Mobius AIRO Mobile CT System - Compatibility with Other Medical Devices and Software; Medical Devices; Medical Software; Accessories List

250 MI-42-0001 Rev. 19
ALLOWED EQUIPMENT: Compatibility with Other Medical Devices and Software
11.2 Compatibility with Other Medical Devices and
Software
11.2.1 Medical Devices
Accessories are
Marked
All components and accessories that can be removed in normal use are labeled on AIRO.
Information on the label includes a part number, model number, and the name or trademark of the
manufacturer to reference for obtaining replacements.
Other Medical
Devices
Using medical device combinations which have not been authorized by the
manufacturer may adversely affect safety and/or effectiveness of the devices and
endanger safety of patient, user and/or environment. Use of unauthorized devices is
improper use.
Brainlab Navigation
Systems
Brainlab Navigation Systems. Contact Brainlab for more information for proper connection and
operation with the AIRO System.
11.2.2 Medical Software
Authorization
Only authorized representatives may install software on the AIRO system. Do not
install or remove any software applications.
11.2.3 Accessories List
List of Allowed
Accessories
Allowed accessories include:
Accessory Mobius P/N
AIRO Switch Keys—two Gen1 keys MI-76-0161
AIRO Spare Keys—two Gen2 keys MI-76-0194
AIRO Key Tether MI-76-0248
Detachable 10-in. Pendant—one pendant MI-76-0237
Detachable 10-in. Pendants—two pendants MI-76-0238
Detachable 10-in Pendant Screen Protector MI-76-0244
Gantry Tilt Stopper MI-76-0218
Pendant-Cable Strain Relief MI-76-0240
QC Scan Phantom Platform MI-51-0094