General Reprocessing Instructions for KARL STORZ Products ...

GeneralReprocessingInstructions

forKARL STORZProducts(USA)

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Important information forusers of KARL STORZinstrumentsPlease read this entire instructions-for-usecarefully before using the KARL STORZinstruments. Failure to follow the instruc-tions, cautions and warnings presentedin this manual may result in serious conse-quences to the patient. Refer to PI-000092included with your product to identifythe appropriate reprocessing methodsfor your KARL STORZ instruments. ForFlexible Endoscopes, please refer to theInstructions-for-use (IFU) included withyour device.

Procedures for proper handling and careof KARL STORZ instruments are describedin this instructions-for-use. KARL STORZendoscopes and accessories are delicatesurgical instruments and should be han-dled with care. Improper use during sur-gical procedures will result in damage,breakage or patient injury. KARL STORZEndoscopy-America, Inc. assumes noliability if the instruments are misused,mishandled or otherwise abused. Properhandling and care, as described in thisinstructions-for-use, will prolong the lifeof these instruments.

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ContentsImportant Information...........................2

Why is Water Quality Important?Water quality requirements ..................4

Pre-Cleaning Preparation.....................7

Cleaning Instructions for Instruments ..8

Sterilization Instructions(General Introduction)........................11

Ethylene Oxide (EtO) Sterilization ......12Table 1 – EtO Cycle Parameters....14

Steam Sterilization..............................16Pre-Vacuum...................................17Gravity-Displacement....................18Intermediate-Use (Flash) Steam Sterilization .........................19

STERRAD® Sterilization Systems .......20Table 2 – STERRAD® SterilizationSystems Lumen Claims.................25

STERIS® Amsco V-PRO®

Sterilization Systems......................27

STERIS® SYSTEM 1E Liquid ChemicalSterilant Processing System..........30

High Level Disinfection ......................31Manual HLD...................................33Automated HLD.............................36

Note: This document is updated fre-quently. Please check for latest update.

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WHY IS WATER QUALITY IMPORTANT?The quality of water used for instrumentprocessing has a considerable influenceon the proper function and longevity ofan instrument. A hard layer (lime deposits,scale) can form on instruments dependingon water hardness and temperature thatcan be very difficult to dissolve. Excessiveconcentrations of chlorides can also causepitting. Cleaning solutions made up withtap water will leave mineral residues oninstruments that will not wash off fullyeven with de-ionized water. Over time,these residues will build and could affectinstrument function.

The quality of the final rinsing water is apart of the hygienic standards for repro-cessing of medical devices. Rinsing waterfor final manual cleaning and disinfectionof medical devices without subsequentsterilization has to be absolutely free ofpathogenic micro-organisms. When aninstrument is rinsed in tap water reconta-mination can occur.

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To recap:Water quality impacts on the following:

1. Medical Devices – • Damage: pitting and corrosion with eventual loss of device function • Reduction in cleaning efficacy • Interference with high level disinfection/sterilization efficacy

2. Patient – • Infection transmission • Adverse reaction such as inflammation and fever

General characteristics to be consideredfor reprocessing medical device:

1. Microbiological content of the water2. Inorganic and organic content of the

water

Water Quality Requirements:

Distilled or demineralized water is recom-mended for cleaning and rinsing of allinstruments. If the customer elects touse tap/potable water, refer to the waterquality requirements as described below.Check with your institution’s policies onwater quality.

1. Pre-cleaning: Potable water may be used for pre-clean-ing and rinsing a device immediatelyafter patient use to remove gross con-tamination. Water temperature should notexceed 113˚F (45˚C) to prevent coagu-lation blood and other proteins.

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2. Cleaning

Potable water is adequate for rinsing andremoving debris loosened by the cleaningprocess. For “critical” and “semi-critical”devices, high-purity water (processedwater) is recommended for final rinsing.

If high-purity water is not available, freshfiltered potable/tap water at the point ofuse may be used for final rinsing ofcritical and semi-critical devices.

3. High Level Disinfection:

Follow the high level disinfectant manu-facturer’s water quality recommendationfor dilution of liquid chemical high leveldisinfectant (as applicable). Sterile orbacteria-free water should be used forfinal rinsing after manual high level disin-fection of “semi-critical” devices.

