Integra MAYFIELD 2 A3100, MAYFIELD 2 A3101, MAYFIELD 2 A3102 Instruction Manual
MAYFIELD® 2 Base Unit
(A3100, 3101, 3102)
EN – ENGLISH
Instruction Manual
EN – ENGLISH ...................................2
FR – FRANÇAIS ................................ 24
IT – ITALIANO ................................. 48
DE – DEUTSCH ................................ 72
ES – ESPAÑOL .................................96
NL – NEDERLANDS ........................... 120
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EN – ENGLISH
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0123
Symbols used on Labeling
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CAUTION
Hazards which could result in equipment or property damage.
WARNING!
Hazards which could result in personal injury or death
EC REP
REF
Conforms to the European Medical Device Directive (MDD).
Authorized EC Representative in the European Community.
Attention, consult accompanying documents
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.
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.
WARNING!
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.
CAUTION!
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.
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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. Left Bracket
2. Left Bracket Lock Knob
3. Connecting Tube
4. Base Handle Assembly
5. Locking Lever
6. Transitional
7. Swivel Lock Knob
8. Swvel Adaptor (A3018)
9. Headrest Lock Knob
10. Right Bracket
EN – ENGLISH
1. Transitional
2. Locking Lever
3. Latch
4. Base Handle Assembly
Figure 2A MAYFIELD 2 Base Unit Components
Figure 2B MAYFIELD 2 Base Handle Components
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Figure 3 OPTIONAL MAYFIELD 2 Tri-Star Swivel Adaptor (A3008)
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.
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Inspection
Always inspect MAYFIELD equipment before and aer 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.
Request that Integra NeuroSpecialists perform routine inspections of the device
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.
Once / year
Twice / year
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.
CAUTION!
Do NOT use any tools to tighten any knobs on this device. All knobs should be hand tightened only. Use caution not to overtighten. Over-tightening may damage the device.
Le bracket lock knob
Clockwise rotation to tighten
Figure 4 Le Bracket Lock Knob
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.
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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.
Swivel
Swivel Lock Knob
Starburst Teeth
Transitional
Figure 5 Aachment of Swivel Adaptor
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.
Figure 6 Stability Check
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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
Figure 7 Handle Self-Latching Feature
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1. Open the Locking Lever to position the Transitional Arm as desired. The Locking Lever must be in the fully opened
position to perform free movement of the Transitional Arm.
Figure 8 Open Locking Lever
2. 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 Transitional Arm be brought up to the proper height for attachment of the Skull
Clamp to the Swivel Adaptor.
a) Once the Transitional Arm is at the proper height for attachment to the Skull Clamp, the mounting screw of the
large starburst on the Swivel Adaptor should be inserted into the large starburst of the Skull Clamp and turned
clockwise
and tightened. Care should be taken to maintain the position of the patient’s head as requested by the surgeon.
b) Ensure that the Skull Clamp is securely attached to the Swivel Adaptor by turning the mounting screw on the top
of the Swivel Adaptor clockwise to tighten (Figure 9A). Close the Locking Lever. Make certain that all starburst
teeth are fully meshed (where applicable) on all joints of the Base Unit after adjustments are complete.
(See Figure 9B)
Proper Meshing of Teeth (3x)
Figure 9B Proper meshing of Starburst TeethFigure 9A Attachment of Skull Clamp
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CAUTION!
Before fully tightening, always be certain that the starburst teeth of the Swivel Adaptor and other starburst fittings are the
same size and properly mesh. Failure to do so may damage fittings and/or allow unwanted movement of the patient. Figure
10 shows a typical starburst connection and proper meshing of teeth. (See Figures 10A and 10B)
Proper Meshing of Teeth
Figure 10A Proper Meshing of Teeth
Figure 10B Improper Meshing of Teeth
Improper Meshing of Teeth
(If aaching a Horseshoe Headrest, bring the Transitional Arm to the proper height. The mounting screw of the large
starburst on the Swivel Adaptor should be inserted into the large starburst of either the Horseshoe Headrest or the
Conversion Adaptor if used. Turn mounting screw on the top of the Swivel Adaptor clockwise to tighten.)
