Karl Storz 203210 20, Instruction Manual

Page 1: ...DUOMAT DUOMAT DUOMAT 203210 20 203210 20 203210 20 ...

Page 2: ......

Page 3: ...Gebrauchsanweisung Instruction Manual Manual de instrucciones DUOMAT DUOMAT DUOMAT 203210 20 203210 20 203210 20 ...

Page 4: ...ig durch bewahren Sie sie zum etwaigen Nachlesen in der mitgelieferten Schutzhülle an gut sichtbarer Stelle beim Gerät auf This instruction manual is intended to serve as an aid in the proper setup installation and operation of the DUOMAT All essential details of the equipment and all actions required on your part are clearly presented and explained We thus ask that you read this manual carefully ...

Page 5: ...III 햷 햸 햶 햵 햴 햳 햹 햲 햾 햽 햻 햺 ...

Page 6: ... suction line to the instrument 햹 Drawer for abridged instructions 햺 Power supply cord receptacle 햻 Power fuse holder 햽 Potential equalization connector 햾 Bottle stand 햲 Interruptor de la red 햳 Conexión de irrigación del equipo 햴 Conexión de succión del equipo 햵 Conexión para el tubo flexible de succión al equipo 햶 Conexión para el tubo flexible de irrigación al equipo 햷 Conexión para el tubo flex...

Page 7: ...ittelbaren Umgebung des Gerätes besteht Explosionsgefahr Achtung Nicht öffnen Gefahr eines elektrischen Schlages Lassen Sie Servicearbeiten nur von qualifiziertem Personal durchführen Danger Risk of explosion if used in the presence of flammable anesthetics Caution To reduce the risk of electrical shock do not remove cover Refer servicing to qualified service personnel Atención No abrir Peligro de...

Page 8: ...VI ...

Page 9: ...ting up the unit 8 Connecting suction tubing 10 Connecting irrigation tubing 11 Operating the unit 12 Testing the unit for proper operation 12 Maintenance 13 Fuse replacement 13 Cleaning disinfection and sterilization 14 Preliminary cleaning of reusable tubing 15 Cleaning preparation 15 Manual cleaning of suction bottle 16 Manual preparation of reusable tubing 16 Machine preparation of reusable tu...

Page 10: ...e parts recommended accessories 26 Spare parts list 26 Accessories 27 KARL STORZ Irrigation Suction and Coagulation System 28 Appendix 29 Cleaning agents and disinfectants 29 Electromagnetic Compatibility EMC Information 31 Warranty card Subsidiaries Descripciones técnicas 22 Localización de errores 22 Ficha técnica 23 Documentación técnica 24 Esquema de distribución general 25 Piezas de repuesto ...

Page 11: ...junction with KARL STORZ fiberscopes Irrigation and suction are performed at preset constant values thus requiring minimal operating effort Suction irrigation tubes with valves can be used to regulate irrigation and suction in laparoscopic applications Descripción del aparato La DUOMAT es una bomba de succión irrigación de grandes prestaciones especialmente adecuada para su utilización durante int...

Page 12: ...enten Ihres Personals sowie Ihrer eigenen Person zu vermeiden 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 Caution A Caution indicates that parti cular service procedures or precautions must be followed to avoid possible damage to the product Warning Read this instruction m...

Page 13: ...ical plug and cord Do not use if inspection reveals damage Warning Always unplug the unit before doing any maintenance work on it e g cleaning Warning To avoid the risk of electrical shock do not open the unit Refer servicing to qualified personnel Removal of covers by unauthorized personnel will void the equipment s warranty Caution The DUOMAT may only be operated with tubing sets and accessories...

Page 14: ...esponsible for the proper disposal of this unit Before using the unit on the patient it is imperative that you be acquainted with how the unit operates and is controlled Intended use The DUOMAT is a suction irrigation pump for suction and irrigation in endoscopic interventions It is applied either via special suction irrigation instruments or in conjunction with fiberscopes Use of the unit in fiel...

Page 15: ...asily combustible and explosive inhalation anesthetics or mixtures thereof the unit must not be operated inside the hazard zone shown in the diagram This also applies to highly combustible and potentially explosive chemicals e g skin disinfectants and fast acting surface disinfectants Safety precautions when operating the unit It is the user s responsibility to make sure the unit is safe and opera...

