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Performance Health Performa Combin8 Quattro - User Manual

Performance Health Performa Combin8 Quattro
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Performa Professional Series
Performa
Professional Series
InTENSity Professional Series
USER MANUAL
Operation Instructions For:
Performa
Combin8 Quattro
Performa
Combin8 Duo
Performa
Stimul8
Performa
Gener8

Table of Contents

Questions and Answers

Summary

User Manual Scope and Compliance

Manual Validity Statement

Confirms manual applies to Performa™ Professional Series devices.

Safety Standards Conformity

Details compliance with normative documents and directives.

Introduction and Safety

Intended User and Purpose

Defines target users and manual's scope for Performa™ devices.

Safety Precautions and Symbols

Highlights essential safety warnings and explains hazard symbols.

Device Safety Precautions

Contraindicated Device Combinations

Lists medical devices incompatible with the Performa™ Professional Series.

Conditions for Non-Use

Specifies conditions where the device must not be used to prevent harm.

Electrotherapy Safety: Individuals and Electrodes

Contraindicated Individuals

Lists patient groups for whom electrotherapy is not advised.

Electrode Application and Usage

Guides on proper electrode placement, handling, and prohibited usage.

General, Electrotherapy, and Ultrasound Warnings

General Device Operation Warnings

Covers electrical safety, environment, and user responsibilities.

Electrotherapy Specific Warnings

Addresses TENS, pregnancy, and specific skin conditions.

Ultrasound Specific Warnings

Details precautions for ultrasound on specific patients and thermal risks.

Ultrasound Precautions and Stimulator Cautions

Ultrasound Application Techniques

Advises on applicator movement and heating of joint capsules.

Ultrasound Contraindicated Conditions

Lists patient conditions requiring extra caution with ultrasound.

Stimulator Usage Cautions

Cautions on device operation, interference, and electrode care.

General Device Cautions and Precautions

Stimulator Usage and Interference

Cautions on equipment inspection, placement, and potential interference.

General Operational Precautions

Covers long-term effects, skin application, and patient conditions.

Child Safety and Electrode Quality

Advises on keeping unit from children and using clinical grade electrodes.

Intended Use: Electrotherapy

Electrotherapy Indications

Lists conditions for which electrotherapy waveforms are indicated.

Electrotherapy Contraindications

Details contraindications for electrotherapy, including pacemakers and specific body areas.

Intended Use: Ultrasound Therapy

Ultrasound Indications

Lists conditions for which ultrasound therapy is indicated.

Ultrasound Contraindications

Details contraindications for ultrasound, including pregnancy, malignancy, and specific body areas.

Adverse Effects and Parameters

Ultrasound Application Effects

Covers applicator movement, potential adverse effects, patient susceptibility, and coupling.

Parameter Definitions

Defines common electrotherapy parameters like C.C., C.V., F.M., etc.

Waveform Specifications: Interferential Current (IFC)

IFC Traditional (4 Pole) Overview

Explains IFC traditional waveform, its application, and electrode setup.

IFC Parameters and Output

Details parameters and output settings for IFC Traditional.

Waveform Specifications: Premodulated IFC

Premodulated IFC (2 Pole) Overview

Describes premodulated IFC waveform, its bipolar technique, and application.

Premodulated IFC Parameters and Output

Details parameters and output settings for Premodulated IFC.

Waveform Specifications: Biphasic (TENS)

TENS Biphasic Waveform Description

Explains Asymmetrical and Symmetrical Biphasic waveforms used in TENS.

TENS Parameters and Output

Details parameters and output settings for TENS.

Waveform Specifications: Biphasic (RAAS)

RAAS Biphasic Waveform Description

Describes RAAS biphasic waveform for muscle firing patterns and neuromuscular reeducation.

RAAS Parameters and Output

Details parameters and output settings for RAAS.

Waveform Specifications: Russian Stimulation

Russian Stimulation Description

Explains Russian Current waveform for muscle strengthening without significant discomfort.

Russian Parameters and Output

Details parameters and output settings for Russian Stimulation.

Waveform Specifications: High Volt

High Volt Waveform Description

Describes High Volt waveform, its characteristics, and effects.

High Volt Parameters and Output

Details parameters and output settings for High Volt.

High Volt Application Note

Advises on using specific dispersive electrode size for High Volt therapy.

