PMAC71DOC

Indications, Safety, and WarningsIndicationsThe INVOS™ 7100 Regional oximeter patient monitor is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals > 2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤ 2.5kg, the INVOS™ patient monitor is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual.Explosion, shock, and toxicity hazards

Explosion hazard — Do not use the monitoring system in the presence of flammable anesthetics.

Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See the accessories/parts list in the monitoring system’s operator’s manual.

Shock hazard — Ensure the monitoring system is properly grounded when operating on AC power.

Shock hazard — Device must only be connected to a supply main with protective earth.

Shock hazard — When connecting the monitoring system to any instrument, verify proper operation before clinical use. Any equipment connected to the data interface must be certified according to the latest IEC/EN 60950-1 standard for data-processing equipment, the latest IEC/EN 60601-1 or ANSI/AAMI ES60601-1 (U.S.) standard for electromedical equipment, or the latest IEC/EN or ANSI/AAMI (U.S.) safety standards relevant to that equipment. All combinations of equipment must be in compliance with Requirements for Medical Electrical Systems within IEC/EN Standard 60601-1 or ANSI/AAMI ES60601-1 (U.S.). Anyone who connects equipment to the data interface is configuring a medical system and, therefore, is responsible for ensuring the system complies with the Requirements for Medical Electrical Systems IEC/EN Standard 60601-1 or ANSI/AAMI ES60601-1 (U.S.) and the electromagnetic compatibility IEC/EN Standard 60601-1-2. Performance may degrade if it is connected to secondary I/O devices when the equipment is not connected to earth reference.

Toxicity hazard — The LCD panel (screen) contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances.

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Patient monitoring and safety

Always disconnect and remove the monitoring system and sensors during magnetic resonance imaging (MRI) scanning. Attempting to use the monitoring system during an MRI procedure could cause burns or adversely affect the MRI image or the monitoring system’s performance.

Do not set alarm limits to extreme values that render the monitoring system ineffective. Ensure alarm limits are appropriate for each patient.

Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

An external multi-parameter system will not generate an alarm or error message if remote communication between the multi-parameter system and the monitoring system has been broken. During this period of no remote communication, the monitoring system will continue to monitor, generate alarms, and display status messages. The multi-parameter system operator should not rely on the multi-parameter system for generating alarms.

Choking hazard — The reusable sensor cables (RSCs) include a strain-relief clip that, if detached, may pose a choking hazard.

Caution: If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.

Note: The components of the PM7100 monitor that are connected to protective earth are contained within the external power supply and are not accessible to the user. Exposed metal parts on the monitor are double insulated from live parts. A ground continuity test should not be performed; doing so may damage the equipment and void the warranty.

The monitoring system should not be used as the sole basis for diagnosis or therapy. It is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Operation

Inspect the monitoring system and all accessories before use to ensure there are no signs of physical damage or improper function. Do not use if damaged.

If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative.

To ensure proper performance, avoid shock, and prevent device damage or failure, do not expose the monitoring system to extreme moisture, such as direct exposure to rain. Do not immerse in water, solvents, or cleaning solutions, since the monitoring system and connectors are not waterproof.

Dispose of the battery in accordance with local guidelines and regulations.

Sensors, cables, and other accessories

The use of accessories, sensors, and cables other than those specified may result in poor performance of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system.

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

Failure to cover the sensor site with opaque material when operating under high ambient light conditions may result in poor performance.

Electromagnetic interference

Electromagnetic emissions from the monitoring system may interfere with other critical devices.

Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the monitoring system, including cables. Otherwise, degradation of monitoring system performance may result.

The monitoring system is intended for use by healthcare professionals only. It may cause radio interference or may disrupt the operation of nearby equipment. Mitigation for such disruption may require re-orienting or relocating the monitoring system or shielding the location.

Any radio frequency transmitting equipment or other nearby sources of electrical noise may result in disruption of the monitoring system.

The monitoring system is designed for use in environments in which the signal can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate, or the monitoring system may not seem to operate correctly.

EMI disruption can cause cessation of operation or other incorrect functioning.

The monitoring system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the monitoring system to verify normal operation in the desired configuration. Technical alarms may indicate that the configuration is not appropriate for the monitoring system.

This device has been tested and found to comply with the limits for medical devices related to IEC 60601-1-2: 2007 and IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

When operating medical electrical equipment, special precautions related to electromagnetic compatibility (EMC) are required. Install the monitoring system according to the EMC information included in this manual.

The monitoring system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. If interference is suspected, move monitoring system cables away from the susceptible device.

The use of an electrosurgical or electrocautery instrument in the vicinity of the monitoring system may interfere with the signal and cause poor performance or no readings at all.

Cleaning

Do not autoclave or gas sterilize any components of the monitoring system.

To prevent device damage or failure, do not expose the monitor to isopropyl alcohol.

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