Description Of Device; Intended Use Seca Mvsa 535; Restrictions On Use Of Seca Mvsa 535; Functional Description - Seca mVSA 535 Instructions For Use Manual

2. DESCRIPTION OF DEVICE

2.1 Intended use seca mVSA 535

2.2 Restrictions on use of seca mVSA 535

2.3 Functional description

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seca mVSA 535
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Intended use seca mVSA 535
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Functional description
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User qualification
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Contraindications
The medical Vital Signs Analyzer
for non­invasive, discontinuous measurement and display of NiBP (blood
pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body tem-
perature) and PR (pulse rate).
The vital signs monitor model
ties (hospitals, medical practices and care facilities) in accordance with
national regulations and is intended to be used on adult and pediatric individ-
uals (3 years of age or older).
The can be used in conjunction with an optional seca server
seca mVSA 535
software accessory for reception from and data transfer to external Hospital
Information Systems.
lf used in conjunction with seca medical weight and height measurement
devices the
seca mVSA 535
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 measuring function of the device is not intended for monitoring
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apneas, detecting arrhythmias or for use during defibrillation or electrocauter-
ization.
This device is not suitable for individuals who are connected to electronic life-
support systems, for example artificial heart-lung machine.
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Device components
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Power supply
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Vital signs measurement
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Alarms
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Weight and height
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User IDs of EMR systems
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seca patient files
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Patient data from EMR systems
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Measured results
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Data transmission and network functions
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Compatibility
is a spot-check device used
seca mVSA 535
is mainly used in inpatient facili-
seca mVSA 535
can receive and display weight and height values.