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4.5

Electromagnetic Compatibility

Electromagnetic Compatibility: Declaration

Softouch

 and 

Z-touch

 require special precautions regarding electromagnetic compatibility and

must be installed and put into service according to the electromagnetic compatibility information
provided in this guide.

Portable and mobile radio frequency communication may affect Softouch and Z-touch.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.

 

Electromagnetic Environment

Floors should be wood, concrete, or ceramic tile to reduce electrostatic discharge. If floors are
covered with synthetic material, the relative humidity should be at least 30%. Power frequency
magnetic fields should be at levels characteristic of a typical location in a typical commercial or
hospital environment.

Electromagnetic Immunity

Standards

Immunity Test

IEC 60601 Test Level

Compliance Level

IEC 61000-4-3 Radiated RF

3 V/m (80 MHz to 2.7
GHz)

80% AM at 1 kHz

+ Test frequencies of RF
wireless communication
equipment acc. to IEC
60601-1-2

3 V/m (80 MHz to 2.7
GHz)

80% AM at 1 kHz

+ Test frequencies of RF
wireless communication
equipment acc. to IEC
60601-1-2

IEC 61000-4-8

Power frequency mag-
netic field

30 A/m + 50/60 Hz

30 A/m + 50/60 Hz

IEC 61000-4-2 Electrostatic discharge

±2 kV, ±4 kV, ±8 kV, ±15
kV air

± 8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15
kV air

± 8 kV contact

Portable and mobile RF communications equipment can affect 

Softouch

 and 

Z-touch

a

. Field

strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

a

 should be

less than the compliance level in each frequency range.

b

NOTE: 

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Softouch / Z-touch is used exceeds the applicable RF
compliance level above, the Softouch / Z-touch should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the Softouch / Z-touch.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

 

Electromagnetic Emissions

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

POINTERS

Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

49

Содержание CRANIAL/ENT OPTICAL TRACKING

Страница 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 ...

Страница 2: ......

Страница 3: ... Suction Tubes 24 3 2 1 Reusable Suction Tubes 25 3 3 Instrument Calibration Matrix 27 4 POINTERS 29 4 1 Navigation Pointer Cranial ENT 29 4 2 Multiple Tip Pointer Package 31 4 3 Softouch Pointer 33 4 3 1 Softouch Pointer Technical Information 37 4 4 Z touch Laser Pointer 39 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...

Страница 4: ... Instruments 81 6 3 Instrument Adapter Clamp Softgrip Size L XL 83 7 ULTRASOUND 87 7 1 Ultrasound Adapters 87 7 1 1 Attaching the Unique Fit Adapter Base to the Probe 89 7 1 2 Generic Ultrasound Adapter Base Kit 91 7 1 3 Ultrasound Calibration 93 8 TRAJECTORY ALIGNMENT TOOLS 95 8 1 VarioGuide 95 8 1 1 Assembly 97 8 1 2 Attaching the VarioGuide to the Head Holder 100 9 MICROSCOPES 103 9 1 Microscop...

Страница 5: ...ica Asia Australia Europe Tel 49 89 991568 1044 Fax 49 89 991568 5811 Japan Tel 81 3 3769 6900 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 Feedback...

Страница 6: ...y one or more patents or pending patent applications For details see www brainlab com patent Disposal Instructions When a surgical instrument reaches the end of its functional life clean the instrument of all biomaterial biohazards and safely dispose of the instrument in accordance with applicable laws and regulations Only dispose of electrical and electronic equipment in accordance with statutory...

Страница 7: ...ed Part NOTE Applied parts that have conductive contact with the patient or have medium or long term contact with the patient Caution NOTE User should consult the instructions for use for important cautionary informa tion such as warnings and precautions that cannot for a variety of reasons be pre sented on the medical device itself Equipotentiality NOTE To identify the terminals which when connec...

Страница 8: ...ed Atmospheric pressure limitation NOTE Indicates the range of atmospheric pressure to which the medical device can be safely exposed Quantity of included items Manufacturer s batch code Manufacturer s serial number Reference article number NOTE Indicates Brainlab s product number 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 ...

