wiki SIMDENSITY

SIMDENSITY - Instructions for Use 

	(01) 05905799286206 (11) 231130 (21) 1.0.0.
	SIMDENSITY v 1.0.0.
	VISUAL TECH-LAB Sp. z o.o. Ignacego Mościckiego 1 24-110 Puławy Poland
	2023-11
	eIFU: wiki.simdensity.com
	Class: IIa TUV…

Electronic version of the Instructions for Use ver. 1.0 (2023 / 11 / 30)

Information:

1. The intended user of the software is a professional user with a high level of competence and professional experience: a medical specialist in dentistry and implantology, with appropriate experience in anatomical analysis and clinical reasoning/diagnostics based on diagnostic medical imaging such as computed tomography, and fluent in English for professional purposes (the software interface is available only in English);
2. Use of the device requires familiarization with the Instructions for Use supplied by the manufacturer;
3. A detailed description of the procedure and an explanation of how to interpret the results indicated by the software;
4. A detailed description of the input files supported by the SIMDENSITY software;
5. Information that the system user - the doctor - should verify the patient data (update function);
6. Only examinations performed using the density phantom and of appropriate quality should be uploaded to the SIMDENSITY system;
7. A detailed description of the file upload process;
8. Information that Internet access is required to use the SIMDENSITY software;
9. The minimum input-file resolution specified as voxel size;
10. Instructions for setting the appropriate field of view - recommended XX - and voxel size (resolution) - recommended 0.125 mm;
11. Manufacturer contact details and information on how to report software problems;
12. Information on minimum hardware and software requirements for using the SIMDENSITY system, including:
    
    a. Recommended web browsers;
    b. Minimum computer technical specifications;
13. The density phantom has a declared expiry date; after that date it will not be possible to perform an examination in the SIMDENSITY software;
14. Information on the availability of the IFU in PDF format for registered users;
15. Explanation of the icons and symbols used in the software;
16. Explanation of the available views (3 planar views and 1 3D view, with 1 to 4 images displayable on the screen), as well as menu placement and collapsible tab icons;
17. Explanation of when individual user-interface elements, such as messages, appear and disappear;
18. Information on the correct sequence of actions in the system;
19. Minimum hardware and system requirements;
20. Explanation of the color scale used;
21. Information that, in addition to the color scale, the user screen also displays numerical density values for each color in the system;
22. Minimum hardware and system requirements;
23. Information on registration and login using 2FA;

Learn how to register with simdensity.cloud, log in and manage your account. 

¶ Registration in the SIMDENSITY system

To register with the SIMDENSITY system, select “Register” 

In the next step, select the registration method 

First registration

Select the Company Owner / Administrator tile

and click the “NEXT” 

Then enter the login details for your SIMDENSITY system account. 

Next, enter the details of the company that will handle financial settlements and will be the payer for services. 

It is important to provide the correct VAT / TAX number. These details will be verified by the VISUAL TECH-LAB sp. z o.o. team. 

If you will only manage the account in the SIMDENSITY system, do not select additional roles: DOCTOR or RADIOLOGIST.

If you are a sole practitioner / single practice and you are a Doctor, select the “DOCTOR”. 
If you do not do this, you will be able to assign the role after registering your company in the system. 

If you are a Doctor and perform CBCT scans in your own practice, select the “DOCTOR” tile and the “RADIOLOGIST" 

In the next step, select the two-factor verification method used during login. 

• by e-mail - the 2FA code will be sent to the e-mail address provided during registration
• by SMS - the 2FA code will be sent by SMS to the phone number provided during registration

By clicking the button 

At this stage you can also add branches / locations of your company, which you will then be able to manage. 

NOTE: 

Branches that do not have their own tax identification are not separate business entities and will be settled through the main account in the simdensoty.cloud system. 

If your company has branches that have separate tax identification and therefore constitute separate business entities, they must create separate Company Owner / Administrator accounts for settlement purposes.

¶ Doctor / Radiologist registration in the SIMDENSITY system 

Registration of a Doctor / Radiologist who is not an administrator (Company Owner) is performed on the basis of a registration invitation sent by the Company / Clinic / Practice administrator. 

A registration invitation for the SIMDENSITY system is sent to the e-mail address specified by the Company Owner. 

To register, click the link provided in the e-mail or copy it and paste it into the browser address bar. 

You will be redirected to a page where you will be asked to enter your login details. 

Then create your individual Login name: 
and a password for your SIMDENSITY account. 

Then select the appropriate tile to define your role in the system if the role has not already been assigned by your company administrator. 

Next, enter your personal information.  

In the next step, select the two-factor verification method used during login. 

• by e-mail - the 2FA code will be sent to the e-mail address provided by the administrator during registration
• by SMS - the 2FA code will be sent by SMS to the phone number provided during registration

Then click the button 

Information that the registration form has been completed will be sent to your company administrator, who will approve your request. You will be notified by e-mail. 

