Olympus System Guide

8/3/2019 Olympus System Guide

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SYSTEM-RELATED

INSTRUCTION MANUAL

SYSTEM GUIDE ENDOSCOPY





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System GuideW7.052.801

CONTENTS

1 Introduction .......................................................................51.1 Potential Hazards and Signal Words ........................81.2 Symbols ....................................................................91.3 Quality Management...............................................10

2 Use of Endoscopic Equipment ......................................112.1 General Policy ........................................................11

2.2 Inspection Before Each Use ...................................132.3 Wiring Video Equipment .........................................172.4 Video Equipment: Troubleshooting .........................19

3 Energetic Applications ................................................... 253.1 Safety Precaution for Electro-Medical Equipment .. 253.2 Light ........................................................................293.3 HF Surgery .............................................................333.4 Laser Surgery .........................................................42

4 Indications and Contraindications ................................454.1 Arthroscopy.............................................................454.2 ENT (Ear, Nose, Throat) .........................................454.3 Hysteroscopy ..........................................................464.4 Laparoscopy/Thoracoscopy ....................................484.5 Urology ...................................................................52



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System Guide W7.052.801

5 Reprocessing ..................................................................555.1 General Policy ........................................................555.2 Reprocessing Processes and Agents .....................585.3 Health and Safety at Work ......................................605.4 Decontaminating the Surface of Electrical Units .... 615.5 Preparation for Reprocessing at the Point of Use ... 625.6 Manual Cleaning .....................................................655.7 Ultrasonic Cleaning.................................................725.8 Manual Disinfection ................................................ 735.9 Automatic Cleaning/Disinfection .............................795.10 Maintenance ...........................................................825.11 Steam Sterilization .................................................. 85

5.12 Gas Sterilization ......................................................905.13 Other Sterilization Processes .................................935.14 Storage and Handling ............................................. 95

6 Service .............................................................................996.1 The Olympus Organization .....................................996.2 Repairs .................................................................100

7 Appendix........................................................................103



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1 Introduction

Olympus Instruction Manuals have been prepared toprovide the user with all the necessary knowledge aboutthe safe use of Olympus endoscopes and their relatedaccessory equipment.For further questions about how to use the products,about the products’ safety, or about this or other Olympusmanuals, feel free to contact your local Olympusrepresentative or visit our Web site atwww.olympus-owi.com

Instruction Manuals.Olympus provides two different types of instructionmanuals:- A system-related instruction manual, the “Olympus

Endoscopy System Guide” (this manual)- Aproduct-specicinstructionmanual

Olympus Endoscopy System Guide.

The system-related instruction manual “OlympusEndoscopy System Guide” combines information on thosetopics that apply to virtually all instruments. Therefore, theOlympus Endoscopy System Guide must be consideredas part of all instruction manuals. It is supplied with everyOlympus telescope.The System Guide applies to:- All products manufactured by Olympus Winter & Ibe

in Germany. These products are labelled “OLYMPUSGermany”.

- Products distributed by Olympus Winter & Ibe, Germany,whichareaccompaniedbyaproduct-specicinstructionmanual that references the Olympus Endoscopy SystemGuide.



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Product-Specic Instruction Manuals.Olympus products are supplied with their own product-specicinstructionmanual,whichgivealldetailsnecessary

for the use of the product (only very few products aredelivered without an instruction manual as they are self-explanatory).Insomeaspects,theproduct-specicinstructionmanualsonly make reference to the System Guide. In these cases,all the related information given in the System Guide isapplicable to the product.If the information given in the System Guide is notapplicabletoacertainproduct,specicinformationisgiven

intheproduct-specicinstructionmanual.

Latest Version of the Olympus Endoscopy System Guide.Due to a continuous development in technology, thecontent of the Olympus Endoscopy System Guide isregularly updated. To make sure that you use the mostrecent version of the Olympus Endoscopy System Guide,check our Web site (www.olympus-owi.com). The version

number of any issue of the Olympus Endoscopy SystemGuide can be found on the bottom of its back cover. Itis the number following the order number (for example:W7.052.800 12.1_01/10).

Carefully Read all Instruction Manuals.Beforeuse,carefullyreadtheproduct-specicinstructionmanual, the Olympus Endoscopy System Guide (thismanual), and all instruction manuals pertaining to additionalequipment used in the procedure.Follow all instructions given in these manuals.Failure to understand these instructions may result in:- Death or severe injury to the patient- Severe injury to the user- Severe injury to a third party- Damage to the equipment



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Use of Instruction Manuals.Instructionmanualscontainvaluablespecications,care,and problem-solving information which will help ensure safe

and effective operation of the equipment. Keep instructionmanuals in a safe, accessible location.

The Olympus Endoscopy System Guide in Other Languages.The Olympus Endoscopy System Guide is available in thefollowing languages:Български .........................................................W7.052.815Česky .................................................................W7.052.811

Dansk .................................................................W7.052.807Deutsch ..............................................................W7.052.802Eesti keeles ........................................................W7.052.821Ελληνικά ............................................................W7.052.812English (international version) ............................W7.052.800English (for use in the U.S.) ...............................W7.052.801Español ..............................................................W7.052.803Français .............................................................W7.052.804Italiano ...............................................................W7.052.806

Latviešu..............................................................W7.052.820Lietuviųk............................................................W7.052.822Magyar ...............................................................W7.052.817Nederlands.........................................................W7.052.810Norsk (Bokmål) ................................................. W7.052.818Polski .................................................................W7.052.823Português...........................................................W7.052.805Română .............................................................W7.052.824Русский .............................................................W7.052.814Slovensko...........................................................W7.052.819Suomi .................................................................W7.052.809Svenska .............................................................W7.052.808日本語 ................................................................W7.052.813中文（简体中文） ..............................................W7.052.816中文（台灣，中華民國） ...................................W7.052.826한국어 ................................................................W7.052.827



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For a brochure in any language, contact an Olympus Salesrepresentative, or refer to our Web site atwww.olympus-owi.com.

1.1 Potential Hazards and Signal Words

Safety is the most important issue when using medicaldevices. This means safety for the patient as well as for themedical personnel.Therefore Olympus manuals include safety information

which help the user to identify potential hazards and avoidthem. Olympus instruction manuals highlight potentialhazards by using three signal words: Danger, Warning,and Caution. In addition, the signal word Note has beenintroduced for helpful information.

DANGER! Indicates an imminently hazardous situation which, if notavoided, may result in death or serious injury.

WARNING! Indicates a potentially hazardous situation which, if notavoided, could result in death or injury.

CAUTION! Indicates a potentially hazardous situation which, if notavoided, may result in minor or moderate injury.This signal word may also be used to highlight unsafepractices or potential equipment damage.

NOTE Indicates additional helpful information.



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1.2 Symbols

Potential hazards, mandatory actions, prohibitions, and

user actions are illustrated using the same symbol shapesthroughout all instruction manuals.

Hazard Alert.An equilateral triangle is used to convey hazard alertmessages, regardless of their hazard level. Hazard levelis conveyed by use of the appropriate signal word asdescribed above.

Mandatory Actions.A solid color circle is used to signify a mandatory action.

Prohibited.A circle with a 45° diagonal slash from upper left to lowerright is used to indicate prohibition.

User Actions.A bullet at the beginning of a sentence indicates a requireduser action.



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1.3 Quality Management

Olympus Winter & Ibe has implemented a quality

management system. The standards and directives listedbelow are the basis of this quality management system (intheir respective latest approved version):- ISO 17664- EN ISO 9001- EN ISO 13485- Directive 93/42 EEC, Annex II, Art. 3 (“Medical Device

Directive”) of the Council of the European Community- “Good Manufacturing Practices” of the US Food and Drug

Administration (FDA)- Canadian Medical Devices Assessment System

(CMDCAS)

Certication.Since September 1995 Olympus Winter & Ibe are allowedto label their products with the CE mark according todirective 93/42 EEC. Therefore, the quality managementsystemisregularlyauditedandcertiedbyanindependent

notiedbody(TÜVRheinland).Since May 2001, Olympus Winter & Ibe has implemented acertiedenvironmentalmanagementsystemaccordingto DIN EN ISO 14001.



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2 Use of Endoscopic Equipment

2.1 General Policy

User Qualication.The user of endoscopic equipment must be a physician ormedical personnel under the supervision of a physician.Theusermusthavereceivedsufcienttraininginclinicalprocedures. Olympus instruction manuals do not explain ordiscuss clinical procedures.

Spare Equipment.Always have spare equipment available in order to replacethe equipment in case of a malfunction.

WARNING! Infection Control Risk with Reusable Equipment.Properlyreprocessallreusableequipmentbeforerstand each subsequent use following the instructions

in this Endoscopy System Guide and in the product-specicinstructionmanual.Improperand/orincompletereprocessing can cause infection of the patient and/ormedical personnel.



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WARNING! Infection Control Risk with Sterile, Single-Use Equipment.

The equipment is delivered in a sterilized condition.Use only if the package is undamaged. Only open thepackage immediately before use. Do not use the equipmentafter its expiration date (if an expiration date is given).Dispose of expired equipment according to national andlocal laws and guidelines.

Instrument Compatibility.The combinations of equipment and accessories that can

be used with a certain product are listed in its product-specicinstructionmanual.Thesectionisheaded“Compatible Components”.New products released after the introduction of a productmay also be compatible for use. For details, contactOlympus.

WARNING! Risk of Injury or Equipment Damage.

Using incompatible equipment can result in patient injuryand/or equipment damage.If combinations of equipment other than those listed inthe “Compatible Components” section are used, the fullresponsibility is accepted by the user.



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2.2 Inspection Before Each Use

Before each use, perform the following inspection in

additiontothatdescribedintheproduct’sproduct-specicinstruction manual.

General Inspection.• Theproductmustbefreeofdamage(e.g.,dents,cracks,

bends).• Theproductmustbefreeofdebris.• Theproductmustbefreeofresidualcleaningagentsor

disinfectants.

• Makesurethatnopartsaremissingorloose(e.g.,sealing rings, sealing caps).

• Makesurethatconnectingelementsbetweeninstrumentsfunction properly.

• Inspectworkingchannelsforfreepassage.• Makesurethatallinstrumentparts/modulesofan

instrument system are assembled correctly and properlyxed(e.g.,electrodes,knives,etc.).

Inspecting Telescopes.• Inspectfordebrisontheobjectivewindow,theocular

window and the light-guide connector.• Thetelescope’simagemustnotbecloudy,outoffocusor

dark.• Makesurethatthereisefcientlighttransmissionfrom

the light-guide connector to the distal end. If in doubt,compare the telescope’s light transmission with that of anew telescope.



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Inspecting Light-Guide Cables.• Makesurethatefcientlighttransmissionisobtained.

If in doubt, compare the light-guide cable’s light

transmission with that of a new light-guide cable.• Inspectforcutsorotherdamagestothecable’soutersleeve.

• Visuallyinspecttheconnectortobepluggedintothelightsource. Make sure that the cover glass is not damaged.

Inspecting HF Cables.• Makesurethatthecableisnotbroken.• Makesurethattheinsulationisnotdefective.• Makesurethatconnectorsarenotdamaged(e.g.,dents,

cracks, bents) and free of corrosion.



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Inspecting Electrodes.• Makesurethatcontactsurfacesarefreeofdamage,

corrosion, and/or wear.

