Integra MAYFIELD Spine Table Adapter A2600R User manual

MAYFIELD® Spine Table Adaptor
( A2600R and A2600M)
Instruction Manual
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]
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MAYFIELD® Spine Table Adaptor
( A2600R and A2600M)
Instruction Manual
EN – ENGLISH

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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
This device is not indicated for use in the MR environment
Catalog number
Date of manufacture (YYYY-MM-DD)
Lot number
Serial number
No tools
Medical Device

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EN – ENGLISH
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 Integra
LifeSciences Corporation, Cincinnati, Ohio or an authorized Integra repair center for evaluation,
repair or replacement.
1. Jaw
2. Lock Knob
3. Base Handle Adjustment Knob
4. Connecting Tube
5. Latch
6. Locking Lever
7. Base Handle
8. Link Arm
9. Link Arm Locking Knob
10. Swivel Adaptor
11. Skull Clamp/Headrest Locking Knob
Figure 1 Spine Table Adaptor A2600R Components

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EN – ENGLISH
1. Jaw
2. Lock Knob
3. Base Handle Adjustment Knob
4. Connecting Tube
5. Latch
6. Locking Lever
7. Base Handle
8. 6” Transitional Member
9. Torque Screw
10. Swivel Adaptor (Optional)
11. Skull Clamp/Headrest Torque Screw
Figure 2 Spine Table Adaptor A2600M Components

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Indication for Use/Intended Purpose
The MAYFIELD® Spine Table Adaptor is intended to be used to support a patient during diagnostic
examination and/or surgical procedures where a rigid support between the carbon composite parallel
rails style of surgery table and the skull clamp or headrest is necessary and positional freedom is
required. (Item number A2600R is indicated for use when X-ray imaging modalities are required)
WARNING!
Failure to read and follow instructions furnished in this product insert may result in
skull pin slippage and serious patient injury, such as scalp lacerations, skull fracture,
or even death.
Do not steam sterilize; components may be damaged by high heat leading to device
damage and reduced performance.
When using a skull clamp or headrest with this device, be certain to securely fasten it.
Before fully tightening, always be certain that the starburst teeth of the components
are the same size and mesh properly. Failure to do so may result in serious patient
injury. Failure to properly position patient and to fully tighten and secure all adjustable
portions of this or any similar device may result in skull pin slippage and serious
patient injury, such as scalp laceration, skull fracture, or even death.
The user must make sure that any threaded connections are secure and starbursts
have meshed (where applicable) aer adjustments are complete. Failure to do so
may result in serious patient injury.
Do NOT alter the construction of this device as it may result in serious patient injury.
CAUTION!
Always make sure the Spine Table Adaptor is properly secured to the operating
table. Use only MAYFIELD brand cranial stabilization components with this device.
In instances where a horseshoe headrest may be used with this product, use the
traction system supplied by the bed manufacturer and not the pulley rod.
The Spine Table Adaptor must not be used if the device appears to be damaged or
not functioning correctly.
Over-tightening the mechanisms adjustment screws may result in damage to the
Adaptor.
Over extending or overloading the Spine Table Adaptor may result in unintended
movement, shortened product life and/or damage to the Adaptor.
The MAYFIELD Base Handle must never be in the locked position without a
transitional member (or link arm) in its receptacle. Failure to do so may result in
damage to the handle receptacle.

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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.
Description
The MAYFIELD Spine Table Adaptors (A2600R, A2600M) are designed to provide aachment from
parallel rails style of surgery tables to MAYFIELD Skull Clamps for rigid skeletal fixation or MAYFIELD
Horseshoe Headrests for procedures where non-rigid fixation is required. The Spine Table Adaptor
is designed for patient positioning in the prone, lateral or supine positions for aachment to either
a skull clamp or a horseshoe headrest. It aaches to the two parallel rails of a spinal surgery table
with easy adjustment knobs.
The Spine Table Adaptor is available in a standard model (A2600M) for use with standard MAYFIELD
Skull Clamps and Headrests when intra-operative imaging is not a requirement. It is also available
in a model (A2600R) suitable for X-ray, Digital subtraction Angiography (DSA), Fluoroscopy and CT
imaging modalities.
The components of the Spine Table Adaptor are easy and familiar to assemble for use and
disassemble for cleaning and storage. It is recommended that it is stored in the assembled mode to
be ready for the next use.
Optional Tri-Star Swivel Adaptors are available for use with the Spine Table Adaptor when
image-guided surgery (IGS) systems are used in the procedures. These Tri-Star Swivel Adaptors
provide two extra starbursts for aachment of the ancillary IGS equipment. See separate
Instruction Manuals for these devices.

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Tri-Star Swivel Adaptors:
Used with the A2600M – A2008 Tri-Star Swivel Adaptor
Used with the A2600R – A2111 Tri-Star Swivel Adaptor
The Spine Table Adaptor - A2600M is designed for use with the following equipment:
A1008 MAYFIELD General Purpose Headrest
A1011 MAYFIELD Horseshoe Headrest
A1012 MAYFIELD Horseshoe Headrest
A1018 MAYFIELD Swivel Adaptor
A1051 MAYFIELD Pediatric Horseshoe Headrest
A1059 MAYFIELD Modified Skull Clamp
A1064 MAYFIELD Ball Socket Swivel Adaptor
A1108 MAYFIELD Triad Skull Clamp
A1114 MAYFIELD Infinity Skull Clamp System
A1114A MAYFIELD Infinity Skull Clamp
A1115 MAYFIELD Modified Swivel Adaptor
A1116 MAYFIELD Modified Tri-Star Swivel Adaptor
A2000 MAYFIELD 2000 Skull Clamp
A2008 MAYFIELD Tri-Star Swivel Adaptor
The Spine Table Adaptor - A2600R is designed for use with the following equipment:
A2002 MAYFIELD Radiolucent Skull Clamp
A2010 MAYFIELD Adult Radiolucent Horseshoe Headrest
A2011 MAYFIELD Pediatric Radiolucent Horseshoe Headrest
A2114 MAYFIELD Infinity XR2 Radiolucent Skull Clamp
A2111 MAYFIELD Infinity XR2 Radiolucent Tri-Star Swivel Adaptor
NOTE: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s
stabilization equipment is not recommended.

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Removal of Shipping Plug from the Base Handle
The Spine Table Adaptor is packed with a Shipping Plug in the opening of the Base Handle that
should be removed in order to assemble the appropriate Transitional Member (A2600M) or the
Spine Table Adaptor Link Arm (A2600R).
Follow these steps:
1. Open the Base Handle.
2. Remove and discard the Shipping Plug.
3. Insert the Spine Table Adaptor Link Arm into the Base handle and close.
Figure 3 A2600R Removal/Set-up
CAUTION!
The MAYFIELD Base Handle must never be in the locked position
without a transitional member (or link arm) in its receptacle.
Failure to do so may result in damage to the handle receptacle.
NOTE: It is important to periodically assess/verify the tension on the locking lever. Adjustment may
be necessary to compensate for changes which occur with normal use.