The medical Body Composition Analyzer seca 515/514 is mainly used in
hospitals, medical practices and inpatient care facilities in accordance with
national regulations. The
electric impedance measurements and parameters, e.g. fat-free mass (FFM),
which can be derived from them for automatic calculation. The results are displayed graphically and assist the attending physician with the following medical issues:
• determining energy expenditure and energy reserves as a basis for
nutritional advice
• assessing metabolic activity and the success of a training program, e.g.
within the framework of rehabilitation or physiotherapy
• determining a patient's fluids status
• determining general state of health or, in the case of a previously-known
disease, assessing its severity
seca 515/514 is not a diagnostic device. To make an accurate diagnosis,
The
the physician needs to commission thorough examinations and take their
results into account in addition to the results of the
seca 515/514 device records weight, height and bio-
seca 515/514.
Calculating weight and heightThe device uses an electronic scale. Weight is recorded across 4 load cells.
Height is recorded via manual entry or via wireless transmission from a
seca 360° stadiometer.
Bioimpedance measurementBioimpedance is measured according to the 8-point method. The flow of the
low alternating current and the measurement of impedance are performed for
each side of the body using a pair of foot electrodes and 3 pairs of hand electrodes. The hand electrodes are attached at different heights so that persons
with a height of between 1.60 m and 2.0 m can adopt the ideal position on
the device for a bioimpedance measurement.
Administering patient dataseca patient files can be created directly on the device for administering mea-
sured results. The seca patient files are stored in the patient database of the
seca analytics 115 PC software supplied. Alternatively, seca patient files can
be saved on the USB memory stick supplied. The USB memory stick likewise
contains a seca patient database.
seca patient files and seca patient databases contain exclusively data necessary for working with seca products or determined using seca products. seca
patient files can be administered and edited only using the
software. The export and import functions of the
be used for exchanging data with surgery and hospital information systems.
seca 115 PC software can
seca 115 PC
EvaluationBioimpedance measurements are evaluated in graphical form based on sci-
entifically-established formulas. An in-house study by seca established formulas for determining the parameters of total body water (TBW), extracellular
water (ECW), fat-free mass (FFM) and skeletal muscle mass (SMM) for arms,
legs, torso and the whole body. In the same studies, in-house reference values were determined for the following parameters, in order to allow normal
ranges to be shown: bioelectric impedance vector analysis (BIVA), mass indices (FMI, FFMI), phase angle (φ). You can find further information in the
Instructions for Use for Physicians and Assistants.
Device description • 3
Administration of user dataAccess data for users of the device is administered in the seca 115 PC
software supplied. A user PIN for the seca 515/514 is generated automatically
when user accounts for theseca 115are created. The administrator also has
the option of specifying a user PIN him or herself.
The device can only be configured with administrator rights. An initial administrator PIN for the device is provided. It can only be changed on the device.
The creation and administration of user data is only necessary if the seca
patient database of the
device.
seca 115 PC software is to be accessed from the
Data transmission and network
functions
Compatibility This device (software version 1.1 from Build 550) is compatible only with ver-
The device is networkable. The network connection allows the device to use
both the seca patient database and the special print function of the seca 115
PC software.
The special print function of the
start printing out a detailed results report directly on the medical Body
Composition Analyzer
Alternatively to the Ethernet link, seca mBCAs and the
can communicate wirelessly via seca 360° technology. For this purpose, the
seca 360° wireless USB adapter 456 (included in the scope of delivery) must
be connected to a PC on which at least the application software of the
seca 115 is installed.
seca 360° stadiometers can wirelessly transmit measured results to the
device.
