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Related Manuals for Storz VITOM EAGLE
Summary of Contents for Storz VITOM EAGLE
- Page 1 Instructions for use VITOM EAGLE...
- Page 2 05-2023 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
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Page 3: Table Of Contents
Table of contents Table of contents 1 General information ......................... 1.1 Read the instructions for use ..................... 1.2 Read the instructions for use of compatible products ............... 1.3 Scope ............................1.4 General signs and symbols ......................1.5 Description of warning messages ....................2 Normal use ............................2.1 Intended use ... - Page 4 Table of contents 6.3 Selecting the region of interest ....................21 6.4 Function buttons on the VITOM EAGLE ..................23 6.4.1 Preset functions ......................23 6.4.2 Programmable functions ....................23 6.5 Controlling the IMAGE1 S with IMAGE1 PILOT ................. 24 6.6 Function buttons on the IMAGE1 PILOT ...
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Page 5: General Information
General information 1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Read the reprocessing instructions carefully and follow all the safety notes and warnings. -
Page 6: Description Of Warning Messages
General information Lists Numbered list – Unnumbered list, 1st level – Unnumbered list, 2nd level 1.5 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warnings use the following levels of danger: WARNING WARNING Designates a possible imminent risk. -
Page 7: Normal Use
Furthermore, the medical devices must not be used for ophthalmologic interventions because KARL STORZ light sources are contraindicated in this specialty. 2.4 Clinical benefits Exoscopes (2D exoscopes and 3D exoscopes) and the support components assist surgical interventions by providing “heads up”... -
Page 8: Safety And Warning
Safety and warning 3 Safety and warning WARNING Danger due to non-observance of warnings and safety notes This chapter contains warnings and safety notes structured according to hazards and risks. 1. Carefully read and observe all warnings and safety notes. 2. -
Page 9: Dangers From Electrical Current
Safety and warning 3.5 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. Do not use multiple socket outlets with this device. If the use of a multiple socket outlet cannot be avoided: Only use a multiple socket outlet with an isolation transformer in accordance with IEC 60601-1. -
Page 10: Failure Of Products
Safety and warning 3.11 Failure of products The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique. Instructions for use • VITOM EAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR... -
Page 11: Product Description
Product description 4 Product description 4.1 Product overview Function buttons Connection for holding system Release button for manual positioning Power cord connection socket Fiber optic light cable Video cable Cover glass Aperture filter rotating wheel 4.2 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. -
Page 12: Symbols On The Packaging
Product description Light cable diameter Symbol Endoscope diameter Symbol 2.0 mm ... 2.5 mm 0.8 mm ... 2.9 mm 3.0 mm ... 3.5 mm 3.0 mm ... 6.5 mm 4.8 mm ... 5.0 mm 6.6 mm ... 12.0 mm 4.3 Symbols on the packaging Symbol Meaning Manufacturer... -
Page 13: Symbols On The Product
EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 4.4 Symbols on the product Symbol... -
Page 14: Technical Data
Product description 4.5 Technical data VITOM EAGLE Description Value Weight 4.5 kg Dimensions (W x H x L) 97 x 227 x 366 mm Max. temperature 48°C (118°F) Requirements for a US power cord for external power supply Description Value Socket IEC60320 C7 Connector NEMA 1-15 Nominal data UL/CSA 10 A / 125 VAC; 50/60 Hz Electric strength > 2 kVDC between L-N > 2 kVAC between L/N-PE (1 min/50 Hz) Permissible operating temperature -25°C ... 70°C (-13°F ... 158°F) -
Page 15: Preparation
The product is operated with the IMAGE1 PILOT (TC014). Fasten the IMAGE1 PILOT to the operating table using a KARL STORZ articulated stand. Position the IMAGE1 PILOT in such a way that the control unit can be reached with ease. Fasten the holding arm to the operating table and place in position. -
Page 16: Connecting The Vitom Eagle
Preparation Make sure that the IMAGE1 PILOT has engaged. Lock the KSLOCK quick release coupling (female) on the articulated stand by turning it in the “CLOSE” direction. Attach the USB cable of the control unit to a USB socket on the IMAGE1 S CONNECT II. ð... -
Page 17: Attaching Sterile Drapes
Preparation Connect the fiber optic light cable to the VITOM EAGLE connection socket for fiber optic light cables. Insert the fiber optic light cable in the holder on the VITOM EAGLE. Connect the fiber optic light cable to a light source. Connect the video cable of the VITOM EAGLE to the camera control unit of the IMAGE1 S. 5.5 Attaching sterile drapes The VITOM EAGLE and the IMAGE1 PILOT cannot be sterilized and must therefore be fitted with a sterile drape for the duration of the procedure. - Page 18 Preparation Unfold the sterile drape as indicated. Pull the plastic frame of the sterile drape over the cover glass. Pull the sterile drape over the VITOM EAGLE and the holding system. Remove the sterile drape for the IMAGE1 PILOT (041150-20) from its packaging. Cover the IMAGE1 PILOT control unit with the sterile drape.
