snowden-pencer ™ laparoscopic modular slide-lock · disassembly 1. ensure the handle is in the...

36-10169B03-12-18David KnuthVernon Hills, IL

Proofed by: ______________________________Date:______________

Dimensions checked: ________________Copy checked: ____________

Catalog NumbersSnowden-Pencer 5mm & 10mm diameter laparoscopic devices withlumen length up to 450mm long.88-8037, 88-8045, 88-8203, 88-8204, 88-8225, 88-8235, 88-8247,88-8248, 88-8303, 88-8304, 88-8324, 88-8325, 88-8334, 88-8335,88-8347, 88-8348, 88-8424, 88-8425, 88-8434, 88-8435, 88-8447,88-8448, 88-8525, 88-8535, 88-8547, 88-8548

Indications For UseHand held Laparoscopic instruments are intended for grasping,cutting, dissecting, retracting, clamping, and/or biopsy. The devicesare used in conjunction with a laparoscope during laparoscopicprocedures. Instruments should be used only by personnelcompletely familiar with their operation. Using an instrument for atask for which it was not intended may result in a damaged or brokeninstrument.

Contraindications• Do not activate electrodes during use if laparoscopic electrosurgicaltechniques are contraindicated.

• DO NOT USE if use if laparoscopic methods have been contraindicated.

Explanation of SymbolsRefer to the BD Symbols Glossary for symbol definitions at www.bd.com/symbols-glossary.

Supplied ContentsHandle/Tube Assemblies and Reusable inserts are sold separately.

WarningsRisk of Injury and Damage to Products:Failure to read and follow this IFU (Instructions for Use) and the IFUof products used in combination can result in injury or death topatients, users, and third parties as well as damage to the product. Risk of Injury:Do not use instruments with damaged or missing insulation. Inspectinstruments and cables for damage prior to each use. Insulationfailures may result in burns or other injuries to the patient oroperator.There is a risk of injury if active electrodes come into contact withother conductive devices and accessories. The surface of the active electrode may remain hot enough to causeburns after the RF current has been deactivated.Activating the electrosurgical unit simultaneously withsuction/irrigation may alter the path of energy. Aspirate fluid from thearea before activating the instrument. Conductive fluids (e.g., bloodor saline) in direct contact with or in close proximity to an activeelectrode may alter electrical current which may cause unintendedburns to the patient.Incorrectly assembled and damaged devices can lead to injuries tothe patient or operator. Devices and all accessories used incombination must be checked immediately before and after use.Check for missing parts, damaged insulation, loose parts, cracks,broken parts, or bent parts. Verify that devices are fully functional. The use of excessive force may result in medical devices whichmalfunction. Regardless of age, any devices requiring service shouldbe returned to the dealer.If application parts are used outside of the field of vision there is arisk that tissue and accessories could be damaged unintentionally.Always hold the application parts of the active electrode and otherinstruments which transmit energy in a target-oriented manner and inthe field of vision during application.When not in use, stage devices in a visible area not in contact withthe patient to minimize the risk of accidental activation andinadvertent patient contact.

Snowden-Pencer, CareFusion, and the CareFusion logo aretrademarks or registered trademarks of CareFusion Corporation,or one of its affiliates.All other trademarks are property of their respective owners.

Distributed byCareFusion75 North Fairway DriveVernon Hills, IL 60061 USA

© 2013, 2015, 2018, CareFusion Corporation or one of its affiliates.All rights reserved.

36-10169B • 2018-03

Snowden-Pencer™ Laparoscopic Modular Slide-Lock

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Proofed by: ______________________________Date:______________


USE CAUTION when using hybrid trocar systems, (i.e. a combinationof metal and plastic) with monopolar active components, as use ofthese trocars may result in alternate site burns due to capacitivecoupling. Only use hybrid trocar systems when metal is in continuousand complete contact with the patient’s tissue, creating an adequateelectrical return path. Refer to trocar manufacturer for furtherclarification.The non-conductive Luer Port Cap must securely cover the Luer Portduring use.Neither the product nor the product container contains NaturalRubber Latex. Test cuts with scissors of materials containing NaturalRubber Latex may contaminate the device and result in an allergicreaction.Risk of Fire:DO NOT activate the electrode in the presence of flammableanesthetics or oxidizing gases (such as nitrous oxide (N2O) andoxygen) or in close proximity to volatile solvents (such as ether oralcohol), as explosion or fire may occur.DO NOT place instrument near or in contact with flammable materials(such as gauze or surgical drapes). Instruments which are activatedor hot from use may cause a fire.Risk of Infection:Devices ship from manufacturer non-sterile. Clean and sterilize perthese IFU prior to use. Do no reuse devices which are suspected to have been contaminatedwith transmissible spongiform encephalopathy (TSE) agents (prions).

