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

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3. SAFETY PRECAUTIONS
3.1 Safety precautions in these instructions for use
DANGER!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries will occur.
WARNING!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries may result.
CAUTION!
Used to identify a hazardous situation. If you fail to take note of this
information, minor to moderate injuries may result.
NOTICE!
Used to identify possible incorrect usage of the device. If you fail to
take note of this information, you may damage the device, or the
measuring results may be incorrect.
NOTE
Includes additional information about use of the device.
3.2 Basic safety precautions
Handling the device ►Please take note of the information in these instructions for use.
►Keep the instructions for use in a safe place. The instructions for use are a
component of the device and must be available at all times.
►In the interest of patient safety, you and your patients are obliged to report
serious events that occur in connection with this product to the manufac-
turer and the authority responsible in your country.
DANGER!
Risk of explosion
Do not use the device in an environment in which one of the following
gases has accumulated:
►oxygen
►flammable anesthetics
►other flammable substances/air mixtures
➔Safety precautions in these instructions for use
➔Basic safety precautions
➔Handling the device
➔Handling a wheeled stand
➔Preventing electric shock
➔Prevent injuries and infections
➔Preventing damage to device
➔Handling measuring results
➔Handling packaging material
➔Handling batteries and rechargeable batteries

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CAUTION!
Patient hazard, damage to device
►Additional devices which are connected to electrical medical devic-
es must provide evidence of compliance with the relevant IEC or ISO
standards (e.g. IEC 60950 for data-processing devices). Further-
more, all configurations must comply with the requirements of stan-
dards for medical systems (see IEC 60601-1-1 or Section 16 of
edition 3.1 of IEC 60601-1, respectively). Anyone connecting addi-
tional devices to electrical medical devices is considered a system
configurer and is therefore responsible for ensuring that the system
complies with the requirements of standards for systems. Your at-
tention is drawn to the fact that local laws take precedence over the
above-mentioned requirements of standards. In the event of any
queries, please contact your local specialist dealer or Technical
Service.
►Please have servicing and 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. Only have ser-
vicing and repairs performed by an authorized seca Service partner.
You can find service partners in your area at www.seca.com or by
sending an e-mail to servic[email protected].
►Only use original seca accessories and spare parts, otherwise seca
will not grant any warranty.
CAUTION!
Patient hazard, malfunction
►Keep other electrical medical devices, e.g. high-frequency surgical
devices, a minimum distance of approx. 1 meter away to prevent in-
correct measurements or wireless transmission interference.
►Keep HF devices such as cell phones a minimum distance of ap-
prox. 1 meter away to prevent incorrect measurements or wireless
transmission interference.
►The actual transmission output of HF equipment may require mini-
mum distances of more than 1 meter. Details can be found at
www.seca.com.
Handling a wheeled stand WARNING!
Injury from falling, damage to device
►When transporting the device on a wheeled stand, make sure that
all cables and tubes are stowed properly directly on the machine or
in the basket of the stand.
CAUTION!
Damage to device
►Do not pull on cables and tubes to move the equipment or wheeled
stand.
►Do not move the wheeled stand when the power cord of the device
is plugged into an electrical outlet.

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Preventing electric shock WARNING!
Electric shock
►Set up devices which can be operated with the electricity supply so
that the power supply socket is within easy reach and the power
supply can be disconnected quickly.
►Ensure that your local power supply matches the details on the
device.
►Connect this device only to a power supply with a protective earth
facility.
►Do not connect the device to a power supply network if there is any
uncertainty about whether the protective earth is functioning. In this
case, use the device exclusively in rechargeable battery mode.
►Do not connect the device to sockets that are switched by an on/off
switch or a dimmer.
►Never touch the power supply cable with wet hands.
►Do not use extension cables or power strips.
►Make sure that cables are not pinched or damaged by sharp edges.
►Make sure that cables do not come into contact with hot objects.
►Do not operate the device at an altitude of more than 3000 m above
sea level.
Prevent injuries and infections WARNING!
Injury from falls
►Ensure that the device is positioned firmly and level.
►Route connecting cables (if present) in such a way that neither user
nor patient can trip over them.
WARNING!
Risk of infection
►Before and after every measurement, wash your hands to reduce
the risk of cross-contamination and nosocomial infections.
►Hygienically reprocess the device regularly as described in the
respective 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.