The device has the following interfaces:
• on the weighing platform
– network connection (Ethernet)
• on the touchscreen display
– internal seca wireless module
– USB interface for connecting a USB memory stick (included in the
scope of delivery)
sion 1.4 from Build 560 of the
compatibility with older versions of the seca 115. For a summary of technical
modifications, see the section entitled “Technical modifications” on page 56.
seca mBCAs with older device software can be updated. Go to
www.seca.com and contact your local seca service partner.
seca 515/514.
seca 115 PC software makes it possible to
seca 115 PC software
seca 115 PC software. There is no downward
1.3User qualification
Administration/network connectionThe device may only be set up and incorporated in a network by experienced
administrators or hospital technicians.
Measuring modeThe device and the seca 115 PC software may only be operated by persons
with sufficient specialist expertise.
4 •
English
1.4Contraindications
Bioimpedance measurements may not be performed on patients exhibiting
the following characteristics:
• electronic implants, e.g. cardiac pacemakers
• active prostheses
Bioimpedance measurements may
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
not be performed on persons who are
Device description • 5
2. SAFETY INFORMATION
2.1Safety instructions in these instructions for use
DANGER!
Identifies an exceptionally hazardous situation. If you fail to take note
of this information, serious irreversible or fatal injury will result.
WARNING!
Identifies an exceptionally hazardous situation. If you fail to take note
of this information, serious irreversible or fatal injury may result.
CAUTION!
Identifies a hazardous situation. If you fail to take note of this
information, minor to moderate injury may result.
ATTENTION!
Indicates that the product may have been operated incorrectly. If you
fail to take note of this information, the device may be damaged or the
measured results may be incorrect.
NOTE:
Contains additional information on how to use this device.
2.2Basic safety instructions
Handling the device► Please take note of the instructions in these instructions for use.
► Keep the instructions for use in a safe place. The instructions for use are a
component of the device and must be available at all times.
DANGER!
Risk of explosion
Do not use the device in an environment in which one of the following
gases has accumulated:
► oxygen
► flammable anesthetics
► other flammable substances/gas mixtures
CAUTION!
Hazard to patient, damage to device
Additional devices connected to medical electrical devices must
►
provide evidence of compliance with the relevant IEC or ISO standards (e.g. IEC 60950 for data-processing devices). Furthermore, all
configurations must comply with the requirements of standards for
medical systems (see IEC 60601-1-1 or Section 16 of the 3rd edition of IEC 60601-1 respectively). Anyone connecting additional devices to medical electrical devices is considered a system configurer
and is therefore responsible for ensuring that the system complies
with the requirements of standards for systems. Your attention is
drawn to the fact that local laws take precedence over the abovementioned requirements of standards. In the event of any queries,
please contact your local specialist dealer or Technical Service.
► Please have maintenance, subsequent verification (seca 515 only)
and BIA measuring technology checks performed every two years.
► Technical modifications may not be made to the device. The device
does not contain any parts for servicing by the user. Please only
have maintenance, technical checks and repairs performed by an
authorized service partner. You can find a service partner in your
area at www.seca.com or by sending an e-mail to
service@seca.com.
► Use only original accessories and seca spare parts, otherwise seca
will not grant any warranty.
6 •
English
CAUTION!
Hazard to patient, malfunction
Keep other medical devices, e.g. high-frequency surgical devices,
►
at a minimum distance of approx. 1 meter to prevent incorrect
measurement or wireless transmission interference.
► Keep high-frequency devices such as cellphones at a minimum
distance of approx. 1 meter to prevent incorrect measurement or
wireless transmission interference.
► The actual transmission output of high-frequency equipment may
require minimum distances of more than 1 meter. For details, go to
www.seca.com.
Preventing electric shockWARNING!
Electric shock
Set up devices which can be operated with a power pack so that
►
the power supply socket is within easy reach and the power supply
can be quickly disconnected.
► Ensure that your local power supply matches the details on the
power pack.
► Never touch the power pack with wet hands.
► Do not use an extension cable and multiple outlets. This also applies
to the USB connection on the touchscreen display.
► Make sure that the power cable is not crushed and cannot be
damaged by sharp edges.
► Do not operate the device above an altitude of 3000 m.
