vygon Plexygon User manual

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User manual / Manuale d’uso / Manuel de l’utilisateur
Benutzerhandbuch / Manual de usuario

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11c
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1a
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1.Cable electrico con enchufe tripolar (1a),
Conector de electrodo (1b)y Conector de
Aguja (1c).
2.Display
a.Corriente or carga;
b. Sonido (activado o desactivado);
c. Función de precision para regulaciones
finas (activado); d. Control lateral (activado);
e. Unidad de medida seleccionable;
f. Regulación botón gitatorio (activado);
g. Opciones de frecuencia seleccionables;
h. Opción de duración de impulso
seleccionable;
i. Unidad de medida seleccionada;
k. Indicador de batería agotada
3.Botón giratorio para regulación de corriente
or carga aplicada
4.Botón configuración menú o de modificación
de la duración del impulso
5.Control lateral para regulación de corriente o
carga suministrada
6.Tasto Safety di azzeramento corrente erogata
7.Botón ON/OFF
8.Compartimento batería (en la parte baja
posterior del producto)
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1.Cavo elettrico con presa tripolare (1a),
Connettore per elettrodo (1b)e Connettore
per ago (1c).
2.Display
a. Corrente o quantità di carica impostata;
b. Tonalità sonora (attivata o disattivata);
c. Funzione di precisione (attivata);
d. Regolazione tramite Side control (attivato);
e. Unità di misura selezionabili;
f. Regolazione tramite manopola (attivata);
g. Impostazione della frequenza;
h. Impostazione durata impulso;
i. Unità di misura selezionata;
k. Indicatore di batteria scarica
3.Manopola regolazione corrente erogata
4.Tasto modifica menù o Modifica durata di
impulso
5.Controllo laterale per regolazione di corrente
o quantità di carica erogate
6.Tasto Safety di azzeramento corrente erogata
7.Tasto di accensione/spegnimento
8.Vano batteria (nel retro dell’apparecchio)
ITALIANO - pag. 21-40
1.Câble électrique avec trois connecteurs (1a),
Électrode (1b)et Aiguille (1c).
2.Ecran
a.Courant ou charge;
b. Son (activé ou désactivé);
c. Précision (activée);
d. Commandes latérales (activées);
e. Sélection de l’unité de mesure;
f. Bouton de réglage (activé);
g. Sélection de la fréquence;
h. Élection de la durée de stimulation;
i. Unité de mesure choisie;
k. Indicateur de batterie.
3. Bouton de réglage de l’intensité
4.Sélection du mode
5.Bouton latéral pour le réglage de l’intensité
6.Bouton d’arrêt d’urgence de la stimulation
7.ON/OFF
8.Logement batterie (au dos de l’appareil)
FRANÇAIS - pp. 41-60
1.Dreipoliges Kabel (1a), Elektrodenanschluss
(1b)und Kanülenanschluss (1c).
2.Anzeige
a.Elektrische Stromstärke oder Ladung;
b. Tonsignale (aktiviert oder deaktiviert);
c. Präzisionsanwendung für die
Feineinstellung (aktiviert);
d. Seitentasten (aktiviert);
e. Auswählbare Maßeinheiten;
f. Einstellung über Drehknopf (aktiviert);
g. Auswählbare Frequenzen;
h. Auswählbare Impulsdauer;
i. Eingestellte Maßeinheit;
k. Batteriekontrollanzeige
3.Drehknopf zur Einstellung der elektrischen
Stromstärke oder Ladung
4.Modustaste oder Taste zur Auswahl der
Impulsdauer
5.Seitentasten zur Einstellung der elektrischen
Stromstärke oder Ladung
6.Sicherheitstaste um die elektrische
Stromstärke oder Ladung sofort auf Null
zu setzen
7.AN/AUS Taste
8.Batteriefach (untere Rückseite des Geräts)
DEUTSCH - S 61-80
1.Electric cable with three poles plug (1a),
Electrode lead (1b)and Needle lead (1c).
2.Display
a.Current or charge;
b. Sound tones (enabled or disabled)
c. Precision feature for fine adjustments
(enabled);
d. Side control (enabled);
e. Units of measurement selectable options;
f. Rotating knob regulation (enabled);
g. Frequency selectable options;
h. Impulse duration selectable options;
i. Unit of measurement selected;
k. Exausted battery indicator
3.Rotating knob for adjustments of current or
charge supplied
4.Set up button or Modification of impulse
duration button
5.Side control for adjustments of current or
charge supplied
6.Safety button to zero immediately the current
or the charge supplied
7.ON/OFF button
8.Battery panel (in the back lower side of the
device)
ENGLISH - pp. 1-20
ESPAÑOL - pp. 81-100

