Cook Medical adheres to the F2503-08 standard of MR (magnetic resonance) terminology adopted by the American Society for Testing and Materials (ASTM). This practice of marking medical devices came about in an effort to clarify the terminology, provide a uniform system for marking and, more important, because misuse of old terminology could result in serious injuries for patients and other individuals. This new system references the MR environment where testing took place, which includes field strength, spatial gradients, dB/dt (time rate of change of the magnetic field), radio frequency (RF) fields and specific absorption rate (SAR).

Taking these conditions into consideration, three new categories of MR marking exist: MR Safe, MR Conditional, and MR Unsafe. In this system, “safe” and “unsafe” are the two extremes. “Conditional” is in the middle and characterizes the behavior of a medical device under specific conditions in the MR environment as determined by testing. In addition to the new terms, the ASTM International document introduced corresponding icons consistent with international standards for colors and shapes of safety signs. The icons are intended for use on items that may be brought into or near the MR environment as well as in product labeling. The new terminology and icon structure is intended to help clarify matters related to biomedical implants and devices to ensure the safe use of MRI technology.

	MR Safe—An item that poses no known hazards in all MR environments. MR Safe items include nonconducting, nonmetallic, nonmagnetic items such as plastic, silicone and glass. An item may be determined to be MR Safe on the basis of scientific rationale rather than test data.
	MR Conditional—An item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Field conditions should be enumerated on the product, its packaging or in the enclosed literature. Additional conditions, including specific configurations of the item, may be required.
	MR Unsafe—An item that is known to pose hazards in all MR environments. MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors.

Conichrome is a trademark of Carpenter Technologies.
Inconel is a registered trademark of Huntington Alloys Corporation.

Nonclinical testing has demonstrated that the Cook Celect Vena Cava Filter is MR Conditional according to ASTM F2503. A patient with a Cook Celect Vena Cava Filter can be scanned safely under the following conditions:

• Static magnetic field of 1.5 tesla or 3.0 tesla
• Maximum spatial magnetic gradient of 1,600 gauss/cm (16.0 T/m) or less
• Normal operating mode
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
1.5 Tesla Temperature Rise
In nonclinical testing, the Cook Celect Vena Cava Filter produced a maximum temperature change of 3.7 °C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 1.5 tesla MR system (1.5 tesla/64 MHz, Siemens Magnetom Avanto®, Numaris/4 syngo® MR B17) at an MR system-reported whole-body-averaged SAR of 2.05 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.75 W/kg).

3.0 Tesla Temperature Rise
In nonclinical testing, the Cook Celect Vena Cava Filter produced a maximum temperature change of 4.2 °C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 3.0 tesla MR system (3.0 tesla/128 MHz, Siemens Magnetom Trio®, A Tim System, Numaris/4 syngo MR B17 at an MR system-reported whole-body-averaged SAR of 2.08 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.71 W/kg).

Image Artifacts
MR image quality may be compromised if the area to be scanned is within approximately 21 mm of the position of the Cook Celect Vena Cava Filter. This 21 mm range is based on nonclinical testing with T1-weighted spin-echo and gradient-echo pulse sequences in a 3.0 tesla MR system (Excite, GE Healthcare). If you need to scan an area within 21 mm of the filter, you may have to optimize MR imaging parameters to compensate for the presence of this metallic filter.

For U.S. Patients Only
Cook recommends that the patient register these MR conditions with the MedicAlert Foundation. The MR conditions disclosed in this document are taken from the product IFU. The contact information for the MedicAlert Foundation is below:

For patients implanted with stainless steel coils, recent testing shows that these coils are MR Conditional.

Nonclinical testing has demonstrated that the standard embolization coil (Stainless Steel) is MR Conditional according to ASTM F2503. A patient with this coil may be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 tesla or less
• Maximum spatial magnetic gradient of 1,600 gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg normal operating mode for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In nonclinical testing, the standard embolization coil (stainless steel) produced a maximum temperature rise of 1.8 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 tesla system (General Electric Excite, Software 14X.M5) at an MR system reported whole-body-averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole-body-averaged value of 2.7 W/kg).