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Preventing damage to device NOTICE!
Damage to device
►If liquids have penetrated the device, the device may not be opera-
tional for a short period. Allow the device to dry for an extended pe-
riod (e.g. overnight), before starting it up again.
►Switch off the device before you take the power supply connector
out of the power supply socket.
►If you are not going to use the device for an extended period, dis-
connect the power supply connector from the power supply socket
and remove the rechargeable battery (if present and removable).
Only then is the device de-energized.
►Make sure not to drop the device.
►Do not expose the device to any impacts or vibrations.
►Ensure that there is no heat source in the immediate vicinity. Do not
expose to direct sunlight. The excessive temperature could damage
the electronics.
►Ensure that the air openings of the device (if present) are not
covered.
►Perform function controls regularly as described in the relevant sec-
tion in this document. Do not operate the device if it is damaged or
not working properly.
►Avoid rapid temperature fluctuations. When the device is transport-
ed so that a temperature difference of more than 20 °C occurs, it
must stay turned off for at least 2 hours before it can be turned on
again. Otherwise, condensation water will form which can damage
the electronics.
►Use the device only in the intended ambient conditions.
►Store the device only in the intended storage conditions.
►Use only disinfectants free of chlorine and alcohol which are explic-
itly suitable for acrylic sheet and other sensitive surfaces (active in-
gredient: quaternary ammonium compounds, for example).
►Do not use aggressive or abrasive cleaning agents.
►Do not use organic solvents (e.g. white spirit or petroleum spirit).
►Use disinfectants including the active ingredient 70 % isopropanol
only for measuring accessories for measuring vital signs.
Handling measuring results CAUTION!
Patient hazard
In order to avoid misinterpretations, measuring results for medical use
must be displayed and used in SI units (weight: kilogrammes, length:
metres) only. Some devices offer the ability to display measuring
results in other units. This is only an additional function.
►Use the results exclusively in SI units.
►The use of measuring results in non-SI units is the sole responsibility
of the user.
NOTICE!
Inconsistent measuring results
►Before you electronically save measured values determined using
this device and use them further (e.g. in seca PC software or in an
EMR system), make sure that the measured values are plausible.
►If measured values are transmitted to seca PC software or an EMR
system, make sure prior to further use that the measured values are
plausible and are assigned to the correct patient.

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NOTICE!
Results not comparable to other devices
Results of bioelectric impedance measurements are not interchange-
able with measurements obtained from different manufacturers‘
devices. Follow-up measurements not performed on a seca device
may lead to inconsistent data and to misinterpreted measuring results.
►Ensure that follow-up measurements are also performed on a seca
device.
NOTE
For an overview of the parameters which can be determined using this
device, see the section entitled “Technical data\analysis parameters”.
If necessary, you can print out this overview and give it to your
patients (print-out from the device not possible).
Handling packaging material WARNING!
Risk of suffocation
Packaging material made of plastic foil (bags) is a choking hazard.
►Keep packaging material out of reach of children.
►In the event that the original packing material may not be available
anymore, only use plastic bags with security holes in order to reduce
the risk of suffocation. Use recyclable materials if possible.
NOTE
Keep the original packing material for future use (e.g. returning for
servicing).
Handling batteries and
rechargeable batteries
WARNING!
Personal injury as a result of improper handling
Batteries and rechargeable batteries contain harmful substances
which may explode if not handled properly.
►Do not try to recharge batteries.
►Do not expose (rechargeable) batteries to heat.
►Do not burn (rechargeable) batteries.
►If acid is leaking out, avoid contact with the skin, eyes and mucous
membranes. Rinse affected areas with plenty of clean water and
seek medical help at once.
NOTICE!
Damage to device and malfunctions with improper handling
►Only use the type of (rechargeable) battery specified in this
document.
►When replacing (rechargeable) batteries, always replace a complete
set at a time.
►Do not short-circuit (rechargeable) batteries.
►If you do not use the device for a long period of time, remove the
batteries (incl. rechargeable batteries). This prevents acid from leak-
ing into the device.
►If acid leaked into the device, discontinue use. Have the device
checked by an authorised seca Service partner and repaired if
necessary.

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4. Device overview
4.1 Monitor controls for seca mVSA 535/seca mBCA 525
NOTE
This section shows product versions. The functional scope of your
device may deviate from this.
➔Monitor controls for seca mVSA 535/seca mBCA 525
➔In-ear thermometer controls
➔Measuring mat controls (bioimpedance analysis)
➔Fields in the touchscreen display
➔Login/navigation: Buttons and symbols in the touchscreen display
➔Operating state: Symbols
➔Measuring: Buttons and symbols
➔Unsubmitted measurements list: Symbols
➔Markings on the device and on the type plate
➔Markings on the blood pressure cuff
➔Markings on the packaging
1
234 5 6 7 8 9
11
10
12
13
14 15 16
19
2221 23 24
20
17
18
seca mBCA 525:
secamVSA 535 (additional/deviating controls):

