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Hinweise zur
elektromagnetischen
Verträglichkeit (EMV)

Electromagnetic
Compatibility
(EMC) Information

Indicaciones sobre
compatibilidad
electromagnética (CEM)

Tabelle 8 – TORE von SIGNALEINGANGS-/SIGNALAUSGANGSTEILEN (SIP/SOP)

(gemäß IEC 60601-1-2)

Phänomen

EMV-Grundnorm

STÖRFESTIGKEITS-PRÜFPEGEL

Professionelle Einrichtungen des

Gesundheitswesens

UMGEBUNG IN BEREICHEN

DER HÄUSLICHEN

GESUNDHEITSFÜRSORGE

ENTLADUNG STATISCHER

ELEKTRIZITÄT

IEC 61000-4-2

±8 kV Kontakt
±2 kV, ±4 kV, ±8 kV, ±15 kV Luft

Schnelle transiente elektrische

Störgrößen/Bursts

IEC 61000-4-4

±1 kV
100 kHz Wiederholfrequenz

Stoßspannungen

Leitung gegen Erde

IEC 61000-4-5

±2 kV

Leitungsgeführte Störgrößen,

induziert durch hochfrequente

Felder

IEC 61000-4-6

3 V

0,15 MHz bis 80 MHz
6 V in ISM-Frequenzbändern

zwischen 0,15 MHz und 80 MHz
80 % AM bei 1 kHz

Nicht zutreffend da nur für professionelle

Einrichtungen des Gesundheitswesens

freigegeben

Содержание ENDOMAT SELECT UP 210

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

Страница 2: ...m of equipment from KARL STORZ This instruction manual is intended to serve as an aid in the proper setup installation and operation of the ENDOMAT SELECT All essential details of the equipment and al...

Страница 3: ...Saugpumpe 2 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...

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

Страница 5: ...e eine Fernanzeige von Ger teparametern 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 sin...

Страница 6: ...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 4 2 Symbols on l...

Страница 7: ...ctivated 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 to 50 Flo...

Страница 8: ...FC Flow controlled FESS Functional Endoscopic Sinus Surgery GI Gastrointestinal Gyn Gynecology HYS Hysteroscopy IBS Intrauterine BIGATTI Shaver LAP Laparoscopy NEURO Neurosurgery PC Pressure controlle...

Страница 9: ...4 Training in the operation and function of the device 13 6 5 Patient profile 13 6 5 1 SURG URO ART SPINE ENT NEURO GI VET 13 6 5 2 GYN 13 6 6 Intended region of treatment on the patient 14 6 7 User p...

Страница 10: ...gation flow SURG GI VET SURG 26 7 10 2 Specifying the irrigation flow ENT NEURO 27 7 10 3 Specifying the irrigation pressure HYS URO ART SPINE VET ART 28 7 10 4 Starting the irrigation pump 29 7 11 Us...

Страница 11: ...signaling 47 9 1 2 Acoustic signaling 47 9 1 3 Verification of the functioning of the alarm system 48 9 2 Information signals 48 9 2 1 Visual signaling 48 9 2 2 Acoustic information signal 49 9 3 Test...

Страница 12: ...re displayed If necessary disciplines from the field of human medicine can be added at a later date see Fig 1 An Advanced software package with extended setting options see pages 26 28 29 and 34 can a...

Страница 13: ...by an electronic auto check system which tests the system components each time the device is switched on and notifies the operator of any failures detected 5 2 Schutzrechte Dieses Produkt ist in den...

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

Страница 15: ...evice 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 touc...

Страница 16: ...G Follow the country specific regulations laws for the disposal of accessories WARNING The device may only be operated within specified environmental conditions WARNING The device may be subject to su...

Страница 17: ...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...

Страница 18: ...on Saug Sp lpumpen mit dem entsprechenden Zubeh r eignen sich f r all jene diagnostischen sowie therapeutischen Eingriffe welche die im Kapitel 9 4 Technische Daten vom Ger t bereitgestellten Energien...

Страница 19: ...ysician 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 intervention...

Страница 20: ...ated 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 system other than those specified are used The following se...

Страница 21: ...elevant Nationality irrelevant State of health suitable for endoscopic interventions in the physician s judgment 6 3 Qualifikation des Anwenders Der ENDOMAT SELECT darf nur von rzten und medizinischem...

Страница 22: ...RT Joints in the foot knee hips shoulder hand and finger SPINE Thoracic and lumbar vertebral column ENT NEURO Lens cleaning with endoscopically assisted FESS surgery as well as with endoscopically ass...

