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Storz ENDOMAT SELECT, Instruction Manual

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GEBRAUCHSANWEISUNG
UP 210

   

ENDOMAT

®

 SELECT

INSTRUCTION MANUAL
UP 210

   

ENDOMAT

®

 SELECT

MANUAL DE INSTRUCCIONES
UP 210

   

ENDOMAT

®

 SELECT

Summary of Contents for ENDOMAT SELECT

Page 1: ...GEBRAUCHSANWEISUNG UP 210 ENDOMAT SELECT INSTRUCTION MANUAL UP 210 ENDOMAT SELECT MANUAL DE INSTRUCCIONES UP 210 ENDOMAT SELECT...

Page 2: ...part are clearly presented and explained We thus ask that you read this manual carefully before proceeding to work with the equipment Insert this manual in its protective wallet and keep it available...

Page 3: ...Saugpumpe 1 2 Operation as suction pump from the irrigation liquid bag zum Instrument to the instrument vom Instrument Patient from instrument patient zum Auffangbeh lter to the collecting container...

Page 4: ...IV Images of the device Im genes del equipo Ger teabbildungen Q T YU I P W E R O...

Page 5: ...parametern 3 3 WARNUNG Der ENDOMAT SELECT ist nicht daf r vorgesehen mit anderen Ger ten ber die USB oder Ethernet Schnittstelle verbunden zu werden Diese Schnittstellen sind nur dem KARL STORZ Servic...

Page 6: ...g der auf Label oder Verpackung aufgedruckten Symbole k nnen Sie dem Beipackzettel Verpackungssymbole Mat Nr 96216316DF entnehmen Diesen k nnen Sie unter www karlstorz com herunterladen 3 2 Symbols on...

Page 7: ...by pump activated Start stop suction using the footswitch only available in the disciplines ART URO Boost pressure increase via button or footswitch in the example footswitch in 10 increments from 10...

Page 8: ...CV CLEARVISION CYST Cystoscopy DS Direct suction ENT Ear Nose Throat FC Flow controlled FESS Functional Endoscopic Sinus Surgery Gyn Gynecology HYS Hysteroscopy LAP Laparoscopy NEURO Neurosurgery PC...

Page 9: ...ation and function of the device 15 5 5 Patient profile 15 5 5 1 SURG URO ART ENT NEURO 15 5 5 2 GYN 15 5 6 Intended region of treatment on the patient 16 5 7 User profile of physician and assistants...

Page 10: ...12 Connecting the tubing cartridge for suction 31 6 12 1 Alternative A indirect suction suction for CALCUSON 31 6 12 2 Alternative B direct suction RES 33 6 13 Using the ENDOMAT SELECT as an irrigati...

Page 11: ...ification 50 8 1 1 Visual signaling 50 8 1 2 Acoustic signaling 50 8 1 3 Verification of the functioning of the alarm system 51 8 2 Information signals 51 8 2 1 Visual signaling 51 8 2 2 Acoustic info...

Page 12: ...at a later date see Fig 1 An Advanced software package UP 610 with extended setting options see pages 34 36 37 and 42 can also be purchased Additional functions BOOST With certain URO ARTHRO applicat...

Page 13: ...sistently deviates from the setpoint and emits an audible signal to inform the user The high safety standard of ENDOMAT SELECT is further enhanced by an electronic auto check system which tests the sy...

Page 14: ...on of this product To make the words stand out more clearly they are accompanied by a pictogram 3 3 WARNING Read this instruction for use thorough ly before putting the device into operation Read the...

Page 15: ...ls 75 80 mmHg zu verwenden WARNUNG Der Druck sollte so niedrig wie m glich gehalten werden um eine ausreichende intrauterine Dehnung zu erm glichen und die Kr fte zu reduzieren die den Eintritt von Fl...

Page 16: ...he anaphylaktoide Reaktionen w hrend der Hysteroskopie festgestellt Diese sollten wie jede allergische Reaktion behandelt werden WARNUNG Eileiterruptur nach Eileiterverstopfung Bei einer Verstopfung o...

Page 17: ...vice may only be connected to the devices listed below which have been shown to comply with the requirements of IEC 60601 1 CALCUSON UNIDRIVE S III UNIDRIVE S III ARTHRO WARNING Reel pump Do not touch...

