Karl Storz 11301 D1 Скачать руководство пользователя

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9. 5 Verantwortlichkeit

Als Hersteller dieses Gerätes betrachten wir uns

für die Sicherheit, Zuverlässigkeit und Leistung des

Gerätes nur dann als verantwortlich, wenn:
• Montage, Erweiterung, Neueinstellungen,

Änderungen oder Reparaturen durch

von KARL STORZ autorisierte Personen

durchgeführt werden,

• die elektrische Installation des Raumes, in dem

das Gerät angeschlossen und betrieben wird,

den gültigen Gesetzen und Normen entspricht

und

• das Gerät in Übereinstimmung mit der

Gebrauchsanweisung verwendet wird.

9. 6 Garantie

Die Garantiegewährleistungen können Sie

den Allgemeinen Geschäftsbedingungen von

KARL STORZ entnehmen.
Das Medizinprodukt ist immer an die für

Sie zuständige Niederlassung (siehe Kapitel

„Niederlassungen“) auch während der Garantiezeit

einzusenden.
Eigenmächtiges Öffnen, Reparaturen und

Änderungen am Gerät durch nicht autorisierte

Personen entbinden uns von jeglicher Haftung

für die Betriebssicherheit des Gerätes. Während

der Garantiezeit erlischt dadurch jegliche

Gewährleistung.

9. 7 Richtlinienkonformität

(für 11301 D1/11301 D3/11301 D4)

Nach Medical Device Directive (MDD):

Medizinprodukt der Klasse I
Dieses Medizinprodukt ist nach der Medical

Device Directive (MDD) 93/42/EEC mit

CE-Kennzeichen versehen.

9. 8 Normenkonformität

(für 11301 D1/11301 D3/11301 D4)

Nach EN 60601-1, EN 60601-2-18,

ANSI/AAMI ES60601-1/(R) und CAN/CSA

C22.2 No. 60601-1:14 (für NRTL):

Grad des Schutzes gegen elektr. Schlag:
Anwendungsteil des Typs BF

Instandhaltung

Maintenance

9. 5 Limitation of liability

KARL STORZ shall be liable for failure or

deterioration in the safe operation, operational

reliability, and performance of this equipment only

subject to the following conditions:
• all assembly operations, system expansions,

readjustments, modifications or repairs have

been performed by a person or persons duly

authorized by KARL STORZ,

• all electrical installations at the location in which

the device is connected and operated meet the

applicable laws and standards, and

• the unit has been used in accordance with its

operating instructions at all times.

9. 6 Warranty

The warranties provided can be found in the

Standard Conditions of Business of KARL STORZ.
The medical device must always be sent to your

local subsidiary (see chapter ‘Subsidiaries’), even

during the warranty period.
Opening the equipment or performance of any

repairs or modifications to the equipment by

unauthorized persons shall relieve us of any liability

for its performance. Any such opening, repair, or

modification performed during the warranty period

shall void all warranty.

9. 7 Directive compliance

(for 11301 D1/11301 D3/11301 D4)

According to Medical Device Directive (MDD):

This medical device belongs to Class I
This medical device bears the CE mark in

accordance with the Medical Device Directive

(MDD) 93/42/EEC.

9. 8 Standard compliance

(for 11301 D1/11301 D3/11301 D4)

As per EN 60601-1, EN 60601-2-18,

ANSI/AAMI ES60601-1/(R) and CAN/CSA

C22.2 No. 60601-1:14 (for NRTL):

Degree of protection against electric shock:
Applied part type BF

Mantenimiento

9. 5 Responsabilidad

Como fabricantes de este aparato somos

responsables de su seguridad, fiabilidad y

rendimiento solo si se cumplen los siguientes

requisitos:
• Montaje, ampliaciones, reajustes,

modificaciones o reparaciones han sido

realizados exclusivamente por personas

autorizadas por KARL STORZ,

• la instalación eléctrica de la sala, donde el

aparato está conectado y en servicio, en

concordancia con la legislación y las normas

vigentes y

• utilización del equipo de acuerdo con lo

especificado en el Manual de instrucciones.

9. 6 Garantía

Las condiciones de garantía están especificadas

en las condiciones generales de venta de

KARL STORZ.
El producto médico debe enviarse siempre a la sucur-

sal competente (véase el capítulo “Sociedades distri-

buidoras”), también durante el período de garantía.
Cualquier manipulación no autorizada, ya sea la

apertura, reparación o modificación del aparato,

nos exime de cualquier responsabilidad en

relación con la seguridad de su funcionamiento.

Durante el período de garantía, cualquier

manipulación no autorizada rescindirá la garantía.

