COMETA WAVE PLUS User Manual

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“WAVE PLUS”

MULTICHANNEL

ELECTROMYOGRAPH

USER MANUAL

Redaction:

SALES – M. DELLACORNA
GM – A. DELLACORNA

Check:

GM – A. DELLACORNA

Approval:

GM – A. DELLACORNA

Data: 24/02/2012

Revision: 01

Code: WPMENG

Revision:

Revision:

Approval Date:

Changes Description:

01

24/02/2012

Revision post IMQ review

The system is classified according to 93/42/CEE regulation

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 such that may cause undesired operations.

Any change or modification not expressly approved by Cometa Srl for compliance could void

the user’s authority to operate the equipment.

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Table of Contents

1. INTRODUCTION ...................................................................................................................................................................... 3

2. DESTINATION AND CLASSIFICATION ............................................................................................................................. 3

2.1 HOW TO USE IT ........................................................................................................................................................................................ 5

3. WAVE PLUS SYSTEM COMPONENTS ............................................................................................................................... 6

3.1 FUNDAMENTAL, OPTIONAL AND ACCESSORY COMPONENTS ............................................................................................................ 7

3.2 WIRELESS ELECTRODES ......................................................................................................................................................................... 7

3.3 BASE UNIT ................................................................................................................................................................................................ 9

3.4 DOCKING MODULE ............................................................................................................................................................................... 10

4. WAVE PLUS SYSTEM USE .................................................................................................................................................. 11

4.1 ANALOG MODE ..................................................................................................................................................................................... 11

4.1.1 Supported external devices .................................................................................................................................................... 12

4.1.2 Layout of cable connections .................................................................................................................................................. 13

4.2 DIGITAL MODE ...................................................................................................................................................................................... 14

4.2.1 External trigger .......................................................................................................................................................................... 15

4.2.1.1 Trig in ............................................................................................................................................................................................................ 16

4.2.1.2 Trig out ......................................................................................................................................................................................................... 16

4.2.1.3 Strobe IO ...................................................................................................................................................................................................... 16

4.2.1.4 How to use the Trigger port ............................................................................................................................................................... 17

4.2.2 Supported external devices .................................................................................................................................................... 18

4.3 LED SIGNALLING DURING OPERATION ............................................................................................................................................. 19

4.3.1 Base unit LEDs: ........................................................................................................................................................................... 19

4.3.2 Electrode unit LED: ................................................................................................................................................................... 19

4.4 PRE-GELLED ELECTRODES.................................................................................................................................................................. 19

4.5 ELECTRODES BATTERY RECHARGE ................................................................................................................................................... 20

4.5.1 LED indicator of the charging module .............................................................................................................................. 20

4.5.2 LED indicator of the electrodes ............................................................................................................................................ 21

4.6 WARNINGS ............................................................................................................................................................................................ 21

4.7 PIEZORESISTIVE SENSORS .................................................................................................................................................................. 23

5. SYSTEM MAINTENANCE .................................................................................................................................................... 25

5.1 REPAIRABLE PARTS ............................................................................................................................................................................. 25

5.2 REPLACEMENT OF ELECTRODE BATTERY......................................................................................................................................... 26

5.3 ELECTRODE BATTERY CHARACTERISTICS ........................................................................................................................................ 28

5.4 WARNINGS ABOUT ELECTRODES BATTERY ...................................................................................................................................... 29

5.4.1 General warnings ....................................................................................................................................................................... 29

5.4.2 Warnings for battery disposal .............................................................................................................................................. 30

5.4.3 Warnings for device disposal ................................................................................................................................................ 30

5.5 REPLACEMENT OF WORN PARTS ....................................................................................................................................................... 30

5.6 WAVE PLUS CLEANING ....................................................................................................................................................................... 30

5.7 REFERENCES ......................................................................................................................................................................................... 31

6. LABELS .................................................................................................................................................................................... 32

6.1 BASE UNIT: ........................................................................................................................................................................................... 32

6.2 BRIEF CASE WITH CHARGER: .............................................................................................................................................................. 32

6.3 INDUCTIVE CHARGER (INSIDE THE BRIEF CASE, UP TO TWO UNITS): .......................................................................................... 33

6.4 ELETTRODI: .......................................................................................................................................................................................... 33

7. TECHNICAL SPECIFICATIONS (WAVE PLUS 16 CH) ................................................................................................. 35

7.1 SUITABILITY.......................................................................................................................................................................................... 37

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1. INTRODUCTION

Wave Plus system is an innovative multi-channel wireless surface electromyographic system with
accelerometers.

