Bauerfeind Uniprox OR05 User manual

OR05 Becker Spinal Orthosis
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www.uniprox.de
Rev.0 2021 08_OR05
Qualität und Funktion
Gebrauchsanweisung
Instruction Manual
Distributed by:
Uniprox GmbH & Co.KG, H. Heine Str.4, 07937 Zeulenroda Triebes
Becker Orthopedic
635 Executive Drive
Troy, MI 48083 United States
Acorn Regulatory
Knockmorris Cahir
Co. Tipperary
Ireland, E21 R766

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Please read the I U carefully before fitting. Only correct usage will
warrant the function.
1. Intended Use
Sagittal postural realignment and pain reduction
2. Technische Daten
3. Indication/ Contraindicationen
Indicationen:
•Conservative treatment of vertebral compression fractures with stable posterior
wall
•Lumbar adolescent kyphosis with compensating thoracic hyperextension
•After vertebral fractures
•Postoperatively
•Osteoporosis
Contraindicationen
•None
4. Side effects
•Improperly fitted brace may cause cardiorespiratory discomfort
Order No. Back-Pad xxx Article No.
OR05 S „Extra wide“ S 4 506 020 02 00 000
OR05 M „Extra wide“ M 4 506 020 01 00 000
OR05 L „Extra wide“ L 4 506 020 03 00 000
5. General Instructions
•This medical products is single patient multiple use.
•Fitting/service of the medical devise is only allowed by a certificated orthopedic
professional.
•The professional should instruct the correct use of the devise to the user.
5.1 Information for orthopedic professional
When you deliver the completed orthosis, please discuss basic maintenance
procedures with your patient and give him/her this IFU.
Please write in product model and lot number information below. This section should
be signed by the patient as proof he/she has been given maintenance instructions.
Make a copy of this page and then attach it to your patient file.
5.2 Information for patient
•When not in use, your orthosis should be stored away from open flame or direct
sunlight. Metal parts can conduct heat and plastic can deform or deteriorate
prematurely due to heat effects.
•As a daily donning routine, you should perform the following safety check:
oInspect for dents, scratches or cracks.
oStraps should be secure and have no tears.
oMake sure all rivets and screws are tight.
•If you have any problems, notice any undue wear, or observe any unsafe or unusual
condition in the orthosis, contact your orthotist immediately.
Orthotist:
Phone:
Model #: LOT #:
Date:
Patient Signature:
(Please attach to patient file)

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6. Cleaning
To clean, wipe with a damp cloth with mild detergent.
7. CE-Conformity
The product satisfies the requirements of Regulation (EU) 2017/745 of the European
Parliament and of the Council (MDR) and bears the CE mark. All major incidents related
to the product needs to be informed to Uniprox and/ or Becker Orthopedics as well as to
the competence European Authority.
8. Warranty an Guarantee
•One year limited warranty for defects in workmanship
9. Disposal
Dispose of in accordance with local laws and regulations for aluminum and leather.
Please direct any questions to:
Customer Service: + 49 (0) 36628 66 33 70
Fax: + 49 (0) 36628 66 33 77
E mail: [email protected]