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9. 3. 1 Normenkonformität

(für UI400)

Nach IEC

60601-1, UL/cUL (ANSI/AAMI ES

60601-1) und CAN/CSA C22.2 No. 60601-1:

• Art des Schutzes gegen elektr. Schlag:

Schutzklasse I

• Grad des Schutzes gegen elektr. Schlag:

Anwendungsteil des Typs CF

• IP-Schutzart: IP21

Nach IEC 60601-1-2, FCC-B:

Beachten Sie die Hinweise zur Elektromag neti-
schen Verträglichkeit im Kapitel 11 (S. 56-69).

9. 3. 2 Richtlinienkonformität

(für UI400)

Nach Medical Device Directive (MDD):

Medizinprodukt der Klasse IIb
Dieses Medizinprodukt ist nach der Medical
Device Directive (MDD) 93/42/EEC mit
CE-Kennzeichen versehen.

HINWEIS:

Die dem CE-Kennzeichen nach-

gestellte Kennnummer weist die zuständige
Benannte Stelle aus.

Technische Beschreibung

Technische Daten

Technical description

Technical data

Descripción técnica

Datos técnicos

9. 3. 1 Standard compliance

(for UI400)

According to IEC

60601-1, UL/cUL (ANSI/AAMI

ES 60601-1) and CAN/CSA C22.2 No. 60601-1:

• Type of protection against electric shocks:

Protection Class I

• Degree of protection against electric shocks:

Applied part type CF

•

Type of IP protection: IP21

According to IEC 60601-1-2, FCC-B:

Observe the information on electromagnetic
compatibility in chapter

11 (pages 56-69).

9. 3. 2 Directive compliance

(for UI400)

According to the Medical Device Directive (MDD):

This medical product belongs to Class IIb.
This medical product bears the CE mark in
accordance with the Medical Device Directive
(MDD) 93/42/EEC.

NOTE:

The code number after the CE mark

indicates the responsible noti

ed body.

9. 3. 1 Conformidad con las normas

(para UI400)

Según IEC

60601-1, UL/cUL (ANSI/AAMI ES

60601-1) y CAN/CSA C22.2 No. 60601-1:

• Tipo de protección contra descarga eléctrica:

Clase de protección I

• Grado de protección contra descarga eléctrica:

Pieza de aplicación del tipo CF

•

Tipo de protección IP: IP21

Según CEI 60601-1-2, FCC-B:

Observe las indicaciones sobre compatibilidad
electromagnética en el capítulo

11 (págs. 56-69).

9. 3. 2 Conformidad con las directivas

(para UI400)

Según la Medical Device Directive (MDD):

Producto médico de la clase IIb
Este producto médico está provisto del símbolo CE
según la Medical Device Directive (MDD) 93/42/CEE.

NOTA:

El número de identi

cación pos-

puesto al símbolo CE designa el organismo
noti

cado competente.

Содержание ENDOFLATOR 40

Страница 1: ...GEBRAUCHSANWEISUNG UI400 ENDOFLATOR 40 INSTRUCTION MANUAL UI400 ENDOFLATOR 40 MANUAL DE INSTRUCCIONES UI400 ENDOFLATOR 40 ...

Страница 2: ......

Страница 3: ...ll of our products this product is also the result of years of experience and careful manufacturing You and your organization have decided in favor of a modern high quality product from KARL STORZ This instruction manual is intended to serve as an aid in the proper setup installation and operation of the ENDOFLATOR 40 All of the necessary details and actions are clearly explained Please read these...

Страница 4: ...2 Geräteabbildungen 1 4 6 7 8 9 2 3 5 0 q IV Imágenes del equipo Images of the equipment Geräteabbildungen 2 Images of the equipment 2 Imágenes del equipo ...

Страница 5: ...ontrols displays connectors and their uses 1 Power switch O off 2 Touch screen 3 Insufflation connection to patient 4 Gas connection American connection 5 SCB connectors 6 Service interface concealed 7 Ethernet interface concealed 8 Potential equalization connector 9 Power cord socket 0 Line fuse holder q Holder for CO2 bottle optional cat no UI005 3 Elementos de control indicadores conexiones y s...

