Freedom Innovations Kinnex Instructions For Use Manual

Instructions
for
Use
Freedom Innovations | Kinnex | Instructions for Use
Contents
System Components 4
Warnings/Safety Precautions 6
Intended Use 7
Indications 7
Product Specications 7
Physical Properties 7
Environmental 7
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
Apparel Assist Mode 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 17
Kinnex Product Detail 18
2
System Components
Freedom Innovations | Kinnex | Instructions for Use
Part Description
Kinnex Battery Wall Charger F14-00-CHRG1-00 YES 1 YES
Universal wall adapters F14-00-ADAPT-00 YES 1 YES
Kinnex IFU R-720-239 YES 1 YES
Kinnex User Guide R-720-241 YES 1 YES
Kinnex Certied Prosthetist Set up Guide R-720-240 YES 1 YES
Footshell Varies YES 1 YES
Part Number
Included w/Kinnex Qty Available/Sold Separately
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
FCC Declaration of Conformity
Battery
Change footwear
Manufacturer
N
Serial number
S
Consult operating instructions
Key Pad Function
CEMark
CP
Kinnex
Don
Do
Bluetooth
Certied Prosthetist
Kinnex Ankle/Foot System
Put on
Take o
54
Freedom Innovations | Kinnex | Instructions for Use
Product Description
Kinnex is a microprocessor controlled hydraulic ankle/foot that monitors sensors to control plantar and dorsiexion resistance.
Intended Use
Kinnex is intended for use by individuals with lower limb amputations who would benet from improved gait dynamics.
Warnings / Safety Precautions
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”) 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 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.
Kinnex contains small parts and cords that can be a potential
choking hazard.
Kinnex is not for running, jumping or high activity usage.
Indications
Kinnex is indicated for use as a component in a prosthetic leg for individuals with lower limb deciency including:
Persons or Individuals with unilateral or bilateral transtibial and
transfemoral amputations
Individuals with congenital limb loss below the knee
Product Technical Specs
Kinnex is tested and compliant with the following standards
IEC/EN 60601-1 MDD 93/42/EEC
ISO 10328 ISO 13485
Physical Properties
Weight Limit for low activity users: 125 kg Weight Limit for moderate activity users: 100 kg Average Product Weight: 1.49 kg (without footshell) Build Height: 186 mm Heel height adjustability: 0 – 51 mm Suitable for ambulatory level: K3
Environmental
Operating Temperature Range: 0 to 45 °C
Storage Temperature Range: -20 to 80 °C
Humidity Range: 0 – 100%
Altitude Range: 0 – 5,000 m
Weather resistance: rated to IP67
- Kinnex is safe for occasional contact with fresh water (up to 1 m
for up to 30 minutes). If Kinnex was in contact with water, 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.
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