Olimpus - System Guide Endoscopy

7/27/2019 Olimpus - System Guide Endoscopy

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SYSTEM-RELATED

INSTRUCTION MANUAL

SYSTEM GUIDE ENDOSCOPY


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System GuideW7.052.800

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 Reprocessing ..................................................................454.1 General Policy ........................................................ 454.2 Reprocessing Procedures and Agents ...................474.3 Health and Safety at Work ......................................494.4 Decontaminating the Surface of Electrical Units .... 504.5 Preparation for Reprocessing at the Point of Use ... 514.6 Manual Cleaning ..................................................... 544.7 Ultrasonic Cleaning.................................................61

4.8 Manual Disinfection ................................................ 624.9 Automatic Cleaning/Disinfection .............................684.10 Maintenance ...........................................................714.11 Steam Sterilization .................................................. 744.12 Gas Sterilization ......................................................794.13 Other Sterilization Procedures ................................824.14 Storage and Handling .............................................84


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System Guide W7.052.800

5 Service .............................................................................895.1 The Olympus Organization .....................................895.2 Repairs ...................................................................90

6 Appendix..........................................................................93


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Introduction1

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)- A product-specic instruction manual

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,which are accompanied by a product-specic instructionmanual that references the Olympus Endoscopy SystemGuide.


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Product-Specic Instruction Manuals.Olympus products are supplied with their own product-specic instruction manual, which give all details necessary

for the use of the product (only very few products aredelivered without an instruction manual as they are self-explanatory).In some aspects, the product-specic instruction manualsonly 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 notapplicable to a certain product, specic information is given

in the product-specic instruction manual.

Latest Version of the Olympus Endoscopy SystemGuide.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.Before use, carefully read the product-specic instructionmanual, 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.Instruction manuals contain valuable specications, 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 OtherLanguages.The Olympus Endoscopy System Guide is available in thefollowing languages:.........................................................W7.052.815esky.................................................................W7.052.811

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

Latvieu..............................................................W7.052.820Lietuvi k............................................................W7.052.822Magyar ...............................................................W7.052.817Nederlands.........................................................W7.052.810Norsk (Bokml) ................................................. W7.052.818Polski .................................................................W7.052.823Portugus...........................................................W7.052.805Romn.............................................................W7.052.824.............................................................W7.052.814Slovensko...........................................................W7.052.819Suomi .................................................................W7.052.809Svenska .............................................................W7.052.808................................................................W7.052.813..............................................W7.052.816...................................W7.052.826................................................................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.

Potential Hazards and Signal Words1.1

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.

NOTEIndicates additional helpful information.


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Symbols1.2

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.

Prohibition.A circular band with a 45 diagonal slash from upper left tolower right is used to indicate prohibition.

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


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Quality Management1.3

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 managementsystem is regularly audited and certied by an independent

notied body (TV Rheinland).Since May 2001, Olympus Winter & Ibe has implemented acertied environmental management system according toDIN EN ISO 14001.


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Use of Endoscopic Equipment2

General Policy2.1

User Qualication.The user of endoscopic equipment must be a physician ormedical personnel under the supervision of a physician.The user must have received sufcient training in clinicalprocedures. 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.Properly reprocess all reusable equipment before rstand each subsequent use following the instructions

in this Endoscopy System Guide and in the product-specic instruction manual. Improper and/or incompletereprocessing can cause infection of the patient and/ormedical personnel.


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WARNING!Infection Control Risk with Sterile, Single-UseEquipment.

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-specic instruction manual. The section is headedCompatible 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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Inspection Before Each Use2.2

Before each use, perform the following inspection in

addition to that described in the products product-specicinstruction manual.

General Inspection. The product must be free of damage (e.g., dents, cracks,

bends). The product must be free of dirt. The product must be free of remaining cleaning agents or

disinfectants.

Make sure that no parts are missing or loose (e.g.,sealing rings, sealing caps).

Make sure that connecting elements between instrumentsfunction properly.

Inspect working channels for free passage. Make sure that all instrument parts/modules of an

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

Inspecting Telescopes. Inspect for debris on the objective window, the ocular

window and the light-guide connector. The telescopes image must not be cloudy, out of focus or

dark. Make sure that there is efcient light transmission from

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


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Inspecting Light-Guide Cables. Make sure that efcient light transmission is obtained.

