Telescopes

II Telescopes

Instruction Manual

HOPKINS ®

HOPKINS ®

Important information forusers of KARL STORZinstrumentsThank you for placing confidence in thename of KARL STORZ. As with all our otherproducts, we have invested years of expe-rience and much care in production of thistelescope. You, and your organization,have chosen a modern high-quality KARLSTORZ instrument.These instructions are designed to assistyou in cleaning, sterilizing, disinfecting,caring for and storing your KARL STORZtelescopes. Please read them carefully.CAUTION: Federal (USA) law restricts thisdevice to sale by or on the order of a physician.

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Illustrated Description

Specifications:Letter code Direction of ViewA 0˚-10˚ Straight ForwardB 30˚ Forward-ObliqueC 70˚ LateralD 90˚ LateralE 120˚ RetrospectiveF 45˚W 30˚ Wide AngleFA 12˚ TelescopesKARL STORZ HOPKINS® and HOPKINS® IITelescopes are provided both auto-clavable and non-autoclavable. Toidentify the difference please note“AUTOCLAV” marked on the eyepiece.

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ContentsIllustrative Description ..............................4Important Information ...............................6General Information for the Safe Useof KARL STORZ Telescopes ....................7Inspection .................................................9Handling .................................................11Operating Instructions ............................11Cleaning, Disinfection and Sterilization..12Cleaning Instructions..............................13Disinfection Instructions .........................15Sterilization Instructions..........................18References for Cleaning and Sterilization ......................................23Inspection, Maintenance and Repair &Return Policy...........................................24Warranty Policy.......................................27Limitation of Liability ...............................28Appendix I ..............................................31

A. Indications and Contraindicationsfor Urology ....................................30

B. Indications for General Surgery ...30C. Indications for Thoracoscopy.......30D. Indications for Ear, Noseand Throat ....................................31

E. Indications for Arthroscopy ..........31F. Indications for Plastic Surgery......31G.Indications and Contraindicationsfor Gynecology .............................32

H. Indications and ContraindicationsDiagnostic Hysterscopy ...............33

I. Indications and ContraindicationsOperative Hysterscopy.................34

J. Indications & Contraindicationsfor Neurology ................................36

K. Indications & Contraindications for Dentistry ..................................37

Appendix II .............................................38A.Cleaning Accessories...................38

Quick Reference.....................................395

Important Information for usersof KARL STORZ instrumentsIMPORTANTPlease read this entire manual carefullybefore using KARL STORZ HOPKINS® andHOPKINS® II Telescopes. Failure to followthe instructions, cautions and warningspresented in this manual may result in seri-ous consequences to the patient.The procedures for proper handling and careof KARL STORZ HOPKINS® and HOPKINS® IITelescopes are described in this manual.The KARL STORZHOPKINS® and HOPKINS®

II Telescopes are delicate optical instrumentsand should be handled with care. Improperuse during surgical procedures will result indamage or breakage of the telescope. KARLSTORZ Endoscopy-America, Inc. assumesno liability if the telescopes are misused,mishandled or otherwise abused. Properhandling and care, as described in this man-ual, will prolong the life of the KARL STORZHOPKINS® and HOPKINS® II Tele scopes.Recommended procedures for inspectingand preparing the telescopes for use aredescribed in this manual. The manual doesnot describe how the actual procedure is tobe performed. Endoscopic proceduresshould be performed only by physicians whohave training in endoscopic techniques.Consult medical literature relative to tech-niques, complications and hazards ofendoscopic procedures.A thorough understanding of the principlesand techniques involved in endoscopicand electrosurgical procedures is essentialto avoid shock and burn hazards to boththe patient and physician.The KARL STORZ HOPKINS® and HOPKINS®

II Telescopes are compatible with any lightsources and light cables marketed byKARL STORZ Endoscopy America, Inc.CAUTION: The KARL STORZ HOPKINS®

and HOPKINS® II Telescopes are providedNON-STERILE, and must be cleaned, disin-fected and/or sterilized prior to the initialuse and before each subsequent use.

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General Information for theSafe Use of KARL STORZTelescopes

User qualificationsThese instruments may only be used bylicensed physicians and qualified medicalpersonnel who have been trained in their use.

Warnings and precautionsPlease read this manual carefully. It is veryimportant that the user be thoroughly familiarwith the operation of the instrument prior touse on a patient. The terms “Warning,”“Caution” and “Note” are intended to drawyour attention to important parts of theinstruction manual. All warnings, precautionsand notes should be thoroughly reviewedprior to use of the instrument. Close attentionto all warnings, precautions and notes isnecessary for safe and effective operationof the device.

DefinitionsWARNING: A warning indicates that thepersonal safety of the patient or physicianmay be compromised. Disregarding thewarning may result in serious injury to thepatient or the physician.Caution: A caution indicates that thedevice may be damaged if the caution isdisregarded.Note: A note provides additional informationregarding the safe operation of the device.

Description of DeviceThe KARL STORZ HOPKINS® and HOPKINS®

II telescopes are reusable rod lens endo-scopes consisting of an eyepiece lens, alight post connection for fiber optic lightcables with screw-on adapters which willaccommodate light cables from othermanufacturers.

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General Information for the SafeUse of KARL STORZ Telescopes(Continued)

A shaft made of non-corrosive materialencloses the rod-lens system and a built-infiber optic light carrier. See page 4 for iden-tification of parts.

IndicationsKARL STORZ HOPKINS® and HOPKINS® IItelescopes are to be used for visualizationof the surgical site during diagnostic andtherapeutic endoscopic procedures. SeeAppendix I for specific indications for use.

