Freedom Innovations Kinnex 2.0 User manual

1
™
Instructions
for
Use
2.0

Freedom Innovations | Kinnex 2.0 | Instructions for Use
Contents
System Components 4
Terms / Symbols Used In This Guide 4
Warnings / Safety Precautions 6
Product Description 7
Intended Use
Indications
Product Specifications
Physical Properties
Environmental
Basic Operations 8
Manual Adjustments 8
Button Symbols and Functions
8
Battery Function
8
LED Button Quick Reference Sheet
10
Changing Footwear/Shoe Selection
12
Manual Lock Feature
12
Long Term Storage Mode 13
Kinnex App for Patients 14
Downloading and Launching App
14
Connecting & Pairing via Kinnex App
14
Check Battery Charge Level via Kinnex App
14
Change Footwear Option via Kinnex App
14
Making Minor Adjustment via Kinnex App
15
Connecting/Tools via Kinnex App
15
Tools Utilization within Kinnex App
15
Warranty 16
Technical Support 16
Electromagnetic Compatibility Precautions 16
Kinnex Product Detail 16
2.0

5
4
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
Kinnex
Don
Do
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Battery
Change Footwear
Bluetooth
Certied Prosthetist
Kinnex Ankle/Foot Device
Put on
Take o
Part Description
Kinnex Battery Wall Charger
Universal Wall Adapters
Kinnex IFU
Kinnex Patient Quick Set Up Guide
Kinnex Certied Prosthetist Quick Set up Guide
Footshell
Terms / Symbols Used In This Guide
Included w/Kinnex Available/Sold SeparatelyQty
System Components
Part Number
YES
YES
YES
YES
YES
YES
1
1
1
1
1
1
YES
YES
YES
YES
YES
YES
F14-00-CHRG1-00
F14-00-ADAPT-00
IFU-03-009
CG-03-009
CG-03-010
Varies
FCC Declaration of Conformity
Manufacturer
Serial number
Consult operating instructions
Key Pad Function
CEMark

Freedom Innovations | Kinnex 2.0 | Instructions for Use
76
•Failure to comply with safety precautions can result in Kinnex
malfunctioning and risk of injury to the user.
•Always exercise good judgment and common sense when
using Kinnex.
•Initial operating of Kinnex should be done in the presence of
a trained care professional.
•Do not attempt to open or modify any component of Kinnex.
•If any issues or concerns with the Kinnex arise, contact
Prosthetist for assistance. DO NOT attempt to make technical
repairs.
•Cover Kinnex with a foot cover while in use to prevent foreign
objects from being lodged in joints.
•Engage Kinnex Manual Lock when driving a vehicle.
(see “Manual Lock”)
When the battery is completely depleted the Manual Lock
feature is not available, and driving is NOT recommended
•Engage Kinnex Manual Lock when descending stairs step
over step.
•Leaving the Manual Lock engaged can result unintentional
loss of stability if user forgets ankle is locked.
•Improper and unsafe use of Kinnex may result in injury.
Please read the instruction manual thoroughly before using.
•Do not use Kinnex while the battery is charging. Be sure to
disconnect it from the charger prior to putting on the
prosthesis.
•If it becomes necessary to isolate Kinnex from the mains
while charging, unplug the battery charger.
•If unusual movement or product wear is detected in
a structural part of a prosthesis at any time, immediately
discontinue use of the device and consult a clinical specialist.
•Do not use if Kinnex enclosure or covers are broken.
•Kinnex 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.
•Kinnex contains small parts and cords that can be a potential
choking hazard.
•Kinnex is not for running, jumping or high activity usage.
Kinnex is a microprocessor controlled hydraulic ankle/foot
that monitors sensors to control plantar and dorsiexion
resistance.
Intended Use
Kinnex is intended for use by individuals with lower limb
amputations who would benet from improved gait dynamics.
Indications
Kinnex is indicated for use as a component in a prosthetic leg
for individuals with lower limb deciency including:
•Individuals with unilateral or bilateral transtibial
amputations
•Individuals with unilateral congenital limb loss
Product Technical Specs
Kinnex is tested and compliant with the following standards
•IEC/EN60601-1
•ISO 10328
Physical Properties
Weight Limit for low activity users: 125kg/275lbs
Weight Limit for moderate activity users: 100kg/220lbs
Average Product Weight: 1.49kg/3.28lbs (without footshell)
Build Height: 186mm / 7.32in
Heel height adjustability: 0-51mm / 0-2in
Suitable for ambulatory level: K3
Environmental
•Operating Temperature Range: 0 to 45 °C / 32 to 113 °F
•Storage Temperature Range: -20 to 80 °C / -4 to 176 °F
•Humidity Range: 0 – 100%
•Altitude Range: 0-5,000 m (0-16,400 ft)
•Water resistance: rated to IP67
-Kinnex is safe for occasional submersion in fresh
water up to 1 m (3 ft) for up to 30 minutes. The
user should ensure the charging port cover is
properly inserted prior to water exposure. The
user should dry the ankle with a towel once out
of the water.
- Kinnex should not be used for bathing.
- Kinnex should not be immersed in saltwater or
chlorinated water as these may cause corrosion.
Failure to comply will void the warranty.
- If Kinnex is sprayed by or accidentally submerged
in salt water or chlorinated water, immediately
rinse with fresh water and allow to dry.
Product Description
•MDD 93/42/EEC
•ISO13485
Warnings / Safety Precautions