1
ENGLISH
INDEX
1. OVERVIEW ................. 2
1.1 Intended use ............... 2
1.2 Warnings ................ 2
2. FUNCTIONING OF THE STIMULATOR ...... 4
2.1 Set up of the stimulator ............ 4
2.1.1 Check list of the parts .......... 4
2.1.2 Battery installation / change ......... 4
2.1.3 Cables connection ............ 4
2.2 Stimulator’s switch on / off ............ 4
 2.3Setupmodication .............. 5
2.4 Current / charge selection ............ 5
2.5 Display ................. 6
2.6 Side Control ................ 7
2.7 Safety features ................ 7
2.7.1 Current self limitation at switching on ...... 7
2.7.2 Sound tone .............. 7
2.7.3 Set / supplied current ........... 8
2.7.4 Disconnection alarm ........... 8
2.7.5 “Safety” button ............. 8
2.7.6 “Precision” feature ............ 8
2.7.7 Exhausted battery ............ 8
2.7.8 Self switching off ............ 9
3. INSTRUCTIONS FOR USE ........... 9
3.1 Use of the device ............... 9
3.2 Check of the functioning ............ 10
3.3 Conditions of use, cleaning and maintenance ...... 10
3.4 Accessories................. 11
4. TECHNICAL DATA .............. 12
4.1 General information .............. 12
4.2 Output waveform............... 12
4.3 Precision ................. 13
 4.4Classication ................ 13
4.5 Liability ................. 13
4.6 Waste disposal and conformity to the WEEE directive ... 14
4.7 Transport and storage ............. 14
4.8 Batch and year of manufacturing .......... 14
4.9 Electromagnetic compatibility ........... 15
5. REGULATORY ISSUES............. 19
5.1 Applied standards .............. 19
5.2 Declaration of conformity ........... 19
6. WARRANTY ................ 20

2
1. OVERVIEW
This device is manufactured according to current International safety standards.
Please carefully read the following warnings,instructions and safety information
before using the device as recommended by the symbol printed on the
device.
1.1 Intended use
Plexygon is an electronic medical device aimed to provide the anaesthetist,
practising peripheral anaesthesia or pain therapy, with an instrument allowing an
easier and more precise localisation of the nerve. Nerve location is achieved by
generating an appropriate electrical stimulation, through a dedicated needle-
electrode, then inducing a muscular reaction on the afferences of the nerve
reached by the stimulation. The PLEXYGON stimulator has been designed to
obtainthebestperformancesintermofreliability,userfriendliness,efcacyand
safety.
1.2 Warnings
The warning notes are marked along the following paragraphs by the
symbol
Check of the functioning
- If Plexygon is not working as described in this manual, don’t use the device
and call for technical assistance.
- The user must make sure that the device is safe and integral before using it.
Carryoutvericationsasspecied(seeparagraph3.2).
- If at the time of switching on the display is any different from what is
described, the stimulator is not suitable for the use.
- If the symbol of battery is blinking, this means that the battery is not charged
enough and must be changed.
Use of the stimulator
- Thestimulatormustbeusedbyqualiedpersonnelandonlyaftercompletely
reading the enclosed manual of instructions for use. These personnel must
also have a sound knowledge of anatomy and neuro-physiology, and
knowledge of the protocols in force for the execution of peripheral blocks
(seeparagraph3.1).
- The injection of anaesthetic drugs causes a variation of the nerve response
to the stimulation; therefore after the injection it will not be possible to
maintain the stimulation at the same levels of current.-Always test for
aspiration of blood before any injection.
- Using lower charge allows further precision but implies higher risks of direct
contact with the nerve.
- If the sound tone has been deactivated, check the display to make sure that
thecurrentiseffectivelysuppliedtothepatient(seepar.2.7.2).
- Sincethedeviceisnotsupposedtobesterile,donotbringitinasterileeld

