2 Introduction to the AuditPro System
Nanosonics AuditPro is an infection control workflow compliance management system, which incorporates the following advantages:
• It standardizes ultrasound infection prevention practices;
• helps meet accreditation requirements; and
• delivers best practice patient care across facilities and organizations.
The automated and secure system combines clinician infection prevention decision making with infection control workflow data and a Patient Procedure ID. Figure 1 below shows the process workflow of the AuditPro system, including the interaction of the devices and software used.
Nanosonics AuditPro also guides the operator to ensure that the disinfection procedures follow the Spaulding Classification, as well as relevant country regulations, standards and guidelines.
All data is stored in secure AWS cloud environments that are HIPAA and GDPR-compliant, with fast access and secure backup.
The Nanosonics AuditPro system is intended to integrate with trophon2. For further information on the trophon2, see [2].
Figure 1: AuditPro (high level) Data Flow Diagram
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Nanosonics AuditPro is not compatible with the trophon EPR devices, the first generation trophon device. |
2.1 The Nanosonics AuditPro System
This section describes the Nanosonics AuditPro system hardware and software components which are designed to be used with the clinical workflow at point of care, such as within patient examination rooms.
2.1.1 Physical devices
The Nanosonics AuditPro package contains:
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• 1 x Nanosonics AuditPro Mobile Scanning Device |
See Nanosonics Mobile Scanning Device |
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• 1 x USB (5 volt) power supply |
See Docking Station and Wall Charger |
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• 1 x Nanosonics AuditPro Quick Start Guide |
Figure 2: Nanosonics AuditPro System
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Optionally, trophon2 devices may be ordered with your Nanosonics AuditPro package. |
There are additional physical devices and networking infrastructure required to run AuditPro which are not included in the AuditPro package and are listed in the following subsections below.
2.1.1.1 Additional Nanosonics Devices
The following Nanosonics devices (depicted in Figure 3) are required to use the AuditPro system:
• trophon2 device
• trophon AcuTrace Medical Instrument Tags
• trophon AcuTrace Operator Card
Figure 3: Additional Nanosonics Components
During the operation of the trophon2 device, the trophon AcuTrace Operator Card and Medical Instrument Tags uniquely identify the operators and probes being used. This is achieved through programming the relevant fields onto the RFID tags or cards.
For more information about trophon AcuTrace Operator Cards, Medical Instruments Tags and their use with trophon2, see [2].
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Reliability of the reprocessing data collected depends on a unique one-to-one correspondence between: • Operators and their trophon AcuTrace Operator Cards Not doing so may compromise the traceability of the Operators and Probes using trophon2 devices. |
2.1.1.2 Networking Infrastructure
A facility needs to have appropriate devices and networking capabilities to optimise the function of the AuditPro system.
The client should provide the following IT infrastructure:
• Ethernet cabling to connect trophon2 devices to the facility ethernet ports
• Further networking devices for Wi-Fi connectivity of the trophon2 devices (e.g. switches, routers, Wi-Fi access points)
• 1 x computing device with compatible web browser to access the internet. (See Compatible Browsers)
2.1.2 Nanosonics Mobile Scanning Device
The Nanosonics AuditPro Mobile Scanning Device is a Wi-Fi enabled Android device running only the Nanosonics AuditPro Mobile Application and MDM service application.
The features are shown in Figure 4.
Figure 4: Nanosonics AuditPro Mobile Scanning Device Features
| 1. Power Indicator 2. Scan Indicator 3. Display 4. Function Key 5. Home Key 6. Return Key 7. Power Button |
8. Scan Button |
15. Battery Cover 16. String Buckle 17. Speaker 18. Battery Cover Safety Lock 19. Battery Cover Safety Button 20. Charging Contact 21. USB Cover |
2.1.2.1 Docking Station and Wall Charger
Figure 5: Mobile Scanning Device Docking Station, Wall Charger and Power Supply
The docking station conveniently stores and supplies power to your Mobile Scanning Device. It is recommended to keep the Mobile Scanning Device fully charged to ensure it is always ready for use.
The wall charger is provided with a selection of power plugs (see Figure 5) suitable for all regions where Nanosonics AuditPro is sold. The cable can connect the wall charger to the docking station or charge the Mobile Scanning Device directly from a USB power outlet.