Freedom Innovations | Kinnex 2.0 | Instructions for Use
9
8
Basic Operations
Manual Adjustments
To manually adjust Kinnex, utilize the three buttons on the front
of Kinnex. The buttons are used to control and interact with
Kinnex when a mobile device is not available or desired.
Button Symbols and Functions
Battery Function
Charging Battery
• To charge the battery:
- Remove the rubber plug from the port at the top front
of the ankle
- Connect to wall power supply provided with Kinnex.
•The green battery indicator light at the front of
the ankle will begin to ash indicating that the
ankle is charging. After a short period of time,
the indicator light will turn o but charging will
continue. While charging, the indicator light can
be turned back on by pressing and releasing the
battery button on the front of the ankle. The
duration of the ash indicates the amount of
charge in the battery. The longer the ash, the
closer the battery is to being charged.
- Once the ankle is completely charged, the indicator
light will be solid green when the button is pressed
and released.
•A full charge requires three hours or less using
the wall power supply.
CAUTION: Use only the wall power supply provided with
Kinnex for battery charging.
Battery Charge Level
•To manually check the charge level of Kinnex when
unplugged (not charging) using the button located on the
front of the ankle:
-Press and release the Battery Button on the front of
the ankle.
-Indicator lights will illuminate briefly giving the charge
level as shown in table below:
Indicator Light Charge Level
Solid green 51% - 100%
Flashing green 21% - 50%
Solid red 11% - 20%
Flashing red 1% - 10%
•To manually check the charge level of Kinnex while
charging (plugged in):
-Press and release the Battery Button on the front of
the ankle.
-The green indicator light will flash briefly. The longer
the flash, the closer the battery is to being charged.
A solid light indicates the battery is fully charged.
Battery Low Indicators
• Low battery notifications: When the battery charge
level is at or below 20%, the ankle will periodically
vibrate. While walking, the vibration feels like a grinding
sensation as you take a step. While not walking, the
vibration feels like a subtle buzzing. These notifications
can be dismissed by quickly pressing and releasing the
Battery Button on the front of the ankle, or by using the
mobile app.
•20% charge indicator: When the battery charge level
falls to 20%, the ankle will notify every 15 seconds until
dismissed. No indicator lights will flash.
•10% charge indicator: When the battery charge level
falls to 10%, the indicator light at the front of the ankle
will flash red, and the ankle will notify every 5 seconds
until dismissed.
•2% charge indicator: When the battery charge level
falls to 2%, the indicator light at the front of the ankle
will flash red, and the ankle will notify every 2 seconds.
Notifications cannot be dismissed when the battery
charge is 2% or lower.
•0% charge indicator: When the battery charge level
falls to 0%, the ankle will power off and go into a low
stiffness mode.
•Battery / Power Status Button
•Change Footwear Button
•Bluetooth Button

