Disposal Instructions - InspireMD MGUARD Prime Instrucciones De Uso

Stent placement may compromise side branch patency.
•
Do not exceed Rated Burst Pressure (RBP).
•
In case stent size is still inadequate (under-dilated) with
•
respect to vessel diameter, in order to achieve optimal stent
deployment, inflate the balloon once more with the same
delivery system or perform a post dilatation using a non-
compliant high-pressure balloon. Use multiple fluoroscopy
views to ensure that the stent has been completely expanded.
7.5. Balloon deflation and catheter removal
1. Deflate the balloon in accordance with standard PCTA
procedures. Apply negative pressure to the balloon for about
30 sec. Ensure balloon is fully deflated before pulling the
catheter carefully out of the vessel.
2. Observation of the patient and angiographic evolution should be
performed periodically in the 15 minutes after stent implantation.
8 . MRI
The MGuard Prime stent was determined to be MRI-conditional
through non-clinical testing. A patient with this implant can be scanned
safely, immediately after placement under the following conditions:
1. Static magnetic field of 3 Tesla or less
2. Maximum spatial gradient magnetic field of 720 Gauss/cm
or less
The maximum temperature rise during MRI that was measured
was 2.2°C. MR image quality may be compromised if the area of
interest is in exact same area or relatively close to the position of
the MGuard Prime stent. Therefore, optimization of MR imaging
parameters to compensate for the presence of this implant may
be necessary
9. Pregnancy
This product has not been tested in pregnant women, women who
want to be pregnant, nursing mothers or in men intending to father
children, effects on the developing fetus have not been studied.
While there is no contraindication, the risks and reproductive
effects remain unknown.
10. Recommended storage
Store at room temperature and in a dry and dark place. For exact
values, see labeling.

11. Disposal instructions

After use, dispose the product and packaging in accordance with
hospital, administrative and/or local government policy.
MGuard Prime
|
PAC-0318-V4
12. Reprocessing
This MGuard Prime is designed and intended for single use only.
Reprocessing for secondary use may degrade the device integrity,
sterility and functionality and put the patient in risk. InspireMD
will not be responsible for any direct, incidental or consequential
damages resulting from reprocessing, resterilization or reuse.
13. Warranty/Liability
The product and each component of its system have been
designed, manufactured, tested and packaged with all reasonable
care. The warnings contained in InspireMD instructions for use are
expressly considered as an integral part of this provision. InspireMD
warranties the product until the expiration date indicated on the
same. The warranty is valid provided that the use of the product was
consistent with the instructions for use. InspireMD disclaims any
warranty of merchantability or fitness for a particular purpose of the
product. InspireMD is not liable for any direct, indirect, incidental
or consequential damages caused by the product. Except in the
case of fraud or grave fault on InspireMD part, compensation of
any damage to the buyer will not, in any event, be greater than the
invoice price of the disputed products. The guarantee contained in
this provision incorporates and substitutes the legal guarantees for
defects and compliance, and excludes any other possible liability
of InspireMD, however originating from its product supplied. These
limitations of liability and warranty are not intended to contravene
any mandatory provisions of law applicable. If any clause of the
disclaimer is considered by a competent court to be invalid or to be
in conflict with the applicable law, the remaining part of it shall not
be affected and remain in full force and effect. The invalid clause
shall be substituted by a valid clause which best reflects InspireMD
legitimate interest in limiting its liability or warranty. No person
has any authority to bind InspireMD to any warranty or liability
regarding the product.
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