Important Information; Product Information; Statement Of Intended Use; Essential Performance - Verathon GlideScope Cobalt AVL Single-Use Operation & Maintenance Manual

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IMPORTANT INFORMATION

PRODUCT INFORMATION

The GlideScope
®
provides a consistently clear view of a patient's airway, enabling quick intubations. The AVL design is based
on the GlideScope GVL
of the time.
*

STATEMENT OF INTENDED USE

The GlideScope Cobalt AVL Single‑Use system is intended for use by qualified medical professionals to obtain
a clear, unobstructed view of the airway and vocal cords for medical procedures.

ESSENTIAL PERFORMANCE

Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The
essential performance of the GlideScope AVL system is to provide a clear view of the vocal cords.

STATEMENT OF PRESCRIPTION

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
This system should be used only by individuals who have been trained and authorized by a physician or used
by healthcare providers who have been trained and authorized by the institution providing patient care.

NOTICE TO ALL USERS

Verathon
recommends that all users read this manual before using the system. Failure to do so may result in
®
injury to the patient, compromise the performance of the system, and may void the system warranty.
Verathon recommends that new GlideScope users:
• Obtain instruction from a qualified individual
• Practice using the system on a mannequin before clinical use
• Acquire clinical experience on patients without airway abnormalities
* Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients.
Can J Anaesth. 2005;52(2):191‑198.
Operations & Maintenance Manual: Important Information
Cobalt AVL Single‑Use video laryngoscope system is designed for "1st Pass Success." It
®
, which is clinically proven to achieve a Cormack‑Lehane Grade I or II view 99 percent
1

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