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Safety
Precautions for Using the Equipment
Precautions about the ST Measurement
The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment
changes need to be determined by a clinician.
For the lead which the electrode is detached, the reference waveform setup cannot be performed. Check if the
electrode is appropriately attached, and perform the setup again.
Precautions about the 12-Lead Analysis
Interpretation and Minnesota codes given by this equipment do not instruct the physician as to the kind and
degree of cardiac disease. Accordingly, four value judgments are given for ECG waveform and although
"abnormal" indicates a large possibility of organic cardiac disease, there are cases where no cardiac disease
exists despite an abnormal ECG (that is, an abnormal ECG may be caused by something other than heart).
On the other hand, care should be taken in the event any preclinical coronary arteriosclerosis could be present
despite a normal ECG interpretation.
Therefore, for a proper diagnosis, the ECG should be integrated with other interpretations.
ECG Recording by the Mason-Likar System
The 12-lead ECG recorded with the torso placement of the limb leads (Mason-Likar 12-lead system) may differ
from the standard 12-lead ECG. Moreover, waveforms may differ somewhat also in a supine position and a
standing position (sitting position).
Fukuda Denshi recommends to carry out the recording of the ECG by taking into consideration the waveform
differences according to electrode positions or postures.
For the model installed with ECG analysis program
The ECG analysis program is intended to analyze the standard 12-lead ECG waveforms. Therefore, the
analyzed result for waveforms recorded with the torso placement of the limb leads (Mason-Likar 12-lead
system) may differ from that of the standard 12-lead ECG waveforms.
Select "Used" for the pacemaker setting on the patient admit/discharge menu if a patient has a pacemaker.
The threshold values for classification of 12-lead ECG interpretation and Minnesota code are set by age and
sex as follows:
1. Male and Female of ages 19 years old and above
2. Male of age 12 through 18 years old
3. Female of age 12 through 18 years old
4. Male and Female of ages 3 through 11 years old
5. Male and Female of ages below 2 years old
If no patient information (i.e. Default : "Class." [Adult], "Sex": undetermined, and "Age" [0]) has been entered,
the system algorithm will handle the patient as a "35 years old male".
Before the analysis, make sure the patient classification ([Adult] / [Child]) is properly selected. If [Neonate] is
selected, the 12-lead ECG analysis will not function.
Enter the age of patient if known. If no age information (i.e. Default: [0]) has been entered, the system
algorithm will handle the patient as "35 years old".
Enter the sex of patient if known. If no sex information (i.e. Default: undetermined) has been entered, the
system algorithm will handle the patient as "Male".
If the patient classification is set as [Child] and no age (i.e. Default: [0] ) has been entered, the system algorithm
will handle the patient as "less than 2 years old""
Precautions about the SpO
2
Monitoring
Use only the sensor/relay cable specified by Fukuda Denshi. Otherwise, it may cause measurement error.If
the sensor is damaged, stop using it.
If the nail is rough, dirty, or manicured, accurate measurement will not be possible. Change the finger or clean
the nail before attaching the sensor.
If irritation such as skin reddening appears with the sensor use, change the attachment site or stop using the
sensor.
Do not apply the sensor too tight. At the same time, check the blood flow constantly so that congestion is not
CAUTION
CAUTION
CAUTION
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