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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.
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