The leading specifications of this new system are:

Wireless and low-power electrodes for a quick patient set-up and for movements performed in total

freedom;

Acquisition of SEMG signal simultaneously with the accelerometer signal
Digital transmission via RF;
Receiver device equipped with analog and digital (USB port) data output for all channels;
Developed with high integration “SMD” technology;
Compatible with ISM standard – low power devices (ETSI, FCC, JAPAN);
Designed to be integrated with lab equipment for multipurpose acquisition systems.

2. DESTINATION AND CLASSIFICATION

Wave Plus is a system for the data collection of biologic signals; the main system feature is the absence
of cables between the transmitters on the patient and the data receiver/recording unit.

This allows the acquisition of EMG and accelerometer signal while patient is free to move.
This feature is very useful for clinical and scientific applications, for example in pathologic gait analysis

or in rehabilitation.
Low invasivity and high safety allow to use Wave Plus system for patients who tolerate the adhesive

electrodes and conductive gel for SEMG detection through medical electrodes.
Wave Plus system application areas are:

Neurology;
Physiatry and rehabilitation;
Orthopedy;
Ergonomics;
Sport medicine;
Veterinary.

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Wave Plus system is classified according to CEI 60601-1:1998:

- The applied part is a BF type according to CEI EN 60601-2-40 regulation (icon):

- Second class device working with an external power supply providing power to internal peripheral

units; lithium rechargeable battery (icon):

- IPX0 protection degree of shells (NOT water proof);

- Functioning type: continuous.

Other graphic symbols on equipment:

-Ambient operating humidity range(graphic symbol):

-The device and its components must be disposed of according to regulations in the country of
use(graphic symbol):

-Ambient temperature range of operation(graphic symbol):

-Consult the user manual for instructions on operating (graphic symbol):

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2.1 How to use it

To use Wave Plus, two pre-gelled disposable electrodes for each channel have to be applied to the
subject. The EMG acquisition module is applied on the surface electrodes using a snap connector.

If required by the exam, piezoelectric sensors are applied for the identification of plantar supports; the
foot-switch acquisition module is applied to the sensor by the appropriate cables.

To use the Wave Plus system only as an inertial acquisition system, that is by using only the
accelerometers included in the probes and not the EMG signal acquisition, it is sufficient to attach or
strip the probes in the designated place, without any need for pre-gelled electrodes.

Wave Plus system can be used by doctors, paramedics and technicians.

To use Wave Plus system, please, read carefully the instructions in the relative chapter.

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3. WAVE PLUS SYSTEM COMPONENTS

The following representation shows all Wave Plus components.

The standard configuration of the system is composed of:

 EMG / accelerometer wireless modules, whit snap connections to the electrodes;
 two wireless modules, to transmit gait cycle events (footswitches);
 a receiver unit;
 a docking box to recharge the wireless modules.

Wireless modules are equipped with an internal rechargeable battery. The modules communicate with
the PC through the base unit thanks to a bi-directional link working at 2400 MHz.

When not used, modules should be displaced in the dedicated areas of the docking box to receive energy
for battery recharge.

An automatic system for power saving optimise battery life during the phases in which the electrodes
are not used.

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3.1 Fundamental, optional and accessory components

3.2 Wireless electrodes

The Wave Plus system module is composed of two parts:

 The conditioning signal module, with active circuitry for signal radio-transmission;
 Power supply module and I/O interface including rechargeable battery, recharge coil, and the

connections to the detection points.

SYSTEM ELEMENTS

Classification

Base Unit

Fundamental

Friwo power supply FW7555M/09

Fundamental

Docking base

Fundamental

EMG Electrodes

Optional

USB Cable

Optional

Analogue Cable

Accessory

Foot-switch Electrodes

Accessory

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The power supply module is connected to the acquisition unit through a sliding mechanism; the unit
disassembly should be done only during maintenance (exhausted battery or electric wire deteriorated).
In these cases follow the instructions in the chapter “Replacement of electrode battery”.

Each EMG module (total of 16) is also equipped with a tri-axis accelerometer, able to capture the
minimum movement of the body in space. The disposition of the accelerometer sensors is the following:

The electrodes are realized with fully bio-compatible plastic produced by Bayer. Below teh factsheet of
the material used for the electrodes casings:

In order to apply the electrodes on the patient’s skin it is necessary to use bi-adhesive tape suitable to be in
contact with the skin and therefore certified to that use, such as the 3M 1522 Double Coated Medical Tape
produced and certified by 3M.

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3.3 Base unit

The base unit has a front panel with status LEDs.
The signals are:

LED off: the electrode is non active;
LED on: green light: the electrode is active.

