3M Health Care Electrosurgical Grounding Pad & Accessory Guide Trusted Choices for Consistent Performance 2 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 3 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 • Use 3M cables and adapters as required with 3M will use this product knows and understands all information Universal Pads. 3. this Select an Appropriate SiteAORN recommended contained within document and • CSite heck expiration date on package. 3M Universal Pads 3. Select an Appropriate ™ surgical3M Pads Universal Electrosurgical To reduce the risk of burns andPads pressure necroses: To reduce the risk of burns and pressure necroses: practices for electrosurgery. READ WARNING. are safe to use for 14 days after package is opened. • Select a smooth, well-vascularized, muscular area close to •surgical Selectsite a smooth, well-vascularized, muscular area close to surgical site English 9100 Series English that allows full Universal Pad-to-skin contact. that allows full Universal Pad-to-skin contact. • Site must be clean, dry, and free of hair. Remove hair at application site.be clean, dry, and free of hair. Remove hair at application site. • Site must sure everyone who will useand thissave this document. Read Make sure everyone who will use this • Locate Universal Pad closer to the surgical site than to the •ECGLocate electrodes. Universal Pad closer to the surgical site than to the ECG electrodes. information containedproduct within this knows and understands all information contained within this • Remove metal jewelry. • Remove metal jewelry. practices for electrosurgery. document and AORN recommended practices for electrosurgery. • Avoid placement over bony prominences, metal prostheses,•orAvoid scar tissue. placement over bony prominences, metal prostheses, or scar tissue. READ WARNING • Avoid placement such that current flows through a metal prosthesis or • Avoid placement such that current flows through a metal prosthesis or Explanation of Symbols: conductive implant. For patients with implanted electronic devices, contact conductive implant. For patients with implanted electronic devices, contact s for use. manufacturer • Attention, see device instructions for use. for precautions to avoid interference. device manufacturer for precautions to avoid interference. • Do not apply Universal Pad where fluids may pool. • Do not apply Universal Pad where fluids may pool. 2010-10AZ hourglass are symbols that represent • The lot in a box and the hourglass are symbols that represent Do not apply Universal Pad over injection site. • Do not apply Universal Pad over injection site. n date. The hourglass is followed by lot number•and expiration date. The hourglass is followed by • Select a suitable site remote from any warming device. • Select a suitable site remote from any warming device. represents the expiration date (year a year and month which represents the expiration date (year 4. Pad Application 4. Pad Application e entire line after the hourglass and month: 2010-10). The entire line after the hourglass To reduce the risk of burns and pressure necroses: To reduce the risk of burns and pressure necroses: er 2010-10AZ). represents the lot number 2010-10AZ). • Inspect Universal Pad, cord, and cable. Do not use if cut, modified, or Universal Pad, cord, and cable. Do not use if cut, modified, or • Inspect 2 • Do not reuse. damaged. damaged. • Apply one end of Universal Pad and smoothly press to other• end. ApplyAvoid one air end of Universal Pad and smoothly press to other end. Avoid air • Shock hazard warning. entrapment. entrapment. er latex. • Contains no• natural rubber latex. Avoid stretching or folding either Universal Pad or patient’s •skin. Avoid stretching or folding either Universal Pad or patient’s skin. Product Description • Do not use electrode gel. • Do not use electrode gel. ng pads, neutral3M electrodes) provide Universal Electrosurgical Pads pads, neutral electrodes)around providea limb. Do not • (i.e. Do grounding not wrap Universal Pad completely • overlap. Do not wrap Universal Pad completely around a limb. Do not overlap. 3M Universal Pads consist of apath for electrosurgical a safe return 3M Universal PadsPad consist a application. If patient • Docurrent. not reposition Universal after of initial is reposition Universal Pad after initial application. If patient is • Do not nconductive border adhesive. The area surrounded conductive adhesive by a nonconductive border adhesive. The and integrity of all repositioned, confirm full pad-to-skin contact repositioned, confirm full pad-to-skin contact and integrity of all sal Pads are single use only, Universal Pad backing is fluid resistant. Universal Pads are single use only, connections. connections. supplied pre-corded or non-corded. disposable and not sterile. Universal Pads supplied pre-corded or non-corded. • Do not are place compression stocking or device over Universal• Pad. Do not place compression stocking or device over Universal Pad. gical generatorsUniversal (ESUs) used Padsin are compatible with electrosurgical generators used inlimb or metal object. • Do not coil or wrap cord or (ESUs) cable around • Do not coil or wrap cord or cable around limb or metal object. Standard HF-18:2001, surgical procedures defined by the Standard • ANSI/AAMI Do not allow cord or HF-18:2001, cable to lie on or under patient. • Do not allow cord or cable to lie on or under patient. s (AAMI HF-18).Electrosurgical devices, Electrosurgical Devices • Do not place(AAMI cable HF-18). clamp under patient. • Do not place cable clamp under patient. Use of two Universal Pads with 1157C Y-adapter: Use of two Universal Pads with 1157C Y-adapter: WARNING • Patients with skin, adipose tissue, and/or poor vascularization may with dry skin, adipose tissue, and/or poor vascularization may ads can causeImproper electrosurgical • Patients use of Universal Electrosurgical Padsdrycan cause electrosurgical require safety, two Universal ety, follow all of the instructions require two Universal Pads.. burns or pressure necroses. For patient follow Pads.. all of the instructions Do not plug cordsincreases into 1157Cthe Y-adapter Padplug has cords into 1157C Y-adapter until after each Universal Pad has ctions increases the risk of to follow any of •these • Do not below. Failure instructions risk of until after each Universal applied. . been applied. electrosurgical burns or pressurebeen necroses. • Preferred placement of each pad is bilaterally (i.e., left and •right side) placement of each pad is bilaterally (i.e., left and right side) Preferred Instructions for Safe Use equally distant from surgical site. equally distant from surgical site. Accessories 1. Use Appropriate Pads, Equipment, and Accessories ve a Contact Quality Monitoring • Does the electrosurgical generator have a Contact Quality Monitoring ™)? System (e.g. REM™, ARM™, NESSY™)? 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 Use 1. Use Appropriate Pads, Equipment, and Accessories • Does the electrosurgical generator have a Contact Quality Monitoring System (e.g. REM™, ARM™, NESSY™)? 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. - 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 and verify the correct distention/irrigation solution and good Universal Pad contact before proceeding with electrosurgery or increasing the power setting. YES- use split-style Universal Pads. Solid Style NO- use solid-style Universal Pads. Split Style Solid Style Split Style o If NO - use solid-style Universal Pads. o If YES - use split-style Universal Pads. chokes to prevent electrosurgical • Use ECG cables with RF suppressors/chokes to prevent electrosurgical 5. through Pad removal electrodes. 