3
ENGLISH
nor get it in touch with sterile personnel.
- The use of the stimulator can interfere with the functioning of Pacemakers or
other stimulators implanted or anyhow connected to the patient. Therefore
don’t use the stimulator without consulting a specialist of these devices.
- Mobile,radiofrequencycommunicationdevices(includingcablesforexternal
antennasandantennas)mustnotbeusedcloserthan30cm(12inches)to
any part of the device, including the cables specied by the manufacturer.
Otherwise, the performance of the device may be affected.
- Useofthisdevicenearorover(aboveorbelow)otherdevicesisprohibited
as it may cause improper functioning. If this type of use is necessary, the
device in question and the others involved must be closely monitored to
verify their correct functioning.
- The simultaneous connection of the patient to a surgical high frequency
device can cause burns in correspondence to the electrodes of the stimulator,
or anyway damages to the stimulator itself.
- Don’tusethestimulatorinpresenceofflammablegases.
- Verify that the cables don’t touch with other cables or directly with the patient.
- Don’t use the stimulator in case of any malfunctioning, leakage of battery
fluids,accidentalpouringofliquidsonthestimulator.
- Don’t use non-original accessories.The use of non-original accessories can
modify the emission of the electrical impulse, increase electromagnetic
emissions and/or decrease the electromagnetic immunity of the device and
consequently affect the safety features of the stimulator itself.
- Do not act near microwave and/or short waves therapy devices.
- Highriskofcardiacbrillationduetoapplicationofelectrodesinthethoracicarea.
- Check the compatibility between the device and its accessories and handle
with particular care.
- The stimulation should not be applied across or through the head, directly on
theeyes,coveringthemouth,onthefrontoftheneck(especiallythecarotid
sinus),orfromelectrodesplacedonthechestandtheupperbackorcrossing
over the heart.
- Do not touch the battery contacts and the patient at the same time.
- To reduce the risk of liquid leakage from the battery, remove the battery
from the device when not in use for a long time.
Cleaning and maintenance
- The stimulator must be cleaned by a soft cloth dampen with natural water;
it’s possible to use also degreasing or sterilizing substances. The usage of
ethylic alcohol is NOT allowed.Don’t use sprays nor immerse the stimulator
in any liquid.
- A spilling or a stagnation of liquid or humidity on the device can cause a
malfunction of the stimulator, therefore it is important to avoid any spills of
liquid on the stimulator. In case of accidental spilling mop carefully any
eventual residue.
- For the device disposal please refer to the instructions in paragraph 4.6.

4
2. FUNCTIONING OF THE STIMULATOR
2.1 Set up of the stimulator
2.1.1 Check list of the parts
Verify that inside the case, further to the stimulator, the following
accessories are included:
- 1 cable for connecting the stimulator to the needle.
- 1alkalinebattery9V-500mAh(type6LR61);
2.1.2 Battery installation / change
Open the panel in the back lower side of the stimulator by gently
pushing on the lever of the panel itself and pulling upwards.
Thenconnectanalkalinebattery9V-500mAh(type6LR61)totheclip
inside the battery room, caring of the proper connection of the positive
and negative poles. Insert the battery in its room and close the panel
with a procedure opposite to the opening one.
2.1.3 Cables connection
Once the battery has been inserted and the back panel closed, set up
the double lead cable by inserting the three poles plug in the stimulator’s
front socket. Thereafter connect the BLACK lead in to the needle
(negativeelectrode;blackplug)andtotheECGelectrodeREDleadon
the patient electrode.
2.2 Stimulator’s switch on / off
To switch the stimulator on, press the ON / OFF button on
the front panel.
By that the display will show the default set up: the current
associatedtothesuppliedimpulse(0,00mAattheswitching
on),thefrequency(2Hz)andthedurationofthestimulus
itself(300µS).
Before proceeding further, it’s recommended to verify the proper
functioning of the stimulator according to the modalities described in
par.3.2(Checkofthefunctioning).
To switch the stimulator off, keep the ON/OFF button pressed for 2 sec.

