BTS Freeemg 1000 User manual
Patient preparation
78
When the footswitches need to be used, the sensors can be fixed to the contact areas using medical
adhesive tape (Figure 11.5).
Figure 11.5
Be careful to attach the tape on the striped side of the switch and not on the black side. If
the tape is applied on the black side its removal could cause the detachment of the
membrane making the switch unusable (Figure 11.6).
Figure 11.6
Patient preparation
79
When fixing the footswitches (FSW wireless probe + connecting cables + sensors) please be careful
of the following:
•The probes and cables must not hinder or interfere in any way with the patient’s
movements;
•During the entire duration of the movement pulling tension in the cables should be avoided.
To fix the electrogoniometers the use of double-sided adhesive tape is suggested.
Over compression or buckling of the sensor may damage it. We recommend positioning the
unstretched electrogoniometer with the joint fully extended. In this way joint bending will
cause the stretch of the sensor, not its compression.
Remember to turn on only the probes needed for the acquisition.
At the end of the exam, unfasten the EMG probes, turn them off and place them on the charger.
Remove the electrodes from skin sites by carefully peeling them off. Clean up any leftover gel,
adhesive or sweat that may be left behind.
Troubleshooting
80
12 Troubleshooting
Symptom: Problems with software application resolution
Possible reasons:
Size of desktop items is too large for software
graphical objects to be displayed correctly
Remedial action:
Change the size of text and other items on the
screen of your workstation (see the Graphical
resolution section of the Charger chapter).
Symptom: Problems with the application recognizing the receiving unit
Possible reasons:
Receiving unit not properly connected to the
workstation
Incorrect configuration
Remedial action:
Close the application and disconnect the
receiver. Wait 10 seconds then reconnect the
receiver to the USB port of the workstation.
Use the USB extension cable if the workstation
morphology does not allow a proper
connection. Restart the application.
Verify that the EMG Embedded device type is
selected in the configuration panel of the
application (see the System configuration
section in the System use chapter).
Symptom: Problems with EMG probe activation (the probe cannot be turned on)
Possible reasons:
Probe battery is low or fully discharged
Probe is fastened to the charger and the
charger power is on (probe is charging)
Remedial action:
Charge the probe (see the Charger chapter).
Unplug the probe or turn off the charger. Try
turning on the probe again (see the How to
turn on and off the FSW and EGN probes sub-
section in the EMG wireless probes chapter).
Troubleshooting
81
Symptom: Problems with probe connection or data transmission
Possible reasons:
Probe battery is low or fully discharged
Probe is turned off
Probe in error state (anomalous LED blinking)
Incorrect configuration of probe parameters
Interference on radio channel
During a real-time acquisition the probe has
been moved too far away from the receiver
Active protocol is not compatible with the
connected probe set
Remedial action:
Charge the probe (see the Charger chapter).
Turn on the probe (see the How to turn on and
off the FSW and EGN probes sub-section in the
EMG wireless probes chapter).
Reset the probe by turning it off and then
immediately on (see the How to turn on and
off the EMG probes in the EMG wireless
probes chapter or the Footswitch and
electrogoniometer kits chapter)
Verify probe serial number, type and label
code in the Sensor form of the configuration
panel (see the System configuration section in
the System use chapter).
Change the RF channel (see Appendix D –RF
Channel).
Use the acquisition with memory storage to
prevent signal loss. Uncheck the EMG Real
Time checkbox in the acquisition window (see
Patient record and trial acquisition).
Change active protocol or connect the
number of probes required by the active
protocol (see the Acquisition protocol
definition section in the System use chapter).
For more information on the connection problems see the Troubleshooting –probe(s) not
connected subsection of the System use chapter.
Symptom: Problems with EGN calibration –Red state icon
Possible reasons:
Probe battery is low or fully discharged
Remedial action:
Charge the probe (see the Charger chapter).
Troubleshooting
82
Probe is turned off
Probe in error state (anomalous LED blinking)
Incorrect configuration of probe parameters
Interference on radio channel
The probe has been moved too far away from
the receiver
Turn on the probe (see the How to turn on and
off the FSW and EGN probes sub-section in the
Footswitch and electrogoniometer kits
chapter).
Reset the probe by turning it off and then
immediately on (see the How to turn on and off
the FSW and EGN probes in the Footswitch and
electrogoniometer kits chapter)
Verify probe serial number, type and label
code in the Sensor form of the configuration
panel (see the System configuration section in
the System use chapter).
Change the RF channel (see Appendix D –RF
Channel).
Keep the probe within the range of the USB
receiver.
