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Brainlab CRANIAL/ENT OPTICAL User Manual

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CRANIAL/ENT
OPTICAL
Instrument User Guide
Revision 2.3
Copyright 2019, Brainlab AG Germany. All rights reserved.

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Summary of Contents for Brainlab CRANIAL/ENT OPTICAL

  • Page 1 CRANIAL/ENT OPTICAL Instrument User Guide Revision 2.3 Copyright 2019, Brainlab AG Germany. All rights reserved.

  • Page 3: Table Of Contents

    4.3.1 Softouch Pointer Technical Information ....................43 4.4 Z-touch Laser Pointer ........................45 4.4.1 Z-touch Laser Beams ........................47 4.4.2 Control LED and Laser Indications ....................49 4.4.3 Z-touch Laser Pointer Technical Information ..................52 4.5 Pointer Electromagnetic Information ...................54 5 REFERENCES .........................57 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 4 9.4 Attaching the Microscope Tracking Array (41767-19) to the Microscope Adapter ..113 9.4.2 Available Microscope Adapter Kits ....................114 9.5 Leica Microscopes .........................117 9.5.1 Connection to Curve 1.1 and Above....................118 9.5.2 Connection to Curve ceiling-mounted.....................119 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 5 .........................136 9.8.1 Connection to Curve 1.1 and Above....................138 9.8.2 Connection to Curve ceiling-mounted.....................140 9.8.3 Connection to Kick 1.0 and Kick 2.0 ....................141 9.8.4 Connection to Kolibri ........................142 9.8.5 Connection to VectorVision sky ......................143 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 6 TABLE OF CONTENTS Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 7: General Information

    Japan Fax: +81 3 3769 6901 Expected Service Life Unless specifically stated otherwise, Brainlab provides five years of service for instruments. During this period of time, spare parts as well as field support are offered. Feedback Despite careful review, this user guide may contain errors. Please contact us at user.guides@brainlab.com if you have improvement suggestions.

  • Page 8: Legal Information

    This product may be covered by one or more patents or pending patent applications. For details, see: www.brainlab.com/patent. CE Label The CE label shows that the Brainlab product complies with the essential re- quirements of Council Directive 93/42/EEC (the “MDD”). According to the rules established by the MDD, the classification of the Brain- lab product is defined in the corresponding Software User Guide.
  • Page 9 GENERAL INFORMATION You are required to report any serious incident that may have occurred related to this product to Brainlab, and if within Europe, to your corresponding national competent authority for medical devices. Sales in US US federal law restricts this device to sale by or on the order of a physician.

  • Page 10: Symbols

    Non-sterile NOTE: Indicates a medical device that has not been subjected to a sterilization proc- ess. Do not resterilize NOTE: Indicates a medical device that should not be resterilized. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 11 Use by date NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD. Date of manufacture NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD. Manufacturer Authorized representative in the European Community Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 12 Non-pyrogenic Indicates that the equipment is suitable for direct current only Sitting prohibited Keep hands clear (pinch point hazard) Contains an RF transmitter for operation Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 13 GENERAL INFORMATION Symbol Explanation Class II Equipment Unique Device Identifier Refer to instruction manual or booklet Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 14: Using The System

    Using the System Using the System Intended Purpose This Instrument User Guide is intended for use with Brainlab Cranial Registration, Navigation and ENT software and contains information on how to assemble and safely use the required instruments in surgery. Careful Handling of Hardware System components and accessory instrumentation are comprised of precise mechanical parts.

  • Page 15: Training And Documentation

    • Read this guide carefully before handling the equipment • Have access to this guide at all times Available User Guides NOTE: Available user guides vary depending upon the Brainlab product. If you have questions regarding the user guides you received, please contact Brainlab support. User Guide Contents •...
  • Page 16 Training and Documentation Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 17: Instrumentation Overview

    Brainlab service provider for instructions on how to proceed. Failure to do so and continued use of a damaged device may lead to serious injury to the patient.
  • Page 18 For the best recognition of the array, position the array perpendicular to the plane through the centers of all marker spheres. Possible Complications Use of some Brainlab products requires an additional incision to be made. Therefore, the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, bone fracture or thrombosis.