The front panel has also a further green LED indicating the on/off status of the base unit.

On the rear panel:

on-off switch;
jack for the external power supply
female port SCSI 68 pin for analog outputs;
jack for the connection of the external trigger;
USB port to connect the host PC;
LED showing presence of supply;
LED for auxiliary functions (CHG) – not active

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The base unit has a RF transceiver at 2,4 GHz, a microprocessor for data synchronisation and separa­tion, D/A converter, a USB port to connect the host PC.

The base unit can be supplied with built–in antennas (as standard), or with external antennas. The appli­cation of the external antennas allows the extension of the useful working area of the system.

3.4 Docking module

When not in use, wireless electrodes should be in the docking module to recharge the batteries.

The recharge occurs by coils, attached to the electrodes support base and on the layer of the charger; the
energy transfer occurs via induction.

Coils on the docking are excited to resonance by adequate impulses in frequency and amplitude; when
the electrode is on the docking, there is an induced alternate current in the electrode coil that will be sent
to the battery for its recharging.

The docking module has a LED status indicator of the charger; during charging the LED is orange,
when charging is over, the LED turns to green, as described below.

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4. WAVE PLUS SYSTEM USE

Wave Plus system can be used in two different configurations:

Linked to an A/D converter for visualisation and analog storage of EMG and basography

data, adopting external devices;

Linked to a PC through the USB port for visualisation, system control and digital data stor-

age of EMG and basography (third party software not produced by Cometa srl).

The two configurations can be used simultaneously.

4.1 Analog mode

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To operate the system:

1) Connect J26 connector of Wave Plus by cable (analog output) to the analog A/D interface of

the external device;

2) If required, connect the trigger cable to the external device. Check trigger electric features

(voltage and timing) adopted by the system (see “Technical specifications” chapter);

3) Connect Wave Plus power supply and switch on the system.

The system can be powered only with Friwo FW7555M/09 power supply provided by the
producer; the use of other power supply units can cause electric shock and damage the
system.

If used in analog mode, the system does not require a Personal Computer; after switching on the base
unit, EMG and basographic signals are available in continuous on analog output connector J26.

4.1.1 Supported external devices

The Wave Plus system can be connected to analog devices commonly used in clinical and scientific en­vironments; these are the features required by systems:

At least 8 or 16 EMG data collection channels, configured for signals with Zout = 100 ohm and

an amplitude of ± 2,5 V;

At least two analog channels to acquire footswitches, configured for signals with Zout = 100

ohm and an amplitude of + 2,5 V;

If also accelerometer signals has to be transmitted to the analog device, another24 or 48 data

collection channels (3 for each tri-axis accelerometer) are needed;

It complies with IEC 60950.

The use of external devices non-complying with IEC 60950 can cause electric shock and
damage the system. The external devices connected to Wave Plus with an analog
interface, do not have any control over the system acquisition or settings. Any third party

system used with Wave Plus has to be placed out of the patient area, and must be
powered via an isolation transformer or power supply conform to the IEC 60601-1.

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4.1.2 Layout of cable connections

Pin out of the analog output connector.

X2

Z4
Z9

EMG_CH5

Y2
X3

X5

EMG_CH4

Z2

X9

EMG_CH3

1
2
3
4
5
6
7
8

9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68

J26

CONN SCSI 68-R

Y3

X4

EMG_CH2

Y5

Z3

EMG_CH1

Y4

X5

Y9

Z4

Y16

Y5

Z15

Z5

Z14

Y6

X15

Z6

X16

Z13

Y7

X6

X14

Z7

X13

Y8

Z16

Y6

Z8

X7

Y15

FSW_A

Y9

Z6

X1

Y14

Z9

X8

Z5

X7

Y10

Y13

Z10

X6

X9

Y7

Z1

Y11

GND_ANA

Z7

Z11

X10

EMG_CH16

X2

EMG_CH15

Y12

EMG_CH14

X8

Z12

X11

EMG_CH13

Y2

Y13

EMG_CH12

Y8

Z13

X12

EMG_CH11

X3

Y14

EMG_CH10

Z8

Z14

EMG_CH9

X13

FSW_B

Z2

Y15

X11

Z12

Z15

X14

Z3

Y3

Y16

Y12

Z10

Z16

X15

GND_ANA

X4

X1

X12

Y10

EMG_CH6

X16

Z11

Y4

EMG_CH8

X10

EMG_CH7

Z1

Y1

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4.2 Digital mode

To operate the system:

1. Connect Wave Plus USB cable to the PC USB port. The power is taken directly from the USB

port;

The use of Personal Computer non-complying with IEC 60950 can cause electric shock
and damage the system. The use of Personal Computer non-complying with IEC 60950
is allowed using a medical class insulation transformer to power the PC.

