Related Manuals for Karl Storz 11583A
Summarization of Contents
Product Information and Usage Guidelines
Suitability and Confidence
Check product suitability for procedures and acknowledge brand confidence.
Manual Purpose and Scope
Manual aids in correct use, cleaning, and sterilization of miniature endoscopes.
Continuous Product Development
KARL STORZ continuously develops products; changes in form, equipment, or technology are possible.
General Safety Warnings and Cautions
Understanding Warning Symbols
Explains the meaning of Warning, Caution, and Note symbols for safe operation.
Initial Safety Checks and Instructions
Covers reading the manual, pre-use checks, and defibrillator safety.
Operational Safety Warnings
Application Suitability and Combination Safety
Verifies equipment condition, safe combination of devices, and potential risks.
Light Intensity and Functional Defect Risks
Warns about high heat from light and immediate action for functional defects during use.
Reprocessing and Sterilization Safety
Cleaning and Sterilization Cautions
Cautions against ultrasound baths, saline solutions, and proper autoclave marking for steam sterilization.
Temperature and Autoclave Guidelines
Specifies temperature limits for non-autoclavable items and steam sterilization requirements.
Handling and Accessory Safety Warnings
Accessory and Probe Safety
Use only KARL STORZ accessories and flexible tip guide probes to prevent damage.
User Qualification and Insertion Precautions
Emphasizes qualified users and careful instrument insertion to avoid injury.
Instrument Integrity and Infection Control Warnings
Combination Device Safety and Integrity
Risks associated with device combinations and ensuring instrument integrity.
Handling Damaged or Incomplete Instruments
Warns about malfunctions from damaged or incomplete instruments and the need for inspection.
Operational and Material Risk Warnings
Shipment and Reprocessing Infection Risks
Addresses infection risks during shipment and from non-validated reprocessing procedures.
Risk of Injury from Excessive Force
Warns against overloading the instrument to prevent breakage, deformation, or malfunction.
Endoscope Use and Maintenance Warnings
Adherence to Medical Procedures
Instruments must be used according to recognized medical rules and procedures for endoscopy.
Light Energy Burn and Glare Hazards
Warns about heat hazards from light energy and the danger of glare from the light source.
Defective Telescope and Surface Cleanliness
Addresses risks from defective telescopes and the importance of cleaning surfaces before sterilization.
Additional Handling and Shipment Cautions
Shipment Infection Prevention
Procedures to prevent infection during instrument shipment, including cleaning and sterilization.
Notes on Application, Storage, and Functions
Reminders on following manual conditions, cleaning optics, and preparing for function loss.
Warranty and Disposal Notes
Notes on warranty exclusions for incorrect operation and following disposal regulations.
Intended Use and Safety Precautions
Indications and Contraindications
Specifies intended use for salivary gland diseases and lists contraindications for use.
Adherence to Endoscopic Standards
Miniature endoscopes must be used according to recognized medical rules and procedures of endoscopy.
User Qualification and Manual Scope
Qualified Personnel Requirement
Only use by persons with appropriate medical qualification and endoscopic technique knowledge.
Manual's Instructional Purpose
Manual instructs on handling, cleaning, sterilization, not endoscopic technique.
Unpacking and Initial Use
Shipment Inspection
Check for missing items and shipping damage; report complaints immediately.
Initial Sterilization Requirement
Devices are delivered unsterilized and must be cleaned, disinfected, and sterilized before initial and subsequent use.
Handling Miniature Endoscopes: General Precautions
Optical System Sensitivity
Optical components are sensitive and require careful handling for longevity and quality.
Proper Gripping Techniques
Hold by eyepiece/handle, avoid sharp instruments on shaft, and never grasp by one part only.
Careful Placement and Storage
Place carefully, protect distal end from impact, store in protective sleeves if available.
Handling Miniature Endoscopes: Specific Precautions
Distal End System Integrity
Avoid bending the distal end to prevent lens system breakage.
Autoclave Marking and Temperature Limits
Only 'AUTOCLAVE' marked devices can be steam sterilized; others have temperature limits.
