Seca mVSA 535 User manual

Software version 2.0 from Build 1444
Art no: 17-10-05-368-002c_12-2021 B
seca mVSA 535
Instructions for use

2 •
Instructions for use for seca mVSA 535 . . . . . . 5
1. About this document . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Description of device . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Intended use seca mVSA 535 . . . . . . . . . . . . . . 6
2.2 Restrictions on use of seca mVSA 535 . . . . . . . 6
2.3 Functional description . . . . . . . . . . . . . . . . . . . . 6
Device components . . . . . . . . . . . . . . . . . . . . 7
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . 7
Vital signs measurement . . . . . . . . . . . . . . . . . 7
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Weight and height. . . . . . . . . . . . . . . . . . . . . . 7
User IDs of EMR systems . . . . . . . . . . . . . . . . 7
seca patient files . . . . . . . . . . . . . . . . . . . . . . . 7
Patient data from EMR systems . . . . . . . . . . . 7
Measured results . . . . . . . . . . . . . . . . . . . . . . 7
Data transmission and network functions . . . . 8
Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 User qualification . . . . . . . . . . . . . . . . . . . . . . . . 8
Administration/network connection. . . . . . . . . 8
Measuring mode. . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . 8
3. Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1 Terms and definitions. . . . . . . . . . . . . . . . . . . . . 9
3.2 Safety precautions in these instructions for use . 9
3.3 Basic safety precautions . . . . . . . . . . . . . . . . . 10
Handling the device . . . . . . . . . . . . . . . . . . . 10
Handling a wheeled stand. . . . . . . . . . . . . . . 11
Preventing electric shock . . . . . . . . . . . . . . . 11
Prevent injuries and infections. . . . . . . . . . . . 11
Preventing damage to device . . . . . . . . . . . . 12
Handling measured results . . . . . . . . . . . . . . 12
Handling packaging material. . . . . . . . . . . . . 13
Handling batteries and rechargeable
batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4. Device overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1 Monitor controls for seca mVSA 535 . . . . . . . . 15
4.2 Fields in the touchscreen display . . . . . . . . . . . 17
4.3 Login/navigation: Keys and symbols in the
touchscreen display. . . . . . . . . . . . . . . . . . . . . 17
4.4 Operating state: Symbols. . . . . . . . . . . . . . . . . 18
4.5 Measuring: Keys and symbols . . . . . . . . . . . . . 20
Patient tab . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Vital signs tab . . . . . . . . . . . . . . . . . . . . . . . . 20
Clinical observations tab . . . . . . . . . . . . . . . . 21
Analysis tab . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.6 Unsubmitted measurements list: Symbols . . . . 22
4.7 Markings on the device and on the type plate . 23
4.8 Markings on the blood pressure cuff . . . . . . . . 25
4.9 Markings on the packaging . . . . . . . . . . . . . . . 26
4.10 Other symbols . . . . . . . . . . . . . . . . . . . . . . . . 26
5. Starting up the device . . . . . . . . . . . . . . . . . . . . . . . 27
5.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . 27
5.2 Setting up device. . . . . . . . . . . . . . . . . . . . . . . 28
Connecting the SmartBucket . . . . . . . . . . . . 28
Connecting the blood pressure cuff . . . . . . . 29
Connecting the temperature probe . . . . . . . . 29
Connecting the Masimo SET® SpO2 sensor . 30
5.3 Establishing a power supply. . . . . . . . . . . . . . . 30
5.4 Charging rechargeable battery. . . . . . . . . . . . . 31
5.5 Setting the date and time. . . . . . . . . . . . . . . . . 31
5.6 Initial login . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.7 Configuration options. . . . . . . . . . . . . . . . . . . . 32
6. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.1 Switching the system on/off. . . . . . . . . . . . . . . 33
Switching on. . . . . . . . . . . . . . . . . . . . . . . . . 33
Logging in. . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Logging out/switching user. . . . . . . . . . . . . . 34
Saving power/switching off. . . . . . . . . . . . . . 35
6.2 Managing seca patient files . . . . . . . . . . . . . . . 36
Creating a seca patient file . . . . . . . . . . . . . . 36
Calling up a seca patient file . . . . . . . . . . . . . 38
Editing a seca patient file . . . . . . . . . . . . . . . 38
Exporting a seca patient file . . . . . . . . . . . . . 39
Deleting a seca patient file . . . . . . . . . . . . . . 39
6.3 Measuring vital signs . . . . . . . . . . . . . . . . . . . . 40
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 40
Measuring blood pressure . . . . . . . . . . . . . . 41
Measuring temperature, oral/axillary
(COVIDIENTM FILACTM 3000, blue). . . . . . . . 46
Measuring temperature, rectal
(COVIDIENTM FILACTM 3000 red) . . . . . . . . . 49
Reading off pulse rate. . . . . . . . . . . . . . . . . . 52
Measuring oxygen saturation (SpO2). . . . . . . 53
Weight and height. . . . . . . . . . . . . . . . . . . . . 57
Adding a comment . . . . . . . . . . . . . . . . . . . . 57
Stopping a measurement . . . . . . . . . . . . . . . 58
Assigning anonymous measurement to a
seca patient file. . . . . . . . . . . . . . . . . . . . . . . 58
6.4 Adding weight and height . . . . . . . . . . . . . . . . 59
Receiving weight and height
(seca 360° proximity) . . . . . . . . . . . . . . . . . . . 59
Entering weight and height manually. . . . . . . 60
6.5 Entering vital signs manually . . . . . . . . . . . . . . 61
Entering blood pressure manually . . . . . . . . . 61
Entering temperature manually . . . . . . . . . . . 62
Entering pulse rate manually . . . . . . . . . . . . . 63
Entering oxygen saturation manually. . . . . . . 64
6.6 Analyzing measurement. . . . . . . . . . . . . . . . . . 66
Viewing current measured results . . . . . . . . . 66
Analyzing vital signs (history) . . . . . . . . . . . . . 67
7. Operation when connected to an EMR system . . . 69
7.1 Switching on the device. . . . . . . . . . . . . . . . . . 69
7.2 Measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Measuring with an active connection to an
EMR system . . . . . . . . . . . . . . . . . . . . . . . . . 70
Measuring with an interrupted connection to
an EMR system . . . . . . . . . . . . . . . . . . . . . . 70
7.3 Logging in with EMR system user ID . . . . . . . . 72
Scanning EMR system user ID
(recommended) . . . . . . . . . . . . . . . . . . . . . . 72
Entering EMR system user ID manually. . . . . 72
7.4 Calling up patient data from the EMR system. . 73
Scanning patient ID (recommended) . . . . . . . 73
Manually entering patient ID . . . . . . . . . . . . . 74
7.5 Saving measurements in the EMR system . . . . 75
Submitting the measurement directly to the
EMR system . . . . . . . . . . . . . . . . . . . . . . . . . 75
Saving measurement temporarily and
submitting it later . . . . . . . . . . . . . . . . . . . . . 75
Using the Unsubmitted measurements list . . 76
7.6 Recording clinical observations . . . . . . . . . . . . 80
TABLE OF CONTENTS

