General Information And Warnings; Product Identification - PFM Medical Nit-Occlud Le VSD Mode D'emploi

General Information and Warnings

Before initial use of this product, all users should receive instructions on how to use it so that they can gain the necessary
practical experience. To arrange an appointment, please contact pfm medical ag or your authorised dealer. The product
described here may be used only by specialist physicians who are familiar with the techniques used in diagnostic and
interventional cardiology.
These instructions for use and the information on the packaging should be read carefully before each use.
WA R N I N G S
Do not use the product if the packaging has been opened, or is damaged, if you are not sure that it is
sterile, or if the expiry date has passed.
Each product is packed separately, and is delivered in an EO-sterilised and pyrogen-free condition. It is intended for single
use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization of single-use devices may result in
degraded performance or a loss of functionality. Reuse of single-use devices may result in exposure to pathogens such
as viruses, bacteria, fungi, or prions. The product must be stored in dry conditions. Do not expose the packaged products
to direct sunlight.

Product Identification

Each product label has peel-off labels, to allow the product to be identified precisely. These can be used for the patient file
and the patient ID card.
MR-Compatibility
Non-clinical testing (gemäß ASTM F2503) has demonstrated the Nit-Occlud® Lê VSD device (implant only!)
to be MR conditional. It can be scanned safely, immediately after placement of the implant, under the
following conditions:
• Static magnetic field of 3 Tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Normal operating mode of the MR system and use of whole body transmit coil for 15 min. of scanning or less
Note:
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position
of the Nit-Occlud®Lê VSD Spiral Coil. Therefore, optimization of MR imaging parameters to compensate for the presence
of this device may be necessary.
Specific description of test results:
Dislocation Force/Torque:
Non-clinical testing was performed fulfilling the requirements of ASTM F2052-06e1 and ASTM F2213-06 in a static mag-
netic field of 3.0Tesla. The Nit-Occlud® Lê VSD device showed only minimal interaction with the magnetic field with the
dislocation force being significantly below the gravitational force (i.e. the weight) of the implant.
Heating:
Non-clinical testing of RF-induced heating was performed according to ASTM F2182-02a at 128MHz in a GE Excite HDx
3.0T system (General Electric Healthcare, Milwaukee, WI), software version 14X.M5 using the body RF receive/transmit
coil. The patient phantom was prepared to simulate the electrical and thermal properties of human tissue (50kg head/
torso phantom according to ASTM F2182-02a) and the device was in a location in the phantom that is known to produce
worst case heating. RF power was applied for 15 minutes resulting in a phantom average SAR (calorimetry) of 2.7W/kg
(software reported 2.9 W/kg) and spatial peak SAR (calorimetry) of 5.4 W/kg (software reported 6.0 W/kg).
The maximum temperature rise was 1.2°C when the WB-SAR was scaled to 2 W/kg. The actual in-vivo rise is expected to
be less as this testing did not include the cooling effects due to blood flow and blood perfusion of tissue.
GA053/Rev02_2019-04-18
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