Table of Contents
Advertisement
Equipment Manufacturer
Interson Corporation
7150 Koll Center Parkway
Pleasanton, CA 94566 USA
Phone: 925.462.4948
Fax: 925.462.4833
Email: support@interson.com
Website: www.interson.com
2797
Information in this document is subject to change without notice.
These Instructions For Use are applicable to the following Simpli
GP-C01
SP-L01
© Copyright Interson Corporation. All rights reserved. No part of this manual or software may be
reproduced in any form or by any means, electronic or mechanical, including but not limited to
photocopying, recording, or by any information storage and retrieval systems, without the express
written consent of Interson Corporation.
Windows is a trademark of Microsoft Corporation
Interson, SimpliVue and Simpli Series are trademarks of Interson Corporation
Simpli Series
Ultrasound Imaging System
M
Instructions For Use
EC Representative
MedNet GmbH
Borkstraße 10
48163 Münster
Germany
Phone: +49 251 32266-61
Fax: +49 251 32266-22
TM
Series probes:
P
Advertisement
Table of Contents
Related Manuals for INTERSON Simpli Series
Summary of Contents for INTERSON Simpli Series
- Page 1 GP-C01 SP-L01 © Copyright Interson Corporation. All rights reserved. No part of this manual or software may be reproduced in any form or by any means, electronic or mechanical, including but not limited to photocopying, recording, or by any information storage and retrieval systems, without the express written consent of Interson Corporation.
-
Page 2: Table Of Contents
Prepare to call customer service:......................13 Taking the probe to a service partner:....................13 Probe Preparation ........................... 13 General Use ............................. 13 Invasive or Surgical Use .......................... 13 Installing Sheaths ..........................13 Getting Started ............................15 Simpli Series System Instructions for Use 01-5034-00 R1... - Page 3 Configuring Cine Duration........................24 Configuring Cine Compression Setting ....................24 Review ................................. 25 Reviewing Images ........................... 25 Reviewing Cines ............................25 Generating Reports ..........................25 Deleting Images, Cines, and Reports ...................... 26 Simpli Series System Instructions for Use 01-5034-00 R1...
- Page 4 Adjusting Image Controls to Minimize the Indices ................. 38 ALARA Resources ............................ 38 Appendix G – Interson Ultrasound Probes – Indications for Use ............... 39 Appendix H – EMC Information ........................41 Appendix I – Maximum Probe Temperature ....................43 Appendix J –...
-
Page 5: Overview
Congratulations on your purchase of the Interson Simpli Series Ultrasound Probe System. Please review this user manual before you begin imaging. Contact Interson or your sales representative if you have any question. Note: The sale of this item is subjected to regulation by the U.S. Food and Drug Administration (FDA) and state and local regulatory agencies. - Page 6 The use of AC adapters which have not been tested for electrical safety could potentially cause harm to the system, the probe, the operator and/or the patient. Interson recommends that you use only the AC adaptor supplied by the manufacturer of your computer or tablet. Such adaptors should display certification of electrical safety testing.
-
Page 7: Symbology
Symbology The following symbols may be used on Interson labeling: Symbol for “Serial Number” Symbol for “Part Number”... -
Page 8: Ultrasound Probes
A Color Flow Mapping (CFM) mode provides a qualitative indication of fluid flow and direction. The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 1024 sequential images). Management of patient history is possible by image-storage function. -
Page 9: Electromagnetic Compatibility (Emc)
Portable and mobile RF communications equipment may affect the normal function of the Interson USB Ultrasound Probes. CAUTION Do not use cables or accessories other than those provided with the Interson USB Ultrasound Probe, as this may result in increased electromagnetic emissions or decrease immunity to such emissions. Care and Handling of Probes Although Interson probes are very durable, reasonable care must be taken to avoid damaging them. -
Page 10: Cleaning And Disinfection
FDA 510(k) Cidex® Liquid Gluteraldehyde K924434 Cidex Plus® Liquid Gluteraldehyde K923744 Sporicidin® Liquid Phenol K904581 Revital- Ox Hydrogen Liquid K080420 Resert® HLD Peroxide 1. Wear protective gloves when performing the disinfecting procedure. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 11: Training
Disinfect probes using only liquid solutions. Using autoclave, gas (EtO), heat or radiation to sterilize or other non-Interson-approved methods will permanently damage the probe and void the warranty. 1. Examine the probe for damage such as cracks, splitting, sharp edges or projections. If damage is evident, abandon disinfection, discontinue use of the probe, and contact a customer service representative. -
Page 12: Transportation
• When returning for repair, return probe in original package. If the original package is not available, contact Interson for the best packaging method prior to sending a probe in for evaluation and possible repair. Disposal 1. -
Page 13: Customer Service
Customer Service If you are not able to find the solution by using this manual, contact Interson customer service or local Interson distributor. Prepare to call customer service: To receive the fastest possible resolution of a problem, have the following information available when calling (925) 462-4948 or emailing support@interson.com:... - Page 14 5. Check for and eliminate bubbles between the face of the transducer and the sheath. If any bubbles are present between the face of the transducer and the sheath, the ultrasound image may be affected. 6. Inspect the sheath to ensure there are no holes or tears. Simpli Series System Instructions for Use 01-5034-00 R1...