Device overview • 17
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No. Control Function
1Handle Transporting the device
2Touchscreen display Central control/display element
3ON/OFF button with LED
LED white: Device on
LED green: Device on standby
LED off: Device off
4Storage compartment
(seca mBCA 525 only)
Transporting/storing the measuring mat (bioimpedance analysis)
Data transmission: Monitor/measuring mat
Charge measuring mat rechargeable battery
5Power supply connection socket For connecting the power supply cable
6USB interface, 2 pcs
For transmitting data via a USB memory stick
For transmitting data between monitor and SmartBucket
For supplying SmartBucket with power
Connecting the scanner
7ISIS interface Advance feature for future system upgrade (currently no function)
8LAN interface
For integrating the device in a network, using with the
seca analytics 115 PC software or with the seca connect 103 software
for connection to an EMR system
9Rechargeable battery
compartment To take lithium-ion rechargeable battery supplied
10 Infrared interface Automatic data transmission: Monitor/measuring mat (alternative if no
WiFi available)
11 Inductive charging interface with
magnetic catch For charging measuring mat rechargeable battery (version-dependent)
12 seca 360° internal wireless module For connecting scales and length measuring devices from the
seca 360° wireless system
13 Internal WiFi module
• For integrating the device in a network (using with the
seca analytics 115 PC software or with the seca connect 103 software
for connection to an EMR system)
• For automatic transmission of data, monitor/measuring mat
14 SmartBucket (secamVSA 535
only)
For transporting/storing measuring equipment (bioimpedance analysis,
vital signs)
For storing consumables
Data transmission: Monitor/measuring mat
Charge measuring mat rechargeable battery
15 Connecting cable with
USB connector
For power supply and data transmission between monitor and
SmartBucket
16 Connection for temperature
measurement
For COVIDIENTM FILACTM 3000 temperature probes
• Blue: Oral/axillary measurement
• Red: Rectal measurement
17 Probe holder
For COVIDIENTM FILACTM 3000 temperature probes
• Blue: Oral/axillary measurement
• Red: Rectal measurement
18 Storage compartment for probe
covers Capacity: 2 packs for COVIDIENTM FILACTM 3000
19 Removable magazine holder for
probe covers Capacity: 2 magazines for COVIDIENTM GENIUS®3
20 Thermometer compartment For COVIDIENTM GENIUS®3 in-ear thermometer
21 Connection for temperature
measurement For COVIDIENTM GENIUS®3 in-ear thermometer
22 Sensor holder For SpO2 sensor
23 Connection for SpO2
measurement
Depending on version, to fit:
• Masimo SET® patient cables and sensors (not illustrated)
• seca patient cables and sensors (shown in illustration)
24 Connection for blood pressure
measurement For seca blood pressure cuffs

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4.2 In-ear thermometer controls
NOTE
The illustration shows one equipment example. The actual functional
scope of your device may deviate from this.
I
II
III
IV
VI
VIII
VII
V
No. Control Function
IThermometer COVIDIENTM GENIUS®3 in-ear thermometer
II Connection for temperature
measurement For COVIDIENTM GENIUS®3 in-ear thermometer
III Measuring head For measuring temperature in ear
IV Discard button Discard probe cover
VIn-ear thermometer display Serves as a secondary display. secamVSA 535 display takes priority
VI Switch unit button Switch between °C and °F
VII Measure button Press button to start measurement
VIII Pulse timer button Not relevant for secamVSA 535. Pulse rate is determined automatically by
the secamVSA 535

Device overview • 19
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4.3 Measuring mat controls (bioimpedance analysis)
medicalBody Composition Analyzer
A
B
C
D
E
F
G H
L
MJ
I
K
No. Control Function
ALEDs, electrodes on left
LED green: Electrode contact good
LED green, flashing: Measurement in progress
LED red: Electrode contact poor
BButton with LED,
patient position left
Enter patient position
LED green: seca patient file loaded, patient position selected
LED green, flashing: Measurement stopped
LED red: No seca patient file loaded
CStart button Start measurement
D, K Magnetic catch Fold up measuring mat for transport/storage
EButton with LED,
patient position right
Enter patient position
LED green: seca patient file loaded, patient position selected
LED green, flashing: Measurement stopped
LED red: No seca patient file loaded
FLEDs, electrodes on right
LED green: Electrode contact good
LED green, flashing: Measurement in progress
LED red: Electrode contact poor
GLED, WiFi
LED green: WiFi connection to monitor OK
LED green, flashing: WiFi connection being set up
LED red: No WiFi connection to monitor
LED off: WiFi deactivated
HLED, charge status
LED green: Rechargeable battery full
LED green, flashing: Rechargeable battery almost discharged, charge as
soon as possible
LED red: Rechargeable battery discharged
IElectrode connections Connect to electrodes
JElectrode cables Transmit signals from electrodes to the measuring mat
LInfrared interface Automatic data transmission: Monitor/measuring mat
Alternative if no WiFi available
MInductive charging interface
with magnetic catch Charge measuring mat rechargeable battery

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4.4 Fields in the touchscreen display
.
4.5 Login/navigation: Buttons and symbols in the touchscreen display
Status/error
messages
Battery charge
status/
connection status
Login/logout
field
Tab contents
Side
navigation bar
Bottom navigation bar
Button/symbol Meaning
Patient tab
Vital signs tab
BIA tab
Analysis tab
Open instructions for use
Instructions for use: Return to section
summary
Enter text or numbers
No input or input faulty
Select user account
Enter password