Description

The AIRWAYS GUEDEL is an essential device for healthcare professionals, designed to ensure airway patency in unconscious or anesthetized patients. Its primary function is to prevent the tongue from obstructing the airway, making it invaluable in emergency, anesthesia, and intensive care settings.

Key Features

• One-Piece Design: Enhances safety by eliminating the risk of loose components.
• Bite-Resistant: Rigid body resists distortion, maintaining functionality even under involuntary biting.
• Soft Tip: Minimizes trauma to oral tissues, reducing the risk of dental injury.
• Anatomical Shape: Curved to follow the natural contour of the oropharynx, ensuring easy insertion and comfort.
• Hollow Lumen: Facilitates efficient airflow and allows for effective suctioning.

Sizing and Identification

The device features color-coded sizing, compliant with ISO 5364:2016 standards, allowing for quick and accurate size identification. This feature is crucial for rapid response in critical situations.

Material and Safety

Constructed from latex-free, DEHP-free materials, the AIRWAYS GUEDEL is made from medical-grade LDPE and HDPE/Polypropylene. It is available in both sterile and non-sterile options, each supplied in individual pouches for single use, ensuring hygiene and preventing cross-contamination.

Intended Use

Suitable for a wide range of patients, from pediatric to adult, the device is intended for use in:

• Emergency resuscitation
• Anesthesia
• Intensive care
• Pre-hospital care

It also serves as a bite block in intubated patients, providing additional functionality.

Contraindications

The device should not be used in conscious patients with an intact gag reflex or those with specific conditions such as nasal fractures or active nasal bleeding.

Instructions for Use

Proper sizing is determined by measuring from the corner of the mouth to the jaw angle. Insertion involves a specific technique to ensure correct placement and effectiveness. Users are advised to confirm airway patency post-insertion and to remove the device if the patient exhibits a gag reflex.

Complications and Warnings

Potential complications include vomiting, aspiration, and mucosal injury if improperly used. The device should not be reused, and any damaged packaging should be avoided to prevent infection risks.

Compliance and Standards

The AIRWAYS GUEDEL complies with relevant ISO standards for biocompatibility and design, ensuring it meets high safety and performance criteria. It is intended for use by trained healthcare professionals and should be stored appropriately to maintain its integrity over a typical shelf life of five years.

This comprehensive design and adherence to international standards make the AIRWAYS GUEDEL a reliable choice for effective airway management in critical healthcare environments.