PATENTED TECHNOLOGY, TARGETED TO YOUR NEEDS ANJON BREMER APPLICATION, REMOVAL, AND CPR INSTRUCTIONS WWW.GENERIXMEDICAL.COM
INTRODUCTORY INFORMATION FOR THE ANJON BREMER MRI Safety Information: Non-clinical testing has demonstrated that Anjon Bremer Halo System devices are MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions: MRI scanner with a static magnetic field strength of 1.5 T or 3 T. Maximum spatial gradient field of 3,000 G/cm (30 T/m) Full body transmit/receive coil. RF quadrature coil only. Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg Under the scan conditions defined above, Anjon Bremer Halo System devices are expected to produce a maximum temperature rise of less than 5.5 ºC after 15 minutes of continuous scanning. ANTERIOR VIEW In non-clinical testing, the image artifact caused by the skull pin extend approximately 30 mm from the skull pin when imaged with a spin-echo pulse sequence in a 3.0 T MRI system. Cautions: The Anjon Bremer Light is rigidly contoured and trimmed to specifically avoid bony prominences and to rest on major muscle groups reducing the risks of skin breakdown. As such, care should be taken that alignment of the vest shell on the patient s body be very exact. A B C The Anjon Bremer Light has not been tested on patients shorter than 4 10 or taller than 6 5. The Anjon Bremer Light is not designed for modification with cast saws, scissors, heat guns, etc. E F LATERAL VIEW POSTERIOR VIEW When the Anjon Bremer Light is applied to a morbidly obese patient, extra care should be taken to examine the patient s skin on a frequent basis paying particular attention to any areas where redundant tissue contacts edges of the vest outside the padding. Contraindications: Patients with a significant degree of scoliosis or a degree of thoracic kyphosis that would prevent the upper portion of the vest from making firm contact with the trapezius muscles of the upper back are not candidates for Anjon Bremer Light application. Use 100003 Anjon Bremer Light Kyphosis model. I J K COMPONENTS: A. Anterior Vest Shell B. Superstructure C. Vest Joints D. Universal Joints E. Posterior Locking Knobs F. Thoracic Bands G. Threaded Hole H. Transverse Bar I. Halo Clamps J. Velcro Shoulder Strap and Pad K. Posterior Vest Shell L. Posterior Upright M. Medial Hole N. Locking Post O. Black Traction Knob P. Plastic Cable Tie Q. Anterior Upright
PRELIMINARY APPLICATION NOTES Anjon Bremer superstructures are equipped with unique toothed locking joints. For adjustments, these joints are designed to slide before they will rotate. Please note: When retightening, it is only necessary that bolts be firm; do no overtighten bolts when checking for tightness. Sliding adjustments require only slight bolt loosening. Rotary or angular adjustments require loosening until teeth disengage. Trying to force angular changes without disengaging teeth may result in bent uprights or damaged teeth in the joints. BEFORE APPLYING THE ANJON BREMER Note: A Anjon Bremer Halo Crown or Adjustable Ring must be applied to the patient prior to the application of the Anjon Bremer Light. MEASURE THE PATIENT Two measurements are required: 1. Patient Height 2. Circumference of patient thorax at the xiphoid process SELECT THE APPROPRIATE ANJON BREMER 100001 Short Anjon Bremer Light: Patient Height: 5 7 (170 cm) Patient circumference: 28 to 38 (72-98 cm) 100002 Tall Anjon Bremer Light: Patient Height: 5 7 (170 cm) Patient circumference: 30 to 44 (76-112 cm) 100003 Anjon Bremer Light Kyphosis: For further information, please contact GeneriX Medical.
ADJUST THE VEST TO PATIENT CIRCUMFERENCE MEASUREMENTS 1. Remove posterior locking knobs. 2a. For Even Numbered Measurements: Slide both thoracic bands until appropriate measurement aligns with threaded hole in vest 106`` 40`` 102`` 38`` 98`` 2b. For Odd Numbered Measurements: Slide one thoracic band to the 3. Re-insert and tighten locking knobs. even numbered setting higher and the second thoracic band to the even numbered setting lower than the patient s appropriate odd numbered measurement.
APPLICATION OF THE ANJON BREMER Note: For application of kyphosis vest combine this application with kyphosis application addendum. 1b. Release locks on thoracic bands. 1c. Release shoulder strap Velcro and remove anterior vest shell with uprights attached. 1a. Loosen anterior universal joints and lower traction knobs on all four uprights. 2a. Loosen posterior universal joints. 2b. Remove transverse bars and halo clamp units. 2c. Position posterior uprights parallel to each other as in (1b) above and slightly anterior of parallel to the posterior vest shell as shown above. Tighten posterior vest joints.
APPLICATION OF THE ANJON BREMER 3. While the physician maintains the patient s head and neck position, place the posterior shell of the Vest in correct alignment under the back of the supine patient using one of the following two maneuvers. 3a. Logroll Maneuver Logroll the patient fifty degrees. Slide one thoracic band under the patient. Push posterior shell into position. 3b. Lifting Maneuver Lift the patient s head and upper body approximately six inches. Taking care not to tangle any tubes or leads with the thoracic bands, slide the posterior vest shell under the patient s head and into position.
