Ambu AuraOnce™ Disposable Laryngeal Mask Instrucțiuni de utilizare

Tip
Instrucțiuni de utilizare
For use by medical professionals trained
in airway management only.
INSTRUCTIONS
FOR USE
Ambu® AuraOnce
Single Use Laryngeal Mask – Sterile.
2
Symbol
Indication
CN
en Medical Device MR safe Sterilized using
irradiation
Single sterile
barrier system
Do not use if
the product
sterilization barrier
or its packaging is
damaged
Country of
manufacturer
UK Conformity
Assessed
UK Responsible
Person
Importer
(For products
imported into
Great Britain only)
bg 


  
-



 
 
 
 ,
 -
 
  
 
 
 

 
 


 
 


(  -
,  
)
cs Zdravotnic
prostředek
MR bezpečný Sterilizováno
zářením
Systém jedné
sterilní bariéry
Prostředek
nepoužívejte,
pokud došlo k
narušení sterilní
bariéry nebo
k poškození obalu
Země výrobce Posouzení shody
s předpisy Velké
Británie
Odpovědná
osoba ve Velké
Británii
Dovozce
(Pouze pro
produkty dováže
do Velké Británie)
da medicinsk
udstyr
MR-sikker Strålesteriliseret
Enkelt sterilt
barrieresystem
Produktet må ikke
anvendes, hvis
dets sterile barriere
eller emballagen er
beskadiget
Producentland Den britiske
overensstemmel-
sesvurderings-
mærkning
Ansvarshavende
iUK
Importør
(Kun for produkter
importeret til
Storbritannien)
3
Symbol
Indication
CN
de Medizinprodukt MR-sicher Mit Bestrahlung
sterilisiert
Einzel-
Sterilbarrieresystem
Verwenden Sie
das Produkt
nicht, wenn die
Sterilbarriere oder
die Verpackung
beschädigt ist
Produktions-
land
Konformität für
das Vereinigte
Königreich
geprüft
Verantwortliche
Person im
Vereinigten
Königreich
Importeur
(Nur für nach
Großbritannien
importierte
Produkte)
el Ιατρο-
τεχνολογικό
προϊόν
Ασφαλέ για
MR
Αποστειρωένο ε
χρήση ακτινοβολία
Ενιαίο σύστηα
φραγού
αποστείρωση
Μην το χρησιοποι-
ήσετε εάν ο φραγ-
ό αποστείρωση
του προϊόντο ή η
συσκευασία του
έχει καταστραφεί
Χώρα
κατασκευαστή
Με πιστοποίηση
συόρφωση
ΗΒ
Αρόδιο
πρόσωπο
Ηνωένου
Βασιλείου
Εισαγωγέα
(Μόνο για προϊόντα
που εισάγονται στη
Μεγάλη Βρετανία)
es Producto
sanitario
Compatible
conRM
Esterilizado
mediante
irradiación
Sistema de barrera
estéril simple
No lo utilice si la
barrera de esterili-
zación del producto
osu embalaje están
dañados
País de origen
del fabricante
Conformidad
evaluada del
Reino Unido
Persona
responsable en
el Reino Unido
Importador
(Únicamente
para productos
importados
a Gran Bretaña)
et Meditsiiniseade Sobib MRT-
seadmetega
kasutamiseks
Steriliseeritud
kiirgusega
Ühekordne steriilne
barjäärisüsteem
Ärge kasutage
toodet, kui selle
sterilisatsioonibar-
jäär või pakend on
kahjustunud
Tootja riik Ühendkuningriigi
vastavus-
hinnanguga
UK vastutav isik Importija
(Ainult
Suurbritanniasse
imporditud
toodetele)
4
Symbol
Indication
CN
fi Lääkinnällinen
laite
MRI-
turvallinen
Steriloitu
säteilyttämällä
Yksinkertainen ste-
riili sulkujärjestelmä
Älä käytä, jos
tuot-
teen sterilointisuoja
tai sen pakkaus on
vaurioitunut
Valmistusmaa UKCA-merkintä UK
vastuuhenkilö
Maahantuoja
(Koskee vain
Iso-Britanniaan
tuotavia tuotteita)
fr Dispositif
médical
Compatible
avec l’IRM
Stérilisation
par irradiation
Système de barrière
stérile simple
Ne pas utiliser
si la barrière de
stérilisation ou
l’emballage est
endommagé(e).
Pays du
fabricant
Marquage UKCA Responsable
Royaume-Uni
Importateur
(Pour les produits
importés en
Grande-
Bretagne
uniquement)
hr Medicinski
uređaj
Sigurno za
upotrebu uz
MR
Sterilizirano
zračenjem
Sustav jednostruke
sterilne barijere
Ne upotrebljavajte
ako su sterilizacijska
zaštita ili pakiranje
proizvoda oštećeni
Zemlja
proizvodnje
Ocijenjena
sukladnos UK-a
Za UK odgovara Uvoznik
(Samo za proizvode
uvezene u Veliku
Britaniju)
hu Orvostechnikai
eszköz
MRI
szempontjából
biztonságos
Besugárzással
sterilizálva
Egyszeres
sterilgát-rendszer
Ne használja fel a
terméket, ha a steril
védőcsomagolás
vagy a csomagolás
megsérült
A gyártó
országa
Felmért egyesült
királysági
megfelelőség
Egyesült
királysági felelős
személy
Importőr
(Csak Nagy-
Britanniába importált
termékek esetén)
it Dispositivo
medico
Compatibile
con RM
Sterilizzato con
irradiazione
Sistema a barriera
sterile singola
Non utilizzare il
prodotto se la
barriera sterile o la
confezione sono
