background image

38

Table 204

Guidance and manufacturer’s declaration – electromagnetic immunity –

for equipment and systems that are not life-supporting

DUOMAT

®

 model 

20

3210 20 is intended for use in the electromagnetic environment specified below. The customer or user of the DUOMAT

®

 model

20

3210 20 should ensure that it is used in such an environment.

Immunity test

EN/IEC 60601

test level

Compliance level

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used
no closer to any part of the DUOMAT

®

 model 

20

3210 20, including

cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF
IEC 61000-4-6

3 V

rms

150 kHz to < 80 MHz

3

V

rms

[

]

P

d

3

/

5

,

3

=

150 kHz to < 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3

V/m

[

]

P

d

3

/

5

,

3

=

80 MHz to < 800 MHz

[ ]

P

d

3

/

7

=

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter 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 survey

a

, should be less than the compliance

level in each frequency range 

b

.

Interference may occur in the vicinity of equipment marked with the
following symbol:

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection by structures, objects and
people.

a

 Field strengths from fixed transmitters, such as base stations for radio [cellular/cordless] telephones and land mobile radios, amateur radio, AM and

FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the unit is used exceeds the
applicable RF compliance level above, the unit should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the unit.

b

 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 

3

 V/m.

Anhang

Hinweise zur elektromagnetischen
Verträglichkeit (EMV)

Anexo

Indicaciones sobre compatibilidad 
electromagnética (CEM)

Appendix

Electromagnetic Compatibility (EMC)
Information

Summary of Contents for DUOMAT

Page 1: ...DUOMAT DUOMAT DUOMAT 203210 20 203210 20 203210 20...

Page 2: ......

Page 3: ...Gebrauchsanweisung Instruction Manual Manual de instrucciones DUOMAT DUOMAT DUOMAT 203210 20 203210 20 203210 20...

Page 4: ...g durch bewahren Sie sie zum etwaigen Nachlesen in der mitgelieferten Schutzh lle an gut sichtbarer Stelle beim Ger t auf This instruction manual is intended to serve as an aid in the proper setup ins...

Page 5: ...III...

Page 6: ...uction line to the instrument Drawer for abridged instructions Power supply cord receptacle Power fuse holder Potential equalization connector Bottle stand Interruptor de la red Conexi n de irrigaci n...

Page 7: ...ittelbaren Umgebung des Ger tes besteht Explosionsgefahr Achtung Nicht ffnen Gefahr eines elektrischen Schlages Lassen Sie Servicearbeiten nur von qualifiziertem Personal durchf hren Danger Risk of ex...

Page 8: ...VI...

Page 9: ...ng up the unit 8 Connecting suction tubing 10 Connecting irrigation tubing 11 Operating the unit 12 Testing the unit for proper operation 12 Maintenance 13 Fuse replacement 13 Cleaning disinfection an...

Page 10: ...parts recommended accessories 26 Spare parts list 26 Accessories 27 KARL STORZ Irrigation Suction and Coagulation System 28 Appendix 29 Cleaning agents and disinfectants 29 Electromagnetic Compatibili...

Page 11: ...unction with KARL STORZ fiberscopes Irrigation and suction are performed at preset constant values thus requiring minimal operating effort Suction irrigation tubes with valves can be used to regulate...

Page 12: ...nten Ihres Personals sowie Ihrer eigenen Person zu vermeiden Warning A Warning indicates that the personal safety of the patient or physician may be involved Disregarding a Warning could result in inj...

Page 13: ...cal plug and cord Do not use if inspection reveals damage Warning Always unplug the unit before doing any maintenance work on it e g cleaning Warning To avoid the risk of electrical shock do not open...

Page 14: ...sponsible for the proper disposal of this unit Before using the unit on the patient it is imperative that you be acquainted with how the unit operates and is controlled Intended use The DUOMAT is a su...

Page 15: ...asily combustible and explosive inhalation anesthetics or mixtures thereof the unit must not be operated inside the hazard zone shown in the diagram This also applies to highly combustible and potenti...

