Ambu Perfit ACE Collar One Piece Rigid Cervical Spine Immobilization Device Instruction Manual
- June 10, 2024
- Ambu
Table of Contents
Instructions for use
Ambu® Perfit ACE™
Perfit ACE Collar One Piece Rigid Cervical Spine Immobilization Device
This product is not made with natural rubber latex
** CE mark. The product complies with the EU Council directive concerning
Medical Devices 93/42/EEC
Ambu is a registered trademark of Ambu A/S, Denmark.
Ambu is certified according to ISO 13485.
Adjustable Collar for Extrication**
Description
The Ambu® 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 transport and routine patient care or movement. The Ambu Perfit ACE is
the only collar with 16 sizes for patient immobilization.
Principles of Immobilization
Prevention and/or further extension of damage to the cervical spine and spinal
cord is accomplished by maintaining the head and neck in a position of
“neutral alignment.” The head and neck should not be flexed forward, extended
backward, or cocked to one side or the other. The neutral alignment position
prevents damaged vertebrae or foreign bodies from rubbing and/or cutting the
spinal cord. Additionally, the neutral alignment position prevents the spinal
cord from being twisted or compressed causing physical and/or ischemic injury
to the spinal cord.
Warning
The Ambu Perfit ACE 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. An extrication collar is only part of total patient
immobilization. Single patient use.
It is important that practitioners are trained and practiced in the use and
application of the device and that all instructions are 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. Use the device only after review and approval from the
supervising medical authority.
Directions for Use
STEP 1
Have one rescuer manually stabilize the head and neck, gently holding the head
and neck in the neutral alignment position (Figure 1).
Note: If resistance is felt or an increase in patient discomfort is
noted, follow your established protocols for immobilization of the cervical
spine in the presence of known or suspected cervical dislocation.
STEP 2
Once the head and neck are manually stabilized, a second rescuer should apply
an Perfit ACE collar to the patient. Size the collar as determined below.
Applied collar must not hyper-extend patient’s neck.
STEP 3
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 (Figure 2).
STEP 4
Compare this distance with the distance from the collar sizing line to the
lower aspect of the plastic collar body (not the foam) (Figure 3).
STEP 5 SIZING
The Perfit ACE collar is preset to Neckless Size 3. If a larger size collar is
needed, disengage the safety locks by pulling UP on the buttons (Figure 4).
STEP 6
Adjust the collar to the appropriate size: the Perfit ACE provides 16 ratchet
settings between the traditional Neckless (Size 3) and Tall (Size 6). Simply
pull the collar apart until the distance between the sizing line and the
plastic collar body equals your finger measurement (Figure 5).
STEP 7
Engage the safety locks by pushing DOWN on the safety buttons (Figure 6).
STEP 8
If the Perfit ACE needs to be resized, disengage the safety locks and pull
“OUT” on the ratchet latches (“arrows”) (Figure 7, Figure 8).
The Perfit ACE may now be adjusted to smaller sizes (Figure 9).
Reset the ratchet latches by pressing “IN” on the “arrows” (Figure 10).
Now engage the safety locks by pressing DOWN on the safety buttons (Figure
11).
Collar Assembly
The collar is assembled as follows: (Figure 12)
Hold the collar near the tracheal opening with one hand. Place the index
finger on the foam side of the chin piece (on the center rivet) and the thumb
on the plastic side of the chin piece (on the center rivet) and simply flip
the chin piece from the back of the collar to the front of the collar (Figure
13 and 14). This automatically forms the chin piece and places it in the
position of function.
Application
Proper application of any extrication collar requires two individuals. The first rescuer should maintain stabilization and neutral alignment of the head and neck by grasping the head with a spread finger technique (Figure 15).
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The second rescuer should slide the front of the collar along the patient’s chest and position the chin piece.
The collar body should rest on the top of the patient’s shoulder and against the sternum without gaps (Figure16). The patient’s chin must rest securely in the chin piece in neutral alignment position (Figure 17). -
While holding the front of the collar in place, wrap the back of the collar around the back of the patient’s head and neck and secure to the front of the collar with the Velcro® tab (Figure 17).
-
Adjust the Velcro tab as necessary by holding the front cutout of the collar and tightening the Velcro tab (Figure 18).
Warning
Maintain neutral head and neck alignment during the entire procedure. Once the
collar is properly applied and the patient is immobilized, the head should not
be released. Further immobilize the head and neck with head blocks or a head
immobilizer and secure the patient to the backboard with appropriate retention
straps.
Supine Application
If the patient is supine, slide the back portion of the collar directly behind
the patient’s neck (Figure 19 or 20). The collar may be applied from either
side. Once the back portion of the collar is evenly positioned behind the
head, the front portion of the collar can be positioned under the chin (Figure
21). While maintaining the proper positioning of the collar with one hand,
attach the Velcro with the other hand (Figure 22). Ensure that the loop Velcro
tab is firmly attached and parallel to the fixed hook Velcro tab on the front
of the collar.
**Warning
Maintain neutral head and neck alignment during the entire procedure. Once the
collar is properly applied and the patient is immobilized, the head should not
be released (Figure 23). Further immobilize the head and neck with head blocks
or a head immobilizer and secure the patient to the backboard with appropriate
retention straps.
Tube hook
A nasal airway tubing can be attached to the hooks at both sides (Figure 24).
Cleaning**
To eliminate any risk of cross infection between patients it is recommended to
discard the product after use.
The surface of the product can be cleaned with water and a mild detergent or
using a disinfecting agent.
Rinse it thoroughly with clean water and allow it to dry before reuse.
Before reuse, make sure that the product is intact and fully operationable.
Otherwise it should be discarded.
Warranty/Guarantee
Ambu warrants its products to be free from defects in workmanship and materials when purchased through Ambu or its authorized channels of distribution and used in accordance with recommended procedures. Should any product be found to be defective when unpacked, obtain a return authorization number from Ambu before sending it back. Repair or replacement will be made at no charge.
**** US: Rx only
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
T +45 72 25 20 00
F +45 72 25 20 50
www.ambu.com
492 2800 00 – V06 – 2015/02 – Printed in China