Seca 515, 514 User manual

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Page 1

seca 515/514

Instructions for use

for

doctors and assistants

Software version 1.1

Page 2

English

CONTENTS

1. Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.2 Description of function. . . . . . . . . . . . . . . . . . . . . . 4

Recording weight and height . . . . . . . . . . . . . . . 4

Bioimpedance measurement . . . . . . . . . . . . . . . 4

Management of patient data. . . . . . . . . . . . . . . . 4

Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Management of user data. . . . . . . . . . . . . . . . . . 5

Data transmission and network functions . . . . . . 5

Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3 User qualification . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Administration/network connection. . . . . . . . . . . 5

Measuring mode . . . . . . . . . . . . . . . . . . . . . . . . 5

1.4 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

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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

Configurin

7.1 Adapting default module selection for

7.2 Saving settings . . . . . . . . . . . . . . . . . . . . . . . . . . 63

8. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

8.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

8.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

8.3 Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

9. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

10. Maintenance/subsequent verification

(verified model) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

g the device. . . . . . . . . . . . . . . . . . . . . . . . 61

bioimpedance analysis . . . . . . . . . . . . . . . . . . . . 61

Showing/hiding default module selection . . . . . 61

Creating default module selection. . . . . . . . . . . 62

Applying settings . . . . . . . . . . . . . . . . . . . . . . . 63

Exiting Settings\user menu. . . . . . . . . . . . . . . . 63

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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

18. Declaration of conformity . . . . . . . . . . . . . . . . . . . . 75

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1. DEVICE DESCRIPTION

1.1 Intended use

1.2 Description of function

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

Recording weight and height The device uses an electronic scale. Weight is recorded across 4 load cells.

Height is recorded via manual entry or via wireless transmission from a

seca 360° length measuring device.

Bioimpedance measurement Bioimpedance is measured according to the 8-point method. The flow of the

low alternating current and the measurement of impedance are performed for each side of the body using a pair of foot electrodes and 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.

Management of patient data seca patient files can be created directly on the device to manage measured

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 exchanging data with surgery and hospital information systems.

seca 115 PC software can be used for

seca 115 PC software.

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.

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English

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 seca 115, a user PIN is automatically generated for the

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 515/514.

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 can communicate wirelessly via

seca 360° wireless USB adapter 456 (included in the scope of delivery) must

seca 515/514.

seca 115 PC software

seca 360° technology. For this purpose, the

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

seca 115. For a summary of technical modifications, see the section

of the entitled “Technical modifications” on page 74.

1.3 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.

Device description • 5

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1.4 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

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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

Page 8

• 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.

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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

Page 10

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).

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3. OVERVIEW

Front

Rear

Rear of weighing platform

3.1 Controls

No. Control Function

To switch on the device: press button briefly

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

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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

Pair of hand electrodes, right

Spirit level Shows whether the device is horizontal

Pair of foot electrodes, right For heels and balls of feet, for bioimpedance measurement

Pair of foot electrodes, left For heels and balls of feet, for bioimpedance measurement

Pair of hand electrodes, left

Foot screws, right 2 pcs, for precise alignment of the device

Power pack connection For connecting the power pack

Ethernet interface For integrating the device in a PC network

Foot screws, left 2 pcs, for precise alignment of the device

• 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

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3.2 Symbols in the start display

Symbol Meaning

Header, remains unchanged in all menu levels and tabs. The following data are displayed:

•patient data

-name

-weight

-height

-BMI

• data connections

•date/time

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

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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)

• seca 360° wireless connection to PC using seca 115

• USB memory stick connected to device

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:

• 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

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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

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

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Control/display Symbol Meaning

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)

0102 0123

Follow instructions for use

Medical electrical device, type BF

Insulated device, protection class II

Value in mass units (verified models) Gives the difference between two consecutive display values Used to classify and verify a scale

Value in mass units (unverified models) Gives the difference between two consecutive display values

Weighing range (verified models)

Device complies with EC standards and directives.

• M: Conformity label according to Directive 2014/31/EU governing non-automatic weighing instruments (verified models)

16: (Example: 2016) Year in which the declaration of conformity was completed and the CE

• symbol was applied (verified model)

• 0102: Notified body metrology (verified models)

0123: Notified body medical products

•

Class III scale to Directive 2014/31/EU and OIML R76-1

16 •

Page 17

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

Page 18

4. BEFORE YOU REALLY GET STARTED ...

ghf

4.1 Scope of delivery

seca 115

User Docs

No. Component Pcs.

Medical Body Composition Analyzer (mBCA) 1

Power pack 1

DVD with seca 115 PC software and license for one permanent workplace 1

“User Documentation” DVD with user documentation in PDF format:

• instructions for use for doctors and assistants

• administrator manual

• additional information

Instructions for use for doctors and assistants, printed 1

seca 360° wireless USB adapter 456 1

seca USB memory stick, 2 GB, initialized (USB PIN: 0000) 1

Ethernet cable (1.5 m) for connecting to a TCP/IP network 1

515/514

seca

18 •

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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

Page 20

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.

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seca 115

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

Page 22

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 •

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5. OPERATION

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

Page 24

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.

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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

Page 26

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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5.2 Determining weight and height

NOTICE! Incorrect measurement due to force shunt

All the controls of the device are in the so-called weight-sensitive area. If you touch or lean on the device when measuring a patient, this will affect the measured results.

► During the measuring procedure, ensure that the device is only

touched by the patient who is currently being measured.

Starting the weighing procedure 1. Ensure that the device has no load.

2. Switch on the device. The LED of the ON/OFF button is white

3. Wait until the

weight/height tab is active.

WARNING! Injury from falling

The device is not designed as a standing aid.

► Assist persons with limited mobility when they are getting up, e.g.

from a wheelchair.

NOTE:

If you wish to perform a bioelectric impedance analysis directly thereafter, ensure that the patient steps on the scale with bare feet (see “Performing a bioimpedance measurement” on page 31).

4. Ask the patient to position themselves on the device. The weight display flashes. The hold value is determined automatically.

5. Wait until the weight display and the hold value are no longer flashing.

6. Read off the measured result.

NOTICE! Loss of data

If there is no new entry for approx. 5 minutes, the current measurement is discarded. The complete measuring procedure will have to be repeated.

NOTE:

When the patient steps off the device, the hold value will continue to be displayed. This enables you to attend to the patient before recording the weight. To delete the hold value, press the

hold button.

Operation • 27

Page 28

Manually determining hold value

(hold)

The device is equipped with an autohold function. During the measuring procedure, the weight is automatically frozen and the message “HOLD” is displayed in the window. It is possible that you will have to determine the hold value manually, e.g. if the patient removes an item of clothing after the initial weighing without stepping off the scale. In this case, proceed as outlined below.

1. Press the The display flashes until a stable weight is measured. The weight is then continuously displayed. The symbol is displayed (verified models

only).

2. Read off the measured result.

hold button.

NOTE:

When the patient steps off the device, the hold value will continue to be displayed. This enables you to attend to the patient before recording the weight. To delete the hold value, press the

hold button.

Taring off additional weight (tare) Using the tare function, you can prevent additional weight (e.g. a towel or a

mat on the weighing platform) from influencing the weighing result.

1. Switch on the device.

2. Place the additional weight on the device.

3. Press the The message “NET” appears on the display.

4. Ask the patient to position themselves on the device.

5. Read off the measured result. The additional weight is deducted automatically.

6. To deactivate the The “NET” message is no longer displayed.

tare button.

tare function, press the tare button again.

NOTE:

The maximum weight which can be displayed is reduced by the weight of the objects already placed on the scale.

Permanently storing additional

weight

(pre-tare)

Using the pre-tare function, you can permanently save an additional weight and automatically subtract this from a measurement result. For example, you can save a standard figure for clothing and then always deduct this if a patient is weighed fully-clothed. The pre-tare value is retained even after the device has been switched off.

1. Ensure that the device has no load.

2. Switch on the device.

3. Press the The numerical keypad appears. The last additional weight saved is displayed.

4. Enter a different pre-tare value if desired.

5. Press the Enter key on the numerical keypad. The entry is accepted. The message “PT” appears in the display. The value entered is saved and automatically subtracted from the

measurement result during the next weighing procedure. The numerical keypad is no longer displayed.

pre-tare button.

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Activating/deactivating pre-tare

function

Entering height manually To enter height manually, to determine BMI for example, proceed as outlined

If you wish to have a permanently-saved additional weight automatically subtracted from the measurement result during the current weighing procedure, proceed as outlined below.

