Seca mBCA 514 User Manual

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seca 515/514

Administrator Manual

Software version 1.1 from

Build 550

English

CONTENTS

1. Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.2 Description of function. . . . . . . . . . . . . . . . . . . . . . 3

Calculating weight and height . . . . . . . . . . . . . . 3

Bioimpedance measurement. . . . . . . . . . . . . . . 3

Administering patient data. . . . . . . . . . . . . . . . . 3

Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Administration of user data . . . . . . . . . . . . . . . . 4

Data transmission and network functions . . . . . 4

Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3 User qualification . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Administration/network connection . . . . . . . . . . 4

Measuring mode . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . 5

2. Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.1 Safety instructions in these instructions for use . . . 6

2.2 Basic safety instructions . . . . . . . . . . . . . . . . . . . . 6

Handling the device. . . . . . . . . . . . . . . . . . . . . . 6

Preventing electric shock. . . . . . . . . . . . . . . . . . 7

Preventing injuries and infections. . . . . . . . . . . . 7

Preventing device damage . . . . . . . . . . . . . . . . 8

Dealing with measuring results . . . . . . . . . . . . . 8

Dealing with packaging . . . . . . . . . . . . . . . . . . . 9

3. Device overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.1 Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.2 Symbols in the start display . . . . . . . . . . . . . . . . . 12

3.3 Color symbols and other controls . . . . . . . . . . . . 14

3.4 Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.5 Identification on the device and the type plate . . . 17

3.6 Identification on the packaging . . . . . . . . . . . . . . 18

4. Making the device operational . . . . . . . . . . . . . . . . . 19

4.1 Scope of delivery. . . . . . . . . . . . . . . . . . . . . . . . . 19

4.2 Establishing power supply . . . . . . . . . . . . . . . . . . 20

4.3 Setting up the device. . . . . . . . . . . . . . . . . . . . . . 20

4.4 Operating the device in a PC network . . . . . . . . . 21

Connecting the network via Ethernet or

seca 360° wireless network . . . . . . . . . . . . . . . 21

Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Indirect connection via USB memory stick. . . . 22

4.5 Operation using a seca 360° stadiometer . . . . . . 23

5. Operating concept . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.1 Swiveling the touchscreen display . . . . . . . . . . . . 24

5.2 Switch on device . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.3 Selecting functions . . . . . . . . . . . . . . . . . . . . . . . 24

5.4 Selecting extended functions. . . . . . . . . . . . . . . . 25

5.5 Entering text . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5.6 Entering numbers . . . . . . . . . . . . . . . . . . . . . . . . 26

5.7 Measuring procedure . . . . . . . . . . . . . . . . . . . . . 26

5.8 Automatic standby . . . . . . . . . . . . . . . . . . . . . . . 27

5.9 Switching off the device. . . . . . . . . . . . . . . . . . . . 27

6. Configuring the device. . . . . . . . . . . . . . . . . . . . . . . . 28

6.1 Adapting the default module selection for

bioimpedance analysis . . . . . . . . . . . . . . . . . . . . 28

Showing/hiding default module selection. . . . . 28

Creating default module selection . . . . . . . . . . 29

6.2 Administering user accounts and access rights . . 30

6.3 Calling up the Administrator menu. . . . . . . . . . . . 30

6.4 Making default settings . . . . . . . . . . . . . . . . . . . . 32

Setting units of measurement . . . . . . . . . . . . . 32

Making regional settings . . . . . . . . . . . . . . . . . 32

Setting the date and time . . . . . . . . . . . . . . . . 35

Setting display brightness and volume. . . . . . . 36

6.5 Setting up the network . . . . . . . . . . . . . . . . . . . . 36

Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 36

Network services. . . . . . . . . . . . . . . . . . . . . . . 36

Network-dependent functions . . . . . . . . . . . . . 37

Integrate device in an Ethernet network. . . . . . 37

Setting up seca CLS network

(via Ethernet only). . . . . . . . . . . . . . . . . . . . . . . 38

Setting up the seca 360° wireless network . . . 40

Viewing wireless devices . . . . . . . . . . . . . . . . . 42

6.6 System data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Viewing versions . . . . . . . . . . . . . . . . . . . . . . . 43

Making system settings. . . . . . . . . . . . . . . . . . 43

Using service functions . . . . . . . . . . . . . . . . . . 48

6.7 Saving settings . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Applying settings. . . . . . . . . . . . . . . . . . . . . . . 50

Exiting the administrator menu . . . . . . . . . . . . 50

7. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

7.1 Power supply and display . . . . . . . . . . . . . . . . . . 51

7.2 Height and weight . . . . . . . . . . . . . . . . . . . . . . . . 51

7.3 Bioimpedance analysis . . . . . . . . . . . . . . . . . . . . 52

7.4 Data transmission . . . . . . . . . . . . . . . . . . . . . . . . 53

7.5 Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

8. Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . 55

9. Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

10. Technical information . . . . . . . . . . . . . . . . . . . . . . . 56

10.1 The seca 360° wireless network . . . . . . . . . . . . 56

10.2 Technical modifications . . . . . . . . . . . . . . . . . . . 56

10.3 Additional technical information . . . . . . . . . . . . . 57

11. Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

12. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

13. Declaration of conformity . . . . . . . . . . . . . . . . . . . . 57

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English

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 parameters, e.g. fat-free mass (FFM), which can be derived from them for automatic calculation. The results are displayed graphically and assist the attending physician with the following medical issues:

• determining energy expenditure and energy reserves as a basis for nutritional advice

• assessing metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy

• determining a patient's fluids status

• determining general state of health or, in the case of a previously-known disease, assessing its severity

seca 515/514 is not a diagnostic device. To make an accurate diagnosis,

The the physician needs to commission thorough examinations and take their results into account in addition to the results of the

seca 515/514 device records weight, height and bio-

seca 515/514.

Calculating weight and 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° stadiometer.

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 3 pairs of hand electrodes. The hand electrodes are attached at different heights so that persons with a height of between 1.60 m and 2.0 m can adopt the ideal position on the device for a bioimpedance measurement.

Administering patient data seca patient files can be created directly on the device for administering mea-

sured results. The seca patient files are stored in the patient database of the

seca analytics 115 PC software supplied. Alternatively, seca patient files can

be saved on the USB memory stick supplied. The USB memory stick likewise contains a seca patient database.

seca patient files and seca patient databases contain exclusively data necessary for working with seca products or determined using seca products. seca patient files can be administered and edited only using the software. The export and import functions of the be used for exchanging data with surgery and hospital information systems.

seca 115 PC software can

seca 115 PC

Evaluation Bioimpedance measurements are evaluated in graphical form based on sci-

entifically-established formulas. An in-house study by seca established formulas for determining the parameters of total body water (TBW), extracellular water (ECW), fat-free mass (FFM) and skeletal muscle mass (SMM) for arms, legs, torso and the whole body. In the same studies, in-house reference values were determined for the following parameters, in order to allow normal ranges to be shown: bioelectric impedance vector analysis (BIVA), mass indices (FMI, FFMI), phase angle (φ). You can find further information in the Instructions for Use for Physicians and Assistants.