If sterile or bacteria-free water is notavailable, high-purity water (processedwater) or fresh filtered potable/tap waterat the point of use may be used for finalrinsing of the endoscope’s external sur-faces and inner channel(s). Flush thechannel(s) with filtered alcohol (70% iso-propyl alcohol) followed by purging thechannel(s) with dry, oil-free compressedair (<5psi). Dry the external surfaces ofthe instruments with a lint-free sterilecloth or dry, oil-free compressed air(<5psi).

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WARNING: KARL STORZ instrumentsshould be thoroughly cleaned and highlevel disinfected or sterilized accordingto validated infection control proceduresprior to use and subsequent reuse.

Pre-Cleaning Preparation:

1. Immediately after a procedure, atthe point of use (e.g. operating room),wipe the instruments with a soft, lint-free, disposable cloth, moistenedwith water to remove all heavy soiling.

2. Contain and transport the contami-nated instruments with a soft, lint-free,disposable cloth, moistened withwater or cleaning detergent to removeall heavy soiling.

3. If immediate cleaning is not feasible,place the instruments in a containerand soak for no longer than 30 minuteswith a neutral/mild pH enzymaticcleaning solution (e.g. Enzol), dilutedwith water to proper concentrationper manufacturer’s instructions.

CAUTION: DO NOT soak telescopesin any solution (including water) for longerthan 60 minutes.

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Cleaning Instructions for Instruments:

CAUTION:WEAR PROTECTIVE GLOVES,CLOTHING, AND A FACE MASK FORCLEANING OF CONTAMINATED INSTRU-MENTS.

CAUTION: Do not process sheaths withceramic beaks or optical devices such astelescopes, cameras, and light cables inan ultrasonicator.

CAUTION: Do not soak or immerse in aliquid /chemical solution for the followinginstruments:

• Telescopes with HAMOU eyepiecedrive mechanism

• Magnifying lenses with drivemechanism

• IMPERATOR handpieces

Note: Refer to the “Water Quality Re-quirements” Section.

1. All instruments with removable partsshould be disassembled. All movingparts should be in the open position.

2. Thoroughly rinse the instruments toremove all gross debris prior to clean-ing.

3. Manual cleaning is recommended.Instruments (except the aforemen-tioned devices) with difficult to reachareas such as joints, lumens and

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stopcocks can be processed usingan ultrasonicator. It is important tofollow the manufacturer’s instructionsfor operating the ultrasonicator.

Note: HOPKINS® Rigid Telescopeswithout lumens may be processedin automated washing units usingKARL STORZ sterilization basket trays#39305C1S/39305C2S/39305L1S/39305L2S with endoscopic instrumentcycles. The Telescopes must not beprocessed in an ultrasonic cycle ordamage will result to the Telescope.

4. Completely immerse the instruments,with instrument jaws open, in a neutral/mild pH enzymatic cleaning solution(e.g. Enzol), diluted to proper con-centration per manufacturer’s instruc-tions. If applicable, be sure that thelumens of all instruments are filled withcleaning solution. Keep the instrumentsimmersed for 10 minutes.

5. While the instruments are immersed,and using the appropriate cleaningbrush, brush the surface of all instru-ments. In addition, brush the insideof all lumens with the appropriatesize brush provided for your device.

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Cleaning Instructions forInstruments (Continued):6. After the immersion period, remove

the instruments from the cleaningsolution and completely immerse ina large volume of water (e.g. 2 gallons).Be sure to flush all lumens with waterto remove the cleaning solution. Discardthe water and repeat with fresh waterfor a total of three immersion rinses.

7. Dry the instruments with a lint free softcloth or clean, dry, oil-free compressedair (<5 psi). To dry out instrumentswith lumens, flush the lumen withclean, dry, oil-free compressed air(<5 psi). Cleaning pistols (KSEA partnumber 27660) with the smallestattachments are useful for drying theinstruments with compressed air.

8. After cleaning, inspect the instrumentsfor cleanliness and damage.

9. Do not use any instruments or acces-sories that show visible signs of damageor that are difficult to use. Any mal-function of an accessory or instrumentduring a procedure could result ininjury to the patient and further damageto the instrument.

10. Before steam sterilization, lubricateall moving parts of the instrument witha non-silicone water soluble instrumentmilk or lubricant (e.g. Codman Preserveper manufacturer’s instructions).

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Silicone or oil based lubricants arenot recommended for use becausesterilants cannot penetrate the siliconeor oil.

Sterilization InstructionsRoutine sterilization is recommended forinitial and subsequent sterilization of allinstruments. Refer to the KARL STORZSterilization and High-Level DisinfectionChart (PI-000092) provided with yourproduct to identify the appropriate steril-ization method for your product.

