jazz solo user manual - jazz imaging solo user manual rev d.pdfjazz solo sensor is a suitable...

JAZZ SOLO Dental Imaging Sensor User Manual

JAZZ Imaging 800 Charcot Ave Suite 100 SAN JOSE, CA 95131 USA

Phone: (567) 234-5299

Jazz Solo User Manual (MAN-001, Rev D) 1

1 GETTING STARTED ................................................................................................................................. 4

1.1 WELCOME TO JAZZ IMAGING ....................................................................................................... 4

1.2 PURPOSE ....................................................................................................................................... 4

2 USE ........................................................................................................................................................ 5

2.1 INDICATIONS FOR USE .................................................................................................................. 5

2.2 INTENDED USE .............................................................................................................................. 5

2.3 PEDIATRIC USE OF JAZZ SOLO SENSOR ............................................................................................ 6

2.3.1 STEPS TO AVOIDING ACCESS PEDIATRIC IMAGE ACQUISITION .................................................... 6

2.3.2 FEATURES AND BENEFITS FOR PEDIATRIC USE OF JAZZ SENSOR .................................................. 6

2.3.3 RELATIVE X-RAY DOSE INDICES FOR PEDIATRIC USE OF JAZZ SENSOR ......................................... 7

2.3.4 LITERATURE REFERENCES FOR PEDIATRIC IMAGING ................................................................... 7

2.4 SYSTEM DESCRIPTION ................................................................................................................... 8

3 INSTALLATION / ACTIVATION ................................................................................................................ 8

3.1 WHAT YOU WILL NEED TO COMPLETE THIS SECTION .................................................................. 8

3.2 PC (SERVER / WORKSTATION) REQUIREMENTS ............................................................................ 9

3.2.1 WORKSTATION (Client or Standalone) .................................................................................. 9

3.2.2 SERVER .................................................................................................................................. 9

3.3 BEFORE YOU INSTALL ANY SOFTWARE ....................................................................................... 10

3.4 BEFORE YOU PLUG THE JAZZ SOLO SENSOR INTO A COMPUTER ............................................... 10

3.5 TWO STEP INSTALLATION OF THE JAZZ IMAGING SYSTEM ........................................................ 10

3.6 INSTALLING THE JAZZ CONTROL CENTER (STEP 1) ...................................................................... 11

3.6.1 JAZZ IMAGING Sensor Activation (in Control Center) ......................................................... 19

3.6.2 JAZZ IMAGING DOSE OPTIMIZATION .................................................................................. 24

3.6.3 JAZZ IMAGING CUSTOMER SERVICE (in Control Center) .................................................... 31

3.6.3.1 ONLINE SUPPORT ............................................................................................................ 31

3.6.3.2 CHAT SUPPORT SESSIONONLINE..................................................................................... 33

3.6.4 JAZZ IMAGING NOTIFICATION WIZARD (in Control Center .................................................... 35

3.6.5 JAZZ TEST IMAGE ACQUISITION (in Control Center) ........................................................... 36

3.7 INSTALLATION AND INTEGRATION OF IMAGING SOFTWARE (STEP 2)....................................... 37

3.7.1 INSTALLATION OF JAZZ SENSOR WITH JAZZ HARMONY SOFTWARE .................................. 37

3.7.2 INSTALLATION OF JAZZ SENSOR WITH THIRD PARTY IMAGING AND PRACTICE

MANAGEMENT SOFTWARE ................................................................................................................ 37


3.7.2.1 FUSION WITH EXISTING DEXIS DENTAL IMAGING SOFTWARE ........................................... 38

(Provided by JAZZ IMAGING) ............................................................................................................ 38

3.7.2.2 FUSION WITH EXISTING GENDEX / GxPicture / VixWin DENTAL IMAGING SOFTWARE....... 40


3.7.2.3 JAZZ HARMONY AUTOBRIDGE FOR PRACTICE MANAGEMENT SOFTWARE ........................ 41


3.7.2.4 NATIVE BRIDGING (Provided by Practice Management Provider) ...................................... 42

3.8 INSTALLING THE JAZZ IMAGING WALL MOUNT.......................................................................... 42

3.8.1 Wall-Mounting Option (with Adhesive) .............................................................................. 43

3.8.2 Wall-Mounting Option (with Fasteners) ............................................................................. 43

3.9 Storing the Sensor and USB Cable on the Wall Mount ............................................................... 44

4 OPERATION ......................................................................................................................................... 45

4.1 PRECAUTIONS DURING X-RAY OPERATION ................................................................................ 45

4.2 CONNECTING YOUR JAZZ SOLO SENSOR TO THE USB-PORT ...................................................... 45

4.3 THE JAZZ IMAGING EASY POSITIONING SYSTEM ........................................................................ 45

4.3.1 POSITIONERS DELIVERED WITH THE JAZZ IMAGING EASY POSITIONING SYSTEM ............. 46

4.3.2 ASSEMBLING THE JAZZ IMAGING SYSTEM EASY POSITIONING SYSTEM ............................ 49

4.3.3 APPLYING THE PARALLELING TECHNIQUE WITH THE JAZZ IMAGING EASY POSITIONING

SYSTEM 49

4.3.3.1 MAXILLARY ANTERIOR POSITIONING .............................................................................. 50

4.3.3.2 MAXILLARY POSTERIOR POSITIONING ............................................................................ 51

4.3.3.3 MANDIBULAR ANTERIOR POSITIONING .......................................................................... 52

4.3.3.4 MANDIBULAR POSTERIOR POSITIONING ........................................................................ 53

4.3.3.5 BITEWING POSITIONING (HORIZONTAL / VERTICAL) ...................................................... 54

4.4 USE OF PROTECTIVE SHEATHS .................................................................................................... 54

5 HYGIENE / CARE / MAINTENANCE ...................................................................................................... 55

5.1 HANDLING ................................................................................................................................... 55

5.1.1 PROTECTING YOUR SENSOR FROM POTENTIAL DAMAGE ......................................................... 55

5.1.2 AVOIDING DAMAGE TO THE JAZZ SOLO SENSOR CABLE .................................................... 55

5.2 CLEANING / DISINFECTION ......................................................................................................... 56

5.2.1 CLEANING THE JAZZ IMAGING SENSOR .................................................................................. 57

5.2.2 STERILIZATION OF JAZZ IMAGING EASY POSITIONING - SYSTEM (HOLDERS & RINGS) .......... 58


5.3 MAINTENANCE ............................................................................................................................ 59

5.3.1 PERIODIC MAINTENANCE........................................................................................................ 59

6 WARRANTY / PARTS / SUPPORT ......................................................................................................... 60

6.1 WARRANTY.................................................................................................................................. 60

6.2 DAMAGED SENSOR ..................................................................................................................... 60

6.3 JAZZ SENSOR REPLACEMENT ...................................................................................................... 60

6.4 PART NUMBERS (SENSOR / JAZZ IMAGING EASY POSITIONING - KIT /ACCESSORIES) ............... 61

6.5 WEB-SUPPORT / CUSTOMER-SERVICE HOTLINE ......................................................................... 62

6.6 FREQUENTLY ASKED QUESTIONS (FAQ) ...................................................................................... 63

7 SAFETY, SPECIFICATIONS AND STANDARDS ........................................................................................ 64

7.1 SAFETY ......................................................................................................................................... 64

7.1.1 SYSTEM INSTALLATION AND OPERATION VERIFICATION ................................................... 64

7.1.2 AUTHORIZED DESIGNEES PERMITTED TO OPERATE THE SYSTEM ...................................... 64

7.1.3 USE OF PARTS THAT WERE NOT DELIVERED WITH THE JAZZ IMAGING SYSTEM ............... 64

7.1.4 AVOIDING UNAPPROPTIATE ACTIVATION OF THE X-RAY SOURCE ..................................... 65

7.1.5 RISK OF RECIPROCAL INTERFERENCE DURING SPECIFIC ..................................................... 65

INVESTIGATIONS OR TREATMENTS..................................................................................................... 65

7.1.6 CORRECT DISPOSAL OF JAZZ SOLO SENSOR ........................................................................ 65

7.2 SPECIFICATIONS AND STANDARDS ............................................................................................. 66

7.2.1 LEAKAGE CURRENT STATEMENT ............................................................................................. 67

7.2.2 EMC TABLES ............................................................................................................................ 67

7.2.2.1 DECLARATION- ELECTROMAGNETIC EMISSIONS ............................................................ 67

7.2.2.2 DECLARATION- ELECTROMAGNETIC IMMUNITY ............................................................ 68

7.2.2.3 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT AND THE JAZZ IMAGING SENSOR ............................................. 70

7.3 SYMBOLS ..................................................................................................................................... 71


1 GETTING STARTED

1.1 WELCOME TO JAZZ IMAGING

Welcome to JAZZ IMAGING! First of all, THANK YOU for your investment in the JAZZ Imaging System. We have been and continue to be focused on delivering you the best intraoral sensor and support in the market and hope you will have an outstanding experience with our products and services.

