natus Madsen AccuScreen User manual

Madsen®AccuScreen
OAE & ABR Screener
User Manual
Doc. No. 7-50-0920-GB/13
Part No. 7-50-09200-GB

Copyright notice
© 2010,2020Natus. All rights reserved. ® Natus, the NatusIcon, Aurical, Madsen, HI-PRO 2, Otoscan, ICS and HORTMANN are
registered trademarks of Natus in the U.S.A. and/or other countries.
Version release date
2020-09-23 (218514)
Technical support
Please contact your supplier.
MADSEN AccuScreen
2

Table of Contents
1 Introduction 7
1.1 Brief description 7
1.2 The docking station 7
1.3 The AccuLink software program 7
1.4 Printing 8
1.5 Intended Use 8
1.6 Physical operating principle 8
1.7 About this manual 9
1.8 Typographical conventions 9
1.8.1 Navigating this manual 10
2 Unpacking and Installation 11
2.1 Unpacking 11
2.2 Overview of AccuScreen 11
2.2.1 Front and rear of AccuScreen 11
2.2.2 Top and bottom of MADSEN AccuScreen 12
2.2.3 The docking station 12
2.2.4 Display 14
2.2.5 Ear probe 14
2.2.6 Electrode cable (ABR only) 15
2.2.7 Ear coupler cable 15
2.3 Storage 16
2.4 Assembly 16
2.5 Powering 16
2.5.1 The battery 16
2.5.2 Inserting the battery in AccuScreen 17
2.5.3 Battery status 17
2.5.4 Powering the docking station 18
2.5.5 Charging the battery from the docking station 19
2.5.6 Charging the battery with the external charger 19
3 Getting Started with AccuScreen 20
3.1 Switch on AccuScreen 20
3.1.1 Power-saving mode and automatic power-off 20
3.1.2 The AccuScreen screens 20
3.1.3 Selecting the user 21
3.1.4 Entering password 22
3.1.5 Incorrect password 22
3.1.6 Optional screens 22
3.1.7 The Home menu 22
3.2 Patient handling in AccuScreen 23
3.2.1 Adding a new patient 23
3.2.2 Finding a patient 26
3.2.3 Editing patient data 27
4 Preparing for testing 28
4.1 Preparing AccuScreen 28
4.2 Preparing the equipment 28
4.2.1 Preparing the probe for testing 28
MADSEN AccuScreen 3

4.2.2 Connecting the probe 28
4.2.3 Connecting the electrode cable for ABR testing 29
4.2.4 Connecting the ear coupler cable for ABR testing 30
4.3 Preparing the test environment 31
4.4 Preparing the patient 31
4.4.1 Preparing the patient for insertion of the ear probe 32
4.4.2 Fitting the eartip on the probe 32
4.4.3 Inserting the probe with eartip in the patient’s ear canal 33
4.4.4 Placing the electrodes for ABR testing 33
4.4.5 Fitting the ear couplers 34
5 Testing with AccuScreen 37
5.1 Ready to test 37
5.2 The TEOAE test 38
5.2.1 Starting the test 38
5.2.2 The TEOAE test 39
5.2.3 TEOAE test results 40
5.3 The DPOAE test 42
5.3.1 DPOAE test protocol 42
5.3.2 Starting the test 42
5.3.3 The DPOAE test 43
5.3.4 DPOAE test results 45
5.4 The ABR test 46
5.4.1 Starting the test 46
5.4.2 Impedance testing and calibration 47
5.4.3 The ABR test 49
5.4.4 ABR test results 50
5.5 Options in the test result screens 52
5.6 Adding comments to a test 53
5.6.1 Adding a standard comment 53
5.6.2 Adding a new comment 53
5.6.3 Viewing comments 54
5.7 Continuing testing on the other ear 54
5.8 Viewing a patient's test record 54
5.9 Test View 54
5.10 The Test View screen 55
6 Quick Test 56
6.1 Performing a Quick Test 56
7 Printing 57
7.1 Printing from AccuScreen 57
7.2 Printouts from label printer 59
8 Quality Tests 62
8.1 Performing Quality Tests 62
8.2 Probe test 62
8.2.1 Performing the probe test 63
8.2.2 From the Quality Tests menu 64
8.3 Electrode cable test 64
8.4 Ear coupler cable test 65
8.5 Combined (Electrode Cable - Ear Coupler Cable) 67
4 MADSEN AccuScreen

9 AccuScreen settings 70
9.1 The Settings menu 70
9.2 Time and Date setting 71
9.3 Language setting 72
9.4 Sound setting 72
9.5 Display Brightness 73
9.6 System info 73
10 Handling Data in AccuScreen 74
10.1 Entering data in AccuScreen 74
10.1.1 Using the keypad 74
10.2 Function buttons 75
10.3 General buttons 76
10.4 Deleting data 76
10.4.1 Deleting one patient 76
10.4.2 Deleting by date 77
10.4.3 Deleting all patients 78
10.5 Memory full 79
11 Maintenance and Cleaning 80
11.1 The probe tip and probe body 80
11.1.1 Cleaning and disinfecting the probe tip 80
11.1.2 Cleaning the probe body 81
11.1.3 Probe calibration 82
11.2 Eartips 82
11.3 The ear coupler cable 82
11.3.1 Cleaning the ear coupler cable 82
11.3.2 Ear coupler cable calibration 82
11.4 Cleaning AccuScreen 83
11.4.1 Cleaning and disinfecting the built-in test cavity 83
11.5 Battery safety and maintenance 84
11.5.1 Safety information 84
11.5.2 Increasing service life 84
11.5.3 Disposal of old batteries 85
App. 1 Standards and Safety 86
App. 1.1 AccuScreen symbols 86
App. 1.2 Accessory symbols 87
App. 1.3 Docking station symbols 87
App. 1.4 Warning notes - AccuScreen 87
App. 1.5 Warning notes - docking station 89
App. 1.6 Warranty 89
App. 1.7 Repair, after-sales service and regular checks 89
App. 1.7.1 Declaration 89
App. 1.8 Manufacturer 90
App. 1.8.1 Responsibility of the manufacturer 90
App. 2 Status and Error Messages 91
App. 2.1 Device related messages 91
App. 2.2 Usage and test related messages 91
App. 3 Technical Specifications 93
App. 3.1 Accessories 93
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App. 3.2 Measurement techniques 93
App. 3.3 Device 94
App. 3.4 Power supply and battery 97
App. 3.5 1077 docking station 97
App. 3.6 OAE probe 98
App. 3.7 ABR electrode cable 98
App. 3.8 ABR ear coupler cable (optional) 99
App. 3.9 Device class 99
App. 3.10 Notes on EMC (Electromagnetic Compatibility) 100
Index 105
6 MADSEN AccuScreen

1 Introduction
1.1 Brief description
Thank you for purchasing the AccuScreen handheld Otoacoustic Emissions and Automated ABR
Screener.
Note •This manual is your guide to the use and maintenance of AccuScreen. We strongly
recommend that you read it carefully before using AccuScreen for the first time.
We also recommend that you take particular note of the cleaning and maintenance instructions.
Failure to use and maintain AccuScreen correctly may void your warranty.
AccuScreen is a fast, reliable, easy to use, and lightweight hearing screener, optimised for
neonatal screening.
AccuScreen provides for easy navigation using its touch screen function.
1.2 The docking station
AccuScreen is supplied with a docking station, which provides for:
• easy recharging of the battery
• transferring data between AccuScreen and PC
• printing from a label printer
1.3 The AccuLink software program
AccuLink is a software program providing data management handling with result review and configuration capabilities in a
single PC application.
From AccuLink you can create, edit, view and print data relating to patients and tests, users, sites and connected locations
and facilities.
From AccuLink you can configure AccuScreen to suit your purposes. This includes defining mandatory fields in patient hand-
ling, defining which screens are to be shown in AccuScreen, and uploading and downloading data.
AccuScreen is operated independently of AccuLink, although additional features and configuration values are provided by
AccuLink’s user interface.
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1 Introduction

1.4 Printing
For printing instructions see Printing ►57.
AccuScreen
With AccuScreen you can upload data to AccuLink and print test results from the PC, or you can place AccuScreen in the
docking station and print directly to a label printer connected to the docking station.
1.5 Intended Use
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening
auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related dis-
orders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions:
The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including
infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioural audiometric res-
ults are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response:
The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening.
The device is intended for use by audiologists, ENTs and other healthcare professionals.
Important •Natus does not guarantee the accuracy of the test results or the tests themselves, if accessories other than
those supplied by Natus are used for this device (i.e. eartips, electrodes, ear couplers, etc.).
1.6 Physical operating principle
AccuScreen uses TEOAE (Transiently Evoked Otoacoustic Emissions) and DPOAE (Distortion Product Otoacoustic Emissions)
technologies, which are highly effective for neonatal hearing screening. Otoacoustic Emissions measure cochlear mech-
anics and indicate whether the cochlea is functioning correctly or not.Children's emissions are typically strong, which
makes them easy and fast to detect. Emission strength usually decreases with age or hearing impairment.
Automated ABR (Auditory Brainstem Response) is available in AccuScreen. This technology measures responses to sound in
the auditory pathways. It provides a valuable supplement to TEOAE and DPOAE screening, and is an essential tool for
screening infants with a risk of hearing loss.
The simple yet reliable technology ensures that hearing loss can be detected and that intervention can be implemented at
an early age. With early intervention, hearing-impaired children are given the possibility of developing normal speech and
language skills.
8 MADSEN AccuScreen
1 Introduction