WARNING: Before sterilization, theinstruments must be thoroughlycleaned and all visible organic material,blood and cleaning solution completelyremoved.

WARNING:KARL STORZ recommendsthat, in order to assure sterility, allinstruments should be sterilized dis-assembled and then reassembled in asterile field.

WARNING: Sterilization is recommend-ed for “critical” instruments to be usedfor Hysteroscopy, Neuroendoscopy,Arthroscopy, or Laparoscopy.

High level disinfection (minimum re-quirement) is recommended for “semi-critical” instruments which come intocontact only with intact mucous mem-branes or non-intact skin.

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Sterilization Instructions (Continued):

CAUTION: The approved sterilizationparameters are only valid with sterilizationequipment that is properly maintainedand calibrated.

CAUTION: KARL STORZ recommendsthe use of one cleaning agent and onesterilization method to prevent the unknownrate of material degradation due to mate-rial-chemical interactions from variouscleaning and sterilization processes.

Ethylene Oxide (EtO) GasSterilizationWARNING: Sterilize the KARL STORZPendulum Camera Heads with the slide-lock mechanism in the open position.1. Place the instruments in an FDA-

cleared sterilization tray or pouch. a. Double wrap the tray with two

single layers of FDA-cleared poly-propylene wrap, using a sequen-tial double wrapping technique.

b. Double pouch the instrumentusing two sequentially sized dis-posable FDA-cleared pouches.The sealed inner pouch shouldfit inside the other pouch withoutfolding.

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Packaging of the instrumentmust be prepared in a mannerthat pouches should be posi-tioned so that plastic faces plas-tic and breathable side facesbreathable side.

2. Load the sterilization pouch orwrapped tray into the sterilizer.

3. Use the following KARL STORZ vali-dated parameters for Ethylene Oxidegas sterilization.

Product Load Configuration Descriptions:

1. Load Configuration 1:The 60-minute EO cycle parameter isrecommended for the following:

• Surface sterilization of non-lumeninstruments (without sterilizationtray) wrapped in two (2) layers of1-ply FDA- cleared polypropylenewrap or equivalent material.

2. Load Configuration 2:The 120-minute EO cycle parameter isrecommended for the following:

Product Load Configuration 1 EO Gas Concentration: 725 ± 30 mg/L EO Gas Exposure Time: 60 minutes


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Table 1

100% Ethylene Oxide

CONDITIONING PARAMETERS (In-Chamber)

Temperature (set point): 55 °C (131 °F) Humidity (set point): 70% RH Vacuum (set point): 1.3 psia Conditioning Dwell Time: 30 minutes

STERILIZATION PARAMETERS Sterilant: 100% Ethylene oxide Temperature (set point): 55°C (131°F) Humidity (set point): 70% RH Humidity Dwell Time 30 – 45 minutes Product Load Configuration 1 EO Gas Concentration: 725 ± 30 mg/L EO Gas Exposure Time: 60 minutes Product Load Configuration 2 EO Gas Concentration: 725 ± 30 mg/L EO Gas Exposure Time: 120 minutes Product Load Configuration 3 EO Gas Concentration: 735 ± 30 mg/L EO Gas Exposure Time: 180 minutes

AERATION PARAMETERS Aeration Time: 12 hours Aeration Temperature: 51 – 59 °C (124˚ – 138˚F) set point 55 °C

EtO Sterilization (Continued)

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• Instruments (lumen or non-lumendevices) placed in sterilizationtray wrapped in two (2) layers of1-ply FDA-cleared polypropylenewrap or equivalent material.

• Instruments with lumen and withoutsterilization tray wrapped in two (2)layers of 1-ply FDA-cleared polypropy-lene wrap or equivalent material.

3. Load Configuration 3:

The 180-minute EO cycle parameter isrecommended for the following:

• Camera Heads product family.The Camera Head (with or withoutsterilization tray) wrapped in two(2) layers of 1-ply FDA-clearedpolypropylene wrap or equiva-lent material.

WARNING: Sterilize the KARLSTORZ Pendulum Camera Headswith the slide-lock mechanismin the open position.

• Sialendoscope with lumen placedin sterilization tray wrapped in two(2) layers of 1-ply FDA-clearedpolypropylene wrap or equiva-lent material.


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Steam Sterilization

WARNING: STEAM STERILIZE ONLYKARL STORZ TELESCOPES MARKED–‘AUTOCLAV’!

