FOR STABILIZATION OF PELVIC FRACTURES WITH THE CORRECT FORCE
The SAM Pelvic Sling™ II is the first and only force-controlled circumferential pelvic belt scientifically proven in peer-reviewed studies to safely and effectively reduce and stabilize open-book pelvic ring fractures. The SAM Pelvic Sling II was designed not to over-tighten or under-tighten, unlike other commercial binders which allow unlimited force to be applied to the patient. Researchers at Legacy Health System utilized cadaver studies and clinical trials to determine the optimum range of force required to safely and effectively close an unstable pelvic fracture.

The SAM Pelvic Sling II's patented Autostop buckle is programmed to stop your pull once the correct compression force has been obtained. This is vital in high stress environments where over-tightening by emergency medical personnel under duress could potentially be extreme and harmful.

Trauma surgeons around the world recognize the importance of stabilizing pelvic fractures during the critical first "golden hour" following severe trauma. Because of the potentially devastating hemorrhage associated with such fractures, standard first aid protocol includes applying some type of circumferential binder around the victim's hips.

ONE-PIECE DESIGN
The SAM Pelvic Sling II offers a simpler one-piece design with no detachable hardware. It is compact, easy to use (only three steps), and quick to apply (usually in less than one minute). The standard size fits (without cutting or trimming) 98% of the adult population. It does not require a fine touch to operate and gives clear feedback by sound and feel to confirm correct application.

The sling is durable and unaffected by extremes of moisture and temperature or by exposure to hard or sharp objects. It is also radiolucent, MRI safe, and can be cleaned for re-use with common detergents or anti-microbial solutions.

APPLIES IN 3 EASY STEPS

 

IMPORTANT WARNING
Based on in vitro testing, the SAM Pelvic Sling™ II will not present a hazard or risk to a patient undergoing an MRI procedure using an MR system operating at 3-Tesla or less. The SAM Pelvic Sling™ II contains ferromagnetic springs in the buckle. Therefore, it is important to ensure that the SAM Pelvic Sling™ II is firmly applied to the patient prior to entry into the MRI environment (as stated in the labeling for this device). Accordingly, there will be no hazard or risk to a patient undergoing an MRI procedure. The SAM Pelvic Sling™ II should not be removed from the patient while in the MRI system room.

WHY DOES CONTROLLING CIRCUMFERENTIAL FORCE MATTER IN THE TREATMENT OF PELVIC FRACTURES?

At the time of initial evaluation, the exact type of fracture is usually unknown. In some cases, too little force will not close or stabilize the fracture; in others, too much force can collapse the pelvic ring. The SAM Pelvic Sling II stands alone as the only pelvic binder pre-programmed to apply the safe and correct force for all pelvic fractures.

BENEFITS AND FEATURES
• Scientifically and clinically proven to provide safe and effective force to stabilize pelvic fractures
• Buckle maintains correct force; cannot be over-tightened
• Standard size fits 98% of population
• "Click" provides clear feedback to confirm correct application
• Pulling gradually and symmetrically increases sling tension and reduces the pelvis
• Low friction posterior slider facilitates transfers
• Front of Sling is narrow and tapered to facilitate urinary catheterization, interventional radiology, external fixation and abdominal surgery
• Fabric does not stretch and cleans for reuse with standard detergents or antimicrobial solutions
• Radiolucent (allowing for X-rays without removal)
• Ease of application: just insert belt through buckle, pull strap, and secure
• Velcro on strap and sling for quick and easy fastening
• Reusable, not a onetime use device
• Latex free

TECHNICAL DATA
Extra Small: Hip Circumference: 27"-47" (69cm x 119cm); 9oz
Standard: Hip Circumference: 32"-50" (81cm x 127cm); 9oz
Extra Large: Hip Circumference: 36"-60" (91cm x 152cm); 9oz
Military: Hip Circumference: 32"-50" (81cm x 127cm); 9oz

Made in USA

CE Approved

ISO 13485:2003

NSN# 6515-01-509-6866
Meets ASTM Standard F2428-04
Patents:
#8,192,383
#6,554,784

The SAM Pelvic Sling II is field proven and mentioned in over 74 peer-reviewed published scientific articles worldwide. Sources include academic, military and Hospital/EMS. In addition, several Prehospital emergency services organizations prescribe the SAM Sling in their protocols for treatment of suspected pelvic fractures.

Published Literature:

Laboratory Studies
Clinical Use Reports
Reviews, SAM Pelvic Sling Citation
Protocols

Laboratory Studies

Bottlang M, Krieg JC, Mohr M, Simpson TS, Madey SM. Emergent management of pelvic ring fractures with use of circumferential compression. J Bone Joint Surg Am. 2002;84-A Suppl 2:43-7.

Summary: Bottlang, Krieg et al out of Legacy Research and OHSU performed a cadaver study funded by the Office of Naval Research. "The results of this research demonstrate that circumferential compression with this noninvasive pelvic sling {SAM Pelvic Sling} is an effective and safe method for reducing and stabilizing open-book pelvic fractures at the emergency scene." The sling "is well suited for temporary stabilization of the acutely injured patient prior to and during patient transport or transfer." "The pelvic sling did not cause a significant overreduction of the unstable lateral compression fractures, it may be applied safely at the accident scene before patient transport."

