seca 515 and 514 Administrator Manual Oct 2007

TABLE OF CONTENTS 1. Seals of quality (515)... 3 2. Seals of quality (514)... 4 3. Device description... 3.1 Congratulations!... 3.2 Application... 3.3 Functional description... Calculating weight and height... Bioelectric impedance analysis... Patient data management... Analysis... User data management... Data transmission and network functions . . 3.4 User qualification... Administration/network connection... Operation... 3.5 Contraindications...

5 5 5 5 5 5 5 6 6 6 6 6 6 7

4. Safety information... 8 4.1 Safety rules in these instructions for use... 8 4.2 Basic safety instructions... 8 Handling the instrument... 8 Preventing electric shock... 9 Preventing injuries and infections... 9 Preventing device damage... 9 Use of measured results... 10 Handling packaging material... 10 5. Overview... 11 5.1 Operating elements... 11 5.2 Symbols in the Start display... 13 5.3 Color symbols and additional operating elements 15 5.4 Identification on the device and the type plate 16 5.5 Menu structure... 17 6. Before you really get started... 18 6.1 Scope of delivery... 18 6.2 Establishing power supply... 19 6.3 Setting up device... 19 6.4 Operating the device in a PC network... 20 Network connection via Ethernet or seca wireless network... 20 Indirect connection via USB memory stick 21 6.5 Operation using a seca 360° wireless printer . 21 6.6 Operation using a seca 360° length measuring device... 22 7. Operating concept... 7.1 Swiveling the touchscreen display... 7.2 Switching on the device... 7.3 Selecting functions... 7.4 Selecting extended functions... 7.5 Entering text... 7.6 Displaying special characters... 7.7 Entering numbers... 7.8 Measurement procedure... 7.9 Automatic standby... 7.10 Switching off the device...

23 23 23 24 24 25 25 26 26 27 27

8. Configuring device... 8.1 Adapting standard module selection for BIA . Showing/hiding standard module selection Creating standard module selection... 8.2 Managing user accounts and access rights. .

28 28 28 29 30

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8.3 Calling up the Administrator menu... 8.4 Making default settings... Setting the weight unit... Making regional settings... Setting the date and time... Setting the display brightness and volume 8.5 Setting up network functions... Requirements... Connecting the device to a PC via Ethernet Setting up seca CLS network (only via Ethernet connection)... Setting up the seca wireless network... View wireless devices... 8.6 System data... Querying versions... Making system settings... 8.7 Saving settings... Applying settings... Exiting the administrator menu...

30 32 32 32 34 35 35 35 36

9. Troubleshooting... 9.1 Power supply and display... 9.2 Weight and height... 9.3 Bioelectric impedance analysis... 9.4 Data connection... 9.5 seca 360°wireless printer...

46 46 46 47 48 49

36 38 40 41 41 41 45 45 45

10. Technical information on seca wireless network 50 10.1 Introduction... 50 10.2 seca wireless groups... 50 10.3 Channels... 50 11. Accessories... 51 12. Spare parts... 51 13. Additional technical information... 51 14. Disposal... 51 15. Warranty... 52

English

1. SEALS OF QUALITY (515) With seca products, you are not only purchasing technology that has been perfected for more than 100 years, but a quality that has been officially and legally certified and also bears the quality seals from many institutions. seca products meet European directives, standards and national laws. When you buy seca, you buy the future. Scales that bear this symbol conform to the European Directive 2009/23/ EC on non-automatic weighing instruments. seca scales with this symbol meet the high quality and technical requirements that are demanded of calibratable scales. Scales that bear this symbol meet the strict requirements of Calibration Class III and can be used for medical measurements subject to legal control.

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Products bearing this symbol fulfill the applicable regulatory requirements of the European Community, especially the following: • Directive 2009/23/EC on non-automatic weighing instruments • Directive 93/42/EEC on medical products • DIN EN 45501 on metrological aspects of non-automatic weighing instruments seca’s professionalism is also recognized by official testing agencies. With this certificate, TÜV Süd Product Service, the agency responsible for medical products, confirms that seca adheres consistently to the strict legal requirements as a medical product manufacturer. seca’s quality assurance system includes the areas of design and development, production, sales, and service of medical scales and height measurement systems as well as software and measurement systems for the assessment of the state of health and nutrition. seca helps preserve the environment. Saving natural resources is very important to us. We therefore make every effort to save on packaging materials wherever it makes sense and whatever is leftover can be conveniently disposed of on site via the dual system.

