BD
Snowden-Pencer Laparoscopic Ergonomic Modular Instruments Instructions for use
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Snowden-Pencer™ en
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DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL
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fr de it es pt nl sv da fi no el ja cs pl tr ro kr
USA
Laparoscopic Ergonomic Modular Instruments Instruments laparoscopiques ergonomiques modulaires Ergonomische, modulare laparoskopische Instrumente Strumenti modulari ergonomici per laparoscopia Instrumentos ergonómicos desmontables para laparoscopia Instrumentos laparoscópicos modulares ergonómicos Ergonomische laparoscopische modulaire instrumenten Laparoskopiska ergonomiska modulära instrument Laparoskopiske, ergonomiske, modulære instrumenter Ergonomiset osiin purettavat laparoskopiainstrumentit Ergonomiske, flerdelte instrumenter for laparoskopi
Λαπαροσκοπικά εργονομικά αρθρωτά όργανα エルゴノミック腹腔鏡モジュラー器具 Laparoskopické ergonomické modulární nástroje Ergonomiczne laparoskopowe narzędzia modułowe Laparoskopik Ergonomik Modüler Aletler Instrumente laparoscopice modulare ergonomice 인체공학적 모듈식 복강경 장치
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.
Snowden-Pencer, CareFusion, and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation, or one of its affiliates. Valleylab and Force are trademarks of Covidien AG. ConMed is a registered trademark of ConMed Corporation. System 5000 is a trademark of ConMed Corporation. Ellman and Surgitron are registered trademarks of Ellman International, Inc. © 2016, 2018, 2020, CareFusion Corporation or one of its affiliates. All rights reserved. CareFusion Note: Refer to CE mark 75 North Fairway Drive status as shown on Vernon Hills, IL 60061 USA current product labeling. CareFusion France 309 S.A.S. 8 bis rue de la Renaissance 44110 Châteaubriant - France Australian and New Zealand Sponsors: Becton Dickinson Pty. Ltd. 66 Waterloo Road 0123 Macquarie Park, NSW 2113, Australia Becton Dickinson Limited 14B George Bourke Drive Mt. Wellington, Auckland, 1060 New Zealand 36-0151C • 2020-11
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Symbol, Symboles, Symbole, Simboli, Símbolos, Symbolen, Symboler, Symbolit, Σύμβολα, 記号, Symboly, Simgeler, Simboluri, 기호
en fr de it es pt nl sv da fi no el ja cs pl tr ro ko
Consult instructions for use. Consulter les instructions d’utilisation. Bedienungsanleitung einsehen. Consultare le istruzioni per l’uso. Consultar las instrucciones de uso. Consulte as instruções de utilização. Raadpleeg de gebruiksaanwijzing. Se till att konsultera bruksanvisningen. Se brugsanvisningen. Lue käyttöohjeet. Se bruksanvisningen før produktet tas i bruk.
Συμβουλευτείτε τις οδηγίες χρήσης. 使用説明書を参照してください。 Přečtěte si návod na použití. Zapoznać się z instrukcją obsługi. Kullanım yönergelerine bakınız. Consultaţi instrucţiunile de utilizare. 사용 설명서를 참조하십시오.
DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL Dimensions checked:_________________ Copy checked:______________
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Figure, Abbildung, Figura, Afbeelding, Figur, Kuva, Σχήμα, 図, obrázek, Ryc., Şekil, 그림
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(B)
(F) (G)
(K)
(J)
2 (N)
(C)
(D) (E)
1 (H) (J)
(F) (I) (L)
(I) (K) (M)
DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL Dimensions checked:_________________ Copy checked:______________
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Figure, Abbildung, Figura, Afbeelding, Figur, Kuva, Σχήμα, 図, obrázek, Ryc., Şekil, 그림
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en Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician. Catalog Numbers: All reusable product codes covered by these instructions for use are listed in Appendices A and B.
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DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL
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Explanation of Symbols
Refer to the BD Symbols Glossary for symbol definitions at www.bd.com/symbols-glossary.