Channel Cleaning and Protection
Do not force cleaning tools, protect distal end lens, and avoid storing with sharp objects.
Handling Miniature Endoscopes: Light and Operation
Light Intensity Adjustment
Reduce light source intensity to optimal level to prevent heat emission and burns.
Sterile Cover Cloth Caution
Avoid placing fiberoptic cable or distal tip on sterile cover cloths to prevent burns.
Handling Miniature Endoscopes: Instrument Channel Use
Adherence to Medical Procedures
Handle endoscopes according to recognized medical rules and procedures for endoscopy.
Accessory Compatibility and Insertion
Use specific accessories, ensure correct length/diameter, and contact for questions.
Insertion Resistance Handling
If resistance is high during insertion, do not force; retract, lubricate, and re-insert.
Handling Miniature Endoscopes: Specific Procedures
Jaw Instrument Insertion and Retraction
Insert and retract jaw instruments with jaws closed; open only when clear of channel.
Grasping Forceps Stone Extraction
Remove stone by removing the entire endoscope, not through the channel.
Working/Irrigation Channel Rinsing
Rinse channels immediately after use with a syringe and cleaning solution/distilled water.
Handling Miniature Endoscopes: Post-Intervention Cleaning
Immediate Cleaning Post-Intervention
Clean immediately after intervention to ensure disinfection and prevent channel blockage.
Recommended Accessories Only
Use only KARL STORZ recommended accessories to prevent endoscope damage.
Preparation and Instrumentation
Pre-Use Inspection and Cleaning
Inspect for external damage, check eyepiece clarity, clean lenses if necessary.
Connecting Light Sources
Connect fiberoptic light cable to inlet piece and switch on supply units.
Instrument Insertion
Instruments can be inserted into the working channel as required.
General Reprocessing Warnings and Cautions
Infection Risk from Improper Reprocessing
Improper reprocessing exposes patients/users to infection and device malfunction risks.
Guidelines for Contaminated Devices
Follow safety guidelines when working on contaminated medical devices.
Specific Reprocessing Cautions
Cautions against ultrasound baths, saline solutions, and material stress from frequent reprocessing method changes.
Detailed Reprocessing Steps
Accessories for Reprocessing
Lists required accessories like surface and lumina cleaning brushes and cautions against metal brushes.
Disassembly for Cleaning
Separate device into individual components before cleaning and disinfection.
Bedside Pre-Cleaning and Channel Cleaning
Immediate wiping with enzymatic cleaner, and caution for small channel cleaning.
Manual Cleaning and Rinsing Procedures
Detailed steps for manual cleaning, rinsing, brushing channels, and flushing with syringes.
Assembly, Inspection, and Care
Visually inspect cleaned devices for cleanliness, completeness, and damage; remove stubborn deposits with paste.
Sterilization Methods and Guidelines
Packaging Systems
Use only standardized and approved packaging materials or systems.
Steam Sterilization Procedures
Outlines steam sterilization parameters and warnings, including autoclave marking and metal contact.
Hydrogen Peroxide Sterilization (STERIS/STERRAD)
Details STERIS V-PRO and STERRAD sterilization methods, restrictions, and notes.
Ethylene Oxide Sterilization (EO)
Describes EO sterilization parameters, procedure, and warnings regarding assembly and airing times.
Compliance and Liability
Standard Compliance and Liability
Outlines standard compliance, limitation of liability based on proper use and authorized service.
Warranty Information
Details warranty terms and the requirement to return devices to local subsidiaries for service.
CE Directive Compliance
Medical devices bear CE mark according to Medical Device Directive (MDD) 93/42/EEC.
Servicing, Repair, and Disposal
Disposal of Medical Devices
Dispose of devices according to national laws and regulations; no special measures needed.
Repair Program and Authorization
Describes individual repair needs for endoscopes and contact information for authorization.
Important Repair Information
Emphasizes cleaning/sterilization before repair and warranty voidance for unauthorized modifications.
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