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Intended Use

Namjenska upotreba

Bestimmungsgemäße Verwendung

Bestimmungsgemäße

Verwendung

Fiberskope werden in der diagnostischen und

operativen Endoskopie verwendet. Sie dürfen

nur durch entsprechend ausgebildetes und

qualifiziertes Fachpersonal eingesetzt werden.

Indikationen:

Untersuchung, Diagnose und/

oder Therapie in Verbindung mit endosko

pischem Zubehör in verschiedenen medizinischen

Fachbereichen.

Kontraindikationen:

Es sind keine Kontraindi

kationen bekannt, die sich direkt auf das

Produkt beziehen. Das Fiberskop darf nicht

angewendet werden, wenn nach Meinung eines

verantwortlichen Arztes eine solche Anwendung

eine Gefährdung des Patienten hervorrufen würde,

z. B. aufgrund des Allgemeinzustandes des

Pa tienten, oder die endoskopische Methode als

solche kontraindiziert ist.

3.1

Sicherheitsmaßnahmen beim

Einsatz der Fiberskope

Der Einsatz der Fiberskope muss in

Übereinstimmung mit den für endoskopische

Verfahren anerkannten medizinischen Regeln und

Verfahrensweisen der Endoskopie erfolgen.

Intended Use

Fiberscopes are used in diagnostic and surgical

endoscopy. They must only be used by

appropriately trained and qualified technical staff.

Indications:

Examination, diagnosis and/or ther

apy in conjunction with endoscopic accessories in

various medical fields.

Contraindications:

No contraindications are

known which directly relate to the product. The

fiberscope must not be used if, in the opinion of

a qualified physician, such an application would

endanger the patient, e.g., due to the patient’s

general condition, or if the endoscopic method as

such is contraindicated.

3.1

Safety precautions when using

the fiberscopes

Fiberscopes must be used according to the

medical rules and procedures of endoscopy

recognized for this method.

Bestimmungsgemäße
Verwendung

Namjenska upotreba

Fiberskopi se upotrebljavaju u dijagnostičkoj i

operativnoj endoskopiji. Smije ih upotrebljavati

samo odgovarajuće osposobljeno i kvalificirano

stručno osoblje.

Indikacije:

Pregled, dijagnoza i/ili terapija u

kombinaciji s endoskopskim priborom u različitim

stručnim poljima medicine.

Kontraindikacije:

Nisu poznate kontraindikacije

koje su izravno povezane s proizvodom. Fiberskop

ne smije se upotrebljavati ako bi prema mišljenju

odgovornog liječnika takva primjena bila opasna

za pacijenta, npr. zbog općeg stanja pacijenta, ili je

endoskopska metoda kao takva kontraindicirana.

3.1

Sigurnosne mjere pri primjeni

fiberskopa

Fiberskopi se moraju se za endoskopske postupke

upotrebljavati u skladu s priznatim medicinskim

pravilima i načinima postupanja u endoskopiji.

Содержание 110 Series

Страница 1: ...Fiberskope Serien 110xx 111xx 112xx 113xx 13304C Fiberscopes Series 110xx 111xx 112xx 113xx 13304C Fiberskopi Serije 110xx 111xx 112xx 113xx 13304C ...

Страница 2: ......

Страница 3: ... 1 Priključivanje vodova za napajanje 24 10 2 Upravljanje distalnim vrhom 25 10 3 Usisavanje 26 10 4 Insuflacija 26 10 5 Fokusiranje 26 10 6 Kanal instrumenta 27 10 7 PDD izvedba 27 11 DCI fiberskop s kamerom 28 11 1 Montaža 28 11 2 Rastavljanje 29 12 DIN okular na DCI fiberskopu 29 12 1 Montaža 29 12 2 Rastavljanje 29 13 DCI kamera na DIN okularu 30 13 1 Montaža 30 13 2 Rastavljanje 30 14 Obrada ...

