Storz TP012 Instruction Manual Download Page 18

16

Table 1 – Compliance level for Immunity tests

Guidance and manufacturer’s declaration – electromagnetic immunity

The E-Box TP012 is intended for use in the electromagnetic environment specified below. The user of E-Box TP012 should make sure that it is used in 

such an environment.

Immunity tests

EN/IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) 

acc. to IEC 61000-4-2

± 8 kV Contact discharge

 

± 15 kV Air discharge

± 8 kV Contact discharge

 

± 15 kV Air discharge

Floors should be wood, concrete or ceramic tile. 

If floors are covered with synthetic material, the 

relative humidity should be at least 30%.

Rapid transient electrical 

Interferences/bursts acc. to 

IEC 61000-4-4

± 2 kV for power lines

 

± 1 kV for input and output lines
100 kHz repetition 

± 2 kV/1 kV

 

± 1 kV for input and output lines
100 kHz repetition

Mains power quality should be that of a typical 

commercial or hospital environment.

Surges  

acc. to IEC 61000-4-5

± 1 kV line(s) to line(s)

 

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

 

± 2 kV line(s) to earth

Mains power quality should be that of a typical 

commercial or hospital environment.

Voltage dips, short 

interruptions and fluctuations 

of the supply voltage 

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 interruption: 

100 % for 250/300 cycles

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 interruption: 

100 % for 250/300 cycles

Mains power quality should be that of a typical 

commercial or hospital environment. 
If the user of the E-Box TP012 require continued 

operation during power mains interruptions, it is 

recommended that the E-Box TP012 be powered 

from an uninterruptible power supply or a battery. 

Magnetic field at the supply 

frequency 

(50/60 Hz) 

acc. to IEC 61000-4-8

30 A/m at 50 Hz/60 Hz

30 A/m at 50 Hz/60 Hz

If image distortion occurs, it may be necessary to 

position the E-Box TP012 further from sources 

of power frequency magnetic fields or to install 

magnetic shielding. The power frequency magnetic 

field should be measured in the intended installation 

location to assure that it is sufficiently low.

Radiated, radio-frequency, 

electromagnetic field immunity 

test acc. to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

*Refer table 2 for wireless Proximity 

RF field test levels

3 V/m 80 MHz to 2.7 GHz

Immunity to conducted 

disturbances, induced 

by radio-frequency fields 

acc. to IEC 61000-4-6

3 V

rms

 on 150 kHz to 80 MHz 

1 kHz 80% AM modulation 

6 V

rms

 in ISM bands

3 V

rms

 on 150 kHz to 80 MHz 

1 kHz 80 % AM modulation 

6 V

rms

 in ISM bands

Anexo 

CEM

Anhang

EMV

Appendix 

EMC

Summary of Contents for TP012

Page 1: ...Emploi Impiego Utiliza o MANUAL DE INSTRUCCIONES E Box TP012 INSTRUCTION MANUAL TP012 E Box GEBRAUCHSANWEISUNG TP012 E Box...

Page 2: ...relevant instruction manuals and always follow the instructions given Check the functioning of the medical devices used in combination Take note of all the instructions on the device Keep this instruc...

Page 3: ...ith a camera control unit CCU 7 5 3 Disassembly of the E Box 8 6 Reprocessing 9 6 1 Wipe down disinfection 9 6 2 Overview table 9 7 Service repair and disposal 10 7 1 Limitation of liability 10 7 2 Wa...

Page 4: ...eibung 1 Description 1 Descripci n a Videoendoscopio flexible desechable b E Box 3 Z calo de conexi n para videoendoscopio flexible desechable 4 L mpara piloto 5 Monitor C MAC 6 Cable de conexi n a CC...

Page 5: ...CAUTION A caution indicates that particular procedures or precautions must be followed to avoid possible damage to the instrument set 1 1 NOTE A Note indicates special information regarding operation...

Page 6: ...precautions that cannot for a variety of reasons be presented on the medical device itself Catalogue number SN Serial number Number of products in the product packaging 10 60 C 140 F 14 Temperature l...

Page 7: ...peligro para el paciente p ej debido al estado general del paciente o cuando la videoendoscopia como tal est contraindicada 3 3 Cualificaci n del usuario E Box ha de ser empleado nicamente por perso...

