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EnSite Precision™ Surface Electrode Kit
Instructions for Use
Description
The EnSite Precision™ Surface Electrode Kit is used to transmit information from the patient to the EnSite Precision™ Cardiac Mapping System for
signal conditioning and data inference. The kit contains the following single-use, non-sterile devices for use in conjunction with the EnSite Precision™
Cardiac Mapping System:
Device
Model
EnSite™ System Reference
SYS-REF-V1
Electrode
3M‡ Red Dot‡ Radiolucent
2570-5
Monitoring Electrodes
EnSite™ Locating
SURF-ELEC-2PRS
Electrodes
Indications for Use
Device
Indications for Use
EnSite Precision™
The EnSite Precision™ Surface Electrode Kit is indicated for use with the EnSite Precision™ Cardiac Mapping System in
Surface Electrode Kit
accordance with the EnSite Precision™ Cardiac Mapping System indication for use.
EnSite™ System
The EnSite™ System Reference Electrode is indicated for use with the EnSite™ Cardiac Mapping System in accordance with
Reference Electrode
the EnSite™ Cardiac Mapping System indication for use.
3M‡ Red Dot‡
The 3M‡ Red Dot‡ 2560 and 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570
Radiolucent Monitoring
electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be
Electrodes
used for short term and long term (up to 5 days) monitoring.
EnSite™ Locating
The EnSite™ Locating Electrodes are indicated for use with the EnSite Precision™ Cardiac Mapping System in accordance
Electrodes
with the EnSite Precision™ Cardiac Mapping System indication for use.
Clinical Benefit
As supplementary devices, these products contribute to the realization of the intended clinical benefit of the primary, compatible EnSite™ Cardiac
Mapping Systems for which they support.
Contraindications
There are no known contraindications.
Precautions
Intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.
Store in a cool, dry, dark place. Inspect the packaging and surface electrode(s) prior to use.
Do not attempt to use this product prior to completely reading and understanding these Instructions for Use.
Do not alter device(s) in any way.
This device must be operated by, or under the supervision of, an electrophysiologist trained in the operation of this device and supported by other
qualified personnel trained in the field of cardiac EP.
Do not warm surface electrode(s) before positioning on the patient.
Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, the "use by" date has passed or the gel column is
dislodged from the electrode.
Before applying the surface electrode(s), ensure that the application sites are hair-free, clean, non-irritated, and dry, to prevent receiving low
quality signals from body surface electrodes. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.
It is recommended to avoid removing the liner until the surface electrode is ready to be placed on the patient. Once the liner has been removed,
do not attempt to stick the liner back on the adhesive side of a surface electrode. Doing so may result in the liner becoming stuck to the surface
electrode.
To minimize the risk of electric shock, make sure that electrodes and lead connectors do not contact one another or contact ground. Use care
when attaching the ECG electrodes to lead connectors.
For proper skin management and to minimize skin irritation, do not abrade skin more than one time.
During surgical procedures, place ECG electrodes as far as possible from the electrosurgical site to minimize RF current flow through the
electrode site. Otherwise burns could result at the ECG electrode site.
Discontinue use of this product if skin sensitivity is observed.
Quantity
Description
One (1)
A reference electrode enclosed between adhesive foam and a layer of silver
carbon film and conductive hydrogel with an integrated cable. The EnSite™
System Reference Electrode serves as a system electrical reference for
impedance and ECG measurements.
Two (2) Packs -
Self-adhesive, non-sterile, single use disposable ECG electrodes which
Ten (10) total ECG
include a silver/silver chloride sensing element and conductive sticky gel.
electrodes
One (1)
The EnSite™ Locating Electrodes consist of the following:
- EnSite Precision™ Surface Electrodes (Six (6)) – An electrode
enclosed between adhesive foam and a layer of silver carbon film
and conductive hydrogel. The electrodes are color-coded and have a
placement diagram printed on the surface. The electrodes serve as
diagnostic tools that impart low-intensity alternating currents
generated by the EnSite Precision™ system to the patient's thorax
and sense the resultant electrical potentials which supports the
acquisition of impedance signals used for locating the position of
electrodes on conventional EP catheters.
- Patient Reference Sensor (PRS) Patches (Two (2)) - A foam adhesive
patch that is intended to hold a PRS in a stable position on the
patient during an EnSite Precision™ Cardiac Mapping System
procedure.
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