bioradio 150 users guide.pdf

8/11/2019 BioRadio 150 Users Guide.pdf

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Cleveland Medical Devices, Inc. 1-877-CleveMed2

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

Fax: (216) 791-6739

E-Mail: Customer Support: [email protected] Sales: [email protected]

Web: http://www.CleveMed.com

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

EMERGO EUROPEMolenstraat 152513 BH, The Hague

The NetherlandsPhone: +31-70-345-8570Fax: +31-70-346-7299

392-0013 Rev. EDCO 901

Cleveland Medical Devices Inc. 2011


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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


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Intended Use

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

THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES. OPERATIONIS SUBJECT TO THE FOLLOWING TWO CONDITIONS: (1) THIS DEVICE MAYNOT CAUSE HARMFUL INTERFERENCE, AND (2) THIS DEVICE MUST ACCEPT ANY INTERFERENCE RECEIVED, INCLUDING INTERFERENCETHAT MAY CAUSE UNDESIRED OPERATION.

NOTE: THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO ORTVINTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THISEQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USERS AUTHORITY TO OPERATE THE EQUIPMENT.

Contraindications

Interference may occur in the vicinity of equipment marked with the followingsymbol:

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 systemsoperating in the same vicinity.

Warnings

Improper routing of leads may result in a choking hazard.

Do not use in conjunction with a defibrillator.


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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) RAM1024 X 768 or greater display resolutionOne available USB 2.0 port1GB or more available Hard Disk space Microsoft compatible keyboard and mouse or other pointing device Adobe ReaderWindows compatible inkjet or laser printerCD-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 theBioRadio 150 (parts and labor) for one year from the date of purchase.Technical support after the warranty period will be charged hourly. CallCleveMed for hourly rates. For your benefit, we recommend that you record thepertinent details below. If necessary, this information will allow us to better serveyour 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 therequested data:

S/N: ___________Device ID:_______ User UnitS/N: ___________Device ID:_______ USB Receiver

Test PackUSB data cable (3 feet)Snap-On leads (4 pk)Two AA alkaline batteries

Users Guide, this document

Date of Purchase: ____________


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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 150provides physiological data acquisition that is untethered thus allowing subjectsto 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 USBReceiver. The User Unit is worn by the person and is responsible for acquiringthe physiological signals from sensors attached on the body. The User Unitamplifies, samples, and digitizes the physiological signals and wirelesslytransmits them to the USB Receiver. The USB Receiver connected to a USBport receives the data and forwards it to the PC for display and analysis.

User Unit

USB Receiver

Antenna

SnapElectrodes


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User Unit

The User Unit (Figure 2) has a total of 12 acquisition channels. It acquires datafrom up to 11 external physiological sensors and from one internal position

sensor that measures motion or orientation of the User Unit itself. The User Unitincorporates wireless technology in the 2.4 2.484 GHz band. The User Unit ispowered by two AA batteries for a minimum of 12 hours. The User Unit is turnedon / off with a toggle switch located on the side of the enclosure. A green lightindicates when the Unit is on.

Sensors

11 external sensors: The eleven external sensors can be placed on variouslocations on the body to sense various types of physiological signals. The elevenexternal 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 electrodessuch as snap-type electrodes or gold cup electrodes that attach to the body onone end and plug directly into the User Unit on the other end (Figure 1). Thesignals 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 theUser Unit: 2 EMG (arms), 1 ECG (chest), 1 EEG (head). The user has thecapability to configure the BioRadio 150 data acquisition hardware to bestcapture the various physiological inputs, such as AC-DC coupling, input rangesand sampling frequencies.

The second category, oxygen saturation sensor, is specific to the BioRadio 150system 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 othermonitors, such as blood pressure monitors, capable of producing an analogoutput voltage (0-2 V).

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


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Airflow inputs(differential)

On/Off Switch

Antenna

Auxiliary DCinput (not shown,underneath theGND connector)

Patient Ground

Figure 2. The BioRadio 150 User Unit.

H 1 +,- to CH 8 +,-Channels for differentialiopotential inputs.

OxygenSaturationinput


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USB Receiver

The USB Receiver (Figure 3) plugs into the USB port of any PC. The USBReceiver 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 externalpower supply. Also, the USB Receiver has no On/OFF switch or any other useraccessible parts. Once plugged into the PC, the USB Receiver is automaticallydetected 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 isshipped with. It will not communicate with any other USB Receiver. A Device IDnumber printed on each Unit will help the user ensure a match between theUser 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 thesame two letters (AA).

Figure 3. The BioRadio 150 USB Receiver.

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