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52502797IU9C / 2020-10
2797
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IT
EN
ELETTRODI MULTIFUNZIONE MONOUSO EURODEFIPADS®
DISPOSABLE MULTIFUNCTION ELECTRODES EURODEFIPADS
®
FR
DE
NL
ES
PT
RU
EL
SV
HR
ÉLECTRODES MULTIFONCTIONS À USAGE UNIQUE EURODEFIPADS®
®
MULTIFUNKTIONS-EINWEGELEKTRODEN EURODEFIPADS
MULTIFUNCTIONELE WEGWERPELEKTRODEN EURODEFIPADS
®
ELECTRODOS MULTIFUNCIONALES DESECHABLE EURODEFIPADS®
®
ELÉTRODOS MULTIFUNÇÃO DESCARTÁVEIS EURODEFIPADS
МНОГОФУНКЦИОНАЛЬНЫЕ ОДНОРАЗОВЫЕ ЭЛЕКТРОДЫ
EURODEFIPADS
®
ΗΛΕΚΤΡΟ∆ΙΑ ΠΟΛΛΑΠΛΩΝ ΛΕΙΤΟΥΡΓΙΩΝ ΜΙΑΣ ΜΟΝΟ ΧΡΗΣΗΣ
EURODEFIPADS
®
MULTIFUNKTIONELLA ELEKTRODER FÖR ENGÅNGSBRUK
EURODEFIPADS
®
VIŠENAMJENSKE ELEKTRODE ZA JEDNOKRATNU UPOTREBU
EURODEFIPADS
®
PL
CS
HU
ELEKTRODY WIELOFUNKCYJNE JEDNORAZOWEGO UŻYTKU
EURODEFIPADS
®
JEDNORÁZOVÉ MULTIFUNKČNÍ ELEKTRODY EURODEFIPADS®
EGYSZERHASZNÁLATOS TÖBBFUNKCIÓS ELEKTRÓDÁK
EURODEFIPADS®
TRUZIONI D’USO
IS
ERATING INSTRUCTION
OP
INSTRUCTIONS D’UTILISATION
BRAUCHSANWEISUNG
GE
GEBRUIKSAANWIJZINGEN
INSTRUCCIONES DE USO
INSTRUÇÕES
РУКОВОДСТВО ПО ЭКСПЛУАТАЦИИ
Ο∆ΗΓΙΕΣ ΧΡΗΣΗΣ
BRUKSANVISNING
UTE ZA UPOTREBU
UP
INSTRUKCJE UŻYTKOWANIA
POKYNY K
SZNÁLATI UTASÍTÁS
HA
POUŽITÍ
Page 3
[1] Ian Jacobs, Kjetil Sunde, et al. “Part 6: Defibrillation. 2010 International Consensus on
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment
Recommendations” Circulation 2010;122:S325-S337
[2] Jerry Nolan et al. “European Resuscitation Council Guidelines for Resuscitation 2010”
Resuscitation Vol. 81, 2010, Editor Jerry Nolan, Bath, UK
[3] A. Luciano et al., "BODY-MASS INDEX REFERENCE CURVES FOR CHILDREN AGED 3-19
YEARS FROM VERONA, ITALY", European journal of clinical nutrition, 51(1), 1997, pp. 6-10
[4] Edward J. Sondik, et al. “2000 CDC Growth Charts for the United States: Methods and
Development” Vital and Health Statistics. Series 11, Number 246: May 2002
[5] John M. Field et al. “2010 American Heart Association Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care” Circulation 2010, 122:S640-S946 Journal
of the American Heart Association Editor Mary Fran Hazinski, RN, MSN
[6] Luis A. Pagan-Carlo, Kirk T. Spencer, et al. “Transthoracic defibrillation: importance of
avoiding electrode placement directly on the female breast” Journal of American College of
Cardiology 1996;27:449-452
[7] Edward A. Panacek, Mark A. Munger et al. “Report of nitropatch explosions complicating
defibrillation” American Journal of Emergency Medidicine 1992;10:128-9
[8] Keith Wrenn “The hazards of defibrillation through nitroglicerin patches” Annals of Emergency
Medicine 1990;19:1327-8
[9] Johannes C. Manegold, Carsten W. Israel et al. “External cardioversion of atrial fibrillation in
patients with implanted pacemaker or cardioverter-defibrillator sistems: a randomized
comparison of monophasic and biphasic shock energy application” European Heart Journal
2007;28:1731-8
3
Page 4
EN
DISPOSABLE MULTIFUNCTION ELECTRODES EURODEFIPADS®
OPERATING INSTRUCTION
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
IMPORTANT
The product is intended for use in non-sterile environment by authorized personnel only.