ContraindicationsKARL STORZ HOPKINS® and HOPKINS® IItelescopes are contraindicated for usewhen, in the opinion of a qualified physician,such use would create a condition thatwould be dangerous for the patient. SeeAppendix I for specific contraindications.WARNING: KARL STORZ HOPKINS® andHOPKINS® II telescopes are provided NON-STERILE and must be thoroughly cleanedand sterilized according to validated infectioncontrol procedures prior to use and subse-quent reuse.WARNING: High level disinfection is recom-mended ONLY for telescopes which comeinto contact with intact mucous membranesor minor skin breaches. Disinfection is NOTrecommended for telescopes to be used forlaparoscopic, arthroscopic, hysteroscopic,Ob/Gyn, plastic, reconstructive, aesthetic, orneurology surgery procedures.WARNING: Always adjust the light sourceto the minimum illumination intensity neces-sary to achieve optimum illumination of theendoscopic scene, either by direct vision orcoupled to a video camera. The higher thelight intensity setting of the light source, thegreater the heat energy that will be gener-ated at the distal end of the telescope.

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WARNING: Never place the end of a fiberoptic cable or telescope connected to alight cable on or under a surgical drapewhile the light source is activated. Theintensity of the light may cause burns to thepatient and/or the surgical drape. Turn thelight source to standby or initial mode whenthe telescope is not in use. Never attachcable or cable connector to patient or drape.WARNING: Do not use telescopes withvisible signs of damage.Caution: Steam sterilize only KARL STORZtelescopes marked 'AUTOCLAV'! Non-auto-clavable telescopes will suffer irreparabledamage.Caution: Do not use Immediate-Use Steam(FLASH) sterilization for any KARL STORZHOPKINS® or HOPKINS® II telescopes.

InspectionInspection of the HOPKINS® andHOPKINS® II Telescopes: Inspection ofthe KARL STORZ HOPKINS® and HOPKINS®

II Tele scopes for signs of damage should beperformed before and after every surgicalprocedure.

Working ShaftInspect the entire surface of the working shaftof the telescope for any signs of damage suchas dents, bends or scratches.

Objective lens and EyepieceInspect the objective lens (distal tip) and eye-piece for scratches, chips, fingerprints orresidual debris by observing the reflectedlight on the surfaces of the eyepiece andobjective lens. These surfaces should besmooth and shiny. To check for clarity of viewslowly rotate the telescope while lookingthrough the eyepiece. A partially or completelyobstructed view may be the result of a damagedlens within the eyepiece or within the telescopeshaft. Foggy images may result from moistureentering a damaged seal around the lens.

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Inspection (Continued)

CAUTION: Do not use telescopes if signs ofdamage are present.CAUTION: The telescope must be replacedif the image is clouded, distorted or there isno image.CAUTION: The telescopes are providedNON-STERILE and must be cleaned, disin-fected and/or sterilized prior to initial use andsubsequent reuse.CAUTION: Steam sterilize only KARLSTORZ telescopes marked 'AUTOCLAV'!Non-autoclavable telescopes will sufferirreparable damage. CAUTION: Do not use Immediate-Use Steam(FLASH) sterilization for any KARL STORZ HOP-KINS® and HOPKINS® II telescopes.If there is any doubt about whether the tele -scopes are safe to use, please contact yoursales representative or the Technical Sup portStaff directly at KSEA (1-800-421-0837).

Handling of HOPKINS® andHOPKINS® II Telescopes

KARL STORZ HOPKINS® and HOPKINS® IITelescopes are delicate instruments. Toensure the long lasting quality of the telescope,please follow the handling instructionsdescribed below.1. To prevent breakage, telescopes should

be supported by firmly grasping the eye-piece end. Never handle the telescope bythe distal end alone.

2. Never bend the stainless steel shaft. Thiscould lead to breaks or cracks in the rod-lens system.

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3. Handle the telescope with care.Mishandling of the telescope, particularlyat the distal end, may result in damage orcracks in the telescope. Damage to thetelescope may allow liquid and othermaterials to penetrate causing unclearimages.

4. When cleaning, disinfecting and sterilizingtelescopes, KARL STORZ recommendsthat they be handled separately fromother instruments.

5. Protective cases, which are suitable forstorage, transport and sterilization, areavailable in various lengths for KARLSTORZ HOPKINS® and HOPKINS® IITelescopes.

Operating Instructions1. Be sure that the telescopes have been

properly cleaned, disinfected and/or ster-ilized prior to use. (See Cleaning,Disinfection and Sterilization section fordetailed procedures).

2. Inspect the telescope for damage andproper function as described above.

3. Operate all video and light source equip-ment in accordance with manufacturer’sinstructions.

WARNING: Always adjust the light source tothe minimum illumination intensity necessaryto achieve optimum illumination of the endo-scopic scene, either by direct vision or coupledto a video camera. The higher the light intensitysetting of the light source, the greater the heatenergy that will be generated at the distal endof the telescope.WARNING: Never place the end of a fiberoptic light cable or a telescope connected toa light cable on or under a surgical drapewhile the light source is activated. The inten-sity of the light may cause burns to the patientand/or the surgical drape. Turn the light sourceto standby or initial mode when the telescopeis not in use.

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4. Prepare the surgery entry site in accor-dance with proper endoscopic surgicaltechniques. Consult the appropriate med-ical literature.

5. Attach the light cable to the fiber opticlight post on the telescope. KARL STORZrecommends that the appropriate sizelight cable be used to minimize the heatenergy generated from the light source.Use of the appropriate size light cable willreduce the risk of patient burns, as well asthe risk of igniting flammable material.Telescope Diameter Light Cable Diameter

4.0 mm and less 2.5 mm

6.0 mm and less 3.5 mm

Larger then 6.0 mm 4.8 mm

Cleaning , Disinfection andSterilization InstructionsWARNING: The KARL STORZHOPKINS®

and HOPKINS® II Telescopes shouldbe thoroughly cleaned, disinfectedand/or sterilized according to validatedinfection control procedures prior touse and subsequent reuse.CAUTION: DO NOT soak the telescope inany solution (including water) for longer than60 minutes.

Preparation for Cleaning andSterilization1. Disconnect the light cable from the tele-

scope.2. Remove the light cable adapters.

