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Take-Apart Laparoscopic Instruments Instructions for Use

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V. Mueller ® Take-Apart Laparoscopic Instruments Catalog Numbers: All products covered by these instructions for use are Cautions listed in the appendix. Devices should be handled and operated by healthcare professionals completely familiar with their use, assembly, and disassembly. Use devices for their intended surgical purposes only. Use of a device for other than that for which it is intended will usually result in a damaged or broken device. Examples: 1. Use of a grasper to hold or guide another device. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indications For Use Hand held laparoscopic devices, used with a monopolar electrosurgical current, are intended to be used to grasp/dissect, cut, and cauterize adventitial tissue planes between various ducts and arteries during laparoscopic surgery. 2. Use of a delicate dissector as a grasper. 3. Use of extremely delicate scissors to cut suture. Hand held laparoscopic devices, used without a monopolar electrosurgical current, are intended to be used as a manipulator to lift, move, clamp, extract and for grasping, cutting and/or dissecting, placing or retracting structures or adventitial tissue. 4. Use of a 5 mm grasper or dissector instead of a 10 mm claw extractor forceps to remove excised tissue through cannula. 5. Use of a delicate dissector to remove clips. How Supplied Prior to use, all insulated devices should be inspected to ensure proper insulation. Any interruptions in the coating may compromise the safety of the device. To prevent the possibility of electrical shocks or burns, devices with breaks in the insulation should be returned to an authorized repair service center for repair or replacement. Devices are packaged as non-sterile. Cleaning and sterilization must occur prior to use. Only the cleaning and sterilization processes which are defined within these instructions for use have been validated. Contraindications Do not use devices if they do not satisfactorily perform their intended function or have physical damage. These devices are designed to be used through an abdominal portal, the opening maintained by an introducer or cannula which allows for insertion or removal of the device without damage to surrounding soft tissue. Do not use these devices on patients with pacemakers. Avoid mechanical shock or overstressing the devices which will cause damage. Make sure distal effectors are completely closed prior to insertion or removal through cannulas. Warnings 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 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 patient or health care provider. Use the appropriate sized cannula for the device being used. For example, use a 5 mm device with a cannula with an inner diameter of at least 5.5 mm. The maximum recurring peak voltage for devices applicable to these instructions for use is 2kV. To reduce capacitive coupling, the device should only be activated when in position to deliver energy to the target tissue. Ring handled devices are designed to be held with one finger and the thumb in the ring handles. Do not hold handle in a whole hand pistol grip which applies excessive force and may damage the device. Capacitive coupling could cause burns and increases risk of shock to the patient. Always use caution when inserting or removing instruments through cannula. Lateral pressure on the instrument during removal can damage the working tip, shaft of the instrument and/or insulation. Be sure the tips are closed and the instrument is pulled straight out until completely clear of cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula. When using electrosurgical 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 electrosurgical device so as not to burn the patient and/or surgical drapes. Check for proper grounding of device and patient prior to use. Do not energize the device unless it is visible through the laparoscope. Start with the lowest possible setting on the electrosurgical unit and gradually increase the power to achieve proper cutting and coagulation. The energized device tip 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. Follow manufacturer’s instructions for use for HF generators. Devices were designed to the bipolar output of HF Generators with a maximum of 100 watts and a maximum output voltage of 600 V. Remove protective cover from the monopolar connector on handle prior to use. HF cable used must be completely compatible with the adapter plug. Monopolar laparoscopic devices are not compatible with bipolar cautery cables and generators. They are intended only for monopolar cautery usage. Avoid contact with un-insulated devices and do not use them in the presence of combustible/explosive gases or liquids. All devices must be cleaned and sterilized before use. Large vertical movements inside the trocar sleeve should not be carried out in the activated state. 1 R. Cisneroz - 2013 Proofed by: ____________________________ Date: _____________ Dimensions checked: ______________ Copy checked: _____________

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V. Mueller ® Take-Apart Laparoscopic Instruments Catalog Numbers: All products covered by these instructions for use are

Cautions

listed in the appendix.

Devices should be handled and operated by healthcare professionals completely familiar with their use, assembly, and disassembly. Use devices for their intended surgical purposes only. Use of a device for other than that for which it is intended will usually result in a damaged or broken device. Examples: 1. Use of a grasper to hold or guide another device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Indications For Use Hand held laparoscopic devices, used with a monopolar electrosurgical current, are intended to be used to grasp/dissect, cut, and cauterize adventitial tissue planes between various ducts and arteries during laparoscopic surgery.

2. Use of a delicate dissector as a grasper. 3. Use of extremely delicate scissors to cut suture.

Hand held laparoscopic devices, used without a monopolar electrosurgical current, are intended to be used as a manipulator to lift, move, clamp, extract and for grasping, cutting and/or dissecting, placing or retracting structures or adventitial tissue.

