膀胱鏡及附件說(shuō)明書1_W

1、INSTRUCTIONS注冊(cè)單元名稱：膀胱鏡及附件 TelescopesA22000A, A22001A, A22002A, A22003A, A22004A, A22005ACaution! Observe Information given in the Olympus Endoscopy System Guide.Immediately contact an Olympus representative if the System Guide has not been delivered.2General InformationIntended use.This product has

2、been designed for endoscopic diagnosis and treatment in urological and gynecological applica- tions.Do not use it for any other purpose.A22000A, A22001A, A22002A, A22003A, A22004A, A22005AMedical use. This product is to be used only in a medical facility by trained medicalpersonnel.+Thecomplete inst

3、ruction manual set for this product consists of this product- specific instruction manual (delivered together with this product) and the system-related instruction manual, entitled “Olympus Endoscopy System Guide” (supplied separately).Immediately contact an Olympus rep- resentative if either manual

4、 is missing or lost.Keep the instruction manual set in a safe, accessible location.34WARNING!Read all instruction manuals thoroughly. Before use, read this manual, the Olympus Endoscopy System Guide, and the manuals for all other equipment which will be used during the procedure.An insufficient unde

5、rstanding of the dangers, warnings, cautions, and infor- mation in these manuals can resultin death, serious injury, or equipment damage.Medical Device Directive (Europe). This product complies with the require- ments of Directive 93/42/EEC concern- ing medical devices.A22000A, A22001A, A22002A, A22

6、003A, A22004A, A22005A0197Upon DeliveryInspect immediately. Make sure that the shipping case contains all of the items listed below. Contact your Olympus representative or an authorized service center if any items are missing or damaged.Contents. Instrument tray A5990 Telescope Instruction manual56U

7、npacking. Remove the instrument from the packaging. Do not use the packaging for routine storage. Open the instrumenttray. Remove the transport safeguard from the telescopes proximal end. Remove the telescope from the instrument tray.7最大插入部外徑4.05 mm 280 mm0?12?30?70?110?30?WA22000A A22001A A22002A A

8、22003A A22004A A22005A8TerminologyTelescope. Light guide connector Connector pin Eyepiece cupColor code.Color Green Blue Red Yellow OrangeDirectionofview0?12?30?70?110?Technical DataDimensions.Max Insertion Portion Width 4.05mmWorking length280 mmOptical system.Direction of view A22000A A22001A A220

9、02A A22003A A22004A A22005A0?12?30?70?110?30?W910A22000A A22001A A22002A A22003A A22004A A22005AAR-TF2 AR-TL AR-T2 AR-TZ AR-TX AR-TF08E AR-TL08E MH999E MH999SA0460AA03200AA3290, A3291 A3292, A3293 A3294, A3295, A3296, A3297, A3298, A3093Compatible ComponentsWARNING!Risk of injury to the patient and/

10、or user.Use only compatible equipment as list- ed in this section.If other combinations are used, the full responsibility is assumed by the user. Future products may also be compat- ible. For further details contact an Olympus representative.11A2264 A2964A22002AA2297 A0460 O033212A22001A A22002AA276

11、0A2754A2761A2755A2749*A2757A2750*A22060AA2751*A22061AA2752A22063AA2753A22065AA3550A3661 A2363*A22001AA2255 A2263A2256 A2264A2257 A2962 A2966 A2261 A2963 A2967 A2262 A2965A2971* A2972* A2973* A2974*A2975* A2271 A2273 A2275A2279 A2280 A2290A22003A A22004AA2291*Notavailable intheU.S.13A2120 A2630* A220

12、93AA2131A2132A2133 A2631A2632A2633 A2634A2922*A2923* A2924*A2925*A2221 A2222A2223A2224 A2225A4722A22071AA22072A A22073A A22091A A42071A A42091AA22000A A22001A A22002A A22003AA472314A22003AA3655A3656A3652A3658A3661A3651A2363A22001A A22002A A22003A A22005AA22007A*Notavailable intheU.S.15A2930*A2230A29

