Karl Storz UP 501 S-PILOT, Instruction Manual

Page 1: ...GEBRAUCHSANWEISUNG UP 501 S PILOT Schlauchquetschventil INSTRUCTION MANUAL UP 501 S PILOT Tube Squeeze Valve MANUAL DE INSTRUCCIONES UP 501 Válvula de compresión S PILOT para tubo flexible ...

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Page 3: ...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 installation connection and operation of the tube squeeze valve S PILOT UP 501 All of the necessary details and actions are clearly explained Please read these instructions carefully Keep this manual in a con...

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

Page 5: ...en off closed 3 Tube squeeze valve 4 Connection socket for footswitch 20 0141 30 or control cable 27 6100 70 or 20 7010 70 for connecting the UNIDRIVE S III or CALCUSON 5 Connection socket for 3 5 mm connecting cable UP 004 or UP 005 for optional remote control of an HF surgical unit 6 Slot for SD memory card for software updates 7 SCB connectors 8 Power cord socket 9 Potential equalization connec...

Page 6: ...otencial Control remoto Corriente alterna Control de la contaminación cau sada por productos de información electrónica directiva RoHS china Este aparato está identificado con forme a la directiva europea referida a aparatos eléctricos y electrónicos viejos waste electrical and electro nic equipment o WEEE Fabricante 4 2 Symbole auf Label und Verpackung des Gerätes Die Bedeutung der auf Label oder...

Page 7: ...e if package is 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 Keep away from sunlight Sterilized with ethylene oxide Use by date Batch code Fabricante Número de catálogo No reutilizar No estéril Símbolo CE Conformidad con las normas Según CEI 60601 1 Grado de protección contra descarga...

Page 8: ...z LAP Example of a workstation LAP Ejemplo de puesto de trabajo LAP Exemplarischer Arbeitsplatz URO Example of a workstation URO Ejemplo de puesto de trabajo URO VIII Imágenes del equipo Images of the equipment Geräteabbildungen ...

Page 9: ...itions of use 13 6 5 1 Use 13 6 5 2 Other intended conditions 13 6 6 Safety precautions at the installation site 14 6 7 Safety precautions when operating the device 15 6 8 Safety features 15 6 8 1 Self test 15 6 8 2 Motor current monitoring 15 7 Installation and operating instructions 16 7 1 Unpacking the equipment 16 7 2 Basic equipment 16 7 3 Installing and connecting the device 16 7 3 1 Connect...

Page 10: ...peat inspections as per IEC 62353 27 8 3 Servicing and repair 28 8 4 Disposal 28 8 5 Repair program 29 8 6 Important information 29 8 7 Limitation of liability 30 8 8 Warranty 30 9 Technical description 31 9 1 Acoustic signals 31 9 2 Troubleshooting 32 9 3 Technical data 34 9 3 1 Standard compliance 35 9 3 2 Directive compliance 35 9 4 Technical documentation 36 10 Spare parts recommended accessor...

Page 11: ...alve can also be opened and closed using the button 2 on the S PILOT e g by unsterile OR staff When operated indirectly the tube squeeze valve is activated via a device connected to the S PILOT The devices are connected to each other either via the S PILOT footswitch socket the KARL STORZ SCB interface or via a connecting cable UP 004 UP 005 a Automatic smoke evacuation using HF surgical unit The ...

Page 12: ...following table Device Accessories KARL STORZ AUTOCON III 400 Connecting cable UP 004 KARL STORZ AUTOCON II 400 SCB connecting cable ERBE Vio 300D Set for SCB ERBE Vio Interface 20 0900 13 COVIDIEN Force Triad Connecting cable UP 005 COVIDIEN Valleylab Force FX Connecting cable UP 005 ConMed System 5000 Connecting cable UP 004 ConMed System 2450 Connecting cable UP 004 KLS Martin maxium ME402 Set ...

