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General| Manufacturer | Karl Storz |
|---|---|
| Light Source | LED |
| Battery Type | Lithium-ion |
| Category | Video Laryngoscope |
| Series | C-MAC 8401 |
| Display Type | LCD |
| Data Storage | SD card slot |
| Power Source | Battery |
| Camera Head | Integrated |
Guidance on how to properly read and use the manual for safety and correct operation.
Defines the models and systems for which these instructions for use are valid.
Specifies the primary purpose and application of the C-MAC® video laryngoscope system.
Lists situations or conditions where the use of the product is not recommended or is forbidden.
Identifies the qualified medical professionals who are intended to use the device.
Details the required skills, training, and medical qualifications for users.
Outlines essential safety measures and procedures specific to the laryngoscope's operation.
Details safety considerations and testing specific to the C-MAC® PM.
Directs users to training resources and personnel for proper device operation.
Describes the characteristics of patients suitable for treatment with the device.
Defines what constitutes a serious incident according to medical device regulations.
Explains the meaning of WARNING, CAUTION, and ATTENTION signals for risk assessment.
Highlights the risk of infection from unsterile products and necessary precautions.
Emphasizes the importance of correct reprocessing to prevent infection risks.
Details potential risks associated with using damaged components of the instrument.
Provides guidelines on the safe combination of the device with other medical equipment and accessories.
Specifies methods that must not be used for cleaning or sterilizing the instrument.
Warns about the risk of injury from damaged products and inspection requirements.
Informs about the potential for nickel allergy due to the composition of the laryngoscope blades.
Presents a visual overview of the C-MAC® video laryngoscope system components.
Explains the meaning of various symbols found on the product packaging.
Explains the meaning of symbols directly present on the medical device itself.
Provides instructions and safety warnings for charging the C-MAC® PM unit.
Details the necessary visual and functional checks before and after device use.
Step-by-step instructions for operating the C-MAC® PM with the laryngoscope.
Explains how to manage the device's battery power and charging status.
Instructions for inserting and activating the electronic module into the laryngoscope.
Describes the automatic focus adjustment feature for the video laryngoscope image.
Explains the functions of the video recording and single image capture keys.
Refers to monitor controls and their functions, directing to separate instructions.
Details the process for inserting catheters using specific laryngoscope blade models.
Provides instructions on how to safely disconnect and disassemble the system components.
Describes the optional protective bag for mobile use of the C-MAC® system.
Outlines the procedures and precautions for cleaning and disinfecting the device.
Provides step-by-step guidance for manual cleaning and disinfection processes.
Details the process for cleaning and disinfecting the device using a washer-disinfector.
Presents a comparative table of suitable and unsuitable methods for cleaning, disinfection, and sterilization.
Specifies the approved methods and warnings for sterilizing the C-MAC® system components.
Explains the procedures for servicing and repairing defective instruments.
Outlines requirements for returning products for complaints, focusing on hygiene.
Lists applicable medical device directives, standards, and compliance requirements.
Confirms compliance with specific international standards like IEC 60601 and others.
Offers solutions for common symptoms and possible causes of device malfunction.
Lists and describes optional accessories available for the C-MAC® system.
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