4. Use of a 5 mm grasper or dissector instead of a 10 mm claw extractor forceps to remove excised tissue through cannula. 5. Use of a delicate dissector to remove clips.

How Supplied

Prior to use, all insulated devices should be inspected to ensure proper insulation. Any interruptions in the coating may compromise the safety of the device. To prevent the possibility of electrical shocks or burns, devices with breaks in the insulation should be returned to an authorized repair service center for repair or replacement.

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

Only the cleaning and sterilization processes which are defined within these instructions for use have been validated.

Contraindications

Do not use devices if they do not satisfactorily perform their intended function or have physical damage.

These devices are designed to be used through an abdominal portal, the opening maintained by an introducer or cannula which allows for insertion or removal of the device without damage to surrounding soft tissue.

Do not use these devices on patients with pacemakers.

Avoid mechanical shock or overstressing the devices which will cause damage. Make sure distal effectors are completely closed prior to insertion or removal through cannulas.

Warnings 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 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 patient or health care provider.

Use the appropriate sized cannula for the device being used. For example, use a 5 mm device with a cannula with an inner diameter of at least 5.5 mm. The maximum recurring peak voltage for devices applicable to these instructions for use is 2kV.

To reduce capacitive coupling, the device should only be activated when in position to deliver energy to the target tissue.

Ring handled devices are designed to be held with one finger and the thumb in the ring handles. Do not hold handle in a whole hand pistol grip which applies excessive force and may damage the device.

Capacitive coupling could cause burns and increases risk of shock to the patient.

Always use caution when inserting or removing instruments through cannula. Lateral pressure on the instrument during removal can damage the working tip, shaft of the instrument and/or insulation. Be sure the tips are closed and the instrument is pulled straight out until completely clear of cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula.

When using electrosurgical 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 electrosurgical device so as not to burn the patient and/or surgical drapes. Check for proper grounding of device and patient prior to use. Do not energize the device unless it is visible through the laparoscope. Start with the lowest possible setting on the electrosurgical unit and gradually increase the power to achieve proper cutting and coagulation. The energized device tip 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.

Follow manufacturer’s instructions for use for HF generators. Devices were designed to the bipolar output of HF Generators with a maximum of 100 watts and a maximum output voltage of 600 V. Remove protective cover from the monopolar connector on handle prior to use. HF cable used must be completely compatible with the adapter plug. Monopolar laparoscopic devices are not compatible with bipolar cautery cables and generators. They are intended only for monopolar cautery usage.

Avoid contact with un-insulated devices and do not use them in the presence of combustible/explosive gases or liquids.

All devices must be cleaned and sterilized before use.

Large vertical movements inside the trocar sleeve should not be carried out in the activated state.

R. Cisneroz - 2013

Proofed by: ____________________________ Date: _____________

Dimensions checked: ______________ Copy checked: _____________

Initiate cleaning of device within 2 hours of use. All devices must be processed in the completely open and disassembled (ie. taken-apart) configuration. Note that applicable device disassembly should not require any mechanical tooling (ie. screwdriver, pliers, etc) unless otherwise indicated.

Service and repairs should only be carried out by an authorized repair center identified within this instruction for use. Before each use, insulated devices should be examined separately again for any damage to the insulation, and in case of damage, they should be exchanged. HF cable used must be completely compatible with the adapter plug.

Manual Cleaning

Repair Service

1. Ensure all pre-processing instructions are followed prior to cleaning. 2. Prepare the enzymatic / neutral pH detergent solution, utilizing tap water with a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer’s instructions. 3. Place device in the open/relaxed position with flush port open, and completely immerse in the detergent solution and allow device 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 device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent / solution is 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. 7. For lumen devices, if visible soil is detected during the final lumen flush, re-perform brushing and flushing of the lumen. 8. Rinse the device by completely immersing in tap 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 tap 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.

Return devices for maintenance and repair to:

Pre-processing Instructions

National Repair Center 2675 South Milford Rd. Suite B Highland, MI 48357 For return shipment instructions, please call 1-800-323-9088. Note: All devices being returned for maintenance, repair, etc. must be cleaned and sterilized per these instructions for use prior to shipment.

Packaging When sterilizing by autoclave, the device should be wrapped in a lint-free surgical towel or qualified autoclave package such as sterilization wrap. Sterilization wrap material must be cleared for the applicable sterilization modality by your country’s regulatory body.

Sterilization Sterilization of devices may be accomplished by steam autoclave. 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 device. Please consult with the sterilizer manufacturer or your facility policy for specific guidelines and instructions. The following parameters are for the devices covered by these instructions.