Seals of quality (515) • 3

2. SEALS OF QUALITY (514) With seca products, you are not only purchasing technology that has been perfected for more than 100 years, but a quality that has been officially and legally certified and also bears the quality seals from many institutions. seca products meet European directives, standards and national laws. When you buy seca, you buy the future. Products bearing this symbol fulfill the applicable regulatory requirements of the European Community, especially the following:

0123

• Directive 93/42/EEC on medical products seca’s professionalism is also recognized by official testing agencies. With this certificate, TÜV Süd Product Service, the agency responsible for medical products, confirms that seca adheres consistently to the strict legal requirements as a medical product manufacturer. seca’s quality assurance system includes the areas of design and development, production, sales, and service of medical scales and height measurement systems as well as software and measurement systems for the assessment of the state of health and nutrition. seca helps preserve the environment. Saving natural resources is very important to us. We therefore make every effort to save on packaging materials wherever it makes sense and whatever is leftover can be conveniently disposed of on site via the dual system.

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3. DEVICE DESCRIPTION 3.1 Congratulations! With the Medical Body Composition Analyzer seca 515/514, you have just purchased a highly precise and simultaneously robust weighing instrument. For more than 170 years, seca has used its experience in the service of health care and, as a market leader, it has always set standards in many countries of the world with innovative developments for weighing and measuring.

3.2 Application Medical Body Composition Analyzer seca 515/514 is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations. The seca 515/514 device records weight, length and bioelectric impedance measurements and derivable parameters for automatic calculation, e.g. fat-free mass (FFM). The results are displayed graphically and assist the attending physician with the following medical aspects: • Determining energy consumption and energy reserves as a basis for nutrition advising • Assessing metabolic activity and success for a training program e.g. within the framework of rehabilitation or physiotherapy • Determining the fluids status of a patient • Determining the general state of health or, in the case of a previously known disease, assessing the severity The seca 515/514 is not a diagnostic device. To make an accurate diagnosis, in addition to the results of the seca 515/514, targeted examinations have to be ordered by the physician and their results taken into account.

3.3 Functional description Calculating weight and height

The device uses an electronic scale. The weight calculation is made across 4 weighing cells. The height is calculated via manual entry or via wireless transmission from a seca 360° length measuring device.

Bioelectric impedance analysis

The bioelectric impedance analysis is performed according to the 8-point method. The flow of the low alternating current and the measurement of the impedance are performed for each half 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 body size of between 1.60 m and 2.0 m can take up an optimal position on the device for a BIA measurement.

Patient data management

Patient data can be created directly on the device and saved on a PC using the supplied software seca analytics mBCA 115. Alternatively, patient data can also be saved on the USB memory stick provided. It is only possible to edit patient data with the PC software seca analytics mBCA 115.

Device description • 5

Analysis

User data management

The analysis of BIA measurements takes place in graphic form and is based on scientifically established formulas. In-house studies by seca have established formulas for determining the parameters of total body water (TBW), extracellular water (ECW), fat-free mass (FFM), and lean soft tissue (LST) for arms and legs. 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 analysis (BIVA), mass indices (FMI, FMMI), phase angle (Φ). You can find further information in the instructions for use for doctors and assistants. Access data for users of the devices are managed in the supplied PC software seca 115. As part of the creation of user accounts for the seca 115, a user PIN for the seca 515/514 is automatically generated. 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 PC software seca 115 is to be accessed using the device.

Data transmission and network functions

The device can exchange data wirelessly with the PC software seca 115. For this purpose, the PC software must be installed on a PC and the seca 360° Wireless USB Adapter 456 (contained in the scope of delivery) must be connected to the same PC. As an alternative to wireless transmission, a network cable (contained in the scope of delivery) can be used to connect the device to the PC (recommended for fast data transmission). The device can wirelessly transmit measurement results and patient data to a seca 360° wireless printer. 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)

3.4 User qualification Administration/network connection

The device may only be set up and connected to a network by experienced PC administrators.

