seca 515/514
Instructions for use
for
doctors and assistants
Software version 1.1
English
CONTENTS
1. Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Congratulations! . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Description of function. . . . . . . . . . . . . . . . . . . . . . 4
Recording weight and height . . . . . . . . . . . . . . . 4
Bioimpedance measurement . . . . . . . . . . . . . . . 4
Management of patient data. . . . . . . . . . . . . . . . 4
Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Management of user data. . . . . . . . . . . . . . . . . . 5
Data transmission and network functions . . . . . . 5
Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 User qualification . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Administration/network connection. . . . . . . . . . . 6
Measuring mode . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . 6
2. Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Safety rules in the instructions for use . . . . . . . . . . 7
2.2 Basic safety information. . . . . . . . . . . . . . . . . . . . . 7
Handling the device . . . . . . . . . . . . . . . . . . . . . . 7
Preventing electric shock . . . . . . . . . . . . . . . . . . 8
Preventing injuries and infections . . . . . . . . . . . . 8
Preventing device damage . . . . . . . . . . . . . . . . . 8
Dealing with measuring results . . . . . . . . . . . . . . 9
Dealing with packaging. . . . . . . . . . . . . . . . . . . 10
3. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 Symbols in the start display. . . . . . . . . . . . . . . . . 13
3.3 Color symbols and other controls . . . . . . . . . . . . 15
3.4 Identification on the device and the type plate . . . 16
3.5 Identification on the packaging . . . . . . . . . . . . . . 17
4. Before you really get started .... . . . . . . . . . . . . . . . . 18
4.1 Scope of delivery. . . . . . . . . . . . . . . . . . . . . . . . . 18
4.2 Establishing power supply . . . . . . . . . . . . . . . . . . 19
4.3 Setting up the device. . . . . . . . . . . . . . . . . . . . . . 19
4.4 Configuring the device. . . . . . . . . . . . . . . . . . . . . 20
4.5 Operating the device in a PC network . . . . . . . . . 20
Connecting the network via Ethernet or
seca 360° wireless network . . . . . . . . . . . . . . . 20
Printing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Indirect connection via USB memory stick . . . . 21
4.6 Operation using a seca 360° length measuring
device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1 Operating concept. . . . . . . . . . . . . . . . . . . . . . . . 23
Swiveling the touchscreen display . . . . . . . . . . 23
Switching on the device . . . . . . . . . . . . . . . . . . 23
Selecting functions . . . . . . . . . . . . . . . . . . . . . . 23
Selecting extended functions . . . . . . . . . . . . . . 24
Entering text. . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Display special characters . . . . . . . . . . . . . . . . 25
Entering numbers. . . . . . . . . . . . . . . . . . . . . . . 25
Measuring procedure . . . . . . . . . . . . . . . . . . . . 26
Automatic standby . . . . . . . . . . . . . . . . . . . . . . 26
Switching off the device . . . . . . . . . . . . . . . . . . 26
5.2 Determining weight and height . . . . . . . . . . . . . . 27
Starting the weighing procedure. . . . . . . . . . . . 27
Manually determining hold value (hold) . . . . . . . 28
Taring off additional weight (tare) . . . . . . . . . . . 28
Permanently storing additional weight
(pre-tare) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Activating/deactivating pre-tare function. . . . . . 29
Entering height manually. . . . . . . . . . . . . . . . . . 29
Transmitting height via
seca 360° wireless network . . . . . . . . . . . . . . . 29
Calculating BMI automatically. . . . . . . . . . . . . . 30
Switching weighing range automatically . . . . . . 30
Printing partial results . . . . . . . . . . . . . . . . . . . . 30
5.3 Performing a bioimpedance measurement . . . . . 31
Switching on the device . . . . . . . . . . . . . . . . . . 31
Determining weight and height . . . . . . . . . . . . . 31
Checking module selection. . . . . . . . . . . . . . . . 31
Starting measurement . . . . . . . . . . . . . . . . . . . 32
Entering PAL value and waist
circumference . . . . . . . . . . . . . . . . . . . . . . . . . 35