Device description • 3

Administration of user data Access data for users of the device is administered in the seca 115 PC

software supplied. A user PIN for the seca 515/514 is generated automatically when user accounts for the seca 115 are created. The administrator also has the option of specifying a user PIN him or herself.

The device can only be configured with administrator rights. An initial administrator PIN for the device is provided. It can only be changed on the device.

The creation and administration of user data is only necessary if the seca patient database of the device.

seca 115 PC software is to be accessed from the

Data transmission and network

functions

Compatibility This device (software version 1.1 from Build 550) is compatible only with ver-

The device is networkable. The network connection allows the device to use both the seca patient database and the special print function of the seca 115 PC software.

The special print function of the start printing out a detailed results report directly on the medical Body Composition Analyzer

Alternatively to the Ethernet link, seca mBCAs and the can communicate wirelessly via seca 360° technology. For this purpose, the

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

be connected to a PC on which at least the application software of the

seca 115 is installed.

seca 360° stadiometers can wirelessly transmit measured results to the

device.

The device has the following interfaces:

• on the weighing platform

– network connection (Ethernet)

• on the touchscreen display

– internal seca wireless module – USB interface for connecting a USB memory stick (included in the

scope of delivery)

sion 1.4 from Build 560 of the compatibility with older versions of the seca 115. For a summary of technical modifications, see the section entitled “Technical modifications” on page 56.

seca mBCAs with older device software can be updated. Go to www.seca.com and contact your local seca service partner.

seca 515/514.

seca 115 PC software makes it possible to

seca 115 PC software

seca 115 PC software. There is no downward

1.3 User qualification

Administration/network connection The device may only be set up and incorporated in a network by experienced

administrators or hospital technicians.

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

with sufficient specialist expertise.

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English

1.4 Contraindications

Bioimpedance measurements may not be performed on patients exhibiting the following characteristics:

• electronic implants, e.g. cardiac pacemakers

• active prostheses

Bioimpedance measurements may connected to one of the following devices:

• electronic life-support systems, e.g. artificial heart, artificial lung

• portable electronic medical devices, e.g. ECG devices or infusion pumps

Impedance measurements may only be performed on persons exhibiting the following characteristics after discussion with the attending physician:

• cardiac arrhythmias

• pregnancy

not be performed on persons who are

Device description • 5

2. SAFETY INFORMATION

2.1 Safety instructions in these instructions for use

DANGER!

Identifies an exceptionally hazardous situation. If you fail to take note of this information, serious irreversible or fatal injury will result.

WARNING!

Identifies an exceptionally hazardous situation. If you fail to take note of this information, serious irreversible or fatal injury may result.

CAUTION!

Identifies a hazardous situation. If you fail to take note of this information, minor to moderate injury may result.

ATTENTION!

Indicates that the product may have been operated incorrectly. If you fail to take note of this information, the device may be damaged or the measured results may be incorrect.

NOTE:

Contains additional information on how to use this device.

2.2 Basic safety instructions

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

► Keep the instructions for use in a safe place. The instructions for use are a

component of the device and must be available at all times.

DANGER!

Risk of explosion

Do not use the device in an environment in which one of the following gases has accumulated:

► oxygen

► flammable anesthetics

► other flammable substances/gas mixtures

CAUTION!

Hazard to patient, damage to device

Additional devices connected to medical electrical devices must

►

provide evidence of compliance with the relevant IEC or ISO standards (e.g. IEC 60950 for data-processing devices). Furthermore, all configurations must comply with the requirements of standards for medical systems (see IEC 60601-1-1 or Section 16 of the 3rd edition of IEC 60601-1 respectively). Anyone connecting additional devices to medical electrical devices is considered a system configurer and is therefore responsible for ensuring that the system complies with the requirements of standards for systems. Your attention is drawn to the fact that local laws take precedence over the abovementioned requirements of standards. In the event of any queries, please contact your local specialist dealer or Technical Service.

► Please have maintenance, subsequent verification (seca 515 only)

and BIA measuring technology checks performed every two years.

► Technical modifications may not be made to the device. The device

does not contain any parts for servicing by the user. Please only have maintenance, technical checks and repairs performed by an authorized service partner. You can find a service partner in your area at www.seca.com or by sending an e-mail to service@seca.com.

► Use only original accessories and seca spare parts, otherwise seca

will not grant any warranty.

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English

CAUTION!

Hazard to patient, malfunction

Keep other medical devices, e.g. high-frequency surgical devices,

►

at a minimum distance of approx. 1 meter to prevent incorrect measurement or wireless transmission interference.

► Keep high-frequency devices such as cellphones at a minimum

distance of approx. 1 meter to prevent incorrect measurement or wireless transmission interference.

► The actual transmission output of high-frequency equipment may

require minimum distances of more than 1 meter. For details, go to www.seca.com.

Preventing electric 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 details on the

power pack.

► Never touch the power pack with wet hands.

► Do not use an extension cable and multiple outlets. This also applies

to the USB connection on the touchscreen display.

► Make sure that the power cable is not crushed and cannot be

damaged by sharp edges.

► Do not operate the device above an altitude of 3000 m.

Preventing injuries and infections WARNING!

Hazard to patient

Subject the device to a hygiene treatment after each measurement

►

(see “Troubleshooting” on page 51).

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

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

palms of their hands or the soles of their feet.

► Ensure that the device is steady and level.

► The device is not designed as a standing aid. Assist people with

limited mobility, e.g. when they are getting up from a wheelchair.

► Ensure that the weighing platform is dry before the patient steps

onto it.

► Ensure that the patient has dry feet before stepping onto the

weighing platform.

► Ensure that the patient does not step directly onto the edges of the

weighing platform.

► Ensure that the patient steps onto the weighing platform slowly and

safely.

► Route the network and power cables such that no one can trip over

them.

WARNING!

Risk of infection

Before and after every measurement, wash your hands to reduce

►

the risk of cross-contamination and nosocomial infections.

► Hygienically reprocess the scale regularly as described in the re-

spective section in this document.

► Make sure that the patient has no infectious diseases.

► Make sure that the patient has no open wounds or infectious skin

alterations, which may come into contact with the device.

Safety information • 7

Preventing device damage ATTENTION!

Damage to device

Make sure that fluids never get inside the device. These can destroy

►

the electronics.

► Switch off the device before you disconnect the power pack from

the power supply.

► If the device is not be used for an extended period, disconnect the

power pack from the power supply. Only then is the device deenergized.

► Do not drop the device.

► Do not subject the device to shocks or vibrations.

► Do not place the device in direct sunlight and make sure that it is not

placed in the direct proximity of a heat source. The excessive temperatures could damage the electronics.

