Setup & Operator Manual Compass Product Line
L610-0220 REV A
2
OVERVIEW
The device is intended for qualified medical personnel who have been trained in the use of medical
equipment.
Functional capabilities and operation of the equipment described herein can be employed in a variety of
diagnostic, therapeutic, and surgical applications.
Owner Responsibilities
The owner of this device is responsible to ensure system compatibility, the qualifications of the operator
and maintenance personnel. The operator must be properly trained and have obtained credentials from the
appropriate authorities.
The owner of this device is responsible for verifying continued compliance with all applicable regulations
and standards. Consult local, state, federal and/or international agencies regarding specific requirements
and regulations applicable to the use of this equipment.
Image Diagnostics, Inc. certifies only the equipment. After-sale operating practices and safety are the
responsibility of the owner and operator. Image Diagnostics, Inc. assumes no liability or responsibility for
after-sale operating or safety practices; nor can it be responsible for personal injury or damage resulting
from misuse.
Never make modifications or adjustments to the equipment unless directed by a qualified Image Diagnostics
representative. This equipment, when properly assembled, meets US federal regulations and standards.
Unauthorized modifications to the equipment may impact adherence to these standards and make the
equipment unsafe to operate.
Customer Support
Image Diagnostics will make available, on request, radiation testing results, component part lists, or other
information which will assist the user’s appropriately qualified technical personnel to repair those parts of
equipment which are designated by the manufacturer as repairable.
For technical assistance, call IDI at (978) 829-0009. Be prepared to give the complete model and serial
number found on Compass Product top pipe near vertical spring arm connection point at time of contact.
This Personnel Protective Shield component manufactured by Image Diagnostics, Inc. complies with
applicable FDA performance standards contained in 21CFR Sec. 892.6500 at date of manufacture.
Image Diagnostics, Inc.
310 Authority Drive
Fitchburg, MA 01420 USA
