Important Patient and Safety Information
ST80i Stress Test System Instructions for Use v
To maintain designed operator and patient safety when assembling a medical electrical
system for use in the patient environment, the responsible organization shall ensure that
peripheral equipment and accessories used that can come in direct patient contact must
comply with the following standards:
– IEC 60601-1-1:2000 aka CAN/CSA-C22.2 No.60601-1-1:02
– EN 60601-1-2:2001 (all parts and particularly clause 19), titled, “Medical electrical
equipment - Part 1-1: General requirements for safety - Collateral Standard: Safety
requirements for medical electrical systems”
– EN 60601-1:2006 (clause 16 and particularly clause 16.6), titled, “Medical electrical
equipment - Part 1: General requirements for basic safety and essential performance”
Connecting multiple medical electrical instruments to the same patient may pose a safety
hazard due to the summation of leakage currents. Any combination of medical electrical
instruments should be evaluated by local safety personnel before being put into service.
For equipment not certified to medical electrical equipment standards that may be used
within the patient vicinity, an appropriately rated isolation transformer is required.
Do not connect to the system any items which are not specified as part of the system.
The PC, LCD, thermal printer, and desk light, purchased as part of a complete system
must be plugged into the medical-grade isolation transformer provided with ST80i.
Plug all accessories used with ST80i into the medical-grade isolation transformer
provided as part of the “software-only” solution.
Do not connect additional Multiple Portable Socket-Outlets (MPSOs) or extension cords
to the system.
The ST80i USB and RS-232 ports should be connected only to treadmills, ergometers, and
NIBP monitors that are certified to meet IEC 60601-1 and are listed as supported devices
in the Instructions for Use. See See “Supported Treadmills and Ergometers” on page 7. of
Appendix E, “Specifications and Requirements”.
The performance and safety of the ST80i System cannot be guaranteed if you use
non-compatible accessories.
Only computers, monitors, and printers approved by a National Certification Body (NCB)
or a Nationally Recognized Testing Laboratory (NRTL) to IEC 60950-1 shall be
connected to the ST80i system. All computer, monitor and printer outputs shall comply
with IEC 60950-1 limited power source requirements.
The use of ST80i with equipment (electrosurgical equipment and some respiration
transducers) that applies high frequency voltage to a patient is not supported and may
produce undesired outputs.
To prevent burns to the patient, remove all ECG electrodes and lead wires prior to the use
of high frequency surgical equipment (including electrosurgical equipment and some
respiration transducers).
Only install Philips software on the ST80i System. The installation or use of software,
security patches, or updates not approved by Philips is strictly prohibited and system
safety and performance are not guaranteed.
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