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Brackmann II info sheet (.pdf format)

Brackmann II EMG System

	A Highly Sensitive EMG System for Otolaryngologists
	The Cost-effective Advantage in Cranial Motor Nerve Monitoring
	Sophisticated, Robust, and Easy-to-Use

The Brackmann II: A sensitive monitor/stimulator available at an affordable price

The updated, ultrasensitive Brackmann II EMG Monitoring System is both a stimulator and monitor. The stimulator uses precisely controlled low-energy pulses, allowing direct stimulation of cranial motor nerve tissue without injury. Using bipolar, hooked-wire electrodes, the monitoring system detects EMG activity that may occur due to manipulation, irrigation, or stimulation of the nerve. The activity is then amplified and broadcast as audible EMG signals, providing the surgeon with immediate audio feedback, as well as presented on a calibrated bar-graph display. EMG activity may be monitored over the entire length of a surgical procedure to evaluate nerve function. The Brackmann II EMG Monitoring System can monitor two muscle groups simultaneously, and additional monitoring capability can be obtained by stacking two or more units.

Features:

• Superior Electrocautery Suppression: The "Mute Sensitivity" feature provides an exceptional cable-free method of speaker muting.
• Improved Stimulator Artifact Suppression: Results in clearer EMG sound.
• Enhanced Super-High-Fidelity Audio with 20-watt Amplifier and High-quality Speaker: The system better allows the surgeon to clearly hear the ongoing EMG activity throughout the surgical procedure.
• 20-Element, Back-Lit Logarithmic Bar-Graph Display for Quick Assessment of Nerve Activity with Peak-Hold Indicator: Offers plenty of range and sensitivity for a variety of EMG events, and is backlit to be easy to read in a darkened operating room. Like the audio feedback system, the display provides immediate, distinct feedback to the surgeon. Peak-hold indicator allows time to see the most important EMG events.
• Integral Electrode Warning Circuit: An easy-to-use system that verifies the integrity of the monitoring electrodes.
• High-Precision, Low-Voltage, Constant Current Stimulator (Constant Current, 0.01 mA to 4 mA): Lower voltage means higher resolution and better precision when setting the voltage. In short, the Brackmann II reduces the risk of neural fatigue or injury.
• Bipolar Hooked-Wire Electrodes: Recommended by experts in the field.
• Convenient Stimulator and Monitor Pods: Lightweight and small, so each can easily be located near the operating table. Monitor Pod has Integral Cautery Detection System.
• Disposable Monopolar and Bipolar Stimulating Probes with Unique Flexi-tip Design: Available in both monopolar and bipolar styles in a variety of diameters.
• Battery Powered, Lightweight, and Portable: Allows continuous use, and is easily transported between operating rooms. Battery power eliminates shock hazard.
• "Quick Reference Card": Provides immediate answers about the Brackmann II's controls.
• Larger, More Robust Enclosure: Means units can be stacked for more channels or combined with other types of monitors.
• Updated Instructional Video and Operator's Manual: Both make learning how to use the system easy.

The Brackmann II provides straightforward, immediate, and easy-to-understand feedback of EMG activity:

The Brackmann II's features are specifically designed to facilitate simple operation. The system's elegant design foregoes high-cost, unnecessary features that can complicate and slow interpretation of EMG events. With the Brackmann II, the monitoring team gets immediate, essential information.
     Simple controls and clear displays provide immediate recognition of settings and output. The easy-to-read backlit LCD display allows the operator to easily see and adjust the stimulating current while in a darkened operating room. The small, convenient patient interface modules ("Monitor Pod" and "Stimulator Pod") can be easily located near the operating table. The "Monitor Pod" also has an integral cautery detection system.
     Additional innovations enhance the system's ease of operation. The unique, bipolar hooked-wire electrodes allow easy one-step insertion. Disposable monopolar and bipolar stimulating probes have a unique flexi-tip design, and are available in a variety of diameters. The removable, long-lasting battery packs with external quick-charge caddy allow for continuous use for an indefinite period.

