Karl Storz ROTOCUT G1 26713 Series Скачать руководство пользователя

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Instandhaltung

Service and repair

Технический уход

8. 6 Wartung

Eine vorbeugende Wartung ist nicht zwingend

erforderlich. Regelmäßige Wartungen können aber

dazu beitragen, eventuelle Störungen frühzeitig zu

erkennen und so die Sicherheit und Lebensdauer

des Gerätes erhöhen. Wartungsdienste können

bei Ihrer zuständigen Gebietsvertretung oder beim

Hersteller erfragt werden.

8. 6. 1 Sicherheitsüberprüfung

Unabhängig von den in den verschiedenen

Ländern vorgeschriebenen Unfallverhütungsvor-

schriften oder Prüfungsintervallen für Medizin-

geräte müssen an diesem Gerät folgende

Kontrollen mindestens einmal im Jahr von

Personen durchgeführt werden, die aufgrund ihrer

Ausbildung, ihrer Kenntnisse und ihrer durch prak-

tische Tätigkeit gewonnenen Erfahrungen solche

sicherheitstechnischen Kontrollen ordnungsgemäß

durchführen können und die hinsichtlich dieser

Kontrolltätigkeit keinen Weisungen unterliegen.

Sichtprüfung:

•

Gerät und Zubehör auf funktionsbeeinträchti-

gende mechanische Schäden kontrollieren.

•

Sicherheitsrelevante Aufschriften auf Lesbarkeit

kontrollieren

Elektrische Messungen:

•

Kontrolle der Geräteschutzsicherungen

•

Schutzleiterwiderstand gemäß IEC 60601-1/

A2:1995 messen: Grenzwert: 0,2 Ohm

•

Erdableitstrom gemäß IEC 60601-1/A2:1995

messen: Grenzwert: NC: 500 μA, SFC: 1000 μA

•

Patientenableitstrom gemäß IEC 60601-1/

A2:1995 messen: Grenzwert: 100 μA (BF), 10

μA (CF)

•

Ableitströme dürfen nicht größer als die oben

genannten Grenzwerte sein.

Funktionsprüfung:

Funktionskontrolle nach Gebrauchsanweisung

durchführen. Die sicherheitstechnische Kontrolle

ist in das Gerätebuch einzutragen und die

Kontrollergebnisse sind zu dokumentieren. Ist das

Gerät nicht funktions- und/oder betriebssicher,

muss es instandgesetzt werden

8. 6 Maintenance

Preventive maintenance is not essential. Regular

maintenance can, however, contribute to identify-

ing potential problems before they become seri-

ous, thus enhancing the instrument’s reliability and

extending its useful service life. Maintenance servi-

ces can be obtained from your local representative

or from the manufacturer.

8. 6. 1

Safety check

Regardless of the accident prevention regulations

or testing intervals medical devices prescribed in

different countries, the following checks must be

carried out on this device at least once a year by

persons who, due to their training, knowledge,

and practical experience, are able to properly

carry out such safety checks and who are not

subject to any instructions as far as such checking

activities are concerned.

Visual inspection

•

Check the device and accessories for any

mechanical damage which may impair functio-

nality.

•

Check that inscriptions relevant to safety are

legible.

Electric measurements:

•

Inspect the device safety fuses

•

Protective ground resistance measured accor-

ding to IEC 60601-1/A2:1995: Limit value: 0.2

Ohm

•

Earth leakage current measured according to

IEC 60601-1/A2:1995: Limit value: NC: 500 μA,

SFC: 1000 μA

•

Patient leakage current measured according to

IEC 60601-1/A2:1995: Limit value: 100 μA (BF),

10 μA (CF)

•

Leakage currents must not exceed the limit

values specified above.

Test for proper functioning

A functional check must be carried out in

accordance with the instruction manual. The safe-

ty check must be entered in the unit log-book and

the results of the check must be documented. If

the device does not function reliably and/or safely,

it must be repaired.

8. 6

Техобслуживание

Профилактическое техобслуживание

необязательно. Однако регулярное

техобслуживание может способствовать

своевременному выявлению возможных

неисправностей и, следовательно, повышению

безопасности и продлению срока службы

прибора. Адреса технических служб можно

узнать в представительстве Вашего региона или у

производителя.

8. 6. 1

Контроль технического состояния

Независимо от действующих в различных

странах мер по предупреждению несчастных

случаев и предписанных интервалов проверки

медицинского оборудования необходимо

минимум один раз в год проводить следующие

проверки прибора, которые проводятся лицами

с соответствующим образованием, знанием

и опытом в профессиональной деятельности

(проведение технадзора согласно правилам), и не

подчиняющимися каким-либо распоряжениям в

отношении этой контролирующей деятельности.

Визуальная проверка:

• Проверка прибора и принадлежностей на

механические повреждения, нарушающие

функционирование.

• Проверка читаемости предупреждающих

надписей, нанесенных на приборе.

Электрические измерения:

• Проверка защитных предохранителей прибора
• Измерьте сопротивление защитного провода

согласно МЭК 60601-1/A2:1995: предельное

значение: 0,2 Ом

• Измерьте ток утечки на землю согласно МЭК

60601-1/A2:1995: предельное значение: NC:

500 мкА, SFC: 1000 мкА

• Измерьте ток утечки на пациента согласно

МЭК 60601-1/A2:1995: предельное значение:

100 мкА (BF), 10 мкА (CF)

• Токи утечки не должны превышать

вышеуказанные предельные значения.

