ERBE NESSY Omega Plates
Contents
1. OBJ DOKU 187952 003 fm Seite 1 Montag 14 April 2014 10 24 10 WZ Notes on use ERBE NESSY Omega Plates Disposable split return electrodes 20193 084 A A Z gt 5 LA e GH Gs e OBJ _ DOKU 187952 003 fm Seite 2 Montag 14 April 2014 10 24 10 Table of Contents U AUN 5 1 Opening the packaging 5 2 Check the expiration date 5 3 Pull off label for documentation purposes 5 4 Selecting a suitable application site 5 5 Preparing the application site 5 6 Attaching the return electrode 5 7 Reducing the risk of accidental tissue damage 5 8 Repositioning the patient during surgery 5 9 Removing the return electrode 6 Monitoring of the return electrode by the electro surgical unit ET AER am KE Normal Use es Safety 5 0 5 Product 15 Explanation of packaging symbols HOW to 255 0556 6 ay SN S e OBJ DOKU 187952 003 fm Seite 3 Montag 14 April 2014 10 24 10 e Gs IMPORTANT Please read all information carefully These notes on use do not replace the user manual of the elec trosu2. USA Territory ERBE Elektromedizin GmbH ERBE USA Inc Waldhornlestr 17 2225 Northwest Parkway 72072 Tubingen Germany Marietta GA 30067 Tel 49 7071 755 0 Customer Support 800 778 ERBE 3723 Fax 49 7071 755179 Tel 770 955 4400 EMail info erbe med com Fax 777 955 2577 www erbe med com EMail sales erbe usa com www erbe usa com 0124 ERBE Elektromedizin GmbH 30193 083 02 14 o Go e
3. e entire surface of the return electrode is applied on the skin of the patient Use light pressure to apply the electrode thereby ensuring good contact of the entire adhesive surface with the skin Make sure that there are no bubbles or folds be tween the skin and return electrode Do not use contact gel For return electrodes without an integrated cable use a match e ing ERBE connection cable order number see ERBE accessories catalog Insert the contact tab of the return electrode com pletely into the connecting clamp The contact tab must not touch the patient s skin because if it is in contact with the pa tient s skin during use a burn may occur Do not reapply or move a return electrode that has already been applied 5 7 Reducing the risk of accidental tissue damage When using the electrosurgical unit avoid lengthy activations The temperature increases under the return electrode with lengthy and continuous activations The patient is at risk of ac cidental tissue damage In this case make sure that there are sufficient cooling times between activations am be e 3 Gs The lowest possible settings of the electrosurgical unit should be used to achieve the desired clinical outcome Nonetheless prior to increasing the electrosurgical unit s power and or effect settings ensure that the return electrode has been correctly ap plied to the pa
4. oclave ERBE Elektromedizin expressly warns against modifying or cut ting the return electrode Any modification exempts ERBE Elek tromedizin from any and all liability 3 Product benefits An equipotential ring distributes the HF current and thereby the heat to both halves of the return electrode Due to its symmetry the return electrode can be oriented to the patient any way that is desired The contact gel overlaps all aluminum edges which reduces the heating of the edges of the return electrode The con tact gel also protects against fluids from penetrating under the return electrode The return electrode s surface is flexible and skin friendly Pull off label for documentation purposes Pull off tab to easily remove the return electrode from the protective film and skin The product is suitable for latex allergy sufferers It contains no latex and no typical natural rubber additives i e the re turn electrodes cannot trigger any allergic reactions to la tex ay SN S 4 Explanation of packaging symbols The following are some atypical symbols which may be encoun tered with a return electrode Please familiarize yourself with their meaning contains no latex and no typical natural rubber addi tives i e the return electrodes cannot trigger any al lergic reactions to latex The product is suitable for latex allergy sufferers It The pr