Clinical Use Reports

Krieg JC, Mohr M, Ellis TJ, Simpson TS, Madey SM, Bottlang M. Emergent stabilization of pelvic ring injuries by controlled circumferential compression: a clinical trial. J Trauma. 2005 Sep;59(3):659-64.

Summary: Krieg et al [13], in a study funded by the Office of Naval Research, used a SAM Sling on 16 trauma patients with pelvic fractures (age 17-67, weight 71-104kg, duration of wear 2-192 hrs, fractures B1 B2 B3 C1 C2). The SAM Sling reduced pelvic fractures equally to the reduction achieved by subsequent definitive stabilization. "Definitive stabilization delivered a comparable reduction... to that temporarily achieved with the PCCD." "A PCCD can effectively reduce pelvic ring injuries. It poses a minimal risk for overcompression and complications as compared with reduction alternatives that do not provide a feedback on the applied reduction force." "In several alert patients anecdotal evidence of pain relieve was noted." "Artifacts on CT images caused by these springs proved negligible and did not affect posterior fracture visualization." "In addition to providing emergent stabilization, the PCCD was used in one case to maintain reduction during application of an anterior external fixator for definitive stabilization." "Results of this clinical trial suggest that the PCCD can rapidly reduce and stabilize openbook type pelvic ring injuries, without causing complications if applied to a range of pelvic ring injuries, including internal rotation type injuries that are prone to internal collapse. Albeit confined to a relatively small patient group, these findings suggest that the PCCD can be applied by paramedics at the accident scene to provide early stabilization within the 'golden hour' and before patient transport, as well as by physicians at the time of hospital admission."

Ross DW, Wichman C, Mackinnon M. Car versus bicycle: conclusion. Air Med J. 2009 Nov-Dec;28(6):268-71.

Summary: Ross et al of Penrose Hospital, review the case of a 58 yr old trauma patient transported by a helicopter air ambulance. After pelvic fractures were identified at the hospital, a compressive sling was applied, however the patient died in surgery. The article recommends a pre-hospital assessment and treatment protocol that includes using a pelvic compression device. They note that the "Sam Sling has been the subject of peer-reviewed studies" and describe Bottlang and Krieg's work. "As a reminder of this effectiveness, we recently had a patient injured in a motorcycle crash with unstable pelvic fractures who was hypotensive. He failed to respond to initial fluid and blood replacement. However, when a sling device was applied, the blood pressure increased from 70 mmHg systolic to 110 and stayed there until departure to the operating room." They conclude that "EMS crews should assess major mechanism trauma patients for pelvic injuries and, if thought to be present, should apply a compressive sling to assist in the stabilization of hemodynamics."

Cross AM, Davis C, Taylor M, de Mello W, Matthews JJ. Lower limb traumatic amputation - the importance of pelvic binding for associated pelvic fractures in blast injury. Injury Extra Volume 41, Issue 12, December 2010, Page 152

Wayne MA. New Concepts in the Prehospital and ED Management of pelvic fractures. Israeli Journal of Emergency Medicine - Vol. 6, No. 1 Feb. 2006

Bonner TJ, Eardley WG, Newell N, Masouros S, Matthews JJ, Gibb I, Clasper JC. Accurate placement of a pelvic binder improves reduction of unstable fractures of the pelvic ring. J Bone Joint Surg Br. 2011 Nov;93(11):1524-8.

Reviews, SAM Pelvic Sling Citation:

Brown KV, Guthrie HC, Ramasamy A, Kendrew JM, Clasper J. Modern military surgery: Lessons from Iraq and Afghanistan. J Bone Joint Surg Br. 2012 Apr;94(4):536-43.

Porter K, Lee C. Radiological terrorism scenarios. Prehosp Disaster Med. 2007 Nov-Dec;22(6):547.

Lee C, Porter K. The prehospital management of pelvic fractures. Emerg Med J. 2007 Feb;24(2):130-3.

Tzioupis CC, Kobbe P, Tarkin IS, Pape HC. Pelvic stabilization. Prehospital management of traumatic pelvic injuries. JEMS. 2007 Jul;32(7):64-6, 68, 70-5; quiz 76.

Williams-Johnson J, Williams E, Watson H. Management and treatment of pelvic and hip injuries. Emerg Med Clin North Am. 2010 Nov;28(4):841-59.

Protocols (Use of the SAM Pelvic Sling II is indicated in the protocols for the following organizations):

• Whatcom County EMS
• Malheur County EMS
• British Horseracing Authority
• Columbia County EMS
• Sherman County EMS
• Baldwin Area EMS
• Lee County Florida EMS
• Metro Regional EMS Consortium, Clackamas County and Washington County OR EMS
• Jackson County EMS
• Seaside Fire and Rescue
• City of Austin / Travis County EMS System
• Cleveland Clinic EMS
• Central Oregon Fire Services