MAYFIELD 2 Skull Clamp Instructions Manual Rev FAB June 2021

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MAYFIELD® 2 Skull Clamp (A3059) Instruction Manual

EN – ENGLISH United States, Canada, Asia, Pacific, Latin America USA 800-997-4868 i 888-980-7742 fax Outside USA 609-936-5400 i 609-750-4259 fax integralife.com Europe, Middle-East, Africa International: +33 (0)4 37 47 59 50 i +33 (0)4 37 47 59 25 fax Benelux: +32 (0)2 257 4130 i +32 (0)2 253 2466 fax France: +33 (0)4 37 47 59 10 i +33 (0)4 37 47 59 29 fax Germany: +49 (0) 2102 5535 6200 i +49 (0)2 102 5536 636 fax Switzerland: +41 (0)22 721 23 00 i +41 (0)22 721 23 99 fax United Kingdom: +44 (0)1 264 345 780 i +44 (0)1 264 363 782 fax integralife.eu Manufacturer: Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, OH 45227, USA. Tel: 1-513-533-7979 i Fax: 1-513-271-1915 www.integralife.com Integra LifeSciences Services Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France Tel: 33 (0) 4 37 47 59 10

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Meaning of Symbols used in this manual CAUTION Hazards which could result in equipment or property damage

WARNING! Hazards which could result in severe personal injury or death.

Caution, consult accompanying documents

Product complies with the requirements of MDR 2017/745

Manufacturer

Authorized Representative in the European Community

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

Catalog number

This device is not indicated for use in MR enviroment

Consult Instructions for Use

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. Allow your Integra Representative to inspect this device a minimum of two times per year to assist you in its proper function.

Figure 1 A3059 Skull Clamp 1. 356-N-Drehmomentschraube (454A1090) 1. 802.lbRatschenverlängerung Torque Screw (454A1002) 2. Ratchet Extension 3. Schwinge 3. Rocker Arm 4. Auslöseknopf (beidseitig) 4. Release Button (both sides) 5. Indexarretierknopf 5. Index Locking 6. Etike† mitKnob Seriennummer 6. Serial Number Label 7. Schädelklemmenbasis 7. Skull Clamp Base

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The MAYFIELD® 2 Skull Clamp is designed for use with the following equipment: A3100 MAYFIELD 2 Base Unit A3101 MAYFIELD 2 Base Unit A3102 MAYFIELD 2 Base Unit A3018 MAYFIELD 2 Standard Swivel Adapter A3008 MAYFIELD 2 Tri-Star Swivel Adaptor ALL Styles of MAYFIELD Skull Pins (A1072, A1083, A1084, A1119, A1120, A1121, A1122, A1047, A1048) Note: Use of MAYFIELD products and accessories in conjunction with other manufacturer’s stabilization equipment is not recommended.

SKULL SKULL CLAMP SKULLCLAMP CLAMP CC LL HEAD SKULL CLAMP SKULL CLAMP HEAD HEAD SKULL CLAMP SKULL SKULLCLAMP CLAMP C LC LLC CC LLHEAD HEAD HEAD HEAD HEAD

Correct Figure Correct AA A Correct Figure Figure Correct Figure Correct Figure Correct Figure Figure AAAA Correct Correct FigureA

Correct FigureBB Correct Figure Correct Figure Correct Correct Figure Figure BBBBBB Correct Figure Correct Figure Correct Figure

FF FFFF F

FF FFFF F

FF FFFF F

APPLIED FF==APPLIED

FFORCE APPLIED FFFFORCE F=F= APPLIED ===APPLIED APPLIED =APPLIED APPLIED FORCE FORCE FORCE

FORCE FORCE FORCE

HEAD HEAD CC LL HEAD HEAD C C HEAD HEAD HEAD L C LHEAD LC LLC CC LLSKULL CLAMP SKULL CLAMP C LC C CLLC LL SKULL CLAMP SKULL CLAMP SKULL CLAMP SKULL CLAMP SKULL CLAMP SKULL CLAMP

Figure Figure CC Incorrect Incorrect Incorrect Figure Figure Incorrect FigureC Figure CCC Incorrect Incorrect Incorrect Incorrect Figure FigureCC

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 2 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. The MAYFIELD 2 Skull Clamp is NOT Radiolucent.