Device Description
Snowden-Pencer Ergonomic Modular Laparoscopic Instruments are reusable surgical instruments with elongated narrow shafts suitable for surgical manipulation through small incisions. Multiple versions of these instruments are available to accommodate a range of tasks and preferences.
Indications for Use
• All products covered by the following Indications for Use are listed in Appendix A: The Snowden-Pencer™ laparoscopic ergonomic devices are monopolar electrosurgical instruments indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The devices are indicated to mechanically cut, clamp, grasp, and dissect. • All products covered by the following Indications for Use are listed in Appendix B: Snowden-Pencer Ergonomic Modular In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.
Reusable Shaft and Inserts Compatibility
Snowden-Pencer Modular reusable shafts and inserts are intended to be used exclusively with Snowden-Pencer Ergonomic Modular reusable handles.
Single Use Only Sterile Scissors Compatibility
Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors (SP8301, SP8302, SP8303, SP8401, SP8402, and SP8403) are intended to be used with Snowden-Pencer Ergonomic Modular reusable ring handles (SP94 and SP95).
Electrode Cable Compatibility
All Snowden-Pencer Modular products indicated for monopolar electrosurgical use are listed in Appendix A. These devices are compatible with the Unipolar Bovie Cord with universal plug (88-9199) or equivalent.
Generator Compatibility
All Snowden-Pencer Modular products indicated for monopolar electrosurgical use are listed in Appendix A. These devices are only compatible with FDA-cleared high frequency monopolar electrosurgical generators such as the ValleyLab™ Force™ 2 PC, the Conmed® System 5000™, and the Ellman® Surgitron® Dual RF. Refer to the generator manual for more detailed information on using this device under various modes of operation. For Outside United States Market All Snowden-Pencer Modular products indicated for monopolar electrosurgical use are listed in Appendix A. These devices are compatible with IEC compliant high frequency monopolar electrosurgical generators. Refer to the generator manual for more detailed information on using this device under various modes of operation.
How Supplied
Reusable devices are packaged as non-sterile. Cleaning and sterilization must occur prior to use. For the Single Use Sterile Scissors, reference product information for use (IFU# CF36-1833/26-2920) for complete operating and use instructions.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on Snowden-Pencer reusable devices. End of life is determined by wear and damage due to use. For additional guidance, see the Inspection section of these instructions.
Warnings
• Devices shall be used in accordance with these instructions for use. Read all sections of these instructions prior to use. Improper use of this device may cause serious injury. In addition, improper care and maintenance of the device may render the device non-sterile prior to patient use and cause a serious injury to the patient or health care provider. • When not in use, store in a location that is isolated from the patient.
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The following warnings are applicable only to electrosurgical devices listed in Appendix A:
• Prior to use of the instruments in patients who have cardiac pacemakers or other active implants, consult the implanted device manufacturer’s instructions for use. A possible hazard exists due to interference with the intended action of the implanted device or damage to the implanted device. In case of doubt, qualified advice should be obtained. • To prevent the possibility of electrical shocks or burns, do not use devices with breaks in the insulation. • Gas embolism may result from over-insufflation of air, inert gas prior to high-frequency (HF) surgery or laser assist gas. • The Snowden-Pencer Devices are monopolar devices and should only be connected to an electrosurgical generator that is compatible with monopolar devices. • Do not exceed the maximum rated voltage specified. Adjust the electrosurgical generator to a setting appropriate for the maximum peak output voltage. • A dispersive electrode, such as a grounding pad, should be used with the device and electrosurgical generator to prevent burns/injury to the patient when using the monopolar device. Ensure the pad is properly sized and properly placed and always recheck the pad when patient is moved. It is recommended that the device is used with an electrosurgical generator that contains contact quality monitoring (return electrode monitoring) with a signal to indicate there is contact to the patient. • When HF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. In all cases, monitoring systems incorporating HF current limiting devices are recommended. • Conductive fluids (e.g., blood or saline) in direct contact with an active electrode may carry electrical current or heat, which may cause unintended burns to the patient. • Non-flammable agents should be used for cleaning and disinfection wherever possible. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives should be allowed to evaporate before the application of HF surgery. • There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before HF surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton, wool, and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment. • The use of flammable anesthetics or oxidizing gases, such as nitrous oxide (N2O) and oxygen, should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are removed. • To reduce capacitive coupling, the device should only be activated when positioned to deliver energy to the target tissue. • Activating the electrosurgical unit while simultaneously utilizing the suction / irrigation may alter the intended path of the electrical energy away from target tissue. • Improper connections of accessories may result in inadvertent accessory activation or other potentially hazardous conditions. • Connect adaptors and accessories to the electrosurgical unit only when the unit is off. Failure to do so may result in an injury or electrical shock to the patient or operating room personnel. • Start with the lowest possible power setting on the electrosurgical generator. To achieve the desired cutting and coagulation, check the patient circuit and then gradually increase the power setting. Note: The output power selected should be as low as possible for the intended purpose. • Do not activate the electrosurgical unit until the device has made contact with the patient. • Interference produced by the operation of HF surgical equipment may adversely influence the operation of other electronic equipment. • Use of low-frequency power could result in neuromuscular stimulation. • Failure of the electrosurgical generator may result in an unintended increase in output power. • No modification of this equipment is allowed. • Ensure the diameter of the trocar is compatible with the size of the shaft/scissors (5mm or 10mm). Failure to do so may compromise the instruments insulation. • Extended energized periods of time without contact to target tissue will increase the opportunity for insulation degradation.
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Cautions
• Always use the device in field of view of the camera and use caution when using other devices so as not to damage device insulation. • Smoke-plume extraction may be necessary during electrosurgical cutting or coagulation. • Snowden-Pencer devices should be handled and operated by health care professionals completely familiar with their use, assembly, and disassembly. • Use of these devices should be for their intended surgical purposes only. • Use of device for a task other than that for which it is intended can result in a damaged or broken device. • Device (including insulation) must be inspected prior to use to ensure integrity. Device accessories, such as electrode cables and endoscopically-used accessories should be checked for possible damage to the insulation prior to use. • Prior to use, all devices should be inspected for cracks, scratches, and/or broken components. Ensure insulation is intact. Any interruptions in the insulation may compromise the safety of the device. To prevent the possibility of electrical shocks or burns, devices with any interruption or cracks in the insulation or broken components should be returned to Snowden-Pencer for repair or replacement. • Do not use Snowden-Pencer devices if they do not perform satisfactorily or fail testing or visual inspection, which are detailed in the Inspection section of these instructions. • Avoid mechanical shock or overstressing the devices; this will cause damage. • The jaws must be completely closed prior to insertion or removal through cannulas. • Be sure the tips are closed and the instrument is pulled straight out until completely clear of the cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula. • Lateral pressure on the instrument during removal can damage the working tip, shaft of the device and/or insulation. • When used in conjunction with laser equipment, always use caution (i.e. eye protection). • Only the cleaning and sterilization processes, which are defined within these instructions for use, have been validated. • Not validated with ultrasonic cleaning processes. • Use only neutral pH (6-8) solutions for cleaning. Use of acidic or alkaline detergents can remove chromium oxide from the surface of stainless steel causing pitting or breakage of devices.
The following cautions are applicable only to electrosurgical devices listed in Appendix A: • To avoid eschar formation during use, clean the tips as needed utilizing a wet towel or sponge.
Rated Voltage
All Snowden-Pencer Modular products indicated for monopolar electrosurgical use are listed in Appendix A. The maximum recurring peak voltage for these devices is 1.5kVp. Note: the maximum recurring peak voltage for use with Single Use Sterile Scissors is 1.0kVp.
Activation Duration
All Snowden-Pencer Modular products indicated for monopolar electrosurgical use are listed in Appendix A. The recommended activation duration is 10 seconds on / 30 seconds off.
Instructions for Use
Note: Figures referenced are located on the first page of this instructions for use.
Component Familiarization
Refer to Figure 1 for all components of the modular device. Refer to Figures 2 and 3 with the following: (A) Ring handle (B) In-line handle (C) Pistol-grip handle (D) Shaft (E) Insert (F) Rotation knob (rotating versions only) (G) Electrosurgical Post (H) Thumb ring insert (I) Ratchet (ratcheted version only) (J) Ratchet release (ratcheted versions only) (K) Two assembly/release buttons (L) Handle lever (M) Flush port (N) Jaws
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Cleaning
Note: All reusable components (handle, shaft, and insert) must be cleaned and sterilized prior to use.