At JAZZ IMAGING, our Sensors are designed, developed and manufactured in the U.S. by engineers with over 20 years of experience in the production of digital dental X-Ray sensors. With our experience and the feedback received by our JAZZ IMAGING reference sites, our goal was and is to develop an affordable and easy to use low dose intraoral x-ray system with the highest image quality available.

Your JAZZ IMAGING System comes with a unique positioning system where all unnecessary single parts have been eliminated making it simple to use and further enhance image quality and the user experience.

Like everything new, we know there will be a short but steep learning curve before being proficient. That’s why our support team will be available during normal office hours, at no extra cost, to give you any support you might possibly need with your new JAZZ IMAGING System.

Thanks again and welcome to the JAZZ IMAGING family.

1.2 PURPOSE

The JAZZ IMAGING Digital X-Ray System combines superior sensor design and usability, supported by the JAZZ SOFT Imaging Software, providing a high-end platform featuring:

High resolution image acquisition of 20+ lp/mm. System integrated calibration files. Hassle free sensor replacement in the case of defect

(excluding inappropriate use or lack of maintenance of the JAZZ Imaging System).


2 USE

2.1 INDICATIONS FOR USE

The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

2.2 INTENDED USE

The JAZZ SOLO Sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The JAZZ SOLO Sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The JAZZ SOLO Sensor can be used either in combination with the provided JAZZ IMAGING positioners, other universal positioning devices manufactured to facilitate the positioning and alignment with an x-ray beam, or it may also be positioned by hand with the assistance of the patient. The JAZZ SOLO Sensor can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized.

The Jazz Solo dental sensor requires a dedicated imaging software package to operate at full potential as a diagnostic imaging device. The imaging software is not included and may need to be purchased separately.

JAZZ SOLO Sensor is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Furthermore, available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis.

When using the JAZZ SOLO Sensor and software as a diagnostic aide, clinical experience and a combination of other diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.


2.3 PEDIATRIC USE OF JAZZ SOLO SENSOR

Although generally most newer digital X-Ray Sensor technology is considered “low dose”, due to the more frequent acquisition of intraoral images of children, it remains especially important to access the need and frequency that x-ray procedures are acquired. The operator should always apply the ALARA concept (maintaining dose As Low As Reasonably Achievable) when acquiring all images, especially those of children.

2.3.1 STEPS TO AVOIDING ACCESS PEDIATRIC IMAGE ACQUISITION

Practitioners should always determine if new or additional X-Rays are needed to answer a clinical question, before subjecting child patients to ionized radiation.

Patient image history should be verified to avoid duplicate exams

Consider alternate procedures that use less of no radiation exposure.

In the case of referral patients, check with referrer for already existing images to avoid performing duplicate exams

The JAZZ SOLO Sensor was especially ergonomically designed for easier positioning and as a low dose Sensor:

2.3.2 FEATURES AND BENEFITS FOR PEDIATRIC USE OF JAZZ SENSOR

Design Characteristics / Software Tools:

JAZZ Solo Sensor with eliminated corner design 45 degree Sensor cable angulation on rear of Sensor housing Proprietary easy to use sensor holders

Sensitive low dose sensor Dose Optimization tool

Benefits for pediatric use:

Easier positioning in smaller child patient mouth Reduction of image retakes due to incorrect positioning Verification (by use of the Dose Optimization Tool) that

minimal dose settings are always used when acquiring images, resulting in less ionized radiation being acquired by patients and ensuring adherence to the ALARA concept.


2.3.3 RELATIVE X-RAY DOSE INDICES FOR PEDIATRIC USE OF JAZZ SENSOR

Below an example of the recommended x-ray timer settings (in seconds) for acquisition of child images using a 70kV generator.

NOTE: These timer settings are different for each generator. Please perform a Dose Optimization for each x-ray generator in your practice. Detailed information on how to perform the Dose Optimization can be found in later in this manual.

Anterior: 0.024 – 0.035s / Premolar: 0.029 – 0.041s

2.3.4 LITERATURE REFERENCES FOR PEDIATRIC IMAGING

More guidance specific to pediatric imaging can be found here:

Image Gently Website: http://www.imagegently.org/

FDA Pediatric X-Ray Imaging Webpage: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm

http://www.imagegently.org/

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm




2.4 SYSTEM DESCRIPTION

The JAZZ SOLO Sensor connects to the USB Interface of a compatible PC. The workstation runs a compatible Windows operating system and also provides the power source for the device.

Support for the JAZZ SOLO Sensor is provided by JAZZ Imaging (www.jazzimaging.com/support). Or calling (567) 234 5299 ext. 300

The JAZZ SOLO Sensor includes a wall mount so the device can be stored either by screwing the mount to a wall or other stable surface.

3 INSTALLATION / ACTIVATION

IMPORTANT: Installers must ensure that the Jazz Imaging System provided to the user is installed correctly to ensure the optimal use of the equipment. This includes, but is not limited to, ensuring that the system operates as described in this document. Installers must ensure that the system presents no physical obstacles or hazards during operation and when not in use. To verify this requirement, installers shall confirm that the JAZZ IMAGING Sensor is installed as described

in this User Guide and shall perform the appropriate procedures therein.

3.1 WHAT YOU WILL NEED TO COMPLETE THIS SECTION

To expedite software installation, please have all the following items available. All the necessary software can be found on the provided JAZZ IMAGING USB St -KEY- that you received in the same box as your JAZZ Imaging Sensor.

Windows PC and or Server with at least one free USB Port and internet access (if available).

JAZZ CONTROL CENTER Software (USB Stick). JAZZ SOFT Dental Imaging Software (USB Stick). JAZZ SOLO Sensor. Between 30 mins and one hour of your time (can by

considerably less time needed depending on the number of PCs and type of installation being performed).

http://jazzimaging.com/support


3.2 PC (SERVER / WORKSTATION) REQUIREMENTS

The PC workstation connects to the Jazz Imaging Sensor via a USB Port and serves as the host for imaging software products. The workstation provides the capability to display, manipulate, store, and print images acquired by the JAZZ Solo Sensor.

Getting the best results from your Jazz Imaging System begins with having a computer system suitable for capturing and displaying intraoral images. For optimum performance, we recommend the following:

3.2.1 WORKSTATION (Client or Standalone)

Windows 10 x32, Windows 10 x64, Windows 8.1 x32, Window 8.1 x64, Windows 7 x32 and Windows 7 x64

(min. Service Pack 1 must be installed) The JAZZ Solo Sensor does not operate on operating systems prior to Windows 7)

Intel i7 or equivalent. 4 GB RAM. 256 MB graphics card. Min. 500 GB hard drive (practice-specific, depends on number of patients). Intel USB 2.0 or 3.0. Port.

3.2.2 SERVER

Windows Server 2003 R2 (SP1 minimum) and Windows Server 2008 R2.

TCP/IP networking protocols (for DICOM Servers). 4 GB RAM (recommended). 1 TB (recommended).

NOTE: To achieve maximum image transfer-to-display time, we recommend quad-core processors, 8 GB RAM, min. Windows 7 operating system with SP1, and 512 MB graphics card. Recommended minimum display resolution is 1280x1024.


3.3 BEFORE YOU INSTALL ANY SOFTWARE

Before installing any of the software delivered with your JAZZ IMAGING System, exit any software/programs open on your computer and perform a complete backup of your dental administrative and dental imaging software before you proceed. Please also read the complete section dedicated to the installation of the JAZZ Imaging System and components BEFORE proceeding.

3.4 BEFORE YOU PLUG THE JAZZ SOLO SENSOR INTO A COMPUTER

IMPORTANT: Please do not connect the Jazz Imaging Sensor into any of your computers until after you have installed the JAZZ CONTROL CENTER (provided on JAZZ IMAGING USB KEY- that you received in the same box as your JAZZ Imaging Sensor).

3.5 TWO STEP INSTALLATION OF THE JAZZ IMAGING SYSTEM

IMPORTANT: There are two separate steps needed to complete the full installation of your JAZZ IMAGING System.