Printing partial results . . . . . . . . . . . . . . . . . . . . 36
5.4 Assigning a measurement to a patient file . . . . . . 36
Checking data connection . . . . . . . . . . . . . . . . 36
Logging on to a seca patient database. . . . . . . 36
Searching for a seca patient file. . . . . . . . . . . . 37
Providing a seca patient file from the
PC software . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Creating a new seca patient file . . . . . . . . . . . . 40
Editing patient data . . . . . . . . . . . . . . . . . . . . . 41
5.5 Viewing analyses . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.6 Closing the measuring procedure . . . . . . . . . . . . 43
Saving the measured results. . . . . . . . . . . . . . . 43
Printing results report . . . . . . . . . . . . . . . . . . . . 44
Logging off from a seca patient database. . . . . 44
6. Medical basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.1 Bioimpedance analysis (BIA) . . . . . . . . . . . . . . . . 45
Classic body composition analysis . . . . . . . . . . 45
Functional principle of bioimpedance
analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Pioneering achievement: seca formulas . . . . . . 46
6.2 Evaluation parameters. . . . . . . . . . . . . . . . . . . . . 47
Summary of evaluation parameters . . . . . . . . . 47
seca specialty: co-ordinate system with
tolerance ellipses . . . . . . . . . . . . . . . . . . . . . . . 49
6.3 Evaluation modules . . . . . . . . . . . . . . . . . . . . . . . 50
Development/growth . . . . . . . . . . . . . . . . . . . . 50
Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Function/rehabilitation . . . . . . . . . . . . . . . . . . . 54
Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Health risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Raw data for impedance . . . . . . . . . . . . . . . . . 59
6.4 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7. Configuring the device. . . . . . . . . . . . . . . . . . . . . . . . 61
7.1 Adapting default module selection for
bioimpedance analysis . . . . . . . . . . . . . . . . . . . . 61
Showing/hiding default module selection . . . . . 61
Creating default module selection. . . . . . . . . . . 62
7.2 Saving settings . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Applying settings . . . . . . . . . . . . . . . . . . . . . . . 63
Exiting Settings\user menu. . . . . . . . . . . . . . . . 63
8. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.3 Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
2 •
9. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10. Maintenance/subsequent verification
(verified model) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.1 Information on maintenance and subsequent
verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.2 Checking the contents of the verification
counter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
11. Maintenance (unverified model) . . . . . . . . . . . . . . . 66
12. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
12.1 Power supply and display . . . . . . . . . . . . . . . . . 67
12.2 Height and weight . . . . . . . . . . . . . . . . . . . . . . . 67
12.3 Bioimpedance analysis . . . . . . . . . . . . . . . . . . . 68
12.4 Data transmission . . . . . . . . . . . . . . . . . . . . . . . 69
12.5 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
13. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
13.1 General technical data. . . . . . . . . . . . . . . . . . . . 71
13.2 Technical data, bioimpedance analysis . . . . . . . 72
13.3 Weighing data (verified model). . . . . . . . . . . . . . 73
13.4 Weighing data (unverified model) . . . . . . . . . . . . 73
13.5 Technical modifications . . . . . . . . . . . . . . . . . . . 74
14. Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . 74
15. Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
16. Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
17. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
• 3
1. DEVICE DESCRIPTION
1.1 Congratulations!
1.2 Intended use
With the Medical Body Composition Analyzer seca 515/514, you have just
purchased a highly precise and simultaneously robust device.
For more than 170 years, seca has used its experience in the service of health
care and, as a market leader, it has always set standards in many countries of
the world with innovative developments for weighing and measuring.
