Plexygon Instructions for Use rev 4

1. OVERVIEW... 1.1 Intended use... 1.2 Warnings... 2. FUNCTIONING OF THE STIMULATOR . . 2.1 Set up of the stimulator... 2.1.1 Check list of the parts... 2.1.2 Battery installation / change... 2.1.3 Cables connection... 2.2 Stimulator’s switch on / off... 2.3 Set up modification... 2.4 Current / charge selection... 2.5 Display... 2.6 Side Control... 2.7 Safety features... 2.7.1 Current self limitation at switching on. . 2.7.2 Sound tone... 2.7.3 Set / supplied current... 2.7.4 Disconnection alarm... 2.7.5 “Safety” button... 2.7.6 “Precision” feature... 2.7.7 Exhausted battery... 2.7.8 Self switching off... 3. INSTRUCTIONS FOR USE... 3.1 Use of the device... 3.2 Check of the functioning... 3.3 Conditions of use, cleaning and maintenance . . 3.4 Accessories... 4. TECHNICAL DATA... 4.1 General information... 4.2 Output waveform... 4.3 Precision... 4.4 Classification... 4.5 Liability... 4.6 Environmental instructions... 4.7 Transport and storage... 4.8 Batch and year of manufacturing... 5. REGULATORY ISSUES... 5.1 Applied standards... 5.2 Declaration of conformity... 6. WARRANTY... 17

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INDEX

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. 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; this goal is reached generating an appropriated electrical stimulation, 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, efficacy 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 verifications as specified (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 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 neurophysiology, 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. 18

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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 field 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. 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, 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 fibrillation due to application of electrodes in the thoracic area. Check the compatibility between the device and its accessories and handle with particular care.

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. 19

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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. ON/OFF 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.

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Set up modification To modify the set up of the stimulator, keep the µS/MODE button µs pressed for 2 sec. Once entered in the menu, the modifiable parameter MODE 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 confirmed 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; modified duration to 100µS current to 1.5 mA; modified 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 fine 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 Q  150 nC Q  150 nC Q  75 nC Q  75 nC Q  25 nC Q  25 nC

300 µS 100 µS 30 nC 6 nC 10 nC -   2 nC 21

50 µS 5 nC 1 nC

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2.3

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 figure corresponds to the impulse actually supplied by the stimulator, apart from when the knob is turned. In this case the figure shown corresponds to the selected figure 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 figure 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 figure 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 insufficient to grant a proper functioning of the stimulator. Since when the low battery indicator lights on the first 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). 22

2.6

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 The 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 modification (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. 23

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SLIDE CTRL

Side Control (alternative to rotating knob for adjustments) 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 field, 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.

2.7.3 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 first 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 figure will blink* and will be the real one supplied. If the needle has not been introduced into the patient yet, after four seconds the figure 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 qualifies 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 fine adjustment of the needle tip position requires reduced values of the charge / current. Therefore the stimulator automatically qualifies a fine 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 insufficient 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. 24

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.

3.1

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 identified, 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 identified with the appropriated charge, following aspiration with a syringe, it’s possible to inject a test dose of anaesthetic drug (around 1 ml).  he injection of anaesthetic drugs causes a variation of the T 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 verified that the test dose has been successful, inject the full dose required. 25

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3. INSTRUCTIONS FOR USE

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 figure 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 issued to the stimulator it’s possible to verify that the device is properly working. To do so, make the following: - adjust the current or the charge by rotating the knob: verify that the figure visualized on the display is the selected one, then turns to zero after about four seconds; 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 figure 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. 26

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. 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 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. 27

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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.

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 figure, where two cases with resistance of 1000 e 500 Ω are reported, with an impulse duration of 300 µS and a current of 1,0 mA: V

1 300 µs 0.5

R=1000 Ohm

R=500 Ohm

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µs

R=1000 Ohm

R=500 Ohm

µs

The maximum supplied current is the function of the resistance and of the duration selected, as shown in the following figure: mA Current limit for pulses of 50 µs

6

Current limit for pulses of 300 µs

4

5

6.6

10

15

20

KOhm

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 Device type BF (IEC EN 60601-1), internally supplied, not protected against penetration of water, not suitable for the use in presence of anaesthetic mixtures flammable 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 first 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, modifications or repairs have been carried out by authorized personnel only; - the stimulator has been used in conformity of the present instructions for use. 29

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Functioning zone at a costant current

