from software version 1.4
seca 115
Instructions for Use
for
Physicians and Assistants
English
CONTENTS
1. System description . . . . . . . . . . . . 4
1.1 Congratulations! . . . . . . . . . . . . 4
1.2 Intended use . . . . . . . . . . . . . . . 4
1.3 Description of function. . . . . . . . 5
Installation options . . . . . . . . . . . 5
seca mBCA data transmission. . 5
Transmission of data by seca
scales and stadiometers . . . . . . 6
Managing seca patient files . . . . 6
Recording weight and height . . . 6
Determining body composition . 6
Evaluation . . . . . . . . . . . . . . . . . 7
Administration of user data . . . . 7
Update of the PC software. . . . . 7
Compatibility with seca
measuring devices. . . . . . . . . . . 7
1.4 User qualification. . . . . . . . . . . . 8
Installation and administration . . 8
Measuring mode . . . . . . . . . . . . 8
2. Safety information . . . . . . . . . . . . . 8
2.1 Safety rules in the instructions
for use . . . . . . . . . . . . . . . . . . . . 8
2.2 Basic safety information. . . . . . . 8
Using the software. . . . . . . . . . . 8
Using measured results . . . . . . . 9
3. Overview . . . . . . . . . . . . . . . . . . . . 11
3.1 seca patient list . . . . . . . . . . . . 11
3.2 seca patient file . . . . . . . . . . . . 14
3.3 Color symbols and other
controls . . . . . . . . . . . . . . . . . . 15
3.4 Identification on the
packaging . . . . . . . . . . . . . . . . 16
4. Installation/updates . . . . . . . . . . . 16
5. Operation . . . . . . . . . . . . . . . . . . . 17
5.1 Starting/exiting program . . . . . 17
Opening the program. . . . . . . . 17
Logging off / switching user . . . 18
Exiting program . . . . . . . . . . . . 18
5.2 “Extras” menu . . . . . . . . . . . . . 18
Changing references . . . . . . . . 18
Creating user-specific
modules. . . . . . . . . . . . . . . . . . 20
Viewing measuring device
administration . . . . . . . . . . . . . 21
5.3 Working with the seca
patient list . . . . . . . . . . . . . . . . 23
Adjusting column width. . . . . . 23
Sorting column content in
ascending or descending
order. . . . . . . . . . . . . . . . . . . . 23
Showing and hiding columns . 24
Showing and hiding the seca
patient list from the USB
memory stick . . . . . . . . . . . . . 25
Searching for a seca patient
file. . . . . . . . . . . . . . . . . . . . . . 26
Creating a new seca patient
file. . . . . . . . . . . . . . . . . . . . . . 27
Sending seca patient file to a
seca mBCA . . . . . . . . . . . . . . 29
Copying seca patient files to
USB memory stick . . . . . . . . . 30
Importing seca patient files
from the USB memory stick . . 32
Exporting seca patient files
to .csv format . . . . . . . . . . . . . 33
Deleting individual seca
patient files . . . . . . . . . . . . . . . 35
Deleting all seca patient files . . 36
5.4 Working with the seca patient
file. . . . . . . . . . . . . . . . . . . . . . 37
Opening the seca patient file . . 37
Editing patient data. . . . . . . . . 37
Entering a medical history . . . . 38
Entering laboratory data . . . . . 40
Determining weight and
height . . . . . . . . . . . . . . . . . . . 42
Determining body composition
with a seca mBCA . . . . . . . . . 46
Assessing the examination
results. . . . . . . . . . . . . . . . . . . 47
Writing comments. . . . . . . . . . 56
5.5 Managing a seca patient file . . 57
Printing a seca patient file . . . . 57
Importing a patient file. . . . . . . 58
6. Medical basis. . . . . . . . . . . . . . . . 60
6.1 Evaluation modules. . . . . . . . . 60
2 •
English
Cardiometabolic risk . . . . . . . 61
Development/growth . . . . . . . 64
Energy . . . . . . . . . . . . . . . . . 66
Function/rehabilitation . . . . . . 68
Fluid. . . . . . . . . . . . . . . . . . . . 70
Health risk . . . . . . . . . . . . . . . 72
Raw data for impedance . . . . 74
6.2 References . . . . . . . . . . . . . . . 77
7. Technical information . . . . . . . . . 78
7.1 Technical modifications. . . . . . 78
7.2 Display of weight values . . . . . 79
8. Warranty. . . . . . . . . . . . . . . . . . . . 79
• 3
1. SYSTEM DESCRIPTION
1.1 Congratulations!
With the seca seca 115 PC software, you have
acquired a product from the
will assist you with the analysis and interpretation of
weight, height and bioimpedance measurements.
