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Chattanooga USA
2020 VitalStim® Plus

2020 VitalStim® Plus

Product catalog summary

Introduction
The manual provides detailed guidance on the operation, safety practices, and maintenance of the VitalStim® Plus Electrotherapy System. Users are encouraged to read the manual thoroughly to enhance the system's efficiency and longevity. Specifications may change due to ongoing improvements.

Precautionary Instructions
Safety indicators such as 'NOTE', 'CAUTION', 'WARNING', and 'DANGER' are used to highlight potential safety issues ranging from minor injuries to serious hazards.

Device Description
The VitalStim® Plus is a four-channel electrotherapy system designed for muscle re-education and relaxation of muscle spasms, particularly in treating swallowing dysfunctions. It features sEMG biofeedback and VMS waveform applications.

Indications for Use
The device is intended for muscle re-education and relaxation of muscle spasms in the face and neck muscles, particularly for treating dysphagia. It should not be used on patients with cancerous lesions, over inflamed areas, or with certain medical conditions like severe dementia or significant reflux.

Contraindications
Contraindications include use over cancerous lesions, infected areas, or in patients with cardiac pacemakers. It is also not recommended for use during pregnancy or in patients with undiagnosed syndromes.

System Specifications
The manual details the system's specifications, including power requirements and waveform characteristics, ensuring users understand the technical aspects of the device.

Patient Preparation
Guidelines for electrode placement and patient preparation are provided to ensure effective and safe treatment.

Device User Interface
The user interface section describes the screen layout and navigation, including treatment screens and utilities.

Maintenance
Instructions for cleaning, calibration, and software upgrades are included to maintain the device's functionality and compliance with safety standards.

Service and Warranty
Information on warranty coverage and repair services is provided to assist users in case of device malfunction.

Specifications
The document outlines the specifications for the VitalStim® Plus Electrotherapy System, including various modes and settings for electrotherapy and sEMG. Key specifications include output intensity, channel modes, phase duration, frequency, ramp up/down time, treatment time, sEMG range, and sensitivity.

Procedures
Detailed procedures for patient preparation and device operation are provided, including skin examination and cleaning, electrode application, and sEMG operation.

Device User Interface
The user interface includes screens and icons for managing treatment settings, such as home screen access, utilities, and treatment screens.

Electrode Placement
Guidelines for electrode placement include applying electrodes to appropriate skin areas, attaching lead wire strain relief clips, and ensuring single patient use.

Recommendations
Recommendations for effective use include cleaning the treatment area, using electrode placement guidelines, and customizing waveform settings as needed.

VitalStim® Plus Electrotherapy System Overview
The system is designed for muscle retraining through sEMG biofeedback and electrical muscle stimulation, with options for setting targets and conducting swallow trials.

Data Management
Patient treatment data can be saved to a Micro SD Card or exported to a PC, with options for viewing and accessing patient data.

Resource Library
The device includes a Resource Library with anatomical images and tutorial videos to aid in understanding muscle groups and treatment procedures.

Accessories
The system comes with various accessories, including electrodes and lead wires, with options for replacement and additional accessories.

Cleaning and Maintenance
The device should be cleaned with a lint-free cloth moistened with water and mild antibacterial soap. It should not be submerged in liquids.

Device Lifespan and Disposal
The device is expected to last at least five years, with disposal complying with the Council Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE).

Software Upgrade Instructions
Instructions for upgrading the software using a Micro SD card are provided.

Service and Warranty
Contact information for service and warranty coverage is provided, with repairs to be performed by authorized service centers.

Electromagnetic Compatibility (EMC)
The device complies with IEC 60601-1-2 EMC limits for medical devices, with guidelines for managing the electromagnetic environment.

FCC Requirements
The device complies with Part 15 of the FCC Rules, with conditions for operation and the FCC ID provided.

Manufacturer Information
The device is manufactured by DJO, LLC, with contact information and product identification details provided.

