Karl Storz VITOM TH 200 Скачать руководство пользователя

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Technische Beschreibung

11. 2. 1 Normenkonformität

für VITOM

3D Exoskop (TH 200) in Verbindung

mit der KARL

STORZ IMAGE1

S CCU

Nach IEC 60601-1, UL 60601-1,
CAN/CSA C22.2 No.

601.1-M90:

• Art des Schutzes gegen elektr. Schlag:

Schutzklasse III

• Grad des Schutzes gegen elektr. Schlag:

Defibrillationsgeschützt Typ CF

11. 2. 2 Richtlinienkonformität

(für VITOM

3D)

Nach Medical Device Directive (MDD):
Medizinprodukt der Klasse I
Dieses Medizinprodukt ist nach MDD 93/42/EEC
mit CE-Kennzeichen versehen.

Technical description

11. 2. 1 Standard compliance

for VITOM

3D exoscope (TH 200) in connection

with the KARL

STORZ IMAGE1

S CCU

According to IEC 60601-1, UL 60601-1,
CAN/CSA C22.2 No.

601.1-M90:

• Type of protection against electric shock:

Protection Class III

• Degree of protection against electric shock:

Defibrillation-protected Type CF

11. 2. 2 Directive compliance

(for VITOM

3D)

In accordance with the Medical Device Directive
(MDD):
This medical device belongs to Class I
This medical device bears the CE mark in
accordance with MDD 93/42/EEC.

Descripciones técnicas

11. 2. 1 Conformidad con las normas

para el exoscopio VITOM

3D (TH 200) en

combinación con la CCU KARL

STORZ IMAGE1

Conforme a CEI 60601-1, UL 60601-1,
CAN/CSA C22.2 N.º

601.1-M90:

• Tipo de protección contra descarga eléctrica:

categoría de protección

III

• Grado de protección contra choque eléctrico:

protección contra desfibrilación tipo CF

11. 2. 2 Conformidad con las directivas

(para VITOM

3D)

Según la Medical Device Directive (MDD):
Producto médico de clase I
Este producto médico está provisto del símbolo
CE según MDD 93/42/CEE.

Содержание VITOM TH 200

Страница 1: ...GEBRAUCHSANWEISUNG TH 200 VITOM 3D Exoskop TC 014 IMAGE1 PILOT INSTRUCTION MANUAL TH 200 VITOM 3D Exoscope TC 014 IMAGE1 PILOT MANUAL DE INSTRUCCIONES TH 200 Exoscopio VITOM 3D TC 014 IMAGE1 PILOT...

Страница 2: ......

Страница 3: ...on manual is intended to aid you with proper connection and operation of the VITOM 3D in conjunction with the instruction manual for the IMAGE1 S All the necessary details and actions are clearly expl...

Страница 4: ...r teabbildungen 2 Ger teabbildungen 2 1 VITOM 3D Exoskop 1 2 3 4 5 6 7 8 9 Images of the device 2 Images of the device 2 1 VITOM 3D exoscope Im genes del equipo 2 Im genes del equipo 2 1 Exoscopio VIT...

Страница 5: ...on to holding system 3 Rocker switch Scroll up down in menu programmed functions 4 Control button Open menu selection programmed functions 5 Handle 6 Connection for fiberoptic light cable 7 Stereo len...

Страница 6: ...status display 3 3D wheel for control of zoom focus and ROI as well as navigation through the menu 4 Right control button Cancel jump back from a menu and Esc 5 Left control button Open the camera men...

Страница 7: ...ackaging Consult instructions for use Catalogue number SN Serial number Number of products in the product packaging Fragile handle with care Keep dry 10 60 C 140 F 14 Temperature limit Rx ONLY Federal...

Страница 8: ...4 1 Descripci n del aparato 4 5 Instrucciones de seguridad 5 5 1 Indicaciones de alarma y advertencia 5 5 2 Campos de aplicaci n 9 5 2 1 Uso previsto 9 5 2 2 Indicaciones 9 5 2 3 Contraindicaciones 9...

Страница 9: ...6 15 Desmontaje del sistema VITOM 3D despu s del uso 20 7 Manejo del sistema de exoscopio VITOM 3D 21 7 1 Ajuste del plano horizontal 21 7 2 Mando de las funciones pticas del VITOM 3D con la IMAGE1 P...

