TS200-5P-EN SAM ThoraSite User Manual
- June 3, 2024
- SAM
Table of Contents
5P-EN SAM ThoraSite
User Manual
DEVICE TECHNOLOGY
ThoraSite is an anatomical landmark guide, designed to provide a safer approach to the pleural space by pinpointing the procedure site. 1, 2 The device aids in identifying the ppropriate intercostal space for lateral thoracostomies and similar procedures. ThoraSite is non-sterile and intended to be single use.
FREQUENTLY ASKED QUESTIONS | DEVICE
Q: What are the key benefits for using ThoraSite?****
– A: ThoraSite simplifies locating the appropriate procedure site. The device increases the likelihood of appropriate needle/tube placement and thus, decreases potential of iatrogenic injury.
Q: How does ThoraSite help reduce the overall procedure time?****
– A: ThoraSite reduces the time necessary to find proper anatomical landmark for thoracostomy placement and simplifies the cognative burden associated with thoracotomies.
Q: Is there a competitive product on the market?****
– A: Currently, SAM ThoraSite is the only landmark guide which aids in locating the procedure site for lateral thoracotomies and has no direct competitor.
Q: Is ThoraSite right or left-specific ?****
A: No, the single device design accommodates procedures on both the patient’s left and right side.
Q: Is ThoraSite Radiolucent?****
– A: Yes, ThoraSite is composed of materials compatible with X-ray imaging, eliminating the need for guide removal.
Q: How does SAM ThoraSite aid with identifying the procedure site?****
– A: The patented design references the patient’s own anatomical landmarks to position the Safe Zone Window directly over the ideal procedure site.
Q: How does SAM ThoraSite aid with accurate placement?****
– A: Despite differences in the patient’s general anatomy, ThoraSite accurately orientates the Safe Zone Window over their 3rd, 4th, and 5th intercostal spaces, the proper thoracostomy location.
Q: What body size range can ThoraSite be used on?****
– A: ThoraSite is designed to accommodate a large range of patient sizes. The device is intended for adult and adolescent use. It is not recommended for use in pediatric or neonatal patients.
Q: Can ThoraSite be reused.****
– A: No. ThoraSite is a single use device. Reuse of device may cause illness or injury.
Q: Can ThoraSite be used with an anterior or midclavicular approach?****
– A: No, ThoraSite is only indicated for lateral thoracostomies.
Q: What is ThoraSite’s Indication for Use?****
– A: ThoraSite is indicated for use by trained professionals following their standard of care to treat patients with pneumothorax, hemothorax, and similar conditions requiring a thoracostomy.
Q: What is ThoraSite’s Intended Use?****
– A: ThoraSite’s intended purpose and use is as an anatomical location aid to identify an appropriate location for lateral thoracostomies in adult and adolescent patients. Not intended for pediatric or neonatal use.
Q: Can SAM ThoraSite be folded without compromise?****
– A: SAM ThoraSite is designed to be flexible and adapt to patient anatomy while maintaining the Safe Zone Window spatial integrity. Although the device can fulfill its intended use even if the perforation is not intact, care should be taken during storage of ThoraSite not to damage the Perforated Release feature (which facilitates quick device removal).
Q: What environmental conditions can ThoraSite withstand and remain functional?****
– A: SAM ThoraSite was tested to endure a temperature exposure of 131°F (55°C) and can withstand being fully submerged in water for up to 10 minutes.
1,2 Shah, Amit Navin MD, MHSc; Kothera, Curt Steven PhD; Dheer, Sachin MD.
ThoraSite: A device to improve accuracy of lateral decompression needle and
chest tube placement. Journal of Trauma and Acute Care Surgery.
2019;87(1S):S128-S131.
Wernick B, Hon HH, Mubang RN, Cipriano A, Hughes R, Rankin DD, Evans DC,
Burfeind WR Jr, Hoey BA, Cipolla J, Galwankar SC, Papadimos TJ, Stawicki SP,
Firstenberg MS. Complications of needle thoracostomy: A comprehensive clinical
review. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):160-9
PRODUCT SPECIFICATIONS
SAM Medical Products ®
12200 SW Tualatin Rd., Ste 200
Tualatin, OR 97062 USA| MODELS AVAILABLE
SAM ThoraSite
5-PACK (TS200-5P-EN)
NSN 6515-01-694-8359
25-PACK (TS200-25P-EN)
---|---
PACKAGED SIZE (x1 DEVICE)
Height: 2.7 in (68.71 mm)
Width: 0.04 in (1.02 mm)
Length: 5.6 in (141.04 mm)
Weight: 0.18 oz (5.1 g)| GLOBAL SALES
sammedical.com
+1 503.639.5474
+1 800.818.4726 | U.S. Toll Free
US Patent Nº 10,595,898
SAM® is a registered trademark in the United States and other countries.
©2021 SAM Medical Products. All rights reserved.