danneggiate
Paese di
produzione
Conformità
Regno Unito
verificata
Persona
responsabile nel
Regno Unito
Importatore
(Solo per prodotti
importati in Gran
Bretagna)
5
Symbol
Indication
CN
ja 医療機器 MR適合 用した
滅菌
シング バリア
ステム
バリア
または包
して 場 合 は使
用しこと
造業者の国 英国適合性評価 英国責任者 輸入業
入され
み)
lt Medicinos
priemonė
Saugi naudoti
MR aplinkoje
Sterilizuota
spinduliuote
Viengubo sterilaus
barjero sistema
Nenaudokite
gaminio, jeigu
pažeista jo sterili ar
išorinė pakuotė
Gamintojo šalis JK atitiktis
įvertinta
JK atsakingas
asmuo
JK atitiktis įvertinta
(
Tik į Didžiąją Britaniją
importuojamiems
produktams)
lv Medicīniskā
ierīce
MR droša Sterilizēta, izmanto-
jot apstarošanu
Vienas sterilas bar-
jeras sistēma
Nelietot izstrādāju-
mu, ja tā sterilizāci-
jas barjera vai iepa-
kojums ir bojāts
Ražotājvalsts AK atbilstības
novērtējums
AK atbildī
persona
Importētājs
(Attiecas tikai uz
Lielbritānijā importē-
tajiem produktiem)
nl Medisch
hulpmiddel
MR-veilig Gesteriliseerd door
bestraling
Enkelvoudig steriel
barrièresysteem
Gebruik het product
niet wanneer de
steriele barrière
of de verpakking
beschadigd is
Land van
fabrikant
Op conformiteit
beoordeeld in
het VK
Verantwoordelijke
voor het VK
Importeur
(Alleen voor naar
Groot-Brittannië
geïmporteerde
producten)
no Medisinsk
utstyr
MR-sikker Sterilisert
med stråling
Enkelt sterilt
barrieresystem
Produktet må ikke
brukes hvis produk-
tets sterile barriere
eller emballasjen er
skadet
Produksjonsland
UK Conformity
Assessed
Ansvarlig person
i Storbritannia
Importør
(Kun for produkter
importert til
Storbritannia)
6
Symbol
Indication
CN
pl Wyrób
medyczny
Bezpieczny w
trakcie badania
rezonansem
magnetycz-
nym
Sterylizowany
radiacyjnie
System pojedynczej
bariery sterylnej
Produktu nie należy
używać, jeśli jego
sterylna osłona jest
nieszczelna lub
opakowanie jest
uszkodzone
Kraj producenta Ocena zgodności
w Wielkiej
Brytanii
Osoba
odpowiedzialna
w Wielkiej
Brytanii
Importer
(Dotyczy tylko
produktów
importowanych do
Wielkiej Brytanii)
pt Dispositivo
médico
MR seguro Esterilizado por
irradiação
Sistema de barreira
estéril único
Não utilize se a bar-
reira de esteriliza-
ção do produto ou
a respetiva emba-
lagem estiverem
danificadas
País do
fabricante
Avaliação de
conformidade do
Reino Unido
Pessoa
responsável no
Reino Unido
Importador
(Apenas para
produtos
importados para a
Grã-Bretanha)
ro Dispozitiv
medical
Sigur pentru
utilizarea cu
aparate de
RMN
Sterilizat prin
iradiere
Sistem cu ecran
steril unic
A nu se utiliza
dacă ecranul
de sterilizare a
produsului sau
ambalajul acestuia
este deteriorat
ara
producătorului
Evaluare de
conformitate UK
Persoana
responsabilă
pentru UK
Importator
(Numai pentru
produsele
importate în Marea
Britanie)
sk Zdravotnícka
pomôcka
Bezpečné pre
prostredie MR
Sterilizované
ožarovaním
Systém jednej
sterilnej bariéry
Výrobok nepoužívaj-
te, ak je poškodená
sterilná bariéra
alebo obal výrobku
Krajina výrobcu Hodnotenie
zhody s predpis-
mi Spojeného
kráľovstva
Odgovorna
oseba v
Združenem
kraljestvu
Dovozca
(Len pre produkty
dovážané do Veľkej
Británie)
7
Symbol
Indication
CN
sl Medicinski
pripomoček
Varno za MR Sterilizirano z
obsevanjem
Enojni sterilni
pregradni sistem
Izdelka ne
uporabljajte,
če je
sterilna zaščita ali
embalaža izdelka
poškodovana
Država
proizvajalca
Ocena skladnosti
v Združenem
kraljestvu
Zodpovedná
osoba pre
Spojené
kráľovstvo
Uvoznik
(Samo za izdelke,
uvožene v Veliko
Britanijo)
sv Medicinteknisk
produkt
MR-säker Steriliserad med
strålning
Enkelt sterilbarriär-
system
Får inte användas
om produktens
sterilbarriär eller
förpackning är
skadad
Tillverkningsland
Brittisk över-
ensstämmelse
bedömd
Ansvarig person,
Storbritannien
Importör
(Endast för
produkter som
importeras till
Storbritannien)
tr Tıbb Chazdır MR çn güvenl Radyasyonla
sterlze edlmştr
Tekl sterl baryer
sstem
Ürünün
sterlzasyon
baryer ya da
ambalajı hasarlıysa
ürünü kullanmayın
Üretldğ ülke
Brleşk Krallık
Uygunluğu
Değerlendrlmştr
BK Sorumlusu İthalatçı
(Yalnızca Büyük
Brtanya’ya thal
edlen ürünler çn)
zh 医疗器MR 安全 采用辐照灭菌
单层无菌屏障系统
如果产品的无菌屏
障或包装损坏,
得使用本产品
制造商所属国
家/地区
英国合格英国负责人 进口商
(仅进口到英国
产品)
6
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Content Page
