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Summarization of Contents
Understanding General Information
Importance of Reading Instructions
Crucial to follow instructions to prevent injury and damage. Adhere to all safety notes and warnings.
Using Combinable Products Safely
Follow instructions for combined products to prevent injury and damage. Adhere to all safety notes and warnings.
Manual Scope and Product List
Defines the products and article numbers covered by this instruction manual.
Interpreting Warning Messages
Explains the meaning of warning symbols like WARNING, CAUTION, and ATTENTION for safety.
Normal Use and Application
Product Intended Use
Describes the purpose of the sheaths for creating channels during urological procedures.
Medical Indications for Use
Lists specific urological conditions for which the instruments are indicated.
Contraindications for Use
Details conditions where the instruments should not be used, including patient health.
Qualified User Requirements
Specifies that only qualified medical professionals should use the device.
Key Safety Precautions
Reporting Serious Incidents
Defines 'serious incident' per MDR and outlines notification procedures.
Handling Non-Sterile Products
Warns that the product is non-sterile and requires reprocessing before use.
Guidelines for Correct Handling
Provides guidelines for safe handling, inspection, and use to prevent injury.
Avoiding Damaged Products
Instructs users to check for damage before use and not to use damaged products.
Product Description and Components
Product Overview
Illustrates and names the cystoscope sheaths and their associated components.
Compatible Component Combinations
Lists compatible sheaths, obturators, bridges, and telescopes for creating instrument sets.
Storage and Transport Conditions
Specifies that no special transport or storage conditions are required for the product.
Explanation of Packaging Symbols
Explains the meaning of various symbols found on the product packaging.
Preparation and Assembly Procedures
Product Unpacking and Initial Inspection
Details steps for carefully removing the product from packaging and checking for damage.
Pre-Use Product Testing
Outlines procedures for inspecting the product for contamination, working order, and assembly.
Assembling Product Components
Describes how to combine different components like sheaths, obturators, and telescopes for use.
Product Disassembly Guide
Steps for Product Disassembly
Provides step-by-step instructions on how to take apart the cystoscope sheath assembly.
Maintenance, Repairs, and Disposal
Authorized Product Repairs
States that repairs must be done by KARL STORZ or authorized personnel.
Safe Product Disposal
Outlines necessary measures for product disposal, including decontamination and regulations.
Accessories and Spare Parts List
Spare Parts Identification
Lists available spare parts for the products with their corresponding order numbers.
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