CRW Precision Arc Stereotactic System Operators Manual Rev H Sept 2014

WARRANTY 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 year from the date of delivery by Integrato 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 the sole discretion and expense of Integra, subject to the terms of this warranty and applicable agreements. 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 THE PART OF INTEGRA, AND INTEGRANEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA PRODUCTS. INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESS 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 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.

Definitions of Alerts Used in this Manual Warning: An operation or maintenance procedure, practice, condition, statement, etc. which, if not strictly adhered to, could result in injury, long term health hazard, or death of a patient or personnel. Caution An operation or maintenance procedure, practice, condition, statement, etc. which, if not strictly adhered to, could result in damage to or destruction of part or all of the device, or could result in displaying erroneous information. Note

An important point of interest or instruction which may simplify a procedure or prevent unnecessary labor.

TABLE OF CONTENTS

Chapter 1: About the CRW® Precision Arc Stereotactic System About this User’s Manual ... 1 About CRW System Compatibility... 1 Indications for Using the CRW System ... 1 Standard Stereotactic Procedures... 1 Contraindications for Using the CRW System... 2 Single Use Precautions ... 2 Accuracy of the CRW System ... 3 Using the CRW System with Electrosurgical Devices... 3 List of Symbols ... 4 List of CRW System Components... 6

Chapter 2: Unpacking the CRW® Precision Arc Stereotactic System About the Shipping Boxes ... 17 Box 1 of 2 - Components and Accessories ... 17 Box 2 of 2 - Sterilization Case ... 18 Unpacking the System ... 18 I. Unpacking Box 2 of 2 - Sterilization Case ... 18 II. Unpacking Box 1 of 2 - Components and Accessories ... 18

Chapter 3: Assembling and Configuring the CRW® Precision Arc Stereotactic System Assembling the Universal Compact Head Ring (UCHR)... 21 Attaching the Head Ring Screw Cross Bar (Optional) ... 22 Installing the Ear Bars (Optional)... 23 Assembling the HRAIM ... 27 Assembling the Localizer Frames ... 32 Assembling the BRWLF on the UCHRA or on the HRAIM ... 32 Assembling the Luminant on the UCHRA ... 33 Assembling the CRW Arc System... 34 Setting the Fixed Radial Distance for the Arc System Pointer ... 39 Setting the Fixed Radial Distance for an Instrument. ... 40 Selecting the Guide Tube and Reducing Tube/Bushing Combinations... 41 Attaching the Arc System to the Phantom Base... 42 Attaching the Head Ring to the Operating Table... 45

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Attaching the Universal Compact Head Ring (UCHRA) or the HRAIM to the Operating Table ... 45 Creating a Sterile Field ... 46 Attaching the Arc to the Head Ring... 48

Chapter 4: Scanning with the CRW® Precision Arc Stereotactic System Scanning the Luminant® Localizer Frame... 49 Manually Calculating the Luminant Target Positions... 49 Calculating Target Positions for Axial Scans ... 50 Calculating Target Positions for Coronal Scans ... 51 Calculating Target Positions for Sagittal Scans ... 53 Scanning the BRW Localizer Frame ... 54 Collecting CT Scan Rod Position Data ... 55

Chapter 5: Setting Targets on the CRW® Precision Arc System About the Arc System ... 57 About the Arc System Coordinates... 59 Measuring Arc System Coordinates with the Vernier Scale ... 60 Setting the Coordinates with a Vernier Scale ... 61 Setting the Probe Holder Approach Angle ... 62 Setting the Trunion Ring Approach Angle... 63 Transposing the Arc Rings... 63 Using Parallel Trajectories ... 64 Entering Multiple Targets Through a Single Burr Hole ... 64 Examples of Different Arc Orientations... 65

Chapter 6: Using the CRW® Precision Arc Accessories Tools for Calibration Guidance ... 67 Using the Micro Slide ... 67 Using the MicroDrive... 68 Visualizing Lateral Trajectories with the Trunion Reticles ... 69 Visualizing Anterior-Posterior Trajectories with the AP Reticles... 69 Clamping Patients to the CT Table... 70 Using the Geometric Phantom for Qualifying Transfer Accuracy ... 70

Chapter 7: Cleaning, Sterilizing, and Maintaining the CRW® Precision Arc Stereotactic System Cleaning the CRW Components ... 71 Cleaning the HRAIM and UCHR Components ... 71

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Cleaning the BRWLF and Luminant® Localizer Frames ... 71 Cleaning the CRW Precision Arc System... 72 Cleaning Miscellaneous CRW Parts... 72 Disassembling the CRW Precision Arc System Components... 73 Packing the CRW Components... 73 Sterilizing the CRW Components... 75 Parameters for Sterilizing the CRW Components ... 75 Summary of CRW Sterilization Procedures... 76 Maximum Sterilization Load (Accessories)... 78 Maintaining the CRW System ... 78 Preventing Equipment Loss... 78 CRW System Calibration ... 78 Returning the CRW System for Service or Maintenance ... 79

Index ... 81

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CHAPTER 1

ABOUT THE CRW® PRECISION ARC STEREOTACTIC SYSTEM About this User’s Manual... 1 About CRW System Compatibility... 1 Indications for Using the CRW System... 1 Contraindications for Using the CRW System... 2 Single Use Precautions... 2 Using the CRW System with Electrosurgical Devices... 3 List of Symbols... 4 List of CRW System Components... 6

About this User’s Manual This manual supports the CRW® Precision Arc Stereotactic System, and is not intended to be a clinical medical document. This publication details the mechanical/functional features of the system and describes how to properly assemble, use, sterilize and maintain the equipment in the system. Read and become familiar with these instructions before using the system in surgery.

