MAYFIELD Skull Clamp ( Modified )Instructions Manual Rev DAA Jan 2021

English - Figure 1 1. Plunger 2. Extension assembly 3. 80psi torque screw 4. Rocker arm (rotates 360°) 5. Index knob 6. Skull clamp base

Italiano - Figura 1 1. Stantuffo 2. Gruppo di estensione 3. Vite di regolazione 80psi 4. Bilanciere (ruota di 360°) 5. Pomello di serraggio 6. Base della testiera

1

6 2 3

Deutsch - Abbildung 1 1. Kolben 2. Extension assembly Figure 1 3. 80psi Befestigungsschraube 4. Dreharm (um 360° drehbar) Français - Figure 1 5. Index-Knopf 1. Plongeur 6. Basiseinheit der Schädelklemme 2. Ensemble rallonge 3. Vis de réglage de 80psi 4. Basculeur (tourne sur 360°) 5. Bouton de serrage 6. Base de clamp crânien

4

5

Español - Figura 1 1. Mecanismo de liberación 2. Conjunto extensible 3. Manivela del tornillo 80psi 4. Brazi giratorio (rota 360°) 5. Tirador 6. Base de clamp craneal

Netherlands - Figuur 1 1. Plunjer 2. Verlengconstructie 3. 80 psi koppelschroef 4. Zwenkarm (draait 360°) 5. Borgknop 6. Schedelklemvoet Svenska - Figur 1 1. Kolv 2. Förlängningsenhet 3. 80 psi vridskruv 4. Svängarm (kan rotera i 360°) 5. Indexvred 6. Bas till skallklämma 80

80 lbs MAX

40

2

1

60

20

Figure 3

Figure 2 English - Figure 2 1. Correct 2. Incorrect

Français - Figure 2 1. Correct 2. Incorrect

Italiano - Figura 2 1. Corretto 2. Errato

Deutsch - Abbildung 2 1. Richtig 2. Falsch

Español - Figura 2 1. Correcto 2. Incorrecto

Nederlands - Figuur 2 1. Goed 2. Fout Svenska - Figur 2 1. Rätt 2. Fel

Figure 5 Figure 4

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 accompanying documents

Product complies with the requirements of MDR 2017/745

Manufacturer Authorized Representative in the European Community

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

MR

This device is not indicated for use in the MR environment

Catalog number REF

Date of Manufacture

Lot Number LOT Serial Number SN Medical Device

Table 1: MAYFIELD® Skull Clamp Positioning* Diagram

Correct

Figure A

Incorrect

Figure B

Correct

Figure C

ENGLISH:

* 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 looking at the above chart, the ovals representing the patient’s head have centerlines drawn on them. The diagrams show selected samples 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 single-pin line of direction to obtain the highest degree of stability.

ENGLISH

such as scalp lacerations, skull fracture or even death.

Indications for Use/Intended Purpose/ Description

WARNING: Non-Mayfield branded products used with MAYFIELD products - We caution that we have only validated MAYFIELD products used in conjunction with the MAYFIELD product line, and as a result, cannot advise you whether suppliers’ products would work properly with the MAYFIELD line of products.

The Modified MAYFIELD® Skull Clamp (REF A-1059) is designed to give rigid skeletal fixation and allow the surgeon more freedom in positioning the fixation pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arm, which rotates 360 degrees, making application much easier. The swivel rocker arm can rotate 360 degrees under full skeletal pressure after pin impingement, making final patient positioning safer and easier. The Modified MAYFIELD Skull Clamp requires the use of three (3) each MAYFIELD Skull Pins.

MAYFIELD Skull Pins

MAYFIELD Reusable Adult Skull Pin (REF A-1047) MAYFIELD Reusable Child Skull Pin (REF A-1048) MAYFIELD Disposable Adult Skull Pins (REF A-1072 - Plastic) MAYFIELD Disposable Adult Skull Pins (REF A-1083 - Steel) MAYFIELD Disposable Child Skull Pins (REF A-1084 - Steel) The MAYFIELD Ultra Base Unit (REF A-2101) and the MAYFIELD Ball Socket Swivel Adaptor (REF A-1064), the MAYFIELD Swivel Adaptor (REF A-1018), or the MAYFIELD Tri-Star Adapter (REF A-2008) are required when using the Modified MAYFIELD Skull Clamp. In addition, the MAYFIELD Crossbar Adaptor (REF A-1015) is required for use of the skull clamp for the sitting position.

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. WARNING: Failure to read and follow instructions furnished in this product insert may result in skull pin slippage and serious patient injury,

WARNING: This device is not intended for use in or near the vicinity of a strong magnetic field. (MRI) WARNING: Do not alter the design of the device in part or whole as serious patient injury could result.

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.

Instructions for Use

1. Mounting of MAYFIELD Skull Pins NOTE: Use only MAYFIELD brand skull pins with this skull clamp. a. Push skull pins as far as possible into pin holder receptacles on skull clamp. CAUTION: Inspect reusable skull pins before each use. To maintain proper fixation, pins should be of equal length. Broken, dull, or bent pins should be replaced. It is recommended that spare pins always be kept available.

