186-1037

BIS™ complete 2-channel monitoring system

Indications, Safety, and WarningsWarnings

Explosion hazard: Do not use the BIS™ Complete system in a flammable atmosphere or where concentrations of flammable anesthetics may occur.

Monitor is not designed for use in MRI environment.

Use only the power cord supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet.

United States requirement: For proper grounding, the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor.

If the integrity of the external protective earth ground is in doubt, the BIS™ Complete system shall be operated from its internal battery power source only.

Be sure the monitor is mounted securely in place to avoid personal or patient injury.

When connecting external equipment (e.g., data capture computer), the system leakage current must be checked and must be less than the IEC 606011-1 limit.

The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

Use of the accessory in the patient's vicinity.
Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
Due to elevated surface temperature, do not place BISx™ in prolonged direct contact with patient’s skin, as it may cause discomfort.
The conductive parts of electrodes or sensor and connectors should not contact other conductive parts, including earth.
To reduce the hazard of burns during use of high-frequency surgical equipment, the sensor or electrodes should not be located between the surgical site and the electro-surgical unit return electrode.
To reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical motor evoked potential), place stimulating electrodes as far as possible from the BIS™ sensor and make certain that sensor is placed according to package instructions. The sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BIS™ Complete system.
To minimize the risk of patient strangulation, the patient interface cable must be carefully placed and secured.
Shock hazard: Do not attempt to disconnect the power cord with wet hands. Make certain that your hands are clean and dry before touching the power cord.
Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Place contaminated materials in regulated waste container.
Do not mix disinfecting solutions (e.g., bleach and ammonia), as hazardous gases may result.
Electrical shock hazard: Do not remove monitor covers during operation or while power is connected to monitor.
Electrical shock hazard: The manufacturer's inspection of this apparatus verified that the ground leakage current and the patient safety current were less than the specified limits established by the applicable safety standards. As a matter of safe practice, the institution should conduct periodic tests to verify these currents.
Whenever an event such as spillage of blood or solutions occurs, re-test ground leakage current before further use.
Leakage current must be checked by a qualified biomedical engineering technician whenever instrument case is opened.
Power supply is internally fused. Replace power supply only with Medtronic BIS™ Complete power supply.

Cautions

Read this entire manual carefully before using the monitor in a clinical setting. Do not autoclave the BISx™ or monitor. Autoclaving will seriously damage both components.

Do not block ventilation inlet holes on the underside of monitor.

Do not open BISx™ for any reason. The seal to prevent liquids from entering the BISx™ may be damaged if opened.

Service or repairs must be performed only by qualified biomedical technicians.

The BIS™ Complete system has been designed to operate with a BIS™ sensor. The sensor is a silver/silver chloride electrode array that uses Zipprep™ technology and uses a proprietary connector. Use of other electrodes is not recommended.

To completely remove power from the unit, put the monitor in standby mode, disconnect power cord from the power receptacle of the monitor, then remove the battery from the monitor.

Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance check signal interferes with other equipment (e.g., evoked potential monitors).

Considerations when using electro-convulsive therapy (ECT) equipment during BIS™ monitoring:

Place ECT electrodes as far as possible from the BIS™ sensor to minimize the effect of interference.

Certain ECT equipment may interfere with the proper function of the BIS™ monitoring system.

Check for compatibility of equipment during patient setup.

Check the battery periodically by operating a BIS™ Complete monitor that has been disconnected from the wall socket and that has been charged to full capacity (at least six hours of charge time). After long periods of storage, charge the battery for six hours to assure full capacity. If the BIS™ Complete monitor fails to operate reliably from the battery for approximately 45 minutes, battery replacement is required.

The BIS™ Complete monitor contains an internal lithium ion battery. The battery must be removed by a qualified service technician and disposed of or recycled in accordance with the national laws of the country.

Avoid liquid ingress to the patient interface cable. Contact of fluids with the PIC (patient interface cable) sensor connector can interfere with PIC performance. Service or repairs must be performed only by qualified biomedical technicians.

The BIS™ Complete system complies with the electromagnetic compatibility requirements of IEC 60601-1-2. Operation of this device may affect or be affected by other equipment in the vicinity due to electromagnetic interference (EMI). If this occurs:

Increase separation between devices.
Re-orient device cabling.
Plug devices into separate outlet circuit branches.
Reference electromagnetic compatibility specifications, page B-4.

Do not disconnect the BISx™ during the software update.

When connecting or disconnecting BISx™, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result.

Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS™ Complete monitoring system.

The BIS™ Complete monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BIS™ Complete monitor should be observed to verify normal operation in the configuration in which it will be used. Important: The BIS™ Complete systems comply with the European Medical Device Directive (MDD) and applicable regulatory requirements of the country distributed to and carry the CEXXXX marking. Declarations of Conformity are provided upon request where appropriate.

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