2. If required, connect the trigger cable to the external device, after checking trigger electric fea-

ture (voltage and timing) adopted by the system (read “Technical specifications” chapter);

3. Connect, if required, the Wave Plus power supply and switch on the system;

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Use only the supplied power supply FRIWO FW7555M/09 . The use of other units
could lead to electric shock or damage to the instrumentation.

4. open the control program and follow the third party software indication for data graphic render-

ing and digital data collection.

The operation of the system Wave Plus is now under the control of the Personal Computer. Refer to
the User Manual supplied by the manufacturer of third party software for the description of the oper­ational commands. The following table gives the references:

Software Code: NA
Release: NA
Manufactured by: NA

When operating in digital mode, the device is powered directly from the PC via the
USB interface; for correct operation, the connection must provide the rated current
provided by the USB II specification(500mA). In this case, the use of the external
power supply is optional, and the computer must be powered via an isolation trans-

former or power supply according to IEC60601-1.
You can also use a personal computer equipped with USB ports with reduced current
(100mA), in which case you must connect, in addition to the USB cable, the external
power supply.

4.2.1 External trigger

Wave Plus has a connector for external trigger of data capture. External trigger lines are
not insulated from the Wave Plus system ground.

The use of external devices not complying with IEC 60950 can cause electric shock and
damage the system.

Pin out of the trigger jack:

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TRIG_IN

STROBE I/O

GND

1

2

3
4

J22

TRIG_OUT

4.2.1.1 Trig in

Data capture can be synchronised with an external trigger signal. If required, connect the trigger cable to
the external device after checking that the trigger control complies with the electric features required by
the system (see “Technical Specifications”).

Trigger logic:

1) Data acquisition if the “trigger in” signal is at “1” logic level

2) No data acquisition if the “trigger in” signal is at “0” logic level

The default condition of the line is “1”.
Storing data on the hard disk of your computer is managed by the acquisition and processing SW; for

information about the data file format and processing, refer to the user manual of the SW.

4.2.1.2 Trig out

A “trigger out” channel shows the system status:

1) “Trig out” signal at “1” logic level when the system is acquiring

2) “Trig out” signal at “0” logic level when the system is not acquiring

4.2.1.3 Strobe IO

The line "Strobe IO" is used for synchronization of a second Wave Plus receiver for the expansion to
32channelsof the system. This line is used by the system and should only be connected to another Wave
Plus unit, according to information provided by Cometa.

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4.2.1.4 How to use the Trigger port

Usually, the Triggers (Input and Output) are used when the Wave Plus system is interfaced with third­party devices by digital port (USB). Here below, you can see the typical configuration in order to obtain
the synchronisation between the Wave Plus EMG system and a third-party device by using the Trig
In/Out port.

For further details on how to use the Trigger option, please refer to the third party software manual
provided by the producer of the software used.

However, it is some way possible to synchronize the Wave Plus EMG system and a third-party device
also using the analog EMG signals. Here below, there is a simple scheme which describes how to
implement this type of synchronism.

We can consider two possible modes for synchronous recording. In the first case, we assume that the
third-party device is able to control the synchronous acquisition by using its own “internal

synchronisms” mechanism; in this case the synchronisms will be totally handled by software/firmware

of the third-party device self. In the second case, we assume the third-party acquisition device must

“read” a trigger signal or record a “start” event into the acquisition data streaming (e.g. the event

related to the TMS stimulation).
In this latter case, we suggest to record both, the signals coming from the Wave Plus analog output and

the trigger signal, using the same A/D converter. In that way, not only the Wave Plus data, but also the

Acquisition

system

(accelerometer, ba-

ropodometer, etc.)

PC with

dedicated

software

Wave Plus

PC with

dedicated

software

Trig In/Out

USB Data

Digital Da­ta

Third-party acquisition system

Wave Plus EMG

Acquisition

system

(accelerometer, ba-

ropodometer, etc.)

PC with

dedicated

software

Wave Plus

Wave Plus analogue
data

Digital da­ta

A

/

D

Trig
Out

Wave Plus Trig Out

Wave Plus digital

data

Third-party acquisition system

Wave Plus system

U
S

PC with

dedicated

software

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event of the beginning and the end of the data acquisition or, in general, a temporal reference event
(e.g. the timing of the TMS stimulation) can be directly saved into the same data streaming.