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For best functionality, a Mobile Scanning Device should be installed with each ultrasound console at clinical point of care. |
2.1.2.2 Charging the Mobile Scanning Device
Figure 6: Connecting the Wall Charger to the Docking Station
To charge the Mobile Scanning Device
1. Choose the correct plug type for your region and connect the plug to the wall charger by pushing the plug against the halfway point of the charger and sliding down wards, as shown in Figure 6.
2. Connect the wall charger to the docking station with the provided USB cable.
3. Once connected and charging, an orange light will turn on and turning green once fully charged. The battery symbol on the top right corner of the Mobile Scanning Device will indicate when the battery is fully charged.
2.1.2.3 Cleaning
Use trophon2 Companion Cleaning Wipes to clean all accessible surfaces (except the charging contacts) of the Mobile Scanning Device as required, until visibly clean.
See the following link for additional approved cleaning solutions: https://sps.honeywell.com/us/en/support/blog/productivity/honeywell-disinfectant-ready-housing-cleaning-and-disinfecting-guide
2.1.3 Software Components
There are three software components to the Nanosonics AuditPro software:
| Nanosonics AuditPro Mobile Application |
The Nanosonics AuditPro Mobile Application is preinstalled on the Nanosonics AuditPro Mobile Scanning Device. The software provides procedure logging at the clinical point of care and activates real-time notifications if a logged procedure does not meet Spaulding Classification requirements. |
| Nanosonics AuditPro Mobile Device Management (MDM) |
Provides a secure network connection, and updates the device operating system and the AuditPro Mobile Application to the latest version. |
| Nanosonics AuditPro Cloud Application |
The Nanosonics AuditPro Cloud Application consists of a cloud-based system and associated software which can be accessed via commonly available web browsers. For a list of compatible web browsers, see Compatible Browser. The AuditPro Cloud Application: • Produces audit-ready reports that display linked probe, patient, procedure data, and dashboards. Launch your browser and navigate to www.nanosonicsauditpro.com to access the Nanosonics AuditPro Cloud Application. |
2.1.3.1 Compatible Browsers
Compatible browsers are listed below, along with their earliest compatible version:
• Microsoft Edge 16
• Google Chrome 74
• Apple Safari 13
• Internet Explorer 111
1 Note that Internet Explorer is to be deprecated. Users should migrate to one of the other Web browsers.
2.1.3.2 Mobile Scanning Device management and settings
The Mobile Scanning Device runs Android MDM application which allows controlled access to apps and settings. The settings detailed in the following subsections can be adjusted without restriction.
To view information and follow instructions in the next sections, you must be able to unlock the device and ensure the device is connected to Wi-Fi, see the next subsection for instructions.
2.1.3.2.1 Unlock and Reset Mobile Scanning Device PIN
All Mobile Scanning Devices, when purchased, have a default PIN of 1234. For security purposes, it is recommended to change the default PIN before first use.
When assigning new PINs, ensure to conform to your facility guidelines. Consider how and where a Mobile Scanning Device will be used. It may be convenient to assign a unique PIN to all Mobile Scanning Devices in a particular facility or department, to allow any AuditPro operator to use any of the Mobile Scanning Devices in that location.
To Change Device PIN
1. Unlock your Mobile Scanning Device by pressing the Power button on the top left of the device (see the Side Views pane in Figure 4), then swipe up from the bottom of the screen until you see the following screen. (Figure 7- 1)
2. Key in the default PIN using the on-screen keyboard. As delivered, the default PIN is 1234 and tap the green enter icon.
3. The Nanosonics AuditPro Application screen should be displayed, see Figure 7-2. Tap the arrow icon at top right of the screen. You will then see the screen shown below in Figure 7- 3
4. Tap Settings. A list of settings will appear, see Figure 7-4
5. Tap Screen Lock.
6. Enter the default PIN: 1234.
7. Tap PIN. Enter the new PIN and tap NEXT.
8. Re-enter the new PIN and tap OK.
9. Exit by tapping the left arrow ← next to Settings.
Figure 7: Mobile Scanning Device Settings
2.1.3.2.2 Lost/Forgotten Access Code (PIN)
If you have lost or forgotten the Nanosonics AuditPro Mobile Scanning Device PIN, you can request Nanosonics Customer Service to reset it.
