Certificates and Conformance Statements


Certified Operations

KaVo, Instrumentarium Dental and Soredex operate according to the following international standards and directives. Our quality assurance complies with these certificate standards, and with the laws and requirements in the United States, Europe, Canada, Japan, China and Brazil. Our products are approved and registered globally. The testing and monitoring of our products is always performed adhering to the standards. Our business operations are monitored and audited by authorities and facilities for healthcare product technology around the world.


Certificates

Company

Valid Until

 DEKRA Certificate EN ISO 9001

Kaltenbach & Voigt GmbH

10.01.2018

DEKRA Certificate 93/42/EC

Kaltenbach & Voigt GmbH

10.01.2018

 DEKRA Certificate EN ISO 13485

Kaltenbach & Voigt GmbH

10.01.2018

 DEKRA ISO 13485 (CMDCAS)

Kaltenbach & Voigt GmbH

10.01.2018

 EC Certificate

PaloDEx GroupOY*

12.04.2020

 ISO 13485:2003

PaloDEx Group OY*

02.19.2019

 ISO 9001:2008

PaloDEx Group OY*

09.14.2018

 ISO 14001:2004
(Environmental Management System Certification)

PaloDEx Group OY*

01.31.2021

 EC Certificate
(Medical Devices Directive)

Instrumentarium Dental

04.12.2020

 ISO 13485:2003

Instrumentarium Dental

02.19.2019

 ISO 9001:2008

Instrumentarium Dental

09.14.2018

 ISO 14001:2004 
(Environmental Management System Certification)

Instrumentarium Dental

01.31.2021

 EC Certificate

Soredex/PaloDEx Group OY*

12.04.2020

 ISO 13485 & 9001 Certificate

Soredex/PaloDEx Group OY*

02.28.2019

 ISO 14001:2004 Certificate

Soredex/PaloDEx Group OY*

01.31.2021

*The  PaloDEx Group OY (auxiliary Soredex PaloDEx Group OY and Instrumentarium Dental, PaloDEx Group OY) quality management system complies with US law 21 CFR part 820 (Quality System Regulation).

 

DICOM Conformance Statements

Statements

Company

 CLINIVIEW™  DICOM Conformance Statement

Instrumentarium Dental

 Invivo DICOM Conformance Statement

Anatomage

 SCANORA™ DICOM Conformance Statement

Soredex

 VixWin™ Platinum DICOM Conformance Statement

Gendex

 DEXIS™ DICOM Conformance Statement

DEXIS™

Scope and Field of Application

The scope of this DICOM Conformance Statement is to facilitate data exchange with imaging equipment and dental imaging software. This document specifies the compliance to the DICOM 3.0 standard. It contains a short description of the applications involved and provides technical information about the data exchange capabilities of the equipment. The main elements describing these capabilities are: the supported DICOM Service Object Pair (SOP) Classes, Roles, Information Object Definitions (IOD) and Transfer Syntaxes.

The field of application is the integration of imaging equipment into an environment of other medical devices and hospital information systems. This Conformance Statement should be read in conjunction with the DICOM 3.0 standard and its addenda.

Intended Audience

These conformance statements are intended for:

  • System integrators of medical equipment
  • Software designers implementing DICOM interfaces
  • DICOM conformance testing and verification

It is assumed that the reader is familiar with the DICOM 3.0 standard. Readers wishing to obtain more familiarity with the content and terminology of DICOM 3.0 standard are encouraged to obtain and review the standard, prior to reading this Conformance Statement. More information on acquiring this document and its updates on the DICOM standard may be found on the website of the National Electrical Manufacturer’s Association (NEMA) at www.nema.org.

 

HIPAA Statements

Statements

Company

 DEXIS™  HIPAA Statement

DEXIS™

The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) require the Department of Health and Human Services to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data.

HIPAA requires that dental facilities safeguard patient privacy and create a protocol to safeguard sensitive information. To help with compliance, DEXIS offers the following information on our software:

  • DEXIS gives you the option of showing only one patient on-screen at any given time. 
  • Always back up your DEXIS data. We provide DEXsafe™, a module that allows you to backup all or a part of your data in one step. We recommend a removable hard disk drive device. Should you need to recover this data, our Technical Support team can offer assistance.
  • When using scanned signatures in DEXwrite, always use a security code. You can change the security code by rescanning the signature.
  • DEXIS X-ray images contain security information. Altered sensor-captured images lose the “Original DEXray by DEXIS” security banner.
  • DEXIS software does not allow email of DEXIS images (DEXIS format) with the viewer (DEXview) that opens them.

For more information on these items, refer to the DEXIS Manual.

As the owner of a DEXIS Digital X-ray System, you’ll need to file a HIPAA Business Associate Agreement with DEXIS, LLC if a DEXIS staff member will come in contact with your DEXIS data. Please download the document below, complete it, and submit either by e-mail or fax as instructed in the document. We will add our signature and send it back to you.

 Additional Information:

Please contact NEAFastAttach for information on electronic transfer through DEXclaim: www.nea-fast.com

For complete HIPAA rules, visit the Department of Health and Human Services website: www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html