Страница 4: ...14 9 1 Sterilizacija vodikovim peroksidom H2O2 ASP STERRAD 44 14 9 2 Sterilizacija vodikovim peroksidom H2O2 STERIS V PRO 44 14 9 3 Sterilizacija etilen oksidom EO 45 14 9 4 Kemijska niskotemperaturna sterilizacija peroctenom kiselinom STERIS sustav 1E 46 14 10 Ograničenje ponovne obrade 46 14 11 Skladištenje 46 14 12 Obrada pribor 47 14 13 Pregled četke za čišćenje 48 15 Normativno 49 15 1 Poprav...

Страница 5: ... Fiberskope Direct Coupled Interface Telescope Telescope with special filters for PDD AF DCI fiberscopes Direct Coupled Interface Vielen Dank für Ihr Vertrauen in den Namen KARL STORZ Auch in diesem Produkt steckt unsere ganze Erfahrung und Sorgfalt Sie und Ihr Haus haben sich damit für moderne und hochwertige Instrumente der Firma KARL STORZ entschieden Die vorliegende Gebrauchsanweisung soll hel...

Страница 6: ...6 Photographs of the unit Fotografije uređaja Geräteabbildungen DCI PDD OPT 1 Geräteabbildungen 1 Photographs of the unit 1 Fotografije uređaja ...

Страница 7: ...re compensation and leakage tester connection Suction outlet Light inlet piece Instrument channel Objective lens Light outlet Instrument in instrument channel PDD filter changer ALA for special tumor marker based on aminolevulinic acid W for white light AF autofluorescence mode Image waveguides Light cable Locking mechanism secures the tip PDD DCI Fokusni prsten ako postoji Umetak usisnog ventila ...

Страница 8: ...en für Instrumentenkanal Packung mit 10 St wieder verwendbar 11301CB Absaugventileinsatz wiederverwendbar 5917800 Dichtungsring Absaugventileinsatz 6885391 Kappe Absaugventileinsatz 5923110 Feder Absaugventileinsatz 6927791 Gehäuse Absaugventileinsatz 8567290 Stößel Absaugventileinsatz 11301CE Absaugventileinsatz für Einmal gebrauch Packung mit 20 Stück 11301D1 LED Batterielichtquelle mit Feinschr...

Страница 9: ...green 11301HH Adaptor for leakage test in BHT cleaning machines 11301FF2 Adaptor for leakage test in ETD2 ETD3 cleaning machines with nonreturn valve 11301GG2 Adaptor for cleaning the working channel in ETD2 ETD3 machines 11301KK2 Connecting adaptor for cleaning the working channel in ETD3 cleaning machines 6011590 LUER cap 13242 XL 11301 CD 11301 HH 11301 FF2 11301 BM 11301 KK2 11301 GG2 6011590 ...

Страница 10: ...CI adaptor for connecting endoscopes with DIN eyepiece to DCI camera heads 20260031 DCI eyepiece adaptor for connecting DCI telescopes to camera heads with mounts for DIN eyepieces 39107ALK Cleaning adaptor for use with small LUER stopcocks 20260030 20260031 20260030 DCI adapter za priključivanje endoskopa s DIN okularom na DCI glave kamere 20260031 DCI okularni adapter za priključivanje optika DI...

Страница 11: ...tion diagnosis and or ther apy in conjunction with endoscopic accessories in various medical fields Contraindications No contraindications are known which directly relate to the product The fiberscope must not be used if in the opinion of a qualified physician such an application would endanger the patient e g due to the patient s general condition or if the endoscopic method as such is contraindi...

Страница 12: ...ication KARL STORZ fiberscopes may only be used by persons with an appropriate medical qualification and who are acquainted with the endoscopic technique The information given in these instructions only serves to instruct in the correct handling cleaning disinfection and sterilization of the fiberscopes It is not intended as an introduction to the endoscopic technique 4 Kvalifikacije korisnika Fib...

Страница 13: ...ifies important information WARNING Before using the fiberscope read the following safety instructions carefully to avoid putting your patients personnel or yourself at risk WARNING Inspect the fiberscope prior to each surgical procedure to ensure that it is functioning correctly and that it has been correctly cleaned disinfected and where applicable sterilized WARNING This equipment may not be us...

