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• The Efficia lead sets and cable are not suitable for use in an MRI environment as there is the potential for
patient burns.
• Do not use Efficia lead sets and cable in the OR since this could result in incorrect physiological data or
patient burns at the electrode site.
• To avoid patient injury, ensure that the lead sets and cable are carefully positioned to avoid entanglement,
choking, and strangulation.
CAUTIONS
• Federal (US) law restricts this device to sale by or on the order of a medical practitioner.
• Do not use in excessively wet environments or under massive influence of fluids (e.g. rain).
• Do not immerse the cable connector in any fluid.
• Do not autoclave or use ultrasonic cleaners on the cable.
• Do not clean cable connector electrical contacts or connectors with bleach.
• Expected service life of these products is 12 months of typical clinical use.
• Do not disconnect a cable by pulling on the lead wires.
• Be sure to visually inspect the cable before attaching it to any patient or monitor/defibrillator. See
VISUAL INSPECTION PRIOR TO USE.
VISUAL INSPECTION PRIOR TO USE
Before attaching any cable to a patient or monitor, perform a visual inspection to determine if the cable has
reached end-of-life. Check for cracks, blisters, peeling, exposed wires, damaged connectors and similar
wear or damage that could compromise accurate readings or cause patient/user injury (e.g. cuts). Whenever
visual inspection reveals a cable is no longer suitable for continued use, follow appropriate product disposal
procedures (see PRODUCT DISPOSAL).
PATIENT APPLICATION, ECG LEADS
Refer to the compatible monitor IFU for information regarding proper ECG lead/electrode placement that
complies with standard AAMI or IEC practices.
CLEANING AND DISINFECTION
Refer to the document ECG Lead Sets, Cables and Adapter Cables Care, Cleaning, and Disinfection that
accompanies this IFU for validated cleaning/disinfecting agents and procedures. To reduce the risk of
cross-contamination:
• Clean/disinfect the lead sets and cable before first-time use and before use for a different patient.
• Clean/disinfect reusable lead sets and cable that are applied to any patient, if they become visibly soiled.
STERILIZATION
All lead sets and cable products described in this IFU are not intended to be sterilized.
PRODUCT DISPOSAL
Follow approved medical waste disposal methods as specified by your patient care facility or local
regulations.
INCIDENT REPORTING
Any serious incident that has occurred in relation to this device should be reported to Philips and the
competent authority of the European Economic Area (EEA) countries, including Switzerland and Turkey in
which the user and/or patient is established.
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