Страница 6: ...oHS Este aparato está identificado con forme a la directiva europea referi da a aparatos eléctricos y electró nicos viejos Waste Electrical and Electronic Equipment o WEEE Fabricante Symbole auf Label und Verpackung des Gerätes Die Bedeutung der auf Label oder Verpackung aufgedruckten Symbole können Sie dem Beipackzettel Verpackungssymbole Mat Nr 96216316DF entnehmen Diesen können Sie unter www ka...

Страница 7: ...e audio encendida Señal de audio apagada Acometida presión de entrada correcta Acometida presión de entrada demasiado baja o demasiado alta Botella de gas presión de entrada por encima de 40 bares Botella de gas presión de entrada entre 40 y 30 bares Botella de gas presión de entrada entre 30 y 10 bares Botella de gas presión de entrada por debajo de 10 bares Botella de gas presión de entrada dema...

Страница 8: ...duct must not be resterilized CE mark Do not use the product if the packaging has been damaged Consult instructions for use Rx ONLY In the USA federal law restricts this device to sale or use by or on the order of a physician Store in a dry place Store out of direct sunlight Sterilized with ethylene oxide Use by date of the product Production batch label 4 3 Símbolos para etiquetar filtro de gas F...

Страница 9: ...and assistants 13 6 5 Intended conditions of use 13 6 5 1 Use 13 6 5 2 Other intended conditions 13 6 5 3 User position 14 6 6 Safety precautions at the installation site 15 6 7 Safety precautions when operating the device 15 6 8 Safety features 16 6 8 1 Self test 16 6 8 2 Monitoring during operation 16 7 Installation and operating instructions 18 7 1 Unpacking the equipment 18 7 2 Basic equipment...

Страница 10: ...istration 32 7 5 5 Device information 33 8 Maintenance 34 8 1 Fuse replacement 34 8 2 Reprocessing 35 8 2 1 Reprocessing of the ENDOFLATOR 40 36 8 2 2 Reprocessing of insufflation tube set with gas filter for single use sterile 37 8 2 3 Reprocessing of reusable insufflation tube 37 8 2 3 1 Preparation for cleaning and disinfection 37 8 2 3 2 Manual precleaning 37 8 2 3 3 Manual cleaning 38 8 2 3 4...

Страница 11: ...46 9 1 Signals 46 9 1 1 Visual signals 46 9 1 2 Acoustic signals 47 9 2 Troubleshooting 49 9 3 Technical data 51 9 3 1 Standard compliance for UI400 52 9 3 2 Directive compliance for UI400 52 9 4 Technical documentation 53 10 Spare parts recommended accessories 54 10 1 Spare parts accessories 54 10 2 Accessories 55 11 Electromagnetic Compatibility EMC information 56 12 Subsidiaries 70 8 3 2 Contro...

Страница 12: ...the pressure up to max 15 mmHg and flow ranges up to max 15 l min To quickly compensate for the considerable loss of gas occurring in complex laparoscopic operations the ENDOFLATOR 40 has been designed for a high flow rate of up to 40 l min The ENDOFLATOR 40 is operated directly via a color screen with a touch sensitive surface touch screen or by an external prime control unit via the SCB interfac...

Страница 13: ...ied by a pictogram 3 WARNING A Warning indicates that the personal safety of the patient or physician may be endangered Failure to observe 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 A Note provides special information regarding the operati...

Страница 14: ...a 16 of the 3rd edition of the IEC 60601 1 3 WARNING Grounding reliability can only be achieved when the device is connected to a Hospital only or Hospital Grade outlet Check the plugs and cables regularly and do not use if damaged 3 WARNING To avoid the risk of an electric shock this device may only be connected to a power supply network with a protective conductor 3 WARNING Test this equipment p...

Страница 15: ...ntinuous operation a self test must be performed Take note of the warnings to ensure that the device is fully functional 3 WARNING The device must not be used if either the touch screen or display is defective 3 WARNING If the touch screen does not react when pressed you must turn the device off 3 WARNING Do not press several points on the touch screen simultaneously 3 WARNING Only sterile CO2 gas...

Страница 16: ...should fail 3 WARNING For safety reasons do not simultaneously touch the device output sockets and the patient 3 WARNING Risk of infection Incorrectly reprocessed medical devices expose patients users and third parties to a risk of infection as well as the risk that the medical device may malfunction Observe the Cleaning Disinfection Care and Sterilization of KARL STORZ Instruments instructions an...

