alea Instructions for Use (IFU)
Table of Contents
- 1 Foreword and important information
- 2 Scope
- 3 Contact details
- 3.1 Contact details of the manufacturer
- 3.2 Contact details of the distributor and manufacturer of the Diapers
- 4 Information on how to use these instructions for use
- 4.1 Explanation of the warnings in these instructions for use
- 4.2 Presentational conventions in these instructions for use
- 4.3 Glossary of Terms
- 4.4 Other accompanying documentation and additional information material
- 4.5 Legal Information: Copyright, disclaimer, license terms, warranty, miscellaneous
- 4.6 Feedback on instructions for use
- 5 Intended use
- 5.1 Intended medical purpose
- 5.2 Clinical benefit
- 5.3 Indications, Contraindications and Limitations
- 5.3.1 Indication for Use
- 5.3.2 Contraindications
- 5.3.3 Exclusions
- 5.3.4 Limitations
- 5.4 Patient target group(s)
- 5.5 Intended users
- 5.6 Intended use environment(s)
- 6 Important safety notes
- 6.1 Reporting of incidents
- 6.2 Contraindication
- 6.3 Undesirable side-effects
- 6.4 Hazards for vulnerable patient groups [and vulnerable user groups]
- 6.5 Qualification requirements for user groups
- 6.6 Personal protective equipment
- 6.7 Requirements/restrictions for the use environment
- 6.8 Shelf life
- 6.9 Avoiding risk of infection
- 6.10 Avoiding radiation damage
- 6.11 Additional safety notes regarding the intended use and foreseeable reasonable misuse.
- 7 Product description
- 7.1 Operating principle and process overview
- 7.2 Scope of delivery
- 7.3 Storage of the product before and after use
- 7.4 Shelf life
- 7.5 Required materials that are not included in the scope of delivery
- 7.6 Combination with other devices
- 7.7 Device overview
- 7.8 Controls
- 7.9 Signals and displays
- 7.10 Error notifications and warnings
- 7.11 Modifications
- 8 Accessories, resources, consumables, spare parts
- 9 Transport
- 9.1 Packaging dimensions, weight, center of gravity
- 9.2 Procedure during transport
- 9.3 Storage during transport
- 9.4 Protecting the device from vibration
- 10 Installation
- 10.1 General Information
- 10.2 Set up Docking Station
- 10.3 Set up Node
- 10.4 Hardware Assignment
- 10.5 Changes to the installation
- 10.6 Minimum IT environment requirements (for PES and SW)
- 10.7 Check for proper functionality
- 10.8 Installation and Setup for use of Web App
- 10.9 Installation and Setup of the Mobile App
- 11 Device use
- 11.1 Usage of alea Clip
- 11.2 Usage of Docking Station
- 11.3 Usage of Web App
- 11.4 Usage of Mobile App
- 11.5 Perform task ‘Connect Clip to the Diaper
- 11.6 Perform task ‘Patient Management within Mobile App / Webapp’
- 11.7 Perform task ‘General Administration within Web App’
- 12 IT-Security
- 12.1 IT environment requirements
- 12.2 IT security measures to be implemented
- 12.3 Handling lost or stolen authentication elements
- 12.4 IT security problems and countermeasures
- 13 Cleaning, disinfection, sterilization
- 14 Maintenance/Servicing
- 15 Disassembly, recycling, disposal
- 15.1 Disassembly
- 15.2 Recycling & Disposal
- 15.3 Data handling during disposal
- 16 Troubleshooting
- 16.1 Troubleshooting and correction by laypersons
- 16.2 Troubleshooting and correction by authorized specialists
- 17 Repair
- 18 Device specifications
- 18.1 Device dimensions
- 18.2 Third-party components
- 18.3 Device Qualification Classification
- 18.4 Device conformity
- 18.4.1 List of Applicable Standards
- 18.4.2 List of Symbols and Explanation
- 19 Revision history of the instructions for use
