Reboocon Bionics Intuy Knee User manual

Instructions for Use (Wearer)
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Intuy Knee
Instructions for Use (EN)
[Original Instructions]

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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.

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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

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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

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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

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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.

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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

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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.

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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

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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

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•Air pressure: 700-1060hPa
Reasonably Foreseeable Misuse
The foreseeable misuses are listed below.
•The user exposes the device to rain, snow, ice, and salt.
•The device is subject to spillage or immersion in water or any other
fluids, e.g., taking a shower while wearing the device
•The user exposes the device to intense dust.
•The user exposes the device to excessive mechanical shocks or
vibrations.
•Use in highly electrical and/or magnetic environments (e.g., electrical
transformers, high-power radio/TV transmitters).
•The user uses the device for high-impact activities and sports.
1.2. SYMBOLS USED ON THE DEVICE AND IN THIS DOCUMENT
Maximum user weight (125kg)
Caution: danger! Keep body parts such as fingers away
Medical device
Caution: consult the Instructions for Use
Manufacturer information
Year of manufacturing
Direct Current
Power button
Non-ionizing radiation
CE label
Serial number
Model number
Protection against>1 mm particles, protection against water jets
Follow Instructions for Use

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The product should not be discarded as unsorted waste but must be
sent to separate collection facilities for recovery and recycling. Please
observe the instructions in this document.
Distributor
NOTE: To see some of the symbols used on the device, please remove the Knee
Cover carefully. Removal of the cover shall be done by qualified personnel such
as your prosthetist.
1.3. PRODUCT LABELS
Labels are present on the Device and the Charger. Device labels are laser
engraved onto the metal frame and Charger labels are stickers.
Device Label
Charger Label

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2. PRODUCT DESCRIPTION
2.1. DIMENSIONS (IN MILLIMETERS)AND DESCRIPTION OF KEY ELEMENTS
Key functional elements of the device are shown in the figure above and listed
below (note: the knee Cover is removed for clarity):
A. Top pyramid, a standard prosthetic interface for connecting to thigh
socket.
B. The Knee body, consists of the following components: the frame, the
battery, the electronics, and the actuator unit.
C. Bottom pyramid, a standard prosthetic interface for connecting to the
tube adapters.
On the device body, the following elements can interact with the user
D. A dual-color (amber/green) LED set to indicate the working status of
the device;
E. Bluetooth for communicating with smartphones;
F. A power button, to power on and off the device.;
G. A buzzer, together with the LEDs to indicate the status of the device;
H. A charging port, a standard USB-C receptacle connector;
I. The Knee Axis marks on both sides for prosthetic alignment.

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2.2. PRODUCT MODEL IDENTIFICATION
There are two models: ILK-1B and ILK-1W (see label on the device). ILK-1B refers
to the black model and ILK-1W refers to the silver model. There is no other
difference besides color. In some countries, only one model is available.
2.3. THE KNEE COVER
The Knee comes with a protective cover, which has the following functions:
•Protects the device from debris and dust
•Protects the user's fingers from pinching hazards (refer to General
Warnings)
•Slightly reduces the noise
The cover must be replaced if it's worn out, damaged, or broken. Contact your
prosthetist to get a replacement.
2.4. SCOPE OF DELIVERY
The following components are delivered:
•1 pc. Knee device
•1 pc. Battery charger (including 1 pc. C7 power cord, ILKCH)
•1 pc. Instructions for use (Wearer)
•1 pc. USB stick
•1 pc. T-wrench
•1 pc. Knee cover
•Android/IOS app Intuy
2.5. PRODUCT TECHNICAL DATA
Environmental Conditions
Transportation in original
packaging
0°C to 40°C, max.90% RH, non-condensing
Transportation without packaging
0°C to 40°C, max.90% RH, non-condensing
Storage (≤3 months)
0°C to 40°C, max.90% RH, non-condensing
Long-term storage (>3 months)
0°C to 20°C, max.90% RH, non-condensing
Operation
-10°C to 40°C, max.90% RH, non-condensing

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Charging the battery
0°C to 40°C, max.90% RH, non-condensing
Intuy Knee device
Weight
2.4 kg
Range of motion
Max flexion 120°, max extension 0°
Maximum output torque
100Nm
Maximum output power
600W
Protection rating
IP45 (protection against >1 mm particles
& water jets)
Range of Bluetooth connection
Max. 10 m
Bluetooth RF receiver
Frequency band: 2.4 GHz. Bandwidth: 83.5
MHz
Bluetooth RF transmitter
Frequency band: 2.4 GHz. Modulation:
GFSK. Power: 8 dBm
Battery (built-in, non-removable)
Battery type
Li-ion
Battery nominal voltage
28.8 VDC
Battery Capacity
3.0 Ah
Battery Energy
86.4 Wh
Nominal charging current
2.1 A
Rated (max) charging current
2.4 A
Full charge voltage
33.6 VDC
Battery fuse rating (rated voltage, rated current,
interrupting rating)
35 VDC, 40 A, 300 A
Charging cycles (80% original battery capacity remaining)
500

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Product behavior when charging
Disabled
Operating autonomy
44h use-dependent
Battery charger
Model number
LYD703362000
Weight
0.27 kg
Dimensions
12 cm x 3.7 cm x 5.4 cm
Rated input voltage
100 - 240 VAC
Input frequency
50/60 Hz
Max input current at rated input
voltage
1.5 A
Output voltage (end-of charge)
33.6 VDC ±1%
Rated charge current
1.78 A ±10%
Supply cord length (a.c. port)
0.8 m
Storage & transport environment
0°C to 40°C, max.90% RH, non-condensing
Operation environment
0°C to 40°C, max.90% RH, non-condensing
Protection rating
IP20
Structural Strength (tested according to EN-ISO 10328: 2016)
Load Level
P6, max. 125kg
Fatigue strength (3 million cycles)
150kg
Static proof strength
250kg
Ultimate strength
400kg

