PROTEOR FREEDOM QUATTRO User manual

1
Instructions for Use
by

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
Microprocessor Knee
by

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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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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CEMark
Battery/Power Status Button
Change Mode Button
Wireless Button
Certied Prosthetist
MPC Knee System
Part Description
QUATTRO Battery Wall Charger & Adapters
QUATTRO Instructions for Use (IFU)
QUATTRO Prosthetist Guide
QUATTRO User Guide
External Booster Battery Kit
Included w/QUATTRO Available/Sold SeparatelyQty
01 | System Components
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
FCC Declaration of Conformity
Manufacturer
Serial number
Consult operating instructions
Key Pad Function

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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•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.
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
03 | Warnings / Safety Precautions

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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11 |Basic Operation
11.1. Battery Information
Operating voltage: 7.4 VDC
Charger input voltage: 12 VDC
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:
8
09 |Physical Properties
• Product Weight: 1655 g [3.56 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]
• Storage Temperature 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.
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

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11.4. Keypad Location & Functionality 11.5. Charging Battery
PROTEOR | FREEDOM QUATTRO | Instructions for Use
Inserting Charge Connector
a. Pull the protective charging port cover open and
insert charge connector with the cable oriented
up. The connector is magnetic and will snap into
place. Once inserted, the battery LED button
will illuminate briey, indicating that the knee
is charging.
Battery
Status
Red or
Green
Change
Mode
White
Wireless Blue
LED Colors

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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Feature Action Hold Time
Check battery status Press Battery Button
Flexion lock enable Double Press Mode Button
Flexion lock disable Double Press Mode Button
Check activity Press Mode Button
Toggle activity Hold Mode Button 3 sec
Pair Press Wireless Button
Storage mode Hold Mode + Wireless Buttons 6 sec
Reset Hold Battery Button 6 sec
11.6.3. Pair Knee with Mobile App
To pair your QUATTRO to the app the rst
time you connect, quickly press and release
the button when prompted by app
Wireless
11.6.4. Putting the Knee into Storage Mode
Hold both the Mode button and the Wireless
button at the same time for six seconds
until all the lights ash, and then turn o.
When in storage mode the QUATTRO will be
completely powered o and unresponsive.
Pressing the power button will not turn the
device back on. To turn the knee back on,
you must plug in the charger. The knee is
shipped in Storage Mode from the factory
(must be plugged into power source to turn
on).
NOTE: The device will not enter storage mode
if connected to the charger.
Wireless
Mode
+
11.7. Keypad Button Reference
11.6.2. Activity Mode
Press and release button to show current
activity mode. Slow ashing white light
means you are in Walking Mode. Fast
ashing means you are using your currently
selected Alternate Activity Mode.
Change Activity Mode
Hold button for three seconds to switch
back and forth between Walking Mode and
your currently selected Alternate Activity
Mode. When changed, lights will indicate
new mode (see above). White and red ashing
means there is no Alternate to select, or
it is unsafe to change modes right now.
Set or Release Flexion Lock
Double press button to set or release the
exion lock. When locked, the white light
will be solid.
Mode
11.6. Keypad Operation
11.6.1. Check Battery Status
Press and release button to show the
current battery power status.
When QUATTRO is plugged into a charger
Current battery charge is indicated by a
ashing green light. The more the battery
is charged, the longer time each ash will
stay lit.
Rebooting The Knee
Hold button for six seconds until the green
and blue lights ash. Only use this feature
as directed by your prosthetist if you are
having problems with your device.
Power
Normal mode
Indicator Light Charge Level
Solid Green 51% - 100%
Flashing Green 21% - 50%
Solid Red 11% - 20%
Flashing Red 1% - 10%

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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Single Press to
Check Status
Double Press
to Enable/Disable
Lock
Long Press
to Toggle
between
Walking and
Alternate
Activity
11.9. Mode Button Reference
White LED blinks to indicate current activity. Slow
blink indicates “Walking”, and fast blink indicates the
alternate.
LEDs blink red/white to indicate error. No activity is
active to check because the knee is in Locked Mode.
Flexion lock is engaged. White LED stays solid.
Flexion lock is disengaged. White LED stays o.
Previously selected activity is resumed.
LEDs blink red/white to indicate nothing has
happened.
Alternate activity is selected. White LED blinks fast
to indicate alternate is now selected.
“Walking” activity is selected. White LED blinks slow
to indicate “Walking” is now selected.
Unlocked
Locked
Unlocked
Locked
Current activity is “Walking”, but
an alternate has NOT been
congured
Current activity is “Walking” and
an alternate HAS been congured
Current activity is alternate
11.8. LED Reference
User Press Current State Product Behavior
Condition LED Behavior
Battery is charged Battery LED solid green
Battery is charging Battery LED ashing green
Battery is low Battery LED solid red
Battery is very low Battery LED ashing red
Knee is manually locked LED solid white
Activity checked or change LED ashing white: slow (walking) or fast (alternate)
Activity change failed Battery LEDs alternate red / white
Entering storage mode Flashing red / blue / white LEDs
System error Battery/Wireless LEDs alternate red / blue
Booting Flashing green / blue

