Bipolar Forceps and Accessories Instructions

en US Federal Law restricts this device to sale by or on the order of a physician only.

Catalog Numbers All products covered by these instructions are listed in the appendix.

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Indications for Use The Bipolar Forceps are designed to grasp, dissect and coagulate selected tissue. They must be connected to the bipolar output of an electrosurgical generator using a suitable bipolar cable and must only be used with parameters for bipolar coagulation.

How Supplied Devices are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.

Limitations on Reprocessing Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to use.

Contraindications Bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. Adverse events reported while using bipolar electrosurgical devices include: •

Inadvertent activation with resultant tissue damage at the wrong site and/or equipment damage.

•

Fires involving surgical drapes and other combustible materials have been reported.

•

Alternate current pathways resulting in burns where the patient or physician or assistant is in contact with exposed metal.

•

Explosions caused by electrosurgical sparking in a flammable gas environment (i.e. explosive anesthetic gases).

•

Organ perforation. Sudden massive hemorrhage.

Warnings Devices shall be used in accordance with these Instructions for Use. Read all sections of this IFU prior to use. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to the health care provider or the patient. Do not exceed a maximum output of 500 Vp (or 300 Vp respectively, depending on model; refer to catalog) of your generator.

Cautions If there are any variations between these Instructions for Use and either your facility’s policies and/or your cleaning/sterilizing equipment manufacturer’s instructions, those variations should be brought to the attention of the appropriate responsible hospital personnel for resolution before proceeding with cleaning and sterilizing your devices. Use of a device for a task other than what it is intended for will usually result in a damaged or broken device. Prior to use, inspect devices to ensure proper function and condition. Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage. Special safety precautions should be observed when using electrosurgical instruments. Never use the instruments in the presence of flammable or explosive substances. The instrument may not be laid down on the patient.

1

Electrosurgical instruments can pose a significant shock, burn or explosion hazard if used improperly, incorrectly or carelessly. Avoid touching or grounding electrosurgical instruments to non-insulated instruments, scopes, trocar sleeves, etc. All persons using such devices should be knowledgeable in the use and handling of laparoscopic instruments, coagulation equipment, their accessories and other related equipment. Do not use in presence of flammable liquids or anesthetics.

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Electrosurgical generators used with these devices are designed to cause destruction of tissue and are inherently dangerous if operated improperly. Follow all safety precautions and instructions supplied by the manufacturer of the electrosurgical generator. The electrode tip must always be in full view before activating power. Apply power only when electrode tip is in full contact with the tissue selected for coagulation. Electrode tip must not come in contact with other metal instruments during use. Failure to observe these cautions and contraindications may result in injury, malfunction or other unanticipated occurrences or events for the operator, staff and/or the patient. Only the cleaning and sterilization processes which are defined within these Instructions for Use have been validated. Use only neutral pH (6-8) detergent solutions.

Pre-processing Instructions Initiate cleaning of device within 2 hours of use. Transport devices via the institutions established transport procedure. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces. Note: that applicable device disassembly should not require any mechanical tooling (i.e. screwdriver, pliers etc.) unless otherwise indicated.

Manual Cleaning Manual Cleaning Process - Enzymatic/neutral pH Detergent Note: Steps 5, 6, 7, 9, and 11 pertain to only devices with lumens. 1. Ensure all pre-processing instructions are followed prior to cleaning. 2. Prepare the enzymatic/neutral pH detergent solution, utilizing drinking water with a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer’s instructions. 3. Place the device in the open/relaxed position with flush port open. Completely immerse the device in the detergent solution and allow it to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time. 4. Using a soft bristled brush, remove all visible soil from the device. Actuate the device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent solution be changed when it becomes grossly contaminated (bloody and/or turbid). 5. For lumen devices, use a soft bristled brush with a brush diameter and length that is equivalent to lumen diameter and length. Scrub the lumen (i.e. angulated/nonangulated positions) until no visible soil is detected in the lumen rinsing step below. 6. For lumen devices, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of detergent solution utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times), ensuring all fluid exiting the lumen is clear of soil.