► Perform a function check at regular intervals as described in the cor-

responding section in the “Instructions for Use for Physicians and Assistants”. Do not operate the device if it is not working properly or is damaged.

► Avoid rapid temperature changes. If the device is transported so

that a temperature difference of over 20 °C occurs, the device must be left to stand for at least 2 hours before it is switched on, otherwise condensation may form; this can damage the electronics.

► Use only disinfectants free of chlorine and alcohol and which are ex-

plicitly suitable for acrylic sheet and other sensitive surfaces (active ingredient: quaternary ammonium compounds, for example).

► Do not use aggressive or abrasive cleaning agents.

► Do not use organic solvents (e.g. white spirit or petroleum spirit).

Dealing with measuring results WARNING!

Hazard to patient

The seca 515/514 is not a diagnostic device. The device assists the attending physician in reaching a diagnosis.

► To reach a precise diagnosis and to initiate therapies, the attending

physician must have thorough examinations conducted and take the results of these into consideration, as well as using the seca 515/

514

► The responsibility for diagnoses and the therapies derived from

them lies with the attending physician.

CAUTION!

Hazard to patient

To prevent misinterpretations, measured results for medical purposes may only be displayed and used in SI units (weight: kilograms, height: meters). Some devices have the option of displaying measured results in different units. This is purely an additional function.

► Only use measurements in SI units.

► The user takes sole responsibility for the use of measured results in

non-SI units.

ATTENTION!

Loss of data

Before you save and re-use values measured with the seca 515/514

►

(e.g. in the seca PC software or in a hospital information system), ensure that the measured values are plausible.

► If measured values have been transmitted from the seca 515/514

device to seca PC software or to a hospital information system, ensure before re-using them that the measured values are plausible and assigned to the correct patient.

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ATTENTION!

Measurements from third-party devices not compatible

Bioimpedance measurements performed by devices from different manufacturers are not compatible. Follow-up measurements performed on a device other than a seca medical Body Composition Analyzer may lead to inconsistent data and misinterpreted measured results.

► Ensure that follow-up measurements are also performed on a seca

medical Body Composition Analyzer.

Dealing with 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 risk of suffocation.

NOTE:

Store the original packaging for future use (e.g. returning for maintenance).

Safety information • 9

3. DEVICE OVERVIEW

91110 12

Front

Rear

Rear of weighing platform

3.1 Controls

No. Control Function

Switches device on: press button briefly

ON/OFF button with LED

Touchscreen display Central control and display element, can be swiveled 180° to left and right

Switches device to standby: press button briefly Switches device off: press button and hold

10 •

English

No. Control Function

For connecting a USB memory stick (contained in the scope of delivery) for administering the following data:

• creating seca patient files on the device

USB interface

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 the device

• saving measured results to the USB memory stick

• reading out log files from the device (administrator function)

3 pcs. with finger spacers, for bioimpedance measurement The patient selects an electrode pair depending on their height

Device overview • 11

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: indicates whether there is a connection to a seca 360° stadiometer

12 •

English

Symbol Meaning

Data connection symbol: indicates the current type of connection to the seca patient database (in this case Ethernet connection between PC and Additional possible connection types:

seca 115

• seca 360° wireless connection between PC and seca 115

• USB memory stick connected to device

Weight display

weight/height tab

Automatically active after device is switched on For determining weight and height of patient

bia tab

For performing a bioimpedance analysis

patient tab

For assigning the measured results to a seca patient file

evaluation tab

For evaluating measured results and analysis results and for saving data

menu changeover button

Appears if secondary menu is available

• Primary menu: contains the functions commonly used in the current context

• Secondary menu, contains the following functions:

settings

- print

- save

Menu bar with context-dependent buttons and menu changeover button

Hold value display

Weighing range currently in use:

• 1: finer divisions of the weight display at a lower capacity

• 2: maximum capacity

Non-verifiable function is active (for verified models only)

Display of patient's height

• Can be entered manually

• Can be received by a seca 360° stadiometer

Display of patient's body mass index (BMI) Calculated automatically as soon as a weight is available and a height value has been received or entered

Device overview • 13

3.3 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 link

between a PC and

seca 115

Tab

LED green: device on standby

LED off: device off

White: connection available

Red: data being transmitted on 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

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English

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

Green: Value within normal range

Display, evaluation

Orange: Value slightly elevated

Red: Value outside normal range

Device overview • 15

3.4 Menu structure

System

Unit changeover

Ethernet network

seca CLS network

Wireless network

Monitor & sound

Change GAL value

Calibrate device

Set the quality check

Read off calibration counter

Show/hide default module selection

before BIA measurement

settings

user

Activate/deactivate modules for default module selection

Default module selection

Set weight units

Set energy units

Set height unit

Set setup location

Set language

Region

Set date format

Set time format

Set name format

Set name hyphen

Set date

Date/time

Set time

admin

Enter IP address

View current settings

Activate/deactivate DHCP

Set up Ethernet

Enter netmask

admin PIN

Enter domain name server

Enter IP address

Enter default gateway

Enter port

Activate/deactivate wireless module

Set up wireless group

View wireless devices

Set display brightness

Set volume

Export system log file

Versions

Change administrator PIN

System

Calibrate touchscreen display

Reset admin settings

Service: primary functions

For authorized service

engineers only

For authorized service

engineers only

service

Update device software

Export/import settings

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English

3.5 Identification on the device and the type plate

0102 0123

use compatible seca adapter only

12 V min. 1,25 A

Text/symbol Meaning

Mod Model number

Approval Type Type designation of design approval (

S/N Serial number, consecutive

ProdID Product identification number, consecutive

Follow instructions for use

Medical electrical device, type BF

Insulated device, protection class II

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 (verified models)

seca 515 only)

FCC symbol (USA)

FCC ID For USA: device license number from the Federal Communications Commission (FCC)

IC For Canada: device license number from Industry Canada

Operate device only with an original seca power pack

USB interface

Do not dispose of device with household waste

Device overview • 17

3.6 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

18 •

English

4. MAKING THE DEVICE OPERATIONAL

seca 115

User Docs

seca

515/514

a b

ghf

4.1 Scope of delivery

No. Component Pcs.

medical Body Composition Analyzer 1

Power pack 1

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

DVD with user documentation in PDF format:

• Instructions for Use for Physicians and Assistants

• Administrator Manual

• additional information

Instructions for Use for Physicians and Assistants, hard copy 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

Making the device operational • 19

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 56.

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 connector 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.

ATTENTION!

Incorrect measurement due to force shunt

If the device and its housing are 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.

ATTENTION!

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.

20 •

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.

English

4.4 Operating the device in a PC network

The device does not have “on-board” patient and user administration. If you wish to administer 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 software and the device itself should only be installed and

The configured by experienced PC administrators or hospital technicians.

ATTENTION!

Loss of data

Incorrect installation or incorrect changes to the installation can lead to loss of data and, as a result, to misdiagnoses.