5. Pad removal current from flowing the ECG electrodes. • Doas notrequired removewith by pulling on cablePads. or cord. red with 3M Universal•Pads. • Do not remove by pulling on cable or cord. Use 3M cables and adapters 3M Universal Start at corner. Peel back slowly at 180 degree skinat corner. Peel back slowly at 180 degree angle to prevent skin M Universal Pads are •safe to use for • Start Check expiration date on• package. 3M Universal Pads are safe to use for angle to prevent trauma. trauma. 14 days after package is opened. verload the Universal withthe TooRisk of Burns, Do Not Overload the Universal Pad with Too 2. ToPad Reduce For more information on electrosurgery, or to obtain a copy of For the more 3M High Current on electrosurgery, or to obtain a copy of the 3M High Current information Much Current Bulletindevice (70-2009-8640-7), go to http://www.3M.com/groundingpad vice or active accessory for not more Technical Bulletin (70-2009-8640-7), go to http://www.3M.com/groundingpad • Do activate theTechnical electrosurgical or active accessory for more od, as this will overload than the 60 seconds in any 2-minute period, as this will overload the 4 manufacturers radio frequency (RF) medical devices and active esult in a patient burn. Universal Pad withNotice Notice to manufacturers of radio frequency (RF) medical devices and active currenttoand may result in of a patient burn. 3Mactivation Universal Pads to Section 4.2.3.1accessories: of the AAMI All HF-18 activation time, and• a Any conductive 3M Universal Pads conform to Section 4.2.3.1 of the AAMI HF-18 combination ofaccessories: high power,All long time,conform and a conductive Standard, 2001 Edition, which specifies that a grounding pad must be capable of e Universal Pad with current and Standard, 2001 Edition, which specifies that a grounding pad must be capable of • Use ECG cables with RF suppressors/chokes to prevent electrosurgical current from flowing through the ECG electrodes. 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. 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 nonconductive border adhesive. The Universal 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 in surgical procedures defined by the ANSI/AAMI Standard HF-18:2001, Electrosurgical devices, Electrosurgical Devices (AAMI HF-18). WARNING Solid Style • LocateImproper Universal closer to the surgical use of Pad Universal Electrosurgical Pads can site causethan electrosurgical orelectrodes. pressure necroses. For patient safety, follow all of the instructions to theburns ECG below. Failure to follow any of these instructions increases the risk of • Remove metal jewelry. electrosurgical burns or pressure necroses. for Safe • AvoidInstructions placement overUse bony prominences, metal 1. Use Appropriate Pads, Equipment, and Accessories prostheses, or scar tissue. generator have a Contact Quality Monitoring • Does the electrosurgical System (e.g. REM™, NESSY™)? • Avoid placement such thatARM™, current flows through a o If NO use solid-style metal prosthesis or conductive implant. For patients Universal Pads. with implanted devices, contact device o Ifelectronic YES - use split-style Universal Pads. manufacturer for precautions to avoid interference. • Use ECG cables with RF suppressors/chokes to prevent electrosurgical • Do not apply Universal Pad where fluids may pool. 5. Pad removal current from flowing through the ECG electrodes. • Do not remove by pulling on cable or cord. • UseUniversal 3M cables and adapters required with 3M Universal Pads. • Do not apply Pad overasinjection site. 5. Pad removal • Start at corner. Peel back slowly at 180 degree angle to prevent skin • Check expiration date on package. 3M Universal Pads are safe to use for • Select a suitable sitepackage remoteis opened. from any warming device. • Do not remove trauma. by pulling on cable or cord. 14 days after 2. To Reduce the Risk of Burns, Do Not Overload the Universal Pad with Too • Start at corner. Peel back slowly at 180 degree angle to For more information on electrosurgery, or to obtain a copy of the 3M High Current Much Current 4. Pad Application skinBulletin trauma. Technical (70-2009-8640-7), go to http://www.3M.com/groundingpad • Do not activate the electrosurgical device or active accessory for more prevent than 60 seconds in any 2-minute period, as this will overload the To reduce the risk of burns and pressure necroses: For more onofelectrosurgery, copyand active Noticeinformation to manufacturers radio frequency (RF)obtain medical adevices Universal Pad with current and may result in a patient burn. • Inspect Universal Pad, cord, Do nottime, useand a conductive accessories: All 3M Universal Pads conform to Section 4.2.3.1 of the AAMI HF-18 • Any combination of high and power,cable. long activation of the 3M High Current Technical Bulletin (70-2009-8640-7). Standard, 2001 Edition, which specifies that a grounding pad must be capable of irrigantor (e.g., saline) may overload the Universal Pad with current and if cut, modified, damaged. carrying a current of 700 milliamperes (mA) for a continuous period of 60 seconds. may result in a patient burn. To reduce this risk: • Apply one end of Universal Pad and smoothly press to Manufacturers of RF medical devices or accessories should not (RF) recommend 3M Notice to manufacturers of radio frequency o Use non-conductive solutions unless specific medical reasons Universal Pads for use with RF medical devices or accessories that can deliver a otherwise. other end. Avoidindicate air entrapment. medical devices and active accessories: All 3M™ current load to the Universal Pad that exceeds the AAMI HF-18 Standard. o Use the lowest possible power setting. • Avoid stretching folding either Padis or Universal Pads conform to Section 201.15.101.5 of the ANSI/ o Useorshort activation times.Universal If long activation necessary, patient’s skin. allow time between activations to allow the tissue under AAMI/IEC 60601-2-2:2009 Standard, which specifies that a Universal Pad to cool. • Do not use electrode gel. Universal Pads with the 1157C Y-adapter. o Use two split-style grounding pad must be capable of carrying a current of 700 If you do notPad receive the desired surgical effect, and verify the • Do not wrap oUniversal completely around a stop limb. milliamperes 3 (mA) for a continuous period of 60 seconds. correct distention/irrigation solution and good Universal Pad contact REM is a trademark of Valleylab. Do not overlap.before proceeding with electrosurgery or increasing the power 3M™Made certifies that in U.S.A. by the 3M™ 9100 Series Split Style Universal ARM is a trademark of Conmed/Aspen Labs. setting. 3M Health Care • Do not reposition Universal Pad after initial application. Electrosurgical Pads, when used in NESSY accordance with these is a trademark of ERBE. St. Paul, MN. 55144-1000 ©3M 2007 All rights reserved. (USA) 1-800-228-3957 If patient is repositioned, confirm full pad-to-skin contact Instructions for Use, meet the requirements of the ANSI/AAMI/ 3M is a trademark of 3M Co. www.3M.com and integrity of all connections. IEC 60601-2-2:2009 standard for compatibility when used • Do not place compression stocking or device over with high frequency (HF) electrosurgical generators with CQM Universal Pad. systems that operate with both a maximum impedance limit • Do not coil or wrap cord or cable around limb or metal (not to exceed 150 ohms) and a differential (dynamic) impedobject. ance limit (not to exceed 40%). Manufacturers of RF medical • Do not allow cord or cable to lie on or under patient. devices or accessories should not recommend 3M™ Universal • Do not place cable clamp under patient. Pads for use with RF medical devices or accessories that can Use of two Universal Pads with 1157C Y-adapter: deliver a current load to the Universal Pad that exceeds the • Patients with dry skin, adipose tissue and/or poor ANSI/AAMI/IEC 60601-2-2:2009 Standard. vascularization may require two Universal Pads. Split Style • 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 all connections. • 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: dry skin, tissue, and/or poor vascularization • Do •notPatients plugwith cords intoadipose 1157C Y-adapter until after may require two Universal Pads.. each Universal Pad has been applied. • 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., Preferred placement of each pad is bilaterally (i.e., left and right side) left•and right side) equally distant from surgical site. equally distant from surgical site. 5 Instructions for Use - 3M™ Electrosurgical Patient Plates 1100 and 8100 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. 