2 Site Preparation
21
Connecting Non-Medical Devices
The standard IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 applies to any combination of
devices, where at least one is a medical device. Therefore IEC 60601-1:2005+A1:2012/EN 60601-
1:2006+AC:2010 must still be met after all devices are connected.
WARNING
• Do not use a device in the patient vicinity if it does not comply with IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010. The whole installation, including devices outside of the patient
vicinity, must comply with IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010. Any non-
medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and
operated in the patient’s vicinity must be powered via a separating transformer (compliant with
IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010) that ensures mechanical fixing of the
power cords and covering of any unused power outlets.
• Do not connect any devices that are not supported as part of a system.
Whenever you combine equipment to form a system, for example, connecting the monitor to an
OB TraceVue system/IntelliSpace Perinatal system, perform a system test according to IEC 60601-
1:2005+A1:2012/
EN 60601-1:2006+AC:2010 (see “Touchscreen Calibration” on page 96).
Measurement Essential Performance
All
After electrostatic discharge, fast transients/bursts, surges and electro surgery
interference, the equipment will return to previous operation mode within
10 seconds (SpO
2
30 seconds) without loss of any stored data.
After voltage interruptions the equipment returns to previous state without
operator intervention and loss of data.
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