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Page 19: Performing The White Balance
Preparation Ensure that the elastic insert on the tip of the sterile drape is placed directly over the IMAGE1 PILOT. 5.6 Performing the white balance The white balance must be performed before every procedure. Failure to perform proper white balance of system may result in color distortion. Ensure that an imaging instrument is connected and a live image appears on the monitor. -
Page 20: Application
The functions listed here may not yet be available in all countries due to differences in approval requirements. The VITOM EAGLE image is rotated around the center point. This enables flexible positioning of the VITOM EAGLE and correction of the horizontal image alignment during the application. -
Page 21: Selecting The Region Of Interest
Application To reduce the image, pull on the 3D Wheel. ð The focal distance can be continuously adjusted from 20 to 50 cm. ð While the image is being magnified or reduced, the status of the zoom function is shown at the top right. - Page 22 ð The region of interest can only be moved at image level. ð This does not change the angle of view of the VITOM EAGLE relative to the object. When the 3D Wheel is activated, an overview appears at the top right.
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Page 23: Function Buttons On The Vitom Eagle
When the menu is active: navigate downward Focus on a lower level Focus on a lower level Open Live menu Open Setup menu 6.4.2 Programmable functions The VITOM EAGLE function buttons can be programmed and the following functions assigned to them: – White Balance – Capture –... -
Page 24: Controlling The Image1 S With Image1 Pilot
Application – PiP Swap – Image Flip Call up the Head Buttons. Select Head Button Left or Head Button Right. ð A drop-down menu will open. Select the desired function. ð The button is linked to the selected function. 6.5 Controlling the IMAGE1 S with IMAGE1 PILOT The menu of the IMAGE1 S can be operated using the IMAGE1 PILOT. -
Page 25: Function Buttons On The Image1 Pilot
Application Move the 3D Wheel to navigate through the IM- AGE1 S menu. Press the 3D Wheel to confirm your selection. Pull the 3D Wheel to jump back from a menu or cancel an action. 6.6 Function buttons on the IMAGE1 PILOT The 4 buttons on the IMAGE1 PILOT or on the microscope footswitch can be programmed and assigned functions. -
Page 26: Setting Image Lighting
Application – Light Source Intensity – Video – Brightness – Nothing – PiP Swap – Image Flip Open the IMAGE1 PILOT menu. Choose a button. ð A drop-down menu will open. Select the desired function. ð The button is linked to the selected function. 6.7 Setting image lighting The functions listed here may not yet be available in all countries due to differences in license models. -
Page 27: Activating Blue Light Imaging (Bli)
Application Select the Fl Intensity button. To increase the intensity, turn the 3D Wheel clockwise. To reduce the intensity, turn the 3D Wheel counterclockwise. For an optimal fluorescent image, a working distance of less than 30 cm is recommended. For an optimal fluorescent image, a zoom factor lower than four is recommended. 6.7.2 Activating Blue Light Imaging (BLI) Blue Light Imaging (BLI) can be used to display fluorescence such as 5-ALA. -
Page 28: Pip-Swap Function
Application Select the OPAL1 button. Select the Fl Mode button and the required mode. Select the Fl Switch button and activate ICG. To set the intensity, select the Fl Intensity button. If Overlay is active, select the Overlay Color button and the required color. If Overlay is active, select the Overlay Opacity button and the required opacity. -
Page 29: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product Switch off the products. To disconnect the VITOM EAGLE from the power supply, remove the VITOM EAGLE power cable from the power supply. Disconnect the holding system from the power supply. Disconnect the IMAGE1 S and the 4U-LINK from the power supply. Wait until the VITOM EAGLE has completely cooled down. -
Page 30: Maintenance, Servicing, Repairs, And Disposal
8.2 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). -
Page 31: Accessories And Spare Parts
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order no. Fiber Opt. Light Cable, 600cm, Ø4.8mm, 90° 495VTE Instructions for use • VITOM EAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR... -
Page 32: Electromagnetic Compatibility
Electromagnetic compatibility 10 Electromagnetic compatibility The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT). -
Page 33: Subsidiaries
KARL STORZ Endoscopy-America, Inc. E-Mail: info-be@karlstorz.com 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 424 218-8100, Fax: +1 424 218-8525 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Toll free phone: 800 421-0837 (USA only) Téléphone: +33 1 30484200, Fax: +33 1 30484201... - Page 34 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-Mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon...
- Page 35 Subsidiaries Instructions for use • VITOM EAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR...
- Page 36 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...