natus ALGO 3i User Manual

I. Intended Use
ALGO
®
3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08/05/2020
5
I. Intended Use
The ALGO
®
3i Newborn Hearing Screener is a portable, noninvasive device for screening the
hearing of infants between the ages of 34 weeks corrected gestational age and six months. The
screener uses Natus’ AABR
®
technology. Babies should be well enough for hospital discharge,
and should be asleep or in a quiet state at the time of screening.
The ALGO 3i screener is simple to operate and does not require special technical skills or
interpretation of results. Basic training with the equipment is sufficient to learn how to screen
infants correctly. A typical screening can be completed in 15 minutes or less in any clinical
environment (i.e. well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic,
or doctor’s office).
Exclusion Criteria
The following criteria should be used to exclude an infant from screening with the Natus ALGO
hearing screeners.
 infants not between 34 weeks
gestational and 6 months of age
 infants on ventilators or in incubators
 infants on CNS (central nervous
system) stimulants
 infants receiving ototoxic medications
 infants with compromised skin or
jaundice
Such infants may be screened once they
are 34 weeks gestational age, and healthy
enough for discharge from the hospital,
but standard-of-care protocols should be
followed as some of these conditions may
be associated with delayed onset hearing
loss.
 infants exhibiting cranio-facial head
abnormalities, including structural
abnormality of the outer, middle, or
inner ear
 infants with known or suspected
neurological conditions
Such infants should not be screened with
the ALGO screener, as screening results
may be misleading. Such infants require a
comprehensive medical, audiological, and
neurological assessment performed by
qualified professionals.
 infants in an agitated state
Perform the ALGO screening when the
infant has settled down to ensure accurate
results.
Safety Information
This manual presents two types of precautionary information. The two types of statements carry equal
weight; that is, they are of equal importance to the safe and effective use of the device. Each statement is
categorized by using an introductory word in boldface as follows:
Warning! Identifies conditions or practices which might present possible injury or danger to the infant
and/or user.
Caution: Indicates an instruction which must be followed to avoid damage to the screening device
and/or prevent erroneous screening results.
Other explanatory information is highlighted with the word Note. Information of this category is
not considered precautionary.

natus ALGO 3i Specifications

General

Brand	natus
Model	ALGO 3i
Category	Medical Equipment
Language	English