The scheme above shows the required connections to realise this type of synchronism in case:

1. The third-party device is working as master: red connection;

2. The Wave Plus system is working as master: blue connection1.

NOTE THAT if you want synchronize the Wave Plus system with third-party devices collecting the
EMG signals from the Wave Plus analogue port, you should also consider the 13 ms delay related to
the Wave Plus analogue output. In this case you should correct the recorded data in order to remove the
13 ms delay. NOTE THAT the 14 ms delay is constant and it can be easily removed by shifting the
temporal sequence in the following way:

NOTE THAT the delay does not produce a loss of acquired data at all.
Please, for further details contact Cometa.

4.2.2 Supported external devices

Wave Plus system can be connected to any PC with USB interface; these are the features required by
systems:

 Type 2 USB interface
 Windows 2000 or XP
 VGA graphic card with a resolution of at least 1024 x 768
 Minimum ram memory, 512 MB
 Minimum processor frequency, 800 MHz
 Minimum hard disk, 20 GB

1

In this case, it’s necessary to use also the dedicated software in order to produce the trigger signal.

Unrecorded sequence

Recorded sequence

Unrecorded sequence

Trigger Off

Trigger On

Trigger Off

Unrecorded sequence

Recorded sequence

Unrecorded sequence

14ms

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The Personal Computer linked with the Wave Plus system has to comply with IEC 60950
regulation and has to be placed outside the patient’s area. The use of Personal Computer
non-complying with IEC 60950 is allowed using a medical class insulation transformer to
power the PC. The software (produced and commercialized by third parties) has to com­ply with the CE93/42 regulations for medical devices.

4.3 LED signalling during operation

4.3.1 Base unit LEDs:

During Wave Plus functioning, LEDs are used to indicate the functioning status of the system.
On the base unit front panel there are eighteen bicolour LEDs:

- LED off: the correspondent electrode is in stand–by (non active);

- LED on, green light: the electrode is on;

- LED on, orange light: the electrode is on and the battery is low.

4.3.2 Electrode unit LED:

On the EMG unit there is one LED:

- LED off: the electrode is in stand–by condition (not active);

- LED on, green light: the electrode is on and recognised by the receiver unit;

- LED blinking green light: the electrode is on and the battery is low.

The LED of the transmitting module, when the electrode is placed on the charging cradle, also carries an
indicator function of the charging phases. In this case the color of the LED is orange. For more informa­tion, refer to the battery charger chapter.

4.4 Pre-gelled electrodes

The Wave Plus system can be used with single-use pre-gelled electrodes equipped with snaps. Pre­gelled electrodes are available in different dimensions, and may be purchased through local distributors
of consumable medical accessories.

To apply electrodes see the information provided by the manufacturer.

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Warning: the quality of the EMG signal acquired by the Wave Plus system is linked to the quality of
the contact between electrode and skin; to obtain best results:

1. Use pre-gelled electrodes certified for a medical use and complying with the 93/42/CEE

regulation;

2. Do not use pre-gelled electrodes beyond the expiration date or with dry conductive gel;

3. Do not re-use the same electrode;

4. Do not use the electrode after having already applied it;

5. For long data acquisition periods, check the electrodes adhesive;

6. Apply electrodes only on undamaged skin and verify that their removal does not cause any

damage.

4.5 Electrodes battery recharge

To recharge the electrode batteries, put the electrode in the appropriate slot in the recharging module;
then power on the recharging module and wait for the signal that indicates the end of the recharging pe­riod.

The jack socket for the power supply is accessible on the left side of the briefcase.

The charging module is equipped with an eight hours timer, after which the charge is automati­cally stopped. This allows the unlimited permanence of electrodes into their respective hous­ings, without the risk of overload the batteries.
To reset the timer and start a new charge cycle, you must disconnect the power jack and then
reconnect it.

4.5.1 LED indicator of the charging module

The operation of the charging module is indicated by a bicolor LED placed in the center of the unit;
alerts are:

1)Led Orange: the charger is on and the electrodes placed in the charging slots are subject to
charge;

2)LED green: the unit has completed the eight-hour charge cycle.

It is recommended to leave the case open during the recharge of the electrodes
units.

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If the batteries are deeply discharged, it may be necessary to perform two or more charge
cycles, to restore its original capacity.

The electrode, when not in use, has a very low power consumption and maintains the charge for a long
time, but to maximize the life of the battery, in case of non-use, we suggest to perform at least one
charge cycle every three months.

4.5.2 LED indicator of the electrodes

When the probes are charging, the green LED light provides an indication about the level of charge.
Particularly, three states are available:

1) LED orange flashing at one flash/sec.: probe on pre-charge (when battery is entirely un-

charged);

2) LED orange flashing at five flash/sec.: probe on normal charging phase;

3) LED orange off: full charge

The transmitter units can be charged by placing on the charger the only lower part of the electrode. The
feedback on the state of charge takes place through a second green LED placed within that module.
Charging is complete when the LED is off.

