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8 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

8.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­
tions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the
information in this document, particularly due to improper use or unauthorised modification of the product.

8.2 CE conformity

With the exception of the iPad and the router, the following directive applies to all other product components of the
743A250 Bionic Pro:
This product meets the requirements of the European Directive 93/42/EEC for medical devices. This product has
been classified as class I accessories according to the classification criteria outlined in Annex IX of the directive.
The  declaration  of  conformity  was  therefore  created  by  the  manufacturer  with  sole  responsibility  according  to
Annex VII of the directive.
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
ardous substances in electrical and electronic devices.
This device meets the requirements of the European Directive 2014/30/EU. The declaration of conformity was cre­
ated by the manufacturer according to Annex II of the Directive.
This product meets the requirements of the European Directive 2014/53/EU for radio equipment and telecommu­
nications terminal equipment.

8.3 Trademarks

All  product  names  mentioned  in  this  document  are  subject  without  restriction  to  the  respective  applicable  trade­
mark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of the respective
owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justify the conclusion
that the denotation in question is free of third-party rights.

8.4 Local Legal Information

Legal information that applies 

exclusively

 to specific countries is written in the official language of the respective

country of use in this chapter.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) This device may not cause harmful interference, and
2) This device must accept any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harm­
ful interference to radio or television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.

Caution: Exposure to Radio Frequency Radiation.

This device must not be co-located or operating in conjunction with any other antenna or transmitter.
Responsible party:

46

Legal information

743A250 Bionic Pro

Содержание 743A250

Страница 1: ...743A250 Bionic Pro Instructions for use 3...

Страница 2: ...2 743A250 Bionic Pro...

Страница 3: ...k 5 3 1 18 Important apps 5 3 2 19 Important links 5 3 3 19 Taking screenshots 5 3 4 20 Using the app toggle 5 3 5 20 Scanning QR codes 5 3 6 21 Scanning the WLAN QR code 5 3 6 1 21 Scanning the websi...

Страница 4: ...tificate 5 6 5 39 Troubleshooting 5 7 39 User interface error messages 5 7 1 39 No connection to sensor error message 5 7 1 1 39 Low sensor battery level error message 5 7 1 2 40 New firmware for sens...

Страница 5: ...eben Benutzername 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...

Страница 6: ...roduct 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...

Страница 7: ...50 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 rega...

Страница 8: ...6 7 bi oni cpr o 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 duri...

Страница 9: ...r 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...

Страница 10: ...ng 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 Connecti...

Страница 11: ...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 typ...

Страница 12: ...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 p...

Страница 13: ...ach 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 Bio...

Страница 14: ...r 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 t...

Страница 15: ...ase 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...

Страница 16: ...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...

Страница 17: ...nt 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 h...

Страница 18: ...the Scanning the QR code see Page 21 section to use the QR code 5 3 1 Home screen and dock 100 Einstellungen Kamera Bionic Pro Router Update App Store 100 16 Apps and links are displayed on the home s...

Страница 19: ...r 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 importan...

Страница 20: ...ed to display it The screenshot can subsequently be displayed with the Photos app 5 3 5 Using the app toggle 2x 1 0 0 100 20 The app toggle is the function that is used to display all open apps This f...

Страница 21: ...Position the camera so the WLAN QR code is in the viewfinder Tap the WLAN QR code connect with 1234567 bionicpro network button to establish the WLAN con nection 5 3 6 2 Scanning the website QR code...

Страница 22: ...re points due to tight application to the body Ensure that the product is applied properly and fits correctly When in doubt do not continue to use the product if skin irritation occurs CAUTION Reuse o...

Страница 23: ...r the shoelaces FR foot right Positioning foot clip centred on the hindfoot right over the sole of the shoe plastic tongue under the shoelaces CAUTION To protect the skin position the sensor holders o...

Страница 24: ...rations and texts may be shifted so content is not displayed in an ideal manner or is even incorrect 5 5 2 Accessing the user interface for the first time Bionic Pro Anmelden Willkommen Bitte melden S...

Страница 25: ...is opened in a new tab In this case you should tap the old tab and use the icon to close the old tab 5 5 4 Homepage Startseite Bionic Pro Einrichtung und Hilfe Fallfu Versorgung Willkommen Starten Sie...

Страница 26: ...he help is kept up to date when the base station is updated 5 5 6 Settings Kontakt und Service Datenschutz hinweis System Informationen Gebrauchs anweisung Einstellungen anpassen Impressum Einstellung...

Страница 27: ...019 6 24 dev0 git44698e5f Basis Station Zur cksetzen Achtung Alle Daten inkl der Patienten und Messdaten werden gel scht Serial Freier Speicher f 9 9 GB Lokale IP Addresse 172 28 1 1 Datum Zeit Wed Ju...

Страница 28: ...rthosis 5 5 6 4 Imprint Ottobock SE Co KGaA Max N der Str 15 37115 Duderstadt Deutschland Management Vorsitzender des Verwaltungsrats Professor Hans Georg N der Telefon und Telefax Telefon 49 5527 848...

