NEMA XR-29 Compliance
FDA 510(k) Cleared
Become NEMA XR-29 (MITA SmartDose) compliant with Zetta Medical Technologies, developed, tested and Implemented XR-29 solution. Zetta is proud to introduce Z-DOSE29. Zetta is the only independent service provider in the market that is your single source for this software. Zetta's new product development team of engineers, clinical and applications specialists developed our Z-DOSE29 based on our customers' needs and in compliance with the NEMA XR-29 standard. Z-DOSE29 Interfaces with CT scanners from major OEMs: GE, Siemens, Philips and Toshiba. Z-DOSE29 is FDA 510(k) cleared and it complies with the NEMA XR-29 standard attributes.
Z-DOSE29 10 key advantages:
FDA 510(k) Cleared and NEMA XR-29 Compliant
Dose Notifications/Alerts appear on the CT (or PET/CT) operator's console as required by the XR29/XR25 standard(s)
DICOM Radiation Structured Dose Report transfers automatically to ACR Dose Index Registry (via TRIAD)
Automatic record keeping with encrypted storage
Z-DOSE29 is a network node; it connects to scanner via facility network
Small footprint installation with no attachments to the scanner hardware (no added monitor, keyboard or mouse)
No modification to scanner's hardware or software
Installation in 2 hours and 12 months warranty
Clinical applications training on-site
Designed and Developed in the USA. 24x7 USA based support.
Contact Zetta or call us at 800-991-1021 to schedule a Z-DOSE29 webinar and an online demo. You can also review the Frequently Asked Questions section and watch on-line videos of Z-DOSE29 interacting with different CT scanners.
Features & Benefits:
|Patient Dose Monitoring & Structured Dose Reporting||Keep your existing equipment. Avoid paying for scanner replacement|
|Compliant with NEMA XR-29 standards||Maximize your insurance reimbursements|
|On-Site and Web-Based solutions||Keep your XR-29 upgrade costs low. One Company, One Product, One Number|
|Lifetime product support||Minimize downtime and upgrade delays|
|Transferable to future CT equipment purchases||99% uptime guarantee|
|Interfaces with products from major OEMs: GE, Siemens, Philips & Toshiba||Fast& Flexible Implementation|
In addition to providing the NEMA XR-29 compliant Radiation Structured Dose Report (RSDR), Z-DOSE29 includes a user freindly reports and charts. Directors and administrators can review this live data from the comfort of their computers. Up-to-date information to compare dose values by patient, by physician, by protocol, by technologist or even by scanner type on their network. This is valuable information that can help the healthcare provider make informative decisions about dose values and exposure. Click on the thumbnail images below to enlarge.
What are the four attributes of the NEMA XR-29 standard?
Z-DOSE29 complies with the 4 attributes of the NEMA XR-29 standard:
- DICOM Radiation Dose Structured Report: Enables recording of post exam dose information in a standardized electronic format. This information can be included in the patient record, promoting the establishment of diagnostic reference levels, as well as facility dose management and quality assurance.
- CT Dose Check: Incorporates two features—dose notifications and dose alerts—that warn operators and physicians when dose exceeds established thresholds
- Automatic Exposure Control (AEC)*: Automatically adjust the amount of radiation within prescribed bounds as needed to achieve the desired image quality. Studies of AEC procedures have demonstrated dose reductions when used properly.
- Pediatric and Adult reference protocols: A set of pre-loaded parameters on a CT system that can be selected by the operator to complete a particular clinical task, such as capturing an image of the abdomen.
* AEC/Dose modulation feature must be installed on the scanner to qualify for our upgrade
What is Z-DOSE29?
Z-DOSE29 is an intuitive dose monitoring device developed by Zetta Medical Technologies to make your CT scanner compliant with the XR-29 standard, CMS and Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) dose monitoring requirements. It is considered non-invasive, meaning no changes to the CT scanner hardware of software are required. It connects to your network (just like a PACs system) and it interacts with the CT scanner through secure, precise and fast networking techniques.
Is Z-DOSE29 a FDA 510(k) cleared device?
How Does Z-DOSE29 Work?
The setup process takes a couple of hours and it includes the time for physical installation needed to connect Z-DOSE29 to your network. Through secure networking protocols and proprietary connectivity algorithm Z-DOSE29 interacts with your CT scanner to determine the CTDi and DLP values for each series and notifies the CT technologist of any values exceeding the predefined threshold. It also records these values in a database for the department manager to view dose reports and charts. Dose Check notifications appear on the display screen of the CT scanner in front of the technologist. The technologist will have the opportunity to modify the parameters to lower the dose values. Alternativey, the operator can enter a reason for exceeding a dose threshold for these situations where it is necessary to do so.
For each study, and as Z-DOSE29 adds up the CTDI values for every series (and automatically records it in the database), it tracks the sum of all values to ALERT the technologist if the total sum for one study reaches 1000mGy. This alert condition is a safety feature to ensure patient's safety and protects the healthcare provider as well as the operator. In this case, scanning can not begin until a password is entered to unlock the generation of X-Ray. Simultaneously, an electronic alert notification will also be sent to the facility director of this high dose condition.
