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Enraf Nonius Endomed 182 User Manual

Enraf Nonius Endomed 182
52 pages
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Page 1 of 52 EN109-1634750-40 IFU
Endomed 182
EN109-1634750-40 IFU
September 21, 2020
Instructions for use
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Enraf Nonius Endomed 182 Specifications

General IconGeneral
Therapy TypeElectrotherapy
Channels2
DisplayLCD
WaveformsInterferential, TENS
ApplicationPain relief, muscle stimulation

Summary

1 Introduction

Foreword

Introduction and purpose of the manual.

Device Description

Overview of the Endomed 182's features and versions.

Endomed 182 Versions

Details the three available versions of the Endomed 182.

Current Wave Description

TENS Waveform

Explains TENS waveform, including biphasic pulsed current and Burst TENS.

Interferential Current (IFC)

Describes IFC, its advantages, and variations.

Two-Pole Interferential Method

Explains the two-pole method of Interferential Current therapy.

3 Device Components

Endomed 182 Type 1 Components

Identifies components of the Endomed 182 Type 1.

Endomed 182 Type 2 Components

Identifies components of the Endomed 182 Type 2.

Endomed 182 Type 3 Components

Identifies components of the Endomed 182 Type 3.

Numbered Parts Description

Lists and describes numbered parts of the device.

4 Package Contents

Device Models

Lists the available models of the Endomed 182 device.

Standard Accessories (Type 1)

Lists standard accessories included with Endomed 182 Type 1.

Standard Accessories (Types 2 & 3)

Lists standard accessories included with Endomed 182 Types 2 and 3.

Additional Accessories (Type 3)

Lists additional accessories specific to Endomed 182 Type 3.

Optional Accessories (Type 1)

Lists optional accessories available for Endomed 182 Type 1.

Optional Accessories (Types 2 & 3)

Lists optional accessories available for Endomed 182 Types 2 and 3.

5 Installation

Inspection and Unpacking

Steps to check delivery, unpack, and inspect the device for damage.

Device Setup and Connections

Guides the setup and connection of modules and mains supply.

Disconnection of Mains Supply

Procedures for safely disconnecting the device from power.

6 Intended Use and User

Intended Use of Endomed 182

Defines the purpose and target applications for each Endomed 182 type.

Intended User Profile

Specifies the qualified professionals who can operate the device.

7 Indications

Indications for Type 1 (Percutaneous Electrolysis)

Lists conditions treatable with Percutaneous Electrolysis using Type 1.

Indications for Types 2 & 3 (TENS/IFC)

Lists conditions treatable with TENS and IFC using Types 2 & 3.

Muscle Stimulation Indications

Lists applications for muscle stimulation.

Bowel Dysfunction Indications

Lists applications for bowel dysfunction.

8 Contra-indications

Contra-indications for Type 1

Lists absolute contraindications for using Endomed 182 Type 1.

Treatment Site Restrictions

Identifies specific body areas where treatment is prohibited.

Percutaneous Electrolysis Precautions

Highlights regions requiring special caution for PE.

Contra-indications for Types 2 & 3

Lists absolute and relative contraindications for Types 2 & 3.

TENS and IFC Precautions

Advises on precautions when using TENS and IFC.

Potential Adverse Effects

Describes possible side effects of electrotherapy.

9 Precautionary Instructions

General Safety and Usage Precautions

Covers device handling, environment, patient interaction, and stimulation placement.

Electrode, Maintenance, and Error Handling

Addresses electrode use, cleaning, maintenance, and error response.

Accessory and EMC Precautions

Details precautions regarding accessories, RF equipment, and power cables.

10 Operation

Initial Setup and Navigation

Guides device setup, power-on, and Home Menu navigation.

Frequently Used Functions

Overview of selecting protocols, favorites, and manual operation.

System Settings Configuration

How to access and modify system settings like language and brightness.

Set Device Language

Guide to changing the device's display language.

Adjust Screen Brightness

Instructions for adjusting the screen brightness.

System Information and Feedback

How to view device info and manage acoustic feedback.

Acoustic Feedback Settings

How to enable or disable audio signals for treatment completion.

Buzzer and Maintenance Settings

Adjusting buzzer tones/duration and accessing maintenance functions.

Manual Operation (Type 1)

Step-by-step guide for manual operation on Type 1.