WARNING! Failure to read and follow instructions furnished in this product insert may result in skull pin slippage and serious patient injury, such as 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 validated 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 warranty 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. Do not use Skull Clamps to exert excessive traction during a procedure. Patient injury could result. Skull Clamps are not intended for use in or near the vicinity of a strong magnetic field (MRI).

WARNING! This device is NOT Radiolucent.

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 2 Skull Clamp is designed to provide rigid skeletal fixation or stabilization in conjunction with the Base Unit (A3100, A3101, A3102) or any other standard aluminum MAYFIELD Base Units (A2009, A2101, A2102). The Skull Clamp is designed to allow the surgeon freedom in positioning the fixation pins. Avoidance of critical areas of the skull is facilitated by a swiveling rocker arm that also rotates 360 degrees. To simplify patient re-positioning after skull pin impingements, the rocker may be rotated without adjustment of the impingement force imposed by the Torque Screw (Single-pin side of skull clamp). The MAYFIELD 2 Skull Clamp (A3059) includes: Standard Adult Rocker Arm Standard Torque Screw (454A1002) Standard Ratchet Extension

Standard Torque Screw The torque screw can develop up to 80 lbs. (356 N) of force; graduated in 20 lb. (89 N) increments. The knob has eight facets. One facet is labeled with the “Caution” symbol.

Figure 2 Standard Torque Screw (454A1002)

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Mounting of MAYFIELD Skull Pins Note: Use only MAYFIELD brand Skull Pins with this Skull Clamp. Seat pins so there is no gap between the shoulder of the pin and the face of the socket

Figure 3 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 may 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.

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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.

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 lacerations, skull fracture, or even death.

1. Unlock the Index Locking Knob so the rocker arm can rotate freely 360 degrees. The Index Locking Knob is unlocked by rotating the knob to align the indicator with the open lock symbol; see Figure 4.

Closed lock symbol indicates locked position

Figure 4 Unlocking Index Locking 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 line on the gauge is 20 lbs or 89 N). 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. Depress both of the Release Buttons on the body-portion of the Skull Clamp (See Figure 5 below) to disengage the Ratchet Extension and slide the two halves of the clamp apart to allow placement around the patient’s head.

Figure 5 Disengaging Ratchet Extension

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4. Position the 2-pin rocker arm so the skull pins are equidistant from a center line of the head. (see Figure 6). 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. Note: Line of pins do NOT fall on the line of the center of Patient’s Head

Note: Line of pins are the same as the center of Patient’s Head

Correct

Incorrect Figure 6 Positioning Rocker Arm Skull Pins

WARNING! 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.

WARNING! 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:

Torque Screw Line Indicator

Clamping Force

1

20 lbs. (89 N)

2

40 lbs. (178 N)

3

60 lbs. (267 N)

4

80 lbs. (356 N)

Table 2 Torque Screw Line Indicator/Clamping Force

Figure 7 Standard Torque Screw

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. 7. Once the force is applied to the clamp and the patient is positioned for surgery, the Index Locking Knob should be turned to the locked position shown in Figure 4.

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

CAUTION! Over-tightening the Index Locking Knob can result in damage to the skull clamp.

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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 MAYFIELD 2 Base Unit (A3100, A3101, A3102), should be attached to the operating room table with the Locking Handle unlocked and the Swivel Adaptor loose. In the event that other MAYFIELD Base Units (A2009, A2101, A2102) are going to be used with the Skull Clamp, be sure to also assemble a Swivel Adaptor (A1018, A2008) to complete the support system for the Skull Clamp. Make certain to securely attach the base unit to the operating room table. 2. The attached but loose components of the Base Unit should be brought up for attachment to the Skull Clamp. • I nsert the mounting screw of the large starburst of the Swivel Adaptor into the large starburst of the Skull Clamp. • T  urn the handle clockwise and tighten. • C  are should be taken to maintain the position of the patient’s head as requested by the surgeon. 3. After securely fastening the Skull Clamp to the Swivel Adaptor turn the Index Locking Knob to the locked position. Continue by checking all the locking knobs and locking handles of the Adaptor and Base Unit making certain all starburst teeth are meshed (where applicable) on all joints of the Base Unit after adjustments are complete.

