3M 9130 Bedienungsanleitung Seite 2

3M™ Universal Electrosurgical Pads 9130, 9130F, 9160, 9160F, 9165E A
General Use
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contained within this document and AORN recommended practices for electrosurgery. READ WARNING
Intended Use
3M™ Universal Electrosurgical Pads (9130, 9130F, 9160, 9160F, 9165E) are designed to work with most electrosurgical units (ESU's)
for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid
Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split
style Universal Electrosurgical Pads are for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). The 3M™ Universal
Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained.
There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an
unsafe condition.
They are intended to be used by healthcare professionals in hospitals and surgical centers
Product Description
3M™ Universal Electrosurgical Pads (i.e. grounding pads, neutral electrodes) consist of a conductive adhesive area surrounded by a
nonconductive border adhesive. The pads are supplied pre-corded or non-corded, have fluid resistant non-woven backing, and have
a conductor area of 15in (97cm ). The pads are single use, disposable and non-sterile.
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WARNING
Improper use of Universal Electrosurgical Pads 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 Pads, Equipment, and Accessories
• Does the electrosurgical generator have a Contact Quality Monitoring System
(e.g. REM™, ARM™, NESSY™)?
If NO - use solid-style Universal Pads (9130/9130F).
–
– If YES - use split-style Universal Pads (9160/9160F/9165E).
• Use 3M™ cables and adapters as required with 3M™ Universal Pads.
• Check expiration date on package. 3M™ Universal Pads 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 Universal Pad 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 Universal Pad 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 Universal
Pad with current and may result in a patient burn. To reduce this risk:
– 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.
– Use the lowest possible power setting.
Use short activation times. If long activation is necessary, allow time between activations to allow the tissue under
–
patient plate to cool.
– Use two Universal Pads with a Y-adapter.
– If you do not receive the desired surgical effect, stop and verify the correct distention/irrigation solution and good
Universal Pad 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 Universal Pad-to-skin contact.
• Site must be clean, dry, and free of hair. Remove hair at application site.
• Locate Universal Pad 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 placement over surgical prep solutions containing iodine (Betadine, Povidone-iodine etc.)
• Do not apply Universal Pad where fluids may pool.
• Do not apply Universal Pad over injection site.
• Select a suitable site remote from any warming device.
• Do not place the Universal Pad under the patient. Weight bearing sites have restricted blood flow and may reduce the
performance of the Universal Pad.
• Do not place the Universal Pad across skin gaps such as the gap between the buttocks or gap between the arms and body.
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4. Pad Application
To reduce the risk of burns and pressure necroses:
• Inspect Universal Pad, cord, and cable. Do not use if cut, modified, or damaged.
• Remove clear liner from Universal Pad before applying to patient.
• Apply one end of Universal Pad and smoothly press to other end. Avoid air entrapment.
• Avoid stretching or folding either Universal Pad or patient's skin.
• Smooth down the Universal pad edges after application to ensure complete Universal Pad adherence.
• Do not use electrode gel.
• Do not wrap Universal Pad completely around a limb. Do not overlap the Universal Pad edges.
• Do not place the Universal Pad over compromised skin.
• Do not reposition Universal Pad after initial application. If patient is repositioned, confirm full pad-to-skin contact and integrity
of all connections.
• Do not place compression stocking or device over Universal Pad.
• 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 Universal Pads with Y-adapter:
• Patients with dry skin, adipose tissue, and/or poor
vascularization may generate a high impedance alarm and
may require two Universal Pads.
• Do not plug cords into Y-adapter until after each Universal Pad has been applied.
• Preferred placement of each pad is bilaterally (i.e., left and right side) equally distant
from surgical site.
• If the electrosurgical generator does not have a Contact Quality Monitoring System (e.g.
REM™, ARM™, NESSY™), then two solid pads may be used with the Y-adapter.
• 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. Pad 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™ Universal Electrosurgical Pads conform to Section 201.15.101.5 of the ANSI/AAMI/IEC 60601-2-2:2017 Standard, which
specifies that a grounding pad must be capable of carrying a current of 700 milliamperes (mA) for a continuous period of 60 seconds.
Manufacturers of RF medical devices or accessories should not recommend 3M™ Universal Electrosurgical Pads for use with RF
medical devices or accessories that can deliver a current load to the Universal Pad that exceeds these limits. 3M™ certifies that
the 3M™ 9100 Series Split Style Universal Electrosurgical Pads, when used in accordance with these Instructions for Use, meet the
requirements of the ANSI/AAMI/IEC 60601-2-2:2017 standard 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™ Universal Electrosurgical Pads 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.