background image

29

Bedienung des VITOM

®

 

3D-Exoskop-Systems

Die AEL-Funktion kann auf eine der 
programmierbaren Tasten des IMAGE1 PILOT 
gelegt werden. Sobald diese Taste gedrückt wird, 
ist die AEL-Funktion aktiv. Es erscheint das AEL-
Logo auf dem Bildschirm. Auch beim Einführen 
von Instrumenten, ändert sich die Belichtung nicht. 
Die AEL-Funktion ist solange aktiv, bis eines der 
folgenden Ereignisse eintrifft: 
•  AEL-Taste wird nochmals gedrückt 
•  Der Bildausschnitt (ROI) wird mit dem IMAGE1 

PILOT deutlich verändert 

•  Der Zoom wird mit dem IMAGE1 PILOT deutlich 

verändert 

Nach Deaktivierung der AEL-Funktion kehrt das 
VITOM

®

 3D in den normalen Belichtungsmodus 

zurück. 

7. 6 

Erweiterte  PIP-Swap-Funktion 

Die Funktion »PIP-Swap« kann auf eine der 
programmierbaren Tasten des IMAGE1 PILOT 
gelegt werden. 
Sobald mehr als ein Kamera-LINK-Modul an der 
IMAGE1 Plattform angeschlossen ist, erlaubt die 
PIP-Swap-Funktion einen Wechsel zwischen den 
als Primary und Secondary Source definierten 
Kameras. Das kann beispielsweise bei der 

e

ndoskopisch 

a

ssistierten 

M

ikrochirurgie (EAM) 

von Vorteil sein, um schnell von VITOM

®

 3D auf 

eine endoskopische Kamera umschalten zu 
können. 
Beim Drücken der mit »PIP-Swap« belegten 
Funktionstaste, wird das Bild zwischen 
der Primärquelle und der Sekundärquelle 
umgeschaltet. 

The AEL function can be assigned to one of the 
programmable buttons on the IMAGE1 PILOT. As 
soon as the button is pressed, the AEL function is 
active. The AEL logo appears on the screen. The 
exposure does not change even when inserting 
instruments. 
The AEL function remains active until one of the 
following events takes place:
•  AEL button is pressed again
•  The region of interest (ROI) is considerably 

changed using the IMAGE1 PILOT

•  The zoom is considerably changed using the 

IMAGE1 PILOT

After deactivating the AEL function, the VITOM

®

 

3D returns to the normal exposure mode. 

7. 6  Extended PIP-Swap function

The PIP-Swap function can be assigned to one of 
the programmable buttons on the IMAGE1 PILOT. 
As soon as more than one Camera LINK module 
is connected to the IMAGE1 Platform, the PIP-
Swap function permits switching between the 
cameras defined as Primary and Secondary 
Source. For example, this may be beneficial 
during 

e

ndoscopically 

a

ssisted 

m

icrosurgery 

(EAM) to quickly switch from the VITOM

®

 3D to an 

endoscopic camera. 
Pressing the function button to which PIP-Swap is 
assigned switches the image between the primary 
source and secondary source. 

Operation of the VITOM

®

 3D 

exoscope system

La función AEL puede asignarse a una de las 
teclas programables de la IMAGE1 PILOT. La 
función AEL se activa en cuanto se presiona esta 
tecla. Acto seguido, aparece el logotipo AEL en 
la pantalla. La exposición tampoco cambia al 
introducir instrumentos. 
La función AEL permanece activada hasta que 
ocurra una de las siguientes acciones:
•  La tecla AEL es presionada de nuevo
•  El encuadre de imagen (campo de interés) 

se modifica de forma notable con la IMAGE1 
PILOT

•  El zoom se modifica de forma notable con la 

IMAGE1 PILOT

Al desactivar la función AEL, el VITOM

®

 3D vuelve 

al modo normal de exposición. 

7. 6  Función “PIP-Swap” ampliada

La función “PIP-Swap” puede asignarse a una de 
las teclas programables de la IMAGE1 PILOT. 
En cuanto se conecta más de un módulo LINK 
para cámara a la plataforma IMAGE1, la función 
“PIP-Swap” permite conmutar entre las cámaras 
definidas como Primary Source (fuente primaria) y 
Secondary Source (fuente secundaria). Esto puede 
ser de utilidad, por ejemplo, en aplicaciones de 
microcirugía asistida por endoscopia (EAM), a fin 
de poder conmutar rápidamente del VITOM

®

 3D a 

una cámara endoscópica. 
Al presionar la tecla que tiene asignada la función 
“PIP-Swap”, la imagen conmuta de la fuente 
primaria a la fuente secundaria o viceversa. 

