Signostics uscan User manual

User Manual
P003948
November 2017
www.signosticsmedical.com

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CONTENTS
1. Important Information.................................................................................. 1
About the User Manual .................................................................................. 1
Product Description........................................................................................ 1
Intended uses of Uscan ................................................................................. 3
System and Transducer applications ............................................................. 4
Training .......................................................................................................... 5
Contents of the Uscan packages ................................................................... 6
System Features ............................................................................................ 7
Classifications ................................................................................................ 7
Patient Environment....................................................................................... 8
Cautions, Warnings and Contraindications .................................................... 8
Warnings ................................................................................................... 8
Cautions .................................................................................................. 10
Contraindications..................................................................................... 10
Labeling........................................................................................................ 11
Contact information ...................................................................................... 12
Trademarks and document copyright........................................................... 12
2. Getting Started ........................................................................................... 14
Unpacking the Boxes ................................................................................... 14
Options .................................................................................................... 14
Connecting and disconnecting the Power Supply........................................ 14
Setting up the System .................................................................................. 15
Basic Device Control.................................................................................... 16
Settings ........................................................................................................ 17
Network Printer Setup (Optional) ................................................................. 19
Bluetooth Printer Setup (Optional) ............................................................... 19
Bar Code Scanner Setup (Optional) ............................................................ 19
Imaging Screens .......................................................................................... 20
Ultrasound Scan Screens........................................................................ 20
Recommended ultrasound transmission gel ................................................ 23
Recommended ultrasound probe sterile sheaths......................................... 23
3. Scanning ..................................................................................................... 24
Preparing for the Exam ................................................................................ 24
Default Settings............................................................................................ 24
Ultrasound Scanning.................................................................................... 24
Ultrasound Presets .................................................................................. 24
Ultrasound Scanning ............................................................................... 25
Ultrasound measurement ........................................................................ 25
Ultrasound Movies................................................................................... 26
Bladder Scanning......................................................................................... 26
Measuring Bladder Volume ..................................................................... 26
Audio Feedback....................................................................................... 27
Common Functions ...................................................................................... 27
After Use ...................................................................................................... 28
Turning Uscan off......................................................................................... 28
4. Other Functions ......................................................................................... 29
Annotations .................................................................................................. 29
Text Annotations...................................................................................... 29
Voice Annotations.................................................................................... 29
Exam Notes.................................................................................................. 29
Entering Patient Details................................................................................ 30
Printing ......................................................................................................... 30

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Export........................................................................................................... 31
Scan Review ................................................................................................ 31
Deleting exams and patients........................................................................ 32
Data Security................................................................................................ 32
Setting a Device Password...................................................................... 33
5. Maintenance and Troubleshooting........................................................... 34
Maintenance................................................................................................. 34
Battery Maintenance .................................................................................... 34
Transducer cleaning and disinfection........................................................... 35
Cleaning .................................................................................................. 35
Disinfection .............................................................................................. 35
Troubleshooting ........................................................................................... 36
Clinical Troubleshooting .......................................................................... 36
Signostics Customer Support.................................................................. 36
6. Connectivity And Accessories.................................................................. 37
Accessories.................................................................................................. 37
Power sources ............................................................................................. 37
Internal battery ............................................................................................. 37
Power Supplies (Charger)............................................................................ 37
Mobile Stand Setup...................................................................................... 38
Cleaning .................................................................................................. 39
Disinfection .............................................................................................. 39
7. Specifications............................................................................................. 40
System dimensions ...................................................................................... 40
Environmental Operating and Storage Conditions....................................... 40
Power Supplies (Chargers) .......................................................................... 41
Internal battery ............................................................................................. 41
Measurement accuracy................................................................................ 41
Degree of Protection Against Ingress of Water............................................ 42
8. Safety .......................................................................................................... 43
Ergonomics .................................................................................................. 43
External materials ........................................................................................ 43
Disposal ....................................................................................................... 43
Electrical safety ............................................................................................ 43
Electromagnetic compatibility (EMC) ........................................................... 44
Power Supplies (Chargers) .......................................................................... 46
Biological safety ........................................................................................... 46
Acoustic Output............................................................................................ 46
9. Advanced Device and IT Setup................................................................. 48
Administrator Setup...................................................................................... 48
User Management........................................................................................ 49
Multiple Device Setup .................................................................................. 49
Ultrasound Scanning Restrictions ................................................................ 49
Data Recording Restrictions ........................................................................ 50
Storage Access Restrictions ........................................................................ 50
Device Tracking ........................................................................................... 50
References.................................................................................................. 52
Glossary ....................................................................................................... 53
Index.............................................................................................................. 5