English ..................................................................................................................................10-15
 ............................................................................................................................. 16-22
Česky .....................................................................................................................................23-28
Dansk ....................................................................................................................................29-34
Deutsch ................................................................................................................................35-41
Ελληνικά ...............................................................................................................................42-48
Español .................................................................................................................................49-55
Eesti .......................................................................................................................................56-61
Suomi ....................................................................................................................................62-67
Français ................................................................................................................................68-74
Hrvatski ................................................................................................................................75-80
Magyar .................................................................................................................................81-87
Italiano .................................................................................................................................88-94
Content Page
日本語 .............................................................................................................................. 95-100
Lietuviškai ......................................................................................................................101-106
Latviski ............................................................................................................................107-113
Nederlands ....................................................................................................................114-120
Norsk ................................................................................................................................121-126
Polski ................................................................................................................................127-133
Português .......................................................................................................................134-140
Romania ..........................................................................................................................141-147
Slovenčina ......................................................................................................................148-154
Slovenšcina ....................................................................................................................155-161
Svenska ...........................................................................................................................162-167
Türkçe ..............................................................................................................................168-173
中文 .................................................................................................................................174-179
10
8. Do not perform direct intubation through
AuraOnce as the endotracheal (ET) tube may get
stuck leading to insufficient ventilation.
9. In general, AuraOnce should only be used in
patients who are profoundly unconscious and
will not resist insertion.
10. The overall complication rate for laryngeal mask
is low, but the user must exercise professional
judgement when deciding whether the use of a
laryngeal mask will be appropriate.
