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Caution:

Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly

licensed practitioner).

customers of Natus is strictly prohibited. Reproduction of any part of this document without the expressed

written consent of Natus Medical Incorporated is strictly prohibited.

The content of this manual may change without notice.

AOAE

, Natus

, and Echo-Screen

are registered trademarks of Natus Medical Incorporated.

NuPrep

is a registered trademark of D.O. Weaver & Co.

Windows

is a registered trademark of Microsoft Corporation.

Bluetooth

s a registered trademark of the Bluetooth SIG.

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]

www.natus.com

Natus Manufacturing Limited

IDA Business Park

Gort, Co. Galway, Ireland

Tel.: +353 (0)91 647400

Website: natus.com

Natus...Where Babies Come First.™

Содержание Echo-Screen III Pro

Страница 1: ...2020 Natus Medical Incorporated 026057 RevE Revision Date 05 31 2020 Echo Screen III Pro Instructions for Use TEOAE DPOAE ABR Version 1 1...

Страница 2: ...his manual may change without notice AOAE Natus and Echo Screen are registered trademarks of Natus Medical Incorporated NuPrep is a registered trademark of D O Weaver Co Windows is a registered tradem...

Страница 3: ...Interface 5 Entering Data 5 Powering On and Off and Logging In and Off 6 Working with Patient Information 6 Preparing for Testing 9 Prepare the Device 9 Check the Environment 10 Assess the Patient for...

Страница 4: ...ining the Device and Components 30 Storing the Device and Components 30 Cleaning the Device and Components 31 Replacing the OAE Probe Nozzle 33 Maintaining the Battery 34 Inspecting Parts 36 Accessori...

Страница 5: ...a hearing loss may be present The Echo Screen III product family consists of handheld automated OAE and ABR based hearing screening systems which are easy to use The measurement flow is menu guided a...

Страница 6: ...sors electrodes ear tips inserts and their packaging materials as well as parts of the screening system that may come into contact with the bassinet contain small parts that may present a choking haza...

Страница 7: ...ntegrity of the Echo Screen III Pro each time an update upgrade or additional change is made within a networked environment Use only Natus screening supplies and accessories with the Echo Screen III P...

Страница 8: ...Electrical and Electronic Equipment Directive Symbol Product should not be disposed of in normal waste Manufacturer Direct current AC DC adapter USB port Electrostatic sensitive device Authorized rep...

Страница 9: ...screening Probe requires disposable ear tip and fits into patient s ear ATA cable Optional for ABR screening Cannot be used for OAE screening Attaches to disposable earphones that fit over baby s ear...

Страница 10: ...eader to display the touch screen keyboard To move to the next field touch the Enter key on either keyboard or press an arrow key on the physical keyboard To enter letters with diacritical marks press...

Страница 11: ...nd splash screens The device starts in about a minute Log in if configured by your administrator You may need to enter a combination of user name password or location to log in When powered on press t...

Страница 12: ...d upload it to the device Uploaded patients are added to the To Do List See the audble Desktop User Guide for details Note When you upload patients with risk factors you do not see the risk factors on...

Страница 13: ...ients select the patient to be edited 3 Touch Edit 4 Change patient information as needed 5 Touch Save to screen later or touch Screen to start screening immediately Enter risk factors if configured o...

Страница 14: ...en or connect to a patient while it is docked in the docking station or plugged into external power Do not turn off medical equipment suspected of causing interference unless under the direct supervis...

Страница 15: ...and touch To Do to add the patient to the To Do List In the To Do List select the patient Touch Add Patient to add a new patient to the device Check the Environment During screening it is important t...

Страница 16: ...the test OAE cable for TEOAE or DPOAE tests ATA or OAE cable plus PCA cable for ABR tests 2 For ATA or OAE cables align the double ridges on the connector blue on both cables with the slots in the ATA...

Страница 17: ...side Attach the clips to the electrodes before removing the electrodes from the adhesive liner card 3 Hold the electrodes by the tabs One at a time remove the liner card from each electrode and attac...

Страница 18: ...s are designed for single patient use Do not reuse Note Flexicoupler earphones are designed only for use with newborn patients Note Flexicoupler earphones are intended only for use with the ATA cable...

Страница 19: ...preparing for an otoscopy Compensate for spontaneous head movements by reducing the strain on the probe cable either form a big loop that is loosely held with one hand close to the head of the patient...

Страница 20: ...ening programs TEOAE DPOAE and DPOAE screenings use only the OAE probe cable IMPORTANT Before you begin check the calibration date displayed on the Home screen You cannot perform a screening when the...

Страница 21: ...reen Note Touch Cancel or press the Back key on the keyboard to close the Add Comment screen without saving your changes 4 Optionally if configured by your administrator touch Exam to specify the scre...

Страница 22: ...u rescreen the patient 9 Touch Screen Opposite Ear Insert the probe in the other ear and touch Continue to repeat the process 10 Clean the OAE probe and cable after each use Performing an ABR Screenin...

Страница 23: ...e the risk factors that were set for the patient in the audble software However any risk factors you specify for the patient on the device will be merged with the patient s risk factors in the audble...

Страница 24: ...cally Monitor the screening progress Note You can temporarily pause or stop the test at any time If you pause testing elapsed time stops updating until you resume the test 9 When the test completes th...

Страница 25: ...the USB and power cables 2 Wipe down the cable with a prepackaged alcohol wipe or with a lint free cloth dampened not wet with 70 isopropyl alcohol 3 Wipe the transducers For OAE cables wipe the prob...