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 Product Description burn. To reduce this risk: 3M Electrosurgical Patient Plates (i.e. grounding pads, 3. Select an Appropriate Site 3. Select an Appropriate Site - Use non-conductive solutions unless specific medical ™ Patient3M Plates Electrosurgical Patient Plates neutral electrodes) provide a safe return path necroses: for To reduce the risk of burns and pressure To reduce the risk of burns and pressure necroses: reasons otherwise. • Select a smooth, well-vascularized, muscular area close surgical site well-vascularized, • toSelect a smooth, muscularindicate area close to surgical site English 1100 electrosurgical and 8100 Series English current. Patient Plates consist of a that allows full patient plate-to-skin contact. that allows full patient plate-to-skin contact. Use the lowest possible power setting. • Site must besurrounded clean, dry,who and will free ofahair. site. • application Site must be clean, dry, and free of hair. Remove hair at application site. conductive adhesive area byuse non-conductive sure everyone who will usesave this this document. Read and Make sure everyone thisRemove hair at • Locate patient plate closer to the surgical site than to the ECG electrodes. • Locate patient plate closer to-the surgical site than to the ECG times. electrodes.If long activation is Use short activation information contained within this product knows and understands allpatient information contained withinis thisfluid resistant. border adhesive. plate backing •The Remove metal jewelry. • Remove metal jewelry. practices for electrosurgery. document and AORN recommended practices for electrosurgery. necessary, allow time between activations to allow • single Avoid placement over bony prominences,and metal non prostheses, or scar tissue. over bony prominences, metal prostheses, or scar •sterile. Avoid placement tissue. Patient use only, disposable READ WARNINGplates are • Avoid placement such that current flows through a metal prosthesis or • Avoid placement such that current flows through a metalpatient prosthesis plate or the tissue under to cool. ExplanationPatient of Symbols: plates are supplied pre-corded non-corded. conductive implant. For patientsor with implanted electronicconductive devices, contact implant. For patients with implanted electronic devices, contact U se two split-style patient plate with the 1157C s for use. device manufacturer for precautions to avoid interference.device manufacturer for precautions to avoid interference. • Attention, see instructions for use. The •3M™ 1146, 1181 Electrosurgical • 1148-LP, Do not apply patient plateand where1182 fluids may pool. • Do not apply patient plate where fluids may pool. 2010-10AZ hourglass are symbols that represent The lot in a box and the hourglass are symbols that represent Y-adapter. • Do designed not apply patientfor plateuse over injection site. • Do not apply patient plate over injection site. n date. The hourglass isPatient followed lot byPlates on pediatric patients number andare expiration date. The hourglass is followed by • Select a suitable site remote from any warming device. • Select a suitable site remote from any warming If you do notdevice. receive the desired surgical effect, stop represents the expiration date (year a year and month which represents the expiration date (year and should notPlate be Application used on patients greater than 15kg 4. 4. Plate Application e entire line after the hourglass and month: 2010-10). The entire line after the hourglass and verify the To reduce the risk of burns and pressure necroses: To reduce the risk of burns and pressure necroses: correct distention/irrigation solution er 2010-10AZ). represents the lot number 2010-10AZ). (33 lbs). • Use the largest plate that will fit. • Use the largest plate that will fit. and good patient plate contact before proceeding 2 • Do not reuse. • Inspect patient plate, cord, and cable. Do not use if cut,• modified, or Inspect patient plate, cord, and cable. Do not use if cut, modified, or with electrosurgery or increasing the power setting. damaged. damaged. • Shock hazard warning. • Apply patient plate onto skin with long edge toward surgical site.patient plate onto skin with long edge toward surgical site. • Apply WARNING er latex. • Contains no natural rubber latex. • Apply one end of patient plate and smoothly press to other end. one Avoid • Apply endairof patient plate and smoothly press to other end. Avoid air Improper use of entrapment. Electrosurgical Patient Plates canentrapment. 3. Select an Appropriate Site Product Description g pads, neutral electrodes) provide a Plates (i.e.•grounding 3M Electrosurgical Patient pads, neutral electrodes) provideplate a or patient’s Avoid stretching or folding either patient skin. stretching To • Avoid or folding either patient plate or skin. reduce the risk ofpatient’s burns and pressure necroses: electrosurgical burns or pressure necroses. tient Plates safe consist of acause conductive return path for electrosurgical current. Patient Plates consist • Do not use electrode gel. of a conductive • Do not use electrode gel. plate • Scompletely elect a around smooth, muscular area close border adhesive. Thearea patient plate by a safety, adhesive surrounded nonconductive border adhesive. patient plate • Do not wrap patient plateThe completely around a limb. below. Do • not Do overlap. not wrap patient a limb.well-vascularized, Do not overlap. For patient follow all of the instructions gle use only, disposable and not backing is fluid resistant. Patient plates arenot single use only, disposable and not • Do reposition patient plate after initial application. •If patient Do not isreposition patient plate after initial site application. Ifallows patient isfull patient plate-to-skin to surgical that Failure follow anyorofnon-corded. these instructions increases or non-corded. Patient plates are areto sterile. Patient plates supplied pre-corded Patient plates arecontact repositioned, confirm full plate-to-skin and integrity of all repositioned, confirm full plate-to-skin contact and integrity of all Us) used incompatible surgical procedures contact. with electrosurgical generators (ESUs) used inburns surgical procedures connections. connections. the risk of electrosurgical or pressure necroses. 1, Electrosurgical defineddevices, by the ANSI/AAMI Standard HF-18:2001, Electrosurgical • Do not place compressiondevices, stocking or device over patient plate. • Do not place compression stocking or device over patient plate. • Site must be clean, dry, and free of hair. Remove hair at Electrosurgical Devices (AAMI HF-18).• Do not coil or wrap cord or cable around limb or metal•object. 