1. Switch on the device.

2. Ask the patient to position themselves on the device.

3. Press the pre-tare button. The numerical keypad appears. The last additional weight saved is displayed.

4. Press the Enter key on the numerical keypad. The entry is accepted. The message “PT” appears on the display The displayed value is automatically subtracted from the measurement result. The numerical keypad is no longer displayed.

5. Read off the measured result.

6. To deactivate the

pre-tare function, press the pre-tare button again.

The additional weight is added to the measured result once more.

below.

1. Ensure that the

2. Press the

weight/height tab is active.

height field.

The numerical keypad appears.

3. Enter the patient's height.

Transmitting height via seca 360°

wireless network

4. Press the Enter key on the numerical keypad. The entry is accepted.

If the device is connected to a seca 360° length measuring device, you can transmit height, for determining BMI for example, to the

seca 360° wireless network. To do so, proceed as outlined below.

1. Ensure that there is a

seca 360° wireless connection.

seca 515/514 via the

The wireless symbol for the length measuring device is shown in white.

NOTE:

If you are uncertain of whether there is a

seca 360° wireless

connection, contact your administrator or hospital technician.

2. Switch on the length measuring device.

3. Perform the height measurement.

4. Ensure that the weight/height tab is active in the touchscreen display of the seca 515/514.

5. Press the send/print button on the length measuring device.

The measured value appears in the height field.

Operation • 29

Page 30

Calculating BMI automatically To determine BMI, you have to record the patient's height as well as their

weight.

► After weighing, enter the patient's height.

– Manually (see “Entering height manually” on page 29) –Via the

The BMI is calculated and displayed automatically.

seca 360° wireless network (see “Transmitting height via

seca 360° wireless network” on page 29)

Switching weighing range

automatically

The scale has 2 weighing ranges. In weighing range 1, there is a low maximum capacity and the increments of the weight display are more precise. In weighing range 2, you can use the maximum capacity of the scale.

After the scale is switched on, weighing range 1 is active. If a particular weight is exceeded, the scale automatically switches to weighing range 2.

To switch back to weighing range 1, proceed as outlined below.

► Completely remove the load from the scale.

Weighing range 1 is active again.

Printing partial results You can print out the measured results so far. Proceed as described in the

section entitled “Printing results report” on page 44.

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5.3 Performing a bioimpedance measurement

Switching on the device 1. Ensure that the device has no load.

2. Press the ON/OFF button. The start screen appears. The

weight/height tab is active.

Determining weight and height ► Determine weight and height as described in the section entitled

“Determining weight and height” from page 27.

Checking module selection

1. Activate the bia tab. Bioimpedance analysis is available when the message “Self-test running” is no longer displayed. If the device is configured accordingly (see “Configuring the device” on

page 61), the

impedance

module selection dialog window appears. The Raw data for

evaluation module is deactivated at the factory.

Activation/deactivation of the

risk

evaluation modules affects bioimpedance analysis as outlined in the

Raw data for impedance, Energy and Health

table below.

Evaluation

module

Setting

• = activated,

- = deactivated

Effect

• Physical activity level (PAL) is interrogated

Energy

No interrogation of physical activity level (PAL)

• Waist circumference (WC) is interrogated

Health risk

No interrogation of waist circumference (WC)

- Measurement duration: 20 seconds

Raw data for impedance

•

Measurement duration: 75 seconds Raw data for impedance available for 19 frequencies

a.Interrogation of PAL and WC in the Module-specific entries dialog window.

Dialog window is skipped if the Energy are deactivated.

and Health risk evaluation modules

2. Check the module selection.

Operation • 31

Page 32

3. Deactivate the modules for which you do not require evaluation.

Back

foot electrode

Front

foot electrode

Finger spacer

4. Press the

continue button.

Starting measurement 1. State whether the patient belongs to a group of people for whom a

bioimpedance measurement may not be performed.

– Yes: the measurement is not performed. The weight/height tab is

active again.

–

No: the procedure continues. The dialog window for positioning the

patient appears.

WARNING! Hazard to patient

Diseases can be transmitted by poor hygiene.

► Ensure that the patient does not have any contagious diseases.

► Ensure that the patient’s hands and feet are clean.

► Ensure that the patient does not have any open wounds on the

palms of their hands or the soles of their feet.

► Disinfect the electrode surfaces after every measurement.

WARNING! Injury from falling

The device is not designed as a standing aid.

► Assist persons with limited mobility when they are getting up, e.g.

from a wheelchair.

2. Ask the patient to position themselves on the device.

32 •

3. Ensure that the patient is standing on the device correctly.

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Test point Characteristics

• Hands must be clean

• Same pair of hand electrodes on left and right

Hands

• Select the pair of hand electrodes such that arms are extended but not under strain

• Finger spacers of the hand electrodes between the middle finger and ring finger on both sides

• Stand on device with bare feet

Feet

• Feet must be clean

• Heels on the rear foot electrodes

• Balls of feet on the front foot electrodes

• Upright position

Position

• Knees slightly bent

• Do not move during the measurement

4. Ensure that the patient is in good contact with the hand and foot electrodes.

If the patient is not in correct contact with an electrode pair, the corresponding electrode indicator on the touchscreen display will be red.

If the patient is in correct contact with an electrode pair, the corresponding electrode indicator on the touchscreen display will be green.

NOTE

• The selection of hand electrode influences the measurement result. Note the pairs of hand electrodes selected by the patient. In this way, you can ensure that the patient can use the same pairs of hand electrodes for future measurements.

• The electric current passed through the body during the measurement is very low and does not present any health risk. However, in isolated cases, very sensitive persons may feel a slight tingling sensation.

As soon as all the electrode indicators on the touchscreen display are green, a countdown to the start of measurement appears. Measurement starts automatically.

Operation • 33

Page 34

Remaining measurement time is displayed.

Screen still missing.

As soon as the measurement ends, the message appears.

5. Press the continue button.

End of measurement

34 •

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Entering PAL value and waist

circumference

The Module-specific entries dialog window appears once the bioimpedance measurement is complete. This is where you enter PAL value (PAL = physical activity level) and the patient's waist circumference. The PAL value is required to determine total energy expenditure (

Energy evaluation module). Waist cir-

cumference is required to determine the proportion of visceral adipose tissue

Health risk evaluation module).

(

NOTE:

If one of the module-specific entries has not been interrogated or the

Module-specific entries dialog window does not appear at all, the

associated evaluation modules have been deactivated (see “Starting measurement” on page 32 or “Adapting default module selection for bioimpedance analysis” on page 61).

1. Press the information button next to the PAL input field.

A list with typical PAL values and brief descriptions appears.

2. Press the suitable PAL value for your patient. The list is closed. The value appears in the input field.

3. Press the input field for waist circumference. The numerical keypad appears.

4. Enter waist circumference on the numerical keypad.

5. Press the Enter key on the numerical keypad. The value appears in the input field.

6. Press the

confirm button.

– If you have not yet measured weight and height, the

tab is active.

– If you have not yet assigned a seca patient file, the

active.

– If all data are available, the

analysis tab is active.

weight/height

patient tab is

Operation • 35

Page 36

NOTICE! Loss of data

If there is no new entry for approx. 5 minutes, the current measurement is discarded. The complete measuring procedure will have to be repeated.

Printing partial results You can print out the measured results so far. Proceed as described in the

section entitled “Printing results report” on page 44.

5.4 Assigning a measurement to a patient file

Checking data connection ► Ensure that you can access a seca patient database in one of the

following ways:

– the P C w ith th e

to the device via the corresponding data connection symbol is white.

– the USB memory stick with the seca patient database is connected

to the USB interface of the touchscreen display. The corresponding data connection symbol is white.

NOTE:

• If you have connected a USB memory stick containing a seca patient database to the device, you will not be able to access the

seca 360° patient database of the seca 115 PC software via Ethernet

or seca wireless network.

• If you are uncertain as to how a seca patient database can be accessed, contact your administrator or hospital technician.

seca 115 PC software is switched on and connected

seca 360° wireless network or Ethernet. The

Logging on to a seca patient

database

If you wish to search for or create seca patient files for the first time after switching on the device, the device will require you to authenticate yourself using your user PIN. For this purpose, proceed as outlined below.

