Integra BUDDE Halo Retractor System REF A1040 Instruction Manual Rev DAA March 2018

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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, consult accompanying documents 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

REF

Catalog number

Date of Manufacture (YYYY-MM-DD)

LOT

Lot number

SN

Serial Number

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Description

E. Budde Curved Retractor Blades (2 ea.) 438A1077 (A,B,C,D&X) (Contains five 4” long blades ranging in width from 1/4” to 3/4”)

The Budde® Halo Neurosurgical Retractor System (REF #A1040) was designed for use in all intracranial procedures where retraction of delicate brain tissue is required. The Budde Halo Retractor is used in conjunction with the MAYFIELD® Skull Clamps (REF# A1013, A1014, A1059, A1108, A2000, A3059) or the MAYFIELD Radiolucent Skull Clamps (REF# A1058, A2002, A2114). The Budde Halo Retractor attaches to the skull clamp after the sterile draping process has been completed.

F. 2mm Tew Micro Retractor Blades (1 ea.) 438A1082 (A,B&C) (Contains three 2 mm x 10mm blades ranging in lengths from 4 1/2” to 6 1/2”) G. 4mm Tew Micro Retractor Blades (1 ea.) 438A1083 (A,B&C) (Contains three 4 mm x 10mm blades ranging in lengths from 4 1/2” to 6 1/2”)

For those intracranial procedures in which a conventional skull clamp is not employed ( i.e. pediatric brain surgery), the Budde Halo Retractor is used in conjunction with the Budde Halo Side Rail Support (REF # A1067) to secure the system to the side rails of the operating room table. The Budde Halo Neurosurgical Retractor System includes: A. ContinuTracTM Halo Ring (1 ea.) 438B1178 B. Halo Support Bracket (2 ea.)

438B1010

C. Halo Support Rod (2 ea.)

438A1188

D. 9” (229mm) Halo Retractor Arm (3 ea.)

438A1011

H. Halo Pattie Tray (1 ea.)

438A1037

I. Halo Minivise (1ea.)

438A1140

J. Halo Adjustment Wrench (2 ea.)

438A1024

K. Sterilization & Storage Case (1 ea.) 438A1076 (not shown) L. Samy Vascular Retractor Blades (438A1192A & B, 438A1193A & B, 438A1194A & B) 1 each NOTE: All components are available separately. 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.

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

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1. Locate the MAYFIELD Skull Clamp under the sterile surgical drape. Attach the support brackets (REF# 438B1010) over the sterile drape around the uprights of the skull clamp. The brackets should point outward with the locking ring nut in an upward or downward position. Tighten the support brackets by turning the support bracket clamp’s locking knob clockwise (Figure 2).

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

NOTE: The compression ball should be centered within the locking ring nut to accept the Halo Support Rod (REF# 438A1188).

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. WARNING: Remove retractor blades from patient prior to transport or imaging. Unintentional movement of the blade against brain tissue may result in serious patient injury.

Figure 2

Instructions for Use

2. Attach both support rods to the halo ring by seating the ball of the support rods into the receptacles of the halo ring’s mounting brackets. Finger-tighten the lock ring nuts by turning clockwise (Figure 3).

The following assembly instructions are for attachment of the Halo Retractor to the MAYFIELD Skull Clamp (REF# A1059). Attachment to other model MAYFIELD Skull Clamps (REF# A1059, A1108 or A3059) or the MAYFIELD Radiolucent Skull Clamps (REF# A2114) follow the same assembly procedures. NOTE: The patient should be positioned in the MAYFIELD Skull Clamp and draped in the usual manner. From this point, the field is sterile. The entire assembly process shown is to be carried out using sterile technique.

Figure 3

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3. Insert the support rods (which are now connected to the Halo ring) into the receptacles of the compression balls for the Halo support bracket. Finger tighten the locking ring nuts of the support bracket by turning clockwise. (Figure 4).

5. When correct positioning of the Halo ring is achieved, tighten all four locking ring nuts securely with the wrench. Tighten the locking ring nuts of the support brackets first, then tighten those on the halo ring brackets. (Figure 6).

Figure 6

6. Adjust the built-in handrest segment of the Halo ring to the desired angle to maximize the operative field by turning the halo hinge thumbscrews counter-clockwise, then tighten the thumbscrews clockwise to secure the handrest. (Figure 7). The Halo ring can be folded back upon itself to create a second layer of retraction or open up the front half of the operative field for even greater exposure to the operative site (Figure 8).

Figure 4

4. With the four locking ring nuts finger-tightened only, movement of the support rod ball joints will allow precise positioning of the Halo ring over the operative site. The height of the ring over the field may be changed by loosening the locking ring nuts on the support brackets to allow the support rods to slide freely. (Figure 5).

Figure 7

Figure 5

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8. Attach the retractor blades to the retractor arms. Grasp the chuck on the retractor arm between the thumb and index finger, while other fingers grasp the remainder of the retractor arm. Slide the chuck forward and insert the stem of the retractor blade. Then release chuck. (Figure 10)

Figure 8

Figure 10

CAUTION: Always be sure the two sets of sunburst teeth on the halo’s hinge mesh properly. Failure to do so may result in damage to the device.

NOTE: Groove on stem must align with centering dot on chuck. 9. After locating retractor arms in the desired positions, lock them in place securely by turning the thumbscrew clockwise. (Figure 11)

NOTE: When positioning the patient for Posterior Fossa approaches with the patient in the Park Bench position, it is recommended that the halo ring’s adjustable segment be positioned to the inferior direction relevant to the patient. This allows the ring’s adjustable segment to be angled, so the halo ring can be lowered closer to the operative site and avoid the patient’s shoulder. 7. Attach retractor arms. Openings for the retractor arms are located on the halo ring directly under the two locating arrows. Insert the dovetail section of the retractor arm into the opening and slide into the groove (Figure 9).

