Related Manuals for Otto Bock Bionic Pro
Summary of Contents for Otto Bock Bionic Pro
- Page 1 743A250 Bionic Pro Instructions for use ....................
- Page 2 743A250 Bionic Pro...
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Page 3: Table Of Contents
........................... 5.5.8.3.2 10 metre gait analysis .......................... 5.5.8.4 Making analysis files available ......................Updating product components ......................5.6.1 Updating the router ..........................5.6.2 Updating the base station ........................5.6.3 Updating the iPad ..........................5.6.4 Updating the sensors .......................... 743A250 Bionic Pro... - Page 4 Resetting frozen user interface (timeout) ....................5.7.4 Replacing faulty product components ....................Switching off ............................Cleaning ................................Disposal ................................Legal information .............................. Liability .............................. CE conformity ............................. Trademarks ............................Local Legal Information ........................Symbols Used ..............................Technical data ..............................743A250 Bionic Pro...
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Page 5: Notes Regarding The Document
The illustrations used in this document show the tablet and the user interface in simplified form. Technical changes may result in deviations in the hardware (e.g. appearance and layout of control elements and connections) and the software (e.g. user interface). 743A250 Bionic Pro... -
Page 6: Explanation Of Warning Symbols
Operating the product outside of the permissible temperature range Limited function due to product malfunction or damage ► Avoid operation in areas outside the permissible temperature range. Operating temperature 10–40 °C Ambient temperature for char 0–45 °C ging Relative humidity 30%–70% 743A250 Bionic Pro... -
Page 7: Product Description
: Case General functionality The Bionic Pro is suitable for conducting analyses on adults and children aged 12 years and up who are able to stand in the neutral zero position and to make full ground contact with their feet while walking. -
Page 8: Scope Of Delivery
743A250 Bionic Pro functionality (10 metre gait analysis) The 743A250 Bionic Pro in conjunction with the 10 metre gait analysis is intended for gait analysis in order to use the measurement results to provide objective evidence of how a device (orthosis/prosthesis) affects the gait pat... -
Page 9: Checking The Scope Of Delivery
: 1x 743Y827=V1 : 1x 757L42=V1 Ubiquiti Amplifi Instant Router (AFi-INS) US universal power supply for 743Y827=V1 : 1x 743Y832=V1 : 1x 646D1448=ALL_INT Plastic card with access data for Bionic Pro Bionic Pro “Kurzanleitung/Quick reference guide” : 1x : 1x 647G1361=DE_INT Supplier documentation (iPad, Ubiquiti AmpliFi Instant Instructions for use (German) Router) : 1x 647G1361=EN_INT... -
Page 10: Preparing The Product For Use
The “Setting up the iPad” (see page 16) section is needed when preparing the product for use for the first time. ► Follow the sections in order so the product components can connect with one another properly via WLAN. 743A250 Bionic Pro... -
Page 11: Connecting The Ipad To The Power Supply
(type A (NEMA-1)) for outlets of type A (NEMA-1) and type B (NEMA-5). ► For other types of outlets, use an adapter from a specialist shop which is suitable for the connected loads of the power supply (100–240 V/50–60 Hz). ► Connect the iPad to the power supply for charging. 743A250 Bionic Pro... -
Page 12: Connecting The Router To The Power Supply
→ The WLAN is ready for the iPad, the base station and the sensors after a few minutes (approx. 2 min). INFORMATION The router has a touch screen. Various information on the router can be displayed by tapping the touch screen. It cannot be used to modify settings. 743A250 Bionic Pro... -
Page 13: Connecting The Router To The Internet
Internet once each day so updates can be performed. ► Plug the LAN cable into the customer’s Internet connection and the Bionic Pro router. INFORMATION: A WLAN connection is not intended to be established between the Bionic Pro router and the customer’s Internet connection. -
Page 14: Connecting The Base Station To The Power Supply
► For other types of outlets, use an adapter from a specialist shop which is suitable for the connected loads of the power supply (100–240 V/50–60 Hz). ► Connect the base station to the power supply. → The base station is ready after a few minutes (approx. 5 min) when the three status LEDs on the front are illuminated continuously. 743A250 Bionic Pro... -
Page 15: Charging Sensors In The Base Station And Switching Them On Prior To Measuring
WLAN connection to router Boot process completed, established base station ready Flashing slowly WLAN connection to router interrupted, base station set ting up own WLAN network Flashing quickly WLAN connection to router Base station booting being established 743A250 Bionic Pro... -
Page 16: Switching On The Ipad
