Integra A2010, A2600R, A2079, A2079E, A20114 Instructions For Use Manual

®
MAYFIELD
Overview and IFU Refresher
Imaging
MAYFIELD is a registered trademark of SM USA Inc. and is used by Integra under license.
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MAYFIELD®Imaging Products

Head Clamp, Base Unit and Accessories
Metal Free Conversion Accessory
Link Arm Extensions
Tri-Star Swivel Adapter
Radiolucent Horseshoe Headrest
Spine Table Adapter (Jackson Table)
Radiolucent Skull Pins
Titanium
Sapphire
Radiolucent Budde®Halo System (this system
is outside the scope of this training)
MAYFIELD is a registered trademark of SM USA Inc. and is used by Integra under license. Budde is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.
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MAYFIELD Imaging: Head Clamp

Clamp:
Made of carbon-filled PEEK
Little or no artifact
Only metal is the spring in the torque knob
Metal-free conversion accessory offers a
completely metal free set-up (different torque knob)
Head Clamp (Standard Configuration)
Metal Free Conversion Accessory
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MAYFIELD Imaging: Head Clamp

Standard Clamp
1. XR2 Standard Torque Screw (439A1095)
2. XR2 Adult Rocker (439A1094)
3. Swivel Lock Knob
4. Skull Clamp Base or Body
5. Plunger
6. Starburst Attachment
7. Skull Clamp Ratchet Extension
Accessories
a. XR2 Force Applicator, 439A1093 (included with
metal free conversion kit, 439A1092)
b. Stop Wheel
1
Head Clamp (Standard Configuration)
Metal Free Conversion Accessory
a
2
7
6
5
b
c
4
3
c. Metal free ratchet extension d. XR2 Child’s Rocker (439A1091)
d
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MAYFIELD Imaging: Base Unit

Base Unit:
Metal free zone around the head clamp
attachment / scanning area
Width adjustable – 2 different sizes
Item No.
A2079 19.5in to 24in
A2079E 22in to 28in
OR Table Width(s) (Side rail to side rail)
(49.6 cm to 61 cm)
(55.9 cm to 71.1 cm)
Base Unit
Metal free zone
Cross Bar Width
Approx. 28”
Approx. 32”
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MAYFIELD Imaging: Base Unit

Identification:
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.Auxiliary Side Rail
11.Side Rail Bracket Locking
Base Unit
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MAYFIELD Imaging: Base Unit Accessories

Tri-Star Swivel Adapter , A21 1 1 Extension Arms
437A2224, 5 inch
437A2225, 7 inch
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MAYFIELD Imaging: Horseshoe Headrests

Pediatric Horseshoe Headrest, A2011
Adult Horseshoe Headrest, A2010
Starburst to attach to standard swivel or tri-star swivel adapter
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MAYFIELD Imaging: Horseshoe Headrests

Spine Table Adapter, A2600R
Metal free zone
Using the Spine Table Adapter with the
Jackson Table
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MAYFIELD Imaging Radiolucent Products (XR2)
Instructions for Use Refresher
10
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MAYFIELD Imaging Base Unit

Review of Components
Rail end bracket
Locking Handle with Locking Lever
Tri-Star Swivel Adaptor (Blue ring) (Available as an Accessory )
Link Arm (Yellow ring)
Std. Swivel Adaptor (Blue ring)
Side Rail
Base Handle Adjustment Knob
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Refresher on Instructions for Use

Step 1. With the rail end brac ket toggle locks loosened a nd t he loc k in g handles unlocked, hold t he
base unit as shown for attachment to t he OR Table; grasp the side rails on the end brackets with each hand.
Second
Locking handles are unlocked & opening “up”
First
Rail end bracket toggle locks are loosened to allow easy attachment to the table side rails
Safety Latch
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Refresher on Instructions for Use

Step 2. Slide the base unit brackets onto the side rails of the operating room table.
Note that locking handles are opening “up” and NOT DOWN
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Refresher on Instructions for Use

Step 3. Secure the brackets to the side rails.
Turning rail end bracket toggle locks
Tighten sec urely to side rails
Cautions:
Keep finger clear of hinge points when closing the base unit locking levers. It is recommended that the levers be closed using the palm of the hand.
Always be sure the locking mechanisms are secure after completing table adjustments. Verify that the locking
lever is secure by confirming that the safety latch is engaged.
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Refresher on Instructions for Use

Step 4. At taching the Link and Adaptor to the Base Unit A ssembly.
Note the color-coded sleeves – Line them up, yellow-to-yellow & blue-to-blue
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Refresher on Instructions for Use

Step 5. Positioned to await attachment of the skull clamp.
Locking handles are unlocked Link and swivel adaptor ar e
connected but not tightene d for easy movement and attachment to the skull clamp
Note: The head section of the OR table can be attached prior to the patient entering the OR.
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Refresher on Instructions for Use

Step 6. With the skull clamp attache d to the pat ient and in position, the Adaptor is brought up for
attachment to the skull clamp
Locking Handle
Swivel/Clamp Torque Knob
Link/Swivel Torque Knob
Attach in this order
1. Attach swivel adaptor to skull clamp
2. Lock both locking handles (Use an “Open-Palm” to close handles. Make certain that the locking levers are engaged)
3. Tighten Swivel Adaptor knob (Blue)
4. Tighten Link attachment (Yellow)
5. Double-check all connections for being tight and secure (double-check does not mean double-tighten)
Link torque knob
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Refresher on Instructions for Use

Step 7. With the system now locked and ready, confirm that all knobs and levers are locked and
secure.
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Refresher on Instructions for Use

Step 8. Knobs should not be overtightened. Over-tightening the mechanisms’ adjustment screws
may result in damage to the unit.
Please remember that overextending or overloading the base unit may result in unintended move m e nt , shortene d product life and/or dama ge to the unit
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Always Remember The Indications for Use, Warnings and Cautions

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Questions?

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Thank you

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