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96286011D

Niederlassungen

Subsidiaries

Sociedades distribuidoras

13  Niederlassungen

13  Subsidiaries

KARL STORZ Endoskop Sverige AB 

Storsätragränd 14 

127 39 Skärholmen, Sweden 

Phone: +46 8 505 648  00 

E-Mail: [email protected]
KARL STORZ Endoscopy Suomi OY 

Taivaltie 5 

01610 Vantaa, Finland 

Phone: +358 (0)96824774, Fax: +358 (0)968247755 

E-Mail: [email protected]
KARL STORZ SE & Co. KG 

Representation Office 

Kęstučio st. 59 / Lenktoji st. 27  

08124 Vilnius, Lithuania 

Phone: +370 5 272 0448 

Mobile: +370 685 67 000 

E-Mail: [email protected]
KARL STORZ Endoskopi Danmark A/S 

Skovlytoften 33 

2840 Holte, Denmark 

Phone: +45 45162600, Fax: +45 45162609 

E-Mail: [email protected]
KARL STORZ Endoscopy (UK) Ltd. 

415 Perth Avenue, Slough 

Berkshire, SL1 4TQ, United Kingdom 

Phone: +44 1753 503500, Fax: +44 1753 578124 

E-Mail: [email protected]
KARL STORZ Endoscopie Nederland B. V. 

Displayweg 2 

3821 BT Amersfoort, Netherlands 

Phone: +31 (0)33 4545890 

E-Mail: [email protected]
KARL STORZ Endoscopy Belgium N. V. 

Phone: +31 (0)33 4545890 

E-Mail: [email protected]
KARL STORZ Endoscopie France S. A. S. 

12, rue Georges Guynemer, Quartier de l’Europe 

78280 Guyancourt, France 

Phone: +33 1 30484200, Fax: +33 1 30484201  

E-Mail: [email protected]
KARL STORZ Endoskop Austria GmbH 

Landstraßer Hauptstr. 148/1/G1 

1030 Wien, Austria 

Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479  

E-Mail: [email protected]
KARL STORZ Endoscopia Ibérica S. A. 

Parque Empresarial San Fernando 

Edificio Munich – Planta Baja 

28830 Madrid, Spain 

Phone: +34 91 6771051, Fax: +34 91 6772981 

E-Mail: [email protected] 
KARL STORZ Endoscopia Italia S. r. l. 

Via dell’Artigianato, 3 

37135 Verona, Italy 

Phone: +39 045 8222000, Fax: +39 045 8222001 

E-Mail: [email protected]
KARL STORZ Croatia d.o.o. 

Capraška 6 

10000 Zagreb, Croatia 

Phone: +385 1 6406 070, Fax: +385 1 6406 077  

E-Mail: [email protected]

KARL STORZ SE & Co. KG 

Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany 

Postfach 230, 78503 Tuttlingen/Germany 

Phone: +49 7461 708-0, Fax: +49 7461 708-105 

E-Mail: [email protected]
KARL STORZ Endoskope Berlin GmbH 

Scharnhorststr. 3 

10115 Berlin/Germany 

Phone: +49 30 30 69090, Fax: +49 30 30 19452
KARL STORZ Endoscopy Canada Ltd. 

7171 Millcreek Drive, Mississauga, Ontario 

L5N 3R3 Canada 

Phone: +1 905 816-4500, Fax: +1 905 816-4599  

Toll free phone: 1-800-268-4880 (Canada only) 

Toll free fax: 1-800-482-4198 (Canada only) 

E-Mail: [email protected]
KARL STORZ Endoscopy-America, Inc. 

2151 East Grand Avenue 

El Segundo, CA 90245-5017, USA  

Phone: +1 424 218-8100, Fax: +1 424 218-8525 

Toll free phone: 800 421-0837 (USA only) 

Toll free fax: 800 321-1304 (USA only) 

E-Mail: [email protected]
KARL STORZ Veterinary Endoscopy-America, Inc. 

1 South Los Carneros Road 

Goleta, CA 93117, USA 

Phone: +1 805 968-7776, Fax: +1 805 685-2588 

E-Mail: [email protected]
KARL STORZ Endoscopia Latino-America, Inc. 

