Otto Bock 743A250 User manual

743A250 Bionic Pro
Instructions for use ............................................................................................... 3

2 743A250 Bionic Pro

Notes regarding the document1 5..........................................................................................................................
Meanings of pictograms in the illustration1.1 5................................................................................................
Illustration of the tablet and the user interface of the operating system1.2 5.........................................................
Explanation of warning symbols1.3 6..............................................................................................................
General safety instructions1.4 6.....................................................................................................................
Product description2 7............................................................................................................................................
Scope of delivery3 8.................................................................................................................................................
Removing the product components from the case3.1 8.....................................................................................
Checking the scope of delivery3.2 9...............................................................................................................
Preparing product for use4 10................................................................................................................................
Connecting the iPad to the power supply4.1 11...............................................................................................
Connecting the router to the power supply4.2 12.............................................................................................
Connecting the router to the Internet4.3 13.....................................................................................................
Connecting the base station to the power supply4.4 14....................................................................................
Charging switched off sensors in the base station and switching them on prior to measuring4.5 15.......................
Switching on the iPad4.6 16..........................................................................................................................
Setting up the iPad4.7 16..............................................................................................................................
Use5 17......................................................................................................................................................................
Switching on5.1 17......................................................................................................................................
Preventing electromagnetic interference5.2 17................................................................................................
General information on the use of the iPad5.3 18.............................................................................................
Home screen and dock5.3.1 18........................................................................................................................
Important apps5.3.2 19...................................................................................................................................
Important links5.3.3 19....................................................................................................................................
Taking screenshots5.3.4 20.............................................................................................................................
Using the app toggle5.3.5 20...........................................................................................................................
Scanning QR codes5.3.6 21............................................................................................................................
Scanning the WLAN QR code5.3.6.1 21..............................................................................................................
Scanning the website QR code5.3.6.2 21.............................................................................................................
Attaching the sensors to the patient5.4 22.......................................................................................................
Using the user interface5.5 24.......................................................................................................................
Optimal display of the user interface5.5.1 24......................................................................................................
Accessing the user interface for the first time5.5.2 24..........................................................................................
Accessing the user interface5.5.3 25.................................................................................................................
Homepage5.5.4 25.........................................................................................................................................
Setup and help5.5.5 26...................................................................................................................................
Settings5.5.6 26.............................................................................................................................................
Instructions for use5.5.6.1 27..............................................................................................................................
System information5.5.6.2 27..............................................................................................................................
Adjusting the settings5.5.6.3 28..........................................................................................................................
Imprint5.5.6.4 28...............................................................................................................................................
Privacy notice5.5.6.5 28.....................................................................................................................................
Contact and service5.5.6.6 29............................................................................................................................
Customer overview5.5.7 29..............................................................................................................................
Creating and selecting users5.5.8 29................................................................................................................
Drop foot fitting5.5.9 30...................................................................................................................................
Existing customer5.5.9.1 30................................................................................................................................
New customer5.5.9.2 30....................................................................................................................................
Neurological status5.5.9.3 31.............................................................................................................................
Assessment preparation5.5.9.4 31.......................................................................................................................
Sensor setup when measuring without an orthosis5.5.9.5 31..................................................................................
Measuring without an orthosis5.5.9.6 32..............................................................................................................
Sensor setup when measuring with an orthosis5.5.9.7 33.......................................................................................
Table of contents
3743A250 Bionic Pro
Table of contents

