Integra MAYFIELD 2 A3100 User manual

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MAYFIELD®2 Base Unit
(A3100, 3101, 3102)
Instruction Manual
EN – ENGLISH ...................................2
FR – FRANÇAIS ................................ 24
IT – ITALIANO ................................. 48
DE – DEUTSCH ................................ 72
ES – ESPAÑOL .................................96
NL – NEDERLANDS ........................... 120

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Indications For Use
The MAYFIELD® 2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical
procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is
required.
Failure to read and follow instructions and warnings 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.
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.
Monopolar electrosurgical equipment with operational voltages that exceed 3000 V may result in patient harm when this
system is used in conjunction with a skull clamp.
The user must make sure that any threaded connections are secure and starbursts have meshed (where applicable) after
adjustments are complete. Failure to do so may result in serious patient injury.
Always make sure the base unit is properly secured to the operating table. The base unit must not be used if the device
appears to be damaged or functioning incorrectly.
Do not use any tools on this equipment to secure. Over-tightening any of the adjustment screws or knobs may result in
damage to the unit. If unit does not appear secure after hand-tightening, do not use the unit and contact your MAYFIELD
Representative or the MAYFIELD Service Team.
Over-extending or overloading the base unit may result in unintended movement, shortened product life and/or damage to the
unit.
Do not alter the construction of this device as it may result in serious patient injury.
Not all MAYFIELD products can be cleaned and decontaminated in the same manner as those labeled as MAYFIELD 2.
Consult the individual instructions for use (for each device) on the proper care and cleaning procedures.
0123
Conforms to the European Medical Device Directive (MDD).
EC REP
Authorized EC Representative in the European Community.
Attention, consult accompanying documents
REF
Product catalog number
Manufacturer
Caution: Federal (USA) Law restricts this Device to sale by or on the order of a Licensed practitioner.
This device is not indicated for use in MR environment.
Symbols used on Labeling
WARNING!
CAUTION
CAUTION!
Hazards which could result in equipment or property damage.
WARNING!
Hazards which could result in personal injury or death

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Description
The MAYFIELD 2 Base Unit (REF A3101, A3102, A3100) is designed to provide attachment from the operating room table to
MAYFIELD Skull Clamps for rigid skeletal fixation or MAYFIELD Horseshoe Headrests for procedures where support only, and
not rigid fixation, is required. The MAYFIELD 2 Base Unit is designed for patient positioning in the prone, supine lateral or
park-bench and sitting positions. The Support Rod spacing may be readily adjusted to fit most operating room tables. No
tools are required. See Attachment to Operating Room Table for instructions to adjust the Support Rods.
MAYFIELD 2 Base Unit, Standard A3101 MAYFIELD 2 Base Unit, Narrow A3100
MAYFIELD 2 Base Unit, International A3102
Figure 1 MAYFIELD 2 Base Unit Catalog Numbers
A Standard MAYFIELD 2 Swivel Adaptor (A3018) is an integral component of the Base Unit. A separate, optional MAYFIELD 2
Tri-Star Swivel Adaptor (A3008) is available as an accessory product when image-guided surgery (IGS) systems are used in the
procedures. The Tri-Star Swivel Adaptor provides two extra starbursts for attachment of the ancillary IGS equipment.
Each MAYFIELD 2 Base Unit purchased (A3100, A3101, or A3102) includes:
1- MAYFIELD 2 Base Unit
1- MAYFIELD 2 Swivel Adaptor (A3018)
OPTIONAL: MAYFIELD 2 Tri-Star Swivel Adaptor (A3008)

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1. Transitional
2. Locking Lever
3. Latch
4. Base Handle Assembly
Figure 2B MAYFIELD 2 Base Handle Components
Figure 2A MAYFIELD 2 Base Unit Components
1. Left Bracket
2. Left Bracket Lock Knob
3. Connecting Tube
4. Base Handle Assembly
5. Locking Lever
6. Transitional
7. Swivel Lock Knob
8. Swvel Adaptor (A3018)
9. Headrest Lock Knob
10. Right Bracket