Waveform Specifications: Microcurrent

Microcurrent Waveform Description

Explains Microcurrent waveform, its low intensity, and potential benefits for healing.

Microcurrent Parameters and Output

Details parameters and output settings for Microcurrent.

Waveform Specifications: NMS

NMS Waveform Description

Describes NMS waveform, its suitability for high intensities and muscle strengthening.

NMS Parameters and Output

Details parameters and output settings for NMS.

Waveform Specifications: Ultrasound Therapy

Ultrasound Therapy Parameters

Details ultrasound parameters like Frequency, Duty Cycle, ERA, Amplitude.

Ultrasound Output Power and Applicator Specs

Lists output power, duty factors, accuracy, and applicator specs.

Ultrasound Specifications and Connectivity

Ultrasound Parameter Limits

Defines limits for electrotherapy intensity based on frequency and pulse duration.

Technical and Environmental Data

Lists technical specs like Power Supply, Dimensions, Temperature, Humidity.

Power Connection and Disconnection

Details how to connect to AC power and disconnect the device safely.

Package Contents

Performa Stimul8 Contents

Lists items included with the Performa™ Stimul8 device.

Performa Combin8 Quattro Contents

Lists items included with the Performa™ Combin8 Quattro device.

Optional Accessories

Lists optional accessories available for the Performa™ Series.

Package Contents: Gener8 and Combin8 Duo

Performa Gener8 Contents

Lists items included with the Performa™ Gener8 device.

Performa Combin8 Duo Contents

Lists items included with the Performa™ Combin8 Duo device.

Operating Controls: Performa Stimul8

Stimul8 Front Panel Controls

Identifies and describes the front panel controls and indicators of the Performa™ Stimul8.

Operating Controls: Stimul8 Rear and Symbols

Stimul8 Rear Panel Controls

Identifies and describes the rear panel controls and connections of the Performa™ Stimul8.

Device Symbols Guide

Explains common symbols used on the device and in the manual.

Operating Controls: Performa Combin8 Quattro

Combin8 Quattro Front Panel Controls

Identifies and describes the front panel controls and indicators of the Performa™ Combin8 Quattro.

Operating Controls: Combin8 Quattro Rear and Symbols

Combin8 Quattro Rear Panel Controls

Identifies and describes the rear panel controls and connections of the Performa™ Combin8 Quattro.

Device Symbols Guide

Explains common symbols used on the device and in the manual.

Operating Controls: Performa Combin8 Duo

Combin8 Duo Front Panel Controls

Identifies and describes the front panel controls and indicators of the Performa™ Combin8 Duo.

Operating Controls: Combin8 Duo Rear and Symbols

Combin8 Duo Rear Panel Controls

Identifies and describes the rear panel controls and connections of the Performa™ Combin8 Duo.

Device Symbols Guide

Explains common symbols used on the device and in the manual.

Operating Controls: Performa Gener8

Gener8 Front Panel Controls

Identifies and describes the front panel controls and indicators of the Performa™ Gener8.

Operating Controls: Gener8 Rear and Symbols

Gener8 Rear Panel Controls

Identifies and describes the rear panel controls and connections of the Performa™ Gener8.

Device Symbols Guide

Explains common symbols used on the device and in the manual.

Product Description: Performa Series Overview

Performa Stimul8 Description

Describes the Stimul8 device, its electrotherapy channels, and waveforms.

Performa Combin8 Quattro Description

Describes the Combin8 Quattro as a combination therapy device.

Performa Combin8 Duo Description

Describes the Combin8 Duo as a 2-channel combination device.

Performa Gener8 Description

Describes the Gener8 as a dual sound head ultrasound device.

Device Interface: Home and Therapy Displays

Home Screen Navigation

Explains how to navigate the Home Menu and access device functions.

Main Therapy Display Structure

Describes the main therapy display sections: Navigation, Parameters, Channel Info.

Touchscreen Navigation and Electrotherapy Screen

Navigation Bar Functions

Details the functions of icons in the touchscreen navigation bar.

Electrotherapy Treatment Screen Elements

Identifies elements on the electrotherapy treatment screen for Stimul8/Combin8.

Treatment Screens: Ultrasound and Combination

Ultrasound Treatment Screen Elements

Identifies elements on the ultrasound treatment screen for Gener8/Combin8.

