natus Algo 7i User manual

User Manual

Page 2 / 40

Page 3 / 40
Distributed By:
Natus Medical Incorporated
3150 Pleasant View Road,
Middleton, WI 53562 USA
Toll-free: [phone]
Telephone: [phone]
Fax: [phone]
E-mail: [e-mail]
www.natus.com
Technical Contact Information: In the United States, contact Natus Technical Service at +1-888-496-
2887 or [phone]. Outside the United States, please contact your authorized service
representative.
Manual Information
Article number: 101124-EN (Natus PN A7i-101124-EN)
Release date: 2020-09
Revision: 1801_MA_ALGO 7i_Manual_EN_02
Valid from: Firmware Rev. 1.0 (initial release)
This Manual is applicable to the following Part Numbers: A7i-101049
All mentioned items, products, brands and trademarks are registered or owned by the mentioned
companies. AABR, ALGO, Flexicoupler, Jelly Tab, and Natus are registered trademarks of Natus Medical
Incorporated.
PATH MEDICAL GmbH
Landsberger Straße 65
82110 Germering
Germany
Email [email protected]
Telephone [phone]
Fax [phone]
All information, illustrations, and specifications provided within this manual are based on the latest product information available at the
time of publication. PATH MEDICAL reserves the right to make changes at any time without notice.
Errors and omissions excepted.
Copyright Notice
No part of this manual may be reproduced, translated, stored, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or
otherwise, without the prior written consent of PATH MEDICAL GmbH.
Copyright © 2020 PATH MEDICAL GmbH

Page 4 / 40
Table of Contents
1 Overview...................................................................................................................................... 7
1.1 Introduction............................................................................................................................. 7
1.2 Intended Use ........................................................................................................................... 7
1.2.1 Intended Purpose............................................................................................................ 7
1.2.2 Contraindications ............................................................................................................ 8
1.2.3 Exclusion Criteria............................................................................................................. 8
1.2.4 Side Effects ...................................................................................................................... 8
1.3 Performance Characteristics ................................................................................................... 8
2 Explanation of Symbols ............................................................................................................. 10
3 Basic Operation ......................................................................................................................... 11
3.1 Screen Layout........................................................................................................................ 11
3.2 Online Help............................................................................................................................ 12
3.3 Test Result Status Icons......................................................................................................... 12
3.4 Device Hardware ................................................................................................................... 12
3.4.1 On/Off Switch................................................................................................................ 12
3.4.2 Device Reset .................................................................................................................. 13
3.4.3 Device Cable Connectors............................................................................................... 13
3.4.4 Charging the Device....................................................................................................... 14
3.5 Device Functions ................................................................................................................... 14
3.5.1 User Management......................................................................................................... 14
3.5.2 Patient Management..................................................................................................... 15
3.5.3 Device Settings .............................................................................................................. 18
3.5.4 Hardware Tests.............................................................................................................. 19
3.5.5 System Information....................................................................................................... 20
3.5.6 Test Module Information .............................................................................................. 20
3.5.7 Performing Measurements ........................................................................................... 20
3.5.8 Troubleshooting ............................................................................................................ 23
3.6 ALGOLink PC Software........................................................................................................... 24
4 Service and Maintenance.......................................................................................................... 25
4.1 General Service Information ................................................................................................. 25
4.2 Routine Maintenance and Calibration .................................................................................. 25

Page 5 / 40
4.3 Repair .................................................................................................................................... 26
5 Cleaning..................................................................................................................................... 27
6 Accessories................................................................................................................................ 28
7 Warranty.................................................................................................................................... 29
8 Notes on Safety ......................................................................................................................... 31
8.1 General Usage ....................................................................................................................... 31
8.2 Handling, Transport, and Storage.......................................................................................... 31
8.3 Electrical Safety ..................................................................................................................... 32
8.4 Electromagnetic Compatibility.............................................................................................. 33
8.5 Accessories............................................................................................................................ 33
8.6 Waste Disposal...................................................................................................................... 34
9 Technical Specifications............................................................................................................. 35
9.1 General Device Information .................................................................................................. 35
9.2 Device Characteristics ........................................................................................................... 35
9.3 Power Supply......................................................................................................................... 35
10 Electromagnetic Compatibility Information.............................................................................. 38

