Seca mVSA 535 User manual

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Software version 1.0 from Build 1163
Art no: 17-10-05-353-002g_10-2020 B
seca mVSA 535
seca mBCA 525
Instructions for use

2 •
Instructions for use for seca mVSA 535/
seca mBCA 525 . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1. About this document . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Description of device . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Intended use for the seca mVSA 535. . . . . . . . . 6
2.2 Intended use for the seca mBCA 525 . . . . . . . . 6
2.3 Description of function . . . . . . . . . . . . . . . . . . . . 7
Device components . . . . . . . . . . . . . . . . . . . . 7
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . 7
Bioimpedance measurement . . . . . . . . . . . . . 7
Vital signs measurement . . . . . . . . . . . . . . . . 7
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Weight and height . . . . . . . . . . . . . . . . . . . . . 8
seca user accounts . . . . . . . . . . . . . . . . . . . . 8
User IDs of EMR systems . . . . . . . . . . . . . . . 8
seca patient files . . . . . . . . . . . . . . . . . . . . . . 8
Patient data from EMR systems . . . . . . . . . . . 8
Measuring results . . . . . . . . . . . . . . . . . . . . . . 8
Data transmission and network functions . . . . 8
Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.4 User qualification . . . . . . . . . . . . . . . . . . . . . . . 10
Administration/network connection . . . . . . . 10
Measuring mode . . . . . . . . . . . . . . . . . . . . . 10
2.5 Contraindications. . . . . . . . . . . . . . . . . . . . . . . 10
3. Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 Safety precautions in these instructions for
use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 Basic safety precautions . . . . . . . . . . . . . . . . . 11
Handling the device . . . . . . . . . . . . . . . . . . . 11
Handling a wheeled stand . . . . . . . . . . . . . . 12
Preventing electric shock . . . . . . . . . . . . . . . 13
Prevent injuries and infections . . . . . . . . . . . 13
Preventing damage to device . . . . . . . . . . . . 14
Handling measuring results . . . . . . . . . . . . . 14
Handling packaging material . . . . . . . . . . . . 15
Handling batteries and rechargeable
batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4. Device overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.1 Monitor controls for seca mVSA 535/
seca mBCA 525 . . . . . . . . . . . . . . . . . . . . . . . 16
4.2 In-ear thermometer controls. . . . . . . . . . . . . . . 18
4.3 Measuring mat controls (bioimpedance
analysis). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.4 Fields in the touchscreen display . . . . . . . . . . . 20
4.5 Login/navigation: Buttons and symbols in the
touchscreen display. . . . . . . . . . . . . . . . . . . . . 20
4.6 Operating state: Symbols. . . . . . . . . . . . . . . . . 21
Operating state: Symbols in the touchscreen
display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating state: Symbols on the measuring
mat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.7 Measuring: Buttons and symbols. . . . . . . . . . . 23
Patient tab . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Vital signs tab . . . . . . . . . . . . . . . . . . . . . . . 24
BIA tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Measuring mat . . . . . . . . . . . . . . . . . . . . . . . 26
Analysis tab . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.8 Unsubmitted measurements list: Symbols . . . . 27
4.9 Markings on the device and on the type
plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.10 Markings on the blood pressure cuff . . . . . . . 30
4.11 Markings on the packaging . . . . . . . . . . . . . . 31
4.12 Other symbols . . . . . . . . . . . . . . . . . . . . . . . . 31
5. Starting up the device . . . . . . . . . . . . . . . . . . . . . . 32
5.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . 32
5.2 Setting up device. . . . . . . . . . . . . . . . . . . . . . . 33
Connecting the SmartBucket . . . . . . . . . . . . 33
Connecting the blood pressure cuff . . . . . . . 34
Connecting the temperature probe . . . . . . . 34
Connecting the in-ear thermometer . . . . . . . 35
Connecting the seca SpO2 sensor . . . . . . . . 35
Connecting the Masimo SET®
SpO2 sensor . . . . . . . . . . . . . . . . . . . . . . . . 36
