MAYFIELD Infinity Support System Instruction Manual

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MAYFIELD® Infinity Support System ( A1112) 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 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

WARNING: This device is not intended for use in or near the vicinity of a strong magnetic field. (MRI)

Indications for Use/Intended Purpose/ Description The MAYFIELD® Infinity Support System is a headrest support device that attaches to any MAYFIELD Base Unit Support Rods (A2101 or older models), creating a method for simultaneous application of a Headrest (adult, pediatric, or general purpose) and a Skull Clamp (ages 5+).

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: 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.

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.

Inspection:

Figure 1

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.

The MAYFIELD Infinity Support System (Figure 1) includes: A. Infinity Support Coupler 419B1010 1 each B. Horseshoe - Pediatric 419A1030 1 each C. Horseshoe - Adult 419A1031 1 each D. Horseshoe - General Purpose 419A1050 1 each E. Mini Gel Pad 438A1037 2 each F. Storage Case (not pictured) 419A1060 1 each

WARNING: Before using this product, carefully read the Instruction Manual for correct usage and warnings associated with any other desired support equipment.

Instructions for use: Mount the Coupler to the MAYFIELD Base Unit and O.R. Table

NOTE: All components are available as a system, or may be purchased separately.

1. Loosen the Post screws on each of the Coupler posts (Figure 2). 2. Slide the two rods of the MAYFIELD Base Unit into each receptacle of the Infinity Support before inserting into the O.R. Table Receptacles (Figure 3). Adjust the width of the Coupler posts as necessary.

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. 5

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Socket

Socket T-Knob Locking Knob Post Screw Posts

Gear Box Socket Sha

Figure 4

Crossbars

3. Lock the handles on the O.R. Table to secure the Base Unit. Slide Coupler to desired location and lock the Hold Down Screws.

Crank Handle

Figure 2

4. In order to raise or lower the Infinity Socket position, turn the Crank Handle on the Gear Box (Figure 2) clockwise or counterclockwise. To make lateral adjustments slide the Gear Box left or right on the Crossbars. To secure these positions, tighten the Locking Knob. The Locking Knob secures the Gear Box from moving in any direction and prevents the Crank Handle from movement.

Mount the Headrest to the Coupler Three styles of headrests are available: Horseshoe-Adult (419A1031)

Horseshoe-Pediatric (419A1030)

General Purpose (419A1050)

Figure 3 NOTE:

Replacement Gel Pads are available: Pediatric - Left 440C1011 1 ea Pediatric - Right 440C1012 1 ea Adult - Left 41C1444 Adult - Right 41C1445 Mini (for General Purpose) 419A1048 2 ea

The Coupler is typically positioned with the Locking Knob toward the O.R. Table, but may be reversed if necessary. The Coupler may also be inverted to place the Gear Box higher if required. (Figure 4)

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1 ea 1 ea

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1. After the MAYFIELD Infinity Coupler is mounted to the Base Unit and O.R. Table, a Headrest can be mounted to the Socket. Choose the appropriate Headrest and insert Ball in Socket - be sure to have the T-Knob loose (full counterclockwise position) before insertion of ball in socket. An audible “click” will be heard when the headrest is attached to notify user of engagement. 2. Position headrest and tighten the T-Knob (Figure 2) fully by turning clockwise.

CAUTION: Always be sure the T-Knob is locked to prevent patient head movement.

Figure 6

Adjust Faceplates of Infinity Horseshoe Headrests, Adult or Pediatric

Cleaning and Sterililzation After each use, disassemble all components of the system and thoroughly clean using a damp cloth and neutral pH detergent. Remove all traces of blood and debris and dry completely.

3. To adjust Faceplates, turn Faceplate Locking Knob counterclockwise to that Faceplates are moveable. Then, position Faceplates to accomodate head size. Fully tighten the Faceplate Locking Knob by turning clockwise. (Figure 5)

Group 1 - Non-Critical1, Heat Sensitive, pH Sensitive

Position Mini Gel Pads of Infinity General Purpose Headrest

• Headrests

4. Push the Mini Gel Pads as far as possible into the receptacles on the General Purpose Headrest. The gel Pads may be rotated into desired position. (MAYFIELD Skull Pins may also be inserted in receptacles for patients 5+ years of age.)

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

CAUTION:

Simultaneous Application of Skull Clamp (Figure 6)

Do not immerse gel pads in liquid or expose to heat. Do not steam sterilize gel pads.

5. While the patient’s head is positioned on a headrest, a Skull Clamp may be applied (ages 5+) simultaneously.

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.

CAUTION: The headrest may be adjusted while a Skull Clamp secures the patient’s head to relieve pressure. If this is necessary, be certain to manually hold the patient’s head to prevent slippage from the Skull Clamp.

DO NOT STEAM STERILIZE! Plastic components may be damaged by heat. 1

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

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Manual Wash

8. Inspect the equipment to make sure there is no visible organic debris or residue from cleaning agent.

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.

Repeat process if any soil is detected.

Limitations on reprocessing

CAUTIONS

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 • 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.

• 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.

INSTRUCTIONS Containment/Transportation

Limitations on Reprocessing

• Follow health care facility protocol for safe containment and transport to the decontamination environment. • It is recommended that devices are cleaned immediately after use.

• 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.

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:

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Phase

Pre-wash 1 4:00

Cold water

N/A

Enzyme Wash

Hot water

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

Wash 1

Maintenance and Care

Time Water Detergent and (Min.) Temperature Concentration 4:00

10:00

60.0ºC (140º F)

To ensure proper function and to extend the life and performance of the equipment, Integra LifeSciences recommends the following:

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

Rinse 1

0:30

Hot water

N/A

Thermal Rinse**

2:00

82.2ºC (180º F)

N/A

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.

** Optional phase for disinfection of components – minimum water temperature as indicated or per worker manufacturer specifications for the thermal rinse cycle.

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 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.

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.

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.

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

Lubrication It is important that metal movable parts be properly lubricated to keep these parts functional.

Inspection: Carefully inspect all parts after each cleaning to assure all components are in proper working con-dition.

CAUTION: Components should be returned for repair if wear is noted. The life expectancy of the MAYFIELD products is expected to be as long as 7 years. 9

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Integra Standard Warranty

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.

• 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.

Service and Repair

• 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.

In the United States, send all instruments for service or repair to:

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.

(Always include the purchase order number and a written description of the problem.)

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.

For service and repair outside the United States, contact your local authorized Integra representative.

Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227

Or phone: 513-533-7979 877-444-1114 (USA only)

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, 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, 10

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U.S. Patent 7,117,551 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.

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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.

451A1112 Rev CA 2021-01 0690591-2