  • Page 19: Available Instruments

    NOTE: Not detailed in this user guide. See separate in- structional leaflet for further information. VarioGuide Drill Kit NOTE: Not detailed in this user guide. See separate in- structional leaflet for further information. Suction Tubes Instrument Calibration Matrix Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 20 Softouch Pointer Z- touch Laser Pointer References Illustration Name Standard Cranial Reference Array (3- and 4-Marker) Reference Clamp Universal Vario Reference Arm Reference Headband and Reference Unit For Head- band Skull Reference Package Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 21 INSTRUMENTATION OVERVIEW Instrument Adapters Illustration Name Instrument Adapter Package Instrument Adapter Clamps for Rectangular/Cylin- drical Instruments Ultrasound Illustration Name Ultrasound Adapters Ultrasound Registration Phantom Biopsy Instrument Holders Illustration Name Frameless Biopsy System VarioGuide Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 22 Available Instruments Microscope Adapters Illustration Name Microscope Tracking Arrays and Adapter Sets Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 23: General Instrumentation

    Warning Brainlab navigation systems can only be used with the above marker spheres. The use of other marker spheres could affect navigation accuracy, posing a risk to the patient.

  • Page 24: Using Marker Spheres

    Ensure that marker spheres are screwed onto the pin until there is no gap between the sphere and the base of the pin. Do not use a marker sphere if it is not securely attached in this position. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 25 Warning If you use marker spheres on, or in the vicinity of, oscillating or vibrating instruments, check the marker spheres at regular intervals to ensure that they remain securely attached. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 26: Disposable Registration Markers

    NOTE: Store the kit within easy reach of the CT scanner. NOTE: Store the CT markers in a cool, dry place, away from direct sunlight. Storage temperature should not exceed 21 °C. Registration Marker OR (52152) Figure 4 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 27 CT, MRI, and other imaging sources. Correct Handling Warning Multi-Modality Donut Registration Markers are disposable and must be disposed of after use. NOTE: Do not use Multi-Modality Donut Registration Markers that are visibly damaged. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 28: Attaching Markers

    • To avoid ambiguities, place the marker plates asymmetrical to the midsagittal plane Warning Make sure that the position of the registration markers does not change (e.g., due to fixation of devices during scanning, swellings of the anatomy, or intubation). Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 29 After registration, remove and dispose of OR marker sockets and marker plates. Warning Once marker plates have been removed, fiducial registration is no longer possible. Do not attempt to re-attach marker plates unless they have been clearly marked using permanent marker. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 30 After Scanning is Complete Step Import scan images to a Brainlab planning station (see relevant Software User Guide). • Use scan images to create a treatment plan (see relevant Software User Guide). • Alternatively, import scan images directly into Patient Data Manager and send to a naviga- tion system in order to plan markers with navigation software (see relevant Software User Guide).

  • Page 31: Suction Tubes

    GENERAL INSTRUMENTATION Suction Tubes Introduction Brainlab suction tubes (55790, 55790-XX) are available in different sizes and with two different tips. Specifications ① ② ③ Figure 9 Suction Angle Available Tips Article No. Tube Size Type Right-Handed Left-Handed Pear tip 55790-25...

  • Page 32: Instrument Calibration Matrix

    • Shaft diameter of instruments calibrated in the V-inset Calibrate the long axis of: • Short shafts ⑤ Receptacle (example) • Shafts that do not reach reference plane 4 (when the in- strument is positioned in the V-inset) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 33 GENERAL INSTRUMENTATION No. Component Function Calibrate: ⑥ Pivot points • Pointed instruments Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 34 Instrument Calibration Matrix Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 35: Pointers

    If the pointer is undamaged, the tip aligns with the corresponding counter pin on the pointer gauge. Warning The accuracy of the pointer has to be checked using the pointer gauge before use. Always store the pointer in the appropriate gauge. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 36 Warning Handle the pointer with extreme care. Should the pointer tip become bent or deformed in any way, report this to Brainlab support. Working with a damaged pointer tip will lead to extreme inaccuracy during navigation. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 37: Multiple Tip Pointer Package

    NOTE: Only use the paint pointer tips with the Handle for Multiple Tip Pointer. No. Component Length Article No. ① Eraser Pointer Tip (Curved) 55791-06 130 mm ② Tip Set for Paint Pointer 41783 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 38 NOTE: Exchanging the pointer tip or the instrument tracking array requires a new calibration. NOTE: The tip, and not the shaft of the Multiple Tip Pointer is used for calibration of the instrument’s trajectory. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 39: Softouch Pointer

