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Medical Device Manual PDF

The document provides instructions for using a cardiograph device called the MeCA812i. It states that the device is intended to acquire and analyze ECG signals from patients and provide interpretations to assist clinicians. The instructions explain how to connect the device to power, describe the battery status indicators, and provide various cautions and warnings regarding use of the device.

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Franklin Ukaegbu
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0% found this document useful (0 votes)
126 views4 pages

Medical Device Manual PDF

The document provides instructions for using a cardiograph device called the MeCA812i. It states that the device is intended to acquire and analyze ECG signals from patients and provide interpretations to assist clinicians. The instructions explain how to connect the device to power, describe the battery status indicators, and provide various cautions and warnings regarding use of the device.

Uploaded by

Franklin Ukaegbu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Introduction

Caution: Medical technical equipment such as the MeCA812i must only be


used by qualified and trained personnel.

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.

18 MeCA812i Operator’s Manual


Introduction

Table 2-1. Display Description


Graphic LCD

1 2 3 4 5 6 7

10mm/mV 25mm/s 0.16Hz 100Hz 40Hz EMG Automatic

I V1

II V2

III V3

aVR V4

aVL V5

aVF V6

28/02/2007 AFS I II III 3 * 3R SD HR 060

8 13 9 10 12 11

No. Item Description


1 Gain Gain indication of ECG signal

2 Speed Writer speed indication of ECG signal

3 High Pass Filter High pass filter

4 AC Line Filter Elimination of AC line interference

5 Low Pass Filter Low pass filter

6 Muscle Filter Elimination of muscle artifact (only automatic mode)

7 Measurement Mode Indication of measurement mode

8 Date, Time Date and Time indication

- Manual Mode: Lead combination indication


9 Lead
- Auto Mode: Rhythm Lead indication

10 Report Format Indication of report format

11 Heart Rate Indication of heart rate

12 SD card Indication of SD card

13 Anti Floating System Indication of AFS

20 MeCA812i Operator’s Manual


Putting the device

2. Power Cable Connection


Warning: Do not use multiple portable socket outlets to connect the device to
the power line.

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

Figure 3-1. 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.

MeCA812i Operator’s Manual 29


Putting the device

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.

Caution: For environmental protection, please discard the worn accessories at


the designated area in accordance with proper protocol.

Caution: It is recommended to use the equipment at the environment where AC


rated power is provided, and it is required to use the charging battery power
source during emergency situation or during inevitable movement. On the
other hand, when using battery, charge it for at least 6 hours and then use it.

MeCA812i Operator’s Manual 31

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