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CAUTION!
Keep fingers clear of hinge points when closing the Base Unit Locking Lever. See Figure 11 below. It is recommended that the
levers be closed using the palm of the hand.
Figure 11 Locking Mechanism
CAUTION!
Always be sure the locking mechanisms are secure after completing table adjustments. Verify that the Transitional Arm is
secured in place by confirming that the Locking Lever is engaged. Lift up on the Locking Lever WITHOUT depressing the
Latch. The Locking Lever should not be free to open.
Figure 12 Securing Locking Lever
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Cleaning of the MAYFIELD 2 Base Unit
These instructions are the recommendation of the manufacturer to ensure proper function and to extend the life and
performance of the equipment. As the equipment is reprocessed over time, many factors, including water quality used,
frequency of inspections and servicing, and method of reprocessing may impact the long term performance of the
equipment. Manual cleaning has been shown to exhibit the least amount of degradation of device performance over time,
and is therefore the recommended method of reprocessing to extend the long term performance of the equipment. The
equipment may also be reprocessed by automated cleaning and disinfection per the instructions contained in this section.
No degradation of product performance is anticipated given the device is properly cared for as recommended by the
manufacturer. This care includes inspections and periodic servicing, and avoidance of hard water where recommended. In
the absence of proper care and servicing, negative effects may be seen after repeated processing over time which may lead to
reduced performance.
Considerations:
• Follow the instructions exactly as listed in this Instruction Manual and your Hospitals procedures for
decontamination, cleaning and to reprocess medical instruments safely.
• 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 Highly
Infectious Diseases.
• This protocol has been validated for cleaning effectiveness only.
• Refer to the User Manual to disassemble the product before cleaning .
• Refer to the User Manual for further details on product use and set-up.
• The user should comply with hospital procedures and local laws and ordinances regarding reprocessing
requirements.
• Hospitals are responsible for decontaminating and packaging all loaner and demo equipment before returning to
Integra.
• 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.
• Please clean product using these guidelines prior to first use.
Warnings:
• Take all necessary precautions in wearing the appropriate protective equipment (eye/face, protection, gloves as
specified in the instructions provided by the cleaning agent. Clean device immediately aer each use.
• 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 aer each use
to avoid the occurrence of cosmetic changes.
• Follow all instructions of the detergent, equipment washer, and autoclave manufacturer.
• Follow the detergent concentration, temperature, exposure time, material compatibility specifications, and disposal
directions of the cleaning agent as recommended by the manufacturer.
• Use only the cleaning tools mentioned in this manual. Never use metal brushes.
• Failure to follow the instructions of this document could result in damage to the equipment.
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MAYFIELD 2 Base Unit - A3101 (Including A3018 Swivel Adaptor)
Preparation for Cleaning and Reassembly
1. Remove skull clamp from the base unit.
2. Remove base unit from the operating room table.
Disassembly Inspecting for cleanliness Reassembly
1– Remove swivel adaptor (1) from the base
unit (2).
2– Keep base unit (2) in the UNLOCKED
position before cleaning.
3– Do not attempt to disassamble further.
Pay close attention to:
1– Area around the locking mechanism
(3).
2– Teeth of the starburst (both sides)
(4) .
EN – ENGLISH
1– Tighten swivel adaptor (1) to the
base unit (2).
2– Store the base unit (2) with the
locking handle (5) in the closed
position.
(1) swivel adaptor
(3) locking mechanism
(4) teeth
(2) base unit
(5) locking handle
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MAYFIELD 2 Standard Swivel Adaptor - A3018
Disassembly Inspecting for cleanliness Reassembly
1– Remove swivel adaptor (1) from the base
unit (2).
2– Do not attempt to disassamble further.
Pay close attention to:
1– Teeth of the starbursts (3).
2– Area around the locking screw (2).
3– The base of the swivel adaptor for
organic debris.