9. 7 Conformidad con la directiva

(para 11301 D1/11301 D3/11301 D4)

Según la Medical Device Directive (MDD):

Producto médico de la clase I
Este producto médico está provisto del

símbolo CE según la Medical Device Directive

(MDD) 93/42/CEE.

9. 8 Conformidad con las normas

(para 11301 D1/11301 D3/11301 D4)

Según EN 60601-1, EN 60601-2-18,

ANSI/AAMI ES60601-1/(R) y CAN/CSA

C22.2 No. 60601-1:14 (para NRTL):

Grado de protección contra choque eléctrico:
Pieza de aplicación del tipo BF

Содержание 11301 D1

Страница 1: ...HSANWEISUNG 11301 D1 11301 D3 11301 D4 LED Batterielichtquelle INSTRUCTION MANUAL 11301 D1 11301 D3 11301 D4 LED battery light source MANUAL DE INSTRUCCIONES 11301 D1 11301 D3 11301 D4 Fuente de luz LED a pila ...

Страница 2: ...h quality piece of equipment from KARL STORZ This instruction manual is intended to serve as an aid in the proper installation connection and operation of the LED battery light source 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 ...

Страница 3: ...aration 11 7 Application 12 7 1 BOOST mode 13 7 2 End of battery life 13 8 Reprocessing 14 8 1 Manual wipe down disinfection 15 8 2 Assembly inspection and care 15 8 3 Reprocessing limits 16 9 Maintenance 17 9 1 Changing batteries 17 9 2 Disposal 18 9 3 Repair program 18 9 4 Important information 18 9 5 Limitation of liability 19 9 6 Warranty 19 9 7 Directive compliance 19 9 8 Standard compliance ...

Страница 4: ...2 Geräteabbildungen 2 Geräteabbildungen Images of the device 2 Images of the device 2 1 4 11301 D3 7 3 4 5 6 7 8 9 3 Imágenes del equipo 2 Imágenes del equipo ...

Страница 5: ...s displays connectors and their uses 1 Locking mechanism for the cover 2 Mark Locked 3 Batteries 2 x 3 V CR 123 A Art no 121306 P 4 Cover 5 Mark Battery symbol with polarity 6 Housing 7 Screw connection to endoscope fiberscope 8 Light outlet 9 Switch On Off Elementos de control indicadores conexiones y sus funciones 3 Elementos de control indicadores conexiones y sus funciones 1 Bloqueo de la tapa...

Страница 6: ...e UR logo This device has been marked in accordance with the European Directive on waste electrical and electronic equipment WEEE Applied part type BF Batch code Number of products in the product packaging Catalogue number Keep dry Atmospheric pressure limitation Humidity limitation Explicación de los símbolos 4 Explicación de los símbolos Siga el manual de instrucciones Fabricante Emisión de calo...

Страница 7: ...g beachten Auf Batterie Polarität achten Temperature limit Fragile handle with care Consult instructions for use Pay attention to the polarity of the battery Explicación de los símbolos Límite de temperatura Frágil manipular con cuidado Consúltense las instrucciones de uso Preste atención a la polaridad de la pila ...

Страница 8: ... NOTE A Note indicates special information about operating the device or clarifies important information 3 3 Warning Before using the LED battery light source read the following safety instructions carefully to avoid putting your patients personnel or yourself at risk 3 3 Warning Risk of injury material damage if the instruction manual warnings are not observed Read and follow the instruction manu...

Страница 9: ...erile when delivered and must therefore be cleaned and disinfected before the first use and before every subsequent use 1 1 NOTE The LED battery light source is shipped without accessories 3 3 WARNING Interconnection conditions require the applied parts of other medical equipment used within the configuration for endoscopic application to be type BF or type CF applied parts 3 3 WARNING When energi...

Страница 10: ...o wear Failures may occur during use Therefore always keep a replacement system ready 2 2 Caution Protect the LED battery light source from mechanical damage e g from being dropped The glass lens could fragment or parts of the lamp could be damaged 5 2 Battery safety instructions 3 3 Warning The batteries must always come from the same manufacturer and the same packaging and must be changed as a p...

Страница 11: ...ry light source serves as an autonomous light system for connecting to endoscopes and fiberscopes Field of application Brief 10 minutes illumination of small body cavities 5 5 User qualification The LED battery light sources 11301 D1 D3 D4 may only be used by physicians and medical assistants who have a corresponding specialized qualification and who have been instructed in use of the device instr...

Страница 12: ...ent Unauthorized conversions or modifications to the device are prohibited for safety reasons 5 8 Safety precautions at the site of installation The LED battery light sources 11301 D1 D3 D4 may only be used in medical rooms whose electrical systems have been installed in accordance with applicable national regulations Wherever easily combustible and explosive inhalation anesthetics and their mixtu...