STEP 1: The very first mandatory step that will need to be performed by all JAZZ IMAGING Sensor users, regardless of the dental imaging software intended to be used, is the installation of the JAZZ CONTOL CENTER followed by a minimum of two steps.

Activation of your Jazz Imaging Sensor(s). X-Ray dose optimization of your X-Ray generator(s).

STEP 2: The second step that will need to be performed is dependent upon which Dental Imaging Software you would like to use your JAZZ IMAGING Sensor and how you would like to integrate to that software.


3.6 INSTALLING THE JAZZ CONTROL CENTER (STEP 1)

The JAZZ CONTOL CENTER (JCC) is an integral part of your new JAZZ IMAGING System. This application will allow you to perform many different tasks, including but not limited to, the following:

Activation of your Jazz Imaging Sensor(s). X-Ray dose optimization of your X-Ray generator(s). Check or change the JAZZ IMAGING Sensor Imaging

parameters. Control how frequently you receive system information

regarding the status and licensing of your JAZZ IMAGING System.

Perform software and driver updates manually or automatically.

Initiate /Request Support from JAZZ IMAGING Tech Support. Take a test image with your JAZZ IMAGING SENSOR. Renew or check status of users JAZZ CLUB MEMBERSHIP. Connect to the JAZZ IMAGING Web Shop.

Please follow the following steps to install the JAZZ CONTROL CENTER on your computer.

1. Insert the JAZZ IMAGING USB KEY- into the USB port of the computer.

2. If the JAZZ Autostart Menu screen is not automatically

shown, open the windows file explorer manually and click on the Drive associated with the JAZZ IMAGING USB KEY (usually “D:) and Click on the file “JazzAutoStart.exe.”

NOTE: To close the JAZZ Autostart Menu screen click on the “Close” button.


NOTE: To close the JAZZ Autostart Menu screen click on the “Close” button.

3. Start the JAZZ CONTROL CENTER Installation by clicking on the “JAZZ Control Center Installation (Required)” button on the Jazz AutoStart Menu screen.

NOTE: If you have an active internet connection and a newer version is available, the following message will be displayed below will show on the screen. If the message does not appear, please skip to Step 6 to continue with the installation from the JAZZ USB KEY.

4. Click on “Yes” to download the latest version of the Jazz Control


Center download will start.

5. Depending on your internet speed this may take up to 5

minutes. When the download is complete the installation will

start automatically.

6. Click on “Next” to start the installation of the Jazz Control

Center.

NOTE:

We recommend the Installation in the standard folder

7. To install the Jazz Control Center into the standard


installation folder, click “Next” and continue with Step. 12. To choose a different installation folder follow the steps below:

8. Click on the red cross next “Control Tool.”

9. Check the box next to “will be installed on local hard drive and click “Browse” to choose the local drive where you would like to perform the installation.


10. Select the folder in the “Location” screen and click on “Select Folder” to confirm the location.

11. Click “Next” to continue.

12. Check the box to accept the License Agreement and click “Next” to continue.


13. Click “Install” to begin the software installation. NOTE: If the screen shown above is displayed on your screen, additional Microsoft software must be installed. If the screen shown above is not shown continue with Step 11.

14. Check the box to accept the license terms and click “Install” to continue


15. Click on “Close” to confirm the successful setup.

16. Check the box to accept the license terms and click “Install” to continue.

17. Click on “Close” to confirm the successful setup


18. Check the “Always trust software from Jazz Imaging LLC and click “Install” to continue.

19. If you are installing the JAZZ Control Center on this PC for the first time, please plug in the JAZZ Solo Sensor now. Wait for the Sensor device driver to be installed.

20. Click on “Finish” to complete the installation.

You will be able to start the JAZZ Control Center by clicking on the small icon on the bottom right of the task bar Or the “Jazz Control Center” icon on the desktop.


3.6.1 JAZZ IMAGING Sensor Activation (in Control Center)

IMPORTANT! If you do not have a working internet connection and a valid JAZZ IMAGING CLUB membership, the activation process will have to be performed by manually entry of an activation code. Your latest activation code will be sent to the inbox of the email-address linked to your JAZZ CLUB Membership. Contact JAZZ Customer Service if you do not have your activation code on site to receive your activation code.

1. Ensure that the JAZZ CONTROL CENTER is already installed on your PC. If already installed, a small icon will be visible at the bottom right of the task bar.

Alternatively, you also start the JAZZ Control Center by clicking on the “Jazz Control Center” icon on the desktop.

The JAZZ Control Center will open the Home Screen will be displayed:

2. Connect the sensor that you would like to activate to

your PC. The connected JAZZ Solo Sensor and the current status will be shown on the Control Center home screen.


3. If you do not have an active internet connection skip to Step 7, otherwise follow the steps below.

4. Click on the “Check Licenses” button

5. Click “Yes” to confirm that you would like to update the licenses for all the connected sensors.


6. Click “OK” to finish the update process. Congratulations! You have successfully automatically activated / updated your JAZZ Solo Sensor license.

The updated Sensor License Status will be shown.

7. To manually update the Sensor license, look in your Email for your activation license or contact JAZZ Imaging Support via the Control Center, website http://jazzimaging.com/support or by dialing (567) 234 5299 ext. 300. before continuing with the following steps:

8. Connect the sensor to the PC.

9. In the list, choose the sensor you would like to update by right clicking the right mouse button in the corresponding line.

Right click anywhere in the line

http://jazzimaging.com/support


Choose “Update X-Ray Sensor License” followed by “Update License from File.”

10. Click “Yes” to confirm that you would like to update the licenses for the selected sensor.


11. Choose the Folder containing the Sensor update file and click on “OK” to update the license.

12. Click “OK” to finish the update process.

Congratulations! You have successfully manually activated / updated your JAZZ Solo Sensor license.

You will be able to start the JAZZ Control Center by clicking on the small icon on the bottom right of the task bar

and “Jazz Control Center” icon that will be visible on the desktop.


3.6.2 JAZZ IMAGING DOSE OPTIMIZATION

IMPORTANT! To ensure that correct X-Ray generator timer settings are defined during the initial setup of the JAZZ IMAGING Solo Sensor, we provide a dose optimization wizard. This dose optimization tool should be used to for each specific X-Ray generator in the dental office. This DOSE OPTIMIZATION wizard enables the user to easily determine the correct generator settings for image acquisition of standard tooth areas (Anterior, Premolar, Molar) without unnecessarily exposing a patient to ionized radiation. Performing this optimization procedure before taking the first real patient images, can help avoid the common error, of exposing patients to more ionized radiation than necessary. This can help avoid unnecessary image retakes and avoid subjecting patients to excess ionized radiation. The JAZZ IMAGING SYSTEM requires less X-Ray dose than film and comparable X-Ray imagers, benefiting the patient and reducing risk to operators.


1. If not already installed, please install the Jazz Control Center by following the necessary steps, as described earlier in this User Manual

2. Connect an activated JAZZ IMAGING Sensor to your PC.

3. Start the JAZZ CONTROL CENTER“ by clicking on the JAZZ icon in the task bar at the bottom right of your screen

The Jazz Control Center Home screen will be displayed as show below:

When JAZZ IMAGING Sensors are connected, the sensor information will be displayed on the top part of the screen. On the bottom part of the screen, the optimal X-Ray settings for the generator you are using in the current operatory will be shown on the bottom part of the screen after the dose optimization process has been performed. The “Adult” and “Child” buttons will display the optimal X-Ray timer settings for exposure of adults or children. NOTE: Until the dose optimization process has been performed, the values show on the bottom of the screen will show in grey.


1. On the JAZZ CONTROL CENTER home screen, choose “Dose

Optimization Wizard” from the top menu bar.

Proceed with the following steps to mount the X-Ray mount onto your X-Ray tube and then acquire images with your X-Ray generator to determine the optimal X-Ray timer setting for patient images. View the images and follow the instructions shown on the center of the screen. When you have performed the instructions shown on the screen, proceed to the next step with the button “Next step”. If needed, go back to the previous step by clicking on the “Previous Step” button.

NOTE: Until the dose optimization process has been performed, the field “Exposure Time Used” will not be accessible and inactive.

2. Open the Velcro band and slip the loop over the X-Ray generator tube end, ensuring that the plastic part is on the bottom of the tube head.

