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DISPOSABLE FACE MASKS 800-0164
Initial Release: 4/16/2010
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 Manufacturer
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.
- Place the patient on the surgical table/shoulder chair in the supine position
- After the patient is intubated, while holding the patient’s head and neck raise the shoulder chair up so that the patient is in the Fowler (sitting) position
- Loosen the ball joint and adjust the head positioner around the patient’s head making sure the patient’s ears are free and not covered and tighten the ball joint
- While holding the head positioner flaps along the side of the patient’s head, place the face mask over the face as shown making sure the eyes, nose and mouth are not covered
- Affix top and bottom Velcro Straps on one side of the mask to the head positioner and then do the same to the other side as shown making sure the facemask is centered over the face
NOTE: The head should be securely positioned. If not, make the straps a little tighter.
Intended Use
The intended use is to hold the patient’s head during the operative procedure.
General Specifications
Device Dimensions (maximum)
- Length: 29” +/- 0.5” (Strap), 9” +/-0.5” (Facemask)
- Width: 13.5” +/-0.5”
- Depth: 1” +/-0.5”
- Device Weight: 0.25 +/- 0.5 lbs
- Attaches to the head section of Schuremed Shoulder Chairs
- Single person installation
- SINGLE PATIENT USE—Please dispose of after each use
Overview of Components
The DISPOSABLE FACE MASK is used to hold a patient’s head securely during the operative procedure. Straps are soft and pliable to attach to the head frame.
General Information
- Product not made with (NRL) Natural Rubber Latex
- Device supports 500 lb proportional patient load (6'4" 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.
- 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
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!
Product should not exceed maximum load 500 lb. patient. Restrictions result from the permissible overall load, among other things, of accessory rails when using operating tables with a low maximum load capacity. Strictly follow instructions for your Operating Table system.
WARNING!
Hazard resulting from incorrect use. Strictly follow instructions for your Operating Table system.
Cleaning Recommendation
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.
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
