BIOSmart

Instructions for use

Version 1.2

1
 Table of contents

Introduction 3

Features 4

Installation 5

Using BIOSmart 7

First Steps 7
Main 8
Protocols 9
Patients 11
Patients – Diagnostic 12
Patients – Questionnaire 13
Patients – Exercises 14
Patients – Analysis 15
Customization 16

Options 16
Report Headers 16
Questionnaires 17
Troubleshooting 18

Specifications 19

WirelessEMG Module 19
WirelessEMG Cradle 19
Safety 20

Electrical Safety 20
Handling 20
Battery 20

WirelessEMG Instructions for use 2

Introduction

Thank you for using the BIOSmart from AlbynMedical.

BIOSmart software can be used by its own but its intented to be used with the
Albyn Medical WirelessEMG.

We have made an intuitive software primarying simplicity and usability and we

hope you will enjoy it.

Overview

This is the main interface of the software. From here you can access all the
functionalities of the application.

In the top, there are the main three pats of the application: protocols, patients and
options.

In the left, there are the four actions that you can work with, only when a patient
has been selected.
Features

Easy of use

Actual design

User defined protocols

Checkpoint protocols for easy diagnostic and following

Customizable reports for you hospital information and logos

Installation

BIOSmart is software intended to run in a computer running Windows Vista or up.

If your computer is running Linux, please, contact your local dealer.

BIOSmart software works with the leading insdustry Microsoft Framework and
Microsoft SQL Server. These is the list of prerrequisites your windows must fit.

List of prerrequisites:

Framework 3.5

SQL Server 2005

WirelessEMG Driver

To easier the prerequisites, we have provided you an installation utility. It should

start as soon as the BIOSmart DVD is inserted.

Computers running Windows Vista or up should have the last Framework

installed. In case is not, you can find it in the BIOSmart package or in the
Microsoft website. If you don´t have access to internet in the computer, be sure
the network cable (if any) is unplugged from your computer.

SQL Server must be installed if you didn't installed it before. You can install it from
the BIOSmart package or download it from Microsoft.

The WirelessEMG driver comes with the BIOSmart package and must be installed
once.

After prerrequisites are meet, you can install the BIOSmart software. If you want a
quick install, just click on « next ».
Now, you can start BIOSmart. Click on your Windows Start menu, look for « Albyn
Medical » and click in the BIOSmart icon. You will also find a shortcut in your
desktop. You can safetly delete the desktop icon if you dont like it.
Using BIOSmart

First Steps

Before you can start to use the program you need to recharge the EMG battery.
Plug the cradle to your computer and put the EMG in. Wait for one hour.

After the EMG has been charged, you can start the BIOSmart program.

The very first time, you will see the wellcome page and after a few seconds, this
starting page.

As the EMG is a Bluetooth device, the program needs to know which address the
EMG bluetooth has. If you wait for a few seconds, the program will find the one.
Then you can select it with the mouse, and that address will be tied up to the
program.

There is a field where you must enter the license number asigned to you.

At the end, you should have the SN (serial number), the selected BluetoothID
filled and the license.

Now, you are ready to enjoy BIOSmart. Click on the Patients icon.
Main

There are three main parts: protocols, patients and options.

Protocols

The window is splitted in two areas:

On the left you can see the list of protocols grouped by predefinided and user
defined.

The predefinided are the protocols that we have added and they can't be edited.

The user defined protocols are your own protocols. You can make your own
protocols with a lot of freedom.

To make a new protocol, first, choose the protocol named « 0. new ».

Now you can:

- Write the description you like and click add. The protocol will be added to
the list.

- Import a protocol

After selecting a protocol, you can view, edit or build it, as shown below.
Select the target workload and the duration and click « Add » to add that segment
to the protocol definition.

To make a new stage, just click on the stage that is down the active one, and you
can make another stage.

Remenber to click on the Checkpoint check box if you want this protocol to be
included in the diagnostic reports.
Patients

Here you can manage your patients. As you can see in the left menus, you will
able to handle the diagnostic, the questionnaire, realice exercises to the patient
and analyse the exercise' results. The printing capabilities are in the Diagnostic
tab.

In this first window you can see on the left, the list of patients and, on the right, the
information related to the selected patient on the left.

If you want to add a new patient, select « 1. New » on the tree on the left and fill
the information. Only the name is needed for a new patient.
Patients – Diagnostic

You can introduce here the information you gather about the patient. All fields are
expandable. You will also see a list of all the exercises done to the patient.

Printing:
The printing button allows you to print the History and Diagnostic sections and all
the exercises with the checkbox checked.
Patients – Questionnaire

After choosing the questionnaire you prefer, you can give it to your patient, both in
the screen or printed (clicking on the print button on the top right).

This questionnaire is not binded to the other functionalities of the BIOSmart.

Can be fully customizable to your needs (see section below).

Patients – Exercises

This is the where you can exercise the patient.

At the right side, you can see an icon, that shows the state of the EMG. It should
be green with the status of the battery below. If this icon is red, you can get
information about what is happening, sitting the mouse cursor over the icon.

Once the Emg is propertly running, you can choose the protocol you want the
patient to exercise, and with the controls on the left, you can start the exercise,
pause it, restart the calibration, and stop the protocol.

The exersice is been saved while its running, so it would keep the information if
you suffer an unexpected computer shotdown.

The view of the exercise can be switched between this graphical view and a
pediatric view and viceversa, clicking on the pediatric button at the top left.
Patients – Analysis

The selected patient's exercises are shown in the Analysis area. You will see the
exercises ordered by date and in the botton graph, you can see resumed
information about each exercise.

If you want to print the exercises, you must go to the Diagnostic tab.
Customization

As we know that you want your own customization we have provided BIOSmart
with this ones:

Option window

report headers

questionnaire

You will find a directory, under the BIOSmart application directory, called
UserResources. In there you can find various files. If you change that files
you will get your own customized BIOSmart.

We recommend that you keep a copy of this directory before changing

anything in it, but if lose the files you can allways reinstall the BIOSmart
with the repair option.

Our dealers will help you to tweak this files. But here you have some hints if
you want to tweak it by yourself.

Options

In this window you can find the main options of BIOSmart.

language

Wireless EMG

Minor options

Most of them are self explanatory. The Wireless EMG should be done for one of
our dealers, but as you can see it is so easy as plugging the cradle to the
computer, and, when the EMG module has enough battery and its out of the
cradle, let the BIOSmart find it. When the BIOSmart find it, you must select the
proper bluetooth ID to link BIOSmart to that bluetooth ID.

Report Headers

Report headers are shown when you print the different reports in BIOSmart and
are built up using this 3 files:
 logo1.png

logo2.png

reportHeader.xaml

If you overwrite the logo files with your own corporation files they will be shown in
the reports. logo1.png is intented for the hospital logo and logo2.png is intended
for the department logo. However you can use it the way you like to fit better your
needs.

The reportHeader.xaml file is the file that handles how the header will be shown.
The file its coded in XAML, and you can tweak it the way you want. You don't
need to close BIOSmart to see how its changing, so tweaking it, is easier.

Questionnaires

Questionnaires shown in the questionnaire tab are loaded from the

userResources directory. They are called q.xxx.yy.xaml. Where the first xxx is a
number of your choice (don't repeat or use it for already used questionnaires) and
the yy are the two ISO letters corresponding your country
(http://www.iso.org/iso/english_country_names_and_code_elements).

This files can be fully customized and you can add as many as you like.

If you need any other customization or assistance, don't hesitate asking our
dealers.
Troubleshooting

If you find any problem concerning the BIOSmart – EMG module connection,
follow this guide:

1. Unplug the cradlle

2. Wait a few seconds and plug it again

3. Insert the EMG module in the cradle and let it recharge for at least one hour

4. When you are ready to use the BIOSmart, remove the EMG module from
the cradle and then, start the program.
Specifications

Operating temperature: 15°C to 45°C

StorageTemperature: -40°C to 70ºC
Storage Relative humidity: 10% to 100%
Storage Atmospheric pressure: 700 to 1060 hPa

WirelessEMG Module

Input
1 EMG Channel
2 electrodes, 1 reference electrode.
Patient input protection: ~6kOhms
Input range: 1mV full scale
Input resolution: >100nV (averaged)
Acceptable DC voltage: 600mV maximum
Input impedance: 1010 ohms // 1pF
Input impedance imbalance: >40%
Common mode rejection: >100dB.
Bandwidth: 10Hz~1000Hz
Optional Notch: 50Hz
Input referred noise level: 2µV (averaged)
Communication
Standard Bluetooth® Class II interface.
Fully Bluetooth® V1.1 std. compliant.
Frequency range: FHSS / 2.402 ~2.480
GHz
Radiated RF Power: 2mW (3dBm)
Sensitivity: -85dBm for BER 10-3
Distance range: >20m (depending on
environment).
Analog to Digital Converter
Sampling rate: 2000 samples/second,
Resolution: 24bits (bit weight <30nV)

Power
Estimated battery life:
Lithium-Ion battery pack/ embedded charge
Continuous recording: up to 1 hour.
and protection controller: 3.6V / 560mA
Off cradle, not connected: 30 hours.
On cradle: 3 weeks without recharging.
Charge time 4 to 5 hours for a completely
discharged battery.

WirelessEMG Cradle

Host interface Standard Bluetooth® Class II interface.

Standard USB-B port . Fully Bluetooth® V1.1 std. compliant.
Version 1.1compatible. Frequency range: FHSS / 2.402 ~2.480
Powered by USB port : 5V/130mA GHz
maximum. Radiated RF Power: 2mW (3dBm)
Charger DC supply: 5V / 100mA Sensitivity: -85dBm for BER 10-3
Distance range: >20m (depending on
Communication environment).
Safety

Electrical Safety

Do not use the WirelessEMG with an equipment that is not aproved by Albyn
Medical

Do not make repairs yourself.

Warning: do not attempt to open or disassemble the

WirelessEMG Module and the WirelessEMG Cradle. No
serviceable parts inside.

The Albyn Medical WirelessEMG product is classified in accordance with the EN

60601-1, the standart for Medical Electrical Equipment as follow:

WirelessEMG WirelessEMG
Module Cradle
Internally
Type of electrical protection powered Class II
Equipment

Degree of protection against electrical shock BF B

Degree of protection agaisnt liquids Splash Proof Ordinary

Handling

Your WirelessEMG Module and Cradle may be damaged by improper storage or

handling.

Do not drop your WirelessEMG.

The wirelessEMG Module is not Waterproof, it has been designed to be splash

resistant to liquids.

Battery

Your WirelessEMG module contains a Lithium-Ion battery. If you have problems

with the battery life, ask your local AlbynMedical support service for a
replacement.

Dispose of the WirelessEMG Module / Cradle according to your local

environmental laws and guidelines.
Polígono Industrial Cordovilla
Calle D Nº 1
31191 Cordovilla Navarra
Spain

www.albynmedical.com