13、31*A2231A22001A A22002A A22003A A22005AA2264 A2964A22002AA229716A4678 A4679A4766A4765A4764A22002A A22005AA4760 A4761 A47610A17A4678 A4679A4766A4765A22001AA4764A4760 A4761 A47610AA22001AA47671819Before UseWARNING!Infection control risk. Properly repro- cess the product before first and each subsequen

14、t use following the instruc- tions in this manual and in the Olympus Endoscopy System Guide. Improper and/or incomplete reprocess- ing can cause infection of the patient and/or medical personnel.CAUTION!Risk of damaging the instrument. This telescope is a precise optical device. Make sure that this

15、product is handled with extreme care.Inspection and TestingInspecting the product. Visually inspect the product. Make sure that it has:- no corrosion- no dents- no scratchesCheck image quality. A piece of wri- ting held at approximately 15 mm from the objective lens must be clearly visi- ble through

16、 the telescope.Damaged product. If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center.2021UseBefore use. Make sure that the prod- uct has been properly reprocessed, inspected, and tested.Preparation Attach the telescope. Insert the

17、 telescope through the tele-scope channel of a compatible instru- ment. Make sure that the connector pin clicks securely into position.Connect the A03200A light-guide cable to a telescope. Connect the light-guide cable to the telescopes light-guideconnector. Connect the light-guide cable to a compat

18、ible Olympus light source.Connect the light-guide cable to a telescope (not for A03200A). Attach a compatible light-guide adapter to the telescopes light-guide connector. Connect the light-guide cable to the telescopes light-guideconnector. Connect the light-guide cable to a compatible Olympus light

19、 source.22Adapters on the light-guide connec- tor. Light-guide adapters allow the tel- escope to be connected to light-guide cables of various manufacturers.Olympus recommends the use of an Olympus light-guide cable and an Olympus light source.Onlythiscombination will guarantee optimum illumination

20、of the endoscopic image and excellent color reproduc- tion.Olympus OES 4000, StorzWolfACMIPDD. When using the telescope in photo- dynamic diagnosis, attach the A22007A adapter to the telescopes eyepiece cup (refer to the adapters instruction manual).ProcedureOperation. Insert the telescope into appr

21、opriate diagnostic or therapeutic system (hysteroscope, cystoscope, resecto- scope). Insert into patient. Perform any necessary distention or irrigation. Perform the procedure.2324WARNING!Injury and damage from thermal exposure. Light sources emit large amounts of energy. As a result:- The light-gui

22、de connector and the telescopes distal end become extremely hot.- The light energy is concentrated in a relatively small area.Risks:- Thermal injury to the patients tissue (e.g. from prolonged exposure to the intenseilluminationincavitieswith small lumens, or if the telescopes distal end is placed i

23、nto close prox- imity with the tissue).- Burns to the patients or users skin.- Burns or thermal damage to surgical equipment (e.g. surgical drapes, plastic materials, etc.).Countermeasures:- Avoid prolonged exposure to intense illumination.- Use the minimum level of illumination necessary to satisfa

24、ctorily illuminate the target area.- Do not place the telescopes distal end or the light-guide connector on the patients skin, on flammable materials, or on heat-sensitive materials.- Do not touch the telescopes distal endorthelight-guideconnector.- Turn the light source off when detach- ing the tel

25、escope from the light-guide cable.- Allow the telescope and the light- guide cable to cool down after use. 2526After UseReprocessing. Immediately bring the product to the reprocessing area. Reprocess the product following the instructions in this manual and in the Olympus Endoscopy System Guide.2728

26、ReprocessingWARNING!Infection control risk. Properly repro- cessthe productbeforefirstandeach subsequent use following the instruc- tions in this manual and in the Olym- pus Endoscopy System Guide. Improp- er and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.