• 3
English
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 80
Entering/amending clinical observations . . . . 80
8. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . . . 82
8.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
8.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8.3 Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8.4 Removing/fitting probe holder (devices with
temperature probe) . . . . . . . . . . . . . . . . . . . . . 84
Removing the probe holder. . . . . . . . . . . . . . 85
Fitting the probe holder. . . . . . . . . . . . . . . . . 85
9. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
10. Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
11. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
11.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
11.2 Vital signs measurement . . . . . . . . . . . . . . . . 88
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Blood pressure measurement. . . . . . . . . . . . 88
COVIDIENTM FILACTM 3000 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . . . 89
SpO2 measurement . . . . . . . . . . . . . . . . . . . 89
11.3 Network connection. . . . . . . . . . . . . . . . . . . . 90
11.4 EMR system connection via seca connect 103
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
11.5 Clinical observations . . . . . . . . . . . . . . . . . . . 92
11.6 seca 360°proximity connection . . . . . . . . . . . 92
12. Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
12.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
12.2 Monitor interfaces and network ports. . . . . . . 94
Interfaces and network ports . . . . . . . . . . . . 94
Recommended WiFi settings . . . . . . . . . . . . 94
12.3 Vital signs measurement . . . . . . . . . . . . . . . . 95
Blood pressure measurement. . . . . . . . . . . . 95
COVIDIENTM FILACTM 3000 temperature
measurement . . . . . . . . . . . . . . . . . . . . . . . . 96
Masimo SET® SpO2 measurement . . . . . . . . 97
Manual input of vital signs. . . . . . . . . . . . . . . 98
12.4 Analysis parameters. . . . . . . . . . . . . . . . . . . . 99
12.5 Analysis modules . . . . . . . . . . . . . . . . . . . . . 100
12.6 Standards and directives . . . . . . . . . . . . . . . 101
13. Optional accessories and spare parts . . . . . . . . 101
14. Compatible seca products. . . . . . . . . . . . . . . . . . 102
15. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
15.1 Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
15.2 Batteries and rechargeable batteries . . . . . . 103
15.3 Consumables. . . . . . . . . . . . . . . . . . . . . . . . 103
16. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
17. Declaration of conformity . . . . . . . . . . . . . . . . . . 104