The following patients are at higher risk of
serious complications including aspiration and
inadequate ventilation:
Patients with upper airway obstruction.
Non-fasted patients (including those cases
where fasting cannot be confirmed).
Patients suffering from upper gastrointestinal
issues (e.g., esophagectomy, hiatal hernia,
gastroesophageal reflux disease, morbid
obesity, pregnancy > 10 weeks).
Patients requiring high pressure ventilation.
Patients who present with pharyngeal/
laryngeal pathology potentially complicating
anatomical fit of the mask (e.g., tumors,
radiotherapy to the neck involving the
hypopharynx, severe oropharyngeal trauma).
Patients with inadequate mouth opening to
permit insertion.
1.1. Intended use/Indication for use
The Ambu AuraOnce is intended for use as an
alternative to a facemask for achieving and
maintaining control of the airway during routine and
emergency anaesthetic procedures in fasted patients.
1.2. Intended users and use environment
Medical professionals trained in airway management.
AuraOnce is intended to be used in a hospital setting.
1.3. Intended patient population
Adult and pediatric patients from 2 kg and above
evaluated as eligible for a supraglottic airway.
1.4. Contraindications
None known.
1.5. Clinical benefits
Keeps the upper airway open to allow passage of gases.
1.6. Warnings and cautions
Before insertion, it is essential that all medical
professionals using Ambu AuraOnce are familiar
with the warnings, precautions, indications, and
contraindications found in Instruction for use.
WARNINGS
1. The product is intended to be used by medical
professionals trained in airway management only.
2. Always visually inspect the product and perform
a functional test after unpacking and prior to
use according to section 3.1 Preparation before
use, as defects and foreign matters can lead to
no or reduced ventilation, mucosal damage, or
infection of the patient. Do not use the product
if any steps in Preparation before use fails.
3. Do not re-use AuraOnce on another patient as it
is a single use device. Re-use of a contaminated
product can lead to infection.
4. AuraOnce does not protect the trachea or lungs
from the risk of aspiration.
5. Do not use excessive force when inserting
and removing AuraOnce as this can lead to
tissue trauma.
6. The cuff volume or pressure may change in
the presence of nitrous oxide, oxygen, or other
medical gases which can lead to tissue trauma.
Ensure to monitor cuff pressure continuously
during the surgical procedure.
7. Do not use AuraOnce in the presence of lasers
and electrocautery equipment as this could lead
to airway fire and tissue burns.
11
en
CAUTIONS
1. Do not soak, rinse, or sterilize this device as these
procedures may leave harmful residues or cause
malfunction of the device. The design and material
used are not compatible with conventional
cleaning and sterilization procedures.
2. Before use, always check for compatibility
between AuraOnce and the external device to
avoid the use of devices not being able to pass
through lumen of AuraOnce.
3. The cuff pressure should be kept as low as
possible while still providing sufficient seal and
should not exceed 60 cmHO.
4. Any signs of airway problems or inadequate
ventilation must be monitored regularly and
AuraOnce must be repositioned, reinserted or
replaced as required to maintain a patent airway.
5. Always reconfirm the patency of the airway after
any change in the patient's head or neck position.
1.7. Potential adverse events
The use of laryngeal masks is associated with
minor adverse effects (e.g., sore throat, bleeding,
dysphonia, dysphagia) and major adverse effects
(e.g., regurgitation/aspiration, laryngospasm,
nerve injury).
1.8. General notes
If, during the use of this device or as a result of its use,
a serious incident has occurred, please report it to the
manufacturer and to your national authority.
2.0. Device description
AuraOnce is a sterile, single-use laryngeal mask
consisting of a curved patient tube with an inflatable
cuff at the distal end. The cuff can be inflated through
the check valve allowing the pilot balloon to indicate
