Signostics uscan User Manual

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Page 1

User Manual

P003948

November 2017

www.signosticsmedical.com

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P003948 Uscan User Manual Page | ii

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 noninvasively 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 (B35 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 (Bmode) 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.

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Fig 1.1 System User Interface and Display

Intended uses of Uscan

The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.

The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Contraindications

 The Uscan is designed for percutaneous scanning only. Do not attempt intra-cavity imaging; in partic-

ular, trans-esophageal, trans-vaginal and trans-rectal scans are contraindicated.

 The Uscan is not intended for ophthalmic use or any use causing the acoustic beam to pass through the

eye.

Cautions

 Federal (USA) law restricts this device to sale by or on the order of a physician.

Warning

 Show care when scanning near a wound to avoid damaging or further injuring the affected area.

 Review the ultrasound image when measuring bladder volume on pregnant or post-partum patients,

and adjust the bladder outline if it has included amniotic fluid or the uterus in the measurement.

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System and Transducer applications

Table 1.1 Uscan applications

Clinical Application Mode of Operation

General Specific B-mode

B-mode/ M-mode

B-mode/

PW Doppler

Ophthalmic Ophthalmic

Fetal imaging & oth

Fetal

Abdominal



Intra-operative (specify)

Intra-operative (neuro)

Laparoscopic

Pediatric



Small organ (specify)*



Neonatal cephalic

Adult cephalic

Trans-rectal

Trans-vaginal

Trans-urethral

Trans-oesophageal (non-cardiac)

Musculoskeletal (conventional)



Musculoskeletal (superficial)

Intravascular

Other (specify)

Cardiac

Cardiac adult

Cardiac pediatric

Intravascular (cardiac)

Trans-esophageal (cardiac)

Intra-cardiac

Other (specify)

Peripheral vessel

Other (specify)

* Small organ use is prostate

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Table 1.2 Uscan applications for the B3-5 transducer (P004200)

Clinical Application Mode of Operation

General Specific B-mode

B-mode/ M-mode

B-mode/

PW Doppler

Ophthalmic Ophthalmic

Fetal imaging & oth

Fetal

Abdominal



Intra-operative (specify)

Intra-operative (neuro)

Laparoscopic

Pediatric



Small organ (specify)*



Neonatal cephalic

Adult cephalic

Trans-rectal

Trans-vaginal

Trans-urethral

Trans-esophageal (non-cardiac)

Musculoskeletal (conventional)



Musculoskeletal (superficial)

Intravascular

Other (specify)

Cardiac

Cardiac adult

Cardiac pediatric

Intravascular (cardiac)

Trans-esophageal (cardiac)

Intra-cardiac

Other (specify)

Peripheral vessel

Other (specify)

* Small organ use is prostate

Training

The Uscan device is intended to be used by clinicians with appropriate professional qualifications and clinical training. Intended users include physicians, nurses, nurses' aides, midwives, and physical therapists.

All users should read the generic

ALARA education program supplied with your Uscan (see enclosed ISBN 1-93004 7-71-1, Medical Ultrasound Safety) or the Health Canada “Guidelines for the Safe Use of Diagnostic Ultrasound” available on the Health Canada website. This program outlines the guiding principle for diagnostic ultrasound, where the qualified user keeps ultrasound exposure to “as low as reasonably achievable” while performing a diagnostic examination.

In addition to the above, users in

tending to use the general imaging must have appropriate training in

ultrasound. Appropriate information on training may be obtained by contacting

Signostics or your local

professional body.

For users measuring bladder volume an understa

nding of anatomy and location of the bladder is required.

Ultrasound training is required if bladder outline adjustments are to be performed.

Warning

 Y

ou must have appropriate ultrasound training before using the system for general ultrasound imaging

or adjusting bladder measurement outlines.

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Contents of the Uscan packages

Yo ur Uscan pack contains the Uscan Probe carton with the Uscan probe and accessories, and the Uscan Display carton with an off-the-shelf tablet (or handheld display) pre-loaded with Signostics software.

The Uscan Probe carton contains the following:

 A Uscan probe (with connected transducer);

 2 Quick Reference Guides.

 A Signostics power supply.

 A USB Flash device containing:

 The User Manual.

 Training materials including:

• A generic ALARA education program (see enclosed ISBN 1-93004 7-71-1, Medical Ultrasound Safety).

 Terms and conditions of Warranty.

 Quick Reference and Setup Guides.

The Uscan Display carton contains the following:

 A tablet (or handheld display) preconfigured with the Uscan software;

 A probe connection cable.

 A Signostics power supply.

 A setup guide.

Fig 1.2 Uscan Pack Contents

Uscan Display (tablet shown)

1800mm Probe tablet connection cable (P003968 or P003986)  or 900mm Probe phone connection cable (P003969)

Signostics Power Supply (P003198) and adaptors

Uscan Display Power

Supply (P003198) and

adaptors

Quick Reference

Guides (P003958 and

P004039) and Setup

Guide (P004040)

Ultrasound probe

(P003992 or P003993)

and transducer

(P004200)

USB Flash

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System Features

The front of the Uscan tablet display and probe are shown in Fig 1.3. The Uscan handheld display contains the features in Fig 1.3 except the dock connector but may differ from the layout shown.

Fig 1.3 System Features

1 Audio output/Audio input 8 USB Connector

2 Touch screen 9 Power LED

3 Power On/Off 10 Over-mold

4 Volume Up/Volume Down 11 Transducer

5 Microphone 12 Scan button

6 Speaker 13 Dock Connector

7USB port

Camera for bar code scanning is on the rear of the display.

Classifications

The Uscan is internally battery powered during scanning.

The Signostics Power Supply P003198 classification for Protection against electric shock: Class II equipment.

The B3-5 Sector (P004200) transducer is: Type BF Applied Part.

The Uscan probe is classified as IPX1.

The Uscan is not for use within an oxygen rich environment.

The Uscan is suitable for non-continuous operation (Mode of Operation (page 41)).

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Patient Environment

The Uscan is intended to be used in a medical facility. It is battery powered and the user is expected to bring the system into the patient environment for use. Power supply connections for recharging are to remain outside the patient environment. See

Fig 1.4 for a drawing of the patient environment. When a power supply is

connected, ensure the connection c

an be easily disconnected.

Fig 1.4 Patient Environment

Warning

 Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC

MIXTURE

WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.

 Do not use the system near high-fre

quency surgical equipment, as it could create a burn hazard.

 Do not recharge the system in the patient environment.

Caution

 Do not allow any fluid to enter the USB connector on the probe or

any connectors on the display.

If fluid is spilled on the probe, display

, or cable, immediately remove the fluid with a soft dry cloth. Carefully inspect the probe USB connector and display connectors for signs of fluid ingress. If there are any signs of fluid ingress or if the device exhibits any unusual behavior, do not use and contact

Signostics customer support

or your Signostics distributor immediately. If required, also follow the cleaning and disinfection instructions (see

Cleaning).

Cautions, Warnings and Contraindications

To ensure the device is not damaged and user and patient safety is maintained, please read and follow the cautions and warnings below.

Warnings

 Show care when scanning near a wound to avoid damaging or further injuring the af

fected area.

 You must have appropriate ultrasound training before using the s

ystem for general ultrasound imaging

or adjusting bladder measurement outlines.

 Review the ultrasound image when measuring bla

dder volume on pregnant or post-partum patients,

and adjust the bladder outline if it has included amniotic fluid or the uterus in the measurement.

 Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC

MIXTURE

WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.

 Do not use the system near high-fre

quency surgical equipment, as it could create a burn hazard.

 Do not recharge the system in the patient environment.

 Recharge Uscan o

nly with the Power Supplies (chargers) provided.

 The U

scan Power Supply are dedicated units to be used exclusively with the Uscan System only.

 Only connect the Power Supplies to a mains supply rated at 100-24

0V and 50-60Hz.

Patient Environment Side View

Patient Environment Top View

1.5m 1.5m

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 Do not use the device or Power Supply if there are signs of damage.

 Be aware of latex allergy. Some commercially available transducer covers contain latex. Refer to the

US FDA alert title: “Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”, issued March 29, 1991.

 Check the connecting cable, connectors, and system housings before use for cracks or fraying. Do not

use if damaged.

 No modification of this equipment is allowed.

 This device contains no user-serviceable parts. Please contact Signostics customer support or your

Signostics distributor for maintenance or repair.

 The internal probe battery is not to be replaced by the user – doing so may create fire or explosion

hazard.

 Remove all particles and other matter from crevices and surfaces when cleaning the system and

components.

 The device is supplied unsterile.

 Clean and disinfect the transducer between patients.

 Before cleaning or disinfection turn Uscan off and disconnect from the power supply.

 Do not submerge the probe, the display or the power supply (charger) as electric shock could result.

The ultrasound probe is IPX1 which allows water falling vertically onto the probe. The display is IPX0 and has no protection against ingress of water.

 Clean and disinfect the system before placing in a bag for transport. Use the supplied Signostics probe

holder to store the probe. Clean and disinfect the probe holder regularly.

 After cleaning or disinfection examine the ultrasound probe and display as appropriate for cracks or

leaks, and if damage exists discontinue use of the system and contact

Signostics customer support or

your Signostics distributor.

 The user must not touch the any device connectors while in physical contact with the patient.

