Reboocon Bionics Intuy Knee User manual

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
1 / 35
Reboocon Bionics B.V. Recover Boost Connect
Intuy Knee
Instructions for Use (EN)
[Original Instructions]

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
2 / 35
Reboocon Bionics B.V. Recover Boost Connect
Intuy Knee
Instructions for Use (EN)
[Original Instructions]
Electronic Instructions for Use in different languages are available on the
Manufacturer's website (www.rbionics.com). Instructions for Use in paper
format can be requested from the website at no additional cost and shall be
delivered within 7 calendar days.
This document is subject to change, please contact the local Representative of
the Manufacturer or visit the Manufacturer's website to obtain the latest
version.

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
3 / 35
Reboocon Bionics B.V. Recover Boost Connect
TABLE OF CONTENTS
Table of Contents................................................................................................... 3
Terms and Abbreviations ....................................................................................... 6
Safety Warnings in this Document......................................................................... 6
General Warnings .................................................................................................. 6
1. Introduction ....................................................................................................... 9
1.1. Intended Use.............................................................................................. 9
1.2. Symbols Used on the Device and in this Document................................. 11
1.3. Product Labels.......................................................................................... 12
2. Product description.......................................................................................... 13
2.1. Dimensions (in Millimeters) and Description of Key Elements ................ 13
2.2. Product Model Identification ................................................................... 14
2.3. The Knee Cover ........................................................................................ 14
2.4. Scope of Delivery...................................................................................... 14
2.5. Product Technical Data ............................................................................ 14
3. Installation ....................................................................................................... 17
4. Mobile App for the Knee.................................................................................. 17
4.1. System Requirements on Mobile Devices................................................ 17
4.2. How to Obtain the App ............................................................................ 17
4.3. Personal Account for the App .................................................................. 17
4.4. The User Interface (UI) of the App ........................................................... 18
4.5. Software Update.................................................................................. 19
5. Preparation for Use.......................................................................................... 20
5.1 First Use and Hibernation Mode ............................................................... 20
5.2. Power On.................................................................................................. 20

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
4 / 35
Reboocon Bionics B.V. Recover Boost Connect
5.3. Power Off ................................................................................................. 21
5.4. Check Battery Status ................................................................................ 21
5.5. Charging the Device ................................................................................. 21
6. Default Modes and Routines............................................................................ 22
6.1. High-Resistance Mode (HR-mode) ........................................................... 22
6.2. Low-Resistance Mode .............................................................................. 22
6.3. Error Routine............................................................................................ 22
6.4. Battery Low Routine................................................................................. 23
7. Operation Instructions ..................................................................................... 23
7.1. From Sleep mode to Operation mode...................................................... 23
7.2. Standing State .......................................................................................... 23
7.3. Sitting Down and Standing Up.................................................................. 24
7.4. Walking .................................................................................................... 24
7.5. Descending Stairs and Ramps .................................................................. 25
7.6. Ascending Stairs ....................................................................................... 26
7.7. Kneeling Down and Getting Up ................................................................ 26
7.8. Cycling...................................................................................................... 27
8. Information Signals of the Device .................................................................... 28
9. Troubleshooting Guide .................................................................................... 30
10. Maintenance, Transportation, Storage, and Disposal.................................... 31
10.1. Manufacturer Maintenance................................................................... 31
10.2. User Maintenance and Cleaning ............................................................ 31
10.3. Transportation and Storage ................................................................... 32
10.4. Disposal.................................................................................................. 32
11. Warranty, Service Life, Liability, and Incident Reporting ............................... 32

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
5 / 35
Reboocon Bionics B.V. Recover Boost Connect
11.1. Warranty and Service Life ...................................................................... 32
11.2. Liability................................................................................................... 33
11.3. Serious Incident Reporting..................................................................... 33
12. Product Certification Information.................................................................. 33
12.1. EN-IEC 60601-1:2006+AC:2010+A1:2013+A12:2014 ............................. 34
12.2. EN-IEC 60601-1-2:2015 .......................................................................... 34
12.3. EN ISO 10328:2016................................................................................. 34
12.4. Bluetooth Module .................................................................................. 34
13. Contact Information....................................................................................... 34
13.1. Manufacturer ......................................................................................... 34
13.2. Distributor or Retailer ............................................................................ 35

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
6 / 35
Reboocon Bionics B.V. Recover Boost Connect
TERMS AND ABBREVIATIONS
EU
The European Union
HR-mode
High-resistance mode
IFU
Instructions for use
ILK
Intuy Knee
QMS
Quality Management System
RF
Radio Frequency
RH
Relative Humidity
UI
User Interface
SAFETY WARNINGS IN THIS DOCUMENT
WARNING: Statement regarding possible risks of severe accident or injury.
CAUTION: Statement regarding possible risks of accident or injury.
Precaution: Statement regarding possible damages to the device.
GENERAL WARNINGS
WARNING: Read this document carefully before using the device
independently.
WARNING: Practice operating the prosthesis in the presence of a trained
professional before using it independently. Start using the prosthesis
independently only when authorized to do so.
WARNING: Do not modify the product. Li-ion battery is inside. Fire or
explosion can occur and cause bodily damage. Any modification to the product
will void the warranty.
WARNING: Incorrect combination of components (e.g., the foot prosthesis)
can cause bodily damage.
WARNING: Follow the recommended maintenance intervals. Not maintaining
the product timely can cause damage to the device and the user, and will void
the warranty.
WARNING: Power off the prosthesis when performing tasks that may be
critical to your safety, such as driving a motor vehicle or operating other
potentially dangerous machinery.