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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11.10. Modes
Sitting Mode:
The QUATTRO features two available behaviors when sitting, and
the adjustment is found under the “Tools” tab along the bottom
of the GaitLab and Freedom Innovations apps. With Sitting Mode
turned on (default), when the knee is unweighted and the thigh
reaches a 90 degree angle or greater, the knee exes without
resistance. With Sitting Mode o, the knee will continue to have
hydraulic resistance to exion independent of thigh exion angle.
Note: if Sitting mode is turned o, it will also disable Cycle Mode
and Obstacle Assist.
Obstacle Assist:
Obstacle Assist can be turned o or on during full programming,
and in the GaitLab App under “Setup” and “Adjust” after full
programming is completed. With Obstacle Assist turned on
(default), the knee will ex with no resistance when the thigh
reaches 35 degrees of exion or greater and is unweighted. This
is helpful for stepping over tall objects or entering a high vehicle.
When Obstacle Assist is turned o, the knee will ex slowly with
hydraulic resistance when unweighted independent of thigh
exion angle. Note: if Sitting Mode is turned o, it will also disable
Obstacle Assist.
Cycling Mode:
In Cycling Mode, the Knee will enter in low resistance when the user’s
thigh is near the horizontal plane (this position occurs when getting
on the bike or during normal pedaling). The Knee will remain in low
resistance until the user puts weight on the unit in full extension
(triggering the QUATTRO to return to normal walking mode).
Note: if Sitting mode is turned o, it will also disable Cycle Mode.
Golf Mode:
Golf Mode allows you to limit the amount your knee exes while
playing golf. After selecting golf mode in the Freedom app as the
alternate mode, navigate to the adjustment screen. On this screen you
will have 3 choices for dierent degrees of exion that will be allowed.
Each of these can be customized by pressing the“+”or“-“.This allows
you to have 3 custom settings for the amount of exion needed for
a particular golf swing.
!IN GOLF MODE THE KNEE WILL ONLY FLEX TO
THE DEGREE THAT HAS BEEN CHOSEN IN THE APP. DESCENDING
STAIRS AND SLOPES SHOULD BE AVOIDED WHEN IN GOLF MODE.
Stance Lock:
The QUATTRO features a Stance Lock for stability on a exed knee.
When the user stops the thigh at a exion angle and weights
the knee, it will automatically lock further exion. The lock will
automatically disengage when the thigh moves in an extension
moment or the knee is unweighted.
Note: Stance Lock is available from 0-70°of exion.
Engaging the Flexion Lock:
To engage exion lock, in any Activity Mode, double click the
mode button to engage the exion lock. The button lights up
with a solid white light to indicate that the Flexion Lock is engaged.
When the lock is engaged, the knee can straighten but
it cannot bend any further than the current angle. If the knee
is straightened to a more upright position, the lock re-engages
at the new angle. The knee will remain locked at this position
until the knee is straightened or the exion lock is disengaged.
The solid white light remains on as long as the Flexion Lock is
engaged.
Note:When the Flexion Lock is engaged and the knee is unweighted,
it will be locked in both exion and extension.
Disengaging the Flexion Lock:
With the lock engaged, double click the mode button to disengage
the Flexion Lock. The solid white light now turns o, indicating
that the Flexion Lock has disengaged. The knee returns
to the currently selected Activity, i.e. Walking.
Note: Stance Lock is available from 0-70° of exion.