3. Ensure that the X-Ray mount is as close to the end of the X-

Ray tube head as possible

4. Mount the X-Ray mount onto the X-Ray generator tube head as shown in the image above.


5. Check that the X-Ray mount fits tightly onto the X-Ray

generator tube

6. Press ‘’Next step” to continue.

7. Turn the X-Ray tube head so that it is parallel to the floor

8. Push the blue JAZZ IMAGING Anterior Holder as far as possible into the X-Ray mount.


10. Slide the JAZZ IMAGING sensor into the holder and check that the holder and sensor are within the inner circle (or rectangle) of the X-Ray tube


12. Connect the JAZZ Solo Sensor to your PC.



14. Determine the current kV settings of your generator. Some X-Ray generators have one single fixed setting, others have the option of switching between two settings (e.g. 60kV – 70kV) If you are unsure about the kV setting of your X-Ray generator, please refer to you X-Ray generator user manual.

15. Set the X-Ray generator timer settings to: between 0.080s.(80ms) to 0.100s (100ms) for a 60 kV or between 0.060s.(60ms) to 0.080s (80ms) for a 65 kV or between 0.040s.(40ms) to 0.050s (50ms) for a 70 kV X-Ray generator. .

16. Press ‘’Next step” to continue

Press the START button and follow the instructions at the bottom of the next screen

You will see the remaining time left to expose the sensor to X-Rays counting down from 60s on the bottom of the screen.

17. Trigger the X-Ray generator timer before the countdown reaches 0s and continue.


NOTE: If no image is taken before the countdown ends, the following message shown below will be displayed on the screen:

If you see the above message, first click on “OK” and then on the “START” button again to repeat steps 14 to 17. If you activated the X-Ray generator before the countdown ended, the acquired dose shall be show as a green bar and prompt one of the following three screens. Follow the steps shown on the screen and perform the instructions, lowering or increasing the X-Ray generator time accordingly, until the green bar reaches the “usable range”.

18. The X-Ray Dose is too low for dose optimization. Please increase the generator time/dose and click the “START” button.

19. The X-Ray Dose is too high for dose optimization. Please decrease the generator time / dose and click “START” button.


The X-Ray Dose is usable for dose optimization. The fields “Exposure time used” and “kV” are now enabled and can be edited.

20. Please enter the timer settings used when a usable range

was reached, either manually or by clicking the up or down buttons.

21. Please check the box that matches the current “kV” settings of your X-Ray generator.

22. Click on “Apply”.

You will be re-directed to the JAZZ Control Center home screen

The “Adult” and “Child” buttons will change the displayed optimal X-Ray timer settings for exposure of adults or children Switch to kV settings to match the kV settings with which you will be using your generator for patient image acquisition. If you have an X-Ray generator with adjustable kV settings, be sure to check the box with the corresponding kV value to the new kV setting. The chart values for each tooth region


will be updated to assist you setting optimal values for patient image acquisition. On the bottom section of the screen, the correct dose settings for acquisition of standard tooth areas (Anterior, Premolar, Molar) will be displayed. NOTE: These values are only approximate guidelines to help the help the practitioner find acceptable settings. The practitioner is responsible for determining that correct x-ray settings are always used during patient image acquisition. We recommend enabling Dose notifications in the Settings section of the JAZZ Control Center. This will force a notification to be displayed each time an image is acquired when the average dose is either too high or too low for optimal image quality.

3.6.3 JAZZ IMAGING CUSTOMER SERVICE (in Control Center)

3.6.3.1 ONLINE SUPPORT

1. Start the JAZZ Imaging Control Center “ by clicking the small icon on the bottom right of the task bar

or the “JAZZ Control Center” icon that will be visible on the desktop.


2. On the JAZZ Imaging Control Center Home screen, choose “Customer Support” from the top menu bar.

3. On the JAZZ Imaging Control Center Home screen, choose “Online Support” from the top menu bar.

4. Select your desired support topic from the JAZZ Imaging

Support webpage.


3.6.3.2 CHAT SUPPORT SESSION ONLINE

For your convenience, Customer Service / Technical support can be reached directly via chat from within, the JAZZ Imaging Control Center. A technician will assist you with your issue and initiate further measures as needed. Our Customer Support if also available also by calling (567) 234 5299 ext. 300 during office hours. Start the JAZZ Imaging Control Center “ by clicking on the small icon on the bottom right of the task bar


1. On the JAZZ Imaging Control Center Home screen, choose “Customer Support” from the top menu bar.

2. To contact JAZZ Customer Support click on “Start Chat Session.” This will start a Chat window within the JAZZ Control Center. If the window below does not show, click on the blue link on the upper right to start the chat request in your standard web browser.


3. Enter your First Name, Last Name and Email address.

4. Click “Chat” to connect to a JAZZ Customer Service representative

5. Submit your question into the “Type a message” field and hit the “Enter” Key to send.

A JAZZ Customer Service representative will respond shortly.


3.6.4 JAZZ IMAGING NOTIFICATION WIZARD (in Control Center

1. Start the JAZZ Imaging Control Center “ by clicking on the

small icon on the bottom right of the task bar


2. On the JAZZ Imaging Control Center home screen, choose “Settings” from the top menu bar.

3. Check or uncheck the boxes of the corresponding settings to activate or deactivate how the system handles updates and notification according to your personal preference.


3.6.5 JAZZ TEST IMAGE ACQUISITION (in Control Center)

A test image can only be acquired, within the control center, with the assistance of a member of Jazz Imaging technical support. Please contact the JAZZ Imaging technical support by either calling (567) 234 5299 ext. 300, or start a chat request as described earlier in this manual. NOTE: Please be sure to contact a JAZZ technical support representative before continuing, as only this part of the control center is only accessible by a JAZZ Imaging technician.

1. Start the JAZZ Imaging Control Center “ by clicking on the small icon on the bottom right of the task bar


2. On the JAZZ Imaging Control Center home screen, choose

“Technician settings” from the top menu bar.

The JAZZ technical support representative will enter the technician password.


3.7 INSTALLATION AND INTEGRATION OF IMAGING SOFTWARE (STEP 2)

IMPORTANT: The installation of the JAZZ Imaging Contol Center as described earlier must be performed BEFORE continuing with the installation of any software described in this section.

The integration/connection of the following existing Practice Management Software solutions to our JAZZ Harmony Imaging Software is also optionally supported, either directly by JAZZ Imaging, your Practice Management Software Manufacturer or by a third party.

The JAZZ SOLO Sensor is an open and flexible system that allows many different options and variants when it comes to installation and integration into your dental office environment. Generally, there are two possible variants of how you can perform your installation. If you are uncertain which software you need to install or how to install the necessary software, please contact JAZZ Imaging Customer Support (567) 234-5299 ext. 300 or www.jazzimaging.com/support.

3.7.1 INSTALLATION OF JAZZ SENSOR WITH JAZZ HARMONY SOFTWARE

If this is your first digital X-Ray sensor and you are not yet using a Dental Imaging Software in your dental office OR you want to perform a fresh/new installation, separate from an existing installation, you will be using your JAZZ Solo Sensor with our JAZZ Harmony Software.

Please continue with Step 2 of your JAZZ IMAGING System installation by following the instructions in the “JAZZ Harmony Software User Manual. This manual can be found on your JAZZ IMAGING USB-KEY or downloaded from our website: www.jazzimaging.com/support.

3.7.2 INSTALLATION OF JAZZ SENSOR WITH THIRD PARTY IMAGING AND PRACTICE

MANAGEMENT SOFTWARE

If this is not your first digital X-Ray sensor OR you are not planning on using your JAZZ IMAGING Sensor with the JAZZ Harmony Software, you will either directly or indirectly be acquiring your JAZZ Imaging Sensor images through a third party dental imaging software or practice management software.

http://www.jazzimaging.com/support

http://www.jazzimaging.com/support


We currently support the following Dental Imaging Software with FUSION:

Dexis 9 Dexis 10 Dexis 11 Gendex / VixWin Platinum

We currently support the following Practice Management Software with AUTOBRIDGE from within JAZZ Harmony:

PracticeWorks (Carestream) Softdent (Carestream)

Easy Dental (Henry Schien) Eaglesoft (Patterson)

IMPORTANT! The full quality of images physically acquired by the JAZZ IMAGING Sensor may not be visible in the third party software.

Please choose your desired installation type out of the following:

3.7.2.1 FUSION WITH EXISTING DEXIS DENTAL IMAGING SOFTWARE

(Provided by JAZZ IMAGING)

FUSION enables you to integrate the JAZZ IMAGING Sensor natively into your existing DEXIS Dental Imaging Software.