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Static strength in torsion (30s)
50Nm
Static ultimate strength in max. knee flexion
175kg
3. INSTALLATION
Installation of the Knee is not meant to be executed by the patient. Installation is
only done by qualified personnel.
For the Installation Instructions, refer to DOC-68 Instructions for Use
(Practitioner).
4. MOBILE APP FOR THE KNEE
4.1. SYSTEM REQUIREMENTS ON MOBILE DEVICES
•Operating system: Android 10.0 or above, iOS 13.6 or higher
•RAM: 2 GB or more
•Internal Storage: 10 MB for app installation/ 1024 MB for diagnostic
data storage
•Bluetooth: Bluetooth 4.0 or higher
•Screen: touch screen, 4 inches or bigger
•Network: WiFi or mobile network enabled
4.2. HOW TO OBTAIN THE APP
Search for "Intuy by Reboocon" in the Play Store on an Android device or App
Store on an Apple device and install it. The app will be made available to more
app stores. Alternatively, use this link: https://www.rbionics.com/app/.
4.3. PERSONAL ACCOUNT FOR THE APP
It is required to have a personal account to use the app. The account is invitation
based. The Manufacturer or the local Representative of the Manufacturer should
send an invitation to the potential users (both professional and end users).
Instructions about logging in are given in the (email) invitation. After logging in,
the app can be used.
Different user accounts have different authorization levels. The higher the
authorization level, the more app features the user can access. With a personal

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account, the user can connect to a Knee authorized to him/her and store
personalized settings on the app server.
4.4. THE USER INTERFACE (UI) OF THE APP
The DASHBOARD tab (the main UI) is shown in the left picture above. The key
elements:
A. Menu button: when clicked, the picture on the right shows up. It has
a return button (I) and you can see the app version (K). When
clicking the individual Menu Items (J), diverse pages for different
purposes pop up:
oUpdate: manage Knee firmware update and app update;
oDevice management *: manage all the devices authorized
to you, e.g., authorizing others to use the device in the list;
oUser management *: manage all the users under your
authorization;
oStatistics: check the daily and total steps, stairs count, etc.;

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oApp settings: e.g., change the server settings or other
settings of the app;
oMy account: manage your own account information, e.g.,
change password or email;
oLog out button.
B. Notification Center: it shows error messages or notifications such as
software updates or periodic maintenance deadlines.
C. Device Status: It indicates the current mode of the device, such as
cycling or sitting.
D. Mode Switching Buttons, from left to right:
oSTART: switch the Knee to operational mode, the user can
walk with the Knee;
oSLEEP: switch the Knee to sleep mode, the motor of the
Knee is shut down, and no support is given;
oLOCK KNEE: fully extend the Knee and lock it.
E. Function tabs: each tab has its own function, with its contextual
buttons and fields. From left to right:
oDASHBOARD: this shows the dashboard, as shown in the
picture on the left;
oSETTINGS: here patient data can be set and sent to the
Knee, such as body weight, height, and segment lengths;
oEXTRA *: here extra parameters for walking, stairs, etc.
can be customized, if the default settings are not ideal;
oGRAPH *: it shows the knee torque, knee angle, etc. in
real-time;
oSUPPORT: data from the Knee and app use are collected
and can be sent to the Manufacturer's server for
troubleshooting purposes;
F. Bluetooth: a new page will pop up when clicked to allow the user to
connect or disconnect to a Knee.
G. ILKyymmxxx: it shows the serial number of the device.
H. Battery: battery level.
* Not available for the patient.
4.5. SOFTWARE UPDATE
The app checks whether the app itself or the firmware in the Knee is up-to-date.

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To update, click the item Update in the Menu. On the update page, click the
update button if an update is available. An app update is straightforward and
relatively quick. A firmware update typically takes 5 to 20 minutes. Don't
perform any other activities on the phone. If the firmware update fails, retry
according to the app's instructions.
WARNING: Sit down or doff the prosthesis when performing the Knee
firmware update. Don't use the Knee.
WARNING: After the firmware update, the Knee is in sleep mode, and the user
is required to load the prosthesis sufficiently (>50% bodyweight) before making
the first step.
WARNING: Make sure that the phone has more than 20% charge and that the
Knee has more than 40% charge. Keep the Knee and the phone close to each
other during the update process.
5. PREPARATION FOR USE
5.1 FIRST USE AND HIBERNATION MODE
Before leaving the factory, the knee is put into Hibernation Mode. To get out of
Hibernation Mode, the knee must be charged once. It is not possible to enter
Hibernation Mode unless the battery goes extremely low.
5.2. POWER ON
Press and hold the Power Button for 3s, until the buzzer beeps and the green LED
flashes. The device then enters Sleep Mode. Load the device by putting half of
the body weight on the prosthesis to enter the Operation Mode.
Precaution: Do not hold the Power Button longer than 15 seconds, the knee can
be damaged.
CAUTION: Load the prosthesis sufficiently before standing up or walking. The
device does not provide support when powered off, or in sleep mode. Sufficient
loading on the device activates the support.
CAUTION: The knee will enter Sleep Mode if it is standing still and unloaded
for 10 minutes. This transition will be indicated with 3 descending beep tones
and 1 vibration.