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Universal Prepper 800-0161
Universal Prepper Pad 508-0159
Device Initial Release: 12/29/2011
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | email@example.com
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands
INSTRUCTIONS FOR USE
Attaching Universal Prepper to Surgical Table
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.
Detaching Universal Prepper from 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
- Turn clamp handle counterclockwise to loosen and remove
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.
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
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
- 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)
- 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! Surgical table load capacities may be less. Never overload a surgical table. Device is intended for mounting on side rail of surgical table only.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
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.
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
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 3.05
Basic UDI-DI: 081001460F0002DL
Latest Revision: 7/28/2021