Страница 10: ...frotado 42 9 4 Comprobaci n despu s de la limpieza 42 9 5 Limitaci n de la repreparaci n 42 10 Mantenimiento 43 10 1 Mantenimiento y verificaci n de seguridad 43 10 1 1 Mantenimiento 43 10 1 2 Verific...

Страница 11: ...OM 3D exoscope the displayed site is enlarged on a 3D screen The VITOM 3D exoscope is compatible with the IMAGE1 S via the D3 LINK The VITOM 3D exoscope is positioned for use with the aid of a holding...

Страница 12: ...sure safe and efficient operation of the device 3 WARNING A Warning indicates that the personal safety of the patient or physician may be involved Disregarding a Warning could result in injury to the...

Страница 13: ...that they are complete free from damage and in full working order and have no unintentional rough surfaces sharp corners burred edges or projecting parts Care must be taken not to leave missing or bro...

Страница 14: ...e lowest possible light output of the cold light source which still allows optimal illumination of the operating field 3 WARNING Risk of injury Optical radiation poses a risk of injury to eyes Never l...

Страница 15: ...unauthorized staff voids the warranty 3 WARNING Risk of fatal injury In the case of patients with cardiac pacemakers it must be ensured that the proximal end furthest from the patient of the telescope...

Страница 16: ...ources are not intended for use in ophthalmology the use of the VITOM 3D system is also contraindicated in this field 5 3 Patient profile The use of the VITOM 3D is not limited to a certain patient pr...

Страница 17: ...nt must be treated and kept under observation with the usual medical care This includes keeping a check on the progress of treatment as well as monitoring the vital signs and the anesthetic 1 NOTE Any...

Страница 18: ...ponsibility to make sure the instrument is safe and operates properly before using it During treatment in conjunction with the VITOM 3D exoscope the patient must be treated and kept under observation...

Страница 19: ...T module TC 200 EN 1 IMAGE1 S D3 LINK module TC 302 1 32 3D monitor TM 323 1 3D polarization glasses 9800 GF VITOM 3D exoscope 1 VITOM 3D exoscope TH 200 1 IMAGE1 PILOT TC 014 1 Sterile cover for VITO...

Страница 20: ...y provided or contact your KARL STORZ service partner If it is necessary to upgrade the hardware of the compatible Link module TC 302 the system will show you this For more information on this please...

Страница 21: ...e VITOM 3D exoscope 6 6 Attaching the VITOM 3D exoscope to the holding arm For operation of the VITOM 3D exoscope a KARL STORZ holding arm e g endoscopic holding system which can carry a load of at le...

Страница 22: ...VITOM 3D can be swiveled in all directions either via the ball joint on the clamping jaw Art no 28272 VTK or via the integrated ball joint in the POINT SETTER 1 NOTE Before every intervention check wh...

Страница 23: ...D exoscope and features a plastic frame with a transparent screen in the distal area Remove the sterile cover from its packaging see Fig G Insert the plastic frame over the cover glass and light outle...

Страница 24: ...16335DF The IMAGE1 PILOT is equipped with a KSLOCK quick release coupling male on its underside and can thus be easily attached to KARL STORZ articulated stands see Fig J To this end open the KSLOCK q...

Страница 25: ...g the USB connection or powering up the IMAGE1 S system 6 10 Fitting the IMAGE1 PILOT with a sterile cover The IMAGE1 PILOT cannot be sterilized and is therefore fitted with a sterile cover during the...

Страница 26: ...eed the instruction manuals for the IMAGE1 S the light source the light cable and the monitor 6 14 Optimal light efficiency 1 NOTE The entrance and exit faces of the light cable and VITOM 3D must be k...

Страница 27: ...OM 3D exoscope and IMAGE1 PILOT from the holding system perform a wipe down disinfection also see chapter 8 Reprocessing and keep both safe 1 NOTE The handle on the VITOM 3D exoscope can become very h...

Страница 28: ...able buttons on the IMAGE1 PILOT or to the camera head buttons Also see chapter 7 4 Programmable function buttons on the IMAGE1 PILOT 1 NOTE To avoid damage to the VITOM 3D exoscope do not turn the kn...

