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Universal Rail Clamp 800-0085
INSTRUCTIONS FOR USE
Intended use is to hold surgical accessories on surgical table. The intended users of this device are medical professionals within hospitals and surgery centers.
Become familiar with patient positioning device’s features before use with patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
Universal Rail Clamp is spring-loaded - attaches anywhere along surgical table side rail. Attaches to all surgical table side rails that are 3/8”W x 1-1/8”H (.95 cm x 3 cm). Clamp accepts any round mounting posts up to 5/8” (1.6 cm) in diameter and rectangular mounting posts up to 1” x 3/8” (2.5 cm x .95 cm).
Attaching to Side Rail
Detaching from Side Rail
- Attach clamp on rail
- Turn clamp handle clockwise to lock securely
Device Dimensions (maximum)
- Turn clamp handle counter-clockwise to unlock and remove from rail
- Length: 3” +/- 0.5” (8 cm +/- 1 cm) (Handle Collapsed),
5.5” +/- 0.5” (14 cm +/- 1 cm) (Handle Extended)
- Width: 2”+/- 0.5” (5 cm +/- 1 cm)
- Depth: 4” +/- 0.5” (10 cm +/- 1 cm)
- Device Weight: 1 +/- 0.5 lbs. (.45 kg +/- .22 kg)
- Attaches to rail of surgical table at any point on rail
- Single-person installation
- Holds accessory equipment up to 5/8” (1.6 cm) diameter and 1” x 3/8” (2.5 cm x .95 cm) flat mounting post
Universal Rail Clamp is a surgical table clamp attaching to all U.S. rails. Its function is to hold surgical accessories on a surgical table.
Side rail dimensions below:
US: 0.374” x 1.122” (9.5 mm x 28.5 mm)
- Product not made with (NRL) Natural Rubber Latex
- Device supports 350 lb. (159 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 350 lbs. (159 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
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.
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.
- 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.
IFIFU-800-0085 REV 3.06
Basic UDI-DI: 081005737F0017KW
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
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Fax (781) 982-7001 | firstname.lastname@example.org
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