MAYFIELD Imaging Overview and IFU Refresher Guide

MAYFIELD® Imaging Products

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Head Clamp, Base Unit and Accessories • • •

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Radiolucent Horseshoe Headrest Spine Table Adapter (Jackson Table) Radiolucent Skull Pins • •

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Metal Free Conversion Accessory Link Arm Extensions Tri-Star Swivel Adapter

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

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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 2

1

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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

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3

Accessories a. XR2 Force Applicator, 439A1093 (included with metal free conversion kit, 439A1092) b. Stop Wheel c. Metal free ratchet extension d. XR2 Child’s Rocker (439A1091)

Head Clamp (Standard Configuration)

Metal Free Conversion Accessory a

7

6

5

4

b c

d

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MAYFIELD Imaging: Base Unit

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Base Unit

Base Unit: • •

Metal free zone around the head clamp attachment / scanning area Width adjustable – 2 different sizes

Item No.

OR Table Width(s) (Side rail to side rail)

Cross Bar Width

A2079

19.5in to 24in (49.6 cm to 61 cm)

Approx. 28”

A2079E

22in to 28in (55.9 cm to 71.1 cm)

Approx. 32”

Metal free zone

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MAYFIELD Imaging: Base Unit

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Identification:

Base Unit

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

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MAYFIELD Imaging: Base Unit Accessories

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Tri-Star Swivel Adapter, A2111

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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

Using the Spine Table Adapter with the Jackson Table

Metal free zone

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MAYFIELD Imaging Radiolucent Products (XR2) Instructions for Use Refresher

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MAYFIELD Imaging Base Unit Review of Components

Rail end bracket

Std. Swivel Adaptor (Blue ring) Side Rail

Locking Handle with Locking Lever

Link Arm (Yellow ring)

Base Handle Adjustment Knob

Tri-Star Swivel Adaptor (Blue ring) (Available as an Accessory)

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Refresher on Instructions for Use Step 1. With the rail end bracket toggle locks loosened and the locking handles unlocked, hold the base unit as shown for attachment to the 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 securely 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. Attaching the Link and Adaptor to the Base Unit Assembly.

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 are connected but not tightened 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 attached to the patient and in position, the Adaptor is brought up for attachment to the skull clamp

Attach in this order 1. Attach swivel adaptor to skull clamp

Locking Handle

2. Lock both locking handles (Use an “Open-Palm” to close handles. Make certain that the locking levers are engaged)

Swivel/Clamp Torque Knob

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/Swivel 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 movement, shortened product life and/or damage to the unit

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Always Remember The Indications for Use, Warnings and Cautions

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