Medical Device Manual PDF
Medical Device Manual PDF
1. Intended Use
The intended use of the cardiograph is to acquire multi-channel ECG signals from adult
patients from body surface ECG electrodes and to record, display, analyze, and store these
ECG signals for review by the user. The cardiograph is to be used in healthcare facilities by
trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms
that provide measurements, data presentations, graphical presentations, and interpretations
for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician
on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the
patient, the results of the physical examination, the ECG tracings, and other clinical findings.
A qualified physician is asked to overread and validate (or change) the computer-generated
ECG interpretation.
1 2 3 4 5 6 7
I V1
II V2
III V3
aVR V4
aVL V5
aVF V6
8 13 9 10 12 11
Caution: If in doubt the integrity of the AC power source, the device must be
operated from its internal battery.
MeCA812i can be operated with normal power source. Input voltage range of power is 100-
240VAC, and input frequency is 50/60Hz. Power cord connector is situated at the rear side.
AC Power Input
1) Connect the female connector end of the AC power cable to the device’s rear panel mains
connector.
2) Plug the male connector end of the AC power cord into a properly grounded mains outlet.
3) If necessary, connect grounding wire. Connect the grounding wire connector to the
equipotential terminal on the rear panel. Now attach the clip end of the grounding wire to the
medical equipment grounding terminal on the wall.
2) Battery status
If battery power is deficient, the battery capacity short warning “Low Battery” is displayed on
the screen. A warning message “Low Battery” appears and beep sounds before the device
shuts off. After that, the device automatically shut down. When warning message “Low
Battery” appears, all keys are not operation. Connect the device to an AC power source to avid
any loss of trends or setting.
Table 3-3 Battery Charging Status Indications
Battery conditions Battery charging status indicator( )
Full charged On
Charging Flashing
Battery Operation Off
NOTE: Even if the device is turned off, Battery indicator ( ) flashes while the
battery is recharged.
NOTE: A fully charge of a depleted battery takes approximately 6 hours while the
device is turned on/off.
Warning: When warning message “Low Battery” appears and beep sounds,
connect the device to AC Power Source. If AC power source is not connected
in low-battery condition, do not operate the File Management, Firmware
Upgrade, System Setup (Default setting) and External Interface because the
data can be lost and the device can be made an error.
Warning: Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a qualified service engineer.