Tested in accordance with ASTM and IEC standards, ScatterGuard Disposable Smart Caps provide head protection for fluoro-lab and operating suite personnel during interventional procedures. They are sterile, one-size-sits-all and disposable through normal waste procedures.
Disposable Smart Cap Characteristics
Core Material:Prolite
Protection Options:0.125mm, 0.25mm, 0.375mm LE
Fabric:Blue SMS
Shelf Life:Non-sterile and Sterile – 3 years after MFG dat
Quantity:20 caps per box
Sizing:One size fits all
CE Marked:Yes (only applies to 0.25mm LE)
Certifications:Certified to ASTM F3094-14 and IEC 61331-1:2014 standards.
Cap Compliance
Intended Use:Scatterguard Smart Caps are specially designed for fluoroscopic procedures to reduce scatter radiation dose to the wearer. The Cap is to be used in addition to and not place of standard radiation protective devices. Scatterguard Smart Caps are ideal where the user needs protection from ionizing radiation during various types of procedures such as General X-Ray & Fluoroscopy, Radiography, Neuroradiology, Urology, MRI, CT, Radiotherapy and Nuclear Medicine.
Compliance Requirements:ASTMF 2547-18; IEC 61331-1:2014 Biocompatibility Compliance:ISO 10993, ASTM F 719 and ASTM F 720
Storage, Disposal and Expiration
Storage:Store caps in a cool, dry and ozone-free place (below 35°C). Keep out of direct sunlight. Caps should remain in their original packaging until use. Care should be taken to avoid sharp objects as punctures will allow radiation to pass.
Disposal:Scatterguard Caps should be disposed of through normal waste procedures in accordance with local laws and regulations. The material should not be disposed of by incineration and use of self-contained breathing apparatus is recommended if the sheeting is ignited by fire.
Expiration:The shelf life of a sterile and non-sterile cap is 3 years from manufactured date per FDA requirement. This indication may be found on the label on the original external packaging and indicates the period of time during which the device, sterilized with radiation or Ethylene Oxide, may be used as long as it has been stored properly in suitable conditions and has intact packaging.