Before using the product, the user should deeply understand these instructions.
DESCRIPTION
The disposable multifunction electrodes FIAB EURODEFIPADS
®
are constituted by a pair of
adhesive pads provided with gels and direct connection to cables and defibrillators which may be
used in place of the manuals reusable paddles [1].
PACKAGING
Each pair of FIAB disposable multifunction electrodes is packaged in sealed envelopes of opaque
material suitable to protect the gel from light and moisture. Envelopes are included in the carton
sales package along with a copy of the operating instructions.
INDICATIONS
The disposable multifunction electrodes FIAB EURODEFIPADS
®
are indicated for:
• Transthoracic external defibrillation.
• Transthoracic synchronized cardioversion.
• Transthoracic ECG Monitoring.
• Temporary transthoracic cardiac pacing (non-invasive).
FIAB disposable multifunction electrodes allow the user to effectively operate in the treatment of
rhythm disorders related to the above-mentioned applications, without the risk of accidental
electrocution related to the use of normally available reusable paddles.
CONTRAINDICATIONS
• FIAB disposable multifunction electrodes for adults are generally contraindicated in patients
younger than 8 years old [2] (weighing less than 25kg [3][4])), but can be used if the size of the
chest allow it, taking care that one pad do not come in contact with the other one. Follow the
operating instructions of the defibrillator for energy to be delivered.
• The use of FIAB disposable multifunction electrodes in versions for adult or adult/paediatric is
generally contraindicated in patients aged less than 12 months (weighing less than 10kg).
• The use of FIAB pediatric disposable multifunction electrodes is generally contraindicated in
patients older than 8 years old [2] (weighing more than 25kg [3][4]);
• Do not apply on skin that shows signs of irritation or injury.
MODE OF USE
External Defibrillation and synchr
onized cardioversion: the FIAB disposable multifunction
electrodes are able to transfer to the patient the electrical energy supplied by the defibrillator up to
a maximum value of 360J in the adult version [1], of 300J for adult/paediatric unic version and of
100J in the paediatric version [5].
The depolarization of the critical mass of the myocardium, which is essential for the success of the
therapy, is only possible if it is crossed by a current of appropriate intensity: the active surface of
the electrodes is optimized for this purpose. It is therefore appropriate, in addition to a targeted
selection of the positioning sites, to apply the adhesive pads in such a way that their contact
surface with the skin is maximum. The choice of power to supply is at the discretion of the
operator.
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In paediatric applications the Guidelines for cardiopulmonary resuscitation recommend a supply of
energy of 2-4J / kg; the recommended starting level is of 2 J / kg and it is preferable not to exceed
100J in order to avoid burns [5].
ATTENTION FIAB disposable multifunction electrodes can withstand up to 50 defibrillation
shocks.
ATTENTION Do not supply a shock with manual metal paddle above the disposable electrode
pads or ECG electrodes.
Non-invasive transthoracic pacing: FIAB disposable multifunction electrodes can be used for noninvasive transthoracic pacing. To minimize the threshold of pacing it is appropriate to apply the
adhesive plates in the manner described above. It is also necessary to have a good understanding
of the equipment you want to use and follow the manufacturer's instructions.
ATTENTION It is good practice to replace FIAB disposable multifunction electrodes after 8 hours,
checking, in case of prolonged pacing (greater than 30 minutes), the skin of the patient for signs
of irritation.
ATTENTION Replace FIAB disposable multifunction electrodes after 30 minutes if the supplied
pulses are monophasic and longer than 20ms.
ECG monitoring: FIAB disposable multifunction electrodes can also be used for ECG monitoring.
ATTENTION If the tracing is not sufficiently clear, use an ECG patient cable, if it is present, and a
separate set of ECG electrodes.