Image Artifact
MR image quality may be compromised if the area of interest is within approximately 75 mm of the position of the standard embolization coil (stainless steel) as found during nonclinical testing using T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 tesla MR system (Excite, General Electric Healthcare, Milwaukee, WI). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this coil.

For U.S. Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Nonclinical testing has demonstrated that the Formula biliary stent is MR Conditional. A patient with this stent may undergo MRI immediately after placement under the following conditions:

• Static magnetic field of 3.0 tesla or less
• Maximum spatial gradient magnetic field of 720 gauss/cm
• Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning

In nonclinical testing, the Formula biliary stent produced a temperature rise of less than 1°C at an MR-system-reported maximum whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 tesla system (Excite, Software G3.0-052B, GE Healthcare).

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Formula biliary stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant. The effect of heating in the MRI environment for overlapping stents or stents with fractured struts is unknown.

Non-clinical testing has demonstrated that the Formula Renal stent is MR Conditional according to ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. A patient with this stent can be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3-Tesla or 1.5-Tesla
• Maximum spatial magnetic gradient of 720 Gauss/cm or less
• Product of the spatial gradient and the static magnetic field of 21.6 T²/m or less
• MR system reported whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg or less for 15 minutes of scanning

Non-clinical evaluation was conducted in an MR system (Excite, General Electric Healthcare) with a maximum spatial magnetic gradient field of 720 Gauss/cm as measured with a gaussmeter in the position of the static magnetic field pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual). In non-clinical testing, a single and two overlapped Formula Renal stents produced a maximum temperature rise of 2.6 °C and 3.3 °C, respectively, during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 3 Tesla MR system (3 Tesla/128 MHz, Excite, Software G3.0-052B, General Electric Healthcare) at an MR system reported whole-body-averaged SAR of 3.0 W/kg (associated with a calorimetry measured whole-body-averaged value of 2.8 W/kg). The effect of heating in the MRI environment for stents with fractured struts is unknown.

Image Artifact
MR image quality may be compromised if the area of interest is within the lumen or within approximately 15 mm of the Formula Renal stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic stent.

MedicAlert Foundation
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted at:

Nonclinical testing has demonstrated that the Günther Tulip Vena Cava Filter is MR Conditional according to ASTM F2503. A patient with a Günther Tulip Vena Cava Filter can be scanned safely under the following conditions:

• Static magnetic field of 1.5 tesla or 3.0 tesla
• Maximum spatial magnetic gradient of 1,600 gauss/cm (16.0 T/m) or less
• Normal operating mode
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
1.5 Tesla Temperature Rise
In nonclinical testing, the Günther Tulip Vena Cava Filter produced a maximum temperature change of 3.8 °C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 1.5 tesla MR system (1.5 tesla/64 MHz, Siemens Magnetom Avanto®, Numaris/4 syngo® MR B17) at an MR system-reported, whole-body-averaged SAR of 2.05 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.75 W/kg).

3.0 Tesla Temperature Rise
In nonclinical testing, the Günther Tulip Vena Cava Filter produced a maximum temperature change of 5.2 °C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 3.0 tesla MR system (3.0 tesla/128 MHz, Siemens Magnetom Trio®, A Tim System, Numaris/4 syngo MR B17) at an MR system-reported whole-body-averaged SAR of 2.08 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.71 W/kg).

Image Artifacts
MR image quality may be compromised if the area to be scanned is within approximately 21 mm of the position of the Günther Tulip Vena Cava Filter. This 21 mm range is based on nonclinical testing with T1-weighted spin-echo and gradient-echo pulse sequences in a 3.0 tesla MR system (Excite, GE Healthcare). If you need to scan an area within 21 mm of the filter, you may have to optimize MR imaging parameters to compensate for the presence of this metallic filter.