Страница 17: ...et may be impaired and the tube set must not be used 3 WARNING Follow the country speciǫc regulations laws for the disposal of accessories 3 WARNING Avoid allowing Ǭuids to enter the housing Do not store liquids on or directly above the device If despite the precautions liquid enters the device sufǫcient time should be planned for evaporation this also applies for the formation of condensation 3 W...

Страница 18: ...estinal tract e g TEO colonoscopy In addition the ENDOFLATOR 40 is also designed to expulse ambient air in open and endoscopically assisted cardiac surgery and endoscopic vessel harvesting 3 WARNING Only sterile CO2 gas may be used Use of the device in fields other than those indicated above is not allowed for safety reasons The ENDOFLATOR 40 may only be operated with tubing sets and accessories w...

Страница 19: ...n doubt contact your representative on site or the technical customer service 6 2 2 Contraindications No contraindications relating directly to the products used for CO2 insufflation are currently known The use of an insufflator is contraindicated if in the opinion of a qualified physician such an application would pose risks to the patient e g due to the patient s general condition The device is ...

Страница 20: ...tic reactions The risk of a metabolic imbalance due to increased CO2 absorption is increased for patients with sickle cell anemia or pulmonary insufficiency Dehydration For longer operations with high gas levels insufflation can lead to a drying out of the tissues or cause tissue damage Unnecessary leaks must be avoided for this reason The decisive factor for the incidence of these complications i...

Страница 21: ...e use of the device No physical impairments which limit or prevent perception of acoustic or visual alarm signals 6 5 Intended conditions of use 6 5 1 Use The device is intended for use in hospitals and doctors offices The technical data and ambient conditions are described in the instruction manual 6 5 2 Other intended conditions Frequency of use one or more times a day Length of use from a few m...

Страница 22: ...ld always be standing in front of the device within a cone of vision with an opening angle of 45 at a distance of approx 30 70 cm to the front panel For observation of the actual values during the application a visual distance from the device of 2 m is assumed Control puede controlarse a través del KARL STORZ SCB El equipo está fuera del área estéril 6 5 3 Posición del usuario Para el manejo del a...

Страница 23: ...osive chemicals e g skin disinfectants and fast acting surface disinfectants The device is equipped with a connector for attaching a ground line It should be connected up in accordance with the applicable national regulations 6 7 Safety precautions when operating the device It is the user s responsibility to make sure the equipment is safe and operates properly before use This device has been test...

Страница 24: ...during insufflation the intracorporeal pressure rises above the set setpoint value by a limit dependent on the setpoint value for more than 3 seconds an acoustic information signal sounds see chapter 9 1 2 and the gas supply is stopped After a time period which can be set 5 99 seconds the overpressure is actively reduced via a blow off valve Mode specific pressure monitoring Monitoring of gas supp...

Страница 25: ... stages and the flow measurement are equipped with safety pressure release valves The function of the mechanical high pressure regulator is monitored 1 NOTE If the monitoring system recognizes an error which renders safe functioning seemingly impossible the device is transferred into a safe state From this state the device can only be reset by turning off the power supply Medidas pasivas de seguri...

Страница 26: ...TORZ Set no UI400S1 1 ENDOFLATOR 40 UI400 1 Power cord 400A 5 Insufflation tube sets with gas filter for single use sterile 1 Universal wrench 20400030 1 SCB connecting cable 20090170 length 100 cm 1 Instruction manual 1 CO2 supply tube customized Montaje e instrucciones operativas Installation and operating instructions 7 Montaje e instrucciones operativas 7 1 Desembalaje Extraiga cuidadosamente ...

Страница 27: ...ing performed by qualified personnel 7 3 2 Connecting the power cord 3 WARNING The device may only be operated at the voltage stated on the rating plate 4 Push the power cord into the power socket as far as it will go 3 WARNING Only connect disconnect the power plug to from the power supply outside of areas subject to explosion hazards 3 WARNING The instrument may only be operated with the power c...

