SH042-1 User Manual for BodiTrak LT V1.5, 25 Jan 2019
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BodiTrak Technical Support: 800-847-3157
device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
2.3 Europe
The manufacturer of this product is in conformity with the European Medical Device
Directive 93/42/EEC and complies with ISO 13485.
2.4 Product Testing
This product has been tested and found to comply with:
• CAN/CSA C22.2 No. 60601-1:2008
• ANSI/AAMI ES 606011:2005/A2:2010
• EN 60601-1:2006/A11:2011
• IEC 60601-1-2:2007 – edition 3
2.5 The following table shows classifications and environmental parameters for the BodiTrak
pressure mat:
Medical Device Type Class 1 with measurement function
Class for electromagnetic
compatibility
Class A
Degree of protection against
electric shock
Type B Applied Part
Degree of protection against
ingress of water
IPX0
Mode of operation Continuous
Environmental Operating
Conditions
10 to 40°C
30 to 75% RH non-condensing
700-1060 hPa
Environment Storage Conditions -40 to +70C
10 to 100% RH non-condensing
500 to 1060 hPa
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