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MTS Systems OrthoGold100 OW100-US User Manual

MTS Systems OrthoGold100 OW100-US
70 pages
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1 MTS_OW100_IFU-orthogold100-US-K182682_A
Instructions for Use
OrthoGold100
®
Model: OW100-US
(US-510K, K182682)
Revision A, 2019-01-09
Caution: Federal law restricts this device to sale by or on the order of a physician.

Table of Contents

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MTS Systems OrthoGold100 OW100-US Specifications

General IconGeneral
CategoryMedical Equipment
ModelOrthoGold100 OW100-US
ManufacturerMTS Systems
Control ModesForce, Displacement, Strain
Data AcquisitionHigh-speed data acquisition system
SoftwareTestSuite TW software

Summary

Introduction

Device Information

Indications and Contraindications

Specifies the intended purpose and lists situations where the OrthoGold100® device should not be used.

Device Warnings and Cautions

Highlights critical safety warnings and potential hazards or minor injuries associated with device use.

Device Description

Provides an overview of the OrthoGold100® device, its function, and its main components.

Set-up Instructions

Unpacking and Power Connection

Guides on unpacking, placing the device, and connecting the power supply for initial operation.

Applicator and Water Cartridge Setup

Instructions for connecting the applicator and managing the water cartridge for device operation.

Footswitch and Menu Configuration

Steps to connect the footswitch and configure device settings via the menu.

Operating Instructions

General Operational Safety

Important safety instructions to follow before and during device operation.

Setting Output Parameters

Guide on adjusting treatment parameters like energy, frequency, and pulse numbers using the touch panel/wheel.

Acoustic Wave Treatment Procedure

Steps and considerations for performing acoustic wave treatment on a patient.

Emergency Procedures

Cleaning and Maintenance

Cleaning the Device and Applicator

Procedures for cleaning and disinfecting the main device and its applicator after use.

Scheduled Maintenance and Service

Information regarding regular maintenance, inspections, and authorized service personnel.

Technical Specifications and EMC

Electrical and EMC Compliance

Details on electrical safety, electromagnetic compatibility, and regulatory compliance.

Electromagnetic Interference Management

Recommended safety distances and precautions related to mobile HF telecommunication devices.

Emissions and Immunity Standards

Manufacturer's declaration on electromagnetic emissions and immunity based on standards.

Troubleshooting

Error Analysis and Troubleshooting Table

Table listing common device errors, their reasons, and recommended actions.

Understanding Error Message Types

Explanation of different types of error messages (fatal, warning, information) with codes.

Additional Information

Ordering and Support Contacts

Contact details for ordering consumables, accessories, spare parts, and service.

Product Liability and Warranty Details

Information regarding manufacturer liability and warranty terms and conditions.

Transport and Return for Service

Guidelines for transporting the device internally, externally, and for service returns.

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