2. If the JAZZ Autostart Menu screen is not automatically shown, open the windows file explorer manually and click on the Drive associated with the JAZZ IMAGING USB KEY (usually “D:) and Click on the file “JazzAutoStart.exe.”


3. In the Software Applications Section of the Jazz

Autostart Menu, choose “FUSION with existing Imaging Software”

NOTE: To close the JAZZ Autostart Menu screen click on the “X”. To return to the JAZZ Autostart Menu Homescreen click on “Back” on the bottom right of the screen.

4. Select the corresponding “FUSION for DEXIS Version” in the “FUSION for DEXIS” section of the Jazz AutoStart Menu screen. Follow the instructions.


3.7.2.2 FUSION WITH EXISTING GENDEX / GxPicture / VixWin DENTAL IMAGING SOFTWARE


FUSION enables you to integrate the JAZZ IMAGING Sensor natively into your existing GENDEX / GxPicture / VixWin Dental Imaging Software.


2. If the JAZZ Autostart Menu screen is not automatically shown, open the windows file explorer manually and click on the Drive associated with the JAZZ IMAGING USB KEY (usually “D:) and Click on the file “JazzAutoStart.exe.”

3. In the Software Applications Section of the Jazz

Autostart Menu, choose “FUSION with existing Imaging Software”


NOTE: To close the JAZZ Autostart Menu screen click on the “X”. To return to the JAZZ Autostart Menu Homescreen click on “Back” on the bottom right of the screen.

4. Click on the “FUSION for GENDEX / GxPicture / Vixwin” in the “FUSION for GENDEX / GxPicture / VixWin” section of the Jazz AutoStart Menu screen. Follow the instructions.

3.7.2.3 JAZZ HARMONY AUTOBRIDGE FOR PRACTICE MANAGEMENT SOFTWARE


AUTOBRIDGE by JAZZ Harmony is a practice management bridge which JAZZ IMAGING offers to its users and works in the same fashion for all Practice Management systems that it supports. You open up your Practice Management Software > Select a Patient > go to the charting module > AUTOBRIDGE will automatically launch (displaying any past exams if you have them) > By clicking on the JAZZ IMAGING icon in the upper right corner, the patient is launched and a layout can be selected.

Currently the follow practice management software are supported:

PracticeWorks (Carestream) Softdent (Carestream) Easy Dental (Henry Schein) Eaglesoft (Patterson)

AUTOBRIDGE installation is performed during the standard installation of JAZZ Harmony. Please refer to the JAZZ Harmony User Manual for instructions on how to install AUTOBRIDGE.


3.7.2.4 NATIVE BRIDGING (Provided by Practice Management Provider)

Native bridging is programed, provided and supported by the practice management provider and will function in a similar way to the AUTOBRIDGE, except that there is a button directly embedded into the practice management software which will call/activate the JAZZ IMAGING Software once it is clicked.

Currently, the follow practice management software manufacturers offer native bridging:

Open Dental PracticeWeb EZ2000)

Daisy (DMC) Genesis

Please contact the supplier of your practice management software for instructions on how to bridge your JAZZ IMAGING SENSOR with their software.

3.8 INSTALLING THE JAZZ IMAGING WALL MOUNT

The JAZZ Imaging Sensor Wall Mount is designed for several mounting options: (1) Wall-mounted with fastening hardware, or (2) Attached to a wall or other acceptable bonding surface with an adhesive. When installing JAZZ Imaging Sensor Wall Mount, choose a location that offers easy access and visibility during patient exams.

JAZZ Imaging Sensor Wall Mount


3.8.1 Wall-Mounting Option (with Adhesive)

IMPORTANT! When choosing a location for the wall mount, make sure there are no electrical wires or connections that could be contacted accidentally when drilling.

Install the JAZZ Imaging Sensor Wall Mount by attaching the holder to a wall or other flat surface, as follows:

1. Remove the JAZZ Imaging Sensor and USB Cable from the

holder.

2. Locate an accessible, stable, and flat surface for the Wall Mount.

3. Remove one side of the Velcro tape from the Wall Mount.

4. Peal off the adhesive tape from the rear of the Velcro and attach the Velcro to a wall or other flat surface.

5. Attach the wall mount securely.

6.

3.8.2 Wall-Mounting Option (with Fasteners)

IMPORTANT! When choosing a location for the wall mount, make sure there are no electrical wires or connections that could be contacted accidentally when drilling.

The JAZZ IMAGING Sensor Wall Mount is designed to store the sensor, USB connecter and sensor cable. Install the holder by fastening it to a wall or other flat surface, as follows:

1. Remove the JAZZ Imaging Sensor from any holder.

2. Position the wall holder on a smooth stable flat surface. Using the holes on the back of the wall mount as guides, fasten the holder securely to the wall using two (#4) dry wall screws (note supplied) or other hardware appropriate to the mounting surface.


3.9 Storing the Sensor and USB Cable on the Wall Mount

The JAZZ IMAGING Sensor Wall Mount is designed to store the Sensor and USB-connecter on a wall or other flat surface securely and safely and provide a solution to ensure that the sensor cable is not left lying on the floor when not in use.

This is achieved by folding up the sensor cable in one (max. two) large loops and placing the sensor cable in the designate area behind the sensor und USB/connecter.

Image Wall Mount 1

Image Wall Mount 2


4 OPERATION

4.1 PRECAUTIONS DURING X-RAY OPERATION

Always observe the safety guidelines and precautions supplied with your X-Ray generator and by local regulatory authorities.

4.2 CONNECTING YOUR JAZZ SOLO SENSOR TO THE USB-PORT

IMPORTANT! Do not connect the JAZZ SOLO Sensor to your computer until AFTER you have successfully installed the Jazz Control Center (Section 2.5).

The JAZZ SOLO Sensor is shipped with a USB "Type-C" connecter. Four USB cables with 2 different lengths are also provided. Use these (USB Type C to USB Type A) cables to connect the JAZZ Solo Sensor to any available USB 2.0 or USB 3.0 port on the computer.

4.3 THE JAZZ IMAGING EASY POSITIONING SYSTEM

We have developed the JAZZ IMAGING easy positioning system to enable fast, precise and ergonomic positioning with the JAZZ IMAGING Solo Sensor. Unlike other universal sensor holders that are available on the market, each positioner consists of just one piece, without the need to connect different shaped bars and rings for each clinical region. The one same positioning ring fits onto all positioners, making the use of the system simple and fast.

The JAZZ IMAGING easy positioning holders maintain all the positive attributes of the JAZZ IMAGING sensor, as no sharp areas are added to the sensor, maintaining the same patient comfort that would otherwise only be available without using a sensor and holder. We recommend always using these sensor holders, which are included with your JAZZ IMAGING sensor to obtain consistent image quality.

Please invest a little time to become acquainted with your JAZZ IMAGING sensor and the JAZZ IMAGING easy positioning system. The JAZZ IMAGING sensor with its unique design using advanced ergonomic features, including the 4 missing four corners and slim rounded casing. This in combination with correct placement, enabled by the JAZZ IMAGING easy positioning system, will result in optimal patient comfort.


4.3.1 POSITIONERS DELIVERED WITH THE JAZZ IMAGING EASY POSITIONING SYSTEM

The JAZZ IMAGING easy positioning system is delivered with the following components:

JAZZ Imaging Easy Positioners

(Not all show holders are part of the initial shipment

NOTE: We highly recommend the immediate purchase of additional holders and rings, to efficiently use the JAZZ Imaging Easy Positioning System on a daily basis.

Anterior Holder (1 shipped as part of the positioning kit)


Posterior Holder UR / LL (1 shipped as part of the positioning kit)

Anterior Holder UL /LR LL (1 shipped as part of the positioning kit)

Horizontal Bitewing Left / Right (1 shipped as part of the positioning kit)


Vertical Bitewing Left / Right (not shipped as part of the positioning kit)

Positioning Ring (1 shipped as part of the positioning kit)


4.3.2 ASSEMBLING THE JAZZ IMAGING SYSTEM EASY POSITIONING SYSTEM

Assembling each single holder and the ring is simple with the JAZZ IMAGING easy positioning system as each holder is color coded and can only be fitted to the positioning ring with the correct orientation. (Where the entire sensor area is visible in the center of the ring) This applies to all holders (anterior, posterior, horizontal or vertical bitewing) holders, as the same positioning ring with only one hole fits onto each holder.

WARNING

A new hygienic sheath must be placed on the sensor for each new patient.

Place a protective sheath over the sensor.

