3 Getting Ready for Nanosonics AuditPro

This section includes details of Nanosonics AuditPro connectivity and traceability prerequisites.

The latest edition of the ‘Nanosonics AuditPro Implementation Success Guide’ can be provided by your Nanosonics Representative. This will help manage the steps required to achieve successful implementation of Nanosonics AuditPro in your facility.

 

3.1 Connectivity prerequisites

This section includes guidelines for setting up your devices to enable communication between the hardware, the facility intranet and the internet, a mandatory requirement for proper functioning of the system.

 

3.1.1 trophon2 Setup

Nanosonics trophon2 devices are compatible and required to support the use of the Nanosonics AuditPro system by recording probe and operator data using the built-in RFID scanner during HLD probe reprocessing. A trophon2 device is required to program the AcuTrace® Medical Instrument Tags and Operator Cards.

For information on how to program Medical Device Tags, Operator Cards refer to [2].

For general information on installation of a new trophon2 device refer to [2].

To work with Nanosonics AuditPro you must ensure your current trophon2 devices:

	are running software Version 1.5 or greater	See Checking trophon2 Software Version
	have IP Address set up	See Setting trophon2 IP Address
	have AcuTrace enabled	See AcuTrace Settings
	have accurate time and date settings	See Checking the Time and Date
	are connected to the facility intranet

 

 

3.1.1.1 trophon2 UI (User Interface)

The trophon2 UI screen is where you can access the Menu and Settings referred to in the instructions in the following sections.

To access Menu

Select the menu icon in the top left corner of the screen.

 

Figure 11: trophon2 Menu

 

3.1.1.2 Checking trophon2 Software Version

Ensure all trophon2 devices in your facility are running software version 1.5 or later. If the software version is earlier, please contact your Authorised Service Representative to arrange an update to the latest software version.

To check the trophon2 software version

Go to Menu → Information → Device

 

Figure 12: trophon2 check software version menus

Tap Back to return to the UI screen.

 

3.1.1.3 Setting trophon2 IP Address

The trophon2 device supports the TCP/IP protocol. You can set a static IP address, or you can use the Dynamic Host Configuration Protocol (DHCP), which means that the router will assign a valid IP address. Follow the instructions below per your needs.

 

3.1.1.3.1 DHCP IP Address Reservation - Recommended

1. Go to Menu → Settings → Network on trophon2
2. On the Network screen (Figure 13-3), choose DHCP. IP address and related details will be allocated by the router      to the trophon2
3. Record the IP address allocated and request IT team to reserve IP address for each trophon2
4. Tap Save on the Network screen

 

3.1.1.3.2 Setting a static IP address

1. Request your facility IT admin to allocate a static IP address in the router for trophon2
2. Record the Device IP, Subnet Mask and Default Gateway that your IT administrator assigned to the device
3. Go to Menu → Settings → Network on trophon2
4. On the Network screen (Figure 13-3), choose Static IP. Note the DHCP details will be copied to static IP by                default.
5. Update the Device IP, Subnet Mask and Default Gateway with the provided values. Tap Save on the Network            screen.
6. Tap Back to return to the UI screen.

 

Figure 13: trophon2 set IP address menus

 

3.1.1.4 AcuTrace Settings

Enable AcuTrace Workflow via the menu of the trophon2 device to allow an automated HLD traceability system.

To enable AcuTrace on your trophon2 devices

1. Select Menu → AcuTrace → Workflow
2. Tap AcuTrace ON.

Tap Back to return to the UI screen.

 

3.1.1.5 Setting the Time and Date

It is highly recommended that NTP Servers be used to synchronize time and date of your trophon2 devices. Properly configured NTP Servers provide the most accurate time synchronization, which is critical for audit and legal purposes.

If your Facility does not run a local NTP server, see [2] for instructions on how to set the date and time manually.

To enable NTP:

1. Consult your facility’s IT administrator or network parameters expert and obtain network settings for a time server.
2. Be sure your trophon2 device is connected to the internet, normally via your local network. See Network definition      below.
3. Select Menu → Settings → Date and Time.
    Set the timezone and select NEXT.

NOTE: It is important to ensure the correct timezone is set in order for the DST to update correctly.

4. Select Set automatically ON and enter the settings for your time server address.
5. Choose 12- or 24-hours clock and select NEXT.

NTP provides your trophon2 device with Co-ordinated Universal Time (UTC). Your device will use this to calculate the time in the local timezone that has been set.  The time setting will periodically synchronize with the UTC. The device will update the time when DST starts and ends according to the timezone set.

It is the responsibility of the facility to ensure accurate time, timezone and date settings for all trophon2 devices. Failure to do so will impact the accuracy and reliability of the Nanosonics AuditPro database.