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3. Place telescope in a plastic container andsoak with a neutral pH (pH 6.0 to 8.0)enzymatic cleaning solution (e.g., Enzol,Metrizyme or the equivalent diluted toproper concentration per manufacturer’sinstructions) immediately after use to pre-vent blood, protein and other contami-nants from drying onto the telescope. Donot soak telescopes with other instrumentsto prevent damage to the telescope.

Water Quality RequirementsDistilled or demineralized water is recommend-ed for cleaning and rinsing of telescopes.

Cleaning Instructions forHOPKINS® AND HOPKINS® IITelescopesCAUTION: WEAR PROTECTIVE GLOVES,CLOTHING AND A FACE MASK FOR CLEAN-ING OF CONTAMINATED TELESCOPES.CAUTION: DO NOT clean the KARL STORZHOPKINS® and HOPKINS® II Telescopes inan ultrasonic bath.CAUTION: Manual cleaning of the KARLSTORZ HOPKINS® and HOPKINS® II Tele-scopes is recommended. However, HOPKINS®

Telescopes without lumens may be cleanedin automated washing units using KARLSTORZ sterilization basket trays #39305C1S/39305C2S/39305L1S/39305L2S with endo-scopic instrument cycles. The basket telescopetrays and its intended content(s) should beprocessed through the cleaning phase cycleonly, NOT through disinfection cycle of auto-mated washing units.CAUTION: The recommended sterilizationparameters are only valid with sterilizationequipment that is properly maintained andcalibrated.

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Cleaning , Disinfection andSterilization Instructions (Continued)1. Remove light cable adapters before

cleaning and sterilization. Do not clean orrinse telescopes with other instrumentsto prevent damage to the telescope.

2. Remove any residual blood, proteinmaterial and contaminants with sponges,soft cloths or a cotton cloth applicatorusing a neutral pH (pH 6.0 to 8.0) enzy-matic cleaning solution (e.g. Enzol,Metrizyme or equivalent diluted to properconcentration per maufacturer’s instruc-tions) and distilled water. KARL STORZdoes not recommend the use of deter-gents alone, as they contain high con-centrations of surfactants which canleave a film on the telescopes. SeeAppendix II for available KARL STORZcleaning accessories.

3. Clean the lenses and fiber optic inletpost with alcohol wipes or sterile cottontip applicators with 70% alcohol to removeany residue or film left after cleaning.

4. Triple-rinse all telescopes with distilledwater, for a minimum of one minute foreach rinse. The rinse water should bediscarded at the end of each rinse, as itwill be contaminated with the cleaningsolution. Thorough rinsing of the tele-scope is necessary for removing anydebris or detergent which could interferewith sterilization.

5. Dry the telescope with a lint-free softcloth or filtered compressed air.

6. Special Instructions for cleaning auto-claveable telescopes: Telescopes thathave been autoclaved many times maydevelop deposits on the glass surfaces.To remove the deposits, clean the tele-scope with KARL STORZ cleaning paste(27661). Put a small amount of cleaningpaste on a moist cotton swab and lightlyspread it on the glass surface. Rubgently to remove any stubborn deposits.

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7. After polishing with the cleaning paste,thoroughly rinse the glass surfaces withwater. Clean the surfaces with 70%alcohol or alcohol wipes to remove alltraces of the cleaning paste. It may benecessary to repeat steps 2 to 5 aboveto ensure all of the cleaning paste isremoved.

Caution: Cleaning with the cleaning pasteshould only be done if the image is cloudy(after approximately 10 to 20 sterilizations)and not as part of the routine cleaning.8. After cleaning, inspect the telescope for

cleanliness and damage as describedabove. (See Inspection Section).

Disinfection Instructions for KARl STORz TelescopesWARNING: High level disinfection isrecommended ONLY for telescopeswhich come into contact with mucousmembranes or minor skin breaches.Disinfection is NOT recommended fortelescopes to be used in any laparo-scopic, arthroscopic, OB/GYN, plastic,reconstructive, aesthetic, or neurologysurgical procedures.CAUTION: Any deviations from the recom-mended disinfection parameters must be val-idated by the user.CAUTION: Before disinfection, the instru-ments must be thoroughly cleaned, rinsed,and dried.CAUTION: To avoid damage to the instru-ments, do not immerse the devices in disin-fectant solution for longer than one hour.KARL STORZ HOPKINS® and HOPKINS® IITelescopes may be chemically disinfectedusing high-level disinfectant solutions con-taining a 2.4% concentration of glutaralde-hyde (e.g. CIDEX®, a 14-day glutaraldehydesolution) or 0.55% ortho-phthalaldehyde(e.g. CIDEX® OPA, a 14-day solution).

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Cleaning , Disinfection andSterilization Instructions (Continued)KARL STORZ does not recommend the useof CIDEX® PLUS or other 28-day room tem-perature glutaraldehyde solutions for manualhigh level disinfection, as they contain highconcentrations of surfactants, which maydry and crystallize on the telescopes if theyare not thoroughly rinsed. The crystalline formof the surfactant can become conductive toelectricity providing a pathway for arcing.Glutaraldehyde solutions with concentrationsgreater than 2.4% should be avoided, as ahigher percentage of glutaraldehyde maydamage the telescopes.1. Place the telescopes into separate

plastic containers. Plastic containersshould be used to avoid scratching ofthe instruments and to eliminate elec-trolytic corrosion, which may occurwhen dissimilar metals are soaked in thesame solution. Do not soak telescopeswith other instruments to prevent potentialdamage.

2. Prepare the disinfecting solution foruse:2.4% Glutaraldehyde Solution (e.g. CIDEX®)

Activate the glutaraldehyde solution byadding the entire contents of activatorvial to the solution in the container.Shake well. Activated solution imme-diately changes color to green,thereby indicating the solution isready to use. Use CIDEX® (ActivatedDialdehyde) Solution Test Strips toverify the solution is above the mini-mum effective concentration (MEC).Test the solution prior to each use.Do not use activated solution beyondstated 14 day reuse life. Record thedate of activation and the expirationdate on the container.

