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Fresenius Kabi Conox 2D User Manual

Fresenius Kabi Conox 2D
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Conox® 2D
Depth of Anesthesia Monitor
Instructions for Use

Table of Contents

Questions and Answers:

Fresenius Kabi Conox 2D Specifications

General IconGeneral
CategoryMedical Equipment
ManufacturerFresenius Kabi
ModelConox 2D
DisplayLCD
InterfaceRS-232

Summary

General Information Conox Monitor

Scope of Instructions for Use

Provides an overview of the Instructions for Use manual for the Conox monitor.

Intended Purpose of Conox Device

Defines the device's primary function in monitoring patient consciousness during anesthesia.

Clinical Benefits of Conox Monitor

Details the advantages of using the Conox monitor in clinical practice.

Indications for Conox Use

Specifies the patient population and conditions for which the device is intended.

Safety Guidelines for Conox Device

General Safety Instructions

Crucial safety guidelines for operating the Conox device to prevent hazards.

Electromagnetic Compatibility

Details the device's conformity with electromagnetic compatibility standards.

Safety Symbols Explained

Explains the meaning of various safety symbols used on the device and labeling.

Packaging Symbols

Illustrates and explains symbols found on the product packaging.

Conox Device Description

System Description

Explains how the Conox device works and its basic operational principles.

System Overview

Details the main components of the Conox system: Sensor, Cable, and Main Unit.

Controls and Indicators

Identifies and describes the device's on-screen controls and visual indicators.

qCON Index Explained

Explains the qCON index, its meaning, and its correlation with patient consciousness.

qNOX Index Explained

Details the qNOX index, its interpretation, and its relation to patient response.

Burst Suppression Ratio (BSR)

Describes the BSR parameter and its significance in detecting deep anesthesia.

Electromyography Index (EMG)

Explains the EMG index and factors that can increase its value.

Signal Quality Index (SQI)

Defines the SQI and its role in assessing EEG signal quality.

EEG Waveform Display

Describes the graphical representation of the EEG signal.

Spectrogram Display

Explains the spectrogram as a representation of EEG signal frequency content.

Parameter Trend Graphs

How to view trend graphs for selected Conox parameters.

Electrode Impedance Monitoring

Details how the device measures and displays electrode-to-skin impedance.

Battery Status Indicator

Explains the visual indicators for the device's battery charge level.

Bluetooth Indicator

Describes the indicator for Bluetooth® status and data transmission.

SD Symbol Status

Explains the symbols indicating the status of the on-board memory.

Time Settings

Information on displaying and setting the device's system time.

Elapsed Time Tracking

Details how the device tracks and displays elapsed time for sessions.

Device Status Messages

Lists and explains the different status messages the device can display.

Sensor Status Monitoring

Describes how the device monitors and reports the status of the patient sensor.

Setup Procedures for Conox

Unpacking the Device

Instructions for safely removing the device and its components from packaging.

Contents of the Box

Lists the items included in the product packaging.

First Time Installation

Steps for initial installation and setup of the Conox device.

Setup Menus Overview

Guides on accessing and navigating the device's setup menus.

Operating Modes

Describes the two operational modes: Recording mode and Data Repository mode.

Recording Mode Settings

Guides on how to access and configure settings within the Recording mode.

Information Screen Details

How to view device firmware, hardware, software, and serial number.

Language Settings

Instructions for changing the device language from the available options.

Time and Date Settings

Instructions for setting the current time and date on the device.

Bluetooth Connectivity

Steps to enable, disable, and pair the device's Bluetooth® connectivity.

Trends and Spectrogram Settings

How to configure settings for trend graphs and spectrogram display.

EEG Settings Configuration

Guides on adjusting EEG graph amplitude and timescale.

qCON Advisory Signal

How to enable and configure the qCON advisory signal for alerts.

Data Repository Access

How to access and navigate the Data Repository mode for recorded data.

Display Brightness Adjustment

Instructions for adjusting the display brightness level of the device.

Data Repository Mode Settings

Advanced settings for the Data Repository mode, including file format.

File Format Selection

Options for selecting the data file format for recording and storage.

Delete Temporary Files

Procedure to clear temporary files from the device's memory.

Delete All Bookmarks

Procedure for clearing all saved bookmarks from the device's memory.

Recording a New Case

Data Repository Mode Operations

Accessing Data Repository

How to activate and enter the Data Repository mode on the device.

Understanding Data Folders

Explanation of the 'Temporary files' and 'Bookmarks' folders in Data Repository mode.

Managing Recorded Cases

How to view and manage recorded patient data files.

Downloading Recorded Cases

Steps to download recorded data from the Conox device to a PC.

Adding Cases to Bookmarks

Procedure to save important recorded cases to the bookmarks folder.

Reviewing Saved Cases

How to view the recorded trends and data of a previously saved case.

Deleting Recorded Cases

Instructions on how to permanently remove recorded cases from the device.

Using the Conox Device

Device Positioning Guidelines

Guidance on where and how to position the Conox device for optimal use and safety.

Patient Sensor Handling

Information on handling and preparing the patient sensor for use.

Skin Preparation for Electrodes

Instructions for preparing the patient's skin prior to electrode application.

Electrode Placement

Detailed steps for correctly applying the EEG electrodes to the patient's forehead.

Connecting Cable and Powering On

Steps for connecting the patient cable and powering on the Conox device.

Impedance Check Procedure

Explanation of how the device checks and displays electrode-to-skin impedance.

Event Sequence and Operation

Describes the sequence of operations when the device is turned on.

Handling Disconnected Patient Cable

Describes the 'lead off' status and actions for a disconnected patient cable or sensor.

External Power Supply and Battery

External Power Supply Details

Details the specifications and usage of the device's external power adapter.

Internal Battery Information

Information on the internal rechargeable battery, its life, and charging.

Cleaning and Disinfection

Service Policy and Rules for Cleaning

Guidelines on prohibited cleaning agents to prevent device damage.

Cleaning Precautions

Important precautions to follow during the cleaning process of the device.

Cleaning Instructions

Step-by-step guide for cleaning the Conox device and its accessories.

Disinfection Instructions

Step-by-step guide for disinfecting the Conox device and its accessories.

Adverse Effects of Conox Use

Troubleshooting and Diagnostics

Conox Alarms and Solutions

Details various alarm messages, their possible causes, and corrective actions.

Device Troubleshooting Guide

Provides solutions for common device issues and diagnostic information.

Service and Maintenance

Warranty Information

Information regarding the warranty period and terms for the device and accessories.

Maintenance Requirements

Details on recommended preventive maintenance and service intervals.

Service Policy and Rules

Guidelines for device servicing and return procedures.

Recycling and Safe Disposal

Instructions for proper disposal of the device and its components, including batteries.

Notification of Serious Incidents

Procedure for reporting any serious incidents related to the device.

Electromagnetic Immunity

Recommended Separation Distances for RF Equipment

Guidance on maintaining safe distances from RF equipment to prevent interference.

System and Environment Specifications

Essential Performance Criteria

Outlines the core functions and capabilities the device must perform.

System Specifications

Provides technical details of the monitor, including dimensions, weight, and components.

Operation and Shipment Conditions

Specifies the environmental conditions for device operation, transport, and storage.

Cybersecurity Recommendations

Declaration of Conformity

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