Integra MAYFIELD Infinity XR2 User manual

IMPORTANT
Please Read
MAYFIELD®
Innity XR2 Base Unit
( #A2079)
Instruction Manual
Rx Only
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A, Cincinnati, OH 45227, USA
Tel: [phone] Fax: [phone]
www.Integra-LS.com
Integra NeuroSciences, Limited
Newbury Road, Andover, Hampshire SP10 4 DR, England
Tel: [phone] Fax: [phone]
MAYFIELD®is a registered trademark of SM USA, Inc.
and is used by INTEGRA LIFESCIENCES Corporation under license.

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.
Attention, consult accompaning documents.
Conforms to the European Medical Device Directive (MDD).
Manufacturing site.
European Representative.
Refer to Instruction Manual
Rx Only Caution: Federal (USA) Law restricts this Device to sale by or
on the order of a Licensed practitioner
Product catalog number
REF

Page 1
Inspection
Always inspect instruments before and after 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
Integra LifeSciences, Cincinnati, Ohio or an authorized Integra repair center for evaluation, repair
or replacement.
1. Skull Clamp/Headrest Locking Knob
2. Swivel Adaptor
3. Link Arm Locking Knobs
4. Yoke
5. Crossbar
6. Base Handle
7. Side Rail Bracket
8. Locking Lever
9. Base Handle Adjustment Knob
10. Auxilliary Side Rail
11. Side Rail Bracket Locking Knob
3
4
10
7
3
1
5
11
9
6
8
2
Figure 1 A2079 Innity XR2 Base Unit Components

Page 2
Indication For Use
The Innity XR2 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 and where X-ray imaging
modalities will be used.
WARNING!
Failure to read and follow the instructions furnished in this product insert may
result in serious patient injury.
Do not steam sterilize; components may be damaged by high heat leading to
device damage and reduced performance.
The headrest or skull clamp must be securely fastened to the base unit. Failure
to fully tighten all adjustment portions of this or any similar device may result
in serious patient injury.
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.
Over-tightening the mechanisms adjustment screws may result in damage to
the unit.
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.

Page 3
Description
The MAYFIELD Innity XR2 Base Unit is designed to provide attachment from the operating room
table to MAYFIELD Skull Clamps for rigid skeletal xation or MAYFIELD Horseshoe Headrests for
procedures where support only is required and not rigid xation. The XR2 Base Unit is designed
for patient positioning in the prone, lateral or supine positions for attachment to either a skull
clamp or a horseshoe headrest. It attaches to the OR table side rails with easy adjustment for
tables of a variety of widths.
The Innity XR2 Base Unit is suitable for Digital Subtraction Angiography (DSA), Fluoroscopy and
CT imaging modalities.
The components of the XR2 Base Unit are color-coded for easy assembly for use and disassembly
for cleaning and storage. A separate storage case is provided with the base unit for safe-keeping
between procedures and for use to ship the product in for repair or maintenance.
A separate, optional Tri-Star Swivel Adaptor (A2111) is available for use with the XR2 Base Unit
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. See the
separate Instruction Manual for the A2111 for information.
The Innity XR2 Base Unit is designed for use with the following equipment:
A2114 MAYFIELD Innity XR2 Skull Clamp
A2002 MAYFIELD 2000 Radiolucent Skull Clamp
A2111 MAYFIELD Innity XR2 Tri-Star Swivel Adaptor
A1058 MAYFIELD Radiolucent Skull Clamp
A2010 MAYFIELD Radiolucent Horseshoe Headrest
A2011 MAYFIELD Pediatric Radiolucent Horseshoe Headrest
NOTE: Use of MAYFIELD products and accessories in conjunction with other
manufacturer’s stabilization equipment is not recommended.

Page 4
The MAYFIELD Innity XR2 Base Unit (A2079) includes:
(1) MAYFIELD XR2 Base Unit
(2) MAYFIELD XR2 Link Arm Assembly 437A2222
(3) MAYFIELD XR2 Swivel Adaptor 437A2400
Set-up Instructions:
3
1. Yoke (Yellow tip to Link Arm Locking Knob with Yellow Sleeve
2. Link Arm Assembly
3. Swivel Adaptor (Blue tip to Link Arm Knob with Blue Sleeve)
2
1
Figure 2 Base Unit Set-up

Page 5
Attachment to Operating Room Table
1. Open Base Unit Locking Levers.
2. Loosen knobs on link arm assembly.
3. Grasp auxiliary side rails on the side rail brackets and carefully place unit on the table’s side
rails.
4. Align Base Unit with the operating table side rails and slide on.
5. Ensure operating table side rails protrude fully through the Base Unit auxiliary rails and
lock into place by tightening the side rail bracket locking knobs.
NOTE: For best alignment results, ensure the operating table side rails protrude evenly on
both sides of the Side Rail Brackets.
Open Locking Levers
Loosen
Link Arm
Knobs
Tighten Side
Rail Locking
Knobs
Operating
Table
Side Rail
Side
Rail
Brackets
Side Rail
Bracket
Figure 3 Mounting Base Unit to Operating Table

Page 6
CAUTION: Keep ngers clear of hinge points when closing the Base Unit
Locking Levers. See Figure 4 below. It is recommended that the levers be closed using
the palm of the hand.
Figure 4 Locking Mechanism
CAUTION: Always be sure the Locking mechanisms are secure after
completing table adjustments. Verify that the Locking Lever is secure by
conrming that the Latch is engaged.

