Table of Contents
Advertisement
Advertisement
Table of Contents
Troubleshooting
Summary of Contents for Signostics uscan
-
Page 1: User Manual
User Manual P003948 November 2017 www.signosticsmedical.com... -
Page 2: Table Of Contents
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 .................... -
Page 3: About The User Manual
Transducer cleaning and disinfection............35 Cleaning ....................35 Disinfection ....................35 Troubleshooting ................... 36 Clinical Troubleshooting ................36 Signostics Customer Support ..............36 Connectivity And Accessories..............37 Accessories ....................37 Power sources ..................... 37 Internal battery ..................... 37 Power Supplies (Charger) ................37 Mobile Stand Setup .................. -
Page 4: Important Information
NFORMATION 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. - Page 5 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.
-
Page 6: Intended Uses Of Uscan
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. - Page 7 System and Transducer applications Table 1.1 Uscan applications Clinical Application Mode of Operation B-mode/ B-mode/ General Specific B-mode M-mode PW Doppler Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (specify) Intra-operative (neuro) Laparoscopic Pediatric Small organ (specify)* Neonatal cephalic Fetal imaging &...
-
Page 8: Training
* 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... -
Page 9: Contents Of The Uscan Packages
Contents of the Uscan packages Your 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: ... -
Page 10: System Features
System Features The front of the Uscan tablet display and probe are shown in 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... -
Page 11: Patient Environment
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. - Page 12 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.
-
Page 13: Cautions
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. -
Page 14: Labeling
Part Number Serial number Date of manufacture max °C Temperature limitation min °C Humidity limitation Atmospheric pressure limitation Stack box this way up Direct Current (DC) Alternating Current (AC) Dangerous voltage P003948 Uscan User Manual Page | 11... -
Page 15: Contact Information
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. ® ® ®... -
Page 16: Getting Started
TARTED Unpacking the Boxes Your 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 (with pre-installed Signostics software), associated power supply, probe connection cable, protective cover, and setup guide. -
Page 17: Setting Up The System
Setup. To configure the system for mobile use, follow the instructions below (and see 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: Language. -
Page 18: Basic Device Control
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. -
Page 19: Settings
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. - Page 20 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. P003948 Uscan User Manual Page | 18...
-
Page 21: Network Printer Setup (Optional)
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. P003948 Uscan User Manual... -
Page 22: Imaging Screens
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 screen to start an ultrasound exam. See Fig 2.6... - Page 23 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. P003948 Uscan User Manual Page | 21...
- Page 24 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. P003948 Uscan User Manual Page | 22...
-
Page 25: Recommended Ultrasound Transmission Gel
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. -
Page 26: Scanning
The system is powered on and has battery charge available to scan (the probes LED is flashing green and the display battery icons shows charge). The Uscan transducer has been cleaned or disinfected as appropriate (See Transducer cleaning and disinfection). -
Page 27: Ultrasound Scanning
Tap a shape to re- select it for editing. The units of measurement are cm for distance and cc for volume. Fig 3.6 Volume Measurement P003948 Uscan User Manual Page | 25... -
Page 28: Ultrasound Movies
When fanning consider the following: Do not allow the transducer to slip across the Fig 3.10 Transducer Positioning patient's skin. P003948 Uscan User Manual Page | 26... -
Page 29: Audio Feedback
Tap End Editing to finish. Fig 3.13 Adjusting outline Audio Feedback The Uscan provides audio feedback during bladder measurement as follows: A short double beep sounds when the system has detected a bladder and the user can start the fan of the probe ... -
Page 30: 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. P003948 Uscan User Manual Page | 28... -
Page 31: Other Functions
Fig 4.2 Annotation list Press the Microphone icon to record. Speak clearly into the Uscan 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. -
Page 32: Entering Patient Details
Bluetooth Printer Setup (Optional)). Network printing uses a Mopria service (see www.mopria.org) enabling printing to thousands of network printer types. The Uscan needs to be connected via WiFi to the same network as the printer. To print: Tap the icon. -
Page 33: Export
Tap EXPORT ALL to export all 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). -
Page 34: Deleting Exams And Patients
No internet ports are open. In the event 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. P003948 Uscan User Manual Page | 32... -
Page 35: Setting A Device Password
Setting a Device Password To set a device pin or password 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. -
Page 36: Maintenance And Troubleshooting
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. -
Page 37: Transducer Cleaning And Disinfection
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. -
Page 38: Troubleshooting
If probe is still not recognized, unplug the probe and connect directly to the Signostics power supply (P003198) and leave for 2 hours to charge. The Uscan battery fails to recharge after a period of heavy use. -
Page 39: Connectivity And Accessories
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. -
Page 40: Mobile Stand Setup
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. -
Page 41: Cleaning
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. -
Page 42: Specifications
(0.29 inches) (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 5 (41°F) –... -
Page 43: Power Supplies (Chargers)
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 Uscan tablet display may also use the optional HP 18W AC power supply. -
Page 44: 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. IPX1 below this line Lens can be submersed for testing Fig 7.1 Water Protection P003948 Uscan User Manual Page | 42... -
Page 45: Safety
(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. -
Page 46: Electromagnetic Compatibility (Emc)
IEC 61000-3-3 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... - Page 47 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.
-
Page 48: Power Supplies (Chargers)
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. - Page 49 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...
-
Page 50: Advanced Device And It Setup
Automatic Updates Check – check to automatically check for software updates (updates are not available in Japan). Allow USB Software Updates – check to allow installation of software updates via USB. P003948 Uscan User Manual Page | 48... -
Page 51: User Management
From the Home screen, tap and select Settings. Select Administration then select Settings Management. Select Export Uscan Settings. Fig 9.2 User Login Tap to write the settings to an xml file. Copy the xml file from the tablet or handheld display... -
Page 52: Data Recording Restrictions
The ultrasound scanning password will 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. - Page 53 Tap Home to return to Uscan Home screen. Use any Android device or computer to login to the Google Account 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.
-
Page 54: References
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. P003948 Uscan User Manual Page | 52... -
Page 55: Glossary
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). P003948 Uscan User Manual Page | 53... -
Page 56: Index
NDEX Measurement accuracy ..............41 about B-mode ..............25 Uscan ..............2 microphone ..............29 User Manual ........See User Manual musculoskeletal strain ...........9 accessories ..............37 acoustic output ............47 ALARA principle ............47 navigate..........See touch screen alcohol ..............10 applications ........See indended uses... - Page 57 ..............8 Zooming ..............25 P003948 Uscan User Manual Page | 55...
Need help?
Do you have a question about the uscan and is the answer not in the manual?
Questions and answers