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PROTEOR FREEDOM QUATTRO - User Manual

PROTEOR FREEDOM QUATTRO
145 pages
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Table of Contents

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Summary

01 | System Components

02 | Terms; Symbols Used In This Guide

Type BF Applied Part Symbol

Symbol indicating the device is a Type BF applied part.

WEEE Directive Symbol

Indicates proper disposal of electronic waste.

FCC Declaration of Conformity Symbol

Confirms compliance with FCC regulations.

Manufacturer Symbol

Identifies the manufacturer of the product.

Serial Number Symbol

Unique identifier for the product unit.

Consult Operating Instructions Symbol

Symbol advising to refer to the user manual.

Key Pad Function Symbol

Symbol representing the keypad's function.

04 | Product Description

05 | Indications for Use

Transfemoral Amputation

Indication for users with transfemoral amputation.

Knee Disarticulation Amputation

Indication for users with knee disarticulation amputation.

Hip Disarticulation Amputation

Indication for users with hip disarticulation amputation.

Congenital Lower-Limb Deficiencies

Indication for users with congenital lower-limb deficiencies.

06 | Intended Use

User Weight Limit

Specifies the maximum user weight limit for the device.

Ambulatory Level Classification

Defines the suitable ambulatory level (K3/K4) for the device.

07 | Contraindications

Insufficient Hip;Pelvic Muscle Control

Contraindication due to lack of sufficient hip or pelvic voluntary muscle control.

Insufficient Cognitive Ability

Contraindication due to insufficient cognitive ability to manage the device.

08 | Product Technical Specifications

ISO 10328 Compliance

Compliance with ISO 10328 standard for prosthetic limb testing.

IEC 60601-1 Compliance

Compliance with IEC 60601-1 medical electrical equipment standard.

IP67 Water Resistance Rating

Indicates dust-tight and protection against immersion in water up to 1 meter.

09 | Physical Properties

Product Weight

Specifies the weight of the QUATTRO knee.

Build Height

Specifies the vertical dimension of the QUATTRO knee.

Maximum Flexion Angle

Indicates the maximum degree of knee flexion.

10 | Environmental Specifications

Operating Temperature Range

Defines the acceptable temperature range for device operation.

Storage Temperature Range

Defines the acceptable temperature range for device storage.

Altitude Range

Specifies the operational altitude range for the device.

Humidity Range

Defines the acceptable humidity levels for the device.

Water Resistance and Submersion

Details water resistance rating (IP67) and submersion guidelines.

11 | Basic Operation

11.1. Battery Information

Provides details on operating voltage, charger voltage, and battery life.

11.2. Battery Charge Port Location

Shows the location of the battery charge port on the device.

11.3. Power-off Flexion Resistance Adjustment

Identifies the location of the screw for adjusting power-off flexion resistance.

11.4. Keypad Location and Functionality

Details the location and functions of the keypad buttons and indicators.

11.5. Charging the Battery

Step-by-step guide on how to insert the charging connector.

11.6. Keypad Operation

Instructions for operating the keypad, checking status, and managing modes.

11.6.3. Pairing with Mobile App

Steps to pair the QUATTRO knee with a mobile app via the wireless button.

11.6.4. Entering Storage Mode

Procedure for placing the knee into storage mode using multiple buttons.

11.7. Keypad Button Reference

Reference table for keypad button features, actions, and hold times.

11.10. Modes of Operation

Details various operational modes including Sitting, Obstacle Assist, Cycling, and Golf.

11.11. Power-Off Behavior

Describes the knee's behavior when power is off and how to adjust resistance.

Stance Lock Functionality

Engaging the Flexion Lock

Disengaging the Flexion Lock

12 | Knee Cap Replacement

Removing the Knee Cap

Procedure for removing the knee cap using a hex key.

Installing the Knee Cap

Procedure for installing the knee cap using a hex key and screws.

13 | Alignment and Setup

GaitLab App for Alignment and Setup

Information on using the GaitLab app for alignment and setup.

Freedom Innovations Patient Apps

Information on using Freedom Innovations apps for patients.

14 | Cleaning the QUATTRO Knee

15 | Settings Transfer and Factory Reset

Transferring Settings Between Knees

Steps to copy and paste settings between QUATTRO knees using the app.

Resetting to Factory Defaults

Procedure to reset all device settings to their original factory configuration.

16 | Warranty and Service Information

17 | Technical Support Contacts

User Support Contact

Contact information for user support via a Certified Prosthetist.

Prosthetist Technical Support

Contact information for technical support and training materials.

US Service Shipping Address

Address for shipping knees requiring service from the US.

European Service Shipping Address

Address for shipping knees requiring service from Europe.

18 | Electromagnetic Compatibility Precautions

Electromagnetic Compatibility Precautions

Details precautions regarding electromagnetic compatibility (EMC) for the QUATTRO device.

19 | Guidance and Manufacturers Declaration

20 | CE Conformity

21 | Authorized Representative Information

PROTEOR FREEDOM QUATTRO Specifications

General IconGeneral
BrandPROTEOR
ModelFREEDOM QUATTRO
CategoryMedical Equipment
LanguageEnglish