Проверка функционирования:

Проверьте функционирование в соответствии с

инструкцией по эксплуатации. В журнал прибора

нужно занести сведения о проведении контроля

технического состояния и задокументировать

результаты проверки. Если прибор становится

небезопасным и/или ненадежным в эксплуатации,

его нужно отремонтировать.

Содержание ROTOCUT G1 26713 Series

Страница 1: ...3x Motorensystem UNIDRIVE S III Modell 20701020 1 ROTOCUT G1 Electromechanical Morcellator models 26713x UNIDRIVE S III motor system model 20701020 1 Электромеханический морцеллятор ROTOCUT G1 модели 26713x Моторная система UNIDRIVE S III модели 20701020 1 ...

Страница 2: ......

Страница 3: ......

Страница 4: ...the proper setup installation and ope ration of the ROTOCUT G1 Electromechanical Morcellator and the UNIDRIVE S III control unit All required details and all actions on your 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 for ready reference in a c...

Страница 5: ...Geräteabbildungen Images of the unit Сопроводительные иллюстрации 2 Geräteabbildungen 2 Images of the unit 2 Сопроводительные иллюстрации V ...

Страница 6: ......

Страница 7: ...plays connectors and their uses Элементы управления индикаторы разъемы и их функции 3 Bedienungselemente Anzeigen Anschlüsse und ihre Funktion 3 Controls displays connec tors and their uses 3 Элементы управления индикаторы разъемы и их функции VII P O I Y U E Q w W R T q ...

Страница 8: ...play for selected operating mode set and current speed T Setting the maximum speed of the respective mode Y Connection socket for motor handpiece U Connection socket for footswitch I Connection socket for footswitch control cord O USB port for maintenance only P Potential equalization connection Power socket Line fuse holder q SCB connection w Single pedal footswitch Q Сетевой переключатель для вк...

Страница 9: ...Bedienungselemente Anzeigen Anschlüsse und ihre Funktion Controls displays connectors and their uses Элементы управления индикаторы разъемы и их функции IX e r t y u S i D o p K H J a L A ...

Страница 10: ...uter tube oblique 12 mm p Outer tube oblique 15 mm Outer tube blunt 12 mm Outer tube blunt 15 mm A Handle laparoscopic S Cutter laparoscopic 12 mm D Cutter laparoscopic 15 mm F Protective cap 12 mm diameter not shown G Protective cap 15 mm diameter not shown H Motor valve 12 mm J Motor valve 15 mm K Sealing cap 10 pieces for single use L c Tenaculum forceps 12 mm c Tenaculum forceps 15 mm a Handle...

Страница 11: ...leich Potential equalization Выравнивание потенциалов Rechtslauf Clockwise rotation Вращение по часовой стрелке Plus und Minustaste zum Einstellen der Maximaldrehzahl des jeweiligen Modus Plus and minus buttons for setting the maximum speed of the respective mode Кнопка плюс минус для настройки максимального числа оборотов соответствующего режима Wechselstrom Alternating current Переменный ток Fer...

Страница 12: ...пасности при работе с прибором 11 7 Инструкция по установке и эксплуатации 12 7 1 Распаковка 12 7 2 Основной комплект поставки 12 7 3 Установка и подключение прибора 17 7 3 1 KARL STORZ SCB 20 7 3 2 Подсоединение ножной педали 20 7 3 3 Подключение рабочих инструментов 20 7 4 Ввод в эксплуатацию 21 7 5 Функция UNIDRIVE S III 21 7 5 1 Морцеллятор ROTOCUT G1 23 7 5 2 Обслуживание педального переключа...

Страница 13: ...se 46 8 9 Verantwortlichkeit 46 8 10 Garantie 47 9 Technische Beschreibung 48 9 1 Allgemein 48 9 2 Fehlertabelle UNIDRIVE 49 9 3 Fehlersuchliste 52 9 4 Fehlersuchliste zum Morcellator 54 9 5 Technische Daten 55 9 6 Normenkonformität 56 9 7 Richtlinienkonformität 56 9 8 Technische Unterlagen 57 9 9 Blockschaltbild 58 10 Ersatzteile empfohlenes Zubehör 59 10 1 Ersatzteile 59 11 Anhang 67 11 1 Allgem...

Страница 14: ...possib le also to extract larger quantities of tissue within a short period of time The ROTOCUT G1 system has the following spe cial features Ergonomically optimized design with compact dimensions Optimized weight distribution High quality coated aluminum housing Simplest handling and installation of attach ments Quick action locking technology of attachments requires no tools Proximal sealing tec...

Страница 15: ...ns of the footswitch only with footswitch 20016230 Special features of UNIDRIVE S III Speed range continuously adjustable Preselectable max speed Constant high motor power over the entire speed range Processor controlled speed and motor torque Optimized operator control Clear easily readable controls The unit 207010 20 1 includes the KARL STORZ SCB interface KARL STORZ Communication Bus The SCB in...

Страница 16: ... patient physician or third party is at risk Disregarding a Warning can result in injury to the patient physician or third party 2 2 CAUTION A Caution indicates that parti cular service procedures or precautions must be followed to avoid possible damage to the device 1 1 NOTE A Note indicates special information about operating the device or clarifies important information 3 3 WARNING Read this in...