Suspending the measuring mat in the
magnetic catch . . . . . . . . . . . . . . . . . . . . . . 37
5.3 Establishing a power supply. . . . . . . . . . . . . . . 38
5.4 Charging rechargeable batteries . . . . . . . . . . . 38
5.5 Setting the date and time. . . . . . . . . . . . . . . . . 39
5.6 Initial login . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.7 Configuration options. . . . . . . . . . . . . . . . . . . . 40
6. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.1 Switching the system on/off. . . . . . . . . . . . . . . 41
Switching on . . . . . . . . . . . . . . . . . . . . . . . . 41
Logging in . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Logging out/switching user . . . . . . . . . . . . . 43
Saving power/switching off . . . . . . . . . . . . . 43
6.2 Managing seca patient files . . . . . . . . . . . . . . . 44
Creating a seca patient file . . . . . . . . . . . . . . 44
Calling up a seca patient file . . . . . . . . . . . . 47
Editing a seca patient file . . . . . . . . . . . . . . . 47
Exporting a seca patient file . . . . . . . . . . . . . 48
Deleting a seca patient file . . . . . . . . . . . . . . 48
6.3 Measuring vital signs . . . . . . . . . . . . . . . . . . . . 49
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 49
Measuring blood pressure . . . . . . . . . . . . . . 50
Measuring temperature, oral/axillary
(COVIDIENTM FILACTM 3000, blue) . . . . . . . 55
Measuring temperature, rectal
(COVIDIENTM FILACTM 3000 red) . . . . . . . . 58
Measuring in-ear temperature
(COVIDIENTM GENIUS®3) . . . . . . . . . . . . . . 61
Entering temperature manually . . . . . . . . . . 65
Reading off pulse rate . . . . . . . . . . . . . . . . . 66
Measuring oxygen saturation (SpO2) . . . . . . 68
Weight and height . . . . . . . . . . . . . . . . . . . . 72
Stopping a measurement procedure . . . . . . 73
Assigning anonymous measurement
procedure to a seca patient file . . . . . . . . . . 73
6.4 Measuring bioimpedance. . . . . . . . . . . . . . . . . 73
Preparing a bioimpedance measurement . . . 74
Performing a measurement (with WiFi
direct connection to the measuring mat) . . . 75
Performing a measurement (without WiFi
direct connection to the measuring mat) . . . 77
Connecting the measuring mat . . . . . . . . . . 79
6.5 Adding weight and height . . . . . . . . . . . . . . . . 80
Receiving weight and height
(seca 360° proximity) . . . . . . . . . . . . . . . . . . 81
Receiving weight and height
(seca 360° wireless) . . . . . . . . . . . . . . . . . . . 82
Entering weight and height manually . . . . . . 83
CONTENTS

• 3
English
6.6 Analyzing measurement. . . . . . . . . . . . . . . . . . 84
Viewing current measuring results . . . . . . . . 84
Analyzing vital signs (history) . . . . . . . . . . . . 85
Analyzing a bioimpedance measurement . . . 87
7. Operation when connected to an EMR
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
7.1 Switching on the device. . . . . . . . . . . . . . . . . . 91
7.2 Measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Measuring with an active connection to an
EMR system . . . . . . . . . . . . . . . . . . . . . . . . 92
Measuring with an interrupted connection to
an EMR system . . . . . . . . . . . . . . . . . . . . . . 92
7.3 Logging in with EMR user ID . . . . . . . . . . . . . . 94
Scanning EMR user ID (recommended) . . . . 94
Entering EMR user ID manually . . . . . . . . . . 94
7.4 Calling up patient data from the EMR
system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Scanning patient ID (recommended) . . . . . . 95
Manually entering patient ID . . . . . . . . . . . . . 96
7.5 Saving measurements in the EMR system . . . . 97
Submitting the measurement directly to the
EMR system . . . . . . . . . . . . . . . . . . . . . . . . 97
Saving measurement temporarily and
submitting it later . . . . . . . . . . . . . . . . . . . . . 97
Using the Unsubmitted measurements list . . 98
8. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . 102
8.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
8.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . 104
8.3 Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
8.4 Removing/fitting probe holder (devices with
temperature probe) . . . . . . . . . . . . . . . . . . . . 105
Removing the probe holder . . . . . . . . . . . . 105
Fitting the probe holder . . . . . . . . . . . . . . . 105
