Integra MAYFIELD 2 User manual

MAYFIELD

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: +33 (0)4 37 47 59 50 • +33 (0)4 37 47 59 25 fax

Benelux: +32 (0)2 257 4130 • +32 (0)2 253 2466 fax

France: +33 (0)4 37 47 59 10 • +33 (0)4 37 47 59 29 fax

Germany: +49 (0) 2102 5535 6200 • +49 (0)2 102 5536 636 fax

Switzerland: +41 (0)22 721 23 00 • +41 (0)22 721 23 99 fax

United Kingdom: +44 (0)1 264 345 780 • +44 (0)1 264 363 782 fax

integralife.eu

Manufacturer:

Integra LifeSciences Corporation

4900 Charlemar Drive, Building A, Cincinnati, OH 45227, USA.

Tel: 1-513-533-7979 Fax: 1-513-271-1915

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: +33 (0) 4 37 47 59 00

Fax: +33 (0) 4 37 47 59 99

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

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

orrect

Inc

orrect

SKULL CLAMP

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

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.

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