About CRW System Compatibility The CRW stereotactic system is a target-centered system that can be configured to be CT-only or CT/MR compatible.

Indications for Using the CRW System Standard Stereotactic Procedures The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as:  Biopsy forceps  RF lesioning electrodes  Deep brain electrodes  Recording and stimulating electrodes  Hematoma evacuators  Endoscopes

Note

Localization is performed using CT or MR imaging.

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 1

Contraindications for Using the CRW System  The head ring is contraindicated for infants whose coronal sutures have not

yet closed.  The CRW system is contraindicated for patients with Creutzfeldt–Jakob dis-

ease.

Single Use Precautions Single use devices are used with the CRW stereotactic system. The following precautions should be taken: For single patient use only. The Disposable Head Ring Screws, Long and Short (DHRSS5, DHRSL5) are designed as single-use, disposable products and should not be re-sterilized or reused. Re-sterilization and reuse may result in dullness of the screw, leading to potential head ring movement, and cross contamination. Any Disposable Head Ring Screw, once used, should be discarded according to hospital policy. For single patient use only. The Apuzzo Stereotactic Drapes (ASD1 and ASD1B) are designed as single-use, disposable products and should not be re-sterilized or reused. Reuse of this device may result in cross contamination or compromised sterility of the drape and sterile field. Any drape, once used, should be discarded according to hospital policy. For single patient use only. The Nashhold Biopsy Needle (NBND) is designed as a single-use, disposable product and should not be re-sterilized or reused. Re-sterilization may result in impaired function (e.g. dulling of the cutting window, loss of vacuum) and cross contamination. Any needle, once used, should be discarded according to hospital policy. For single patient use only. The CRW BiopsyPlus Kit (CRWBP) is designed as a single-use, disposable product and should not be re-sterilized or reused. Re-sterilization may result in impaired function (e.g. dullness of cutting window, loss of vacuum, inaccuracy of bushing) and cross contamination. Once used, the kit should be discarded according to hospital policy.

2 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

Accuracy of the CRW System User error in the cursor placement and slice positioning contribute to the total application error. The accuracy in the lateral and AP dimension is  2 mm. Error in the vertical direction may be as large as the thickness of the scan slice (2 or 4 mm). The intrinsic mechanical accuracy of the arc is better than 0.5 mm, as determined in bench testing. To ensure proper accuracy and function of the CRW system, do not subject any of the CRW system’s parts or accessories to any forces that may affect its use or calibration. Always inspect the CRW system’s parts and accessories prior to use. If any of the parts or accessories are damaged in a way that may potentially affect the system’s accuracy or function, please return the system to Integra for service (see page 79 for packaging instructions). The CRW system should be viewed as adjuncts to the skills of the surgeon.

Using the CRW System with Electrosurgical Devices If the CRW system is to be used with a ground–referenced electrosurgical device (monopolar or bipolar electrode), the head ring should not contact the patient. Maintain a gap (at least 1/4 inch) between the head ring and the patient’s body. • Follow safety procedures consistent with the use of anesthetizing gases when using the arc system with electrosurgical equipment. • Review the system and its accessories prior to surgery to ensure that all items are available and functional.

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 3

List of Symbols The following symbols appear on the device labeling: Symbol

Definition Consult instructions for use.

Use by

Hand Wash only - Do not use automatic or power washing cycles; Hand wash to remove all debris and residue and thoroughly dry.

Lot number

Manufacturer

Authorized representative in the European community.

In this manual, this symbol “Warning/Caution” indicate conditions or practices that could lead to illness or injury or could damage the equipment or other property Non-sterile

Catalog number

Single use only

4 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

Symbol

SN

Definition Serial number

Sterilized using irradiation

Device is compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive.

Device is compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive.

