Swoop™ Portable MR Imaging
2Pages

Site Readiness Checklist • Designate a location where the Scanner is to enter the building. • Designate a transport path from the building entry to the Scanner storage location. • Designate drivers for the Scanner who are screened to be safe in an MRI environment (See Contraindications and Patient and Operator Screening). • Designate operators for the Scanner who are screened to be safe in an MRI environment (See Contraindications and Patient and Operator Screening). • Designate assistants to support placing patients into the Scanner and who are screened to be safe in an MRI environment (see Positioning the Patient). • Complete safety training for Scanner drivers – approved by Hyperfine. • Complete safety training for Scanner operators – approved by Hyperfine. • Designate a storage location for the Scanner that has the following properties: • 158 cm (62 inches) diameter of floor space or an equivalent boundary to contain the 5 Gauss line within a Controlled Access Area. Controlled access to protect entrance by the general public (e.g., locked door and/or barricades). Available standard power outlet to keep the PowerAssist battery charged. Signs indicating the presence of a magnetic field within the storage area. • Designate transportation paths from the Scanner storage location to patient location where you will perform imaging exams using the Scanner. • Define a plan for controlled access (e.g., using signs, using the Gauss Guard, barricades, lockable doors at the location) for scanning the patient. • Define a plan for protecting the 5 Gauss line from the unscreened general public during transportation, using for example: • The Scanner’s built-in Gauss Guard. • Flag people accompanying the Scanner driver. • Temporary pathway closures to separate the un

• Define a procedure for screening patients for MRI safety who you will image with the Scanner (See Contraindications and Patient and Operator Screening). • Define policies and procedures to allow (or disallow) family members to stay in the area during scanning. This may require MRI safety screening if family members are allowed to cross the 5 Gauss boundary. • Define an approach for network connectivity (Hyperfine’s Manufacturer Disclosure Statement for Medical Device Security MDS2 is available upon request) approved by your site’s IT and Network Security groups, including approved options...