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Otto Bock 757M11 X-Change User Manual

Otto Bock 757M11 X-Change
108 pages
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757M11=X-Change
Gebrauchsanweisung (Fachpersonal) ......................................... 2
Instructions for use (qualified personnel) ...................................... 13
Instructions d'utilisation (Personnel spécialisé) ............................. 25
Istruzioni per l’uso (Personale tecnico specializzato) ..................... 36
Instrucciones de uso (Personal técnico especializado) .................. 48
Gebruiksaanwijzing (Vakmensen) ................................................ 60
Bruksanvisning (Fackpersonal) ................................................... 72
Bruksanvisning (Fagpersonell) ................................................... 83
使用说明书 (专业人员)
............................................................... 94

Table of Contents

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Otto Bock 757M11 X-Change Specifications

General IconGeneral
Model757M11 X-Change
ManufacturerOtto Bock
Maximum Body Weight125 kg
Knee DisarticulationYes
Locking MechanismManual lock
Foot ShellNot applicable
Ankle MobilityNot applicable
Water ResistanceNo
Cosmetic CoverOptional
Product CategoryProsthetic Knee
Flexion Angle150°
FeaturesAdjustable flexion
Product TypeProsthetic Knee
MaterialAluminum

Summary

Product Description and Functionality

Product Design Overview

Describes the physical components of the product, including indicators, displays, and connections.

MyoBoy Operational Functionality

Explains the operational purposes and basic working principles of the MyoBoy, including self-tests and battery status.

Compatible Combination Possibilities

Lists compatible accessories and cables that can be used with the MyoBoy for specific functions.

Intended Use and Qualifications

Indications for Product Application

Specifies the primary applications for the MyoBoy, focusing on prosthetic fitting and use by trained professionals.

Conditions for Proper Product Usage

Details the software and patient types (unilateral/bilateral amputees, dysmelia) compatible with the MyoBoy.

Contraindications for Use

Refers to conditions that contradict or exceed the product's specifications, requiring adherence to safety and usage guidelines.

Required Professional Qualifications

States that product fitting must be performed by an O&P professional, emphasizing qualified personnel.

Safety and Operational Guidance

Understanding Warning Symbols

Defines the meaning of warning symbols like CAUTION and NOTICE used throughout the document for risks and damage.

General Safety Instructions

Provides fundamental safety advice, including observing precautions and averting hazards through specific actions.

Product Manipulation and Repair Restrictions

Warns against unauthorized product manipulation, specifying that only authorized personnel can open or repair it.

Storage and Battery Handling Precautions

Advises removing batteries for long-term storage to prevent skin irritation from leaks or product damage.

Accessory and Environmental Usage Warnings

Warns about using unapproved accessories and the risks of dirt and humidity ingress for product malfunction.

Operational Environment and Interference

Warns against mechanical stress, extreme temperatures, and proximity to interference sources like HF communication devices.

Device Shutdown and Electrode Management

Explains that connected electrodes prevent automatic shutdown, requiring manual disconnection and power-off.

Setup, Use, and Technical Information

Scope of Product Delivery

Lists all items included in the product package, such as software, cables, adapters, and accessories.

Data Transfer: MyoBoy to PC

Details connecting the MyoBoy to a PC via USB, including driver installation and cybersecurity recommendations.

Data Transfer: MyoBoy to Prosthesis

Explains using communication cables and test adapters for data transfer between the MyoBoy and the prosthesis.

Establishing Power and Electrode Connections

Guides on installing the battery and connecting electrodes to the MyoBoy, ensuring correct polarity.

Product Operation: Powering On/Off

Describes the procedure for turning the product on, including the self-test, and how it switches off automatically.

Display Interpretation and Settings Adjustment

Explains the LED bar display for muscle signals and how electrode positioning and settings influence the displayed data.

Legal Compliance and Liability

Outlines liability conditions, trademark information, and CE conformity with European medical device requirements.

Technical Data and Ambient Conditions

Provides general technical specifications, including reference number, service life, dimensions, weight, and ambient conditions.

Appendix: Explanation of Symbols

Explains the meaning of various symbols used in the document, such as CE, Manufacturer, Lot number, and Medical device.

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