Measuring with an orthosis5.5.9.8 33...................................................................................................................
Completing the drop foot fitting assessment5.5.9.9 35...........................................................................................
Save orthosis for customer5.5.9.10 35...................................................................................................................
Applying for FES cost coverage5.5.9.11 35............................................................................................................
Creating a PDF report5.5.9.12 36.........................................................................................................................
Making assessment files available5.5.9.13 36.........................................................................................................
Updating product components5.6 38..............................................................................................................
Updating the router5.6.1 38.............................................................................................................................
Updating the sensors5.6.2 38..........................................................................................................................
Updating the base station5.6.3 38.....................................................................................................................
Updating the iPad5.6.4 38...............................................................................................................................
Installing the user interface certificate5.6.5 39....................................................................................................
Troubleshooting5.7 39..................................................................................................................................
User interface error messages5.7.1 39..............................................................................................................
“No connection to sensor” error message5.7.1.1 39..............................................................................................
“Low sensor battery level” error message5.7.1.2 40...............................................................................................
“New firmware for sensor” error message5.7.1.3 40..............................................................................................
Fault table5.7.2 41..........................................................................................................................................
Measures5.7.3 43...........................................................................................................................................
Check connections to LAN and WLAN5.7.3.1 43..................................................................................................
Resetting frozen user interface (timeout)5.7.3.2 43................................................................................................
Replacing faulty product components5.7.4 44....................................................................................................
Switching off5.8 44......................................................................................................................................
Cleaning6 45.............................................................................................................................................................
Disposal7 45.............................................................................................................................................................
Legal information8 46..............................................................................................................................................
Liability8.1 46..............................................................................................................................................
CE conformity8.2 46.....................................................................................................................................
Trademarks8.3 46........................................................................................................................................
Local Legal Information8.4 46.......................................................................................................................
Symbols Used9 48....................................................................................................................................................
Technical data10 49...................................................................................................................................................
4 743A250 Bionic Pro
Table of contents

1 Notes regarding the document
INFORMATION
Last update: 2019-11-22
►Please read this document carefully before using the product.
►Follow the safety instructions to avoid injuries and damage to the product.
►Please contact the manufacturer if you have questions about the product (e.g.regarding the start-up, use,
maintenance, unexpected operating behaviour or circumstances). Please see the back for contact informa
tion.
►Please keep this document in a safe place.
This document and the product are intended exclusively for qualified personnel with technical knowledge regarding
orthopaedic fitting for patients.
743A250 Bionic ProInstructions for use..............................................................................................3743A250 Bionic Pro (For clinical study)Gebrauchsanweisung...........................................................................................3 Bionic ProDEQuick reference guideKurzanleitungEN
100 %1234567.bionicpro.local743A250 Bionic ProInstructions for use..............................................................................................3743A250 Bionic Pro (For clinical study)Gebrauchsanweisung...........................................................................................3
User GuideInhaltsverzeichnis1. Die Anwendung1.1 Das Schnellmenü100 %1234567.bionicpro.localStartseite Bionic ProEinrichtung und HilfeFallfuß VersorgungWillkommen! Starten Sie Ihre Anwendung:Outcome MeasurementBenutzername eingebenBenutzername eingeben
1
The product includes the following documents, which are important for the use of the product:
:Instructions for use (printed, in black and white)
The document is enclosed in the case with the product (German, English).
:Instructions for use (digital, in colour)
The document can be retrieved via the user interface of the product on the tablet. This document is updated during
the automatic updates of the base station if a new version is available.
:Quick reference guide (printed, in colour)
The document is enclosed in the case with the product (German, English).
:Online help (digital, in colour)
The document can be retrieved via the user interface of the product on the tablet. This document is updated during
the automatic updates of the base station if a new version is available.
1.1 Meanings of pictograms in the illustration

1
Numbering for a defined sequence 
1
Numbering for the parts of an illustration

J
Right  Wrong
1.2 Illustration of the tablet and the user interface of the operating system
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).
5743A250 Bionic Pro
Notes regarding the document

1.3 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
1.4 General safety instructions
CAUTION
Damaged electronic components
Electric shock due to contact with live components
►Check the product for damage (e.g.cable, housing) prior to each use while in a de-energised state.
CAUTION
Mechanical damage to the product
Risk of injury, change in or loss of functionality
►Use caution when working with the product.
►If the product is damaged, check it for proper function and readiness for use.
►In case of changes in or loss of functionality, do not continue using the product.
►Take any necessary measures (e.g.repair, replacement, inspection by the manufacturer’s customer service,
etc.).
NOTICE
Contact with heat, embers or fire
Damage to the product due to high temperatures
►Keep the product away from open flames, embers and other sources of heat.
NOTICE
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 (section "Technical data"- see Page49).
NOTICE
Use under unallowable environmental conditions
Damage to product due to unallowable environmental conditions
►Do not expose the product to unallowable environmental conditions.
►If the product has been exposed to unallowable environmental conditions, check it for damage.
►If damage is apparent or in case of doubt, do not continue using the product.
►Take suitable measures if required (e.g. cleaning, repair, replacement, inspection by the manufacturer or a
specialist workshop, etc.).
NOTICE
Penetration of dirt and moisture
Product damage, loss of functionality and malfunction due to penetrating substances
►Make sure that solid particles (e.g.dust), moisture (e.g.water vapour) and liquids cannot penetrate into the
product during transport, storage and use.
►Refer to the specifications regarding the ambient conditions in the “Technical data” (see Page49) section
under the “Ambient conditions” heading.
6
Notes regarding the document
743A250 Bionic Pro