 The Uscan probe is connected to the Uscan display running Signostics software to configure a

medical system. The display has been certified by Signostics as part of a medical system to IEC 60601-1: 3rd edition.

 Do not connect the Uscan display to external computers or peripherals using the USB port unless the

system is outside the patient area. Failure to comply with these guidelines may result in electric shock.

 Mounting the Uscan display on a mobile stand is configuring a medical system. Only use the

Signostics provided mobile stand accessory (P004013).

 Only connect accessories that are specified as being compatible with Uscan. Contact Signostics

customer support or your Signostics distributor for information on compatible accessories and systems.

 If required, recharge the Uscan Probe only with the Signostics power supply (charger) provided

(P003198).

 The Uscan power supplies are dedicated units to be used exclusively with the Uscan System only.

 Do not open or modify the Signostics Power Supply P003198 or any other supplied power supplies –

Risk of electric shock

 When using the optional Signostics mobile stand, if a Multiple Socket Outlet is required only use an

outlet and power cable certified to IEC 60601-1, and fix to the stand using a bolt and tool.

 After storage at extreme temperatures, check the transducer surface temperature before applying to a

patient. A cold or hot surface may burn a patient.

 Avoid musculoskeletal strain with prolonged use of Uscan.

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 Do not incinerate or discard the device in general waste at end of life. The lithium battery is a potential

environmental and fire safety hazard.

 Uscan compl

ies with the requirements of IEC 60601-1:3rd Edition. To avoid the risk of injury or

electrical shock, comply with all safety instruction and warnings.

 Uscan compl

ies with the Electromagnetic Compatibility requirements of AS/NZ CISPR 11:2004 and IEC 60601-1-2:2007. However, electronic and mobile communications equipment may transmit electromagnetic energy through air and there is no guarantee that interference will not occur in a particular installation or environment. Interference may result in artifacts, distortion, or degradation of the ultrasound image. If Uscan is found to cause or respond to interference, try re-orienting Uscan or the affected device, or increasing the separation distance between the devices. Contact

Signostics

customer support or your Signostics distributor for further information

 When using the optional mobi

le stand, the Uscan system can be susceptible to ESD and may require

manual intervention. If ESD results in an error, unplug the probe and plug back in to restore operation.

 Neurological use on patients with Creutzfeld-Jacob disease must not be pe

rformed. The device is

unable to be disinfected after such use.

 The ALARA principle (As Low As Reasonably Achievable) should be employed for all medical

ultras

ound exposure

Cautions

 Federal (USA) law restricts this de

vice to sale by or on the order of a physician.

 Ultrasound transducer crystals are

fragile and are easily damaged if knocked, dropped or excessively

vibrated.

 Avoid unnecessary bending or winding of the connecting cable.

 The Uscan

batteries should be charged every six months at a minimum, even if you are not using your

device. When storing for greater than 3 days, store at ambient or cooler temperature.

 Use only recommended disinfection methods.

 Use abrasive cleaners, isopropyl

alcohol or solvents sparingly, and if used immediately clean and

remove residual substances from the Uscan.

 Do not heat sterilize any part of the Us

can device.

 Minimize application of alcohol bas

ed disinfectant to colored overmold materials. Long term use may result in material degradation. If alcohol based disinfectant is applied to the overmold, immediately remove by wiping with a damp cloth.

 Only operate, charge and store Uscan within

the approved environmental parameters.

 Uscan co

ntains sensitive components and circuits. Failure to observe proper static control procedures

may result in damage to the system. Any faults should be reported to

Signostics customer support or

your Signostics distributor for repair.

Contraindications

 The U

scan is designed for percutaneous scanning only. Do not attempt intra-cavity imaging; in

particular, trans-esophageal, trans-vaginal and trans-rectal scans are contraindicated.

 The Usc

an is not intended for ophthalmic use or any use causing the acoustic beam to pass through the

eye.

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Labeling

Symbol Explanation

Manufacturer

Intertek nationally recognized testing laboratory certification mark for Canada and United States

TUV Rheinland nationally recognized testing laboratory certification mark

UL Recognized Component mark certifying compliance with Canadian and United States requirements

Tested to comply with FCC standards

Class II Equipment

Type BF applied part (B – Body, F = floating applied part)

Caution or Warning

Consult instructions for use

Do not dispose of this product in normal trash or landfill (see European Commission Directive 93/86/EEC). Refer to local regulations for disposal

IPX1

Degree of protection from moisture for the ultrasound probe. The probe is protected against effects of vertically falling water

REF

Part Number

Serial number

Date of manufacture

max °C

min °C

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

Stack box this way up

Direct Current (DC)

Alternating Current (AC)

Dangerous voltage

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Contact information

United States



EchoNous Inc.

8310 154th Avenue NE

Building B, Suite 200

Redmond, WA 98052

Technical Support (toll free) 844-502-7094

Sales (toll free) 844-854-0800

[email protected]

Website www.signosticsmedical.com

Trademarks and document copyright

EchoNous®, Uscan®, the EchoNous® Logo and the Uscan® Logo are registered trademarks of EchoNous, Inc. and its subsidiaries in the United States and other countries. Unauthorized use is strictly prohibited.

Mopria

, the Mopria® Logo and the Mopria® Alliance logo are registered trademarks and service marks of

Mopria Alliance, Inc. in the United States and other countries. Unauthorized use is strictly prohibited.

All other trademarks are the property of their respective owners.

Scan button

Rx only

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or any other practitioner licensed by law of the State in which he practices to use or order the device

Symbol Explanation

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2. GETTING STARTED

Unpacking the Boxes

Yo ur Uscan system is shipped in multiple boxes. Be careful not to insert anything sharp through the top of the boxes when opening. Check you have received all of the ordered components:

 A Uscan display (w

ith pre-installed Signostics software), associated power supply, probe connection

cable, protective cover, and setup guide.

 A Uscan p

robe with Signostics power supply, USB Flash drive, and quick reference guide.

Options

 Carry bag with probe holder a

nd protective cover.

 Wireless printer (Citizen Systems Model CMP-20BTU 2" Mobile Printer with Bluetooth).

 Wireless barcode scanner (not available in all countries. Contact

Signostics customer support or your

Signostics distributor for recommended sca

nners).

 Mobile stand (P004013) with Signostics power supply and probe connection cable.

If any parts are missing or damaged then contact

Signostics customer support or your Signostics distributor as

soon as possible.

Connecting and disconnecting the Power Supply

Fig 2.1 Power Supply Connections

(Tablet shown)

You should fully charge the display and probe before using them for the first time (see

Fig 2.1).

Warning

 Recharge Uscan only with the Power Supplies (chargers)

provided.

 The Uscan Power Supply is a dedicated unit to be used

exclusively with the Uscan System only.

 Only connect the Power Supplies to a mains supply rated at

100-240V and 50-60Hz.

 Do not use the device or Power Supply if there are signs of

damage.

Recharge the display using the power supply provided with the dis

play. The connector is magnetic and can

only be connected in one orientation.

The U

scan probe contains an internal rechargeable battery. The probe can be directly charged using the Power

Supply (P003198) as shown in

Fig 2.1. If the probe is connected to the tablet display, and the tablet display is

plugged into its power supply, both the display and ultrasound probe batteries are

recharged together. The

handheld display does not have separate charging and USB ports, so concurrent charging is not possible.

If required, recharge the probe using the Signostics Power Supply

(P003198) (see Fig 2.1). To disconnect all

mains voltages from the equipment remove the display power suppl

y connection and (if applicable) the

probe power supply connection.

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Setting up the System

To setup the system with the optional mobile stand refer to Mobile Stand Setup. To configure the system for mobile use, follow the instructions below (and see Fig 2.2):

1. Press and hold the Power button for 2 seconds to turn the Uscan Display on.

2. The UScan application setup wizard will run. Setup the following:

2.1 Language.

2.2 Date and time.

2.3 Wi-Fi connectivity.

2.4 Registration information.

3. Insert the display into the cover.

4. Insert the USB cable into the display.

5. Secure the cable in the provide cable clip (tablet only).

6. Insert the other end of the cable into the Uscan probe.

7. Connect the provided display charger to the display and fully charge the system.

Fig 2.2 Display setup

After setup, the Uscan Home screen is displayed (see Fig 2.3) and the device is ready to use with default settings. The default settings are appropriate where there is a single user of the system and patient data is not saved to remote servers. The system can be further customized by setting preferences (see

Preference

SetupSettings).

1 2 3

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Basic Device Control

The Uscan communicates with the user in a number of ways.

 Menus

 Screens and windows

 Message boxes

 Icons

Navigate by using the touch screen, using common control gestures such as tap, drag, pinch, spread, and swipe.

The system controls and status are shown in

Fig 2.3.

Fig 2.3 Uscan Home Screen

System Controls

Three system controls are always avail

able at the bottom of the screen:



Back – tap to return to a previous screen.

 Hide –

shown when a keyboard is active. Tap to hide a keyboard.



Home – tap to return to the Home screen.



Tasks – tap to display background tasks (this should not be used except by administrators or

service staff).

System Status Icons

System status icons are shown at the top right of the sc

reen:



Tablet (or phone) battery status.



Wi-Fi status.



Bluetooth status (used for wireless printing and bar code scanning).



Location services – The device GPS is active and transmitting.