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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Removing the Knee Cap
a. Use a 3/32” Hex Key to
remove the two socket head
cap screws from the Knee
Installing the Knee Cap
b. Install Knee Cap as indicated
below. Tighten the 2 socket
head cap screws using the
3/32”Hex Key.
NOTE: Tighten until ush plus
1/4 turn, do not over
torque screws.
12 | Knee Cap Replacement
3/32”
Hex Key
13 | AlignmentandSetup
Follow the Clinician User Guide and the GaitLab smartphone
app to properly align and setup the device. GaitLab is required
to calibrate and optimize the microprocessor settings for
each patient. Verify the smartphone requirements before app
installation. Download Apps from the App Store or Google Play
Store.
GaitLab App ( for Clinicians )
Freedom Innovations ( for Patients ):
14 | Cleaning
Use clean tap water to rinse o your QUATTRO knee. A soft-
bristled brush (such as a toothbrush) is acceptable to dislodge
stuck dirt on the outside of the knee only. Using any other
chemicals or soaps on the QUATTRO may void the warranty.
Dry the knee thoroughly with a towel after rinsing. Do not use
a hairdryer, which may damage the electronics and void the
warranty.
15 | Transferring Settings/Resetting to Factory
Defaults
1. Connect to the knee you’d like to transfer the program
from. Once connected, go to the “Tools” tab along the
bottom of the app, then tap “Manage Settings”. Tap
“Copy settings” to save the settings to your device. You
can now disconnect from the programmed knee.
2. Connect to the knee you’d like to transfer the program
to. Go to the “Tools” tab along the bottom of the app,
tap “Manage Settings”, and tap “Paste settings”. You will
get a conrmation message “Are you sure you want to
replace all settings?” Tap “OK” to transfer all settings, and
“Cancel” to cancel the paste and keep the settings as is.
• Reset to factory defaults: this will reset all of the settings
in the knee to factory settings.
• Recommendation: Have the patient sitting while
transferring the program or resetting the knee for safety.
11.11. Power-O Behavior
When the battery is depleted or the knee has been put into
storage mode, a Power-O Flexion resistance is used. The
power-o exion resistance can be adjusted to accommodate
dierent user preferences and weights.
!
PLEASE HAVE YOUR PROSTHETIST ADJUST THIS
SETTING FOR YOU.
Making an Adjustment:
With the QUATTRO knee fully extended, insert a 3mm
hex wrench into the power-o exion resistance screw: CW
adjustments provide more exion resistance and CCW
adjustments provide less exion resistance.
!
DO NOT FLEX THE KNEE WITH THE HEX WRENCH
INSERTED, THIS MAY CAUSE PERMANENT DAMAGE TO
YOUR DEVICE.
Flexion
resistance
adjustment
Note: The knee ships with
the exion resistance at the
middle of the range to allow
for increased or decreased
resistance based on patient
preference.

PROTEOR | FREEDOM QUATTRO | Instructions for Use
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16 | WarrantyandService
Purchase of the QUATTRO includes a 36-month warranty
covering all manufacturer defects eective only if the product
is used according to manufacturer recommendations. The
battery charger, and accessories are provided with a 12-month
warranty. An exteded warranty and service recommendation is
available. See company website for details.
For knee service or repair, please contact PROTEOR at
1.855.450.7300. A loaner knee will be provdied upon request.
For loaner and shipping information please see technical
support section.
17 | Technical Support
• For User Support, please contact your Certied Prosthetist
• For Prosthetist Technical Support, supplementary training
material or to schedule service, please contact Proteor
toll-free at 1.855.450.7300
• A loaner knee can be provided upon request. Knees
requiring service from the US should be shipped in the
provided case to the following address:
PROTEOR USA
3 Morgan
Irvine, CA 92618
• In Europe, please ship to the following address:
PROTEOR
6 rue de la Redoute
21850 St Apollinaire, France
19 | Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
QUATTRO is intendedfor use in the electromagnetic
environmentspecied below. The customer or user
of QUATTRO should assure that it is used in such an
environment.
Emissions Compliance Electromagnetic Environment—
Test Guidance
RF Emissions
EN 55011/ Group 1 QUATTRO uses RF energy only for its
CISPR internal function. Therefore, its RF
emissions are low and are not likely
to cause any interference in nearby
electronic equipment.
RF Emissions
EN 55011/ Class B QUATTRO is suitable for use in all
CISPR establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.
18 | ElectromagneticCompatibilityPrecautions
• The QUATTRO needs specialprecautionsregarding
electromagneticcompatibility(EMC). Specically, it needs
to be installed and put into service according to the EMC
information provided as follows:
• The QUATTRO may be susceptible to electromagnetic
interference from portable and mobile RF communications
devices such as mobile (cellular) telephones.
• The QUATTRO may be interfered with by other equipment,
even if that other equipment complies with CISPR
EMISSION requirements.
• This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired
operation.

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20 | CEConformity
Freedom QUATTRO is tested and certied to comply with the
MDR (EU) 2017/745 (EN 55011 Class B and IEC60601-1, STSI
EN 300-328 under R&TTE Directive 1999/5/EC and ISO 10328).
The device complies with Part 15 of the FCC Rules and carries
the CE mark.
21 | AuthorizedRepresentative
PROTEOR SAS
6 rue de la Redoute
21850 Saint Apollinaire
France
Microprocessor Knee
A
B
C
D
QUATTRO Product Details
A. Key Pad Buttons
B. Charging Port
C. Flexion Resistance Adjustment
D. Replaceable Knee Cap
by
EC REP

IFU-03-014 Rev B
Connect with us
PROTEOR USA
3 Morgan
Irvine, CA 92618
phone: [phone]
email: [email protected]
www.proteorusa.com
#quattroknee
#freedomknee
#FreedomQuattro
#HumanFirst
#PROTEOR
©2021 PROTEOR. All rights reserved.
Freedom QUATTRO is a trademark of PROTEOR.
PROTEOR European Headquarters
6 rue de la Redoute
21850 St Apollinaire, France
Phone: [phone]
Email: [e-mail]
www.proteor.com