Page 13: ...TORZ urologic morcellator or hysteroscopic shaver is not authorized for users inside the U S c Suctioning fluid when using with the CALCUSON ultrasonic generator The signal of a two stage single pedal footswitch connected to the CALCUSON is looped through the control cable 20 7010 70 to the S PILOT If the surgeon activates the first stage of the footswitch the valve on the S PILOT opens so that fl...

Page 14: ...e full text of the GPL is available here http www freertos org license txt The text of the exception is available on FreeRTOS official website http www FreeRTOS org License and Warranty Page The exceptions permits the source code of applications that use FreeRTOS soley through the API published on this WEB site to remain closed source thus permitting the use of FreeRTOS in commercial applications ...

Page 15: ...accompanied 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...

Page 16: ...01 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 electric shock this equipment must only be connected to a supply mains with protective earth 3 WARNING No responsibility for the safe operation of the device can be accepted i...

Page 17: ...ntrollable suction 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 instruct...

Page 18: ...ons liquid enters the device sufǫcient time should be planned for evaporation this also applies for the formation of condensation 3 WARNING The device may only be operated at the voltage stated on the rating plate Instrucciones de seguridad Indicaciones de alarma y advertencia Safety instructions Warnings and cautions 3 CUIDADO Evite a toda costa la inǫltra ción de líquidos en el interior de la ca...

Page 19: ...n for successful operation Use of the device in fields other than those indicated above is not allowed for safety reasons The S PILOT may only be operated with tubing sets and accessories which have been designated as suitable for the device by KARL STORZ 3 WARNING No responsibility for the safe operation of the device can be accepted if any tubing systems other than those speciǫed are used 3 WARN...

Page 20: ...l customer service 6 2 2 Contraindications No contraindications relating directly to the use of this product are currently known The use of this device is contraindicated if in the opinion of an experienced physician the patient s health is endangered through its use 6 3 User qualification The S PILOT may only be used by physicians and medical assistants who have a corresponding specialized qualif...

Page 21: ...e instruction manual 6 5 2 Other intended conditions Frequency of use one or more times a day Length of use from a few minutes to several hours a day Place of installation positioning on a level vibration free surface Mobility can be moved if positioned on a cart Combination can be used on the patient at the same time as other equipment required for the operations Control can be controlled via the...

Page 22: ...nesthetic gases are in use 3 WARNING The device must not be used in oxygenated environments This also applies for easily combustible and explosive chemicals e g skin disinfectants and fast acting surface disinfectants 3 WARNING The device is equipped with a connector for attaching a ground line It should be connected up in accordance with the applicable national regulations 3 WARNING The use of ad...

Page 23: ...h time the device is switched on If the test is negative this is indicated by the blinking of the status LED and an acoustic alarm Its intended use is no longer possible The following components have been tested Functionality of the tube squeeze valve 6 8 2 Motor current monitoring The control of the motor drive of the S PILOT tube squeeze valve contains a temperature and current monitor which swi...

Page 24: ... equipment KARL STORZ Set no UP 501 S1 1 S PILOT UP 501 1 Power cord 400 A 5 Tubing sets for the suctioning of smoke gas and fluid for single use sterile 031447 03 1 SCB connecting cable 20 0901 70 length 100 cm 1 One pedal footswitch 20 0141 30 1 Instruction manual Montaje e instrucciones operativas Installation and operating instructions 7 Montaje e instrucciones operativas 7 1 Desembalaje Extra...

Page 25: ...operated at the voltage stated on the rating plate 4 Push the power cord into the power socket as far as it will go The operating indicator light status LED of the On Off switch lights up orange standby 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 cord delivered b...

Page 26: ...el cable de conexión con el punto rojo en el conector del interruptor de pedal 7 3 4 Combining the HF device with the S PILOT in the OR1 system via the KARL STORZ SCB automatic smoke evacuation 1 NOTE To prevent the SCB connecting 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 in...