Depending in the tooth region you would like to X-Ray choose the appropriate JAZZ IMAGING sensor holder and attach the sensor to the positioner.

To protect the cable when the patient closes to bite on the positioners bite block, position the sensor cable as close and parallel to the bite block as possible to avoid the patient from biting on the sensor cable when acquiring the image.

4.3.3 APPLYING THE PARALLELING TECHNIQUE WITH THE JAZZ IMAGING EASY

POSITIONING SYSTEM

The JAZZ IMAGING Solo Sensor, in combination with the supplied JAZZ IMAGING easy positioning kit, uses the paralleling technique. This technique places the sensor in the mouth so that it is parallel to the long axis of the tooth and perpendicular to the interproximal spaces. If you draw an imaginary line through the occlusal/incisal surfaces (occlusal line) of the teeth to be X-Rayed, and place the sensor parallel to this line, it will be perpendicular to the interproximal spaces. To simplify parallel positioning, the sensor (holder) should be positioned as far away from the lingual/palatal surface as possible (further towards the center of the mouth) in all areas except for mandibular molars, where there is usually enough space available to place the sensor (holder) directly behind the mandibular molar teeth.


NOTE: When patients bite down on the positioners, please always ask them to close their mouth slowly and bite lightly, so that they have only the slight contact. Hard and access biting is uncomfortable for the patient and will create unnecessary strain on the holders and sensor. Do not allow patients to bite down on the cable. If you unsure about the patients cooperation, place an object such as a folded gauze or cotton roll on the tab, to hold the teeth open just enough to keep the cable from harm. Alternatively, you can place the cable in an area where there are missing teeth or in an area where, anatomically, there is an open space or lack full occlusion.

4.3.3.1 MAXILLARY ANTERIOR POSITIONING

Position the blue anterior sensor holder so that it is parallel to the roots of the teeth. Once you establish that the sensor holder is parallel to the roots, move the sensor holder toward the center of the palate. Ask the patient to close end-to-end in order to maintain the placement. In the event that the holder does not remain parallel to the roots, bisect your angle. If a large maxillary torus is present and you are unable to place the sensor/holder in a traditional position, the sensor/holder must be placed on the torus as you would place traditional film and you must bisect your angle.

Should the incisal edges be missing from your images when images are acquired, place a cotton roll or flap between the tooth and the holder and/or verify that the sensor holder is parallel to the roots.


4.3.3.2 MAXILLARY POSTERIOR POSITIONING

Position the sensor/holder so that it is parallel to the roots of the teeth. Once you establish that the sensor/holder is parallel to the roots and parallel to the occlusal line, move the sensor/holder toward the center of the palate. Ask the patient to close. In the event that the holder does not remain parallel to the roots, bisect your angle. If a large maxillary torus is present and you are unable to place the sensor/holder in a traditional position, the sensor holder must be placed on the torus as you would place traditional film and you must bisect your angle.


4.3.3.3 MANDIBULAR ANTERIOR POSITIONING

Position the sensor holder so that it is parallel to the roots of the teeth. Place either under the tongue or over the tongue, whichever is most comfortable for the patient. If large mandibular tori are present, position the sensor holder behind the tori, even if it is in the first molar area. Ask the patient to close end-to-end in order to maintain the placement.

In the event that the holder does not remain parallel to the roots of the incisors, bisect your angle. Should the incisal edges be missing when acquiring your images, place a cotton roll or flap between the tooth and the holder and/or verify that the sensor holder is parallel to the roots.


4.3.3.4 MANDIBULAR POSTERIOR POSITIONING

Position the sensor/holder so that it is parallel to the roots of the teeth. Place either under or over the tongue, whichever is most comfortable for the patient. Once you establish that the sensor/holder is parallel to the roots and parallel to the occlusal line, move the sensor/holder to the mid-line. Ask the patient to close. In the event that the holder does not remain parallel to the roots of the premolars, bisect your angle.


4.3.3.5 BITEWING POSITIONING (HORIZONTAL / VERTICAL)

Position the sensor/holder so that it is parallel to the occlusal line, move the sensor/holder toward the midline. Ask the patient to close.

4.4 USE OF PROTECTIVE SHEATHS

IMPORTANT! Use protective sheaths every time the Jazz Imaging Sensor is used. Never use the Sensor without a protective sheath. Never use a damaged sheath. Always dispose of the sheath after every patient.

Protective sheaths are single-use devices and must not be reused under any circumstance. Reuse of single-use devices/instruments may cause them to become contaminated, compromise their intended function, and result in patient and user infection, injury and/or illness.


5 HYGIENE / CARE / MAINTENANCE IMPORTANT! Like all electrical equipment, the JAZZ Imaging sensor requires not only correct use, but also visual inspection, prior to operation, and routine checks at regular intervals. These precautions will help ensure that the JAZZ Imaging Sensor operates accurately, safely and efficiently.

Before operating the JAZZ Imaging System, users shall check it for any signs of physical damage or defect. If detected, contact JAZZ Imaging for further instructions.

IMPORTANT! Be sure to disconnect the JAZZ SOLO Sensor from the USB/Port before performing any cleaning procedures.

No patient is needed to perform the cleaning or maintenance of the JAZZ IMAGING system.

Under normal operating conditions, the expected life of the JAZZ SOLO Sensor is five years.

5.1 HANDLING

5.1.1 PROTECTING YOUR SENSOR FROM POTENTIAL DAMAGE

Like other electronic devices, your JAZZ SOLO Sensor is susceptible to electrostatic discharge (ESD), particularly when the device is used in or around carpeted areas or low-humidity environments. Using anti-static floor mats or floor treatments can also help eliminate static build-up in your office.

5.1.2 AVOIDING DAMAGE TO THE JAZZ SOLO SENSOR CABLE

To avoid strain on the cable by ensuring that you:

Always use the provided extension cable provided with your sensor

Do not roll over the cable with dental chairs Remove the cable from the PC by pulling the USB plug and

NOT on the cable. Avoid bending the cable sharply. Avoid tripping over the cable. Use the wall mount to store the JAZZ SOLO and USB

connector.


5.2 CLEANING / DISINFECTION

NEVER PLACE OR BATH THE SENSOR IN DISINFECTANT

NEVER STERILIZE OR AUTOCLAVE THE SENSOR

The Jazz Imaging Sensor should be thoroughly cleaned after each use. The following cleaning and disinfection recommendations are intended to accomplish intermediate-level disinfection and will prepare the product to be safely used and reused during its lifetime. All cleaning and maintenance should be performed by a dental professional.

Jazz Imaging Easy Positioning Holders should also be cleaned and disinfected after each use. All other Sensor positioning accessories, such as aiming rings and holders, should also be cleaned and disinfected following manufacturer’s instructions.

Hygienic barriers (sheaths) should always be used when placing the sensor into a patient’s mouth and disposed of after use. Never re-use a hygienic barrier (sheath) on a different patient!

The following surface disinfectant has been found to be effective in achieving a desired level of disinfection and are available from your dental suppliers:

Cavi Wipes (Metrex)

Cidex OPA (Johnson & Johnson)

Sani Cloth (PDI)

70 % Isopropyl alcohol


5.2.1 CLEANING THE JAZZ IMAGING SENSOR

In a clinical environment, a health care professional should wear protective disposable gloves and perform the following steps. Before every new patient, the following protocol is recommended:

1. Remove and discard all protective hygienic barriers and / or sheaths from the Sensor.

2. Place the Sensor on a tray covered by a disposable liner, or in a receptacle that has been thoroughly disinfected.

3. Remove and discard gloves.

4. Wash hands and put on a new pair of disposable gloves.

5. Disconnect the JAZZ Imaging Sensor from the USB-Interface.

6. If the Sensor or cable are visibly contaminated (e.g. with blood or saliva), each should be cleaned with a soapy cloth or paper towel, and then dried with a clean lint-free cloth or paper towel.

7. Thoroughly spray or wipe the Sensor and cable with one of the disinfecting products recommended above. Do not soak the Sensor USB-connector in any amount of liquid.

8. If using a spray disinfectant, allow it to remain on the Sensor for five minutes. If using a liquid disinfectant, allow it to remain on the Sensor for 30 seconds.