Prevacuum Steam Sterilization Parameters: Minimum Preconditioning Pulses: 3 Minimum Temperature: 132°C (270°F) Minimum Exposure Time: 3 minutes Minimum Dry Time: 30 minutes Sterilization Configuration: Individually Wrapped (2 layer 1-ply or 1 layer 2-ply) Note: This device tip, handle, and flushing port (if applicable), should be kept in the open position when sterilized. The use of “flash” sterilization is not recommended, as it will shorten the life of laparoscopic devices.

Storage

Automatic Cleaning

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

In addition to manual cleaning, you may use an ultrasonic machine to aid in the manual cleaning. If you wish to use automatic cleaning for these devices, you must follow the washer manufacturer’s recommendations specific to these types of devices. Most washer manufacturers have specific washing equipment for these types of devices.

Inspection/Maintenance It is important that every surgical device is inspected after cleaning and prior to use for damage, sharp edges, raw surfaces, ruptures, cracks, or malfunctioning. All parts should be inspected for burrs, nicks, misalignment or bent components. Insulation material should be free of nicks, gouges, scratches and any exposed metal or breaks in the insulation. All surgical devices should always be handled with great care in transportation, cleaning, maintenance, sterilization, and storage. This is especially valid for cuts, fine points and other sensitive areas. Surgical devices corrode and their functionality is influenced when they come into contact with corrosive substances. Do not place devices in acidic or strong detergents. Replace brittle and cracked sealing caps. If any of these conditions appear, do not use the device.

R. Cisneroz - 2013

Proofed by: ____________________________ Date: _____________

Dimensions checked: ______________ Copy checked: _____________

Assembly Instructions Applicable to Products in Table 1

3. With the insert jaw closed and the handle open (just like you would open a pair of scissors), place the “ball” of the insert into the cutout of the handle; then squeeze the handle shut, and keep it shut. The jaw tips must be closed to ensure proper fit into handle.

1. Push the insert into the handle’s outer shaft such that the insert fully seats into the outer shaft. Some rotation of the tip may be necessary to align the tip notches and the outer shaft slots. 2. While holding the outer shaft, rotate the insert, with jaws closed, counter clockwise 45° until tight. Notches

Insert 4. Turn the nut counterclockwise onto the handle. Now the device is ready to use.

Outer Shaft Slots

Disassembly NOTICE: The device cannot be assembled further if the tip is not seated correctly. If the insert spins more than 45°, insure that the notches are fully inserted into the outer shaft slots.

1. Unscrew the nut on the handle clockwise. 2. Open the handle (just like you would open a pair of scissors) and lift the “ball” of the insert out of the cutout area.

3. Open the handle completely and insert the shaft assembly into the handle. Tighten the outer shaft to the handle by turning the red colored screw connector. The jaw tips must be closed to ensure proper fit into handle.

Red Screw Connector

3. Firmly grasping the shaft with both hands, press the little “ball” on a hard surface until the insert detaches from the shaft.

Handle

4. Check the device for smooth operation prior to use.

Disassembly 1. Open the handle completely. Loosen the outer shaft by turning the red colored screw connector. Slide outer shaft away from handle. 2. While holding the outer shaft, rotate the insert clockwise 45° until loosened. Slide the insert from the outer shaft. 3. Clean and sterilize immediately. Note: If device has been received in a pre-assembled configuration, user must disassemble and follow appropriate cleaning, sterilization, and functional check procedures prior to use.

4. Pull the insert out of the shaft. Now you will have 3 separate pieces: a handle, a shaft with a nut, and an insert.

End of Assembly and Disassembly instructions for products in Table 1 Assembly Instructions Applicable to Products in Table 2 1. Slide the insert into the shaft.

2. Notice the tongue and groove configuration. The insert should snap firmly into the shaft.

End of Assembly and Disassembly instructions for products in Table 2

R. Cisneroz - 2013

Proofed by: ____________________________ Date: _____________

Dimensions checked: ______________ Copy checked: _____________

Warranty

Appendix

V. Mueller offers a ninety (90) day warranty against failure in normal use. This warranty does not cover routine re-shaping and refurbishing, or repair of damaged caused by misuse, or failure to care for the device as described in the instructions for use. It does not cover devices after they have been repaired, refurbished, or sharpened by anyone other than an authorized service center.

All product codes covered by these instructions are listed in the following tables.