System Status

Uscan Menu

Bladder scan instruction video

Exam review (not shown in all configurations)

Show Background Ta sk s

System Notifications

Initiate ultrasound

scan (not shown in all

configurations)

Initiate bladder

measurement

Back

Home

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P003948 Uscan User Manual Page | 17

System Notification Icons

System notification icons are shown at t

he top left of the screen:



Probe battery status.



Remote storage upload notification.



Uscan software update notification (not for Japan).

 The remote Device Manager has located the device.

Uscan Men

Tap

to go to the Uscan menu. The following menu items are available:

 Settings – provide

s access to all Uscan application and tablet system settings.



 About – displays the

software version number and license keys.

Settings

To setup or change Uscan preferences or tablet system settings, tap from the Home screen and select Settings.

The following preferences can be configured:

 Exam Data Storage – ta

p to see storage preference

 Local Storage – check to automatically store patients and images on the tablet (or phone)

internal storage.

 Remote Storage – check to automatically store patients and images to a remote server.

 Remote Server – Select the type of remote server. Options will only be displayed if

the applicable license has been purchased and installed (see Advanced Device and

IT Setup).

 Patient Data – select the source for patient lists (see Advanced Device and IT Setup

 Exam Patient Details – check to force users to enter patient information before starting a

scan.

 Send Anonymized Data to Signostics – check to send anonymized images to Signostics to

enable future product improvements. Check with your institution’s data policies or legal department before enabling this option.

 Send data over metered connection - check to allow data to be sent when connected to a

metered (cellular) connection.

 Organization – tap to update registration details including organization name and address. These

details are transferred to Signostics when a network connection is available.

 Printing

– select the Printer Type to None, Network Printer (see Network Printer Setup (Optional)), or

Bluetooth Mobile Printer (see

Bluetooth Printer Setup (Optional)).

 Display – tap

to see display preferences

 Sh

ow Organization and Transducer Frequency - check to display the Organization and

transducer center frequency on the ultrasound image.

 Ruler – check to display a cm ruler down the left side of the ultrasound screen.

 Show Ultrasound Button – uncheck to remove quick access to ultrasound scans from the

Home screen.

 Show Bladder Image by Default – determines whether the ultrasound image is initially

visible when bladder scans are performed.

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P003948 Uscan User Manual Page | 18

 Clinical – tap to see clinical preferences

 Default Patient Type – tap to change the default patient type (Normal, Pediatric, Deep,

Pregnant, Phantom, “Use last selected value”, or “Ask each time”).

 Strict Probe Positioning Rules - check to prevent fanning for bladder scans unless the bladder

or pubic bone is detected.

 Administration – Refer to Advanced Device and IT Setup section for advanced user management and

setting up several devices with the same preferences.

 Maintenance – provides maintenance related functionality including access to software updates.

 System Settings – provides access to tablet system settings, including Wi-Fi, Bluetooth, Display

settings, Location services, linked Accounts for device tracking, Language, and Date & time.

Page 21

Fig 2.4 Bluetooth Pairing

Fig 2.5 Bluetooth Printer setup

Fig 2.4 Printer Type

P003948 Uscan User Manual Page | 19

Network Printer Setup (Optional)

Network printing enables the Mopria Print Service. The Mopria Print Service enables printing to Mopria certified multifunction printers from many manufacturers which are on a connected WiFi network (see

www.mopria.org).

Follow the instructions below to setup network printing:

 Tap

Uscan menu and select Settings.

 Tap S

ystem Settings.

 Scroll down and tap Pri

nting.

 Tap Mopria Print

Service.

 Slide the on-screen button

to the right to turn

Mopria Printing on.

 Tap Home

to return to Uscan Home screen.

 Tap

Uscan menu and select Settings.

 Tap P

rinting.

 Tap P

rinter Type and select Network Printing.

 Tap Home

to return to Uscan Home screen.

 A printer icon will be shown on all bladder and

ultras

ound images when Network Printing is

selected.

Bluetooth Printer Setup (Optional)

An optional Bluetooth printer is available. Turn the wireless printer on and then follow the instructions below to setup the printer:

 From the Home

screen tap Uscan menu and

select S

ettings. Tap System Settings. Tap

Bluetooth.

 Slide the on-screen button

to the right to turn

Bluetooth on.

 Select Mobile Printer to pair it wi

th the system

(see

Fig 2.4).

 Tap Home

to return to Uscan Home screen.

 Tap

Uscan menu and select Settings.

 Tap P

rinting. Tap Printer Type and select Bluetooth Mobile Printer. Tap Bluetooth Printer.

 Select the paired printer from the list (see

Fig 2.5).

 Tap Home

to return to Uscan Home screen.

Bar Code Scanner Setup (Optional)

An optional wireless bar code scanner is supported in some countries. Bar code scanning using the device camera is also supported. To setup the wireless bar code scanner turn the bar code scanner on and follow the instructions below:

 From the Home

screen tap Uscan menu, select Settings, and select System Settings.

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P003948 Uscan User Manual Page | 20

 Tap Bluetooth.

 Slide the on-screen button to the right

to turn Bluetooth on.

 Select the bar code scanner to pair it with the system.

 Tap Home

to return to Uscan Home screen.

Imaging Screens

Ultrasound Scan Screens

Tap Ultrasound on the Home sc

reen to start an ultrasound exam. See Fig 2.6 for ultrasound screen layouts.

Fig 2.6 Ultrasound Scan Screens

The ultrasound screen layouts contain the following areas:

 Patient Details –

displays patient details for the current exam.

 Preset Used – dis

plays the scan preset used for the current image.

 Image Text Annotation – displays the text annot

ation for the image.

 Image Date and Time – displays the date

and time of the image.

 Gain and Depth Controls – adjust the

gain (brightness) or the depth for the system.

Scan Preset Menu



Exam Icons

Scan Preset Menu

Measurement Area

Ultrasound Image area



Ultrasound Image Thumbnail Region

Patient Details

Image Gain

(brightness) and

Depth

Done (End Exam)

Freeze (Unfreeze)

Patient Details

Preset Used

Image Text

Annotation

Orientation Mark

Image Date and

Time

Done (End Exam)

Freeze (Unfreeze)

Page 23

P003948 Uscan User Manual Page | 21

 Orientation Mark – corresponds to the Scan button orientation on the probe.

 Done – tap to end and save the exam.

 Scan (Stop) – tap to start (unfreeze) and stop (freeze) scans.

 Exam Icons – are displayed depending on the context of the exam. Icons include help, print, measure,

movie, delete, and a menu to access other functions (Annotations, Notes). Tap to activate the function associated with the icon.

 Scan Preset Menu – tap to change to a different scan preset.

 Measurement Area – area for displaying caliper measurements.

 Ultrasound Image – area for displaying ultrasound images.

 Image Thumbnails – will be displayed for multiple images in an exam. Tap a thumbnail to view an

image.

Page 24

P003948 Uscan User Manual Page | 22

Bladder Scan Screens

Tap Bladder Scan on the Home screen to start a bladder measurement. See Fig 2.7 for bladder screen layouts.

Fig 2.7 Bladder Scan Screens

The bladder screen layouts contain the following areas:

 Patient Type – tap to change the patient type (Normal, pediatric, deep, pregnant, phantom).

 Patient Details – displays patient details for the current exam.

 Instructions – instructions of current step required for bladder measurement.

 Instruction animation – animation of current step required for bladder measurement.

 Done – tap to end and save the exam.

 Scan (Stop) – tap to start (unfreeze) and stop (freeze) scans.

 Orientation Mark – corresponds to the Scan button orientation on the probe.

 Measured Volume – measured volume in milliliters.

 Image Text Annotation – displays the text annotation for the image.

 Image Date and Time – displays the date and time of the image.

Exam Icons

Hide/Unhide

Scan Preset Menu

Bladder Outline

Ultrasound Image

Ultrasound Image Thumbnail Region

Patient Type

Patient Details

Instructions

Instruction

Animation

Done (End Exam)

Freeze (Unfreeze)

Orientation Mark

Measured Volume

Image Text

Annotation

Image Date and

Time

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P003948 Uscan User Manual Page | 23

 Exam Icons – are displayed depending on the context of the exam. Tap to activate the function

associated with the icon.

 Hide/Unhide – hide or unhide the ultrasound image area.

 Scan Preset Menu – tap to change from bladder scan to an ultrasound scan preset.

 Ultrasound Image – area for displaying ultrasound images.

 Image Thumbnails – will be displayed for multiple images in an exam. Tap a thumbnail to view an

image.

Recommended ultrasound transmission gel

Signostics recommends the use of Aquasonic 100 Ultrasound Transmission Gel manufactured by Parker Laboratories, INC. Fairfield, New Jersey 07004.

Recommended ultrasound probe sterile sheaths

Where fluid contamination is possible, the ultrasound probe shall be covered with an appropriate sterile sheath, which will promote asepsis and minimize cleaning. Refer to

Signostics website for a list of compatible probe

covers in your country.

Warning

 Be aware of latex allergy. Some commercially available transducer covers contain latex. Refer to the

US FDA alert title: “Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”, issued March 29, 1991.

Page 26

P003948 Uscan User Manual Page | 24

3. SCANNING

Warning

 Check the connecting cable, connectors, and system housings before use for cracks or fraying. Do not

use if damaged.

 Do not connect to the Power Supplies and AC outlets when the system is in the patient environment.