5
ENGLISH
2.3 Set up modification
µs
MODE
To modify the set up of the stimulator, keep the µS/MODE button
pressedfor2sec.Onceenteredinthemenu,themodiableparameter
is pointed: then it’s possible to change the setting by rotating the knob
clockwiseoranticlockwise.PressingagaintheµS/MODEbutton,the
selectionisconrmedandthenextparameterisselected.
The sequence of the selection is the following:
Frequency: Selectable options: 2 - 1 - 4 Hz
Duration: Selectableoptions:300-50-100µS
Measure unit: Selectable options: mA - nC
Sound: Selectable options: on - off
A further push of the MS/MODE button allows to go out from the options
menu and return to the normal functioning.
During the functioning of the stimulator, it is possible to modify the duration of
the impulse keeping constant the charge supplied (expressed in nC) with a
pressureandanimmediatereleaseoftheµS/MODEbutton.Ifthevisualisation
is in mA, the current will change in order to keep constant the charge supplied
(forexample:duration300µS-current0.5mA;modieddurationto100µS-
currentto1.5mA;modieddurationto50µS-currentto3.0mA)
2.4 Current / charge selection
The knob on the upper right side of the front panel allows
adjustment of the current or the charge supplied by the stimulator
at any impulse.
At each rotation step, the selected current will change by 0.1 mA
or 0.02 mA respectively if its value is bigger or lower than 0.5 mA;
turning the knob clockwise the current increases, turning anticlockwise the
currentdecreases.Duringtheneadjustments(under0,5mA)thesymbol“P”
(Precision)appearsonthedisplay.
NOTE: If the visualization in “nC” has been selected, the charge variation step
is equal to the product of the current multiplied by the duration of the impulse,
corresponding then to the values indicated in the table here below:
Table 1:Variation steps of the charge Q (nC) for different durations of the
impulse
300 µS 100 µS 50 µS
Q150 nC 30 nC - -
Q150 nC 6 nC - -
Q75 nC - 10 nC -
Q75 nC - 2 nC -
Q25 nC - - 5 nC
Q25 nC - - 1 nC

6
The range of selectable current is:
from0to4mAforimpulsedurationof300µs(or0to1200nC),
from0to5mAforimpulsedurationof100µs(or0to500nC),
from0to6mAforimpulsedurationof50µs(or0to300nC).
Each delivered impulse is accompanied by a sound.
The sound has a tone increase each 0,1 mA between 1,0 and 0,5 mA.
For safety reasons it is not possible, for any current or duration,to set a current
higher than 2,0 mA (or an equivalent charge) before the needle has been
introducedinthepatient(seepar.2.7.1)
2.5 Display
IThe display is used either for the
visualization of the current or charge
associated to each impulse, and for
showing the selected parameters of
functioning (duration of the impulse,
frequency, measure unit of the
visualization, active selector, and
eventualbatteryalarm).
The visualized gure corresponds to
the impulse actually supplied by the
stimulator, apart from when the knob
is turned. In this case the gure shown corresponds to the selected gure
during the adjustment and for the following four seconds.
If the supplied current differs from the selected one by more than 0,02 mA, the
gureonthedisplaywillblink.
In case of the disconnection of the cable from the needle or the ECG electrode,
(otherwiseincaseoftheextractionoftheneedlefromthepatientskin,)the
current will turn to zero, the display blinks and the stimulator generates a
continuous sound.
If the needle has not been inserted in the patient yet, after four seconds the
gureonthedisplaywillturntozero(suppliedcurrent)andwillstartblinking
but without the alarm sound.
On the upper left part of the display, the battery indicator will illuminate and
blinkifthebatterychargestartstobeinsufcienttograntaproperfunctioning
of the stimulator.
Sincewhenthelowbatteryindicatorlightsonthersttime,thedevicecanstill
operate for at least two hours of continuous utilization.
The display shows the selected parameters and which is the active selector for
current/chargeadjustment(knoborsidecontrol).
The “P” letter lights on when the stimulator automatically passes to“Precision”
µS/MODE(seepar.2.7.6).

7
ENGLISH
2.6 Side Control (alternative to rotating knob for adjustments)
SLIDE
CTRL
The side control buttons can be activated by pressing and holding
on the arrow the for at least 2 sec.
Its activation exclude the rotating knob from the possibility to
adjust the current / charge: on the display this condition is
highlighted by the disappearing of the symbol and the appearing
of the symbol.
The side control takes over the function of the rotating knob: each pressure on
the arrow part of it corresponds to a clockwise step of the knob;each pressure
on the lower part of it corresponds to an anticlockwise step of the knob.
Keeping the lower or the upper button of the side control pressed,the current
/ charge will be adjusted continuously.
The utilization of the side control is particularly useful when the stimulator is
usedwithinasterileeld,withitsprotectionbag(suppliedseparately),orfor
one hand manipulation.
Once the side control is activated,in order to deactivate it the stimulator must
be switched off.
2.7 Safety features
2.7.1 Current self limitation at switching on
For safety reasons, the stimulator will not permit excessive currents before the
needle has been inserted into the patient. Therefore, independently from the
selected duration of the impulse, it will not be possible to initially set a current
higherthan2,0mA(oranequivalentcharge).
Once the needle has been inserted into the patient, it’s possible to select
currents higher than 2,0 mA, as described in par. 2.4.
2.7.2 Sound tones
IThe stimulator generates a sound synchronized to the electrical
impulsesuppliedtothepatient(thenattheselectedfrequency)
The tone of this sound remains unchanged for any current higher
than1,0mA(orequivalentchargevalues)
When the current setting is reduced the sound increases by one
toneeach0,1mAofreductionupto0,5mA(highesttone).
Forcurrentslowerthan0,5mA(orequivalentcharge),thereached
tone keeps unchanged.
Fromthemenuofsetupmodication(point2.3)itispossibletodisactivate
the sound during normal functioning. In that case the symbol will be crossed.
If the sound tone has been deactivated, check the
display to make sure that the current is effectively
supplied to the patient.
It is not possible to disactivate the alarm sounds.