Operation

The device and the PC software seca 115 may only be operated by persons with sufficient specialist expertise.

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3.5 Contraindications Impedance measurements may not be performed on patients who exhibit the following characteristics: • Electronic implants, e.g. cardiac pacemaker • Active prostheses Impedance measurements may not be performed on patients who are connected to one of the following devices: • Life-support electronic systems, e.g. artificial heart, artificial lungs • Portable electronic medical devices, e.g. ECG

Device description • 7

4. SAFETY INFORMATION 4.1 Safety rules 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 weighing instrument.

4.2 Basic safety instructions Handling the instrument

• Please take note of the information included in these instructions for use. • Keep the instructions for use in a safe place. DANGER! Danger of explosion Do not use the device in an environment enriched with one of the following gases: − Oxygen − Flammable anesthetics − Other flammable substances/gas mixtures CAUTION! Patient hazard, damage to device • Additional devices that are connected to medical electrical devices must be demonstrably in accordance with their corresponding IEC or ISO standards (e.g. IEC 60950 for data-processing devices). Furthermore, all configurations must correspond to the normative requirements for medical systems (see IEC 60601-1-1 or section 16 of the 3rd edition of IEC 60601-1, respectively). The person who connects additional devices to medical electrical devices is the system configurator and is therefore responsible for ensuring that the system matches the normative requirements for systems. We would like to point out that local laws regarding normative requirements take precedence. Please direct any queries to your local specialist dealer or Technical Service. • Please have maintenance, recalibration (only seca 515), and BIA measuring technology checks performed every two years. • The device does not contain any parts to be maintained by the user. Please only have maintenance, technical checks 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. • Only use original seca accessories and spare parts. Otherwise, seca will not grant any warranty.

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CAUTION! Patient hazard, malfunction • Keep other medical devices, e.g. high-frequency surgical devices, at a minimum distance of approx. 1 meter to prevent incorrect measurement or faults with wireless transmission. • Keep HF devices such as cell phones at a minimum distance of approx. 1 meter to prevent incorrect measurement or faults with wireless transmission.

Preventing electric shock

WARNING! Electric shock • Never touch the power supply with wet hands. • Do not use an extension cable and multiple outlets. This also applies for the USB connection on the touchscreen display. • Make sure that the power cable is not crimped and cannot be damaged by sharp edges. • Do not operate the device above a height of 3000 m.

Preventing injuries and infections

WARNING! Patient hazard • Prepare the device hygienically after each measurement (see “Troubleshooting” on page 46). • Ensure that the patient does not have any contagious diseases. • Ensure that the patient does not have any wounds on the palms on their hands or the soles of their feet. • Ensure that the positioning of the device is steady and even. • The device is not designed to be a stand assist. Assist people with limited mobility, e.g. when they are sitting 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 they step 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

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 device is not be used for a longer period of time, disconnect the power pack from the power supply. Only then is the device out of operation. • Do not let the device fall. • Do not subject the device to heavy jolts or vibrations. • Do not place the device in direct sunlight and make sure that it is not placed in direct proximity of a heat source. High temperatures could damage the electronics. • Avoid fast temperature changes. If the device is transported where a temperature difference of more than 20 °C occurs, the device must be left alone for two hours before it is switched back on. Otherwise, condensate may form; this can damage the electronics.

Safety information • 9

• Strong cleaning agents can ruin the scale's surfaces. Use only a soft cloth that you can dip in ethyl alcohol, if necessary.

Use of measured results

WARNING! Patient hazard The seca 515/514 is not a diagnostic device. The device assists the attending physician with creating a diagnosis. − For the creation of a precise diagnosis and for the initiation of therapies, in addition to the use of the seca 515/514, careful examinations must be conducted by the attending physician and the results of these taken into consideration. − The responsibility for diagnoses and the therapies derived from them lies with the attending physician. ATTENTION! Data loss • Before you save and re-use values measured with the seca 515/ 514 (e.g. in the PC software seca 115 or in a hospital information system), make sure that the measured values are plausible. • If measured values have been transmitted from the software seca 515/514 to the PC software seca 115 or to a hospital information system, make sure before re-use that the measured values are plausible and assigned to the correct patient.