MODE OF APPLICATION
• The multifunction electrodes can be applied to the patient even in the mere suspicion that a
severe arrhythmic disease may develop.
• The points where it is possible to apply the adhesive electrodes are listed in “PLACEMENT AND
POLARITY”.
• Uncover the chest and prepare the skin. Remove excessive hair [1]. Slightly abrade the skin
surface to reduce the contact impedance. Avoid applying the adhesive pad on the nipple or
breast tissue [6].
• Remove any residue (dirty, greasy and debris), using non-flammable cleaners. Finally, make sure
the application sites are clean and dry.
• Open the package and remove multifunction electrodes.
• Gently remove the protective liner, starting from the tab to expose the adhesive and conduction
areas.
• In case of multifunctional electrodes with clips remove the protective support.
• Apply the adhesive pads one-to-one starting with one side and pressing progressively over the
entire surface to avoid the formation of air bubbles and ensure complete adhesion to the skin.
Keep the adhesive pads well separated one from the other and be careful not to overlap them
with other objects (ECG electrodes, cables, transdermal patches, clothing etc.) [7][8].
• Do not reposition the adhesive pads once applied. If the position must be changed, remove and
replace with new multifunction electrodes.
• To remove the adhesive plate without irritating the patient's skin, lift an edge and gently pull back.
Hold at the same time the skin with the other hand.
• For multifunctional electrodes without clip: connect the electrodes to the defibrillator or the
adapter cable by following the instructions for use of the defibrillator.
• For multifunctional electrodes with clips: connect the clip to the cable of the defibrillator for the
correct polarity, observing the instructions for use of the defibrillator.
• For on demand pacing, separately connect ECG monitoring electrodes.
POSITIONING AND POLARITY
The international guidelines indicate various placements as equally effective for the treatment of
atrial or ventricular arrhythmias [1][5].
The following figures show the application s
manufacturers of defibrillators. Choose the most appropriate points of application of the therapy
according to manufacturer's instructions for use of the defibrillator to be used.
ites commonly used and recommended by most
5
Page 6
For ease of placement and for training purposes, the anterior-lateral side (Fig.1) is preferred for
arrhythmias defibrillation and cardioversion; the anterior-posterior side (Fig.2) is more common in
hemodynamics and in transthoracic pacing and recommended in case of use of electrodes for
adults on pediatric patients.
Fig.1
• Defibrillation
• Cardioversion
• Pacing
• Monitoring (it
provides a track
Lead II)
Fig.2
• Pacing
• Monitoring
• Defibrillation
• Cardioversion
To maintain the proper signal polarity, apply the electrode pads in the indicated positions (the apex
is identified by the symbol of the heart). However note that for the purpose of the therapy, it is not
relevant which electrode pad (apex / sternum) is placed in one of the two positions [2].
Regarding the polarity of the electrodes in unique version adult/pediatric, follow the directions on
the labels of the electrode pad (according to the instructions of the manufacturer of the defibrillator
to be used).
SIDE EFFECTS
• Plate adhesive may cause light cutaneous irritation.
• The prolonged transthoracic stimulation or the repeated administration of defibrillation shock may
cause more or less noticeable skin reddenings according to the supplied energy.
• A lack in adhesion and/or air presence under the electrode may cause burnings.
PRECAUTIONS AND WARNINGS
• Use the product only on defibrillators brands indicated on the labels.
• Check that the product is compatible with the specific model of defibrillator intended to be used.
• Read the instructions for use of the defibrillator, with particular attention on the placement of
multifunction electrodes, their polarity and the power to be supplied.
• In paediatrics and for some models of automatic defibrillators the use of specific reducing power
devices or the adoption of special precautions may be required. Always pay a special attention to
energy levels set on the defibrillator and that can be delivered to the paediatric patient (see
section "MODE OF USE").
ATTENTION
Do not use paediatric multifunction electrodes marked with the symbol shown
beside with automatic defibrillators.
Paediatric multifunction electrodes marked with the symbol shown beside are
indicated for use with automatic defibrillators.
• The electrode choice should be based on the evaluation of chest size and weight of the patient.
Paediatric electrodes used beyond the specified energy limit may cause also major skin burns; on
the contrary the extended active surface of adult electrodes may jeopardize the therapy when
used for pediatric treatment.