Caution: Federal (USA) law restricts this device to sale by or on order of a physician or practioner. Sterilized using Ethylene Oxide

This product is not manufactured with Dry Natural Rubber or Natural Rubber Latex

Do not use if package is damaged

Contains or Presence of Phthalate

Date of manufacture

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 5

List of CRW System Components CRW Arc

System

Catalog #

CRW Precision Arc System

CRWPRECISE This system includes: • (1) CRW Precision Arc • (2) Operator’s Manual (CRWPMAN) • (1) Guide Block (CRWPGB) • (1) CRW Fixed Arc System Pointer (CRWFASP) • (1) 2.7mm x 76mm Guide Tube (GT2776) • (1) 2.7mm x 116mm Guide Tube (GT27116) • (1) 2.7mm Reducing Bushing (RB27) • (1) 1.9mm x 76mm Reducing Tube (RTNBND76) • (1) 1.9mm x 116mm Reducing Tube (RTNBND116) • (1) 2.7mm Drill Assembly (DA27) • (1) Keller Depth Gauge (KDG) • (1) Steel Ruler (SR) • (1) Sterilization Case Lid (CRWPLCASE) • (1) Sterilization Case Accessory Tray (CRWACCCASE) • (1) Sterilization Case Arc Component Tray (CRWARCCASE) To re-order any of the components from the above list, use the catalog numbers that appear after each respective CRW component.

6 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

System Accessories and Components Accessories and Components

Catalog #

Keller Depth Gauge

KDG

Guide Block

CRWASGB

Stainless Steel Ruler

SR

MAYFIELD® Adapters

CRWMA

CRWFMA

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 7

Accessories and Components

Catalog #

Guide Tubes

• GT27160: 2.7 mm I.D. x 160 mm working length • GT27116: 2.7 mm I.D. x 116 mm working length • GT2776:

2.7 mm I.D. x 76 mm working length

• GT32116: 3.2 mm I.D. x 116 mm working length • GT32160: 3.2 mm I.D. x 160 mm working length • GT3276:

3.2 mm I.D. x 76 mm working length

• GT46116: 4.6 mm I.D. x 116 mm total length

Reducing Bushings

• RB27: 2.7 mm I.D. • RB32: 3.2 mm I.D.

Reducing Tubes

Probe Holder (30 Degree Offset)

• RT11116:

1.1 mm I.D. x 116 mm length

• RT1176:

1.1 mm I.D. x 76 mm length

• RT16116:

1.6 mm I.D. x 116 mm length

• RT1676:

1.8 mm I.D. x 76 mm length

• RT1876:

1.8 mm I.D. x 76 mm length

• RT18116:

1.8 mm I.D. x 116 mm length

• RT20116:

2.0 mm I.D. x 116 mm length

• RT20160:

2.0 mm I.D. x 160 mm length

• RT21116:

2.1 mm I.D. x 116 mm length

• RT2176:

2.1 mm I.D. x 76 mm length

• RTNBND160:

NBND I.D. x 160 mm length

• RTNBND116:

NBND I.D. x 116 mm length

• RTNBND76 :

NBND I.D. x 76 mm length

CRWP30

8 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

Head Rings and Accessories Head Rings and Accessories

Catalog #

UCHRA (Universal Compact Head Ring)

UCHRA

UCHRAP (Adapter Plate)

UCHRAP

UCHRA Storage and Sterilization Case

UCHRCASE

UCHRA Hardware Kit

UCHRHK This kit includes: (4) Adapter plate attachment screws (2) Intubation hoop attachment screws (4) Head post attachment screws (2) Ear bar assembly attachment screws (2) Ear bar assembly nylon thumb screws

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 9

Head Rings and Accessories

Catalog #

UCHRP (Composite Post & Cross Bar Kit)

UCHRP

UCHREBA (Head Ring Ear Bar Kit)

UCHREBA

UCHREB (Individual Ear Bars for UCHREBA)

UCHREB

HRW (Head Ring Wrench)

HRW

HRAIM (Intubation Head Ring Assembly)

HRAIM

HRD (Head Ring Drive)

HRD

10 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

Head Rings and Accessories

Catalog #

Head Ring Sector

HRIMS

HRDXS (Head Ring Drive Extender / Shortener)

HRDXS

HRP (Head Ring Post)

HRP

TAP (Cleaning Tap for HRP and UCHRP)

TAP

HRKTP (Head Ring Positioner)

HRKTP

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 11

Head Rings and Accessories

Catalog #

Conical T-Bolt Screws

CSS

HREBA (Intubation Head Ring Ear Bar Kit)

HREBA

12 • Chapter 1 • About the CRW® Precision Arc Stereotactic System

Imaging Localizers Localizer

Catalog #

BRWLF (CT Localizer Frame)

BRWLF

Luminant® (MR/CT Localizer)

LL01

Quality Assurance Components QA Component

Catalog #

Phantom Base System

CRWPBS

CRW Arc System Pointer

CRWASP

Chapter 1 • About the CRW® Precision Arc Stereotactic System • 13

QA Component

Catalog #

CRW Fixed Arc System Pointer

CRWFASP

Phantom Base Sterile Pointer

RLPPSP

Phantom Base Hardware Kit

CRWPBSHK This system includes: • (2) Sphere hole thumb screws • (2) Thumb knobs (10-32 x 1/2”) • (1) LFLF T-Side sub-assembly • (2) AP / VERT locking screws • (1 each) Screw and cap (1/4”)

Reticles

• CRWTBSS (Lateral Reticles)

• CRWAPBS (Anterior / Posterior Reticles)

14 • Chapter 1 • About the CRW® Precision Arc Stereotactic System