► Make sure the installation or changes to the installation are carried

out by an experienced administrator or hospital technician.

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 to be directly integrated in a PC network, the steps below are necessary.

• Install the

• Administer the

• Configure the

seca 115 PC software on the PC

seca 115 PC software

seca 515/514

• Set up Ethernet or seca wireless network

Details on the steps mentioned can be found in the section entitled “Configuring the device” from page 28 and in the Administrator Manual for the

seca 115

PC software.

seca 115

Making the device operational • 21

Print If the device is connected to the seca 115PC software via seca 360° wireless

seca 115

Printer

print

Indirect connection via USB

memory stick

network or Ethernet, you can use the special print function of the seca 115 PC software and print out detailed results reports on a PC printer.

The print function is a component of the so-called seca mediator service, a function module of the

seca 115 PC software. The seca mediator service

performs the tasks outlined below.

• Calculating bioimpedance analysis from the raw data for impedance of the

device

• Graphical processing of the bioimpedance analysis

• Collation and printing of a detailed results report

Printing of a results report can be started directly from the device. The raw data for impedance are sent to the

seca 115 PC software and the seca

mediator service starts automatically.

In order to be able to use this function via Ethernet, the device must be incorporated in a seca CLS network. Details on this can be found in the section entitled “Setting up seca CLS network (via Ethernet only)” from page 38 and in the Administrator Manual for the

seca 115 PC software.

If the device is not to be integrated directly 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, which means that 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 patient files can be saved on them. Details on this can be found in the Administrator Manual for

seca 115 PC software.

the You can synchronize the seca patient database on the USB memory stick

with the seca patient database of the

seca 115 PC software.

The steps below are necessary.

• Install the

• Administer the

• Configure the

seca 115 PC software on the PC

seca 115 PC software

seca 515/514

• If already available, load seca patient files from the seca 115 PC software

onto the USB memory stick

Details on the steps mentioned can be found in the section entitled “Configuring the device” from page 28 and in the Administrator Manual for the

seca 115

PC software.

22 •

English

4.5 Operation using a seca 360° stadiometer

seca 115

As an alternative to manual entry, you can use a seca 360° stadiometer to determine height and transfer the height to the device via network.

Height is taken into account when analyzing the bioimpedance measurement. If the device is connected to the together with the other measured results in a seca patient file and transmitted

seca 115 PC software.

to the

The steps below are necessary.

• Setting up

• Setting up the seca 360° wireless network

Details on the steps mentioned can be found in the section entitled “Configuring the device” from page 28 and in the instructions for use for the stadiometer and in the Administrator Manual for the seca 115 PC software.

seca 515/514 and establishing a power supply seca 360° stadiometer

seca 360° wireless

seca 115 PC software, height is recorded

seca 360°

Making the device operational • 23

5. OPERATING CONCEPT

max. 180°!

5.1 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.

ATTENTION!

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

5.2 Switch on 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 briefly turns 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

permanently white and the

2. Press the bia tab in the display. The bioimpedance analysis function is available if the

message is no longer displayed and the Module selection dialog window appears.

The device is ready for operation.

end stop.

weight/height tab is shown in the display.

Self-test active

5.3 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 tab, buttons).

24 •

English

5.4 Selecting extended functions

Functions commonly used in a certain context are accessible in the primary menu. Additional functions are accessible in the secondary menu.

1. Press the

2. Press the

5.5 Entering text

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

NOTE:

The assignment of functions to the primary and secondary menus is specified at the factory and cannot be changed.

Menu changeover button.

The secondary menu is displayed.

Menu changeover button again.

The functions in the primary menu are shown again.

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.

Operating concept • 25

5.6 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.

5.7 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.

You can find additional information on the measurement procedure in the Instructions for Use for Physicians and Assistants.

26 •

English

5.8 Automatic standby

5.9 Switching off the device

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 user currently logged in is automatically logged out.

• the LED of the ON/OFF button is green.

• the touchscreen display goes out.

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 button turns green. The touchscreen display goes out. The device is on standby.

► Press and hold the ON/OFF button

The LED of the button goes out. The touchscreen display goes out. The device is switched off.

NOTE:

When switching on again from standby, the

weight/height tab is active

immediately. When switching a device which has been switched off back on again, the internal PC boots up again. This takes several seconds.

Operating concept • 27

6. CONFIGURING THE DEVICE

6.1 Adapting the 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

dialog window appears and all evaluation modules are activated. 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.

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

menu changeover button.

The secondary menu is displayed.

2. Press the

The

settings button.

User menu appears.

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

3. Press the desired setting.

–

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. The default module selection can only be adapted in the

4. Press the

apply button.

settings menu.

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

28 •

English

Creating default module selection 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

menu changeover 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 the course of the bioimpedance

measurement as outlined in the table below.

Setting

Evaluation module

Energy

Health risk

Raw data for impedance

• = activated,

- = deactivated

•

Physical activity level (PAL) is interrogated

No interrogation of physical activity level (PAL)

Waist circumference (WC) is interrogated

No interrogation of waist circumference (WC)

Duration of measurement: max. 17 s

Duration of measurement: max. 75 s Raw data for impedance available

Effect

for 19 frequencies

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

dow. Dialog window is skipped if the Energy and Health risk evaluation modules are deactivated.

5. Press all modules you wish to deactivate.

The tick in the checkbox is no longer displayed.

NOTE:

Press on a module again to reactivate it.

Configuring the device • 29

6. Press the apply button.

The module selection is saved and will be 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

bia). The most recently

active tab is active again.

6.2 Administering user accounts and access rights

The device has no “on-board” user administration. User accounts can only be set up and edited in the seca 115 PC software.

When setting up user accounts, different PINs and passwords must be assigned for the usage and administration of the system. The table below provides an overview.

Password/PIN Use Source Change in

seca 515/514:

User PIN

USB PIN

Admin PIN

User password

Admin password

access to seca 115 patient database:

•Ethernet

• seca wireless network

• USB memory stick

seca 515/514:

access to

seca 115 patient database:

• USB memory stick

seca 515/514:

device configuration

seca 115:

administering measurements and patient data

seca 115:

administration of PC software

Automatic assignment by admin when setting up a

seca 115 user account

Initial USB PIN (0000) is supplied with the USB stick

seca 115

Initial admin PIN (00000) is supplied with the

514

seca 515/

seca 515/514

Created by Admin in seca 115 seca 115

Initial Admin password is supplied with the seca 115

seca 115

cancel button or

Additional information on user administration and access rights can be found in the Administrator Manual for the

6.3 Calling up the Administrator menu

1. Press the menu changeover button.

The secondary menu is displayed.

2. Press the

The secondary menu

3. Press the

seca analytics 115 PC software.

settings button.

settings is displayed.

admin button.

30 •

English

The password request appears.

4. Enter your administrator PIN (factory setting: “00000”).

5. Press the Enter key on the numerical keypad.

The entry is accepted.

The

admin dialog window appears.