8
2.7.3 Set / supplied current
The stimulator provides continuous and automatic check and adjustment of the
supplied current to the selected one.The visualized current is then the selected
one but also the supplied one, apart from the rst four seconds from the
variationoftheselectedcurrent.(seepar.2.5).
In case of peaks of resistance preventing the stimulator from actually supplying
theselectedcurrent,thevisualizedgurewillblink*andwillbetherealone
supplied.
If the needle has not been introduced into the patient yet, after four seconds
thegureonthedisplaywillturntozero(suppliedcurrent)andstartblinking,
but without any sound alarm.
2.7.4 Disconnection alarm
In case of disconnection from the needle or the ECG electrode, the displayed
current turns to zero and blinks, and the stimulator generate a continuous tone.
2.7.5 “Safety” button
At any moment it’s always possible to turn the current / charge immediately to
zero by pressing the “Safety” button.
The pressure of the “Safety” button, further than turning to zero the supplied
current, activates also a protection circuit turning the high tension generator
circuit off and short circuits the output of the stimulator; to re-activate all
circuits, the knob must be turned clockwise.
Pressing only the “Safety” button keeps all other set parameters unchanged.
2.7.6 “Precision” feature
The search for the nerve does not require an absolute precision.Therefore the
stimulatorqualieshighervariationsteps(0,1mA)fortheadjustmentofthe
current/charge(seepar.2.4)inordertoavoidthattoomuchturnsoftheknob
are required for obtaining starting current values.
On the contrary, the ne adjustment of the needle tip position requires
reduced values of the charge / current.Therefore the stimulator automatically
qualiesaneregulation(stepsof0,02mA)ifthecurrentissetlowerthan0,5
mA(orequivalentcharge,aspertable1par.2.4).
When the “Precision” feature is activated, the letter P is shown on the display.
2.7.7 Exhausted battery
On the upper left part of the display, the battery indicator will illuminate and
blink if the battery charge starts to be insufcient to grant the proper
functioning of the stimulator.
However when the low battery indicator lights when the on button is activated,
the device can still operate for at least two hours of continuous utilization.

9
ENGLISH
At this time the battery should be changed as soon as possible, and before
proceeding with further blocks.
2.7.8 Self switching off
If the set current is set at zero for 15 minutes without any further ajustment
on any stimulator selector, the stimulator will automatically switch off.
3. INSTRUCTIONS FOR USE
3.1 Use of the device
The stimulator must be used by qualified personnel and only
after completely reading the enclosed manual of instructions
for use. These personnel must also have a sound knowledge
of anatomy and neuro-physiology, and knowledge of the protocols
in force for the execution of peripheral blocks.
The recommended approach is the following:
- start the search with impulses of relatively high intensity: for most cases an
impulseof300µsofdurationwithachargeof300÷600nC(1.0÷2.0mA)
is recommended;
- once the searched nerve has been identied, decrease progressively the
intensity of the stimulus up to 90 - 150 nC (0.3 - 0.5 mA) in order to
improve the position of the needle tip;
- if necessary, the precision of the positioning of the needle tip can be further
improvedbydecreasingthecurrent/charge(in thiscase the“Precision”
feature will be automatically activated), or by selecting shorter impulse
durations(100or50µS)
- once the required muscle contraction has been identied with the
appropriated charge, following aspiration with a syringe, it’s possible to inject
atestdoseofanaestheticdrug(around1ml).
The injection of anaesthetic drugs causes a variation of
the nerve response to the stimulation; therefore after
the injection it will not be possible to maintain the
stimulation at the same levels of current.
Always test for aspiration of blood before any injection.
Using lower charge allows further precision but implies
higher risks of direct contact with the nerve.
Once veried that the test dose has been successful, inject the full dose
required.

