IT CIRCUITI RESPIRATORI E ACCESSORI
Istruzioni per l’uso
EN BREATHING CIRCUITS AND ACCESSORIES
Instructions for use
DE BEATMUNGSSCHLÄUCHE UND ZUBEHÖR
Gebrauchsanweisung
FR CIRCUITS RESPIRATOIRES ET ACCESSOIRES
Mode d’emploi
EL ΑΝΑΠΝΕΥΣΤΙΚΑΚΥΚΛΏΜΑΤΑΚΑΙΒΟΗΘΗΤΙΚΑ
ΕΞΑΡΤΗΜΑΤΑ
Oδηγίεςχρήσης
ES CIRCUITOS DE RESPIRACIÓN Y ACCESORIOS
Instrucciones de uso
HU LÉGZŐKÖRÖKÉSKIEGÉSZÍTŐI
Használati utasításokat
NL BEADEMINGSCIRCUITS EN ACCESSOIRES
Gebruiksaanwijzing
PL OBWODYWENTYLUJĄCEIAKCESORIA
Instrukcjaużycia
PT CIRCUITOS DE RESPIRAÇÃO E ACESSÓRIOS
Instruções de utilização
RO CIRCUITERESPIRATORIIŞIACCESORII
Instrucţiuniledeutilizare
SV ANDNINGSSYSTEM OCH TILLBEHÖR
Bruksanvisning
CS DÝCHACÍOKRUHYAPŘÍSLUŠENSTVÍ
Návodkpoužití
2
EN
INTENDED USE
Breathing circuits and related accessories (Mount catheter,
reservoir bag, gas monitoring line, face mask, CPAP mask,
PEEP valve), single use, for anaesthetic apparatus and lung
ventilators, to conduct gases and/or vapour from the appa-
ratus (V) to the patient (P). DEAS breathing circuits are man-
ufactured in compliance with EN ISO 5367 standard. This
device is intended for short term use (less than 30 days)
in accordance with Directive 93/42/EEC and subsequent
amendments.
TECHNICAL INFORMATION
Recommended maximum operating pressure: < 8,826 kPa (90 cmH2O)
Patient category Intended delivered
volume ml
Internal diameter
mm
Increase in
pressure
hPa/l/min
(cmH2O/l/ min)
Atow
l/min
Compliance limit
ml/hPa
At pressure
hPa
Adult ≥300 19 < 0.06 30 < 5.0 60 ± 3
Paediatric 50 < 300 15 < 0.12 15 < 4.0 60 ± 3
Neonatal ≤50 11 < 0.74 2.5 < 1.5 60 ± 3
DIRECTIONS FOR USE
Carefullyreadtheproductlabelandthisleaetbeforeusing
the device. Open the packaging, checking that it is complete
and free from foreign bodies. Do not use the device if the
package is damaged. Any damage or opening in the pack-
age may affect sterility and/or device performance. In this
case do not use the device concerned.
BREATHING CIRCUIT
Connect the breathing circuit’s components as shown on the
graphical representation. Make sure that the connections
are properly secured. Pay special attention to the instruc-
tions provided below:
- if the breathing circuit contains a water trap to collect conden-
sation (Fig. C point 7), this must be kept vertical and in a posi-
tionwhichallowstheuidcollectinginsidethetubestodrain;
checkthelevelofllingfrequentlyandemptyitwhenneces-
sary. Then make sure that the water trap is properly closed;
- the monitoring ports (Fig. . B, C, D, E, F point 4) allow the
respiratory gases and/ or airway pressure to be checked and
should remain closed when not in use;
- if there is a gas monitoring line (Fig. D, E, F point 5) in the
breathing circuit, this must be connected to the control out-
let positioned on the ventilator (V). Regularly make sure that
large amounts of condensation are not forminginside as this
can stop the ventilator (V) from functioning properly;
- if the device has an expiratory port (Fig. D, E, F point 6) this
must not be sealed or obstructed. If it is obstructed this may
cause serious damage to the patient or even his death;
- if there are unidirectional valves in the device, check that they
areworkingproperlyandthedirectionofowpriortouse;
- if the circuit contains a pressure-limiting valve (Fig. E point
8), make sure that it is working properly before using it with
a patient. If it needs to be deactivated, use the appropriate
stop switch;
- the breathing circuits represented in Fig. D, E must only be
installed on models of ventilator (V) as indicated on the la-
bel. Installing the breathing circuit on a different model of
ventilator can prevent the system from working correctly.