Страница 14: ...used in combination WARNING Lengthy direct contact between the endoscope tip and surrounding tissue may cause tissue damage due to the potentially high temperatures on the tip of the endoscope and must thus be avoided WARNING The fiberscope is delivered unsteril ized and must therefore be cleaned disinfected and where applicable sterilized prior to initial use and each subsequent reuse ATTENTION T...

Страница 15: ...HINWEIS Beschädigungen des Fiberskopes die aufgrund von Fehlbedienungen entstehen fallen nicht unter die Gewährleistungsansprüche HINWEIS Bei der Entsorgung oder dem Recyc ling von Komponenten sind die jeweils geltenden Bestimmungen einzuhalten HINWEIS Falls sich Instrumentarium im Arbeits kanal befindet kann durch dessen zusätzliche Steifigkeit die Ablenkung eingeschränkt sein NOTE Any damage to ...

Страница 16: ...achines green 11301 CD 1 Cleaning brush for inner diameter 1 2 1 5 mm 11093x 50 for inner diameter 2 0 2 3 mm 11094x 50 for inner diameter 2 6 3 0 mm 11095x 50 for 2 8 x 50 and for 2 8 x 70 27651 A for 3 7 x 65 27651 AL for 5 0 x 65 27651 B for 5 6 x 65 27651 C for 6 4 x 65 27651 C 1 Biopsy forceps only bronchofiberscopes 11001 KL 1 Grasping forceps only bronchofiberscopes 11002 KS 1 Three way dou...

Страница 17: ...sories 1 Suction valve insert reusable version 11301 CB 1 Battery light source 11301 D 1 Adaptor for leakage test in cleaning and disinfection machines green 13242 XA 4 Cleaning adaptors for cleaning macines 11301 GG2 FF2 HH KK2 6 1 1 Pribor 1 Umetak usisnog ventila ponovno upotrebljiv 11301 CB 1 Baterijski izvor svjetlosti 11301 D 1 Adapter za ispitivanje propusnosti u strojevima za čišćenje i de...

Страница 18: ...tzter Richtung 7 3 Lippenventil montieren nur Broncho Fiberskope Das Lippenventil für Einmalgebrauch auf den Instrumentenkanal setzen mit Drehung im Uhrzeigersinn leicht anziehen Kunststoffteil 7 2 Fitting the tube holder only intubation fiberscopes Push the tube holder onto the fiberscope from dis tal and secure it by turning the two parts in opposite directions 7 3 Fitting the lip valve only bro...

Страница 19: ...uides so that no optical fibers break off It is therefore best to suspend the fiberscopes for storage or keep in large containers Do not jerk the up down control or move forcefully Do not insert the instruments or cleaning brush es forcefully through the channels This may cause damage to the casing especially if the tip of the instrument is deflected Carefully protect the objective lens at the dis...

Страница 20: ...optimum visualization of the operating field The higher the intensity setting of the light source the greater the heat energy that will be generated at the tip of the fiberscope 3 WARNING Never lay the end of the fiber optic cable or the distal tip of the fiberscope on or under a sterile cover cloth The light intensity may lead to burns on the patient and or sterile cover cloth When connecting and...

Страница 21: ...messer des Zubehörs Ungeeignetes Zubehör kann Fiberskope beschädigen Bei Fragen zum Zubehör wenden Sie sich bitte direkt an KARL STORZ oder an den autorisierten Fachhandel If no instrument is inserted close the instrument channel proximally with a plug Art no 29100 If an instrument is to be inserted position the disposable lip valve Art no 11301 CA to seal off the instrument channel proximally Ins...

Страница 22: ...cissors or other accesso ries that can be opened or closed ensure that the instrument is completely closed prior to insertion into the instrument channel Do not attempt to open the jaws until the distal tip is completely free of the channel Opening the jaws inside the instrument channel can lead to damage to the fiberscope 3 WARNING When using HF electrodes or laser probes make sure that the activ...