If in doubt, compare the light-guide cables light

transmission with that of a new light-guide cable. Inspect for cuts or other damages to the cables outersleeve.

Visually inspect the connector to be plugged into the lightsource. Make sure that the cover glass is not damaged.

Inspecting HF Cables. Make sure that the cable is not broken. Make sure that the insulation is not defective. Make sure that connectors are not damaged (e.g., dents,

cracks, bents) and free of corrosion.


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Inspecting Electrodes. Make sure that contact surfaces are free of damage,

corrosion, and/or wear.

Make sure that the insulation is not damaged. Make sure that the HF-resection electrodes are securelyattached. To do so, hold the working element in onehand. With the other hand, hold the electrode guidingtube. Pull slightly at the electrode.

Make sure that the electrode moves smoothly and freelywithin the assembled instrument.


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Inspecting Hand Instruments. Make sure that the jaws and the handle move freely and

are properly attached to the instrument.

Make sure that the electrodes proximal part is not bent. Make sure that the shafts insulation is not damaged. Make sure that the jaws insert can be inserted smoothly

in the handle. Test scissors for cutting ability. Make sure that the sealing cap is not damaged (e.g.,

cracks).


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Wiring Video Equipment2.3

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 units 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. When using endoscopes with ber bundle optics (e.g.,berscopes, ureteroscopes), Y/C or RGB wiring isrecommended to prevent moir patterns.

Video Equipment: Troubleshooting2.4

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. Make sure that the camera control unit and monitor are

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

Do the power switch (ON) of the camera control unit andthe monitor illuminate?

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

Check wiring of camera control unit and monitor:Is the camera control units VIDEO OUT connectorconnected to the monitors VIDEO IN connector?

If the monitor features a selector for more than one videosignal source:Check the selector switch (e.g., LINE A, LINE B).Select the appropriate video signal source.

Set all monitor settings (brightness, color, contrast) to thedefault values.

Make sure that the camera heads connecting cable issecurely connected to the camera control unit.

Replace the video cable between the camera controlunit and the monitor with another cable to rule out cabledefects.

If the camera control unit features a color bar test chart,


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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. Turn the V-HOLD knob on the monitors rear panel until

the image becomes stable.

Blue Cast or Green Cast Image. Humidity may have intruded into the camera heads

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

Image Disappears Temporarily. Make sure that all cables and connectors are securely

connected. Visually inspect all cables for externally visible damage.

Image on the Monitor Screen Appears Dark. Make sure that the monitors brightness adjustment is

appropriate.If necessary, readjust the brightness.

Check the optical surfaces of the light-guide cable andthe telescopes light-guide cable connectors for debris.If necessary, clean the optical surfaces with a cottonswab moistened in 70 % alcohol (e.g., ethanol,isopropanol).

Replace the light-guide cable with a new one to rule outlight-guide defects.

Check the intensity setting of the light source.If necessary, readjust the intensity setting.

G

B


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Check the light sources lamp.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.

If the light source has any lters, make sure that theyhave been switched off.

Contact an authorized Service Center.

Color Reproduction not Satisfying.

Set all monitor settings (brightness, color, contrast) to thedefault values.

If the terminating impedance of any of the units in theimaging 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.

If the monitor features a selector for color temperature,select 6500 Kelvin.

Try to adjust the color reproduction using the cameracontrol units red and blue balancing functions.

If this does not help, perform a white balance on thecamera.Set the camera control units red and blue balancingfunction to the default setting.Point the endoscopes 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 endoscopes 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. Adjust the focus by turning the video adapters focussing

ring.

Check the connection of the telescope, video adapter andcamera head for proper attachment and secure xation. Check the optical surfaces of the telescope, 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. Check the imaging of the telescope itself.

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

Check the imaging of the camera head itself.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. Disconnect the telescope, video adapter and camera

head.

Make sure that the telescopes eyepiece cup, the videoadapter and the camera heads connecting thread are notdamaged.

Make sure that the eyepiece cup is securely xed to thetelescope.

Make sure that the video adapters xation mechanismsare not damaged and work properly.

Connect the telescope, video adapter and camera head.Make sure that all components are securely xed.

If the image is still out of center, contact an authorizedService Center.