1. Enter your user PIN using the numerical keypad.

NOTE:

If you do not have your user PIN to hand, or if you have questions regarding access rights, contact your administrator or hospital technician.

2. Press the Enter key on the numerical keypad. The entry is accepted. The device now accesses the seca patient database.

The login symbol is white. You are logged in to the seca patient database.

36 •

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NOTICE! Data access by unauthorized persons

If you are logged in to a patient database, unauthorized persons can also access seca patient files as long as the device is switched on.

► Do not leave the device unsupervised if you are logged in to a

patient database.

► Log off the patient database if you need to leave the device

unsupervised (see “Logging off from a seca patient database” on page 44).

► Switch off the device if you are not using it for an extended period.

Searching for a seca patient file To search for seca patient files, proceed as outlined below.

1. Press the

patient tab.

The input screen for the patient search appears.

2. Enter at least the one of the following items of data:

–patient ID – date of birth –name

NOTE:

It is possible to perform a wildcard search for patient names (e.g. Br* for Brown).

3. Press the

Search button.

NOTE:

If you are not logged in to a seca patient database, a dialog window appears for user PIN entry. Enter your user PIN as described in the section entitled “Logging on to a seca patient database” on page 36.

The device accesses the seca patient database (in this case: in the

seca 115 PC software via Ethernet). The search may take a few seconds.

Operation • 37

Page 38

All patients who meet the search criterion are displayed.

4. Press the desired entry.

The patient details are displayed.

5. Ensure that you have selected the correct patient.

NOTE:

• If you wish to perform a new patient search, press the new patient button.

• If you wish to return to the results list, press the

cancel button. If the

results list has only one entry, the search screen appears.

6. Press the

confirm button.

38 •

The current measurement is assigned to the selected seca patient file. The name of the patient appears in the header of the touchscreen display.

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English

NOTICE! Loss of data

The measurement has now been assigned to a seca patient file, but has not yet been saved. If there is no new entry for approx. 5 minutes, the device switches to standby. The seca patient file is no longer available on the device. The current measurement is discarded. The complete process will have to be repeated.

► Save the measurement as described in the section entitled “Closing

the measuring procedure” from page 43.

Providing a seca patient file from

the PC software

As an alternative to searching directly on the device, you can also send a seca patient file to the device from the seca 115 PC software.

NOTE:

This function is only available if you have an Ethernet network connection available.

1. Perform the measurements as described in sections “Determining weight and height” from page 27 and “Performing a bioimpedance measurement” from page 31.

2. Press the

3. Start the

4. Perform the following steps in the

patient tab on the device.

seca 115 PC software.

seca 115 PC software:

– select seca patient file –click on

send to mBCA

– select the seca mBCA to which the seca patient file is to be sent –click

send patient file

The seca patient file is transmitted to the seca mBCA by the PC software and appears in the

patient tab.

5. Ensure that the correct seca patient file is displayed.

6. Press the

confirm button on the device.

The name of the patient appears in the header of the touchscreen display. The measurement is assigned to the seca patient file.

NOTICE! Loss of data

► Save the measurement as described in the section entitled “Closing

the measuring procedure” from page 43.

Operation • 39

Page 40

Creating a new seca patient file 1. Press the patient tab.

The input screen for the patient search appears.

2. Press the

The device accesses the seca patient database (in this case: in the

seca 115 PC software via Ethernet).

Create button.

NOTE:

If you are not logged in to a seca patient database, the dialog window for entering your user PIN appears. Enter your user PIN as described in the section entitled “Logging on to a seca patient database” on page 36.

40 •

The initial input screen for patient data (mandatory fields) appears.

3. Enter the following patient data:

– date of birth –gender –ethnicity

NOTE:

You can find information regarding the influence of ethnicity on the evaluation of a bioimpedance analysis in the section entitled “Medical basis” from page 45.

4. Press the

continue button.

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English

The second input screen for patient data (optional fields) appears.

5. Enter the following patient data:

–First name – Surname –Patient ID

NOTE:

You only need to enter a patient ID if this has to follow a specific structure in your institution. If you do not enter an ID, then an ID will be assigned automatically when the data are saved.

6. Press the

confirm button.

A summary of the patient data is shown.

7. Press the

confirm button again.

The patient data are saved.

Editing patient data You cannot make changes to patient data directly on the device. If you dis-

cover that patient data need to be changed, make the changes using the

seca 115 PC software. For further information, see the user documentation for

the seca 115 PC software.

Operation • 41

Page 42

5.5 Viewing analyses

NOTE:

This section describes navigation in the

analysis tab. For information

about the medical content of the evaluation modules, see the section entitled “Medical basis” from page 45.

1. Press the analysis tab. The

Examination results dialog window appears.

The results for the first evaluation module (in this case:

rehabilitation

) are displayed.

Function/

2. For graphical analysis of individual results, press the drop-down triangle

▼ in the corresponding line.

The graphical analysis appears:

3. To close the graphical analysis, press the

X button.

4. To see the results of the other modules selected, press the drop-down menu.

42 •

Page 43

English

The drop-down menu opens.

5. Press the evaluation module you wish to view.

5.6 Closing the measuring procedure

Saving the measured results 1. Ensure that you can access a seca patient database in one of the

following ways:

2. Press the switch menu button.

The secondary menu appears.

3. Press the save button.

4. Log off from the seca patient database as described in the section entitled “Logging off from a seca patient database” on page 44.

The measuring procedure is complete.

– the P C w ith th e

to the device via the

seca 115 PC software is switched on and connected

seca 360° wireless network or Ethernet. The

corresponding data connection symbol is white.

– the USB memory stick with the seca patient database is connected

to the USB interface of the touchscreen display. The corresponding data connection symbol is white.

NOTE:

• If you have connected a USB memory stick to the device, you will not be able access the data of the Ethernet or the

seca 360° wireless network.

seca 115 PC software via

• If you are uncertain as to how a seca patient database can be accessed, contact your administrator or hospital technician.

– If you are logged in to a seca patient database, the measured results

will be saved. The corresponding data connection symbol is red.

– If you are not logged in to a seca patient database, the dialog win-

dow for user PIN entry appears. Enter your user PIN as described in the section entitled “Logging on to a seca patient database” on page 36. The measured results are saved. The corresponding data connection symbol is red.

Operation • 43

Page 44

Printing results report If the device is connected to a PC printer via seca 115, you can start printing

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out a results report directly on the device.

If the measurement is not assigned to any seca patient file, an anonymous results report is compiled.

1. Ensure that there is a network connection ( or Ethernet).

The corresponding symbol on the touchscreen display is white.

NOTE:

If you are uncertain of whether there is a network connection, contact your administrator or hospital technician.

2. Ensure that the PC and PC printer are switched on.

The printer symbol on the touchscreen display is white.

seca 360° wireless connection

Logging off from a seca patient

database

3. Press the

switch menu button.

The secondary menu appears.

4. Press the

print button.

The results report is compiled and printed. The printer symbol is red.

To log off from a seca patient database, proceed as outlined below.

NOTICE! Loss of data

If you log off without saving the measuring procedure, all data in the current measuring procedure will be lost.

► Save the current measurement before logging off from a seca

patient database (see “Saving the measured results” on page 43).

1. Press the

switch menu button.

The secondary menu appears.

2. Press the

log off button.

The login symbol is grayed out. You have been logged off from the seca patient database.

44 •

Page 45

English

6. MEDICAL BASIS

Air displacement plethysmography (ADP)

Dual energy X-ray absorptiometry (DEXA)

This section briefly describes the principles of bioimpedance analysis, as well as the content and medical objectives of the evaluation modules pre-set in this device.

For additional information, we refer you to the appropriate professional literature.

6.1 Bioimpedance analysis (BIA)

Classic body composition analysis The current “gold standard” for body composition analysis comprises a com-

bination of methods, some of which are highly technical and very time-consuming, for determining individual parameters. The parameters are considered in combination with the weight and height of the patient. This allows the nutritional condition and health risk of the patient to be assessed on an individual basis. The table below provides an overview of the gold standard parameters and the corresponding determination method.

Parameter Method

Total body water (TBW) Dilution method, tracer: deuterium

Test chamber

Reference chamber

Electronics

High pressure

Window

Low pressure

Diaphragm

Computer

Scale

High

Low

pressure

Moving diaphragm produces complementary pressure changes in the chambers

Extracellular water (ECW) Dilution method, tracer: sodium bromide

Calculation based on the four-component

Fat mass (FM)

model

from the variables: body volume,

bone minerals, weight and total body water.

