Mri Safety Information; Prior To Use - Steris Padlock Clip C910001 Instrucciones De Uso

MRI Safety Information

A patient with this device can be safely scanned in an MR system meeting the following conditions.
Non-clinical testing has demonstrated the Padlock Clip
implants are MR Conditional
Name/Identification of device
Nominal value(s) of Static Magnetic Field [T]
Maximum Spatial Field Gradient [T/m and gauss/cm]
Maximum MR System Whole-Body averaged specific absorption
rate (SAR) [W/kg]
Limits on Scan Duration
MR Image Artifact
• Possible Complications:
Symptoms
No Tissue approximation
No clip deployment
Leakage from defect
Poor or no closure
o Lesions located in the esophagus and the lesser curvature of the stomach may be difficult to treat due to endoscope
articulation and positioning that is required.
o Clipping hardened or severely fibrotic lesions to achieve hemostasis may be more difficult.
Re-bleeding may occur if clip detaches.
o
o The use of clips in the presence of bacterial contamination may increase or prolong infection.
o Although rates of occurrence are low, recurrent bleeding, ineffective clipping or endoscopic complications could result in
the need for surgery.
Contraindications:
1. Those specific to any endoscopic procedure.
2. Those specific to any endoscopic procedure requiring the use of a clip.
3. When hemostasis or closure cannot be verified with an endoscopic field of view.
4. On arteries greater than 2mm.
5. On polyps greater than 1.5cm in diameter.
6. Mucosal/Submucosal defects greater than 3cm.
7. Treatment of esophageal varices.
8. Securing stents intended for short term therapy.
9. Patients with a known nickel allergy.
Directions for Device Usage:

Prior to use:

1. Perform initial surveillance endoscopy to uncover any anatomical concerns and location of defect to be treated prior to using the
Padlock Clip defect closure system.
®
2. Inspect and familiarize yourself with the device and read all the Instructions for Use.
3. Read the "Warnings, Precautions and Contraindications" and review the figures below.
Open pouch and remove device. See Figure 2.
4.
732380 Rev. K
MRI Safety Information
Failure to follow these conditions may result in injury to the patient.
defect closure system and Padlock Clip Pro-Select
®
Diagnostic
Clip not visible on tissue
Closure is incomplete
Clip position misfire
Padlock Clip ® defect closure system
Padlock Clip Pro-Select ® defect closure system
1.5T and 3.0T
19T/m (1,900 gauss/cm)
2 W/kg
Under the scan conditions defined above, the implant is
expected to produce a maximum temperature rise of less than
3.0°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device
extends radially up to 6mm or 9mm from the device when
imaged with a gradient echo pulse sequence in a 1.5T or 3.0T
MR system, respectively.
DO NOT pull back on Thumb Actuator. Carefully remove
from patient and return entire device to STERIS Endoscopy
and use a second device
Engage more tissue and place a second clip next to the first
Follow best practices for endoscopic removal of foreign bodies
or leave in-situ to release with time. Place a second clip
defect closure system
®
Treatment
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