Страница 26: ...ng Labels Before you can print labels for the first time your administrator needs to configure the device for Bluetooth and you must pair the device with the printer After pairing the device finds the...

Страница 27: ...ted for a PIN type 0000 IMPORTANT Try to enter the PIN within about 15 seconds If you receive a pairing error when the PIN prompt is displayed touch Cancel at the Connecting please wait prompt and the...

Страница 28: ...s for a regular test 2 On the Home screen touch Quick Test 3 Touch the type of test you want to perform Only the modalities that have been purchased by your organization are available DPOAE is availab...

Страница 29: ...f the device IMPORTANT Wait about 10 seconds after connecting the cable before starting the cable test to allow the device time to recognize the cable 2 Fit a tree tip onto the probe nozzle and then f...

Страница 30: ...amber Clean or replace the probe nozzle Contact Technical Service or your authorized service representative ATA Cable The ATA cable check requires both the ATA cable and the PCA cable to be plugged in...

Страница 31: ...hone hooks into the indents at the bottom of the docking station 3 On the Home screen touch Equipment Check Your Equipment Check screen might look different depending on the modalities activated on yo...

Страница 32: ...A cable 1 Plug the PCA cable into the PCA right port at the bottom of the device 2 Squeeze each PCA clip open and press into the test fixture with the matching color 3 On the Home screen touch Equipme...

Страница 33: ...il contact Natus Technical Service or your authorized service representative Hardware Test the hardware 1 Disconnect all cables from the device 2 On the Home screen touch Equipment Check 3 On the Equi...

Страница 34: ...Systems Test screen touch LCD Test The test begins immediately with a test pattern 4 Watch for any distortion or other problems during the test and then touch Done 5 If you saw any distortion or other...

Страница 35: ...t the keyboard 1 On the Home screen touch Equipment Check 2 On the Equipment Check screen touch Systems Test 3 On the Systems Test screen touch Keyboard Test 4 Press the key on the device keyboard tha...

Страница 36: ...oved cleaners are isopropyl alcohol and mild soapy water solution WARNING No modification of this device is allowed CAUTION If the Echo Screen III screener and docking station will not be used for a l...

Страница 37: ...ttery Use a damp not wet lint free cloth moistened with mild detergent such as liquid dishwashing detergent and water diluted to the detergent manufacturer s recommendation to wipe the device s plasti...

Страница 38: ...ing detergent and water diluted to the detergent manufacturer s recommendation to remove built up dirt and grease from the cable jacket 3 Wipe the transducers For OAE cables wipe the probe housing and...

Страница 39: ...esigned to retain a charge for least 40 screenings before needing to be recharged A screening is defined for this purpose as a complete bilateral ABR test from start to finish from entering patient in...

Страница 40: ...pose the battery to fire or to temperatures greater than 60 C 140 F for example in a parked car in direct sunlight Doing so can melt the insulating materials and or damage the safety mechanism Do not...

Страница 41: ...2 Insert the spare battery and snap it into place 3 Power up the device Hot swap batteries 1 Plug the power cord into the Echo Screen III device 2 Remove the old battery and insert the spare battery a...

Страница 42: ...Inspect the Echo Screen III device for external damage Accessories and Supplies Use only the supplies accessories and replacement parts that are approved by Natus for the Echo Screen III Pro device Ot...

Страница 43: ...qty 20 203209 OAE Preemie Tree Tip qty 100 203219 ABR Supplies ALGO PAK earphones and electrodes 36 sets box 040546 VALU PAK earphones and electrodes 288 sets box 040670 Jelly Tab electrodes 40 tripl...

Страница 44: ...Pro Instructions for Use Modality upgrades Data management software device management tools and user documentation Item Name Description DPOAE upgrade 013558 TEOAE upgrade 013559 ABR upgrade includes...

Страница 45: ...mm 28 in diameter conductive stylus Keypad Physical QWERTY style 37 key alphanumeric elastomeric keypad Virtual On screen QWERTY keyboard Sound Speaker Internal user configurable for key clicks and us...

Страница 46: ...rp Stimulus level 30 35 40 45 dBnHL Stimulus calibration Self calibrated to ear canal OAE probe Click chirp rate 52 Hz Notch filter 50 or 60 Hz user selectable Amplifier gain 79 dB Amplifier CMRR 105...

Страница 47: ...spare battery charger Battery charge time 4 5 hours to 100 AC adapter 100 240 VAC 50 60 Hz 0 6A OUTPUT 5V 3 0 A Equipment check Integrated ABR patient cable test fixture Docking interface connector Mi...

Страница 48: ...specified or provided by Natus Medical Incorporated could result in increased electromagnetic EMISSIONS or decreased electromagnetic IMMUNITY of the equipment and result in improper operation WARNING...

Страница 49: ...Standard Immunity Test Levels Professional Healthcare Facility Environment Electrical Fast Transients Bursts IEC 61000 4 4 2 kV 100 kHz repetition frequency Surges Line to line Differential Mode IEC 6...

Страница 50: ...ode IEC 61000 4 5 2 kV Conducted Disturbances Induced by RF Fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Test Frequency MHz Band MHz Service Mod...

Страница 51: ...2 it is essential to use only the following accessories NOTICE Conformance to the EMC requirements specified in IEC 60601 1 2 is ensured if the cable types and cable lengths are as specified above 5...

Страница 52: ...026057 RevE 48 2020 Natus Medical Incorporated Appendix A Electromagnetic Compatibility EMC Echo Screen III Pro Instructions for Use...

Страница 53: ......

Страница 54: ...Echo Screen III Pro Instructions for Use 026057 RevE...

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