Important Patient and Safety Information
ST80i Stress Test System Instructions for Use vii
– taking care when dressing the ECG cables so as to minimize the potential tripping
hazard during the stress ECG study process
– securing the patient lead set, power cable, treadmill cable, echo cable, NIBP cable,
and SpO2 cable away from patient’s feet before beginning exercise stage
The ST80i captures and presents data reflecting a patient’s physiological condition that,
when reviewed by a trained physician or clinician, can be useful in determining a
diagnosis. However, the data should not be used as a sole means for determining a
patient’s diagnosis.
Both analog ECG output and TTL sync output are not in real time: there is a delay
between the patient’s physiological activity and the appearance of its representative signal
at the external port. This signal should not be used for analysis.
To get the most accurate interpretation during resting ECG, use traditional limb lead
placement.
For the user’s convenience only, rhythm change notifications are provided when specific
rhythm changes are detected; however, it is the responsibility of the trained healthcare
professional to determine the type of rhythm change and take appropriate action.
Additionally, the healthcare professional should not assume that all rhythm changes will
be detected, and they are responsible for taking action when rhythm changes are observed
on the displayed waveforms and the system fails to provide a notification. It is expected
that only properly trained healthcare professionals working directly under the supervision
of a qualified physician will be operating the ST80i System during testing.
ST80i cannot import ECGs from another vendor’s stress system.
“Simulated ECG” mode must be turned off when testing patients.
If the “Stop Treadmill” GUI button does not respond for any reason, immediately press the
red “Emergency” button on the treadmill handrail.
The interpretive algorithm has been validated only with “standard” lead placement.
If the patient data is found to be incorrect, you may edit the ECG file and can print a new
report.
Entering incorrect NIBP data can cause errors for NIBP-related parameters in reports.
Caution Statements for the ST80i System
CAUTION Caution statements describe conditions or actions that may result in damage to equipment or
software.
The Multiple Portable Socket-Outlet (MPSO) provided with the system shall only be used
for powering equipment which forms part of the system.
Do not pull or stretch patient lead wires as this could result in mechanical and/or electrical
failures. Store patient lead wires after forming them into a loose loop.
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