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 allow cord or cableapplication to lie on or under patient. site. WARNING • Do Plates not place clamp under patient. • Do not place cable clamp under patient. tes can cause electrosurgical Improper use of Electrosurgical Patient cancable cause electrosurgical • L ocate patient Use for ofsafety, two patient 1157C Y-adapter: Instructions Safe Use of two patient plates with 1157C Y-adapter:plate closer to the surgical site than to the ety, follow burns all of the instructions or pressure necroses. For patient followplates all Use of with the instructions • instructions Patients with increases dry skin, adipose • Patients may with dry skin, adipose and/or poor vascularization may ctions increases risk of below.the Failure to follow any of these the risktissue, of and/or poor vascularization ECGtissue, electrodes. require two patient plates. require two patient plates. . electrosurgical burnsAppropriate or pressure necroses. 1. Use Pads, Equipment, and Accessories • Remove jewelry. • Do not plug cords into 1157C Y-adapter until after each• patient Do notplate plughas cords into 1157C Y-adaptermetal until after each patient plate has Instructions for Safe Use • D oes the electrosurgical generator have a Contact Quality been applied. been applied. Accessories 1. Use Appropriate Pads, Equipment, and Accessories • A void placement over bony prominences, metal •System Preferred placement of each plate is bilaterally (i.e., left• and right side) Preferred placement of each plate is bilaterally (i.e., left and right side) Monitoring ve a • Does the electrosurgical generator have a(e.g. REM™, ARM™, NESSY™)? equally distant from surgical site. prostheses, or scar tissue. equally distant from surgical site. g. REM™, Contact Quality Monitoring System (e.g. REM™, ARM™, NESSY™)? • A void placement such that current flows through a metal NO- use solid-style YES- use split-style ates. o If NO - use solid-style patient plates. prosthesis or conductive implant. For patients with imlates. o If YES - use split-style patient plates. patient plates. patient plates. planted electronic devices, contact device manufacturer chokes to prevent•electrosurgical Use ECG cables with RF suppressors/chokes to prevent electrosurgical • For patients 15kg or less use 3M™ 1146, electrodes. for precautions to avoid interference. current from flowing through the ECG electrodes. ed with 3M patient • plates. Use 3M cables and adapters1181 as required 3M patient plates. 1148-LP, or with 1182 Electrosurgical Patient • Do not apply patient plate where fluids may pool. M patient plates are safe toexpiration use for date on package. 3M patient plates are safe to use for • Check 5. Plate removal 5. Plate removal are designed for use on pediatric 14 days afterPlates package isthat opened. • Do not apply patient plate over injection site. • Do not remove by pulling on cable or cord. • Do not remove by pulling on cable or cord. verload the2.Patient Plate with Too To Reduce the patients. Risk of Burns, Do Not Overload the Patient Plate with Too • Start at corner. Peel back slowly at 180 degree angle to• prevent skin Start at corner. Peel back slowly at 180 degree angle to prevent skin from any warming device. • Select a suitable site remote Much Current trauma. trauma. vice or active accessory for activate more • Do not the electrosurgical device or active accessory for more • Use ECG cables with RF suppressors/chokes to prevent od, as this will overload thanthe 60 patient seconds in any 2-minute period, as this will overload the patient Plate Application For more information on from electrosurgery, or tothrough obtain a copy the 3M High Current Forofmore information on 4. electrosurgery, or to obtain a copy of the 3M High Current electrosurgical flowing the ECG patient burn. plate with current and may result incurrent a patient burn. Technical Bulletin (70-2009-8640-7), go to http://www.3M.com/groundingpad Technical Bulletin (70-2009-8640-7), go tothe http://www.3M.com/groundingpad activation time, and conductive • aAny combination of high power, long activation time, and a conductive To reduce risk of burns and pressure necroses: electrodes. patient plate with current may irrigantand (e.g., saline) may overload the patient plate with current and may Notice to manufacturers of radio frequency (RF) medical devices and active of radio • Use the largest plate thatandwill fit. to manufacturers frequency (RF) medical devices active s risk: result patient To reduce this risk:adapters as required withNotice in a• Use burn. 3Maccessories: cables and 3M patient All 3M patient plates conform to Section 4.2.3.1 of the AAMI HF-18 accessories: All 3M patient plates conform to Section 4.2.3.1 of the AAMI HF-18 less specific medical reasons o Use non-conductive solutions unless specific medical reasons • I nspect patient plate, cord, and Standard, 2001 Edition, which specifies that a patient plate must be2001 capable of which specifies that a patient plate must be capable of cable. Do not use if cut, Standard, Edition, indicateplates. otherwise. carrying a current of 700 milliamperes (mA) for a continuous perioda of 60 seconds. carrying current of 700 milliamperes (mA) for aor continuous period of 60 seconds. modified, damaged. etting. o Use• theClowest power setting. heckpossible expiration on package. 3M patient plates are Manufacturers ofdate RF medical devices or accessories should not recommend Manufacturers of RF3Mmedical devices or accessories should not recommend 3M g activation is necessary, allow timeactivation o Use short times. If long activation is necessary, allow time • A pply patient plate onto long edge toward plates14 for use withafter RF medical devices orisaccessories thatplates can deliver patient for usea with RF medical devices or accessories that can skin deliver with a safe to patient use for days package opened. tissue under patient platebetween to cool. activations to allow the tissue under patient plate to cool. current load to the patient plate that exceeds the AAMI HF-18 Standard. current load to the patient plate that exceeds the AAMI HF-18 Standard. with the 1157C Y-adapter. surgical site. o Use two split-style patient plates with the 1157C Y-adapter. surgical effect, stop and o Ifverify you the do not receive the desired surgical effect, stop and verify the 2. To Reduce the Risk of Burns, Do Not Overload the • Apply one end of patient plate and smoothly press to ion and good patient platecorrect contactdistention/irrigation solution and good patient plate contact rgery or increasing thePatient power before proceeding with electrosurgery or increasing the power Plate3 with Too Much Current other end. Avoid air entrapment. 3 setting. REM is a trademark of Valleylab. REM is a trademark Valleylab. either patient plate or patient’s • Do not activate the electrosurgical device or active • Avoid stretching oroffolding Made in U.S.A. by Made in U.S.A. by ARM is a trademark of Conmed/Aspen Labs. ARM is a trademark of Conmed/Aspen Labs. 3M Health Care 3M Health Care is a trademark of ERBE. accessory for more than 60 secondsNESSY in any 2-minute skin. NESSY is a trademark of ERBE. St. Paul, MN. 55144-1000 St. Paul, MN. 55144-1000 LOT 6 (USA) 1-800-228-3957 www.3M.com Solid Style Split Style Solid Style Split Style LATEX ©3M 2007 All rights reserved. (USA) 1-800-228-3957 3M is a trademark of 3M Co. www.3M.com ©3M 2007 All rights reserved. 