Product Description - 3M 1182 Serie Bedienungsanleitung

3M ™ Electrosurgical Patient Plates 1182 and 8180F Series
General Use
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within this document and AORN recommended practices for electrosurgery. READ WARNING
Intended Use
3M™ Electrosurgical Patient Plates (1182 and 8180F) are designed to work with most electrosurgical units (ESUs) for virtually every surgical application
where electrosurgery is utilized to provide a safe return path for electrosurgical current. These split style electrosurgical plates are for use with ESUs that
have a Contact Quality Monitoring System (i.e., CQMS such as REM, ARM, NESSY etc.). Use of this product for unintended applications could lead to an
unsafe condition. The plates are to be used by healthcare professionals in hospitals and surgical centers.
• For patients 15kg or less use 3M™ Electrosurgical Patient Plate 1182, designed for use on pediatric patients, with an area of
10in (65cm ).
• For patients greater than 15kg use 3M™ Electrosurgical Patient Plates 8180F with an area of 20in (129cm ).

Product Description

3M™ Electrosurgical Patient Plates (i.e., grounding pads, neutral electrodes) consist of a conductive adhesive area surrounded by a
nonconductive border adhesive. The 1182 and 8180F patient plates are supplied non-corded. The 1182 has foam backing and the 8180F
has fluid resistant non-woven backing. The patient plates are single use, disposable and non-sterile.
WARNING
Improper use of Electrosurgical Patient Plates can cause electrosurgical burns or pressure necroses. For patient safety, follow all of the
instructions below. Failure to follow any of these instructions increases the risk of electrosurgical burns or pressure necroses.
Instructions for Safe Use
1. Use Appropriate Plates, Equipment, and Accessories
• Split-style plates are designed for use with electrosurgical generators that have a Contact Quality Monitoring
System (e.g. REM™, ARM™, NESSY™).
• For patients 15kg or less use 3M™ Electrosurgical Patient Plate 1182 that is designed for use on pediatric patients.
• Use ECG cables with RF suppressors/chokes to prevent electrosurgical current from flowing through the ECG
electrodes.
• Use 3M™ cables and adapters as required with 3M™ patient plates.
• Check expiration date on package. 3M™ patient plates are safe to use for 14 days after package is opened.
• To avoid risk of alternate site burns, do not allow the patient to contact earth grounded metal or items which are capacitively
coupled to earth ground.
• To avoid increased risk of burns and infection related to cross contamination, do not reuse pads.
2. To Reduce the Risk of Burns, Do Not Overload the Patient Plate with Too Much Current
• Do not activate the electrosurgical device or active accessory for more than 60 seconds in any 2-minute period, as this will
overload the patient plate with current and may result in a patient burn.
• Any combination of high power, long activation time, and a conductive irrigant (e.g., saline) may overload the patient plate
with current and may result in a patient burn. To reduce this risk:
o Use non-conductive solutions unless specific medical reasons indicate otherwise. Conductive fluids (e.g., blood or saline) in
direct contact with or near an active electrode may carry electrical current and/or heat away from target tissues, which may
lead to unintended burns to the patient.
o Use the lowest possible power setting.
o Use short activation times. If long activation is necessary, allow time between activations to allow the tissue under patient plate to cool.
o Use two patient plates with the Y-adapter.
o If you do not receive the desired surgical effect, stop and verify the correct distention/irrigation solution and good patient
plate contact before proceeding with electrosurgery or increasing the power setting.
3. Select an Appropriate Site
To reduce the risk of burns and pressure necroses:
• Select a smooth, well-vascularized, muscular area close to surgical site that allows full patient plate-to-skin contact.
• Site must be clean, dry, and free of hair. Remove hair at application site.
• Locate patient plate closer to the surgical site than to the ECG electrodes.
• Remove metal jewelry from patient.
• Avoid placement over bony prominences, metal prostheses, or scar tissue.
• Avoid placement such that current flows through a metal prosthesis or conductive implant. For patients with implanted devices,
