Atracsys fusionTrack 500, Руководство пользователя

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User manual
Version: v4.5.2
Model Remark
Lenovo ThinkPad USB 3.0 Ethernet Adapter P/N:
4X90E51405 7 kbits Jumbo frames maximum.
Table 5.6: List of tested Ethernet to USB adapters.
5.6.1 The fusionTrack
Even though no patient contact is necessary for the fusionTrack in normal operation, the fusionTrack has
to be considered as Type B applied part since the fusionTrack can potentially be placed within the patient
environment (up to 1
. 5 m from the patient). Also indirect connection is possible if for example the surgeon
touches the patient at the same time that they are touching the fusionTrack to adjust its position.
A Type B applied part according to the medical standard 60601-1 has to comply with:
- Requirements of the 60601-1 to provide protection against electric shock ;
- Requirements of the 60601-1 regarding touch current / enclosure leakage current ;
- Requirements of the 60601-1 regarding patient leakage current ;
- Requirements of the 60601-1 regarding patient auxiliary current .
Patient leakage current and patient auxiliary current are not applicable since the fusionTrack has no
patient connection (Type B applied part); it is only considered as Type B applied part.
Therefore only the two following requirements have to be respected:
- Requirements of the 60601-1 to provide protection against electric shock ;
- Requirements of the 60601-1 regarding touch current / enclosure leakage current .
fusionTrack protection against electric shock
The fusionTrack is certified following the medical standard 60601-1. Following this standard, two Means
of Patient Protection (2 MOPP) are necessary in order to guarantee the patient’s safety. The fusionTrack
systems provide 2 MOPP between the Ethernet connection (working voltage of up to 56VDC for
PoE +) and
the housing of the fusionTrack:
Description Standard Working
Voltage Withstanding
Voltage Creepage
Distance Air Clearance
fusionTrack 60601-1 57 V DC 3000 V rms 4 . 6 mm 2 . 5 mm
fusionTrack touch current / enclosure leakage current
The fusionTrack system on a 57VDC source using the passive Gigabit Midspan Injector L-com - BTCAT6-
P1-HP PoE has the following maximum leakage currents measurements:
Condition Standard leakage current measurement Leakage current measurement non-
frequency-weighted device
Maximum
measurement Allowable
value Maximum
measurement Allowable
value
Normal condition 49 µA 100 µA 0
.
179 mA 10 mA
Single fault condition 179 µA 500 µA 0
.
136 mA 10 mA
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