Bausch OccluSense User manual
INITIAL SETUP
In the OccluSense®-iPad-App select ‘Settings’ and tap
on ‘Initial setup’.
Switch on the handheld.
(press the pink operating button 1)
Your handheld first creates its own network (SSID)
which is shown with the password (WEP) in the
display.
Tap 'Start' in the OccluSense®-iPad-App to initiate
the setup process and type the WEP password into
the dialog box.
Confirm the following dialog with ‘Join’.
WLAN SETUP
Confirm the following dialog with ‘Yes’ to connect the
OccluSense®handheld device with your WLAN.
A screen opens with three steps to be performed.
Tap on ‘Next’ to start the process. Now enter your
network name (the last selected SSID is suggested)
and your WLAN password.
Once the data has been entered, tap ‘Next’.
The OccluSense®-iPad-App establishes a connection
to the handheld via this network.
A successful connection between the handheld and
the wireless network is indicated by green signal bars
and the first 6 characters of the wireless network in
the upper left corner of the handheld display.
If the connection between the handheld and the
wireless network has failed, the connection status is
indicated on the handheld display by transparent
signal bars. In this case reset the handheld (manual
chapter 19.2) and start the initial setup again.
Quick Start Guide
PREPARATION
Make sure your iPad is connected to your wireless
network and that your wireless network supports the
2.4 GHz (IEEE802.11 b/g/n) frequency. Have your
WLAN password ready.
Install the OccluSense®-iPad-App
www.occlusense.com/install
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REGISTRATION OF THE SYSTEM
Before registering your system, make sure you have
an internet connection.
We recommend to register your system immediately
to ensure full functionality and extended use. If this
will not be done, the system will automatically return
to demo mode after 14 days.
To register your system, open the OccluSense®-iPad-
App.
Tap on ‘Settings’ in the menu.
Then go to ‘Handheld registration’.
Fill in the registration form. Please fill in the following
fields:
Country, name, first name, street, postal code, city
and your email address.
Tap the ‘Register’ button to send your registration
data to your e-mail address.
A confirmation email will be sent to your email
address, which you must open and confirm.
Restart the OccluSense®-iPad-App. If your registra-
tion was successful, a green checkmark will appear
in the OccluSense®-iPad-App.
Your system is now registered and ready to use.
TECHNICAL REQUIREMENTS FOR THE
WIRELESS LOCAL NETWORK (WLAN)
• 2.4 GHz WLAN-Standard IEEE802.11 b/g/n
(5 GHz is NOT supported)
• No MAC filter activated
(MAC = Medium Access Control)
• DHCP server with two free IP addresses available
OccluSense®is a network device - If you have any
problems connecting the OccluSense®to your
network, please contact your system administrator.
SUPPORT
help.occlusense.com
Multilingual Phone Support
Europe
+49-221-98259010
The Americas
+1 (844) 633-4002
Japan
+81-50-3101-4161
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Instructions for Use
Bausch and OccluSense®are trademarks of Dr. Jean Bausch GmbH & Co. KG, registered in the EU and other countries.
Apple, Mac, iPad, iPad Air, iPad mini, AirDrop, iTunes are trademarks of Apple Inc.,
registered in the U.S. and other countries.
All other trademarks are the property of their respective owners.
