SYSTEM GUIDE ENDOSCOPY

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SYSTEM GUIDE ENDOSCOPYSYSTEM-RELATED INSTRUCTION MANUALCaution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Contents1 Introduction. 51.1 Potential Hazards and Signal Words. 61.2 Symbols. 72 Use of Endoscopic Equipment. 82.1 Inspection Before Each Use. 93 Energetic Applications. 133.1 Safety Precaution for Electro-Medical Equipment. 133.2 Light. 153.3 HF Surgery. 193.4 Laser Surgery. 294 Indications and Contraindications. 324.1 Arthroscopy. 324.2 ENT (Ear, Nose, Throat). 324.3 Hysteroscopy. 334.4 Laparoscopy/Thoracoscopy. 354.5 Urology. 385 Reprocessing. 405.1 General Policy. 405.2 Reprocessing Procedures and Agents. 415.3 Health and Safety at Work. 435.4 Decontaminating the Surface of Electrical Units. 435.5 Preparation for Reprocessing at the Point of Use. 445.6 Manual Cleaning. 475.7 Ultrasonic Cleaning. 555.8 Manual Disinfection. 565.9 Automatic Cleaning/Disinfection. 615.10 Maintenance. 655.11 Steam Sterilization. 675.12 Gas Sterilization. 715.13 Other Sterilization Processes. 735.14 Storage and Handling. 746 Service. 786.1 Repairs. 78

7 Appendix. 81

1 IntroductionOlympus instructions for use have been prepared to provide theuser with all the necessary knowledge about the safe use ofOlympus endoscopes and their related accessories.For further questions about how to use the products, about theproducts’ safety, or about this or other Olympus documents, feelfree to contact your local Olympus representative or visit ourwebsite atwww.olympus-oste.euProduct-specific instructions for useOlympus products are supplied with product-specific instructionsfor use, which give all details necessary for the use of theproduct.Some product-specific instructions for use make reference tothe “System Guide Endoscopy”. In these cases, all the relatedinformation given in the “System Guide Endoscopy” is applicableto the product.If the information given in the “System Guide Endoscopy” is notapplicable to a certain product, specific information is given in theproduct-specific instructions for use.System Guide EndoscopyThe system-related instructions for use “System GuideEndoscopy” combine information on those topics that apply tomany instruments. Therefore, the “System Guide Endoscopy”must be considered as part of the instructions for use.The “System Guide Endoscopy” applies to all productsmanufactured or distributed by Olympus Winter & Ibe, Germany,that reference to the “System Guide Endoscopy”. To make sure that you use the most recent version of the“System Guide Endoscopy”, check our website (www.olympusoste.eu).Carefully read all instructions for use Before use, carefully read the product-specific instructions foruse, the “System Guide Endoscopy” (this document), and allinstructions for use pertaining to additional equipment used inthe procedure.5

Follow all instructions given in these documents.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 equipmentUse of instructions for useInstructions for use contain valuable specifications, care, andproblem-solving information which will help ensure safe andeffective operation of the equipment. Keep instructions for use in a safe, accessible location.1.1 Potential Hazards and Signal WordsOlympus instructions for use include safety information whichhelp the user to identify potential hazards and to avoid them.Olympus instructions for use highlight potential hazards by usingthree signal words:-- Danger-- Warning-- CautionIn addition, the signal word Note has been introduced for helpfulinformation.DANGERIndicates an imminently hazardous situation which, if not avoided,may result in death or serious injury.WARNINGIndicates a potentially hazardous situation which, if not avoided,could result in death or injury.CAUTIONIndicates a potentially hazardous situation which, if not avoided,may result in minor or moderate injury.This signal word may also be used to highlight unsafe practicesor potential equipment damage.6

NOTEIndicates additional helpful information.1.2 SymbolsPotential hazards, mandatory actions, prohibitions, and useractions are illustrated using the same symbol shapes throughoutthe “System Guide Endoscopy”.Hazard alertAn equilateral triangle is used to convey hazard alert messages,regardless of their hazard level. Hazard level is conveyed by useof the appropriate signal word as described above.Mandatory actionsA solid color circle is used to signify a mandatory action.ProhibitionA circular band 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.7