Visceral adipose tissue (VAT)

Magnetic resonance tomography (MRT)

Fat-free mass (FFM) Difference between weight and fat mass

Skeletal muscle mass (SMM)

a.Fuller NJ, Jebb SA, Laskey MA, Coward WA, Elia M. Four-component model

for the assessment of body composition in humans: comparison with alternative methods, and evaluation of the density and hydration of fat-free mass. Clin Sci 1992; 82: 687-693.

Magnetic resonance tomography (MRT)

A high degree of technical complexity is required to determine fat mass. The table below serves as an overview of this also.

Parameter Method

Total body water (TBW) Dilution method, tracer: deuterium

Body volume

Densitometry, e.g. air displacement plethysmography (ADP)

Bone minerals Dual energy X-ray absorptiometry (DEXA)

The high technical and financial outlay, combined with considerable time and space requirements, mean that the “gold standard” is unsuitable for day-today operations in clinics and medical practices.

Medical basis • 45

Page 46

Functional principle of

Equivalent circuit diagram:

measurement of total body impedance

seca 515/514:

measurement of total body impedance

bioimpedance analysis

Bioimpedance analysis is a method for rapid, simple and non-invasive assessment of body composition. Only one measuring procedure on a single device is required.

In a bioimpedance analysis, the human body is regarded as an electrical conductor in an alternating current circuit and its alternating current resistance (impedance) is measured.

The following properties of an electrical conductor have an impact on its impedance:

Property Correspondence in humans

Length Height

Cross-section E.g. waist circumference

Material Body water, cell tissue

When it comes to the human body, age, gender, physical fitness and ethnicity also have an impact on impedance.

In the event that a low alternating current is conducted into the body via electrodes on the arms and legs and the voltage drop is measured via a second electrode pair in each case, the components of body impedance below can be determined.

Impedance component Cause

Resistance (R), ohmic resistance

Reactance (X

), capacitive

resistance

Body water is a good electrical conductor

Cell tissue acts as a capacitor

Phase shift between the maximum current

Phase angle (φ)

and maximum voltage as a result of the capacitor effect of the cell tissue

Pioneering achievement: seca

formulas

If the alternating current is applied at different frequencies, individual parameters can be specifically determined. In this way, for example, the proportion of extracellular water can be determined directly if low frequencies of between 2 and 5 kHz are used. Alternating current at these frequencies is hardly able to penetrate cell walls. Cell walls and intracellular water therefore have a very minor impact on impedance.

Using the measured parameters in combination with the weight, height, age, and gender of a patient, the body composition of the patient can be determined and then assessed. The pre-requisite in this case are formulas calculated according to scientific criteria.

A number of formulas are already available from a number of sources which can be used to determine body composition on the basis of R, X

, weight,

height, age and gender of a patient. The formulas are based on results of what are referred to as validation studies compared to reference methods of the gold standard, such as air displacement plethysmography (ADP) or dual energy X-ray absorptiometry (DEXA), for example.

However, the comparability and accuracy of these formulas must be regarded with a critical eye, as the validation studies were performed with differing reference methods and, in all respects, heterogeneous reference populations. In addition, the study results cannot necessarily be transferred to other manufacturers’ devices for technical reasons.

46 •

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seca therefore developed its own predictive formulas for determining the following parameters for the arms and legs:

• total body water (TBW)

• extracellular water (ECW)

• fat-free mass (FFM)

• skeletal muscle mass (SMM) for arms, legs, torso and whole body

In-house reference values were determined for the following parameters in order to be able to show normal ranges:

• bioimpedance vector analysis (BIVA)

• mass indices (FMI, FFMI)

• phase angle (φ)

In order to determine the formulas and reference values, there was close collaboration with the Institute for Human Nutrition and Food Studies at the University of Kiel and joint representative studies were conducted.

In contrast to all formulas published to date, the seca formulas are population-specific. The formulas developed in Kiel apply solely to Caucasian population groups.

Representative surveys were also conducted in the USA in collaboration with the New York Obesity Nutrition Research Center at St. Luke’s Roosevelt Hospital. seca formulas for African-American, South/Central American and Asian population groups were developed on the basis of this study.

The seca formulas are implemented only in seca mBCA devices and seca PC software. As such, seca is a pioneer in the well-founded scientific and medically significant determination of body composition by means of bioimpedance analysis.

6.2 Evaluation parameters

Summary of evaluation parameters With seca, the parameters required for assessing body composition are

called evaluation parameters. The table provides an overview of the evaluation parameters of the seca 515/514.

seca 115 PC software, the evaluation parameters are

Evaluation parameter

Bioimpedance vector analysis (BIVA)

Body mass index (BMI)

Extracellular water (ECW)

Fat-free mass (FFM)

Fat mass (FM)

On the device and in the grouped into evaluation modules. This allows certain aspects of body composition to be assessed specifically (see "Evaluation modules" from page 50).

Display Evaluation module

• Normal range display of R and X co-ordinate system in relation to height

• 50 %, 75 %, 95 % percentiles in the

• “Fluid” from page 56

• “Health risk” from page 57

form of tolerance ellipses

•Absolute in kg/m

• For children: shown in percentile curves

• For adults: graphic display of WHO

“Development/growth” from page 50

reference values

Absolute in l “Fluid” from page 56

Absolute in kg “Function/rehabilitation” from page 54

•Absolute in kg

• Relative in %

• For adults: normal range display

• “Energy” from page 53

• “Function/rehabilitation” from page 54

Medical basis • 47

Page 48

Evaluation parameter

Display Evaluation module

Total energy expenditure

Absolute in MJ/d or kcal/d “Energy” from page 53

(TEE)

Total body water (TBW)

Weight (W)

Height (H)

Hydration (HYD)

Energy stored in body (E

body

Absolute in l “Fluid” from page 56

•Absolute in kg

• For children: shown in percentile curves

•Absolute in m

• For children: shown in percentile curves

“Development/growth” from page 50

Relative in % “Fluid” from page 56

Absolute in MJ or kcal “Energy” from page 53

)

Impedance (Z) Absolute in ohms “Raw data for impedance” from page 59

BCC: mass indices fat-free mass index (FFMI) fat mass index (FMI)

Phase angle (φ)

•Absolute in kg/m

• Normal range display in co-ordinate system in relation to height

• 50 %, 75 %, 95 % percentiles in the form of tolerance ellipses

• Absolute in degrees

• Normal range display according to seca reference values with percentile curves

• “Function/rehabilitation” from page 54

• “Health risk” from page 57

• “Raw data for impedance” from page 59

• “Fluid” from page 56

Reactance (X

) Absolute in ohms

• “Health risk” from page 57

• “Raw data for impedance” from page 59

• “Fluid” from page 56

Resistance (R) Absolute in ohms

• “Health risk” from page 57

• “Raw data for impedance” from page 59

Resting energy expenditure

Absolute in MJ/d or kcal/d “Energy” from page 53

(REE)

Skeletal muscle mass

Absolute in kg “Function/rehabilitation” from page 54

(SMM)

Visceral adipose tissue

Absolute in l “Health risk” from page 57

(VAT)

48 •

Page 49

English

seca specialty: co-ordinate system

Z(FMI)

Z(FMMI)

95th

75th

50th

II I

IVIII

with tolerance ellipses

II I

Z(Xc)

95th

75th

50th

Z(R)

IVIII

In addition to the classic display of evaluation parameters in numerical values, bar graphs and percentile curves, the

seca 515/514 uses co-ordinate systems

with so-called tolerance ellipses for the graphical display of body impedance and fat-mass indices.

This form of graphical display, named “bioimpedance vector analysis” (BIVA), was developed by Professor A. Piccoli for the interpretation of body impedance.

The transfer of this principle to the display and interpretation of fat mass indices, on the other hand, is a new development by seca in collaboration with the Institute for Human Nutrition and Food Studies at the University of Kiel.

Bioimpedance vector analysis (BIVA)

Professor A. Piccoli's BIVA is a graphical representation of the electrical resistances of the body. To this end, the impedance of the patient is displayed as a measurement point in a co-ordinate system: capacitive resistance (X

) on the y axis, ohmic resistance (R) on the x axis. Both variables Xc and R are considered relative to height (length of the electrical conductor).