• Makesurethattheinsulationisnotdamaged.• MakesurethattheHF-resectionelectrodesaresecurelyattached. To do so, hold the working element in onehand. With the other hand, hold the electrode guidingtube. Pull slightly at the electrode.

• Makesurethattheelectrodemovessmoothlyandfreelywithin the assembled instrument.



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Inspecting Hand Instruments.• Makesurethatthejawsandthehandlemovefreelyand

are properly attached to the instrument.

• Makesurethattheelectrode’sproximalpartisnotbent.• Makesurethattheshaft’sinsulationisnotdamaged.• Makesurethatthejawsinsertcanbeinsertedsmoothly

in the handle.• Testscissorsforcuttingability.• Makesurethatthesealingcapisnotdamaged(e.g.,

cracks).



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2.3 Wiring Video Equipment

Cable Types.There are several ways to connect video equipment.Common cable types are:- BNC- Y/C- RGB- Cinch- Digital

A BNC cable is a two-pole coaxial cable. The color,luminance and synchronizing signals are transmittedthrough this cable.

A Y/C cable is a four-pole cable. The luminance signal istransmitted separately from the other signals. Thereforethe transmission quality is higher. Y/C cables are used forS-VHS and Hi-8 systems.

A RGB cable is an eight-pole cable. Color signals for red,green, blue, and the synchronizing signal are transmittedseparately. RGB wiring features the highest transmissionquality.

A cinch cable is a two-pole cable. It is used for transmittingaudio signals.

Digital cables transmit video and audio signals as digitaldata. There are several different types of plug connectorsand transmission protocols.

The choice of cables depends on the interfaces featured bythe individual ancillary video equipment.



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Principles of Wiring.There are a few principles for wiring video equipment.1. Always connect the OUT connector of the source unit to

the IN connector of the receiving unit.

2. If a unit’s terminating impedance is in manual mode,check the IN and OUT connectors of the unit.If the IN connector is occupied and the OUT connector is

free, switch on the terminating impedance.If IN and OUT connectors are occupied, switch off theterminating impedance.

3. Make sure that all cables are connected to a unit at bothends. If a cable cannot be connected at both ends, donot use the cable.

4. Always use the connection with the highest transmissionquality possible. Transmission quality decreases in thefollowing order:RGB, Y/C, BNC

5. If a cable connection is used for documenting signals(VCR, video printer), use the connection with the highestpossible transmission quality.For example:- Connect a printer via a Y/C cable.- Connect a monitor via a BNC cable.

VIDEO OUT

VIDEO OUT

VIDEO OUT

VIDEO IN

VIDEO IN

LINE A

VIDEO OUT

LIGHT

LIGHT

IN OUT

LINE B

IN OUT

VCR

Light Source

Camera Control Unit

Video Printer

Monitor 1

LINE A

IN OUT

LINE B

IN OUT

Monitor 2



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6. If possible, avoid passing the signal through severalunits. If available, use multiple source connectors of oneunit to connect other equipment directly.

7.Whenusingendoscopeswithberbundleoptics(e.g.,berscopes,ureteroscopes),Y/CorRGBwiringisrecommended to prevent moiré patterns.

2.4 Video Equipment: Troubleshooting

Always perform a functional check of the imaging

equipment before each use. Take the following steps if anyirregularities are observed:

No Image Appears on the Monitor Screen.• Makesurethatthecameracontrolunitandmonitorare

connected to a power supply.Connect to a power supply if necessary.

• Dothepowerswitch(ON)ofthecameracontrolunitandthe monitor illuminate?

If not, check the fuses.If necessary, replace the fuses.

• Checkwiringofcameracontrolunitandmonitor: Is the camera control unit’s VIDEO OUT connectorconnected to the monitor’s VIDEO IN connector?

• Ifthemonitorfeaturesaselectorformorethanonevideosignal source:Check the selector switch (e.g., LINE A, LINE B).Select the appropriate video signal source.

• Setallmonitorsettings(brightness,color,contrast)tothedefault values.

• Makesurethatthecamerahead’sconnectingcableissecurely connected to the camera control unit.

• Replacethevideocablebetweenthecameracontrolunit and the monitor with another cable to rule out cabledefects.

• Ifthecameracontrolunitfeaturesacolorbartestchart,



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switch it on to test the monitor.If the color bars do not appear on the monitor screen,contact an authorized Service Center for repair.

“Running” or “Rolling” Image on the Monitor Screen.• TurntheV-HOLDknobonthemonitor’srearpaneluntil

the image becomes stable.

Blue Cast or Green Cast Image.• Humiditymayhaveintrudedintothecamerahead’s

connecting plug.Carefully dry the camera head at 60 °C for 30 minutes.

Image Disappears Temporarily.• Makesurethatallcablesandconnectorsaresecurely

connected.• Visuallyinspectallcablesforexternaldamage.

Image on the Monitor Screen Appears Dark.• Makesurethatthemonitor’sbrightnessadjustmentis

appropriate.If necessary, readjust the brightness.

• Checktheopticalsurfacesofthelight-guidecableandthe telescope’s light-guide cable connectors for debris.If necessary, clean the optical surfaces with a cottonswab moistened in 70 % alcohol (e.g., ethanol,isopropanol).

• Replacethelight-guidecablewithanewonetoruleoutlight-guide defects.

• Checktheintensitysettingofthelightsource. If necessary, readjust the intensity setting.

G

B



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• Checkthelightsource’slamp. If the light source has a lamp life counter: Has the lamplife expired?

If necessary, replace the lamp.If the light source has an emergency lamp: Has theemergency lamp been switched on?If necessary, replace or switch on the main lamp.

• Ifthelightsourcehasanylters,makesurethattheyhave been switched off.

• ContactanauthorizedServiceCenter.

Color Reproduction not Satisfying.

• Setallmonitorsettings(brightness,color,contrast)tothedefault values.

• Iftheterminatingimpedanceofanyoftheunitsintheimaging chain is in manual mode, check the IN and OUTconnectors of the unit.If the IN connector is occupied and the OUT connector isfree, switch on the terminating impedance. If the IN andOUT connectors are occupied, switch off the terminatingimpedance.

• Ifthemonitorfeaturesaselectorforcolortemperature,select 6500 Kelvin.

• Trytoadjustthecolorreproductionusingthecameracontrol unit’s red and blue balancing functions.

• Ifthisdoesnothelp,performawhitebalanceonthecamera.Set the camera control unit’s red and blue balancingfunction to the default setting.Point the endoscope’s distal end to a white surface at adistance of about 30 mm, with the light source turned on.Use only matte white paper when performing thisinspection. Do not use shiny paper. Do not use paper withcolor cast.Make sure that the endoscope’s illumination does notinterfere with any lighting in the operating room whileperforming a white balance.Perform a white balance for the camera control unit.



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Image on the Monitor Screen Out of Focus.• Adjustthefocusbyturningthevideoadapter’sfocusing

ring.

• Checktheconnectionofthetelescope,videoadapterandcameraheadforproperattachmentandsecurexation.• Checktheopticalsurfacesofthetelescope,video

adapter, and camera head for residual debris andhumidity.If necessary, clean the optical surfaces with a cottonswab moistened with 70 % alcohol (e.g., ethanol,isopropanol).If necessary, dry optical surfaces using an appropriate,

lint-free cloth.• Checktheimagingofthetelescopeitself.

Disconnect the telescope from the video adapter and lookthrough the eyepiece.If the telescope itself is out of focus, contact anauthorized Service Center.

• Checktheimagingofthecameraheaditself. Disconnect the telescope from the video adapter.Leave the video adapter attached to the camera head.

Check the image appearing on the monitor screen now.If this image is out of focus, contact an authorizedService Center.



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Image on the Monitor Screen Out of Center.• Disconnectthetelescope,videoadapterandcamera

head.

• Makesurethatthetelescope’seyepiececup,thevideoadapter and the camera head’s connecting thread are notdamaged.

• Makesurethattheeyepiececupissecurelyxedtothetelescope.

• Makesurethatthevideoadapter’sxationmechanismsare not damaged and work properly.

• Connectthetelescope,videoadapterandcamerahead. Makesurethatallcomponentsaresecurelyxed.

• Iftheimageisstilloutofcenter,contactanauthorizedService Center.



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3 Energetic Applications

3.1 Safety Precaution for Electro-Medical Equipment

1. General.Thefollowinginstructions,basedontheNoticationNo. 495 issued by the Pharmaceutical and Supply Bureauof the Ministry of Health and Welfare, Japan, June 1, 1972,describe general precautions which should be taken in the

use of electro-medical equipment to ensure the safety ofthe patient, operator and surroundings.Inregardwithspecicsafetyprecautionsforparticulartypes of equipment, refer to the individual operationmanuals.

2. Installation.1.The equipment should not be installed in a location on

which liquids may splash.

2. Avoid environmental conditions that are likely tobe adversely affected by atmospheric pressure,temperatures, humidity, ventilation, sunlight, dusty, saltyor sulfureous air, etc.



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3. Exercise care so that the equipment is neither inclinednor subjected to vibration and impacts. (Including duringtransportation.)

4. Never install and operate the equipment where there is ariskofammablegases.

5. The AC mains to which the equipment is connectedshould supply a power appropriate for the inputfrequency, rated voltage and amperage of theequipment.

6. Check the conditions of batteries (discharge, polarity,etc.)

7. Earth the equipment effectively.

3. Before Use.1. Check electrical contacts of switches, polarity, dial

setting, indicators, etc. and make sure that theequipment functions properly.

2. Make sure that the equipment is earthed effectively.3. Make sure that all cords are connected correctly and

securely.



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4. Consideration should be taken if the equipment is usedin conjunction with other instruments so that inaccuratediagnosis or a hazard will not result.

5. Check the external circuit directly connecting to thepatient.6. Check the batteries.

4. During Use.1. A prolonged use or a dosage more than necessary for

diagnosis and treatment may compromise patient safety.2. Keep an eye continuously on the equipment at large as

well as the patient for abnormality.

3. If any abnormality with the equipment or the patient isdetected, take appropriate measures, e.g. by stoppingthe equipment in such a matter that it does not impair thepatient safety.

4. Pay attention so that the patient does not come intocontact with the equipment.

5. After Use.1. After setting control switches, dials, etc. back to the

home position in accordance with the procedures asprescribed, turn off the power switch.

2. When unplugging the connector, do not yank at the cord.Grasp the plug and pull to disconnect.

3. Storage.a. The equipment should not be stored in a location on

which liquids may splash.b. Avoid environmental conditions that are likely to

be adversely affected by atmospheric pressure,temperatures, humidity, ventilation, sunlight, dusty, saltyor sulfereous air, etc.

c. Exercise care so that the equipment is neither inclinednor subjected to vibration and impacts.

d. Do not store the equipment where there is a risk ofammablegases.

4. After accessories, cords, leads, etc. have been cleaned,arrange them neatly, then put in storage.



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5. During storage keep the equipment clean and ready fornext use.

6. Service and Maintenance.1. If any failure has developed, leave repairs to thespecialist. Attach appropriate information to the defectiveequipmentandcallqualiedservicepersonnel.

2. The user should not modify the equipment.3. Maintenance and inspection.a. Inspect the equipment and accessories periodically.b. When using the equipment after an extended period of

time, make sure it functions normally and safely.

Forspecicsafetyprecautionsofparticularequipment,refertotheproduct-specicinstructionmanual.



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3.2 Light

Energy Emission of Light Sources.

