Seca 525 User manual

Software version 1.0
seca 525
Instructions for Use

2 •
Instructions for use for seca 525. . . . . . . . . . . . 4
1. Device description . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Description of function . . . . . . . . . . . . . . . . . . . . 5
Device components . . . . . . . . . . . . . . . . . . . . 5
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . 5
Bioimpedance measurement . . . . . . . . . . . . . 5
Recording weight and height . . . . . . . . . . . . . 5
Administration of user accounts . . . . . . . . . . . 5
Administration of seca patient files . . . . . . . . . 6
Evaluating measured results . . . . . . . . . . . . . 6
Data transmission and network functions . . . . 6
Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 User qualification . . . . . . . . . . . . . . . . . . . . . . . . 6
Administration/network connection . . . . . . . . 6
Measuring mode . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . 7
2. Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Safety precautions in these Instructions for Use . 7
2.2 Basic safety precautions . . . . . . . . . . . . . . . . . . 8
Handling the device . . . . . . . . . . . . . . . . . . . . 8
Preventing electric shock . . . . . . . . . . . . . . . . 9
Preventing injuries and infections . . . . . . . . . . 9
Preventing device damage . . . . . . . . . . . . . . 10
Using the measured results . . . . . . . . . . . . . 10
Dealing with packaging material . . . . . . . . . . 11
2.3 Handling batteries and rechargeable batteries . 11
3. Device overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1 Monitor controls. . . . . . . . . . . . . . . . . . . . . . . . 12
3.2 Measuring mat controls . . . . . . . . . . . . . . . . . . 13
3.3 Login/navigation: buttons and symbols in the
touchscreen display. . . . . . . . . . . . . . . . . . . . . 14
3.4 Operating state: symbols . . . . . . . . . . . . . . . . . 15
Operating state: symbols in the touchscreen
display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operating state: symbols on the measuring
mat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5 Measuring mode: buttons and symbols . . . . . . 16
"patient" tab . . . . . . . . . . . . . . . . . . . . . . . . . 16
"measure" tab . . . . . . . . . . . . . . . . . . . . . . . 17
Measuring mat . . . . . . . . . . . . . . . . . . . . . . . 17
"evaluation" tab . . . . . . . . . . . . . . . . . . . . . . 18
3.6 Identification on the device and on the type plate 19
3.7 Identification on the packaging. . . . . . . . . . . . . 20
4. Making the device operational . . . . . . . . . . . . . . . 21
4.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . 21
4.2 Establishing power supply . . . . . . . . . . . . . . . . 21
4.3 Suspending measuring mat in storage
compartment. . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.4 Setting the date and time. . . . . . . . . . . . . . . . . 23
4.5 Charging rechargeable batteries . . . . . . . . . . . 24
4.6 Configuring the device . . . . . . . . . . . . . . . . . . . 24
Network functions . . . . . . . . . . . . . . . . . . . . 24
User role model . . . . . . . . . . . . . . . . . . . . . . 25
5. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.1 Switching system on/off. . . . . . . . . . . . . . . . . . 26
Switching on . . . . . . . . . . . . . . . . . . . . . . . . 26
Logging in . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Logging out/switching user . . . . . . . . . . . . . 28
Automatic standby . . . . . . . . . . . . . . . . . . . . 28
Switching the monitor to standby . . . . . . . . 28
Switching off . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2 Preparing seca patient file . . . . . . . . . . . . . . . . 29
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 29
Calling up seca patient file . . . . . . . . . . . . . . 29
Creating a seca patient file . . . . . . . . . . . . . . 30
Entering basic parameters . . . . . . . . . . . . . . 32
5.3 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . 34
Performing a measurement . . . . . . . . . . . . . 34
Performing offline measurement (WiFi not
available) . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Connecting the measuring mat . . . . . . . . . . 38
Canceling a measurement . . . . . . . . . . . . . . 38
5.4 Evaluating the measurement . . . . . . . . . . . . . . 39
Viewing the evaluation . . . . . . . . . . . . . . . . . 39
Viewing the history of an evaluation
parameter . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.3 Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
8. Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
9. What do I do if ...? . . . . . . . . . . . . . . . . . . . . . . . . . 44
9.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
9.2 Measuring mat. . . . . . . . . . . . . . . . . . . . . . . . . 44
9.3 Bioimpedance measurement . . . . . . . . . . . . . . 45
9.4 Data connection . . . . . . . . . . . . . . . . . . . . . . . 46
9.5 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
10. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
10.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
10.2 Measuring mat. . . . . . . . . . . . . . . . . . . . . . . . 48
10.3 Bioimpedance measurement . . . . . . . . . . . . . 48
Measuring method . . . . . . . . . . . . . . . . . . . . 48
Evaluation parameters . . . . . . . . . . . . . . . . . 49
Evaluation modules . . . . . . . . . . . . . . . . . . . 50
Clinical studies . . . . . . . . . . . . . . . . . . . . . . . 50
Accuracy of predictive formulas . . . . . . . . . . 51
10.4 seca 360° wireless system. . . . . . . . . . . . . . . 51
11. Optional accessories . . . . . . . . . . . . . . . . . . . . . . 52
12. Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
13.1 Measuring mat and device. . . . . . . . . . . . . . . 52
13.2 Batteries and rechargeable batteries . . . . . . . 52
14. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
CONTENTS