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Point of Use Processing
• Remove excess gross soil as soon as possible after use by wiping device while rinsing or immersing. • Transport devices via the institution’s established transport procedure. • Initiate cleaning of the device within 2 hours of use.
Cleaning – General Instructions
• All devices must be cleaned in the disassembled / taken apart configuration. Note that disassembly should not involve the use of any mechanical tooling (i.e. screwdriver, pliers, etc.). • All flush ports shall remain in the fully open position. • When using handles with SINGLE USE scissors, ensure the handle has been disassembled from the scissors. Discard the SINGLE USE portion according to your institution’s established procedures for medical waste disposal and all applicable local, state, federal, or country laws and regulations. • Thumb ring inserts in the reusable Snowden-Pencer Ergonomic Modular Ring Handles (SP94, SP95) must be separated from the handle prior to cleaning. • Devices may be cleaned by following either the Manual or Automatic Cleaning Instructions. • “Drinking/potable water” refers to water which meets the specifications for Utility Water listed in AAMI TIR34. • “Treated water” refers to water which meets the specifications for Critical Water listed in AAMI TIR34, and is extensively treated (for example by deionization, distillation, or reverse osmosis) to ensure that microorganisms and the inorganic and organic material are removed from the water.
Disassembly
Note: Figures referenced are located on the first page of this instructions for use. 1. Disable the ratchet (refer to Instrument Operation section). Ensure that the handle is fully open. (Figure 4) 2. For ring handles (SP94 and SP95), remove thumb ring insert from thumb ring. (Figure 4) 3. Press and hold both assembly/release buttons on the distal end of the handle. (Figure 5) 4. Remove the shaft and insert from the handle by pulling them away from the handle while keeping the buttons pressed. (Figure 5) 5. Turn the insert counter-clockwise relative to the shaft. (Figure 6) 6. Remove the insert from the shaft. (Figure 6) Refer to IFU (CF36-1833/26-2920) for disassembly instructions for the Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors.
Cleaning Instructions – Manual
1. Ensure all pre-processing and disassembly instructions are followed prior to cleaning. 2. Immerse all components in drinking/potable water with a temperature range of 27°C to 44°C (81°F to 111°F). Wipe components with a lint-free cloth to remove gross soil for at least 45 seconds. 3. Prepare an enzymatic/neutral pH detergent solution in a clean container, utilizing drinking/potable water with a temperature range of 27°C to 44°C (81°F to 111°F), per the detergent manufacturer’s instructions. 4. Place the handle in the open/relaxed position (Figure 4). Open the flush port on the shaft. Place the jaws in the open position. Immerse all components in the detergent solution and actuate all moveable parts. Soak components for a minimum of five (5) minutes. 5. Using a soft bristled brush, remove all visible soil from the entire device. Actuate the handle and jaws 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). 6. Using a soft bristled brush with a diameter of 3-6 mm (9-18 Fr) and length of at least 45 cm, thoroughly scrub the interior of the shaft.