    Standby ① • Turn on: press the switch for less than one second switch • Turn off: press the switch for two seconds NOTE: The Softouch Pointer turns off automatically after two minutes. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 40 Do not sterilize Softouch. Sterilization will destroy the device and might lead to severe damage of the sterilization equipment or injury to the patient or user. Softouch may be used for unsterile procedures only. For cleaning and disinfection instructions, see the Cleaning, Disinfection, and Sterilization Guide. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 41 Warning Handle the pointer with extreme care. Should the pointer tip become bent or deformed in any way, report this to Brainlab support. Working with a damaged pointer tip will lead to extreme inaccuracy during navigation. Do not expose Softouch to excessive UV light such as direct sunlight, as this might affect its plastic exterior.
  • Page 42 Lithium batteries must be compliant with IEC 60086-4. NOTE: The only service available for Softouch is the replacement of the battery. Dispose of the pointer and/or the battery separately, according to your organization’s rules and local legislation. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 43: Softouch Pointer Technical Information

    Modification of the device is not allowed. Battery Safety Warning Do not use Softouch if it is leaking battery acid. In case of failure, contact Brainlab Support. Remove the battery when the pointer is not used over more than six months to prevent the battery from leaking.
  • Page 44 Wavelength: λ = 630 nm Certifications and Classifications Certification IEC 60601-1 Classifications According to Internally Powered ME Equipment for Continuous Operations IEC 60601-1 IP44 IEC 60529 Exempt group: LEDs do not pose any photobiological hazards Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 45: Z-Touch Laser Pointer

    Correct Instrument Handling Warning Handle the pointer with extreme care. Should the pointer tip become bent or deformed in any way, report this to Brainlab support. Working with a damaged pointer tip will lead to extreme inaccuracy during navigation. Warning Do not expose infrared detectors from other devices to the Z-touch laser beam or Brainlab camera.
  • Page 46 Z-touch Laser Pointer Z-touch is not waterproof. Do not spill any liquids onto Z-touch or immerse Z-touch in any liquids. Ensure that Z-touch does not come in direct contact with the patient. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 47: Z-Touch Laser Beams

    Before beginning registration, you must close the patient’s eyes. Do not point laser beam into the eyes of a narcotized patient. When used in combination with a Brainlab navigation system, Z-touch is a Class 3R laser device according to IEC 60825-1:2014. This should be communicated to your laser safety officer.
  • Page 48 Z-touch Laser Beams presence of a Brainlab navigation system is below the limits of Class 1 according to IEC 60825-1:2014). Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 49: Control Led And Laser Indications

    LED is solid yellow when the activation button is pressed. Solid yellow NOTE: If an error is detected, contact Brainlab immediately for advice on how to proceed. • Z-touch not activated (i.e., button not pressed).
  • Page 50 Correct Battery Use Remove battery from battery case if Z-touch will not be used for more than 6 months. Only use 1.5 V, Lithium Li/FeS2, FR03, size AAA batteries. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 51 POINTERS Battery Cover Only open battery cover when necessary. Do not try to open other parts of housing. Independent laser beams are routed inside housing. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 52: Z-Touch Laser Pointer Technical Information

    Length 22.2 cm Width 3.8 cm Weight 160 g Material PC/ABS blend (polycarbonate/acrylonitrile butadiene styrene) Electrical Specifications Specification Description Power Supply 1.5 V, Lithium Li/FeS2, FR03, Size AAA Power Consumption max. 130 mW Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 53 Complies with 21 CFR 1040.10 and 1040.11 NOTE: Except for deviations in accordance to Laser Notice No. 50, dated June 24, 2007 Internally Powered ME Equipment for Continuous Operation IEC 60601-1 IP44 IEC 60529 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 54: Pointer Electromagnetic Information

    If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation Softouch or Z-touch. Over the 150 kHz to 80 MHz frequency range, field strengths should be less than [V1] V/m. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 55 For transmitters rated at a maximum output power not listed above, d can be determined using the provided equations. P = maximum output power rating of the transmitter in watts (W) d = recommended separation distance in metres (m) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 56 Pointer Electromagnetic Information Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 57: References

    Compatibility Name Compatibility Article • Reference Clamp Uni- Standard Cranial Reference Array with 3 Marker versal 41735 Spheres (1 Piece) • Vario Reference Arm Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 58 Standard Cranial Reference Array with 4 Marker 41725 Spheres (1 Piece) Reference Array Version B (41735B) Figure 22 Warning Only use Version B arrays together with other Version B arrays. NOTE: Expiration information is lasered into the reference array. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 59: Positioning Arrays

    Do not move a reference array relative to the patient’s anatomy during the procedure. Changing the array’s position throws off the entire measurement coordinate system, endangering the patient. Warning To avoid unintentional movement of the reference array, do not place pressure on it. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 60 Positioning Arrays Warning If the position of the reference array changes relative to the patient, a new registration is required. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 61: Reference Clamp Universal