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0.55% ortho-Phthalaldehyde (e.g. CIDEX OPA)

No activation is necessary. Use CIDEX®

(Activated Dialdehyde) Solution TestStrips to verify the solution is aboveteh minimum effective concentration(MEC). Test the solution prior to eachuse. Record the date the solution waspoured out of the original container.

3. Completely immerse the device. Caremust be taken to remove any air bubblesadhered onto the surface of the immersedtelescopes. Fill the instrument and irriga-tion channels with disinfectant solution.A large Luer tip syringe is useful fordrawing disinfectant solution into theinstrument channel.

4. Utilize the following disinfection condi-tions to achieve high-level disinfection:2.4% Glutaraldehyde Solution (e.g. CIDEX®)

Completely immerse the telescope inthe undiluted 2.4% glutaraldehydesolution for a minimum of 45 minutesat 25˚C (77˚F), not to exceed 1 hour.

0.55% ortho-Phthalaldehyde (e.g. CIDEX OPA)

Completely immerse the telescope inthe undiluted solution for a minimumof 12 minutes at 20˚C (68˚F) or higher,not to exceed 1 hour.

5. After disinfection is completed, removethe telescope from the disinfectantsolution and completely immerse in alarge volume of sterile water. Keep theinstruments totally immersed for a mini-mum of one (1) minute in duration. Flusha minimum of 500 mL of water throughall lumens during each separate rinse.Repeat this procedure for a total ofthree (3) immersion rinses. Discard thewater after each rinse, as it will be con-taminated with the disinfectant. Usefresh sterile water for each rinse.

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Cleaning , Disinfection andSterilization Instructions (Continued)

Thorough rinsing of the telescope isessential for preventing the toxic effectsof any residual disinfectant solution.Note: Please refer to the disinfectantmanufacturer’s Instructions-for-Use formore detailed information regarding theuse of the disinfectant solution, includingproper rinsing techniques.

6. Dry the telescope with a lint-free sterilecloth or filtered compressed air. Tothoroughly dry the instrument and irri-gation channels, flush the channels with70% isopropyl alcohol.

CAUTION: Light transmission could beconsiderably impaired due to incompleterinsing. Any disinfectant or cleaning solutionresidues on the light post could burn into thelight post when the fiber optic light cable isconnected.

Sterilization Instructions forTelescopesRoutine ethylene oxide (EtO) sterilization isrecommended for initial and subsequent ster-ilization of all HOPKINS® and HOPKINS® IITelescopes. To achieve the desired sterilityassurance level (SAL) of 10-6, KARL STORZrecommends the following EtO, steam,STERRAD® sterilization methods.CAUTION: Steam sterilize only KARL STORZtelescopes marked 'AUTOCLAV'! Non-auto-clavable telescopes will suffer irreparabledamage.CAUTION: Do not use Immediate-Use Steam(FLASH) sterilization for any KARL STORZHOPKINS® or HOPKINS® II telescopes.CAUTION: Before sterilization, the HOPKINS®

and HOPKINS® II Telescopes must be thor-oughly cleaned and all organic material,blood and cleaning solution completelyremoved.CAUTION: During sterilization, telescopesshould not come into direct contact withmetal.

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CAUTION: The recommended sterilizationparameters are only valid with sterilizationequipment that is properly maintained andcalibrated.CAUTION: Any deviations from the recom-mended parameters for sterilization shouldbe validated by the user.CAUTION: KARL STORZ recommends theuse of one cleaning agent and one sterili-zation method to prevent the unknown rateof material degradation due to material-chemical interactions from various cleaningand sterilization processes.

Ethylene Oxide (EtO) Gas Sterilization

1. Place the HOPKINS® and HOPKINS® IITelescopes in a sterilization tray.

2. Wrap with two layers of FDA cleared poly-propylene wrap or equivalent material.

3. KARL STORZ has validated Ethylene Oxide(EtO) sterilization for the telescopes usingthe following parameters:

Validated Parameters for EthyleneOxide (EtO) Gas Sterilization

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100% Ethylene Oxide

CONDITIONING PARAMETERS

Temperature (set point): 55 °C (131 °F)Humidity : >70% RHVacuum (set point): 1.3 psiaConditioning Dwell Time: 30 minutes

STERILIZATION PARAMETERS*

Sterilant: 100% Ethylene oxideTemperature (set point): 55°C (131°F)Humidity: >70% RHHumidity Dwell Time 30 – 45 minutesEO Gas Concentration*: 725 ± 30 mg/LEO Gas Exposure Time*: 120 min. (full cycle)Aeration Time: 12 hrs. (full cycle)Aeration Temperature: 51 – 59 °C

(124˚ – 138˚F)

Cleaning , Disinfection andSterilization Instructions (Continued)

STERRAD® SystemKARL STORZ telescopes are compatible withthe STERRAD® 100S, NX and 100NX steriliza-tion systems. The STERRAD® System utilizes asyngerism between hydrogen peroxide and lowtemperature gas plasma to produce a rapid,low temperature, low moisture inactivation ofmicroorganisms.WARNING: Consult STERRAD® labelingfor lumen size restrictions.CAUTION: STERRAD® sterilization maycause cosmetic changes to the devices thatdo not necessarily impact the function ality ofthe device.CAUTION: All telescopes must be thoroughlyDRIED before loading into the STERRAD®

System chamber. Loads containing moisturemay cause a cycle cancellation.CAUTION: Use only STERRAD® Instrumenttrays in the sterilization chamber. These traysare specially designed to allow the plasma tosurround the items.CAUTION: Use only polypropylene steriliza-tion wrap and polyolefin pouches. Do not usepaper pouches or sterilization wraps contain-ing wood pulp or cotton.CAUTION: Any deviations from the recom-mended STERRAD® System sterilizationparameters must be validated by the user.Note: Instruments that KARL STORZ has deter-mined to be compatible with the STERRAD®

System sterilization process have been vali-dated with at least one hundred STERRAD®

cycles.1. Clean and thoroughly dry all instruments.2. Place the telescopes in STERRAD® instru-

ment trays, wrap in polypropylene sterili-zation wrap or enclose in polyolefinpouches. Place STERRAD® indicatorstrips in all trays and pouches.

