ulrich medical Obelisc Instructions For Use Manual page 13

PREOPERATIVE WARNINGS
ƒ Only patients that meet the criteria described in the indications section should be considered.
ƒ Patient conditions such as those described in the contraindications should be avoided.
ƒ Handling and storage of implant components is important. Implants should not be scratched, notched or damaged. Alterations will pro-
duce defects in surface finish and internal stresses, which may result in eventual breakage of the implant. The implants should also be
protected during storage particularly from corrosive environments.
ƒ Correct selection of the implant is extremely important. The surgeon should confirm that all of the components are available for surgery and
be familiar with the indications and contraindications of each combination of the various components before using them.
ƒ All parts should be cleaned and sterilized before use. Additional sterile components should be available if needed.
INTRAOPERATIVE WARNINGS
ƒ Extreme caution should be used when working around the spinal cord and nerve roots. Damage to this tissue will cause loss of neurological
functions.
ƒ Breakage, slippage, misuse or mishandling of instruments or implant components may cause injury to the patient and/or operative per-
sonnel.
ƒ Proper selection and insertion of the obelisc is important. An incorrect size obelisc may cause nerve damage, hemorrhage and/or loosening
of the implant.
ƒ To assure maximum stability, wherever possible use one or more supplemental stabilizing spinal implants as described in the operative
technique.
ƒ Prior to wound closure, check to make sure the locking screw is tightened properly according to the surgical technique.
POSTOPERATIVE WARNINGS
ƒ Postoperative care and the patient's ability and willingness to follow instructions are among the most important aspects of successful
outcome. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities. The
patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive
demands are placed on it, especially in the absence of complete bone healing. An active, debilitated or demented patient who can not
properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
ƒ Use of an external brace/orthotic may be necessary for a period of time. The physician will make this determination.
ƒ Patients should be taught to compensate for their inability to bend at the point of spinal surgery.
ƒ Surgical implants should never be reused. An explanted metal implant should never be reimplanted
USE OF ORIGINAL PRODUCTS
ulrich medical implants and instruments are produced and designed to be used together. The use of products from other manufacturers along
with ulrich medical products can involve incalculable risks and/or contamination of the material and misalignments of implant to instrument,
thereby endangering the patient, user or third parties. Only the original instruments of the obelisc implant system may be used for the
handling of the obelisc implant system. Where necessary special instructions are given on the package insert of the respective instrument. At
no time should titanium implants be used together with components made of other materials such as stainless steel or cobalt-chrome (CoCr).
Only original implants shall be used. Use obelisc system components only with other obelisc system components; do not use with components
from any other spinal system or manufacturer.
MATERIAL INFORMATION
The obeliscPRO/obelisc implants are manufactured from a titanium alloy according to ISO 5832-3; ASTM F136. The material is biocompatible,
corrosion-resistant, non-toxic under biological conditions and does not interfere with imaging processes such as X-ray imaging or computer
tomography.
MR conditional
MR
MRI information
ulrich medical obeliscPRO/obelisc implants are classified as «MR conditional" according to ASTM standard F2503.
The «MR conditional» components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a obeliscPRO/
obelisc implant can undergo an MRI examination under the following conditions:
ƒ Field strengths of 1.5 T and 3.0 T
ƒ Highest field gradient of 30 T/m (3000 G/cm) or less
ƒ Maximum specific absorption rate (SAR) of 2 W/kg for normal operating mode for a scan time of 30 minutes
Note: In the experimental test, heating of a maximum of 5.0°C was measured at:
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.
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2019-09-10