8.5 Removing/fitting the magazine holder
(devices with in-ear thermometer) . . . . . . . . . 106
Removing the magazine holder . . . . . . . . . 106
Fitting the magazine holder . . . . . . . . . . . . 106
9. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . 107
9.1 Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
9.2 COVIDIENTM GENIUS®3 in-ear
thermometer . . . . . . . . . . . . . . . . . . . . . . . . . 107
10. Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
10.1 Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
10.2 COVIDIENTM GENIUS®3 in-ear
thermometer . . . . . . . . . . . . . . . . . . . . . . . . . 108
11. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 109
11.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
11.2 Measuring mat. . . . . . . . . . . . . . . . . . . . . . . 110
11.3 Bioimpedance measurement . . . . . . . . . . . . 111
11.4 Vital signs measurement . . . . . . . . . . . . . . . 112
General . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Blood pressure measurement . . . . . . . . . . 112
COVIDIENTM FILACTM 3000 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . . 113
COVIDIENTM GENIUS®3 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . . 113
Manual temperature input . . . . . . . . . . . . . 115
SpO2 measurement . . . . . . . . . . . . . . . . . . 115
11.5 Network connection. . . . . . . . . . . . . . . . . . . 116
11.6 Connection to the seca analytics 115
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
11.7 EMR system connection via
seca connect 103 software . . . . . . . . . . . . . . 118
11.8 seca 360° proximity connection. . . . . . . . . . 119
11.9 seca 360° wireless connection. . . . . . . . . . . 119
12. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . 120
12.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
12.2 Monitor interfaces and network ports. . . . . . 121
Interfaces and network ports . . . . . . . . . . . 121
Recommended WiFi settings . . . . . . . . . . . 121
12.3 Measuring mat. . . . . . . . . . . . . . . . . . . . . . . 122
12.4 Bioimpedance measurement . . . . . . . . . . . . 122
Measuring method . . . . . . . . . . . . . . . . . . . 122
Clinical studies . . . . . . . . . . . . . . . . . . . . . . 123
Accuracy of predictive formulas . . . . . . . . . 123
12.5 Vital signs measurement . . . . . . . . . . . . . . . 124
Blood pressure measurement . . . . . . . . . . 124
COVIDIENTM FILACTM 3000 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . 125
COVIDIENTM GENIUS®3 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . 126
Manual temperature input . . . . . . . . . . . . . 126
Masimo SET® SpO2 measurement . . . . . . 126
seca SpO2 measurement . . . . . . . . . . . . . 128
12.6 Analysis parameters. . . . . . . . . . . . . . . . . . . 129
12.7 Analysis modules. . . . . . . . . . . . . . . . . . . . . 130
12.8 seca 360° wireless system. . . . . . . . . . . . . . 130
12.9 Standards and directives . . . . . . . . . . . . . . . 131
13. Optional accessories and spare parts . . . . . . . 131
14. Compatible seca products . . . . . . . . . . . . . . . . 132
15. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
15.1 Measuring mat and device. . . . . . . . . . . . . . 133
15.2 Batteries and rechargeable batteries . . . . . . 133
15.3 Consumables . . . . . . . . . . . . . . . . . . . . . . . 133
16. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
17. Declaration of conformity . . . . . . . . . . . . . . . . . 134

4 •
For administrators: Configuring
seca mVSA 535 /seca mBCA 525 . . . . . . . . . 135
1. Preparing configuration . . . . . . . . . . . . . . . . . . . 135
1.1 Administrator login. . . . . . . . . . . . . . . . . . . . . 135
1.2 Configuration options. . . . . . . . . . . . . . . . . . . 137
Network functions . . . . . . . . . . . . . . . . . . . 137
Overview of access rights . . . . . . . . . . . . . 137
2. User accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
2.1 Activating initial user accounts . . . . . . . . . . . . 138
Changing the password for the Admin user
account . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Assigning a password to the User user
account . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
2.2 Working with user accounts. . . . . . . . . . . . . . 140
Setting up user accounts . . . . . . . . . . . . . . 140
Editing user accounts . . . . . . . . . . . . . . . . 140