Страница 23: ...digen Ger ten gleichzeitig am Patienten eingesetzt werden Steuerung kann ber den KARL STORZ SCB angesteuert werden 6 8 Intended conditions of use 6 8 1 Use The device is intended for use in clinics an...

Страница 24: ...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 Beobachtung de...

Страница 25: ...e und der Narkose mit ein Jeder Behandlungsvorgang darf nur durchgef hrt werden wenn die visuelle Beobachtung der Ger tewirkung sichergestellt ist 6 11 Safety precautions when operating the device It...

Страница 26: ...on 1 NOTE The ENDOMAT SELECT including the accessories connected may only be used in medical rooms in which the electrical equipment has been installed in accordance with applicable national regulatio...

Страница 27: ...rate the device with the voltage stated on the manufacturer s identification plate 3 WARNING Only connect disconnect the power plug to from the power supply outside of areas subject to explosion hazar...

Страница 28: ...e 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 en Abb...

Страница 29: ...g 13 7 6 2 Veterinary medicine After starting up the device a screen is displayed for the user to select the discipline Fig 2 After selecting the discipline VET ART for example the screen Select proce...

Страница 30: ...sposable tubing cartridge 3 WARNING Check the expiration date and the package for possible damage prior to use Products past expiration date or with damaged packaging must not be used 3 WARNING Dispos...

Страница 31: ...auchenden mit dem Sp lfl ssigkeitsbeutel Einstichdorn bzw mit dem Sp lanschluss am Instrument LUER Lock verbinden Abb 19 Connect the correct end of the length of tubing to the irrigation liquid bag pu...

Страница 32: ...is recommended to connect a suction bottle see accessories between the suction instrument and the ENDOMAT SELECT Fig 22 Use disposable turbing set 031647 10 for indirect suction 2 CAUTION When there a...

Страница 33: ...ree bottle connection tube Fig 25 4 Connect the orange end of the tube to the instrument 1 NOTE The suction bottle must be placed at the height of the patient to prevent it from filling up due to the...

Страница 34: ...e Balkenanzeige f r den Sp lfluss in ml min angezeigt Abb 28 Mit installiertem Advanced Paket wird im Anzei gefeld die Begrenzung des Drucks in mmHg angezeigt Mit dem dazugeh rigen Start Stopp Button...

Страница 35: ...removes drops of liquid from the lens When the footswitch is released an ongoing cycle will be fully completed meaning that liquid will still be suctioned into the sheath The display field shows the t...

Страница 36: ...anced software package or VET software package installed Fig 32 33 In the display field flow limitation is shown in ml min The roller pump is activated and deactivated with the associated Start Stop b...

Страница 37: ...for flow limitation are 400 ml min HYS URO 200 ml min SPINE and 1 500 ml min ART 7 10 4 Starting the irrigation pump If the irrigation pump is activated the white bar in the display field shows the ac...

Страница 38: ...button Setting the flow Set the setpoint in 20 ml min increments IBS or 100 ml min increments RES CALCUSON using the buttons This is not affected by the pump status IBS shaver 100 ml min 300 ml min RE...

Страница 39: ...muss 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 b...

Страница 40: ...gang starten Bet tigen Sie den Fu schalter um den Absaugvorgang auszul sen Der Istwert f r den Saugfluss kann kontinuierlich an der Balkenanzeige abgelesen werden Abb 44 7 14 Initiating suction Press...

Страница 41: ...tings and Height Difference appears see Fig 47 these items require the Advanced software package see page 34 Language Press the term Language in the Settings window see Fig 47 The Language screen appe...

Страница 42: ...setting for height difference between the device and the cavity This setting corrects the pressure measurement and control Check the setting after power on to avoid unintended over pressure Press the...

Страница 43: ...this height This can be identified by means of an enduring actual value white bar display which can also be seen even when the pump is not activated If a negative height difference is set the device...

Страница 44: ...0 000 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 entry...

Страница 45: ...roduktes Beachten Sie die Anleitung Reinigung Desinfektion Pflege und Sterilisation von KARL STORZ Instrumenten und die produktbegleitenden Unterlagen 8 1 2 General warnings for reusable medical devic...

Страница 46: ...e Association and equivalent organizations striving to ensure personal safety must be observed 3 WARNING Risk of infection Danger of damage to medical devices The methods listed in instructions for us...

Страница 47: ...suction lances and take the bottle out of the holder 1 NOTE Prompt transportation to the reprocessing station and a subsequent decontamination process must be ensured 8 1 3 1 Accessories Accessories r...