Combination Therapy Screen Elements

Identifies elements on the combination therapy screen for Combin8 Quattro/Duo.

Application Information: Electrotherapy

Electrotherapy Cautions and Best Practices

Cautions on accessories, broken skin, and electrode usage.

Electrotherapy Pre-Treatment Steps

Steps before starting electrotherapy: check contraindications, test warmth, clean area.

Self-Adhesive Electrodes for Electrotherapy

Information on self-adhesive electrodes, impedance, and DC component use.

Electrode Connection;Disconnection Reactions

Warns about potential reactions during electrode connection/disconnection.

Navigation: Electrotherapy Setup - Clinical Protocols

Accessing Electrotherapy from Home Menu

How to access electrotherapy functions from the Home Menu.

Selecting Clinical Protocols

Steps to select and view information on clinical protocols for electrotherapy.

Navigation: Electrotherapy - Parameters and Start

Electrotherapy Channel Selection

Guides on selecting channels for electrotherapy treatment.

Adjusting Electrotherapy Parameters

How to adjust treatment parameters using the central control dial.

Electrotherapy Time Adjustment

How to adjust the treatment time for electrotherapy.

Starting Electrotherapy Treatment

Steps to start and adjust output level for electrotherapy treatment.

Navigation: Managing Electrotherapy Treatments

Pausing, Continuing, and Stopping Therapy

Instructions on pausing, continuing, and stopping electrotherapy treatment.

Storing Favorite Electrotherapy Settings

How to save and name favorite treatment settings.

Navigation: Electrotherapy - Manual Operation

Accessing Manual Operation

How to access manual operation for electrotherapy from the menu.

Selecting Waveform in Manual Mode

Guides on selecting the desired electrotherapy current waveform.

Manual Channel Selection

Steps for selecting channels in manual electrotherapy operation.

Adjusting Manual Parameters

How to adjust parameters in manual electrotherapy mode.

Navigation: Managing Manual Electrotherapy

Manual Treatment Time Adjustment

How to adjust treatment time in manual electrotherapy mode.

Starting Manual Electrotherapy Treatment

Steps to start and adjust output for manual electrotherapy treatment.

Storing Favorite Manual Settings

How to save and name favorite settings in manual electrotherapy mode.

Application Information: Ultrasound Therapy

Ultrasound Contact Control Function

Explains the contact control function of the ultrasound applicator.

Ultrasound Contact Medium Requirements

Discusses the importance and types of contact mediums for ultrasound transfer.

Ultrasound Therapy: Pre-Treatment Steps

Steps before starting ultrasound: check contraindications, test warmth, clean area.

Ultrasound Therapy: During Treatment

Guidelines for moving the applicator and patient feedback during ultrasound.

Ultrasound Therapy: Post-Treatment Steps

Steps after completing ultrasound treatment: cleaning and checking effects.

Navigation: Ultrasound Setup - Clinical Protocols

Accessing Ultrasound from Home Menu

How to access ultrasound functions from the Home Menu.

Selecting Ultrasound Clinical Protocols

Steps to select and view information on clinical protocols for ultrasound therapy.

Navigation: Ultrasound - Parameters and Start

Adjusting Ultrasound Parameters

How to adjust ultrasound treatment parameters using the central control dial.

Ultrasound Time Adjustment

How to adjust the treatment time for ultrasound therapy.

Starting Ultrasound Therapy

Steps to start and adjust output level for ultrasound treatment.

Navigation: Managing Ultrasound Treatments

Storing Favorite Ultrasound Settings

How to save and name favorite ultrasound treatment settings.

Accessing Ultrasound Manual Operation

How to access manual operation for ultrasound from the menu.

Ultrasound Manual Operation Steps

Guides on selecting manual operation for ultrasound therapy.

Navigation: Managing Manual Ultrasound

Manual Ultrasound Parameter Adjustment

How to adjust parameters in manual ultrasound mode.

Manual Ultrasound Time Adjustment

How to adjust treatment time in manual ultrasound mode.

Starting Manual Ultrasound Treatment

Steps to start and adjust output for manual ultrasound treatment.

Navigation: Combination Therapy Setup

Combination Therapy Prerequisites

Notes on using the correct lead wire for combination therapy.

Accessing Combination Therapy from Home

How to access combination therapy functions from the Home Menu.

