Integra MAYFIELD Pediatric Radiolucent Horseshoe... User manual

MAYFIELD® Pediatric Radiolucent
Horseshoe Headrest
( - A2011)
Instruction Manual
REF
EN – English ...............................................................................................................................2
FR – Français ..............................................................................................................................15
IT – Italiano ................................................................................................................................29
DE – Deutsch .............................................................................................................................43
ES – Español ..............................................................................................................................56
NL – Nederlands........................................................................................................................69
Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227, USA
Tel: [phone]
Fax: [phone]
integralife.com
Integra LifeSciences Services
Immeuble Séquoïa 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest – France
Tel: [phone]
EC REP

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EN – ENGLISH
2
MAYFIELD® Pediatric Radiolucent
Horseshoe Headrest
(REF - A2011)
Instruction Manual

3
EN – ENGLISH
Meaning Of Symbols Used In This Manual - ENGLISH
CAUTION!
Hazards which could result in equipment or property damage
WARNING!
Hazards which could result in severe personal injury or death
Caution
Product complies with the requirements of MDR 2017/745
Manufacturer
Authorized Representative in the European Community
Consult Instructions for Use
Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
Catalog number
Date of manufacture (YYYY-MM-DD)
Lot number
Serial number
Medical Device
REF
LOT
SN

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EN –ENGLISH
Indications for Use/Intended Purpose
The MAYFIELD® Pediatric Radiolucent Horseshoe Headrest is intended to be used to support a patient’s head in both the prone and supine
positions during diagnostic examination or surgical procedures where support and stabilization of the head is desired but complete
fixation of the head is not required.
WARNING:
Failure to read and follow instructions furnished in this product insert may result in serious patient injury.
WARNING:
Device must not be used if it appears to be damaged or functioning incorrectly. Doing so may result in serious patient injury.
WARNING:
Ensure the mating starburst teeth of the Swivel Adaptor and the Stationary Horseshoe Faceplate are the same size and have
properly engaged (meshed) when fully tightened. Failure to do so may damage teeth, compromise stability, and result in serious
patient injury.
WARNING:
Do not position the Slide Horseshoe Faceplate past the end of the Stationary Horseshoe Faceplate slide bar (Figure 11). Doing so
may result in serious patient injury.
WARNING:
Horseshoe Faceplates should be adjusted prior to patient positioning. Make certain to always support the patient’s head when
adjusting the Horseshoe Faceplates or unlocking any connection of this device. Failure to do so may result in serious patient injury.
WARNING:
Failure to properly position the patient and to fully secure all adjustment portions of this or any support device may result
in serious patient injury.
WARNING:
Device must not be used if it has been dropped or mishandled. Doing so may result in serious patient injury.
WARNING:
Do not steam sterilize any component of this device. Doing so may damage device and result in serious patient injury.
WARNING:
Do not use MAYFIELD products and accessories in conjunction with other manufacturers’ stabilization equipment.
Intended Population
MAYFIELD Skull Clamp fixation devices are not recommended for use on children under five (5) years of age. Extreme caution should be
exercised in pediatric cases because of the thin skull.

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Description
The MAYFIELD Pediatric Radiolucent Horseshoe Headrest (Figure 1) is designed to provide support and stabilization of the head in
conjunction with the MAYFIELD Radiolucent Base Unit (REF A-1079, Figure 2) of the MAYFIELD Radiolucent Headrest System (REF A-2004).
Figure 1
Figure 2

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The MAYFIELD Pediatric Radiolucent Horseshoe Headrest includes (Figure 3):
1. Stationary Horseshoe Faceplate, Pediatric
2. Slide Horseshoe Faceplate, Pediatric
3. Adjustment Knob
4. Horseshoe Gel Pad, Pediatric Le
5. Horseshoe Gel Pad, Pediatric Right
Figure 3
The MAYFIELD Pediatric Radiolucent Horseshoe Headrest is designed to aach to the Short Swivel Adaptor (Figure 4) of the MAYFIELD
Radiolucent Base Unit. If extra starburst aachments for ancillary equipment are desired, the MAYFIELD Pediatric Radiolucent Horseshoe
Headrest may be aached to the MAYFIELD Radiolucent Tri-Star Swivel Adaptor (REF A-1111, Figure 5) of the MAYFIELD Radiolucent
Headrest System (REF A-2004) in conjunction with the MAYFIELD Radiolucent Base Unit.
Figure 4 Figure 5
The MAYFIELD Pediatric Radiolucent Horseshoe Headrest is designed to be used with the included Horseshoe Gel Pads. Replacement Gel
Pads are available individually (REF 4-40-C-1011 Pediatric Le and 4-40-C-1012 Pediatric Right).
WARNING:
Do not use MAYFIELD products and accessories in conjunction with other manufacturers’ stabilization equipment.