Page 16: ...materials for later use these can come in handy if the unit has to be transported Basic equipment 1 DUOMAT 1 Power cord 1 Instruction manual 1 Plastic wallet for instruction manual 1 Operator s quick reference guide self adhesive Installing and connecting up the unit Note The DUOMAT may only be used in medical rooms in which the electrical equipment has been installed in accordance with applicable...

Page 17: ...sed screw it onto the side of the unit Remove power fuse holder 햻 and withdraw voltage preselection module Insert voltage preselection module into power fuse holder so that the mains voltage indicated in the window at the back of the power fuse holder agrees with the local voltage supply Connect power cord Insert power cord into power cord receptacle 햺 as far as it will go EI equipo está provisto ...

Page 18: ...in that the cap of the suction line bottle is firmly seated since adequate irrigation will not otherwise be achieved Insert the irrigation bottle into its holder Remove the cap of the irrigation bottle attach the sterile bottle cap and secure it with the sealing clip Connecting suction tubing Attach the LUER lock connection of the vacuum tube to the unit s connector 햴 Screw the bacterial filter in...

Page 19: ... the LUER lock fitting of the short tube to the short nozzle 햶 of the bottle cap Connect the other end of the tube to the unit s fitting 햳 Connect the long angled connecting piece of the bottle cap 햷 to the suction irrigation tube or the suction irrigation handle by means of the second silicone tube when using sterile piercing bottles Introduce the puncture cannula into the irrigation solution bot...

Page 20: ... for suction and irrigation Suction and irrigation can now be initiated using the valves on the suction irrigation tube or on the suction irrigation handle Testing the unit for proper operation Note The unit must be checked to ensure safe functioning and proper condition prior to use on patients Remove the tube coming from fitting 햳 from bottle cap 햶 Switch on the unit Place a finger on the end of...

Page 21: ... power fuse holder 햻 with a screw driver or other tool Caution Only use fuses of the correct rating Insert new fuses of the appropriate rating 100 120 VAC 230 240 VAC Power fuse 2 x T 0 5 A L 2 x T 0 2 A L Refit the power fuse holder 햻 Reconnect the power cord Test the unit for proper operation Cambio de fusibles Desconecte el equipo y desenchufe la conexión a la red Desprenda la abrazadera de seg...

Page 22: ...lized using validated preparation procedures before initial use and subsequent reuse Warning For all cleaning and disinfec tion procedures on contaminated instru ments tubing sets the guidelines of the Employer s Liability Insurance Association and equivalent organizations must be observed Warning Prior to the sterilization of reusable tubing particularly in cases of manual preparation it must be ...

Page 23: ...olutions follow the manufacturer s instructions paying close attention to proper dilution and working times Prolonged immersion can lead to material changes Cleaning preparation Warning For all cleaning and disinfec tion procedures on contaminated instru ments the local guidelines of the Employer s Liability Insurance Asso ciation and equivalent organizations must be observed Manual cleaning sucti...

Page 24: ...tion of exposure 4 Cleaning brushes must be cleaned and disinfected immediately 5 Remove the tubing after the exposure time and rinse with microbiologically pure sterile water Ensure that all chemical residue in and on the tubing is removed 6 Dry the tubing with sterile compressed air 7 After preparation inspect the tubes for cleanliness and damage If soiling is still visible the preparation proce...

Page 25: ...leakage tester Sterilization The suction fluid collection bottle and lid includ ing the overflow protection unit can be either steam sterilized or gas sterilized We recommend steam sterilizing the reusable tubing before use at 134 C 3 C using the fractionated prevacuum procedure Warning Successful sterilization is only possible on clean disinfected surfaces Warning The recommended sterilization pa...

Page 26: ...ionated prevacuum procedure consists of four phases Conditioning phase The conditioning phase removes air from the chamber by pulling a vacuum up to four times Steam is then blown in Sterilization phase Sterilization takes place at a temperature of 134 C 3 C and a pressure absolute of 300 kpa 3 bar over a period of 5 minutes minimum time Evacuation phase The steam is released Drying phase Drying t...

Page 27: ...escribed in different countries we recommend a functional or safety test of the unit at least once a year For detailed instructions please refer to the version of the Service Manual currently valid catalog number SV 3403 English version Note To ensure safe operation of the system you should perform the following procedures every 12 months 1 Check leakage current from chassis 100 μA 2 Check ground ...