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DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL
7. Position the shaft with the distal tip pointed down. Connect a syringe with a Luer lock to the flush port and flush with a minimum of 50 ml of detergent solution with a temperature range of 27°C to 44°C (81°F to 111°F) (Figure 7). Repeat the detergent flush process a minimum of three (3) times (i.e. total of 4 times), ensuring all fluid exiting the shaft is clear of soil. If visible soil is detected during the final detergent flush, repeat steps 6 and 7 until no visible soil is detected. 8. Place a syringe into the opening of the handle where the shaft is inserted and flush with a minimum of 50 ml of detergent solution with a temperature range of 27°C to 44°C (81°F to 111°F) (Figure 7). Repeat the detergent flush process a minimum of three (3) times (i.e. total of 4 times), ensuring all fluid exiting the device is clear of soil. If visible soil is detected during the final detergent flush, repeat steps 5 and 8 until no visible soil is detected. Note: Rinse steps (9 through 12) should be performed with treated water with a temperature range of 27°C to 44°C (81°F to 111°F). 9. Rinse the device by completely immersing all components in treated water for a minimum of 60 seconds. Actuate all moveable parts during immersion. 10.Position the shaft with the distal tip pointed down. Connect a syringe with a Luer lock to the flush port and flush with a minimum of 50 ml of treated water. (Figure 7) Repeat the flush process a minimum of three (3) times (i.e. total of 4 times). 11.Place a syringe into the opening of the handle where the shaft is inserted and flush with a minimum of 50 ml of treated water. (Figure 7) Repeat the flush process a minimum of three (3) times (i.e. total of 4 times). Note: The final rinse (step 12) should be performed in new treated water, not the same water utilized in rinse steps 9 through 11. 12.Perform a final rinse by completely immersing all components in treated water for a minimum of 30 seconds. Actuate all moveable parts during immersion. 13.Position the shaft with the distal end pointed down to allow rinse water to drain from the lumen. 14.Dry the device with a clean, lint-free towel. 15.Visually examine each device for cleanliness. 16.If visible soil remains, repeat the cleaning procedure until the device is thoroughly clean.
Cleaning Instructions – Automatic
1. Ensure all pre-processing and disassembly instructions are followed prior to cleaning. 2. Immerse all components in drinking/potable water with a temperature range of 27°C to 44°C (81°F to 111°F). Wipe components with a lint-free cloth to remove gross soil for at least 45 seconds. 3. Clean all components using the automatic cleaning parameters below. Note: Automatic washers with connections designed for flushing lumens should be connected to the flush port of each shaft. PHASE
MINIMUM RECIRCULATION TIME
WATER TEMPERATURE
DETERGENT TYPE AND CONCENTRATION (IF APPLICABLE)
Pre-Wash
15 Seconds
Cold Drinking/ Potable Water 1°C - 25°C (33°F - 77°F)
N/A
1 Minute
Hot Drinking/ Potable Water 43°C - 82°C (110°F - 179°F)
• Detergent: pH-neutral/ enzymatic • Concentration: Per the detergent manufacturer’s recommendations
2 Minutes
Hot Drinking/ Potable Water 43°C - 82°C (110°F - 179°F)
• Detergent: pH-neutral/ enzymatic • Concentration: Per the detergent manufacturer’s recommendations
Enzyme Wash
Wash
Hot Drinking/ Potable Water 43°C - 82°C (110°F - 179°F)
Rinse
15 Seconds
Pure Rinse
10 Seconds
Hot Treated Water 43°C - 82°C (110°F - 179°F)
N/A
Drying
N/A
N/A
N/A
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N/A
4. Position shafts with the distal end pointed down to allow rinse water to drain from the lumen. 5. If visible moisture is present, dry the instrument with a clean, lint-free towel. 6. Visually examine each instrument for cleanliness. 7. If visible soil remains, repeat the cleaning procedure until the device is thoroughly clean.
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Inspection
Proper care and handling is essential for satisfactory performance of any surgical device. The previously listed cautions should be taken to ensure long and trouble-free service. All devices must be examined for full functionality prior to and after use. Moving parts of the device should be easily operable. Inspect devices for broken, cracked, discolored, or tarnished surfaces. Inspect for hindered movement of hinges, loose components, and chipped or worn parts. Inspect insulation for breaks or damage. If any of these conditions appear, do not use the device. Return devices to an authorized Snowden-Pencer Representative for repair or replacement. Thumb Ring inserts (90-1111) are available for ring handles and should be replaced when worn or discolored. When disposing of or returning devices, products may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state, federal, or country laws and regulations.
Lubrication
• Before sterilizing, lubricate the device with instrument milk or a steam permeable/water soluble lubricant. A proper lubricant will leave a thin film and help the instrument move smoothly during use and maintain functionality over the lifetime of the instrument. • Instruments can be lubricated in either the assembled or disassembled / taken apart configuration. If the instruments are to be lubricated in the assembled configuration, perform the steps listed in the assembly instructions below before proceeding with lubrication. • Apply lubricant according to the lubricant manufacturer’s instructions. • Lubricant may be applied by an automatic cleaner if the cleaner has an option to apply lubricant after the final rinse. • Let devices drip dry for three (3) minutes before packaging for sterilization. • Immediately proceed to recommended steam sterilization. Do not store device prior to sterilization.