Uses:

The Brackmann II EMG Monitor/Stimulator has been used successfully to monitor cranial nerves in many procedures, including the following:
    FACIAL NERVE
        - Otologic Surgery
            - Stapedectomy
            - Tympanoplasty
            - Tympanoplasty with mastoidectomy
            - Revision tympanoplasty mastoidectomy
        - Neuro-otologic Procedures
            - Acoustic neuroma excision
            - Translabyrinthine and retrolabyrinthine vestibular neurectomy
            - Glomus tumor resection
            - Placement of the auditory brain stem implant
            - Skull base procedures
            - Parotid Gland Surgery
    TRIGEMINAL NERVE (Motor)
        - Intracranial and skull base procedures
    GLOSSOPHARYNGEAL NERVE
        - Glomus tumor resection
        - Placement of the auditory brain stem implant
    SPINAL ACCESSORY NERVE
        - Skull base--jugular foramen procedures
        - Neck surgery
    HYPOGLOSSAL NERVE
        - Skull base--jugular foramen procedures
        - Neck surgery

Current Characteristics:

The Brackmann II EMG System uses pulsed, constant-current stimulation, which may be safer than constant-voltage or nonpulsed DC stimulators. The Brackmann II EMG Monitoring System allows direct stimulation of nerve tissue without injury. Special circuitry limits current to the preset level.

Sterilization Guidelines:

See the Operator's Manual for specific instructions.

Technical Specifications:

Stimulator

    - Current Output: 0 to 4 milliamperes
    - Pulse width: 0.0002 seconds
    - Pulse off time: 0.1998 seconds
    - Pulse Frequency: 0.2000 seconds
    - Output Display: 1-inch backlit LCD display (100-microampere resolution)

Monitor

    - Number of Channels: 2
    - Preamplifier Gain: 100 db.
    - Frequency Response: 100 to 1000 Hz.
    - Input Sensitivity: 10 microvolts
    - Output Display: 2 calibrated bar-graph displays (exponential); 3000 µVolt max.
    - Audio Output: 20-watt audio amplifier with 2-channel mixer
    - Batteries: 2.2 amp-hour, lead-acid (12 hours average life)

Other

    - Batteries: slide-in, lead-acid
    - Size: 12 x 4.5 x 11 inches (approx.)
    - Weight: 12 lbs. (including battery pack)

Warranty, Service, and Loaner Program:

The Brackmann II EMG Monitoring System is warranted to be free of defects in material and workmanship for a period of two years from purchase, except for probes and cables, which are warranted for 90 days. Batteries are covered under a separate warranty. Warranty is void if unit has been damaged by electrocautery. Because of the specialized circuitry and repair techniques, we recommend you return it to us for any repairs. Loaner instruments are available at a nominal charge plus shipping and insurance, and supplies used. Pack the instrument carefully and ship insured, via parcel post or UPS.

Furnished Accessories and Equipment Compatibility:

See current price list for latest selection. Additional accessories should be purchased for busy OR schedules. Compatible with the Silverstein Adapter for Continuous Stimulation (SACS). Please order separately.

Training and Technical Assistance:

To keep our prices low, only limited on-site in-services are provided. Please call WR Medical Electronics Company for a sales representative in your area. Use our toll-free hotline and the video included with the product for a pre-surgery review of how to use the product. Please call between 8:00 am and 4:30 pm Central Time.

30-day Approval Program:

Evaluation units are available for some products. Nominal rental fees apply. We encourage users to adopt new, more effective equipment that will provide better clinical and surgical results. Please contact WR Medical for more information.

CPT Codes for Monitoring:

Please e-mail for more information: ent@wrmed.com.  

Warnings and Cautions:

ELECTROCAUTERY

To avoid patient burns and damage to the unit, observe the Electrocautery Precautions located in the operator's manual. Never allow the electrocautery and stimulator probes to contact each other, and never simultaneously touch tissues or fluids in the surgical field.

OTHER WARNINGS AND CAUTIONS

• Do not attempt to repair the instrument. Call WR Medical Electronics Co. for servicing instructions.
• Do not steam sterilize the monitor pod or stimulator pod.
• Do check battery condition prior to and during use.
• Do recharge overnight before each use.
• Do not use in the presence of explosive gases. This unit is not explosion proof.

Quality and Safety Marks

• ISO 9001:2000, ISO 13485:1996, and MDD compliant
• See latest regulatory certifications