IMPORTANTNOTE. The unit placed in the docking box, during the charging process, do not trans­mit. This is valid only during the charging process (charging module active -Orange LED). At the end
of the charging cycle, the transmitting units resume its normal functionality.

4.6 Warnings

Extended non-use of the device

If the device has not been used for a long time, we suggest to:

Recharge the electrodes battery every six months, or,
Unlink/Disconnect the EMG acquisition module from the battery module

and keep the elements in a dry and clean environment.

How to use the device in an environment in which a wireless LAN is working

If the Wave Plus receiving unit is close to an active WLAN unit, some interference
could occur causing a loss of EMG data. Moving away the two units, the system
would work properly, at least one or two meters. Data loss is shown by the
corresponding “CH#” led that temporary switches off. Data loss is always
recognizable. In case of continuous loss of data and/or problems of acquisition, it

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will be necessary to move the frequency of the device responsible for the
interference to the highest available, and move the source of the wireless signal
away from Wave Plus of at least 3 meters.

How to use the device with disturbing electromagnetic fields

If strong electromagnetic fields are in the environment where Wave Plus works,
some interference could occur during the data transfer via USB, causing a loss of
EMG data. To make the system work properly, the USB cable has to be moved
away from the source of noise.

Use of the transportation Case

If the system is provided with a transportation case (blue flight case), it is recom­mended to always keep it with the downside facing downwards. The case can pro­tect the system only from very light shocks, so it is NOT to be considered as an ab­solute way of protecting it. Be sure to keep the key to the lock of the case in a safe
place and away from children.

How to remove the EMG probes positioned on the patient.

The cables with clip connections used by standard wireless units for EMG (see pa­ragraphs 3 and 3.1) are delicate and breakable elements of the system, not to be
submitted to continuous strains and tractions which could partially or totally dam­age them, with negative effects on the reliability of the EMG signal acquired. For
this reason, we suggest, during detachment of the probes, to uncouple the clips
from the pre-gelled electrodes, directly handling the clips and without stretching

the cables, before proceeding to the complete removal of the EMG probe.

Safety risk:

The simultaneous connection of a patient to both a high frequency chirurgical de­vice and an EMG system can cause burns where the electrical stimulation or biopo­tential input takes place, and can possibly cause damages to the pre-amplifiers.

More warnings:

Do not use Wave Plus system in an environment with inflammable anaesthetic
mixture with air or oxygen or nitrogen protoxide.

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Ask the patient if he/she is sensitive to electrode gel and to polycarbonate of the
external shell.

Do not use in presence of devices essentials to life support.

Due to the small dimension of some components, we suggest not to use the system
in children of less than 3 years of age or in non co-operative subjects. In these
cases use the system watching carefully and continuously the subject.

The main unit is supplied with three rubber antennas that have been selected and
certified by the producer to get the best result in every application; the use of dif­ferent antennas could cause malfunctions or could lead to exceed the specifications
of the FCC and CE certification of the device.

4.7 Piezoresistive sensors

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Piezoresistive sensors for the gait cycles events detection are placed under the foot surface, in a position
that allows a precise measurement of support and toe off. Up to four sensors for foot are available, and
these are displaced in the typical positions:

- Toe sensor n. 1

- First metatarsus, sensor n. 2

- Fifth metatarsus, sensor n. 3

- Heel, sensor n. 4

Sensors are not different from each other and they are numbered from 1 to 4 only to identify the applica­tion area.

The location and the positioning techniques can change according to operator’s preferences.
The connection to Footswitch electrode has to be done according to the following representation:

Proceed according to the following instructions:

1. Apply the sensor on the patient;

2. Identify the orientation of the FSW electrode socket;

3. Put the FSW sensor plug into the FSW electrode socket according to the number.

The four inputs are electrically and mechanically identical; to have correct data identification, inputs
are:

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The FSW sensor plug isn’t polarised and can be connected in both ways; the FSW electrode socket has

a white coloured label to make easier the numeric assignment of sensors.

If FSW has been wrongly connected, sensors will not work properly, but the sys­tem will not be damaged.

To avoid any damage of the sensors, we suggest sticking the dedicated circular
stickers on the grey side of footswitches (i.e., on the side with pressure sensors), as
in the picture below. The stickers application on the black side can damage foot­switches themselves.

5. SYSTEM MAINTENANCE

5.1 Repairable parts

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Wave Plus system does not contain parts repairable by the user with the exception of the batteries; for
standard maintenance see the following chapters.

