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Appendix

Vedlegg:

Anhang

Electromagnetic Compatibility (EMC)

Information

Hinweise zur elektromagnetischen

Verträglichkeit (EMV)

Merknader om elektromagnetisk

kompatibilitet (EMC)

Tabell 201

Retningslinjer og produsenterklæring – Elektromagnetisk stråling

Det fleksible CMOS video-cysto-uretroskopet 11272 V/VU i forbindelse med monitoren 8402 ZX er bestemt for drift i omgivelser som er beskrevet under.

Brukeren av utstyret bør sørge for at systemet brukes i slike omgivelser.

Interferensmålinger

Overensstemmelse

Elektromagnetiske omgivelser – Retningslinjer

HF-utslipp

iht. CISPR 11

Gruppe 1

Det fleksible CMOS video-cysto-uretroskopet 11272 V/VU sammen med

monitoren 8402 ZX bruker HF-energi kun for interne funksjoner. HF-utslippet er

derfor veldig lavt, og det er usannsynlig at elektroniske enheter i nærheten vil bli

forstyrret.

HF-utslipp

iht. CISPR 11

Stemmer overens

med klasse B

Det fleksible CMOS video-cysto-uretroskopet 11272 V/VU i forbindelse med

monitoren 8402 ZX er egnet for bruk i andre innretninger enn boligområdet, og

slike som er tilkoblet umiddelbart på et offentlig strømnett som også forsyner

bygg som benyttes til boligformål.

Generering av oversvingninger

iht. IEC 61000-3-2

Klasse A.

Kan ikke brukes

Generering av spenningssvingninger/flimring

iht. IEC 61000-3-3

Oppfylt

Содержание 11272 V

Страница 1: ...Urethroscope Series 11272 V VU VK VUK Monitor 8402 ZX GEBRAUCHSANWEISUNG Flexibles CMOS Video Cysto Urethroskop Serie 11272 V VU VK VUK Monitor 8402 ZX BRUKSANVISNING Fleksibelt CMOS video cysto uretr...

Страница 2: ...zation of the CMOS Video Cysto Urethroscope All essential details of the equipment and all actions required on your part are clearly presented and explained We thus ask that you read this manual caref...

Страница 3: ...5 10 1 Holding correctly 17 5 10 2 Handling the shaft 17 5 10 3 Handling the deflection mechanism 18 5 10 4 Handling the working channel 19 5 10 5 Handling the accessories forceps cleaning brushes HF...

Страница 4: ...43 6 6 4 Drying 43 6 7 Machine cleaning and disinfection 44 6 7 1 Manual preparation 44 6 7 2 Connecting 44 6 8 Assembly inspection and care 45 6 9 Packaging systems 46 6 10 Sterilization 46 6 10 1 Hy...

Страница 5: ...hkeit EMV 58 17 Niederlassungen 72 15 Disposal 54 16 Appendix 55 16 1 Troubleshooting 55 16 2 Accessories 57 16 3 Electromagnetic Compatibility EMC Information 58 17 Subsidiaries 72 15 Kassering 54 16...

Страница 6: ...4...

Страница 7: ...ningselementer Bedienungselemente a e c g f d s d f 2 h i j p q p o i o a n l k m 13242 XL Dichtigkeitspr fer Leakage Tester Lekkasjetester 11025 E Druckausgleichskappe Pressure Compen sation Cap Tryk...

Страница 8: ...tip h Leakage tester 13242 XL i Pressure compensation cap 11025 E j Monitor k Power supply connection l Video output for connecting an external monitor m CMOS Video Cysto Urethroscope connection n Res...

Страница 9: ...n Follow the instruction manual White balance Single image capture Video recording This device has been marked in accordance with the European Directive 2002 96 EC on waste electrical and electronic e...

Страница 10: ...indications relating directly to the product The flexible CMOS Video Cysto Urethroscope must not be used if in the opinion of the responsible physician such an application would endanger the patient e...

Страница 11: ...sicht macht darauf aufmerksam dass bestimmte Wartungs oder Sicherheits ma nahmen zu treffen sind um eine Besch di gung des Instrumentes zu vermeiden 1 HINWEIS Hinweise enthalten spezielle Informatione...

Страница 12: ...ination permit this Pay careful attention to the instructions and interface specifications of medical products used in combination WARNING The flexible CMOS Video Cysto Urethroscope is delivered unste...

Страница 13: ...rranty for flexible CMOS Video Cysto Urethroscopes that are repaired by unauthorized personnel WARNING The instructions Cleaning Disinfection Care and Sterilization of KARL STORZ Instruments must be f...