Page 18: ...each surgical procedure to ensure that it is functioning correctly It should not be used if any damage is evident WARNING Follow the country specific regulations laws for the disposal of accessories W...

Page 19: ...Clinical Biomedical engineer or an EMC professional WARNING Additional devices which are connected to electrical medical devices must comply with the relevant IEC or ISO standards e g IEC 60950 for da...

Page 20: ...den Harnwegen bei diagnostischen und operativen endoskopischen urologischen Eingriffen eine Fl ssigkeitsdistension der Geb rmutter in der diagnostischen und operativen Hysteroskopie die Infusion von s...

Page 21: ...ng physician the surgical method as such is contraindicated or if the patient is not able to undergo surgery or anesthesia due to his or her general condition Pump systems must not be used for interve...

Page 22: ...ted as suitable for the device by KARL STORZ 3 3 WARNING No responsibility for the safe operation of the device can be accepted if any tubing system other than those specified are used The following s...

Page 23: ...Nationality irrelevant State of health suitable for endoscopic interventions in the physician s judgment 5 3 Qualifikation des Anwenders Der ENDOMAT SELECT darf nur von rzten und medizinischem Assist...

Page 24: ...nded region of treatment on the patient SURG Abdomen GYN Uterus URO Upper and lower urinary tract ART Joints in the foot knee hips shoulder hand and finger ENT NEURO Cleaning endoscope lenses Instrucc...

Page 25: ...digen Ger ten gleichzeitig am Patienten eingesetzt werden Steuerung kann ber den KARL STORZ SCB angesteuert werden 5 8 Intended conditions of use 5 8 1 Use The device is intended for use in clinics an...

Page 26: ...tion des Anwenders F r die Bedienung des Ger ts steht der Anwender innerhalb eines Sichtkegels mit ffnungswinkel von 45 vor dem Ger t in einer Distanz von ca 30 70 cm zur Frontplatte F r die Beobachtu...

Page 27: ...it dem ENDOMAT SELECT zu verwenden 5 11 Safety precautions when operating the device It is the user s responsibility to make sure the device is safe and operates properly before using it During treatm...

Page 28: ...NOTE The ENDOMAT SELECT including the acces so ries connected may only be used in medical rooms in which the electrical equipment has been installed in accordance with applicable national regulations...

Page 29: ...the manufacturer s identification plate 3 3 WARNING Only connect disconnect the power plug to from the power supply outside of areas subject to explosion hazards 3 3 WARNING Grounding reliability can...

Page 30: ...er eine Schutzvor richtung Zum Ausstecken des SCB Kabels daher am Stecker ziehen nicht am Kabel Das SCB Kabel 20090170 an eine der gleich wertigen SCB Buchsen U auf der R ckseite des Ger ts anschlie e...

Page 31: ...selecting the discipline URO for example the screen Select procedure for URO appears Fig 13 1 1 NOTE If a tubing set was selected which only supports certain procedures these will appear bright on th...

Page 32: ...erwendet werden 3 3 WARNUNG Einweg Kassetten und Schl uche sind f r den einmaligen Gebrauch bestimmt und d rfen nicht erneut sterilisiert werden Nach Gebrauch entsorgen Schlauchkassette aufsetzen und...

Page 33: ...uchenden mit dem Sp lfl ssigkeitsbeutel Einstichdorn bzw mit dem Sp lanschluss am Instrument LUER Lock verbinden Abb 18 Connect the correct end of the length of tubing to the irrigation liquid bag pun...

Page 34: ...lfreies Tuch Bleistift Die Fl che auf die die Aufh ngung f r den Flaschenhalter aufgeklebt werden soll mit Alkohol reinigen Dazu ein staub bzw fusselfreies Tuch verwenden Abb 22 Die gereinigte Fl che...

Page 35: ...r This indicator may show up on treated visible surfaces Therefore only apply the adhesion promoter to completely covered surfaces Wait approx 90 seconds The adhesion promoter should be dry before an...

Page 36: ...res see section 6 12 1 page 31 Version A Operation Configure settings on ENDOMAT SELECT see section 6 14 page 38 Turn on the power switch of the CALCUSON if required Pilot lamps T and U must light up...

