Instructions for Use
68 Pages
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English DYONICS™ ELECTROBLADE™ Resector
Warnings Do not use if package is damaged. Do not use if the product sterilization barrier or its packaging is compromised.
Device Description The Smith & Nephew DYONICS™ ELECTROBLADE™ Resector combines the rotary cutting technology of Smith & Nephew Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. Insulation on the outer blade isolates the electrical energy to the inner blade where it is exposed to tissue at the cutting windows of the blade. The ELECTROBLADE Resector operates in conjunction with the Smith & Nephew DYONICS POWER II Shaver System and the Smith & Nephew VULCAN™ Generator system. The ELECTROBLADE Resector is a sterile and single-use device.
Indications for Use The Smith & Nephew DYONICS ELECTROBLADE Resector is indicated in arthroscopic surgical procedures of articular cavities for resection of and excision of soft and osseous tissues. Use in osseous tissues is limited to BONECUTTER™ ELECTROBLADE styles. The ELECTROBLADE Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solutions or Ringer’s lactate as an irrigant under direct or video-assisted fiber optic visualization.
Contraindications • Use of the resector is contraindicated in any non-arthroscopic surgical procedure and in procedures where saline or Ringer’s lactate is not used as an irrigant. • The resector is contraindicated in neurosurgery and cardiovascular surgery.
• Contents are sterile unless package is opened or damaged. DO NOT RESTERILIZE. For single use only. Discard any open, unused product. Do not use after the expiration date. • Attempts to reuse these devices can damage the insulative coating or cable resulting in harm to the patient or user. • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • Prior to use, read the Smith & Nephew DYONICS POWER II Operations/ Service Manual (REF 10600181), the DYONICS Handpieces Instructions for Use (REF 10600266), the VULCAN™ Generator Operations/Service Manual (REF 1061526), the generator manufacturer’s operations manual, and any associated equipment operations manuals for system setup, operation, and cleaning instructions. • For VULCAN Generators Only: Ensure that the software version indicated on the generator display is version 3.60 or greater. If not, do not use the ELECTROBLADE Resector. Contact a Smith & Nephew representative. Use the Smith & Nephew ELECTROBLADE Adaptor (REF 7210380) to connect selected resector products, as indicated in Tables 1 and 2 of these Instructions for Use, to the VULCAN Generator. • Do not touch the open window area at the tip of the resector when power from the electrosurgical generator is being applied. Electrical injury can result.
• The resector is contraindicated for use with generators not indicated in these Instructions for Use.
• Do not activate the resector when the tip is in contact with or in close proximity to a metal cannula. Arcing to a metal cannula can cause a patient burn.
• The resector is not appropriate for patients for whom an arthroscopic procedure is contraindicated for any reason.
• Do not withdraw the resector while power from the electrosurgical generator is being applied.
• Use of the resector is contraindicated in patients with heart pacemakers or other electronic device implants.
• Do not lay any electrosurgical instrument on the patient or drapes. If another electrosurgical instrument of any type, whether foot or hand controlled, is activated both devices will be activated and can result in patient burns.
• The resector should not be used in patients exhibiting ankylosis, without adequate joint space or distention for arthroscopic inspection. Abrasion arthroplasty may not be effective in treating heavy patients or those with ankylosis, instability, or expectations beyond the relief of pain. • Intracortical abrasion arthroplasty may be contraindicated in patients not qualifying for high tibial osteotomy or total knee replacement. • Synovectomy is contraindicated when disease has progressed beyond the phase of synovial proliferation, and advanced rheumatoid arthritis when erosion of the articular cartilage is present.
