Clinical Benefits; Indication For Use; Intended Use; Residual Risk - Hillrom Little PAL Instrucciones De Uso

INSTRUCTIONS FOR USE
Shoulder Supports
Uro catcher
Stirrup cart
Name of Consumable
Easy Catcher® Disposable System
Uro Catcher Drapes
Brachytherapy Drapes for Uro Catcher
System
Allen Safety Drape
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.

2.4 Clinical Benefits:

2.4.1 Indication for use:

The Pediatric Stirrup is used in a variety of surgical procedures including, but not
limited to gynecology, urology, laparoscopy, general and robotic surgery. These
devices are appropriate for most pediatric patients ages 3-6, as determined
appropriate by the caregiver or institution.

2.4.2 Intended use:

The Pediatric Stirrup 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
gynecology, urology, laparoscopy, general and robotic surgery. These devices are
intended to be used by healthcare professionals within the Operating Room setting.

2.5 Residual Risk:

This product complies with relevant performance, safety standards. However,
patient harm from misuse, device, function or mechanical hazards cannot be
completely excluded.
Document Number: D-720613
Version: C
System
®
Page 12
A-63500
O-UC4 (US), O-UC4E (EU), O-UC4UK (UK),
O-UC4DEN (Denyer), O-UC4J (Japan)
A-30015
Product Number
O-EC51, O-EC52
O-UC31, O-UC32
A-80008
A-22000
Ref Blank Template: 80025117 Ver. F
Issue Date: 10 MAR 2020