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Universal Prepper 800-0161
Replacement Pad
Universal Prepper Pad 508-0159
INTENDED USE
Intended use is to hold the upper or lower extremities safely and effectively with its unique design allowing for infinite positioning of the extremity during prepping procedure. The intended users of this device are medical professionals within hospitals and surgery centers.
INSTRUCTIONS FOR USE
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 Universal Prepper to Surgical Table
- Attach Schure Socket XL P/N 800-0134 (sold separately) to side rail
- Insert mounting post into socket - locking tight
- Unlock horseshoe cradle and move to desired position, turn handle to lock
Detaching Universal Prepper from Surgical Table
- Turn clamp handle counterclockwise to loosen and remove
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 36.5” +/- 0.5” (93 cm +/- 1 cm)
- Width: 11” +/- 0.5” (28 cm +/- 1 cm)
- Depth: 4” +/- 0.5” (25 cm +/- 1 cm)
- Device Weight: 5 lbs. +/- 0.5 lbs. (2 +/- .22 kg)
- 5/8” (1.6 cm) diameter mounting post insert into socket
- Single-person installation
- Twist lock/Release Handle
COMPONENT OVERVIEW
Universal Prepper is a surgical table accessory that holds upper or lower extremities safely and effectively. Unique pivoting design allows for infinite positioning of extremity.
Other required product for use:
800-0134 Schure Socket XL (sold separately)
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0134
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0134-DEN
Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0134-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0134-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0134-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0134-SWISS
Replacement Pad: Universal Prepper Pad 508-0159
GENERAL INFORMATION
- Product not made with (NRL) 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 (RMA) 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)
DISPOSAL
- 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
PRODUCT USE WARNINGS
WARNING! Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
WARNING! Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
WARNING!
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
WARNING! Surgical table load capacities may be less. Never overload a surgical table. Device is intended for mounting on side rail of surgical table only.
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
WARNING!
Adhere to standards for blood-borne pathogens from Occupational Safety and Health Administration (OSHA). Use recommended protective clothing, gloves, masks and eye protection to clean accessory.
CAUTION
Strictly read/follow manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.
- Remove major contaminants from accessory with disposable materials. Follow appropriate bio-hazard waste disposal procedures.
- Apply cleaning fluid liberally to entire accessory and wipe with clean, lint-free cloth until all moisture and cleaning fluid is removed from accessory
- Let accessory dry
USER NOTICE
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.
IFU-800-0161 REV 3.06
Basic UDI-DI: 081001460F0002DL
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
Symbol Glossary
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