4 •
For administrators: Configuring
seca mVSA 535 . . . . . . . . . . . . . . . . . . . . . . . . . 105
1. Preparing configuration . . . . . . . . . . . . . . . . . . . . . 105
1.1 Administrator login. . . . . . . . . . . . . . . . . . . . . 105
1.2 Configuration options. . . . . . . . . . . . . . . . . . . 107
Network functions. . . . . . . . . . . . . . . . . . . . 107
Overview of access rights . . . . . . . . . . . . . . 107
2. User accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
2.1 Activating initial user accounts . . . . . . . . . . . . 108
Changing the password for the “admin” user
account . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Assigning a password to the “user” user
account . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
2.2 Working with user accounts. . . . . . . . . . . . . . 110
Editing user accounts . . . . . . . . . . . . . . . . . 110
3. Making settings for measuring mode. . . . . . . . . . 112
3.1 Making regional settings . . . . . . . . . . . . . . . . 112
3.2 Setting display brightness and volume . . . . . . 113
3.3 Calibrating the touchscreen display . . . . . . . . 114
3.4 Setting units of measurement. . . . . . . . . . . . . 116
3.5 Deactivating analysis modules . . . . . . . . . . . . 117
3.6 Making presets for vital signs measurement. . 118
Presets for blood pressure . . . . . . . . . . . . . 118
Presets for SpO2 . . . . . . . . . . . . . . . . . . . . 122
Presets for temperature
(COVIDIENTM FILACTM 3000 only) . . . . . . . 123
Selecting color mode for Vital signs tab . . . 125
4. Managing system components . . . . . . . . . . . . . . . 126
4.1 Viewing system information . . . . . . . . . . . . . . 126
4.2 Updating the monitor software. . . . . . . . . . . . 127
4.3 Data export and backup . . . . . . . . . . . . . . . . 128
Exporting patient and user data manually . . 128
Restoring patient and user data manually . . 129
4.4 Power management. . . . . . . . . . . . . . . . . . . . 130
5. Setting up peripherals . . . . . . . . . . . . . . . . . . . . . . 131
5.1 Setting up a LAN connection to the network
(stationary operation) . . . . . . . . . . . . . . . . . . . 131
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 131
Activating the LAN connection . . . . . . . . . . 131
Deactivating the LAN connection . . . . . . . . 133
5.2 Setting up a WiFi connection
(mobile operation) . . . . . . . . . . . . . . . . . . . . . 135
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 135
Activating the WiFi connection . . . . . . . . . . 135
Deactivating the WiFi connection . . . . . . . . 136
5.3 Setting up a seca 360° proximity connection . 138
6. Connecting to an EMR system . . . . . . . . . . . . . . . 141
6.1 Information about user and patient data. . . . . 141
6.2 Assigning a clear device name. . . . . . . . . . . . 142
6.3 Setting up a connection to the seca connect 103
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Entering connection data . . . . . . . . . . . . . . 143
Making workflow settings . . . . . . . . . . . . . . 144
6.4 Configuring data transfer to the EMR system . 145
6.5 Use of certificates . . . . . . . . . . . . . . . . . . . . . 146
6.6 Summary: Device behavior when connected to
an EMR system . . . . . . . . . . . . . . . . . . . . . . . 146
7. Clinical observations . . . . . . . . . . . . . . . . . . . . . . . 147
7.1 Specified settings for the configuration file . . . 147
Options for input. . . . . . . . . . . . . . . . . . . . . 147
Definition of mandatory fields . . . . . . . . . . . 147
Language selection. . . . . . . . . . . . . . . . . . . 147
7.2 Loading the configuration file onto the device
and updating it . . . . . . . . . . . . . . . . . . . . . . . 148
7.3 Deleting configuration file . . . . . . . . . . . . . . . . 148
8. Factory settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8.1 Overview of factory settings . . . . . . . . . . . . . . 149
8.2 Resetting the device . . . . . . . . . . . . . . . . . . . 150
8.3 Resetting the user interface . . . . . . . . . . . . . . 150
8.4 Exporting the system log/audit trail . . . . . . . . 151
8.5 Enabling VNC access . . . . . . . . . . . . . . . . . . 152