 

3.1.2 Networking your Medical Facility

Nanosonics AuditPro has been built to account for a variety of organizational structures. At the highest level is the Organization, which is a grouping of associated Facilities, where a facility is considered a physical address. Each facility may contain a number of departments, see the example in Figure 14 below.

Figure 14: Example of an organizational structure

 

Figure 15: A networked Organization

AuditPro functionality allows networking and communication of the software and equipment across the Organization. Consider Figure 15 which shows typical Nanosonics AuditPro networking scenarios.

The Nanosonics AuditPro system must, at a minimum consist of one trophon2 device and one Mobile Scanning Device within a single Facility. This scenario is envisioned as existing in the same location in a single Facility, for example Figure 15, Subnet 1.

A single Facility may have more than one reprocessing site. For example, see Figure 15, Facility 1 where the facility contains multiple subnets.

The networking requirements of the AuditPro system are as follows:

Mobile Scanning Device

Connects to your Facility intranet only via Wi-Fi. Requires a Wi-Fi signal of adequate strength at locations where the devices will be used. In the event a clinical procedure location has no or poor Wi-Fi connectivity, logged procedures will be stored on the internal memory of the device. When the device is reconnected to Wi-Fi, the procedures will be uploaded and deleted from the internal memory.

 

The Mobile Scanning Devices must be able to connect to the internet to send their data to the Cloud application. It is the customer’s responsibility to ensure Mobile Scanning Devices are always powered and connected to Wi-Fi to transfer data to the Cloud Application. Procedures logged on devices that do not have Wi-Fi connectivity may be irretrievably lost if the device is lost, stolen or damaged, affecting record accuracy and audit results.

 

trophon2

Each trophon2 device must be linked to a Mobile Scanning Device to function on the network. To link these devices, perform the Initial Registration procedure (see Initial Registration) For best performance, a Mobile Scanning Device should only be linked to a single trophon2 device, however, a Mobile Scanning Device can be linked to up to 10 trophon2 devices.

Linked Devices on the Facility Network

Mobile Scanning Devices and trophon2 devices that are linked should be configured on the same Facility Intranet subnetwork. However, different subnetworks may be configured, as long as each trophon2 device can connect to its linked Mobile Scanning Device. Mobile Scanning Devices may be employed to only log patient procedures. These need not be linked to trophon2 devices and can be configured on their own subnetwork. Devices linked to a trophon2 should always be connected to the Facility Wi-Fi to allow recording of procedure data to the Cloud Application and to transmit trophon2 data to the cloud.

 

When a Mobile Scanning Device connects to a trophon2 device on a different subnet, occasional timeouts may occur if intra-subnet communications are not implemented in an efficient manner.

 

AuditPro Cloud Application

The AuditPro Cloud Application is accessed via a web browser. Procedure logs and trophon2 data are sent to the Cloud Application via the internet.

 

3.2 Traceability Prerequisites

The fundamental delivery of the Nanosonics AuditPro system is to perform the function of a basic traceability system that links medical instrument reprocessing cycles to specific patient procedures. This requires all procedure elements to be uniquely identified.

This section sets out the traceability prerequisites that allow Nanosonics AuditPro to link reprocessing cycles, patient procedures and the devices involved.

 

3.2.1 Medical Records System

The Nanosonics AuditPro system requires that the Facility in which it is used has a medical records system in place.

The Nanosonics AuditPro system allows for the use of either:

•   Patient Procedure IDs, Exam ID; or
•   other non-identifiable procedure identifier

Patient Procedure ID is 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 the Department and Facility and should be documented in the relevant SOP.

 

3.2.2 AcuTrace

Nanosonics supplies trophon AcuTrace Medical Instrument Tags and trophon AcuTrace Operator Cards for traceability purposes (see Additional Nanosonics Devices). These must be programmed with unique identifying information and remain associated with the device or operator.

Prior to launching Nanosonics AuditPro ensure:

	All trophon2 devices have AcuTrace enabled. See AcuTrace Settings for details.
	All probes have a programmed trophon AcuTrace Medical Instrument Tag attached.
	All trophon2 operators are assigned a programmed trophon AcuTrace Operator Card.
	All cards and tags are programmed, using a trophon2 device, with uniquely identifying data. See [2].

 

All trophon2 devices have AcuTrace enabled. See AcuTrace Settings for details.

 

It is important that all trophon AcuTrace Medical Instrument Tags and Operator Cards are programmed with unique information and that they remain associated with the instrument or operator permanently. It is the responsibility of the Facility to ensure that any changes made to AcuTrace Operator Cards and Medical Instrument Tags are accurately tracked and that these changes can be traced back to the Nanosonics AuditPro Cloud Application database, to preserve its integrity. Reprogramming of AcuTrace Operator Cards and Medical Instrument Tags should only be performed to correct mistakes.

