Comen CM300 - Chapter 5 Performance Verification; 5.1 Safety Test; 5.2 Performance Tests

Shenzhen Comen Medical Instruments co., ltd.
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ECG disturbance
Identical electrode had no reliable
linked with patient body;
re-install the electrode or paste some
water or conductive ointment at the
contact position
ECG machine, electrode, metal bed
or lead cable reliably connected with
grounding
Check ECG machine, electrode, metal bed
or lead cable reliably connected with
grounding
Disturb by electric equipments of
large power wor 的 king nearby
Check if there is disturb by electric
equipments of large power working nearby
Electrode and skin pasted with
sufficient conductive ointment.
Switch on the ECG filtering function of the
machine
The patient wearing jewelry such as
glasses or gems, AC disturbance can
not be cleared.
Switch on the ECG filtering function of the
machine
4.5.7 Electromyograhic disturbance
Symptoms
Possible Cause
Correction Action
Electromyograhic
disturbance
Communication disturbance
Switch on the shift filtering function of the
machine to 25Hz or 35Hz, and then the
recorded ECG waveforms will reduce a
little bit.
The doctor talk to the patient
during ECG recording process
The Electrode clippers on the
arms and legs too tightened
4.5.8 Unstable baseline
Symptoms
Possible Cause
Correction Action
Unstable baseline
electrode installation stable, lead
cable and electrode connected
properly
Switch on the shifting filtering function of
the machine to 0.1Hz, 0,2Hz or 0.5Hz, the
recorded ECG waveforms will reduce a
little bit.
electrode and patient skin clean
electrode and skin pasted with
sufficient conductive ointment