Page 27: ...terface device SCB ERBE Vio using the ECB connecting cable 20 0913 70 with the ERBE Vio 300D ERBE Vio 300D Para conectar el aparato de AF ERBE a la S PILOT se necesita el aparato de interfaz KARL STORZ SCB ERBE Vio 20 0900 13 1 Empalme las conexiones SCB 7 de la S PILOT y el aparato de interfaz SCB ERBE Vio 20 0913 32 por medio del cable de conexión SCB 20 0901 70 véase la figura en la sección 7 3...

Page 28: ...OCON III 400 HF device using the connecting cable UP 004 dia 3 5 mm ConMed System 2450 and 5000 Connect the remote control connection 5 of the S PILOT with the corresponding connection of the HF device using the connecting cable UP 004 dia 3 5 mm COVIDIEN Force Triad and Valleylab Force FX Connect the remote control connection 5 of the S PILOT dia 3 5 mm with the corresponding connection of the HF...

Page 29: ...see Section 10 2 ensures optimal functioning of the S PILOT UP 501 3 WARNING No responsibility for the safe operation of the device can be accepted if any tubing systems other than those speciǫed are used 3 WARNING When inserting the tubing set it must be ensured that the tube is completely inserted 3 WARNING Before you start the intervention make sure that the tubing set is not leaking or kinked ...

Page 30: ...hich is not required is closed see Fig D 1 NOTE To prevent the cavity from collapsing the suction Ǭow can be adjusted at any time via the roller clamp attached close to the patient 1 NOTE Fluid and smoke gas can be suctioned simultaneously via the Y adaptor 5 Suction tube 031447 01 Connect the other end of the suction tube to the trocar via LUER lock see Fig F Suction tube 031457 01 Connect the ot...

Page 31: ...nect to the power supply Connect the control cable 27 6100 70 between the UNIDRIVE S III and the S PILOT Following the boot sequence actuate the first stage of the footswitch The tube squeeze valve must be open as long as the activation signal is present S PILOT with CALCUSON CALCUSON Connect to the power supply Connect the footswitch 20 0142 30 to the footswitch socket Connect the ultrasonic tran...

Page 32: ...N III 400 Connect to the power supply Switch on the device Wait until the boot sequence is complete S PILOT Connect to the power supply Connect the remote control connection 5 of the S PILOT with the corresponding connection of the AUTOCON III 400 HF device using the connecting cable UP 004 dia 3 5 mm Following the boot sequence actuate the HF device cutting coagulation The tube squeeze valve must...

Page 33: ...ability Insurance Association and equivalent organizations striving to ensure personal safety must be observed 3 WARNING When preparing and using the solutions follow the chemical manufacturer s speciǫcations paying close attention to proper concentration exposure time and service life Incorrect concentration may result in damage Bear in mind the microbiological range of action of the chemicals us...

Page 34: ... agents must not be used The chemical manufacturer s specifications concerning material compatibility must be observed At the end of the necessary exposure time for the disinfectant as specified by the manufacturer wipe the surface with a dry and low lint cloth 8 1 2 Reprocessing of suction tube set for single use sterile 3 WARNING Suction tube sets for single use must not be reprocessed Sterile d...

Page 35: ...ccidentes o intervalos de control técnico de aparatos médicos un técnico con formación electrotécnica especializada ha de llevar a cabo una vez al 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 funcionamie...

Page 36: ...técnico cualiǫcado 8 3 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 4 Gestión de desecho Este aparato está identificado conforme a la directiva europea referida a aparatos eléctricos y electrónicos viejos Waste Electrical and Electronic Equipme...

Page 37: ...sal competente de KARL STORZ o bien a los distribuidores autorizados 8 6 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 dev...

Page 38: ...nd the device has been used in accordance with its operating instructions at all times 8 8 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 ...

Page 39: ...ical description 9 Technical description 9 1 Acoustic signals Information signal general Amplitude Time c 100 ms e c e 100 ms Availability signal Ready This signal is issued following a successful self test Amplitude Time c 100 ms e g h 9 Descripción técnica 9 1 Señales acústicas Señal de información general Amplitude Time c 100 ms e c e 100 ms Señal de estado dispuesto ready Esta señal se emite d...

