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3M Health CareElectrosurgical Grounding Pad & Accessory Guide

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Electrosurgical Grounding Pad & Accessory Guide

Explanation of Symbols ...................................................................................................................................................... 4

Grounding Pad Instructions for Use .................................................................................................................................... 4

Frequently Asked Questions ............................................................................................................................................... 8

Competitive Grounding Pad Cross-Reference..................................................................................................................... 10

Solid Grounding Pad Generators ....................................................................................................................................... 12

Split Grounding Pad Generators ........................................................................................................................................ 16

3M Grounding Pads .......................................................................................................................................................... 17

Expiration and Shelf Life Information ................................................................................................................................ 21

3M Reusable Cables and Adapters ................................................................................................................................... 22

3M Adapter Kits ............................................................................................................................................................... 27

Grounding Pad Receptacles in Generators ....................................................................................................................... 29

Cable and Adapter Cleaning Information ........................................................................................................................... 31

Reusable Cable Instructions for Use .................................................................................................................................. 32

Adapter Instructions for Use ............................................................................................................................................. 35

3M Cable and Adapter Part Numbers ................................................................................................................................ 38

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Explanation of Symbols

Attention, see Instructions for Use.

The lot in a box and the hourglass are symbols that represent lot number and expiration date. The hourglass is followed by a year and month which represents the expiration date (year and month: 2010-10). The entire line after the hourglass represents the lot number (2010-10AZ).

Do not reuse.

Shock hazard warning.

Contains no natural rubber latex.

Instructions for Use - 3M™ Universal Electrosurgical Pads 9100 Series

Read and save this document. Make sure everyone who will use this product knows and understands all information contained within this document and AORN recommended practices for electrosurgery. READ WARNING.

Product Description 3M Universal Electrosurgical Pads (i.e. grounding pads, neutral electrodes) provide a safe return path for electrosurgical current. 3M Universal Pads consist of a conductive adhesive area surrounded by a non-conductive border adhesive. The Universal Pad backing is fluid resistant. Universal Pads are single use only, disposable and non sterile. Universal Pads are supplied pre-corded or non-corded.

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 Use1. Use Appropriate Pads, Equipment, and Accessories •DoestheelectrosurgicalgeneratorhaveaContact

Quality Monitoring System (e.g. REM™, ARM™, NESSY™)?

NO- use solid-style Universal Pads.

•UseECGcableswithRFsuppressors/chokestopreventelectrosurgicalcurrentfromflowingthroughtheECGelectrodes.

•Use3Mcablesandadaptersasrequiredwith3M Universal Pads.

•Checkexpirationdateonpackage.3MUniversalPads are safe to use for 14 days after package is opened.

2. To Reduce the Risk of Burns, Do Not Overload the Universal Pad with Too Much Current •Donotactivatetheelectrosurgicaldeviceoractive

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.

•Anycombinationofhighpower,longactivationtime 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. - Use the lowest possible power setting. - Use short activation times. If long activation is

necessary, allow time between activations to allow the tissue under Universal Pad to cool.

- Use two split-style Universal Pads with the 1157C Y-adapter.

- If you do not receive the desired surgical effect, stop andverifythecorrectdistention/irrigationsolutionand 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: •Selectasmooth,well-vascularized,muscularareaclose

to surgical site that allows full Universal Pad-to-skin contact.

•Sitemustbeclean,dry,andfreeofhair.Removehairatapplication site.

YES- use split-style Universal Pads.

3M™ Universal Electrosurgical Pads9100 Series English

Read and save this document. Make sure everyone who will use thisproduct knows and understands all information contained within thisdocument and AORN recommended practices for electrosurgery.READ WARNING

Explanation of Symbols:

• Attention, see instructions for use.

• The lot in a box and the hourglass are symbols that representlot number and expiration date. The hourglass is followed bya year and month which represents the expiration date (yearand month: 2010-10). The entire line after the hourglassrepresents the lot number 2010-10AZ).

• Do not reuse.

• Shock hazard warning.

• Contains no natural rubber latex.

Product Description3M Universal Electrosurgical Pads (i.e. grounding pads, neutral electrodes) providea safe return path for electrosurgical current. 3M Universal Pads consist of aconductive adhesive area surrounded by a nonconductive border adhesive. TheUniversal Pad backing is fluid resistant. Universal Pads are single use only,disposable and not sterile. Universal Pads are supplied pre-corded or non-corded.Universal Pads are compatible with electrosurgical generators (ESUs) used insurgical procedures defined by the ANSI/AAMI Standard HF-18:2001,Electrosurgical devices, Electrosurgical Devices (AAMI HF-18).

WARNINGImproper use of Universal Electrosurgical Pads can cause electrosurgicalburns or pressure necroses. For patient safety, follow all of the instructionsbelow. Failure to follow any of these instructions increases the risk ofelectrosurgical burns or pressure necroses.

Instructions for Safe Use1. Use Appropriate Pads, Equipment, and Accessories

• Does the electrosurgical generator have a Contact Quality MonitoringSystem (e.g. REM™, ARM™, NESSY™)?

o If NO - use solid-style Universal Pads.

o If YES - use split-styleUniversal Pads.

• Use ECG cables with RF suppressors/chokes to prevent electrosurgicalcurrent from flowing through the ECG electrodes.

• 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.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 theUniversal Pad with current and may result in a patient burn.

• Any combination of high power, long activation time, and a conductiveirrigant (e.g., saline) may overload the Universal Pad with current andmay result in a patient burn. To reduce this risk:

o Use non-conductive solutions unless specific medical reasons indicate otherwise.

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 Universal Pad to cool.

o Use two split-style Universal Pads with the 1157C Y-adapter.o If you do not receive the desired surgical effect, stop and verify the

correct distention/irrigation solution and good Universal Pad contactbefore proceeding with electrosurgery or increasing the powersetting.

3. Select an Appropriate SiteTo 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.• 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 electronic devices, contactdevice manufacturer for precautions to avoid interference.

• 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.

4. Pad ApplicationTo reduce the risk of burns and pressure necroses:• Inspect Universal Pad, cord, and cable. Do not use if cut, modified, or

damaged.• 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.• Do not use electrode gel.• Do not wrap Universal Pad completely around a limb. Do not overlap.• Do not reposition Universal Pad after initial application. If patient is

repositioned, confirm full pad-to-skin contact and integrity of allconnections.

• Do not place compression stocking or device over Universal Pad.• Do not coil or wrap cord or cable around limb or metal object.• Do not allow cord or cable to lie on or under patient.• Do not place cable clamp under patient.Use of two Universal Pads with 1157C Y-adapter:• Patients with dry skin, adipose tissue, and/or poor vascularization may

require two Universal Pads..• Do not plug cords into 1157C 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.

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.

For more information on electrosurgery, or to obtain a copy of the 3M High CurrentTechnical Bulletin (70-2009-8640-7), go to http://www.3M.com/groundingpad

Notice to manufacturers of radio frequency (RF) medical devices and activeaccessories: All 3M Universal Pads conform to Section 4.2.3.1 of the AAMI HF-18Standard, 2001 Edition, which specifies that a grounding pad must be capable ofcarrying a current of 700 milliamperes (mA) for a continuous period of 60 seconds.Manufacturers of RF medical devices or accessories should not recommend 3MUniversal Pads for use with RF medical devices or accessories that can deliver acurrent load to the Universal Pad that exceeds the AAMI HF-18 Standard.