Страница 17: ...ding reliability can only be achieved when the equipment is con nected to a Hospital Only or Hospital Grade outlet i e approved for use in an operating room environment The plug and cord should be routinely inspected Do not use if damaged 3 3 WARNING Test this device prior to each surgical procedure to ensure that it func tions correctly 3 3 WARNING DO NOT use the UNIDRIVE S III in the presence of...

Страница 18: ...54 2 2 CAUTION Only operate the device with the voltage stated on the device s identi fication plate 2 2 CAUTION When replacing fuses use only fuses of the correct rating 2 2 CAUTION The UNIDRIVE S III may only be operated with accessories which have been designated as suitable for the device by KARL STORZ 2 2 CAUTION Avoid allowing liquids to enter the device Do not store liquids on or above the ...

Страница 19: ...e cutter Never touch the cutting edges with bare fingers when cleaning or servicing 3 3 WARNING Reusable cutters are subject to wear To protect the user and patient against material fatigue the user must ensure that the cutter used is replaced after a maximum of 50 applications 3 3 WARNING Disposable cutters must be replaced after a single use and disposed of 1 1 NOTE Any damage to the device resu...

Страница 20: ...The motor control unit may only be used with accessories replace ment parts and disposable items which have been designated as suitable for the device by KARL STORZ Application instruments used in combination with the motor system must be employed in accordance with their intended use 3 3 WARNING Use of the motor system in fields other than those indicated above is not permitted Unauthorized conve...

Страница 21: ...cal Morcellator may only be used by physicians and medical assistants who have a corresponding specialized qualification 6 4 Safety precautions at the ins tallation location The UNIDRIVE S III motor system may only be used in medical rooms whose electrical systems have been installed in accordance with applicable national regulations The UNIDRIVE S III is equipped with a connector for attaching a ...

Страница 22: ...he UNIDRIVE S III the patient must be treated and kept under observati on with the usual medical care This includes kee ping a check on the progress of treatment as well as monitoring the vital levels and the anesthetic This device has been tested and complies with the EMC limits values as per EN IEC 60601 1 2 2001 CISPR 11 Class B Please read the Electromagnetic Compatibility information in the a...

Страница 23: ...S III control unit 20701020 1 1 Single pedal footswitch 20016230 1 Power cord 400 A 1 SCB connecting cord 20090170 1 Instruction manual 1 Protective wallet for instruction manual 1 Operator s quick reference guide Set no 26713018 12 15 mm Morcellator 1 Hollow shaft motor 267131 30 1 Obturator blunt 12 mm 267130 42 1 Obturator blunt 15 mm 267131 42 1 Outer tube oblique 12 mm 267130 51 1 Outer tube ...

Страница 24: ...1280 1 Motor valve 12 mm diameter 26713053 1 Sealing cap 26713037 single use 1 c Tenaculum 33592 UM 1 Space plate 5 pcs 26713039 Set no 26713114 ROTOCUT G1 laparoscopic 15 mm diameter consisting of 1 Hollow shaft motor 267131 30 1 Obturator blunt 26713142 1 Outer tube oblique 26713151 1 Handle short 26713436 1 Cutter laparoscopic 26713150 1 Protective cap 15 mm diameter 26711080 1 Motor valve 15 m...

Страница 25: ...of 1 Hollow shaft motor 267131 30 1 Outer tube oblique 15 mm diameter 26713357 1 Outer shaft straight 15 mm diameter 26713355 1 Handle 26713436 1 Cutter transvaginal 15 mm diameter 26713352 1 Protective cap 15 mm diameter 26711080 1 Obturator blunt 15 mm 26713356 1 c Tenaculum forceps 15 mm diameter 33652UM 1 Motor valve black 15 mm 26713153 1 Dome 10 mm 26020OM Set no 26713305 likewise without mo...

Страница 26: ...52 Obturator blunt adipose 12 mm diameter 26713442 Obturator blunt adipose 15 mm ø 26713542 Obturator with conical tip adipose 12 mm dia meter 26713441 Obturator with conical tip adipose 15 mm dia meter 26713541 Obturator with pyramidal tip adipose 12 mm ø 26713440 Obturator with pyramidal tip adipose 15 mm ø 26713540 Reducer adipose 12 mm 5 mm diameter 26714460 Reducer adipose 15 mm 5 mm diameter...

Страница 27: ...ons for use with ROTOCUT G1 26713018 26713017 091122 05 likewise for adipose application wor king length 12 5 cm 091115 05 pack of five Cutter set 15 mm diameter sterile for single use working length 9 5 cm Pack of 5 pcs for laparoscopic applications for use with ROTOCUT G1 26713018 26713114 091125 05 likewise for adipose application wor king length 12 5 cm mtp medical technical promotion gmbh Tak...

Страница 28: ...g connection for cleaning 33810 UM Forceps insert 7 3 Installing and connecting the unit 1 1 NOTE The UNIDRIVE S III including the accessories connected may be used only in medical rooms with electrical installations conforming to the applicable national state and local electrical regulations 1 1 NOTE Additional equipment connected to medical electrical equipment must be able to prove their compli...

Страница 29: ...esthetic gases are in use Fitting a label strip 1 1 NOTE The respective controls indicators on the device are designated on the label strip The label strip is enclosed with the device and is in six languages German Spanish English French Italian and Portuguese Select the relevant language Undo the left hand front side cover with a screwdriver Remove any unmarked label strips Select a label strip a...