Страница 29: ...sely 7 2 2 Adjusting the focus The working distance of the VITOM 3D can be variably adjusted from 20 50 cm The 3D Wheel enables focusing of the image at any time To bring a lower level greater working...

Страница 30: ...uired direction see Fig Z and a The more you press the 3D Wheel the faster you will be able to move the region of interest 1 NOTE The region of interest can only be moved in the image level This does...

Страница 31: ...arge rectangle shows the available overview area As soon as you use the zoom a small filled rectangle which represents the selectable region of interest appears The size of the rectangle varies with t...

Страница 32: ...sary see Fig c As soon as the menu of the IMAGE1 S is called up using the ENTER button you can navigate through the menu adjust settings or call up functions by moving the 3D Wheel You can exit the me...

Страница 33: ...r button on the left Call up the IMAGE1 S menu and confirm a function Pressing the ENTER button for longer calls up the Setup menu of the IMAGE1 S Move the 3D Wheel to navigate through the IMAGE1 S me...

Страница 34: ...Brightness Nothing Source swap AEL Activate Image Flip 7 5 Advanced Exposure Levelling AEL function The function Advanced Exposure Levelling AEL stabilizes the Exposure control in situations with ext...

Страница 35: ...the operating field is displayed too dark The exposure is stabilized when the AEL function is activated The reflection on the instrument may become larger however the operating field is displayed wel...

Страница 36: ...he AEL function the VITOM 3D returns to the normal exposure mode 7 6 Extended PIP Swap function The PIP Swap function can be assigned to one of the programmable buttons on the IMAGE1 PILOT As soon as...

Страница 37: ...ITOM 3D exoscope can alternatively be operated via the touchpad 1 NOTE For safety reasons always connect the keyboard to the IMAGE1 S Zoom By moving your finger upward on the touchpad the image view i...

Страница 38: ...ng the ROI By holding the left mouse button depressed and moving your finger on the touchpad the magnified region of interest can be moved in the x and y direction Operation of the VITOM 3D exoscope s...

Страница 39: ...ink while storing Do not expose the VITOM 3D unprotected to direct sunlight or excessive heat When returning the VITOM 3D for service the user must ensure the equipment being returned is clean and wip...

Страница 40: ...onnecting cable and of the light cable must also be completely dry before connecting NEVER PICK UP THE VITOM 3D BY ITS CABLE Always pick up the set by the instrument handle first followed by the cable...

Страница 41: ...hemothermal disinfection Desinfecci n qu mica Thermische Desinfektion Thermal disinfection Desinfecci n t rmica Konnektierung Connection Conexi n Dampfsterilisation Steam serilization Esterilizaci n p...

Страница 42: ...indication that reprocessing has not been carried out or has been carried out incorrectly Reprocess the medical devices before initial use and before and after every subsequent use using validated pro...

Страница 43: ...erior surfaces of the medical device with a disposable cloth moistened with disinfectant or a ready to use soaked disinfectant cloth Due to their protein fixating effect and possible material incompat...

Страница 44: ...rwards a functional check must be carried out 8 5 Reprocessing limits The product s service life and correct functioning are largely determined by mechanical stress and chemical influences within the...

Страница 45: ...excessive heat Prior to returning for service the VITOM 3D must be thoroughly cleaned per validated procedures The entrance and exit faces of the light cable and exoscope must always be kept clean se...

Страница 46: ...tely dry before connecting NEVER PICK UP THE VITOM 3D BY ITS CABLE Always pick up the set by the instrument handle first followed by the cable and connector The cable contains tiny electronic conducto...

Страница 47: ...n qu mica Thermische Desinfektion Thermal disinfection Desinfecci n t rmica Konnektierung Connection Conexi n Dampfsterilisation Steam serilization Esterilizaci n por vapor STERRAD 50 100S 200 STERRA...

Страница 48: ...non sterile medical devices poses a risk of infection for patients users and third parties Inspect medical devices for visible contamination Visible contamination is an indication that reprocessing ha...

Страница 49: ...free from any visible signs of damage cuts dents or scratches etc that may trap residual debris If the device shows any damage contact KARL STORZ for repairs 9 5 Reprocessing limits The product s ser...

