User manual

13
8. Safety concerns
Electric shock hazard protection
Each ABPM recorder meets the relevant shock hazard protection standards. ABPM-05 and
BlueBP-05 operates with two 1.5V AA batteries or two 1.2V AA rechargeable batteries,
while ABPM-04 uses four 1.5V AA batteries or four 1.2V rechargeable batteries. This
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
Meditech recorders, keep at least a 2 meter distance between the patient and the computer.
This is the required minimum safety distance. ABPM-05 and ABPM-04 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. BlueBP-05 recorders communicate via
radiofrequency transmission (Bluetooth). This ensures the perfect electronic seperation from
the PC.
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 with care. Meditech
recorders do not contain any materials qualified as pharmaceutical substance or tissue of
animal origin. They emit no material hazardous to humans.
Risk of incorrect diagnosis
The basic intended use of Meditech recorders is to record blood pressure and pulse rate
values. Patients should be informed about rules of cooperative behaviour, proper handling of
the recorder used, and expected results of monitoring in advance. The recorders 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.
9. The use of the monitors
The recorders can be programmed by CardioVisions software installed on a personal
computer. Once the preprogrammed time is reached, the recorder starts operating
automatically by taking blood pressure measurements according to the monitoring plan.
Connecting the recorders to the PC
You can connect Meditech recorders depending on the recorder type to your computer in
several ways. ABPM-05 and ABPM-04 are equipped with a connector slot for a special
optoelectronic communication cable – with these recorders, the computer-end of the
interface cable has to be properly plugged into a corresponding socket on the computer
before inserting its small recorder-end plug into the socket on the recorder for
communication between the CardioVisions software and the recorder.