NON–‘AUTOCLAVABLE’ TELESCOPESWILL SUFFER IRREPARABLE DAMAGE.

WARNING: Do not use immediate-use (FLASH) steam sterilization for anyKARL STORZ telescopes, light carriers,or light deflectors.

CAUTION: During sterilization, tele-scopes should not come into direct contactwith metal.

1. Place the instruments in an FDA-cleared sterilization tray or pouch.

a. Double wrap the tray with twosingle layers of FDA-cleared poly-propylene wrap, using a sequen-tial double wrapping technique.

b. Double pouch the instrumentusing two sequentially sized dis-posable, paper- plastic peel FDA-cleared pouches. The sealed innerpouch should fit inside the otherpouch without folding. Packagingof the instrument must be pre-pared in a manner that pouchesshould be positioned so that plas-tic faces plastic and paper facespaper. Do not place the pouchedinstrument within a wrapped setsor containment devices.

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2. Load the sterilization pouch orwrapped tray in the sterilizer. Thetray or pouch should be positionedso that there is adequate circulationand penetration of steam, air removal,and condensate drainage.

3. Use the following KARL STORZvalidated parameters for steamsterilization.

• Pre-vacuum:

Pre-vacuum or high vacuum sterilizationconsists of four basic phases: a condi-tioning phase, an exposure phase, anexhaust phase and a drying phase. Theconditioning phase removes air from thechamber by pulling a vacuum and thenwarms the instruments by injecting steam.Sterilization phase occurs during theexposure phase when the chamber reachesthe set-point temperature of 270˚F (132˚C).The sterilization exposure phase in a pre-vacuum type of sterilizer is 4 minutes andminimum dry time of 20 minutes (refer tothe specific product instruction manualfor the validated dry time, if applicable).The exhaust phase removes the steamfrom the chamber. The following conditionshave been used to validate sterilizationprocedures for instruments in a prevacuumsterilizer.

Temperature: 270˚F (132˚C) Exposure Time: 4 minutes

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Steam Sterilization (Continued)

Note: Two and three piece Clickline in-struments may be sterilized assembledONLY in a 4 minute prevacuum steamcycle with luer port cap open. Temperature: 270˚F (132˚C) Exposure Time:4 minutes for all instruments

Note: The following conditions havebeen used to validate sterilization proce-dures for the Powershaver SL Multifunction(32K) hand pieces and its accessories: Temperature: 270˚F (132˚C) Exposure Time: 16 minutes

• Gravity Displacement:

Gravity displacement sterilization also con-sists of four basic phases, which are similarto the pre-vacuum type of sterilization.During the conditioning phase, steam isinjected into the chamber and the air isforced out through the drain. Sterilizationphase occurs when the temperature in thechamber reaches the set-point temperature.The steam is removed from the chamberduring the exhaust phase by allowing thesteam to escape down the drain. The ster-ilized items remain in the chamber at at-mospheric pressure to dry by the heatgiven off by the autoclave jacket. The fol-lowing conditions have been used to validatesterilization procedures for instrumentsusing a gravity displacement sterilizer: Temperature: 250˚F (121˚C) Exposure Time: 45 minutes

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Note: The following conditions havebeen used to validate sterilization proce-dures for the Powershaver SL Multifunctionhand pieces and its accessories:


CAUTION: Please note increased tem-perature and time exposure for this itemin Gravity Displacement.

• Immediate-Use (Flash) Steam Sterilization:

Note: Immediate-use sterilization is onlyrecommended for non-patient contactproducts.

Note: It is important to remember thatimmediate-use steam sterilization is notrecommended for powered instruments,unless specifically validated.

Immediate-use sterilization can be accom-plished in either a pre-vacuum or gravitydisplacement type of sterilization unit.Immediate-use sterilization has threephases 1) conditioning 2) exposure 3)exhaust, no dry-time. KARL STORZ hasvalidated immediateuse sterilization usinga pre-vacuum and gravity displacementunits for disassembled instruments withthe following conditions:

Gravity Displacement


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Steam Sterilization (Continued)

Pre-vacuum


STERRAD® Sterilization Systems (STERRAD 100S,NX and 100NX):The STERRAD® Sterilization Systems,manufactured by Advanced SterilizationProducts (ASP), utilize a synergism betweenhydrogen peroxide and low temperaturegas plasma to produce a rapid, lowtemperature, low moisture inactivation ofmicroorganisms. It is intended for terminalsterilization of properly cleaned, rinsedand dried reusable medical devices.