Manejo del sistema de 
exoscopio VITOM

®

 3D

Содержание IMAGE1 PILOT TC 014

Страница 1: ...GEBRAUCHSANWEISUNG TH 200 VITOM 3D Exoskop TC 014 IMAGE1 PILOT INSTRUCTION MANUAL TH 200 VITOM 3D Exoscope TC 014 IMAGE1 PILOT MANUAL DE INSTRUCCIONES TH 200 Exoscopio VITOM 3D TC 014 IMAGE1 PILOT ...

Страница 2: ......

Страница 3: ...ion manual is intended to aid you with proper connection and operation of the VITOM 3D in conjunction with the instruction manual for the IMAGE1 S All the necessary details and actions are clearly explained We thus ask that you read these manuals carefully before proceeding to work with the equipment Insert in the protective wallet and keep available for ready reference in a convenient and conspic...

Страница 4: ...eräteabbildungen 2 Geräteabbildungen 2 1 VITOM 3D Exoskop 1 2 3 4 5 6 7 8 9 Images of the device 2 Images of the device 2 1 VITOM 3D exoscope Imágenes del equipo 2 Imágenes del equipo 2 1 Exoscopio VITOM 3D ...

Страница 5: ...on to holding system 3 Rocker switch Scroll up down in menu programmed functions 4 Control button Open menu selection programmed functions 5 Handle 6 Connection for fiberoptic light cable 7 Stereo lens 8 Light outlet integrated illumination unit 9 Video connection cable Imágenes del equipo 2 1 1 Elementos de control indicadores conexiones y sus funciones 1 Botón giratorio para ajustar la orientaci...

Страница 6: ...tatus display 3 3D wheel for control of zoom focus and ROI as well as navigation through the menu 4 Right control button Cancel jump back from a menu and Esc 5 Left control button Open the camera menu Setup menu and selection 6 KSLOCK quick release coupling male for connection to a KARL STORZ holding system 3 Imágenes del equipo 2 2 IMAGE1 PILOT 2 2 1 Elementos de control indicadores conexiones y ...

Страница 7: ...packaging Consult instructions for use Catalogue number SN Serial number Number of products in the product packaging Fragile handle with care Keep dry 10 60 C 140 F 14 Temperature limit Rx ONLY Federal USA law restricts this device to sale by or on the order of a physician Symbols employed 3 Explicación de los símbolos 3 1 Símbolos utilizados en el producto Siga el manual de instrucciones Aparato ...

Страница 8: ...4 4 1 Descripción del aparato 4 5 Instrucciones de seguridad 5 5 1 Indicaciones de alarma y advertencia 5 5 2 Campos de aplicación 9 5 2 1 Uso previsto 9 5 2 2 Indicaciones 9 5 2 3 Contraindicaciones 9 5 3 Perfil del paciente 9 5 4 Perfil del usuario 9 5 5 Condiciones previstas de aplicación 10 5 5 1 Empleo 10 5 5 2 Otras condiciones previstas 10 5 6 Medidas de seguridad al emplear el instrumento ...

Страница 9: ...19 6 15 Desmontaje del sistema VITOM 3D después del uso 20 7 Manejo del sistema de exoscopio VITOM 3D 21 7 1 Ajuste del plano horizontal 21 7 2 Mando de las funciones ópticas del VITOM 3D con la IMAGE1 PILOT 21 7 2 1 Ajuste del zoom 22 7 2 2 Ajuste del enfoque 22 7 2 3 Encuadre de imagen seleccionado durante el zoom campo de interés 23 7 3 Control del IMAGE1 S con la IMAGE1 PILOT 25 7 4 Teclas de ...

Страница 10: ... frotado 42 9 4 Comprobación después de la limpieza 42 9 5 Limitación de la repreparación 42 10 Mantenimiento 43 10 1 Mantenimiento y verificación de seguridad 43 10 1 1 Mantenimiento 43 10 1 2 Verificación de seguridad 43 10 2 Reparaciones 44 10 3 Gestión de residuos 44 10 4 Programa de reparaciones 45 10 5 Responsabilidad 46 10 6 Garantía 46 11 Descripciones técnicas 47 11 1 Datos técnicos VITOM...

