BioRadio

150
Users Guide



Cleveland Medical Devices, Inc. 1-877-CleveMed
2





Telephone: (216) 791-6720 or Toll-free 1-877-CleveMed (1-877-253-8363)
9:00 a.m. - 5:00 p.m. EST
Monday Friday

Fax: (216) 791-6739

E-Mail: Customer Support: support@CleveMed.com
Sales: sales@CleveMed.com

Web: http://www.CleveMed.com



Cleveland Medical Devices Inc.
4415 Euclid Avenue, 4
th
Floor
Cleveland, Ohio 44103



EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31-70-345-8570
Fax: +31-70-346-7299




392-0013 Rev. E
DCO 901


Cleveland Medical Devices Inc. 2011



Cleveland Medical Devices, Inc. 1-877-CleveMed
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TABLE OF CONTENTS

Intended Use ................................................................................................................... 4
Contraindications ............................................................................................................ 4
Warnings ......................................................................................................................... 4
Minimum System Requirements ..................................................................................... 5
Package Contents and Warranty Information ................................................................. 5
Chapter 1: About BioRadio 150 ......................................................................................... 6
General Device Description ............................................................................................ 6
User Unit ......................................................................................................................... 7
Sensors ............................................................................................................................ 7
USB Receiver .................................................................................................................. 9


Cleveland Medical Devices, Inc. 1-877-CleveMed
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Intended Use

The BioRadio 150 is not FDA cleared to market. It is not intended for use in
experimentation that involves human testing without specific IRB approval.


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 USERS
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), 15.249 and 15.247.
Such interference could be caused by the use of multiple BioRadio 150 systems
operating in the same vicinity.

Warnings


Improper routing of leads may result in a choking hazard.

Do not use in conjunction with a defibrillator.


Cleveland Medical Devices, Inc. 1-877-CleveMed
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Minimum System Requirements

Windows XP Pro (32 bit), Windows Vista Business or Windows 7 Ultimate
Intel Core 2 Duo 6300 1.86GHz CPU (or equivalent)
1GB (2GB for 64-bit systems) RAM
1024 X 768 or greater display resolution
One available USB 2.0 port
1GB or more available Hard Disk space
Microsoft compatible keyboard and mouse or other pointing device
Adobe Reader
Windows compatible inkjet or laser printer
CD-ROM Drive**

* Product performance may vary based on your system configuration.
**A CD-ROM Drive is not necessary if using the electronic delivery method of software
installation.

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
BioRadio 150 (parts and labor) for one year from the date of purchase.
Technical support after the warranty 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 record the
requested data:

S/N: ___________Device ID:_______ User Unit
S/N: ___________Device ID:_______ USB Receiver
Test Pack
USB data cable (3 feet)
Snap-On leads (4 pk)
Two AA alkaline batteries
Users Guide, this document

Date of Purchase: ____________


Cleveland Medical Devices, Inc. 1-877-CleveMed
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Chapter 1: About BioRadio 150
General Device Description

BioRadio 150 is a wireless data acquisition system capable of recording,
displaying, and analyzing twelve 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 subjects
to move freely while monitoring their own physiological signals on the PC.


Figure 1. The BioRadio system.

The BioRadio 150 consists of two hardware components: the User Unit and USB
Receiver. The User Unit is worn by the person and is responsible for acquiring
the physiological signals from sensors attached on the body. The User Unit
amplifies, samples, and digitizes the physiological signals and wirelessly
transmits them to the USB Receiver. The USB Receiver connected to a USB
port receives the data and forwards it to the PC for display and analysis.
User Unit
USB Receiver
Antenna
Snap
Electrodes


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User Unit

The User Unit (Figure 2) has a total of 12 acquisition channels. It acquires data
from up to 11 external physiological sensors and from one internal position
sensor that measures motion or orientation of the User Unit itself. The User Unit
incorporates wireless technology in the 2.4 2.484 GHz band. The User Unit is
powered by two AA batteries for a minimum of 12 hours. The User Unit is turned
on / off with a toggle switch located on the side of the enclosure. A green light
indicates when the Unit is on.

Sensors

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: Eight (8) configurable biopotential signals.
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
signals that can be recorded include, but are not limited to, the
Electroencephalogram (EEG), Electromyogram (EMG) and Electrocardiogram
(ECG). Figure 1 illustrates an example of 4 biopotential signals connected to the
User Unit: 2 EMG (arms), 1 ECG (chest), 1 EEG (head). The user has the
capability to configure the BioRadio 150 data acquisition hardware to best
capture the various physiological inputs, such as AC-DC coupling, input ranges
and sampling frequencies.

The second category, oxygen saturation sensor, is specific to the BioRadio 150
system and wraps on the Users finger.

The airflow sensor uses an off-the-shelf cannula to monitor the Users breathing.

The last category of external sensors, auxiliary DC, can be used to connect other
monitors, such as blood pressure monitors, capable of producing an analog
output voltage (0-2 V).

1 Internal Sensor: The internal position sensor can be used to sense the
orientation or movement of the User Unit. By wearing the User Unit the internal
sensor can be used to detect movement of the User (as shown in Figure 1).


Cleveland Medical Devices, Inc. 1-877-CleveMed
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Airflow inputs
(differential)
On/Off Switch
Antenna
Auxiliary DC
input (not shown,
underneath the
GND connector)
Patient Ground
Figure 2. The BioRadio 150 User Unit.

CH 1 +,- to CH 8 +,-
Channels for differential
biopotential inputs.
Oxygen
Saturation
input


Cleveland Medical Devices, Inc. 1-877-CleveMed
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USB Receiver

The USB Receiver (Figure 3) plugs into the USB port of any PC. The USB
Receiver is responsible for receiving the data from the User Unit and sending it to
the PC. The USB Receiver is powered from the PC and thus has no external
power supply. Also, the USB Receiver has no On/OFF switch or any other user
accessible parts. Once plugged into the PC, the USB Receiver is automatically
detected by the PC and waits for data from the User Unit.

User Unit / USB Receiver match Device ID

The User Unit is assigned or matched to a specific USB Receiver that it is
shipped with. It will not communicate with any other USB Receiver. A Device ID
number printed on each Unit will help the user ensure a match between the
User Unit and the USB Receiver. The Device ID on the USB Receiver is a two
letter ID (such as AA). The Device ID on a matched User Unit consists of the
same two letters (AA).






Figure 3. The BioRadio 150 USB Receiver.