A Nemaris
Company
User
Guide
DATE: 11-11-2011
REVISION 1.9
Important Notice
Copyright and Trademark Notice
The trademarks, logs, and service marks displayed throughout this document are property of Nemaris Inc. Use thereof is only permitted with written consent from Nemaris Inc.
Limitations of Liability
Information on this document is provided “AS IS” and without warranty of any kind, either expressed or implied, including, without limitation, warranties of any kind. Nemaris Inc. uses reasonable efforts to include accurate information and makes periodic updates available online without notice. Nemaris Inc. makes no warranties or representations as to the accuracy or completeness of such information, and assumes no liability or responsibility for errors or omissions in the content of this document. Your use of this document is AT YOUR OWN RISK. Under no circumstance and under no legal theory or provision shall Nemaris, Inc. be liable to you or any other person for any direct, indirect, incidental, exemplary, or consequential damages arising from your access to, or use of this document. Product information is subject to change without notice. Changes, if any, will be incorporated in new editions of publications. Nemaris Inc. retains the right to make improvements and/or changes in the products and/or the programs described in the publications and information provided at any time and without prior notice.
Disclaimer
Surgimap Spine is intended as a decision support system for persons who have received appropriate medical training, and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or management. All information derived from the software must be clinically reviewed regarding its plausibility before use in treating patients. Any derivation of the application of medical information from the program, other than the original design or intended use thereof, is not advised and considered a misuse of the software product.
Caution
Federal Law restricts this device to sale by or on the order of a physician
Limit of Accuracy for Surgimap Spine
Surgimap Spine is a medical device with a measuring function. The limit of accuracy was evaluated using a DICOM image containing generic shapes (ie lines) of know dimension and location. The accuracy or linear and angular measurements has been evaluated to:
|
Measurement Type |
Unit |
Mean Error |
Standard Deviation |
Precision
Estimator |
|
Distance |
mm |
-0.3 |
0.8 |
± 1.6 |
|
Angle |
degrees |
0.0 |
0.2 |
± 0.4 |
FDA
Surgimap Spine is authorized for primary diagnostic.
EC Directive
0123 This device complies with the
Requirements of the 93/42/EEC Directive Concerning Medical Devices, as amended
by Council Directive 2007/47/EC.
Nemaris Inc.
306 E 15th Street, Suite 1R
New York NY, 10003, USA
Phone: +1 800 604 0217 Fax: +1 646 602 6925
Nemaris Inc. has retained the services of MDSS GmbH. Their contact information is:
MDSS GmbH,
Schiffgraben 41
30175 Hannover
Germany
Authorized representative in Australia
Nemaris Inc. has retained the services of Emergo. Their contact information is:
Australian Sponsor:
Emergo Australia
Level 20
Tower II, Darling
Park
201 Sussex Street
Sydney, NSW 2000
Australia
Contents
Copyright and Trademark Notice
Limit of Accuracy for Surgimap Spine
Surgimap Spine is authorized for primary diagnostic.
Legal Manufacturer:
Surgimap Spine is:
Authorized representative in Europe
Authorized representative in Australia
Chapter
1: Welcome to Surgimap Spine
Introduction to Surgimap Spine
Chapter
2: Installing and upgrading Surgimap Spine
Getting Surgimap from www.surgimap.com
Running Surgimap from a preloaded USB key
Chapter
3: Surgimap Spine Guided Tour
Surgimap Spine: Screen by Screen
Detailed Description of Each Function
Detailed description of each Function
Request to be contacted about a specific product
File tree navigation pane (lower left)
Images and file tree manipulation functions
Adjust, select and import images panes
Chapter
7: The Analysis Screen
Current Series navigation pane
Navigate through current series
Thoracolumbar Alignment: TL Align
Tools for modification of annotations & Help Desk
Chapter
8: The Database Screen
Central Pane: Patient and Study table
Editing Patient and Study information
How can I get Surgimap Spine to work on my Mac?
I can’t remember by password/ I lost my password. How
can I get my password reset?
I registered but can’t download the Surgimap Spine
software from the website?
My Surgimap Spine software on the USB stopped working.
What can I do?
The software will not save any images.
I can’t click through to events and sponsored material
I copied Surgimap Spine to a new USB key but nothing
works anymore
Chapter 1: Welcome to Surgimap Spine
Introduction to Surgimap Spine
Thank you for using Surgimap Spine, The Physician Driven Imaging Solution.
Surgimap Spine is a software tool designed to help clinicians, nurses, researchers and ancillary staff to open, manipulate, store, and transport digital images in a user friendly media format (e.g., USB key). This software solution allows for key measurements and surgical case organization to be conducted via intuitive mouse clicks. Use of this software ensures health care professionals that they are using their time efficiently and effectively.
