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ALGO

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

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.

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

Содержание ALGO 3i

Страница 1: ...ALGO 3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08 05 2020 1 Instructions for Use...

Страница 2: ...ribution 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 Nat...

Страница 3: ...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 C...

Страница 4: ...ic 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 u...

Страница 5: ...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 wi...

Страница 6: ...d 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 d...

Страница 7: ...y 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 s...

Страница 8: ...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 screene...

Страница 9: ...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 cab...

Страница 10: ...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 con...

Страница 11: ...ons 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 gree...

Страница 12: ...ns 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 t...

Страница 13: ...t 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 C...

Страница 14: ...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 t...

Страница 15: ...es 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...

Страница 16: ...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...

Страница 17: ...ive 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...

Страница 18: ...w 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...

Страница 19: ...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...

Страница 20: ...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...

Страница 21: ...ccur normally in infants within the first day of life The outer ear canal is sticky and may experience temporary collapse during this period These conditions may obstruct the ear canal and cause longe...

Страница 22: ...ning if the 40 dBnHL option is enabled Select the desired parameter by scrolling through the available choices and Click OK to proceed 35 dBnHL screening only default setting 40 dBnHL screening option...

Страница 23: ...the baby may cause non physiologic noise and prolong screening times Caution Do not lay patient cables across the device during screening This may cause non physiologic noise and prolong screening tim...

Страница 24: ...eening time This displays the total screening time not including pauses iii Sweep Counts This displays the sweep counts for both ears The sweep counts are not displayed once the screen is complete The...

Страница 25: ...Screening Paused window Note The X key with the pause icon allows you to pause screening from the Screening in Progress or Infant Data Window SpeedScreen only Pause and Cancel Screening During the scr...

Страница 26: ...be saved if at least one ear has achieved a result The ALGO 3i battery must be charged before another hearing screening can be performed Step 8 Observe screening complete Monitor screening until comp...

Страница 27: ...rds Note In non screening modes if the ALGO 3i screener has not been active for a period of 10 minutes i e no buttons have been pushed it will turn itself off This is to preserve battery power However...

Страница 28: ...sh to enter infant data for the screening record click OK from the Screening in Progress window to access the Infant Data window i You must access the Infant Data window prior to completion of the scr...

Страница 29: ...the Message Box of the Infant Data Window notifying you that the test has finished The ALGO 3i screener will wait indefinitely for you to complete and confirm the infant data before matching it to th...

Страница 30: ...Management window Action If Printing If Exporting Scroll and click OK Print Selected Records Export Selected Records Confirm Intention by clicking OK Turn on the printer confirm that sufficient labels...

Страница 31: ...te After the ALGO 3i screener has sent the record to the printer it will display the Printing Complete message and ask you to click OK The ALGO 3i screener will confirm the number of records exported...

Страница 32: ...ned as close to hospital discharge as possible Do not prep compromised or irritated skin Prepping Tips Prep the skin by creating some friction but never using force Prepping is a learned technique Be...

Страница 33: ...ensor s and check impedance If readings range from 12 20 kOhms gently hold the sensors to the skin for a minute to allow them to adhere then wait a few minutes Impedances may decrease If readings rema...

Страница 34: ...eener you will first need to select them Data Export to a Personal Computer PC Printing a Label on the desktop label printer Note Once you have selected records and while you remain in the DataManagem...

Страница 35: ...ing record corresponding to the review which is highlighted This enables users to accurately select the screening records desired by viewing information stored for that screening record 4 Use the togg...

Страница 36: ...rds An ALGO 3i Printer Option is required in order to print screening records Please refer to Natus Technical Notice ALGO 3i Printing Option doc located on the CD delivered with your ALGO 3i screener...

Страница 37: ...eans that the ALGO 3i screener will send data to the printer even if the printer is not turned on or not printing Be sure to monitor printing to ensure that all records print To print SELECTED screeni...

Страница 38: ...f a screening record Whenever 100 records are stored in the ALGO 3i screener the ALGO 3i screener will ask permission to delete the oldest record stored in the device prior to initiating screening If...

Страница 39: ...The ALGO 3i screener will warn you if any of the records you have selected have not previously been exported to a PC Click X to return to DataManagement WITHOUT deleting records Click OK to continue d...

Страница 40: ...e performed to verify that the ALGO 3i system is operating correctly Performing these checks requires the Natus ALGO Check Kit REF 040527 delivered with the ALGO 3i screener and shown below B Impedanc...

Страница 41: ...The display should read Check VERTEX Sensor Vertex Impedance 99 kOhms Nape Impedance 0 kOhms 5 Detach only the Common green clip The display should read Check EACH Sensor Vertex Impedance 99 kOhms Na...

Страница 42: ...lternates between PASS and FAIL the source of interference is not clear Move the ALGO 3i screener to another location and repeat the test If the FAIL or PASS FAIL condition persists call Natus Technic...

Страница 43: ...d Incorrect VIII Data Protection Passwords Errors during screening process Cable Disconnected V Pause and Cancel Screening Battery charger connected V Pause and Cancel Screening Screening time limit e...

Страница 44: ...r Part number Reorder number Serial number Expiration date Use by date Do not reuse single patient use only Label Printer Paper feed Attention consult accompanying documentation AC Power DC Power Batt...

Страница 45: ...tions per IEC 60601 1 Ed 3 1 Class II equipment when used with the charger Internally powered when used standalone BF type applied parts Ordinary equipment for protecting against ingress of water IPX0...

Страница 46: ...RNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of this instrument including cab...

Страница 47: ...tic Fields IEC 61000 4 8 30 A m 50 Hz or 60 Hz Table 5 Immunity Test Levels Input A C Power Port Phenomenon Basic EMC Standard Immunity Test Levels Professional Healthcare Facility Environment Electri...

Страница 48: ...in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Table 8 Immunity Test Levels Signal Input Output Parts Port Phenomenon Basic EMC Standard Immunity Test Levels Professional Healthcare Facility...

Страница 49: ...50 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 P...

Страница 50: ...6 Natus Medical 812 mm EEG Preamplifier Cable long 030697 Natus Medical 1 727 mm EEG Leads used with long EEG cable only 040740 Natus Medical 648 mm ATA Acoustic Transducer Cable long 010724 Natus Med...

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