Page 7
Attachment 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 be brought up for attachment.
1. The base unit should be brought up 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.
2. Securely fasten the skull clamp to the MAYFIELD base unit by attachment to the Swivel
Adaptor. Close Locking Levers. Turn clockwise all of the Locking Knobs of the other
components of the base unit making certain all starburst teeth are fully meshed (where
applicable) on all joints of the base unit after adjustments are complete.
CAUTION!
Before fully tightening, always be certain that the starburst teeth of the Swivel
Adaptor and other starburst ttings are the same size and properly mesh.
Failure to do so may damage ttings. Figure 5 shows a typical starburst
connection and proper meshing of teeth.
Skull Clamp/Headrest
locking knob
of the Swivel
Adaptor
Figure 5 Attachment of Skull Clamp

Page 8
Attachment of Accessories (A2111 Tri-Star Swivel Adaptor)
1. Position base unit Swivel Adaptor to desired position.
2. Insert the XR2 TriStar Swivel Adaptor retaining screw into the Link Arm Locking Knob and
rotate knob clockwise.
3. When the XR2 TriStar Swivel Adaptor is set to the desired position, engage starburst teeth
and turn the Link Arm Locking Knob clockwise to secure.
NOTE: Refer to the Tri-Star Swivel Adaptor Instruction For Use manual for proper use and
care.
Link
Arm
Locking
Knob
Link
Arm
XR2 TriStar
Swivel
Adaptor
Starburst Teeth
Figure 6 Mounting XR2 Tri-Star Swivel Adaptor

Page 9
Cleaning of the MAYFIELD Innity XR2 Base Unit
WARNING!
Do Not Steam Sterilize! The carbon Fiber material and plastic components
may be damaged by heat.
Following these steps is recommended:
1. Remove base unit from operating table support rails.
2. Remove Swivel Adaptor, and Link Arm Assembly from base unit
3. The Innity XR2 Base Unit should be thoroughly cleaned after each use. Scrub each
component with a soft brush and use only a pH-neutral detergent. 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.
4. Dry all components with a soft dry towel.
5. After components are totally dry, re-assemble the components. Unit is ready for next use.
Optional Automatic Wash Cycle:
CAUTION!
Any deviation from this guideline could result in damage to equipment as well
as improper cleaning results. Parameters given below must be followed exactly
in order to assure proper cleaning and avoid damage to the equipment.
• Disassemble the device as indicated in section Cleaning of the MAYFIELD Innity XR2
Base Unit.
• 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.

Page 10
Table 1 Instrument Cycle
Phase Time in minutes
Water
Temperature
Detergent type &
Concentration
Pre-Wash 1
Enzyme Wash
Wash 1
Rinse 1
Thermal Rinse**
04:00
04:00
10:00
00:30
02:00
Cold tap H2O
Hot tap H2O*
60° C
Hot tap H2O*
82.2° C
N/A
Endozime® AW
Triple plus w/
A.P.A., 1:128 ratio
Renu-Klenz®,
1:256 ratio
N/A
N/A
* Hot Tap water not to exceed 82.2C
** Optional phase for disinfection of components
Table 1 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 debris or residue is detected.
Disinfection
Further disinfection of device components may be achieved using one of the following methods.
Method 1: Chemical
• With device cleaned and still disassembled, wipe all surfaces with sterile gauze moistened
with 70% Isopropyl Alcohol (IPA). Be sure to achieve even coverage on all surfaces.
• Assure the device stays wet with the 70% IPA for a minimum of 10 minutes.
• Dry the device with a sterile lint free cloth or blow dry with ltered pressurized air.
Method 2: Thermal Rinse
• A Thermal Disinfection phase maybe added after the rinse cycle as indicated in table 1.

