MAYFIELD Infinity XR2 Skull Clamp Instructions Manual Rev HA Jan 2021

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MAYFIELD® Infinity XR2 Skull Clamp (A2114) Instruction Manual

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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

Caution

Product complies with the requirements of MDR 2017/745

Manufacturer

Authorized Representative in the European Community

Consult Instructions for Use

Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare practitioner

MR conditional

Catalog number

Medical Device

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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 an authorized Integra repair center for evaluation, repair or replacement.

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1. XR2 Standard Torque Screw (439A1095) 2. Skull Clamp Base or Body 3. Plunger 4. Skull Clamp Ratchet Extension 5. Starburst A achment 6. XR2 Adult Rocker (439A1094) 7. XR2 Child’s Rocker (439A1091) 8. XR2 Force Applicator (439A1093) 9. Swivel Lock Knob 10. Stop Wheel

7 Optional XR2 Metal-Free Conversion Accessory (439A1092)

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9 Standard Extension Arm

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5 2

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Figure 1 40A2114 Infinity XR2 Skull Clamp

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The MAYFIELD® Infinity XR2 Skull Clamp is designed for use with the following equipment: A2079 MAYFIELD Infinity XR2 Base Unit A1079 MAYFIELD Radiolucent Base Unit A2003 MAYFIELD Radiolucent Skull Clamp and Adaptor System A2111 MAYFIELD Infinity XR2 Tri-Star Swivel Adaptor A1111 MAYFIELD Tri-Star Swivel Adaptor ALL Styles of MAYFIELD Skull Pins (A1047, A1048, A1072, A1083, A1084, A2020, A1119, A1120, A1121, A1122) NOTE: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s stabilization equipment is not recommended.

Table 1 Skull Clamp Position Diagram

Correct

Figure A

SKULL CLAMP CL HEAD

Incorrect

Figure B

CL F

F

Correct

HEAD CL SKULL CLAMP

F

F = APPLIED FORCE

Figure C

Table 1 Skull Clamp Position Diagram NOTE: Patient positioning and application of the skull clamp can be made with numerous variations. The patient’s final position should be acceptable to the surgeon, taking into account the patient’s anatomy, pressure points, neck flexibility and access to the surgical target. In the chart above, the ovals representing the patient’s head have centerlines drawn on them. The diagrams show examples of proper and improper applications of the skull clamp. The direction of the single-pin should point directly through the center point created by the centerlines of the patient’s head with the pins on the two-pin side of the skull clamp being equidistant to the single-pin line of direction to obtain the highest degree of stability.

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Indication For Use / Intended Purpose The MAYFIELD Infinity XR2 Skull Clamp is placed on the patient’s skull to hold their head and neck securely in a particular position when rigid fixation is desired. The Skull Clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm X-Ray, digital subtraction techniques, and MR imaging.

WARNING! Failure to read and follow instructions furnished in this product insert may result in skull pin slippage and serious patient injury, such as scalp lacerations, skull fracture, or even death. The Skull Clamp must be applied along the center line of the patient’s head with pins entering the skull perpendicularly (See Table 1). Failure to properly position the Skull Clamp on the patient’s head could result in patient injury such as scalp laceration due to skull pin slippage. Failure to properly position patient and to fully secure all adjustment positions of the Skull Clamp or any support device may result in patient injury. It is cautioned that only MAYFIELD products have been validatd for use with other MAYFIELD products. Integra cannot advise whether other suppliers’ products would function properly with the MAYFIELD line of products. Integra does not offer warrantly protection when a non-MAYFIELD brand product is used with a MAYFIELD branded product Do not alter the design of the device in part or whole as serious patient injury could result.

Intended Population MAYFIELD Skull Clamp fixation devices are not recommended for use on children under five (5) years of age. Extreme caution should be exercised in pediatric cases because of the thin skull.

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MR Information: Non clinical testing demonstrated that the MAYFIELD Infinity XR2 Skull Clamp is “MR CONDITIONAL”. Established under the following conditions: Static Magnetic Field Strength Spatial Gradient Magnetic Field Static Magnetic Field Strength Spatial Gradient Magnetic Field

1.5 Tesla 332 Gauss/cm 3.0 Tesla 517 Gauss/cm

The MAYFIELD Infinity XR2 Skull Clamp is only to be used with MAYFIELD Skull Pins. The MAYFIELD Skull Pin MR status chart for use with the MAYFIELD Infinity XR2 is below: MAYFIELD Skull Pins Sapphire Skull pins

MR Status when used with MAYFIELD Infinity XR2 MR CONDITIONAL

A-2020 Titanium Skull Pins

≤3T MR CONDITIONAL

A1119, A1120, A1121, A1122 Steel Skull Pins

≤3T MR UNSAFE

A1047, A1048, A1072, A1083, A1084

MRI Safety Information

Non-clinical testing has demonstrated that the MAYFIELD Infinity XR2 Skull Clamp is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions: • S tatic magnetic field of 3T or less • O  nly MR Conditional MAYFIELD Skull pins should be used In non-clinical testing, the MAYFIELD Infinity XR2 Skull Clamp did not produce an image artifact.