Страница 30: ...ground line should be installed by a qualified electrician The device may only be operated at the voltage stated on the rating plate 1 1 NOTE 4 A fuses suitable for operation at a 100 240 V supply are inserted in the device at the factory Connect the power cord and insert the power plug fully into the power socket q 3 3 WARNING Only insert the power plug into and remove it from electrical outlets ...

Страница 31: ...t display R 7 3 3 Connecting application instruments Prepare the application instrument according to the instruction manual 1 1 Note Read the accompanying instruction leaflet provided with the application instru ment carefully Connect the connecting cable coming from the application instrument to the motor output M 1 1 Note To unplug the connecting cable pull out the plug do not pull directly on t...

Страница 32: ...1 Указание Перед включением прибора пользователь должен соединить с прибором педальный переключатель и рабочий инструмент Это проверяется программным обеспечением и если необходимо на 7 сегментном индикаторе R отображается соответствующее сообщение о неисправности На время процесса пуска появляется стартовый экран изображенный слева Затем выполняется самодиагностика во время которой ненадолго заго...

Страница 33: ...e automatische Handstückerkennung werden die Standardparameter in den UNIDRIVE S III geladen und auf der 7 Segment Anzeige T angezeigt Hierbei werden die Programme beim erstmaligen Einschalten in Verwendung des ROTOCUT mit P2 oder in Verwendung des Morcellators SUPERCUT SAWAHLE II mit P4 iniziiert Danach werden die Programme mit dem jeweils zuletzt verwendeten Wert iniziiert Die folgende Übersicht...

Страница 34: ...оротов определяется посредством автоматического выбора режима работы Посредством кнопок I значение максимального числа оборотов можно уменьшить с учетом личных представлений и потребностей оперирующего хирурга 1 1 УКАЗАНИЕ Заданное максимальное значение превышать нельзя Настроенные последними значения сохраняются также после выключения блока управления Настройте максимальное число оборотов при пом...

Страница 35: ...гментом индикаторе R текущее фактическое число оборотов рабочего инструмента На малом 7 сегментном индикаторе E после включения блока управления отображается максимальное число оборотов заданное для режима работы соотнесенного с вставленным инструментом Столбиковый индикатор W посредством отдельной светящейся точки показывает настроенное максимальное число оборотов если педаль не нажата При нажато...

Страница 36: ...kwise with dynamic speed Pedal 2 Switching step 1 1 NOTE Switching step 2 has an assigned function exclusively when using the Hystero Shaver 7 5 3 Service mode Service mode makes it possible to request various items of information about the operating status of the UNIDRIVE S III In service mode an operating mode can be saved permanently see page 23 To activate the service mode press the and button...

Страница 37: ...lays E and R show the serial number of the device Digital display E indicates the higher value digits Explanation of errors E01 NOVRAM error E02 motor power board failure E11 no footswitch E12 no motor or failure E13 motor overheating E17 incorrect motor or motor not supported E19 motor has jammed shut down E21 no SCB module 1 1 NOTE For the complete error list refer to page 49 chapter 9 2 By pres...

Страница 38: ...rning Risk of injury Sharp edged cutting tube Can cause injury to tissue even in unactivated state For this reason insert or remove the cutting tube only under visual control Insert the cutting tube together with the obturator into the abdomen When removing the obturator it is recommended that the opening be closed with a finger until insertion of the grasping forceps to avoid sizable losses of ga...

Страница 39: ...rt the motor valve into the flat side of the motor housing You have the choice of 12 mm red or 15 mm versions black uter tube Connect selected outer tube 12 mm 15 mm to the flat side of the motor housing Fit the outer tube on the female thread of the motor housing Fasten outer tube Then fix the selected outer tube to the motor housing by screwing it clockwise Установка клапана мотора Сначала клапа...

Страница 40: ...en Die linke Abbildung zeigt ein komplett eingeführtes System Insert obturator Now insert the obturator into the motorsection until it clicks into place Insert the system The assembled system can be inserted under visual control The picture on the left shows a system that has been inserted fully Ввод обтуратора Теперь в мотор вводится обтуратора пока он не зафиксируется со щелчком Ввод системы Соб...

Страница 41: ...ended for single use and must be replaced after every application Press on the sealing cap The surgeon must insert the sealing cap into the handle fully and check that it is positioned cor rectly 1 1 NOTE We recommend opening the seal with a scalpel under sterile conditions star ting from the center and cutting along the perforated line depending on the forceps diameter obturator diameter used 1 1...

Страница 42: ...after a single use and disposed of 3 3 WARNING Risk of injury from cutter 3 3 WARNING Reusable cutters are not ste rile when delivered They must be sterili zed before being used for the first time see table on page 39 Morcellator acces sories Check for damage before and after cleaning disinfection Lock the cutter Insert the cutter into the handle until it clicks into place audibly Check that the c...

Страница 43: ...be inserted into the cutter without a high level of resistance To prevent injury to the abdominal wall the tissue to be morcellated must be completely detached before applying the Morcellator When using a straight tube additional forceps are recommended to hold the organ in place to pre vent it from rotating during the cutting procedure In order to ensure that the Morcellator with straight shaft c...