    To maintain adequate resistance in the reference arm joints, do not lubricate the joints. Warning Keep both the central tension handle and Mayfield "T" Screw tightened to avoid any movement of the Reference Clamp Universal and reference array during registration and navigation. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 62 Adjust the array to the required position and secure it in this position, by tightening the handles ③. NOTE: To remove the unsterile array, loosen the handles, open the fixation nut and lift the array off. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 63 Do not unscrew any Reference Clamp Universal screws after registration. Only the fixation nut can be unscrewed to exchange the Standard Cranial Reference Array. Only use identical reference arrays in combination with the Reference Clamp Universal. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 64: Vario Reference Arm For Mayfield Headholder

    Adjust the arm ① to the desired position and securely re-tighten the handle by turning it counterclockwise. Loosening the Arm Warning Never loosen the central tension handle without gripping the articulated arm with your other hand. The Vario Reference Arm could fall on the patient. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 65: Attaching Arm To Headholder

    Central tension handle ④ Reference array connector ⑤ Articulated arm ⑥ Headholder connector NOTE: All parts of the Vario Reference Arm for Mayfield Headholder can be adjusted by hand. No additional tools are required. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 66 Reference Arm for Mayfield Headholder with too much weight (i.e., do not lean on it, or place instrumentation on it). NOTE: Keep the central tension screw tightened during registration and navigation to protect the inner mechanism from liquids. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 67 Plan your OR setup prior to surgery. The camera must have an unobstructed view of the reflective marker spheres and infrared LEDs on Softouch. NOTE: Position the array so that it is out of the surgeon’s way, close to the planned craniotomy and visible to the camera. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 68: Reference Headband

    Orient the Reference Unit for Headband so that the arrow ② points upwards. Remove the foil from the foam pad and stick the foam pad onto the patient’s forehead, positioning the reference connector ① towards the camera. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 69 (e.g., on the forehead), due to fixation pressure. These indentations generally disappear within 24 hours. Do not cover the skin the Z-touch or Softouch need for registration with the headband or drape. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 70: Skull Reference Package

    Disposable KLS Martin Bone Fixation Screw 1.5 mm x 6 Must be sterilized 52170 mm (5 PCS) NOTE: If only one reference array is used, all instruments and procedures must be applied in a sterile environment. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 71: Screwdriver

    Pull back the front sleeve ② of the handle ③. Insert the screwdriver blade ① into the handle and release the sleeve. Only use implantable screws and screwdrivers approved by Brainlab to attach the Skull Reference Package. Otherwise, this could affect navigation accuracy, posing a risk to the patient.

  • Page 72: Assembly And Attachment

    The surgeon must be aware that essential structures could be injured during placement. Warning Only use the screws and screwdriver approved by Brainlab. Using other screws can result in severe patient injury and inaccurate navigation. For patients with a high bone density, predrilling could facilitate screwing and avoid screw breakage.
  • Page 73 NOTE: If the tube you are using has a window, loosen the screw about half a turn coun- terclockwise. This facilitates easier removal of the device at the end of the procedure. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 74 Securely tighten both ① and ④ before starting registration. NOTE: Do not unscrew any of the reference screws after patient registration. Only the array cap nut may be unscrewed, to exchange the reference array. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 75 Following registration, unscrew and remove the unsterile reference array. Drape the patient as usual and make a slit in the drape to expose the connector interface ①. A sterile assistant or nurse should then attach the sterile array to the interface. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 76: Removing The Skull Reference Package

    Standard Procedure ① Figure 37 Step Unscrew and remove the Skull Reference Array. Loosen the tube cap nut ①. Remove the screw with the screwdriver. Remove the Reference Base Skull by pulling it upwards. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 77 If the screw is not visible, carefully unclip and remove the tube. Unscrew and remove the screw with the screwdriver. NOTE: If the screw was loosened a half turn during installation, slide the tube laterally to disengage it from the screw and lift it away. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 78 Removing the Skull Reference Package Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 79: Instrument Adapters