Should the user want to install the circuit on ventilator mod-
elsnotindicatedonthelabel,theusershouldrstcontact
DEAS or its local representative to verify the compatibility of
the circuit to be installed with the relevant ventilator model.
ACCESSORIES
Catheter Mount: The Catheter Mount (Fig. A, B, C, D point 2)
isaexibleadaptorforjoiningorconnectingthebreathing
system to a tracheal or tracheostomy tube connector or to a
face mask. The patient side connector can be straight or at
an angle, with or without a cap. Connect the catheter Mount
to the breathing circuit as shown in the illustration. Remove
the cap (Fig. A, B, C, D point 3) only for the time strictly neces-
sary for carrying out tracheal aspiration or a bronchoscopy.
Opening the cap causes a loss of pressure in the breathing
system and the impossibility of ventilating the patient Rou-
tinely check the patency of the device. Using this device
causes the increase of the dead space.
Reservoir bag: The reservoir bag (Fig. A point 10) is a device
for inhaled anaesthesia induction or for ventilatory support. It is
connected to the anaesthesia machine or the manual breathing
unit. Check that it is functioning properly before using on the
patient. Do not use the device in case of malfunction.
Gas monitoring line: The gas monitoring line (Fig. D, E, F
point 5) is a device for checking respiratory gases and/or
airway pressure. It is connected to the control port of the
ventilator or monitoring apparatus and to the monitoring
port on the breathing circuit. Regularly make sure that large
amounts of condensation are not forming inside it as this
can stop the monitoring apparatus from functioning proper-
ly. Regularly make sure that large amounts of condensation
are not forminginside as this can stop the ventilator (V) from
functioning properly.
Face mask: The face mask (Fig. A point 1) is a device for
inhaled anaesthesia induction or for ventilatory support. It is
suppliedwithapre-inatedorinatablepad.Theinationof
thepadcanbeadjustedbyinjectingorremovingairthrough
a syringe which must be connected to the appropriate valve;
disconnect the syringe when the adjustment is complete
and check that the system is sealed. Make sure that the ap-
paratus (V) or the breathing circuit has an adequate system
for CO2 elimination. The mask must be removed if the pa-
tient suffers claustrophobia, skin irritation or retching. Using
this device causes the increase of the dead space.
3
CPAP mask: The CPAP face mask (Fig. F point 11) is a de-
vice for positive airway pressure mechanical ventilation. It is
connected to the patient’s face through a mask. It is supplied
with two connections: inspiratory, for connecting the circuit or
the ventilation tube, and expiratory for connecting the PEEP
valve. Both connections have unidirectional valves. It is also
equipped with a port for monitoring pressure or EtCO2. At the
edgeofthemaskisaninatablepad.Theinationofthepad
canbeadjustedbyinjectingorremovingairthroughasyringe
which must be connected to the appropriate valve; disconnect
thesyringewhentheadjustmentiscompleteandcheckthat
the system is sealed. Check that it is functioning properly
before using on the patient. Do not use the device in case of
malfunction. The mask must be removed if the patient suffers
claustrophobia, skin irritation or retching. Using this device
causes the increase of the dead space.
PEEP valve: The PEEP valve (Fig. F point 9) is a device for
maintaining positive end-expiratory pressure. It is connected
to the expiratory connection of the CPAP face mask (Fig. F
point 6) or to that of the expiratory valve (Fig. D point 6). It
canbexedoradjustable.Checkthatitisfunctioningprop-
erly before using on the patient. Do not use the device in
caseofmalfunction.SelectoradjustthePEEPappropriate-
ly. Regularly check the level of positive expiratory pressure
set using an adequate monitoring system. Once the breath-
ing system is connected to the apparatus, check the seal
in pressure using a test lung following the manufacturer’s
instructions. Make sure that there are no leaks or blockages.
