Continuity Tests; Storage Instructions - Physio Control 11131-000040 Instrucciones De Uso

Care and Storage

Continuity Tests

To ensure reliable performance, perform continuity tests of the connector pins before the
internal paddles are sterilized for the first time. After the first sterilization cycle, perform
continuity tests every 3 months or every 25 sterilization cycles, whichever occurs first. See
Continuity Test Procedures (on page 19) for instructions.
After testing, clean and sterilize the internal paddles according to the instructions in this manual.
Sterilization
The internal paddles are shipped nonsterile. Clean and sterilize the paddles before the first use,
after each time the paddles are used, and whenever the sterile packaging is compromised. See
Cleaning Instructions (US/FDA) (on page 21) or Cleaning Instructions (Alternate/CE) (on page 26)
for cleaning procedures. See Sterilization Instructions (US/FDA) (on page 24) or Sterilization
Instructions (Alternate/CE) (on page 28) for sterilization procedures.
Caution
Possible Damage to Internal Paddles. Use only one of the recommended sterilization methods
for the life of each internal paddles set. Using more than one sterilization method may invalidate the
product certifications.

Storage Instructions

To prevent damage to the cables, always store internal paddles with the cables loosely coiled.
The diameter of the coiled cable should be at least 15 cm (6 in).
Protect the paddle surfaces from impact with each other or hard surfaces to prevent possible
damage and subsequent failure.
Long-term storage temperature: 0° to 45°C (32° to 113°F), or according to your facility's sterile
product storage requirements.
After internal paddles are sterilized, store with sterilization wrapping intact. Internal paddles that
are sterilized with STERRAD products should be stored in sterilization container systems such
as wrapped, perforated, instrument cassettes in accordance with your facility's sterilization
processing requirements and the sterilization equipment manufacturer's instructions.
Sterilization wraps must be cleared by the FDA or approved by equivalent regulatory authority
for your country, for the sterilization method used.
Note: Hydrogen Peroxide Vapor Sterilization has not been cleared for CE marking.
14
Sterilizable Internal Defibrillation Paddles Instructions for Use