Using Butterfly iQ+ Bladder System

This section provides information regarding the Butterfly iQ+ Bladder system. This system provides healthcare providers with a streamlined workflow for bladder scanning applications.

Notes

1. The Butterfly iQ+ Bladder system is not available in all countries.
2. The Butterfly iQ+ Bladder experience requires a dedicated probe (the Butterfly iQ+ Bladder), and it is not compatible with the Butterfly iQ/ iQ+/ iQ3.
3. The Butterfly iQ+ Bladder system is only available on Apple iPads with a USB-C port. See here for a full list of compatible devices.
4. The Butterfly iQ+ Bladder system is limited in depth between 5 cm and 20 cm.

Overview

The Butterfly iQ+ Bladder requires a compatible device and compatible software. It is recommended to always install the latest version of the app. The Butterfly iQ+ Bladder probe is a configuration of the Butterfly iQ+ hardware platform, and thus shares its mechanical and electrical specifications.

Note: The Butterfly iQ+ Bladder does not require a login and does not save images as such no PHI/PII is stored on the device when operating the Butterfly iQ+ Bladder system.

Indications for use

The Butterfly IQ+ Bladder Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging for the measurement of fluid volume of adult patient clinical application for urology.

The ultrasound mode of operation is B-Mode + Auto Bladder Volume (See user manual). The Butterfly Auto Bladder Volume Tool (See user manual) is a software application package.

It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

Contraindications

Not intended for fetal or pediatric use or for use on pregnant patients, patients with ascites, or patients with open skin or wounds in the suprapubic region.

Acquiring a Bladder Volume

1. Make sure the probe is connected to a compatible iPad.
2. Turn on the iPad.
3. Select the Butterfly iQ app; if the Butterfly iQ+ Bladder probe is connected, the system will start loading.
4. Once the system loads you will be presented with a quick tips card. On this screen you will be able to start scanning by tapping on “Start Scanning” or start scanning with tips by tapping on “More help”.
5. On the scan screen you will have a live image which utilizes the Auto Bladder Volume tool for segmenting the bladder. Moreover, you can enable tips on the left side of the screen by tapping on , when the tips are enabled you will be able to scan the bladder alongside useful tips on best practices when it comes to scanning a bladder.
6. Within the live view, you can adjust the depth by swiping your finger up and down on the screen. It is recommended that you center the bladder in the field of view before you start scanning. See also the user manual for the chapter on Auto Bladder Volume.
   
7. Once you find the bladder, you can initiate a measurement either by pressing on “Measure volume” or by pressing on the probe battery button. The app performs a 3D sweep and utilizes the Auto Bladder Volume (See the user manual).
8. Once you acquire a volume, you will be presented with a screen showing the volume, as well as a 3D rendering of the volume for review.
   
9. From the review screen, you can capture up to 3 measurements and use the maximum measurement, or exit to the main screen and start a new scan session. Each of the measurements has a barcode associated with it, which you can scan into an EHR system. The type of code can be configured in the settings menu.
10. Once done, you can exit the scan by tapping on “End Scan” in the top left corner of the screen.
    Note: Once you end the scan, the images will be deleted permanently.

Available Settings

To access the settings menu, tap on the top-right corner (the gear symbol ). Under the settings menu, you can access and adjust the following:

1. My Probe: Access to information about the probe’s serial number, probe’s model, etc.
2. Configure Barcode: Select the type of the barcode which encodes the volume measurement and can be scanned into an EHR system. From the menu you can Enable or Disable the display of the barcode, as well as select one of the following styles for the barcode:
   1. Code 128
   2. Aztec Code
   3. Data Matrix
   4. QR Code
3. Quick start page: configure if the Quick Start Page is displayed each time or if it is skipped upon start up.
4. Auto-freeze: Enable/disable the auto-freeze functionality, if enabled, when the probe detects that it has not been scanning for >30 seconds (e.g. probe scanning in air), it freezes the screen to save the probe’s battery.
5. Contact Support: Contact Butterfly Network’s support team.
6. User manual: Access an e-copy of the user manual.