Ambu AuraOnce™ Disposable Laryngeal Mask Istruzioni per l'uso

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 Zdravotnický

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 dovážené

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適合放射線を利用した

滅菌

シングル滅菌バリア

システム

製品の殺菌バリア

または包装が破損

している場合は使

用しないこと

製造業者の国英国適合性評価英国責任者輸入業者

（英国に輸入され

た製品のみ）

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 atbildīgā

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 医疗器械 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

障或其包装损坏，

不得使用本产品

制造商所属国

家/地区

英国合格认定英国负责人进口商

（仅限进口到英国

的产品）

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 patient’s 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 mask’s 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

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

bg

    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 Istruzioni per l'uso

Ambu AuraOnce™ Disposable Laryngeal Mask Istruzioni per l'uso

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