• Failure of the radiofrequency (RF) surgical equipment can result in an unintended increase in power output. • During RF activation, use arthroscopic visualization to ensure that suction is on and the resector tip and the uninsulated tube return are completely surrounded by irrigant solution. • Ensure that there is an uninterrupted flow of irrigant through the resector to maintain safe fluid temperature in the joint space. Ensure that suction of 128 mmHg minimum is flowing while the instrument is running. • If irrigant flow is insufficient, heating of the irrigant within the joint can occur, which can cause patient burns as the irrigant exits one of the arthroscopic portals. • Avoid bubble accumulation in the joint space during use. The accumulation of bubbles around the working tip of the resector will diminish performance and can produce overheating sufficient to damage surrounding tissue. • Do not use COAG when resecting close to the skin or the portal site as it can result in patient burns. • Keep the power as low as possible to achieve the desired coagulation effect. Refer to the power settings located in Tables 1 and 2. • If the surgeon increases the power settings, the surgeon should also increase the irrigant flow through the joint to maintain a safe fluid temperature. • Do not wrap the cables around metal objects. Wrapping the cable around metal objects can induce currents that could lead to shock, fires, or injury to the patient or surgical personnel.
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1061322 Rev. F
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
English • Apply RF activation of the resector in brief intervals to minimize the potential for collateral tissue damage associated with the use of RF energy. The use of the resector should coincide with the RF duty cycle specified in the VULCAN™ Generator Operations/Service Manual or the appropriate generator manufacturer’s operations manual.
• These devices meet the requirements of IEC 60601-2-2:2006 (4th Edition) and IEC 60601-2-2:2009 (5th Edition) with the VULCAN Generator. • Resectors can withstand a maximum allowable peak voltage of 535V. • Do not use a neutral electrode with the resector.
• As with all electrosurgical devices, do not use in the presence of flammable anesthetics or oxidizing gases, such as nitrous oxide or oxygen. An electrosurgical device has the potential for providing a source for ignition. Endogenous gases, which accumulate in body cavities, can also be a source of ignition.
• After use, this device can be a potential biohazard; handle in accordance with accepted medical practice and applicable local and national requirements.
• The electrode tip can remain hot enough to cause burns after the electrosurgical current is deactivated.
• With VALLEYLABT Generators, only use the 4.5 mm ELECTROBLADE Resectors (See Tables 1 and 2 for additional information). Do not use the 5.5 mm BONECUTTER™ ELECTROBLADE Resector with VALLEYLAB Generators.
• Do not allow the patient to come into contact with metal parts which are grounded or which have appreciable capacitance to ground (i.e., operating table supports). Use anti-static sheeting for this purpose.
• Use the ERBE Bipolar Adaptor (REF 20183-022), the BOWA-electronic Bipolar Adaptor (REF 340-000), or equivalent adaptor to connect the ELECTROBLADE Resector to the ERBE Generators.
• When RF surgical equipment and physiological monitoring equipment are used simultaneously on the patient, place any monitoring electrodes as far as possible from the surgical electrodes. • Position the cables to the surgical electrodes in such a way that contact with the patient or other leads are avoided. • Only activate the resector when at the target tissue site. • Do not use this device in oxygen rich environments (>25%). • The recommended system configuration included in these instructions complies with IEC 60601-1-1:2000 (2nd Edition) and IEC 60601-1:2005 (3rd Edition) requirements. If a different configuration is used, test the system to the applicable standard. If the leakage current of the configured system exceeds the limits of IEC 60601-1-1:2000 (2nd Edition) or IEC 60601-1:2005 (3rd Edition), install an appropriately rated and approved isolation transformer and retest the system.
Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Hazards associated with reuse of this device include, but are not limited to, patient infection and/or device malfunction. • Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged device. • The ELECTROBLADE™ Resector is preassembled, packaged sterile, and ready for use. Any attempt to disassemble the resector cables will damage them and make them unusable. • Use only saline or Ringer’s lactate with this device. Do not use non-conductive irrigants (e.g., sterile water, air, gas, glycine, etc.). • Do not allow the resector to come in contact with metal objects when activated as this can damage the shaver resector tip. • Activation of an electrosurgical device when not in contact with target tissue or in position to deliver energy to target tissue can cause capacitive coupling. • The interference produced by the operation of RF surgical equipment can adversely influence the operation of other electronic equipment. • Ensure that the cable from the resector is fully seated into the electrosurgical generator or ELECTROBLADE Adaptor. Do not allow fluid to contact the end of the cable that attaches to the electrosurgical generator or adaptor. • Direct contact of the rotating resecting edge of the resector with metal (e.g., cannula, arthroscope, or other instrument) can cause damage to both instruments. • Excessive “side loading” on the resector during use does not improve resection performance and, in extreme cases, can result in wear and degradation of the inner resector. • Avoid scraping the resector against hard surfaces as it can damage the resector’s insulation. • Inspect electrode cables and coated surfaces for possible damage of insulation.
