Cleveland Medical Devices 0103 QUANTATIVE MOTOR ASSESSMENT SYSTEM User Manual USERS MANUAL 2

Cleveland Medical Devices Inc. QUANTATIVE MOTOR ASSESSMENT SYSTEM USERS MANUAL 2

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USERS MANUAL 2

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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. 1.0
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TABLE OF CONTENTS
Introduction....................................................................................................................... 4
Intended Use ................................................................................................................... 4
Contraindications ........................................................................................................... 4
Warnings ......................................................................................................................... 4
Package Contents and Warranty Information ................................................................ 6
Chapter 1: About ParkinSense........................................................................................ 7
General Device Description ........................................................................................... 7
User Unit......................................................................................................................... 8
Sensors ............................................................................................................................ 9
User Interface Software ................................................................................................ 10
Chapter 2: Setting Up ParkinSense............................................................................... 11
Installing the ParkinSense Program............................................................................. 11
Charging ParkinSense User Unit ................................................................................. 11
Installing the ParkinSense Hardware........................................................................... 11
Starting the ParkinSense Program ............................................................................... 12
Obtaining USB data communication port: ..................... Error! Bookmark not defined.
Chapter 3: About ParkinSense Software...................................................................... 13
Running the Application ............................................................................................... 13
Using the Application ................................................................................................... 13
Accessing the Patient Database.................................................................................... 14
Adding a Patient ........................................................................................................... 14
Updating a Patient........................................................................................................ 15
System Setup.................................................................................................................. 15
Collecting Data Wirelessly Using Bluetooth ................................................................ 18
Starting Data Acquisition ............................................................................................. 19
Acquired Data Display ................................................................................................. 19
Saving Acquired Data ................................................................................................... 19
Stopping Data Acquisition ............................................................................................ 19
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Collecting Data From Memory..................................................................................... 20
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Switching Data Modes .................................................................................................. 21
Erasing Memory............................................................................................................ 21
Reviewing Saved Data .................................................................................................. 22
Printing Current Graph ................................................................................................ 24
Graph Color and Scale Setup ....................................................................................... 25
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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. OPERATION IS
SUBJECT TO THE FOLLOWING TWO CONDITIONS: (1) THIS DEVICE MAY
NOT CAUSE HARMFUL INTERFERENCE, AND (2) THIS DEVICE MUST ACCEPT
ANY INTERFERENCE RECEIVED, INCLUDING INTERFERENCE THAT MAY
CAUSE UNDESIRED OPERATION.
NOTE: THE MANUFACTURERE IS NOT RESPONSIBLE FOR ANY RADIO OR TV
INTERVERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS
EQUIPMENT.
SUCH MODIFICATIONS COULD VOID THE PATIENT’S
AUTHORITY TO OPERATE THE EQUIPMENT.
Contraindications
Interference may occur in the vicinity of equipment marked with the following symbol:
This device complies with CFR 47 – Part 15, 15.109(b) and 15.247.
Warnings
!!!! Do NOT connect the system to a computer via the mini-USB port at the same
time a subject is connected to the electromyography electrode leads.
!!!! Do NOT expose the system to water. Water exposure may permanently damage
the unit.
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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 using a Bluetooth Radio link.
There is a Bluetooth radio embedded inside the ParkinSense unit which will
communicate with a Bluetooth radio connected to your computer. A USB Bluetooth
adapter is provided with the ParkinSense system, however other Bluetooth adapters may
be used.
ParkinSense User’s Guide v. 1.0
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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. If necessary, this information
will allow us to better serve your needs. We highly recommend that you staple a copy of
the sales receipt to the blank pages in the back of this manual.
Please check to make sure your kit has the required components and records the
requested data.
Data of Purchase:___________________________
S/N:_______________________________ (1) ParkinSense Unit
(1) Data Cable, USB
(1) USB Bluetooth Adapter
(1) EMG snap lead cable
(1) Flexible wrist band
(1) ParkinSense software
(1) User’s Guide; this document
ParkinSense User’s Guide v. 1.0
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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). The
wrist module slips over a comfortable band worn around the wrist or forearm. A sensor module
then slips over the middle finger of a subject. ParkinSense provides a total of eight channels of
data including three channels of accelerometry, three channels of gyroscopes, and two channels
of electromyography (EMG). The system measures three dimensional motion using three
orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module. The
system also measures two channels of EMG. The lemo connector input on the wrist module
provides connection for the two channel EMG snap leads which come with the system.
Figure 1. The user unit is worn by the subject and consists of finger and wrist worn components.
Table 1. ParkinSense system specifications.
Sensor Module Size
0.57 x 0.80 x 1.03 in.
Sensor Module Weight
0.7 oz. / 20 g.
Command Module Size
2.88 x 1.56 x 0.66 in.
Command Module Weight
3.25 oz. / 92 g.