Страница 11: ...VITOM 3D exoscope the displayed site is enlarged on a 3D screen The VITOM 3D exoscope is compatible with the IMAGE1 S via the D3 LINK The VITOM 3D exoscope is positioned for use with the aid of a holding arm in such a way that the user can visualize the site The VITOM 3D exoscope is controlled using the control unit supplied IMAGE1 PILOT The control unit is secured to the operating table using a s...

Страница 12: ...nsure safe and efficient operation of the device 3 WARNING A Warning indicates that the personal safety of the patient or physician may be involved Disregarding a Warning could result in injury to the patient or physician 2 CAUTION A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the device 1 NOTE Notes contain additional informatio...

Страница 13: ... that they are complete free from damage and in full working order and have no unintentional rough surfaces sharp corners burred edges or projecting parts Care must be taken not to leave missing or broken off components inside the patient 3 WARNING Risk of injury Incorrect application of medical instruments poses a risk of injury for patients Users of medical instruments must have an appropriate m...

Страница 14: ...e lowest possible light output of the cold light source which still allows optimal illumination of the operating field 3 WARNING Risk of injury Optical radiation poses a risk of injury to eyes Never look into the free end of either a connected fiberoptic light cable or an exoscope Always wear standardized protective equipment when using lasers 3 WARNING Risk of injury Overloading the instrument by...

Страница 15: ...y unauthorized staff voids the warranty 3 WARNING Risk of fatal injury In the case of patients with cardiac pacemakers it must be ensured that the proximal end furthest from the patient of the telescope is not positioned less than 2 cm from the pacemaker The device generates a magnetic field at the setting ring which can cause cardiac pacemakers or other electrical devices to malfunction 3 WARNING...

Страница 16: ...ources are not intended for use in ophthalmology the use of the VITOM 3D system is also contraindicated in this field 5 3 Patient profile The use of the VITOM 3D is not limited to a certain patient profile sex age weight etc The attending physician must assess a patient s health for the relevant application and declare it suitable 5 4 User profile Adequate and recognized skills in the relevant app...

Страница 17: ...ient must be treated and kept under observation with the usual medical care This includes keeping a check on the progress of treatment as well as monitoring the vital signs and the anesthetic 1 NOTE Any treatment may only be performed if visual observation of the action of the device is ensured 5 5 2 Other intended conditions Frequency of use one or more times a day Length of use from a few minute...

Страница 18: ...esponsibility to make sure the instrument is safe and operates properly before using it During treatment in conjunction with the VITOM 3D exoscope the patient must be treated and kept under observation using the usual medical care This includes monitoring sterile application conditions where required by the type of intervention Instrucciones de seguridad 5 6 Medidas de seguridad al emplear el inst...

Страница 19: ...ECT module TC 200 EN 1 IMAGE1 S D3 LINK module TC 302 1 32 3D monitor TM 323 1 3D polarization glasses 9800 GF VITOM 3D exoscope 1 VITOM 3D exoscope TH 200 1 IMAGE1 PILOT TC 014 1 Sterile cover for VITOM 3D exoscope TH 001 1 Sterile cover for IMAGE1 PILOT 041150 20 Recommended light source 1 Power LED 300 TL 300 1 Light cable with a diameter of 4 8 mm e g 495 TIP or 495 VIT Holding arms 1 Suitable...

Страница 20: ...lly provided or contact your KARL STORZ service partner If it is necessary to upgrade the hardware of the compatible Link module TC 302 the system will show you this For more information on this please contact your KARL STORZ service partner 6 4 Before each use Before each use the instrument must be inspected for damage especially around the distal end cover glass light outlet Before each use the ...

Страница 21: ...e VITOM 3D exoscope 6 6 Attaching the VITOM 3D exoscope to the holding arm For operation of the VITOM 3D exoscope a KARL STORZ holding arm e g endoscopic holding system which can carry a load of at least 2 kg is required Depending on the holding system the VITOM 3D exoscope is attached to the KARL STORZ holding system using a clamping jaw 28272 VTK or 28272 VTP Attach the clamping jaw to the holdi...

Страница 22: ... VITOM 3D can be swiveled in all directions either via the ball joint on the clamping jaw Art no 28272 VTK or via the integrated ball joint in the POINT SETTER 1 NOTE Before every intervention check whether the VITOM 3D exoscope can be positioned using the holding system selected in such a way that optimal visualization of the site is ensured 6 7 Connecting the light cable to the VITOM 3D exoscope...