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3Made in U.S.A. by 3M Health CareSt. Paul, MN. 55144-1000(USA) 1-800-228-3957www.3M.com

REM is a trademark of Valleylab.ARM is a trademark of Conmed/Aspen Labs.NESSY is a trademark of ERBE.©3M 2007 All rights reserved.3M is a trademark of 3M Co.






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•LocateUniversalPadclosertothesurgicalsitethan totheECGelectrodes.

•Removemetaljewelry. •Avoidplacementoverbonyprominences,metal

prostheses, or scar tissue. •Avoidplacementsuchthatcurrentflowsthrougha

metalprosthesisorconductiveimplant.Forpatients with implanted electronic devices, contact device manufacturer for precautions to avoid interference.

•DonotapplyUniversalPadwherefluidsmaypool. •DonotapplyUniversalPadoverinjectionsite. •Selectasuitablesiteremotefromanywarmingdevice.

4. Pad ApplicationTo reduce the risk of burns and pressure necroses: •InspectUniversalPad,cord,andcable.Donotuse

if cut, modified, or damaged. •ApplyoneendofUniversalPadandsmoothlypressto

other end. Avoid air entrapment. •AvoidstretchingorfoldingeitherUniversalPador

patient’s skin. •Donotuseelectrodegel. •DonotwrapUniversalPadcompletelyaroundalimb.

Do not overlap. •DonotrepositionUniversalPadafterinitialapplication.

If patient is repositioned, confirm full pad-to-skin contact and integrity of all connections.

•Donotplacecompressionstockingordeviceover Universal Pad.

•Donotcoilorwrapcordorcablearoundlimbormetal object.

•Donotallowcordorcabletolieonorunderpatient. •Donotplacecableclampunderpatient.Use of two Universal Pads with 1157C Y-adapter: •Patientswithdryskin,adiposetissueand/orpoor

vascularizationmayrequiretwoUniversalPads.

•Donotplugcordsinto1157CY-adapteruntilafter each Universal Pad has been applied.

•Preferredplacementofeachpadisbilaterally(i.e., leftandrightside)equallydistantfromsurgicalsite.

5. Pad removal•Donotremovebypullingoncableorcord.•Startatcorner.Peelbackslowlyat180degreeangletoprevent skin trauma.

Formoreinformationonelectrosurgery,obtainacopyofthe3MHighCurrentTechnicalBulletin(70-2009-8640-7).

Notice to manufacturers of radio frequency (RF)medical devices and active accessories: All 3M™ UniversalPadsconformtoSection201.15.101.5oftheANSI/AAMI/IEC60601-2-2:2009Standard,whichspecifiesthatagrounding pad must be capable of carrying a current of 700 milliamperes (mA) for a continuous period of 60 seconds. 3M™ certifies that the 3M™ 9100 Series Split Style Universal Electrosurgical Pads, when used in accordance with these InstructionsforUse,meettherequirementsoftheANSI/AAMI/IEC 60601-2-2:2009 standard for compatibility when used withhighfrequency(HF)electrosurgicalgeneratorswithCQMsystems that operate with both a maximum impedance limit (not to exceed 150 ohms) and a differential (dynamic) imped-ancelimit(nottoexceed40%).ManufacturersofRFmedicaldevices or accessories should not recommend 3M™ Universal PadsforusewithRFmedicaldevicesoraccessoriesthatcandeliver a current load to the Universal Pad that exceeds the ANSI/AAMI/IEC60601-2-2:2009Standard.






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Read and save this document. Make sure everyone whowill use this product knows and understands all informationcontained within this document and AORN recommendedpractices for electrosurgery. READ WARNING.

Product Description3M Electrosurgical Patient Plates (i.e. grounding pads,neutral electrodes) provide a safe return path forelectrosurgical current. Patient Plates consist of aconductive adhesive area surrounded by a non-conductiveborder adhesive. The patient plate backing is fluid resistant.Patient plates are single use only, disposable and non sterile.Patient plates are supplied pre-corded or non-corded.

The 3M™ 1146, 1148-LP, 1181 and 1182 Electrosurgical Patient Plates are designed for use on pediatric patients and should not be used on patients greater than 15kg (33 lbs).

WARNINGImproper use of Electrosurgical Patient Plates cancause electrosurgical burns or pressure necroses.For patient safety, follow all of the instructions below.Failure to follow any of these instructions increasesthe risk of electrosurgical burns or pressure necroses.

Instructions for Safe Use1. Use Appropriate Pads, Equipment, and Accessories •DoestheelectrosurgicalgeneratorhaveaContactQuality

Monitoring System (e.g. REM™, ARM™, NESSY™)?

NO- use solid-style patient plates.

•For patients 15kg or less use 3M™ 1146, 1148-LP, 1181 or 1182 Electrosurgical Patient Plates that are designed for use on pediatric patients.

•UseECGcableswithRFsuppressors/chokestopreventelectrosurgicalcurrentfromflowingthroughtheECGelectrodes.

•Use3Mcablesandadaptersasrequiredwith3Mpatientplates.

•Checkexpirationdateonpackage.3Mpatientplatesaresafe to use for 14 days after package is opened.

2. To Reduce the Risk of Burns, Do Not Overload thePatient Plate with Too Much Current •Donotactivatetheelectrosurgicaldeviceoractive

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.

•Anycombinationofhighpower,longactivationtime, 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:

- Use non-conductive solutions unless specific medical reasons indicate otherwise.

- 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 split-style patient plate with the 1157C Y-adapter.

- If you do not receive the desired surgical effect, stop andverifythecorrectdistention/irrigationsolutionand good patient plate contact before proceeding with electrosurgery or increasing the power setting.

3. Select an Appropriate SiteTo reduce the risk of burns and pressure necroses: •Selectasmooth,well-vascularized,muscularareaclose

to surgical site that allows full patient plate-to-skin contact.

•Sitemustbeclean,dry,andfreeofhair.Removehairatapplication site.

•LocatepatientplateclosertothesurgicalsitethantotheECGelectrodes.

•Removemetaljewelry. •Avoidplacementoverbonyprominences,metal

prostheses, or scar tissue. •Avoidplacementsuchthatcurrentflowsthroughametal

prosthesisorconductiveimplant.Forpatientswithim-planted electronic devices, contact device manufacturer for precautions to avoid interference.

•Donotapplypatientplatewherefluidsmaypool. •Donotapplypatientplateoverinjectionsite. •Selectasuitablesiteremotefromanywarmingdevice.

4. Plate ApplicationTo reduce the risk of burns and pressure necroses: •Usethelargestplatethatwillfit. •Inspectpatientplate,cord,andcable.Donotuseifcut,

modified, or damaged. •Applypatientplateontoskinwithlongedgetoward

surgical site. •Applyoneendofpatientplateandsmoothlypressto

other end. Avoid air entrapment. •Avoidstretchingorfoldingeitherpatientplateorpatient’s

skin.

YES- use split-style patient plates.

3M™ Electrosurgical Patient Plates1100 and 8100 Series English





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Product Description3M Electrosurgical Patient Plates (i.e. grounding pads, neutral electrodes) provide asafe return path for electrosurgical current. Patient Plates consist of a conductiveadhesive area surrounded by a nonconductive border adhesive. The patient platebacking is fluid resistant. Patient plates are single use only, disposable and notsterile. Patient plates are supplied pre-corded or non-corded. Patient plates arecompatible with electrosurgical generators (ESUs) used in surgical proceduresdefined by the ANSI/AAMI Standard HF-18:2001, Electrosurgical devices,Electrosurgical Devices (AAMI HF-18).

