Preface; Important; Medical Device Registration; Manufacturer's Responsibility - Welch Allyn AED 10 User Manual

Preface

Important!

Read this Operators Manual carefully as it contains important information concerning your
safety and the safety of others when using this Automated External Defibrillator. It is
important that you are familiar with the operation and controls before operating the
product.
Manufacturer
Product Name
Device Type

Medical Device Registration

Welch Allyn and its distributors are required by FDA medical device tracking regulations
and other national regulatory authorities to maintain records of end-users that purchase
Welch Allyn's defibrillators. Please provide us with the information requested in the
device registration card to assist us in complying with the defibrillator tracking
requirement and to enable us to contact you promptly in the unlikely event that there is a
problem with your defibrillator. If you transfer the defibrillator to another person or
company please notify us of the new owner by calling Welch Allyn at 800-289-2500 (toll-
free in USA) or 503-530-7500. Likewise, if the defibrillator is retired from use or otherwise
permanently disposed of, please call and notify us and provide the date of retirement or
disposition.

Manufacturer's Responsibility

Welch Allyn Protocol, Inc. is responsible for the safety, reliability, and performance of the
Welch Allyn AED 10, only if the following conditions are met:
• Assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorized by Welch Allyn Protocol, Inc.
• The Welch Allyn AED 10 equipment is used in accordance with the instructions
for use.

User's Responsibility

The Welch Allyn AED 10 is intended for use by personnel who are authorized by a
physician/medical director, and who have the following training and skills:
Welch Allyn Protocol, Inc.
Welch Allyn AED 10 (and JumpStart)
Automated External Defibrillator
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