815 N. W. 57th Avenue, Suite 480 

Miami, FL 33126-2042, USA 

Phone: +1 305 262-8980, Fax: +1 305 262-8986  

E-Mail: [email protected]
KARL STORZ Endoscopia México S.A. de C.V.  

Edificio Atlantic, Oficina 3G 

Calle D e/ 1ra y 3ra 

10400 Vedado, Havanna, Cuba 

Phone: +537 836 95 06, Fax: +537 836 97 76 

E-Mail: [email protected]
KARL STORZ Endoscopia México S.A. de C.V.  

Av. Ejercito Nacional No. 453 Piso 2,  

Colonia Granada, Alcaldia Miguel Hidalgo  

C.P. 11520 Ciudad de México  

Phone: +52 (55) 1101 1520  

E-Mail: [email protected]
KARL STORZ Marketing América Do Sul Ltda. 

Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi,  

CEP-04534-011 São Paulo, Brasil 

Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 

E-Mail: [email protected] 
KARL STORZ Endoscopia Argentina S.A. 

Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez  

Provincia de Buenos Aires, Argentina 

Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 

E-Mail: [email protected]
KARL STORZ Endoskopi Norge AS 

Stamveien1 

1483 Hagan, Norway 

Phone: +47 6380 5600, Fax: +47 6380 5601 

E-Mail: [email protected]

KARL STORZ Endoskopija d.o.o. 

Cesta v Gorice 34b 

1000 Ljubljana, Slovenia 

Phone: +386 1 620 5880, Fax: + 386 1 620 5882 

E-Mail: [email protected]
KARL STORZ Polska Sp. z o.o. 

ul. Bojkowska 47 

44-100 Gliwice, Poland 

Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 

E-Mail: [email protected]
KARL STORZ Endoszkóp Magyarország Kft. 

Toberek utca 2. fsz. 17/b 

HU-1112 Budapest, Hungary 

Phone: +36 195 096 31, Fax: +36 195 096 31 

E-Mail: [email protected]
KARL STORZ Endoscopia Romania srl 

Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4 

041393 Bukarest, Romania 

Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801  

E-Mail: [email protected] 
KARL STORZ Endoskope Greece M.E.P.E.* 

Patriarhou Grigoriou E’ 34 

54248 Thessaloniki, Greece 

Phone: +30 2310 304868, Fax: +30 2310 304862 

E-Mail: [email protected]

*Repair & Service Subsidiary

KARL STORZ Industrial** 

Gedik Is Merkezi B Blok 

Kat 5, D 38-39, Bagdat Cad. No: 162 

Maltepe Istanbul, Turkey 

Phone: +90 216 442 9500, Fax: +90 216 442 9030

**Sales for Industrial Endoscopy 

OOO KARL STORZ Endoskopy – WOSTOK 

Derbenyevskaya nab. 7, building 4 

115114 Moscow, Russia 

Phone: +7 495 983 02 40, Fax: +7 495 983 02 41 

E-Mail: [email protected]
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: [email protected]
KARL STORZ SE & Co. KG 

Representation Office 

Sabit Orudschow 1184, apt. 23 

1025 Baku, Azerbaijan 

Phone: +99 450 613 30 60 

E-Mail: [email protected]
KARL STORZ ENDOSKOPE – 

East Mediterranean and Gulf (Offshore) S.A.L. 

Spark Tower 1

st

 floor 

Charles Helou St., Horch Tabet – Sin El Fil 

Beirut, Lebanon 

Phone: +961 1 501105, Fax: +961 1 501950 

E-Mail: [email protected]
KARL STORZ Endoscopy (South Africa) (Pty) Ltd. 

P.O. 6061, Roggebaai 8012 

Cape Town, South Africa 

Phone: +27 21 417 2600, Fax: +27 21 421 5103 

E-Mail: [email protected]

TOO KARL STORZ Endoskopy Kasachstan 

Saryarka, 6, BC “Arman”, off. 910 

010000  Astana, Republic of Kazakhstan 

Phone: +7 7172 552-549, 552-788, Fax: -444  

E-Mail: [email protected]
KARL STORZ ENDOSKOPE  

East Mediterranean & Gulf (branch) 