    Components ① ② ③ No. Name Article No. Instrument Adapter Clamp Size S 55101 Instrument Adapter Clamp Size M 55102 ① Instrument Adapter Clamp Size L 55103 Instrument Adapter Clamp Size XL 55104 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 80 Insert the array stem ② into the clamp ① and align the teeth on both components. Tighten the screw knob ③ by hand or by using the Tool for Instrument Adapter, ensur- ing that the array is securely attached to the clamp. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 81 Attach the array so that the longest arm of the array is in line with the instrument axis. Tighten the fix knob ② by hand, to secure the instrument adapter clamp. NOTE: Use the Tool for Instrument Adapter, if needed. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 82: Instrument Adapter Accessory

    Fit the Instrument Adapter Offset-Link 45° 20 mm base ② onto an Instrument Adapt- er Clamp ① and align the teeth on both components. Tighten the offset-link screw ③ to secure the it onto the adapter clamp. Attach the array ④ to the offset-link. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 83: Instrument Adapter Clamps For Rectangular/Cylindrical Instruments

    For rectangular instruments, attach the adapter ① to the rear handle of the forceps. For cylindrical instruments, insert the cylindrical instrument into the adapter ②. Make sure that the clamp notch matches the instrument handle. Attach the relevant Instrument Adapter Array to the adapter. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 84 Ensure that all instrument adapter screws are securely tightened before calibration. If you exchange the tracking array for one of a different size, recalibrate and verify the instrument before continuing. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 85: Ultrasound

    Ultrasound Adapters General Information Ultrasound Adapters allow you to adapt the ultrasound probes to be compatible with Brainlab navigation software and systems. The adapters are available with various lock mechanisms to fit specified probes. Depending on your probe, standard fit or unique fit adapters are available.

  • Page 86: Components

    41860-2 Ultrasound Clamp B&K 8562 41860-20 Ultrasound Clamp Siemens 5.0/7.5 Microsector 41860-21 Ultrasound Clamp GE 10S Sectortransducer 41860-24 Ultrasound Adapter Siemens Sonoline C8-5 41860-25 Ultrasound Adapter VF13.5SP Siemens 41860-27A Ultrasound Adapter Toshiba PSF65AT Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 87 41860-36 Ultrasound Adapter Base Aloka UST-9133 41860-38 Ultrasound Adapter GE 8C-RS 41860-39 Ultrasound Adapter Acuson P10-4 41860-41 Ultrasound Adapter Sonosite HFL38X 41860-5D Adapter Base For UST 987/9104/9120 (Aloka) 41860-9 Ultrasound Clamp B&K 8547 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 88: Attaching The Unique Fit Adapter Base To The Probe

    Make sure that the adapter is tightly attached and fits securely to the edge of the probe ③ Secure the adapter by hooking the buckle over the notch, making sure to lock the catch ④. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 89 To continue navigation, a new sterile drape and a new sterile adapter array must be used. NOTE: If the drape between the adapter base and the adapter array is wrinkled, smooth it by hand before mounting the tracking array. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 90: Attaching The Standard Fit Adapter To The Probe

    How to Attach Adapters with a Clamp Lock ① ② Figure 49 Step Place the Ultrasound Adapter onto the ultrasound probe. Tighten the screw ① until the clamp ② fits securely onto the probe. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 91 Tighten the screw ① until the tong ② fits securely onto the probe. How to Attach Adapters with a Vise Lock ① Figure 51 Step Place the ultrasound adapters onto the ultrasound probe. Tighten the screw ① until the vise fits securely on the probe. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 92 How to Attach Adapters with a Ring Lock ① ② Figure 52 Step Place the Ultrasound Adapter onto the ultrasound probe. Tighten the screw ① until the ring ② fits securely onto the probe. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 93: Ultrasound Calibration

    (e.g., if navigation is performed with a draped probe, calibration should also take place with the drape). If the probe is sterilizable and the calibration is done without a drape, then no drape should be used during navigation. Otherwise recalibration is recommended. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 94: Draping Ultrasound Adapters

    Ultrasound Adapter Base ② at least four times with different drape ④ posi- tions. Repeat this procedure with a second drape and perform step 2 with both prepared drapes, one on top of the other. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 95 Disregard leakage within 40 mm of the cuff end. Repeat steps 1 and 2 with a second drape. The test is passed if no leakage is observed. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 96 Draping Ultrasound Adapters Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 97: Biopsy Instrument Holders