Страница 50: ...ons who due to their training knowledge and practical experience are able to properly carry out such metrological checks and who are not subject to any instructions as far as such checking activities...

Страница 51: ...r the lens Opening these sealed assemblies affects the camera s tightness and voids all warranties The covers on the camera processor must only be removed by authorized personnel 10 3 Disposal This de...

Страница 52: ...en 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 contaminated instru...

Страница 53: ...laws and standards and the device has been used in accordance with its operating instructions at all times 10 6 Warranty The warranties provided can be found in the Standard Conditions of Business of...

Страница 54: ...ary knob for mechanical image alignment 90 Interfaces Video interface for the IMAGE1 S D3 LINK module Interface for fiberoptic light cable Interface for attaching a holding system using the clamping j...

Страница 55: ...th 6 DoF Degrees of Freedom 4 programmable buttons 2 buttons for menu navigation Interfaces USB interface for operation with the IMAGE1 S CONNECT KSLOCK for fast and secure fixation on KARL STORZ hold...

Страница 56: ...f protection against electric shock Protection Class III Degree of protection against electric shock Defibrillation protected Type CF 11 2 2 Directive compliance for VITOM 3D In accordance with the Me...

Страница 57: ...rnal functioning 1 NOTE The tables and guidelines that are included in this chapter provide information to the customer or user that is essential in determining the suitability of the equipment or sys...

Страница 58: ...s of medical equipment 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 device...

Страница 59: ...n Aussendung von Oberschwin gungen nach IEC 61000 3 2 Klasse A Aussendungen von Spannungs schwankungen Flicker nach IEC 61000 3 3 Stimmt berein Information on electromagnetic compatibility EMC Table 1...

Страница 60: ...rupo 1 El exoscopio VITOM 3D modelo TH 200 usa energ a de RF solo para su funci n interna Por ello sus emisiones de RF son muy bajas y no es probable que causen cualquier interferencia en los equipos...

Страница 61: ...rde 1 kV Spannung Au enleiter Au enleiter 2 kV Spannung Au enleiter Erde Die Qualit t der Versorgungsspannung sollte der einer typischen Gesch fts oder Krankenhausumgebung entsprechen Spannungseinbr c...

Страница 62: ...Surge 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 Volt...

Страница 63: ...n la norma CEI 61000 4 5 1 kV tensi n l nea externa l nea externa 2 kV tensi n l nea externa tierra 1 kV tensi n l nea externa l nea externa 2 kV tensi n l nea externa tierra La calidad de la red de a...

Страница 64: ...inger als der bereinstimmungspegel sein b In der Umgebung von Ger ten die das folgende Bildzeichen tragen sind St rungen m glich 7 Anmerkung 1 Bei 80 MHz und 800 MHz gilt der h here Frequenzbereich An...

Страница 65: ...and d is the recommended separation distance 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 fr...

Страница 66: ...as intensidades del campo desde el transmisor fijo de RF seg n se determina por un estudio electromagn tico del lugar a deber a estar por debajo del nivel de conformidad en cada rango de frecuencia b...

Страница 67: ...MHz C 80 MHz bis 800 MHz C 800 MHz bis 2 5 GHz F 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 in obiger Tabelle nicht angegeb...

Страница 68: ...ns equipment Rated maximum output power of transmitter W Separation distance d m according to frequency of transmitter 150 kHz to 80 MHz D 80 MHz to 800 MHz D 800 MHz to 2 5 GHz F 0 01 0 12 0 12 0 23...

Страница 69: ...o Potencia nominal del transmisor W Distancia de separaci n d m conforme a la frecuencia del transmisor 150 kHz hasta 80 MHz C 80 MHz hasta 800 MHz C 800 MHz hasta 2 5 GHz F 0 01 0 12 0 12 0 23 0 1 0...

Страница 70: ...E P E Patriarhou Grigoriou E 34 54248 Thessaloniki Greece Phone 30 2310 304868 Fax 30 2310 304862 E Mail info karlstorz gr Repair Service Subsidiary KARL STORZ Industrial Gedik Is Merkezi B Blok Kat 5...

Страница 71: ......

Страница 72: ...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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