Page 37: ...vices as one functional unit 1 1 NOTE Observe the accompanying instruction leaflet Tubing Set 97000138 Use the ENDOMAT SELECT with the tubing set 030647 10 which is designed for combined operation Con...

Page 38: ...nal unit 1 1 NOTE Observe the accompanying instruction leaflet Tubing Set 97000138 Use the ENDOMAT SELECT with the tubing set 031523 10 which is designed for combined operation 1 Connect the devices w...

Page 39: ...is recommended to connect a suction bottle see accessories between the suction instrument and the ENDOMAT SELECT Fig 35 Use the disposable turbing set 031647 10 for indirect suction 2 2 CAUTION When t...

Page 40: ...ocated Fig 37 6 Place the outflow tube on the tubing cartridge Waste tube at bottom into a collection container Fig 40 7 Attach the blue end of the 2nd tube in the tube set without cartridge onto the...

Page 41: ...on see Fig 41 1 Insert the hose cartridge see section 6 7 page 24 2 Connect the inflow tube marked orange see Fig 41 with the connector on the instrument 3 Connect the outflow tube marked blue see Fig...

Page 42: ...n gen und der Ist Wert wei e Balkenanzeige f r den Sp lfluss in ml min angezeigt Abb 43 Mit installiertem Advanced Paket UP 610 wird im Anzeigefeld die Begrenzung des Drucks in mmHg angezeigt Mit dem...

Page 43: ...will be fully completed and the subsequent change in rotation direction will cause any remaining liquid to be suctioned back into the sheath Starting the continuous irrigation mode position 2 If the f...

Page 44: ...n order to set values between 100 mmHg and 150 mmHg the button will need to be pressed until the padlock symbol has completely filled up and is shown as opened Fig 46 Advanced software package UP 610...

Page 45: ...ml min HYS URO and 1 500 ml min ART 6 13 4 Starting the irrigation pump If the irrigation pump is activated the white bar in the display field shows the actual value of the irrigation flow see Fig 49...

Page 46: ...Stop button or footswitch button Setting the flow Set the setpoint in 100 ml min increments RES CALCUSON using the buttons This is not affected by the pump status RES Direct Suction 100 ml min 1 000...

Page 47: ...mit der Sollwert Vorgabe siehe orangefarbene Markierungen bereinstimmen Sobald der Zuflusshahn am Instrument geschlossen wurde muss die Rollenpumpe die F rderung einstellen Press the Start Stop button...

Page 48: ...t tigen Sie den Fu schalter um den Absaugvorgang auszul sen Der Istwert f r den Saugfluss kann kontinuierlich an der Balkenanzeige abgelesen werden Abb 57 6 17 Initiating suction Press the footswitch...

Page 49: ...s and Height Difference appears see Fig 60 these items require the Advanced software package UP 610 see page 36 Language Press the term Language in the Settings window see Fig 60 The Language screen a...

Page 50: ...site installed Advanced software package UP 610 3 3 WARNING Using advanced software package UP 610 provides a setting for height difference between the device and the cavity This setting corrects the...

Page 51: ...e the value 4 to ensure precise pressure measurement If you do not make a new selection only the Back button is available If the height difference is set to a positive value the device will factor in...

Page 52: ...50 000 entries If the maximum number of entries is exceeded the oldest entries will be overwritten by new ones All alarms and user information are saved in the event log together with the time of entr...

Page 53: ...eitungsanweisung auf dem Etikett des Zubeh rs muss beachtet werden 2 2 CAUTION Risk of damaging the medical devices The use of chemicals that have not been approved by KARL STORZ or chemical manufactu...

Page 54: ...must be performed and recorded by a qualified electrician at least once a year Visual inspection 1 Check the device and accessories for any mechanical damage which may impair functionality 2 Check tha...

Page 55: ...responsible for the proper disposal of this device Funktionspr fung Funktionskontrolle nach Gebrauchsanweisung durchf hren siehe Abschnitt 6 15 Dokumentation Die Sicherheits berpr fung Wiederholungsp...

Page 56: ...on In order to prevent infection it is strictly forbidden to ship contaminated medical devices All medical devices must be decontaminated on site to avoid contact and aerogenous infections among staff...

Page 57: ...able laws and standards and the device has been used in accord ance with its operating instructions at all times 7 7 Manufacturer s warranty The guarantees provided can be found in the Standard Condit...