The STERRAD® NX System is a tabletop sterilizer with rectangular chambersize of 51.3L / 26L (usable). It utilizes thesame sterilant (vapor hydrogen peroxide)as the STERRAD® 100S. The major differ-ence is the vaporization system that ren-ders the hydrogen peroxide sterilantmore concentrated. The STERRAD NXSystem offers two cycles – Standardcycle at approximately 28 minutes andAdvanced cycle at approximately 38minutes. The STERRAD® NX is capableof sterilizing a single channel flexibleendoscope in the Advanced Cycle.

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The STERRAD® 100NX™ System is verysimilar to the current STERRAD® NXSystem. The STERRAD® 100NX™ Systemis a large sterilizer with rectangularchamber size of 152L / 93.4L (usable)and two cycles – a Standard cycle atapproximately 47 minutes and a Flexcycle at approximately 42 minutes.

WARNING:Only endoscopes speciallydesignated to be STERRAD® 100S/NX/100NX compatible are to be processedby these methods.

WARNING: Sterilize the KARL STORZPendulum Camera Heads with the slide-lock mechanism in the open position.

CAUTION: STERRAD® sterilization maycause cosmetic changes to the devicesthat do not necessarily impact the func-tionality of the device.

CAUTION: All instruments must be thor-oughly DRIED before loading into theSTERRAD® sterilizer. Loads containingmoisture may cause a cycle cancellation.

WARNING: Please note that there arerestrictions as to what may be sterilizedin the STERRAD® Sterilization Systemsbased on lumen size and materials.For appropriate lumen restrictions,please refer to the specific STERRAD®

Sterilization Systems User’s Guides.

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STERRAD® Sterilization (Continued)• Stainless steel and Titanium materials

are compatible with STERRAD®

Systems. Refer to the STERRAD®

Sterilization Systems User’s Guidesfor other compatible materials.

CAUTION: Use only STERRAD® com-patible instrument trays in the sterilizationchamber. These trays are specially designedfor vapor hydrogen peroxide sterilization.Refer to the instrument tray instructionmanual for compatibility information.

CAUTION: Use only FDA-clearedpolypropylene sterilization wraps and/orpolyolefin pouches. Do not use paperpouches or sterilization wraps containingwood pulp or cotton.

Note:The following may be sterilizedin STERRAD® 100NX “Standard” Cycle:

• KARL STORZ hand instruments thatare compatible with STERRAD®

100S/ NX sterilization.• Rigid/semi-rigid telescopes/instru-

ments with stainless steel channelswith inside diameter:• 0.7mm or larger whose totalchannel length is 500mm orshorter.** ASP conducted validation

testing for this lumen size usinga maximum of 10 lumens perload.

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• KARL STORZ has conductedadditional sterilization validationstudies for the 27010L/K and27011L/K Semi-Rigid Uretero-Renoscopes at ASP. KARL STORZrecommends sterilization of thisdevice in the validated STERRAD®

100NX “Standard” Cycle steriliza-tion process.

Note:The following may be sterilizedin STERRAD® NX “Standard” Cycle:

• KARL STORZ hand instruments thatare compatible with STERRAD®

100S sterilization

• Rigid/semi-rigid telescopes/instru-ments with stainless steel channelswith inside diameter:

• 1mm or larger whose total channellength is 150mm or shorter.**

• 2mm or larger whose total channellength is 400mm or shorter.**

Note: The following may be sterilizedin STERRAD® NX “Advanced” Cycle:

• Semi-rigid endoscopes/instrumentswith stainless steel channels withinside diameter 1 mm or largerwhose total channel length is500mm or shorter**.

** ASP conducted validation testingfor this lumen size using a max-imum of 10 lumens per load.

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STERRAD® Sterilization (Continued)

• KARL STORZ has conductedadditional sterilization validationstudies for the 27011L/K Semi-Rigid Uretero-Renoscopes at ASP.KARL STORZ recommends ster-ilization of these devices in thevalidated STERRAD® NX “Ad-vanced” Cycle sterilization process.

1. Place the instruments in a STERRAD®

compatible instrument tray or enclosein polyolefin pouches.

2. Place a STERRAD® indicator strip ineach tray and pouch.

3. Double wrap the sterilization tray withtwo single layers of FDA-clearedpolypropylene wrap, using a sequentialdouble wrapping technique.

4. Load the STERRAD® sterilizer, arrang-ing the items such that the hydrogenperoxide plasma can surround them.Do not allow any items to touch thewall of the sterilizer.