 

3.3 Initial Registration

To begin using AuditPro in your Facility, a Facility Administrator needs to follow the steps below to set up the system:

1.  Setup their Admin account
2.  Authenticate their registered email address
3.  Setup the Facility account
4.  Register trophon2 devices and network connections
5.  Register the Mobile Scanning Devices
6.  Link trophon2 to Mobile Scanning Device

Once the Initial Registration has been completed, Administrators can edit Facility details, manage users and devices, and add probe details. (See Further Registrations) It is recommended that Administrators should review the following once Initial Registration is complete:

Set up Departments and Rooms for Facilities	Add Departments and Rooms attached to each department for registered Facilities. This setup can be used to track the devices allocated.
User Management	Add new users
Device Management	trophon2 devices •   Add additional trophon2 devices, assign name, Department and Room Mobile Scanning Devices •   Add additional Mobile Scanning Devices, assign name, Department and Room (the                    Department will be set as a default procedure Department on that particular Mobile                      Scanning Device) Probes •   Ensure all probes have one cycle completed, add probe type, manufacturer name,                     installation date, Department and Room.

 

3.3.1 To begin the Initial Registration

Navigate to www.nanosonicsauditpro.com/registration using your web browser. Select your language and apply cookie options.

•   The AuditPro cloud application website uses cookies to improve user experience, including to remember the               language selection of the user. Accept all cookies or select SHOW DETAILS for more options. (See Cookies               Settings)

Step 1 – Administrator Details

1.1. You will need to register an Administrator for the initial registration. (Other users can be added once set up is               complete.)
1.2. Fill in the fields displayed on your screen (see Figure 16)
1.3. Enter the password twice. Please ensure it meets the password requirements shown on the screen.

 

The email address you enter here will be the one to which all notifications will be sent. Enter only business email addresses. (Note that personal email addresses using public domain are not accepted.)

 

Figure 16: Registration Step 1 – Administrator Details

Step 2 – Verify Your Email Address

2.1. Enter the verification code sent to your email.
2.2. The Resend Code link is to be used if the code has not been entered within 1 hour.

 

Figure 17: Registration Step 2 - Verify Your Email Address

 

Step 3 – Facility Registration details

3.1. Register your Facility details here. The data entered here is critical to the proper functioning of your Nanosonics           AuditPro system.
3.2. The Time zone is used to cross-check all devices, to ensure cycle times and procedure timestamps are accurate         when generating traceability reports.

 

Figure 18: Registration Step 3 – Facility

 

Step 4 – trophon2 information

4.1. In this step you will be registering one or more trophon2 device(s) which must have been prepared according to         the instructions in trophon2 Setup. Best practice is to add all your trophon2 devices at this point.
4.2. Populate the Serial number and IP Address fields.
       Hint. Hover the mouse over the question mark symbol next to each label for instructions how to access this               information on your trophon2 device.
4.3. To register another trophon2 device click Add trophon2 to display a new row of trophon2 data entry fields.

 

Ensure the Facility time, timezone and date match the trophon2 devices, as shown in Figure 19.

 

4.4. Click Validate when finished. Nanosonics AuditPro will check the Serial Number. If any trophon2 devices are not         found in the Nanosonics database, re-enter the correct serial number and continue as above.
4.5. Facility Administrators can add information about the trophon2 devices, such as specify a Department, Room             and a display name. See trophon2 Device details.

 

Figure 19: Registration Step 4 – trophon2 Devices

 

Step 5 – Register Mobile Scanning Devices to Nanosonics AuditPro

In this step you will be registering one or more Mobile Scanning Devices, using the QR code displayed on the screen. This QR code will be saved in the Nanosonics AuditPro Cloud database and will be available for registering new Mobile Scanning Devices (see Register New Mobile Scanning Device).

Optionally, click the Print QR Code button to print the code and save for later Mobile Scanning Device registrations. Best practice is to register all Mobile Scanning Devices now so they can be paired with a trophon2 as necessary in Step 6 – Link trophon2 devices to Mobile Scanning Device.

 

Figure 20: Registration Step 5 – Mobile Scanning Devices

 

To register a Mobile Scanning Device, you will need to perform the following steps below.