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
7 / 35
Reboocon Bionics B.V. Recover Boost Connect
WARNING: Stop walking immediately whenever a signal is felt (prosthesis
vibrates) and/or heard (prosthesis beeps).
WARNING: Always use the handrail when traversing stairs or slopes. Do not
traverse stairs and slopes when handrails are not present.
WARNING: Use of components and cables other than those specified or
provided by the manufacturer could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result
in improper operation.
WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the Knee and the charger, including the supplied
cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
WARNING: It is not allowed to expose the device to strong electromagnetic
disturbances, e.g., to an MRI machine. The device might stop functioning when
exposed.
WARNING: It is not allowed to use the device in an oxygen-rich environment
or an area containing flammable (anesthetic) gases.
CAUTION: Keep body parts away from moving parts; moving parts may cause
injury.
CAUTION: Use the prosthesis at temperatures between –10°C and +40°C.
CAUTION: Charge the prosthesis at temperatures between 0°C and +40°C.
CAUTION: Power on the prosthesis only when you are wearing it.
CAUTION: Walk with the device only when it is powered on.
CAUTION: Do not apply loads higher than the specified rating.
CAUTION: Do not charge other devices with the charger!
CAUTION: Always exercise good judgment and common sense when using the
knee and components (e.g. the charger), limit their utilization to the use they
were designed for, and follow the instructions provided in this document.
CAUTION: Visually inspect the prosthesis before each use. Make sure that no
component of the prosthesis or accessories has been altered or tampered with.
CAUTION: If you experience any problems with a component of the prosthesis
or accessories, contact your prosthetist first. Never attempt to make any

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
8 / 35
Reboocon Bionics B.V. Recover Boost Connect
technical repairs yourself.
CAUTION: If the knee Cover needs to be replaced, contact your prosthetist.
Never attempt to remove the knee Cover by yourself.
Precaution: Avoid high-impact activity and sports, excessive loading, and heavy-
duty use.
Precaution: Avoid exposure to rain, snow, ice, or salt. Maintain and store in clean
and dry condition.
Precaution: Avoid exposure to intense dust or smoke or to excessive mechanical
shocks or vibrations.
Precaution: Avoid spillage or immersion in water or any other fluids.
Precaution: The charger is for indoor use only.

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
9 / 35
Reboocon Bionics B.V. Recover Boost Connect
1. INTRODUCTION
The Intuy Knee (hereafter referred to as the Device, the Knee, Joint, or ILK) is a
motorized external knee prosthesis designed to actively assist leg amputees in
performing daily activities. It is an active-power electromechanical device, which
is a component of an external lower limb prosthesis designed to functionally
replace, in part or total, an absent knee.
Please read this document thoroughly and discuss any questions with your
prosthetist before using this device. To ensure the safe and proper operation of
the device, you must follow the instructions provided in this document and
obtain sufficient training given by a professional.
1.1. INTENDED USE
According to EN ISO 14971:2019* cl. 3.6, Intended use and intended purpose are
interchangeable.
The device is intended to actively assist above-knee amputees and hip- or knee-
disarticulation individuals in performing daily activities such as
•standing
•walking
•stair and slope ascending and descending
•sitting down and standing up
•kneeling
The mobile app is used to adjust the settings and switch the operational modes
of the device.
Intended Population
The intended user group is summarized below.
•Clinical status: (unilateral or bilateral) knee disarticulation,
transfemoral amputation, and hip disarticulation.
•Bodyweight: Between 25 and 125 kg
•Body height: Between 1.20 and 1.95m
•Age: No specific requirement is indicated. It should be evaluated based
on the physical and mental conditions of the user by care providers.
Intended User Profile
The device is intended for amputees with moderate to high activity levels.
This device is installed and customized by a qualified prosthetist. Prosthetists

Instructions for Use (Wearer)
DOC-66
Basic UDI-DI: 87202994598ILK98
Ver. 2.0.7, 2022/11/04
10 / 35
Reboocon Bionics B.V. Recover Boost Connect
become the user when integrating the device to construct a leg prosthesis and
adjust settings for the amputees.
Intended Medical Indication
The device is indicated for individuals with (unilateral or bilateral) knee
disarticulation, transfemoral amputation, and hip disarticulation. The individual
must fulfill the physical and mental requirements for perceiving visual/acoustic
signals and/or mechanical vibrations.
Limitations and Contraindications
Bilateral amputees might not be able to perform all the activities indicated in this
document, such as step-over-step stair ascent or cycling.
There is not enough clinical data to encourage or discourage the use of the
device for users with osseointegration.
Similarly, there is not enough clinical data to encourage or discourage the use of
the device for patients with low mobility levels.
Due to possible socket stability issues, a patient with a short stump might not
enjoy all the benefits of the device, e.g., step-over-step stair climbing. However,
a patient with a short stump is not discouraged to use this device.
Currently, there is no known contraindication.
Part of the Body Interacted with
Via a prosthetic socket, the device shall be connected to the residual limb of the
user. The prosthetic socket is mostly made of non-conducting plastics. Very
often, the user also puts on a silicon or other non-conductive material-based
liner before putting it on the socket.
The user will only shortly touch the device when donning the prosthetic leg
on/off, power on/off the device, and (dis-)connecting the charger cable.
Besides that, there is no direct contact during use.
Intended Use Environment
The device actively assists amputees in performing daily activities in Home
Healthcare Environment (see EN-IEC 60601-1-11:2015), the device will be used
both indoors and outdoors.
•Temperature range: -10°C to 40°C
•Humidity: 0% to 90% RH, non-condensing
•Air pressure: 700-1060hPa
The charger is to be used indoors only.
•Temperature range: 0°C to 40°C
•Humidity: 0% to 90% RH, non-condensing