Preparing for the Exam

Before scanning, check you have access to everything you need and the device is ready to scan as follows:

 The sy

stem is powered on and has battery charge available to scan (the probes LED is flashing green

and the display battery icons shows charge).

 The U

scan transducer has been cleaned or disinfected as appropriate (See Transducer cleaning and

disinfection).

 You have suitable ultrasound transmission gel available.

 The patient is positioned appropriately in a supine position.

Default Settings

Press the Power button to power up the system. Adjustable settings cannot increase acoustic output, ensuring the device always operates within safe acoustic output levels. The Home screen appears when the device is on (Fig

3.1), with four tiles:



Fig 3.1 Home Screen

Tap Ultrasound to perform an examination, with the default an abdominal scan. This option is

not available when the Uscan Settings “Show Ultrasound button on home screen” is unchecked.

 Tap Blad

der Scan to perform an examination, with the

default a bladder volume measurement.

 Tap New T

o This? to view a help video.

 Tap Sc

an Review to review locally stored examinations.

This option is not available if Local Storage is not enabled during

Preference SetupSettings.

Ultrasound Scanning

Fig 3.2 Selecting Presets

Tap Ultrasound on the Home screen (see Fig 3.1) to initiate an ultrasound scan.

Ultrasound Presets

Tap th e Scan Preset

Menu (Fig 3.2) to change the preset.

The scan presets are customized ultrasound settings for each clinical application.

Page 27

Fig 3.3 Ultrasound Scanning

P003948 Uscan User Manual Page | 25

Ultrasound Scanning

The probe Scan butt

on corresponds to the Orientation

Icon

on the display. The convention is for the Scan button

to be on the patient's right for transverse scans, and

toward the head for sagittal

or coronal scans. Tap the Scan

button

to start (unfreeze) and stop (freeze) ultrasound

scans. The image automatically generated is a sec

tor or pie

shape of approximately 120º (see Fig

3.3).

Controls for changing gain (brightness) and depth are pro

vided (Fig

3.3).

Fig 3.4 Distance Measurement

Tapping the symbol increases the gain or depth. Tapping the

symbol decreases the gain or depth.

Use a two finger pinch to zoom in or out of images.

Ultrasound measurement

Tap th e

Measurement icon to insert calipers, arrows, or

volume measurements on images:

 Calipers measure a straight line

distance between two

points.

 Arrows highlight part of the image, but do not perform a

asurement.



Fig 3.5 Arrow

Volume Measurements measure an ellipsoid volume using 3 caliper measurements (longitudinal, transverse, and anteroposterior) a

cross two images (see Fig

3.6).

The longitudinal and transverse measurements are positioned on t

he first image, and the anteroposterior measurement positioned on the second image. The first and second images must be orthogonal.

Move the caliper or arrow using the:



Circular handle to position each end of the caliper in

the correct place.



Square handle in the middle to move the entire

caliper around the screen.



Double-arrow handle to rotate the caliper around its

Fig 3.6 Volume Measurement

middle.

You can insert four measurements per image. Tap the image outside t

he shape to end editing that shape. Tap a shape to re-

select it for editing.

The units of measurement are cm for distance and cc for volume.

Page 28

P003948 Uscan User Manual Page | 26

Ultrasound Movies

Fig 3.7 Saved Movie Clip

Tap th e Movie icon to save up to eight seconds of the ultrasound scan as a movie clip.

 The movie clip is saved with

a movie icon in the

bottom left of the image area.

 Tap the movie icon

on the image to show the movie

controls.

 Scroll through image frames by dragging the progress

marker

 Tap

and to pause and play the movie clip.

 Tap th e Save Movie ic

on to save the currently displayed image frame.

 Tap anywhere on the image to hide the movie c

ontrols.

Fig 3.8 Apply gel

Bladder Scanning

Measuring Bladder Volume

On the Home

screen, tap Bladder Scan to start an exam. To

measure bladder volume follow the steps below:

 The default patient is displayed as an icon. To change

tap the icon and select the appropriate patient type (Normal, Pediatri

c, Deep, Pregnant, or Phantom).

 Palpate the pubic bone, and plac

e a generous volume of gel approximately 1 inch (3 cm) above the pubic bone (between the pubic bone and umbilicus) (see Fig

3.8).



Fig 3.9 Place transducer and start scan

Place the probe on the patient mid-line 1 inch above the pubic bone, with the Scan

button directed to the patients head, and angled so the transducer points slightly

towards the patient's feet. Tap the Scan

icon

or click the probe Scan butto

n to start the

measurement.

 If the probe is incorrectly positioned, the display will

pro

mpt the user to move the probe (Fig

3.10). If

required, move the probe up or d

own as instructed by

sliding it along the midline of the body with the Scan

button

always towards the patient's head.



Fig 3.10 Transducer Positioning

When the system detects the probe is in the correct position, the display will prompt the user to fan the p

robe left and right to acquire the three dimensional

bladder data (Fig

3.11). The fan is started by tilting the

probe left or right by up to 45 degrees from vertical, and then

tilting back in the other direction to the other side to approximately 45 degrees from vertical as shown in

Fig

3.11 allowing the ultrasound beam to scan the full

extent of the bladder. When fanning consider the following:

 Do not allow the transducer to slip across the

patient's skin.

Page 29

P003948 Uscan User Manual Page | 27

 Do not fan too fast. As a guideline a complete

fan should take around 3- 5 seconds.

 Do not twist the transducer.

 Angle the probe so the bladder is in the middle

of the ultrasound image.

 During acquisition, the display will show the fan

position.

When the three dimensional data acquisition is complete, the system automatically completes the scan and displays the measured volume (Fig

3.12).

A movie of the complete bladder acquisition i

s displayed.

Bladder Measurement Correction

Correct errors outlining the bladder as follows:

 Tap th e Pencil icon (

) to start outline editing.

 Tap th e Pencil Redraw icon (

) to delete the existing

outline and redraw; or

 Touch the bladder outline t

o adjust the existing outline. A drag circle will appear. Drag the outline to align with the bladder wall. Adjusted outlines change color to blue (see Fig

3.13).



Fig 3.13 Adjusting outline

For fine adjustments, zoom in to enlarge the image then adjust the outline.

 Tap the Pl

ay icon or drag the progress marker to

check other images. Every ima

ge in a measurement can

be adjusted if required.

 If a bladder has been outlined where no bl

adder is

present, then drag the progress marker

to the end of

the bladder, tap

and select Mark Bladder End.

 Tap En

d Editing to finish.

Audio Feedback

The U

scan provides audio feedback during bladder measurement as follows:

 A short double beep sounds when the system has detec

ted a bladder and the user can start the fan of

the probe

 A buzzer sounds if a user starts fann

ing the probe before the system has found the bladder

 A chime sounds when the system expects the user to change direction

of the fan

 A beep sounds at the completion of a

successful scan

 A decaying tone sounds at the comple

tion of a 0ml scan

Common Functions

Multiple Scans

Simply tap the Scan

icon or click the probe Scan button to add more bladder volume measurements

or ultrasound scans to the exam.

Fig 3.11 Acquire data

Fig 3.12 Measured volume

Page 30

P003948 Uscan User Manual Page | 28

Image thumbnails are displayed at the bottom of the image area when multiple scans have been performed. A small movie icon is embedded in movie thumbnails.

Tap a thumbnail to view an image or swipe right to left across the image area to move to the next image.

Deleting Images

Tap th e De

lete icon to delete the displayed image.

Ending/Saving Exams

Tap Do

ne to end the exam. The system will automatically save the exam to local or remote storage if enabled

(see

Preference SetupSettings). A remote storage icon is displayed next to Done when remote storage is

enabled. The user is prompted to ente

r patient details (see Entering Patient Details) if not already entered.

After Use

After each use and between each patient, the probe and transducer must be cleaned and disinfected properly following the steps in this user manual (see

Transducer cleaning and disinfection).

Turning Uscan off

Hold down the Power button of the Uscan display to turn Uscan off.

Page 31

P003948 Uscan User Manual Page | 29

4. OTHER FUNCTIONS

Fig 4.1 Annotating

Annotations

Annotations can be added to individual images.

 Tap the icon

to display the Exam menu.

 Select An

notation from the drop down list (Fig 4.1).

 Select from the predefined set of annotations, or

sele

ct text or voice annotation for custom

annotations (Fig

4.2).

Annotations are applied to individual images.

Text Annotations

Select T

ext Annotation to e

Fig 4.2 Annotation list

nter custom annotations using

the on-screen keyboard.

Voice Annotations

Select V

oice annotation to save a recorded message with an

image. The voice recording controls are displayed.

Press the Microphone icon to record. Speak clearly into the U

scan microphone. Press the Stop icon to end

recording. The length of the recording is displayed. Press the

Microphone icon again to add to the end of

the voice recordings.

Press the

Play button to play a voice recording.

Images with linked voice recordings wil

l display a Voice Annotation icon in the bottom left corner of the

image. Tap this icon to launch the V

oice Annotation window and play the existing voice annotation.

Press the

Delete icon to delete the recording.

Fig 4.3 Exam notes

Exam Notes

Notes can be added for an examination.

 Tap th e

icon to display the Exam menu.

 Select Exam Notes from the drop down list

(Fig

4.1).

