MR8-DS1TD32

Stealth Autoguide™ robotic guidance system

Indications, Safety, and WarningsThe Stealth Autoguide™ system is a remotely-operated positioning and guidance system indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).Residual risksResidual risks related to the use of a Medtronic computer-assisted surgery system and its associated applications are the same as the residual risks for the procedures in which the system is used.ContraindicationsMedical conditions that contraindicate the use of a computer-assisted neurosurgery system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.Warnings

The system may only be used by medical professionals.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

The power cord may not be extended by an extension cord since this increases the resistance of the protective earth and may result in electric shock. For the United States and other countries with dedicated medical grade power outlets, the connection of the system is only allowed to a power outlet that provides a protective earth connection marked as “medical grade” or “hospital grade.”

Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

To avoid the risk of electrical shock, this equipment must only be connected to the supply mains with protective earth.

Be aware of risks when using high frequency electrosurgery devices, such as monopolar or bipolar needles or forceps, together with the system. Hazardous voltage may be induced to the system. There is a risk of electrical shock or thermal injuries.

Do not use high-frequency electrosurgery devices, such as monopolar or bipolar needles or forceps, with maximum output voltages higher than 6 kV (peak-to-peak) together with the system. Hazardous voltage may be induced in the system. There is a risk of electrical arcs, electrical shocks, or thermal injuries.

Avoid the following situations because they may compromise the integrity and efficacy of the Autoguide™ sterile drapes:

Rough handling, such as extreme pull and push forces or binding with moving parts
Touching unsterile surfaces with the drape
Close proximity of sharp instruments to the drape

System status information may not be available on the Autoguide™ control unit due to a display failure. In this case, consult the StealthStation™ system display for current trajectory alignment information and the illuminated symbols on the Autoguide™ targeting unit to understand if any system error exists. Failure to follow these instructions may result in a risk of patient injury or a compromised surgical procedure.

The use of instrumentation, interfaces, and sterile drapes other than stated compatible instruments, interfacing devices, and sterile drapes may lead to loss of accuracy, patient injury, or both.

The use of system components beyond their useful life may lead to patient injury.

The repair or modification of system components or surgical instruments by anyone other than qualified service personnel may compromise the product’s ability to perform effectively and void the equipment warranty.

Reusable devices are designed for reuse and are supplied in non-sterile condition. Clean and sterilize devices before every use in accordance with specified instructions.

Connecting the system to non-approved information technology (IT) networks and other equipment can result in previously unidentified risks to patients, operators, or third parties. The system must only be connected to a StealthStation™ system. Log files within the system will be maintained to verify proper setup. The responsibility for the identification, analysis, evaluation, and control of risks associated with connecting the system to a non-approved IT network resides with the individuals performing the connection.

Changes to the IT network can introduce new risks to the product that require additional analysis. These changes encompass changes in network configuration, connection of additional items, disconnection of items, update of equipment, or upgrade of equipment. Log files within the system will be maintained to verify proper setup. Individuals implementing changes on the IT network are responsible for the identification, analysis, evaluation, and control of risks associated with the changes.

Precautions

Federal law (United States) restricts this device to sale by or on the order of a physician.

Exceeding the maximum length of any cables may impact the electromagnetic performance and compliance (immunity or emission) of the system.

The network connection to the StealthStation™ system must only be established directly, without the use of any hub, switch, router, or equivalent device, to avoid any impairment of performance.

Portable radiofrequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Stealth Autoguide™ system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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United States

Customer Care Team