Deleting user accounts . . . . . . . . . . . . . . . 141
3. Making settings for measuring mode . . . . . . . . 142
3.1 Making regional settings . . . . . . . . . . . . . . . . 142
3.2 Setting display brightness and volume . . . . . . 143
3.3 Calibrating the touchscreen display . . . . . . . . 144
3.4 Setting units of measurement. . . . . . . . . . . . . 146
3.5 Deactivating analysis modules . . . . . . . . . . . . 147
3.6 Making presets for vital signs measurement. . 148
Presets for blood pressure . . . . . . . . . . . . . 148
Presets for pulse rate (seca measuring
equipment only) . . . . . . . . . . . . . . . . . . . . . 152
Presets for SpO2 . . . . . . . . . . . . . . . . . . . . 153
Presets for temperature
(COVIDIENTM FILACTM 3000 only) . . . . . . . 154
Selecting color mode for Vital signs tab . . . 156
4. Managing system components . . . . . . . . . . . . . 157
4.1 Viewing system information . . . . . . . . . . . . . . 157
4.2 Updating the monitor software. . . . . . . . . . . . 158
4.3 Updating the measuring mat software . . . . . . 159
4.4 Retrofitting the SmartBucket
(seca mBCA 525 only) . . . . . . . . . . . . . . . . . . 160
4.5 Retrofitting the measuring mat
(secamVSA 535 only) . . . . . . . . . . . . . . . . . . 161
4.6 Retrofitting the in-ear thermometer
(secamVSA 535 only) . . . . . . . . . . . . . . . . . . 162
4.7 Data export and backup . . . . . . . . . . . . . . . . 163
Exporting patient and user data manually . . 163
Restoring patient and user data manually . 164
4.8 Power management. . . . . . . . . . . . . . . . . . . . 165
5. Setting up peripherals . . . . . . . . . . . . . . . . . . . . . 166
5.1 Setting up a LAN connection to the
network (stationary operation) . . . . . . . . . . . . 166
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 166
Activating the LAN connection . . . . . . . . . . 167
Deactivating the LAN connection . . . . . . . . 169
5.2 Setting up a WiFi connection (mobile
operation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 170
Activating the WiFi connection . . . . . . . . . . 171
Deactivating the WiFi connection . . . . . . . . 172
5.3 Setting up a connection to the seca
analytics 115 PC software . . . . . . . . . . . . . . . 173
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 173
Connecting the device automatically
(UDP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Connecting the device manually (TCP) . . . . 174
Activating automatic synchronization . . . . . 175
Setting up automatic export . . . . . . . . . . . . 177
5.4 Setting up a seca 360° proximity connection . 178
5.5 Setting up a seca 360° wireless connection. . 181
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 181
Activating/deactivating the
seca 360° wireless module . . . . . . . . . . . . 182
Setting up a seca 360° wireless
connection . . . . . . . . . . . . . . . . . . . . . . . . . 182
6. Connecting to an EMR system . . . . . . . . . . . . . . 184
6.1 Information about user and patient data. . . . . 184
6.2 Assigning a clear device name. . . . . . . . . . . . 185
6.3 Setting up a connection to the seca
connect 103 software . . . . . . . . . . . . . . . . . . 186
Entering connection data . . . . . . . . . . . . . . 186
Making workflow settings . . . . . . . . . . . . . 187
6.4 Configuring data transfer to the EMR
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
6.5 Use of certificates . . . . . . . . . . . . . . . . . . . . . 189
6.6 Summary: Device characteristics when
connected to EMR system . . . . . . . . . . . . . . 189
7. Factory settings . . . . . . . . . . . . . . . . . . . . . . . . . . 190
7.1 Overview of factory settings . . . . . . . . . . . . . . 190
7.2 Resetting the device . . . . . . . . . . . . . . . . . . . 191
7.3 Resetting the user interface . . . . . . . . . . . . . . 192
7.4 Exporting the system log/audit trail . . . . . . . . 192
7.5 Enabling VNC access . . . . . . . . . . . . . . . . . . 193

About this document • 5
English
17-10-05-353-002g_10-2020 B
INSTRUCTIONS FOR USE FOR seca mVSA 535/seca mBCA 525
English
Software version: 1.0 from Build 1163
Article number of this document: 17-10-05-353-002g_10-2020 B
1. ABOUT THIS DOCUMENT
NOTE
This document describes the maximal equipment of the
secamVSA 535/seca mBCA 525 product family: measurement of
blood pressure, temperature, oxygen saturation and bioimpedance.