CautionsFederal (USA) law restricts this device to sale by or on the order of aphysician.Incorrect application of medical devices poses a risk of injury. Usersof medical instruments must have an appropriate medicalqualification and be acquainted with the application.Laparoscopic surgery may result in gas embolism due to insufflationof gas into the abdomen.Sharp edges or pinch points may damage personal protectiveequipment such as surgical gloves.Due to the carcinogenic and infectious potential of electrosurgical by-products (such as tissue smoke plume and aerosols), protectiveeyewear, filtration masks, and effective smoke evacuation equipmentshould be used in both open and laparoscopic procedures.

Use instruments only in conditions that assure adequate visualizationto minimize risk of misapplied electrosurgical energy.A singular instrument must be the sole conductor of energy to tissue.Do not conduct energy by touching an instrument to a secondinstrument contacting tissue.Wear of insert clevis may be an indication of impending mechanicalfailure, which may result in component coming loose during use.Proper care and maintenance of hand held laparoscopic instrumentsis essential for safe and effective operation. Prior to each use,instruments should be thoroughly examined for end of life indicatorssuch as broken or worn parts which may inhibit the function.Specifically, instruments used for electro surgery must be checked fornicks, cracks, or damaged insulation. Careful inspection upon receiptand frequent inspection during use for functional integrity isrecommended as a safeguard against possible injury to patient oroperator. Instruments should be used with extreme care wheninserting or removing from the cannula. Lateral pressure on thedevice during removal can damage the working tip, the shaft of thedevice, and/or insulation. Be sure the tips are closed and the device ispulled straight out until completely clear of cannula to avoid catchingvalve assemblies or dislodging the cannula.The non-conductive Luer Port Cap must be installed securely on theflush port during use to minimize insufflation leakage from thepatient. The Luer Port Cap must NOT cover the flush port duringcleaning and sterilization.Use of instrument for a task other than that for which it is intendedmay result in a damaged or broken device. For example:• Use of a delicate dissector as a grasper.• Use of scissors to cut staples.• Use of a 5mm grasper or dissector instead of a 10mm claw extractorforceps to remove excised tissue through cannula.

Incorrect placement of trocars can adversely affect instrumenteffectiveness, patient safety, and operator comfort.Electrosurgical cords must comply with IEC 60601-2-2:2009. Alwaysreference and follow the IFU for Electrosurgical Cords.Electrosurgical Generators must comply with IEC 60601-2-2:2009.Always reference and follow the IFUfor the ESU (ElectrosurgicalGenerator).

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Proofed by: ______________________________Date:______________


(g)

(a)

(i)

(h)

(e)(f)

(c) (d)

Components

a. Handle windowb. Assembly switchc. Insertd. Handlee. Rotation knob

f. End of the insertg. Ratchet engaged h. Ratchet disengagedi. Front ring handlej. Cleaning brush opening

(b)

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(j)

Assembly1. Open non-sterile packaging and remove instrument components.2. Slide insert into shaft, and screw the insert into shaft clockwise

until insert is securely placed into shaft. (Figure 1)

3. Press and hold the assembly switch forward, which is located ontop of the handle behind the rotation knob. (Figure 2)

a. Note: the slide-lock ratchet must be disengaged.

4. While holding the assembly switch forward, press the front ring-handle up and forward, so the handle is now in the completelyopen position. (Figure 3)

a. Note: the top of thefront ring handle willappear behind theassembly switch andyou will be able tosee the end of theinsert in the handlewindow. (Figure 4)

5. Pull the front ring-handle down before releasing the assemblyswitch. (Figure 5)

a. Note: you will hear an audible snap upon connection

b. Note: you will nolonger be able to seethe end of the insertin the handle window.(Figure 6)

6. Open and close the handle to completely assembly. Note: whenproper assembly is achieved the jaws will open and close.


Proofed by: ______________________________Date:______________


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Figure 1

Figure 4

Figure 5

Figure 6

Figure 2

Assembly

Figure 3

Disassembly1. Ensure the handle is in the open position and the ratchet is

disengaged. (Figure 7)

2. Press and hold the assembly switch forward, which is located ontop of the handle behind the rotation knob. (Figure 8)

a. Note: the slide-lock ratchet must be disengaged.

3. While holding the assembly switch forward, press the front ring-handle up. (Figure 9)

a. Note: the top of the front ring handle will appear behind theassembly switch.