• 3
For administrators: configuring seca 525. . . . 54
1. Preparing configuration . . . . . . . . . . . . . . . . . . . . 54
2. Measuring mode . . . . . . . . . . . . . . . . . . . . . . . . . . 55
2.1 Administering the user database . . . . . . . . . . . 55
Setting up a user account . . . . . . . . . . . . . . 55
Editing a user account . . . . . . . . . . . . . . . . . 57
Deleting a user account . . . . . . . . . . . . . . . . 58
2.2 Administering the seca patient database . . . . . 58
Creating a seca patient file . . . . . . . . . . . . . . 59
Editing a seca patient file . . . . . . . . . . . . . . . 59
Deleting a seca patient file . . . . . . . . . . . . . . 59
Restoring a seca patient file . . . . . . . . . . . . . 60
2.3 Deactivating evaluation modules . . . . . . . . . . . 61
2.4 Modifying default settings. . . . . . . . . . . . . . . . . 62
Making regional settings . . . . . . . . . . . . . . . 62
Calibrating touchscreen display . . . . . . . . . . 63
Setting display brightness and volume . . . . . 64
2.5 Setting units of measurement. . . . . . . . . . . . . . 65
3. Data connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.1 Setting up LAN connection (stationary operation) 66
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 66
Setting up LAN connection . . . . . . . . . . . . . 66
Checking direct WiFi connection to measuring
mat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Deactivating/activating LAN . . . . . . . . . . . . . 67
3.2 Setting up WiFi connection (mobile operation) . 68
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 68
Setting up a WiFi connection . . . . . . . . . . . . 68
Deactivating/activating WiFi . . . . . . . . . . . . . 69
3.3 Setting up a connection to the seca analytics 115
PC software . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 70
Setting up PC connection on an automated
basis (UDP) . . . . . . . . . . . . . . . . . . . . . . . . . 70
Setting up PC connection manually . . . . . . . 71
3.4 Setting up the seca 360° wireless network . . . 72
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 72
Activating/deactivating the seca 360° wireless
module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Setting up a seca 360° wireless connection . 73
4. System data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.1 Synchronization and backup . . . . . . . . . . . . . . 74
Activating automatic synchronization . . . . . . 74
Setting up automatic export . . . . . . . . . . . . . 75
Exporting patient and user data manually . . 76
Restoring patient and user data manually . . 76
4.2 System information . . . . . . . . . . . . . . . . . . . . . 77
Viewing software versions . . . . . . . . . . . . . . 77
Updating software . . . . . . . . . . . . . . . . . . . . 77
Exporting the system log . . . . . . . . . . . . . . . 78
Resetting GUI . . . . . . . . . . . . . . . . . . . . . . . 79
4.3 Factory settings . . . . . . . . . . . . . . . . . . . . . . . . 80
Resetting device . . . . . . . . . . . . . . . . . . . . . 81
Enabling VNC access . . . . . . . . . . . . . . . . . 81
Declarations of conformity . . . . . . . . . . . . . . . 82
For USA and Canada: . . . . . . . . . . . . . . . . . 82
For Europe . . . . . . . . . . . . . . . . . . . . . . . . . 83

4 •
INSTRUCTIONS FOR USE FOR SECA 525
English
Software version: 1.0
Article number of this document: 17-10-05-350-002_12-2015 B
1. DEVICE DESCRIPTION
1.1 Intended use
The seca 525 medical Body Composition Analyzer is mainly used in hospitals,
medical practices and inpatient care facilities in accordance with national reg-
ulations. The medical Body Composition Analyzer seca 525 records weight,
height and bioelectric impedance measurements and automatically calculates
parameters such as fat-free mass (FFM) which can be derived from them. The
results are displayed in graphical form 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
The seca 525 is not a diagnostic device. To make an accurate diagnosis, the
physician needs to commission specific examinations and take their results
into account in addition to the results of the seca 525.
The device is not intended for use on children.
For North America: the device is intended for use on healthy individuals from
18 years of age upwards.
➔ Device description ➔ What do I do if ...?
➔ Safety precautions ➔ Technical data
➔ Device overview ➔ Optional accessories
➔ Making the device operational ➔ Spare parts
➔ Operation ➔ Disposal
➔ Hygiene treatment ➔ Warranty
➔ Function check ➔ Declarations of conformity
➔ Servicing ➔ For administrators: configuring
seca 525
➔ Intended use
➔ Description of function
➔ User qualification
➔ Contraindications