6. Press the drop-down menu.

The drop-down menu opens.

7. In the drop-down menu, select the desired menu elements as described

in the sections below.

Configuring the device • 31

6.4 Making default settings

Setting units of measurement

1. Call up the Administrator menu.

The

Units dialog window is active.

The current settings for weight, energy and height are displayed (button gray = pressed).

2. Press the desired settings.

CAUTION!

Hazard to patient

► Only use measurements in SI units.

► The user takes sole responsibility for the use of measured results in

non-SI units.

3. Press the

apply button.

The new settings are active.

Making regional settings 1. Call up the Administrator menu.

2. In the drop-down menu, select the

Region dialog window appears.

The

3. In the

Setup location drop-down menu, select the country in which you

are operating the device.

Region element.

32 •

English

NOTE:

The selection of the setup location has an impact on which references the device uses to evaluate measured results. For information on the topic of references, see the Instructions for Use for Physicians and Assistants.

4. In the

Dialogue language drop-down menu, select the desired language.

5. In the Date format drop-down menu, select the desired date format.

6. In the Time format drop-down menu, select the desired time format.

Configuring the device • 33

7. In the Name format drop-down menu, select the desired sequence for the

patient's name and surname.

Patients' first names and surnames will be displayed in the device's lists and dialog windows in accordance with the sequence you select.

8. In the

Name hyphen drop-down menu, select the desired hyphenation.

34 •

In lists and dialog fields, patients' first names and surnames will be separated by the selected character.

ATTENTION!

Loss of data, incorrect assignment of measurements

The settings for name sequence and name hyphens are not automatically synchronized with the settings in the PC software. If the settings do not match, patients may be confused and measurements assigned to the incorrect seca patient file.

► Ensure that the same settings for name sequence and name hy-

phen are made both on the device and in the PC software.

English

9. Press the apply button.

10. Switch the device off and back on again.

The settings are adopted.

Setting the date and time 1. Call up the Administrator menu.

2. In the drop-down menu, select the

3. Press the field for the value you wish to set:

–

Date Time

–

The numerical keypad appears.

4. Enter the current value.

5. Press the Enter key on the numerical keypad.

The set value appears in the corresponding field

6. Repeat steps 4. and 5. for every other value you wish to change.

7. If you have selected the time format

am / pm setting matches actual time.

ATTENTION!

Loss of data, misinterpretation of measurements

The settings for date and time are not automatically synchronized with the settings in the PC software. If the settings do not match, different date and time details may lead to measurements being misinterpreted.

► Ensure that the same settings for date and time are made both on

the device and in the PC software.

8. Press the

9. Switch the device off and back on again.

The settings are adopted.

apply button.

Date/time element.

12 h under Region, ensure that the

Configuring the device • 35

Setting display brightness and

volume

1. Call up the Administrator menu.

2. In the drop-down menu, select the

Monitor & sound dialog window appears.

The

Monitor & sound element.

3. Press the slide control of the desired variable and move it to the left or to

the right.

Variable Left Right

Brightness Dark (20 %) Light (100 %)

Volume Quiet (0 %) Loud (100 %)

4. Press the apply button.

The new settings are active.

6.5 Setting up the network

Requirements • seca 115 PC software installed on a PC

Network services The following table shows which network services are installed in combination

• For Ethernet network: PC with network card and Ethernet interface

seca 360° wireless network: PC with connected

•For

seca 360° wireless USB adapter 456

NOTE:

► To use the network functions, observe the user documentation for

the

seca 115 PC software.

► If a USB memory stick is connected to the device, you can no longer

with the

access data of the

seca 360° wireless network.

seca 115 PC software. Depending on the type of network envisaged,

seca 115 PC software via Ethernet oder

the links to these services need to be set up on the device (• = necessary,

- = not necessary).

seca 360°

wireless

Ethernet

network

Set up wireless network •

Set up Ethernet connection

Set up link to CLS server and

seca mediator service

a.seca mediator service available for seca 515/514 from SW version 1.1 and

for seca 115 from SW version 1.4

•

36 •

English

NOTE:

► It is possible to combine network cards. For example, you can link

seca 360° stadiometer to the device via seca 360° wireless net-

work and link the device itself to a PC on which the

seca 115 PC

software is installed via Ethernet.

► Details on setting up the individual services can be found on the

pages which follow.

Network-dependent functions The following table shows the functions of the device and of the seca 115 PC

software which require a network connection and states in what kind of network these functions are available (• = available,

Height transmitted to the device wirelessly

Start the print function of the

seca 115 PC software directly on the

device

Send individual seca patient file from

seca 115 PC software to the

the device

Search seca patient files from the device in the patient database of the

seca 115 PC software

Save seca patient files from the device in the patient database of the

seca 115

a.Available for seca 515/514 from SW version 1.1 and for seca 115 from

version 1.4

- = not available):

seca 360°

wireless

Ethernet

network

•

- •

•

••

Integrate device in an Ethernet

network

seca 115

NOTE:

Information about using the network-dependent functions can be found in the “Instructions for Use for Physicians and Assistants” for this device and for the seca 115 PC software.

1. Create the hardware link between the device and the network using an

Ethernet cable.

2. Call up the administrator menu on the device.

3. In the drop-down menu, select the Ethernet network element.

Configuring the device • 37

4. In the DHCP line, press the setting to suit your network.

– No DHCP server in the network: off, proceed with step 5. – DHCP server in the network: on, proceed with step 7.

5. Press the

set up button.

The dialog window for setting up the Ethernet network appears.

6. Make the applicable settings for your network.

7. Press the save button.

The new settings are active.

Setting up seca CLS network (via

Ethernet only)

38 •

To enable communication between the device and the seca 115 PC software via Ethernet, you must link the device to the CLS server and the seca mediator service. CLS server and seca mediator service are communication modules of the

seca 115 PC software.

Once the link to the two communication modules has been set up, the following functions can be used directly from the device:

• accessing the seca patient database of the

seca 115 PC software

• printing out a detailed results report directly from the device on a PC printer

(the printer is selected in the

seca 115 PC software does not need to be started for this. Only the PC

The

seca 115 PC software)

on which the two communication modules and the seca patient database are installed must be switched on.

English

Netzwerk-Drucker

Network printer

seca 115 client (optional) CLS server

seca mediator service seca patient database

IP address 192.168.2.12 Port: 60667

seca 115 client

sec 115 Client

seca 115 Client (optional) CLS-Server

seca mediator service

seca Patientendatenbank

IP-Adresse: 192.168.2.12

seca 115 Client

Port: 60667

The two communication modules and the seca patient database are installed automatically when you select the options

seca 115 PC software.

the

Server or Complete for installing

NOTE:

Also observe the Administrator Manual for the

seca 115 PC software.

The CLS server and seca mediator service are addressed via the same IP address and the same port. To set up this link, proceed as outlined below.

1. Call up the administrator menu on the device.

2. In the drop-down menu, select the seca CLS network element.

The current settings are displayed.

