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Instructions for Use

Use this Instructions for Use (IFU) template to provide essential, compliant guidance on the safe and effective use, installation, and maintenance of your medical device, including details on intended use, indications, warnings, and troubleshooting. This document is required to accompany your device at release and must be updated whenever there are significant changes to the product, ensuring users and regulatory bodies have up-to-date information for safety and performance. Properly completed IFUs are critical for meeting regulatory requirements, reducing user error, and supporting product registration in the EU and US markets.
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Instructions for Use

Lorem Ipsum Device
IFU Release Date: Dolor sit amet 2023-07-01

ID: Consectetur-12345

Table of Contents

Introduction

These instructions are intended for the correct use of Lorem Ipsum Device. Please read the information and follow the instructions contained therein. Please reach out to our support team for additional help.

Device

Intended Purpose

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Indications for Use

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Functionality

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Device Compatibility Requirements

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Intended Users

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Contraindications

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Accessories

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Safety Information and Side Effects

Warnings and Precautions

Caution Symbol



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Adverse Events

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Security and Setup

Installation

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Training Required

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Security

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Instructions

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Technical Assistance

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Release Date

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Additional Information

In the case of any serious incident that has occurred in relation to the use of Lorem Ipsum Device, report it immediately. Information for reporting the incident can be found in this IFU or on our website.
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Explanation of Symbols and Abbreviations Used on Product Label