natus ALGO 3i User manual

ALGO®3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08/05/2020
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Instructions for Use

ALGO®3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08/05/2020
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Caution: Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
AABR, ALGO, and Natus are registered trademarks of
Natus Medical Incorporated
SpeedScreen and SoftClip are trademarks of Natus Medical
Incorporated
NuPrep is a trademark of D.O. Weaver & Co.
Windows and Windows Explorer are registered trademarks
of Microsoft Corporation.
Copyright © 2020 by Natus Medical Incorporated: All
content within this document is owned by Natus Medical
Incorporated
Distribution of contents to persons other than customers of
Natus is strictly prohibited
Reproduction of any part of this document without the
expressed written consent of Natus is strictly prohibited
Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 USA
Toll-free: [phone]
Telephone: [phone]
Fax: [phone]
E-mail: [e-mail]
Global Sales & Support: 1-800-303-0306 Fax: [phone]
www.natus.com
Technical Contact Information: In the United States, contact Natus Technical Service at [phone]
or [phone]. Outside the United States, please contact your authorized service representative.
© 2020 Natus Medical Incorporated
Natus Manufacturing Limited
IDA Business Park
Gort Co. Galway, Ireland
Tel.: [phone]
Website: natus.com

Contents
ALGO®3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08/05/2020
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Contents
I. Intended Use.......................................................................................................... 5
Exclusion Criteria..............................................................................................................................5
Safety Information.............................................................................................................................5
II. Overview of the ALGO Screening Technology................................................... 8
III. Screening Device and Components.................................................................... 9
Device Components..........................................................................................................................9
IV. User Interface Navigation................................................................................... 11
Description of Keys.........................................................................................................................11
Scrolling/Selecting in the ALGO 3i Screener ...............................................................................12
Data entry in the ALGO 3i Device..................................................................................................13
V. ALGO 3i Screening Procedure........................................................................... 16
Overview of Screening Procedure.................................................................................................16
Detailed Instructions of Screening Procedure.............................................................................17
Step 1: Power-On and Start-Up/Warnings....................................................................................17
Step 2: Observe MainMenu ............................................................................................................18
Step 3: Select screening mode......................................................................................................18
Step 4: Prepare baby and attach supplies....................................................................................19
Step 5: Select Screening Parameters............................................................................................22
Step 6: Start Screening/Check Impedances.................................................................................23
Step 7: Monitor Screening in Progress.........................................................................................24
Step 8: Observe screening complete............................................................................................26
Step 9: Remove and discard supplies ..........................................................................................26
Step 10: Return to MainMenu/Disposition screening record......................................................26
Step 11: Power Off ..........................................................................................................................27
Step 12: Clean Preamp3i and ATA3i cables before and/or after use.........................................27
SpeedScreen mode (alternative to Steps 3 to 6 or ScreenBaby mode) ....................................27
Information about SpeedScreen and Screening Complete...............................................................29
Printing (or Exporting) a Record Immediately after Screening..................................................29
VI. Baby Preparation ................................................................................................ 32
Skin Prepping Techniques.............................................................................................................32

Contents
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Prepping Tips ..................................................................................................................................32
VII. Data Management ............................................................................................... 34
Overview of the DataManagement Window..................................................................................34
To select records.............................................................................................................................34
To print screening records.............................................................................................................36
To print a screening record directly after screening:.........................................................................36
To print ALL screening records:........................................................................................................37
To print SELECTED screening records: ...........................................................................................37
Data Export to a PC.........................................................................................................................37
To delete screening records ..........................................................................................................38
Automatic deletion of a screening record..........................................................................................38
Manual deletion of screening records...............................................................................................38
To delete SELECTED screening records..........................................................................................39
To delete ALL screening records......................................................................................................39
VIII. Equipment Check................................................................................................ 40
Technical Verification using ALGO Check Kit .............................................................................41
Impedance Check: Connect all three sensor clips into the Check Kit. .............................................41
Acoustic Check: Connect ATA transducers into the Check Kit.........................................................41
Artifact Check: Connect only the sensor clips into the Check Kit.....................................................41
IX. Reference............................................................................................................. 42
Cleaning the Device and Cables.......................................................................................................42
Error Messages.................................................................................................................................43
Safety and Compliance Information..................................................................................................43
Symbols Used...................................................................................................................................44
Specifications ....................................................................................................................................45
Appendix A: Electromagnetic Compatibility (EMC)...........................................................................46

I. Intended Use
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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.