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Energetic Applications3

Safety Precaution for Electro-Medical3.1Equipment

1. General.The following instructions, based on the NoticationNo. 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.In regard with specic safety precautions for particulartypes 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 arisk of ammable gases.

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 ofammable gases.

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 defectiveequipment and call qualied service personnel.

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.

For specic safety precautions of particular equipment,refer to the product-specic instruction manual.


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Light3.2

Energy Emission of Light Sources.

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

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

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

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

- Burns to the patients or users skin.- Burns or thermal damage to surgical equipment (e.g.,

surgical drapes, plastic materials, etc.).

Safety Precautions. Avoid prolonged exposure to intense illumination.

Use the minimum level of illumination necessary tosatisfactorily illuminate the target area.

Do not place the telescopes distal end or the light-guideconnector on the patients skin, on ammable materials,or on heat-sensitive materials.

Do not touch the telescopes distal end or the light-guideconnector.


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Turn the light source off when detaching the telescopefrom the light-guide cable.

Allow the telescope and the light-guide cable to cool

down after use.

Adapters on the Telescopes Light-Guide Connector.Light-guide adapters allow the telescope to be connected tolight-guide cables of various manufacturers.1. Olympus OES light-guide cable and Storz light-guide

cables2. Wolf light-guide cables3. Olympus OES Pro and ACMI light-guide cables

Adapters on the Light-Guide Cables Connector Plug.Light-guide adapters allow the light-guide cable to beconnected to light sources of various manufacturers. Thenested adapter A3200 allows the connection to an Olympuslight source. To use other adapters, remove adapter A3200and attach the required adapter.

CAUTION!

Risk of Loss in Light Transmission. When using screw-type adapters, make sure to screw the

adapter tightly onto the corresponding connector.

NOTE:Light-Guide Cable Adapters.Olympus recommends the use of an Olympus light-guidecable and an Olympus light source. Only this combinationwill guarantee optimum illumination of the endoscopicimage and excellent color reproduction.


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Interferences of Light Sources with ImagingEquipment.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 lightsources 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 lightsources and video systems, refer to the product-specicinstruction manuals.


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Testing the Light Sources Brightness ControlFunction. Move the endoscopes distal end towards an object.

The light emission from the telescopes distal end mustdecrease.

Move the endoscopes distal end away from an object.The light emission from the telescopes distal end mustincrease.


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HF Surgery3.3

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 patients 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). Place the patient plate close to the operational eld, if

possible on the upper arm or on the thigh. Make sure that the skin is free from hair and grease. When using a reusable patient plate, apply conductive gel

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

Make sure that contact has been established over theelectrodes entire surface.

Place the long edge of the patient plate towards theactive 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 patients 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. The patient must be insulated against all electrically

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

Ground the operating table. Place the patient on a dry, electrically insulating surface. Prevent any contact between different skin surfaces

(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 patients skin.Do not lay HF cables in loops.Use only plastic clips or hook and loop fasteners to x HF

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 units instruction manual.

Maximum Power Output.The maximum power output for the instruments islimited. Use the lowest possible output setting necessary.Always refer to the product-specic instruction manual forinformation on the output settings.

WARNING!Spray Coagulation.Some HF units have a so-called spray coagulationfeature.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 compatibilityof the instruments to be used is certied in their product-specic instruction manuals.

Safety Precautions for Monopolar Procedures.- Switch off the HF unit when not using it.- To coagulate tissue, rst position the electrode on the

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


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

Non-Flammable Gases.When performing electrosurgery, use only non-ammablegases (e.g., CO2) for insufation.

Irrigation Fluids.When performing monopolar electrosurgery, use only non-conductive uids.For TURis/TCRis, use only conductive uids.

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 workedsufciently but now does not satisfactorily coagulate thetissue, 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 electrodes 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-conductiveirrigation uid is used.- for TURis/TCRis interventions: a conductive irrigation uid

(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 patients 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 patients 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 heatof ignited uids or gases. They may also be caused byexplosions.Possible reasons are:


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- ignition of skin cleaning agents and disinfectants,- ignition of narcotic gases,- ignition of insufated gases (use only non-ammable

gases for insufation!),- 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 unitsinstruction 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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Laser Surgery3.4

The term laser stands for Light Amplication by

Stimulated Emmission 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 units 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 200400 nm (UV):

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

- in the range of wave lengths between 4001400 nm(visible light and near infrared): damage to the retina andthe eyes vitreous body,


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- in the range of wave lenghts between 1.41000 m(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. Aditionally, lasersin the range of wave lengths between 250320 nm arecarcinogenic.

