11. Safety Concerns
a. Electric shock hazard protection
The ABP-01 monitor meets the relevant shock hazard protection standards. The device operates with two 1.5V AA
batteries or two 1.2V AA rechargeable batteries, which excludes all electric shock hazards, even in the unlikely case
of multiple device errors.
Many personal computers do not meet shock hazard protection standards or strict safety regulations applicable to
medical devices. Therefore, during the computer-based use of the recorder, keep at least a 2 meter distance between
the patient and the computer. This is the required minimum safety distance. ABP-01 communicates via a plastic
optical cable, the 3 m standard length of which 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.
b. Hazardous materials
Used batteries qualify as hazardous waste and should be disposed with care. The recorder does not contain any
materials qualified as pharmaceutical substance or tissue of animal origin. They emit no material hazardous to
humans.
c. Risk of incorrect diagnosis
The basic intended use of the monitor is to record blood pressure and pulse rate values. Patients should be informed
about rules of cooperative behavior; proper handling of the monitor, and expected results of monitoring in advance.
The monitors only provide data to support diagnostic decisions of a qualified 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.
See chapter Cuffs for more information!
12. Cleaning & Protection
The ambulatory blood pressure monitor is not specially protected against spills or ingression of water or other liquids.
Cleaning the monitor
A recommended means of cleaning is to wipe the recorder with a disinfectant cleaning tissue. Alternatively, wipe
with a slightly damp cloth then dry it with an antistatic tissue. Do not expose monitors to extreme heat or radiation,
including long exposure to direct strong sunlight.
To clean the PU leather fabric cuff, please do the following:
Wipe the cuff with a damped cloth or detergent/disinfectant tissue (e.g.: ethanol 70%, isopropyl-alcohol 70%,
microzid). The bladder cannot be removed!
NOTE: Avoid any leakage into the tube while cleaning the cuff. (Plug the end of the tube.)
Don’t take the unit into a sterilizing machine!
Don’t use bleach!
Protection
Do not immerse the monitor in water or any cleaning fluid and protect it from spills and splashes. Do not expose it to
heavy rain or steam and do not wear it in a wet environment e.g.: shower, bath or swimming pool. In case of minor
effects of wet environment, wipe off water drops with a dry cloth. Keep the monitor in a normal dry room for at least
one hour before use if condensation is suspected.
In case of ingress of water in the monitor, remove batteries from the unit, and refer the unit to authorized service.
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