User and Technical Manual: HotDog Temperature Management Controller
Page 22
device. Particular precaution must be considered during use of strong emission sources such as High Frequency
surgical equipment and similar so that, e.g., the HF-cables are not routed on or near the device. If in doubt, contact
a qualified technician or your local representative.
Essential Performance
1. If the applied part cannot reach set point within 10 minutes, the warming device shall turn off and a low
priority technical alert shall be generated
2. Minimum watt density of the heater shall be sufficient to achieve clinically effective warming (0.10 watts per
square inch (155 watts per square meter))
3. Maximum watt density of the heater shall be less than 0.45 watts per square inch (620 watts per square
meter)
4. Patient contact surfaces of the HotDog System shall operate at a set point +/- 5°C at steady state when device
is under even thermal load
5. The thermal storage capacity of the applied part shall be less than 100% of the power output of the heater
6. In normal or single fault conditions, the warming device shall not raise skin temperature above 43°C. If skin
temperatures exceed 43°C, they will stay within the following time/temperature limits:
Time (s)
Temperature (C)
10000
43.5
6000
44
3300
44.5
1990
45
1000
45.5
600
46
350
46.5
225
47
110
47.5
80
48
60
48.5
38
49
28
49.5
22
50
17
50.5
ELECTROMAGNETIC COMPATIBILITY (EMC)
The System requires special precautions regarding EMC and must be installed and put into service according to the
EMC information provided in this User Manual.
Warning
•
Warning per IEC 1-2 Standard:
o
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
o
Use of accessories, transducers, and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
o
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the WC7X, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
