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Storz VITOM EAGLE - User Manual

Storz VITOM EAGLE
36 pages
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Instructions for use
VITOMEAGLE
en

Table of Contents

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Summary

General Information

Read Use Instructions

Essential guidance for safe and effective product operation.

Compatible Product Guidance

Guidance for using compatible products alongside the main device.

Manual Scope Definition

Defines the applicability and content of this manual.

Document Symbols and Signs

Explains standard signs and symbols used throughout the document.

Warning Message Levels

Details the different levels of danger indicated by warning messages.

Normal Use Scenarios

Intended Use and Purpose

Specifies the primary purpose and intended application of the 3D Exoscope.

Approved Indications

Lists the medical procedures or conditions for which the exoscope is suitable.

Usage Contraindications

Outlines situations or medical specialties where the product must not be used.

Clinical Benefits Overview

Describes the advantages and improvements offered by the exoscope in surgical settings.

Identified Residual Risks

Identifies any remaining risks associated with product usage after mitigation.

Target User Qualifications

Specifies the qualified professionals authorized to use the medical device.

Patient Group Considerations

Details any restrictions or considerations regarding patient groups.

Operating Environment Requirements

Specifies the environmental and setting requirements for product use.

Safety and Warning Guidelines

Serious Incident Definitions

Defines what constitutes a serious incident and reporting requirements.

Safe Handling and Testing

Guidelines for correct product handling, inspection, and maintenance.

Component and Modification Safety

Rules for combining components and prohibitions on product modifications.

Hygiene and Infection Control

Procedures and risks related to product cleanliness and reprocessing.

Electrical Hazard Prevention

Warnings and guidelines regarding electrical power supply and shock hazards.

Patient Leakage Current Risks

Information on accumulating patient leakage currents and associated risks.

Electromagnetic Interference Management

Precautions regarding electromagnetic compatibility and potential interference.

Light Cable Compatibility

Guidance on selecting appropriate fiber optic light cables to prevent damage.

Component Heat Safety

Warnings about hot components and measures to prevent burns.

Light Intensity Safety

Risks associated with high light intensity, including eye damage.

Product Failure Preparedness

Guidance on preparing for potential product failures during use.

Product Description and Specifications

Product Overview and Parts

Visual identification and description of the product's main parts.

System Component Compatibility

Lists recommended combinations of products for system integration.

Packaging Symbol Meanings

Interpretation of symbols found on the product packaging.

On-Product Symbol Explanations

Explains symbols and markings directly applied to the product.

VITOM EAGLE Technical Data

Provides detailed technical data and requirements for the VITOM EAGLE.

Environmental Operating Conditions

Specifies temperature, humidity, and pressure requirements for storage and operation.

Product Preparation Procedures

Unpacking and Initial Checks

Instructions for safely unpacking and checking the product upon receipt.

Reprocessing Instructions

Guidance on reprocessing the product before use, referencing separate instructions.

IMAGE1 PILOT Assembly

Step-by-step guide for assembling and connecting the IMAGE1 PILOT unit.

VITOM EAGLE Connection Guide

Instructions for correctly connecting the VITOM EAGLE to power and other components.

Sterile Drape Application

Procedure for applying sterile drapes to maintain asepsis during procedures.

White Balance Calibration

Detailed steps for calibrating the system's color balance before use.

Application and Operation

Image Horizon Adjustment

How to adjust the image's horizontal alignment and rotation for optimal viewing.

Optical Function Control

Managing exoscope functions like zoom and focus using control units.

Region of Interest Selection

Method for navigating and selecting specific areas within the displayed image.

VITOM EAGLE Button Functions

Explanation of the functions assigned to physical buttons on the VITOM EAGLE.

IMAGE1 PILOT System Control

How to navigate and control the IMAGE1 S system using the IMAGE1 PILOT.

IMAGE1 PILOT Programmable Buttons

Details on programmable button functions for the IMAGE1 PILOT.

Image Lighting and Modes

How to adjust illumination and activate special modes like Fluorescein and BLI.

PIP-Swap Image Switching

How to switch between primary and secondary image sources.

Product Disassembly

Disassembly Procedure

Step-by-step instructions for safely disconnecting and dismantling the product.

Maintenance, Service, and Disposal

Safety Inspection Protocol

Guidelines for periodic safety inspections and their importance.

Authorized Repair Services

Information on who can perform repairs and how to contact support.

Product End-of-Life Disposal

Instructions for environmentally responsible disposal of the product.

Accessories and Spare Parts

Available Accessories List

List of accessories and their order numbers for purchase.

Electromagnetic Compatibility (EMC)

EMC Guidelines and Usage

Details on EMC compliance and considerations for use in different environments.

KARL STORZ Subsidiaries

Global Contact Information

Contact details for various KARL STORZ subsidiaries worldwide.

Storz VITOM EAGLE Specifications

General IconGeneral
BrandStorz
ModelVITOM EAGLE
CategoryMedical Equipment
LanguageEnglish

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