Страница 28: ...ng cable from being pulled out accidentally the SCB connector possesses a protection device Pull back the protection device of the SCB connector and insert the connector into one of the SCB sockets Connect the other end of the cord to the KARL STORZ SCB KARL STORZ Communication Bus control unit or other SCB devices see KARL STORZ SCB control NEO System Instruction Manual 7 3 3 KARL STORZ SCB 1 NOT...

Страница 29: ...e enclosed screws of length 6 mm Insert the CO2 bottle vertically into the holder and close the locking clip 3 WARNING Only sterile CO2 gas may be used Montaje e instrucciones operativas Installation and operating instructions 7 3 4 Fijación de la botella de CO2 al aparato opcional Monte el soporte disponible opcionalmente en el lado posterior del aparato Utilice para ello los torni llos incluidos...

Страница 30: ...aprox vuelta en el sentido contra rio al de las agujas del reloj 7 3 9 Connecting to the central gas supply Connect the low pressure tube e g UI001 see the section Accessories to the device s gas connection and connect the other end directly to the wall outlet of the central gas supply 3 3 7 bar 7 4 Commissioning 1 NOTE The gas supply must be connected when the device is switched on otherwise an e...

Страница 31: ...aje e instrucciones operativas Installation and operating instructions 1 Accione el interruptor de red 1 Después de la conexión en primer lugar aparece una pantalla con el logotipo de KARL STORZ A continuación aparece una pantalla blanca Durante este tiempo el aparato lleva a cabo un test automático En caso de finalizar el test con resultados positivos suena una señal acústica de estado dispuesto ...

Страница 32: ...g Montaje e instrucciones operativas Installation and operating instructions Si el test automático falla aparece la pantalla Safe State Estado seguro del sistema con un men saje de información y suena una señal acústica de información En este caso compruebe si el aparato ha sido conectado correctamente y los preparativos se han llevado a cabo conforme a la Instrucción Usted encontrará otras indica...

Страница 33: ...rm the selection with 1 or reject the changes with 2 7 Select the desired gas supply source under Source of gas supply Confirm the selection with 1 or reject the changes with 2 7 4 2 Normal commissioning After successfully starting see section Commissioning for the first time the Working screen appears 1 NOTE In routine operation insufǬation can be started and the device settings changed from the ...

Страница 34: ... the insufǬation connection and the insufǬation tube to prevent the risk of contamination of the device due to the reverse Ǭow of gas or body Ǭuid The CO2 ǫlter must be replaced after each use 2 Attach the insufflation tube to the CO2 gas filter and connect the other end of the insufflation tube to the VERESS needle 1 NOTE In the case of the disposable insufǬation tube set the ǫlter is ǫrmly conne...

Страница 35: ...after a few seconds is released via the overpressure valve blow off valve This is repeated cyclically 6 Observe the instrument s conduct over a 30 second period 1 NOTE The Ǭow display may only show values greater than zero for short periods If the set pressure is only reached slowly even when the instrument s stopcock is closed or if you note stationary Ǭow rates of 0 2 l min or more there is a le...

Страница 36: ... 1 NOTE To compensate for the considerable loss of gas occurring in complex operations the High Flow mode has been ǫtted with a Ǭow rate of up to 40 l min For particularly sensitive applications the device features a SENSITIVE mode which is characterized by low insufǬation pressure as well as special safety limits in the pressure up to max 15 mmHg and Ǭow ranges up to max 15 l min 3 WARNING Always...

Страница 37: ... Reset the volume display using the 0 button 4 Insert the VERESS needle and open the locking lever Press the START STOP button to initiate the insufflation process 1 NOTE In order to use the maximum device Ǭow in the High Flow mode HICAP instruments with a suitable connection must be used The LUER lock connection ǫtted to the end of the insufǬation tube must be removed in this case 1 NOTE In the c...

Страница 38: ...cierre la válvula de la botella de CO2 en el caso de utilizarse ali mentación de gas a alta presión y desconecte el tubo flexible de insuflación utilizado incluyendo el filtro del aparato 30 Aufstellen und Bedienhinweise Montaje e instrucciones operativas Installation and operating instructions Displays The insufflation pressure flow and volume of the gas used are continuously displayed in the Wor...

