AEM® Foot Control Suction-Irrigation Electrodes
Contents
1. Cord Shielded Shaft Sheath Tube Connection Assembly 2 Positions N a Oa g ia E pa Electrode Tip Adapter F e This product is supplied non sterile and must be sterilized prior to use CAUTION e This product is rated to 9000 Vp p Limit electrosurgical generator power setting to 60 Watts or lower Higher settings may result in spurious insulation failure alarms and or insulation breakdown See Encision AEM Monitor Operator Service Manual for list of compatible electrosurgical generators e This instrument has been validated for 10 typical cycles including cleaning sterilization and use The actual number of uses may vary depending on usage conditions Discard if any End of Life Indicators are present Use with Monopolar Electrosurgery AEM instruments in conjunction with an AEM Monitor properly connected to the electrosurgical generator ESU continuously monitor and dynamically manage stray energy insulation failure and capacitive coupling in zones 2 amp 3 which are likely out of the surgeon s field of view AEM shielding does not cover zone 1 which the surgeon should keep in view during instrument activation As in all applications misapplied electrosurgical energy remains the responsibility of the attending surgeon PEC Zone 1 Zone 2 Zone 3 Note Zone 1 equals approximately 1 5cm tip to shield Note Zone 3 equals area of Trocar Cannula Lapa2. Do not exceed temperatures of 135 C 275 F Performance to specification has not been verified above this temperature Damage to the product may occur Cold Soak Sterilization is not recommended Testing results reprocessing Product damage will result if the instrument and 7 Remove the components from the detergent solution indicate that cold soak sterilization Glutaraldehyde is not adapter are disassembled and rinse thoroughly under running distilled or adequate for this product Manufacturer s recommended cycle NOTE demineralized water minimum of 3 minutes times DO NOT always provide a 10 sterility assurance level 7 e Gas Plasma Hydrogen Peroxide Sterilization is not e The use of fully distilled or demineralized water is preferred for recommended for ENCISION Instruments Instruments with long cleaning and rinsing narrow lumens may pose a challenge for this type of sterilization Manual Cleaning Combination Manual Automated Cleaning rare NOTE Step Description Step Description n _ e Validation of sterilization cycles other than steam autoclave is the 1 Remove the Sheath Tube from the SIE instrument 1 Follow Manual Cleaning steps 1 7 resaonsibilityofithe end KA When using an ES3800 series Removable Adapter black 2 Use of a sonicator or ultrasonic cleaner at 35 45 kHz can P y i color the adapter may be removed from the instrument s
3. 3 0f 4 Product Life Express Warranty The life of this surgical instrument is largely dependent on the care and handling at the point of use cleaning sterilization For optimal instrument life protect it from contact impact with other instruments during decontamination and sterilization The number of uses may be reduced by improper handling and prevac or flash sterilization methods Use of coagulation settings over 60 watts or use of spray coagulation will tend to shorten product life Open circuit non tissue contact activation will shorten product life End of Life Indicators The ES3770 series electrodes may be used up to 10 uses or until an electrode exhibits any of the following end of life indicators whichever comes first Visually inspect and electrically test prior to use Discontinue use if any of the following are evident e Number of uses exceeds 10 e Intermittent electrical performance e Bent electrode shaft or tip affecting function of sheath or insertion into trocar e Any insulation damage which exposes metal AEM Shield along the length of the instrument s shaft and or any insulation damage in Zone 1 e Any damage to Sheath Tube Sheath Replacement Sheath may be replaced if End of Life indications are detected For replacement information please contact the Encision Service Center 303 444 2600 ENCISION hereby warrants to Buyer that products purchased hereunder shal
