WaffleGrip A301 Trendelenburg Positioning + BackSaver Slide Sheet Kit Instruction Manual
- July 23, 2024
- WaffleGrip
Table of Contents
WaffleGrip A301 Trendelenburg Positioning + BackSaver Slide Sheet Kit
Specifications
- Contains 10 kits with each kit having 1 BackSaver Slide Sheet, 1 WaffleGrip Anti-Slip Layer, and 1 WaffleGrip Draw Sheet
- Intended for single-use only
- Designed for securing patients in steep Trendelenburg positions during surgical procedures
- No weight limit is specified for the patient population
Product Usage Instructions
Device Description
The WaffleGrip Trendelenburg Positioning System is used to securely hold a patient in a steep Trendelenburg position. It must be used with a HotDog Warming Mattress to allow heat transfer to the patient.
Indications for Use
WaffleGrip is intended for use by healthcare professionals to secure patients on the table during surgical procedures in steep Trendelenburg position while facilitating underbody warming.
Target Patient Groups
Adult patients require steep Trendelenburg positions as determined by healthcare professionals. No weight limit is specified.
Intended Use
Position and secure patients in steep Trendelenburg positions during surgical procedures.
Warnings
- Ensure the patient’s skin is in direct contact with the WaffleGrip surface
- Avoid using lubricants, oils, or powders on the patient’s skin in contact with WaffleGrip
- Clean skin if necessary
Precautions
- Ensure WaffleGrip remains flat under the patient
- Do not tilt the OR table until the BackSaver Slide Sheet is removed
- Securely strap the U300 HotDog Trendelenburg Warming Mattress before placing the WaffleGrip kit
- Dispose of the device according to local regulations
Set-up and Use
- Secure U300 HotDog Trendelenburg Warming Mattress to the Operating Table
- Place U300 Mattress on operating table with the sensor and cable toward the head end
- Align the perineal cutout on the warming mattress with that of the operating table
- Attach mattress to side rails using at least 4 straps
- Align and Secure WaffleGrip Positioning System
- Place the folded A301 Kit on the HotDog warming mattress and unfold the non-slip WaffleGrip layer
- Align sealed lines on WaffleGrip with the edges of the warming mattress
- Feed mattress cable through pad porthole and fold excess WaffleGrip material under U300 mattress
- Tuck reinforced plastic flap between U300 and operating table at the perineal end
FAQ
- Q: Is there a weight limit for patients using the WaffleGrip Positioning System?
- A: There is no weight limit specified for the patient population using the WaffleGrip system.
- Q: Can the WaffleGrip be reused?
- A: No, the WaffleGrip is intended for single use only and must be discarded following the completion of the surgical procedure.
- Q: What should be done if a waffle pattern is visible on the patient’s skin after the procedure?
- A: The waffle pattern may be temporarily visible on the skin but is not a cause for concern and will dissipate shortly after the=] procedure.
A301 contains 10 kits (10 uses)
Each kit contains:
- 1 BackSaver Slide Sheet
- 1 WaffleGrip Anti-Slip Layer
- 1 WaffleGrip Draw Sheet
Instructions for Use
Device Description
The WaffleGrip Trendelenburg Positioning System uses friction to securely hold
a patient in a 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 comprised of adult patients for whom the steep Trendelenburg position is determined to be necessary by 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 the 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
Precautions
- A waffle pattern may be temporarily visible on skin but it is not a cause for concern and will dissipate shortly following the procedure.
- Ensure the WaffleGrip remains flat under the patient. If it is rolled or folded, flatten it 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.
- Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the country in which it occurred.
Set-up and Use
Secure U300 HotDog Trendelenburg Warming Mattress to the Operating Table
- Place U300 Mattress on the operating table with the sensor and cable toward the head end.
- Align the perineal cutout on the warming mattress with that of the operating table.
- Attach mattress to side rails using at least 4 straps, as shown.
Align and Secure WaffleGrip Positioning System.