-
Page 15: Getting Started
Getting Started Minimum System Requirements Interson cannot guarantee that SimpliVue will work on your device without issue, but your device must meet or exceed the following specifications: • Operating System: Windows 7 & 10 • Processor: 2.5 GHz • Memory: 4 GB •... -
Page 16: Imaging Display
Navigation menu (new exam, enter patient information, review exam, settings, help) Image area Image information Probe selection System controls area Depth selection Frequency selection Imaging controls area (CFM, save image, save cine, measurement & annotation) Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 17: Using Simplivue
Touch the field you want to edit and use the keyboard to replace, insert, or delete text. Touch Save. 3. To close the Patient Information window, touch the X at the top right corner of the open window. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 18: Optimizing The Image
To save changes to image control adjustments, touch Save. Enter a new name in the Save dialogue box if you wish to create a new preset. k. To reset any image control adjustments to the last saved settings, touch Reset. Simpli Series System Instructions for Use 01-5034-00 R1... - Page 19 2. To increase or decrease the image depth, adjust the Depth selection slider. 3. To increase or decrease the probe operating frequency, touch a frequency you want from the frequency selection. Simpli Series System Instructions for Use 01-5034-00 R1...
-
Page 20: Imaging Modes
If no patient profile has been selected, the acquired cine is saved in the _Stat Images folder by default. Imaging Tools Touch Additional Tools to display a pop-up menu of annotation, pointer, measurement, calculation tools on the screen. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 21: Annotation
4. To remove the last measurement, touch Undo 5. To remove all measurements, touch Clear All Performing Area and Circumference Measurements 1. There are three shape tools available to measure area and circumference: Circle Freehand , and 5-points Simpli Series System Instructions for Use 01-5034-00 R1... - Page 22 2. Touch the image area to place the three calipers. The angular measurement result is displayed next to the second caliper. 3. Touch Angle to stop angular measurements. 4. To remove the last measurement, touch Undo Simpli Series System Instructions for Use 01-5034-00 R1...
-
Page 23: Statement Of Accuracy
The experience and diligence of the operator in achieving a quality image are major factors in the accuracy of distance measurements. The operator must ensure that measurements are made only on suitable images to achieve accurate measurements. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 24: General Settings
Configuring Cine Compression Setting Expand the Compression drop-down list. For more compression (reduce the cine file size), select a higher compression ratio. For less compression (increase the cine file size), select a lower compression ratio. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 25: Review
Refer to Editing Patient Information and Acquiring Images. 2. Touch Save to Report 3. Touch Print . An html report is saved in the patient exam folder and automatically opened in a web browser for review. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 26: Deleting Images, Cines, And Reports
All images, cines, and reports are accessible by navigating to the patient exam folder in Files Explorer. These files could be sent as an attachment in an e-mail through the e-mail application of your choice. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 27: Remote Viewing With Vsee
2. On the left-hand navigation menu, click Settings. 3. With Settings displayed, click Video. 4. Click the drop-down list and select Ultrasound Stream. Your device is now configured to share live imaging on VSee Messenger. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 28: Add Contacts In Vsee Messenger
Click the video icon at the upper- right corner of the chat window. Once both users connect to the call, the video call will initiate with the device running SimpliVue sharing the ultrasound image with the remote user. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 29: Appendix A - Simplivue Software Installation
8. Launch the SimpliVue software using the desktop shortcut. 9. The SimpliVue software will now launch and you are ready to begin imaging. *The name of the installation file may differ depending on the version of the SimpliVue software. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 30: Appendix B - Interson Probe System Specifications
Appendix B – Interson Probe System Specifications Imaging Mode B Scan • Functions Standard USB port (2.0) connectivity • Multiple freeze methods: button on probe, keyboard, or button on screen • Auto image save on Freeze • Image Resolution 0.1 to 2.0 mm resolution* •... -
Page 31: Appendix C - Computer System Specifications
Interson Corporation – SimpliVue WARNING Do not use cables or accessories other than those provided with the Interson USB ultrasound probe, as this may result in increased electromagnetic emissions or decrease immunity to such emissions. The use of a “Non-Medical” grade AC Adapter could potentially cause harm to the system, the probe, the operator and/or the patient. -
Page 32: Appendix D - Interson Probes And Their Applications
This device is a hand-held, curved linear array solid-state sector probe intended for transcutaneous use with the Interson USB Ultrasound Probe System. The nominal operating frequency is 5.0 MHz with upper and lower range ends of 7.5 MHz and 3.5 MHz respectively. The operating modes are B and combined B + color Doppler modes. -
Page 33: Appendix E - Summary Of The Acoustic Quantities
Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51.2 aa) and 51.2 dd). Intended use does not include cephalic so TIC is not computed. Simpli Series System Instructions for Use 01-5034-00 R1... - Page 34 Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51.2 aa) and 51.2 dd). Intended use does not include cephalic so TIC is not computed. Simpli Series System Instructions for Use 01-5034-00 R1...