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 derivable parameters, e.g. fat-free
mass (FFM), 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 severity
seca 515/514 is not a diagnostic device. To make an accurate diagnosis,
The
in addition to the results of the
be ordered by the physician and their results taken into account.
seca 515/514 device records weight, height and bio-
seca 515/514, targeted examinations have to
1.3 Description of function
Recording weight and height The device uses an electronic scale. Weight is recorded across 4 load cells.
Bioimpedance measurement Bioimpedance is measured according to the 8-point method. The flow of the
Management of patient data seca patient files can be created directly on the device to manage measured
Height is recorded via manual entry or via wireless transmission from a
seca 360° length measuring device.
low alternating current and the measurement of impedance are performed for
each side of the body using a pair of foot electrodes and three 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.
results. The seca patient files are stored in the patient database of the
seca analytics 115 PC software supplied. Alternatively, seca patient files can
also 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 managed and edited only using the
The export and import functions of the seca 115 PC software can be used for
exchanging data with surgery and hospital information systems.
seca 115 PC software.
4 •
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Analysis Bioimpedance measurements are analyzed in graphical form based on scien-
tifically-established formulas. In-house studies 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 whole body. In the same studies, in-house reference values were
determined for the the following parameters in order to be able to show normal ranges: bioelectric impedance vector analysis (BIVA), mass indices (FMI,
FFMI), phase angle (φ). Further information is available in the section entitled
“Medical basis” from page 45.
Management of user data Access data for users of the device are managed in the seca 115 PC software
supplied. In the course of the creation of user accounts for the
user PIN is automatically generated for the
seca 515/514.
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 management of user data is thus only necessary if the seca
patient database of the
seca 115 PC software is to be accessed using the
device.
seca 115, a
Data transmission and network
functions
Compatibility This device (software version 1.1) is compatible only with version 1.4 of the
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
seca 115 PC software makes it possible to
start printing out a detailed results report directly on the Medical Body Composition Analyzer
Alternatively to the Ethernet link, seca mBCAs and the
seca 515/514.
seca 115 PC software
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° length measuring devices 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 (contained in the
scope of delivery)
seca 115 PC software. The is no downward compatibility with older versions
of the seca 115. For a summary of technical modifications, see the section
entitled “Technical modifications” on page 74.
Device description • 5
1.4 User qualification
Administration/network connection The device may only be set up and connected to a network by experienced
administrators or hospital technicians.
Measuring mode The device and the seca 115 PC software may only be operated by persons
with sufficient specialist expertise.
1.5 Contraindications
Bioimpedance measurements may not be performed on persons 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
Bioimpedance 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
6 •
English
2. SAFETY INFORMATION
2.1 Safety rules in the 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.
NOTICE!
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.
2.2 Basic safety information
Handling the device ► Please take note of the information 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/air mixtures
CAUTION!
Hazard to patient, damage to device
• Additional devices connected to electrical medical 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 electrical medical 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 (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 the service
partner in your area at www.seca.com or by sending an e-mail to
service@seca.com.
seca 515),
Safety information • 7
• Use only original accessories and spare parts from seca, otherwise
seca will not grant any warranty.
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
measurements or faults with wireless transmission.
• Keep HF devices such as cellphones at a minimum distance of
approx. 1 meter to prevent incorrect measurement or faults with
wireless transmission.
• The actual transmission output of HF equipment may require
minimum distances of more than 1 meter. Details can be found at
www.seca.com.
Preventing electric shock WARNING!
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 information on the
power supply unit.
• Never touch the power supply 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 infections WARNING!
Hazard to patient
• Subject the device to a hygiene treatment after each measurement
(see “Hygiene treatment” on page 64).
• 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 to be 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 cable such that no one can trip over
them.
Preventing device damage NOTICE!
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
de-energized.
• Do not drop the device.
8 •
English
• 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 function checks regularly as described in the relevant section in this document. Do not operate the device if it is damaged or
not working properly.