5. oduct can be used up to 14 days after Ch DS opening the sealed packaging Do not use the product after this period has lapsed 5 How to Use WARNING Return electrodes are part of a safety system The following in structions for use are therefore also safety instructions They must be strictly observed to prevent patients from being burned 5 1 Opening the packaging The return electrodes are not packaged sterile To open tear off the strip on the dispenser carton and open the pouch Once the pouch has been opened use the return electrodes within 14 days Always keep unused return electrodes in the pouch Reclose by folding over The film protects the return electrode from drying out Remove the protective film right before application otherwise the con ductive hydrogel will dry out and the return electrode will no longer be usable e 1 e OBJ_DOKU 187952 003 fm Seite 5 Montag 14 April 2014 10 24 10 e e OBJ_DOKU 187952 003 fm Seite 6 Montag 14 April 2014 10 24 10 e Gs 5 2 Check the expiration date An expiration date is indicated on the return electrode packag ing Never use return electrodes after the expiration date 5 3 Pull off label for documentation purposes The pull off and reattachable label can be used for documenta tion purposes e g for the patient file anesthesia record etc 5 4 Selecting a suitable application site Apply the return electrode to an appr
6. opriate vascularized area of muscle mass as close as possible to the surgical site follow ing A O R N Association of Operating Room Nurses recom mended practices In any case the application site must be on an intact skin surface Activation of the electrosurgical unit may affect the perfor mance of active implants e g pacemakers internal defibrilla tors etc or damage them In the case of patients having active Zei implants consult the manufacturer of the implant or the com petent department of your hospital prior to performing surgery Do not position the return electrode near pacemakers internal defibrillators or other active implants The return electrode should be closer to the surgical site than ECG electrodes The return electrode must not be applied on or over the follow ing locations e on hair e scars e on inflamed skin ay SN S EI e OBJ_DOKU 187952 003 fm Seite 7 Montag 14 April 2014 10 24 10 e SG e on bony parts of the body e over metal implants over severely adipose subcutaneous tissue e over sacrum hip buttocks shoulder blade 5 5 Preparing the application site Shave the selected skin surface Clean e g remove any lotions etc and dry the skin surface thoroughly 5 6 Attaching the return electrode Remove the protective film from the return electrode Ensure that th
7. rgical unit ESU used Read the user manual of the electro surgical unit and ask ERBE or your distributor in case of doubt Caution Federal law USA restricts this device to sale by or on the order of a physician 1 Normal Use These return electrodes are intended to be used for dispersing and as applicable monitoring High Frequency HF current during electrosurgical procedures when connected to an elec trosurgical unit ESU and applied to the skin of the patient Split return electrodes should be used with electrosurgical units that have a safety monitoring system 6 The return electrodes are to be connected to the electrosurgical 6 units specified in the declaration of conformity of the return electrodes only 2 Safety Instructions WARNING This product may only be used by medical personnel who have been trained per these instructions Check the insulation on the return electrode cable and plug for damage before use Never use damaged return electrodes cables or plugs ay SN S EI Gs e OBJ DOKU 187952 003 fm Seite 4 Montag 14 April 2014 10 24 10 e ERBE recommends that the product not be reprocessed after use Reprocessing can affect material properties and or product function making its Normal Use no longer possible Concerns involve Components connections that are damaged by high tem peratures e g in the aut
8. tient with good skin contact and verify that the connection to the electrosurgical unit is secure intact 5 8 Repositioning the patient during surgery Ensure that the return electrode does not become detached from the patient s skin or shears the skin when repositioning the patient Manually reinforce the pad when moving the pa tient 5 9 Removing the return electrode To avoid injuries to the patient s skin peel the return electrode off the skin carefully by pulling on the tab Never use the cable to remove the return electrode 6 Monitoring of the return electrode by the electrosurgical unit Electrosurgical units are equipped with various safety systems to ensure the correct use of the return electrode To best use these safety systems e Only use electrosurgical units which are listed as suitable in the declaration of conformity of the return electrodes e Get very familiar with the safety systems of the electrosur gical unit You can find information about the electrosurgi cal unit s safety system in the user manual EI L e OBJ_DOKU 187952 003 fm Seite 8 Montag 14 April 2014 10 24 10 e ay SN S e OBJ_DOKU 187952 003 fm Seite 9 Montag 14 April 2014 10 24 10 e ay SN S EI Z OBJ_DOKU 187952 003 fm Seite 10 Montag 14 April 2014 10 24 10 o Manufacturer Distributed by
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