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Disposable Face Masks 800-0164
Device Initial Release: 4/16/2010
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 patient positioning device’s features before use with patient. Always practice on a nurse, physician or appropriate volunteer prior to using clinically.
- Place patient on surgical table/shoulder chair in supine position
- After intubating patient, while holding patient’s head and neck - raise shoulder chair up, so patient is in Fowler (sitting) position
- Loosen ball joint and adjust head positioner around patient’s head. Make sure patient’s ears are uncovered. Then tighten ball joint.
- Holding head positioner flaps along side patient’s head, place face mask over face as shown - making sure eyes, nose and mouth are uncovered
- Affix top and bottom velcro straps of mask on one side to head positioner. Then affix other side as shown - making sure facemask is centered over face.
NOTE: Head should be securely positioned. If not, make straps a little tighter.
Intended use is to hold patient’s head during operative procedure.
Device Dimensions (maximum)
- Length: Strap: 29” +/- 0.5” (74 cm +/- 1 cm), Face Mask: 9” +/-0.5” (23 cm +/- 1 cm)
- Width: 13.5” +/-0.5” (34 cm +/- 1 cm)
- Depth: 1” +/-0.5” (2.5 cm +/- 1 cm)
- Device Weight: 0.25 +/- 0.5 lbs. (.11 +/- .22 kg)
- Attaches to head section of SchureMed Shoulder Chairs
- Single-person installation
Disposable Face Mask securely holds a patient’s head during operative procedure. Straps are soft and pliable to attach to head frame.
- Product not made with (NRL) Natural Rubber Latex
- 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
- Store device between –4°F to +86°F (-20°C to 30°C)
SINGLE PATIENT USE—Please dispose after each use
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-800-0164 REV 3.08
Basic UDI-DI: 081001460F0011DM
Latest Revision: 7/28/2021