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NOTES:
Avoid removing and repositioning the PRS patch.
The PRS patch must be placed with the PRS wire channel pointed toward the patient's head.
3.
For each of the two PRS patches, remove the liner from the front of the PRS patch, exposing the adhesive. This is where the PRS will be placed.
PRS Patch Removal
1.
Peel off each PRS patch from the body using the white foam pull tab, leaving the PRS attached.
2.
Release the PRS from the PRS patch by grasping and pulling the white foam pull tab and the colored pull tab in opposite directions.
3.
Remove the PRS and dispose of the PRS patch.
Surface Electrode Removal
To minimize skin trauma during ECG electrode removal, pull up slowly and gently from the edge of the ECG electrode.
When removing EnSite Precision™ Surface Electrodes and the EnSite™ System Reference Electrode, slowly pull back at a low angle with one hand while
holding the skin taut with the other hand.
NOTE: Soap and water may aid in surface electrode removal.
Disposal
The IFU is recyclable.
After use, device(s) and packaging should be appropriately classified for disposal, e.g. electrical equipment, non-hazardous waste, etc. and
carefully disposed of in compliance with facility procedures and applicable laws and regulations. Discard any unused components after the
procedure.
Reporting Device Incidents
The user and/or patient should report any serious incident that has occurred in relation to this product to the manufacturer and the competent authority
of the Member State in which the user and/or patient is established. Manufacturer contact information is located on the back cover of this IFU.
Limited Warranty
Abbott Medical warrants that its products shall be free from defects in materials and workmanship under normal use. This warranty does not exceed the
"Expiration" date stated on any product labeling. The authorized uses and approved methods of use of each of our products is set forth in the related
"Instructions for Use" that accompany each product. Abbott Medical disclaims any responsibility and liability for the use of its products in a manner that
has not been authorized or approved. Abbott Medical's liability under this warranty is limited to replacing its products. The foregoing warranty excludes
and is in lieu of all other warranties whether expressed or implied including, but not limited to, any implied warranties of merchantability or fitness for a
particular purpose. Abbott Medical disclaims any liability for any incidental or consequential loss, damage, or expense directly or indirectly arising from
the use of this product, other than as expressly provided by specific law. Abbott Medical neither assumes nor authorizes any other person to assume for
it any other or additional liability for loss, damage, or expense in connection with this product. For more details please review complete Abbott Medical
warranty policy available from Abbott Medical or on the back of an Abbott Medical invoice.
Symbols
Symbol
Description
Assembler of Procedure Pack
Surface Electrode Kit
Locating Electrodes
System Reference Electrode
Radiolucent Monitoring Electrode
Medical Device
Unique device identification number
Importer
Not made with natural rubber latex.
"The Green Dot" trademark on packaging means that for such packaging, a financial contribution has
been paid to a national packaging recovery company that has been set up in accordance with the
principles defined in European Directive No. 94/62 and the corresponding national law.
Affixed to this device in accordance with European Council Directive 2012/19/EU.
This directive calls for separate collection and disposal of electrical and electronic equipment. Sorting
such waste and removing it from other forms of waste lessens the contribution of potentially toxic
substances into municipal disposal systems and into the larger ecosystem.
European conformity
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