EMSI FLEX-MT PLUS - User Manual

Instruction Manual
Please read the Instruction
Manual prior to use.
CAUTION: Federal law requires a prescription from your physician before use of this product.

Summary

Intended Use

TENS Applications

Symptomatic relief of chronic pain and post-traumatic/surgical pain.

EMS Applications

Muscle spasm relaxation, circulation, re-education, atrophy prevention.

Patient Guidance

Pre-use Patient Guidance

Read manual, follow instructions, consult clinician for questions.

Contraindications

Specific Contraindications

Lists electrode placement for carotid sinus, transcerebral, pacemaker users, and undiagnosed pain.

Warnings

Warnings on Stimulation Application

Avoid carotid sinus, neck, mouth, trans-thoracic areas, and infected/inflamed regions.

Usage and Safety Warnings

External use, eye area, pregnancy, driving, children, central pain, ECG interference, symptomatic treatment.

Precautions

Precautions for Heart and Epilepsy Patients

Caution advised for patients with suspected heart problems or epilepsy.

Precautions for Specific Conditions

Caution during hemorrhage tendency, post-surgery, menstruation/pregnancy, or altered sensation.

Adverse Reactions

Skin Irritation and Allergic Reactions

Possible skin irritation, electrode burn, or allergic reaction to tape/gel.

Electromagnetic Disturbances

Potential interference from high-frequency transmitters and resulting risks.

Unit Description

Unit Controls Overview

Descriptions of ON/OFF, MODE, SET, TIMER, INCREASE/DECREASE, LOCK/UNLOCK buttons.

Unit Description Continued

LCD Display and Indicators

Explanation of TENS & EMS Mode Area, parameters, battery indicator, etc.

Accessories

Details on electrode leadwires and battery charger specifications.

Specifications

EMS;TENS Performance Specifications

Details on channel output, waveform, pulse width, pulse frequency, and EMS timings.

Specifications Continued

Operational and Physical Specifications

Specifications for ramp, compliance timer, ambient conditions, size, and weight.

TENS Mode Overview

Introduction to TENS modes, advising to set intensity to minimum first.

TENS Stimulation Modes

Burst Mode Description

Describes the burst mode with seven pulses delivered per second at fixed 100Hz.

Normal Mode Description

Describes continuous train of impulses with adjustable rate and width.

Modulated Rate & Width (MRW) Mode

Describes automatic variation of rate and width for massage-like sensation.

TENS Stimulation Modes Continued

Modulated Intensity & Pulse Width (SD) Mode

Alternating modulated intensity and pulse width, 6-second cycle.

Bi-Pulse (Bi-Pulse) Mode

Delivers 4 pulses/sec on Channel 1, 100 pulses/sec on Channel 2, 1-sec burst.

EMS Treatment Functions Descriptions

EMS Alternative (A) Mode

Channels 1 and 2 pulses are alternative; one is active while the other is inactive.

EMS Synchronous (S) Mode

Channels 1 and 2 pulses are synchronous; both are activated simultaneously.

Instructions For Use

Battery Check and Charging

Instructions for inserting battery pack and charging the device.

Instructions For Use Continued

Connecting Electrodes and Lead Wires

Instructions for connecting electrodes to lead wires and lead wires to the unit.

Instructions For Use Continued

Electrode Placement and Treatment Protocol

How to place electrodes and follow clinician's treatment directives.

Instructions For Use Continued

Turning Unit Off and Locking Feature

Procedures for turning off the unit and using the locking mechanism.

Special Cares in Operating

General Operating Precautions

Cleanliness, electrode inspection, single-patient use, secure placement, physician sites.

Intensity Adjustment and Interference

Slowly increase intensity, reduce if uncomfortable, caution with electromagnetic interference.

Post-Treatment Procedures

Turn off unit, remove electrodes, conserve battery life.

Instructions For Use Continued

Operation Procedure Chart

Step-by-step chart for operating the Flex-MT Plus device.

Patient Compliance Timer

Recording Individual Treatment Time

How to scroll, delete, and record individual treatment session times.

Patient Compliance Timer Continued

Recording Cumulative Treatment Time

Shifting to cumulative time, deleting records, and battery impact.

Care and Maintenance

Low Battery Indicator and Cleaning

How to identify low battery and clean the unit housing.

Electrode Pad Disposal and Use

Guidelines for when to replace electrodes and their single-use policy.

Care and Maintenance Continued

Ordering Replacement Electrodes

Contact information for ordering replacement electrodes.

Troubleshooting

Troubleshooting Unit Malfunctions

Guide for diagnosing and resolving issues like unit not functioning or battery problems.

Contacting Customer Service

Information on when and how to contact customer service for unresolved issues.

Product Description and Symbols

Manufacturer, single patient use, keep dry, prescription use only symbols.

Declarations-EMC

Electromagnetic Emissions Guidance

Guidance on electromagnetic environment and RF emissions compliance.

Electromagnetic Immunity Guidance

Electromagnetic Immunity - ESD and Transient Protection

Guidance on electrostatic discharge and transient immunity.

Electromagnetic Immunity - Surge Protection

Guidance on surge immunity for power supply lines and earth connections.

Electromagnetic Immunity Guidance Continued

Electromagnetic Immunity - Voltage Variations

Guidance on immunity to voltage dips, interruptions, and variations.

Electromagnetic Immunity - Magnetic Fields

Guidance on immunity to power frequency magnetic fields.

Electromagnetic Immunity Guidance Continued

Electromagnetic Immunity - RF Interference

Guidance on immunity to conducted and radiated RF interference.

RF Separation Distance Guidelines

Recommended separation distances for RF communication equipment.

Recommended Separation Distance for RF Equipment

RF Separation Distance Calculation

Tables and formulas for calculating RF separation distances based on transmitter power.

Waveform Reference

TENS Burst Waveform Reference

Visual reference for Symmetric and Asymmetric Burst waveforms.

TENS Normal Waveform Reference

TENS Normal Waveform Reference

Visual reference for Symmetric and Asymmetric Normal waveforms.

TENS MRW Waveform Reference

TENS MRW Waveform Reference

Visual reference for Symmetric and Asymmetric MRW waveforms.

TENS SD Waveform Reference

TENS SD Waveform Reference

Visual reference for Symmetric and Asymmetric SD waveforms.

TENS Bi-Pulse Waveform Reference

TENS Bi-Pulse Waveform Reference (Channel 1)

Visual reference for Channel 1 Bi-Pulse waveforms.

TENS Bi-Pulse Waveform Reference (Channel 2)

TENS Bi-Pulse Waveform Reference (Channel 2)

Visual reference for Channel 2 Bi-Pulse waveforms.

EMS Alternate Waveform Reference

EMS Alternate (A) Single Pulse Waveform

Visual reference for Alternate (A) Single Pulse waveforms.

EMS Alternate (A) Multi Pulse Waveform

Visual reference for Alternate (A) Multi Pulse waveforms.

EMS Synchronous Waveform Reference

EMS Synchronous (S) Single Pulse Waveform

Visual reference for Synchronous (S) Single Pulse waveforms.

EMS Synchronous (S) Multi Pulse Waveform

Visual reference for Synchronous (S) Multi Pulse waveforms.

Warranty

EMSI FLEX-MT PLUS Specifications

General

Category	Fitness Equipment
Programs	Multiple pre-set programs
Intensity Levels	Adjustable
Battery	Rechargeable
Portability	Portable