Enter the login name and password that you used during registration. 

• Select the checkbox accepting the terms of use - I accept the terms of use
• Click “LOGIN"

• The next step is to enter the two-factor authentication (2FA) security code:
  • if you selected SMS for two-factor authentication in your profile, enter the code received on your phone.

• if you selected e-mail for two-factor authentication in your profile, enter the code received at your e-mail address.

Bone-density examination results screen 

¶ Your SIMDENSITY account

To verify the registration details and make changes, click “Login as” in the upper-right corner of the screen.

Your account details will be displayed: 

All changes are confirmed with the “SAVE” button in the lower-right corner of the screen. 

After logging in to the SIMDENSITY system at simdensity.cloud, if you have multiple assigned roles, click the “Role” drop-down list in the upper-right corner and select the required role to change roles. 

After a role is selected, the system adjusts the left-hand menu to show the functions assigned to that role. 

System roles

¶ Doctor 

A system role intended for a logged-in System User, providing access to the following functions:
 

• Patient card 
• Examination results 
• Examination orders
• Review of ordered examinations
• Reviewing the history and status of DICOM files added to the system
• Reports  
   

¶ Radiologist

A system role intended for a logged-in System User, providing access to the following functions:
 

• Handling a Doctor's order: adding DICOM files and verifying the patient
• Managing density phantoms
• Reviewing the history and status of DICOM files added to the system
• Reports

¶ Administrator / Company Owner 

A system role intended for a logged-in System User, providing access to the following functions:
 

• Patient card 
• Examination results 
• Examination orders
• Review of ordered examinations
• Managing density phantoms
• User management
• Company branch/location management
• Billing
• Reports

System functions

¶ Patients

• Adding a new patient to the patient registry 
• Viewing patient data 

¶ Adding a new patient

To add a new patient on the “Patients” tab: 

• click the button at the bottom of the tab

• Then complete the fields.

NOTE:

It is best to enter the PESEL number or National ID as the Patient ID. If this is not possible for any reason, assign your own 11-digit patient number. 

The Patient ID is the value that will be verified when the patient is referred to another radiology diagnostic facility outside your organization or to an internal radiology diagnostic facility. 

• Then click the button SAVE  at the end of the tab.

¶ Viewing patient data

To view the patient's examination history: 

• Search for or select a specific patient from the list.

Then click the icon at the end of the patient's basic-data row.

For each patient, the examination history is available, together with the option to view and repeat an examination using the DICOM files added to that examination. 

Examinations - this tab contains ordered examinations, with sorting and search options. 

To search for an examination, enter the examination number or Patient ID. 

The examination list contains the following information (with sorting available): 

• Analysis date 
• Examination number 
• Patient name 
• Name of the doctor who ordered the examination 
• Examination expiry date 
• Link to view the active examination 

On this tab (upper-right corner) there is a list of your examinations divided into: 

1. Only examinations ordered by you
2. Examinations available from other workstations at the assigned location
3. All examinations from the entire company

• To order a new examination, select a patient from the list or enter the assigned Patient ID number.

• After selecting the patient
• Click the button NEXT
• Confirm / verify the patient data.

Click the button  NEXT

Next, define the source of the DICOM files. You can select *.dcm file resources from a folder available to you, refer the patient for a tomographic examination at a radiology service provider known to you, refer the patient to a radiology facility that is part of your organization, or refer the patient to any radiology facility selected by the patient. 

NOTE: 

For any location outside your practice or practice network, the patient must be informed that the radiology facility is required to have an account in the SIMDENSITY system. DICOM images acquired without a density phantom authorized in the simdensity.cloud system cannot be used for bone-density analysis. 

The available options are: 

1. I have direct access to the DICOM file repository
2. I do not have a DICOM file - send the patient to a radiologist

select:  I have a DICOM file with a density phantom, go to upload and analyze if you have access to the CBCT examination results as *dcm files go here 

select: I don't have a DICOM file, send this patient to a radiologist if you do not have access to the DICOM files go here

If you do not have direct access to DICOM file resources, you can refer the patient for a CBCT examination using one of the following options: 

• CBCT examination at your own practice - your own radiology facility
• refer the patient for an examination to an external radiology facility cooperating with your practice
• refer the patient to any radiology facility selected by the patient. 
  NOTE: the patient must be informed that the examination must be performed using the density phantom.

Referring a patient for an examination to an external radiology facility cooperating with your practice. 

To refer a patient to a radiology facility cooperating with your practice, click the radio button labeled: Select radiologist and send SMS

Then select the radiology facility to which you are referring the patient from the drop-down list or on the map and click the “NEXT”

In the next step, the simdensity.cloud system generates an order summary that can be sent to the patient by SMS (the patient's phone number is provided in the patient registry in the system), or printed to a PDF file and sent to the patient at the e-mail address specified by the patient, or printed on a printer and handed to the patient. 