Страница 13: ...5 G onto the endoscope see Fig A 2 Screw the model 11301 D3 onto the adapter 495 G at the endoscope light inlet Mounting the battery light source 11301 D1 on the endoscope 1 If necessary unscrew the adaptor 495 F 495 G from the endoscope 2 Screw the model 11301 D1 onto the endoscope light inlet see Fig B Mounting the battery light source 11301 D4 on the endoscope 1 If necessary screw the adaptor 4...

Страница 14: ...y light source before putting it down and never place it in the proximity of the patient according to IEC 60601 1 3 3 Warning Risk of fire During operation the housing of the LED battery light source may heat up The light source must not be covered with cloths or similar immediately after use 3 3 Warning Do not use the LED battery light source as a handle lever effect on the endoscope 1 Check the ...

Страница 15: ...ns the user to the nominal brightness If the switch 9 is not pressed again BOOST mode automatically switches back to the nominal brightness after a certain period of time 7 2 End of battery life The end of the battery s life when battery is empty is signaled by repeated flashing of the LED The user still has at least 5 10 minutes before the battery is completely discharged This is repeated at two ...

Страница 16: ...tion to proper concentration exposure time and service life Prolonged immersion and incorrect concentration may result in damage Bear in mind the microbiologic range of action of the chemicals used 2 2 CAUTION Danger of damage to medical devices The use of chemicals which have not been approved by KARL STORZ may cause damage to the medical devices Only use chemicals approved by KARL STORZ for repr...

Страница 17: ...cleaned and disinfected medical device must be visually inspected for cleanliness completeness damage and dryness If residues or contamination are still present the medical device must be manually cleaned and subjected to a full cleaning and disinfection procedure once more Damaged or corroded medical devices must be withdrawn from use Afterwards a functional check must be carried out 1 1 NOTE In ...

Страница 18: ...timmt Aufbereitung Reprocessing 8 3 Reprocessing limits The end of the product s service life is largely determined by wear reprocessing methods the chemicals used and any damage resulting from use Preparación 8 3 Limitación de la repreparación La vida útil y la capacidad de funcionamiento del producto dependen de la solicitación mecánica y los efectos químicos durante la preparación y la aplicaci...

Страница 19: ...batteries at the same time 1 Remove both batteries 3 2 Dispose of the batteries in an environmentally friendly way see 9 2 Disposal 1 1 Note Observe the polarity see battery symbol 5 3 Insert two new batteries 3 see Fig F Replacing the cover 1 Turn the locking mechanism for the cover 1 clockwise as far as it will go 2 The marks are now aligned and the cover 4 is locked 3 Check the functioning of t...

Страница 20: ...turservice Take off Gewerbepark 83 78579 Neuhausen In other countries please contact your local KARL STORZ subsidiary or authorized dealer 9 4 Important information 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 personnel We reserve the right to return co...

Страница 21: ...must always be sent to your local subsidiary see chapter Subsidiaries even during the warranty period Opening the equipment or performance of any repairs or modifications to the equipment by unauthorized persons shall relieve us of any liability for its performance Any such opening repair or modification performed during the warranty period shall void all warranty 9 7 Directive compliance for 1130...

Страница 22: ...ers 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 maintenance and repair operations described in this manual 1 1 Note We reserve the right to make engineering modificatio...

Страница 23: ...3V Lithium Operating conditions Temperature 10 C 30 C Relative humidity 30 70 Atmospheric pressure 700 to 1080 hPa Storage and transport conditions Temperature 20 C 60 C Relative humidity 10 90 Air pressure 700 to 1080 hPa 2 2 Caution Material damage during transport If not packaged correctly the instrument may be damaged during transportation Always use the original packaging to avoid damage to t...

Страница 24: ...ecause it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally 0 0 WARNING The use of an accessory or cable with the LED battery light source models 11301 D1 11301 D3 and 11301 D4 other than those specified in this manual may result in increased emissions or decreased immunity of the LED bat...

Страница 25: ...herwise degradation of the performance of this equipment could result Note The emission characteristics of this equipment make it suitable for use in professional healthcare environment as well as residential environment CISPR 11 Class B This equipment offers adequate protection to radio communication service In the rare event of interference to the radio communication service the user might need ...

Страница 26: ...inkel Einbruch auf 70 für 25 30 Perioden bei 0 Phasenwinkel Ausfall auf 0 für 1 2 Periode bei 0 45 90 135 180 225 270 und 315 Phasenwinkeln Spannungsunterbrechung 100 für 250 300 Perioden nicht anwendbara Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts oder Krankenhausumgebung entsprechen Wenn der Anwender der LED Batterielichtquelle Modelle 11301 D1 11301 D3 und 11301 D4...