Sterilization General Instructions
• These devices may be sterilized in either the assembled or disassembled / taken apart configuration. If the instruments are to be sterilized in the assembled configuration but are currently disassembled, perform the steps listed in the assembly instructions below before proceeding with sterilization. • All devices must be processed in the completely open position (i.e. flush ports, jaws, etc.) to allow sterilant contact of all surfaces. • All devices shall be positioned so that water pooling does not occur.
DCN 45469 36-0151C 05NOV2020 David Knuth Vernon Hills, IL
Packaging
For United States Market: Use FDA-cleared sterilization wrap or sterilization container. • Use in accordance with packaging manufacturer’s sterilization instructions while being sure to protect jaws and cutting edges from damage. • Device configuration must meet the requirements of the packaging system. • Sterilization wrap material must be cleared for the applicable sterilization modality by your country’s regulatory body. • When utilizing a sterilization container, refer to container IFU for additional reprocessing instructions. Genesis™ containers support up to 16 instruments in a disassembled configuration.
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Prevacuum Steam Sterilization Parameters
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Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply) Temperature: 132°C (270°F) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes Sterilization Configuration: Containerized Temperature: 132°C (270°F) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes in chamber, 15 minutes in chamber post sterilization, 60 minutes on drying rack (may vary according to load content). Sterilization for Outside United States Market Prevacuum Steam Sterilization Parameters Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply) Minimum Preconditioning Pulses: 3 Temperature: 132°C (270°F) - 135°C (275°F) Exposure Time: 3-4 minutes Minimum Dry Time: 30 minutes Sterilization Configuration: Containerized Minimum Preconditioning Pulses: 3 Temperature: 132°C (270°F) - 135°C (275°F) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes in chamber, 15 minutes in chamber post sterilization, 60 minutes on drying rack (may vary according to load content).
Storage
After sterilization, devices should remain in sterilization packaging and be stored in a clean, dry environment.
Assembly
Note: Figures referenced are located on the first page of this instructions for use. 1. Slide insert fully into shaft. (Figure 8) 2. Lock insert to shaft by turning the insert clockwise until the line on the insert is aligned with the white line near Snowden-Pencer on the distal end of the shaft. (Figure 8) 3. Disable the ratchet (refer to Instrument Operation section). Ensure that the handle is fully open. (Figure 9) 4. Press and hold both assembly/release buttons on the front of the handle. (Figure 10) 5. With both buttons engaged, slide the assembled shaft and insert into the opening in the distal end of the handle until the flush port is slightly seated in the handle. (Figure 10) 6. Remove fingers from assembly/release buttons and fully insert the shaft until an audible click is heard. Note: When proper assembly is achieved, the assembly/release buttons will return to initial position and the jaws will open. 7. Verify that the jaws open and close when the handle is actuated. 8. For ring handles (SP94 and SP95), put thumb ring insert into thumb ring. Orient thumb ring insert as shown in Figure 11. Thumb ring inserts should push into and out of the thumb ring easily.
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Instrument Operation
• Compress and release the handle lever to close and open the jaws. • On rotating handles only (SP94, SP95, SP96, and SP98), the jaws may be rotated relative to the handle by turning the rotation knob. • Closing the handle with the ratchet enabled will cause it to engage and keep the handle and jaws closed. For ratcheted ring-handles (SP94): • Enable the ratchet by moving the ratchet release to the middle resting position. • Momentarily disengage the ratchet by pressing down on the ratchet release from the enabled position. • Disable the ratchet by flipping the ratchet release up. (Figure 4) For pistol-grip and in-line handles (SP96, SP97, SP98, and SP99): • Enable the ratchet by moving the ratchet release to the middle resting position. • Momentarily disengage the ratchet by sliding the ratchet release distally, allowing the handle to spring open. • Disable the ratchet by moving the ratchet release to the fully proximal position. (Figure 4)
Warranty
All Snowden-Pencer reusable devices are protected by a full service one (1) year warranty and lifetime warranty against manufacturer defects. Damage caused to the device by overstress, mechanical shock, improper processing, or repair by a party other than Snowden-Pencer is not covered. Repair, alteration or modification of any product by persons other than Snowden-Pencer, or products subjected to misuse or abuse will result in immediate loss of warranty. If Snowden-Pencer devices are damaged by accident or when used for a purpose other than originally intended, a repair charge will apply. IEC Classification for devices listed in Appendix A: BF Applied Part for non-continuous operation.