Chemical Risks.Inammable or explosive substances may be ignited by a

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 aredesigned to lter out the lasers wavelength(s).- Patients eyes:Cover the patients eyes or use protective glasses that aredesigned to lter out the lasers wavelength(s).- Non-reective equipment:Do not use reecting equipment within the laser range. Allendoscopic instruments used in conjunction with the laser


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must be black or matted at the distal end.

WARNING!

Interferences with Insufators.Uncontrolled inow of gaseous insufation media maycause lethal embolisms. Besides the insufator, othersystems can act as gas supply sources. These mayinclude: lasers with probe tips cooled using CO2or othergases, and Argon-Enhanced Coagulation Systems (AEC).When using such systems in laparoscopic procedures,make sure to use an insufator with an active suctioncontrol system.

If the insufator emits a warning for intra-abdominal over-pressurization, quickly open the stopcock or valve of theinsufation instrument inserted into the patient.

WARNING!Inammable and/or Explosive Gases.Lasersurgical procedures may only be performed if non-ammable gases (CO2) are used for insufation.Do not perform lasersurgical procedures in areas where

ammable or explosive gases are present.In addition to anaesthetic agents, gases formed insidethe patients intestinal and urological tract represent anexplosion hazard.


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Reprocessing4

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 thedetailed reprocessing information in the product-specicinstruction manual. However, if the information given in this

chapter differs from that in the product-specic instructionmanual, use the information given in the product-specicinstruction manual.

General Policy4.1

The Reprocessing Cycle.

Olympus endoscopic instrumentation (if not labelled as asingle-use product) is to be reprocessed by the methodsdescribed in the product-specic instruction manual and inthis 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 ST35 Good Hospital Practice: Handling andBiological Decontamination of Reusable Medical Devices

Additional standards and regulations may be applicable.


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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 orautomatically with sufcient results. Manual cleaning

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

After Use.After use, immediately treat the instruments as describedin the product-specic instruction manual and in sectionPreparation 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.


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Reprocessing Procedures and Agents4.2

The materials and construction of the Olympus endoscopic

instrumentation may not be compatible with certainreprocessing methods.Olympus differentiates between two degrees ofcompatibility:- compatibility validated for microbiological efcacy- compatibility veried for material compatibility

Validated for Efcacy.Validated for efcacy means that the efcacy of the

procedure or agent has been validated for reprocessing aninstrument as described in the product-specic instructionmanual and in this manual.

Veried for Material Compatibility.Veried for material compatibility means that accordingto current knowledge the reprocessing procedure oragent does not negatively affect materials or functionalperformance of the instrument. Veried for material

compatibility does not mean that microbiological efcacycan be guaranteed.

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

Chosing a Reprocessing Agent.The actual cleaning or disinfection agent chosen by yourinstitution should be determined by national and localguidelines as well as your hospitals infection controlcommittee.


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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 of the disinfectants manufacturer to ensurethat the solution has not been diluted below its effectiveconcentration.To monitor sterilization processes, use an appropriateindicator.

Material Compatibility Chart.The material compatiblity chart in the Appendix of thisdocument lists those cleaning, disinfection, and sterilizationprocedures 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 proceduresmentioned in this manual. Before reprocessing aninstrument, read the product-specic instruction manual.For more details, contact an Olympus representative.


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Health and Safety at Work4.3

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-resistant gloves that t properly and are long enoughso 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.Alcohol stored in an open container is a re hazard and willlose its efcacy due to evaporation.


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Decontaminating the Surface of Electrical4.4

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. Turn off the power switch. Disconnect the power cable. Let the unit cool down to room temperature.

Remove all dust and debris with an appropriate, lint-freecloth which, if necessary, has been moistened.


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Disinfecting the Units Surface. To disinfect the unit, wipe it with a cloth that has been

moistened with a disinfection agent.

Refer to national or local guidelines regarding theapproval of using alcohol as disinfection agent. Select thedisinfection agent according to its eld of applications. Thedisinfection agent must be approved by the manufacturerfor the (surface) disinfection of medical devices and forthe material to be disinfected. Make sure not to exceed themanufacturers specication on temperature, contact timeand 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!