WARNING: Never resharpen skull pins. Dull or bent pins should be replaced. NOTE: When using MAYFIELD Disposable or Reusable Skull Pins, follow instructions supplied with the product. 2. Fixation to Patient 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. WARNING: MAYFIELD Skull Clamp fixation devices 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. WARNING: The skull clamp must be applied along the centerline 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 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. a. Position the patient so that the two pins on the rocker arm of the skull clamp are equidistant from the centerline of the head (see Figure 2). CAUTION: Avoid the areas of the frontal sinus, temporal fossa, major blood vessels, nerves, previously restored or abnormally thin bone. b. Pull the plunger out and slide the two halves of skull clamp apart to adjust to proper width. c. Place the clamp in the desired position, normally

perpendicular to the floor for supine or prone patient positions and parallel to the floor for sitting patient positions (see fig. 6). d. The rocker arm is locked in place by rotating the index knob clockwise 60 degrees until the arrow on the index knob is aligned with the arrow on the aluminum arm. The rocker arm is now fully locked (See Service Note 2). e. Seat the skull pins securely into the cranial table. Skull pins should enter the scalp at a 90 degree angle, perpendicular to the head. NOTE: The single pin holder and torque screw give the surgeon a visual readout of 20/40/60/80 pounds of clamping force (see fig. 3). f. Clamping force is increased by turning the torque screw clockwise (See Service Note 3). Turn the torque screw to the desired graduation, then back off one quarter turn. NOTE: A minimum of 60 lbs. of pressure must be applied to the skull clamp. An additional pressure range reaching 80 lbs. is available if desired. WARNING: Pressure in excess of 80 lbs. is NOT RECOMMENDED. 3. Mounting of the Skull Clamp a. Insert threaded screw of small sunburst fitting on the swivel adaptor into the threaded hole of the MAYFIELD Base Unit’s Transitional Member. b. Turn the mounting knob clockwise and tighten. c. Insert torque screw of the large sunburst ratchet on the swivel adaptor into the threaded hole on the skull clamp. d. Turn the torque screw clockwise and tighten. Make certain to securely attach the base unit to the operating room table. 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.

CAUTION: Before fully tightening, always be certain that the sunburst teeth of the Swivel Adaptor and the Transitional Member fittings are the same size and mesh properly. Failure to do so may damage fittings. (Figure 4 shows typical sunburst connection and proper meshing of teeth).

• Channels and crevices found on this device require particular attention during cleaning. • Pay special attention to the water quality used throughout reprocessing. Hard water can damage the surface of the equipment. Avoid using hard water. Instead use purified water unless otherwise specified.

Service Notes

Limitations on reprocessing • Repeated processing has minimal effects on these devices. Product life is normally determined by wear and damage due to use. • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). See contact information below.

1. A routine check made well before each case will help avoid problems. The check should include the following: Check the plunger locking the ratchet arm in place for movement as follows: a. Remove the ratchet arm and hold the body with the release mechanism pointed toward the floor. b. Apply pressure upward while looking for movement. If the release mechanism moves 1.6mm or more, the unit should be returned for service. 2. While rotating the rocker arm 360 degrees lock and unlock the index knob. To ensure proper locking engagement, the knob must always turn a minimum of 60 degrees. If it does not lock, a slight additional rotation of the rocker arm should allow the locking mechanism to engage. If difficulties are encountered, the unit should be returned for service. 3. With the skull pin removed from the 80 psi torque screw, apply as much force as possible over the hole and check for movement of the index shaft. If rubber protrudes from around the shaft, the unit should be returned for service.

Cleaning and Sterilization DO NOT STEAM STERILIZE ! Plastic components may be damaged by heat.

Manual Wash CAUTIONS • Alkaline and highly acidic detergents and solutions cause damage to the devices.

INSTRUCTIONS Containment/Transportation • Follow health care facility protocol for safe containment and transport to the decontamination environment. • It is recommended that devices are cleaned immediately after use. Preparation for Cleaning • Disassembly is required. Disassembling Equipment

Inspecting for Cleanliness

Take the ratchet arm out of the skull clamp base by releasing the plunger knob. Keep lock knob in unlocked position. Remove 80 lb Pressure Knob.

Pay close attention for organic debris in the channel on the skull clamp base, hole passing through the starburst, pin carriers, and lock knob.

Cleaning – Manual Equipment: Water, Neutral pH Detergent, Soft Bristle Brush, Towels Method 1. Prepare neutral pH enzymatic detergent solution (e.g. Endozime® AW Triple Plus with APA (Ruhof), 1:128 ratio) according to detergent manufacturer’s instructions using lukewarm tap water.