10
Search with the same method all components of the nerve necessary for the
complete execution of the block.
Since the device is not supposed to be sterile, do not bring
it in a sterile field nor get it in touch with sterile personnel.
3.2 Check of the functioning
When the stimulator is switched on,all default parameters appear on the display:
300µs relevanttotheselectionofadurationof300µs;
2 Hz relevant to the selection of a frequency of 2 Hz;
mA relevant to the selection of measure unit;
ThegureshownontheLCDdisplaywillbe0000iftheselectedunitisnCor
0.00 if the selected unit is mA.
If at the time of switching on the display is any different from
what is described, the stimulator is not suitable for the use.
If the symbol of battery is blinking, this means that the
battery is not charged enough and must be changed.
With the cable connected to the stimulator it is possible to verify that the
device is working properly.To do so, adhere to the following procedure:
- to adjust the current or the charge; rotate the knob, verify that the value
seen on the display is the desired value/setting.The screen will return to
zero after about four seconds. By rotating the knob rapidly clockwise and
anti-clockwise, you can linearly adjust the current setting; by rotating the
knob slowly, a single click at a time, either clockwise or anti- clockwise, the
corresponding value is displayed on the screen; verify that the sound tone
whichindicatescurrentsupply isclearly audible, and there isnoflashing
symbol of an exhausted battery;
- connect the output male plug of the cable (black wire) to the crocodile
connectionoftheinputcable(redwire);verifythat,adjustingthecurrentor
chargebyrotatingtheknob,thegureonthedisplayistheselectedone,
afterfoursecondsfromtherotationoftheknob,andstaysstill(notblinking).
If the result of the check has been positive, the stimulator can be used safely.
3.3 Conditions of use, cleaning and maintenance
THE PLEXYGON STIMULATOR DOESN’T NEED ANY TYPE OF
PREVENTIVE MAINTENANCE.
In order to evaluate the proper functioning of the stimulator just follow the
instructions in paragraph. 3.2. When the stimulator is not in use, it’s
recommended to switching it off, so as to preserve the battery charge.
After use, the stimulator and its accessories have to be stored in the case

11
ENGLISH
If the stimulator will not be used for a long period of time, it’s recommended
to remove the battery and store it also in the case. If the battery symbol is
blinking, it means that the battery is exhausted and must be replaced as soon
as possible; it’s recommended to avoid the use of the stimulator in battery
exhausted condition. The exhausted battery must be removed from the
stimulator and discarded.
Accordingtotheelectricalmedicaldevicessecuritystandard(EN606011/A2),
we recommend to use the stimulator at a operating temperature between
10°C and 40°C and a relative humidity included between 30% and 75%.
The stimulator must be cleaned by a soft cloth dampen with
natural water;it’s possible to use also degreasing or sterilizing
substances. The usage of ethylic alcohol is NOT allowed.
Don’t use sprays nor immerse the stimulator in any liquid.
A spilling or a stagnation of liquid or humidity on the device
can cause a malfunction of the stimulator, therefore it is
important to avoid any spills of liquid on the stimulator. In
case of accidental spilling mop carefully any eventual residue.
Any technical modification of the device is not allowed,
technical interventions on the device can be performed by
Vygon Italy authorized personnel only to which the device
must be sent in case of malfunctioning.
It’s possible to sterilize the output cable by Ethylene Oxide sterilization at a
temperature not higher than 50°C.
3.4 Accessories
The stimulator has been designed for performing peripheral nerve blocks.To
this purpose, we have foreseen the utilization of the following accessories:
1. Electro-stimulation needle for the search of the nerve and the injection of
the anaesthetic drugs. The stimulation needle must be connected to the
stimulator’s black cable.This needle must comply to the Essential
Requirementsforeseenbythe93/42/CEEDirectiveonthebiocompatibility
and is not supplied with the PLEXYGON stimulator. For safety and
conformity reasons the approved needles are the “Locoplex” and
“Echoplex”needlesmanufacturedbyVygonS.A.-Ecouen(France).
2. Continuous Peripheral Nerve Block:similarly to the previous point,similarly
indwellingcathetersmustalsocomplywiththesameEssentialRequirements.
The approved sets are the “Techniplex”, “Multiplex” and “Silverstim”
manufacturedbyVygonS.A.-Ecouen(France).
3. Electrode ECG type, pre-gelled, to be connected to the red cable of the