Page 58: ...ds during pressure regulated irrigation applications in urology and gynecology 8 1 1 Visual signaling The alarm is shown in the title line The alarm is shown as blue text on a cyan colored background...

Page 59: ...re not self retaining This means that the signal is only issued for the duration that the signal condition is present For very short term signal conditions the minimum display duration is 5 seconds Th...

Page 60: ...nly be output once Ready signal Once a self test has been successfully carried out and the button on the start screen has been pressed a ready signal with the following characteristics will sound The...

Page 61: ...the information signal proceed as follows 1 Switch on the device 2 Correctly insert the pressure regulated tubing cartridge 031523 01 3 Choose one of the following procedures if available Uro CYST Gy...

Page 62: ...Auftreten des Fehlers KARL STORZ Service kontaktieren Ger tedefekt 203 C2B Fehler Ger t aus und einschalten bei wiederholtem Auftreten des Fehlers KARL STORZ Service kontaktieren Selbsttest Kommunikat...

Page 63: ...on nun 5 Sekunden muss der Bildschirm losgelassen und erneut ber hrt werden um eine Kalibrierung zu starten FE Eine Touchscreen Ber hrung l nger als 30 s wurde erkannt 0x750 Elektronik defekt Ger t au...

Page 64: ...i wiederholtem Auftreten des Fehlers KARL STORZ Service kontaktieren Fehler berwachungssystem 0x773 PS Fehler ST Ger t aus und einschalten bei wiederholtem Auftreten des Fehlers KARL STORZ Service kon...

Page 65: ...evice off and on again contact KARL STORZ Service if the error reoccurs Device defect 203 C2B error Turn the device off and on again contact KARL STORZ Service if the error reoccurs Self test Communic...

Page 66: ...creen must be released and touched again within 5 seconds in order to start calibration FE A touch screen activation lasting more than 30 s has been detected 0x750 Defective electronics Turn the devic...

Page 67: ...772 PS error PUST Turn the device off and on again contact KARL STORZ Service if the error reoccurs Error in the monitoring system 0x773 PS error ST Turn the device off and on again contact KARL STORZ...

Page 68: ...rsiste p ngase en contacto con el Servicio T cnico de KARL STORZ Aparato defectuoso 203 Error C2B Desconecte el aparato y a continuaci n con ctelo de nuevo si el error persiste p ngase en contacto con...

Page 69: ...Se ha detectado contacto prolongado con pantalla t ctil durante m s de 30 s 0x750 Sistema electr nico defectuoso Desconecte el aparato y a continuaci n con ctelo de nuevo si el error persiste p ngase...

Page 70: ...si el error persiste p ngase en contacto con el Servicio T cnico de KARL STORZ Error en el sistema de control 0x773 Error PS ST Desconecte el aparato y a continuaci n con ctelo de nuevo si el error pe...

Page 71: ...e occurring in suction system Remedy Check all suction lines and replace any exhibiting evidence of leakage Check the seating of the sealing cap 8 5 Troubleshooting 3 3 WARNING Always unplug the devic...

Page 72: ...al filter Fehlerbeschreibung Keine Saugleistung M gliche Ursachen Schwimmerkugel verschlie t die Saug ffnung Bakterienfilter auf Saugflasche feucht und somit undurchl ssig Abhilfe Fl ssigkeitsstand pr...

Page 73: ...Zusatzpaket f r HYS URO und ART adjustable with Advanced package for HYS URO and ART ajustable con el paquete Advanced para HYS URO y ART SURG 100 2 500 2 500 ml min ADVANCED 100 3 500 3 500 ml min EN...

Page 74: ...ic compatibility in chapter 10 p 70 86 Normenkonformit t f r UP 210 Nach IEC 60601 1 UL 60601 1 CAN CSA C22 2 No 601 1 M90 Art des Schutzes gegen elektr Schlag Schutzklasse I Grad des Schutzes gegen e...

Page 75: ...nstrued 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...

Page 76: ...031529 10 Item Cat no Tubing Set Irrigation PC for single use sterile package of 10 031523 10 Tubing Set Suction BS for single use sterile package of 10 031647 10 Tubing Set Suction DS for single use...

