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Hinweise zur
elektromagnetischen
Verträglichkeit (EMV)

Indicaciones sobre
compatibilidad
electromagnética (CEM)

Information on
electromagnetic

compatibility (EMC)

Tabla 4 – Clase y grupo de emisiones

Guía y declaración del fabricante – Emisiones electromagnéticas

El cabezal de la cámara IMAGE1 S™ 4U

Rubina, OPAL1

NIR/ICG está previsto para el uso en un entorno electromagnético especificado debajo. El

cliente o usuario del cabezal de la cámara IMAGE1 S™ 4U Rubina, OPAL1

NIR/ICG se debería asegurar de que se use en dicho entorno.

Emisiones de RF

según 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

usarse en cualquier establecimiento que no sea doméstico y en aquellos que no estén

conectados directamente a la red pública de alimentación de baja tensión que alimenta

a los edificios de viviendas.

Emisiones de armónicos

según la norma CEI 6100032

Clase A

Emisión de fluctuaciones de tensión/flickers

según la norma CEI 6100033

Cumple

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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