3M is a trademark of 3M Co. lectrosurgery. Solid Style • 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, contact device manufacturer for precautions to avoid interference. • Do not apply patient plate where fluids may pool. ymbols that represent • Do not apply patient plate over injection site. rglass is followed by • Select a suitable site remote from any warming device. expiration date (year 4. Plate Application er the hourglass • Do not use electrode 5. Plate removal gel. To reduce the risk of burns and pressure necroses: • Do not remove by pulling on cable or cord. • Do not •wrap patient plate completely around a limb. Use the largest plate that will fit. Inspect patient plate, cord, and cable. Do not use if cut, modified, or• Start at corner. Peel back slowly at 180 degree angle to Do not •overlap. damaged.patient plate after initial application. If prevent skin trauma. • Do not reposition • Apply patient plate onto skin with long edge toward surgical site. patient •is Apply repositioned, confirm full plate-to-skin contact one end of patient plate and smoothly press to other end. Avoid air For more information on electrosurgery, obtain a copy and integrity of all connections. entrapment. electrodes) provide Avoidcompression stretching or folding eitherorpatient plate or patient’s a • Do not •place stocking device over patient skin.of the 3M High Current Technical Bulletin (70-2009-8640-7). sist of a conductive • Do not use electrode gel. plate. Notice to manufacturers of radio frequency (RF) e. The patient plate • Do not wrap patient plate completely around a limb. Do not overlap. • D o not coil or wrap cord or cable around limb or metal devices and active accessories: All 3M™ patient sposable and not • Do not reposition patient plate after initial application. If patientmedical is Patient plates are object. repositioned, confirm full plate-to-skin contact and integrity of plates conform to Section 201.15.101.5 of the ANSI/AAMI/IEC all gical procedures • Do not allow connections. cord or cable to lie on or under patient. 60601-2-2:2009 Standard which specifies that a patient plate al devices, Do not place compression stocking or device over patient plate. • Do not •place cable clamp under patient. must be capable of carrying a current of 700 milliamperes • Do not coil or wrap cord or cable around limb or metal object. Use of two patient plates with 1157C Y-adapter: (500 milliamperes for pediatric patient plates) for a continu• Do not allow cord or cable to lie on or under patient. • P atients with dry skin, adipose tissue and/or poor • Do not place cable clamp under patient. ous period of 60 seconds. 3M™ certifies that the 3M™ 8100 electrosurgical Use of two patient plates with 1157C Y-adapter: of the instructions vascularization may require two patient plates. Series and 1100 Series Electrosurgical Patient Plates, when Patients with dry skin, adipose tissue, and/or poor vascularization may s the risk of • Do not •plug cords into 1157C Y-adapter until after each used in accordance with these Instructions for Use, meet the require two patient plates. patient •plate has been applied. of the ANSI/AAMI/IEC 60601-2-2:2009 standard Do not plug cords into 1157C Y-adapter until after each patientrequirements plate has applied. of each plate is bilaterally (i.e., left • Preferred been placement for compatibility when used with high frequency (HF) electro• Preferred placement of each is bilaterally side) generators with CQM systems that operate with both and right side) equally distant fromplate surgical site. (i.e., left and right surgical equally distant from surgical site. nt electrosurgical ient plates. are safe to use for tient Plate with Too ccessory for more overload the patient and a conductive ith current and may edical reasons necessary, allow time atient plate to cool. C Y-adapter. stop and verify the atient plate contact sing the power 5. a maximum impedance limit (not to exceed 150 ohms) and a differential (dynamic) impedance limit (not to exceed 40%). 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 Standard. 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. For more information on electrosurgery, or to obtain a copy of the 3M High Current Technical Bulletin (70-2009-8640-7), go to http://www.3M.com/groundingpad Notice to manufacturers of radio frequency (RF) medical devices and active accessories: All 3M patient plates conform to Section 4.2.3.1 of the AAMI HF-18 Standard, 2001 Edition, which specifies that a patient plate 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 patient plates for use with RF medical devices or accessories that can deliver a current load to the patient plate that exceeds the AAMI HF-18 Standard. 3 Made in U.S.A. by 3M Health Care St. Paul, MN. 55144-1000 (USA) 1-800-228-3957 www.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. 7 Frequently Asked Questions Generator and Grounding Pad Compatibility Q: Can you use a split style grounding pad on any generator? Q: Can 3M Grounding Pads be used with ANY medical device that generates or uses radiofrequency (RF) current? A: No. For older generators which are not equipped with a CQM, only solid style grounding pads can be used. If a split pad is mistakenly used, the generator will refuse to work. A: NO. 3M Grounding pads are intended for use with standard electrosurgical generators for the purposes of tissue cutting and coagulation as described in the ANSI/AAMI/IEC 60601-22:2009 standard. 3M Grounding Pads have not been approved for other medical uses such as cryogenic tissue freezing or pain management procedures. If there is any question about an RF medical device, the manufacturer should be asked to certify in writing that their device is safe and efficacious for use with grounding pads that comply with the ANSI/AAMI/IEC 60601-22:2009 standard. 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? 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 pad does not have adequate electrical contact with the patient. 8 A: The generator will sense that a solid pad has been connected 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: If a split style pad is being used with a generator equipped with 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. Frequently Asked Questions Clinical Considerations Grounding Pad Cables & Adapters Q: Should grounding pads be placed under warming blankets or warming devices? Q: What is the most common solid grounding pad adapter plug in the world? 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 warming blanket/device, then the warming blanket/device should not be used at the same time as the electrosurgical generator. A: It is generally known as the “1/4 inch phono plug”. The 3M part numbers for this plug are 1151C for corded grounding 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 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: 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. 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 care and a very slow removal technique should be used on any grounding pad that is strongly adhered to the patient. Q: What is a Y-adapter, and when is it used? 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: Can you ETO sterilize a grounding pad? Q: What is the 3M 1178C adapter used for? 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 exterior 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. 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 the 1178C adapter. 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. 