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.

Page 9
6. Increase Skull Clamp force by advancing the Torque Screw to a desired seing, indicated on the
visual readout, then back off one quarter turn.
NOTE: The Torque Screw provides the surgeon with a visual display of the clamping
force applied. Each scribed line indicates a 20 lbs. (89 N) increment of force. Refer
to Table 2 below:
Clamping
Force
1
2
3
4
20 lbs. (89 N)
40 lbs. (178 N)
60 lbs. (267 N)
80 lbs. (356 N)
=
=
=
=
Torque Screw
Line Indicator
Table 2 Torque Screw Line Indicator/Clamping Force
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 range reaching 80 lbs. (356 N) is available if desired.
7. Once the force is applied to the clamp and the patient is positioned for surgery, the Index
Locking Knob should be turned to the locked position shown in Figure 4.
WARNING!
Never exceed 80 lbs. (356 N) of force.
CAUTION!
Over-tightening the Index Locking Knob can result in damage to the skull clamp.
Figure 7 Standard Torque Screw

Page 10
Aachment of The Skull Clamp to The Base Unit
Once the Skull Clamp is applied to the patient’s skull, the surgeon will maneuver the patient to the
surgical position that is required for the procedure. With the patient in this position, the surgeon will
hold the patient’s head and the Skull Clamp and request that the components for the Base Unit to be
brought up for aachment.
1. The MAYFIELD 2 Base Unit (A3100, A3101, A3102), should be aached to the operating room
table with the Locking Handle unlocked and the Swivel Adaptor loose. In the event that other
MAYFIELD Base Units (A2009, A2101, A2001, A1001, A1000) are going to be used with the Skull
Clamp, be sure to also assemble a Swivel Adaptor (A1018, A2008) to complete the support
system for the Skull Clamp. Make certain to securely aach the base unit to the operating room
table.
2. The aached but loose components of the Base Unit should be brought up for aachment to
the Skull Clamp.
• Insert the mounting screw of the large starburst of the Swivel Adaptor into the large starburst
of the Skull Clamp.
• Turn the handle clockwise and tighten.
• Care should be taken to maintain the position of the patient’s head as requested by the surgeon.
3. Aer securely fastening the Skull Clamp to the Swivel Adaptor turn the Index Locking Knob
to the locked position. Continue by checking all the locking knobs and locking handles of the
Adaptor and Base Unit making certain all starburst teeth are meshed (where applicable) on all
joints of the Base Unit aer adjustments are complete.

Page 11
CAUTION!
Before fully tightening, always be certain that the starburst teeth of the Swivel
Adaptor and the Transitional Member fiings are the same size and properly mesh.
Failure to do so may damage fiings. Figure 8 shows a typical starburst connection
and proper meshing of teeth.
Proper Meshing
of Teeth
Figure 8 Mounting Skull Clamp
Service Notes
A routine equipment inspection made well before each case will help avoid problems. This check
should include the following:
1. Store the Skull Clamp with the Index Locking Knob in the UNLOCKED position. This practice
will provide the best performance from the knob.
2. While rotating the rocker arm through 360 degrees, lock and unlock the Index Locking Knob.
To ensure proper locking engagement, the Index Locking knob must always be turned to the
lock position. If the Index Locking Knob stops short of the locked position, a slight additional
rotation of the rocker arm should complete the internal alignment and allow the locking
mechanism to engage. If difficulties are encountered, the unit should be returned for service.
3. Check the Ratchet Extension release buons to be sure that they allow for the Extension to
disengage freely. Press them and move the Extension out of the body portion of the clamp - do
this several times to make sure that it works smoothly and easily.