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Description The MAYFIELD Infinity XR2 Skull Clamp is designed to be a multifunctional, cranial stabilization/ fixation device. Its basic configuration delivers standard MAYFIELD Skull Clamp performance, that is, provide rigid skeletal fixation in conjunction with the Infinity XR2 Base Unit (A2079) or the MAYFIELD Radiolucent Base Unit (A1079) or with any of the other products that are listed in the preceding pages of this manual. The Infinity XR2 Skull Clamp is suitable for Digital Subtraction Angiography (DSA), Fluoroscopy, CT imaging, and MR imaging modalities. With the use of the optional Force Applicator (Removable, 439A1093), the user can temporarily detach this component of the clamp prior to scanning; thereby removing a potential source of imaging artifact. The flexibility of components allows the surgeon to tailor the skull clamp and the cranial stabilization equipment to the requirements of their patient’s surgical procedure and the use of image-guided surgery systems. The Infinity XR2 Skull Clamp is designed to allow the surgeon freedom in positioning the skull pins for fixation. Avoidance of critical areas of the skull is facilitated by a two-pin rocker arm that swivels 360 degrees. To simplify patient repositioning after pin impingement, the rocker arm can be rotated without adjustment of the Torque Screw force on the single-pin side of the clamp.

The MAYFIELD Infinity XR2 Skull Clamp (40A2114) includes: Adult Rocker Arm (439A1094) Standard Torque Screw (439A1095) Standard Ratchet Extension Arm Optional Accessories: Child’s Rocker Accessory (439A1091) Force Applicator (Removable, 439A1093) Metal-Free Conversion Accessory (439A1092)

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Equipment Selection The Infinity XR2 Skull Clamp provides the surgeon with the ability to select the most suitable components to match up with their practice. The standard Infinity XR2 is supplied with the Adult Rocker Arm. An optional Child’s Rocker Accessory (439A1091) is available. The rocker arms can be easily removed for exchange or cleaning by pulling the rocker arm straight out of the swivel head of the skull clamp. See Figure 2 below.

CAUTION! Visually confirm that there are no skull pins in the rocker arm or torque screw before removing the rocker attachment. It is safest to completely remove the ratchet extension from the clamp before removing skull pins or changing rocker attachments.

Optional Child’s Rocker Arm

Standard Adult Rocker Arm

Figure 2 Rocker Arm Attachment

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Be sure that the rocker attachment is properly seated, and there is minimal gap between the rocker attachment base and the swivel head.

Figure 2a

Adult Rocker Arm (Standard) This is the preferred attachment for use on patients with adult head sizes.

Figure 3 Adult Rocker Arm (Standard)

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Child’s Rocker Arm (Optional) This rocker arm provides pin spacing more suitable for patients with smaller head sizes.

Figure 4 Child’s Rocker Arm (Optional)

Torque Screw (Standard) This torque screw can develop up to 80 lbs. (356 N) of force; graduated in 20 lb. (89 N) increments.

Figure 5 Standard Torque Screw (439A1095)

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Mounting of MAYFIELD Skull Pins NOTE: Use only MAYFIELD brand Skull Pins with this Skull Clamp. Refer to Skull Pin Instructions For Use for further information.

Seat pins so there is no gap between the shoulder of the pin and the face of the socket

Adult Rocker

Childs Rocker Arm

Figure 6 Mounting Skull Pins

CAUTION! Carefully inspect reusable skull pins before each use. To maintain proper fixation, pins should be of equal length. Damaged (dull, bent, etc.) pins should be replaced. It is recommended that spare pins always be kept available.

WARNING! Never attempt to resharpen skull pins. Dull or bent pins should be replaced. NOTE: When using MAYFIELD Skull Pins, follow Instructions For Use supplied with the product.

WARNING! Skull pins are not recommended for use on children under five (5) years of age and extreme caution should be exercised in pediatric cases because of the thin skull. MAYFIELD Child Skull Pins are recommended for young children over the age of five (5) years. It is at the discretion of the user, when the adult or child skull pins should be used.

CAUTION! Only MAYFIELD branded skull pins be used with MAYFIELD Skull Clamps. Integra does not offer warranty protection when a Non-MAYFIELD brand skull pin is used with a MAYFIELD Skull Clamp.

CAUTION! CAUTION: 60 lbs. (267 N) of force is recommended for adults. 40 lbs (178 N) of force is recommended for children. All force settings are at the user’s discretion. Never exceed 80 lbs. (356 N) of force. 13

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Skull Clamp Patient Fixation WARNING! 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. 1. Unlock the Swivel Lock Knob so the rocker arm can rotate freely 360 degrees. The Swivel Lock Knob is unlocked by rotating the knob to align the arrow with the open lock symbol; see Figure 7.