Table 1 256.00010U 256.00020B 256.00310U 256.00320B 256.01010U 256.01020B 256.01410U 256.01420B 256.02010U 256.02020B 256.02410U 256.03010U 256.03020B 256.03410U 256.03420B 256.05010U 256.05020B 256.05410U 256.05420B 256.06010U 256.06020B 256.06310U 256.06320B 256.07330U 256.08030U 256.10030U 256.12010U 256.12020B 256.12410U 256.12420B 256.13010U 256.13020B 256.13410U 256.13420B 256.15010U

Any type of misuse or abuse of the device and repair or modification by an unauthorized repair representative will render the warranty void. CareFusion assumes no liabilities if the device is misused, abused, or repaired or modified by an unauthorized party. Any adverse event must be reported to the appropriate V. Mueller authorized representative. IEC Classification: BF Applied Parts

Contact Information For general inquires or return shipment instructions, please contact: CareFusion V. Mueller Instrumentation 1500 Waukegan Rd McGaw Park, IL 60085 1-800-323-9088 www. CareFusion.com/V. Mueller 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

256.15020B 256.15410U 256.15420B 256.16030U 256.18010U 256.18020B 256.18410U 256.18420B 256.19010U 256.19020B 256.19410U 256.19420B 256.21010U 256.21030B 256.21410U 256.21420B 256.23010U 256.23020B 256.23030U 256.23410U 256.23420B 256.23430U 256.24010U 256.24020B 256.24410U 256.24420B 256.28010U 256.28020B 256.28410U 256.28420B 256.29010U 256.29020B 256.29410U 256.29420B 256.31010U

256.31020B 256.31410U 256.31420B 256.33010U 256.33020B 256.33410U 256.33420B 256.34010U 256.34020B 256.34410U 256.34420B 256.35010U 256.35020B 256.35410U 256.35420B 256.36010U 256.36020B 256.36410U 256.36420B 256.37030U 256.37330U 256.60010U 256.60020B 256.60310U 256.60320B 256.61010U 256.61020B 256.61310U 256.61320B 256.62010U 256.62020B 256.62310U 256.62320B 256.66010U 256.66020B

256.66310U 256.81420B 256.66320B 256.83010U 256.70010U 256.83020B 256.70020B 256.83410U 256.70310U 256.83420B 256.70320B 256.84010U 256.71010U 256.84020B 256.71020B 256.84410U 256.71310U 256.84420B 256.71320B 256.85010U 256.72010U 256.85020B 256.72020B 256.85410U 256.72310U 256.85420B 256.72320B 256.86010U 256.73010U 256.86020B 256.73020B 256.86310U 256.73310U 256.86320B 256.73320B 256.88010U 256.75010U 256.88020B 256.75020B 256.88410U 256.75410U 256.88420B 256.75420B 256.90010U 256.76010U 256.90020B 256.76310U 256.90310U 256.78010U 256.90320B 256.78020B 256.9900RU 256.78310U 256.99010U 256.78320B 256.99020B 256.79010U 256.99030U 256.79020B 256.99100U 256.79410U 256.99300U 256.79420B 256.99400U 256.81010U 256.99800U 256.81020B 256.81410U

F256.13010 F256.13110 F256.13410 F256.13810 F256.14410 F256.14810 F256.15010 F256.16030 F256.17010 F256.18010 F256.20020 F256.21010 F256.21020 F256.21410 F256.23010 F256.23020 F256.23030 F256.23410 F256.24020 F256.24810

F256.25010 F256.28010 F256.29010 F256.31020 F256.31810 F256.34010 F256.34020 F256.34420 F256.44010 F256.44011 F256.44020 F256.44710 F256.46010 F256.46020 F256.46610 F256.46710 F256.47610 F256.47710 F256.48010 F256.48610

F256.61010 F256.61020 F256.61310 F256.62020 F256.65010 F256.66010 F256.70020 F256.70210 F256.71010 F256.71020 F256.75010 F256.75410 F256.77010 F256.77810 F256.78010 F256.78310 F256.79020 F256.81010 F256.81410 F256.82030

Table 2 F256.00010 F256.00020 F256.00110 F256.01010 F256.01020 F256.01210 F256.01410 F256.02020 F256.05010 F256.05110 F256.06010 F256.06020 F256.07030 F256.08030 F256.10030 F256.10230 F256.10330 F256.11010 F256.12010 F256.12020

V. Mueller is a registered trademark of CareFusion Corporation or one of its subsidiaries. © Copyright 2011, 2010, 2013, CareFusion Corporation or one of its subsidiaries. All rights reserved. Distributed by

CareFusion 1500 Waukegan Road McGaw Park, IL 60085 U.S.A. CF36-1546A •

2013-08

R. Cisneroz - 2013

Proofed by: ____________________________ Date: _____________

Dimensions checked: ______________ Copy checked: _____________

F256.83010 F256.84010 F256.86010 F256.86020 F256.86210 F256.88110 F256.90210 F256.90410 F256.99004 F256.99005 F256.99010 F256.99020 F256.99030 F256.99100 F256.99200 F256.99300 F256.99400 F256.99600 F256.99700 F256.99800

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