Страница 27: ... kHz Sinuswelle 28 28 710 704 787 LTE Band 13 und 17 Pulsmodulation 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulsmodulation 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulsmodulation 217 Hz 28 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulsmodulation 217 Hz 28 28 5240 5100 5800...

Страница 28: ...bis 800 MHz e 800 MHz bis 2 5 GHz In der Umgebung von Geräten die das folgende Bildzeichen tragen sind Störungen möglich 7 Anmerkung 1 Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich Anmerkung 2 Diese Leitlinien mögen nicht in allen Fällen anwendbar sein Die Ausbreitung elektromagnetischer Größen wird durch Absorptionen und Reflektionen der Gebäude Gegenstände und Menschen beeinflusst a Die...

Страница 29: ...1 D3 und 11301 D4 muss sicherstellen dass das Gerät in einer solchen Umgebung betrieben wird Daher ist die HF Aussendung sehr gering und es ist unwahrscheinlich dass benachbarte elektronische Geräte gestört werden HF Aussendungen nach CISPR 11 Klasse B Die LED Batterielichtquelle Modelle 11301 D1 11301 D3 und 11301 D4 ist für den Gebrauch in allen Einrichtungen einschließlich denen im Wohnbereich ...

Страница 30: ...bstand d m abhängig 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 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...

Страница 31: ...cles 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 interruption 100 for 250 300 cycles not applicablea Mains power quality should be that of a typical commercial or hospital environment If the user of the LED battery light source models 11301 D1 11301 D3 and 11301 D4 requires continued operation during power supp...

Страница 32: ... 28 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 28 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 28 28 5240 5100 5800 WLAN 802 1...

Страница 33: ...rs as determined by an electromagnetic site surveya should be less than the f 80 MHz to 800 MHz h 800 MHz to 2 5 GHz compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol 7 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations The propagation of electromagnetic...

Страница 34: ...s 11301 D1 11301 D3 and 11301 D4 should make sure that it is used in such an environment Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipment RF Emissions as per CISPR 11 Class B The LED battery light source models 11301 D1 11301 D3 and 11301 D4 is suitable for use in all establishments including domestic establishments and those directly ...

Страница 35: ... power of transmitter W Separation distance d m as a function of the transmitter frequency 150 kHz to 80 MHz d 80 MHz to 800 MHz d 800 MHz to 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 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 t...

Страница 36: ...ída a 0 para 1 ciclo con un ángulo de fase de 0 Caída a 70 para 25 30 ciclos con un ángulo de fase de 0 Fallo a 0 para 1 2 ciclo con ángulos de fase de 0 45 90 135 180 225 270 y 315 Interrupción de tensión 100 para 250 300 ciclos no aplicablea La calidad de la red de alimentación debe ser la de un entorno comercial típico o la de un hospital Si el usuario de la fuente de luz LED a pila modelos 113...

Страница 37: ... 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz desviación 1 kHz onda senoidal 28 28 710 704 787 Banda LTE 13 y 17 Modulación por impulsos 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Banda LTE 5 Modulación por impulsos 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Banda LTE 1 3 4 25 UMTS Modulación por impulsos 217 Hz 28 28 1845 1970 2450 2400 2570 Blueto...

Страница 38: ...frecuencia b Perturbaciones de RF radiada según la norma CEI 61000 4 3 3 V m 80 MHz hasta 2 5 GHz 3 V m d 80 MHz hasta 800 MHz e 800 MHz hasta 2 5 GHz La interferencia puede producirse en la vecindad del equipo marcado con el siguiente símbolo 7 Nota 1 A 80 MHz y 800 MHz se aplica el rango de frecuencia más alto Nota 2 Estas directrices no se pueden aplicar en todas las situaciones La propagación ...

Страница 39: ... pila modelos 11301 D1 11301 D3 y 11301 D4 ha de asegurarse de que este sea utilizado en dicho entorno Por ello sus emisiones de RF son muy bajas y no es probable que causen interferencias en los equipos electrónicos en las proximidades Emisiones de RF según la norma CISPR 11 Clase B La fuente de luz LED a pila modelos 11301 D1 11301 D3 y 11301 D4 es adecuado para usarse en todos los establecimien...

Страница 40: ...il de comunicaciones de RF transmisores y el equipo según se recomienda más abajo conforme a la máxima potencia de salida del equipo de comunicaciones Potencia nominal del transmisor W Distancia de separación d m conforme a la frecuencia del transmisor 150 kHz hasta 80 MHz d 80 MHz hasta 800 MHz d 800 MHz hasta 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...

Страница 41: ...30 2310 304868 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 Fax 90 216 442 9030 Sales for Industrial Endoscopy 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 In...

Страница 42: ...KARL STORZ SE Co KG Dr Karl Storz Straße 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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