Страница 48: ...of the necessary exposure time the medical device must be rinsed several times in order to remove all chemical residues To this end water of the best possible quality must be used taking into account...

Страница 49: ...sher and disinfector 8 1 3 7 Assembly inspection and care The cleaned and disinfected medical device must be visually inspected for cleanliness completeness damage and dryness If residues or contamina...

Страница 50: ...prevacuum procedure The medical device must be sterilized in its fully assembled state using the fractionated prevacuum procedure DIN EN ISO 17665 1 at 132 C 137 C with a minimum exposure time of 3 m...

Страница 51: ...st 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 that...

Страница 52: ...is responsible for the proper disposal of this device Funktionspr fung Funktionskontrolle nach Gebrauchsanweisung durchf hren siehe Abschnitt 7 12 Dokumentation Die Sicherheits berpr fung Wiederholun...

Страница 53: ...ion 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 staf...

Страница 54: ...able laws and standards and the device has been used in accordance with its operating instructions at all times 8 7 Manufacturer s warranty The guarantees provided can be found in the Standard Conditi...

Страница 55: ...y 3 WARNING Continued use of the pump without eliminating the condition that has lead to the excess pressure alarm can lead to serious undesirable effects for the patient 9 1 1 Visual signaling The al...

Страница 56: ...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...

Страница 57: ...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...

Страница 58: ...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 Gyn HYS SPINE LUMBAR ART Knee or VET...

Страница 59: ...03 C2B Fehler Ger t aus und einschalten bei wiederholtem Auftreten des Fehlers KARL STORZ Service kontaktieren Selbsttest Kommunikationsfehler 20C Neustart in 4 h notwendig Nach 24 h Dauerbetrieb kann...

Страница 60: ...werden um eine Kalibrierung zu starten FE Eine Touchscreen Ber hrung l nger als 30 s wurde erkannt 0x750 Elektronik defekt Ger t aus und einschalten bei wiederholtem Auftreten des Fehlers KARL STORZ S...

Страница 61: ...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...

Страница 62: ...r reoccurs Device defect 203 C2B error Turn the device off and on again contact KARL STORZ Service if the error reoccurs Self test Communication error 20C Restart necessary in 4 h After 24 h of contin...

Страница 63: ...order to start calibration FE A touch screen activation lasting more than 30 s has been detected 0x750 Defective electronics Turn the device off and on again contact KARL STORZ Service if the error re...

Страница 64: ...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...

Страница 65: ...rror C2B Desconecte el aparato y a continuaci n con ctelo de nuevo si el error persiste p ngase en contacto con el Servicio T cnico de KARL STORZ Test autom tico error de comunicaci n 20C Se requiere...

Страница 66: ...a electr nico defectuoso Desconecte el aparato y a continuaci n con ctelo de nuevo si el error persiste p ngase en contacto con el Servicio T cnico de KARL STORZ Error electr nico en el m dulo de cart...

Страница 67: ...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...

Страница 68: ...age occurring in suction system Remedy Check all suction lines and replace any exhibiting evidence of leakage Check the seating of the sealing cap 9 5 Troubleshooting 3 WARNING Always unplug the devic...

Страница 69: ...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...

Страница 70: ...0 ml min 1 500 2 000 2 500 ml min einstellbar mit Advanced Zusatzpaket f r HYS URO SPINE und ART adjustable with Advanced package for HYS URO SPINE and ART ajustable con el paquete Advanced para HYS U...

Страница 71: ...min 41 dBA 1 500 1 500 ml min 65 dBA 2 500 2 500 ml min 69 dBA 3 500 3 500 ml min 71 dBA Abmessungen B x H x T Dimensions w x h x d Dimensiones an x al x pr 305 mm x 110 mm x 260 mm Gewicht Weight Pe...

Страница 72: ...trued 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 a...

Страница 73: ...S for single use sterile package of 10 031647 10 Tubing Set Suction DS for single use sterile package of 10 030647 10 Tubing Set Irrigation FC for single use sterile package of 10 031524 10 Tubing Set...

Страница 74: ...ccessories required for operation with CALCUSON Suction bottle 0 5 l sterilizable 20300051 Cap for suction bottle 20300039 Bottle stand for suction bottle 20300231 Control cable 20701070 Control cable...

Страница 75: ...nerate or use RF energy only for their internal functioning 1 NOTE The tables and guidelines that are included in this chapter provide information to the customer or user that is essential in determin...