5. Please refer to the STERRAD® Steril-ization Systems User Guides fordetailed instructions for use of anySTERRAD® unit, ASP’s STERRAD®

Sterility Guide (SSG) at www.ster-radsterilityguide.com, or contact ASPCustomer service at (888) 783-7723.

6. Please contact KARL STORZ Endo-scopy-America, Inc. for questions aboutSTERRAD® SYSTEMS compatibility.

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Table 2

STERRAD Sterilization Systems Lumen Claims

STERRAD®100S

(US CLAIMS) #

Claims (US)

Inside Diameter

Length

Special R

equirem

ents

Plastics

6 mm or larger

310 mm or shorter

Stainless Steel

1 mm or larger

#125 mm or shorter

Lumens

2 mm or larger

#250 mm or shorter

3 mm or larger

#400 mm or shorter

#100S = 10 stainless steel lum

ens max. per load

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STERRAD®NX and 100N

X System (WORLDWIDE CLAIMS) ##

Worldwide Claims

Inside Diameter

Length

Special Requirements

PE/PTFE Tubing

1 mm or larger

350 mm or shorter

NX Only: Process in Standard Cycle

1 mm or larger1000 mm or shorterFor N

X: Process in Advanced Cycle

Flexible

Single channel flexible endoscopes only

Endoscopes with

1 mm or larger

850 mm or shorter

(NX = Advanced Cycle; 100NX = Flex Cycle)

PE/PTFE Lumen

1 mm or larger

150 mm or shorter


Stainless Steel

2 mm or larger

400 mm or shorter


Lumens

1 mm or larger

500 mm or shorter

NX Only: Process in Advanced Cycle

0.7 mm or larger500 mm or shorter

100N

X Only: Process in Standard Cycle

##NX/100N

X = 10 stainless steel lum

ens max. per load Note: D

ata provided by ASP.

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STERIS® Amsco V-PRO™ Sterilization SystemsThe STERIS® Amsco V-PRO™ Low Tem-perature Sterilization Systems from STERIS®utilizes vaporized hydrogen peroxide (nogas plasma) to inactivate microorganisms.The STERIS® Amsco V-PRO™ Systems arelarge sterilizers with rectangular chambersize of 136L. They are intended for terminalsterilization of properly cleaned, rinsed,and dried reusable medical devices.

The Amsco V-PRO 1 Low TemperatureSterilization System performs one (1) pre-programmed sterilization cycle. The cycleparameters are equivalent to V-PRO 1 Plus“Lumen” Cycle. The VPRO 1 Cycle can ster-ilize devices, including rigid endoscopes,with single-stainless steel lumen with:

• An inside diameter of 3 mm or largerand a length of 400 mm or shorter



The Amsco V-PRO 1 Plus Low Tempera-ture Sterilization System performs two (2)pre-programmed sterilization cycles.

• Lumen Cycle -- The Lumen Cycleis identical to the Amsco V-PRO 1sterilization cycle.

• Non Lumen Cycle

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STERIS® Sterilization (Continued)

The Amsco V-PRO maX Low TemperatureSterilization System performs three (3)pre-programmed sterilization cycles.

• Lumen Cycle

• Non Lumen Cycle

• Flexible Cycle

CAUTION: STERIS® Amsco V-PRO™sterilization may cause cosmetic changesto the camera head assembly that doesnot necessarily impact the camera’s func-tionality.


CAUTION: KARL STORZ recommendsthe use of one cleaning agent and onesterilizationmethod to prevent the unknownrate of material degradation due to materi-al-chemical interactions from variouscleaning and sterilization processes.

CAUTION: Instruments must be thor-oughly dried before loading into the AmscoV-PRO™ sterilization chamber. Loadscontaining moisture may cause a cyclecancellation.

CAUTION: Use only STERIS® AmscoV-PRO™ compatible instrument trays inthe sterilization chamber. These trays arespecially designed for vapor hydrogenperoxide sterilization.

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CAUTION: Use only FDA-clearedpolypropylene sterilization wrap and poly-olefin pouches. Do not use paper pouchesor sterilization wraps containing woodpulp or cotton.

1. Place the instruments in V-PRO com-patible instrument trays or enclosein polyolefin pouches.

2. Double wrap the sterilization tray withtwo single layers of FDA-clearedpolypropylene wrap, using a sequen-tial double wrapping technique.