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Inspection
Always inspect instruments before and aer use. If a component appears damaged and/or does not seem to function properly, do not use
the device and immediately send the instrument to an authorized Integra repair center for evaluation, repair or replacement. Allow your
Integra Representative to inspect this device a minimum of two times per year to assist you in its proper function.
WARNING:
Device must not be used if it appears to be damaged or functioning incorrectly. Doing so may result in serious patient injury.
Gel Pads
1. Pads should not have any rips or tears in the top surface.
2. Backs of the pads should not be broken or cracked.
Stationary Horseshoe Faceplate
1. Starburst teeth of the Stationary Horseshoe Faceplate should match up and tighten securely with the starburst teeth of the
Radiolucent Short Swivel Adaptor or Radiolucent Tri-Star Swivel Adaptor.
2. Parts should be smooth and free of cracks and voids.
3. Gel Pad should slide easily onto the Stationary Horseshoe Faceplate and snap in place.
Slide Horseshoe Faceplate with aached Adjustment Knob
1. Slide Horseshoe Faceplate should slide easily onto the Stationary Horseshoe Faceplate.
2. Adjustment Knob should turn easily and securely lock down on the slide bar of the Stationary Horseshoe Faceplate.
3. Parts should be smooth and free of cracks and voids.
4. Gel Pad should slide easily onto the Slide Horseshoe Faceplate and snap into place.
Instructions for Use
Mounting of Base Unit and Aachment of Transitional Members and Swivel Adaptor
IMPORTANT:
Refer to the MAYFIELD Radiolucent Headrest System instruction manual (REF 4-51-A-2004) for the correct usage of the MAYFIELD
Radiolucent Base Unit prior to using this device. If applicable, refer to the MAYFIELD Radiolucent Tri-Star Swivel Adaptor
instruction manual (REF 4-51-A-1111) prior to using this device.
1. Mount the MAYFIELD Radiolucent Base Unit to the operating table.
2. Aach the Transitional Members and the Short Swivel Adaptor to the Radiolucent Base Unit. If extra starburst aachments for
ancillary equipment are desired, the MAYFIELD Radiolucent Tri-Star Swivel Adaptor may be used instead of the Short Swivel Adaptor.
Aachment of Pediatric Radiolucent Horseshoe Headrest to Swivel Adaptor
1. Aach the Pediatric Radiolucent Horseshoe Headrest to the chosen Swivel Adaptor by inserting the torque screw of the Short Swivel
Adaptor (Figure 6) or the torque screw of the Radiolucent Tri-Star Swivel Adaptor (Figure 7) into the threaded hole of the Stationary
Horseshoe Faceplate such that the starburst teeth of the Swivel Adaptor are facing the starburst teeth of the Stationary Horseshoe
Faceplate.
Figure 6 Figure 7

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EN – ENGLISH
2. Turn the Swivel Adaptor torque screw clockwise several times.
3. Position the Pediatric Radiolucent Horseshoe Headrest in desired orientation and turn the Swivel Adaptor torque screw clockwise
until fully tightened (Figures 8 and 9)
Figure 8 Figure 9
WARNING:
Ensure the mating starburst teeth of the Swivel Adaptor and the Stationary Horseshoe Faceplate are the same size and have
properly engaged (meshed) when fully tightened. Failure to do so may damage teeth, compromise stability, and result in serious
patient injury.
4. Aach the Gel Pads onto the Horseshoe Faceplates as follows (Figure 10 depicts aachment of Gel Pad to Stationary Faceplate):
• Slide the Gel Pad onto the Faceplate arm between tabs A and B until the end of the Gel Pad stops at the end of the Faceplate arm.
• Pull tab C over the top edge of the Faceplate arm to lock into place.
TAB C TAB A
TAB B
Figure 10
Adjustment of Horseshoe Faceplates
1. Turn the Adjustment Knob counterclockwise until the Slide Horseshoe Faceplate can slide freely (Figure 11).
Figure 11

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2. Position the Slide Horseshoe Faceplate with respect to the Stationary Horseshoe Faceplate to accommodate the size of the patient’s
head.
3. Turn the Adjustment Knob clockwise until fully tightenend (Figure 12).
Figure 12
WARNING:
Do not position the Slide Horseshoe Faceplate past the end of the Stationary Horseshoe Faceplate slide bar (Figure 13). Doing so
may result in serious patient injury.
MAXIMUM POSTION
WHEN FACES FLUSH
Figure 13
WARNING:
Horseshoe Faceplates should be adjusted prior to patient positioning. Make certain to always support the patient’s head when
adjusting the Horseshoe Faceplates or unlocking any connection of this device. Failure to do so may result in serious patient
injury.
WARNING:
Failure to properly position the patient and secure all connections on this device may result in serious patient injury.
Cleaning
Group 1 - Non-Critical1, Heat Sensitive, pH Sensitive
• Headrests
Group 2 - Non-Critical1, Heat Sensitive, pH Sensitive, Alcohol Sensitive
• Gel Pads
WARNING:
There is no validated automated cleaning/washing/disinfection method for Group 2 (gel pads). A thorough, manual cleaning
process is recommended for these devices. Automated cleaning methods may not be effective and may result in damage and
reduced performance.
Prior to cleaning, disassemble components.
1. Remove the Gel Pads from the Horseshoe Faceplates. For each Gel Pad, pull tab C over the top edge of the Faceplate arm (refer to
Figure 10) and then slide the Gel Pad toward the end of the Faceplate arm until tabs A and B have cleared the end of the arm.
1 AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in Health Care facilities.