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80 Information for the doctor and qualified medical staff
A device must comply with the regulations under DIN EN 60601-1
for medical devices or under DIN EN 60950 for communication tech-
nology devices before it is connected to the USB or AUX ports. In
addition, the leakage current from the VitaGuard® must be meas-
ured as stipulated in the standard DIN EN 60601-1-1. This leakage
current must not exceed 100 µA. Only qualified medical device
technicians can check whether the leakage current conforms to the
standards.
When several devices are connected to each other, the individual
leakage currents can add up and may pose a risk to the patient.
Do not connect printers, cameras, scanners, or other devices.
9.1.3 VitaGuard® and other medical devices
When VitaGuard® is to operate at the same time as a defibrillator,
the monitoring results may be invalid for a short time. In addition,
defibrillation can damage the cables. Check the monitoring system
after defibrillation.
Bear in mind that an external defibrillation pulse can be attenuated.
A test in accordance with DIN EN 60601-2-49 showed that defibrilla-
tion pulses emitted during monitoring are attenuated by less than 10 %.
Do not use VitaGuard® in conjunction with HF surgical equipment,
TENS devices, or nerve stimulators.
VitaGuard® correctly interprets pacer pulses with amplitudes
greater than 5 mV, so VitaGuard® can be used on patients with pace
makers.
Warn your pacemaker patients that the displayed pulse rate may
possibly be affected by stimulating pulses. Point out to the caregiv-
ers that they must carefully observe pacemaker patients.
Do not operate VitaGuard® near MRI devices (magnetic resonance
imaging) or other systems that generate strong electromagnetic
fields. Leads can heat up by induction, causing fire in the cables. The