Surgimap Spine was developed by Spine Surgeons, Researchers, and Engineers to function as a stand-alone application that can be run directly off an external storage device (e.g., USB key, external hard drive). The key features and benefits of the software are:
v Universal Image viewer
v Portable Encrypted Database
v Digital Measurement Tools with case simulation
With rising demand for increased efficiency and a market place shift transitioned to digital images, it has become evident that there is need for an image viewer that permits opening a wide range of image formats including DICOM files.
Of course, with image digitization filing cabinet storage is inefficient and as such, Surgimap Spine incorporates a database for the storage of images and associated clinical information. Through unique password protection and encryption technology, information and images stored within the database can be kept confidential.
In addition, with medical images viewed on computer screens there is a need to have the analysis feature for performing measurements and annotating images as well as a surgical simulation feature for interventional procedures.
About this manual
This manual assumes that you know how to use Windows, and have access to digital copies of medical images. For help on these topics, consult your computer owner’s guide or IT department.
Often there is more than one way to select a command in Surgimap Spine. A single command may be available from one of the main menus, from a context-sensitive right click menu, from a toolbar icon, or with a keyboard command. In most cases, this manual gives instructions for selecting commands from toolbar icons. If a toolbar icon has a menu command equivalent, it will be indicated in italic in this manual.
As with any software product there are many ways that the offered tools and features of Surgimap Spine can be used. In addition, the workflow for opening, storing and making annotations to images will vary from user to user and the surrounding work environment. This manual offers general descriptions of features and tools and is organized to demonstrate a common workflow logic. It is not intended to prescribe the order or sequence in which a user should utilize Surgimap Spine.
This manual is applicable to Surgimap version 1.1.2.171 and will be updated from time to time as new versions are released.
Customer Service
The Surgimap Spine website (www.surgimap.com) contains a product overview as well as technical support tips. You can also learn about the various training options or watch our online flash demo to learn how to use Surgimap Spine.
If you are new to Surgimap Spine, our website is the ideal place to get started. After creating your own account you’ll be able to download and use the latest version of Surgimap Spine
How to Contact us
Contact Technical Support at Nemaris Inc. if you encounter problems while using Surgimap Spine. When you contact us, please have a clear description of the problem and know the version of your copy of Windows, as well as the version of your Surgimap Spine copy.
The technical support can be contact as follows:
v Email: support@surgimap.com
v Internet: www.surgimap.com
v Phone: 800.604.0217 (country code is 01)
Request a training
Should you wish to get trained on the use of Surgimap Spine, please do not hesitate to contact our technical support or to file an online request (www.surgimap.com and select the “request a demo” icon). One of our team members will get in contact with you to organize remote online training or meet with you in person during a specific event attended by the Nemaris Inc’s team.
How to determine which version of Surgimap Spine you are using
Simply start Surgimap Spine and make a note of the version indicated on the login screen.
Chapter 2: Installing and upgrading Surgimap Spine
Overview
There are a number of ways for users to obtain the Surgimap Spine software. At a number of conferences and meetings pre-loaded USB keys are distributed. A listing of some of these events can be viewed on our website at www.surgimap.com. In addition, our team can be reached by phone or email regarding inquiries on events (contact@surgimap.com, tel: 800.604.0217). The optimal way of obtaining a version of Surgimap Spine is directly through our website at www.surgimap.com. The advantage of a web download is that it permits immediate registration and thus creation of a password protected version that offers encryption of patient related data.
The current version of Surgimap Spine runs on the Windows operating system. Although compatible with most versions of windows, the possibility for incompatibility with certain version may exist and an updated listing of Windows compatibility can be obtained by directly contacting Nemaris at contact@surgimap.com. Detailed requirements are as follows:
v
Minimum Hardware
Requirements
o Personal Computer
o 256 Megabytes RAM
o 1 GHz CPU or better
o 200 Megabytes free on the Hard Drive
o Keyboard
o Mouse, track ball or equivalent device
o Monitor with a resolution of 1024x768pixels
o USB port (optional but recommended)
v
Software
Requirements
o Microsoft Windows XP SP2 or later
A Mac OS version is currently under development and new releases of Windows operating systems may require users to upgrade their version of Surgimap Spine to ensure compatibility.
Getting Surgimap from www.surgimap.com
Obtaining a version of Surgimap Spine directly from the www.surgimap.com website ensures receiving the latest version of the software. In addition, registration on the site offers the ability to create a unique password and username to benefit from encryption of patient related data. The download process involves several steps from registration to running a simple installer to set up of Surgimap Spine on any desired portable storage medium (USB preferred) or your PC.
From the home screen on www.surgimap.com the first step to downloading a version of the software is to register. This process is simple and quick, requiring only minimal information.
2. To register, simply follow the ‘Download Now’ button on the home screen.
3. Then complete required fields and submit