2 Product description
743A250 Bionic Pro product overview
2
The Bionic Pro consists of the following main components:
:Base station with mains plugs :iPad with mains plugs
:Sensors :Pelvic belt with two extensions
:Thigh belt with one extension :Calf belt with one extension
:Two foot clips :Router with mains plugs
:Case
General functionality
:The sensor holders and extension straps are used to position the sensors on the patient. The sensors record
the patient’s movements and send the measured data to the base station via the router. The base station evaluates
the measured data from all the sensors and visualises the results on the graphical user interface, which is dis
played in the iPad browser.
Functionality of the 743A250 Bionic Pro
The 743A250 Bionic Pro is intended for movement analyses when testing and comparing different orthoses. The
results of the measurements make it possible to provide objective evidence regarding which orthosis is most suit
able for the patient.
:To carry out the measurement, the 743A250 Bionic Pro requires five sensors (one in the pelvic region, one
each in the heel region on both feet and one each on the lateral side of the thigh and lower leg of the leg to be fit
ted).
:First, the patient walks along a straight course for 10m without an orthosis. Then the measurement is repeated
with the orthoses that are to be compared with one another. The base station evaluates the results of the measure
ments and displays the result in the graphical user interface in the browser of the iPad. The patient’s gait can
optionally be recorded with the iPad camera during measurement.
7743A250 Bionic Pro
Product description

3 Scope of delivery
3.1 Removing the product components from the case
743A250 Bionic ProInstructions for use..............................................................................................3743A250 Bionic Pro (For clinical study)Gebrauchsanweisung...........................................................................................3Bionic ProDEQuick reference guideKurzanleitungENBionic Pro https://1234567.bionicpro.localPIN: 1234PW: 12345678901234SSID: 1234567.bionicpro
3
►Always use the product case for transportation.
The illustration shows where the product components are placed in the upper and lower sections of the case.
►NOTICE!To avoid damage during transportation, do not expose the product to severe vibrations, extreme tem
peratures and high relative humidity.
►Lift and transport the case by the handle.
►Use the supplied packaging material or an equivalent for shipping.
►Remove the product components from the case to check the scope of delivery.
8
Scope of delivery
743A250 Bionic Pro

3.2 Checking the scope of delivery
743A250 Bionic Pro (For clinical study)Gebrauchsanweisung...........................................................................................3743A250 Bionic ProInstructions for use..............................................................................................3
Bionic ProDEQuick reference guideKurzanleitungENBionic Pro https://1234567.bionicpro.localPIN: 1234PW: 12345678901234SSID: 1234567.bionicpro
4
:1x642V80
Case
:2x743Y829
Flex loop strap extension for hip
:1x743Y792
Hip bracket
:1x743Y791
Thigh bracket
:1x743Y830
Flex loop strap extension for thigh
:1x743Y831
Flex loop strap extension for lower leg
:1x743Y790
Lower leg bracket
:2x743Y789
Foot bracket
:1x743Y793=P
Bionic Pro pelvis sensor
:1x743Y793=T
Bionic Pro thigh sensor
:1x743Y793=C
Bionic Pro calf sensor
:1x743Y793=FR
Bionic Pro foot right sensor
:1x743Y793=FL
Bionic Pro foot left sensor
:1x757S8=US
Two-pole small device cable (type A plug)
:743Y787=V1
Base station (with power supply)
:1x757S8=EU
Two-pole small device cable (type C plug)
:1x743Y826=V1
Apple iPad
:1x757S9=US
US primary adapter (duck head) for Apple N
:1x743Y827=V1
Ubiquiti Amplifi Instant Router (AFi-INS)
:1x757L42=V1
US universal power supply for 743Y827=V1
:1x743Y832=V1
Plastic card with access data for Bionic Pro
:1x646D1448=ALL_INT
Bionic Pro “Kurzanleitung/Quick reference guide”
:1x
Supplier documentation (iPad, Ubiquiti Amplifi Instant Router)
:1x647G1361=DE_INT
Instructions for use (German)
:1x647G1361=EN_INT
Instructions for use (English)
9743A250 Bionic Pro
Scope of delivery