Страница 14: ...regarding this warning can endanger the patient and user WARNING If the flexible CMOS Video Cysto Urethroscope should malfunction during application on a patient stop the application immediately Place...

Страница 15: ...tal tip of the flexible CMOS Video Cysto Urethroscope against hard objects and never use a sharp object to remove dirt CAUTION Never lay heavy objects on the flexible CMOS Video Cysto Urethroscope CAU...

Страница 16: ...K with the following accessories 1x Carrying case 27677 FV 1x Instruction manual 1x Leakage tester 13242 XL 1x Pressure compensation cap 11025 E 1x Grasping Forceps 5 Fr 27023 FE 1 Biopsy Forceps 5 Fr...

Страница 17: ...tromagnetische Vertr glichkeit Dieses Ger t wurde gepr ft und entspricht den EMV Grenzwerten gem EN IEC 60601 1 2 CISPR 11 Class B 5 5 Electromagnetic compatibility This device has been tested and is...

Страница 18: ...scopes or damaged accessories must not be used 5 9 Handhabung 1 HINWEIS Besch digungen des flexiblen CMOS Video Cysto Urethroskops die aufgrund von Fehlbe dienungen entstehen fallen nicht unter die Ge...

Страница 19: ...s approved by KARL STORZ please see www karlstorz com If during use the image fails is disturbed or becomes blurred or if vision in general is impeded put the deflection mechanism into the neutral pos...

Страница 20: ...he patient the distal tip must be put into the neutral position as otherwise injuries to the patient or damage to the instrument may occur 3 WARNING If the distal tip can no longer be properly control...

Страница 21: ...nstruction manuals for the particular devices The irrigation devices recommended by KARL STORZ are set to a maximum pressure of 54 kPa 400 mmHg 0 54 bar 7 8 psi Use the LUER adapter 27014 Y to seal th...

Страница 22: ...pply a watersoluble lubricant to the tip thereof Then insert again Before removing the instrument from the patient the distal tip must be in a straight position Forceps scissors and other accessories...

Страница 23: ...RNING When HF electrodes or laser probes are used it must be ensured that power is only applied when there are no flammable gases in the operating field or in the proximity of the flexible CMOS Video...

Страница 24: ...or sharp corners CMOS Video Cysto Urethroscopes with sharp corners may not be used 2 CAUTION When the distal tip is deflected do not introduce any instrument into the flexible CMOS Video Cysto Urethro...

Страница 25: ...e Bewegung des Ablenkhebels erreicht Je nach Bewegungsrichtung vorne oder hinten wird das distale Ende abgewinkelt Anderenfalls k nnen schwerwiegende Verletzungen des Patienten oder des Anwenders veru...

Страница 26: ...ZX verwendet werden Die Ge brauchs anweisung des Monitors muss beachtet werden 3 WARNUNG Es ist sicherzustellen dass elektrisch nicht isolierte Teile des Endoskops auf keinen Fall mit leitf higen Ober...

Страница 27: ...ollleuchte a leuchtet Sollen Einzelbilder oder ein Videostream gespeichert werden so muss eine SD Speicherkarte in die Halterung t eingesetzt werden 1 HINWEIS Um eine schnelle Dokumentation zu gew hrl...

Страница 28: ...p of the video endoscope at a white surface and hold the button for 2 sec Single image capture f Saves the live image on the screen on the SD memory card s d f 3 WARNUNG Das flexible CMOS Video Cysto...

Страница 29: ...n the SD memory card which has been inserted into the slot t Stop video recording Stops the recording of a video stream Video recording not possible No SD card inserted or loading in process Single im...

Страница 30: ...gs Plays back and deletes recorded video streams on the SD memory card which has been inserted into the slot t Viewing recorded images Views and deletes recorded single images on the SD memory card wh...

Страница 31: ...es the video After deletion the list of video recordings is shown Play Plays back the video recording Pause Pauses the video Stop Stops play back and activates the list of recordings Video selection m...

Страница 32: ...list Scrolls downward through the list to select the saved images Delete Pressing the button for an extended period deletes the image Stop Stops play back and activates the list of recorded images Pho...

Страница 33: ...e can be adjusted Next Activates the function keys for the fifth level Back Returns to Top Level functions Fifth level functions Versions It displays the version number of the installed firmware FW ve...

Страница 34: ...ey displays keys to enter the day then confirm using the arrow key Enter month and year accordingly Clock Allows to enter or correct the clock time Pressing the softkey displays the keys to enter the...