the inflation/deflation status. The cuff conforms to
the contours of the hypopharynx and with its lumen
facing the laryngeal opening of the patient. The tip
of the cuff presses against the upper oesophageal
sphincter and the proximal end of the cuff rests
against the base of the tongue.
AuraOnce comes in 8 different sizes. The main
components of AuraOnce are seen in figure 1.
Figure 1 (page 8): Overview of AuraOnce parts:
1. Connector; 2. Patient tube; 3. Cuff; 4. Check
valve; 5. Pilot balloon; 6. Pilot tube; 7. Nominal
length of internal ventilatory pathway*.
*See Table 1 for the nominal length provided
in centimeters.
Figure 2 (page 8): Correct position of
AuraOnce in relation to AuraOnce parts
and anatomical landmarks
AuraOnce parts: 1. Inflatable cuff; 2. Size marking;
3. Ventilatory opening; 4. Ventilatory pathway;
5. Normal depth of insertion marks; 6. Machine end.
Anatomical landmarks: A. Esophagus; B. Trachea;
C. Cricoid ring; D. Thyroid cartilage; E. Vocal cords;
F. Laryngeal inlet; G. Epiglottis; H. Hyoid bone;
I. Tongue; J. Buccal cavity; K. Nasopharynx;
L. Incisors.
COMPATIBILITY WITH OTHER DEVICES/EQUIPMENT
AuraOnce can be used in conjunction with:
Ventilation equipment; 15 mm conical connectors
in compliance with ISO 5356-1.
Airway management devices; Bronchoscopes and
exchange catheters*.
Other accessories; Standard 6 % conical Luer
syringe, Manometer with standard 6 % conical Luer
connector, Water-based lubrication, Suction catheter.
When using instruments through the mask ensure
that the instrument is compatible and well lubricated
before insertion.
* See Table 1 for information on maximum instrument size.
12
3.0. Product use
3.1. Preparation before use
SIZE SELECTION
Ambu AuraOnce comes in different sizes for use in
patients of different weights.
For pediatric patients, it is recommended that Ambu
AuraOnce is used by a medical professional familiar
with pediatric anesthesia.
See selection guidelines and max. intracuff pressure in
Table 1, section 4.0. (Specifications).
INSPECTION OF AURAONCE
Always wear gloves during the preparation and insertion
of Ambu AuraOnce to minimize contamination.
Handle AuraOnce carefully as it can be torn or
punctured. Avoid contact with sharp or pointed objects.
Check that the pouch seal is intact before opening
and discard Ambu AuraOnce if the pouch seal has
been damaged.
Closely examine AuraOnce for any damage, such as
perforation, scratches, cuts, tears, loose parts, sharp
edges etc.
Make sure that the cuff protector has been removed
from the cuff.
Check that the interior of the patient tube and the cuff
are free from blockage and any loose parts. Do not use
AuraOnce if it is blocked or damaged.
Deflate the cuff of AuraOnce completely. Once
deflated, check the cuff thoroughly for any wrinkles
or folds. Inflate the cuff to the volume as specified in
Table 1. Check that the inflated cuff is symmetrical and
smooth. There should not be any bulge nor any sign
of leakage in the cuff, pilot tubing or pilot balloon.
Deflate the cuff again before insertion.
3.2. Preparations for use
PREINSERTION PREPARATION
Deflate the cuff completely so that the cuff is flat and
free of wrinkles by pressing the cuff down onto a flat
sterile surface (e.g., a piece of sterile gauze) while at
the same time deflating the device with a syringe
3
.
Lubricate the posterior tip of the cuff prior to
insertion by applying a sterile, water-based
lubricant to the distal posterior surface of the cuff.
Always have a spare Ambu AuraOnce ready for use.
Pre-oxygenate and use standard
monitoring procedures.
Check that the level of anesthesia (or unconsciousness)
is adequate before attempting insertion. The insertion
should be successful at the same level of anesthesia
that would be suitable for tracheal intubation.
The head of the patient should be positioned
extended with flexion of the neck in a position
normally used for tracheal intubation (i.e., “the
sniffing position”).
3.3. Insertion
Never use excessive force.
Hold the patient tube with the thumb on the
vertical line close to the machine end of the patient