Страница 23: ...must be removed Once the stone is removed the stone basket may then be taken out of the instrument channel 2 CAUTION The fiberscopes must be cleaned and then reprocessed immediately after the intervention in order to prevent incrustations Dried on incrustations may jeopardize successful decontamination and disinfection 2 CAUTION Use only KARL STORZ accesories guide probes cleaning brushes etc Acce...

Страница 24: ... lens with a cotton applicator soaked in alcohol maintaining hygienic conditions at all times DCI fiberscope image quality can be controlled on screen If necessary clean image waveguides light cables and eyepieces as described above If it is still cloudy it is possible that the objective lens is scratched or that there is moisture inside the telescope The fiberscope must not be used in this case b...

Страница 25: ...smoothly and slowly Some fiberscopes have contrapositive deflection direction urology a locking mechanism for securing the fiberscope tip gynecology Modelle mit Lock Mechanismus zur Fixierung des Abwinkelzustandes des distalen Endes drehen Sie den Lock Mechanismus langsam nach distal bis ein Widerstand fühlbar ist 2 VORSICHT Weiteres Bewegen des Lock Mechanismus unter Kraftanwendung in dieselbe Ri...

Страница 26: ...hould be no instrument in the suction channel during suction The instrument channel inlet should be closed so that no secondary air is drawn in 10 4 Insufflation Under anesthesia connect the O2 hose to the instrument channel using a barbed tube Art no 600007 on the instrument channel or if you are using the three way double stopcock adapter with LUER Lock Art no 6927691 attach the hose to the tube...

Страница 27: ...cial diagnosis light D Light C Adjust the PDD filter changer for special filters designed for this light and possibly for marker substances ALA for a special tumor marker based on aminolevulinic acid W for white light AF autofluorescence mode 1 NOTE If the filter changer is set to ALA or AF a yellowish image is produced when viewing through the integrated special filter 1 NOTE No filter changer is...

Страница 28: ...g der verwendeten Kamera kontrolleinheit beschrieben 1 NOTE The entrance and exit faces of the light cable and endoscope must be kept clean if optimal light delivery is to be maintained Clean the surfaces with a cotton applicator soaked in cleaning solution then disinfect it with a cotton applicator soaked in 70 isopropyl alcohol and dry DCI fiberscopes are focused using the adjustment wheel on th...

Страница 29: ... Kopplungsmechanismus ist gelöst 12 1 Assembly Slide the DCI fiberscope into the snap in DCI coupling mechanism of the DCI eyepiece adaptor until the coupling snaps in automatically Connect a light cable or a battery powered light source 3 WARNING The instruction manuals of the supply units used must be observed 12 2 Disassembly Remove the light cable or battery powered light source Hold the DCI e...

Страница 30: ...ps anschließen 1 HINWEIS Das Spezial Lichtkabel 495 DC oder 495 DV kann nicht verwendet werden und muss ggf von der DCI Kamera entfernt werden 3 WARNUNG Die Gebrauchsanweisungen der verwendeten Versorgungsgeräte sind zu beachten 13 DCI camera on DIN eyepiece 13 1 Assembly Put the focusing ring if available of the fiberscope in the zero position mark Slide the DCI adaptor 20260030 into the snap in ...

Страница 31: ...ble endoscope for repair 3 ATTENTION The pressure compensation cap must be in place on the vent port for sterilization and transport to ensure pressure compensation 3 ATTENTION Never clean flexible endoscopes with metal brushes 3 ATTENTION Constant changing between various reprocessing methods is hard on the materials and should be avoided However a one off change of method due to procurement of n...

Страница 32: ...mind the microbiological range of action of the chemicals 1 NOTE National laws and regulations must be observed 1 NOTE We recommend using a plastic basin for disinfection to avoid damaging the endoscope Furthermore use of a plastic basin prevents electrolytic corrosion which can occur if there are different metals in a solution 1 NOTE The manual Cleaning Disinfection Care and Sterilization of KARL...