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3. Load the STERRAD® sterilizer, arrangingthe items such that the hydrogen per-oxide plasma can surround them. Donot allow any items to touch the wall ofthe sterilizer.

4. Please consult the STERRAD® SystemOperators Manual for detailed instruc-tions for use.

Steam SterilizationWARNING: ONLY KARL STORZ HOP-KINS® and HOPKINS® II TELESCOPESmarked “AUTOCLAV” can be steamsterilized.WARNING: Do not use Immediate-UseSteam (FLASH) sterilization for anyKARL STORZ HOPKINS® and HOPKINS®

II TELESCOPES.CAUTION: Sudden changes in temperaturemay fracture the glass components of tele-scopes. Do not immediately expose telescopesto air after removal from the autoclave.CAUTION: Never attempt to cool tele-scopes by pouring cool, sterile liquid over thetelescope. Forced cooling will cause severedamage to the telescope.CAUTION: Before steam sterilization all tel-escopes must be thoroughly cleaned and anyorganic material, blood and cleaning solutioncompletely removed.1. Place the HOPKINS® or HOPKINS® II

Telescopes marked “autoclav” in a sterili-zation tray.

2. Wrap with two layers of FDA-cleared poly-propylene wrap or equivalent material.

3. KARL STORZ has validated the followingsteam sterilization parameters:

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Cleaning , Disinfection andSterilization Instructions (Continued)• Pre-vacuum:Pre-vacuum or high vacuum sterilization con-sists of four basic phases: a conditioningphase, an exposure phase, an exhaust phaseand a drying phase. The conditioning phaseremoves air from the chamber by pulling avacuum and then warms the instruments byinjecting steam. Sterilization occurs duringthe exposure phase when the chamberreaches a temperature of 132˚C (270˚F) andpressure of 27 psi. The exposure phase in apre-vacuum type of sterilizer is 4.0 minutes.The exhaust phase removes the steam fromthe chamber. The drying phase is accom-plished by pulling an additional vacuum andallowing the instruments to dry under vacuumfor approximately 20 minutes. The followingconditions have been used to validate sterili-zation procedures in a pre-vacuum sterilizer:

Temperature: 132-133˚C (270-275˚F)Pressure: 27 psiExposure Time: 4 minutes for all

instruments3. Trays should be positioned in the sterilizer

so that there is adequate circulation andpenetration of steam, air removal andcondensate drainage. A loosely loadedsterilizer allows the best penetration ofsterilant.

4. At the completion of the steam sterilizationcycle, all telescopes should remainuntouched until adequately cooled.

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References for Cleaningand Sterilization1. The Difficulty of Reprocessing

Reusable Rigid Laparoscopic Forcepsand Other Endoscopic Accessories:Are Disposables the Answer? HealthDevices, Vol. 23, Nos.1-2, pp. 57-58,1994.

2. Descoteaux, J-G, Poulin, E.C., Julein,M. And Guidoin, R. Residual OrganicDebris on Processed SurgicalInstruments. AORN Journal Vol. 62,No. 1, pp. 23 - 29, 1995.

3. Gruendemann, B.J. and Meeker, M.H.Alexander’s Care of the Patient inSurgery, 12th edition. The C.V. MosbyCompany, St. Louis, Mo. 2003.

4. Association for the Advancement ofMedical Instrumentation. Designing,Testing and Labeling ReusableMedical Devices for Reprocessing inHealth Care Facilities: A Guide forDevice Manufacturers. AAMI TIR No.12-2010.

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Inspection Upon ReceiptTHOROUGHLY INSPECT SHIPMENT IMMEDIATELY UPON ARRIVAL.Although KARL STORZ products are carefullypacked to minimize in-transit damage, allshipments should be carefully examinedupon receipt and if a product is damaged,Customer must document the nature andextent of the damage and immediately con-tact KSEA. If concealed loss or damage isdiscovered, Customer must retain all packingmaterials and immediately notify KSEA,requesting an inspection. If shipments arereceived short, Customer must contactKSEA’s Customer Support Department atonce. KSEA reserves the right to make partialshipments on any Order. Invoices for partialshipments are payable upon receipt. KSEAis not liable for any damages caused by orattributable to delays and/or non-deliverydue to any cause whatsoever.

Maintenance and RepairKARL STORZ recommends that the instru-ments be checked once a year by KARLSTORZ Endoscopy-America, Inc. or by anauthorized agent. All services such as mod-ifications, repairs, calibrations, etc., may onlybe performed by KARL STORZ Endoscopy-America, Inc. or by an authorized agent.

Return PolicyA return merchandise authorization (RMA),must be obtained from KSEA’s CustomerSupport Department prior to returning anyproducts. When phoning or writing KSEA,for an RMA, the Customer Support Rep-resentative must be provided with: (1) Customer name and number, as itappears on the invoice; (2) the telephone number and the personto contact;

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(3) the applicable P.O. number; (4) the KARL STORZ catalog number and,if applicable, the serial number for eachproduct; and, (5) the reason for the return. KSEA reserves the right to refuse or returnany products sent back to KSEA withoutprior authorization of its Customer SupportDepartment. Returns must be carefullypacked and shipped pre-paid to KSEA, attn:RMA number. KSEA’s Customer SupportDepartment will provide the return addressand the RMA number. Shipping chargeswill be reimbursed if the return was due toan error on the part of KSEA. When returningproducts, Customer should include a copyof the original invoice or packing slip toensure prompt issuing of credit. Full creditwill only be issued for products that arereturned within 30 days of invoice date, andso long as such items are unused, in resal-able condition and in their original productcontainer. All products returned after 30days from the date of invoice are subject toa 15% restocking fee. The following products may not be returnedfor credit or exchanged: (1) products held longer than 90 days frominvoice date; (2) sterile packaged products where thepackage is opened and/or damaged; (3) discontinued products; (4) instruments that are etched or engravedby Customer; (5) products damaged by the Customer; (6) products purchased “as is” or as demoproducts; and, (7) used products.

