Mobius AIRO Mobile CT System - Pediatric Use Summary

6 MI-42-0001 Rev. 19
GENERAL INFORMATION: AIRO Mobile CT System
Intended Location AIRO is to be used only in areas that the responsible organization has designated and declared
suitable for safe operation.
Place of Control AIRO is controlled inside the treatmen
t room during scan mode. For scanning purposes, AIRO is not
intended to be controlled from outside the treatment room. The operator of the equipment needs to
have a direct and clear line of sight to the device and to the patient when in use and when moving
the equipment.
Tolerance to Water The moisture tolerance of the device is component dependent. Nothing more wet than a wrung out
drip-les
s towel should be used anywhere near the device. The column is rated IPX4. Overall system
is IPX0.
Improper Use
Improper use is defined as using AIRO or any part of AIRO in any way inconsistent
with the methods and precautions described in this manual, or with the methods
described in authorized training, or use by anyone who is not properly trained and
medically qualified.
1.4.2 Pediatric Use Summary
Overview Exercise special care when imaging patients with physiques that fall outside the typical adult size
range. This applies especially to smaller pediatric patients whose size does not overlap the adult
size range (e.g., patients less than 50 kg (110 lb) in weight and 150 cm (59 in) in height,
measurements which approximately correspond to those of an average 12 year old or a 5th
percentile U.S. adult female.)
Exposure to ionizing radiation is of particular concern for pediatric patients because:
• For certain organs and tumor types, younger patients are more radio-sensitive than adults. As a
result, the cancer risk per unit dose of ionizing radiation is typically higher for younger patients.
• Use of AIRO with Protocols and exposure settings designed for adults can result in excessive
and unnecessary radiation exposure of smaller patients.
• Younger patients have a longer expected lifetime over which the effects of radiation exposure
may manifest as cancer.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA (As Low As
Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary
to obtain images that are clinically adequate.
Reference for
Pediatric Do
se
Optimization
The
following resource provides information about pediatric and general imaging radiation safety for
AIRO systems:
• MI-42-0005 AIRO Application Guide Protocols and Principles