The order card contains: 

• patient details (first name, last name, address)
• Patient ID 
• age 
• sex 
• radiologist identification 
• examination order number 
• PIN CODE 
• patient phone number 

Referring a patient for an examination to a radiology facility located within your organization/company, to your own radiologist. 

To refer a patient to a radiology facility located within your organization/company, to your own radiologist, click the radio button labeled: Radiologist in my company

Then select a radiologist from a branch belonging to your company from the drop-down list and click the “NEXT”

In the next step, the SIMDENSITY system generates an order summary that can be sent to the patient by SMS (the patient's phone number is provided in the patient registry in the system), or printed to a PDF file and sent to the patient at the e-mail address specified by the patient, or printed on a printer and handed to the patient. 

The order card contains: 

• patient details (first name, last name, address)
• Patient ID
• age
• sex
• radiologist identification
• examination order number
• PIN CODE
• patient phone number

Referring a patient for an examination to any radiology facility selected by the patient. 

To refer a patient to any radiology facility, click the radio button labeled: Send a general link so that the patient can choose the radiologist himself/herself

Then click the “NEXT”

In the next step, the simdensity.cloud system generates an order summary that can be sent to the patient by SMS (the patient's phone number is provided in the patient registry in the system), or printed to a PDF file and sent to the patient at the e-mail address specified by the patient, or printed on a printer and handed to the patient. 

The order card contains: 

• patient details (first name, last name, address)
• Patient ID
• age
• sex
• radiologist identification
• examination order number
• PIN CODE
• patient phone number

The Ordered Examinations screen displays information about ordered examinations. 

To search for an examination, enter the examination number or Patient ID. 

The examination list contains the following information (with sorting available): 

• Order number
• Examination order date
• Patient name
• Examination status
  • loaded - DICOM files have been added to the system
  • waiting - awaiting completion
• Actions available for a given examination
  • Make Examinations - perform the bone-density examination analysis
  • Upload files - add DICOM files
  • Print | Resend SMS - resend the SMS to the patient or Radiologist, depending on the referral method selected when creating the new examination. Print the referral for the patient or radiologist.

On this tab (upper-right corner) there is a list of your examinations divided into: 

1. Only examinations ordered by you
2. Examinations available from other workstations at the assigned location
3. All examinations from the entire company

System function available for the role Administrator / Company Owner 

This tab allows you to: 

• view users in your company
• manage user roles
• assign professional activity within branches / locations
• add new users
• search for users
• sort by:
  • System role
  • User name
  • User login
  • assigned branch / location

Role management 

In the selected user row, click “Manage user” 

In the “Role in the system” section, click the role that you want to assign to the user; the tile will turn red. To remove a role, click the corresponding role tile; it will turn white. 

Then confirm the change by clicking “+SAVE” in the lower-right corner of the screen.

Assigning a user to one or more branches / locations 

To add the edited user to a branch / location of your company, select the branch / location from the “Company branch” drop-down list and click “+ ADD BRANCH” 

System function available for the role Administrator / Company Owner 

This tab allows you to: 

• view the list of branches / locations
• search for branches / locations
• manage branches / locations
• add new branches / locations
• assign users (Doctor, Radiologist) to selected branches / locations 

Managing a branch / location 

To add a user to a selected company branch / location, select the user from the “User to Add” drop-down list and then click “+ADD USER”, and then click the button in the lower-right corner “SAVE” 

To remove a selected user from the list for a branch / location, click “Remove From Branch” 

Adding a new branch / location 

To add a new branch, click the “+ ADD BRNACH” button on the main Company Branches tab, then complete the fields below and assign users.

Confirm by clicking “SAVE” at the bottom of the page. 

System function available for the role Administrator / Company Owner 

This tab allows you to: 

• view the balance of funds available for examinations 
• unit cost of an examination in the selected currency 
• view and sort the list of payments in the system 
  • transaction date 
  • gross transaction amount 
  • Payment method 
  • Link to payment details 

Adding funds 

To add funds, click “+ ADD FUNDS”. 

Then select the amount by which you want to top up the simdensity.cloud system and select the payment method. 

Payment methods 

• PayPal 
• Recurring charge to a PayPal account
• Fast transfer through the Cashbill system
• Standard bank transfer 
  • select this option; the system will allow the bank-transfer details to be sent to an e-mail address.

Different report types are available for each role. 

Each report has one common element: 

To generate a report within the scope available for the role, select the required Report type and define the date range and click “GENERATE AND DOWNLOAD”. The system will create an Excel report file, which the browser will begin downloading automatically. 

