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Nissen Straps 800-0055
Device Initial Release: 6/30/2009
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 features of patient positioning device before use with patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
Attachment/Set Up Instructions
- Attach Simple Clamps (sold separately) onto table side rails. Insert mounting posts into clamps and securely lock into place.
- Wrap Nissen Straps around patient’s legs so pads face toward inner thighs
- Attach clips on buckle sides to mounting post clips. Adjust by lifting buckles and pulling straps.
- Loosen straps by lifting buckles then remove clips
- Loosen clamps and remove Nissen Straps by lifting them out of clamps
- Remove clamps from side rails
Device Dimensions (maximum)
Intended use is to provide a safe system for positioning patients in reverse Trendelenburg.
- Length: 48”+/- 0.5” (122 cm +/- 1 cm)
- Width: 6”+/- 0.5” (15 cm +/- 1 cm)
- Depth: 2”+/- 0.5” (5 cm +/- 1 cm)
- Device Weight: 3.5 +/- 0.5 lbs. (1.5 +/- .22 kg)
Nissen Straps are a surgical table accessory that attaches to the sides of a surgical table with an accessory clamp.
Other required products for use:
(2) 800-0228 Simple Clamp (sold separately)
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 600 lbs. (272 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)
- Clean with hospital grade disinfectant
- Pads conform to Cal #117
- 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 600 lbs. (272 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
Hazard resulting from incorrect use. Strictly follow Instructions for Use with your surgical table system.
Do not use equipment if worn, damaged, or if pieces are missing.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
Adhere to standards for blood-borne pathogens from the Occupational Safety and Health Administration (OSHA). Use recommended protective clothing, gloves, masks and eye protection to clean accessory.
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
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-800-0055 REV 3.04
Basic UDI-DI: 081001460F0062E6
Latest Revision: 9/15/2021