Страница 9: ...o known hazards in a specific MR environment MR Unsafe NOTE Presents hazards in all MR environments MR Safe NOTE Presents no known hazards in any MR environment Switch to bring the device into standby mode Switch to turn the device on off Contains or presence of natural rubber latex NOTE Presence of natural rubber or dry natural rubber latex as a material of con struction within the medical device...

Страница 10: ...ment Unique Device Identifier Single sterile barrier system with protective packaging inside Double sterile barrier system Follow instructions for use Medical Device Symbols 10 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 11: ...T 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 Handle them carefully GENERAL INFORMATION Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 11 ...

Страница 12: ... vary depending upon the Brainlab product If you have questions regarding the user guides you received please contact Brainlab support User Guide Contents Software User Guides Overview of treatment planning and image guided navigation Description of OR system setup Detailed software instructions Hardware User Guides Detailed information on radiotherapy and surgical hardware typi cally defined as l...

Страница 13: ...in this user guide are highly accurate and sensitive medical devices and must be handled with extreme care If you drop or otherwise damage an instrument or if an instrument is corroded or defective in any way immediately call your local 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 Warni...

Страница 14: ... occur infection local pain bleeding lesion of blood vessels or nerves bone fracture or thrombosis Creutzfeldt Jakob Contamination Warning Do not use Brainlab instrumentation on patients suspected of having Creutzfeldt Jakob disease CJD or vCJD Sterilization If a sterile and reusable instrument or any of its components is inadvertently removed from the sterile field or comes into contact with an u...

Страница 15: ... Navigation Pointer Cranial ENT 41780 5 INSTRUMENTATION OVERVIEW Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 15 ...

Страница 16: ...s in the sterile barrier system integrity prior use Yes Yes Disposable Stylet NOTE Not detailed in this user guide See sepa rate instructional leaflet for further information NOTE Visually inspect for breaches in the sterile barrier system integrity prior use Yes No Reusable Suction Tubes No Yes Instrument Calibration Matrix Yes Yes Pointers Illustration Name Cranial ENT Pointer Cranial ENT with B...

Страница 17: ...pters Illustration Name Cranial ENT Instrument Adapter Package NOTE Instrument Adapter Array Starlink Size M only to be used for ENT Yes Yes Instrument Adapter Clamps for Rectangular Cylindrical Instruments Yes Yes Instrument Adapter Offset link 45 20 mm Yes Yes Instrument Adapter Extension 50 mm Yes Yes Ultrasound Illustration Name Cranial ENT Ultrasound Adapters Yes No INSTRUMENTATION OVERVIEW I...

Страница 18: ...Alignment Tools Illustration Name Cranial ENT VarioGuide Yes No V Insets Yes No Microscope Adapters Illustration Name Cranial ENT Microscope Tracking Array and Adapter Sets Yes No Available Instruments and Classification 18 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 19: ... 5 x 6 mm maxDrive drill free Martin or Cor tex Screw PlusDrive self drill Synthes Gebrüder Martin GmbH and Co KG Ludwigstaler Str 132 78532 Tuttlingen Germany Synthes GmbH Eimattstr 3 4436 Oberdorf Switzerland Yes Yes Screwdriver blade 1 5 mm appropriate for used screws Yes Yes Screwdriver handle Appropriate for used blade and screws Yes Yes Drill bit and handle optional 1 1 mm Yes Yes Disposable...

Страница 20: ...Available Instruments and Classification 20 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 21: ...d with the above marker spheres The use of other marker spheres could affect navigation accuracy posing a risk to the patient When to Attach Marker Spheres Attach marker spheres to instruments and arrays before calibration or use in surgery Ensuring Sterility Disposable Reflective Marker Spheres are delivered sterile They cannot be resterilized and must be disposed of after use Warning Do not rest...

Страница 22: ...herwise navigation is not possible or may be inaccurate Cleaning Marker Spheres Warning To clean the surface of soiled marker spheres use a soft cloth moistened with sterile water only Ensure that the cleaned marker sphere is absolutely dry before use NOTE If you clean or replace a marker sphere on an instrument or reference array verify navigation accuracy before continuing Attaching Marker Spher...

Страница 23: ... sphere and use a new one 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 GENERAL INSTRUMENTATION Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 23 ...