Z-DOSE29 collects the data needed to generate a comprehensive Radiation Structured Dose Report and prepares it for transfer to the ACR Dose Index Registry (DIR). A user-friendly database of dose information is also provided to allow supervisors and department directors to access the data and generate a multitude of reports ad charts to measure performance and operations. These reports are detailed and can be shared with CMS, JCAHO and ACR professionals to demonstrate dose management and tracking capabilities. Access to this Dose Database is secure with unique username(s) and password(s).
For healthcare providers with multiple facilities and different locations we offer Z-DOSE29 PLUS to give you a centralized server to view all Dose data in one easy application with secure connectivity and secure multiple users log-ins.
Training of your technologists for Z-DOSE29 and Z-DOSE29 PLUS is part of what we do. We offer on-site training for your team and back it with telephone and remote support to make sure you are always up and scanning.
What are the requirments for dispalying Dose Notifications and Alerts?
Dose Notifications/Alerts must be dispayed on the CT (or PET/CT) Operator's Console and not on any other alternative/external monitors. This is a basic requirment for any solution to comply with the XR-29 standard. Z-DOSE29 displays the dose notifications/alerts on the operator's console; without the need to utilize any external (and unnecessary monitors). Here is an excerpt from NEMA XR-25 Computed Tomography Dose Check, section 2.1.2:
“2.1.2 Checking Prior to SCANNING The NOTIFICATION VALUE(S) for the current PROTOCOL ELEMENT(S) shall be visible to the operator prior to confirmation of the PROTOCOL ELEMENT GROUP. When a PROTOCOL ELEMENT GROUP is confirmed, the system shall display a notification (see 2.1.4) on the operator’s console if the estimated CTDIvol or DLP exceeds the corresponding NOTIFICATION VALUE(S). The notification shall be displayed prior to the start of the SCAN, and shall never interrupt the SCAN.”
Also the MITA letter "Is-Your-CT-Smart-Dose-Compliant-Whitepaper.pdf" issued in May 2015 states clearly that the Dose Notifications MUST appear on the CT Operator Console for the CT to be compliant.
Excerpt from Page 2:
The CT Dose Check ......
..... dose related notification and alert messages must appear on the operating console of the CT scanner prior to starting a scan in order for the system to be compliant...."
And Page 3:
"d. Dose Check: Do alerts and notifications appear on the operating console of the CT scanner prior to starting a scan? "
What is the purpose of the password in case of a Dose Alert situation?
Both NEMA XR-29 (which also includes XR-25) and Z-DOSE29, require the operator to input a secure password (prior proceeding to scan) if the total CTDI value for the study will exceed the total threshold value (as determined by the healthcare provider). Unless the correct password is entered, the scanner's operator will not be able to start scanning. This feature is a requirement of the XR-29 standard. Please see the excerpt from the NEMA XR-25 Computed Tomography Dose Check section 2.2.2 below:
“2.2.2 Checking Prior to SCANNING
To proceed with SCANNING when an ALERT VALUE has been exceeded, the system shall require the operator to enter his/her name and reconfirm the chosen PROTOCOL ELEMENTS before proceeding to the SCAN. The system shall also provide password-protection capability that prevents execution of the SCAN unless the correct password is entered.
What scanners (make/model) is Z-DOSE29 compatible with?
We have installed Z-DOSE29 on this list of scanners.
Would Zetta issue a Certificate of Compliance for Z-DOSE29?
Yes, as required by the NEMA XR-29 standard, Zetta issues the Customer a certificate of compliance, certifying that your scanner (with Z-DOSE29) complies with the published attributes of NEMA XR29-2013 for CT Equipment Related to Dose Optimization and Management, (as referenced in Section 218 of the Protecting Access to Medicare Act of 2014, 42 USC §1395(p)) and incorporates each of the four attributes of XR-29 standard.
Are there any videos to show Z-DOSE29 displaying dose notifications and alerts on the CT operator's console?
See the following YouTube videos for Z-DOSE29 working with:
Is there a return on investment calculator that can help me decide to purchase a XR-29 solution?
Yes, calculate your ROI to see the Return On Investment for your XR-29 upgrade. Select Year 2016 or 2017 or the number of scans per day (per CT scanner) and different other variables to see your break-even point.
What is MITA's Independent Vendor Evaluation Guide and what are Zetta's answers to their questions?
MITA offers healthcare providers an Evaluation Guide of Independent Vendors offering XR-29 solutions. Please click the following link to read Zetta's answers to the evaluation guide questions to see how Z-DOSE29 meets your requirements. MITA's Independent Vendor Evaluation Guide for XR-29
Can you provide customer references for your Z-DOSE29?
Yes, we can provide you with a reference list of customers who purchased Z-DOSE29 . Also see more feedback on our Customers Testimonials page.
I purchased Z-DOSE29, what form do I need to complete to schedule my installation?
After completing the purchase agreement for Z-DOSE29 please submit the following Z-Dose IT form to schedule the installation.