Clinical Benefits; Indication For Use; Intended Use; Residual Risk - Hillrom The Twister Instructions D'utilisation

INSTRUCTIONS FOR USE
Replacement Straps
Uro catcher® System
Support Pole Pads
Name of Consumable
Easy Catcher® Disposable System
Uro Catcher Drapes
Brachytherapy Drapes for Uro Catcher
System
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.

Clinical Benefits:

2.4.1 Indication for use:

The Twister is used in a variety of surgical procedures including, but not limited to short
gynecology and urology surgery. These devices are capable of being used with a
broad patient population as determined appropriate by the caregiver or institution.

2.4.2 Intended use:

The Twister is designed to position and support the patient's foot, lower leg and upper
leg in a variety of surgical procedures including, but not limited to short gynecology
and urology surgery. These devices are intended to be used by healthcare
professionals within the Operating Room setting.

Residual Risk:

This product complies with relevant performance, safety standards. However,
device, user or patient harm from misuse, device damage, function or mechanical
hazards cannot be completely excluded.
Document Number: 80028135
Version: C
O-UC4 (US), O-UC4E (EU), O-UC4UK (UK),
O-UC4DEN (Denyer), O-UC4J (Japan)
Product Number
O-EC51, O-EC52
O-UC31, O-UC32
Page 12
O-CCPS
O-TSPP
A-50008
Issue Date: 06 MAR 2020
Ref Blank Template: 80025117 Ver. F