Страница 23: ...M 3D exoscope and features a plastic frame with a transparent screen in the distal area Remove the sterile cover from its packaging see Fig G Insert the plastic frame over the cover glass and light outlet on the distal end of the VITOM 3D exoscope see Fig H Then pull the cover over the VITOM 3D exoscope and holding arm see Fig I 1 NOTE The cover TH 001 has been specially designed for the VITOM 3D ...

Страница 24: ...16335DF The IMAGE1 PILOT is equipped with a KSLOCK quick release coupling male on its underside and can thus be easily attached to KARL STORZ articulated stands see Fig J To this end open the KSLOCK quick release coupling female on the articulated stand by turning in the OPEN direction and insert the IMAGE1 PILOT so that it clicks into place audibly Make sure that the IMAGE1 PILOT is correctly loc...

Страница 25: ...hing the USB connection or powering up the IMAGE1 S system 6 10 Fitting the IMAGE1 PILOT with a sterile cover The IMAGE1 PILOT cannot be sterilized and is therefore fitted with a sterile cover during the intervention 041150 01 Remove the sterile cover from its packaging and use it to cover the control unit and articulated stand see Fig O Make sure that the elastic insert on the tip of the sterile ...

Страница 26: ...d the instruction manuals for the IMAGE1 S the light source the light cable and the monitor 6 14 Optimal light efficiency 1 NOTE The entrance and exit faces of the light cable and VITOM 3D must be kept clean if optimal light transmission is to be maintained The light cable must first be unscrewed see Fig R Then clean the entrance and exit faces with a cotton swab soaked in cleaning solution and th...

Страница 27: ...TOM 3D exoscope and IMAGE1 PILOT from the holding system perform a wipe down disinfection also see chapter 8 Reprocessing and keep both safe 1 NOTE The handle on the VITOM 3D exoscope can become very hot during operation especially on the sides and on the light cable connection over 50 C under certain circumstances This is not a malfunction It is recommended to allow the system to briefly cool dow...

Страница 28: ...ble buttons on the IMAGE1 PILOT or to the camera head buttons Also see chapter 7 4 Programmable function buttons on the IMAGE1 PILOT 1 NOTE To avoid damage to the VITOM 3D exoscope do not turn the knob beyond the limit stops 7 2 Controlling the optical functions of the VITOM 3D via the IMAGE1 PILOT Most of the functions of the VITOM 3D exoscope can be remote controlled easily via the IMAGE1 PILOT ...

Страница 29: ...ecisely 7 2 2 Adjusting the focus The working distance of the VITOM 3D can be variably adjusted from 20 50 cm The 3D Wheel enables focusing of the image at any time To bring a lower level greater working distance into focus turn the 3D Wheel clockwise To bring a higher level shorter working distance into focus turn the 3D Wheel counterclockwise see Fig Y The more you turn the 3D Wheel the faster y...

Страница 30: ...required direction see Fig Z and a The more you press the 3D Wheel the faster you will be able to move the region of interest 1 NOTE The region of interest can only be moved in the image level This does not change the angle of view of the VITOM 3D relative to the object The region of interest can only be moved with a magnification setting of 1x The movement range is limited The image cannot be mov...

Страница 31: ...large rectangle shows the available overview area As soon as you use the zoom a small filled rectangle which represents the selectable region of interest appears The size of the rectangle varies with the selected zoom level If the region of interest is moved the rectangle also moves and shows the position within the available overview area Under the overview area a bar shows the relative zoom leve...

Страница 32: ...ssary see Fig c As soon as the menu of the IMAGE1 S is called up using the ENTER button you can navigate through the menu adjust settings or call up functions by moving the 3D Wheel You can exit the menu by pressing the ESC button The following table offers an overview of the functions 1 NOTE As long as the IMAGE1 S menu is active the VITOM 3D functions e g zoom and focus cannot be controlled Oper...

Страница 33: ...r button on the left Call up the IMAGE1 S menu and confirm a function Pressing the ENTER button for longer calls up the Setup menu of the IMAGE1 S Move the 3D Wheel to navigate through the IMAGE1 S menu Press the 3D Wheel to confirm your selection Pull the 3D Wheel to jump back from a menu or cancel an action Operation of the VITOM 3D exoscope system 1 2 3 Teclas programables 1 4 para acceso rápid...

