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Narrow Headrest 800-0052
Narrow Headrest (EU) 800-0052-EU
Narrow Headrest Pad 508-0109
Device Initial Release: 8/21/2008
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | email@example.com
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands
INSTRUCTIONS FOR USE
Attaching Headrest to Surgical Table
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.
Detaching Headrest from Surgical Table
- Remove surgical table head section.
- Place Universal Rail Clamps P/N 800-0085 or P/N 800-0228-EU (sold separately) on both sides of surgical table side rail at end of head section.
- Slide Narrow Headrest mounting blades into clamps.
- Turn clamp handles clockwise to secure Narrow Headrest.
- Turn clamp handle counterclockwise to loosen headrest and remove.
Optional Wrist Rest P/N 800-0086 (sold separately)
Intended use is to improve surgeon’s access to head of surgical table during ENT, neuro-surgery, plastic surgery and ophthalmic surgery.
Device Dimensions (maximum)
- Length: 25” +/- 0.5” (64 cm +/- 1 cm)
- Width: 20”W (51 cm) at base and 8”W (20 cm) at head
- Depth: 10.5” +/- .5” (27 cm +/- 1 cm), 2.25” (6 cm) with pad
- Device Weight: 8 +/- 0.5 lbs. (3.6 +/- .22 kg)
- Single-person installation
- Optional Wrist Rest sold separately P/N 800-0086
- Optional Universal Rail Clamp, 2 each required P/N 800-0085 (sold separately)
- Optional Simple Clamp (EU), 2 each required P/N 800-0228-EU (sold separately)
Narrow Headrest is a surgical table accessory that improves surgeon’s access to head of surgical table. Ideal for neurological procedures.
Other required products for use:
800-0085 Universal Rail Clamp, 2 each (800-0052) (sold separately)
800-0228-EU Simple Clamp (EU), 2 each (800-0052-EU) (sold separately)
800-0086 Optional Wrist Rest (sold separately)
508-0109 Narrow Headrest Pad
- Product not made with (NRL) Natural Rubber Latex
- Device supports 500 lb. (227 kg) proportional patient load (6'4" (193 cm) 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.
- 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)
- 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
Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
Surgical table load capacities may be less. Never overload surgical table. Device is intended for mounting on surgical table side rail only.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
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.
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
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-800-0052 REV 3.03
Basic UDI-DI: 081001460F0061E4
Latest Revision: 9/15/2021