Safety Summary
viii ST80i Stress Test System Instructions for Use
Do not attempt to clean the device or patient lead wires by submersion, autoclaving, or
steam cleaning.
Wipe the exterior surface of the device and patient lead wires with a compatible non-
alcohol sterilizing disinfectant, then dry with a clean cloth. See “Cleaning the ST80i
System” on page 5-2 in the “Maintaining the ST80i System” chapter for a list of approved
disenfectants.
Be careful not to damage the display when moving the trolley or when moving other
equipment near trolley.
To prevent possible damage to the device during transport and storage (while in original
packaging), the following environmental conditions must be adhered to:
Storage Temperature Range:
-20°C to 50°C (-4°F to 122°F)
Storage Humidity Range:
10% to 90% (non-condensing)
Storage Pressure (altitude):
Up to 4,572 m (15,000 ft.) altitude
Allow the device to stabilize within its intended operating environment for a minimum of
two hours prior to use. The allowable operating environment is as follows:
Operating Temperature Range:
10°C to 40°C (50°F to 104°F)
Operating Humidity Range:
10% to 90% (non-condensing)
Operating Pressure (altitude):
0 to 3,048 m (10,000 ft) altitude (697 mbar)
Important Notes about the ST80i System
ST80i may become inoperative when the front-end (PIM) signal acquisition is interrupted
due to low PIM battery power, loss of wireless communication between the PIM and the
receiver (AIM), and/or loss of USB communication between the AIM and the host PC.
ST80i displays a lead-off condition for all leads when signal acquisition is lost and
absence of signal strength bars when wireless communication is lost. These inoperative
conditions will be saved and indicated on printed reports.
Power off the system and remove the input AC power cord before installing, repairing, or
servicing any hardware.
Proper patient preparation is important for proper application of ECG electrodes and
operation of the device. Use medical tape to fix the lead wires to the chest in order to help
minimize the strain applied to the electrode connections, thus reducing noise and the
possibility of a leads-off condition.
ST80i automatically prevents connection to a LAN or WLAN while the system is
connected to a patient study.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
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