Doctor 

Available report types 

• My examinations 
• My examination orders 
• Costs of completed examinations 
• Radiologists - examination referrals to radiologists 
• Patients 

Radiologist 

Available report types: 

• My uploaded DICOM files 
• Examinations assigned to me
• List of Doctors ordering examinations

Administrator / Company Owner 

Available report types: 

• Examinations
• Examination orders
• Examination costs

An additional report filter for this role determines whether the report concerns the entire company or selected branches / locations. 

Examination results 

Types of results

The result of the preliminary analysis is an assessment and information about the condition of the DICOM files and whether they can be presented after analysis.  

The density phantom was not detected or the DICOM quality is critically low for the current order. Uploading a new DICOM examination is recommended. No examination fee will be charged. 

DICOM Quality: Excellent 

DICOM Quality: Poor. Rescanning required. The input DICOM file for this examination is of low quality or contains errors, which may result in incorrect presentation of the bone-density assessment output data. 

DICOM Quality: Sufficient

DICOM Quality: Good

• basic patient data - view information about the examined patient

• link to download the examination summary - patient card - “Download cross-section as PDF”
• option to add a comment

• measurement-point size selection

• measurement scale and its assigned colors

The scale presents a bone-density range from 0.00 g/cm3 to 3.10 g/cm3, using colors from gray to burgundy. 
This represents the range from the lowest to the highest density. 

• 3D image presentation
• layers according to the Y-axis orientation
• layers according to the Z-axis orientation
• layers according to the X-axis orientation

• To change / move between layers for the selected axis (X, Y, Z), scroll with the mouse wheel or touchpad over the selected axis window.
• To pan the image in the selected view window, hold the Ctrl key, right-click and hold the mouse button, then move the mouse.

• To rotate the 3D view, hold the left mouse button while moving the mouse in the required direction.
• Point measurement of bone-tissue density is performed by clicking the required examination location. The result is provided for the selected measurement size. Depending on the selected measurement range, the value is provided:
  • for 1 voxel, as the value at the point;
  • for the remaining options, as the value averaged over the selected area.

¶ Creating a patient card. 

The SIMDENSITY system stores examination results for 30 days from the examination date. 

To preserve the examination results, the system allows you to create a “Patient Card”.

Click the “camera” icon located in the bottom bar of each view.

A message will appear on the screen allowing you to: 

• add / SAVE the image to the Patient Card
• DOWNLOAD - download the selected image directly to disk

To create a Patient Card containing the saved images (“SAVE”), click “Download cross-section as PDF”

The system will then open a summary where you can preview the selected images. 

If the included materials are sufficient, click “GENERATE YOUR REPORT” 

The system will automatically create a PDF file and begin downloading it. 

VIEWER icons

reset view
rotate the image 90° left
rotate the image 90° right
reset the 3D image for X, Y, Z orientation
Zoom in
Zoom out
Show / hide layer information
change the view background color
add an image of the view to the report - Patient Card
single-view display of the selected view screen
two-view display of the selected view screens
display all views

Background colors of messages appearing in the lower-right corner of the screen.  

	Warning: the action requires the user's attention. The list of possible messages is shown below.
	"Incorrect username or password", "Please, login first", "Refresh token failed", "Something went wrong", "Invalid invitation", "Invalid 2FA code", "Session is expired, please login.", "Tool id(s) in row(s) {{rows}} are either invalid or  already exist in the system", "Invalid CSV file",  "Invalid PDF file",  "Invalid text file",  "Allowed avatar image types are: .jpg .jpeg and .png",  "Maximum allowed avatar image size is 2MB", "There is no data to export in the current report for the selected parameters",  "VAT number is already registered in the system",  "Company name is already registered in the system",
	No Internet connection. The system cannot perform the operation correctly.
	The action was completed successfully. The list of possible messages is shown below.
	"Files uploaded correctly", "The files has been added to your examination",  "All files uploaded successfully!",  "Reset password code was sent to your email",  "Password reset successfully", ""Registered successfully", "Tool {{id}} edited successfully",  "Tool {{id}} deleted successfully",  "Tool {{id}} disabled successfully",  "Tools uploaded successfully",  "Tools not imported",  "Tool registered successfully",  "Scale uploaded successfully",  "Company updated successfully", "Company added successfully", "Account updated successfully",  "Avatar updated successfully",  "Company user added successfully", "Company user updated successfully", "Company user status updated successfully", "Invitation sent successfully",  "Company branch added successfully",  "Company branch updated successfully", "User added to company branch successfully",  "User removed from company branch successfully", "Company branch deleted successfully", "Report generated successfully",  "File uploaded successfully",

MEANING OF THE SYMBOLS USED 

	Unique device identifier  (1) - UDI-DI code / Global Trade Item Number (GTIN)   (11) - Production date / Production date (YYMMDD)  (21) - Issue, revision / revision
	Medical device
	Manufacturer
	Country of manufacture
	/ Consult instructions for use
	Class: IIa TUV…