2 Use of Endoscopic EquipmentUser qualificationThe user of endoscopic equipment must be a physician ormedical personnel under the supervision of a physician. Theuser must have received sufficient training in clinical procedures.Olympus instructions for use do not explain or discuss clinicalprocedures.Spare equipment Always have spare equipment available in order to replace theequipment in case of a malfunction.WARNINGInfection control risk with reusable equipmentImproper and/or incomplete reprocessing can cause infection ofthe patient and/or medical personnel. Properly reprocess all reusable equipment before first and eachsubsequent use following the instructions in this “System GuideEndoscopy” and in the product-specific instructions for use.WARNINGInfection control risk with sterile, single-use equipmentThe equipment is delivered in a sterilized condition. Use only if the package is undamaged. Only open the package immediately before use. Do not use the equipment after its expiration date (if anexpiration date is given). Dispose of expired equipment according to national and locallaws and guidelines.Instrument compatibilityThe combinations of equipment and accessories that can beused with a certain product are listed in their product-specificinstructions for use. The section is headed “CompatibleComponents” or “Compatible Equipment”.New products released after the introduction of a product mayalso be compatible for use. For details, contact Olympus.8

WARNINGRisk of injury or equipment damageUsing incompatible equipment can result in patient injury and/orequipment damage.If combinations of equipment other than those listed in the“Compatible Components” section are used, the full responsibilityis accepted by the user.2.1 Inspection Before Each UseBefore each use, perform the following inspection in addition tothat described in the product’s product-specific instructions foruse.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 ordisinfectants. Make sure that no parts are missing or loose (e.g., sealingrings, 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 instrumentsystem are assembled correctly and properly fixed (e.g.,electrodes, knives, etc.).Inspecting telescopes Inspect for debris on the objective window, the ocular windowand the light-guide connector.9

The telescope’s image must not be cloudy, out of focus or dark. Make sure that there is efficient light transmission from thelight-guide connector to the distal end. If in doubt, compare thetelescope’s light transmission with that of a new telescope.Inspecting light-guide cables Make sure that efficient light transmission is obtained. If indoubt, compare the light-guide cable’s light transmission withthat of a new light-guide cable. Inspect for cuts or other damages to the cable’s outer sleeve. 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.10

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 one hand. Withthe other hand, hold the electrode guiding tube. Pull slightly atthe electrode. Make sure that the electrode moves smoothly and freely withinthe assembled instrument.11

Inspecting hand instruments Make sure that the jaws and the handle move freely and areproperly attached to the instrument. Make sure that the electrode’s proximal part is not bent. Make sure that the shaft’s insulation is not damaged. Make sure that the jaws insert can be inserted smoothly in thehandle. Test scissors for cutting ability. Make sure that the sealing cap is not damaged (e.g., cracks).12

3 Energetic Applications3.1 Safety Precaution for Electro-Medical Equipment3.1.1 GeneralThe following instructions, based on the Notification No. 495issued by the Pharmaceutical and Supply Bureau of the Ministryof Health and Welfare, Japan, June 1, 1972, describe generalprecautions which should be taken in the use of electro-medicalequipment to ensure the safety of the patient, operator andsurroundings.In regard with specific safety precautions for particular types ofequipment, refer to the individual operation manuals.3.1.2 Installation1. The equipment should not be installed in a location on whichliquids may splash.2. Avoid environmental conditions that are likely to be adverselyaffected by atmospheric pressure, temperatures, humidity,ventilation, sunlight, dusty, salty or sulfureous air, etc.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 a riskof flammable gases.5. The AC mains to which the equipment is connected shouldsupply a power appropriate for the input frequency, ratedvoltage and amperage of the equipment.6. Check the conditions of batteries (discharge, polarity, etc.)7. Earth the equipment effectively.13

3.1.3 Before use1. Check electrical contacts of switches, polarity, dial setting,indicators, etc. and make sure that the equipment functionsproperly.2. Make sure that the equipment is earthed effectively.3. Make sure that all cords are connected correctly andsecurely.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 the patient.6. Check the batteries.3.1.4 During use1. A prolonged use or a dosage more than necessary fordiagnosis and treatment may compromise patient safety.2. Keep an eye continuously on the equipment at large as wellas the patient for abnormality.3. If any abnormality with the equipment or the patient isdetected, take appropriate measures, e.g. by stopping theequipment in such a matter that it does not impair the patientsafety.4. Pay attention so that the patient does not come into contactwith the equipment. 3.1.5 After use1. After setting control switches, dials, etc. back to the homeposition in accordance with the procedures as prescribed,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-- The equipment should not be stored in a location on whichliquids may splash.14

-- Avoid environmental conditions that are likely to be adverselyaffected by atmospheric pressure, temperatures, humidity,ventilation, sunlight, dusty, salty or sulfereous air, etc.-- Exercise care so that the equipment is neither inclined norsubjected to vibration and impacts.-- Do not store the equipment where there is a risk of flammablegases.4. After accessories, cords, leads, etc. have been cleaned,arrange them neatly, then put in storage.5. During storage keep the equipment clean and ready for nextuse.3.1.6 Service and maintenance1. If any failure has developed, leave repairs to the specialist.Attach appropriate information to the defective equipmentand call qualified service personnel.2. The user should not modify the equipment.3. Maintenance and inspection-- Inspect the equipment and accessories periodically.-- When using the equipment after an extended period of time,make sure it functions normally and safely.For specific safety precautions of particular equipment, refer tothe product-specific instructions for use.3.2 LightEnergy emission of light sourcesLight sources emit large amounts of light energy and thermalenergy.As a result:-- The light-guide connector and the telescope’s distal endbecome extremely hot.-- The light energy is concentrated in a relatively small area.15

