PM1000N-RR

Indications, Safety, and WarningsWarnings

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

Explosion hazard: Do not use the battery with other manufacturer’s batteries. Do not use different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or lithium-ion batteries together.

Do not use any monitoring system or pulse oximetry cables, sensors, or connectors that appear damaged.

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not simultaneously touch the patient and the signal input, signal output, or any other connectors.

Do not lift or carry the monitoring system by the pulse oximetry sensor or pulse oximetry interface cable. The cable may disconnect and cause the monitoring system to drop on a patient or cause damage to monitoring system surfaces.

To ensure patient safety, do not place the monitoring system in any location where it might drop on the patient.

The LCD panel 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.

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 accuracy.

The monitoring system is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

The values displayed by the monitoring system can be affected by patient conditions, excessive patient movement, sensors, environmental conditions, and nearby external electromagnetic conditions.

The monitoring system is intended for use in a hospital or hospital-type environment by trained medical personnel.

Failure to cover the pulse oximetry sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. Refer to the appropriate sections of this manual for specific safety information.

The monitoring system is not defibrillator-proof. It may remain attached to the patient during defibrillation or during use of an electrosurgical unit; readings may be inaccurate during defibrillation and shortly thereafter.

The monitoring system may retain trend data from multiple patients if transferring the monitoring system from one patient to another.

Any connections between this monitoring system and other devices must comply with applicable medical systems safety standards such as IEC 60601-1. Failure to do so could result in unsafe leakage current and grounding conditions.

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

Do not preset different alarm limits for the same or similar equipment within a single area.

Cautions

The monitoring system may not operate properly if it is operated or stored in conditions outside the ranges stated in this manual, or if it is subjected to excessive shock or dropping.

Do not spray, pour, or spill any liquid on the monitoring system, its accessories, connectors, switches, or openings in the chassis, since this may cause damage to the monitoring system. Never place fluids on the monitoring system. If fluid spills on the monitoring system, remove batteries, wipe dry immediately, and have it serviced to ensure no hazard exists.

Accessory equipment connected to the monitoring system’s data interface must be certified according to IEC 60950-1 for data-processing equipment. All combinations of equipment must be in compliance with IEC 60601-1 Requirements for Medical Electrical Systems. Anyone who connects additional equipment to the signal input or signal output port configures a medical system and is therefore responsible for ensuring the system complies with the requirements of IEC 60601-1, IEC 60601-1-2:2007, and IEC 60601-1-2:2014.

When connecting the monitoring system to any instrument, verify proper operation before clinical use. Both the monitoring system and the instrument connected to it must be connected to a grounded outlet.

For best product performance and measurement accuracy, use only accessories supplied or recommended by Medronic. Use accessories according to the manufacturer’s instructions for use and institutional standards. Use only accessories that have passed the recommended biocompatibility testing in compliance with ISO10993-1.

Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, the monitoring system operates from its battery.

This 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.

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.

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