4. Pull the front ring-handle down before releasing the assemblyswitch. (Figures 11 & 12)

a. Note: you will hear an audible snap upon connection. b. Note: you will now be able to see the end of the insert in the

handle window.

5. Grasp instrument at the jaw and unscrew the insert by spinningjaw counterclockwise. (Figure 13)

6. Remove insert from shaft. (Figure 14)

7. Follow cleaning and sterilization instructions. To prep theinstrument to run a cleaning brush through the cleaning brushopening, follow assembly steps 2 and 3 and then releaseassembly switch. (Figure 15) A brush can now be fed through thecleaning brush opening. (Figure 16)


Proofed by: ______________________________Date:______________


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Figure 9

Figure 11 Figure 12

Figure 13

Figure 14

Figure 7

Figure 8

Disassembly

Figure 15 Figure 16

Manual Cleaning Instructions for Reusable Inserts1. Prepare a enzymatic/neutral pH detergent in warm water

(15°C - 30°C or 59°F - 86°F) per detergent manufacturer’s IFU.2. Prior to removing inserts from the Handle/Tube Assembly, flush

the device with a minimum of 60mL of pH-neutral/enzymaticdetergent solution through the Luer Port.

3. Completely immerse assembled devices in the pH-neutral/enzymatic detergent solution and allow devices to soakfor a minimum of 5 minutes. Actuate all movable parts during theinitiation of the soak time.

4. Remove inserts from the Handle/Tube Assembly. 5. Ultrasonic clean Inserts in pH-neutral/enzymatic detergent solution

for a minimum of 10 minutes. 6. Using a hand held soft bristle brush, use a back and forth motion

to brush all surfaces of Inserts with particular attention paid tojaws, clevis, linkage mechanism, and crevices.

External Brush Characteristics: Soft nylon (nonmetallic) bristledtooth brush.

7. Rinse Inserts by completely immersing in pH-neutral/enzymaticdetergent solution.

8. If visible soil is detected following the rinse, repeat ultrasonic,brushing, and rinsing steps until visible soil is no longer detected.

9. Rinse the Insert by completely immersing in warm water for aminimum of 30 seconds to remove any residual detergent ordebris.

10.Visually examine each Insert for cleanliness.11.If visible soil remains, repeat cleaning procedure.

Inspection/MaintenanceProper care and handling is essential for satisfactory performance ofany surgical device. The steps in these instructions for use should betaken to ensure long and trouble-free service from all your surgicaldevices. Inspect devices before each use for end of life indicators.Specifically, instruments used for electrosurgery must be checked fornicks, cracks, gaps, or damage to shaft insulation. Careful inspectionupon receipt and frequent inspection during use for end of lifeindicators and functional integrity is recommended as a safeguardagainst possible injury to patient or operator. If any conditions appearwhich would indicate that the device is not safe for use, do not usethe device and return the device to the dealer for investigation.Lubricate prior to sterilizing by immersing for a minimum of 30seconds in instrument milk or a steam permeable/water solublelubricant. Allow devices to drip dry approximately 3 minutes followinglubrication and prior to packaging for sterilization. Follow the lubricantmanufacturer's IFU. Do not use silicon, mineral oil, or petroleumbased lubricants.


Proofed by: ______________________________Date:______________


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Pre-processing Instructions• Initiate cleaning within 30 minutes of use and do not allow soil to dryprior to cleaning.

• Inspect devices for end of life indicators.

Manual Cleaning Instructions for Handle/Tube Assemblies1. Prepare a enzymatic/neutral pH detergent in warm water

(15°C - 30°C or 59°F - 86°F) per enzymatic/neutral pH detergentmanufacturer’s IFU.

2. Prior to removing the inserts from the Handle/Tube Assembly,flush the device with a minimum of 60mL of pH-neutral/enzymaticdetergent solution through the Luer Port.

3. Completely immerse assembled devices in the pH-neutral/enzymatic detergent solution and allow devices to soakfor a minimum of 5 minutes. Actuate all movable parts during theinitiation of the soak time.

4. Remove inserts from the Handle/Tube Assembly. Note: Clean inserts separately per manual cleaning instructions forReusable Inserts.5. Ultrasonic clean devices in pH-neutral/enzymatic detergent

solution for a minimum of 10 minutes. 6. Using a hand held soft bristle brush, use a back and forth motion

to brush all exterior surfaces of devices with particular attentionpaid to Monopolar Post, crevices, grooves, fitting, and joints.