QR codes: : DE (German) – https://support.apple.com/de-de/guide/ipad/ipad995bb83d/ipados : EN (English) – https://support.apple.com/en-gb/guide/ipad/ipad995bb83d/ipados ► Refer to the “Scanning the QR code” (see page 21) section to use the QR code. ► Follow the instructions on the iPad screen when setting it up. 743A250 Bionic Pro... -
Page 17: Use
→ If this does not remedy the faults, switch off all other high-frequency devices. → If this does not remedy the faults, use the product in a different room. → If this does not remedy the faults, contact the manufacturer. 743A250 Bionic Pro... -
Page 18: General Information On The Use Of The Ipad
Apps and links that cannot be displayed on the home screen are shown on other pages which can be reached by swiping horizontally. Apps and links that are found in the dock are displayed on both the home screen and the additional pages. 743A250 Bionic Pro... -
Page 19: Important Apps
5.3.3 Important links The following links are important for use: : Bionic Pro – tapping the link opens the Safari browser and displays the login page for the Bionic Pro user inter face. : Router update – tapping the link opens the Safari browser and displays the update page for the user interface of the router. -
Page 20: Taking Screenshots
: The app toggle displays all the open apps. → Tapping an app switches to the selected app. → Swiping up closes the relevant app. → You can switch to the home screen by clicking the home button. 743A250 Bionic Pro... -
Page 21: Scanning Qr Codes
: Start the “Camera” app. ► ► : Position the camera so the website QR code is in the viewfinder . ► : Tap the “Website QR code – open ‘1234567.bionicpro.local‘ in Safari” button to open the link in the Safari browser. 743A250 Bionic Pro... -
Page 22: Attaching The Sensors To The Patient
Skin irritation, formation of eczema or infections due to contamination with germs ► The product may only be used on another person after thorough cleaning and disinfection. ► Clean the product regularly ("Cleaning" section – see page 41). 743A250 Bionic Pro... - Page 23 Positioning: lateral at the position with the largest circumference; thigh and calf sensor aligned on the same axis FL (foot left), FR (foot right): left foot, right foot Positioning: sensor holder centred on the hindfoot right over the sole of the shoe; plastic tongue under the shoelaces 743A250 Bionic Pro...
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Page 24: Notes Regarding The Initialization Of The Sensors Before A Measurement
5.5.1 Optimal display of the user interface 100 % 100 % 1234567.bionicpro.local 1234567.bionicpro.local Bionic Pro start page Bionic Pro start page Welcome! For which customer do you want to perform an analysis? Welcome! For which customer do you want to perform an analysis? -
Page 25: Accessing The User Interface
Support Bionic Pro The user interface is opened in the Safari browser after tapping the “Bionic Pro” link. The first time the user interface is used, the “Market” is selected under “Select your market” and the “Language” is selected under “Select your language”, followed by tapping the “Continue” button. -
Page 26: Homepage
5.5.3 Homepage 100 % 1234567.bionicpro.local Bionic Pro start page Welcome! For which customer do you want to perform an analysis? Existing customer customer Existing customer customer Enter user name The homepage includes the following buttons: : “Existing customer” – use this icon to start an analysis with an existing customer. -
Page 27: Settings
The instructions for use are displayed in the language set under “Adjust settings” (see page 28). The digital version may also be printed out. The icon can be used to close the tab. 743A250 Bionic Pro... -
Page 28: System Information
: System of units (metric system / imperial system) : Market (EU / USA) – an FES application is only possible if “EU” is selected in combination with a suitable orthosis. : Company information - For entering company information in order to show it on the PDF reports. 743A250 Bionic Pro... -
Page 29: Customer Overview
The data protection laws for the respective country of use must be observed when using the customer view (customer file). 5.5.7 Creating and selecting users 100 % 1234567.bionicpro.local Bionic Pro start page Welcome! For which customer do you want to perform an analysis? Enter user name Existing... -
Page 30: Performing An Analysis
According to data protection law, the customer has to consent to data processing. Either a paper form or the declaration of consent stored in Bionic Pro can be used for this purpose. After filling in all fields and reading the declaration of consent, the consent can be signed by the customer in the field provided (for example using their finger). -
Page 31: Existing Customer
Further details regarding this can be found in the iPad user manual (link in the “General informa tion on the use of the iPad” section – see page 18). This section describes how the files can be sent from the Safari browser via e-mail or alternatively saved on the iPad. PDF files 743A250 Bionic Pro... - Page 32 PDF file as an attachment. Alternatively, the PDF file can be saved on the iPad by tapping the “Save to files” icon and forwarded (e.g. via USB cable). 743A250 Bionic Pro...