2

Dimensions checked:_________________ Copy checked:______________

Proofed by:______________________________ Date:_______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

7. For lumen devices, if visible soil is detected during the final lumen flush, re-perform brushing and flushing of the lumen. Note: the final rinse steps (8 and 9) below should be performed with treated water: deionized, distilled or reverse osmosis. If drinking water is used as part of the final rinse, ensure corrosion does not occur. 8. Rinse the device by completely immersing it in treated water with a temperature range of 27°C to 44°C (81°F to 111°F), for a minimum of 30 seconds to remove any residual detergent or debris. 9. For lumen devices, following the rinsing step, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of treated water utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times). 10. Dry the device with a clean, lint-free towel. 11. For lumen devices, manipulate the device to allow rinse water to drain from the lumen. 12. Visually examine each device for cleanliness. 13. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean.

Automatic Cleaning Automatic Cleaning Process - Enzymatic/neutral pH Detergent • Ensure all pre-processing instructions are followed prior to cleaning. • Clean the devices via the automatic cleaning parameters below. Phase

Minimum Recirculation Time

Water Tempurature

Detergent Type and Concentration (If applicable)

Pre-Wash

15 Seconds

Cold Drinking Water 1°C - 16°C (33°F - 60°F)

N/A

1 Minute

• Detergent: pH-neutral/enzymatic Hot Drinking Water • Concentration: 43°C - 82°C Per the detergent (110°F - 179°F) manufacturer’s recommendations

Wash

2 Minutes

• Detergent: pH-neutral cleanser Hot Drinking Water • Concentration: 43°C - 82°C Per the detergent (110°F - 179°F) manufacturer’s recommendations

Rinse

15 Seconds

Hot Drinking Water 43°C - 82°C (110°F - 179°F)

N/A

Pure Rinse

10 Seconds

Treated Water (Hot) 43°C - 82°C (110°F - 179°F)

N/A

Drying

N/A

N/A

N/A

Enzyme Wash

•

For lumen devices, manipulate the device to allow rinse water to drain from the lumen. • If visible moisture is present, dry the instrument with a clean, lint free towel. • Visually examine each instrument for cleanliness. • If visible soil remains, repeat cleaning procedure until the device is thoroughly clean. Note: the final rinse step should be performed with treated water: purified, deionized, distilled or reverse osmosis. If drinking water is used as part of the final rinse, ensure corrosion does not occur.

3

Inspection/Maintenance Proper care and handling is essential for satisfactory performance of any surgical device. The previous cautions should be taken to ensure long and trouble-free service from all your surgical devices. Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts. If any of these conditions appear, do not use the device. Return devices to an authorized repair service center for repair or replacement.

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Before sterilizing, lubricate the device with instrument milk or a steam permeable/ water soluble lubricant, following the lubricant manufacturer’s instructions. Let devices drip dry for three (3) minutes before packaging for sterilization.

Non-Stick Bipolar Forceps The polished tips are made from precious metal and may tarnish, similar to silver. This does not impair the functionality of the instrument. The original gloss can be established by polishing with a silver cleaning cloth.

Bipolar forceps with Irrigation The enclosed stylet should always be inserted in the respective irrigation channel, except during use and cleaning, to prevent clogging of the channel. The irrigation channel must be thoroughly flushed during cleaning. After cleaning, the transmissibility of the channel has to be verified.

Packaging Devices can be loaded into dedicated packaging systems. Sterilization wrap material must be cleared for the applicable sterilization modality by your country’s regulatory body. Use in accordance with packaging manufacturer’s sterilization instructions being sure to protect jaws and cutting edges from damage.

Sterilization All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow sterilant contact of all surfaces. Note that applicable device disassembly should not require any mechanical tooling (i.e. screwdriver, pliers etc.) unless otherwise indicated. All devices with concave surfaces shall be configured so that water pooling does not occur.

Sterilization for United States Market STANDARD PREVACUUM STEAM STERILIZATION CYCLES Prevacuum Steam Sterilization Cycle (U.S. “FDA Compliant – WRAPPED”) • Conditioning Pulses: 3 • Exposure Temperature: 132°C (270°F) • Exposure Time: 4 minutes • Dry Time: 30 minutes • Sterilization Configuration: FDA Cleared Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Prevacuum Steam Sterilization Cycle – Immediate Use Steam Sterilization (U.S. “FDA Compliant – WRAPPED”) • Conditioning Pulses: 3 • Exposure Temperature: 132°C (270°F) • Exposure Time: 4 minutes • Sterilization Configuration: FDA Cleared Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Note: Devices must be used immediately and cannot be stored for later use. Immediate Use Steam Sterilization is not recommended as a routine practice. Refer to ANSI/AAMI ST79 for requirements on when to perform and how to control immediate use steam sterilization. Reference: ANSI/AAMI ST79: (current revision) Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