4 Preparing product for use
►NOTICE!To avoid loss of functionality and damage to the product, only use components, spare parts and soft
ware approved by the manufacturer.
Requirements for the installation location
5
►Observe the following aspects when selecting the installation location:
→A space in which the patient can walk along a straight course for approx.10m at a natural walking speed is
required for the measurement. There should not be any turns or curves along this straight course, as this
would change the patient’s gait and distort the measurement.
→If there is no LAN connection at the installation location for the measurement, a second installation location
is required where a connection to the Internet can be established so the daily update check can be per
formed.
General information on preparing the product for use
The following sections contain the steps required to prepare the product for use. Some of the steps are also neces
sary in day-to-day use.
The product is switched on as described in the following sections: “Connecting the router to the power supply”
(see Page12), “Connecting the base station to the power supply” (see Page14), “Charging switched off sensors
in the base station and switching them on prior to measuring” (see Page15) and “Switching on the tablet” (see
Page16).
The “Connecting the tablet to the power supply” (see Page11) section is important when preparing the product for
use for the first time and when recharging the tablet.
The “Connecting the router to the Internet” (see Page13) section is required when preparing the product for use
for the first time and for the daily update check.
The “Setting up the tablet” (Setting up the iPad) 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.
10
Preparing product for use
743A250 Bionic Pro

4.1 Connecting the iPad to the power supply
6
The iPad charges when it is connected to the power supply. Completely discharging the iPad reduces its service
life. Recharging is recommended when the battery level is between 20 and80%. A level of 100%does not need to
be reached when charging.
►Use the plug (typeC) for outlets of typesF, E, K, L and J.
►Use the plug (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.
11743A250 Bionic Pro
Preparing product for use

4.2 Connecting the router to the power supply
7
►NOTICE!To maintain functionality, only use the router that came with the product and do not make any modific
ations to the router settings.
The router is switched on when it is connected to the power supply. The router then sets up the WLAN network
that was configured at the factory (time: approx.10min).
►Use the plug (typeC) for outlets of typesF, E, K, L and J.
►Use the plug (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 mains plug of the router to the power supply.
→The WLAN is ready for the iPad, the base station and the sensors after a few minutes (approx.10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.
12
Preparing product for use
743A250 Bionic Pro

4.3 Connecting the router to the Internet
8
The router represents the Internet connection on the customer side (router or Internet-ready LAN socket). The
router does not need to be connected to the Internet throughout the day. You can keep all product components up
to date by connecting to the 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.
9
The display on the router’s screen changes from “Plug in cable” to the time and date when the LAN cable is
plugged in.
►Check the customer’s Internet connection if the “No Internet access” screen is displayed.
13743A250 Bionic Pro
Preparing product for use

4.4 Connecting the base station to the power supply
10
The base station is switched on when it is connected to the power supply.
►Use the plug (typeC) for outlets of typesF, E, K, L and J.
►Use the plug (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 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.
14
Preparing product for use
743A250 Bionic Pro

4.5 Charging switched off sensors in the base station and switching them on prior to
measuring
11
►:Check whether all the LEDs on the base station are illuminated ( :Power LED; :WLAN LED; :Sys
tem status LED).
►:NOTICE!Only charge switched-off sensors in the base station. Refer to the ambient temperature for char
ging in the “Technical data” (see Page49) section under the “Ambient conditions” heading.
INFORMATION:The charging time for the sensors is approx. 4hours.
:Switch on the sensors with a fine-tip pen or a similar pointed tool or object prior to measuring.
Meaning of the base station LED signals
LED signal :Power LED :WLAN LED :System status LED
Not illuminated No power supply connected
Illuminated Power supply connected WLAN connection to router
established
Boot process completed,
base station ready
Flashing slowly WLAN connection to router
interrupted, base station set
ting up own WLAN network
Flashing quickly WLAN connection to router
being established
Base station booting
Meaning of the sensor LED signals
LED signal Meaning
Not illuminated Sensor switched off or completely discharged
Illuminated (white) No WLAN connection
Modulating (blue) Charging and connected to base station via WLAN
Flashing (yellow) Update being installed – do not switch off and do not remove
from base station!
15743A250 Bionic Pro
Preparing product for use