9. Repeat Steps 7 and 8. When the Sensor has been sprayed or wiped two times, continue with the following steps.

10. Remove potential chemical build-up from the Sensor by wiping it with a lap sponge saturated with de-ionized water.

11. Use a dry lap sponge to dry the Sensor or cable, as needed.

12. Place the Sensor in a clean environment, ready for next use.

13. Reconnect the Sensor.



5.2.2 STERILIZATION OF JAZZ IMAGING EASY POSITIONING - SYSTEM (HOLDERS &

RINGS)

In a clinical environment, a health care professional should wear protective disposable gloves and perform the following steps. Before every new patient, the following protocol is recommended:

1. Remove and discard all protective hygienic barriers and / or sheaths from the sensor and holders.

2. Place the holder(s) to be autoclaved on a tray or in a receptacle.

3. If the holder(s) is/are visibly contaminated (e.g. with blood or saliva), each should be cleaned with a soapy cloth or paper towel.


5. Place single holder(s) and/ or ring(s) into a separate sterilization pouch.

6. Place the packaged holder(s) into the middle tray of the autoclave. Ensure that the holders do not touch the autoclave walls or heating element.

7. Autoclave at either 250˚F (121˚C) / 15psi for 20 min. or 270˚F (132˚C) / 30psi for 10 min.

o DO NOT EXCEED 270˚F (132˚C) o DO NOT EXCEED 20 min. (250˚F) or 10 min (270 ˚F) o DO NOT use phenol-based glutaraldehyde o DO NOT cold sterilize o DO NOT CHEMICLAVE or DRY-HEAT STERILIZE o DO NOT use special application or ultrasonic

cleaners

8. Leave the holders in the sterilization pouch and place the holder(s) / ring in a clean environment, ready for next use.


5.3 MAINTENANCE

5.3.1 PERIODIC MAINTENANCE

Periodic maintenance should be performed as needed, but at least once a month by a qualified dental professional trained in the use of intraoral digital x-ray equipment. It consists of various checks performed by the operator or by a qualified service technician.

1. Using a metal test object of your choice, check that, over time, there is no deterioration in regard to image quality, in comparison to a previously acquired image of the same test object.

Identical kV, mA, exposure times must be used

The X-Ray generator settings should represent the settings otherwise used to acquire patient images

ensure the distance between the selected object and the x-ray tube is always identical and between 4-6 Inches.

All acquired maintenance images should be saved in the used dental imaging software in the same predefined area (patient file), to enable later comparison of the acquired maintenance images and provide image history

The X-Ray generator settings (kV, mA and time) should be noted and attached to each acquired image for later reference

NOTE: Do not take test images on patients to periodically check the consistent image quality. If any deterioration of image quality (resolution or contrast) is evaluated please immediately refrain from using the JAZZ Solo Sensor and contact customer service.

2. Check that the housing and cable of the JAZZ IMAGING Sensor is intact.

3. Check that the JAZZ Imaging Sensor label is intact, readable and adheres well to the surface on which it is positioned.

4. Check that the USB/connecter of the JAZZ IMAGING Sensor is undamaged.

5. Check that the JAZZ IMAGING Easy Positioning Holders and Rings are undamaged.


6 WARRANTY / PARTS / SUPPORT

6.1 WARRANTY

Your JAZZ IMAGING System comes with an unlimited warranty as long as the monthly subscription contract is active and payments are up to date.

6.2 DAMAGED SENSOR

In the event of obvious physical damage to a JAZZ SOLO Sensor, customers shall discontinue use of that Sensor immediately. Please disconnect the JAZZ SOLO Sensor from the PC by pulling the USB Connecter from the computers USB port. Please substitute another JAZZ SOLO sensor (if available) and contact JAZZ Imaging for further instructions.

6.3 JAZZ SENSOR REPLACEMENT

In the rare case of a technical defect of your JAZZ SOLO Sensor, a cost free replacement will shipped to your office

WARNING! No modification of the JAZZ SOLO Sensor is allowed. There are no user-serviceable parts in the JAZZ SOLO Sensor. Opening the sensor will void the warranty.

Continued use of a damaged sensor or a sensor that is not achieving the intended image quality, may expose the patient to unnecessarily high amounts of ionized radiation or increase the likelihood of clinical miss-assessment.

If you experience any problems with the JAZZ SOLO Sensor, please contact JAZZ IMAGING by calling:

Tel. (567) 234 5299 ext. 300 or via our website: (www.jazzimaging.com/support).


6.4 PART NUMBERS (SENSOR / JAZZ IMAGING EASY POSITIONING - KIT

/ACCESSORIES)

The following table provides customer-orderable part number information for the JAZZ IMAGING Sensor and JAZZ IMAGING Easy Positioning Kit.

JAZZ IMAGING System - Part Numbers

ITEM

QUANTITY SHIPPED

PART

NUMBER

JAZZ SOLO Sensor

1

10-001

JAZZ Imaging Sensor Holder Anterior Upper / Lower

1

21-013

JAZZ Imaging Sensor Holder Posterior Upper Right / Lower Left

1

21-015

JAZZ Imaging Sensor Holder Posterior Upper Left / Lower Right

1

21-014

JAZZ Imaging Sensor Holder Bitewing Horizontal Left / Right

1

21-016


JAZZ Imaging Sensor Holder Bitewing Vertical Left / Right

0

21-017

JAZZ Imaging Positioning Ring (fits all JAZZ Sensor Holders

2

21-012

Sensor Wall Holder

1

21-030

`

X-Ray Mount

1

50-004

6.5 WEB-SUPPORT / CUSTOMER-SERVICE HOTLINE

Should you experience any problems with the JAZZ Imaging Sensor, please contact JAZZ IMAGING by calling:

Tel. (567) 234 5299 ext. 300 or via our Website: (www.jazzimaging.com/support)


6.6 FREQUENTLY ASKED QUESTIONS (FAQ)

ITEM

DESCRIPTION

POSSIBLE CAUSE

CORRECTIVE ACTION

1 Imaging software does not detect Sensor

JAZZ Imaging Sensor is not connected to the computers USB-Port

Connect the JAZZ Imaging Sensor to the USB-Port

If already connected, unplug and plug into a different USB-Port

Restart the PC

2


7 SAFETY, SPECIFICATIONS AND STANDARDS

7.1 SAFETY

7.1.1 SYSTEM INSTALLATION AND OPERATION VERIFICATION

The JAZZ SOLO Sensor has been determined to be in accordance with international safety standards and is deemed suitable for use within the patient area, which extends from the patient for a distance of 5 ft (1.5m). To comply with these standards, do not operate non-medical equipment (such as a PC workstation) inside the patient area. Outside the patient area, the presence of approved non- medical grade equipment and Listed / Approved / IEC 60950-1 certified Information Technology Equipment (ITE) computer equipment is acceptable.

The host computer (PC workstation) should be CE-approved and conform with the Low Voltage [73/23/EC] and EMC Directive [89/336/ERC]. Also, to help ensure optimal performance, ensure that all software programs residing on the workstation are virus-free and have been adequately tested so they will not impact imaging applications after installation.

Assurances should be made to enable easy access to the USB Port of the computer or hub, to ease disconnection of the JAZZ SOLO Sensor.

During use, the user should not touch the USB-Connecter and the JAZZ IMAGING SENSOR at the same time.

7.1.2 AUTHORIZED DESIGNEES PERMITTED TO OPERATE THE SYSTEM

To ensure the correct use of the Jazz Imaging System in a clinical environment, for purposes that correspond to its intended design and application, only dentists, or their designees, trained in the use of digital X-Ray equipment are authorized to operate the system.

7.1.3 USE OF PARTS THAT WERE NOT DELIVERED WITH THE JAZZ IMAGING SYSTEM

Only items delivered with the Jazz Imaging System or specified for use with the system in this User’s Guide, should be connected or used. If, however, use with adjacent equipment is necessary, normal operation should be observed and verified in that configuration.


7.1.4 AVOIDING UNAPPROPTIATE ACTIVATION OF THE X-RAY SOURCE

To avoid exposing the patient or user to unnecessary X-Rays, ensure that the Jazz Imaging Sensor is connected and the software is activated and prompting for the acquisition of a patient image before activating the X-Ray source.

7.1.5 RISK OF RECIPROCAL INTERFERENCE DURING SPECIFIC

INVESTIGATIONS OR TREATMENTS

There are no known risks of reciprocal interference when using the JAZZ IMAGING system; however, we do advise that no other electrical devices should reside in the patient’s mouth while using the JAZZ IMAGING system.

7.1.6 CORRECT DISPOSAL OF JAZZ SOLO SENSOR

The JAZZ SOLO containing materials and electrical components that could contaminate land-fills or water supplies and result in severe human or environmental health issues.

Penalties may be applicable for not disposing of your JAZZ SOLO sensor in accordance with national legislation.