Preventing injuries and infectionsWARNING!
Hazard to patient
Subject the device to a hygiene treatment after each measurement
►
(see “Troubleshooting” on page 51).
► Ensure that the patient does not have any contagious diseases.
► Ensure that the patient does not have any open wounds on the
palms of their hands or the soles of their feet.
► Ensure that the device is steady and level.
► The device is not designed as a standing aid. Assist people with
limited mobility, e.g. when they are getting up from a wheelchair.
► Ensure that the weighing platform is dry before the patient steps
onto it.
► Ensure that the patient has dry feet before stepping onto the
weighing platform.
► Ensure that the patient does not step directly onto the edges of the
weighing platform.
► Ensure that the patient steps onto the weighing platform slowly and
safely.
► Route the network and power cables such that no one can trip over
them.
WARNING!
Risk of infection
Before and after every measurement, wash your hands to reduce
►
the risk of cross-contamination and nosocomial infections.
► Hygienically reprocess the scale regularly as described in the re-
spective section in this document.
► Make sure that the patient has no infectious diseases.
► Make sure that the patient has no open wounds or infectious skin
alterations, which may come into contact with the device.
Safety information • 7
Preventing device damageATTENTION!
Damage to device
Make sure that fluids never get inside the device. These can destroy
►
the electronics.
► Switch off the device before you disconnect the power pack from
the power supply.
► If the device is not be used for an extended period, disconnect the
power pack from the power supply. Only then is the device deenergized.
► Do not drop the device.
► Do not subject the device to shocks or vibrations.
► Do not place the device in direct sunlight and make sure that it is not
placed in the direct proximity of a heat source. The excessive temperatures could damage the electronics.
► Perform a function check at regular intervals as described in the cor-
responding section in the “Instructions for Use for Physicians and
Assistants”. Do not operate the device if it is not working properly or
is damaged.
► Avoid rapid temperature changes. If the device is transported so
that a temperature difference of over 20 °C occurs, the device must
be left to stand for at least 2 hours before it is switched on, otherwise condensation may form; this can damage the electronics.
► Use only disinfectants free of chlorine and alcohol and which are ex-
plicitly suitable for acrylic sheet and other sensitive surfaces (active
ingredient: quaternary ammonium compounds, for example).
► Do not use aggressive or abrasive cleaning agents.
► Do not use organic solvents (e.g. white spirit or petroleum spirit).
Dealing with measuring resultsWARNING!
Hazard to patient
The seca 515/514 is not a diagnostic device. The device assists the
attending physician in reaching a diagnosis.
► To reach a precise diagnosis and to initiate therapies, the attending
physician must have thorough examinations conducted and take
the results of these into consideration, as well as using the seca 515/
514
.
► The responsibility for diagnoses and the therapies derived from
them lies with the attending physician.
CAUTION!
Hazard to patient
To prevent misinterpretations, measured results for medical purposes
may only be displayed and used in SI units (weight: kilograms, height:
meters). Some devices have the option of displaying measured results
in different units. This is purely an additional function.
► Only use measurements in SI units.
► The user takes sole responsibility for the use of measured results in
non-SI units.
ATTENTION!
Loss of data
Before you save and re-use values measured with the seca 515/514
►
(e.g. in the seca PC software or in a hospital information system),
ensure that the measured values are plausible.
► If measured values have been transmitted from the seca 515/514
device to seca PC software or to a hospital information system, ensure before re-using them that the measured values are plausible
and assigned to the correct patient.
8 •
English
ATTENTION!
Measurements from third-party devices not compatible
Bioimpedance measurements performed by devices from different
manufacturers are not compatible. Follow-up measurements performed on a device other than a seca medical Body Composition
Analyzer may lead to inconsistent data and misinterpreted measured
results.
► Ensure that follow-up measurements are also performed on a seca
medical Body Composition Analyzer.
Dealing with packagingWARNING!