Swivel Lock Knob

Figure 7 Unlocking Swivel Lock Knob 2. Rotate the rocker arm into the desired position for placement of the skull pins; normally perpendicular to the floor for prone or supine positions or parallel to the floor for patients in the sitting position. NOTE: The Torque Screw force gauge provides the surgeon with a visual display of the clamping force value. Each scribed line indicates a 20lbs. (89N) increment of force. See Table 2 Torque Screw Line Indicator/Clamping Force. This will also align the rocker arm parallel with the direction of the surgical force (See Table 1 Skull Clamp Position Diagram).

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3. Pull and hold the plunger out to slide the two halves of the clamp apart to allow placement around the patient’s head. 4. Position the 2-pin rocker arm so the skull pins are equidistant from a center line of the head. (see Figure 8). 5. Seat the skull pins securely into the cranial table. Skull pins should enter the scalp at a 90 degree angle, perpendicular to the surface of the head.

Correct

Incorrect

Figure 8 Positioning Rocker Arm Skull Pins

CAUTION! Make sure the trajectory of the single-pin in the Skull Clamp intersects the center of the patient’s head and the rocker arm to correctly secure the Skull Clamp to the patient’s head.

CAUTION! Avoid the areas of the frontal sinus, temporal fossa, major blood vessels, nerves, previously restored or abnormally thin bone.

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6. Increase Skull Clamp force by advancing the Torque Screw to a desired setting, indicated on the visual readout, then back off one quarter turn. NOTE: The Torque Screw provides the surgeon with a visual display of the clamping force applied. Each scribed line indicates a 20 lbs. (89 N) increment of force. Refer to Table 2 below:

Clamping Force

Torque Screw Line Indicator 1 2 3 4

= = = =

20 lbs. (89 N) 40 lbs. (178 N) 60 lbs. (267 N) 80 lbs. (356 N)

Table 2 Torque Screw Line Indicator/Clamping Force NOTE: To achieve independent fixation for adults, it is recommended that a minimum of 60 lbs. (267 N) of force be applied by the Skull Clamp. An additional force range reaching 80 lbs. (356 N) is available if desired.

WARNING! Never exceed 80 lbs. (356 N) of force.

Figure 9 Standard Torque Screw (439A1095)

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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 to be brought up for attachment. 1. The Base Unit (A1079, A2079), with all components, should be attached to the operating room table with the side rail clamps securely tightened. All linkage components (Yoke, Transitional Members, Links, Swivel Adaptors) should be attached but not fully tightened. The starburst teeth should not be engaged. All components should move freely for easy positioning for attachment to the Skull Clamp. 2. The attached but loose components of 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. 3. Securely fasten the Skull Clamp to the MAYFIELD Base Unit by attachment to the Swivel Adaptor. Turn clockwise all of the Locking Knobs of the other components of the Base Unit making certain all starburst teeth are 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 the Transitional Member fittings are the same size and properly mesh. Failure to do so may damage fittings. Figure 10 shows a typical starburst connection and proper meshing of teeth.

Skull Clamp/Headrest Locking Knob of the Swivel Adaptor

Figure 10 Mounting Skull Clamp

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XR2 Metal-Free Conversion Accessory (Optional) This accessory provides the surgeon the opportunity to remove a potential source of imaging artifact associated with the torque screw that has metal parts to supply the controlled-force to the skull pins. This accessory includes a special Ratchet Extension that allows for the use of the optional Force Applicator (439A1093).

Figure 11 Metal-Free Conversion Accessory (439A1092)

Removable Torque Screw (Optional) This removable Force Applicator can develop up to 80 lbs. (356 N) of force; graduated in 20 lbs. (89 N) increments. The removable Force Applicator is as shown below in Figure 12. This Force Applicator can be detached after the force is applied and before scanning; thereby removing a potential source of imaging artifact. NOTE: This removable Force Applicator requires a specially designed ratchet extension that is part of the optional XR2 Metal-Free Conversion Accessory.

Figure 12 Force Applicator (Removable 439A1093)

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Metal-Free Conversion Accessory Procedures Starting Position: 1. Rotate the Stop Wheel to position it close to the single-pin socket.

Single Pin Socket

Figure 13 Stop Wheel Rotation

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2. Install the Force Applicator and advance it until a gap on the carrier shaft becomes visible between the Stop Wheel and the face of the ratchet.

Figure 14 Installation of Force Applicator

WARNING! This check is important. It facilitates clamp application and removal. This starting position is necessary to allow removal of the clamp from the patient following the procedure. 3. Press the Stop Wheel toward the Force Applicator until it registers as illustrated in Figure 15.

Figure 15 Clamp Application and Removal Check

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4. Verify that the swivel is free to rotate by moving the Swivel Lock Knob to the Unlock position. Move the Rocker Arm to position it as desired.

Figure 16 Swivel Rotation Verification 5. Draw Plunger down far enough to allow the clamp to be opened to an appropriate width. Install skull pins. (Use Radiolucent Pins (A2020) if the clamp will be applied to the patient during the scan).

Figure 17 Opening Clamp 21