Budde Halo Radiolucent Retractor System Instruction Manual

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 Catalog number

Date of manufacture (YYYY-MM-DD)

Lot number

Serial number

4

EN – ENGLISH

ENGLISH

OPTIONAL ACCESSORIES: 12” (300 mm) Halo Flex Arm-TI

Description

TEW Hooked Micro Retractor Blades-2mm-SS 438A1151A,B,C,&D

The Budde® Halo Radiolucent Retractor System (REF A1096) was designed for use in all intercranial procedures where retraction of delicate brain tissue is required. The Budde Halo Radiolucent Retractor is used in conjunction with MAYFIELD® Radiolucent Skull Clamps (REF A1058, A2002 & A2114). The Budde Halo Radiolucent Retractor is attached to the skull clamp after the sterile draping process is complete.

443A1070B

TEW Hooked Micro Retractor Blades-4mm-SS 438A1152A,B,C,&D Budde Tapered Retractor Blades-SS TEW Serrated Micro Retractor Blades-2mm-SS 438A1155A,B,C,&D

The Budde Halo Radiolucent Retractor includes:

TEW Serrated Micro Retractor Blades-4mm-SS 438A1157A,B,C,&D

A. Halo Ring 443A1000 1 each B. 9” (229 mm) Halo Flex Arm-TI 443A1070A 3 each C. Rod Support Clamp Assembly 443A1060 2 each D. Radiolucent Support Rod 443B1052 2 each E. Halo Pattie Tray-SS 438A1037 1 each F. Halo Mini Vise-SS (not shown) 438A1140 1 each G. Halo Adjustment Wrench (not shown) 443A1004 1 each H. Halo Poly Vac Sterilzation Case (not shown) 443A1005 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. 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: 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.

Figure 1 Retractor Blades: I. Budde Curved Retractor Blades-SS 438A1077A,B,C,D,&X 2 each

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.

J. TEW Micro Retractor Blades-2mm-SS (not shown) 438A1082A,B,&C 1 each

Instructions for Use

K. TEW Micro Retractor Blades-4mm-SS (not shown) 438A1083A,B,&C 1 each

The following assembly instructions are for attachment of the Budde Radiolucent Halo Retractor to a MAYFIELD Skull Clamp, most likely a MAYFIELD Radiolucent Skull Clamp.

L. Samy Vascular Retractor Blades 438A1192A & B,438A1193A & B, 438A1194A & B (not shown) 1 each

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. 5

EN – ENGLISH PRE-ASSEMBLY Assemble the two halo half rings by inserting the halo knob into open side of half ring.

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 Clamps to allow the support rods to slide freely.

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.

5. When correct position of the Halo Ring is achieved, tighten all four locking ring nuts securely with the wrench. Tighten the locking ring nuts of the Support Clamps first, and then tighten those on the Halo Ring.

NOTE: The halo half ring that does not include the support rod attachments is the ‘handrest’ side of the halo.

6. Adjust the built-in handrest section of the Halo Ring to the desired angle to maximize the operative field by turning the halo hinge thumbscrew counter-clockwise, and then tighten the thumbscrews clockwise to secure the handrest. One half of the Halo Ring can be removed to provide even greater exposure to the operative site.

ASSEMBLY TO SKULL CLAMP 1. Locate the MAYFIELD Skull Clamp under the sterile surgical drape. Attach the Radiolucent Halo Support Clamps over the sterile drape on the uprights of the skull clamp (Figure 2). The Clamps should point outward with the locking ring nut in an upward or downward position. Tighten the Support Clamps by turning the Support Clamp’s locking knob clockwise.

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.

NOTE: The compression ball should be centered within the locking ring nut to accept the Radiolucent Halo Support Rod.

7. Attach Halo Retractor Arms. Openings for the Retractor Arms are located in the center of each half of the Halo Ring.

Figure 2 Figure 4

2. Attach both Radiolucent Halo Support Rods to the Halo Ring by seating the ball of the Support Rods into the key way receptacles of the Halo Ring (Figure 3). Finger-tighten the lock ring nuts by turning clockwise.

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 the chuck (Figure 5).

Figure 3 3. Insert the Halo Support Rods (which are now connected to the Halo Ring) into the compression balls of the Halo Support Clamps. Finger-tighten the locking ring nuts of the Halo Support Clamp by turning clockwise.

Figure 5 6

EN – ENGLISH hand to turn the dovetail block clock-wise to tighten or counterclockwise to loosen. This action is similar to screwing a nut onto a bolt (Figure 7).

Figure 6 NOTE: Groove on stem must align with centering dot on chuck (for metal reusable blades) (Figure 6). 9. After locating Retractor Arms in the desired positions, lock them in place securely by turning the thumbscrew clockwise.

Figure 8 Use of System with Digital Subtraction Angiography The surgeon should position the skull clamp and base unit to minimize the mass of radiolucent material the C-arm’s beam must penetrate. Minimal artifact may be seen.

10. To make adjustments in the Retractor Arm position, loosen the “T”-handle until the arm becomes limp. Position the retractor as desired. The Retractor Arm may be positioned over or under the radiolucent halo ring. Retighten the “T”-handle. Once the retractor blades are set in the field and only subtle movements are needed, no readjustment of the “T”-handle is required.

NOTE: Digital Subtraction must be used. Follow directions of the angiographic equipment manufacturer.

