Philips ST80i - Important Patient and Safety Information

Safety Summary
iv ST80i Stress Test System Instructions for Use
Important Patient and Safety Information
Patient and safety information is divided into several sections:
 ST80i Stress Test System (next section)
 Medical isolation transformer (page ix)
 Philips advanced interface module (AIM) (page x)
 Philips wireless patient interface module (PIM) (page xi)
For information about electromagnetic compatibility (EMC) with surrounding devices, see
“Electromagnetic Compatibility (EMC) - To be finalized” on page E-7 of Appendix E,
“Specifications and Requirements”
Safety Information for the ST80i Stress Test System
The Philips ST80i Stress Test System, when operated with the ST80i AIM, AIM data cable,
ST80i PIM, and lead wires, shall meet all of the EMC requirements specified in the following
standards:
 IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment – Part 1 - General
requirements for basic safety and performance
 AAMI EC11:8/2007 - Diagnostic Electrocardiographic Devices
 IEC 60601-2-25:1993 + A1:1999 - Particular requirements for the safety of
electrocardiographs
 AAMI EC53:12/2008 - ECG cables and leadwires
Warning Statements for the ST80i System
WARNING Failure to follow these warnings could affect both patient and operator safety.
 Do not use the ST80i System in the presence of flammable vapors.
 Do not use the ST80i System in the presence of explosive gases. AC power connection/
disconnection or electrostatic discharge (ESD) may result in spark occurring in an
environment where explosive gases are used.
 Submersion and/or conditions that subject the ST80i System to liquid ingress create a
shock hazard.
 When operating the ST80i System, ensure that the system and all other electrical
equipment connected to or near the patient are effectively grounded.
 Do not touch accessible connector pins and the patient simultaneously.
 The ST80i System has been safety tested with the recommended accessories, peripherals,
and leads, and no hazard was found when the system is operated with cardiac pacemakers
or other stimulators.