Depending on the actual equipment of your device, some of this infor-
mation may not be relevant to your device. Pay attention to the infor-
mation in this document which is relevant to your device.
➔About this document ➔Servicing
➔Description of device ➔Troubleshooting
➔Safety precautions ➔Technical data
➔Device overview ➔Optional accessories and spare
parts
➔Starting up the device ➔Compatible seca products
➔Operation ➔Disposal
➔Operation when connected to an
EMR system
➔Warranty
➔Hygiene treatment ➔Declaration of conformity
➔Function check ➔For administrators: Configuring
seca mVSA 535 /
seca mBCA 525
Display conventions
Symbol Description
►Handling instruction
1.
2.
Handling instructions which have to be performed in
the specified sequence
a)
b)
Steps of a handling instruction which have to be
performed in the specified sequence
•
•First level of a list
–
–Second level of a list
Indicates points on the device or on device
components which require particular attention
Indicates areas on the display which require particular
attention
Indicates directions in overview graphics
Correct handling method
Correct handling result
Incorrect handling method
Incorrect handling result

6 • secamVSA 535/seca mBCA 525
17-10-05-353-002g_10-2020 B
2. DESCRIPTION OF DEVICE
2.1 Intended use for the seca mVSA 535
The medical Vital Signs Analyzer secamVSA 535 is mainly used in inpatient
facilities (hospitals, medical practices and care facilities) in accordance with
national regulations.
The medical Vital Signs Analyzer secamVSA 535 is used for non-invasive, dis-
continuous determination of arterial blood pressure and/or non-invasive
determination of oxygen saturation of arterial hemoglobin and/or determina-
tion of body temperature and pulse rate and determination of weight and
height.
When the Bioimpedance analysis function is included, the medical device is
also used to record bioelectric impedance measurements and to calculate
automatically parameters such as fat-free mass (FFM) which can be derived
from these measurements. The results are displayed in graphical form and
assist the attending physician with the following medical issues:
• Determining energy expenditure and energy reserves as a basis for
nutritional advice
• Assessing metabolic activity and the success of a training program, e.g.
within the framework of rehabilitation or physiotherapy
• Determining a patient's fluids status
The medical Vital Signs Analyzer secamVSA 535 is intended for use in chil-
dren 3 years and older and adults. The Bioimpedance analysis function is not
intended for use on children.
2.2 Intended use for the seca mBCA 525
The medical Body Composition Analyzer seca mBCA 525 is mainly used in
inpatient facilities (hospitals, medical practices and care facilities) in accor-
dance with national regulations.