Страница 44: ...nd you use a knife to open the sealing cap see page 30 3 3 Warning The quantity of tissue to be grasped with the forceps must be chosen accordingly so that the opened jaws can be inserted into the cutter without a high level of resistance Otherwise damage may be caused to the cutter 1 1 NOTE To pierce the sealing cap open the seal with a scalpel under sterile conditions in the center and along the...

Страница 45: ...thinner patients one or more space plates placed on top of each other can be used to reduce the penetration depth of the outer tube 1 1 NOTE Space plates can be added even when the ROTOCUT handpiece has been inserted by using the lateral slot see small image Fixing the space plates The space plates are inserted laterally onto the outer tube using the slot and are clicked securely into place on the...

Страница 46: ... power Remove the line fuse holder r with a screwdriver or another suitable tool 1 1 Caution Use only fuses with the correct nominal ratings Insert new fuses Insert the power fuse holder again 100 240 V Power fuse 2xT4 0 AH 250V Reconnect the power Check that the instrument works properly 8 Технический уход 8 1 Замена предохранителей Выключите блок управления и отсоедините его от сети Извлеките де...

Страница 47: ...lications 3 3 WARNING Disposable cutters must be replaced after a single use and disposed of Undo the cutter Holding the cutter in one hand and the handle in the other pull them apart The cutter will detach from the handle with a click 3 3 WARNING Be aware of the sharp blade people within the hazard area must maintain a safe distance Remove the sealing cap The sealing cap is still fitted at the ba...

Страница 48: ...e handle the O ring may be replaced 1 1 NOTE Precautionary replacement of the cutter is recommended at three month intervals Hold the handle firmly so that you are looking into the distal patient end opening Place a pointed instrument on the O ring and pierce the O ring with it Lever the O ring inwards out of the groove and lift it out If necessary all residue must be removed from the groove clean...

Страница 49: ...a 8 4 Table of preparation procedures 1 1 NOTE For cleaning and disinfection use a product from the KARL STORZ approved chemicals list see Appendix Please refer to the current list of approved products on our website www karlstorz com 8 3 Очистка дезинфекция и стерилизация 1 1 УКАЗАНИЕ Необходимо соблюдать руководство Очистка дезинфекция стерилизация и уход за инструментами KARL STORZ В нем подроб...

Страница 50: ...nce Clean the motor using the flushing adapter 26713080 at the handle connection proximal then at the tube connection with the cleaning lance attached for approx 30 60 seconds Minimum water pressure necessary 2 bar 29 psi Place motor in enzymatic cleaner for 15 minu tes Change cleaning solution Rinse the motor with clean water using the adapter and cleaning lance then place for a further 15 minute...

Страница 51: ...ning agent can lead to cosmetic changes to the anodized layer However these changes do not have a det rimental effect on the functioning and safety of the motor The hollow shaft motor is suitable for machine thermal disinfection Place the individual components securely in the RDG machine Place the motor upright in a tray holder Connect the flushing adapter to the RDG at all 4 connections and perfo...

Страница 52: ...using the fractionated prevacuum method the sealing cap does not have to be removed for ste rilization 3 3 WARNING Sterilization can only be car ried out successfully on clean disinfected surfaces 3 3 WARNING The recommended steriliza tion parameters are only valid with sterili zation equipment that is properly maintai ned and validated 3 3 WARNING Any deviations from the recommended parameters fo...

Страница 53: ...vacuum procedure The fractionated prevacuum procedure compri ses four phases conditioning phase sterilisation phase evacuation phase and drying phase In the conditioning phase a vacuum is generated up to four times Steam is then blown in and sterilization takes place at 134 C 3 C in 5 minutes minimum time Before the final drying phase the steam is removed from the chamber during the evacuation pha...

Страница 54: ...emperature 54 C 2 C Relative humidity 60 20 Pressure 0 56 bar 0 70 bar Exposure time 120 min EO concentration 600 mg l 30 mg l Gas mixture composed of 10 ethylene oxide and 90 chlorotetrafluoroethane HCFC 124 per cent by weight The airing time is 12 hours at a temperature of 50 55 C This increases to 24 hours at room tem perature 20 C ROTOCUT tray holder system 39510G recom mended for the cleaning...

Страница 55: ...g activities are concerned Visual inspection Check the device and accessories for any mechanical damage which may impair functio nality Check that inscriptions relevant to safety are legible Electric measurements Inspect the device safety fuses Protective ground resistance measured accor ding to IEC 60601 1 A2 1995 Limit value 0 2 Ohm Earth leakage current measured according to IEC 60601 1 A2 1995...

Страница 56: ...it as electronic scrap Please ask either KARL STORZ GmbH Co KG a KARL STORZ subsidiary or your specialist dealer for information on your local collection point Within the scope of application of this Directive KARL STORZ GmbH Co KG is responsible for the proper disposal of this device 8 8 Repair program For fiberscopes and equipment individual repair is necessary Usually to bridge the repair perio...

Страница 57: ...invalidate all war ranty rights KARL STORZ gives no guarantee on the correct functioning of equipment or instruments which have been repaired by unauthorized third parties 8 9 Limitation of liability KARL STORZ shall be liable for failure or deterio ration in the safe operation operational reliability and performance of this equipment only subject to the following conditions all assembly operation...

Страница 58: ...ge and return it as soon as possible to KARL STORZ GmbH Co KG P O Box 230 78503 Tuttlingen Germany 1 1 NOTE The unit must always be sent to the following address also during the warranty period where applicable with warranty card KARL STORZ GmbH Co KG Abt Reparaturservice Dr Karl Storz Str 34 78532 Tuttlingen Germany Opening the equipment or performance of any repairs or modifications to the equip...