Страница 29: ...C Nachname Vorname Sortieren nach Bitte Suchbegri eingeben Neuer Kunde Kunden bersicht 100 1234567 bionicpro local Benutzername eingeben 38 Tapping the Customer overview button displays the customer o...

Страница 30: ...C Nachname Vorname C Nachname Vorname C Nachname Vorname C Nachname Vorname C Nachname Vorname Sortieren nach Bitte Suchbegri eingeben Kunden bersicht 100 1234567 bionicpro local Benutzername eingeben...

Страница 31: ...eingeben Assessment starten 44 Note the text displayed on the Assessment preparation page and then tap the Next button The Sensor setup page subsequently opens Sensor setup when measuring without an o...

Страница 32: ...ekunden in neutraler Standposition bleiben und dann 10 m geradeaus gehen 1 F r eine korrekte Messung bitte ca 3 Sekunden in neutraler Standposition bleiben und dann 10 m geradeaus gehen 2 F r eine kor...

Страница 33: ...nsor setup when measuring with an orthosis Sensoreinrichtung Weiter Messung starten Messung starten 1 2 3 4 Fixieren Sie an der betro enen Seite Fixieren Sie an der Beckenposition den langen Gurt und...

Страница 34: ...o to result if the progress was satisfactory and the result should be displayed on the Drop foot fit ting assessment page Zum Ergebnis Neue Messung Fallfu Versorgungs Assessment Das Gangbild wurde erf...

Страница 35: ...hosis for customer Orthese f r Kunden speichern OK gespeichert werden den Kundeninformationen Welche Orthese soll in L100 Go Orthese wurde f r Kunde gespeichert 54 Use the Save orthosis for customer b...

Страница 36: ...t or transferred to another computer with a USB cable in conjunction with the iTunes program for this purpose Further details regarding this can be found in the iPad user manual link in the General in...

Страница 37: ...orgungs Assessment XXXXX mp4 58 Tap the camera icon until the small window with the video and context menu appears Tap the Load linked file icon in the context menu to download the file to the browser...

Страница 38: ...ion 1234 59 Tap the Update router link to open the user interface of the router in a new tab in the Safari browser Enter the WLAN password PW as the LOGIN Start an available update by tapping the BEGI...

Страница 39: ...ayed in a warning window The error message can be temporarily ignored by tapping the Back browser button or selecting Update later In this case the red warning icon reminds you of the ignored error me...

Страница 40: ...eine neue Firmware der Sensoren vor Stecken Sie die Sensoren zum Updaten in die Basisstation und schalten das System w hrend des Update Vorgangs nicht aus Jetzt aktualisieren Sp ter aktualisieren 100...

Страница 41: ...ified by LEDs on base station not lit Connect base station to mains network Base station in configuration mode button on back accident ally pressed Identified by Centre LED WLAN on base station flashi...

Страница 42: ...fied by Sensor not charged despite pre vious steps User interface working at slower pace Interference due to other HF devices Refer to the instructions in the Preventing electromagnetic interference s...

Страница 43: ...these criteria are satisfied and there are still problems with the WLAN connection follow the instructions in the Preventing electromagnetic interference section see Page 17 5 7 3 2 Resetting frozen u...

Страница 44: ...he 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...

Страница 45: ...ve the sensors prior to washing Wash the sensor holders and extension straps on a regular basis hand wash with mild detergent do not iron do not bleach do not tumble dry do not dry clean Disinfecting...

Страница 46: ...e registered trademarks and are the property of the respective owners Should trademarks used in this document fail to be explicitly identified as such this does not justify the conclusion that the den...

Страница 47: ...terference radio lectrique re u m me si celle ci est susceptible de compromettre le fonctionnement du dispositif Caution Exposure to Radio Frequency Radiation The installer of this radio equipment mus...

Страница 48: ...household waste Disposal that is not in accordance with the regulations of your country may have a detri mental impact on health and the environment Please observe the instructions of your national au...

Страница 49: ...emissions are very low and interference with neighbouring elec tronic devices is unlikely HF emissions according to CIS PR11 Class B Emission of harmonics according to IEC 61000 3 2 Class A Emission o...

Страница 50: ...ct must ensure that it is operated in such an environment INTERFERENCE IMMUNITY TESTS IEC 60601 test level Compliance level ELECTROMAGNETIC ENVIRONMENT direct ives Conducted HF interfer ence according...

Страница 51: ...ng the minimum distance which depends on the output of the telecommunication device as specified below between portable and mobile HF telecommunication equipment transmitters and the product Nominal o...

Страница 52: ...tput W Distance m Interference immunity lim it values V m 1 970 1 700 1 990 GSM 1900 DECT LTE band 1 3 4 25 UMTS 217 Hz 2 0 3 28 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Puls...

Страница 53: ...53 743A250 Bionic Pro...

Страница 54: ...54 743A250 Bionic Pro...

Страница 55: ...55 743A250 Bionic Pro...

Страница 56: ...ersion SB_2016 10 21 FM483 SB_210x297 Ottobock SE Co KGaA Max N der Stra e 15 37115 Duderstadt Germany T 49 5527 848 0 F 49 5527 848 3360 healthcare ottobock de www ottobock com Ottobock 647G1361 en_I...

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