Ambu Mini Perfit ACE User Manual Manual

A. Pull up safty locks C. Push down safty locks Latches in Latches out B. 1 2 3 4 5 6 7 8 9 10 11

23 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

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

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)

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.

Ambu A/S Baltorpbakken 13 DK-2750 Ballerup, Denmark T +45 72 25 20 00 F +45 72 25 20 50 ambu.com