MAYFIELD Infinity XR2 Base Units Instructions Manual Rev CA Jan 2021

EN – English

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, consult accompaning documents

Product complies with the requirements of MDR 2017/745

Manufacturing site

European Representative

Caution: Federal (USA) Law restricts this Device to sale by or on the order of a Licensed practitioner

Product catalog number

This device is not indicated for use in MR environment

No tools

Medical Device 2

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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 Integra LifeSciences, Cincinnati, Ohio or an authorized Integra repair center for evaluation, repair or replacement.

XR2 Radiolucent Base Unit, Standard 2079

XR2 Radiolucent Base Unit, Extended 2079E

Item No. A2079 A2079E

OR Table Width(s) (Side rail to side rail) 19.5in to 24in (49.6 cm to 61 cm) 22in to 28in (55.9 cm to 71.1 cm)

Figure 1 Infinity XR2 Base Unit Catalog Numbers 3

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1

10 2

8

3

11

9

7

6

5 3 4

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 Knob Figure 1A A2079 Infinity XR2 Base Unit Components

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Indication For Use/Intended Purpose The Infinity 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 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. 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 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. 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.

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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Description The MAYFIELD® Infinity XR2 Base Unit is designed to provide attachment from the operating room table to MAYFIELD Skull Clamps for rigid skeletal fixation or MAYFIELD Horseshoe Headrests for procedures where support only is required and not rigid fixation. 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 Infinity 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 Infinity XR2 Base Unit is designed for use with the following equipment: A2114 MAYFIELD Infinity XR2 Skull Clamp A2002 MAYFIELD 2000 Radiolucent Skull Clamp A2111 MAYFIELD Infinity XR2 Tri-Star Swivel Adaptor A1058 MAYFIELD Radiolucent Skull Clamp A2010 MAYFIELD Radiolucent Horseshoe Headrest A2011 MAYFIELD Pediatric Radiolucent Horseshoe Headrest 437A2224 5 inch XR2 Extension Arm Assembly (12.7 cm) 437A2225 7 inch XR2 Extension Arm Assembly (17.8 cm) NOTE: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s stabilization equipment is not recommended. The MAYFIELD Infinity XR2 Base Unit (A2079) includes: (1) MAYFIELD XR2 Base Unit (2) MAYFIELD XR2 Link Arm Assembly 437A2222 (3) MAYFIELD XR2 Swivel Adaptor 437A2400

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Set-up Instructions:

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1

2

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)

Figure 2 Base Unit Set-up

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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.

Side Rail Brackets

Open Locking Levers

Loosen Link Arm Knobs

Side Rail Bracket Operating Table Side Rail Tighten Side Rail Locking Knobs

Figure 3 Mounting Base Unit to Operating Table 8

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CAUTION: Keep fingers 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 confirming that the Latch is engaged.

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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 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 fittings are the same size and properly mesh. Failure to do so may damage fittings. 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

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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.

XR2 TriStar Swivel Adaptor

Starburst Teeth Link Arm Locking Knob Link Arm

Figure 6 Mounting XR2 Tri-Star Swivel Adaptor

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Optional Products

7 inch Extension Arm (437A2225)

5 inch Extension Arm (437A2224)

Figure 7 XR2 Extension Arm Assemblies (5 Inch (437A2224), 7 Inch (437A2225))

The MAYFIELD XR2 Extension Arm Assemblies can provide an additional 5 inches (12.7 cm) or 7 inches (17.8 cm) of reach to the components of the XR2 Base Units (A2079, A2079E). Using one of the extensions will allow the non-radiolucent components of the XR2 base unit to be positioned away from metal-sensitive imaging systems. Interfacing with some of the new intra-operative imaging systems can be easier with these new Extension Arm Assemblies. Note: By design, only one of the Extension Arm Assemblies can be used at a time.

7 Inch Extension Arm (437A2225)

Figure 8 XR2 Base Unit shown with the 7 Inch Extension Arm (437A2225)

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Cleaning of the MAYFIELD Infinity XR2 Base Unit Follow the cleaning instructions outlined in the Cleaning of the MAYFIELD Infinity 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 Infinity 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.

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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 Infinity 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.

Table 1 Instrument Cycle Phase

Time in minutes

Water Temperature

Detergent type & Concentration

Pre-Wash 1

04:00

Cold tap H2O

N/A

Enzyme Wash

04:00

Hot tap H2O*

Endozime® AW Triple plus w/ A.P.A., 1:128 ratio

Wash 1

10:00

60° C

Renu-Klenz™, 1:256 ratio

Rinse 1

00:30

Hot tap H2O*

N/A

Thermal Rinse**

02:00

82.2° C

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.

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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 filtered pressurized air.

Method 2: Thermal Rinse •

A Thermal Disinfection phase maybe added after the rinse cycle as indicated in table 1.

Maintenance and Care: The Infinity 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. The life expectancy of the MAYFIELD products is expected to be as long as 7 years. To ensure proper function and to extend the life and performance of the equipment, Integra LifeSciences recommends the following: Recommended Action Return the device to the Integra LifeSciences Repairs department for detailed inspection and servicing. Request that Integra NeuroSpecialists perform routine inspections of the device.

Recommended Frequency Once / year Twice / year

In the absence of proper care and servicing of the device, negative effects may be seen after repeated processing over time which may lead to reduced performance. Contact information: See the Service and Repair section for contact information on how to return your device for periodic servicing and to request periodic inspections. See Inspection and /or Service notes section for routine checks to be performed on the device. NOTE: Any serious incident that has occurred in relation to the device for the user and/or the patient should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

Device Disposal NOTE : Follow hospital procedures for disposal of this device. 15

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Inspection of Components A routine inspection of the components of the MAYFIELD Infinity 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. 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.

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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

Auxiliary Side Rail

Locking Lever Opened

Tension Adjustment Knob

Figure 9 Opening Locking Lever

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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

Decrease Locking Lever Tension

Increase Locking Lever Tension

Figure 10 Adjustment Knob 4. 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 confirm 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. 18

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Integra Standard Warranty INTEGRA warrants to the original purchaser only that each new MAYFIELD 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 first 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 office. If purchaser seeks to invoke the terms of this warranty, the product must be returned to INTEGRA at its home office. 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 affect 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 modified in any way, except as a result of a writing signed by an officer of INTEGRA. These limitations on the creation or modification of this warranty may not be waived or modified orally or by any conduct.

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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: 877-444-1114

U.S. Patent 7,552,492

Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. MAYFIELD is a registered trademark of SM USA and is used by Integra under license. Endozime is a trademark of Ruhof Corporation. Renu-Klenz is a trademark of Steris Corporation.

©2021 Integra LifeSciences Corporation. All Rights Reserved.

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451A2079 Rev CA 2021-01 0646482-3