7. Pass a brush through the entire length of the interior lumen aminimum of three (3) times for cleaning prior to sterilization. A brush can be inserted into the Handle Access For Cleaning andremoved by pulling it from the distal end of the Handle/TubeAssembly.

Lumen Brush Characteristics: 5mm diameter with soft nylon(nonmetallic) bristles, 230mm handle length.

External Brush Characteristics: Soft nylon (nonmetallic) bristledtooth brush.

8. Flush the Handle/Tube Assembly with a minimum of 60mL of pH-neutral/enzymatic detergent solution through the Luer Port.Repeat the flush process a minimum of 2 times (i.e. total of 3 times) or until all fluid exiting the lumen is clear of soil.

9. If visible soil is detected during the final lumen flush, repeatultrasonic, brushing and flushing steps until all fluid exiting thelumen is clear of soil.

10.Rinse the devices by completely immersing in warm water for aminimum of 30 seconds to remove any residual detergent ordebris. Flush devices with a minimum of 60ml of warm tap waterthrough the Luer Port. Repeat the flush process a minimum of 2 times (i.e. total of 3 times).

11.Manipulate devices with lumens to allow rinse water to drain fromthe lumen.

12.Visually examine each instrument for cleanliness and repeatcleaning procedure if visible soil remains.


Proofed by: ______________________________Date:______________


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SterilizationHandle/Tube Assemblies may be sterilized with the insert installed.Flush Port Cap must be open during sterilization. Configured devicesso that water pooling does not occur.

Storage Instructions If sterilized In Instrument WrapDevices must remain wrapped and be stored in a clean, dryenvironment to maintain sterility. Follow the Instrument Wrapmanufacturer's IFU.

Storage Instructions If Sterilized In A Rigid ContainerDevices must remain sealed in the rigid container which has beenvalidated to maintain sterility. Follow the Rigid Containermanufacturer's IFU for shelf life.

Product LifeExpected life is greatly dependent upon the care, handling, and use ofthe devices. Product life may be reduced by improper handling,excessive force, or third party modifications.Handle/Tube Assemblies:Use until Handle/Tube Assembly exhibits end of life indicators. End of life indicators include:• Cracked, broken, bent, missing, loose, or damaged components.• Damaged, missing, or modified shaft insulation, especially at the distalend of the tube assembly.

• Impaired mechanical function.

Reusable InsertsUse until Reusable Insert exhibits end of life indicators. End of life indicators include:• Cracked, broken, bent, missing, loose, or damaged components.• Impaired mechanical function.

WarrantyAll Snowden-Pencer instruments are protected by a full service 1 yearwarranty and lifetime warranty against manufacturer defects. Damagecaused to the instrument by overstress, mechanical shock, improperprocessing, or repair by a party other than Snowden-Pencer is notcovered. Repair, alteration or modification of any product by personsother than Snowden-Pencer, or products subjected to misuse orabuse will result in immediate loss of warranty. If Snowden-Pencerinstruments are damaged by accident or when used for a purposeother than originally intended, a repair charge will apply.

Repair ServiceRegardless of age, all instrument repairs must be returned to anauthorized Snowden-Pencer representative, to the address below or toan authorized representative for international repairs. If the repair iscovered under warranty, it will be repaired or replaced at no chargewhen requested in writing. A nominal service charge will be made forrepaired instruments outside the warranty.Note: All instruments being returned for maintenance, repair, etc.must be cleaned and sterilized per these instructions prior toshipment. Send the instrument back to the dealer in a reprocessedstate and in its original packaging.

Contact InformationBD Customer Service800-323-9088 For email inquiries:[email protected] customers outside of the USA, please contact your local distributor.Other Resources: To learn more about sterilization practices and whatis required of manufacturers and end users, visit www.aami.org,www.aorn.org, or www.iso.org.

Prevacuum Steam Sterilization Parameters If Sterilized in Instrument Wrap:Minimum Preconditioning Pulses: 3Minimum Temperature: 132°C (270°F)Minimum Exposure Time: 4 minutesMinimum Dry Time: 20-30 minutesSterilization Configuration: Wrapped (2-layer 1-ply or 1-layer 2-ply)

Prevacuum Steam Sterilization Parameters If Sterilized In A Rigid Container:Minimum Preconditioning Pulses: 3Minimum Temperature: 132°C (270°F)Minimum Exposure Time: 4 minutesMinimum Dry Time: 0 minutesSterilization Configuration: Devices in a Laparoscopic Rack, which is inside of aRigid Container

snowden-pencer ™ laparoscopic modular slide-lock · disassembly 1. ensure the handle is in the...

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