Page 8: ...nstruction manuals or the intended purpose and interface specifications of the devices used in combination permit this 3 3 WARNING Inspect the E Box prior to each use to ensure that it functions corre...

Page 9: ...it Anschlussbuchse 3 der E Box verbinden 2 Das Anschlusskabel 6 der E Box mit dem entsprechenden Anschluss an der CCU verbinden 1 1 HINWEIS Beachten Sie die Gebrauchsanweisung der verwendeten Kamera K...

Page 10: ...e C MAC monitor and the E Box firstly gently push in the plug so that it can then be easily removed 2 Remove the connecting cable of the flexible single use videoscope from the connection 3 on the E B...

Page 11: ...uct is not protected against water or moisture and can therefore not be reprocessed sterilized manually using steam or in a washer 6 Preparaci n 2 2 ADVERTENCIA Observe la Instrucci n Limpieza desinfe...

Page 12: ...les de venta de KARL STORZ El producto m dico debe enviarse siempre a la sucur sal competente v ase el cap tulo Sociedades distri buidoras tambi n durante el per odo de garant a Cualquier manipulaci n...

Page 13: ...do realizada por terceros no autorizados 7 5 Gesti n de desechos Este equipo est identificado conforme a la directiva europea referida a aparatos el ctricos y electr nicos viejos waste electrical and...

Page 14: ...al 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 acce...

Page 15: ...si n de entrada 5 V Consumo de potencia 950 mW Indicador de estado LED verde listo para el servicio 9 2 Condiciones de servicio almacenamiento Temperatura Humedad relativa Servicio 0 C 40 C 30 70 Cond...

Page 16: ...Box TP012 including cables specified by the manufac turer Otherwise degradation of the perfor mance of this equipment could result 1 1 NOTE The emission characteristics of this equipment make it suit...

Page 17: ...ngseinbruch Einbruch auf 0 f r 1 Periode bei 0 Phasenwinkel Einbruch auf 70 f r 25 30 Perioden bei 0 Phasenwinkel Abfall auf 0 f r 1 2 Periode bei 0 45 90 135 180 225 270 und 315 Phasenwinkeln Spannun...

Page 18: ...r 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 Voltage Dip Dip to 0 for 1 cycles 0 phase angle Dip to 70...

Page 19: ...a 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 90 135 180 225 270 y 315 Interrupci n de tensi n 100 para 250 300 ciclos Ca da de tensi n Ca d...

Page 20: ...chung 1 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 170...

Page 21: ...ne 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 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 28 28 870 930 1720 1700 1990 GSM 1800...

Page 22: ...desviaci n 1 kHz onda senoidal 28 28 710 704 787 Banda LTE 13 y 17 Modulaci n por impulsos 217 Hz 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Banda LTE 5 Modulaci n por impulsos 18...

Page 23: ...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 das folgende Bildzeichen tragen sind St rungen m glich 7 Anmerkung Bei 80 MHz und 800 MHz gilt...

Page 24: ...evel 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 f 80 MHz to 800 MHz h 800 MHz to 2 5 GHz Interference may occur in the vicinity of equipment m...

Page 25: ...d en cada rango de frecuencia b Perturbaciones de RF radiada seg n la norma CEI 61000 4 3 3 V m 80 MHz a 2 5 GHz 3 V m d 80 MHz a 800 MHz e 800 MHz a 2 5 GHz La interferencia puede producirse en la ve...

Page 26: ...die interne Funktion Daher ist die HF Aussendung sehr gering und es ist unwahrscheinlich dass benachbarte elektronische Ger te gest rt werden HF Aussendungen nach CISPR 11 Klasse B Die E Box TP012 is...

Page 27: ...ergy 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 as per CISPR 11 Class B The E Box TP012...

Page 28: ...or ello sus emisiones de RF son muy bajas y no es probable que causen interferencias en los equipos electr nicos en las proximidades Emisiones de RF seg n la norma CISPR 11 Clase B El E Box TP012 es a...

Page 29: ...gig 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 Sender deren maximale Nen...

Page 30: ...e 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 3 100 12 12 23 For trans...

Page 31: ...paraci 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 12 12 23 Para los...

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Page 34: ...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...

Page 35: ......

Page 36: ...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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