contact device manufacturer for precautions to avoid interference.
• Avoid plate placement over surgical prep solutions containing iodine (Betadine, Povidone-iodine etc.)
• Do not apply patient plate where fluids may pool.
• Do not apply patient plate over injection site.
• Select a suitable site remote from any warming device.
• Do not place the patient plate under the patient. Weight bearing sites have restricted blood flow and may reduce the performance
of the patient plate.
• Do not place the patient plate across skin gaps such as the gap between the buttocks or gap between the arms and body.
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4. Plate Application
a
To reduce the risk of burns and pressure necroses:
• Inspect patient plate, cord, and cable. Do not use if cut, modified, or damaged.
• Remove clear liner from patient plate before applying to patient.
• Apply patient plate onto skin with long edge toward surgical site.
• Apply one end of patient plate and smoothly press to other end. Avoid air entrapment.
• Smooth down the patient plate edges after application to ensure complete patient plate adherence.
• Avoid stretching or folding either patient plate or patient's skin.
• Do not use electrode gel.
• Do not wrap patient plate completely around a limb. Do not overlap patient plate edges.
• Do not place the patient plate over compromised skin.
• Do not reposition patient plate after initial application. If patient is repositioned, confirm full plate-to-skin contact and integrity of all connections.
• Do not place compression stocking or device over patient plate.
• Do not coil or wrap cord or cable around patient's limb or metal object.
• Do not allow cord or cable to lie on or under patient.
• Do not place cable clamp under patient.
• Use ECG cables with RF suppressors/chokes to prevent electrosurgical current from flowing through the ECG electrodes. Any ECG electrodes
should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended.
Use of two patient plates with Y-adapter:
• Patients with dry skin, adipose tissue, and/or poor vascularization may generate a high impedance alarm and may require two
patient plates.
• Do not plug cords into Y-adapter until after each patient plate has been applied.
• Preferred placement of each plate is bilaterally (i.e., left and right side) equally distant from surgical site.
• For information about Y-adapters in Europe, please contact your local 3M representative. In the US and other countries outside of
Europe, use the 3M™ 1157-C Y-adapter.
5. Plate removal
• Do not remove by pulling on cable or cord.
• Start at corner. Peel back slowly at 180-degree angle to prevent skin trauma.
Notice to manufacturers and users of radio frequency (RF) medical devices and active accessories:
All 3M™ patient plates conform to Section 201.15.101.5 of the ANSI/AAMI/IEC 60601-2-2:2009 and ANSI/AAMI/IEC 60601-2-2:2017 Standards
which specifies that a patient plate must be capable of carrying a current of 700 milliamperes (500 milliamperes for pediatric patient plates) for
a continuous period of 60 seconds. Manufacturers of RF medical devices or accessories should not recommend 3M™ patient plates for use with
RF medical devices or accessories that can deliver a current load to the patient plate that exceeds the ANSI/AAMI/IEC 60601-2-2:2009 and ANSI/
AAMI/IEC 60601-2-2:2017 Standards. 3M™ certifies that the 3M™ 8100 Series and 1100 Series Split Style Electrosurgical Patient Plates, when
used in accordance with these Instructions for Use, meet the requirements of the ANSI/AAMI/IEC 60601-2-2:2009 and ANSI/AAMI/IEC 60601-2-
2:2017 standards for compatibility when used with high frequency (HF) electrosurgical generators with CQM systems that operate with both a
maximum impedance limit (not to exceed 150 ohms) and a differential (dynamic) impedance limit (not to exceed 40%).
For questions regarding compatibility of 3M™ 1100 Series and 8100 Series Electrosurgical Patient Plates with specific generators, in the
USA, please contact 3M at 1-800-228-3957. Outside the USA, please contact your 3M representative.
Shelf Life: For shelf life refer to the expiration date printed on each package.
Disposal: Dispose of contents/container in accordance with the local/regional/national/international regulations.
Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority.