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30 Declaration of Conformity

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Declaration of Conformity

The manufacturer of the products according to this declaration is:

Dr. Jean Bausch GmbH & Co. KG

Oskar-Schindler-Straße 4

50769 Cologne

Germany

Directives and standards to which the conformity is declared:

Directive 93/42/EEC (MDD)

Directive 2007/47/EC
Directive 2014/53/EU

EN 60601-1:2006 + A1:2013

EN 60601-1-2:2007

EN 60601-1-6:2010 + A1:2015

EN 62304:2006 + A1:2015

Products for which this conformity is declared:

Bausch OccluSense Set BK 5000

Bausch OccluSense Handheld BK 5001

Bausch OccluSense Sensors BK 5025
Bausch OccluSense Sensors BK 5035

Product classification:

Class I according to directive 93/42/EC including directive 2007/47/EC annex IX, rule 5 & rule 12

Conformity assessment procedure according to:

Annex VII of the directive 93/42/ECC (MDD)

Dr. Jean Bausch GmbH & Co. KG hereby declares that the products mentioned above, meet the require-
ments of the Directive 93/42/ECC (MDD) and the Directive 2007/47/EC for medical devices as well as the
Directive 2014/53/EU for radio equipment.

The technical documentation which meets the requirements for verification of compliance of the above men-
tioned directives and standards is documented in part A and B of the technical file and is available for the
regulatory authorities for medical devices.

Validity of this declaration:

This declaration is valid from 2018-06-01 to 2020-05-25.

_____________________________________
Signed by: André Bausch
Position: General Manager of Dr. Jean Bausch GmbH & Co. KG

Date of signature: 2018-06-01
Place of signature: Cologne - Germany

Dr. Jean Bausch GmbH & Co. KG

Oskar-Schindler-Str. 4

D-50769 Köln - Germany

Tel: +49 (221) - 70 93 6-0

Fax: +49 (221) - 70 93 6-66

www.bausch.net

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Содержание OccluSense

Страница 1: ...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 i...

Страница 2: ... 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 Con...

Страница 3: ...Instructions for Use ...

Страница 4: ...an 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 2 ...

Страница 5: ...3 ...

Страница 6: ...ation 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...

Страница 7: ... 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 tilti...

Страница 8: ...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 7...

Страница 9: ... 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 7 ...

Страница 10: ...rder 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 Inter...

Страница 11: ... Regarding the status of these operating instructions an evaluation unit is an Apple iPad on which the app OccluSense from the Apple App Store must be installed In order to use the app you ﬁrst have to register the system within the app The OccluSense iPad App has been developed for the following iPad models Installation on an iPad mini is not recommended In order to use the app in full functional...

Страница 12: ... s own risk It is possible to run the app on an unsupported iOS version at the user s own risk NOTE A particular notiﬁcation will pop up when the app is running on a not supported iOS or hardware The usage out of the application s technical scope will be logged for safety rea sons 10 ...

Страница 13: ... info bauschdental com Web www bauschdental com Bausch Articulating Papers Australasia Pty Ltd G P O Box 3733 Sydney NSW 2001 Australia Tel 61 2 9345 1945 Fax 61 2 9345 1955 E Mail info bauschdental com au Web www bauschdental com au Bausch Articulating Papers Japan K K 2nd Floor 1 4 2 Jonan Ikedashi Osaka Japan 563 0025 Tel 81 72 737 9501 Fax 81 72 737 9502 E Mail info bauschdental jp Web www bau...

Страница 14: ...e BK 5100 requires an Apple iPad no medical device not included 1 test sensor BK 5011 25 OccluSense Sensors BK 5025 Manual BK 5051 3 NiMH rechargable batteries BK 5013 1 Screwdriver IP 6 BK 5012 The medical device components do not contain any of the following substances Pharmaceuticals Tissues or cells of human origin or their derivatives Tissues or cells of animal origin or their derivatives wit...

Страница 15: ... Part type B 4 Handheld ME Device 5 Control button 1 pink 6 Control button 2 green 7 Sensor lid 8 Display 9 Unlock button 10 Control button 3 Reset 11 Battery compartment 12 Test sensor accessory not shown 13 Screwdriver accessory not shown 14 3 pieces AAA NiMH rechargeble batteries accessory not shown 13 1 2 3 4 5 6 7 8 9 10 11 ...

Страница 16: ...er vention in vital functions The occlusal conditions are recorded by the handheld device with inserted sensor The recorded raw data generated during the occlusion test are stored locally on the hand held device Subsequently the handheld transmits this data via wireless interface to the OccluSense iPad App The OccluSense iPad App saves and displays the received data as a recording 14 Electrical co...

Страница 17: ... representation of occlusal pressure conditions on the iPad It is possible to visualize the proportion of the masticatory forces of the entire dental arch and thus a support for the practitioner for further patient oriented therapy planning is provided Several recordings can be compared e g before and after dental treatment and can be saved on the iPad for documentation purposes Therapeutic measur...

Страница 18: ...batteries is not permitted and may result in serious injury of the practitioner or destruction of the handheld when attempting to recharge it The handheld must be disconnected from the charging station during use The charging station has to be located outside the patient s vicinity The charging station must be positioned in such a way that the plug in power supply unit is in easy reach and the sep...

Страница 19: ...Pad is required The procedure is described below NOTE The handheld comes with uncharged batteries The rechargeble batteries must be charged before ﬁrst use see chapter 8 1 The OccluSense handheld is designed for use with three AAA NiMH batteries only included The handheld can also be used with other AAA NiMH batteries than those supplied These AAA NiMH batteries must have a minimum capacity of 100...

Страница 20: ...d remove the battery compart ment cover and insert the supplied NiMH batteries into the battery compartment 4 Insert the handheld into the charging station as shown 3 Connect the plug in power supply unit to the supply voltage Rated Voltage 100 240V Rated Current 160 80mA CAUTION Batteries inserted inversely can reach high temperatures and damage the de vice 18 ...

Страница 21: ...d storage without use is foreseeable it is recommended to remove the batteries from the handheld After a storage period of the handheld with inserted rechargeable batteries of more than 3 months it is recommended to fully recharge the rechargeable batteries before reuse If the batteries have discharged after a full charge and a too low battery voltage is displayed the batteries have become unusabl...

Страница 22: ...r if you want to ensure that they are ready for use CAUTION To charge the rechargeable batteries only use the supplied charging station incl the permanently connected power supply in order to prevent damage to the handheld unit and the rechargeable batteries The use of the charging station is not permitted in the direct patient environment directly at the treatment chair Do not use a multiple sock...

Страница 23: ...permanently lit LED No warning notice Figure 4 After a full charge cycle the LED turns off The charging process takes about 3 4 hours with 1000mAh batteries The charging time may vary depending on the type of battery used and its capacity With one battery charge at least 100 recordings in 150Hz and 10 seconds mode recording time or 30 minutes of live mode can be made Figure 3 Initiating the chargi...

Страница 24: ...he app allows zooming tilting and rotating within the visualization Recorded data is automatically assigned to the respective patient and can be commented and compared with each other which makes an easy analysis of occlusion data possi ble 9 2 Overview of the OccluSense iPad App The app consists of ﬁve main menu items Figure 5 presented on the navigation bar on top of the screen The currently act...

Страница 25: ... screen is the status bar Figure 7 If the app is not connected to a handheld the status bar is empty If it is connected to a handheld the ﬁrmware version of the handheld is displayed on the left and the status of the handheld is displayed on the right Figure 7 Status bar at the bottom of the app Symbol of the handheld Handheld is connected to the app Colored dot Quality of the WLAN connection Gree...

Страница 26: ... to give a ﬁrst im pression of the app It is not possible to create new patients and recordings Please refer to chapter 13 for further information about the patient management The functionality of the settings menu is restricted to the registration menu For activating the full functionality of the app you have to leave the demo mode and connect the hand held device with the app chapter 10 Please r...

Страница 27: ...d To switch on the handheld press button 1 pink button see chapter 4 1 The WLAN net work name and password WEP are shown on the handheld display Figure 9 Figure 9 WLAN SSID and password WEP provided NOTE TECHNICAL REQUIREMENTS FOR THE WIRELESS LOCAL AREA 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 ...

Страница 28: ...ect Initial setup in the settings and tap Start Figure 10 Initial setup Now enter the WEP password in the ﬁeld Figure 11 which is shown on the display of your OccluSense handheld device Figure 9 Figure 11 Input ﬁeld for the WEP password 26 ...

Страница 29: ...andheld has been successfully connected the display shows Figure 13 This symbolizes successful connection with the OccluSense iPad app no sensor inserted and no patient data available Figure 13 Handheld is connected Figure 14 Successful setup NOTE If the horseshoe shaped symbol appears in yellow a function test is required Chapter 12 27 ...

Страница 30: ...d as the network SSID Enter the password of your WLAN network and allow the OccluSense iPad App to access the network in order to write the data to the handheld Figure 15 Instructions for the external Figure 16 Enter WLAN name and password WLAN Setup A successful connection between the handheld and the WLAN is indicated by the green bars and the ﬁrst 6 characters of the WLAN in the upper left corn...

Страница 31: ...f the app is available In case you have not yet registered the app you have access to all functions for 14 days After this period the demo mode will be reactivated and you have to register the app for further use Figure 17 Figure 17 The handheld registration form is located in the Settings menu NOTE The registration is mandatory for full functionality of the app in combination with the handheld de...

Страница 32: ... a green checkmark is being displayed After the registration process the OccluSense iPad App has to be restarted to exit the DEMO mode To do this press the home button twice iPad without home button swipe up from the bottom of the screen and swipe up the preview of the app to close it Then reopen the OccluSense iPad App NOTE If you have not received a conﬁrmation e mail check your junk mail folder...

Страница 33: ...a handheld within the registration settings section Figure 18 Tap on the ﬁeld Device name to change the text Figure 18 Screen for renaming the device Disconnect Switch device and Find device 10 3 2 Disconnect handheld In order to use another handheld the connection of the current handheld with the Occlu Sense iPad App must be disconnected This process requires the handheld to be turned on and conn...

Страница 34: ...t name is DEFAULT Once the pairing has been completed successfully the OccluSense iPad App will from now on connect automatically to this handheld Figure 19 List of available devices after switch device button has been selected NOTE Only previously disconnected handheld devices can be reconnected Chapter 10 3 2 If your device is not shown in the list of available devices please close the list pres...

Страница 35: ...ect communication between the iPad and the handheld is not possible In this case a factory reset is required Chapter 19 2 If no WLAN network is available in the dental ofﬁce the WLAN network provided by the handheld device can be used to a limited extent However an independent WLAN network is recommended in the dental ofﬁce CAUTION Integrating the handheld into an IT network that includes other de...

Страница 36: ... of the handheld the handheld has to be connected to the app ﬁrst Then tap Next and follow the instructions on the screen Figure 20 23 The function test is performed with the supplied test sensor following these ﬁve steps 1 Place the test sensor in the correct position and close the sensor lid 2 Switch on the handheld and establish a connection with the iPad 3 Follow the instructions in the OccluS...

Страница 37: ...l Figure 23 The sensor test failed 4 The result of the function test is displayed in the app If this is repeatedly negative the device must not be used In this case see chapter 19 5 Troubleshooting 5 Remove the test sensor from the handheld and place it in the storage box NOTE If the sensor test fails permanently Figure 23 please visit our support website help occlusense com 35 ...

Страница 38: ...nd editing the attached notes In this view you are also able to switch the active patient Figure 24 Patient management of the app The view is split into two sections On the left side a list of all patients is located At the top of this list you ﬁnd the tools to search the list create a new patient and to switch into edit mode where patients can be deleted or exported NOTE The search mechanism take...

Страница 39: ...cel Figure 25 Detailed view when creating a new patient in the patient management If you enter for instance asian arabic or cyrillic characters in the ﬁrst or last name ﬁeld new ﬁelds for the ﬁrst and last name will appear The new name ﬁelds only accept ASCII characters and the names entered in these ﬁelds are used for the handheld device to display the active patient ASCII characters are the lati...

Страница 40: ... save your changes tap the Done button If you want to discard your changes tap the Cancel button 13 4 Delete a patient s data To delete a patient s data the patient has to be selected ﬁrst Then tap on the Edit Pa tient symbol at the top right of the screen Finally tap on Delete To delete several patients at once tap on Edit at the top of the patient list Now you can select the patients you want to...

Страница 41: ... recording will be started and stopped by the control buttons of the OccluSense handheld only For recording a permanent wireless connection between the handheld and OccluSense iPad App is required CAUTION The handheld may only be used with closed access covers battery compartment and sensor lid AND inserted sensor in the patient environment Replacing the sensors or batteries which require to open ...

Страница 42: ...sure sensor The sensor consists of a printed electronic circuit inside featuring a sensibility of 256 pressure levels The red color coating on the outside enables the dentist to control the occlusion just like with regular occlusion test materials The total thickness of the sensor is only 60 microns which allows testing the dynamic occlusion as well The OccluSense Sensor is a single use product li...

Страница 43: ...ve the sensor from its packaging and insert it into the contact area The insertion direction and position are deter mined by the marking on the sensor as well as by positioning pins over which the sensor must be inserted 3 Close To do this press the sensor lid downwards until the snap in lugs of the release buttons snap in on both sides 41 ...

Страница 44: ... version number of the ﬁrmware Figure 27 14 1 4 Check WLAN connection Figure 28 successful WLAN connection When the handheld is switched on it automatically connects to the last conﬁgured WLAN network The connection is indicated by the colored bar diagram in the top left of the display If no network has been conﬁgured before see chapter 10 3 The connection is to be checked after switching the hand...

Страница 45: ...s inserted properly If the sensor is defective or inserted improperly the graphic on the right appears on the display Figure 30 The sensor or its position must be checked chapter 14 1 2 14 2 Set a patient active In order to start a recording the patient must be activated ﬁrst When you select a patient from the patient list a message ﬁeld is being displayed in order to activate this patient Figure ...

Страница 46: ... 32 Check if the patient s data is correct The currently active patient is always displayed in the upper left corner of the iPad screen Figure 33 If no name is displayed no patient is activated The occlusion test can now be performed NOTE The patient data is used to assign a recording to a patient and is stored together with the recorded data Only after activating a patient the handheld is ready t...

Страница 47: ...ng time which has to be previously set The data is buffered in the handheld Only after a complete recording the data is being transferred to the OccluSense iPad App Live Recording mode The live mode is started ﬁrst e g for setup Pressing the button 1 pink terminates the live mode and starts a recording just like in recording mode saves it and transmits it to the OccluSense iPad App The currently s...

Страница 48: ...ter 13 Figure 34 Active patient including the full name the birthdate a gender icon and the patient ID To be able to start a recording the handheld has to receive information about the ope ration mode and the duration of the recording Figure 35 These values can be set in the recording view and are transmitted automatically to the handheld Default values for the recording are set in the settings an...

Страница 49: ... Recording mode and duration The live mode can only be selected if the handheld is connected to the app via your local area network After choosing both values for recording mode and duration the recording can be started by pressing the left pink button of the handheld If the recording view is not currently active the app will automatically switch to this view Figure 37 Live mode icon in the record...

Страница 50: ...ion of a patient 14 4 1 Insert the sensor into the patient s mouth NOTE Slightly squeezing the cardboard frame makes it easier to insert the sensor into the patient s mouth The printed red triangle on the sensor marks the centerline Only touch the sensor on the cardboard frame CAUTION Do not insert the sensor too deep into the mouth Do not bend the sensor 48 ...

Страница 51: ...pressing button 1 pink The handheld indicates the start and end of the recording through an acoustic signal Stopping the recording depends on the selected mode Live mode In live mode the start end is not being indicated by an acoustic signal The recording is ended by pressing button 1 pink Recording Mode Combined Mode The recording ends automatically after the speciﬁed recording time has elapsed N...

Страница 52: ...iPad App Remove the sensor from the handheld and dispose of it properly after the desired recordings have been made Perform the cleaning and disinfection procedure as described in chapter 20 NOTE Occlusal contact points are also marked on the occlusal surfaces of the patient s teeth CAUTION The OccluSense Sensors are medical devices for single use and must be disposed of immediately after use chap...

Страница 53: ...pretation is shown in realtime Live recordings are not being saved However it is possible to save individual snapshots by pressing button 2 green Recording mode combined mode After recording the raw data is being stored in the patient s ﬁle of the OccluSense iPad App and displayed automatically after the recording has been ﬁnished 51 ...

Страница 54: ...o dimensionally three dimensionally or in a com bined view The following chapters describe how it is possible to record data using this menu item and which features are available for data analysis and processing Figure 38 Recording view of the app NOTE The color distribution and bar height of the images are always individually de pendent on the patient s teeth shape and occlusal behavior Therefore...

Страница 55: ...l pressure the higher the bar the higher the pressure of the occlusal contact When calculating the masticatory pressure distribution the ratio of individual contact points with the surrounding areas as well as with all contact points of the entire dental arch is taken into consideration This includes the number of contact points as well as the bite force The bars show a color gradient from green t...

Страница 56: ...s a small re lative difference between the adjacent contacts The color gradient will turn from yellow to red if the difference between the adjacent contacts will become higher In addition to the markings on the occlusal surfaces like with conventional occlusion test materials OccluSense is able to record the temporal sequence of intercuspidation During this dynamic process the pressure points and ...

Страница 57: ...mbined 2D 3D view 15 2 Resizing turning and tilting the view The three dimensional view can be resized by a pinch gesture with two ﬁngers The view can also be rotated by swiping horizontally across the diagram and tilted by swiping vertically across the diagram The position and direction of the two dimensional view can not be changed 55 ...

Страница 58: ... playing Left and right of these buttons are two double headed arrows which are pointing to the left or right These buttons move the recording back or forward by one frame to let you ﬁnd the exact moment of the recording that is relevant for you Above the described buttons you will see a blue line with a white point This line sym bolizes the total length of the recording while the point shows wher...

Страница 59: ...er than a speciﬁed threshold The threshold can be adjusted by moving the white point along the line The upper end of the line represents the threshold 0 and the bottom end represents the maximum thres hold of 255 which is equal to the maximum height of a bar Between those values the threshold is variable Figure 44 Figure 44 Slider to adjust the threshold 57 ...

Страница 60: ...the section Recordings It is also possible to load and view older recordings and snapshots Tap on the Load recording button in the top left and select the recording that shall be viewed Figure 45 Figure 45 List of available recordings of the activated patient 58 ...

Страница 61: ...ent option shows twelve percentage numbers for the twelve zones of the sensor These zones are indicated by the blue lines around the sensor The Show quartered Force Distribution option shows a circle with four quarters in the background of the sensor diagram Figure 46 The color of each quarter is a gradient ranging from green to yellow to red and shows the difference of the pressure between the qu...

Страница 62: ...can be used to ﬁnd a recording by the name Notes By using this button you can add a note to a recording or edit an existing one At the top of the note view are two buttons the trash bin to delete the open note the button to save and close the note The note is attached to the recording and is also shown within the patient management below the recording The length of the note is not limited Figure 4...

Страница 63: ...mize the diagram view and all controls not necessary to interact with the diagram are hidden The fullscreen view also permits the export of recordings as pictures PDF or video chapter 16 To leave the full screen view tap on the button again Figure 48 Figure 48 Fullscreen view of a recording 61 ...