1.7 About this manual
Important •Please note that menu selections and screen shots in this manual may not reflect the configuration of
your test device.
This manual contains descriptions of the main functions of AccuScreen.
We recommend that you make yourself familiar with the following issues:
Installation
Unpacking and Installation ►11, and Preparing for testing ►28 describes how to unpack AccuScreen, prepare and con-
nect cables, and set up the device.
Safety
This manual contains information and warnings which must be followed in order to ensure the safe performance of
AccuScreen. Local government rules and regulations, if applicable, should also be adhered to at all times.
Please see the overview of device labelling in Overview of AccuScreen ►11 and read the warning notes in Standards and
Safety ►86.
Training
It is recommended that you read this manual before you start operating AccuScreen so that you become familiar with the
device before testing on a patient.
To obtain a free printed copy of the user documentation, contact Natus (www.natus.com).
Maintenance and cleaning
For instructions on how and when to clean AccuScreen and its accessories, please see Maintenance and Cleaning ►80.
1.8 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses pre-
cautionary statements as follows:
Warning •Indicates that there is a risk of death or serious injury to the user or patient.
Caution •Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note •Indicates that you should take special notice.
MADSEN AccuScreen 9
1 Introduction

1.8.1 Navigating this manual
Menus, icons and functions to select are shown in bold type, as for instance in:
• Press the OK button.
10 MADSEN AccuScreen
1 Introduction

2 Unpacking and Installation
2.1 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the packing material in which they were
delivered. If you need to send the device in for service, the original packing material will protect against damage dur-
ing transport, etc.
2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is
incomplete, contact your local distributor.
2.2 Overview of AccuScreen
2.2.1 Front and rear of AccuScreen
A. On/Off switch
B. Touch screen display
C. Power and charging status light indicator
D. Test cavity
E. Button for opening battery compartment
F. Cover on battery compartment with serial number label
MADSEN AccuScreen 11
2 Unpacking and Installation

2.2.2 Top and bottom of MADSEN AccuScreen
Top Bottom
A. Electrode cable socket
B. Probe socket & ear coupler cable socket
C. Docking Station connectors
2.2.3 The docking station
Front indicators
POWER
Lit when power is supplied to the docking station.
Lit when data is being transferred as follows:
• during transfer of data between AccuScreen and AccuLink.
• during printing from label printer
USB
Lit when docking station is connected to the PC via a USB cable.
12 MADSEN AccuScreen
2 Unpacking and Installation

Rear sockets
PC/USB
Socket for USB connection to the PC
Printer/Modem
Socket for printer/modem connection
Socket for power adapter
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2 Unpacking and Installation

2.2.4 Display
The display is a touch-screen display, where the icons and fields shown serve as buttons.
• Touch the buttons to activate a function.
Caution •Never use any type of sharp instrument on the display. If you do, reliable operation of AccuScreen can no
longer be guaranteed.
2.2.5 Ear probe
Probe cable plug
A. Probe tip B. Probe body
C. Probe cable
14 MADSEN AccuScreen
2 Unpacking and Installation

2.2.6 Electrode cable (ABR only)
A. Electrode cable plug B. Electrode clips
C. Electrode cable
2.2.7 Ear coupler cable
Ear couplers
A. Cable connector
B. Ear coupler cable
C. Blue ear coupler adapter for left ear
D. Red ear coupler adapter for right ear
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2 Unpacking and Installation

2.3 Storage
Store AccuScreen and accessories in the soft case provided to protect the equipment from damage. See also Operating
environment in Technical Specifications.
2.4 Assembly
When you receive AccuScreen, do the following before you connect the probe.
1. Insert the battery into the battery compartment. See Inserting the battery in AccuScreen ►17.
We recommend placing AccuScreen in the docking station and charging the battery fully before use. See Charging the
battery from the docking station ►19.
2. Turn on AccuScreen. See Switch on AccuScreen ►20.
3. Set the date on the device. See Time and Date setting ►71.
Now you can connect the probe, the ear coupler cable and the electrode cable as needed. See Preparing for testing ►28.
2.5 Powering
AccuScreen is powered by a rechargeable battery. The battery is charged:
• when AccuScreen is placed in the docking station. See Charging the battery from the docking station ►19.
• by the AccuScreen external charger (optional accessory). See Charging the battery with the external charger ►19.
2.5.1 The battery
The battery used in AccuScreen:
• is a Lithium-Ion rechargeable battery
• has a high capacity
• is lightweight
• has a low rate of self-discharge
• can be charged continuously
• guarantees approximately 8 hours of operating time
On delivery, the battery is charged approximately 50%. We recommend that you charge the battery fully before starting to
test.
Use only the battery type and docking station stated in Power supply and battery ►97 and 1077 docking sta-
tion ►97.
See Battery safety and maintenance ►84.
Battery Storage
If the battery is to be stored for a long time, it is recommended that it is stored with approximately 50% remaining battery
capacity and in a dry and cool place. Storing the battery in a refrigerator can be recommended.
16 MADSEN AccuScreen
2 Unpacking and Installation