Light sources emit large amounts of light energy andthermal energy.As a result:- The light-guide connector and the telescope’s distal end

become extremely hot.- The light energy is concentrated in a relatively small area.

Risks Related to Light Sources.- Thermal injury to the patient’s tissue (e.g., from prolonged

exposure to the intense illumination in cavities with smalllumens, or if the telescope’s distal end is placed intoclose proximity with the tissue).

- Burns to the patient’s or user’s skin.- Burns or thermal damage to surgical equipment (e.g.,

surgical drapes, plastic materials, etc.).

Safety Precautions.• Avoidprolongedexposuretointenseillumination.

• Usetheminimumlevelofilluminationnecessarytosatisfactorily illuminate the target area.

• Donotplacethetelescope’sdistalendorthelight-guideconnectoronthepatient’sskin,onammablematerials,or on heat-sensitive materials.

• Donottouchthetelescope’sdistalendorthelight-guideconnector.





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Interferences of Light Sources with Imaging Equipment.Video systems feature different brightness control

functions, such as an electronic shutter and an auto focusfunction.These mechanisms control the brightness of the videoimage on the monitor screen but do NOT control the lightsource’s output.In the case of improper settings of the camera and lightsource, the light source might be set to full power output,although this is not visible on the monitor screen.Such improper settings lead to enhanced heat emission at

the telescope.For further information on the proper connection of lightsourcesandvideosystems,refertotheproduct-specicinstruction manuals.



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Testing the Light Source’s Brightness Control Function.• Movetheendoscope’sdistalendtowardsanobject.

The light emission from the telescope’s distal end mustdecrease.

• Movetheendoscope’sdistalendawayfromanobject. The light emission from the telescope’s distal end mustincrease.



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3.3 HF Surgery

An electrical current applied to biological tissue generates

three effects:- a thermical effect, generating heat- a Faraday effect, stimulating nerves and muscles- an electrolytical effect, causing movement of ions

Effects of HF Current.In HF surgery, the Faraday effect is avoided by using high-frequency alternating current with a frequency of more than300 kHz. This current only generates heat. This heat can

be used for three types of application:- thermal coagulation of tissue- cutting of tissue- vaporisationIn thermal coagulation, the electrical current heats thetissue only slowly. The water inside the tissue evaporatesslowly and cellular proteins are denaturated, thus resultingin coagulation of the tissue.For cutting tissue, the electrical current heats the tissue

very quickly. The temperature of the tissue inside the cellsincreases quickly and the intracellular water evaporates,destroying cell membranes.For vaporisation, the electrical current is set to high values.The intracellular water evaporates immediately, resulting inshrinked tissue and a large coagulation zone for TURis orTCRis.



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Bipolar HF Surgery.In bipolar HF surgery, the electrosurgical current passesbetween the two electrodes of the instruments (e.g., the

jaws of a bipolar forceps). On the small surface betweenboth electrodes, a high current density accumulates, whichcreates enough heat to coagulate and/or cut tissue.As a result, bipolar HF surgery only requires electrosurgicalcurrent to be conducted over a very short distance throughthe patient’s body.

Monopolar HF Surgery.

In monopolar HF surgery, the electrosurgical currentpasses from the point-shaped “active” electrode (A in thediagram) to the larger “patient plate” (P). On the smallsurface of the active electrode, a high current densityaccumulates, which creates enough heat to coagulate, cutand/or vaporize tissue.Active electrodes as described in this System Guide are:- all HF electrodes- HF-resection electrodes (in resectoscopes)

- monopolar hand instruments (e.g., monopolar forcepsand scissors)

Other terms used for a patient plate are:- neutral electrode- indifferent electrode- p-plate



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Connecting the Patient Plate (Only for Monopolar HF Surgery).• Placethepatientplateclosetotheoperationaleld,if

possible on the upper arm or on the thigh.• Makesurethattheskinisfreefromhairandgrease.• Whenusingareusablepatientplate,applyconductivegel

evenly on the patient plate.Refer to the patient plate’s instruction manual.Most single-use patient plates do not require conductivegel.

• Makesurethatcontacthasbeenestablishedovertheelectrode’s entire surface.

• Placethelongedgeofthepatientplatetowardstheactive electrode.

Correct application of a neutral electrodewith even current distribution on the twoelectrode surfaces.

Incorrect application of a neutral electrode.This will result in uneven current distribution

on the two electrode parts.An alarm is issued and the surgicalinstrument will not be able to be activated.



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Current Flow in the Body (Only for Monopolar HF Surgery).The current paths inside the patient’s body should be short

and must proceed diagonally. Current paths must never runtransversely through the body or across the thorax.

Illustration:Acceptable locations of the patient plate (black) andallowable range of application of the active electrodes(grey).Make sure that the current path is as short as possible!

Patient Position.• Thepatientmustbeinsulatedagainstallelectrically

conductive parts. Make sure that the patient does notcome into contact with other metal parts (e.g., operatingtable) in any case.

• Groundtheoperatingtable.• Placethepatientonadry,electricallyinsulatingsurface.• Preventanycontactbetweendifferentskinsurfaces

(arms, legs). Place dry gauze between the body andarms and legs to prevent such contact.



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HF Cables.Always use Olympus HF cables.Visually inspect the HF cable and its surface. Make sure

that it does not have any cracks, scratches, edges, dents,or bends. Make sure that no wires protrude from the inside.Make sure that all parts are securely in place.Replace defective HF cables.In order to plug or unplug an HF cable, always pull at theplug. Never pull at the cable.Do not place HF cables directly on the patient’s skin.Do not lay HF cables in loops.UseonlyplasticclipsorhookandloopfastenerstoxHF

cables to surgical drapes. Do not use metal clips or forceps.

Active Instruments.Do not use worn-out or defective active electrodes, forceps,or scissors.Dispose of these instruments when they are no longer inperfect working condition.Do not attempt to repair active electrodes, forceps, orscissors.

Do not attempt to bend electrodes in shape.

HF Unit Instruction Manual.Refer to the HF unit’s instruction manual.

Maximum Power Output.The maximum power output for the instruments islimited. Use the lowest possible output setting necessary.Alwaysrefertotheproduct-specicinstructionmanualforinformation on the output settings.

WARNING! Spray Coagulation.Some HF units have a so-called “spray coagulation”feature.The application of “spray coagulation” destroys theelectrodes. There is a risk of spark-over to the patient,



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users or a third party.Do not apply the “spray coagulation” feature of the HF unitduring endoscopic interventions.

Spray coagulation should only be used if the compatibilityoftheinstrumentstobeusediscertiedintheirproduct-specicinstructionmanuals.

Safety Precautions for Monopolar Procedures.- Switch off the HF unit when not using it.- Tocoagulatetissue,rstpositiontheelectrodeonthe

target area and then activate the HF current.- Do not activate the HF current if the electrode is not in

contact with tissue.- Make sure that the electrode is at least 10 mm away from

all other endoscopic equipment.

- Tissue areas that are in contact with the active electrodemust not touch other tissue areas. Coagulate cord-liketissue parts on their narrowest point. Otherwise, sidecoagulation or perforation may result.

Safety Precautions for Bipolar Interventions.- Switch off the HF unit when not using it.- First position the bipolar instrument on the target area

and then activate the HF current.- Do not activate HF current without tissue between

both electrodes of the bipolar instrument. The bipolarinstrument might be destroyed.

- Some HF units feature a so-called AUTO START mode.In the case of accidental tissue contact, the AUTO STARTmode involves the risk of unintentional coagulation.Therefore electrodes and forceps used in endoscopy

PPPP



39


must not be operated in the AUTO START mode. Do notselect the AUTO START mode.

Non-Flammable Gases.Whenperformingelectrosurgery,useonlynon-ammablegases (e.g., CO2)forinsufation.

Irrigation Fluids.When performing monopolar electrosurgery, use only non-conductiveuids.ForTURis/TCRis,useonlyconductiveuids.

Suction/Irrigation.When using active electrodes with a suction channel, donot simultaneously activate the HF current and the suction/ irrigation function.

Conductive Lubricant.When inserting instruments into the urethra duringelectrosurgical procedures, use conductive lubricants only.

WARNING! Risk of Injury.Do not use conductive lubricants to lubricate workingelements. There is a risk of spark-over to the patient, usersor a third party.

Malfunction.If the unit is set to a level which previously workedsufcientlybutnowdoesnotsatisfactorilycoagulatethetissue, do not increase the output setting. Instead, makesure that:- the patient plate is seated correctly.- all HF cables and plugs are securely attached and free of

corrosion.- the HF-resection electrode is securely attached.- the insulation of the HF cables, the HF electrode, and the

instrument are not damaged.



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- the electrode’s distal end is clean and free of corrosion.- the instrument has been assembled properly and all parts

are securely attached.

- for monopolar HF interventions: a non-conductiveirrigationuidisused.- forTURis/TCRisinterventions:aconductiveirrigationuid

(0.9 % NaCl) is used.- a conductive lubricant is used with instruments inserted

into the urethra.

Potential Risks.The application of HF current involves the risk of burns.

According to their causes, burns can be divided into:- endogenous burns- exogenous burns

Endogenous Burns.Endogenous burns are burns which are caused by a highcurrent density in the patient’s tissue.Possible reasons are:- the available conductive surface of the patient plate is

too small in relation to the power output used (select asuitably sized patient plate!)

- the actual conductive surface of the patient plate is toosmall (make sure that the entire surface of the patientplate is in contact with the patient’s skin),

- the patient is inadvertently positioned in contact withelectrically conductive parts (make sure that the patienthas been insulated against all electrically conductiveparts),

- direct contact between skin areas and HF cables maylead to electrical capacitance which could cause burns.

Exogenous Burns.Exogenous burns are burns which are caused by the heatofigniteduidsorgases.Theymayalsobecausedbyexplosions.Possible reasons are:



41


- ignition of skin cleaning agents and disinfectants,- ignition of narcotic gases,- ignitionofinsufatedgases(useonlynon-ammable

gasesforinsufation!),- ignition of endogenous gases (bowel),- explosion of oxy-hydrogen gas inside the urinary

bladder, ureter, kidney, or the uterine cavity (evacuateaccumulated gas!).

Interferences.The application of HF current interferes with other medicalequipment. Interferences with ECG, cardiac pacemakers,

laser applications, and video imaging are widely known.For other possible interferences, refer to the HF unit’sinstruction manual.

ECG.If an electrocardiograph is used, the neutral ECG cablemust be attached to the patient plate of the HF unit. Placethe active electrode at a minimum distance of 150 mm fromthe ECG electrodes. Do not use ECG needle electrodes

for monitoring. All ECG electrodes must be equipped withprotective impedances or HF choke coils.

Cardiac Pacemakers.Pacemakers may be damaged by electrosurgical current.Consult a cardiologist before the procedure. Never useelectrosurgical current on outpatients with pacemakers.

Video Imaging.HF current may interfere with video images. To preventsuch interference, HF equipment and video imagingequipment should be connected to different power supplycircuits.



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3.4 Laser Surgery

Theterm“laser”standsfor“LightAmplicationby

Stimulated Emission of Radiation”. A laser is a device forproducing monochromatic, coherent, luminous beams.When a beam comes in contact with living tissue, itsenergy is converted into thermal energy, creating a cutting,vaporization or coagulation effect (depending on the lasertype used).

Instruction Manual.Refer to the laser unit’s instruction manual.

Switch Off Laser.If the laser is not being used or if surgical instruments arebeing changed, switch off the laser or switch it to standbymode.

