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Synthes MAXFRAME AUTOSTRUT - User Manual

Synthes MAXFRAME AUTOSTRUT
64 pages
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MAXFRAME AUTOSTRUT
Multi-Axial Correction System
Physician User Manual

Other manuals for Synthes MAXFRAME AUTOSTRUT

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Summary

Welcome

About this Document

Introduces the MAXFRAME AUTOSTRUT System, its hardware, software, and procedures.

Notes and Precaution Statements

Explains the use of notes and precaution statements for safety and effective device use.

Information Security

Details information security measures for the MAXFRAME AUTOSTRUT System.

Introduction to MAXFRAME AUTOSTRUT System

System Features and Benefits

Describes the hardware and software components and benefits of the MAXFRAME AUTOSTRUT System.

Indications and Contraindications for Use

Lists medical conditions for use and situations where the system should not be used.

General Warnings and Restrictions

Provides essential safety warnings, precautions, and usage restrictions for the system.

MRI Safety and Software Requirements

Details MRI precautions and the necessary hardware/OS for the software.

Product Description and Components

Hardware Components Overview

Describes the hardware components, including struts and the control system.

Struts Specifications

Details the MAXFRAME AUTOSTRUT hexapod struts, including sizes and specifications.

Control System Details

Explains the MAXFRAME AUTOSTRUT Control System components and kit contents.

Instruments and Software Functions

Lists instruments used and describes the functions of the MAXFRAME AUTOSTRUT Software.

Surgical Technique and Procedures

Frame Assembly and Strut Attachment

Step-by-step instructions for assembling the frame and attaching struts to the patient.

Control System Assembly and Plan Download

Instructions for assembling the control system and downloading the treatment plan.

Treatment Plan Upload and Verification

Uploading, verifying, and approving patient treatment plans and strut movements.

Starting, Managing, and Replanning Treatment

Procedures for starting treatment, disconnecting, and replanning with manual adjustments.

Manual Mode and Log;Status Functions

Using manual mode and accessing log and status information for system monitoring.

Patient Instruction and Emergency Stop Usage

Instructing patients, explaining LED indicators, and using the emergency stop button.

Troubleshooting and Strut Length Adjustments

Guidance on troubleshooting errors and performing strut length changes.

Control System and Motor Dismantling

Steps for dismantling the control system and motors after treatment completion.

Care and Maintenance

Cleaning and Sterilization Procedures

Guidelines for cleaning, disinfecting, and maintaining system components.

Software Updates and Patches

Manufacturer Software Updates

Information on manufacturer-released software updates and patches for the system.

Symbols Glossary

Device and Safety Symbols

Explanation of symbols used in the manual and on the device for identification and safety.

Additional Symbol Definitions

Further definitions of symbols related to usage, sterilization, and disposal.

Specifications

Dimensions, Weight, and Environmental Conditions

Details on component dimensions, weight, storage, and operating conditions.

Electromagnetic Compatibility Declarations

Manufacturer's declarations and guidance on electromagnetic emissions and immunity.

RF Equipment Separation Distances

Tables specifying recommended separation distances for RF communications equipment.

Product Information

Component Part Numbers and Descriptions

Lists part numbers and corresponding descriptions for system components.

Standards and Compliance for EMC

EMC Standards and Regulations

Information on compliance with international and national EMC standards and regulations.

Synthes MAXFRAME AUTOSTRUT Specifications

General IconGeneral
CategoryMedical Equipment
ManufacturerSynthes
Product NameMAXFRAME AUTOSTRUT
TypeExternal Fixation System
ApplicationUsed for limb lengthening, deformity correction, and fracture fixation.
MaterialStainless Steel
CompatibilitySynthes MAXFRAME system
SterilityNon-sterile (supplied non-sterile, requires sterilization before use)
WeightVaries depending on size and material

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