- Place the folded A301 Kit on the HotDog warming mattress as shown on the label and unfold the non-slip WaffleGrip layer.
- The sealed lines on WaffleGrip should be aligned with the edges of the warming mattress.
- Feed mattress cable through pad porthole and fold excess WaffleGrip material under U300 mattress.
- IMPORTANT— at the perineal end, Tuck reinforced plastic flap between U300 and the operating table mattress [see cross-section 2d]. The flap should not be visible or hanging amongst perineal cutouts. Tuck the remaining WaffleGrip layer (beyond fold lines) under a warming mattress.
- Ensure that the perineal drape (2e), the plastic material at the perineal end, is draped and hanging over the perineal cut-out to prevent fluids from leaking under the warming mattress. IMPORTANT: if the plastic is under the patient, it prevents WaffleGrip from performing and the patient could move in Trendelenburg
Align and position the BackSaver™ Slide Sheet
- Unfold the yellow BackSaver Slide Sheet over the WaffleGrip layer.
- Tuck the head-end of the BackSaver Slide Sheet under the Warming Mattress.
- Ensure that the pull tabs are hanging off the side of the operating table for easy removal.
- Position the draw sheet in the center of the Warming Mattress with the grip side facing up.
Initiate Patient Warming
- Connect the U300 Warming Mattress to the HotDog Controller using A112 blue cable. Select temperature and start warming.
- See Warming Mattress IFU (2064EU) for instructions on operating a HotDog patient warming mattress
Maneuver and Position the Patient
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During prep, the patient should lie on top of the Slide Sheet and draw sheet.
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To reposition the patient, one person on each side of the table must hold the draw sheet securely with two hands.
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After induction, to reposition the patient lower on the table, use the draw sheet to slightly raise the patient from the table while moving the patient down the table over the Slide Sheet. Follow institutional protocols for supporting the legs, head and neck.
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Once the patient is properly positioned for lithotomy, place draw sheet ends over the patient for Slide Sheet removal.
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REMOVE the Slide sheet by pulling on the two tabs at the head end. Be sure to completely remove the Slide Sheet, which will tear down the perforation in the middle.
IMPORTANT —The slide Sheet must be removed prior to tilting the table or serious injury may result. -
Check the draw sheet to ensure it remains flat under the patient.
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Secure arms with the draw sheet as shown or per hospital positioning protocol.
- Align the ends of the draw sheet between the patient’s torso and arm, then wrap the arms to secure.
- Tuck excess material between the U300 Warming Mattress and operating table mattress to hold it in place.
IMPORTANT – The patient must be in direct skin contact with WaffleGrip to prevent slipping in Trendelenburg.
- Optional: You can also use a B500 HotDog Universal Warming Blanket folded across the patient’s chest. Use a hospital-provided strap to secure the blanket. Strap not included.
- See separate instructions for HotDog Patient Warming Blankets
USE ONLY AS INDICATED
Reminder: A waffle pattern may be temporarily visible on the skin but it is
not a cause for concern and will dissipate shortly following procedure.
Definition of Symbols
CONTACT
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Phone: +1-952-465-3500
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Email: CS@AugSurg.com
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HotDog is a trademark of Augustine Temperature Management, registered in the U.S. Patent & Trademark Office. Devices are protected by some or\ all of the following patents:
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(US Patents 10, 575,784; 10,765,580; 10,959,675; 10,980,694; 10,993,866; 11,103,188). Other patents are pending.
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Augustine Temperature Management, LLC 15305 Minnetonka Blvd., Minnetonka, MN 55345
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Tel: 952-465-3500
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EMERGO EUROPE B V
Westervoortsedijk 60 6827 AT Arnhem, The Netherlands -
MedEnvoy Global BV
Prinses Margrietplantsoen 33 – Suite 123, 2595 AM, The Hague, The Netherlands
© 2024 Augustine Surgical, Inc. All rights reserved.
References
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