Cleveland Medical Devices 0087 Low noise patient monitoring system User Manual USERS MANUAL

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Document Description	USERS MANUAL
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Date Submitted	2004-11-22 00:00:00
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CleveMed Proprietary Information
CleveMed Proprietary Information
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Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
Chapter 1: About BioRadio 150
General Device Description:
BioRadio 150 (Figure 1) is a wireless data acquisition system capable of recording
multiple physiological signals from users in real time. Using sophisticated wireless and
miniaturization technologies, the BioRadio 150 provides physiological data acquisition
that is untethered thus allowing the users to move freely while monitoring their own
physiological signals on the PC. The BioRadio 150 system can be standalone or may
accompany a number of application programs that are developed by CleveMed for
specific research and education applications (if purchased with the BioRadio 150, details
of the application software will be described separately).
Figure 1. BioRadio 150
system
Antenna
Snap Electrode that measures
EKG (one example of external
sensors that plug into the
User Unit)
BioRadio
Capture Lite
software
User Unit
Antenna
Computer
Unit
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
BioRadio 150 consists of two hardware components (User Unit and Computer Unit) and
a software component (BioRadio Capture Lite). The User Unit is carried by the person
(on the belt) and is responsible for acquiring the physiological signals from sensors
attached on the body. The User Unit processes the physiological signals and wirelessly
transmits it to the Computer Unit using CleveMed’s proprietary telemetry protocol. The
Computer Unit receives the data from the User Unit and forwards it to a PC. The
BioRadio Capture Lite software displays and stores the data on the PC.
User Unit (Figure 2):
The User Unit has a total of 12 acquisition channels.
It acquires data from up to 11 external physiological sensors (placed on the User’s body)
and from one internal sensor that measures motion or position of the User Unit itself.
The User Unit incorporates state-of-the-art wireless technology in the Industrial Scientific
Medical 902 – 926 MHz (ISM) band. The User Unit is battery powered (2 AA) that lasts
for at least 12 hours continuous use. The User Unit is turned on / off with a toggle switch
located on the side of the enclosure.
11 external sensors: The eleven external sensors can be placed on various locations on
the body to sense various types of physiological signals. The eleven external sensors can
be further divided into four categories of sensors:
Category 1: 8 biopotential signals such as Electroencephalogram (EEG), Electromyogram
(EMG) and Electrocardiogram (ECG). Figure 1 illustrates an example where 4
bioptential signals are connected to the User Unit: 2 EMG (arms), 1 ECG (chest), 1 EEG
(head).
Category 2: 1 oxygen saturation sensor (SpO2).
Category 3: 1 airflow sensor (differential).
Category 4: 1 auxiliary DC input.
The first category of sensors, biopotential sensors, are off-the-shelf electrodes such as
snap-type electrodes or gold cup electrodes that attach to the body on one end and plug
directly into the User Unit on the other end (Figure 1). The second category, oxygen
saturation sensor, is specific to the BioRadio 150 system and wraps on the User’s index.
The airflow sensor uses off-the-shelf nasal cannula that can monitor the User’s breathing.
The last category of external sensors, Auxiliary DC, can be used to hookup to other
monitors such as blood pressure monitors capable of producing an analog output voltage
(0-2 V).
The internal position sensor can be used to sense the position or
1 Internal Sensor:
movement of the User Unit; therefore the internal sensor can be used to detect the
movement of the USER provided the User wears the User Unit (as shown in Figure 1).
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
Airflow inputs
(differential)
Antenna
Oxygen
Saturation
input
Aux. DC
input (not
seen in picture
but located
underneath
the patient
Gnd
connector)
CH 1 +,- to
CH 8 +,Used for
differential
biopotential
inputs.
Patient
Gnd
connection
Figure 2. The BioRadio 150 User unit.
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
Computer Unit (Figure 3): The Computer Unit is a smaller device that plugs
into the USB port of any PC. As mentioned earlier, the Computer Unit is responsible for
receiving the data from the User Unit, demodulates it and sends it to the PC. Similar to
the User Unit, the Computer Unit contains a radio transceiver that operates in the 900
MHz ISM band. The Computer unit is powered from the PC and thus has no external
power supply. Also, the Computer Unit has no On/OFF switch or any other user
accessible parts. Once plugged into the PC, the Computer Unit is automatically detected
by the PC and awaits for data from the User Unit.
Antenna
USB
connection
to PC
Figure 3. BioRadio 150 Computer Unit
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
BioRadio Capture Lite:
BioRadio Capture Lite is a basic data acquisition and display software offered with
BioRadio 150 (Figure 4). The program has a sub-menu on the right-hand side of the
screen that provides information about the device and the data as well as allows the user
to select basic functionality. Under the Control sub-menu (Figure 4) the software allows
the user to Start and Stop acquisition, change display update rate, and to Save the data.
The Device sub-menu displays the name of the device that is connected to the PC
(BioRadio 150) and the COM port name used for the connection. Additionally, the
Device sub-menu allows the user to change the sampling rate (100 Hz to 960 Hz per
channel) and change the transmission frequency from channels 1 through 85. The Signal
sub-menu provides feedback to the User regarding the fidelity of the acquired signal
(good packets is a measure of error free signal received from the User Unit, Bad packets
is a measure of received but corrupted packets, Dropped packets is a measure of data lost
due to interference. As mentioned earlier, specific application software maybe
purchased.
Figure 4. BioRadio Capture Lite software
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
Minimum System Requirements
Personal computer with Pentium III™ 500 MHz or higher processor (or equivalent);
Microsoft® Windows 98/NT 4/2000/XP;
64 MB of installed memory;
Minimum 500 MB free hard disk space (1 GB recommended);
CD-ROM Drive;
SVGA 256-color or higher resolution video adapter;
Mouse or other pointing device;
One free USB port
The Computer Unit communicates with your computer through a standard USB port.
Intended Use
The Bioradio 150 is intended for monitoring and recording of physiological signals to aid
in research and/or diagnostic purposes.
This device is not intended for use as life support equipment such as vital signs
monitoring in intensive care units.
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 MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV
INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS
EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY
TO OPERATE THE EQUIPMENT.
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
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 15.249.
Such interference could be caused by the use of multiple BioRadio 150 units operating in
the same vicinity. If you purchase multiple units please notify Cleveland Medical
Devices Inc. at the time you place your order so that each of your units may be
programmed to different frequencies.
Warnings
Improper routing of leads may result in a chocking hazard.
Do not use in conjunction with a defibrillator
Cleveland Medical Devices, Inc.
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
CleveMed Proprietary Information
Package Contents and Warranty Information
Cleveland Medical Devices Inc. thanks you for your recent product purchase. 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 record the requested
data:
S/N: __________________
S/N: __________________
Ver: __________________
CD)
User Unit
Computer Unit
USB data cable (3 feet)
Sensors packet: Snap-On electrodes (45), Snap-On
leads (6), EEG leads (5)
Two AA alkaline batteries
BioRadio ® Capture Lite Installation Software (1
User’s Guide, this document
Date of Purchase: ____________
Cleveland Medical Devices, Inc.
10
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com
Chapter 2: Setting Up the BioRadio 150
Installing the BioRadio Capture Lite Program
1. Insert the BioRadio Capture Lite installation CD-ROM into your computer’s CDROM drive
2. Double-click on the BioRadio Capture Lite Installer program
3. Follow the on-screen prompts to install the Software
4. Once the software has been installed, start the BioRadio Capture Lite Software
Starting the BioRadio Capture Lite Program
•
•
•
•
Click on the Start Menu
Point to Programs
Point to the BioRadio Capture Lite folder
Click on BioRadio Capture Lite
The software is ready to be used. When the hardware hookup is done, you can start data
acquisition by pressing the Start button.
Installing the BioRadio 150 Hardware
1. Remove User Unit and Computer Unit from Starter Kit case.
2. Insert 2 AA batteries in the User Unit. Turn on the BioRadio 150 to make sure the
green LED lights indicating that the device has not been damaged during shipping.
Turn off.
3. Attach sensor(s) to the body. Many sensors can be used with the BioRadio 150. The
starter kit comes with EEG and EKG types of sensors. Final choice of the sensors
depends on the User’s application.
4. Plug in the sensor lead wire into one of the User Unit ports (check chapter 1 – User
Unit) and turn the device ON. The green LED should come on. If the LED is
flashing then the batteries are not new and need replacement.
5. 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 Computer unit.
6. The system is ready for use.
Cleveland Medical Devices, Inc.
11
4415 Euclid Avenue, Cleveland, Ohio 4415 , tel: 1-877-clevemed, www.clevemed.com

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Keywords                        : CleveMed, Proprietary, Information

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