Access of eIFU

Manufacturers shall provide information on how to access the instructions for use in electronic form. This information is provided on the product label, packaging for each unit and on the sales packaging.

Manufacturer providing information on the web page and same information listed in eIFU about where, how and within which time instructions for use in paper form can be requested at no cost.

eIFU for ROOTT medical devices does not contain a part of the instructions for use which is intended to be provided to the patient, its for use by professional users only.

eIFU for ROOTT medical devices in electronic form are available entirely as text which contain symbols and graphics with the same information as the instructions for use in paper form. Video files may be offered in addition to the text of the eIFU and mentioned in eIFU as references.

Paper version request information

By the request, provided via email, phone call or post mail, the printed version of the instruction for use will be sent as requested at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order.

Email: vladlena.shulezhko@trate.com

Phone: +41798481918

Instructions for use

Click on the links below to view the IFU (Instructions for Use) Documents:

* Please note that translations are automatically generated for your convenience and may not be accurate. For accurate information refer to the original files.

This warranty and return policy applies to all products, produced by TRATE AG. This policy only covers the replacement of products, but not any associated costs and expenses, including but not limited to any associated treatments.

Warranty conditions

TRATE AG hereby guarantees that, if any product is defective as a result of a failure of the material strength and stability of the product during the guarantee period, TRATE will replace the product with the same or substantially equivalent product.

Provided however that the following guarantee conditions are individually and collectively met and documented:

  • Warranty duration – lifetime, in case, when will be proven that ROOTT system components were used in accordance with the requirements of the instruction for use and under indications, conditions and contraindications which described by the manufacturer in the instructions for use.
  • Products have been used exclusively and not in combination with any other manufacturer’s products
  • Warranty case appeared because products were implanted to the patient with absolute / relative contraindications
  • No guarantee case resulting from an accident, a trauma or any other damage caused by the patient or a third party
  • Providing a request for guaranty not later than three months after a case arises.

Eligibility

To receive warranty benefits, the treating clinician or distributor must:

  1. Notify TRATE AG. Notification is accomplished by submission of a properly completed Warranty and Return Form with return of properly cleaned and decontaminated device packed such to prevent damage throughout transportation. Clear procedure for cleaning, decontamination, packaging and labeling for such devices available in Instruction for Product return.
  2. Be current in all financial account activities with TRATE AG
  3. Be sure that all devices covered by this Warranty Policy installed in accordance with TRATE prescribed procedures, including the IFU, and in accordance with accepted medical / dental practices.

Important! Warranty and Return Form available on the webpage www.trate.com as Annex to the Warranty and Return Policy or you may contact your Customer Service representative. All warranty claim submissions must include the LOT number of all devices. Failure to provide this information or any other required information, or failure to return original devices, may result void of the warranty policy.

Waranty statement for ROOTT implants

Limits and limitations

This warranty policy is the only warranty provided by TRATE AG. TRATE AG hereby disclaims any other warranties, express or implied hereby TRATE excludes any liability for lost earnings and direct or indirect damages as well as collateral and consequential damages, directly and indirectly related to products, services and information.

Guarantee territory

This guarantee applies worldwide to the products manufactured by TRATE AG.

Modification or termination

TRATE may modify or terminate this warranty policy at any time in whole or in part. Changes to or termination of the warranty policy will not affect the warranty given for the products implanted prior to the date of the change or termination.

Product exchange

Not used products can be exchanged (same or greater value) within twelve (12) months of invoice date but must have a minimum six (6) months shelf life.

All items must be in their original packaging, undamaged, unmarked and unopened.

In any case the Warranty and Return Form shall be filled and sent together with the products.

If the product was in use, follow the procedure for cleaning, decontamination, packaging and labeling for such devices available in Instruction for Product return.

Reporting procedure

Distributors / Healthcare professionals / Patients that have received information about suspected incidents related to a TRATE products, shall immediately forward this information to the manufacturer via submission of application in “Contact us” on the webpage www.trate.com or call Customer Service at + 41 79 848 19 18.

ROOTT digital libraries

Animations

Photos 

 

 

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Dane będą przechowywane do czasu realizacji powyższego celu lub do czasu wyrażenia przeze mnie sprzeciwu wobec tego przetwarzania. Administratorem danych osobowych jest Pro-Trate Sp. z o. o. z siedzibą w Warszawie, ul. Bernardyńska 16C lok. U2, wpisaną do Rejestru Przedsiębiorców, prowadzonego przez Sąd Rejonowy dla m.st. Warszawa, Wydział Gospodarczy Krajowego Rejestru Sądowego pod numerem KRS: 0000576171, NIP: 5223038539, REGON: 362514307. Informujemy, że pozyskane dane osobowe mogą być powierzane dla realizacji powyższego celu do innych podmiotów współpracujących z Administratorem Danych. Podane dane będą przetwarzane zgodnie Art. 6 pkt 1 a z Rozporządzenia Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE. Dane gromadzone są na podstawie niniejszej zgody. Dane nie będą poddawane profilowaniu. Podanie danych jest całkowicie dobrowolne, jednakże nie wyrażenie zgody doprowadzi do niemożliwości osiągnięcia celu. Zostałem poinformowany o prawie dostępu do treści swoich danych i ich sprostowania, usunięcia, ograniczenia przetwarzania, prawie do przenoszenia danych, prawie do cofnięcia zgody w dowolnym momencie bez wpływu na zgodność z prawem przetwarzania. Wycofanie na przetwarzanie danych osobowych następuję poprzez wysłanie maila na adres: odo@pro-trate.pl lub wysłanie listu na adres zgodny z adresem rejestrowym. Zostałem poinformowany, o prawie wniesienia skargi do Prezesa Urzędu Ochrony Danych w przypadku stwierdzenia iż przetwarzanie danych osobowych narusza przepisy ogólnego rozporządzenia o ochronie danych osobowych z dnia 27 kwietnia 2016.

z siedzibą w Warszawie, ul. Bernardyńska 16C lok. U2, wpisaną do Rejestru Przedsiębiorców, prowadzonego przez Sąd Rejonowy dla m.st. w Warszawie Wydział Gospodarczy Krajowego Rejestru Sądowego pod numerem KRS: 0000576171, NIP: 5223038539, REGON: 362514307 w celu otrzymywania informacji marketingowych w tym wiadomości typu newsletter oraz informacji handlowych drogą elektroniczną. Podanie danych jest dobrowolne, lecz niezbędne w celu otrzymania newslettera. Oświadczam, że zapoznałam/-em się z klauzulą informacyjną dot. przetwarzania moich danych osobowych.