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Storz 11001 BN1 User Manual

Storz 11001 BN1
76 pages
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Fiberskope
Serien 110xx ..., 111xx ..., 112xx ..., 113xx..., 13304C*)
Fiberscopes
Series 110xx ..., 111xx ..., 112xx ..., 113xx..., 13304C*)
Fibroscopios
Series 110xx ..., 111xx ..., 112xx ..., 113xx..., 13304C*)

Table of Contents

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Storz 11001 BN1 Specifications

General IconGeneral
BrandStorz
Model11001 BN1
CategoryMedical Equipment
LanguageEnglish

Summary

Important Information and Sterilization Methods

User Note on Broncho- and Intubation-Fiberscopes

Important note for users regarding material compatibility and sterilization systems.

Validated Sterilization Methods Overview

Lists validated sterilization methods including STERRAD, STERIS, and Ethylene Oxide.

Reference to Detailed Instrument Care Instructions

Reference to detailed instructions for cleaning, disinfection, care, and sterilization of instruments.

Unit Illustrations and Component Identification

DCI® Fiberscope Illustration

Illustration of the DCI® fiberscope model.

PDD Fiberscope Illustration

Illustration of the PDD fiberscope model.

OPT Fiberscope Illustration

Illustration of the OPT fiberscope model.

Controls and Components Overview

Components and Connectors Overview

Description of various components, connectors, and their functions, including valves and adapters.

Testing, Cleaning, and Camera System Accessories

Details on leakage testers, cleaning adapters, mouthpieces, camera components, and light cables.

Control Elements and Mechanisms

Identification and description of control elements like focusing rings, PDD filter changers, and locking mechanisms.

Intended Use and Safety Precautions

Indications and Contraindications

Defines the intended applications and lists contraindications for using the fiberscopes.

General Safety Precautions for Fiberscope Use

Outlines essential safety precautions to ensure the proper and safe use of fiberscopes.

User Qualification and Responsibilities

User Qualification Requirements

Specifies the required medical qualification and familiarity with endoscopic techniques for users.

Warnings and Cautions for Safe Operation

General Safety Alerts and Procedures

Covers types of alerts, pre-use checks, and general operational safety guidelines.

Specific Handling and Sterilization Precautions

Details handling, sterilization prohibitions, temperature limits, chemical compatibility, and accessory usage.

Operational Limitations and Documentation References

Covers guarantee disclaimers, disposal notes, limitations, and references to other manuals.

Unpacking and Initial Setup

Initial Delivery Inspection and Content Check

Instructions to check the delivery for completeness and evidence of shipping damage.

Basic Equipment and Accessories List

Lists the basic equipment and accessories included with the fiberscopes.

Initial Operation and Component Assembly

Sterility Warning Before First Use

Crucial warning about the fiberscope not being sterile and requiring cleaning, disinfection, and sterilization.

Component Assembly Procedures

Step-by-step guides for fitting the suction valve, tube holder, and lip valve.

Handling the Fiberscopes for Longevity

General Handling and Storage Guidelines

Provides essential guidelines for careful handling, storage, and protection of fiberscopes.

Documentation and Notes

Notes regarding fiber bundle condition documentation and specific user guides.

Using the Fiberscopes for Procedures

General Operation and Connection Procedures

Covers proper operation, light source adjustment, aseptic conditions, and basic connection procedures.

Specific Component and Accessory Usage

Details usage warnings for HF/Laser probes, sharp accessories, and stone baskets.

Maintenance and Testing Requirements

Outlines immediate cleaning, leakage testing, accessory compatibility, and channel limitations.

Fiberscope Preparation Procedures

Pre-Use Inspection and System Checks

Covers pre-use checks for damage, leakage, supply connections, and system warnings.

Operational Controls and Mechanisms

Details operation of suction, insufflation, tip control, locking mechanism, and focusing.

Channel and Special Model Preparation

Instructions for instrument channel use and preparation specific to PDD models.

DCI® Fiberscope with Camera Operation

Assembly and Component Connection

Step-by-step guide for assembling the DCI® fiberscope with camera, including light cable and focusing.

Camera Control Unit Operation

Describes camera control unit operation and references further functions in its manual.

DIN Eyepiece Connection to DCI® Fiberscope

Assembly and Disassembly Procedures

Instructions for assembling and disassembling the DIN eyepiece adapter with the DCI® fiberscope and camera.

Supply Unit Manual Reference

Emphasizes observing instruction manuals for all used supply units.

DCI® Camera to DIN Eyepiece Connection

Assembly and Disassembly Procedures

Steps for assembling the DCI® camera with DIN eyepiece adapter, including focusing and coupling.

Supply Unit Manual Reference and Warnings

Emphasizes observing supply unit manuals and warns against over-tightening the instrument coupling.

Cleaning, Disinfection, and Sterilization Protocols

General Cleaning and Disinfection Guidelines

Covers cleaning manual reference, approved chemicals, and warnings against improper methods.

Sterilization Prerequisites and Process Controls

Details sterilization prerequisites, process controls, and material wear considerations.

Preparation Overview 1 - German

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 1 - English

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 1 - Spanish

Limpieza previa suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 2 - German

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 2 - English

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 2 - Spanish

Limpieza previa suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 3 - German

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 3 - English

Preliminary cleaning suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preparation Overview 3 - Spanish

Limpieza previa suitability

Indicates suitability of preliminary cleaning procedures for various products.

Preliminary Cleaning Procedures

Initial Cleaning and Leak Testing Procedures

Covers initial soiling removal, leakproof checks, tester connection, and inflation notes.

Eyepiece Preparation and Infection Control

Details eyepiece sealing for sterilization and critical infection risk warnings for shipping.

Manual Preparation Procedures

Disassembly and Component Preparation

Guides for disassembly, part preparation, and assembly of components like suction valve inserts.

Cleaning Procedures and Warnings

Details manual cleaning steps, paste usage, drying, disinfection, and associated warnings.

Storage Guidelines and Limitations

Provides guidelines for storing instruments after preparation and notes on channel-less fiberscopes.

Machine Preparation Procedures

Machine Connection and Program Selection

Covers connecting to machines, program selection, and temperature limits during machine preparation.

Pre-Preparation Checks and Adapter Handling

Details leak checks, adapter connections, dismantling, and risks associated with adapters.

Post-Preparation Storage Guidelines

Provides guidelines for storing instruments after machine preparation and notes on channel-less fiberscopes.

Gas and Plasma Sterilization Methods

Introduction to Sterilization Methods and Regulations

Introduces sterilization methods, regulations, packaging requirements, and pressure compensation.

Sterilization Specifics and Residue Limits

Details airing times, ETO residue limits, immediate use after sterilization, and plasma limits.

Accessories: Flexible Forceps, Snares, and Cannulas

Flexible Forceps Preparation and Sterilization

Instructions for preparing, cleaning, disinfecting, and sterilizing flexible forceps.

Snares and Cannula Preparation

Guides for preparing papillotome/polypectomy snares and flexible injection cannulas.

Normative Information and Service Policies

Servicing, Repair, and Liability Limitations

Covers policies on servicing, repair, liability limitations, and warranty terms.

Directive Compliance

Confirms compliance with Medical Device Directive (MDD) 93/42/EEC and CE marking.

Repair and Replacement Program Details

Repair Service and Contacts

Details the repair service, replacement warehouse, and contact information for repairs.

Shipping and Warranty Compliance

Provides important information on infection prevention for shipping and warranty voidance due to unauthorized repairs.

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