WARNINGImproper use of Electrosurgical Patient Plates can cause electrosurgicalburns or pressure necroses. For patient safety, follow all of the instructionsbelow. Failure to follow any of these instructions increases the risk ofelectrosurgical burns or pressure necroses.


• Does the electrosurgical generator have aContact Quality Monitoring System (e.g. REM™,ARM™, NESSY™)?

o If NO - use solid-style patient plates.o If YES - use split-style patient plates.


• 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.2. To Reduce the Risk of Burns, Do Not Overload the Patient Plate with Too


than 60 seconds in any 2-minute period, as this will overload the patientplate with current and may result in a patient burn.

• Any combination of high power, long activation time, and a conductiveirrigant (e.g., saline) may overload the patient plate with current and mayresult in a patient burn. To reduce this risk:


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 split-style patient plates with the 1157C 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.


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.• Avoid placement over bony prominences, metal prostheses, or scar tissue.• Avoid placement such that current flows through a metal prosthesis or


• 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.

4. Plate ApplicationTo reduce the risk of burns and pressure necroses:• Use the largest plate that will fit.• Inspect patient plate, cord, and cable. Do not use if cut, modified, or

damaged.• 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.• 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.• Do not reposition patient plate after initial application. If patient is

repositioned, confirm full plate-to-skin contact and integrity of allconnections.

• Do not place compression stocking or device over patient plate.• Do not coil or wrap cord or cable around limb or metal object.• Do not allow cord or cable to lie on or under patient.• Do not place cable clamp under patient.Use of two patient plates with 1157C Y-adapter:• Patients with dry skin, adipose tissue, and/or poor vascularization may

require two patient plates.• Do not plug cords into 1157C Y-adapter until after each patient plate has

been applied.• Preferred placement of each plate is bilaterally (i.e., left and right side)


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 of radio frequency (RF) medical devices and activeaccessories: All 3M patient plates conform to Section 4.2.3.1 of the AAMI HF-18Standard, 2001 Edition, which specifies that a patient plate must be capable ofcarrying a current of 700 milliamperes (mA) for a continuous period of 60 seconds.Manufacturers of RF medical devices or accessories should not recommend 3Mpatient plates for use with RF medical devices or accessories that can deliver acurrent load to the patient plate that exceeds the AAMI HF-18 Standard.

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Instructions for Use - 3M™ Electrosurgical Patient Plates 1100 and 8100 Series

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•Donotuseelectrodegel. •Donotwrappatientplatecompletelyaroundalimb.

Do not overlap. •Donotrepositionpatientplateafterinitialapplication.If

patient is repositioned, confirm full plate-to-skin contact and integrity of all connections.

•Donotplacecompressionstockingordeviceoverpatientplate.

•Donotcoilorwrapcordorcablearoundlimbormetalobject.

•Donotallowcordorcabletolieonorunderpatient. •Donotplacecableclampunderpatient.Use of two patient plates with 1157C Y-adapter: •Patientswithdryskin,adiposetissueand/orpoor

vascularizationmayrequiretwopatientplates. •Donotplugcordsinto1157CY-adapteruntilaftereach

patient plate has been applied. •Preferredplacementofeachplateisbilaterally(i.e.,left

andrightside)equallydistantfromsurgicalsite.

5. Plate removal •Donotremovebypullingoncableorcord. •Startatcorner.Peelbackslowlyat180degreeangleto

prevent skin trauma.

Formoreinformationonelectrosurgery,obtainacopyofthe3MHighCurrentTechnicalBulletin(70-2009-8640-7).

Notice to manufacturers of radio frequency (RF)medical devices and active accessories: All 3M™ patient platesconformtoSection201.15.101.5oftheANSI/AAMI/IEC60601-2-2:2009 Standard which specifies that a patient plate must be capable of carrying a current of 700 milliamperes (500 milliamperes for pediatric patient plates) for a continu-ousperiodof60seconds.3M™certifiesthatthe3M™8100Series and 1100 Series Electrosurgical Patient Plates, when used in accordance with these Instructions for Use, meet the requirementsoftheANSI/AAMI/IEC60601-2-2:2009standardforcompatibilitywhenusedwithhighfrequency(HF)electro-surgical 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%). ManufacturersofRFmedicaldevicesoraccessoriesshouldnotrecommend3M™patientplatesforusewithRFmedicaldevices or accessories that can deliver a current load to the patientplatethatexceedstheANSI/AAMI/IEC60601-2-2:2009Standard.






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Frequently Asked Questions

Generator and Grounding Pad CompatibilityQ: Can 3M Grounding Pads be used with ANY medical device that generates or uses radiofrequency (RF) current?

A:NO.3MGroundingpadsareintendedforusewithstandardelectrosurgical generators for the purposes of tissue cutting andcoagulationasdescribedintheANSI/AAMI/IEC60601-2-2:2009standard.3MGroundingPadshavenotbeenapprovedfor other medical uses such as cryogenic tissue freezing or painmanagementprocedures.IfthereisanyquestionaboutanRFmedicaldevice,themanufacturershouldbeaskedtocertifyin writing that their device is safe and efficacious for use with groundingpadsthatcomplywiththeANSI/AAMI/IEC60601-2-2:2009 standard.

Q: What does CQM stand for?

A: CQM is the abbreviation for Contact Quality Monitor, and is the generic term used for REM™, ARM™, NESSY™, all of which are trademarks of individual generator manufacturers.

Q. How does a CQM protect the patient against electrosurgical burns?

A: The CQM is designed to be used with split style grounding pads, and will not permit the generator to work if the grounding paddoesnothaveadequateelectricalcontactwiththepatient.

Q: Can you use a split style grounding pad on any generator?

A:No.ForoldergeneratorswhicharenotequippedwithaCQM, only solid style grounding pads can be used. If a split pad is mistakenly used, the generator will refuse to work.

Q: What happens if you try to use any brand of solid style pad (including 3M, Valleylab, Conmed, Aspen, and Megadyne) with a generator equipped with a CQM?

A: The generator will sense that a solid pad has been connect-ed to it, and will automatically deactivate the CQM circuit.

Q: What will happen if a grounding pad starts to come loose under the drapes during surgery?

A:Ifasplitstylepadisbeingusedwithageneratorequippedwith a CQM, an alarm will sound and the generator will be deactivated. If a solid pad is being used, there will be no alarm even if the pad becomes completely detached from the patient.

Q: In an O.R. with a mix of generators where some have CQM and some do not, would it be possible to standardize on a single brand of solid pad for the whole O.R.?

A:While this would be possible, this would deactivate the CQM in the generators, and result in a loss of 3M’s indemnification coverage. 3M strongly recommends that no type of solid grounding pad ever be used with a CQM generator.

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Clinical ConsiderationsQ: Should grounding pads be placed under warming blankets or warming devices?

A: No. The use of a warming blanket or warming device over a grounding pad elevates the skin temperature at the pad site and does not allow the heat from under the pad to escape properly. If it is not possible to keep the pad away from the warmingblanket/device,thenthewarmingblanket/deviceshould not be used at the same time as the electrosurgical generator.

