COMETA WAVE PLUS User manual

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 separa-
tion, 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 appli-
cation 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.