Catalog excerpts

VitalStim® Plus Four Channel Electrotherapy System User Manual Operator and Installation Instructions

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VitalStim® Plus Electrotherapy System TABLE OF CONTENTS INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 FORWARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 PRECAUTIONARY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . 2 GENERAL TERMINOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SYSTEM SOFTWARE SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . 3 DEVICE MARKINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . ....

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VitalStim® Plus Electrotherapy System PRECAUTIONARY INSTRUCTIONS This manual is intended for users of VitalStim® Plus Electrotherapy System. It contains general information on operation, precautionary practices, and maintenance. In order to maximize use, efficiency, and the life of the system, please read this manual thoroughly and become familiar with the controls, as well as the accessories before operating the system. The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating...

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VitalStim® Plus Electrotherapy System GENERAL TERMINOLOGY The following are definitions for the terminology used throughout this manual. Study these terms to become familiar with them for ease of system operation and control functionality of the VitalStim® Plus Electrotherapy System. SYSTEM SOFTWARE SYMBOLS Back Arrow/Previous Screen Forward Arrow/ Next Screen sEMG Increase/Decrease Parameter sEMG+VMS Electrode Placement Scroll Up or Down in a text box Modality Description Select Custom Protocols Patient Data Micro SD Card indicator Anatomical Library Hand switch indicator Battery voltage level...

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VitalStim® Plus Electrotherapy System DESCRIPTION OF DEVICE MARKINGS The markings on the unit are assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility. One or more of the following markings may appear on the device: Refer to Instructional Manual Booklet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Neuromuscular Stimulation (STIM) and sEMG +Stimulation should not be used by Patients fitted with demand style cardiac pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....

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VitalStim® Plus Electrotherapy System ELECTROTHERAPY, sEMG+VMS INDICATIONS Indications The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle reeducation. For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation. • Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Intended Uses- VMS™ Waveform This device should not be used when cancerous lesions are present in the treatment area. VMS waveform is a square symmetrical biphasic waveform with the application for use on the musculature of...

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VitalStim® Plus Electrotherapy System Additional Precautions • Caution should be used for patients with suspected or diagnosed epilepsy Caution should be used for patients with suspected or diagnosed heart problems Caution should be used in the presence of the following: - When there is a tendency to hemorrhage following acute trauma or fracture - Following recent surgical procedures when muscle contraction may disrupt the healing process - Over areas of the skin that lack normal sensation • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or...

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DEVICE DESCRIPTION VitalStim® Plus Electrotherapy System PRODUCT DESCRIPTION The VitalStim® Plus Electrotherapy System is a 2 Channel sEMG and 4 Channel electrotherapy system used in treating patients with oral-pharyngeal dysfunctions (dysphagia) and disorders of the head and neck, with Bluetooth connection to PC software. To maximize functionality and life of VitalStim® Plus Electrotherapy System, be sure to: • Stay current with the latest clinical developments in the field of electrotherapy, sEMG (Surface Electromyography), sEMG + Stim (Surface Electromyography with Triggered Stimulation) and...

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DEVICE DESCRIPTION VitalStim® Plus Electrotherapy System OPERATOR INTERFACE Front Controls VitalStim® Plus Electrotherapy System Operator Interface contains all the functions and controls necessary for operator access to all operator utilities, modalities, and parameters for modification and system set up. 1. Color Display 2. BACK button 3. HOME button 4. Clinical Resource Library button 6. STOP button 7. START/PAUSE button 9. Ch3 Lead Wire Connector (STIM) 10. Ch4 Lead Wire Connector (STIM) 11. Operator Remote Switch Connector Front Panel and Battery Compartment 12. Ch2 Lead Wire Connector (sEMG...

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GENERAL WARNINGS AND PRECAUTIONS VitalStim® Plus Electrotherapy System • Read, understand, and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation. Observe the precautionary and operational decals placed on the unit. • Inspect lead wires and associated connectors for signs of damage before each use. Replace damaged lead wires immediately with new before any treatment is applied. • Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner or other licensed health...

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GENERAL WARNINGS AND PRECAUTIONS VitalStim® Plus Electrotherapy System WARNING • Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. • Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the application of each mode of treatment. • Simultaneous connection of a patient to high frequency surgical equipment...

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