 Use the on-screen keyboard to type notes in the text

 Tap th e Microphone icon to use speech recognition

to enter notes (only available wi

th Wi-Fi).

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P003948 Uscan User Manual Page | 30

Entering Patient Details

Patient details will be required if data is saved. Patients may already be stored in the system or they may need to be entered.

Fig 4.4 Entering Patient Details

The source for patient names is a preference setting (see Preference SetupSettings), and may be local storage or a remote server.

The list of patients is displayed under the Existing Patients tab.

Tap the patient name to select a from the list. When querying patients from a remote server you may need to type a few letters into the search field to display patients.

The Search

field can be used to find an existing patient.

Tap th e Bar-code

icon or use a bar-code scanner to search using a patients bar-code.

Tap th e Skip icon to bypass patient data e

ntry. Note: you will be prompted to enter patient details again when

saving the exam.

Tap th e New Patient t

ab to enter the details for a new patient using the on-screen keyboard.

Printing

Tap the Printer icon to print to a Network (see Network Printer Setup (Optional)) or Bluetooth printer (see

Bluetooth Printer Setup (Optional)).

Fig 4.5 Network Printing

Network printing uses a Mopria service (see www.mopria.org) enabling printing to thousands of ne

twork printer types. The Uscan needs to be connected

via WiFi to the same network as the printer. To print:

 Tap th e

icon.

 Tap PR

INT ALL to print all scans, or PRINT

SELECTION to print only selected scans.

 Select the printer from the drop down list.

 If required, adjust number of copies, paper size,

colo

ur, orientation, or any other options provided

by the printer.

 Tap th e

icon to send to the printer.

Bar code Entry

Skip

New Patient Tab

Search for Patient

Existing Patient

Ta b

Patient List

Page 33

P003948 Uscan User Manual Page | 31

 Bluetooth printing only prints the current image.

Export

Images, movie clips, and pdf reports can be exported to the displays internal storage for later download to a computer via USB.

 Tap the icon

to display the Exam menu.

 Select Export from t

he drop down list.

 Select Image/Video or PDF Repo

rt from the drop down list.

 Tap EXPORT ALL to export a

ll scans, or EXPORT SELECTION to export only selected scans.

The Images, Videos, or PDF Report are saved to the displays internal storage

in a sub-folder of “Uscan Export”. The sub-folder is named using the patient name, date, and time of the exam (PatientName YYYYMMDD_HHMMSS).

Scan Review

Scan Review is available when local storage is enabled. Tap the Scan Review icon on the Home screen to review saved examinations in local storage.

Fig 4.6 Scan Review

The data is arranged under patients, with each patient being able to link one or more examinations, and each examination containing one or more images and/or movies (an image/movie may be a bladder volume measurement or an ultrasound scan of another organ).

A list of patients will be displayed. Tap the patient to display

the list of exams attached to that patient. To view

all exams, tap the Vie w by Exam tab.

Skip

Exam Tab

Search for Patient

Patient Tab

Patient List

Page 34

P003948 Uscan User Manual Page | 32

Fig 4.7 Relationship between patients, exams and images

Use the search function to find a patient and associated exams. Tap the patient arrow to view all exams associated with a patient. Tap the e

xam to open and review the images.

Fig 4.8 Deleting Patients

Deleting exams and patients

To delete an exam or a patient from local storage tap Scan Review Mode on the Home screen. Tap and hold the exam

or patient. The exam or patient will be checked, and check boxes appear next to other patients and exams (see Fig

4.8).

Tap other patient and exam checkboxes as required, and then tap the T

rash can icon

at the top right of the screen to

delete all checked exams and patients.

Alternatively, use the menu by tapping the

icon. The

following menu option

s are available:

 Use Delete patients without exams to de

lete any

patients with no associated exams.

 Use Delete All to delete al

l but the open exam(s).

 Use Delete Oldest to cre

ate space on the local storage. At least 10% of the oldest exams are deleted.

Data Security

Data security is embedded in the system as follows:

 The system can be locked by a pin or pass

word. No user will be able to access any data on the system

without access to the pin or password.

 All data saved on the system is encryp

ted using FIPS 140-2 Certified VPN (256-bit encryption), 256HW-accelerated encryption for Data-at-Rest (DAR). Where the system has been stolen, no data will be accessible without the pin or password.

 Secure Wi-Fi protocols are support

ed, enabling data to be securely saved to remote storage, with no

local storage of patient data.

 No internet ports are open. In the e

vent a third party is able to access the system, they will not be able

to access any data without the pin or password.

 No third party applications are able to be installed or run on the system, preventing malware

and

virus’s.

Tablet Storage

Patient A

Patient B

Patient C

Exam 1

Exam 2

Exam 3

Exam 1

Exam 2

Image 1

Image 2

Movie 1

Page 35

P003948 Uscan User Manual Page | 33

Setting a Device Password

To set a device pin or pass

word as follows:

1. From the Home

screen tap Uscan menu, tap Settings, and select System Settings.

2. Select Security

3. Tap Screen lock

4. Select Pin

or Password .

5. Enter the pin or password.

6. Tap Continue

7. Confirm the pin or password.

8. Tap OK

9. Select your notification content prefe

rence.

10. Tap Home

to return to Uscan Home screen.

Page 36

P003948 Uscan User Manual Page | 34

5. MAINTENANCE AND TROUBLESHOOTING

Maintenance

Warning

 No modification of this equipment is allowed.

 This device contains no user-serviceable parts. Please contact Signostics

customer support or your

Signostics distributor for maintenance or repair.

 The internal probe battery is not to be replaced by the user - doing so may create fire or explosion

hazard.

Uscan requires no routine or periodic maintenance on either hardware or software components.

Inspect the transducer and display unit housings, connectors and cables prior to each use for cracks; if cracks are found, use of the device should be discontinued immediately. Contact

Signostics Customer Support or your

Signostics distributor to arrange repair or replacement.

If Uscan behaves in an abnormal manner or when damage is suspected use of the device should be discontinued immediately. Contact

Signostics Customer Support or your Signostics distributor to arrange

repair or replacement.

Uscan must be returned to Signostics Customer Support or your Signostics distributor to arrange battery replacement. If you plan to dispose of the Uscan, recycle batteries where possible and abide by local disposal guidelines and directives.

Caution

 Ultrasound transducer crystals are fragile and are easily damaged if knocked, dropped or excessively

vibrated.

 Avoid unnecessary bending or winding of the connecting cable.

If Uscan is dropped or suffers a heavy knock

 Inspect the device. If you discover major damage do not use the device; report the fault to your Uscan

distributor for repair.

 Switch on and check normal function of all controls.

 Tap Home Menu, and select Maintenance and Probe Calibration to check the probe inertial sensors.

If there are any concerns about operation of the device, report the faults to your Uscan distributor for inspection and/or repair.

Battery Maintenance

The Uscan batteries cannot be removed by the user. Precautions need to be taken if the device is not used for long periods of time. Before storage, fully charge the device. Turn the device off when placing in storage, and store at ambient or cooler temperature. Take the device out of storage at least every six months and recharge the device.

Caution

 The Uscan batteries should be charged every six months at a minimum, even if you are not using your

device. When storing for greater than 3 days, store at ambient or cooler temperature.

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P003948 Uscan User Manual Page | 35

Transducer cleaning and disinfection

Warning

 Remove all particles and other matter from crevices and surfaces when cleaning the system and

components.

 The device is supplied unsterile.

 Clean and disinfect the transducer between patients

 Before cleaning or disinfection turn Uscan off and disconnect from the power supply

 Do not submerge the probe, the display unit or the power supply (charger) as electric shock could

result. The ultrasound probe is IPX1 which allows water falling vertically onto the probe. The display may have no protection against ingress of water. Refer to the display user manual.

 Clean and disinfect the system before placing in a bag for transport. Use the supplied Signostics probe

holder to store the probe. Clean and disinfect the probe holder regularly.

Caution

 Use only recommended disinfection methods

 Use abrasive cleaners, isopropyl alcohol or solvents sparingly, and if used immediately clean and

remove residual substances from the Uscan.

 Do not heat sterilize any part of the Uscan device.

Cleaning

Signostics recommends the use of a soft cloth, lightly dampened with warm water or a mild soap solution for cleaning the probe and transducer. Wipe surfaces with the moist cloth, and towel dry with a soft clean cloth.

For cleaning requirements of the display refer to its user manual.

Disinfection

The following disinfecting means can be used with the Uscan:

 T-Spray II by Pharmaceutical Innovations of New Jersey

 Sani-Cloth® Active by PDI of Flint, UK

 Tuffie 5 Wipes by VernaCare of Lancashire, UK

 Protex Disinfectant Wipes by Parker Laboratories of New Jersey

 Any Isopropyl alcohol impregnated wipes with <= 70% w/w alcohol

Refer to Signostics website for additional disinfection options.

Caution

 Minimize application of alcohol based disinfectant to colored overmold materials. Long term use may

result in material degradation. If alcohol based disinfectant is applied to the overmold, immediately remove by wiping with a damp cloth.

The ultrasound probe and transducer may be disinfected using a wipe or spray method of disinfection. First clean the ultrasound probe and transducer as above. Then wipe or spray the probe and transducer with disinfectant, and leave for the disinfectant manufacturers recommended contact time. Remove any residue with a soft cloth moistened with water. Do not allow any solutions to dry on the probe and transducer.

