Augustine Surgical WaffleGrip A301 Instructions For Use

A301 WaffleGrip® Trendelenburg
Positioning + BackSaver® Slide
Sheet Kit, 10-Pack
Instructions for Use
Device Description
The WaffleGrip Trendelenburg Positioning System uses friction to securely hold a patient in steep Trendelenburg position
and must be used with a HotDog Warming Mattress. It also allows heat from the HotDog Warming Mattress to reach the
patient, if the Mattress is set to warm.
WaffleGrip is single-use and must be discarded following completion of the surgical procedure.
Indications for Use
WaffleGrip is a single-use device to secure the patient on the table during surgical procedures utilizing the steep
Trendelenburg position while also accommodating underbody warming. WaffleGrip is intended to be used by healthcare
professionals in accordance with these instructions for use. The use environment is a professional healthcare facility.
Target Patient Groups
The patient population is adult patients for whom the steep Trendelenburg position is determined to be necessary by the
healthcare professionals. There is no weight limit.
Intended Use
WaffleGrip is intended to position and secure patients in the steep Trendelenburg position during surgical procedures.
Contraindications

None
Warnings

Ensure that the patient's skin is in direct contact with the WaffleGrip surface throughout the procedure.

Do not use lubricants, oils, or powders on the patient's skin in contact with WaffleGrip. If necessary, clean skin
with alcohol before use. A decrease in friction will reduce securement capability and could result in unintended
patient movement.

Not designed for use in reverse Trendelenburg.

Do not use at a Trendelenburg angle greater than 45°.

California Proposition 65 Warning: The medical devices and products mentioned in this IFU may contain chemicals
including Urethane, which is known to the State of California to cause cancer, birth defects, or other reproductive
harm. For more information go to, www.p65warnings.ca.gov
Precautions

A waffle pattern may be temporarily visible on skin, but it will dissipate shortly following the procedure.

Ensure the WaffleGrip remains flat under the patient. If it is rolled or folded, flatten before proceeding.

Do not tilt the OR table until the BackSaver Slide Sheet has been removed.

Ensure that the U300 HotDog Trendelenburg Warming Mattress is securely strapped to the table before placing
the WaffleGrip kit. Refer to the HotDog Warming Mattress IFU for details.

This device should not be disposed of with general waste at end of life. Follow local regulations for disposal. The
device does not pose any potential hazard.
1
A301 contains 10 kits (10 uses)
Each kit contains:
1 BackSaver Slide Sheet
1 WaffleGrip Anti-Slip Layer
1
WaffleGrip Draw
Sheet