Q: What conditions can make a grounding pad stick more aggressively to a patient, and possibly cause some delamination of the conductive adhesive from the pad upon removal?

A: Applying a grounding pad to a weight-bearing site will significantly increase its adhesion to the patient. In addition, perspiration from a patient will be absorbed by the conductive adhesive on the pad making it softer and stickier. Additional careandaveryslowremovaltechniqueshouldbeusedonanygrounding pad that is strongly adhered to the patient.

Q: Can you ETO sterilize a grounding pad?

A: The pad by itself may not be sterilized, but it may be left sealed in its original packaging and placed on the outside of a kit which will undergo ETO sterilization. This will sterilize the ex-terior of the package, but the pad will remain non-sterile. This sterilization must not compromise the integrity of the package. If the plate is exposed to ETO, residuals left in the adhesive or gel can cause a severe skin reaction.

Q: If a patient is only under local anesthetic for a surgical procedure, it is possible that they may feel some sensation of heat under the grounding pad?

A: Although uncommon, this is possible and perfectly normal. In the extremely unlikely circumstance that the sensation is so hot as to be uncomfortable, the grounding pad should be checked to make sure that it is still in full contact with the patient.

Grounding Pad Cables & AdaptersQ: What is the most common solid grounding pad adapter plug in the world?

A:Itisgenerallyknownasthe“1/4inchphonoplug”.The3M part numbers for this plug are 1151C for corded ground-ing pads and 3151C for non-corded pads. There are more old generators that use this plug style than all the other types combined.

Q: What is a Y-adapter, and when is it used?

A: A Y-adapter is used to connect two split style pads to an electrosurgical generator with a CQM. It is 3M part number 1157C. It is used when one split pad alone will not satisfy the CQM system on the generator due to high skin impedance or excessive adipose tissue on the patient.

Q: Does the red tab side of a 3M reusable grounding pad cable have to face a certain direction when attached to a 3M non-corded grounding pad?

A: No. The conductors inside the reusable cable will make contact with the pad either way.

Q: What is the 3M 1178C adapter used for?

A: It is used with CQM generators which may have small or worn connector pins in the grounding pad receptacle. It will make good electrical contact with the generator receptacle itself and then allow the split style pad to be plugged into the1178Cadapter.

Frequently Asked Questions

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Competitive Grounding Pad Cross-Reference

Notes on Competitive Grounding Pad Cross-Reference:

ThislistingrepresentsthemajorbrandssoldintheUnitedStates. There are a large number of independent and foreign brands that have been deliberately omitted from this list.

There are two reasons for this:

1. It is not possible to keep an up-to-date list of every brand of grounding pad sold in the world. Many different brandsareintroducedand/orbecomeobsoleteeveryyear.

2. Due to the fact that the CQM on generators (such as REMTM, ARMTM, NESSYTM, etc.) are deactivated when any type of solid style grounding pad is used with them, there are instances where the customer is using the wrong kind of grounding pad with their generator. This is a safety issue that cannot be solved by simple substitution of a 3M solid ground pad for another brand of solid pad.

Forthesereasons,thecorrectprocedureistofirst determine whether the generator is designed to be used with split or solid grounding pads and then to select the proper 3M grounding pad based on that information. A3Madapterwillberequiredifthegeneratorisonlydesigned to work with solid grounding pads.

NOTE 1:The3M1148-LP,1149C-LPand9135-LPgroundingpadsdonotrequiretheuseofthe3M1172Cadapter.

Grounding PadManufacturer

Grounding PadBrand Name Reference Number Recommended 3M Part # Alternate 3M Part #

Conmed Macrolyte® 400-2100 9135-LP 1149C-LP

Conmed Macrolyte® 400-2349 9130 1149

Conmed Macrolyte® 400-2700 9130F 1149F


Conmed Macrolyte® 402-2204-15 9165L




Conmed SureFit™ 410-2000 9165

Conmed SureFit™ 410-2100 9165L

Conmed SureFit™ 410-2200 9160F


Conmed Macrolyte® 425-2200 9135-LP 1148-LP


Conmed Macrolyte® 440-2400 No3Mequivalent


Conmed ThermoGard® 51-7310 9165 1179



Conmed ThermoGard® 51-7810 9135-LP 1149C-LP

Conmed ThermoGard® 51-7910 9135-LP 1148-LP



Valleylab Polyhesive™ II E7506 9135-LP 1149C-LP

Valleylab Polyhesive™ II E7507 9165 1179

Valleylab Polyhesive™ II E7507-DB 9165L


Valleylab Polyhesive™ II E7509B 9160F 1180F

Valleylab Polyhesive™ II E7510-25 9165 1181

Valleylab Polyhesive™ II E7510-25DB 9165L

Valleylab Polyhesive™ II E7512 No3Mequivalent

10

Grounding PadManufacturer

Grounding PadBrand Name Reference Number Recommended 3M Part # Alternate 3M Part #

Conmed Macrolyte® 400-2100 9135-LP 1149C-LP




Conmed Macrolyte® 402-2204-15 9165L





Conmed SureFit™ 410-2100 9165L

Conmed SureFit™ 410-2200 9160F


Conmed Macrolyte® 425-2200 9135-LP 1148-LP







Conmed ThermoGard® 51-7810 9135-LP 1149C-LP

Conmed ThermoGard® 51-7910 9135-LP 1148-LP



Valleylab Polyhesive™ II E7506 9135-LP 1149C-LP


Valleylab Polyhesive™ II E7507-DB 9165L


Valleylab Polyhesive™ II E7509B 9160F 1180F

Valleylab Polyhesive™ II E7510-25 9165 1181

Valleylab Polyhesive™ II E7510-25DB 9165L

Valleylab Polyhesive™ II E7512 No3Mequivalent

11

Listing for Electrosurgical Generatorswhich Use Solid Style Grounding Pads

Notes: Split style grounding pads cannot be used with these generators as they will usually keep the generator from producing surgical current.

