Integra MAYFIELD A1117 User manual

MAYFIELD®
MR/X-ray Skull Clamp with Excite 3.0T Adaptor
( A1117)
Instruction Manual
Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227, USA
Tel: [phone]
Fax: [phone]
integralife.com
Integra LifeSciences Services (France) SAS
Immeuble Séquoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest, FRANCE
Phone: [phone]
Fax: [phone]
EN –ENGLISH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FR –FRANÇAIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IT –ITALIANO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
DE –DEUTSCH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ES –ESPAÑOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
NL –NEDERLANDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
BR –PORTUGUÊS .............................................................
PL –POLSKI...................................................................
CZ –ČEŠTINA.................................................................
IMPORTANT
Please Read

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Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227, USA
Tel: [phone]
Fax: [phone]
integralife.com
Integra LifeSciences Services (France) SAS
Immeuble Séquoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest, FRANCE
Phone: [phone]
Fax: [phone]
EN – ENGLISH
MAYFIELD®
MR/X-ray Skull Clamp with Excite 3.0T Adaptor
( A1117)
Instruction Manual
IMPORTANT
Please Read

4
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 directive 93/42/EEC
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
Some components of this device are not indicated for use in
MR environment
Catalog number
Date of manufacture (YYYY-MM-DD)
Lot number
Serial number

5
EN – ENGLISH
Inspection
Always inspect instruments before and aer each use. If an instrument appears damaged and/
or does not seem to function properly, immediately send the instrument to Integra for repair or
replacement.
The A1117 MAYFIELD® MR/X-ray Skull Clamp with Table Adaptor includes:
FD EE
A
B
A
B
C
C
G
H
Description Part Number
C
D
E
F
G
H
Small Adult Rocker Assembly
Larger Adult Rocker Assembly
Applicator Assembly
GE Skull Clamp Assembly
Transfer Board Knob (Qty 2)
Table Adaptor
Child Rocker Assembly (Optional)
Decagon Mounting Assembly (Optional)
428A2030
428A2040
428A2020
428C1000
428A2004
428C1001
428A2050
428A2060
A
B
Figure 1 Components

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EN – ENGLISH
I M I MN N
IJ J I
O P O Q US
K
L
K
L
R
S
T
ABC
Small Adult
Rocker Assembly
428A2030
Larger Adult
Rocker Assembly
428A2040
Applicator
Assembly
4282020
I
J
K
L
M
N
O
P
Q
R
S
T
U
Description Part Number
Thumbscrew (Qty 4)
Threaded Engagement Shaft Long
GE-Piston-Long (Qty 2)
GE-Piston-Short (Qty 2)
Threaded Engagement Shaft Short
Small Locking Nut (Qty 2)
Hex Engagement Teeth (Qty 2)
Small Adult Rocker Arm
Large Adult Rocker Arm
Caliper Gauge
Decagon Lock Ring (Qty 2)
Piston Driver
Force Applicator
428A1019
428A2010L
428A1022B
428A1022A
428A2010S
428A1017
428A1015
428A1014A
428A1014
428A1066
428A1071
428A1060
428A1008
Figure 1a Rocker Assemblies and Adaptor Assemblies

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EN – ENGLISH
Childs Rocker
Assembly
428A2050
Decagon Navigation
Arm Assembly
428A2060
I
J
K
N
O
V
S
W
Description Part Number
Thumbscrew
Threaded Engagement Shaft Long
GE-Piston-Long
Small Locking Knob
Hex Engagement Teeth
Child Rocker Arm
Decagon Lock Ring (Qty 2)
Navigation Arm Assemblies (Qty 2)
428A1019
428A2010L
428A1022B
428A1017
428A1015
428A1014C
428A1071
428A1083
S
SIJ
N O V
W W
K
GH
Figure 1b Optional Accessories

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EN – ENGLISH
Indications for Use
The MAYFIELD MR/X-ray Skull clamp is placed on the patient’s skull to hold their head and neck
securely in a particular position when rigid fixation is desired. The clamp is indicated for use in
open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities, such as
intraoperative CT and MR imaging, C-Arm X-ray and digital subtraction techniques.
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.
WARNING!
When using this skull clamp in a Magnetic Resonance environment, use ONLY MRI
compatible skull pins.
WARNING!
The force applicator is NOT MR compatible and must be removed prior to scanning
in an MR environment.
WARNING!
MAYFIELD Skull Clamp fixation devices are not recommended for use on children
under five (5) years of age and extreme caution should be exercised in pediatric
cases because of the thin skull.
WARNING!
Do not hold or use rocker arm as leverage when unlocking unit. This may cause
damage to the rocker arm.