• Avoid rapid temperature changes. If the device is transported where
a temperature difference of more than 20 °C occurs, the device
must be left to stand for at least two hours before it is switched on,
otherwise condensation may form; this can damage the electronics.
• Use only chlorine and alcohol-free disinfectants which are explicitly
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 results WARNING!
Hazard to patient
seca 515/514 is not a diagnostic device. The device assists the
The
attending physician in reaching a diagnosis.
► To reach a precise diagnosis and to initiate therapies, the attending
physician must conduct thorough examinations and take the results
of these into consideration, as well as using the
► 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.
NOTICE!
Loss of data
• Before you save and re-use values measured with the
(e.g. in the
tem), make sure that the measured values are plausible.
• If measured values have been transmitted from the
device to the
tem, make sure before re-using them that the measured values are
plausible and assigned to the correct patient.
NOTICE!
Measurements from third-party devices not compatible
Bioimpedance measurements taken with 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 to misinterpretations of the measured
results.
► Ensure that follow-up measurements are also performed on a seca
Medical Body Composition Analyzer.
seca 515/514.
seca 515/514
seca 115 PC software or in a hospital information sys-
seca 515/514
seca 115 PC software or to a hospital information sys-
Safety information • 9
Dealing with packaging WARNING!
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 danger of suffocation.
NOTE:
Store the original packaging for future use (e.g. returning for
maintenance).
10 •
English
3. OVERVIEW
2
3
6
4
7
5
1
8
9
11
10
12
Front
Rear
Rear of weighing platform
3.1 Controls
No. Control Function
To switch on the device: press button briefly
1
2
ON/OFF button
Touchscreen display Central control and display element, can be swiveled 180° to left and right
To switch the device to standby: press button briefly
To switch off the device: press button and hold
Overview • 11
No. Control Function
For connecting a USB memory stick (contained in the scope of delivery)
for managing the following data:
• creating seca patient files on the device
USB interface
3
Pair of hand electrodes, right
4
Spirit level Shows whether the device is horizontal
5
Pair of foot electrodes, right For heels and balls of feet, for bioimpedance measurement
6
Pair of foot electrodes, left For heels and balls of feet, for bioimpedance measurement
7
Pair of hand electrodes, left
8
Foot screws, right 2 pcs, for precise alignment of the device
9
Power pack connection For connecting the power pack
10
Ethernet interface For integrating the device in a PC network
11
Foot screws, left 2 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 device
• saving measured results on 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
12 •
English
3.2 Symbols in the start display
A
C
I
J
E
D
K
L
M
F
O
Q
N
G
H
P
B
Symbol Meaning
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:
shows 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:
shows whether there is a connection to a seca 360° length measuring
device
Overview • 13
Symbol Meaning
Data connection symbol:
shows the current connection type to the seca patient database (in this
case: Ethernet connection to PC using
Additional possible connection types:
seca 115)
E
• seca 360° wireless connection to PC using seca 115
• USB memory stick connected to device
M
F
G
H
I
J
K
L
Weight display
weight/height tab
Automatically active after device 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
analysis tab
For analyzing measured results and analysis results and for saving data
switch menu 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 switch menu button
Hold value display
14 •
Weighing range currently in use:
N
O
P
Q
• 1: finer increments of the weight display at a lower capacity
• 2: maximum capacity
Non-verifiable function is active (only for verified models)
Display of patient's height
• Can be entered manually
• Can be received by a seca 360° length measuring device
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
English
3.3 Color symbols and other controls
Control/display Symbol Meaning
LED white: device on
ON/OFF button
Data connection
symbol, in this case:
seca 360° wireless
connection to a PC with
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 via the available connection
