Page 7 / 40
1
Overview
1.1
Introduction
Thank you for purchasing the ALGO 7i. This manual is your guide for safely operating and maintaining
your device.
Please read this manual carefully before using the ALGO 7i the first time. We recommend
taking particular note of the safety (see section
), intended use (see
), cleaning (see section
) and maintenance (see section
) instructions.
ALGO 7i devices are reliable, easy-to-use, and mobile medical devices. All devices provide
easy navigation via touch-screen and are intended for hearing examinations (see section
).
1.2
Intended Use
1.2.1
Intended Purpose
The ALGO® 7i Newborn Hearing Screener is a hand-held, portable hearing screener intended to
objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6
months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet
state at the time of screening. The test methodology contains:
•
stimulus delivery
•
EEG processing
•
ambient noise processing
•
PASS/REFER determination
•
screening conditions assessment
•
ability to screen ears individually, simultaneously and sequentially
•
screening test condition monitoring
ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and
other hearing health care professionals, nurses and audiologically trained personnel. It is not
intended to be operated by lay users.
Given the simple operating principle of the ALGO device, basic training with the device is sufficient for
performing screening of patients in good health. This is considered audiologically trained in this
context.
Please consider local regulations regarding the qualification requirements for performing hearing
screening.
