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Uro-Trapper System 800-0096
Disposable Accessories
Uro-Trapper Drain Bags, 10/cs 800-0095
Uro-Trapper Drain Bags, Sterile, 10/cs 800-0098
Device Initial Release: 2/15/11
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
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.
Step 1: Connect mounting clamp onto side rail as shown repeat Step 1 for opposite side
Step 2: Lock down both sides using locking knobs
Step 3: Insert 800-0095 or 800-0098 hose inside hoop before sliding Drain Bag on
Step 4: Install Drain Bag onto hoop frame as shown below
Step 5: Slide Drain Bag down hoop until cuff reaches table pad as shown.
Step 6: Tuck top of Drain Bag under patients buttocks. Ensure drainage screen is at bottom most part of drain to allow full drainage of fluids.
INTENDED USE
Intended use is to hold a drain bag which collects patient’s fluid during a surgical procedure.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 49” +/- 0.5” (125 cm +/- 1 cm)
- Width: 5” +/- 0.5 (13 cm +/- 1 cm)
- Device Weight: 2 +/- 0.5 lbs. (.9 +/- .22 kg)
- Attaches to end of surgical table side rail
- Single-person installation
COMPONENT OVERVIEW
Uro-Trapper System is used to hold a drain bag that stores fluid from surgical procedures.
Other required products for use:
800-0095 Uro-Trapper Drain Bags or 800-0098 Uro-Trapper Drain Bags, Sterile
GENERAL INFORMATION
- Product not made with (NRL) Natural Rubber Latex
- 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!
Item does not hold a patient therefore item does not have any patient weight restrictions.
WARNING!
Hazard resulting from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses Journal Guidelines for proper cleaning and disinfection procedures.
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.
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-800-0096 REV 3.05
Basic UDI-DI: 081001460F0049EE
Latest Revision: 9/15/2021