Страница 76: ...re HF Kommunikationsger te einschlie lich Peripheriemodule wie Antennenkabel oder externe Antennen d rfen in einem Abstand von 30 cm 12 Zoll zu einem beliebigen Teil des ENDOMAT SELECT UP 210 einschli...

Страница 77: ...tzt wird St raussendungsmessungen bereinstimmung Elektromagnetische Umgebung Leitlinien HF Aussendungen nach CISPR 11 Gruppe 1 Der ENDOMAT SELECT Modell UP 210 verwendet HF Energie ausschlie lich zu s...

Страница 78: ...H USLICHEN GESUNDHEITSF RSORGE ENTLADUNG STATISCHER ELEKTRIZIT T IEC 61000 4 2 8 kV Kontakt 2 kV 4 kV 8 kV 15 kV Luft Hochfrequente elektromagnetische Felder IEC 61000 4 3 3 V m 80 MHz bis 2 7 GHz 80...

Страница 79: ...4 4 2 kV 100 kHz Wiederholfrequenz Sto spannungen Leitung gegen Leitung IEC 61000 4 5 0 5 kV 1 kV Sto spannungen Leitung gegen Erde IEC 61000 4 5 0 5 kV 1 kV 2 kV Leitungsgef hrte St rgr en induziert...

Страница 80: ...IN BEREICHEN DER H USLICHEN GESUNDHEITSF RSORGE ENTLADUNG STATISCHER ELEKTRIZIT T IEC 61000 4 2 8 kV Kontakt 2 kV 4 kV 8 kV 15 kV Luft Schnelle transiente elektrische St rgr en Bursts IEC 61000 4 4 1...

Страница 81: ...Hz Sinus 2 0 3 28 710 704 bis 787 LTE Band 13 17 Pulsmodulation 217 Hz 0 2 0 3 9 745 780 810 800 bis 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulsmodulation 18 Hz 2 0 3 28 870 930 1 720...

Страница 82: ...F 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 acc to CISPR 11 Class B The ENDOMAT...

Страница 83: ...VELS Professional healthcare facility environment HOME HEALTHCARE ENVIRONMENT ELECTROSTATIC DISCHARGE IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Radiated RF EM fields IEC 61000 4 3 3 V m 80 M...

Страница 84: ...sts IEC 61000 4 4 2 kV 100 kHz repetition frequency Surges Line to line IEC 61000 4 5 0 5 kV 1 kV Surges Line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Conducted disturbances induced by RF fields IEC 6...

Страница 85: ...al healthcare facility environment HOME HEALTHCARE ENVIRONMENT ELECTROSTATIC DISCHARGE IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Electrical fast transients bursts IEC 61000 4 4 1 kV 100 kHz...

Страница 86: ...e 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1 720 1 700 1 990...

Страница 87: ...llo sus emisiones de RF son muy bajas y no es probable que causen cualquier interferencia en los equipos electr nicos en las proximidades Emisiones de RF Norma CISPR 11 Clase B La ENDOMAT SELECT model...

Страница 88: ...EL MBITO DE LA ASISTENCIA SANITARIA DOM STICA DESCARGA ELECTROST TICA CEI 61000 4 2 Contacto 8 kV Aire 2 kV 4 kV 8 kV 15 kV Campos electromagn ticos de alta frecuencia CEI 61000 4 3 3 V m 80 MHz hast...

Страница 89: ...2 kV Frecuencia de repetici n de 100 kHz Ondas de choque L nea a l nea CEI 61000 4 5 0 5 kV 1 kV Ondas de choque L nea a tierra CEI 61000 4 5 0 5 kV 1 kV 2 kV Transitorios por conducci n inducidos por...

Страница 90: ...ENTORNO EN EL MBITO DE LA ASISTENCIA SANITARIA DOM STICA DESCARGA ELECTROST TICA CEI 61000 4 2 Contacto 8 kV Aire 2 kV 4 kV 8 kV 15 kV Transitorios y r fagas r pidos CEI 61000 4 4 1 kV Frecuencia de r...

Страница 91: ...i n 1 kHz seno 2 0 3 28 710 704 hasta 787 LTE Banda 13 17 Modulaci n por pulsos 217 Hz 0 2 0 3 9 745 780 810 800 hasta 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Banda LTE 5 Modulaci n por pulsos 18...

Страница 92: ...8 Fax 30 2310 304862 E Mail info gr karlstorz com 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...

Страница 93: ......

Страница 94: ...KARL STORZ GmbH Co KG Mittelstra e 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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