GeneratorManufacturer Name

GeneratorModel Number

Non-Corded SolidPad Adapter

Non-Corded SolidPad Adapter Kit

3M 600 3153C 21153K

ACMI Acmitron C-650 3151C 21151K

ACMI Bicap 3151C 21151K

ACMI Bicap II (BC-200) 3151C 21151K

ACMI Pneumotome P-100 3153C 21153K

ACMI Pneumotome P-101 3153C 21153K

ACMI PneumotomeP-200A 3153C 21153K

ACMI Wrappler C-650 3151C 21151K

ACMI WrapplerC-650-FO 3151C 21151K

American Cytoscope Mfg. Inc - see ACMI

Aspen 100 3151C 21151K

Aspen 771 3151C 21151K

Aspen 772 3151C 21151K

Aspen 773 3151C 21151K

Aspen 3000 3151C 21151K

Aspen 9600 3151C 21151K

Aspen 9900 3151C 21151K

Aspen 2000-BP-11 3151C 21151KAspen 200-BP 3151C 21151K

Aspen 5000 Power Plus 3151C 21151K

Aspen 701-766 3151C 21151K

Aspen 737XL 3151C 21151K

Aspen 753E 3151C 21151K

Aspen Blendtomes 3153C 21153K

Aspen Hyfrecator 3151C 21151K

Aspen MF-180 3151C 21151K

Aspen MF-360 3151C 21151K

Aspen MF-360A 3151C 21151K

12





Aspen MF-450 3151C 21151K

Bard - see Aspen

Birtcher - see Aspen

Boston Medical INS 1000 3153C 21153K

Boston Medical Montgomery Nerve 3153C 21153K

Boston Scientific 820-T Use 21172 cable Use 21172 cable

Boston Scientific 821-T Use 21172 cable Use 21172 cable

Boston Scientific Enhart II 1172C Use 21172 cable Use 21172 cable

Bovie 400 3151C 21151K

Bovie 400B 3151C 21151K

Bovie 400SR 3151C 21151K

Bovie 405A 3153C 21153K

Bovie Bantam 3153C 21153K

Bovie BS 3151C 21151K

Bovie CSV 3151C 21151K

Bovie CSV II 3151C 21151K

Bovie RFG 3153C 21153K

Bovie RFG313 3153C 21153KBovie RFG313B 3153C 21153K

Bovie RFG3CF Use 21172 cable Use 21172 cable

Bovie Solid State 3151C 21151K

Bovie Specialist 3173C 21173K

Bovie URO 3151C 21151K

Bovie X10 3151C 21151K

Burdick SU-7 3151C 21151K

Burdick SU-8 3151C 21151K

Cameron-Miller 26-1290 3151C 21151K




Cameron-Miller 80-8086Mon-ItSentry 3153C 21153K

Listing for Electrosurgical Generators which Use Solid Style Grounding Pads (cont.)

13





CIRCON - see ACMI

Concept - see Aspen

Conmed - see Aspen

Cooper 1000 3151C 21151K

Cooper 6000 Use 21172 cable Use 21172 cable

Davol - see EMS

Electra - see EMS

Elmed-seeMartin/Elmed/Wolf

EMS Clinic 2000 3151C 21151K

EMS EMD 101-2000 3151C 21151K

EMS System 2000 3151C 21151K

EMS System 3000 3151C 21151K

EMS System 5000 3151C 21151K

EP Tech - see Boston Scientific

LNG Neuro-Gen901 3170C 21170K

Martin/Elmed/Wolf 56 3155C 21155K

Martin/Elmed/Wolf 2000 3171C 21171K

Martin/Elmed/Wolf 100L 3171C 21171KMartin/Elmed/Wolf 2040U 3155C 21155K

Martin/Elmed/Wolf 300B 3171C 21171KMartin/Elmed/Wolf 400RFS 3155C 21155K

Martin/Elmed/Wolf 600RF 3155C 21155K

Martin/Elmed/Wolf 600RFS 3155C 21155K

Martin/Elmed/Wolf Electrotome 120 3155C 21155K


Martin/Elmed/Wolf Electrotome170RF 3155C 21155K


Martin/Elmed/Wolf Electrotome600RF 3155C 21155K

Martin/Elmed/Wolf Elmed 150 3151C 21151K

Martin/Elmed/Wolf Laboratome569_A-120 3155C 21155K

Martin/Elmed/Wolf Teletome800RF 3155C 21155K


14





Maxxim Medical - see Bovie

MDT - see Bovie

Medtronic 8010 3153C 21153K

Medtronic ATAKRII 3153C 21153K

Microvasive Endostat 3151C 21151K

Microvasive Endostat II 3151C 21151K

NDM - see Aspen

Neomed/Richards 3000 Series 3151C 21151K

Olympus PSD & UES Models not available not available

Radionics - see BovieRichards-seeNeomed/Richards

Ritter - see BovieSiemens 3153C 21153K

Statham 3153C 21153K Sybron - see Bovie

Utah Medical 3151C 21151K

Utah Medical 3151C 21151K

Valleylab 3153C 21153K

Valleylab 3153C 21153K

Wolf-seeMartin/Elmed/Wolf


15

Listing for Electrosurgical Generatorswhich Use Split Style Grounding Pads

Notes: Split style grounding pads should always be used with these generators.While these generators will accept solid style pads, the use of any brand of solid pad (including 3M, Conmed, Valleylab, and Megadyne) will cause the CQM system (such as REM™, ARM™, NESSY™, and PSS™) to automatically turn itself off.



Non-Corded SplitPad Cable

Aaron Medical Systems Model 1250 21174

Aaron Medical Systems Model 2250 21174

Aspen Excalibur, all models 21174

Bard 4400 Power Plus 21174

Bard 4400 with Thermogard 21174

Bard 5000w/PSSupgrade 21174

Birtcher 4400 Power Plus 21174

Birtcher 4400 with Thermogard 21174

Birtcher 5000w/PSSupgrade 21174

Birtcher Argon Beam Systems 21174ABC

Bovie Medical Systems IDS-300 21174

Conmed Argon Beam Systems 21174ABC

Conmed Sabre, all models 21174

ERBE ICC, all models 21174

ERBE VIO, all models 21174

NDM Powerpoint 1000 21174Valleylab AllForcemodels 21174Valleylab Upgraded SSE models 21174Valleylab Upgraded Surgistats 21174

16

1146Small non-corded solid

grounding pad for use with a3M 21172 reusable cable and a

3M 31xxC series adapter plug

3M Electrosurgical Grounding Pads 1100 Series Small

The3M1146,1148-LP,1181and1182groundingpadsallhaveaconductorareaofapproximately10 squareinches,haveawhitefoambacking,andareintendedforusewhenalargerpadistoobigtouse at a recommended placement site.

1148-LP Small precorded solid

grounding pad for use with a3M 31xxC series adapter plug

1181Small precorded split

grounding pad

1182Small non-corded split

grounding pad for use with a3M 21174 reusable cable

17

1149 or 1149F 5-pack

Non-corded solid grounding pad for use with a 3M 21172

reusable cable and a 3M 31xxC series adapter plug

3M Electrosurgical Grounding Pads 1100 Series

The3M1149,1149C-LP,1179and1180groundingpadsallhaveaconductorareaofapproximately 20squareinchesandhaveawhitefoambacking.

1149C-LP Precorded solid grounding padfor use with a 3M 31xxC series

adapter plug

1179Precorded split grounding pad

1180 or 1180F 5-pack

Non-corded split grounding pad for use with a 3M 21174 reusable cable

18

8149F 5-pack

Non-corded solid grounding pad for use with a 3M 21172

reusable cable and a 3M 31xxC series adapter plug


The3M8149Fand8180Fgroundingpadsbothhaveaconductorareaofapproximately20squareinchesandfluid resistant non-woven backing which allows heat to pass through up to 25% faster than foam.

8180F 5-pack

Non-corded split grounding pad for use with a 3M 21174

reusable cable

19

9130 or 9130F 5-pack

Universal non-corded solid grounding pad for use with a 3M 21172 reusable cable and a 3M

31xxC series adapter plug


The3M9130,9135,9135-LP,9160and9165UniversalGroundingPadsallhaveaconductorareaof15squareinchesandcomewiththepatented3MGreenSafetyRingtechnologywhichallowsthemtoperformthesameasgrounding pads that are up to 33% larger in conductor area.In addition, they have fluid resistant, non-woven backing which allows heat to pass through up to 25% faster than foam and they have no minimum age or weight limit.