12
stimulator. These electrodes are commonly available in the hospital, and
must comply with the guide ISO 10993-1 on the compatibility, and are not
supplied with the stimulator.
4. TECHNICAL DATA
4.1 General information
Powersupply: internalalkalinebattery9V,500mAh(6LR61);
Battery duration: more than 25 hours of continuous functioning;
Impulse frequency: 1 Hz, 2Hz, 4 Hz, selectable by the “µS/MODE”
button on the front panel.
Impulseduration: 50µs,100µs,300µs,selectablebythe“MS/MODE
“ button on the front panel.
Current impulse: adjustable by the knob on the front panel or the
side control:from 0.0 mA to 6.0 mA for duration of
50µS;from0.0mAto5.0mAfordurationof100
µS;from0.0mAto4.0mAfordurationof300µS.
Quantity of charge: adjustable by the knob on the front panel or the
sidecontrol:from0to300nCfordurationof50µS,
from0to500nCfordurationof100µS,from0to
1200nCfordurationof300µS.
Measure unit selection: mA or nC, selectable by the menu.
Display: LCD custom 4 digits and icons for the visualization
of the current, or the quantity of charge, and for the
set up of the stimulator.
Operatingtemperature: Room temperature between 10°C and 40°C and
relative humidity includes between 30% and 75%.
4.2 Output waveform
The output waveform has the typical course shown in the following gure,
where two cases with resistance of 1000 e 500 Ωare reported,with an impulse
durationof300µSandacurrentof1,0mA:
300 µs
R=1000 Ohm R=500 Ohm µs
0.5
1
V
5 6.6 10 15 20 KOhm
Limite di corrente per impulsi di 50 µs
Limite di corrente per impulsi di 300 µs
Area di funzionamento
a corrente costante
4
6
mA

13
ENGLISH
The maximum supplied current is the function of the resistance and of the
durationselected,asshowninthefollowinggure:
4.3 Precision
The total error on the current generation is of 0.2% + 5mV; it remains then
always lower than 0.02 mA in the whole range of variation.
The error on the measurement of the supplied current is of around 0.01 mA
in the whole range 0 - 6 mA. Therefore, when the user sets a current, the
generated current has a precision better than 0.02 mA but,due to the following
measurement error, the processor could even read a current with a difference
of 0.02 mA as regards to the set current.
Then, the alarm of delivered current different from the set current, shown by
the blinking value on the LCD display, starts for differences higher than 0.02 mA,
in order to avoid fault readings.
4.4 Classification
Internallypowered devicewhose appliedpart hasbeenclassied as
Type BF. Classication according to IEC 60529 norm: IPX0, i.e. not
protected against the ingress of liquids, degree of protection against
the ingress of solid bodies not evaluated. Not suitable for the use in
presenceofanaestheticmixturesflammablewithairoroxygenornitrogen
protoxide, suitable for continuous functioning.
4.5 Liability
The manufacturer is responsible for electrical safety of the device in normal
use,inusualconditionsandinconditionofrstfailure.
The liability on the safety, reliability and performances is only valid if:
-
the stimulator has not been tampered in any way, and all adjustments,
modicationsorrepairshavebeencarriedoutbyauthorizedpersonnelonly;
- the stimulator has been used in conformity of the present instructions
for use.
300 µs
R=1000 Ohm R=500 Ohm µs
0.5
1
V
5 6.6 10 15 20 KOhm
Current limit for pulses of 50 µs
Current limit for pulses of 300 µs
Functioning zone
at a costant current
4
6
mA