4.6 Switching on the iPad
12
4.7 Setting up the iPad
HelloDEEN
13
The iPad needs to be set up when preparing the product for use for the first time (e.g.select the system language,
set up Apple ID, configure basic settings). The iPad needs to be connected to the supplied router via WLAN for
this purpose. The router must be connected to the Internet. The iPad was configured to automatically connect to
the WLAN of the router at the factory (do not connect to different WLAN!).
More detailed information on setting up the iPad can be found on the following websites, which can also be
accessed via the respective QR codes:
:DE (German) – https://support.apple.com/de-de/guide/ipad/ipad995bb83d/ios
:EN (English) – https://support.apple.com/guide/ipad/turn-on-and-set-up-ipad995bb83d/ios
►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.
16
Preparing product for use
743A250 Bionic Pro

5 Use
INFORMATION
The QR codes, nameplates and passwords contained in the illustrations are only samples and may not be used.
Only the QR codes in the iPad user manual are intended for use (may be changed by Apple).
5.1 Switching on
~ 10 min~ 5 min
14
►Follow the sequence shown in the illustrations when switching on the product and adhere to the waiting times
so the product components connect with one another properly via WLAN.
5.2 Preventing electromagnetic interference
The individual product components (base station, sensors, router) are connected with each other via WLAN and
enable the required exchange of data. Other devices that produce electromagnetic fields or networks can cause
electromagnetic interference that slows the exchange of data or makes it impossible. This may mean that a meas
urement needs to be repeated. Electromagnetic interference may be indicated by error messages on the user inter
face or manifest itself by the user interface working more slowly. The following instructions help to prevent or elim
inate electromagnetic interference.
►Do not use the product in areas with strong electromagnetic fields (e.g.in the proximity of magnetic resonance
imaging equipment).
►During use of the product, ensure that other high-frequency devices, suchas mobile phones, smartphones,
tablets and routers do not come within the required safety distance of at least 300mm to the product compon
ents (base station, sensors, router).
►Refer to the instructions in the “Troubleshooting” (see Page39) section and its subsections in the event of
faults or error messages.
→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.
17743A250 Bionic Pro
Use

5.3 General information on the use of the iPad
DEENUser GuideBenutzerhandbuchiPad
15
More detailed information on the use of the iPad can be found on the following websites, which can also be
accessed via the respective QR codes:
:DE (German) – https://support.apple.com/de-de/guide/ipad/welcome/ios
:EN (English) – https://support.apple.com/guide/ipad/welcome/ios
►Refer to the “Scanning the QR code” (see Page21) section to use the QR code.
5.3.1 Home screen and dock
100 %EinstellungenKameraBionic ProRouter UpdateApp Store100 %
16
Apps and links are displayed on the home screen and can be started by tapping them. The home
button will always take you back to the home screen. 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.
18
Use
743A250 Bionic Pro

5.3.2 Important apps
17
The following apps are important for use:
:Safari – browser which is used to display the user interface of the product and start updates for the router
:Settings – app for managing all settings (e.g.WLAN, updates, Apple ID)
:Mail – e-mail program
:Files – file manager
:App Store – app for installing apps
:Camera – for taking photos and videos and scanning QR codes
:Photos – for viewing photos, videos and screenshots
5.3.3 Important links
18
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.
19743A250 Bionic Pro
Use

5.3.4 Taking screenshots
100 %
100 %
100 %100 %
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19
A screenshot is required in some cases (e.g.for the service team when describing an error). Take a screenshot as
follows:
►:Press the home button and on/off switch at the same time.
►:The screenshot is briefly displayed in the bottom left corner and can be tapped to display it.
►:The screenshot can subsequently be displayed with the “Photos” app.
5.3.5 Using the app toggle
2x
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20
The app toggle is the function that is used to display all open apps. This function can be used to switch between
the apps or switch apps off.
►:Double-click the home button.
►: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.
20
Use
743A250 Bionic Pro