5.2 Replacement of electrode battery

After about 300 charging/discharging cycles, the battery could reduce its electric capacity that leads to a
shorter time of use of the electrodes. To re-enable the normal efficiency, replace the battery module as
follow:

1. Open the
probe by
gently push­ing as shown
in the pic­ture. The
probe will
slide open
separating in
two parts
(lower and
upper).

2. Take the
lower part of
the probe, the
one containing
the battery. As
shown in the
picture, the
battery is
linked to the
probe with a
small connec­tor.

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3. Extract the
battery after
gently prying it
out of the
housing as
shown in the
picture.

4. After having
removed the
battery, pull
the connection
cable
VERTICALLY in
order to detach
the connector
from the
probe.

5. The ex­hausted Li-ion
battery will
have to be dis­posed of ac­cording to your
country’s regu­lations

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6. Take the
new battery
and follow the
same steps
backwards to
install it inside
the probe.

7. Carefully in­sert the new
battery, mak­ing sure it is
positioned as
shown in the
picture.

8. Put the
probe back to­gether by slid­ing the upper
part back into
the lower one,
as shown in the
picture, until
you hear a
click.

5.3 Electrode battery characteristics

Voltage: 4V
Capacity: 150 mA/h
Type: LI – ION rechargeable battery
Max. Recharging cycles: 300 (80% residual capacity)

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The battery has a label as follow:

REF.: WBAT (component code)
Lot.: AANN-N, where AA is the production year, NN is the production lot, -N is the

traceability code.

Use of non original batteries

Change the exhaust batteries with original ones supplied by Cometa. Use of non
original batteries could cause damage to the unit and safety risks for patient and
operators; use of non original batteries will make the warranty void.

You can find the battery at:

Cometa srl
Via Verdi 24
20080 Cisliano MI
Tel. [phone]
[e-mail]

The replacement of the battery of the foot-switch electrode is performed in the same way.

5.4 Warnings about electrodes battery

5.4.1 General warnings

Warning: DO NOT disassemble the battery.

Warning: DO NOT short-circuit the battery terminals.

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Warning: DO NOT cut or drill the battery container; the electrolyte is dangerous for hu-

man body. If you touch the electrolyte, immediately wash the part with water
and call a doctor.

Warning: DO NOT burn down or put the battery in the fire.

Warning: DO NOT use electrodes with battery that is losing electrolyte, or smells of elec-

trolyte, or has the container blown up.

Warning: Electrodes that are losing electrolyte or smells of electrolyte have to be kept

away from fire.

Warning: Check the storing modalities, working and recharging temperature in chapter

“Technical Specifications”

5.4.2 Warnings for battery disposal

The power supply module contains a rechargeable battery; for its disposal observe
local and national limitation for lithium battery.

5.4.3 Warnings for device disposal

Base unit, electrodes and optional of the Wave Plus system have to be disposed off
complying with national and local limitation for electronic devices and with Euro­pean Directive 2002/95/CE, 2002/96/CE, 2003/108/CE.

5.5 Replacement of worn parts

In Wave Plus system, the parts that could result worn after usage are:

1. Terminals and clips of EMG electrodes; check monthly clips and wires; if the wire is worn,

replace the lower EMG module;

2. Terminals and clips of foot-switch electrodes; check monthly the connector of piezoresistive

sensors and wires; if the wire is worn, replace the FSW lower module.

5.6 Wave Plus cleaning

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To clean Wave Plus system components use a soft cloth damped with neutral soap. System components
are NOT protected by liquid infiltration.

The cleaning of the system elements has to be done:

1. Base unit: every six months or more often if required

2. Electrodes: every 50 hour or more often if required

Warning:

Liquid infiltration can cause the EMG signal amplitude reduction, or the interruption of the electrode
functioning. In these cases, proceed as follow:

- Take off the acquisition module (upper part) from the battery module, as described in

“Replacement of electrode battery” chapter;

- Remove the liquid with a dry cloth;

- Dry out the modules using a low temperature source (radiator or oven at maximum 30°C);

If the problem persists, replace the electrode.

5.7 References

In the event of non-functioning, breakdown or other problems dealing with Wave Plus system, please
contact:

Cometa srl
Via Verdi 24
20080 Cisliano MI
Tel. [phone]
[e-mail]

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6. LABELS

6.1 Base Unit:

Label composition:

REF.: REFERENCE NUMBER
LOT.: PRODUCTION LOT IDENTIFIER
S.N.: PRODUCT SERIAL NUMBER

6.2 Brief case with charger:

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6.3 Inductive charger (inside the brief case, up to two units):

6.4 Elettrodi:

The electrodes are made of two parts; the upper part is permanently pad printed with the brand “Wave

Plus” on the top. The lowe part is permanently pad printed with the brand “Cometa” on one side and

“Wave Plus” on the other side.