- Page 33 Alternatively, the video file can be saved on the iPad by tapping the “Save to files” icon and forwarded (e.g. via USB cable). 743A250 Bionic Pro...
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Page 34: Updating Product Components
The operating system and the iPad apps should be updated to the latest version when updates are available to ensure the best possible security and functionality. Further information on the updates is available in the iPad user manual. 743A250 Bionic Pro... -
Page 35: Updating The Sensors
: Confirm the displayed message with “OK” and wait until the firmware update has been installed on the sensors. 5.7 Troubleshooting The following subsections contain further information on eliminating errors: • “User interface system messages” (see page 36) • “Fault table” (see page 37) • “Measures” (see page 39) • “Replacing faulty product components” (see page 40) 743A250 Bionic Pro... -
Page 36: User Interface System Messages
Take the following steps for the “Low sensor battery level” error message: ► Insert the sensor in the base station for charging (“Charging sensors in the base station and switching them on prior to measuring” – see page 15). ► Once the sensor is charged, tap the “OK” button. 743A250 Bionic Pro... -
Page 37: New Firmware For Sensor" System Message
(white) Centre LED on base station flashing rapidly iPad connected to wrong WLAN Connect iPad to the WLAN of the Bionic Pro router Identified by: Tablet is not connected to Bionic Pro router in WLAN settings Base station switched off... - Page 38 Sensor not charged despite pre vious steps Base station not switched on Switch base station on User interface working at slower Interference due to other HF Refer to the instructions in the pace devices “Preventing electromagnetic interference” section (see page 17) 743A250 Bionic Pro...
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Page 39: Measures
“Preventing electromagnetic interference” section (see page 17). 5.7.3.2 Resetting frozen user interface (timeout) 100 % 100 % 1234567.bionicpro.local 1234567.bionicpro.local Bionic Pro start page Welcome! For which customer do you want to perform an analysis? Welcome! Please log in with your PIN: ••••••... -
Page 40: Replacing Faulty Product Components
If product components are defective, it is important to contact the service team to determine which product com ponents should be sent in for repair. This applies to the interdependent components of the product (base station, router, iPad and sensors) in particular. 5.8 Switching off Switch off the product components according to the illustration. 743A250 Bionic Pro... -
Page 41: Cleaning
In some jurisdictions it is not permissible to dispose of the product with unsorted household waste. Improper dis posal can be harmful to health and the environment. Observe the information provided by the responsible authorit ies in your country regarding return, collection and disposal procedures. 743A250 Bionic Pro... -
Page 42: Legal Information
The following directives are confirmed by the manufacturers of the respective product components of the 743A250 Bionic Pro (Ottobock: base station and sensors; Apple: iPad; Ubiquiti Networks: router): The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain haz... - Page 43 RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website http://www.hc-sc.gc.ca/rpb. Responsible party: Otto Bock Healthcare Canada Ltd. 5470 Harvester Road L7L 5N5 Burlington, Ontario Canada Phone + 1-800-665-3327 Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device.
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Page 44: Symbols Used
Please observe the instructions of your national authority pertaining to return and collection. Please note the instructions for use Non-ionising radiation Compliance with the requirements under "FCC Part 15" (USA) Class II Electrical device Type BF applied part Medical device 743A250 Bionic Pro... -
Page 45: Technical Data
Directives and manufacturer’s declaration – electromagnetic interference The 743A250 Bionic Pro product is designed for operation in an electromagnetic environment as specified below. The customer or user of the 743A250 Bionic Pro product must ensure that the device is operated in such an environment. - Page 46 To determine the electromagnetic environment with regard to stationary transmitters, a study of electromagnetic phenomena at the site should be considered. If the measured field strength at the location where the 743A250 Bionic Pro product is used exceeds the above compliance level, the 743A250 Bionic Pro product 743A250 Bionic Pro...
- Page 47 Technical data should be monitored to confirm it is functioning as intended. If unusual performance characteristics are observed, additional measures may be required such as repositioning the 743A250 Bionic Pro product or moving it to a dif ferent location. Within the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V...
- Page 48 Test frequencies with which the product has been tested Test fre Frequency Mobile com Modulation Maximum Distance Interference quency band munications output immunity lim (MHz) (MHz) standard it values (V/m) RFID 2450, LTE band 7 5,240 5,100–2,570 WLAN 802.11 Pulse modula tion 5,500 217 Hz 5,785 743A250 Bionic Pro...
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- Page 52 Ottobock SE & Co. KGaA Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 848-3360 healthcare@ottobock.de · www.ottobock.com...