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Cleaning Instructions (US/FDA)
Follow the instructions in this document. Any deviation by the processor from the instructions
provided should be evaluated for effectiveness and potential adverse consequences.
The internal paddles, including new paddles, must be thoroughly cleaned before sterilization.
The internal paddles may become contaminated with infectious materials including bloodborne
pathogens during use. Observe Universal Precautions and wear Personal Protective Equipment
(PPE) when handling the internal paddles after use.
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The internal paddles may be cleaned either manually, or by use of an automated washer.
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Air used for drying should be filtered in accordance with local requirements.
Warning
Possible Ineffective Cleaning. These internal paddles must be cleaned using only the validated
cleaning methods described. Do not use any other cleaning method.
Caution
Possible Damage to Internal Paddles. Do not use ultrasonic cleaners. Do no use abrasive cleaners.
Pre-Cleaning Inspection (US/FDA)
Before cleaning the internal paddles, follow the steps below.
1. Inspect the connector pins. If the pins are soiled, clean them carefully using cotton swabs
moistened with isopropyl alcohol or hydrogen peroxide. If necessary, a soft nylon brush may
be used to loosen any foreign materials. Do not use abrasive materials on the pins.
2. Inspect the following areas for deterioration or defects.
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Handles—splitting at the seams
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Connector—corroded, bent, or damaged pins
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Cable junctions—exposed wires, gaps, or loose connections
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Cables—cracks or exposed wires
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button—cracked or torn cover
SHOCK
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Electrodes—pitted, chipped, or scratched surfaces; cracks in the plastic coating
If any of these are found, remove the internal paddles from use immediately.
Note: Sterilization may cause discoloration over time. This is normal and does not affect
paddles function.
Procedures for manual and automated cleaning are provided in the following sections.
Sterilizable Internal Defibrillation Paddles Instructions for Use
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