Risk Assessment and Compliance

  • The content of the manual should align with the risk assessment carried out according to EN ISO 12100 (Safety of Machinery – Risk Assessment and Risk Reduction) .
  • It must describe information such as intended use , foreseeable misuse and include any residual risks that could not be eliminated by design.

4. Language and Standardization Requirements

  • The manual must be provided in the official language(s) of the country where the machine is placed on the market .
  • It should comply with DIN ISO 20607 (Safety of Machinery – Instruction Handbook) and ISO 12100 , ensuring clarity, completeness, and proper structuring.

5. Content Requirements

Operating instructions must include for example:

  • General information (manufacturer, model, serial number, year of construction)
  • Intended use and foreseeable misuse
  • Installation and assembly instructions
  • Operating instructions (starting, stopping, normal operation)
  • Safety instructions (PPE, emergency procedures, warning signs)
  • Maintenance and servicing (lubrication, part replacement)
  • Disposal instructions (environmental compliance)

6. Impact on CE Conformity

  • Incomplete, unclear, or incorrect operating instructions can invalidate the CE marking .
  • Missing or inadequate safety information may lead to legal consequences , including liability for accidents.

Conclusion

The operating instructions are not just a formality but a legal and safety-critical document . They demonstrate compliance with essential safety requirements , ensuring both regulatory conformity and user protection . Properly structured and well-translated instructions are mandatory for successful CE certification.

1. Click on Instruction manual (Operating instructions)​

You will be directed to the instructions assistent.

2. The operating instructions assistant. An overview.​

The assistant page is split into two parts. On the left is a structured table of contents listing the main chapters, subchapters and their contents.

On the right hand side is the editing window.

We have prepared an extensive template document for you to use and to edit to meet your needs. When opening this assistant for the first time this template is visible in the editing window and provides you with a preliminary draft to begin working on imediately.

A standard content structure and descriptive texts have been inserted to help you to edit and prepare this document much more quickly and easily than starting with a clean sheet or blank page.

It is designed to help you on your way.

3. The editing window​

In the editing window you are free to type, insert or delete text at any location, add empty lines as you require.

The individual elements of the operating instructions are added here in the order and structure they will appear in the final rendered document. The rendering process will take care of the final document creation including a table of contents and formatting, adding for example page breaks and page numbering, front and back pages etc.

When leaving this page always save your changes using the save button top right.

4. The toolbar​

The following formatting and insertion tools are available for you at the top of the editing window in the toolbar.

  • Bold / Italic / Underline / Highlight
  • H2 Subheading size 2
  • H3 Subheading size 3
  • H4 Subheading size 4
  • Bullet list / numbered list
  • Insert a table / Insert an image
  • Insert an information box in blue
  • Insert a caution box in yellow
  • Insert a warning box in orange
  • Insert a danger box in red
  • Insert a project information placeholder (see explanation below)

5. Using placeholders (x)​

Within the template we have integrated placeholders which contain product or project information that you entered in a previous process step. You do not need to reenter this. It will be inserted into the final document and your changes are automatically reflected in your latest version.

If you update your project information at a later date, you do not have to edit your instructions. That information will be passed on to the next revision of all your documents automatically.

You can insert these placeholders at any location throughout the document by selecting them from the dropdown menu in the toolbar (x)

💡 Placeholder examples​

Placeholders are fields or "keys" containing pre-entered project information. Here are some examples of the information available for you to insert into your document using the dropdown menu (x) from the toolbar.

  • Manufacturer information
  • Product designations and technical specifications
  • Intended use and foreseeable misuse
  • Technical specifications
  • Product limits

By clicking on the dropdown (x) in the toolbar, the full list is displayed.

6. Help texts and explanations​

Within the template document we have included >help notes< highlighted in yellow.

They are to assist you during the process providing tips and additional information we think are relevant or helpful. Simply delete them from the temple before proceeding.

7. Jump to a chapter​

To jump to a main chapter, click on the chapter title in the table of contents on the left.