Страница 35: ...G 4 Codec installiert ist Einzelbildspeicherung Durch Bet tigung der Funktionstaste Einzelbildspeicherung am Monitor oder am flexiblen CMOS Video Cysto Urethroskop f wird der aktuelle Bildschirminhalt...

Страница 36: ...usfall des Bildes oder Bildst rungen w hrend des Einsatzes im Patienten die distale Spitze in die neutrale Stellung bringen und sanft und behutsam aus dem K rper des Patienten ziehen Wird trotz Ausfal...

Страница 37: ...e used for approx one hour when fully loaded The discharged battery is fully charged after 5 hours when the unit is switched off Whilst charging the orange colored LED i lights up If the system has no...

Страница 38: ...der t and carefully pushed downward in order to activate the reset button r The system will now be rebooted Release the holder in the desired position The selected position is fixed by the holder s ba...

Страница 39: ...ction Leakage test Manual preparation Connecting Chemical disinfection Steam sterilization Sterrad 100S Long Cycle with Booster Sterrad NX Advanced Cycle Sterrad 100 NX Flex Cycle Sterrad 100 NX DUO C...

Страница 40: ...RNING Before reusing the device replace any defective parts or send the flexible endoscope for repair 2 CAUTION The pressure compensation cap must be in place on the vent port for sterilization and tr...

Страница 41: ...n and equivalent organizations striving to ensure personal safety must be observed 1 NOTE Observe the chemical manufacturer s specifications concerning concentration and exposure times Bear in mind th...

Страница 42: ...euticals must be removed from the endoscope immediately after use Wipe clean the exterior surfaces of the endoscope with a damp cloth Rinse out the working channel in order to prevent drying 1 NOTE To...

Страница 43: ...bilizing the pressure on the manometer wait at least 2 minutes to see whether the pressure remains constant or drops 6 5 2 Performing the leakage test in liquid 1 NOTE To avoid damage from the penetra...

Страница 44: ...Manual reprocessing 6 6 1 Manual cleaning The endoscope must be completely immersed in a cleaning solution The suction and working channel must be covered with no air bubbles by filling in a targeted...

Страница 45: ...level disinfectant solution The working and suction channel must be covered with no air bubbles by filling in a targeted manner At the end of the necessary exposure time as specified by the manufactur...

Страница 46: ...forth within the channel Finally it must be rinsed with cold water to ensure neutralization 1 NOTE KARL STORZ recommends using the adaptors 11301 CD1 and 11014 RA for simpler filling of the lumina 6...

Страница 47: ...d disinfection procedure once more 1 NOTE Clean the distal lens with a cotton tip applicator soaked in lens cleaner or 70 isopropyl alcohol When cleaning the distal lens always wipe with a circular mo...

Страница 48: ...ien und in Absprache mit den Ger te und Produktherstellern erfolgen 3 WARNUNG Vor der Sterilisation m ssen alle Teile des Endoskops gr ndlich gereinigt desinfiziert und gesp lt sowie getrocknet werden...

Страница 49: ...ieses Medizinprodukt validiert und freigegeben STERRAD 100S Long Cycle mit Booster STERRAD NX Advanced Cycle STERRAD 100NX Flex Cycle STERRAD 100NX DUO Cycle 6 10 2 Wasserstoffperoxid H2O2 Sterilisati...

Страница 50: ...national requirements KARL STORZ only recommends dust protected suspended storage for decontaminated endoscopes Horizontal storage is possible for sterilized endoscopes KARL STORZ recommends the use o...

Страница 51: ...e distal tip is 5 50 mm in diameter and houses the CMOS video module The distal tip of the flexible CMOS Video Cysto Urethroscope can be deflected 210 up or 140 down The handle houses the deflection l...

Страница 52: ...93 mm Speicherkarte SD Monitor Betriebs Lagerbedingungen Betriebsbedingungen 0 C bis 40 C 30 bis 70 rel Feuchte Lagerbedingungen 20 C bis 50 C 5 bis 95 rel Feuchte Lade Netzger t 40150031 Versorgungss...

Страница 53: ...Video Cysto Urethroskop 11272 V VU VK VUK Blickrichtung 0 ffnungswinkel 120 Abwinkelung auf 210 ab 140 Nutzl nge 37 cm Au endurchmesser 15 5 Charr Arbeitskanal 7 Charr Beleuchtung integrierte LED Lich...

Страница 54: ...entive maintenance is not essential Regular maintenance can contribute to identifying potential problems before they become serious enhancing the instrument s reliability and extending its useful oper...