The medical Body Composition Analyzer seca mBCA 525 records weight,
height and bioelectric impedance measurements and automatically calculates
parameters such as fat-free mass (FFM) which can be derived from these
measurements. The results are displayed in graphical form and assist the
attending physician with the following medical issues:
• Determining energy expenditure and energy reserves as a basis for
nutritional advice
• Assessing metabolic activity and the success of a training program, e.g.
within the framework of rehabilitation or physiotherapy
• Determining a patient's fluids status
The device is not intended for use on children.
➔Intended use for the seca mVSA 535
➔Intended use for the seca mBCA 525
➔Description of function
➔User qualification
➔Contraindications

Description of device • 7
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2.3 Description of function
Device components The secamVSA 535 consists of a monitor and a SmartBucket.
The seca mBCA 525 consists of a monitor and a storage compartment.
The monitor is for managing patient and user data and for preparing and ana-
lyzing measurements. The monitor is equipped with a touchscreen display.
The SmartBucket includes the measuring equipment for recording vital signs
and storage facilities for the measuring accessories.
In the maximum configuration, the vital signs blood pressure, body tempera-
ture, pulse rate and oxygen saturation can be recorded and bioimpedance
measurements performed. Your version of the device may have a more lim-
ited functional scope.
Power supply The monitor is powered by a connection to the power supply. The monitor
has a lithium-ion rechargeable battery to provide a mobile power supply.
The SmartBucket is supplied with power via a USB connection from the
monitor.
Bioimpedance measurement Bioimpedance measurement is performed with a measuring mat developed
by seca.
Bioimpedance measurement is carried out with the patient lying down, using
the 8-point method. The 4-point method (measuring the right half of the body)
is likewise possible. The low alternating current is provided and impedance is
measured by the electrode cables of the measuring mat. The electrode
cables are connected to two pairs of electrodes for each half of the body. The
electrodes are affixed to the patient's hands and feet.
Vital signs measurement Blood pressure is measured non-invasively with seca measuring equipment
and seca blood pressure cuffs.
Temperature is measured with COVIDIENTM measuring equipment and,
depending on the device version, as an oral/axillary (blue temperature probe),
rectal (red temperature probe) or in-ear thermometer procedure.
On device versions without integrated temperature measurement,
temperature values can be entered manually.
➔Device components
➔Power supply
➔Bioimpedance measurement
➔Vital signs measurement
➔Alarms
➔Weight and height
➔seca user accounts
➔User IDs of EMR systems
➔seca patient files
➔Patient data from EMR systems
➔Measuring results
➔Data transmission and network functions
➔Compatibility

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Depending on the device version, oxygen saturation is measured with
Masimo SET® or with seca measuring equipment and with the corresponding
SpO2 sensors and patient cables.
Depending on device version, pulse rate is determined using either oxygen
saturation or blood pressure.
Alarms The device is intended for discontinuous measurement of vital signs, so it
does not have an alarm function.
Weight and height Scales and measuring rods from the seca 360° wireless system can transmit
measuring results to the device wirelessly.
Scales and measuring rods with an internal interface module or a seca 452
external interface module can transmit measuring results to the device via
LAN or WiFi.
Alternatively, the patient's weight and height can be recorded manually.
seca user accounts The user accounts for the device can be synchronized automatically with the
seca user accounts of the seca analytics 115 PC software. This allows access
to both the device and the PC software with the same seca user account.
User IDs of EMR systems If the device is connected to an EMR system via the seca connect 103 soft-
ware, the user IDs of the EMR system can be used for measurements. Local
user accounts on the device are required for administration and service tasks.
seca patient files seca patient files and seca patient databases contain exclusively data neces-
sary for working with seca products or which were determined using seca
products.
In standalone mode or when connected to the seca analytics 115 PC soft-
ware, measuring results are managed in seca patient files. seca patient files
can be set up, edited, exported and deleted directly on the device.
The device can be configured so that the seca patient files of the device are
automatically synchronized with the seca patient files of the
seca analytics 115 PC software.
Patient data from EMR systems Depending on the EMR system in question, patient data from EMR systems
may be used via the export and import functions of the seca analytics 115 PC
software or via a connection to the seca connect 103 software.
