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GEBRAUCHSANWEISUNG
IMAGE1 S™ – TC 200, TC 201, TC 300, TC 301, TC 302, TC 304
INSTRUCTION MANUAL
IMAGE1 S™ – TC 200, TC 201, TC 300, TC 301, TC 302, TC 304
MANUAL DE UTILIZARE
IMAGE1 S™ – TC 200, TC 201, TC 300, TC 301, TC 302, TC 304

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Summarization of Contents

General Information
Description of the devices
Provides an overview of the IMAGE1 STM system and its modular approach.
Property rights
Details US patents protecting the product and information sources.
Safety Instructions
Explanation of warnings and cautions
Defines the meaning of Warning, Caution, and Note symbols and their importance.
General safety information
Covers risks of injury, damage, electric shock, and proper grounding.
Indications for use
Specifies the intended use of the IMAGE1 STM as a camera control unit.
Contraindications
States that no direct contraindications are known for the medical device.
Patient profile
Clarifies that the IMAGE1 STM use is not limited to specific patient profiles.
User profile (specialist physician)
Outlines the necessary medical skills and training for specialist users.
User profile (assistant)
Lists required training and skills for medical assistants using the device.
Safety precautions at the site of installation
Details safety measures related to the operating environment and potential hazards.
Safety precautions when operating the device
Emphasizes user responsibility for device safety and proper operation.
Initial Operation
Basic equipment
Lists the components included in the basic package for IMAGE1 S CONNECT®.
Unpacking the equipment
Provides instructions for safely removing and checking the device and accessories.
Preparing the device for use
Guides the user through connecting modules, power, and initial setup steps.
Installation overview (TC 200)
Shows a diagram of the system setup for the TC 200 model.
Installation overview (TC 201)
Illustrates the system configuration for the TC 201 model.
Operating Instructions
Basic information on operation
Introduces the three main menu stages: Dashboard, Live Menu, and Setup Menu.
Dashboard
Explains the Dashboard interface showing connected devices and modules.
Description of functions of the symbols used
Details the meaning of symbols displayed on the Dashboard interface.
Display
Covers settings for primary/secondary sources, display modes, and PIP layout.
Insufflation
Explains how to adjust Insufflator settings like gas, flow, and pressure.
Patient
Describes features for managing patient information and data.
Presets
Details how to save, delete, or restore preset configurations.
Setup
Provides access to the system's setup menu for configuration.
Live Menu
Explains how to navigate and use the Live Menu for camera functions.
Description of functions of the symbols used
Describes the symbols and functions within the Live Menu interface.
S-Technologies
Explains the S-Technologies like CLARA, CHROMA, SPECTRA, and Fiber Filter.
OPAL1®
Covers settings for the OPAL1® Fluorescence Imaging (FI) mode.
Light
Details how to adjust light source settings, including intensity and mode.
Setup Menu
Guides on configuring general and link-specific settings and saving presets.
Capture
Explains how to capture still images and manage storage.
Frequency
Describes how to select the image refresh rate.
3D-Ausgabequelle
Covers selecting 3D output sources and managing 2D display.
Anzeigesprache
Allows selection of the user interface language.
Tastatursprache
Enables setting the language layout for the connected keyboard.
Datum, Zeit
Facilitates setting the date, time, and display format.
Contact Information
Allows storage and retrieval of customer contact details.
Presets
Explains managing preset configurations for the system.
LINK-specific settings
Covers assigning functions to camera head/video endoscope buttons.
Patient Data Privacy
Details settings for patient data protection, including password management.
Reprocessing
General safety information
Provides critical safety information regarding reprocessing and infection risks.
Wipe-down disinfection of devices
Details the procedure for cleaning and disinfecting external surfaces of the device.
Service and Repair
Maintenance and safety check
Outlines essential maintenance and safety checks for the equipment.
Servicing and repair
Specifies that repairs must be done by authorized personnel using genuine parts.
Disposal
Provides instructions for the proper disposal of the unit as electronic waste.
Repair program
Explains the process for equipment repair, including loaner units.
Limitation of liability
Defines manufacturer liability conditions related to proper installation and use.
Warranty
Refers to standard business conditions for warranty claims and procedures.
Technical Description
Technical data
Lists detailed technical specifications for IMAGE1 S CONNECT® TC 200 and TC 201.
Technical documentation
Explains the availability of technical documents for repair purposes.
Standard compliance
Lists the IEC, UL, and CSA standards the device complies with.
Directive compliance for IMAGE1 STM
States the device's compliance with the Medical Device Directive (MDD).
Software ownership and licensing
Outlines the terms of use and licensing for software components.
Attribution Notice
Informs about open-source software usage and how to obtain source code.
Spare parts, recommended accessories
Compatible camera heads for IMAGE1 STM H3-LINK TC 300 with S technologies
Lists compatible camera heads for H3-LINK TC 300 with S technologies.
Compatible camera heads for IMAGE1 STM H3-LINK TC 300 without S technologies
Lists compatible camera heads for H3-LINK TC 300 without S technologies.
Compatible camera heads for IMAGE1 STM X-LINK TC 301 with S technologies
Lists compatible camera heads for X-LINK TC 301 with S technologies.
Compatible camera heads for IMAGE1 STM X-LINK TC 301 without S technologies
Lists compatible camera heads for X-LINK TC 301 without S technologies.
Compatible video endoscopes for IMAGE1 STM X-LINK TC 301 with S technologies
Lists compatible video endoscopes for X-LINK TC 301 with S technologies.
Compatible video endoscopes and camera heads for IMAGE1 S D3-LINK® TC 302 with S technology
Lists compatible endoscopes and camera heads for D3-LINK® TC 302.
Compatible camera heads for IMAGE1 STM 4U-LINK TC 304 with S technology
Lists compatible camera heads for 4U-LINK TC 304 with S technologies.
Recommended accessories
Lists recommended accessories for the system.
Operable SCB light sources
Lists available SCB light sources.
Operable SCB insufflators
Lists available SCB insufflators.
Compatible 3D monitors
Lists compatible 3D monitors for the system.
Information on electromagnetic compatibility (EMC)
Table 1 - Compliance level for Immunity tests
Provides compliance levels for immunity tests against electromagnetic disturbances.
Table 2 - Test levels for Proximity fields from RF wireless communications equipment
Lists test levels for proximity fields from wireless RF communication equipment.
Table 3 - Test levels for Radiated and conducted Immunity Tests
Details test levels for radiated and conducted immunity against electromagnetic fields.
Table 4 - Emission class and group
Classifies the device's electromagnetic emissions.
Table 5 - Recommended separation distances...
Provides guidance on safe separation distances from RF transmitters.
Appendix
Compatible Veterinary video endoscopes for IMAGE1 STM X-LINK TC 301 with S technologies
Lists compatible veterinary video endoscopes for the X-LINK TC 301.

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