PARAMETERS |
|
VALUES |
Dimensions |
: |
Length : 23 cm, Width: 14cm,
Depth:0,2cm |
Weight |
: |
70gr (+/- 2,1gr) |
Shipping weight |
: |
90gr (+/- 2,7gr) |
PH |
: |
6,5 – 6,7 |
Odour |
: |
Characteristic and sharp |
Colour |
: |
Yellow – light green |
Shipping / Storage Temperature |
: |
+4˚C to 25˚C |
Shelf life |
: |
1 year following production |
Medical Device
Classification |
: |
Class IIb
per Medical Device Directive 93/42/EEC |
CE MARK |
: |
YES |
Certificate of
Conformity No |
: |
1783-MDD-006 |
Date of
Certification |
: |
30.09.2013 |
Date of
Certification Expiry |
: |
30.09.2018 |
Ensuring accurate diagnosis : The Patient must have accurate clinical diagnosis (including but not limited to MRI - Magnetic Resonance Imaging- and physical neurological exam) as the symptoms of disk hernia can also be caused by other reasons. Patients are advised not to accept a diagnosis based solely on findings from an MRI scan or other radiographic test.
Need for Patient’s MRI : These are required in order that exact location of herniated disk is determined and marked prior to ARTCURE® DP application.
Controlling Improvement : MRI taken before and after ARTCURE® DP application are essential for comparison and thus verification of improvement. MRI also reveals the level of disk herniation.
Patient’s eligibility for using the product : The Patient should not use the product in certain cases (see “Warnings and Contra-indications”). These conditions should be checked and detected by a physician, if any..
Expected product performance : ARTCURE® DP yields best results when disk hernia is not accompanied by one or more of foraminal stenosis, lumbar spinal stenosis, black disk, calcified disk hernia. The product can still provide improvement but physician’s diagnosis are essential for setting realistic expectations.
Controlling side effects and preparedness : Depending on the Patient’s individual conditions, the product may pose several side effects (see “Side Effects”). Consulting a physician before using the product will facilitate taking and applying precautions if required.
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