To the upper part is applied an adhesive label as follow:

<EMG CH#> or <FSW #>

with the number assigned to the electrode (from 1 to 16), or to the FSW (“A” or “B”).

The labels of the two parts of the electrodes are visible after having taken apart the probe by separating
the upper and the lower part

To the upper part is applied a label with these informations:

REF XXX

LOT XXXX

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where REF. (three to six characters) is the Product Code and LOT. (four characters) is the production lot,
for example 1201 = year 2012, lot nr. 1.

On the battery there is the following label:

SEE MANUAL FOR LI-ION

BATTERY REPLACEMENT

Ref: WBAT

Lot: 1201-1

where REF. is the Product Code (WBAT) of the battery, and LOT. (six characters) is the production lot,
for example 1201-1 = year 2012, lot nr. 1, traceability code nr. 1

The lower part of the probe (PSC power supply module), once removed the battery, shows the code:

XXXXXX XXXX

Where the first field (from three to six characters) is the code of the item (for example, WPPSC: power
supply of Wave Plus) and the last 4 elements is the year and the lot of production (for example, 1101 =
year 2011, lot nr. 1).

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7. TECHNICAL SPECIFICATIONS (WAVE PLUS 16 CH)

Base unit

Transmission / Reception frequency 2402 – 2480 MHz
Transmission power (ARP) 0,45 mW
Number of channels (16 EMG + 48 ACC + 2 FSW) 66
Power supply (stand alone, external wall plug medical grade SMPS) 9 Vcc +- 10%
Power supply (PC connected) via USB
Absorbed power 2 W
Operating temperature range 0 + 50 °C
Input:
Start trigger TTL, max ±10 V
Trigger out TTL, max ±10 V
Output:

EMG Output ± 2,5 V, Zout = 100 ohm
ACC Output ± 2,5 V, Zout = 100 ohm
FSW Output 16 levels, max 3 V

Host USB link: USB 2.0
Gain (EMG channels) 1.000 (1V/mV)
Dimension 155 x 105 x 50 mm
Weight 300 gr.

EMG Module

Transmission / Reception frequency 2402 – 2480 MHz
Transmission power (ARP) 0,45 mW
Power supply voltage 4 Vcc
Absorbed power 40 mW
Operating temperature range 0 + 50 °C
Full charge operation time (100% charged battery) >12 h

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Stand by time (100% charged battery) > 180 gg.
EMG input +- 2.5 mV

bandwidth 10 Hz – 500 Hz (or 1 KHz)

sampling 16 bit – 2 Ks/sec.
ACC sensitivity (SW selectable, full scale) ±2 g, ±4 g, ±8 g, or ±16 g.
bandwidth DC – 70 Hz
sampling 10 bit – 142.8 s/sec.

Max. allowed acceleration 10,000g
Dimensions 33 x 23 x 19 mm.

Weight 12 gr.

FOOTSWITCHES Module

Transmission / Reception frequency 2402 – 2480 MHz
Transmission power (ARP) 0,45 mW
Number of FSR sensors 4
Power supply voltage 4 Vcc
Absorbed power 40 mW
Operating temperature range 0 + 50 °C
Full charge operation time (100% charged battery) > 12 h
Stand by time (100% charged battery) > 180 gg.
FSW input for piezoresistive sensors
Dimensions 33 x 23 x 19 mm.
Weight 12 gr.

Docking Module

Recharging capacity 20 modules
Power supply voltage 9 V +- 10%
Maximum absorbed power 13.5 W
Recharging time 7.5 h (auto shut off)
Dimension embedded into the Wave

Plus briefcase

Net feeding

Power supply voltage 100 – 240 V 50/60 Hz
Output voltage 9 V cc, 1,5 A

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Power supply cable 2,1x5,5 S 11,5 coax (+central)

Additional specifications

Input impedance: 20MOhm
CMRR: >120dB (true differential electrodes without reference elec

trode);

SNR: >50dB;
Hardware filtering (LP and HP): 1st order, 6 dB/octave

Environmental conditions:

Ambient temperature when charging: 0°C /+40 °C
Relative damp when operating: < 85 % RH
Storage relative damp < 85 % RH

Storage temperature -20°C/ +35°C
Storage pressure 500/1060 hPa

7.1 Suitability

For a correct functioning of the radio link between the electrodes and the base unit, the relative distance
has to be less than 20 meters.