1110
Freedom Innovations | Kinnex 2.0 | Instructions for Use
LED Button Quick Reference Sheet
Each button on Kinnex incorporates one or more indicator
lights to indicate the status of Kinnex. The table below
lists what the indicator lights mean.
Indicator Light Location Meaning Action
Solid green
Battery Button
Flashing green
Battery Button
Solid red
Battery Button
Flashing red
Battery Button
Solid white
Change Footwear Button
Flashing white
Change Footwear Button
Solid blue
Bluetooth Button
Battery is fully charged.
Charging (plugged in):
Battery is charging.
Plugged in (discharging):
Battery charge level has
dropped below 50%.
Battery charge level
is low.
Battery is almost fully
depleted. Once fully depleted,
Kinnex will go into a low
stiffness mode.
Manual Lock is engaged.
Manually adjusting
footwear.
Connected in Clinician Mode.
Flashing blue
Bluetooth Button
Alternating red and
white
Battery and
Change Footwear
Buttons
Alternating red and
Ready for Clinician Mode
connection.
User: Attempt to
change footwear failed.
Prosthetist: Sensor
calibration failed.
Kinnex system error.
Kinnex is fully charged and
ready to use.
Charging (plugged in):
Continue charging battery
until solid green light
for full charge.
Unplugged (discharging):
Charge the battery in the
next few hours.
Charge battery as soon
as possible.
User will notice
reduced resistance.
Take caution performing
normal activities.
Kinnex is locked in
desired position.
Stand evenly weighted
and wait 5 seconds.
Clinician can configure
Kinnex. To exit, press
Bluetooth Button for 3
seconds until the blue
indicator light turns off.
Clinician can connect to
Kinnex. To exit, press
Bluetooth Button for 3
seconds until the blue
indicator light turns off.
User: Repeat change
footwear process.
Prosthetist: Repeat
sensor calibration process.
Contact Prosthetist.
blue.
Battery and
Bluetooth Buttons

Freedom Innovations | Kinnex 2.0 | Instructions for Use
1312
Changing Footwear/Shoe Selection
The Change Footwear Button will allow you to manually
change your footwear without use of the Kinnex App:
Follow these steps to manually change shoes.
1. Don Kinnex with new footwear.
2. Press and hold the Change Footwear Button until
the indicator light in the button begins to flash
white.
3. Once the white indicator light begins to flash, stand
with toes even and with feet
shoulder width apart.
4. Remain still until the white indicator light stops
flashing. (Usually takes <5 seconds.)
5. If Kinnex ankle cannot adjust within 10 seconds it
will indicate an error condition by alternating
flashing of the white and red indicator lights. The
error light indicator will flash for 15 seconds or until
the change shoes button his pressed and released.
Manual Lock
The Manual Lock feature is designed to assist with
driving a car, putting on clothes or footwear, or any
activity where a xed ankle position is desired. When
active, Kinnex will stay in the current position until a
double-press of the change shoes button is used, or the
manual lock is switched o in the app.
To manually engage the Manual Lock:
1. Move Kinnex to the desired orientation.
2. Press the Change Footwear Button twice quickly.
3. The Change Footwear Button white indicator light
will turn on while Kinnex is in Manual Lock mode.
4. Perform the desired activity.
5. Press the Change Footwear Button twice quickly to
disengage the Manual Lock.
6. The white indicator light will turn off upon
completion.
Caution: Engaging the Manual Lock feature for driving
is required. Leaving the Manual Lock engaged can
result in unintentional loss of stability if user forgets
ankle is locked.
When the battery is completely depleted the Manual Lock
feature is not available, and driving is NOT recommended.
Long-Term Storage Mode
If Kinnex needs to be stored for more than 60 days, it should
be put into long-term storage mode to avoid over discharge
of the battery pack.
To put Kinnex into long-term storage mode:
•Press and hold both the Change Footwear and the
Bluetooth Buttons simultaneously for 6 seconds.
•After 6 seconds, all three lights will flash on and off
simultaneously as an indicator that the command was
successful.
•After the lights turn off Kinnex will enter into longer
term storage mode and power off.
To bring the ankle out of long-term storage mode:
• Charge the battery as you normally would by removing
the rubber plug from the port at the top front of the
ankle and connect the wall power supply provided
with Kinnex.
• The green indicator light at the front of the ankle will
begin to ash indicating that the ankle is charging
and powered on.

