List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH GE5402056 Manual Del Usuario

INSTRUCTIONS FOR USE

List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this
device.
Name of Accessory
Accessory Cart
Name of Consumable
Not Applicable
Note: Consult the corresponding IFU for the products mentioned in the above table.

Indication for use:

The vascular imaging product line is used for conditions observed during vascular
imaging that require surgical intervention. These devices are capable of being
used with a broad patient population as determined appropriate by the caregiver
or institution.

Intended use:

The vascular imaging product line is intended to be used in the Hybrid Operating
Room. This suite of accessories is used to convert the imaging surface of the table
to an operating table surface where other accessories required for the procedure
can be attached.

Residual risk:

This product complies with relevant performance, safety standards. However,
patient harm from misuse, device damage hazards cannot be completely
excluded.
Document Number: D-720649
Version: C
Product Number
Product Number
Not Applicable
Page 11
GE5402065
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E