    Vario- 52005 Guide. V-inset for GE Head Holder 52006 ⑥ Biopsy Alignment Array 55972 Navigate: • Precalibrated instruments ⑦ Biopsy Tube 55970 • Other cylindrical instruments that are not pre-calibrated Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 98 Do not rotate the instrument during removal as this movement could inadvertently loosen the biopsy tube inserts. Do not confuse the guide and biopsy tube screws during surgery as unscrewing the wrong screw could cause the biopsy tube to fall onto the patient. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 99 Place the T-screw directly onto the skull clamp, V-inset, or interface, thereby puncturing the drape ⑧. Close the screw tightly, ensuring that the teeth of both components are properly inter- locked ⑨. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 100 Do not grip the Frameless Biopsy System at the ball joints while the central tension handle is unfastened as you could injure your fingers. Warning To maintain adequate friction, do not lubricate the joints. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 101 During instrument insertion the instrument should slide easily and firmly into the sleeve without resistance or any looseness. Transporting the Frameless Biopsy System Transport the Frameless Biopsy System carefully to avoid damaging the device. Store the Frameless Biopsy System in an appropriate sterilization tray. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 102: Varioguide

    VarioGuide Joint 2 (includes the array holder and telescope) 55950-50 • V-inset for GE Head Holder • 52006 ④ • V-inset for IMRIS Head Holder • 52005 • V-inset for Mayfield Head Holder • 52003 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 103 • Head Coil Set Philips 1.5T • 111921 • Head Coil Set Philips 3.0T • 114557 MR Rating Warning The VarioGuide is MR-conditional for operation outside the 5 Gauss (0.5 mTesla) line only. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 104: Assembly

    Warning Do not grip the VarioGuide around the ball joints while the arm is moved as you could injure your hands or fingers. Warning To maintain adequate friction, do not lubricate the joints. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 105 Guide Disc). In case of using a drill guide tube, choose an appropriate sleeve diameter for guiding the instrument. Warning Inspect the Guide Disc for damages before each use. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 106 Align the line on the assembled outer discs with the line on the inner disk and screw the rings together on the array holder ③. Warning Always hold the guide disc while taking it out of the VarioGuide. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 107: Attaching The Varioguide To The Skull Clamp

    Skull Clamp for Biopsy Arm/Varioguide (19223-03) to the skull clamp interface. NOTE: Also attach the Radiolucent Adapter for DORO Skull Clamp. Place the “T” screw directly onto the skull clamp, V-inset, or interface, thereby puncturing the drape ①. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 108 Position the VarioGuide as required, securing it tightly with the central tension handle ①. Place additional drapes around the biopsy system and the reference array. Warning Always support the arm with one hand while operating the central tension handle. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 109: Microscopes

    Microscope Adapter Sets General Information Microscopes from various manufacturers can be set up for use with Brainlab navigation systems. The navigation system is able to acquire the viewing direction, the focus point, and the field of view diameter of the microscope and display the information on the navigation screen.
  • Page 110 A Microscope Adapter Set consists of: • A microscope adapter • A Microscope Tracking Array Brainlab support will mount the specific microscope adapter to the microscope case. The microscope adapter is permanently attached to the microscope case and should not be removed. Warning Do not loosen the attachment screws between the microscope adapter and the optical head.

  • Page 111: Draping

    NOTE: For more information, refer to the Cranial/ENT Instrument User Guide. Warning Ensure that the marker spheres can be screwed onto the pin until there is no gap between the marker sphere and the base of the pin. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 112: Strain Relief

    Attach the microscope cable with the Velcro strap ②: • To the rail of the ceiling unit, when using the Curve Ceiling-Mounted system (top pho- • To the strain relief adapter, when using the Curve ③ and Kick systems ④. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 113: Attaching The Microscope Tracking Array (41767-19) To The Microscope Adapter

    NOTE: You can attach the microscope tracking array either in the standard or 90° position, depending on the individual OR setup. NOTE: Make sure that the microscope tracking array is securely attached to the microscope adapter prior to each treatment. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 114: Available Microscope Adapter Kits

    • In the standard orientation ① • At a 90° angle ② Leica M500-N, M520, M525, M530, M720 (SAI) (41767-70) ② ① Figure 69 Haag-Streit Hi-R 1000/Hi-R 700 (41767-85) ① ② Figure 70 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 115 Olympus OME-8000 (41767-10) ① ② Figure 72 Olympus OME-9000 (41767-18) ① ② ③ Figure 73 The Olympus OME-9000 has three mounting orientations: • Standard right ① • Standard left ② ③ ° • 90 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 116 Zeiss OPMI Neuro (41767-60) ① ② Figure 74 Zeiss OPMI Pentero, OPMI PENTERO 800, OPMI PENTERO 900, KINEVO 900, OPMI VARIO 700 (41767-55) ① ② Figure 75 Zeiss OPMI Vario (41767-30) ① ② Figure 76 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 117: Leica Microscopes

