PROTEOR FREEDOM QUATTRO User manual

1
Instructions for Use
by

Microprocessor Knee
by
Contents
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Français 26
Deutsch 50
Nederlands 74
Czech 98
Russia 122
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PROTEOR | FREEDOM QUATTRO | Instructions for Use
Contents
System Components Included 4
Terms / Symbols Used in This Guide 4
Warnings / Safety Precautions 6
Product Description 7
Indications 7
Intended Use 7
Contraindications 7
Product Technical Specications 7
Physical Properties 8
Environmental 8
Basic Operation 9
Battery Information 9
Battery Charge Port Access Location 9
Power-O Flexion Resistance
Adjustment Screw Location 9
Keypad Location & Functionality 10
Charging Battery 11
Keypad Operation 12
Check Battery Status 12
Activity Mode 12
Pair Knee with Mobile App 13
Putting the Knee into Storage Mode 13
Keypad Button Reference 13
LED Reference 14
Mode Button Reference 14
Modes 16
Power-O Behavior 17
Knee Cap Replacement 18
Alignment and Setup 19
Cleaning 19
Transferring Settings & Resetting to Factory Default 19
Warranty and Service 20
Technical Support 20
Electromagnetic Compatibility Precautions 20
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions 21
CE Conformity 22
Authorized Representative 22

4
02 | Terms / Symbols Used In This Guide
Type BF applied part
WEEE Directive on waste electrical and
electronic equipment, which should not be
disposed of in regular wastes at the end
of its usable life
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Part Description
QUATTRO Battery Wall Charger & Adapters
QUATTRO Instructions for Use (IFU)
QUATTRO Prosthetist Setup Guide
QUATTRO Patient Setup Guide
External Booster Battery Kit
01 | System Components
Part Number
QNX0601
IFU-03-014
CG-03-011
CG-03-012
ACC0010
FCC Declaration of Conformity
Manufacturer
Serial number
Consult operating instructions
Key Pad Function

PROTEOR | FREEDOM QUATTRO | Instructions for Use
5
Type BF applied part
WEEE Directive on waste electrical and
electronic equipment, which should not be
disposed of in regular wastes at the end
of its usable life
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CP
Quattro
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CEMark
Battery/Power Status Button
Change Mode Button
Wireless Button
Certied Prosthetist
MPC Knee System
Included w/QUATTRO Available/Sold SeparatelyQty
Part Number
YES
YES
YES
YES
NO
1
1
1
1
1
YES
YES
YES
YES
YES
QNX0601
IFU-03-014
CG-03-011
CG-03-012
ACC0010

6
•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 eld
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-O 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
specied 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.
03 | Warnings / Safety Precautions

PROTEOR | FREEDOM QUATTRO | Instructions for Use
7
The QUATTRO is a microprocessor controlled, single axis
prosthetic knee joint system with internal sensors to control
knee exion 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 deciencies,
including:
•Transfemoral amputation
•Knee disarticulation amputation
•Hip disarticulation amputation
•Congenital, lower-limb deciencies
06 | Intended Use
The QUATTRO is intended for use by prosthesis wearers
who would benet from the safety, stability, and improved
gait dynamics of a microprocessor controlled knee. Quattro
should only be t 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:
•Insucient hip joint or pelvic voluntary muscle control
•Insucient cognitive ability to charge the knee and care
for the device
08 | Product Technical Specications
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
04 | Product Description

8
09 |Physical Properties
•Product Weight: 1655 g [3.65 lbs.]
•Build Height: 216 mm [8.5 in]
•Maximum Flexion Angle: 135°
10 |Environmental
•Operating Temperature Range: 0 to 45 °C [32 to 113 °F]
•StorageTemperature Range: -25 to 60 °C [-13 to 140 °F]
•Altitude Range: 0-5,000 m [0 -16,400 ft.]
•Humidity Range: 0% to 100%, including condensation
•Water Resistance: Rated to IP67
- QUATTRO is safe for occasional submersion in fresh
water up to 1 m [3 ft.] for up to 30 minutes.The user
should dry the knee with a towel once out of the water.
- QUATTRO should not be used for showering or bathing.
- QUATTRO should not be immersed in saltwater or
chlorinated water as these may cause corrosion.
- If the QUATTRO is sprayed by or accidentally submerged
in salt water or chlorinated water, immediately rinse with
fresh water and towel dry.

PROTEOR | FREEDOM QUATTRO | Instructions for Use
9
11 |Basic Operation
11.1. Battery Information
Operating voltage: 7.4VDC
Charger input voltage: 12VDC
AC power adapter input voltage: 100-240 VAC, 50/60 Hz
Battery life: Approximately 2 days of use based on the following
user prole:
24-hour Day
Sleeping Sitting Standing Walking Activity Driving
11.3. Power-o Flexion
Resistance Adjustment
Screw Location
11.2. Battery Charge Port
Access Location
!Use only the wall charger or the booster battery
adaptor that are designed for QUATTRO to charge the device.
Only use a 3mm hex wrench for making power o exion
resistance changes.
x

10
11.4. Keypad Location & Functionality
Battery
Status
Red or
Green
Change
Mode
White
Wireless Blue
LED Colors