APPLICATION OF THE ANJON BREMER 4. Assure correct alignment of the posterior vest shell by manually feeling for the following landmarks: Upper edge of posterior shell should be even with the middle of C7. Upper angled portion of the posterior shell should be in form contact with the trapezius muscles of patient s upper back. The superior edge of the thoracic bands should be at the patient s xiphoid process. Openings in the middle of the posterior shell should be in line with spine at both top and bottom of the posterior shell. 5a. Attach halo clamp joints to Anjon Bremer Halo Crown 5b. Tighten posterior universal joints and halo clamps assuring transverse or Adjustable Ring and then slide each transverse bars are at the same height and parallel. bar into the posterior universal joints.
APPLICATION OF THE ANJON BREMER 6. When placing anterior vest shell, slide universal joints into position simultaneously. Note: Anterior vest joints should be loose during this maneuver. 7. Correct alignment of anterior vest shell. Sternal notch should be exposed 2 inches above the upper edge of anterior shell. Slide the thoracic bands through each guide on anterior vest shell and match a hole in the thoracic band with the locking post. Note: Thoracic bands should be symmetrical. If there is a problem with the alignment of the anterior shell, check the alignment of the posterior vest shell. Lock the thoracic bands into position. Caution: The thoracic bands at the bottom of the Anjon Bremer Light Vest should not be tightened to a point that compresses the lower ribs. Such overtightening will restrict patient breathing and may cause skin breakdown.
APPLICATION OF THE ANJON BREMER 8. With the anterior vest joints loose enough to rotate on the uprights, firmly press the sternal portion of the anterior shell flat against the sternum... continue to press while tightening the vest joints and the anterior universal joints. 9. Firmly attach the shoulder straps, adjusting and trimming the pads as 10. Logrolling the patient slightly, tighten the posterior vest joints. needed to avoid any excess pressure on the side of the neck. Note: It may be necessary to pull the patient s shoulder girdle down slightly since they are frequently elevated in a guarding reflex if the patient is recently injured. 11. Obtain lateral radiograph to check cervical alignment.
APPLICATION OF THE ANJON BREMER 12. Align cervical spine as necessary 12a. A-P Positioning: loosen top halo clamp bolts until clamp slides on transverse bars. Position appropriately and tighten firmly. 12b. Extension and Flexion: loosen lower halo clamp bolts until teeth disengage and joint rotation is possible. Rotate to desired position and tighten. 12a. Distraction: Increased by the black traction knobs on the threaded uprights. In sequence, loosen each universal joint only enough to allow it to slide on the threaded uprights. Using the black traction knobs on the threaded uprights, screw each opposing joint upwards about 1cm. Tighten each universal joint before moving to the next.
APPLICATION OF THE ANJON BREMER 13. Make a final check of all bolts for tightness. Do not overtighten. 14. Obtain a lateral radiograph with the patient erect. 15. Extra liner material will help protect the patient against chafing 16. If the patient is disoriented or non-compliant, secure the locking of thoracic bands on the chest or other pressure points. post using the black plastic cable ties included with each vest unit. Ties should be passed through the hole provided in each locking post, then passed underneath the thoracic band.
REMOVING THE SUPERSTRUCTURE 1. Place an appropriate cervical collar on the patient. 2. With the patient seated, remove both halo clamp bolts that attach the superstructure to the Anjon Bremer Halo Crown or Adjustable Ring. 3. Remove the superstructure by removing the four bolts that attach the superstructure to the Vest. Note: Lateral radiographic extension/flexion studies can be done at this point without removing Anjon Bremer Halo Crown or Adjustable Ring.
REMOVING THE 1. Release the two shoulder straps. 2. Release one thoracic band and remove the Vest shells from the patient.
ANJON BREMER EXPOSING THE CHEST FOR CPR AND LIFE SUPPORT Note: Wrench supplied with the Vest should be attached to the Vest superstructure, or patient s bed at all times. 1. Place patient supine on posterior portion of the Vest. 2. Loosen the two anterior Vest bolts using 3. Release the thoracic bands by turning the the 7/16 (11mm) wrench or, if attached, the locking posts and pull the bands out of the ICU Knobs. way. Note: If plastic cable ties are in place, cut them with scissors and remove prior to turning the locking posts. 4. Rotate the anterior shell of the Vest away 5. Using the posterior Vest shell as a crash from the body exposing the chest. board perform CPR and/or Life Support as necessary. Note: Some stability of the cervical spine is maintained as long as the patient s body remains on the posterior Vest shell, the posterior Vest uprights are secure, and the transverse bars remain firmly attached to the Anjon Bremer Halo Crown/Adjustable Ring. Recommendation Manufacturer suggests the entire nursing care team practice this procedure using a Anjon Bremer Classic Vest/ Anjon Bremer Light Vest on a resuscitation dummy.
ANJON BREMER BY Limited Warranty: Generix Medical standard catalog products are sold with a limited warranty to the original purchaser against defects in workmanship and materials; any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please see the current price list for important warranty information. Caution: Federal law restricts this device to sale by or on the order of a physician. SYMBOL TRANSLATION CONSULT INSTRUCTIONS FOR USE SINGLE USE CATALOG NUMBER AUTHORIZED EUROPEAN REPRESENTATIVE MANUFACTURED DATE MANUFACTURED BY PACKAGED NON STERILE LOT NUMBER MATL MATERIAL S STEEL DO NOT USE IF PACKAGE IS DAMAGED MRI CONDITIONAL U.S. FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE BY OR ON THE ORDER OF A PHYSICIAN QTY QUANTITY A ALUMINUM PL PLASTIC T TITANIUM WWW.GENERIXMEDICAL.COM Copyright GeneriX Medical, Inc., 2017. All rights reserved. LA0902902 - Rev. A