Страница 24: ...eusable and disposable suction tubes are optically tracked surgical suction devices for use in Brainlab navigated surgical ENT reusable suctions or cranial disposable suctions procedures Suction Tubes 24 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 25: ...anded Left Handed Frontal Sinus Double angled 120 near handle 110 tip 8 Frazier tip 55790 25 55790 15 Maxillary Si nus 110 8 Pear tip 55790 50 n a Frazier tip 55790 55 10 Frazier tip 55790 65 Standard 135 8 Pear tip 55790 05 Frazier tip 55790 75 10 Pear tip 55790 Frazier tip 55790 70 Calibration Always recalibrate the tip after every adapter exchange GENERAL INSTRUMENTATION Instrument User Guide R...

Страница 26: ...alibrated the standard suctions tubes Frazier tip in ICM receptacle The offset is based on the different suction tube sizes in combination with the different reference arrays as shown in the table below Reusable Suction Tube Size Offset when Verification in 4 Marker Reference Array Cone Calibration Method 8 Charr REF 55790 75 1 0 mm Receptacle 10 Charr REF 55790 70 1 2 mm Receptacle Reusable Sucti...

Страница 27: ...alibrate Chisel tips Flat tipped instruments Reference Plane 4 Reference for Tip distance of instruments calibrated in the V inset Reference Plane 2 Manually determine the width of tips and to calibrate Chisel tips Flat tipped instruments Reference Plane 3 V inset Reference for Shaft diameter of instruments calibrated in the V inset Receptacle example Calibrate the long axis of Short shafts Shafts...

Страница 28: ...Instrument Calibration Matrix 28 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 29: ... verify that registration accuracy is maintained To verify the accuracy of acquired fluoroscopic images Pointer Gauge Figure 7 Each pointer comes with a gauge that serves to prevent pointer damage and ensure maximum accuracy 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 gaug...

Страница 30: ...ing 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 Navigation Pointer Cranial ENT 30 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 31: ...n a n a 55791 Pointer Tip 95 mm 20 mm 70 angle 30 55791 03 100 mm 20 mm 90 angle 0 55791 04 123 mm di ameter 3 4 mm n a 0 55791 34 60 mm n a 0 55791 05 150 mm n a 0 55791 01 Tip Set for Paint Pointer Figure 9 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 No Component Article No Pointer Tip Struc...

Страница 32: ...interface matches the hole at the bottom of the tracking array 5 Securely tighten the fixation screw using the Allen key provided or by hand Be aware that excessive force may damage the instrument or screw Calibrating Multiple Tip Pointers Calibrate the pointer prior to use see Software User Guide NOTE Exchanging the pointer tip or the instrument tracking array requires a new calibration NOTE The ...

Страница 33: ...atteries but with a reduced lifetime Components Figure 11 No Component Func tion Status Color Description Standby switch Switches device on off and places it in standby mode Turn on press the switch for less than one second Turn off press the switch for two seconds Infrared LED not visible Allows camera to track the pointer Status LED visible Pointer status Functioning properly Green Continuous Re...

Страница 34: ...ized use Safety Considerations Warning Only use Softouch on the patient s skin not on the eyes Warning Do not use Softouch on damaged skin Warning Do not use Softouch on loose skin that has no immediate contact with bony structures otherwise registration accuracy may be affected Warning Do not touch Softouch tip to metal when acquiring points on the patient s skin Warning Do not use with a dismoun...

Страница 35: ... marker spheres and infrared LEDs on Softouch Correct Handling Warning Make sure that the reflective marker spheres are not partially hidden when using Softouch Warning Do not drape Softouch otherwise navigation and registration might not work or accuracy could be affected Warning To achieve the best possible registration results only touch patient with very tip of Softouch Warning Handle the poin...

Страница 36: ...crews with moderate force Warning Do not change the Softouch battery within patient surroundings or while in contact with a patient During the battery exchange make sure that no liquids ingress inside the pointer housing 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 separ...

Страница 37: ... It can be safely used in the MR environment under the following conditions MR environment with 1 5 or 3 0 Tesla scanner To prevent autonomous acceleration do not move Softouch across the 5 Gauss 0 5 mTesla line Softouch may only be used in an MR environment with a 5 Gauss 0 5 mTesla line clearly indicated on the floor surrounding the MR scanner Do not use or activate Softouch during an MRI examin...

Страница 38: ... C to 50 C 14 F to 122 F 10 C to 35 C 50 F to 95 F Humidity 10 to 90 noncondensing 20 to 80 noncondensing Pressure 500 hPa to 1060 hPa 700 hPa to 1060 hPa Optical Specifications Specification Color Description Infrared LED N A Wavelength λ 870 nm IR A Visible status LED Green Wavelength λ 570 nm Red Wavelength λ 630 nm Certifications and Classifications Certification IEC 60601 1 Classifications Ac...

Страница 39: ...a during registration check the camera distance to the patient and either reduce the camera distance or check for the presence of other interfering light sources Before Use Warning Use of Z touch is strictly limited to medical personnel familiar with laser products Inappropriate handling of laser equipment is a hazard to patients and clinical staff Correct Instrument Handling Warning Handle the po...

Страница 40: ...f 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 Z touch Laser Pointer 40 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 41: ...se Z touch Step 1 To activate the visible laser press the activation button The visible laser is activated immediately 2 The infrared laser beam is activated with a one second delay to the visible laser when the following are fulfilled The Z touch registration dialog is open in the navigation software The activation button is pressed The infrared sensor detects the camera 3 The laser beams are dea...

Страница 42: ...presence of a Brainlab navigation system is below the limits of Class 1 according to IEC 60825 1 2014 Z touch Laser Beams 42 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 43: ... is off Changing between yellow and green Z touch battery is low and both lasers are activated The battery typically lasts for one patient registration procedure Change the battery before us ing Z touch for the next patient registration Solid yellow If an internal error is detected both visible and infrared lasers are switch ed off and the indicator LED is solid yellow when the activation button i...

Страница 44: ...e Torx screwdriver size TX6 provided in the stor age case 2 Open the battery cover and remove the battery from the battery case by lifting the ribbon 3 Insert the new battery on top of the ribbon according to the orientation illustrated inside the battery case 4 Close the battery case cover taking care not to damage the fixation joints 5 Tighten the battery cover screw using the screwdriver NOTE D...

Страница 45: ... Cover Only open battery cover when necessary Do not try to open other parts of housing Independent laser beams are routed inside housing POINTERS Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 45 ...

Страница 46: ...ient field dB dt and the RF field B1 E in 1 5 Tesla and 3 0 Tesla MR systems passed all tests according to Brainlab testing procedure After use always store Z touch in the provided storage case outside the MR environment Possible Side Effects The eyes are probably the only area which can be damaged by the laser beam of Z Touch Laser Pointer The most likely side effects following exposure are Side ...

Страница 47: ...ingle laser pulse PP 5 6 mW Mean optical output power of laser pulse train Po 0 12 mW Collinearity n a Divergence angle of both lasers φ 2 mrad Environmental Specifications Specification Transport Storage Conditions Operating Conditions Temperature 10 C to 50 C 14 F to 122 F 10 C to 35 C 50 F to 95 F Humidity 10 90 noncondensing 20 80 noncondensing Pressure 500 hPa 1060 hPa 700 hPa 1060 hPa Recomm...

Страница 48: ...Classifications According to IP44 IEC 60529 Z touch Laser Pointer Technical Information 48 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 49: ...1000 4 2 Electrostatic discharge 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8 kV 15 kV air 8 kV contact Portable and mobile RF communications equipment can affect Softouch and Z toucha Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b NOTE aField strengths from fixed transmitters such...

Страница 50: ... electromagnetic fields that may interfere with other sensitive equipment and can itself be disturbed by other electromagnetic fields Separation Warning 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 ...

Страница 51: ...e to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 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...

Страница 52: ...Electromagnetic Compatibility 52 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 53: ...bes NOTE For all instruments with spherical or flat tips e g suction tubes be aware that a tip deviation occurs when verifying accuracy using the reference array cone Sterility Usually two reference arrays are used One for preoperative procedures patient registration The reference array used for registration may be unsterile as registration is usually performed in an unsterile environment One for ...

Страница 54: ...patibility Article No Standard Cranial Reference Array with 4 Marker Spheres Reference Clamp Universal Vario Reference Arm 41725 Standard Cranial Reference Array 54 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 55: ...al Preparation Before Registration Tightly screw marker spheres by hand onto the attachment pins of the reference array During Use Check regularly that the marker spheres remain tightly screwed onto the pins A new registration is required if the patient was repositioned after registration Warning Do not move a reference array relative to the patient s anatomy during the procedure Changing the arra...

Страница 56: ...Warning If the position of the reference array changes relative to the patient a new registration is required Positioning Arrays 56 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 57: ... on the Reference Clamp Universal Warning Ensure that the clamp handle is sufficiently tightened To avoid unintentional loosening of the fixation screw do not place excessive weight on the Reference Clamp Universal e g by either leaning on the device or placing additional instrumentation on it How to Attach the Reference Clamp to the Head Holder Figure 19 Step 1 Make sure that the patient s head i...

Страница 58: ...versal and secure it tightly with the handles and fixation nut from underneath the drape 4 Attach the drape to the reference array below the fixation nut using the sterile tape NOTE To remove the sterile array detach the tape loosen the handles open the fixation nut and lift the array off Patient Registration Warning Make sure that all screws of the Reference Clamp Universal are tightly closed bef...

Страница 59: ...y use identical reference arrays 3 marker with 3 marker or 4 marker with 4 marker in combination with the Reference Clamp Universal REFERENCES Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 59 ...

Страница 60: ... handle counterclockwise to loosen it 3 Adjust the arm to the desired position and securely re tighten the handle by turning it clockwise Loosening the Arm Warning Do not grip the Vario Reference Arm Mayfield Headholder at the ball joints while the central tension handle is unfastened as you could injure your fingers Warning Never loosen the central tension handle without gripping the articulated ...

Страница 61: ... used as an interface that is mounted to the headholder enabling the simultaneous use of the reference arm and biopsy instrument holder No Component Article No V inset for Mayfield Head Holder V inset for IMRIS Head Holder V inset for GE Head Holder 52003 52005 52006 REFERENCES Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 61 ...

Страница 62: ... carefully which instrumentation is attached to the headholder in addition to the Vario Reference Arm Mayfield Headholder Excessive weight can damage the headholder and endanger the patient Check with the manufacturer of the headholder if you are unsure of the weight limit of your headholder Attachment Mechanism Figure 23 No Component T screw V inset 52003 52005 52006 Central tension handle Refere...

Страница 63: ...Mayfield T Screw This could damage the drape and compromise the sterility and referencing accuracy Warning Do not unscrew the Mayfield T screw and or the central tension handle after patient registration The entire coordinate system will no longer be accurate and the instrument tip incorrectly displayed Only the fixation nut may be unscrewed to exchange the Standard Cranial Reference Array Warning...

Страница 64: ...er Figure 25 Step 1 Make sure that the patient s head is rigidly fixed in the headholder 2 Attach the connector of the Vario Reference Arm Mayfield Headholder to the head holder and fix it tightly using the T screw NOTE If you are using the optional V inset connect it to the headholder and then attach the reference arm to the V inset connector 3 Make sure that the teeth on both components are prop...

Страница 65: ... calibrate instruments using the calibration point refer to the Software User Guide Components Figure 26 No Component Article No Reference Headband 41878 Connector for Headband Reference Unit 41877 10 Reference Unit for Headband 41877 How to Attach the Reference Headband Figure 27 Step 1 Orient the Reference Unit for Headband so that the arrow points in the cranial direc tion as marked REFERENCES ...

Страница 66: ...rely fastened If the Reference Headband slips tracking is inaccurate Warning Do not readjust the Reference Headband during subsequent procedures The tracking will no longer be accurate and the instrument tip incorrectly displayed Warning If the Reference Headband is fastened too tightly during extensive surgery longer than two hours indentations may appear on the patient s head e g on the forehead...

Страница 67: ...y 52122 Handle for Blades KLS Martin 52127 Screwdriver Blade KLS Martin 52171 Disposable KLS Martin Bone Fixation Screw 1 5 mm x 6 mm 5 PCS 52170 Sterility Use Instructions Article No Skull Reference Array Registration May be unsterile 52122 Navigation Must be sterilized Disposable KLS Martin Bone Fixation Screw 1 5 mm x 6 mm 5 PCS Must be sterilized 52170 NOTE If only one reference array is used ...

Страница 68: ...he screwdriver is sufficient for the removal of the screw from the bone Placing too much pressure on the head of the screw may cause the head of the screw to be torn out of the bone when the screwdriver is removed Excess pressure could also cause the head of the screw to split or break How to Assemble the Screwdriver Figure 29 Step 1 Pull back the front sleeve of the handle 2 Insert the screwdrive...

Страница 69: ...ement 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 If you decide that predrilling is necessary it should be performed according to the screw manufacturers guidelines The diameter of the drill bit us...

Страница 70: ...inserted 4 Insert the tube into the base through the bottom in the direction of the arrow and care fully fasten the tube cap nut on top 5 Place the assembled Skull Reference Base onto the patient s skull and insert the tube into the incision 6 Insert a Disposable KLS Martin Bone Fixation Screw 1 5 mm x 6 mm through the tube 7 Use the screwdriver to completely screw the screw into the bone until it...

Страница 71: ...ference Array down over the pin of the connector interface and tighten the array cap nut 2 Loosen the tube cap nut and the adjustment nut to set the position of the array so that it is visible to the camera 3 Securely tighten both and 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 refer...

Страница 72: ...crew and remove the unsterile reference array 2 Drape the patient as usual and make a slit in the drape to expose the connector interface 3 A sterile assistant or nurse should then attach the sterile array to the interface Assembly and Attachment 72 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 73: ...for Skull Reference Package removal Standard Procedure Figure 33 Step 1 Unscrew and remove the Skull Reference Array 2 Loosen the tube cap nut 3 Remove the screw with the screwdriver 4 Remove the Skull Reference Base by pulling it upwards REFERENCES Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 73 ...

Страница 74: ...visual aid to position the screwdriver on the screw Unscrew and remove the screw with the screwdriver and lift the tube away 5 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 Removing the Skull Ref...

Страница 75: ...is allows you to assemble an instrument adapter to suit the instrument you wish to navigate Components Figure 35 No Name Article No Instrument Adapter Clamp Size S Instrument Adapter Clamp Size M Instrument Adapter Clamp Size L Instrument Adapter Clamp Size XL 55101 55102 55103 55104 INSTRUMENT ADAPTERS Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 75 ...

Страница 76: ...re continuing Proper Handling of Instrument Adapters Warning Ensure the adapter array is large enough for the instrument The larger the instrument the larger the adapter array you should use An adapter array that is too small can result in imprecise calibration or navigation Warning Ensure that you use the correct size Instrument Adapter Clamp according to the diameter of the instrument Warning Do...

Страница 77: ...e larger the array you should use 2 Insert the array stem into the clamp and align the teeth on both components 3 Tighten the screw knob 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 Figure 37 INSTRUMENT ADAPTERS Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 77 ...

Страница 78: ... possible without touching the patient 2 Attach the array so that the longest arm of the array is in line with the instrument axis 3 Tighten the fix knob by hand to secure the instrument adapter clamp NOTE Use the Tool for Instrument Adapter if needed Arrays and Clamps 78 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 79: ...mponents 2 Tighten the offset link screw to secure it to the adapter clamp 3 Attach the array to the offset link Instrument Adapter Extension 50 mm Figure 38 The Instrument Adapter Extension 50 mm 55016 is designed to be used between an 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 recomme...

Страница 80: ...rt the adapter extension into the clamp aligning the teeth on both components 3 Insert the array stem into the adapter extension also aligning the teeth on both com ponents 4 Tighten the screw knob by hand or by using the Tool for Instrument Adapter ensur ing that the array is securely attached to the clamp Instrument Adapter Accessories 80 Instrument User Guide Rev 2 6 Cranial ENT Optical Trackin...

Страница 81: ...ar Instruments 55105 Instrument Adapter Clamp Cylindrical Instruments 55110 How to Attach the Clamp Figure 41 Step 1 For rectangular instruments attach the adapter 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 3 Attach the relevant Instrument Adapter Array to the adapte...

Страница 82: ...trument for navigation 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 Adapter Clamps for Rectangular Cylindrical Instruments 82 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 83: ... Do not use on conical instruments Warning Only use on metal surfaces Warning Only use on non motorized instruments Warning Ensure that you use the correct size Instrument Adapter Clamp Softgrip according to the diameter of the instrument Components Figure 42 No Component Article No Instrument Adapter Clamp Softgrip Size L Instrument Adapter Clamp Softgrip Size XL 55113 55114 Instrument Adapter Ar...

Страница 84: ...ent Adapter Clamp Softgrip Figure 43 Step 1 Select your Instrument Adapter Clamp and Instrument Adapter Array NOTE The larger the instrument the larger the array you should use 2 Insert the array stem into the clamp and align the teeth of both components 3 Tighten the screw knob by hand or by using the Screwdriver ensuring that the array is securely attached to the clamp Instrument Adapter Clamp S...

Страница 85: ...atient 2 Attach the array so that the longest arm of the array is in line with the instrument axis 3 Tighten the fixing knob by hand to secure the instrument adapter clamp NOTE Use the screwdriver if needed 4 Verify that the adapter is securely attached to the instrument does not contact the patient and does not hinder the physician INSTRUMENT ADAPTERS Instrument User Guide Rev 2 6 Cranial ENT Opt...

Страница 86: ...Instrument Adapter Clamp Softgrip Size L XL 86 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 87: ...calibrated using the Ultrasound Registration Phantom Warning Any movement of the probe independent from the adapter will cause inaccuracy during navigation endangering the patient Before attaching an adapter to the ultrasound probe make sure you select the correct adapter for your probe Ultrasound adapters are designed for specific ultrasound probes If it is difficult to attach the adapter on the ...

Страница 88: ...d Integration Adapter Base Aloka UST 9133 41860 5 41860 36 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 Ultrasound Adapters 88 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 89: ...5 is also required for tracking purposes How to Attach the Unique Fit BK Medical Adapter Base The following procedure is relevant for Ultrasound Navigation Adapter Base BK 8862 8863 N11C5S Ultrasound Navigation Adapter Base BK N13C5 Ultrasound Navigation Adapter Base BK X18L5s Figure 46 Step 1 Slide the Ultrasound Navigation Adapter Base over the probe 2 Make sure that the adapter is tightly attac...

Страница 90: ...dapter How to Attach the Adapter Array to the Adapter Base Figure 48 Step 1 Place the sterile array onto the draped adapter base Align the array so that the teeth of the adapter array match the indentations of the adapter 2 Securely tighten the fixation nut by turning it clockwise NOTE If you remove the adapter array from the probe the adapter array and the drape become unsterile To continue navig...

Страница 91: ...tracking the Ultrasound Integration Adapter Array 22595 is required Components Figure 49 No Product Article No Generic Ultrasound Adapter Base reusable device 41860 42 Hook and Loop Band Size S for Generic Adapter single use 3 PCS 41860 44 Hook and Loop Band Size M for Generic Adapter single use 3 PCS 41860 45 Hook and Loop Band Size L for Generic Adapter single use 3 PCS 41860 46 ULTRASOUND Instr...

Страница 92: ...se on the ultrasound probe and verify that the orientation with the probe tip is correct 3 Feed the hook and loop band under the probe and through the metal loop and pull tight 4 Close the clasp ensuring a tight fit 5 Drape the adapter base attach the array and calibrate Generic Ultrasound Adapter Base Kit 92 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 93: ...e calibration of various ultrasound probes NOTE The phantom must be draped with the Ultrasound Registration Phantom Drape 22531 before use Correct Calibration Make sure that the ultrasound probe is calibrated within the same conditions as it is used in the workflow e g if navigation is performed with a draped probe calibration should also take place with the drape If the probe is sterilizable and ...

Страница 94: ...Ultrasound Calibration 94 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 95: ...ion The VarioGuide 55950 is an instrument holder that attaches directly to head holders in order to navigate frameless biopsies and catheter placements Components Figure 52 TRAJECTORY ALIGNMENT TOOLS Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 95 ...

Страница 96: ...mp Radiolucent 3034 00 Interface Skull Clamp Radiolucent 3033 50 Optional V inset for Mayfield Head Hold er 52003 Mizuho Sugita Head Frame 07 951 00 07 951 11 Mizuho Navigation Adaptor 07 970 50 Noras MRI Prod ucts Flexibil ity OR Head Holder Flexibility Rev 1 3 Coil Fixation System 65mm 114464 117901 VarioGuide Adapter 111815 Heid berg OR Head Holder Upgrade Kit Heid berg Rev 1 2 Coil Fixation Sy...

Страница 97: ...int 1 by tightening the screw clockwise 4 Insert the Joint 2 lock partway into the disc joint 5 Screw the array holder into the disc joint until the lines on both compo nents are aligned securing it by tightening the Joint 2 screw General Safety Considerations Warning Never loosen the joints while an instrument is inserted into the patient through the VarioGuide except for joint 1 in order to swin...

Страница 98: ...ockwise Guide Disc Safety Considerations Warning To ensure secure and reliable instrument positioning and to prevent instrument movement within the revolver or Guide Disc the central tension handle the guiding arm s screws and the Guide Disc must be tightly secured by hand Warning Always check that the Guide Disc is mounted correctly to the VarioGuide and is not tilted or blocked Warning Always ch...

Страница 99: ... bend the instrument Warning Each modification of the Guide Disc or change in instrument diameter requires the VarioGuide to be re aligned to the trajectory How to Attach the Disc Set Figure 55 Step 1 Place the inner disc onto the array holder until it clicks into position NOTE Align the required diameter on the inner disc to the arrow on the array 2 Screw the two outer discs together 3 Align the ...

Страница 100: ... of the drill is not carried by the VarioGuide arm When exerting force on the inserted instrument ensure that the force does not change the VarioGuide s trajectory Warning Ensure that the head holder is properly mounted and that the total load does not exceed the limits specified in the manufacturer s manual Excess load could loosen the clamp and endanger the patient How to Attach the VarioGuide t...

Страница 101: ... 1 Position the VarioGuide as required securing it tightly with the central tension handle 2 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 TRAJECTORY ALIGNMENT TOOLS Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 101 ...

Страница 102: ...Attaching the VarioGuide to the Head Holder 102 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 103: ...pter Set must be attached to the microscope The microscope must be connected to the navigation system Before Using Read the Software User Guide before performing microscope navigation Cabling Warning Do not connect additional hardware to the original setting after calibration Warning Do not connect devices other than a valid calibrated video camera to the video port of the navigation system Warnin...

Страница 104: ...hould not be removed Warning Do not loosen the attachment screws between the microscope adapter and the optical head Contact Brainlab support if the microscope adapter has been removed or repositioned Do not remove and re attach or reposition the microscope adapter after the microscope has been calibrated This will cause the virtual microscope pointer and all related views to be inaccurate Microsc...

Страница 105: ...ensure that microscope movement will not damage the drape How to Attach the Array to the Adapter Figure 59 Step 1 Attach the Microscope Tracking Array to the Microscope Adapter 2 Place the Microscope Tracking Array on the draped Microscope Adapter so that the teeth match 3 Tighten the fixation screw and ensure that the connection is secure Warning Ensure that the marker spheres can be screwed onto...

Страница 106: ...h of adapter 2 Attach microscope tracking array to microscope adapter and tighten fixation screw Make sure that the screw connection is secure 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 Attaching t...

Страница 107: ...ow the microscope tracking array attached to the microscope adapter In the standard orientation At a 90 angle Leica M500 N M520 M525 M530 M720 SAI 41767 70 Figure 61 Haag Streit Hi R 1000 Hi R 700 41767 85 Figure 62 MICROSCOPES Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking 107 ...

Страница 108: ...Zeiss OPMI Pentero OPMI PENTERO 800 OPMI PENTERO 900 KINEVO 900 OPMI VARIO 700 41767 55 Figure 63 Available Microscope Adapter Kits 108 Instrument User Guide Rev 2 6 Cranial ENT Optical Tracking ...

Страница 109: ...r 106 P pointer multiple tip 31 R reference arrays positioning 55 standard cranial reference array 53 reference clamp universal 57 reference headband 65 reusable suction tubes 25 S safe disposal 6 skull reference package 67 softouch 33 safety 34 suction tubes 24 support numbers 5 sustainability 6 U ultrasound adapters 87 aloka adapter base 90 attaching adapter arrays to the adapter base 90 bk medi...

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Страница 112: ...brainlab com Art No 60921 34US 60921 34US ...

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