Preparation for Reprocessing at the Point4.5of 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. Separate single-use products from reusable products. Dispose of single-use products. Dispose of waste according to legal requirements. If necessary, sterilize waste before disposal.


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Reusable Products. Remove heavy debris from instruments by wiping with an

appropriate, single-use lint-free cloth.

Disassemble the instruments as described in the product-specic instruction manual. Do not use excessive force;this will damage the instruments.

Clean the active parts of HF electrodes and jaws ofmonopolar and bipolar forceps using 3 % hydrogenperoxide.

Remove the sealing caps. Open all stopcocks.

Hand instruments that cannot be disassembled:Flush the lumen of the hand instrument with water untilclear water ows from the hand instruments distal end.

Aq. dest.


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Separate telescopes from other instruments.

If desired, instruments can be immersed in cleaning ordisinfectant solution immediately after use.

Transport of Reusable Products. Transport reusable products from the point of use to the

reprocessing area.In general, the instrument can be transported wet ordry or immersed in liquids. Refer to the product-specicinstruction manual for exceptions. Contain reusable products during transport to avoid

possible environmental or personnel contamination.

If instruments are contained in dry condition, makesure that heavy debris does not dry. Start the followingcleaning procedure immediately after use. If thistime frame has to be exceeded, the user has to takenecessary measures to get an appropriate cleaningresult.

If instruments are contained immersed in liquids, start thefollowing cleaning procedure 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 to


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incrustations that may be difcult to remove.If instruments are left immersed in liquids for a longerperiod, the instrument may be damaged and the

instruments sealings may be damaged or fail.When using cleaning or disinfection agents, make sure notto exceed the manufacturers specication on temperature,immersion time and concentration.

Manual Cleaning4.6

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

Manual Cleaning Procedure. Immediately after use, disassemble the instruments as

described in the product-specic instruction manual.

Open all stopcocks.


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Thoroughly rinse all instrument components with water(< 20 C).

Remove persistent debris with a non-acidic cleaningagent that has been veried and approved by itsmanufacturer for cleaning medical endoscopes. Makesure to observe the instructions of the cleaning agentsmanufacturer.

Do not immerse instrumentation for more than 60 min.

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

To clean internal parts, use cleaning pistol, appropriatecleaning brushes, and cleaning wire. The availableOlympus products are described below.

Perform this procedure until all visual debris has beencompletely removed.

After cleaning the instrument, rinse it with deionized water(Aq. dest.). Do not immerse instrumentation for more than60 min.


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Let all parts of the instrument drain completely.

Use an appropriate soft single-use and lint-free cloth orsponge to wipe off remaining water.

Completely dry the instrument.

Cleaning Pistol O0190.

Select an appropriate attachment: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)

Immerse the instrument to be cleaned in water. Firmly press the attachment onto the nozzle port of the

cleaning pistol.


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Open the water tap. If berscopes are cleaned, do notexceed a maximum pressure of 0.5 bar.

Firmly press the cleaning pistol with the attachment

against the instrument to be cleaned (while submersedin water). Activate the handle several times until all debris is

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

Close the water tap after use.

Cleaning Brushes and Cleaning Wire. Select an appropriate cleaning brush/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 (57.5 Fr.), working

inserts, bridges, channels forguidance of resection electrodes

A0443.... 6 x 360 mm ......45 mm trocar tubes, sheaths(1517 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 (19.527 Fr.)A0446.... 4 x 360 mm ......sheaths (812 Fr.), shafts of HiQ

hand instruments with lengths of250 and 330 mm

A0447.... 12 x 360 mm ....sheaths (28.530 Fr.), 811 mmtrocar tubes

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


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A0449.... 16 x 360 mm ....1315 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

Immerse the instrument and the cleaning brush/wire intothe liquid in order to avoid splashing.

Introduce the cleaning brush/wire into the instruments

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

Move the cleaning brush/wire back and forth until thebrush/wire is free of visible debris.

Remove the cleaning brush/wire while the instrument andthe cleaning brush/wire are immersed in the liquid.

Check the channels lumen for free passage. If this is notthe case, repeat the procedure.