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.
1.2 Intended use
The seca 115 PC software is mainly used in hospitals,
medical practices and inpatient care facilities in accordance with national regulations.
seca 115 PC software is for administering weight,
The
height and bioimpedance measurements and for calculating automatically parameters which can be derived
from these measurements, e.g. FMI (fat mass index).
Results are displayed in graphical form and assist the
attending physician with the following medical issues:
• monitoring growth processes and weight changes
• determining energy expenditure and energy reserves
in order to assess weight changes and the course of
diseases as well as to provide dietary advice
• estimating cardiometabolic risk
• assessing metabolic activity and the success of a
training program, e.g. within the framework of
rehabilitation or physiotherapy
• determining the fluid status of a patient and
observing changes in fluids as the result of medical
treatment.
• determining general state of health or, in the case of
a previously-known disease, assessing its severity.
seca 115 PC software is not diagnostic software.
The
seca 360° system which
4 •
English
1.3 Description of function
Installation options The seca 115 PC software can be installed in the form
of a client/server solution or a standalone solution.
seca 115 PC software consists of the application
The
software and a seca patient database, together with
communication and evaluation modules.
For client/server operation, the application software is
installed on PC workstations (clients). The seca patient
database and the communication and evaluation modules are installed centrally on a server. All clients access
the server and use the seca patient database and communication and evaluation modules there.
For standalone operation, the application software, the
seca patient database and the communication and
evaluation modules are installed on the same PC
workstation.
seca mBCA data
transmission
seca medical Body Composition Analyzers (mBCAs)
have an Ethernet interface and can communicate with
seca 115 PC software in a network.
the
The network connection allows a seca mBCA to use
both the seca patient database and the special print
function of the
The special print function of the
makes it possible to start printing a results report
directly on a seca mBCA.
Alternatively to the Ethernet connection, seca mBCAs
and the
lessly via
seca 360° wireless USB adapter 456 must be con-
nected to a PC on which at least the seca 115 application software is installed.
seca 115 PC software.
seca 115 PC software
seca 115 PC software can communicate wire-
seca 360° technology. For this to happen, the
System description • 5
Transmission of data by
seca scales and
stadiometers
seca scales and stadiometers from the seca 360° system can communicate with one another wirelessly and
transmit data to the seca 115 PC software. For this to
happen, the
must be connected to a PC on which at least the
seca 115 application software is installed.
seca scales with an RS232 interface can transmit data
to the PC software by wired connection.
seca 360° wireless USB adapter 456
Managing seca patient
files
Recording weight and
height
seca patient files can be created in the seca 115 PC
software or on a seca mBCA. seca patient files are
saved in the seca patient database of the
software. Alternatively, seca patient files can be saved
on a USB memory stick. The USB memory stick has to
be “initialized” for this purpose.
“Initializing” is a
function allows the administrator to create an empty
seca patient database on a USB memory stick.
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 only be managed and edited using the
seca 115 PC software.
The export and import functions of the
software can be used for exchanging data with surgery
and hospital information systems.
On scales and stadiometers from the seca 360° system and on seca scales with an RS232 interface, it is
possible to start recording weight and height directly
from the
Measured results are sent from the
to the PC software. Alternatively, measured values can
be entered manually in the
seca 115 PC software function. This
seca 115 PC software.
seca 115 PC software.
seca 115 PC
seca 115 PC
seca 360° devices
Determining body
6 •
composition
Measurements with a seca mBCA (determines body
composition by means of bioimpedance measurement)
cannot be started from the
The results of a bioimpedance measurement are
assigned to a seca patient file directly on the
seca mBCA. The seca patient file is transmitted to the
seca patient database of the
seca 115 PC software.
seca 115 PC software.
English
The seca 115 PC software can only administer
bioimpedance measurements determined using a
seca mBCA.
Evaluation Measured results are evaluated in graphical form based
on scientifically-established formulas. In-house studies
by seca established formulas for determining the
parameters 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
these studies, in-house reference values were determined for the following parameters to allow normal
ranges to be shown: bioimpedance vector analysis
(BIVA), mass indices (FMI, FMMI), phase angle (φ).
Further information is available in the section entitled
“Medical basis” from page 60.
Administration of user
data
Update of the PC
software
Compatibility with seca
measuring devices
The following roles can be assigned to users of the
seca 115 PC software: physician, assistant or adminis-
trator. User accounts can only be set up or edited by
an administrator. A user name and password are
required for access to the
user account is set up for the seca 115 PC software,
the seca 115 PC software also generates a user PIN.