Power Output.Always select the lowest possible laser output for theprocedure.

Potential Risks.The application of laser involves certain risks like:- Eye damage- Skin damage- Chemical risks- Mechanical risks- Electrical risks

Eye Damage.Eye damage includes:- in the range of wave lengths between 200–400 nm (UV):

photophobia and/or damage to structures at the front eye(inammation,watering),

- in the range of wave lengths between 400–1400 nm(visible light and near infrared): damage to the retina andthe eye’s vitreous body,



43


- in the range of wave lengths between 1.4–1000 µm(infrared): damage to the cornea and structures at thefront of the eye.

Skin Damage.The most frequent skin damage is burns, which can beas serious as fourth-degree burns. Additionally, lasersin the range of wave lengths between 250–320 nm arecarcinogenic.

Chemical Risks.Inammableorexplosivesubstancesmaybeignitedbya

laser beam.

Mechanical Risks.

Particles can be emitted from the target and other surfacesfollowing contact with the laser.

Electrical Risks.Electrical risks are caused by the high voltage applied tothe laser.

Safety Precautions.- Protective glasses:When using a laser, always wear protective glasses that aredesignedtolteroutthelaser’swavelength(s).- Patient’s eyes:Cover the patient’s eyes or use protective glasses that aredesignedtolteroutthelaser’swavelength(s).- Non-reectiveequipment:Donotusereectingequipmentwithinthelaserrange.Allendoscopic instruments used in conjunction with the laser



44


must be black or matted at the distal end.

WARNING!

Interferences with Insufators.Uncontrolledinowofgaseousinsufationmediamaycauselethalembolisms.Besidestheinsufator,othersystems can act as gas supply sources. These mayinclude: lasers with probe tips cooled using CO2 or othergases, and Argon-Enhanced Coagulation Systems (AEC).When using such systems in laparoscopic procedures,makesuretouseaninsufatorwithanactivesuctioncontrol system.

Iftheinsufatoremitsawarningforintra-abdominalover-pressurization, quickly open the stopcock or valve of theinsufationinstrumentinsertedintothepatient.

WARNING! Inammable and/or Explosive Gases.Lasersurgical procedures may only be performed if non-ammablegases(CO2)areusedforinsufation.Do not perform lasersurgical procedures in areas where

ammableorexplosivegasesarepresent. In addition to anaesthetic agents, gases formed insidethe patient’s intestinal and urological tract represent anexplosion hazard.



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4 Indications and Contraindications

4.1 Arthroscopy

WARNING! Closely Monitor Irrigation Fluids and Volumes Since most arthroscopic procedures utilize irrigationuids,itisimportantthatthecorrectuidbechosenandthatinowandoutowvolumesbestrictlyobserved.

Appropriate measures should be taken to prevent thepossibilityofuidoverload.

Indications Include the Following Joints: - Ankle- Knee- Shoulder- Wrist

4.2 ENT (Ear, Nose, Throat)

Indications.A comprehensive nasal exam and/or computerizedtomography (CT) scan prior to sinus surgery may identifyclinical conditions that alter patient management.Indications include diagnosis and treatment in:- Nasal endoscopy- Sinoscopy



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4.3 Hysteroscopy

DANGER!

Control Gas Inow Uncontrolledinowofthegaseousdilationmediummaycause lethal embolisms. Never use lasers with laser probetips that are cooled with CO2 or other gases; there is adangerofanuncontrolledinowofgasandlife-threateningembolism.

WARNING! - If pregnancy is suspected, a pregnancy test should be

given prior to the diagnostic hysteroscopy procedure.-Duringcontinuous-owhysteroscopy,strictuid

intake and output surveillance should be maintained.Intrauterine instillation exceeding 2 liters should beundertakenwithgreatcareduetothepossibilityofuidoverload.

- When performing hysteroscopic electrosurgery, thedistention medium must be electrically nonconductive.

NOTE - Vaginal ultrasonography prior to hysteroscopy may

identify clinical conditions that could alter patientmanagement.

Diagnostic and Operative Indications Include: - Abnormal uterine bleeding- Amenorrhea- Directed biopsy- Endometrial ablation- Evaluation of an abnormal hysterosalpingogram- Infertility and pregnancy wastage- Intrauterine foreign body- Pelvic pain-Removalofsubmucosalbroidsandlargepolyps- Submucous myomectomy- Transection of intrauterine adhesions



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- Transection of intrauterine septa

Absolute Contraindications Include:

-Acutepelvicinammatorydisease(PID)Relative Contraindications Include: - Cervical/vaginal infection- Inability to distend the uterus- Invasive carcinoma of the cervix- Known pregnancy- Medical contraindication of or intolerance to anesthesia- Recent uterine perforation

- Uterine bleeding or menses

Relative Contraindications to Endometrial Ablation Include: - Adenomatous endometrial hyperplasia- Pelvic pain (subtle PID)- Severe adenomyosis- Surgical skill (“Acute Technical”).Hysteroscopic endometrial ablation, whether laser

or electrosurgical, should not be performed withoutadequate training and clinical experience. Additionally,tissue sampling is required prior to destruction of theendometrium. The following are clinical conditions that cansignicantlycomplicatehysteroscopicendometrialablation:- Uterine anomalies- Uterine leiomyoma

Relative Contraindications to Hysteroscopic Myomectomy Include: - Inability to circumnavigate the myoma (re: myoma size) -

predominantly intramural myomas with small submucouscomponents.

- Severe anemia- Surgical skill (see above)

Complications May Include:



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- Cerebral edema- Hyponatremia- Hypothermia

- Idiosyncratic reaction- Pulmonary edema- Rupture of a fallopian tube secondary to tubal

obstruction.- Uterine perforation resulting in possible injury to the

bowel, bladder, major blood vessels and ureter.

4.4 Laparoscopy/Thoracoscopy WARNING! - Ultrasonography prior to laparoscopy may identify clinical

conditions that could alter patient management.- Abdominal puncture sites 10 mm or greater (for the

introduction of auxiliary instrumentation) may be a sourceof herniation.

- Care must be taken during the procedure (e. g.,

insertion of the Veress needle, placement of trocars),as the following complications may occur: gasembolism, vascular injury, perforation of hollow viscus,subcutaneous emphysema, extraperitoneal emphysemaand/or tension pneumoperitoneum.

- Hypothermia. Check the patient’s body temperatureregularly throughout the procedure. Carbon dioxide (CO2)gas,owingcontinuously,absorbsheatandcancausehypothermia.

-Insufation.Electrosurgicalproceduresmayonlybecarriedoutsafelyifnonammablegases(suchasCO2)areusedforinsufation.



49


DirectaccessofinsufatedCO2 gas to the vascular system(e.g., through an open vessel in the intra-abdominal orintra-thoracic cavity, or an improperly inserted Veress

needle) may result in gas embolism.Thethoracoscopicinsufationpressureshouldnotexceed 10 mm Hg.

General Surgery Indications Include: - Abdominal trauma- Appendectomy- Colon resection- Diagnosis and treatment of abdominal pain.

- Gall bladder and biliary tree disease- Gastric diseases- Hernia repair- Laparoscopic cholecystectomy- Liver biopsy- Liver disease- Nissen fundoplication- Pelvic infection- Pelvic lymph node dissection

- Pelvic mass- Pelvic pain- Perihepatic adhesions- Removal of intraperitoneal foreign body- Varix ligation

OB/GYN Indications Include: - Determination of the presence and extent of pelvicinammatorydisease(ifnotinanacutestage)

- Determination of the presence, extent and therapy ofpelvic endometriosis

- Diagnosis and/or treatment of ectopic pregnancy- Evaluation, diagnosis and/or treatment of small pelvic

tumors, including myomata- Evaluation of congenital anomalies- Evaluation of ovarian endocrinopathy- Infertility workup



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- Laparoscopy assisted vaginal hysterectomy (LAVH)- Ovarian biopsy- Ovarian cyst

- Retrieval of foreign bodies- Unexplained pelvic pain (acute, chronic)- Unexplained primary or secondary amenorrhea- Urinary incontinence- Uterine suspension- Visualization, diagnosis and/or treatment of perforated

abdominal (pelvic) organs

Laparoscopy Absolute Contraindications Include:

- Bowel obstruction- Class IV cardiac decompensation- Diaphragmatic hernia- Ileus- Infection with acute peritonitis- Intraperitoneal hemorrhage

Laparoscopy Relative Contraindications Include: - Bleeding diathesis

- Cardiac disease- Cardiovascular instability- Chronic obstructive lung disease- Hypovolemic shock- Hypoxemia- Infection with acute peritonitis- Invasive carcinoma of the cervix- Liver failure with established collateral vessels- Medical contraindication or intolerance to anesthesia- Obesity- Pregnancy longer than 16 weeks gestation or abdominal

mass of comparable size- Previous abdominal surgery- Septic peritonitis- Thin nulliparous patient



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Laparoscopy Complications May Include: - Abdominal adhesions- Ascites, hyponatremia, axotemia

- Delayed hemorrhage- Fever, peritonitis- Gas embolism- Incisional hernia- Infection- Pain- Perforation of solid organs- Perforation of the hollow viscus- Peripheral nerve damage

- Vascular injury

Thoracoscopy Indications Include: - Blebs and bullous lung disease- Cysts of the thorax- Esophageal disease- Lung disease- Mediastinal and hilar masses- Pericardial disease

- Pleural disease- Spinal disease- Sympathectomy- Trauma

Thoracoscopy Absolute Contraindications Include: - Bleeding diathesis- Cardiovascular instability- Chronic obstructive lung disease- Hypovolemic shock- Hypoxemia- Infection (excluding empyema)-Insufcientspaceinpleuralcavity- Medical contraindication or intolerance to single-lung

anesthetic



52


Thoracoscopy Relative Contraindications Include: - Multiple previous thoracotomies- Multiple previous pleurodesis

- Presence of pleural adhesions

Thoracoscopy Complications May Include: - Arrhythmia- Atelectasis-Bronchopleuralstula- CO2 embolism tension pneumothorax- Extrapleural trocar placement- Hypercarbia

- Hypotension- Hypoxemia- Infection- Lung injury- Mediastinal Compression- Pain- Parenchymal hemorrhage and air leak- Pneumothorax- Trocar damage to intercostal bundle

- Ventilator dependence (>48 hrs.)

4.5 Urology

WARNING! - Since most urological endoscopy procedures utilizeirrigationuids,itisimportantthatthecorrectuidbechosenandthatthevolumesofinowandoutowbestrictly observed. Appropriate measures should beundertakentopreventthepossibilityofuidoverloadofthe patient.



53


Indications Include: - Cystoscopy- Resection

- Ureterorenoscopy- Urethroscopy



54




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5 Reprocessing

NOTE! Some reprocessing methods may lead to increased wearof the products. Inspect the products thoroughly before usefor traces of wear.

Information in this Document.The following reprocessing information supplements thedetailedreprocessinginformationintheproduct-specicinstruction manual. However, if the information given in this

chapterdiffersfromthatintheproduct-specicinstructionmanual,usetheinformationgivenintheproduct-specicinstruction manual.

5.1 General Policy

The Reprocessing Cycle.

Olympus endoscopic instrumentation (if not labelled as asingle-use product) is to be reprocessed by the methodsdescribedintheproduct-specicinstructionmanualandinthis chapter.To minimize the risk of infecting patients, users or thirdparties, reprocess the endoscopic instrumentation beforeeach use.