Page 7 / 40
1Overview
1.1 Introduction
Thank you for purchasing the ALGO 7i. This manual is your guide for safely operating and maintaining
your device.
Please read this manual carefully before using the ALGO 7i the first time. We recommend
taking particular note of the safety (see section 8: Notes on Safety), intended use (see
section 1.2: Intended Use), cleaning (see section 5: Cleaning) and maintenance (see section 4: Service
and Maintenance) instructions.
ALGO 7i devices are reliable, easy-to-use, and mobile medical devices. All devices provide
easy navigation via touch-screen and are intended for hearing examinations (see section 1.2:
Intended Use).
1.2 Intended Use
1.2.1 Intended Purpose
The ALGO® 7i Newborn Hearing Screener is a hand-held, portable hearing screener intended to
objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6
months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet
state at the time of screening. The test methodology contains:
•stimulus delivery
•EEG processing
•ambient noise processing
•PASS/REFER determination
•screening conditions assessment
•ability to screen ears individually, simultaneously and sequentially
•screening test condition monitoring
ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and
other hearing health care professionals, nurses and audiologically trained personnel. It is not
intended to be operated by lay users.
Given the simple operating principle of the ALGO device, basic training with the device is sufficient for
performing screening of patients in good health. This is considered audiologically trained in this
context.
Please consider local regulations regarding the qualification requirements for performing hearing
screening.

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”.

Page 9 / 40
The ALGO 7i hearing screener offers the user the option to screen both ears simultaneously, both ears
sequentially or each ear individually. This single technology device uses Natus’s patented AABR®
(Automated Auditory Brainstem Response) Screening technology to determine the status of the
hearing pathway from the outer ear up to the brain stem. The device offers an automatically created
result, which can have the values “PASS” (Clear Response), “REFER” (No Clear Response) or
“INCOMPLETE”.
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.
The ALGO 7i hearing 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 7i has no essential performance as related to DIN EN / IEC 60601-1.

Page 10 / 40
2Explanation of Symbols
This section explains all symbols used within this manual and on the device label.
Symbols within this manual:
Symbol
Explanation
Important notice: please read for important information.
Warning: please read for safety-relevant information, which may cause risk of
danger to persons and/or device if not followed.
Symbols on the device label:
Symbol
Explanation
Consult instruction for use, i.e. this manual.
Serial number
Article number
Medical device
Manufacturer name and address, production date
Compliance with applied part type BF (body floating) requirements
according to DIN EN 60601-1
Device with safety class II according to DIN EN 60601-1
Direct current input
The device is electronic equipment covered by the directive 2012/19/EC on waste
electrical and electronic equipment (WEEE). When discarded, the item must be
sent to separate collection facilities for recovery and recycling.
CE mark to declare conformity with medical device directive 93/42/EEC. The
number below the CE mark refers to the identifier of the notified body.
For further symbols, e.g. on accessory labels, please refer to the respective manual or data sheet of
the accessory. Important symbols may include:
Symbol
Explanation
Single use only. Do not reuse the respective item.
Expiration date. Do not use the respective item after the specified date.

Page 11/40
3Basic Operation
After switching on the device, the device can be operated via a touch-sensitive display. In the following
section, the most important device functions and screen elements are explained.
Please note that screen shots or references to test modules in this manual may not reflect the actual
configuration of your device.
3.1 Screen Layout
The device screen is divided into three main sections (see Figure 1):
Figure 1: Device screen layout
①Header, including the following elements:
-Device time (e.g. 12:00)
-Screen-related information (e.g. Tab you are currently viewing)
-USB connection ( is shown if USB cable is connected to a PC)
charging status indicator from empty to full)- Battery status (
②Main screen, including screen-related elements (e.g. Speed Screen, Patient list, Patient Selection or Settings)
③Footer, including control elements (e.g. for switching off the device) and help
①Header
②Main screen
③Footer

Page 12/40
3.2 Online Help
Content-sensitive help screens allow intuitive handling of the device. Automatically generated
message boxes may present additional content-sensitive warnings or information.
The content-sensitive help screens are available via the question mark icon, which is displayed
in the footer. The help screens explain the currently available symbols and their functions.
3.3 Test Result Status Icons
In the test history list, test results are shown with an overall test result status icon. The icons
correspond to the following definitions:
Test result PASS
Screening passed successfully; no further testing necessary
Test result incomplete
Screening should be repeated (e.g. when baby is sleeping or in a calm state)
Test result REFER
Screening referred. Please consult your local facility protocol for next steps with
rescreening or audiological referral
3.4 Device Hardware
3.4.1 On/Off Switch
The on/off switch is located at the right side of the device housing (see Figure 2). The on/off switch can
be used to switch on or off the device. For switching on the device, press the switch briefly. The
welcome screen appears. For switching off the device, press the switch for approximately 10 seconds.
Figure 2: On/off switch

