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Storz C-MAC 8403 Series User Manual

Storz C-MAC 8403 Series
51 pages
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Instruction For Use
C-MAC
®
Video Laryngoscope 8403xxx and
Connection Cable 8403X
en

Table of Contents

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Storz C-MAC 8403 Series Specifications

General IconGeneral
TypeVideo Laryngoscope
Light SourceLED
Display TypeLCD
Battery LifeUp to 2.5 hours
Video OutputHDMI
Power SourceRechargeable battery or AC adapter
Recording CapabilityYes
Data StorageSD card
StorageSD card
CompatibilityC-MAC blades

Summary

General Information

Reading the instructions for use

Guidance on checking suitability and importance of reading instructions before use.

Scope

Specifies the valid models for these instructions for use.

Product Description

Product overview

Visual presentation of the C-MAC® video laryngoscope and accessories.

Packaging symbols

Explanation of symbols used on the product packaging.

Symbols on the product

Explanation of symbols found on the device itself.

Intended Use

Intended purpose

Describes the primary use of C-MAC® video laryngoscopes.

Contraindications

Lists conditions where the device should not be used.

Target user populations

Defines who is qualified to use the C-MAC® video laryngoscope.

Training in the operation and function of the device

Information on obtaining training for the device.

Target patient populations

Details the patient demographics suitable for the device.

User qualifications

Specifies the required qualifications for users of the device.

Safety

Serious incidents

Defines what constitutes a serious incident related to the device.

Description of warnings

Explains the meaning of different warning levels (Danger, Warning, Caution).

Notes on use

Provides general notes and requirements for using the device.

Unsterile instruments

Addresses the issue of unsterile products and infection risk.

Correct reprocessing

Emphasizes the importance of correct reprocessing for safety.

Risks from electric current

Highlights potential risks associated with electric current.

Risks due to damaged parts

Warns about potential dangers from damaged components.

Damaged products

Consequences of using damaged products.

Combination with other devices and accessories

Safety considerations when using the device with other equipment.

Damage to the instrument

Specific instructions on how to avoid damaging the instrument.

Installation and Commissioning

Visual and functional test

Procedure for checking the device's condition before use.

Initial operation

Steps for starting and using the device for the first time.

Application

Connection to the C-MAC® monitor

Instructions for connecting the laryngoscope to the C-MAC® monitor.

Connection to the C-MAC® pocket monitor

Instructions for connecting the laryngoscope to the C-MAC® pocket monitor.

Switching on the "Open-to-Intubate (OTI) displays"

Procedure for activating the OTI display on the C-MAC® PM.

Switching off the "Open to intubate" (OTI)-Displays

Procedure for deactivating the OTI display on the C-MAC® PM.

Connection to the C-Hub® II

Instructions for connecting the laryngoscope to the C-HUB® II.

Multifunctional button of the video laryngoscope

Details the functions of the blue multifunction button on the laryngoscope.

Color coding meanings for the "Blue Button" multifunction button

Explains the color signals of the multifunction button.

Single image capture

How to capture a single image using the multifunction button.

Video recording

How to start and stop video recording using the multifunction button.

Insertion of an oxygen or suction catheter (only with 8403 AX/BX/HX)

Procedure for inserting catheters into specific laryngoscope blades.

Disassembly

Instructions for safely disconnecting and disassembling the device.

Reprocessing

Overview table (worldwide, does not apply to USA and Canada)

Table summarizing reprocessing methods for worldwide use.

General warnings (worldwide, does not apply to USA and Canada)

General safety warnings for reprocessing, excluding US/Canada.

Preparation for cleaning and disinfection

Steps for preparing the device before cleaning and disinfection.

Brushing the surfaces

Specific instructions for brushing device surfaces.

Manual cleaning

Detailed steps for manual cleaning of the device.

Manual disinfection

Detailed steps for manual disinfection of the device.

Machine cleaning and disinfection

Procedures for machine-based cleaning and disinfection.

Assembly, inspection and care

Steps for reassembling, inspecting, and caring for the device.

Packaging

Guidelines for packaging the device for reprocessing.

Sterilization

Methods for sterilizing the C-MAC® video laryngoscope.

Hydrogen peroxide (H2O2) sterilization - ASP STERRAD®

Procedure for STERRAD® sterilization with hydrogen peroxide.

Hydrogen peroxide (H2O2) sterilization - STERIS® AMSCO® V-PROTM 1

Procedure for STERIS® AMSCO® V-PROTM 1 sterilization.

Ethylene oxide sterilization (EO)

Procedure for sterilization using ethylene oxide.

Chemical low-temperature sterilization with peracetic acid – STERIS® - System 1®

Procedure for low-temperature sterilization with peracetic acid.

Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E®

Procedure for low-temperature sterilization with STERIS® System 1E®.

Reprocessing limits

Information on the limits and lifespan of reprocessing methods.

Reprocessing USA and Canada

Overview table

Table summarizing reprocessing methods for USA and Canada.

General warnings (applies only to USA and Canada)

General safety warnings for reprocessing specific to USA and Canada.

Brushing the surfaces

Specific instructions for brushing device surfaces in USA/Canada.

Water Quality Requirements

Specifies required water quality for reprocessing procedures.

Pre-cleaning

Steps for pre-cleaning the device in USA/Canada.

Manual cleaning

Detailed steps for manual cleaning in USA/Canada.

Assembly, inspection and care

Steps for reassembling, inspecting, and caring for the device in USA/Canada.

Packaging

Guidelines for packaging the device for reprocessing in USA/Canada.

Sterilization

Methods for sterilizing the C-MAC® video laryngoscope in USA/Canada.

Hydrogen peroxide (H2O2) sterilization - ASP STERRAD®

Procedure for STERRAD® sterilization with hydrogen peroxide in USA/Canada.

Hydrogen peroxide (H2O2) sterilization - STERIS® AMSCO® V-PROTM

Procedure for STERIS® AMSCO® V-PROTM sterilization in USA/Canada.

Ethylene oxide sterilization (EO)

Procedure for sterilization using ethylene oxide in USA/Canada.

Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E®

Procedure for sterilization with STERIS® System 1E® in USA/Canada.

High-level disinfection

Procedures for high-level disinfection in USA/Canada.

Reprocessing limits

Information on the limits and lifespan of reprocessing methods in USA/Canada.

Service and Repair

Servicing and repair program

Details the authorized servicing and repair program for the device.

Complaint shipments

Guidelines for returning products for complaints and repairs.

Limitation of Liability

Guarantee

Electromagnetic Compatibility

Standards, Directives and Regulations

Standards, directives and regulations

Lists applicable standards, directives, and regulations for the device.

Standard compliance

Details the device's compliance with various industry standards.

Disposal

Technical Specifications

Video laryngoscope 8403 AX/BX/HX/AXC/BXC/KXC/HXP

Technical specifications for specific C-MAC® video laryngoscope models.

Video laryngoscope 8403 DXC/EXC/GXC/MXC/NXC

Technical specifications for other C-MAC® video laryngoscope models.

Operating/storage conditions for C-MAC®

Details the operating and storage conditions for the C-MAC® system.

Average life cycle

Information on the average life cycle and reprocessing cycles.

Fault Correction

Troubleshooting

Provides solutions for common problems and symptoms encountered with the device.

Accessories and Spare Parts

Accessories

Lists available accessories for the C-MAC® video laryngoscope system.

Subsidiaries

Related product manuals