Страница 33: ...a suitable adaptor 14 2 Precleaning Remove the entire instrument set from the instrument channel Remove the suction valve set from the valve nozzle press the projections on the side together and pull out the suction valve insert Dispose of the removed single use parts Dismantle other parts if necessary and reprocess them separately Heavy soiling corrosive solutions and pharmaceuticals must be remo...

Страница 34: ... connection tube of the leakage tester and the vent port on the endoscope must be dry 1 Attach the adaptor of the leakage tester securely to the product s vent port and lock in place using the bayonet mount 2 Using the leakage tester pump air into the product until a pressure of 160 180 mmHg blue area is reached The angled rubber at the distal end can easily expand while the air is pumped into the...

Страница 35: ...FN If the air pressure does not drop the product is leakproof The leakage test Phase 2 can be performed with the product 1 NOTE To increase safety the leakage test Phase 1 can also be carried out directly after using the product 14 3 2 Phase 2 Performing the leakage test in liquid 1 Lay the product in liquid and ensure that the leakage tester is not moist 2 Fully cover the product with liquid and ...

Страница 36: ...protective film 13990 SFN If the air pressure does not drop and no bubbles emerge from the product the product is leakproof Remove the product from the liquid and then press the vent button on the pressure tester Wait until the air pressure has dropped to 0 mmHg The product can now be cleaned 14 4 Disassembly Before cleaning and disinfection remove the adaptor and other detachable parts from the l...

Страница 37: ...duct from the cleaning solution 14 If relevant irrigate the lumen with air 15 If relevant remove the adaptor 16 Dry the surface with a soft low lint cloth 17 If relevant connect the adaptor 18 Completely immerse the product in water of the best possible quality 19 If relevant fill the lumen with water using the syringe and ensure bubble free wetting 20 If relevant remove the adaptor 21 Remove the ...

Страница 38: ...ied by the manufacturer the endoscope must be rinsed several times in order to remove all chemical residues Sterile filtered water must be used for the final rinsing 14 5 4 Drying Finally the surfaces and channels lumens are dried completely with preferably sterile compressed air in accordance with the national regulations The cleaning gun with accessories Art no 27660 is ideal for this purpose 3 ...

Страница 39: ... specified by the chemical manufacturer during the cleaning process 6 Brush the surfaces of the handle at least 3 times until no residue can be seen anymore 7 The mobile parts must be brushed 8 If relevant clean the valve seats by brushing them and turning them 360 3 times until no residue can be seen anymore 9 Clean the surface of the sheath with a low lint cloth until no residue can be seen anym...

Страница 40: ...ing and disinfection the endoscope s working and suction channel must be connected to the washer and disinfector using the recommended adaptors 2 CAUTION The pressure compensation cap must not be in place on the vent port for cleaning and disinfection 14 6 3 Machine cleaning chemical thermal disinfection A maximum temperature of 60 C and a maximum pressure of 100 kPa 1 bar 14 5 psi must not be exc...

Страница 41: ...movement Damaged or corroded medical devices must be withdrawn from use 1 NOTE Inspect plastic parts for discoloration porosity and flexibility If the parts have changed substantially from their original condition they must be replaced This especially applies to seals and rubber caps If there is still residual moisture on or in the endoscope it must be dried again manually The surfaces e g connect...

Страница 42: ... deposits on the optical surfaces it should certainly not be used routinely during reprocessing Stubborn soiling and deposits can be removed with cleaning paste Art no 27661 For this purpose some cleaning paste is put on a clean damp cleaning bud and distributed on the glass surfaces Polishing ensures that even stubborn deposits are removed 1 NOTE The instrument must be reprocessed again following...

Страница 43: ...ort to ensure pressure compensation 1 NOTE All deviations from the recommended sterilization parameters must be validated by the user 1 NOTE When using reprocessing devices please observe the device manufacturers instructions 1 NOTE Sterilization is not possible on surfaces which have been lubricated and oiled The procedures as well as the process relevant parameters for the individually validated...