Страница 59: ...ce technician 3 3 WARNING Maintenance work that is not mentioned in this chapter must only be performed by technical personnel that are authorized by KARL STORZ General information The UNIDRIVE S III displays error messages in the 7 segment display R Hand the device in for servicing when a hardware error message is displayed E01 E10 Take appropriate action for user error messages E11 E30 E g E11 N...

Страница 60: ...efekt Fussschalter entlasten und erneut starten Kommt der Fehler erneut muss ein neues Handstück verwendet werden 10 E10 11 E11 KEIN FUSSSCHALTER Fussschalter nicht korrekt angeschlossen Fussschalter anschliessen Wenn Fehler noch vorhanden ist prüfen ob der Fehler am Fusschalter oder am Gerät liegt Defektes Teil zur Reparatur 12 E12 KEIN MOTOR Kein Motor Handstück angeschlossen Motor Handstück ans...

Страница 61: ...ly Connect footswitch If the error persists check whether the error is on the footswitch or unit Send the defective component in for repair 12 E12 NO MOTOR No motor handpiece connected Connect motor handpiece 13 E13 MOTOR OVERHEATING M Motor handpiece on channel 1 overheated Allow the connected handpiece to cool down or operate an additional handpiece on the 2nd channel 14 E14 15 E15 16 E16 17 E17...

Страница 62: ...09 НЕИСПРАВЕН МОТОР M Неисправность мотора на канале 1 Отпустите педальный переключатель и перезапустите мотор Если ошибка повторяется нужно использовать новый наконечник 10 E10 11 E11 ОТСУТСТВУЕТ НОЖНАЯ ПЕДАЛЬ Неправильно подключен педальный переключатель Подключите педальный переключатель Если неисправность не была устранена проверьте произошла ли она в педальном переключателе или в приборе Напр...

Страница 63: ...ual making sure to use the correct fuse type Symptom Power switch lamp lights up E11 flashes on the small display E Possible reason Connecting cord to footswitch is defective or not correctly making contact Remedy Check connecting cord to footswitch Inform service outlet Symptom E12 flashes on the small display E Possible cause No motor connected or motor is defective Remedy Check connection of th...

Страница 64: ...lashes on the small display E Possible reason If this error appears the inserted motor is not supported Remedy Insert a motor that is supported or ask a service outlet for software update Symptom E19 flashes on the small display E Possible reason Motor has jammed and shut down Remedy Release footswitch and press it again Reduce speed setting to achieve a higher torque 3 3 ПРЕДУПРЕЖДЕНИЕ Перед пров...

Страница 65: ...pon introduction of the grasping forceps Possible cause The proximal seal is defective Grasping forceps are being used that have not been adjusted to match the Morcellator tube diameter and cutter with a tube diameter that is too small Remedy Insert seal Use forceps with correct tube diameter Symptom There is unusually high gas leakage from the proximal seal without inserted instrument Possible ca...

Страница 66: ...termittent application instrument periodic duty Duty cycle 50 t 1 min Storage transport conditions Humidity 20 95 non condensing Temperature 10 C 60 C Atmosph Pressure 500hPa 1080 hPa Electromechanical Morcellator Max speed max ROTOCUT G1 500 1200 rpm Morcellator n SAWALHE 150 1000 rpm Weight ROTOCUT G1 Motor incl cable 1060 g Torque ROTOCUT G1 l 0 53 Nm Nominal speed I 1200 rpm Nominal power ROTO...

Страница 67: ...cks Applied part type BF Type of protection against moisture drip water protection as per IPX 1 Conforms with IEC 60601 1 2 2001 Please read the Electromagnetic Compatibility information in the appendix pages 73 78 9 7 Directive Compliance Medical product of class IIa This medical device bears the CE mark in accordance with the Medical Device Directive MDD 93 42 EEC 1 1 NOTE The code number after ...

Страница 68: ...ponents of the unit that have been designated by their respective manufacturers as repairable Supply of such technical documentation relating to the unit 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 unit Explicitly exempted herefrom are those main tenance and repair operations described...

Страница 69: ...Technische Beschreibung Technical description Техническое описание 9 9 Blockschaltbild 9 9 Block diagram 9 9 Блокксхема 58 ...

Страница 70: ...бель сетевого питания Hospital Grade США 400 B Gebrauchsanweisung Instruction manual Инструкция по эксплуатации 96116032D Kurzgebrauchsanweisung Operator s quick reference guide Краткая инструкция по эксплуатации 96116032X Elektromechanischer Morcellator ROTOCUT G1 Artikel Article Наименование Bestell Nr Order no кат Hohlwellenmotor mit integriertem Anschlusskabel Hollow shaft motor with integrate...

Страница 71: ...15 mm Нож лапароскопический 15 мм 26713150 Schutzkappe 12 mm Ø Protective cap 12 mm diameter Защитный колпачок Ø 12 мм 26711280 Schutzkappe 15 mm Ø Protective cap 15 mm diameter Защитный колпачок Ø 15 мм 26711080 Motorventil 12 5 mm Motor valve 12 5 mm Клапан мотора 12 5 мм 26713053 Motorventil 15 5 mm Motor valve 15 5 mm Клапан мотора 15 5 мм 26713153 c Tenaculum Zange 12 mm c Tenaculum foreceps ...