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
1061322 Rev. F
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English System Configurations CAUTION: ELECTROBLADE™ Resectors can withstand a maximum allowable peak voltage of 535V.
Recommended System Configuration Figure 1 indicates a system configuration that complies with IEC 60601-1-1:2000 (2nd Edition) and IEC 60601-1:2005 (3rd Edition) requirements. Note: The ELECTROBLADE™ Adaptor (REF 7210380) is utilized in the system configuration to connect some ELECTROBLADE Resectors to the VULCAN™ Generator. See Tables 1 and 2 for additional information.
WARNING: The recommended system configuration included in these instructions complies with IEC 60601-1-1:2000 (2nd Edition) and IEC 60601-1:2005 (3rd Edition) requirements. If a different configuration is used, test the system to the applicable standard. If the leakage current of the configured system exceeds the limits of IEC 60601-1-1:2000 (2nd Edition) or IEC 60601-1:2005 (3rd Edition) , install an appropriately rated and approved isolation transformer and retest the system. The use of accessory equipment not complying with the equivalent safety requirements of this equipment can lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • Use of the accessory in the patient vicinity. • Evidence that the safety certification of the accessory has been performed in accordance with the applicable standard.
Control
Figure 1. Recommended System Configuration
Other System Configurations The ELECTROBLADE Resector is compatible with the following electrosurgical generators: VALLEYLABT Force FXT, VALLEYLAB Force FX-C, VALLEYLAB Force 2 (4.5 mm ELECTROBLADE Resectors only); ERBE ERBOTOM ICC 350, and ERBE ERBOTOM ICC 300 E and H per IEC 60601-1-1:2000 (2nd Edition).
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1061322 Rev. F
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
English Instructions for Use Connect the ELECTROBLADE™ Resector to the Handpiece 1. Set up the electrosurgical generator according to the manufacturer’s operations manual. 2. Set up the DYONICS™ POWER II Shaver System per the Operations/Service Manual. 3. Remove the resector from the sterile package by peeling the Tyvek® seal off the resector tray taking care to maintain sterility. 4. Remove the protective tubing from the resector. WARNING: Do not use if package is damaged. Do not use if the product sterilization barrier or its packaging is compromised. CAUTION: Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged device. 5. Attach the selected resector to the shaver handpiece hub. Push the resector proximally as far as possible to ensure a positive lock (Figure 2).
• Apply RF activation of the resector in brief intervals to minimize the potential for collateral tissue damage associated with the use of RF energy. The use of the resector should coincide with the RF duty cycle specified in the VULCAN Generator Operations/Service Manual or the appropriate generator manufacturer’s operations manual.
Using ELECTROBLADE Resectors and the ELECTROBLADE Adaptor with the VULCAN™ Generator 1. Connect the adaptor to the VULCAN Generator. For instructions, see the adaptor Instructions for Use (REF 1061482). 2. Insert the resector connector cable securely into the 2-pin socket on the adaptor. Hold the adaptor securely when inserting the connector cable into the adaptor. 3. Turn the generator on and set to the appropriate bipolar setting. Adjust the power settings as recommended in Table 1 for coagulation only and Table 2 for simultaneous mechanical resection and coagulation. 4. Activate the generator by depressing the blue COAG pedal on the footswitch. Note: The yellow CUT pedal on the footswitch is deactivated when using the resector with the generator. 5. For coagulation only, stop the resector in the three-quarters closed position and activate the RF mode per the recommended setting in Table 1. 6. To achieve simultaneous mechanical resection and coagulation, depress the electrosurgical generator footswitch to activate RF to the resector during mechanical resection. Refer to Table 2 for generator power settings. For the best results for simultaneous resection and coagulation, use the following sequence: a. Activate the electrosurgical generator by depressing the footswitch. Maintain electrosurgical generator activation throughout the resection procedure. b. Turn the handpiece on and resect tissue as required.