N/A
(2) locking screw
(1) swivel adaptor
TriStar Swivel Adaptor - A3008
Disassembly Inspecting for cleanliness Reassembly
1– Completely remove swivel adaptor from
any components.
2– Unlock the TriStar bar (1), remove
Locking screw (2) and TriStar bar (1).
(3) teeth
Pay close attention to:
1– Teeth of the starbursts (3).
2– Area around the locking screw (2).
3– The base of the swivel adaptor for
organic debris.
1– Re-install the dual TriStar bar (1).
2– Engage the locking lever (4) on
the TriStar bar (1).
3– Insert and firmly press the torque
screw (2) in place.
(1) TriStar bar
(2) locking screw
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(4) locking lever
(3) teeth
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Step 1: Decontamination after Exposure to highly infectious diseases*
When the MAYFIELD 2 System has been exposed to pathogens that resist normal disinfection methods, the product should
be handled more carefully. The following steps are recommended in accordance with the World Health Organization (WHO)
Protocol for decontamination of highly infectious diseases**:
• 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 base unit & skull clamp to automated cleaning processes until after the decontamination
procedure.
1. Remove gross debris and soil from the device components using soft cloth or paper towels. Minimize formation of
aerosols or droplets during the initial preparation of the product for decontamination.
2. Place parts in a shallow pan and add enough chlorine solution to cover the device completely.
concentration is 20,000 ppm available chlorine. See Bleach Dilution section-Appendix A.
• Allow to soak for 60 minutes.
3. Remove the devices from the bleach solution and rinse components completely with water.
• The devices may then be autoclaved at 134°C for 18 minutes to one hour.
• The devices have been verified through testing to withstand this process up to 15 times without loss of
performance.
Note: Recommended
*Highly infectious diseases including but not limited to transmissible spongiform encephalopathies (TSEs) and Creutzfeldt-Jakob disease (CJD), also known as prion diseases (reference WHO/CDS/CSR/APH/2000.3,
“WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies”, (Switzerland, March 1999) Section 1). ** Integra makes no claims that the following protocol is effective in neutralizing any specific
pathogens. The protocol is a recommendation from the World Health Organization (WHO) based on the best available evidence at the time of publication. As stated in the World Health Organization (WHO) Protocol
for Decontamination of highly infectious diseases. “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.”(Reference WHO/CDS/CSR/APH/2000.3, “WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies”, (Switzerland, March 1999) pp 29).
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Step 2: Cleaning
The instrument can withstand detergents having pH values between 3 and 11. Manufacturer's instructions of the selected
detergent must be followed for this device.
NOTE: The use of highly alkaline agents can tarnish and / or corrode some components. While this does not affect the
performance of the device, we recommend using an acid neutralizing agent immediately aer each use to keep a device
looking new.
2 Cleanings are available:
• Manual Cleaning
• Automatic cleaning
Manual Cleaning
Following these steps is recommended:
1. Remove Base Unit from operating table.
2. Remove Swivel Adaptor from Base Unit.
3. The Base Unit should be thoroughly cleaned after each use. Scrub each component with a soft brush. The Base Unit
can withstand detergents that fall within pH ranges of 3-11. Clean thoroughly to remove any traces of blood and/or
debris and to prevent such blood or debris from interfering with function or movement. Rinse thoroughly with clean
water to remove all traces of detergent.
4. Dry all components with a soft dry towel.
5. After components are totally dry, inspect the unit for cleanliness.
6. Inspect all components to ensure that there is no visible organic debris or residue from cleaning agent. Repeat
process if any visible debris or residue is detected.
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Automatic cleaning (including thermal disinfection)
Note: The washing machine used must comply with the NF EN ISO 15883-1.