If the battery is stored with full battery capacity and at room temperature or warmer, the battery will permanently
degrade with about 10-20% after one year.
2.5.2 Inserting the battery in AccuScreen
1. Push the button of the battery compartment upwards.
The battery compartment pops out.
2. If needed, remove the battery.
3. Place a new, charged battery in the compartment.
– Hold the battery so that the arrow with the text “Insert this direction” points
downwards towards the bottom of the compartment.
4. Close the compartment.
2.5.3 Battery status
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2 Unpacking and Installation

• The battery symbol is shown in the top right corner of the display, enabling you to view the status of the battery at all
times.
• When less than 25% of the battery capacity remains, we recommend that you change the battery and recharge it as
soon as possible.
• When the battery level drops below 10%, test results can be viewed, but testing is no longer possible.
Symbol Remaining battery capacity
100 - 75% The battery is fully charged.
75 - 50%
50 - 25%
25 - 10% The battery should be charged.
10 - 0% The battery is very low and testing is not possible.
If the necessary minimum voltage should drop, AccuScreen switches off automatically. Recharge or change the battery
as soon as possible.
2.5.4 Powering the docking station
The AccuScreen docking station is powered through an adapter from the mains outlet.
Warning •In order to comply with the safety requirements for a medical device system, connection to the docking sta-
tion must always be done outside the patient area (min. 1.5metres/5ft from the patient).
You will find an adapter plug kit when you unpack AccuScreen. The adapter plug kit contains a range of adapter plugs you
can choose from to fit your mains outlet.
Connecting to the mains supply
1. Select the adapter plug appropriate to your mains outlet and fit it on the adapter.
2. Connect the adapter to the docking station and the mains supply. The POWER indicator will light up
green.
Caution •Electrical equipment must be positioned so that there is easy access to disconnect the power supply from
the mains.
Disconnecting from the mains supply
To disconnect AccuScreen docking station from the mains supply, simply remove the adapter plug from the mains outlet.
18 MADSEN AccuScreen
2 Unpacking and Installation

2.5.5 Charging the battery from the docking station
The battery in AccuScreen charges automatically when you place AccuScreen in the docking station.
1. Place AccuScreen in the docking station.
The light indicator on the front of AccuScreen will light up.
Front light indicator
Green • Fully charged
Orange - steady • Charging
Orange - flashing • During start-up
• When there is a battery error, for example:
– No battery inserted
– Battery inserted incorrectly
– Defective battery
Charging a fully discharged battery from the docking station takes approximately:
80% charged 4½ hours
Fully charged 6 hours
2.5.6 Charging the battery with the external charger
Caution •Use only the charger supplied by Natus.
The battery for AccuScreen can be charged by an external charger (optional accessory).
See the charger manufacturer's documentation for specifications and instructions for use.
MADSEN AccuScreen 19
2 Unpacking and Installation

3 Getting Started with AccuScreen
In the following, you will find quick instructions on how to use AccuScreen:
• Switching on AccuScreen
• Adding new patients
• Finding patients
• Editing patient data
You will find detailed instructions for preparing and testing in:
•Preparing for testing ►28
•Testing with AccuScreen ►37
3.1 Switch on AccuScreen
1. Switch on AccuScreen: Press the On/Off switch.
A start-up screen is shown, while AccuScreen performs a self-test.
A. On/Off switch
The start-up screen shows the name of the device.
The AccuScreen name is configurable (see the AccuLink User Manual).
3.1.1 Power-saving mode and automatic power-off
If you do not use AccuScreen for a certain period of time, AccuScreen will first switch to power-saving mode, and finally
switch off automatically. These periods are configurable (see the AccuLink User Manual).
• When AccuScreen is in power-saving mode, the display goes black and the power indicator lights up green.
• Simply touch the screen to reactivate AccuScreen.
3.1.2 The AccuScreen screens
Important •The screens shown in your AccuScreen depend on the configuration of AccuScreen. In the following, the
default selection and sequence of screens is shown. This is configurable; see the AccuLink User Manual.
• Main instructions for data entry screens are described in
–Entering data in AccuScreen ►74.
• Buttons are described in
–Function buttons ►75
–General buttons ►76
20 MADSEN AccuScreen
3 Getting Started with AccuScreen