Страница 55: ...its performance Any such opening repair or modification performed during the warranty period shall void all warranty 13 Richtlinienkonformit t Nach Medical Device Directive MDD 11272 V VU VK VUK Medi...

Страница 56: ...u entsorgen Hierzu erfragen Sie bitte die f r Sie zust ndige Sammelstelle bei KARL STORZ SE Co KG einer KARL STORZ Niederlassung oder Ihrem Fachh ndler Im Geltungsbereich der Richtlinie ist KARL STORZ...

Страница 57: ...ting fibers damaged Solution Send flexible CMOS Video Cysto Urethroscope to KARL STORZ for repair Mulig rsak Lysoverf rende fibre er skadet L sning Send det fleksible CMOS video cysto uretroskopet til...

Страница 58: ...out correctly Solution Carry out new white balance Possible reason TFT screen defective Solution Send TFT screen to KARL STORZ for repair Possible reason Incorrect color setting on the monitor Solutio...

Страница 59: ...rements w x d x h 30 x 20 x 10 cm Crossbar for stands 8401 YA 50 cm x diameter 25 mm for positioning the monitor 8402 ZX Crossbar for stands 8401 YA 70 cm x diameter 25 mm for positioning the monitor...

Страница 60: ...ysto Urethroscope 11272 V VU in conjunction with monitor 8402 ZX is a Group 1 unit as per CISPR 11 Group 1 contains all the equipment and systems which generate or use RF energy only for their interna...

Страница 61: ...upr fen WARNING The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment WARNING The use of accessories other than those specified in the KARL STORZ...

Страница 62: ...Geb ude versorgt die zu Wohnzwecken benutzt werden Aussendung von Oberschwin gungen nach IEC 61000 3 2 Klasse A Nicht anwendbar Aussendungen von Spannungs schwankungen Flicker nach IEC 61000 3 3 Erf...

Страница 63: ...ingslinjer HF utslipp iht CISPR 11 Gruppe 1 Det fleksible CMOS video cysto uretroskopet 11272 V VU sammen med monitoren 8402 ZX bruker HF energi kun for interne funksjoner HF utslippet er derfor veldi...

Страница 64: ...in die Qualit t der Versorgungs spannung mit einem Netzfilter weiter zu verbessern Sto spannungen Surges nach IEC 61000 4 5 1 kV Gegentaktspannung 2 kV Gleichtaktspannung Stimmt berein 1 kV Gegentakts...

Страница 65: ...lter the power quality by using an AC line filter Surge acc to IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies 1 kV differential mode 2 kV common mode Mains power quality should be that...

Страница 66: ...de vanlige forretnings eller sykehusomgivelsene N r det oppst r bildeforstyrrelser kan det v re n dvendig forbedre kvaliteten p forsynings spenningen enda mer med et nettfilter St tspenninger surges...

Страница 67: ...en Angaben des Senderherstellers und d als empfohlenem Schutzabstand in Metern m Die Feldst rke station rer Funksender sollte bei allen Frequenzen gem einer Untersuchung vor Ort a geringer als der ber...

Страница 68: ...er in watts W according to the transmitter manufacturer and d is the recommended separation in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a sho...

Страница 69: ...d P som nominell sendereffekt i watt W i henhold til senderprodusentens opplysninger og d som anbefalt sikkerhetsavstand i meter m Feltstyrken for stasjon re radiosendere b r v re under samsvarsniv et...

Страница 70: ...m Ger t abh ngig von der Ausgangsleistung des Kommunikationsger ts wie untenangegeben einh lt Nennleistung des Senders W Schutzabstand d m abh ngig von der Sendefrequenz 150 kHz bis 80 MHz C 80 MHz bi...

Страница 71: ...below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance d m according to frequency of transmitter 150 kHz to 80 MHz...

Страница 72: ...ere og apparat avhengig av utgangseffekten for telekommunikasjonsutstyret som er oppf rt overholdes Nominell effekt for senderen W Beskyttelsesavstand d m avhengig av sendefrekvensen 150 kHz til 80 MH...

Страница 73: ......

Страница 74: ...storz com TOV LLC KARL STORZ Ukraine Avenue Geroyiv Stalingrada Str 2D office 717 Kyiv 04210 Ukraine Phone 38 095 000 895 0 38 097 000 895 0 38 073 000 895 0 E Mail marketing karlstorz com ua KARL STO...

Страница 75: ......

Страница 76: ...KARL STORZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Tel 49 07461 708 0 Fax 49 07461 708 105 E Mail info karlstorz com Web www karlstorz com...

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