Building West Side 7A – Unit 7WA – 3008 

Dubai Airport Free Zone, P.O. Box 54983 

Dubai - United Arab Emirates 

Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282 

Service Hotline: +971 (0)4 3415882 

E-Mail: [email protected]
KARL STORZ Endoscopy India Private Limited 

11

th

 Floor, Dr. Gopal Das Bhawan 

28, Barakhamba Road 

New Delhi 110001, India 

Phone: +91 11 4374 3000, Fax: +91 11 4374 3010 

E-Mail: [email protected]
KARL STORZ SE & Co. KG 

Interchange 21 Tower, Level 33 

399 Sukhumvit Road, 

North Klongtoey, Wattana,  

10110 Bangkok, Thailand 

Phone: +66 2 660 3669 

E-Mail: [email protected]
KARL STORZ SE & Co. KG 

Resident Representative Office 

14

th

 Floor, MPlaza Saigon 

39 Le Duan, District 1 

Ho Chi Minh City, Vietnam 

Phone: +84 28 3823 8000, Fax: +84 28 3823 8039 

E-Mail: [email protected]
KARL STORZ Endoscopy China Ltd. 

Room 2503-05, 25F AXA Tower, Landmark East, 

No. 100 How Ming Street, Kwun Tong, Kowloon,  

Hong Kong, People’s Republic of China 

Phone: +852 28 65 2411, Fax: +852 28 65 4114 

E-Mail: [email protected]
KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch  

Room 1805-1807, Building B, 18F Beijing IFC 

No. 8, Jianguomenwai Street, Chaoyang District, 

100022, Beijing, People’s Republic of China 

Phone: +86 10 5638188, Fax: +86 10 5638199 

E-Mail: [email protected]
KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai Branch 

Room 701A Building 5 & Room 501 Building 7, 

No. 3000 Longdong Avenue, Pilot Free Trade Zone, 

201203, Shanghai, People’s Republic of China 

Phone: +86 21 60339888, Fax: +86 21 60339808  

E-Mail: [email protected]
KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch 

Room 803-805, 8F Jin Jiang International Building 

No. 1 West Linjiang Road, Wuhou District, 

6100414, Chengdu, People’s Republic of China 

Phone: +86 28 86587977, Fax: +86 28 86587975 

E-Mail: [email protected]
KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch 

Room 2001-2005, 20F N-MEDIA International Center,  

No. 167 Youth Avenue, Shenhe District, 

110014, Shenyang, People‘s Republic of China 

Phone: +86 24 23181118, Fax: +86 24 23181119 

E-Mail: [email protected] 

KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch 

Room 02B & 03 & 04A, 35F Teem Tower,  

No. 208 Tianhe Road, Tianhe District, 

510620, Guangzhou, People’s Republic of China 

Phone: +86 20 87321281, Fax: +86 20 87321286 

E-Mail: [email protected]
KARL STORZ Endoscopy Asia Marketing Pte Ltd. 

No. 8 Commonwealth Lane #03-02 

Singapore 149555, Singapore 

Phone: +65 69229150, Fax: +65 69229155 

E-Mail: [email protected]
KARL STORZ Endoscopy Singapore Sales Pte Ltd 

No. 8 Commonwealth Lane #03-02 

Singapore 149555, Singapore 

Phone: +65 69229150, Fax: +65 69229155 

E-Mail: [email protected]
KARL STORZ SE & Co. KG 

Representative Office Indonesia 

Sinarmas MSIG Tower Level 37 

Jl. Jend. Sudirman No. Kav. 21 

Jakarta Selatan 

DKI Jakarta 12920 

E-Mail: [email protected]
KARL STORZ Endoscopy Korea Co. Ltd. 

9F Hyowon-Building 

97, Jungdae-ro, Songpa-gu 

05719 Seoul, Korea 

Phone: +82-70-4350-7474, Fax: +82-70-8277-3299 

E-Mail: [email protected]
KARL STORZ Endoscopy Taiwan Ltd. 

12F, No. 192, Sec. 2, Chung Hsin Rd.,  

Sindian District, New Taipei City, Taiwan 

Phone: +886 933 014 160, Fax: +886 2 8672 6399 

E-Mail: [email protected]
KARL STORZ SE & Co. KG 

Representative Office Philippines 

1901 Picadilly Star Bldg., 4

th

 Avenue, BGC 

Taguig City 1636, Philippines 

Phone: +63 2 317 45 00, Fax: +63 2 317 45 11 

E-Mail: [email protected]
KARL STORZ Endoscopy Japan K. K. 