1. Disassemble devices (Refer to PREPARATION FOR CLEANING & REASSEMBLY)
2. Rinse components under warm tap water prior to placing in washer.
3. Position the device so as to prevent contact between the elements.
4. Select the cycle for instruments and perform the proper programming for the following cycle:
Phases Time (min) Water Temperature Detergent type and concentration
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Pre-wash 1
Enzyme wash 04:00 Hot tap H2O*
04:00 Cold tap H2O N/A
Multi-tiered enzymatic
detergent with A.P.A
Wash 1
Rinse 1
Thermal rinse**
10:00 60°C Concentrated neutral pH cleaner
00:30 Hot tap H2O* N/A
02:00 82.2°C N/A
Table 1 Instrument Cycle
Step 3: Disinfection
The MAYFIELD 2 Base Unit must be thoroughly cleaned after 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 pathogens, do not apply gluteraldehyde, alcohol or formalin
to the device until the decontamination process is complete. After decontamination, normal cleaning processes can be
employed (see Decontamination section).
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 after the first rinse cycle as indicated in Table 1.
Method 2: Chemical
• Prepare a fresh solution for general disinfection (See below 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.
For General Disinfection
Verify concentration of base hypochlorite is 4.5% or more
Mix 1/2 unit of bleach into 10 units of water
Table 2 Hypochlorite Bleach Mixing Guidelines
* 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
1. Persistent pathogens are resistant to deactivation by normal disinfection procedures and may require more aggressive treatment to achieve disinfection. See guidelines in Decontamination
for recommended procedures.
section
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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).
5. Remove from the washing machine and ensure that all instruments are dried. If necessary, complete drying with a
sterile absorbent, lint-free towel.
6. Check all components to ensure they do not contain organic debris or residue of the cleaning agent. Repeat the
process if a soil is still visible. (For additionally validated cleaning cycles, refer to Appendix B)
Appendix A : Bleach Dilution
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 Preparation Instructions
4.5%
5%
6%
For 4 units bleach into 5 units of water
For 2 units bleach into 3 units of water
For 1 unit bleach into 2 units of water
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 aer each use as this
will help keep your device looking like new.
Appendix B: Additionally Validated Cleaning Cycles
Pre- Wash
Cold water from
building supply
(less than 110°or
43°C)/4min
Temperature
93°C
Hold
Time
1 or more
min.
Wash
Detergent Treatment
Alkaline
(e.g. neodisher®
SeptoClean)
Rinsing
Hot water
from building
supply/2 min
Thermal
Disinfection
Optional
(Drying
Optional)
90°C/2o
min.
50°C/7min
19
90°C
1 or more
min.
Neutral Enzymatic
(e.g. Enzol per
manufacturer's
instructions)
Hot water
from building
supply/ 2 min.
Optional
90°C/2o
min.
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Inspection of Components
A routine inspection of the components of the MAYFIELD 2 Base Unit should be made before each and every procedure to
assist in keeping it in good functional condition and to avoid problems the day of surgery. This check should include the
following:
1. Check to see that all the components of the base unit are available for assembly. Use the Inspection section of this
Instruction Manual for a complete list of components. ALL components must be available and ready for assembly or
the Base Unit should not be used.
2. Check the adjustment of the base locking handles by following these steps.
a. Attach the Base Unit to an OR table and lock in place as shown earlier in this manual.
b. Confirm that the handle is holding as it should.
c. If the handle is not holding under pressure, use the following directions to adjust the handle.
3. Test the operation of the handle after adjustment. Follow the same instructions as outlined earlier in this manual to
verify that the handle is going to hold when force is exerted against it.
4. Check the other components of the Base Unit for function.
a. Check that the Locking Handle assembly will slide easily from one side of the Horizontal Bar to the other.
b. Verify that the Left Bracket is securely fastened and does not move.
c. Fully engage the Locking Knob on the Swivel to make sure that it completely engages the starburst teeth and does
not swivel or move in either direction.
d. With the Locking Lever locked and the Swivel Knob tightened, the total Base Unit should be locked in place and no
movement should be seen.
e. If any movement is observed, re-tighten the knob and adjust the Locking Lever.
5. Perform visual check of all components (Start at on side of the Base Unit and systematically review each component as
you make your way to the other side to assure that you do not miss a component).
a. Check all connections to be free of debris that might impair the function of that component or the one that
connects to that component.
b. Examine all components for cracks on all surfaces.