Instructions for use for seca mVSA 535 • 5
English
17-10-05-368-002c_12-2021B
INSTRUCTIONS FOR USE FOR seca mVSA 535
English
Software version: 2.0 from Build 1444
Article number of this document: 17-10-05-368-002c_12-2021B
1. ABOUT THIS DOCUMENT
NOTE
This document describes the maximal equipment of the
secamVSA 535 product family: measurement of blood pressure, tem-
perature, oxygen saturation and bioimpedance. Depending on the
actual equipment of your device, some of this information may not be
relevant to your device. Pay attention to the information in this docu-
ment 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
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
17-10-05-368-002c_12-2021B
2. DESCRIPTION OF DEVICE
2.1 Intended use seca mVSA 535
The medical Vital Signs Analyzer secamVSA 535 is a spot-check device used
for noninvasive, discontinuous measurement and display of NiBP (blood
pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body tem-
perature) and PR (pulse rate).
The vital signs monitor model secamVSA 535 is mainly used in inpatient facili-
ties (hospitals, medical practices and care facilities) in accordance with
national regulations and is intended to be used on adult and pediatric individ-
uals (3 years of age or older).
The secamVSA 535 can be used in conjunction with an optional seca server
software accessory for reception from and data transfer to external Hospital
Information Systems.
lf used in conjunction with seca medical weight and height measurement
devices the secamVSA 535 can receive and display weight and height values.
2.2 Restrictions on use of seca mVSA 535
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 electrocauter-
ization.
This device is not suitable for individuals who are connected to electronic life-
support systems, for example artificial heart-lung machine.
2.3 Functional description
➔Intended use seca mVSA 535
➔Functional description
➔User qualification
➔Contraindications
➔Device components
➔Power supply
➔Vital signs measurement
➔Alarms
➔Weight and height
➔User IDs of EMR systems
➔seca patient files
➔Patient data from EMR systems
➔Measured results
➔Data transmission and network functions
➔Compatibility

Description of device • 7
English
17-10-05-368-002c_12-2021B
Device components The secamVSA 535 consists of a monitor and a SmartBucket.
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 maximal configuration, the vital signs blood pressure, body tempera-
ture, pulse rate and oxygen saturation can be recorded. Your version of the
device may have a more limited 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.
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)
or rectal (red temperature probe) procedure.
Oxygen saturation is measured with Masimo SET® and with the correspond-
ing SpO2 sensors and patient cables.
Depending on device version, pulse rate is determined using either oxygen
saturation or blood pressure.
Alternatively, a patient’s vital signs can be entered manually.
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 with an internal interface module or a seca 452
external interface module can transmit measured results to the device via
LAN or WiFi.
Alternatively, the patient's weight and height can be recorded manually.
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 stand-alone mode, measured results are managed in seca patient files.
seca patient files can be set up, edited, exported and deleted directly on the
device.
Patient data from EMR systems Depending on the EMR system in question, patient data from EMR systems
can be used by means of a connection to the seca connect 103 software.
Measured results Measured results for the vital signs blood pressure (NIBP), temperature
(TEMP), pulse rate (PR) and oxygen saturation (SpO2) are displayed in
graphical form.

8 • secamVSA 535
17-10-05-368-002c_12-2021B
Data transmission and network
functions
The device can be integrated into a network via a LAN interface or via WiFi in
order to use the following functions:
• 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 measured results to the EMR system
•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
Measured 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.
Compatibility seca connect 103 software
This device (software version 2.0, Build 1444 or higher) is only compatible
with version 3.1 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 2.0, Build 1444 or higher) is only compatible
with interface modules on which firmware version R1.3 Build 79 or higher is
installed.
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 sys-
tem. People operating the device must be informed about these effects.
2.5 Contraindications
This device is not suitable for persons with the following characteristics:
• Cramps
• Tremors
➔Administration/network connection
➔Measuring mode

Safety precautions • 9
English
17-10-05-368-002c_12-2021B
3. SAFETY PRECAUTIONS
3.1 Terms and definitions
3.2 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
measured results may be incorrect.
NOTE
Includes additional information about use of the device.
➔Terms and definitions
➔Safety precautions in these instructions for use
➔Basic safety precautions
Term Definition
Patient
The use of this device is focused on but not
limited to a medical environment. To keep
wording concise a person being measured with
this device is referred to as „patient“.
User
A person with access rights to operate the device
as follows:
Performing measurements
Anlayzing measurment results
Saving data to a patient database
Administrator
A person with access rights to operate the device
as follows:
Setting up the device
Setting up network connections
Modifying settings as necessary

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3.3 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
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 Ser-
vice.
►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 servi[email protected].
►Only use original seca accessories and spare parts, otherwise seca
will not grant any warranty.
➔Handling the device
➔Handling a wheeled stand
➔Preventing electric shock
➔Prevent injuries and infections
➔Preventing damage to device
➔Handling measured results
➔Handling packaging material
➔Handling batteries and rechargeable batteries

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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.
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.

