SAM MEDICAL PS300-OB-EN Pelvic Sling II User Manual

: June 4, 2024
: SAM MEDICAL

Table of Contents

SAM MEDICAL PS300-OB-EN Pelvic Sling II
STABILIZES PELVIC FRACTURES WITH SAFE AND EFFECTIVE FORCE
- PRECAUTIONS
MR CONDITIONAL
SYMBOL GLOSSARY
References
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SAM MEDICAL PS300-OB-EN Pelvic Sling II

STABILIZES PELVIC FRACTURES WITH SAFE AND EFFECTIVE FORCE

Remove objects from patient’s pockets or pelvic area. Place SAM Pelvic Sling II black side up beneath patient at level of trochanters (hips).
Place the BLACK STRAP through buckle and pull completely through.
Hold ORANGE STRAP (GREEN STRAP on PS301-OD-EN) and pull BLACK STRAP in opposite direction until you hear and feel the buckle click. Maintain tension and immediately press BLACK STRAP onto surface of SAM Pelvic Sling II to secure.

NOTE: Do not be concerned if you hear a second “click” after SAM Pelvic Sling II is secured. The Velcro® attachment secures the Sling in place at the correct force, regardless of buckle engagement.
TO REMOVE: Lift BLACK STRAP by pulling upward. Maintain tension and slowly allow SAM Pelvic Sling II to loosen.

INTENDED USE: The SAM Pelvic Sling II is a non-invasive, circumferential pelvic belt intended to stabilize pelvic fractures during transport to a definitive care facility.

INDICATIONS FOR USE: The SAM Pelvic Sling II is indicated for application by prehospital and medical professionals or trained personnel, to individuals who have, or are suspected of having, a pelvic ring fracture where hemorrhage might occur.

CONTRAINDICATIONS: Do not utilize the SAM Pelvic Sling if anatomical landmarks are absent.

PRECAUTIONS

Remove objects from patient’s pockets and clothing prior to application.
Monitor the patient’s skin for pressure injury while in use.
Device is single use only.
Reuse of device may cause illness (e.g., infection) or injury (reduced performance).
Dispose of used device per healthcare facility biohazard protocol.

Notice to EU Users and/or Patients: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

PS300-OB-EN / SMALL Hip Circumference 27 – 45 in | 69 – 114 cm
PS301-OB-EN / STANDARD Hip Circumference 32 – 50 in | 81 – 127 cm
PS301-OD-EN / STANDARD Hip Circumference 32 – 50 in | 81 – 127 cm
PS302-OB-EN / LARGE Hip Circumference 36 – 54 in | 91 – 137 cm
(NSN# 6515-01-509-6866)

MR CONDITIONAL

Non-clinical testing demonstrated that the SAM Pelvic Sling II is MR Conditional.
A patient wearing this device can be scanned safely in an MR system under the following conditions:
Static magnetic field of 3-Tesla or less.
Important Note: The SAM Pelvic Sling II contains ferromagnetic parts and, therefore, it must be firmly attached to the patient undergoing an MRI examination. The
ferromagnetic parts may affect image quality if they are in the area of interest for the MRI examination. The SAM Pelvic Sling II must not be repositioned or removed from the patient in the presence of a powerful magnetic field, such as that associated with an MR system.

CLINICAL INFORMATION FOR USERS:
SAM Pelvic Sling II and IFU familiarization and training as well as adherence to healthcare organization evidence-based standards of care and clinical guidelines including use of PPE, are required for safe use of this product. Failure to utilize this device in a manner consistent with the IFU, training, and within clinical best practice guidelines, may result in serious illness or injury.