Ambu Mini Perfit ACE User manual

Instructions for use
Ambu® Mini Pert ACE™

Stepsfor adjustment
A.Pullupsafty locks
C.Pushdownsaftylocks
Latchesin
Latchesout
B.
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Ambu is a registered trademark of Ambu A/S, Denmark.
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CN
EN This product is MR Safe. Single patient multiple use Country of manufacturer Medical Device
BG Този продукт е безопасен при МР. За многократна употреба
от един пациент Държава на производителя Медицинско изделие
CS Tento výrobek je MR bezpečný. K opakovanému použití u
jednoho pacienta Země výrobce Zdravotnický
prostředek
DA Dette produkt er MR-sikkert. Flergangsbrug til enkelt patient Producentland Medicinsk udstyr
DE Dieses Produkt ist MR-sicher. Mehrfachverwendung bei
einem Patienten Produktionsland Medizinprodukt
EL Αυτό το προϊόν είναι ασφαλές για MR. Για πολλαπλές χρήσεις σε
έναν ασθενή Χώρα κατασκευαστή Ιατροτεχνολογικό
προϊόν
ES Este producto es compatible con RM. Varios usos en un único paciente País de origen del
fabricante Producto sanitario
ET Toode on MR-kindel. Korduskasutuseks ühe patsiendiga Tootja riik Meditsiiniseade
FI Tämä tuote on MK-turvallinen. Yhden potilaan käyttöön,
monta käyttökertaa Valmistusmaa Lääkinnällinen laite
FR Ce produit ne présente aucun danger en cas d’IRM. Usage multiple pour un seul patient Pays du fabricant Dispositif médical
HR Ovaj proizvod siguran je za upotrebu uz MR. Za višekratnu upotrebu na
jednom pacijentu Zemlja proizvodnje Medicinski uređaj
HU Ez a termék MR-biztos. Egyetlen pácienshez, több
alkalommal használható eszköz A gyártó országa Orvostechnikai eszköz
IT Questo prodotto è compatibile con RM. Monopaziente, multiuso Paese di produzione Dispositivo medico
JA 本製品はMRで は 安 全 で す。 1人の患者が複数回使用できる 製造業者の国 医療装置
LT Šis gaminys yra saugus naudoti su magnetinio
rezonanso (MR) įranga. Naudoti vienam pacientui daug kartų Gamintojo šalis Medicinos prietaisas
LV Šis ir MR vidē lietošanai drošs produkts. Atkārtotai lietošanai
vienam pacientam Ražotājvalsts Medicīniskā ierīce
NL Dit product is MR-veilig. Meervoudig gebruik bij één patiënt Land van fabrikant Medisch hulpmiddel
NO Dette produktet er MR-sikkert. Til bruk flere ganger for én pasient Produksjonsland Medisinsk utstyr
PL Ten produkt można stosować bezpiecznie w
badaniach rezonansu magnetycznego. Produkt wielokrotnego użytku, dla jednego pacjenta Kraj producenta Wyrób medyczny
PT Este produto é seguro para utilização em IRM. Utilização múltipla num
único paciente País do fabricante Dispositivo médico
RO Acest produs este sigur pentru utilizare în IRM. Utilizare multiplă pentru un
singur pacient Țara producătorului Dispozitiv medical
RU Данное изделие безопасно для
использования с МРТ. Для индивидуального многоразового использования Страна-изготовитель Медицинское
устройство
SK Tento produkt je bezpečný na použitie pri MR. Na opakované použitie u
jedného pacienta Krajina výrobcu Zdravotnícka
pomôcka
SL Ta izdelek je varen za uporabo z magnetno
resonanco. Za večkratno uporabo pri enem bolniku Država proizvajalca Medicinski
pripomoček
SV Denna produkt är MR-säker. För flergångsbruk på en patient Tillverkningsland Medicinteknisk
produkt
TR Bu ürün MR güvenlidir. Tek hasta için, tekrar kullanılabilir Üretildiği ülke Tıbbi Cihazdır
ZH 本产品可在 MR 中安全使用。 可供单个患者多次使用 制造商所属国家/地区 医疗设备

