Table of Contents
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Table of Contents
Related Manuals for Storz TH110
Summarization of Contents
General Information
Read the Instructions for Use
Importance of following instructions for user safety and product integrity.
Compatible Product Instructions
Importance of following instructions for compatible products for user safety.
Scope of Instruction Manual
Specifies the product names and item numbers covered by the manual.
Document Symbols and Signs
Explains the meaning of practical tips and action indicators used in the document.
Warning Message Definitions
Defines danger levels (WARNING, CAUTION, NOTICE) and their implications.
Normal Use
Intended Use
Describes the purpose and function of camera heads in diagnostic/surgical procedures.
Indications for Use
Explains the use of camera heads with accessories for displaying endoscopic fields.
Contraindications
States that no direct contraindications are known for the device.
Target User Populations
Identifies qualified doctors and medical assistants as intended users.
Patient Population
States that there are no restrictions on patient groups for this product.
Safety and Warnings
Serious Incidents
Defines what constitutes a 'serious incident' and reporting requirements.
Handling and Product Testing
Guidelines for proper handling, qualification, and product checks before use.
Combination with Other Components
Rules for combining the product with other medical devices and components.
Electrical Current Dangers
Warns about electric shock hazards from improper power supply and HF device contact.
Hot Component Hazards
Alerts to burns from hot components due to high light intensity.
High Light Intensity Risks
Warns about permanent eye damage and tissue heating from high light output.
HF Instrument Injury Risk
Highlights risks from HF instruments and contact with the product.
Product Failure Preparedness
Advises having replacement products or alternative techniques ready.
Product Description
Product Overview
Shows and labels the IMAGE1 S HX Camera Heads (TH110) and (TH111).
Possible Combinations
Lists compatible camera control units (CCU) and link modules for the camera heads.
Technical Data
Provides specifications like image sensor, format, refresh rate, focal length, dimensions, and weight.
Symbols on the Packaging
Explains common symbols found on product packaging, like Manufacturer, MD, REF, SN, QTY, UDI.
Ambient Conditions
Details storage/transport and operating conditions for temperature and humidity.
Preparation
Unpacking the Product
Steps for carefully removing, checking for damage, and reporting issues with the product.
Assembling the Product
Instructions for connecting the camera head to an endoscope eyepiece.
Connecting the Light Cable
Step-by-step guide on how to connect the light cable to the camera head.
Application
Adjusting the Focus
Instructions on how to adjust image sharpness using the focus ring on the camera heads.
Maintenance, Servicing, Repairs, and Disposal
Repairs to the Product
Outlines that repairs must be done by authorized personnel and decontamination requirements.
Disposing of the Product
Provides guidance on proper disposal of the product according to WEEE directive.
Accessories and Spare Parts
Accessories
Lists available accessories for the camera heads with their order numbers.
Electromagnetic Compatibility
General Notes on Operating Environment
Discusses suitability for healthcare settings and potential issues in residential environments.
Table 1 – Immunity Test Compliance
Details immunity test levels and electromagnetic environment guidelines for the product.
Table 2 – HF Wireless Equipment Immunity Tests
Presents test levels for HF wireless communication equipment immunity.
Table 3 – Radiated and Conducted Immunity Tests
Details test levels for radiated and conducted immunity for the product.
Table 4 – Emission Class and Group
Specifies emission class and group for the product and its operating environment.
Table 5 – Separation Distances for HF Devices
Provides recommended separation distances for HF devices to prevent interference.
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