Clevemed Proprietary Information Telephone: (216) 791-6720 or Toll-free 1-877-CleveMed (1-877-253-8363)
Clevemed Proprietary Information Fax: E-Mail: Web: 9:00 a.m. - 5:00 p.m. EST Monday - Friday (216) 791-6739 Customer Support: Sales: Mailing Address: Cleveland Medical Devices Inc. 4415 Euclid Avenue, Fourth Floor Cleveland, Ohio 44103 © Cleveland Medical Devices Inc. 2006 ParkinSense User’s Guide v. 1.
Clevemed Proprietary Information TABLE OF CONTENTS Introduction....................................................................................................................... 4 Intended Use ................................................................................................................... 4 Contraindications ........................................................................................................... 4 Warnings ..........................................................
Collecting Data From Memory..................................................................................... 20 Clevemed Proprietary Information Switching Data Modes .................................................................................................. 21 Erasing Memory............................................................................................................ 21 Reviewing Saved Data ...........................................................................................
Clevemed Proprietary Information Introduction Intended Use ParkinSense is not FDA cleared to market. It is not intended for use in experimentation that involves human testing without specific IRB approval. The ParkinSense movement disorders quantification system is intended for use by researchers analyzing quantitative features of movement disorders which require recording motion and/or electrical activity of muscle. THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES.
Clevemed Proprietary Information Minimum System Requirements Personal computer with Pentium III™ 500 MHz or higher processor (or equivalent); Microsoft® Windows 98/NT 4/2000/XP; 256 MB of installed memory; Minimum 500 MB free hard disk space (1 GB recommended); CD-ROM Drive; 1024x768 or greater display resolution; Mouse or other pointing device; One USB port Bluetooth™ Radio (Included with ParkinSense kit, however other Bluetooth adapters may be used) The ParkinSense system communicates with your computer
Clevemed Proprietary Information Package Contents and Warranty Information Cleveland Medical Devices Inc. thanks you for your recent product purchase. CleveMed offers phone technical support (9 AM-5 PM EST) and warrants the ParkinSense (parts and labor) for 90 days from the date of purchase. Technical support after the 90 day period will be charged hourly. Call CleveMed for hourly rates. For your benefit, we recommend that you record the pertinent details below.
Clevemed Proprietary Information Chapter 1: About ParkinSense General Device Description The ParkinSense movement disorder assessment system can be utilized for a wide variety of applications to quantify motion and electrical muscle activity. The system includes a user worn unit, a radio for wireless data transmission, and software to collect, manage, and analyze data. The ParkinSense user unit is typically worn on the wrist and finger of a subject (Figure 1).
Clevemed Proprietary Information User Unit The user unit (Figure 1) is worn by the subject and consists of two parts connected by a thin, flexible grey cable. To put the user unit on, the subject should first slip the thin, flexible wrist band over their forearm just below their wrist. Next, the sensor module of the ParkinSense User Unit should be place over their middle finger with the grey cable facing toward the wrist. The clip of the wrist module should then be slid over the wrist band. Figures 2 – 5.
Clevemed Proprietary Information Figure 6. The ParkinSense wrist module includes both a mini USB and lemo connector. Electromyography – The user unit provides a lemo connector input for two channels of electromyography (EMG). The electromyography data transmitted over the wireless link and saved in memory is processed data. The user unit samples EMG at 2 KHz. However, the root mean square (RMS) value of the EMG signal is processed every 7.8 milliseconds and stored to memory or sent over the wireless link.
Clevemed Proprietary Information Accelerometer - axis Add a picture here to show the orientation of the sensors. (Fig 7) User Interface Software ParkinSense user interface software provides several functions including: - Real-time data display Saving real-time data to file Patient database and file management Saved data review Downloading data from the user unit Erasing the memory of the user unit Frequency analysis of saved data files The software is explained in greater detail in Chapter 3.
Clevemed Proprietary Information Chapter 2: Setting Up ParkinSense Installing the ParkinSense Program 1. 2. 3. 4. Insert the ParkinSense installation CD-ROM into your computer’s CD-ROM drive. Double-click on the ParkinSense Installer program. Follow the on-screen prompts to install the software. Once the software has been installed, start the ParkinSense software. Charging ParkinSense User Unit 1. Locate the ParkinSense User Unit. 2. Plug the large end of the USB data cable into your computer’s USB port.
Clevemed Proprietary Information 10. After the device is installed, the wizard will display the new port assigned to your device. The new port for your device is label as “A7 Serial Port on Parkinsense:” 11. Go to “My Bluetooth Places.” Double click on “A7 Serial Port on Parkinsense:”The icon will light up and the port will be displayed. Note : When using an external Bluetooth device, attaching the USB Bluetooth device to a different USB port will change the radio port of your ParkinSense User Unit.
Chapter 3: About ParkinSense Software Clevemed Proprietary Information Running the Application When the ParkinSense Data Collection Package has been installed, it can be run from the Windows Start menu. Click Start Programs ParkinSense Using the Application Once the program is running, a main menu will appear. Figure 7. The ParkinSense Main Menu From this menu, the patient database can be accessed, new data can be collected, and old data can be reviewed. To exit the program, click the Exit button.