9135-LP Universal precorded solid

grounding pad for use with a 3M 31xxC series adapter plug

9160 or 9160F 5-pack

Universal non-corded split grounding pad for use with a 3M

21174 reusable cable

9165 Universal precorded split

grounding pad

20

Expiration and Shelf Life Information

3M Electrosurgical Pads are considered safe to use up to 14 days after package seal has been broken. Shelf life expiration date appears on each package. To the right of the hourglass (see illustration on package), we are now stating the year of expiration followed by the month of expiration in that year. The day of expiration will always bethelastdayofthatmonth.Ifforexample,“2012-10AT”weretoappeartotherightofthehourglass,yearofexpiration would be year 2012, month would be October and day would be the 31st.

“Lotnumber”willnowbecome“lotcode.”Thelotcodewillbemadeupoftwolettersthatwillfollowthenumbersforyearandmonth.Forexample,if“2012-10AT”weretoappeartotherightofthehourglass,thelotcodewouldbe:“AT.”ThesetwoletterswillvaryfromAAtoZZduringthemonth.

The new lot code will not state the date of manufacture. However, because our electrosurgical pads have a three-year shelf life, subtracting three-year shelf life from the expiration date will tell us the date of manufacture.

2012 - 10 AT

Expiration Year

ExpirationMonth

(Always last dayof the month.)

Date of Manufacture Subtract 3 Years from Expiration Year

(October, 2012 for our example.)

LotColor

21

3151CForusewith3Msolidstylegroundingpadsinconjunc-tion with a 3M 21172 reusable grounding pad cable.

Electrosurgical Generator Adaptersfor Solid Style Grounding Pads

Notes: All 3M 31xxC series adapters may be used with non-corded 3M solid style grounding pads and when usedinconjunctionwitha3M21172reusablecable.Thiscombinationofadapter,reusablecableandgroundingpad are for generators that use solid style grounding pads. These adapters may be used with corded 3M solid style grounding pads.

3153CForusewith3Msolidstylegroundingpadsinconjunc-tion with a 3M 21172 reusable grounding pad cable.

3MOrder#3151C-3MPart#70-2007-2685-2

3MOrder#3153C-3MPart#70-2007-2686-0

22

3154CForusewith3Msolidstyle

grounding pads in conjunctionwitha3M21172

reusable grounding pad cable.




3MOrder#3154C-3MPart#70-2007-2687-8

3MOrder#3155C-3MPart#70-2007-2688-6

3M Order #3171C - 3M Part # 70-2007-2690-2




23

1157C(also called a “Y” adapter)

Forusewithtwo3Msplitstylegrounding pads with preattached cords or for use with two 3M 21174 cables and non-corded 3M split style grounding pads.

Electrosurgical Generator Adaptersfor Split Style Grounding Pads

1178CForusewith3Msplitstylegrounding pad with preattached cord or for use with a 3M 21174 reusable cable and non-corded 3M split style grounding pad.

3MOrder#1157C-3MPart#70-2005-2302-8

3MOrder#1178C-3MPart#70-2007-0497-4

1178CL(5’ cable length)

Forusewith3Msplitstylegrounding pad with preattached cord or for use with a 3M 21174 reusable grounding pad cable when a 15’ long connection is needed.

3MOrder#1178C-3MPart#70-2007-1355-3

24

Reusable Cables for Use with Non-Corded3M Solid Style Grounding Pads

21172(10’ cable length)

Forusewith3M non-corded solid style

grounding pads.

3M Order #21172 - 3M Part # 70-2007-0191-3

21172L(15’ cable length)

Forusewith3M non-corded solid style

grounding pads.

3MOrder#21172L-3MPart#70-2007-0192-1

25

Reusable Cables for Use with Non-Corded3M Split Style Grounding Pads

21174(10’ cable length)

Forusewith3M non-corded split style grounding pads.

21174L(15’ cable length)


3M Order #21174 - 3M Part # 70-2007-0195-4

3MOrder#21174L-3MPart#70-2007-0196-2

21174ABC(10’ cable length)


3M Order #21174ABC - 3M Part # 70-2007-0197-0 26

Adapter Kits for use with Non-Corded 3M Solid Style Grounding Pads

Adapter kits are a combination of a 3M 3100 series adapter and a 3M 21172 reusable cable that are designed to be used with 3M non-corded solid style grounding pads. The sole purpose of these kits is to allow the customer to order a single product for use with their electrosurgical generator and 3M non-corded solid style grounding pads. Shown below is the 3M 21151K adapter kit which is the 3151C adapter and a 21172 reusable cable. Adapter kits are available for every type of 3M 3100 series adapter offered and in all cases the 3rd and 4th digit of the 3100 adapter will be identical to the 4th and 5th digit of the corresponding adapter kit.

21151K(10’ cable length)

Forusewith3Mnon-cordedsolidstyle grounding pads.

3MOrder#21151K-3MPart#70-2007-2778-5

3M 3151C adapter

+ 3M 21172 reusable cable

3M 21151K adapter kit

27



3MOrder#21153K-3MPart#70-2007-2780-1

3M 3153C adapter





3MOrder#21171K-3MPart#70-2007-2784-3

3M 3171C adapter



28

Common Electrosurgical GeneratorGrounding Pad Receptacles

Generator Receptacles Designed for Split Style Grounding Pads

The receptacle for split style grounding pads is almost an industry standard. This receptacle is rectangular in shapeandmeasures0.8inches(20mm)wideby0.4inches(10mm)high.Withinthisreceptaclearetwometalpins, symmetrically spaced, located 0.4 inches (10 mm) away from each other. In addition, there is a small, round hole located midway between these two metal pins.

In the case of Valleylab generators, the tip of a small micro-switch can be seen protruding into the area of the hole.With all other brands of generators, the hole is empty. Both the 3M split style grounding pads with a preattached cord and the 3M 21174 reusable grounding pad cable are designed to fit into these receptacles.

ValleylabGeneratorsAllOtherGeneratorBrands

Note: In areas outside of the United States, some newer brands of generators that are designed only for use with solid style grounding pads may have a receptacle similar to this. In all cases, however, there is one key difference betweenthissolidplatereceptacleandthetwoshownabove.Forgeneratorsthatusesolidplates,thereisnohole between the two metal pins. In this case, use the 3M 21172 reusable cable with a 3M non-corded, solid style grounding pad.

Generator Receptacles Designed for Solid Style Grounding Pads

The most common receptacle type in every country in the world for electrosurgical generators that use solid style grounding pads is the one that accepts the 3M 3151C adapter. This receptacle type is the one that was used in theoriginalBoviegeneratorssincethe1930’sandisknownas“thequarterinchphonojack”.Itisaroundholethat is .250 inches (6.35 mm) in diameter. A picture of this type of receptacle is shown below along with the plug that fits into it.

29

Generator Receptacles Designed for Solid Style Grounding Pads (cont.)

The second most common receptacle type for electrosurgical generators that use solid style grounding pads is theonethatacceptsthe3M3153Cadapter.Thisreceptacleisaroundholethatisapproximately5/32inches(4mm) in diameter. This receptacle is found on a wide variety of older European electrosurgical generators and also the Valleylab Surgistat generator. A picture of this type of receptacle is shown below along with the plug that fits into it.

Thereisamuchlesscommonreceptacletypethatisvisuallysimilartothe“quarterinchphonojack”exceptthatboth the receptacle and the plug that fit into it are smaller. This receptacle is a round hole that is .175 inches (4.45mm)indiameterandacceptsthe3M3173Cadapters.Thisreceptaclecanbeconfusedwiththelarger1/4inches (6.35 mm) receptacle due to the fact that the plugs that fit into both holes are similar in design. If a 3M 3151C is found to be too big to fit into the receptacle, then it is most likely designed for the 3173C adapter plug. A picture of this type of receptacle is shown below along with the plug that fits into it.