Standards.Refer to the following standards:- ISO 17664 “Sterilization of medical devices”- ANSI/AAMI TIR12 “Designing, Testing, and Labeling of

Reusable Medical Devices for Reprocessing in HealthCare Facilities”

- ANSI/AAMI ST79 “Comprehensive guide to steamsterilization and sterility assurance in health carefacilities”



56


Additional standards and regulations may be applicable.Contact your local hygiene representative for localstandards and regulations.

Disinfection vs. Sterilization.The decision on the reprocessing method must be made inaccordance with international and national standards andguidelines. For thermostable equipment, sterilization shouldbe preferred to disinfection.

Manual Cleaning vs. Automatic Cleaning.In general, instruments can be cleaned manually or

automaticallywithsufcientresults.Manualcleaningmethods involve infection control risks for the personnelresponsible for reprocessing. Automatic methods reducethese risks and provide the advantage of standardized,reproducible and validated processes. Therefore, ingeneral, Olympus recommends to prefer automaticcleaning procedures.Contact your local hygiene representative to determine thesituation in which manual cleaning rather than automatic

cleaning would be appropriate in your facility.

Deionized/Distilled Water vs. Potable Tap Water Olympus recommends the use of deionized/distilled waterforthenalrinseaftercleaning.Inaddition,potabletapwaterisacceptablefornaldevicerinsingaftercleaning(refer to the note below).

NOTE! Risk of Corrosion and Residue When Using Potable Tap Water Use of chlorinated potable water for device reprocessingand/or rinsing may lead to corrosion of the device. Inaddition, use of potable tap water may result in residue(e.g., mineral residues, such as calcium) on the devicefollowing reprocessing and/or rinsing. Visually inspectthe device prior to each use. If there are visible signs of



57


corrosion or residue remaining, send the device to Olympusfor inspection and repair. Refer to AAMI TIR34: “Waterfor the reprocessing of medical devices” for guidance

on selection of appropriate water quality for devicereprocessing.

After Use.After use, immediately treat the instruments as describedintheproduct-specicinstructionmanualandinsection“Preparation for Reprocessing at the Point of Use” in thismanual.

Brand-New Instruments.Always treat brand-new instruments as if they have beenused. Brand-new instruments must be reprocessed using acomplete reprocessing cycle.



58


5.2 Reprocessing Processes and Agents

The materials and construction of the Olympus endoscopic

instrumentation may not be compatible with certainreprocessing methods.Olympusprovidesinformationontheefcacyand/ormaterial compatibility of device reprocessing methodsaccording to the following: - validatedforefcacy - veriedformaterialcompatibility

Validated for Efcacy.

Validatedforefcacymeansthattheefcacyoftheprocessor agent has been validated for reprocessing an instrumentasdescribedintheproduct-specicinstructionmanualandin this manual.

Veried for Material Compatibility.Veriedformaterialcompatibilitymeansthat–accordingto current knowledge – the reprocessing process oragent does not negatively affect materials or functional

performanceoftheinstrument.Veriedformaterialcompatibilitydoesnotmeanthatefcacycanbeguaranteed.

Chosing a Reprocessing Method.The actual reprocessing method chosen by your institutionshould be determined by national and local guidelines aswell as your hospital’s infection control committee.

Chosing a Reprocessing Agent.The actual cleaning or disinfectant chosen by yourinstitution should be determined by national and localguidelines as well as your hospital’s infection controlcommittee.



59


Monitoring.Regularly monitor and validate all disinfection andsterilization processes.

Although there are no biological indicators available toverify the disinfection processes, there are test stripswhich will permit monitoring the concentration of thedisinfectant agent. Monitor the concentration according tothe instructions provided by the disinfectant manufacturerto ensure that the solution has not been diluted below itseffective concentration.To monitor sterilization processes, use an appropriateindicator.

Material Compatibility Chart.The material compatibility chart in the Appendix of thisdocument lists those cleaning, disinfection, and sterilizationprocesses and agents that have been thoroughly tested oncomponents of rigid endoscopes and their accessories.

CAUTION! Risk of Damage.

Not every instrument is compatible with all processesmentioned in this manual. Before reprocessing aninstrument,readtheproduct-specicinstructionmanual.For more details, contact an Olympus representative.



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5.3 Health and Safety at Work

WARNING!

Protection Against Infection or Skin Irritation.Patient debris and reprocessing chemicals are hazardous.Wear personal protective equipment to guard againstdangerous chemicals and potentially infectious material.During cleaning and disinfection or sterilization, wearappropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing and chemical-resistantglovesthattproperlyandarelongenoughso that no part of the skin is exposed. Always remove

contaminated protective equipment before leaving thereprocessing area.

WARNING!

Toxic Chemical Fumes.The disinfection/sterilization room must be adequatelyventilated. Adequate ventilation helps protect against toxicchemical fumes.

WARNING! Inammable Liquids.Store alcohol (ethanol, isopropanol) in an air-tight container.Alcoholstoredinanopencontainerisarehazardandwillloseitsefcacyduetoevaporation.



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5.4 Decontaminating the Surface of Electrical

Units

This section describes how to decontaminate the surfacesof electrical units. Units are not sterilizable. The surface ofelectrical units should be cleaned and disinfected.

Cleaning Units.• Turnoffthepowerswitch.• Disconnectthepowercable.• Lettheunitcooldowntoroomtemperature.

• Removealldustanddebriswithanappropriate,lint-freecloth which, if necessary, has been moistened.



62


Disinfecting the Unit’s Surface.• Todisinfecttheunit,wipeitwithacloththathasbeen

moistened with a disinfectant.

Refer to national or local guidelines regarding theapproval of using alcohol as a disinfectant. Select thedisinfectant according to its indications for use. Thedisinfectant must be approved by the manufacturer forthe (surface) disinfection of medical devices and for thematerial to be disinfected. Make sure not to exceed themanufacturer’sspecicationontemperature,contacttimeand concentration.Make sure that the unit has been completely cooled

down to room temperature to avoid any risk of ignition orexplosion.Never immerse units in liquid!

5.5 Preparation for Reprocessing at the Point of Use

Prepare reusable instruments for later reprocessing directlyin the operating room immediately after use as described inthis section.In order to avoid incrustations formed by residual blood orproteins, all equipment must be reprocessed immediatelyafter use. If this is not the case, special measures must betaken to preclean the equipment.

Single-Use Products.• Separatesingle-useproductsfromreusableproducts.• Disposeofsingle-useproducts.• Disposeofwasteaccordingtolegalrequirements.• Ifnecessary,sterilizewastebeforedisposal.



63


Reusable Products.• Removeheavydebrisfrominstrumentsbywipingwithan

appropriate, single-use lint-free cloth or sponge.

• Disassembletheinstrumentsasdescribedintheproduct-specicinstructionmanual.Donotuseexcessiveforce;this will damage the instruments.

• CleantheactivepartsofHFelectrodesandjawsofmonopolar and bipolar forceps using 3 % hydrogenperoxide.

• Removethesealingcaps.• Openallstopcocks.

• Handinstrumentsthatcannotbedisassembled: Flush the lumen of the hand instrument with water untilclearwaterowsfromthehandinstrument’sdistalend.

Aq. dest.



64


• Separatetelescopesfromotherinstruments.

• Ifdesired,instrumentscanbeimmersedincleaningordisinfectant solution immediately after use.

Transport of Reusable Products.• Transportreusableproductsfromthepointofusetothe

reprocessing area.In general, the instrument can be transported wet ordryorimmersedinliquids.Refertotheproduct-specicinstruction manual for exceptions.• Containreusableproductsduringtransporttoavoid

possible environmental or personnel contamination.

• Ifinstrumentsaretransportedinadrycondition,makesure that gross debris does not dry. Start the followingcleaning process immediately after use.

• Ifinstrumentsarecontainedimmersedinliquids,startthefollowing cleaning process within 1 hr. after use. Do notuse physiological saline solution for immersion.

CAUTION! Risk of Instrument Damage.Reprocess the instruments immediately after use. Do notexceed the time limits for transport indicated above. Do notleave used instruments overnight before reprocessing.If instruments are left in dry condition for a longer period,heavy debris may dry to the instrument, leading toincrustationsthatmaybedifculttoremove.If instruments are left immersed in liquids for a longerperiod, the instrument may be damaged and the



65


instrument’s sealings may be damaged or fail.When using cleaning or disinfectants, make sure not toexceedthemanufacturer’sspecicationontemperature,

immersion time and concentration.

5.6 Manual Cleaning

This section describes how to perform manual cleaningof endoscopes and their accessories in general. Askyour local Olympus representative for the availability of

reprocessing cards.

Manual Cleaning Procedure.• Immediatelyafteruse,disassembletheinstrumentsasdescribedintheproduct-specicinstructionmanual.

• Openallstopcocks.



66


• Thoroughlyrinseallinstrumentcomponentswithwater (< 20 °C).

• Removepersistentdebriswithanon-acidiccleaningagentthathasbeenveriedandapprovedbyitsmanufacturer for cleaning medical endoscopes. Makesure to observe the instructions of the cleaning agent’smanufacturer.

• Donotimmerseinstrumentationformorethan60min.

Depending on the cleaning agent, the instrumentationmay only be immersed for a shorter period. Refer to theinstructions of the cleaning agent’s manufacturer forimmersion time.

• Tocleaninternalparts,usecleaningpistol,appropriatecleaning brushes, and cleaning wire. The availableOlympus products are described below.

• Performthisprocedureuntilallvisualdebrishasbeencompletely removed.

• Aftercleaningtheinstrument,rinseitwithdeionizedwater. Do not immerse instrumentation for more than 60min.



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• Letallpartsoftheinstrumentdraincompletely.

• Useanappropriate,soft,single-use,lint-freeclothorsponge to wipe off remaining water.

• Completelydrytheinstrument.

Cleaning Pistol O0190.

• Selectanappropriateattachment:1) For syringes and cannulas with “Record”-connector2) For pipettes3) For catheters, stopcocks, valves, and endoscopes4) For syringes and cannulas with Luer-lock connector5) For drainage tubes6) For glass jars7) Spray nozzle8) Water jet blast for suction

1) 2) 3) 4) 5) 6) 7) 8)

• Immersetheinstrumenttobecleanedinwater.• Firmlypresstheattachmentontothenozzleportofthe

cleaning pistol.



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• Openthewatertap.Ifberscopesarecleaned,donotexceed a maximum pressure of 0.5 bar.

• Firmlypressthecleaningpistolwiththeattachment

against the instrument to be cleaned (while submersedin water).• Activatethehandleseveraltimesuntilalldebrisis

removed. Adjust the pressure of the water jet by meansof the knurled nut (see arrow).

• Closethewatertapafteruse.