Then connect the patient and monitor him throughout the
ventilation process. During use, regularly check that all the
connections are properly secured and that there are no leaks
or blockages. For all the alarms issued by the connected
apparatus make sure that the connection is adequate and
check the patient’s condition and the adequacy of the con-
nection each time there is a signal.
WARNINGS
Thisdeviceshouldbeused onlybyqualied and/ortrained
personnel. Before using the device, ensure that an appropriate
pressure-limiting device is correctly installed in the breathing
system and is functioning. Excessive pressures can cause
barotrauma! Ensure that the breathing circuit is adequately
supported and positioned by a supporting arm. If the circuit
is insufficiently supported or wrongly positioned, this may
cause tensile stress to the circuit, unexpected disconnections
orinhalationofanycondensationproducedbythehumidier
and collected in the bend in the circuit. Using an inadequate
supporting arm can damage the breathing circuit. Regular-
ly check that condensation is not forming inside the device
asthiscouldcauseanincreaseinresistancetoow,trigger
the ventilator’s alarm or cause incorrect measurements of
respiratory signs. Do not stretch the device, allow it to form
kinks or other types of mechanical stress. When connecting
and disconnecting the breathing circuit, avoid compressing or
pulling on the tube to prevent dam- age that could cause leaks
in the breathing system, compromising ventilation. Operating
temperatures above 43 °C can damage the breathing circuit.
Non-conductiveandinammableproductnotsuitableforuse
withinammable(non-AP/APG)anaestheticgases,electrosur-
gery or lasers. Use of the device in these situations can lead to
theriskofre.Donotuseafterlapseoftheuse-bydate.
DURATION OF USE
Single-use device to be used on a single patient. Reuse may
cause cross- infections. DO NOT soak, wash, sterilize or
reuse this product. Avoid contact with chemical substanc-
es,cleaning products or sanitisers. These substances may
damage the device and cause the product to malfunction.
Duration of use of the device on the same patient must be
determined by the personnel responsible and in accordance
with proven procedures for controlling infection. Prolonged
use of the device may alter its mechanical safety character-
istics Replace the device immediately in case of leakage,
occlusion, and if connections become unsafe.
STORAGE AND DISPOSAL
The device should be stored respecting the instructions giv-
en by the symbols on the packaging. After use, the device
must be treated and / or disposed of as hazardous medical
waste according to local regulations in force.
RESPONSIBILITY
DEAS devices guarantee top quality and products which are
in compliance with the standard in force for safe use.
DEAS will not be responsible for any consequences resulting
from incorrect choice of model or size or use other than that
indicated. If you notice that the device’s features or perfor-
mance have deteriorated or are malfunctioning and/or there
are serious problems, inform DEAS straight away.
If this happens, we will need you to send the device con-
cerned along with appropriate photos, placed in the original
packaging so the batch can be traced.
DIRECT TECHNICAL ASSISTANCE
Ifyouareunsureabout interpreting this instruction leaet
or if you would like any additional technical information,
contact the DEAS customer services directly at the address
indicated overleaf.