With vector display, a test subject can be investigated simultaneously with regard to his/her total body water – R – and his/her body cell mass – X

Changes to the measurement point (R, Xc) parallel to the x axis indicate changes to fluid volume, whilst changes on the y axis indicate an increase or decrease in body cell mass.

The quadrants in the co-ordinate system are named correspondingly:

high, R high = decreasing proportion of water

•I: X

• II: X

• III: X

•IV: X

low, R high = increasing body cell mass

low, R low = increasing proportion of water

high, R low = decreasing body cell mass

An additional advantage of BIVA is the comparison of an individual measured value to reference values. The 50 %, 75 % and 95 % percentiles are entered in the co-ordinate system in the form of tolerance ellipses.

Fat mass indices (FFMI and FMI)

The system developed by Professor A. Piccoli can also be applied to representation of the fat mass indices on the basis of work conducted by Schultz et al., who describe four typical situations for the relationship of FFMI and FMI.

The quadrants in the co-ordinate system are named correspondingly:

• I: FFMI high, FMI high = increasing obesity

• II: FFMI low, FMI high = increasing sarcopenic obesity

• III: FFMI low, FMI low = increasing thinness

• IV: FFMI high, FMI low = increasing skeletal muscle mass

In addition, the FFMI (x axis) and the FMI (y axis) are also plotted for FFMI and FMI on the axes of the co-ordinate system. The 50 %, 75 % and 95 % percentiles are also shown for the fat mass indices in the form of tolerance ellipses.

Medical basis • 49

Page 50

6.3 Evaluation modules

Development/growth This module indicates both the weight and the height of a person and

The evaluation modules described below are pre-set in this device and assist you in assessing your patients' state of health.

The evaluation modules offer the option of only viewing those evaluation parameters (see “Evaluation parameters” on page 47) relevant to a specific objective.

For information about how to access the evaluation modules and navigate within them, see “Viewing analyses” from page 42.

automatically calculates BMI. In this way, weight changes in both children and adults can be monitored.

In children, this module assists with regular checks to assess growth and development.

No bioimpedance analysis is required for this module. The following parameters are displayed:

•weight

•height

• body mass index (BMI)

50 •

The following detail views are available for this module:

Page 51

English

Weight percentile curves for children

Height percentile curves for children

Medical basis • 51

Page 52

BMI percentile curves for children

WHO reference values for adults

52 •

Page 53

English

Energy The aim of this module is to determine a person's energy expenditure and

energy reserves. The following parameters are displayed:

• fat mass (FM)

• fat mass index (FMI)

• energy stored in the body (E

• resting energy expenditure (REE)

• total energy expenditure (TEE)

No bioimpedance measurement is required for the resting energy expenditure (REE) parameter. Resting energy expenditure is determined with the aid of the parameters height and weight and with the automatic BMI calculation.

For all other parameters in this module, a bioimpedance measurement is required in addition to height and weight.

body

)

The following detail view is available in this module:

Normal range display of fat mass for adults

Medical basis • 53

Page 54

Function/rehabilitation This module is for determining a person's level of fitness. This allows the suc-

cess of a training regime to be assessed. For this module, the parameters height and weight are required, as well as a bioimpedance measurement. The following parameters are displayed:

• fat-free mass (FFM)

• fat mass (FM)

• fat mass index (FMI)

• fat-free mass index (FFMI)

• skeletal muscle mass (SMM)

The following detail views are available for this module:

Normal range display of fat mass for adults

54 •

Page 55

English

Body Compostion Chart (mass indices)

Skeletal muscle mass

Medical basis • 55

Page 56

Fluid This module allows a person's fluids status to be determined. For this mod-

ule, the parameters height and weight are required, as well as a bioimpedance measurement. The following parameters are displayed:

• total body water (TBW)

• extracellular water (ECW)

• hydration (HYD); HYD =(100 x ECW) / (TBW-ECW) [%]

• bioimpedance vector analysis (BIVA)

The following detail view is available for this module:

Bioimpedance vector analysis

56 •

Page 57

English

Health risk The aim of this module is to provide an overview of body composition and to

compare the results with values for healthy people. A body composition which deviates from the normal range is an indicator which can be used to assess the risk to health. For this module, the parameters height and weight are required, as well as a bioimpedance measurement. The following parameters are displayed:

• phase angle (φ)

• visceral adipose tissue (VAT)

• bioimpedance vector analysis (BIVA)

• fat mass index (FMI)

• fat-free mass index (FFMI)

The following detail views are available for this module:

Normal range display for phase angle

Medical basis • 57

Page 58

Bioimpedance vector analysis

Body Compostion Chart (mass indices)

58 •

Page 59

English

Raw data for impedance This module shows detailed raw data for resistance (R), reactance (Xc),

impedance (Z) and phase angle (φ) for information purposes.

You can also view impedance (Z), reactance (X angle (ö) for the frequencies 50 Hz and 5 Hz.

NOTE:

seca 115 PC software, you can view the raw data for impedance

In the for individual body parts and for additional frequencies. For further information, see the “Instructions for use for doctors and assistants” of the PC software.

), resistance (R) and phase

Medical basis • 59

Page 60

6.4 References

Reference used

The scientific basis for bioimpedance analyses using the Medical Body Composition Analyzer seca 515/514 is clinical studies. The results of the clinical studies are stored as references in the device software and form the basis for assessing the state of health of your patients.

The references used by the device depend on the country in which you are operating. As part of the device configuration, your administrator will enter your country as the setup location. The usual references for your country will be loaded automatically.

For some evaluation parameters (e.g. waist circumference for children), the reference used also depends on the patient's ethnicity. The device automatically uses ethnicity-dependent references to suit the corresponding entry in the seca patient file (see “Creating a new seca patient file” on page 40).

The evaluation module in question indicates which clinical study is being used as a reference for determining and assessing an evaluation parameter, e. g. “Peine et al. 2013”.

60 •

Details about the referenced clinical trials can be found on our website www.seca.com.

Page 61

English

7. CONFIGURING THE DEVICE

7.1 Adapting default module selection for bioimpedance analysis

The default module selection determines which evaluation modules are considered during a bioimpedance analysis.

The device is factory set, so that when the

module selection

vated. This way, the module selection can be verified before each measurement and, if necessary, adapted to suit the individual measurement.

The device can be configured in such a way that the dialog window does not appear if the bia tab is activated. You can also create an in-house default module selection.

dialog window appears and all evaluation modules are acti-

bia tab is activated, the Default

Default module selection

Showing/hiding default module

selection

In order to determine whether or not the Default module selection dialog window is displayed before each bioimpedance analysis, proceed as outlined below.

1. Press the

The secondary menu is displayed.

2. Press the

The

The current setting is displayed (button appears gray = pressed).

3. Press the desired setting.

4. Press the apply button.

The module selection is saved and available from the next bioimpedance analysis.

switch menu button.

settings button.

User menu appears.

–

No: default module selection is active. It is displayed before every

bioimpedance analysis and can be adapted to suit the measurement in question.

– Yes: default module selection is active but is not displayed before

the bioimpedance analysis. Adaptations to the default module selection are possible only in the

settings menu.

Configuring the device • 61

Page 62

Creating default module selection In order to create an in-house default module selection, proceed as outlined

below.

1. Press the

The secondary menu is displayed.

2. Press the

The

3. Press the drop-down menu.

The drop-down menu opens.

4. Press the

switch menu button.

settings button.

User menu appears.

Default module selection menu element.

The current module selection is displayed. The Raw data for impedance evaluation module is deactivated at the fac-

tory. Activation/deactivation of the Raw data for impedance, Energy and

Health risk evaluation modules affects bioimpedance analysis as outlined

in the table below.

Evaluation

module

Setting

• = activated,

- = deactivated

Effect

• Physical activity level (PAL) is interrogated

Energy

No interrogation of physical activity level (PAL)

• Waist circumference (WC) is interrogated

Health risk

No interrogation of waist circumference (WC)

- Measurement duration: 20 seconds

Raw data for impedance

•

Measurement duration: 90 seconds Raw data for impedance available for 19 frequencies

a.Interrogation of PAL and WC in the Module-specific entries dialog window.

Dialog window is skipped if the Energy are deactivated.

and Health risk evaluation modules

5. Press all modules you wish to deactivate.

The tick in the checkbox is no longer displayed.

62 •

NOTE:

Press on a module again to reactivate it.

Page 63

English

7.2 Saving settings

Applying settings 1. Press the apply button.