3. In the

IP address line, enter the appropriate IP address.

Configuration IP address

seca 115 PC software as a client/

server solution

seca 115

PC software as a stand-

alone solution

4. In the

port line, enter the line “n+100” (n = port for the PC selected under

3., default: 60667).

5. Press the apply button.

The new settings are active.

The IP address of the PC on which the seca 115 PC software was installed with the options Server or

Complete

IP address of the PC workstation

Configuring the device • 39

Setting up the seca 360° wireless

network

Use the wireless network function to link other seca 360° devices, e.g. stadiometers, to the seca 515/514 device wirelessly.

NOTE:

► If you wish to link t he device t o t he seca 115 PC software, set up the

seca wireless network from the PC software. Further information can be found in the Administrator Manual for the PC software.

► For faster data transmission, we recommend connecting the device

via Ethernet to the PC on which the

seca 115 PC software is in-

stalled. For information about this, see this document from page 37 and the Administrator Manual for the

► A description of the functional principle of the seca wireless network

seca 115 PC software.

can be found in the section entitled “Technical information” from page 56.

To set up a seca 360° wireless network, proceed as outlined below.

1. Ensure that all devices you wish to connect to the

seca 515/514 device are

switched off.

2. Call up the administrator menu on the

3. In the pull-down menu, select the

seca 515/514 device.

wireless network element.

The wireless network dialog window appears.

4. In the

send & receive line, press the on button.

5. In the wireless group line, press the set up button.

6. Press the desired wireless group (in this case wireless group “0”).

The program will suggest three channels.

40 •

English

ATTENTION!

Incorrect device assignment and faulty data transfer

You can select channel numbers other than those suggested by the system. This may cause devices to be assigned to incorrect wireless groups, resulting in unreliable data transmission.

► Check that the channel numbers are not being used for the other

two wireless groups.

► Make sure that the channel numbers are at least 30 apart from one

another.

7. Click on

next.

The software will wait for signals from other seca 360° devices in range.

8. Switch on all devices you wish to incorporate in a wireless group.

When the devices are detected, a beep will be heard. Detected devices (in this case

seca 360° stadiometer) will be shown in the

touchscreen display. The corresponding symbols in the header appear white.

9. Click on exit.

Configuring the device • 41

Detected devices are shown on the touchscreen display.

10. Click on back.

The

wireless network dialog window appears.

The seca wireless network for wireless group 0 is set up.

11. Click on

The

apply.

wireless network dialog window closes.

Viewing wireless devices 1. In the wireless devices line, press the View button.

All detected devices are displayed.

2. Click on

The

3. Click on

The

back.

wireless network start screen is displayed again.

apply.

wireless network dialog window closes.

42 •

English

6.6 System data

Entry in “scale log book” line

1. 140301 1.0 14.2 02.01.2005

Serial number

Software identification

Software versions of parts of the program which have to be verified

Date device was updated

Viewing versions 1. Call up the Administrator menu.

2. Press the drop-down menu.

The drop-down menu opens.

3. Press the

The

versions menu element.

versions dialog window appears.

Viewing software versions

The versions of the individual software components active in the device are displayed in the versions dialog window.

1. Read off the versions.

2. To exit the

The

versions dialog window, click on exit.

versions dialog window closes.

Making system settings 1. Call up the Administrator menu.

Viewing scale logbook

You can view versions for device software components which are relevant for verification in the scale log book line of the versions dialog window. The current entry is displayed as soon as the

versions dialog window opens.

1. Read off the current entry.

2. To view the sequence of versions, press the

history button.

– Press once: previous entry is displayed – Press several times: all entries are displayed consecutively.

3. Read off the versions.

NOTE:

The

history function is purely for information. It is not possible to

reactivate older versions.

4. To exit the

5. The

versions dialog window, click on exit.

versions dialog window closes.

2. Press the drop-down menu.

The drop-down menu opens.

3. Press the

system menu element.

Configuring the device • 43

The system dialog window appears.

Exporting the system log file

You can export the system log file at regular intervals. To do so, you require a USB memory stick with the following characteristics:

• file system: FAT16

• no old log files on the stick

To export the system log file, proceed as outlined below.

1. Connect the empty USB memory stick to the USB port of the

touchscreen display.

2. In the

system dialog window, press the Export button.

44 •

3. Wait until the

Export completed message appears.

4. Analyze and archive the system log file in line with your institution's policy.

5. Delete the system log file from the USB memory stick.

The memory stick is ready for the next export.

Changing administrator PIN

ATTENTION!

Malfunction due to incorrect configuration

Every user who knows the administrator PIN can access the administrator menu and administer the system.

► Upon initial use, assign a new administrator PIN, in order to prevent

access by persons without sufficient expertise.

► Only give the new administrator PIN to persons with sufficient

expertise in configuring the system.

To change the administrator PIN, proceed as outlined below.

1. Call up the Administrator menu.

English

2. In the drop-down menu, select the system element.

3. In the

system dialog window, press the Change button in the

administrator PIN line.

The numerical keypad appears.

4. Enter the previous administrator PIN (factory setting: 00000).

5. Press the Enter key on the numerical keypad.

The entry is accepted.

6. Enter the new administrator PIN.

7. Press the Enter key on the numerical keypad.

The entry is accepted.

8. Enter the new administrator PIN again.

9. Press the Enter key on the numerical keypad.

The entry is accepted. The message

Administrator PIN changed appears.

10. Switch the device off and back on again.

The new administrator PIN is active.

Calibrating touchscreen display

If the device has a delayed reaction or does not react at all to the controls in the touchscreen display being pressed, you can calibrate the touchscreen display. To do so, proceed as outlined below.

1. Call up the Administrator menu.

2. In the drop-down menu, select the

3. In the

system dialog window, press the Calibrate button in the

touchscreen display line.

system element.

Configuring the device • 45

The calibration display appears.

4. Press and hold the cross symbol.

The cross symbol changes position.

5. Press and hold the cross symbol.

The cross symbol changes position again

6. Repeat steps 4. and 5. until the cross symbol is no longer displayed.

The touchscreen display is calibrated.

7. Press the empty touchscreen display.

The

system dialog window is shown again.

Restoring factory settings

You can restore the factory settings for the functions below.

Function Factory setting

Setup location Others Language English Date format mm.dd.yyyy Time format 24 h Volume 50 % Pre-tare (Pt) 0 kg Height 0.0 cm Brightness of display (back)lighting 100 % Wireless module Off Administrator PIN 00000 CLS server and seca mediator service:

• IP address

•port

0.0.0.0 60767

DHCP yes Module selection for BIA measurement:

• display prior to BIA measurement

• active modules

raw data for impedance

yes

deactivated

1. Call up the Administrator menu.

2. In the drop-down menu, select the

system element.

3. In the system dialog window, press the Reset button in the admin settings line.

46 •

English

Factory settings will be restored. The message Factory settings successfully restored. appears.