Clinical Protocols Overview

How to select and view pre-set clinical protocols.

Protocol Information Screen

Details the information displayed for each protocol.

4P Isoplanar Vector Parameters

Parameter screen overview and intensity adjustment for 4P Isoplanar Vector.

Manual Operation (Types 2 & 3)

Guide to manual operation for Types 2 and 3.

Setting Frequency Parameters

How to set frequency parameters for different wave forms.

Setting Burst Frequency

Adjusting burst frequency for Burst TENS.

Setting Modulation Frequency

Adjusting modulation frequency for TENS.

Setting Modulation Time

Setting modulation time parameters.

Setting Treatment Time

Adjusting the duration of the treatment.

Vacuum Module Settings

Using and setting parameters for the vacuum module.

Setting Intensity Parameters

Adjusting intensity levels for various modes.

Setting Balance Control

Adjusting intensity balance between channels for 4P Interferential.

Setting Vector View

Viewing vector animation during 4P Isoplanar Vector treatment.

Saving Favorites

Saving and managing custom treatment settings.

Loading and Deleting Favorites

Procedures for loading and removing saved favorite settings.

11 Application Information

Electrode Connection (Type 1)

Guides on connecting electrodes for Endomed 182 Type 1.

Electrode Connection (Type 2)

Connecting patient cables for Endomed 182 Type 2.

Electrode Connection (Type 3)

Connecting patient cables for Endomed 182 Type 3.

General Treatment Procedures

General procedures before, during, and after treatment.

Percutaneous Electrolysis (Type 1)

Information specific to PE treatment using Type 1.

Acupuncture Needle Usage

Details on selecting and using acupuncture needles.

Foot Switch Operation

Instructions for connecting and using the optional foot switch.

TENS/IFC Application (Types 2 & 3)

Protocols for safe application and termination of TENS/IFC.

Flexible Rubber Electrode Usage

Guidelines for using flexible rubber electrodes and sponge pads.

Self-Adhesive Electrode Precautions

Precautions and usage guidelines for self-adhesive electrodes.

Vacuum Electrode Application (Type 3)

Instructions for using vacuum electrodes with Type 3.

Continuous vs. Pulsed Vacuum

Explains continuous and pulsed vacuum modes.

Current Density Guidelines

Recommended limits and calculations for current density.

Connection/Disconnection Reactions

Potential reactions during electrode connection/disconnection.

12 Maintenance and Troubleshooting

General Cleaning and Disinfection

General guidelines for cleaning device components and accessories.

Cleaning the Device

Cleaning instructions for the main device unit.

Cleaning the Display Panel

Specific instructions for cleaning the device's display panel.

Cleaning Accessories

Cleaning procedures for various accessories.

Cleaning Cables and Reservoir

Cleaning instructions for cables, reservoir, and hoses.

Troubleshooting Overview

General troubleshooting guidance for device issues.

Error Message Handling

Explains device error messages and initial response.

Device Cooling and Output Issues

Addresses overheating and lack of output current problems.

Water Reservoir and Vacuum Leak Issues

Troubleshooting for full reservoir and vacuum leaks.

Technical Maintenance Procedures

Guidelines for authorized maintenance and service.

Expected Service Life and Disposal

Information on device service life and end-of-life disposal.

13 Specifications

General Technical Data

Lists electrical, dimensional, and weight specifications.

Type 1 Specifications

Detailed specifications for Endomed 182 Type 1.

Types 2 & 3 Specifications

Detailed specifications for Endomed 182 Types 2 and 3.

2-Pole Interferential Specs

Technical specifications for 2-pole interferential mode.

4-Pole IFC & Isoplanar Vector Specs

Technical specifications for 4-pole IFC and Isoplanar Vector.

TENS Specifications

Technical specifications for TENS current.

Safety and Performance Standards

Details medical device classification and safety standards.

Essential Performance Requirements

Outlines the essential performance requirements of the device.

Environmental Conditions

Specifies temperature, humidity, and pressure for storage and use.

Electromagnetic Compatibility (EMC)

Information regarding electromagnetic compatibility of the device.

14 Contact

Support and Contact Information

Provides website, telephone, and contact details for support.

15 Product Liability

Product Liability Information

Legal information regarding product liability and warranty.

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