ALGO 3i Instructions for Use Rev D May 2020

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: +1-800-303-0306 Telephone: +1-650-802-0400 Fax: +1-650-802-8680 E-mail: [email protected] Global Sales & Support: 1-800-303-0306 Fax: 1-650-802-0401 www.natus.com Technical Contact Information: In the United States, contact Natus Technical Service at +1-888-496-2887 or +1-650-802-0400. Outside the United States, please contact your authorized service representative.

Natus Manufacturing Limited IDA Business Park Gort Co. Galway, Ireland Tel.: +353 (0)91 647400 Website: natus.com

© 2020 Natus Medical Incorporated

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Contents

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

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Contents

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

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I.

I.

Intended Use

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 infants exhibiting cranio-facial head abnormalities, including structural abnormality of the outer, middle, or inner ear infants with known or suspected neurological conditions infants in an agitated state

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. 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. 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.

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I. Intended Use 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.

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I.

Intended Use

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.

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II. Overview of the ALGO Screening Technology

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 dualartifact 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.

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III. Screening Device and Components

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.

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III. Screening Device and Components 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.

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IV. User Interface Navigation

IV.

User Interface Navigation This section provides basic instructions on navigating through the ALGO 3i screener’s software interface and on entering infant data in the device. Detailed instructions on performing a screen follow in Chapter V. ALGO 3i Screening Procedure.

Description of Keys The ALGO 3i screener has an intuitive, icon-based user interface which is easy to navigate. The device has six navigation buttons: Up/Down Arrow Keys

Toggle Key OK Key X Key

? Key

Up/Down arrow keys: These keys control the movement within the user interface, enabling the user to move between and select from the available options presented in the display. Toggle key: This large key enables up/down/left/right movements, and is primarily used to scroll through the alphanumeric keypad to input data and passwords. OK key: This green key controls the “YES”, “OK”, and “CONFIRM” functions, which allow a command to be executed. X key: This red key controls the “NO”, “STOP”, and “PAUSE” functions, which allow a command to be stopped, screening to be paused, or allows the user to return directly to the MainMenu. ? key: This key controls the Help system and will access the section of the ALGO 3i screener’s help system corresponding to the area of the interface where the user is located. The user can scroll through the Help system to access different information as desired. The display will always indicate to the user which keys are used to select, scroll, advance to the next window, or go back to the previous window. Examples:

Go Back (to MainMenu)

Advance (to DataManagement)

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IV. User Interface Navigation

Scrolling/Selecting in the ALGO 3i Screener The ALGO 3i screener will show you which keys are “active” or “inactive” at all times. “Inactive” keys or functions will turn light blue to indicate they are not available to the user. Wherever the ALGO 3i screener presents you with options, these will be framed by blue bars showing an up and down arrow key. This indicates you may scroll through the options by pressing either arrow key. Press the arrow key once to scroll to the next option. Press and hold the arrow key to scroll rapidly through the available options. Scroll until the black select bar highlights the desired option. The select bar will indicate what to do to activate your option (in most cases, clicking on the OK key) and the Message Box, located on the bottom of the window, will update to provide further information about your choice.

Example of a Message Box Most options within the ALGO 3i screener are single choice options, meaning the user may only select one of the available options at a time. Examples are: 

time and date format options (User Preferences)



language options (Biomed Preferences)



printer options (DeviceSetup)

Single-choice options are indicated by a

. See following illustration.

You will always use the up/down arrow keys to scroll the options, and OK to select one.

A few options within the ALGO 3i screener are multi-choice options, meaning the user may select more than one at a time. Examples are:

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IV. User Interface Navigation 

Required Fields (Biomed Preferences)



Select Records (DataManagement)

Multi-choice options are indicated by a toggle key symbol

. See following illustration.

In this case, the black select bar indicates use of the toggle keys to select or deselect the desired option set. Use the OK button to save your option set.