Figure 2. Attach resector to shaver handpiece
6. Set up the Blade Window Lock using one of the following methods so that the inner resector rotates until the resecting window is sufficiently open to ensure flow. • Depress and hold the “WINDOW LOCK” button on the control unit or footswitch to set the window lock. • To set up Blade Window Lock for coagulation only, use the three-quarters closed position. • If using a handpiece with hand controls, depress and hold the “OSCILLATE” button to set the window lock.
Connect the ELECTROBLADE Resector to a Generator and Activate RF Refer to Tables 1 and 2 for recommended power settings and to determine which resectors can be utilized with each of the electrosurgical generators.
c. Turn the handpiece off. d. Deactivate the RF mode by releasing the footswitch. e. Continue the flow of irrigant for several seconds after RF has been discontinued to maintain safe fluid temperature in the joint space. 7. To remove the resector during surgery, ensure that the power is not being applied to the resector and carefully remove it from the joint cavity, under visualization.
Using 4.5 mm ELECTROBLADE Resectors with the VULCAN Generator 1. Plug the 4.5 mm resector cable into the 8-pin connector on the generator while the generator is off. 2. Turn the generator on and set to the appropriate bipolar setting. Adjust the power settings as recommended in Table 1 for coagulation only and Table 2 for simultaneous mechanical resection and coagulation. 3. Depress the blue COAG pedal on the footswitch to activate the generator. Note: The yellow CUT pedal on the footswitch is deactivated when using the resector with the generator.
Warnings • During RF activation, use arthroscopic visualization to ensure that suction is on and the resector tip and the uninsulated tube return are completely surrounded by irrigant solution. • Ensure that there is an uninterrupted flow of irrigant through the resector to maintain safe fluid temperature in the joint space. Ensure that suction of 128 mmHg minimum is flowing while the instrument is running. • If irrigant flow is insufficient, heating of the irrigant within the joint can occur, which can cause patient burns as the irrigant exits one of the arthroscopic portals.
4. For coagulation only, stop the resector in the three-quarters closed position and activate the RF mode per the recommended setting in Table 1. 5. To achieve simultaneous mechanical resection and coagulation, depress the electrosurgical generator footswitch to activate RF to the resector during mechanical resection. Refer to Table 2 for generator power settings. For the best results for simultaneous resection and coagulation, the sequence of operation is as follows: a. Activate the electrosurgical generator by depressing the footswitch. Maintain electrosurgical generator activation throughout the resection procedure.
• Do not use COAG when resecting close to the skin or the portal site as it can result in patient burns.
b. Turn the handpiece on and resect tissue as required.
• Keep the power as low as possible to achieve the desired coagulation effect. Refer to the power settings located in Tables 1 and 2.
d. Deactivate the RF mode by releasing the footswitch.
• If the surgeon increases the power settings, the surgeon should also increase the irrigant flow through the joint to maintain a safe fluid temperature.
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
c. Turn the handpiece off. e. Continue the flow of irrigant for several seconds after RF has been discontinued to maintain safe fluid temperature in the joint space. 6. To remove the resector during surgery, ensure that the power is not being applied to the resector and carefully remove it from the joint cavity, under visualization.
1061322 Rev. F
5
English Using ELECTROBLADE™ Resectors with the VALLEYLABT or ERBE Generators WARNING: Prior to use, read the generator manufacturer’s operations manual, and any associated equipment operations manuals for system setup, operation, and cleaning instructions. CAUTION: With VALLEYLAB Generators, only use the 4.5 mm resectors (See Tables 1 and 2 for more information). Do not use the 5.5 mm BONECUTTER™ resector with VALLEYLAB Generators.
Warranty For single use only. This product is warranted to be free from defects in material and workmanship. Do not reuse.
For Further Information If further information on this product is needed, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized representative.