Content Page
English........................................................................... 06
България ........................................................................ 08
Česky ............................................................................ 10
Dansk ............................................................................ 12
Deutsch.......................................................................... 14
Ελληνικά ......................................................................... 16
Español .......................................................................... 18
Eesti ............................................................................. 20
Suomi............................................................................ 22
Français .......................................................................... 24
Hrvatski .......................................................................... 26
Magyar........................................................................... 28
Italiano........................................................................... 30
日本語 ........................................................................... 32
Lietuviškai........................................................................ 34
Latviski........................................................................... 36
Nederlands....................................................................... 38
Norsk ............................................................................ 40
Polski ............................................................................ 42
Português........................................................................ 44
Romania ......................................................................... 46
Pусский.......................................................................... 48
Slovenčina ....................................................................... 50
Slovenšcina ...................................................................... 52
Svenska .......................................................................... 54
Türkçe ........................................................................... 56
中文 ............................................................................. 58

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1.0. Important Information – Read Before Use
All instructions must be read and understood prior to application of the collar. All directions are to be
considered as guidelines and not an attempt to define medical practice.
1.1. Intended Use
The Ambu® Mini Perfit ACE collar is a one-piece rigid cervical spine immobilization device designed to
assist the rescuer with the maintenance of neutral alignment, prevention of lateral (side-to-side) sway and
anterior-posterior (forward and backward) flexion and extension of the cervical spine during patient
transport or movement.
1.2. Contra Indications
Immobilization with a collar is not recommended in trauma patients with penetrating injuries or with
ankylosing spondylitis.
1.3. Warnings and Cautions
WARNINGS
1. The collar is intended for application by licensed health care practitioners as directed by a physician
or other medical authority. Permanent injury may result from use other than as directed by a
physician or other medical authority.
2. Do not re-use collar on another patient. The collar is for single patient use. Re-use can cause
contamination leading to infections.
3. Do not use the collar on a patient for more than 24 hours. Prolonged stay in a collar has been
associated with the development of pressure ulcers.
CAUTIONS
1. Ensure the chin piece is in correct position and that the size is fixed at all time during use as
detachment of collar during use can lead to severe neck injury.
1.4. Potential Adverse Events
Diagnostic disturbance, skin abrasion or pressure ulcers and impaired ventilation.
1.5. 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. Specifications
Storage temperature: Tested at -30 °C (-22 °F) and +70 °C (158 °F) according to EN 1789.
Operational Temperature: -10 °C ~ +40 °C (14 °F~104 °F).
3.0. Use of the Ambu® Mini Perfit ACE™
• Have one rescuer manually stabilize the head and neck, gently holding the head and neck in the
neutral alignment position. (1)
• Measure the distance between an imaginary plane drawn horizontally and immediately below the
patient’s chin and second horizontal plane drawn immediately on top of the patient’s shoulder. (2)
• Compare this distance with the distance from the collar sizing line to the lower aspect of the plastic
collar body (not the foam). (3)
• To adjust the collar, disengage the locking buttons by pulling up. (4)

EN
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• Adjust the collar to the appropriate size by pulling collar apart until the distance between the sizing
line and the collar body equals your finger measurement. (5)
• Engage the locking buttons by pushing down. (6)
• If the collar needs to be resized, disengage the locking buttons by pulling up. (7)
• Pull the ratchet latches out. (8)
• The collar may now be adjusted to the appropriate size. (9)
• Push the ratchet latches in and engage the locking buttons by pushing down. (10,11)
• Before placing the collar on the patient, ensure that the chin piece is flipped to front. (12, 13)
• Wrap the collar around the patients neck. (14, 15, 16, 18, 19, 20)
• Secure the collar using the velcro. (17, 21, 22)
• A nasal airway tubing can be attached to the tube hooks at both sides. (23)
4.0. Disposal
Used products must be disposed off according to local procedures.

492 2810 40 - V07 - 2020/08 - Printed in China - TCC 10788
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup, Denmark
T [phone]
F [phone]
ambu.com