Electromyography
Lemo Connector with 5 leads (2
differential EMG leads and one ground)
Wireless Link
Bluetooth™ Radio
Data Transmission Range
~ 20 feet (line of sight)
Data Rate
57.6 kbps, 4800 bytes/s throughput
Transmission Frequency
2.400-2.483 GHz
Transmission Bandwidth
1 MHz
Batteries
Rechargeable Lithium Polymer 850 mAHr
Battery Life
12 Hrs
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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. From left to right. 2Add pictures here to show setup. Fig 2. Wrist
band alone, Fig 3. Sliding over the finger, Fig 4. Sliding over wrist band. Fig 5.
Complete System.
The ParkinSense user unit integrates the following features:
Bluetooth Radio – A Bluetooth Radio is integrated in the ParkinSense system. This provides
real-time data transmission up to a computer with another Bluetooth radio. The transmission
range is 30 feet line of sight.
On Board Memory – In addition to data transmission over the wireless link, data is continually
stored to on board flash memory whenever the system is turned on. The system can store up to
12 hours of data.
Mini USB Connector – The mini USB connector provides a method to directly connect to a
computer with the ParkinSense software installed. This provides three important functions:
- Data download from the user unit memory
- Erasing the user unit memory
- Recharging the user unit battery
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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. This provides data synchronization between the EMG and
the mechanical sensors which are sampled at 128Hz (or every 7.8 milliseconds). (Table 2)
Gyroscopes – The finger worn sensor module includes three orthogonally positioned gyroscopes.
This provides three axes of angular rotation data. (Table 2)
Accelerometers - The finger worn sensor module includes three orthogonally positioned
accelerometers. This provides three axes of linear acceleration data. (Table 2)
Sensors
ParkinSense integrates motion sensing and EMG in a single device. Eight channels of data are
providing including three orthogonal accelerometers, three orthogonal gyroscopes, and two
channels of differential EMG. The exact sensors specifications are shown below (Table 3).
Table 3. ParkinSense system sensor specifications.
Angular Rate
Acceleration
Electromyography
Sensor Type
MEMS Gyroscopes MEMS Accelerometers
Snap electrodes
Number of Channels
3 Orthogonal
3 Orthogonal
2 differential channels
Channels
Channels
Input Range
±1200 deg/sec
±5 g
±5 mV
Min. Freq (3dB)
0Hz
0 Hz
30 Hz
Max. Freq (3dB)
15 Hz
15 Hz
1024 Hz
Input Noise
<1.6 deg/sec RMS
<2 mg RMS
<15 µV p-p
CMRR
N/A
N/A
>60 dB
A/D resolution
12-bit
12-bit
12-bit
Sampling Rates
128 sps
128 sps
2048 sps per channel
DC offset rejection
N/A
N/A
300 mV
Input Impedance
N/A
N/A
>20 Mohm
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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.
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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. Plug the small
end of the USB cable into the ParkinSense User Unit.
3. The green LED should come on, indicating the device is charging.
Installing the ParkinSense Hardware
1. Make sure the device is fully charged before first use.
2. Turn on the ParkinSense User Unit. A series of beeps indicates that the device is on and
ready for wireless data transmission.
3. Install the Bluetooth driver from the disc provided with the Bluetooth unit. Follow the
directions in the package.
4. Plug the Bluetooth Device into an open USB port.
5. Go to your Bluetooth Devices Manager by going to
 < Settings>  < Bluetooth Configuration>
6. Select Bluetooth Wizard, and complete the Wizard process. Select the following services:
File Transfer, Network Access, Bluetooth Serial Port.
7. When the Wizard has completed, double click on My Bluetooth Places. Select the
Bluetooth Setup Wizard, and check the box for “I want to find a specific Bluetooth
device…”
8. Windows will now find all available Bluetooth devices. Double click on Parkinsense.
Figure 3. Add Bluetooth Device Wizard
9. The wizard will now prompt you for a PIN Code for the device. Enter four zero (0000
and click on “Initiate Pairing.” Check “A7 Serial Port.” Click on “Configure.” The port
number will be displayed. Record this number for later use.
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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.
Starting the ParkinSense Program (if it isn’t already active)
1. Click the Start Button
2. Point to Programs
3. Click on ParkinSense
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Chapter 3: About ParkinSense Software
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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.
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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
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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. This will
remove all the patient’s information in the database, as well as the patient’s recorded
data.
To exit the Patient Database, click Exit.
System Setup
From the main screen click on the System Setup button to access the System Setup menu.
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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. Follow the
following step to obtain a Radio port by scanning:
1. Make sure ParkinSense user unit is on and unplugged from the USB data
cable.
2. Click on the “Scan For Ports” button and the status indicator should change from
blank to Scanning…
3. When the status indicator displays “Done!,” use the pull down menu of the
COM Port (Radio) to select the Radio port. When one has more than one
ParkinSense User Unit on, the scan will return the ports of all the devices turned
on during the scan.
To exit System Setup and save the changes that you have made, click on OK.
Patient Test Mode
System Setup allowed you to change the mode of operation of the software, from regular data
acquisition to Patient Test operation. In Patient Test mode, the software will guide the patient
through a series of activities and record those data to the patient’s profiles. To switch to Patient
Test mode, follow these steps:
1. Make sure the proper COM Port (Radio) is setup for wireless data acquisition.
2. Under Patient Test, check the box right next to “Test Mode Enabled”.
3. Click on “Select Test Patient” to select a patient for which the test is perform on
from the drop down menu. After you have selected a patient, click “Load
Patient” button to continue.
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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. To exit out of Patient Test operation mode, simply go back into System Setup and
uncheck the checkbox label as “Test Mode Enabled”.
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Collecting Data
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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.
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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.
By default, there are eight channels visible scaled
at 10 seconds.
To change the axis scales and number of visible
channels, click Channels/Time on the tool bar.
Check the channels you would like to be visible,
and uncheck those channels that you would like to
hide. Chose the time scale most suitable for your application and click OK to save.
Saving Acquired Data
To begin saving the received data, click the Start
Recording button at any time. This will bring up a
window called Enter File Name. Enter a pertinent file
name to save the patient’s data for this trial. After
entering a file name, click Start Saving. This will
begin the recording process.
Stopping Data Acquisition
Click the Stop Data button on the tool bar to end data acquisition. If
data is recording, click Stop Recording to end recording.
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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. Once the patient is loaded, a data screen appears.
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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. Enter in a pertinent file
name to save the patient’s data for this trial. After entering a
file name, click Start Saving. This will begin the transferring
process.
While downloading from memory, you can observe the data
being transferred in the graph area. When the computer has
downloaded all the data from memory, a long beep will indicate
the download process has finished. An “Erase Data” window
will appear asking if you want to erase the memory from the
User Unit. To erase the memory, click “Yes,” otherwise click
“No”. When you click “Yes” to erase the memory on the device, a series of beeps will indicate
that the memory is being erased. The deletion is complete when the beeps stop.
Switching Data Modes
To switch back to wireless data acquisition from USB, you must turn off and remove the USB
cable from the device. When you turn on the device again, you should hear a series of beep
indicating the startup of the device and transition into wireless mode.
To switch to USB data aquisiton from wireless mode, you must first turn on the device. There
will be a series of beeps during the start-up routine. Wait for these to stop, then plug in the USB
data cable into your device. You should hear two beeps after you plug in the cable. The beeps
indicate that the device is switching from wireless mode to USB data mode.
Erasing Memory
While you are in USB data mode, you can erase the
memory at anytime by clicking on “Erase Memory”
button on the tool bar menu. A window dialog appears to
ensure you want to erase the memory. Clicking “Yes”
will continue the process of erasing the memory. A series
of beeps will follow, indicating the memory is erasing.
The process is finished when the beep pattern stops. Clicking “No” will cancel the process.
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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. The data display format
that you are observing is the “Time Graph”. Use the
scroll bar to examine the data. The scroll bar will scroll
across hours/minutes/seconds of the data you collected.
The data you collected can be display in three different formats by using the toolbar menu of
Review Saved Data. The data can be display as time graph, frequency graph, and as power
graph.
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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. The peak frequency is calculated over 30
second windows and plotted in the graph. The image display below is an example of what you
would see when you are in “Frequency Graph” display option.
The data you collected can also be displayed as a Power Graph. To display the data collected as
Power Graph, simply click on “Power Graph” on the toolbar menu. . There’s a brief wait period
before the data can be display as Power 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. An example of what you would see is shown below.
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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.
Printing Current Graph
You can print the current view of the graph display in both “Review Saved Data” and “Collect
Data” window. To print the current graph in “Collect Data” or “Review Saved Data”, simply
click on “Print” on the toolbar menu.
A new window will appear upon clicking on “Print”
called Page Setup. From Page Setup, you can select the
paper size, margins, paper source, and orientation of the
print. After you have selected the pint option, hit OK to
continue.
After you have clicked OK from the previous window, a
new window will appear for you to select a printer of
your choice. The image below is an example of what you
would see. After you have selected the desired printer to
print the graph, click OK to proceed with the printing. To
cancel the print process, click on Cancel of this window.
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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.
Channels / Time
The number of visible graphs and their scales can be
changed in both the Collect Data window and the
Review Saved Data window. To access this menu,
click on the “Channels/Time” button on the toolbar.
This will pull up the Channels/Time Scales window.
Different visible channels and time scale options are
available. The checked the channels will be visible.
Choose your desired visible channels and time scale.
Click “OK” to save your changes and return to the
graph window.
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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. The system will do a scan and return a list of devices found, as well as the associated
ports. Your ParkinSense radio is found in any ports labeled “A7 Serial Port.”
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