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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 8 shows a typical starburst connection and proper meshing of teeth.

Proper Meshing of Teeth

Figure 8 Mounting Skull Clamp

Maintenance, Care and Service Notes: Maintenance and Care: To ensure proper function and to extend the life and performance of the equipment, Integra LifeSciences recommends the following: Recommended Action

Recommended Frequency

Return the device to the Integra LifeSciences Service and Repairs Department for detailed inspection and servicing

Once/ year

Request that Integra Neuro-specialists perform routine inspections of the device

Twice/ year

Note: In the absence of proper care and servicing of the device, negative effects may be seen after repeated reprocessing 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. 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. 15

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

Service Notes: A routine equipment inspection made well before each case will help avoid problems. This check should include the following: 1. Store the Skull Clamp with the Index Locking Knob in the UNLOCKED position. This practice will provide the best performance from the knob. 2. While rotating the rocker arm through 360 degrees, lock and unlock the Index Locking Knob. To ensure proper locking engagement, the Index Locking knob must always be turned to the lock position. If the Index Locking Knob stops short of the locked position, a slight additional rotation of the rocker arm should complete the internal alignment and allow the locking mechanism to engage. If difficulties are encountered, the unit should be returned for service. 3. Check the Ratchet Extension release buttons to be sure that they allow for the Extension to disengage freely. Press them and move the Extension out of the body portion of the clamp do this several times to make sure that it works smoothly and easily.

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Cleaning and Disinfection of the MAYFIELD 2 Skull Clamp Cleaning: Option 1: Manual Cleaning CAUTION! Care should be taken to read completely this section on Cleaning, Disinfection and Decontamination of your MAYFIELD 2 equipment. It is important to know what method of cleaning/disinfection is needed based on what type of debris exposure the equipment has received. This is especially important when there is the possibility of exposure to a persistent pathogen that is resistant to normal cleaning and disinfection methods. Equipment with this exposure should be processed per the steps in the Decontamination Section. Integra does not make any claims regarding the effectiveness of the decontamination processes listed in deactivating pathogens, but rather, we are indicating that the device can withstand these procedures with minimal loss of function. IMPORTANT: If the product has been exposed to persistent/ highly contagious pathogens1, DO NOT apply gluteraldehyde, alcohol or formalin to the device until the decontamination process is complete. (See Decontamination Section below for instructions) The following steps are recommended for Manual Reprocessing of the MAYFIELD 2 Skull Clamp (A3059). 1. Disassembly: Separate the Ratchet Extension from the body portion of the Skull Clamp.

WARNING! Visually confirm that there are no Skull Pins in the rocker arm or Torque Screw. It is recommended to completely remove the ratchet extension from the clamp before removing Skull Pins. • R  emove the Torque Screw from the Ratchet Extension. 2. Soak each component in a warm enzymatic solution (35°C-45°C) prepared in accordance with the manufacturer’s instructions for 30 minutes. 3.

Wash and Rinse: • S crub each component with a soft brush. The Skull Clamp can withstand detergents that fall within pH ranges of 3-11. • C  lean thoroughly to remove any traces of blood and/ or debris. This is to prevent such blood and/ or debris from interfering with function or movement. • I nspect all components to ensure each component is visibly clean. Repeat as needed. • R  inse thoroughly with clean water (e.g. deionized water) to remove all traces of detergent.

1

P ersistent pathogens are resistant to deactivation by normal disinfection procedures and may require more aggressive treatment to achieve disinfection. See guidelines in Decontamination section for recommended procedures.

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WARNING! Use of highly alkaline detergents/ agents will cause a material degradation if present during autoclaving. Ensure device is thoroughly rinsed and all detergents are removed prior to use. 4. Dry all components with a clean, soft towel. 5. Re-assembly: After components are completely dry, re-assemble the components, leaving the Skull Clamp ready for the next use. • T  he Index Knob should be in the UNLOCKED position. • T  he Torque Screw should be inserted with the first thread showing. • T  he Ratchet Extension should be inserted into the body portion of the Skull Clamp.