Risks related to light sources-- Thermal injury to the patient’s tissue (e.g., from prolongedexposure to the intense illumination in cavities with smalllumens, or if the telescope’s distal end is placed into closeproximity with the tissue).-- Burns to the patient’s or user’s skin.-- Burns or thermal damage to surgical equipment (e.g., surgicaldrapes, 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 telescope’s distal end or the light-guideconnector on the patient’s skin, on flammable materials, or onheat-sensitive materials. Do not touch the telescope’s distal end or the light-guideconnector. Turn the light source off when detaching the telescope from thelight-guide cable. Allow the telescope and the light-guide cable to cool down afteruse.16

Adapters on the telescope’s light-guide connectorLight-guide adapters allow the telescope to be connected to lightguide 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 cablesAdapters on the light-guide cable’s connector plugLight-guide adapters allow the light-guide cable to be connectedto light sources of various manufacturers. The nested adapterA3200 allows the connection to an Olympus light source. To use other adapters, remove adapter A3200 and attach therequired adapter.CAUTIONRisk of loss in light transmission When using screw-type adapters, make sure to screw theadapter tightly onto the corresponding connector.17

NOTELight-guide cable adaptersOlympus recommends the use of an Olympus light-guidecable and an Olympus light source. Only this combination willguarantee optimum illumination of the endoscopic image andexcellent color reproduction.Interferences of light sources with imaging equipmentVideo systems feature different brightness control functions, suchas an electronic shutter and an auto focus function.These mechanisms control the brightness of the video image onthe monitor screen but do NOT control the light source’s output.In the case of improper settings of the camera and light source,the light source might be set to full power output, although this isnot visible on the monitor screen.Such improper settings lead to enhanced heat emission at thetelescope. For further information on the proper connection of lightsources and video systems, refer to the product-specificinstructions for use.Testing the light source’s brightness control function Move the endoscope’s distal end towards an object.The light emission from the telescope’s distal end mustdecrease.18

Move the endoscope’s distal end away from an object.The light emission from the telescope’s distal end mustincrease.3.3 HF SurgeryAn electrical current applied to biological tissue generates threeeffects:-- a thermical effect, generating heat-- a Faraday effect, stimulating nerves and muscles-- an electrolytical effect, causing movement of ionsEffects of HF currentIn HF surgery, the Faraday effect is avoided by using highfrequency alternating current with a frequency of more than300 kHz. This current only generates heat. This heat can be usedfor three types of application:-- thermal coagulation of tissue-- cutting of tissue-- vaporisationIn thermal coagulation, the electrical current heats the tissue onlyslowly. The water inside the tissue evaporates slowly and cellularproteins are denaturated, thus resulting in coagulation of thetissue.19

For cutting tissue, the electrical current heats the tissue veryquickly. The temperature of the tissue inside the cells increasesquickly and the intracellular water evaporates, destroying cellmembranes.For vaporisation, the electrical current is set to high values. Theintracellular water evaporates immediately, resulting in shrinkedtissue and a large coagulation zone for TURis or TCRis.Bipolar HF surgeryIn bipolar HF surgery, the electrosurgical current passes betweenthe two electrodes of the instruments (e.g., the jaws of a bipolarforceps). On the small surface between both electrodes, a highcurrent density accumulates, which creates enough heat tocoagulate and/or cut tissue.As a result, bipolar HF surgery only requires electrosurgicalcurrent to be conducted over a very short distance through thepatient’s body.20

Monopolar HF surgeryI HFAPI HFIn monopolar HF surgery, the electrosurgical current passesfrom the point-shaped “active” electrode (A in the diagram) tothe larger “patient plate” (P). On the small surface of the activeelectrode, a high current density accumulates, which createsenough heat to coagulate, cut and/or vaporize tissue.Active electrodes as described in this “System Guide Endoscopy”are:-- all HF electrodes-- HF-resection electrodes (in resectoscopes)-- monopolar hand instruments (e.g., monopolar forceps andscissors)Other terms used for

The “System Guide Endoscopy” applies to all products manufactured or distributed by Olympus Winter & Ibe, Germany, that reference to the “System Guide Endoscopy”. To make sure that you use the most recent version of the “System Guide Endoscopy”, check our website (www.olympus-oste.eu). Carefully read all instructions for use

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