Gray: connection not available
White: user is logged in
Gray: no user logged in
White: tab not selected
Red: tab selected
Light gray: function available
Buttons
Electrode indicator (for
bioimpedance
measurement)
Drop-down triangles
Checkboxes
Gray: button pressed, function selected
Dark gray: function not available
Red: contact poor
Green: contact good
Gray: function available
Light gray: function not available
No tick: function deactivated
Tick: function activated
Overview • 15
Control/display Symbol Meaning
x
xx
0109
0123
Selected function
Drop-down menu
Drop-down menu open
Red text: value outside normal range
Text color
Gray text: value within normal range
3.4 Identification on the device and the type plate
Text/symbol Meaning
Mod Model number
Approval type Type designation of design approval (only
S/N Serial number, consecutive
ProdID Product identification number, consecutive
seca 515)
Follow instructions for use
Medical electrical device, type BF
Insulated device, protection class II
Conformity symbol in compliance with directive 2009/23/EC for non-automatic scales
(verified models)
Value in mass units (verified models)
e
Gives the difference between two consecutive display values
Used to classify and verify a scale
d
Value in mass units (unverified models)
Gives the difference between two consecutive display values
Weighing range (verified models)
Device conforms to EC directives
•
xx: year in which EC verification was performed and the CE mark was applied (verified
models)
• 0109: appointed office for metrology (verified models): Hessen Weights & Measures Office
[Hessische Eichdirektion, Germany]
0123: appointed office for medical devices: TÜV SÜD Product Service
•
Class III scale to Directive 2009/23/EC and OIML R76-1
16 •
English
Text/symbol Meaning
12 V
min. 1,25 A
use compatible
seca adapter only
Operate device only with an original seca power pack
USB interface
Do not dispose of device with household waste
3.5 Identification on the packaging
Protect from wet
Arrows point to top of product
Transport and store upright
Fragile
Do not throw or drop
Permitted min. and max. temperature for transport and
storage
Permitted min. and max. humidity for transport and
storage
Packaging can be disposed of via recycling programs
Overview • 17
4. BEFORE YOU REALLY GET STARTED ...
a
b
c
ghf
e
d
4.1 Scope of delivery
seca 115
User Docs
No. Component Pcs.
Medical Body Composition Analyzer (mBCA) 1
a
Power pack 1
b
DVD with seca 115 PC software and license for one permanent workplace 1
c
“User Documentation” DVD with user documentation in PDF format:
• instructions for use for doctors and assistants
d
• administrator manual
• additional information
Instructions for use for doctors and assistants, printed 1
e
seca 360° wireless USB adapter 456 1
f
seca USB memory stick, 2 GB, initialized (USB PIN: 0000) 1
g
Ethernet cable (1.5 m) for connecting to a TCP/IP network 1
h
515/514
seca
1
18 •
English
4.2 Establishing power supply
4.3 Setting up the device
WARNING!
Using the wrong power packs may cause bodily injury or
damage to the device
Conventional power packs may deliver a higher voltage than is indicated on them. The device may overheat, catch fire, melt or shortcircuit.
► Use only the original seca power pack as contained in the scope of
delivery and listed in the section entitled “Spare parts” on page 74.
The connection for the power pack is located on the underside of the weighing platform. To establish the power supply, proceed as outlined below.
1. Insert the plug required for your power supply into the power pack.
2. Tilt the device forward.
3. Insert the device plug of the power pack into the connector socket of the
device.
4. Carefully return the device to an upright position.
5. Plug the power pack into a power supply socket.
The device is fully assembled upon delivery.
NOTICE!
Incorrect measurement due to force shunt
If the device with its housing is in contact with something, e.g. due to
an uneven or soft floor covering, weight will not be measured correctly.
► Set up the device so that only its foot screws are in contact with the
floor.
1. Place the device on a firm, level surface.
NOTICE!
Incorrect alignment may cause incorrect measurements
The spirit level is very sensitive. Additional weights, such as towels,
can result in incorrect scale alignment.
► Align the device only without a load on it.
2. Level the device by turning the foot screws.
The air bubble in the spirit level must be located in the center of the circle.