Страница 34: ...es Brightness Nothing Source swap AEL Activate Image Flip 7 5 Advanced Exposure Levelling AEL function The function Advanced Exposure Levelling AEL stabilizes the Exposure control in situations with extreme illumination conditions and prevents the VITOM 3D from under or overexposing the image for example when a shiny instrument is inserted The effect is shown schematically in the following images ...

Страница 35: ...nd the operating field is displayed too dark The exposure is stabilized when the AEL function is activated The reflection on the instrument may become larger however the operating field is displayed well exposed Operation of the VITOM 3D exoscope system Imagen con una exposición adecuada debido al control automático de la exposición Al introducir un instrumento con mucho brillo el control automáti...

Страница 36: ... the AEL function the VITOM 3D returns to the normal exposure mode 7 6 Extended PIP Swap function The PIP Swap function can be assigned to one of the programmable buttons on the IMAGE1 PILOT As soon as more than one Camera LINK module is connected to the IMAGE1 Platform the PIP Swap function permits switching between the cameras defined as Primary and Secondary Source For example this may be benef...

Страница 37: ... VITOM 3D exoscope can alternatively be operated via the touchpad 1 NOTE For safety reasons always connect the keyboard to the IMAGE1 S Zoom By moving your finger upward on the touchpad the image view is magnified By performing a downward movement on the touchpad the image view is reduced Focus Move to the left on the touchpad to focus in the distance Operation of the VITOM 3D exoscope system 7 7 ...

Страница 38: ...ing the ROI By holding the left mouse button depressed and moving your finger on the touchpad the magnified region of interest can be moved in the x and y direction Operation of the VITOM 3D exoscope system en tanto que un movimiento hacia la derecha sobre el panel táctil sirve para enfocar a corta distancia Desplazamiento del campo de interés El encuadre de imagen ampliado puede desplazarse en la...

Страница 39: ...k while storing Do not expose the VITOM 3D unprotected to direct sunlight or excessive heat When returning the VITOM 3D for service the user must ensure the equipment being returned is clean and wipe down disinfected The entrance and exit faces of the light cable and exoscope must always be kept clean see corresponding instruction manual to ensure optimal reproduction of the image 2 CAUTION Chemic...

Страница 40: ...onnecting cable and of the light cable must also be completely dry before connecting NEVER PICK UP THE VITOM 3D BY ITS CABLE Always pick up the set by the instrument handle first followed by the cable and connector The cable contains tiny electronic conductors and should be treated gently and carefully PROTECT THE VITOM 3D FROM DIRECT SUNLIGHT OR EXCESSIVE HEAT HANDLE THE SYSTEM WITH CARE avoiding...

Страница 41: ...hemothermal disinfection Desinfección química Thermische Desinfektion Thermal disinfection Desinfección térmica Konnektierung Connection Conexión Dampfsterilisation Steam serilization Esterilización por vapor STERRAD 50 100S 200 STERRAD NX STERRAD 100NX STERRAD 100NX DUO Cycle AMSCO V PRO 1 Ethylenoxid 100 EO Ethylene oxide 100 EO Óxido de etileno al 100 OE Niedertemperatur Dampf Formaldehyd Verfa...

Страница 42: ... indication that reprocessing has not been carried out or has been carried out incorrectly Reprocess the medical devices before initial use and before and after every subsequent use using validated procedures 3 WARNING When carrying out any work on contaminated medical devices the guidelines of the Employers Liability Insurance Association and equivalent organizations striving to ensure personal s...

Страница 43: ...erior surfaces of the medical device with a disposable cloth moistened with disinfectant or a ready to use soaked disinfectant cloth Due to their protein fixating effect and possible material incompatibility alcohol based agents must not be used The chemical manufacturer s specifications concerning material compatibility and necessary exposure time for the disinfectant must be observed At the end ...

Страница 44: ...erwards a functional check must be carried out 8 5 Reprocessing limits The product s service life and correct functioning are largely determined by mechanical stress and chemical influences within the scope of reprocessing and application 2 CAUTION Inspect the video connecting cable and the fiberoptic light cable for breaks or cracks before and after disinfection as well as prior to subsequent use...