Страница 64: ...if existent is displayed below the recording entry and adapted to the ﬁrst two lines if the text is too long To see the note in full length tap on the more button and the full text will appear Figure 49 Recordings of a patient If you want to delete a recording swipe to the left to open the submenu NOTE DELETE and tap on DELETE The menu item NOTE enables editing of the note chapter 15 7 To start a ...

Страница 65: ...e left 16 2 Compare recordings The Compare Recordings button in the playback view allows the user to compare two recordings for the selected patient Both recordings are displayed next to each other Figure 50 To change the recording to be compared use the Load Recording button at the top right of each segment The comparison view does not offer the functionality of occlusal force distribution chap t...

Страница 66: ...e format Figure 51 PDF A preview including the respective notes opens and subsequently can be exported or printed PNG The export will take a screenshot of the current scene and save it in the Photos App on the iPad Additionally the images or PDFs are being copied to a shared folder of the app acces sible via iTunes on your PC or Mac chapter 16 5 Figure 51 Exporting a screenshot is possible as eith...

Страница 67: ...to start the playback and interact with the recording in the way you want it to be seen in the video When ﬁnished tap on the grey Stop symbol Now a preview of the recorded video will be shown Figure 52 The video can be trimmed via the controls at the bottom After trimming the video this has to be conﬁrmed by tapping the Done Button at the top right corner Then use the Save button in the same posit...

Страница 68: ...he top of the patient list Now you can select any number of patients As soon as all patients are selected tap on Export at the bottom of the list In the context menu select iTunes and the export will be con ﬁrmed Exported recordings are saved as raw binary data You can access and copy the exported data via iTunes to any PC or Mac by navigating to the speciﬁc application folder Figure 53 This is ne...

Страница 69: ... go to the patient management screen Tap the Edit but ton on top of the patients list and use the Import button to start the import process Figure 54 Figure 54 Import button If the data has been sent via AirDrop to an iPad the OccluSense iPad App will launch automatically You will be asked if the received ﬁle should be saved for immediate or later import If you decide to import the data later the ...

Страница 70: ...ly This might take a few minutes During the update process the connection to the handheld will be lost and the WLAN data might be lost as well To reconnect the handheld device refer to chapter 10 2 17 3 Terms and conditions The terms and conditions of the app are listed here You will be asked to accept these terms and conditions to register your handheld device which is needed to use all functio n...

Страница 71: ...out the local wireless network indicated by the missing name of the local wireless network at the handheld device connection indicator switch the iPad s wireless network to the network of the OccluSense handheld device Then reconnect the handheld device to the local wireless network for details refer to chapter 10 2 If the handheld device does not reconnect automatically to the app when using the ...

Страница 72: ...erating instructions Hardware Requirements Update the iOS Try to download the App again Check internet access The connection between Occlu Sense iPad App and handheld is not possible Another handheld is already connected to the app The WLAN connection between iPad and handheld is insufﬁcient or not available The rechargeable batteries of the iPad or the handheld are not properly charged Disconnect...

Страница 73: ...lures consult Bausch support occlusense com Ensure connection to the Apple AppStore Perform update chapter 17 2 21 3 OccluSense Handheld Error symptom Cause Action Handheld can not be switched on There are no batteries in the battery compartment The batteries have been inserted incorrectly The batteries are insufﬁciently charged Insert batteries into the battery compartment chapter 8 1 Remove the ...

Страница 74: ...uested function test with the test sensor has not been performed or it has failed Perform registration process see chapter 10 2 4 Perform or repeat function test with test sensor chapter 12 Consult Bausch support occlusense com OccluSense Charging station Error symptom Cause Action The charging station cannot be connected to the local power supply The matching power supply plug is defective or mis...

