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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in buil-
ding a construct.
Components of this system should not be used with components of any other system or manufacturer.
POSSIBLE COMPLICATIONS
In many cases, possible complications are caused by use rather than the implant:
General risks and complications from the operation
Wound healing impairment
Infection
Cardiovascular complications e.g., cardiac arrest, pulmonary heart disease, pulmonary embolism, anemia, thrombosis, embolism, coagu-
lation disorder
Gastrointestinal complications such as: gastritis, stress ulcers, ileus, ulcers
Neurological complications e.g., spinal cord or nerve-root lesions with temporary or permanent sensory and/or motor impairments
Risk in anesthesia, risk in blood transfusions, positioning risks
Intraoperative injury to blood vessels, massive bleeding (hemorrhage)
Insufficient correction and/or absence of bone fusion and necessity for renewal of stabilization
Implant removal or renewal of stabilization due to implant loosening, dislocation, sintering and/or implant failure
Local or systemic reactions due to incompatibility of the materials
Insufficient subjective improvement of the complaint
USE OF GENUINE PRODUCTS
Implants and instruments are developed and manufactured for common use. Unforeseeable risks and/or contamination of the materials may
result from using the products of other manufacturers with those from ulrich medical®, or implants and instruments may not fit together so
that the patient, user or third party may be put at risk. The implants may only be combined with the implants for which they are intended.
Only genuine instruments from the implant system, which are exclusively designed for the purpose, may be used for handling the implants.
Please refer to the special handling instructions on the packaging leaflet of the implant and instrument concerned. Only genuine implants
must be used.
CLEANING, DISINFECTION AND STERILIZATION
Implant
The implants are delivered sterile and do not have to be sterilized again. Examine the packaging carefully before use to check whether the
packaging shows any signs of damage that could affect the sterility of the product. Under no circumstances may implants which have already
been in contact with a patient or have become contaminated be used again; these must be discarded.
Instrument processing instructions
ulrich GmbH & Co. KG
ulrich medical USA
Buchbrunnenweg 12
18221 Edison Avenue
89081 Ulm l Germany
Chesterfield, MO 63005 | USA
Phone +49 (0)731 9654-225
Phone: 636.519.0268, Fax: 636.519.0271
Processing
Basic principles
All instruments, including the sterilization layers and trays, must be thoroughly cleaned, disinfected and sterilized before each use; this applies
especially to the first-time use after delivery because all instruments are shipped in non-sterile condition (clean and disinfect after removing
the transport packaging and sterilize after wrapping). Effective cleaning and disinfection is an indispensible prerequisite for effective steri-
lization. When using instruments, please make sure to keep dirty instruments separate and to not place them back into the instrument tray
in order to prevent serious contamination of the equipped instrument tray. Clean/disinfect the dirty instruments, sort them and place them
back in the instrument tray, then sterilize the entire equipped instrument tray. Within the scope of your responsibility for instrument sterility,
please ensure that only cleaning/disinfection and sterilization processes which have been appropriately validated in a device-specific and
product-specific manner are used, that the employed devices (disinfecting machine, sterilizer) undergo regular maintenance and inspections
and that the validated parameters are complied with during each cycle. In addition, please follow all applicable laws in your country as well as
the hygiene regulations of the medical practice or hospital in question. This applies especially to the various requirements regarding effective
prion inactivation.
Instruments intended for one-time use may not be reprocessed.
2019-07-02