4.6 Environmental instructions Pursuant to the European Directives 2002/95/EC, 2002/96/EC and 2003/108/EC, on restricting the use of hazardous substances in electric and electronic equipment and on the disposal of waste material, the crossed out wheelie bin symbol applied to equipment or packaging means that the product should be collected separately from other types of waste at the end of its useful life. A user that wishes to dispose of this product should therefore dispose it following the applicable laws or by contacting the supplier and following the instructions given with respect to the separate collection of obsolete equipment. Proper separate collection and the subsequent recycling, treatment and environmentally compatible disposal of discarded equipment is of help in avoiding possible negative effects for the environment and people's health and facilitates the re-use or recycling of the materials of which the equipment is made. Illegal disposal of this product by the owner will be subject to the sanctions as provided by current applicable laws. - The exhausted batteries must be discarded in the appropriate containers. 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 first 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 first 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 first week of February)

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5. REGULATORY ISSUES

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Directive 93/42/EEC and following amendments (2007/47/EEC included) UNI EN ISO 13485:2004 Medical equipment - Quality system management UNI EN 980:2008 Graphical symbols for use in the labelling of medical devices UNI EN ISO ISO 14971:2007 - Medical devices - Application of risk management MED.DEV 2.12-1 Rev. 6 “Guidelines on a medical device vigilance system” MED.DEV 2.7.1 Rev. 3 “Guidelines on Clinical Evaluation” CEI EN 60601-1:1990 Medical electrical equipment – General safety standards EN 60601-1/A2:1997 Medical electrical equipment – General safety standards. Amendment A2. EN 60601-1-2:1993 ed EN 60601-1-2:2001 Medical electrical equipment part 1: general requirements for safety. Collateral standard: electromagnetic compatibility - requirements and tests EN 60601-1-4:1997 Medical electrical equipment part 1-4: general requirements for collateral standard - Programmable electrical medical systems. EN 60601-2-10/A1:2001 Medical electrical equipment part 2: particular requirements for the safety of nerve

5.2 Declaration of conformity VYGON ITALY S.R.L. declares that the device PLEXYGON complies with 93/42/EEC Directive and further ammendments included in 2007/47/EEC concerning medical devices, according with the Essential Requirements of the Annex I. Therefore the medical device PLEXYGON has the CE marking CE 0051 (see below) according with Annex XII of the 93/42/EEC Directive.

0051

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5.1 Applied standards The following are the International regulations, European Union Directives and International Technical Standards that were followed to design, build and test Plexygon.

6. WARRANTY Vygon Italia s.r.l. guarantees a free assistance (workmanship and spare parts) for all failures deriving from manufacturing defect. For the period of the warranty please refer to the local Vygon subsidiary Warranty does not apply in case of failures due to falls, crashes, negligence, unsuitable or unauthorized maintenance, or anyhow attributable to a misuse of the device. Warranty is excluded also for wear and tear parts as batteries, cables, etc. Maintenance, under warranty or not, should be carried out exclusively by Vygon Italia s.r.l. or authorized centres. Warranty is excluded in case of interventions carried out by unauthorized thirds. In order to require warranty repairs, a sale invoice or other relevant document and the valid serial number of each device must be presented.

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4.8 Lot et date de fabrication L’année de fabrication est inclue dans le numéro de lot (voir l’étiquette sur le compartiment de la batterie au dos de l’appareil). Le lot de fabrication est composé de six caractères (2 lettres et 4 chiffres), disposés et définis comme suit: - la première lettre: type d’appareil (P pour Plexygon) - la deuxième lettre: variante (A: version de base du Plexygon) - les quatre chiffres désignent: - pour les deux premiers chiffres: l’année de fabrication du lot (par ex. 10 pour l’année 2010) - pour les troisième et quatrième chiffres: la semaine de fabrication (par ex. 06 pour la première semaine de Février, la sixième de l’année).

5.1 Normes appliquables L’appareil a té conçu et fabriqué en conformité avec les normes suivantes. Plexygon a été reconnu conforme par l’organisme notifié IMQ n° 0051; - Directive 93/42/EEC and following amendments (2007/47/EEC included) - UNI EN ISO 13485:2004 Medical equipment - Quality system management - UNI EN 980:2008 Graphical symbols for use in the labelling of medical devices - UNI EN ISO ISO 14971:2007 - Medical devices - Application of risk management - MED.DEV 2.12-1 Rev. 6 “Guidelines on a medical device vigilance system” - MED.DEV 2.7.1 Rev. 3 “Guidelines on Clinical Evaluation” - CEI EN 60601-1:1990 Medical electrical equipment – General safety standards - EN 60601-1/A2:1997 Medical electrical equipment – General safety standards. Amendment A2. - EN 60601-1-2:1993 ed EN 60601-1-2:2001 Medical electrical equipment part 1: general requirements for safety. Collateral standard: electromagnetic compatibility - requirements and tests - EN 60601-1-4:1997 Medical electrical equipment part 1-4: general requirements for collateral standard - Programmable electrical medical systems. - EN 60601-2-10/A1:2001 Medical electrical equipment part 2: particular requirements for the safety of nerve 47

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5. RÉGLEMENTATION