Warning

 After cleaning or disinfection examine the ultrasound probe and display as appropriate for cracks or

leaks, and if damage exists discontinue use of the system and contact Signostics

customer support or

your Signostics distributor.

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P003948 Uscan User Manual Page | 36

Troubleshooting

Table 5.1 Troubleshooting guide

Symptom Possible cause Remedy

The Usca

n does not turn on Flat battery Connect to the display charger and turn on.

The Usca

n displays a “Probe

Error” message when starting a scan or during scanning

Transducer fault.  Low Probe battery.

Unplug the USB connector from the probe, wait 10 seconds, and reconnect. Check the battery status and connect the dis

play unit to the display power supply (charger) if the display or probe battery is low. If probe is still not recognized, unpl

ug the probe and connect directly to the Signostics power supply (P003198) and leave for 2 hours to charge.

The Usca

n battery fails to recharge after a period of heavy use. The battery status indicates batteries are not recharging despite the system being connected to a power supply (charger)

Battery temperature exceeds 45ºC

Allow device to cool for 10 - 15 minut

es, then try charging the

battery again.

Uscan becomes non-res

ponsive or will not power up after recharge.

Unknown system error

Shutdown Us

can and reboot.

Any error message not r

esolved by the actions above or the action suggested on screen.

Various errors

Error messages generated by the s

ystem will be accompanied by a description of the error or an error code. If unresolved, contact

Signostics customer support or your distributor with

the message and code.

Clinical Troubleshooting

Fig 5.1 Scan Technique

Light downward pressure Firm downward pressure

Bladder off center Bladder centered





Scan technique impacts the quality of the ultrasound image during a bladder measurement, and therefore impacts the accuracy of the measurement. The following tips assist in producing reliable and repeatable measurements:

 Move and angle the probe so the center of the

ladder is in the center of the ultrasound image

 Apply moderate downward pressure. On large

pati

ents, apply firm downward pressure

 Fan the probe at a smooth speed, aiming to

complete the

measurement in less than five seconds

 Pivot and do not slip or slide t

he tip of the probe

Signostics Customer Support

If problems persist or recur, contact

Signostics Customer

Support or your Signostics distributor.

For other countries, refer to Signostics website (see

Contact information page 12).

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P003948 Uscan User Manual Page | 37

6. CONNECTIVITY AND ACCESSORIES

Accessories

The following accessories are supported by Uscan:

 Wireless printer

 Wireless bar code scanner

 Signostics mobile stand (P004013)

 Signostics Power Supply (P003198)

 System connectivity

Warning

 The user must not touch the any device connectors while in physical contact with the patient.

 The Uscan probe is connected to an Android display running Signostics software to configure a

medical system. The Android display must be certified to the respective IEC standards and particular national deviations (IEC 60950 or IEC 60601-1:2nd and/or 3rd edition).

 Do not connect the Uscan display to external computers or peripherals using the USB port unless the

system is outside the patient area. Failure to comply with these guidelines may result in electric shock.

 Mounting the Uscan display on a mobile stand is configuring a medical system. Only use the

Signostics provided mobile stand accessory (P004013).

 Only connect accessories or items that are specified as being compatible with Uscan. Contact

Signostics

customer support or your Signostics distributor for information on compatible accessories

and systems.

 When using the optional Signostics mobile stand, if a Multiple Socket Outlet is required only use an

outlet and power cable certified to IEC 60601-1, and fix to the stand using a bolt and tool.

Power sources

During operation, Uscan is electrically powered by an internal battery. The battery can be recharged by a mains-powered supply via the provided power supplies (chargers).

Internal battery

The Uscan displays and the Uscan probe contain internal batteries.

When powered by a fully charged battery, Uscan will run for more than 12 hours with an average operating regime of 4 x 1 minute scans per hour.

From a fully discharged state, while Uscan is in sleep mode, the battery recharges to 80% capacity when connected to a display power supply (charger) for 3 hours.

Power Supplies (Charger)

Warning

 Recharge Uscan only with the power supplies (chargers) provided.

 If required, recharge the Uscan Probe only with the Signostics power supply (charger) provided

(P003198).

 The Uscan power supplies are dedicated units to be used exclusively with the Uscan System only.

 Do not open or modify the Signostics Power Supply P003198 or any other supplied power supplies -

Risk of electric shock

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P003948 Uscan User Manual Page | 38

 Only connect to an AC supply rated at 100-240V and 50-60Hz.

 Do not use the device or power supplies (chargers) if there are signs of damage.

The Signostics power supply (P003198) delivers a charging power to the Uscan Probe of between 0-10W.

From a fully discharged state, full charge of the probe will take approximately 2-3 hours.

Mobile Stand Setup

An optional mobile stand is available (P004013). The mobile stand has a mounting dock for a tablet display, a mount for an optional wireless printer, a probe holder, a gel holder, a flat work surface, and a tech bay for mounting multiple socket outlets (if required).

Warning

 Mounting the Uscan display on a mobile stand is configuring a medical system. Only use the

Signostics provided mobile stand accessory (P004013).

 The Uscan probe is connected to the Uscan display running Signostics software to configure a

medical system. The display has been certified by Signostics as part of a medical system to IEC 60601-1: 3rd edition.

 Do not connect the Uscan display to external computers or peripherals using the USB port unless the

system is outside the patient area. Failure to comply with these guidelines may result in electric shock.

 Only connect accessories or items that are specified as being compatible with Uscan. Contact

Signostics

customer support or your Signostics distributor for information on compatible accessories

and systems.

 When using the optional Signostics mobile stand, if a Multiple Socket Outlet is required only use an

outlet and power cable certified to IEC 60601-1, and fix to the stand using a bolt and tool.

To configure the system for mobile use, follow the instructions below (and see Fig 6.1):

1. Press and hold the Power button for 2 seconds to turn the Uscan Display on.

2. The Uscan application setup wizard will run. Setup the following:

2.1 Language.

2.2 Date and time.

2.3 Wi-Fi connectivity.

2.4 Registration information.

3. Insert the display into the mobile stand dock.

4. Insert the USB cable into the dock and probe.

5. If required mount a medical grade multiple socket outlet in the tech bay using a screw and bolt. Otherwise, use a medical grade extension cord (2-3m recommended). Plug the Signostics power supply in and push the cable up the pole.

6. Plug the Signostics power supply DC connector into the dock.

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P003948 Uscan User Manual Page | 39

7. Connect to an AC source and fully recharge the system.

Fig 6.1 Mobile stand setup

Cleaning

Signostics recommends the use of a soft cloth, lightly dampened with warm water or a mild soap solution for cleaning the mobile stand. Wipe surfaces with the moist cloth, and towel dry with a soft clean cloth.

Disinfection

Where bodily fluid or other contamination is expected, the mobile stand can be disinfected using the spray and wipe method with a variety of disinfection products. Follow the manufacturers recommended method. The following disinfecting means can be used with the Uscan mobile stand:

 T-Spray II by Pharmaceutical Innovations of New Jersey

 Sani-Cloth® Active by PDI of Flint, UK

 Tuffie 5 Wipes by VernaCare of Lancashire, UK

 Protex Disinfectant Wipes by Parker Laboratories of New Jersey

 Any Isopropyl alcohol impregnated wipes with <= 70% w/w alcohol

Refer to Signostics website for additional disinfection options.

First clean the mobile stand as above. Then wipe or spray the mobile stand with disinfectant, and leave for the disinfectant manufacturers recommended contact time. Remove any residue with a soft cloth moistened with water.

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7. SPECIFICATIONS

System dimensions

Table 7.1 Dimensions of probe

Component Height Width Depth Weight

Ultrasound probe

147mm

(5.7

8 inches)

62mm

(2.44 inches)

33mm

(1.3 inches)

~200g

(7.1 oz)

Table 7.2 Dimensions of cable

Component Length

Connecting cable, handheld display 900mm (35.43 inches)

Connecting cable, tablet display 1800mm (70.9 inches)

Table 7.3 Dimensions of displays

Component Height Width Depth Weight

Tab let

207mm

(8.15 inches)

137mm

(5.39 inches)

8mm

(0.31 inches)

350g

(12.3 oz)

Handheld

159.3mm

(6.27 inches)

77.8mm

(3.06 inches)

7.3mm

(0.29 inches)

179g

(6.3 oz)

Environmental Operating and Storage Conditions

The Uscan is intended to be used and stored in normal ambient conditions inside a medical facility.

Table 7.4 Operating, charging, transport and storage condition ranges for Uscan

Operating Transport and Storage

Temperature (°C)

5 (41°F) – 40°C (104°F)

40 °C (104°F)

5°C (41°F)

-20 (-4°F) – 50°C (122°F)

50 °C (122°F)

-20°C (-4°F)

Relative humidity (non-condensing) 15–90% 10–93%

Pressure 70–101.5 kPa (10.3-14.7 psi) 50–101.5 kPa (7.3-14.7 psi)

Table 7.5 Charging condition ranges for Uscan

Charging

Temperature (°C)

5 (41°F) – 40°C (104°F)

40 °C (104°F)

5°C (41°F)

Relative humidity (non-condensing) 20–80%

Pressure 70–101.5 kPa (10.3-14.7 psi)

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P003948 Uscan User Manual Page | 41

Mode of Operation

NON-CONTINUOUS - The Usc

an enforces non-continuous scanning to maintain safe user enclosure contact

temperatures. Non-continuous scanning is enforced as the enclosure temperature approaches 48°C.

