Integra MAYFIELD A1121 User manual

MAYFIELD® Reusable
Titanium Skull Pin, Adult
( A1121)
MAYFIELD® Reusable
Titanium Skull Pin, Child
( A1122)
Instruction Manual
Manufacturer:
Integra LifeSciences Corporation
 Charlemar Drive, Building A
Cincinnati, OH , USA
Tel: 
Fax: 
integralife.com
Integra LifeSciences Services
Immeuble Séquoïa 2
 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
 Saint Priest, FRANCE
Phone: + ()    

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English – EN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Français – FR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Italiano – IT ..................................................25
Deutsch – DE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Español – ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Nederlands – NL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

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English–EN
Authorized Representative in the European
Community
Catalog number
Caution: Federal (US) law restricts this device to
sale by or on the order of a licensed healthcare
practitioner
Caution, consult accompanying documents
Manufacturer
Product complies with the requirements of
directive 93/42/EEC
MR conditional
Lot Number
Date of manufacture (YYYY-MM-DD)
Consult Instructions for Use
Meaning Of Symbols Used In This Manual - ENGLISH
Hazards which could result in equipment or property damage
Hazards which could result in severe personal injury or death
WARNING!
CAUTION!

5
English–EN
ENGLISH
Indication For Use:
The MAYFIELD® Reusable Titanium Skull Pins (REF A1121, A1122) are
intended for use with a MAYFIELD skull clamp that is placed on the
patient’s skull to hold their head and neck in a particular position
during surgical procedures where rigid skeletal fixation is desired and
intra-operative MR imaging is used.
The MAYFIELD Reusable Titanium Skull Pins (REF A1121, A1122) are
indicated for use in open and percutaneous craniotomies and spinal
surgeries when rigid skeletal fixation is necessary and when intra-
operative MR imaging of the patient is used.
Description
The MAYFIELD Reusable Titanium Skull Pins (REF A1121, A1122) are
used in conjunction with MAYFIELD brand Radiolucent Skull Clamps
(REF A1117, A2002 or A2006). The reusable skull pins are supplied
non-sterile and must be sterilized before each use.
The titanium pin will produce artifact similar to a steel pin if used
during X-Ray or CT imaging. Use MAYFIELD Radiolucent Skull pins
(A2020) to minimize artifact in X-Ray or CT modalities.
Figure 1
This device is MR Conditional* according to terminology specified in
the American Society for Testing and Materials (ASTM) International,
Designation: F2503-05.
*See Table 1 for conditions.
Table 1
Non clinical testing demonstrated that the Reusable Titanium
Skull pin is “MR Conditional”. A patient may be scanned under
these conditions:
Static Magnetic field Strength ≤ 3.0 Tesla (T)
Spatial gradient magnetic field ≤ 720-Gauss/cm
Maximum MR system reported whole-body-averaged specific
absorption rate (SAR): 3-W/kg for 15 min scan
In non clinical testing, the Reusable Skull Pin produced a
temperature rise of ≤ 0.4 °C at a maximum MR system reported
whole-body-averaged specific absorption rate (SAR) of 3-W/
kg for 15 minutes of scanning in a 3-Tesla MR system using a
transmit/receive body coil (Excite, Soware G3.0-052B, General
Electric Healthcare, Milwaukee, WI)
MR image quality may be compromised if the area of interest
is in close proximity to the position of the Reusable Skull Pin.
Optimization of MR imaging parameters may be necessary.