4. contacting tissue The second device will not be protected from capacitive coupling and insulation failure e Keep electrosurgical instruments away from the patient and operative field when not in use Accidental activation can result in unintended injury to the patient e See electrosurgical generator manual and AEM Monitor Operator Service Manual for precautions concerning the general application of electrosurgical equipment CAUTION e Any modification of the instrument including bending of the tip may cause permanent product damage such as breakage or reduce the life of the instrument e Damaged internal insulation of the cord and or instrument or loss of shield continuity may cause ESU return pad alarms triggered by the AEM Monitor s Fault Indicators For maximum patient safety discontinue use of the instrument if this occurs 01976 006 2012 04 1of4 Assembly Instructions ES3700 series Permanent Adapter amber color 1 Remove the amber colored clip from the SIE instrument To make removal of the clip easier cut the clip on one side Cut the Clip Remove the Clip 2 Insert and twist the adapter into the SIE instrument until there is no gap between the instrument and adapter Proper assembly of the adapter to instrument is accompanied by an audible click 1 Leave the amber colored clip in its original position on the SIE instrument 2 Insert and twist the adapter into the SIE instrum
5. AEM Suction Irrigation Electrodes and Adapters Instructions For Use Care Ry ony S ENCISION recommends placing this document with the instructions for use for your AEM Monitor Device Description Suction Irrigation Electrodes The ES3770 series Suction Irrigation Electrode SIE is a reusable instrument designed to fit commonly used 5 5mm trocar cannulas Various tip styles are available The ES3700 series and ES3800 series Adapters sold separately allow the SIE to connect to a variety of suction irrigation trumpet valves When using a Stryker trumpet valve an adapter is not required e The ES3700 series Permanent Adapter amber color is designed to be permanently attached to the SIE and once assembled to the instrument should not be removed Reprocess the instrument and adapter assembled together e The ES3800 series Removable Adapter black color may be removed from the SIE The instrument and adapter may be reprocessed disassembled or assembled Principle of Operation The ES3770 series Suction Irrigation Electrode combines AEM technology with suction and irrigation of fluids during laparoscopic electrosurgery The Sheath Tube is an integral part of the SIE and must be used at all times When the sheath is in the extended position it facilitates suction and irrigation When the sheath is retracted the electrode tip is exposed allowing application of energy to the electrode tip
6. adapter and pull away from the SIE instrument Reprocessing Instructions After use the instrument must be cleaned and sterilized before reuse This product has been validated for 10 sterility assurance level when reprocessed in accordance with these cleaning and sterilization instructions CAUTION e Treat a used instrument as a potential biohazard until cleaning and sterilization has been completed Microscopic residues may remain after cleaning e Stainless Steel is rust resistant not rust proof Instruments should be kept dry when not in use e Do not use bleach sodium hypochlorite based products during cleaning Bleach is extremely corrosive to metals and can negatively affect the electrosurgical instruments Refer to your cleaning products Material Safety Data Sheet MSDS to ensure that they are not corrosive or harmful to various metals including stainless steel gold etc e Use of some detergent solutions may leave a surfactant residue on the gold connector surface depending on the strength of the solution and how thoroughly the residues are rinsed off This may result in intermittent cord alarms The residue may be removed by use of an alcohol soaked swab rotated completely around the external gold connector surfaces e Certain cleaning chemicals may negatively affect metals such as the gold connectors Refer to your cleaning products Material Safety Data Sheet MSDS to ensure that they are not corrosive or harm
7. e AEM Cord do not touch the shield connector and the patient simultaneously In fault conditions leakage current in excess of limits may be present e Explosion Hazard Do not use electrosurgery in the presence of flammable solutions e g alcohol or in an oxygen rich environment e Laparoscopic surgery may result in gas embolism due to insufflation of gas into the abdomen e Pulling or tugging cords can result in breaking of internal conductors causing intermittent alarms or sparking and burning of insulation during use The AEM Monitor is not designed to detect or prevent an arc in the event of a broken active wire e Keep electrical connections dry while in use to prevent potential conduction