Page 11
Maintenance and Care:
The Innity XR2 Base Unit should be returned to its storage case after each use.
NOTE: Ensure all components have completely dried after cleaning before returning to case.
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 LifeSciences
for inspection.
Inspection of Components
A routine inspection of the components of the MAYFIELD Innity XR2 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 to the side rails.
b. Raise the Crossbar to be even with the top of the OR table, locking the handles.
c. With your hands on either ends of the Crossbar, push down on the Crossbar attempting
to move it. If with minimal force, the Crossbar moves, adjustment to increase the
locking power of the Locking Handles should be made as outlined in this manual.
d. If the handles are too hard to close, adjustment to decrease the locking power of the
Locking Handles should be made as outlined in this manual.
3. With the Locking Handles unlocked and all the components attached but loose, raise and
lower the base unit, rotating all joints. All should freely rotate without any“ratcheting”
noise (starburst teeth hitting together as rotated). If this ratcheting noise is heard, loosen
the joint that is causing the noise.
4. Check the other components for function
a. Again, with the base unit Crossbar raised to be level with the top of the OR table, lock
the locking handles.
b. Lock the link arm locking knobs
c. Verify that all starbursts are fully engaged and locked
d. With these knobs locked, the total base unit should be locked into place and no
movement should be seen.

Page 12
e. Exert force to each component to detect any movement. There should be no lateral or
rotational movement with the knobs of the Link Arm totally tightened. If movement is
seen, re-tighten the knobs and check again.
5. Perform visual check of all components (Start at one 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.
c. Check the side rails to be securely fastened to the Side Rail Brackets
d. Check that the Shock Cushion is present and in proper position on both Locking Handle
assemblies.
e. Slide the yoke from side to side on the crossbar to make certain that the surface is
smooth and free of debris or anything that would impede its movement.
Base Locking Lever Handle Adjustment Procedure
Periodically it is necessary to adjust the tension in the Base Handle Assemblies to compensate for
changes due to normal use.
1. Open Locking Lever. For safety, the tension Adjustment Knob is not adjustable while the
Locking Lever is closed.
Locking Lever
Locking
Lever
Opened
Auxiliary Side Rail
Tension
Adjustment Knob
Figure 7 Opening Locking Lever

Page 13
2. Grasp the Adjustment Knob and pull it away from the Locking Bracket to unlock.
3. Holding the Adjustment Knob in its unlocked position, rotate it in the desired direction to
adjust tension. Clockwise (+ plus) direction to increase tension, or Counterclockwise
(- minus) direction to decrease tension.
Adjustment Knob
Adjustment Knob Pulled to
the Unlocked Position
Increase Locking
Lever Tension
Decrease Locking
Lever Tension
Figure 8 Adjustment Knob

Page 14
4. Return the Adjustment Knob to its locked position by releasing it and rotating it to the
nearest seated locking position.
Adjustment Knob
Adjustment Knob Retracted
to the Locked Position
Figure 9 Adjustment Knob in Locked Position
5. Test the operation of the handle. With the Locking Lever fully opened, the Locking Bracket
should rotate freely. With the Locking Lever closed, the Locking Bracket should not rotate.
NOTE: Once the desired setting is achieved conrm the Adjustment Knob is in the locked,
seated position.
CAUTION!
It is possible to adjust the handle to the point that the Locking Lever requires
excessive force to close. Do not exert excessive force as this may result in
damage to the device if the lever is forced closed.

Page 15
Integra Standard Warranty
INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) warrants to the original purchaser only that
each new INTEGRA Mayeld® 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 rst
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 oce. If purchaser seeks to
invoke the terms of this warranty, the product must be returned to INTEGRA at its home oce.
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 aect 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
modied in any way, except as a result of a writing signed by an ocer of INTEGRA. These
limitations on the creation or modication of this warranty may not be waived or modied orally
or by any conduct.

Page 16
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 LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, Ohio 45227
(Always include the purchase order number and a written description of the problem)
Or phone: [phone]
Publication Number 451A2079 Rev A

IMPORTANTE
Por favor, léase
MAYFIELD®
Innity XR2 Base
( #A2079)
Manual de instrucciones
Sólo bajo prescripción médica
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A, Cincinnati, OH 45227, EE. UU.
Tel.: [phone] Fax: [phone]
www.Integra-LS.com
Integra NeuroSciences, Limited
Newbury Road, Andover, Hampshire SP10 4 DR, Inglaterra
Tel.: [phone] Fax: [phone]
MAYFIELD®es una marca registrada de SM USA, Inc.
y es utilizado por INTEGRA LIFESCIENCES Corporation bajo licencia.

Signicado de los símbolos utilizados en este manual - ESPAÑOL
PRECAUCIÓN!
Peligros que podrían causar daños materiales o al equipo.
Peligros que podrían ocasionar lesiones personales graves o la muerte.
Atención, consulte los documentos adjuntos.
Conforme con la Directiva Europea sobre Dispositivos Médicos (MDD).
Lugar de fabricación.
Representante europeo.
Consulte el Manual de instrucciones.
Sólo bajo prescripción médica
Precaución: La ley federal (EE. UU.) restringe la venta de este dispositivo a médicos
colegiados o por prescripción facultativa.
Número de catálogo del product
REF