Страница 45: ...xcessive heat Prior to returning for service the VITOM 3D must be thoroughly cleaned per validated procedures The entrance and exit faces of the light cable and exoscope must always be kept clean see corresponding instruction manual to ensure optimal reproduction of the image 2 CAUTION Chemical residue on the card edge connector can cause failure of the camera electronics 2 CAUTION Heat from the l...

Страница 46: ...tely dry before connecting NEVER PICK UP THE VITOM 3D BY ITS CABLE Always pick up the set by the instrument handle first followed by the cable and connector The cable contains tiny electronic conductors and should be treated gently and carefully PROTECT THE VITOM 3D FROM DIRECT SUNLIGHT OR EXCESSIVE HEAT HANDLE THE SYSTEM WITH CARE avoiding extreme impacts to the device When transporting use the o...

Страница 47: ...ón química Thermische Desinfektion Thermal disinfection Desinfección térmica Konnektierung Connection Conexión Dampfsterilisation Steam serilization Esterilización por vapor STERRAD 50 100S 200 STERRAD NX STERRAD 100NX STERRAD 100NX DUO Cycle AMSCO V PRO 1 Ethylenoxid 100 EO Ethylene oxide 100 EO Óxido de etileno al 100 OE Niedertemperatur Dampf Formaldehyd Verfahren NTDF Low temperature steam and...

Страница 48: ...non sterile medical devices poses a risk of infection for patients users and third parties Inspect medical devices for visible contamination Visible contamination is an indication that reprocessing has not been carried out or has been carried out incorrectly Reprocess the medical devices before initial use and before and after every subsequent use using validated procedures 3 WARNING When carrying...

Страница 49: ... free from any visible signs of damage cuts dents or scratches etc that may trap residual debris If the device shows any damage contact KARL STORZ for repairs 9 5 Reprocessing limits The product s service life and correct functioning are largely determined by mechanical stress and chemical influences within the scope of reprocessing and application 2 CAUTION Inspect the video connecting cable and ...

Страница 50: ... persons who due to their training knowledge and practical experience are able to properly carry out such metrological checks and who are not subject to any instructions as far as such checking activities are concerned Visual inspection Check the device and accessories for any mechanical damage which may impair functionality Check that the labels relevant to safety are legible Electric measurement...

Страница 51: ...r the lens Opening these sealed assemblies affects the camera s tightness and voids all warranties The covers on the camera processor must only be removed by authorized personnel 10 3 Disposal This device has been marked in accordance with the European Directive on waste electrical and electronic equipment WEEE At the end of its useful operating life dispose of the device as electronic scrap Pleas...

Страница 52: ...dden to ship contaminated medical 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 equipment to the sender Repairs modifications or expansions which are not carried out by KARL STORZ or by experts authorized by KARL STORZ will invalidate all warranty rights KARL STORZ gives ...

Страница 53: ...le laws and standards and the device has been used in accordance with its operating instructions at all times 10 6 Warranty The warranties 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 modificati...

Страница 54: ...ary knob for mechanical image alignment 90 Interfaces Video interface for the IMAGE1 S D3 LINK module Interface for fiberoptic light cable Interface for attaching a holding system using the clamping jaw 28272 VTK or 28272 VTP Operating temperature 5 C 30 C Storage Ambient temperature 10 C 60 C Humidity 5 95 non condensing Air pressure 500 1060 hPa Descripciones técnicas 11 Descripciones técnicas 1...

Страница 55: ...th 6 DoF Degrees of Freedom 4 programmable buttons 2 buttons for menu navigation Interfaces USB interface for operation with the IMAGE1 S CONNECT KSLOCK for fast and secure fixation on KARL STORZ holding systems Operating temperature 5 C 30 C Storage Ambient temperature 10 C 60 C Humidity 5 85 non condensing Air pressure 500 1060 hPa Descripciones técnicas 11 2 Datos técnicos de la IMAGE1 PILOT Di...

Страница 56: ... protection against electric shock Protection Class III Degree of protection against electric shock Defibrillation protected Type CF 11 2 2 Directive compliance for VITOM 3D In accordance with the Medical Device Directive MDD This medical device belongs to Class I This medical device bears the CE mark in accordance with MDD 93 42 EEC Descripciones técnicas 11 2 1 Conformidad con las normas para el...

Страница 57: ...ternal functioning 1 NOTE The tables and guidelines that are included in this chapter provide information to the customer or user that is essential in determining the suitability of the equipment or system for the electromagnetic environment of use and in managing the electromagnetic environment of use to permit the equipment or system to perform its intended use without disturbing other equipment...

