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Instructions for Use
Bi-Lateral Prepper 800-0236
Replacement Pad
Universal Prepper Pad 508-0159
INTENDED USE
Intended use is to hold lower extremities during
prepping procedure. The intended users of this device
are medical professionals within hospitals and surgery
centers.
GENERAL INFORMATION
• Product not made with Natural Rubber Latex
• Device supports 500 lb. (227 kg) proportional patient load (6'4" (193 cm) tall patient per 99% human
body model)
• Product warranty covers product from manufacturing defects for period of 2 years
• If damaged in shipping, call Customer Service at (888) 724-8763 or (781) 982-7000 to obtain Return
Material Authorization number. For product warranty issues, contact Customer Service.
• CE marked medical device according to MDR (EU) 2017/745
• Product is maintenance-free, check product condition before next use
• Life of device is 5 years under normal use
• Store device between -4°F to +86°F (-20°C to 30°C)
INSTRUCTIONS
Become familiar with patient positioning device's features before use with patient. Always practice on a
nurse, physician or appropriate volunteer prior to using clinically.
Attaching Bi-Lateral Prepper to Surgical Table
1. Attach Schure Socket XL P/N 800-0134 (sold separately) onto side rail
2. Insert mounting post into socket and lock tight
3. Unlock horseshoe cradles by turning handles counterclockwise and move to desired positions, turn
handle clockwise to lock
Detaching Bi-Lateral Prepper from Surgical Table
1. Turn clamp handle counterclockwise to loosen and remove
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
• Length: 19" +/- 0.5" (48 cm +/- 1 cm) (between stops)
• Height: 34" +/- 0.5" (86 cm +/- 1 cm)
IFU-800-0236 REV 3.06
Latest Revision: 2022-01
1
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Summary of Contents for SchureMed 800-0236
- Page 1 Instructions for Use Bi-Lateral Prepper 800-0236 Replacement Pad Universal Prepper Pad 508-0159 INTENDED USE Intended use is to hold lower extremities during prepping procedure. The intended users of this device are medical professionals within hospitals and surgery centers. GENERAL INFORMATION •...
- Page 2 • General - Prevent infection by cleaning and disinfecting product before disposal • Packaging - Dispose packaging material via household waste according to national requirements • SchureMed accepts back used or retired products - or dispose of product in accordance with national requirements...
- Page 3 Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Basic UDI-DI: 081001460F0069EL eIFU Language Versions To download and print the Instructions for Use, please go to http://www.schuremed.com/schuremed-eifu. Symbol Glossary Symbol Title...
- Page 4 Manufacturer SchureMed (081001460) 452 Randolph Street, Abington, MA 02351 USA Toll Free (888) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | orders@schuremed.com Authorized Representative Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands IFU-800-0236 REV 3.06 Latest Revision: 2022-01 ...
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