Warnings / Safety Precautions; Product Description; Indications; Intended Use - PROTEOR Freedom QUATTRO Instructions D'utilisation

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03 | Warnings / Safety Precautions

Please read this instruction manual thoroughly before using.
Failure to comply with safety precautions can result in the
QUATTRO malfunctioning and risk of injury to the user.
Initial operation of the QUATTRO should take place in the
presence of a trained care professional.
Do not open or modify any component(s) and DO NOT make
repairs on the QUATTRO unless otherwise directed in this IFU.
If any issues or concerns with the QUATTRO arise, contact
your Prosthetist for assistance.
Improper and unsafe use of QUATTRO may result in injury.
Do not use the QUATTRO while the battery is charging via the
wall charger. Be sure to disconnect from the charger prior to
putting on the prosthesis.
- Do not submerge Quattro while charging using the
Quattro Booster Battery Pack.
If unusual movement or wear is detected in a structural part
of the prosthesis at any time, immediately discontinue use
of the device and consult your Prosthetist.
The QUATTRO contains a Lithium-ion battery that is not field
replaceable and requires factory service for repair. Lithium-ion
batteries contain hazardous metals and should never be
disposed of in residential or commercial garbage. They
should never be incinerated because they may explode.
Reference local regulations for proper disposal of product.
If power is lost from the QUATTRO knee, it will default to
the Power-Off Flexion resistance setting.
When the battery is depleted, use extreme caution when
descending ramps and stairs.
The QUATTRO contains small parts and cords that can be
potential choking hazards.
If the QUATTRO has been stored outside its Operating
Temperature Range, allow the knee to acclimate to the
operating environment for a minimum of 30 minutes
before use.
Avoid running or other intense physical exercise above the
specified operating temperature limit (45 °C [113 °F]). This
can damage your QUATTRO.
The proximal connection to the patient is the Applied Part of
the device. All other external surfaces of the device, including
the power supply and cord, are the Accessible Parts.
Failure to comply with the instruction for use will void the
warranty.
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PROTEOR |
FREEDOM QUATTRO

04 | Product Description

The QUATTRO is a microprocessor controlled, single axis
prosthetic knee joint system with internal sensors to control
knee flexion and extension resistance.

05 | Indications

The QUATTRO is indicated for use as a component in a
prosthetic leg for individuals with unilateral
or bilateral lower-limb amputations or limb deficiencies,
including:
Transfemoral amputation
Knee disarticulation amputation
Hip disarticulation amputation
Congenital, lower-limb deficiencies

06 | Intended Use

The QUATTRO is intended for use by prosthesis wearers
who would benefit from the safety, stability, and improved
gait dynamics of a microprocessor controlled knee. Quattro
should only be fit by a trained O&P professional.
User Weight Limit: 136kg/300lbs
Suitable for ambulatory level: K3/K4

07 | Contraindications

The QUATTRO is inappropriate for users with:
Insufficient hip joint or pelvic voluntary muscle control
Insufficient cognitive ability to charge the knee and care
for the device

08 | Product Technical Specifications

The QUATTRO is tested and compliant with the following
standards:
ISO 10328-P7-136 kg [300 lbs.] (Body mass limit not to be
exceeded for high activity users)
IEC 60601-1
Rating of IP67 under IEC 60529
| Instructions for Use
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