MAYFIELD Horseshoe Headrest System Instruction Manual

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MAYFIELD® Horseshoe Headrest ( A1011) MAYFIELD® Swivel Horseshoe Headrest ( A1012) Instruction Manual

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➁ ➀ ➂ English - Figure 1 MAYFIELD Swivel Horseshoe Headrest-REF A-1012 1. Size Adjustment Knob 2. Pulley Bar 3. Pulley Bar Knob 4. Threaded Hole

➃

Figure 1

English - Figure 2 MAYFIELD Swivel Horseshoe Headrest, MAYFIELD Ball Socket Swivel Adaptor & MAYFIELD Base Unit

Figure 2

English - Figure 3 Proper meshing of sunburst teeth

Figure 3

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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 This device is not indicated for use in the MR environment

Catalog number Date of manufacture Lot number Serial number

Medical Device

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ENGLISH

Instructions for Use 1. Mount MAYFIELD Base Unit on to Operating Room Table

Indications for Use/Intended Purpose/Description The MAYFIELD® Swivel Horseshoe Headrest A-1011 and A-1012 are designed for the prone and supine positions.

2. Attach Swivel Adaptor to Transitional Member of Base Unit (for A-1012); Attach A-1011 Horseshoe Headrest to Transitional Member of Base Unit a. Insert the small ratchet torque screw on Adaptor or A-1011 Horseshoe Headrest into threaded hole on Transitional Member. b. Turn the torque knob of the Adaptor or A-1011 Horseshoe Headrest clockwise, tightening fully.

The MAYFIELD Ultra Base Unit (REF A-2101) and the MAYFIELD Ball Socket Swivel Adaptor (REF A-1064) are required when using the A-1012 MAYFIELD Swivel Horseshoe Headrest. No swivel adaptor is required for the A-1011 MAYFIELD Horseshoe Headrest. This system permits both lateral and vertical mobility for positioning the patient’s head. Replacement Gel Pads (REF 4-1-C-1444, Left; or 4-1-C-1445, Right) are available individually.

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 3 shows a typical starburstconnection and proper meshing of teeth.

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.

3. Mount Headrest on Adaptor (for A-1012) a. Insert torque screw of large ratchet into threaded hole on Headrest. b. Turn torque knob clockwise several turns. c. Position Headrest and tighten knob fully by turning clockwise. Be sure the two sets of sunburst teeth mesh properly (Figure 3).

WARNING: Failure to read and follow instructions furnished in this product insert may result in serious patient injury. WARNING: This device is not intended for use in or near the vicinity of a strong magnetic field. (MRI)

4. Adjust Headrest Pulley Rod Pulley rod can be positioned for traction, released and dropped out of the way, or removed. a. To loosen, turn pulley rod torque knob counterclockwise. b. Turn torque knob clockwise to fully tighten. Be sure the two sets of sunburst teeth mesh properly.

WARNING: Failure to properly position the patient and to fully secure all adjustment portions of this or any support device may result in serious patient injury.

5. Adjust Faceplates a. Turn torque knob counter-clockwise to loosen until the faceplates are moveable. b. Position faceplates to accommodate head size. c. Fully tighten torque knob by turning clockwise.

WARNING: Do not alter the design of the device in part or whole as serious patient injury could result. Make certain to securely attach the base unit to the operating room table. 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 - Gel Pad Attachment 1. Attach the Gel Pads onto the Horseshoe Faceplates as follows (Figure 4 depicts attachment of Gel Pad to Stationary Faceplate): • Slide the Gel Pad onto the Faceplate arm between tabs A and B until the end of the Gel Pad stops at the end of the Faceplate arm. 6

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• Pull tab C over the top edge of the Faceplate arm to lock into place.

Remove the Gel Pads from the Horseshoe Faceplates. For each Gel Pad, pull tab C over the top edge of the Faceplate arm (refer to Figure 4) and then slide the Gel Pad toward the end of the Faceplate arm until tabs A and B have cleared the end of the arm. CAUTION: Do not attempt to pull the Gel Pads away from the Faceplate arms. Damage to the Gel Pads may occur.

TAB C

CAUTION: Do not use an alcohol solution on the Gel Pads, immerse the Gel Pads in liquid, or expose the Gel Pads to heat via steam sterilization or any other means.

TAB A TAB B

Figure 4

Cleaning and Sterilization of Headrest After each use, thoroughly clean and wipe Headrest with an antiseptic solution.

Cleaning and Sterilization Group 1 - Non-Critical1, Heat Sensitive, pH Sensitive

The MAYFIELD Horseshoe Headrest should be thoroughly cleaned after each use. Clean all components, including the Gel Pads, with a neutral pH detergent. A soft brush can be used if necessary. Clean all components thoroughly to prevent traces of blood or debris from interfering with proper function of the device.

• Headrests Group 2 - Non-Critical1, Heat Sensitive pH Sensitive, Alcohol Sensitive • Gel Pads

Rinse thoroughly with de-ionized or sterile water to remove any residual detergent.

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CAUTION: Do not immerse faceplates in liquid or expose to heat.

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

DO NOT STEAM STERILIZE! Plastic components will be damaged by heat. WARNING: There is no validated automated cleaning/ washing/disinfection method for Group 2 (gel pads). A thorough, manual cleaning process is recommended for these devices. Automated cleaning methods may not be effective and may result in damage and reduced performance.

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.

Gel Pad Removal and Cleaning Prior to cleaning, disassemble components.

1 AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in Health Care facilities. 7

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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.

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.

Preparation for Cleaning • Disassembly is required. Disassembling Equipment

Inspecting for Cleanliness

Remove the gel pads from the unit by sliding off. Keep all joints in the unlocked position. Slide the adjustable headrest base until it comes apart.

Inspect the teeth of the starbursts and make sure to inspect all joints. Pay close attention to the area around the locking screw.

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.

Cleaning – Manual Equipment: Water, Neutral pH Detergent, Soft Bristle Brush, Towels

INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent

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.

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:

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.

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Phase

Time (Min.)

Water Temperature

Detergent and Concentration

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. Renu-Klenz™, Steris, Ratio 1:256)

Rinse 1

0:30

Hot water

N/A

Thermal Rinse**

2:00

82.2ºC (180º F)

N/A

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

** 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 department for detailed inspection and servicing.

Once / year

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. 9

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Integra Standard Warranty

WARRANTIES, EXPRESS OR IMPLIED INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, USAGE OR TRADE OR OTHERWISE, 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.

INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) warrants to the original purchaser only that each new INTEGRA product is free from manufacturing 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 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.

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 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

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 10

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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. 11

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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

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. 64

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