Seca mVSA 535 - Declaration of Conformity

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134 • secamVSA 535/seca mBCA 525

17-10-05-353-002g_10-2020 B

17.DECLARATION OF CONFORMITY

seca gmbh & co. kg hereby declares that the product meets the terms of the

applicable European directives. The unabridged declaration of conformity can

be found at: www.seca.com.

0123

Main Page

Default Chapter2
- Table of Contents2
Instructions for Use for Seca Mvsa5
Seca Mbca 525
About this Document5
Description of Device6
- Intended Use for the Seca Mvsa 5356
- Intended Use for the Seca Mbca 5256
- Description of Function7
- User Qualification10
  - Administration/Network Connection10
  - Measuring Mode10
- Contraindications10
Safety Precautions11
- Safety Precautions in These Instructions for Use11
- Basic Safety Precautions11
Device Overview16
- Monitor Controls for Seca Mvsa 535/ Seca Mbca 52516
- In-Ear Thermometer Controls18
- Measuring Mat Controls (Bioimpedance Analysis)19
- Fields in the Touchscreen Display20
- Login/Navigation: Buttons and Symbols in the Touchscreen Display20
- Operating State: Symbols21
- Measuring: Buttons and Symbols23
- Unsubmitted Measurements List: Symbols27
- Markings on the Device and on the Type Plate28
- Markings on the Blood Pressure Cuff30
- Markings on the Packaging31
- Other Symbols31
Starting up the Device32
- Scope of Delivery32
- Setting up Device33
- Establishing a Power Supply38
- Charging Rechargeable Batteries38
- Setting the Date and Time39
- Initial Login40
- Configuration Options40
Operation41
- Switching the System On/Off41
- Managing Seca Patient Files44
- Measuring Vital Signs49
- Measuring Bioimpedance73
- Adding Weight and Height80
- Analyzing Measurement84
Operation When Connected to an EMR91
- System91
- Switching on the Device91
- Measuring92
  - Measuring with an Active Connection to an EMR System92
  - Measuring with an Interrupted Connection to an EMR System92
- Logging in with EMR User ID94
  - Scanning EMR User ID (Recommended)94
  - Entering EMR User ID Manually94
- Calling up Patient Data from the EMR System95
  - Scanning Patient ID (Recommended)95
  - Manually Entering Patient ID96
- Saving Measurements in the EMR System97
Hygiene Treatment102
- Cleaning102
- Disinfecting104
- Sterilizing104
- Removing/Fitting Probe Holder (Devices with Temperature Probe)105
  - Removing the Probe Holder105
  - Fitting the Probe Holder105
- Removing/Fitting the Magazine Holder (Devices with In-Ear Thermometer)106
  - Removing the Magazine Holder106
  - Fitting the Magazine Holder106
Function Check107
- Device107
- Covidien Genius107
  - In-Ear Thermometer107
Servicing107
- Covidien Tm Genius108
  - In-Ear Thermometer108
Troubleshooting109
- Monitor109
- Measuring Mat110
- Bioimpedance Measurement111
- Vital Signs Measurement112
- Network Connection116
- Connection to the Seca Analytics 115 Software117
- EMR System Connection Via Seca Connect 103 Software118
- Seca 360° Proximity Connection119
- Seca 360° Wireless Connection119
Technical Data120
- Monitor120
- Monitor Interfaces and Network Ports121
  - Interfaces and Network Ports121
  - Recommended Wifi Settings121
- Measuring Mat122
- Bioimpedance Measurement122
- Vital Signs Measurement124
- Analysis Parameters129
- Analysis Modules130
- Seca 360° Wireless System130
- Standards and Directives131
Optional Accessories and Spare Parts131
Compatible Seca Products132
Disposal133
- Measuring Mat and Device133
- Batteries and Rechargeable Batteries133
- Consumables133
Warranty133
Declaration of Conformity134
For Administrators: Configuring135
Seca Mvsa 535 /Seca Mbca 525135
Preparing Configuration135
- Administrator Login135
- Configuration Options137
  - Network Functions137
  - Overview of Access Rights137
User Accounts138
- Activating Initial User Accounts138
  - Changing the Password for the Admin User Account138
  - Assigning a Password to the User User Account139
- Working with User Accounts140
Making Settings for Measuring Mode142
- Making Regional Settings142
- Setting Display Brightness and Volume143
- Calibrating the Touchscreen Display144
- Setting Units of Measurement146
- Deactivating Analysis Modules147
- Making Presets for Vital Signs Measurement148
Managing System Components157
- Viewing System Information157
- Updating the Monitor Software158
- Updating the Measuring Mat Software159
- Retrofitting the Smartbucket160
  - (Seca Mbca 525 Only)160
- Retrofitting the Measuring Mat (Seca Mvsa 535 Only)161
- Retrofitting the In-Ear Thermometer (Seca Mvsa 535 Only)162
- Data Export and Backup163
  - Exporting Patient and User Data Manually163
  - Restoring Patient and User Data Manually164
- Power Management165
Setting up Peripherals166
- Setting up a LAN Connection to the Network (Stationary Operation)166
- Setting up a Wifi Connection (Mobile Operation)170
- Setting up a Connection to the Seca Analytics 115 PC Software173
- Setting up a Seca 360° Proximity Connection178
- Setting up a Seca 360° Wireless Connection181
Connecting to an EMR System184
- Information about User and Patient Data184
- Assigning a Clear Device Name185
- Setting up a Connection to the Seca Connect 103 Software186
  - Entering Connection Data186
  - Making Workflow Settings187
- Configuring Data Transfer to the EMR System189
- Use of Certificates189
- Summary: Device Characteristics When Connected to EMR System189
Factory Settings190
- Overview of Factory Settings190
- Resetting the Device191
- Resetting the User Interface192
- Exporting the System Log/Audit Trail192
- Enabling VNC Access193

Seca mVSA 535 - Declaration of Conformity

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