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Integra Standard Warranty
INTEGRA warrants to the original purchaser only that each new MAYFIELD product is free from manufacturing defects in
material and workmanship under normal use and service for a period of one year (except as otherwise expressly provided as
to accessory items) from the date of delivery by INTEGRA to the first purchaser, but in no event beyond the expiration date
stated on any product labeling.
• Surgical instruments are guaranteed to be free from defects in material and workmanship when maintained
and cleaned properly and used normally for their intended purpose.
• Any covered product that is placed by INTEGRA under a lease, rental or installment purchase agreement and that
requires repair service during the term of such placement agreement shall be repaired in accordance with the terms
of such agreement.
If any covered defect occurs during the warranty period or term of such placement agreement, the purchaser should
communicate directly with INTEGRA’s home office. If purchaser seeks to invoke the terms of this warranty, the product must
be returned to INTEGRA at its home office. The defective product should be returned promptly, properly
packaged and postage prepaid. Loss or damage in return shipment to INTEGRA shall be at CUSTOMER’s risk.
INTEGRA’s sole responsibility under this warranty shall be repair or replacement, at INTEGRA’s sole discretion
at INTEGRA’s expense, subject to the terms of this warranty and applicable agreements.
IN NO EVENT SHALL INTEGRA BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES
IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA PRODUCT. Further, this warranty shall not apply to,
and INTEGRA shall not be responsible for, any loss arising in connection with the purchase or use of any INTEGRA product
that has been repaired by anyone other than an authorized INTEGRA service representative or altered in any way so as, in
INTEGRA’s judgment, to affect its stability or reliability, or which has been subject to misuse, negligence or accident, or
which has been used otherwise than in accordance with the instructions furnished by INTEGRA. THIS LIMITED WARRANTY
IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AND OF ALL OTHER OBLIGATIONS OR
LIABILITIES ON INTEGRA’S PART, AND INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER
PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA’S
PRODUCTS.
INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY AS
WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO PATIENTS. No warranty or guarantee may be created by any act
or statement nor may this Standard Warranty be modified in any way, except as a result of a writing signed by an officer
of INTEGRA. These limitations on the creation or modification of this warranty may not be waived or modified orally
or by any conduct.
Service and Repair
For service and repairs outside the United States, contact your local authorized Integra representative.
Within the United States, send all instruments for service or repair to:
Integra
4900 Charlemar Drive, Building A
Cincinnati, Ohio 45227
(Always include the purchase order number or RMA number and a written description of the problem)
Or phone: 877-444-1114
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EN – ENGLISH
0086
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
n
Always refer to the appropriate instructions for use for complete clinical instructions.
n
Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.
n
Warning: Applicable laws restrict these products to sale by or on the order of a physician.
Additional information for EMEA Customers only:
Produc ts mentione d in this document are CE class I, IIa, IIb or III dev ices. Contac t Integra should you need any additional info rmation on devices clas sification. All the medical device s
mentioned on this document are CE mar ked according to European council directive 93/42/EEC on me dical devices an d its relatives, unles s specific ally identified as “NOT C E MARKED”.
For more information or to place an order, please contact:
United States, Canada, Asia, Pacific, Latin America
USA 800-654-2873
International +1 609-936-5400
integralife.com/contact
Europe, Middle-East, Africa
International +33 (0)4 37 47 59 50
Benelux +32 (0)2 257 4130
France +33 (0)4 37 47 59 10
Switzerland +41 (0)22 721 23 00
United Kingdom +44 (0)1 264 345 781
integralife.eu/contact
U.S. Patents 7,552,492; 8, 683, 630
Integra and the Integra logo are registered trademarks of Integra Life Sciences Corporation in the United States and/or other countr ies. MAYFIELD is a regis tered trademark of SM USA Inc
and is used by Integr a Lifescience s Corporation under license. Neodisher is a trademark of Chemische Fabrik Dr. Weiger t GHBH & Co. KB Enzol is a trademark of Johnson & Johnson.