US:

Please contact your local authorities and ask for the correct method of disposal or designated collection points where JAZZ SOLO sensors will be accepted on a free-of-charge basis.

EU:

The sensor should be returned to either your distributor or JAZZ Imaging when a hardware defect occurs or the expected end of service life is reached.


7.2 SPECIFICATIONS AND STANDARDS

The JAZZ Imaging System has passed North American Safety Certification and also complies with international EMC, safety, and quality standards listed below:

ITEM

VALUE

EMC/Safety

IEC60601-1:2005 Ed 3 +Al:2012

Medical Electrical Equipment – Part 1: General Requirements for basic safety and essential performance

AAMI ES60601-1:2005+AC1;A2

Medical Electrical Equipment – Part 1: General Requirements for basic safety and essential performance (R2012) CSA C22.2:60601-

1:2014 Ed 3 Medical Electrical Equipment – Part 1: General Requirements for basic safety and essential performance CENELEC EN

60601-1:2006 +C1;A11;A1

Medical Electrical Equipment – Part 1: General Requirements for basic safety and essential performance

IEC60601-1- 2:2014

Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility

Usability

IEC 62366: 2007+A1 2014

Medical Devices – Application of Usability Engineering to Medical Devices

IEC 60601-1-6 Ed 3.1: 2013

General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability

Classification Class II, Type BF Applied Part Mode of Operation Equipment is intended for continuous use

X-Ray Source Suitable for x-ray generators operating in the 60-70kV range with a minimum of 40uGy incident dose. X-ray source my conform to IEC 60601-2-65:2012.

U

SB

Supply Voltage +5V DC (derived for PC USB port) Supply Current 350 mA Max Power Consumption

0.7 W Max

Weight 1.8 oz. (50g) Cable Length 6 ft (nominal) + 12 inch extension

SEN

SOR

Technology CCD, 18um pixel Resolution Capability >20 lp/mm

Active Sensor Area 34.9 x 26.3mm (not including chamfered corners)

External Dimensions 39.1 x 30.0mm (not including chamfered corners)

E

NV

IRO

NM

EN

T

Transport and Storage Conditions

Ambient temperature range: -40°F (-40°C) to 140°F (+60°C) Relative humidity range: 10 to 100%, including condensation Atmospheric pressure range: 500 hPa to 1060 hPa

Operating Conditions

Ambient temperature range: 50F (+10°C) to °86F (+30°C) Relative humidity range: less than 75% Atmospheric pressure range: 700 hPa to 1060 hPa

Sterilization Not suitable for sterilization

Ingress Protection IPX7

Restricted service statement

Unless otherwise specified, this unit should be serviced only by the manufacturer. It contains no user-serviceable parts.


7.2.1 LEAKAGE CURRENT STATEMENT

The Jazz Imaging Sensor complies with the leakage current requirements of IEC 60601-1 safety standard. Variations, however, may exist in the construction of computers to which the JAZZ Imaging Sensor is connected. Customers are advised to have a qualified electrician perform a leakage test on their equipment before using the JAZZ Imaging Sensor.

The JAZZ Solo Sensor in combination with IT components forms a medical, electrical system. IT hardware used to run the JAZZ SOLO Sensor shall conform to the IEC 60950-1 standard. Please refer to the IEC 60601-1 standard.

7.2.2 EMC TABLES

The following tables provide the JAZZ Imaging Sensors compliance information to electromagnetic compatibility (EMC) and electromagnetic immunity (EMI) standards. To ensure conformance, the customer or user must use the JAZZ Imaging Sensor in environments that are consistent with these standards.

The JAZZ Imaging Sensor should not be extended with any USB extension cables, other than those provided by JAZZ Imaging, as compliance to EMC and EMI standards cannot be guaranteed when other extension cables are used.

7.2.2.1 DECLARATION- ELECTROMAGNETIC EMISSIONS

PLEASE NOTE: The JAZZ SOLO Imaging Sensor is intended for use in the electromagnetic environment specified below.

The customer or user of the JAZZ SOLO Imaging Sensor must ensure that it is used in such an environment.

EMISSIONS TEST

COMPLIANCE

GUIDANCE

Radiated Emissions CISPR 11

Class A The JAZZ SOLO Imaging Sensor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Conducted Emissions CISPR 11

Class A

The JAZZ SOLO Imaging Sensor is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.


7.2.2.2 DECLARATION- ELECTROMAGNETIC IMMUNITY

PLEASE NOTE: The JAZZ Imaging Sensor is intended for use in the electromagnetic environment specified below.

The customer or user of JAZZ Imaging Sensor must ensure that is used in such an environment.

IMMUNITY TEST

IEC 60601 TEST

LEVEL

COMPLIANCE

LEVEL

GUIDANCE

Electrostatic discharge (ESD) IEC 61000-4-2

±15 kV contact

±8 kV air

±15 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient/burst IEC 61000-4-4

±2 kV, 5/50 nsec pulse, 100 kHz repetition freq.

±2 kV, 5/50 nsec pulse, 100 kHz repetition freq.

Mains power quality should be that of a typical commercial or hospital environment

Surge IEC 61000-4-5

±1 kV differential mode

±2kV common mode

±1 kV differential mode

±2kV common mode

Mains power quality should be that of a typical commercial or clinical environment

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT)

for 5 sec

< 5% UT (>95%

dip in UT) for 0.5

cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

< 5% UT (>95%

dip in UT) for 5

sec

Mains power quality should be that of a typical commercial or clinical environment. If the user of the JAZZ Imaging System requires continued operation during mains interruptions, it is recommended that the PC workstation to which the JAZZ Imaging Sensor is connected be powered from an uninterruptible power supply or battery

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30A (rms) 30A (rms) Mains power quality should be that of a typical commercial or clinical environment

Continuous Conducted RF IEC 61000-4-6

80% AM (1kHz) 3 Vrms 0.15 MHz to 80 MHz 6 Vrm in Bands within 0.15 MHz to 80 MHz

80% AM (1kHz) 3 Vrms 0.15 MHz to 80 MHz 6 Vrm in Bands within 0.15 MHz to 80 MHz

Portable and mobile RF communication equipment should be used no closer to any part of the JAZZ Imaging System, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

d = 1.2 P


IMMUNITY TEST

IEC 60601 TEST

LEVEL

COMPLIANCE

LEVEL

GUIDANCE

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz, 80% AM at 1 kHz & Proximity fields from RF Wireless communications

3 V/m 80 MHz to 2.7 GHz, 80% AM at 1 kHz & Proximity fields from RF Wireless communications

d = 1.2 P for 80 MHz to 800 MHz

d = 2.3 P for 800 MHz to 2.7 GHz

Where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range b

Interference may occur in the vicinity of equipment marked with the following symbol

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the JAZZ Imaging System used exceeds the applicable RF compliance above, the JAZZ Imaging Sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the JAZZ Imaging Sensor. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.


7.2.2.3 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT AND THE JAZZ IMAGING SENSOR

PLEASE NOTE: The JAZZ Imaging Sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or user of the JAZZ Imaging Sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the JAZZ Imaging sensor as recommended below, according to the

maximum output power of the communications equipment.

RATED MAXIMUM OUTPUT

POWER OF THE TRANSMITTER

(W)

SEPARATION DISTANCE ACCORDING TO THE

FREQUENCY OF THE TRANSMITTER (M)

150 kHz to 800 MHz

d = 1.2 P

800 MHz to 2.5 GHz

d = 2.3 P

0.01 0.12 0.23

0.1 0.38 0.73 1 1.2 2.30 10 3.8 7.3 100 12.0 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.


7.3 SYMBOLS

JAZZ Imaging products display a number of markings which indicate compliance with regulatory requirements or which provide information in accordance with applicable technical standards.

Symbols

SYMBOL

DESCRIPTION

Indicates Class II equipment in accordance with applicable medical device safety standards (IEC/EN/UL 60601-1)

Indicates Type BF equipment in accordance with applicable medical device safety standards (IEC/EN/UL 60601-1) The sensor housing and cable are considered applied Parts

Indicates that this product meets North American Safety

Standards. The ETL mark is a Nationally Recognized Testing Lab (marking and indicates conformance with ETL 60601-1)

IPX7

Protection against continuous immersion in water

Manufacturer

Date of Manufacture

Catalog Number


Serial Number

Product is electrical equipment. Do not dispose with general waste. Contact local authorities to obtain disposal instructions.

jazz solo user manual - jazz imaging solo user manual rev d.pdfjazz solo sensor is a suitable...

Documents