Note: VALLEYLAB Generators require a bipolar footswitch for operation. 1. Verify that the generator is off. 2. ERBE only: Connect the ERBE or BOWA-electronic bipolar adaptor to the generator by inserting it into the bipolar connector. 3. ERBE only: Plug the resector cable into the ERBE or BOWA-electronic bipolar adaptor. 4. VALLEYLAB only: Plug the 4.5 mm resector cable into the bipolar connector of the generator. 5. Turn the generator on and set to the appropriate bipolar setting. Adjust the power settings as recommended in Table 1 for coagulation only and Table 2 for simultaneous mechanical resection and coagulation. 6. Depress the footswitch to activate the generator. ERBE only: If there is a dual-pedal footswitch, depress the blue foot pedal. 7. For coagulation only, stop the resector in the three-quarters closed position and activate the RF mode per the recommended setting in Table 1. 8. To achieve simultaneous mechanical resection and coagulation, depress the electrosurgical generator footswitch to activate RF to the resector during mechanical resection. Refer to Table 2 for generator power settings. For the best results for simultaneous resection and coagulation, the sequence of operation is as follows: a. Activate the electrosurgical generator by depressing the footswitch. Maintain electrosurgical generator activation throughout the resection procedure. b. Turn the handpiece on and resect tissue as required. c. Turn the handpiece off. d. Deactivate the RF mode by releasing the footswitch. e. Continue the flow of irrigant for several seconds after RF has been discontinued to maintain safe fluid temperature in the joint space. 9. To remove the resector during surgery, ensure that the power is not being applied to the resector and carefully remove it from the joint cavity, under visualization.
Postoperative Steps 1. After surgery, turn the generator and the shaver system off. 2. Disengage the resector connector cable from the generator or adaptor. 3. When using the resector with the adaptor, hold the adaptor securely and disengage the resector connector cable from the 2-pin socket on the adaptor. 4. To remove the resector from the handpiece, depress the key on the resector with a thumb or fingertip. This disengages the resector hub from the driveshaft. Withdraw the resector from the handpiece. 5. Dispose of the single use resector according to hospital protocol. Note: The adaptor is a reusable accessory and may remain attached to the bracket on the side of the VULCAN Generator when not in use, or may be stored in a clean, dry area.
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1061322 Rev. F
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
English Table 1. Recommended settings for coagulation only with the resector stopped in the three-quarter closed position, RF activated (non-simultaneous activation).*
ELECTROBLADE™ Resector REF
ELECTROBLADE Description
Generator Manufacturer and Model
Generator Mode
Generator Setting (WATTS)
7209855 7209983
4.5 mm Full Radius/ ELITE™ 4.5 mm Full Radius
Smith & Nephew VULCAN™ Generator
BIPOLAR COAG
70–100
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER ™ 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
Smith & Nephew VULCAN Generator with ELECTROBLADE Adaptor
BIPOLAR COAG
70–100
7205962
BONECUTTER 5.5 mm Full Radius
Smith & Nephew VULCAN Generator with ELECTROBLADE Adaptor
BIPOLAR COAG
80–100
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
VALLEYLABT Force FXT or FX-C
Precise, Standard, or Macro
50–70
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
VALLEYLAB Force 2
MICROBIPOLAR
50–70
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
ERBE ERBOTOM ICC 350 or ERBOTOM ICC 300 E and H
AUS OFF mode of AUTO BIPOLAR function field
70–100
7205962
BONECUTTER 5.5 mm Full Radius
ERBE ERBOTOM ICC 350 or ERBOTOM ICC 300 E and H
AUS OFF mode of AUTO BIPOLAR function field
80–100
Table 2. Recommended settings for simultaneous mechanical resection and coagulation.* ELECTROBLADE Resector REF
ELECTROBLADE Description
Generator Manufacturer and Model
Generator Mode
Generator Setting (WATTS)
7209855 7209983
4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
Smith & Nephew VULCAN Generator
BIPOLAR COAG
80–100
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
Smith & Nephew VULCAN Generator with ELECTROBLADE Adaptor
BIPOLAR COAG
80–100
7205962
BONECUTTER 5.5 mm Full Radius
Smith & Nephew VULCAN Generator with ELECTROBLADE Adaptor
BIPOLAR COAG
90–110
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
VALLEYLAB Force FX or FX-C
Precise, Standard, or Macro
50–70
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
VALLEYLAB Force 2
MICROBIPOLAR
50–70
7205961 72202213 7209700
4.5 mm Full Radius/ BONECUTTER 4.5 mm Full Radius/ ELITE 4.5 mm Full Radius
ERBE ERBOTOM ICC 350 or ERBOTOM ICC 300 E and H
AUS OFF mode of AUTO BIPOLAR function field
80–100
7205962
BONECUTTER 5.5 mm Full Radius
ERBE ERBOTOM ICC 350 or ERBOTOM ICC 300 E and H
AUS OFF mode of AUTO BIPOLAR function field
90–110
* Prior to use, refer to the generator’s operations manual for instructions .