CAUTION: Forcing the metal 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 tend to drift. After a period of time, drifting may occur even though the “T”-handle is made tight. This is usually due to the drawbar threads becoming worn, necessitating replacement of the part.

Cleaning and Sterilization 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 Radiolucent Retractor System (REF A-1096) should be steam sterilized before each use. NOTE: Do not disassemble retractor arm assembly (REF# 443A1070A). Loosen tension on the retractor arm’s adjustment knob, which will allow for ample separation of the individual ball joints for appropriate cleaning.

Retractor Arm Maintenance (Metal Reusable Arms): Should the Retractor Arm seem less stiff than desirable, even after full tightening of the “T”-handle, the problem may be corrected as follows: 1. Turn the “T”-handle maximally counterclockwise, making the arm fully loose.

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 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 damge due to use. • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). See contact information below.

Figure 7 2. While holding the chuck assembly with the ring and little fingers of your non-dominant hand, hold the last joints of the Retractor Arm, closest to the dovetail block between the forefinger and thumb of the same hand. Use the dominant 7

EN – ENGLISH INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent

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

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 belw and set washer machine to these exact parameters:

Preparation for Cleaning • Disassembly is required. Disassembling Equipment

Inspecting for Cleanliness

Disassemble components as normal and place back into tray.

Before sterilizing look into tray for any sign of organic debris.

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

Phase

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.

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

60.0°C (140°F)

Neutral pH detergent (e.g. Renu-Klenz™, Steris, Ratio 1:256)

Rinse 1

0:30

Hot water

N/A

Thermal Rinse**

2:00

82.2°C (180°F)

N/A

**Optional phase for disinfection of components - minimum water temperatures as indicated or per worker manufacturer specifications for the theral 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.

Repeat process if any soil is detected.

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.

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.

Repeat process if any visible soil is detected.

Optional Automatic Wash / Disinfect

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.

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.

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

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. 8

EN – ENGLISH

Preparation for Sterilization Loosen and remove the threaded components as shown below (figures 9 - 11)

Figure 9

Remove fitting and place loose in sterilization tray

Figure 12 (Top tray)

Figure 10 Remove fittings and internal compression balls and place in sterilization tray

Figure 13 (Bottom tray)

Sterilization 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.

Figure 11

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.

Loosen, but do not disassemble, all remaining threaded components to allow best steam penetration. Ensure sterilization tray lid will clamp closed after loosening. Place components in tray as shown in the below figures 12 and 13:

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. Preparation for Cleaning • Disassembly is required. See manual wash instructions. Cleaning • See manual wash instructions. 9

EN – ENGLISH 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. Packaging • Wrapped – using wrappers designed for steam sterilization. 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. 3. Double wrap tray in CSR wrap, then steam sterilize at 132°C high vacuum (2 psia) for 4 minutes. The sterilization is followed by a 60 minute minimum drying cycle. 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. Remove tray from sterilizer following hospital procedure and allow cooling. NOTE – Allow components to reach room temperature before use.

Figure 15 (Place Compression Ball into threaded cavity)

Storage • Store equipment according to hospital procedures. Contact Information • Please call 1-877-444-1114 or 513-533-7979 for Customer Service. Figure 16 (View of properly positioned Compression Ball)

Repair Department can be reached through these numbers.

Post Sterilization Reassemble components. See the figures 14 - 18 below for proper reassembly of the Rod Support Clamp Assembly #443A1060 (2 each).

Figure 17 (Carefully position and thread insert into mating part)

Figure 14 (Disassembled Rod Support Clamp Assembly 443A1060 (2 each))

10

EN – ENGLISH • 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.

Figure 18 (Properly assembled Support Clamp Assembly 443A1060 (2 each))

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. 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.

Maintenance and Care To ensure proper function and to extend the like and performance of the equipment, lntegra LifeSciences recommend the following: Recommended Action

Recommended Frequency

Return the device to the lntegra LifeSciences Repairs department for detailed inspection and servicing.

Once / year

Request that lntegra NeuroSpecialists perform routine inspections of the device

Twice /year

ln the absences 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 lnspection and/or Service notes sect¡on for routine checks to be performed on the device.

Device Disposal

Service and Repair

NOTE: Follow hospital procedures for disposal of this device.

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

Integra Standard Warranty

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

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.

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

• 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. 11

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

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 U.S. Patent 7,232,411 Budde, 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. U.S. Patent www.integralife.com/patentmarking ©2021 Integra LifeSciences Corporation. All Rights Reserved.

451A1096 Rev CA 02/21 0845495-2 12

FR – FRANÇAIS

24

IT – ITALIANO

36

DE – DEUTSCH

Budde® Halo-nicht Röntgenopake Rektraktorsystem ( A1096) Gebrauchsanleitung

Hersteller: 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

37

DE – DEUTSCH

48

ES – ESPAÑOL

Sistema Retractor Radiotransparente Budde® Halo ( A1096) 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

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

49

ES – ESPAÑOL

60

NL – NEDERLANDS

Budde® Halo radiolucent retractorsysteem ( A1096) Gebruikershandleiding

Fabrikant: 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

61

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

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 U.S. Patent 7,232,411 Budde, 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. U.S. Patent www.integralife.com/patentmarking ©2021 Integra LifeSciences Corporation. All Rights Reserved.

451A1096 Rev CA 02/21 0845495-2 72