Clean and decontaminate the brush/wire after everysingle use. The cleaning brushes listed above areautoclavable.

Cleaning Optical Surfaces.Optical surfaces are:- a telescopes objective cover glass- a telescopes eyepiece cover glass- a telescopes light-guide connector- a camera heads lens window- the video adapters 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 Remove all adapters from the telescopes light-guide

connector. Remove all adapters from light-guide cables.


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Remove the telescopes eyepiece cup (if applicable). Clean the optical surfaces with a cotton swab that has

been moistened with 70 % alcohol (ethanol). Never wipe

with 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 and

local guidelines. There is an infection control risk whenusing insufcient cleaning agents.

WARNING!Insufcient Cleaning Efcacy.The cleaning efcacy may be compromised if thedetergent xes proteins to the instrument. For pre-cleaningor cleaning, use only detergents with good cleaningcharacteristics. Avoid any protein xation prior to or duringcleaning caused by the procedure.

WARNING!Risk of Reduced Cleaning Effectiveness in Instrumentswith 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 solutionsthat are certied by their manufacturers as safe forendoscopic 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 remove all residues, rinse the instrument thoroughly withdeionized water (Aq.dest.). Do not use tap water for rinsingbecause 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.


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

infectious agents. Always use a face screen 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 procedure to preventsplashing.

Ultrasonic Cleaning4.7

Ultrasonic Cleaning Procedure.Use only ultrasonic cleaners which have been approvedand veried (for example by FDA, DGHM or a comparableinstitution). Use only ultrasonic cleaners which themanufacturer has indicated may be used to cleanendoscopic instruments or a disinfectant suitable to be

used for ultrasound cleaning of endoscopes. Refer tothe instruction manual of the ultrasonic cleaner and thedisinfectant. Switch off the baths heating system. Only clean

components at room temperature. Depending on the degree of contamination, immerse

the instrument in an ultrasonic cleaner for 5 min. and amaximum of 15 min. at a frequency of 3847 kHz.Make sure not to exceed the manufacturers specicationon immersion and concentration.

Use grasping forceps for instruments O0185 with paddedjaws to remove instruments from the ultrasonic cleaner.

Rinse the instruments. Let all parts drain. Use an appropriate, lint-free cloth or sponge to wipe off

remaining uid. Completely dry the instrument.


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

infectious agents as aerosols. Always use a face screenand have adequate ventilation in place during ultrasoniccleaning.

WARNING!Insufcient Cleaning Efcacy.

The cleaning efcacy may be compromised if thecleaning agent xes proteins to the instrument. For pre-cleaning or cleaning, use only agents with good cleaningcharacteristics. Avoid any protein xation prior to or duringcleaning by the procedure.

Manual Disinfection4.8

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


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High-Level Disinfection.In the U.S., agents used to achieve high-level disinfectionare dened as liquid chemical germicides registered

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 solutions instructions or contact thesolutions manufacturer.The chemical agent used for disinfection should be capableof killing/deactivating:- Mycobacteria- Vegetative bacteria- Viruses (hepatitis, HIV, BPV etc.)- Fungi

- Bacterial spores

Disinfection Procedure. Create a disinfection solution according to general

practice and the specications of the disinfecting agentsmanufacturer.

Fill a disinfection tank (e.g., O0264) with disinfectantsolution.


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Remove the disinfection tanks sieve tray.

Disassemble the instrument.

Open the stopcocks.

Place the instruments components on the sieve tray.

Lower the sieve tray into the tank.

Make sure that all components have been completelyimmersed. Make sure that no air bubbles stick to theinstrument. Do not exceed the immersion time given bythe solutions manufacturer. In any case, do not exceedan immersion time of 1 hr. Make sure that all lumens arecompletely lled with disinfectant solution.


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To avoid damaging the instruments, use grasping forcepswith rubber-padded jaws (O0185) to handle instrumentsonce they are immersed.

Grasp telescopes, sheaths, and trocar tubes at their mainbody.

Rinsing. Make sure that the area in which the instrument is rinsed

is sterile. Thoroughly rinse all of the instruments components

with sterile deionized water (Aq.dest.) to remove alldisinfectant residues from the components. Make sure

that the components are not contaminated again. Always rinse instruments with small inner lumens using a

syringe. Connect the syringe to the instruments Luer-lockconnector, if applicable.

