user manual

english
version 1.0.0
Document Number : EREMB-01200-00
Published: February 2014
Copyright © 2010 - 2014 BTS SpA. All Rights Reserved.
 contents

contents 1
icons, symbols and acronyms 3
radio regulation 7
disposal (WEEE) 8
intended use 9
regulatory label 10
receiving unit regulatory label 10
EMG wireless probes regulatory label 10
AUX wireless probes regulatory label 11
BTS charger regulatory label 12
warnings 13
copyright 16
introduction 17
general description 17
case contents 18
system components 21
receiving unit 21
wireless EMG probes 22
wireless FSW/EGN probes (optional) 25
on-off analysis (optional) 27
electrogoniometers (optional) 29
charger 30
installation 33
user PC minimum configuration 33
connections 33

BTS Bioengineering 1
 contents

description of the software on the user PC 34

BTS EMG-Analyzer configuration check 34
acquisition protocol 37

appendix A – technical specifications 43

wireless probes 43
receiving unit 43
BTS internal coding 44
appendix B – environmental specifications 45
appendix C – power supply and switch off 46
appendix D – battery 47
appendix E – declaration of conformity 48
appendix F – regulatory notice 49
FDA medical device reporting system—reportable events 49
adverse event report (21 CFR 803.32) 50

2 BTS Bioengineering
 icons, symbols and acronyms

Symbol in the instructions for the function.

The icon represents the information which requires special attention.

Symbol in the instructions for the function.

This icon makes reference to a more detailed discussion of the subject in
hand.

Symbol on the equipment:

The data appearing next to the manufacturer’s symbol refer to the place of
manufacture of the equipment itself.

Symbol on the equipment:

The “FCC” symbol refers to the Federal Communication Commission of
the USA. The device complies with the relevant regulations put forth by
the FCC as long as it is operated according to the instructions contained
in this manual and to all national and local regulations.

BTS Bioengineering 3
 icons, symbols and acronyms

Symbol on the equipment:

The figure in the square indicates the insulation class and the part types
used. In accordance with Standard ISO 60601-1, the equipment has an
internal power supply and the parts used are type BF.

Symbol on the equipment:

Attention, read the information in the users’ manual carefully before using
the equipment.

Symbol on the equipment:

The double square indicates that the product is a medical device of II
Class (In accordance with the law EN 60601-1).

Symbol on the equipment:

CE mark with the code of the Notified Body. The CE mark certifies that
the product conforms to the standards applicable in the member states of

4 BTS Bioengineering
icons, symbols and acronyms

the European Union (see Declaration of Conformity).

Symbol on the equipment:

CE mark with the code of the Notified Body. The CE mark certifies
that the product conforms to the Directive 99/05/EEC - R&TTE and
obtained the Expert Opinion by IMQ.

Symbol on the equipment and in the users’ instructions:

Symbol for the separate disposal of electrical and electronic equipment, in
accordance with Directive 2002/96/CE (WEEE).
The equipment belongs to Group 8 (medical equipment).
In force in the nations of the European Union, Norway and Switzerland.

Rx only
Symbol for prescription only. U.S. Federal law restricts this device to sale
by or on the order of a physician or properly licensed practitioner.

BTS Bioengineering 5
 icons, symbols and acronyms

REF
Symbol on the equipment:
Symbol located next to the model number (ref.to catalogue).

SN
Symbol on the equipment:
Symbol located next to the series number on the equipment.

Acronyms used in this manual:

RU Receiving Unit
EMG Electromyography
WS Workstation

6 BTS Bioengineering
 radio regulation

Radio equipment identification:

- EMG probes:
FCC ID: YQH-BTSWEMG2
IC: 9188A-BTSWEMG2

- FSWEGN probes:
FCC ID: YQH-BTSWAUX
IC: 9188A-BTSWAUX

- Receiving Unit contains:

FCC ID: TFB-MATRIXLP
IC: 5969A-MATRIXLP

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.

Modifications not expressly approved by BTS SpA could void the

user’s authority to operate the equipment under FCC rules.

BTS Bioengineering 7
disposal (WEEE)

In disposing of the equipment observe the legal prescriptions.

In accordance with Directive 2002/96/CE (WEEE) all equipment supplied
after 13/08/2005 may not be disposed of in general domestic waste. This
equipment belongs to Category 8 (medical equipment) and is classified in
the Business-to-Business sector.

The symbol of the crossed out rubbish bin

indicates that the equipment must not be
disposed of in normal domestic waste.

The regulations for disposal may differ between

individual countries in the EU. In cases of doubt,
refer to the respective sales outlet.

This is a battery-powered equipment.

See Appendix D for information about the batteries used. Operate

and dispose of this equipment according to the instructions set in
the “warnings” section.

8 BTS Bioengineering
 intended use

This equipment is an instrument for the EMG surface analysis, classified

as medical equipment in accordance with European Directive 93/42/CE
(and its amendments).

BTS FREEEMG 1000 must always be used only for this purpose, by
qualified persons, in an environment suitable for the execution of EMG
analyses and respecting the prevailing regulations in the countries in which
it is being utilized.

BTS Bioengineering 9
regulatory label

Receiving Unit Regulatory label

EMG Wireless Probes Regulatory label

Label on the probes:

Probe ID

10 BTS Bioengineering
regulatory label

Label not on actual probes due to size constraints:

AUX Wireless Probes Regulatory label

Label on the probes:

Probe ID

Label not on actual probes due to size constraints:

BTS Bioengineering 11
 regulatory label

BTS Charger Regulatory label

9V 3A
3A
9V 3A

12 BTS Bioengineering
 warnings

We recommend to carry out any kind of operation keeping

strictly to the security regulations contained in this manual. The
safety of the instrument cannot be guaranteed if these conditions
are not respected.

BTS FREEEMG 1000 is a medical device (EU Directive 93/42/CE and

its amendments, including Directive 2007/47/CE) which use must be at
all times be supervised by qualified and authorized personnel, according to
the laws in force in the nation it is in use. The EMG probes are classified as
ETSI EN 300 440 “Receiver category 3” according to Directive R&TTE
99/5/EEC.
The results of the acquisitions must be assessed by people legally authorised
by national law, who possess the suitable necessary knowledge of anatomy
and muscular function.
The instrument must be used in a medical environment, since it has a high
level of sensitivity (measured voltage levels of between 1 microvolt and 6
millivolt).

The uses of the device for other purposes and with methodologies
different from of those indicated in this manual are not to be
considered congruent with the precise use of the device.

During the preparation of the patient, take particular care that the system’s
components do not impede in any way the normal movements of the
subject. Apply the probes only on undamaged skin.

BTS Bioengineering 13
 warnings

• Only use CE branded probes and hypoallergenic double-sided tape,

compatible with the usage on undamaged skin for brief periods of time
• Periodically verify the integrity of the system and of its components.
• To not wet or dip in water the parts which make up the system.

No modification of this equipment is allowed.

• Only BTS S.p.A. authorized technicians may maintain and operate
servicing to the instrument. BTS S.p.A. cannot be held responsible
for system safety should the instrument be opened, repairs carried out,
third parties software be installed, or system components be replaced by
persons other than those authorized by BTS S.p.A.
• Users cannot change any software configuration (including O.S. and
CD writer software).
• In case the device accidentally falls, tear of the probes or other accidents
always address authorized technical support.
• Use only the provided power supply unit FW7363M/09 (FRIWO) or
the one provided by BTS S.p.A. for supplying the charger unit. If a
different power supply unit is used, the compliance to IEC 60601-1 is
not ensured.
• Only original cables must be used, otherwise BTS S.p.A. cannot assure
the safety of the instrument. Should it be necessary to replace any part
of the system, only original BTS S.p.A. parts may be used.

In addition to the users’ instructions, the prescriptions regarding

accident prevention and technical regulations regarding
occupational safety must also be complied with. The appertaining
national regulations and standards of the country of use, with
regards prevention of accidents and environment, are an extension
of the users’ instructions.

14 BTS Bioengineering
warnings

• Make sure that the cables have been connected correctly. When
disconnecting cables, use the connectors and not the cables themselves
to unplug the connectors.
• Mains plug of external power supply unit is considered as disconnecting
device. Avoid connecting the probes to the charger with inverted
polarity with respect to that shown on the cover of the recharger – This
could cause irreparable damage to them.
• For a safe use and adequate maintenance of rechargeable batteries strictly
follow the instructions given in this manual. If rechargeable batteries
are used in such a way that is not the one specified by BTS S.p.A. the
shelf life, functionality and the integrity of the batteries is not ensured.
• ESD application to EGN probes, causes a loss of link to the device.
Temporary loss of function or performance which is recoverable with
operator action.

BTS FREEEMG 1000 is a device that is able to function

COUNTINUOUSLY, this is of course limited by the battery
duration and by the memory available for the acquisition data
storing.

The device uses lithium ion battery. For the battery replacement
and disposal please contact the technical support. At any rate,
ensure that device component (i.e.) probes, receiving unit, …)
integrity is never compromised.

The information contained in this manual is subject to change

without notice and does not constitute product specifications or
any obligation on the part of BTS S.p.A.

BTS Bioengineering 15
copyright

The software of the system described in this manual is supplied with the
“licence to use” contract. The software may be used or copied only as
stipulated under the terms of this contract.
No part of this manual may be copied or transmitted in any form or
means, electronic or mechanical, including photocopying, without prior
written permission from BTS S.p.A.

Unless otherwise specified, any reference to companies, names, data and

addresses used in the reproduction of the screens and the examples are
purely incidental, and has the sole purpose of illustrating the use of the
BTS product. All trademarks are registered by the respective owners.

This publication contains reserved information which is the

property of BTS S.p.A.
The recipient acknowledges that the illustrations and information
supplied in this manual shall not be made available to third parties
without explicit written agreement by BTS S.p.A.

16 BTS Bioengineering
 introduction

General description
BTS FREEEMG 1000 allows for a functional evaluation and a real-time
visualization of the acquired signals for biofeedback and monitoring
applications.
That makes it an indispensable instrument in the fields of sport,
rehabilitation, ergonomics, neurology and orthopaedics.

With BTS FREEEMG 1000 the patient set up in very quick: the
lightweight probes are attached directly to the pre-gelled electrodes and do
not require any additional fixing such as adhesive tape. Thanks to the total
absence of cables the patient can move around freely.

BTS FREEEMG 1000 is supplied with EMG-Analyzer the most complete

software solution for analyzing electromyographic signals and with BTS
MIOFEED, an easy-to-use therapeutic solution, studied also for home
applications.

BTS EMG-Analyzer software includes predefined templates for evaluations

in the clinical, sports, and research field: Jump, plyometrics, walking,
fatigue analysis, isokinetic, etc...

BTS EMG-Analyzer also has an editor for creating elaboration protocols:

thanks to an innovative object interface, that translates the biomechanical
analysis language into graphical form, the user can develop quickly and
effectively customized analysis protocols.

BTS Bioengineering 17
 introduction

BTS MIOFEED software allows a real-time monitoring of muscular

activations during rehabilitative or sports tests execution.
The EMG signal acquired with BTS FREEEMG 1000 are transmitted
in real-time directly at the receiving unit connected to the PC and
transformed in graphic form and sounds to provide a prompt audio-visual
feedback to the subject. This increase of audio and visual afferences is
fundamental in order to improve the contractile capacities of the muscles.,
also of the paretic ones.

BTS FREEEMG 1000 seamlessly integrates with BTS motion analysis

systems, through the SMART (and ELITE) dedicated software.

Case contents
Standard components:
• Receiving Unit

• Up to 6 wireless EMG probes (identificative labels available in 4 different

colors)

• Magnet for EMG probes activations

18 BTS Bioengineering
introduction

• Probes Charger (AC adapter included)

• Set of disposable electrodes

• USB extension cable

• User manual

Optional components:
• Footswitch Kit
• 2 FSW/EGN Wireless Probes • 2 Connectors of 4 Switches

• 10 single Switches

BTS Bioengineering 19
 introduction

• Electrogoniometer Kit
• 1 FSW/EGN Wireless Probe • 1 Electrogoniometer
• 1 Connector

You will receive the instructions for use for other possible optional
components not mentioned in this manual.

20 BTS Bioengineering
 system components

BTS FREEEMG 1000 system consists of two parts: the receiving unit and
the wireless probes.

Receiving unit

The receiving unit, connected to the PC trough USB, allows the WiFi
reception of the signal acquired by the wireless probes.

The receiving unit is able to handle simultaneously 6 wireless probes with

the following limitations:
• up to 10 EMG probes, used for acquisition of the same number
of electromyographic signals;
• up to 2 probes for the connection of 4 switches each, used for
the basographic acquisition;
• up to 10 probes for electrogoniometers connection, used for
acquisition of up to 2 angle components each;

BTS Bioengineering 21
 system components

All the probe combinations that respect what indicated above are possible.
WiFi
transmission

Wireless EMG Probes

BTS FREEEMG 1000 utilizes miniaturized probes with active electrodes
weighing less than 13 grams.
The special design ensures maximum space-saving and comfort for the
patient who is free to move around without obstacles.
The probes can be hooked on directly to the pre-gelled electrodes without
requiring additional fixing with plasters or double-sided tape.
This together with the total absence of cables enables a much faster patient
preparation, drastically reducing the time of each session.

Each probe consists of a mother electrode and a satellite electrode, each

fitted with a clip. The two parts, connected via a flexible cable, may be
positioned as needed by the user at adjustable distance (electrodes with
variable geometry).

22 BTS Bioengineering
system components

All probes are equipped with a solid state memory buffer, to prevent data
loss for problems due to the WiFi network or due to exceeding the useful
operating range.
1 mother electrode
6
2 LED
3 satellite electrode
1 4 mother electrode clip
5 2 5 satellite electrode clip
3 flexible cable
6
7 probe ID
4 7 5

Each probe is fitted with an LED indicating its state.

The probes can be in one of a number of different states:

• Charge: steady blue LED.
During the recharging phase the steady blue LED is on.
This phase occurs when the probes are connected to the charger
turned on, and the charge level is less than 90%.
When the charge level reaches 90% the led turns OFF.
Since, by connecting a probe to the charger on, it enters in “Deep
Sleep” mode, even while charging the probe will be completely
passive and does not respond to any commands.

• Active-Scanning: white LED which cyclically lights for a few

seconds.
In this mode the probe is searching for the receiving unit.
At intervals of about 1 minutes it carries out a scan of the
frequencies of few seconds. During the scan the white LED
flashes quickly.

BTS Bioengineering 23
 system components

• Active-Connected: white LED which flashes slowly.

When the probe and the receiving unit establish a connection,
the white LED begins to pulse slowly: the probe is waiting for
commands.
If the connection is interrupted, the probe returns to “Active-
Scanning” mode and attempts to re-establish the connection
with the receiving unit.

• Active-Capturing: white LED which lights and goes out at

regular intervals.
During acquisition the white LED flashes at regular intervals of
approximately one second. At the conclusion of the acquisition,
the probe returns to the “Active-Connected” condition.
If during the acquisition, connection to the receiver unit is lost,
the probe continues to acquire, storing the data locally for one
minute and at the same time scans the assigned channel trying
to reconnect to the receiving unit. If after one minute the scan
is unsuccessful, the probe returns to the “Active-Scanning”
condition interrupting the storage of data.

• Completely discharged or in “Deep Sleep” mode: LED is off.

If the probe is completely discharged the LED does not display
any flashing cycle and is off.
The same happens when it is in “Deep Sleep” mode (except
during the recharging phase in witch the led is steady blue).

The probes in “Deep Sleep” mode do not perform any

scan cycle, but are turned off. Is therefore guaranteed
energy savings.

24 BTS Bioengineering
system components

To put the probe in “Deep Sleep” mode it is necessary to connect

them to the Charger switched on, or to put them in contact
with a magnet for half a second.

Before the next use is necessary to reactivate the probes,

putting them in contact with a magnet.

The probes are charged by a dedicated charger to which the probes are
connected via their respective clips.

For more info about the probes charge sse the paragraph “Charger”
of this chapter.

Wireless FSW/EGN Probes (optional)

For collecting the on-off analysis signals coming from the Footswitch or for
collecting data from the Electrogoniometers (optional system components)
BTS FREEEMG 1000 uses wireless probes which must be connected to
the FSW or EGN probes using a special connector.

There are two different kind of probes, please refer to the label on it
to identify the footswitch (labeled FSW) or the electrogoniometer
(labeled EGN) probe.

BTS Bioengineering 25
 system components

The probe consists of a single parallelepiped-shaped block.

The upper face has an ID tag characterized by a color (Green, Red, Yellow,
Blue) and a letter (A, B, C, D, E or F) and a status LED.

The probes can be in one of a number of different states:

• Charge: steady red LED.
During recharging the red LED is on, the probe is completely
passive and does not respond to any command.
When the battery is fully recharged or when the probe is removed
from the charger, if sufficiently recharged it passes to the “Active-
Scanning” mode.

• Active-Scanning: green LED which cyclically lights for a few

seconds.
In this mode the probe is searching for a receiving unit.
At intervals of about 3 minutes for 3 seconds its carries out a
scan of the frequencies.
During the scan the green LED flashes quickly.

• Active-Connected: Green LED which flashes slowly.

When the probe and the receiving unit establish a connection,
the green LED begins to pulse slowly: the probe is waiting for
commands.
If the connection is interrupted, the probe returns to “Active-
Scanning” mode and attempts to re-establish the connection.

• Active-Capturing: Green LED which lights and goes out at

regular intervals.

26 BTS Bioengineering
system components

During acquisition the green LED flashes at regular intervals of

approximately one second.
At the conclusion of the acquisition, the probe returns to the
“Active-Connected” condition.
If during the acquisition, connection to the receiver unit is lost,
the probe continues to acquire, storing the data locally for one
minute and at the same time scans the assigned channel trying
to reconnect to the receiving unit.
If after one minute the scan is unsuccessful, the probe returns
to the “Active-Scanning” condition interrupting the storage of
data.

• Probe discharged: LED is off.

If the probe is completely discharged the LED does not display
any flashing cycle and is off.

The two lateral faces have two connectors; the one on the ID tag side
serves to charge the probe, and a cable will be connected to this to enable
connection to the Charger.

The one on the other side is for the probe connections (FSW or EGN).

Finally, the ID identifier of the probe is on the bottom left corner of the
back side.

On-off analysis (optional)

The Footswitches are useful in defining the contact points during the
contact phases of deambulation.

BTS Bioengineering 27
 system components

The footswitches consist of a resistive membrane, (FSR technology), of

diameter 18 mm and thickness less than 0.5 mm, expressly designed for
applications in the analysis of movement.
The compact size of the instrument permits a maximum of flexibility in
positioning on the patient’s foot.

For applications other than gait analysis, there are available on request
smaller diameter (8 mm) switch probes (applicable, for example, to the
finger), and square (useful for tapping tests), 44 mm x 44 mm.

BTS FREEEMG 1000 permits up to 8 basographic zones to be measured,

through 2 connectors from 4 single switches (usually right and left side)
that are connected to the two FSW wireless probes.

The footswitch channels are supplementary to the 10

electromyographic channels. each FSW probe replace a EMG
probe.

Please refer to § “receiving unit” for the possible probes

combination.

28 BTS Bioengineering
system components

Electrogoniometers (optional)
The Electrogoniometer is an easy to use device that allows the measurement
of joint angle progress over time.

There are primarily two types of electrogoniometers: the potentiometer

and the strain gauge. BTS FREEEMG 1000 uses the strain gauge
electrogoniometer of Biometrics LTD.
There are single-axle models for the neck (axial rotation) and the forearm
(prone-supination) and biaxial models for other main joints: wrist, elbow,
knee, ankle, hip and back.
The strain gauge electrogoniometers are made up of two sensors, connected
to each other, that are fixed to the bone segments involved in the joint to
value.

The measure of the angle is provided by the relative angle between the
axes of the two sensors and, unlike the potentiometric electrogoniometers,
it doesn’t depend on the linear slidings in which the two extremities can
incur.

Each electrogoniometer is connected to a EGN wireless probe using

BTS Bioengineering 29
 system components

the appropriate connector. Each receiving unit can handle up to 10

electrogoniometers.

The EGN channels are supplementary to the electromyographic

ones, each EGN probe replace a EMG probe. Each EGN probe
allows acquiring up to two angular components.

Please refer to § “receiving unit” for the possible probes

combinations.

Charger
The Charger, included with the product, charges the BTS FREEEMG
1000 probes.

The Charger can simultaneously charge up to 8 EMG probes and 2 FSW/

EGN probes.

More units can be connected in series for simultaneous power

supply through the same AC adapter, using the cable included.

30 BTS Bioengineering
system components

The EMG probes are connected to the charger using the same clips that
normally collect the EMG signal.

Refer to the cover of the charger to identify the correct polarity.

The probes cannot be recharged if the polarities are inverted.

The Charger comes with an output short circuit protection

system also in case of reversed recharging poles. At any rate, poles
connected incorrectly will not recharge.

While the FSW/EGN probes connect to the charger using the special
connector as shown in the figure below:

To recharge connect all the probes that you would like to charge to the
Charger (follow the instructions described above) and connect the AC/

BTS Bioengineering 31
 system components

DC adaptor to the mains and turn on the switch located on the rear panel.
When the Charger is properly connected to the mains and has been turned
on, the status LED “Power” will show a steady GREEN light.

The charging status of the EMG probes and of the FSW/EGN

probes is indicated by the respective status LED (see § “Wireless
EMG Probes” and “Wireless FSW/EGN Probes”).

Note that inserting the EMG probes into the Charger when it is
on, these come in “Deep Sleep” mode.
It is necessary to reactivate the probes, prior to use them, using a
magnet.

The Charger is equipped with a Magnet fro the probe activation:

32 BTS Bioengineering
 installation

User PC minimum configuration

Operating system Windows 7
Processor Intel Dual Core
RAM 2 GB
Video resolution 1280x800
Disk space 100 MB for the application,
not including storage for acquired data
USB 2.0

Connections
The wireless probes transmit in real-time the acquired data to the receiver
connected via USB to the Workstation.

Connect the receiver to the WS using the USB connector.

If the morphology of the WS does not allow direct connection of

the receiver, use the USB extension cable.

Also verify that the probes are enough charged and ready for use:

Note that to be recognized and activated by the system it is

necessary that all the probes have been disconnected from the
Charger (if switched-on) and that the EMG probes have been
also reactivated using a magnet.

BTS Bioengineering 33
 installation

Description of the software on the user PC

BTS EMG-Analyzer is the complete and highly flexible solution for
making advanced elaborations of electromyographic signals and angular
measurements of body segments.
Includes predefined templates for evaluations in clinics, sports, and
research and an editor to develop customized elaboration protocols.
In the following paragraph we will refer to this software, however BTS
FREEEMG 1000 is manageable also by BTS MIOFEED software and
all BTS applications of SMART family dedicated to the motion analysis.

For more details concerning the use of BTS FREEEMG 1000

with other software, please refer to its specific manual.

Before to proceed verify that the software BTS EMG-Analyzer has

been properly installed on the user PC (please refer to its manual
for the installation procedure).

BTS EMG-Analyzer configuration check

Keeping the receiver still inserted in the USB port, launch BTS EMG-
Analyzer double-clicking on the relative icon.
If the following windows appears:

34 BTS Bioengineering
installation

Click on “OK” to reach the software main screen. On the menu bar at the
voice “Laboratory” select “Set Emg Device”. The following windows will
open:

Verify that the check is on “EMG embedded”.

The system will automatically detect the port number. In any case it is also
possible to select it manually acting on the drop box menu.
If the port number is the correct one the software will activate the Sensors
area of the windows and all the info about the sensors associated with the
USB receiver connected to the workstation will be visualized.

BTS Bioengineering 35
 installation

Verify that all the parameters values ​​coincide with those reported on the
supplied sensors that you want to use (see § “Wireless EMG probes” and
“Wireless EGN/FSW probes”).

During the acquisition the system will acquire always all the sensors
enable in this windows. To disable the sensors that you don’t need
for the acquisition uncheck them and click on “Update” before
closing the window to save the new configuration.

To enable a sensor click on the white square correspondent.

The check mark will appear. The fields “Serial”, “Label Code” and “Label
Color”,​will be filled with the last memorized values.
If the sensors to be used are different change the correspondent values
according with the values reported on the probes to be used (see § “Wireless
EMG probes” and “Wireless EGN/FSW probes”), and select the “Type”
among “EMG”, “FSW” and “EGN”.

Click on “Update” before closing the window to save the new configuration.

36 BTS Bioengineering
 acquisition protocol

Now we will describe a basic procedure about how to create a new protocol
using BTS EMG-Analyzer software.

Refer to the BTS EMG-Analyzer manual for further details about

the “Protocol builder” function.

The procedure may be different if performed with other

applications. In this case, refer to the specific manual of the
software you are using.

Please note that with BTS FREEEMG 1000 it is possible to acquire up to

10 probes.

Refer to § “Receiving unit” for the details about possible probe

combinations.

Launch the software EMG-Analyzer.

Before to proceed we suggest you to make the procedure described

in the § “Software configuration check” to be sure to have selected
the EMG embedded device and to have enabled all the probes
required for the acquisition.

To create a new protocol, from the menu voice “Laboratory” of BTS

EMG-Analyzer, select “Create Emg Protocol” .

BTS Bioengineering 37
 acquisition protocol

The window for the creation or modification of protocols will open.

If the receiver is connected to the PC and correctly set, in the first column of
the protocol table there will be reported the labels of the probes connected
to the receiver, and the active protocol will be displayed.

If the active protocol is not consistent with the set of probes

connected to the receiver the following warning message will be
displayed on the bottom part of the windows:

38 BTS Bioengineering
acquisition protocol

To proceed with the acquisitions it is necessary to have the probes

set and the selected protocol compatible.

To reach this condition it is possible:

- to select a line of the protocol and modify any fields to make
it consistent with the probes set,
- to select an other protocol compatible with the probes set
among the ones saved in the database and displayed in the
“Protocol folder” area of this windows, and set it as “Active
protocol” clicking on “Set Active”,
- coming back to the “Set Emg Device” windows and modify
the probes set.

To create a new protocol follow this procedure:

- click on “New”. The fields to be filled for the protocol creation will
be enabled.
- select the anatomical map containing the muscle you want to add to
the protocol and click on the little yellow square that identified it;
immediately the first free row available in the protocol table will be
filled with the info related to the selected muscle.

BTS Bioengineering 39
 acquisition protocol

- repeat this operation for all the muscles to be acquired.

- if you want to acquire Footswitches, select the “District” anatomical
map and proceed click on the right and then on the left foot by
selecting the corresponding square in the anatomical map:

- If you want to acquire Electrogoniometers, check the first free line in

the protocol table, click on the “Type” field and select EGN among
the voices available in the drop box menu.
In the same way, click on the “Description” field and select among the
drop box menu voices the angles you want to acquire with the EGN,
then on the “Side” field to select the body side to which the data refers.
- indicate a name for the protocol specifying it on the “Name” box.
-it is possible to insert also a short description of the protocol using the
appropriate box “Description”.

When every signal of the protocol has been inserted, proceed saving the

40 BTS Bioengineering
acquisition protocol

protocol, clicking on “Save”.

If the protocol is compatible with the probes combination allowed by the

system the protocol could be saved.

If the Probes setup is compatible with the protocol the following windows
will be displayed:

Clicking on “Yes” it will be set as “Active protocol” and will be used in the
next acquisition session.

Instead if the Probes setup is not compatible with the protocol the message
displayed will be:

To proceed with the acquisition it is necessary make the probes set

and “Active protocol” consistent.

In both cases clicking on “NO” the protocol will be saved in the “Protocol
Folder” and will be available in the future, but the “Active protocol” won’t
be modified.

BTS Bioengineering 41
 appendix A
technical specifications

Wireless Probes
Geometry: variable
Electrodes: standard with clip connection
Separation: min: 16mm - max: 66mm
Autonomy: 8h of use
some days stand-by
some months deep sleep
Battery: rechargeable, lithium ion
Dimensions: 14x41,5x24,8mm mother electrode
diameter 16x12mm satellite electrode
Weight: 13g battery included
Frequency used: ISM band
2.4GHz (standard IEEE802.15.4)
Input impedance: 100 MOhm
CMMR: >110 dB @ 50-60Hz
Resolution: 16bit
Acquisition frequency: 1KHz
Sensitivity: 1μV
Accuratezza di misura*: ± 2%

Receiving Unit
Connection: USB
Dimensions: 82x44x22,5mm
Weight: 80 gr

BTS Bioengineering 43
 appendix

Frequency used: ISM band

2.4GHz (standard IEEE802.15.4)

* The system is calibrated at the factory. No further calibration is required

BTS internal coding

Name of device, components, parts and/or Identifier for
accessories as per product label device (bar code,
catalogue, model or
part number)
FREEEMG 1000
USB receiving unit
FREEEMG 1000
EMG wireless probes

FSW/EGN wireless probe

Foot switches: Insole individual foot switches for the
automatic identification of the gait events.
FRESPU12
Electrogoniometers: Sensors for the measurement of
joint angles progress over the time.

EMG-Analyzer: software application for EMG signal

analysis SMAN0901

Charger
FRESPU06

44 BTS Bioengineering
 appendix B
environmental specifications

Min Max Note

Operating Temperature -20° +45°
Relative,
Operating Humidity 50% 80%
non-condensing
Storage and Transport
0° +40°
Temperature
Storage and Transport Relative,
50% 80%
Humidity non-condensing
Altitude 0m 2000m

Degrees of protection provided by the dangerous enclosures of water and

dust (IEC 60529): IPX0.

BTS Bioengineering 45
appendix C
power supply and switch off

The receiving unit is powered by the USB port.

To switch off the system the following operation must be done:

- Exit from the application software
- Unplug the receiving unit from the USB port.
- Put the probes in “Deep Sleep Mode” placing them on the “Charger”.

46 BTS Bioengineering
 appendix D
battery

BTS FREEEMG 1000 probes are internally powered.

The Probe battery replacement can be done only by BTS qualified

personnel.
The probes are sealed to avoid the access to the internal circuit
components.

Batteries are equipped with battery protection circuit to:

-over-voltage, threshold 4.3V
-under-voltage, threshold 2.8V
- short-circuits

The specific characteristic of the Wireless probes equipped with the battery
are:
Quantity: 1 per each EMG probe
Technology: lithium polymer (Li-Poly)
Removable: NO, BTS technical service is required

BTS Bioengineering 47
appendix E
declaration of conformity

DECLARATION OF CONFORMITY

BTS SpA
Via della Croce Rossa 11, 35129 Padova (PD) – Italy
Tel. +39 049 981 5500 Fax +39 049 792 9260

declare under our sole responsibility that the product(s):

name / description: Electromyographic system / device for recording myoelectrical activity.

model: FreeEMG 1000 / FreeEMG 100 RT
S/N: SN

satisfies the essential requirements of the Medical Devices Directive 93/42/EC (and its amendments inluding
2007/47/CE), and therefore carries the CE marking of the European Union. The conformity assessment procedure is
according to the article 11 of the directive (Annex II.3 full quality assurance) and the article 12 it is not applicable.

In accordance with Annex IX of the 93/42/EC directive it is classified as follow:

CLASS “IIa” (rule 10)

In accordance with IEC 60601-1 is also classified as follow:

Class: internally powered device Applied part type: BF

The product conforms to the following standards:

EN ISO 14971 Medical Devices - Application of risk management to medical devices.
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for basic safety and
essential performance.
IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: electromagnetic compatibility -
Requirements and tests.
IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and
essential performance - collateral Standard: Usability
EN 62304 Medical device software - Software life-cycle processes
ETSI EN 301 489-3 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Electromagnetic
Compatibility (EMC) – standard for radio equipment and services – Part 3: Specific
conditions for Short-Range Devices (SRD) operating on frequencies between 9 KHz and
40 GHz.
ETSI EN 301 440-2 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Short Range Devices
(SRD) – Radio equipment to be used in the 1 GHz to 40 GHz frequency range – Part 2:
Harmonized EN covering essential requirements of Article 3(2) of the R&TTE Directive.

This compliance is valid ONLY for the equipment identified when used in a manner consistent
with the intent of the referenced documents and according to the product’s usage manual.

Notified Body : TÜV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 München – Germa-
ny, Identification N. 0123.
EC certificate N. G1 12 10 65301 003 valid until January, 16 2018.

Padova, Date
Bruno Ros
CEO
BTS S.p.A.

48 BTS Bioengineering
 appendix F
regulatory notice

FDA Medical Device Reporting System—Reportable Events

Notice to Agents: for inclusion in all BTS systems supplied to the
United States of America, the master Medical Device Reporting
(MDR) file is located at BTS S.p.A. Should an adverse event occur,
the following form is to be completed and forwarded within one
working day to BTS S.p.A.

Department of Health & Human Services,

US Food and Drug Administration
Medical Device Reporting System—Reportable Events
Code of Federal Regulations
Title 21, Volume 8
Revised as of April 1, 2006
Cite: 21CFG803.32

Under 803.1(a) device user facilities and manufacturers must report

deaths and serious injuries to which a device has or may have caused or
contributed. Should such an event occur, please complete the following
details and forward the document in accordance with the applicable
regulations and time limits to one of the following addresses:

BTS S.p.A.
via della Croce Rossa 11
35129 Padova PD - Italy
tel +39 049 981 5500
fax +39 049 792 9260

BTS Bioengineering 49
 appendix

Adverse Event Report (21 CFR 803.32)

Use blank pages if required.

Section A. Patient Information

Patient confidentiality to be maintained unless authorized

otherwise in writing by User Facility.

Patient name or other identifier

Age at the time of the event (Years, Months),
or Date of birth (MM/DD/YYYY)
Gender Female Male
Weight lb kg

Section B. Adverse Event or Product Problem

Identification of adverse event or product problem

(check all that apply) Adverse Event
Product Use Error
Product Problem (e.g. defects/malfunctions)
Problem with Different Manufacturer of Same System

50 BTS Bioengineering
appendix

Outcomes attributed to the adverse event

(check all that apply) Death:
(MM/DD/YYYY)

Life-threatening injury or illness

Hospitalization—initial or prolonged
Required intervention to prevent permanent
impairment/ damage (Devices)
Disability or permanent damage:
Congenital Anomaly/Birth Defect
Other Serious (Important Medical Events)
Date of Event
(MM/DD/YYYY)

Date of this report

(MM/DD/YYYY)

Describe event, problem or product use error

(include a discussion of how the device was involved, nature of the
problem, patient follow-up or required treatment, and any environmental
conditions that may have influenced the event)

BTS Bioengineering 51
 appendix

Relevant tests/laboratory data, including dates

Other relevant history, including preexisting medical conditions

(e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney
problems, etc.)

Section C. Device Information

Brand Name
Type of Device
Manufacturer name
and address

Model # Lot #

Catalog # Expiration Date

(MM/DD/YYYY)

Serial # Other #

52 BTS Bioengineering
appendix

Operator of the device health professional

(delete not applicable)
patient
lay user
other:
(specify)

Date of system installation

(MM/DD/YYYY)

Device available for yes

evaluation?
no
(Do not send to FDA)
Returned to BTS S.p.A.
or its agents on:
(MM/DD/YYYY)

Concomitant medical products and therapy dates

(do not report products that were used to treat the event)

BTS Bioengineering 53
 appendix

Section D. Initial Reporter Information

For the reporter who initially provided information to you, or to the

manufacturer or distributor:

Name

Address

Telephone Number
E-mail Address

Health Professional? Yes

No
Occupation (include
speciality if appropriate)

Initial reporter also sent a Yes

copy of report to FDA?
No

54 BTS Bioengineering
appendix

Section E. User Facility Information

Health Professional? User Facility
Importer
User Facility Number
User Facility Name
User Facility Address
Contact Person
Phone Number
Date User Facility became
aware of event (MM/DD/YYYY)

Type of Report Initial

Follow-up #

Date of this Report

(MM/DD/YYYY)

Approximate age of system

Event problem Codes (refer to “MED-
WATCH Medical Device Reporting
Code Instructions”)
Report sent to FDA? Yes
(MM/DD/YYYY)

No
Report sent to Yes
manufacturer? (MM/DD/YYYY)

No

BTS Bioengineering 55
 appendix

Location where event Hospital

occurred
Home
Nursing Home
Outpatient Treatment Facility
Outpatient Diagnostic Facility
Ambulatory Surgical Facility
other:
(specify)

Manufacturer Name/Address

56 BTS Bioengineering
BTS Bioengineering Corp. BTS S.p.A.
147 Prince Street - Suite 11 viale Forlanini 40
11201 Brooklyn NY 20024 Garbagnate M.se MI
USA Italy
info: +1 347 204 7027 tel +39 02 366 490 00
helpdesk: +1 646 575 0426 fax +39 02 366 490 24

www.btsbioengineering.com
[email protected]