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The MAYFIELD 2 Base Unit is designed for use with the following equipment:
A1008 MAYFIELD General Purpose Headrest
A1011 MAYFIELD Horseshoe Headrest*
A1012 MAYFIELD Adult Horseshoe Headrest
A1015 MAYFIELD Crossbar Adaptor**
A1031 MAYFIELD (A&B) NeuroGen Adaptor
A1051 MAYFIELD Pediatric Horseshoe Headrest*
A1059 Modified MAYFIELD Skull Clamp
A1073 Posterior Cervical Support
A1108 MAYFIELD Triad Skull Clamp
A1109 MAYFIELD Horseshoe Conversion Adaptor
A1112 MAYFIELD Infinity Support System
A1113 NeuroGen Adaptor
A1114 MAYFIELD Infinity Skull Clamp
A1114A MAYFIELD Infinity Skull Clamp
A2000 MAYFIELD 2000 Skull Clamp
A3059 MAYFIELD 2 Skull Clamp
*A1109 MAYFIELD Headrest Conversion Adaptor is required for use
**A1060 Universal Side Rail Fittings is required for use
Note: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s stabilization equipment is not
recommended.
Figure 3 OPTIONAL MAYFIELD 2 Tri-Star Swivel Adaptor (A3008)

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Inspection
Always inspect MAYFIELD equipment 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.
Care and Maintenance
Your Integra representative will regularly perform a comprehensive inspection of your MAYFIELD equipment. In addition,
to ensure that factory-set calibrations remain in good working order, a Preventative Maintenance is required yearly at the
Integra authorized Service & Repair Center. Integra will do its best to provide comparable Service loaner equipment while
your MAYFIELD undergoes this required yearly maintenance.
To ensure proper function and to extend the life and performance of the equipment, Integra LifeSciences requires the
following:
Required Action Required Frequency
Return the device to the Integra LifeSciences Repairs department for detailed inspection
and servicing. Once / year
Request that Integra NeuroSpecialists perform routine inspections of the device Twice / year
In the absence of proper care and servicing of the device, negative effects may be seen after repeated processing over time
which may lead to reduced performance.
Contact information: See the Service and Repair section for contact information on how to return your device for periodic
servicing and to request periodic inspections.
Device Disposal
NOTE: Follow hospital procedures for disposal of this device.
CAUTION!
If unit 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 for inspection.

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Directions for Use
Attachment of the Base Unit to Operating Room Table:
MAYFIELD 2 Base Unit (3100) Le Bracket may be adjusted along the Connecting Tube to allow the Support Rod to
accommodate table receptacles spaced 4-1/2” to 8-1/4” (114mm to 209.5mm) apart.
MAYFIELD 2 Base Unit (3101) Le Bracket may be adjusted along the Connecting Tube to allow the Support Rod to
accommodate table receptacles spaced 5-1/8” to 8-1/4” (130mm to 209.5mm) apart.
MAYFIELD 2 Base Unit (3102) Le Bracket may be adjusted along the Connecting Tube to allow the Support Rod to
accommodate table receptacles spaced 6-5/8” to 15-3/4” (168mm to 400mm) apart.
1. Locate and loosen the Left Bracket Lock Knob on the backside (See Figure 4) of the Left Bracket and slide the Left Bracket
smoothly along the the Connecting Tube until the desired width between the Support Rods is achieved.
2. Mount the Base Unit to the operating room table by aligning the two Support Rods with receptacles at the head end of
the Operating Room table, or, in the NeuroGen Adaptor or Crossbar Adaptor.
3. Tighten the Left Bracket Lock Knob to secure the Left Bracket into position.
4. Secure the Base Unit Support Rods to the table by tightening the table lock knobs or the knobs on the NeuroGen
Adaptor or Crossbar Adaptor.
Figure 4 Le Bracket Lock Knob
Clockwise rotation to tighten
Le bracket lock knob
CAUTION!
Do NOT use any tools to tighten any knobs on this device. All knobs should be hand tightened only. Use caution not to over-
tighten. Over-tightening may damage the device.

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Attachment of the Swivel Adaptor (A3018 or A3008) to the Base Unit
Insert screw of Swivel Adaptor into clover-shaped Swivel Lock Knob at the end of the transitional arm. Tighten by turning
Swivel Lock Knob clockwise and ensure that all starburst teeth are meshed. Do not over-tighten. No tools should be used to
attach or remove the Swivel Adaptor from the Base Unit.
Transitional
Starburst Teeth
Swivel Lock Knob
Swivel
Figure 5 Aachment of Swivel Adaptor
Figure 6 Stability Check
CAUTION!
Confirm the Base Unit stability by positioning (connected to operating table) the components as shown in Figure 6. Exert
moderate force against the Swivel Adaptor in the indicated direction shown by arrow 2 in Figure 6. No movement should be
observed at any of the joints. If movement is observed, do not use product and contact your MAYFIELD Representative or the
MAYFIELD Service Team.

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Figure 7 Handle Self-Latching Feature
Positioning the Transitional Arm and Swivel Adaptor
The handle is equipped with a self-latching feature. To free the Locking Lever, press the latch into the Locking Lever, the
lever will move away from its closed position.
Latch