of HF current to the user e Damaged external insulation AND incorrect setup of the AEM Monitor may result in a risk of unintended patient burn shock or fire hazard Do not use product having damaged insulation e Good operating room practice suggests that connections of accessories to electrosurgical generators be made only while the generator is Off or on Standby e Use these instruments only in conditions that assure adequate visualization to minimize risk of misapplied electrosurgical energy e Keep ESU power setting as low as possible for the intended purpose to minimize unintended burns e Asingle AEM instrument must be the sole conductor of energy to tissue Do not conduct energy by touching an AEM instrument to a second instrument
8. ent until there is no gap between the instrument and adapter Proper assembly of the adapter to instrument is accompanied by an audible click During Use e Extend the sheath tube over the electrode tip prior to insertion into or removal from the trocar cannula The extended sheath position is important in preventing patient injury or instrument damage e Pull the sheath tube back prior to activation of the device to prevent unintended electrical energy from arcing through the aspiration holes of the sheath e Always use the electrode with the sheath in place Use without the sheath may allow arc from shaft in Zone 1 to tissue in an unintended location e The active electrode should not be activated until it is in close proximity to tissue This minimizes risk of contacting unintended tissue e Activating the electrosurgical unit simultaneously with the suction irrigation function may alter the path of the electrical energy away from target tissues CAUTION e Any modification of the instrument including bending of the tip may cause permanent product damage such as breakage or reduce the life of the instrument Disassembly ES3700 series Permanent Adapter amber color CAUTION When using an ES3700 series Permanent Adapter do not disassemble the adapter and SIE instrument for reprocessing Product damage will result if the instrument and adapter are disassembled ES3800 series Removable Adapter black color Twist the
9. ful to various metals including stainless steel gold etc e Do not use metal brushes or brushes larger than the recommended sizes Instrument damage will occur e Do not use a scratch pad or other abrasive cleaner to clean the Electrode tip Shaft or Sheath Tube Instrument damage will occur NOTE e Used instruments are considered medical waste Dispose of in accordance with local regulations 01976 006 2012 04 2of4 AEM Suction Irrigation Electrodes and Adapters Instructions For Use Care Cleaning Automated washer disinfector systems are not recommended as the sole cleaning method for surgical instruments An automated washer disinfector system may be used as a follow up to manual cleaning but is not required CAUTION e When using an ES3700 series Permanent Adapter amber color do not disassemble the adapter and SIE instrument for Sheath Tube Using a 6mm 1 4 long handled soft bristle brush clean the inner lumen using complete strokes while immersed Push the brush all the way through the lumen and pull it back several times Using a soft bristle brush use a back and forth motion and brush all sheath surfaces with particular attention paid to crevices grooves fittings tip and joints See figure in Step 5 ENCISIGN Sterilization Monitoring sterility using Geobacillus stearothermophilus spore strips is recommended CAUTION
10. l be free from defects in materials and workmanship under normal use and service as specified in these Instructions for Use Care for the period of six months from date of purchase or upon reaching an end of life indicator including Maximum Number of Uses whichever occurs first Any evidence of unauthorized modification or repair of this device will void the warranty See AEM Monitor Operator Service Manual for details of Limitations Disclaimer and Exclusions Return of Used Product If for any reason this product must be returned to ENCISION a returned goods authorization is required prior to shipping Appropriate return instructions may be obtained from ENCISION Product ENCISION reserves the right to amend modify or to change any product to introduce new products to withdraw products and otherwise vary product specifications at any time without notice ENCISION and AEM are registered trademarks of ENCISION Inc KLENZYME and MANU KLENZ are registered trademarks of Steris Corporation Stryker is a registered trademark of Stryker Corporation Federal USA law restricts this device to sale by or on the order of a physician Consult Instructions for Use amp Q Latex Free Made in USA aaa Manufactured by ENCISION Inc 6797 Winchester Circle Boulder CO 80301 USA Ph 303 444 2600 Fax 303 444 2693 C 1275 Applies only to ES3800 Series Adapters Ec Rer Authorized Representa
