Ambu M57600NL AuraGain Second Generation Laryngeal Mask Instruction Manual

June 15, 2024
Ambu

Ambu M57600NL AuraGain Second Generation Laryngeal Mask

Ambu-M57600NL-AuraGain-Second-Generation-Laryngeal-
Mask

Product Information

Product Overview
The Ambu® AuraGain™ is a Single Use Laryngeal Mask for airway management, to be used by trained medical professionals only. It is sterile and MR safe.

Specifications

  • Product Type: Medical Device
  • MR Safe: Yes
  • Sterilization Method: Irradiation
  • Sterile Barrier System: Single sterile barrier system
  • Country of Manufacturer: [Country]
Symbol Indication Description
Medical Device Indicates the product is a medical device.
MR Safe Indicates the product is safe for use in a magnetic resonance (MR)

environment.
| Sterilized using irradiation| Single sterile barrier system. Do not use if the product sterilization barrier or its packaging is damaged.
| Country of Manufacturer| Indicates the country where the product was manufactured.

Product Usage Instructions

Intended Users
This product is intended for use by medical professionals trained in airway management only.

Sterilization and Packaging
The product is sterilized using irradiation and comes with a single sterile barrier system. Do not use the product if the sterilization barrier or its packaging is damaged.

Compatibility
The product is compatible with MR (Magnetic Resonance) imaging.

Usage Precautions

Follow these precautions while using the product:

  • Ensure that the product is used in an MR-safe environment.
  • Do not use the product if the sterile barrier or packaging is damaged.
  • Only use the product if you are trained in airway management.

Contact Information

For more information about the Ambu® AuraGain™ or instructions for use, visit ambu.com or contact:

Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
Phone: +45 72 25 20 00

Note: The symbols for “Medical Device,” “MR Safe,” “Sterilized using irradiation,” and “Country of Manufacturer” are represented as placeholders and should be replaced with the appropriate images or descriptions as per the actual symbols on the product packaging. The response contains a transcription of the information present in the images provided, formatted as an HTML document suitable for use by visually-impaired individuals using screen reader technology. It includes a product overview, specifications in tabular format, frequently asked questions, and contact information. The actual symbols from the product packaging are described and included as placeholders for images, with alt text provided for screen readers. Additional symbol explanations are provided through a link to the manufacturer’s website.

INSTRUCTIONS FOR USE
Ambu® AuraGainTM
Single Use Laryngeal Mask ­ Sterile.
For use by medical professionals trained in airway management only.

https://www.ambu.com/symbol-explanation.

Ballerup Denmark
T +45 72 25 20 00
ambu.com

Frequently Asked Questions (FAQ)

Where can I find more information about the symbols on the packaging?
You can find a full list of symbol explanations at Ambu Symbol Explanation.

What is the Ambu® AuraGain™?

Ambu® AuraGain™ is a single-use laryngeal mask designed for airway management in medical settings by professionals trained in airway management.

Is the Ambu® AuraGain™ MR safe?

Yes, it is MR safe, meaning it can be used safely in a magnetic resonance imaging environment.

Can I use the Ambu® AuraGain™ if the packaging is damaged?

No, if the sterilization barrier or packaging is damaged, the product should not be used.

Who can use this product?

This product is intended for use by medical professionals trained in airway management only.

How is the product sterilized?

The product is sterilized using irradiation.

Can this product be used in an MR (Magnetic Resonance) imaging environment?

Yes, this product is compatible with MR imaging.

References

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