otometrics Otoscan User manual

Otoscan
User Guide
Doc. No. 7-50-1420-EN/U2
Part No. 7-50-14200-EN

Copyright notice
The manufacturer authorizes GN Otometrics A/S to publish manuals approved and released by the manufacturer.
© 2017,2017GNOtometricsA/S. All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL, MADSEN, ICS and HORTMANN
are registered trademarks of GNOtometricsA/S in the U.S.A. and/or other countries.
Version release date
2017-03-22 (153432)
Technical support
Please contact your supplier.
OtoscanR to be included under Copyright notice. Awaiting response from Mette B/Tommy Bysted.
• License
This product is manufactured and sold under license from United Sciences.
Patents
This product is covered by one or more patents or patent applications as listed at: www.unitedsciences.com/patents:
1. U.S. Patent 8,715,173
2. U.S. Patent 8,900,126
3. U.S. Patent 8,900,125
4. U.S. Patent 8,900,129
5. U.S. Patent 8,900,128
6. U.S. Patent 8,900,127
7. U.S. Patent 8,900,130
8. U.S. Patent Application 14/040,973
9. U.S. Continuation Patent Application 14/538,994
10. U.S. Patent Application 14/041,943
11. U.S. Patent Application 14/049,542
12. U.S. Patent Application 14/049,538
13. U.S. Patent Application 14/049,666
14. U.S. Patent Application 14/049,530
15. U.S. Patent Application 14/049,687
16. U.S. Patent Application 14/049,678
17. U.S. Patent Application 14/049,504
18. U.S. Patent Application 14/049,518
19. U.S. Patent Application 14/150,863
20. U.S. Patent Application 14/462,619
21. PCT Patent Application PCT/US2012/029806
22. PCT Patent Application PCT/US2013/028347
23. Australian National Phase Patent Application 2012231140 Corresponding to PCT Patent Application PCT/US2012/029806
24. European National Phase Patent Application 12760319.9 Corresponding to PCT Patent Application PCT/US2012/029806
25. Chinese National Phase Patent Application Corresponding to PCT Patent Application PCT/US2012/029806
26. South Korean National Phase Patent Application 10-2013-7027859 Corresponding to PCT Patent Application
PCT/US2012/029806
27. Japanese National Phase Patent Application Corresponding to PCT Patent Application PCT/US2012/029806
28. Canadian National Phase Patent Application Corresponding to PCT Patent Application PCT/US2012/029806
29. Hong KongNational Phase Patent Application Correspondingto PCT Patent Application PCT/US2012/029806
30. PCT Patent Application PCT/US2014/59512
31. PCT Patent Application PCT/US2014/59521
32. PCT Patent Application PCT/US2014/59535
33. PCT Patent Application PCT/US2014/59530
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Table of Contents
1 Introduction 4
2 Intended use 5
3 Unpack and get acquainted with Otoscan 6
4 Log into the system 14
5 Manage patient records 16
6 Prepare patient for scanning 20
7 The scanning session 23
8 Manage patient orders 34
9 Log out 36
10 Cleaning, service and maintenance 36
11 Troubleshooting 39
12 Standards and warnings 42
13 Technical specifications 45
14 Other references 49
15 Manufacturer 49
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1 Introduction
Otoscan is an end-to-end ear scanning solution that provides a safe, easy and forward thinking way to make digital impres-
sions for molds or in-ear devices. At the same time, it eliminates clinical concerns related to traditional silicone impres-
sions, such as risk to the patient, patient discomfort, and inconsistent outcomes.
The primary function of Otoscan is to make digital 3D scans of the patient's ear canal and pinna, to be used in the man-
ufacture of custom in-ear devices. The scans are transformed by the scanning software into image files that are ready for
use in 3D modeling. Simultaneously the scanner performs video otoscopy during the scanning process, in order to help the
user navigate the scan in the patient’s ear. Also see: Intended use ►5
Scanner and software
The scanner is used in connection with the Otoscan Session Manager installed on the PC. The Session Manager is com-
prised of a Patient module and the Scanning module.
The Session Manager synchronizes data with the Otoscan online Portal, from where patient scans can be accessed, annot-
ated, and subsequently submitted electronically as custom orders to manufacturers or ear mold laboratories.
1.1 The Otoscan Set
The Otoscan set consists of:
• A dedicated laptop with pre-installed Otoscan software
• A hand-held scanner
• A cradle for secure docking of the scanner
• A headset for precise targeting of the ear and ear canal during scanning
•Also available: A training kit for practicing the scanning technique.
The individual parts of the set are further described in the following sections.
Fig. 1 The Otoscan set
A. scanner
seated in it's desktop cradle
B. Patient headset.
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1.2 Typographical conventions in this manual
Read the User Guide
Read the present User Guide (manual) before using the scanner for scans involving people.
Where relevant, the procedure to be followed is listed at the beginning of the chapter, and a detailed description of the
individual steps can be found in the sections following the procedure.
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.
2 Intended use
2.1 Intended medical indication
The primary application of the scanner and Session Manager is to make digital three dimensional (3D) impressions (scans) of
the patient's ear(s) for manufacturing ear molds and custom hearing instruments.
The 3D impression can also be used for manufacturing customized noise protection headset/earplugs or swim plugs.
The secondary application of this product is video otoscopy. The video otoscope function is mainly to help the user nav-
igate the scan in the patient’s ear.
To help the user in navigation of the scanner, a display is provided on the scanner device.
2.2 Intended user profile
The user must have received relevant training according to local regulations. Typical users of this type of product are
trained audiologists and hearing instrument dispensers.
Can we use the following text from OTOcam instead, as standardization reduces translation costs:
"Audiologists, hearing instrument dispensers, ENT doctors and other trained personnel. Please note that local regulations
may define users for video otoscopy differently. Local regulations must be complied with at all times. "
NOTE: This will probably require updating of hazards and risks documentation, but they currently seem to disagree any-
way:
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"1093 Hazard Analysis_7-38-00193 Rev01" states "audiologists or doctors" trained..., whereas the "1093 OTOscan Regu-
latory Plan_7-38-00190 Rev00" states "Typical users of this type of product are trained audiologists and hearing instrument
dispensers.”
2.3 Intended conditions of use
The scanner is intended for transient use.
The external ear canal of the patient is the only intended body orifice for scanning.
3 Unpack and get acquainted with Otoscan
Package 1: Laptop Package 2: scanner and headset Package 3: Training aids
Fig. 2 To avoid damage always leave the scanner in cradle when not in use!
Visually inspect the equipment for possible damage
When you open each package, visually inspect the contents for possible damage.
If damage has occurred, do not put the damaged device into operation. Contact your local distributor for assistance.
Check the packing list
Check the packing list to make sure that you have received all necessary parts and accessories. If your package is incom-
plete, contact your local distributor.
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Keep all packing materials
Keep all packing materials in case you need to send the device in for service. The original packing material will protect
against damage during shipping.
3.1 The Otoscan PC
The PC is dedicated to be used exclusively for the Otoscan procedure. It has the dual function of powering the scanner dur-
ing use and controlling the scanner and the data derived from the scanning process.
The software components installed on the PC include an application known as the “Otoscan Session Manager” containing
the Patient module (database) and the Scanning module. When online, the patient database will be synchronized with a
second database on an online portal known as the Otoscan Portal.
You will typically use the PC for management of patient data and for initiating and evaluating the scans.
During the scanning, a smaller duplicate of the PC screen is available on the hand-held scanner. This touch-enabled screen
on the scanner allows for direct control of the scanning process.
Installation procedure:
1. Unpack the PC carefully (See below)
2. Set up the PC on a suitable desktop next to the seating for the patient (See below)
3. Power the PC: Connect it to an electrical outlet. (See below)
Unpack the PC
• Carefully remove all packaging and keep it for possible later use. Also, keep the enclosed insert note at hand for later
reference, if required. It describes how to start the PC and find the present user guide.
Setting up the PC
• Place the PC on a suitable desktop within easy reach from the patient workspace and leave a space for the scanner
next to it. Make sure that the PC's air vents are not obstructed.
• Consider placing the PC screen in full view of the patients, so they can follow the scanning process. If you decide not
to do so, place it entirely out of view of the patients, as otherwise they may inadvertently turn their head to follow
the scanning process.
The Otoscan Session Manager and all required accessories have been installed from the factory on the PC. Therefore, it
arrives fully functional and there is nothing you need to set up before it is ready to use.
All you need to get started is a log-in and a password, which should be available from the clinic's Otoscan administrator.
For instructions on how to use the Otoscan software units, see the sections:
•Log into the system ►14
•Manage patient records ►16
•The scanning session ►23
•Manage patient orders ►34.
Powering the PC
• Connect one end of the power supply cable to the power inlet of your PC, and the other end to an electrical outlet.
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Battery operation
If required, the PC can run on it's built in battery for several hours before it needs to be connected to an electrical outlet
for recharging. Do not let the PC discharge entirely before recharging it.
Further instructions
If you need further instructions, e.g. on how to connect the PC to an electrical outlet, how best to preserve battery life, or
how to use general functions on the PC, please refer to the user instructions from the PC manufacturer, which are supplied
with the PC.
3.2 The Otoscan cradle
Unpacking the Otoscan cradle
As the cradle serves as protection for the scanner during shipping, please refer to the section The scanner ►8for unpack-
ing instructions.
Using the cradle
The cradle is designed for safe docking of the scanner when not in use. The inside back wall of the cradle is covered by a
dotted pattern. Prior to each scan, the scanner will use this pattern for a self-test of the functionality of the scanner.
When the scanner is not in use, always place it in the cradle to protect the probe tip.
Always park in cradle ... - or else:
Fig. 3 To avoid damage always leave the scanner in cradle when not in use!
3.3 The scanner
Procedure:
1. Carefully unpack the scanner and cradle
2. Place the scanner and cradle next to the PC
3. Store packaging for later use
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Carefully unpack the scanner and cradle
Remove all packaging and note that the scanner probe tip is fragile! Be careful when removing the tape that keeps the
scanner attached to the cradle and when handling the scanner once it is free.
Place the cradle and scanner next to the PC
Keep the scanner in the cradle and place the set on a stable desktop next to the PC. Choose a location where you will
have convenient access to the scanner when it is parked in the cradle. Also, ensure that you have a clear view of the PC
screen during the scanning session. This will be useful when you pause to evaluate the scanned image, if you prefer to see
it on the larger screen, and when you finalize the scanning session.
Caution •The probe tip is fragile. To avoid damage always leave the scanner in the cradle when not in use.
Store packaging for later use
Keep all packing materials as the original packing material will protect against damage during shipping, for example when
sending the scanner in for the annual calibration check.
3.3.1 Connect the scanner
Otoscan is fully assembled on delivery, and you simply have to connect cables.
Caution •To connect the scanner to the PC, use only the supplied USB cables.
Connect the USB cables that are attached to the scanner into the computer’s two USB 3.0 ports on the side of the PC:
• Plug the connector with the two cables into the front port and the connector with the single cable into the next port
towards the back.
Fig. 4 Connect the scanner to the PC at the USB ports
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3.3.2 The scanner components
Operating principle
The scanner is an advanced unit with built-in laser scanners and cameras. These components work together to capture
accurate scans of the ear canal and pinna in order to form a 3D digital impression of the ear.
The patient headset (see The Otoscan accessories ►13) serves as the reference point for the entire process.
During scanning, the two cameras placed on either side of the probe continuously track the position of the headset rel-
ative to the 3D data that is being returned by the scanners. This allows the system to build an accurate 3D model of the
ear canal and the required parts of the pinna. See Fig. 5 and Fig. 6.
Fig. 5 The hand-held scanner, seen from front
A. Tracking Cameras
Cameras on either side of the probe detect the headset
worn by the patient. The cameras are used to track the
position of the scanner in relation to the patient’s ear.
To function properly, the cameras’ view of the headset
must remain unobstructed.
B. Ring Laser
Scans outwardly from the tip of the probe (E). Scans the
canal (in Canal Ring mode) and curved portions of the
pinna (in Concha Ring mode) such as the helix, sidewalls,
and tragal notch.
C. Pinna Line Laser
Scans in front of the probe tip in a horizontal line, similar
to a bar code scanner. It is used for scanning the flatter
parts of the pinna, such as the center part of the concha
bowl, and ridges at the edge of the concha.
D. Trigger Button
Selects the most common next action, based on the cur-
rent state of the device. This action appears highlighted
on the screen. For example, you will use the trigger to set
the depth gauge and start a scan. During a scan, press the
trigger to pause the scan.
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Fig. 6 The hand-held scanner, seen from rear
E. Probe
The probe is the portion of the scanner which can be
inserted into the ear canal. It contains lighting, the video
otoscope camera, and the Ring laser scanner. It is fragile
and can break if the device is not seated in the cradle
while not in use.
F. Light Indicator
The color of the Otoscan logo indicates the status of the
scanner. The device is on and ready when the light is
green. See the Legend: Light Indicator colors ►11
G. Touchscreen
The screen is touch enabled and serves as the primary
interface used throughout the scanning process. It can be
used in combination with the trigger. All aspects of the
procedure are shown on the screen, including the 3D
scan image, the video otoscopic view, depth readings, and
messages.
Legend: Light Indicator colors
GREEN = Ready/Standby
BLUE = Scanner active or in Scanning mode, with tracking
YELLOW = Scanner in Scanning mode, but tracking lost (Action required: Correct scanner position vs. headset ring)
ORANGE = Depth warning and any error condition (Action required: Correct the error)
3.3.3 How to switch the scanner ON and OFF
The Scanning module controls the power to the scanner. This means that the scanner will be turned on automatically
when you initiate a scan from the PC Scanning module.
To access the Otoscan software application, you will need a registered user name and a password. See Log into the system
►14
Warning •Do not stare into the light beam, or point the light beam in the direction of other people’s eyes. It can
damage the eyes.
To switch the scanner ON
1. Turn on the PC and log in
2. Open or create the relevant patient record
3. From within the record, select Begin Scan.
This will cause the scanner to automatically turn on and be ready for scanning.
See Begin the 3D scan ►24
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To switch the scanner OFF
The scanner automatically switches off a short time after completion of a scanning session.
Note •If you happen to unplug the scanner from the PC ;during use, this will switch off the scanner but not the Scan-
ning module. It is possible to plug the scanner back in and continue the scanning session.
3.3.4 How to use the Otoscan trigger and touchscreen
Operating methods
The prevalent way to control the scanner is by means of it's touchscreen and trigger. When using the scanner, make sure
that your hand or fingers do not cover the tracing cameras or laser source. See points A-D on Fig. 5
Using the touchscreen
During scanning, the screen on the scanner displays a duplicate of the Scanning module shown on the PC. This allows for
operation of the scanner by means of it's touchscreen, while the display on the PC may be convenient in instances where
you want to see a larger representation of the scan. When appropriate, you can also make scanner selections on the PC
screen by means of a PC mouse or the PC's touch pad.
Caution •The Otoscan touchscreen display may get hot during heavy use. Do not touch the display surface for longer
than 1 minute.
Using the trigger
The Otoscan trigger is located on the handle of the device. See point D on Fig. 5 It allows the user to start or pause the
scan as well as proceed to next steps in the scanning process. An activation of the trigger will always select the highlighted
button on the touchscreen. Generally, the highlighted buttons on the screen will guide the user through the normal scan-
ning procedure.
In the example in Fig. 7. below, which displays an ongoing scanning, the trigger will activate the Pause button.
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Fig. 7 The Pause button is highlighted on the screen (by means of a thin blue square).
Stabilizing the scan
The scanner is designed to allow single-handed use, but in order to improve scanning precision and minimize fatigue, you
may choose to use a proper bracing technique.
In order to maximize safe operation of the scanner with patients, make sure that your work space is free of obstacles,
including on the floor.
3.4 The Otoscan accessories
Unpacking the accessories
Unpack the headset and (if relevant) optional training material and place them next to the scanner.
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3.4.1 The headset
The patient-worn Otoscan headset is essential for the scanning
process, as it serves as the target for the two cameras on the
scanner, which keep track of the exact location of the ear during
the scan.
It is, therefore, crucial for a successful scan that the headset is
placed correctly, and that it remains in place during the entire
scan. See Place the Otoscan headset ►22
In order to facilitate correct placement, the headset is designed
for scanning of one ear. When scanning the other ear (if
required), the headset must be repositioned to target that ear.
This procedure is found to maximize efficiency and maintain
high accuracy for both scans.
Fig. 8 The headset, placed correctly at the ear of
the patient
3.4.2 Training material
If optional training material (such as a training ear) was enclosed with your order, place the training ear in a convenient loc-
ation for training such as adjacent to the scanner.
Along with other training, the training ear will provide you with a safe way to get acquainted with the operation of the
scanner and Scanning module.
3.5 Storage of the Otoscan units
If you need to store the Otoscan devices, follow these guidelines:
• Store Otoscan and accessories in the boxes provided to protect the equipment from damage.
• Store Otoscan and accessories in a dry environment.
4 Log into the system
User ID and password
All Otoscan users will need a user ID (the user’s email address) and password in order to access the Otoscan Session Man-
ager and the web Portal. The Portal is accessed via the Session Manager.
Initially, the primary administrator for a clinic will receive an email with instructions on how to log into the Oto-
scan;Session Manager and web Portal. The primary administrator can then add other users that need access to the applic-
ation.
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4.1 Log-in
First log-in
Each new user who has been set up by the administrator, will receive an email with instructions on how to log into the
Otoscan Session Manager and online Portal.
Log-in procedure
1. Start the PC and double-click the Otoscan icon: See Start the PC and open Otoscan ►15.
2. Wait while the system checks for new software. See Wait while the system checks for new software ►15.
3. Log into the system. See Log into the system ►15.
Start the PC and open Otoscan
• Press the ON/OFF button of the PC to turn it on.
The Otoscan icon is located on the Windows taskbar at the bottom of the screen.
• Click this icon to start the Session Manager.
Wait while the system checks for new software
When the Session Manager starts, it will check for updates to the software. If an update is available, we recommend that
you let the system install it. We do, however, recognize that updates may come at an inconvenient time and, therefore,
you are given the option to skip the update a limited number of times. However, in cases where the update is critical for
continued performance, you will not be allowed to skip the update.
• To start the update, click the large yellow down arrow.
• To continue without starting the update, just log into the system.
Log into the system
The system will prompt you to enter your user name and password:
1. Enter the user name and password that you have received from the Otoscan administrator in
your clinic.
2. Click the button Login.
Note •Note: If you leave the PC idle for 20minutes, you will automatically be logged out.
See Log out ►36 for instructions on how to log out and close down after use.
Forgotten password
If you have forgotten your password, do as follows:
• Click the link below the Login button: Forgot Password
You will be redirected to another window, where you can enter your e-mail address.
You will then receive an e-mail with instructions on how to reset the password and create a new one.
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4.2 Overview of the Otoscan software application
The Otoscan Session Manager is divided into a Patient module, where patient data is created and kept updated, see Man-
age patient records ►16, and a Scanning module, see The scanning session ►23.
The Scanning module can only be started from within a patient record. While performing a scan, the Scanning module can
be operated directly from the scanner.
4.3 Overview of the Otoscan Portal
The primary function of the Portal is for you to transmit scans and images to hearing instrument manufacturers and ear
mold laboratories in association with hearing instrument orders.
You have direct access to the Otoscan Portal from the Otoscan Session Manager.
Whenever the PC is online and a user is logged in, the application will synchronize the patient record in the local database
on the PC with the corresponding data records on the Portal.
Note •While you are working on the Portal, the Session Manager on the PC remains open in background.
You can switch between the Portal and the local application by means of the keys Alt + Tab (hold down the Alt key
while you press Tab). Alternatively, you can click the relevant icons on the task bar at the bottom of your PC screen.
Note •If the Session Manager is left idle in background for 20minutes, you will automatically be logged out. This is
done in order to minimize the risk of unauthorized access to the data.
See Manage patient orders ►34 and the Otoscan Portal manual for further information.