™Trademarks of Smith & Nephew, certain marks registered U.S. Patent & Trademark Office. All trademarks acknowledged. Covered by one or more of the following U.S. Patent Numbers: 5,510,070; 5,563,481; 5,602,449; 5,620,447; 5,630,826; 5,672,945; 5,712,543; 5,745,647; 5,749,885; 5,804,936; 5,833,692; 5,871,493; 5,913,867; 6,090,122; 6,328,752; 7,150,747; other patents pending.
DYONICS™ ELECTROBLADE™ Resector
Instructions for Use
1061322 Rev. F
7
Follow instructions for use • Gebrauchsanweisung befolgen • Siga el Modo de empleo • Suivre le mode d’emploi • Seguire le istruzioni per l’uso • Följ bruksanvisningen • Volg de gebruiksaanwijzing • Seguir as instruções de utilização • Følg brugsanvisningen • Følg bruksanvisningen • 사용 지침을 따르십시오 Lot number • Chargennummer • N° de lote • N° de lot • Numero di lotto • Lot-nummer • Lotnummer • Número de lote • Lotnummer • Partinummer • 제조 일련번호 Catalogue Number • Katalognummer • Número de catálogo • Numéro de catalogue • Numero di catalogo • Katalognummer • Bestelnummer • Número de catálogo • Katalognummer • Katalognummer • 카탈로그 번호 Single Use Only. Do Not Reuse • Nur für einmaligen Gebrauch. Nicht wieder verwenden • Para usar una sola vez. No reutilizar • À usage unique. Ne pas réutiliser • Monouso. Non riutilizzare • Endast för engångsbruk. Får ej återanvändas • Uitsluitend voor eenmalig gebruik. Niet nogmaals gebruiken • Apenas para utilização única. Não reutilize • Kun til engangsbrug. Må ikke genanvendes • Bare til engangsbruk. Må ikke brukes om igjen • 일회 사용으로 제한. 재사용하지 마십시오 Sterile, Ethylene Oxide • Mit Ethylenoxid sterilisiert • Estéril, óxido de etileno • Stérilisé à l’oxyde d’éthylène • Sterilizzazione mediante ossido di etilene • Steril, etylenoxid • Steriel, ethyleenoxide • Esterilizado, Óxido de etileno • Steril, ethylenoxid • Steril, etylenoksid • 산화 에틸렌 멸균 Date of Manufacture • Herstellungsdatum • Fecha de fabricación • Date de fabrication • Data di fabbricazione • Tillverkningsdatum • Fabricagedatum • Data de fabrico • Fremstillingsdato • Produksjonsdato • 제조일자 Use by • Verwenden bis • Fecha de caducidad • Utiliser avant le • Utilizzare entro il • Används före • Te gebruiken vóór • Validade • Anvendes inden • Brukes innen • 사용 기한
CE mark • CE-zeichen • Marca CE • Marque CE • Marchio CE • CE-märkning • CE-markering • Marca CE • CE-mærke • CE-merke • CE 마크
Manufacturer • Hersteller • Fabricante • Fabricant • Produttore • Tillverkare • Fabrikant • Fabricante • Producent • Produsent • 제조업체
European Representative • Europa-Vertretung • Representante europeo • Représentant pour l’Europe • Rappresentante europeo • Representant i Europa • Vertegenwoordiger in de EU • Representante na Europa • Europæisk repræsentant • Europeisk representant • 유럽 대리점
Smith & Nephew York Science Park Heslington, York YO10 5DF United Kingdom
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
™Trademarks of Smith & Nephew. Certain marks registered U.S. Patent & Trademark Office. All trademarks acknowledged. www.smith-nephew.com +1 978 749 1000 +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service
©2003, 2012 Smith & Nephew, Inc. All rights reserved. 06/2012 1061322 Rev. F