The user PIN allows access from a seca mBCA to the
seca patient database of the
When the PC software is updated, the seca patient
database and its contents are retained. The seca
patient database is adapted to suit the new version of
the PC software. After the update is complete, it will no
longer be possible to access the seca patient database
with older versions of the PC software.
Version 1.4 of the seca 115 PC software is compatible
only with seca mBCAs on which device software version 1.1 is installed. There is no downward compatibility with seca mBCAs on which older versions of the
device software are installed. For a summary of technical modifications, see the section entitled “Technical
modifications” on page 78.
seca 115 PC software has unlimited compatibility
The
with scales and stadiometers from the
tem and with seca scales with an RS232 interface.
seca 115 PC software. If a
seca 115 PC software.
seca 360° sys-
System description • 7
1.4 User qualification
Installation and
administration
The seca 115 PC software may only be installed and
administered by experienced administrators or hospital
technicians.
Measuring mode The seca 115 PC software may only be used by
persons with sufficient expertise.
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.
ATTENTION!
Identifies possibility of incorrect operation of the
product. If you fail to take note of this information, the device may be damaged or the measured results may be incorrect.
NOTE:
Includes additional information about use of the
product.
2.2 Basic safety information
Using the software ► Please take note of the information in these
instructions for use.
► Keep the instructions for use and the declaration of
conformity they include in a safe place. The instructions for use are a component of the PC software
and must be available at all times.
8 •
English
► Only install the seca 115 PC software on PCs
equipped with an antivirus program. Always keep
your antivirus program up to date to protect your
computer system from current and future malware.
The
seca 115 PC software is protected from manip-
ulation and was checked for malware at the time the
software was created.
► Use the seca 115 PC software only for the specified
intended use.
► Use only seca mBCAs, scales and stadiometers in
conjunction with the
► Keep other electrical medical devices, e.g. high-fre-
quency surgical devices, a minimum distance of
approx. 1 meter away to prevent incorrect measurements or wireless transmission interference.
► Keep high-frequency devices such as cell phones
and televisions, for example, a minimum distance of
approx. 1 meter away to prevent incorrect measurements 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.
Using measured results WARNING!
Hazard to patient
seca 115 is not diagnostic software. The device
assists the attending physician in producing a
diagnosis.
► To produce an accurate diagnosis and insti-
gate therapies, the attending physician must
commission specific examinations and take
account of their results in addition to using
the seca 115 PC software.
► 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 and this PC software,
seca 115 PC software.
Safety information • 9
too, have the option of displaying measured
results in different units. This is purely an
additional function.
► Only use measured results 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 measured results
in the
seca 115 PC software (e.g. in a hospital
information system), make sure that the measured values are plausible and that they correspond to the display on the measuring device.
• If measured values have been transmitted
from the
seca 115 PC software to a hospital
information system, make sure before re-use
that the measured values are plausible and
assigned to the correct patient.
10 •
English
3. OVERVIEW
13 6
78 12
54
14
13
2322
9
2
171615 19
2120
11
18
10
3.1 seca patient list
No. Control Function
1
File
2
3
Edit
Extras
The following functions can be accessed using this
menu element:
CSV export
•
• Exit
The following functions can be accessed using this
menu element (only with aseca patient file open):
Cut
•
• Copy
• Paste
Also as a context menu - right-click
The following functions can be accessed using this
menu element:
References
•
• User-specific modules
• Measuring device administration
Overview • 11
No. Control Function
The following functions can be accessed using this
menu element:
4
5
Registered user
6
7
8
9
10
11
12
Column sorting
send to mBCA Send seca patient file to a seca mBCA
Main patient list
Search window
13
14
copy to USB stick
15
16
17
Patient list on USB
18
?
[role]
Log off
new Create a new seca patient file in the main patient list
open Open a seca patient file in the main patient list
Checkbox
Selection bar
delete
select all
deselect all
memory stick
• Product information
• Instructions for Use
• Administrator manual
The following roles are provided:
•
Administrator
• Physician
• Assistant
Changes can only be made by users with the
Administrator role.
Open the login dialog (enter user name and
password) to log in another user
• Up arrow: sort from A - Z
• Down arrow: sort from Z - A
Displays seca patient files:
• data entered in the main patient list
• data imported from the USB memory stick
Search for seca patient files in the main patient list.
• “Asterisk search” - e.g. “Mi*” to find Miller
• Back to the complete list with empty search
• Activates a seca patient file.
• Clicking buttons in the seca patient list affects all
“activated” seca patient files.
Indicates which seca patient file is currently selected.
Clicking buttons has no effect on the selected file (cf.