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In order to prevent the transmission of dis-ease to the medical facilities’ and/or KSEA’spersonnel, all products must be cleaned andthen sterilized and/or disinfected beforesending such products back to KSEA, whoreserves the right to return unclean andcontaminated products to the Customer.Additionally, if any product becomes dam-aged and is not immediately returned, KSEAassumes no responsibility or liability forCustomer’s continued use of that damagedproduct. KSEA does not guarantee the per-formance, and may decline to repair oraccept for repair/exchange, any productthat has been repaired, modified and/oraltered by any person or entity other thanKSEA or an authorized repair facility of KSEA.

Repair ProgramIf repairs become necessary, for other thandamages incurred during initial shipment,the Customer must follow the RMA proce-dure set forth in the "Return Policy", above.Warranty repairs will be made without charge(see "Warranty Policy," below, for coveredrepairs). All other repairs are subject toKSEA's applicable standard repair orexchange charges. If requested, Customerwill be advised of the estimated cost of therepair work or a product exchange before itis undertaken. All repairs carry a 90 daywarranty. Exchange products carry the applicableKARL STORZ product warranty. If the dam-aged product is not returned within thirty(30) days of receipt of the replacementproduct, Customer will be invoiced for the fulllist price of the replacement. KSEA reservesthe right to refuse or return any productsent back without prior authorization ofKSEA’s Customer Support Department.

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Warranty PolicyExcept as otherwise provided herein and/orby the applicable warranty information for aspecific product or type of product, all KARLSTORZ-branded products are generallywarranted to be in good working order atthe date of delivery and free from defects inworkmanship and materials for one (1) yearfrom date of delivery. However, since someproducts carry a shorter or a longer warrantyperiod, Customer should check with KSEA'sCustomer Support Department or productspecific literature, instruction manual and/orlabeling for the exact warranty period. Anysuch product(s) with a defect occurringduring the applicable warranty period will bepromptly replaced or, at the sole discretionof KSEA, repaired at no charge to Customer.THIS WARRANTY IS IN lIEU OF AllOTHER WARRANTIES, EXPRESS, IMPlIEDAND/OR STATUTORY, INClUDING, BUTNOT lIMITED TO WARRANTIES OFMERCHANTABIlITY, FITNESS AND/OROF SUITABIlITY FOR A PARTICUlARPURPOSE, WITH RESPECT TO All KARlSTORz PRODUCTS OR SERVICES. ANYAND All OTHER WARRANTIES, REP-RESENTATIONS AND/OR GUARANTEES,OF ANY TYPE, NATURE OR EXTENT, BEIT IMPlIED, EXPRESS AND/OR WHETHERARISING UNDER OR AS A RESUlT OFANY STATUTE, lAW, COMMERCIAlUSAGE, CUSTOM, TRADE OR OTHER-WISE, ARE HEREBY EXPRESSlYEXClUDED AND DISClAIMED.

Any contrary course of performance by andbetween the parties will not modify any rep-resentations and/or warranties set forthherein. KSEA neither assumes nor authorizesany person to assume for it any other liabilitiesin conjunction with and/or related to the saleand/or use of its products. To ensure properuse, handling and care of KARL STORZproducts, Customer should consult theproduct specific literature, instruction manual,

and/or labeling included with the product orotherwise available. Repairs, modifications oralterations of KARL STORZ products, per-formed by any person or entity, other thanby KSEA or an authorized repair facility ofKSEA, nullifies and otherwise voids allapplicable KARL STORZ warranties. Repairor replacement of a KARL STORZ productshall not extend the term of any applicablewarranty. The remedies provided hereinare Customer's exclusive remedies underthis Warranty Policy.

Limitation of LiabilityKSEA is not liable, directly or by way ofindemnity, either expressly or impliedly, for:(1) any damages which might arise or becaused, whether by the Customer or by anyof the users of the products provided byKSEA, as a result of, in connection with, orotherwise attributable to: (a) misuse, abuse,mishandling and/or improper operationand/or storage; (b) repairs, servicing, mod-ifications and/or alterations performed byany person or entity, other than KSEA or anauthorized repair facility of KSEA; (c) use incombination with adaptors, accessoriesand/or equipment from other manufacturersunless authorized or recommended by KSEAor, (d) use in any manner other than thosefor which such products are designed andare otherwise intended to be used; and, (2)any special, incidental, consequential,punitive, exemplary or indirect damages,including but not limited to alleged damagesfor delayed shipment, non-delivery, productfailure, product design or production,inability to use such products or services,loss of future business (lost profits), or fromany other cause, whatsoever, in connectionwith or arising from the purchase, sale,lease, rental, installation or use of suchKARL STORZ products, even if Customerhas been advised of the possibility of suchdamages.

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SOME JURISDICTIONS DO NOT AllOWEXClUSIONS AND DISClAIMERS OFCERTAIN WARRANTIES OR lIMITATIONSOF lIABIlITY, SO THE lIMITATIONSAND/OR EXClUSIONS, SET FORTH INTHESE TERMS AND CONDITIONS, MAYNOT APPlY. IN THAT EVENT, KSEA’SlIABIlITY WIll BE lIMITED TO THEGREATEST EXTENT PERMITTED BYlAW IN THE SUBJECT JURISDICTION.

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Appendix I

UrologyIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes areto be used for visualization of the surgical siteduring diagnostic and therapeutic urologyprocedures.Contraindications: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arecontraindicated for use when, in the opinionof a qualified physician, such use would cre-ate a condition that would be dangerous forthe patient.

General SurgeryIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arefor use during general endoscopic andlaparoscopic surgical procedures (diagnosticand therapeutic).Contraindications: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arecontraindicated for use when, in the opinionof a qualified physician, such use would cre-ate a condition that would be dangerous forthe patient.

ThoracoscopyIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arefor use to view the thoracic cavity during diag-nostic and operative endoscopic procedures.Contraindications: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arecontraindicated for use when, in the opinionof a qualified physician, such use would cre-ate a condition that would be dangerous forthe patient.

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Ear, Nose and ThroatIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arefor use to view the nasal, sinus and/or pha-ryngeal cavities during diagnostic and opera-tive endoscopic procedures.The KARL STORZ HOPKINS® and HOPKINS® IITelescopes are for use to view the bronchi,trachea and esophagus during diagnosticand operative endoscopic procedures.The KARL STORZ HOPKINS® and HOPKINS® IITelescopes are for use to view the tympanicmembrane and middle ear during diagnosticand operative endoscopic procedures.The KARL STORZ HOPKINS® and HOPKINS® IITelescopes are for use to view the larynx duringdiagnostic and operative endoscopic proce-dures.Contraindications: The KARL STORZ HOP-KINS® and HOPKINS® II Telescopes are contraindi-cated for use when, in the opinion of a qualifiedphysician, such use would create a condition thatwould be dangerous for the patient.

ArthroscopyIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arefor use during diagnostic and therapeuticarthroscopic surgical procedures in the knee,shoulder, elbow, wrist, ankle, jaw and hip.Contraindications: The KARL STORZ HOP-KINS® and HOPKINS® II Telescopes are con-traindicated for use when, in the opinion of aqualified physician, such use would create a con-dition that would be dangerous for the patient.

Plastic SurgeryIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes arefor use during endoscopic plastic, recon-structive and aesthetic surgical procedures.Contraindications: The KARL STORZ HOP-KINS® and HOPKINS® II Telescopes are con-traindicated for use when, in the opinion of aqualified physician, such use would create a con-dition that would be dangerous for the patient.

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Appendix I (Continued)

Gynecology (laparoscopy)Indications for Use:• unexplained pelvic pain (acute, chronic)• infertility work-up• tubal sterilization• unexplained primary or secondary amenor-rhea

• diagnosis and/or treatment of ectopic preg-nancy

• evaluation, diagnosis and/or treatment orsmall pelvic tumors, including myomata

• evaluation of congenital anomalies of thepelvic organs

• retrieval of small foreign bodies• determination of the presence and extent ofpelvic endometriosis

• determination of the presence and extent ofpelvic inflammatory disease

• laparoscopic assisted vaginal hysterectomy• evaluation of ovarian endocrinopathy• visualization, diagnosis and/or treatment ofperforate abdominal organs

Strong Relative Contraindications:• Class IV cardiac decompensation• infection with acute peritonitis• bowl obstruction• ileus• intraperitoneal hemorrhage• diaphragmatic herniaOther Relative Contraindications:• cardiac disease• diaphragmatic hernia• previous abdominal surgery• obesity• thin nulliparious patient• pregnancy greater than 16 week size orabdominal mass of comparable size

• chronic obstructive lung disease• liver failure with established collateral ves-sels

• invasive carcinoma of the cervix• medical contraindication• intolerance to anesthesiaWARNINGS: For use only by clinicians trained in laparoscopy

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Precautions:• Ultrasonography prior to laparoscopy mayidentify clinical conditions that will alterpatient management.

• Abdominal puncture sites 10 mm or greater(for the introduction of auxiliary instrumenta-tion) may be a source of herniation.

• Lasers and electrosurgical probes shouldnot be activated simultaneously. Further,when one is activated, the tip of the othershould be completely retracted. This avoidsdeflection of the energy to the other tip.

• Electrosurgical Safety: Inadvertent burnscan occur when the appropriate patientreturn path is obstructed. Inadvertent burnsmay also occur as a result of capacitivecoupling.

WARNING: Although not reported in thecurrent literature with the use of monopolarresectoscopes when used with non-electrolyt-ic distending media, air/gas emboli havebeen reported with the use of bipolarresectoscopes and laser when usedin saline for uterine surgery. Propermonitoring of end-tidal CO2, oxygen satura-tion and possibly Doppler TE echo should bemonitored during the procedures by the oper-ating team. Removal of the weighed specu-lum and use of a modified Trendelenberg andmonitoring of intrauterine pressure are alsorecommended to reduce intravasation of uter-ine contents into the vascular system.

Diagnostic HysteroscopyIndications for Use:• abnormal uterine bleeding• infertility and pregnancy wastage• evaluation of abnormal hysterosalpin-gogram

• intrauterine foreign body• pelvic pain• evaluation of abnormalities of the endo -metrium

• monitoring IUD status

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Appendix I (Continued)Absolute Contraindications for use:• acute Pelvic Inflammatory Disease (PID)Relative Contraindications for use:• inability to distend uterus• cervical/vaginal infection• uterine bleeding or menses• known pregnancy• invasive carcinoma of the cervix• recent uterine perforation• medical contraindication• intolerance to anesthesiaWarningsSuspicion of pregnancy should suggest apregnancy test prior to the performance ofdiagnostic hysteroscopy.PrecautionsVaginal ultrasonography prior to hys-teroscopy may identify clinical conditions thatwill alter patient management.

Operative HysteroscopyIndications for Use:• directed biopsy• removal of submucous fibroids and largepolyps

• submucous myomectomy• transection of intrauterine adhesions• transection of intrauterine septa• endometrial ablationAbsolute Contraindications for use:• acute Pelvic Inflammatory Disease (PID)Relative Contraindications for use:• inability to distend uterus• cervical/vaginal infection• uterine bleeding or menses• known pregnancy• invasive carcinoma of the cervix• recent uterine perforation• medical contraindication• intolerance to anesthesia

