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Premium Head & Chin Straps 800-0369
Device Initial Release: 8/13/2020
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 features of patient positioning device before use with patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
- Place patient on surgical table/shoulder chair in supine position
- Once patient is intubated, hold patient’s head/neck, raise shoulder chair up so patient is in Fowler (sitting) position
- Loosen ball joint - adjust head positioner around patient’s head making sure patient’s ears are uncovered - tighten ball joint
- Hold head positioner flaps along side of patient’s head, placing Forehead Strap across forehead as shown. Attach securely and avoid covering patient’s eyebrows.
- Center Chin Strap over chin, secure strap to one side of head positioner. Making sure head is properly positioned, secure strap’s other end to opposite side of head positioner.
NOTE: Head should be securely positioned. If not, make straps a little tighter.
INTENDED USE
Intended use is to hold the patient’s head during operative procedure.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 21” +/- 0.5” (53 cm +/- 1 cm) (Head)
- Length: 22” +/-0.5” (56 cm +/- 1 cm) (Chin)
- Width: 2” +/-0.5 (5 cm +/- 1 cm) (Both Head and Chin)
- Device Weight: 0.066 lbs. +/- 0.02 lbs. (.03 kg +/- .009 kg)
- Attaches to head section of SchureMed Shoulder Chairs
- Single-person installation
COMPONENT OVERVIEW
Premium Head & Chin Straps holds a patient’s head securely during operative procedure.
GENERAL INFORMATION
- 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
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-800-0369 REV 3.07
Basic UDI-DI: 081001460F0012DP
Latest Revision: 7/28/2021