Страница 39: ...are described in the Service Manual 7 5 3 System Log The System Log contains the saved information and alarms Each entry occupies one row and consists of a sequential number date time and alarm information ID The most recent entry is allocated the number 000 7 5 Ajustes Ajustes del aparato Device Settings Servicio Técnico Service Registro del sistema System Log Administración Administration Inform...

Страница 40: ...erface 3 Select Export system log on the Administration screen Exporting of the system log starts 1 NOTE The current status is shown via a progress bar This progress bar shows that the export is underway however it does not show how far it has advanced Unit pressure Select the desired unit mmHg or hPa under Unit pressure Confirm the selection with 1 or reject the changes with 2 7 5 4 Administració...

Страница 41: ...the set time this is reduced If the overpressure cannot be reduced the device emits a warning 7 5 5 Device information The following elements are displayed Device serial number Operating hours Software versions Software license information Ajuste de fecha y hora Date and Time El ajuste de la fecha y la hora es autoexplicativo Confirme la opción seleccionada pulsando 1 o bien cancele los cambios pu...

Страница 42: ...screw bits on the line fuse holder 0 using a screwdriver or another suitable tool 3 WARNING Only use fuses of the correct rating 3 Insert new fuses 100 240 V Line fuse 2 x T2 0AH250V 4 Now put the line fuse holder 0 on again 5 Restore the power supply 6 Switch the device on and ensure that the start screen appears 8 Mantenimiento 8 1 Cambio de fusibles 1 Desconecte el aparato y desenchúfelo de la ...

Страница 43: ...e insufǬation tube for visible contamination Visible contamination is an indication that reprocessing has not been carried out or has been carried out incorrectly Reprocess the reusable insufǬation tube 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 Employer s Liabili...

Страница 44: ...RL STORZ Instruments can be downloaded or requested by visiting www karlstorz com 8 2 1 Reprocessing of the ENDOFLATOR 40 3 WARNING Always disconnect the device from the mains before cleaning 3 WARNING Liquid must not be allowed to enter the housing under any circumstances Manual wipe down disinfection of device and supply tube Wipe clean the exterior surfaces of the medical device with a disposab...

Страница 45: ...to cleaning and disinfection 8 2 3 1 Preparation for cleaning and disinfection The reusable insufflation tube must be kept moist for transportation to the reprocessing station in order to prevent contaminations from drying on or reduce this as far as possible 8 2 3 2 Manual precleaning Immersion in cold water for 5 minutes To dissolve dried organic residues immerse the reusable insufflation tube i...

Страница 46: ...ted access are covered and no air bubbles are present After the necessary exposure time clean the instrument mechanically using a brush or sponge Finally it must be rinsed with cold water to ensure neutralization 8 2 3 4 Manual disinfection The reusable insufflation tube must be completely immersed in a disinfectant solution Through disassembling the instrument and filling the lumina in a targeted...

Страница 47: ...nufacturer of the device Connecting In order to guarantee effective machine cleaning and disinfection connect the LUER Lock to the washer and disinfector using the LUER connector provided Place the reusable insufflation tube on the rinsing lance in order to ensure that it is rinsed out completely In addition put the plastic connector with the tube adapter side to the top on the rinsing lance 1 NOT...

Страница 48: ...The integrity of the reusable insufflation tube can be tested in the following way Attach a syringe to one end of the tube and kink the other end Place the insufflation tube in completely demineralized water or microbiologically pure sterile water Force air into the insufflation tube using the syringe If any bubbles appear in the water while forcing air through the reusable insufflation tube the t...

Страница 49: ...quirements and in consultation with the device manufacturers The following sterilization method has been validated and approved by KARL STORZ for this medical device Steam sterilization in the fractionated prevacuum procedure The medical device must be sterilized in its fully assembled state using the fractionated prevacuum procedure DIN EN ISO 17665 1 at 134 137 C with a minimum exposure time of ...

Страница 50: ...año controles de seguridad veriǫcacio nes repetitivas conforme a la CEI 62353 en este aparato y protocolizar dichos controles Inspección visual 1 Compruebe el aparato y los accesorios en cuanto a deterioros mecánicos que puedan menoscabar el funcionamiento 2 Compruebe la legibilidad de los rótulos rele vantes para la seguridad Mediciones eléctricas Control de los fusibles del aparato Medición de l...