Page 77: ...l 20300032 Bottle stand holder 20300033 Accessories required for operation with CALCUSON Suction bottle 0 5 l sterilizable 20300051 Cap for suction bottle 20300039 Bottle stand for suction bottle 203...

Page 78: ...ms outside the RF shielded room of an ME system for magnetic resonance imaging 3 3 WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result i...

Page 79: ...en sollten nicht n her als 30 cm 12 Zoll an jedem Teil des ENDOMAT SELECT UP210 verwendet werden einschlie lich der vom Hersteller angegebenen Kabel Andernfalls kann es zu Leistungseinbu en kommen 1 1...

Page 80: ...zzeitunterbrechungen und Schwankungen der Versorgungsspannung nach IEC 61000 4 11 Spannungseinbruch Einbruch auf 0 f r 1 Periode bei 0 Phasenwinkel Einbruch auf 70 f r 25 30 Perioden bei 0 Phasenwinke...

Page 81: ...oltage acc to IEC 61000 4 11 Voltage Dip Dip to 0 for 1 cycles 0 phase angle Dip to 70 for 25 30 cycles 0 phase angle Dropout to 0 for 0 5 cycles 0 45 90 135 180 225 270 315 phase angles Voltage inter...

Page 82: ...a norma CEI 61000 4 11 Ca da de tensi n Ca da a 0 para 1 ciclo con un ngulo de fase de 0 Ca da a 70 para 25 30 ciclos con un ngulo de fase de 0 Fallo a 0 para 1 2 ciclo con ngulos de fase de 0 45 90 1...

Page 83: ...m 385 380 390 TETRA 400 Pulsmodulation 18 Hz 27 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz Abweichung 1 kHz Sinuswelle 28 28 710 704 787 LTE Band 13 und 17 Pulsmodulation 217 Hz 9 9 745 780 810 800 960...

Page 84: ...ETRA 400 Pulse modulation 18 Hz 27 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz Sine Wave 28 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA...

Page 85: ...5 380 390 TETRA 400 Modulaci n por impulsos 18 Hz 27 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz desviaci n 1 kHz onda senoidal 28 28 710 704 787 Banda LTE 13 y 17 Modulaci n por impulsos 217 Hz 9 9 745...

Page 86: ...Orta geringer als der bereinstimmungspegel sein b Gestrahlte HF St rgr en nach IEC 61000 4 3 3 V m 80 MHz bis 2 5 GHz 3 V m d 80 MHz bis 800 MHz e 800 MHz bis 2 5 GHz In der Umgebung von Ger ten die d...

Page 87: ...smitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Radiated RF disturbances acc to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m...

Page 88: ...ermina por un estudio electromagn tico del lugar a deber a ser menor que el nivel de conformidad en cada rango de frecuencia b Perturbaciones de RF radiada seg n la norma CEI 61000 4 3 3 V m 80 MHz a...

Page 89: ...F Aussendungen nach CISPR 11 Gruppe 1 Der ENDOMAT SELECT UP 210 verwendet HF Energie ausschlie lich f r die interne Funktion Daher ist die HF Aussendung sehr gering und es ist unwahrscheinlich dass be...

Page 90: ...sed in such an environment RF emissions as per CISPR 11 Group 1 The ENDOMAT SELECT UP 210 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to ca...

Page 91: ...rma CISPR 11 Grupo 1 La ENDOMAT SELECT UP 210 usa energ a de RF exclusivamente para su funci n interna Por ello sus emisiones de RF son muy bajas y no es probable que causen interferencias en los equi...

Page 92: ...chutzabstand d m abh ngig von der Sendefrequenz 150 kHz bis 80 MHz d 80 MHz bis 800 MHz d 800 MHz bis 2 5 GHz e 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 F r Sen...

Page 93: ...er W Separation distance d m as a function of the transmitter frequency 150 kHz to 80 MHz f 80 MHz to 800 MHz f 800 MHz to 2 5 GHz h 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3...

Page 94: ...W Distancia de separaci n d m conforme a la frecuencia del transmisor 150 kHz a 80 MHz d 80 MHz a 800 MHz d 800 MHz a 2 5 GHz e 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100...

Page 95: ......

Page 96: ...TORZ 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...

Page 97: ......

Page 98: ...KARL STORZ SE Co KG Dr Karl Storz Stra e 34 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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