Warning

 After storage

at extreme temperatures, check the transducer surface temperature before applying to a

patient. A cold or hot surface may burn a patient.

Caution

 Only operate, charge and store Uscan within the approved environmental parameters.

Power Supplies (Chargers)

For the Uscan probe, and tablet the power supply is Signostics Power Supply P003198

 Input: 100-240V AC supply 50-60Hz

 Output: 5.0V ±0.25V at 2.0A maximum current

The U

scan tablet display may also use the optional HP 18W AC power supply.

 Input: 100-240V AC supply 50-60Hz

 Output: 12.0V ±0.25V at 1.5A maximum current

For the optional U

scan mobile stand, the power supply is Signostics Power Supply P004016

 Input: 100-240V AC supply 50-60Hz

 Output: 12.0V ±0.25V at 1.5A maximum current

Internal battery

Ultrasound probe

Signostics Li-ion Polymer Cell

Description: Rechargeable lithium polymer battery

Rating: 3.7V 1350mAh

For the U

scan tablet display, the battery is a 21WHr Li-ion Polymer type.

Measurement accuracy

Measurements reflect a physical property such as area or volume for interpretation by a clinician. They do not account for variations in acoustic speed of the body, which can vary significantly.

Table 7.6 Accuracy of measurements

Measurement Units Range Accuracy Modes

Distance

Axial cm Full scale ±5% or ± 0.1cm B-mode

Lateral cm Full scale ±5% or ± 0.3cm B-mode

Vo lu me

ml 0-999ml ±10% or ± 10ml 3D

When used as per instructions scanning a bladder in a tissue equivalent phantom.

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P003948 Uscan User Manual Page | 42

Degree of Protection Against Ingress of Water

The ultrasound probe (P003992 or P003993) is IPX1 below the level of the USB connection.

The transducer lens can be submersed in liquid for testing purposes.

Fig 7.1 Water Protection

IPX1 below this line

Lens can be submersed for testing

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P003948 Uscan User Manual Page | 43

8. SAFETY

Ergonomics

Warning

 Avoid musculoskeletal strain with prolonged use of Uscan. Follow guidelines below.

The Uscan is intended for quick-look applications by qualified health professionals. It is not intended for continual use in radiology or other departments. If you need to use the device for a continual period, take the following precautions:

 Position yourself comfortably, either with a chair with appropriate lower back support or by sitting or

standing upright.

 Minimize twisting, relax your shoulders and support your arm with a cushion.

 Hold the probe lightly, keep your wrist straight and minimize the pressure applied to the patient.

 Take regular breaks.

External materials

The parts of the device that come into patient contact are biocompatible as assessed in ISO10993-1.

Disposal

Warning

 Do not incinerate or discard the device in general waste at end of life. The lithium battery is a potential

environmental and fire safety hazard.

Uscan contains lithium-polymer batteries and the system should be disposed of in an environmentally responsible manner in compliance with federal and local regulations. It is recommended the system is taken to a recycling center which specializes in the recycling and disposal of electronic equipment.

Where the device has been exposed to biologically hazardous material it is recommended the device be disposed of using biohazard containers and in compliance with federal and local regulations. It is recommended the system is taken to a waste center which specializes in the disposal of biohazard waste.

Electrical safety

Warning

 Uscan complies with the requirements of IEC 60601-1:3

Edition. To avoid the risk of injury or

electrical shock, comply with all safety instruction and warnings.

 The user must not touch the any device connectors while in physical contact with the patient.

 The Uscan probe is connected to an Android display running Signostics software to configure a

medical system. The Android display must be certified to the respective IEC standards and particular national deviations (IEC 60950 or IEC 60601-1:2nd and/or 3rd edition).

 Do not connect the Uscan display to external computers or peripherals using the USB port unless the

system is outside the patient area. Failure to comply with these guidelines may result in electric shock.

 Only connect accessories that are specified as being compatible with Uscan. Contact Signostics

customer support or your Signostics distributor for information on compatible accessories and systems.

 When using the optional Signostics mobile stand, if a Multiple Socket Outlet is required only use an

outlet and power cable certified to IEC 60601-1, and fix to the stand using a bolt and tool.

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P003948 Uscan User Manual Page | 44

Electromagnetic compatibility (EMC)

Caution

 Uscan contains sensitive components and circuits. Failure to observe proper static control procedures

may result in damage to the system. Any faults should be reported to Signostics

or your Uscan

distributor for repair.

Warning

 Uscan complies with the Electromagnetic Compatibility requirements of AS/NZ CISPR 11:2004 and

IEC 60601-1-2:2007. However, electronic and mobile communications equipment may transmit electromagnetic energy through air and there is no guarantee that interference will not occur in a particular installation or environment. Interference may result in artifacts, distortion, or degradation of the ultrasound image. If Uscan is found to cause or respond to interference, try re-orienting Uscan or the affected device, or increasing the separation distance between the devices. Contact Signostics customer support or your Signostics distributor for further information.

The Uscan is intended for use in the electromagnetic environment specified below. The user of the Uscan should assure that it is used in such an environment.

Table 8.1 Guidance and manufacturer's declaration: electromagnetic emissions

Emissions test Compliance Electromagnetic environment: guidance

RF emissions CISPR 11

Group 1 Uscan uses RF energy only for its internal function. Therefore, its RF emissions are very

low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A Uscan i

s suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Uscan has Class A compliance in meaning it is suitable for use in all establishments other than domestic and those directly connected to the

public low-voltage power supply network that supplies buildings used for domestic purposes. If Uscan is found to cause or respond to interference follow the guidelines in the warning section above

Table 8.2 Guidance and manufacturer's declaration: electromagnetic immunity

The user should assure the Uscan is used in the electromagnetic environment specified below.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment: guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8kV air

±6 kV contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors

are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast tra

nsient/burst

IEC 61000-4-4

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 1kV line(s) to line(s)

± 2kV line(s) to earth

± 1kV differential mode

± 2kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input li

nes

IEC 61000-4-11

<5% U

(>95% dip in

) for 0.5 cycle

40% U

(60% dip in

) for 5 cycles

70% UT (30% dip in UT for 25 cycles

<5% U

(>95% dip in

) for 5 sec

<5% U

(>95% dip in

) for 0.5 cycle

40% U

(60% dip in

) for 5 cycles

70% UT (30% dip in UT for 25 cycles

<5% U

(>95% dip in

) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment.

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P003948 Uscan User Manual Page | 45

Notes for Table 8.2

UT is the AC mains voltage prior to application of the test level

At 80MHz and 800 MHz, the higher frequency range applies

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Uscan is used exceeds the applicable RF compliance level above, Uscan should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating Uscan.

Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m

Warning

 When using the optional mobile stand, the Uscan system can be susceptible to ESD and may require

manual intervention. If ESD results in a Uscan error, unplug the probe and plug back in to restore operation.

Power frequency  (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels

characteristic of a typical location in a typical commercial or hospital environment.

2,3

Conducted RF

IEC 61000-4-6

3 Vrms

150kHZ 80MHz

3 Vrms Portable and mobile RF communications equipment

should be used no closer to any part of Uscan, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter

Recommended separatio

n distance

d = 1.2

Radiated RF

IEC 61000-4-3

3 V/m

80MHz 2.5 GHz

3 V/m

d=1.2P 80MHz to 800MHz

d=2.3P 800MHz to 2.5GHz

Where P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separations distance in meters (m).

Field strengths from fixed RF tra

nsmitters, as determined by an electromagnetic site survey4, should be less than the compliance level in each frequency range5.

Interference may occur in the vicinity of equipment marked with the following symbol.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment: guidance

Page 48

P003948 Uscan User Manual Page | 46

Table 8.3 Separation Distances

Recommended separation distances between portable and mobile RF communications equipment and the Uscan

The Uscan is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Uscan can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Uscan as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

powe

r of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

d=1.2

80 MHz to 800 MHz

d=1.2

800 MHz to 2,5 GHz

d=12.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended sepa

ration distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance fo

r the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Power Supplies (Chargers)

The external Signostics power supplies (chargers) comply with the requirements of IEC 60601-1. The display power supply (charger) complies with IEC 60950-1.

Warning

 Do

not open or modify the Signostics Power Supply P003198 or any other supplied power supplies -

Risk of electric shock

Biological safety

The device can be disinfected for re-use on immunocompromised and non-immunocompromised patients after:

 Frequent contact with healthy skin (frequent low risk).

 Occasional contact with mucous membra

nes or contamination with particularly virulent or readily

transmissible organisms (occasional intermediate risk).

Warning

 Neurologic

al use on patients with Creutzfeld-Jacob disease must not be performed. The device is

unable to be disinfected after such use.

Acoustic Output

Warning

 The ALARA principle (As Low As Reasonably Achievable) should be employed for all medical

ultrasound exposure

Ultrasound imaging has been in regular use for over 20 years and ha

s an excellent safety record. Even though there are no known risks of ultrasound imaging, it heats the tissues slightly and may produce small pockets of gas in body fluids or tissues (cavitation). The long-term effects of tissue heating and cavitation are not known.

