MAYFIELD Horseshoe Conversion System Instruction Manual

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EN – ENGLISH

MAYFIELD® Horseshoe Conversion Adapter ( REF A1109) MAYFIELD® Horseshoe Conversion Adapter with Knobs ( REF A1110) Instruction Manual

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 (France) Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, FRANCE Phone: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

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 Product complies with the requirements of directive 93/42/EEC 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 (YYYY-MM-DD) Lot number Serial number

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EN – ENGLISH

ENGLISH A. Torque Screw B. Horseshoe Conversion Adapter with Knobs A-1110 C. Horseshoe Headrest A-1011 D. 6" Transitional 41B1171

Description

The MAYFIELD® Horseshoe Conversion Adapters (REF A-1109, A-1110) were designed to allow for the attachment of the Horseshoe Headrest (REF A-1011) to attach to MAYFIELD Swivel adapters (REF A-1018, A-1064, or A-2008). Also, the Horseshoe Conversion Adapter with knobs (REF A-1110) allows for the attachment of Horseshoe Headrest (REF A-1012) to attach directly to the standard 6" transitional member (REF 41B1171). WARNING: Failure to read and follow instructions furnished in this product insert may result in serious patient injury.

C

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.

A

WARNING: Do not alter the design of the device in part or whole as serious patient injury could result.

B Figure 2

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

Instructions for Use

Horseshoe Conversion Adapter (A-1109) 1. Mount the Horseshoe Conversion Adapter to Swivel adapter using the torque of the swivel adapter.

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. A. Horseshoe Conversion Adapter B. Swivel Adapter C. Horseshoe Headrest

D

2. Mount the Horseshoe Headrest (A-1011) to the Horseshoe Conversion adapter using the torque screw on the Horseshoe Headrest. Horseshoe Conversion Adapter with Knobs (A-1110) 1. Screw the torque screw on the large sunburst into the sunburst of the Horseshoe Headrest (A-1012).

A-1109 A-1018, A-1064, A-2008 A-1011

2. Screw the torque screw on the small starburst into the 6" transitional (41B1171). WARNING: Before using this product, carefully read the product insert for correct usage and warnings associated with any other desired support equipment to be used with this product prior to its use.

C

CAUTION: Always be sure the two sets of sunburst teeth mesh properly, (as shown in Figure 3). Failure to do so may result in damage to the device.

A B

Figure 1 4

EN – ENGLISH

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.

Figure 3

Cleaning and Sterilization:

After each use, thoroughly clean and wipe the unit with antiseptic solution. 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. • 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. 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 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 • Follow health care facility protocol for safe containment and transport to the decontamination environment. • It is recommended that devices are cleaned immediately after use.

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.

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EN – ENGLISH

INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent

Maintenance and Care

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

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 loosing 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:

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 Twice / year device

Phase

Time (Min.)

Water Temperature

Detergent and Concentration

Pre-wash 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)

See Inspection and/or Service notes section for routine checks to be performed on the device.

Rinse 1

0:30

Hot water

N/A

Device Disposal

Thermal Rinse**

2:00

82.2ºC (180º F)

N/A

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.

NOTE: Follow hospital procedures for disposal of this device.

Integra Standard Warranty

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

INTEGRA LIFESCIENCES CORPORATION (“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.

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.

• 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.

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.

• 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.

Repeat process if any visible soil is detected.

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EN – ENGLISH

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. 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.)

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 which 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, EXPRESSED OR IMPLIED, AND 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.

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

INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY AS WELL AS ANY EXPRESSED 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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EN – ENGLISH

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 (France) Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, FRANCE Phone: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

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.

©2018 Integra LifeSciences Corporation. All Rights Reserved. 451A1109 Rev. DA 03/18 0690933-2

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NL – NEDERLANDS

MAYFIELD® conversieadapter voor hoefijzervormige hoofdsteun ( REF A1109) MAYFIELD® conversieadapter met knoppen voor hoefijzervormige hoofdsteun ( REF A1110) Gebruikershandleiding

Fabrikant: 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 (FRANKRIJK) Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, FRANKRIJK Phone: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

EN – ENGLISH

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 (France) Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, FRANCE Phone: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

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.

©2018 Integra LifeSciences Corporation. All Rights Reserved. 451A1109 Rev. DA 03/18 0690933-2

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