As mentioned above in the section on generator receptacles designed for split style grounding pads, there is a receptacle style that is similar except for the fact that there is no hole between the two metal pins. This recep-tacle can be found on some newer brands of electrosurgical generators that are sold outside of the United States and Europe. This receptacle has the same dimensions, but is designed to accept the 3M 21172 reusable cable for use with non-corded 3M solid style grounding pads. A picture of this type of receptacle is shown below along with the plug that fits into it.

30

Cable and Adapter Cleaning Information

Cleaning, Disinfection and Sterilization

Cables

•Cleanwithwarm,soapywaterandasoftbrushorsponge.

•Donotimmersetheentirecableincleaningsolution.

•Soniccleaningmaybeusedontheclamponly.

•Donotuseharshabrasivesorchemicalstocleanthecable.

•Reusablecablescanbesubjectedto3M™ Steri-Vac™ EO Sterilizer using a warm cycle (55°C), followed by a 16-hour mechanical aeration period at 55°C.

NOTE: 3M Reusable Cables have not been tested for other manufacturer’s EO sterilizers or EO sterilizer equipment.CAUTION:3Mmakesnoclaimsregardingtheefficacyoftheprocessasameansofinfection control. Consult your hospital’s Infection Control Officer or Epidemiologist.

•Donotsteamsterilizethecable.

•Becertainthecable/clampiscompletelydryaftercleaning.

Adapters

Cleaning the adapter is generally not needed, however, if it becomes contaminated, follow these instructions:


•Donotimmersetheadapterincleaningsolution.

•Donotuseharshabrasivesorchemicalstocleantheadapter.

•Donotsteamsterilizetheadapter.

•Becertaintheadapteriscompletelydryaftercleaning.

31

Reusable Cable Instructions for Use

3M™ Electrosurgical Reusable Cable

Read all safety information and instructions before using this product.


Attention, see Instructions for Use. Shock hazard warning.

Product Description:

The 3M Electrosurgical Reusable Cable is an accessory in an electrosurgical system. The cable uses plastic insulated conductive wire strands with a metallic connector that fits into the electrosurgical unit (ESU) and a clamping mechanism that securely connects to a 3M dispersive electrode (patient plate, grounding pad, Bovie pad,returnelectrode,etc.).ThesereusablecablesmeetAAMI/ANSIStandardsandRecommendedPractices, HF18-1993,forelectrosurgicalaccessories.

Indications for Use:

The 3M Electrosurgical Reusable Cable is designed to provide a safe pathway for the return of electrosurgical radiofrequency(RF)currentwhenusedwith3Mnon-cordeddispersiveelectrodes(returnelectrodes,patientplates, Bovie pads, grounding pads, etc.). These cables are only for use with 3M non-corded dispersive elec-trodes. The cables are adapted to work with most electrosurgical units (ESUs) where electrosurgery is utilized. Each cable has a specific ESU connector to match a variety of manufacturer’s ESU’s. Please consult a 3M ElectrosurgicalProductsrepresentativeifyouhavequestionsaboutthereusablecableforyourspecificESU.Useof this product for unintended applications could lead to an unsafe condition.

Precautions:

•Improperapplicationofuseofanyelectrosurgicalaccessory(reusablecable,adapterordispersiveelectrode)may result in electrosurgical shock or burn.

•Topreventelectricalshock,onlyplugESUconnectorsintoappropriateESUs.DonotallowtheESUcable connectortotouchanyearthgroundpotential(floor,groundedmetalobject,etc.).

•3Mmanufacturesthesecablestobeusedmultipletimes.Nocableisindestructible.Becauseitisan essential component, each cable should be carefully inspected monthly. Instructions for cable inspection and continuity testing are described in the Inspection Procedures section of this document.

•Donotuseiftheproducthasbeendamagedormodifiedinanymanner.

•Ifconcernedaboutthefunctionorqualityofanyelectrosurgicaldeviceoraccessory,replaceit.

•Donotusecableasatooltoremovethedispersiveelectrodefromthepatient.Ifutilizedinthisfashion,skin strippingorotherskininjuriescanoccur.

•TheContactQualityMonitoringSystem(CQMS,REM™, ARM™, NESSY™, etc.) will not function if the incorrect reusable cable is used. The type of ESU will determine which cable should be used.

32

Shock hazard warning!

Instructions for Use:

•Visuallyinspectcable,clampandconnectorfordamagepriortoeachuse.

•InspectconnectortoensurecorrectfitwiththeESUtobeused.

•Applyelectrosurgicaldispersiveelectrodetopatientfollowingthemanufacturer’sinstructions.

•Ensureclampleverisintheopen(up)position.Insertthetabofthedispersiveelectrode into slot on the clamp. See figure 1.

•Makecertaintheentiretabofthedispersiveelectrodeiscenteredintheclampand inserted up to the electrode backing material.

•Depresstheclampleverarmtothefullyclosed(down)position,flushwiththetopoftheclamp.Seefigure1.

•VerifythefunctionoftheESU’saudiblealarmcircuitbyturningontheESUbeforeattachingthecable.Analarmshouldsound.Ifnoalarmsounds,checkthealarmvolumeadjustment.Ifnotworkingproperly,returntheESUfor service.When the alarm sounds, insert the cable connector into the ESU dispersive electrode receiver and the alarm should cease. If it does not, try the procedure again. If the alarm does not stop after repeating the procedure, exchangetheESUand/orcableandtrythetestagain.

•Oncethecablecontinuityisestablished,checktheESU’sCQMSystemifapplicable.IftheCQMSystemalarmsatthis time or during surgery, carefully check dispersive electrode to patient contact, cable and clamp connections. Ifthealarmfaultisnotfound,replacethedispersiveelectrodeand/orcable.Ifthisdoesnotsatisfythealarmfault,replace the ESU.

•Attheconclusionofthesurgicalprocedure,removetheclampfromthedispersiveelectrode,thenremovethedispersive electrode from the patient.

•The cable is reusable.

Cleaning Procedure:


•Donotimmersetheentirecableincleaningsolution.

•Soniccleanersmaybeusedontheclamponly.


•Do not autoclave cable as it will melt.

•Becertainthecableclampiscompletelydryaftercleaning.

Figure 1

33

Inspection Procedures

Visual Inspection

1. Clean cable assembly as recommended to remove dirt, tape, patient skin preparation solution or body fluids.

2. Inspect cable insulation for nicks and cuts. Inspect clamp for plastic fractures and seam separation. Insure that the locking lever sits flush with the top of the clamp body when in the down position.

3.Holdtheclampandwiresothattheinsulationcanbeviewedattheclamp/wireinterfacewhilebending. See figure 2.

4. Bend and flex the cable side to side while viewing. If the insulation is cracked, this will be seen during maximum flexing of the cable at the outside radius. See figure 3. Discard the cable if the insulation is cracked or it fails visual inspection.

Electrical Inspection

Equipmentneededforthisinspectionisamulti-meterorvolt-ohmmeterwithextensionleadsandasmallpieceof metal (shim stock or a cut off tab from the end of a 3M split style dispersive electrode) to insert into the clamp endofareusablecable.Thefollowinginspectiontechniqueisbasedonelectricalcontinuityofindividualreusablecable wires.