tube and three fingers placed on the opposite side
of the patient tube. Your other hand should be
placed under the patients head 4.
Insert the tip of the cuff pressing upwards against
the hard palate and flatten the cuff against it 5.
Verify that the tip of the cuff is flattened against
the palate before proceeding – push the jaw gently
downwards with your middle finger to open the
mouth further.
Ensure that the tip of the cuff avoids entering the
valleculae or the glottic opening and does not
become caught up against the epiglottis or the
arytenoids. The cuff should be pressed against the
patient’s posterior pharyngeal wall.
13
en
When the mask is in place, resistance will be felt.
After insertion ensure lips are not trapped between
patient tube and teeth to avoid trauma to lips.
INSERTION PROBLEMS
For pediatric patients, a partial rotational technique
is recommended in case of placement difficulties.
Coughing and breath-holding during Ambu
AuraOnce insertion indicates inadequate depth
of anesthesia – Immediately deepen anesthesia
with inhalational or intravenous agents and initiate
manual ventilation.
If you cannot open the patient’s mouth sufficiently
to insert the mask, check that the patient is
adequately anesthetized. Ask an assistant to pull
the jaw downwards thus making it easier to see into
the mouth and verify the position of the mask.
For difficulty in maneuvering the angle at the back
of the tongue when inserting AuraOnce, press the
tip against the palate throughout or else the tip
may fold on itself or meet an irregularity in the
posterior pharynx, e.g., hypertrophied tonsils.
Should the cuff fail to flatten or begin to curl over
as it is inserted, withdraw the mask and reinsert
it. In case of tonsillar obstruction, a diagonal
movement of the mask is recommended.
3.4. Fixation
If deemed necessary, secure AuraOnce to the patient’s
face with adhesive tape or with a mechanical tube
holder suited for this purpose. 7 It is recommended
to use a gauze bite block.
3.5. Inflation
Without holding the tube, inflate the cuff with just
enough air to obtain a seal, equivalent to intracuff
pressures of a maximum of 60 cmHO. 6 Often
only half of the maximum volume is sufficient to
achieve a seal – please refer to Table 1 for maximum
intracuff volumes.
Monitor the cuff pressure continuously during the
surgical procedure with a cuff pressure gauge. This
is especially important during prolonged use or
when nitrous oxide gases are used.
Look for the following signs of correct placement:
The possible slight outward movement of the tube
upon cuff inflation, the presence of a smooth oval
swelling in the neck around the thyroid and cricoid
area, or no cuff visible in the oral cavity.
The mask may leak slightly for the first three or four
breaths before settling into position in the pharynx.
In case leakage persists, check that there is adequate
depth of anesthesia and that the pulmonary inflation
pressures are low before assuming that reinsertion
of AuraOnce is necessary.
3.6. Verification of correct position
Correct placement should produce a leak-free seal
against the glottis with the tip of the cuff at the
upper oesophageal sphincter.
The vertical line on the patient tube should be
oriented anteriorly towards the patient’s nose.
AuraOnce is inserted correctly when the patient’s
incisors are between the two horizontal lines on the
patient tube. 2, item 5. Reposition the mask if the
patient’s incisors are outside this range.
The position of AuraOnce can be assessed by
capnography, by observation of changes in tidal
volume (e.g., a reduction in expired tidal volume),
by auscultating bilateral breath sounds and an
absence of sounds over the epigastrium and/or by
observing chest rise with ventilation. If you suspect
that AuraOnce has been positioned incorrectly,
remove and reinsert – and ensure that anesthetic
depth is adequate.
Visual confirmation of anatomically correct position
is recommended, e.g., by using a flexible scope.
UNEXPECTED REGURGITATION:
Regurgitation may be caused by inadequate
level of anesthesia. The first signs of regurgitation
may be spontaneous breathing, coughing or