Cleaning Brushes and Cleaning Wire.• Selectanappropriatecleaningbrush/wire:

Cat.No. .. Dimensions ......UseA0440.... 0.6 x 500 mm ...channels in uretero-renoscopes,

channels for guidance ofcatheters

A0441.... 2.5 x 360 mm ...sheaths (5–7.5 Fr.), working

inserts, bridges, channels forguidance of resection electrodes

A0443.... 6 x 360 mm ......4–5 mm trocar tubes, sheaths(15–17 Fr.), arthroscope trocartubes, telescope channels ofurologic and gynaecologicinstruments

A0444.... 4 x 500 mm ...... shafts of HiQ hand instrumentswith a length of 450 mm

A0445.... 9 x 360 mm ......sheaths (19.5–27 Fr.)A0446.... 4 x 360 mm ......sheaths (8–12 Fr.), shafts of HiQ

hand instruments with lengths of250 and 330 mm

A0447.... 12 x 360 mm ....sheaths (28.5–30 Fr.), 8–11 mmtrocar tubes

A0448.... 4 x 60 mm ........stopcocks



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A0449.... 16 x 360 mm ....13–15 mm trocar tubes,rectoscopes,anoscopes, proctoscopes

A0450.... 20 x 360 mm ....20 mm trocar tubes, rectoscopes,anoscopes, proctoscopes,amnioscope sheaths

A0451.... – ....................... for all surfacesA0452.... 1.0 x 700 mm ...channels in uretero-renoscopes

• Immersetheinstrumentandthecleaningbrush/wireintothe liquid in order to avoid splashing.

• Introducethecleaningbrush/wireintotheinstrument’s

distal opening and advance the cleaning brush/wire untilit reaches the proximal opening.

• Movethecleaningbrush/wirebackandforthuntilthebrush/wire is free of visible debris.

• Removethecleaningbrush/wirewhiletheinstrumentandthe cleaning brush/wire are immersed in the liquid.

• Checkthechannel’slumenforfreepassage.Ifthisisnotthe case, repeat the procedure.

• Cleananddecontaminatethebrush/wireaftereachuse.The cleaning brushes listed above are autoclavable.

Cleaning Optical Surfaces.Optical surfaces are:- a telescope’s objective cover glass- a telescope’s eyepiece cover glass- a telescope’s light-guide connector- a camera head’s lens window- the video adapter’s lens windows- the light admission surface on the light-guide plug that is

attached to the light source- the light emission surface on the light-guide plug that is

attached to the instrument• Removealladaptersfromthetelescope’slight-guide

connector.• Removealladaptersfromlight-guidecables.• Removethetelescope’seyepiececup(ifapplicable).



70


• Cleantheopticalsurfaceswithacottonswabthathasbeen moistened with 70 % alcohol (ethanol). Never wipewith a metal cotton applicator.

Do not use other instruments for cleaning opticalsurfaces.

WARNING! Infection Control Risk with Cleaning Agents.Use only those cleaning agents which have been approvedby their manufacturer for surgical instrument cleaning andwhich feature processes in accordance with national andlocal guidelines. There is an infection control risk when

usinginsufcientcleaningagents.

WARNING! Insufcient Cleaning Efcacy.Thecleaningefcacymaybecompromisedifthedetergentxesproteinstotheinstrument.Forpre-cleaningor cleaning, use only detergents with good cleaningcharacteristics.Avoidanyproteinxationpriortoorduringcleaning caused by the process.

WARNING! Risk of Reduced Cleaning Effectiveness in Instruments with Small Lumen.If instruments with small lumen are cleaned, there is arisk that the inner lumen is not soaked with water and/orcleaning agent. Always rinse instruments with small innerlumen by connecting them to an irrigation tubing, a rinsingsyringe or the cleaning pistol.



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CAUTION! Risk of Damage due to Incompatible Cleaning Agents.Incompatible cleaning agents may considerably damage

Olympus endoscopes and accessories. Use only solutionsthatarecertiedbytheirmanufacturersassafeforendoscopic instrument cleaning.

CAUTION!

Risk of Damage due to Cleaning Agents Residues.Cleaning solutions may contain various aggressivecompounds which could lead to corrosion of the instrument.To effectively remove residues, rinse the instrumentthoroughly with deionized water. Do not use tap water forrinsing because it might be chlorinated.

CAUTION! Risk of Damaging Telescopes.

Always clean each telescope separately. Do not cleanwith other telescopes or other instruments. Make sure thattelescopes do not touch each other.



72


WARNING! Infection Control Risk with Cleaning Pistol.Water splashing from the cleaning pistol may contain

infectious agents. Always use a face shield to protect yourmouth and eyes. Adjust the water pressure to a minimumlevel to satisfactorily clean the instruments. Alwaysimmerse the instrument to be cleaned and the cleaningpistol in water before starting the process to preventsplashing.

5.7 Ultrasonic Cleaning

Ultrasonic Cleaning Procedure.Use only ultrasonic cleaners indicated by theirmanufacturers for cleaning endoscopic instruments. Useonlycleaningsolutionsspeciedbytheirmanufacturersfor the use in ultrasonic cleaners. Refer to the instructionmanual of the ultrasonic cleaner and the disinfectant.

• Switchoffthebath’sheatingsystem.Onlycleancomponents at room temperature.

• Dependingonthedegreeofcontamination,immersethe instrument in an ultrasonic cleaner for 5 min. and amaximum of 15 min. at a frequency of 38–47 kHz.Makesurenottoexceedthemanufacturer’sspecicationon immersion and concentration.

• UsegraspingforcepsforinstrumentsO0185withpadded jaws to remove instruments from the ultrasonic cleaner.• Rinsetheinstruments.• Letallpartsdrain.• Useanappropriate,lint-freeclothorspongetowipeoffremaininguid.

• Completelydrytheinstrument.



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WARNING! Infection Control Risk with Ultrasonic Cleaning.Vapors from ultrasonic cleaning units may contain

infectious agents as aerosols. Always enclose theultrasonic cleaner as per the manufacturer‘s instructionsduring operation. Always use a face shield and haveadequate ventilation in place during ultrasonic cleaning.

WARNING! Insufcient Cleaning Efcacy.

Thecleaningefcacymaybecompromisedifthecleaningagentxesproteinstotheinstrument.Forpre-cleaningorcleaning, use only agents validated to provide effectivecleaning.Avoidanyproteinxationpriortoorduringcleaning by the procedure.

5.8 Manual Disinfection

Prior Cleaning.Endoscopic instrumentation must be meticulously cleanedprior to disinfection. Thorough cleaning removes bothmicroorganisms and organic material. Failure to removeorganic material decreases the effectiveness of thedisinfection process.



74


High-Level Disinfection.In the U.S., agents used to achieve high-level disinfectionaredenedasliquidchemicalgermicidesregistered

with the Environmental Protection Agency as “sterilants/ disinfectants” which are used according to time,temperature and dilution recommended by the disinfectantmanufacturer for achieving high-level disinfection. Theseconditions usually coincide with those recommendedby the disinfectant manufacturer for killing 100 % ofMycobacterium tuberculosis.

Germicidal Effectiveness.

For information on the germicidal effectiveness of anysolution, refer to the solution’s instructions or contact thesolution’s manufacturer.The chemical agent used for disinfection should be capableof killing/deactivating:- Mycobacteria- Vegetative bacteria- Viruses (hepatitis, HIV, BPV etc.)- Fungi

- Some bacterial spores

Disinfection Procedure.• Developadisinfectionprocedureinaccordancewith

instructions provided by the disinfectant manufacturer.• Filladisinfectiontank(e.g.,O0264)withdisinfectant

solution.



75


• Removethedisinfectiontank’ssievetray.

• Disassembletheinstrument.

• Openthestopcocks.

• Placetheinstrument’scomponentsonthesievetray.

• Lowerthesievetrayintothetank.

• Makesurethatallcomponentshavebeencompletelyimmersed. Make sure that no air bubbles stick to theinstrument.Donotexceedtheimmersiontimespeciedby the solution’s manufacturer. In any case, do notexceed an immersion time of 1 hr. Make sure that alllumensarecompletelylledwithdisinfectantsolution.





77


WARNING! Risk of Reduced Disinfection Effectiveness in Instruments with Small Lumen.

If instruments with small lumen are disinfected, thedisinfectant solution must be injected into the small lumenusing a syringe. Otherwise, the disinfectant solutionmay not contact the entire channel surface reducing theeffectiveness of disinfection.

CAUTION! Risk of Damage due to Incompatible Disinfectants.Incompatible disinfectant solutions may considerably

damage Olympus endoscopes and accessories. Use onlysolutionsthatareapprovedandveried(forexamplebyFDA, DGHM or a comparable institution) and that arecertiedbytheirmanufacturersassafeforendoscopicinstrument cleaning and disinfection. For further informationon disinfectant agents, contact Olympus.

Material Compatibility.Olympus instruments have been tested and found to be

compatible with solutions of 1–4 % (w/v) glutaraldehyde(immersion). Information on material compatibilitywhen using peracetic acid can be found in the materialcompatibility chart in the Appendix. Select the immersiontime and the concentration of the solution accordingto the instructions given by the disinfectant solution’smanufacturer. However, the maximum immersion time of 1hr. should not be exceeded.This statement only refers to material compatibility anddoes not indicate any germicidal effectiveness level.



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CAUTION! Risk of Damage due to Exceeded Concentration and Immersion Time.

For information about the concentration and immersiontime, refer to the instructions given by the disinfectantsolution’s manufacturer. Do not exceed the manufacturer’smaximum recommended levels.

CAUTION! Infection Control Risk.

If the instruments are not used immediately afterdisinfection, they must be disinfected prior to next use.

CAUTION! Risk of Instrument Damage.Do not immerse instruments for more than 60 min. in anyliquids.If instruments are left immersed in liquids for a longerperiod, the instrument and its sealings may be damaged.

CAUTION! Risk of Damage due to Disinfectant Residues.Disinfectant solutions or tap water may contain variousaggressive compounds that can corrode the instrument.To remove disinfectant residues, rinse the instrumentthoroughly with (sterile) deionized water.



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5.9 Automatic Cleaning/Disinfection

Automatic cleaning processes are reproducible,

standardizable and feature a validated cleaning process.

Appropriate Washer/Disinfectors.Useonlywasher/disinfectorswhichareintendedspecicallyfor cleaning and disinfection of endoscopic instruments bythe washer/disinfector’s manufacturer. Olympus validatedautomated cleaning/disinfection (thermal) using a washer/ disinfector conforming to the international standard seriesISO 15883. Refer to the washer/disinfector’s instruction

manual.

Selection of Programs.For all thermostable instruments, Olympus recommendsa program that complies with ISO 15883-2. The programused should not exceed a temperature of 93 °C duringthedisinfectionphase.Thetemperatureoftherstinletwater must not exceed 20 °C in order to avoid coagulationof proteins during the pre-rinse phase. During cleaning,

a temperature of 55 °C must not be exceeded in orderto achieve optimum cleaning results. After neutralization,rinsing cycles ensure that no residual cleaning orneutralizing agents remain and affect the next reprocessingstep. Olympus recommends the use of deionized/distilledwaterforthenalrinseaftercleaning.Regardingtheuseofpotable tap water, refer to the note on the use of potable tapwater in the section “General Policy”.• Inordertoavoidtheformationofcondensates,removeall

instrument parts from the machine immediately after theprogram is completed.

• Ifnecessary,drytheinstruments.



80


Do not use programs starting with high temperatures(e.g., 93 °C). This leads to a denaturation of proteins anddebris, thus inhibiting effective cleaning. Make sure that

the program does not include any sudden changes intemperature.

Example for a program cycle:

1. Pre-Rinse2. Cleaning3. Rinsing4. Heating5. Disinfection6. Drying

Automatic Cleaning/Disinfection Procedure.• Makesurethatallinstrumentshavebeensecurelyxedtotheunit’straysorbaskets.Makesurethattheinstruments do not touch each other.

• Fortelescopes,useadequateinstrumenttraystoxthetelescope.



