1 Introduction
This document, with the Nanosonics AuditPro™ Quick Start Guide, comprise the Nanosonics AuditPro user documentation.
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1.1 Intended Use
The Nanosonics AuditPro system, when used in accordance with its labelling, is a traceability system that links medical instrument reprocessing cycles to specific patient procedures. Nanosonics AuditPro manages and displays medical device data to support audit information needs and assist healthcare facilities to manage infection prevention measures.
Nanosonics AuditPro is used in healthcare settings, by healthcare workers. The system provides continuous on-the-job reprocessing compliance according to Spaulding Classification and facility SOP into the clinical workflow.
1.2 References
[1] Nanosonics AuditPro Quick Start Guide
[2] trophon2 User Manual
[3] Nanosonics AuditPro Implementation Success Guide
[4] trophon2 Companion Cleaning Wipes
1.3 Terms and Acronyms
Table 1: Table of Terms or Acronyms
| Term or Acronym | Definition |
| Accession Number | A unique identifier generated by the Facility medical record system to identify a specific medical event related to a specific patient. |
| AWS | Amazon Web Services. |
| Department | A department refers to a specific area within a facility. For example: Radiology, ICU, IVF, Emergency, Coronary Care. |
| DHCP | Dynamic Host Configuration Protocol |
| Facility | Hospital, clinic, or another site where probe reprocessing is performed. A Facility is associated with a unique physical address. |
| GDPR | General Data Protection Regulation |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| HLD | High Level Disinfection describes a process that completely destroys or eliminates all microorganisms, with the exception of small numbers of bacterial spores. |
| ILD | Intermediate Level Disinfection describes a process that can kill mycobacteria, viruses, most bacteria and fungi, but does not kill bacterial spores |
| LLD | Low Level Disinfection describes a process that can kill most bacteria, some viruses and some fungi. |
| MDM | Mobile Device Management |
| OCR | Optical Character Recognition – technology which recognizes text within an image. |
| Organization | Group of Facilities. |
| Patient Procedure Identifier (Patient Procedure ID) | A unique code that identifies a specific medical event related to a specific patient. Example Identifiers include Accession number, Activity Identifier, Episode Number. The Patient Procedure ID type is determined by your Department or Facility. |
| SOP | Standard Operating Procedure |
| Spaulding Classification | An internationally adopted framework for disinfection and sterilization of medical device developed by Earle H. Spaulding. |
| SSO | Single Sign-On - an authentication method that allows users to sign in using one set of credentials to multiple independent software systems. |
| Sterilization | Sterilization describes a process that completely destroys or eliminates all forms of microbial life. |
| trophon2 | A registered Nanosonics product compatible and supported by Nanosonics AuditPro. The second generation trophon device that shares the same core technology of ‘sonically activated’ hydrogen peroxide as the trophon EPR. |