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1. IMPORTANT INFORMATION
About the User Manual
This User Manual is a reference tool for users of the Uscan; it does not constitute medical advice nor provide
clinical training, instruction in exam protocols, or information on how to interpret scans.
This manual should be read before Uscan is used. The Uscan is intended to be used in a medical facility.
Manual conventions
The following style conventions are used in this manual:
Buttons found on your Uscan are indicated in bold italics, e.g., Scan button. This style is also used to
describe areas of the display touch screen, e.g., Image name.
“Tap” refers to touching the screen quickly with your finger.
“Click” refers to pressing and releasing the button on the probe unit.
“Drag” refers to touching the screen with your finger and then moving your finger across the screen.
“Swipe” refers to moving your finger across the screen quickly.
“Pinch” refers to moving two fingers in a pinch motion or pinch release motion across the screen.
“Check” refers to tapping a checkbox to enable the associated function.
“Uncheck” refers to tapping a checkbox to disable the associated function.
“Select” refers to tapping a menu item from a menu list.
New terms that describe functions for the App are introduced in italics, e.g., exam.
Numbered steps must be performed in a specific order.
Bulleted items are lists in no specific order.
Links to other sections within the manual appear colored and underlined, e.g., see Contact information
(page 12).
Version information
This User Manual applies to Uscan with software version V3.5.x
Warnings, Cautions and Contraindications
A Warning describes precautions a user should take to prevent injury or loss of life.
A Caution describes precautions a user should take to prevent damage to the device.
A Contraindication is a specific situation in which the device should not be used because it may be harmful to
the patient.
Warnings, cautions and contraindications are included throughout this manual along with the content to which
they apply. In addition all warnings and cautions are listed in the Cautions, Warnings and Contraindications
(page 8).
Product Description
The Uscan consists of a Uscan display running a Signostics App, connected to a Uscan probe via a cable. The
system has been designed for non-invasive urological imaging examinations, and enables users to non-
invasively perform general abdominal imaging and measurements at the point-of-care. The Uscan generates
and transmits ultrasound energy in the form of pulses in the 3 to 7MHz range into a patient, detects the
reflected pulses, and processes the information in order to generate ultrasound images and measure anatomical
structures.

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The Uscan display is an off-the-shelf Android tablet or phone approved, pre-configured, and supplied by
Signostics. The tablet or phone specifications are at least the following:
Processor with processing performance of a dual core 1.5GHz Cortex-A9;
5 inch diagonal color display with 1200 x 780 pixels;
Touch screen interface;
Internal speakers and microphone;
Fully compliant on-the-go (OTG) or host USB 2.0 port;
Android operating system 5.0 or later;
IEC 60950-1 certification (or IEC 60601-1 certification);
Storage specification of -20°C to 50°C, 10-93% non-condensing relative humidity, and 50-101.5kPa
pressure;
Operating specification of 5°C to 40°C, 15-90% non-condensing relative humidity, and 70-101.5kPa
pressure;
Bluetooth 4.0
IEEE 802.11 a/b/g/n/ac
1GByte SDRAM memory;
16GBytes storage; and
Power, volume up and volume down buttons.
The Uscan display is provided with a power supply. When the Uscan display is connected to the Uscan probe
the combination is configured as a medical electrical system.
The Uscan probe contains a probe assembly (P003992 or P003993) attached to an ultrasound transducer (B3-
5 Transducer, P004200). The transducer shall be referenced in this manual when the patient contact part of the
probe and transducer is being described.
The Uscan enables the user to automatically measure bladder volume with or without a brightness mode (B-
mode) image for guidance (Fig 1.1). The system processes data in real-time, and when the user is not scanning
in the correct location to detect a bladder, the display guides the user to the correct location, reducing
measurement errors.
The user can elect to scan organs beside the bladder, including the kidney and prostate, with controls to change
brightness and depth in this mode.
Images are able to be annotated by using voice or text. Examination notes can be entered.
The Uscan provides optional wireless connectivity allowing remote storage and device tracking.
Accessories for wireless printing, bar code scanning, and a mobile stand are supported and available in some
countries.
The Uscan display and probe are battery powered.