Regulatory Information
Safety Standards & Specifications
12-3
Safety
Standards
The device complies with the following safety requirements for medical
electrical equipment:
• IEC 601-1:1988 + A1:1991 + A2:1995 General Requirements for Safety
(with worldwide deviations, including U.S. deviations)
• IEC 60601-1-1:2000 System Safety
• IEC 60601-1-2:2001 Electromagnetic Compliance
• IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems
• ISO 10993-1:2003 Biocompatibility (for lead wires and pouch)
• ISO 9919:2005 Pulse Oximeters
• EN 865:1997 Particular Requirements for Pulse Oximeters
• AAMI EC 13:2002 Performance Standard, Cardiac Monitors
Essential Performance
The IntelliVue Telemetry System provides Essential Performance (EP) under
normal operating conditions (includes EMC exposure) only as a complete
Medical Electrical System, consisting of the TRx4841A or TRx4851A
Transceivers, the IntelliVue Telemetry Network Infrastructure, the M3150
Information Center, the M2636C TeleMon Companion Monitor (optional), and
the M8105A/T MP5/5T, M8102A MP2, and M3002A X2 IntelliVue Patient
Monitors (optional).
The IntelliVue Telemetry System achieves its Essential Performance exclusively
through alarm generation at the M3150 Information Center.
The IntelliVue Telemetry System protects the patient from unacceptable
immediate clinical risk by generating specific Physiological Alarms when
appropriate. If the System cannot generate Physiological Alarms, then relevant
Severe or Hard Technical Alarms (Inoperative Conditions) are created.
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