Device description • 5
English
1.2 Description of function
Device components The device consists of a monitor and a measuring mat.
The monitor is for administering patient and user data and for preparing and
evaluating bioimpedance measurements. The device is equipped with a
touchscreen display.
The monitor has a storage compartment with a magnetic catch for storing the
measuring mat.
The measuring mat is placed on the patient's legs for a bioimpedance mea-
surement. Measured results are transmitted to the monitor unit by WiFi. The
electrode cables of the measuring mat are equipped with connections for
push-button electrodes.
Power supply The monitor is powered by a connection to the electricity supply. The monitor
has a lithium-ion rechargeable battery to provide a mobile power supply.
The measuring mat is powered by a lithium-ion rechargeable battery. The
rechargeable battery is charged by an inductive charging interface in the stor-
age compartment of the monitor.
Bioimpedance measurement The bioimpedance measurement is carried out with the patient lying down,
using the 8-point method. The 4-point method (measuring the right half of
the body) is likewise possible. The low alternating current is provided and
impedance is measured by the electrode cables of the measuring mat. The
electrode cables are connected to two pairs of electrodes for each half of the
body. The electrodes are affixed to the patient's hands and feet.
Recording weight and height Scales and length measuring devices from the seca 360° wireless system can
transmit measured results to the device wirelessly. Alternatively, the patient's
weight and height can be recorded manually.
Administration of user accounts User accounts can be set up and administered directly on the device. The
user accounts for the device can be synchronized automatically with the user
accounts of the seca analytics 115 PC software. This allows access to both
the device and the PC software with the same user account.
➔ Device components
➔ Power supply
➔ Bioimpedance measurement
➔ Recording weight and height
➔ Administration of user accounts
➔ Administration of seca patient files
➔ Evaluating measured results
➔ Data transmission and network functions
➔ Compatibility

6 •
Administration of seca patient files Measured results are administered in seca patient files. seca patient files can
be created directly on the device. With administrator rights, seca patient files
can be edited directly on the device.
The device can be configured so that the seca patient files of the device are
automatically synchronized with the patient files of the seca analytics 115 PC
software.
seca patient files and seca patient databases contain exclusively data neces-
sary for working with seca products or which were determined using seca
products.
The export and import functions of the seca analytics 115 PC software can be
used for exchanging data with practice and hospital information systems.
Evaluating measured results Bioimpedance measurements are evaluated in graphical form based on sci-
entifically-validated formulas. In-house studies by seca generated predictive
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. Further studies generated normal ranges for
the following parameters: bioelectric impedance vector analysis (BIVA), mass
indices (FMI, FFMI), phase angle(φ), fat mass (FM) and skeletal muscle mass
(SMM).
Data transmission and network
functions
The device can be incorporated in a PC network via a LAN interface or
via WiFi. The device can thus communicate with the databases of
seca analytics 115 PC software and use the seca directprint function of
the seca analytics 115 PC software.
The monitor and the measuring mat communicate with one another via WiFi.
If WiFi is unavailable, the infrared interface in the storage compartment of the
monitor is used.
Scales and length measuring devices from the seca 360° wireless system can
transmit measured results to the device wirelessly.
Compatibility This device (software version 1.0) is compatible only with Version
1.4 build 381 or higher of the seca analytics 115 PC software. There is no
downward compatibility with older versions of the seca analytics 115.
1.3 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 and the seca analytics 115 PC software may only be operated by
persons with sufficient specialist expertise.
➔ Administration/network connection
➔ Measuring mode

Safety precautions • 7
English
1.4 Contraindications
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
2. SAFETY PRECAUTIONS
2.1 Safety precautions in these Instructions for Use
DANGER!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries will occur.
WARNING!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries may result.
CAUTION!
Used to identify a hazardous situation. If you fail to take note of this
information, minor to moderate injuries may result.
NOTICE!
Used to identify possible incorrect usage of the device. If you fail to
take note of this information, you may damage the device, or the mea-
sured results may be incorrect.
NOTE
Includes additional information about use of the device.
➔ Safety precautions in these Instructions for Use
➔ Basic safety precautions
➔ Handling batteries and rechargeable batteries