1. Set the multi-meter or volt-ohm meter to measure resistance or continuity.

2. Insert a piece of shim stock or a cut split tab into each individual contact area of the clamp on the reusable cable assembly and close the clamp lever. Ensure that the shim stock pieces do not come into contact with each other.

3. Attach the meter leads to the shim stock and the corresponding plug pin of the cable connector. The lead should be securely attached to obtain a stable resistance measurement.

4.Measuretheresistanceofthecablewhileflexingthewireatthecable/connectorinterface.Ifthemeasuredresistance indicates discontinuity, the cable should be discarded and replaced with a new one. Repeat steps 3 and 4 to measure resistance for the second wire.

5. This inspection should be preformed monthly or as directed by hospital policy for similar electrosurgical devices.

6. Replace cables when electrical testing confirms discontinuity.

Figure 1 Figure 1

34

Adapter Cable Instructions for Use

3M™ Electrosurgical Adapters

Read all safety information and instructions before using this product.


Attention, see Instructions for Use. Shock hazard warning.

Product Description:

The 3M Electrosurgical Adapter is a reusable accessory in an electrosurgical system. The adapter consists of a metallic conductive connector designed to fit into the electrosurgical unit (ESU, generator, etc.) and a plastic insulated connector receptacle that receives a 3M corded dispersive electrode plug.

Indications for Use:

The 3M Electrosurgical Adapter is designed to provide a safe pathway for the return of electrosurgical radio frequency(RF)currentwhenusedwith3Mcordeddispersiveelectrode(returnelectrode,patientplate,Boviepad, grounding pad, etc.). These adapters are only for use with 3M corded dispersive electrodes. The adapters are designed to work with most electrosurgical units (ESUs) where electrosurgery is utilized. Each adapter has a specific ESU connector to match a variety of manufacturer’s ESU’s. Please consult a 3M Electrosurgical Products representativeifyouhavequestionsaboutanadapterforyourspecificESU.Useofthisproductforunintendedapplications could lead to an unsafe condition.

Precautions:

•Improperuseofanyelectrosurgicalaccessory(reusablecable,adapterordispersiveelectrode)mayresultinelectrosurgical shock or burn.

•Topreventelectricalshock,onlyplugESUadaptersintotheappropriateESU.DonotallowESUadaptertotouchanyearthgroundpotential(floor,groundedmetalobject,etc.).

•3Mmanufacturestheseadapterstobeusedmultipletimes.Noadapterisindestructible. Because it is an essential component, each adapter should be carefully inspected at intervals as directed by hospital policy for similar electrosurgical products. Instructions for adapter inspection and continuity testing are described in the Inspection Procedures section of this document.

•Donotuseiftheproducthasbeendamagedormodifiedinanymanner.

•Ifconcernedaboutthefunctionorqualityofanyelectrosurgicaldeviceoraccessory,replaceit.

35

Shock hazard warning!

Instructions for Use:

•Visuallyinspectadapterfordamagepriortoeachuse.

•InspectplugconnectortoensurecorrectfitwiththeESUtobeused.

•Applyelectrosurgicaldispersiveelectrodetopatientfollowingthemanufacturer’sinstructions.

•VerifythefunctionoftheESUaudiblealarmcircuitbyturningtheESUonbeforeattachingdispersiveelectrodetoadapter.Analarmshouldsound.Ifnoalarmsounds,checkthealarmvolumeadjustment.IfESUisnotwork-ing properly, return it for service. Once the alarm sounds, insert the dispersive electrode plug into adapter and the alarm should cease. If it does not, try the procedure again. If the alarm does not stop after repeating this procedure,exchangetheESUand/oradapterandtrythetestagain.

•Oncethecablecontinuityisestablished,checktheCQMSystemifasplitstyledispersiveelectrodeisused.Ifthe CQM System alarms at this time or during surgery, carefully check dispersive electrode to patient contact, cable and adapter connections and the active electrode. If the alarm fault is not found, replace the dispersive electrodeand/oradapterortheactiveelectrode.Ifthisdoesnotsatisfythealarmfault,replacetheESU.

•Attheconclusionofthesurgicalprocedure,removethedispersiveelectrodecordfromtheadapter,thenremove the dispersive electrode from the patient.

•The adapter is reusable.

Cleaning Procedure:

Cleaning the adapter is generally not needed, however if it becomes contaminated, follow these instructions:


•Donotimmersetheadapterincleaningsolution.


•Do not autoclave cable as it will melt.

•Becertaintheadapteriscompletelydryaftercleaning,beforenextuse.

36

Inspection Procedures

Visual Inspection

1. Clean adapter as recommended to remove dirt, tape, patient skin preparation solution or body fluids.

2. Inspect adapter for plastic fractures and seam separation.

3. Adapter should no longer be used when it fails visual inspection.

Electrical Inspection

Equipmentneededforthisinspectionisamulti-meterorvolt-ohmmeterwithextensionleads.Thefollowing inspectiontechniqueisbasedonelectricalcontinuityofindividualadapterleadwires.

1. Set the multi-meter or volt-ohm meter to measure resistance or continuity.

2. Attach the meter leads to the corresponding plug pin receiver. The lead should be securely attached to obtain a stable resistance measurement.

3. Measure the resistance of each adapter lead. If the measured resistance indicates discontinuity, the adapter should be discarded and replaced with a new one. Repeat steps 2 and 3 to measure resistance for the second lead.

4. This inspection should be preformed as directed by hospital policy for similar electrosurgical devices.

5. Replace adapter when electrical inspection confirms discontinuity.

37

3M Cable and Adapter Part Numbers

3100 Series Electrosurgical Generator Adapters for 3M Non-Corded Solid Style Grounding Pads (see page 22 for pictures)

3M Order Number 3M Stock Number

3151C 70-2007-2685-2

3153C 70-2007-2686-0

3154C 70-2007-2687-8

3155C 70-2007-2688-6

3171C 70-2007-2690-2

Electrosurgical Generator Adapters for 3M Split Style Grounding Pads (see page 24 for pictures)


1157C 70-2005-2302-8

1178C 70-2007-0497-4

1178CL 70-2007-1355-3

38

3M Cable and Adapter Part Numbers

Reusable Cables for Use with Non-Corded 3M Grounding Pads (see page 25 for pictures)


Solid Style

21172 70-2007-0191-3

21172L 70-2007-0192-1

Split Style

21174 70-2007-0195-4

21174L 70-2007-0196-2

21174ABC 70-2007-0197-0

Adapter Kits for Use with 3M Non-Corded Solid Style Grounding Pads (see page 27 for pictures)


21151K 70-2007-2778-5

21153K 70-2007-2780-1

21171K 70-2007-2784-3

39

Macrolyte and ThermoGard are registered trademarks of Conmed.SureFit is a trademark of Conmed.Polyhesive is a trademark of Covidien.REM is a trademark of Covidien.ARM is a trademark of Conmed/Aspen Labs.NESSY is a trademark of ERBE.3M is a trademark of 3M. Please recycle. Printed in U.S.A.© 3M 2005, 2007, 2012 All rights reserved.70-2009-7127-6

Infection Prevention Division3M Health Care3M Center, Building 275-4E-01St. Paul, MN 55144-1000U.S.A.1 800 228-3957www.3m.com/healthcare

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