Страница 51: ...ontroles de seguridad las veriǫcaciones repetitivas puede consultarlas en la versión vigente del manual de servicio correspondiente 8 4 Reparaciones 3 CUIDADO Los equipos averia dos sólo deberán ser reparados por KARL STORZ o por personas autorizadas por KARL STORZ y utilizando única mente piezas de repuesto originales de KARL STORZ 8 5 Gestión de desecho Este aparato está identificado conforme a ...

Страница 52: ...al competente de KARL STORZ o bien a los distribuidores autorizados 8 7 Observaciones importantes Con el fin de prevenir infecciones rechazamos estrictamente la recepción de envíos de productos sanitarios contaminados Los productos sanitarios han de ser descontaminados directamente in situ con el fin de evitar infecciones aerógenas o por contacto entre el personal Nos reservamos el derecho de devo...

Страница 53: ...nd the device has been used in accordance with its operating instructions at all times 8 9 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 ...

Страница 54: ...er priority or a low priority information signal is suppressed for as long as there is a signal with a higher priority If there are several signal conditions of the same priority only the condition which was recognized last will be signalized i e the previous signal is overwritten 9 1 1 Visual signals Signals are displayed inversely blue font on a white background compared to normal displays and d...

Страница 55: ...tched on or off in the Device settings menu The acoustic signal can however only be switched off temporarily by the user When the line voltage is switched on the setting is always Audio On Information signal general The pitch is modulated by 2 Hz with a modulation frequency of 1 5 Hz Five different harmonics are generated In the case of messages which are related to the Safe State the signal seque...

Страница 56: ...res 20 bares suena un gong doble además de emitirse los avisos visuales des critos en el apartado Señalización óptica En este caso se trata de una secuencia agrupada de sonidos Su duración es de 1 5 segundos Al alcanzarse un valor inferior a la presión de ali mentación mínima se emite una señal de informa ción tanto en caso de alimentación a alta presión como en caso de alimentación a baja presión...

Страница 57: ...tacto con el Servicio Técnico Causas posibles Avería del aparato Acción Apague y vuelva a encender el aparato Si el men saje de advertencia persiste incluso después de efectuarse un reinicio póngase en contacto con el Servicio Técnico Antes de ello abra System Log Registro del sistema en Settings Ajustes y anote los campos ID Word1 Word2 y el texto informativo de las últimas 5 entradas Descripción...

Страница 58: ...ada dado que la resistencia del instru mento es demasiado alta y al mismo tiempo se produce una salida de gas fuera de la cavidad En función de las características del instrumento y de la fuga los valores actuales de presión y de flujo se situarán por debajo de los valores nominales 3 a Compruebe las conexiones de enchufe de los accesorios y la estanqueidad del trocar En caso de haberse superado l...

Страница 59: ...nsuflación max máx 30 mmHg Betriebsart High Flow High Flow mode Modo de servicio High Flow Intrakavitärer Druck Intracavitary pressure Presión intracavitaria 1 30 mmHg Auflösung resoluti on resolución 1 mmHg Flow Flow Flujo 1 40 l min Auflösung resolution resolución 1 l min Insufflationsdruck Insufflation pressure Presión de insuflación max máx 50 mmHg Abmessungen B x H x T Dimensions W x H x D Di...

Страница 60: ...ocks Applied part type CF 4 Type of IP protection IP21 According to IEC 60601 1 2 FCC B Observe the information on electromagnetic compatibility in chapter 11 pages 56 69 9 3 2 Directive compliance for UI400 According to the Medical Device Directive MDD This medical product belongs to Class IIb This medical product bears the CE mark in accordance with the Medical Device Directive MDD 93 42 EEC 1 N...

Страница 61: ... by the manufacturer Supply of such technical documentation relating to the device shall not be construed as constituting manufacturer s authorization of user s personnel regardless of their level of technical training to open or repair the device Explicitly exempted herefrom are those maintenance and repair operations described in this manual 1 NOTE We reserve the right to make engineering modiǫc...

Страница 62: ...022 Same length 102 cm 20400028 High pressure tube American connector American connector length 102 cm 20400025 Same length 55 cm 20400029 High pressure tube American connector ISO connector length 102 cm 20400222 CO2 bottle 1 l empty with German connector 26400090 CO2 bottle 1 l empty with PIN Index connector 26400091 Low pressure tube for the central CO2 gas supply length 150 cm UI001 Same lengt...