4

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Sterilization for United States Market STANDARD GRAVITY STEAM STERILIZATION CYCLES Gravity Steam Sterilization Cycle (U.S. “FDA Compliant – WRAPPED”) • Temperature: 132°C (270°F) • Exposure Time: 15 minutes • Dry Time (non lumens): 30 minutes • Dry Time (lumens): 45 minutes • Sterilization Configuration: FDA Cleared Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Gravity Steam Sterilization Cycle (U.S. “FDA Compliant – WRAPPED”) Non lumens­ • Temperature: 121°C (250°F) • Exposure Time: 30 minutes • Dry Time (non lumens): 30 minutes • Sterilization Configuration: FDA Cleared Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin)

Sterilization for outside United States Market STANDARD PREVACUUM STEAM STERILIZATION CYCLES Prevacuum Steam Sterilization Cycle (Outside U.S. Market) • Conditioning Pulses: 3 • Exposure Temperature: 132°C (270°F) - 135°C (275°F) • Exposure Time: 3-18 minutes • Dry Time: 30 minutes • Sterilization Configuration: Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Prevacuum Steam Sterilization Cycle – Immediate Use Steam Sterilization (Outside U.S. Market) • Conditioning Pulses: 3 • Exposure Temperature: 132°C (270°F) - 135°C (275°F) • Exposure Time: 3-18 minutes • Sterilization Configuration: Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Note: Devices must be used immediately and cannot be stored for later use. Immediate Use Steam sterilization is not recommended as a routine practice. In order to control steam sterilization please refer to ISO 17665-1 or ANSI/AAMI ST79. To control immediate use steam sterilization, please refer to ANSI/AAMI ST79. References: ISO 17655-1 (current revision) : Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices - ANSI/AAMI ST79 (current revision) : Comprehensive guide to steam sterilization and sterility assurance in health care facilities

5

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Sterilization for outside United States Market STANDARD GRAVITY STEAM STERILIZATION CYCLES Gravity Steam Sterilization Cycle (Outside U.S. Market) • Temperature: 132°C (270°F) - 135°C (275°F) • Exposure Time: 15 – 30 minutes • Dry Time (non lumens): 30 minutes • Dry Time (lumens): 45 minutes • Sterilization Configuration: Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin) Gravity Steam Sterilization Cycle (Outside U.S. Market) Non lumens • Temperature: 121°C (250°F) • Exposure Time: 30 minutes • Dry Time (non lumens): 30 minutes • Sterilization Configuration: Sterilization Wrap (2 layer-1 ply, or 1 layer -2 ply – examples: cellulose, polypropylene, muslin)

Storage After sterilization, devices should remain in sterilization packaging and be stored in a clean, dry environment.

Warranty CareFusion offers a lifetime guarantee on every surgical device bearing the V. Mueller brand name (unless otherwise noted). Surgical devices are guaranteed to be free of functional defects in workmanship and materials when used normally for its intended surgical purpose. Any V. Mueller device proving to be defective will be replaced or repaired at no cost to the customer.

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 60061 USA 800-323-9088 www.carefusion.com For domestic inquiries email: [email protected] For international inquiries email: [email protected]

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.org

6

Dimensions checked:_________________ Copy checked:______________

DCN 45341 36-10521B 10FEB2021 David Knuth Vernon Hills, IL

Proofed by:______________________________ Date:_______________

Appendix, Annexe, Apéndice, 付録 A230.50S EBP07025-13S EBP07045-53S EBP11025-14C EBP11025-54A EBP11060-14C EBP11060-54A EBP11100-24S EBP15030-21A EBP15100-11S EBP15200-11S EBP17100-11C EBP18030-12D EBP18030-21S EBP18050-41S EBP18100-11A EBP18100-12U EBP18100-31S EBP18150-32S EBP18200-12D EBP18200-21S EBP20030-11A EBP20030-12U EBP20050-32S EBP20100-11A EBP20100-12U EBP20100-22S EBP20100-42S EBP20200-11S EBP20200-21A EBP22030-11A EBP22030-12U EBP22050-32S EBP22100-11A EBP22100-12U EBP22100-22S EBP22100-42S EBP22200-11S EBP22200-21A EBP24030-11A EBP24030-12U EBP24100-11A EBP24100-12U EBP24200-11A EBP24200-12U EBP20150-22S EBP22150-22D EBP18150-21A EBP18150-21S EBP20150-12D EBP20150-12U EBP20150-12S EBP18150-11A EBP17150-11C EBP22150-11S EBP3FCP-VLB NL1807 NL1871-005 NL1873 NL3785-081 NL3785-095 NL3785-102 NL3785-110 NL3785-114 NL3785-119 NL3785-152