If non-sterile water is used for rinsing, wipe the instrumentcomponents and ush the channels with 70 % alcohol(ethanol).

Do not reuse rinsing water.

Drying. Dry the instruments with sterile appropriate, lint-free

cloths or sponges. Use instruments immediately after disinfection.

70%

EtOH


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WARNING!Risk of Reduced Disinfection Effectiveness inInstruments with Small Lumen.

If instruments with small lumen are disinfected, there isa risk that the inner lumen is not soaked with disinfectantsolution. When disinfecting instruments with small innerlumen, disinfectant solution must be injected into the smalllumen using a syringe.

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

damage Olympus endoscopes and accessories. Use onlysolutions that are approved and veried (for example byFDA, DGHM or a comparable institution) and that arecertied by their manufacturers as safe for endoscopicinstrument 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 14 % (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 solutionsmanufacturer. 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 andImmersion Time.

For information about the concentration and immersiontime, refer to the instructions given by the disinfectantsolutions manufacturer. Do not exceed the manufacturersmaximum 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 all disinfectant residues, rinse the instrumentthoroughly with (sterile) deionized water (Aq.dest.).


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Automatic Cleaning/Disinfection4.9

Automatic cleaning procedures are reproducible,

standardizable and feature a validated cleaning process.

Appropriate Washer/Disinfectors.Use only washer/disinfectors which are intendedspecically for cleaning and disinfection of endoscopicinstruments by the washer/disinfectors manufacturer. Useonly washer/disinfectors according to international standardseries ISO 15883. Refer to the washer/disinfectorsinstruction manual.

Selection of Programs.For all thermostable rigid endoscopes, use a programthat complies with ISO 15883-1. This program must atleast reach an A0value of 3000 and must not exceed atemperature of 93 C during the disinfection phase. Thetemperature of the rst inlet water must not exceed 20 Cin order to avoid coagulation of proteins during the pre-rinsephase. During cleaning, a temperature of 55 C must not

be exceeded in order to achieve optimum cleaning results.After neutralization, rinsing cycles ensure that no residualcleaning or neutralizing agents remain and affect the nextreprocessing step. Completely deionized water must beused for the nal rinse and disinfection. Refer to the tableon water and steam quality in the Steam Sterilizationsection. In order to avoid the formation of condensates, remove all

instrument parts from the machine immediately after theprogram is completed.

If necessary, dry the instruments.


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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. Make sure that all instruments have been securely

xed to the units trays or baskets. Make sure that theinstruments do not touch each other.

For telescopes, use adequate instrument trays to x thetelescope.


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Instruments with lumens must be attached to specialtrays with irrigation devices or directly to the Luer-lockconnectors of the machine. Refer to the table on water

and steam quality in the Steam Sterilization section.Make sure that all lumens are sufciently irrigated. Checklumens for free passage before starting the procedure.

Open all stopcocks. Open the jaws of hand instruments. Do not overload the washer/disinfector. To prevent corrosion, remove the instruments from

the washer/disinfector immediately after the automaticprocedure has stopped.

Cleaning/Disinfection Agents in Automatic Cleaning.Use only agents that are certied by their manufacturers assafe for surgical instrument cleaning/disinfection.Make sure not to exceed the specication of agentsmanufacturer.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 endoscopesmaterial (especially on older chromium-plated instruments).However, if rinsing with neutralizers after cleaning/disinfection is necessary, make sure to remove all tracesof neutralizers by using a nal rinsing cycle that employsdeionized water.To remove all cleaning/disinfection residues, rinsing cyclesmust be run using deionized water (Aq.dest.) Refer to thetable on water and steam quality in the Steam Sterilizationsection. Do not use tap water for rinsing because it mightbe chlorinated. For further information on agents forautomatic cleaning/disinfection processes, please contactOlympus.


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WARNING!Infection Control Risk with Cleaning Agents.Use only veried cleaning agents which feature validated

processes in accordance with national and local guidelines.There is an infection control risk when using insufcientcleaning agents.

CAUTION!Reduced Cleaning Effectiveness in Automatic Cleaningdue to Coagulation of Proteins.Preferably return the instruments from the point of use tothe cleaning area in dry condition to avoid protein xation

caused by cleaning agents or disinfectants. Refer to theproduct-specic instruction manual.Make sure that the rst water inow into the washer-disinfector starts with cold temperatures (< 20 C) to avoidthermal coagulation of proteins.