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P003948 Uscan User Manual Page | 47

Given potential does exist for bio-effects with ultrasound exposure, any exposure should be kept As Low As Reasonably Achievable. Scans should only be performed when there is a medical benefit and in the shortest

time commensurate with obtaining an adequate study. As the acoustic output of the device does not exceed an MI or TI of 1.0, visual display of MI and TI values is not required. A generic ALARA education program is supplied with your Uscan (see enclosed ISBN 1-93004 7-71-1, Medical Ultrasound Safety).

Table 8.4 Acoustic output and uncertainties for Uscan

SPTA.3

[mw/cm

]

TI type TI Value MI

PA. 3

@MI

max

[W/cm

]

P004200 Output 5.69 TIS 0.09 0.823 143

P004200

Uncertainties ±9.2% ±9.2% ±4.6% ±9.2%

SPTA.3

Derated spatial peak, temporal average intensity (milliwatts/cm2) TI Thermal index MI Mechanical index I

PA. 3

@MI

max

Derated spatial-peak pulse-average intensity (watts/cm2) Uncertainties are the cumulative e

ffect of measurement uncertainties.

Page 50

P003948 Uscan User Manual Page | 48

9. ADVANCED DEVICE AND IT SETUP

The system provides a number of advanced configuration options to enable an institution to setup and manage the devices in their facility.

 Administrators can lock preferences with a password.

 Administrators can implement user management.

 Multiple devices can be setup with common preferences.

 Restrict ultrasound scanning and rest

rict viewing images during bladder scanning.

 Restrict recording of ultrasound data and bladder data.

 Restrict access to USB storage.

 Devices can be linked to a Google acc

ount to enable device tracking, remote alarms, and other

functions to reduce the likelihood of devices being lost.

Administrator Setup

 From the Home screen, tap and select Settings.

 Select Administration.

 Under Secu

rity, tap on Enable Administrator Password.

 Enter an administrator password. Ensure you rec

ord the password in a secure location and do not

forget or lose it.

As soon as an administrator password is se

tup, preferences and settings can only be changed by the

administrator.

Software Updates Restrictions

 From the Home screen, tap and select Settings

 Select Administration.

 Automatic Updates Check –

check to automatically check for software updates (updates are not

available in Japan).

 Allow USB Software Updates – check to allow installa

tion of software updates via USB.

Page 51

Fig 9.1 Add User

Fig 9.2 User Login

Fig 9.3 Export Settings

P003948 Uscan User Manual Page | 49

User Management

 From the Home screen, tap and select Settings.

 Select Administration the

n select Manage Users.

 Tap th e

icon in the top right of the screen.

 Enter a Username, Family name,

Given name, and if

required set the password (see Fig

9.1).

 Tap Sa

ve to finish.

The user will need to enter a user name and password to save pati

ent data (see Fig

9.2).

Multiple Device Setup

To setup multiple devices with identical preferences and users, first configure one device with the required settings (see

Preference SetupSettings).

Export the settings to a file:

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Settings

Management.

 Select Export

Uscan Settings.

 Tap

to write the settings to an xml file.

 Copy the xml file from the tablet or handheld display

to a host comput

er (for example by connecting the tablet to a computer by a USB cable and copying the file from the tablet to the computer).

On each of the other syst

ems to be setup, import the settings:

 Turn the tablet or handheld disp

lay on and follow the

initial setup instructions (see

Setting up the System).

 Copy the xml file from the host computer to the

display local st

orage.

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Settings

Management.

 Select Import Scan

Settings.

 Select the xml file to import.

Ultrasound Scanning Restrictions

To setup a password for accessing ultrasound scanning functionality:

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Restrict Ultrasound Scanning.

 Enter a password for accessing ultrasound functionality

. Ensure you record the password in a secure

location and do not forget or lose it.

To require ultrasound scanning passw

ord for viewing images during bladder scanning:

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P003948 Uscan User Manual Page | 50

 From the Home screen, tap and select Settings.

 Select Administration the

n select Restrict Viewing Images during Bladder Scanning.

 The ultrasound scanning password w

ill be required to view images during bladder scanning.

Data Recording Restrictions

The Uscan enables institutions to restrict saving, printing, and exporting ultrasound and/or bladder data.

To restrict Ultrasound Data Recording:

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Ultrasound Data under Recording.

 Select Do not allow recording to rest

rict recording ultrasound data.

To restrict Bladder Data Recording:

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Bladder Data under Recording.

 Select Allow rec

ording volume only to restrict recording bladder images but allow recording volumes.

 Select Do not allow recording to rest

rict recording all bladder data.

Storage Access Restrictions

To restrict access to exported images via USB:

 From the Home

screen, tap and select Settings.

 Select Administration the

n select Restrict access to exported images via USB under Storage Access.

Device Tracking

To track a device it needs to be connected to Wi-Fi and linked to a Google account.

Go to

https://accounts.google.com/signup on a computer to create a Google account.

To setup tracking perform the following on the Usc

an display:

 From the Home

screen, tap and select Settings then select System Settings.

 Select Accounts

 Tap Add Account

 Select Google

 Enter your Google email and tap Next.

 Enter your password and tap Next.

 Optional – uncheck Google Se

rvices. Tap Next.

 Select “No Thanks” for Payment Info.

Tap Next.

 Tap Home

to return to the Uscan Home screen.

 From the Home

screen, tap and select Settings then select System Settings.

 Select Location

 Slide the on-screen button to the right

to turn Location Services on.

 Tap Go

ogle Location History

 Slide the on-screen button to the right

to turn on Google Location History.

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 Tap Home to return to Uscan Home screen.

Use any Android device or computer to login to the Google Accoun

t and select “Find your phone”.

All devices linked to the Google Account are tracked and can be made to ring at full volume using a web browser.

Fig 9.2 Device Tracking

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REFERENCES

IEC 60601-1:2005 (3rd edition), Medical Electrical Equipment-Part 1. General Requirements for Basic Safety

and Essential Performance.

IEC 60601-1-2:2007 (3rd edition), Medical Electrical Equipment. General Requirements for Basic Safety and

Essential Performance. Collateral Standard. Electromagnetic compatibility requirements and tests.

IEC 60601-2-37:2007 (2nd edition), Particular requirements for the basic safety and essential performance of

ultrasonic medical diagnostic and monitoring equipment.

IEC 60950-1:2005, Information Technology Equipment. Safety-Part 1: General Requirements.

ISO 10993-1: 2003, Biological Evaluation of medical devices

ISBN 1-93004 7-71-1, Medical Ultrasound Safety.

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Glossary

Bladder volume Volume of urine in the bladder

Exam A unique interaction between a clinician and patient. Up to 50 images may be saved to

each exam. Exams are identified by patient name and/or by date and time of scan.

Patient A single person, with unique details such as name, gender, date of birth and EMR

(electronic medical record).

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Index

INDEX

about

Uscan

......................................................................2

User Manual ................................... See User Manual

accessories

................................................................. 37

acoustic output

...........................................................47

ALARA principle

...................................................... 47

alcohol

.................................................................10, 35

applications ........................................See indended uses

audio feedback

...........................................................27

battery

........................................................................41

disposal

............................................................10, 43

recharge

........................................... 8, 9, 14, 37, 38

replacement

...........................................................34

biological safety..............................................See safety

calipers...................................... See also Measurement

cautions

......................................................................10

cavitation

...................................................................46

charger ...............................................See mains charger

classifications

..............................................................7

clinical troubleshooting

.............................................36

connecting cable

........................................................ 40

contact information

..............................................12, 36

contraindications.............................................See safety

Customer Support

......................................................36

dimensions

................................................................. 40

Display specifications

..................................................2

disposal

......................................................................43

distance ............................................. see Measurement

electrical safety ...............................................See safety

electromagnetic compatibility

................................... 44

exams

.........................................................................53

external materials

.......................................................43

Image Annotations

voice

......................................................................29

Intended uses

............................................................... 3

IPX Rating

.................................................................42

labeling

...................................................................... 11

latex

.......................................................................9, 23

mains charger

.............................................................46

input

.......................................................................41

maintenance

...........................................................9, 34

Measurement

accuracy

................................................................41

B-mode

.................................................................. 25

microphone

................................................................29

musculoskeletal strain

...........................................9, 43

navigate................................................ See touch screen

package contents

.......................................................... 6

patient environment

.....................................................8

patients

.......................................................................53

Power

button

....................................................... 15, 28, 38

sources

.............................................................37, 38

recommended gel

...................................................... 23

recording

.................................................................... 29

references

...................................................................52

safety

......................................................................... 43

biological

............................................................... 46

contraindications

...............................................3, 10

electrical

..........................................................10, 43

service..................................................See maintenance

setup

........................................................................... 15

shutdown

................................................................... 28

solvents

................................................................10, 35

sterile sheaths

............................................................ 23

support

....................................................................... 36

system features

............................................................ 7

touch screen

navigating

..............................................................16

trademarks

................................................................. 12

training

.........................................................................5

turn off

....................................................................... 28

turn on

..................................................................15, 38

ultrasound

gel

.......................................................................... 23

probe

......................................................................40

risks

....................................................................... 46

User Manual

................................................................1

conventions

............................................................. 1

version

..................................................................... 1

version

User Manual ....................................See User Manual

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Index

warnings

......................................................................8

Zooming

....................................................................25