- Page 35 Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51.2 aa) and 51.2 dd). Intended use does not include cephalic so TIC is not computed. Simpli Series System Instructions for Use 01-5034-00 R1...
- Page 36 Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51.2 aa) and 51.2 dd). Intended use does not include cephalic so TIC is not computed. Simpli Series System Instructions for Use 01-5034-00 R1...
-
Page 37: Appendix F - Achieving Alara
Scanning time should be kept to a minimum. However, do not shorten the session so much that a follow-up exam is necessary as this would only increase the overall exposure for the patient. Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 38: Display Of Indices
Medical Ultrasound Safety, Third Edition, AIUM 2014 American Institute of Ultrasound in Medicine Bioeffects Consensus Report Vol. 27, Issue 4, April 2008 AIUM Consensus Report on Potential Bioeffects and Safety of Diagnostic Ultrasound." January 1993 Simpli Series System Instructions for Use 01-5034-00 R1... -
Page 39: Appendix G - Interson Ultrasound Probes - Indications For Use
Appendix G – Interson Ultrasound Probes – Indications for Use The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: •... - Page 40 Intravascular Other (Urology) Other (Gynecology) Other (Pelvic Floor) Other (Neuromuscular) Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Peripheral vessel Other (Specify) Simpli Series System Instructions for Use 01-5034-00 R1...
-
Page 41: Appendix H - Emc Information
Guidance and manufacturer’s declaration – electromagnetic emissions Interson’s USB Ultrasound Probes are intended for use in the electromagnetic environment specified below. The customer or the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment. Emissions test... - Page 42 Guidance and manufacturer’s declaration – electromagnetic immunity Interson’s USB Ultrasound Probes are intended for use in the electromagnetic environment specified below. The customer or the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment. Electromagnetic environment – guidance...
-
Page 43: Appendix I - Maximum Probe Temperature
Appendix I – Maximum Probe Temperature Interson probes will not exhibit excessive surface temperatures under normal use. Disconnect the equipment if unsafe temperatures are observed. Interson probes have been tested to conform with IEC 60601-2-37. Max. Temp. Max. Temp. Probe... -
Page 44: Appendix J - Patient Privacy And Confidentiality
5. Regularly back up your data and store in a safe place. Note: Interson software does not include electronic signature control and is not meant to substitute for an electronic medical record. Simpli Series System Instructions for Use... -
Page 45: Appendix K - Calculations
Industry standard calculations* are available from the Measure Tab. Specific calculations may or may not be available depending on the version and date of your SimpliVue software. Contact Interson about enabling specific calculations that are not available in your version of SimpliVue software. -
Page 46: Appendix L - Interson Customer Warranty
The Company agrees to replace or correct any defects or errors in the Product for a period of two years from the date of purchase from an authorized Interson dealer. The Company's sole liability and the exclusive remedy shall be, at the Company's option, the repair or replacement of the Product. The Company makes no additional representations or warranties, express or implied, regarding the Product and/or its use. -
Page 47: Appendix L - Warranty And Extended Warranty Registration
Appendix L – Warranty and Extended Warranty Registration Interson probes come with a standard two-year return-to-factory warranty. You can register your probe(s) online at http://www.interson.com/registration or make a copy of this form, fill out your information, and mail to Interson.
Need help?
Do you have a question about the Simpli Series and is the answer not in the manual?
Questions and answers