    This strap fits through the hole located on the foot of the system. Leica M500-N/M520 Figure 77 Leica M525/M530/M720 (SAI) Figure 78 NOTE: It is recommended to use an HD-SDI connection if available. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 118: Connection To Curve 1.1 And Above

    This strap fits through the hole located on the foot of the system. Leica M500-N/M520 Figure 79 Leica M525/M530/M720 (SAI) Figure 80 NOTE: It is recommended to use an HD-SDI connection if available. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 119: Connection To Curve Ceiling-Mounted

    NOTE: Secure the loose cables that hang from the Curve ceiling-mounted Connection Unit to the rail of the ceiling supply unit (CSU) with the Velcro strap. Leica M500-N/M520 Figure 81 Leica M525/M530/M720 (SAI) Figure 82 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 120: Connection To Kick 1.0 And Kick 2.0

    NOTE: Secure the loose cables that hang from Kick to the base of the system with the Velcro strap provided. This strap fits through the hole located on the foot of the system. Leica M500-N/M520 Figure 83 Leica M525/M530/M720 (SAI) Figure 84 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 121: Connection To Kolibri

    Kolibri system according to the following diagrams. Leica M500-N/M520 ① Figure 85 Component ① Kolibri 2.0 CAN-BUS adapter cable (19514-03) Leica M525/M720 (SAI) ① Figure 86 Component ① Kolibri 2.0 CAN-BUS adapter cable (19514-03) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 122: Connection To Vectorvision Sky

    How to Connect Connect the supplied cables between the microscope ports and the corresponding ports on the VectorVision sky system according to the following diagrams. Leica M500-N/M520 Figure 87 Leica M525/M720 (SAI) Figure 88 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 123: Haag-Streit Microscopes

    Velcro straps provided. This strap fits through the hole located on the foot of the system. Haag-Streit Hi-R 1000/Hi-R 700 Figure 89 NOTE: Image injection is not available for Haag-Streit Hi-R 700. NOTE: It is recommended to use an HD-SDI connection if available. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 124: Connection To Curve 1.1 And Above

    NOTE: HUD is not available for Haag-Streit Hi-R 700. NOTE: It is recommended to use an HD-SDI connection if available. Haag-Streit Hi-R 1000 Figure 91 NOTE: It is recommended to use an HD-SDI connection if available. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 125: Connection To Curve Ceiling-Mounted

    NOTE: Secure the loose cables that hang from the Curve ceiling-mounted Connection Unit to the rail of the ceiling supply unit (CSU) with the Velcro strap. Haag-Streit Hi-R 1000/Hi-R 700 Figure 92 NOTE: Image injection is not available for Haag-Streit Hi-R 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 126: Connection To Kick 1.0 And Kick 2.0

    NOTE: Secure the loose cables that hang from Kick to the base of the system with the Velcro strap provided. This strap fits through the hole located on the foot of the system. Haag-Streit Hi-R 1000/Hi-R 700 Figure 93 NOTE: Image injection is not available for Haag-Streit Hi-R 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 127: Connection To Kolibri

    Connect the supplied cables between the microscope ports and the corresponding ports on the Kolibri system according to the following diagrams. Haag-Streit Hi-R 1000/Hi-R 700 Figure 94 NOTE: Image injection is not available for Haag-Streit Hi-R 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 128: Connection To Vectorvision Sky

    Connect the supplied cables between the microscope ports and the corresponding ports on the VectorVision sky system according to the following diagrams. Haag-Streit Hi-R 1000/Hi-R 700 Figure 95 NOTE: Image injection is not available for Haag-Streit Hi-R 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 129: Olympus Microscopes

    Velcro straps provided. This strap fits through the hole located on the foot of the system. Olympus OME-7000/8000 ③ ④ ② ① Figure 96 Component ① VGA, 5x BNC cable ② RS 232 microscope cable ③ BNC video cable ④ 9 pole gender changer (female-female) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 130 Olympus Microscopes Olympus OME-9000 ③ ④ ② ① Figure 97 Component ① SVGA cable ② RS 232 microscope cable ③ BNC video cable ④ 9 pole gender changer (female-female) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 131: Connection To Curve 1.1 And Above

    NOTE: Secure the loose cables that hang from Curve to the base of the system with the Velcro strap provided. This strap fits through the hole located on the foot of the system. Olympus OME-7000/8000/9000 ① Figure 98 Component ① Gender changer DB9 FA440-R2 (plug-plug) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 132: Connection To Curve Ceiling-Mounted