3. Place V-PRO indicator strips in alltrays and pouches.

4. Load trays or pouches into theSTERIS® Amsco V-PRO™ sterilizer,arranging them so that the hydrogenperoxide vapor can surround it. Donot allow any items to touch the wallof the sterilizer.

5. Please consult the STERIS® AmscoV-PRO™ Sterilization System Oper-ator’s Manual for detailed instructionsfor use or contact STERIS® CustomerService at (800) 548-4873.

6. Please contact STERIS® for the mostup to date information regarding ster-ilization with the STERIS® Amsco V-PRO™ Sterilization Systems.

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STERIS® Sterilization (Continued)

STERIS® SYSTEM 1E Liquid Chemical Sterilant Processing System

WARNING: The STERIS® SYSTEM 1ESystem is only approved for liquidchemical sterilization of cleaned, im-mersible, and reusable critical and semi-critical heat-sensitive medical devices.


Please consult the STERIS® SYSTEM 1EOperator Manual and specific Quick Con-nect Processing Instructions for properliquid chemical sterilization processingand use of the Quick Connect kit andcompatible STERIS® trays. Endoscopeswith channels may only be sterilized usingthe proper Quick Connect Kit. Endoscopeswithout channels may be sterilized usingSTERIS® SYSTEM 1E.

Refer to the STERIS® Corporation’s websitefor SYSTEM 1E Device & Quick ConnectFinder.

http://www.steris.com/products/quickcon-nects/

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Please consult the appropriate KARLSTORZ manual or contact STERIS® cus-tomer service at (800) 548-4873 to identifythe appropriate Quick Connect Kit for anendoscope. Various flexible and semi-rigid endoscopes have SPECIFIC QuickConnect Kits.

High Level Disinfection (HLD)Instructions for KARL STORZInstruments:

WARNING: High level disinfection(minimum requirement) is recommendedONLY for “semi-critical” instrumentswhich come into contact only with intactmucous membranes or non-intact skin.

High level disinfection is NOT recom-mended for “critical” instruments tobe used for Hysteroscopy, Neuroen-doscopy, Arthroscopy, or Laparoscopy.

WARNING:Refer to CIDEX OPA labelingfor important contraindications regardingthe use of CIDEX OPA on instrumentsthat will be used for patients with bladdercancer.

WARNING: Process the KARL STORZPendulum Camera Heads with the slide-lock mechanism in the open position.

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High Level Disinfection (Continued)

CAUTION: Resert XL HLD is NOT com-patible with Brass, Chrome-Plated Brass,Copper, Monel S, Nickel-Plated Steel,Silver, and Tungsten Carbide.

CAUTION: Before disinfection, the instru-mentsmust be thoroughly cleaned, rinsed,and dried if applicable.

CAUTION: To avoid damage to the in-struments, do not immerse the devicesin disinfectant solution for longer thanone hour.

CAUTION: To avoid damage, ensure thatresectoscope working elements are com-pletely dry after disinfection and beforeuse in the surgical field.

CAUTION: Do not immerse eyepiecesection of HAMOU rigid telescopes.

CAUTION: KARL STORZ recommendsthe use of one cleaning agent and onesterilization method to prevent the unknownrate of material degradation due to ma-terial-chemical interactions from variouscleaning and sterilization processes.

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Manual HLD KARL STORZ instruments may be chemicallydisinfected (manual) using high-level dis-infectant solutions containing a 2.4% con-centration of glutaraldehyde (e.g. CIDEX®,a 14-day glutaraldehyde solution) or 0.55%ortho-phthalaldehyde (e.g. CIDEX OPA, a14-day solution) or 2.0% concentration ofhydrogen peroxide (e.g. Resert XL HLD).

KARL STORZ does not recommend theuse of CIDEX® PLUS or other 28-dayroom temperature glutaraldehyde solutionsfor manual high level disinfection, as theycontain high concentrations of surfactants,which may dry and crystallize on the en-doscopes if they are not thoroughly rinsed.The crystalline form of the surfactant canbecome conductive to electricity providinga pathway for arcing. Glutaraldehyde so-lutions with concentrations greater than2.4% should be avoided, as a higherpercentage of glutaraldehyde may dam-age the instruments.

Note: Refer to the “Water Quality Require-ments” Section.