Data entry in the ALGO 3i Device You may enter data in the following areas of the user interface: DeviceSetup Function 

Enter password to access User Preferences



Enter password to access Biomed Preferences



Change User and Biomed passwords



Set PasswordProtection password

SpeedScreen™ or ScreenBaby Mode 

Enter infant identifier (alpha-numeric, up to 12 characters)



Enter infant’s last name (alpha-numeric, up to 24 characters)



Enter infant’s first name (alpha-numeric, up to 12 characters)



Enter infant’s date of birth



Enter user identifier (alpha-numeric, up to 12 characters)



Enter Comment info (alpha-numeric, up to 24 characters)

Data is entered into the ALGO 3i screener by using the up/down toggle keys to scroll through a keypad containing the numbers 0–9, the Roman character alphabet A–Z, a blank space,’+’, ’-‘, ’/’, ‘,’(comma), ‘.’(period) and ‘?’ . You may scroll forwards and backwards through the keypad by clicking the up arrow key (A, B, C, D….) or the down arrow key (9, 8, 7, 6…). Note: The Roman character alphabets A-Z consist of language specific characters. For example, the character ‘Ñ’ is only found if the device is set to Spanish. Note: Only if the alpha-numeric function is enabled) will the capitalized Roman character alphabet sequence appear with the number sequence in the Infant Identifier and User Identifier fields. (See Chapter VIII. Service Manual: Device Set-Up: User Preferences)

Blank Spaces

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IV. User Interface Navigation There is a blank space in the keypad between A and 9 (or between 9 and 0 if alphanumeric entry is disabled). This allows users to insert blank spaces if needed in the data fields or to remove characters. Note: The infant identifier data field may not begin with a blank space.

Example of Entering Data The black select bar will indicate which data field is active, and a cursor symbol will indicate the current position within the data field. To begin scrolling through the keypad, click on the up or down toggle keys (press and hold key for rapid scrolling). When you have located the correct number or letter, simply click on the right or left toggle keys to set it and move one space right or left. To advance to a different data field, click one of the arrow keys. Example:

Enter infant identifier 6C, then move to the Last Name field

1.

Enter the Infant Data window. The cursor will be set on the first space of the 12-digit infant identifier data field.

2.

Click the down toggle key to scroll through the numbers 9…8…7…6.

3.

Click on the right toggle key to set the first space to the number 6 and advance to the second space.

4.

Click the up toggle key to scroll through the letters A…B…C.

Page 1 of Infant Data Window

5.

Click the down arrow key to set the second space to the letter C and move to the Last Name data field.

Use the same process to enter data into the other fields of the Infant Data window. Page two of the Infant Data Window allows the user to enter the Date of Birth, User ID and Comments.

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IV. User Interface Navigation

Page 2 of Infant Data Window Note: The Infant Data window consists of two pages. The first page allows entry of the Infant ID, Last and First Names. The second page allows the entry of the Date of Birth, User ID and Comment fields. You may re-enter any data field within the Infant Data window as long as you remain within these two pages. Once you have exited the Infant Data window, you may not re-enter this area. The ALGO 3i screener will prompt you to confirm your intent to exit the area. Be careful to enter all infant data accurately!

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V. ALGO 3i Screening Procedure

V.

ALGO 3i Screening Procedure This section will first provide a 12-step basic overview of the screening procedure. Then each step will be described in further detail. See Chapter IX. Troubleshooting for information on problem resolution for any of these steps. Note: Prior to initiating the first screening procedure, ensure that the User and Biomed preferences have been set per your program requirements. Refer to Chapter VIII. Service Manual: Device Set-Up.

Overview of Screening Procedure Step 1. Power on: Turn on the ALGO 3i screener by sliding the On/Off switch upward, and releasing it. Start-up/Warnings: The ALGO 3i screener will briefly display a Start-Up window while it performs a self-check. Warnings may appear which may require your acknowledgement. The MainMenu will appear next. Step 2. Observe MainMenu: The MainMenu shows each of the major functions of the ALGO 3i screener, and is indicated by this icon: a.

SpeedScreen, if enabled (SpeedScreen mode)

b.

Enter Data/ScreenBaby (ScreenBaby mode)

c.

DataManagement

d.