5.1. Unlock your Mobile Scanning Device and tap the AuditPro icon to open the application. See Figure 21-1. Select         English as language. Other languages are coming soon. See Figure 21-2.
5.2. Point the Mobile Scanning Device towards the QR code and scan the QR code displayed on the AuditPro Cloud         screen, see Figure 21-3.
5.3. A successful scan will result in your device displaying the screen shown in Figure 21-4. If not, tap the I can’t                find the QR code text for further assistance.
5.4. On the screen shown in Figure 21-4, check carefully that the time and date shown on the Mobile Scanning                 Device is correct. This is a critical step for accurate reporting. It must match the current local date and time. You           will not be able to change the date and time once device registration is complete.

 

Incorrect date or time on the Mobile Scanning Device will severely compromise the accuracy of data in the Nanosonics AuditPro database.

 

5.5. Tap Yes to continue or No to go back to step 5.2 where you can scan the Facility QR code again if you have             scanned an incorrect code.

 

Figure 21: Register Mobile Scanning Device screens

 

5.8. If the information is correct, tap Complete Setup as shown in Figure 21-5 to finish registration using the displayed information. Tap Cancel to go back to the previous screen.
5.9. Once the information is registered in the Nanosonics AuditPro Cloud database, tap Done. Your Mobile Scanning Device has successfully registered to the Nanosonics AuditPro Cloud database. See Figure 21-6. If you have more Mobile Scanning Devices to register, repeat steps 5.2 to 5.8 for each device.
Facility Administrators can add further details for Mobile Scanning Devices, such as specify a Department, Room, enter a display name and add notes. See Mobile Scanning Device details page.
5.10. The final step is to link all previously registered trophon2 devices to a Mobile Scanning Device. Click Next Step in Figure 20 and the screen shown in Figure 22 will appear. Click the X at the top right to proceed.

 

Figure 22: Linking devices

Step 6 – Link trophon2 devices to Mobile Scanning Device

6.1. On each row representing a trophon2 device, click the Mobile Scanning Device arrow to display a list of the serial numbers of previously registered Mobile Scanning Devices. (See Figure 23)
Select one and click Connect to connect the two devices.
Note that not all Mobile Scanning Devices need be connected to a trophon2 device.
6.2. A successful connection will be displayed as shown in Figure 24.
6.3. You have now completed initial registration of your Facility, a Facility Administrator, one or more trophon2 devices and one or more Mobile Scanning Devices. All the trophon2 devices have been linked to a Mobile Scanning Device.

Click Continue to Nanosonics AuditPro™ to open your browser on the Nanosonics AuditPro Home page with Administrator access rights. See Nanosonics AuditPro Cloud Application.

 

Figure 23: Registration Step 6 - Linking trophon2 Devices to Mobile Scanning Device

 

Figure 24: Registration complete

 

It is the responsibility of the Facility to keep Mobile Scanning Devices linked to trophon2 devices charged and always connected to the Facility Wi-Fi. If data is not synced to the Cloud Application in real time as required, procedure notifications and data linking may be inaccurate, compromising system accuracy.

 

Take care of your Mobile Scanning Devices. Procedure data is stored in the Mobile Scanning Device prior to syncing. Should the device be damaged, lost or stolen, any un-synced data may be irretrievably lost, this will permanently compromise the traceability accuracy of data. It is the responsibility of the facility to ensure all devices are connected to the network and system as instructed.

 

3.3.2 Further Registrations

Once the Initial Registration is complete, Administrators can access the Settings menu for further registrations.

Users	Add and manage users
Facility	Add Department and Rooms for registered Facilities.
Register New Facility	Add new Facilities. Only one Facility should be created per physical location. Register New Facility allows an Administrator to register further Facilities in Nanosonics AuditPro, as shown in Figure 18. To add a new Facility, you must perform instructions from Step 3 to Step 6 of Initial Registration, which include adding devices to the Facility and linking them.
Register New trophon2 and Device Linking	Register new trophon2 devices.
Register New Mobile Scanning Device	Register new Mobile Scanning Devices.
Register New Organization	Register an Organization which comprise a number of Facilities.

 

3.3.3 Probe Preparation

1. Prior to first use with AuditPro, reprocess all probes using your registered trophon2 device. (This step will add              probes in the probe list page, see Probe List Tab). Failure to do so will cause an error message on first use of the        probes. See Incorrect Probe Preparation notification.

 

Probe preparation prior to first use is essential to register probe reprocessing events in the Nanosonics AuditPro Cloud database and ensure the accurate hygiene status of these probes prior to their first registered use in Nanosonics AuditPro. Follow the instructions given in [2] on how to complete a trophon2 HLD cycle.

 

2. Facility Administrators can add useful information about the probes such as probe manufacturer, installation date         and condition of probe at installation and other relevant notes in the Probe Information Page. If a probe is not               listed in the probe view, it will need to be reprocessed in your trophon2 device.

 

 

Next: 4 Workflow Overview