Handling packaging material

WARNING! Danger of suffocation Packaging material made of plastic film (bags) presents a danger of suffocation. − Store packaging material out of the reach of children. − If the original packaging material is no longer available, only use plastic bags with safety holes in order to reduce the danger of suffocation. NOTE: Store the original packaging material for future use (e.g. returning for maintenance).

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5. OVERVIEW 5.1 Operating elements

1

2

8

3

4

5 Rear side

7

Front side

6

Rear side of weighing platform

9 No.

Controls

10

11

12 Function

1

ON/OFF button with LED

To switch on the device: Give button a brief press To switch the device into standby: Give button a brief press To switch off the device: Give button a long press

2

Touchscreen display

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

Overview • 11

No.

12 •

Controls

Function

3

USB interface

For connecting a USB memory stick (contained in the scope of delivery) for managing the following data: • Creating patient data on the device • Load patient data from the supplied PC software seca 115 onto the memory stick; call up data on device • Save measured results on the memory stick • Reading log files from the device (administrator function)

4

Pair of hand electrodes, right

3 pcs. with finger spacers, for BIA measurement The patient selects an electrode pair according to body size

5

Spirit level

Shows whether the device is positioned horizontally

6

Pair of foot electrodes, right

For heels and balls of feet, for BIA measurement

7

Pair of foot electrodes, left

For heels and balls of feet, for BIA measurement

8

Pair of hand electrodes, left

3 pcs. with finger spacers, for BIA measurement The patient selects an electrode pair according to body size

9

Foot screws, right

2 pcs, for precise adjustment

10

Power pack connection

For connecting the power pack

11

Ethernet interface

For integrating the device in a PC network

12

Foot screws, left

2 pcs, for precise adjustment

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5.2 Symbols in the Start display A

B

C

D

E

F

G

H Q P O

I

N M J

K

L Symbol

Meaning

A

Header, remains unchanged in all menu levels and tabs. The following data are displayed: • Patient data - Name - Weight - Height - BMI • Data connections • Date/time

B

Login symbol: Shows whether the user is logged in to a seca patient database (user PIN required)

C

Printer symbol: Shows whether there is a connection to a seca 360° wireless printer

D

Length measuring device symbol: Shows whether there is a connection to a seca 360° length measuring device

Overview • 13

Symbol

E

Meaning data connection symbol Shows the current connection type to the seca patient database (here: Ethernet connection to PC using seca 115. Additional possible connection types: •

seca 360° Wireless connection to PC using seca 115

•

USB memory stick connected to device

F

Weight display

G

weight/height tab Automatically active after switching on device For determining weight and height of a patient

H

bia tab For performing a bioelectric impedance analysis

I

patient tab For assigning the measured results to a patient file

J

analysis tab

For analyzing measured results and analysis results and for saving data change menu button

K

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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

L

Menu bars with context-dependent buttons and change menu button

M

Hold value display

N

Weighing range currently used: • 1: Finer divisions of the weight display at a lower capacity • 2: Maximum capacity

O

Non-calibratable function is active (only for calibrated models)

P

Patient body size display • can be entered manually • can be received by a seca 360° length measuring device

Q

Patient body mass index (BMI) display. Automatically calculated as soon as a weight is available and a height value has been received or entered

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5.3 Color symbols and additional operating elements Operating element/ display

Symbol

Meaning

LED white: Device on

ON/OFF button

LED green: Device in standby

LED off: Device off

White: Connection available Data connection symbol, here: seca 360° Wireless connection to a PC with

Red: Data being transmitted via the available connection

seca 115

Gray: Connection not available White: User is logged in Login symbol: Login to a seca patient database Gray: No user logged in White: Tab not selected Tab Red: Tab selected Light gray: Function available Buttons

Gray: Button pressed, function selected Dark gray: Function not available Red: Contact poor

Electrode indicator (for BIA measurement) Green: Contact good Gray: Function available Drop-down triangles Light gray: Function not available Function deactivated Checkbox Function activated

Overview • 15

Operating element/ display

Symbol

Meaning Selected function

Drop-down menu Drop-down menu opened

Red text: Value outside normal range Text color Gray text: Value within normal range

5.4 Identification on the device and the type plate Text/symbol Model Approval type

Meaning Model number Type designation of design approval (only seca 515)

Ser. no.