• After an extended period of transthoracic pacing the ability to detect the evoked ECG signal can
be reduced. In this case it is necessary to provide for the collection of the evoked signal by a
separate set of ECG electrodes.
6
Page 7
• Replace the multifunction electrodes after 24 hours from their application on the patient's skin.
• Check the expiration date on the package. Do not use after this date.
• Do not use multifunction electrodes if removed from the envelope for more than 24 hours. The
adhesive pads are to be applied within 30 minutes after removal of the protective coating.
• Check that the packaging is intact: do not use the product otherwise.
• Do not use the multifunction electrodes if the gel is removed from the support or if it is ripped, torn
or dry. Any discoloration localized on gel or on conductive foil does not affect the functionality of
the product.
• Do not use the multifunction electrodes if during removal of the protective coating the product is
damaged (eg. the insulating coating of the contact has detached or there are tears in the foam
support and/or in the electrode).
• Do not bend, do not cut and do not squash the adhesive pads.
• Do not use the multifunction electrodes if the connector, the cable or the clips appear to be
damaged.
• Check on the operating instructions of the defibrillator at which safety distances the devices
(surgeon's electric knife, RF ablators, diathermy equipment, mobile phones, etc.) that emit strong
electromagnetic interferences must be placed. Position the defibrillator / electrode system at a
distance of at least one and a half times the recommended separation distances.
• To prevent accidental damage from electric shock, ensure that during discharge operators are not
in contact with the electrode pads, with the patient, or with conductive parts close to the patient.
• When defibrillators are used near oxygen sources or other flammable gases, use extreme care to
avoid risk of fire or explosion.
• The product neither is sterile nor can be sterilized.
• The product is disposable. For use on a single patient. Discard after use.
POTENTIAL COMPLICATIONS
There are no complications related to the use of multifunction electrodes.
ATTENTION: The defibrillator discharge may cause irregularities in the operation of an implanted
pacemaker/defibrillator [1]; apply the multifunction electrodes at a distance of at least 8cm [9].
After defibrillator discharge check its operation.
ATTENTION: If the chosen energy level is insufficient the success of therapy may be
jeopardizing. On the contrary, higher levels may modify the enzyme structure without actual
evidence of myocardial damage.
PRODUCT LIFE AND STORAGE
Check the expiration date printed on the package.
The product should be stored in its original packaging in rooms with environment conditions
temperature and relative humidity, specified on the label. The storage at extreme temperatures
must be limited to short periods (24 hours at -30°C or +65°C). Prolonged storage at extreme
temperatures can shorten the life of the product.
ATTENTION: The overlap of weights on the packaging could damage the product.
DISPOSAL
Refuses deriving from health structures must be disposed in according to the regulation in force.
WARRANTY AND LIMITATIONS
FIAB S.p.A. guarantees that the product complies with Directive 93/42/EEC. No responsibility may
be ascribed to the Manufacturer who shall not be held liable for medical costs, direct or indirect
damage due to lacking function or malfunction of the above product, when used differently from the
instruction for use. We recommend to report opportunely any malfunction or defect of the product
to FIAB Quality Assurance Service.
of
7
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Conformità
Europea
European
Conformity
Conformité
Européenne
CE
Prüfzeichen
Europese
conformiteit
Conformidad
Europea
Conformidade
Europeia
Prodotto
da
Manufactured
by
Produit par
Erzeugt von Katalognummer Postenummer Stück/ Packung
Geproduceerd
door
Fabricado
por
Fabricado
por
Numero di
Catalogo
Catalogue
Number
Numéro de
catalogue
Catalogus-
nummer
Número de
catálogo
Número de
Catálogo
Numero di
Lotto
Batch
number
Numéro de
Lot
Partijnummer
Número de
Loto
Número de
Grupo
Numero
pezzi per
confezione
Pcs. per
box/pack
Numéro de
pièce par
emballage
Aantal artikels
per verpakking
Piezas por
bolsa o
paquete
Unidades por
embalagem
Data di
Produzione
Production
date
Date de
production
Erzeugungsda
tum
Productiedatum
Fecha de
producción
Data de
Fabrico
Usare entro il
Use before
Utiliser
avant le
Verwendbar
bis
Te gebruiken
binnen
Usar antes
de
Usar antes
de
Limiti
temperatura
Temperature
limits
Limites de
température
Temperaturbegrenzu
ngen
Temperatuur
limieten
Límites de
temperatura
Limites de
temperatura
Temperatura
operativa
Operating
temperature limits
Température de
fonctionnement
Betriebstemperat
ur
Temperatuur
limieten
Limites de
temperatura de
funcionamiento
Limites da
temperatura de
funcionamento
Соответствие
нормам ЕС.