Page 16: ...materials for later use these can come in handy if the unit has to be transported Basic equipment 1 DUOMAT 1 Power cord 1 Instruction manual 1 Plastic wallet for instruction manual 1 Operator s quick...

Page 17: ...sed screw it onto the side of the unit Remove power fuse holder and withdraw voltage preselection module Insert voltage preselection module into power fuse holder so that the mains voltage indicated i...

Page 18: ...rtain that the cap of the suction line bottle is firmly seated since adequate irrigation will not otherwise be achieved Insert the irrigation bottle into its holder Remove the cap of the irrigation bo...

Page 19: ...the LUER lock fitting of the short tube to the short nozzle of the bottle cap Connect the other end of the tube to the unit s fitting Connect the long angled connecting piece of the bottle cap to the...

Page 20: ...or suction and irrigation Suction and irrigation can now be initiated using the valves on the suction irrigation tube or on the suction irrigation handle Testing the unit for proper operation Note The...

Page 21: ...e power fuse holder with a screw driver or other tool Caution Only use fuses of the correct rating Insert new fuses of the appropriate rating 100 120 VAC 230 240 VAC Power fuse 2 x T 0 5 A L 2 x T 0 2...

Page 22: ...ized using validated preparation procedures before initial use and subsequent reuse Warning For all cleaning and disinfec tion procedures on contaminated instru ments tubing sets the guidelines of the...

Page 23: ...ions follow the manufacturer s instructions paying close attention to proper dilution and working times Prolonged immersion can lead to material changes Cleaning preparation Warning For all cleaning a...

Page 24: ...on of exposure 4 Cleaning brushes must be cleaned and disinfected immediately 5 Remove the tubing after the exposure time and rinse with microbiologically pure sterile water Ensure that all chemical r...

Page 25: ...kage tester Sterilization The suction fluid collection bottle and lid includ ing the overflow protection unit can be either steam sterilized or gas sterilized We recommend steam sterilizing the reusab...

Page 26: ...ated prevacuum procedure consists of four phases Conditioning phase The conditioning phase removes air from the chamber by pulling a vacuum up to four times Steam is then blown in Sterilization phase...

Page 27: ...prescribed in different countries we recommend a functional or safety test of the unit at least once a year For detailed instructions please refer to the version of the Service Manual currently valid...

Page 28: ...aparatos o instrumentos cuya reparaci n haya sido realiza da por terceros no autorizados Repair program Usually to bridge the repair period you will receive a unit on loan which you then return to KAR...

Page 29: ...proven to have defects in material or workmanship In so doing we cannot accept to bear the cost of transportation or the risk of shipment The warranty referred to in our Standard Conditions of Busines...

Page 30: ...sible causes Leakage occurring in suction line Remedy Check all suction lines and replace any showing signs of leakage Check the seating of the sealing cap Symptom No suction Possible causes Float of...

Page 31: ...las indicaciones sobre compatibilidad electromagn tica en el Anexo p gs 31 42 Conformidad con la directiva p 20 3210 20 Seg n Medical Device Directive MDD Producto m dico del grupo II b Este producto...

Page 32: ...el regardless of their levels of technical training to open or repair the instrument Explicitly exempted herefrom are those mainte nance and repair operations described in this manual Documentaci n t...

Page 33: ...neral circuit diagram Esquema de distribuci n general 25 Technische Beschreibung Technical description Descripciones t cnicas KG001 Q001 TR001 LF001 M001 IRRIGATION SUCTION 14 VDC F001 240 VAC 230 VAC...

Page 34: ...r Absaugung Silicone tubing set for suction Set de tubos flexibles 20 3000 42 de silicona para succi n Silikon Schlauchset f r Sp lung Silicone tubing set for irrigation Set de tubos flexibles 20 300...

Page 35: ...n 1500 ml 26 3100 38 Druckinfusionsmanschette 3000 ml Pressure cuff 3000 ml Brazalete de infusi n a presi n 3000 ml 26 3101 38 Punktionskan le Puncture needle Aguja de punci n para botella 26173 VG f...