Before you really get started ... • 19
4.4 Configuring the device
seca 115
Sections 4.5 to 4.6 show the data transmission options provided by the
device. Your administrator or hospital technician will decide which data connection types to set up for your device. Additional configuration options can
be found in the administrator manual on the “User Documentation” DVD supplied. If you have any requests for changes, please contact your administrator
or hospital technician.
NOTICE!
Loss of data
Incorrect installation or incorrect changes to the installation can lead
to loss of data and, as a result, to misdiagnoses.
► Make sure the installation or changes to the installation are carried
out by an experienced administrator or hospital technician.
4.5 Operating the device in a PC network
The device does not have “on-board” patient and user management. If you
wish to manage seca patient files and user accounts, the device must be
connected to a PC on which the
the following connection options:
• network connection via
• indirect connection via USB memory stick
seca 115 PC software is installed. You have
seca 360° wireless network or Ethernet
Connecting the network via
Ethernet or seca 360° wireless
network
If the device is connected via seca 360° wireless network or Ethernet to a PC
on which the
seca 115 PC software is installed, you can directly access seca
patient files of the PC software and transmit newly-created seca patient files
directly to the PC software.
seca 115
NOTE:
• Information on creating and saving seca patient files can be found in
the section entitled “Assigning a measurement to a patient file” from
page 36.
• Follow the instructions for use for doctors and assistants for the
seca 115 PC software. If you have any queries regarding data con-
nections, contact your administrator.
20 •
English
seca 115
print
Printing If the device is connected to the seca 115 PC software via Ethernet, you can
use the specific printing function of the PC software and print out detailed
results reports on a PC printer.
You can start printing a results report directly from the Medical Body Composition Analyzer (see “Printing results report” on page 44). The data are trans-
Printer
mitted to the
connected PC printer.
seca 115 PC software and automatically passed on to the
NOTE:
• Analysis results are
the
seca 115 PC software for printing. To prevent data loss, follow
not saved automatically if they are transmitted to
the information in the section entitled “Saving the measured results”
on page 43.
• Follow the instructions for use for doctors and assistants for the
seca 115 PC software. If you have any queries regarding data
connections, contact your administrator.
Indirect connection via USB
memory stick
If the device is not to be directly integrated in a PC network, you can create
seca patient files and save measurements on the seca USB memory stick
supplied.
The seca USB memory stick is supplied initialized, meaning it contains a seca
patient database and is secured with an initial USB PIN (0000).
If you wish to use additional USB memory sticks (seca original accessories
recommended), these must also be initialized before seca patient files can be
saved on them. Contact your administrator for this.
You can synchronize the seca patient database on the USB memory stick
with the seca patient database of the
seca 115 PC software.
NOTE:
• Information on creating and saving seca patient files can be found in
the section entitled “Assigning a measurement to a patient file” from
page 36.
• Follow the instructions for use for doctors and assistants for the
seca 115 PC software. If you have any queries regarding data con-
nections, contact your administrator.
Before you really get started ... • 21
4.6 Operation using a seca 360° length measuring device
As an alternative to manual entry, you can also use a seca 360° length measuring device to determine height and transfer this to the device via
wireless network.
Height is taken into account when analyzing the bioimpedance measurement.
If the device is connected to the
seca patient file together with the other measured results and transmitted to
seca 115 PC software.
the
NOTE:
• Information on creating and saving seca patient files can be found in
the section entitled “Assigning a measurement to a patient file” from
page 36.
• Also follow the instructions for use for the
ing device. If you have any queries regarding data connections, contact your administrator.
seca 115 PC software, height is recorded in a
seca 360°
seca 360° length measur-
22 •
English
5. OPERATION
max. 180°!
max. 180°!
max.180°!
max.180°!
5.1 Operating concept
Swiveling the touchscreen display The touchscreen display of the device can be swiveled. As a result, it can be
perfectly positioned for every application.
