1. Manuals
  2. Brands
  3. Brainlab Manuals
  4. Medical Equipment
  5. CRANIAL/ENT OPTICAL TRACKING
  6. Instrument user manual

Brainlab CRANIAL/ENT OPTICAL TRACKING Instrument User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

CRANIAL/ENT
OPTICAL
TRACKING
Instrument User Guide
Revision 2.6
Date of issue: 2022-01-13 (ISO 8601)
Copyright 2022, Brainlab AG Germany. All rights reserved.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CRANIAL/ENT OPTICAL TRACKING and is the answer not in the manual?

Questions and answers

Related Manuals for Brainlab CRANIAL/ENT OPTICAL TRACKING

Summary of Contents for Brainlab CRANIAL/ENT OPTICAL TRACKING

  • Page 1 CRANIAL/ENT OPTICAL TRACKING Instrument User Guide Revision 2.6 Date of issue: 2022-01-13 (ISO 8601) Copyright 2022, Brainlab AG Germany. All rights reserved.

  • Page 3: Table Of Contents

    4.4.1 Z-touch Laser Beams ........................41 4.4.2 Control LED and Laser Indications ....................43 4.4.3 Z-touch Laser Pointer Technical Information ..................46 4.5 Electromagnetic Compatibility ......................49 5 REFERENCES .........................53 5.1 Standard Cranial Reference Array ....................53 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 4 8.1.2 Attaching the VarioGuide to the Head Holder .................100 9 MICROSCOPES ........................103 9.1 Microscope Adapter Sets ......................103 9.2 Draping .............................105 9.3 Attaching the Microscope Tracking Array (41767-19) to the Microscope Adapter ..106 9.3.2 Available Microscope Adapter Kits ....................107 INDEX ..............................109 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 5: General Information

    Fax: +81 3 3769 6901 Expected Product Lifetime Unless specifically stated otherwise, Brainlab provides five years of service for instruments. See the information about each instrument in this guide for more details. During the expected product lifetime, spare parts as well as field support are offered.

  • Page 6: Legal Information

    Report Incidents Related to This Product 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 7: 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 8 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 9 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 10 Symbols Symbol Explanation Class II Equipment Unique Device Identifier Single sterile barrier system with protective packaging inside Double sterile barrier system Follow instructions for use Medical Device Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 11: Using The System

    Using the System Purpose of this User Guide This Instrument User Guide is intended for use with Brainlab IGS Cranial 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 12: 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 13: 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 14 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 15 INSTRUMENTATION OVERVIEW • Navigation Pointer Cranial/ENT (41780-5) Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 16: Available Instruments And Classification

    NOTE: Visually inspect for breaches in the sterile barrier system integrity prior use. Reusable Suction Tubes Instrument Calibration Matrix Pointers Illustration Name Cranial Pointer Cranial/ENT with Blunt Tip Multiple Tip Pointer Package Softouch Pointer Z- touch Laser Pointer Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 17 NOTE: Instrument Adapter Array (Starlink), Size M only to be used for ENT. Instrument Adapter Clamps for Rectangular/ Cylindrical Instruments Instrument Adapter Offset-link 45° 20 mm Instrument Adapter Extension 50 mm Ultrasound Illustration Name Cranial Ultrasound Adapters Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 18 Available Instruments and Classification Illustration Name Cranial Ultrasound Registration Phantom Trajectory Alignment Tools Illustration Name Cranial VarioGuide V-Insets Microscope Adapters Illustration Name Cranial Microscope Tracking Array and Adapter Sets Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 19 Drill bit and handle 1.1 mm (optional) PAJUNK GmbH Karl-Hall-Strasse 1 Disposable Biopsy Needle Type A 78187 Geisingen Germany IZI Medical Products Multi-Modality Do- 7020 Tudsbury Road nut Registration Baltimore, MD 21244 Markers Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 20 Available Instruments and Classification Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 21: 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 22: 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 23 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 24: Suction Tubes

    Suction Tubes General Information Figure 3 The Brainlab reusable and disposable suction tubes are optically tracked surgical suction devices for use in Brainlab navigated surgical ENT (reusable suctions) or cranial (disposable suctions) procedures. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 25: Reusable Suction Tubes

    GENERAL INSTRUMENTATION 3.2.1 Reusable Suction Tubes General Information Brainlab suction tubes (55790, 55790-XX) are available in different sizes and with two different tips. Specifications ① ② ③ Figure 4 Suction Tube Angle Available Tips Article No. Size Type Right- Left-...
  • Page 26 Reusable Suction Tube Size Offset when Verification in 4- Calibration Method Marker Reference Array Cone 8 Charr. (REF 55790-75) 1.0 mm Receptacle 10 Charr. (REF 55790-70) 1.2 mm Receptacle Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 27: Instrument Calibration Matrix

    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) Calibrate: ⑥ Pivot points • Pointed instruments Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 28 Instrument Calibration Matrix Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 29: 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 30 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 31: Multiple Tip Pointer Package

    The Tip Set for Paint Pointer is designed for accessing sinus cavities and the tips are available for use in combination with Paint software features. Component Article No. ① Pointer Tip Structure Acquisition (Curved) 55791-06 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 32 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 33: Softouch Pointer

    (visible) status 4x long flash Turning off Orange Continuous Battery low Not functioning Continuous Battery empty properly 15x flashing Error is detected NOTE: The Softouch Pointer turns off automatically after two minutes. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 34 Softouch may be used for unsterile procedures only. For cleaning and disinfection instructions, see the Cleaning, Disinfection, and Sterilization Guide. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 35 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 36 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 37: 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 38 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 39: 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 40 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 41: 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 42 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 43: 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 44 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 45 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 46: Z-Touch Laser Pointer Technical Information

    Once the laser beam is out of the field of view, the glare ceases. Dimensions, Weight and Material Dimension Value Height 4.4 cm Length 22.2 cm Width 3.8 cm Weight 160 g Material PC/ABS blend (polycarbonate/acrylonitrile butadiene styrene) Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 47 Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3, as described in Laser Notice No. 56, dated May 8, 2019. Internally Powered ME Equipment for Continuous Operation IEC 60601-1 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 48 Z-touch Laser Pointer Technical Information Classifications According to IP44 IEC 60529 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 49: Electromagnetic Compatibility

    Softouch and Z-touch use RF energy only for its internal function. Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Softouch and Z-touch are suitable for use in all establishments other than domestic and those Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 50 Portable RF communications equipment (including peripherals like antenna cables and external antennas) should not be used closer than 30 cm from any part of the Softouch or Z-touch including cables specified by Brainlab. Otherwise, degradation of the performance could result.
  • Page 51 NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 52 Electromagnetic Compatibility Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 53: References

    • One for intraoperative navigation. The reference array used for navigation must be sterilized before use and attached during draping. NOTE: Verify registration accuracy after exchanging the unsterile reference array for the sterile reference array and verify that it is rigidly fixated. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 54 Standard Cranial Reference Array Compatibility Name Compatibility Article • Reference Clamp Universal Standard Cranial Reference Array with 41725 4 Marker Spheres • Vario Reference Arm Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 55: Positioning Arrays

    Do not move a reference array relative to the patient’s anatomy during the procedure. Changing the array position alters 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 56 Positioning Arrays Warning If the position of the reference array changes relative to the patient, a new registration is required. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 57: Reference Clamp Universal

    How to Attach the Reference Clamp to the Head Holder ⑤ ④ ⑥ ③ ② ① Figure 19 Step Make sure that the patient’s head is rigidly fixed in the head holder. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 58 Warning Do not unscrew any Reference Clamp Universal screws after registration. Only the fixation nut can be unscrewed to exchange the Standard Cranial Reference Array. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 59 REFERENCES Only use identical reference arrays (3-marker with 3-marker or 4-marker with 4-marker) in combination with the Reference Clamp Universal. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 60: Vario Reference Arm (Mayfield Headholder)

    The Vario Reference Arm could fall on the patient. Warning Loosen the mechanism by turning the central tension handle counterclockwise until it stops and avoid using any additional force. Hold the articulated arm firmly with one hand Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 61 The V-inset is used as an interface that is mounted to the headholder enabling the simultaneous use of the reference arm and biopsy instrument holder. Component Article No. V-inset for Mayfield Head Holder 52003 ① V-inset for IMRIS Head Holder 52005 V-inset for GE Head Holder 52006 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 62: 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 (Mayfield Headholder) can be adjusted by hand. No additional tools are required. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 63 NOTE: Tightly close the central tension handle to prevent unintentional loosening. The Vario Reference Arm (Mayfield Headholder) has a limited load capacity. Do not load the Vario Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 64 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 65: Reference Headband

    The Reference Headband and Reference Unit for Headband is a reference device used especially for cases where head fixation is not possible. Before Using Only use the Reference Headband with Brainlab navigation systems. If you calibrate instruments using the calibration point, refer to the Software User Guide. Components ①...
  • Page 66 (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. 2.6 Cranial/ENT Optical Tracking...

  • Page 67: 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 68: 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 69: 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 70 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 71 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 72 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 73: Removing The Skull Reference Package

    ① Figure 33 Step Unscrew and remove the Skull Reference Array. Loosen the tube cap nut ①. Remove the screw with the screwdriver. Remove the Skull Reference Base by pulling it upwards. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 74 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 75: Instrument Adapters

    ③ Figure 35 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 76 Ensure that you use the correct size Instrument Adapter Clamp according to the diameter of the instrument. Warning Do not use on conical instruments. Warning Only use on metal surfaces. Warning Only use on non-motorized instruments. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 77 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. How to Attach the Clamp to the Instrument ② ① Figure 37 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 78 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 79: Instrument Adapter Accessories

    Instrument Adapter Clamp and Instrument Adapter Array where more space is required. NOTE: In case of impacts being placed onto the navigated instrument, it is recommended to use the Instrument Adapter Extension 50 mm with the Instrument Adapter Clamp Softgrip. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 80 Insert the array stem ① into the adapter extension ② also aligning the teeth on both com- ponents. Tighten the screw knob ④ 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 81: 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 82 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 83: Instrument Adapter Clamp Softgrip (Size L, Xl)

    Instrument Adapter Clamp Softgrip Size XL 55114 Instrument Adapter Array Size M 41798 Instrument Adapter Array Size ML 41799 ② Instrument Adapter Array Size L 41801 Instrument Adapter Array Size XL 41802 ③ Screwdriver (optional) 55758-30 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 84 Insert the array stem ② into the clamp ① and align the teeth of both components. Tighten the screw knob ③ by hand or by using the Screwdriver, ensuring that the array is securely attached to the clamp. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 85 Tighten the fixing knob ② by hand to secure the instrument adapter clamp. NOTE: Use the screwdriver if needed. Verify that the adapter is securely attached to the instrument, does not contact the patient and does not hinder the physician. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 86 Instrument Adapter Clamp Softgrip (Size L, XL) Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 87: Ultrasound

    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. NOTE: The probes listed in this user guide may not have been approved for intraoperative neurosurgical procedures in all countries.
  • Page 88 • 41860-36 Adapter Base (Aloka UST-9133) NOTE: Due to regulatory and technical limitations Ultrasound Navigation Adapter Base (BK X18L5s) is not compatible with BK Flex Focus 800 Hockey Stick probes (REF 8809). Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 89: Attaching The Unique Fit Adapter Base To The Probe

    Figure 46 Step Slide the Ultrasound Navigation Adapter Base ② over the probe ①. Make sure that the adapter is tightly attached and fits securely to the edge of the probe ③ Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 90 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 91: Generic Ultrasound Adapter Base Kit

    7.1.2 Generic Ultrasound Adapter Base Kit General Information Generic Ultrasound Adapter Base Kit can be used with Brainlab ultrasound and cranial navigation systems. For further information read the Software User Guides for Cranial/ENT and Ultrasound. For tracking, the Ultrasound Integration Adapter Array (22595) is required.
  • Page 92 Feed the hook and loop band under the probe ③ and through the metal loop and pull tight. Close the clasp ④ ensuring a tight fit. Drape the adapter base ⑥, attach the array ⑤ and calibrate. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 94 Ultrasound Calibration Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 95: Trajectory Alignment Tools

    VarioGuide General Information The VarioGuide (55950) is an instrument holder that attaches directly to head holders in order to navigate frameless biopsies and catheter placements. Components ② ③ ① ④ Figure 52 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 96 It can be safely used in the MR environment under the following condi- tions: • MR environment with 1.5 or 3.0 Tesla scanner. • To prevent autonomous acceleration, do not move VarioGuide across the 5 Gauss (0.5 mTesla) line. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 97: Assembly

    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. 2.6 Cranial/ENT Optical Tracking...
  • Page 98 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 99 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 100: Attaching The Varioguide To The Head Holder

    Skull Clamp for Biopsy Arm/Varioguide (19223-03) to the head holder interface. NOTE: Also attach the Radiolucent Adapter for DORO Skull Clamp. Place the “T” screw directly onto the head holder, V-inset, or interface, thereby puncturing the drape ①. Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 101 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. 2.6 Cranial/ENT Optical Tracking...
  • Page 102 Attaching the VarioGuide to the Head Holder Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 103: 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 104 A Microscope Adapter Set consists of: • A microscope adapter ① • A Microscope Tracking Array ② 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 105: Draping

    Tighten the fixation screw and ensure that the connection is secure. 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 106: 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. 2.6 Cranial/ENT Optical Tracking...

  • Page 107: 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 61 Haag-Streit Hi-R 1000/Hi-R 700 (41767-85) ① ② Figure 62 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 108 Available Microscope Adapter Kits Zeiss OPMI Pentero, OPMI PENTERO 800, OPMI PENTERO 900, KINEVO 900, OPMI VARIO 700 (41767-55) ① ② Figure 63 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...

  • Page 109: Index

    57 reference headband..............65 reusable suction tubes............... 25 safe disposal................6 skull reference package............. 67 softouch..................33 safety..................34 suction tubes................24 support numbers................5 sustainability.................6 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking...
  • Page 112 Art-No. 60921-34US *60921-34US*...

Table of Contents

Save PDF