Exiting Settings\user menu 1. Press the Finish button.

6. Press the apply button.

The module selection is saved and available from the next bioimpedance analysis.

NOTE:

To exit the dialog window without saving, press the the most recently active tab (red, in this case:

cancel button or

bia). The most recently

active tab is active again.

The

Save operation successful dialog window appears.

2. Press the

The You can implement additional settings in the

continue button.

settings\User menu appears in the display again.

settings\User menu or exit

the menu as described in the section entitled “Exiting Settings\user menu” on page 63.

The

Unsaved changes dialog window appears.

2. Press the desired button:

–

Yes: the changes are saved. The most recently active tab is active

again. The device is ready for measurement.

–

No: the changes are not saved. The most recently active tab is

active again. The device is ready for measurement.

Configuring the device • 63

Page 64

8. HYGIENE TREATMENT

8.1 Cleaning

WARNING! Electric shock

The device is not de-energized when the on/off button is pressed and the display goes out. Use of fluids on the device may cause electric shock.

► Before each hygiene treatment, ensure that the device is switched

off.

► Disconnect the power supply before each hygiene treatment.

► Ensure that no fluids penetrate the device.

CAUTION! Damage to device

Unsuitable cleaning agents and disinfectants may damage the sensitive surfaces of the device.

► Use only chlorine and alcohol-free disinfectants 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).

► Clean the surfaces of the device with a soft cloth as required, dipped in a

mild soap solution if necessary.

8.2 Disinfecting

8.3 Sterilizing

1. Check that your disinfectant is suitable for sensitive surfaces and acrylic

sheet.

2. Follow the instructions on the disinfectant.

3. Disinfect the device:

– Moisten a soft cloth with disinfectant and wipe down the device – Comply with the intervals: see table

Interval Component

Before each

measurement

After every measurement

As required

The device may not be sterilized.

• weighing platform and foot electrodes

• standing aid and pair of hand electrodes

• weighing platform and foot electrodes

• standing aid and pair of hand electrodes

• touchscreen display

• Controls

64 •

Page 65

English

9. FUNCTION CHECK

► Perform a function check prior to each use.

A complete function check includes:

• visual inspection for mechanical damage

• checking the alignment of the device

• visual and function check of the display elements

• function check of all the controls shown in the section entitled “Overview”

• function check of optional accessories

If you notice any faults or deviations during the function check, first try to resolve the error with the aid of the section entitled “What do I do if ...” in this document.

CAUTION!

Personal injury

If you notice any faults or deviations during the function check which cannot be resolved with the aid of the section entitled “What do I do if ...” in this document, you may not use the device.

► Have the device repaired by seca service or by an authorized service

partner.

► Follow the section entitled “Servicing” in this document.

► Follow the section entitled “Servicing/recalibration” in this

document.

10.MAINTENANCE/SUBSEQUENT VERIFICATION (VERIFIED MODEL)

10.1 Information on maintenance and subsequent verification

We recommend having your device serviced prior to subsequent verification.

The device’s measurement technology for bioimpedance analysis (BIA) must be checked every two years.

NOTICE! Incorrect measurements as a result of poor servicing

► Please only have servicing and repairs performed by an authorized

service partner.

► You can find a service partner in your area at www.seca.com or by

sending an e-mail to service@seca.com.

Have an authorized technician perform subsequent verification according to national legal regulations.

Subsequent verification is necessary whenever one or more verification seals are damaged or the contents of the verification counter no longer match the number on the applicable verification counter sticker.

10.2 Checking the contents of the verification counter

The scale has been verified. Verifications may only be performed by authorized agencies. To guarantee this, the scale is equipped with a verification counter which records each change in verification-related data.

If you want to check whether the scale has been properly verified, follow the instructions below.

1. Switch on the device.

2. Press the

switch menu button.

Function check • 65

Page 66

3. Press the settings button.

The

User dialog window appears.

The verification counter reading (in this case: 1) is displayed.

4. Compare the content of the verification counter output with the number

given on the verification counter sticker.

Both numbers have to match for the verification to be valid. If the sticker and the verification counter do not match, the scale must be subsequently verified. Please contact your service partner or seca service.

Once the scale has been subsequently verified, a new, updated verification counter sticker is used to identify the verification counter reader. The person authorized to perform the subsequent verification secures this sticker with an additional seal. The verification counter sticker can be ordered from seca service.

11.MAINTENANCE (UNVERIFIED MODEL)

On leaving the factory, your seca device has an accuracy of ±0.15% or better. To preserve this level of accuracy, the product must be set up with care and maintained on a regular basis.

The device’s measurement technology for bioimpedance analysis (BIA) must be checked every two years. We recommend performing maintenance of the whole device as part of this check.

NOTICE! Incorrect measurements as a result of poor servicing

► Please only have servicing and repairs performed by an authorized

service partner.

► You can find service partners in your area at www.seca.com or by

sending an e-mail to service@seca.com.

66 •

Page 67

English

12.TROUBLESHOOTING

12.1 Power supply and display

Problem Cause Remedy

Device cannot be switched on

Touchscreen display stays dark

Touchscreen display not reacting

Image on touchscreen display faulty

12.2 Height and weight

Problem Cause Remedy

0.00 does not appear before weighing

The STOP message appears Maximum load exceeded Remove the load from the device

TEMP message appears

The message ER11 appears

The message ER12 appears

The message ER16 appears

No power supply Check whether power is being supplied

Power pack faulty Replace power pack with original part

• Touch the touchscreen display

Device on standby

• Press the on/off button

• Place a load on the device

Device not switched on Switch on device

No power supply Check whether power is being supplied

Touchscreen display faulty Inform seca service

Device in undefined state following implausible input

• Switch off the device (hold the on/off button for approx. 3 seconds)

• Switch on the device again

Touchscreen display faulty Inform seca service

Device had load on it before it was switched on

• Remove the load from the device

• Switch off the device, then switch back on again

• Set up the device in an ambient tempera-

Ambient temperature too high or too low

ture between +10 °C and +40 °C

• Wait for around 15 minutes until the device has adapted to ambient temperature

Device overloaded as a whole or in one corner

Device switched on with too heavy a load

Natural vibration has been induced in device, zero point could not be determined

• Remove the load or distribute the load evenly

• Restart the device

• Remove the load from the device

• Restart the device

• Restart measurement

Troubleshooting • 67

Page 68

12.3 Bioimpedance analysis

Problem Cause Remedy

bia tab activated, but module selection does not appear

Not all modules activated in module selection

The following message appears: “Electrode detection failed.”

No PAL value can be entered after bioimpedance measurement

No waist circumference can be entered following bioimpedance measurement

Results of bioimpedance measurement deviate significantly from expected results

Value of an evaluation parameter is shown in red

After a different tab has been called up temporarily, the assigned seca patient file is no longer shown in the patient tab

Module selection deactivated

Default module selection specified in which some modules are deactivated

Patient’s skin too dry

Patient’s skin too calloused

Electrodes faulty Inform seca service

Energy

Health risk

deactivated

Patient moved during the measurement

Patient used different pairs of hand electrodes on the left and right

Electrodes faulty Inform seca service

Value outside the normal range determined for the evaluation parameter

seca patient file selected, but selection not confirmed

evaluation module deactivated

evaluation module

Check setting and change if necessary (see “Adapting default module selection for bioimpedance analysis” on page 61)

• Activate missing modules directly in the module selection and perform the measurement

• Adapt default module selection (see “Creating default module selection” on page 62)

Spray the skin with electrode spray at the contact points

Energy evaluation module is not

• If the required, continue and complete measurement

Energy evaluation module is

• If the required, activate the evaluation module (see “Checking module selection” on page 31 or “Creating default module selection” on page 62)

• If the

Health risk evaluation module is not

required, continue and complete measurement

Health risk evaluation module is

• If the required, activate the evaluation module (see “Checking module selection” on page 31 or “Creating default module selection” on page 62)

Request that the patient does not move during the measurement and repeat the measurement

Ensure that the patient uses the same hand electrodes on both sides and repeat the measurement

• Repeat the measurement in order to exclude measurement errors

• If the repeat measurement also produces a value outside the normal range, take the value into account in further investigations

Re-assign seca patient file and press the

confirm button (see “Assigning a

measurement to a patient file” on page 36), only then call up another tab

68 •

Page 69

English

12.4 Data transmission

Problem Cause Remedy

Data transmission between device and seca 115 cannot be set up

A seca patient file is shown as “not assigned” in the seca 115 PC software following import from a USB memory stick

seca patient file cannot be found when searching for a patient on the device

Patient name cannot be entered in the set dialog language

seca patient file cannot be provided from the PC software

No access to seca patient database of the seca 115 PC software

USB memory stick connected to touchscreen display but no access to the seca patient database

Administrator: use compatible software

Software versions incompatible

version:

• device: min. software version 1.1

• PC software: min. software version 1.4

• Manually assign current seca patient file to

USB PIN of the USB memory stick used for access to the seca patient database of the USB memory stick

an attending physician in seca 115

• To import other patient files, use user PIN to access the seca patient database of the USB memory stick

No seca patient file set up yet

seca patient file is not yet assigned to you in the

seca 115

Port blocking of Windows firewall active, ports used for communicating with device being blocked

Create a seca patient file (see “Creating a new seca patient file” on page 40)

Check whether or not the seca patient file can be assigned to you in the seca 115.