Page 12
Cleaning of the MAYFIELD 2 Skull Clamp
CAUTION!
Care should be taken to read completely this section on Cleaning, Disinfection
and Decontamination of your MAYFIELD 2 equipment. It is important to know
what method of cleaning/decontamination is needed based on what type of debris
exposure the equipment has received. This is especially important when there is the
possibility of exposure to a persistent pathogen that is resistant to normal cleaning
and disinfection methods. Equipment with this exposure should be processed
per the steps in the Decontamination Section. Integra does not make any claims
regarding the effectiveness of the decontamination processes listed in deactivating
pathogens, but rather, we are indicating that the device can withstand these
procedures with minimal loss of function.
The MAYFIELD 2 Skull Clamp must be thoroughly cleaned aer each use. Scrub each component
with a so brush. The Skull Clamp can withstand detergents that fall within pH ranges of 3-11. The
directions for use for the selected detergent should be followed for this device. Clean thoroughly to
remove any traces of blood and/or debris and to prevent such blood or debris from interfering with
function or movement. Repeating this washing process is recommended until the device is visibly
clean. Rinse thoroughly with clean water to remove all traces of detergent.
NOTE: The use of highly alkaline agents may cause some components to tarnish and/or corrode. While
this does not affect the performance of the device we recommend that you use an acidic neutralizing
agent immediately aer each use as this will help keep your device looking like new.
Manual Cleaning
Following these steps is recommended:
1. Separate the Ratchet Extension from the body portion of the Skull Clamp.
CAUTION!
Visually confirm that there are no Skull Pins in the rocker arm or Torque Screw. It is
recommended to completely remove the ratchet extension from the clamp before
removing Skull Pins.
2. Remove the Torque Screw from the Ratchet Extension.
3. Wash and rinse all parts as indicated above.
4. Dry all components with a so dry towel.
5. Aer components are totally dry, re-assemble the components, leaving the Skull Clamp ready
for its next use.
• The Index Knob should be in the UNLOCKED position.
• The Torque Screw should be inserted with the first thread showing.
• The Ratchet Extension should be inserted into the body portion of the Skull Clamp.

Page 13
Optional Automatic Wash Cycle:
CAUTION!
Any deviation from this guideline could result in damage to equipment as well as
improper cleaning results.
• Disassemble the device as indicated in section Cleaning of the MAYFIELD 2 Skull Clamp.
• Rinse components under warm tap water prior to placing in washer.
• Arrange device in a way to avoid contact between components.
• Select instrument cycle and ensure proper programming.
Phase Time in minutes Water
Temperature
Detergent type &
Concentration
Pre-Wash 1 04:00 Cold tap H2O
Enzyme Wash
Wash 1
Rinse 1
Thermal Rinse**
10:00
04:00
02:00
00:30
Hot tap H2O
60° C
82.2° C
Hot tap H2O*
Endozime® AW
Triple plus w/
A.P.A., 1:128 ratio
Renu-Klenz™,
1:256 ratio
N/A
N/A
N/A
Table 3 Instrument Cycle
• Remove from washer and dry completely if needed.
• Inspect all components to ensure there is no visible organic debris or residue from cleaning
agent. Repeat process if any visible soil is detected.
(For additionally validated cleaning cycles, refer to Appendix A)
* No limit on tap water temperature
** Optional phase for disinfection of components - minimum water temperature as indicated or
per washer manufacturer specifications for the thermal rinse cycle

Page 14
Disinfection
The MAYFIELD 2 Skull Clamp must be thoroughly cleaned aer each use. Where possible, keep the
soiled areas moist until the disinfection process can be initiated.
IMPORTANT: If the product has been exposed to persistent pathogens1, do not apply gluteraldehyde,
alcohol or formalin to the device until the decontamination process is complete. Aer
decontamination, normal cleaning processes can be employed (see Decontamination section).
1. Remove Ratchet Extension from the Clamp Base (see Figure 5).
• Visually confirm there are no skull pins in the Rocker Arm or Torque Screw sockets.
2. Remove skull pins if present.
3. Remove gross debris and soil from the Skull Clamp components.
4. Remove Torque Screw from Ratchet Extension.
Disinfection of device components following normal usage may be achieved using the following
methods:
Method 1: Thermal Rinse
• A Thermal Disinfection rinse may be added aer the first rinse cycle as indicated in Table 3.
Method 2: Chemical
• Prepare a fresh solution for general disinfection (See Table 4 guidelines for bleach solution).
• With the device disassembled, place parts in a shallow pan and add enough general disinfection
solution to cover the device completely.
• Allow the parts to soak for 15 minutes.
• Rinse thoroughly with clean water.
· Verify concentration of base hypochlorite is 4.5% or more
·Mix 1/2 unit of bleach into 10 units of water.
For General Disinfection
Table 4 Hypochlorite Bleach Mixing Guidelines
1. Persistent pathogens are resistant to deactivation by normal disinfection procedures and may require more
aggressive treatment to achieve disinfection. See guidelines in Decontamination section for recommended
procedures.