9 Competitive Grounding Pad Cross-Reference Notes on Competitive Grounding Pad Cross-Reference: Grounding Pad Manufacturer Grounding Pad Brand Name Conmed Macrolyte® Conmed Macrolyte® Conmed Macrolyte® There are two reasons for this: Conmed Macrolyte® 1. It is not possible to keep an up-to-date list of every brand of grounding pad sold in the world. Many different brands are introduced and/or become obsolete every year. Conmed Macrolyte® Conmed Macrolyte® Conmed Macrolyte® 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. Conmed Macrolyte® Conmed SureFit™ Conmed SureFit™ Conmed SureFit™ Conmed SureFit™ Conmed Macrolyte® For these reasons, the correct procedure is to first 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. A 3M adapter will be required if the generator is only designed to work with solid grounding pads. Conmed Macrolyte® Conmed Macrolyte® Conmed Macrolyte® Conmed ThermoGard® Conmed ThermoGard® NOTE 1: The 3M 1148-LP, 1149C-LP and 9135-LP grounding pads do not require the use of the 3M 1172C adapter. Conmed ThermoGard® Conmed ThermoGard® Conmed ThermoGard® Conmed ThermoGard® Conmed ThermoGard® Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II Valleylab Polyhesive™ II This listing represents the major brands sold in the United States. There are a large number of independent and foreign brands that have been deliberately omitted from this list. 10 Reference Number Recommended 3M Part # Alternate 3M Part # 400-2100 9135-LP 1149C-LP 400-2349 9130 1149 400-2700 9130F 1149F 402-2204 9165 1179 402-2204-15 9165L 402-2508 9165 1181 402-2750 9160 1180 402-2800 9160F 1180F 410-2000 9165 410-2100 9165L 410-2200 9160F 410-2400 9160 425-2200 9135-LP 1148-LP 425-2725 9130 1146 440-2400 No 3M equivalent 450-2300 No 3M equivalent 51-7310 9165 1179 51-7410 9160 1180 51-7710 9165 1181 51-7810 9135-LP 1149C-LP 51-7910 9135-LP 1148-LP 7-382 9165 1179 7-383 9165 1181 E7506 9135-LP 1149C-LP E7507 9165 1179 E7507-DB 9165L E7509 9160 1180 E7509B 9160F 1180F E7510-25 9165 1181 E7510-25DB 9165L E7512 No 3M equivalent 11 Listing for Electrosurgical Generators which 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. Generator Manufacturer Name Generator Model Number Non-Corded Solid Pad Adapter Non-Corded Solid Pad Adapter Kit 3M 600 3153C 21153K ACMI Acmitron C-650 3151C 3151C 3151C 3153C 3153C 3153C 3151C 3151C 21151K 21151K 21151K 21153K 21153K 21153K 21151K 21151K 3151C 3151C 3151C 3151C 3151C 3151C 3151C 3151C 21151K 21151K 21151K 21151K 21151K 21151K 21151K 21151K ACMI Bicap ACMI Bicap II (BC-200) ACMI Pneumotome P-100 ACMI Pneumotome P-101 ACMI PneumotomeP-200A ACMI Wrappler C-650 ACMI Wrappler C-650-FO American Cytoscope Mfg. Inc - see ACMI Aspen 100 Aspen 771 Aspen 772 Aspen 773 Aspen 3000 Aspen 9600 Aspen 9900 Aspen 2000-BP-11 12 Aspen 200-BP 3151C 21151K Aspen 5000 Power Plus 3151C 21151K Aspen 701-766 3151C 21151K Aspen 737XL 3151C 21151K Aspen 753E 3151C 21151K Aspen Aspen Aspen Aspen Aspen Blendtomes Hyfrecator MF-180 MF-360 MF-360A 3153C 3151C 3151C 3151C 3151C 21153K 21151K 21151K 21151K 21151K Listing for Electrosurgical Generators which Use Solid Style Grounding Pads (cont.) Generator Manufacturer Name Generator Model Number Non-Corded Solid Pad Adapter Non-Corded Solid Pad Adapter Kit Aspen MF-450 3151C 21151K Birtcher - see Aspen Boston Medical Boston Medical Boston Scientific Boston Scientific Boston Scientific Bovie Bovie Bovie Bovie Bovie Bovie Bovie Bovie Bovie Bovie INS 1000 Montgomery Nerve 820-T 821-T Enhart II 1172C 400 400B 400SR 405A Bantam BS CSV CSV II RFG RFG 313 3153C 3153C Use 21172 cable Use 21172 cable Use 21172 cable 3151C 3151C 3151C 3153C 3153C 3151C 3151C 3151C 3153C 3153C 21153K 21153K Use 21172 cable Use 21172 cable Use 21172 cable 21151K 21151K 21151K 21153K 21153K 21151K 21151K 21151K 21153K 21153K Bovie RFG 313B 3153C 21153K Bovie RFG 3CF Use 21172 cable Use 21172 cable Bovie Solid State 3151C 21151K Bovie Specialist 3173C 21173K Bovie URO 3151C 21151K 3151C 3151C 3151C 3151C 3153C 3153C 3153C 3153C 21151K 21151K 21151K 21151K 21153K 21153K 21153K 21153K Bard - see Aspen Bovie Burdick Burdick Cameron-Miller Cameron-Miller Cameron-Miller Cameron-Miller Cameron-Miller X10 SU-7 SU-8 26-1290 80-1983 80-8010 80-8060 80-8086 Mon-It Sentry 13 Listing for Electrosurgical Generators which Use Solid Style Grounding Pads (cont.) Generator Generator Manufacturer Name Model Number CIRCON - see ACMI Concept - see Aspen Conmed - see Aspen Cooper 1000 Cooper 6000 Davol - see EMS Electra - see EMS Elmed - see Martin/Elmed/Wolf EMS Clinic 2000 EMS EMD 101-2000 EMS System 2000 EMS System 3000 EMS System 5000 EP Tech - see Boston Scientific LNG Neuro-Gen 901 Martin/Elmed/Wolf 56 Martin/Elmed/Wolf 2000 Martin/Elmed/Wolf 100L 14 Non-Corded Solid Pad Adapter Non-Corded Solid Pad Adapter Kit 3151C Use 21172 cable 21151K Use 21172 cable 3151C 3151C 3151C 3151C 3151C 21151K 21151K 21151K 21151K 21151K 3170C 3155C 3171C 3171C 21170K 21155K 21171K 21171K Martin/Elmed/Wolf 2040U 3155C 21155K Martin/Elmed/Wolf 300B 3171C 21171K Martin/Elmed/Wolf 400RFS 3155C 21155K Martin/Elmed/Wolf 600RF 3155C 21155K Martin/Elmed/Wolf 600RFS 3155C 21155K Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Martin/Elmed/Wolf Electrotome 120 Electrotome 170 Electrotome 170RF Electrotome 60 Electrotome 600RF Elmed 150 Laboratome 569_A-120 Teletome 800RF 3155C 3155C 3155C 3155C 3155C 3151C 3155C 3155C 21155K 21155K 21155K 21155K 21155K 21151K 21155K 21155K Listing for Electrosurgical Generators which Use Solid Style Grounding Pads (cont.) Generator Generator Manufacturer Name Model Number Maxxim Medical - see Bovie MDT - see Bovie Medtronic 8010 Medtronic ATAKRII Microvasive Endostat Microvasive Endostat II NDM - see Aspen Neomed/Richards 3000 Series Olympus PSD & UES Models Radionics - see Bovie Non-Corded Solid Pad Adapter Non-Corded Solid Pad Adapter Kit 3153C 3153C 3151C 3151C 21153K 21153K 21151K 21151K 3151C not available not available Siemens 3153C 21153K Statham 3153C 21153K 3151C 3151C 3153C 21151K 21151K 3153C 21153K 21151K Richards - see Neomed/Richards Ritter - see Bovie Sybron - see Bovie Utah Medical Utah Medical Valleylab Valleylab Wolf - see Martin/Elmed/Wolf 21153K 15 Listing for Electrosurgical Generators which 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. 16 Generator Manufacturer Name Aaron Medical Systems Aaron Medical Systems Aspen Bard Bard Bard Birtcher Birtcher Birtcher Birtcher Bovie Medical Systems Conmed Conmed ERBE ERBE NDM Generator Model Number Model 1250 Model 2250 Excalibur, all models 4400 Power Plus 4400 with Thermogard 5000 w/PSS upgrade 4400 Power Plus 4400 with Thermogard 5000 w/PSS upgrade Argon Beam Systems IDS-300 Argon Beam Systems Sabre, all models ICC, all models VIO, all models Powerpoint 1000 Valleylab All Force models Valleylab Upgraded SSE models Valleylab Upgraded Surgistats Non-Corded Split Pad Cable 21174 21174 21174 21174 21174 21174 21174 21174 21174 21174ABC 21174 21174ABC 21174 21174 21174 21174 21174 21174 21174 3M Electrosurgical Grounding Pads 1100 Series Small The 3M 1146, 1148-LP, 1181 and 1182 grounding pads all have a conductor area of approximately 10 square inches, have a white foam backing, and are intended for use when a larger pad is too big to use at a recommended placement site. 1146 Small non-corded solid grounding pad for use with a 3M 21172 reusable cable and a 3M 31xxC series adapter plug 1181 Small precorded split grounding pad 1148-LP Small precorded solid grounding pad for use with a 3M 31xxC series adapter plug 1182 Small non-corded split grounding pad for use with a 3M 21174 reusable cable 17 3M Electrosurgical Grounding Pads 1100 Series The 3M 1149, 1149C-LP, 1179 and 1180 grounding pads all have a conductor area of approximately 20 square inches and have a white foam backing. 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 1179 Precorded split grounding pad 18 1149C-LP Precorded solid grounding pad for use with a 3M 31xxC series adapter plug 1180 or 1180F 5-pack Non-corded split grounding pad for use with a 3M 21174 reusable cable 3M Electrosurgical Grounding Pads 8100 Series The 3M 8149F and 8180F grounding pads both have a conductor area of approximately 20 square inches and fluid resistant non-woven backing which allows heat to pass through up to 25% faster than foam. 8149F 5-pack Non-corded solid grounding pad for use with a 3M 21172 reusable cable and a 3M 31xxC series adapter plug 8180F 5-pack Non-corded split grounding pad for use with a 3M 21174 reusable cable 19 3M Electrosurgical Grounding Pads 9100 Series The 3M 9130, 9135, 9135-LP, 9160 and 9165 Universal Grounding Pads all have a conductor area of 15 square inches and come with the patented 3M Green Safety Ring technology which allows them to perform the same as grounding 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. 