Administrator: release the ports used for communication with the device in Windows firewall

• Provide the seca patient file from the PC

No keypad available for set dialog language

software (see “Providing a seca patient file from the PC software” on page 39)

• Administrator: check whether the settings for region and language are correct.

Function not available via seca 360° wireless network, no network connection established via Ethernet

Administrator: establish Ethernet connection

No seca 360° wireless network established between the device and the PC on which the

seca 115 PC

Administrator: set up the seca 360° wireless network

software is installed

No Ethernet connection established between the device and the PC on which the seca 115 PC software is

Administrator: establish Ethernet connection

installed

Device connected to a standalone PC via Ethernet cable, PC network card does not allow automatic crossover

No USB memory stick connected to the touchscreen display

The PC on which the seca 115 PC software is installed has not been switched on.

seca 115 PC software not started Start the seca 115 PC software

Non-initialized USB memory stick being used

PIN not entered or entered incorrectly

Unsuitable USB memory stick being used

Problem due to HF emissions from other devices (e.g. cellphones)

Administrator: use a crossover adapter (see “Technical data” on page 71)

Connect USB memory stick to the touchscreen display

Switch on the PC and start the PC software

• Use the USB memory stick supplied

• Administrator: initialize USB memory stick using the

seca 115 PC software

Use your user PIN or the USB PIN for the USB memory stick

• Use the USB memory stick supplied

• Use a FAT16 USB memory stick

Increase distance from HF devices

seca 115

Troubleshooting • 69

Page 70

12.5 Printing

Problem Cause Remedy

Print function not available

Results report not being printed

No personal data in results report

No bioimpedance parameters in results report

No height in results report

Administrator: use compatible software

Software versions incompatible

version:

• device: min. software version 1.1

• PC software: min. software version 1.4

PC printer not switched on Switch on PC printer

The PC on which the software is installed has not been

seca 115 PC

Switch on PC

switched on.

No network connection established between device and seca 115 PC software

No connection established between

seca 115 PC software and PC printer

On repeat measurement: no seca patient file assigned

On initial measurement: seca patient file not created yet

No bioimpedance measurement performed

Administrator: establish Ethernet connection

Administrator: establish connection between

seca 115 PC software and PC

printer

patient tab and assign seca patient

Call up file (see “Searching for a seca patient file” on page 37)

patient tab and create seca patient

Call up file (see “Creating a new seca patient file” on page 40)

Call up the

bia tab and perform the

measurement (see “Performing a bioimpedance measurement” on page 31)

Call up the weight/height tab and enter

No height entered on device

height (see “Entering height manually” on page 29)

Measure the height of the patient again,

No height transmitted by the length measuring device

seca 360°

then press the length measuring device (see “Transmitting height via seca 360° wireless network” on

send/print button on the

page 29)

70 •

Page 71

English

13.TECHNICAL DATA

13.1 General technical data

General technical data

Measurements

•Depth

•Width

•Height

Net weight approx. 36 kg

Ambient conditions, operation

• Temperature

• Air pressure

•Humidity

Ambient conditions, storage

• Temperature

• Air pressure

•Humidity

Ambient conditions, transport

• Temperature

• Air pressure

•Humidity

Setup location, maximum altitude above mean sea level 3000 m

Display type

Power supply Power pack

Mains voltage 100 V - 240 V

Mains frequency 50 Hz - 60 Hz

Power consumption

• Standby (touchscreen display off, on/off button green)

• In operation (no bioimpedance measurement, on/off button white)

• In operation (bioimpedance measurement in progress, on/off button white)

Medical device in accordance with Directive 93/42/EEC Class IIa

EN 60601-1:

• Insulated device, protection class II

+10 °C to +40 °C (50 °F to 104 °F)

700 hPa - 1060 hPa

30 % - 80 %, no condensation

-10 °C to +65 °C (14 °F to 149 °F) 700 hPa - 1060 hPa

0 % - 95 %, no condensation

-10 °C to +65 °C (14 °F to 149 °F) 700 hPa - 1060 hPa

0 % - 95 %, no condensation

8.4" touchscreen display, can be

swiveled 180° to the left and right

828 mm 976 mm

1251 mm

< 2.7 W < 6.6 W

< 15 W

• Medical electrical device, type BF

seca 360° wireless network:

• frequency band

• transmission power

Interfaces:

• touchscreen display

• weighing platform

USB memory stick requirements:

• Minimum disk space requirements

• File system

Compatible printer

2.433 GHz - 2.480 GHz < 10 mW

USB 2.0

Ethernet (10/100 Base-T)

FAT 16

Microsoft

printer via seca 115 PC software

Windows®-compatible

Technical data • 71

2 GB

Page 72

13.2 Technical data, bioimpedance analysis

Technical data, bioimpedance analysis

Measuring method 8-point bioimpedance analysis

Electrode type

Measuring frequencies

Measured values

Impedance measuring range 10 Ω to 1000 Ω

Measuring segments

Measuring current 100 μ (+20 %, -50 %)

Measurement duration: frequencies 5 kHz and 50 kHz all frequencies (only if

Raw data for impedance module active)

Accuracy at frequencies 5 kHz and 50 kHz Segments: right side of body, left side of body

• Impedance (at phase angle 0°)

• Phase angle (at phase angle 0°, impedance 200 Ω to 1000 Ω)

Evaluation parameters

Stainless steel, 2 x 3 pairs of hand electrodes, 2 pairs of foot electrodes

1; 1.5; 2; 3; 5; 7.5; 10; 15; 20; 30; 50; 75; 100; 150; 200; 300; 500; 750; 1000 kHz

Impedance (Z), resistance (R), reactance (X

), phase angle (φ)

Right arm, left arm, right leg, left leg, right side of body, left side of body, torso

See “Evaluation parameters” from page 47

max. 20 s max. 90 s

±5 Ω

0.5°

Ethnicity:

other

SEE

Measure of certainty (R2) and standard deviation (SEE) for predictive formulas in this device

Ethnicity:

South/Central

American

SEE

Parameter

Ethnicity:

Caucasian

SEE

Ethnicity:

African-American

SEE

Ethnicity:

Asian

SEE

FFM 0.96 2.17 kg 0.95 2.41 kg 0.95 1.92 kg 0.95 1.85 kg 0.96 2.07 kg

TBW 0.95 1.8 l 0.97 1.4 l 0.96 1.3 l 0.95 1.3 l 0.96 1.4 l

ECW 0.84 1.1 l 0.90 0.8 l 0.91 0.7 l 0.90 0.7 l 0.90 0.8 l

SMM

left arm

SMM

right arm

SMM

left leg

SMM

right leg

SMM

total

0.88 0.18 kg 0.81 0.27 kg 0.82 0.19 kg 0.89 0.14 kg 0.86 0.2 kg

0.85 0.21 kg 0.80 0.26 kg 0.83 0.18 kg 0.90 0.13 g 0.86 0.20 kg

0.55 0.78 kg 0.73 0.70 kg 0.37 0.75 kg 0.25 0.74 kg 0.64 0.74 kg

0.70 0.66 kg 0.80 0.6 kg 0.60 0.63 kg 0.50 0.63 kg 0.75 0.63 kg

0.89 2.0 kg 0.90 2.2 kg 0.85 2.0 kg 0.88 1.8 kg 0.90 2.0 kg

VAT 0.89 0.5 l 0.61 0.7 l 0.71 0.6 l 0.54 1.2 l 0.75 0.8 l

a. In the USA, a study was conducted with 130 healthy adults of different ethnicities. The aim of the study was to validate the

parameters determined using seca formulas against clinically established reference methods. The results of this comparative study are shown in the table above. The table shows the degree of certainty (R eters determined using seca's formulas by ethnicity.

