Mini Perfit ACE Neck Collar
Product Information:
- This product is MR Safe.
- Single patient multiple use.
- Country of manufacturer: Medical Device
- Ambu is a registered trademark of Ambu A/S, Denmark.
Product Usage Instructions:
- Push buttons located on the collar for adjustment.
- Ensure the chin piece is in the correct position and that the
size is fixed at all times during use to prevent detachment and
potential neck injury. - Do not re-use the collar on another patient. It is intended for
single patient use to avoid contamination and infections. - Do not use the collar on a patient for more than 24 hours as
prolonged use may lead to the development of pressure ulcers. - 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.
Contact Information:
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
T +45 72 25 20 00
ambu.com
INSTRUCTIONS FOR USE
Ambu® Mini Perfit ACETM
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C. PushBd.LoatwLcnhaAtesc.sahPfoetuuyslltlionucpkssafStytelopckss for adjustment
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EN This product is MR Safe.
Single patient multiple use
BG .
CS Tento výrobek je MR bezpecný.
DA Dette produkt er MR-sikkert.
DE Dieses Produkt ist MR-sicher.
EL MR.
ES Este producto es compatible con RM.
ET Toode on MR-kindel.
FI Tämä tuote on MK-turvallinen.
FR Ce produit ne présente aucun danger en cas d’IRM.
HR Ovaj proizvod siguran je za upotrebu uz MR.
HU Ez a termék MR-biztos.
IT Questo prodotto è compatibile con RM.
JA MR
LT
Sis gaminys yra saugus naudoti su magnetinio rezonanso (MR) ranga.
LV Sis ir MR vid lietosanai dross produkts.
NL Dit product is MR-veilig.
NO Dette produktet er MR-sikkert.
PL
Ten produkt mona stosowa bezpiecznie w badaniach rezonansu magnetycznego.
PT Este produto é seguro para utilização em IRM.
RO Acest produs este sigur pentru utilizare în IRM.
RU
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SK Tento produkt je bezpecný na pouzitie pri MR.
SL
Ta izdelek je varen za uporabo z magnetno resonanco.
SV Denna produkt är MR-säker.
TR Bu ürün MR güvenlidir.
ZH MR
CN
Country of manufacturer Medical Device
Ambu is a registered trademark of Ambu A/S, Denmark.
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Content
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English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 06 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 08 Cesky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Suomi. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Hrvatski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Magyar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Italiano. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Lietuviskai. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Latviski. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Nederlands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Romania . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Slovencina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Slovenscina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Svenska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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: Operational Temperature:
Tested at -40 °C (-40 °F) and +70 °C (158 °F) according to EN 1789. -10 °C +40 °C (14 °F 104 °F).
3.0. Use of the Ambu® Mini Perfit ACETM · 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
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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.
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492 2810 40 V08 2022/09 Printed in China. TCC 11308
Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark T +45 72 25 20 00 ambu.com
Ambu - Single-use devices that save lives