4. Press the The

next button.

system dialog window is shown again.

Configuring the device • 47

Using service functions The Service: primary functions dialog window contains functions your service

engineer uses frequently.

The following functions may only be used by your service engineer. The functions are protected by a special access code (SEED).

• Correcting GAL value

• Readjusting the device

The functions below can also be used by you as administrator. To do so, proceed as described on the pages which follow.

• Setting the quality check for the BIA

• Updating device software

• Exporting system settings

• Importing system settings

The functions in this dialog window are included as extras with other service functions in the

service menu. Contact your service engineer if required.

Updating device software

This function allows you to install a software update on your device. We provide software updates on our website for you to download.

NOTE:

The firmware of the weight recording module

cannot be updated

using this function.

To install a software update, proceed as outlined below.

1. Load the software update onto a USB memory stick.

2. In the

Service: primary functions dialog window, press the update button.

Security information about the software update appears on the screen.

48 •

English

3. Read the security information carefully.

4. Press the

update button.

The update process starts.

5. Follow the instructions on screen.

Exporting system settings

You can use this function to export and archive all system settings for the device in order to reload them after a software update, for example, or in order to configure other devices in the same way. To do so, proceed as outlined below.

1. Connect the USB memory stick to the USB port of the touchscreen display.

2. In the

Service: primary functions dialog window, press the Export button.

All system settings are loaded onto the USB memory stick.

3. Archive the system settings in line with your institution's policy.

Importing system settings

You can use this function to reload archived system settings for the device after a software update, for example. If several devices are in operation, you can use this function to ensure that the system settings are identical on all devices. To do so, proceed as outlined below.

1. Load the archived system settings onto a USB memory stick.

2. Connect the USB memory stick to the USB port of the touchscreen display.

3. In the

Service: primary functions dialog window, press the import button.

Configuring the device • 49

All system settings are loaded onto the device.

4. Follow the instructions on screen.

6.7 Saving settings

Applying settings 1. Press the apply button.

The

Save successful dialog window appears.

2. Press the The administrator menu appears on the display again. You can make additional settings in the administrator menu or exit the

administrator menu as described in the section entitled “

administrator menu

Exiting the administrator menu 1. Press the exit button.

The

Unsaved changes dialog window appears.

2. Press the desired button:

–

yes: the changes will be saved. The settings\User menu appears in

the display again.

–

no: the changes will not be saved. The settings\User menu appears

in the display again.

3. Press the The most recently active tab is active again. The device is ready to measure.

next button.

Exiting the

”.

exit button.

50 •

English

7. TROUBLESHOOTING

7.1 Power supply and display

Problem Cause Remedy

Device cannot be switched on

Touchscreen display remains dark

Touchscreen display not reacting

Image on touchscreen display faulty

7.2 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 is 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 (press and hold the on/off button for approx. 3 seconds)

• Switch the device back on

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

Ambient temperature too high or too low

temperature between +10 °C and +40 °C

• Wait for around 15 minutes until the device has adapted to the 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 • 51

7.3 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 following 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 no longer shown in the patient tab

seca patient file is

Module selection deactivated

Default module selection specified in which some modules have been 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 assigned, but assignment not confirmed

evaluation module deactivated

evaluation module

Check setting and change if necessary (see “Adapting the default module selection for bioimpedance analysis” on page 28)

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

• Adapt default module selection (see “Creating default module selection” on page 29)

Spray the skin at the contact points with electrode spray

• If the

Energy evaluation module is not

required, continue and complete measurement

Energy evaluation module is

• If the required, activate the evaluation module (see “Creating default module selection” on page 29)

Health risk evaluation module is not

• If the required, continue and complete measurement

Health risk evaluation module is

• If the required, activate the evaluation module (see “Creating default module selection” on page 29)

Request the patient not to 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 to rule out measurement errors

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

Assign seca patient file again and press the

confirm button (see Instructions for Use for

Physicians and Assistants); only call up another tab after that

52 •

English

7.4 Data transmission

Problem Cause Remedy

Data transmission cannot be set up between device and seca 115

A seca patient file is displayed 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 language

seca

patient file cannot be

provided by the PC software

Software versions incompatible

For access to the seca patient database of the USB memory stick, use the USB PIN for the USB memory stick rather than the user PIN

No seca patient file set up yet

seca patient file is not yet assigned to you in the

seca 115

Windows firewall port blocking is active, ports used for communicating with the device blocked

No seca CLS network set up

seca CLS server of the seca 115 PC software not started

No keypad available for set language.

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

No seca CLS network set up

seca CLS server of the

seca 115 PC

software not started

Software version not current

Administrator: use compatible software version:

• device min. software version 1.1

• PC software min. software version 1.4

Manually assign the measurement/seca patient file to an attending physician in the

seca 115

Create seca patient file (see Instructions for Use for Physicians and Assistants)

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

Administrator: free the port used for communication with the device in Windows firewall

Administrator: set up seca CLS network (see “Setting up seca CLS network (via Ethernet only)” on page 38)

Administrator: start seca CLS server manually

• Provide seca patient file from the PC software (see Instructions for Use for Physicians and Assistants)

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

Administrator: set up Ethernet connection

Administrator: set up seca CLS network (see “Setting up seca CLS network (via Ethernet only)” on page 38)

Administrator: start seca CLS server manually

Administrator: use current software version:

• device min. software version 1.1

• PC software min. software version 1.4

Troubleshooting • 53

Problem Cause Remedy

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

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

seca patient

No seca 360° wireless network set up between device and the PC on which the seca 115 PC software is installed

No Ethernet connection set up between the device and the PC on which the

seca 115 PC software is

installed

Device connected to a standalone PC via Ethernet cable. The PC’s network card does not permit automatic crossover

No USB memory stick connected to the touchscreen display.

The PC on which the

seca 115 PC

software is installed is not switched on

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

Administrator:

seca 360° wireless network (see

set up “Setting up the seca 360° wireless network” on page 40)

Administrator: set up Ethernet connection (see “Integrate device in an Ethernet network” on page 37)

Administrator: use a crossover adapter (see “Technical information” on page 56)

Connect USB memory stick to the touchscreen display

Switch on the PC and start the seca 115 PC software

Administrator:

No seca CLS network set up

set up seca CLS network (see “Setting up seca CLS network (via Ethernet only)” on page 38)

seca CLS server of the software not started

Non-initialized USB memory stick being used

PIN not entered or entered incorrectly

Unsuitable USB memory stick being used

Interference from high-frequency emissions from other devices (e.g. cellphones)

seca 115 PC

Administrator: start seca CLS server manually

• Use the USB memory stick supplied

• Administrator: initialize USB memory stick using the

seca 115 PC software

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

• Use the USB memory stick supplied

• Use a FAT16 USB memory stick

Increase distance from high-frequency devices

54 •

English

7.5 Print

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

•Set up

seca 360° wireless network

(“Setting up the seca 360° wireless

No network connection set up between device and

seca 115 PC software

network” from page 40)