“Checkbox”)
Copy seca patient files selected in the main patient
list to a USB memory stick, e.g. for use on an mBCA
Delete “activated” seca patient file
(seca patient file can be restored by users with the
Administrator role)
• Select all seca patient files in the main patient list in
order to carry out actions for all
• Deselect all seca patient files in the main patient list if
action for all has been carried out or if no action is to
be carried out
Displays seca patient files saved on a USB memory
stick
• seca patient files copied from the main patient list
• seca patient files newly created on an mBCA
12 •
English
No. Control Function
Show/hide patient
19
list from the USB
20
21
Search window
22
23
memory stick
Drive selection
window
delete
select all
deselect all
• seca patient list on the USB memory stick is
automatically shown at system start
• List can be hidden in order to display more entries in
the main patient list
For selecting the USB memory stick
Search seca patient files on the USB memory stick.
• “Asterisk search” - e.g. “Mi*” to find Miller
• Back to the complete list with empty search
Delete seca patient file on the USB memory stick
(seca patient file cannot be restored on the USB
memory stick)
• Select all seca patient files on the USB memory stick
in order to carry out actions for all
• Deselect all seca patient files on the USB memory
stick if action for all has been carried out or if no
action is to be carried out
Overview • 13
3.2 seca patient file
A
B
E
F
G
H
D
CI
J
L
K
A
B
C
D
E
patient data Enter, edit, and view the patient's master data
medical history Enter, edit, and view the patient's medical history
laboratory data
examination
F
G
H
I
14 •
Symbol Meaning
Patient info Summary of the most important patient data
results
comments Add and view comments about the seca patient file
measure
import
print Print results report or save as PDF
Enter, edit, and view the patient's laboratory data
Data can be imported if an interface to the hospital
information system is programmed
View examination results
• Start measuring process for weight and height
• Send seca patient file to a seca mBCA
Import patient data
Note: Configuration or programming of an interface to
the patient data management system (PDMS)
required
English
Symbol Meaning
J
K
L
save Save changes and additions to the seca patient file
close
Date/time Settings are adopted from the operating system
Close the seca patient file and return to the seca
patient list
3.3 Color symbols and other controls
Control/display Symbol Meaning
Tab
Typeface, evalua-
tion modules
Typeface,
measurements
Typeface, evalua-
tion parameters
Handles
Comments symbol
Detail symbol Detail view available for results graph
White: tab not selected
Red: tab selected
Red, with selection bar: module is active
Bold: new data available
Gray: module not available
Red, with selection bar: measurement
selected, details shown
Bold: new measurement
Parameter red: value outside normal
range
Selection of several measurements:
• drag left handle upwards: add
measurements of a more recent date.
• drag right handle downwards: add
measurements of an older date
Comment for evaluation parameters
present
Drop-down
triangles
Data transmission
Drop-down menu
Gray: function available
Light gray: function not available
Data transmission in progress
Data transmission successful
Data transmission failed
Selected function
Drop-down menu open
Overview • 15
Control/display Symbol Meaning
Checkboxes
Empty: function deactivated
Cross: function activated
3.4 Identification on the packaging
Text/symbol Meaning
Mod Model number
S/N Serial number
Follow instructions for use
Product complies with EC directives
0123
Name of manufacturer
Packaging material can be disposed of through recycling programs
Protect from moisture
Permitted min. and max. temperature for transport and storage
Permitted min. and max. moisture for transport and storage
4. INSTALLATION/UPDATES
The PC software may only be installed and updated by
experienced administrators or hospital technicians.
Information about the software version installed and
about the availability of updates can be found in the
menu line of the PC software at “
”.
16 •
information
For information about installation and configuration
options, check the menu line of the software under
? Î Administrator manual”.
“
In the event of questions about the system currently
installed on your PC and if you want to make any
changes, please contact your administrator.
? Î Product
English
ATTENTION!
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.
5. OPERATION
5.1 Starting/exiting program
Opening the program 1. Click “Start Î Programs Î seca Î seca medical
software”.
The login dialog opens.
2. Enter your user name.
3. Enter your password.
NOTE:
User name and password are created by the
administrator. If you want to change the user
name or password, please contact your
administrator.
Operation • 17
4. Confirm your entries with ok.
The seca patient list opens.
Logging off / switching
user
► Click on Log off.
The login dialog opens.
Another user can log in.
Exiting program ► Click on the cross symbol.
The program will close.
5.2 “Extras” menu
Changing references The seca 115 PC software evaluates measured results
using references. References are formulas and comparison values determined in clinical studies. During the
installation and configuration of the
ware, your administrator sets in which country you are
operating your
the references normally used in your country are preset
automatically.
