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EN Instructions for Use
ASSOCIATED DOCUMENT
Refer to the ECG Lead Sets, Cables and Adapter Cables Care, Cleaning and Disinfection document that
accompanies this Instructions for Use (IFU) for validated lead set and cable cleaning/disinfecting agents
and procedures.
INTENDED USE
Efficia reusable ECG lead sets/cable are limited by the indications for use of the connected monitoring or
diagnostic equipment and are intended for use only by healthcare professionals. The reusable ECG lead sets
and cable are for multiple patient use and indicated for monitoring cardiac signals for both diagnostic and
monitoring purposes in adult and pediatric patients.
Indications for Use
Efficia reusable ECG lead sets/trunk cable are indicated for continuous monitoring of cardiac signals for
both diagnostic and monitoring purposes. These devices are limited by the indications for use of the
connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to
interact with patient intact skin only.
Contraindications
There are no known contraindications.
PRODUCT DESCRIPTIONS
Efficia reusable ECG lead sets/cable are available with one trunk cable and a choice of ECG lead sets.
Refer to page i for a list of product configurations with the following information:
Catalog reference numbers
AAMI
A check mark indicates AAMI color coding
IEC
A check mark indicates IEC color coding
3 ECG or
Defines the number of leads on the grabber connector
5 ECG
Total lead set/cable length
COMPATIBILITY
Efficia reusable ECG lead sets/cable are compatible only with Philips Efficia Models 863300, 863301,
863302, 863303, 863304, 863310, 863311, 863320, 863321, 863322, 866199 monitors and defibrillator/
monitors, plus any other Philips device that lists them as accessories in the device's Instructions for Use.
WARNINGS
• Always clean/disinfect patient lead sets and cable 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 may result.
• Ensure that the patient is properly grounded during Electro-Surgery (ESU) procedures to prevent patient/
user injury (i.e. electrical shock).
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