breath-holding.
14
If regurgitation occurs, if oxygen saturation remains
at acceptable levels, AuraOnce should not be
removed. This should be managed by putting
the patient in a “head-down” position. Briefly
disconnect the anesthetic circuit so that the gastric
contents are not forced into the lungs. Check
that anesthetic depth is adequate and deepen
anesthesia intravenously, if appropriate.
Apply suction through the masks patient tube and
through the mouth. Suction the tracheobronchial
tree and inspect the bronchi using a flexible scope.
3.7. Usage with other devices/equipment
ANESTHETIC SYSTEM AND VENTILATION BAG
The mask can be used for either spontaneous or
controlled ventilation.
During anesthesia, nitrous oxide may diffuse
into the cuff causing an increase in cuff volume/
pressure. Adjust cuff pressure just enough to obtain
an adequate seal (cuff pressure should not exceed
60cmHO).
The anesthetic breathing system must be adequately
supported when connected to AuraOnce to avoid
rotation of the mask.
USAGE WITH SPONTANEOUS VENTILATION
AuraOnce is suitable for spontaneously breathing
patients when used with volatile agents or intravenous
anesthesia on condition that anesthesia is adequate
to match the level of surgical stimulus and the cuff is
not overinflated.
USAGE WITH POSITIVE PRESSURE VENTILATION
When applying positive pressure ventilation, ensure
that the seal is adequate. To improve the seal the
following is suggested:
Optimize placement of AuraOnce by head turning
or traction.
Adjust the cuff pressure. Try both lower and higher
pressures (a poor cuff seal may be caused by either
too low or too high cuff pressure).
If leakage should occur around the cuff, remove the
mask and reinsert while ensuring that anesthetic
depth is adequate.
MAGNETIC RESONANCE IMAGING MR
AuraOnce is MR-safe.
3.8. Removal procedure
Removal should always be carried out in an area where
suction equipment and the facility for rapid tracheal
intubation are available.
Do not remove AuraOnce with the cuff fully inflated to
prevent tissue trauma and laryngospasm.
3.9. Disposal
Dispose of used Ambu AuraOnce in a safe manner
according to local procedures.
4.0. Specifications
Ambu AuraOnce is in conformity with ISO11712
Anaesthetic and respiratory equipment –
Supralaryngeal airways and connectors.
15
en
Pediatric Adult
Mask Size #1 #1½ #2 #2½ #3 #4 #5 #6
Patient weight 2 – 5 kg 5 – 10 kg 10 – 20 kg 20 – 30 kg 30 – 50 kg 50 – 70 kg 70 – 100 kg > 100 kg
Maximum intracuff volume 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml
Maximum intracuff pressure 60 cmHO
Connector 15 mm male (ISO 5356-1)
Maximum instrument size* 4.5 mm 5.0 mm 6.5 mm 8.2 mm 8.5 mm 9.5 mm 11.0 mm 11.0 mm
Inflation Valve Luer cone compatibility Luer cone compatible with ISO 594-1 and ISO 80369-7 compliant equipment
Appropriate storage condition 10 °C (50 °F) to 25 °C (77 °F)
Approximate mask weight 10 g 14 g 20 g 28 g 32 g 44 g 63 g 77 g
Internal volume of ventilatory pathway 5.1 ± 0.6 ml 7.5 ± 0.7 ml 10.9 ± 0.6 ml 13.8 ± 0.4 ml 13.6 ± 0.4 ml 19.4 ± 0.6 ml 27.3 ± 0.5 ml 33.1 ± 0.5 ml
Pressure drop as determined according to
ISO 11712 annex C
0.3 cmHO at
15 l/min
0.2 cmHO at
15 l/min
0.2 cmHO at
30 l/min
0.2 cmHO at
30 l/min
0.3 cmHO at
60 l/min
0.3 cmHO at
60 l/min
0.2 cmHO at
60 l/min
0.2 cmHO at
60 l/min
Min. Interdental gap 13 mm 15 mm 17 mm 20 mm 21 mm 24 mm 27 mm 29 mm
Nominal length of the Internal
ventilatory pathway 10.5 ± 0.6 cm 12.3 ± 0.7 cm 14.1 ± 0.8 cm 16.2 ± 1.0 cm 16.2 ± 1.0 cm 18.2 ± 1.1 cm 20.4 ± 1.2 cm 21.8 ± 1.3 cm
Table 1: Specifications for Ambu AuraOnce.
* The maximum instrument size is intended as a guide for selecting the appropriate diameter of a device to be passed through the patient tube of AuraOnce.
A full list of symbol explanations can be found on https://www.ambu.com/symbol-explanation
© Copyright 2021 Ambu A/S, Denmark. All rights reserved.
No part of this documentation may be reproduced in any form, including photocopying, without the prior written permission of the copyright owner.
16
4. AuraOnce     
    .
5.      -
    AuraOnce,   
      .
6.       
      ,
     