I. Intended Use
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Read all sections of the user manual prior to using the ALGO 3i screener to screen infant
hearing. Inspect the ALGO 3i device and cables for any damage prior to screening an infant. Do
not use if damage is present. Contact Natus Technical Service or an authorized service
representative.
See Chapter IX for a listing of safety symbols used.
Warning: This equipment is not protected from a cardiac defibrillator discharge. Using a
defibrillator while a patient is connected to the system equipment may permanently damage the
equipment.
Warning: Do not use the screener if you suspect it is not functioning properly or if any parts appear
damaged. Please call Natus Technical Service or your authorized service provider for assistance.
Warning! Ensure that the ALGO 3i screener is securely positioned on the bassinet, flat surface, or
mounting pole (option).
Warning! Ensure that the ATA and preamp cables are positioned to prevent cable damage and
obstruction of user and infant movement.
Warning! Do not attempt to plug the Natus ATA3i or Preamp3i cable into any other equipment, as
unspecified damage to either component may occur. Both the ATA and the Preamp/PCA cables are
patient connected cables and must only be plugged into the ALGO 3i device.
Warning!Print or export data to a PC outside of the immediate patient care area.
Warning! When the device battery requires replacement, always change batteries outside of the
immediate patient care area.
Warning! The ALGO 3i screener must be disconnected from the battery charger before screening. The
battery charger has a functional earth for electromagnetic compliance. The ALGO 3i screener will not
allow screening to be initiated or continued when the charger is connected. If a user connects the device
to the charger during a screening in progress, the device will display a warning message and will exit
the screening. This is to prevent the mains artifact from affecting the screening results.
Warning! To avoid the risk of electric shock, this equipment must only be connected to a supply Mains
with protective earth.
Warning! This equipment may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures such as reorienting or relocating the
equipment.
Warning! If the device is not to be used for an extended period of time, remove the battery pack to avoid
leakage of electrolyte.
Warning! Follow local ordinances in coordination with your hospital’s or institution’s protocol for
proper disposal of battery, ALGO 3i device, battery charger, and any accessories.

I. Intended Use
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Caution: Although the ALGO 3i fulfills the relevant EMC requirements, precautions should be taken
to avoid unnecessary exposure to electromagnetic fields, e.g., from mobile phones, etc. If the device is
used adjacent to other equipment it must be observed that no mutual disturbance appears. Please refer to
appendix A for more information regarding EMC.
Caution: Use only Natus screening supplies with ALGO screeners. Use of non-Natus supplies
may damage the ALGO screener, may affect the accuracy of screening results, and will void the
warranty.
Caution: Use only the Natus-approved battery charger (REF 900611) delivered with the ALGO 3i
screener. Battery chargers not approved by Natus may not meet electrical and safety standards. Use of
other chargers may cause damage to the device and Natus is not liable for damages caused in their use.
Caution:Incorrect use of the ALGO 3i screener and its accessories, or the use of parts and accessories
not supplied by Natus Medical Incorporated, can lead to incorrect results.
Caution: There is no user access to the software operating system. Any attempt to access the software
operating system is expressly prohibited, may affect screening results, and will void the warranty.
Caution: Any misuse or alteration of the Natus earphones or Natus ATA3i cable (including removal of
the sound insulating wool from the ATA3i cable) may result in screening at unknown and uncontrolled
decibel levels leading to erroneous screening results, and will void the warranty.
Caution: Refer to ALGO 3i Reference and Service Manual for additional troubleshooting,
maintenance, calibration, & preventative inspection information.