Страница 58: ...ces of medical equipment 3 WARNING The use of accessories and cables other than those specified in the KARL STORZ instruction manual may result in increased emissions or decreased immunity of the device The accessories and cables listed below have been shown to comply with the requirements of IEC 60601 1 2 When using accessories and cables other than those specified here it is the responsibility o...

Страница 59: ...den Aussendung von Oberschwin gungen nach IEC 61000 3 2 Klasse A Aussendungen von Spannungs schwankungen Flicker nach IEC 61000 3 3 Stimmt überein Information on electromagnetic compatibility EMC Table 1 Guidance and manufacturer s declaration electromagnetic emissions The VITOM 3D exoscope model TH 200 is intended for use in the environment speciǫed below The customer or user of the VITOM 3D exos...

Страница 60: ... Grupo 1 El exoscopio VITOM 3D modelo TH 200 usa energía de RF solo para su función interna Por ello sus emisiones de RF son muy bajas y no es probable que causen cualquier interferencia en los equipos electrónicos en las proximidades Emisiones de RF según la norma CISPR 11 Clase A El exoscopio VITOM 3D modelo TH 200 es adecuado para usarse en cualquier establecimiento que no sea doméstico y en aq...

Страница 61: ... Erde 1 kV Spannung Außenleiter Außenleiter 2 kV Spannung Außenleiter Erde Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts oder Krankenhausumgebung entsprechen Spannungseinbrüche Kurzzeitunterbrechungen und Schwankungen der Versorgungsspannung nach IEC 61000 4 11 5 UT 95 Einbruch der UT für 1 2 Periode 40 UT 60 Einbruch der UT für 5 Perioden 70 UT 30 Einbruch der UT für 2...

Страница 62: ...Surge acc to IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines acc to IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5...

Страница 63: ...ún la norma CEI 61000 4 5 1 kV tensión línea externa línea externa 2 kV tensión línea externa tierra 1 kV tensión línea externa línea externa 2 kV tensión línea externa tierra La calidad de la red de alimentación debe ser la de un entorno comercial típico o la de un hospital Caídas de tensión interrupciones breves y variaciones de tensión en las líneas de alimentación según norma CEI 61000 4 11 5 ...

Страница 64: ...eringer als der Übereinstimmungspegel sein b In der Umgebung von Geräten die das folgende Bildzeichen tragen sind Störungen möglich 7 Anmerkung 1 Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich Anmerkung 2 Diese Leitlinien mögen nicht in allen Fällen anwendbar sein Die Ausbreitung elektromagnetischer Größen wird durch Absorptionen und Reflexionen der Gebäude Gegenstände und Menschen beeinfl...

Страница 65: ... and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol 7 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not a...

Страница 66: ...Las intensidades del campo desde el transmisor fijo de RF según se determina por un estudio electromagnético del lugar a debería estar por debajo del nivel de conformidad en cada rango de frecuencia b Pueden producirse interferencias en la vecindad del equipo marcado con el siguiente símbolo 7 Nota 1 A 80 MHz y 800 MHz se aplica el rango de frecuencia más alto Nota 2 Estas directrices no se pueden...

Страница 67: ...MHz C 80 MHz bis 800 MHz C 800 MHz bis 2 5 GHz F 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 Gleichung ermittelt werden die zur jeweiligen Spalte gehört wobei P die maximale Nennleistung des Senders in Watt W gemäß An...

Страница 68: ...ons equipment Rated maximum output power of transmitter W Separation distance d m according to frequency of transmitter 150 kHz to 80 MHz D 80 MHz to 800 MHz D 800 MHz to 2 5 GHz F 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 69: ...o Potencia nominal del transmisor W Distancia de separación d m conforme a la frecuencia del transmisor 150 kHz hasta 80 MHz C 80 MHz hasta 800 MHz C 800 MHz hasta 2 5 GHz F 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 en metros m se puede determi...

Страница 70: ...ce E P E Patriarhou Grigoriou E 34 54248 Thessaloniki Greece Phone 30 2310 304868 Fax 30 2310 304862 E Mail info karlstorz gr 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 Mo...

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Страница 72: ...KARL STORZ GmbH Co KG Mittelstraße 8 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon 49 0 7461 708 0 Telefax 49 0 7461 708 105 E Mail info karlstorz com Web www karlstorz com ...

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