For U.S. Patients Only
Cook recommends that the patient register these MR conditions with the MedicAlert Foundation. The MR conditions disclosed in this document are taken from the product IFU. The contact information for the MedicAlert Foundation is below:

Nonclinical testing has demonstrated that the Gianturco-Roehm Bird's Nest Vena Cava Filter is MR Conditional. According to the article “MR Imaging of the Bird's Nest Filter” by Alyssa T. Watanabe, “No complication or symptomatic filter displacement was encountered as a result of MR imaging performed at 1.5 T.” The article also states that the filters created significant local artifact distortion on MR images; however, diagnostic images of the pelvis, spine and brain may still be obtained.

MRI diagnostic procedures should be postponed for six weeks following filter implantation to ensure device incorporation into the vessel wall.

Non-clinical testing has demonstrated that the Hilal Embolization Microcoil™ is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non-clinical testing, the embolization coil produced a maximum temperature rise of 1.6 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14X.M5) at an MR system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg).

Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Hilal Embolization Microcoil™, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Non-clinical testing has demonstrated that the MReye® Embolization Coil is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely immediately after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non-clinical testing, the MReye® Embolization Coil produced a maximum temperature rise of 1.6 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14X.M5) at an MR system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg).

Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 12 mm of the position of the MReye® Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Non-clinical testing has demonstrated that the MReye Flipper® Detachable Embolization Coil is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non-clinical testing, the embolization coil produced a maximum temperature rise of 1.6 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14X.M5) at an MR system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg).

Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 12 mm of the position of the MReye Flipper® Detachable Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Non-clinical testing has demonstrated that the Nester® Embolization Coil is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non-clinical testing, the Nester® Embolization Coil produced a maximum temperature rise of 1.6 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14X.M5) at an MR system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg).

Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Nester® Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Non clinical testing has demonstrated that the Retracta Detachable Embolization Coil is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non clinical testing, the Retracta Detachable Embolization Coil produced a maximum temperature rise of 1.1 °C (scaled to an SAR of 2.0 W/kg) during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3.0 Tesla System (General Electric Excite, HDx, Software 14X.M5).

Image Artifact
MR image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Retracta Detachable Embolization Coil, as found during non clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Non-clinical testing has demonstrated that the Tornado® Embolization Coil is MR Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In non-clinical testing, the embolization coil produced a maximum temperature rise of 1.6 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14X.M5) at an MR system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg).

Image Artifacts
MR image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Tornado® Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a MR 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic embolization coil.

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Nonclinical testing has demonstrated that the Zilver Self-Expanding Stent is MR Conditional. It can be scanned safely under the following conditions:

• Static magnetic field of 3 tesla or less
• Spatial gradient field of 720 gauss/cm or less
• Whole-body averaged specific absorption rate (SAR) of 1.5 W/kg (for a single stent at 1.5 tesla) and 3 W/kg (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla) for 20 minutes (for a single stent at 1.5 tesla) and 15 minutes of scanning (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla), respectively.

In nonclinical testing, the Zilver Self-Expanding Stent produced maximum temperature rises of 0.1, 3.8, 0.8, and 0.1 degrees C (for a single stent at 1.5 tesla, a pair of overlapping stents at 1.5 tesla, a single stent at 3 tesla, and a pair of overlapping stents at 3 tesla, respectively) at whole-body averaged specific absorption rates (SAR) of 1.5 W/kg (for a single stent at 1.5 tesla) and 3 W/kg (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla) for 20 minutes (for a single stent at 1.5 tesla) and 15 minutes (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla) of MR scanning in a 1.5 tesla/64 MHz GE Healthcare MR scanner, a 1.5 tesla Magnetom Siemens Medical Solutions MR Scanner (to evaluate a pair of overlapping stents), and a 3 tesla Excite GE Healthcare MR scanner.

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Zilver Self-Expanding Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

Heating in the MRI environment for stents with fractured struts is not known.