Freedom Innovations | Kinnex 2.0 | Instructions for Use
1514
Kinnex App for Patients
The Kinnex App for patients will allow patient to change the
following settings of the product via app:
•Check battery charge level.
•Change Footwear options.
• Engage Manual Lock.
•Make minor adjustment to the ankle settings based on
established settings made by Prosthetist.
•NOTE: User will not be able to connect via the Kinnex
App when Kinnex is in “Clinician Mode”.
(A blinking blue light on the ankle will indicate that
Kinnex is in “Clinician Mode”. To exit “Clinician Mode,”
press and hold the Bluetooth Button until the blue light
turns off.)
Downloading and Launching App
• Download the Kinnex App from the Apple App Store or
the Google Play App Store.
Connecting and Pairing to Kinnex via Kinnex App
• Once App is open, tap the “Connect” button.
• Tap the serial number (or custom name) of the ankle to
connect.
• Note: When connecting to Kinnex with mobile device for
the rst time, the Kinnex App will instruct to press the
Bluetooth button to acknowledge the pairing request.
If the pairing request is not acknowledged within 30
seconds, the connection attempt will fail.
Check Battery Charge Level via Kinnex App
Check the battery charge level of Kinnex by selecting
the “Status” button in the Kinnex App.
Change Shoes Option via Kinnex App
Change shoes option by selecting the “Shoes” button
in the Kinnex App. Once inside the “Shoes” Window,
simply click on shoe of choice.
Status
Making Minor Adjustment to Kinnex via Kinnex App
By utilizing the “Adjust” feature in the Kinnex App,
minor adjustments to the ankle setting can be
made based on established settings made by the
Prosthetist. To do this, select the “Adjust” button
in the Kinnex App.
• From here the user will be able to increase or
decrease the adjustments to the Heel, Ankle,
and Toe based on parameters established by
the Prosthetist.
Connecting/Tools via Kinnex App
Selecting the “Tools” button in the App will allow
access to the following:
•Manual Lock Mode
•Disconnecting from Kinnex
•Unpairing and disconnecting with Kinnex
Tools Utilization within Kinnex App
The following features are available within the Tools Section
of the Kinnex App.
Manual Lock
When activated, the Manual Lock will maintain
Kinnex in its current position until one of the
following occurs:
•The button is deactivated in the App.
•The Change Footwear Button is double-
pressed.
Disconnect
The Disconnecting feature will disconnect the app
from Kinnex. However it will not unpair Kinnex from
the App. This will allow connection without repairing
at a later time.
Unpair and Disconnect
The unpair and disconnect feature will unpair and
disconnect the App from Kinnex. A window will
pop up requesting to conrm unpairing prior to
proceeding. If Kinnex is unpaired from the App and
assistance is required, please contact Prosthetist.
Shoes
Adjust
Tools

Freedom Innovations | Kinnex 2.0 | Instructions for Use
1716
Warranty
See terms of Warranty for details.
Technical Support
•For User Support, please contact Prosthetist.
•For Prosthetist Technical Support, please contact
Freedom Innovations toll-free at 1.888.818.6777
Electromagnetic Compatibility Precautions
The Freedom Kinnex™ microprocessor ankle/foot needs
special precautions regarding electromagnetic
compatibility (EMC). Specifically it needs to be installed
and put into service according to the EMC information
provided as follows:
• Kinnex may be susceptible to electromagnetic
interference from portable and mobile RF
communications devices such as mobile (cellular)
telephones.
• Kinnex 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.
Emissions Compliance Electromagnetic Environment—
Test Guidance
RF Emissions
EN 55011/ Group 1 Kinnex 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 Kinnex 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.
CE Conformity
The Freedom Kinnex is tested and certied to comply with
the MDD 93/42/EEC (EN 55011 Class B and EN60601-1
and EN60601-1-2), STSI EN 300-328 under R&TTE Directive
1999/5/EC and ISO10328. The device complies with Part 15
of the FCC Rules and carries the CE mark.
Authorized Representative
Advena Ltd.
Pure Oces
Plato Close, Warwick, CV 34 6 WE
United Kingdom
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
Kinnex is intended for use in the electromagnetic
environment specied below. The customer or user
of Kinnex should assure that it is used in such an
environment.

1918
B
D
C
A.
Key Pad buttons
B.
Charging port
C.
RapidResponse™ Valve Technology
D.
Carbon ber foot plate
1
2
3
Key Pad Button Functions
Power Status Button
•Check battery power levels
Change Footwear Button
• Change footwear and calibrate ankle to
new footwear
• Manual Lock Mode
Bluetooth Button
•Pair ankle to smart device
•Clinician Mode
1
2
3
Kinnex Product Detail
A
2.0

IFU-03-009, Rev. B 9/19
Connect with us
Global Headquarters
3 Morgan
Irvine, CA 92618
toll free: 888-818-6777
phone: 949-672-0032
fax: 949-672-0084
www.freedom-innovations.com
#freedomeveryday
©2019 Freedom Innovations, LLC. All rights reserved.
Kinnex is a trademark of Freedom Innovations, LLC.
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