81


• Instrumentswithlumensmustbeattachedtospecialtrays with irrigation devices or directly to the Luer-lockconnectors of the machine. Make sure that all lumens

aresufcientlyirrigated.Checklumensforfreepassagebefore starting the procedure.• Openallstopcocks.• Openthejawsofhandinstruments.• Donotoverloadthewasher/disinfector.• Topreventcorrosion,removetheinstrumentsfrom

the washer/disinfector immediately after the automaticprocedure has stopped.

Cleaning Agents in Automatic Cleaning.Useonlyagentsthatarecertiedbytheirmanufacturersassafe for surgical instrument cleaning.Makesurenottoexceedthespecicationofagent’smanufacturer.Use enzyme-based agents with neutral pH or alkalineagents with a pH value of up to 11 in the working solution.Avoid acidic agents. Even minor residues of non-pH-neutral agents may lead to corrosion of the endoscope’s

material (especially on older chromium-plated instruments).However, if rinsing with neutralizers after cleaning isnecessary, Olympus recommends to remove traces ofneutralizersbyusingdeionized/distilledwaterforthenalrinse. Regarding the use of potable tap water, refer to thenote on the use of potable tap water in the section “GeneralPolicy”.For further information on agents for automatic cleaning/ disinfection processes, please contact Olympus.



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WARNING! Infection Control Risk with Cleaning Agents.Useonlyveriedcleaningagentswhichfeaturevalidated

processes in accordance with national and local guidelines.Thereisaninfectioncontrolriskwhenusinginsufcientcleaning agents.

CAUTION! Reduced Cleaning Effectiveness in Automatic Cleaning due to Coagulation of Proteins.Preferably return the instruments from the point of use tothecleaningareaindryconditiontoavoidproteinxation

caused by cleaning agents or disinfectants. Refer to theproduct-specicinstructionmanual.Makesurethattherstwaterinowintothewasher-disinfector starts with cold temperatures (< 20 °C) to avoidthermal coagulation of proteins.

CAUTION! Risk of Damage due to Elevated Concentration of Cleaning/Disinfectants.

Defects of the washer’s/disinfector’s supply pump cancause an elevated concentration of cleaning agents/ disinfectants, which will damage the instruments. Regularlymaintain the washer/disinfector as recommended by itsmanufacturer.

5.10 Maintenance

Inspection.• Visuallyinspectallparts.Ifnecessary,cleanthemagain.

Instruments should be treated with lubricants in everyreprocessing cycle to maintain their function and toprotect them from corrosion and aging.



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Lubricants.• Differentsterilizationprocessesrequiredifferentkinds

of lubricants. If required, contact the manufacturer of the

sterilization device.Olympus distributes two lubricants:- Grease for stopcock (O0170)- Oil for metal parts and sealings (A0273)

CAUTION! Decrease of Image Quality.Apply all lubricants sparingly. Make sure that thetelescopes’ objective or ocular windows are not smudged

with lubricant.Lubricants on objective or ocular windows considerablydecrease viewability and image quality.

Moving Metal Parts.Lubricate moving metal parts in joints or attachmentdevices.• Applyadropofoiltoallpartstobelubricated.• Useacottonpadtoremoveexcessoil.



84


Stopcocks.Olympus instruments are equipped with two differentstopcocks:

1) Dismantable stopcocks (featuring a knurled nut)2) Maintenance-free stopcocks (not featuring a knurled nut)

Dismantable Stopcocks.Each time after using an instrument with dismantablestopcock, do the following:• Detachtheknurlednutonthecockplug.• Removethecockplug.• Thoroughlycleanallcomponents.• Lightlygreasethecockplugwithstopcockgrease(cat.

no. O0170).• Reinsertthecockplug.

• Fastentheknurlednut.• Reprocess and store assembled dismantable stopcocks

in opened condition.

Maintenance-Free Stopcocks.Do not disassemble maintenance-free stopcocks.Do not grease maintenance-free stopcocks.Reprocess and store maintenance-free stopcocks inopened condition.



85


Silicone Sealings.• ApplyoilA0273tosealingrings.

5.11 Steam Sterilization

If possible, Olympus recommends using fractionatedprevacuum steam sterilization. Steam sterilizationwith prevacuum has been validated for its germicidaleffectiveness with most of the Olympus endoscopes andaccessories.Refertotheproduct-specicinstructionmanual for compatibility with steam sterilization.

Prior Cleaning.Endoscopic instrumentation must be meticulously cleanedprior to sterilization. Thorough cleaning removes bothmicroorganisms and organic material. Failure to removeorganic material decreases effectiveness of the sterilizationprocess. After cleaning, make sure that the instrument iscarefully dried.



86


Steam Sterilization Procedure.• Disassembletheinstrumentation.Refertotheproduct-specicinstructionmanualfor

instruments which can be assembled before steamsterilization. For some products, reprocessing cards areavailable that also provide information on disassembly.


• Placetheinstrumentsinappropriateinstrumenttraysorpouches (for Olympus instrument trays, see the “Storageand Handling” section). Wrap or seal them adequately.Do not seal the instruments in close contact with eachother as this might impair sterilization.

• Refertotheautoclave’sinstructionmanual.

• Useonlyprevacuumautoclavecyclestoensurethatsteamllsalllumens.

• Aftersteamsterilization,lettheinstrumentcooldowngradually to room temperature without additional cooling.Sudden changes in temperature may damage theinstruments.



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Never rinse the instruments with cold water for cooling.Be careful when unloading the autoclave, the contentsmay be hot.

• Makesurethatthesterilepackageoftheinstrumentsisnot damaged. If the package has been perforated, if thesealing has been opened, if the packaging is wet or if thepackaging is damaged in any other way, resterilize theinstruments.

Steam Sterilization Conditions.Olympus recommends to autoclave the instruments asfollows:

Cycle ................Temperature .............. Exposure TimeFractionatedprevacuum .......134 °C ....................... 5 min.

Other autoclaving parameters are:Cycle ................Temperature .............. Exposure TimePre-vacuum ......132 °C (270 °F) ........ 4 minutesPre-vacuum ......135 °C (275 °F) ........ 3 minutes

Autoclavable Olympus products are designed for steamsterilization according to the following standards (in theirrespective latest approved version):- US standard ANSI/AMMI ST46- British standard BS 3970 and HTM-2010- European standard EN 285



88


CAUTION! Risk of Instrument Damage.Do not exceed a temperature of 138 °C. Otherwise,

instrument damage may occur.

Proposed water and steam quality acc. to EN 285..............................................Condensate ..........Feed-waterCoke residues ........................................................≤10mg/lSiO₂........................................≤0.1mg/kg...............≤1mg/lFe ...........................................≤0.1mg/kg............≤0.2mg/lCd ......................................≤0.005mg/kg........≤0.005mg/lPb.........................................≤0.05mg/kg..........≤0.05mg/l

Traces of heavy metals(except Fe, Cd, Pb) ................≤0.1mg/kg............≤0.1mg/lClˉ ..........................................≤0.1mg/kg...............≤2mg/lP₂O₅ .......................................≤0.1mg/kg............≤0.5mg/lConductivity (at 25 °C) ............≤3µS/cm........... ≤5µS/cmpH ...................................................... 5–7 ...................5–7.5Appearance.............................. colourless ............colourless

clear ....................clearwithout residues ..without residues

Water hardness(total alkaline earth ions) .....≤0.02mmol/l......≤0.02mmol/l



89


Example for fractionated prevacuum steam sterilization

1. Evacuation2. Steaming and evacuation 2x3. Heating4. Sterilization5. Evacuation6. Drying7. Aeration



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NOTE! Use of Instrument Trays.- Do not stack the instrument trays or load them on their

side edges during steam sterilization.- For steam sterilization, Olympus recommends a dryingtime of at least 15–30 minutes.Choose an appropriate drying time, depending on thespecicsteamsterilizationunitinyourfacility.

- Users may want to consider the use of appropriate, lint-free absorbing cloth.

5.12 Gas Sterilization

Prior Cleaning.Endoscopic instrumentation must be meticulously cleanedprior to sterilization. Thorough cleaning removes bothmicroorganisms and organic material. Failure to removeorganic material decreases the effectiveness of thesterilization procedure.

The information given in this section describes theinstrument’s material compatibility. It does not describe theefcacyoftheprocedureontheinstruments.

Gas Sterilization Procedure.• Disassembletheinstrumentsaccordingtotheinstructionsprovidedintheproduct-specicinstructionmanualandthe Olympus Endoscopy System Guide (this manual).



91



• Placetheinstrumentsinappropriateinstrumenttraysorpouches (for Olympus instrument trays, see “Storage andHandling” section).

• Refertothesterilizer’sinstructionmanual.• Aeratetheinstrumentssufciently.

Conditions for Ethylene Oxide Gas Sterilization.Refer to ANSI/AAMI ST41 or DIN 58 948 forrecommendations and standards.Do not exceed the parameters outlined in the chart below.Gas concentration ........................................600–700 mg/lTemperature .............................................. 55 °C (130 °F)Pressure ....................................0.1–0.17 MPa (16–24 psi)Humidity .....................................................................55 %Exposure time ............................................................> 2 h

Aeration cycleat room temperature ...........................................7 daysin an aeration chamber ..................... 12 h at 50–60 °C

(122–135 °F)

Conditions for Low Temperature Steam and Formaldehyde Gas Sterilization (LTSF).Refer to EN 14180 or DIN 58 948-16.Do not exceed the parameters outlined in the chart below.Gas concentration ....................................................2–6 %Temperature .............................................. 60 °C (135 °F)Pressure ........................................max. 0.17 MPa (24 psi)Humidity ..................................................................> 70 %Exposure time ..........................................................> 1 hr.



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WARNING! Gas Sterilization is Toxic.Ethylene oxide and formaldehyde are toxic and may

present health hazards. Follow domestic health careregulations for compatibility of the processes. Aftersterilizing the instruments, aerate them to remove toxicresidues.

WARNING! Infection Control Risk.

Thoroughly clean and dry the instruments before gassterilization. Residual water may inhibit sterilization.





94


• Placetheinstrumentsinsterilizingpouchesorcontainers(anycontainer/pouchesmustbecertiedbyitsmanufacturer for STERRAD ® use).

• Refertothesterilizer’sinstructionmanual.NOTE! Different STERRAD systems with different cycles exist inthemarket.Whentheproduct-specicinstructionmanualor this manual provides information on STERRAD forOlympus products, this applies to the following cycles:- STERRAD 50: only one cycle exists- STERRAD 100S: short cycle

- STERRAD 200: short cycle- STERRAD NX: standard cycle- STERRAD 100NX: standard cycle

CAUTION! Risk of Discoloring in STERRAD Processes.Plasma sterilization may cause discoloring in somematerials (e.g., aluminium). However, this does not impairthe instrument’s function.

More information on the wear of a product and points toconsider are given in the material compatibility chart in theAppendix.



95


5.14 Storage and Handling

Ambient Conditions for Storage.

• Storetheequipmentinacleananddryconditionatroomtemperature (10–40 °C, 30–85 % humidity).• Donotexposetheequipmenttodirectsunlight.• DonotexposetheequipmenttosourcesofX-ray

radiation.• Donotstoretheequipmentinalocationwhereliquids

may splash.• Donotstoretheequipmentunderenvironmental

conditions such as:

- high atmospheric pressure- high or low temperatures- high or low humidity- direct ventilation- direct sunlight- dust- salty or sulfureous air

• Donotstoretheequipmentwherethereisariskofammablegases.