,      
 .  
     
 .
7.   AuraOnce  
    ,
        
   .
8.     
AuraOnce,    (ET)
   ,    
 .
9.   AuraOnce    
  ,    
      
.
1.1. /  
 Ambu AuraOnce   
       
    -  
     
      
        .
1.2.     
 
 ,   
    .
 AuraOnce   
   .
1.3.   
      
2 kg,      
 .
1.4. 
  .
1.5. 
    ,
     .
1.6.    
     
,  Ambu AuraOnce, 
   , 
,   ,
     .

1.     
   , 
    
 .
2.     
    -
   ,  
3.1 „  “,  
      
      -
,     
.   ,  
     
   .
3.    AuraOnce  
,      
.    -
      .
17
bg
10.     
   ,  
    ,
    
    .
     -
   , 
   :
    
 .
,    „  
( ,    
   ).
,    -
  (. ,
 , 
 ,  ,
 > 10 ).
,     
 .
    /
,    
    (.
,   , 
,  
).
,      
  ,   
.
 
1.  ,  
  ,   
     
     .
     
   
   .
2.    
  AuraOnce  
,     
,      
  AuraOnce.
3.      
  -,  
  ,  
   60 cmHO.
4.     
   
     ,
 AuraOnce    ,
   ,  
,     
   .
5.   
    
       
  .
1.7.   
      
   (.  ,
, , )  
  (. /,
,   ).
1.8.  
         
     
,       
  .
2.0.   
AuraOnce     
 ,    
      
.      
 ,    
     /.
     ,
       
 .      
  ,   
      .
AuraOnce    8  .
   AuraOnce  
  1.
18
 1 (страница 8):   
  AuraOnce:
1. ; 2.  ; 3. ;
4.  ; 5.  ;
6.  ; 7.   
  *.
*  1   ,
  .
 2 (страница 8):   
AuraOnce     
     AuraOnce:
1.  ; 2.   ;
3.  ; 4.  ;
5.     
; 6.   .
 : A. ;
B. ; C.  ;
D. ; E.  ;
F.  ; G. ; . 
; I. ; J.  ; K. ;
L. .
   /
AuraOnce       :
  ; 15 mm 
    ISO 5356-1.
    
  ;  
 *.
 ;  6 % 
 ,   
6%   ,   
,  .
    ,
 ,      
  .
*   1   
   .
3.0.   
3.1.   
  
Ambu AuraOnce      
     .
     Ambu
AuraOnce      ,
   .
     . 
     1,  4.0.
().
  AURAONCE
      
   Ambu AuraOnce,    
 .
    AuraOnce, 
       . 
     .
     
,    ,  
 Ambu AuraOnce,    .
  AuraOnce  , 
, , , ,
 ,    .
 ,      
 .
     
      
.   AuraOnce,   
  .
19
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    AuraOnce. 
     
    .  
 ,    1.  
     .  
        
    ,  
  .   
 .
3.2.   
  
  ,     
   ,    
   (. 
 ),  
    3.
     
,    
     
  .
      Ambu
AuraOnce,   .
    -
    .
     ( -
)  ,   
.     
    ,   
   .
      
       ,
     
 (.. „  “).
3.3. 
    .
    
      
      ,
    
 .     
      4.
   , 
    ,  
   5.
 ,       
,    –  
     ,  
  .
      
          
  .  
     
  .
    ,   
.
   ,    
     ,
     .
  
    
     
  .
      
   Ambu AuraOnce 
   
–    
   , 
  .
       
,    , 
    .
     ,
         
   .
    
       
20
AuraOnce,     
 ,      
        
    , 
 .   
      , 
 ,     
.      
    .
3.4. 
   ,  AuraOnce
        
  ,    . 7
     
 .
3.5. 
   ,   
 ,     ,
    
  60cmHO. 6   
     
   –   1 
   .
   
    
      .
     
     ,
  .
     
:     
     ,
      
     
,      
 .
       
  ,     
  .    
,    
      
   ,  
,     
 AuraOnce.
3.6.    
    
       
    .
    
      
 .
 AuraOnce   ,
      
    
. 2,  5. 
,      
 .
  AuraOnce    
 ,    -
    (.  
  ),  
      -
    ,  /
     
  .  ,  
AuraOnce   , 
    ,   , 
    .
    
  ,  
  .
 :
     
   . 
      
,     .
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Ambu AuraOnce™ Disposable Laryngeal Mask Instrucțiuni de utilizare

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Instrucțiuni de utilizare