Warnings And Precautions - Steris Padlock Clip C910001 Instrucciones De Uso

Warnings and Precautions:

Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. STERIS Endoscopy did not design this device,
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nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this disposable
medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
Follow universal precautions, use appropriate infection control principles and wear appropriate PPE.
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• Consult the medical literature relative to techniques, technical principles, clinical applications, complications, risks, and hazards
prior to the performance of any endoscopic procedure.
• Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques
including those specific to over the scope clipping.
• The Padlock Clip ® defect closure system is supplied sterile.
o Carefully examine system to verify that neither the contents nor the package has been damaged in shipping. If damage is
evident (such as bent or kinked Linking Cable, or cracked, broken, protruding, or missing parts of the Delivery
Housing or Control Handle Body or Thumb Actuator), do not use this product and contact your local STERIS
Endoscopy Product Specialist or Customer Service Representative.
The Padlock Clip ® defect closure system is compatible with a wide range Gastroscopes and Colonoscopes.
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Consult product label and above chart for size details.
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o Check to ensure the distal tip diameter of the endoscope is within 9.5mm to 14mm before mounting the Padlock Clip
closure system.
• Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip does not
release completely from the delivery system or if any other unexpected circumstance takes place.
• Operation of this instrument is based on the assumption that the end user is trained in techniques necessary for the associated
endoscopic therapeutic use of an over the scope clip and its potential adverse events.
• The Safety Cap (See Figures 2, 7) assists in safe handling during attachment of the delivery system to the endoscope.
Do not remove the Safety Cap until the Padlock Clip
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and the entire system is ready to be inserted into the patient.
Care should be taken after removal of the Safety Cap.
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o Hands and fingers are to be kept clear from the Delivery Housing distal tip area so that personal injury to medical staff does
not occur.
o Inspect the Padlock Clip
the clip's points extend beyond the distal rim/edge. See Figure 7.
If any clip points extend beyond distal rim/edge, carefully replace safety cap, DO NOT use this product,
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contact your local STERIS Endoscopy Product Specialist or Customer Service Representative, and use a
different device for procedure.
Once the Handle Stay (See Figure 2) is removed, keep hands and fingers clear from the Delivery Housing distal tip so that an
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accidental release of the Padlock Clip
Once the Handle Stay is removed, use caution in handling Thumb Actuator button (See Figure 2) to prevent inadvertent deployment of
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the clip.
Pass endoscope loaded with the Padlock Clip
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of mucosal injury.
• Use caution and do not force endoscope loaded with Padlock Clip
undersized anatomy to minimize risk of mucosal injury.
• Use cautiously in patients that are combative and uncooperative.
This device has not been evaluated on pediatric populations.
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• This device contains nitinol, an alloy of nickel and titanium.
Persons with allergic reactions to these metals may suffer an allergic reaction to this implant.
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o Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for
allergy/hypersensitivity to these materials.
732380 Rev. K
defect closure system is positioned, mounted and secured to the endoscope
®
® defect closure system Delivery Housing closely, and circumferentially, to make sure that none of
® does not result in personal injury.
® delivery system cautiously through cricopharyngeal area of patient to minimize risk
® delivery system through any stenosis or any area of known
® defect
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