User's Manual
Table Of Contents
- 1 Read This First
- 2 Safety Information
- 3 Overview
- 4 Preparing the System
- Inserting a microSD Card
- Using the Stand
- Charging the System
- Connecting the Transducer
- Removing the Transducer
- Using the System On The Go
- Using the Wheel Brakes
- Placing the Transducer Holder
- Mounting the System to the System Cart
- Adjusting the System Cart Height
- Connecting an External Printer
- Tilting the System
- Unmounting the System From the System Cart
- Moving the System
- Outputting the System Display to an HDMI-Enabled TV or Monitor
- Supported External Printers
- 5 Using the System
- Turning On/Off the System
- Logging Into the System
- Launching the Main Screen
- Setting the System Time and Date
- Controlling the System
- Setting the System Language
- Identifying the Main Screen Layout
- Switching the Control Panel Pages
- Managing the System Power
- Managing Disk Space
- Network Configuration
- DICOM Configuration
- 6 Performing an Exam
- Starting a New Exam
- Adding a New Patient
- Loading a Worklist
- Selecting a Preset
- Setting the Transducer Orientation
- Selecting/Switching a Scan Mode
- Adjusting the Displayed Image
- Freezing an Image
- Adding Annotations
- Adding Measurements
- Saving and Printing the Image
- Reviewing the Image
- Exporting the Exam
- Managing the Exam List
- Ending the Exam
- 7 Using Image Controls
- 2D Mode Image Controls
- Overview
- Adjusting Gain
- Adjusting Frequency
- Adjusting Time Gain Compensation (TGC)
- Adjusting the Scan Depth
- Adjusting the Focus Depth, Focal Zone and Focal span
- Adjusting Dynamic Range
- Using Tissue Harmonic Imaging (THI)
- Adjusting Persistence
- Adjusting Sharpness and Smoothing
- Adjusting Gray Map
- Adjusting Chroma Map
- Adjusting Steer Angle
- Adjusting the Sector Width and Position
- Adjusting Power
- Using Trapezoidal Imaging
- Adjusting Density
- Using Compound Imaging
- Using ENV (Enhanced Needle Visualization)
- Color/CPA Mode Image Controls
- M-Mode Image Controls
- Spectral Doppler Mode Image Controls
- 2D Mode Image Controls
- 8 System Customization and Service
- Customizing Your System
- Configuring Security Policies
- Servicing your system
- Reinstalling Software
- Checking the Software Version
- Checking the System’s Serial Number
- Checking the Tablet’s Serial Number
- Checking the License Status
- Resetting User Settings
- Backing Up System Settings and Patient Data
- Restoring System Settings and Patient Data
- Resetting Your System
- Testing the System
- Exporting System Logs
- Reading the User Manual
- 9 Transducers
- 10 Transducer Care
- 11 System Maintenance
- 12 Appendix
InnoSight Ultrasound System
Indications for Use and Supporting Transducers
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36
P6992-4, EN, 16/12/6
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: InnoSight Diagnostic Ultrasound System
Transducer: L12-4 (Linear Array 4-12 MHz)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical application Mode of operation
General
(Track 1 only)
Specific
(Track 1 and 3)
2D M-Mode
PW
Doppler
CW
Doppler
Color CPA
Other
Combined
Tissue
Harmonic
Imaging
Ophthalmic Ophthalmic
Fetal imaging
and others
Fetal
Abdominal N N N N N Note 1 N
Intra-operative
Specify
Intra-operative
Neuro
Laparoscopic
Pediatric
Small Organ
(breast, thyroid,
testes)
N N N N N Note 1 N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-
Card)
Musculoskeletal
(Conventional)
N N N N N Note 1 N
Musculoskeletal
(Superficial)
Intravascular
Other (OB/GYN)
Cardiac
Cardiac Adult
Cardiac Pediatric
Intravascular
(Cardiac)
Trans-esoph
(Cardiac)
Intra-cardiac
Other (specify)
Peripheral
vessel
Peripheral Vessel N N N N N Note 1 N
Other (specify)
N new indication P previously cleared by FDA E added under this appendix
Note 1: Combined modes include: 2DM-Mode 2DPW Doppler 2DColor 2DCPA 2DColorPW
Doppler and 2DCPAPW Doppler