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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.
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 measured 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.

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NOTICE!
Inconsistent measuring results
►Before you electronically save measured values determined using
this device and use them further (e.g. in seca software or in an EMR
system), make sure that the measured values are plausible.
►If measured values are transmitted to seca software or an EMR sys-
tem, make sure prior to further use that the measured values are
plausible and are assigned to the correct patient.
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
(rechargeable) batteries. This prevents acid from leaking 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
➔Monitor controls for seca mVSA 535
➔Fields in the touchscreen display
➔Login/navigation: Keys and symbols in the touchscreen display
➔Operating state: Symbols
➔Measuring: Keys 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
➔Other symbols

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4.1 Monitor controls for seca mVSA 535
NOTE
This section shows product versions. The functional scope of your
device may deviate from this.
1
2345
6
78910
11
12 14 15 16
13 17
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
4Connection for temperature
measurement
For COVIDIENTM FILACTM 3000 temperature probes
• Blue: Oral/axillary measurement
• Red: Rectal measurement
5Probe holder
For COVIDIENTM FILACTM 3000 temperature probes
• Blue: Oral/axillary measurement
• Red: Rectal measurement
6Storage compartment for
probe covers Capacity: 2 packs for COVIDIENTM FILACTM 3000
7USB port, 2 pcs
For transmitting data via a USB memory stick
Transmit data between monitor and SmartBucket
Supply SmartBucket with power
Connect a scanner
8ISIS port Advance feature for future system upgrade (currently no function)

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9LAN port For integrating the device in a network, using with the seca connect 103
software for connection to an EMR system
10 Rechargeable battery
compartment To take lithium-ion rechargeable battery supplied
11 Internal WiFi module For integrating the device in a network (using with the seca connect 103
software for connection to an EMR system)
12 SmartBucket Transporting/storing measuring equipment (vital signs)
For storing consumables
13 Connecting cable with USB
connector Power supply and data transmission between monitor and SmartBucket
14 Holder For SpO2 sensor
15 Connection for SpO2
measurement Masimo SET® patient cables and sensors
16 Connection for blood pressure
measurement For seca blood pressure cuffs
17 Power supply socket For connecting the power supply cable
No. Control Function

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4.2 Fields in the touchscreen display
..
4.3 Login/navigation: Keys 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
Key/symbol Meaning
Patient tab
Vital signs tab
Clinical observations 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

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4.4 Operating state: Symbols
Operating state: Symbols in the touchscreen display
Enter password
• Navigation: Confirm entry
• Measuring: Save measurement
Process running
Key available
Key pressed
Key not available
Navigate to the left/right
Navigate up/down
One or more items from list selected/not
selected
Alternative from list selected/not selected
Return to previous screen
Log in user
Log out/switch user
Key/symbol Meaning
Login
Logout
Symbol Operating state
Monitor:
Controls permanently on: Rechargeable
battery charge status (%)
Controls flashing: Rechargeable battery
charging
Monitor:
Controls permanently on: Rechargeable
battery full
Controls flashing consecutively:
Rechargeable battery charging
Monitor: Rechargeable battery discharged

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LAN connection set up:
on/off
WiFi connection set up:
on/off
seca connect 103 ()EMR:
connection active
seca connect 103 (EMR):
connection interrupted
Pop-up window:
Information for the user
Pop-up window:
Error message
Pop-up window:
Setting option for the user
Error message during vital signs
measurement
Symbol Operating state

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4.5 Measuring: Keys and symbols
Patient tab
Vital signs tab
➔Patient tab
➔Vital signs tab
➔Clinical observations tab
➔Analysis tab
Key/symbol Meaning
Search for seca patient file
Switch sorting direction
Edit seca patient file
Export seca patient file
Delete seca patient file
Adopt value from previous measurement
Close seca patient file, changes will not be
saved
Key/symbol Meaning
Blood pressure measured non-invasively
Start blood pressure measurement
Blood pressure measurement in progress
Blood pressure:
Multiple measurement:
First measurement will be discarded
Blood pressure:
Multiple measurement:
Waiting time until next part-measurement
running
Blood pressure:
Systolic/diastolic pressure
NIBP
SYS/DIA