Ευρωπαική
συµµόρφωση.
Överensstämm
er
med
EG-direktiven
Usklađenost s
EU zahtjevima
Zgodność
Europejska
Evropská
shoda
Az (EU)
rendeletnek
való megfelelés
Изготовитель
Κατασκευασµέν
ο από
Tillverkad av Artikelnummer Satsnummer
Proizvođač Kataloški broj Broj serije
Wyprodukowan
y przez
Vyrobeno v Katalogové číslo Šarže
Gyártó
Номер по
каталогу
Αριθµός
καταλόγου
Numer
katalogu
Katalógus
száma
Номер
партии/изделия
Αριθµός
λαχειοφόρου
αγοράς
Numer
partii
Batch kód
Кол-во в
коробке/упаковке
Τεµάχια ανά
κουτί/πακέτο
Antal per
låda/förpackning
Komada u
kutiji/pakiranju
Liczba
sztuk w
opakowaniu
Kusů v
krabici/balení
Mennyisége
darabok
Дата
изготовления
Ηµεροµηνία
παραγωγής
Tillverkningsdag
Datum
proizvodnje
Data
Produkcji
Datum výroby Použitelné do Meze teploty
Gyártás dátuma
Использоват
ь до
Να χρησ/θεί
πριν από
Används
innan
Rok
valjanosti
Używać w
terminie do
használata
által
Ограничения по
температуре
Ορια θερµοκρασίας
Temperatur-
gränser
Granice temperature
Wartości graniczne
temperatury
Hőmérséklet
korlátozás
Пределы
рабочей
температуры
Όρια
θερµοκρασίας
λειτουργίας
Temperaturgräns
er för användning
Granice radne
temperature
Temperatura
operacyjna
Meze provozní
teploty
Üzemi
hőmérséklet
8
Page 9
Limiti di
A
g
A
Umidità
Humidity
limits
Tenere al
riparo dalla
luce solare
Keep away
from sun
light
Teme
l'umidità
Keep
away from
humidity
ttenzione
leggere
attentamente la
documentazione
alle
ata
Warning: read
the enclosed
documentation
Consultare le
istruzioni d'uso
Consult instructions
for use
Non
riutilizzare
Do not
reuse
Non contiene
LATTICE
di gomma
naturale
Latex free
Compatibile con
Corpuls3 (Defib-Unit con
pad riusabili)
Compatible with
Corpuls3 (Defib-Unit with
reusable pads)
Non usare con Corpuls3 con
Defib-Unit SLIM
Do not use with Corpuls3 with
Defib-Unit SLIM
Limites
d'humidité
Feuchtigkeits-
begrenzungen
Vochtigheidsgre
ns
Limites de
humedad
Limites de
Humidade
Ограничения по
влажности
Επίπεδα
Υγρασίας
Protéger des
rayons
du soleil
Vor Sonne
schützen
Tegen
zonnelicht
beschermen
Mantener
lejos de la
luz solar
Manter
protegido da
luz do sol
Оберегать от
солнечных
лучей
Μακριά από
φως
Craint
l'humidité
Vor
Feuchtigkeit
schützen
Niet
bestand
tegen
vochtigheid
Mantener
lejos de la
humedad
Teme a
humidade
Оберегать от
влаги
Μακριά από
υγρασία
Attention lire
attentivement la
documentation ci-
jointe
Warnzeichen:
lesen Sie die
Beschreibung
Let op, lees
zorgvuldig de
bijgesloten
documentatie
Alerta: lea la
documentación
adjunta
Atenção, ler
atentamente a
documentação
incluída
Внимание:
прочитайте
прилагаемую
документацию
Προειδοποίηση
Consulter les
instructions
Gebrauchsanweisu
ng lesen
Lees eerst de
instructies
Consulte las
instrucciones de
uso
Consultar
instruções de
utilização
Обратитесь к
инструкции по
применению
Συµβουλευτείτε τις
οδηγίες χρήσης