©2017 Integra LifeSciences Corporation. All rights reser ved. 451A3100 Rev. H 01/17 0649598-1
n 888-980-7742 fax
n +1 609-750-4259 fax
n +33 (0)4 37 47 59 25 fax
n +32 (0)2 253 2466 fax
n +33 (0)4 37 47 59 29 fax
n +41 (0)22 721 23 99 fax
n +44 (0)1 264 363 782 fax
Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Bldg. A
Cincinnati, Ohio 45227
EC REP
Integra LifeSciences Services (France) SAS
Immeuble Séquoia 2
Parc technologique de la Porte des Alpes
69800 Saint Priest
n
USA
n
97 allée Alexandre Borodine
n
FRANCE
22
FR – FRANÇAIS
23
Unité de base MAYFIELD® 2
(A3100, 3101, 3102)
FR – FRANÇAIS
Mode d’emploi
24
FR – FRANÇAIS
2525
0123
Symboles indiqués sur les étiquees
Dangers risquant de produire des dégâts matériels.
Dangers risquant de produire des blessures corporelles ou le décès.
FR – FRANÇAIS
ATTENTION
AVERTISSEMENT
EC REP
REF
Conforme à la directive européenne relative aux dispositifs médicaux (DM).
Mandataire établi dans la Communauté européenne.
Attention, consulter la documentation jointe.
Numéro de référence produit
Fabricant
Attention : Selon la loi fédérale américaine, ce dispositif ne peut être vendu que par un praticien autorisé ou sur son
ordonnance.
Ce dispositif n’est pas indiqué pour être utilisé dans un environnement IRM.
Indications
L’unité de base MAYFIELD® 2 est prévue pour soutenir le patient au cours d’examens de diagnostic et/ou d’interventions
chirurgicales, lorsqu’un support rigide entre la table d'opération et une têtière ou un clameau crânien est nécessaire, et que la
souplesse du positionnement est requise.
AVERTISSEMENT
Tout manquement à lire et à observer les instructions et avertissements donnés dans ce mode d’emploi ainsi que les instructions et
avertissements donnés dans le mode d’emploi du clameau crânien associé, risque d’entraîner le glissement des pointes crâniennes
et des lésions graves chez le patient, notamment des lacérations du cuir chevelu, une fracture du crâne ou même le décès.
Tout manquement à positionner correctement le patient et à serrer et fixer complètement toutes les parties ajustables de ce
dispositif ou des dispositifs similaires risque d’entraîner le glissement des pointes crâniennes et des lésions graves chez le
patient, notamment des lacérations du cuir chevelu, une fracture du crâne ou même le décès.
Le matériel électrochirurgical monopolaire dont la tension de fonctionnement est supérieure à 3 000 V risque de nuire au
patient quand ce système est utilisé avec un clameau crânien.
L’utilisateur doit vérifier que les raccords filetés sont bien serrés et que les dentures radiales sont engagées (si applicable) après
avoir terminé les réglages. Tout manquement à observer cet avertissement risque d’entraîner des lésions graves chez le patient.
ATTENTION
Toujours vérifier que l’unité de base est solidement fixée à la table d’opération. Ne pas utiliser l’unité de base si elle est
endommagée ou ne fonctionne pas correctement.
N’utiliser aucun outil pour la fixation de ce matériel. Un serrage excessif des vis ou molettes de réglage risque d’endommager
l’unité. Si l’unité ne paraît pas solidement fixée après le serrage manuel, ne pas l’utiliser et contacter le représentant
MAYFIELD ou l’équipe de service après-vente MAYFIELD.
La surextension ou la surcharge de l’unité de base risque d’entraîner des déplacements involontaires, d’écourter la durée de
vie du produit et/ou d’endommager l’unité.
Ne pas modifier la construction de ce dispositif sous risque d’entraîner des lésions graves chez le patient.
