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Narrow Headrest 800-0052
Narrow Headrest (EU) 800-0052-EU
Replacement Pad
Narrow Headrest Pad 508-0109
INTENDED USE
Intended use is to improve surgeon’s access to head of surgical table during ENT, neuro-surgery, plastic surgery and ophthalmic surgery. The intended users of this device are medical professionals within hospitals and surgery centers.
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.
Attaching Headrest to 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.
Detaching Headrest from Surgical Table
- Turn clamp handle counterclockwise to loosen headrest and remove.
Optional Wrist Rest P/N 800-0086 (sold separately)
GENERAL SPECIFICATIONS:
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)
COMPONENT OVERVIEW
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)
Replacement Pad
508-0109 Narrow Headrest Pad
GENERAL INFORMATION
- 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)
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!
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.
WARNING!
Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
WARNING!
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
WARNING!
Surgical table load capacities may be less. Never overload surgical table. Device is intended for mounting on surgical table side rail only.
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-800-0052 REV 3.04
Basic UDI-DI: 081001460F0061E4
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
Symbol Glossary
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