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EN – ENGLISH
Table 1 Skull Clamp Position Diagram
Figure A
Figure B
Figure C
FFF
SKULL CLAMP
HEAD
HEAD
Co
rrect
In
correct
Co
rrect
L
C
L
C
SKULL CLAMP
L
C
F = APPLIED
FORCE
Table 1 Skull Clamp Position Diagram
NOTE: Patient positioning and application of the skull clamp can be made with numerous
variations. The patient’s final position should be acceptable to the surgeon, taking into account the
patient’s anatomy, pressure points, neck flexibility and access to the surgical target.
In the chart above, the ovals representing the patient’s head have centerlines drawn on them. The
diagrams show examples of proper and improper applications of the skull clamp. The direction
of the single-pin should point directly through the center point created by the centerlines of the
patient’s head with the pins on the two-pin side of the skull clamp being equidistant to the single-
pin line of direction to obtain the highest degree of stability.

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Description
The MAYFIELD® MR/X-ray Skull Clamp with Table Adaptor (Catalog # A1117) is designed to provide
rigid skeletal fixation for procedures involving imaging modalities such as intra-operative MR,
CT, and digital subtraction angiography. This device is MR compatible* when used in the MR
environment at field strengths up to 3 tesla (T).
*MR Compatible is defined by the CDRH Magnetic Resonance Working Group (Feb. 7, 1997) dra
document A Primer on Medical Device Interactions with MRI Systems as “the device, when tested
in the MR environment, is MR Safe and has been demonstrated to neither significantly affect the
quality of the diagnostic information nor have its operations affected by the MR device.”
This system is comprised of the MAYFIELD MR/X-ray Skull Clamp (428C1000) and Table Adaptor
(428A1001). The MAYFIELD MR/X-ray Skull Clamp with Table Adaptor is designed for patient
positioning in the prone or supine positions. The Table Adaptor aaches to the Excite 3.0T diagnostic
table.
The MAYFIELD MR/X-ray Skull Clamp is designed to allow the surgeon more freedom in positioning
the fixation pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arm
which rotates 360°, making application much easier. In addition, the swiveling rocker arm can
rotate 360° under full skeletal force making final positioning aer pin impingement much easier. Its
lean body design also allows for greater exposure to the operative site.
The MAYFIELD MR/X-ray Skull Clamp requires the use of three (3) each MAYFIELD Skull Pins.
(Available styles: A2020 MAYFIELD Radiolucent Skull Pins, A1120 MAYFIELD Titanium Disposable
Adult Skull Pins, A1119 MAYFIELD Titanium Disposable Child’s Skull Pin).
NOTE: The components of the MR/X-ray Skull Clamp are manufactured from plastic materials
which leave only a small artifact during intraoperative angiographic or radiographic procedures
using digital subtraction (D.S.A.).
CAUTION!
If any component is damaged or cracked, the complete system should be returned to
Integra for inspection and repair to assure the integrity of the composite components.

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EN – ENGLISH
Mounting of Table Adaptor
1. Lay the adaptor on the table edge and position the thru holes of the Bracket Assembly over the
threaded inserts of the table.
2. Use the provided threaded fasteners to lock the table adaptor in place.
3
1
2
D
Figure 2 Mounting Table Adaptor
CAUTION!
CAUTION: Make sure the table adaptor is properly secured to the operating table.
NOTE: If desired the table adaptor may be used without the extension arms, permiing the skull
clamp to be positioned lower on the table. (See Figure 3).

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EN – ENGLISH
To use the clamp in the position shown in Figure 3 the adaptor must be disassembled from the
standard configuration first.
Figure 3 Clamp without Extension Arms Figure 4 with Extension Arms
Choice of Rocker Arm for Patient
1. Choose the appropriate rocker arm as is indicated for the patient. (An Optional Child’s Rocker
Arm is available). To determine the rocker arm to be used, measure the patient’s head as shown in
Figure 5 below with the GE Caliper (428A1066) provided. Next, lay the Caliper indicating the width
of the patient’s head onto the Gauge Template provided with this instruction manual. The Gauge
Template will show whether to use the Small Adult or the Large Adult rocker arm . (See Figure 6).
Caliper Gauge Template
imagination at work
Child Rocker
Assembly
(optional)
Small Adult
Rocker
Assembly
Large Adult
Rocker
Assembly
R
P
Figure 5 Measuring Patient Head Figure 6 Laying Gauge On Template

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EN – ENGLISH
Assembly of Skull Clamp
1. Use of the Gauge Template has indicated whether to use a short or long Piston and which of the
rocker arms (Small or Large) to use with the patient. Insert the indicated Piston into the clamp
upright as shown in Figure 7. The end of the Piston should be positioned as shown.
1
J
I
M
or
K L
or
Figure 7 Piston Installation
2. Assemble the rocker arm to the clamp upright as shown in Figure 8.
1
2
3
x2
O
N
P Q V
or or
Figure 8 Rocker Arm Assembled to Clamp
3. Aach rocker arm to skull clamp with small locking knob turning 2 rotations.
DO NOT overtighten.