Combination Therapy Manual Operation

Steps to access manual operation for combination therapy.

Setting Combination Electrotherapy Parameters

How to set electrotherapy parameters for combination therapy.

Combination Therapy Time;Parameter Adjustment

How to adjust time and parameters for combination therapy.

Navigation: Managing Combination Therapy

Setting Combination Ultrasound Parameters

How to set ultrasound parameters for combination therapy.

Combination Therapy Time Adjustment

How to adjust treatment time in combination therapy mode.

Storing Favorite Combination Settings

How to save and name favorite combination therapy settings.

Operating Details: System Settings

Accessing System Settings

How to access system settings from the Home Menu.

Personalizing Unit Settings

How to adjust various settings like language, brightness, and volume.

Adjusting Current Amplitude

Explains how current amplitude is displayed and adjusted.

CC;CV Mode Explanation

Describes Constant Current and Constant Voltage modes for electrotherapy channels.

Understanding Current Polarity

Explains current polarity for monophasic currents.

Maintenance: Device and Electrode Care

Device Cleaning Procedures

Instructions for cleaning the main device unit safely.

Display Panel Cleaning Guidelines

Guidelines for cleaning the device's display panel.

Electrode Care and Storage

Advice on electrode lifespan, cleaning, and proper storage.

Maintenance: Cable and Applicator Cleaning

Lead Wires and Cables Cleaning

Instructions for cleaning lead wires and cables, warning against alcohol use.

Ultrasound Applicator Cleaning

Guidelines for cleaning and disinfecting the ultrasound applicator and cable.

Troubleshooting: Error Codes

Troubleshooting Error Codes 101-119

Lists error codes for electrode, applicator, and self-check issues.

Troubleshooting Error Codes 120-128

Lists error codes for storage, password, screen, and ultrasound head issues.

Troubleshooting: Technical Maintenance

Electrical Safety and Servicing

Emphasizes electrical safety and annual servicing by authorized personnel.

Maintenance Warnings

Warns against disassembling the unit and unauthorized maintenance.

Common Device Problems and Solutions

Provides solutions for display failure, weak stimulation, and stimulation stopping.

Troubleshooting: Stimulation Issues and Disposal

Addressing Stimulation Discomfort

Solutions for uncomfortable stimulation, like intensity adjustment and electrode placement.

Addressing Ineffective Stimulation

Solutions for ineffective stimulation, like electrode issues and improper settings.

Device Disposal and Recycling

Advises on recycling materials and following local regulations for waste management.

Safety and Performance Standards Compliance

Compliance with IEC Standards

Lists compliance with IEC 60601-1, IEC 60601-2-5, and IEC 60601-2-10 standards.

Medical Device Classification Standards

States compliance with 21 CFR 1050.10 and 21 CFR 898 regulations.

Electromagnetic Compatibility (EMC) Details

EMC Precautions for Medical Devices

Advises on precautions for EMC and installation of Performa™ Professional Series devices.

RF Communication System Interference

Warns about potential interference from portable RF communication systems.

Electromagnetic Interference Guidelines

Provides guidelines on conformity and expected electromagnetic environment for RF emissions.

Electromagnetic Immunity Guidance

Provides guidance on immunity tests and the electromagnetic environment for device operation.

EMC: Immunity and Separation Distances

Immunity Test Levels and Compliance

Details immunity test levels for conducted and radiated RF disturbances.

Recommended Separation Distances for RF

Provides recommended separation distances for portable/mobile RF telecommunications devices.

EMC: RF Separation Distance Calculations

Fixed Transmitter Field Strength Assessment

Discusses assessing field strength from fixed transmitters and site surveys.

Portable RF Telecommunications Separation Table

Table showing separation distances based on transmitter output power and frequency.

Warranty Information and Claims

Warranty Claim Procedure

Instructions on how to make a warranty claim, including required documentation.

Warranty Coverage and Period

Details warranty terms, replacement options, and the three-year period.

Warranty Exclusions and Limitations

Lists conditions that void the warranty, such as improper treatment or damage.

Performance Health Performa Combin8 Quattro Specifications

General IconGeneral
CategoryMedical Equipment
ManufacturerPerformance Health
ModelPerforma Combin8 Quattro
Channels4
DisplayLCD
TherapiesTENS, EMS

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