You can change the preset references to suit the regulations applying in your institution and your personal
preferences. To do so, proceed as outlined below.
seca 115 PC software. With this setting,
seca 115 PC soft-
18 •
NOTE:
This section describes how to use the
PC software For information about the medical
content, see the section entitled “Medical basis”
from page 60.
1. From the Extras menu, select the References
element.
seca 115
English
The References dialog window opens.
2. Click on the arrow of the parameter for which you
want to select the reference.
A pull-down menu with all the selection options for
the reference opens.
3. Click the desired reference.
The pull-down menu closes.
The selected reference appears in the selection
field.
4. Repeat steps 2. and 3. for all parameters whose
references you would like to change.
5. To save the settings, click
ok.
The dialog window closes.
NOTE:
If you click on “Cancel”, the settings are not
saved.
Operation • 19
Creating user-specific
modules
A number of evaluation modules have already been set
up to assess your patient's state of health (see
“Evaluation modules” on page 60).
In the
User-specific modules dialog, you can compile
two further modules. You can view and evaluate these
in the seca patient file under the examination results
tab, just like the preset evaluation modules.
NOTE:
This section describes how to use the
seca 115
PC software For information about the medical
content, see the section entitled “Medical basis”
from page 60.
To compile a user-specific module, proceed as
outlined below.
1. In the
Extras menu, click on User-specific
modules
The
.
User-specific modules dialog window
appears.
Module 1 is preselected.
20 •
English
2. In the Module name field, enter the name you want
to give the module.
3. Click a maximum of 4 parameters you want
displayed in your module.
4. Click on ok.
The user-specific module is saved.
NOTE:
•With Cancel selection, you can deselect all
selected items with a mouse-click.
•With
Cancel, you can exit the dialog window
without saving settings.
• To delete a saved module, click on
selection
Module name field and click on ok.
, delete the module name in the
5. If desired, repeat the process for
Cancel
Module 2.
Viewing measuring
device administration
You can view which scales and stadiometers are
connected to your PC.
The following information is displayed for each seca
measuring device connected:
• device name if entered by the administrator
(recommended)
•model
• setup location if entered by the administrator
(recommended)
• serial number
• connection properties:
Connection Properties
Ethernet [IP address]:[port]
seca 360°wireless
network
[PC name : channel;
device type]
RS232 devices [PC name : COM port]
To have the measuring device configuration displayed,
proceed as outlined below.
1. From the
device administration
Extras menu, select the Measuring
element.
Operation • 21
The Measuring device administration window
appears.
NOTE:
You cannot make any changes in this window.
If changes are to be made, please contact your
administrator.
2. To exit the
Measuring device administration
window, click on close.
22 •
English
5.3 Working with the seca patient list
Adjusting column width 1. Position the mouse pointer in the title line on the line
between two columns.
The pointer turns into a double arrow.
2. Hold down the left mouse button and drag to make
the column wider or narrower.
3. Release the left mouse button once the required
column width is reached.
Sorting column content
in ascending or
descending order
1. Click in the title line of the desired column.
An arrow appears next to the column title, to
indicate the current sorting direction.
2. Click the arrow to re-sort column content.
3. To reverse the sorting direction, click the arrow
again.
Operation • 23
Showing and hiding
columns
1. Position the mouse pointer in the seca patient list.
2. Right-click.
A context menu with the titles of all columns
appears.
3. Click on the title of the column you want to hide.
The checkmark in front of the column title is no
longer displayed.
The corresponding column is hidden in the seca
patient list.
4. Click on the title of the column again to show it
again.
The checkmark in front of the column title is
displayed again.
The corresponding column is shown in the seca
patient list again.
24 •
English
Showing and hiding the
seca patient list from
the USB memory stick
The patient list from the USB memory stick is shown
each time the program starts. You can hide the patient
list from the USB memory stick to obtain more space
for the entries of the main patient list.
1. Click on the “
the USB memory stick.
The patient list from the USB memory stick is no
longer shown.
2. To show the patient list from the USB memory stick
again, click on the “-” symbol again.
-” symbol above the patient list from
Operation • 25
Searching for a seca
patient file
1. Enter a search term in the search field.
NOTE:
If you do not know exactly how to spell a name,
you can carry out a so-called “asterisk search” e.g. “Mi*” to find “Miller”.
2. Click the arrow next to the search field.
The search process starts.
The search results are displayed.
3. In order to return to the complete seca patient list,
delete the search term in the search field.
4. Click the arrow next to the search field.
The complete seca patient list is shown again.
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