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Major Procedure Table w/Leg, Phenolic 800-0026-MJ-P
Major Procedure Table w/Leg, Carbon Fiber 800-0026-MJ-CF
Major Procedure Table Deluxe Pad 508-0073
Device Initial Release: 9/8/2012
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
Become familiar with the features of patient positioning device before use with a patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
Attaching Procedure Table to Surgical Table
- Attach clamps (sold separately) to side rails and place them approximately 1' (31 cm) apart (as shown)
- Insert mounting rods into clamps
- Adjust procedure table so that it is level with surgical table pad. Secure table to accessory rail using clamp locking knobs
- Includes 1" (3 cm) pressure management pad
- Clamps sold separately
Adjusting Table Leg
(1) End Rail • (2) Adjustable Swivel Leg Locking Handle • (3) Adjustable Height Locking Handle
- Swivel leg in 360° to obtain unlimited C-arm axis (see above)
- Loosen Adjustable Leg Handle (3) and extend leg until it sits firmly against ground then lock handle tight by turning it to the right
- End rail accommodates traction attachments
Its function is to provide a stable platform for all arm and hand surgeries.
Device Dimensions (maximum)
- Length: 34” +/- 0.5” (86 cm +/- 1 cm)
- Width: 15” +/- 0.5” (38 cm +/- 1 cm)
- Depth: 42” +/- 0.5” (107 cm +/- 1 cm)
- Phenolic Device Weight: 15 +/- 0.5 lbs. (6.8 +/- .22 kg)
- Carbon Fiber Device Weight: 10 +/- 0.5 lbs. (4.5 +/- .22 kg)
- Attaches to surgical table anywhere on the rail using two rail clamps
- Single-person installation
- Clean with hospital grade disinfectant
Major Procedure Tables, w/Leg, Phenolic or Carbon Fiber, are surgical table extensions that attach to all rails.
Two Clamps Required: Choose Universal Clamp for US or Deluxe Rail Clamp for Outside US
508-0073 Major Procedure Table Deluxe Pad
US – Universal Rail Clamp
Outside US – Deluxe Rail Clamp
- US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0085
- Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0248-DEN
- Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0248-EU
- Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0248-UK
- Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0248-JPN
- Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0248-SWISS
- 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
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.
Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
Strictly read/follow manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
- 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-800-0026-MJ-P-CF REV 3.04
Basic UDI-DI: Phenolic Model – 081005737F0022KP
Basic UDI-DI: Carbon Fiber Model – 081005737F0023KR
Latest Revision: 9/15/2021