Warnings
83
13 Warnings
Safety information: Please read and follow these instructions carefully. The instrument's
safety cannot be guaranteed if they are not followed.
BTS FREEEMG 1000 is a medical device (EU Directive 93/42/EEC and its amendments, including
Directive 2007/47/EEC). Its use must be supervised at all times 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 laws, who
possess specific knowledge and competence on the anatomy and physiology of the muscular
system.
Since it has a high level of sensitivity (measured voltage levels of between 1 μV and 6 mV), the
instrument must be used in a typical commercial or hospital environment.
All pertinent state, regional, and local regulations for accident prevention, occupational safety, and
environmental protection must be observed when installing and using this product.
Do not wet or wash any electronic device component with water or other liquids. To clean the
system components use a soft cloth damped with neutral soap. System components are NOT
protected from liquid infiltration.
No modification of the equipment is allowed:
•Maintenance and repair of the BTS FREEEMG 1000 system (all components included) may
be carried out only by BTS S.p.A. authorized technicians.
•Modifying the product, substituting or changing any hardware or software part included in
the system could drastically affect performance and may void existing warranties.
•BTS S.p.A. cannot be held responsible for system safety in case of any alteration of the
product.
Under no circumstances the integrity of the system and of all its components must be compromised.
In case of malfunctioning or accidental damage of any system component, always address the
technical service for assistance.
See Appendix E –Technical Service and Repair for detailed information on how to contact
BTS Customer Service.
Use only the power supply unit FW7363M/09 (FRIWO) or an equivalent one provided by BTS S.p.A.
for supplying the charger unit. If a different power supply unit not expressly approved by BTS S.p.A.
is used, the compliance to IEC 60601-1 is not ensured. Moreover, the use of other power supply
units can damage the system.
Warnings
84
For a correct use and maintenance of the rechargeable batteries and the charger strictly follow the
instructions included in this manual.
For detailed information about batteries see Appendix C –Battery. For detailed information
about the correct use of the system see the System use chapter.
In case of need disconnecting the mains plug from the electrical outlet will stop the flow of electricity
through the charger.
Use only the original accessories and cables specified in the documentation and no third-party
devices or components that have not been expressly approved by BTS S.p.A.
Old versions of the wireless probes are not compatible with the newest version.
BTS S.p.A. cannot be held responsible for system malfunctioning arising from the use of a Personal
Computer not complying with the system requirements specified in the Minimum system
requirements for the user workstation section of the Installation chapter.
The workstation used with the BTS FREEEMG 1000 should be dedicated solely to the use of BTS
hardware and software. Making changes to the Operating System or installing third-party software
may affect the system performance. For any question of concern about the product and the
installation of third-party software please contact the technical support.
BTS FREEEMG 1000 is able to work CONTINUOUSLY. The duration of the acquisitions are only limited
by battery duration and data storage availability.
The information on this manual is believed to be complete and reliable; however, the information
may contain inaccuracies, omissions or typographical errors. BTS S.p.A. expressly disclaims any
obligation or duty to update or correct information contained in this manual.
The specifications and information regarding the product in this manual are subject to change at
any time without notice and without incurring any obligations.
Appendix A –Technical specifications
85
14 Appendix A –Technical specifications
14.1 EMG wireless probes
Dimensions and weight
•Weight: ≈13 g (battery included)
≈0.46 oz (battery included)
•Mother electrode: 41.5 mm L x 24.8 mm W x 14 mm H
1.63 in L x 0.98 in W x 0.55 in H
•Satellite electrode: 16 mm D (diameter) x 12 mm H
0.63 in D (diameter) x 0.47 in H
•Variable geometry: electrodes separation from 16 mm to 66 mm
(from 0.63 in to 2.6 in)
Electrodes
•Standard with snap connectors for the connection with pre-gelled disposable snap
electrodes
Performance characteristics
•Transmission frequency: 2.4GHz ISM band (standard IEEE 802.15.4)
•Input impedance: 100MΩ
•Resolution: 16bit
•Common-mode rejection ratio: >110db @ 50-60Hz
•Sample rate: 1KHz
•Sensitivity: 1μV
•Accuracy*: ±2%
Battery
•Type: rechargeable lithium-ion polymer battery
•Battery life: over 6 hours of continuous acquisition
•Recharge time: 2 hours
*The probes are calibrated at the factory. No further calibration is required.
Appendix A –Technical specifications
86
14.2 FSW and EGN wireless probes
Dimensions and weight
•Weight: ≈11 g (battery included)
≈0.39 oz (battery included)
•Dimensions: 47.3 mm L x 37.3 mm W x 9.5 mm H
1.86 in L x 1.47 in W x 0.37 in H
Performance characteristics
•Transmission frequency: 2.4GHz ISM band (standard IEEE 802.15.4)
•Input impedance: 1GΩ
•Resolution: 16bit
•Common-mode rejection ratio: >86db
•Sample rate: 100Hz
Battery
•Type: rechargeable lithium-ion polymer battery
•Battery life: over 6 hours of continuous acquisition
•Recharge time: 2 hours
14.3 Receiving Unit
Dimensions and weight
•Weight : ≈80 g
≈2.82 oz
•Dimensions: 80 mm L x 45.5 mm W x 14.4 mm H
3.14 in L x 1.79 in W x 0.57 in H
Performance characteristics
•Transmission frequency: 2.4GHz ISM band (standard IEEE 802.15.4)
•Connection: USB 2.0
Appendix A –Technical specifications
87
14.4 Expected Useful Lifetime
The lifetime of the system is 8 years: during this period of time each system component can be
substituted or repaired while preserving system functionalities. The most critical component is the
internal battery which lifetime depends on the number of charge-discharge cycles; substitution
might be necessary after a few years (on average from 3 to 4 years).
14.5 IP (Ingress Protection) Rating
Degree of protection provided by the enclosures against liquids and solid foreign objects (IEC
60529): IPX0.
Appendix B –Conditions for operation, storage and
transport
88
15 Appendix B –Conditions for operation, storage and transport
Recommended storage temperature during transportation is at 23°C (73.4°F).
For extended storage or when travelling:
•Unplug the receiving unit from the USB port
•Turn off the EMG probes
•Place all probes into the charging station
•Position all components inside the BTS FREEEMG 1000 travelling case according to their
prepared cavities
15.1 Cleaning
System components are not constructed to withstand repeated application of any disinfectant
solution and are NOT protected from liquid infiltration.
To clean the system components use a soft cloth slightly damped with neutral soap.
Do not wet or wash any electronic device component with water or other liquids.
Min
Max
Note
Operating Temperature
0°C
32°F
+40°C
104°F
Operating Humidity
20%
80%
Relative,
non-condensing
Operating Pressure
70kPa
106kPa
Storage and Transport
Temperature
-20°C
-4°F
+45°C
+113°F
Storage and Transport
Humidity
50%
80%
Relative,
non-condensing
Altitude
0m
0ft
2000m
6562ft
Appendix C –Battery
89
16 Appendix C –Battery
The wireless probes included in the BTS FREEEMG 1000 system are internally powered.
Each probe contains a single lithium-ion polymer battery. Do not damage, crush, burn, freeze or
otherwise mishandle the probes. Recharge only with the approved power supply and charger.
The probes enclosures are factory-sealed to prevent physical access to the internal circuitry. For
battery replacement and disposal please contact the technical support.
On average, 75 % of original battery capacity is maintained after 300 discharged/recharge cycles or
after 3 years, if recharge cycles are less than 300. These values represent typical expectations under
normal conditions. Actual performance will vary depending on usage conditions.
To maximize battery-life we suggest minimizing the number of charge/discharge cycles. For this
reason we recommend not to charge the probes more than once a day.
Batteries are equipped with:
•over-voltage protection circuitry, threshold 4.3V
•under-voltage protection circuitry, threshold 2.8V
•short-circuits protection.
Appendix D –RF Channel
90
17 Appendix D –RF Channel
The BTS FREEEMG 1000 operates in the 2.4 GHz ISM band which is shared by wireless networks and
personal communication devices.
The system can be set to operate at one of 16 different radio frequencies within the 2.4 GHz band.
If a lot of WiFi traffic is present on the selected RF Channel, connection problems may occur.
Changing the RF Channel to another frequency may solve this issue. If the RF Channel needs to be
changed manually, insert a new frequency (range 11-26) in the corresponding field of the EMG
devices configuration panel and check the Manual RF channels checkbox (Figure 10.17). Update the
configuration and then take a new measurement to determine if the problem is solved. If a
frequency out of range is inserted, the system will automatically set the RF channel to the default
value: 11.
Figure 17.1
Once the combination of WiFi channels being used in the proximity of the BTS FREEMG 1000 is
determined, use the chart below to select a RF channel that does not share, as much as possible,
the same radio frequencies of the external WiFi devices.
The chart allows the identification of which RF channel of the receiving unit interfere with which
WiFi channels. The light-blue colour identifies channels that share the same radio frequencies.
Appendix D –RF Channel
91
WIFI CHANNELS
RF CHANNELS
1
2
3
4
5
6
7
8
9
10
11
12
13
14
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
If the identification of the occupied WiFi channels, in the environment surrounding the BTS
FREEEMG 1000, is not possible, try using the following RF Channel: 15. If the problem was not solved,
try using the RF Channel 20. At last, if the issue was still not solved, try using the RF Channel 25
Appendix E –Technical Service and Repair
92
18 Appendix E –Technical Service and Repair
In case of malfunctioning or accidental damage of any system component, always address the
technical service for assistance: [email protected] . In the email please specify the
following:
•your organization name
•product name (BTS FREEEMG 1000)
•serial number of the receiving unit and of any malfunctioning probe. To locate the probe’s
serial number, see the EMG probes components section/subsection of the EMG wireless
probes or Footswitch and electrogoniometer kits chapters.
•operating system and version (32-bit or 64-bit)
•software (e.g. EMG Analyzer, SMART Analyzer, SMART Clinic…) and software version (click
on Help > About in the main application window)
•detailed description of the problem being experienced. Please include:
oa description of the operations that had been carried out just before the problem
was experienced
oa copy of the text of the error message(s)
We suggest including any file that might help us understanding the problem, e.g. screenshots,
acquisition files, etc...
This information will help us to better respond to your request.
18.1 Returning Equipment
Be sure to obtain an RMA Number (Return Material Authorization) before returning any equipment.
To obtain a RMA number, please contact the helpdesk service. If the return of the equipment is
needed, a BTS S.p.A. authorized technician will provide you an RMA Number.
To return the system or any of its components use the original packaging or an equivalent one
affording an equal degree of protection.
Improper packaging may void existing warranties.
Appendix E –Technical Service and Repair
93
18.2 Remote assistance
After contacting the Technical Service, in case a remote session has been deemed necessary by a
customer care technician, the use of the Teamviewer software will be required. This software can
be found inside the USB key provided with the system, under the Teamviewer –Remote support
folder (Figure 18.1).
It is recommended to copy this folder on the workstation’s desktop to have it available at all
times.
Figure 18.1
On the date and at the time of the scheduled remote session, the software can be opened by double
clicking on TeamViewer8_QS_en.exe. The ID and Password provided by the software must be sent
to the service technician to allow for the remote connection.
If an internet connection is available and properly working, the dot at the bottom of the window
will be green, and the message Ready to connect will be displayed (Figure 18.2).
Appendix E –Technical Service and Repair
94
Figure 18.2
If the dot is red or yellow, please check the proper functioning of the internet connection.
Appendix F –Disposal (WEEE)
95
19 Appendix F –Disposal (WEEE)
Observe the legal prescriptions when disposing of the equipment.
This symbol indicates that the device should not be disposed of as household waste.
For proper disposal or recycling of the device please take it to applicable collection
points, in accordance with applicable national legislation and the Directive
2002/96/EC (WEEE).
The purpose of separating WEEE and batteries from other waste is to minimize the
potential environmental impacts and human health risk of any hazardous
substances that may be present.
For more detailed information about the device disposal please contact the manufacturer.
The BTS FREEEMG1000 belongs to Category 8 (medical equipment) and is classified as Business-to-
Business equipment.
For detailed information about batteries see Appendix C –Battery. For correct equipment
operation see the Warnings chapter.
Appendix G –Symbols on the equipment
96
20 Appendix G –Symbols on the equipment
Manufacturer.
This device complies with the regulations established by the U.S.
Federal Communication Commission (FCC).
In accordance with Standard ISO 60601-1, the device has an internal
power supply and type BF applied parts.
Attention! Read the instructions carefully before using the device.
Class II medical device (in accordance with EN 60601-1).
CE Mark and Notified Body number. The CE mark indicates that the
device satisfies the essential requirements of the Medical Devices
Directive 93/42/EEC. Notified Body: TÜV SÜD Product Service
GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München (Germany),
Identification N. 0123.
CE Mark and Notified Body number. The CE mark indicates that the
product conforms to the R&TTE Directive 99/05/EEC and obtained
the certificate of Expert Opinion from the IMQ Notified Body: IMQ
S.p.A. a single member company, Via Quintiliano, 443, 20138 Milan
(Italy), Identification N. 0051.
Separate disposal of electrical and electronic equipment, in
accordance with Directive 2002/96/EEC (WEEE). The equipment
belongs to Category 8 (medical equipment). In force in the nations
of the European Union, Norway and Switzerland.
Caution: the U.S. Federal law restricts this device to sale by or on
the order of a physician or other licensed healthcare practitioner.
REF
Catalogue number.
SN
Serial number.
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