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EN – ENGLISH
4. Push the MRI safe skull pins as far as possible into the pin receptacles of the rocker arm and the
single-pin side of the clamp. (See Figure 9 and 10 below). Use only MAYFIELD brand Disposable
Skull Pins with this clamp.
NOTE: It is recommended that a spare set of skull pins always be kept available.
1
1
Figure 9 Rocker Arm Skull Pins Installation
1
Figure 10 Skull Pin Installation Single Side of Clamp

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EN – ENGLISH
NOTE: Install skull pins. Seat pins so there is no gap between the shoulder of the pin and the face
of the socket
Seat pins so there is no gap
between the shoulder of the pin
and the face of the socket
Adult Rocker
Childs Rocker Arm
Figure 10a Proper Skull Pin Installation

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EN – ENGLISH
Skull Clamp Patient Fixation
WARNING!
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.
WARNING!
WARNING: MAYFIELD Skull Clamp fixation devices are not recommended for use
on children under five (5) years of age and extreme caution should be exercised in
pediatric cases because of the thin skull.
CAUTION!
CAUTION: 60 lbs. (267 N)of force is recommended for adults. 40 lbs. (178 N) of force
is recommended for children. All force seings are at the user’s discretion. NEVER
exceed 80 lbs. (356 N) of force. Do not over tighten.
1. Unlock the locking knob so the rocker arm can rotate freely 360°. The locking knob is unlocked
by rotating it counter-clockwise one (1) complete turn or 360°.
2. Rotate the rocker arm into the desired position. This position is normally perpendicular to the
floor for prone or supine positions. This will also align the rocker arm parallel with the direction
of the surgical force (Table 2 on back).
3. Position the two (2) skull pins in the rocker arm so they are equidistant from the centerline of
the head (Figure 11).
Correct Incorrect
Figure 11
CAUTION!
Avoid the areas of the frontal sinus, temporal fossa, major blood vessels, nerves,
previously restored or abnormally thin bone.

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EN – ENGLISH
CAUTION!
Make sure the trajectory of the single pin in the skull clamp intersects the center of
the patient’s head and the rocker arm to correctly secure the patient’s head into the
skull clamp.
4. Proper fixation to the skull requires selection of the appropriate length piston and
engagement sha. (See Figure 12 below.) The engagement sha should be inserted
near flush with the exterior face of the threaded housing. The appropriate piston
length should be threaded into the engagement sha until the skull pin makes
contact with the skull. A Piston Driver is provided for use when the piston is difficult
to access.
Threaded Housin
g
Engagemen
t
Sha
ft
Piston
Figure 12
5. The skull pins should be firmly seated in the cranial table by threading the force appli-
cator on the clamps’ threaded housing.
1
2
T
Figure 13

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EN – ENGLISH
6. Increase skull clamp force by advancing the Force Applicator to the desired seing as
denoted on the visual readout, and then back off one quarter turn.
Figure 14
NOTE: The visual readout on the Force Applicator gives the surgeon the clamping force being
applied.
Force Applicator
Vi
sual Readout
T
humbscrew
Torque Screw
Line Indicator
Clamping
Force
1
2
3
4
=
=
=
=
20 lbs. (89 N)
40 lbs. (178 N)
60 lbs. (267 N)
80 lbs. (356 N)
Figure 15
NOTE: To achieve independent fixation for adults, it is recommended that a minimum of 60 lbs. (267
N) of force be applied by the Skull Clamp. An additional force of 80 lbs. (356 N) is available if desired.
WARNING!
WARNING: Loading in excess of 80 lbs (356 N) is NOT RECOMMENDED.

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EN – ENGLISH
7. Before removing the Force Applicator the thumbscrew should be advanced until it
comes into contact with the inner clamp face. Once contact is achieved, do not
tighten the thumbscrew. The applicator can now be removed.
11
Figure 16
NOTE: Stop rotation when thumbscrew is touching skull clamp. Over rotating will
increase force on pin.
40
20
1
2
12
U
Figure 17
IMPORTANT: Force Applicator must be removed prior to scanning in an MR
environment. Remove Force Applicator only aer thumbscrew is set.

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EN – ENGLISH
Positioning of Skull Clamp
1. Position the skull clamp frame on patient as shown.
Figure 18
2. Once the patient is pinned, rotate the skull clamp beneath the patient’s head.
Figure 19
3. Lock the rocker arm in place by rotating the locking knob clockwise until it becomes tight. The
rocker arm is now fully locked and the skull clamp is securely fastened to the patient.