Страница 72: ...eter Защитный колпачок Ø 12 мм 26711280 Motorventil 12 mm Motor valve 12 mm Клапан мотора 12 мм 26713053 Dichtungskappe unsteril 10 Stk Einmalanwendung Sealing cap non sterile 10 pieces single use Уплотнительный колпачок нестерильный 10 шт одноразовый 26713037 CLICKLINE Tenaculum Zange 12 mm CLICKLINE Tenaculum forceps 12 mm Щипцы Tenaculum CLICKLINE 12 мм 33592 UM Distanzplatte 5 Stück Space plat...

Страница 73: ...15 mm diameter Защитный колпачок Ø 15 мм 26711080 Motorventil 15 mm Motor valve 15 mm Клапан мотора 15 мм 26713153 Dichtungskappe unsteril 10 Stk Sealing cap non sterile 10 pcs Уплотнительный колпачок нестерильный 10 шт 26713037 c Tenaculum Zange 15 mm c Tenaculum forceps 15 mm Щипцы Tenaculum c 15 мм 33552 UM Distanzplatte 5 Stück Space plate 5 pcs Дистанционная прокладка 5 штук 26713039 ROTOCUT ...

Страница 74: ...щитный колпачок Ø 15 мм 26711080 Obturator 15 mm Ø Obturator 15 mm diameter Обтуратор Ø 15 мм 26713356 c Tenaculum Zange 15 mm c Tenaculum forceps 15 mm Щипцы Tenaculum c 15 мм 33652 UM Motorventil 15 mm Motor valve 15 mm Клапан мотора 15 мм 26713153 Dichtungskappe unsteril 10 Stk Einmalanwendung Sealing cap non sterile 10 pieces single use Уплотнительный колпачок нестерильный 10 шт одноразовый 26...

Страница 75: ...ическим наконечником 15 мм 267131 41 Obturator mit Dreikantspitze 12 mm Obturator with pyramidal tip 12 mm Обтуратор с трехгранным наконечником 12 мм 267130 40 Obturator mit Dreikantspitze 15 mm Obturator with pyramidal tip 15 mm Обтуратор с трехгранным наконечником 15 мм 267131 40 Handgriff lang nur USA Handle long USA only Рукоятка длинная только США 267130 36 O Ring für Handgriff 26713036 und 2...

Страница 76: ...рямой 15 мм 26713152 Distanzplatte Packung zu 5 Stück Space plate package of 5 pcs Дистанционная прокладка в упаковке 5 штук 26713039 Obturator mit kegeliger Spitze 12mm Obturator with conical tip 12 mm Обтуратор с коническим наконечником 12 мм 26713041 Obturator mit kegeliger Spitze 15mm Obturator with conical tip 15 mm Обтуратор с коническим наконечником 15 мм 267131 41 Obturator mit Dreikantspi...

Страница 77: ...mm Obturator with blunt tip 12 mm Обтуратор с тупым наконечником 12 мм 26713442 Messer 15 mm Knife 15 mm Нож 15 мм 26713550 Messer 12 mm Knife 12 mm Нож 12 мм 26713450 Messer Set 12 mm ø steril zum Einmalgebrauch Nutzlänge 12 5 cm Packung zu 5 Stück Cutter set diameter 12 mm sterile single use only working length 12 5 cm pack of 5 Набор ножей ø 12 мм стерильные для одноразового применения рабочая ...

Страница 78: ... be examined for damage such as cracks deformations etc Defective products must not be used under any circum stances During handling the product must not come into contact with objects which could damage it or change its surface 3 3 WARNING Do not use products which show signs of damage or with defective or damaged packaging Products for which the expiration date for sterility use by date have ela...

Страница 79: ... gray to black Products with a black indicator field must not be used Products damaged by high temperatures but with undamaged inner packaging and still usa ble for longer than three months will be replaced with new products free of charge by KARL STORZ in North America KARL STORZ ENDOSCOPY AMERICA Responsibility Complications or other adverse effects resulting from incorrect indication or surgica...

Страница 80: ...nderspezifischen Gesetze und Vorschriften sind zu beachten Disposal To dispose of these medical devices no special measures are necessary National laws and regu lations must be observed Утилизация При утилизации данных медицинских изделий особые меры не требуются Следует соблюдать действующие в данной стране законы и предписания 69 ...

Страница 81: ...ieces prisma tic light deflectors The following instruments pro duced by KARL STORZ must not be placed in an ultrasound cleaning bath Rigid telescopes flexible telescopes other instruments with optical compo nents made of glass When preparing and using the solutions follow the solution manufacturer s instructions paying close attention to proper dilution and recommended immersion times Regarding t...

Страница 82: ...carbide and diamond tip ped drills prismatic light deflectors and magnetic instrument racks Selection of a method for cleaning and disinfection must be discussed with the machine manufacturer and the manufacturer of the chemical reagents Only special procedures must be used which have been verified for this purpose Regarding the microbiological effectiveness please ask the manufacturer Thermal dis...

Страница 83: ... energy exclusively for internal functions 1 1 NOTE The tables and guidelines that are included in this Appendix provide informa tion to the customer or user that is essential in determining the suitability of the equip ment or system for the electromagnetic environment of use and in managing the electromagnetic environment of use to per mit the equipment or system to perform its intended use with...