9130 Universal precorded solid grounding pad for use with a 3M 31xxC series adapter plug 9160 9165 or 9160F 5-pack Universal non-corded split grounding pad for use with a 3M 21174 reusable cable 20 9135-LP 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 Universal precorded split grounding pad 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 be the last day of that month. If for example, “2012-10 AT” were to appear to the right of the hourglass, year of expiration would be year 2012, month would be October and day would be the 31st. “Lot number” will now become “lot code.” The lot code will be made up of two letters that will follow the numbers for year and month. For example, if “2012-10 AT” were to appear to the right of the hourglass, the lot code would be: “AT.” These two letters will vary from AA to ZZ during the month. The new lot code will not state the date of manufacture. However, because our electrosurgical pads have a threeyear shelf life, subtracting three-year shelf life from the expiration date will tell us the date of manufacture. Expiration Year Expiration Month (Always last day of the month.) Lot Color 2012 - 10 AT Date of Manufacture Subtract 3 Years from Expiration Year (October, 2012 for our example.) 21 Electrosurgical Generator Adapters for Solid Style Grounding Pads Notes: All 3M 31xxC series adapters may be used with non-corded 3M solid style grounding pads and when used in conjunction with a 3M 21172 reusable cable. This combination of adapter, reusable cable and grounding pad are for generators that use solid style grounding pads. These adapters may be used with corded 3M solid style grounding pads. 3151C For use with 3M solid style grounding pads in conjunction with a 3M 21172 reusable grounding pad cable. 3M Order #3151C - 3M Part # 70-2007-2685-2 3153C For use with 3M solid style grounding pads in conjunction with a 3M 21172 reusable grounding pad cable. 3M Order #3153C - 3M Part # 70-2007-2686-0 22 3154C For use with 3M solid style grounding pads in conjunction with a 3M 21172 reusable grounding pad cable. 3M Order #3154C - 3M Part # 70-2007-2687-8 3155C For use with 3M solid style grounding pads in conjunction with a 3M 21172 reusable grounding pad cable. 3M Order #3155C - 3M Part # 70-2007-2688-6 3171C For use with 3M solid style grounding pads in conjunction with a 3M 21172 reusable grounding pad cable. 3M Order #3171C - 3M Part # 70-2007-2690-2 23 Electrosurgical Generator Adapters for Split Style Grounding Pads 1157C (also called a “Y” adapter) For use with two 3M split style grounding pads with preattached cords or for use with two 3M 21174 cables and non-corded 3M split style grounding pads. 3M Order #1157C - 3M Part # 70-2005-2302-8 1178C For use with 3M split style grounding pad with preattached cord or for use with a 3M 21174 reusable cable and non-corded 3M split style grounding pad. 3M Order #1178C - 3M Part # 70-2007-0497-4 1178CL (5’ cable length) For use with 3M split style grounding pad with preattached cord or for use with a 3M 21174 reusable grounding pad cable when a 15’ long connection is needed. 3M Order #1178C - 3M Part # 70-2007-1355-3 24 Reusable Cables for Use with Non-Corded 3M Solid Style Grounding Pads 21172 (10’ cable length) For use with 3M non-corded solid style grounding pads. 3M Order #21172 - 3M Part # 70-2007-0191-3 21172L (15’ cable length) For use with 3M non-corded solid style grounding pads. 3M Order #21172L - 3M Part # 70-2007-0192-1 25 Reusable Cables for Use with Non-Corded 3M Split Style Grounding Pads 21174 (10’ cable length) For use with 3M non-corded split style grounding pads. 3M Order #21174 - 3M Part # 70-2007-0195-4 21174L (15’ cable length) For use with 3M non-corded split style grounding pads. 3M Order #21174L - 3M Part # 70-2007-0196-2 21174ABC (10’ cable length) For use with 3M non-corded split style grounding pads. 26 3M Order #21174ABC - 3M Part # 70-2007-0197-0 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. 3M 3151C adapter + 3M 21172 reusable cable 3M 21151K adapter kit 21151K (10’ cable length) For use with 3M non-corded solid style grounding pads. 3M Order #21151K - 3M Part # 70-2007-2778-5 27 28 3M 3153C adapter + 3M 21172 reusable cable 3M 3171C adapter + 3M 21172 reusable cable 3M 21153K adapter kit 3M 21171K adapter kit 3M Order #21153K - 3M Part # 70-2007-2780-1 3M Order #21171K - 3M Part # 70-2007-2784-3 21153K 21171K (10’ cable length) (10’ cable length) For use with 3M non-corded solid style grounding pads. For use with 3M non-corded solid style grounding pads. Common Electrosurgical Generator Grounding 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 shape and measures 0.8 inches (20 mm) wide by 0.4 inches (10 mm) high.Within this receptacle are two metal pins, 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. Valleylab Generators All Other Generator Brands 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 between this solid plate receptacle and the two shown above. For generators that use solid plates, there is no hole 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 the original Bovie generators since the 1930’s and is known as “the quarter inch phono jack”. It is a round hole that 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 the one that accepts the 3M 3153C adapter. This receptacle is a round hole that is approximately 5/32 inches (4 mm) 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. There is a much less common receptacle type that is visually similar to the “quarter inch phono jack” except that both the receptacle and the plug that fit into it are smaller. This receptacle is a round hole that is .175 inches (4.45 mm) in diameter and accepts the 3M 3173C adapters. This receptacle can be confused with the larger 1/4 inches (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 receptacle 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 • Clean with warm, soapy water and a soft brush or sponge. • Do not immerse the entire cable in cleaning solution. • Sonic cleaning may be used on the clamp only. • Do not use harsh abrasives or chemicals to clean the cable. • Reusable cables can be subjected to 3M™ 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: 3M makes no claims regarding the efficacy of the process as a means of infection control. Consult your hospital’s Infection Control Officer or Epidemiologist. • Do not steam sterilize the cable. • Be certain the cable/clamp is completely dry after cleaning. Adapters Cleaning the adapter is generally not needed, however, if it becomes contaminated, follow these instructions: • Clean with warm, soapy water and a soft brush or sponge. • Do not immerse the adapter in cleaning solution. • Do not use harsh abrasives or chemicals to clean the adapter. • Do not steam sterilize the adapter. • Be certain the adapter is completely dry after cleaning. 31 Reusable Cable Instructions for Use 3M™ Electrosurgical Reusable Cable Read all safety information and instructions before using this product. Explanation of Symbols: 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, return electrode, etc.). These reusable cables meet AAMI/ANSI Standards and Recommended Practices, HF 18-1993, for electrosurgical accessories. Indications for Use: The 3M Electrosurgical Reusable Cable is designed to provide a safe pathway for the return of electrosurgical radio frequency (RF) current when used with 3M non-corded dispersive electrodes (return electrodes, patient plates, Bovie pads, grounding pads, etc.). These cables are only for use with 3M non-corded dispersive electrodes. 