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Wrist Tower 800-0135
Device Initial Release: 7/2/2009
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | firstname.lastname@example.org
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.
790-0016: SchureHand Positioner • 790-0037: Counter Traction • 790-0036: Hand Support
790-0011: Lower Control Tube • 790-0014: Traction Support Bar • 790-0015: Traction System
*Drape the Table Prior To Doing this Procedure
- Attach CamLoc Clamp over drapes where there are no notches on side rail
- Insert Lower Control Tube 790-0011 and it lock into clamp
- Attach Counter Traction 790-0037
- Attach Hand Support 790-0036
- Attach Traction Support Bar 790-0014. Lock handle down tight.
- Plug in 790-0015 Traction System
- Attach SchureHand Positioner 790-0016
INSTRUCTIONS FOR USE
- Insert (512-0015) finger traps into appropriate slot of (790-0016)
- Adjust desired height of Counter Traction (790-0037) by unlocking handle, once at desired height, lock handle tight
- Adjust desired height of Hand Support (790-0036) by unlocking handle, once at desired height lock handle tight
- Adjust height of (790-0014) by unlocking handle, once at desired height, lock handle tight
- Insert appropriate fingers into finger traps (512-0015)
- To adjust traction, turn knob right to tighten and left to loosen
- Remove SchureHand Positioner 790-0016 by pulling the plunger with one hand and using your other hand to remove SchureHand Positioner
- Loosen handle, unplug the Traction System 790-0015
- Unlock handle, remove Traction Support Bar 790-0014
- Unlock handle; remove Hand Support 790-0036
- Unlock handle remove Counter Traction 790-0037
- Loosen star knob on clamps, remove Lower Control Tube 790-0011
- Unlock clamp remove from side rail
Intended use is to provide traction and intra-operative positioning controlled by surgeon's preference during wrist surgery.
Device Dimensions (maximum)
- Length: 14” +/- 0.5” (36 cm +/- 1 cm)
- Depth: 360° Rotation
- Height: 53” +/- 0.5” (135 cm +/- 1 cm) (extended), 34”+/- 0.5” (86 cm +/- 1 cm) (collapsed)
- Device Weight: 9.50 +/- 0.5 lbs. (4.3 +/- .22 kg)
- Attaches to the rail of a surgical table using the CamLoc Clamp (sold separately) at any point on the rail
- Single-person installation
Wrist Tower is a device used during wrist surgery. Its function is to provide traction and intra-operative positioning controlled by surgeon's preference, during supine elbow surgery. A CamLoc Clamp (sold separately) is required to attach Wrist Tower to surgical table.
- US: 0.375” x 1.125” (9.5 mm x 28.5 mm) PN# 800-0271
- Denyer: 0.242” x 1.5” (6 mm x 38 mm) PN# 800-0271-DEN
- Europe: 0.390” x 0.975” (10 mm x 25 mm) PN# 800-0271-EU
- Eschmann (UK): 0.237”x 1.245” (6 mm x 32 mm) PN# 800-0271-UK
- Japan: 0.354” x 1.260” (9 mm x 32 mm) PN# 800-0271-JPN
- Swiss: 0.394” x 1.1181” (10 mm x 30 mm) PN# 800-0271-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
- 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.
CLEANING AND STERILIZATION INSTRUCTIONS
- Clean Wrist Tower thoroughly before using (before sterilization) and after each use
- Recommended cleaning products: (All solutions should be used in accordance with manufacturer’s instructions)
- Enzymatic neutral pH detergent solution (Enzymatic cleaners are compatible with metal devices/instruments and are preferred)
- Non-enzyme, hydrogen peroxide based solution
- Coverage Plus NPD One Step Cleaner, Disinfectant & Deodorizer Concentrate
- Disassemble Wrist Tower into separate parts for cleaning:
- CamLoc Clamp
- Scrub each piece with a soft, plastic scrub brush and a recommended cleaning solution (see above)
- Rinse all parts thoroughly to remove any chemical residue
- Wipe each part completely dry with a clean, lint-free cloth
- Prepare for sterilization (device must be cleaned before sterilization)
- See sterilization instructions below
*Based on information provided by the Healthcare Infection Control Practices Advisory Committee (HICPAC), the Center for Disease Control (CDC), the National Center for Biotechnology Information (NCBI) and the U.S. National Library of Medicine.
Exposure Time at 132° C (270° F): 4 minutes
Drying Time: 40 minutes
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-800-0135 REV 3.02
Basic UDI-DI: 081001460F0068EJ
Latest Revision: 9/15/2021