Страница 84: ...t may have impact on this and other pieces of medical equipment 3 3 WARNING The use of accessories and cables other than those specified in the KARL STORZ instruction manual may result in increased emissions or decreased immunity of the UNIDRIVE S III 20701020 model The accessories and cables listed below have been shown to comply with the requirements of EN IEC 60601 1 2 When using accessories an...

Страница 85: ...uce significant voltage fluctuations or flicker 74 Tabelle 201 Leitlinien und Herstellererklärung Elektromagnetische Aussendungen UNIDRIVE S III Modell 20701020 1 ist für den Betrieb in einer wie unten angegebenen Umgebung bestimmt Der Anwender des Gerätes sollte sicherstellen dass der UNIDRIVE S III Modell 20701020 1 in einer derartigen Umgebung betrieben wird Störaussendungsmessungen Übereinstim...

Страница 86: ... и вероятно не приведет к нарушениям функционирования расположенного вблизи электронного оборудования ВЧ излучение согласно CISPR 11 Класс B Прибор UNIDRIVE S III модели 20701020 1 пригоден для применения в любых ме стах размещения например в больницах и частных врачебных клиниках включая жилые дома и здания непосредственно подключенные к распределительной элек трической сети питающей жилые дома Э...

Страница 87: ...Versorgungsspannung sollte der einer typischen Geschäfts oder Krankenhausumgebung ent sprechen Stoßspannungen Surges nach IEC 61000 4 5 1 kV Gegentaktspannung 2 kV Gleichtaktspannung 2 kV 1 kV Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts oder Krankenhausumgebung ent sprechen Spannungseinbrüche Kurzzeitunterbrechungen und Schwankungen der Versorgungsspannung nach IEC 61...

Страница 88: ...e that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 2 kV 1 kV 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 cycle 70 UT 30 dip in UT for 25 c...

Страница 89: ...трической сети здания должно соответствовать типичным условиям коммерческой или больничной обстановки Микросекундные им пульсные помехи большой энергии согласно МЭК 61000 4 5 1 кВ противофазное напряжение 2 кВ синфазное напря жение 2 кВ 1 кВ Качество электрической энергии в электрической сети здания должно соответствовать типичным условиям коммерческой или больничной обстановки Провалы напряжения ...

Страница 90: ...und d als empfohlenem Schutzabstand in Metern m Die Feldstärke stationärer Funksender sollte bei allen Frequenzen 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 7 Anmerkung Diese Leitlinien mögen nicht in allen Fällen anwendbar sein Die Ausbreitung elektromagnetischer Größen wir...

Страница 91: ...transmit ter in watts W according to the transmitter manufacturer and d is the recommended separation in meters m Field strengths from fixed RF transmitters as 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 These guidelines may not apply in al...

Страница 92: ...ередатчика а d реко мендуемое пространственное разнесение в метрах м Напряженность поля при распространении радиоволн от стационарных радиопередатчиков по результатам наблю дений за электромагнитной обстановкой a должна быть ниже чем уровень соответствия в каждой полосе частот b Помехи могут иметь место вблизи оборудования марки рованного знаком 7 Примечание Приведенные выражения применимы не во в...

Страница 93: ...geräts wie unten angegeben einhält Schutzabstand d m abhängig von der Sendefrequenz Nennleistung des Senders W 150 kHz bis 80 MHz C 80 MHz bis 800 MHz C 800 MHz bis 2 5 GHz C 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 de...

Страница 94: ...t power of the communications equipment Separation distance d m according to frequency of transmitter Rated maximum output power of transmitter W 150 kHz to 80 MHz D 80 MHz to 800 MHz D 800 MHz to 2 5 GHz D 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 meter...

Страница 95: ... выходной мощности средств связи Пространственное разнесение d м в зависимости от частоты передатчика Номинальная мощность передатчика Вт от 150 кГц до 80 МГц C от 80 МГц до 800 МГц C от 800 МГц до 2 5 ГГц C 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 Для передатчиков максимальная номинальная мощность которых не указана в приведенной выше таблице рекомендуемое ...

Страница 96: ......

Страница 97: ...n den Endkunden leis ten wir unentgeltlich Ersatz für nachweisbar fehlerhaftes Material oder mangelhafte Verarbeitung Transportkosten und Versand risiko können dabei nicht übernommen werden Im übrigen gilt die in unseren Allgemeinen Geschäftsbedingungen ange gebene Gewährleistung Vom Lieferanten Importeur auszufüllen Firmenstempel Unterschrift В течение двух лет с момента передачи прибора инструме...

Страница 98: ...eturn address company stamp Field of application Type of device Serial no Purchase date Signature Date Please attach sufficient p ostage Reply card KARL STORZ GmbH Co KG Postfach 230 78503 Tuttlingen Germany Пожалуйста наклейте марку Открытка для ответа ООО КАРЛ ШТОРЦ Эндоскопы ВОСТОК 115114 Москва Дербеневская наб 7 строение 4 Заполняется владельцем прибора Отправитель печать фирмы Область примен...

Страница 99: ...ndoskope Greece Ltd Ipsilantou Str 32 54248 Thessaloniki Greece Phone 30 2310 304868 Fax 30 2310 304862 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 Derbenyevskaya nab 7 building 4 115114 Moscow Russia Phone 7 49...

Страница 100: ...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 ...

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