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COMPATIBILITY
IntelliVue ECG lead sets and trunk cables can be used with any ECG monitor/defibrillator for which they
are listed as accessories in that product's IFU. Ensure that lead sets are plugged into appropriate trunk
cables designed for the same number of leads. Incompatible components may result in performance issues.
WARNINGS
• Attach all applicable labels included with these products to the cables/connectors.
• Always clean/disinfect patient cables when they are removed from their packaging for first-time use.
• Before use, read and understand all warnings listed in this IFU. Also refer to the IFU for the monitor/
defibrillator for additional warnings and cautions.
• Refer to the monitor/defibrillator IFU for information regarding proper lead/electrode placement that
complies with standard AAMI or IEC practices.
• Do not use any lead set or cable when visual inspection reveals liquid/lint contaminants in cable
connectors, or other visual cable damage.
• Ensure that leads are securely connected to the trunk cable, and the trunk cable is properly plugged into
the monitor/defibrillator. Otherwise incorrect patient physiological data my result.
• Ensure that the patient is properly grounded during Electro-Surgery (ESU) procedures to prevent patient/
user injury (i.e. electrical shock).
• These cables are not suitable for use in an MRI environment as there is the potential for patient burns.
• To avoid patient injury, ensure that cables are carefully positioned to avoid entanglement, choking, and
strangulation.
• When used to monitor ECG in the OR, ensure that you use accessories that provide appropriate ESU
protection (orange OR lead sets, or ICU lead sets paired with Philips OR trunk cables 989803170171 or
989803170181) to prevent patient injury (i.e. burns).
• OR lead sets and/or OR trunk cables cannot be used to measure respiration.
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 connectors 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 18 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 below.
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 patient monitor IFU for information regarding proper ECG lead/electrode
placement that complies with standard AAMI or IEC practices.
CABLE CLEANING AND DISINFECTION
Refer to the document titled Cables and Lead Sets Care, Cleaning, and Disinfection that accompanies this
IFU for validated cleaning/disinfecting agents and procedures. To reduce risk of cross-contamination:
• Clean/disinfect cables before first-time use and before use for a different patient.
• Clean/disinfect reusable cables that are applied to any patient, if they become visibly soiled.
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