Instructions for use - V. Mueller Catalog
Contents
1. 60061 U S A 800 323 9088 www carefusion com For domestic inquiries email GMB VMueller Cust Support carefusion com For international inquiries email GMB SIT International Team carefusion com Other Resources To learn more about sterilization practices and what is required of manufacturers and end users visit www aami org www aorn org or www iso org2. 18 LA8518 45 LA8519 LA8520 LA8520 45 LA8521 LA8521 45 LA8522 LA8522 45 LA8523 LA8523 45 LA8524 LA8524 45 LA8525 LA8525 45 LA8526 LA8526 45 LA8600 LA8601 LA8602 LA8603 LA8604 LA8605 LA8606 LA8607 LA8610 LA8611 LA8612 LA8615 LA8616 LA8617 LA8627 LA8628 LA8629 LA8630 LA8705 LA8706 LA8707 LA8708 LA8710 LA8805 0 LA8805 30 LA8810 0 LA8810 30 LA8810 45 Indications for Use The instrument is intended to be used by qualified physicians to provide access illumination and visualization of internal structures and for manipulating soft tissue grasping cutting coagulating dissecting and suturing in a wide variety of diagnostic and therapeutic laparoscopic urologic closed and minimally invasive procedures It is inserted via a trocar sleeve and is used to prepare coagulate and cut tissue How Supplied Devices are packaged as non sterile Cleaning and sterilization of devices must occur prior to use Limits on Reprocessing For all monopolar electrodes the useful life of this product is lt 50 cycles and lt 2 years Warning Attention Risk of damage the instrument is a precision device Careful handling is important for the accurate functioning of this product Improper external handling e g bending banging dropping etc may cause product malfunction Devices shall be used in accordance with these Instructions for Use Read all sections of this insert prior to use Improper use of these devices may cause a serious injury Electrosu
3. 30 minutes 250 F 121 C 45 minutes e 15 minutes 270 F 132 C 45 minutes e 10 minutes 275 F 135 C 30 minutes Prevacuum Sterilization Cycle Exposure Time Temperature Drying Time e 4 minutes 270 F 132 C 30 minutes e 3 minutes 275 F 135 C 16 minutes Note This instrument tip handle and flushing port where applicable should be kept in the open position when sterilized Autoclave temperatures should not exceed 280 F 138 C as handles insulation or other non metallic parts may be damaged Warranty These CareFusion V Mueller distributed instruments offer a one 1 year warranty against failure in normal use and lifetime warranty against manufacturer and material defects This warranty does not cover routine re sharpening and refurbishing or damage caused by overstress mechanical shock improper processing or failure to care for the instrument as described in the instructions for use Alteration or modification of any of these devices will result in immediate loss of warranty Repair Service Regardless of age if any V Mueller device requires service return the device to an authorized repair service center For repairs outside the U S please contact your local distributor Note All devices being returned for maintenance repair etc must be cleaned and sterilized per these instructions prior to shipment Contact Information CareFusion 75 North Fairway Drive Vernon Hills IL
4. V Mueller Reusable Laparoscopic Instruments Catalog Code LA6229 LA6461 LA6461 45 LA6462 LA6466 LA6471 LA6472 LA6476 LA6504 LA6534 LA6538 LA6543 LA6558 LA6590 LA8101 LA8102 LA8103 LA8103 45 LA8104 LA8104 45 LA8105 LA8105 45 LA8105P LA8106 LA8106 45 LA8107 LA8108 LA8108 45 LA8108P LA8201 LA8201P LA8202 LA8203 LA8203 45 LA8204 LA8204 45 LA8204P LA8205 LA8206 LA8207 LA8208 LA8209 LA8209P LA8210 LA8211 LA8211 45 LA8212 LA8213 LA8213 45 LA8214 LA8214 45 LA8214P LA8215 LA8215 45 LA8215P LA8216 LA8217 LA8217 45 LA8217P LA8218 LA8219 LA8220 LA8220P LA8221 LA8221 45 LA8222 LA8223 LA8223 45 LA8223P LA8224 LA8224 45 LA8225 LA8226 LA8227 LA8228 LA8228 45 LA8229 LA8230 LA8231 LA8232 LA8233 LA8233 45 LA8234 LA8234 45 LA8234P LA8235 LA8236 LA8237 LA8238 LA8238P LA8239 LA8239 45 LA8239P LA8240 LA8241 LA8241 45 LA8242 LA8242 45 LA8243 LA8244 LA8244 45 LA8245 LA8245 45 LA8246 LA8246 45 LA8247 LA8247 45 LA8250 LA8250 45 LA8252 LA8252 45 LA8254 LA8254 45 LA8270 LA8271 LA8272 LA8273 LA8274 LA8275 LA8276 LA8277 LA8278 LA8279 LA8280 LA8281 LA8282 LA8284 LA8300 LA8301 LA8302 LA8302P LA8303 LA8304 LA8305 LA8306 LA8307 LA8307 45 LA8410 LA8411 LA8412 LA8415 LA8416 LA8500 LA8500 45 LA8501 LA8502 LA8503 LA8503 45 LA8504 LA8504 45 LA8505 LA8505 45 LA8506 LA8506 45 LA8507 LA8507 45 LA8508 LA8508 45 LA8509 LA8509 45 LA8510 LA8510 45 LA8511 LA8511 45 LA8512 LA8513 LA8513 45 LA8514 LA8514 45 LA8515 LA8515 45 LA8517 LA8517 45 LA85
5. e they should be lubricated with non silicone antimicrobial water soluble solution for 30 40 seconds Do not rinse or towel dry after lubrication Do not use mineral oil petroleum jelly or silicone sprays which can inhibit sterilization and cause build up in the crevices of the instruments Sterilization should follow lubrication 11 Return items to designated storage container All ring handled instruments should be placed on pins or racks Instruments with flushing port caps should have the cap left in the open position Proceed with sterilization Distributed By CareFusion wall 75 North Fairway Drive Vernon Hills IL 60061 USA 36 3123F Q CareFusion Sterilization Steam sterilization is recommended for these instruments Time and temperature parameters required may vary according to type of sterilizer cycle design and packaging material Each institution is responsible for determining the efficacy of the sterilization schedule used to sterilize this laparoscopic instrument Please consult with the maker of your sterilizer or your facility s policy for specific guidelines and instructions The following is provided for informational purposes Open flush port cap prior to sterilization When sterilizing by autoclave the device should be wrapped in a lint free surgical towel or qualified autoclave package and sterilized using the following cycles Gravity Sterilization Cycle Exposure Time Temperature Drying Time e