Page 13/40
Alternatively, the device can be switched off via the off-switch icon in the footer of the device
display.
3.4.2 Device Reset
If the touch screen is unresponsive (i.e., no reaction when pressing an icon), reset the device by
pressing the on/off switch for several seconds. The reset does not change any device or test module
settings or affect any other saved data on the device.
3.4.3 Device Cable Connectors
Multiple cables can be connected to the device. This includes The Acoustic Transducer Assembly (ATA),
Patient Cable, and the Multi-Data Cable (for connecting the label printer, USB communication cable,
and power cable for charging purpose). For further information, see section 6: Accessories.
The sockets can be used as described in Table 1.
Socket
Cable
ODU Grey
ATA Cable
ODU Black
Patient Cable
Hirose
Multi-Data Cable/ Docking station for Charging, USB connection and label
printer.
Table 1: Device socket overview

Page 14/40
For the Docking Station and the Multi-Data Cable, following sockets are displayed:
Label printer, modem
USB cable with type B connector
Power supply
Table 2: Device socket overview for Docking Station and Multi-Data Cable
3.4.4 Charging the Device
Connect the Multi-Data Cable to the device (see section 3.4.3: Device Cable Connectors). For charging
the device, connect the power supply to the power supply outlet and plug it to a power mains socket
with appropriate output voltage and frequency. For more information about power supply units please
see section 9: Technical Specifications and information provided on the power supply unit. When using
a Docking Station, make sure that the power supply is connected to the Docking Station and to a power
mains socket. Simply slide the device into the Docking Station. The charging process starts
automatically and completes within about 5 - 8 hours. The battery status can be derived from the
status indicator from empty to full. The
battery status icon symbol: charging
Docking Station and the Multi-Data Cable will feature a LED indicating when the device is charging.
3.5 Device Functions
3.5.1 User Management
With the ALGOLink software you can activate or de-activate the user management on your device (see
ALGOLink online help for more information). If the user management is activated, after switching on
the device, you will be asked to select a user and to enter the user password. Please follow the
explanations on the device. If you would like to change a user you need to logoff from the device and
restart the device. If the user management is active, you are only enabled to change module
parameters when logged in as administrator.
Please make sure that local data protection requirements are met. When user management
is deactivated on ALGO 7i device, the device does not provide any inherent access protection
(i.e. no login with password).

Page 15/40
3.5.2 Patient Management
After switching on the device (and if applicable after login) a patient can be added, selected from the
list of patients or the test screen can be entered directly in “Speed Screen” mode, i.e. without adding
or choosing a patient. Depending on user rights, it is also possible to delete a single patient, all patients
or patients by date range (Device Settings →Data Management).
In “Speed Screen” mode, tests can be conducted and patient data can be entered and saved
simultaneously. This may be helpful e.g. for quickly testing a sleeping child if there is no time
to enter the patient data inadvance. When conducting test in “Speed Screen” mode, always make sure
that you assign the test data to the correct patient.
Patient Data can also be added retrospectively once the test is complete by going to Patient List and
selecting the BLANK Patient that has just been screened. It is essential to enter patient data after a
Speed screen to ensure tests are assigned to the correct patient.
To add patients, tap the “New Patient” Button on the home Screen.

Page 16/40
Following information then can be entered using the keyboard on the touch display:
When done, confirm by tapping the check mark. You’ll be automatically asked if you want the patient
added to the To-Do List.
Once a Patient has been saved to the Patient and/or To-Do list, following options are available:
“Start Screen”, “Select Protocol” and “View Results”

