Safety Concerns, Electric shock hazard protection

4.2. Safety Concerns

Electric shock hazard protection

OMRON M24/7 monitors meet relevant shock hazard protection standards. OMRON M24/7 monitors operate with two 1.5V AA batteries or two 1.2V AA rechargeable batteries. This excludes all electric shock hazards, even in the unlikely case of multiple device errors. Use only standard long-life (alkaline) batteries, or standard NiCd or NiMH rechargeable batteries of the proper size. Do not use lithium batteries. Do not mix different battery types, do not mix new and old batteries, do not use damaged batteries.

Many personal computers do not meet certain shock hazard protection standards or strict safety regulations applicable to medical devices. Therefore, during the computer-based use of OMRON monitors, keep at least a 2 meter distance between patient and computer. This is the required minimum safety distance. OMRON M24/7 monitors communicate using a plastic optical cable, whose 4 m standard length allows for the required safety distance. The plastic optical cable ensures perfect electric separation and reduces the effects of external electric noise. It does not conduct electricity.

Biocompatibility

To avoid infection risks, and for general hygienic reasons, the device, cuff and tubing should never contact the patient’s skin directly.

Hazardous materials

Used batteries qualify as hazardous waste and should be disposed of properly. OMRON monitors do not contain any materials quali ed as pharmaceutical substance or tissue of animal origin. They emit no material hazardous to humans.

Risk of incorrect diagnosis

The basic intended use of OMRON M24/7 monitors is to record blood pressure and pulse rate values. Patients should be informed about rules of cooperative behaviour; proper handling of the monitor used, and expected results of monitoring in advance. OMRON M24/7 monitors only provide data to support diagnostic decisions of a quali ed physician; they do not automatically provide a diagnosis of any kind. During the evaluation of recorded blood pressure values, possible artefacts due to external disturbances, motion artefacts, and electrical noise should be observed and handled with caution.