1. Prepare the disinfecting solution for use:

2.4% Glutaraldehyde Solution (e.g. CIDEX®)

• Activate the glutaraldehyde solu-tion by adding the entire contentsof activator vial to the solution inthe container. Shake well. Activated

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solution immediately changescolor to green, thereby indicatingthe solution is ready to use. UseCIDEX (Activated Dialdehyde)Solution Test Strips to verify thesolution is above the minimumeffective concentration (MEC).Test the solution prior to eachuse. Do not use activated solutionbeyond stated 14 day reuse life.Record the date of activation andthe expiration date on the container.

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

• No activation is necessary. UseCIDEX (Activated Dialdehyde)Solution Test Strips to verify thesolution is above the minimumeffective concentration (MEC).Test the solution prior to eachuse. Record the date the solutionwas poured out of the originalcontainer.

2.0% Hydrogen Peroxide (e.g. Resert XL HLD)

• No activation is necessary. UseVerify® Chemical Monitoring Stripfor Resert XL HLD Solution to con-firm hydrogen peroxide concen-tration before each use. Recordthe date the solution was pouredout of the original container.

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2. Place the instruments into a plasticcontainer containing the HLD solution.Ensure that the instruments are fullyimmersed and remove any air bubblesadhered onto the surfaces of instruments.Fill any lumen with the HLD solution.

3. Utilize the following disinfection con-ditions to achieve manual high-leveldisinfection:

2.4% Glutaraldehyde Solution (e.g. CIDEX®)

• Immerse in the solution for 45 minutes at 25˚C (77˚F).

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

• Immerse in the solution for 12 minutes at 20˚C (68˚F).

2.0% Hydrogen Peroxide (e.g. Resert XL HLD)

• Immerse in the solution for 8 minutes at 20°C (68°F).

4. After disinfection is completed, removethe instruments from the disinfectantsolution and rinse the instrumentsby completely immersing it in a largevolume of sterile water (e.g. two gallons).Keep the instruments totally immersedfor a minimum of one (1) minute induration. Flush a minimum of 500 mLof water through all lumens to removethe cleaning solution. Discard thewater and repeat with fresh water fora total of three immersion rinses.

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Note: Please refer to the disinfectantmanufacturer’s Instructions-for-Use formore detailed information regarding theuse of the disinfectant solution, includingproper rinsing techniques.

5. Dry the instruments with a lint-freesterile cloth or dry, oil-free compressedair (<5 psi). To thoroughly dry the in-strument and irrigation channels,flush the channels with 70% isopropylalcohol. Then flush the channel withdry, oil-free compressed air (<5 psi).

CAUTION: Light transmission could beconsiderably impaired due to incompleterinsing. Any disinfectant or cleaning solutionresidues on the light post could burn intothe light post when the fiber optic lightcable is connected.

Automated HLD

STERIS Reliance EPS®(High Level Disinfection):The Reliance EPS is intended for highlevel disinfection of cleaned, immersible,reusable, heat-sensitive, semi-criticalmedical devices.

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Please consult the STERIS® OperatorManual and Endoscope Quick ReferenceGuide for the Reliance EPS EndoscopeProcessing System for proper Flow Unit,listing of safety precautions, warningsand cautions, or contact STERIS CustomerService at (800) 548-4873.

MEDIVATORS AER Systems(High Level Disinfection):Please refer to the Medivators’ ReprocessingSystems Hookup Application Guide or contactMedivators Technical Support at (800) 444-4729. Refer to the Minntech Corporation’swebsite to identify the correct MedivatorsAERs Hookup(s) for reprocessing of thespecific KARL STORZ Endoscopes.

http://www.minntech.com/products-and-services/endoscope-reprocessing/hookupshttp://www.minntech.com/medivators/hookuplookup/

CAUTION: Do not mix reprocessingmethods using peracetic-based high leveldisinfection agents with hydrogen perox-ide-based agents.The Medivators AER Systems are intendedfor high level disinfection of cleaned, im-mersible, reusable, heat-sensitive, semi-critical medical devices.

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Mediavators AERs

Description

CER-1

(MV-1)

CER-1

(MV-2)

DSD /

SSD

Advantage

Multi-Use

DSD

Edge

Advantage

Plus

Recom

mended

HLD

Agents

CIDEX®, C

IDEX®OPA

or Rapicide

Rapicide PA

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.7171 Millcreek Drive

Mississauga, Ontario, Canada L5N 3R3Telephone: (905) 816-4500Toll Free: (800) 268-4880Telefax: (905) 816-4599

PI-000035P-22.0 (8/16)

CAUTION: Federal (USA) law restrictsthis device to sale by or on the order ofa Physician.

General Reprocessing Instructions for KARL STORZ Products ...

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