Device Set-Up

SpeedScreen disabled (default setting)

SpeedScreen enabled

Step 3. Select screening mode a. SpeedScreen allows you to immediately begin screening, with the option of entering infant data during the screening process. b. Enter Data/ScreenBaby allows you to create an infant record and select screening configurations prior to initiating the screening process. Step 4. Prepare baby and attach supplies: Prepare the infant for screening by ensuring that no exclusion criteria are present, and that the infant is in a quiet state. Evaluate skin and prep if necessary. Connect cables to Natus screening supplies (earphones and sensors).

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V. ALGO 3i Screening Procedure Attach screening supplies on infant: sensors on nape, vertex, and common sites and earphones around ears. Step 5. Select screening parameters: Select either the 35 dBnHL or the 40 dBnHL screening (if 40 dB option is enabled). Select Simultaneous (not available for 40 dB), Sequential, Right-only, or Left-only screening. Step 6. Start Screening/Check Impedances: Test immedicately begins after screening parameters are selected. Monitor the impedances at each sensor location. Step 7. Monitor screening in progress: Monitor impedances and the Message window during the screening. The ALGO 3i screener will alert you to any conditions which require your attention during the screening process. Step 8. Observe screening complete: At the completion of the screen, the ALGO 3i screener will save a screening record to memory, and will display the infant data, including a summary of the screening results. Step 9. Remove/discard supplies: Remove from the baby and discard the Natus screening supplies. Step 10. Return to MainMenu/Disposition screening record: Return to the MainMenu or go to DataManagement for printing, exporting, or deleting the screening record. Step 11. Power off: Turn off the device by sliding and holding the ON/OFF switch for 3 seconds. Step 12. Clean Sensor and Earphone cables before and/or after use: Clean patient cables after use. Residual sensor adhesive may corrode Preamp3i cable clips.

Detailed Instructions of Screening Procedure Step 1: Power-On and Start-Up/Warnings Power on the ALGO 3i screener by sliding the On/Off switch upward, and releasing it. The switch will spring back to its original position. During the start-up, the ALGO 3i screener will run through a series of self-checks, and will alert you of any important messages such as: 

Battery shutdown warning: The ALGO 3i screener will automatically shut itself down to protect the device settings and saved screening records if the battery charge is too low. Recharge of the battery must occur before the MainMenu can be accessed.



Battery low warning: The ALGO 3i screener will warn you if the battery is too low to perform a complete hearing screening. You will be able to access all device functions except the screening modes. Recharge of the battery must occur before hearing screening can be performed.



Cable disconnect warning: If the preamp or ATA cable is not connected, the ALGO 3i screener will warn you that a hearing screening cannot be performed. You must connect both cables prior to screening.



Faulty ATA warning: If the calibration data cannot be read from the ATA, the ALGO 3i screener will warn you that a hearing screening cannot be performed. You must replace the ATA prior to screening.



Calibration warning: The ALGO 3i screener will issue multiple warnings as the calibration due date of the ATA nears. If the calibration is out of date, the ALGO 3i screener will warn you that a hearing screening cannot be performed. You must connect a calibrated ATA prior to screening. (See Chapter VIII. Service Manual: ATA Calibration information)

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V. ALGO 3i Screening Procedure 

System error: The ALGO 3i screener may provide information on any system errors which have occurred, and will only proceed to the MainMenu if the system is verified. If the current time and date has been lost, the ALGO 3i screener will prompt you to reset these values prior to proceeding.



PasswordProtection feature: If a password is required to gain access to the MainMenu, this feature is enabled. Enter the correct password to proceed.

Warning! You must turn off the device prior to disconnecting and reconnecting cables.

Step 2: Observe MainMenu Observe that two screening modes may be displayed in the MainMenu window: •

SpeedScreen mode for advanced users (see next section after Steps 12)

•

Enter Data and Screen Baby mode (ScreenBaby mode).

Step 3: Select screening mode ScreenBaby mode is the standard and default screening mode used when infant information is required for the infant record, and for new users. ScreenBaby mode allows users to create an infant record and to select screening configurations prior to starting the screening process. A. Select Enter Data/ScreenBaby and click “OK” B. The ALGO 3i screener will advance to the Infant Data window.