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FR – FRANÇAIS
Tous les produits MAYFIELD ne peuvent pas nécessairement tous être nettoyés et décontaminés de la même façon que
les produits MAYFIELD 2. Consulter le modes d’emploi individuel (pour chaque dispositif) quant aux procédures correctes
d’entretien et de nettoyage.
Description
L’unité de base MAYFIELD 2 (REF A3101, A3102, A3100) est conçue assurer pour la fixation entre la table d’opération et les
clameaux crâniens MAYFIELD (pour une fixation squelettique rigide) ou les têtières fer à cheval MAYFIELD (pour les interventions
nécessitant uniquement un support et non une fixation rigide). L’unité de base MAYFIELD 2 est conçue pour le positionnement
du patient en décubitus ventral, en décubitus latéral ou en position Park Bench ou assise. L’espacement de la tige de support
peut être facilement réglée pour s’adapter à la plupart des tables d’opération. Aucun outil n’est requis. Consulter la section
« Fixation de l’unité de base à la table d’opération » pour des directives sur le réglage des tiges de support.
Unité de base MAYFIELD 2, Standard A3101
Unité de base MAYFIELD 2, étroite A3100
Unité de base MAYFIELD 2, internationale A3101
Figure 1 Unité de base MAYFIELD 2 – Numéros de référence
Un adaptateur pivotant MAYFIELD 2 standard (A3018) est un composant intégral de l’unité de base. Un adaptateur pivotant
Tri-Star MAYFIELD 2 (A3008) séparé, en option, est disponible en tant qu’accessoire quand des systèmes de chirurgie
assistée par ordinateur (CAO) sont utilisés lors des interventions. L’adaptateur pivotant Tri-Star offre deux dentures radiales
supplémentaires pour la fixation du matériel de CAO auxiliaire.
Chaque unité de base MAYFIELD 2 achetée (A3100, A3101 ou A3102) comprend :
1- Unité de base MAYFIELD 2
1- Adaptateur pivotant MAYFIELD 2 (A3018)
EN OPTION : Adaptateur pivotant Tri-Star MAYFIELD 2 (A3008)
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1. Support de gauche
2. Bouton de verrouillage du support de gauche
3. Tube connecteur
4. Ensemble de poignée de la base
5. Levier de blocage
6. Bras de transition
7. Molette de verrouillage du pivot
8. Adaptateur pivotant (A3018)
9. Bouton de verrouillage de la têtière
10. Support de droite
FR – FRANÇAIS
1. Bras de transition
2. Levier de blocage
3. Loquet
4. Ensemble de poignée de la base
Figure 2A Composants de l’unité de base MAYFIELD 2
Figure 2B Composants de la poignée de la base MAYFIELD 2
28
FR – FRANÇAIS
Figure 3 Adaptateur pivotant Tri-Star MAYFIELD 2 (A3008) EN OPTION
L’unité de base MAYFIELD 2 est conçue pour être utilisée avec le matériel suivant :
Têtière à usage général MAYFIELD A1008
Têtière fer à cheval MAYFIELD A1011*
Têtière fer à cheval adulte MAYFIELD A1012
Adaptateur de barre transversale MAYFIELD A1015**
Adaptateur NeuroGen MAYFIELD A1031 (A et B)
Têtière fer à cheval pédiatrique MAYFIELD A1051*
Clameau crânien MAYFIELD modifié A1059
Support cervical postérieur MAYFIELD A1073
Clameau crânien MAYFIELD Triad A1108
Adaptateur de conversion pour fer à cheval MAYFIELD A1109
Système de support MAYFIELD Infinity A1112
Adaptateur NeuroGen A1113
Clameau crânien MAYFIELD Infinity A1114
Clameau crânien MAYFIELD Infinity A1114A
Clameau crânien 2000 MAYFIELD A2000
Clameau crânien MAYFIELD 2 A3059
*Adaptateur de conversion pour fer à cheval MAYFIELD A1109 requis.
**Raccords pour rail latéral universel A1060 requis.
Remarque : L’utilisation des produits et accessoires MAYFIELD avec le matériel de stabilisation d’autres fabricants n’est pas
recommandée.
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