St. Jude Medical Merlin PSA EX3100, Help Manual

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Merlin™ PSA Help Manual A-17
Sterilization
The goal is to render a device free from all forms of viable microorganism with a SAL of 10
-6
.
Equipment: Autoclave with vacuum complying with EN 285 or ANSI/AAMI ST8.
Instructions:
1. Seal the cable in a sterilization pouch suitable for moist heat sterilization.
2. Sterilize the Patient Cable Model EX3150 a minimum of four minutes at 134°C. Do not
exceed six minutes or 137°C.
Storage
Store the Patient Cable Model EX3150 in its sealed sterile pouch. See also Storage and Operating
Conditions .
Before Using
• Visually inspect for soil, damage, wear and corrosion.
• Check the connector to the Merlin PSA for smooth movement and proper locking.
• Ensure that lead connector clip functions well before starting the procedure.
Maintenance
Before using the Merlin PSA and any of its accessories, visually inspect the items for any damage.
The Merlin PSA and its accessories do not contain any user-serviceable parts. Preventive maintenance,
including periodic safety checks, is not required. Do not modify the Merlin PSA or its accessories. If
there is a problem with the Merlin PSA or its accessories, contact
Technical Support .
Disposal
The device contains a battery and the label is affixed to this device in accordance with European
Council Directives 2002/96/EC and 2006/66/EC.These directives call for separate collection and
disposal of electrical and electronic equipment and batteries. Sorting such waste and removing it from
other forms of waste lessens the contribution of potentially toxic substances into municipal disposal
systems and into the larger ecosystem. Return the device to St. Jude Medical at the end of its operating
life.
Note
• The sterilization process must be validated according to
ISO 17665-1.
• Prolonged sterilization time or increased temperature will
reduce the expected life of the product.
• Use demineralized water (less than 20 µS).
• Ensure that the autoclave´s maximum load is not exceeded.