Stage Bldg. 8F, 2-7-2 Fujimi 

Chiyoda-ku, Tokyo 102-0071, Japan  

Phone: +81 3 6380-8622, Fax: +81 3 6380-8633 

E-Mail: [email protected]
KARL STORZ Endoscopy New Zealand Ltd. 

31 Morningside Drive Mt Albert  

Auckland, 1025, New Zealand 

PO Box 56 511, Dominion Rd 

Auckland, 1446, New Zealand  

Phone: +64 9 846 6044, Fax: +64 9 846 6808 

Toll free: +64 508 84 84 84 (New Zealand only) 

E-Mail: [email protected] 
KARL STORZ Endoscopy Australia Pty. Ltd . 

68 Waterloo Road, Macquarie Park NSW 2113  

P O Box 50 Lane Cove NSW 1595, Australia 

Phone: +61 (0)2 9490 6700 

Toll free: 1800 996 562 (Australia only) 

Fax: +61 (0)2 9420 0695 

E-Mail: [email protected]
www.karlstorz.com

SL09 20

13  Sociedades distribuidoras

Содержание Image1 S H3-Z FI TH 102

Страница 1: ...NWEISUNG IMAGE1 S 4U Rubina OPAL1 NIR ICG Kamerakopf TH121 INSTRUCTION MANUAL IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head TH121 MANUAL DE INSTRUCCIONES Cabezal de la cámara IMAGE1 S 4U Rubina OPAL1 NIR ICG TH121 ...

Страница 2: ...ils and all actions on your part are clearly presented and explained Please read this instruction manual carefully before proceeding with the equipment Keep this instruction manual available for ready reference in a convenient location near the equipment 96286011 D Version 2 0 09 2020 Es wird empfohlen vor der Verwendung die Eignung der Produkte für den geplanten Eingriff zu überprüfen It is recom...

Страница 3: ...g the focus 10 6 Technical description 11 6 1 Specifications 11 6 2 Storage and Operating conditions 11 6 3 Standard compliance 11 6 4 Directive compliance 11 7 Reprocessing not validated for US customers 12 7 1 Care and handling 12 7 2 Reprocessing 13 7 2 1 Reference chart 13 7 2 2 General warnings 14 7 2 3 Accessories 15 7 2 4 Manual wipe down disinfection 15 7 2 5 Preparation for cleaning and d...

Страница 4: ...rilization 24 8 2 9 High level disinfection 27 8 2 10 Reprocessing limits 27 9 Maintenance 28 9 1 Maintenance 28 9 2 Servicing and repair 28 9 3 Disposal 28 9 4 Repairing devices 29 9 5 Infection prevention 29 9 6 Limitation of liability 30 9 7 Warranty 30 10 Compatible camera control unit CCU 31 11 Spare parts recommended accessories 32 12 Information on electromagnetic compatibility EMC 33 13 Su...

Страница 5: ...re the safe and effective operation of the system To make these words stand out more clearly they are accompanied by a pictogram 3 3 WARNING A Warning indicates that the personal safety of the patient or physician is at risk 2 2 CAUTION A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the device 1 1 NOTE A Note indicates special inf...

Страница 6: ...taken to avert contact between the HF surgical device and the endoscope or endoscopic camera Inadvertent contact may represent a thermal hazard to the surgeon 3 3 WARNING When energized endoscopes are used with energized endotherapy devices patient leakage currents may be additive It should be noted that this is particularly important if a Type CF applied part endoscope is used in which case a Typ...

Страница 7: ...uring surgery the camera may be disengaged from the endoscope and the procedure continued optically If this is not possible it is up to the discretion of the surgeon how best to proceed Availability of a spare system is recommended 3 3 WARNING High energy radiated light through endoscopes may give rise to high temperatures in front of the light outlet and to the tip of the endoscope To minimize th...

Страница 8: ... no direct contact with the patient 2 1 Contraindications No contraindications relating directly to the medical device are currently known The responsible physician must decide whether the foreseen application is admissible based on the general condition of the patient 2 2 User qualification The IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head may only be used by physicians and medical assistants who ...