2. Prepare equipment for soaking by disassembling removable parts and loosening connections. 3. Rinse equipment in warm water before placing into bath. 4. Completely soak equipment in water/detergent solution for 30 minutes maximum. 5. Clean thoroughly with a soft nylon bristle brush. NOTE – If possible, use a disposable brush. 6. Rinse in warm purified water until all visible substances and residual detergent are removed. NOTE – Make sure to give special attention to hard-to-reach areas. 7. Thoroughly dry equipment with soft clean towels and use medically compressed air if needed, to dry channels, crevices and lumens. 8. Inspect the equipment to make sure there is no visible organic debris or residue from cleaning agent.

INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent Method 1. Prepare equipment for cleaning by disassembling removable parts and loosening connections. 2. Rinse equipment in warm water before placing into washer. 3. Load device into the washer and place small parts in container or tray inside the washer unit in order to avoid losing small components. NOTE – Load devices carefully into washer in order to avoid collision. 4. Follow the instructions listed below and set washer machine to these exact parameters: Phase

Time (Min.)

Water Temperature

Prewash 1

4:00

Cold water N/A

Enzyme Wash

4:00

Hot water

Neutral pH enzymatic (e.g. Endozime® AW Triple Plus with APA, Ratio 1:128)

Wash 1

10:00

60.0ºC (140º F)

Neutral pH detergent (e.g. RenuKlenz™ , Steris, Ratio 1:256)

Rinse 1

0:30

Hot water

N/A

82.2ºC (180º F)

N/A

Repeat process if any soil is detected. Drying • Products should be dry at this point. If wetness or excess liquid is detected, dry with a soft clean towel. • Medically compressed air can be used if needed.

Optional Automatic Wash / Disinfect CAUTIONS • Alkaline and highly acidic detergents and solutions cause damage to the devices. • Channels and crevices found on these devices require particular attention during cleaning. • Pay special attention to the water quality used throughout reprocessing. Hard water can damage the surface of the equipment. Avoid using hard water. Instead use purified water unless otherwise specified. Limitations on Reprocessing • Repeated processing has negative effects on these devices and is not recommended for routine use. • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). See contact information.

Thermal 2:00 Rinse**

Detergent and Concentration

** Optional phase for disinfection of components – minimum water temperature as indicated or per worker manufacturer specifications for the thermal rinse cycle. NOTE – Any deviation from this guideline could result in damage to the equipment as well as improper cleaning results. Rinse with purified water. Do not perform if parameters cannot be achieved.

5. Remove from washer and dry completely if needed. 6. Inspect equipment to make sure there is no visible organic debris or residue from cleaning agent. Repeat process if any visible soil is detected. The life expectancy of the MAYFIELD products is expected to be as long as 7 years.

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 Repairs Once / year department for detailed inspection and servicing. Request that Integra NeuroSpecialists perform routine inspections of the device

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.

Warranty

INTEGRA LIFESCIENCES warrants that each new INTEGRA LIFESCIENCES product is free from defects in material and workmanship under normal use and service for a period of one (1) year (except as otherwise expressly provided as to accessory items) from the date of delivery by INTEGRA LIFESCIENCES to the first purchaser, but not beyond the “Expiration” date stated on any product labeling. MAYFIELD surgical devices are guaranteed to be free from defects in material and workmanship when used normally for their intended purpose. Any covered product that is returned to INTEGRA LIFESCIENCES for repair or replacement will be carried out at INTEGRA LIFESCIENCES’ sole discretion, at INTEGRA LIFESCIENCES’ expense, subject to the terms of this warranty and applicable agreements. Defective products should be returned promptly, properly packaged and postage prepaid. Loss or damage in return shipment to INTEGRA LIFESCIENCES shall be at CUSTOMER’s risk. IN NO EVENT SHALL INTEGRA LIFESCIENCES BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA LIFESCIENCES PRODUCT. Further, this warranty shall not apply to, and INTEGRA LIFESCIENCES shall not be responsible for, any loss arising in connection with the purchase or use of any INTEGRA LIFESCIENCES product which has been repaired by anyone other than an authorized INTEGRA LIFESCIENCES service representative or altered in any way so as, in INTEGRA LIFESCIENCES’ 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 LIFESCIENCES. THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AND ALL OTHER OBLIGATIONS OR LIABILITIES ON INTEGRA LIFESCIENCES’ PART, AND INTEGRA LIFESCIENCES NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA LIFESCIENCES’ PRODUCTS. INTEGRA LIFESCIENCES DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY, OTHER THAN THOSE EXPRESSLY SET FORTH IN THE PRODUCT LABELING, INCLUDING THE APPLICABLE USER INFORMATION. The foregoing shall not relieve INTEGRA LIFESCIENCES from strict tort liability, if otherwise applicable under governing law, for damages for personal injury caused by a product defect that made the product unreasonably dangerous at the time it was sold or placed.

Service and Repair

For service and repairs outside the United States, contact your local authorized Integra representative. Inside 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 (USA only) 513-533-7979

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Manufacturer: Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, OH 45227, USA Tel: 513-533-7979 Fax: 513-271-1915 integralife.com

EC REP 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 Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. MAYFIELD is a registered trademark of SM USA, Inc. 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.

451A1004 Rev. DAA 2021-01 0689695-2