Page 28: ... aparatos o instrumentos cuya reparación haya sido realiza da por terceros no autorizados Repair program Usually to bridge the repair period you will receive a unit on loan which you then return to KARL STORZ as soon as you receive the repaired unit In Germany you can refer repairs direct to KARL STORZ GmbH Co KG Abt Reparaturservice Dr Karl Storz Str 34 78532 Tuttlingen In other countries please ...

Page 29: ...be proven to have defects in material or workmanship In so doing we cannot accept to bear the cost of transportation or the risk of shipment The warranty referred to in our Standard Conditions of Business shall apply Please fill out the attached warranty card on the last page and return it as soon as possible to KARL STORZ GmbH Co KG Postfach 230 78503 Tuttlingen Germany Note The unit must always ...

Page 30: ... Possible causes Leakage occurring in suction line Remedy Check all suction lines and replace any showing signs of leakage Check the seating of the sealing cap Symptom No suction Possible causes Float of overflow protection unit blocking suction inlet Suggested remedy Check the fluid level in the vessel and empty if required Clean the floats and check them for freedom of movement Symptom Too littl...

Page 31: ... las indicaciones sobre compatibilidad electromagnética en el Anexo págs 31 42 Conformidad con la directiva p 20 3210 20 Según Medical Device Directive MDD Producto médico del grupo II b Este producto médico está provisto del símbolo CE según MDD 93 42 CEE Nota El número de identificación que sigue al símbolo CE designa el organismo notificado competente Technische Beschreibung Technical descripti...

Page 32: ...nel regardless of their levels of technical training to open or repair the instrument Explicitly exempted herefrom are those mainte nance and repair operations described in this manual Documentación técnica EI personal calificado del usuario que haya sido debidamente autorizado por el fabricante para reparar los componentes del equipo que por el fabricante sean calificados de reparables podrá pedi...

Page 33: ...eneral circuit diagram Esquema de distribución general 25 Technische Beschreibung Technical description Descripciones técnicas KG001 Q001 TR001 LF001 M001 IRRIGATION SUCTION 14 VDC F001 240 VAC 230 VAC 120 VAC 110 VAC N F002 ...

Page 34: ... für Absaugung Silicone tubing set for suction Set de tubos flexibles 20 3000 42 de silicona para succión Silikon Schlauchset für Spülung Silicone tubing set for irrigation Set de tubos flexibles 20 3000 45 de silicona para irrigación Saug und Spülrohr Suction and irrigation tube Tubo de succión irrigación 26173 BN Netzsicherung T 0 5 A L 250 V Power fuse T 0 5 A L 250 V Fusible para la red T 0 5 ...

Page 35: ...ión 1500 ml 26 3100 38 Druckinfusionsmanschette 3000 ml Pressure cuff 3000 ml Brazalete de infusión a presión 3000 ml 26 3101 38 Punktionskanüle Puncture needle Aguja de punción para botella 26173 VG für Sterilwasserflasche 1 l for 1 l sterile water bottle de agua esterilizada 1 l Punktionskanüle Puncture needle Aguja de punción para botella 860015 B für Sterilwasserflasche 0 5 l for 0 5 l sterile...

Page 36: ...Z presenta un nuevo y prácti co instrumento combinado para aplicaciones lapa roscópicas La base del sistema es un manipula dor apto para autoclave con conexión para elec trodos y tubos de succión irrigación El conjunto del sistema es compacto de conformación ergo nómica y fácil de usar 28 Ersatzteile empfohlenes Zubehör Spare parts recommended accessories Piezas de repuesto accesorios recomendados...

Page 37: ...perficiales en superficies de aluminio también con revesti miento plásticos así como en conexiones solda das y menoscabar la durabilidad del instrumen tal En el caso de endoscopios flexibles única mente debe introducirse la vaina diagnóstica nunca el recubrimiento ni el mango Typ 1 Reiniger 2 Desinfektionsmittel 3 geeignet für Ultraschallbäder A nicht geeignet für flexible Endoskope gemäß Herstell...

Page 38: ...ientes productos para limpieza y desinfección mecánicas están autorizados en lo referente a compatibilidad de materiales 30 Anhang Reinigungs und Desinfektionsmittel Appendix Cleaning agents and disinfectants Anexo Productos de limpieza y desinfección Typ 1 Reiniger 2 Desinfektionsmittel 3 geeignet für Ultraschallbäder 4 Neutralisator 5 Klarspüler A nicht geeignet für flexible Endoskope gemäß Hers...