Repair Service
All device repairs must be returned to an authorized Snowden-Pencer Representative, to the address below or to an authorized representative for international repairs. If the repair is covered under warranty, it will be repaired or replaced at no charge when requested in writing. A nominal service charge will be made for repaired devices outside the warranty. Note: All devices being returned for maintenance, repair, etc. must be cleaned and sterilized per these instructions prior to shipment.
Contact Information
BD Customer Service 800-323-9088 For email inquiries: [email protected] www.bd.com For customers outside of the USA, please contact your local distributor. 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.
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Proofed by:______________________________ Date:_______________
Appendix A, Annexe A, Anhang A, Appendice A, Apéndice A, Anexo A, Bijlage A, Bilaga A, Bilag A, Liite A, Vedlegg A, Παράρτημα A, 付録 A, Příloha A, Dodatek A, Ek A, Anexa A, 부록 A SP83 SP95 SP8308 SP8314 SP8322 SP8327 SP8333 SP8343 SP8348 SP8354 SP8364 SP8373 SP8382 SP8387 SP8395 SP8407 SP8412 SP8421 SP8426 SP8432 SP8442 SP8447 SP8453 SP8463 SP8468 SP8481 SP8486 SP8494 SP8623 SP8629 SP8649 SP8654 SP8659 SP8722 SP8728 SP8738 SP8753 SP8758
SP84 SP8304 SP8309 SP8316 SP8323 SP8329 SP8335 SP8344 SP8349 SP8355 SP8365 SP8378 SP8383 SP8388 SP8396 SP8408 SP8414 SP8422 SP8427 SP8433 SP8443 SP8448 SP8454 SP8464 SP8473 SP8482 SP8487 SP8495 SP8624 SP8630 SP8650 SP8655 SP8660 SP8723 SP8729 SP8749 SP8754 SP8759
SP86 SP8305 SP8310 SP8318 SP8324 SP8330 SP8336 SP8345 SP8350 SP8356 SP8366 SP8379 SP8384 SP8391 SP8404 SP8409 SP8416 SP8423 SP8429 SP8435 SP8444 SP8449 SP8455 SP8465 SP8478 SP8483 SP8488 SP8496 SP8625 SP8631 SP8651 SP8656 SP8661 SP8724 SP8730 SP8750 SP8755 SP8760
SP87 SP8306 SP8311 SP8320 SP8325 SP8331 SP8341 SP8346 SP8351 SP8362 SP8367 SP8380 SP8385 SP8393 SP8405 SP8410 SP8418 SP8424 SP8430 SP8436 SP8445 SP8450 SP8456 SP8466 SP8479 SP8484 SP8491 SP8621 SP8626 SP8637 SP8652 SP8657 SP8692 SP8725 SP8731 SP8751 SP8756 SP8761
SP94 SP8307 SP8312 SP8321 SP8326 SP8332 SP8342 SP8347 SP8353 SP8363 SP8368 SP8381 SP8386 SP8394 SP8406 SP8411 SP8420 SP8425 SP8431 SP8441 SP8446 SP8451 SP8462 SP8467 SP8480 SP8485 SP8493 SP8622 SP8628 SP8638 SP8653 SP8658 SP8721 SP8726 SP8737 SP8752 SP8757 SP8792
Appendix B, Annexe B, Anhang B, Appendice B, Apéndice B, Anexo B, Bijlage B, Bilaga B, Bilag B, Liite B, Vedlegg B, Παράρτημα B, 付録 B, Příloha B, Dodatek B, Ek B, Anexa B, 부록 B SP96
SP97
SP98
SP99
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