Page 15
Disinfection (Continued)
Method 3: Autoclave
• With device cleaned and disassembled, wrap components to keep clean.
• Time and temperature parameters vary widely according to the type of autoclave and packaging
material. Follow manufacturer’s instructions for loading and operating the autoclave.
• Make sure direct steam exposure to all surfaces is possible.
• Pre cycle vacuum (2psia / 14kPa) then steam disinfect at 132°C to 134°C for 4 minutes.
• Once device is removed from the autoclave, allow components to reach room temperature
before reassembly, handling, storage or use.
• Following the disinfection procedure, subject to routine cleaning (see Cleaning section).

Page 16
Decontamination:
When the MAYFIELD 2 Skull Clamp has been exposed to pathogens that resist normal disinfection
methods, the product should be handled more carefully:
• Wear appropriate personal protective equipment (eye/face protection, gloves)
• Keep soiled areas of the device moist. Do not apply gluteraldehyde, alcohol or formalin to the
device until the decontamination process is complete.
NOTE: Do not subject the Skull Clamp to automated cleaning processes until aer the
decontamination procedure.
1. Remove Ratchet Extension from the Clamp Base (see Figure 5).
• Visually confirm there are no skull pins in the Rocker Arm or Torque Screw sockets.
2. Remove and dispose of skull pins if present.
3. Remove gross debris and soil from the clamp components using so cloth or paper towels.
Minimize formation of aerosols or droplets during the initial preparation of the product for
decontamination.
4. Remove Torque Screw from Ratchet Extension.
5. Place parts in a shallow pan and add enough chlorine solution2to cover the device completely.
• Allow to soak for 60 minutes.
6. Remove the device from the bleach solution and rinse components completely with water.
• The Skull Clamp may then be autoclaved at 134 degrees C for 18 minutes to one hour.
• The Skull Clamp has been verified through testing to withstand this process up to 15 times
without loss of performance.
NOTE: Integra makes no claims that the following protocol is effective in neutralizing any specific
pathogens.
World Health Organization (WHO) Protocol for Decontamination of highly infectious diseases3:
“Immerse [instrument] in sodium hypochlorite for 1 hour; remove and rinse with water, then transfer to
open pan and heat in a gravity displacement autoclave at (121° C) or porous load (134°C) for 1 hour.”
2. Recommended concentration is 20,000 ppm available chlorine. See Bleach Dilution section.
3. WHO/CDS/CSR/APH/2000.3, “WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies”, (Switzerland, March 1999) pp 29

Page 17
Bleach Dilution:
CAUTION!
Caution: Bleach solutions produce chlorine gas. Prepare in a well ventilated area.
NOTE: Hypochlorite potency decreases as bleach ages. Use only recently purchased bleach to prepare
decontamination solutions. Do not use pre-diluted bleach. Prepare a fresh batch for each application.
Hypochlorite bleach mixing guidelines to obtain 20,000 ppm solution:
Bleach
Concentration Preparation Instructions
4.5%
5%
6%
Pour 4 units bleach into 5 units water
Pour 2 units bleach into 3 units water
Pour 1 unit bleach into 2 units water
Table 5 Hypochlorite Bleach Mixing Guidelines.
NOTE: The use of highly alkaline agents may cause some components to tarnish and/or corrode.
While this does not affect the performance of the device we recommend that you use an acidic
neutralizing agent immediately aer each use as this will help keep your device looking like new.
Maintenance and Care
The MAYFIELD 2 Skull Clamp should be returned to its storage area aer each use whether it be a
designated OR or equipment room.
NOTE: Ensure all components are completely dried aer each cleaning.
CAUTION!
If the Skull Clamp is dropped or mishandled, it should be inspected for damage.
(REF Inspection section of this Instruction manual). If damage occurs, do NOT use;
return the complete device immediately to Integra LifeSciences for inspection.
NOTE: Follow hospital procedures for disposal of this device.

Page 18
APPENDIX A
Additionally Validated Cleaning Cycles
(Pre-Wash) Wash (Rinsing) Thermal
Disinfection
(Drying)
(Optional)
Temperature Hold Time Detergent
Treatment
Cold water from
building supply
(less than 110°
or 43°C)/4 min.
93°C 1 or more
min.
Alkaline (e.g.
neodisher®
SeptoClean 1%)
Hot water
from building
supply/2 min.
Optional 90°C/2o min.
50°C/7 min 90°C1 or more
min.
Neutral
Enzymatic
(e.g. Enzol® per
manufacturer’s
recommendation)
Hot water
from building
supply/2 min.
Optional 90°C / 20 min.