Figure 11

10. To make adjustments in the retractor arm position, loosen the knob until the arm becomes limp. Position the retractor as desired. The retractor arm may be positioned over or under the split halo ring. Retighten the knob. Once the retractor blades are set in the field and only subtle movements are needed, no readjustment of the knob is required. CAUTION: Forcing the retractor arms to move against their present tension will cause the cable in the retractor arm to wear and possibly break. The ball joints will also become scored and the arm will

Figure 9

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tend to drift. After a period of time, drifting may be experienced even though the knob is made tight. This is usually due to the drawbar threads becoming worn, requiring a replacement of the part.

Flex Arm Maintenance

Should the retractor arm seem less stiff than desirable, even after full tightening of the knob, the problem may be corrected as follows: 1. Turn the knob maximally counterclockwise, making the arm fully loose (Figure 12).

Figure 13

NOTE: For those surgical procedures which require brain tissue retraction when a conventional skull clamp is not used, as in the case of pediatric patients or severe head trauma, the Budde Halo Brain Retractor should be used in conjunction with the Budde Halo Side Rail Support (REF# A1067). Please see the instruction manual for this product prior to use (Figure 14).

Figure 12

2. While holding the chuck assembly with the ring and little fingers of your non-dominant hand, hold the last joints of the flex arm, closest to the dovetail block between the forefinger and thumb of the same hand. Use the dominant hand to turn the dovetail block clockwise to tighten or counterclockwise to loosen (Figure 13). This action is similar to screwing a nut on to a bolt.

Figure 14

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Care and Cleaning

Preparation for Cleaning • Disassembly is required.

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. The entire Budde Halo retractor system (REF# A1040) should be steam sterilized before each use.

Table 1 Disassembling Equipment

Inspecting for Cleanliness

Disassemble Before sterilizing look components as normal into tray for any sign of and place back into tray organic debris.

NOTE: Do not disassemble retractor arm assembly (REF# 438A1011). Loosen tension on the retractor arm’s adjustment knob, which will allow for ample separation of the individual ball joints for appropriate cleaning.

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.

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. 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.

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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Optional Automatic Wash / Disinfect

Table 2

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.

4:00

Cold water N/A

Enzyme Wash

4:00

Hot water

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

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.

Inspection

Carefully inspect all parts after each cleaning to assure all components are in proper working condition. Pay particular attention to the retractor arm assemblies.

Table 2

Prewash 1

Detergent and Concentration

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.

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: Water Temperature

Water Temperature

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

INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent

Time (Min.)

Time (Min.)

Thermal 2:00 Rinse**

Limitations on Reprocessing • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). See contact information.

Phase

Phase

Detergent and Concentration

CAUTION: Components should be returned for repair if wear is noted.

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

Lubrication

It is extremely important that movable parts be properly lubricated to keep these parts functional. It is recommended that all components be immersed in a water-soluble lubricant prior to sterilization. 10

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Sterilization

3. Steam sterilize at 132ºC – 134ºC high vacuum (2psia) for 3-18 minutes, dry time: 90 minutes. Other time and steam temperature cycles may also be used. However, the user must validate any deviation from the recommended time and temperature. Follow the sterilizer manufacturer’s instructions for operation and loading of steam autoclave. 4. Drying - open the sterilizer door and allow device to cool for 30 minutes. Next, place cooled device on a wire rack or equivalent for 45 minutes.

CAUTIONS • Prolonged exposure time may affect product life. Carefully inspect for visible damage and malfunction after sterilization. • Channels and crevices found on this device require particular attention during cleaning. 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. INSTRUCTIONS Containment/Transportation • Follow healthcare facility protocol for safe containment and transport to the decontamination environment. • It is recommended that devices are cleaned immediately after use.

NOTE – Allow components to reach room temperature before use. Table 3 Steam Sterilization Validated Cycles Cycle Conditions

Sterilization Sterilization Dry time temperature Exposure (minutes) Time (minutes)

Wrapped, 132°C-134°C Pre-vacuum

3-18

Open Cool Door Down Phase (minutes) (minutes)

90*

30*

45*

Preparation for Cleaning • Disassembly is required. Please see manual wash instructions.

* Please follow the specified drying instructions to ensure device is completely dry.

Cleaning • See manual wash instructions.

Storage • Store equipment according to hospital procedures.

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

Contact Information • Please call 1-877-444-1114 or 513-533-7979 for Customer Service. Repair Department can be reached through these numbers.

Packaging • Wrapped – using wrappers designed for steam sterilization.

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:

Sterilization Equipment: Steam Sterilizer Method 1. Follow sterilizer manufacturer’s instructions for loading and operating the sterilizer. 2. Make sure direct steam exposure to all surfaces is possible. NOTE – Avoid heavy loads and overcrowding on sterilizer shelf/racks.

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 11

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Maintenance and Care

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.

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.

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, EXPRESSED 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.

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.

INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF 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.

Device Disposal

NOTE: Follow hospital procedures for disposal of this device.

Integra LifeSciences Warranty Statement

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. • 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 12

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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 (France) 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 50 Fax: +33 (0) 4 37 47 59 25 Budde, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ContinuTrac is a trademark of Integra LifeSciences Corporation. 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. 13

451A1007 Rev. DAA 03/18 0557736-3

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Sistema retractor Budde® Halo ( REF A1040/A1040A) Manual de instrucciones

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

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Budde® haloretractorsysteem ( REF A1040/A1040A) 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 Tel: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

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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 (France) 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 50 Fax: +33 (0) 4 37 47 59 25 Budde, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ContinuTrac is a trademark of Integra LifeSciences Corporation. 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.

451A1007 Rev. DAA 03/18 0557736-3