Страница 44: ...AD sterilization processes have been validated and approved by KARL STORZ for this medical device STERRAD 100S Long Cycle with without booster STERRAD NX Advanced Cycle STERRAD 100NX Flex Cycle STERRAD 100NX DUO Cycle 14 9 2 Hydrogen peroxide H2O2 sterilization STERIS V PRO 1 NOTE The STERIS Low Temperature Reprocessing Device Compatibility Matrix can be used to verify whether the medical device c...

Страница 45: ...in 180 min Ventilation Time 12 hrs 24 hrs 12 hrs Temperature 55 C 131 F Konditionierung Temperatur 55 C 131 F Feuchtigkeit 70 Haltezeit 30 min Sterilisation Temperatur 55 C 131 F Feuchtigkeit 70 Haltezeit 30 45 min EO Konzentration 725 30 mg L 735 30 mg L EO Einwirkzeit 60 min 120 min 180 min Belüftung Zeit 12 h 24 h 12 h Temperatur 55 C 131 F 14 9 3 Sterilizacija etilen oksidom EO Postupak s etil...

Страница 46: ...t functioning are largely determined by mechanical stress and chemical influences within the scope of reprocessing and application 14 11 Storage The storage method must be selected taking into account the respective applicable national requirements KARL STORZ only recommends dust protected suspended storage for decontaminated endoscopes Horizontal storage is possible for sterilized endoscopes KARL...

Страница 47: ...ereitung müssen diesen entnommen werden 14 12 Reprocessing of accessories Extensive accompanying documentation is available for the accessories It is essential that you refer to these documents for further information on handling and reprocessing 14 12 Obrada pribor Za pribor postoji proširena proizvodna dokumentacija Dodatne informacije o rukovanju i obradu moraju se potražiti ondje ...

Страница 48: ...50 3 2 4 2 mm 230 cm 110961 50 3 2 4 2 mm 190 cm 110960 50 3 2 4 2 mm 140 cm 110952 50 2 6 3 0 mm 250 cm 110951 50 2 6 3 0 mm 165 cm 110950 50 2 6 3 0 mm 120 cm 110942 50 2 0 2 3 mm 160 cm 110941 50 2 0 2 3 mm 120 cm 110940 50 2 0 2 3 mm 90 cm 110932 50 1 2 1 5 mm 210 cm 110931 50 1 2 1 5 mm 135 cm 110930 50 1 2 1 5 mm 100 cm 14 13 Pregled četke za čišćenje Br artikla Promjer radnog kanala Duljina...

Страница 49: ...ance of this instrument subject to the following conditions assembly system expansion readjustment modification or repair have been performed by persons authorized by KARL STORZ and that the instrument is used in accordance with the instruction manual 15 3 Warranty The warranties provided can be found in the Standard Conditions of Business of KARL STORZ The medical device must always be sent to yo...

Страница 50: ...h is normally adequate to ensure prompt replacement of damaged telescopes and instruments Under the repair and replacement plan you receive an identical as new device and are only charged the repair costs for the defective device For telescopes you receive a warranty of 1 year for instruments 1 2 year For fiberscopes and devices individual repair is necessary To bridge the repair period you will r...

Страница 51: ...edical devices All medical devices must be decontaminated on site to avoid contact and aerogenous infections among personnel We reserve the right to return contaminated instruments devices to the sender Repairs modifications or expansions which are not performed by KARL STORZ or by experts authorized by KARL STORZ will invalidate all warranty rights KARL STORZ gives no warranty on the correct func...

Страница 52: ......

Страница 53: ......

Страница 54: ...venue 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 STORZ SE Co KG Representation Office Sabit Orudschow 1184 apt 23 1025 Baku Azerbaijan Phone 99 450 613 30 60 E Mail info az karlstorz com KARL STORZ ENDOSKOPE East Mediterranean and Gulf Offshore S A L Spark Tower 1st floor Charles Helou St ...

Страница 55: ......

Страница 56: ...KARL STORZ SE Co KG Dr Karl Storz Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon 49 7461 708 0 Telefax 49 7461 708 105 E Mail info karlstorz com Web www karlstorz com ...

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