Страница 9: ... for scrolling downwards through the menu or activating a camera function 4 User control button for scrolling upwards through the menu or activating a camera function 5 User control button for accessing the menu making a selection Images of the equipment Imágenes del equipo 4 5 2 1 3 3 Imágenes del equipo 1 Acoplamiento para instrumentos 2 Anillo rueda de enfoque 3 Botón de control desplazamiento ...

Страница 10: ...0 C 140 F 14 F Temperature limit Serial number Number of products in the product packaging CE marking top Consult instructions for use Manufacturer Rx only Federal USA law restricts this device to sale by or on the order of a physician Symbols employed Explicación de los símbolos Frágil manipular con cuidado Manténgase seco 10 C 60 C 140 F 14 F Límite de temperatura Número de serie Cantidad de pro...

Страница 11: ...the IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head 5 2 1 Connecting an endoscope and light cable The IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head has an integrated instrument coupler and integrated telescope To connect an endoscope to the instrument coupler turn the outer ring of the coupler clockwise and insert the endoscope eyepiece To prevent rotation of the endoscope the outer ring of the instru...

Страница 12: ...rimental effect on the light conduction and thus the image quality 1 1 NOTE For further information regarding light cables please refer to the manual Fiberoptic light cables 97000213 which can be downloaded or requested at www karlstorz com 5 2 2 Adjusting the focus The focus on the IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head can be adjusted by turning the focusing ring knob 2 on the camera lens ...

Страница 13: ...Standard compliance According to IEC 60601 1 EC 60601 2 18 Provides Type CF protection when used with KARL STORZ Camera Control Units that have CF symbol on connection port 6 4 Directive compliance According to the Medical Device Directive MDD This medical device belongs to Class I This medical device bears a CE mark in accordance with MDD 93 42 EEC Technische Beschreibung Technical description De...

Страница 14: ...pick up and support the cable and connector The cable contains many tiny conductors and must therefore be handled with care DO NOT STORE THE CAMERA SYSTEM in direct sunlight or at high temperatures ENSURE THAT THE CABLE IS NOT COILED TOO TIGHTLY OR FOLDED UP WHILE THE CAMERA IS IN STORAGE Always arrange the cable in loose coils with a diameter of 6 inches 15 cm or more DO NOT PULL FORCEFULLY ON TH...

Страница 15: ...trasonic treatment Tratamiento con ultrasonidos Manuelle Reinigung Manual cleaning Limpieza manual Manuelle Desinfektion Manual disinfection Desinfección manual Chemische Desinfektion Chemothermal disinfection Desinfección química Thermische Desinfektion Thermal disinfection Desinfección térmica Konnektierung Connection Conexión Dampfsterilisation Steam serilization Esterilización por vapor STERRA...

Страница 16: ...edical devices the guidelines of the Employers Liability Insurance Association and equivalent organizations striving to ensure personal safety must be observed 2 2 CAUTION When preparing and using the solutions follow the chemical manufacturer s specifications paying close attention to proper concentration exposure time and service life Prolonged immersion and incorrect concentration may result in...

Страница 17: ...h a dry low lint cloth 7 2 5 Preparation for cleaning and disinfection Heavy soiling corrosive solutions and pharmaceuticals must be removed from the medical device immediately after use To this end preclean the medical device by wiping down and rinsing for example As a general rule KARL STORZ recommends manual precleaning under cold running water 7 2 6 Manual cleaning The medical device must be c...

Страница 18: ...d disinfected medical device must be visually inspected for cleanliness complete ness damage and dryness If residues or contamination are still present the medical device must be manually cleaned and subjected to a full cleaning and disinfection pro cedure once more Damaged or corroded medical devices must be withdrawn from use Afterwards a functional check must be carried out 1 1 NOTE During care...

Страница 19: ...struments which can be sterilized in the different STERRAD sterilization systems in respect of lumen dimensions and material 2 2 CAUTION For detailed information please consult the user handbook of the respective device 1 1 NOTE Refer to the STERRAD Sterility Guide to ensure that the medical device concerned can be sterilized using the different STERRAD devices 1 1 NOTE Sterilization is not possib...

Страница 20: ...on is not possible on surfaces which have been lubricated and oiled 7 2 11 Reprocessing limits The end of the product s service life is largely determined by wear reprocessing methods the chemicals used and any damage resulting from use Aufbereitung nicht validiert für US amerikanische Kunden Reprocessing not validated for US customers Preparación no validada para clientes de los EE UU Esterilizac...

Страница 21: ...en pick up and support the cable and connector The cable contains many tiny conductors and must therefore be handled with care DO NOT STORE THE CAMERA SYSTEM in direct sunlight or at high temperatures ENSURE THAT THE CABLE IS NOT COILED TOO TIGHTLY OR FOLDED UP WHILE THE CAMERA IS IN STORAGE Always arrange the cable in loose coils with a diameter of 6 inches 15 cm or more DO NOT PULL FORCEFULLY ON...

Страница 22: ...ll manual manual maschinell machine mecánica STERRAD High Level Desinfektion High Level disinfection Desinfección de alto nivel Demontage disassembly Desmontaje Manuelle Wischdesinfektion Manual wipe disinfection Desinfección por frotado manual Einlegen in Kaltwasser Submerging in cold water Inmersión en agua fría Bürsten Oberflächen Brushing of surfaces Cepillado de las superficies Bürsten Lumen ...

Страница 23: ...G When carrying out any work on contaminated medical devices the guidelines of the Employers Liability Insurance Association and equivalent organizations striving to ensure personal safety must be observed 2 2 CAUTION When preparing and using the solutions follow the chemical manufacturer s specifications paying close attention to proper concentration exposure time and service life Prolonged immer...

Страница 24: ... submerge the camera head Dilute the solution to proper concentration per manufacturer s instructions 2 Under running cold tap water Rinse the camera head to remove all gross debris paying close attention to the seam beneath the focus ring for 2 minutes Brush all camera head surfaces using the soft bristle brush P N 27652 paying close attention to the seam beneath the focus ring Brush for 2 minute...

Страница 25: ...mechanism 1 1 NOTE If heavy debris collects on the brush while brushing rinse the brush until there is no visible debris on the brush 6 While immersed use a soft lint free cloth to wipe the entire camera head cable 7 Remove the camera head from the cleaning solution 8 Under running cold tap water rinse the entire camera head and cable for 3 minutes including Focus ring Camera head buttons Cam Lock...

Страница 26: ...pproved by KARL STORZ for this medical device Hydrogen peroxide H2O2 sterilization ASP STERRAD 3 3 WARNING Medical devices must be sterilized in dismantled condition 3 3 WARNING Remember that there are restrictions concerning the instruments which can be sterilized in the different STERRAD sterilization systems in respect of lumen dimensions and material 2 2 CAUTION For detailed information please...

Страница 27: ...ethods have been validated and approved by KARL STORZ for this medical device V PRO 1 Lumen Cycle V PRO 1 Plus Lumen and Non lumen Cycle V PRO maX Lumen and Non lumen Cycle 1 Place the camera head in an FDA cleared V PRO compatible instrument tray 2 Wrap the sterilization tray with two single layers of FDA cleared polypropylene sterilization wrap using a sequential double wrapping technique If usi...

Страница 28: ...ftungsparameter Zeit mindestens 12 Stunden Temperatur 55 C 131 F Chemische Niedertemperatur Sterilisation mit Peressigsäure STERIS System 1E 1 Legen Sie den Kamerakopf in einen der folgenden Behälter C1200E SS1E General Processing Tray Container C1220E SS1E Directed Flow Processing Tray Container C1140E SS1E Flexible Endoscope Processing Tray Container C1160E SS1E Universal Flexible Processing Ope...

Страница 29: ... Wasser ist sehr wichtig um sämtliche Desinfektionsmittelrückstände zu entfernen Den Kamerakopf und den Kartenstecker mit einem flusenarmen sterilen Tuch abtrocknen Der Kartenstecker muss absolut sauber und trocken sein bevor er an den Kameraprozessor angeschlossen wird Behandeln Sie den Kamerakopfstecker mit Isopropylalkohol um even tuelle Desinfektionsmittelrückstände zu entfernen 8 2 10 Begrenz...

Страница 30: ...t öffnen Das Öffnen der versiegelten Einheiten kann die Dichtigkeit beeinträchtigen und macht alle Garantien nichtig Die Abdeckungen am Kameraprozessor dürfen nur von befugten Personen entfernt werden 9 3 Entsorgung Dieses Gerät ist entsprechend der europäischen Richtlinie über Elektro und Elektronik Altgeräte waste electrical and electronic equipment WEEE gekennzeichnet Nach Ablauf der Lebensdaue...

Страница 31: ...park 83 78579 Neuhausen Service hotline 49 7461 708 980 E mail technicalsupport karlstorz com In other countries the respective KARL STORZ branches or specialist dealers are responsible 9 5 Infection prevention Contaminated devices may not be shipped To prevent contact infections and airborne infections devices must first be decontaminated KARL STORZ reserves the right to send back contaminated de...

Страница 32: ...in accordance with its operating instructions at all times 9 7 Warranty The guarantees provided can be found in the Standard Conditions of Business of KARL STORZ The medical device must always be sent to your local subsidiary see Subsidiaries section even during the warranty period Opening the equipment or performance of any repairs or modifications to the equipment by unauthorized persons shall r...

Страница 33: ...l units are available with various configurations and image outputs These camera control units are compatible with IMAGE1 S camera heads Please check your local region for device configuration availability Kompatible Kamera Kontrolleinheit Compatible camera control unit CCU Unidad de control de la cámara compatible 10 Unidad de control de la cámara compatible Artículo N º de artículo IMAGE1 S 4U L...

Страница 34: ...ough the telescope and on the monitor 9530BD Dust cap for camera heads 6349190 Sterile drapes for KARL STORZ cameras Instruction Manual 96286011D Instruction manual IMAGE1 S 96206286D For safe and comfortable use of KARL STORZ cameras we recommend the use of sterile drapes Ersatzteile empfohlenes Zubehör Spare parts recommended accessories Piezas de repuesto accesorios recomendados 11 Piezas de re...

Страница 35: ...n 30 cm 12 inches to any part of the IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result 1 1 NOTE The emission characteristics of this equipment make it suitable for use in indus trial areas as well as in hospitals CISPR 11 Class A and other professional healthcare environment If it is u...

Страница 36: ...für 25 30 Perioden bei 0 Phasenwinkel Abfall auf 0 für 1 2 Periode bei 0 45 90 135 180 225 270 und 315 Phasenwinkeln Spannungsunterbrechung 100 für 250 300 Perioden Spannungseinbruch Einbruch auf 0 für 1 Periode bei 0 Phasenwinkel Einbruch auf 70 für 25 30 Perioden bei 0 Phasenwinkel Abfall auf 0 für 1 2 Periode bei 0 45 90 135 180 225 270 und 315 Phasenwinkeln Spannungsunterbrechung 100 für 250 3...

Страница 37: ...e acc to IEC 61000 4 11 Voltage Dip Dip to 0 for 1 cycle 0 phase angle Dip to 70 for 25 30 cycles 0 phase angle Dropout to 0 for 0 5 cycle 0 45 90 135 180 225 270 315 phase angles Voltage interruption 100 for 250 300 cycles Voltage Dip Dip to 0 for 1 cycle 0 phase angle Dip to 70 for 25 30 cycles 0 phase angle Dropout to 0 for 0 5 cycle 0 45 90 135 180 225 270 315 phase angles Voltage interruption...

Страница 38: ... 4 11 Caída de tensión Caída a 0 para 1 ciclo con un ángulo de fase de 0 Caída a 70 para 25 30 ciclos con un ángulo de fase de 0 Fallo a 0 para 1 2 ciclo con ángulos de fase de 0 45 90 135 180 225 270 y 315 Interrupción de tensión 100 para 250 300 ciclos Caída de tensión Caída a 0 para 1 ciclo con un ángulo de fase de 0 Caída a 70 para 25 30 ciclos con un ángulo de fase de 0 Fallo a 0 para 1 2 cic...

Страница 39: ...Pulsmodulation 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulsmodulation 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulsmodulation 217 Hz 28 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulsmodulation 217 Hz 28 28 5240 5100 5800 WLAN 802 11 a n Pulsmodulation 217 Hz 9 9 5500 5785 ...

Страница 40: ...0 TETRA 400 Pulse modulation 18 Hz 27 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz Sine Wave 28 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 28 28 1845 1970 2450 2400 2570 ...