Ne contient
Ne pas
réutiliser
Einmalgebrauch Latexfrei
Niet her te
gebruiken
No
reutilizar
Não
reutilizar
Не использовать
повторно
Να µην
ξαναχρησιµοποιηθ
εί
pas de latex
de
caoutchouc
naturel
Bevat geen
natuurrubber
Libre de
látex
Não contém
látex de
borracha
natural
Не содержит
латекса
Χωρίς λάτεξ
Compatible avec
Corpuls3 (Defib-Unit
avec pad réutilisables)
Kompatibel mit Corpuls3
(Defib-Unit mit
wiederverwendbaren
Pads)
Compatibel met
Corpuls3 (Defib-Unit met
hergebruikbaar pad)
Compatible con
Corpuls3 (Defib-Unit con
pad reusables)
Compatível com
Corpuls3 (Defib-Unit com
placas reutilizáveis)
Совместим с Corpuls3
(Defib-Unit с
многоразовыми
пластинами)
Συµβατό µε Corpuls3
(Defib-Unit µε pad
επαναχρησιµοποιήσιµα)
Ne pas utiliser avec Corpuls3
avec Defib-Unit SLIM
Nicht mit Corpuls3 mit Defib-
Unit SLIM verwenden
Niet gebruiken met Corpuls3
met Defib-Unit SLIM
No usar con Corpuls3 con
Defib-Unit SLIM
Não usar com Corpuls3 com
Defib-Unit SLIM
Не использовать с Corpuls3 с
Defib-Unit SLIM
∆ε χρησιµοποιείται µε
Corpuls3 µε Defib-Unit SLIM
Fuktighetsgrän
ser
Granice
vlažnosti
Wartości
graniczne
wilgotności
Meze vlhkosti
páratartalom
korlátozás
Skyddas
mot solljus
Držati podalje
od izvora
sunčevog
svjetla
Przechowywać
z dala od
światła
słonecznego
Uchovávejte
mimo sluneční
záření
Tartsa távol a
napfénytől
Skyddas
mot väta
Držati na
suhom mjestu
Chronić
przed wilgocią
Uchovávejte v
suchu
Tartsa
szárazon
Varning: läs
den bifogade
bruksanvisningen
Upozorenje:prouči
te priloženu
dokumentaciju
Uwaga dokładnie
przeczytać
załączoną
dokumentację
Varování: čtěte
přiloženou
dokumentaci
Vigyázat,
konzultáljon kísérő
dokumentumokat
Läs
bruksanvisningen
Pročitajte upute za
upotrebu
Zapoznać się z
instrukcją
użytkowania
Věnujte pozornost
návodu k použití
Consult használati
utasítás
9
Endast för
engångsbruk
Za jednokratnu
upotrebu
Nie
używać ponownie
Nepoužívejte
opakovaně
Ne használja újra
Latexfri
Ne sadrži
latex
Nie zawiera
LATEKSU
z gumy
naturalnej
Bez latexu
Nem
tartalmaz
természetes
gumi latex
Kompatibel med
Corpuls3 (Defib-enhet
med återanvändbar
dyna)
Kompatibilan sa
Corpuls3 (Defib-Unit sa
papučicom za višestruku
primjenu)
Kompatybilny z Corpuls3
(Defib-Unit z
podkładkami
wielokrotnego użytku)
Kompatibilní s Corpuls3
(Defibrilační jednotka s
opakovaně použitelnými
elektrodami)
Kompatibilis a Corpuls3-
zal (Defib-egység
újrafelhasználható
párnákkal)
nvänd inte med Corpuls3 med
Defib-enhet SLIM
Ne upotrebljavati sa Corpuls3
sa Defib-Unit SLIM
Nie używać z zastosowaniem
Corpuls3 z Defib-Unit SLIM
Nepoužívejte s Corpuls3 a
defibrilační jednotkou SLIM
Ne használja a Corpuls3-szal
Defib-Unit SLIM készülékkel
Page 10
SpA
Via Costoli, 4 – 50039 - Vicchio
(Florence, ITALY) - www.fiab.it
52502797IU9C / 2020-10
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