TM-GL Installation and User Guide, December 2019
Reina Imaging
6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918
Page 3 of 15
i. Intended Use
The TM-GL Mobile Trans-Former (Model# TM-GL) is designed to hold and position the
D-EVO GL Long-Length DR Panel for use in general radiography.
ii. Safety and Compliance
Precautions!
•
The unit is pre-assembled but take care in uncrating, as the device is very heavy.
•
Follow any warning labels on the unit and these instructions.
•
Do not attempt to adjust the Detector Mount height prior to reading the
instructions.
•
Failure to adhere to the Precautions listed herein may result in injury to user or
patient!
Compliance
The
TM-GL Mobile Trans-Former
is a Class 1 Medical Device (510k exempt) in the USA
and is registered to:
Reina Imaging
6107 W. Lou Avenue
Crystal Lake, IL 60014 USA
Phone: 800-752-4918
The
TM-GL Mobile Trans-Former
has been labeled and declared:
This model has been classified as a Class 1, Annex VII device.
European Authorized Representative:
Pinchet Rx SRL
Contact: Paolo Pinchet
Via Don Gnocchi 24 20148 Milano Italy
Phone: 02 / 48707603