4
IT EN DE FR
LEGENDA DEI SIMBOLI
SUL CONFEZIONAMEN-
TO
KEYTOSYMBOLS
ONPACKAGING
ERKLÄRUNGDER
SYMBOLE AUF DER
VERPACKUNG
SIGNIFICATION DES
SYMBOLES SUR
L’EMBALLAGE
Codice Re-order number Katalog-Nummer Numero de référence
Monouso Single use Einwegprodukt A usage unique
Lotto Lot number Chargennumwmer Numéro de lot
Data di scadenza Use by Mindesthaltbarkeits-
datum
Date de péremption
Misura Size Größe Taille
Sterilizzato ad ETO Sterilised by ETO ETO sterilisiert Stérilisé à l’ETO
Non sterile Non-sterile Unsteril Non stérile
Senza ftalati Phthalates free Phthalaten frei Sans phtalates
Senza lattice Latex free Latex frei Sans latex
Aprire qui Open here Hier öffnen Ouvrir ici
Consultare le istruzioni
per l'uso
See instructions for use Beachten Sie die Geb-
rauchsinformation
Lire le mode d'emploi
Quantità Quantity Menge Quantité
Teme l'umidità Keepdry Trocken aufbewahren Craint l'humidité
Teme il calore Keepcool Kühlaufbewahren Craint la chaleur
Non usare ganci Do not use hooks KeineHakenverwenden Ne pas utiliser de
crochets
Non utilizzare lame Do not use blades KeineMesser/Scheren
verwenden
Ne pas utiliser de lames
Limiti di temperatura Temperature limitations Zulässiger Temperaturb-
ereich
Limites de température
Non utilizzare se
la confezione è
danneggiata
Do not use if package is
damaged
Nicht verwenden,
wenn die Verpackung
beschädigt ist
Ne pas utiliser si
l'emballage est
endommagé
Produttore Manufacturer Hersteller Producteur
DEAS S.r.l.
via dell’Industria, 49
48014 · Castel Bolognese (RA) · Italy
Tel. +39 0546 656845 · Fax +39 0546 54706
[email protected] · www.deasnet.it
Made in Italy
© DEAS S.r.l. 09506-3 · 2022-03
IT
CONFIGURAZIONI TIPICHE
Peraltrecongurazioni,contattareDEASoisuoi
rappresentanti locali.
EN
TYPICAL CONFIGURATIONS
Forothercongurations,pleasecontactDEASoritslocal
representatives.
DE
TYPISCHE KONFIGURATIONEN
FürweitereKongurationenwendenSiesichanDEAS
oder den nächstgelegenen Vertreter.
FR
CONFIGURATIONS HABITUELLES
Pourlesautrescongurations,contactezDEASouses
représentants locaux.
EL
ΤΥΠΙΚΕΣ ΔΙΑΜΟΡΦΩΣΕΙΣ
Γιαάλλεςδιαμορφώσεις,επικοινωνήστεμετηνDEASή
τουςτοπικούςαντιπροσώπουςτης.
ES
CONFIGURACIONES TÍPICAS
Parainformaciónsobreotrasconguraciones,contacte
con DEAS o con sus representantes locales.
HU
TIPIKUS KONFIGURÁCIÓ
TovábbikongurációkértlépjenkapcsolatbaaDEAS-al
vagyhelyiképviselőjével.
NL
STANDAARD CONFIGURATIES
NeemvoorandereconguratiescontactopmetDEASof
meteenplaatselijkevertegenwoordigervanditbedrijf.
NO
TYPISKE KONFIGURASJONER
ForandrekongurasjonermådukontakteDEASellerden
lokale representanten.
PL
TYPOWE KONFIGURACJE
WprzypadkuinnychkonguracjiskontaktowaćsięzDEAS
lub lokalnymi przedstawicielami.
PT
CONFIGURAÇÕES TÍPICAS
Paraoutrascongurações,porfavorcontacteDEASouos
seus representantes locais.
RO
CONFIGURAȚII TIPICE
Pentrualtecongurații,vărugămsăluațilegăturacuDEAS
saureprezentanțiisăilocali.
SV
TYPISKA KONFIGURATIONER
KontaktaDEASellerdesslokalarepresentanterförandra
kongurationer.
CS
TYPICKÁ KONFIGURACE
Projinékonguracelaskavěkontaktujtevýrobce-spo-
lečnostDEAS,nebomístníhoautorizovanéhozástupce.
FIG. A
1
FIG. B
FIG. C
FIG. D
FIG. E
FIG. F
8
-
1
-
2
-
3
-
4
-
5
in altre lingue
- English: Gima 34035 Owner's manual
- română: Gima 34035 Manualul proprietarului
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