8 •
2.2 Basic safety precautions
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!
Patient hazard, damage to device
►Additional devices which are connected to electrical medical devic-
es must provide evidence of compliance with the relevant IEC or ISO
standards (e.g. IEC 60950 for data-processing devices). Further-
more, all configurations must comply with the requirements of stan-
dards for medical systems (see IEC 60601-1-1 or Section 16 of the
3rd edition of IEC 60601-1 respectively). Anyone connecting addi-
tional 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 at-
tention is drawn to the fact that local laws take precedence over the
above-mentioned requirements of standards. In the event of any
queries, please contact your local specialist dealer or Technical Ser-
vice.
►Please have servicing and BIA measuring technology checks per-
formed every two years.
►Technical modifications may not be made to the device. The device
does not contain any parts for servicing by the user. Only have ser-
vicing and repairs performed by an authorized seca service partner.
You can find service partners in your area at www.seca.com or by
sending an e-mail to [email protected].
►Only use original seca accessories and spare parts, otherwise seca
will not grant any warranty.
➔ Handling the device
➔ Preventing electric shock
➔ Preventing injuries and infections
➔ Preventing device damage
➔ Using the measured results
➔ Dealing with packaging material

Safety precautions • 9
English
CAUTION!
Patient hazard, malfunction
►Keep other electrical medical devices, e.g. high-frequency surgical
devices, a minimum distance of approx. 1 meter away to prevent in-
correct measurements or wireless transmission interference.
►Keep HF devices such as cell phones a minimum distance of ap-
prox. 1 meter away to prevent incorrect measurements or wireless
transmission interference.
►The actual transmission output of HF equipment may require mini-
mum 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 the electricity supply so
that the power supply socket is within easy reach and the power
supply can be disconnected quickly.
►Ensure that your local power supply matches the details on the de-
vice.
►Connect this device only to a power supply with a protective earth
facility.
►Do not connect the device to a power supply network if there is any
uncertainty about whether the protective earth is functioning. In this
case, use the device exclusively in rechargeable battery mode.
►Never touch the power supply cable with wet hands.
►Do not use extension cables or power strips.
►Make sure that cables are not pinched or damaged by sharp edges.
►Make sure that cables do not come into contact with hot objects.
►Do not operate the device at an altitude of more than 3000 m above
sea level.
Preventing injuries and infections WARNING!
Injury from falls
►Ensure that the device is positioned firmly and level.
►Route connecting cables (if present) in such a way that neither user
nor patient can trip over them.
WARNING!
Risk of infection
►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.

10 •
Preventing device damage NOTICE!
Damage to device
►Ensure that no liquids enter the device. They can damage the elec-
tronics.
►Switch off the device before you take the power supply connector
out of the power supply socket.
►If you are not going to use the device for an extended period, dis-
connect the power supply connector from the power supply socket
and remove the rechargeable battery (if present and removable).
Only then is the device de-energized.
►Make sure not to drop the device.
►Do not expose the device to any impacts or vibrations.
►Perform function controls regularly as described in the relevant sec-
tion in this document. Do not operate the device if it is damaged or
not working properly.
►Ensure that there is no heat source in the immediate vicinity. Do not
expose to direct sunlight. The excessive temperature could damage
the electronics.
►Avoid rapid temperature fluctuations. When the device is transport-
ed so that a temperature difference of more than 20 °C occurs, it
must stay turned off for at least 2 hours before it can be turned on
again. Otherwise, condensation water will form which can damage
the electronics.
►Use the device only in the ambient conditions outlined in "Intended
use".
►Store the device only in the storage conditions outlined in "Intended
use".
►Use only disinfectants free of chlorine and alcohol which are explic-
itly suitable for acrylic sheet and other sensitive surfaces (active in-
gredient: 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).
Using the measured results WARNING!
Patient hazard
This device is no diagnostic device. It simply assists the treating phy-
sician in establishing a diagnosis.
►In order to make a precise diagnosis and initiate therapeutic mea-
sures, besides determination of the weight, further targeted exam-
inations must be set up by the physician, and their results must be
considered.
►The responsibility for diagnosis and treatment lies with the treating
physician.
CAUTION!
Patient hazard
In order to avoid misinterpretations, test results for medical use must
be displayed and used in SI units (weight: kilogrammes, length:
metres) only. Some devices offer the ability to display test results in
other units. This is only an additional function.
►Use the results exclusively in SI units.
►The use of measurement results in non-SI units is the sole respon-
sibility of the user.