CAUTION!Risk of Damage due to Elevated Concentration ofCleaning/Disinfection Agents.

Defects of the washers/disinfectors feeding pump cancause an exceeded concentration of cleaning/disinfectionagents, which will damage the instruments. Regularlymaintain the washer/disinfector as recommended by itsmanufacturer.

Maintenance4.10

Inspection. Visually inspect all parts. If necessary, clean them again.

Instruments should be regularly treated with lubricants tomaintain their function and to protect them from corrosionand aging.


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Lubricants. Different sterilization processes require different kinds

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 imaging quality.

Moving Metal Parts.Lubricate moving metal parts in joints or attachmentdevices. Apply a drop of oil to all parts to be lubricated. Use a cotton pad to remove excess oil.


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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: Detach the knurled nut on the cock plug. Remove the cock plug. Thoroughly clean all components. Lightly grease the cock plug with stopcock grease (cat.

no. O0170). Reinsert the cock plug.

Fasten the knurled nut.

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


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Silicone Sealings. Apply oil A0273 to sealing rings.

Steam Sterilization4.11

If possible, Olympus recommends using fractionatedprevacuum steam sterilization. Steam sterilizationwith prevacuum has been validated for its germicidaleffectiveness with most of the Olympus endoscopes andaccessories. Refer to the product-specic instructionmanual for compatibility with steam sterilization.

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


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Steam Sterilization Procedure. Disassemble the instrumentation.Refer to the product-specic instruction manual for

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

Open all stopcocks.

Place the instruments in appropriate instrument trays orpouches (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 the sterilization effect.

Refer to the autoclaves instruction manual.

Use only prevacuum autoclave cycles to ensure thatsteam lls all lumens.

After steam sterilization, let the instrument cool downgradually 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.

Make sure that the sterile package of the instruments isnot 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 for 5min. at 134 C with fractionated prevacuum.

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


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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 ........................................................ 10 mg/lSiO........................................ 0.1 mg/kg............... 1 mg/lFe ........................................... 0.1 mg/kg............ 0.2 mg/lCd ...................................... 0.005 mg/kg........ 0.005 mg/lPb......................................... 0.05 mg/kg.......... 0.05 mg/l

Traces of heavy metals(except Fe, Cd, Pb) ................ 0.1 mg/kg............ 0.1 mg/lCl.......................................... 0.1 mg/kg............... 2 mg/lPO....................................... 0.1 mg/kg............ 0.5 mg/lConductivity (at 25 C) ............ 3 S/cm........... 5 S/cmpH ...................................................... 57 ...................57.5Appearance.............................. colourless ............colourless clear ....................clear without residues ..without residues

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


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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 1530 minutes.Choose an appropriate drying time, depending on thespecic steam sterilization unit in your facility.

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

Gas Sterilization4.12

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

The information given in this section describes theinstruments material compatibility. It does not describethe microbiological efcacy of the procedure on theinstruments.

Gas Sterilization Procedure. Disassemble the instruments according to the instructions

provided in the product-specic instruction manualand and the Olympus Endoscopy System Guide (thismanual).


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Open all stopcocks.

Place the instruments in appropriate instrument trays orpouches (for Olympus instrument trays, see Storage andHandling section).

Refer to the sterilizers instruction manual. Aerate the instruments sufciently.

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 ........................................ 600700 mg/lTemperature .............................................. 55 C (130 F)Pressure ....................................0.10.17 MPa (1624 psi)Humidity .....................................................................55 %Exposure time ............................................................> 2 h

Aeration cycle at room temperature ...........................................7 days in an aeration chamber ..................... 12 h at 5060 C (122135 F)

Conditions for Low Temperature Steam andFormaldehyde Gas Sterilization (LTSF).Refer to EN 14180 or DIN 58 948-16.Do not exceed the parameters outlined in the chart below.Gas concentration ....................................................26 %Temperature .............................................. 60 C (135 F)Pressure ........................................max. 0.17 MPa (24 psi)Humidity ..................................................................> 70 %Exposure time ..........................................................> 1 hr.

Documents

Olimpus - System Guide Endoscopy