Страница 41: ... 385 380 390 TETRA 400 Modulación por impulsos 18 Hz 27 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz desviación 1 kHz onda senoidal 28 28 710 704 787 Banda LTE 13 y 17 Modulación por impulsos 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Banda LTE 5 Modulación por impulsos 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Banda LTE 1 3 4 25 UMTS Modulación po...

Страница 42: ...ntersuchung vor Orta geringer als der Übereinstimmungspegel sein b Gestrahlte HF Störgrößen nach IEC 61000 4 3 3 V m 80 MHz bis 2 5 GHz 3 V m d 80 MHz bis 800 MHz e 800 MHz bis 2 5 GHz In der Umgebung von Geräten die das folgende Bildzeichen tragen sind Störungen möglich 7 Anmerkung Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich Anmerkung Diese Leitlinien mögen nicht in allen Situationen z...

Страница 43: ...from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Radiated RF disturbances acc to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m f 80 MHz to 800 MHz h 800 MHz to 2 5 GHz Interference may occur in the vicinity of equipment marked with the following symbol 7 Note At 80 MHz and 800 MHz the higher frequency range ...

Страница 44: ... RF según se determina por un estudio electromagnético del lugar a debería ser menor que el nivel de conformidad en cada rango de frecuencia b Perturbaciones de RF radiada según la norma CEI 61000 4 3 3 V m 80 MHz a 2 5 GHz 3 V m d 80 MHz a 800 MHz e 800 MHz a 2 5 GHz La interferencia puede producirse en la vecindad del equipo marcado con el siguiente símbolo 7 Nota A 80 MHz y 800 MHz se aplica el...

Страница 45: ...ndet wird HF Aussendungen nach CISPR 11 Gruppe 1 Der IMAGE1 S 4U Rubina OPAL1 NIR ICG Kamerakopf verwendet HF Energie ausschließlich für die interne Funktion Daher ist die HF Aussendung sehr gering und es ist unwahrscheinlich dass benachbarte elektronische Geräte gestört werden HF Aussendungen nach CISPR 11 Klasse A Der IMAGE1 S 4U Rubina OPAL1 NIR ICG Kamerakopf ist für den Gebrauch in anderen Ei...

Страница 46: ...at it is used in such an environment RF emissions as per CISPR 11 Group 1 The IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipment RF Emissions as per CISPR 11 Class A The IMAGE1 S 4U Rubina OPAL1 NIR ICG camera head is suitable for use in all establ...

Страница 47: ...egún la norma CISPR 11 Grupo 1 El cabezal de la cámara IMAGE1 S 4U Rubina OPAL1 NIR ICG usa energía de RF exclusivamente para su función interna Por ello sus emisiones de RF son muy bajas y no es probable que causen interferencias en los equipos electrónicos en las proximidades Emisiones de RF según la norma CISPR 11 Clase A El cabezal de la cámara IMAGE1 S 4U Rubina OPAL1 NIR ICG es adecuado para...

Страница 48: ...ie unten angegeben einhält Nennleistung des Senders W Schutzabstand d m abhängig von der Sendefrequenz 150 kHz bis 80 MHz d 80 MHz bis 800 MHz d 800 MHz bis 2 5 GHz e 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Für Sender deren maximale Nennleistung in obiger Tabelle nicht angegeben ist kann der empfohlene Schutzabstand d in Metern m unter Verwendung der Gleich...

Страница 49: ...quipment Rated maximum output power of transmitter W Separation distance d m as a function of the transmitter frequency 150 kHz to 80 MHz f 80 MHz to 800 MHz f 800 MHz to 2 5 GHz h 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance D in meters m can be estimated using...

Страница 50: ...quipo de comunicaciones Máxima potencia de salida asignada al transmisor W Distancia de separación d m conforme a la frecuencia del transmisor 150 kHz a 80 MHz d 80 MHz a 800 MHz d 800 MHz a 2 5 GHz e 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Para los transmisores cuya potencia máxima de salida no está listada arriba la distancia de separación recomendada d e...

Страница 51: ...nyevskaya nab 7 building 4 115114 Moscow Russia Phone 7 495 983 02 40 Fax 7 495 983 02 41 E Mail Info ru karlstorz 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 STORZ SE Co KG Representation Office Sabit Orudschow 1184 apt 23 1025 Baku Azerbaijan Phone 99...

Страница 52: ...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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