Note that the Mobile Scanning Device must be connected to the facility Wi-Fi before the Nanosonics service team can reset the PIN remotely.
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In the case where the device cannot be connected to Wi-Fi, the device will need to be reset to factory settings to change the password. This will delete all existing unsynced procedure data in the device. All devices are required to be constantly connected to the facility network as instructed. |
2.1.3.2.3 Connecting to a Wi-Fi Network
Obtain the Wi-Fi network name and password from your IT department to connect a Mobile Scanning Device to your facility Wi-Fi.
To Connect a Mobile Scanning Device to your Wi-Fi network:
1. Unlock your Mobile Scanning Device using your PIN.
2. In the Settings screen, tap Wi-Fi.
3. Ensure the Wi-Fi is ON and connected to the internet. In the list of Wi-Fi networks that appears, tap the one your IT department provided. See Figure 8.
4. In the next screen fill in the Wi-Fi password your IT department provided.
5. Return to the Nanosonics AuditPro Home page by tapping the Return key on the bottom left of the device (see figure 4 Front View ⑥).
Figure 8: Wi-Fi Settings
2.1.3.2.4 Other Device Settings
The Settings screen Figure 7-4 allows you to adapt the Mobile Scanning Device to your needs.
Settings which may be useful are:
• Sound level
• Display brightness
• Screen timeout
2.1.3.3 Mobile Scanning Device Application Updates
The Mobile Device Management (MDM) application will maintain the software and SSL Certificate on the Mobile Scanning Device, as necessary.
Updates may include:
• The operating system or its components
• Security patch
• Nanosonics AuditPro Mobile Application
The MDM checks the mobile application version when registering a new Mobile Scanning Device to a facility. It may take about 5 minutes (depending on your network speed) to update the application before you can register the Mobile Scanning Device.
Procedures can continue to be logged during update. It is recommended that the user reboots the device as soon as possible after updates have installed to access new features and improvements to the software.
The update process takes one of two paths, depending on the criticality of the update:
1. Regular update process - No critical issue, minor feature updates.
The process will:
1.1. Send a message to the Mobile Scanning Device and an email to the Facility Administrator containing details of the update and update schedule 72 hours ahead of the update.
1.2. Download and install the update silently in the background.
1.3. Provide an option on the Mobile Scanning Device instructing the user to reboot the device to complete the installation of the patch.
See Regular Update Process Workflow for a user view of this process.
2. Critical update process - Major vulnerability detected, needs immediate update.
This process will:
2.1. Send a notification to the Mobile Scanning Device and an email to the Facility Administrator containing details of the update and the update schedule 72 hours ahead of the update.
2.2. Download and install the patch silently in the background.
2.3. Automatically reboot the device, no user action required.
Note that this type of update will be scheduled outside normal working hours as much as possible to avoid interruption.
Once you receive notification of an update (during the notified update schedule) you must ensure that the Mobile Scanning Device:
• remains powered on until the update has taken place
• is connected to its charger
• is connected to the Facility network.
2.1.3.3.1 Mobile Scanning Device Messages
Messages are sent to your Mobile Scanning Device when there is a mobile application or kernel patch update. A notification will be displayed on the top right corner of your Mobile Scanning Device screen. Notifications are visible once the device is unlocked using the PIN.
To access these messages, tap the message notification on the top right of your screen. Figure 9 gives an example of a message page.
Figure 9: Message Page
2.1.3.4 Regular Update Process Workflow
An example of a software update that requires operator interaction to reboot the Mobile Scanning Device is described below.
To Reboot the Mobile Scanning Device after an update:
1. When a software update is taking place, a symbol next to the Wi-Fi icon on your lock screen will appear (see Figure 10-1)
2. When the update has been downloaded and is ready to install, a message to that effect will appear on your lock screen (see Figure 10-2)
3. Unlock your Mobile Scanning Device. A symbol on the top left corner of the screen will indicate a pending message (see Figure 10-3)
4. Swipe down from the top of the screen to reveal the message. (See Figure 10-4) The Mobile Scanning Device can be rebooted by tapping Reboot or by using the Power button on the left side of the device, see Figure 4 Side View ⑦. Note that after critical updates, devices will automatically restart.
Figure 10: Update in Progress
