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Anesthesia Screen 800-0016
Device Initial Release: 3/15/2015
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 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.
Attaching to Side Rail
- Attach Schure Socket XL (sold separately) on rail. Insert mounting post into socket and lock into position by turning handle clockwise.
- Adjust screen to desired height. It is adjusts from 15” to 33” (38 cm x 84 cm). Lock in desired position by turning height adjustable lock handle clockwise.
Detaching from Side Rail
- Unlock clamp by turning handle counterclockwise and remove mounting post from socket
INTENDED USE
Intended use is to aid anesthesiologist in viewing patient during surgery.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 23” +/- 0.5” (58 cm +/- 1 cm)
- Height: 35 3/8” +/- 0.5” (90 cm +/- 1 cm)
- Depth: 1 3/4”+/- 0.5” (4 cm +/- 1 cm)
- Device Weight: 3 +/- 0.5 lbs. (1.3 +/- .22 kg)
- Attaches to rail of surgical table at any point on rail
- Single-person installation
COMPONENT OVERVIEW
Anesthesia Screen is a surgical table accessory that aids anesthesiologist in viewing patient during surgery.
Required product for use: 800-0134 Schure Socket XL (sold separately)
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0134
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0134-DEN
Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0134-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0134-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0134-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0134-SWISS
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
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
WARNING!
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.
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-800-0016 REV 3.04
Basic UDI-DI: 081005737F0043KX
Latest Revision: 9/15/2021