Page 40: ...nadequate suction Possible causes 1 Leakage in tubing system 2 Tubing system blocked 3 Suction container full Action 1 Check all suction lines and replace any exhibiting evidence of leakage Check the seating of the sealing cap 2 Remove all blockages and replace any exhibiting evidence of leakage 3 Empty or replace suction container Symptom Error during Power on Test Chap 6 8 1 System error Status ...

Page 41: ...ibung Fehlersuchliste Descripción técnica Localización de errores Technical description Troubleshooting Symptom SCB connection lost during operation Acoustic information signal every 10 s Action Check SCB connection Descripción del error Pérdida de la conexión SCB durante el servicio Señal acústica de información cada 10 s Acción Compruebe la conexión SCB ...

Page 42: ...ftfeuchtigkeit rel Feuchte nicht kondensierend Humidity rel humidity non condensing Humedad del aire humedad relativa sin condensación 15 85 Temperatur Temperature Temperatura 10 40 C Max Betriebshöhe Max operating altitude Altura máxima de servicio 3000 m Lager Transportbedingungen Storage transport conditions Condiciones de almacenamiento transporte Luftfeuchtigkeit rel Feuchte nicht kondensiere...

Page 43: ... Degree of protection against electric shocks 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 38 51 9 3 2 Directive compliance for UP 501 According to the Medical Device Directive MDD This medical product belongs to Class I This medical product bears the CE mark in accordance with the Me...

Page 44: ...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 modiǫca...

Page 45: ... de mando cable de conexión entre el UNIDRIVE S III CALCUSON y la S PILOT longitud 100 cm 20 7010 70 Set de tubos flexibles desechables para aspiración de humos gas y succión de líquidos Esterilizado envase de 10 unidades 031447 10 Set de tubos flexibles desechables para aspiración esterilizado envase de 10 unidades 031457 10 Bolsa de succión VACUsafe de 2 l con filtro desechable Código de color v...

Page 46: ...nd systems which generate or use RF energy only for their internal functioning 1 NOTE The tables and guidelines that are included in this section 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 or system to perfo...

Page 47: ... Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the S PILOT UP 501 including cables speciǫed by the manufacturer Otherwise degradation of the performance of this equipment could result 3 WARNING Use of accessories transducers and cables other than those speciǫed or provided by the ...

Page 48: ... 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 Flicker nach IEC 61000 3 3 Stimmt überein Leitungen mit denen die Übereinstimmung mit der IEC 60601 1 2 nachgewiesen wurde Typ Schirm Länge m Ferrite Verwendung PA Nein 3 Nein Potentialausgleich SCB Kabel Ja 1 Nein Verbindung zum SCB...

Page 49: ...annung 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 Perioden 5 ...

Page 50: ...s 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 beeinflusst a Die...

Page 51: ...0 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 Angabe de...

Page 52: ...UP 501 is intended for use in the electromagnetic environment speciƂed below The customer or user of the S PILOT model UP 501 should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The S PILOT model UP 501 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likel...

Page 53: ...ns 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 sec 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...

Page 54: ...tromagnetic site surveya should be less than the compliance level in each frequency range b 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 structures objects and people ...

Page 55: ...Hz 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 the transmitter in...

Page 56: ...on Tabla 1 Guía y declaración del fabricante emisiones electromagnéticas La válvula S PILOT modelo UP 501 está prevista para el uso en un entorno electromagnético especiƂcado debajo El cliente o el usuario de la válvula S PILOT modelo UP 501 debería asegurarse de que se use en dicho entorno Ensayo de emisiones Conformidad Entorno electromagnético Guía Emisiones de RF Norma CISPR 11 Grupo 1 La válv...

Page 57: ...idad 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 ...

Page 58: ...star 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 reflexión desde estructuras objetos ...

Page 59: ...isor 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 salid...

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Page 62: ...rz 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 Endoskopy WOSTOK Derbenyev...

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Page 64: ...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 ...