Safety Summary
xii ST80i Stress Test System Instructions for Use
Warnings about the Wireless Patient Interface Module
WARNING Failure to follow these warnings could affect both patient and operator safety.
The wireless patient interface module transmits data reflecting a patient’s physiological
condition to a properly equipped system and 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.
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”
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.
FCC Warning: Changes or modifications not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
To avoid the possibility of serious injury or death during patient defibrillation, do not
come into contact with device or lead sets. Additionally, proper placement of defibrillator
paddles in relation to the electrodes is required to minimize harm to the patient.
Defibrillation protection is guaranteed only if the original lead set is used.
Ensure that the electrodes or lead wires do not come in contact with any other conductive
materials (including earth-grounded materials), especially when connecting or
disconnecting electrodes to or from a patient.
If your facility is using more than one PIM, each one must be added to the ST80i
application under Settings (System Settings; I/O Devices). When you connect the patient
to one of the PIM devices, you also need to verify the address on the device with the
address that shows up on the Pre Exercise screen.
A possible explosion hazard exists. Do not use the device in the presence of flammable
anesthetics, or flammable mixtures with air, oxygen, or nitrous oxide.
Some stimulators may cause interference with the signal.
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