Ambu Mini Perfit ACE Mode D'emploi page 6

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:
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.
• 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.
• Compare this distance with the distance from the collar sizing line to the lower aspect of the plastic
collar body (not the foam).
• To adjust the collar, disengage the locking buttons by pulling up.
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Tested at -40 °C (-40 °F) and +70 °C (158 °F) according to EN 1789.
-10 °C – +40 °C (14 °F – 104 °F).
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