Page 8 / 40
The ALGO 7i is not intended for operational use by the general public. All test procedures
must be supervised or conducted by qualified personnel. In the United States of America,
Federal law restricts this device to sale by or on the order of a licensed physician.
The ALGO 7i is intended for indoor-use only and must be operated at defined environmental
conditions. ALGO 7i devices are designed for use in clinical environments, such as the well-
baby nursery, neonatal intensive care unit (NICU), mother’s bedside, audiology suite, outpatient clinic,
or doctor’s office. as well as in community settings. See also operating conditions in section 9:
Technical Specifications and information about environmental conditions regarding electromagnetic
disturbances in section 10: Electromagnetic Compatibility Information. The ALGO 7i is not intended for
use in oxygen-rich environments.
1.2.2 Contraindications
There are no known contraindications to the use of the ALGO 7i device.
1.2.3 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.
1.2.4 Side Effects
There are no known undesirable side effects for ALGO 7i devices.
See also section 8: Notes on Safety.
1.3 Performance Characteristics
The ALGO screener delivers faint click sounds at 35 or 40 dBnHL (“normal hearing level” scale) to the
baby’s ears through disposable earphones. Each click evokes a series of identifiable brain waves from
the infant’s auditory brainstem. This brain wave activity is called the ABR (auditory brainstem
response). Each click from the ALGO coupled with a response to that click is called a “sweep”.
To Next Page
Loading...
Need help?
General