Страница 63: ...ngth 10 cm 26120 J Same length 12 cm 26120 JL Same length 7 cm 26120 JK Same length 15 cm for creating pneumo peritonea by means of DOUGLAS puncture with adipose patients 26120 JF Bottle holder for the KARL STORZ CO2 bottle UI005 Leakage tester 13242 XL Artículo N º de pedido Tubo ƃexible de insuƃación esterilizable 2 5 m de longitud diam inte 9 mm UI004 Filtro para gas desechable estéril envase d...

Страница 64: ...f the equipment and systems which generate or use RF energy only for their internal functioning 1 NOTE The tables and guidelines that are included in this appendix provide information to the customer or user that is essential in determining the suitability of the device or system for the electromagnetic environment of use and in managing the electromagnetic environment of use to permit the device ...

Страница 65: ...e of portable and mobile RF equipment may have an impact on this or other pieces of medical equipment 3 WARNING The use of accessories transducers and cables other than those speciǫed in the KARL STORZ instruction manual may result in increased emissions or decreased immunity of the device The accessories transducers and cables listed below have been shown to comply with the requirements of IEC 60...

Страница 66: ... HF Aussendungen nach CISPR 11 Klasse B Der ENDOFLATOR 40 Modell UI400 ist für den Gebrauch in allen Einrichtungen einschließlich Wohnbereichen und solchen bestimmt die unmittelbar an ein öffentliches Versorgungsnetz angeschlossen sind das auch Gebäude versorgt die für Wohnzwecke genutzt werden Aussendung von Oberschwin gungen nach IEC 61000 3 2 Klasse A Aussendungen von Spannungs schwankungen Fli...

Страница 67: ...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 25 Period...

Страница 68: ...ger als der Übereinstimmungspegel seinb 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 Reƃexionen der Gebäude Gegenstände und Menschen beeinƃusst a ...

Страница 69: ...Hz 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 Ang...

Страница 70: ...environment guidance RF emissions CISPR 11 Group 1 The ENDOFLATOR 40 model UI400 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 CISPR 11 Class B The ENDOFLATOR 40 model UI400 is suitable for use in all establishments including domestic establishments and those directly connec...

Страница 71: ...ains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines 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 UT 95 dip in UT for 5 seconds 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 ...

Страница 72: ... 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 apply in all situations Electromagnetic propagation is affected by absorption and reƃection by structure...

Страница 73: ...f 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 the equation applicable to the frequency of the transmitter where P is the maximum output power rating of...

Страница 74: ...misiones de RF Norma CISPR 11 Grupo 1 El ENDOFLATOR 40 modelo UI400 usa energía de RF sólo 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 Norma CISPR 11 Clase B El ENDOFLATOR 40 modelo UI400 es adecuado para usarse en todos los establecimientos incluyendo los esta...

Страница 75: ...ad de la red de alimentación debería ser la de un entorno comercial típico o la de un hospital Caídas de tensión interrupciones y variaciones de tensión en las líneas de entrada de alimentación Norma CEI 61000 4 11 5 UT caída 95 en UT para 1 2 ciclo 40 UT caída 60 en UT para 5 ciclos 70 UT caída 30 en UT para 25 ciclos 5 UT caída 95 en UT para 5 segundos 5 UT caída 95 en UT para 1 2 ciclo 40 UT ca...

Страница 76: ... por debajo del nivel de conformidad en cada rango de frecuenciab La interferencia puede ocurrir 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 aplicar en todas las situaciones La propagación electromagnética es afectada por la absorción y reƃexión desde estructuras objetos y per...

Страница 77: ...smisor 150 kHz a 80 MHz C 80 MHz a 800 MHz C 800 MHz a 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 asignados con una potencia máxima de salida no listados arriba la distancia de separación recomendada d en metros m se puede determinar usando la ecuación aplicable a la frecuencia del transmisor donde P es la máxima potencia de sal...

Страница 78: ...1 E Mail info ro karlstorz com KARL STORZ Endoskope Greece 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 En...

Страница 79: ......

Страница 80: ...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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