Regulation 32

the name and address of the manufacturer;

the name and address of the distributor, if the distributor is not the manufacturer;

the type and model designation;

the serial number;

the month and year of manufacture;

the static magnetic field strength in Tesla (T); and

the line voltage used for normal operation.

a contraindications section stating that —

the apparatus is contraindicated for patients who have electrically, magnetically or mechanically activated implants; and

scanning patients with intracranial aneurysm clips is contraindicated unless the physician is certain that the clip is not magnetically active;

a warning statement, warning of —

the risk of scanning patients with implanted surgical clips or other ferromagnetic materials or engaged in occupations or activities which may cause ferromagnetic metal implants;

the risk of scanning fetuses and infants;

the risk to patients and other persons that might result from the inadvertent introduction of ferromagnetic materials into proximity with the magnet, along with a recommendation advising the user to establish a security zone to prevent such a risk;

the risk to persons with cardiac pacemakers or other implanted devices who enter a zone where the magnetic field exceeds 5 gauss;

the risk to decompensated cardiac patients, febrile patients and patients with impaired ability to perspire;

the risk of scanning patients with permanent eye-liner tattoo or who are wearing facial make-up which may contain ferromagnetic particles;

the risk of scanning patients suspected of having embedded conductive or magnetically active fragments in or near the eye; and

in the case of a superconducting magnet system, the risk of asphyxiation related to quench, along with a recommendation that the magnet room be designed to vent gases directly to the outside; and

a precaution concerning the scanning of patients —

who have a greater than normal potential for cardiac arrest;

who are likely to develop seizures or claustrophobic reactions; or

who are unconscious, heavily sedated or confused and with whom no reliable communication can be maintained.

a description of the recommended training needed by the physician and the operator to operate the apparatus safely and effectively;

a recommendation to the user to establish an appropriate plan and an emergency procedure for removing and treating any person, who requires emergency assistance, rapidly from the magnet’s influence;

a description of quality assurance procedures recommended for the user including a detailed specification of all phantoms to be used;

recommended maintenance schedules, including designation of whether the user or company service personnel should perform them; and

device specifications from the summary specification sheet with ranges where applicable.