11. roscopic procedures should be performed only by surgeons having adequate training and familiarity with laparoscopic techniques and who are also knowledgeable about anatomy and pathology as well as the complications hazards risks and benefits of the procedure Indications Intended Use Encision s Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures AEM instruments incorporate the use of AEM technology and are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor Contraindications These instruments are not intended for use when laparoscopic electrosurgical techniques are contraindicated These instruments have not been shown to be effective for tubal sterilization procedures and should not be used for these procedures Instructions For Use Prior to Use Thoroughly read these instructions and the instructions in the AEM Monitor Operator Service Manual Reusable components are supplied non sterile Refer to Reprocessing Instructions prior to use Inspect the instrument for proper assembly and function See End of Life Indicators ENCISIGN AEM System Setup See laminated Setup Sheet 00701 when using the ES9005 series AEM Cord Adapter and 02678 when using the ES9015 Universal Adapter While connecting th
12. s 2 Enzyme spray with hot tap water for 1 15 minutes Temperature 132 C 270 F minimum 5 Electrode and Adapter Using a 2mm 1 16 long 3 Rinse with hot or cold water for at least 20 seconds Duration 20 minutes minimum handled soft bristle brush clean the inner lumens using 4 Detergent wash with hot tap water for 1 20 minutes Dry Time 20 minutes minimum complete strokes while immersed Push the brush all the 5 Hot water rinse for at least 20 seconds Gravity Steam FLASH Unwrapped way through the lumens and pull it back several times 7 z z for each component For Gyrus ACMI adapters with pin Thermal rinse 80 C to 98 C 176 F to 208 F for 1 5 Temperature 132 C 270 F minimum also use a 1 8mm soft bristle brush to clean around the _ Duration 16 minutes minimum pin Use the 3 2mm or 1 8mm brushes as appropriate 7 Hot air dry use low temperature setting for 0 10 Flash Sterilization is not recommended except in to thoroughly and effectively clean the adapter lumen minutes emergency situations including the inner lumen area around the pin NOTE r e The washer disinfector manufacturer s instructions should be Using a soft bristle brush use a back and forth motion and brush all surfaces with particular attention paid to Cord Connector crevices grooves fittings tip and joints aS lt ie or strictly adhered to 01976 006 2012 04
13. tive according to MDD93 42 EEC MDSS GmbH Schiffgraben 41 30175 Hannover Germany Printed in USA Copyright 2012 Encision Inc 01976 006 2012 04 4of4
14. upport manual cleaning of devices Cycle time 5 minutes Step Description prior to cleaning and sterilization maximum Do not exceed water temperatures above 1 Allow the instrument to dry thoroughly prior to 2 Immerse all components in KLENZYME or equivalent 50 C 122 F sterilization blood dissolving enzymatic solution prepared per 3 Place instruments in a suitable washer disinfector basket 2 See Caution above regarding removal of detergent manufacturer s instructions for at least 5 minutes and and process through a standard instrument washer solution from the connector surface using an alcohol gently agitate Soak longer if proteinaceous material is disinfector cleaning cycle See Table listing typical cycles swab prior to sterilization present 3 Steam Sterilization assembled or disassembled 3 Remove the components from the enzyme solution and Prevac 2 layers of Sterile Wrap or Unwrapped rinse thoroughly under running tap water minimum of 5 ei 3 minutes om al Typical Automated Washer Disinfector Cycle for Temperature 132 C 270 F minimum Surgical Instruments Duration 4 minutes minimum 4 Immerse all components in MANU KLENZ or equivalent ot Step Description Dry Time 20 minutes minimum detergent solution prepared per manufacturer s instructions and clean all surfaces with a soft bristle 1 Prewash with cold tap water for 1 10 minutes Gravity Steam 2 layers of Sterile Wrap brush including any hard to reach area
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