6. gical instruments on patients with pacemakers Do not use in the presence of flammable liquids or anaesthetics Refer to the labeling and user manual for the electrosurgical generator for additional information on contraindications on electrosurgical or laparoscopic use Caution Federal USA law restricts this product to sale by or on the order of a physician Instructions for Use of Grasper Dissector Scissors Needle Holder Retractors 1 Prior to use clean and sterilize instrument as per instructions 2 Inspect instrument for any signs of defects 3 Under laparoscopic visualization insert instrument through appropriate cannula advancing until desired depth is obtained 4 Actuate handle to grasp cut move etc Instructions for Use of Electrosurgical Capable Instruments 1 Refer to generator manufacturers instructions prior to use 2 Apply grounding pad to patient and properly connect to generator 3 Attach monopolar electrosurgical active cord to electrosurgical connection on the instrument s handle and adjust the power using lowest dial setting to achieve the desired surgical effect Check ground and connectors before increasing generator setting Increase generator setting slowly if more current is desired Rx Only Care and Handling Immediately after each surgical procedure clean all instruments thoroughly as follows 1 Remove gross soil from instruments with a disposable sponge moistened with water 2 T
7. ransport devices via the institutions established transport procedure Instruments should be kept moist by adding water or a towel moistened with water to the transport container Prepare enzymatic cleaner Disengage the flushing port cap on Instruments equipped with a flushing port cap Note Delicate instruments should be handled with care avoiding the use of steel wool wire brushes and highly abrasive detergents Only a soft bristle brush should be used 5 The device should be rinsed in deionized water and brushed to remove all visible soil Special attention must be paid to slots stops ends hollow tubes and other highly inaccessible areas 6 Using a 20 cc syringe draw 15 ml of enzymatic cleaner Attach syringe to luer fitting and flush out the laparoscopic device Repeat for a total of 3 times 7 Using a second 20 cc syringe flush the laparoscopic device 3 times with 15 ml of deionized water as in step 6 8 All parts should be inspected for burrs nicks misalignment or bent components Insulation material cables and connectors should be inspected for cuts voids cracks tears abrasions nicks gouges scratches and any exposed metal or breaks in the insulation 9 Dry all components including inside channels and highly inaccessible areas thoroughly using a towel or an air pistol to ensure removal of residual moisture which could cause corrosion 10 Since the resposable instruments require reassembly prior to us
8. rgical instruments can pose a significant shock burn or explosive hazard if used improperly incorrectly or carelessly Improper care and maintenance of the device may render the device non sterile prior to patient use and may cause serious injury to the health care provider or the patient Check for proper grounding of instrument and patient prior to use Q CareFusion Laparoscopic procedures should be performed only by physicians having adequate training and familiarity with laparoscopic techniques Refer to current medical literature relative to technique complications and hazards prior to performing any laparoscopic procedure A review of current literature on the particular procedure is suggested prior to surgery A thorough understanding of the principles and techniques of electrosurgery is necessary to avoid shock and burn hazard to the patient operator and operating room personnel The instrument tip when energized by an electrosurgical generator has the potential to burn cut and coagulate tissue Care should be taken when using this device as contact with surrounding tissue in the field can produce excessive tissue burn Verify compatibility of instrumentation and ensure that electrical isolation or grounding is not compromised and that the patient is properly grounded at all times Use lowest dial setting to achieve desired surgical effect Check ground and connectors before increasing generator setting Improper connection
9. s of accessories may result in inadvertent accessory activation or other potentially hazardous conditions Increase generator setting slowly if more current is desired Do not energize the instrument unless it is visible through the laparoscope When using electrosurgery generators be sure to follow the manufacturer s recommendations for patient and staff safety The patient should be grounded by use of a grounding pad which is properly connected to the electrical generator Care should be taken when handling the electrosurgery instrument so as not to burn the patient and surgical drapes Do not rest the instrument on the patient Prior to each use inspect the laparoscopic instrument for defects If damage is evident do not use the instrument return to V Mueller for repair replacement To prevent the possibility of electrical shocks or burns do not use devices with breaks in the insulation Cautions These instruments are not compatible with bipolar cautery cables and generators They are intended only for monopolar cautery usage Activating this device when not in contact with target tissue or when not in position to deliver energy to target tissues for fulguration may cause capacitive coupling Capacitive coupling could cause burns and increases risk of shock to patient To avoid tissue carbonation the operating voltage of the HF generator must not exceed 650 peak voltage Vp for all monopolar electrodes Do not use electrosur
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