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English–EN
Inspection
Always inspect pins carefully under a strong light source before
and aer each use. Pin points must be sharp and straight. O-rings
must be smooth and free of tears. If an instrument appears damaged
and/or does not seem to function properly, immediately send the
instrument for repair or replacement. This will prevent increasing
operative time and needless endangerment to the patient’s life.
WARNINGS:
Failure to read and follow instructions and warning furnished
in this instruction manual and the instructions and warnings
included in the associated skull clamp instruction manual may result
in skull pin slippage and serious patient injury, such as scalp
lacerations, skull fracture, or even death.
The skull clamp must be applied along a centerline of the
patient’s head with pins entering the skull perpendicularly.
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 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
lacerations, skull fracture, or even death.
Do not use the MAYFIELD Titanium Skull Pins with the
Original GARDNER brand Skull Clamp.
These 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
Titanium Child Skull Pins (A1122) 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.
These pins are provided non-sterile. The reusable skull pins
should be steam sterilized before each use. It is
recommended that a second set of sterile pins be kept available in
case sterile technique is compromised.
Never resharpen skull pins. Dull or bent pins should be
discarded and replaced.
Do not confuse titanium skull pins with steel pins. Steel
objects passing through high intensity magnetic fields can
generate enough heat to burn tissue. The adult titanium skull pin
has been colored “gold” and the cylindrical portion of the body has
several flat surfaces to be used as visual cues that the pin is made of
titanium. Child pins have a unique shape to make them readily
distinguishable from the adult pin points (Figure 2):
Figure 2
Gold color and facets
indicate titanium pins
The child pin has a
unique profile
Adult Titanium Reusable
Skull Pin
Child Titanium Reusable
Skull Pin

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English–EN
Instructions for Mounting Skull Pins
WARNING:
Before using this product, carefully read the product insert
for correct use and warnings associated with the specific skull clamp
model intended to be used.
CAUTION:
Inspect reusable skull pin points carefully prior to each use.
To achieve proper fixation, pins should be of equal length. Broken,
dull or bent pins should be replaced. It is recommended that a spare
set of pins always be kept available.
1. Hold the skull pins between the thumb and the forefinger at the
base of the pin.
2. Insert the pins into the skull pin receptacles on the skull clamp.
Push them in until they are seated firmly and cannot be inserted
any further into the receptacle.
CAUTION:
The skull pins must be fully seated so there is no gap between
the shoulder of the skull pin and the skull clamp (Figure 3).
Figure 3
Correctly
Seated
Incorrectly
Seated
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 (Figure 4).
Figure 4
Poor centerline placement
Good centerline placement
WARNING:
Do not position the skull pins over the frontal sinuses of the
temporal area of the skull. Take care to avoid major blood vessels,
nerves, previously restored or abnormally thin bone.
CAUTION:
Skull Pins should enter the scalp at a 90° angle.
CAUTION:
60 lb. (267 N) of force is recommended for adults. 40 lb. (178
N) of force is recommended for children. All force seings are at the
user’s discretion. Never exceed 80 lb. (356 N) of force.

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English–EN
Removal of Skull Pins
CAUTION:
Remove single-pin holder or skull clamp extension from skull
clamp prior to skull pin removal. This will minimize chance of injury
during skull pin removal
1. Grasp skull pin base between thumb and forefinger.
2. Pull skull pin outward and away from the receptacle.
Care and Cleaning:
Manual Wash
CAUTIONS
• Alkaline and highly acidic detergents and solutions cause damage
to the devices.
• Channels and crevices found on this device require particular
aention during cleaning.
• Pay special aention to the water quality used throughout
reprocessing. Hard water can damage the surface of the
equipment. Avoid using hard water. Instead use purified water
unless otherwise specified.
Limitations on reprocessing
• Repeated processing has minimal effects on these devices. Product
life is normally determined by wear and damage due to use.
• It is important to have Integra NeuroSpecialists perform routine
inspections. See contact information below.
INSTRUCTIONS
Containment/Transportation
• Follow health care facility protocol for safe containment and
transport to the decontamination environment.
• It is recommended that devices are cleaned immediately aer use.
Preparation for Cleaning
Disassembling Equipment Inspecting for Cleanliness
Ring is in place and intact.
Look for bent or hooked
pin points.
Inspect reusable pin closely for
any sign of visible organic debris.
Cleaning – Manual Equipment: Water, Neutral pH Detergent, So
Bristle Brush, Towels
Method
1. Prepare neutral pH enzymatic detergent solution (e.g. Endozime®
AW Triple Plus with APA (Ruhof), 1:128 ratio) according to
detergent manufacturer’s instructions using lukewarm tap water.
2. Prepare equipment for soaking by disassembling removable parts
and loosening connections.
3. Rinse equipment in warm water before placing into bath.
4. Completely soak equipment in water/detergent solution for 30
minutes maximum.
5. Clean thoroughly with a so nylon bristle brush. NOTE – If
possible, use a disposable brush.
6. Rinse in warm purified water until all visible substances and
residual detergent are removed. NOTE – Make sure to give special
aention to hard-to-reach areas.