Preparation for Long-Term Storage.• Disassembletheinstrumentsaccordingtotheinstructionsprovidedintheproduct-specicinstructionmanualandthe Olympus Endoscopy System Guide (this manual).



96



• Storeelectricalunitsonaatsurface.Donotinclinetheunits. Make sure that units are not subjected to vibrationand impacts.

• Duringlong-termstorage,makesurethattheinstrumentsremain in a disinfected condition and are ready for theirnext use.

• Makesurethatcleanedand/orsterilizedinstrumentsdonot come in contact with contaminated instruments.

Instrument Trays.As the product’s transport packaging is not designedfor storage, do not store the product in the transportpackaging. Use instrument tray systems for storage (forOlympus instrument tray systems, see below).

Storage Life of Sterilized Instruments.The storage life of sterilized instruments depends on thetype of packaging and the storage conditions. Refer to

national and local laws and guidelines. Double sterilepackage according to DIN 58 946, Teil 9 prolongs thestorage life.

CAUTION! Handle with Care.Handle and store endoscopic equipment carefully. Do notsubject it to mechanical shocks such as impact or fall.Instrument damage may occur.



97


Plastic Instrument Trays.The Olympus instrument tray system made of plasticfeatures differently designed instrument trays:

- Instrument trays for telescopes (part of delivery of sometelescopes)- Universal instrument tray WA05970A- Universal insert trays for WA05970A- Customized insert trays for WA05970A

Procedure:• Opentheinstrumenttray’slid.• Chooseacompatibletrayinsert(onlyforinstrumenttrays

with tray inserts).• Placecompatiblesiliconematsintothetrayandthetray

insert (only for WA05970A, A5971, A5973).• Placethetrayinsertintotheinstrumenttray.• Placetheinstrumentsintotheinstrumenttray.Referto

the instrument tray’s instruction manual for a loadingchart.

• Closetheinstrumenttray’slid.• Beforesterilization,sealtheinstrumenttrayineitheran

appropriate sterilizing pouch or sterilization container.Refer to the “Steam Sterilization” section.

NOTE! Use of Instrument Trays.- Do not stack the instrument trays or load them on their

side edges during steam sterilization.- For steam sterilization, Olympus recommends a drying

time of at least 15–30 minutes.Choose an appropriate drying time, depending on thespecicsteamsterilizationunitinyourfacility.

- Users may want to consider the use of appropriate, lint-free absorbing cloth.



98


CAUTION! Risk of Damage.When loading instrument trays, always press telescopes

into the notches of the silicone bars as shown in theillustration.



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6 Service

6.1 The Olympus Organization Manufacturer of This Equipment.Ifthereisnootherstatementintheproduct-specicinstruction manual, items labelled with OLYMPUSGERMANY are manufactured by:Olympus Winter & Ibe GmbHKuehnstraße 6122045 Hamburg, Germany

Phone:.........................................................+49 40 66 96 60Fax: ......................................................+49 40 669 66 21 09

U. S. Distributor Olympus America Inc.3500 Corporate ParkwayP.O. Box 610Center Valley, Pennsylvania 18034-0610Phone:......................................................... (484) 896-5000

Fax: ............................................................. (484) 896-7128

U. S. Repair Center Olympus Medical Endoscopy Service America Inc.2400 Ringwood AvenueSan Jose, California 95131-1700Phone:......................................................... (408) 935-5000Fax: ............................................................. (408) 935-5010



100


Distributors in Other Countries.For addresses of distributors in other countries, pleasecontact

Olympus Winter & Ibe, or see the address list on our Website:www.olympus-owi.com

6.2 Repairs

Authorized Service Centers.

Repairsmayonlybecarriedoutbyqualiedservicingpersonnel which have been authorized byOlympus Winter & Ibe.Otherwise, Olympus Winter & Ibe can not be heldresponsible for the safety, reliability, and performance of theproduct.

WARNING! Effects on Patient and User Safety.

There is a risk of damage to the product if the user oran unauthorized servicing agency attempts repair of thedevice. A damaged device may cause injury of the patientor the user.

Loss of Warranty.Any guarantee or warranty claims towardsOlympus Winter & Ibe are forfeited if the user or anunauthorized servicing agency attempts repair of aninstrument.



101


Unauthorized repair (left) compared to authorized repairs(right).

Description of Defects.To enable the Service Center to perform repairs in atimely manner, send the product together with a detaileddescription of the damage or defect. The followingparticulars should be included:- Catalog number- Serial number or lot number (if possible)- Precise description of the malfunction- Delivery date- Invoice copy (for possible guarantee or warranty claims)- Internal order number of the customer (for correct

accounting of the repair order)

1.

2.

3.

4.

5.



102


Handling of Products Before Shipment.As a protective measure for the safety of the servicing staff,perform a complete cleaning and disinfection/sterilization

process before sending instruments for repair.If this is not possible, for example because furtherdisinfection or sterilization would damage the productcompletely, clean the product as thoroughly as possibleand mark it accordingly.Service Centers are entitled to refuse to repair soiled orcontaminated products for reasons of safety.

Shipment.

For transportation of the defective product use the originalcardboard packing. If this is not possible, wrap eachcomponentindividuallyinsufcientpaperorsheetsoffoamed material and place them in a cardboard box.Service Centers do not accept warranty claims for damagecaused by inadequate packaging.Telescopes should be shipped in an appropriate Olympusinstrument tray. Telescopes originally delivered witha protection tube should only be shipped inside this

protection tube.



103


7 Appendix

This chart lists cleaning, disinfection and sterilizationprocesses and agents that have been tested for materialcompatibility with products distributed byOlympus Winter & Ibe, Germany.This information only refers to material compatibility anddoes not indicate any germicidal effectiveness level.The following reprocessing information supplements thedetailedreprocessinginformationintheproduct-specicinstruction manual. However, if the information given in this

chapterdiffersfromthatintheproduct-specicinstructionmanual,usetheinformationgiveninproduct-specicinstruction manual.

CAUTION! Risk of Damage.Not every instrument is compatible with all processesmentioned in this manual. Before disinfecting or sterilizingtheinstrumentation,refertotheproduct-specicinstructionmanual.

+ Compatible (refer to the remarks below) – Not compatible▲Refertotheproduct-specicinstructionmanual♦ Compatibility not tested or evaluated

M a n u a

l c

l e a n

i n g a n d

d i s i n f e c t i o n

1 )

W a s

h e r / d

i s i n f e c t o r

( t h e r m a

l d i s i n f e c t i o n )

2 ) 4 )

S t e a m s t e r i l i z a t i o n

1 3 4 ° C

, 5 m

i n . ,

p r e v a

c u u m

S T E R R A D 5 0 / 1 0 0 S

S T E R R A D

2 0 0 / N X / 1 0 0 N X 3 )

P A A p r o c e s s e s

( m a n

u a

l

a n

d m a c

h i n e

)

Telescopes, autoclavable (sales before 2004) + + + + + –

Telescopes, autoclavable (sales since 2004) + + + + + +



104


M a n u a

l c

l e a

n i n g a n

d


1 )

W a s

h e r / d i s i n

f e c t o r

( t h e r m a

l d i s i n f e c t i o n

) 2 ) 4 )

S t e a m s t e r i l

i z a t i o n

1 3 4 ° C

, 5 m

i n . ,

p r e v a c u u m

S T E R R A D 5

0 / 1 0 0 S

S T E R R A D

2 0 0 / N X / 1 0 0 N X 3 )


( m a n u a

l

a n

d m a c

h i n e

)

OP telescopes, autoclavable (sales before 2004) + + + + + –

OP telescopes, autoclavable (sales since 2004) + + + + + +

Video telescopes, autoclavable (sales before 2004) + + + + + –

Video telescopes, autoclavable (sales since 2004) + + + + + +

Ureteroscopes, autoclavable + + + + – –Neuroscopes, autoclavable + + + + + –

Telescopes, non-autoclavable + – – – – –

Video adapters, autoclavable + + + + + –

Light-guide cables, standard (sales before 2004) + + + + + –

Light-guide cables, standard (sales since 2004) + + + + + +

Light-guide cables, uid + – – ♦ ♦ ♦

Light-guide cables, mechanical (without opticalelements)

+ + + + + –

Light-guide cables, optical (with lense/fber cone) + + + + + –

Resection sheaths, irrigation rings, cystoscope sheaths + + + + + –

Obturators + + + + + –

Bridges, optical obturators, working elements with/

without working channel

+ + + + – –

Working inserts with Albarran lever + + + + – –

Working elements (monopolar, bipolar, for knives, forprobes)

+ + + + + –

Attachments + + + + + –

HF-resection electrodes + + + + + –

HF electrodes, rigid + ♦ ▲ ▲ ♦ ♦

HF electrodes, exible + ♦ – + – –

Knives + + + + + –

Bladder syringes + + + – – –



105


M a n u a

l c

l e a

n i n g a n

d


1 )

W a s

h e r / d i s i n

f e c t o r

( t h e r m a

l d i s i n f e c t i o n

) 2 ) 4 )

S t e a m s t e r i l

i z a t i o n

1 3 4 ° C

, 5 m

i n . ,

p r e v a c u u m

S T E R R A D 5

0 / 1 0 0 S

S T E R R A D

2 0 0 / N X / 1 0 0 N X 3 )


( m a n u a

l

a n

d m a c

h i n e

)

Optical forceps + + + + – –

Hand instruments 3–9 Fr., exible/semi-exible + + + + + –

Trocar tubes, trocar spikes, valves, dilators, (thoraco-scopy/laparoscopy)

+ + + + – –

Reduction tubes, guiding tubes (thoracoscopy/laparo-

scopy)

+ + + + – –

Trocar tubes, trocar spikes, bridges (arthroscopy) + + + + + –

EKL probes + ♦ ♦ + + ♦

EHL probes + ♦ – ♦ ♦ ♦

Hand instruments, standard and monopolar (handles,shafts, jaws inserts)

+ + + + + –

Bipolar hand instruments (handles, shafts, jaws inserts) + + + + + –

Needle holders (handles, jaws inserts) + + + + + –

Suction/irrigation system (handle, valve tubing, suction/ irrigation tube)

+ + + + + –

Palpation probes, retractors, curettes + + + ▲ ♦ ♦

HF cables + + + + + –

Tubing, autoclavable + ♦ + ▲ ♦ ♦

Sealing caps and sealing rings + + + + + –

Instrument trays and insert trays + + + – – ♦

Instrument baskets, stainless steel + + + + + ♦Cleaning brushes + ♦ + ♦ ♦ ♦

Chrome-plated instruments 5) + + + – – –

Other products ▲ ▲ ▲ ▲ ▲ –



106


NOTE! Reprocessing methods may lead to increased wear of theproducts. The lifetime of the products may be reduced

using certain reprocessing methods.

Remarks.1) For more information on cleaning and disinfection,

contact your local Olympus representative.2) Thermal washer/disinfector with alkaline cleaning agent

with a pH value of up to 11 in the working solution3) Make sure to carefully inspect the products before each

reprocessing cycle. Carefully check the adhesives

and solders. If any changes occur, such as blistering,brittleness or maceration, do not use the productanymore.

4) Especially chrome-plated components may show areduced lifetime.

5) For all systems before OES Pro: If you are not surewhether your instrument is chrome-plated, contactOlympus for more details.

STERRAD ® is a registered trademark of its owner.



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Olympus System Guide

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