) and standard deviation (SEE) for the param-

72 •

Page 73

English

13.3 Weighing data (verified model)

seca 515

Accuracy class in accordance with Directive 2014/31/EU III

Measuring method 4 load cells

Maximum load

• Partial weighing range 1

• Partial weighing range 2

Minimum load

• Partial weighing range 1

• Partial weighing range 2

Increments

• Partial weighing range 1

• Partial weighing range 2

Tare range to 300 kg

Accuracy on initial verification

• Weighing range 1: 0 to 25 kg

• Weighing range 1: 25 kg to 100 kg

• Weighing range 1: 100 kg to 150 kg

• Weighing range 2: 0 to 50 kg

• Weighing range 2: 50 kg to 200 kg

• Weighing range 2: 200 kg to 300 kg

13.4 Weighing data (unverified model)

150 kg 300 kg

1 kg 2 kg

50 g

100 g

±25 g ±50 g ±75 g

±50 g ±100 g ±150 g

seca514

Measuring method 4 load cells

Maximum load

• Partial weighing range 1

• Partial weighing range 2

Minimum load

• Partial weighing range 1

• Partial weighing range 2

Increments

• Partial weighing range 1

• Partial weighing range 2

Tare range 300 kg

Accuracy

•0 to 35 kg

• 35 kg to maximum load

•0 to 75 lbs

• 75 lbs to maximum load

• 0 to 5.5 sts

• 5.5 sts to maximum load

150 kg / 330 lbs / 24 sts 300 kg / 660 lbs / 47 sts

1.0 kg

2.0 kg

50 g / 0.1 lbs

100 g / 0.2 lbs

±100 g

±0.3%

±0.2 lbs

±0.3%

±0.2 lbs

±0.3%

Technical data • 73

Page 74

13.5 Technical modifications

Combination seca 515/514 (SW version 1.1) seca 115 (SW version 1.4)

Downward-compatible: no

• regional settings: drop-down menus

• enter waist circumference with

• visceral adipose fat (VAT) parameter in the

New:

Modified:

No longer applicable: lean soft tissue (LST) parameter in

• skeletal muscle mass (SMM) parameter in the Function/rehabilitation evaluation module

• send individual seca patient file from the

• start printing out results reports directly on device (

graphical representation: phase angle (φ), bioimpedance vector analysis (BIVA), body composition chart (BCC), total body water (TBW)

Name format, Name hyphen

Health risk evaluation module activated

Health risk evaluation module

seca 115 PC software to mBCA

seca 515/514)

Function/rehabilitation evaluation module

14.OPTIONAL ACCESSORIES

Accessory Article number

Measuring stations

•

seca 285

• seca 284

Length measuring rods

•

seca 274

• seca 264

PC software

seca analytics 115 Application-specific license packages

•

seca 360° wireless USB adapter 456 USB wireless adapter 456-00-00-009

Country-specific versions Country-specific versions

15.SPARE PARTS

Spare parts Article number

Power pack, Euro: 100-240 V~ / 50-60 Hz / 12 V= / 1.2 A 68-32-10-268

seca 201 circumference measuring tape 201-17-17-009

DVD with workplace

seca 360° wireless USB adapter 456 456-00-00-009

Ethernet cable (1.5 m) 08-06-16-467

seca analytics 115 PC software and license for a permanent

Country-specific versions

16.DISPOSAL

Do not dispose of the device with your household waste. It has to be properly disposed of as electronic waste. Follow your respective national regulations. For more information, please contact our service representatives at:

service@seca.com

74 •

Page 75

English

17.WARRANTY

There is a two-year warranty period from delivery for defects attributable to material or fabrication errors. All movable parts, including batteries, cables, power packs, rechargeable batteries etc. are exempt. Defects which come under the warranty will be repaired for the customer free of charge against proof of purchase. Additional claims cannot be considered. Costs of transport to and from seca are the responsibility of the customer if the device is located somewhere other than the customer's headquarters. In the event of transport damage, warranty claims can only be made if the complete original packaging was used for transport and the device was secured and fastened therein according to its originally-packed condition. You should therefore keep all packaging parts.

The warranty will be voided if the device is opened by persons not expressly authorized by seca to do so.

We ask customers overseas to contact the seller in their respective country directly in the event of warranty claims.

18.DECLARATION OF CONFORMITY

seca gmbh & co. kg hereby declares that the product meets the terms of the applicable European directives. The unabridged declaration of conformity can be found at: www.seca.com.

Warranty • 75

Page 76

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17-10-07-626-002a/04-2016 G

Seca 515, 514 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. DEVICE DESCRIPTION

1.1 Intended use

1.2 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

Analysis Bioimpedance measurements are analyzed in graphical form based on scien-

Management of user data Access data for users of the device are managed in the seca 115 PC software

Compatibility This device (software version 1.1) is compatible only with version 1.4 of the

1.3 User qualification

Administration/network connection The device may only be set up and connected to a network by experienced

Measuring mode The device and the seca 115 PC software may only be operated by persons

1.4 Contraindications

2. SAFETY INFORMATION

2.1 Safety rules in the instructions for use

2.2 Basic safety information

Handling the device ► Please take note of the information in these instructions for use.

Preventing electric shock WARNING!

Preventing injuries and infections WARNING!

Preventing device damage NOTICE!

Dealing with measuring results WARNING!

Dealing with packaging WARNING!

3. OVERVIEW

3.1 Controls

3.2 Symbols in the start display

3.3 Color symbols and other controls

3.4 Identification on the device and the type plate

3.5 Identification on the packaging

4. BEFORE YOU REALLY GET STARTED ...

4.1 Scope of delivery

4.2 Establishing power supply

4.3 Setting up the device

4.4 Configuring the device

4.5 Operating the device in a PC network

Printing If the device is connected to the seca 115 PC software via Ethernet, you can

4.6 Operation using a seca 360° length measuring device

5. OPERATION

5.1 Operating concept

Swiveling the touchscreen display The touchscreen display of the device can be swiveled. As a result, it can be

Switching on the device The device is switched on using the ON/OFF button. During the switch-on

Selecting functions Functions can be selected using the following elements of the touchscreen

Selecting extended functions Functions commonly used in a certain context are accessible in the primary

Entering text Text is entered via a computer keyboard shown on the touchscreen display.

Display special characters Special characters can also be displayed with the computer keyboard.

Entering numbers Numbers are entered via a computer numerical keypad shown in the

Measuring procedure The operating concept is based on the typical measuring procedure outlined

Automatic standby The device automatically switches to standby if there are no entries on the

Switching off the device WARNING!

5.2 Determining weight and height

Starting the weighing procedure 1. Ensure that the device has no load.

Taring off additional weight (tare) Using the tare function, you can prevent additional weight (e.g. a towel or a

Entering height manually To enter height manually, to determine BMI for example, proceed as outlined

Calculating BMI automatically To determine BMI, you have to record the patient's height as well as their

Printing partial results You can print out the measured results so far. Proceed as described in the

5.3 Performing a bioimpedance measurement

Switching on the device 1. Ensure that the device has no load.

Determining weight and height ► Determine weight and height as described in the section entitled

Checking module selection

Starting measurement 1. State whether the patient belongs to a group of people for whom a

Printing partial results You can print out the measured results so far. Proceed as described in the

5.4 Assigning a measurement to a patient file

Checking data connection ► Ensure that you can access a seca patient database in one of the

Searching for a seca patient file To search for seca patient files, proceed as outlined below.

Creating a new seca patient file 1. Press the patient tab.

Editing patient data You cannot make changes to patient data directly on the device. If you dis-

5.5 Viewing analyses

5.6 Closing the measuring procedure

Saving the measured results 1. Ensure that you can access a seca patient database in one of the

Printing results report If the device is connected to a PC printer via seca 115, you can start printing

6. MEDICAL BASIS

6.1 Bioimpedance analysis (BIA)

Classic body composition analysis The current “gold standard” for body composition analysis comprises a com-

6.2 Evaluation parameters

Summary of evaluation parameters With seca, the parameters required for assessing body composition are

6.3 Evaluation modules

Development/growth This module indicates both the weight and the height of a person and