Serial number, consecutive

Product ID

Product identification number, consecutive Follow these instructions for use Electric medical device, type BF Insulated device, protection class II

FCC ID IC

For USA: Device approval number from the Federal Communications Commission (FCC) For Canada: Device approval number from Industry Canada Device conforms with the standards and guidelines of the EU FCC symbol (USA)

12 V min. 1,25 A

Only operate device with compatible original seca power pack

use compatible seca adapter only

USB interface Do not dispose of this device with household waste

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5.5 Menu structure System

Settings

Read off calibration counter Show/hide standard module selection before measuring BIA

User Standard module selection

Activate/deactivate modules for standard module selection

Unit changeover

Set weight unit Set energy unit Set height unit

Region

Set setup location Set dialogue language Set date format Set time format

Date/time

Set date Set time

Admin. Ethernet network

View current settings Activate/deactivate DHCP Set up Ethernet Enter IP address

Admin PIN Enter net mask seca cls network

Enter IP address Enter domain name server Enter port

Wireless network

Activate/deactivate wireless module

Enter standard gateway

Set up wireless group View wireless participants

Monitor and sound

Set display brightness Set volume

Versions

System

Export system log file Change administrator PIN Calibrate touch screen display

Service

For authorized service engineers only

Reset admin. settings

Overview • 17

6. BEFORE YOU REALLY GET STARTED... 6.1 Scope of delivery b

a

g

No.

a b c d e f g

18 •

c

d

seca 115

User Docs

f

e

Components Medical Body Composition Analyzer Power pack DVD with PC software seca 115 and license for a specific workplace DVD with user documentation in PDF format: • Instructions for use for doctors and assistants • Administrator manual • Quick guide • Additional information material

Pcs. 1 1 1

seca 360° Wireless USB Adapter 456

1 1 1 1

seca USB memory stick, 2 GB, initialized (USB PIN: 0000) Ethernet cable (1.5 m) for connecting to a TCP/IP network Instructions for use for doctors and assistants, printed (not shown)

1

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6.2 Establishing power supply WARNING! Using the wrong power supply may cause bodily injury or damage to the equipment Conventional power supplies may provide a higher voltage than is indicated on them. The device may overheat, catch fire, melt, or short circuit. − Use only the original seca plug-in power supply as contained in the scope of delivery and listed in section ”Spare parts” on page 51. The connection for the power pack is located on the underside of the weighing platform. To establish the power supply, proceed as follows: 1. Insert the the mains 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 mains socket.

6.3 Setting up device The device is fully assembled upon delivery. Spirit level

Air bubble

ATTENTION! Incorrect measurement due to force shunts If the device with the housing is placed on top of something, e.g. due to an uneven or soft floor covering, the weight will not be correctly measured. − Set the device up so that only its foot screws are in contact with the ground. 1. Place the device on firm and even ground. ATTENTION! Incorrect set-up may cause incorrect measurements The spirit level is very sensitive. Additional weights, such as hand towels, can result in incorrect scale calibration. − Make sure the scale is calibrated without any additional weight. 2. Calibrate 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

6.4 Operating the device in a PC network The device does not have “on-board” patient and user management. If you wish to manage electronic patient files and user accounts, the device must be connected to a PC on which the PC software seca 115 is installed. You have the following possibilities: • Network connection via seca wireless network or Ethernet • Indirect connection via USB memory stick The seca 115 software and the device itself should only be installed and configured by an experienced PC administrator. ATTENTION! Data loss The improper installation of or improper changes to the installation can cause data loss and, as a result, misdiagnoses. − Make sure installation or changes to installation are carried out by an experienced PC administrator.

Network connection via Ethernet or seca wireless network

If the device is to be directly integrated in a PC network, the following steps are necessary: • • • •

Install the PC software seca 115 on the PC Administer the PC software seca 115 Configure seca 515/514 Set up Ethernet or seca wireless network

Details on the stated steps can be found in the section ”Configuring device“ from page 28 and in the administrator manual of the PC software seca 115.

seca 115

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seca 115