• Set up Ethernet connection (“Integrate device in an Ethernet network” from page 37)

Administrator:

No seca CLS network set up

set up seca CLS network (see “Setting up seca CLS network (via Ethernet only)” on page 38)

seca 115 PC software service (medi-

A ator service, calculation service, image service, print service) has not started

Administrator: start seca 115 PC software service manually

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 link set up between the PC software and the PC printer

In the case of repeat measurement: no seca patient file assigned

On initial measurement: seca patient file not created yet

No bioimpedance measurement performed

No height entered on device

seca 115

Set up link between and the PC printer

Call up the

patient tab and assign seca

patient file (see Instructions for Use for Physicians and Assistants)

Call up the

patient tab and create seca

patient file (see Instructions for Use for Physicians and Assistants)

Call up the

bia tab and perform the mea-

surement (see Instructions for Use for Physicians and Assistants)

Call up the

weight/height tab and enter

height (see Instructions for Use for Physicians and Assistants)

No height transmitted by the stadiometer

seca 360°

Measure the patient's height again and press the

send/print button (see Instruc-

tions for Use for Physicians and Assistants)

seca 115 PC software

8. OPTIONAL ACCESSORIES

Accessory Article number

Measuring stations

• seca 285

• seca 284

Length measuring rods

seca 274

•

• seca 264

seca analytics 115 PC software Application-specific license packages

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

Crossover adapter for Ethernet cable 08-06-16-469-119

Country-specific versions Country-specific versions

Optional accessories • 55

9. SPARE PARTS

Spare part Article number

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

seca 201 circumference tape measure 201-17-17-009

DVD with seca analytics 115 PC software and license for a permanent workplace

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

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

Country-specific versions

10.TECHNICAL INFORMATION

10.1 The seca 360° wireless network

seca 360° wireless

Maximum number of wireless groups per PC workstation and USB adapter

1 baby scale

1 personal scale

1 length measuring device

1 medical Body Composition Analyzer

Maximum configuration per wireless group

1 seca wireless printer (not recommended for

operation with the mBCA)

1 PC with seca USB wireless adapter and

seca 115 software

Number of channels per wireless group 3

Type of channel assignment

Channel numbers 0 - 99 Minimum spacing of channel numbers 30

• Frequency band

• Transmission power

• Maximum range

Automatic (recommended)

2.433 GHz - 2.480 GHz

(mBCA)

Manual

< 10 mW

10 m

10.2 Technical modifications

Combination of seca 515/514 (SW version 1.1 from Build 550) and seca 115 (SW version 1.4 from Build 560)

Downward-compatible No

New Save or discard measured results after quality check

• Graphical representation: Body composition chart (BCC), fat-free mass (FFM), fat mass

Modified

(FM), body mass index - WHO reference value for adults (BMI)

• hydration (HYD) parameter in the

Fluid evaluation module

56 •

English

Combination of

Downward-compatible No

New

Modified

No longer applicable Lean soft tissue (LST) parameter in

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

• Regional settings:

• Enter waist circumference when Health risk evaluation module activated

• Visceral adipose tissue (VAT) parameter in the Health risk evaluation module

• Skeletal muscle mass (SMM) parameter in the module

• Send individual seca patient file from the seca 115 PC software to the mBCA

• Start printing results reports directly on the device (

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

Name format, Name hyphen drop-down menus

10.3 Additional technical information

Additional technical information can be found in the “ Instructions for Use for Physicians and Assistants”:

• Hygiene treatment

• Maintenance/reverification

• Technical data

11.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

Function/rehabilitation evaluation

seca 515/514)

Function/rehabilitation evaluation module

12.WARRANTY

There is a two-year warranty period from delivery for defects attributable to poor materials or workmanship. 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.

13.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.

Disposal • 57

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17-10-01-xxx /11 S_Prüf 3

17-10-07-627-002b_11-2016S

Präzision für die Gesundheit

<fett>seca deutschland

Medizinische Waagen und Messsysteme seca gmbh & co. kg. Hammer Steindamm 9-25 22089 Hamburg · Germany

Telefon · +49 (0)40 20 00 00 0

Fax · +49 (0)40 20 00 00 50

E-mail · info@seca.com

Seca mBCA 514 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. DEVICE DESCRIPTION

1.1 Intended use

1.2 Description of function

Calculating 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

Administering patient data seca patient files can be created directly on the device for administering mea-

Evaluation Bioimpedance measurements are evaluated in graphical form based on sci-

Administration of user data Access data for users of the device is administered in the seca 115 PC

Compatibility This device (software version 1.1 from Build 550) is compatible only with ver-

1.3 User qualification

Administration/network connection The device may only be set up and incorporated in 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 instructions in these instructions for use

2.2 Basic safety instructions

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

Preventing electric shock WARNING!

Preventing injuries and infections WARNING!

Preventing device damage ATTENTION!

Dealing with measuring results WARNING!

Dealing with packaging WARNING!

3. DEVICE OVERVIEW

3.1 Controls

3.2 Symbols in the start display

3.3 Color symbols and other controls

3.4 Menu structure

3.5 Identification on the device and the type plate

3.6 Identification on the packaging

4. MAKING THE DEVICE OPERATIONAL

4.1 Scope of delivery

4.2 Establishing power supply

4.3 Setting up the device

4.4 Operating the device in a PC network

print

4.5 Operation using a seca 360° stadiometer

5. OPERATING CONCEPT

5.1 Swiveling the touchscreen display

5.2 Switch on device

5.3 Selecting functions

5.4 Selecting extended functions

5.5 Entering text

5.6 Entering numbers

5.7 Measuring procedure

5.8 Automatic standby

5.9 Switching off the device

6. CONFIGURING THE DEVICE

6.1 Adapting the default module selection for bioimpedance analysis

Creating default module selection To create an in-house default module selection, proceed as outlined below.

6.2 Administering user accounts and access rights

6.3 Calling up the Administrator menu

6.4 Making default settings

Setting units of measurement

Making regional settings 1. Call up the Administrator menu.

Setting the date and time 1. Call up the Administrator menu.

6.5 Setting up the network

Requirements • seca 115 PC software installed on a PC

Network services The following table shows which network services are installed in combination

Network-dependent functions The following table shows the functions of the device and of the seca 115 PC

Viewing wireless devices 1. In the wireless devices line, press the View button.

6.6 System data

Viewing versions 1. Call up the Administrator menu.

Viewing software versions

Making system settings 1. Call up the Administrator menu.

Viewing scale logbook

Exporting the system log file

Changing administrator PIN

Calibrating touchscreen display

Restoring factory settings

Using service functions The Service: primary functions dialog window contains functions your service

Updating device software

Exporting system settings

Importing system settings

6.7 Saving settings

Applying settings 1. Press the apply button.

Exiting the administrator menu 1. Press the exit button.