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Enraf Nonius ENDOMED 484 User Manual

Enraf Nonius ENDOMED 484
56 pages
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EN109-1498740-40 IFU
ENDOMED 484
EN109-1498740-40 IFU
August 20, 2019
Instructions for use
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Enraf Nonius ENDOMED 484 Specifications

General IconGeneral
CategoryMedical Equipment
TypeElectrotherapy Device
ModelENDOMED 484
ManufacturerEnraf Nonius
DisplayLCD
Pre-programmed protocolsYes
User-defined protocolsYes
ApplicationRehabilitation
Therapy ModesTENS, Interferential, Galvanic
Pulse Width50 - 400 μs
WaveformsRectangular, Triangular, Sinusoidal
ModulationAmplitude, Frequency

Summary

Introduction to Endomed 484

Device Description

Describes the 4-channel electrostimulator for Pain Management (TENS/PENS) and Muscle Stimulation (NMES).

Principles of Operation

Explains the operational principles of TENS, PENS, and NMES, including waveforms and parameters.

Device Markings and Symbols

Device Symbols and Markings

Illustrates and explains various safety, warning, and informational symbols used on the device.

Device Components

Parts Description

Lists and describes the numbered parts of the Endomed 484 device.

Package Contents

Standard and Optional Accessories

Details the standard and optional accessories included with the Endomed 484.

Installation

Inspection and Connection

Procedures for inspecting the device and connecting it to the mains supply.

Battery Installation and Operation

Guides on installing the battery, operating from battery/mains, and disconnection.

Intended Use and User

Intended Use and Applications

Specifies the device's purpose for Pain Management (TENS/PENS) and Muscle Stimulation (NMES).

Intended User Profile

Defines the target users: physical therapy and rehabilitation professionals.

Indications

TENS, PENS, and NMES Indications

Lists medical conditions and symptoms treatable with TENS, PENS, and NMES.

Contraindications and Precautions

TENS/PENS Contraindications and Precautions

Details contraindications, precautions, and warnings for TENS/PENS application.

NMES Contraindications and Precautions

Covers contraindications, precautions, and potential adverse effects for NMES use.

Precautionary Instructions

General Safety and Usage Guidelines

General instructions for safe operation, including supervision and environmental conditions.

Device Operation

Setup and Interface Navigation

Covers device setup, display interface, navigation, and home menu options.

Therapy Modes and Protocols

Explains using clinical protocols and manual operation for therapy.

Parameter Settings and Adjustment

Details how to set and adjust parameters like wave form, frequency, pulse duration, and modulation.

Therapy Management

Guides on setting intensity and starting, pausing, or stopping therapy sessions.

Favorites and Protocols

Instructions for saving, retrieving, and programming multi-step treatment protocols.

System Settings and Shutdown

Covers changing device settings, backing up data, and safe shutdown procedures.

Application Information

Treatment Workflow

Details the step-by-step process from pre-treatment preparation to post-treatment care.

TENS/PENS Application Protocol

Safe application and termination procedures for TENS/PENS therapy.

PENS/Electroacupuncture Safety

Specific safety measures for PENS, including needle securing and lead attachment.

NMES Application Protocol

Safe application and termination procedures for NMES therapy, including risk mitigation.

NMES Electrode Selection and Placement

Guidance on NMES electrode selection, placement, types, and securing.

Electrode Sponges and Current Density

Ensuring proper electrode sponge moistening, securing, and managing current density for safety.

Maintenance and Troubleshooting

Cleaning and Disinfection Procedures

Detailed instructions for cleaning and disinfecting the device, its components, and accessories.

Troubleshooting Common Issues

Guidance on resolving common device errors, warnings, and operational problems.

Device Maintenance and Updates

Covers backing up data, technical servicing, software updates, and device lifecycle.

Specifications

Technical and Electrical Data

Provides detailed electrical, dimension, and technical specifications of the device.

Safety, Environmental, and EMC Standards

Outlines safety standards, essential performance, environmental conditions, and EMC compliance.

Contact and Liability

Contact Information

Provides contact details for assistance and obtaining product documentation.

Product Liability Information

Details product liability laws, limitations on manufacturer responsibility, and user disclaimers.

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