8. Add a chapter​

To add a new main chapter to the document click on new chapter at the top of the table contents. It will be added at the bottom and named "new chapter". Simply click on the new chapter to move to it and begin editing.

9. Finish adding elements to your document​

Build, structure and format your instructions step by step including all the elements and information relevant to the chapters listed.

The yellow highlighted texts are there to help.

You can return to previous process steps, including product information or machine limits and ammend entries, texts, documents and illustrations as you need. The placeholders will be updated automatically and your document will be once again ready for the creation of your next controlled revision.

When leaving this page always save your changes using the save button top right.

💡 Creating great operating instructions!​

When creating operating instructions for a machine or device, clarity, completeness, and compliance are key. Here’s some practical advice to ensure that the manual is effective, user-friendly, and legally compliant:

1. Prioritize Clarity and Simplicity

  • Use plain, concise language that is easy to understand. Avoid overly technical jargon unless necessary.
  • Be direct and instructive (e.g., instead of "It is recommended that the power switch is turned off," write "Turn off the power switch").
  • Use active voice for instructions (e.g., "Press the emergency stop button" instead of "The emergency stop button should be pressed").

2. Use a Logical and Standardized Structure

  • Whenever possible and applicable use the suggested template content structure .
  • Follow a consistent format across sections.
  • Use clear headings, subheadings and steps to improve readability.
  • The table of contents will be provided for you, based on your content.

3. Support Instructions with Visual Aids

  • Diagrams, images, and illustrations to help users understand instructions faster than text alone.
  • Use consistent labeling between images and text (e.g., if a component is labeled “A” in an image, use the same reference in the text).

4. Ensure Instructions Cover All User Scenarios

  • Normal Operation – How to start, operate, and stop the machine.
  • Setup & Installation – Including space requirements, connections, and environmental conditions.
  • Maintenance & Servicing – Regular maintenance schedules, part replacement, and lubrication.
  • Troubleshooting – Step-by-step solutions for common issues.
  • Disposal & Recycling – Environmental compliance at the end of the machine’s life cycle.

5. Adapt for Different Audiences

  • Operators : Focus on daily use and safety .
  • Maintenance personnel : Provide detailed servicing procedures .
  • Installers : Include clear setup and commissioning steps .

Final Thought

A well-crafted manual is more than a regulatory requirement—it improves user safety, reduces liability risks, and enhances customer satisfaction . Focus on clarity, structure, compliance, and usability to create effective operating instructions.

10. Save your operating instructions​

Make sure you capture all your changes and save the current version by clicking on the save button top right.

You can then return to your product overview by clicking on the product name tab top left.

11. Publish the operating instructions​

If you wish to render a current version of the operating instructions you can do so in the process step "CE documentation". From the product overview screen, click on CE Documentation at the bottom.

12. Publish a new revision​

At this stage you are already familiar with the rendering process. By clicking on "Create complete document revision set", a new version of the entire project documentation will be generated. This includes:

  • The newly prepared / updated operating instructions
  • The risk assessment
  • The relevant declaration
  • The machine name plate

These may be previewed by clicking " PDF preview " on the right or downloaded by selection on the left and clicking " Download selected documents "

The newly allocated revision number is also listed in the table.

You may revisit this CE Documentation area and republish at any time following any changes to project data, risk assessment information or updates to the operating instructions.

When done you may return to the product overview or product list.

13. Preview your operating instructions​

The rendering process takes all the individual elements you have prepared and assembles them into a final formatted document with a title page and a back page, with footers and page numbering in place and nothing left to edit.

Just download and save for subsequent use or print if a hard copy is required.

When done you may return to the product overview or product list.

💡 Revision control!​

Why do all the documents have to be given a new revision number and not just the one that has been amended?

All documents need to be given a new revision number because changes to project data or any document can affect the entire project. If only the amended document receives a new revision number, other documents might remain outdated, leading to inconsistencies and potential legal issues. A unified revision number ensures that all documents are synchronized and contain the latest information and changes. This way, the entire documentation remains up to date and ensures compliance with regulations.

(v0.0.3)