Orthofix M6-C Artificial Cervical Disc Gebrauchsanweisung Seite 7

These conditions do not include all potential adverse effects that may occur, but are important considerations in relation to the
use of the M6‑C Artificial Cervical Disc.
MrI s I
afety nforMatIon
Non‑clinical testing has demonstrated that the M6‑C Artificial Cervical Disc is MR Conditional. A patient with the
M6‑C Artificial Cervical Disc can be scanned safely in an MR system under the following conditions:
•
Static magnetic field of 1.5‑T or 3.0‑T, only
•
Maximum spatial gradient magnetic field of 4,000‑Gauss/cm (40‑T/m)
•
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2‑W/kg for 15 minutes of scanning (i.e.,
per pulse sequence) in the Normal Operating Mode.
Under the scan conditions defined, the M6‑C Artificial Cervical Disc is expected to produce a maximum temperature rise of 2.2°C
after 15‑minutes of continuous scanning (i.e., per pulse sequence).
In non‑clinical testing, the image artifact caused by the M6‑C Artificial Cervical Disc extends approximately 10‑mm from this
device when imaged using a gradient echo pulse sequence and a 3.0‑Tesla MR system.
H s
oW UpplIed
•
The M6‑C Artificial Cervical Disc is supplied sterile and is single use only. Do not re‑sterilize or reuse the M6‑C Artificial Cervical
Disc. Re‑sterilizing and/or reusing the M6‑C Artificial Cervical Disc may result in impaired performance and could cause patient
injury and/or the communication of infectious diseases between patients.
•
Do not use the M6‑C Artificial Cervical Disc after the last day of the month of the "Use by date" on the label.
•
Inspect the device package before opening. Do not use if package is damaged or shows any evidence of breached packaging,
compromised device sterility, or storage above 60°C (140°F). The temperature recorder label on the box turns black if the
product has reached 60°C (140°F).
•
Use sterile technique to carefully remove the Disc from the packaging. Inspect the M6‑C Artificial Cervical Disc to ensure it
exhibits no signs of damage (e.g., metal and plastic damage).
•
Once removed from the package, keep the M6‑C Artificial Cervical Disc from coming into contact with any cloth, sponges or
other foreign material that may become attached to the Titanium Plasma Spray Coating of the endplates.
•
The M6‑C Artificial Cervical Disc serial number and the size must be documented for each patient record.
d r
evIce etrIeval
Please contact Spinal Kinetics to receive specific instructions regarding the preferred method for explant handling and transport
as well as data collection, including histopathological, mechanical, patient, and adverse event information. Please refer to M6‑C
Artificial Cervical Disc Operative Technique Manual for step‑by‑step instructions on the required surgical technique for device
removal. All explanted devices must be returned to Spinal Kinetics for analysis.
It is preferred that no cleaning, decontamination or sterilization be performed at the hospital. Some surgical centers may
require that the device be decontaminated or sterilized prior to leaving the facility. Note that many sterilization methods will
damage the device (e.g., autoclaving, immersion in alcohol), and the effects of other methods are unknown. Rinsing with water
or saline is acceptable. If decontamination and sterilization are required, 10% neutral buffered formalin is best. If cleaning,
decontamination or sterilization is performed, note what cleaning methods and materials were used.
It is preferred that the explanted device is packed "dry" (no fluid) or wrapped in formalin‑soaked gauze. The device can be gently
rinsed with water or saline to remove excess blood and fluids.
Send explant in a leak‑proof container, with the date of removal, explanting surgeon, and any known information regarding
initial implantation, reasons for removal, and adverse event information. Please note that the explanted M6‑C Artificial Cervical
Disc should be removed as carefully as possible in order to keep the implant and surrounding tissue intact if possible. Also, please
provide descriptive information about the gross appearance of the device in situ, as well as descriptions of the removal methods,
i.e., intact or in pieces. Spinal Kinetics will request additional information regarding the reason for removal, patient information
and associated clinical outcomes.
NOTE: All implant removals must be reported immediately to Spinal Kinetics.
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