II. Overview of the ALGO Screening Technology
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II. Overview of the ALGO Screening Technology
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”.
Natus sensors on the baby’s skin capture the ABR and transmit it to the ALGO 3i screener.
Since these signals are very small compared to other bio-electrical activity in the baby’s brain, it is
important that the baby is sleeping or in a quiet state. The ALGO screener uses patented signal
processing technology to separate the ABR from background noise and other brain activity.
These responses are matched against a stored pattern called a “template”, derived from the ABRs
of normal-hearing infants. The ALGO screener must detect the ABR with very high statistical
confidence in order to issue a PASS result. The ALGO technology includes a patented dual-
artifact rejection system to prevent non-ABR activity from contributing toward a PASS result.
This ensures a very high degree of accuracy of the PASS result issued by an ALGO device.
The ALGO screener will issue a PASS result when it collects sufficient data to establish with
> 99% statistical confidence that an ABR signal is present and consistent with the template. This
confidence level can be reached at a minimum of 1000 sweeps for 35dBnHL screening, and 2000
sweeps for 40dBnHL screening.
The ALGO screener will continue to collect data up to 15,000 noise-weighted sweeps. If it has
not established with > 99% statistical confidence that the ABR signal is present after 15,000
noise-weighted sweeps, it will issue a REFER result.

III. Screening Device and Components
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III. Screening Device and Components
The ALGO 3i screener is a handheld, battery-operated device containing a set of customized
electronic components that incorporate the Natus AABR®technology. It also contains an
infrared (IR) port which can be used to transfer or print screening results, and a connector to
plug in the battery charger.
Device Components
A. Power-On slider switch
B. Display
C. Navigation buttons (keys)
D. Earphone (ATA) cable connection
E. Sensor (Preamp/PCA) cable connection
F. Infrared (IR) port: printing/data export
G. DC power port: battery charger connection
H. SoftClip™: device stand/bassinet clip
The device uses two cables which are plugged in at the top of the device. The earphone cable has
colored transducers which contain speakers to generate the clicks, microphones to listen for
ambient noise, and a memory chip which stores cable calibration information. The preamp or
sensor cable contains colored clips which attach to the Natus sensors, and a preamplifier to
transmit responses back to the ALGO 3i screener. The earphone and sensor cables are each
available in two different lengths, 31 inches (78.7 cm) and 90 inches (228.6 cm). The short cables
are the ATA 3i (earphone) cable and the Preamp 3i (sensor) cable. The long cables are the ATA
3 (earphone) cable and the Preamp 3/PCA 3 (sensor) cable.

III. Screening Device and Components
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Short Cables:
Preamp3i (Sensor) Cable ATA3i (Earphone) Cable
Caution: Always turn off the screener before connecting or disconnecting any component, to avoid
damaging the device.
Caution: Do not allow cables to dangle from the screener, or to hit hard surfaces. Damaged cables may
cause incorrect screening results.
Natus screening supplies have been validated for use with the Natus ALGO hearing screeners.
Natus does not support any screening results obtained with supplies from other manufacturers.
Natus Earphones Natus Sensors
Natus sensors are specialized low impedance electrodes which allow the ABR signals to be
transmitted across the infant’s skin to the ALGO 3i screener. Natus sensors are coated with a
conductive adhesive designed for use on neonates.
Natus earphones isolate the ear from background noise while avoiding introduction of probe tips
into the infant’s ear canal. Only Natus earphones have been validated to yield the appropriate
acoustic performance for use with the ALGO screening system.
Skin prepping materials, such as NuPrep®gel, remove surface oil or skin debris at the sensor sites
on the baby. These products lower the electrical impedance of the skin and can improve the
sensor connections. Your service representative can provide information and options for ALGO
screening supplies and prepping materials.