Clevemed Proprietary Information Accessing the Patient Database To access the patient database, click on the Patient Database button. The following menu is displayed. The Patient Database stores all patients’ personal information, as well as their data results. Figure 8. Patient Database In the patient database, the user can: Add a patient Update a patient’s information Remove a patient from the database Adding a Patient ParkinSense User’s Guide v. 1.
Clevemed Proprietary Information To add a patient, fill in the necessary information into the text boxes. Once complete, click on the Add Patient button to submit the information. Updating a Patient To change a patient’s information in the database, click on the patient’s name on the database list. Change the necessary data, and then click Update Patient. Removing a Patient Highlight a patient’s name on the Patient List. Then click Remove Patient.
Clevemed Proprietary Information The System Setup menu allow you to set up the proper ports for wireless and USB data acquisition between the ParkinSense user unit and the software package. COM Port (Radio): This is the port required for wireless data acquisition via Bluetooth. Enter the port obtained during the ParkinSense User Unit setup here. It can also be detected automatically by doing a Scan. Scan For Radio Ports This function allows you to scan for COM Port (Radio) of a ParkinSense User Unit.
Clevemed Proprietary Information 4. At the main screen of System Setup, click OK to save the changes you have made. 5. You will now return to the main screen of the ParkinSense Software, hit the space bar to begin the Patient Test. On screen direction will guide you through a set of activities, while recording the result acquired from these activities in the patient ID folder. 6.
Collecting Data Clevemed Proprietary Information Collecting Data Wirelessly Using Bluetooth Make sure that you have set up the proper port setting in System Setup before you start collecting data. Click on the “Collect Data” button to open the data collection mode. A window will pop up to Load a Patient. Use the pull down menu to choose the correct patient, then click Load Patient. Once the patient is loaded, the data screen appears. ParkinSense User’s Guide v. 1.
Clevemed Proprietary Information Starting Data Acquisition To begin data acquisition, ensure the ParkinSense arm device is switched to ON, and click Start Data on the tool bar. When communication with the ParkinSense arm device is established, data will begin scrolling across the graph display. Acquired Data Display The graph area of the “Collect Data” window in ParkinSense Research ToolBox displays real-time data as it is acquired by the User Unit and transmitted to the PC.
Clevemed Proprietary Information Collecting Data From Memory When the ParkinSense User Unit is on, the device immediately starts recording data to its internal memory. To download data from this memory at anytime, go through the following steps. 1. From the main screen, click on the Collect Data button to open the data collection mode. 2. A window will pop up to Load a Patient. Use the pull down menu to choose the correct patient and click Load Patient. 3.
Clevemed Proprietary Information Make sure that you have setup the proper port setting in System Setup before you start downloading data from memory. Begin by turning on your ParkinSense User Unit. While the ParkinSense User Unit is on, plug the large end of the USB data cable into your computer’s USB port. Plug the small end of the USB cable into the User Unit. Click the Download Memory button to start downloading the data from memory into your desktop. This will bring up a window called Enter File Name.
Clevemed Proprietary Information Reviewing Saved Data Saved data can be reviewed at a later time by clicking the “Review Saved Data” button. Clicking this will bring up a Load Patient window. Use the pull down menu to find the patient’s name and then click Load Patient. After clicking Load Patient, a second window appears prompting you to select a file. Choose the file to review and click “Analyze.” After indicating the file to be reviewed, the recorded data will appear for analysis.
Clevemed Proprietary Information To view the data you collected as frequency graph, simply click on “Frequency Graph” of the toolbar menu. There’s a brief wait period before the data can be display as frequency graph. The wait period depend on how much data is to be processed. For 12 hours of data, the expected wait time would be around 1.5 minutes to 3 minutes. In “Frequency Graph” display format, you can scroll across hours/minutes/seconds to view the peak frequency of the subject’s movement over time.
Clevemed Proprietary Information Once your data is processed for “Frequency Graph” or “Power Graph”, you can switch between the three display formats without processing the collected data again. You can use the toolbar menu to switch between Time Graph, Frequency Graph, and Power Graph. If you exit “Review Saved Window”, your data will have to be processed again for “Frequency Graph” and “Power Graph”, the next time you use these functions. To exit Review Saved Data window, click on Exit on the toolbar.
Clevemed Proprietary Information Graph Color and Scale Setup The graph color and scale can be changed in both the Collect Data window and the Review Saved Data window. To access this menu, click on the graph title button to the right of the graph. This will bring up the Color and Scales window. Different color and scale options are available. Click on the desired color or scale number, and then click “OK” to return to the data window.
Clevemed Proprietary Information Miscellaneous Information: Obtaining a Bluetooth port manually: 1. Turn on the ParkinSense User Unit. A series of beeps indicates that the device is on and ready for wireless data transmission. 2. Plug the Bluetooth Device into the USB port 3. Go to your blue tooth Devices Manager by going to Start Control Panel Bluetooth Devices 4. Double click on Bluetooth Devices to enter the Bluetooth Devices Manager. 5. From here, click on COM Ports tab at the top. 6.
Clevemed Proprietary Information ParkinSense User’s Guide v. 1.