A230.51S EBP07025-53A EBP07060-13A EBP11025-14S EBP11025-54C EBP11060-14S EBP11060-54C EBP12100-15S EBP15030-21S EBP15100-21A EBP15200-21A EBP17200-11C EBP18030-12S EBP18030-22S EBP18050-42S EBP18100-11S EBP18100-21A EBP18100-32S EBP18150-42S EBP18200-12S EBP18200-22S EBP20030-11S EBP20030-21A EBP20050-41S EBP20100-11S EBP20100-21A EBP20100-22U EBP20150-32S EBP20200-12D EBP20200-21S EBP22030-11S EBP22030-21A EBP22050-41S EBP22100-11S EBP22100-21A EBP22100-22U EBP22150-32S EBP22200-12D EBP22200-21S EBP24030-11S EBP24030-22S EBP24100-11S EBP24100-22S EBP24200-11S EBP24200-22S EBP22150-22S EBP20150-22U EBP20150-21A EBP20150-21S EBP22150-12D EBP22150-12U EBP22150-12S EBP20150-11A EBP15150-11S EBP24150-11S EBP5FCP-VLBA NL1820 NL1871-010 NL1875 NL3785-082 NL3785-097 NL3785-103 NL3785-111 NL3785-115 NL3785-120 OP34860

A230.63 EBP07025-53S EBP07060-13S EBP11025-24A EBP11025-54S EBP11060-24A EBP11060-54S EBP15030-11A EBP15060-21S EBP15100-21S EBP15200-21S EBP18030-11A EBP18030-12U EBP18050-31S EBP18060-21S EBP18100-12D EBP18100-21S EBP18100-41S EBP18200-11A EBP18200-12U EBP18200-31S EBP20030-12D EBP20030-21S EBP20050-42S EBP20100-12D EBP20100-21S EBP20100-32S EBP20150-42S EBP20200-12S EBP20200-22S EBP22030-12D EBP22030-21S EBP22050-42S EBP22100-12D EBP22100-21S EBP22100-32S EBP22150-42S EBP22200-12S EBP22200-22S EBP24030-12D EBP24050-42S EBP24100-12D EBP24100-42S EBP24200-12D EBP13100-25S EBP24150-22S EBP22150-22U EBP22150-21A EBP22150-21S EBP24150-12D EBP24150-12U EBP24150-12S EBP22150-11A EBP18150-11S EBP3FCP-VLBA NL1802 NL1870-005 NL1872-005 NL1875-005 NL3785-084 NL3785-100 NL3785-104 NL3785-112 NL3785-117 NL3785-121 SP90-6000

27

EBP07025-13A EBP07045-53A EBP11025-14A EBP11025-24S EBP11060-14A EBP11060-24S EBP11100-24A EBP15030-11S EBP15100-11A EBP15200-11A EBP17030-11C EBP18030-11S EBP18030-21A EBP18050-32S EBP18060-22S EBP18100-12S EBP18100-22S EBP18100-42S EBP18200-11S EBP18200-21A EBP18200-41S EBP20030-12S EBP20030-22S EBP20060-22S EBP20100-12S EBP20100-22D EBP20100-41S EBP20200-11A EBP20200-12U EBP20200-41S EBP22030-12S EBP22030-22S EBP22060-22S EBP22100-12S EBP22100-22D EBP22100-41S EBP22200-11A EBP22200-12U EBP22200-41S EBP24030-12S EBP24060-22S EBP24100-12S EBP24150-42S EBP24200-12S EBP18150-22S EBP20150-22D EBP15150-21A EBP15150-21S EBP18150-12D EBP18150-12U EBP18150-12S EBP15150-11A EBP24150-11A EBP20150-11S EBP3FCP-ERB NL1806 NL1870-010 NL1872-010 NL3785-080 NL3785-085 NL3785-101 NL3785-105 NL3785-113 NL3785-118 NL3785-122