4.4 Otoscan training opportunities
We wish to ensure that you get a good start using the Otoscan system, and that you quickly gain confidence in using the
equipment in a safe and efficient manner. Therefore, a range of training opportunities and training materials are available.
Please consult your supplier for information on available training opportunities in your area..
Training ear
A model of an ear, permanently fitted with a ring from a headset, is available as an optional extra for training purposes.
This ear provides a safe and convenient opportunity to experiment with the scanning process, until you feel that you have
gained sufficient proficiency to use the scanner with real people.
5 Manage patient records
The Otoscan Session Manager and Portal store all patient data, saved scans and orders in patient records.
Whenever the PC is online and a user is logged in, the application will synchronize the patient record in the local database
on the PC with the corresponding data records on the Portal.
It is good practice to check if a patient is already in the database, before proceeding to create a new patient record.
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Open or add a patient record:
• Open a patient record. See Open patient record ►17
• If no record exists for the current patient, create a new record. See New patient record ►19
More options:
• Modify a patient record. See Modify patient record ►18
• Deletion of patient records. See Deletion of patient records ►19
5.1 Open patient record
This description covers the Session Manager comprising the Patient module and Scanning module. For instructions on how
to work with patient records within the Portal, see the Portal user manual.
The Patient list
When you open the Session Manager, the Patient module with the list of Patient records appears.
Fig. 9 The list of Patient records
To find an existing patient record in the Patient module you can either use search filters or sort the list by the column
headers:
Use filters to search for a patient
1. If the list is long, use the filter selections in the left panel to search for the patient:
Enter either the patient's name, ID, Date of Birth (DOB), or latest activity with the patient in the appropriate fields.
The list on the right will narrow down as you type.
If you need to reset the filter in order to make a new search, click the button Clear Filter.
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Fig. 10 Example: List sorted by starting to write the patient's last name in the Patient Name field
2. When the patient is found, click the patient name in the Patient Name column to open the record.
Use column headers to sort the patient list
Alternatively, you can click one of the column headers to have the list sorted according to the selected column:
• The first click on a column header will sort the list in ascending order.
• A second click on the column header will reverse the sort order.
Modify patient record
If you need to make changes to a patient record:
1. Open the relevant patient record.
2. In the top left corner, click the pencil icon.
3. In the Edit patient window now appearing, make the required changes.
4. Click Save to save your changes, or Cancel to quit without making changes.
Fig. 11 The Patient record window. In this example, a scan for left ear has been made at an earlier stage.
New scans will not overwrite earlier scans. If more scans exist for an ear, the other scans can be found via the
drop-down list at the top of each frame, for the Left or Right ear respectively.
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Close patient record
To close a patient record and return to the Patient List, click the < Patient List button in the top left corner of the patient
record.
Deletion of patient records
It is not possible to delete a patient record once it has been created.
If a patient record contains data that needs correction, use the above option Modify patient record ►18 to correct it.
5.2 New patient record
If the patient record is not already in the system, a new record must be created in the Patient module (or on the Portal)
prior to scanning the patient.
To add a new patient in the Patient module:
1. Click the Add Patient button in the top bar.
2. Enter all relevant patient information.
Required fields (noted by an asterisk *) are: Last name - First name (or Patient ID), Date Of Birth (DOB), and Gender.
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3. Click Save.
A new patient record is now created in the Patient module. This is where orders and scans for the new patient will be
stored and kept available for viewing or editing.
• If you need to edit this information, click the Pencil icon next to the patient name in the top bar.
• If you want to return to the Patient list, click the <Patient List button in the upper left corner.
For instructions on how to add a patient record in the Portal database, please see the Otoscan Portal manual.
6 Prepare patient for scanning
Procedure
1. Otoscopy and earwax removal. See Perform otoscopy and ear canal cleaning ►20
2. Instructions to patient. See Instruct the patient ►21
3. Place the headset correctly. See Place the Otoscan headset ►22
4. Position the patient for secure scanner operation. See Position the patient for secure scanner operation ►23
6.1 Perform otoscopy and ear canal cleaning
In the following sections, the individual parts of the pinna are referred to as indicated on the below figure.
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