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Hourglass Procedure Table w/Leg, Phenolic 800-0026-HG-P
Hourglass Procedure Table w/Leg, Carbon Fiber 800-0026-HG-CF
Replacement Pad
Hourglass Procedure Table Deluxe Pad 508-0106
INTENDED USE
Its function is to hold a patient’s arm during surgery. The intended users of this device are medical professionals within hospitals and surgery centers.
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 floor then lock handle tight by turning it to the right
- End rail accommodates traction attachments
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 32” +/- 0.5” (81 cm +/- 1 cm)
- Width: 15” +/- 0.5” Middle (38 cm +/- 1 cm)
- Width: 23” +/-0.5” Ends (58 cm +/- 1 cm)
- Depth: 23” +/- 0.5” (58 cm +/- 1 cm)
- Phenolic Device Weight: 18 +/- 0.5 lbs. (8.1 +/- .22 kg)
- Carbon Fiber Device Weight: 15 +/- 0.5 lbs. (6.8 +/- .22 kg)
- Attaches to rail of surgical table at any point on the rail using two rail clamps
- Single-person installation
- Clean with hospital grade disinfectant
COMPONENT OVERVIEW
Hourglass Procedure Table, w/Leg,
Phenolic or Carbon Fiber, are surgical table extensions that attach to all rails.
Replacement Pad
508-0106 Hourglass Procedure Table Deluxe Pad
Two Clamps Required: Choose Universal Clamp for US or Deluxe Rail Clamp for Outside US
US – Universal Rail Clamp
- US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0085
Outside US – Deluxe Rail Clamp
- 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
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!
Hazard resulting 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!
Adhere to standards for blood-borne pathogens from the Occupational Safety and Health Administration. Use recommended protective clothing, gloves, masks and eye protection to clean accessory
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
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-800-0026-HG-P-CF REV 3.04
Basic UDI-DI: Phenolic Model – 081005737F0022KP
Basic UDI-DI: Carbon Fiber Model – 081005737F0023KR
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