Страница 75: ...eces sary reposition the sensor chapter 14 1 2 Replace unrecognized Occlu Sense Sensor Consult Bausch support occlusense com Treatment Error symptom Cause Action The handheld turns off after a few recordings There are no suitable recharge able batteries inserted in the battery compartment The batteries are defective see manual chapter 8 1 Replace batteries use of 3 x AAA NiMH recharge able batteri...

Страница 76: ...dity 20 90 Atmospheric pressure 500hPa 1060hPa 20 1 Handheld Clean and disinfect the handheld within max 2 hours after treatment 1 Switch off the handheld To do this press and hold button 1 pink for more than 2 seconds Alternatively the handheld switches itself off automatically after appro ximately 4 minutes 2 Remove the sensor from the device and dispose it in accordance with ofﬁcial disposal re...

Страница 77: ...n case of disregard any liability is excluded NOTE The instructions of the manufacturer of the detergent and disinfectant must be followed strictly In particular the concentrations to be used and the ap plication times must be observed CAUTION The components of the OccluSense System are not suitable for mechanical cleaning and thermal disinfection processes The battery compartment cover must be cl...

Страница 78: ...e function test of the device then there is probably a defect in the Occlu Sense System In this case see chapter 19 21 2 Replacing the batteries CAUTION Do not make any repairs or other changes to the system The use of damaged and altered components is under the responsibility of the user In case of disregard any liability is excluded 1 Loosen the screws of the battery compartment cover using a To...

Страница 79: ...iMh rechargeable batteries with a capacity of at least 1000mAh each in the correct arrangement see markings in the battery compartment 4 Insert the battery compartment cover and tighten the screws by hand CAUTION Batteries inserted inversely can reach high temperatures and damage the device Pay attention to the marking in the battery compartment 77 ...

Страница 80: ...orts updating the handheld ﬁrmware and the OccluSense iPad App As soon as an update of the handheld ﬁrmware or the OccluSense iPad App is available a reminder for the update is automatically displayed and can be downloaded and installed by selecting Settings Handheld Firmware 78 ...

Страница 81: ... in detail Rechargeable Batteries EU Directive 2006 66 EC Law on the placing on the market ta king back and environmentally friendly disposal of batteries and accumulators Battery Act BattG Handheld equipment without batteries charging station and test sensor EU Directive 2012 19 EU on waste electrical and electronic equipment WEEE Act on the marketing take back and environmentally sound disposal ...

Страница 82: ...ir attempts will void the warranty Otherwise the General Terms and Conditions of Dr Jean Bausch GmbH Co KG apply 27 Customer Service Please use our support system and our knowledge database under the menu item Help You can contact our support team via the request form An internet connection is required Alternatively you can reach our support system at help occlusense com Phone support Germany Euro...

Страница 83: ...mbH Co KG info occlusense com and the respective authority of the EU member state NOTE The OccluSense System is an intensively tested product Nevertheless a mal function may result in the incorrect display of the masticatory forces The de cision of therapeutic treatments must not be based solely on the data recorded by the OccluSense System For this purpose further information must be ob tained in...

Страница 84: ...dure according to Annex VII of the directive 93 42 ECC MDD Dr Jean Bausch GmbH Co KG hereby declares that the products mentioned above meet the require ments of the Directive 93 42 ECC MDD and the Directive 2007 47 EC for medical devices as well as the Directive 2014 53 EU for radio equipment The technical documentation which meets the requirements for verification of compliance of the above men t...

Страница 85: ...nstallation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a ci...

Страница 86: ...y Ltd ABN 73093760402 G P O Box 3733 Sydney NSW 2001 Australia Tel 61 2 9345 1945 Fax 61 2 9345 1955 E Mail info bauschdental com au Internet www bauschdental com au Bausch Articulating Papers Japan K K 2nd Floor 1 4 2 Jonan Ikedashi Osaka 563 0025 Japan Tel 81 72 737 9501 Fax 81 72 737 9502 E Mail info bauschdental jp Internet www bauschdental jp Bausch Importacão de Materiais Odontológicos Ltda ...

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