Option 2: Automatic Wash Cycle CAUTION! Any deviation from this guideline could result in damage to equipment as well as improper cleaning results. 1. Disassemble the device as indicated in the Option 1 Manual Cleaning section of the MAYFIELD 2 Skull Clamp. 2. Rinse components under warm tap water prior to placing in washer. 3. Arrange device in a way to avoid contact between components. 4. Select instrument cycle and ensure proper programming. (Reference Table 3) Phase

Time in minutes

Pre-Wash 1

04:00

Water Temperature Detergent type & Concentration Cold tap H2O

N/A

Enzyme Wash

04:00

Hot tap H2O

Neutral pH enzymatic detergent (e.g. Endozime® AW Triple plus w/ A.P.A.), 1:128 ratio

Wash 1

10:00

60° C

Neutral pH cleaner, concentrated (e.g. Renu-Klenz™) 1:256 ratio

Rinse 1

00:30

Hot tap H2O*

N/A

Thermal Rinse**

02:00

82.2° C

N/A

Table 3 Instrument Cycle * No limit on tap water temperature. ** Optional phase for disinfection of components - minimum water temperature as indicated or per washer manufacturer specifications for the thermal rinse cycle.

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5. Remove from washer and dry with a clean, soft towel. 6. Inspect all components to ensure there is no visible organic debris or residue from cleaning agent. Repeat process if any visible soil is detected.

Additionally Validated Cleaning Cycles Wash (Pre-Wash)

Temperature Hold Time

Cold water from building supply (less than 110° Or 43°C)/4 min.

50°C/7 min

93°C

90°C

1 or more min.

1 or more min.

(Drying) (Optional)

Detergent Treatment

(Rinsing)

Thermal Disinfection

Alkaline (e.g. neodisher® SeptoClean 1%)

Hot water from building supply/2 min.

Optional

90°C/2O min.

Neutral Enzymatic (e.g. Enzol® per manufacturer’s recommendation)

Hot water from building supply/2 min.

Optional

90°C/20 min.

Table 4 Additionally Validated Cleaning Cycles

Optional Thermal Rinse: • A Thermal Disinfection rinse may be added after the first rinse cycle as indicated in Table 3.

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Disinfection: The MAYFIELD 2 Skull Clamp must be thoroughly cleaned after each use. Where possible, keep the soiled areas moist until the disinfection process can be initiated. Disinfection of device components following normal usage may be achieved using the following methods:

Option 1: Thermal Rinse: A Thermal Disinfection rinse may be added after the first rinse cycle as indicated in Table 3. See Cleaning section.

Option 2: Chemical / Bleach Soak: WARNING! Bleach solutions produce chlorine gas. Prepare in a well-ventilated area. Note: Hypochlorite potency decreases as bleach ages. Use only recently purchased/ opened bleach to prepare disinfection solutions. Do not use pre-diluted bleach. Prepare a new bleach solution for each application. Hypochlorite (Bleach) mixing guidelines to obtain 20,000 ppm solution: Bleach concentration

Preparation Instructions

4.5%

Pour 4 units of bleach into 5 units of water

5%

Pour 2 units of bleach into 3 units of water

6%

Pour 1 unit of bleach into 2 units of water Table 5 Hypochlorite Bleach Mixing Guidelines

1. Prepare a solution for general disinfection (See Table 5 and Table 6 guidelines for bleach solution) For General Disinfection • V  erify Concentration of base hypochlorite is 4.5% or more • M  ix ½ unit of bleach base solution into 10 units of water Table 6 Hypochlorite Bleach Mixing Guidelines 2. Disassemble the device. (see above disassembly instructions in Option 1 Manual Cleaning) 3. With the device disassembled, place components in a shallow pan and add enough bleach solution to cover the device completely. 4. Soak components for 15 minutes. 5. Rinse thoroughly with clean water. Ensure no bleach residue remains on components.

CAUTION! Use of highly alkaline detergents/ agents will cause a material degradation if present during autoclaving. Ensure device is thoroughly rinsed and all detergents are removed prior to use. 6.

Dry with a soft, clean towel.

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