Measuring results Measured results for the vital signs blood pressure (NIBP), temperature
(TEMP), pulse rate (PR) and oxygen saturation (SpO2) are displayed in
graphical form.
Bioimpedance measurements are analyzed in graphical form based on scientif-
ically-validated formulas. In-house studies by seca generated predictive formu-
las for determining the parameters total body water (TBW), extracellular water
(ECW), fat-free mass (FFM) and skeletal muscle mass (SMM) for arms, legs,
torso and the whole body. Further studies generated normal ranges for the fol-
lowing parameters: Bioelectric impedance vector analysis (BIVA), mass indices
(FMI, FFMI), phase angle (φ), fat mass (FM) and skeletal muscle mass (SMM).
Data transmission and network
functions
The device can be integrated in a network via a LAN interface or via WiFi in
order to use the following functions:
• Connection of the device to the seca analytics 115 PC software avail-
able as an option: Communication with the databases of the
seca analytics 115 PC software and use of the seca directprint function
• Connection of the device to the seca connect 103 software available as
an option: Using the user and patient data of an EMR system and
submitting measuring results to the EMR system

Description of device • 9
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•seca 360° proximity connection: Receiving weight and height from
scales and measuring rods with an internal interface module or a
seca 452 external interface module
Monitor and measuring mat – if there is one – communicate with each other
via a WiFi direct connection or via an infrared interface.
Measuring results for the parameters blood pressure, body temperature,
pulse rate and oxygen saturation are transmitted from the SmartBucket to the
monitor via a USB connection.
The device has a seca 360° wireless module and can receive measuring
results from compatible seca scales and measuring rods.
Compatibility seca analytics 115 PC software
This device (software version 1.0, Build 1163 or higher) is only compatible
with version 1.4 (Build 6657 or higher) of the seca analytics 115 PC software.
There is no downward compatibility with older versions of seca analytics 115.
seca connect 103 software
This device (software version 1.0, Build 1163 or higher) is only compatible
with version 2.2 or higher of the seca connect 103 software. There is no
downward compatibility with older versions of the seca connect 103 software.
Internal interface module/seca 452 interface module
This device (software version 1.0, Build 1163 or higher) is only compatible
with interface modules on which firmware version Q2_2020_Build_615 or
higher is installed.
seca mVSA 526 SmartBucket
medical Body Composition Analyzer seca mBCA 525 from serial number
10000000090505 can be retrofitted with the SmartBucket seca mVSA 526
(accessory kit for measuring vital signs).

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2.4 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 may only be used by persons with sufficient expertise.
Basic knowledge required for measuring vital parameters is not the subject of
these instructions for use.
Connecting the device to an EMR system affects the measuring sequence
and operation of the device: ➔Operation when connected to an EMR
system. People operating the device must be informed about these effects.
2.5 Contraindications
The device is not intended for permanent monitoring of patients.
The device is not intended for patient monitoring during either transport (for
example, in ambulances or helicopters) or transfer within an institution.
The device is not intended for operation in the vicinity of an MRI device or in a
pressurized chamber.
The SpO2 measuring function of the device is not intended for monitoring
apneas, detecting arrhythmias or for use during defibrillation or
electrocauterization.
This device is not suitable for persons with the following characteristics:
• Cramps
• Tremors
This device is not suitable for individuals who are connected to electronic life-
support systems, for example, artificial heart/lung.
Bioimpedance measurements may not be performed on individuals exhibiting
the following characteristics:
• electronic implants, e.g. cardiac pacemakers
• active prostheses
Bioimpedance measurements may not be performed on persons who are
connected to one of the following devices:
• electronic life-support systems, e.g. artificial heart, artificial lung
• portable electronic medical devices, e.g. ECG devices or infusion
pumps
Impedance measurements may only be performed on persons exhibiting the
following characteristics after discussion with the attending physician:
• cardiac arrhythmias
• pregnancy
➔Administration/network connection
➔Measuring mode