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.
Summary of Contents for Avalon FM20
Page 2: ......
Page 6: ...6 ...
Page 38: ...3 Installation Instructions 38 ...
Page 46: ...4 Theory of Operation 46 ...
Page 155: ...10 Repair and Disassembly 155 11 Put the two halves of the display assembly together as shown ...
Page 167: ...10 Repair and Disassembly 167 10 Remove the four screws holding the recorder chassis ...
Page 169: ...10 Repair and Disassembly 169 12 Remove the RFI bracket 13 Lift out the recorder chassis ...
Page 254: ...12 Specifications 254 ...
Page 259: ......
Page 260: ...Part Number 453564541271 Published in Germany 11 14 453564541271 ...