Page 36: ...presenta un nuevo y pr cti co instrumento combinado para aplicaciones lapa rosc picas La base del sistema es un manipula dor apto para autoclave con conexi n para elec trodos y tubos de succi n irrig...

Page 37: ...uperficiales en superficies de aluminio tambi n con revesti miento pl sticos as como en conexiones solda das y menoscabar la durabilidad del instrumen tal En el caso de endoscopios flexibles nica ment...

Page 38: ...uientes productos para limpieza y desinfecci n mec nicas est n autorizados en lo referente a compatibilidad de materiales 30 Anhang Reinigungs und Desinfektionsmittel Appendix Cleaning agents and disi...

Page 39: ...in determining the suitability of the equipment or system for the electromagnetic environment of use and in managing the electromagnetic environment of use to permit the equipment or system to perfor...

Page 40: ...port tiles y m viles puede influir sobre los mismos o bien sobre otros equipos electrom dicos 32 Tabelle 201 Leitlinien und Herstellererkl rung Elektromagnetische Aussendungen DUOMAT Modell 203210 20...

Page 41: ...ectromagn ticas La DUOMAT modelo 203210 20 est prevista para el uso en un entorno electromagn tico especificado debajo El usuario del equipo se deber a asegurar que la DUOMAT modelo 203210 20 se use e...

Page 42: ...leichtaktspannung Die Qualit t der Versorgungsspannung sollte der einer typischen Gesch fts oder Krankenhausumgebung entsprechen Spannungseinbr che Kurzzeitunterbrechungen und Schwankungen der Versorg...

Page 43: ...erential mode 2 kV common mode 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 IE...

Page 44: ...1 kV en modo diferencia 2 kV en modo com n La calidad de la red de alimentaci n deber a ser la de un entorno comercial t pico o la de un hospital Ca das de tensi n interrupciones y variaciones de ten...

Page 45: ...nzen gem einer Untersuchung vor Ort a geringer als der bereinstimmungspegel sein b In der Umgebung von Ger ten die das folgende Bildzeichen tragen sind St rungen m glich Anmerkung Diese Leitlinien m g...

Page 46: ...ixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with...

Page 47: ...io electromagn tico del lugara deber an estar por debajo del nivel de conformidad en cada rango de frecuenciab La interferencia puede ocurrir en la vecindad del equipo marcado con el siguiente s mbolo...

Page 48: ...bis 80 MHz P d 3 5 3 80 MHz bis 800 MHz P d 3 5 3 800 MHz bis 2 5 GHz P d 3 7 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 Nennleistung i...

Page 49: ...ower of transmitter W 150 kHz to 80 MHz P d 3 5 3 80 MHz to 800 MHz P d 3 5 3 800 MHz to 2 5 GHz P d 3 7 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 transmitte...

Page 50: ...salida asignada al transmisor W 150 kHz a 80 MHz P d 3 5 3 80 MHz a 800 MHz P d 3 5 3 800 MHz a 2 5 GHz P d 3 7 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 l...

Page 51: ...78503 Tuttlingen Germany For a period of two years after delivery to the end user we shall replace free of charge equipment that can be proven to have defects in material or workman ship In doing so...

Page 52: ...r te Besitzer auszuf llen Absender Firmenstempel Anwendungsgebiet Ger te Typ Serien Nr Kauf Dat Unterschrift Datum Bitte ausreichend frankieren ANTWORTKARTE KARL STORZ GmbH Co KG Postfach 230 78503 Tu...

Page 53: ......

Page 54: ...of Dr Anton Colorian nr 74 Sector 4 041393 Bukarest Romania Phone 40 0 31 4250800 Fax 40 0 31 4250801 E Mail office karlstorz ro TOV KARL STORZ Ukraine 18b Geroev Stallingrada avenu 04210 Kiev Ukraine...

Page 55: ......

Page 56: ...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 de Web www karlstorz com...

Reviews: