Warnings and Indications

Please consult BrightMatter user manuals for complete and up to date information.

Simulate

INDICATIONS FOR USE

Synaptive BrightMatter™ Brain Simulators are an integrated simulation solution for minimally invasive neurosurgeries. They consolidate the critical steps of image-guided neurosurgery, including imaging, planning, navigation, and resection into a single training solution.

BrightMatter Brain Simulator brains are educational devices intended to simulate the structural, tactile and other properties of the human head region. The device contains no biological material and is made of synthetic materials classified as harmless by WHMIS and HMIS. Refer to the included MSDS documentation for details.

WARNINGS AND CAUTIONS

Although BrightMatter Brain Simulator brains are made from a material classified as nonhazardous, unpredictable reactions are always possible. For maximum protection, wear gloves when handling the brain.

DISPOSAL

There are no special requirements for disposing of the BrightMatter Brain Simulator components. Observe local waste disposal laws and regulations

Plan

INDICATIONS FOR USE

BrightMatter Plan is indicated for:

  • Viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and image segmentation where the output can be stored in a PACS server. Such data can be subsequently consumed by an image guided surgical system; however, the latter is not within the scope of BrightMatter Plan software.
  • Planning and simulation of cranial surgical procedures and for reviewing of existing treatment plans.

Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.

CONTRAINDICATIONS

The BrightMatter Plan software tool is not intended for final interpretation in Full-field Digital Mammography.

WARNINGS AND CAUTIONS

  • BrightMatter Plan has been designed for use by trained, qualified, medical professionals. Federal law restricts this device to sale by or on the order of a surgeon.
  • BrightMatter Plan does not choose or recommend any particular planned trajectory. It is the responsibility of the medical professional to choose the most effective trajectory based on clinical knowledge.
  • BrightMatter Plan does not detect high-risk trajectories. It is the responsibility of the medical professional to choose the most effective trajectory based on clinical knowledge.

USE CAUTION WHEN INTERPRETING IMAGES

  • Tract information displayed in BrightMatter Plan is based on diffusion data; it does not necessarily correspond to nerve bundles.
  • The diffusion tract colors are based on the axes of the scanner. If the patient’s head is not aligned with the scanner, the colors will not map to the patient axes.

RISKS ASSOCIATED WITH POOR IMAGE QUALITY OR MISSING DATA

  • Accepting series with poor diagnostic quality may impede location of appropriate surgical targets and regions of interest.
  • Using image data that does not cover the complete brain may prevent selection of the optimal surgical plan.
  • Accepting an image series with low resolution will impact the accuracy of the surgical plan.
  • If you do not accept the diffusion data, you will not be able to use tractography for trajectory planning.

RISKS ASSOCIATED WITH ACCEPTING BRIGHTMATTER PLAN VISUALIZATIONS

  • Accepting series with poor registration will lead to inaccuracy in plans and surgery.
  • The Window/Level settings may cause sulci to appear wider and deeper than they are.

ALWAYS VERIFY PATIENT DATA AND ORIENTATION

  • Using data from the wrong patient will lead to an incorrect surgical plan. Always verify that the patient name and demographic data in the study are correct.
  • BrightMatter Plan permits two views: radiological and surgical. Misunderstanding the view you are using could result in a surgical plan on the wrong side of the body. Always confirm the orientation of the patient using the orientation labels when creating and editing a trajectory.

DEDICATED INSTALLATION

Do not install any other software on the BrightMatter Plan workstation. Installing other software in the system or modifying the hardware will invalidate the tests conducted by the manufacturer to prove that the device is safe and effective.

INSTALLATION AND SERVICE

Only personnel approved by Synaptive Medical may install, alter, or otherwise provide service for the BrightMatter Plan software.

Guide

INDICATIONS FOR USE

BrightMatter Guide with SurfaceTrace Registration is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the “Accuracy Characterization” section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The system should be operated only by trained personnel such as surgeons and other clinic staff.

CONTRAINDICATIONS FOR USE

BrightMatter Guide System should not be used where fiducial structures on the patients cannot be accurately defined to corresponding locations on the image of the same patient.

BrightMatter Guide is not designed as a primary tool for disease detection or diagnosis.

BrightMatter Guide is not designed as a primary tool for assessing therapeutic outcomes.

WARNINGS AND CAUTIONS

Federal law (U.S.A.) restricts this device to sale by or on the order of a surgeon.

  • Use the Guide system for the indications specified in the user manual only.
  • Improper fixation of the patient’s head in the head holder may result in inaccurate registration or loss of registration during the procedure. Ensure that the patient’s head is properly fixed in the head holder before beginning a procedure.
  • Greater distance between the fiducial markers and the surgical site reduces the accuracy of registration. Always place some fiducial markers as close to the surgical site as possible and place additional fiducial markers around the head. Do not place all the fiducial markers in a concentrated area.
  • Use caution when draping patients and equipment. Always follow all applicable draping protocols and protocols for sterilizing equipment and maintaining a sterile field.
  • Use caution when applying the point of the pointer tool to any tissue. Do not apply pressure sufficient to damage the tissue.
  • Always inspect all tools for damage prior to surgery. Never use a tool that appears corroded, damaged, bent, or otherwise distorted from its intended shape.
  • Infrared sources in the operating room may interfere with Guide tracking. Remove any sources of infrared signals from the operating room before performing a procedure with Guide.
  • Loss of power will result in loss of tracking capability. If power to the Guide system is cut off, restore the power or follow your site’s established protocols to end the procedure
  • The Guide system may be installed and serviced only by qualified Synaptive Medical Service representatives. There are no user-serviceable parts in the Guide system.
  • No modification of the Guide system equipment is allowed.
  • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
  • The power cord is the means to disconnect power to the carts. Do not position the carts such that they are difficult to unplug.
  • Use caution when moving the Guide system carts to prevent collisions with people or stationary objects such as equipment, doorways, or walls.
  • Do not roll the Guide system carts over cabling.
  • The drawer on the operator cart can support a maximum of 1kg (2.2 lbs). Weight over this limit may cause the drawer to break or the operator cart to tip over during movement.
  • Do not lean on the operator cart drawer or any other Guide system component.
  • Do not move the auxiliary cart with the tracking camera arm extended. Collapse the tracking camera arm before moving the auxiliary cart.
  • Do not use Cidex or other disinfectants to clean any of the Guide components. Only those components listed as sterilizable in the user manual may be sterilized.
  • The Guide system may be used only with the tools and equipment made or validated by Synaptive Medical. Do not bring any trackable instruments not made by Synaptive Medical into the Synaptive tracker camera field of view. Do not use any tools or equipment not listed in this user guide with the system. Do not connect any equipment not specified in the manual to the Guide carts.
  • Always lock all casters on the operator and auxiliary carts to prevent them from moving during the procedure.

DISPOSAL

No part of the Guide system may be disposed of in landfill. Dispose of the cranial reference drape, BrainPath Tracking Array and the passive reflective markers as pathological waste. Contact Synaptive Customer Service to dispose of the Guide carts, laptop, pointer tool, and calibration block.

Drive

INDICATIONS FOR USE

BrightMatter Drive is a positioning system for optical devices used for extracorporeal visualization of the operating field during surgery.

BrightMatter Drive is ideally suited for cranial and spinal applications in neurosurgery. Further fields of application include oral and maxilla-facial surgery.

The system may be operated only by trained personnel such as surgeons and other clinic staff.

CONTRAINDICATIONS

BrightMatter Drive is not an endoscope and must, therefore, only be used outside the body.

WARNINGS AND CAUTIONS

  • Federal law restricts this device to sale by or on the order of a surgeon.
  • Use Drive for the indications specified in the user manual only.
  • Always inspect the Drive system prior to surgery. Do not use the system if it appears to be damaged or malfunctioning in any way.
  • Do not connect any equipment not specified in the manual to the Drive system.
  • This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as reorienting or relocating the equipment or shielding the location.
  • Use caution when draping patients and equipment. Always follow the draping instructions, all applicable draping protocols, and protocols for sterilizing equipment and maintaining a sterile field.
  • Be careful to install optical devices on Drive as described in the manual. Installing an optical device incorrectly may cause it to fall from, or collide with, the positioning arm.
  • To avoid accidentally colliding with the patient, surgeon or surgical tools, never initialize Drive while the positioning arm is within range of the patient.
  • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth
  • Unplugging the power cord is the means to isolate Drive from the supply mains. Do not position Drive such that it is difficult to unplug.
  • Always route cables as described in the manual. Improperly routed cables may fray and cause an electrical shock hazard.
  • The cables connecting equipment to the Drive mobile base present a tripping hazard. Use caution when moving around Drive.
  • Use caution when adjusting the height of the surgical table to ensure the patient does not collide with the Drive positioning arm.
  • The light from optical devices is bright enough to cause temporary blindness or patient discomfort. Use caution when moving the positioning arm around the patient’s face.
  • Use caution when moving Drive to prevent collisions with people, equipment, or stationary objects.\The Drive system may be installed and serviced only by qualified Synaptive Medical Service representatives. There are no user-serviceable parts in the Drive system.
  • No modification of the Drive system equipment is allowed.
  • To prevent possible damage to the optical device cables, route the cables when the positioning arm is in a position that approximates the clinical use position. Do not significantly change the position of the arm (for example to switch the location of Drive to the opposite side of the patient) after the optical device has been installed and the cables have been routed.
  • No part of Drive is intended to support a person’s weight. Do not lean on the positioning arm. This may damage the positioning arm or cause the Drive to tip. Do not lean, sit, or step on the mobile base.
  • Use caution when moving Drive to prevent collisions with people or stationary objects such as equipment, doorways, or walls.
  • Do not roll the Drive mobile base over cabling.
  • Use caution when rolling Drive over bumps and thresholds to avoid damaging the system.

ELECTROSTATIC DISCHARGE (ESD) SAFETY

Do not touch components identified with the ESD warning symbol. Do not use these components without taking ESD precautions.

DISPOSAL

No part of the Drive system may be disposed of in landfill. Dispose of the drapes as pathological waste. Contact Synaptive Customer Service to dispose of the Drive system.

Vision

VISION NARROW FIELD

INDICATIONS AND CONTRAINDICATIONS FOR USE

BrightMatter™ Vision Narrow Field allows extracorporeal visualization of the operating field during diagnostic and treatment in surgery.

BrightMatter Vision Narrow Field is not an endoscope and must, therefore, only be used outside the body.

WARNINGS AND CAUTIONS

  • Failure to follow the instructions in the manual, and the instruction manuals of products used in combination with BrightMatter Vision Narrow Field, may result in injury to patients, users, and third parties, as well as damage to BrightMatter Vision Narrow Field.
  • Do not apply excessive force when assembling or disassembling BrightMatter Vision Narrow Field, especially in areas where threads are used for fastening
  • BrightMatter Vision Narrow Field is not sterile when delivered. The use of non-sterile instruments poses a risk of infection to patients, users, and third parties. Sterilize BrightMatter Vision Narrow Field before initial use, and before and after every subsequent use, using the sterilization procedures described in the manual.
  • Always assemble and disassemble BrightMatter Vision Narrow Field outside of the surgical field.
  • Never allow BrightMatter Vision Narrow Field to come into contact with electrified instruments.
  • Incorrectly assembled or damaged instruments can cause patient injury. Always check BrightMatter Vision Narrow Field, and any products used in combination with BrightMatter Vision Narrow Field, immediately before and after each use to ensure that they are complete, free from damage, in full working order, and have no unintentional raw surfaces, sharp corners, burred edges, or projecting parts. Inspect threaded parts for cross-threading damage. Be mindful of pinch hazards where parts join.
  • When assembling BrightMatter Vision Narrow Field, always tighten fasteners securely to prevent components from separating during a procedure.
  • Optical radiation poses a risk of injury to the eyes. Do not direct the illuminators at your own or the patient’s eyes.

VISION WIDE FIELD

INDICATIONS AND CONTRAINDICATIONS FOR USE

BrightMatter™ Vision Wide Field allows extracorporeal visualization of the operating field during diagnostic and treatment in surgery.

BrightMatter Vision Wide Field is not an endoscope and must, therefore, only be used outside the body.

WARNINGS AND CAUTIONS

  • Failure to follow the instructions in the manual, and the instruction manuals of products used in combination with BrightMatter Vision Wide Field, may result in injury to patients, users, and third parties, as well as damage to BrightMatter Vision Wide Field.
  • Do not apply excessive force when assembling or disassembling BrightMatter Vision Wide Field, especially in areas where threads are used for fastening.
  • BrightMatter Vision Wide Field is not sterile when delivered. The use of non-sterile instruments poses a risk of infection to patients, users, and third parties.
  • Sterilize BrightMatter Vision Wide Field before initial use, and before and after every subsequent use, using the sterilization procedures described in the manual.
  • Always assemble and disassemble BrightMatter Vision Wide Field outside of the surgical field.
  • Never allow BrightMatter Vision Wide Field to come into contact with electrified instruments.
  • Incorrectly assembled or damaged instruments can cause patient injury. Always check BrightMatter Vision Wide Field, and any products used in combination with BrightMatter Vision Wide Field, immediately before and after each use to ensure that they are complete, free from damage, in full working order, and have no unintentional raw surfaces, sharp corners, burred edges, or projecting parts. Inspect threaded parts for cross-threading damage. Be mindful of pinch hazards where parts join.
  • When assembling BrightMatter Vision Wide Field, always tighten fasteners securely to prevent components from separating during a procedure. Optical radiation poses a risk of injury to the eyes. Do not direct the illuminators at your own or the patient’s eyes.