    NOTE: Secure the loose cables that hang from the Curve ceiling-mounted Connection Unit to the rail of the ceiling supply unit (CSU) with the Velcro strap. Olympus OME-7000/8000/9000 ① Figure 99 Component ① Gender changer DB9 FA440-R2 (plug-plug) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 133: Connection To Kick 1.0 And Kick 2.0

    NOTE: Secure the loose cables that hang from Kick to the base of the system with the Velcro strap provided. This strap fits through the hole located on the foot of the system. Olympus OME-7000/8000/9000 ① Figure 100 Component ① Gender changer DB9 FA440-R2 (plug-plug) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 134: Connection To Kolibri

    Connect the supplied cables between the microscope ports and the corresponding ports on the Kolibri system according to the following diagrams. Olympus OME-7000/8000 ① Figure 101 Component ① 9 pole gender changer (female-female) Olympus OME-9000 ① Figure 102 Component ① 9 pole gender changer (female-female) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 135: Connection To Vectorvision Sky

    Connect the supplied cables between the microscope ports and the corresponding ports on the VectorVision sky system according to the following diagrams. Olympus OME-7000/8000 ① Figure 103 Component ① 9 pole gender changer (female-female) Olympus OME-9000 ① Figure 104 Component ① 9 pole gender changer (female-female) Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 136: Zeiss Microscopes

    Zeiss OPMI Pentero/Pentero C/PENTERO 800/PENTERO 900/VARIO 700, KINEVO 900 (Legacy ODU Interface) Figure 106 NOTE: Image injection is not available for OPMI VARIO 700. NOTE: It is recommended to use an HD-SDI connection if available. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 137 MICROSCOPES Zeiss OPMI Vario Figure 107 NOTE: Image injection is not available for OPMI Vario. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 138: Connection To Curve 1.1 And Above

    Zeiss OPMI Neuro MultiVision/Pentero Figure 108 Zeiss OPMI Pentero 900 Figure 109 Zeiss OPMI Vario/VARIO 700 (SD) Figure 110 NOTE: Image injection is not available for OPMI Vario and OPMI VARIO 700 (SD). Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 139 MICROSCOPES Zeiss OPMI VARIO 700 (HD) Figure 111 NOTE: Image injection is not available for OPMI VARIO 700 (HD). Zeiss KINEVO 900 (Advanced LAN Interface) Figure 112 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 140: Connection To Curve Ceiling-Mounted

    NOTE: Image injection is not available for OPMI Vario and VARIO 700 (SD). Zeiss OPMI Pentero/PENTERO 800/PENTERO 900/VARIO 700 (HD), KINEVO 900 (Legacy ODU Interface) Figure 114 NOTE: Image injection is not available for OPMI VARIO 700 (HD). Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 141: Connection To Kick 1.0 And Kick 2.0

    NOTE: Image injection is not available for OPMI Vario and VARIO 700. Zeiss OPMI PENTERO 800/PENTERO 900/VARIO 700 (HD) ① ② Figure 116 Component ① Adapter cable SVHS to 2BNC ② FGA 2B-4St/S-VHS-St 10m NOTE: Image injection is not available for OPMI VARIO 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 142: Connection To Kolibri

    Zeiss OPMI Pentero/Pentero C/PENTERO 800/PENTERO 900/VARIO 700 Figure 118 NOTE: Image injection is not available for OPMI VARIO 700. Zeiss OPMI Vario Figure 119 NOTE: Image injection is not available for OPMI Vario. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...

  • Page 143: Connection To Vectorvision Sky

    Zeiss OPMI Pentero/Pentero C/PENTERO 800/PENTERO 900/VARIO 700 ① Figure 121 Component ① Brainlab adapter cable CBLSVHS F> 2xBNC M 0.2M UL EXTRON26-541-0 (19190-73) NOTE: Image injection is not available for OPMI VARIO 700. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 144 Connection to VectorVision sky Zeiss OPMI Vario Figure 122 NOTE: Image injection is not available for OPMI Vario. Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 145 Haag-Streit, connection to navigation system...... 123 Leica, connection to navigation system........ 117 Olympus, connection to navigation system......129 Zeiss, connection to navigation system........136 multi-modality donut registration markers........27 pointer multiple tip................37 reference arrays positioning................59 Instrument User Guide Rev. 2.3 Cranial/ENT Optical...
  • Page 148 Art-No. 60919-29EN *60919-29EN*...

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