Summary of Contents for Reboocon Bionics Intuy Knee
- Page 1 Instructions for Use (Wearer) DOC-66 Basic UDI-DI: 87202994598ILK98 Ver. 2.0.7, 2022/11/04 1 / 35 Intuy Knee Instructions for Use (EN) [Original Instructions] Reboocon Bionics B.V. Recover Boost Connect...
- Page 2 Instructions for Use (Wearer) DOC-66 Basic UDI-DI: 87202994598ILK98 Ver. 2.0.7, 2022/11/04 2 / 35 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.
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Page 3: Table Of Contents
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 Reboocon Bionics B.V. Recover Boost Connect... - Page 4 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 Reboocon Bionics B.V. Recover Boost Connect...
- Page 5 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 Reboocon Bionics B.V. Recover Boost Connect...
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Page 6: Terms And Abbreviations
Ver. 2.0.7, 2022/11/04 6 / 35 ERMS AND BBREVIATIONS The European Union HR-mode High-resistance mode Instructions for use Intuy Knee Quality Management System Radio Frequency Relative Humidity User Interface AFETY ARNINGS IN THIS OCUMENT WARNING: Statement regarding possible risks of severe accident or injury. - Page 7 CAUTION: If you experience any problems with a component of the prosthesis or accessories, contact your prosthetist first. Never attempt to make any Reboocon Bionics B.V. Recover Boost Connect...
- Page 8 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. Reboocon Bionics B.V. Recover Boost Connect...
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Page 9: Introduction
1. I NTRODUCTION 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. - Page 10 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 Reboocon Bionics B.V. Recover Boost Connect...
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Page 11: Symbols Used On The Device And In This Document
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 Reboocon Bionics B.V. Recover Boost Connect... -
Page 12: Product Labels
1.3. P RODUCT ABELS 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 Reboocon Bionics B.V. Recover Boost Connect... -
Page 13: Product Description
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. Reboocon Bionics B.V. Recover Boost Connect... -
Page 14: Product Model Identification
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 Reboocon Bionics B.V. Recover Boost Connect... - Page 15 Instructions for Use (Wearer) DOC-66 Basic UDI-DI: 87202994598ILK98 Ver. 2.0.7, 2022/11/04 15 / 35 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...
- Page 16 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 Reboocon Bionics B.V. Recover Boost Connect...
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Page 17: Installation
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 Reboocon Bionics B.V. Recover Boost Connect... -
Page 18: The User Interface (Ui) Of The App
Device management *: manage all the devices authorized to you, e.g., authorizing others to use the device in the list; User management *: manage all the users under your authorization; Statistics: check the daily and total steps, stairs count, etc.; Reboocon Bionics B.V. Recover Boost Connect... -
Page 19: Software Update
ILKyymmxxx: it shows the serial number of the device. Battery: battery level. * Not available for the patient. 4.5. OFTWARE PDATE The app checks whether the app itself or the firmware in the Knee is up-to-date. Reboocon Bionics B.V. Recover Boost Connect... -
Page 20: Preparation For Use
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. Reboocon Bionics B.V. Recover Boost Connect... -
Page 21: Power Off
CAUTION: Do not use the device when it is charging, as it does not provide support when charging. CAUTION: Do not keep the device battery fully charged when it is not in use for an extended period. Reboocon Bionics B.V. Recover Boost Connect... -
Page 22: Default Modes And Routines
If the knee is in the swing phase, the knee will extend and then go to HR-mode. The extension speed of the error routine is slower than normal. • If the knee is in the stance phase, the knee will directly enter the HR- mode. Reboocon Bionics B.V. Recover Boost Connect... -
Page 23: Battery Low Routine
When none of these activities is detected, it operates in a “standing state”. In this state, common day-to-day tasks can be performed, like talking to people, reaching the shelf, and cooking in the kitchen. Reboocon Bionics B.V. Recover Boost Connect... -
Page 24: Sitting Down And Standing Up
By default, the knee extends to a preflexion angle of 4° at the end of the swing phase. The benefit of a preflexion angle is two-fold: It provides symmetric and natural gait in the stance phase. It provides increased shock absorption that reduces stress on the back. Reboocon Bionics B.V. Recover Boost Connect... -
Page 25: Descending Stairs And Ramps
CAUTION: Due to the knee torque being limited to 100Nm, the support for users above 80kg will not be sufficient during descent. Additional support is Reboocon Bionics B.V. Recover Boost Connect... -
Page 26: Ascending Stairs
Place the prosthetic leg at the back and bend the knee to kneel on the prosthetic side, loading the prosthesis during the whole process. Proceed to kneel on the sound side knee. Turn about the knee on the sound side to sit on the floor. Reboocon Bionics B.V. Recover Boost Connect... -
Page 27: Cycling
Start pedaling, after 2-3 crank rotations the Intuy Knee will start to power a portion of the rotation assisting the user. When taking a pause, the device will have higher flexion resistance. -
Page 28: Information Signals Of The Device
Not Charging --> Turns on Turns Off charging Not charged --> fully Turns off Turns on charged Charger plugged in -- Turns off Turns off >Charger unplugged Battery level ok --> 4 vibrations Battery overcharged Reboocon Bionics B.V. Recover Boost Connect... - Page 29 Fast flashing Slow flashing 8s beeping 8 vibrations error detected Mode change from 3 beeps the app Maintenance deadlines 15s beeping 15 vibrations approaching (60 and 30 days) Maintenance deadline within 15 15s beeping 15 vibrations days Reboocon Bionics B.V. Recover Boost Connect...
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Page 30: Troubleshooting Guide
Contact your prosthetist to re-calibrate the calibration of the despite the sensors sensor correct user cue Error message in the app; the knee Errors are Contact your prosthetist vibrates and detected makes sounds Reboocon Bionics B.V. Recover Boost Connect... -
Page 31: Maintenance, Transportation, Storage, And Disposal
(see the figure). And allow it to air dry fully. CAUTION: If the device is not dried after being immersed in water, it may result in hardware degradation and introduce risks. Reboocon Bionics B.V. Recover Boost Connect... -
Page 32: Transportation And Storage
Performing maintenance timely can increase the service life to 6 years. An extended warranty can be purchased separately. Contact your prosthetist for purchasing instructions. The following are not covered by the warranty: • Repairs resulting from misuse, careless handling, or intentional damage. Reboocon Bionics B.V. Recover Boost Connect... -
Page 33: Liability
The product complies with European regulations such as Regulation (EU) 2017/745 (MDR) and has obtained the CE mark after being assessed by a notified body. The manufacturer's Quality Management System (QMS) is certified according to Regulation (EU) 2017/745 (MDR) and EN ISO 13485:2016+C11:2017+C12:2018+A11:2021. Reboocon Bionics B.V. Recover Boost Connect... -
Page 34: 12.1. En-Iec 60601-1:2006+Ac:2010+A1:2013+A12:2014
– Collateral Standard: Electromagnetic disturbances – Requirements and tests). 12.3. EN ISO 10328:2016 Intuy Knee is tested and rated to P6 level for 125kg maximal body weight according to EN ISO 10328:2016. 12.4. B... -
Page 35: Distributor Or Retailer
Ver. 2.0.7, 2022/11/04 35 / 35 13.2. D ISTRIBUTOR OR ETAILER The Distributors or Retailers of the Product shall place their contact information sticker below. The user should always contact them first before contacting the Manufacturer. Reboocon Bionics B.V. Recover Boost Connect...
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