14
4.6 Waste disposal and conformity to the WEEE directive
The following information is supplied pursuant to the LEGISLATIVE
DECREEof14March2014,no.49,'Implementationofthe2012/19/EU
Directive on waste electrical and electronic equipment (WEEE)',
concerning the reduction in the use of hazardous substances in
electrical and electronic equipment as well as waste disposal.
The crossed-out refuse bin symbol, printed on the device or its package,
indicates that at the end of its useful life the product must be collected
separately from other waste.
The separate collection of this device at the end of its useful life is organised
and managed by the manufacturer. The user who wants to dispose of this
equipment will therefore need to contact the manufacturer and follow the
system the latter has adopted to allow the separate collection of the device at
the end of its useful life. An appropriate separate collection, leading to the
decommissioned equipment's subsequent recycling, treatment and
environmentally compatible disposal, will contribute to avoid possible negative
effects on health and the environment, and promotes the re-use and/or
recycling of the materials contained in the device.
Illegal disposal of the product by the user will result in the application of
administrative sanctions pursuant to existing legislation.
Outside of the EU: follow local regulations for the disposal of medical and
electronic equipment, including batteries.
4.7 Transport and storage
The device and its components do not need any particular temperature
conditions. However, before using the instrument, check that the operating
temperature corresponds to the point 3.3 of this manual.
4.8 Batch and date of manufacturing
Theyearofmanufacturingisinsertedinthebatchnumber(seelabelonthe
batteryroomcoverofthedevice).
Thebatchofmanufacturingiscomposedby6(six)characters(twolettersand
4numbers),respectivelyandasfollowssubdivided:
- therstletter:thetypeofdevice(PstaysforPlexygon)
- thesecondletter:thevariant(Astaysfor:principalvariantofPlexygon)
- the four numbers indicate:
- the rst two numbers: the year of the batch’s manufacturing (ex. 10
staysforyear2010)
- thethirdandforthnumber:weekofmanufacturing(ex.06staysforrst
weekofFebruary).

15
ENGLISH
4.9 Electromagnetic compatibility
Table 1 - Manufacturer’s declaration - Electromagnetic emissions
ThePLEXYGONisintendedforuseintheelectromagneticenvironmentspeciedbelow.
The customer and/or the user of the PLEXYGON should assure that it is used in an
electromagnetic environment as described below.
Emissions test Compliance Electromagnetic environment
guidelines
RFemission
CISPR11 Group 1
ThePLEXYGONusesRFenergyonly
for its internal function.Therefore, its
RFemissionsareverylowandare
not likely to cause any interference in
nearby electronic equipment.
RFemission
CISPR11 Class B
The PLEXYGON is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public power supply
network that supplies buildings used
for domestic purposes.

16
Table 2 - Manufacturer’s declaration - Electromagnetic immunity -
Enclosure port
Phenomenon
Basic EMC
standard or test
method
Immunity test
levels required
for Professional
healthcare
facility
environment
Compliance
test levels
Electrostatic
discharge IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
RadiatedRF
electromagnetic
elds
IEC 61000-4-3
3V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
3V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximityelds
fromRF
wireless
communications
equipment
IEC 61000-4-3 See Table 4 See Table 4
Ratedpower
frequency
magneticelds
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz

17
ENGLISH
Table 3 - Manufacturer’s declaration - Electromagnetic immunity -
Patient coupling port
Phenomenon Basic EMC
standard or test
method
Immunity test
levels required
for Professional
healthcare
facility
environment
Compliance test
levels
Electrical fast
transients /
bursts
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
Conducted
disturbances
inducedbyRFelds
IEC 61000-4-6
3V
0,15 MHz – 80 MHz
6V in ISM bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
3V
0,15 MHz – 80 MHz
6V in ISM bands
between
0,15 MHz and 80
MHz
80 % AM at 1 kHz

18
Table 4 - Test specications for enclosure port immunity to RF wireless
communications equipment according to IEC 61000-4-3
Test
Frequency
(MHz)
Band
(MHz) Service
Modulation
Maximum
power
(W)
Distance
(m)
Immunity
Test level
(V/m)
385 380 - 390 TETRA
400
Pulse
modulation
18 Hz 1,8 0,3 27
450 430 - 470 GMRS460,
FRS460
FM
± 5 kHz
deviation
1 kHz sine
2 0,3 28
710
704 - 787 LTE Band 13,
17
Pulse
modulation
217 Hz 0,2 0,3 9
745
780
810
800 - 960
GSM
800/900,
TETRA
800,
iDEN 820,
CDMA
850,
LTE Band 5
Pulse
modulation
18 Hz 2 0,3 28
870
930
1720
1700 - 1990
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band
1, 3, 4, 25;
UMTS
Pulse
modulation
217 Hz 2 0,3 28
1845
1970
2450 2400 - 2570
Bluetooth,
WLAN,
802.11
b/g/n,
RFID2450,
LTE Band 7
Pulse
modulation
217 Hz 2 0,3 28
5240
5100 - 5800 WLAN 802.11
a/n
Pulse
modulation
217 Hz 0,2 0,3 9
5500
5785
WARNING: Portable RF communications equipment (including peripherals such
asantennacablesand external antennas) shouldbeused no closer than30cm (12
inches)toanypartofthePLEXYGON,includingcablesspeciedbythemanufacturer.
Otherwise, degradation of the performance of this equipment could result.