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 Electrosurgical Products representative if you have questions about the reusable cable for your specific ESU. Use of this product for unintended applications could lead to an unsafe condition. Precautions: • Improper application of use of any electrosurgical accessory (reusable cable, adapter or dispersive electrode) may result in electrosurgical shock or burn. • To prevent electrical shock, only plug ESU connectors into appropriate ESUs. Do not allow the ESU cable connector to touch any earth ground potential (floor, grounded metal object, etc.). • 3M manufactures these cables to be used multiple times. No cable is indestructible. Because it is an 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. • Do not use if the product has been damaged or modified in any manner. • If concerned about the function or quality of any electrosurgical device or accessory, replace it. • Do not use cable as a tool to remove the dispersive electrode from the patient. If utilized in this fashion, skin stripping or other skin injuries can occur. • The Contact Quality Monitoring System (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: • Visually inspect cable, clamp and connector for damage prior to each use. • Inspect connector to ensure correct fit with the ESU to be used. • Apply electrosurgical dispersive electrode to patient following the manufacturer’s instructions. • Ensure clamp lever is in the open (up) position. Insert the tab of the dispersive electrode into slot on the clamp. See figure 1. Figure 1 • Make certain the entire tab of the dispersive electrode is centered in the clamp and inserted up to the electrode backing material. • Depress the clamp lever arm to the fully closed (down) position, flush with the top of the clamp. See figure 1. • Verify the function of the ESU’s audible alarm circuit by turning on the ESU before attaching the cable. An alarm should sound. If no alarm sounds, check the alarm volume adjustment. If not working properly, return the ESU for 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, exchange the ESU and/or cable and try the test again. • Once the cable continuity is established, check the ESU’s CQM System if applicable. If the CQM System alarms at this time or during surgery, carefully check dispersive electrode to patient contact, cable and clamp connections. If the alarm fault is not found, replace the dispersive electrode and/or cable. If this does not satisfy the alarm fault, replace the ESU. • At the conclusion of the surgical procedure, remove the clamp from the dispersive electrode, then remove the dispersive electrode from the patient. • The cable is reusable. Cleaning Procedure: • Clean with warm, soapy water and a soft brush or sponge. • Do not immerse the entire cable in cleaning solution. • Sonic cleaners may be used on the clamp only. • Do not use harsh abrasives or chemicals to clean the cable. • Do not autoclave cable as it will melt. • Be certain the cable clamp is completely dry after cleaning. 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. Hold the clamp and wire so that the insulation can be viewed at the clamp/wire interface while bending. See figure 2. 4. B end 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 Equipment needed for this inspection is a multi-meter or volt-ohm meter with extension leads and a small piece of metal (shim stock or a cut off tab from the end of a 3M split style dispersive electrode) to insert into the clamp end of a reusable cable. The following inspection technique is based on electrical continuity of individual reusable cable 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. A ttach 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. Measure the resistance of the cable while flexing the wire at the cable/connector interface. If the measured resistance 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. T his 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 34 Figure 1 Adapter Cable Instructions for Use 3M™ Electrosurgical Adapters Read all safety information and instructions before using this product. Explanation of Symbols: 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) current when used with 3M corded dispersive electrode (return electrode, patient plate, Bovie pad, 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 representative if you have questions about an adapter for your specific ESU. Use of this product for unintended applications could lead to an unsafe condition. Precautions: • Improper use of any electrosurgical accessory (reusable cable, adapter or dispersive electrode) may result in electrosurgical shock or burn. • To prevent electrical shock, only plug ESU adapters into the appropriate ESU. Do not allow ESU adapter to touch any earth ground potential (floor, grounded metal object, etc.). • 3M manufactures these adapters to be used multiple times. No adapter is indestructible. 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. • Do not use if the product has been damaged or modified in any manner. • If concerned about the function or quality of any electrosurgical device or accessory, replace it. 35 Shock hazard warning! Instructions for Use: • Visually inspect adapter for damage prior to each use. • Inspect plug connector to ensure correct fit with the ESU to be used. • Apply electrosurgical dispersive electrode to patient following the manufacturer’s instructions. • Verify the function of the ESU audible alarm circuit by turning the ESU on before attaching dispersive electrode to adapter. An alarm should sound. If no alarm sounds, check the alarm volume adjustment. If ESU is not working 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, exchange the ESU and/or adapter and try the test again. • Once the cable continuity is established, check the CQM System if a split style dispersive electrode is used. If the 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 electrode and/or adapter or the active electrode. If this does not satisfy the alarm fault, replace the ESU. • At the conclusion of the surgical procedure, remove the dispersive electrode cord from the adapter, then remove 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: • Clean with warm, soapy water and a soft brush or sponge. • Do not immerse the adapter in cleaning solution. • Do not use harsh abrasives or chemicals to clean the cable. • Do not autoclave cable as it will melt. • Be certain the adapter is completely dry after cleaning, before next use. 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 Equipment needed for this inspection is a multi-meter or volt-ohm meter with extension leads. The following inspection technique is based on electrical continuity of individual adapter lead wires. 1. Set the multi-meter or volt-ohm meter to measure resistance or continuity. 2. A ttach the meter leads to the corresponding plug pin receiver. The lead should be securely attached to obtain a stable resistance measurement. 3. M easure 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 3153C 3154C 3155C 3171C 70-2007-2685-2 70-2007-2686-0 70-2007-2687-8 70-2007-2688-6 70-2007-2690-2 Electrosurgical Generator Adapters for 3M Split Style Grounding Pads (see page 24 for pictures) 38 3M Order Number 3M Stock Number 1157C 1178C 1178CL 70-2005-2302-8 70-2007-0497-4 70-2007-1355-3 3M Cable and Adapter Part Numbers Reusable Cables for Use with Non-Corded 3M Grounding Pads (see page 25 for pictures) 3M Order Number Solid Style 21172 21172L Split Style 21174 21174L 21174ABC 3M Stock Number 70-2007-0191-3 70-2007-0192-1 70-2007-0195-4 70-2007-0196-2 70-2007-0197-0 Adapter Kits for Use with 3M Non-Corded Solid Style Grounding Pads (see page 27 for pictures) 3M Order Number 3M Stock Number 21151K 21153K 21171K 70-2007-2778-5 70-2007-2780-1 70-2007-2784-3 39 Infection Prevention Division 3M Health Care 3M Center, Building 275-4E-01 St. Paul, MN 55144-1000 U.S.A. 1 800 228-3957 www.3m.com/healthcare 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