Page 39: ...al 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 and systems or non medical electrical equipment If this equipment does cause harmful interference with other devices the user is encouraged to t...

Page 40: ...ortátiles y móviles puede influir sobre los mismos o bien sobre otros equipos electromédicos 32 Tabelle 201 Leitlinien und Herstellererklärung Elektromagnetische Aussendungen DUOMAT Modell 203210 20 ist für den Betrieb in einer wie unten angegebenen Umgebung bestimmt Der Anwender des Gerätes sollte sicherstellen dass der DUOMAT Modell 203210 20 in einer derartigen Umgebung betrieben wird Störausse...

Page 41: ...ctromagnéticas La DUOMAT modelo 203210 20 está prevista para el uso en un entorno electromagnético especificado debajo El usuario del equipo se debería asegurar que la DUOMAT modelo 203210 20 se use en dicho entorno Ensayo de emisiones Conformidad Entorno electromagnético Guía Emisiones de RF Norma CISPR 11 Está conforme con el grupo 1 La DUOMAT modelo 203210 20 usa energía de RF sólo para su func...

Page 42: ...Gleichtaktspannung 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 UT 95 Einbruch der UT für 5 Sekunden Stimmt...

Page 43: ...ferential mode 2 kV common mode 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 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 Complies 5 UT 95 dip in UT for 0 5 cycle Complies 40 UT 60 di...

Page 44: ...e 1 kV en modo diferencia 2 kV en modo común La calidad 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...

Page 45: ...zen gemäß einer Untersuchung vor Ort a geringer als der Übereinstimmungspegel sein b In der Umgebung von Geräten die das folgende Bildzeichen tragen sind Störungen möglich Anmerkung 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 Feldstärke stationär...

Page 46: ...fixed RF transmitters as determined by an electromagnetic 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 Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection by structures objects and people a Field strengths fro...

Page 47: ...dio electromagnético del lugara deberían estar 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 Nota Estas directrices no se pueden aplicar en todas las situaciones La propagación electromagnética se afecta por la absorción y reflexión desde estructuras objetos y personas a Las intensidades de...

Page 48: ... bis 80 MHz P d 3 5 3 80 MHz bis 800 MHz P d 3 5 3 800 MHz bis 2 5 GHz P d 3 7 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 ...

Page 49: ...power of transmitter W 150 kHz to 80 MHz P d 3 5 3 80 MHz to 800 MHz P d 3 5 3 800 MHz to 2 5 GHz P d 3 7 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...

Page 50: ...e salida asignada al transmisor W 150 kHz a 80 MHz P d 3 5 3 80 MHz a 800 MHz P d 3 5 3 800 MHz a 2 5 GHz P d 3 7 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 de...

Page 51: ... 78503 Tuttlingen Germany For a period of two years after delivery to the end user we shall replace free of charge equipment that can be proven to have defects in material or workman ship In doing so we cannot accept to bear the cost of transportation or the risk of shipment The warranty referred to in our Standard Conditions of Business shall apply To be completed by the supplier importer Company...

Page 52: ...eräte Besitzer auszufüllen Absender Firmenstempel Anwendungsgebiet Geräte Typ Serien Nr Kauf Dat Unterschrift Datum Bitte ausreichend frankieren ANTWORTKARTE KARL STORZ GmbH Co KG Postfach 230 78503 Tuttlingen To be filled out by instrument owner Return address company stamp Field of application Type of instrument Serial no Purchase date Signature Date Please attach sufficient postage REPLY CARD K...

Page 53: ......

Page 54: ...rof Dr Anton Colorian nr 74 Sector 4 041393 Bukarest Romania Phone 40 0 31 4250800 Fax 40 0 31 4250801 E Mail office karlstorz ro TOV KARL STORZ Ukraine 18b Geroev Stallingrada avenu 04210 Kiev Ukraine Phone 380 44 42668 14 15 19 20 Fax 380 44 42668 14 OOO KARL STORZ Endoskopy WOSTOK Derbenyevskaya nab 7 building 4 115114 Moscow Russia Phone 7 495 983 02 40 Fax 7 495 983 02 41 E Mail kste wostok k...

Page 55: ......

Page 56: ...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 de Web www karlstorz com ...