Page 17/40
•“Start Screen”directs you to the Screening menu (see 3.5.7),
•“Select Protocol”allows you to adapt screening settings prior to your measurements (Stimulus
level and Screen method, i.e. which ear, or both ears (if enabled),
•“View Results” shows any screening result already existing to the patient.
•Tapping the icon in the middle of the footer: allows you to remove this patient from
the To-Do List (depending on potential user rights).
For further questions, please also use the device online help by tapping the question mark in the
patient screen.
When adding Patient to the To-Do- List, you can create your individual work list for each day. Either
load your To-Do- list using the ALGOLink PC Software onto your device, or choose from the patient
database on your ALGO 7i device and tap on the “add patient” button in the footer of the Patient
Details screen.
When using the To-Do- list, you can enter the patient details by tapping on the individual patient. From
there, you can operate as described above. Additionally, by tapping on the speech bubble, you can
enter or read already existing comments to this patient. Tapping the Checkbox activates the Patient-

Page 18/40
related options in the Footer (①Print Record, ②Remove Patient from To-Do List). When
Removing a Patient, please choose the reason for removal.
3.5.3 Device Settings
There are multiple options to configure the device to your needs.
The device settings can be reached via Settings Tab with the gearwheel symbol on the main screen:
The following device settings are available:
-Device Management, date and time format
-Display Options: Language, sound (key click, result sound), display
brightness, power options, keyboard preferences
-Data Management: Patient Removal, Factory Presets
-Test preferences: To-Do-List Removal Criteria
①
②

Page 19/40
For further information about device settings please see device online help on the “Settings” screen
and its submenus.
3.5.4 Hardware Tests
The main device functions can be tested with the “Functional Checks” option in “About Device”.
The device self-test examines several device properties suchas internal power supply, codec
function, and memory integrity. If a device property is correctly working, test status is
indicated as “OK”. If not all device properties are tested successfully, please contact your distributor
or Natus Sales representative. To perform the device self- test, simply touch the device self- test
button. The test will start automatically.
The Cable Test checks the ATA Cable and Patient Cable functionality. Please use the ALGO
7i Check Kit to test the Impedance levels with your cable. To do so, plug in your Patient Cable
in the black socket of your ALGO 7i device and attach all three clips to the metal bar of your Check Kit.
Then plug in your ATA Cable in the grey socket and connect to the left and right opening of the Check
Kit. Tap the “Cable Check” button and follow the on-screen instructions. Please note: Please do not
run this test without connecting cables to the ALGO 7i Check Kit. If your ATA Cable fails the Cable Check,
Screening will be disabled with this particular cable until a successful Cable Check has been passed.
If anything other than those values listed for each test step are displayed, please contact Natus
Technical Service or your Natus authorized service representative.
It might happen that one of the error messages shown in Table 3 occurs. Please follow the
recommended actions for troubleshooting mentioned in Table 3.
Error message
Recommended actions for troubleshooting
No transducer
found
Check if the ATA Cable is properly connected to the device.
→If not, connect the ATA Cable to the device.
Test Result
“FAIL”
Check if the ATA Cable is placed correctly and tightly in the test cavity.
→If not, place the ATA Cable hooks in the cavities.
Table 3: Probe test error messages and recommended actions

Page 20/40
If the recommended actions in Table 3 do not help in solving the problem, please contact Natus
Technical Service or your Natus authorized service representative.
3.5.5 System Information
On the system information screen, general information about the
device and firmware version is displayed. Information about
connected transducers is also displayed if the respective transducer has been
connected before the system information screen is entered. On the second page,
the next service date of the device and the next calibration dates of the known
transducers are listed. When contacting your distributor regarding any service
request (e.g. error message or module update) this data should be at hand.
3.5.6 Test Module Information
Auditory brainstem responses (ABR) Screening tests are performed with the device. Options include 2
Stimulus intensity levels (35dB nHL and 40dB nHL).
When conducting a measurement, please consider the following aspects:
Ambient noise levels should be minimized to avoid interference with screening. Myogenic
interference from a restless baby or environmental factors will affect the screening and
should be kept to a minimum.
For ABR measurements also make sure to test in an environment with low electromagnetic disturbance
from electronic devices (e.g. computers, lights, other electronic medical devices) as electromagnetic
radiation may deteriorate ABR test performance. Please consider local regulations regarding
requirements for the test environment.
3.5.7 Performing Measurements
3.5.7.1 Prepare the baby
Before starting a measurement, the baby needs to be prepared for screening.
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 the cables:
The ATA Cable (gray strain relief) plugs into the gray port, and the Patient Cable (black strain relief)
plugs into the black port. Align the double ridges on the bottom of each plug with the slots in the
appropriate port, and then press the cable in until it clicks into place.