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English–EN
7. Thoroughly dry equipment with so clean towels and use
medically compressed air if needed, to dry channels, crevices and
lumens.
8. Inspect the equipment to make sure there is no visible organic
debris or residue from cleaning agent.
Repeat process if any soil is detected.
Drying
• Products should be dry at this point. If wetness or excess liquid is
detected, dry with a so clean towel.
• Medically compressed air can be used if needed.
Optional Automatic Wash / Disinfect
CAUTIONS
• Alkaline and highly acidic detergents and solutions cause damage
to the devices.
• Channels and crevices found on these devices require particular
aention during cleaning.
• Pay special aention to the water quality used throughout
reprocessing. Hard water can damage the surface of the
equipment. Avoid using hard water. Instead use purified water
unless otherwise specified.
Limitations on Reprocessing
• Repeated processing has negative effects on these devices and is
not recommended for routine use.
• It is important to have Integra NeuroSpecialists perform routine
inspections. See contact information.
INSTRUCTIONS
Cleaning - Automated Equipment: Neutral pH Detergent
Method
1. Prepare equipment for cleaning by disassembling removable parts
and loosening connections.
2. Rinse equipment in warm water before placing into washer.
3. Load device into the washer and place small parts in container
or tray inside the washer unit in order to avoid loosing small
components.
4. Follow the instructions listed below and set washer machine to
these exact parameters:
Phase Time
(Min.)
Water
Temperature
Detergent and
Concentration
Pre-wash 1 4:00 Cold water N/A
Enzyme
Wash 4:00 Hot water
Neutral pH
enzymatic (e.g.
Endozime® AW
Triple Plus with
APA, Ratio 1:128)
Wash 1 10:00 60.0ºC
(140º F)
Neutral pH
detergent
(e.g. Renu-Klenz™ ,
Steris, Ratio 1:256)

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English–EN
Phase Time
(Min.)
Water Tem-
perature
Detergent and
Concentration
Rinse 1 0:30 Hot water N/A
Thermal
Rinse** 2:00 82.2ºC
(180º F) N/A
** Optional phase for disinfection of components – minimum water
temperature as indicated or per worker manufacturer specifications
for the thermal rinse cycle.
NOTE – Any deviation from this guideline could result in damage to
the equipment as well as improper cleaning results.
Rinse with purified water. Do not perform if parameters cannot be
achieved.
1. Remove from washer and dry completely if needed.
2. Inspect equipment to make sure there is no visible organic debris
or residue from cleaning agent.
Repeat process if any visible soil is detected.
NOTE: These pins are supplied non-sterile and must be sterilized
prior to each use.
Sterilization
Inspect pins carefully under a strong light source. Pin points must
be sharp and straight. O-rings must be smooth and free of tears.
Remove damaged pins from service.
Other time and steam temperature cycles may also be used; however,
the user must validate any deviation from the recommended time
and temperature. Follow the sterilizer manufacturer’s instruction for
operation and loading of the steam autoclave.
Cycle Pre-vacuum
Preconditioning Pulses: 3
Temperature: 132°C (min)
Duration: 3 minutes
Dry time: 5 minutes