Integra MAYFIELD 2 A3100, Instruction Manual

Page: 3 / 143

EN – ENGLISH
2
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