Integra MAYFIELD 2 User manual

MAYFIELD
®
2
Skull Clamp
(A3059)
Instruction Manual
United States, Canada, Asia, Pacific, Latin America
USA 800-997-4868 • 888-980-7742 fax
Outside USA 609-936-5400 • 609-750-4259 fax
integralife.com
Europe, Middle-East, Africa
International: [phone] • [phone] fax
Benelux: [phone] • [phone] fax
France: [phone] • [phone] fax
Germany: [phone] • [phone] fax
Switzerland: [phone] • [phone] fax
United Kingdom: [phone] • [phone] fax
integralife.eu
Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A, Cincinnati, OH 45227, USA.
Tel: [phone] Fax: [phone]
www.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]
REF

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.
Aention, consult accompanying documents.
Conforms to the European Medical Device Directive (MDD).
Manufacturing site.
European Representative.
Caution: Federal (USA) Law restricts this Device to sale by or on the
order of a Licensed practitioner.
Product catalog number
This device is not indicated for use in MR environment.
REF
MR

Page 1
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.
1. 80 lb Torque Screw (454A1090)
2. Ratchet Extension
3. Rocker Arm
4. Release Buon (both sides)
5. Index Locking Knob
6. Serial Number Label
7. Skull Clamp Base
Figure 1 A3059 Skull Clamp

Page 2
The MAYFIELD®2 Skull Clamp is designed for use with the following equipment:
A3100 MAYFIELD 2 Base Unit
A3101 MAYFIELD 2 Base Unit
A3102 MAYFIELD 2 Base Unit
A3111 MAYFIELD 2 Tri-Star Swivel Adaptor
A2600M Spine Table Adaptor, Metal
ALL Styles of MAYFIELD Skull Pins (A1047, A1048, A1072, A1083, A1084)
NOTE: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s
stabilization equipment is not recommended.
Figure A
Figure C
Figure B
FFF
SKULL CLAMP
HEAD
HEAD
C
orrect
Inc
orrect
C
orrect
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.

Page 3
Indication For Use
The MAYFIELD 2 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 Skull Clamp is indicated for use in open and
percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
The MAYFIELD 2 Skull Clamp is NOT Radiolucent.
WARNING!
Failure to read and follow the instructions furnished in this product insert may
result in serious patient injury.
The Skull Clamp must be applied along the center line of the patient’s head with
pins entering the skull perpendicularly (See Table 1). Failure to properly position
the Skull Clamp on the patient’s head could result in patient injury such as scalp
laceration due to skull pin slippage. Failure to properly position patient and to fully
secure all adjustment positions of the Skull Clamp or any support device may result
in patient injury.
It is cautioned that only MAYFIELD products have been validated for use with other
MAYFIELD products. Integra cannot advise whether other suppliers’ products
would function properly with the MAYFIELD line of products. Integra does not offer
warranty protection when a non-MAYFIELD brand product is used with a MAYFIELD
branded product.
Do not alter the design of the device in part or whole as serious patient injury could
result.
Do not use Skull Clamps to exert excessive traction during a procedure. Patient
injury could result.
Skull Clamps are not intended for use in or near the vicinity of a strong magnetic
field (MRI).
WARNING!
This device is NOT Radiolucent.

Page 4
Description
The MAYFIELD 2 Skull Clamp is designed to provide rigid skeletal fixation or stabilization in
conjunction with the Base Unit (A3100, A3101, A3102) or any other standard aluminum MAYFIELD Base
Units (A2009, A2101, A2102, A2001, A1001, A1000, A2600M) The Skull Clamp is designed to allow the
surgeon freedom in positioning the fixation pins. Avoidance of critical areas of the skull is facilitated
by a swiveling rocker arm that also rotates 360 degrees. To simplify patient re-positioning aer skull
pin impingements, the rocker may be rotated without adjustment of the impingement force imposed
by the Torque Screw (Single-pin side of skull clamp).
The MAYFIELD 2 Skull Clamp (40A3059) includes:
Standard Adult Rocker Arm
Standard Torque Screw (454A1090)
Standard Ratchet Extension
Standard Torque Screw
The torque screw can develop up to 80 lbs. (356 N) of force; graduated in 20 lb. (89 N) increments. The
knob has eight facets. One facet is labeled with the “Aention” symbol.
Figure 2 Standard Torque Screw (454A1090)

Page 5
Mounting of MAYFIELD Skull Pins
NOTE: Use only MAYFIELD brand Skull Pins with this Skull Clamp.
Seat pins so there is no gap
between the shoulder of the
pin and the face of the sock
et
Figure 3 Mounting Skull Pins
CAUTION!
Carefully inspect reusable skull pins before each use. To maintain proper fixation,
pins should be of equal length. Damaged (dull, bent, etc.) pins should be replaced.
It is recommended that spare pins always be kept available.
WARNING!
Never aempt to resharpen skull pins. Dull or bent pins should be replaced.
NOTE: When using MAYFIELD Skull Pins, follow Instructions For Use supplied with
the product.
WARNING!
Skull pins 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.
MAYFIELD Child Skull Pins are recommended for young children over the age of five
(5) years. It is at the discretion of the user, when the adult or child skull pins should
be used.
CAUTION!
Only MAYFIELD branded skull pins may be used with MAYFIELD Skull Clamps.
Integra does not offer warranty protection when a Non-MAYFIELD brand skull pin is
used with a MAYFIELD Skull Clamp.

Page 6
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.
Skull Clamp Patient Fixation
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.
1. Unlock the Index Locking Knob so the rocker arm can rotate freely 360 degrees. The Index
Locking Knob is unlocked by rotating the knob to align the indicator with the open lock
symbol;
see Figure 4.
Closed lock symbol
indicates locked position
Figure 4 Unlocking Index Locking Knob
2. Rotate the rocker arm into the desired position for placement of the skull pins; normally
perpendicular to the floor for prone or supine positions or parallel to the floor for patients in
the siing position.
NOTE: The Torque Screw force gauge provides the surgeon with a visual display of the
clamping force value. (Each line on the gauge is 20 lbs or 89 N).
This will also align the rocker arm parallel with the direction of the surgical force
(See Table 1 Skull Clamp Position Diagram).

Page 7
3. Depress both of the Release Buons on the body-portion of the Skull Clamp (See Figure 5
below) to disengage the Ratchet Extension and slide the two halves of the clamp apart to allow
placement around the patient’s head.
Figure 5 Disengaging Ratchet Extension

Page 8
4. Position the 2-pin rocker arm so the skull pins are equidistant from a center line of the head.
(see Figure 6).
5. Seat the skull pins securely into the cranial table. Skull pins should enter the scalp at a
90-degree angle, perpendicular to the surface of the head.
Correct Incorrect
NOTE: Line of pins are the same
as the center of Patient’s Head
NOTE: Line of pins do NOT
fall on the line of the center
of Patient’s Head
Figure 6 Positioning Rocker Arm Skull Pins
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 Skull Clamp to the
patient’s head.
CAUTION!
Avoid the areas of the frontal sinus, temporal fossa, major blood vessels, nerves,
previously restored or abnormally thin bone.