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INDEX
Symbols..............................................................................................................................8
Terminology, Hardware requirements iPad................................................................9-10
GENERAL INFORMATION
1 Medical products manufacture....................................................................................11
2 Medical products distributors......................................................................................11
3 Intended Use...........................................................................................................12
4 Device description (components, etc.)....................................................................12
4.1 Operating and functional elements of the OccluSense-System........................13
4.2 System features...............................................................................................14
5 Contraindications.........................................................................................................15
6 Expected clinical benefit.........................................................................................15
7 Precautions / Safety Instructions............................................................................16
PREPARATION
8 Installation of the OccluSense®-iPad-App ..................................................................17
8.1 Battery Charging......................................................................................18-21
OccluSense®-iPAD-APP
9 Overview..................................................................................................................22
9.1 Intended use of the OccluSense-iPad-App......................................................22
9.2 Overview of the OccluSense-iPad-App.............................................................22
9.3 User manual.....................................................................................................23
INSTALLATION
10 First Use...............................................................................................................24
10.1 Demo Mode...................................................................................................24
10.2 Initial Setup.................................................................................................25
10.2.1 Switch on the handheld................................................................................25
10.2.2 Start the initial setup..............................................................................26-27
10.2.3 Integration into your own WLAN network.....................................................28
10.2.4 Registration of the system.......................................................................29-30
10.3 Administration of OccluSense handheld devices...........................................31
10.3.1 Rename handheld........................................................................................31
10.3.2 Disconnect handheld....................................................................................31
10.3.3 Pairing of the handheld with the OccluSense-iPad-App................................32
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SAFETY
11 Safety Check...........................................................................................................34
12 Function test......................................................................................................34-35
PATIENT MANAGEMENT
13 Manage patient data...............................................................................................36
13.1 Overview..........................................................................................................36
13.2 Create patient..............................................................................................37
13.3 Edit patient data..........................................................................................38
13.4 Delete a patient’s data.................................................................................38
RECORDINGS
14 Start a recording....................................................................................................39
14.1 General........................................................................................................39
14.1.1 Switch off handheld.....................................................................................40
14.1.2 Insert Sensor...........................................................................................40-41
14.1.3 Switch on the handheld....................................................................................42
14.1.4 Check WLAN connection...............................................................................42
14.1.5 Check if sensor is ready for recording.............................................................43
14.2 Set a patient active.........................................................................................43
14.2.1 Patient data..................................................................................................44
14.3 Recording modes.............................................................................................45
14.3.1 Recording and Live-Mode........................................................................46-47
14.4 Recording of the masticatory pressure distribution......................................48
14.4.1 Insert the sensor into the patient’s mouth.......................................................48
14.4.2 Recording.....................................................................................................49
14.4.3 Finish recording.......................................................................................50-51
EVALUATION OF RECORDINGS
15 Viewing recordings.......................................................................................................52
15.1 Overview..................................................................................................52-55
15.2 Resizing, turning and tilting the view...........................................................55
15.3 Playing recordings........................................................................................56
15.4 Filtering.......................................................................................................57
15.5 Viewing recorded data...................................................................................58
15.6 Additional visualization options........................................................................59
15.7 Renaming recordings and adding notes........................................................60
15.8 Fullscreen........................................................................................................61
MANAGE RECORDINGS
16 Manage and export recordings................................................................................62
16.1 Play back recordings...................................................................................63
16.2 Compare recordings.................................................................................63-64
16.3 Export recordings and snapshots.................................................................64
16.4 Export recordings as video..............................................................................65
16.5 Export data via iTunes PC/Mac software.......................................................66
16.6 Export patient’s data via AirDrop..................................................................67
16.7 Import.............................................................................................................67
SETTINGS
17 Menu ”Settings”......................................................................................................68
17.1 Recording settings.......................................................................................68
17.2 Handheld firmware (and updates)................................................................68
17.3 Terms and conditions...................................................................................68
18 Menu “Imprint”.......................................................................................................68
TROUBLESHOOTING
19 Basic troubleshooting..................................................................................................69
19.1 Damages of the handheld............................................................................69
19.2 Reset to factory default....................................................................................69
19.3 Connection lost after Firmware Update........................................................69
19.4 Entering wrong WLAN credentials..................................................................69
19.5 Troubleshooting table..............................................................................70-73
CLEANING
20 Cleaning and disinfection..........................................................................................74
20.1 Handheld.........................................................................................................74
20.2 Charging Station..............................................................................................75
20.3 Test-Sensor....................................................................................................75
20.4 Reusability...................................................................................................75
MAINTENANCE
21 Batteries, electrical safety, software updates..........................................................76
21.1 General..........................................................................................................76
21.2 Replacing the batteries............................................................................76-77
21.3 Software-Updates..........................................................................................78
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NOTICE
22 Transport & Storage................................................................................................78
23 Expected lifetime....................................................................................................78
24 Disposal Instructions................................................................................................78
25 Electromagnetic Compatibility.................................................................................79
26 Warrenty.................................................................................................................80
27 Customer Service....................................................................................................80
28 Spare parts...............................................................................................................81
29 Notification of incidents..........................................................................................81
30 Declaration of Conformity............................................................................................82
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Symbols
Some chapters describe usage procedures. In order to see which action of the
OccluSense®-System is required, the following symbols are used:
In compliance with relevant EU directives
Follow Instructions for Use!
Do not reuse!
Medical Device Manufacturer
Order Number
Unique Device Identifier
Serial Number
LOT Number
IP Protection Class
Expiry date [yyyy-mm-dd]
Waste electrical and electronic equipment (WEEE) must be disposed of
separately. These must not be disposed of with normal household waste.
Applied part of TYPE B, IEC 60601-1
Do not use if package is broken!
Do not expose to heat!
User interaction with the handheld
User interaction with the iPad
Interaction with the patient
Class II
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WEEE-Reg-No.: DE 11349707
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