The operation manual is the most official and comprehensive reference to the operation and maintenance of a product or a device. Manuals provide conceptual information, such as design theory. An operating manual must contain all relevant information, features, procedures, and tasks to install, update, maintain and remove the product or software. It should also describe the main tasks and solutions to typical problems or questions in detail for the user.

The operation manual is aligned with the regulations, and it needs to be followed by the user. Any deviation found is unacceptable.

Contents of an Operation Manual

The operation manual consists of the following topics:

• Introduction: It, in brief, describes the product, explains the features, and states the document’s purpose.
• Installation or Pre-installation Requirements:
• This section lists all the prerequisites and dependencies necessary to install the device correctly. It includes specific hardware (e.g., type of CPU, RAM, type of hard drive (e.g., SSD), file system/partition, and required disk space)
• The required software with the required (minimum) version and release should also be defined. This could include the following elements:
  • Operating system: Linux, such as specific Linux distributions (Red Hat Enterprise Linux, Debian, Ubuntu) or Windows (Windows Server, Windows 11, etc.)
  • Application server: If required by your software, enter the details such as vendor, name, and version of the application server (if not automatically installed by your software's installer)
  • Libraries and additional software: If any specific software or library is required, please specify (e.g., .NET framework, JAVA SDK, etc.)
• Provide detailed software or system installation instructions, such as how to integrate single sign-on between the customer's cloud provider or on-premises or on the assembly of the device “Active Directory” and the user authentication module of employee integration products
• Operating Instructions: Includes a list of step-by-step instructions that are accurate and precise as possible. After the installation is complete, the configuration file and configuration settings can be updated. It is essential to list all necessary configuration files or screens along with configuration elements and possible values. As just providing default configuration and value may not be useful to all the customers. Readers need to be clear about what is to be checked and what is the expected result and outcome.
• Safety Instructions: The Safety Instruction notifies the user of the minimum safety requirements like preventive and protective measures. One must meet these measures to protect people from risks to their health and the safety of the equipment being used.
• Maintenance and Troubleshooting:
• Monitoring and maintenance of the system – e.g., check disk space, run security and safety audits, backup and recovery of data, archive old data, get and install updates and upgrades
• Information to handle typical questions and support requests by the end user for the support department of the customer – e.g., FAQ, link to support portal of the vendor, contact to vendor’s support for 2nd and 3rd level support to get assistance, along with the support level agreement (SLA), in addition to emergency procedures and guidance in case of human error or system outtake
• It might also contain additional Regulatory and privacy-related rules and requirements
• Uninstallation/Disassembly: It describes a list of step-by-step instructions on how to disassemble/uninstall hardware/software in a proper manner
• Additional Information: Any additional information that is required to support the operational procedures of the device or any other information can be listed and explained in detail in the process

Organizations should develop operation manuals that provide clear standard operating procedures (SoPs). The manuals and the information in the manual should contain important departmental inputs such as product development and testing, operation, maintenance, and customer service.

To know more about the operation manual of medical devices, reach out to Freyr experts.