Simple Clamp

Download IFU pdf 

  Simple Clamp   800-0228   
  Simple Clamp (EU)   800-0228-EU
  Simple Clamp (UK)   800-0228-UK 
  Simple Clamp (DEN)   800-0228-DEN
  Simple Clamp (JPN)   800-0228-JPN 
  Simple Clamp (SWISS)   800-0228-SWISS

INTENDED USE
Intended use is to hold surgical accessories with 1" x 3/8" (2.5 cm x .95 cm) flat mounting post vertically anywhere along table side rail or a 1" x 1/4" (2.5 cm x .64 cm) horizontally mounting blades. 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.

1. Snap Simple Clamp on surgical table side rail
2. Place flat bar of accessory into mounting hole
3. Secure clamp by turning handle clockwise to lock position

1. Unlock clamp by turning the handle counterclockwise and remove mounting bar
2. Lift simple clamp off surgical table side rail

• Length: 3” +/- 0.5” (8 cm +/- 1 cm)
  
• Width: 1.75” +/- 0.5” (4 cm +/- 1 cm)
• Depth: 1.375”+/-  0.5” (4 cm +/- 1 cm)
• Device Weight: 1 +/-  0.5 lbs. (.45 kg +/- .22 kg)
• Attaches to rail of a surgical table at any point on rail
• Single person installation
• Holds accessory equipment with 1” x 3/8” (2.5 cm x .95 cm) flat mounting posts

COMPONENT OVERVIEW
Simple Clamp is a surgical table clamp that attaches to all rails. Its function is to hold surgical accessories on a surgical table.

See side rail dimensions below:
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0228   
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0228-DEN 
Europe: 0.394” x 0.984” (10 mm x 25 mm )  PN# 800-0228-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0228-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0228-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0228-SWISS

• Product not made with (NRL) Natural Rubber Latex
• Device supports 720 lb. (327 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 720 lbs. (327 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 for your Operating Table system. 

WARNING! 
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.

CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.


WARNING!
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.

1. Remove major contaminants from accessory with disposable materials. Follow appropriate bio-hazard waste disposal procedures.
2. Apply cleaning fluid liberally to entire accessory and wipe with clean, lint-free cloth until all moisture and cleaning fluid is removed from accessory
3. 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-800-0228  REV 3.05

  Basic UDI-DI: 081001460F0051DZ

Latest Revision: 2022-01

eIFU Language Versions
To download and print the Instructions for Use, please click here.

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