► Swivel the touchscreen display so that is convenient for you to operate
and read.
NOTICE!
Damage to device
The swivel mechanism of the touchscreen display has an end stop.
Do not attempt to swivel the touchscreen display by more than 180°.
This will lead to mechanical damage to the housing and the internal
cabling.
► In every direction, only rotate the touchscreen display as far as the
end stop.
Switching on the device The device is switched on using the ON/OFF button. During the switch-on
procedure, the device performs a self-test. The self-test may take several
seconds.
1. Press the ON/OFF button briefly.
The LED of the button is white.
The internal PC of the device boots up. This takes several seconds.
The weighing function is available when the LED of the button is perma-
nently white and the
2. In the display, press the
The bioimpedance analysis function is available if the
message is no longer displayed and the
weight/height tab is shown in the display.
bia tab.
self-test active
module selection dialog window
appears.
The device is ready for operation.
Selecting functions Functions can be selected using the following elements of the touchscreen
display:
•tabs
• buttons
•drop-down menus
•checkboxes
► To select a function, press directly on the corresponding display element
(in this case: tabs, buttons).
Operation • 23
Selecting extended functions Functions commonly used in a certain context are accessible in the primary
menu. Additional functions are accessible in the secondary menu.
NOTE:
The assignment of functions to the primary and secondary menus is
specified at the factory and cannot be changed.
1. Press the
switch menu button.
The secondary menu is displayed.
2. Press the
switch menu button again.
The functions in the primary menu are shown again.
Entering text Text is entered via a computer keyboard shown on the touchscreen display.
1. Press an input field.
If the field is intended to have text entered in it, a computer keyboard
appears in the display.
2. Type in the desired text.
3. Press the Enter key on the keyboard.
The entry is accepted.
24 •
English
Display special characters Special characters can also be displayed with the computer keyboard.
1. Press and hold down any key on the computer keyboard (in this case “u”
key) .
All special characters are displayed in a context menu that is accessible
via the selected key (in this case four special characters available).
2. In the context menu, press the desired special character.
The special character appears in the input field.
3. Enter further text as usual.
Entering numbers Numbers are entered via a computer numerical keypad shown in the
touchscreen display.
.
1. Press an input field.
If the field is intended to have numbers entered in it, a numerical keypad
appears in the display.
2. Type in the desired number.
3. Press the Enter key on the numerical keypad.
The entry is accepted.
Operation • 25
Measuring procedure The operating concept is based on the typical measuring procedure outlined
below.
• Measure weight and height
• Perform a bioimpedance measurement
• Assign measurements to a seca patient file
• Evaluate measured results
• Save measuring procedure
The order of the tabs on the touchscreen display follows this sequence. It is
possible to operate in a different order.
NOTICE!
Loss of data
If there is no new entry for approx. 5 minutes, the current measurement is discarded. In this case, the complete measuring procedure
will have to be repeated.
► Save or print the measured results immediately after conclusion of
the measuring procedure (see “Closing the measuring procedure”
on page 43).
Automatic standby The device automatically switches to standby if there are no entries on the
device for 5 minutes. This has the following effects:
• measured results and settings which have not been saved are lost.
• the LED of the ON/OFF button is green.
• the touchscreen display goes out.
Switching off the device WARNING!
Electric shock
The device cannot be de-energized by pressing the ON/OFF button.
► Always take out the power supply plug if the device needs to be
de-energized - e. g. for a hygiene treatment.
► Press the ON/OFF button briefly.
The LED of the ON/OFF button is green. The touchscreen display goes
out. The device is on standby.
► Press and hold the ON/OFF button
The LED of the ON/OFF button goes out. The touchscreen display goes
out. The device is switched off.
NOTE:
When switching back on from standby, the device starts immediately
weight/height tab. When the device is switched on having been
in the
switched off, the internal PC boots up again. This takes several seconds.
26 •
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