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Indications for Use PILLING® Vascular Clamps are devices intended for temporary occlusion of blood vessels during open vascular or minimally invasive coronary surgical procedures. Caution:
Federal U.S. laws restrict this device to sale, distribution, and use, by, or on the order of a physician.
Warning:
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination.
Instructions for Use Warning: Remove all protective caps and sheaths carefully. Prior to surgical use, the instrument must be cleaned, lubricated, decontaminated, sterilized and inspected. Instruments are reusable and supplied as non-sterile. Attention: Risk of damage - The vascular clamp is a precision device. Careful handling is important for the accurate functioning of the product. Improper external handling (e.g. bending, banging, dropping, etc.) can cause product malfunction. Control function before use: Before using, the general functioning and preparation of the instrument and accessories must be controlled. Please confirm prior to use. Operation: Cardiovascular procedures should be performed only by persons having adequate training and familiarity with cardiovascular techniques. In addition, consult medical literature relative to techniques, complications and hazards prior to performance of any cardiovascular procedure. Before using the product, all instructions regarding its safety features as well as surgical techniques must be read carefully. Vascular clamps must be sterilized before insertion into the body. The instrument must be operated only by trained personnel. Please observe general operating room technique.
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Decontamination / Cleaning / Sterilization Decontamination: Take the device with the adapter(s) and accessories to the decontamination area. Clean, decontaminate, and sterilize the device, adapter(s), and accessories following the instructions in the IFUs. Warning - Risk of infection: Before use, the entire device, including its accessories must be decontaminated. Inadequate, incorrect, or superficial decontamination can create a serious risk of infection in patients and/or users. Cleaning: Clean the instrument externally with a soft sponge and a soft brush. Sterilization: Autoclave sterilization: Use steam autoclave sterilization only. Standard autoclave cycle. Steam sterilize at 270oF for fifteen (15) minutes. Other time and steam temperature cycles may also be used. However, user must validate any deviation from the recommended time and temperature. (Note: Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times.) Caution: Autoclave temperatures should not exceed 280oF. Make certain that the instrument container is sealed in appropriate packaging for sterilization. Sterilize in compliance with the local guidelines for hospital hygiene. PILLING® instruments are reusable and meet AAMI standards for sterilization. Maintenance: Attention: Apply lubricant only on the connecting elements (locking mechanism) and moving parts. Repair: To ensure that all repairs are completed according to the manufacturer's specifications, the precision device should repaired by PILLING® or by an authorized service agency only. Warranty: All PILLING® products are guaranteed to be free from defects in material and workmanship at the time of shipping. All of our products are designed and manufactured to meet the highest quality standards. We cannot accept liability for failure of products which have been modified in any way from their original design.
NOTE: IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT, MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT. THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS. LIKEWISE, ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES.
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Explanation of Symbols Symbol
Title and Translations
Manufacturer
Lot Number / Batch Code
Catalogue Number
Consult Instructions for Use
Non-Sterile
Federal Law (USA) restricts this device to sale by or on the order of a physician
www.teleflex.com/ifu
MANUFACTURED FOR:
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