27、Observe the following instrument spe- cific instructions.Information in this section. The fol- lowing reprocessing information sup- plements that in the Olympus Endos- copy System Guide.However, if the information given in this section differs from that in the Olympus Endoscopy System Guide, use the

28、 information given here.2950/100/100S30Compatible reprocessing methods. This product is compatible with the re- processing methods listed in the table. Fordetailsoftheprocedures,referto the Olympus Endoscopy System Guide.+ compatible- incompatible Manual or automatic cleaning Ultrasonic cleaning Dis

29、infection or high-level disinfection Steam sterilization (autoclaving) Heat sterilization (dry) Gas sterilization (ETO) Gas sterilization (formaldehyde) STERRAD 50/100/100S STERISCAUTION!Risk of damaging the product. Do not use incompatible reprocessing methods. Product damage may occur.CleaningDisa

30、ssemble light-guide adapter. If applicable, disassemble the tele- scopeslight-guide adapter before reprocessing.31A22000A, A22001A, A22002A, A22003A, A22004A, A22005AA5990 WA05990A Manual or automatic cleaning+- Ultrasonic cleaning- Disinfection or high-level disinfection+- Steam sterilization (auto

31、claving)+ Heat sterilization (dry)- Gas sterilization (ETO)+ Gas sterilization (formaldehyde)+ STERRAD 50/100/100S+- STERIS+-3233CAUTION!Risk of damaging the telescope. Always clean each telescope separate- ly. Do notclean withother telescopes or other instruments.MaintenanceCAUTION!Decrease of imag

32、ing quality. Apply all lubricants sparingly. Make sure that the telescopes objective or eyepiece lens windows are not smudged with lubricant.Lubricants on objective or eyepiece lens windows considerably decrease viewability and imaging quality.Sterilization Instrument tray A5990. Open the instrument

33、tray. Inserttheinstrumentintotheinstru- ment tray as shown in the illustration. When loading the instrument tray, press the instrument into the notches of the silicone bars as shown in the illustration. Close the instrumenttray. Before sterilization, seal the instru- ment tray in packaging appropria

34、te forsterilization according toyour hospitals protocol.34RepairPolicy. Contact your Olympus repre- sentative or an authorized service cen- ter for repair and warranty information.Repair guidelines. Follow the general repair guidelines in the Olympus Endoscopy System Guide.35生產(chǎn)者名稱： 奧林巴斯葦音特和意北公司Kuehn

35、str. 61, 22045 漢堡，德國(guó) Kuehnstr. 61, 22045 Hamburg Germany生產(chǎn)場(chǎng)所地址：Kuehnstr. 61, 22045 漢堡，德國(guó) Kuehnstr. 61, 22045 Hamburg Germany中國(guó)境內(nèi)售后服務(wù)單位：奧林巴斯(北 京)銷售服務(wù)有限公司地址 北京市朝陽(yáng)區(qū)新源南路 1-3 號(hào)平安國(guó)際金融中心 A 座 8 層電話EG.NO.: SFDA(I)20113222825產(chǎn)品標(biāo)準(zhǔn): YZB/GER 3241-2011 膀胱鏡及附件 Manufacturer: OLYMPUS WINTER & IBE GMBHK

36、uehnstr. 61, 22045 Hamburg, GermanyPhone: +49 40 669 66-0 Distributors: OLYMPUS MEDICAL SYSTEMS EUROPA GMBHWendenstra?e 14-18, 22097 Hamburg, GermanyFax: +49 40 237 73 - 656 Phone: +49 40 237 73 - 0KEYMED LTD.KeyMed House, Stock Road, Southend-on-Sea, Essex, SS2 5QH, United Kingdom Fax: +44 1 702 465 677 Phone: +44 1 702 616 333OLYMPUS LATIN AMERICA, INC.6100 Blue Lagoon Drive, Suite 390, Miami, FL 33126-2087, U.S.A. Fax: +1 305-26 14 421 Phone: +1 305-266 23 32OLYMPUS AUSTRALIA PTY.LTD.31 Gilby Road, Mount Waverly VIC 31