10 • secamVSA 535/seca mBCA 525
17-10-05-353-002g_10-2020 B
2.4 User qualification
Administration/network connection The device may only be set up and incorporated in a network by experienced
administrators or hospital technicians.
Measuring mode The device may only be used by persons with sufficient expertise.
Basic knowledge required for measuring vital parameters is not the subject of
these instructions for use.
Connecting the device to an EMR system affects the measuring sequence
and operation of the device:
➔ Operation when connected to an EMR
system. People operating the device must be informed about these effects.
2.5 Contraindications
The device is not intended for permanent monitoring of patients.
The device is not intended for patient monitoring during either transport (for
example, in ambulances or helicopters) or transfer within an institution.
The device is not intended for operation in the vicinity of an MRI device or in a
pressurized chamber.
The SpO
2
measuring function of the device is not intended for monitoring
apneas, detecting arrhythmias or for use during defibrillation or
electrocauterization.
This device is not suitable for persons with the following characteristics:
• Cramps
• Tremors
This device is not suitable for individuals who are connected to electronic life-
support systems, for example, artificial heart/lung.
Bioimpedance measurements may
not be performed on individuals exhibiting
the following characteristics:
• electronic implants, e.g. cardiac pacemakers
• active prostheses
Bioimpedance measurements may
not be performed on persons who are
connected to one of the following devices:
• electronic life-support systems, e.g. artificial heart, artificial lung
• portable electronic medical devices, e.g. ECG devices or infusion
pumps
Impedance measurements may only be performed on persons exhibiting the
following characteristics after discussion with the attending physician:
• cardiac arrhythmias
• pregnancy
➔ Administration/network connection
➔ Measuring mode
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