Integra MAYFIELD Infinity XR2 Manuale utente
IMPORTANT
Please Read
MAYFIELD®
Innity XR2 Base Unit
( #A2079)
Instruction Manual
Rx Only
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A, Cincinnati, OH 45227, USA
Tel: 1-513-533-7979 Fax: 1-513-271-1915
www.Integra-LS.com
Integra NeuroSciences, Limited
Newbury Road, Andover, Hampshire SP10 4 DR, England
Tel: +44 (0) 1264 345 700 Fax: +44 (0) 1264 332 113
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 Innity XR2 Base Unit Components
Page 2
Indication For Use
The Innity 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 Innity 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 Innity 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 Innity XR2 Base Unit is designed for use with the following equipment:
A2114 MAYFIELD Innity XR2 Skull Clamp
A2002 MAYFIELD 2000 Radiolucent Skull Clamp
A2111 MAYFIELD Innity 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 Innity 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
conrming 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
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