Infant Data Window C. In the Infant Data window, enter infant information for the screening record. There are three data fields in the first Infant Data window: Infant Identifier, Last Name and First Name. There are another three data fields in the second window: Date of Birth, User Identifier, and Comment. The default for each field is a blank space, and all data fields contain 12 data spaces, except for Last Name and Comment which can contain 24 data spaces. Required fields will be indicated in pink type. You must enter data in required fields before proceeding. The Last and First Name and Comment fields are always alpha-numeric. The User and Infant Identifiers may be numeric only, or alpha-numeric. The alpha-numeric option may be selected from the User Preferences window. The Date of Birth contains separate day, month, and year fields, which will appear in the order selected in the User Preferences window (Date and Time Format). Example: Enter infant’s birth date as 28 February 2005. i.

Enter the Infant ID field and scroll down to “Date of Birth”.

ii.

The cursor will be positioned on the first field, the day.

iii. Toggle down through the numbers 31…30…29….28. iv. Toggle right to set the day to 28 and move to the second field, the month. v.

Toggle up through the months JAN…FEB.

vi. Toggle right to set the month to February and move to the third field, the year. vii. Toggle either up or down to select the correct year. viii. Scroll to the next Infant Data field, or click OK to exit the Infant Data area.

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V. ALGO 3i Screening Procedure

Note: Because the ALGO 3i screener may only be used for infants up to 6 months of age, the year options in the Date of Birth window will only be current and prior year, as well as a blank field. Note: If you enter an incorrect date (i.e. September 31), or if the current date precedes the date of birth, the ALGO 3i screener will require you to edit the Date of Birth field before proceeding. Note: The ALGO 3i screener will allow a date of February 29 to be entered only during leap years.

D. Click “OK” when you have verified that all information is accurate. The Message box will indicate if you have not entered data in required fields. E. The ALGO 3i screener will display all the information you have entered, and ask for confirmation. You may click “X” to return to the Infant Data Window to edit any data field. Note: Once you confirm the data in the Infant Data Window by clicking “OK”, you cannot modify it! Be sure that all information is complete and accurate before clicking OK!

F.

The ALGO 3i screener will advance to the Screening Parameters window.

Step 4: Prepare baby and attach supplies A. Attach single use Natus sensors and earphones on infant. Cables should be connected to sensors and earphones prior to attachment to the infant. To ensure quick and accurate screening results, it is important to select a baby appropriate for screening, and to correctly place the Natus screening supplies.

i.



Evaluate baby’s medical chart to ensure no exclusion criteria for Natus ALGO screening are present. (See Chapter I. Intended Use: Exclusion Criteria)



Ensure that baby is in a quiet or sleeping state, preferably after a feeding or bath.



Evaluate baby’s skin type, particularly at the vertex site, to determine whether prepping is necessary. (See in this section: Skin Prepping Techniques)

Attach preamp cable to Natus sensors by attaching the colored cable clips centered onto the colored tab section of the sensor.

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V. ALGO 3i Screening Procedure

Caution: Do not allow the clip to contact the adhesive on the sensor, as myogenic interference and eventual corrosion of the clip may occur. Do not touch the underside of the sensor, as the entire surface is conductive.

The sensor clips on the preamp cable are color coded for placement on the appropriate location on the infant. BLACK clip for sensor attachment to Vertex site (center high forehead) WHITE clip for sensor attachment to Nape site (centered, back of neck) GREEN clip for sensor attachment to Common site (shoulder) ii.

Place the nape and common sensors onto the infant, ensuring that the cables lay in the same direction. 

Gently tilt baby’s head forward to expose the back of the neck. The nape sensor (white clip) should be centered on the back of the neck, not on the skull or back.



The common sensor (green clip) should be placed on the back or front of either shoulder, not on the chest or back, and not on the hand.

Using Natus’ required sensor montage will help achieve faster test times and less myogenic interference. iii. Gently hold each sensor in place for a few seconds to allow them to warm and create good adhesion to the baby’s skin. iv.

Attach the ATA cable to Natus earphones by inserting the acoustic transducer into the round opening, and clicking it into place along the side of the earphone.

v.

Place earphones on baby by rolling the earphone from behind the ear forward. 

20

RED transducer is for the baby’s Right ear;

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