Danger of suffocation
Packaging made of plastic film (bags) presents a danger of
suffocation.
► Store packaging out of the reach of children.
► If the original packaging is no longer available, only use plastic bags
with safety holes to reduce the risk of suffocation.
NOTE:
Store the original packaging for future use (e.g. returning for
maintenance).
Safety information • 9
3. DEVICE OVERVIEW
2
3
6
4
7
5
1
8
9111012
Front
Rear
Rear of weighing platform
3.1Controls
No.ControlFunction
Switches device on: press button briefly
1
2
ON/OFF button with LED
Touchscreen displayCentral control and display element, can be swiveled 180° to left and right
Switches device to standby: press button briefly
Switches device off: press button and hold
10 •
English
No.ControlFunction
For connecting a USB memory stick (contained in the scope of delivery)
for administering the following data:
• creating seca patient files on the device
USB interface
3
Pair of hand electrodes, right
4
Spirit levelShows whether the device is horizontal
5
Pair of foot electrodes, rightFor heels and balls of feet, for bioimpedance measurement
6
Pair of foot electrodes, leftFor heels and balls of feet, for bioimpedance measurement
7
Pair of hand electrodes, left
8
Foot screws, right2 pcs, for precise alignment of the device
9
Power pack connectionFor connecting the power pack
10
Ethernet interfaceFor integrating the device in a PC network
11
Foot screws, left2 pcs, for precise alignment of the device
12
• loading seca patient files from the seca 115 PC software supplied onto
the USB memory stick; calling up data on the device
• saving measured results to the USB memory stick
• reading out log files from the device (administrator function)
3 pcs. with finger spacers, for bioimpedance measurement
The patient selects an electrode pair depending on their height
3 pcs. with finger spacers, for bioimpedance measurement
The patient selects an electrode pair depending on their height
Device overview • 11
3.2Symbols in the start display
A
C
I
J
E
D
K
L
M
F
O
Q
N
G
H
P
B
SymbolMeaning
A
B
C
D
Header, remains unchanged in all menu levels and tabs. The following
data are displayed:
•patient data
-name
-weight
-height
-BMI
• data connections
•date/time
Login symbol:
indicates whether the user is logged in to a seca patient database (user
PIN required)
Printer symbol:
indicates whether the print function of the seca 115 PC software is
available
Measuring rod symbol:
indicates whether there is a connection to a seca 360° stadiometer
12 •
English
SymbolMeaning
Data connection symbol:
indicates the current type of connection to the seca patient database (in
this case Ethernet connection between PC and
Additional possible connection types:
seca 115
E
• seca 360° wireless connection between PC and seca 115
• USB memory stick connected to device
G
H
K
M
F
I
J
L
Weight display
weight/height tab
Automatically active after device is switched on
For determining weight and height of patient
bia tab
For performing a bioimpedance analysis
patient tab
For assigning the measured results to a seca patient file
evaluation tab
For evaluating measured results and analysis results and for saving data
menu changeover button
Appears if secondary menu is available
• Primary menu: contains the functions commonly used in the current
context
• Secondary menu, contains the following functions:
settings
-
- print
- save
Menu bar with context-dependent buttons and menu changeover button
Hold value display
Weighing range currently in use:
N
O
P
Q
• 1: finer divisions of the weight display at a lower capacity
• 2: maximum capacity
Non-verifiable function is active (for verified models only)
Display of patient's height
• Can be entered manually
• Can be received by a seca 360° stadiometer
Display of patient's body mass index (BMI)
Calculated automatically as soon as a weight is available and a height
value has been received or entered
Device overview • 13
3.3Color symbols and other controls
Control/displaySymbolMeaning
LED white: device on
ON/OFF button
Data connection
symbol, in this case
seca 360° wireless link
between a PC and
seca 115
Login symbol: log in to a
seca patient database
Tab
LED green: device on standby
LED off: device off
White: connection available
Red: data being transmitted on the available connection