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Relative Contraindications toEndometrial AblationHysteroscopic endometrial ablation, whetherby laser or electrosurgery, should not beundertaken before adequate training, precep-torship and clinical experience. Additionally,tissue sampling is required prior to destruc-tion of the endometrium. The following areclinical conditions that can significantly com-plicate hysteroscopic endometrial ablation:• adenomatous endometrial hyperplasia• severe adenomyosis• pelvic pain (subtle PID)• uterine anomaliesRelative Contraindications toHysteroscopic MyomectomyHysteroscopic myomectomy, whether bylaser or electrosurgery, should not be under-taken before adequate training, preceptor-ship and clinical experience. The followingare clinical conditions that can significantlycomplicate hysteroscopic myomectomy:• severe anemia• inability to circumnavigate the myomaWarningsIf a liquid distention medium is used (continu-ous flow hysteroscopy), strict fluid intake andoutput surveillance should be maintained.Intrauterine instillation exceeding 2 litersshould be followed with great care to avoidthe possibility of fluid overload.Complications• hyponatremia• hypothermia• uterine perforation, resulting in possibleinjury to the bowel, bladder, major bloodvessels and ureter

• pulmonary edema• cerebral edema• air or gas embolization

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Appendix I (Continued)

NeurologyIndications for use:KARL STORZ Neuroendoscopes are indicatedfor use during neuroendoscopic surgical pro-cedures for viewing the ventricles of the brainand performing diagnostic and therapeuticprocedures.Contraindications:• Use of KARL STORZ Neuroendoscopes arecontraindicated whenever neuroendoscopyis contraindicated.

• Use of KARL STORZ Neuroendoscopes arecontraindicated in patients suspected of beinginfected with Creutzfeldt-Jakob disease.

Warnings:• Infusion of fluids into the cranial cavity with-out proper venting can lead to intracranialhypertension. Introduction and evacuationof fluids should be regulated by using theinflow and outflow stopcocks.

• During infusion of fluids when irrigating,make sure that the outflow path does notbecome obstructed. Increased intracranialpressure may result.

• Use of a camera is recommended with theneuroendoscope to ensure optimal viewingand to maintain sterility of the system. Ifdirect viewing is desired, make sure youreye does not contact the eyepiece of theneuroendoscope. Sterility will be compro-mised.

• Insufficient cleaning may compromise thesterility of the neuroendoscope.

• The neuroendoscope must be sterilizedafter each use.

• Disinfection does not sterilize neuroendo-scopes.

• The use of the neuroendoscope with cablesand accessories may produce tension andtorquing forces on the neuroendoscopeduring use. To prevent pressure on, or injuryto, the brain tissue, always be sure that thebody of the neuroendoscope is supportedadequately.

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37

• Do not allow the tip of the neuroendoscopeto remain in contact with brain tissue for pro-longed periods of time.

Cautions:• Do not use the neuroendoscopes withoutthe operating sheath.

• Immobilize the neuroendoscope using yourhospital’s standard stabilization system toensure proper stabilization of the neuroen-doscope during use.

• Irrigation fluids should be warmed to bodytemperature prior to infusion.

• When handling the neuroendoscope,always hold it by the eyepiece assembly.

• Avoid actions that might flex or bend theneuroendoscope shaft.

• Do not drop the neuroendoscope, or allow itto strike any hard surface.

• Do not place any object on top of the neu-roendoscope.

• Do not touch the lenses at either end of theneuroendoscope.

• Do not introduce or withdraw surgical instru-ments through the neuroendoscope instru-ment channel while the instrument jaws areopen; damage to the neuroendoscope andinstruments may occur.

Precautions:All procedures using KARL STORZ Neuro -endoscopes should be performed by a quali-fied neurosurgeon with neuroendoscopicexperience.

DentistryIndications for Use: The KARL STORZHOPKINS® and HOPKINS® II Telescopes areto be used whenever magnification is desir-able and/or access is restricted during den-tal, endodontic, and periodontic procedures.Contraindications for use: The KARLSTORZ HOPKINS® and HOPKINS® II Tele -scopes are contraindicated for use when, inthe opinion of a qualified dentist, endodontist,or periodontist, such use would create a con-dition that would be dangerous for the patient.

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Appendix IICleaning Accessories availablefrom KSEA

Cleaning Brushes:27648 A Cleaning brush. Length: 50 cm27650 A Same. Length: 35 cm. Large size27662 Grasping forceps for careful han-

dling of instruments

Metal Sterilizing Cases:27640 A Metal case with cover for tele-

scopes with holes for sterilization,400 x 75 x 50 mm

27640 B Same, 260 x 75 x 50 mm27640 C Same, 615 x 75 x 50 mm27641 A Same, 640 x 140 x 50 mm27641 C Same, 500 x 200 x 50 mm27641 E Same, 400 x 150 x 50 mm

Protective tubes for Hopkins telescopes:723750 A Length, 11.9 cm723750 B Length, 19.7 cm723750 E Length, 31.9 cm723750 H Length, 46.8 cm

Cleaning pistol and attachments:27660

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39

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DISTRIBUTED AND SERVICED BY:

KARl STORz Endoscopy-America, Inc.2151 East Grand AvenueEl Segundo, California 90245-5017Telephone 424 218 8100Toll Free 800 421 0837Telefax 800 321 1304

©2010 KARL STORZ Endoscopy-America, Inc

KARL STORZ GmbH & Co.Mittelstraße 8, D-78532 Tuttlingen, GermanyPostfach 230, D-78503 Tuttlingen, Germany

Telegramm: EndoskopieTelefon: (07461) 70 80, Telex: 762 656 storz d

Telefax: (07461) 70 81 05

KARL STORZEndoscopy-America, Inc.2151 East Grand Avenue

El Segundo, CA 90245-5017Telephone: (424) 218-8100Toll Free: (800) 421-0837Telefax: (800) 321-1304

KARL STORZEndoscopy-Canada, Ltd.

2345 Argentia road, Suite 100Mississagua, Ontario,Canada L5N 8K4

Telephone: (905) 816-8100Toll Free: (800) 268-4880Telefax: (905) 858-0933

KARL STORZEndoscopia Latino America

815 N.W. 57th Ave., Ste. No. 480Miami, FL 33126-2042, USATelefono: (305) 262-8980Telefax: (305) 262-8986

IM-000003-9.0 (04/11)